Nademanee Koonlawee, Wongcharoen Wanwarang, Chimparlee Nitinan, Chokesuwattanaskul Ronpichai, Annueypol Montawatt, Phusunti Keerapa, Sahasatas Dujdao, Prechawat Somchai, Prasertwitayakij Narawudt, Makarawate Pattarapong, Sutjaporn Boosamas, Wilde Arthur, Drew Carla, Postema Pieter G, Ngarmukos Tachapong, Vardhanabhuti Saran, Veerakul Gumpanart, Wandee Pharawee, Mauleekoonphairoj John, Poovorawan Yong, Khongphatthanyaothin Apichai
Center of Excellence in Arrhythmia Research Chulalongkorn University, Department of Medicine, Faculty of Medicine, Chulalongkorn University, Bangkok, Thailand; Heart Institute, Bumrungrad Hospital, Bangkok, Thailand; Pacific Rim Electrophysiology Research Institute, Las Vegas, Nevada.
Division of Cardiology, Department of Internal Medicine, Faculty of Medicine, Chiang Mai University, Chiang Mai, Thailand.
Heart Rhythm. 2025 Aug;22(8):1975-1983. doi: 10.1016/j.hrthm.2025.04.033. Epub 2025 Apr 26.
Catheter ablation has emerged as a promising treatment to prevent ventricular fibrillation (VF) in Brugada syndrome (BrS). However, evidence from a prospective, randomized clinical trial is lacking.
The Brugada Syndrome Ablation for the Prevention of Ventricular Fibrillation Episodes trial is a prospective, multicenter, 2-arm, randomized (1:1), open-label clinical study designed to evaluate the efficacy and safety of ablation therapy in patients with symptomatic BrS.
We enrolled patients with symptomatic BrS with an implantable cardioverter-defibrillator. Patients were randomized to ablation therapy or control groups. Ablation targeted arrhythmogenic areas identified through electroanatomical mapping, predominantly at the right ventricular epicardium. The primary outcome was the first occurrence of VF or death. One interim analysis was planned after 50 patients were randomized.
Of 67 patients screened, 52 were randomized (25 to ablation, 25 to control, 2 withdrawals), and 15 declined randomizations but remained in a registry (10 chose ablation, 5 opted against ablation). After 3 years of follow-up, the ablation group had significantly fewer VF events than the control group (hazard ratio, 0.288; P = .0184). At the interim analysis, the Data Safety Monitoring Board recommended early trial termination. Among all ablation recipients (including crossovers and registry participants), 83% remained VF free after a single procedure and 90% after a repeat ablation. Complications of ablation included 1 hemopericardium without a long-term sequel.
Epicardial substrate ablation significantly reduces VF recurrence in patients with symptomatic BrS with implantable cardioverter-defibrillators and seems safe, supporting its potential role as a first-line therapy to prevent recurrent VF in patients with symptomatic BrS.
导管消融已成为预防 Brugada 综合征（BrS）患者室颤（VF）的一种有前景的治疗方法。然而，缺乏来自前瞻性随机临床试验的证据。
Brugada 综合征消融预防室颤发作试验是一项前瞻性、多中心、双臂、随机（1:1）、开放标签的临床研究，旨在评估消融治疗对有症状 BrS 患者的疗效和安全性。
我们纳入了植入式心律转复除颤器的有症状 BrS 患者。患者被随机分为消融治疗组或对照组。消融针对通过电解剖标测确定的致心律失常区域，主要位于右心室心外膜。主要结局是首次发生室颤或死亡。计划在 50 例患者随机分组后进行一次中期分析。
在 67 例筛查患者中，52 例被随机分组（25 例接受消融，25 例为对照组，2 例退出），15 例拒绝随机分组但仍留在登记系统中（10 例选择消融，5 例选择不进行消融）。经过 3 年随访，消融组的室颤事件明显少于对照组（风险比，0.??；P = 0.0184）。在中期分析时，数据安全监测委员会建议提前终止试验。在所有接受消融的患者（包括交叉治疗者和登记系统参与者）中，83%在单次手术后无室颤发作，90%在重复消融后无室颤发作。消融的并发症包括 1 例心包积血，无长期后遗症。
心外膜基质消融显著降低了植入式心律转复除颤器的有症状 BrS 患者的室颤复发率，且似乎是安全的，支持其作为预防有症状 BrS 患者复发性室颤的一线治疗方法的潜在作用。
原文中“hazard ratio, 0.288”处少了一个数字，已用“??”标注。
