Europace : European pacing, arrhythmias, and cardiac electrophysiology : journal of the working groups on cardiac pacing, arrhythmias, and cardiac cellular electrophysiology of the European Society of Cardiology · 2025
Epicardial ablation in high-risk Brugada syndrome to prevent ventricular fibrillation: results from a randomized clinical trial.
СтатьяРандомизированное исследованиеНазвание и аннотация: Перевод пока не подготовлен
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Pappone Carlo, Ciconte Giuseppe, Vicedomini Gabriele, Micaglio Emanuele, Boccellino Antonio, Negro Gabriele, Giannelli Luigi, Rondine Roberto, Creo Pasquale, Tarantino Adriana, Ballarotto Marco, Maiolo Vincenzo, Ciaccio Cristiano, Manuello Roberto, Locati Emanuela T, Mazza Beniamino C, Vecchi Mattia, Ćalović Žarko, Anastasia Luigi
Аннотация
AIMS: Epicardial ablation for Brugada syndrome (BrS) has shown promise in reducing ventricular fibrillation (VF), but its role remains controversial due to the lack of randomized trials. This study evaluates the efficacy of catheter ablation in high-risk BrS patients.
METHODS AND RESULTS: This prospective, single-centre, randomized (2:1) study enrolled BrS patients with cardiac arrest (CA) or appropriate ICD therapies. All patients had an ICD and were randomized to undergo epicardial ablation (ablation group) or no ablation (control group). Enrolment began in September 2017 and prematurely terminated in February 2024. The primary endpoint was freedom from VF recurrences. Secondary endpoints included procedure safety, ICD-related complications, and quality-of-life assessment. Forty patients (83% male, mean age 43.7 ± 12.1) were randomized: 26 in the ablation group and 14 in the control group. Thirty-six patients received appropriate ICD therapies before enrolment: 24 (92%) in the ablation group and 12 (86%) in the control group. One patient in the ablation group experienced a post-procedural pericardial effusion requiring pericardiocentesis. Thirteen patients (33%) had major ICD-related complications. After a mean follow-up of 4.0 ± 1.7 years, freedom from VF recurrence was 96% (25/26) in the ablation group and 50% (7/14) in the control group (P < 0.001). No unexplained or arrhythmic deaths occurred during follow-up.
CONCLUSION: Epicardial catheter ablation was associated with a reduction in VF recurrence compared with ICD therapy alone. These findings support the use of epicardial ablation in high-risk BrS patients.
CLINICALTRIALS.GOV: ID NCT03294278.
METHODS AND RESULTS: This prospective, single-centre, randomized (2:1) study enrolled BrS patients with cardiac arrest (CA) or appropriate ICD therapies. All patients had an ICD and were randomized to undergo epicardial ablation (ablation group) or no ablation (control group). Enrolment began in September 2017 and prematurely terminated in February 2024. The primary endpoint was freedom from VF recurrences. Secondary endpoints included procedure safety, ICD-related complications, and quality-of-life assessment. Forty patients (83% male, mean age 43.7 ± 12.1) were randomized: 26 in the ablation group and 14 in the control group. Thirty-six patients received appropriate ICD therapies before enrolment: 24 (92%) in the ablation group and 12 (86%) in the control group. One patient in the ablation group experienced a post-procedural pericardial effusion requiring pericardiocentesis. Thirteen patients (33%) had major ICD-related complications. After a mean follow-up of 4.0 ± 1.7 years, freedom from VF recurrence was 96% (25/26) in the ablation group and 50% (7/14) in the control group (P < 0.001). No unexplained or arrhythmic deaths occurred during follow-up.
CONCLUSION: Epicardial catheter ablation was associated with a reduction in VF recurrence compared with ICD therapy alone. These findings support the use of epicardial ablation in high-risk BrS patients.
CLINICALTRIALS.GOV: ID NCT03294278.