脉冲场消融治疗持续性心房颤动

IF 21.7 1区医学 Q1 CARDIAC & CARDIOVASCULAR SYSTEMS

Journal of the American College of Cardiology Pub Date : 2025-04-28 DOI:10.1016/j.jacc.2025.03.515

Vivek Y. Reddy MD , Edward P. Gerstenfeld MD , Boris Schmidt MD , Devi Nair MD , Andrea Natale MD , Walid Saliba MD , Atul Verma MD , Philipp Sommer MD , Andreas Metzner MD , Mohit Turagam MD , Stanislav Weiner MD , Jean Champagne MD , Ignacio Garcio-Bolao MD, PhD , Hugh Calkins MD , Jeffrey Olson MD , Ziad Issa MD , Marshall Winner MD , Wilber Su MD , Gery Tomassoni MD , Jamie Kim MD , Kapil Kumar

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引用次数: 0

摘要

背景：脉冲场消融（PFA）在肺静脉隔离（PVI）治疗房颤方面得到了突出的应用，但PFA治疗持续性房颤（PerAF）的结果数据有限。目的本研究旨在确定PVI + PFA后壁消融（PWA）治疗PerAF的安全性和有效性。advantage AF （FARAPULSE脉冲场消融系统在持续性房颤患者中的前瞻性单臂开放标签研究）是一项前瞻性，单臂，多中心关键研究性器械免除研究，适用于使用pentaspline PFA导管接受PVI+PWA的PerAF患者。1年随访包括在6个月和12个月进行24小时动态心电图监测，每月进行两次有症状的经电话监测。主要的安全性终点是预先确定的不良事件的发生率。主要疗效终点包括急性成功和空白后1年内无房性心动过速复发（30秒）、重新消融、心律转复或抗心律失常药物升级。终点分析采用Kaplan-Meier方法，单侧置信限为97.5%，安全性目标为12%，有效性目标为40%，有效性目标为85%。结果339例患者（治疗260例，入组79例）spfa治疗PVI和PWA的成功率为99.7%。主要安全终点为2.3%（置信上限5.1%），包括心包炎1例，心肌梗死1例，肺水肿4例；无填塞、脑卒中、肺静脉狭窄、食管瘘发生。1年的主要有效性为63.5%（低置信限57.3%），其中8.5%的患者有单次孤立性房颤复发。无症状房颤者85.3%；疗效因操作者经验而异。advantage AF是首个使用PVI和后壁隔离策略的PFA治疗PerAF的大型前瞻性研究，显示了良好的安全性和有效性结果。FARAPULSE脉冲场消融系统在持续性心房颤动患者中的单臂开放性研究[ADVANTAGE AF]；NCT05443594)。

本文章由计算机程序翻译，如有差异，请以英文原文为准。

Pulsed Field Ablation for Persistent Atrial Fibrillation

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Pulsed Field Ablation for Persistent Atrial Fibrillation

Background

Pulsed field ablation (PFA) has gained prominence for pulmonary vein isolation (PVI) to treat atrial fibrillation, but there are limited outcome data on PFA to treat persistent atrial fibrillation (PerAF).

Objectives

This study sought to determine the safety and efficacy of PVI + posterior wall ablation (PWA) with PFA in PerAF.

Methods

ADVANTAGE AF (A Prospective Single Arm Open Label Study of the FARAPULSE Pulsed Field Ablation System in Subjects with Persistent Atrial Fibrillation) is a prospective, single-arm, multicenter pivotal investigational device exemption study of PerAF patients undergoing PVI+PWA with the pentaspline PFA catheter. One-year follow-up included 24-hour Holter monitoring at 6 and 12 months and twice monthly and symptomatic transtelephonic monitoring. The primary safety endpoint was incidence of predefined adverse events. The primary effectiveness endpoint included acute success and postblanking 1-year freedom from atrial tachyarrhythmia recurrence (>30 seconds), redo ablation, cardioversion, or antiarrhythmic drug escalation. Endpoint analysis used Kaplan-Meier methodology with 97.5% 1-sided confidence limits compared with a 12% safety and 40% effectiveness goals, with 85% power.

Results

PFA in 339 patients (260 treatment and 79 roll-in) resulted in 99.7% success for both PVI and PWA. The primary safety endpoint was 2.3% (5.1% upper confidence limit), including 1 with pericarditis, 1 with myocardial infarction, and 4 with pulmonary edema; no tamponade, stroke, pulmonary vein stenosis, or esophageal fistula occurred. Primary effectiveness was 63.5% (57.3% lower confidence limit) at 1 year, with 8.5% patients having a single, isolated atrial fibrillation recurrence. Freedom from symptomatic atrial fibrillation was 85.3%; efficacy varied by operator experience.

Conclusions

ADVANTAGE AF, the first large prospective study of PFA to treat PerAF using a strategy of PVI and posterior wall isolation, revealed favorable safety and effectiveness outcomes. (A Prospective Single Arm Open Label Study of the FARAPULSE Pulsed Field Ablation System in Subjects with Persistent Atrial Fibrillation [ADVANTAGE AF]; NCT05443594).

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来源期刊

Journal of the American College of Cardiology 医学-心血管系统

CiteScore

42.70

自引率

3.30%

发文量

5097

审稿时长

2-4 weeks

期刊介绍： The Journal of the American College of Cardiology (JACC) publishes peer-reviewed articles highlighting all aspects of cardiovascular disease, including original clinical studies, experimental investigations with clear clinical relevance, state-of-the-art papers and viewpoints. Content Profile: -Original Investigations -JACC State-of-the-Art Reviews -JACC Review Topics of the Week -Guidelines & Clinical Documents -JACC Guideline Comparisons -JACC Scientific Expert Panels -Cardiovascular Medicine & Society -Editorial Comments (accompanying every Original Investigation) -Research Letters -Fellows-in-Training/Early Career Professional Pages -Editor’s Pages from the Editor-in-Chief or other invited thought leaders