Subcutaneous Implantable Cardioverter-Defibrillators in Patients With Congenital Heart Disease.


Journal

Journal of the American College of Cardiology
ISSN: 1558-3597
Titre abrégé: J Am Coll Cardiol
Pays: United States
ID NLM: 8301365

Informations de publication

Date de publication:
15 08 2023
Historique:
received: 11 04 2023
revised: 12 05 2023
accepted: 15 05 2023
medline: 11 8 2023
pubmed: 10 8 2023
entrez: 9 8 2023
Statut: ppublish

Résumé

Very few data have been published on the use of subcutaneous implantable cardioverter-defibrillators (S-ICDs) in patients with congenital heart disease (CHD). The aim of this study was to analyze outcomes associated with S-ICDs in patients with CHD. This nationwide French cohort including all patients with an S-ICD was initiated in 2020 by the French Institute of Health and Medical Research. Characteristics at implantation and outcomes were analyzed in patients with CHD. From October 12, 2012, to December 31, 2019, among 4,924 patients receiving an S-ICD implant in 150 centers, 101 (2.1%) had CHD. Tetralogy of Fallot, univentricular heart, and dextro-transposition of the great arteries represented almost one-half of the population. Patients with CHD were significantly younger (age 37.1 ± 15.4 years vs 50.1 ± 14.9 years; P < 0.001), more frequently female (37.6% vs 23.0%; P < 0.001), more likely to receive an S-ICD for secondary prevention (72.3% vs 35.9%; P < 0.001), and less likely to have severe systolic dysfunction of the systemic ventricle (28.1% vs 53.1%; P < 0.001). Over a mean follow-up period of 1.9 years, 16 (15.8%) patients with CHD received at least 1 appropriate shock, with all shocks successfully terminating the ventricular arrhythmia. The crude risk of appropriate S-ICD shock was twice as high in patients with CHD compared with non-CHD patients (annual incidences of 9.0% vs 4.4%; HR: 2.1; 95% CI: 1.3-3.4); however, this association was no longer significant after propensity matching (especially considering S-ICD indication, P = 0.12). The burden of all complications (HR: 1.2; 95% CI: 0.7-2.1; P = 0.4) and inappropriate shocks (HR: 0.9; 95% CI: 0.4-2.0; P = 0.9) was comparable in both groups. In this nationwide study, patients with CHD represented 2% of all S-ICD implantations. Our findings emphasize the effectiveness and safety of S-ICD in this particularly high-risk population. (S-ICD French Cohort Study [HONEST]; NCT05302115).

Sections du résumé

BACKGROUND
Very few data have been published on the use of subcutaneous implantable cardioverter-defibrillators (S-ICDs) in patients with congenital heart disease (CHD).
OBJECTIVES
The aim of this study was to analyze outcomes associated with S-ICDs in patients with CHD.
METHODS
This nationwide French cohort including all patients with an S-ICD was initiated in 2020 by the French Institute of Health and Medical Research. Characteristics at implantation and outcomes were analyzed in patients with CHD.
RESULTS
From October 12, 2012, to December 31, 2019, among 4,924 patients receiving an S-ICD implant in 150 centers, 101 (2.1%) had CHD. Tetralogy of Fallot, univentricular heart, and dextro-transposition of the great arteries represented almost one-half of the population. Patients with CHD were significantly younger (age 37.1 ± 15.4 years vs 50.1 ± 14.9 years; P < 0.001), more frequently female (37.6% vs 23.0%; P < 0.001), more likely to receive an S-ICD for secondary prevention (72.3% vs 35.9%; P < 0.001), and less likely to have severe systolic dysfunction of the systemic ventricle (28.1% vs 53.1%; P < 0.001). Over a mean follow-up period of 1.9 years, 16 (15.8%) patients with CHD received at least 1 appropriate shock, with all shocks successfully terminating the ventricular arrhythmia. The crude risk of appropriate S-ICD shock was twice as high in patients with CHD compared with non-CHD patients (annual incidences of 9.0% vs 4.4%; HR: 2.1; 95% CI: 1.3-3.4); however, this association was no longer significant after propensity matching (especially considering S-ICD indication, P = 0.12). The burden of all complications (HR: 1.2; 95% CI: 0.7-2.1; P = 0.4) and inappropriate shocks (HR: 0.9; 95% CI: 0.4-2.0; P = 0.9) was comparable in both groups.
CONCLUSIONS
In this nationwide study, patients with CHD represented 2% of all S-ICD implantations. Our findings emphasize the effectiveness and safety of S-ICD in this particularly high-risk population. (S-ICD French Cohort Study [HONEST]; NCT05302115).

Identifiants

pubmed: 37558371
pii: S0735-1097(23)05965-X
doi: 10.1016/j.jacc.2023.05.057
pii:
doi:

Banques de données

ClinicalTrials.gov
['NCT05302115']

Types de publication

Journal Article Research Support, Non-U.S. Gov't

Langues

eng

Sous-ensembles de citation

IM

Pagination

590-599

Commentaires et corrections

Type : CommentIn

Informations de copyright

Copyright © 2023 American College of Cardiology Foundation. Published by Elsevier Inc. All rights reserved.

Déclaration de conflit d'intérêts

Funding Support and Author Disclosures This study was supported by the French Institute of Health and Medical Research and Paris-Sudden Death Expertise Center, the French Society of Cardiology (Electrophysiology Working Group), and the French Federation of Cardiology. The Paris Sudden Death Expertise Center activities are supported by the Institut National de la Santé et de la Recherche Médicale (INSERM), the University of Paris, Assistance Publique-Hôpitaux de Paris, Fondation Cœur et Artères, Global Heart Watch, Fédération Française de Cardiologie, Société Française de Cardiologie, and Fondation Recherche Medicale, as well as unrestricted grants from industrial partners (Abbott, Biotronik, Boston Scientific, Medtronic, MicroPort, ZOLL, and Schiller). Dr Waldmann has served as a consultant for Abbott and Medtronic. Dr Marijon has served as a consultant for Boston Scientific, Medtronic, ZOLL, and Abbott. Dr Ollitrault has received consulting fees from Abbott, Biotronik, Boston Scientific, and Medtronic. Dr Champ-Rigot has received consulting fees from Boston Scientific, Medtronic, and MicroPort CRM. Dr Garcia has received grants and honoraria from Boston Scientific. All other authors have reported that they have no relationships relevant to the contents of this paper to disclose.

Auteurs

Victor Waldmann (V)

Université de Paris, INSERM, Paris Cardiovascular Research Centre, Paris, France; Adult Congenital Heart Disease Medico-Surgical Unit, European Georges Pompidou Hospital, Paris, France; Pediatric and Congenital Medico-Surgical Unit, Necker Hospital, Paris, France; Cardiac Electrophysiology Unit, European Georges Pompidou Hospital, Paris, France. Electronic address: victor.waldmann@gmail.com.

Christelle Marquié (C)

CHU de Lille, Lille, France.

Francis Bessière (F)

Université de Lyon, INSERM LabTau, Lyon, France; Hôpital Louis Pradel, Hospices Civils de Lyon, Lyon, France.

David Perrot (D)

Université de Paris, INSERM, Paris Cardiovascular Research Centre, Paris, France; Cardiac Electrophysiology Unit, European Georges Pompidou Hospital, Paris, France.

Frédéric Anselme (F)

CHU de Rouen, Rouen, France.

Nicolas Badenco (N)

Hôpital La Pitié Salpêtrière, Paris, France.

Sergio Barra (S)

Université de Paris, INSERM, Paris Cardiovascular Research Centre, Paris, France; Cardiology Department, Hospital da Luz Arrábida, Vila Nova de Gaia, Portugal.

Géraldine Bertaux (G)

CHU Dijon Bourgogne, Dijon, France.

Hugues Blangy (H)

CHU Nancy, Nancy, France.

Pierre Bordachar (P)

CHU de Bordeaux, Bordeaux, France.

Serge Boveda (S)

Clinique Pasteur, Toulouse, France.

Michel Chauvin (M)

ICS HENA Strasbourg, Strasbourg, France; Clinique de l'Orangerie, Strasbourg, France.

Nicolas Clémenty (N)

CHU de Tours, Tours, France.

Gaël Clerici (G)

CHU de la Réunion, Saint-Pierre, France.

Nicolas Combes (N)

Clinique Pasteur, Toulouse, France.

Pascal Defaye (P)

CHU Grenoble Alpes, Grenoble, France.

Jean-Claude Deharo (JC)

Assistance Publique-Hôpitaux de Marseille, Centre Hospitalier Universitaire La Timone, Service de Cardiologie, Marseille, France and Aix Marseille Université, C2VN, Marseille, France.

Philippe Durand (P)

Centre Médico-Chirurgical Arnault Tzanck, St Laurent du Var, France.

Guillaume Duthoit (G)

Hôpital La Pitié Salpêtrière, Paris, France.

Romain Eschalier (R)

Cardiology Department, CHU Clermont-Ferrand, F-63000 Clermont-Ferrand, France, and Université Clermont Auvergne, CHU Clermont-Ferrand, CNRS, SIGMA Clermont, Institut Pascal, F-63000 Clermont-Ferrand, France.

Laurent Fauchier (L)

CHU de Tours, Tours, France.

Rodrigue Garcia (R)

Cardiology Department, University Hospital of Poitiers, Poitiers, France; Centre d'Investigations Cliniques 1402, University Hospital of Poitiers, Poitiers, France.

Olivier Geoffroy (O)

CHU de la Réunion, Saint-Pierre, France.

Edouard Gitenay (E)

Hôpital Saint Joseph, Marseille, France.

Jean-Baptiste Gourraud (JB)

CHU de Nantes, Nantes, France.

Charles Guenancia (C)

CHU Dijon Bourgogne, Dijon, France.

Laurence Iserin (L)

Adult Congenital Heart Disease Medico-Surgical Unit, European Georges Pompidou Hospital, Paris, France.

Peggy Jacon (P)

CHU Grenoble Alpes, Grenoble, France.

Laurence Jesel-Morel (L)

CHU de Strasbourg, Strasbourg, France.

Fawzi Kerkouri (F)

Université de Paris, INSERM, Paris Cardiovascular Research Centre, Paris, France; University Hospital of Brest, Brest, France.

Didier Klug (D)

CHU de Lille, Lille, France.

Linda Koutbi (L)

Assistance Publique-Hôpitaux de Marseille, Centre Hospitalier Universitaire La Timone, Service de Cardiologie, Marseille, France and Aix Marseille Université, C2VN, Marseille, France.

Fabien Labombarda (F)

CHU de Caen, Caen, France.

Magalie Ladouceur (M)

Université de Paris, INSERM, Paris Cardiovascular Research Centre, Paris, France; Adult Congenital Heart Disease Medico-Surgical Unit, European Georges Pompidou Hospital, Paris, France.

Gabriel Laurent (G)

CHU Dijon Bourgogne, Dijon, France.

Christophe Leclercq (C)

CHRU Rennes, Rennes, France.

Baptiste Maille (B)

Assistance Publique-Hôpitaux de Marseille, Centre Hospitalier Universitaire La Timone, Service de Cardiologie, Marseille, France and Aix Marseille Université, C2VN, Marseille, France.

Alice Maltret (A)

Hôpital Marie Lannelongue, Le Plessis Robinson, France.

Grégoire Massoulié (G)

Cardiology Department, CHU Clermont-Ferrand, F-63000 Clermont-Ferrand, France, and Université Clermont Auvergne, CHU Clermont-Ferrand, CNRS, SIGMA Clermont, Institut Pascal, F-63000 Clermont-Ferrand, France.

Pierre Mondoly (P)

CHU de Toulouse, Toulouse, France.

Sandro Ninni (S)

CHU de Lille, Lille, France.

Pierre Ollitrault (P)

CHU de Caen, Caen, France.

Jean-Luc Pasquié (JL)

PhyMedExp, Université de Montpellier, INSERM, CNRS, CHRU de Montpellier, France.

Bertrand Pierre (B)

CHU de Tours, Tours, France.

Pénélope Pujadas (P)

Hôpital Privé Les Franciscaines, Nîmes, France.

Laure Champ-Rigot (L)

CHU de Caen, Caen, France.

Frédéric Sacher (F)

CHU de Bordeaux, Bordeaux, France.

Nicolas Sadoul (N)

CHU Nancy, Nancy, France.

Alexandre Schatz (A)

CHU de Strasbourg, Strasbourg, France.

Pierre Winum (P)

CHU de Nîmes, Nîmes, France.

Paul-Ursmar Milliez (PU)

CHU de Caen, Caen, France.

Vincent Probst (V)

CHU de Nantes, Nantes, France.

Eloi Marijon (E)

Université de Paris, INSERM, Paris Cardiovascular Research Centre, Paris, France; Pediatric and Congenital Medico-Surgical Unit, Necker Hospital, Paris, France.

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