Pain Pract. 2024 Jan;24(1):8-17. Expectations of treatment outcome in complex cases of patients with chronic pain: A study on the DATAPAIN cohort
Sophie Waardenburg, Nelleke de Meij, Sander M J van Kuijk, Jan Van Zundert, Brigitte A Brouwer
PMID: 37477420
Abstract Background: A better insight in how the biopsychosocial factors influence patient outcome(s) may provide information that helps selecting the optimal pain management for a specific group. Methods: Categorization was made in the prospective DATAPAIN registry, in which patients with pain severity (Numeric Rating Scale [NRS]: 7-10), depression or anxiety (Hospital Anxiety and Depression Scale: > 10), and pain catastrophizing (Pain Catastrophizing Scale: > 31) were identified as complex cases. Patient outcomes; treatment satisfaction on the Patient Global Impression of Change (PGIC), pain relief (NRS), pain interference on the Brief Pain Inventory (BPI) and quality of life indicator General Perceived Health (GPH) were evaluated. Logistic regression analyzed if belonging to the complex cases showed modification in the outcome of the PGIC and GPH. Linear regression was observed if complex cases differed in average reduction in pain relief and interference compared to non-complex cases. Results: 1637 patients were included, of which 345 (21.08%) were considered complex cases. The changes in scores of pain relief and BPI active subscale were not significantly different between groups. The BPI affective subscale had a different change in score (-0.509; p: 0.002). The complex cases had an odds ratio (OR) of 0.59 (95% confidence interval [CI]: 0.36-0.77) on treatment satisfaction compared to non-complex cases, and an OR of 0.28 (95% CI: 0.11-0.56) on the GPH. Conclusion: When treating patients with complex cases, desired treatment outcome(s) should be recognized by specialists and patients, as these may be less likely to occur.
Int J Artif Organs. 2024 Jan;47(1):25-34. Inter-institutional analysis of the outcome after postcardiotomy veno-arterial extracorporeal membrane oxygenation
Fausto Biancari, Timo Mäkikallio, Antonio Loforte, Alexander Kaserer, Vito G Ruggieri, Sung-Min Cho, Jin Kook Kang, Magnus Dalén, Henryk Welp, Kristján Jónsson, Sigurdur Ragnarsson, Francisco J Hernández Pérez, Giuseppe Gatti, Khalid Alkhamees, Antonio Fiore, Andrea Lechiancole, Stefano Rosato, Cristiano Spadaccio, Matteo Pettinari, Andrea Perrotti, Sebastian D Sahli, Camilla L'Acqua, Amr A Arafat, Monirah A Albabtain, Mohammed M AlBarak, Mohamed Laimoud, Ilija Djordjevic, Ihor Krasivskyi, Robertas Samalavicius, Agne Jankuviene, Marta Alonso-Fernandez-Gatta, Markus J Wilhelm, Tatu Juvonen, Giovanni Mariscalco
PMID: 38053227 Abstract Introduction: Patients requiring postcardiotomy veno-arterial extracorporeal membrane oxygenation (V-A-ECMO) have a high risk of early mortality. In this analysis, we evaluated whether any interinstitutional difference exists in the results of postcardiotomy V-A-ECMO. Methods: Studies on postcardiotomy V-A-ECMO were identified through a systematic review for individual patient data (IPD) meta-analysis. Analysis of interinstitutional results was performed using direct standardization, estimation of observed/expected in-hospital mortality ratio and propensity score matching. Results: Systematic review of the literature yielded 31 studies. Data from 10 studies on 1269 patients treated at 25 hospitals were available for the present analysis. In-hospital mortality was 66.7%. The relative risk of in-hospital mortality was significantly higher in six hospitals. Observed versus expected in-hospital mortality ratio showed that four hospitals were outliers with significantly increased mortality rates, and one hospital had significantly lower in-hospital mortality rate. Participating hospitals were classified as underperforming and overperforming hospitals if their observed/expected in-hospital mortality was higher or lower than 1.0, respectively. Among 395 propensity score matched pairs, the overperforming hospitals had significantly lower in-hospital mortality (60.3% vs 71.4%, p = 0.001) than underperforming hospitals. Low annual volume of postcardiotomy V-A-ECMO tended to be predictive of poor outcome only when adjusted for patients' risk profile. Conclusions: In-hospital mortality after postcardiotomy V-A-ECMO differed significantly between participating hospitals. These findings suggest that in many centers there is room for improvement of the results of postcardiotomy V-A-ECMO.
Catheter Cardiovasc Interv. 2023 Jan 8. External validation of the PROGRESS-CTO perforation risk score: Individual patient data pooled analysis of three registries
Bahadir Simsek, Peter Tajti, Mauro Carlino, Soledad Ojeda, Manuel Pan, Stephane Rinfret, Evangelia Vemmou, Spyridon Kostantinis, Ilias Nikolakopoulos, Judit Karacsonyi, Athanasios Rempakos, Joseph A Dens, Pierfrancesco Agostoni, Khaldoon Alaswad, Michael Megaly, Alexandre Avran, James W Choi, Farouc A Jaffer, Darshan Doshi, Dimitri Karmpaliotis, Jaikirshan J Khatri, Paul Knaapen, Alessio La Manna, James C Spratt, Masaki Tanabe, Simon Walsh, Olga C Mastrodemos, Salman Allana, Bavana V Rangan, Omer Goktekin, Sevket Gorgulu, Paul Poommipanit, Kathleen E Kearney, William L Lombardi, J Aaron Grantham, Kambis Mashayekhi, Emmanouil S Brilakis, Lorenzo Azzalini
PMID: 36617391 Abstract Background: Coronary artery perforation is one of the most feared and common complications of chronic total occlusion (CTO) percutaneous coronary intervention (PCI).
Methods: To assess the usefulness of the recently developed PROGRESS-CTO (NCT02061436) perforation risk score in independent cohorts. Individual patient-level data pooled analysis of three registries was performed. Results: Of the 4566 patients who underwent CTO PCI at 25 centers, 196 (4.2%) had coronary artery perforation. Patients with perforations were older (69 ± 10 vs. 65 ± 10, p 0.001), more likely to be women (19% vs. 13%, p = 0.009), more likely to have a history of prior coronary artery bypass graft (34% vs. 20%, p 0.001), and unfavorable angiographic characteristics such as blunt stump (62% vs. 48%, p 0.001), proximal cap ambiguity (52% vs. 34%, p 0.001), and moderate-severe calcification (60% vs. 49%, p = 0.002). Technical success was lower in patients with perforations (73% vs. 88%, p 0.001). The area under the receiver operating characteristic curve of the PROGRESS-CTO perforation risk model was 0.76 (95% confidence interval [CI], 0.72-0.79), with good calibration (Hosmer-Lemeshow p = 0.97). We found that the CTO PCI perforation risk increased with higher PROGRESS-CTO perforation scores: 0.3% (score 0), 2.3% (score 1), 3.1% (score 2), 5.5% (score 3), 7.5% (score 4), 14.6% (score 5). Conclusion: Given the good discriminative performance, calibration, and the ease of calculation, the PROGRESS-CTO perforation score may facilitate assessment of the risk of perforation in patients undergoing CTO PCI.
Int J Drug Policy. 2023 Jan:111:101670. Empfehlungen zur Hepatitis Versorgung bei Drogenkonsumierenden
Jason Grebely, Geert Robaeys, Philip Bruggmann, Alessio Aghemo, Markus Backmund, Julie Bruneau, Jude Byrne, Olav Dalgard, Jordan J Feld, Margaret Hellard, Matthew Hickman, Achim Kautz, Alain Litwin, Andrew R Lloyd, Stefan Mauss, Maria Prins, Tracy Swan, Martin Schaefer, Lynn E Taylor, Gregory J Dore; im Namen vom International Network on Hepatitis care in Substance Users
PMID: 26749563
No abstract available
Int J Drug Policy. 2023 Jan:111:101669. Recommandations pour la prise en charge de l'infection par le virus de l'hépatite C chez les usagers de drogues par injection
Jason Grebely, Geert Robaeys, Philip Bruggmann, Alessio Aghemo, Markus Backmund, Julie Bruneau, Jude Byrne, Olav Dalgard, Jordan J Feld, Margaret Hellard, Matthew Hickman, Achim Kautz, Alain Litwin, Andrew R Lloyd, Stefan Mauss, Maria Prins, Tracy Swan, Martin Schaefer, Lynn E Taylor, Gregory J Dore
PMID: 26847504
No abstract available
Arch Dis Child Fetal Neonatal Ed. 2023 Jan;108(1):20-25. Short-term pulmonary and systemic effects of hydrocortisone initiated 7-14 days after birth in ventilated very preterm infants: a secondary analysis of a randomised controlled trial
Nienke M Halbmeijer, Wes Onland, Filip Cools, Andre Kroon, Marja van der Heide-Jalving, Peter Dijk, Henrica L M van Straaten, Arjan B Te Pas, Thilo Mohns, Els Bruneel, Arno F J van Heijst, Boris Kramer, Anne Debeer, Inge A Zonnenberg, Yoann Marechal, Henry Blom 15, Katleen Plaskie, Maruschka P Merkus, Martin Offringa, Anton H van Kaam; SToP-BPD Study Group; STOP-BPD Study Group
PMID: 35534184 Abstract Objective: Observational studies in preterm infants suggest that systemic hydrocortisone improves pulmonary condition but may also lead to systemic adverse effects. We report the short-term pulmonary and systemic effects of hydrocortisone initiated in the second week. Design: Randomised placebo-controlled trial. Setting: Dutch and Belgian neonatal intensive care units. Patients: Infants born 30 weeks' gestation and/or birth weight 1250 g, and ventilator dependent in the second week of life.
Intervention: Infants were randomly assigned to a 22-day course of systemic hydrocortisone (cumulative dose 72.5 mg/kg; n=182) or placebo (n=190).
Main outcome measures: Data on extubation, ventilator settings, glucose levels, and blood pressure were recorded daily and analysed during the first 7 days of treatment using linear mixed-effects models.
Results: Infants in the hydrocortisone group (24.3%) failed extubation less often compared with placebo (38.6%, crude risk difference: -14.3% (95% CI: -23.4% to -4.8%)). The estimated difference in daily rate of change between hydrocortisone and placebo was -0.42 cmH2O (95% CI: -0.48 to -0.36) for mean airway pressure, -0.02 (95% CI: -0.02 to -0.01) for fraction of inspired oxygen, -0.37 (95% CI: -0.44 to -0.30) for respiratory index, 0.14 mmol/L (95% CI: 0.08 to 0.21) for blood glucose levels and 0.83 mm Hg (95% CI: 0.58 to 1.09) for mean blood pressure. Conclusions: Systemic hydrocortisone initiated between 7 and 14 days after birth in ventilated preterm infants improves pulmonary condition, thereby facilitating weaning and extubation from invasive ventilation. The effects of hydrocortisone on blood glucose levels and blood pressure were mild and of limited clinical relevance.
Hum Reprod. 2023 Jan 5;38(1):156-167. Impact of female obesity and assisted reproduction on uncomplicated pregnancies and healthy births: a study of 428 336 births in Flanders
F Wuytack, R Devlieger, L Ameye, P Corcoran, A P Fitzgerald, W Ombelet, A Bogaerts
PMID: 36256863 Abstract Study question: What is the impact of BMI on uncomplicated pregnancies and healthy births in women who did or did not have medically assisted reproduction (MAR, i.e. ART or hormonal stimulation without manipulation of eggs or embryos) in the Flanders region (Belgium)? Summary answer: Women with a higher BMI who use MAR are at the highest risk of pregnancy and birth complications. What we know already: Medically assisted reproduction (MAR) is used increasingly worldwide and is associated with increased risk of adverse perinatal outcomes. Obesity is also increasing globally and obese women are more likely to seek MAR since obesity is associated with infertility. When obese women undergo MAR, the risk of adverse outcomes may be enhanced but it is not clear to what extent.
Study design, size, duration: We conducted a registry-based study using the data from the Study Centre for Perinatal epidemiology database for years 2009-2015, region of Flanders, Belgium. This included 428 336 women. Participants/materials, setting, methods: The average age was 30.0 years (SD 4.78), 194 061 (45.31%) were nulliparous, and 6.3% (n = 26 971) conceived with MAR. We examined the association of BMI and MAR with the following composite primary outcomes: 'uncomplicated pregnancy and birth' and 'healthy baby'. We conducted Poisson regression and adjusted for maternal age, parity, gestational weight gain, smoking and previous caesarean section. Main results and the role of chance: In our study, 36.80% (n = 157 623) of women had an uncomplicated pregnancy and birth according to the definition used. The predicted probability of having an uncomplicated pregnancy and birth for women with a BMI of 25 kg/m2 who conceived spontaneously was 0.33 (0.32 to 0.35), while it was 0.28 (0.24 to 0.32) for women who used hormonal stimulation and 0.26 (0.22 to 0.29) for women who used IVF/ICSI. This probability reduced with increasing BMI category for both MAR and non-MAR users. For women with a BMI of 30 kg/m2, the predicted probability of having an uncomplicated pregnancy and birth was 0.28 (0.26 to 0.30) for women who conceived spontaneously, and 0.22 (0.16 to 0.29) and 0.20 (0.14 to 0.26) for women who used hormonal stimulation only or IVF/ICSI, respectively. The predicted probability of having a healthy baby for women with a BMI of 25 kg/m2 who conceived spontaneously was 0.92 (0.91 to 0.93), 0.89 (0.87 to 0.92) for women who used hormonal stimulation only and 0.85 (0.84 to 0.87) for women who used IVF/ICSI. Limitations, reasons for caution: The database did not include data on socio-economic status, pre-pregnancy morbidities and paternal BMI. Subsequently, we could not adjust for these factors in the analysis.
Wider implications of the findings: Obese women who use MAR are at the highest risk of pregnancy and birth complications. This increase in interventions also has cost and resource implications which is relevant for funding policies. Weight loss interventions prior to MAR seem plausible but their (cost-) effectiveness needs urgent investigation.
Pain Pract. 2024 Jan;24(1):160-176. 3. Pain originating from the lumbar facet joints
Sandra A S Van den Heuvel, Steven P C Cohen, Javier de Andrès Ares, Koen Van Boxem, Jan Willem Kallewaard, Jan Van Zundert
PMID: 37640913 Abstract Introduction: Pain originating from the lumbar facets can be defined as pain that arises from the innervated structures comprising the joint: the subchondral bone, synovium, synovial folds, and joint capsule. Reported prevalence rates range from 4.8% to over 50% among patients with mechanical low back pain, with diagnosis heavily dependent on the criteria employed. In well-designed studies, the prevalence is generally between 10% and 20%, increasing with age.
Methods: The literature on the diagnosis and treatment of lumbar facet joint pain was retrieved and summarized. Results: There are no pathognomic signs or symptoms of pain originating from the lumbar facet joints. The most common reported symptom is uni- or bilateral (in more advanced cases) axial low back pain, which often radiates into the upper legs in a non-dermatomal distribution. Most patients report an aching type of pain exacerbated by activity, sometimes with morning stiffness. The diagnostic value of abnormal radiologic findings is poor owing to the low specificity. SPECT can accurately identify joint inflammation and has a predictive value for diagnostic lumbar facet injections. After "red flags" are ruled out, conservatives should be considered. In those unresponsive to conservative therapy with symptoms and physical examination suggesting lumbar facet joint pain, a diagnostic/prognostic medial branch block can be performed which remains the most reliable way to select patients for radiofrequency ablation. Conclusions: Well-selected individuals with chronic low back originating from the facet joints may benefit from lumbar medial branch radiofrequency ablation.
Ann Surg Oncol. 2024 Jan;31(1):567-576. 2022 Peritoneal Surface Oncology Group International Consensus on HIPEC Regimens for Peritoneal Malignancies: Colorectal Cancer
Martin Hübner, Kurt van Der Speeten, Kim Govaerts, Ignace de Hingh, Laurent Villeneuve, Shigeki Kusamura, Olivier Glehen
PMID: 37940803 Abstract Background: Selected patients with peritoneal metastases of colorectal cancer (PM-CRC) can benefit from potentially curative cytoreductive surgery (CRS) ± hyperthermic intraperitoneal chemotherapy (HIPEC), with a median overall survival (OS) of more than 40 months. Objective: The aims of this evidence-based consensus were to define the indications for HIPEC, to select the preferred HIPEC regimens, and to define research priorities regarding the use of HIPEC for PM-CRC.
Methods: The consensus steering committee elaborated and formulated pertinent clinical questions according to the PICO (patient, intervention, comparator, outcome) method and assessed the evidence according to the Grading of Recommendation, Assessment, Development, and Evaluation (GRADE) framework. Standardized evidence tables were presented to an international expert panel to reach a consensus (4-point, weak and strong positive/negative) on HIPEC regimens and research priorities through a two-round Delphi process. The consensus was defined as ≥ 50% agreement for the 4-point consensus grading or ≥ 70% for either of the two combinations. Results: Evidence was weak or very weak for 9/10 clinical questions. In total, 70/90 eligible panelists replied to both Delphi rounds (78%), with a consensus for 10/10 questions on HIPEC regimens. There was strong negative consensus concerning the short duration, high-dose oxaliplatin (OX) protocol (55.7%), and a weak positive vote (53.8-64.3%) in favor of mitomycin-C (MMC)-based HIPEC (preferred choice: Dutch protocol: 35 mg/m2, 90 min, three fractions), both for primary cytoreduction and recurrence. Determining the role of HIPEC after CRS was considered the most important research question, regarded as essential by 85.7% of the panelists. Furthermore, over 90% of experts suggest performing HIPEC after primary and secondary CRS for recurrence > 1 year after the index surgery. Conclusions: Based on the available evidence, despite the negative results of PRODIGE 7, HIPEC could be conditionally recommended to patients with PM-CRC after CRS. While more preclinical and clinical data are eagerly awaited to harmonize the procedure further, the MMC-based Dutch protocol remains the preferred regimen after primary and secondary CRS.
Eur J Pain. 2023 Jan;27(1):176-177. Conflicting recommendations: A labyrinth for the clinician and patients: A comment to Eisenberg's et al. "medical cannabis for chronic pain" Koen Van Boxem, Antal van der Gaag, Monique Steegers, Jan Willem Kallewaard, Andre Wolff, Kris Vissers, Jan Van Zundert
PMID: 36317603
Clin Kidney J. 2023 Jan 16;16(4):603-610. Pseudo-AKI associated with targeted anti-cancer agents-the truth is in the eye of the filtration marker
Thomas Vanhoutte, Ben Sprangers
PMID: 37007700 Abstract
Besides true acute kidney injury (AKI), the occurrence of pseudo-AKI has been associated with several targeted agents. To improve the management of cancer patients treated with targeted agents, we need to be aware of this and use diagnostic approaches to differentiate between pseudo-AKI and AKI. In an article by Wijtvliet et al. in this issue of CKJ, tepotinib is added to the list of targeted agents associated with pseudo-AKI. In this editorial we discuss the current literature regarding pseudo-AKI and true AKI associated with targeted agents, and subsequently propose a management strategy to monitor kidney function in patients treated with targeted agents.
Gynecol Oncol. 2024 Jan:180:70-78. Practice patterns, time trends and quality of care of uterine cancer in Belgium: An analysis of the EFFECT database
Joren Vanbraband, Nancy Van Damme, Geert Silversmit, Anke De Geyndt, Gauthier Bouche, Gerd Jacomen, Eric de Jonge, Frédéric Goffin, Hannelore Denys, Frédéric Amant
PMID: 38086166 Abstract Objectives: To investigate the practice patterns and quality of care for uterine cancer on a national level in Belgium, including trends in practice over the period 2012-2016.
Methods: Quality indicators were measured using the EFFectiveness of Endometrial Cancer Treatment (EFFECT) database. Multivariable logistic mixed regression was used to test for associations between the quality indicators and year of diagnosis, adjusted for potential confounders and intra-cluster correlations. Results: The EFFECT database includes 4178 patients diagnosed with uterine cancer in the period 2012-2016. Minimally invasive surgery (laparoscopic or robotic-assisted) was applied in 61.6% of patients who had surgery for clinical stage I endometrial carcinoma (EC), increasing from 52.9% in 2012 to 66.4% in 2016. At least pelvic lymph node staging was performed in 69.0% of patients with clinical stage I, high-grade EC; and in 63.9% of patients with clinical stage I-II serous carcinoma, clear cell carcinoma or carcinosarcoma. The latter increased from 48.8% in 2012 to 77.2% in 2016. Adjuvant radiotherapy (external beam and/or brachytherapy) was offered to 33.5% of patients who had surgery without lymph node staging for pathological stage I EC at high-intermediate or high risk of recurrence. Adjuvant chemotherapy was administered to 64.4% of patients with pathological stage III-IVA EC. Conclusions: Study results indicate an overall good quality of care for patients with uterine cancer in Belgium. Treatment areas with potential room for improvement include the use of minimally invasive surgery, comprehensive surgical staging and adjuvant therapy, which confirms the remaining controversies in uterine cancer treatment and the need for further research.
Clin Biomech (Bristol, Avon). 2023 Jan:101:105858. The biomechanical fingerprint of hip and knee osteoarthritis patients during activities of daily living
Sam Van Rossom, Jill Emmerzaal, Rob van der Straaten, Mariska Wesseling, Kristoff Corten, Johan Bellemans, Jan Truijen, Jan Malcorps, Annick Timmermans, Benedicte Vanwanseele, Ilse Jonkers
PMID: 36525720 Abstract Background: Osteoarthritis is a highly prevalent disease affecting the hip and knee joint and is characterized by load-mediated pain and decreased quality of life. Dependent on involved joint, patients present antalgic movement compensations, aiming to decrease loading on the involved joint. However, the associated alterations in mechanical loading of the ipsi- and contra-lateral lower limb joints, are less documented. Here, we documented the biomechanical fingerprint of end-stage hip and knee osteoarthritis patients in terms of ipsilateral and contralateral hip and knee loading during walking and stair ambulation. Methods: Three-dimensional motion-analysis was performed in 20 hip, 18 knee osteoarthritis patients and 12 controls during level walking and stair ambulation. Joint contact forces were calculated using a standard musculoskeletal modelling workflow in Opensim. Involved and contralateral hip and knee joint loading was compared against healthy controls using independent t-tests (p 0.05). Findings: Both hip and knee cohorts significantly decreased loading of the involved joint during gait and stair ambulation. Hip osteoarthritis patients presented no signs of ipsilateral knee nor contralateral leg overloading, during walking and stair ascending. However, knee osteoarthritis patients significantly increased loading at the ipsilateral hip, and contralateral hip and knee joints during stair ambulation compared to controls. Interpretation: The biomechanical fingerprint in knee and hip osteoarthritis patients confirmed antalgic movement strategies to unload the involved leg during gait. Only during stair ambulation in knee osteoarthritis patients, movement adaptations were confirmed that induced unbalanced intra- and inter-limb loading conditions, which are known risk factors for secondary osteoarthritis.
Clin Appl Thromb Hemost. 2023 Jan-Dec:29:10760296231190376. Safety and Hemostatic Effectiveness of SURGICEL® Powder in Mild and Moderate Intraoperative Bleeding
Nawwar Al-Attar, Eric de Jonge, Richard Kocharian, Bogdan Ilie, Ellie Barnett, Frederik Berrevoet
PMID: 37501509 Abstract
This postmarket clinical study evaluated the safety and effectiveness of the novel adjunctive topical hemostat SURGICEL® Powder (SURGICEL®-P), a powdered form of oxidized regenerated cellulose. In a prospective, open-label, single-arm multicenter trial, adult surgical subjects with mild-to-moderate bleeding for which conventional hemostatic methods were impractical/ineffective were treated with SURGICEL®-P. Descriptive analyses included hemostatic success rate at 3, 5, and 10 min, rebleeding and thromboembolic events, SURGICEL®-P-related serious adverse events requiring surgical intervention, and SURGICEL®-P ease of use (questionnaire). In 8 centers, 103 subjects were enrolled with a median (range) age of 64.0 (33.0-88.0) years. Surgeries were open (53.4%) or laparoscopic/thoracoscopic (46.6%) and mostly urological (37.9%) and abdominal (32.0%) procedures. Bleeding sites included various tissue types, with a median (range) surface area of 4 (0.02-72.0) cm2. Hemostatic success rates were 77.7%, 87.4%, and 92.2% at 3, 5, and 10 min, respectively. In 7 subjects (6.8%), investigators reverted to standard of care. No safety signals were identified. Two deaths occurred with causes unrelated to SURGICEL®-P. Investigators favorably evaluated the ease of use of the SURGICEL®-P device. SURGICEL®-P is safe and effective in controlling mild-to-moderate bleeding in a broad range of surgical procedures.
JAMA Oncol. 2023 Feb 1;9(2):225-233. External Validation of the Ovarian-Adnexal Reporting and Data System (O-RADS) Lexicon and the International Ovarian Tumor Analysis 2-Step Strategy to Stratify Ovarian Tumors Into O-RADS Risk Groups
Stefan Timmerman, Lil Valentin, Jolien Ceusters, Antonia C Testa, Chiara Landolfo, Povilas Sladkevicius, Caroline Van Holsbeke, Ekaterini Domali, Robert Fruscio, Elisabeth Epstein, Dorella Franchi, Marek J Kudla, Valentina Chiappa, Juan L Alcazar, Francesco P G Leone, Francesca Buonomo, Maria Elisabetta Coccia, Stefano Guerriero, Nandita Deo, Ligita Jokubkiene, Jeroen Kaijser, Giovanni Scambia, Rochelle Andreotti, Dirk Timmerman, Tom Bourne, Ben Van Calster, Wouter Froyman
PMID: 36520422 Abstract Importance: Correct diagnosis of ovarian cancer results in better prognosis. Adnexal lesions can be stratified into the Ovarian-Adnexal Reporting and Data System (O-RADS) risk of malignancy categories with either the O-RADS lexicon, proposed by the American College of Radiology, or the International Ovarian Tumor Analysis (IOTA) 2-step strategy. Objective: To investigate the diagnostic performance of the O-RADS lexicon and the IOTA 2-step strategy.
Design, setting, and participants: Retrospective external diagnostic validation study based on interim data of IOTA5, a prospective international multicenter cohort study, in 36 oncology referral centers or other types of centers. A total of 8519 consecutive adult patients presenting with an adnexal mass between January 1, 2012, and March 1, 2015, and treated either with surgery or conservatively were included in this diagnostic study. Twenty-five patients were excluded for withdrawal of consent, 2777 were excluded from 19 centers that did not meet predefined data quality criteria, and 812 were excluded because they were already in follow-up at recruitment. The analysis included 4905 patients with a newly detected adnexal mass in 17 centers that met predefined data quality criteria. Data were analyzed from January 31 to March 1, 2022. Exposures: Stratification into O-RADS categories (malignancy risk 1%, 1% to 10%, 10% to 50%, and ≥50%). For the IOTA 2-step strategy, the stratification is based on the individual risk of malignancy calculated with the IOTA 2-step strategy.
Main outcomes and measures: Observed prevalence of malignancy in each O-RADS risk category, as well as sensitivity and specificity. The reference standard was the status of the tumor at inclusion, determined by histology or clinical and ultrasonographic follow-up for 1 year. Multiple imputation was used for uncertain outcomes owing to inconclusive follow-up information. Results: Median age of the 4905 patients was 48 years (IQR, 36-62 years). Data on race and ethnicity were not collected. A total of 3441 tumors (70%) were benign, 978 (20%) were malignant, and 486 (10%) had uncertain classification. Using the O-RADS lexicon resulted in 1.1% (24 of 2196) observed prevalence of malignancy in O-RADS 2, 4% (34 of 857) in O-RADS 3, 27% (246 of 904) in O-RADS 4, and 78% (732 of 939) in O-RADS 5; the corresponding results for the IOTA 2-step strategy were 0.9% (18 of 1984), 4% (58 of 1304), 30% (206 of 690), and 82% (756 of 927). At the 10% risk threshold (O-RADS 4-5), the O-RADS lexicon had 92% sensitivity (95% CI, 87%-96%) and 80% specificity (95% CI, 74%-85%), and the IOTA 2-step strategy had 91% sensitivity (95% CI, 84%-95%) and 85% specificity (95% CI, 80%-88%). Conclusions and relevance: The findings of this external diagnostic validation study suggest that both the O-RADS lexicon and the IOTA 2-step strategy can be used to stratify patients into risk groups. However, the observed malignancy rate in O-RADS 2 was not clearly below 1%.
Am J Cardiol. 2023 Feb 1:188:30-35. Validation of the OPEN-CLEAN Chronic Total Occlusion Percutaneous Coronary Intervention Perforation Score in a Multicenter Registry
Bahadir Simsek, Mauro Carlino, Soledad Ojeda, Manuel Pan, Stephane Rinfret, Evangelia Vemmou, Spyridon Kostantinis, Ilias Nikolakopoulos, Judit Karacsonyi, Alexandre S Quadros, Joseph A Dens, Nidal Abi Rafeh, Pierfrancesco Agostoni, Khaldoon Alaswad, Alexandre Avran, Karlyse C Belli, James W Choi, Ahmed Elguindy, Farouc A Jaffer, Darshan Doshi, Dimitri Karmpaliotis, Jaikirshan J Khatri, Dmitrii Khelimskii, Paul Knaapen, Alessio La Manna, Oleg Krestyaninov, Pablo Lamelas, Lucio Padilla, Pedro Piccaro de Oliveira, James C Spratt, Masaki Tanabe, Simon Walsh, Omer Goktekin, Sevket Gorgulu, Olga C Mastrodemos, Salman Allana, Bavana V Rangan, Kathleen E Kearney, William L Lombardi, J Aaron Grantham, Taishi Hirai, Emmanouil S Brilakis, Lorenzo Azzalini
PMID: 36462272 Abstract
Coronary artery perforation is one of the most common and feared complications of chronic total occlusion (CTO) percutaneous coronary intervention (PCI). We evaluated the utility of the recently presented OPEN-CLEAN (Coronary artery bypass graft, Length of occlusion, Ejection fraction, Age, calcificatioN) perforation score in an independent multicenter CTO PCI dataset. Of the 2,270 patients who underwent CTO PCI at 7 centers, 150 (6.6%) suffered coronary artery perforation. Patients with perforations were older (69 ± 10 vs 65 ± 10, p 0.001), more likely to be women (89% vs 82%, p = 0.010), more likely to have history of previous coronary artery bypass graft (38% vs 20%, p 0.001), and unfavorable angiographic characteristics such as blunt stump (64% vs 42%, p 0.001), proximal cap ambiguity (51% vs 33%, p 0.001), and moderate-severe calcification (57% vs 43%, p = 0.001). Technical success was lower in patients with perforations (69% vs 85%, p 0.001). The area under the receiver operating characteristic curve of the OPEN-CLEAN perforation risk model was 0.74 (95% confidence interval 0.68 to 0.79), with good calibration (Hosmer-Lemeshow p = 0.72). We found that the CTO PCI perforation risk increased with higher OPEN-CLEAN scores: 3.5% (score 0 to 1), 3.1% (score 2), 5.3% (score 3), 7.1% (score 4), 11.5% (score 5), 19.8% (score 6 to 7). In conclusion, given its good performance and ease of preprocedural calculation, the OPEN-CLEAN perforation score appears to be useful for quantifying the perforation risk for patients who underwent CTO PCI.
Pain Pract. 2024 Feb;24(2):308-320. 4. Painful diabetic polyneuropathy
Xander Zuidema, Bastiaan de Galan, Brigitte Brouwer, Steven P Cohen, Sam Eldabe, Charles E Argoff, Frank Huygen, Jan Van Zundert
PMID: 37859565 Abstract Introduction: Pain as a symptom of diabetic polyneuropathy (DPN) significantly lowers quality of life, increases mortality and is the main reason for patients with diabetes to seek medical attention. The number of people suffering from painful diabetic polyneuropathy (PDPN) has increased significantly over the past decades. Methods: The literature on the diagnosis and treatment of diabetic polyneuropathy was retrieved and summarized. Results: The etiology of PDPN is complex, with primary damage to peripheral nociceptors and altered spinal and supra-spinal modulation. To achieve better patient outcomes, the mode of diagnosis and treatment of PDPN evolves toward more precise pain-phenotyping and genotyping based on patient-specific characteristics, new diagnostic tools, and prior response to pharmacological treatments. According to the Toronto Diabetic Neuropathy Expert Group, a presumptive diagnosis of "probable PDPN" is sufficient to initiate treatment. Proper control of plasma glucose levels, and prevention of risk factors are essential in the treatment of PDPN. Mechanism-based pharmacological treatment should be initiated as early as possible. If symptomatic pharmacologic treatment fails, spinal cord stimulation (SCS) should be considered. In isolated cases, where symptomatic pharmacologic treatment and SCS are unsuccessful or cannot be used, sympathetic lumbar chain neurolysis and/or radiofrequency ablation (SLCN/SLCRF), dorsal root ganglion stimulation (DRGs) or posterior tibial nerve stimulation (PTNS) may be considered. However, it is recommended that these treatments be applied only in a study setting in a center of expertise. Conclusions: The diagnosis of PDPN evolves toward pheno-and genotyping and treatment should be mechanism-based.
Arch Dis Child Fetal Neonatal Ed. 2024 Feb 19;109(2):159-165. Identifying effect modifiers of systemic hydrocortisone treatment initiated 7-14 days after birth in ventilated very preterm infants on long-term outcome: secondary analysis of a randomised controlled trial
Nienke Marjolein Halbmeijer, Michel Sonnaert, Renate M Swarte, Corine Koopman-Esseboom, Margriet van Stuijvenberg, Susanne Mulder-de Tollenaer, Ratna N G B Tan, Thilo Mohns, Els Bruneel, Katerina Steiner, Boris W Kramer, Anne Debeer, Mirjam M van Weissenbruch, Yoann Marechal, Henry Blom, Katleen Plaskie, Martin Offringa, Maruschka P Merkus, Wes Onland, Aleid G Leemhuis, Anton H van Kaam; SToP-BPD Study group
PMID: 37722765 Abstract Objective: To explore clinical effect modifiers of systemic hydrocortisone in ventilated very preterm infants for survival and neurodevelopmental outcome at 2 years' corrected age (CA). Design: Secondary analysis of a randomised placebo-controlled trial.
Setting: Dutch and Belgian neonatal intensive care units. Patients: Infants born 30 weeks' gestational age (GA), ventilator-dependent in the second week of postnatal life. Intervention: Infants were randomly assigned to systemic hydrocortisone (cumulative dose 72.5 mg/kg; n=182) or placebo (n=190).
Main outcome measures: The composite of death or neurodevelopmental impairment (NDI) at 2 years' CA and its components. Candidate effect modifiers (GA, small for GA, respiratory index, sex, multiple births, risk of moderate/severe bronchopulmonary dysplasia or death) were analysed using regression models with interaction terms and subpopulation treatment effect pattern plots.
Results: The composite outcome was available in 356 (96.0%) of 371 patients (one consent withdrawn). For this outcome, treatment effect heterogeneity was seen across GA subgroups (27 weeks: hydrocortisone (n=141) vs placebo (n=156), 54.6% vs 66.2%; OR 0.61 (95% CI 0.38 to 0.98); ≥27 weeks: hydrocortisone (n=30) vs placebo (n=31), 66.7% vs 45.2%; OR 2.43 (95% CI 0.86 to 6.85); p=0.02 for interaction). This effect was also found for the component death (27 weeks: 20.1% vs 32.1%; OR 0.53 (95% CI 0.32 to 0.90); ≥27 weeks: 28.1% vs 16.1%; OR 2.04 (95% CI 0.60 to 6.95); p=0.049 for interaction) but not for the component NDI. No differential treatment effects were observed across other subgroups. Conclusion: This secondary analysis suggests that in infants 27 weeks' GA, systemic hydrocortisone may improve the outcome death or NDI, mainly driven by its component death. There was insufficient evidence for other selected candidate effect modifiers.
Clin Nutr ESPEN. 2024 Feb:59:162-170. The impact of high versus standard enteral protein provision on functional recovery following intensive care admission: Protocol for a pre-planned secondary Bayesian analysis of the PRECISe trial
Samuel Heuts, Pieter de Heer, Andrea Gabrio, Julia L M Bels, Zheng-Yii Lee, Christian Stoppe, Sander van Kuijk, Albertus Beishuizen, Ashley de Bie-Dekker, Vincent Fraipont, Stoffel Lamote, Didier Ledoux, Clarissa Scheeren, Elisabeth De Waele, Arthur van Zanten, Dieter Mesotten, Marcel C G van de Poll; PRECISe investigators
PMID: 38220371 Abstract Background: The PRECISe trial is a pragmatic, multicenter randomized controlled trial that evaluates the effect of high versus standard enteral protein provision on functional recovery in adult, mechanically ventilated critically ill patients. The current protocol presents the rationale and analysis plan for an evaluation of the primary and secondary outcomes under the Bayesian framework, with an emphasis on clinically important effect sizes. Methods: This protocol was drafted in agreement with the ROBUST-statement, and is submitted for publication before database lock and primary data analysis. The primary outcome is health-related quality of life as measured by the EQ-5D-5L health utility score and is longitudinally assessed. Secondary outcomes comprise the 6-min walking test and handgrip strength over the entire follow-up period (longitudinal analyses), and 60-day mortality, duration of mechanical ventilation, and EQ-5D-5L health utility scores at 30, 90 and 180 days (cross-sectional). All analyses will primarily be performed under weakly informative priors. When available, informative priors elicited from contemporary literature will also be incorporated under alternative scenarios. In all other cases, objectively formulated skeptical and enthusiastic priors will be defined to assess the robustness of our results. Relevant identified subgroups were: patients with acute kidney injury, severe multi-organ failure and patients with or without sepsis. Results will be presented as absolute risk differences, mean differences, and odds ratios, with accompanying 95% credible intervals. Posterior probabilities will be estimated for clinically important benefit and harm. Discussion: The proposed secondary, pre-planned Bayesian analysis of the PRECISe trial will provide additional information on the effects of high protein on functional and clinical outcomes in critically ill patients, such as probabilistic interpretation, probabilities of clinically important effect sizes, and the integration of prior evidence. As such, it will complement the interpretation of the primary outcome as well as several secondary and subgroup analyses.
J Robot Surg. 2023 Feb;17(1):55-62. Robotic biliary surgery for benign and malignant bile duct obstruction: a case series Mathieu D'Hondt, Dennis A Wicherts
PMID: 35312931 Abstract
The majority of patients with benign or malignant biliary obstruction require surgical treatment with a bilio-enteric anastomosis. This requires fine dissection and advanced suturing. Robotic surgery may overcome some major limitations of conventional laparoscopic surgery. The precise role of robotic biliary surgery is, however, still to be defined. In our institution, patients requiring complex bile duct surgery were consecutively selected for minimally invasive robotic surgery from September 2020. All surgeries were undertaken using the da Vinci Xi Surgical System® (Intuitive Surgical, Sunnyvale, CA, USA). Intra-operative technique and postoperative outcome were analyzed. A total number of 14 patients underwent robotic biliary surgery for a variety of benign and malignant indications between September 2020 and May 2021. Six of fourteen patients (43%) had previous open abdominal surgery. Median blood loss was 25 mL (range 10-120 mL). There were no intra-operative complications and no conversions. Length of stay was between 3 and 11 days without major postoperative morbidity. Robotic surgery for benign and malignant bile duct obstruction is efficient and safe in experienced hands. Referral to a high-volume expert center is, however, advised.
J Arthroplasty. 2023 Feb;38(2):314-322.e1. The Safety and Efficacy of the Anterior Approach Total Hip Arthroplasty as per Body Mass Index
Jeroen C F Verhaegen, Roger Wei, Paul Kim, Paul E Beaulé, Kristoff Corten, George Grammatopoulos
PMID: 35987493 Abstract Background: Obesity is associated with component malpositioning and increased revision risk after total hip arthroplasty (THA). With anterior approaches (AAs) becoming increasingly popular, the goal of this study was to assess whether clinical outcome post-AA-THA is affected by body mass index (BMI). Methods: This multicenter, multisurgeon, consecutive case series used a prospective database of 1,784 AA-THAs (1,597 patients) through bikini (n = 1,172) or standard (n = 612) incisions. Mean age was 63 years (range, 20-94 years) and there were 57.5% women, who had a mean follow-up of 2.7 years (range, 2.0-4.1 years). Patients were classified into the following BMI groups: normal (BMI 25.0; n = 572); overweight (BMI: 25.0-29.9; n = 739); obese (BMI: 30.0-34.9; n = 330); and severely obese (BMI ≥ 35.0; n = 143). Outcomes evaluated included hip reconstruction (inclination/anteversion and leg-length, complications, and revision rates) and patient-reported outcomes including Oxford Hip Scores (OHS). Results: Mean postoperative leg-length difference was 2.0 mm (range: -17.5 to 39.0) with a mean cup inclination of 34.8° (range, 14.0-58.0°) and anteversion of 20.3° (range, 8.0-38.6°). Radiographic measurements were similar between BMI groups (P = .1-.7). Complication and revision rates were 2.5% and 1.7%, respectively. The most common complications were fracture (0.7%), periprosthetic joint infection (PJI) (0.5%), and dislocation (0.5%). There was no difference in dislocation (P = .885) or fracture rates (P = .588) between BMI groups. There was a higher rate of wound complications (1.8%; P = .053) and PJIs (2.1%; P = .029) among obese and severely obese patients. Wound complications were less common among obese patients with the 'bikini' incision (odds ratio 2.7). Preoperative OHS was worse among the severely obese (P .001), which showed similar improvements (Change in OHS; P = .144). Conclusion: AA-THA is a credible option for obese patients, with low dislocation or fracture risk and excellent ability to reconstruct the hip, leading to comparable functional improvements among BMI groups. Obese patients have a higher risk of PJIs. Bikini incision for AA-THA can help minimize the risk of wound complications.
Hypertension. 2023 Feb;80(2):343-351. First-Trimester Normotension Is a Weak Indicator of Normal Maternal Cardiovascular Function Wilfried Gyselaers, Pauline Dreesen, Anneleen Simone Staelens, Kathleen Tomsin, Liesbeth Bruckers, Sharona Vonck
PMID: 36148652 Abstract Background: As by definition, mean arterial pressure equals the product of cardiac output (CO) and total vascular resistance (TPR), we hypothesized that, irrespective of thresholds to define hypertension, a CO-TPR imbalance might exist in first-trimester normotensive pregnancies with altered risks for adverse gestational outcomes. Methods: A standard protocol was used for automated blood pressure measurement combined with impedance cardiography assessment of CO and TPR (NICCOMO). First-trimester normotensive pregnant women were categorized into 3 groups relative to the reference 75th percentile (P75) of CO and TPR: (1) normal CO and TPR, (2) high CO, and (3) high TPR. These subgroups were compared at blood pressure thresholds 140/90, 130/85, and 130/80 mmHg. The gestational outcome was categorized after birth according to International Society for Studies of Hypertension in Pregnancy criteria.
Results: Compared with pregnancies with normal CO and TPR (≤P75), women with high TPR at blood pressure 140/90 mmHg are at risk for developing gestational hypertension (odds ratio, 3.795 [1.321-10.904]; P0.010), late-onset preeclampsia (odds ratio, 3.137 [1.060-9.287]; P0.050), and neonates small for gestational age (odds ratio, 1.780 [1.056-2.998]; P0.050). Conclusions: Cardiovascular imbalance can present in normotensive women in the first trimester and is associated with increased risks for adverse gestational outcomes. This study illustrates the relevance of CO and TPR assessments as an adjunct to blood pressure measurement and invites for further exploring their value in screening algorithms for gestational hypertensive disorders and/or small for gestational age.
Clin Kidney J. 2023 Feb 28;16(5):773-775. Revisiting the role of acute kidney injury in patients on immune checkpoint inhibitors: a good prognosis renal event with a significant impact on survival
Clara García-Carro, Kenar D Jhaveri, Ben Sprangers
PMID: 37151419 Abstract
In the last decade, immune checkpoint inhibitors (ICI) have become a cornerstone in the treatment of a wide range of malignancies. It is well established that ICI are associated with multiple immune-related adverse events, a spectrum of autoimmune toxicities, that can also affect the kidney. In this issue of Clinical Kidney Journal, Kanbay et al. report the first meta-analysis and systematic review evaluating the impact of ICI-related acute kidney injury (ICI-AKI) on long-term kidney and patient outcomes (including mortality). The authors report a high incidence of ICI-AKI (mostly mild AKI episodes) with high rates of recovery resulting in a good kidney outcomes. However, the occurrence of ICI-AKI has a significant impact on mortality in ICI-treated patients probably related to temporary or definitive cessation of ICI. Additional studies are needed to establish the safety of ICI re-challenging in patients with ICI-AKI, and to determine the optimal treatment strategy for them.
J Robot Surg. 2023 Feb;17(1):79-88. Transition from laparoscopic to robotic liver surgery: clinical outcomes, learning curve effect, and cost-effectiveness
M D'Hondt, A Devooght, E Willems, D Wicherts, C De Meyere, I Parmentier, A Provoost, H Pottel, C Verslype
PMID: 35322342 Abstract
The reproducibility of the implementation of robotic liver surgery (RLS) is still debated. The aim of the present study is to evaluate short-term outcomes and cost differences during the implementation of RLS, performed by an early adopter in laparoscopic liver surgery (LLS). Patients undergoing RLS between February 2020 and May 2021 were included. Short-term outcomes of the robotic group (RG) were compared to the "Initial Phase" group (IP) of 120 LLS cases and the 120 most recent laparoscopic cases or "Mastery Phase" group (MP). A cost analysis per procedure for the three groups was performed. Seventy-one patients underwent RLS during the study period. Median operative time in the RG was comparable to the IP, but significantly shorter in the MP (140 vs 138 vs 120 min, p 0.001). Median intraoperative blood loss in the RG was lower than in both laparoscopic groups (40 ml [20-90 ml] vs 150 ml [50-250 ml] vs 80 ml [30-150 ml], p 0.001). Median hospital stay in the RG was significantly shorter than the IP group (p 0.001). There were no significant differences in postoperative complication, conversion, or readmission rates. Procedural cost analysis was in favor of robotic surgery (€5008) compared to the IP (€ 6913) and the MP (€6099). Surgeons with sufficient experience in LLS can rapidly overcome the learning curve for RLS. In our experience, the short-term outcomes of the implementation phase of RLS are similar to the mastery phase of LLS. The total average cost per procedure is lower for RLS compared to LLS.
Curr Heart Fail Rep. 2023 Feb;20(1):88-100. Spot Urinary Sodium Measurements: the Future Direction of the Treatment and Follow-up of Patients with Heart Failure
Evelyne Meekers, Wilfried Mullens
PMID: 36807114 Abstract Purpose of review: Heart failure is characterized by episodes of congestion with need for hospitalization. The current metrics lack the accuracy to predict and prevent episodes of congestion and to guide diuretic titration to reach euvolemia in case of decompensation. This article aims to provide answers to the role of urinary sodium measurements in acute and chronic heart failure. Recent findings: In acute heart failure, urinary sodium concentrations at the moment of admission and after diuretic administration are correlated with short- and long-term outcome. As this is a reflection of the degree of sodium retention, it can be used as a guide in the diuretic titration. In chronic heart failure, it might be used to predict and consequently prevent episodes of decompensation. Urinary sodium measurements hold great promises to be a novel diagnostic and therapeutic parameter in patients with acute and chronic heart failure. However, more research is needed.
J Card Fail. 2023 Feb;29(2):171-180. Rationale and Design of the Proactive-HF Trial for Managing Patients With NYHA Class III Heart Failure by Using the Combined Cordella Pulmonary Artery Sensor and the Cordella Heart Failure System
Jason L Guichard, Jennifer A Cowger, Sandra V Chaparro, Michael S Kiernan, Wilfried Mullens, Claudius Mahr, Chris Mullin, Omid Forouzan, Nicholas J Hiivala, Andrea Sauerland, Katrin Leadley, Liviu Klein
PMID: 36191758 Abstract Background: Optimizing guideline-directed medical therapy (GDMT) and monitoring congestion in patients with heart failure (HF) are key to disease management and preventing hospitalizations. A pulmonary artery pressure (PAP)-guided HF management system providing access to body weight, blood pressure, heart rate, blood oxygen saturation, PAP, and symptoms, may provide new insights into the effects of patient engagement and comprehensive care for remote GDMT titration and congestion management. Methods: The PROACTIVE-HF study was originally approved in 2018 as a prospective, randomized, controlled, single-blind, multicenter trial to evaluate the safety and effectiveness of the Cordella PAP Sensor in patients with HF and with New York Heart Association (NYHA) functional class III symptoms. Since then, robust clinical evidence supporting PAP-guided HF management has emerged, making clinical equipoise and enrolling patients into a standard-of-care control arm challenging. Therefore, PROACTIVE-HF was changed to a single-arm trial in 2021 with prespecified safety and effectiveness endpoints to provide evidence for a similar risk/benefit profile as the CardioMEMS HF System. Conclusion: The single-arm PROACTIVE-HF trial is expected to further demonstrate the benefits of PAP-guided HF management of patients with NYHA class III HF. The addition of vital signs, patient engagement and self-reported symptoms may provide new insights into remote GDMT titration and congestion management.
Catheter Cardiovasc Interv. 2024 Feb;103(2):382-388. Bleeding and thrombotic risk of different antiplatelet regimens posttranscatheter edge-to-edge mitral valve repair in patients with an indication for oral anticoagulation: Results from an all-comers national registry
Marc J Claeys, Adel Aminian, Jozef Bartunek, Johan Bennett, Ian Buysschaert, Mathias Claeys, Dina De Bock, Lies Delodder, Philippe Debonnaire, Willem Dewilde, Bert Ferdinande, Stéphanie Geerinck, Kaatje Goetschalckx, Olivier Lambrechts, Stijn Lochy, Bernard P Paelinck, Liesbeth Rosseel, Didier Stroobants, Marc Vanderheyden, Jan Van der Heyden, Peter Verbrugghe, Stefan Verheye, Christophe Dubois
PMID: 38078877 Abstract Background: Evidence-based recommendations for antithrombotic treatment in patients who have an indication for oral anticoagulation (OAC) after transcatheter edge-to-edge mitral valve repair (TEER) are lacking. Aims: To compare bleeding and thrombotic risk for different antithrombotic regimens post-TEER with MitraClip in an unselected population with the need for OACs.
Methods: Bleeding and thrombotic complications (stroke and myocardial infarction) up to 3 months after TEER with mitraclip were evaluated in 322 consecutive pts with an indication for OACs. These endpoints were defined by the Mitral Valve Academic Research Consortium criteria and were compared between two antithrombotic regimens: single antithrombotic therapy with OAC (single ATT) and double/triple ATT with a combination of OAC and aspirin and/or clopidogrel (combined ATT). Results: Collectively, 108 (34%) patients received single ATT, 203 (63%) received double ATT and 11 (3%) received triple ATT. Bleeding events occurred in 67 patients (20.9%), with access site related events being the most frequent cause (37%). Bleeding complications were observed more frequently in the combined ATT group than in the single ATT group: 24% versus 14% [p = 0.03, adjusted RR: 0.55 (0.3-0.98)]. Within the combined group, the bleeding risk was 23% in the double ATT and 45% in the triple ATT group. Thrombotic complications occurred in only three patients (0.9%), and all belonged to the combined ATT group. Conclusions: In patients with an indication for OACs, withholding of antiplatelet therapy post-TEER with Mitraclip was associated with a 45% reduction in bleeding and without a signal of increased thrombotic risk.
Acta Cardiol. 2023 Feb;78(1):86-90. A prospective, multi-center, randomised controlled trial for evaluation of the effectiveness of the Blimp scoring balloon in lesions not crossable with a conventional balloon or microcatheter: the BLIMP study J Dens, W Holvoet, K McCutcheon, C Ungureanu, P Coussement, S Haine, Q De Hemptinne, J Sonck, W Eertmans, J Bennett
PMID: 35972446 Abstract Background: Balloon uncrossable coronary lesions are lesions that cannot be crossed with a conventional balloon. Multiple balloons have been designed to overcome this problem. The Blimp balloon has a very low scoring profile (0.6 mm) with a very high rated burst pressure (30 atmospheres). We aimed to evaluate the efficacy of this balloon compared to customary low-profile balloons. Methods: We conducted a multicenter, prospective, randomised, controlled trial in which 126 patients with an uncrossable lesion were randomly (1:1 randomization) assigned to treatment first with the Blimp balloon or low-profile balloon. The primary endpoint was the success of crossing the lesion after initial failure with a microcatheter (group A) or with a conventional balloon (group B). Results: Overall, the first attempt of Blimp was successful in 29 out of 61 cases (48%) while the LP balloon immediately crossed in 30 out 67 cases (45%; p = 0.761). Using a low-profile balloon in the BLIMP group after failure of the Blimp balloon increased the success to 64% (39 out of 61 cases). Using the Blimp balloon in the low-profile first group after failure of the low-profile balloon increased the success to 60% (40 out of 67 cases). After the placement of a guide catheter extension, the overall successful lesion crossing in the BLIMP group was 80% (49 out of 61 cases) compared to 76% (51 out of 67 cases) in the LP Balloon group (p = 0.327). Conclusions: The Blimp balloon catheter showed no superiority to customary low-profile balloons in uncrossable lesions. It can however be complementary in treating uncrossable lesions.
JACC Heart Fail. 2023 Feb;11(2):243-249. Cardiopulmonary Exercise Testing With Simultaneous Echocardiography: Blueprints of a Dyspnea Clinic for Suspected HFpEF
Jan Verwerft, Philippe B Bertrand, Guido Claessen, Lieven Herbots, Frederik H Verbrugge
PMID: 36754531
No abstract available
Europace. 2021 Feb 5;25(6):euab035. Withdrawn as duplicate: Optimized Implementation of cardiac resynchronization therapy - a call for action for referral and optimization of care Wilfried Mullens, Angelo Auricchio, Pieter Martens, Klaus Witte, Martin R Cowie, Victoria Delgado, Kenneth Dickstein, Cecilia Linde, Kevin Vernooy, Francisco Leyva, Johann Bauersachs , Carsten W Israel, Lars Lund, Erwan Donal, Giuseppe Boriani, Tiny Jaarsma, Antonio Berruezo, Vassil Traykov, Zaheer Yousef, Zbigniew Kalarus, Jens Cosedis Nielsen, Jan Steffel, Panos Vardas, Andrew Coats, Petar Seferovic, Thor Edvardsen, Hein Heidbuchel, Frank Ruschitzka, Christophe Leclercq
PMID: 33544835
Eur J Heart Fail. 2024 Feb;26(2):511-520. Long-term outcome after upgrade to cardiac resynchronization therapy: A propensity score-matched analysis
Sander Trenson, Gabor Voros, Pieter Martens, Sebastian Ingelaere, Pascal Betschart, Jens-Uwe Voigt, Matthias Dupont, Alexander Breitenstein, Jan Steffel, Rik Willems, Frank Ruschitzka, Wilfried Mullens, Stephan Winnik, Bert Vandenberk
PMID: 37905357 Abstract Aim: Cardiac resynchronization therapy (CRT) is a cornerstone in the management of chronic heart failure in patients with a broad or paced QRS. However, data on long-term outcome after upgrade to CRT are scarce. Methods and results: This international, multicentre retrospective registry included 2275 patients who underwent a de novo or upgrade CRT implantation with a mean follow-up of 3.6 ± 2.7 years. The primary composite endpoint included all-cause mortality, heart transplantation, or ventricular assist device implantation. The secondary endpoint was first heart failure admission. Multivariable Cox regression and propensity score matching (PSM) analyses were performed. Patients who underwent CRT upgrade (n = 605, 26.6%) were less likely female (19.7% vs. 28.8%, p 0.001), more often had ischeemic cardiomyopathy (49.8% vs. 40.2%, p 0.001), and had worse renal function (median estimated glomerular filtration rate 50.3 ml/min/1.73 m2 [35.8-69.5] vs. 59.9 ml/min/1.73 m2 [43.0-76.5], p 0.001). The incidence rate of the composite endpoint was 10.8%/year after CRT upgrade versus 7.1%/year for de novo implantations (p 0.001). PSM for the primary endpoint resulted in 488 pairs. After propensity score matching, upgrade to CRT was associated with a higher chance to reach the composite endpoint (multivariable hazard ratio [HR] 1.35, 95% confidence interval [CI] 1.08-1.70), for both upgrade from pacemaker (multivariable HR 1.33, 95% CI 1.03-1.70) and implantable cardioverter-defibrillator (ICD) (multivariable HR 1.40, 95% CI 1.01-1.95). PSM for the secondary endpoint resulted in 277 pairs. After PSM, upgrade to CRT was associated with a higher chance for heart failure admission (HR 1.74, 95% CI 1.26-2.41). Conclusion: In this retrospective analysis, the outcome of patients who underwent upgrades to CRT differed significantly from patients who underwent de novo CRT implantation, particularly for upgrades from ICD. Importantly, this difference in outcome does not imply a causal relation between therapy and outcome but rather a difference between two different patient populations.
ESC Heart Fail. 2023 Feb;10(1):650-660. Dynamic aspects of ventricular interaction during exercise in HFpEF and in pre-capillary pulmonary hypertension
Mathias Claeys, Thibault Petit, Jan Bogaert, Andre La Gerche, Jan Los, Marion Delcroix, Rik Willems, Guido Claessen, Piet Claus
PMID: 36424844 Abstract Aims: The contribution of adverse ventricular interdependence remains undervalued in heart failure or pulmonary vascular disease, and not much is known about its dynamic nature during exercise and respiration. In this study, we evaluated ventricular interaction during exercise in patients with heart failure with preserved ejection fraction (HFpEF) and patients with chronic thromboembolic pulmonary hypertension (CTEPH) as compared with healthy controls. Methods and results: Forty-six subjects (10 controls, 19 CTEPH patients, and 17 HFpEF patients) underwent cardiac magnetic resonance imaging during exercise. Ventricular interaction was determined through analysis of the septal curvature (SC) of a mid-ventricular short-axis slice at end-diastole, end-systole, and early-diastole, both in expiration and inspiration. Exercise amplified ventricular interaction in CTEPH patients and to a lesser extent in HFpEF patients (P 0.05 for decrease in SC with exercise). Adverse interaction was most profound in early-diastole and most pronounced in CTEPH patients (P 0.05 interaction group * exercise) because of a disproportionate increase RV afterload (P 0.05 to both controls and HFpEF) and diastolic pericardial restraint (P 0.001 for interaction group * exercise) during exercise. Inspiration enhanced diastolic interdependence in CTEPH and HFpEF patients (P 0.05 vs. expiration). Both at rest and during exercise, SC strongly correlated with RV volumes and pulmonary artery pressures (all P 0.05). Conclusions: Exercise amplifies adverse right-left ventricular interactions in CTEPH, while a more moderate effect is observed in isolated post-capillary HFpEF. Given the strong link with RV function and pulmonary hemodynamic, assessing ventricular interaction with exCMR might be valuable from a diagnostic or therapeutic perspective.
Eur Cell Mater. 2023 Feb 20:45:60-71. Microstructural adaptations of the subchondral bone are related to the mechanical axis deviation in end stage varus oa knees
W Colyn, F Azari, J Bellemans, G H van Lenthe, L Scheys
PMID: 36808322 Abstract
Recent studies highlighted the crucial contribution of subchondral bone to OA development. Yet, only limited data have been reported on the relation between alteration to cartilage morphology, structural properties of the subchondral bone plate (SBP) and underlying subchondral trabecular bone (STB). Furthermore, the relationship between the morphometry of the cartilage and bone in the tibial plateau and the OA-induced changes in the joint's mechanical axis remains unexplored. Therefore, a visualisation and quantification of cartilage and subchondral bone microstructure in the medial tibial plateau was performed. End stage knee-OA patients with varus alignment and scheduled for total knee arthroplasty (TKA) underwent preoperative fulllength radiography to measure the hip-knee-ankle angle (HKA) and the mechanical-axis deviation (MAD). 18 tibial plateaux were μ-CT scanned (20.1 μm/voxel). Cartilage thickness, SBP, and STB microarchitecture were quantified in 10 volumes of interest (VOIs) in each medial tibial plateau. Significant differences (p 0.001) were found for cartilage thickness, SBP, and STB microarchitecture parameters among the VOIs. Closer to the mechanical axis, cartilage thickness was consistently smaller, while SBP thickness and STB bone volume fraction (BV/TV) were higher. Moreover, trabeculae were also more superior-inferiorly oriented, i.e. perpendicular to the transverse plane of the tibial plateau. As cartilage and subchondral bone changes reflect responses to local mechanical loading patterns in the joint, the results suggested that region-specific subchondral bone adaptations were related to the degree of varus deformity. More specifically, subchondral sclerosis appeared to be most pronounced closer to the mechanical axis of the knee.
J Clin Monit Comput. 2023 Feb;37(1):287-296. Is it feasible to measure intra-abdominal pressure using a balloon-tipped rectal catheter? Results of a validation study
Anneleen S Staelens, Ann Heymans, Sigrid Christiaens, Niels Van Regenmortel, Wilfried Gyselaers, Manu L N G Malbrain
PMID: 35907136 Abstract
The gold standard to measure intra-abdominal pressure (IAP) is intra-vesical measurement via the urinary bladder. However, this technique is restricted in ambulatory settings because of the risk of iatrogenic urinary tract infections. Rectal IAP measurements (IAPrect) may overcome these limitations, but requires validation. This validation study compares the IAPrect technique against gold standard intra-vesical IAP measurements (IAPves). IAPrect using an air-filled balloon catheter and IAPves using Foley Manometer Low Volume were measured simultaneously in sedated and ventilated patients. Measurements were performed twice in different positions (supine and HOB 45° elevated head of bed) and with an external abdominal pressure belt. Sixteen patients were included. Seven were not eligible for analysis due to unreliable IAPrect values. IAPrect was significantly higher than IAPves for all body positions (p 0.01) and the correlation between IAPves and IAPrect was poor and not significant in each position (p ≥ 0.25, R2 0.6, Lin's CCC 0.8, bias - 8.1 mmHg and precision of 5.6 mmHg with large limits of agreement between - 19 to 2.9 mmHg, high percentage error 67.3%, and low concordance 86.2%). Repeatability of IAPrect was not reliable (R = 0.539, p = 0.315). For both techniques, measurements with the external abdominal pressure belt were significantly higher compared to those without (p 0.03). IAPrect has important shortcomings making IAP estimation using a rectal catheter unfeasible because the numbers cannot be trusted nor validated.
Eur Heart J Cardiovasc Imaging. 2024 Mar 27;25(4):530-538. Exercise pulmonary hypertension by the mPAP/CO slope in primary mitral regurgitation
Sebastiaan Dhont, Jan Stassen, Lieven Herbots, Sarah Hoedemakers, Youri Bekhuis, Ruta Jasaityte, Sarah Stroobants, Thibault Petit, Elise Bakelants, Maarten Falter, Sara Moura Ferreira, Guido Claessen, Petra Nijst, Pieter M Vandervoort, Philippe B Bertrand, Jan Verwerft
PMID: 37976175 Abstract Aims: Exercise-induced pulmonary hypertension (PH), defined by a mean pulmonary arterial pressure over cardiac output (mPAP/CO) slope >3 mmHg/L/min, has important diagnostic and prognostic implications. The aim of this study is to investigate the value of the mPAP/CO slope in patients with more than moderate primary mitral regurgitation (MR) with preserved ejection fraction and no or discordant symptoms.
Methods and results: A total of 128 consecutive patients were evaluated with exercise echocardiography and cardiopulmonary testing. Clinical outcome was defined as the composite of mitral valve intervention, new-onset atrial fibrillation, cardiovascular hospitalization, and all-cause mortality. The mean age was 63 years, 61% were male, and the mean LVEF was 66 ± 6%. The mPAP/CO slope correlated with peak VO2 (r = -0.52, P 0.001), while the peak systolic pulmonary artery pressure (sPAP) did not (r = -0.06, P = 0.584). Forty-six per cent (n = 59) had peak exercise sPAP ≥60 mmHg, and 37% (n = 47) had mPAP/CO slope >3 mmHg/L/min. Event-free survival was 55% at 1 year and 46% at 2 years, with reduced survival in patients with mPAP/CO slope >3 mmHg/L/min (hazard ratio, 4.9; 95% confidence interval, 2.9-8.2; P 0.001). In 53 cases (41%), mPAP/CO slope and peak sPAP were discordant: patients with slope >3 mmHg/L/mmHg and sPAP 60 mmHg (n = 21) had worse outcome vs. peak sPAP ≥60 mmHg and normal slope (n = 32, log-rank P = 0.003). The mPAP/CO slope improved predictive models for outcome, incremental to resting and exercise sPAP, and peak VO2.
Conclusion: Exercise PH defined by the mPAP/CO slope >3 mmHg/L/min is associated with decreased exercise capacity and a higher risk of adverse events in significant primary MR and no or discordant symptoms. The slope provides a greater prognostic value than single sPAP measures and peak VO2.
Eur J Prev Cardiol. 2024 Mar 4;31(4):e9-e12. Effects of low vs. moderate intense resistance exercise training combined with endurance exercise training in patients with heart failure: a randomized clinical trial†
Tin Gojevic, Kristof Gelade, Natalia Turri Da Silva, Bart Tulleneers, Wilfried Mullens, Dominique Hansen
PMID: 37555298
Colorectal Dis. 2023 Mar;25(3):509-510. A stepwise approach to laparoscopic splenic flexure mobilization - A Video Vignette
Marcus Oosenbrug, Keegan Guidolin, Joep Knol, Armando G F Melani, Fayez Quereshy, Sami Chadi
PMID: 36151591
Ann Intensive Care. 2023 Mar 11;13(1):16. Unapparent systemic effects of regional anticoagulation with citrate in continuous renal replacement therapy: a narrative review Willem Boer, Walter Verbrugghe, Eric Hoste, Rita Jacobs, Philippe G Jorens
PMID: 36899104 Abstract
The use of citrate, through reversible binding of calcium, has become the preferred choice for anticoagulation in continuous renal replacement therapy in the critically ill patient. Though generally considered as very efficacious in acute kidney injury, this type of anticoagulation can cause acid-base disorders as well as citrate accumulation and overload, phenomena which have been well described. The purpose of this narrative review is to provide an overview of some other, non-anticoagulation effects of citrate chelation during its use as anticoagulant. We highlight the effects seen on the calcium balance and hormonal status, phosphate and magnesium balance, as well as oxidative stress resulting from these unapparent effects. As most of these data on these non-anticoagulation effects have been obtained in small observational studies, new and larger studies documenting both short- and long-term effects should be undertaken. Subsequent future guidelines for citrate-based continuous renal replacement therapy should take not only the metabolic but also these unapparent effects into account.
J Arthroplasty. 2023 Mar;38(3):511-518. Risk Factors for Iliopsoas Tendinopathy After Anterior Approach Total Hip Arthroplasty
Jeroen C F Verhaegen, Frans-Jozef Vandeputte, Robin Van den Broecke, Stijn Roose, Ronald Driesen, Annick Timmermans, Kristoff Corten
PMID: 36257506 Abstract Background: Iliopsoas tendinopathy is a cause of groin pain following total hip arthroplasty (THA). With the anterior approach becoming increasingly popular, our aim was to determine the prevalence of iliopsoas tendinopathy following anterior approach THA, to identify risk factors and to determine an influence on patient-reported outcomes. Methods: This is a retrospective case-control study of prospectively recorded data on 2,120 primary anterior approach THA (1,815 patients). The diagnosis of iliopsoas tendinopathy was based on (1) persistent postoperative groin pain, triggered by hip flexion; (2) absence of dislocation, infection, loosening, or fracture; and (3) decrease of pain after fluoroscopy-guided iliopsoas tendon sheet injection with xylocaine and corticosteroid. Outcomes included hip reconstruction (inclination/anteversion and leg-length), complication rates, reoperation rates, and patient-reported outcomes including Hip disability and Osteoarthritis Outcome Score. Results: Forty four patients (46 THAs) (2.2%) were diagnosed with iliopsoas tendinopathy. They were younger than patients who did not have iliopsoas tendinopathy (51 years [range, 27-76] versus 62 years [range, 20-90]; P .001). Logistic regression analyses demonstrated that younger age (P .001) and presence of a spine fusion (P = .008) (odds ratio 4.6) were the significant predictors of iliopsoas tendinopathy. These patients had lower Hip disability and Osteoarthritis Outcome scores, reported more often low back pain (odds ratio 4.8), and greater trochanter pain (odds ratio 5.4). Conclusion: We found an incidence of 2.2% of iliopsoas tendinopathy patients after anterior approach THA that compromised outcomes. Younger age and previous spine fusion were identified as most important risk factors. These patients were 5 times more likely to report low back pain and greater trochanter pain post-THA.
Arch Orthop Trauma Surg. 2023 Mar;143(3):1593-1598. Primary constrained-condylar-knee designs outperform posterior-stabilized and cruciate-retaining designs in high-grade varus osteoarthritic knees during short-term follow-up: a pilot study
William Colyn, J Neirynck, E Vanlommel, L Bruckers, J Bellemans
PMID: 35486158 Abstract Introduction: High-grade varus osteoarthrosis (OA) is characterized by a pronounced intra-articular varus deformity and associated insufficiency of the lateral ligamentous complex. When performing a total knee arthroplasty (TKA) in such a knee, traditionally the alignment is restored to neutral, and the medial soft tissue structures are released to compensate for the lateral laxity and balance the joint. However, another option would be to leave the medial soft tissues untouched and accept the lateral laxity but to compensate for it using an ML-stabilized constrained-condylar knee (CCK) design. Our aim was to prove our hypothesis that such knees would demonstrate better clinical stability and better functionality as well as subjective outcome scores.
Materials and methods: We searched our bicenter database of 912 primary TKAs (from 2016 to 2019) for primary TKA patients with a preoperative varus alignment of > 8°. After inclusion, 60 patients were divided into three groups by implant design: CCK (n = 21), posterior-stabilized (PS) (n = 20) and cruciate-retaining (CR) (n = 19). Oxford Knee Score (OKS), Forgotten Joint Score (FJS), Knee Society Score (KSS), UCLA-activity score, ML instability scores and both radiographic and clinical data were compared between groups. Results: ML stability was significantly better in CCK designs (86% grade 0) compared to CR (37% grade 0) (p = 0.004) but not PS (70% grade 0) designs. No grade II instability was present in CCK and PS implants compared to 16% of CR implants. KSS and UCLA-activity score were higher in CCK designs compared to PS (p = 0.027, p = 0.041) and CR designs (p 0.001, p = 0.007). OKS and FJS were higher in CCK designs compared to CR (p = 0.025, p = 0.008) but not to PS. Conclusion: The use of a CCK design to compensate for the lateral laxity in high-grade varus OA knees allowed to refrain from a medial release. CCK designs displayed improved clinical stability and better functionality as well as subjective outcome scores compared to less-constrained designs.
J Clin Med. 2023 Mar 15;12(6):2264. Promising Perinatal Outcome after Using a Simplified Low-Cost IVF Culture System Specifically Designed for Resource-Poor Countries Willem Ombelet, Jonathan Van Blerkom, Liesbeth Bruckers, Nathalie Dhont, Geeta Nargund, Rudi Campo
PMID: 36983264 Abstract
Background: Assisted reproductive techniques services are often not accessible to the majority of infertile couples in Low and Middle Income Countries (LMIC) due to high costs. Lowering IVF laboratory costs is a crucial step to make IVF affordable for a larger part of the world population. We developed a simplified culture system (SCS) which has proven to be effective, and the next step is to prove its safety. Methods: Preterm birth (PTB) and low birthweight (LBW) of 176 singletons born after using the SCS, 105 after fresh embryo transfer (fresh ET), and 71 after frozen embryo transfer (frozen ET) were compared with all IVF/ICSI singletons born in Belgium between 2013 and 2018. When comparing our 105 SCS babies born after fresh ET with all Belgian babies born after conventional IVF only, we also adjusted for 7 risk factors known to influence perinatal outcome, namelythe mother's age, day of transfer, pituitary inhibition protocol, rank of cycles, number of oocytes retrieved, number of embryos transferred, and gender of the baby. Findings: Before adjustment, we found a significantly higher PTB (10.2% vs. 3.8%, OR 2.852, 95% CI [1.042-7.803], p-value 0.0413) and LBW (9.8% vs. 2.9%, OR 3.692, 95% CI [1.163-11.721], p-value 0.0267) in the conventional IVF group versus SCS after fresh ET. After adjusting for seven risk parameters, these differences remained significant (PTB: OR 2.627, 95% CI [1.013-6.816], p-value 0.0471) and LBW: OR 3.267, 95% CI [1.118-9.549], p-value 0.0305). PTB and LBW between both groups was not significantly different for singletons born after frozen ET. Interpretation: Taking into account the small series, PTB and LBW rates in SCS singletons in FRET cycles are very reassuring and significantly lower compared to babies born after conventional IVF in Belgium. Being aware of its effectiveness, our results offer a good perspective for SCS to become an important tool to implement low-cost IVF in LMIC.Cancers (Basel). 2023 Apr 3;15(7):2127.
Pain Pract. 2024 Mar;24(3):525-552. 1. Lumbosacral radicular pain Laurens Peene, Steven P Cohen, Jan Willem Kallewaard, Andre Wolff, Frank Huygen, Antal van de Gaag, Steegers Monique, Kris Vissers, Chris Gilligan, Jan Van Zundert, Koen Van Boxem
PMID: 37985718 Abstract Introduction: Patients suffering lumbosacral radicular pain report radiating pain in one or more lumbar or sacral dermatomes. In the general population, low back pain with leg pain extending below the knee has an annual prevalence that varies from 9.9% to 25%. Methods: The literature on the diagnosis and treatment of lumbosacral radicular pain was reviewed and summarized.
Results: Although a patient's history, the pain distribution pattern, and clinical examination may yield a presumptive diagnosis of lumbosacral radicular pain, additional clinical tests may be required. Medical imaging studies can demonstrate or exclude specific underlying pathologies and identify nerve root irritation, while selective diagnostic nerve root blocks can be used to confirm the affected level(s). In subacute lumbosacral radicular pain, transforaminal corticosteroid administration provides short-term pain relief and improves mobility. In chronic lumbosacral radicular pain, pulsed radiofrequency (PRF) treatment adjacent to the spinal ganglion (DRG) can provide pain relief for a longer period in well-selected patients. In cases of refractory pain, epidural adhesiolysis and spinal cord stimulation can be considered in experienced centers. Conclusions: The diagnosis of lumbosacral radicular pain is based on a combination of history, clinical examination, and additional investigations. Epidural steroids can be considered for subacute lumbosacral radicular pain. In chronic lumbosacral radicular pain, PRF adjacent to the DRG is recommended. SCS and epidural adhesiolysis can be considered for cases of refractory pain in specialized centers.
Crit Rev Oncol Hematol. 2023 Mar:183:103926. Monoclonal gammopathy of renal significance: Multidisciplinary approach to diagnosis and treatment
Sabine Karam, Mohammad Haidous, Iman Abou Dalle, Amélie Dendooven, Nour Moukalled, Amaryllis Van Craenenbroeck, Ali Bazarbachi, Ben Sprangers
PMID: 36736510 Abstract
Monoclonal gammopathy of renal significance (MGRS) is a hemato-nephrological term referring to a heterogeneous group of kidney disorders characterized by direct or indirect kidney injury caused by a monoclonal immunoglobulin (MIg) produced by a B cell or plasma cell clone that does not meet current hematologic criteria for therapy. MGRS-associated kidney diseases are diverse and can result in the development of end stage kidney disease (ESKD). The diagnosis is typically made by nephrologists through a kidney biopsy. Many distinct pathologies have been identified and they are classified based on the site or composition of the deposited Mig, or according to histological and ultrastructural findings. Therapy is directed towards the identified underlying clonal population and treatment decisions should be coordinated between hematologists and nephrologists in a multidisciplinary fashion, depend on the type of MGRS, the degree of kidney function impairment and the risk of progression to ESKD.
Eur Heart J Cardiovasc Imaging. 2024 Mar 27;25(4):491-497. Temporal changes in coronary plaque as assessed by an artificial intelligence-based optical coherence tomography: from the first-in-human trial on DREAMS 3G scaffold
Hector M Garcia-Garcia, Ron Waksman, Gebremedhin D Melaku, Mohil Garg, Solomon Beyene, Adrian Wlodarczak, Ajay Kerai, Molly B Levine, René J van der Schaaf, Jan Torzewski, BertFerdinande, Javier Escaned, Juan F Iglesias, Johan Bennett, Gabor G Toth, Michael Joner, Ralph Toelg, Marcus Wiemer, Göran Olivecrona, Paul Vermeersch, Michael Haude
PMID: 37936296 Abstract Aims: The aim of the study is to assess the impact of the baseline plaque composition on the DREAMS 3G luminal late loss and to compare the serial plaque changes between baseline and 6 and 12 months (M) follow-up. Methods and results: A total of 116 patients were enrolled in the BIOMAG-I trial. Patients were imaged with optical coherence tomography (OCT) pre- and post-DREAMS 3G implantation and at 6 and 12 M. OCTPlus software uses artificial intelligence to assess composition (i.e. lipid, calcium, and fibrous tissue) of the plaque. The differences between the OCT-derived minimum lumen area (MLA) post-percutaneous coronary intervention and 12 M were grouped into three terciles. Patients with larger MLA differences at 12 M (P = 0.0003) had significantly larger content of fibrous tissue at baseline. There was a reduction of 24.8% and 20.9% in lipid area, both P 0.001, between the pre-DREAMS 3G OCT and the 6 and 12 M follow-up. Conversely, the fibrous tissue increased by 48.4% and 36.0% at 6 and 12 M follow-up, both P 0.001. Conclusion: The larger the fibrous tissue in the lesion at baseline, the larger the luminal loss seen at 6 and 12 M. Following the implantation of DREAMS 3G, favourable healing of the vessel coronary wall occurs as shown by a decrease in the lipid area and an increase in fibrous tissue.
Int J Cardiol. 2023 Mar 15:375:14-20. External validation of the PROGRESS-CTO complication risk scores: Individual patient data pooled analysis of 3 registries
Bahadir Simsek, Peter Tajti, Mauro Carlino, Soledad Ojeda, Manuel Pan, Stephane Rinfret, Evangelia Vemmou, Spyridon Kostantinis, Ilias Nikolakopoulos, Judit Karacsonyi, Joseph A Dens, Pierfrancesco Agostoni, Khaldoon Alaswad, Michael Megaly, Alexandre Avran, James W Choi, Farouc A Jaffer, Darshan Doshi, Dimitri Karmpaliotis, Jaikirshan J Khatri, Paul Knaapen, Alessio La Manna, James C Spratt, Masaki Tanabe, Simon Walsh, Olga C Mastrodemos, Salman Allana, Athanasios Rempakos, Bavana V Rangan, Omer Goktekin, Sevket Gorgulu, Paul Poommipanit, Kathleen E Kearney, William L Lombardi, J Aaron Grantham, Kambis Mashayekhi, Emmanouil S Brilakis, Lorenzo Azzalini
PMID: 36565956 Abstract Background: Chronic total occlusion (CTO) percutaneous coronary intervention (PCI) is associated with a considerable risk of complications, and risk stratification is of utmost importance. Aims: To assess the clinical usefulness of the recently developed PROGRESS-CTO (NCT02061436) complication risk scores in an independent cohort.
Methods: Individual patient data pooled analysis of 3 registries was performed. Results: Of the 4569 patients who underwent CTO PCI, 102 (2.2%) had major adverse cardiovascular events (MACE). Patients with MACE were older (69 ± 11 vs. 65 ± 10, p 0.001), more likely to have a history of prior coronary artery bypass graft surgery, and unfavorable angiographic characteristics J-CTO score (2.4 ± 1.2 vs. 2.1 ± 1.3, p = 0.007), including blunt stump (59% vs. 49%, p = 0.047). Technical success was lower in patients with MACE (59% vs. 86%, p 0.001). The area under the receiver operating characteristic curve of the PROGRESS-CTO complication risk models were as follows: MACE 0.72 (95% confidence interval [CI], 0.67-0.76), mortality 0.73 (95% CI, 0.61-0.85), and pericardiocentesis 0.69 (95% CI, 0.62-0.77) in the validation dataset. The observed complication rates increased with higher PROGRESS-CTO complication scores. The PROGRESS-CTO MACE score showed good calibration in this external cohort, with MACE rates similar to the original study: 0.7% (score 0-1), 1.5% (score 2), 2.2% (score 3), 3.8% (score 4), 4.9% (score 5), 5.8% (score 6-7). Conclusion: Given the good discriminative performance, calibration, and ease of calculation, the PROGRESS-CTO complication scores could help assess the risk of complications in patients undergoing CTO PCI.
BMC Musculoskelet Disord. 2023 Mar 25;24(1):224. Clinical phenotypes and prognostic factors in persons with hip osteoarthritis undergoing total hip arthroplasty: protocol for a longitudinal prospective cohort study (HIPPROCLIPS)
Abner Sergooris, Jonas Verbrugghe, Thomas Matheve, Maaike Van Den Houte, Bruno Bonnechère, Kristoff Corten, Katleen Bogaerts, Annick Timmermans
PMID: 36964541 Abstract Background: Large heterogeneity exists in the clinical manifestation of hip osteoarthritis (OA). It is therefore not surprising that pain and disability in individuals with hip OA and after total hip arthroplasty (THA) cannot be explained by biomedical variables alone. Indeed, also maladaptive pain-related cognitions and emotions can contribute to pain and disability, and can lead to poor treatment outcomes. Traumatic experiences, mental disorders, self-efficacy and social support can influence stress appraisal and strategies to cope with pain, but their influence on pain and disability has not yet been established in individuals with hip OA undergoing THA. This study aims (1) to determine the influence of traumatic experiences and mental disorders on pain processing before and shortly after THA (2) to identify preoperative clinical phenotypes in individuals with hip OA eligible for THA, (3) to identify pre- and early postoperative prognostic factors for outcomes in pain and disability after THA, and (4) to identify postoperative clinical phenotypes in individuals after THA. Methods: This prospective longitudinal cohort study will investigate 200 individuals undergoing THA for hip OA. Phenotyping variables and candidate prognostic factors include pain-related fear-avoidance behaviour, perceived injustice, mental disorders, traumatic experiences, self-efficacy, and social support. Peripheral and central pain mechanisms will be assessed with thermal quantitative sensory testing. The primary outcome measure is the hip disability and osteoarthritis outcome score. Other outcome measures include performance-based measures, hip muscle strength, the patient-specific functional scale, pain intensity, global perceived effect, and outcome satisfaction. All these measurements will be performed before surgery, as well as 6 weeks, 3 months, and 12 months after surgery. Pain-related cognitions and emotions will additionally be assessed in the early postoperative phase, on the first, third, fifth, and seventh day after THA. Main statistical methods that will be used to answer the respective research questions include: LASSO regression, decision tree learning, gradient boosting algorithms, and recurrent neural networks. Discussion: The identification of clinical phenotypes and prognostic factors for outcomes in pain and disability will be a first step towards pre- and postoperative precision medicine for individuals with hip OA undergoing THA.
Circ Arrhythm Electrophysiol. 2023 Mar;16(3):e011780. Paroxysmal Atrial Fibrillation Ablation Using a Novel Variable-Loop Biphasic Pulsed Field Ablation Catheter Integrated With a 3-Dimensional Mapping System: 1-Year Outcomes of the Multicenter inspIRE Study
Mattias Duytschaever, Tom De Potter, Massimo Grimaldi, Ante Anic, Johan Vijgen, Petr Neuzil, Hugo Van Herendael, Atul Verma, Allan Skanes, Daniel Scherr, Helmut Pürerfellner, Gediminas Rackauskas, Pierre Jaïs, Vivek Y Reddy; inspIRE Trial Investigators
PMID: 36735937 Abstract Background: The inspIRE study (Study for Treatment of Paroxysmal Atrial Fibrillation [PAF] by Pulsed Field Ablation [PFA] System With Irreversible Electroporation [IRE]) evaluated safety and effectiveness of a fully integrated biphasic pulsed field ablation (PFA) system with a variable-loop circular catheter for the treatment of drug-refractory paroxysmal atrial fibrillation. Methods: Subjects underwent pulmonary vein (PV) isolation with the PFA system, using at least 12 applications per vein; adenosine/isoproterenol was administered to confirm entrance block. Wave I assessed initial safety, including for esophageal lesions, silent cerebral lesions, and PV stenosis. Wave II (pivotal phase) tested (1) primary safety, incidence of early-onset primary adverse events, and (2) primary effectiveness, confirmed PV isolation with freedom from documented atrial arrhythmia at 12 months. The study design specified an interim analysis to determine early success once 30 subjects reached the 12-month follow-up and all subjects reached 3-month follow-up. Results: Across 13 centers in Europe/Canada, 226 subjects were enrolled, met criteria for safety and effectiveness evaluations, and received PFA (Wave I, 40; Wave II, 186). Wave I demonstrated no esophageal thermal lesions or PV stenosis. Among 39 subjects with cerebral magnetic resonance imaging, silent cerebral lesions were detected in 4 of the first 6 subjects, after which workflow enhancements, including a 10-second pause between PFA applications, were implemented; subsequently, only 4 of 33 subjects had silent cerebral lesions. In the Wave II phase, no primary adverse events were reported. Upon declaring early success, 83 subjects reached 12-month follow-up. With 100% entrance block, PV isolation without acute reconnection was achieved in 97.1% of targeted veins. For Wave II, the primary effectiveness end point per Kaplan-Meier at the time of interim analysis was 70.9%; 12-month freedom from symptomatic atrial fibrillation/atrial flutter/atrial tachycardia recurrence and repeat ablation was 78.9% and 92.3%, respectively. Total procedure and transpired PFA times were 70.1±27.7 and 26.7±14.0 minutes, respectively. Conclusions: The inspIRE trial confirmed the safety and effectiveness of the novel mapping-integrated PFA system.
Catheter Cardiovasc Interv. 2023 Apr;101(5):918-931. Gender differences in percutaneous coronary intervention for chronic total occlusions from the ERCTO study
Alexandre Avran, Andrea Zuffi, Cecilia Gobbi, Alessio Gasperetti, Marco Schiavone, Gerald S Werner, Mashayekhi Kambis, Nicolas Boudou, Alfredo R Galassi, George Sianos, Moussa Idali, Roberto Garbo, Andrea Gagnor, Gabriele Gasparini, Alexander Bufe, Leszek Bryniarski, Artis Kalnins, Daniel Weilenmann, Jaroslaw Wojcik, Pierfrancesco Agostoni, Nenad Z Bozinovic, Mauro Carlino, Sergey Furkalo, David Hildick-Smith, Laurent Drogoul, Julien Lemoine, Antonio Serra, Stefano Carugo, Imre Ungi, Joseph Dens, Nicolaus Reifart, Joseph Cosma, Vincenzo Mallia, Giuseppe Vadalà, Giuseppe Biondi-Zoccai, Carlo Di Mario
PMID: 36883958 Abstract Background: Gender-specific data addressing percutaneous coronary intervention (PCI) of chronic total occlusion (CTO) in female patients are scarce and based on small sample size studies. Aims: We aimed to analyze gender-differences regarding in-hospital clinical outcomes after CTO-PCI. Methods: Data from 35,449 patients enrolled in the prospective European Registry of CTOs were analyzed. The primary outcome was the comparison of procedural success rate in the two cohorts (women vs. men), defined as a final residual stenosis less than 20%, with Thrombolysis In Myocardial Infarction grade flow = 3. In-hospital major adverse cardiac and cerebrovascular events (MACCEs) and procedural complications were deemed secondary outcomes. Results: Women represented 15.2% of the entire study population. They were older and more likely to have hypertension, diabetes, and renal failure, with an overall lower J-CTO score. Women showed a higher procedural success rate (adjusted OR [aOR] = 1.115, confidence interval [CI]: 1.011-1.230, p = 0.030). Apart from previous myocardial infarction and surgical revascularization, no other significant gender differences were found among predictors of procedural success. Antegrade approach with true-to-true lumen techniques was more commonly used than retrograde approach in females. No gender differences were found regarding in-hospital MACCEs (0.9% vs. 0.9%, p = 0.766), although a higher rate of procedural complications was observed in women, such as coronary perforation (3.7% vs. 2.9%, p 0.001) and vascular complications (1.0% vs. 0.6%, p 0.001). Conclusions: Women are understudied in contemporary CTO-PCI practice. Female sex is associated with higher procedural success after CTO-PCI, yet no sex differences were found in terms of in-hospital MACCEs. Female sex was associated with a higher rate of procedural complications.
Eur J Heart Fail. 2023 Apr;25(4):562-572. Use of mechanical circulatory support in patients with non-ischaemic cardiogenic shock
Benedikt Schrage, Jonas Sundermeyer, Benedikt Norbert Beer, Letizia Bertoldi, Alexander Bernhardt, Stefan Blankenberg, Jeroen Dauw, Zouhir Dindane, Dennis Eckner, Ingo Eitel, Tobias Graf, Patrick Horn, Paulus Kirchhof, Stefan Kluge, Axel Linke, Ulf Landmesser, Peter Luedike, Enzo Lüsebrink, Norman Mangner, Octavian Maniuc, Sven Möbius Winkler, Peter Nordbeck, Martin Orban, Federico Pappalardo, Matthias Pauschinger, Michal Pazdernik, Alastair Proudfoot, Matthew Kelham, Tienush Rassaf, Hermann Reichenspurner, Clemens Scherer, Paul Christian Schulze, Robert H G Schwinger, Carsten Skurk, Marek Sramko, Guido Tavazzi, Holger Thiele, Luca Villanova, Nuccia Morici, Antonia Wechsler, Ralf Westenfeld, Ephraim Winzer, Dirk Westermann
PMID: 36781178
Abstract Aims: Despite its high incidence and mortality risk, there is no evidence-based treatment for non-ischaemic cardiogenic shock (CS). The aim of this study was to evaluate the use of mechanical circulatory support (MCS) for non-ischaemic CS treatment. Methods and results: In this multicentre, international, retrospective study, data from 890 patients with non-ischaemic CS, defined as CS due to severe de-novo or acute-on-chronic heart failure with no need for urgent revascularization, treated with or without active MCS, were collected. The association between active MCS use and the primary endpoint of 30-day mortality was assessed in a 1:1 propensity-matched cohort. MCS was used in 386 (43%) patients. Patients treated with MCS presented with more severe CS (37% vs. 23% deteriorating CS, 30% vs. 25% in extremis CS) and had a lower left ventricular ejection fraction at baseline (21% vs. 25%). After matching, 267 patients treated with MCS were compared with 267 patients treated without MCS. In the matched cohort, MCS use was associated with a lower 30-day mortality (hazard ratio 0.76, 95% confidence interval 0.59-0.97). This finding was consistent through all tested subgroups except when CS severity was considered, indicating risk reduction especially in patients with deteriorating CS. However, complications occurred more frequently in patients with MCS; e.g. severe bleeding (16.5% vs. 6.4%) and access-site related ischaemia (6.7% vs. 0%). Conclusion: In patients with non-ischaemic CS, MCS use was associated with lower 30-day mortality as compared to medical therapy only, but also with more complications. Randomized trials are needed to validate these findings.
Eur J Emerg Med. 2023 Apr 1;30(2):91-101. Impact of worsening renal function detected at emergency department arrival on acute heart failure short-term outcomes
Lluís Llauger, Begoña Espinosa, Zubaid Rafique, Stephen Boone, Greg Beuhler, Javier Millán-Soria, Víctor Gil, Javier Jacob, Aitor Alquézar-Arbé, María Campos-Meneses, Rosa Escoda, Josep Tost, Enrique Martín-Mojarro, Alfons Aguirre, María Luisa López-Grima, Julio Núñez, Wilfried Mullens, Pedro Lopez-Ayala, Christian Mueller, Pere Llorens, Frank Peacock, Òscar Miró; (on behalf of the ICA-SEMES Research Group)
PMID: 36787242 Abstract Background and importance: Deterioration of renal function with respect to baseline during an acute heart failure (AHF) episode is frequent, but impact on outcomes is still a matter of debate. Objective: To investigate the association of creatinine deterioration detected at emergency department (ED) arrival and short-term outcomes in patients with AHF. Design: Secondary analysis of a large multipurpose registry. Settings and participants: Patients with AHF were diagnosed in 10 Spanish ED for whom a previous baseline creatinine was available. Exposure: Difference between creatinine at ED arrival and at baseline was calculated (∂-creatinine). Outcome measures and analysis: Primary outcome was 30-day all-cause death, and secondary outcomes were inhospital all-cause death, prolonged hospitalization (>7 days) and 7-day postdischarge adverse events. Associations between ∂-creatinine and outcomes were explored using logistic regression by restricted cubic spline (RCS) curves and expressed as odds ratio (OR) with 95% confidence interval (CI), taking ∂-creatinine = 0 mg/dl as reference. Curves were adjusted by age, sex, comorbidities, patient baseline status, chronic treatments, and vitals and laboratory results at ED arrival. Interactions for the primary outcome also were investigated. Main results: We analyzed 3036 patients (median age = 82 years; IQR = 75-87; women = 55%), with ∂-creatinine ranged from -0.3 to 3 mg/dl. The 30-day mortality was 11.6%. Increments of ∂-creatinine were associated with progressive increase in risk of 30-day death, although adjustment attenuated this association: ∂-creatinine of 0.3/1/2/3 mg/dl were, respectively, associated with adjusted OR of 1.41 (1.02-1.95), 1.69 (1.02-2.80), 1.46 (0.56-3.80) and 1.27 (0.27-5.83). Distinctively significant higher risk was found for patients over 80 years old, female, nondiabetic, functionally disabled and on digoxin therapy. With respect to secondary outcomes, inhospital mortality was 8.1%, prolonged hospitalization was 33.6% and 7-day postdischarge adverse event was 9.7%. Inhospital death steadily increased with increments in ∂-creatinine [from 1.50 (1.04-2.17) with ∂-creatinine = 0.3 to 3.78 (0.78-18.3) with ∂-creatinine = 3], as well as prolonged hospitalization did [from 1.41 (1.11-1.77) to 2.24 (1.51-3.33), respectively]. Postdischarge adverse events were not associated with ∂-creatinine. Conclusion: WRF detected at ED arrival has prognostic value in AHF, being associated with increased risk of death and prolonged hospitalization. These associations showed different patterns of risk but, remarkably, risk started with increments as low as 0.3 mg/dl.
Lancet. 2023 Apr 8;401(10383):1172-1182. Immediate versus staged complete revascularisation in patients presenting with acute coronary syndrome and multivessel coronary disease (BIOVASC): a prospective, open-label, non-inferiority, randomised trial
Roberto Diletti, Wijnand K den Dekker, Johan Bennett, Carl E Schotborgh, Rene van der Schaaf, Manel Sabaté, Raúl Moreno, Koen Ameloot, Rutger van Bommel, Daniele Forlani, Bert van Reet, Giovanni Esposito, Maurits T Dirksen, Willem P T Ruifrok, Bert R C Everaert, Carlos Van Mieghem, Jacob J Elscot, Paul Cummins, Mattie Lenzen, Salvatore Brugaletta, Eric Boersma, Nicolas M Van Mieghem; BIOVASC Investigators Abstract Background: In patients with acute coronary syndrome and multivessel coronary disease, complete revascularisation by percutaneous coronary intervention (PCI) is associated with improved clinical outcomes. We aimed to investigate whether PCI for non-culprit lesions should be attempted during the index procedure or staged. Methods: This prospective, open-label, non-inferiority, randomised trial was done at 29 hospitals across Belgium, Italy, the Netherlands, and Spain. We included patients aged 18-85 years presenting with ST-segment elevation myocardial infarction or non-ST-segment elevation acute coronary syndrome and multivessel (ie, two or more coronary arteries with a diameter of 2·5 mm or more and ≥70% stenosis based on visual estimation or positive coronary physiology testing) coronary artery disease with a clearly identifiable culprit lesion. A web-based randomisation module was used to randomly assign patients (1:1), with a random block size of four to eight, stratified by study centre, to undergo immediate complete revascularisation (PCI of the culprit lesion first, followed by other non-culprit lesions deemed to be clinically significant by the operator during the index procedure) or staged complete revascularisation (PCI of only the culprit lesion during the index procedure and PCI of all non-culprit lesions deemed to be clinically significant by the operator within 6 weeks after the index procedure). The primary outcome was the composite of all-cause mortality, myocardial infarction, any unplanned ischaemia-driven revascularisation, or cerebrovascular events at 1 year after the index procedure. Secondary outcomes included all-cause mortality, myocardial infarction, and unplanned ischaemia-driven revascularisation at 1 year after the index procedure. Primary and secondary outcomes were assessed in all randomly assigned patients by intention to treat. Non-inferiority of immediate to staged complete revascularisation was considered to be met if the upper boundary of the 95% CI of the hazard ratio (HR) for the primary outcome did not exceed 1·39. This trial is registered with ClinicalTrials.gov, NCT03621501. Findings: Between June 26, 2018, and Oct 21, 2021, 764 patients (median age 65·7 years [IQR 57·2-72·9] and 598 [78·3%] males) were randomly assigned to the immediate complete revascularisation group and 761 patients (median age 65·3 years [58·6-72·9] and 589 [77·4%] males) were randomly assigned to the staged complete revascularisation group, and were included in the intention-to-treat population. The primary outcome at 1 year occurred in 57 (7·6%) of 764 patients in the immediate complete revascularisation group and in 71 (9·4%) of 761 patients in the staged complete revascularisation group (HR 0·78, 95% CI 0·55-1·11, pnon-inferiority=0·0011). There was no difference in all-cause death between the immediate and staged complete revascularisation groups (14 [1·9%] vs nine [1·2%]; HR 1·56, 95% CI 0·68-3·61, p=0·30). Myocardial infarction occurred in 14 (1·9%) patients in the immediate complete revascularisation group and in 34 (4·5%) patients in the staged complete revascularisation group (HR 0·41, 95% CI 0·22-0·76, p=0·0045). More unplanned ischaemia-driven revascularisations were performed in the staged complete revascularisation group than in the immediate complete revascularisation group (50 [6·7%] patients vs 31 [4·2%] patients; HR 0·61, 95% CI 0·39-0·95, p=0·030). Interpretation: In patients presenting with acute coronary syndrome and multivessel disease, immediate complete revascularisation was non-inferior to staged complete revascularisation for the primary composite outcome and was associated with a reduction in myocardial infarction and unplanned ischaemia-driven revascularisation.
Cancers (Basel). 2023 Apr 3;15(7):2127. NMR-Metabolomics Reveals a Metabolic Shift after Surgical Resection of Non-Small Cell Lung Cancer Elien Derveaux, Melvin Geubbelmans, Maarten Criel, Ingel Demedts, Ulrike Himpe, Kurt Tournoy, Piet Vercauter, Erik Johansson, Dirk Valkenborg, Karolien Vanhove, Liesbet Mesotten, Peter Adriaensens, Michiel Thomeer
PMID: 37046788 Abstract Background: Lung cancer can be detected by measuring the patient's plasma metabolomic profile using nuclear magnetic resonance (NMR) spectroscopy. This NMR-based plasma metabolomic profile is patient-specific and represents a snapshot of the patient's metabolite concentrations. The onset of non-small cell lung cancer (NSCLC) causes a change in the metabolite profile. However, the level of metabolic changes after complete NSCLC removal is currently unknown. Patients and methods: Fasted pre- and postoperative plasma samples of 74 patients diagnosed with resectable stage I-IIIA NSCLC were analyzed using 1H-NMR spectroscopy. NMR spectra (s = 222) representing two preoperative and one postoperative plasma metabolite profile at three months after surgical resection were obtained for all patients. In total, 228 predictors, i.e., 228 variables representing plasma metabolite concentrations, were extracted from each NMR spectrum. Two types of supervised multivariate discriminant analyses were used to train classifiers presenting a strong differentiation between the pre- and postoperative plasma metabolite profiles. The validation of these trained classification models was obtained by using an independent dataset. Results: A trained multivariate discriminant classification model shows a strong differentiation between the pre- and postoperative NSCLC profiles with a specificity of 96% (95% CI [86-100]) and a sensitivity of 92% (95% CI [81-98]). Validation of this model results in an excellent predictive accuracy of 90% (95% CI [77-97]) and an AUC value of 0.97 (95% CI [0.93-1]). The validation of a second trained model using an additional preoperative control sample dataset confirms the separation of the pre- and postoperative profiles with a predictive accuracy of 93% (95% CI [82-99]) and an AUC value of 0.97 (95% CI [0.93-1]). Metabolite analysis reveals significantly increased lactate, cysteine, asparagine and decreased acetate levels in the postoperative plasma metabolite profile. Conclusions: The results of this paper demonstrate that surgical removal of NSCLC generates a detectable metabolic shift in blood plasma. The observed metabolic shift indicates that the NSCLC metabolite profile is determined by the tumor's presence rather than donor-specific features. Furthermore, the ability to detect the metabolic difference before and after surgical tumor resection strongly supports the prospect that NMR-generated metabolite profiles via blood samples advance towards early detection of NSCLC recurrence.
Am J Cardiol. 2023 Apr 15:193:83-90. Sex Differences in Extensive Mitral Annular Calcification With Associated Mitral Valve Dysfunction
Timothy W Churchill , Evin Yucel, Samuel Bernard, Mayooran Namasivayam, Yasufumi Nagata, Emily S Lau, Sebastien Deferm, Wei He, Jacqueline S Danik, Danita Y Sanborn, Michael H Picard, Robert A Levine, Judy Hung, Philippe B Bertrand
PMID: 36881941 Abstract
Mitral annular calcification (MAC)-related mitral valve (MV) dysfunction is an increasingly recognized entity, which confers a high burden of morbidity and mortality. Although more common among women, there is a paucity of data regarding how the phenotype of MAC and the associated adverse clinical implications may differ between women and men. A total of 3,524 patients with extensive MAC and significant MAC-related MV dysfunction (i.e., transmitral gradient ≥3 mm Hg) were retrospectively analyzed from a large institutional database, with the goal of defining gender differences in clinical and echocardiographic characteristics and the prognostic importance of MAC-related MV dysfunction. We stratified patients into low- (3 to 5 mm Hg), moderate- (5 to 10 mm Hg), and high- (≥10 mm Hg) gradient groups and analyzed the gender differences in phenotype and outcome. The primary outcome was all-cause mortality, assessed using adjusted Cox regression models. Women represented the majority (67%) of subjects, were older (79.3 ± 10.4 vs 75.5 ± 10.9 years, p 0.001) and had a lower burden of cardiovascular co-morbidities than men. Women had higher transmitral gradients (5.7 ± 2.7 vs 5.3 ± 2.6 mm Hg, p 0.001), more concentric hypertrophy (49% vs 33%), and more mitral regurgitation. The median survival was 3.4 years (95% confidence interval 3.0 to 3.6) among women and 3.0 years (95% confidence interval 2.6 to 4.5) among men. The adjusted survival was worse among men, and the prognostic impact of the transmitral gradient did not differ overall by gender. In conclusion, we describe important gender differences among patients with MAC-related MV dysfunction and show worse adjusted survival among men; although, the adverse prognostic impact of the transmitral gradient was similar between men and women.
Acta Neurol Belg. 2023 Apr;123(2):545-551. Multicentric validation of a reduced features case-mix set for predicting functional outcome after ischemic stroke in Belgium Sofie Ordies, Anouk Lesenne, Kim Bekelaar, Jelle Demeestere, Robin Lemmens, Peter Vanacker,Dieter Mesotten; Monitoring of Stroke Activities and Outcome Consortium
PMID: 36409450 Abstract Introduction: Ischemic stroke is the second cause of death and leading cause of severe disability worldwide. A reduced features set of CT-DRAGON (age, NIHSS on admission and pre-stroke mRS) predicts 90-day functional outcome after stroke in a single center. The current study was designed to validate this adapted CT-DRAGON score in three major Belgian hospitals, in the framework of future case-mix adjustment. Methods: This retrospective study included stroke patients, treated by thrombolysis, thrombectomy, a combination of both or neither thrombolysis or thrombectomy (conservative treatment) in 2019. Patient characteristics and 90-day mRS were collected. Multivariable logistic regression analysis of 90-day mRS 0-2 vs. 3-6 and 0-5 vs. 6 with the reduced features set was performed. Discriminative performance was assessed by the area under the receiver operating characteristic curve (AUROC). Results: Thirty-three percent of patients (413/1243) underwent treatment. Majority of strokes was treated conservatively (n = 830, 67%), 18% (n = 225) was treated by thrombolysis, 7% (n = 88) by thrombectomy and 8% (n = 100) by thrombolysis and thrombectomy. Age, NIHSS and pre-stroke mRS were independently associated with 90-day mRS 0-2 (all p ≤ 0.0001, AUROC 0.88). When treatment modality was added in the model, age, NIHSS, pre-stroke mRS and treatment modality were independently associated with 90-day mRS 0-2 (p 0.0001, p 0.0001, p 0.0001 and p = 0.0001) AUROC 0.89). Age, NIHSS, pre-stroke mRS and treatment modality were independently associated with 90-day survival (p = 0.0001, p 0.0001, p 0.0001 and p = 0.008, AUROC 0.86). Discussion: The reduced features set (age, NIHSS and pre-mRS) was independently associated with long-term functional outcome in a Belgian multicentric cohort, making it useful for case-mix adjustments in Belgian stroke centers. Treatment modality was associated with long-term outcome.
J Cardiothorac Surg. 2023 Apr 8;18(1):116. The effects of differing anticoagulant regimes on blood quality after cell salvage in coronary artery bypass grafting (CABG): a pilot study Willem Boer, Mathias van Tornout, Maarten Brusseleers, Maarten Strauven, Pieter de Vooght, Margot Vander Laenen, Eric Hoste, Philippe G Jorens
PMID: 37031168 Abstract Background: Cell salvage reduces allogenic blood transfusion requirements in surgery. We present a pilot study exploring the impact of anticoagulant choice, citrate or heparin, on the quality of cell salvaged blood in adults undergoing coronary artery bypass grafting (CABG).
Materials and methods: Elective on pump CABG patients were randomly allocated to citrate or heparin anticoagulation. We measured red blood cell characteristics and inflammation in both the blood collection reservoir and the washed red blood cell concentrate. Postoperatively, the level of biomarkers and the coagulation profile in the peripheral blood as well as the transfusion requirements of allogenic blood products were studied. Results: Thirty eight patients were included, 19 in the citrate group and 19 in the heparin group. Baseline characteristics were similar. In the washed red blood cell concentrate, Mean Hb (g/dl) and Ht (%) were lower in the citrate group [Hb: 18.1 g/dL (SD 1.3) vs. 21.1 (1.6), p 0.001; Ht: 59.9% (54.7-60.9) vs. 63.7% (62.3-64.8); p 0.001]; Mean corpuscular volume (MCV, μm 3) was higher [99.1fL (9.4) vs. 88 (4.2), p 0.001] and mean corpuscular hemoglobin concentration (MCHC, g/dl) lower in the citrate group [31.9 g/dl (29.6-32.4) vs. 33.6 (33.1-34.0) p 0.001]. Thrombocyte count (1000/μl) was higher in the citrate group [31.0 (26.0-77.0) vs. 13.0 (10.0-39.0); p = 0.006]. There were no differences in the requirement for allogenic blood products' transfusion (intraoperatively and postoperatively) or in the coagulation parameters after washed red blood cell concentrate infusion. Higher IL-10 was found in the citrate group in the blood collection reservoir, higher neutrophil-derived myeloperoxidase (MPO) in the heparin group after washed red blood cell concentrate infusion. Conclusion: Though red blood cells in washed red blood cell concentrate were more swollen and diluted in the citrate group with more residual thrombocytes, published quality guidelines were met in both groups. Our pilot study suggests that differences in inflammatory markers in the blood collection reservoir and after infusion of washed red blood cell concentrate indicate a possible pro-inflammatory effect of heparin compared to citrate. A larger study is warranted to confirm these results and their possible clinical consequences.
J Hand Surg Eur Vol. 2023 Apr;48(4):364-367. Re: Hansen TB. Trapeziometacarpal joint osteoarthritis: ongoing search for the ideal solution. J Hand Surg Eur. 2022, 47: 976-8 Joris Duerinckx, Jean Goubau
PMID: 36756705
No abstract available
J ISAKOS. 2023 Apr;8(2):68-73. Changes in coronal knee-alignment parameters during the osteoarthritis process in the varus knee
William Colyn, L Bruckers, L Scheys, J Truijen, K Smeets, J Bellemans
PMID: 36646170
Abstract Objectives: The idea to aim for an "individualized" alignment, whereby the constitutional alignment is restored, has gained much interest among knee surgeons. This requires insight into the prediseased, natural alignment of our patients' knees. The aim of this study is (1) to determine how the hip-knee-ankle (HKA) angle is influenced during the arthritic process and (2) to investigate the correlation between joint line changes and the progression of osteoarthritis (OA). It is our hypothesis that the most pronounced coronal parameter changes appear at the proximal tibia and at the joint line.
Methods: One hundred sequential full-length X-rays with a minimum follow-up of 1 year were retrospectively reviewed from a radiographic joint database. Patients had to be at least 50 years of age needed to have an HKA angle of more than 1.3° varus to be included. Patients with ipsilateral total hip arthroplasty, femoral or tibial fracture, osteotomy, or ligamentous repair were excluded. Fifteen alignment parameters were investigated on the sequential full-length X-rays. Moreover, the relationship between the alignment parameters and the Kellgren-Lawrence grade (KL grade) was determined by using linear mixed models. Results: A progressive KL grade is associated with an increase of the HKA (p 0.001). Mostly, HKA differs due to decrease of the medial tibial plateau (MPTA) angle (0.93°) and an increase of the joint line angle (JLCA) (0.86°). The mLDFA demonstrated the most pronounced changes in the beginning of OA (KL grade 1-2) (p = 0.049). In particular, the MPTA becomes considerably smaller (p = 0.004) in the later stage of OA (KL grade 3). Also, a progressive increase of the JLCA (p 0.001) is observed upwards of KL grade 3.
Conclusion: By comparing consecutive full-length X-rays in the same patients, it is possible to define the coronal alignment changes during the arthritic process. The HKA angle increases according the arthritic progression, whereby the most pronounced changes appear at the proximal tibia (MPTA) and at the joint line (JLCA).The alignment changes in varus OA knees can be divided in three stadia: (1) erosion of the distal medial femoral condyle, (2) erosion of the medial tibial plateau, and (3) a progressive increase of the joint line angle.
ESC Heart Fail. 2023 Apr;10(2):907-916. Mixed-methods evaluation of a multifaceted heart failure intervention in general practice: the OSCAR-HF pilot study
Miek Smeets, Willem Raat, Bert Aertgeerts, Joris Penders, Jan Vercammen, Walter Droogne, Wilfried Mullens, Stefan Janssens, Bert Vaes
PMID: 36461750 Abstract Aims: Heart failure (HF) is an important health problem for which multidisciplinary care is recommended, yet few studies involve primary care practitioners in the multidisciplinary management of HF. We set up a multifaceted prospective observational trial, OSCAR-HF, piloting audit and feedback, natriuretic peptide testing at the point of care, and the assistance of a specialist HF nurse in primary care. The aim was to optimize HF care in general practice. Methods and results: This is an analysis at 6 month follow-up of the study interventions of the OSCAR-HF pilot study, a nonrandomized, noncontrolled prospective observational trial conducted in eight Belgian general practices [51 general practitioners (GPs)]. Patients who were assessed by their GP to have HF constituted the OSCAR-HF study population. We used descriptive statistics and mixed-effects modelling for the quantitative analysis and thematic analysis of the focus group interviews. There was a 10.2% increase in the registered HF population after 6 months of follow-up (n = 593) compared with baseline (n = 538) and a 27% increase in objectified HF diagnoses (baseline n = 359 to 456 at T6 M). Natriuretic peptide testing (with or without referral) accounted for 54% (n = 60/111) of the newly registered HF diagnoses. There was no difference in the proportion of patients with HF with reduced ejection fraction who received their target dosage of renin-angiotensin-aldosterone system inhibitors or beta-blockers at 6 months compared with baseline (P = 0.9). Patients who received an HF nurse intervention (n = 53) had significantly worse quality of life at baseline [difference in Minnesota Living with Heart Failure Questionnaire (MLHFQ) score 9.2 points; 95% confidence interval (CI) 4.0, 14] and had a significantly greater improvement in quality-of-life scores at the 6 month follow-up [change in MLHFQ score -9.8 points; 95% CI -15, -4.5] than patients without an HF nurse intervention. GPs found audit and feedback valuable but time intensive. Natriuretic peptides were useful, but the point-of-care test was impractical, and the assistance of an HF nurse was a useful addition to routine HF care. Conclusions: The use of audit and feedback combined with natriuretic peptide testing was a successful strategy to increase the number of registered and objectified HF diagnoses at 6 months. GPs and HF nurses selected patients with worse quality-of-life scores at baseline for the HF nurse intervention, which led to a significantly greater improvement in quality-of-life scores at the 6 month follow-up compared with patients without an HF nurse intervention. The interventions were deemed feasible and useful by the participating GPs with some specific remarks that can be used for optimization.
Acta Clin Belg. 2023 Apr;78(2):140-159. Preterm birth during the COVID-19 pandemic: more, less, or just the same?
Isabelle Dehaene, Caroline Van Holsbeke, Kristien Roelens, Noortje Nvh van Oostrum, Katrien Nulens, Koenraad Smets, Marie-Rose Van Hoestenberghe, Gunnar Naulaers, Roland Devlieger
PMID: 35731600 Abstract Objectives: Coronavirus disease (COVID-19) and its mitigation measures have been associated with changes in preterm birth (PTB) incidences. The objective of this paper is to summarize and comment on the literature on COVID-19 and PTB and to compare PTB incidence between 2019 (pre-COVID-19) and 2020 (COVID-19) in three Belgian tertiary care hospitals. Methods: A non-systematic review on COVID-19 and PTB was performed, and literature was summarized in a table. Preterm birth rates at Ghent University Hospital, Ziekenhuis Oost-Limburg, and University Hospital Leuven in 2019 and 2020 were compared. Chi-square and Fisher's exact tests were used to compare PTB rates between 2019 and 2020, and Kaplan Meier survival analysis was used to compare pregnancy duration. The mean outcome measure was PTB incidence in 2020 (COVID-19) compared with PTB incidence in 2019 (pre-COVID-19). Results: Some (parts of) countries report decreases in PTB rates, others report no differences in incidence, and a minority of countries report an increased incidence of PTB. Almost all studies only consider live-births. In three tertiary care hospitals in Flanders, there were no differences in PTB rates before and during the COVID-19 pandemic. Conclusion: The impact of the (mitigation measures during the) COVID-19 pandemic on PTB incidence is unclear and difficult to explore. To enable a correct interpretation, all conceptions before and during the pandemic should be taken into consideration, as well as all births, still or alive.
Perfusion. 2023 Apr 17:2676591231170978. Hyperlactatemia and poor outcome After postcardiotomy veno-arterial extracorporeal membrane oxygenation: An individual patient data meta-Analysis
Fausto Biancari, Alexander Kaserer, Andrea Perrotti, Vito G Ruggieri, Sung-Min Cho, Jin Kook Kang, Magnus Dalén, Henryk Welp, Kristján Jónsson, Sigurdur Ragnarsson, Francisco J Hernández Pérez, Giuseppe Gatti, Khalid Alkhamees, Antonio Loforte, Andrea Lechiancole, Stefano Rosato, Cristiano Spadaccio, Matteo Pettinari, Giovanni Mariscalco, Timo Mäkikallio, Sebastian D Sahli, Camilla L'Acqua, Amr A Arafat, Monirah A Albabtain, Mohammed M AlBarak, Mohamed Laimoud, Ilija Djordjevic, Ihor Krasivskyi 28, Robertas Samalavicius, Lina Puodziukaite, Marta Alonso-Fernandez-Gatta, Donat R Spahn, Antonio Fiore
PMID: 37066850 Abstract Introduction: Postcardiotomy veno-arterial extracorporeal membrane oxygenation (V-A-ECMO) is associated with significant mortality. Identification of patients at very high risk for death is elusive and the decision to initiate V-A-ECMO is based on clinical judgment. The prognostic impact of pre-V-A-ECMO arterial lactate level in these critically ill patients has been herein evaluated. Methods: A systematic review was conducted to identify studies on postcardiotomy VA-ECMO for the present individual patient data meta-analysis. Results: Overall, 1269 patients selected from 10 studies were included in this analysis. Arterial lactate level at V-A-ECMO initiation was increased in patients who died during the index hospitalization compared to those who survived (9.3 vs 6.6 mmol/L, p 0.0001). Accordingly, in hospital mortality increased along quintiles of pre-V-A-ECMO arterial lactate level (quintiles: 1, 54.9%; 2, 54.9%; 3, 67.3%; 4, 74.2%; 5, 82.2%, p 0.0001). The best cut-off for arterial lactate was 6.8 mmol/L (in-hospital mortality, 76.7% vs. 55.7%, p 0.0001). Multivariable multilevel mixed-effect logistic regression model including arterial lactate level significantly increased the area under the receiver operating characteristics curve (0.731, 95% CI 0.702-0.760 vs 0.679, 95% CI 0.648-0.711, DeLong test p 0.0001). Classification and regression tree analysis showed the in-hospital mortality was 85.2% in patients aged more than 70 years with pre-V-A-ECMO arterial lactate level ≥6.8 mmol/L. Conclusions: Among patients requiring postcardiotomy V-A-ECMO, hyperlactatemia was associated with a marked increase of in-hospital mortality. Arterial lactate may be useful in guiding the decision-making process and the timing of initiation of postcardiotomy V-A-ECMO.
Med Sci Monit. 2023 Apr 7:29:e939429. Comparison of Radifocus versus Silverway Guidewires for Percutaneous Radial Angiography Following Failed Use of a J-Tip Guidewire
Deborah M F van den Buijs, Ella M Poels, Bert Ferdinande, Daan Cottens, Mathias Vrolix, Jeroen Dauw, Jo Dens, Koen Ameloot
PMID: 37025045 Abstract BACKGROUND During transradial coronary angiography, when conventional J-tip wires fail to deliver catheters to the aortic root due to anatomical obstacles, additional hydrophilic wires, such as Radifocus (Terumo) or Silverway (Asahi), are used. We recently showed that the Silverway guidewire was effective at delivering the catheter to the aortic root. In this study, we aimed to compare the efficacy and safety of Radifocus and Silverway guidewires in 100 patients after failed use of the J-tip guidewire. MATERIAL AND METHODS After patients had a failure of a conventional J-tip wire to reach the aortic root, 100 patients were 1:1 randomized to either the Silverway or Radifocus wire. All patients with failure of the J-tip wire were eligible. The primary endpoint was the time between wire entry in the catheter and successful delivery of the catheter to the aortic root. Secondary endpoints included change of access site, number of complications, and questionnaires on subjective wire assessments by the performing interventional cardiologist. RESULTS The primary endpoint was significantly shorter in patients randomized to the Silverway arm (median 30 s [21-39] vs 48 s [36-66]; P0.001)). The percentage of patients with change of access site was not different between the groups (2 vs 2, not significant). Only 1 minor complication (2%) occurred, in the Radifocus group. Questionnaires revealed that torque control, crossing, and support were all significantly better with the Silverway wire (P0.001). CONCLUSIONS Silverway showed superior torque control, resulting in faster catheter delivery to the aortic root when compared with the Radifocus guidewire.
Clin Orthop Relat Res. 2023 Apr 1;481(4):837-838. Letter to the Editor: Editor's Spotlight/Take 5: Has Arthroscopic Meniscectomy Use Changed in Response to the Evidence? A Large-database Study From Spain Johan Bellemans
PMID: 36651828
No abstract available
Pain Res Manag. 2023 Apr 14:2023:7708982. Considerations on the Obstacles That Lead to Slow Recruitment in a Pain Management Clinical Trial: Experiences from the Belgian PELICAN (PrEgabalin Lidocaine Capsaicin Neuropathic Pain) Pragmatic Study
Guy H Hans, Dima Almeshal, Lotte Vanlommel, Ella Roelant, Iris Verhaegen, Elke Smits, Koen Van Boxem, Robert Fontaine, The Pelican Investigators Team
PMID: 37089721 Abstract Background: A qualitative evaluation study of the prematurely terminated PrEgabalin Lidocaine Capsaicin Neuropathic Pain (PELICAN) study was performed. The PELICAN study aimed to examine pain management for localized neuropathic pain (LNP), as epidemiological figures have shown a high percentage of LNP patients in Belgium. The study compared systemic and topical medications according to pain relief, adverse effects, and several measures of quality of life. Objective: Achieving better study patient recruitment through qualitative research. To investigate and determine the causes of the observed recruitment problems in the PELICAN study, pain centers involved in the study as well as nonrecruiting pain centers were included. Furthermore, it aimed to highlight the positive and negative lessons learned from the conducted study and the number of obstacles the team had to overcome. Methods: A qualitative study, using a mixed methods approach, was performed. Multiple pain centers in Belgium completed an online survey, after which a structured interview was conducted to elaborate the responses in more detail. The broad topics of these meetings were feedback about the study, reviewing survey answers, and actions undertaken to enhance recruitment. Results: Different factors contributed to the low recruitment rate in the PELICAN study, such as limited and late referral from the general practitioners to the Belgian pain centers, insufficient internal referrals from nonpain specialists, lack of specific expertise on LNP in some centers, scarcity of staff, limited reimbursement to administer complex analgesic schemes, overestimation of the patient population, and the reluctance of patients to participate in pain research. Additionally, shortcomings in the implemented study design and the need for more logistical investments were identified. Conclusion: The findings of the qualitative study demonstrate the need for further, more varied LNP research in Belgium, not limited to pharmacological studies. It also sheds important light on the recruitment obstacles that may be faced during these studies. Future studies could support this research by offering better proposals for feasibility and recruitment, for instance, by designing and conducting a compelling pilot study or applying social media during the recruitment phase. Clinical Trials.
Clin Kidney J. 2023 Apr 6;16(6):905-908. Testing the functional reserve of the kidney before hematopoietic stem cell transplantation: doubt remains
Bart De Moor, Ben Sprangers
PMID: 37261006 Abstract
Acute kidney injury is a common and important complication following hematopoietic stem cell transplantation. In the nephrology community, acute kidney injury is no longer viewed as a simple temporary and potentially reversible decline in kidney clearance as acute kidney injury imposes a risk for immediate and future complications. Therefore, stratifying patients for the risk of acute kidney injury following stem cell transplantation would be very helpful to optimize peri-stem cell transplant management and could potentially improve outcomes in this patient population. In the current issue of CKJ, Mancianti et al. report on the testing of the kidney's functional reserve in patients planned for stem cell transplantation and demonstrate that stem cell transplant candidates with a preserved kidney response on a protein load had a higher chance of full kidney recovery after an episode of acute kidney injury. In this editorial, we discuss the kidney's functional reserve test and its limitations.
Acta Neurol Belg. 2024 Apr;124(2):523-531. The effect of anesthesia on hemodynamics and outcome of patients undergoing thrombectomy after acute ischemic stroke: a retrospective analysis Sofie Ordies, Thomas De Brauwer, Tom De Beule, Sven Van Poucke, Kim Bekelaar, Ben Van Bylen, Dieter Mesotten; Stroke Consortium
PMID: 37857938 Abstract Background: Anesthesia during thrombectomy remains a matter of debate. We retrospectively investigated the influence of intraprocedural blood pressure and type of anaesthetic agent on 3-month functional outcome and mortality in stroke patients undergoing mechanical thrombectomy under general anesthesia in a single center study. Methods: All patients suffering from stroke who presented between January 2019 and July 2021 at Ziekenhuis Oost-Limburg Genk, Belgium and who received thrombectomy were included. Patient's characteristics and outcome data had been collected for benchmarking. Detailed perioperative data were exported from the electronic anesthesia records and clinically validated. Patients were stratified by peri-operative presence of hypotension (MAP 65 mmHg at any time point) versus no-hypotension (MAP ≥ 65 mmHg). Results: All 98 patients received mechanical thrombectomy under general anesthesia. Thirty-six percent (n = 35) was hypotensive peri-operatively at any time point. Proportion of sevoflurane use was higher in non-hypotensive patients compared to hypotensive patients (73% (n = 45) vs. 51% (n = 18), p = 0.04). Peri-operative use of vasopressors was higher in the hypotensive group compared to non-hypotensive (88% (n = 30) vs. 63% (n = 39), p = 0.008). Proportion of patients with good functional outcome at 3 months (mRS 0-2) was higher in non-hypotensive patients compared to hypotensive patients 44% (n = 27) vs. 24% (n = 8), p 0.05. 90-day mortality was lower in non-hypotensive patients compared to hypotensive patients 21% (n = 13) vs. 43% (n = 15), (p = 0.02). Conclusion: Patients who are hypotensive at any given time during thrombectomy under general anesthesia may have worse neurological outcome compared to non-hypotensive patients. The best anaesthetic management for mechanical thrombectomy needs to be clarified prospectively in large multicenter studies.
Diagn Pathol. 2023 Apr 25;18(1):52. Breast implant associated EBV-positive Diffuse Large B-cell lymphoma: an underrecognized entity?
Johanna Vets, Lukas Marcelis, Charlotte Schepers, Yaliva Dorreman, Sanne Verbeek, Lieve Vanwalleghem, Katrien Gieraerts, Liesbeth Meylaerts, Jan Lesaffer, Helena Devos, Natalie Put, Sylvia Snauwaert, Pascale De Paepe, Thomas Tousseyn
PMID: 37098615 Abstract
Breast-implant associated (BIA) lymphoma is an infrequent type of cancer occurring in the fluid and fibrous capsule around a textured breast implant. Recently, both the 2022 WHO 5th edition classification of Haematological tumours (WHO HAEM5) and 2022 International Consensus Classification of Mature Lymphoid Neoplasms (22ICC), recognized breast implant-associated Anaplastic Large Cell Lymphoma (BIA-ALCL) as a definitive entity, defined as a mature CD30-positive T-cell lymphoma, confined by a fibrous capsule, in a breast implant setting. Only few B-cell lymphomas have been reported in the literature to be associated with breast implants. Here we report two EBV-positive Diffuse Large B-cell lymphomas (EBV + DLBCL) in relation to a breast implant, both expressing CD30 as well as EBV latency type 3. Both lesions were considered as DLBCL associated with chronic inflammation (CI-DLBCL), but one presented as a 7 cm solid mass, while the other presented as a fibrin-associated DLBCL (FA-DLBCL) in an HIV patient. Clinically, both are in complete remission 6 months or longer after capsulectomy and graft removal, without additional chemotherapy. Such cases, characterized by large CD30-positive cells, can easily be misdiagnosed as BIA-ALCL if the cell of origin is not further established. Therefore, a diagnostic panel including lineage-specific B-and T-cell markers and EBER in situ hybridization is essential to recognize this rare entity, to understand lymphomagenesis, to predict outcome and to define clinical approach.
Int Orthop. 2023 Apr;47(4):1013-1020. Anatomical variation in humeri: gender and side comparison using statistical shape modelling Jan Dauwe, Sanne Vancleef, Stijn De Bondt, Stefaan Nijs
PMID: 36763125 Abstract Purpose: The surgical management of proximal humeral fractures remains challenging. Anatomical reduction of the fracture has been reported as the keystone for a sufficient surgical fixation and successful outcome. However, mostly there is no example of its premorbid state. Literature suggests that the mirrored contralateral side can be used as a reconstruction template. But is this a correct technique to use? The purpose of this study is to define anatomical variation between humeri based on gender and side comparison. Methods: Two different statistical shape models of the humerus were created and their modes of variation were described. One model contained 110 unpaired humeri. The other model consisted of 65 left and corresponding right humeri. Results: The compactness of the statistical shape model containing 110 humeri showed that two principal components explain more than 95% of the variation and the generalization showed that a random humerus can be described with an accuracy of 0.39 mm. For only three parameters, statistically significant differences were observed between left and right. However, comparing the mean of the different metrics on the humeri of men and women, almost all were significant. Conclusion: Since there were only small differences between left and right humeri, using the mirrored contralateral side as a reconstruction template for fracture reduction can be defended. The variable anatomy between men and women could explain why locking plates not always fit to the bon
Eur Rev Med Pharmacol Sci. 2023 Apr;27(8):3784-3792. The human carotid atherosclerotic plaque: an observational review of histological scoring systems
C Gerosa, G Cerrone, J S Suri, V Aimola, F Cau, P Coni, M Piras, R Cau, A Balestrieri, A Scano, G Orrù, P Van Eyken, G La Nasa, F Coghe, M Castagnola, Y Gibo, D Fanni, L Saba
PMID: 37140327 Abstract Objective: The atherosclerotic plaque is a complex dynamic pathological lesion of the arterial wall, characterized by multiple elementary lesions of different diagnostic and prognostic significance. Fibrous cap thickness, lipid necrotic core dimension, inflammation, intra-plaque hemorrhage (IPH), plaque neovascularization and endothelial dysfunction (erosions) are generally considered the most relevant morphological details of plaque morphology. In this review, the most relevant features able to discriminate between stable and vulnerable plaques at histological level are discussed.
Subjects and methods: Retrospectively, we have evaluated the laboratory results from one hundred old histological samples from patients treated with carotid endarterectomy. These results were analyzed to assess elementary lesions that characterize stable and unstable plaques. Results: A thin fibrous cap (65 micron), loss of smooth muscle cells, collagen depletion, a large lipid-rich necrotic core, infiltrating macrophages, IPH and intra-plaque vascularization are identified as the most important risk factors associated with plaque rupture. Conclusions: Immunohistochemistry for smooth muscle actin (smooth muscle cell marker) and for CD68 (marker of monocytes/macrophages) and glycophorin (marker of red blood cells) are suggested as useful tools for an in deep characterization of any carotid plaque and for distinguishing plaque phenotypes at histology. Since patients with a carotid vulnerable plaque are at higher risk of developing vulnerable plaques in other arteries as well, the definition of the vulnerability index is underlined, in order to stratify patients at higher risk for undergoing cardiovascular events.
Pain Pract. 2024 Apr;24(4):686-687. Update of evidence-based interventional pain medicine according to clinical diagnoses: Cervical radicular pain response to Helm et al Laurens Peene, Steven P Cohen, Brigitte Brouwer, James Rathmell, Andre Wolff, Koen Van Boxem, Jan Van Zundert
PMID: 38099416
EClinicalMedicine. 2023 Apr 17:59:101940. Safety and performance of the third-generation drug-eluting resorbable coronary magnesium scaffold system in the treatment of subjects with de novo coronary artery lesions: 6-month results of the prospective, multicenter BIOMAG-I first-in-human study
Michael Haude, Adrian Wlodarczak, René J van der Schaaf, Jan Torzewski, Bert Ferdinande, Javier Escaned, Juan F Iglesias, Johan Bennett, Gabor Toth, Michael Joner, Ralph Toelg, Marcus Wiemer, Göran Olivecrona, Paul Vermeersch, Hector M Garcia-Garcia, Ron Waksman
PMID: 37113674 Abstract Background: A third-generation coronary drug-eluting resorbable magnesium scaffold (DREAMS 3G) was developed to enhance the performance of previous scaffold generations and achieve angiographic outcomes comparable to those of contemporary drug-eluting stents. Methods: This prospective, multicenter, non-randomized, first-in-human study was conducted at 14 centers in Europe. Eligible patients had stable or unstable angina, documented silent ischemia, or non-ST-elevation myocardial infarction, and a maximum of two single de novo lesions in two separate coronary arteries with a reference vessel diameter between 2.5 mm and 4.2 mm. Clinical follow-up was scheduled at one, six and 12 months and annually thereafter until five years. Invasive imaging assessments were scheduled six and 12 months postoperatively. The primary endpoint was angiographic in-scaffold late lumen loss at six months. This trial was registered at ClinicalTrials.gov (NCT04157153). Findings: Between April 2020 and February 2022, 116 patients with 117 coronary artery lesions were enrolled. At six months, in-scaffold late lumen loss was 0.21 mm (SD 0.31). Intravascular ultrasound assessment showed preservation of the scaffold area (mean 7.59 mm2 [SD 2.21] post-procedure vs 6.96 mm2 [SD 2.48]) at six months) with a low mean neointimal area (0.02 mm2 [SD 0.10]). Optical coherence tomography revealed that struts were embedded in the vessel wall and were already hardly discernible at six months. Target lesion failure occurred in one (0.9%) patient; a clinically driven target lesion revascularization was performed on post-procedure day 166. No definite or probable scaffold thrombosis or myocardial infarction was observed. Interpretation: These findings show that the implantation of DREAMS 3G in de novo coronary lesions is associated with favorable safety and performance outcomes, comparable to contemporary drug-eluting stents.
Pain Pract. 2024 Apr;24(4):627-646. 5. Sacroiliac joint pain
Karolina Szadek, Steven P Cohen, Javier de Andrès Ares, Monique Steegers, Jan Van Zundert, Jan Willem Kallewaard
PMID: 38155419 Abstract Introduction: Sacroiliac (SI) joint pain is defined as pain localized in the anatomical region of the SI joint. The reported prevalence of SI joint pain among patients with mechanical low back pain varies between 15% and 30%. Methods: In this narrative review, the literature on the diagnosis and treatment of SI joint pain was updated and summarized. Results: Patient's history provides clues on the source of pain. The specificity and sensitivity of provocative maneuvers are relatively high when three or more tests are positive, though recent studies have questioned the predictive value of single or even batteries of provocative tests. Medical imaging is indicated only to rule out red flags for potentially serious conditions. The diagnostic value of SI joint infiltration with local anesthetic remains controversial due to the potential for false-positive and false-negative results. Treatment of SI joint pain ideally consists of a multidisciplinary approach that includes conservative measures as first-line therapies (eg, pharmacological treatment, cognitive-behavioral therapy, manual medicine, exercise therapy and rehabilitation treatment, and if necessary, psychological support). Intra- and extra-articular corticosteroid injections have been documented to produce pain relief for over 3 months in some people. Radiofrequency ablation (RFA) of the L5 dorsal ramus and S1-3 (or 4) lateral branches has been shown to be efficacious in numerous studies, with extensive lesioning strategies (eg, cooled RFA) demonstrating the strongest evidence. The reported rate of complications for SI joint treatments is low. Conclusions: SI joint pain should ideally be managed in a multidisciplinary and multimodal manner. When conservative treatment fails, corticosteroid injections and radiofrequency treatment can be considered.
Eur J Cardiovasc Nurs. 2023 May 25;22(4):412-424. Patient motivation and adherence to an on-demand app-based heart rate and rhythm monitoring for atrial fibrillation management: data from the TeleCheck-AF project
Monika Gawałko, Astrid N L Hermans, Rachel M J van der Velden, Konstanze Betz, Dominique Vm Verhaert, Henrike A K Hillmann, Daniel Scherr, Julia Meier, Arian Sultan, Daniel Steven, Elena Terentieva, Ron Pisters, Martin Hemels, Leonard Voorhout, Piotr Lodziński, Bartosz Krzowski, Dhiraj Gupta, Nikola Kozhuharov, Laurent Pison, Henri Gruwez, Lien Desteghe, Hein Heidbuchel, Stijn Evens, Emma Svennberg, Tom de Potter, Kevin Vernooy, Nikki A Ha Pluymaekers, Martin Manninger, David Duncker, Afzal Sohaib, Dominik Linz, Jeroen M Hendriks
PMID: 35932189 Abstract Aims: The aim of this TeleCheck-AF sub-analysis was to evaluate motivation and adherence to on-demand heart rate/rhythm monitoring app in patients with atrial fibrillation (AF). Methods and results: Patients were instructed to perform 60 s app-based heart rate/rhythm recordings 3 times daily and in case of symptoms for 7 consecutive days prior to teleconsultation. Motivation was defined as number of days in which the expected number of measurements (≥3/day) were performed per number of days over the entire prescription period. Adherence was defined as number of performed measurements per number of expected measurements over the entire prescription period.Data from 990 consecutive patients with diagnosed AF [median age 64 (57-71) years, 39% female] from 10 centres were analyzed. Patients with both optimal motivation (100%) and adherence (≥100%) constituted 28% of the study population and had a lower percentage of recordings in sinus rhythm [90 (53-100%) vs. 100 (64-100%), P 0.001] compared with others. Older age and absence of diabetes were predictors of both optimal motivation and adherence [odds ratio (OR) 1.02, 95% coincidence interval (95% CI): 1.01-1.04, P 0.001 and OR: 0.49, 95% CI: 0.28-0.86, P = 0.013, respectively]. Patients with 100% motivation also had ≥100% adherence. Independent predictors for optimal adherence alone were older age (OR: 1.02, 95% CI: 1.00-1.04, P = 0.014), female sex (OR: 1.70, 95% CI: 1.29-2.23, P 0.001), previous AF ablation (OR: 1.35, 95% CI: 1.03-1.07, P = 0.028). Conclusion: In the TeleCheck-AF project, more than one-fourth of patients had optimal motivation and adherence to app-based heart rate/rhythm monitoring. Older age and absence of diabetes were predictors of optimal motivation/adherence.
J Vasc Access. 2023 May 10:11297298231174932. Study protocol of a prospective single-arm multicenter clinical study to assess the safety and performance of the aXess hemodialysis graft: The pivotal study
An S De Vriese, Annick D'Haeninck, Artur Mendes, Augusto Ministro, Dainis Krievins, David Kingsmore, Gaspar Mestres, Gonzalo Villanueva, Hugo Rodrigues, Jakub Turek, Maciej Zieliński, Jan De Letter, Andreia Coelho, Luís Alvarenga Loureiro, Matteo Tozzi, Mirko Menegolo, Palma Fariñas Alija, Panagiotis G Theodoridis, Paul Gibbs, Reze Ebrahimi, Sigi Nauwelaers, Stavros K Kakkos, Vladimir Matoussevitch, Frans Moll, Mauro Gargiulo
PMID: 37165650 Abstract Background: Arteriovenous grafts (AVGs) are used for patients deemed unsuitable for the creation of an autogenous arteriovenous fistula (AVF) or unable to await maturation of the AVF before starting hemodialysis. However, AVGs are prone to infection and thrombosis resulting in low long-term patency rates. The novel aXess Hemodialysis Graft consists of porous polymeric biomaterial allowing the infiltration by cells and the growth of neotissue, while the graft itself is gradually absorbed, ultimately resulting in a fully functional natural blood vessel. The Pivotal Study will examine the long-term effectiveness and safety of the aXess Hemodialysis Graft. Methods: The Pivotal Study is a prospective, single-arm, multicenter study that will be conducted in 110 subjects with end-stage renal disease who are not deemed suitable for the creation of an autogenous vascular access. The primary efficacy endpoint will be the primary patency rate at 6 months. The primary safety endpoint will be the freedom from device-related serious adverse events at 6 months. The secondary endpoints will include the procedural success rate, time to first cannulation, patency rates, the rate of access-related interventions to maintain patency, the freedom from device-related serious adverse events and the rate of access site infections. Patients will be followed for 60 months. An exploratory Health Economic and Outcomes Research sub-study will determine potential additional benefits of the aXess graft to patients, health care institutions, and reimbursement programs. Discussion: The Pivotal study will examine the long-term performance and safety of the aXess Hemodialysis Graft and compare the outcome measures with historical data obtained with other graft types and autogenous AVFs. Potential advantages may include superior long-term patency rates and lower infection rates versus currently available AVGs and a shorter time to first cannulation compared to an autologous AVF. As such, the aXess Hemodialysis Graft may fulfill an unmet clinical need in the field of hemodialysis access.
J Am Coll Cardiol. 2023 May 23;81(20):2013-2024. Natriuretic Response to Acetazolamide in Patients With Acute Heart Failure and Volume Overload Frederik H Verbrugge, Pieter Martens, Jeroen Dauw, Petra Nijst, Evelyne Meekers, Silvio Nunes Augusto Jr, Jozine M Ter Maaten, Kevin Damman, Gerasimos Filippatos, Johan Lassus, Alexandre Mebazaa, Frank Ruschitzka, Matthias Dupont, Wilfried Mullens
PMID: 37197845 Abstract Background: Acetazolamide facilitates decongestion in acute decompensated heart failure (ADHF). Objectives: This study sought to investigate the effect of acetazolamide on natriuresis in ADHF and its relationship with outcomes. Methods: Patients from the ADVOR (Acetazolamide in Decompensated Heart Failure with Volume Overload) trial with complete data on urine output and urine sodium concentration (UNa) were analyzed. Predictors of natriuresis and its relationship with the main trial endpoints were evaluated. Results: This analysis included 462 of 519 patients (89%) from the ADVOR trial. During 2 days after randomization, UNa was 92 ± 25 mmol/L on average, and total natriuresis was 425 ± 234 mmol. Allocation to acetazolamide strongly and independently predicted natriuresis with a 16 mmol/L (19%) increase in UNa and 115 mmol (32%) greater total natriuresis. Higher systolic blood pressure, better renal function, higher serum sodium levels, and male sex also independently predicted both a higher UNa and greater total natriuresis. A stronger natriuretic response was associated with faster and more complete relief of signs of volume overload, and this effect was already significant on the first morning of assessment (P = 0.022). A significant interaction was observed between the effect of allocation to acetazolamide and UNa on decongestion (P = 0.007). Stronger natriuresis with better decongestion translated into a shorter hospital stay (P 0.001). After multivariable adjustments, every 10 mmol/L UNa increase was independently associated with a lower risk of all-cause death or heart failure readmission (HR: 0.92; 95% CI: 0.85-0.99). Conclusions: Increased natriuresis is strongly related to successful decongestion with acetazolamide in ADHF. UNa may be an attractive measure of effective decongestion for future trials. (Acetazolamide in Decompensated Heart Failure with Volume Overload [ADVOR]; NCT03505788).
Neurochirurgie. 2023 May;69(3):101420. Training and teaching of vagus nerve stimulation surgery: Worldwide survey and future perspectives
M Zanello, M Dibué, E Cornips, A Roux, A McGonigal, J Pallud, R Carron
PMID: 36775121 Abstract Objective: Vagus nerve stimulation (VNS) therapy has been used for more than two decades to treat drug resistant epilepsy and depression and most recently received FDA approval for stroke rehabilitation. Expanding indications will renew the interest in the technique and increase the number of surgeons to be trained. The aim of this study was to survey surgeons with substantial expertise on optimal teaching and training approaches. Methods: Anonymous forms comprising 16 questions were sent by e-mail to surgeons with substantial expertise. Statistical analyses were used to compare the answers of the most experienced surgeons (>5 years) with the less experienced ones (5 years). Results: Fully-completed forms were collected from 57 experts from 20 countries. The placement of the helical coils was deemed to be the most difficult step by 36 (63.2%) experts, and the use of optical magnification during this step was deemed necessary by 39 (68.4%) experts. Vocal cord palsy should be largely avoidable with proper surgical technique according to 44 (77.2%) experts. The teaching tool considered the most useful was mentoring (38, 66.7%). The future of VNS surgery teaching was deemed to be in anatomical workshops (29, 50.9%) and surgical simulation (26, 45.6%). Overall, answers did not vary significantly according to experience. Conclusions: VNS surgery should be mastered by actively participating in dedicated practical training courses and by individual mentoring during actual surgery, which is still the best way to learn. This study highlights the need for a formal training course and possible specific accreditation.
Eur J Pain. 2023 May;27(5):651-652. Comment on 'Long-term effectiveness of epidural steroid injections after new episodes of low back pain in older adults' by Curatolo et al Koen Van Boxem, Jan Willem Kallewaard, Laurens Peene, Jan Van Zundert
PMID: 36755430
Front Cardiovasc Med. 2023 May 11:10:1097468. Individualized QT interval (QTi) is a powerful diagnostic tool in long QT syndrome: results from a large validation study
Tomas Robyns, Dieter Nuyens, Bert Vandenberk, Peter Haemers, Jeroen Breckpot, Christophe Garweg, Joris Ector, Rik Willems
PMID: 37252121 Abstract Aims: Diagnosis of Long QT syndrome (LQTS) is based on prolongation of the QT interval corrected for heart rate (QTc) on surface ECG and genotyping. However, up to 25% of genotype positive patients have a normal QTc interval. We recently showed that individualized QT interval (QTi) derived from 24 h holter data and defined as the QT value at the intersection of an RR interval of 1,000 ms with the linear regression line fitted through QT-RR data points of each individual patient was superior over QTc to predict mutation status in LQTS families. This study aimed to confirm the diagnostic value of QTi, fine-tune its cut-off value and evaluate intra-individual variability in patients with LQTS. Methods: From the Telemetric and Holter ECG Warehouse, 201 recordings from control individuals and 393 recordings from 254 LQTS patients were analysed. Cut-off values were obtained from ROC curves and validated against an in house LQTS and control cohort. Results: ROC curves indicated very good discrimination between controls and LQTS patients with QTi, both in females (AUC 0.96) and males (AUC 0.97). Using a gender dependent cut-off of 445 ms in females and 430 ms in males, a sensitivity of 88% and specificity of 96% were achieved, which was confirmed in the validation cohort. No significant intra-individual variability in QTi was observed in 76 LQTS patients for whom at least two holter recordings were available (483 ± 36 ms vs. 489 ± 42 ms, p = 0.11). Conclusions: This study confirms our initial findings and supports the use of QTi in the evaluation of LQTS families. Using the novel gender dependent cut-off values, a high diagnostic accuracy was achieved.
Front Med (Lausanne). 2023 May 10:9:1049459. Corrigendum: Nailfold video capillaroscopy in pregnant women with and without cardiovascular risk factors Kristof Thevissen, Merve Demir, Jerome Cornette, Wilfried Gyselaers
PMID: 37180731
Eur J Orthop Surg Traumatol. 2023 May;33(4):1075-1082. Combined lateral extra-articular tenodesis and anterior cruciate ligament reconstruction: risk of osteoarthritis
Jonas Declercq, Margot Schuurmans, Lore Tack, Cato Verhelst, Jan Truijen
PMID: 35362778 Abstract Purpose: Lateral extra-articular tenodesis (LET) procedure, combined with an intra-articular reconstruction of the anterior cruciate ligament (ACL), is used to reduce rotational laxity and the risk of graft failure. However, concern of overtightening of the lateral compartment and subsequent osteoarthritis remains. The aim of this study is to evaluate the degenerative changes in the lateral compartment and to compare the clinical and radiographical results between two LET techniques. Methods: Eighty-three patients (86 knees) were retrospectively reviewed at a mean of 67.7 months (range 49-85 months). Forty-two knees had an ACL reconstruction combined with a LET procedure according to the modified Lemaire technique and 44 knees according to the modified Coker-Arnold technique. IKDC, Lysholm, Tegner and VAS scores were used. Osteoarthritis was radiographically evaluated by the Kellgren-Lawrence classification. Results: There were 12 patients (28.6%) in the modified Lemaire subgroup and 13 patients (29.5%) in the modified Coker-Arnold subgroup that had doubtful or mild radiologic signs of osteoarthritis. No patients had moderate or severe signs at final follow-up. There was no significant difference in radiological signs of osteoarthritis. In the modified Lemaire subgroup, we report a mean IKDC of 86.31 (± 13.794), a mean Lysholm of 87.83 (± 12.802) and a mean Tegner of 5.38 (± 2.556). In the modified Coker-Arnold subgroup, a mean IKDC of 87.27 (± 11.653), a mean Lysholm of 91.89 (± 8.035) and a mean Tegner of 5.16 (± 2.420) were reported. There were no statistical significant differences between both techniques. In eight patients, a complication was identified, 3 of which had a failure of the ACL reconstruction. Conclusions: The chosen LET-technique seems to have minimal effect on both the clinical and the radiographic results. The LET is a safe procedure, and it does not increase the risk of osteoarthritis in the lateral compartment.
Appl Neuropsychol Adult. 2023 May 21:1-17. The sustained attention to response task: Validation of a non-numerical parallel form
Armien Lanssens, Nora Tuts, Lies Welkenhuyzen, Hella Thielen, Celine R Gillebert
PMID: 37210673 Abstract
Many activities in daily life rely on the ability to continuously keep attention on task requirements. Patients with acquired brain injury often suffer from deficits in sustained attention that impact quality of life and complicate rehabilitation. The sustained attention to response task (SART) is a commonly used go/no-go task in the assessment of sustained attention. However, its feasibility for patients with acquired brain injury could be questioned considering deficits in alphanumerical processing following brain damage. We investigated whether a SART with sinusoidal gratings instead of digits can be used to assess sustained attention. The Gratings SART and Digits SART were administered in a random and fixed sequence to 48 cognitively healthy participants. Performance of the neurotypical individuals on the random and fixed Gratings SART was only moderately different from and correlated with performance on the random and fixed Digits SART. As a proof of concept, the SARTs were also administered to 11 cases with acquired brain injury. Performance in the random and fixed variants of both the Gratings SART and Digits SART was sensitive to cognitive impairments of cases with acquired brain injury. In conclusion, the SART with sinusoidal gratings holds promise as a tool to (re-)assess sustained attention in clinical practice. Further research is critical to investigate whether its performance accurately predicts sustained attention in daily life since we failed to find a significant correlation between performance on any of the SARTs and a self-reported measure of sustained attention.
Transplantation. 2023 May 1;107(5):1056-1068. Kidney Transplantation in Patients With Monoclonal Gammopathy of Renal Significance Ben Sprangers, Ute Hegenbart, Jack F M Wetzels
PMID: 36584374 Abstract
Monoclonal gammopathy of renal significance (MGRS) defines disorders characterized by direct or indirect kidney injury caused by a monoclonal immunoglobulin produced by a B-cell or plasma-cell clone that does not meet current hematologic criteria for therapy. MGRS-associated kidney diseases are diverse and can result in the development of end-stage kidney disease. The current paradigm states that the underlying hematologic condition should be treated and in deep remission before kidney transplantation can be performed because recurrence has been reported for all MGRS-associated kidney diseases. However, we suggest that decisions regarding kidney transplantation in MGRS patients should be individualized considering many factors such as the subtype of MGRS-associated kidney disease, patient age and comorbidity, presence and risk of extrarenal complications, estimated waiting time, the availability of a living kidney donor, and previous hematological treatment and response. Thus, kidney transplantation should be considered even in treatment-naive patients, with hematological treatment initiated after successful kidney transplantation.
J Clin Med. 2023 May 26;12(11):3683. Perinatal Outcome of Singletons Born after Using a Simplified Low-Cost IVF Culture System and All Singletons Born in Flanders (Belgium) between 2012 and 2020 Willem Ombelet, Régine Goemaes, Elizaveta Fomenko, Rudi Campo
PMID: 37297877 Abstract Background: We developed a simplified IVF culture system (SCS) which has proven to be effective and safe in a selected IVF cohort.
Methods: Preterm birth (PTB) and low birth weight (LBW) of 175 singletons born after using the SCS, 104 after fresh embryo transfer (ET), and 71 after frozen embryo transfer, were compared with all singletons born in Flanders between 2012 and 2020 conceived after natural conception, ovarian stimulation (OS), and assisted reproduction (IVF/ICSI). Findings: The proportion of preterm (37 weeks) births was significantly higher in the case of IVF or ICSI, followed by hormonal treatment, compared to spontaneous pregnancies. There was no significant difference in PTB between SCS and any of the other groups. Concerning the average birth weight we found no significant difference between singletons born after natural conception and SCS. However, a significant difference in average birth weight was found between SCS singletons and singletons born after IVF, ICSI and hormonal treatment, with a significantly higher birth weight in the SCS group. This difference was also observed in the proportion of babies weighing less than 2500 g, with significantly more LBW babies in the IVF and ICSI group compared to the SCS newborns. Interpretation: Taking into account the small series, PTB and LBW rates in SCS singletons were found to be comparable with singletons born after natural conception. Compared to babies born after ovarian stimulation and IVF/ICSI, SCS singletons had a lower PTB and LBW rates, although the differences were not significant for PTB. Our results confirm previous reports on reassuring perinatal outcomes after using the SCS technology.
Reg Anesth Pain Med. 2023 May;48(5):197-204. Comparison of cooled versus conventional radiofrequency treatment of the genicular nerves for chronic knee pain: a multicenter non-inferiority randomized pilot trial (COCOGEN trial) Thibaut Vanneste, Amy Belba, Jan Willem Kallewaard, Sander M J van Kuijk, Marloes Gelissen, Peter Emans, Johan Bellemans, Kristof Smeets, Chris Terwiel, Koen Van Boxem, Micha Sommer, Jan Van Zundert
PMID: 36653065 Abstract Background: Radiofrequency (RF) treatment of the genicular nerves has the potential to reduce chronic knee pain due to osteoarthritis or persistent postsurgical pain, however, a direct comparison between the two main modalities used, conventional and cooled, is lacking. Methods: This double blind, non-inferiority, pilot, randomized controlled trial compared the effects of cooled and conventional RF in chronic knee pain patients suffering from osteoarthritis or persistent postsurgical pain after total knee arthroplasty. Patients were randomized following a 1:1 rate. The primary outcome was the proportion of patients with ≥50% pain reduction at 3 months postintervention. Other outcomes were knee pain, functionality, quality of life, emotional health, and adverse events up to 6 months postintervention. Conventional RF treatment was tested for non-inferiority to cooled in reducing knee pain at 3 months follow-up. Results: Forty-nine of 70 patients were included, of which 47 completed a 3-month follow-up. The primary outcome was achieved in 4 of 23 patients treated with conventional RF (17%) vs in 8 of 24 with cooled (33%) (p=0,21). Results from the non-inferiority comparison were inconclusive in relation to the non-inferiority margin. There was no statistically significant difference between secondary outcomes. There were no serious adverse events. Conclusions: Both conventional and cooled RF treatment reduced pain in the osteoarthritis and persistent postsurgical pain population. This pilot study did not demonstrate statistically significant differences in the proportion of patients experiencing ≥50% pain reduction between techniques. The non-inferiority analysis was inconclusive. These results warrant further research.
Indian J Surg Oncol. 2023 Jun;14(Suppl 1):209-219. Multi-omics Analysis Classifies Colorectal Cancer into Distinct Methylated Immunogenic and Angiogenic Subtypes Based on Anatomical Laterality
Anu R I, Aastha Vatsyayan, Dileep Damodaran, Ambily Sivadas, Kurt Van der Speeten
PMID: 37359923 Abstract
We employed supervised machine learning algorithms to a cohort of colorectal cancer patients from the NCI to differentiate and classify the heterogenous disease based on anatomical laterality and multi-omics stratification, in a first of its kind. Multi-omics integrative analysis shows distinct clustering of left and right colorectal cancer with disentangled representation of methylome and delineation of transcriptome and genome. We present novel multi-omics findings consistent with augmented hypermethylation of genes in right CRC, epigenomic biomarkers on the right in conjunction with immune-mediated pathway signatures, and lymphocytic invasion which unlocks unique therapeutic avenues. Contrarily, left CRC multi-omics signature is found to be marked by angiogenesis, cadherins, and epithelial-mesenchymal transition (EMT). An integrated multi-omics molecular signature of RNF217-AS1, hsa-miR-10b, and panel of FBX02, FBX06, FBX044, MAD2L2, and MIIP copy number altered genes have been found by the study. Overall survival analysis reveals genomic biomarkers ABCA13 and TTN in 852 LCRC cases, and SOX11 in 170 RCRC cases that predicts a significant survival benefit. Our study exemplifies the translational competence and robustness of machine learning in effective translational bridging of research and clinic.
Acta Orthop Belg. 2023 Jun;89(2):299-306. Patient-specific instrumentation in total knee arthroplasty: a review of the current literature
Wolfgang Schönthaler, Jan Dauwe, Lukas A Holzer
PMID: 37924556 Abstract
Total knee arthroplasty (TKA) is one of the most frequently performed interventions in the field of Orthopaedic surgery. Over the last decades the implantation technique has improved continuously. The majority of patients is satisfied with the clinical outcome of TKA. However in various clinical follow-ups, up to 20% of unsatisfied patients can be observed. Periprosthetic infection and aseptic loosening seem to be the most common reasons for failure. Malalignment has been discussed as a cause of aseptic loosening and often leads to revision surgery. In order to increase the precision of implant positioning and alignment, new technologies such as patient-specific instrumentation (PSI) have been developed. Since the introduction of PSI, multiple clinical studies have been performed analyzing the clinical and radiological outcome of TKA with PSI technique. This review covers the recent literature of PSI in respect to surgical accuracy, clinical outcome, time- and cost-effectiveness
Best Pract Res Clin Anaesthesiol. 2023 Jun;37(2):157-169. Intrathecal drug delivery in the management of chronic pain Jan Van Zundert, Richard Rauck
PMID: 37321764 Abstract
Targeted intrathecal drug delivery (TIDD) has the objective of bringing the drug(s) close to the receptors influencing pain modulation, and thus reducing the dose and the side effects. Intrathecal drug delivery knew its real start with the development of permanent implantation of intrathecal and epidural catheters, combined with internal or external ports, reservoirs, and programmable pumps. TIDD is a valuable treatment for patients with cancer suffering refractory pain. Patients suffering noncancer-related pain should only be considered for TIDD when all other options have been tested, including spinal cord stimulation. Only two drugs are approved by the US Food and Drug Administration for TIDD administration for chronic pain: morphine and ziconotide as monotherapy. In pain management, off-label use of medication and combination therapy is often reported. The specific action of the intrathecal drugs, the efficacy and safety, is described, as well as the modalities for trialing intrathecal drug delivery and the implantation methods.
BMJ Open. 2023 Jun 2;13(6):e071098. Randomised, controlled, open-label pragmatic trial evaluating changes in functional exercise capacity after primary care PU lmonary RE habilitation in patients with long COVID: protocol of the PuRe-COVID trial in Belgium
Tess Volckaerts, Dirk Vissers, Chris Burtin, Xavier Van Meerbeeck, Kevin de Soomer, Ellie Oostveen, Kim Claes, Ella Roelant, Iris Verhaegen, Michiel Thomeer, Maarten Criel, Kirsten Quadflieg, Dries Cops, David Ruttens, Thérèse S Lapperre
PMID: 37270195 Abstract Introduction: Long COVID is a prevalent condition with many multisystemic symptoms, such as fatigue, dyspnoea, muscle weakness, anxiety, depression and sleep difficulties, impacting daily life and (social and physical) functioning. Pulmonary rehabilitation (PR) may improve physical status and symptoms of patients with long COVID, yet the evidence is limited. Therefore, this trial aims to study the effect of primary care PR on exercise capacity, symptoms, physical activity and sleep in patients with long COVID. Methods and analysis: PuRe-COVID is a prospective, pragmatic, open-label, randomised controlled trial. A sample of 134 adult patients with long COVID will be randomised to a 12 week PR programme in primary care, supervised by a physiotherapist or to a control group, following no PR. A 3 month and 6 month follow-up period is foreseen. The primary endpoint will be the change in exercise capacity measured by 6-minute walk distance (6MWD) at 12 weeks, hypothesising a more significant improvement in the PR group. Other parameters, such as pulmonary function tests (including maximal inspiratory pressure/maximal expiratory pressure), patient-reported outcomes (COPD Assessment Test, modified Medical Research Council Dyspnoea Scale, Checklist Individual Strength, post-COVID-19 Functional Status, Nijmegen questionnaire, Hospital Anxiety and Depression Scale, Work Productivity and Activity Impairment Questionnaire and EuroQol-5D-5L), physical activity measured by an activity tracker, hand grip strength and sleep efficiency, are secondary and exploratory outcomes.The recruitment started on 19 April 2022, and 52 patients were included as of 14 December 2022. Ethics and dissemination: Ethical approval was obtained in Belgium from the relevant institutional review boards on 21 February 2022 (Antwerp University Hospital, approval number 2022-3067) and on 1 April 2022 (Ziekenhuis Oost-Limburg in Genk, approval number Z-2022-01). Findings from this randomised controlled trial will be disseminated in peer-reviewed publications and presentations at international scientific meetings.
Am J Obstet Gynecol. 2023 Jun;228(6):613-621. Origins of abnormal placentation: why maternal veins must not be forgotten Wilfried Gyselaers
PMID: 36539026 Abstract
The importance of uterine microvascular adaptations during placentation in pregnancy has been well established for decades. Inadequate dilatation of spiral arteries is associated with gestational complications, such as preeclampsia and/or intrauterine growth restriction. More recently, it has become clear that trophoblast cells invade and adapt decidual veins and lymphatic vessels 1 month before spiral arteries become patent and before intervillous space perfusion starts. Normal intervillous space hemodynamics is characterized by high volume flow at low velocity and pressure in the interseptal compartments surrounding the chorionic villi, hereby facilitating efficient maternal-fetal exchange. In case of shallow decidual vein dilatation, intervillous arterial supply exceeds venous drainage. This will cause congestion in the interseptal compartments with subsequently reduced perfusion and increased pressure. An efficient mechanism to counteract venous congestion and safeguard the viability of the conceptus is by reducing arterial inflow via shallow dilatation of the spiral arteries. This review made the case for intervillous space congestion as an unexplored trigger for inadequate spiral artery dilatation during the placentation process, eventually leading to abnormal systemic circulatory dysfunctions. An abnormal maternal venous function can result from an abnormal maternal immune response to paternal antigens with an imbalanced release of vasoactive mediators or can exist before conception. To get the full picture of abnormal placentation, maternal veins must not be forgotten.
Indian J Surg Oncol. 2023 Jun;14(Suppl 1):109-121. Peritoneal Surface Malignancies Originating From Urachal Carcinoma: Case Reports and Review of the Literature
Paulien Van Breusegem, Geert Verswijvel, Sabine Fransis, Kurt Van der Speeten
PMID: 37359934 Abstract
Urachal carcinoma (UC) is a rare and aggressive tumor arising from the urachal remnants, with the potential for peritoneal dissemination. Patients diagnosed with UC often have a poor prognosis. To date, there is no standardized treatment. Our objective is to present two cases of patients with peritoneal carcinomatosis (PC) secondary to an UC, who were treated with cytoreductive surgery (CRS) and hyperthermic peroperative intraperitoneal chemotherapy (HIPEC). A review of the literature on CRS and HIPEC in UC suggests CRS and HIPEC to be a safe and viable treatment option. Two patients with PC of UC underwent CRS and HIPEC in our institution. All available data were gathered and reported on. A literary search was carried out to find all available cases of patients with PC secondary to UC treated with CRS and HIPEC. Both patients underwent CRS and HIPEC and are currently free of recurrence. Literature research revealed nine other publications adding up to a total of 68 additional cases. CRS and HIPEC can provide satisfactory long-term oncological outcome with acceptable morbidity and mortality rates in patients with PC of urachal origin. It should be considered as a safe and feasible treatment option with curative potential.
Surg Endosc. 2023 Jun;37(6):4396-4402. Pure robotic major hepatectomy with biliary reconstruction for hepatobiliary malignancies: first European results
Mathieu D'Hondt, Dennis A Wicherts
PMID: 36759354 Abstract Background: Combined liver and bile duct resection with biliary reconstruction for hepatobiliary malignancies are defined as highly complex surgical procedures. The robotic platform may overcome some major limitations of conventional laparoscopic surgery for these complex cases but its precise role is however still to be defined. Methods: In our institution, patients requiring major hepatectomy with biliary reconstruction for malignancies were consecutively selected for minimally invasive robotic surgery from September 2020. All surgeries were undertaken using the da Vinci Xi Surgical System® (Intuitive Surgical, Sunnyvale, CA, USA). Intra-operative technique and postoperative outcome were analyzed. Results: A total number of 10 patients (3 males and 7 females, median age 72 years) underwent robotic major hepatectomy and bile duct resection for hepatobiliary malignancies between September 2020 and March 2022. The indication for surgery was perihilar cholangiocarcinoma in 5 of 10 patients. Median operative time was 338 min and median blood loss was 110 mL. Postoperative length of stay was between 3 and 16 days (median: 9 days). There was no postoperative 90-day mortality. Conclusions: A robotic approach for hepatobiliary malignancies requiring combined major hepatectomy and bile duct resection seems feasible and safe in experienced hands.
Indian J Surg Oncol. 2023 Jun;14(Suppl 1):131-143. Extrapelvic Endometriosis Mimicking Peritoneal Surface Malignancy: Case Report and a Review of Literature
Marie Gaillard, Liesbeth Meylaerts, Kim Govaerts
PMID: 37359914 Abstract
Extrapelvic endometriosis is a rare presentation of endometriosis with atypical clinical symptoms. It can mimic peritoneal surface malignancy, as well as some abdominal infectious diseases. A 29-year-old Moroccan woman presented with abdominal pain, progressive abdominal distention, and an intermittent inflammatory syndrome. Imaging revealed multiple, progressively growing abdominal cysts. She had elevated tumor markers CA125 and CA19.9. Despite thorough investigation, several differential diagnoses persisted for a long time. Definitive pathological diagnosis could only be established after debulking surgery. Literature review on malignant and benign conditions causing multicystic abdominal distention is provided. When definitive diagnosis is not established, but suspicion for peritoneal malignancy remains, a debulking procedure can be undertaken. Organ preservation can be pursued whenever benign disease is still considered. In case of malignancy, short-term (curative) debulking procedure with or without hyperthermic intraperitoneal chemotherapy (HIPEC) can be proposed.
Indian J Surg Oncol. 2023 Jun;14(Suppl 1):240-249. Appendiceal Goblet Cell Carcinoma: Role of Cytoreductive Surgery (CRS) and Hyperthermic Intraperitoneal Chemotherapy (HIPEC)
M Gaillard, P Van Eyken, G Verswijvel, K Van der Speeten
PMID: 37359931 Abstract
Goblet cell carcinoma (GCC) encompasses a separate entity in appendiceal neoplasms with mixed glandular and neuro-endocrine pathological features. GCC mostly presents as an acute appendicitis duo to luminal obstruction or as an incidental finding on the surgical appendectomy specimen. In case of tumour perforation or presence of other risk factors, guidelines suggest additional treatment with a completing right hemicolectomy or cytoreductive surgery (CRS) with hyperthermic intraperitoneal chemotherapy (HIPEC). We report the case of a 77-year-old male with symptoms of appendicitis for which an appendectomy was performed. The appendix was ruptured during the procedure. There was an incidental finding of GCC on the pathological specimen. Because of possible tumour soiling, the patient received a prophylactic CRS-HIPEC. A literature review was performed to investigate the potential role for CRS-HIPEC as a curative treatment in patients with GCC. GCC of the appendix is an aggressive type of tumour with a high risk of peritoneal and systemic dissemination. CRS and HIPEC is a treatment option: both in a prophylactic setting and in patients with established peritoneal metastases.
Acta Chir Belg. 2023 Jun;123(3):272-280. Transnasal transsphenoidal pituitary surgery in a large tertiary hospital, a retrospective study
Charlotte Nys, Georges Versyck, Eveleen Buelens, Koen Engelborghs, Erwin Cornips, Heddy Van Leeuwen-Wintjens, Hugo Vankelecom, Frank Weyns, Diederik Peuskens
PMID: 34590931 Abstract Objectives: Pituitary adenomas (PAs), although being small tumours, can have quite an impact on patients' lives causing hormonal and visual disturbances, for which surgery must be performed. As a large peripheral hospital with specialists in pituitary surgery, an assessment of the efficacy and safety of transnasal transsphenoidal pituitary surgery was made. Methods: A retrospective analysis of neurosurgical reports as well as pre and postoperative imaging was made to evaluate the presenting symptoms, tumoural variables, peri-operative morbidity, and long-term outcome. Results: This cohort included 105 patients who were operated for PAs over a 9-year period, with a slight male predominance. Adenomas had a mean maximum diameter of almost 25 mm, with one-third of tumours presenting with a Knosp-grade 3 or 4. As expected, most patients presented with either visual (32.4%) or hormonal (40.0%) disturbances. After surgery, 85.3% had complete resolution of visual deficits, and 97.1% had normalisation of hormonal hypersecretion. Postoperative hormonal insufficiency requiring substitution was observed in 43.1% and was significantly more frequent in males and in non-functioning pituitary adenomas (NFAs). Postoperative cerebrospinal fluid (CSF) leakage was observed in 2.9%, and merely one patient developed meningitis. Tumour recurrence was significantly more frequent in patients with partial resection as compared to complete resection (25.6 vs. 7.9%). Conclusions: This study demonstrates that transnasal transsphenoidal pituitary surgery can be performed safely and effectively in a large non-university hospital, improving visual and/or hormonal disturbances as well as providing long-term tumour control. Patients with larger adenomas are at an increased risk to develop postoperative hypopituitarism.
Eur Heart J Cardiovasc Imaging. 2023 Jun 21;24(7):961-971. The incremental value of multi-organ assessment of congestion using ultrasound in outpatients with heart failure
Nicola Riccardo Pugliese, Pierpaolo Pellicori, Francesco Filidei, Lavinia Del Punta, Nicolò De Biase, Alessio Balletti, Valerio Di Fiore, Alessandro Mengozzi, Stefano Taddei, Luna Gargani, WilfriedMullens, John G F Cleland, Stefano Masi
PMID: 36595324 Abstract Aims: We investigated the prevalence and clinical value of assessing multi-organ congestion by ultrasound in heart failure (HF) outpatients. Methods and results: Ultrasound congestion was defined as inferior vena cava of ≥21 mm, highest tertile of lung B-lines, or discontinuous renal venous flow. Associations with clinical characteristics and prognosis were explored. We enrolled 310 HF patients [median age: 77 years, median NT-proBNP: 1037 ng/L, 51% with a left ventricular ejection fraction (LVEF) 50%], and 101 patients without HF. There were no clinical signs of congestion in 224 (72%) patients with HF, of whom 95 (42%) had at least one sign of congestion by ultrasound (P 0.0001). HF patients with ≥2 ultrasound signs were older, and had greater neurohormonal activation, lower urinary sodium concentration, and larger left atria despite similar LVEF. During a median follow-up of 13 (interquartile range: 6-15) months, 77 patients (19%) died or were hospitalized for HF. HF patients without ultrasound evidence of congestion had a similar outcome to patients without HF [reference; hazard ratio (HR) 1.02, 95% confidence interval (CI) 0.86-1.35], while those with ≥2 ultrasound signs had the worst outcome (HR 26.7, 95% CI 12.4-63.6), even after adjusting for multiple clinical variables and NT-proBNP. Adding multi-organ assessment of congestion by ultrasound to a clinical model, including NT-proBNP, provided a net reclassification improvement of 28% (P = 0.03). Conclusion: Simultaneous assessment of pulmonary, venous, and kidney congestion by ultrasound is feasible, fast, and identifies a high prevalence of sub-clinical congestion associated with poor outcomes.
Eur Heart J. 2023 Jun 25;44(24):2159-2169. Great debate: in patients with decompensated heart failure, acetazolamide in addition to loop diuretics is the first choice Wilfried Mullens, Paul Christian Schulze, Julian Westphal, Jürgen Bogoviku, Johann Bauersachs
PMID: 37207453 Abstract
Graphical abstract
Key points in favour or against the addition of acetazolamide to loop diuretics as the first choice in patients with decompensated heart failure. Abbreviations: AHF, acute heart failure; HCTZ, hydrochlorothiazide; HHF, hospitalization for heart failure; SGLT2i, sodium–glucose cotransporter 2 inhibitor; WRF, worsening renal function.
J Neurointerv Surg. 2023 Jun;15(6):552-557. Aneurysm treatment with the Woven EndoBridge (WEB) device in the combined population of two prospective, multicenter series: 5-year follow-up
Laurent Pierot, Istvan Szikora, Xavier Barreau, Markus Holtmannspoetter, Laurent Spelle, Joachim Klisch, Denis Herbreteau, Vincent Costalat, Jens Fiehler, Anne-Christine Januel, Thomas Liebig, Luc Stockx, Werner Weber, Joachim Berkefeld, Jacques Moret, Andy Molyneux, James Byrne
PMID: 35803731 Abstract Background: Evaluating a new endovascular treatment for intracranial aneurysms must not only demonstrate short-term safety and efficacy, but also evaluate longer-term outcomes (eg, delayed complications, anatomical results, retreatment). The current analysis reports the 5-year clinical and anatomical results of Woven EndoBridge (WEB) treatment in two European combined trial populations (WEBCAST (WEB Clinical Assessment of Intrasaccular Aneurysm Therapy) and WEBCAST-2). Methods: All adverse events occurring between the procedure and 5-year follow-up were independently evaluated by an expert. Aneurysm occlusion was evaluated by an independent core laboratory using a three-grade scale: complete occlusion, neck remnant, and aneurysm remnant. In cases where data were not available at 5-year follow-up, the last observation carry forward (LOCF) method was used. Results: The safety and efficacy populations comprised 100 patients and 95 aneurysms, respectively. No adverse event related to the device occurred after the procedure during the 5-year follow-up period. Mortality at 5 years was 7.0% (7/100 patients) including mortality related to the WEB (0/100, 0.0%), the procedure (1/100, 1.0%), and another condition (6/100, 6.0%). At 5 years, complete aneurysm occlusion was observed in 49/95 (51.6%) aneurysms, neck remnant in 25/95 (26.3%), and aneurysm remnant in 21/95 (22.1%). Retreatment rate at 5 years was 11.6% (11/95 aneurysms). Conclusions: This analysis conducted in a population of patients with wide-neck bifurcation aneurysms confirms WEB's safety profile. Additional evidence demonstrates good stability of aneurysm occlusion with adequate occlusion (complete occlusion or neck remnant) at 5 years in 77.9% of aneurysms with a low retreatment rate (11.6%).
Trials. 2023 Jun 19;24(1):416. The impact of high versus standard enteral protein provision on functional recovery following intensive care admission (PRECISE trial): study protocol for a randomized controlled, quadruple blinded, multicenter, parallel group trial in mechanically ventilated patients
Rob J J van Gassel, Julia L M Bels, Katrien Tartaglia, Bas C T van Bussel, Sander M J van Kuijk, Adam M Deane, Zudin Puthucheary, Peter J M Weijs, Lilian Vloet, Bert Beishuizen, Ashley De Bie Dekker, Vincent Fraipont, Stoffel Lamote, Didier Ledoux, Clarissa Scheeren, Elisabeth De Waele, Arthur R H van Zanten, Dieter Mesotten, Marcel C G van de Poll
PMID: 37337234 Abstract Background: Critically ill patients are subject to severe skeletal muscle wasting during intensive care unit (ICU) stay, resulting in impaired short- and long-term functional outcomes and health-related quality of life. Increased protein provision may improve functional outcomes in ICU patients by attenuating skeletal muscle breakdown. Supporting evidence is limited however and results in great variety in recommended protein targets. Methods: The PRECISe trial is an investigator-initiated, bi-national, multi-center, quadruple-blinded randomized controlled trial with a parallel group design. In 935 patients, we will compare provision of isocaloric enteral nutrition with either a standard or high protein content, providing 1.3 or 2.0 g of protein/kg/day, respectively, when fed on target. All unplanned ICU admissions with initiation of invasive mechanical ventilation within 24 h of admission and an expected stay on ventilator support of at least 3 days are eligible. The study is designed to assess the effect of the intervention on functional recovery at 1, 3, and 6 months following ICU admission, including health-related quality of life, measures of muscle strength, physical function, and mental health. The primary endpoint of the trial is health-related quality of life as measured by the Euro-QoL-5D-5-level questionnaire Health Utility Score. Overall between-group differences will be assessed over the three time points using linear mixed-effects models. Discussion: The PRECISe trial will evaluate the effect of protein on functional recovery including both patient-centered and muscle-related outcomes.
Rev Esp Cardiol (Engl Ed). 2023 Jun;76(6):417-426. A failed catheter ablation of atrial fibrillation is associated with more advanced remodeling and reduced efficacy of further thoracoscopic ablation
Robin Wesselink, Mindy Vroomen, Ingrid Overeinder, Jolien Neefs, Nicoline W E van den Berg, Eva R Meulendijks, Femke R Piersma, Rushd F M Al-Shama, Tim A C de Vries, Tom E Verstraelen, Justin Luermans, Bart Maesen, Carlo de Asmundis, Gian-Battista Chierchia, Mark La Meir, Laurent Pison, Wim Jan P van Boven, Antoine H G Driessen, Joris R de Groot 8-
PMID: 36155846 Abstract Introduction and objectives: Recent observations suggest that patients with a previous failed catheter ablation have an increased risk of atrial fibrillation (AF) recurrence after subsequent thoracoscopic AF ablation. We assessed the risk of AF recurrence in patients with a previous failed catheter ablation undergoing thoracoscopic ablation. Methods: We included patients from 3 medical centers. To correct for potential heterogeneity, we performed propensity matching to compare AF freedom (freedom from any atrial tachyarrhythmia> 30 s during 1-year follow-up). Left atrial appendage tissue was analyzed for collagen distribution. Results: A total of 705 patients were included, and 183 had a previous failed catheter ablation. These patients had fewer risk factors for AF recurrence than ablation naïve controls: smaller indexed left atrial volume (40.9± 12.5 vs 43.0±12.5 mL/m2, P=.048), less congestive heart failure (1.5% vs 8.9%, P=.001), and less persistent AF (52.2% vs 60.3%, P=.067). However, AF history duration was longer in patients with a previous failed catheter ablation (6.5 [4-10.5] vs 4 [2-8] years; P.001). In propensity matched analysis, patients with a failed catheter ablation were at a 68% higher AF recurrence risk (OR, 1.68; 95%CI, 1.20-2.15; P=.034). AF freedom was 61.1% in patients with a previous failed catheter ablation vs 72.5% in ablation naïve matched controls. On histology of the left atrial appendage (n=198), patients with a failed catheter ablation had a higher density of collagen fibers. Conclusions: Patients with a prior failed catheter ablation had fewer risk factors for AF recurrence but more frequently had AF recurrence after thoracoscopic AF ablation than ablation naïve patients. This may in part be explained by more progressed, subclinical, atrial fibrosis formation.
EClinicalMedicine. 2023 Jun:60:102013. Evaluation of the efficacy and safety of TREM-1 inhibition with nangibotide in patients with COVID-19 receiving respiratory support: the ESSENTIAL randomised, double-blind trial
Bruno François, Simon Lambden, Jean-Jacques Garaud, Marc Derive, Jean-Marie Grouin, Pierre Asfar, Cédric Darreau, Jean-Paul Mira, Jean-Pierre Quenot, Jérémie Lemarié, Emmanuelle Mercier, Jean-Claude Lacherade, Christophe Vinsonneau, Tom Fivez, Julie Helms, Julio Badie, Mitchell Levy, Valérie Cuvier, Margarita Salcedo-Magguilli, Anne-Lise Laszlo-Pouvreau, Pierre-François Laterre, Sébastien Gibot; ESSENTIAL investigators
PMID: 37350989 Abstract Background: Activation of the TREM-1 pathway is associated with outcome in life threatening COVID-19. Data suggest that modulation of this pathway with nangibotide, a TREM-1 modulator may improve survival in TREM-1 activated patients (identified using the biomarker sTREM-1). Methods: Phase 2 double-blind randomized controlled trial assessing efficacy, safety, and optimum treatment population of nangibotide (1.0 mg/kg/h) compared to placebo. Patients aged 18-75 years were eligible within 7 days of SARS-CoV-2 documentation and within 48 h of the onset of invasive or non-invasive respiratory support because of COVID-19-related ARDS. Patients were included from September 2020 to April 2022, with a pause in recruitment between January and August 2021. Primary outcome was the improvement in clinical status defined by a seven-point ordinal scale in the overall population with a planned sensitivity analysis in the subgroup of patients with a sTREM-1 level above the median value at baseline (high sTREM-1 group). Secondary endpoints included safety and all-cause 28-day and day 60 mortality. The study was registered in EudraCT (2020-001504-42) and ClinicalTrials.gov (NCT04429334). Findings: The study was stopped after 220 patients had been recruited. Of them, 219 were included in the mITT analysis. Nangibotide therapy was associated with an improved clinical status at day 28. Fifty-two (52.0%) of patients had improved in the placebo group compared to 77 (64.7%) of the nangibotide treated population, an odds ratio (95% CI) for improvement of 1.79 (1.02-3.14), p = 0.043. In the high sTREM-1 population, 18 (32.7%) of placebo patients had improved by day 28 compared to 26 (48.1%) of treated patients, an odds ratio (95% CI) of 2.17 (0.96-4.90), p = 0.063 was observed. In the overall population, 28 (28.0%) of placebo treated patients were not alive at the day 28 visit compared to 19 (16.0%) of nangibotide treated patients, an absolute improvement (95% CI) in all-cause mortality at day 28, adjusted for baseline clinical status of 12.1% (1.18-23.05). In the high sTREM-1 population (n = 109), 23 (41.8%) of patients in the placebo group and 12 (22.2%) of patients in the nangibotide group were not alive at day 28, an adjusted absolute reduction in mortality of 19.9% (2.78-36.98). The rate of treatment emergent adverse events was similar in both placebo and nangibotide treated patients. Interpretation: Whilst the study was stopped early due to low recruitment rate, the ESSENTIAL study demonstrated that TREM-1 modulation with nangibotide is safe in COVID-19, and results in a consistent pattern of improved clinical status and mortality compared to placebo. The relationship between sTREM-1 and both risk of death and treatment response merits further evaluation of nangibotide using precision medicine approaches in life threatening viral pneumonitis.
Eur J Heart Fail. 2023 Jun;25(6):776-791. Worsening of chronic heart failure: definition, epidemiology, management and prevention. A clinical consensus statement by the Heart Failure Association of the European Society of Cardiology
Marco Metra, Daniela Tomasoni, Marianna Adamo, Antoni Bayes-Genis, Gerasimos Filippatos, Magdy Abdelhamid, Stamatis Adamopoulos, Stefan D Anker, Laura Antohi, Michael Böhm, Frieder Braunschweig, Tuvia Ben Gal, Javed Butler, John G F Cleland, Alain Cohen-Solal, Kevin Damman, Finn Gustafsson, Loreena Hill, Ewa A Jankowska, Mitja Lainscak, Lars H Lund, Theresa McDonagh, Alexandre Mebazaa, Brenda Moura, Wilfried Mullens, Massimo Piepoli, Piotr Ponikowski, Amina Rakisheva, Arsen Ristic, Gianluigi Savarese, Petar Seferovic, Rajan Sharma, Carlo Gabriele Tocchetti, Mehmet Birhan Yilmaz, Cristiana Vitale, Maurizio Volterrani, Stephan von Haehling, Ovidiu Chioncel, Andrew J S Coats, Giuseppe Rosano
PMID: 37208936 Abstract
Episodes of worsening symptoms and signs characterize the clinical course of patients with chronic heart failure (HF). These events are associated with poorer quality of life, increased risks of hospitalization and death and are a major burden on healthcare resources. They usually require diuretic therapy, either administered intravenously or by escalation of oral doses or with combinations of different diuretic classes. Additional treatments may also have a major role, including initiation of guideline-recommended medical therapy (GRMT). Hospital admission is often necessary but treatment in the emergency service or in outpatient clinics or by primary care physicians has become increasingly used. Prevention of first and recurring episodes of worsening HF is an essential component of HF treatment and this may be achieved through early and rapid administration of GRMT. The aim of the present clinical consensus statement by the Heart Failure Association of the European Society of Cardiology is to provide an update on the definition, clinical characteristics, management and prevention of worsening HF in clinical practice.
Artif Organs. 2023 Jun 23. Heterogeneity in Clinical Practices for Post-Cardiotomy Extracorporeal Life Support: a Pilot Survey from the PELS-1 Multicenter Study
Silvia Mariani, Gabor Bari, Justine M Ravaux, Bas C T van Bussel, Maria Elena De Piero, Ann-Kristin Schaefer, Khalil Jawad, Matteo Pozzi, Antonio Loforte, Nikolaos Kalampokas, Agne Jankuviene, Erwan Flecher, Xiaotong Hou, Jeroen J H Bunge, Kogulan Sriranjan, Leonardo Salazar, Bart Meyns, Michael A Mazzeffi, Sacha Matteucci, Sandro Sponga, Kollengode Ramanathan, Alessandro Costetti, Francesco Formica, Pranya Sakiyalak, Antonio Fiore, Chistof Schmid, Giuseppe Maria Raffa, Roberto Castillo, I-Wen Wang, Jae-Seung Jung, Tomas Grus, Vin Pellegrino, Giacomo Bianchi, Matteo Pettinari, Alessandro Barbone, José P Garcia, Mariusz Kowalewski, Kiran Shekar, Glenn Whitman; Roberto Lorusso, the PELS-1 Investigators
PMID: 37351569 Abstract Background: High-quality evidence for post-cardiotomy extracorporeal life support (PC-ECLS) management is lacking. This study investigated the real-world PC-ECLS clinical practices.
Methods: This cross-sectional, multi-institutional, international pilot survey explored center organization, anticoagulation management, left ventricular unloading, distal limb perfusion, PC-ECLS monitoring and transfusions practices. Twenty-nine questions were distributed among 34 hospitals participating in the Post-cardiotomy Extra-Corporeal Life Support Study. Results: Of the 32 centers [16 low-volume (50%); 16 high-volume (50%)] that responded, 16 (50%) had dedicated ECLS specialists. Twenty-six centers (81.3%) reported using additional mechanical circulatory supports. Anticoagulation practices were highly heterogeneous: 24 hospitals (75%) reported using patient's bleeding status as a guide, without a specific threshold in 54.2% of cases. Transfusion targets ranged 7-10 g/dL. Most centers used cardiac venting on a case-by-case basis (78.1%) and regular distal limb perfusion (84.4%). Nineteen (54.9%) centers reported dedicated monitoring protocols including daily echocardiography (87.5%), Swan-Ganz catheterization (40.6%), cerebral near-infrared spectroscopy (53.1%) and multimodal assessment of limb ischemia. Inspection of the circuit (71.9%), oxygenator pressure drop (68.8%), plasma free hemoglobin (75%), d-dimer (59.4%), lactate dehydrogenase (56.3%) and fibrinogen (46.9%) are used to diagnose hemolysis and thrombosis. Conclusions: This study shows remarkable heterogeneity in clinical practices for PC-ECLS management. More standardized protocols and better implementation of available evidence are recommended.
Eur J Heart Fail. 2023 Jul;25(7):1025-1048. Acute heart failure and valvular heart disease: A scientific statement of the Heart Failure Association, the Association for Acute CardioVascular Care and the European Association of Percutaneous Cardiovascular Interventions of the European Society of Cardiology
Ovidiu Chioncel, Marianna Adamo, Maria Nikolaou, John Parissis, Alexandre Mebazaa, Mehmet Birhan Yilmaz, Christian Hassager, Brenda Moura, Johann Bauersachs, Veli-Pekka Harjola, Elena-Laura Antohi, Tuvia Ben-Gal, Sean P Collins, Vlad Anton Iliescu, Magdy Abdelhamid, Jelena Čelutkienė, Stamatis Adamopoulos, Lars H Lund, Mariantonietta Cicoira, Josep Masip 19, Hadi Skouri, Finn Gustafsson, Amina Rakisheva, Ingo Ahrens, Andrea Mortara, Ewa A Janowska, Abdallah Almaghraby, Kevin Damman, Oscar Miro, Kurt Huber, Arsen Ristic, Loreena Hill, Wilfried Mullens, Alaide Chieffo, Jozef Bartunek, Pasquale Paolisso, Antoni Bayes-Genis, Stefan D Anker, Susanna Price, Gerasimos Filippatos, Frank Ruschitzka, Petar Seferovic, Rafael Vidal-Perez, Alec Vahanian, Marco Metra, Theresa A McDonagh, Emanuele Barbato, Andrew J S Coats, Giuseppe M C Rosano
PMID: 37312239 Abstract
Acute heart failure (AHF) represents a broad spectrum of disease states, resulting from the interaction between an acute precipitant and a patient's underlying cardiac substrate and comorbidities. Valvular heart disease (VHD) is frequently associated with AHF. AHF may result from several precipitants that add an acute haemodynamic stress superimposed on a chronic valvular lesion or may occur as a consequence of a new significant valvular lesion. Regardless of the mechanism, clinical presentation may vary from acute decompensated heart failure to cardiogenic shock. Assessing the severity of VHD as well as the correlation between VHD severity and symptoms may be difficult in patients with AHF because of the rapid variation in loading conditions, concomitant destabilization of the associated comorbidities and the presence of combined valvular lesions. Evidence-based interventions targeting VHD in settings of AHF have yet to be identified, as patients with severe VHD are often excluded from randomized trials in AHF, so results from these trials do not generalize to those with VHD. Furthermore, there are not rigorously conducted randomized controlled trials in the setting of VHD and AHF, most of the data coming from observational studies. Thus, distinct to chronic settings, current guidelines are very elusive when patients with severe VHD present with AHF, and a clear-cut strategy could not be yet defined. Given the paucity of evidence in this subset of AHF patients, the aim of this scientific statement is to describe the epidemiology, pathophysiology, and overall treatment approach for patients with VHD who present with AHF.
Eur J Heart Fail. 2023 Jul;25(7):1115-1131. Pre-discharge and early post-discharge management of patients hospitalized for acute heart failure: A scientific statement by the Heart Failure Association of the ESC
Marco Metra, Marianna Adamo, Daniela Tomasoni, Alexandre Mebazaa, Antoni Bayes-Genis, Magdy Abdelhamid, Stamatis Adamopoulos, Stefan D Anker, Johann Bauersachs, Yuri Belenkov, Michael Böhm, Tuvia Ben Gal, Javed Butler, Alain Cohen-Solal, Gerasimos Filippatos, Finn Gustafsson, Loreena Hill, Tiny Jaarsma, Ewa A Jankowska, Mitja Lainscak, Yuri Lopatin, Lars H Lund Theresa McDonagh, Davor Milicic, Brenda Moura, Wilfried Mullens, Massimo Piepoli, Marija Polovina, Piotr Ponikowski, Amina Rakisheva, Arsen Ristic, Gianluigi Savarese, Petar Seferovic, Rajan Sharma, Thomas Thum, Carlo G Tocchetti, Sophie Van Linthout, Cristiana Vitale, Stephan Von Haehling, Maurizio Volterrani, Andrew J S Coats, Ovidiu Chioncel, Giuseppe Rosano
PMID: 37448210 Abstract
Acute heart failure is a major cause of urgent hospitalizations. These are followed by marked increases in death and rehospitalization rates, which then decline exponentially though they remain higher than in patients without a recent hospitalization. Therefore, optimal management of patients with acute heart failure before discharge and in the early post-discharge phase is critical. First, it may prevent rehospitalizations through the early detection and effective treatment of residual or recurrent congestion, the main manifestation of decompensation. Second, initiation at pre-discharge and titration to target doses in the early post-discharge period, of guideline-directed medical therapy may improve both short- and long-term outcomes. Third, in chronic heart failure, medical treatment is often left unchanged, so the acute heart failure hospitalization presents an opportunity for implementation of therapy. The aim of this scientific statement by the Heart Failure Association of the European Society of Cardiology is to summarize recent findings that have implications for clinical management both in the pre-discharge and the early post-discharge phase after a hospitalization for acute heart failure.
Ann Thorac Surg. 2023 Jul;116(1):147-154. The Relation Between Obesity and Mortality in Postcardiotomy Venoarterial Membrane Oxygenation
Samuel Heuts, Silvia Mariani, Bas C T van Bussel, Udo Boeken, Robertas Samalavicius, Karl Bounader, Xiaotong Hou, Jeroen J H Bunge, Kogulan Sriranjan, Dominik Wiedemann, Diyar Saeed, Matteo Pozzi, Antonio Loforte, Leonardo Salazar, Bart Meyns, Michael A Mazzeffi, Sacha Matteucci, Sandro Sponga 18, Vitaly Sorokin, Claudio Russo, Francesco Formica, Pranya Sakiyalak, Antonio Fiore, Daniele Camboni, Giuseppe Maria Raffa, Rodrigo Diaz, I-Wen Wang, Jae-Seung Jung, Jan Belohlavek, Vin Pellegrino, Giacomo Bianchi, Matteo Pettinari, Alessandro Barbone, José P Garcia, Kiran Shekar, Glenn Whitman, Roberto Lorusso; PELS-1 Investigators
PMID: 37015310 Abstract
Background: Obesity is an important health problem in cardiac surgery and among patients requiring postcardiotomy venoarterial extracorporeal membrane oxygenation (V-A ECMO). Still, whether these patients are at risk for unfavorable outcomes after postcardiotomy V-A ECMO remains unclear. The current study evaluated the association between body mass index (BMI) and in-hospital outcomes in this setting.
Methods: The Post-cardiotomy Extracorporeal Life Support (PELS-1) study is an international, multicenter study. Patients requiring postcardiotomy V-A ECMO in 36 centers from 16 countries between 2000 and 2020 were included. Patients were divided in 6 BMI categories (underweight, normal weight, overweight, class I, class II, and class III obesity) according to international recommendations. Primary outcome was in-hospital mortality, and secondary outcomes included major adverse events. Mixed logistic regression models were applied to evaluate associations between BMI and mortality.
Results: The study cohort included 2046 patients (median age, 65 years; 838 women [41.0%]). In-hospital mortality was 60.3%, without statistically significant differences among BMI classes for in-hospital mortality (P = .225) or major adverse events (P = .126). The crude association between BMI and in-hospital mortality was not statistically significant after adjustment for comorbidities and intraoperative variables (class I: odds ratio [OR], 1.21; 95% CI, 0.88-1.65; class II: OR, 1.45; 95% CI, 0.86-2.45; class III: OR, 1.43; 95% CI, 0.62-3.33), which was confirmed in multiple sensitivity analyses.
Conclusions: BMI is not associated to in-hospital outcomes after adjustment for confounders in patients undergoing postcardiotomy V-A ECMO. Therefore, BMI itself should not be incorporated in the risk stratification for postcardiotomy V-A ECMO.
Neuromodulation. 2023 Jul;26(5):1074-1080. Long-Term Evaluation of Spinal Cord Stimulation in Patients With Painful Diabetic Polyneuropathy: An Eight-to-Ten-Year Prospective Cohort Study
Xander Zuidema, Elke van Daal, Iris van Geel, Thomas J de Geus, Sander M J van Kuijk, Bastiaan E de Galan, Nelleke de Meij, Jan Van Zundert
PMID: 36587999 Abstract
Objective: This study aimed to evaluate the long-term effects of spinal cord stimulation (SCS) in patients with painful diabetic polyneuropathy (PDPN).
Materials and methods: This prospective cohort study was the eight-to-ten-year follow-up of a previously performed pilot and randomized controlled trial on the effects of SCS in PDPN, initiated by the multidisciplinary pain center of Maastricht University Medical Center+. The study population consisted of a subgroup of patients who still used SCS treatment ≥ eight years after implantation (n = 19). Pain intensity scores (numeric rating scale [NRS]) during the day and night and data on secondary outcomes (ie, quality of life, depression, sleep quality) were reported during yearly follow-up consultations. Long-term efficacy of SCS was analyzed by comparing the most recently obtained data eight to ten years after implantation with those obtained at baseline.
Results: Pain intensity, day and night, was significantly (p 0.01) reduced by 2.3 (NRS 6.6-4.3) and 2.2 (NRS 6.8-4.6) points, respectively, when comparing the long-term data with baseline. Moreover, for > 50% of patients, the pain reduction was > 30%, which is considered clinically meaningful. No differences were found regarding the secondary outcomes.
Conclusion: This eight-to-ten-year follow-up study indicates that SCS can remain an effective treatment in the long term to reduce pain intensity in a subcohort of patients with PDPN who still had an SCS device implanted after eight years.
Nutrients. 2023 Jul 14;15(14):3152. Mental Health during the Interpregnancy Period and the Association with Pre-Pregnancy Body Mass Index and Body Composition: Data from the INTER-ACT Randomized Controlled Trial
Hanne Van Uytsel, Lieveke Ameye, Roland Devlieger, Yves Jacquemyn, Caroline Van Holsbeke, Annick Schreurs, Annick Bogaerts
PMID: 37513569 Abstract
Mental health problems and obesity are two common complications during pregnancy and postpartum. The preconception period is considered an appropriate period for prevention. Therefore, insights into interpregnancy mental health and the impact on weight and body composition are of interest to developing effective weight management strategies. The primary aim of this study is to assess the difference in women's mental health during the interpregnancy period and the association with pre-pregnancy body mass index (BMI) and body composition. The secondary aim is to study whether this association is affected by socio-demographic factors, interpregnancy interval and sleep. The study is a secondary analysis of the INTER-ACT e-health-supported lifestyle trial. Women were eligible if they had a subsequent pregnancy and mental health measurements at 6 weeks after childbirth and at the start of the next pregnancy (n = 276). We used univariate analyses to assess differences in mental health and performed regression analysis to assess their association with pre-pregnancy BMI and body composition at the start of the next pregnancy. Our results show a statistically significant increase in anxiety and depressive symptoms between 6 weeks after childbirth and the start of the next pregnancy (sSTAI-6 ≥ 40: +13%, p =≤ 0.001; GMDS ≥ 13: +9%, p = 0.01). Of the women who were not anxious at 6 weeks after childbirth (sSTAI 40), more than one-third (39%) developed anxiety at the start of the next pregnancy (p =≤ 0.001). Regression analysis showed that sense of coherence (SOC-13) at the start of the next pregnancy was independently associated with women's pre-pregnancy BMI and fat percentage. We believe that the development of preconception lifestyle interventions that focus on both weight reduction and support in understanding, managing and giving meaning to stressful events (sense of coherence) may be of added value in optimizing women's preconception health.
Arch Orthop Trauma Surg. 2023 Jul;143(7):4425-4436. The pre-diseased coronal alignment can be predicted from conventional radiographs taken of the varus arthritic knee
William Colyn, A Cleymans, L Bruckers, J Truijen, K Smeets, J Bellemans
PMID: 36494462 Abstract
Introduction: The concept of restoring the constitutional, pre-diseased alignment has gained lots of interest among knee surgeons. Previous attempts to use the contralateral limb to bridge the gap between the arthritic and the constitutional alignment were unsuccessful. We investigated the usability of a mathematical formula to predict the constitutional (pre-diseased) coronal alignment once arthritis has occurred. It is our hypothesis that by using the KL grade, CPAK classification and four radiographic measurements of the arthritic knee, the pre-diseased coronal alignment could be predicted.
Material and methods: Hundred arthritic patients with consecutive X-rays were used to determine a mathematical formula. Five alignment parameters were determined on full-length X-rays: HKA angle, mechanical lateral distal femoral angle (mLDFA), medial proximal tibial angle (MPTA), joint line convergence angle (JLCA) and the tibial joint line angle (TJLA). A refinement of the algorithm was implemented based on a reference cohort, consisted of 250 young adults aged between 20 and 27 years. Moreover, all knees were subdivided based on their CPAK-phenotype and the Kellgren-Lawrence scale (KL scale). An independent arthritic cohort of 289 patients scheduled for primary total knee arthroplasty was included to verify the accuracy of the predicted HKAs (HKAPRED).
Results: In CPAK type 1, the HKAPRED was 3.86° varus (STD 1.39) and the HKAYHA was 4.0° varus. In CPAK type 2, the HKAPRED was 1.68° varus (STD 1.95) compared to a HKAYHA of 1.34° (STD 0.81). The average constitutional HKA is not different in both CPAK 1 (p = 0.61) and CPAK 2 (p = 0.25), and the difference in the mean is estimated to be equal to - 0.14 (95CI - 0.68 to 0.40) in CPAK 1 and 0.35 (95CI - 0.06 to 0.75) in CPAK 2.
Conclusion: Using the KL grade, CPAK classification and four radiographic measurements of the arthritic knee, the pre-diseased coronal alignment can be predicted in 80% of the varus knees with an accuracy of ≤ 0.5°. The predicted HKA (HKAPRED) can be very useful in the current and future clinical practice.
Reg Anesth Pain Med. 2023 Jul 9:rapm-2022-104310. Pulsed radiofrequency treatment of the Gasserian ganglion for trigeminal neuralgia: a retrospective study (PROGRESS) Jan Van Zundert, Matthias Vanderdonckt, Klaas Buyse, Roel Mestrum, Dieter Mesotten, Koen Van Boxem
PMID: 37429618
No abstract available
JACC Clin Electrophysiol. 2023 Jul;9(7 Pt 2):1013-1023. Hybrid Ablation Versus Repeated Catheter Ablation in Persistent Atrial Fibrillation: A Randomized Controlled Trial
Claudia A J van der Heijden, Vanessa Weberndörfer, Mindy Vroomens, Justin G Luermans, Sevasti-Maria Chaldoupi, Elham Bidar, Kevin Vernooy, Jos G Maessen, Laurent Pison, Sander M J van Kuijk, Mark La Meir, Harry J G M Crijns, Bart Maesen
PMID: 36752455 Abstract
Background: Although catheter ablation (CA) is successful for the treatment of paroxysmal atrial fibrillation (AF), results are less satisfactory in persistent AF. Hybrid ablation (HA) results in better outcomes in patients with persistent atrial fibrillation (persAF), as it combines a thoracoscopic epicardial and transvenous endocardial approach in a single procedure.
Objectives: The purpose of this study was to compare the effectiveness and safety of HA with CA in a prospective, superiority, unblinded, randomized controlled trial.
Methods: Forty-one ablation-naive patients with (long-standing)-persAF were randomized to HA (n = 19) or CA (n = 22) and received pulmonary vein isolation, posterior left atrial wall isolation and, if needed, a cavotricuspid isthmus ablation. The primary efficacy endpoint was freedom from any atrial tachyarrhythmia >5 minutes off antiarrhythmic drugs after 12 months. The primary and secondary safety endpoints included major and minor complications and the total number of serious adverse events.
Results: After 12 months, the freedom of atrial tachyarrhythmias off antiarrhythmic drugs was higher in the HA group compared with the CA group (89% vs 41%, P = 0.002). There was 1 pericarditis requiring pericardiocentesis and 1 femoral arteriovenous-fistula in the HA group. In the CA arm, 1 bleeding from the femoral artery occurred. There were no deaths, strokes, need for pacemaker implantation, or conversions to sternotomy, and the number of (serious) adverse events was comparable between groups (21% vs 14%, P = 0.685).
Conclusions: Hybrid AF ablation is an efficacious and safe procedure and results in better outcomes than catheter ablation for the treatment of patients with persistent AF. (Hybrid Versus Catheter Ablation in Persistent AF [HARTCAP-AF]; NCT02441738).
Neuroradiology. 2023 Jul;65(7):1091-1099. Artificial intelligence tools in clinical neuroradiology: essential medico-legal aspects
Dennis M Hedderich, Christian Weisstanner, Sofie Van Cauter, Christian Federau, Myriam Edjlali, Alexander Radbruch, Sara Gerke, Sven Haller
PMID: 37160454 Abstract
Commercial software based on artificial intelligence (AI) is entering clinical practice in neuroradiology. Consequently, medico-legal aspects of using Software as a Medical Device (SaMD) become increasingly important. These medico-legal issues warrant an interdisciplinary approach and may affect the way we work in daily practice. In this article, we seek to address three major topics: medical malpractice liability, regulation of AI-based medical devices, and privacy protection in shared medical imaging data, thereby focusing on the legal frameworks of the European Union and the USA. As many of the presented concepts are very complex and, in part, remain yet unsolved, this article is not meant to be comprehensive but rather thought-provoking. The goal is to engage clinical neuroradiologists in the debate and equip them to actively shape these topics in the future.
J Neurol Phys Ther. 2023 Jul 1;47(3):127-138. Gait and Falls in Benign Paroxysmal Positional Vertigo: A Systematic Review and Meta-analysis
Sara Pauwels, Laura Casters, Nele Lemkens, Winde Lemmens, Kenneth Meijer, Pieter Meyns, Raymond van de Berg, Joke Spildooren
PMID: 36897200 Abstract
Background and purpose: Benign paroxysmal positional vertigo (BPPV) is one of the most common vestibular disorders, and is treated effectively with particle repositioning maneuvers (PRM). The aim of this study was to assess the influence of BPPV and treatment effects of PRM on gait, falls, and fear of falling.
Methods: Three databases and the reference lists of included articles were systematically searched for studies comparing gait and/or falls between (1) people with BPPV (pwBPPV) and controls and (2) pre- and posttreatment with PRM. The Joanna Briggs Institute critical appraisal tools were used to assess risk of bias.
Results: Twenty of the 25 included studies were suitable for meta-analysis. Quality assessment resulted in 2 studies with high risk of bias, 13 with moderate risk, and 10 with low risk. PwBPPV walked slower and demonstrated more sway during tandem walking compared with controls. PwBPPV also walked slower during head rotations. After PRM, gait velocity during level walking increased significantly, and gait became safer according to gait assessment scales. Impairments during tandem walking and walking with head rotations did not improve. The number of fallers was significantly higher for pwBPPV than for controls. After treatment, the number of falls, number of pwBPPV who fell, and fear of falling decreased.
Discussion and conclusions: BPPV increases the odds of falls and negatively impacts spatiotemporal parameters of gait. PRM improves falls, fear of falling, and gait during level walking. Additional rehabilitation might be necessary to improve gait while walking with head movements or tandem walking.
Acta Cardiol. 2023 Jul;78(5):552-564. The use of glucagon-like-peptide-1 receptor agonist in the cardiology practice Pieter Martens, Chantal Mathieu, Thomas Vanassche
PMID: 35575294 Abstract
The presence of type 2 diabetes confronts the patient with an elevated risk to develop atherosclerotic cardiovascular disease (ASCVD), heart failure (HF), or chronic kidney disease (CKD). Glucose control in itself does not prevent these complications in their entirety. More recently several agents within the class of Sodium-Glucose cotransporter 2 inhibitors (SGLT2-I) and Glucagon-like-peptide-1 receptor agonists (GLP-1RA) have emerged as preferred agents to tackle the residual risk of ASCVD, HF, and CKD in patients with type 2 diabetes. Despite compelling trial data and professional society endorsement, the uptake of these agents in clinical practice is low. Especially GLP-1RA is only used in 8% of eligible candidates with type 2 diabetes and 5% of these prescriptions are attributed to cardiologists. This low uptake amongst cardiologists is related to the unfamiliarity with this class, its initiation, and titration, hesitation regarding simultaneous adjustment of other glucose-lowering agents, the unaccustomedness to prescribing injectable agents, and differential medical priorities. This review aims to offer cardiologists a practical tool for the optimal use of a GLP-1RA in their suitable patients and is focussed on the Belgian field of practice.
Eur J Heart Fail. 2023 Jul;25(7):936-955. Patient phenotype profiling in heart failure with preserved ejection fraction to guide therapeutic decision making. A scientific statement of the Heart Failure Association, the European Heart Rhythm Association of the European Society of Cardiology, and the European Society of Hypertension
Stefan D Anker, Muhammad Shariq Usman, Markus S Anker, Javed Butler, Michael Böhm, William T Abraham, Marianna Adamo, Vijay K Chopra, Mariantonietta Cicoira, Francesco Cosentino, Gerasimos Filippatos, Ewa A Jankowska, Lars H Lund, Brenda Moura, Wilfried Mullens, Burkert Pieske, Piotr Ponikowski, Jose R Gonzalez-Juanatey, Amina Rakisheva, Gianluigi Savarese, Petar Seferovic, John R Teerlink, Carsten Tschöpe, Maurizio Volterrani, Stephan von Haehling, Jian Zhang, Yuhui Zhang, Johann Bauersachs, Ulf Landmesser, Shelley Zieroth, Konstantinos Tsioufis, Antoni Bayes-Genis, Ovidiu Chioncel, Felicita Andreotti, Enrico Agabiti-Rosei, Jose L Merino, Marco Metra, Andrew J S Coats, Giuseppe M C Rosano
PMID: 37461163 Abstract
Heart failure with preserved ejection fraction (HFpEF) represents a highly heterogeneous clinical syndrome affected in its development and progression by many comorbidities. The left ventricular diastolic dysfunction may be a manifestation of various combinations of cardiovascular, metabolic, pulmonary, renal, and geriatric conditions. Thus, in addition to treatment with sodium-glucose cotransporter 2 inhibitors in all patients, the most effective method of improving clinical outcomes may be therapy tailored to each patient's clinical profile. To better outline a phenotype-based approach for the treatment of HFpEF, in this joint position paper, the Heart Failure Association of the European Society of Cardiology, the European Heart Rhythm Association and the European Hypertension Society, have developed an algorithm to identify the most common HFpEF phenotypes and identify the evidence-based treatment strategy for each, while taking into account the complexities of multiple comorbidities and polypharmacy.
J Am Heart Assoc. 2023 Jul 18;12(14):e029609. Patient and Management Variables Associated With Survival After Postcardiotomy Extracorporeal Membrane Oxygenation in Adults: The PELS-1 Multicenter Cohort Study
Silvia Mariani, Samuel Heuts, Bas C T van Bussel, Michele Di Mauro, Dominik Wiedemann, Diyar Saeed, Matteo Pozzi, Antonio Loforte, Udo Boeken, Robertas Samalavicius, Karl Bounader, Xiaotong Hou, Jeroen J H Bunge, Hergen Buscher, Leonardo Salazar, Bart Meyns, Daniel Herr, Marco L Sacha Matteucci, Sandro Sponga, Graeme MacLaren, Claudio Russo, Francesco Formica, Pranya Sakiyalak, Antonio Fiore, Daniele Camboni, Giuseppe Maria Raffa, Rodrigo Diaz, I-Wen Wang, Jae-Seung Jung, Jan Belohlavek, Vin Pellegrino, Giacomo Bianchi, Matteo Pettinari, Alessandro Barbone, José P Garcia, Kiran Shekar, Glenn J R Whitman, Roberto Lorusso; PELS‐1 Investigators *
PMID: 37421269 Abstract
Background Extracorporeal membrane oxygenation (ECMO) has been increasingly used for postcardiotomy cardiogenic shock, but without a concomitant reduction in observed in-hospital mortality. Long-term outcomes are unknown. This study describes patients' characteristics, in-hospital outcome, and 10-year survival after postcardiotomy ECMO. Variables associated with in-hospital and postdischarge mortality are investigated and reported. Methods and Results The retrospective international multicenter observational PELS-1 (Postcardiotomy Extracorporeal Life Support) study includes data on adults requiring ECMO for postcardiotomy cardiogenic shock between 2000 and 2020 from 34 centers. Variables associated with mortality were estimated preoperatively, intraoperatively, during ECMO, and after the occurrence of any complications, and then analyzed at different time points during a patient's clinical course, through mixed Cox proportional hazards models containing fixed and random effects. Follow-up was established by institutional chart review or contacting patients. This analysis included 2058 patients (59% were men; median [interquartile range] age, 65.0 [55.0-72.0] years). In-hospital mortality was 60.5%. Independent variables associated with in-hospital mortality were age (hazard ratio [HR], 1.02 [95% CI, 1.01-1.02]) and preoperative cardiac arrest (HR, 1.41 [95% CI, 1.15-1.73]). In the subgroup of hospital survivors, the overall 1-, 2-, 5-, and 10-year survival rates were 89.5% (95% CI, 87.0%-92.0%), 85.4% (95% CI, 82.5%-88.3%), 76.4% (95% CI, 72.5%-80.5%), and 65.9% (95% CI, 60.3%-72.0%), respectively. Variables associated with postdischarge mortality included older age, atrial fibrillation, emergency surgery, type of surgery, postoperative acute kidney injury, and postoperative septic shock. Conclusions In adults, in-hospital mortality after postcardiotomy ECMO remains high; however, two-thirds of those who are discharged from hospital survive up to 10 years. Patient selection, intraoperative decisions, and ECMO management remain key variables associated with survival in this cohort. Registration URL: https://www.clinicaltrials.gov; Unique identifier: NCT03857217.
Heart Fail Clin. 2023 Jul;19(3):357-377. Arrythmia-Mediated Valvular Heart Disease Sébastien Deferm, Philippe B Bertrand, Sebastiaan Dhont, Ralph S von Bardeleben, Pieter M Vandervoort
PMID: 37230650 Abstract
The aging population is rising at record pace worldwide. Along with it, a steep increase in the prevalence of atrial fibrillation and heart failure with preserved ejection fraction is to be expected. Similarly, both atrial functional mitral and tricuspid regurgitation (AFMR and AFTR) are increasingly observed in daily clinical practice. This article summarizes all current evidence regarding the epidemiology, prognosis, pathophysiology, and therapeutic options. Specific attention is addressed to discern AFMR and AFTR from their ventricular counterparts, given their different pathophysiology and therapeutic needs.
Arch Dis Child Fetal Neonatal Ed. 2023 Jul;108(4):373-379. Effect of systemic hydrocortisone in ventilated preterm infants on parent-reported behavioural outcomes at 2 years' corrected age: follow-up of a randomised clinical trial
Nienke Marjolein Halbmeijer, Wes Onland, Filip Cools, Renate M Swarte, Marja van der Heide-Jalving, Peter Dijk, Susanne Mulder-de Tollenaer, Ratna N G B Tan, Thilo Mohns, Els Bruneel, Arno F J van Heijst, Boris Kramer, Anne Debeer, Mirjam M van Weissenbruch, Yoann Marechal, Henry Blom, Katleen Plaskie, Martin Offringa, Aleid G van Wassenaer-Leemhuis, Anton H van Kaam, Cornelieke S H Aarnoudse-Moens; SToP-BPD study group
PMID: 36593110 Abstract
Objective: To report the parent-reported behavioural outcomes of infants included in the Systemic Hydrocortisone To Prevent Bronchopulmonary Dysplasia in preterm infants study at 2 years' corrected age (CA).
Design: Randomised placebo-controlled trial.
Setting: Dutch and Belgian neonatal intensive care units.
Patients: Infants born 30 weeks' gestation and/or birth weight 1250 g, and ventilator dependent in the second week of life.
Intervention: Infants were randomly assigned to a 22-day course of systemic hydrocortisone (cumulative dose 72.5 mg/kg; n=182) or placebo (n=190).
Main outcome measures: Parent-reported behavioural outcomes at 2 years' CA assessed with the Child Behavior Checklist (CBCL 1½-5).
Results: Parents completed the CBCL of 183 (70% (183/262)) infants (hydrocortisone group, n=96; placebo group, n=87). Multiple imputation was used to account for missing data. Infants with critically elevated T-scores (>55) were found in 22.9%, 19.1% and 29.4% of infants for total, internalising and externalising problems, respectively; these scores were not significantly different between groups (mean difference -1.52 (95% CI -4.00 to 0.96), -2.40 (95% CI -4.99 to 0.20) and -0.81 (95% CI -3.40 to 1.77), respectively). In the subscales, we found a significantly lower T-score for anxiety problems in the hydrocortisone group (mean difference -1.26, 95% CI -2.41 to -0.12).
Conclusion: This study found high rates of behaviour problems at 2 years' CA following very preterm birth, but these problems were not associated with hydrocortisone treatment initiated between 7 and 14 days after birth in ventilated preterm infants.
Clin Kidney J. 2023 Jul 6;16(10):1701-1702. Focal segmental glomerulosclerosis associated with the use of the IL-23 inhibitor guselkumab
Marijke Stryckers, Stefaan Van Oevelen, Priyanka Koshy, Ben Sprangers, Amaryllis H Van Craenenbroeck
PMID: 37779841 Abstract
We report a case of a 38-year-old man who developed a nephrotic syndrome shortly after the start of guselkumab for the treatment of plaque psoriasis. Renal biopsy showed focal segmental glomerulosclerosis (FSGS). The clinical course of our case is highly suspect for drug-induced FSGS since the nephrotic syndrome resolved after cessation of the drug without relapse (2 years of follow-up). To the best of our knowledge, this is the first case describing FSGS lesions associated with the use of an interleukin-23 inhibitor.
Am J Emerg Med. 2023 Aug:70:1-9. Hyperkalemia in acute heart failure: Short term outcomes from the EAHFE registry
Zubaid Rafique, Maria José Fortune, Dick Kuo, Lukasz Szarpak, Lluís Llauger, Begoña Espinosa, Víctor Gil, Javier Jacob, Aitor Alquézar-Arbé, Juan Antonio Andueza, José Manuel Garrido, Alfons Aguirre, Marta Fuentes, Héctor Alonso, Francisco Javier Lucas-Imbernón, Carlos Bibiano, Guillermo Burillo-Putze, Julio Núñez, Wilfried Mullens, Pedro Lopez-Ayala, Christian Mueller, Pere Llorens, Frank Peacock, Òscar Miró; ICA-SEMES Research Group
PMID: 37186977 Corrigendum to "Hyperkalemia in acute heart failure: Short term outcomes from the EAHFE registry" [American Journal of Emergency Medicine, 70C (2023) 1-9].
Rafique Z, Fortuny MJ, Kuo D, Szarpak L, Llauger L, Espinosa B, Gil V, Jacob J, Alquézar-Arbé A, Andueza JA, Garrido JM, Aguirre A, Fuentes M, Alonso H, Lucas-Imbernón FJ, Bibiano C, Burillo-Putze G, Núñez J, Mullens W, Lopez-Ayala P, Mueller C, Llorens P, Peacock F, Miró Ò; ICA-SEMES Research Group.
Am J Emerg Med. 2023 Sep;71:251.
PMID: 37268493 No abstract available.
J Arrhythm. 2023 Aug 2;39(5):681-756. 2023 HRS/APHRS/LAHRS guideline on cardiac physiologic pacing for the avoidance and mitigation of heart failure
Mina K Chung, Kristen K Patton, Chu-Pak Lau, Alexander R J Dal Forno, Sana M Al-Khatib, Vanita Arora, Ulrika Maria Birgersdotter-Green, Yong-Mei Cha, Eugene H Chung, Edmond M Cronin, Anne B Curtis, Iwona Cygankiewicz, Gopi Dandamudi, Anne M Dubin, Douglas P Ensch, Taya V Glotzer, Michael R Gold, Zachary D Goldberger, Rakesh Gopinathannair, Eiran Z Gorodeski, Alejandra Gutierrez, Juan C Guzman, Weijian Huang, Peter B Imrey, Julia H Indik, Saima Karim, Peter P Karpawich, Yaariv Khaykin, Erich L Kiehl, Jordana Kron, Valentina Kutyifa, Mark S Link, Joseph E Marine, Wilfried Mullens, Seung-Jung Park, Ratika Parkash, Manuel F Patete, Rajeev Kumar Pathak, Carlos A Perona, John Rickard, Mark H Schoenfeld, Swee-Chong Seow, Win-Kuang Shen, Morio Shoda, Jagmeet P Singh, David J Slotwiner, Arun Raghav M Sridhar, Uma N Srivatsa, Eric C Stecker, Tanyanan Tanawuttiwat, W H Wilson Tang, Carlos Andres Tapias, Cynthia M Tracy, Gaurav A Upadhyay, Niraj Varma, Kevin Vernooy, Pugazhendhi Vijayaraman, Sarah Ann Worsnick, Wojciech Zareba, Emily P Zeitler; Document Reviewers; Nestor Lopez-Cabanillas
PMID: 37799799 Abstract
Cardiac physiologic pacing (CPP), encompassing cardiac resynchronization therapy (CRT) and conduction system pacing (CSP), has emerged as a pacing therapy strategy that may mitigate or prevent the development of heart failure (HF) in patients with ventricular dyssynchrony or pacing-induced cardiomyopathy. This clinical practice guideline is intended to provide guidance on indications for CRT for HF therapy and CPP in patients with pacemaker indications or HF, patient selection, pre-procedure evaluation and preparation, implant procedure management, follow-up evaluation and optimization of CPP response, and use in pediatric populations. Gaps in knowledge, pointing to new directions for future research, are also identified.
Am J Emerg Med. 2023 Aug:70:1-9. Hyperkalemia in acute heart failure: Short term outcomes from the EAHFE registry
Zubaid Rafique, Maria José Fortuny, Dick Kuo, Lukasz Szarpak, Lluís Llauger, Begoña Espinosa, Víctor Gil, Javier Jacob, Aitor Alquézar-Arbé, Juan Antonio Andueza, José Manuel Garrido 10, Alfons Aguirre, Marta Fuentes, Héctor Alonso, Francisco Javier Lucas-Imbernón, Carlos Bibiano, Guillermo Burillo-Putze, Julio Núñez, Wilfried Mullens, Pedro Lopez-Ayala, Christian Mueller, Pere Llorens, Frank Peacock, Òscar Miró; ICA-SEMES Research Group
PMID: 37186977
Corrigendum to "Hyperkalemia in acute heart failure: Short term outcomes from the EAHFE registry" [American Journal of Emergency Medicine, 70C (2023) 1-9]. PMID: 37268493 Abstract
Objective: Both hyperkalemia (HK) and Acute Heart Failure (AHF) are associated with increased short-term mortality, and the management of either may exacerbate the other. As the relationship between HK and AHF is poorly described, our purpose was to determine the relationship between HK and short-term outcomes in Emergency Department (ED) AHF.
Methods: The EAHFE Registry enrolls all ED AHF patients from 45 Spanish ED and records in-hospital and post-discharge outcomes. Our primary outcome was all-cause in-hospital death, with secondary outcomes of prolonged hospitalization (>7 days) and 7-day post-discharge adverse events (ED revisit, hospitalization, or death). Associations between serum potassium (sK) and outcomes were explored using logistic regression by restricted cubic spline (RCS) curves, with sK =4.0 mEq/L as the reference, adjusting by age, sex, comorbidities, patient baseline status and chronic treatments. Interaction analyses were performed for the primary outcome.
Results: Of 13,606 ED AHF patients, the median (IQR) age was 83 (76-88) years, 54% were women, and the median (IQR) sK was 4.5 mEq/L (4.3-4.9) with a range of 4.0-9.9 mEq/L. In-hospital mortality was 7.7%, with prolonged hospitalization in 35.9%, and a 7-day post-discharge adverse event rate of 8.7%. Adjusted in-hospital mortality increased steadily from sK ≥4.8 (OR = 1.35, 95% CI = 1.01-1.80) to sK = 9.9 (8.41, 3.60-19.6). Non-diabetics with elevated sK had higher odds of death, while chronic treatment with mineralocorticoid-receptor antagonists exhibited a mixed effect. Neither prolonged hospitalization nor post-discharge adverse events was associated with sK.
Conclusion: In ED AHF, initial sK >4.8 mEq/L was independently associated with in-hospital mortality, suggesting that this cohort may benefit from aggressive HK treatment.
J Am Coll Cardiol. 2023 Aug 8;82(6):489-499. Right Ventricular Function and Pulmonary Coupling in Patients With Heart Failure and Preserved Ejection Fraction
Riccardo M Inciardi, Martin Abanda, Amil M Shah, Maja Cikes, Brian Claggett, Hicham Skali, Muthiah Vaduganathan, Narayana Prasad, Sheldon Litwin, Bela Merkely, Annamaria Kosztin, Klaudia Vivien Nagy, Sanjiv J Shah, Wilfried Mullens, Michael R Zile, Carolyn S P Lam, Marc A Pfeffer, John J V McMurray, Scott D Solomon; PARAGON-HF Investigators
PMID: 37225045 Abstract
Background: Limited data exist to characterize novel measures of right ventricular (RV) function and the coupling to pulmonary circulation in patients with heart failure and preserved left ventricular ejection fraction (HFpEF).
Objectives: This study sought to assess the clinical implications of RV function, the association with N-terminal pro-B-type natriuretic peptide, and the risk for adverse events among patients with HFpEF.
Methods: This study analyzed measures of RV function by assessing absolute RV free wall longitudinal strain (RVFWLS) and its ratio to estimated pulmonary artery systolic pressure (PASP) (RVFWLS/PASP ratio) in 528 patients (mean age 74 ± 8 years, 56% female) with adequate echocardiographic images quality enrolled in the PARAGON-HF trial. Associations with baseline N-terminal pro-B-type natriuretic peptide and with total HF hospitalizations and cardiovascular death were assessed, after accounting for confounders.
Results: Overall, 311 patients (58%) had evidence of RV dysfunction, defined as absolute RVFWLS 20%, and among the 388 patients (73%) with normal tricuspid annular planar systolic excursion and RV fractional area change, more than one-half showed impaired RV function. Lower values of RVFWLS and RVFWLS/PASP ratios were significantly associated with higher circulating N-terminal pro-B-type natriuretic peptide. With a median follow-up of 2.8 years, there were 277 total HF hospitalizations and cardiovascular deaths. Both absolute RVFWLS (HR: 1.39; 95% CI: 1.05-1.83; P = 0.018) and RVFWLS/PASP ratio (HR: 1.43; 95% CI: 1.13-1.80; P = 0.002) were significantly associated with the composite outcome. Treatment effect of sacubitril/valsartan was not modified by measures of RV function.
Conclusions: Worsening RV function and its ratio to pulmonary pressure is common and significantly associated with an increased risk of HF hospitalizations and cardiovascular death in patients with HFpEF. (Efficacy and Safety of LCZ696 Compared to Valsartan, on Morbidity and Mortality in Heart Failure Patients With Preserved Ejection Fraction [PARAGON-HF]; NCT01920711).
ESC Heart Fail. 2023 Aug;10(4):2159-2169. Optimizing outcomes in heart failure: 2022 and beyond
Ewa A Jankowska, Tomas Andersson, Claudia Kaiser-Albers, Biykem Bozkurt, Ovidiu Chioncel, Andrew J S Coats, Loreena Hill, Friedrich Koehle, Lars H Lund, Theresa McDonagh, Marco Metra, Clemens Mittmann, Wilfried Mullens, Uwe Siebert, Scott D Solomon, Maurizio Volterrani, John J V McMurray
PMID: 37060168 Abstract
Although the development of therapies and tools for the improved management of heart failure (HF) continues apace, day-to-day management in clinical practice is often far from ideal. A Cardiovascular Round Table workshop was convened by the European Society of Cardiology (ESC) to identify barriers to the optimal implementation of therapies and guidelines and to consider mitigation strategies to improve patient outcomes in the future. Key challenges identified included the complexity of HF itself and its treatment, financial constraints and the perception of HF treatments as costly, failure to meet the needs of patients, suboptimal outpatient management, and the fragmented nature of healthcare systems. It was discussed that ongoing initiatives may help to address some of these barriers, such as changes incorporated into the 2021 ESC HF guideline, ESC Heart Failure Association quality indicators, quality improvement registries (e.g. EuroHeart), new ESC guidelines for patients, and the universal definition of H. Additional priority action points discussed to promote further improvements included revised definitions of HF 'phenotypes' based on trial data, the development of implementation strategies, improved affordability, greater regulator/payer involvement, increased patient education, further development of patient-reported outcomes, better incorporation of guidelines into primary care systems, and targeted education for primary care practitioners. Finally, it was concluded that overarching changes are needed to improve current HF care models, such as the development of a standardized pathway, with a common adaptable digital backbone, decision-making support, and data integration, to ensure that the model 'learns' as the management of HF continues to evolve.
Artif Organs. 2023 Aug;47(8):1386-1394. Extracorporeal life support in mitral papillary muscle rupture: Outcome of multicenter study
Giulio Massimi, Matteo Matteucci, Michele De Bonis, Mariusz Kowalewski, Francesco Formica, Claudio Francesco Russo, Sandro Sponga, Igor Vendramin, Andrea Colli, Giosuè Falcetta, Cinzia Trumella, Massimiliano Carrozzini, Theodor Fischlein, Giovanni Troise, Guglielmo Actis Dato, Stefano D'Alessandro, Peyman Sardari Nia, Vittoria Lodo, Emmanuel Villa, Shabir Hussain Shah, Roberto Scrofani, Irene Binaco, Jurij Matija Kalisnik, Matteo Pettinari, Matthias Thielmann, Bart Meyns, Fareed A Khouqeer, Carlo Fino, Caterina Simon, Paolo Severgnini, Adam Kowalowka, Marek A Deja, Daniele Ronco, Roberto Lorusso
PMID: 37039965 Abstract
Background: Post-acute myocardial infarction papillary muscle rupture (post-AMI PMR) may present variable clinical scenarios and degree of emergency due to result of cardiogenic shock. Veno-arterial extracorporeal life support (V-A ECLS) has been proposed to improve extremely poor pre- or postoperative conditions. Information in this respect is scarce.
Methods: From the CAUTION (meChanical complicAtion of acUte myocardial infarcTion: an InternatiOnal multiceNter cohort study) database (16 different Centers, data from 2001 to 2018), we extracted adult patients who were surgically treated for post-AMI PMR and underwent pre- or/and postoperative V-A ECLS support. The end-points of this study were in-hospital survival and ECLS complications.
Results: From a total of 214 post-AMI PMR patients submitted to surgery, V-A ECLS was instituted in 23 (11%) patients. The median age was 61.7 years (range 46-81 years). Preoperatively, ECLS was commenced in 10 patients (43.5%), whereas intra/postoperative in the remaining 13. The most common V-A ECLS indication was post-cardiotomy shock, followed by preoperative cardiogenic shock and cardiac arrest. The median duration of V-A ECLS was 4 days. V-A ECLS complications occurred in more than half of the patients. Overall, in-hospital mortality was 39.2% (9/23), compared to 22% (42/219) for the non-ECLS group.
Conclusions: In post-AMI PMR patients, V-A ECLS was used in almost 10% of the patients either to promote bridge to surgery or as postoperative support. Further investigations are required to better evaluate a potential for increased use and its effects of V-A ECLS in such a context based on the still high perioperative mortality.
Resuscitation. 2023 Aug:189:109862. Higher versus lower blood pressure targets after cardiac arrest: Systematic review with individual patient data meta-analysis
Ville Niemelä, Faiza Siddiqui, Koen Ameloot, Matti Reinikainen, Johannes Grand, Johanna Hästbacka, Christian Hassager, Jesper Kjaergaard, Anders Åneman, Marjaana Tiainen, Niklas Nielsen, Markus Harboe Olsen, Caroline Kamp Jorgensen, Johanne Juul Petersen, Josef Dankiewicz, Manoj Saxena, Janus C Jakobsen, Markus B Skrifvars
PMID: 37295549 Abstract
Purpose: Guidelines recommend targeting mean arterial pressure (MAP) > 65 mmHg in patients after cardiac arrest (CA). Recent trials have studied the effects of targeting a higher MAP as compared to a lower MAP after CA. We performed a systematic review and individual patient data meta-analysis to investigate the effects of higher versus lower MAP targets on patient outcome.
Method: We searched the Cochrane Central Register of Controlled Trials, MEDLINE, Embase, LILACS, BIOSIS, CINAHL, Scopus, the Web of Science Core Collection, ClinicalTrials.gov, the World Health Organization International Clinical Trials Registry, Google Scholar and the Turning Research into Practice database to identify trials randomizing patients to higher (≥71 mmHg) or lower (≤70 mmHg) MAP targets after CA and resuscitation. We used the Cochrane Risk of Bias tool, version 2 (RoB 2) to assess for risk of bias. The primary outcomes were 180-day all-cause mortality and poor neurologic recovery defined by a modified Rankin score of 4-6 or a cerebral performance category score of 3-5.
Results: Four eligible clinical trials were identified, randomizing a total of 1,087 patients. All the included trials were assessed as having a low risk for bias. The risk ratio (RR) with 95% confidence interval for 180-day all-cause mortality for a higher versus a lower MAP target was 1.08 (0.92-1.26) and for poor neurologic recovery 1.01 (0.86-1.19). Trial sequential analysis showed that a 25% or higher treatment effect, i.e., RR 0.75, can be excluded. No difference in serious adverse events was found between the higher and lower MAP groups.
Conclusions: Targeting a higher MAP compared to a lower MAP is unlikely to reduce mortality or improve neurologic recovery after CA. Only a large treatment effect above 25% (RR 0.75) could be excluded, and future studies are needed to investigate if relevant but lower treatment effect exists. Targeting a higher MAP was not associated with any increase in adverse effects.
EuroIntervention. 2023 Aug 7;19(5):e414-e422. A new resorbable magnesium scaffold for de novo coronary lesions (DREAMS 3): one-year results of the BIOMAG-I first-in-human study
Michael Haude, Adrian Wlodarczak, René J van der Schaaf, Jan Torzewski, Bert Ferdinande, Javier Escaned, Juan F Iglesias, Johan Bennett, Gabor G Toth, Michael Joner, Ralph Toelg, Marcus Wiemer, Göran Olivecrano, Paul Vermeersch, Hector M Garcia-Garcia, Ron Waksman
PMID: 37334655 Abstract
Background: The third-generation coronary sirolimus-eluting magnesium scaffold, DREAMS 3G, is a further development of the DREAMS 2G (commercial name Magmaris), aiming to provide performance outcomes similar to drug-eluting stents (DES).
Aims: The BIOMAG-I study aims to assess the safety and performance of this new-generation scaffold.
Methods: This is a prospective, multicentre, first-in-human study with clinical and imaging follow-up scheduled at 6 and 12 months. The clinical follow-up will continue for 5 years.
Results: A total of 116 patients with 117 lesions were enrolled. At 12 months, after completion of resorption, in-scaffold late lumen loss was 0.24±0.36 mm (median 0.19, interquartile range 0.06-0.36). The minimum lumen area was 4.95±2.24 mm² by intravascular ultrasound and 4.68±2.32 mm² by optical coherence tomography. Three target lesion failures were reported (2.6%, 95% confidence interval: 0.9-7.9), all clinically driven target lesion revascularisations. Cardiac death, target vessel myocardial infarction and definite or probable scaffold thrombosis were absent.
Conclusions: Data at the end of the resorption period of DREAMS 3G showed that the third-generation bioresorbable magnesium scaffold is clinically safe and effective, making it a possible alternative to DES.
Eur J Surg Oncol. 2023 Aug;49(8):1489-1494. Peritoneal metastasis of advanced epithelial ovarian carcinoma treated with cytoreductive surgery and hyperthermic intraperitoneal chemotherapy: A retrospective international multicentric data analysis
Bahar Canbay Torun, Olivier Glehen, Vahan Kepenekian, Armando Sardi, Alvaro Arjona-Sanchez, Yutaka Yonemura, Shoma Barat, David Morris, John Spiliotis, Federico Coccolini, Antonio Sommariva, Adrian Bartos, Sayyed Raza, Kurt Vander Speteen, Levhi Akin, Tulay Irez, Emel Canbay; Multicenter International PMOC Group of PSOGI
PMID: 37085403 Abstract
Introduction: The purpose of our study was to evaluate outcome data after cytoreductive surgery (CRS) and hyperthermic intraperitoneal chemotherapy (HIPEC) in patients with peritoneal metastasis originating from advanced epithelial ovarian carcinoma (PMOC).
Patients and methods: A retrospective international multi-institutional registry was established through collaborative efforts of participating units affiliated with the Peritoneal Surface Oncology Group.
Results: One thousand four hundred and ninety-one patients from 11 specialized units underwent CRS and HIPEC that of those 326 (21.9%) upfront surgeries, 504 (33.8%) interval surgery, and 661(44.3%) recurrent cases. Complete Cytoreduction(CC0/1) was achieved in 1213 patients (81.3%). Treatment -related mortality was 0.8%, major operative complications (Grades 3-5) was 25.1%. Factors associated with major operative complications include prior surgical score (PSS for recurrent cases; RC) PSS>2,p = 0.000), PCI(≤15, >15 cut-off level; p ≤ 0.000), completeness of cytoreduction (CC, p=0.000), high CA125 levels (>25 mg/dl), presence of ascites, high CRP (>5 mg/dl) levels and low albumin levels (below to 2.5 mg/dl) (p ≤ 0.05). The median survival was 58 months in upfront surgery(UFS), 60 months in interval surgery(IS), and 42 months in RC. The overall survival for five years was 45% for UFS, 37% for IS, 28% for RC cases. CCscore (p = 0.000), CA125, CRP and albumin levels (p ≤ 0.05) were predictors for progression free survival. PCI(p ≤ 0.000), major postoperative complications (p = 0.004), incomplete CRS(CC2/3)(p 0.001), prior chemotherapy (hazard ratio [HR], 3-8; p 0.001) and PSS>2 for RC were independent predictors of poor overall survival.
Conclusion: The combined treatment strategy for PMOC may be performed safely with acceptable morbidity and mortality in the specialized units.
Resuscitation. 2023 Aug:189:109886. Blood pressure targets and management during post-cardiac arrest care
Markus B Skrifvars, Koen Ameloot, Anders Åneman
PMID: 37380065 Abstract
Blood pressure is one modifiable physiological target in patients treated in the intensive care unit after cardiac arrest. Current Guidelines recommend targeting a mean arterial pressure (MAP) of higher than 65-70 mmHg using fluid resuscitation and the use of vasopressors. Management strategies will vary based in the setting, i.e. the pre-hospital compared to the in-hospital phase. Epidemiological data suggest that some degree of hypotension requiring vasopressors occur in almost 50% of patients. A higher MAP could theoretically increase coronary blood flow but on the other hand the use of vasopressor may result in an increase in cardiac oxygen demand and arrhythmia. An adequate MAP is paramount for maintaining cerebral blood flow. In some cardiac arrest patients the cerebral autoregulation may be disturbed resulting in the need for higher MAP in order to avoid decreasing cerebral blood flow. Thus far, four studies including little more than 1000 patients have compared a lower and higher MAP target in cardiac arrest patients. The achieved mean difference of MAP between groups has varied from 10-15 mmHg. Based on these studies a Bayesian meta-analysis suggests that the posterior probability that a future study would find treatment effects higher than a 5% difference between groups to be less than 50%. On the other hand, this analysis also suggests, that the likelihood of harm with a higher MAP target is also low. Noteworthy is that all studies to date have focused mainly on patients with a cardiac cause of the arrest with the majority of patients being resuscitated from a shockable initial rhythm. Future studies should aim to include also non-cardiac causes and aim to target a wider separation in MAP between groups.
Circ Cardiovasc Interv. 2023 Aug;16(8):e013009. Vascular Access in Percutaneous Coronary Intervention of Chronic Total Occlusions: A State-of-the-Art Review
Thomas A Meijers, Adel Aminian, Marco Valgimigli, Joseph Dens, Pierfrancesco Agostoni, Juan F Iglesias, Gabriele L Gasparini, Arnold H Seto, Shigeru Saito, Sunil V Rao, Niels van Royen, Emmanouil S Brilakis, Maarten A H van Leeuwen
PMID: 37458110 Abstract
The outcomes of chronic total occlusion percutaneous coronary intervention have considerably improved during the last decade with continued emphasis on improving procedural safety. Vascular access site bleeding remains one of the most frequent complications. Several procedural strategies have been implemented to reduce the rate of vascular access site complications. This state-of-the-art review summarizes and describes the current evidence on optimal vascular access strategies for chronic total occlusion percutaneous coronary intervention.
JACC Clin Electrophysiol. 2023 Aug;9(8 Pt 3):1771-1782. Detecting Paroxysmal Atrial Fibrillation From an Electrocardiogram in Sinus Rhythm: External Validation of the AI Approach
Henri Gruwez, Myrte Barthels, Peter Haemers, Frederik H Verbrugge, Sebastiaan Dhont, Evelyne Meekers, Femke Wouters, Dieter Nuyens, Laurent Pison, Pieter Vandervoort, Noëlla Pierlet
PMID: 37354171 Abstract
Background: Atrial fibrillation (AF) may occur asymptomatically and can be diagnosed only with electrocardiography (ECG) while the arrhythmia is present.
Objectives: The aim of this study was to independently validate the approach of using artificial intelligence (AI) to identify underlying paroxysmal AF from a 12-lead ECG in sinus rhythm (SR).
Methods: An AI algorithm was trained to identify patients with underlying paroxysmal AF, using electrocardiographic data from all in- and outpatients from a single center with at least 1 ECG in SR. For patients without AF, all ECGs in SR were included. For patients with AF, all ECGs in SR starting 31 days before the first AF event were included. The patients were randomly allocated to training, internal validation, and testing datasets in a 7:1:2 ratio. In a secondary analysis, the AF prevalence of the testing group was modified. Additionally, the performance of the algorithm was validated at an external hospital.
Results: The dataset consisted of 494,042 ECGs in SR from 142,310 patients. Testing the model on the first ECG of each patient (AF prevalence 9.0%) resulted in accuracy of 78.1% (95% CI: 77.6%-78.5%), area under the receiver-operating characteristic curve of 0.87 (95% CI: 0.86-0.87), and area under the precision recall curve (AUPRC) of 0.48 (95% CI: 0.46-0.50). In a low-risk group (AF prevalence 3%), the AUPRC decreased to 0.21 (95% CI: 0.18-0.24). In a high-risk group (AF prevalence 30%), the AUPRC increased to 0.76 (95% CI: 0.75-0.78). This performance was robust when validated in an external hospital.
Conclusions: The approach of using an AI-enabled electrocardiographic algorithm for the identification of patients with underlying paroxysmal AF from ECGs in SR was independently validated.
Knee. 2023 Aug:43:51-61. The effect of weight-bearing positions on coronal lower limb alignment: A systematic review
William Colyn, Lukas Vanbecelaere, Liesbeth Bruckers, Lennart Scheys, Johan Bellemans
PMID: 37271072 Abstract
Background: The coronal alignment of the lower limb is generally accepted as a major determinant of surgical outcome in total knee arthroplasty (TKA). To achieve the ideal post-operative alignment, surgeons need to be aware of the influence that weight-bearing positions have on the final knee alignment. Therefore, this review aims to define the effect of varying weight-bearing positions on the coronal alignment of the lower limb. We hypothesized that a coronal alignment deformity increases with loading.
Methods: The PubMed, Medline and google scholar databases were searched systematically in June 2022. Only studies which compared coronal alignment with a standardized radiographic protocol in the single leg, double leg and supine positions were included. To obtain pooled estimates of the effect of different weight-bearing positions, random-effect analysis were fitted using SAS.
Results: Compared to the supine position, double leg weight-bearing positions were found to be associated with a more pronounced varus deformity (mean difference in HKA is 1,76° (95% CI 1,32: 2,21), p 0.0001)). The mean difference in HKA between double leg and single leg weight-bearing conditions was 1.43° (95% CI (-0,042;2,90), p = 0.0528).
Conclusion: The overall knee alignment was found to be influenced by the weight-bearing position. An average difference of 1.76° in HKA-angle was found between a double leg-stance and supine position, tending to increased varus in the former weight-bearing position. It is therefore possible that the deformity could increase by 1.76° if knee surgeons only follow a pre-op planning based on double-leg stance full length radiographs.
Eur Heart J Cardiovasc Imaging. 2023 Aug 23;24(9):e275. When therapy becomes the source of embolism Sebastiaan Dhont, Herbert Gutermann, Johan Van Lierde, Peter Verbrugghe, Pieter M Vandervoort
PMID: 37282667
No abstract available
Ann Neurol. 2023 Aug 22. GABRA1-Related Disorders: From Genetic to Functional Pathways
Elisa Musto, Vivian W Y Liao, Katrine M Johannesen, Christina D Fenger, Damien Lederer, Kavitha Kothur, Katrina Fisk, Bruce Bennetts, Pascal Vrielynck, Delphine Delaby, Berten Ceulemans, Sarah Weckhuysen, Peter Sparber, Arjan Bouman, Simone Ardern-Holmes, Christopher Troedson, Domenica I Battaglia, Himanshu Goel, Timothy Feyma, Somayeh Bakhtiari, Linda Tjoa, Martin Boxill, Nina Demina, Olga Shchagina, Elena Dadali, Michael Kruer, Gaetano Cantalupo, Ilaria Contaldo, Tilman Polster, Bertrand Isidor, Stefania M Bova, Walid Fazeli, Leen Wouters, Maria J Miranda, Francesca Darra, Elisa Pede, Diana Le Duc, Rami Abou Jamra, Sébastien Küry, Jacopo Proietti, Niamh McSweeney, Elly Brokamp, Peter Ian Andrews, Marie Gouray Garcia, Mary Chebib, Rikke S Møller, Philip K Ahring, Elena Gardella
PMID: 37606373 Abstract
Objective: Variants in GABRA1 have been associated with a broad epilepsy spectrum, ranging from genetic generalized epilepsies to developmental and epileptic encephalopathies. However, our understanding of what determines the phenotype severity and best treatment options remains inadequate. We therefore aimed to analyze the electroclinical features and the functional effects of GABRA1 variants to establish genotype-phenotype correlations.
Methods: Genetic and electroclinical data of 27 individuals (22 unrelated and 2 families) harboring 20 different GABRA1 variants were collected and accompanied by functional analysis of 19 variants.
Results: Individuals in this cohort could be assigned into different clinical subgroups based on the functional effect of their variant and its structural position within the GABRA1 subunit. A homogenous phenotype with mild cognitive impairment and infantile onset epilepsy (focal seizures, fever sensitivity, and electroencephalographic posterior epileptiform discharges) was described for variants in the extracellular domain and the small transmembrane loops. These variants displayed loss-of-function (LoF) effects, and the patients generally had a favorable outcome. A more severe phenotype was associated with variants in the pore-forming transmembrane helices. These variants displayed either gain-of-function (GoF) or LoF effects. GoF variants were associated with severe early onset neurodevelopmental disorders, including early infantile developmental and epileptic encephalopathy.
Interpretation: Our data expand the genetic and phenotypic spectrum of GABRA1 epilepsies and permit delineation of specific subphenotypes for LoF and GoF variants, through the heterogeneity of phenotypes and variants. Generally, variants in the transmembrane helices cause more severe phenotypes, in particular GoF variants. These findings establish the basis for a better understanding of the pathomechanism and a precision medicine approach in GABRA1-related disorders. Further studies in larger populations are needed to provide a conclusive genotype-phenotype correlation. ANN NEUROL 2023.
J Am Soc Echocardiogr. 2023 Aug;36(8):824-831. Reduced Left Atrial Appendage Flow Is Associated With Future Atrial Fibrillation After Cryptogenic Stroke
Sebastiaan Dhont, Femke Wouters, Sébastien Deferm, Kim Bekelaar, Henri Gruwez, Evelyne Meekers, Dieter Nuyens, David Verhaert, Pieter Vandervoort, Philippe B Bertrand
PMID: 37191596 Abstract
Background: Hemostasis within the left atrial appendage (LAA) is a common cause of stroke, especially in patients with atrial fibrillation (AF). Although LAA flow provides insights into LAA function, its potential for predicting AF has yet to be established. The aim of this study was to explore whether LAA peak flow velocities early after cryptogenic stroke are associated with future AF on prolonged rhythm monitoring.
Methods: A total of 110 patients with cryptogenic stroke were consecutively enrolled and underwent LAA pulsed-wave Doppler flow assessment using transesophageal echocardiography within the early poststroke period. Velocity measurements were analyzed offline by an investigator blinded to the results. Prolonged rhythm monitoring was conducted on all participants via 7-day Holter and implantable cardiac monitoring devices, with follow-up conducted over a period of 1.5 years to determine the incidence of AF. The end point of AF was defined as irregular supraventricular rhythm with variable RR interval and no detectable P waves lasting ≥30 sec during rhythm monitoring.
Results: During a median follow-up period of 539 days (interquartile range, 169-857 days), 42 patients (38%) developed AF, with a median time to AF diagnosis of 94 days (interquartile range, 51-487 days). Both LAA filling velocity and LAA emptying velocity (LAAev) were lower in patients with AF (44.3 ± 14.2 and 50.7 ± 13.3 cm/s, respectively) compared with patients without AF (59.8 ± 14.0 and 76.8 ± 17.3 cm/sec, respectively; P .001 for both). LAAev was most strongly associated with future AF, with an area under the receiver operating characteristic curve of 0.88 and an optimal cutoff value of 55 cm/sec. Age and mitral regurgitation were independent determinants of reduced LAAev.
Conclusions: Impaired LAA peak flow velocities (LAAev 55 cm/sec) in patients with cryptogenic stroke are associated with future AF. This may facilitate the selection of appropriate candidates for prolonged rhythm monitoring to improve its diagnostic accuracy and implementation.
Eur J Trauma Emerg Surg. 2023 Aug;49(4):1791-1801. Interinstitutional analysis of the outcome after surgery for type A aortic dissection
Fausto Biancari, Angelo M Dell'Aquila, Giuseppe Gatti, Andrea Perrotti, Amélie Hervé, Joseph Touma, Matteo Pettinari, Sven Peterss, Joscha Buech, Konrad Wisniewski, Tatu Juvonen, Mikko Jormalainen, Caius Mustonen, Andreas Rukosujew, Till Demal, Lenard Conradi, Marek Pol, Petr Kacer, Francesco Onorati, Cecilia Rossetti, Igor Vendramin, Daniela Piani, Mauro Rinaldi, Luisa Ferrante, Eduard Quintana, Robert Pruna-Guillen, Javier Rodriguez Lega, Angel G Pinto, Metesh Acharya, Zein El-Dean, Mark Field, Amer Harky, Manoj Kuduvalli, Francesco Nappi, Sebastien Gerelli, Dario Di Perna, Enzo Mazzaro, Stefano Rosato, Antonio Fiore, Giovanni Mariscalco
PMID: 36826589 Abstract
Purpose: To evaluate the impact of individual institutions on the outcome after surgery for Stanford type A aortic dissection (TAAD).
Methods: This is an observational, multicenter, retrospective cohort study including 3902 patients who underwent surgery for TAAD at 18 university and non-university hospitals.
Results: Logistic regression showed that four hospitals had increased risk of in-hospital mortality, while two hospitals were associated with decreased risk of in-hospital mortality. Risk-adjusted in-hospital mortality rates were lower in four hospitals and higher in other four hospitals compared to the overall in-hospital mortality rate (17.7%). Participating hospitals were classified as overperforming or underperforming if their risk-adjusted in-hospital mortality rate was lower or higher than the in-hospital mortality rate of the overall series, respectively. Propensity score matching yielded 1729 pairs of patients operated at over- or underperforming hospitals. Overperforming hospitals had a significantly lower in-hospital mortality (12.8% vs. 22.2%, p 0.0001) along with decreased rate of stroke and/or global brain ischemia (16.5% vs. 19.9%, p = 0.009) compared to underperforming hospitals. Aggregate data meta-regression of the results of participating hospitals showed that hospital volume was inversely associated with in-hospital mortality (p = 0.043). Hospitals with an annual volume of less than 15 cases had an increased risk of in-hospital mortality (adjusted OR, 1.345, 95% CI 1.126-1.607).
Conclusion: The present findings indicate that there are significant differences between hospitals in terms of early outcome after surgery for TAAD. Low hospital volume may be a determinant of poor outcome of TAAD.
Heart Rhythm. 2023 Sep;20(9):e17-e91. 2023 HRS/APHRS/LAHRS guideline on cardiac physiologic pacing for the avoidance and mitigation of heart failure
Mina K Chung, Kristen K Patton, Chu-Pak Lau, Alexander R J Dal Forno, Sana M Al-Khatib, Vanita Arora, Ulrika Maria Birgersdotter-Green, Yong-Mei Cha, Eugene H Chung, Edmond M Cronin, Anne B Curtis, Iwona Cygankiewicz, Gopi Dandamudi, Anne M Dubin, Douglas P Ensch, Taya V Glotzer, Michael R Gold, Zachary D Goldberger, Rakesh Gopinathannair, Eiran Z Gorodeski, Alejandra Gutierrez, Juan C Guzman, Weijian Huang, Peter B Imrey, Julia H Indik, Saima Karim, Peter P Karpawich, Yaariv Khaykin, Erich L Kiehl, Jordana Kron, Valentina Kutyifa, Mark S Link, Joseph E Marine, Wilfried Mullens, Seung-Jung Park, Ratika Parkash, Manuel F Patete, Rajeev Kumar Pathak, Carlos A Perona, John Rickard, Mark H Schoenfeld, Swee-Chong Seow, Win-Kuang Shen, Morio Shoda, Jagmeet P Singh, David J Slotwiner, Arun Raghav M Sridhar, Uma N Srivatsa, Eric C Stecker, Tanyanan Tanawuttiwat, W H Wilson Tang, Carlos Andres Tapias, Cynthia M Tracy, Gaurav A Upadhyay, Niraj Varma, Kevin Vernooy, Pugazhendhi Vijayaraman, Sarah Ann Worsnick, Wojciech Zareba, Emily P Zeitler
PMID: 37283271 Abstract
Cardiac physiologic pacing (CPP), encompassing cardiac resynchronization therapy (CRT) and conduction system pacing (CSP), has emerged as a pacing therapy strategy that may mitigate or prevent the development of heart failure (HF) in patients with ventricular dyssynchrony or pacing-induced cardiomyopathy. This clinical practice guideline is intended to provide guidance on indications for CRT for HF therapy and CPP in patients with pacemaker indications or HF, patient selection, pre-procedure evaluation and preparation, implant procedure management, follow-up evaluation and optimization of CPP response, and use in pediatric populations. Gaps in knowledge, pointing to new directions for future research, are also identified.
Eur J Heart Fail. 2023 Sep;25(9):1571-1583. Hyponatraemia and changes in natraemia during hospitalization for acute heart failure and associations with in-hospital and long-term outcomes - from the ESC-HFA EORP Heart Failure Long-Term Registry
Agnieszka Kapłon-Cieślicka, Lina Benson, Ovidiu Chioncel, Maria G Crespo-Leiro, Andrew J S Coats, Stefan D Anker, Frank Ruschitzka, Camilla Hage, Jarosław Drożdż, Petar Seferovic, Giuseppe M C Rosano, Massimo Piepoli, Alexandre Mebazaa, Theresa McDonagh, Mitja Lainscak, Gianluigi Savarese, Roberto Ferrari, Wilfried Mullens, Antoni Bayes-Genis, Aldo P Maggioni, Lars H Lund; on behalf of the Heart Failure Association (HFA) of the European Society of Cardiology (ESC) and the ESC Heart Failure Long-Term Registry Investigators
PMID: 37114294 Abstract
Aims: To comprehensively assess hyponatraemia in acute heart failure (AHF) regarding prevalence, associations, hospital course, and post-discharge outcomes.
Methods and results: Of 8298 patients in the European Society of Cardiology Heart Failure Long-Term Registry hospitalized for AHF with any ejection fraction, 20% presented with hyponatraemia (serum sodium 135 mmol/L). Independent predictors included lower systolic blood pressure, estimated glomerular filtration rate (eGFR) and haemoglobin, along with diabetes, hepatic disease, use of thiazide diuretics, mineralocorticoid receptor antagonists, digoxin, higher doses of loop diuretics, and non-use of angiotensin-converting enzyme inhibitors/angiotensin receptor blockers and beta-blockers. In-hospital death occurred in 3.3%. The prevalence of hyponatraemia and in-hospital mortality with different combinations were: 9% hyponatraemia both at admission and discharge (hyponatraemia Yes/Yes, in-hospital mortality 6.9%), 11% Yes/No (in-hospital mortality 4.9%), 8% No/Yes (in-hospital mortality 4.7%), and 72% No/No (in-hospital mortality 2.4%). Correction of hyponatraemia was associated with improvement in eGFR. In-hospital development of hyponatraemia was associated with greater diuretic use and worsening eGFR but also more effective decongestion. Among hospital survivors, 12-month mortality was 19% and adjusted hazard ratios (95% confidence intervals) were for hyponatraemia Yes/Yes 1.60 (1.35-1.89), Yes/No 1.35 (1.14-1.59), and No/Yes 1.18 (0.96-1.45). For death or heart failure hospitalization they were 1.38 (1.21-1.58), 1.17 (1.02-1.33), and 1.09 (0.93-1.27), respectively.
Conclusion: Among patients with AHF, 20% had hyponatraemia at admission, which was associated with more advanced heart failure and normalized in half of patients during hospitalization. Admission hyponatraemia (possibly dilutional), especially if it did not resolve, was associated with worse in-hospital and post-discharge outcomes. Hyponatraemia developing during hospitalization (possibly depletional) was associated with lower risk.
Circulation. 2023 Sep 26;148(13):989-999. Biodegradable-Polymer or Durable-Polymer Stents in Patients at High Bleeding Risk: A Randomized, Open-Label Clinical Trial
Marco Valgimigli, Adrian Wlodarczak, Ralph Tölg, Béla Merkely, Henning Kelbæk, Jacek Legutko, Stefano Galli, Matthieu Godin, Gabor G Toth, Thibault Lhermusier, Benjamin Honton, Peter Laurenz Dietrich, Francis Stammen, Bert Ferdinande, Johanne Silvain, Davide Capodanno, Guillaume Cayla; Bioflow-DAPT Investigators
PMID: 37624364 Abstract
Background: Limited information is available on the comparative efficacy and safety of different stent platforms in patients at high bleeding risk undergoing an abbreviated dual antiplatelet therapy duration after percutaneous coronary intervention (PCI). The aim of this study was to compare the safety and effectiveness of the biodegradable-polymer sirolimus-eluting stent with the durable-polymer zotarolimus-eluting stent in patients at high bleeding risk receiving 1 month of dual antiplatelet therapy after PCI.
Methods: The Bioflow-DAPT Study is an international, randomized, open-label trial conducted at 52 interventional cardiology hospitals in 18 countries from February 24, 2020, through September 20, 2021. Patients with a clinical indication to PCI because of acute or chronic coronary syndrome who fulfilled 1 or more criteria for high bleeding risk were eligible for enrollment. Patients were randomized to receive either biodegradable-polymer sirolimus-eluting stents or durable-polymer, slow-release zotarolimus-eluting stents after successful lesion preparation, followed by 1 month of dual antiplatelet therapy and thereafter single antiplatelet therapy. The primary outcome was the composite of death from cardiac causes, myocardial infarction, or stent thrombosis at 1 year, and was powered for noninferiority, with an absolute margin of 4.1% at 1-sided 5% alpha.
Results: A total of 1948 patients at high bleeding risk were randomly assigned (1:1) to receive biodegradable-polymer sirolimus-eluting stents (969 patients) or durable-polymer zotarolimus-eluting stents (979 patients). At 1 year, the primary outcome was observed in 33 of 969 patients (3.6%) in the biodegradable-polymer sirolimus-eluting stent group and in 32 of 979 patients (3.4%) in the durable-polymer zotarolimus-eluting stent group (risk difference, 0.2 percentage points; upper boundary of the 1-sided 95% CI, 1.8; upper boundary of the 1-sided 97.5% CI, 2.1; P0.0001 for noninferiority for both tests).
Conclusions: Among patients at high risk for bleeding who received 1 month of dual antiplatelet therapy after PCI, the use of biodegradable-polymer sirolimus-eluting stents was noninferior to the use of durable-polymer zotarolimus-eluting stents with regard to the composite of death from cardiac causes, myocardial infarction, or stent thrombosis.
Am J Emerg Med. 2023 Sep:71:251. Corrigendum to "Hyperkalemia in acute heart failure: Short term outcomes from the EAHFE registry" [American Journal of Emergency Medicine, 70C (2023) 1-9]
Zubaid Rafique, Maria José Fortuny, Dick Kuo, Lukasz Szarpak, Lluís Llauger, Begoña Espinosa, Víctor Gil, Javier Jacob, Aitor Alquézar-Arbé, Juan Antonio Andueza, José Manuel Garrido, Alfons Aguirre, Marta Fuentes, Héctor Alonso, Francisco Javier Lucas-Imbernón, Carlos Bibiano, Guillermo Burillo-Putze, Julio Núñez, Wilfried Mullens, Pedro Lopez-Ayala, Christian Mueller, Pere Llorens, Frank Peacock, Òscar Miró; ICA-SEMES Research Group
PMID: 37268493
No abstract available
Eur J Heart Fail. 2023 Sep;25(9):1555-1570. Decongestion strategies in patients presenting with acutely decompensated heart failure: A worldwide survey among physicians
Ali Vazir, Chris J Kapelios, Elif Agaoglu, Marco Metra, Yury Lopatin, Petar Seferovic, Wilfried Mullens, Gerasimos Filippatos, Giuseppe Rosano, Andrew J S Coats, Ovidiu Chioncel
PMID: 37565377 Abstract
Aims: Decongestion strategies for acute decompensated heart failure (ADHF) characterized by volume overload differ widely. The aim of this independent international academic web-based survey was to capture the therapeutic strategies that physicians use to treat ADHF and to assess differences in therapeutic approaches between cardiologists versus non-cardiologists.
Methods and results: Physicians were invited to complete a web-based questionnaire, capturing anonymized data on physicians' characteristics and treatment preferences based on a hypothetical clinical scenario of a patient hospitalized with ADHF. A total of 641 physicians from 60 countries participated. A wide variation in the management of the patient was observed. There was conservative use of diuretics, i.e. only 7% started intravenous furosemide at a dose ≥2 times the baseline oral dose, and infrequent use of ultrasound in assessing congestion (20.4%). Spot urinary sodium was infrequently or never measured by ≥85% of physicians. A third considered a patient with ongoing oedema as being stabilized. There were significant differences between cardiologists and non-cardiologists in the management of ADHF, the targets for daily body weight loss and urine output, diuretic escalation strategies (66.3% vs. 40.7% would escalate diuresis by adding a thiazide) and assessment of response to treatment (27.0% vs. 52.9% considered patients with minimal congestion as stabilized).
Conclusions: There is substantial variability amongst physicians and between cardiologists and non-cardiologists in the management of patients with ADHF, with regard to clinical parameters used to tailor treatment, treatment goals, diuretic dosing and escalation strategies.
Pain Pract. 2023 Sep;23(7):800-817. 2. Cervical radicular pain Laurens Peene, Steven P Cohen, Brigitte Brouwer, Rathmell James, Andre Wolff, Koen Van Boxem, Jan Van Zundert
PMID: 37272250 Abstract
Introduction: Cervical radicular pain is pain perceived in the upper limb, caused by irritation or compression of a cervical spine nerve, the roots of the nerve, or both.
Methods: The literature on the diagnosis and treatment of cervical radicular pain was retrieved and summarized.
Results: The diagnosis is made by combining elements from the patient's history, physical examination, and supplementary tests. The Spurling and shoulder abduction tests are the two most common examinations used to identify cervical radicular pain. MRI without contrast, CT scanning, and in some cases plain radiography can all be appropriate imaging techniques for nontraumatic cervical radiculopathy. MRI is recommended prior to interventional treatments. Exercise with or without other treatments can be beneficial. There is scant evidence for the use of paracetamol, nonsteroidal anti-inflammatory drugs, and neuropathic pain medications such as gabapentin, pregabalin, tricyclic antidepressants, and anticonvulsants for the treatment of radicular pain. Acute and subacute cervical radicular pain may respond well to epidural corticosteroid administration, preferentially using an interlaminar approach. By contrast, for chronic cervical radicular pain, the efficacy of epidural corticosteroid administration is limited. In these patients, pulsed radiofrequency treatment adjacent to the dorsal root ganglion may be considered.
Conclusions: There is currently no gold standard for the diagnosis of cervical radicular pain. There is scant evidence for the use of medication. Epidural corticosteroid injection and pulsed radiofrequency adjacent to the dorsal root ganglion may be considered. [Correction added on 12 June 2023, after first online publication: The preceding sentence was corrected.].
N Engl J Med. 2023 Sep 14;389(11):1041-1042. Treating Iron Deficiency in Heart Failure Pieter Martens, Wilfried Mullens
PMID: 37632465
No abstract available
Clin Kidney J. 2023 Sep 1;16(11):1709-1713. Proton pump inhibitors and adverse kidney outcomes during immune checkpoint blockade: time to sound the alarm?
Hui Zhuan Tan, Ben Sprangers
PMID: 37915924 Abstract
Immune checkpoint inhibitors (ICIs) have significantly altered the treatment landscape for cancer in the last decade. However, their benefits are often offset by therapy-limiting immune-related adverse events (irAEs). Acute interstitial nephritis (AIN) is the most common renal irAE, but the exact mechanisms underlying its development are poorly understood. ICI-induced immune activation against drug-derived antigens, leading to an inflammatory response within the kidney interstitium, has been postulated, evidenced by current observations of a higher incidence of ICI-associated AIN in patients receiving AIN-inducing drugs such as proton pump inhibitors (PPIs). The role of PPIs in this specific context has garnered significant attention, given their ubiquitous use and sometimes misuse. In this issue of CKJ Miao et al. summarise and synthesize the best available evidence to clarify the interactions of PPIs with ICIs in the development of AIN and other adverse kidney outcomes. The sum of evidence provided appear to implicate PPIs in the development of clinically significant short- and long-term kidney-related adverse effects in patients on immune checkpoint blockade, although causality cannot be proven. In this editorial we discuss the key practical implications of these findings and emphasize the need for further quality studies to delineate the true relationship of ICIs and PPIs in the development of AIN.
World J Surg. 2023 Sep;47(9):2241-2249. Robotic Versus Laparoscopic Hepatectomy: A Single Surgeon Experience of 629 Consecutive Minimally Invasive Liver Resections
Thomas Winckelmans, Dennis A Wicherts, Isabelle Parmentier, Celine De Meyere, Chris Verslype, Mathieu D'Hondt
PMID: 37208537 Abstract
Background: Robotic surgery has the potential to broaden the indications for minimally invasive liver surgery owing to its technical advantages. This paper compares our experience with robotic liver surgery (RLS) with conventional laparoscopic liver surgery (LLS).
Methods: All consecutive liver resections between October 2011 and October 2022 were selected from our prospective database to be included in this cohort study. Patients who underwent RLS were compared with a LLS group for operative and postoperative outcomes.
Results: In total, 629 patients were selected from our database, including 177 patients who underwent a RLS and 452 patients who had LLS. Colorectal liver metastasis was the main indication for surgery in both groups. With the introduction of RLS, the percentage of open resections decreased significantly (32.6% from 2011 to 2020 vs. 11.5% from 2020 onward, P 0.001). In the robotic group, redo liver surgery was more frequent (24.3% vs. 16.8%, P = 0.031) and the Southampton difficulty score was higher (4 [IQR 4 to 7] vs. 4 [IQR 3 to 6], P = 0.02). Median blood loss was lower (30 vs. 100 ml, P 0.001), and postoperative length of stay (LOS) was shorter in the robotic group (median 3 vs. 4 days, P 0.001). There was no significant difference in postoperative complications. Cost related to the used instruments and LOS was significantly lower in the RLS group (median €1483 vs. €1796, P 0.001 and €1218 vs. €1624, P 0.001, respectively), while cost related to operative time was higher (median €2755 vs. €2470, P 0.001).
Conclusions: RLS may allow for a higher percentage of liver resections to be completed in a minimally invasive way with lower blood loss and a shorter LOS.
Nat Med. 2023 Sep;29(9):2206-2215. Cell-free DNA methylome analysis for early preeclampsia prediction
Marie De Borre, Huiwen Che, Qian Yu, Lore Lannoo, Kobe De Ridder, Leen Vancoillie, Pauline Dreesen, Mika Van Den Ackerveken, Mio Aerden, Eva Galle, Jeroen Breckpot, Joachim Van Keirsbilck, Wilfried Gyselaers, Koen Devriendt, Joris Robert Vermeesch, Kristel Van Calsteren, Bernard Thienpont
PMID: 37640858 Abstract
Preeclampsia (PE) is a leading cause for peripartal morbidity, especially if developing early in gestation. To enable prophylaxis in the prevention of PE, pregnancies at risk of PE must be identified early-in the first trimester. To identify at-risk pregnancies we profiled methylomes of plasma-derived, cell-free DNA from 498 pregnant women, of whom about one-third developed early-onset PE. We detected DNA methylation differences between control and PE pregnancies that enabled risk stratification at PE diagnosis but also presymptomatically, at around 12 weeks of gestation (range 9-14 weeks). The first-trimester risk prediction model was validated in an external cohort collected from two centers (area under the curve (AUC) = 0.75) and integrated with routinely available maternal risk factors (AUC = 0.85). The combined risk score correctly predicted 72% of patients with early-onset PE at 80% specificity. These preliminary results suggest that cell-free DNA methylation profiling is a promising tool for presymptomatic PE risk assessment, and has the potential to improve treatment and follow-up in the obstetric clinic.
Acta Gastroenterol Belg. 2023 Jul-Sep;86(3):483-485. Biliary papillomatosis
F Gelders, M Struyve, H van Malenstein
PMID: 37814564 Abstract
Biliary papillomatosis (BP) is a rare disorder of the biliary tract characterized by the presence of multiple papillary adenomas spread along the biliary tree. Although benign, it carries a significant risk of malignant transformation. Due to low sensitivity and specificity of conventional radiologic modalities, the diagnosis as well as estimation of disease extent is difficult. Endoscopic ultrasound (EUS) and endoscopic retrograde cholangiopancreaticography (ERCP) are superior although direct peroral cholangioscopy (POC) is currently the most accurate diagnostic method. Mainly because it provides more detailed information and makes targeted histological diagnosis possible. The treatment of biliary papillomatosis consists of surgical resection, liver transplantation (LT) or a combination of both. Unfortunately, the recurrence rate after radical surgery without LT remains high due to the diffuse distribution of the disease.
Eur J Cardiothorac Surg. 2023 Sep 7;64(3):ezad282. Reply to Waller et al
Alessandro Brunelli, Herbert Decaluwe, Michel Gonzalez, Dominique Gossot, Rene Horsleben Petersen
PMID: 37632779
No abstract available
J Med Internet Res. 2023 Sep 6:25:e42686. Changes in Intrapersonal Factors of Participants in the Pregnancy Remote Monitoring Study Who Are at Risk for Pregnancy-Induced Hypertension: Descriptive Quantitative Study Dorien Lanssens, Thijs Vandenberk, Valerie Storms, Inge Thijs, Lars Grieten, Lotte Bamelis, Wilfried Gyselaers, Eileen Tang, Patrick Luyten
PMID: 37672324 Abstract
Background: The peripartum period, defined as the period from the beginning of the gestation until 1 year after the delivery, has long been shown to be potentially associated with increased levels of stress and anxiety with regard to one's transition to the status of parent and the accompanying parental tasks. Yet, no research to date has investigated changes in intrapersonal factors during the peripartum period in women at risk for pregnancy-induced hypertension (PIH).
Objective: The aim of this study is to explore and describe changes in intrapersonal factors in participants at risk for PIH.
Methods: We used an explorative design in which 3 questionnaires were sent by email to 110 participants the day following enrollment in the Pregnancy Remote Monitoring program for pregnant women at risk for PIH. Women were invited to complete the questionnaires at the beginning of their participation in the Pregnancy Remote Monitoring project (mostly at 14 weeks of gestation) and after approaching 32 weeks of gestational age (GA). The Generalized Anxiety Disorder-7 Scale (GAD-7) and the Patient Health Questionnaire-9 were used to assess anxiety and depression, and adaptation of the Pain Catastrophizing Scale was used to measure trait pain catastrophizing.
Results: Scores were significantly higher at 32 weeks of GA than at the moment of enrollment (GAD-7 score=7, range 4-11 vs 5, range 3-8; P=.01; and Patient Health Questionnaire-9 score=6, range 4-10 vs 4, range 2-7; P.001). The subscale scores of the Pain Catastrophizing Scale were all lower at 32 weeks of GA compared with 14 weeks of GA (rumination: 4, range 1-6 vs 5, range 2-9.5; P=.11; magnification: 3, range 1-5.5 vs 4, range 3-7; P=.04; and helplessness: 5, range 2-9 vs 6, range 3.5-12; P=.06). The proportion of women with a risk for depression (GAD-7 score >10) was 13.3% (10/75) at enrollment and had increased to 35.6% (26/75) at 32 weeks of GA.
Conclusions: This study shows that pregnant women at risk for PIH have higher levels of stress and anxiety at 32 weeks of GA than at the moment of enrollment. Further research is recommended to investigate potential strategies to help pregnant women at risk for PIH manage feelings of stress and anxiety.
Acta Orthop Belg.2023 Sep;89(3):417-422. Outcome of lateral retinacular nerve transection combined with release for recalcitrant iliotibial band friction syndrome
J Kloos, J Bellemans
PMID: 37935223 Abstract
In this retrospective study, a technique consisting in neurolysis of the lateral retinacular nerve combined with a partial release through elliptic excision of the iliotibial band (ITB) is evaluated for efficacy in recalcitrant ITB friction syndrome and compared with results from other techniques reported in literature. From April 2014 to December 2017, 21 patients suffering from recalcitrant ITB friction syndrome were surgically treated with the aforementioned technique. 15 patients (15 knees) were available for a written retrospective reassessment after completion of a follow-up period of at least 12 months. Residual pain was scored using the Visual Analogue Scale (VAS). The functional outcome was evaluated by two patient reported outcome measurement scales (PROMs), the Lysholm and the International Knee Documentation Committee (IKDC) score. Return to sport was analysed by duration of the inactivity period as well as by the Tegner score. Overall satisfaction was evaluated using a modified Boyden scale. At final follow-up of one year, the performed intervention resulted in a pain reduction (VAS 4.2 (1-8) to 1.4 (0-6)) and improved knee function (Lysholm 59.53 to 87.73, IKDC 75) with return to sport (Tegner 4.3 to 5.4) after a median of 23.8 weeks (6 to 52). Twelve patients reported good or excellent results (80%) at final follow-up, and 12 patients (80%) would undergo surgery again, if necessary. The treatment of recalcitrant ITB friction syndrome by combining neurectomy of the lateral retinacular nerve with elliptic excision of the ITB resulted in good to excellent results in 80% of treated cases with return to sport in 93%.
Lancet. 2023 Sep 30;402(10408):1147-1157. Adaptive versus conventional cardiac resynchronisation therapy in patients with heart failure (AdaptResponse): a global, prospective, randomised controlled trial
Bruce L Wilkoff, Gerasimos Filippatos, Christophe Leclercq, Michael R Gold, Ahmad S Hersi, Kengo Kusano, Wilfried Mullens, G Michael Felker, Charan Kantipudi, Mikhael F El-Chami, Vidal Essebag, Bertrand Pierre, Francois Philippon, Francisco Perez-Gil, Eugene S Chung, Juan Sotomonte, Stanley Tung, Balbir Singh, Babak Bozorgnia, Satish Goel, Hans Holger Ebert, Niraj Varma, Kara J Quan, Fiorella Salerno, Bart Gerritse, Janelle van Wel, Daniel E Schaber, Dedra H Fagan, David Birnie; AdaptResponse investigators
PMID: 37634520
Eur Heart J Digit Health. 2023 Sep 30;4(6):464-472. Smartphone-based atrial fibrillation screening in the general population: feasibility and impact on medical treatment
Henri Gruwez, Frederik H Verbrugge, Tine Proesmans, Stijn Evens, Peter Vanacker, Matthieu Pierre Rutgers, Geert Vanhooren, Philippe Bertrand,Laurent Pison, Peter Haemers, Pieter Vandervoort, Dieter Nuyens
PMID: 38045439 Abstract
Aims: The aim of this study is to determine the feasibility, detection rate, and therapeutic implications of large-scale smartphone-based screening for atrial fibrillation (AF).
Methods and results: Subjects from the general population in Belgium were recruited through a media campaign to perform AF screening during 8 consecutive days with a smartphone application. The application analyses photoplethysmography traces with artificial intelligence and offline validation of suspected signals to detect AF. The impact of AF screening on medical therapy was measured through questionnaires. Atrial fibrillation was detected in the screened population (n = 60.629) in 791 subjects (1.3%). From this group, 55% responded to the questionnaire. Clinical AF [AF confirmed on a surface electrocardiogram (ECG)] was newly diagnosed in 60 individuals and triggered the initiation of anti-thrombotic therapy in 45%, adjustment of rate or rhythm controlling strategies in 62%, and risk factor management in 17%. In subjects diagnosed with known AF before screening, a positive screening result led to these therapy adjustments in 9%, 39%, and 11%, respectively. In all subjects with clinical AF and an indication for oral anti-coagulation (OAC), OAC uptake increased from 56% to 74% with AF screening. Subjects with clinical AF were older with more co-morbidities compared with subclinical AF (no surface ECG confirmation of AF) (P 0.001). In subjects with subclinical AF (n = 202), therapy adjustments were performed in only 7%.
Conclusion: Smartphone-based AF screening is feasible at large scale. Screening increased OAC uptake and impacted therapy of both new and previously diagnosed clinical AF but failed to impact risk factor management in subjects with subclinical AF.
Heliyon. 2023 Oct 5;9(10):e20702. Preoperative arterial lactate and outcome after surgery for type A aortic dissection: The ERTAAD multicenter study
Fausto Biancari, Francesco Nappi, Giuseppe Gatti, Andrea Perrotti, Amélie Hervé, Stefano Rosato, Paola D'Errigo, Matteo Pettinari, Sven Peterss, Joscha Buech, Tatu Juvonen, Mikko Jormalainen, Caius Mustonen, Till Demal, Lenard Conradi, Marek Pol, Petr Kacer, Angelo M Dell'Aquila, Konrad Wisniewski, Igor Vendramin, Daniela Piani, Luisa Ferrante, Timo Mäkikallio, Eduard Quintana, Robert Pruna-Guillen, Antonio Fiore, Thierry Folliguet, Giovanni Mariscalco, Metesh Acharya, Mark Field, Manoj Kuduvalli, Francesco Onorati, Cecilia Rossetti, Sebastien Gerelli, Dario Di Perna, Enzo Mazzaro, Angel G Pinto, Javier Rodriguez Lega, Mauro Rinaldi Abstract
Background: Acute type A aortic dissection (TAAD) is associated with significant mortality and morbidity. In this study we evaluated the prognostic significance of preoperative arterial lactate concentration on the outcome after surgery for TAAD.
Methods: The ERTAAD registry included consecutive patients who underwent surgery for acute type A aortic dissection (TAAD) at 18 European centers of cardiac surgery.
Results: Data on arterial lactate concentration immediately before surgery were available in 2798 (71.7 %) patients. Preoperative concentration of arterial lactate was an independent predictor of in-hospital mortality (mean, 3.5 ± 3.2 vs 2.1 ± 1.8 mmol/L, adjusted OR 1.181, 95%CI 1.129-1.235). The best cutoff value preoperative arterial lactate concentration was 1.8 mmol/L (in-hospital mortality, 12.0 %, vs. 26.6 %, p 0.0001). The rates of in-hospital mortality increased along increasing quintiles of arterial lactate and it was 12.1 % in the lowest quintile and 33.6 % in the highest quintile (p 0.0001). The difference between multivariable models with and without preoperative arterial lactate was statistically significant (p = 0.0002). The NRI was 0.296 (95%CI 0.200-0.391) (p 0.0001) with -17 % of events correctly reclassified (p = 0.0002) and 46 % of non-events correctly reclassified (p 0.0001). The IDI was 0.025 (95%CI 0.016-0.034) (p 0.0001). Six studies from a systematic review plus the present one provided data for a pooled analysis which showed that the mean difference of preoperative arterial lactate between 30-day/in-hospital deaths and survivors was 1.85 mmol/L (95%CI 1.22-2.47, p 0.0001, I2 64 %).
Conclusions: Hyperlactatemia significantly increased the risk of mortality after surgery for acute TAAD and should be considered in the clinical assessment of these critically ill patients.
Eur Heart J. 2023 Oct 14;44(39):4043-4140. 2023 ESC Guidelines for the management of cardiovascular disease in patients with diabetes
Nikolaus Marx, Massimo Federici, Katharina Schütt, Dirk Müller-Wieland, Ramzi A Ajjan, Manuel J Antunes, Ruxandra M Christodorescu, Carolyn Crawford, Emanuele Di Angelantonio, Björn Eliasson, Christine Espinola-Klein, Laurent Fauchier, Martin Halle, William G Herrington, Alexandra Kautzky-Willer, Ekaterini Lambrinou, Maciej Lesiak, Maddalena Lettino, Darren K McGuire, Wilfried Mullens, Bianca Rocca, Naveed Sattar; ESC Scientific Document Group
PMID: 37622663
Lancet Respir Med. 2023 Oct;11(10):894-904. Prospective evaluation of the efficacy, safety, and optimal biomarker enrichment strategy for nangibotide, a TREM-1 inhibitor, in patients with septic shock (ASTONISH): a double-blind, randomised, controlled, phase 2b trial
Bruno François, Simon Lambden, Tom Fivez, Sebastien Gibot, Marc Derive, Jean-Marie Grouin, Margarita Salcedo-Magguilli, Jérémie Lemarié, Nicolas De Schryver, Ville Jalkanen, Tarik Hicheur, Jean-Jacques Garaud, Valérie Cuvier, Ricard Ferrer, Morten Bestle, Ville Pettilä, Jean-Paul Mira, Camille Bouisse, Emmanuelle Mercier, Joris Vermassen, Vincent Huberlant, Isabelle Vinatier, Nadia Anguel, Mitchell Levy, Pierre-François Laterre; ASTONISH investigators
PMID: 37269870 Abstract
Background: Activation of the triggering receptor expressed on myeloid cells-1 (TREM-1) pathway is associated with septic shock outcomes. Data suggest that modulation of this pathway in patients with activated TREM-1 might improve survival. Soluble TREM-1 (sTREM-1), a potential mechanism-based biomarker, might facilitate enrichment of patient selection in clinical trials of nangibotide, a TREM-1 modulator. In this phase 2b trial, we aimed to confirm the hypothesis that TREM1 inhibition might improve outcomes in patients with septic shock.
Methods: This double-blind, randomised, placebo-controlled, phase 2b trial assessed the efficacy and safety of two different doses of nangibotide compared with placebo, and aimed to identify the optimum treatment population, in patients across 42 hospitals with medical, surgical, or mixed intensive care units (ICUs) in seven countries. Non-COVID-19 patients (18-85 years) meeting the standard definition of septic shock, with documented or suspected infection (lung, abdominal, or urinary [in patients ≥65 years]), were eligible within 24 h of vasopressor initiation for the treatment of septic shock. Patients were randomly assigned in a 1:1:1 ratio to intravenous nangibotide 0·3 mg/kg per h (low-dose group), nangibotide 1·0 mg/kg per h (high-dose group), or matched placebo, using a computer-generated block randomisation scheme (block size 3). Patients and investigators were masked to treatment allocation. Patients were grouped according to sTREM-1 concentrations at baseline (established from sepsis observational studies and from phase 2a change to data) into high sTREM-1 (≥ 400 pg/mL). The primary outcome was the mean difference in total Sequential Organ Failure Assessment (SOFA) score from baseline to day 5 in the low-dose and high-dose groups compared with placebo, measured in the predefined high sTREM-1 (≥ 400 pg/mL) population and in the overall modified intention-to-treat population. Secondary endpoints included all-cause 28-day mortality, safety, pharmacokinetics, and evaluation of the relationship between TREM-1 activation and treatment response. This study is registered with EudraCT, 2018-004827-36, and Clinicaltrials.gov, NCT04055909.
Findings: Between Nov 14, 2019, and April 11, 2022, of 402 patients screened, 355 were included in the main analysis (116 in the placebo group, 118 in the low-dose group, and 121 in the high-dose group). In the preliminary high sTREM-1 population (total 253 [71%] of 355; placebo 75 [65%] of 116; low-dose 90 [76%] of 118; high-dose 88 [73%] of 121), the mean difference in SOFA score from baseline to day 5 was 0·21 (95% CI -1·45 to 1·87, p=0·80) in the low-dose group and 1·39 (-0·28 to 3·06, p=0·104) in the high-dose group versus placebo. In the overall population, the difference in SOFA score from baseline to day 5 between the placebo group and low-dose group was 0·20 (-1·09 to 1·50; p=0·76),and between the placebo group and the high-dose group was 1·06 (-0·23 to 2·35, p=0·108). In the predefined high sTREM-1 cutoff population, 23 (31%) patients in the placebo group, 35 (39%) in the low-dose group, and 25 (28%) in the high-dose group had died by day 28. In the overall population, 29 (25%) patients in the placebo, 38 (32%) in the low-dose, and 30 (25%) in the high-dose group had died by day 28. The number of treatment-emergent adverse events (111 [96%] patients in the placebo group, 113 [96%] in the low-dose group, and 115 [95%] in the high-dose group) and serious treatment-emergent adverse events (28 [24%], 26 [22%], and 31 [26%]) was similar between all three groups. High-dose nangibotide led to a clinically relevant improvement in SOFA score (of two points or more) from baseline to day 5 over placebo in those with higher cutoff concentrations (≥532 pg/mL) of sTREM-1 at baseline. Low dose nangibotide displayed a similar pattern with lower magnitude of effect across all cutoff values.
Interpretation: This trial did not achieve the primary outcome of improvement in SOFA score at the predefined sTREM-1 value. Future studies are needed to confirm the benefit of nangibotide at higher concentrations of TREM-1 activation.
J Cardiovasc Transl Res. 2023 Oct;16(5):1135-1143. Design and Rationale of the BIOFLOW-DAPT Trial: a Prospective, Randomized, Multicenter Study to Assess the Safety of the Orsiro Mission Stent Compared to the Resolute Onyx Stent in Subjects at High Risk for Bleeding in Combination with 1-Month Dual Antiplatelet Therapy
Antonio Landi, Adrian Wlodarczak, Ralph Tölg, Henning Kelbæk, Jacek Legutko, Stefano Galli, Matthieu Godin, Gabor G Toth, Thibault Lhermusier, Benjamin Honton, Peter Laurenz Dietrich, Francis Stammen, Bert Ferdinande, Johanne Silvain, Davide Capodanno, Guillaume Cayla, Marco Valgimigli; BIOFLOW-DAPT investigators
PMID: 37264295 Abstract
The optimal duration of dual antiplatelet therapy (DAPT) in high bleeding risk (HBR) patients undergoing percutaneous coronary intervention (PCI) with implantation of the Orsiro Mission stent remains unclear. The BIOFLOW-DAPT (clinicaltrials.gov, NCT04137510) trial is a prospective, multi-center, randomized controlled study designed to assess the safety of the Orsiro Mission versus the Resolute Onyx stent in HBR patients. Patients are treated with DAPT (aspirin and a P2Y12 inhibitor) for 1 month, followed by a single antiplatelet therapy (SAPT). The primary endpoint is the composite of cardiac death, myocardial infarction, and definite or probable stent thrombosis at 1 year. With a final sample size of 1948 HBR patients, this study is powered to assess the noninferiority of the Orsiro Mission stent with respect to the primary study endpoint. The BIOFLOW-DAPT is the first randomized clinical trial investigating 1-month DAPT duration in HBR patients after implantation of the Orsiro Mission stent.Trial Registration: ClinicalTrials.gov number, NCT04137510 Study design and key features. Patient selection starts before the index PCI, when consented patients will be randomized to the Orsiro Mission or the Resolute Onyx stent with mandated 1-month DAPT. At 1 month, eligibility is reassessed and if met, patients will discontinue DAPT and continue with P2Y12 inhibitor or aspirin monotherapy. PCI, percutaneous coronary intervention; DAPT, dual antiplatelet therapy; DES, drug-eluting stent; HBR, high bleeding risk; P2Y12i, P2Y12 inhibitor; ST, stent thrombosis.
Ann Surg. 2023 Oct 1;278(4):e885-e892. Current Outcome after Surgery for Type A Aortic Dissection
Fausto Biancari, Tatu Juvonen, Antonio Fiore, Andrea Perrotti, Amélie Hervé, Joseph Touma, Matteo Pettinari, Sven Peterss, Joscha Buech, Angelo M Dell'Aquila, Konrad Wisniewski, Andreas Rukosujew, Till Demal, Lenard Conradi, Marek Pol, Petr Kacer, Francesco Onorati, Cecilia Rossetti, Igor Vendramin, Daniela Piani, Mauro Rinaldi, Luisa Ferrante, Eduard Quintana, Robert Pruna-Guillen, Javier Rodriguez Lega, Angel G Pinto, Metesh Acharya, Zein El-Dean, Mark Field, Amer Harky, Francesco Nappi, Sebastien Gerelli, Dario Di Perna, Giuseppe Gatti, Enzo Mazzaro, Stefano Rosato, Peter Raivio, Mikko Jormalainen, Giovanni Mariscalco
PMID: 36912033 Abstract
Objective: The aim of this study was to evaluate the outcomes of different surgical strategies for acute Stanford type A aortic dissection (TAAD).
Summary background data: The optimal extent of aortic resection during surgery for acute TAAD is controversial.
Methods: This is a multicenter, retrospective cohort study of patients who underwent surgery for acute TAAD at 18 European hospitals.
Results: Out of 3902 consecutive patients, 689 (17.7%) died during the index hospitalization. Among 2855 patients who survived 3 months after surgery, 10-year observed survival was 65.3%, while country-adjusted, age-adjusted, and sex-adjusted expected survival was 81.3%, yielding a relative survival of 80.4%. Among 558 propensity score-matched pairs, total aortic arch replacement increased the risk of in-hospital (21.0% vs. 14.9%, P =0.008) and 10-year mortality (47.1% vs. 40.1%, P =0.001), without decreasing the incidence of distal aortic reoperation (10-year: 8.9% vs. 7.4%, P =0.690) compared with ascending aortic replacement. Among 933 propensity score-matched pairs, in-hospital mortality (18.5% vs. 18.0%, P =0.765), late mortality (at 10-year: 44.6% vs. 41.9%, P =0.824), and cumulative incidence of proximal aortic reoperation (at 10-year: 4.4% vs. 5.9%, P =0.190) after aortic root replacement was comparable to supracoronary aortic replacement.
Conclusions: Replacement of the aortic root and aortic arch did not decrease the risk of aortic reoperation in patients with TAAD and should be performed only in the presence of local aortic injury or aneurysm. The relative survival of TAAD patients is poor and suggests that the causes underlying aortic dissection may also impact late mortality despite surgical repair of the dissected aorta.
Eur J Surg Oncol. 2023 Oct;49(10):107001. Laparoscopic cytoreductive surgery and hyperthermic intraperitoneal chemotherapy: Long term oncologic outcomes from the international PSOGI registry
A Arjona-Sanchez, O Aziz, G Passot, G Salti, A Serrano, J Esquivel, K Van der Speeten, A Sommariva, M Kazi, U Shariff, F Martínez-Regueira, P Piso, Y Yonemura, K Turaga, O Sgarbura, A Avanish Saklani, M Tonello, L Rodriguez-Ortiz, M C Vazquez-Borrego, A Romero-Ruiz, O Glehen; International Laparoscopic PSOGI Registry
PMID: 37579618 Abstract
The laparoscopic approach for cytoreductive surgery and hyperthermic intraperitoneal chemotherapy (L-CRS + HIPEC) in highly selected patients was previously reported from the PSOGI registry with a demonstrable reduction in length of stay and post-operative morbidity. This study aims to update this international PSOGI registry with a larger cohort of patients and a longer follow-up period.
Methods: An international registry was designed through a networking database (REDCAP®). All centers performing L-CRS + HIPEC were invited through PSOGI to submit data on their cases. Variables such as demographics, clinical outcomes, and survival were analyzed.
Results: A total of 315 L-CRS + HIPEC cases were provided by 14 worldwide centers. A total of 215 patients were included in the L-CRS + HIPEC group. The median peritoneal cancer index (PCI) was 3 (3-5). The median length of stay was 7 days (5-10) and the major morbidity (Clavien-Dindo ≥3) was 6.1% after 30 days. The 5-year disease-free survival (DFS) per tumor origin was: 94% for PMP-LG, 85% for PMP-HG, 100% for benign multicyst peritoneal mesothelioma (MPM), 37.4% for colonic origin, and 54%(at 3 years) for ovarian origin. The 5 years overall survival (OS) per tumor origin was: 100% for PMP-LG, PMP-HG and MPM; 61% for colonic origin, and 74% (at 3 years) for ovarian origin. In addition, a total of 85 patients were analyzed in the laparoscopic risk-reducing HIPEC (L-RR + HIPEC). The median length of stay was 5 days (4-6) and the major morbidity was 6% after 30 days. The 5-year DFS per tumor origin was: 96% for perforated low grade appendiceal mucinous neoplasm (LAMN II) and 68.1% for colon origin. The 5 years OS per tumor origin was: 98% for LAMN II and 83.5% for colonic origin.
Conclusions: Minimally invasive CRS + HIPEC is a safe procedure for selected patients with peritoneal carcinomatosis in specialized centers. It improves perioperative results while providing satisfactory oncologic outcomes. L-RR + HIPEC represents a promising strategy that could be evaluated in patients with high risk of developing peritoneal carcinomatosis into prospective randomized trials.
Pilot Feasibility Stud. 2023 Oct 31;9(1):181. A randomized controlled trial comparing conservative versus surgical treatment in patients with foot drop due to peroneal nerve entrapment: results of an internal feasibility pilot study
Christophe Oosterbos, Sofie Rummens, Kris Bogaerts, Anaïs Van Hoylandt, Sophie Hoornaert, Frank Weyns, Annie Dubuisson, Jeroen Ceuppens, Sophie Schuind, Justus L Groen, Robin Lemmens, Tom Theys
PMID: 37908016 Abstract
Background: Based on the lack of literature to support any treatment strategy in patients with foot drop due to peroneal nerve entrapment, a prospective study randomizing patients between surgery and conservative treatment is warranted. Since studies comparing surgery to no surgery are often challenging, we first examined the feasibility of such a randomized controlled trial.
Methods/design: An internal feasibility pilot study was conducted to assess several aspects of process, resource, management, and scientific feasibility. The main objective was the assessment of the recruitment rate. The criterion to embark on a full study was the recruitment of at least 14 patients in 6 participating centers within 6 months. Cross-over rate, blinding measures, training strategies, and trial assessments were evaluated. The trial was entirely funded by the KCE Trials public funding program of the Belgian Health Care Knowledge Centre (ID KCE19-1232).
Results: The initial duration was prolonged due to the COVID-19 pandemic. Between April 2021 and October 2022, we included 19 patients of which 15 were randomized. Fourteen patients were treated as randomized. One drop-out occurred after randomization, prior to surgery. We did not document any cross-over or accidental unblinding. Training strategies were successful. Patients perceived the quality of life questionnaire as the least relevant assessment. Assessment of ankle dorsiflexion range of motion was prone to interobserver variability. All other trial assessments were adequate.
Neuromodulation. 2023 Oct;26(7):1433-1440. Long-Term Outcome in Patients With Spinal Cord Stimulation for Failed Back Surgery Syndrome: A 20-Year Audit of a Single Center
Martine Puylaert, Lynn Nijs, Klaas Buyse, Kris Vissers, Pascal Vanelderen, Margot Nagels, Thomas Daenekindt, Frank Weyns, Dieter Mesotten, Jan Van Zundert, Koen Van Boxem
PMID: 35577695 Abstract
Study design: This is a retrospective, observational study.
Introduction: Spinal cord stimulation (SCS) has found its application in chronic pain treatment, with failed back surgery syndrome (FBSS) as one of the most important indications. However, to date, little is known about the long-term effectiveness of the treatment. The aim of this study is to analyze retrospectively the long-term outcomes of SCS treatment in a single multidisciplinary pain center on predominant radicular pain, using devices of a single manufacturer.
Materials and methods: Patient data on overall patient satisfaction, pain intensity, and adverse events were retrospectively collected in our clinical practice between January 1998 and January 2018, for 191 patients who received a permanent SCS implant. Secondary health measures included the influence of opioid and nicotine use on pain reduction after therapy.
Results: The trial-to-implant ratio was 93.6%. At a mean follow-up of 10.6 years, 78.5% of the patients were satisfied with the treatment outcome, with a significant pain reduction of an average three points on a Numeric Rating Scale. Opioid and nicotine usage did not have a significant link with the pain reduction one year after the treatment. Furthermore, devices had an average battery lifespan of 8.4 years. A total of 248 revisions were recorded. A total of 24 patients (11.7%) acquired an infection; 7 of 204 patients had an infection during the trial period, 2 of 191 patients had an infection in the first postoperative year, and 15 of 191 patients had an infection after the first year. The average time to infection, if not in the first year, was 10.1 years.
Conclusions: A successful long-term outcome regarding pain relief in patients with predominant radicular pain due to FBSS is established with SCS therapy.
J Pers Med. 2023 Oct 18;13(10):1507. Influence of Moisturizers on Skin Microcirculation: An Assessment Study Using Laser Speckle Contrast Imaging
Ignace De Decker, Tanja Klotz, Peter Vu, Henk Hoeksema, Kimberly De Mey, Anse Beeckman, Bob Vermeulen, Marijn Speeckaert, Phillip Blondeel, Marcus Wagstaff, Stan Monstrey, Karel E Y Claes
PMID: 37888118 Abstract
Non-invasive scar management typically involves pressure therapy, hydration with silicones or moisturizers, and UV protection. Moisture loss from scars can lead to hypertrophic scar formation. Pressure therapy reduces blood flow, fibroblast activity, and transforming growth factor beta 1 (TGF-β1) release. This study examined various moisturizers and liquid silicone gel's impact on microcirculation. 40 volunteers participated in a study where superficial abrasions were created to induce trans epidermal water loss (TEWL). Five moisturizers (TEDRA®, TEDRA® NT1, TEDRA® NT3, Alhydran®, Lipikar®) and BAP Scar Care® silicone gel were tested. TEWL, hydration, and blood flow were measured up to 4 h post-application. Results showed that silicone had the least impact on occlusion and hydration. Alhydran® reduced blood flow the most, while Lipikar® increased it the most. TEDRA® NT1 had reduced flow compared to TEDRA® and TEDRA® NT3. All TEDRA® products exhibited high hydration, and all but silicone showed good occlusion. Moisturizers influenced skin microcirculation, with some causing decrease, while others increased flow. However, the clinical impact on scarring remains unclear compared to the evident effects of hydration and occlusion. More research is necessary to study moisturizers alone and with pressure therapy on scars, along with potential adverse effects of increased microcirculation on scars.
N Engl J Med. 2023 Oct 19;389(16):1477-1487. OCT or Angiography Guidance for PCI in Complex Bifurcation Lesions
Niels R Holm, Lene N Andreasen, Omeed Neghabat, Peep Laanmets, Indulis Kumsars, Johan Bennett, Niels T Olsen, Jacob Odenstedt, Pavel Hoffmann, Jo Dens, Saqib Chowdhary, Peter O'Kane, Søren-Haldur Bülow Rasmussen, Matthias Heigert, Ole Havndrup, Jan P Van Kuijk, Simone Biscaglia, Lone J H Mogensen, Loghman Henareh, Francesco Burzotta, Christian H Eek, Darren Mylotte, Miquel S Llinas, Lukasz Koltowski, Paul Knaapen, Slobodan Calic, Nils Witt, Irene Santos-Pardo, Stuart Watkins, Jacob Lønborg, Andreas T Kristensen, Lisette O Jensen, Fredrik Calais, James Cockburn, Andrew McNeice, Olli A Kajander, Ton Heestermans, Stephan Kische, Ashkan Eftekhari, James C Spratt, Evald H Christiansen; OCTOBER Trial Group
PMID: 37634149 Abstract
Background: Imaging-guided percutaneous coronary intervention (PCI) is associated with better clinical outcomes than angiography-guided PCI. Whether routine optical coherence tomography (OCT) guidance in PCI of lesions involving coronary-artery branch points (bifurcations) improves clinical outcomes as compared with angiographic guidance is uncertain.
Methods: We conducted a multicenter, randomized, open-label trial at 38 centers in Europe. Patients with a clinical indication for PCI and a complex bifurcation lesion identified by means of coronary angiography were randomly assigned in a 1:1 ratio to OCT-guided PCI or angiography-guided PCI. The primary end point was a composite of major adverse cardiac events (MACE), defined as death from a cardiac cause, target-lesion myocardial infarction, or ischemia-driven target-lesion revascularization at a median follow-up of 2 years.
Results: We assigned 1201 patients to OCT-guided PCI (600 patients) or angiography-guided PCI (601 patients). A total of 111 patients (18.5%) in the OCT-guided PCI group and 116 (19.3%) in the angiography-guided PCI group had a bifurcation lesion involving the left main coronary artery. At 2 years, a primary end-point event had occurred in 59 patients (10.1%) in the OCT-guided PCI group and in 83 patients (14.1%) in the angiography-guided PCI group (hazard ratio, 0.70; 95% confidence interval, 0.50 to 0.98; P = 0.035). Procedure-related complications occurred in 41 patients (6.8%) in the OCT-guided PCI group and 34 patients (5.7%) in the angiography-guided PCI group.
Conclusions: Among patients with complex coronary-artery bifurcation lesions, OCT-guided PCI was associated with a lower incidence of MACE at 2 years than angiography-guided PCI. (Funded by Abbott Vascular and others; OCTOBER ClinicalTrials.gov number, NCT03171311.).
EClinical Medicine. 2023 Oct 24:65:102304. First randomised controlled trial comparing the sirolimus-eluting bioadaptor with the zotarolimus-eluting drug-eluting stent in patients with de novo coronary artery lesions: 12-month clinical and imaging data from the multi-centre, international, BIODAPTOR-RCT
Shigeru Saito, Johan Bennett, Holger M Nef, Mark Webster, Atsuo Namiki, Akihiko Takahashi, Tsunekazu Kakuta, Seiji Yamazaki, Yoshisato Shibata, Douglas Scott, Mathias Vrolix, Madhav Menon, Helge Möllmann, Nikos Werner, Antoinette Neylon, Zlatko Mehmedbegovic, Pieter C Smits, Marie-Claude Morice, Stefan Verheye; BIOADAPTOR-RCT Collaborators
PMID: 38106564 Abstract
Background: The DynamX™ bioadaptor is the first coronary implant technology with a unique mechanism of unlocking the bioadaptor frame after polymer resorption over 6 months, uncaging the vessel while maintaining a dynamic support to the vessel. It aims to achieve the acute performance of drug-eluting stents (DES) with the advantages of restoration of vessel function.
Methods: This international, single blinded, randomised controlled (1:1) trial compared a sirolimus-eluting bioadaptor with a contemporary zotarolimus-eluting stent (DES) in 34 hospitals in Europe, Japan and New Zealand. Patients with de novo coronary lesions and absence of acute myocardial infarction were enrolled from January 2021 to Feburary 2022. The implantation of the bioadaptor followed the standards of DES. An imaging subset of 100 patients had angiographic and intravascular ultrasound assessments, and 20 patients additionally optical coherence tomography. Data collection will continue through 5 years, we herein report 12-month data based on an intention-to-treat population. This trial is registered at ClinicalTrials.gov (NCT04192747).
Findings: 445 patients were randomised between January 2021 and February 2022. Device, lesion and procedural success rates, and acute gain were similar amongst the groups. The primary endpoint, 12-month target lesion failure, was 1.8% [95% CI: 0.5; 4.6] (n = 4) versus 2.8% [95% CI: 1.0; 6.0] (n = 6), pnon-inferiority 0.001 for the bioadaptor and the DES, respectively (Δ-1.0% [95% CI: -3.3; 1.4]). One definite or probable device thrombosis occurred in each group. The 12-month imaging endpoints showed superior effectiveness of the bioadaptor such as in-device late lumen loss (0.09 mm [SD 0.34] versus 0.25 mm [SD 0.39], p = 0.04), and restored compliance and cyclic pulsatility (%mid in-device lumen area change of 7.5% versus 2.7%, p 0.001).
Interpretation: This is the first randomised controlled trial comparing the novel bioadaptor technology against a contemporary DES. The bioadaptor demonstrated similar acute performance and 12-month clinical outcomes, and superior imaging endpoints including restoration of vessel function.
Funding: The study was funded by Elixir Medical.
Ann Intensive Care. 2023 Nov 21;13(1):113. The effect of higher or lower mean arterial pressure on kidney function after cardiac arrest: a post hoc analysis of the COMACARE and NEUROPROTECT trials
Johanna Laurikkala, Koen Ameloot, Matti Reinikainen, Pieter-Jan Palmers, Cathy De Deyne, Ferdinande Bert, Matthias Dupont, Stefan Janssens, Joseph Dens, Johanna Hästbacka, Pekka Jakkula, Pekka Loisa, Thomas Birkelund, Erika Wilkman, Suvi T Vaara, Markus B Skrifvars
PMID: 37987871 Abstract
Background: We aimed to study the incidence of acute kidney injury (AKI) in out-of-hospital cardiac arrest (OHCA) patients treated according to low-normal or high-normal mean arterial pressure (MAP) targets.
Methods: A post hoc analysis of the COMACARE (NCT02698917) and Neuroprotect (NCT02541591) trials that randomized patients to lower or higher targets for the first 36 h of intensive care. Kidney function was defined using the Kidney Disease Improving Global Outcome (KDIGO) classification. We used Cox regression analysis to identify factors associated with AKI after OHCA.
Results: A total of 227 patients were included: 115 in the high-normal MAP group and 112 in the low-normal MAP group. Eighty-six (38%) patients developed AKI during the first five days; 40 in the high-normal MAP group and 46 in the low-normal MAP group (p = 0.51). The median creatinine and daily urine output were 85 μmol/l and 1730 mL/day in the high-normal MAP group and 87 μmol/l and 1560 mL/day in the low-normal MAP group. In a Cox regression model, independent AKI predictors were no bystander cardiopulmonary resuscitation (p 0.01), non-shockable rhythm (p 0.01), chronic hypertension (p = 0.03), and time to the return of spontaneous circulation (p 0.01), whereas MAP target was not an independent predictor (p = 0.29).
Conclusion: Any AKI occurred in four out of ten OHCA patients. We found no difference in the incidence of AKI between the patients treated with lower and those treated with higher MAP after CA. Higher age, non-shockable initial rhythm, and longer time to ROSC were associated with shorter time to AKI.
Eur J Heart Fail. 2023 Nov;25(11):1899-1922. State-of-the-art document on optimal contemporary management of cardiomyopathies
Petar M Seferović, Marija Polovina, Giuseppe Rosano, Biykem Bozkurt, Marco Metra, Stephane Heymans, Wilfried Mullens, Johann Bauersachs, Karen Sliwa, Rudolf A de Boer, Dimitrios Farmakis, Thomas Thum, Iacopo Olivotto, Claudio Rapezzi , Aleš Linhart, Domenico Corrado, Carsten Tschöpe, Ivan Milinković, Antoni Bayes Genis, Gerasimos Filippatos , Andre Keren , Milika Ašanin , Gordana Krljanac, Ružica Maksimović , Hadi Skouri , Tuvia Ben Gal , Brenda Moura , Maurizio Volterrani, Magdy Abdelhamid, Yuri Lopatin , Ovidiu Chioncel6, Andrew J S Coats
PMID: 37470300 Abstract
Cardiomyopathies represent significant contributors to cardiovascular morbidity and mortality. Over the past decades, a progress has occurred in characterization of the genetic background and major pathophysiological mechanisms, which has been incorporated into a more nuanced diagnostic approach and risk stratification. Furthermore, medications targeting core disease processes and/or their downstream adverse effects have been introduced for several cardiomyopathies. Combined with standard care and prevention of sudden cardiac death, these novel and emerging targeted therapies offer a possibility of improving the outcomes in several cardiomyopathies. Therefore, the aim of this document is to summarize practical approaches to the treatment of cardiomyopathies, which includes the evidence-based novel therapeutic concepts and established principles of care, tailored to the individual patient aetiology and clinical presentation of the cardiomyopathy. The scope of the document encompasses contemporary treatment of dilated, hypertrophic, restrictive and arrhythmogenic cardiomyopathy. It was based on an expert consensus reached at the Heart Failure Association online Workshop, held on 18 March 2021.
Catheter Cardiovasc Interv. 2023 Nov;102(5):864-877. Wire-based antegrade dissection re-entry technique for coronary chronic total occlusions percutaneous revascularization: Experience from the ERCTO Registry
Alfredo R Galassi, Giuseppe Vadalà, Laura Maniscalco, Gabriele Gasparini, Dens Jo, Nenad Z Bozinovic, Sevket Gorgulu, Thomas Gehrig, Luca Grancini, Imre Ungi, Eugenio La Scala, Andrew Ladwiniec, Sinisa Stojkovic, Alessio La Manna, Carlo Tumscitz, Simon Elhadad, Gerald S Werner, Georgios Sianos, Roberto Garbo, Mauro Carlino, Kambis Mashayekhi, Carlo di Mario
PMID: 37668012 Abstract
Background: The recent development and widespread adoption of antegrade dissection re-entry (ADR) techniques have been underlined as one of the antegrade strategies in all worldwide CTO consensus documents. However, historical wire-based ADR experience has suffered from disappointing long-term outcomes.
Aims: Compare technical success, procedural success, and long-term outcome of patients who underwent wire-based ADR technique versus antegrade wiring (AW).
Methods: One thousand seven hundred and ten patients, from the prospective European Registry of Chronic Total Occlusions (ERCTO), underwent 1806 CTO procedures between January 2018 and December 2021, at 13 high-volume ADR centers. Among all 1806 lesions attempted by the antegrade approach, 72% were approached with AW techniques and 28% with wire-based ADR techniques.
Results: Technical and procedural success rates were lower in wire-based ADR than in AW (90.3% vs. 96.4%, p 0.001; 87.7% vs. 95.4%, p 0.001, respectively); however, wire-based ADR was used successfully more often in complex lesions as compared to AW (p = 0.017). Wire-based ADR was used in most cases (85%) after failure of AW or retrograde procedures. At a mean clinical follow-up of 21 ± 15 months, major adverse cardiac and cerebrovascular events (MACCEs) did not differ between AW and wire-based ADR (12% vs. 15.1%, p = 0.106); both AW and wire-based ADR procedures were associated with significant symptom improvements.
Conclusions: As compared to AW, wire-based ADR is a reliable and effective strategy successfully used in more complex lesions and often after the failure of other techniques. At long-term follow-up, patient's MACCEs and symptoms improvement were similar in both antegrade techniques.
Eur J Hum Genet. 2023 Nov;31(11):1323-1332. Tools to differentiate between Filamin C and Titin truncating variant carriers: value of MRI
Johanna Jacobs, Lucas Van Aelst, Jeroen Breckpot, Anniek Corveleyn, Cuno Kuiperi, Matthias Dupont, Ward Heggermont, Katrien De Vadder, Rik Willems, Johan Van Cleemput, Jan G Bogaert, Tomas Robyns
PMID: 37032351 Abstract
Whereas truncating variants of the giant protein Titin (TTNtv) are the main cause of familial dilated cardiomyopathy (DCM), recently Filamin C truncating variants (FLNCtv) were identified as a cause of arrhythmogenic cardiomyopathy (ACM). Our aim was to characterize and compare clinical and MRI features of TTNtv and FLNCtv in the Belgian population. In index patients referred for genetic testing of ACM/DCM, FLNCtv and TTNtv were found in 17 (3.6%) and 33 (12.3%) subjects, respectively. Further family cascade screening yielded 24 and 19 additional truncating variant carriers in FLNC and TTN, respectively. The main phenotype was ACM in FLNCtv carriers whereas TTNtv carriers showed either an ACM or DCM phenotype. Non-sustained Ventricular Tachycardia was frequent in both populations. MRI data, available in 28/40 FLNCtv and 32/52 TTNtv patients, showed lower Left Ventricular (LV) ejection fraction and lower LV strain in TTNtv patients (p 0.01). Conversely, both the frequency (68% vs 22%) and extent of non-ischemic myocardial late gadolinium enhancement (LGE) was significantly higher in FLNCtv patients (p 0.01). Hereby, ring-like LGE was found in 16/19 (84%) FLNCtv versus 1/7 (14%) of TTNtv patients (p 0.01). In conclusion, a large number of FLNCtv and TTNtv patients present with an ACM phenotype but can be separated by cardiac MRI. Whereas FLNCtv patients often have extensive myocardial fibrosis, typically following a ring-like pattern, LV dysfunction without or limited replacement fibrosis is the common TTNtv phenotype.
BMC Med Res Methodol. 2023 Nov 24;23(1):276. Multiclass risk models for ovarian malignancy: an illustration of prediction uncertainty due to the choice of algorithm
Ashleigh Ledger, Jolien Ceusters, Lil Valentin, Antonia Testa, Caroline Van Holsbeke, Dorella Franchi, Tom Bourne, Wouter Froyman, Dirk Timmerman, Ben Van Calster
PMID: 38001421 Abstract
Background: Assessing malignancy risk is important to choose appropriate management of ovarian tumors. We compared six algorithms to estimate the probabilities that an ovarian tumor is benign, borderline malignant, stage I primary invasive, stage II-IV primary invasive, or secondary metastatic.
Methods: This retrospective cohort study used 5909 patients recruited from 1999 to 2012 for model development, and 3199 patients recruited from 2012 to 2015 for model validation. Patients were recruited at oncology referral or general centers and underwent an ultrasound examination and surgery ≤ 120 days later. We developed models using standard multinomial logistic regression (MLR), Ridge MLR, random forest (RF), XGBoost, neural networks (NN), and support vector machines (SVM). We used nine clinical and ultrasound predictors but developed models with or without CA125.
Results: Most tumors were benign (3980 in development and 1688 in validation data), secondary metastatic tumors were least common (246 and 172). The c-statistic (AUROC) to discriminate benign from any type of malignant tumor ranged from 0.89 to 0.92 for models with CA125, from 0.89 to 0.91 for models without. The multiclass c-statistic ranged from 0.41 (SVM) to 0.55 (XGBoost) for models with CA125, and from 0.42 (SVM) to 0.51 (standard MLR) for models without. Multiclass calibration was best for RF and XGBoost. Estimated probabilities for a benign tumor in the same patient often differed by more than 0.2 (20% points) depending on the model. Net Benefit for diagnosing malignancy was similar for algorithms at the commonly used 10% risk threshold, but was slightly higher for RF at higher thresholds. Comparing models, between 3% (XGBoost vs. NN, with CA125) and 30% (NN vs. SVM, without CA125) of patients fell on opposite sides of the 10% threshold.
Conclusion: Although several models had similarly good performance, individual probability estimates varied substantially.
Int J Cardiol. 2023 Nov 15:391:131274. Clinical outcomes of coronary intravascular lithotripsy in patients with stent failure (COIL registry)
Michał Kuzemczak, Janusz Lipiecki, Visvesh Jeyalan, Hicham Farhat, Paweł Kleczyński, Jacek Legutko, Lennert Minten, Johan Bennett, Ella Poels, Joseph Dens, Ioakim Spyridopoulos, Vijay Kunadian, Tomasz Pawłowski, Robert Gil, Mohaned Egred, Azfar Zaman, Mohammad Alkhalil
PMID: 37598907 Abstract
Background: Intravascular lithotripsy (IVL) has been demonstrated to be an effective treatment of calcified de novo coronary lesions. Safety data on the use of IVL within stented segments are lacking. We sought to evaluate the safety, feasibility, and long-term outcomes of IVL in patients with stent failure.
Methods: This was a retrospective multi-centre registry that included consecutive patients with stent failure who had undergone IVL treatment. The primary efficacy endpoint was procedural success defined as residual stenosis 30% (determined by quantitative coronary angiography analysis) in patients who survived hospital admission without in-hospital adverse events. Major adverse cardiovascular events (MACE) were defined as the composite endpoints of cardiovascular death, spontaneous myocardial infarction, and target vessel revascularisation at one-year follow up.
Results: 102 patients were included in this study. Mean age was 73 ± 9 years and 81% were male. The duration from previous stent implantation and IVL treatment was 24 (interquartile range 7-76) months, of which 10.8% received IVL for acute under-expanded stent. IVL treatment allowed significant improvement in both minimal lumen diameter (1.14 ± 0.60 to 2.53 ± 0.59, P 0.001) and degree of stenosis (66.8 ± 19.9 to 20.3 ± 11.3%, P 0.001). The rate of procedural success was 78.4% (80/102 of patients). The one-year MACE was 15.7%. Ostial disease (HR 5.16; 95% CI 1.19 to 22.33; P = 0.028) and lesion length (HR 1.05; 95% CI 1.01 to 1.10; P = 0.010) were independently associated with one-year MACE.
Conclusions: In patients with stent failure, IVL is a safe and feasible treatment for this high-risk group
Circ Arrhythm Electrophysiol. 2023 Nov;16(11):e012043. No Effect of Continued Antiarrhythmic Drug Treatment on Top of Optimized Pulmonary Vein Isolation in Patients With Persistent Atrial Fibrillation: Results From the POWDER-AF2 Trial
Anthony Demolder, Louisa O'Neill, Milad El Haddad, Daniel Scherr, Johan Vijgen, Michael Wolf, Benjamin Berte, Felipe Bisbal, Arne Johannessen, Maximo Rivero-Ayerza, Tom De Potter, Benjamin De Becker, Jean-Benoît le Polain de Waroux, Sebastien Knecht, Rene Tavernier, Mattias Duytschaever
PMID: 37921006 Abstract
Background: In patients with persistent atrial fibrillation (PersAF), catheter ablation aiming for pulmonary vein isolation (PVI) is associated with moderate clinical effectiveness. We investigated the benefit of continuing previously ineffective class 1C or 3 antiarrhythmic drug therapy (ADT) in the setting of a standardized PVI-only ablation strategy.
Methods: In this multicenter, randomized controlled study, patients with PersAF (≥7 days and 12 months) despite ADT were prospectively randomized 1:1 to PVI with ADT continued versus discontinued beyond the blanking period (ADT ON versus ADT OFF). Standardized catheter ablation was performed aiming for durable isolation with stable, contiguous, and optimized radio frequency applications encircling the pulmonary veins (CLOSE protocol). Clinical visits and 1-to-7-day Holter were performed at 3, 6, and 12 months. The primary end point was any documented atrial tachyarrhythmia lasting >30 seconds beyond 3 months. Prospectively defined secondary end points included repeat ablations, unscheduled arrhythmia-related visits, and quality of life among groups.
Results: Of 200 PersAF patients, 98 were assigned to ADT OFF and 102 to ADT ON. The longest atrial fibrillation episode qualifying for PersAF was 28 (10-90) versus 30 (11-90) days. Clinical characteristics and procedural characteristics were similar. Recurrence of atrial tachyarrhythmia was comparable in both groups (20% OFF versus 21.2% ON). No differences were observed in repeat ablations and unscheduled arrhythmia-related visits. Marked improvement in quality of life was observed in both groups.
Conclusions: In patients with PersAF, there is no benefit in continuing previously ineffective ADT beyond the blanking period after catheter ablation. The high success rate of PVI-only might be explained by the high rate of durable isolation after optimized PVI and the early stage of PersAF (POWDER-AF2).
J Card Fail. 2023 Nov;29(11):1522-1530. Fewer Worsening Heart Failure Events With HeartLogic on top of Standard Care: a Propensity-Matched Cohort Analysis
Michelle Feijen, Monika Beles, Yan Zhi Tan, Audrey Cordon, Matthias Dupont, Roderick W Treskes, Maria-Luce Caputo, Koen VAN Bockstal, Angelo Auricchio, Anastasia D Egorova, Edith Maes, Saskia L M A Beeres, Ward A Heggermont
PMID: 37220824 Abstract
Background: The implantable cardiac defibrillator-based HeartLogic algorithm aims to detect impending fluid retention in patients with heart failure (HF). Studies show that HeartLogic is safe to integrate into clinical practice. The current study investigates whether HeartLogic provides clinical benefit on top of standard care and device telemonitoring in patients with HF.
Methods: A multicenter, retrospective, propensity-matched cohort analysis was performed in patients with HF and implantable cardiac defibrillators, and it compared HeartLogic to conventional telemonitoring. The primary endpoint was the number of worsening HF events. Hospitalizations and ambulatory visits due to HF were also evaluated.
Results: Propensity score matching yielded 127 pairs (median age 68 years, 80% male). Worsening HF events occurred more frequently in the control group (2; IQR 0-4) compared to the HeartLogic group (1; IQR 0-3; P = 0.004). The number of HF hospitalization days was higher in controls than in the HeartLogic group (8; IQR 5-12 vs 5; IQR 2-7; P = 0.023), and ambulatory visits for diuretic escalation were more frequent in the control group than in the HeartLogic group (2; IQR 0-3 vs 1; IQR 0-2; P = 0.0001).
Conclusion: Integrating the HeartLogic algorithm in a well-equipped HF care path on top of standard care is associated with fewer worsening HF events and shorter duration of fluid retention-related hospitalizations.
Children (Basel). 2023 Nov 28;10(12):1866. Testing a Home Solution for Preparing Young Children for an Awake MRI: A Promising Smartphone Application
Sam Geuens, Jurgen Lemiere, Jessica Nijs, Marlies Treunen, Michael Aertsen, Jaan Toelen, Greet Pauwels, Kate Sauer, Marlies Potoms, Sofie Van Cauter, Leen Wouters, Kathrin Hohlbaum, Marie Sjölinder, Olov Ståhl, Gunnar Buyse, Philippe Demaerel, Barbara Weyn
PMID: 38136068 Abstract
Thanks to its non-invasive nature and high-resolution imaging capabilities, magnetic resonance imaging (MRI) is a valuable diagnostic tool for pediatric patients. However, the fear and anxiety experienced by young children during MRI scans often result in suboptimal image quality and the need for sedation/anesthesia. This study aimed to evaluate the effect of a smartphone application called COSMO@home to prepare children for MRI scans to reduce the need for sedation or general anesthesia. The COSMO@home app was developed incorporating mini-games and an engaging storyline to prepare children for learning goals related to the MRI procedure. A multicenter study was conducted involving four hospitals in Belgium. Eligible children aged 4-10 years were prepared with the COSMO@home app at home. Baseline, pre-scan, and post-scan questionnaires measured anxiety evolution in two age groups (4-6 years and 7-10 years). Eighty-two children participated in the study, with 95% obtaining high-quality MRI images. The app was well-received by children and parents, with minimal technical difficulties reported. In the 4-6-year-old group (N = 33), there was a significant difference between baseline and pre-scan parent-reported anxiety scores, indicating an increase in anxiety levels prior to the scan. In the 7-10-year-old group (N = 49), no significant differences were observed between baseline and pre-scan parent-reported anxiety scores. Overall, the COSMO@home app proved to be useful in preparing children for MRI scans, with high satisfaction rates and successful image outcomes across different hospitals. The app, combined with minimal face-to-face guidance on the day of the scan, showed the potential to replace or assist traditional face-to-face training methods. This innovative approach has the potential to reduce the need for sedation or general anesthesia during pediatric MRI scans and its associated risks and improve patient experience.
Sci Rep. 2023 Nov 7;13(1):19322. Comprehensive antibody and cytokine profiling in hospitalized COVID-19 patients in relation to clinical outcomes in a large Belgian cohort
Pieter Ruytinx, Patrick Vandormael, Judith Fraussen, Zoë Pieters, Stef Thonissen, Niels Hellings, Piet Stinissen, Ina Callebaut, Joris Penders, Karolien Vanhove, Davy Kieffer, Jean-Luc Rummens, Tom Valkenborgh, Peter Messiaen, Björn Stessel, Dieter Mesotten, Veerle Somers
PMID: 37935729 Abstract
The immune response in patients with Coronavirus Disease 2019 (COVID-19) is highly variable and is linked to disease severity and mortality. However, antibody and cytokine responses in the early disease stage and their association with disease course and outcome are still not completely understood. In this large, multi-centre cohort study, blood samples of 434 Belgian COVID-19 hospitalized patients with different disease severities (ranging from asymptomatic/mild to critically ill) from the first wave of the COVID-19 pandemic were obtained. Baseline antibody and cytokine responses were characterized and associations with several clinical outcome parameters were determined. Anti-spike immunoglobulin (Ig)G and IgM levels were elevated in patients with a more severe disease course. This increased baseline antibody response however was associated with decreased odds for hospital mortality. Levels of the pro-inflammatory cytokines IL-6, IP-10 and IL-8, the anti-inflammatory cytokine IL-10 and the antiviral cytokines IFN-α, IFN-β and IFN-λ1 were increased with disease severity. Remarkably, we found significantly lower levels of IFN-λ2,3 in critically ill patients compared to patients of the moderate and severe disease category. Finally, levels of IL-8, IL-6, IP-10, IL-10, IFN-α, IFN-β, IFN-γ and IFN-λ1 at baseline were positively associated with mortality, whereas higher IFN-λ2,3 levels were negatively associated with mortality
N Engl J Med. 2023 Sep 14;389(11):1041-1042. Treating Iron Deficiency in Heart Failure Pieter Martens, Wilfried Mullens
PMID: 37632465
No abstract available
Clin Kidney J. 2023 Sep 1;16(11):1709-1713. Proton pump inhibitors and adverse kidney outcomes during immune checkpoint blockade: time to sound the alarm?
Hui Zhuan Tan, Ben Sprangers
PMID: 37915924 Abstract
Immune checkpoint inhibitors (ICIs) have significantly altered the treatment landscape for cancer in the last decade. However, their benefits are often offset by therapy-limiting immune-related adverse events (irAEs). Acute interstitial nephritis (AIN) is the most common renal irAE, but the exact mechanisms underlying its development are poorly understood. ICI-induced immune activation against drug-derived antigens, leading to an inflammatory response within the kidney interstitium, has been postulated, evidenced by current observations of a higher incidence of ICI-associated AIN in patients receiving AIN-inducing drugs such as proton pump inhibitors (PPIs). The role of PPIs in this specific context has garnered significant attention, given their ubiquitous use and sometimes misuse. In this issue of CKJ Miao et al. summarise and synthesize the best available evidence to clarify the interactions of PPIs with ICIs in the development of AIN and other adverse kidney outcomes. The sum of evidence provided appear to implicate PPIs in the development of clinically significant short- and long-term kidney-related adverse effects in patients on immune checkpoint blockade, although causality cannot be proven. In this editorial we discuss the key practical implications of these findings and emphasize the need for further quality studies to delineate the true relationship of ICIs and PPIs in the development of AIN.
World J Surg. 2023 Sep;47(9):2241-2249. Robotic Versus Laparoscopic Hepatectomy: A Single Surgeon Experience of 629 Consecutive Minimally Invasive Liver Resections
Thomas Winckelmans, Dennis A Wicherts, Isabelle Parmentier, Celine De Meyere, Chris Verslype, Mathieu D'Hondt
PMID: 37208537 Abstract
Background: Robotic surgery has the potential to broaden the indications for minimally invasive liver surgery owing to its technical advantages. This paper compares our experience with robotic liver surgery (RLS) with conventional laparoscopic liver surgery (LLS).
Methods: All consecutive liver resections between October 2011 and October 2022 were selected from our prospective database to be included in this cohort study. Patients who underwent RLS were compared with a LLS group for operative and postoperative outcomes.
Results: In total, 629 patients were selected from our database, including 177 patients who underwent a RLS and 452 patients who had LLS. Colorectal liver metastasis was the main indication for surgery in both groups. With the introduction of RLS, the percentage of open resections decreased significantly (32.6% from 2011 to 2020 vs. 11.5% from 2020 onward, P 0.001). In the robotic group, redo liver surgery was more frequent (24.3% vs. 16.8%, P = 0.031) and the Southampton difficulty score was higher (4 [IQR 4 to 7] vs. 4 [IQR 3 to 6], P = 0.02). Median blood loss was lower (30 vs. 100 ml, P 0.001), and postoperative length of stay (LOS) was shorter in the robotic group (median 3 vs. 4 days, P 0.001). There was no significant difference in postoperative complications. Cost related to the used instruments and LOS was significantly lower in the RLS group (median €1483 vs. €1796, P 0.001 and €1218 vs. €1624, P 0.001, respectively), while cost related to operative time was higher (median €2755 vs. €2470, P 0.001).
Conclusions: RLS may allow for a higher percentage of liver resections to be completed in a minimally invasive way with lower blood loss and a shorter LOS.
Nat Med. 2023 Sep;29(9):2206-2215. Cell-free DNA methylome analysis for early preeclampsia prediction
Marie De Borre, Huiwen Che, Qian Yu, Lore Lannoo, Kobe De Ridder, Leen Vancoillie, Pauline Dreesen, Mika Van Den Ackerveken, Mio Aerden, Eva Galle, Jeroen Breckpot, Joachim Van Keirsbilck, Wilfried Gyselaers, Koen Devriendt, Joris Robert Vermeesch, Kristel Van Calsteren, Bernard Thienpont
PMID: 37640858 Abstract
Preeclampsia (PE) is a leading cause for peripartal morbidity, especially if developing early in gestation. To enable prophylaxis in the prevention of PE, pregnancies at risk of PE must be identified early-in the first trimester. To identify at-risk pregnancies we profiled methylomes of plasma-derived, cell-free DNA from 498 pregnant women, of whom about one-third developed early-onset PE. We detected DNA methylation differences between control and PE pregnancies that enabled risk stratification at PE diagnosis but also presymptomatically, at around 12 weeks of gestation (range 9-14 weeks). The first-trimester risk prediction model was validated in an external cohort collected from two centers (area under the curve (AUC) = 0.75) and integrated with routinely available maternal risk factors (AUC = 0.85). The combined risk score correctly predicted 72% of patients with early-onset PE at 80% specificity. These preliminary results suggest that cell-free DNA methylation profiling is a promising tool for presymptomatic PE risk assessment, and has the potential to improve treatment and follow-up in the obstetric clinic.
Acta Gastroenterol Belg. 2023 Jul-Sep;86(3):483-485. Biliary papillomatosis
F Gelders, M Struyve, H van Malenstein
PMID: 37814564 Abstract
Biliary papillomatosis (BP) is a rare disorder of the biliary tract characterized by the presence of multiple papillary adenomas spread along the biliary tree. Although benign, it carries a significant risk of malignant transformation. Due to low sensitivity and specificity of conventional radiologic modalities, the diagnosis as well as estimation of disease extent is difficult. Endoscopic ultrasound (EUS) and endoscopic retrograde cholangiopancreaticography (ERCP) are superior although direct peroral cholangioscopy (POC) is currently the most accurate diagnostic method. Mainly because it provides more detailed information and makes targeted histological diagnosis possible. The treatment of biliary papillomatosis consists of surgical resection, liver transplantation (LT) or a combination of both. Unfortunately, the recurrence rate after radical surgery without LT remains high due to the diffuse distribution of the disease.
Eur J Cardiothorac Surg. 2023 Sep 7;64(3):ezad282. Reply to Waller et al
Alessandro Brunelli, Herbert Decaluwe, Michel Gonzalez, Dominique Gossot, Rene Horsleben Petersen
PMID: 37632779
No abstract available
J Med Internet Res. 2023 Sep 6:25:e42686. Changes in Intrapersonal Factors of Participants in the Pregnancy Remote Monitoring Study Who Are at Risk for Pregnancy-Induced Hypertension: Descriptive Quantitative Study Dorien Lanssens, Thijs Vandenberk, Valerie Storms, Inge Thijs, Lars Grieten, Lotte Bamelis, Wilfried Gyselaers, Eileen Tang, Patrick Luyten
PMID: 37672324 Abstract
Background: The peripartum period, defined as the period from the beginning of the gestation until 1 year after the delivery, has long been shown to be potentially associated with increased levels of stress and anxiety with regard to one's transition to the status of parent and the accompanying parental tasks. Yet, no research to date has investigated changes in intrapersonal factors during the peripartum period in women at risk for pregnancy-induced hypertension (PIH).
Objective: The aim of this study is to explore and describe changes in intrapersonal factors in participants at risk for PIH.
Methods: We used an explorative design in which 3 questionnaires were sent by email to 110 participants the day following enrollment in the Pregnancy Remote Monitoring program for pregnant women at risk for PIH. Women were invited to complete the questionnaires at the beginning of their participation in the Pregnancy Remote Monitoring project (mostly at 14 weeks of gestation) and after approaching 32 weeks of gestational age (GA). The Generalized Anxiety Disorder-7 Scale (GAD-7) and the Patient Health Questionnaire-9 were used to assess anxiety and depression, and adaptation of the Pain Catastrophizing Scale was used to measure trait pain catastrophizing.
Results: Scores were significantly higher at 32 weeks of GA than at the moment of enrollment (GAD-7 score=7, range 4-11 vs 5, range 3-8; P=.01; and Patient Health Questionnaire-9 score=6, range 4-10 vs 4, range 2-7; P.001). The subscale scores of the Pain Catastrophizing Scale were all lower at 32 weeks of GA compared with 14 weeks of GA (rumination: 4, range 1-6 vs 5, range 2-9.5; P=.11; magnification: 3, range 1-5.5 vs 4, range 3-7; P=.04; and helplessness: 5, range 2-9 vs 6, range 3.5-12; P=.06). The proportion of women with a risk for depression (GAD-7 score >10) was 13.3% (10/75) at enrollment and had increased to 35.6% (26/75) at 32 weeks of GA.
Conclusions: This study shows that pregnant women at risk for PIH have higher levels of stress and anxiety at 32 weeks of GA than at the moment of enrollment. Further research is recommended to investigate potential strategies to help pregnant women at risk for PIH manage feelings of stress and anxiety.
Acta Orthop Belg.2023 Sep;89(3):417-422. Outcome of lateral retinacular nerve transection combined with release for recalcitrant iliotibial band friction syndrome
J Kloos, J Bellemans
PMID: 37935223 Abstract
In this retrospective study, a technique consisting in neurolysis of the lateral retinacular nerve combined with a partial release through elliptic excision of the iliotibial band (ITB) is evaluated for efficacy in recalcitrant ITB friction syndrome and compared with results from other techniques reported in literature. From April 2014 to December 2017, 21 patients suffering from recalcitrant ITB friction syndrome were surgically treated with the aforementioned technique. 15 patients (15 knees) were available for a written retrospective reassessment after completion of a follow-up period of at least 12 months. Residual pain was scored using the Visual Analogue Scale (VAS). The functional outcome was evaluated by two patient reported outcome measurement scales (PROMs), the Lysholm and the International Knee Documentation Committee (IKDC) score. Return to sport was analysed by duration of the inactivity period as well as by the Tegner score. Overall satisfaction was evaluated using a modified Boyden scale. At final follow-up of one year, the performed intervention resulted in a pain reduction (VAS 4.2 (1-8) to 1.4 (0-6)) and improved knee function (Lysholm 59.53 to 87.73, IKDC 75) with return to sport (Tegner 4.3 to 5.4) after a median of 23.8 weeks (6 to 52). Twelve patients reported good or excellent results (80%) at final follow-up, and 12 patients (80%) would undergo surgery again, if necessary. The treatment of recalcitrant ITB friction syndrome by combining neurectomy of the lateral retinacular nerve with elliptic excision of the ITB resulted in good to excellent results in 80% of treated cases with return to sport in 93%.
Lancet. 2023 Sep 30;402(10408):1147-1157. Adaptive versus conventional cardiac resynchronisation therapy in patients with heart failure (AdaptResponse): a global, prospective, randomised controlled trial
Bruce L Wilkoff, Gerasimos Filippatos, Christophe Leclercq, Michael R Gold, Ahmad S Hersi, Kengo Kusano, Wilfried Mullens, G Michael Felker, Charan Kantipudi, Mikhael F El-Chami, Vidal Essebag, Bertrand Pierre, Francois Philippon, Francisco Perez-Gil, Eugene S Chung, Juan Sotomonte, Stanley Tung, Balbir Singh, Babak Bozorgnia, Satish Goel, Hans Holger Ebert, Niraj Varma, Kara J Quan, Fiorella Salerno, Bart Gerritse, Janelle van Wel, Daniel E Schaber, Dedra H Fagan, David Birnie; AdaptResponse investigators
PMID: 37634520
Eur Heart J Digit Health. 2023 Sep 30;4(6):464-472. Smartphone-based atrial fibrillation screening in the general population: feasibility and impact on medical treatment
Henri Gruwez, Frederik H Verbrugge, Tine Proesmans, Stijn Evens, Peter Vanacker, Matthieu Pierre Rutgers, Geert Vanhooren, Philippe Bertrand, Laurent Pison, Peter Haemers, Pieter Vandervoort, Dieter Nuyens
PMID: 38045439 Abstract
Aims: The aim of this study is to determine the feasibility, detection rate, and therapeutic implications of large-scale smartphone-based screening for atrial fibrillation (AF).
Methods and results: Subjects from the general population in Belgium were recruited through a media campaign to perform AF screening during 8 consecutive days with a smartphone application. The application analyses photoplethysmography traces with artificial intelligence and offline validation of suspected signals to detect AF. The impact of AF screening on medical therapy was measured through questionnaires. Atrial fibrillation was detected in the screened population (n = 60.629) in 791 subjects (1.3%). From this group, 55% responded to the questionnaire. Clinical AF [AF confirmed on a surface electrocardiogram (ECG)] was newly diagnosed in 60 individuals and triggered the initiation of anti-thrombotic therapy in 45%, adjustment of rate or rhythm controlling strategies in 62%, and risk factor management in 17%. In subjects diagnosed with known AF before screening, a positive screening result led to these therapy adjustments in 9%, 39%, and 11%, respectively. In all subjects with clinical AF and an indication for oral anti-coagulation (OAC), OAC uptake increased from 56% to 74% with AF screening. Subjects with clinical AF were older with more co-morbidities compared with subclinical AF (no surface ECG confirmation of AF) (P 0.001). In subjects with subclinical AF (n = 202), therapy adjustments were performed in only 7%.
Conclusion: Smartphone-based AF screening is feasible at large scale. Screening increased OAC uptake and impacted therapy of both new and previously diagnosed clinical AF but failed to impact risk factor management in subjects with subclinical AF.
Heliyon. 2023 Oct 5;9(10):e20702. Preoperative arterial lactate and outcome after surgery for type A aortic dissection: The ERTAAD multicenter study
Fausto Biancari, Francesco Nappi, Giuseppe Gatti, Andrea Perrotti, Amélie Hervé, Stefano Rosato, Paola D'Errigo, Matteo Pettinari, Sven Peterss, Joscha Buech, Tatu Juvonen, Mikko Jormalainen, Caius Mustonen, Till Demal, Lenard Conradi, Marek Pol, Petr Kacer, Angelo M Dell'Aquila, Konrad Wisniewski, Igor Vendramin, Daniela Piani, Luisa Ferrante, Timo Mäkikallio, Eduard Quintana, Robert Pruna-Guillen, Antonio Fiore, Thierry Folliguet, Giovanni Mariscalco, Metesh Acharya, Mark Field, Manoj Kuduvalli, Francesco Onorati, Cecilia Rossetti, Sebastien Gerelli, Dario Di Perna, Enzo Mazzaro, Angel G Pinto, Javier Rodriguez Lega, Mauro Rinaldi Abstract
Background: Acute type A aortic dissection (TAAD) is associated with significant mortality and morbidity. In this study we evaluated the prognostic significance of preoperative arterial lactate concentration on the outcome after surgery for TAAD.
Methods: The ERTAAD registry included consecutive patients who underwent surgery for acute type A aortic dissection (TAAD) at 18 European centers of cardiac surgery.
Results: Data on arterial lactate concentration immediately before surgery were available in 2798 (71.7 %) patients. Preoperative concentration of arterial lactate was an independent predictor of in-hospital mortality (mean, 3.5 ± 3.2 vs 2.1 ± 1.8 mmol/L, adjusted OR 1.181, 95%CI 1.129-1.235). The best cutoff value preoperative arterial lactate concentration was 1.8 mmol/L (in-hospital mortality, 12.0 %, vs. 26.6 %, p 0.0001). The rates of in-hospital mortality increased along increasing quintiles of arterial lactate and it was 12.1 % in the lowest quintile and 33.6 % in the highest quintile (p 0.0001). The difference between multivariable models with and without preoperative arterial lactate was statistically significant (p = 0.0002). The NRI was 0.296 (95%CI 0.200-0.391) (p 0.0001) with -17 % of events correctly reclassified (p = 0.0002) and 46 % of non-events correctly reclassified (p 0.0001). The IDI was 0.025 (95%CI 0.016-0.034) (p 0.0001). Six studies from a systematic review plus the present one provided data for a pooled analysis which showed that the mean difference of preoperative arterial lactate between 30-day/in-hospital deaths and survivors was 1.85 mmol/L (95%CI 1.22-2.47, p 0.0001, I2 64 %).
Conclusions: Hyperlactatemia significantly increased the risk of mortality after surgery for acute TAAD and should be considered in the clinical assessment of these critically ill patients.
Eur Heart J. 2023 Oct 14;44(39):4043-4140. 2023 ESC Guidelines for the management of cardiovascular disease in patients with diabetes
Nikolaus Marx, Massimo Federici, Katharina Schütt, Dirk Müller-Wieland, Ramzi A Ajjan, Manuel J Antunes, Ruxandra M Christodorescu, Carolyn Crawford, Emanuele Di Angelantonio, Björn Eliasson, Christine Espinola-Klein, Laurent Fauchier, Martin Halle, William G Herrington, Alexandra Kautzky-Willer, Ekaterini Lambrinou, Maciej Lesiak, Maddalena Lettino, Darren K McGuire, Wilfried Mullens, Bianca Rocca, Naveed Sattar; ESC Scientific Document Group
PMID: 37622663
Lancet Respir Med. 2023 Oct;11(10):894-904. Prospective evaluation of the efficacy, safety, and optimal biomarker enrichment strategy for nangibotide, a TREM-1 inhibitor, in patients with septic shock (ASTONISH): a double-blind, randomised, controlled, phase 2b trial
Bruno François, Simon Lambden, Tom Fivez, Sebastien Gibot, Marc Derive, Jean-Marie Grouin, Margarita Salcedo-Magguilli, Jérémie Lemarié, Nicolas De Schryver, Ville Jalkanen, Tarik Hicheur, Jean-Jacques Garaud, Valérie Cuvier, Ricard Ferrer, Morten Bestle, Ville Pettilä, Jean-Paul Mira, Camille Bouisse, Emmanuelle Mercier, Joris Vermassen, Vincent Huberlant, Isabelle Vinatier, Nadia Anguel, Mitchell Levy, Pierre-François Laterre; ASTONISH investigators
Collaborators, Affiliations expand
PMID: 37269870 Abstract
Background: Activation of the triggering receptor expressed on myeloid cells-1 (TREM-1) pathway is associated with septic shock outcomes. Data suggest that modulation of this pathway in patients with activated TREM-1 might improve survival. Soluble TREM-1 (sTREM-1), a potential mechanism-based biomarker, might facilitate enrichment of patient selection in clinical trials of nangibotide, a TREM-1 modulator. In this phase 2b trial, we aimed to confirm the hypothesis that TREM1 inhibition might improve outcomes in patients with septic shock.
Methods: This double-blind, randomised, placebo-controlled, phase 2b trial assessed the efficacy and safety of two different doses of nangibotide compared with placebo, and aimed to identify the optimum treatment population, in patients across 42 hospitals with medical, surgical, or mixed intensive care units (ICUs) in seven countries. Non-COVID-19 patients (18-85 years) meeting the standard definition of septic shock, with documented or suspected infection (lung, abdominal, or urinary [in patients ≥65 years]), were eligible within 24 h of vasopressor initiation for the treatment of septic shock. Patients were randomly assigned in a 1:1:1 ratio to intravenous nangibotide 0·3 mg/kg per h (low-dose group), nangibotide 1·0 mg/kg per h (high-dose group), or matched placebo, using a computer-generated block randomisation scheme (block size 3). Patients and investigators were masked to treatment allocation. Patients were grouped according to sTREM-1 concentrations at baseline (established from sepsis observational studies and from phase 2a change to data) into high sTREM-1 (≥ 400 pg/mL). The primary outcome was the mean difference in total Sequential Organ Failure Assessment (SOFA) score from baseline to day 5 in the low-dose and high-dose groups compared with placebo, measured in the predefined high sTREM-1 (≥ 400 pg/mL) population and in the overall modified intention-to-treat population. Secondary endpoints included all-cause 28-day mortality, safety, pharmacokinetics, and evaluation of the relationship between TREM-1 activation and treatment response. This study is registered with EudraCT, 2018-004827-36, and Clinicaltrials.gov, NCT04055909.
Findings: Between Nov 14, 2019, and April 11, 2022, of 402 patients screened, 355 were included in the main analysis (116 in the placebo group, 118 in the low-dose group, and 121 in the high-dose group). In the preliminary high sTREM-1 population (total 253 [71%] of 355; placebo 75 [65%] of 116; low-dose 90 [76%] of 118; high-dose 88 [73%] of 121), the mean difference in SOFA score from baseline to day 5 was 0·21 (95% CI -1·45 to 1·87, p=0·80) in the low-dose group and 1·39 (-0·28 to 3·06, p=0·104) in the high-dose group versus placebo. In the overall population, the difference in SOFA score from baseline to day 5 between the placebo group and low-dose group was 0·20 (-1·09 to 1·50; p=0·76),and between the placebo group and the high-dose group was 1·06 (-0·23 to 2·35, p=0·108). In the predefined high sTREM-1 cutoff population, 23 (31%) patients in the placebo group, 35 (39%) in the low-dose group, and 25 (28%) in the high-dose group had died by day 28. In the overall population, 29 (25%) patients in the placebo, 38 (32%) in the low-dose, and 30 (25%) in the high-dose group had died by day 28. The number of treatment-emergent adverse events (111 [96%] patients in the placebo group, 113 [96%] in the low-dose group, and 115 [95%] in the high-dose group) and serious treatment-emergent adverse events (28 [24%], 26 [22%], and 31 [26%]) was similar between all three groups. High-dose nangibotide led to a clinically relevant improvement in SOFA score (of two points or more) from baseline to day 5 over placebo in those with higher cutoff concentrations (≥532 pg/mL) of sTREM-1 at baseline. Low dose nangibotide displayed a similar pattern with lower magnitude of effect across all cutoff values.
Interpretation: This trial did not achieve the primary outcome of improvement in SOFA score at the predefined sTREM-1 value. Future studies are needed to confirm the benefit of nangibotide at higher concentrations of TREM-1 activation.
J Cardiovasc Transl Res. 2023 Oct;16(5):1135-1143. Design and Rationale of the BIOFLOW-DAPT Trial: a Prospective, Randomized, Multicenter Study to Assess the Safety of the Orsiro Mission Stent Compared to the Resolute Onyx Stent in Subjects at High Risk for Bleeding in Combination with 1-Month Dual Antiplatelet Therapy
Antonio Landi, Adrian Wlodarczak, Ralph Tölg, Henning Kelbæk, Jacek Legutko, Stefano Galli, Matthieu Godin, Gabor G Toth, Thibault Lhermusier, Benjamin Honton, Peter Laurenz Dietrich, Francis Stammen, Bert Ferdinande, Johanne Silvain, Davide Capodanno, Guillaume Cayla, Marco Valgimigli; BIOFLOW-DAPT investigators
PMID: 37264295 Abstract
The optimal duration of dual antiplatelet therapy (DAPT) in high bleeding risk (HBR) patients undergoing percutaneous coronary intervention (PCI) with implantation of the Orsiro Mission stent remains unclear. The BIOFLOW-DAPT (clinicaltrials.gov, NCT04137510) trial is a prospective, multi-center, randomized controlled study designed to assess the safety of the Orsiro Mission versus the Resolute Onyx stent in HBR patients. Patients are treated with DAPT (aspirin and a P2Y12 inhibitor) for 1 month, followed by a single antiplatelet therapy (SAPT). The primary endpoint is the composite of cardiac death, myocardial infarction, and definite or probable stent thrombosis at 1 year. With a final sample size of 1948 HBR patients, this study is powered to assess the noninferiority of the Orsiro Mission stent with respect to the primary study endpoint. The BIOFLOW-DAPT is the first randomized clinical trial investigating 1-month DAPT duration in HBR patients after implantation of the Orsiro Mission stent.Trial Registration: ClinicalTrials.gov number, NCT04137510 Study design and key features. Patient selection starts before the index PCI, when consented patients will be randomized to the Orsiro Mission or the Resolute Onyx stent with mandated 1-month DAPT. At 1 month, eligibility is reassessed and if met, patients will discontinue DAPT and continue with P2Y12 inhibitor or aspirin monotherapy. PCI, percutaneous coronary intervention; DAPT, dual antiplatelet therapy; DES, drug-eluting stent; HBR, high bleeding risk; P2Y12i, P2Y12 inhibitor; ST, stent thrombosis.
Ann Surg. 2023 Oct 1;278(4):e885-e892. Current Outcome after Surgery for Type A Aortic Dissection
Fausto Biancari, Tatu Juvonen, Antonio Fiore, Andrea Perrotti, Amélie Hervé, Joseph Touma, Matteo Pettinari, Sven Peterss, Joscha Buech, Angelo M Dell'Aquila, Konrad Wisniewski, Andreas Rukosujew, Till Demal, Lenard Conradi, Marek Pol, Petr Kacer, Francesco Onorati 13, Cecilia Rossetti, Igor Vendramin, Daniela Piani, Mauro Rinaldi, Luisa Ferrante, Eduard Quintana, Robert Pruna-Guillen, Javier Rodriguez Lega, Angel G Pinto, Metesh Acharya, Zein El-Dean, Mark Field, Amer Harky, Francesco Nappi, Sebastien Gerelli, Dario Di Perna, Giuseppe Gatti, Enzo Mazzaro, Stefano Rosato, Peter Raivio, Mikko Jormalainen, Giovanni Mariscalco
PMID: 36912033 Abstract
Objective: The aim of this study was to evaluate the outcomes of different surgical strategies for acute Stanford type A aortic dissection (TAAD).
Summary background data: The optimal extent of aortic resection during surgery for acute TAAD is controversial.
Methods: This is a multicenter, retrospective cohort study of patients who underwent surgery for acute TAAD at 18 European hospitals.
Results: Out of 3902 consecutive patients, 689 (17.7%) died during the index hospitalization. Among 2855 patients who survived 3 months after surgery, 10-year observed survival was 65.3%, while country-adjusted, age-adjusted, and sex-adjusted expected survival was 81.3%, yielding a relative survival of 80.4%. Among 558 propensity score-matched pairs, total aortic arch replacement increased the risk of in-hospital (21.0% vs. 14.9%, P =0.008) and 10-year mortality (47.1% vs. 40.1%, P =0.001), without decreasing the incidence of distal aortic reoperation (10-year: 8.9% vs. 7.4%, P =0.690) compared with ascending aortic replacement. Among 933 propensity score-matched pairs, in-hospital mortality (18.5% vs. 18.0%, P =0.765), late mortality (at 10-year: 44.6% vs. 41.9%, P =0.824), and cumulative incidence of proximal aortic reoperation (at 10-year: 4.4% vs. 5.9%, P =0.190) after aortic root replacement was comparable to supracoronary aortic replacement.
Conclusions: Replacement of the aortic root and aortic arch did not decrease the risk of aortic reoperation in patients with TAAD and should be performed only in the presence of local aortic injury or aneurysm. The relative survival of TAAD patients is poor and suggests that the causes underlying aortic dissection may also impact late mortality despite surgical repair of the dissected aorta.
Eur J Surg Oncol. 2023 Oct;49(10):107001. Laparoscopic cytoreductive surgery and hyperthermic intraperitoneal chemotherapy: Long term oncologic outcomes from the international PSOGI registry
A Arjona-Sanchez, O Aziz, G Passot, G Salti, A Serrano, J Esquivel, K Van der Speeten, A Sommariva, M Kazi, U Shariff, F Martínez-Regueira, P Piso, Y Yonemura, K Turaga, O Sgarbura, A Avanish Saklani, M Tonello, L Rodriguez-Ortiz, M C Vazquez-Borrego, A Romero-Ruiz, O Glehen; International Laparoscopic PSOGI Registry
PMID: 37579618 Abstract
The laparoscopic approach for cytoreductive surgery and hyperthermic intraperitoneal chemotherapy (L-CRS + HIPEC) in highly selected patients was previously reported from the PSOGI registry with a demonstrable reduction in length of stay and post-operative morbidity. This study aims to update this international PSOGI registry with a larger cohort of patients and a longer follow-up period.
Methods: An international registry was designed through a networking database (REDCAP®). All centers performing L-CRS + HIPEC were invited through PSOGI to submit data on their cases. Variables such as demographics, clinical outcomes, and survival were analyzed.
Results: A total of 315 L-CRS + HIPEC cases were provided by 14 worldwide centers. A total of 215 patients were included in the L-CRS + HIPEC group. The median peritoneal cancer index (PCI) was 3 (3-5). The median length of stay was 7 days (5-10) and the major morbidity (Clavien-Dindo ≥3) was 6.1% after 30 days. The 5-year disease-free survival (DFS) per tumor origin was: 94% for PMP-LG, 85% for PMP-HG, 100% for benign multicyst peritoneal mesothelioma (MPM), 37.4% for colonic origin, and 54%(at 3 years) for ovarian origin. The 5 years overall survival (OS) per tumor origin was: 100% for PMP-LG, PMP-HG and MPM; 61% for colonic origin, and 74% (at 3 years) for ovarian origin. In addition, a total of 85 patients were analyzed in the laparoscopic risk-reducing HIPEC (L-RR + HIPEC). The median length of stay was 5 days (4-6) and the major morbidity was 6% after 30 days. The 5-year DFS per tumor origin was: 96% for perforated low grade appendiceal mucinous neoplasm (LAMN II) and 68.1% for colon origin. The 5 years OS per tumor origin was: 98% for LAMN II and 83.5% for colonic origin.
Conclusions: Minimally invasive CRS + HIPEC is a safe procedure for selected patients with peritoneal carcinomatosis in specialized centers. It improves perioperative results while providing satisfactory oncologic outcomes. L-RR + HIPEC represents a promising strategy that could be evaluated in patients with high risk of developing peritoneal carcinomatosis into prospective randomized trials.
Pilot Feasibility Stud. 2023 Oct 31;9(1):181. A randomized controlled trial comparing conservative versus surgical treatment in patients with foot drop due to peroneal nerve entrapment: results of an internal feasibility pilot study Christophe Oosterbos, Sofie Rummens, Kris Bogaerts, Anaïs Van Hoylandt, Sophie Hoornaert, Frank Weyns, Annie Dubuisson, Jeroen Ceuppens, Sophie Schuind, Justus L Groen, Robin Lemmens, Tom Theys
PMID: 37908016 Abstract
Background: Based on the lack of literature to support any treatment strategy in patients with foot drop due to peroneal nerve entrapment, a prospective study randomizing patients between surgery and conservative treatment is warranted. Since studies comparing surgery to no surgery are often challenging, we first examined the feasibility of such a randomized controlled trial.
Methods/design: An internal feasibility pilot study was conducted to assess several aspects of process, resource, management, and scientific feasibility. The main objective was the assessment of the recruitment rate. The criterion to embark on a full study was the recruitment of at least 14 patients in 6 participating centers within 6 months. Cross-over rate, blinding measures, training strategies, and trial assessments were evaluated. The trial was entirely funded by the KCE Trials public funding program of the Belgian Health Care Knowledge Centre (ID KCE19-1232).
Results: The initial duration was prolonged due to the COVID-19 pandemic. Between April 2021 and October 2022, we included 19 patients of which 15 were randomized. Fourteen patients were treated as randomized. One drop-out occurred after randomization, prior to surgery. We did not document any cross-over or accidental unblinding. Training strategies were successful. Patients perceived the quality of life questionnaire as the least relevant assessment. Assessment of ankle dorsiflexion range of motion was prone to interobserver variability. All other trial assessments were adequate.
Neuromodulation. 2023 Oct;26(7):1433-1440. Long-Term Outcome in Patients With Spinal Cord Stimulation for Failed Back Surgery Syndrome: A 20-Year Audit of a Single Center Martine Puylaert, Lynn Nijs, Klaas Buyse, Kris Vissers, Pascal Vanelderen, Margot Nagels, Thomas Daenekindt, Frank Weyns, Dieter Mesotten, Jan Van Zundert, Koen Van Boxem
PMID: 35577695 Abstract
Study design: This is a retrospective, observational study.
Introduction: Spinal cord stimulation (SCS) has found its application in chronic pain treatment, with failed back surgery syndrome (FBSS) as one of the most important indications. However, to date, little is known about the long-term effectiveness of the treatment. The aim of this study is to analyze retrospectively the long-term outcomes of SCS treatment in a single multidisciplinary pain center on predominant radicular pain, using devices of a single manufacturer.
Materials and methods: Patient data on overall patient satisfaction, pain intensity, and adverse events were retrospectively collected in our clinical practice between January 1998 and January 2018, for 191 patients who received a permanent SCS implant. Secondary health measures included the influence of opioid and nicotine use on pain reduction after therapy.
Results: The trial-to-implant ratio was 93.6%. At a mean follow-up of 10.6 years, 78.5% of the patients were satisfied with the treatment outcome, with a significant pain reduction of an average three points on a Numeric Rating Scale. Opioid and nicotine usage did not have a significant link with the pain reduction one year after the treatment. Furthermore, devices had an average battery lifespan of 8.4 years. A total of 248 revisions were recorded. A total of 24 patients (11.7%) acquired an infection; 7 of 204 patients had an infection during the trial period, 2 of 191 patients had an infection in the first postoperative year, and 15 of 191 patients had an infection after the first year. The average time to infection, if not in the first year, was 10.1 years.
Conclusions: A successful long-term outcome regarding pain relief in patients with predominant radicular pain due to FBSS is established with SCS therapy.
J Pers Med. 2023 Oct 18;13(10):1507. Influence of Moisturizers on Skin Microcirculation: An Assessment Study Using Laser Speckle Contrast Imaging
Ignace De Decker, Tanja Klotz, Peter Vu, Henk Hoeksema, Kimberly De Mey, Anse Beeckman, Bob Vermeulen, Marijn Speeckaert, Phillip Blondeel, Marcus Wagstaff, Stan Monstrey, Karel E Y Claes
PMID: 37888118 Abstract
Non-invasive scar management typically involves pressure therapy, hydration with silicones or moisturizers, and UV protection. Moisture loss from scars can lead to hypertrophic scar formation. Pressure therapy reduces blood flow, fibroblast activity, and transforming growth factor beta 1 (TGF-β1) release. This study examined various moisturizers and liquid silicone gel's impact on microcirculation. 40 volunteers participated in a study where superficial abrasions were created to induce trans epidermal water loss (TEWL). Five moisturizers (TEDRA®, TEDRA® NT1, TEDRA® NT3, Alhydran®, Lipikar®) and BAP Scar Care® silicone gel were tested. TEWL, hydration, and blood flow were measured up to 4 h post-application. Results showed that silicone had the least impact on occlusion and hydration. Alhydran® reduced blood flow the most, while Lipikar® increased it the most. TEDRA® NT1 had reduced flow compared to TEDRA® and TEDRA® NT3. All TEDRA® products exhibited high hydration, and all but silicone showed good occlusion. Moisturizers influenced skin microcirculation, with some causing decrease, while others increased flow. However, the clinical impact on scarring remains unclear compared to the evident effects of hydration and occlusion. More research is necessary to study moisturizers alone and with pressure therapy on scars, along with potential adverse effects of increased microcirculation on scars.
N Engl J Med. 2023 Oct 19;389(16):1477-1487. OCT or Angiography Guidance for PCI in Complex Bifurcation Lesions
Niels R Holm, Lene N Andreasen, Omeed Neghabat, Peep Laanmets, Indulis Kumsars, Johan Bennett, Niels T Olsen, Jacob Odenstedt, Pavel Hoffmann, Jo Dens, Saqib Chowdhary, Peter O'Kane, Søren-Haldur Bülow Rasmussen, Matthias Heigert, Ole Havndrup, Jan P Van Kuijk, Simone Biscaglia, Lone J H Mogensen, Loghman Henareh, Francesco Burzotta, Christian H Eek, Darren Mylotte, Miquel S Llinas, Lukasz Koltowski, Paul Knaapen, Slobodan Calic, Nils Witt, Irene Santos-Pardo, Stuart Watkins, Jacob Lønborg, Andreas T Kristensen, Lisette O Jensen, Fredrik Calais, James Cockburn, Andrew McNeice, Olli A Kajander, Ton Heestermans, Stephan Kische, Ashkan Eftekhari, James C Spratt, Evald H Christiansen; OCTOBER Trial Group
PMID: 37634149 Abstract
Background: Imaging-guided percutaneous coronary intervention (PCI) is associated with better clinical outcomes than angiography-guided PCI. Whether routine optical coherence tomography (OCT) guidance in PCI of lesions involving coronary-artery branch points (bifurcations) improves clinical outcomes as compared with angiographic guidance is uncertain.
Methods: We conducted a multicenter, randomized, open-label trial at 38 centers in Europe. Patients with a clinical indication for PCI and a complex bifurcation lesion identified by means of coronary angiography were randomly assigned in a 1:1 ratio to OCT-guided PCI or angiography-guided PCI. The primary end point was a composite of major adverse cardiac events (MACE), defined as death from a cardiac cause, target-lesion myocardial infarction, or ischemia-driven target-lesion revascularization at a median follow-up of 2 years.
Results: We assigned 1201 patients to OCT-guided PCI (600 patients) or angiography-guided PCI (601 patients). A total of 111 patients (18.5%) in the OCT-guided PCI group and 116 (19.3%) in the angiography-guided PCI group had a bifurcation lesion involving the left main coronary artery. At 2 years, a primary end-point event had occurred in 59 patients (10.1%) in the OCT-guided PCI group and in 83 patients (14.1%) in the angiography-guided PCI group (hazard ratio, 0.70; 95% confidence interval, 0.50 to 0.98; P = 0.035). Procedure-related complications occurred in 41 patients (6.8%) in the OCT-guided PCI group and 34 patients (5.7%) in the angiography-guided PCI group.
Conclusions: Among patients with complex coronary-artery bifurcation lesions, OCT-guided PCI was associated with a lower incidence of MACE at 2 years than angiography-guided PCI. (Funded by Abbott Vascular and others; OCTOBER ClinicalTrials.gov number, NCT03171311.).
EClinical Medicine. 2023 Oct 24:65:102304. First randomised controlled trial comparing the sirolimus-eluting bioadaptor with the zotarolimus-eluting drug-eluting stent in patients with de novo coronary artery lesions: 12-month clinical and imaging data from the multi-centre, international, BIODAPTOR-RCT
Shigeru Saito, Johan Bennett, Holger M Nef, Mark Webster, Atsuo Namiki, Akihiko Takahashi, Tsunekazu Kakuta, Seiji Yamazaki, Yoshisato Shibata, Douglas Scott, Mathias Vrolix, Madhav Menon, Helge Möllmann, Nikos Werner, Antoinette Neylon, Zlatko Mehmedbegovic, Pieter C Smits, Marie-Claude Morice, Stefan Verheye; BIOADAPTOR-RCT Collaborators
PMID: 38106564 Abstract
Background: The DynamX™ bioadaptor is the first coronary implant technology with a unique mechanism of unlocking the bioadaptor frame after polymer resorption over 6 months, uncaging the vessel while maintaining a dynamic support to the vessel. It aims to achieve the acute performance of drug-eluting stents (DES) with the advantages of restoration of vessel function.
Methods: This international, single blinded, randomised controlled (1:1) trial compared a sirolimus-eluting bioadaptor with a contemporary zotarolimus-eluting stent (DES) in 34 hospitals in Europe, Japan and New Zealand. Patients with de novo coronary lesions and absence of acute myocardial infarction were enrolled from January 2021 to Feburary 2022. The implantation of the bioadaptor followed the standards of DES. An imaging subset of 100 patients had angiographic and intravascular ultrasound assessments, and 20 patients additionally optical coherence tomography. Data collection will continue through 5 years, we herein report 12-month data based on an intention-to-treat population. This trial is registered at ClinicalTrials.gov (NCT04192747).
Findings: 445 patients were randomised between January 2021 and February 2022. Device, lesion and procedural success rates, and acute gain were similar amongst the groups. The primary endpoint, 12-month target lesion failure, was 1.8% [95% CI: 0.5; 4.6] (n = 4) versus 2.8% [95% CI: 1.0; 6.0] (n = 6), pnon-inferiority 0.001 for the bioadaptor and the DES, respectively (Δ-1.0% [95% CI: -3.3; 1.4]). One definite or probable device thrombosis occurred in each group. The 12-month imaging endpoints showed superior effectiveness of the bioadaptor such as in-device late lumen loss (0.09 mm [SD 0.34] versus 0.25 mm [SD 0.39], p = 0.04), and restored compliance and cyclic pulsatility (%mid in-device lumen area change of 7.5% versus 2.7%, p 0.001).
Interpretation: This is the first randomised controlled trial comparing the novel bioadaptor technology against a contemporary DES. The bioadaptor demonstrated similar acute performance and 12-month clinical outcomes, and superior imaging endpoints including restoration of vessel function.
Funding: The study was funded by Elixir Medical.
Ann Intensive Care. 2023 Nov 21;13(1):113. The effect of higher or lower mean arterial pressure on kidney function after cardiac arrest: a post hoc analysis of the COMACARE and NEUROPROTECT trials
Johanna Laurikkala, Koen Ameloot, Matti Reinikainen, Pieter-Jan Palmers, Cathy De Deyne, Ferdinande Bert, Matthias Dupont, Stefan Janssens, Joseph Dens, Johanna Hästbacka, Pekka Jakkula, Pekka Loisa, Thomas Birkelund, Erika Wilkman, Suvi T Vaara, Markus B Skrifvars
PMID: 37987871 Abstract
Background: We aimed to study the incidence of acute kidney injury (AKI) in out-of-hospital cardiac arrest (OHCA) patients treated according to low-normal or high-normal mean arterial pressure (MAP) targets.
Methods: A post hoc analysis of the COMACARE (NCT02698917) and Neuroprotect (NCT02541591) trials that randomized patients to lower or higher targets for the first 36 h of intensive care. Kidney function was defined using the Kidney Disease Improving Global Outcome (KDIGO) classification. We used Cox regression analysis to identify factors associated with AKI after OHCA.
Results: A total of 227 patients were included: 115 in the high-normal MAP group and 112 in the low-normal MAP group. Eighty-six (38%) patients developed AKI during the first five days; 40 in the high-normal MAP group and 46 in the low-normal MAP group (p = 0.51). The median creatinine and daily urine output were 85 μmol/l and 1730 mL/day in the high-normal MAP group and 87 μmol/l and 1560 mL/day in the low-normal MAP group. In a Cox regression model, independent AKI predictors were no bystander cardiopulmonary resuscitation (p 0.01), non-shockable rhythm (p 0.01), chronic hypertension (p = 0.03), and time to the return of spontaneous circulation (p 0.01), whereas MAP target was not an independent predictor (p = 0.29).
Conclusion: Any AKI occurred in four out of ten OHCA patients. We found no difference in the incidence of AKI between the patients treated with lower and those treated with higher MAP after CA. Higher age, non-shockable initial rhythm, and longer time to ROSC were associated with shorter time to AKI.
Eur J Heart Fail. 2023 Nov;25(11):1899-1922. State-of-the-art document on optimal contemporary management of cardiomyopathies
Petar M Seferović, Marija Polovina, Giuseppe Rosano, Biykem Bozkurt, Marco Metra, Stephane Heymans, Wilfried Mullens, Johann Bauersachs, Karen Sliwa Rudolf A de Boer, Dimitrios Farmakis, Thomas Thum, Iacopo Olivotto, Claudio Rapezzi, Aleš Linhart, Domenico Corrado, Carsten Tschöpe, Ivan Milinković, Antoni Bayes Genis, Gerasimos Filippatos, Andre Keren, Milika Ašanin, Gordana Krljanac, Ružica Maksimović , Hadi Skouri, Tuvia Ben Gal, Brenda Moura, Maurizio Volterrani, Magdy Abdelhamid, Yuri Lopatin, Ovidiu Chioncel, Andrew J S Coats
PMID: 37470300 Abstract
Cardiomyopathies represent significant contributors to cardiovascular morbidity and mortality. Over the past decades, a progress has occurred in characterization of the genetic background and major pathophysiological mechanisms, which has been incorporated into a more nuanced diagnostic approach and risk stratification. Furthermore, medications targeting core disease processes and/or their downstream adverse effects have been introduced for several cardiomyopathies. Combined with standard care and prevention of sudden cardiac death, these novel and emerging targeted therapies offer a possibility of improving the outcomes in several cardiomyopathies. Therefore, the aim of this document is to summarize practical approaches to the treatment of cardiomyopathies, which includes the evidence-based novel therapeutic concepts and established principles of care, tailored to the individual patient aetiology and clinical presentation of the cardiomyopathy. The scope of the document encompasses contemporary treatment of dilated, hypertrophic, restrictive and arrhythmogenic cardiomyopathy. It was based on an expert consensus reached at the Heart Failure Association online Workshop, held on 18 March 2021.
Catheter Cardiovasc Interv. 2023 Nov;102(5):864-877. Wire-based antegrade dissection re-entry technique for coronary chronic total occlusions percutaneous revascularization: Experience from the ERCTO Registry
Alfredo R Galassi, Giuseppe Vadalà, Laura Maniscalco, Gabriele Gasparini, Dens Jo, Nenad Z Bozinovic, Sevket Gorgulu, Thomas Gehrig, Luca Grancini, Imre Ungi, Eugenio La Scala, Andrew Ladwiniec, Sinisa Stojkovic, Alessio La Manna, Carlo Tumscitz, Simon Elhadad, Gerald S Werner, Georgios Sianos, Roberto Garbo, Mauro Carlino, Kambis Mashayekhi, Carlo di Mario
PMID: 37668012 Abstract
Background: The recent development and widespread adoption of antegrade dissection re-entry (ADR) techniques have been underlined as one of the antegrade strategies in all worldwide CTO consensus documents. However, historical wire-based ADR experience has suffered from disappointing long-term outcomes.
Aims: Compare technical success, procedural success, and long-term outcome of patients who underwent wire-based ADR technique versus antegrade wiring (AW).
Methods: One thousand seven hundred and ten patients, from the prospective European Registry of Chronic Total Occlusions (ERCTO), underwent 1806 CTO procedures between January 2018 and December 2021, at 13 high-volume ADR centers. Among all 1806 lesions attempted by the antegrade approach, 72% were approached with AW techniques and 28% with wire-based ADR techniques.
Results: Technical and procedural success rates were lower in wire-based ADR than in AW (90.3% vs. 96.4%, p 0.001; 87.7% vs. 95.4%, p 0.001, respectively); however, wire-based ADR was used successfully more often in complex lesions as compared to AW (p = 0.017). Wire-based ADR was used in most cases (85%) after failure of AW or retrograde procedures. At a mean clinical follow-up of 21 ± 15 months, major adverse cardiac and cerebrovascular events (MACCEs) did not differ between AW and wire-based ADR (12% vs. 15.1%, p = 0.106); both AW and wire-based ADR procedures were associated with significant symptom improvements.
Conclusions: As compared to AW, wire-based ADR is a reliable and effective strategy successfully used in more complex lesions and often after the failure of other techniques. At long-term follow-up, patient's MACCEs and symptoms improvement were similar in both antegrade techniques.
Eur J Hum Genet. 2023 Nov;31(11):1323-1332. Tools to differentiate between Filamin C and Titin truncating variant carriers: value of MRI
Johanna Jacobs, Lucas Van Aelst, Jeroen Breckpot, Anniek Corveleyn, Cuno Kuiperi, Matthias Dupont, Ward Heggermont, Katrien De Vadder, Rik Willems, Johan Van Cleemput, Jan G Bogaert, Tomas Robyns
PMID: 37032351 Abstract
Whereas truncating variants of the giant protein Titin (TTNtv) are the main cause of familial dilated cardiomyopathy (DCM), recently Filamin C truncating variants (FLNCtv) were identified as a cause of arrhythmogenic cardiomyopathy (ACM). Our aim was to characterize and compare clinical and MRI features of TTNtv and FLNCtv in the Belgian population. In index patients referred for genetic testing of ACM/DCM, FLNCtv and TTNtv were found in 17 (3.6%) and 33 (12.3%) subjects, respectively. Further family cascade screening yielded 24 and 19 additional truncating variant carriers in FLNC and TTN, respectively. The main phenotype was ACM in FLNCtv carriers whereas TTNtv carriers showed either an ACM or DCM phenotype. Non-sustained Ventricular Tachycardia was frequent in both populations. MRI data, available in 28/40 FLNCtv and 32/52 TTNtv patients, showed lower Left Ventricular (LV) ejection fraction and lower LV strain in TTNtv patients (p 0.01). Conversely, both the frequency (68% vs 22%) and extent of non-ischemic myocardial late gadolinium enhancement (LGE) was significantly higher in FLNCtv patients (p 0.01). Hereby, ring-like LGE was found in 16/19 (84%) FLNCtv versus 1/7 (14%) of TTNtv patients (p 0.01). In conclusion, a large number of FLNCtv and TTNtv patients present with an ACM phenotype but can be separated by cardiac MRI. Whereas FLNCtv patients often have extensive myocardial fibrosis, typically following a ring-like pattern, LV dysfunction without or limited replacement fibrosis is the common TTNtv phenotype.
BMC Med Res Methodol. 2023 Nov 24;23(1):276. Multiclass risk models for ovarian malignancy: an illustration of prediction uncertainty due to the choice of algorithm
Ashleigh Ledger, Jolien Ceusters, Lil Valentin, Antonia Testa, Caroline Van Holsbeke, Dorella Franchi, Tom Bourne, Wouter Froyman, Dirk Timmerman, Ben Van Calster
PMID: 38001421 Abstract
Background: Assessing malignancy risk is important to choose appropriate management of ovarian tumors. We compared six algorithms to estimate the probabilities that an ovarian tumor is benign, borderline malignant, stage I primary invasive, stage II-IV primary invasive, or secondary metastatic.
Methods: This retrospective cohort study used 5909 patients recruited from 1999 to 2012 for model development, and 3199 patients recruited from 2012 to 2015 for model validation. Patients were recruited at oncology referral or general centers and underwent an ultrasound examination and surgery ≤ 120 days later. We developed models using standard multinomial logistic regression (MLR), Ridge MLR, random forest (RF), XGBoost, neural networks (NN), and support vector machines (SVM). We used nine clinical and ultrasound predictors but developed models with or without CA125.
Results: Most tumors were benign (3980 in development and 1688 in validation data), secondary metastatic tumors were least common (246 and 172). The c-statistic (AUROC) to discriminate benign from any type of malignant tumor ranged from 0.89 to 0.92 for models with CA125, from 0.89 to 0.91 for models without. The multiclass c-statistic ranged from 0.41 (SVM) to 0.55 (XGBoost) for models with CA125, and from 0.42 (SVM) to 0.51 (standard MLR) for models without. Multiclass calibration was best for RF and XGBoost. Estimated probabilities for a benign tumor in the same patient often differed by more than 0.2 (20% points) depending on the model. Net Benefit for diagnosing malignancy was similar for algorithms at the commonly used 10% risk threshold, but was slightly higher for RF at higher thresholds. Comparing models, between 3% (XGBoost vs. NN, with CA125) and 30% (NN vs. SVM, without CA125) of patients fell on opposite sides of the 10% threshold.
Conclusion: Although several models had similarly good performance, individual probability estimates varied substantially.
Int J Cardiol. 2023 Nov 15:391:131274. Clinical outcomes of coronary intravascular lithotripsy in patients with stent failure (COIL registry)
Michał Kuzemczak, Janusz Lipiecki, Visvesh Jeyalan, Hicham Farhat, Paweł Kleczyński, Jacek Legutko, Lennert Minten, Johan Bennett, Ella Poels, Joseph Dens, Ioakim Spyridopoulos, Vijay Kunadian, Tomasz Pawłowski, Robert Gil, Mohaned Egred, Azfar Zaman, Mohammad Alkhalil
PMID: 37598907 Abstract
Background: Intravascular lithotripsy (IVL) has been demonstrated to be an effective treatment of calcified de novo coronary lesions. Safety data on the use of IVL within stented segments are lacking. We sought to evaluate the safety, feasibility, and long-term outcomes of IVL in patients with stent failure.
Methods: This was a retrospective multi-centre registry that included consecutive patients with stent failure who had undergone IVL treatment. The primary efficacy endpoint was procedural success defined as residual stenosis 30% (determined by quantitative coronary angiography analysis) in patients who survived hospital admission without in-hospital adverse events. Major adverse cardiovascular events (MACE) were defined as the composite endpoints of cardiovascular death, spontaneous myocardial infarction, and target vessel revascularisation at one-year follow up.
Results: 102 patients were included in this study. Mean age was 73 ± 9 years and 81% were male. The duration from previous stent implantation and IVL treatment was 24 (interquartile range 7-76) months, of which 10.8% received IVL for acute under-expanded stent. IVL treatment allowed significant improvement in both minimal lumen diameter (1.14 ± 0.60 to 2.53 ± 0.59, P 0.001) and degree of stenosis (66.8 ± 19.9 to 20.3 ± 11.3%, P 0.001). The rate of procedural success was 78.4% (80/102 of patients). The one-year MACE was 15.7%. Ostial disease (HR 5.16; 95% CI 1.19 to 22.33; P = 0.028) and lesion length (HR 1.05; 95% CI 1.01 to 1.10; P = 0.010) were independently associated with one-year MACE.
Conclusions: In patients with stent failure, IVL is a safe and feasible treatment for this high-risk group.
Circ Arrhythm Electrophysiol. 2023 Nov;16(11):e012043. No Effect of Continued Antiarrhythmic Drug Treatment on Top of Optimized Pulmonary Vein Isolation in Patients With Persistent Atrial Fibrillation: Results From the POWDER-AF2 Trial
Anthony Demolder, Louisa O'Neill, Milad El Haddad, Daniel Scherr, Johan Vijgen, Michael Wolf, Benjamin Berte, Felipe Bisbal, Arne Johannessen, Maximo Rivero-Ayerza, Tom De Potter, Benjamin De Becker, Jean-Benoît le Polain de Waroux, Sebastien Knecht, Rene Tavernier, Mattias Duytschaever
PMID: 37921006 Abstract
Background: In patients with persistent atrial fibrillation (PersAF), catheter ablation aiming for pulmonary vein isolation (PVI) is associated with moderate clinical effectiveness. We investigated the benefit of continuing previously ineffective class 1C or 3 antiarrhythmic drug therapy (ADT) in the setting of a standardized PVI-only ablation strategy.
Methods: In this multicenter, randomized controlled study, patients with PersAF (≥7 days and 12 months) despite ADT were prospectively randomized 1:1 to PVI with ADT continued versus discontinued beyond the blanking period (ADT ON versus ADT OFF). Standardized catheter ablation was performed aiming for durable isolation with stable, contiguous, and optimized radio frequency applications encircling the pulmonary veins (CLOSE protocol). Clinical visits and 1-to-7-day Holter were performed at 3, 6, and 12 months. The primary end point was any documented atrial tachyarrhythmia lasting >30 seconds beyond 3 months. Prospectively defined secondary end points included repeat ablations, unscheduled arrhythmia-related visits, and quality of life among groups.
Results: Of 200 PersAF patients, 98 were assigned to ADT OFF and 102 to ADT ON. The longest atrial fibrillation episode qualifying for PersAF was 28 (10-90) versus 30 (11-90) days. Clinical characteristics and procedural characteristics were similar. Recurrence of atrial tachyarrhythmia was comparable in both groups (20% OFF versus 21.2% ON). No differences were observed in repeat ablations and unscheduled arrhythmia-related visits. Marked improvement in quality of life was observed in both groups.
Conclusions: In patients with PersAF, there is no benefit in continuing previously ineffective ADT beyond the blanking period after catheter ablation. The high success rate of PVI-only might be explained by the high rate of durable isolation after optimized PVI and the early stage of PersAF (POWDER-AF2).
J Card Fail. 2023 Nov;29(11):1522-1530. Fewer Worsening Heart Failure Events With HeartLogic on top of Standard Care: a Propensity-Matched Cohort Analysis
Michelle Feijen, Monika Beles, Yan Zhi Tan, Audrey Cordon, Matthias Dupont, Roderick W Treskes, Maria-Luce Caputo, Koen VAN Bockstal, Angelo Auricchio, Anastasia D Egorova, Edith Maes, Saskia L M A Beeres, Ward A Heggermont
PMID: 37220824 Abstract
Background: The implantable cardiac defibrillator-based HeartLogic algorithm aims to detect impending fluid retention in patients with heart failure (HF). Studies show that HeartLogic is safe to integrate into clinical practice. The current study investigates whether HeartLogic provides clinical benefit on top of standard care and device telemonitoring in patients with HF.
Methods: A multicenter, retrospective, propensity-matched cohort analysis was performed in patients with HF and implantable cardiac defibrillators, and it compared HeartLogic to conventional telemonitoring. The primary endpoint was the number of worsening HF events. Hospitalizations and ambulatory visits due to HF were also evaluated.
Results: Propensity score matching yielded 127 pairs (median age 68 years, 80% male). Worsening HF events occurred more frequently in the control group (2; IQR 0-4) compared to the HeartLogic group (1; IQR 0-3; P = 0.004). The number of HF hospitalization days was higher in controls than in the HeartLogic group (8; IQR 5-12 vs 5; IQR 2-7; P = 0.023), and ambulatory visits for diuretic escalation were more frequent in the control group than in the HeartLogic group (2; IQR 0-3 vs 1; IQR 0-2; P = 0.0001).
Conclusion: Integrating the HeartLogic algorithm in a well-equipped HF care path on top of standard care is associated with fewer worsening HF events and shorter duration of fluid retention-related hospitalizations.
Children (Basel). 2023 Nov 28;10(12):1866. Testing a Home Solution for Preparing Young Children for an Awake MRI: A Promising Smartphone Application
Sam Geuens, Jurgen Lemiere, Jessica Nijs, Marlies Treunen, Michael Aertsen, Jaan Toelen, Greet Pauwels, Kate Sauer, Marlies Potoms, Sofie Van Cauter, Leen Wouters, Kathrin Hohlbaum, Marie Sjölinder, Olov Ståhl, Gunnar Buyse, Philippe Demaerel, Barbara Weyn
PMID: 38136068 Abstract
Thanks to its non-invasive nature and high-resolution imaging capabilities, magnetic resonance imaging (MRI) is a valuable diagnostic tool for pediatric patients. However, the fear and anxiety experienced by young children during MRI scans often result in suboptimal image quality and the need for sedation/anesthesia. This study aimed to evaluate the effect of a smartphone application called COSMO@home to prepare children for MRI scans to reduce the need for sedation or general anesthesia. The COSMO@home app was developed incorporating mini-games and an engaging storyline to prepare children for learning goals related to the MRI procedure. A multicenter study was conducted involving four hospitals in Belgium. Eligible children aged 4-10 years were prepared with the COSMO@home app at home. Baseline, pre-scan, and post-scan questionnaires measured anxiety evolution in two age groups (4-6 years and 7-10 years). Eighty-two children participated in the study, with 95% obtaining high-quality MRI images. The app was well-received by children and parents, with minimal technical difficulties reported. In the 4-6-year-old group (N = 33), there was a significant difference between baseline and pre-scan parent-reported anxiety scores, indicating an increase in anxiety levels prior to the scan. In the 7-10-year-old group (N = 49), no significant differences were observed between baseline and pre-scan parent-reported anxiety scores. Overall, the COSMO@home app proved to be useful in preparing children for MRI scans, with high satisfaction rates and successful image outcomes across different hospitals. The app, combined with minimal face-to-face guidance on the day of the scan, showed the potential to replace or assist traditional face-to-face training methods. This innovative approach has the potential to reduce the need for sedation or general anesthesia during pediatric MRI scans and its associated risks and improve patient experience.
Sci Rep. 2023 Nov 7;13(1):19322. Comprehensive antibody and cytokine profiling in hospitalized COVID-19 patients in relation to clinical outcomes in a large Belgian cohort
Pieter Ruytinx, Patrick Vandormael, Judith Fraussen, Zoë Pieters, Stef Thonissen, Niels Hellings, Piet Stinissen, Ina Callebaut, Joris Penders, Karolien Vanhove, Davy Kieffer, Jean-Luc Rummens, Tom Valkenborgh, Peter Messiaen, Björn Stessel, Dieter Mesotten, Veerle Somers
PMID: 37935729 Abstract
The immune response in patients with Coronavirus Disease 2019 (COVID-19) is highly variable and is linked to disease severity and mortality. However, antibody and cytokine responses in the early disease stage and their association with disease course and outcome are still not completely understood. In this large, multi-centre cohort study, blood samples of 434 Belgian COVID-19 hospitalized patients with different disease severities (ranging from asymptomatic/mild to critically ill) from the first wave of the COVID-19 pandemic were obtained. Baseline antibody and cytokine responses were characterized and associations with several clinical outcome parameters were determined. Anti-spike immunoglobulin (Ig)G and IgM levels were elevated in patients with a more severe disease course. This increased baseline antibody response however was associated with decreased odds for hospital mortality. Levels of the pro-inflammatory cytokines IL-6, IP-10 and IL-8, the anti-inflammatory cytokine IL-10 and the antiviral cytokines IFN-α, IFN-β and IFN-λ1 were increased with disease severity. Remarkably, we found significantly lower levels of IFN-λ2,3 in critically ill patients compared to patients of the moderate and severe disease category. Finally, levels of IL-8, IL-6, IP-10, IL-10, IFN-α, IFN-β, IFN-γ and IFN-λ1 at baseline were positively associated with mortality, whereas higher IFN-λ2,3 levels were negatively associated with mortality.
