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1. Surgery Versus Thrombolytic Therapy for the Management of Left‐Sided Prosthetic Valve Thrombosis Without Hemodynamic Compromise: A Systematic Review and Meta‐Analysis

Author

Romain Chopard, Charles Vidoni, Matthieu Besutti, Maria Ismail, Fiona Ecarnot, Baptiste Favoulet, Marc Badoz, François Schiele, Andrea Perrotti, and Nicolas Meneveau

Subjects
meta‐analysis, prosthetic valve thrombosis, surgery, thrombolysis, Diseases of the circulatory (Cardiovascular) system, RC666-701
Abstract

Background The optimal strategy in prosthetic heart valve thrombosis (PVT) remains controversial, with no randomized trials and conflicting observational data. We performed a systematic review and meta‐analysis of evidence comparing systemic thrombolysis and cardiac surgery in PVT. Methods and Results We searched PubMed, the Cochrane Library, and Embase for studies on treatment strategies in patients with left‐sided PVT since 2000. The primary outcome was death, and the secondary outcomes were major bleeding and thromboembolism during follow‐up (International Prospective Register of Systematic Reviews No. CRD42022384092). We identified 2298 studies, of which 16 were included, comprising 1389 patients with PVT (mean age, 50.4±9.3 years; 60.0% women). Among them, 67.2% were New York Heart Association stage III/IV at admission. Overall, 48.1% were treated with systemic thrombolysis and 51.9% with cardiac surgery. The mortality rate was 10.8% in the thrombolysis group and 15.3% in the surgery group. The pooled risk difference for death with systemic thrombolysis was 1.13 (exact CI, 0.74–1.79; ζ2=0.89; P

Published
2024
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2. Incidence of atrial fibrillation in cryptogenic stroke with patent foramen ovale closure: protocol for the prospective, observational PFO-AF study

Author

Fiona Ecarnot, Nicolas Meneveau, Gilles Rioufol, Charles Guenancia, Romain Chopard, Marc Badoz, François Derimay, Guillaume Serzian, Matthieu Besutti, and Pierre Frey

Subjects
Medicine
Abstract

Introduction After closure of patent foramen ovale (PFO) due to stroke, atrial fibrillation (AF) occurs in up to one in five patients. However, data are sparse regarding the possible pre-existence of AF in these patients prior to PFO closure, and about recurrence of AF in the long term after the procedure. No prospective study to date has investigated these topics in patients with implanted cardiac monitor (ICM). The PFO-AF study (registered with ClinicalTrials.gov under the number NCT04926142) will investigate the incidence of AF occurring within 2 months after percutaneous closure of PFO in patients with prior stroke. AF will be identified using systematic ICM. Secondary objectives are to assess incidence and burden of AF in the 2 months prior to, and up to 2 years after PFO closure.Methods and analysis Prospective, multicentre, observational study including 250 patients with an indication for PFO closure after stroke, as decided by interdisciplinary meetings with cardiologists and neurologists. Patients will undergo implantation of a Reveal Linq device (Medtronic). Percutaneous PFO closure will be performed 2 months after device implantation. Follow-up will include consultation, ECG and reading of ICM data at 2, 12 and 24 months after PFO closure. The primary endpoint is occurrence of AF at 2 months, defined as an episode of AF or atrial tachycardia/flutter lasting at least 30 s, and recorded by the ICM and/or any AF or atrial tachycardia/flutter documented on ECG during the first 2 months of follow-up.Ethics and dissemination The study was approved by the Ethics Committee ‘Comité de Protection des Personnes (CPP) Sud-Méditerranéen III’ on 2 June 2021 and registered with ClinicalTrials.gov (NCT04926142). Findings will be presented in national and international congresses and peer-reviewed journals.Trial registration number NCT04926142.

Published
2023
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3. Incidence and management of atrioventricular conduction disorders in new-onset left bundle branch block after TAVI: A prospective multicenter study

Author

Grégoire Massoullié, Sylvain Ploux, Géraud Souteyrand, Pierre Mondoly, Bruno Pereira, Nicolas Amabile, Frédéric Jean, Didier Irles, Jacques Mansourati, Nicolas Combaret, Alexis Mechulan, Marc Badoz, Antoine Da Costa, Pascal Defaye, Pascal Motreff, Guillaume Clerfond, Pierre Bordachar, and Romain Eschalier

Subjects
Physiology (medical), Cardiology and Cardiovascular Medicine
Published
2023

4. An Original Risk Score to Predict Early Major Bleeding in Acute Pulmonary Embolism

Author

Francois Schiele, Gregory Piazza, Gilles Capellier, Mathieu Besutti, Marc Badoz, Romain Chopard, Nicolas Meneveau, Nicolas Falvo, and Fiona Ecarnot

Subjects
Pulmonary and Respiratory Medicine, medicine.medical_specialty, Framingham Risk Score, Anemia, business.industry, Bleed, Critical Care and Intensive Care Medicine, medicine.disease, Logistic regression, Pulmonary embolism, Brier score, Internal medicine, medicine, Derivation, Cardiology and Cardiovascular Medicine, business, Major bleeding
Abstract

Background Improved prediction of the risk of early major bleeding in pulmonary embolism (PE) is needed to optimize acute management. Research Question Does a simple scoring system predict early major bleeding in acute PE patients, identifying patients with either high or low probability of early major bleeding? Study Design and Methods From a multicenter prospective registry including 2,754 patients, we performed post hoc multivariable logistic regression analysis to build a risk score to predict early (up to hospital discharge) major bleeding events. We validated the endpoint model internally, using bootstrapping in the derivation dataset by sampling with replacement for 500 iterations. Performances of this novel score were compared with that of the VTE-BLEED (Venous Thrombo-Embolism Bleed), RIETE (Registro informatizado de la enfermedad tromboembolica en Espana; Computerized Registry of Patients with Venous Thromboembolism), and BACS (Bleeding, Age, Cancer, and Syncope) models. Results Multivariable regression identified three predictors for the occurrence of 82 major bleeds (3.0%; 95% CI, 2.39%-3.72%): Syncope (+1.5); Anemia, defined as hemoglobin 2.5 points). Observed bleeding rates increased with increasing risk group, from 0.97% (95% CI, 0.53%-1.62%) in the low-risk to 8.93% (95% CI, 6.15%-12.44%) in the high-risk group. C-index was 0.74 (95% CI, 0.73-0.76) and Brier score 0.028 in the derivation cohort. Similar values were calculated from internal bootstrapping. Performance of the PE-SARD score was better than that observed with the VTE-BLEED, RIETE, and BACS scores, leading to a high proportion of bleeding-risk reclassification in patients who bled and those who did not. Interpretation The PE-SARD bleeding risk score is an original, user-friendly score to estimate risk of early major bleeding in patients with acute PE.

Published
2021

5. MP-453092-9 PROGNOSTIC SIGNIFICANCE OF SUSTAINED VENTRICULAR ARRHYTHMIAS OCCURRING UNDER WEARABLE CARDIOVERTER DEFIBRILLATOR PROTECTION IN POST-INFARCT PATIENTS WITH A LEFT VENTRICULAR DYSFUNCTION

Author

Mathieu ECHIVARD, Jean-Marc Sellal, Chloé Ziliox, Eloi Marijon, Pierre BORDACHAR, christelle marquie, Clemence Docq, Romain Eschalier, Baptiste Maille, JEAN-CLAUDE DEHARO, Dominique Babuty, estelle gandjbakhch, Antoine Da Costa, Olivier Piot, Damien Minois, JEAN BAPTISTE GOURRAUD, PIERRE MONDOLY, Philippe Maury, SERGE BOVEDA, Jean-Luc Pasquie, Raphael Martins, Christophe Leclercq, Charles Guenancia, Gabriel LAURENT, Mathieu Becker, JULIEN BERTRAND, Philippe Chevalier, Vladimir Manenti, MACIEJ KUBALA, PASCAL DEFAYE, Peggy Jacon, Antoine Desbiolles, Marc Badoz, Laurence Jesel, Nicolas Lellouche, Paul Milliez, Paul Ollitrault, Samir Fareh, Matthieu Bercker, Jacques Mansourati, Benoit Guy Moyat, Nicolas Luconi, Jean-Pierre Chabert, null pierre winum, Frederic Anselme, Antoine Leenhardt, Fabrice Extramiana, Camille Delahaye, François Jourda, Olivier Bizeau, Mathieu Nasarre, ARNAUD OLIVIER, Stéphane Fromentin, THIBAULT VILLEMIN, Olivier Levavasseur, Néfissa Hammache, Isabelle Magnin, Hugues Blangy, Nicolas Sadoul, Kévin Duarte, Nicolas Girerd, and Christian de Chillou

Subjects
Physiology (medical), Cardiology and Cardiovascular Medicine
Published
2023

6. Sex Differences in Outcomes of Tetralogy of Fallot Patients With Implantable Cardioverter-Defibrillators

Author

Victor Waldmann, Abdeslam Bouzeman, Guillaume Duthoit, Linda Koutbi, Francis Bessière, Fabien Labombarda, Christelle Marquié, Jean-Baptiste Gourraud, Pierre Mondoly, Jean Marc Sellal, Pierre Bordachar, Alexis Hermida, Alain Al Arnaout, Frédéric Anselme, Caroline Audinet, Yvette Bernard, Serge Boveda, Sok Sithikun Bun, Morgane Chassignolle, Gaël Clerici, Antoine Da Costa, Maxime de Guillebon, Pascal Defaye, Nathalie Elbaz, Romain Eschalier, Rodrigue Garcia, Charles Guenancia, Benoit Guy-Moyat, Franck Halimi, Didier Irles, Laurence Iserin, François Jourda, Magalie Ladouceur, Philippe Lagrange, Mikael Laredo, Jacques Mansourati, Grégoire Massoulié, Amel Mathiron, Philippe Maury, Anne Messali, Kumar Narayanan, Cédric Nguyen, Sandro Ninni, Marie-Cécile Perier, Bertrand Pierre, Penelope Pujadas, Frédéric Sacher, Pascal Sagnol, Ardalan Sharifzadehgan, Camille Walton, Pierre Winum, Cyril Zakine, Laurent Fauchier, Raphaël Martins, Jean-Luc Pasquié, Jean-Benoit Thambo, Xavier Jouven, Nicolas Combes, Eloi Marijon, Chrystelle Akret, Jean-Paul Albenque, Vincent Algalarrondo, Christine Alonso, Denis Amet, Frédéric Ansselme, Anouk Asselin, Nicolas Badenco, Hugues Bader, Marc Badoz, Pierre Baudinaud, Nathalie Behar, Mouna Ben Kilani, Géraldine Bertaux, Cathy Bertrand, Francis Bessiere, Hughes Blangy, Damien Bonnet, Pierre Bordchar, Paul Bru, Adrien Carabelli, Christèle Cardin, Bruno Cauchemez, Tej Chalbia, Laure Champ-Rigot, Thomas Chastre, Philippe Chevallier, Nicolas Clementy, Stéphane Combes, Christian De Chillou, Maxime De Guillebon, Bruno Degand, Jean-Claude Deharo, Nicolas Derval, Sylvie Di Filippo, Guillaume Domain, Antoine Dompnier, Arnaud Dulac, Alexandre Duparc, D Cécile Duplantier, Rim El Bouazzaoui, Bogdan Enache, Fabrice Extramiana, Pierre Fiorello, Pierre Frey, Luc Freysz, Vincent Galand, Estelle Gandjbakhch, Kevin Gardey, Olivier Geoffroy, Bénédicte Godin, Samuel Goussot, Caroline Grimard, Jean-Baptiste Guichard, Michel Haissaguerre, David Hamon, Sébastien Hascoet, Karim Hasni, Jean-Sylvain Hermida, Françoise Hidden-Lucet, Mélèze Hocini, Jérome Hourdain, Peggy Jacon, Gaël Jauvert, Frédéric Jean, Nicolas Johnson, Pierre Khattar, Ziad Khoueiry, Rita Koutbi, Guillaume Laborie, Gabriel Lactu, Pierre-Marc Lallemand, Gabriel Laurent, Thomas Lavergne, Arnaud Lazarus, Laurianne Le Gloan, Christophe Leclercq, Antoine Leenhardt, Nicolas Lellouche, Christophe Loose, Philippe Mabo, Alice Maltret, Franck Mandel, Christelle Marquie, Carole Maupain, Antoine Milhelm, Paul Milliez, Adrian Mirolo, Ghassan Moubarak, Stéphane Mourot, Jacky Ollitrault, Pierre Ollitrault, Akli Otmani, Jean-Luc Pasquie, Dominique Pavin, Séverinne Philibert, Damien Poindron, Charlotte Potelle, Vincent Probst, Paul Puie, Anne Rollin, Cécile Romeyer-Bouchard, Nicolas Sadoul, Audrey Sagnard, Arnaud Savoure, Didier Scarlatti, Fabien Squara, Nikita Tanese, Jean Benoit Thambo, Olivier Thomas, Emie Varlet, Sandrine Venier, Quentin Voglimacci Stephanopoli, Xavier Waintraub, Françoise Wiart, Alexandre Zhao, Amir Zouaghi, Paris-Centre de Recherche Cardiovasculaire (PARCC (UMR_S 970/ U970)), Hôpital Européen Georges Pompidou [APHP] (HEGP), Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP)-Hôpitaux Universitaires Paris Ouest - Hôpitaux Universitaires Île de France Ouest (HUPO)-Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP)-Hôpitaux Universitaires Paris Ouest - Hôpitaux Universitaires Île de France Ouest (HUPO)-Institut National de la Santé et de la Recherche Médicale (INSERM)-Université Paris Cité (UPCité), CHU Pitié-Salpêtrière [AP-HP], Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP)-Sorbonne Université (SU), CHU Pontchaillou [Rennes], Laboratoire Traitement du Signal et de l'Image (LTSI), Université de Rennes (UR)-Institut National de la Santé et de la Recherche Médicale (INSERM), Physiologie & médecine expérimentale du Cœur et des Muscles [U 1046] (PhyMedExp), Institut National de la Santé et de la Recherche Médicale (INSERM)-Centre National de la Recherche Scientifique (CNRS)-Université de Montpellier (UM), Centre Hospitalier Régional Universitaire [Montpellier] (CHRU Montpellier), Clinique Pasteur, Clinique Pasteur [Toulouse], and This work was supported by the French Institute of Health and Medical Research, Fédération Française de Cardiologie, and Société Française de Cardiologie. The authors have reported that they have no relationships relevant to the contents of this paper to disclose.

Subjects
Male, Adult, Heart Defects, Congenital, Sex Characteristics, sudden death, Middle Aged, congenital heart disease, Defibrillators, Implantable, Cohort Studies, implantable cardioverter-defibrillator, Death, Sudden, Cardiac, Tetralogy of Fallot, sex, Humans, [SDV.SPEE]Life Sciences [q-bio]/Santé publique et épidémiologie, Female, women, ventricular arrhythmia
Abstract

International audience; Background: Women with congenital heart disease at high risk for sudden cardiac death have been poorly studied thus far.Objectives: The aim of this study was to assess sex-related differences in patients with tetralogy of Fallot (TOF) and implantable cardioverter-defibrillators (ICDs).Methods: Data were analyzed from the DAI-T4F (French National Registry of Patients With Tetralogy of Fallot and Implantable Cardioverter Defibrillator) cohort study, which has prospectively enrolled all patients with TOF with ICDs in France since 2010. Clinical events were centrally adjudicated by a blinded committee.Results: A total of 165 patients (mean age 42.2 ± 13.3 years) were enrolled from 40 centers, including 49 women (29.7%). Among the 9,692 patients with TOF recorded in the national database, the proportion of women with ICDs was estimated to be 1.1% (95% CI: 0.8%-1.5%) vs 2.2% (95% CI: 1.8%-2.6%) in men (P < 0.001). The clinical profiles of patients at implantation, including the number of risk factors for ventricular arrhythmias, were similar between women and men. During a median follow-up period of 6.8 years (IQR: 2.5-11.4 years), 78 patients (47.3%) received at least 1 appropriate ICD therapy, without significant difference in annual incidences between women (12.1%) and men (9.9%) (HR: 1.22; 95% CI: 0.76-1.97; P = 0.40). The risk for overall ICD-related complications was similar in women and men (HR: 1.33; 95% CI: 0.81-2.19; P = 0.30), with 24 women (49.0%) experiencing at least 1 complication.Conclusions: Our findings suggest that women with TOF at high risk for sudden cardiac death have similar benefit/risk balance from ICD therapy compared with men. Whether ICD therapy is equally offered to at-risk women vs men warrants further evaluation in TOF as well as in other congenital heart disease populations. (French National Registry of Patients With Tetralogy of Fallot and Implantable Cardioverter Defibrillator [DAI-T4F]; NCT03837574)

Published
2022

7. Efficacy and safety of the new TightRail™ mechanical sheath for transvenous lead extraction: Results of a French multicenter study

Author

Adrien Artus, Jacques Mansourati, Marjaneh Fatemi, Bertrand Pierre, Alexandre Schatz, Marc Badoz, Gabriel Laurent, Charles Guenancia, and Fabien Garnier

Subjects
Male, Pacemaker, Artificial, Treatment Outcome, Physiology (medical), Humans, Female, Cardiology and Cardiovascular Medicine, Device Removal, Defibrillators, Implantable, Retrospective Studies
Abstract

The aim of this study was to assess the safety and efficacy of the TightRail™ sheath for pacemaker/defibrillator transvenous lead extraction (TLE).Multicenter observational study including patients who underwent a TLE with the TightRail™ sheath in five French university hospitals from September 2014 to January 2020.Two hundred and twenty-five patients (76% males, 71 ± 12 years) underwent a TLE procedure with the TightRail™. A total of 438 leads were extracted using the TightRail™, and the mean age of the extracted leads was 128 ± 85 months; of these, 344 (79%) were pacing leads and 94 (21%) were implantable cardioverter defibrillator leads. The overall clinical success of the extraction procedures was 93%. Overall, 410 of the 438 leads (95%) were extracted (complete or incomplete removal). After multilevel mixed-effects logistic regression model, we found that lead age (odds ratio [OR], 95% confidence interval [CI] for a 1 year increase: 1.11 [1.07-1.15], p .001) and number of leads extracted (OR, 95% CI: 2.09 [1.50-2.96], p .001) were the two independent factors associated with complete lead removal failure. Finally, there were 7 (3%) cases of major complications but no per-procedural death.This is the first large-scale survey assessing the efficacy and safety profile of the Tightrail™ mechanical sheath. The clinical success rate was 93%, and the lead removal failure was dependent on the age and number of leads. We show a satisfactory safety profile in this cohort of patients from primarily low-volume centers with older leads.

Published
2021

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