Long-term outcomes of subcutaneous implantable cardioverter defibrillators: the French nationwide HONEST study.
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Kerkouri Fawzi, Marquié Christelle, Boveda Serge, Anselme Frédéric, Anys Soraya, Badenco Nicolas, Bessiere Francis, Blangy Hugues, Bordachar Pierre, Champ-Rigot Laure, Chauvin Michel, Clementy Nicolas, Clerici Gaël, Da Costa Antoine, Defaye Pascal, De Guillebon Maxime, Deharo Jean-Claude, Eschalier Romain, Extramiana Fabrice, Fauchier Laurent, Frey Pierre, Gandjbakhch Estelle, Guenancia Charles, Guy-Moyat Benoit, Hermida Alexis, Hourdain Jérôme, Jacon Peggy, Jesel Laurence, Lacotte Jérôme, Leclercq Christophe, Lellouche Nicolas, Mansourati Jacques, Maury Philippe, Menet Aymeric, Mondoly Pierre, Montoy Mathieu, Narayanan Kumar, Pasquié Jean-Luc, Perrot David, Pierre Bertrand, Sacher Frédéric, Sadoul Nicolas, Waldmann Victor, Garcia Rodrigue, Probst Vincent, Marijon Eloi, the HONEST Study Investigators
Аннотация
METHODS: HONEST is a ongoing nationwide academic observational study enrolling 98.2% of patients implanted with an S-ICD across France (2012-2019). Five-year clinical endpoints were centrally adjudicated.
RESULTS: Overall, 4924 patients were enrolled (mean age 49.9 ± 15 years, 76.7% male, 63.0% for primary prevention). Implants used general anaesthesia (78.9%), and defibrillation testing (82.6%). Perioperative complications (within 30 days) occurred in 4.4%. At 5 years, cumulative incidence rates were 13.8% for inappropriate shocks, 10.8% for early battery depletion, 2.4% for infections, 1.5% for lead dysfunction, and 1.4% for chronic discomfort. Reoperation was required in 16.9%, need for cardiac pacing in 3.1%, and definite S-ICD extraction in 8.4%. Inappropriate shocks were independently associated with male sex (hazard ratio [HR] 1.29, 95% confidence interval [CI] 1.14-1.46, P < .001), obesity (HR 1.35, 95% CI 1.02-1.79, P = .032), arrhythmogenic right ventricular cardiomyopathy (HR 1.70, 95% CI 1.03-2.81, P = .036), and the presence of a pacemaker (HR 2.20, 95% CI 1.16-4.17, P = .016). SMART Pass filtering significantly reduced inappropriate shocks (HR 0.67, 95% CI 0.50-0.89, P = .007). Among patients with inappropriate shocks, ∼1% developed induced ventricular fibrillation (one fatality), and 10% underwent device extraction. Ineffective shocks or undetected arrhythmias occurred in only 0.2%. Among 547 deaths (11.1%), 53.9% were cardiovascular, including 26 sudden deaths, and 8 were S-ICD/procedure-related, with none related to S-ICD extraction.
CONCLUSIONS: This nationwide study refines the long-term event profile of S-ICD therapy and may inform clinical practice and device selection.