Efficacy and safety of a novel hexaspline pulsed field ablation system in patients with paroxysmal atrial fibrillation: the PLEASE-AF study.

IF 7.9 1区 医学 Q1 CARDIAC & CARDIOVASCULAR SYSTEMS Europace Pub Date : 2024-07-02 DOI:10.1093/europace/euae174
Zulu Wang, Min Tang, Vivek Y Reddy, Huimin Chu, Xingpeng Liu, Yumei Xue, Jingfeng Wang, Jing Xu, Shaowen Liu, Wei Xu, Zhihui Zhang, Bing Han, Lang Hong, Bing Yang, Mingying Ding, Ming Liang
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Abstract

Aims: Pulsed field ablation (PFA) is an emerging non-thermal ablative modality demonstrating considerable promise for catheter ablation of atrial fibrillation (AF). However, these PFA trials have almost universally included only Caucasian populations, with little data on its effect on other races/ethnicities. The PLEASE-AF trial sought to study the 12-month efficacy and the safety of a multi-electrode hexaspline PFA catheter in treating a predominantly Asian/Chinese population of patients with drug-refractory paroxysmal AF.

Methods and results: Patients underwent pulmonary vein (PV) isolation (PVI) by delivering different pulse intensities at the PV ostium (1800 V) and atrium (2000 V). Acute success was defined as no PV potentials and entrance/exit conduction block of all PVs after a 20-min waiting period. Follow-up at 3, 6, and 12 months included 12-lead electrocardiogram and 24-h Holter examinations. The primary efficacy endpoint was 12-month freedom from any atrial arrhythmias lasting at least 30 s. The cohort included 143 patients from 12 hospitals treated by 28 operators: age 60.2 ± 10.0 years, 65.7% male, Asian/Chinese 100%, and left atrial diameter 36.6 ± 4.9 mm. All PVs (565/565, 100%) were successfully isolated. The total procedure, catheter dwell, total PFA application, and total fluoroscopy times were 123.5 ± 38.8 min, 63.0 ± 30.7 min, 169.7 ± 34.6 s, and 27.3 ± 10.1 min, respectively. The primary endpoint was observed in 124 of 143 patients (86.7%). One patient (0.7%) developed a small pericardial effusion 1-month post-procedure, not requiring intervention.

Conclusion: The novel hexaspline PFA catheter demonstrated universal acute PVI with an excellent safety profile and promising 12-month freedom from recurrent atrial arrhythmias in an Asian/Chinese population with paroxysmal AF.

Clinical trial registration: ClinicalTrials.gov Identifier: NCT05114954.

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新型六线脉冲场消融系统对阵发性心房颤动患者的疗效和安全性:PLEASE-AF 研究。
目的:脉冲场消融术(PFA)是一种新兴的非热消融方式,在心房颤动(AF)的导管消融方面前景广阔。然而,这些 PFA 试验几乎都只包括白种人,很少有数据显示其对其他种族/民族的影响。PLEASE-AF 试验旨在研究多电极六线 PFA 导管治疗以亚洲人/中国人为主的药物难治性阵发性房颤患者的 12 个月疗效和安全性:通过在肺静脉骨膜(1800 V)和心房(2000 V)提供不同脉冲强度,对患者进行肺静脉(PV)隔离(PVI)。急性成功的定义是在 20 分钟等待期后所有肺静脉无电位和入口/出口传导阻滞。3、6 和 12 个月的随访包括 12 导联心电图和 24 小时 Holter 检查。主要疗效终点是 12 个月内无至少持续 30 秒的房性心律失常。队列包括来自 12 家医院的 143 名患者,由 28 名操作者进行治疗:年龄(60.2±10.0)岁,65.7% 为男性,100% 为亚洲人/中国人,左心房直径(36.6±4.9)毫米。所有 PV(565/565,100%)均成功分离。手术总时间、导管停留时间、PFA应用总时间和透视总时间分别为(123.5 ± 38.8)分钟、(63.0 ± 30.7)分钟、(169.7 ± 34.6)秒和(27.3 ± 10.1)分钟。143 例患者中有 124 例(86.7%)达到了主要终点。一名患者(0.7%)在术后1个月出现了少量心包积液,但无需干预:结论:新型hexaspline PFA导管在亚洲/中国阵发性房颤患者中具有普遍的急性PVI效果,安全性极佳,有望在12个月内避免复发房性心律失常:临床试验注册:ClinicalTrials.gov Identifier:临床试验注册:ClinicalTrials.gov Identifier:NCT05114954。
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来源期刊
Europace
Europace 医学-心血管系统
CiteScore
10.30
自引率
8.20%
发文量
851
审稿时长
3-6 weeks
期刊介绍: EP - Europace - European Journal of Pacing, Arrhythmias and Cardiac Electrophysiology of the European Heart Rhythm Association of the European Society of Cardiology. The journal aims to provide an avenue of communication of top quality European and international original scientific work and reviews in the fields of Arrhythmias, Pacing and Cellular Electrophysiology. The Journal offers the reader a collection of contemporary original peer-reviewed papers, invited papers and editorial comments together with book reviews and correspondence.
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