Sex differences among subcutaneous implantable cardioverter-defibrillator recipients: a propensity-matched, multicentre, international analysis from the i-SUSI project

• Published in: Europace (London, England) England), 2024-05, Vol.26 (5)
• Main Authors: Schiavone, Marco, Gasperetti, Alessio, Vogler, Julia, Compagnucci, Paolo, Laredo, Mikael, Breitenstein, Alexander, Gulletta, Simone, Martinek, Martin, Kaiser, Lukas, Tundo, Fabrizio, Palmisano, Pietro, Rovaris, Giovanni, Curnis, Antonio, Kuschyk, Jürgen, Biffi, Mauro, Tilz, Roland, Di Biase, Luigi, Tondo, Claudio, Forleo, Giovanni B
• Format: Article
• Language: English
• Subjects: Aged; Arrhythmias, Cardiac - therapy; Clinical Research; Death, Sudden, Cardiac - prevention & control; Defibrillators, Implantable; Electric Countershock - adverse effects; Electric Countershock - instrumentation; Europe; Female; Humans; Male; Middle Aged; Propensity Score; Registries; Risk Assessment; Risk Factors; Sex Factors; Time Factors; Treatment Outcome
• ISSN: 1099-5129; 1532-2092; 1532-2092
• DOI: 10.1093/europace/euae115

Women have been historically underrepresented in implantable cardioverter-defibrillator (ICD) trials. No data on sex differences regarding subcutaneous ICDs (S-ICD) carriers have been described. Aim of our study was to investigate sex-related differences among unselected S-ICD recipients. Consecutive patients enrolled in the multicentre, international i-SUSI registry were analysed. Comparisons between sexes were performed using a 1:1 propensity matching adjusted analysis for age, body mass index (BMI), left ventricular function, and substrate. The primary outcome was the rate of appropriate shocks during follow-up. Inappropriate shocks and other device-related complications were deemed secondary outcomes. A total of 1698 patients were extracted from the i-SUSI registry; 399 (23.5%) were females. After propensity matching, two cohorts of 374 patients presenting similar baseline characteristics were analysed. Despite similar periprocedural characteristics and a matched BMI, women resulted at lower risk of conversion failure as per PRAETORIAN score (73.4% vs. 81.3%, P = 0.049). Over a median follow-up time of 26.5 [12.7-42.5] months, appropriate shocks were more common in the male cohort (rate/year 3.4% vs. 1.7%; log-rank P = 0.049), while no significant differences in device-related complications (rate/year: 6.3% vs. 5.8%; log-rank P = 0.595) and inappropriate shocks (rate/year: 4.3% vs. 3.1%; log-rank P = 0.375) were observed. After controlling for confounders, sex remained significantly associated with the primary outcome (aHR 1.648; CI 0.999-2.655, P = 0.048), while not resulting predictor of inappropriate shocks and device-related complications. In a propensity-matched cohort of S-ICD recipients, women are less likely to experience appropriate ICD therapy, while not showing higher risk of device-related complications. ClinicalTrials.gov Identifier: NCT0473876.