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应用五边形脉冲场消融导管行房颤消融术的 1 年前瞻性研究结果:法国初步经验。

Prospective 1-year results of atrial fibrillation ablation using the pentaspline pulsed field ablation catheter: The initial French experience.

机构信息

Department of Cardiology, CHU de Rouen, 76000 Rouen, France; University of Rouen Normandie, Inserm EnVI UMR 1096, 76000 Rouen, France.

Department of Cardiology, CHU de Rouen, 76000 Rouen, France.

出版信息

Arch Cardiovasc Dis. 2024 Apr;117(4):249-254. doi: 10.1016/j.acvd.2024.01.005. Epub 2024 Mar 5.

Abstract

BACKGROUND

Pulsed field ablation has recently emerged as an interesting non-thermal energy for atrial fibrillation ablation. At a time of rapid spread of this technology, there is still a lack of prospective real-life data.

AIM

To describe multicentre prospective safety and 1-year efficacy data in three of the first French centres to use pulsed field ablation.

METHODS

All consecutive patients undergoing a first pulsed field ablation were included prospectively. The primary outcome was freedom from documented atrial arrhythmia. The safety endpoint was a composite of major adverse events. Univariate and multivariable analyses, including patient and procedural characteristics, were performed to identify factors predictive of recurrence.

RESULTS

Between May 2021 and June 2022, 311 patients were included (paroxysmal atrial fibrillation in 53%, persistent atrial fibrillation in 35% and long-standing persistent atrial fibrillation in 11%). Additional non-pulmonary vein pulsed field ablation applications were performed in 104/311 patients. One-year freedom from arrhythmia recurrence was 77.6% in the overall population and was significantly higher in patients with paroxysmal atrial fibrillation (88.4%) compared with patients with persistent atrial fibrillation (69.7%; P<0.001) and those with long-standing persistent atrial fibrillation (49.0%; P<0.001). The major complication rate was 2.6% (tamponade in four patients, stroke in two patients and coronary spasm in one patient). Besides the usual predictors of recurrences (left atrium size, CHADS-VASc score, type of atrial fibrillation), the presence of atrial fibrillation at procedure start was independently associated with arrhythmia recurrence (hazard ratio: 2.04, 95% confidence interval: 1.10-3.77).

CONCLUSION

In this prospective multicentre real-world study, pulsed field ablation for atrial fibrillation ablation seems to be associated with a good safety profile and rather favourable acute and 1-year success rates.

摘要

背景

脉冲场消融技术最近作为一种非热能量在房颤消融中崭露头角。在这项技术迅速普及的同时,仍然缺乏前瞻性的真实数据。

目的

描述三个法国最早使用脉冲场消融技术的中心的前瞻性安全性和 1 年疗效数据。

方法

所有连续接受首次脉冲场消融的患者均前瞻性纳入研究。主要终点是无有记录的房性心律失常的比例。安全性终点是主要不良事件的复合终点。采用单变量和多变量分析,包括患者和手术特征,以确定复发的预测因素。

结果

2021 年 5 月至 2022 年 6 月期间,共纳入 311 例患者(阵发性房颤占 53%,持续性房颤占 35%,持久性持续性房颤占 11%)。104/311 例患者进行了额外的非肺静脉脉冲场消融应用。总体人群中 1 年无心律失常复发率为 77.6%,阵发性房颤患者明显高于持续性房颤患者(88.4%比 69.7%;P<0.001)和持久性持续性房颤患者(49.0%;P<0.001)。主要并发症发生率为 2.6%(4 例患者发生心包填塞,2 例患者发生卒中,1 例患者发生冠状动脉痉挛)。除了复发的常见预测因素(左心房大小、CHADS-VASc 评分、房颤类型)外,手术开始时存在房颤也与心律失常复发独立相关(风险比:2.04,95%置信区间:1.10-3.77)。

结论

在这项前瞻性多中心真实世界研究中,脉冲场消融治疗房颤似乎具有良好的安全性和相当有利的急性和 1 年成功率。

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