Schmidt Boris, Bordignon Stefano, Metzner Andreas, Sommer Philipp, Steven Daniel, Dahme Tilmann, Busch Matthias, Tilz Roland Richard, Schaack David, Rillig Andreas, Sohns Christian, Sultan Arian, Weinmann-Emhardt Karolina, Hummel Astrid, Vogler Julia, Fink Thomas, Lueker Jakob, Pott Alexander, Heeger Christian, Chun K R Julian
Cardioangiologisches Centrum Bethanien, Frankfurt, Germany (B.S., S.B., D. Schaack, K.-R.J.C.).
Universitätsklinikum Frankfurt, Medizinische Klinik 3-Klinik für Kardiologie, Frankfurt, Germany (B.S.).
Circulation. 2024 Dec 17;150(25):2007-2018. doi: 10.1161/CIRCULATIONAHA.124.069993. Epub 2024 Oct 7.
Ablation strategies for patients with symptomatic atrial fibrillation and isolated pulmonary veins vary and their effects on arrhythmia recurrence remain unclear. A prospective randomized German multicenter trial sought to compare 2 ablation strategies in this patient cohort.
Patients with atrial fibrillation despite durable pulmonary vein isolation were randomly assigned at 7 centers to undergo low-voltage area ablation using 3-dimensional mapping and irrigated radiofrequency current ablation (group A) or empirical left atrial appendage isolation (LAAI) using the cryoballoon followed by staged interventional left atrial appendage closure (group B). The primary end point was freedom from atrial tachyarrhythmias between 91 and 365 days after index ablation. The study was powered for superiority of LAAI compared with low-voltage area.
Patients (40% women; mean age, 68.8±8 years) with paroxysmal (32%) or persistent atrial fibrillation (68%) were randomized to undergo low-voltage area ablation (n=79) or cryoballoon-guided LAAI (n=82). After a planned interim analysis, enrollment was halted for futility on January 10, 2023. In the LAAI group, 77 of 82 left atrial appendages were successfully isolated with subsequent left atrial appendage closure in 57 patients. Procedure-related complications occurred in 4 (5%) and 11 (13.5%) patients in group A and B, respectively (=0.10). The median follow-up was 367 days (interquartile range, 359-378). The Kaplan-Meier point estimate for freedom from atrial tachyarrhythmias was 51.7% (CI, 40.9%-65.4%) for group A and 55.5% (CI, 44.4%-69.2%; =0.8069) for group B.
The current study did not detect superiority of cryoballoon-guided LAAI over low-voltage area ablation in patients with atrial fibrillation despite durable PVI.
URL: https://www.clinicaltrials.gov; Unique identifier: NCT04056390.
有症状的心房颤动和孤立肺静脉患者的消融策略各不相同，其对心律失常复发的影响尚不清楚。一项前瞻性随机德国多中心试验旨在比较该患者队列中的两种消融策略。
尽管肺静脉隔离持久，但仍患有心房颤动的患者在7个中心被随机分配，接受使用三维标测和灌注射频电流消融的低电压区消融（A组），或使用冷冻球囊进行经验性左心耳隔离（LAAI），随后进行分期介入性左心耳封堵（B组）。主要终点是首次消融后91至365天内心房快速性心律失常的缓解。该研究旨在证明LAAI优于低电压区消融。
阵发性（32%）或持续性心房颤动（68%）的患者（40%为女性；平均年龄68.8±8岁）被随机分配接受低电压区消融（n = 79）或冷冻球囊引导的LAAI（n = 82）。经过计划中的中期分析，于2023年1月10日因无效而停止入组。在LAAI组中，82个左心耳中的77个成功隔离，57例患者随后进行了左心耳封堵。A组和B组分别有4例（5%）和11例（13.5%）患者发生与手术相关的并发症（P = 0.10）。中位随访时间为367天（四分位间距，359 - 378）。A组无心房快速性心律失常的Kaplan - Meier点估计值为51.7%（CI，40.9% - 65.4%），B组为55.5%（CI，44.4% - 69.2%；P = 0.8069）。
在尽管肺静脉隔离持久但仍患有心房颤动的患者中，当前研究未发现冷冻球囊引导的LAAI优于低电压区消融。
