Sex Differences in Outcomes of Tetralogy of Fallot Patients With Implantable Cardioverter-Defibrillators.
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Waldmann Victor, Bouzeman Abdeslam, Duthoit Guillaume, Koutbi Linda, Bessière Francis, Labombarda Fabien, Marquié Christelle, Gourraud Jean-Baptiste, Mondoly Pierre, Sellal Jean Marc, Bordachar Pierre, Hermida Alexis, Al Arnaout Alain, Anselme Frédéric, Audinet Caroline, Bernard Yvette, Boveda Serge, Bun Sok Sithikun, Chassignolle Morgane, Clerici Gaël, Da Costa Antoine, de Guillebon Maxime, Defaye Pascal, Elbaz Nathalie, Eschalier Romain, Garcia Rodrigue, Guenancia Charles, Guy-Moyat Benoit, Halimi Franck, Irles Didier, Iserin Laurence, Jourda François, Ladouceur Magalie, Lagrange Philippe, Laredo Mikael, Mansourati Jacques, Massoulié Grégoire, Mathiron Amel, Maury Philippe, Messali Anne, Narayanan Kumar, Nguyen Cédric, Ninni Sandro, Perier Marie-Cécile, Pierre Bertrand, Pujadas Penelope, Sacher Frédéric, Sagnol Pascal, Sharifzadehgan Ardalan, Walton Camille, Winum Pierre, Zakine Cyril, Fauchier Laurent, Martins Raphaël, Pasquié Jean-Luc, Thambo Jean-Benoit, Jouven Xavier, Combes Nicolas, Marijon Eloi
Аннотация
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).