瑞士巴塞尔大学Christian Sticherling小组研究出脉冲场或低温球囊消融治疗阵发性心房颤动。这一研究成果发表在2025年3月31日出版的国际学术期刊《新英格兰医学杂志》上。

背景：肺静脉隔离是治疗阵发性心房颤动的有效方法。脉冲场消融（PFA）是一种非热消融方法，除心肌外几乎没有不良反应。与持续节律监测评估的低温球囊消融相比，PFA后的结果缺乏数据。

方法：在瑞士的这项随机非效性试验中，小组以1:1的比例随机分配有症状的阵发性心房颤动患者接受PFA或冷冻消融。所有患者都接受了植入式心脏监护仪来检测房性心动过速。主要终点是消融后第91天至365天间房性心动过速的首次复发。课题组研究人员使用20个百分点的累积复发率差异来评估非劣效性。安全性终点是手术相关并发症的综合。

结果：共有105名患者被分配接受PFA， 105名患者被分配接受冷冻消融。在第91天至第365天期间，39例PFA组患者和53例冷冻消融组患者出现房性心动过速复发(Kaplan-Meier累积发生率分别为37.1%和50.7%；组间差异为13.6个百分点；95%置信区间为26.9 ~ 0.3；非劣效性P= 0.001，优效性P=0.046)。安全性终点出现在1例PFA患者（1.0%）和2例冷冻消融患者（1.9%）。

研究结果表明，在有症状的阵发性心房颤动患者中，通过持续节律监测评估，PFA在首次房性心动过速复发的发生率方面不低于冷冻球囊消融。

附：英文原文

Title: Pulsed Field or Cryoballoon Ablation for Paroxysmal Atrial Fibrillation

Author: Tobias Reichlin, Thomas Kueffer, Patrick Badertscher, Peter Jüni, Sven Knecht, Gregor Thalmann, Nikola Kozhuharov, Philipp Krisai, Corinne Jufer, Jens Maurhofer, Dik Heg, Tiago V. Pereira, Felix Mahfoud, Helge Servatius, Hildegard Tanner, Michael Kühne, Laurent Roten, Christian Sticherling

Issue&Volume: 2025-03-31

Abstract: BACKGROUND

Pulmonary-vein isolation is an effective treatment for paroxysmal atrial fibrillation. Pulsed field ablation (PFA) is a nonthermal ablation method with few adverse effects beyond the myocardium. Data are lacking on outcomes after PFA as compared with cryoballoon ablation as assessed with continuous rhythm monitoring.

METHODS

In this randomized noninferiority trial in Switzerland, we randomly assigned patients with symptomatic paroxysmal atrial fibrillation in a 1:1 ratio to undergo PFA or cryoablation. All the patients received an implantable cardiac monitor to detect atrial tachyarrhythmias. The primary end point was the first recurrence of an atrial tachyarrhythmia between day 91 and day 365 after ablation. We assessed noninferiority using a margin of 20 percentage points for the difference in the cumulative incidence of recurrence. The safety end point was a composite of procedure-related complications.

RESULTS

A total of 105 patients were assigned to undergo PFA, and 105 were assigned to undergo cryoablation. A recurrence of atrial tachyarrhythmia was observed between day 91 and day 365 in 39 patients in the PFA group and in 53 patients in the cryoablation group (Kaplan–Meier cumulative incidence, 37.1% and 50.7%, respectively; between-group difference, 13.6 percentage points; 95% confidence interval, 26.9 to 0.3; P<0.001 for noninferiority, P=0.046 for superiority). The safety end point occurred in 1 patient (1.0%) with PFA and in 2 patients (1.9%) with cryoablation.

CONCLUSIONS

Among patients with symptomatic paroxysmal atrial fibrillation, PFA was noninferior to cryoballoon ablation with respect to the incidence of a first recurrence of atrial tachyarrhythmia, as assessed by continuous rhythm monitoring.

DOI: NJ202503310000013

Source: https://www.nejm.org/doi/full/10.1056/NEJMoa2502280