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1. Rapid ventricular tachycardia in patients with tetralogy of Fallot and implantable cardioverter-defibrillator: Insights from the DAI-T4F nationwide registry

Author

Mikael Laredo, Guillaume Duthoit, Frédéric Sacher, Frédéric Anselme, Caroline Audinet, Francis Bessière, Pierre Bordachar, Abdeslam Bouzeman, Serge Boveda, Sok Sithikun Bun, Morgane Chassignolle, Gaël Clerici, Antoine Da Costa, Maxime de Guillebon, Pascal Defaye, Nathalie Elbaz, Romain Eschalier, Fabrice Extramiana, Laurent Fauchier, Alexis Hermida, Estelle Gandjbakhch, Rodrigue Garcia, Jean-Baptiste Gourraud, Charles Guenancia, Benoit Guy-Moyat, Didier Irles, Laurence Iserin, François Jourda, Linda Koutbi, Fabien Labombarda, Magalie Ladouceur, Philippe Lagrange, Nicolas Lellouche, Jacques Mansourati, Christelle Marquié, Raphael Martins, Grégoire Massoulié, Amel Mathiron, Philippe Maury, Anne Messali, Antoine Milhem, Pierre Mondoly, Cédric Nguyen, Sandro Ninni, Jean Luc Pasquié, Bertrand Pierre, Penelope Pujadas, Jean-Marc Sellal, Jean-Benoit Thambo, Camille Walton, Pierre Winum, Cyril Zakine, Alexandre Zhao, Xavier Jouven, Nicolas Combes, Eloi Marijon, Victor Waldmann, CHU Pitié-Salpêtrière [AP-HP], Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP)-Sorbonne Université (SU), IHU-LIRYC, Université Bordeaux Segalen - Bordeaux 2-CHU Bordeaux [Bordeaux], Institut de rythmologie et modélisation cardiaque [Pessac] (IHU Liryc), Unité de Recherche sur les Maladies Cardiovasculaires, du Métabolisme et de la Nutrition = Research Unit on Cardiovascular and Metabolic Diseases (ICAN), Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP)-Institut National de la Santé et de la Recherche Médicale (INSERM)-Sorbonne Université (SU)-Institut de Cardiométabolisme et Nutrition = Institute of Cardiometabolism and Nutrition [CHU Pitié Salpêtrière] (IHU ICAN), Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP)-Sorbonne Université (SU)-Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP)-Sorbonne Université (SU)-CHU Pitié-Salpêtrière [AP-HP], 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), 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), and Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP)-Hôpitaux Universitaires Paris Ouest - Hôpitaux Universitaires Île de France Ouest (HUPO)

Subjects
Sudden cardiac death, Rapid ventricular tachycardia, [SDV.MHEP.CSC]Life Sciences [q-bio]/Human health and pathology/Cardiology and cardiovascular system, Physiology (medical), Tetralogy of Fallot, Ventricular arrhythmia, Adult congenital heart disease, [SDV.SPEE]Life Sciences [q-bio]/Santé publique et épidémiologie, Cardiology and Cardiovascular Medicine, Implantable cardioverter-defibrillator
Abstract

In repaired tetralogy of Fallot (TOF), little is known about characteristics of patients with rapid ventricular tachycardia (VT). Also, whether patients with a first episode of nonrapid VT may subsequently develop rapid VT or ventricular fibrillation (VF) has not been addressed.The objectives of this study were to compare patients with rapid VT/VF with those with nonrapid VT and to assess the evolution of VT cycle lengths (VTCLs) overtime.Data were analyzed from a nationwide registry including all patients with TOF and implantable cardioverter-defibrillator (ICD) since 2000. Patients with ≥1 VT episode with VTCL ≤250 ms (240 beats/min) formed the rapid VT/VF group.Of 144 patients (mean age 42.0 ± 12.7 years; 104 [72%] men), 61 (42%) had at least 1 VT/VF episode, including 28 patients with rapid VT/VF (46%), during a median follow-up of 6.3 years (interquartile range 2.2-10.3 years). Compared with patients in the nonrapid VT group, those in the rapid VT/VF group were significantly younger at ICD implantation (35.2 ± 12.6 years vs 41.5 ± 11.2 years; P = .04), had more frequently a history of cardiac arrest (8 [29%] vs 2 [6%]; P = .02), less frequently a history of atrial arrhythmia (11 [42%] vs 22 [69%]; P = .004), and higher right ventricular ejection fraction (43.3% ± 10.3% vs 36.6% ± 11.2%; P = .04). The median VTCL of VT/VF episodes was 325 ms (interquartile range 235-429 ms). None of the patients with a first documented nonrapid VT episode had rapid VT/VF during follow-up.Patients with TOF and rapid VT/VF had distinct clinical characteristics. The relatively low variation of VTCL over time suggests a room for catheter ablation without a backup ICD in selected patients with well-tolerated VT.Clinicaltrials.gov identifier: NCT03837574.

Published
2023
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2. Long-Term Follow-Up of Patients With Tetralogy of Fallot and Implantable Cardioverter Defibrillator

Author

Victor Waldmann, Abdeslam Bouzeman, Guillaume Duthoit, Linda Koutbi, Francis Bessiere, Fabien Labombarda, Christelle Marquié, Jean Baptiste Gourraud, Pierre Mondoly, Jean Marc Sellal, Pierre Bordachar, Alexis Hermida, Frédéric Anselme, Anouk Asselin, Caroline Audinet, Yvette Bernard, Serge Boveda, Paul Bru, Sok Sithikun Bun, Gael 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, Raphael Martins, Jean Luc Pasquié, Jean Benoit Thambo, Xavier Jouven, Nicolas Combes, Eloi Marijon, Fabien Squara, Guillaume Theodore, Didier Scarlatti, Jérome Hourdain, Jean-Claude Deharo, Pierre Ollitrault, Paul Milliez, Laure Champ-Rigot, Hugues Bader, Cécile Duplantier, Antoine Milhem, Audrey Sagnard, Géraldine Bertaux, Gabriel Laurent, Marc Badoz, Agustin Bortone, Guillaume Laborie, Anne Rollin, Quentin Voglimacci Stephanopoli, Franck Mandel, Alexandre Duparc, Guillaume Domain, Jean-Paul Albenque, Christèle Cardin, Stéphane Combes, Nikita Tanese, Karim Hasni, Christophe Leclercq, Vincent Galand, Dominique Pavin, Philippe Mabo, Nathalie Behar, Nicolas Clementy, Christophe Loose, Akli Otmani, Sandrine Venier, Adrien Carabelli, Peggy Jacon, Mouna Ben Kilani, Jean Bapstist Guichard, Cécile Romeyer-Bouchard, Laurianne Le Gloan, Vincent Probst, Luc Freysz, Hugues Blangy, Christian De Chillou, Nicolas Sadoul, Pierre Khattar, Charlotte Potelle, Frederic Jean, Paul Puie, Ziad Khoueiry, Philippe Chevallier, Arnaud Dulac, Sylvie Di Filippo, Kevin Gardey, Pierre Frey, Chrystelle Akret, Antoine Dompnier, Carole Maupain, Xavier Waintraub, Françoise Hidden-Lucet, Thomas Chastre, Estelle Gandjbakhch, Nicolas Badenco, Fabrice Extramiana, Antoine Leenhardt, Amir Zouaghi, Vincent Algalarrondo, Denis Amet, Emilie Varlet, Tej Chalbia, Séverine Philibert, Jacky Ollitrault, Thomas Lavergne, Pierre Baudinaud, Adrian Mirolo, Arnaud Savouré, Bénédicte Godin, Cathy Bertrand, Pierre Fiorello, Nicolas Johnson, Pierre-Marc Lallemand, Alexis Herminda, Jean-Sylvain Hermida, Bruno Degand, Rim El Bouazzaou, Stéphane Mourot, Samuel Goussot, Gaël Jauvert, Arnaud Lazarus, Caroline Grimard, Christine Alonso, Alexandre Zhao, Olivier Thomas, Bruno Cauchemez, Ghassan Moubarak, Nicolas Lellouche, David Hamon, Bogdan Enache, Gabriel Lactu, Françoise Wiart, Olivier Geoffroy, Damien Poindron, Alice Maltret, Cristine Raimondo, Damien Bonnet, Sébastien Hascoët, Nicolas Derval, Michel Haïssaguerre, Mélèze Hocini, and Clinical sciences

Subjects
Adult, Male, medicine.medical_specialty, Long term follow up, Cyanotic congenital heart disease, medicine.medical_treatment, 030204 cardiovascular system & hematology, Sudden death, Sudden cardiac death, 03 medical and health sciences, 0302 clinical medicine, Physiology (medical), Internal medicine, medicine, Humans, Defibrillators, Implantable/trends, Registries, 030212 general & internal medicine, Tetralogy of Fallot, business.industry, medicine.disease, Implantable cardioverter-defibrillator, Tetralogy of Fallot/epidemiology, Defibrillators, Implantable, 3. Good health, Cardiology, Female, Cardiology and Cardiovascular Medicine, business, Follow-Up Studies
Abstract

Background: Tetralogy of Fallot (TOF) is the most common cyanotic congenital heart disease, and sudden cardiac death represents an important mode of death in these patients. Data evaluating the implantable cardioverter defibrillator (ICD) in this patient population remain scarce. Methods: A Nationwide French Registry including all patients with tetralogy of Fallot with an ICD was initiated in 2010 by the French Institute of Health and Medical Research. The primary time to event end point was the time from ICD implantation to first appropriate ICD therapy. Secondary outcomes included ICD-related complications, heart transplantation, and death. Clinical events were centrally adjudicated by a blinded committee. Results: A total of 165 patients (mean age, 42.2±13.3 years, 70.1% males) were included from 40 centers, including 104 (63.0%) in secondary prevention. During a median (interquartile range) follow-up of 6.8 (2.5–11.4) years, 78 (47.3%) patients received at least 1 appropriate ICD therapy. The annual incidence of the primary outcome was 10.5% (7.1% and 12.5% in primary and secondary prevention, respectively; P =0.03). Overall, 71 (43.0%) patients presented with at least 1 ICD complication, including inappropriate shocks in 42 (25.5%) patients and lead dysfunction in 36 (21.8%) patients. Among 61 (37.0%) patients in primary prevention, the annual rate of appropriate ICD therapies was 4.1%, 5.3%, 9.5%, and 13.3% in patients with, respectively, 0, 1, 2, or ≥3 guidelines-recommended risk factors. QRS fragmentation was the only independent predictor of appropriate ICD therapies (hazard ratio, 3.47 [95% CI, 1.19–10.11]), and its integration in a model with current criteria increased the 5-year time-dependent area under the curve from 0.68 to 0.81 ( P =0.006). Patients with congestive heart failure or reduced left ventricular ejection fraction had a higher risk of nonarrhythmic death or heart transplantation (hazard ratio, 11.01 [95% CI, 2.96–40.95]). Conclusions: Patients with tetralogy of Fallot and an ICD experience high rates of appropriate therapies, including those implanted in primary prevention. The considerable long-term burden of ICD-related complications, however, underlines the need for careful candidate selection. A combination of easy-to-use criteria including QRS fragmentation might improve risk stratification. Registration: URL: https://www.clinicaltrials.gov ; Unique identifier: NCT03837574.

Published
2020
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3. 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
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4. Impact of Pulmonary Valve Replacement on Ventricular Arrhythmias in Patients With Tetralogy of Fallot and Implantable Cardioverter-Defibrillator

Author

Cédric Nguyen, François Jourda, Alexis Hermida, Pascal Defaye, Frederic Sacher, Yvette Bernard, Serge Boveda, Marie-Cécile Perier, Philippe Chevalier, Pierre Winum, Mikael Laredo, Abdeslam Bouzeman, C. Marquie, Raphaël P. Martins, Jean Benoit Thambo, Laurence Iserin, Maxime De Guillebon, Kévin Gardey, Antoine Da Costa, Pierre Bordachar, Benoit Guy-Moyat, Anouk Asselin, Jean Marc Sellal, Francis Bessière, Linda Koutbi, Pierre Mondoly, Victor Waldmann, Grégoire Massoulié, Jacques Mansourati, Roland Henaine, Romain Eschalier, Fabien Labombarda, Sandro Ninni, Charles Guenancia, Sylvie Di Filippo, Philippe Maury, Rodrigue Garcia, Bertrand Pierre, Magalie Ladouceur, Caroline Audinet, Amel Mathiron, Camille Walton, Philippe Lagrange, Guillaume Duthoit, Xavier Jouven, Didier Irles, Nicolas Combes, Jean Luc Pasquié, G Clerici, Frédéric Anselme, Jean-Baptiste Gourraud, Eloi Marijon, Hôpital Louis Pradel [CHU - HCL], Hospices Civils de Lyon (HCL), CHU Pitié-Salpêtrière [AP-HP], Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP)-Sorbonne Université (SU), Hôpital de la Timone [CHU - APHM] (TIMONE), CHU Caen, Normandie Université (NU)-Tumorothèque de Caen Basse-Normandie (TCBN), Centre Hospitalier Régional Universitaire [Lille] (CHRU Lille), Centre hospitalier universitaire de Nantes (CHU Nantes), CHU Toulouse [Toulouse], Imagerie Adaptative Diagnostique et Interventionnelle (IADI), Institut National de la Santé et de la Recherche Médicale (INSERM)-Université de Lorraine (UL), Centre Hospitalier Régional Universitaire de Nancy (CHRU Nancy), CHU Bordeaux [Bordeaux], CHU Amiens-Picardie, CHU Rouen, Normandie Université (NU), 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 de Paris (UP), Groupe Hospitalier Bretagne Sud (GHBS), Centre Hospitalier Régional Universitaire de Besançon (CHRU Besançon), Clinique Pasteur [Toulouse], CHU Sud Saint Pierre [Ile de la Réunion], Centre Hospitalier Universitaire de Saint-Etienne (CHU de Saint-Etienne), Centre hospitalier de Pau, Centre Hospitalier Universitaire [Grenoble] (CHU), CHU Clermont-Ferrand, Centre hospitalier universitaire de Poitiers (CHU Poitiers), CHU Dijon, Centre Hospitalier Universitaire de Dijon - Hôpital François Mitterrand (CHU Dijon), CHU Limoges, Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP)-Hôpitaux Universitaires Paris Ouest - Hôpitaux Universitaires Île de France Ouest (HUPO), Centre Hospitalier Régional Universitaire de Brest (CHRU Brest), Centre Hospitalier Chalon-sur-Saône William Morey, Centre Hospitalier Régional Universitaire de Tours (CHRU TOURS), Centre Hospitalier Universitaire de Nîmes (CHU Nîmes), Physiologie & médecine expérimentale du Cœur et des Muscles [U 1046] (PhyMedExp), Université de Montpellier (UM)-Institut National de la Santé et de la Recherche Médicale (INSERM)-Centre National de la Recherche Scientifique (CNRS), Centre Hospitalier Régional Universitaire [Montpellier] (CHRU Montpellier), Centre National de la Recherche Scientifique (CNRS)-Institut National de la Santé et de la Recherche Médicale (INSERM)-Université de Montpellier (UM), Clinical sciences, Centre Hospitalier Universitaire de Toulouse (CHU Toulouse), 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), Centre Hospitalier Régional Universitaire de Tours (CHRU Tours), Institut National de la Santé et de la Recherche Médicale (INSERM)-Université de Montpellier (UM)-Centre National de la Recherche Scientifique (CNRS), SELLAL, Jean-Marc, and Sorbonne Université (SU)-Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP)

Subjects
Adult, Male, medicine.medical_specialty, medicine.medical_treatment, [SDV]Life Sciences [q-bio], Population, 030204 cardiovascular system & hematology, Sudden death, Sudden cardiac death, 03 medical and health sciences, 0302 clinical medicine, [SDV.MHEP.CSC]Life Sciences [q-bio]/Human health and pathology/Cardiology and cardiovascular system, Interquartile range, Internal medicine, medicine, Humans, Implantable cardioverter defibrilator, 030212 general & internal medicine, Cardiac Surgical Procedures, education, Pulmonary Valve/surgery, ComputingMilieux_MISCELLANEOUS, Tetralogy of Fallot, Cause of death, Pulmonary Valve, education.field_of_study, [SDV.MHEP] Life Sciences [q-bio]/Human health and pathology, business.industry, Ventriculat arrhythmia, Arrhythmias, Cardiac, Middle Aged, medicine.disease, Implantable cardioverter-defibrillator, eye diseases, [SDV.MHEP.CSC] Life Sciences [q-bio]/Human health and pathology/Cardiology and cardiovascular system, Defibrillators, Implantable, 3. Good health, Tetralogy of Fallot/surgery, Arrhythmias, Cardiac/therapy, Pulmonary valve replacement, Cohort, Cardiology, Female, Cardiology and Cardiovascular Medicine, business, [SDV.MHEP]Life Sciences [q-bio]/Human health and pathology
Abstract

International audience; Objectives: This study aimed to assess the impact of pulmonary valve replacement (PVR) on ventricular arrhythmias burden in a population of tetralogy of Fallot (TOF) patients with continuous cardiac monitoring by implantable cardioverter-defibrillators (ICDs).Background: Sudden cardiac death is a major cause of death in TOF, and right ventricular overload is commonly considered to be a potential trigger for ventricular arrhythmias.Methods: Data were analyzed from a nationwide French ongoing study (DAI-T4F) including all TOF patients with an ICD since 2000. Survival data with recurrent events were used to compare the burden of appropriate ICD therapies before and after PVR in patients who underwent PVR over the study period.Results: A total of 165 patients (mean age 42.2 ± 13.3 years, 70.1% male) were included from 40 centers. Over a median follow-up period of 6.8 (interquartile range: 2.5 to 11.4) years, 26 patients (15.8%) underwent PVR. Among those patients, 18 (69.2%) experienced at least 1 appropriate ICD therapy. When considering all ICD therapies delivered before (n = 62) and after (n = 16) PVR, the burden of appropriate ICD therapies was significantly lower after PVR (HR: 0.21; 95% confidence interval [CI]: 0.08 to 0.56; p = 0.002). Respective appropriate ICD therapies rates per 100 person-years were 44.0 (95% CI: 35.7 to 52.5) before and 13.2 (95% CI: 7.7 to 20.5) after PVR (p < 0.001). In the overall cohort, PVR before ICD implantation was also independently associated with a lower risk of appropriate ICD therapy in primary prevention patients (HR: 0.29 [95% CI: 0.10 to 0.89]; p = 0.031).Conclusions: In this cohort of high-risk TOF patients implanted with an ICD, the burden of appropriate ICD therapies was significantly reduced after PVR. While optimal indications and timing for PVR are debated, these findings suggest the importance of considering ventricular arrhythmias in the overall decision-making process. (French National Registry of Patients With Tetralogy of Fallot and Implantable Cardioverter Defibrillator [DAI-T4F]; NCT03837574).

Published
2021
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5. Long-term follow-up of patients with tetralogy of fallot and implantable cardioverter defibrillator–The DAI-T4F nationwide registry

Author

Guillaume Duthoit, Mikael Laredo, Antoine Da Costa, Romain Eschalier, Fabien Labombarda, Laurent Fauchier, Benoit Guy-Moyat, Laurence Iserin, Pierre Winum, Marie-Cécile Perier, Philippe Maury, Nicolas Combes, Victor Waldmann, Didier Irles, Philippe Lagrange, Magalie Ladouceur, Jean-Benoit Thambo, Bertrand Pierre, Eloi Marijon, Jean-Marc Sellal, Grégoire Massoulié, Maxime De Guillebon, Ardalan Sharifzadehgan, Jacques Mansourati, Sandro Ninni, Penelope Pujadas, Linda Koutbi, Anouk Asselin, Pascal Sagnol, Nathalie Elbaz, Rodrigue Garcia, Dai-T F investigators, Caroline Audinet, G Clerici, Kumar Narayanan, Amel Mathiron, Xavier Jouven, Frédéric Anselme, Camille Walton, Anne Messali, Jean-Baptiste Gourraud, Yvette Bernard, Charles Guenancia, Alexis Hermida, Raphaël P. Martins, Pierre Bordachar, Cyril Zakine, Francis Bessière, Pierre Mondoly, Franck Halimi, Paul Bru, C. Marquie, François Jourda, Pascal Defaye, Frederic Sacher, Sok Sithikun Bun, Jean-Luc Pasquié, Cédric Nguyen, and Abdeslam Bouzeman

Subjects
medicine.medical_specialty, Long term follow up, business.industry, medicine.medical_treatment, Area under the curve, Qrs fragmentation, Implantable cardioverter-defibrillator, medicine.disease, Sudden cardiac death, Internal medicine, medicine, In patient, Cardiology and Cardiovascular Medicine, Complication, business, Tetralogy of Fallot
Abstract

Introduction Tetralogy of Fallot (TOF) is the most common cyanotic congenital heart disease, and sudden cardiac death represents an important mode of death in these patients. Data evaluating the implantable cardioverter defibrillator (ICD) in this patient population remain scarce. Objective We aimed to describe long-term follow-up of TOF patients implanted with ICD through a nationwide French registry. Methods Nationwide French Registry including all TOF patients with an ICD initiated in 2010 by the French Institute of Health and Medical Research. The primary time to event endpoint was the time from ICD implantation to first appropriate ICD therapy. Clinical events were centrally adjudicated by a blinded committee. Results A total of 165 patients (mean age 42.2 ± 13.3 years, 70.1% males) were included from 40 centers, including 104 (63.0%) in secondary prevention. During a median (IQR) follow-up of 6.8 (2.5–11.4) years, 78 (47.3%) patients received at least one appropriate ICD therapy. The annual incidence of the primary outcome was 10.5% (7.1% and 12.5% in primary and secondary prevention, respectively, P = 0.03). Overall, 71 (43.0%) patients presented with at least one ICD complication, including inappropriate shocks in 42 (25.5%) patients and lead dysfunction in 36 (21.8%) patients. Among 61 (37.0%) primary prevention patients, the annual rate of appropriate ICD therapies was 4.1%, 5.3%, 9.5%, and 13.3% in patients with respectively no, one, two, or ≥ three guideline-recommended risk factors. QRS fragmentation was the only independent predictor of appropriate ICD therapies (HR 3.47, 95% CI 1.19–10.11), and its integration in a model with current criteria increased the 5-year time-dependent area under the curve from 0.68 to 0.81 (P = 0.006) ( Fig. 1 ). Conclusions Patients with TOF and an ICD experience high rates of appropriate therapies, including those implanted in primary prevention. The considerable long-term burden of ICD-related complications, however, underlines the need for careful candidate selection. A combination of easy-to-use criteria including QRS fragmentation might improve risk stratification.

Published
2021
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6. 5204Primary prevention of sudden cardiac death in patients with tetralogy of Fallot with implantable cardioverter defibrillator: insights from the DAI-T4F study

Author

Caroline Audinet, A. Bouzeman, Charles Guenancia, Pascal Defaye, Nicolas Combes, Magalie Ladouceur, Amel Mathiron, Jean-Luc Pasquié, C. Marquie, Jean-Benoit Thambo, Victor Waldmann, Francis Bessière, Eloi Marijon, Laurence Iserin, and Fabien Labombarda

Subjects
medicine.medical_specialty, business.industry, medicine.medical_treatment, Internal medicine, medicine, Cardiology, In patient, Cardiology and Cardiovascular Medicine, Implantable cardioverter-defibrillator, medicine.disease, business, Sudden cardiac death, Tetralogy of Fallot
Abstract

Background Ventricular arrhythmias and sudden death are feared late complications in patients with tetralogy of Fallot. Selection of candidates for primary prevention implantable cardioverter defibrillator (ICD) remains challenging in this population. Non-sustained ventricular tachycardia (NSVT), altered left ventricular ejection fraction (LVEF), positive programmed ventricular stimulation, and enlarged QRS are currently used for risk stratification. Purpose To identify high-risk patients with tetralogy of Fallot in the setting of primary prevention of sudden cardiac death. Methods The DAI-T4F study is a large ongoing national French registry including all patients with tetralogy of Fallot and ICD (NCT03837574). Information have been collected prospectively since 2010 with annual update. Baseline patient characteristics and clinical events during the follow-up were analyzed with central adjudication. Cox proportional hazard models were used to identify factors associated with appropriate ICD therapies. Results Among 134 patients enrolled, 47 (35.1%) underwent ICD implantation for primary prevention (median age 49.1 years, 76.6% males). At baseline, 20 (42.6%) patients had NSVT, 17 (36.2%) had severe altered LVEF ≤35%, 16 (34.0%) had positive programmed ventricular stimulation, and 16 (34.0%) had QRS duration ≥180ms. Overall, 20 (42.6%), 15 (31.9%), and 6 (12.8%) patients had respectively one, two, or ≥ three of these risk factors. Six (12.8%) patients were implanted for other indications. During a median (IQR) follow-up duration of 5.3 (2.1–8.0) years, 14 (29.8%) patients had at least one appropriate ICD therapy. The annual incidence of appropriate ICD therapies were 2.8%, 4.6%, 6.3%, and 8.6% in patients with none, one, two, or ≥ three of these factors (p for trend = 0.145). None of predictors, considered isolated, was significantly associated with ICD appropriate therapies. Patients with non-sustained ventricular tachycardia (NSVT) and positive programmed ventricular stimulation had a significant increased risk of ICD appropriate therapies (HR=3.8, 95% CI: 1.1–14.3, p=0.035), as well as patients with NSVT and QRSd ≥180 ms (HR=7.2, 95% CI: 1.6–32.7, p=0.003). No patient with severe altered LVEF without other risk factor had appropriate ICD therapy. Patients with congestive heart failure and/or altered LVEF had a higher risk of non-sudden death or cardiac transplantation (HR=14.4, 95% CI: 1.8–112.7, p Conclusions Our data illustrate that specific risk stratification and primary prevention for sudden cardiac death in patients with tetralogy of Fallot may be improved. The value of a severely altered LVEF appears low in the absence of other risk factors, and combination of different predictors is essential. The high rate of complications as well as consideration of competing risk situation have to be integrated in the benefit-risk equation.

Published
2019
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7. Primary prevention of sudden cardiac death in patients with tetralogy of Fallot with implantable cardioverter defibrillator: Insights from the DAI-T4F study

Author

Eloi Marijon, Laurence Iserin, Magalie Ladouceur, Fabien Labombarda, Francis Bessière, Amel Mathiron, Yvette Bernard, Victor Waldmann, C. Marquie, Pierre Winum, Jean-Luc Pasquié, Charles Guenancia, Camille Walton, Nicolas Combes, Benoit Guy-Moyat, Caroline Audinet, J.B. Thambo, Paul Bru, Pascal Defaye, and A. Bouzeman

Subjects
medicine.medical_specialty, Ejection fraction, business.industry, medicine.medical_treatment, medicine.disease, Implantable cardioverter-defibrillator, Ventricular tachycardia, Sudden death, Sudden cardiac death, QRS complex, Internal medicine, cardiovascular system, Cardiology, Medicine, In patient, Cardiology and Cardiovascular Medicine, business, Tetralogy of Fallot
Abstract

Background Ventricular arrhythmias and sudden death are feared late complications in patients with tetralogy of Fallot. Selection of candidates for primary prevention implantable cardioverter defibrillator (ICD) remains challenging. Purpose To identify patients with tetralogy of Fallot at high-risk of sudden cardiac death in primary prevention. Methods The DAI-T4F study is an ongoing national French registry including all patients with tetralogy of Fallot and ICD ( NCT03837574 ). Information have been collected prospectively since 2010. Cox proportional hazard models were used to identify factors associated with appropriate ICD therapies. Results Among 134 patients enrolled, 47 (35.1%) underwent ICD implantation for primary prevention (median age 49.1 years, 76.6% males). At baseline, 20 (42.6%) patients had NSVT, 17 (36.2%) had altered LVEF ≤ 35%, 16 (34.0%) had positive programmed ventricular stimulation, and 16 (34.0%) had QRS duration ≥ 180ms. During a median (IQR) follow-up duration of 5.3 (2.1–8.0) years, 14 (29.8%) patients had at least one appropriate ICD therapy. The annual incidence of appropriate ICD therapies were 2.8%, 4.6%, 6.3%, and 8.6% in patients with none, one, two, or ≥ three of these factors (P for trend = 0.145). None of predictors, considered isolated, was significantly associated with ICD appropriate therapies. Patients with non-sustained ventricular tachycardia (NSVT) and positive programmed ventricular stimulation had a significant increased risk of ICD appropriate therapies (HR = 3.8, 95% CI: 1.1–14.3, P = 0.035), as well as patients with NSVT and QRSd ≥ 180 ms (HR = 7.2, 95% CI: 1.6–32.7, P = 0.003). No patient with severe altered LVEF without other risk factor had appropriate ICD therapy. Conclusions Our data illustrate that specific risk stratification and primary prevention for sudden cardiac death in patients with tetralogy of Fallot may be improved. The value of a severely altered LVEF appears low in the absence of other risk factors.

Published
2020
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8. Clinical contributions of 64-slice computed tomography in the evaluation of cardiomyopathy of unknown origin

Author

Hervé Le Breton, Caroline Audinet, David Veillard, A. Larralde, Marc Bedossa, Dominique Boulmier, Stéphanie Hamonic, Mireille Garreau, Guillaume Leurent, Jean-François Heautot, Laboratoire Traitement du Signal et de l'Image (LTSI), Université de Rennes 1 (UR1), Université de Rennes (UNIV-RENNES)-Université de Rennes (UNIV-RENNES)-Institut National de la Santé et de la Recherche Médicale (INSERM), Service de cardiologie et maladies vasculaires [Rennes] = Cardiac, Thoracic, and Vascular Surgery [Rennes], CHU Pontchaillou [Rennes], Service de radiologie et imagerie médicale [Rennes] = Radiology [Rennes], CIC-IT Rennes, Hôpital Pontchaillou-Institut National de la Santé et de la Recherche Médicale (INSERM), This work was supported by our local research committee (Comité de Recherche Clinique du CHU de Rennes [COREC])., and Université de Rennes (UR)-Institut National de la Santé et de la Recherche Médicale (INSERM)

Subjects
Male, Cardiomyopathy, 030204 cardiovascular system & hematology, Coronary Angiography, MESH: Stroke Volume, Severity of Illness Index, MESH: Ventricular Function, Left, Ventricular Function, Left, 030218 nuclear medicine & medical imaging, Coronary artery disease, Ventricular Dysfunction, Left, 0302 clinical medicine, [INFO.INFO-TS]Computer Science [cs]/Signal and Image Processing, MESH: Ventricular Dysfunction, Left, Sinus rhythm, Prospective Studies, Cardiac imaging, MESH: Aged, Coronary disease, Ejection fraction, MESH: Middle Aged, medicine.diagnostic_test, Coronary Sinus, General Medicine, Middle Aged, MESH: Predictive Value of Tests, 3. Good health, medicine.anatomical_structure, MESH: Young Adult, Echocardiography, Cardiology, [SDV.IB]Life Sciences [q-bio]/Bioengineering, Female, Cardiology and Cardiovascular Medicine, MESH: Tomography, X-Ray Computed, Cardiomyopathies, [SPI.SIGNAL]Engineering Sciences [physics]/Signal and Image processing, MESH: Coronary Sinus, Adult, medicine.medical_specialty, Heart Ventricles, Sensitivity and Specificity, 03 medical and health sciences, Young Adult, MESH: Coronary Stenosis, [SDV.MHEP.CSC]Life Sciences [q-bio]/Human health and pathology/Cardiology and cardiovascular system, Predictive Value of Tests, Internal medicine, MESH: Severity of Illness Index, medicine, Humans, Vein, Idiopathic Cardiomyopathy, Cardiomyopathie, Aged, MESH: Humans, Imagerie cardiaque non invasive, business.industry, Coronary Stenosis, MESH: Adult, Stroke Volume, medicine.disease, MESH: Male, MESH: Prospective Studies, MESH: Sensitivity and Specificity, MESH: Coronary Angiography, Maladie coronaire, MESH: Cardiomyopathies, Angiography, MESH: Echocardiography, MESH: Heart Ventricles, business, Tomography, X-Ray Computed, MESH: Female
Abstract

Summary Background Meta-analyses have confirmed the high performance of multislice computed tomography (MSCT) in coronary stenosis detection. Recent reports have described the study of left ventricular anatomy and function and coronary venous anatomy with MSCT. Aims We sought to compare, in patients with cardiomyopathy of unknown origin, the performance of MSCT versus angiography for significant coronary artery disease detection and versus transthoracic echocardiography (TTE) for left ventricular anatomy and function evaluation, and to assess its ability to characterize coronary venous anatomy. Methods Fifty-nine patients with cardiomyopathy (left ventricular ejection fraction [LVEF] less than or equal to 40%) of unknown origin, in sinus rhythm, underwent MSCT, TTE and coronary angiography. Results Twenty-four (3%) of 724 analysable coronary segments (97%) and 12 (20%) patients had significant coronary artery disease. MSCT sensitivity, specificity, and positive and negative predictive values for coronary artery disease detection were 87.5%, 98.5%, 67.7% and 99.6% in the per-segment assessment and 100%, 91%, 75% and 100% in the per-patient evaluation, respectively. Statistical analyses showed good agreement between MSCT and TTE in LVEF measurement (33 ± 10% vs 32 ± 11%, p = 0.4, mean difference = 0.7%, limits of agreement ± 13.6%) and a small LVED diameter overestimation (65.0 ± 9.3 mm vs 63.6 ± 9.4 mm, p = 0.03). MSCT allowed detection of the posterolateral vein in 86% of cases. Conclusions In selected patients presenting with idiopathic cardiomyopathy, MSCT is accurate for coronary artery disease detection and is a useful coronary venous imaging tool. MSCT studies of left ventricular function and morphology were mostly concordant with TTE measurements.

Published
2009
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