Migliore Federico, Ottaviano Luca, Arestia Alberto, Nigro Gerardo, Dello Russo Antonio, Viani Stefano, Bianchi Valter, Bisignani Antonio, Pieragnoli Paolo, Vitulano Gennaro, Rordorf Roberto, Francia Pietro, Taravelli Erika, Pisanò Ennio, Lavalle Carlo, Brambilla Roberta, Ziacchi Matteo, Rapacciuolo Antonio, Viscusi Miguel, De Filippo Paolo, La Greca Carmelo, Pepi Patrizia, Notarstefano Pasquale, Curcio Antonio, Pittorru Raimondo, Martini Nicolò, Seganti Alessandro, Napolitano Carlo, Lovecchio Mariolina, Valsecchi Sergio, Botto Gianluca, Priori Silvia G
Department of Cardiac, Thoracic, and Vascular Sciences and Public Health University of Padova, Padova, Italy.
Arrhythmia and Electrophysiology Unit, Cardiothoracic Department IRCCS Galeazzi - Sant' Ambrogio, Milan, Italy.
JACC Clin Electrophysiol. 2025 Jul;11(7):1572-1582. doi: 10.1016/j.jacep.2025.03.003. Epub 2025 Mar 29.
The implantable cardioverter-defibrillator (ICD) is recognized as the most effective life-saving therapy in patients with Brugada syndrome (BrS). However, transvenous ICD is associated with a notable rate of complications over time. The subcutaneous implantable cardioverter-defibrillator (S-ICD) has emerged as a promising alternative to the transvenous ICD. Nevertheless, long-term data from large cohorts of BrS patients with S-ICDs are lacking.
This multicenter study aimed to assess the long-term outcomes of S-ICD therapy in patients with BrS.
The study included 450 consecutive BrS patients (mean age 43 ± 12; 86% male) who underwent S-ICD implantation between 2014 and 2024.
During a median follow-up of 52 months (25th-75th percentile: 29-72), appropriate shocks were delivered in 3% of patients (1.2%; 95% CI: 0.2-2.2, at 12 months), with a first-shock success rate of 90% (100% with 2 shocks). Inappropriate shocks occurred in 7% of patients (1.4%; 95% CI: 0.3-2.5, at 12 months). Shock zone programmed at 250 beats/min (HR: 0.40; 95% CI: 0.18-0.89; P = 0.025) and more than 1 suitable vector on screening (HR: 0.39; 95% CI: 0.17-0.87; P = 0.023) were independent protective factors against inappropriate shock. Device-related complications were reported in 4% of patients (2.5%; 95% CI: 1.0-3.9 at 12 months). The need for antibradycardia pacing was reported in 3 patients (0.7%). No device explantation because of the need for antitachycardia pacing was noted.
Our findings support the S-ICD as a viable alternative to the transvenous ICD for preventing sudden cardiac death in BrS patients without pacing indication (Arrhythmias Detection in a Real World Population [RHYTHM DETECT]; NCT02275637).
植入式心律转复除颤器(ICD)被认为是布加综合征(BrS)患者最有效的挽救生命的治疗方法。然而,随着时间的推移,经静脉ICD与显著的并发症发生率相关。皮下植入式心律转复除颤器(S-ICD)已成为经静脉ICD的一种有前景的替代方案。尽管如此,缺乏来自大量使用S-ICD的BrS患者队列的长期数据。
这项多中心研究旨在评估S-ICD治疗BrS患者的长期疗效。
该研究纳入了2014年至2024年间连续接受S-ICD植入的450例BrS患者(平均年龄43±12岁;86%为男性)。
在中位随访52个月期间(第25-75百分位数:29-72个月),3%的患者接受了恰当电击(12个月时为1.2%;95%置信区间:0.2-2.2%),首次电击成功率为90%(两次电击后成功率为100%)。7%的患者发生了不恰当电击(12个月时为1.4%;95%置信区间:0.3-2.5%)。将电击区程控为250次/分钟(HR:0.40;95%置信区间:0.18-0.89;P = 0.025)以及筛查时有多个合适向量(HR:0.39;95%置信区间:0.17-0.87;P = 0.023)是防止不恰当电击的独立保护因素。4%的患者报告了与设备相关的并发症(12个月时为2.5%;95%置信区间:1.0-3.9%)。3例患者(0.7%)报告需要抗心动过缓起搏。未发现因需要抗心动过速起搏而进行设备取出的情况。
我们的研究结果支持S-ICD作为经静脉ICD的可行替代方案,用于预防无起搏指征的BrS患者的心源性猝死(真实世界人群中的心律失常检测[RHYTHM DETECT];NCT02275637)。