Dello Russo Antonio, Tondo Claudio, Bianchi Stefano, Schillaci Vincenzo, Iacopino Saverio, Casella Michela, Rossillo Antonio, Maggio Ruggero, Themistoclakis Sakis, Bertini Matteo, Russo Maurizio, Volpicelli Mario, Viola Graziana, Rordorf Roberto, Schiavone Marco, Valeri Yari, Colella Jacopo, Rossi Pietro, Tundo Fabrizio, Zingarini Gianluca, De Simone Antonio, Bianchini Lorenzo, Di Vilio Alessandro, Compagnucci Paolo, Malacrida Maurizio, Zucchelli Giulio, Solimene Francesco
Department of Biomedical Sciences and Public Health Marche Polytechnic University Ancona Italy.
Department of Cardiology and Arrhythmology Clinic Marche University Hospital Ancona Italy.
J Am Heart Assoc. 2025 May 6;14(9):e037959. doi: 10.1161/JAHA.124.037959. Epub 2025 Apr 23.
There is no evidence evaluating efficiency, effectiveness, and safety outcomes in older patients in the context of pulsed-field ablation technology for the ablation of atrial fibrillation. We aimed to compare safety, efficacy, and acute and long-term outcomes of pulsed-field ablation in older patients (≥75 years) with younger ones.
We enrolled consecutive patients who had undergone atrial fibrillation ablation with the pulsed-field ablation FARAPULSE system (Boston Scientific) at 15 centers. Patients were stratified by age (<65, 65-74, and ≥75 years) and efficacy and safety profiles of these groups were compared.
A total of 1082 patients were included: 108 (10%) were ≥75 years old, 374 (34.6%) were 65-74 years old and 600 (55.4%) were <65 years old. Older patients displayed a more pronounced risk profile compared with their younger counterparts, characterized by a significant higher burden of comorbidities. No differences in terms of procedural metrics were found. Pulmonary vein isolation was achieved in all patients. An overall low rate of procedural-related complications was reported (3.0%) without difference between young and older patients (=0.241). During a mean follow-up of 342±111 days, a primary efficacy end point occurred in 605 of 748 (80.9%) patients with available outcome information. The arrhythmia recurrence rate ranged from 14.4% in patients <65 years old to 26.9% of older patients (=0.011).
Drawing from these findings, using the FARAPULSE system for atrial fibrillation ablation in older patients demonstrated swift, safe, and effective acute outcomes, mirroring a comparable pattern observed in younger patients and recurrence rates in line with the literature in older patients.
URL: clinicaltrials.gov; Unique Identifier: NCT05617456.
在心房颤动消融的脉冲场消融技术背景下,尚无证据评估老年患者的效率、有效性和安全性结果。我们旨在比较老年患者(≥75岁)与年轻患者进行脉冲场消融的安全性、有效性以及急性和长期结果。
我们纳入了在15个中心接受使用脉冲场消融FARAPULSE系统(波士顿科学公司)进行心房颤动消融的连续患者。患者按年龄分层(<65岁、65 - 74岁和≥75岁),并比较这些组的疗效和安全性概况。
共纳入1082例患者:108例(10%)年龄≥75岁,374例(34.6%)年龄在65 - 74岁,600例(55.4%)年龄<65岁。与年轻患者相比,老年患者表现出更明显的风险特征,其特点是合并症负担显著更高。在手术指标方面未发现差异。所有患者均实现了肺静脉隔离。报告的手术相关并发症总体发生率较低(3.0%),年轻患者和老年患者之间无差异(P = 0.241)。在平均342±111天的随访期间,748例有可用结局信息的患者中有605例(80.9%)出现了主要疗效终点。心律失常复发率在<65岁的患者中为14.4%,在老年患者中为26.9%(P = 0.011)。
基于这些发现,在老年患者中使用FARAPULSE系统进行心房颤动消融显示出迅速、安全且有效的急性结果,与年轻患者中观察到的类似模式相符,复发率与老年患者的文献一致。
网址:clinicaltrials.gov;唯一标识符:NCT05617456。