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采用新型简化方案的心房颤动脉冲场消融:PFA剂量研究

Pulsed field ablation for atrial fibrillation with a novel simplified protocol: The PFA dose study.

作者信息

Badertscher Patrick, Isenegger Corinne, Arnet Rebecca, Jordan Fabian, Knecht Sven, Krisai Philipp, Völlmin Gian, du Fay de Lavallaz Jeanne, Katic Josip, Spreen David, Osswald Stefan, Sticherling Christian, Kühne Michael

机构信息

Department of Cardiology, University Hospital Basel, Basel, Switzerland; Cardiovascular Research Institute Basel, University Hospital Basel, Basel, Switzerland.

Department of Cardiology, University Hospital Basel, Basel, Switzerland; Cardiovascular Research Institute Basel, University Hospital Basel, Basel, Switzerland.

出版信息

Heart Rhythm. 2025 Jun;22(6):1375-1383. doi: 10.1016/j.hrthm.2024.11.031. Epub 2024 Nov 22.

DOI:10.1016/j.hrthm.2024.11.031
PMID:39581429
Abstract

BACKGROUND

Pulsed field ablation (PFA) with use of a pentaspline catheter for the treatment of atrial fibrillation is performed in a standardized fashion. Whether a reduced number of applications results in similar clinical outcomes has not been fully investigated.

OBJECTIVE

This study aimed to assess a simplified PFA dosing protocol for pulmonary vein isolation (PVI) compared with a standard protocol.

METHODS

Consecutive patients undergoing their first PVI by PFA were enrolled. In the simple PFA group, patients received 4 applications per pulmonary vein (2× basket and 2× flower configuration), whereas 8 applications per pulmonary vein (4× basket and 4× flower configuration) were used in the standard PFA group.

RESULTS

We included 245 patients (32% female; median age, 66 years), 96 (39%) in the simple PFA group and 149 (61%) in the standard PFA group. Median procedure duration, left atrial dwell time, and fluoroscopy time were significantly shorter in the simple PFA group compared with the standard PFA group at 40 (25-55) minutes vs 53 (41-67) minutes (P < .001), 22 (13-37) minutes vs 37 (27-50) minutes (P < .001), and 9 (7-12) minutes vs 11 (9-14) minutes (P < .001), respectively. First-pass isolation was similar for the simple PFA group and the standard PFA group (95% vs 95%; P > .999). Overall, 4 procedural complications were observed, all in the standard PFA group (P = .303). During a median follow-up of 373 days, freedom from atrial arrhythmias was 79% in the simple PFA group and 77% in the standard PFA group (P = .767). Findings were confirmed in comparing only patients who received PVI with or without electroanatomic mapping.

CONCLUSION

The novel simplified PFA protocol was associated with increased procedural efficiency while maintaining noninferior efficacy and safety compared with the standard PFA protocol.

摘要

背景

使用五叶形导管进行脉冲场消融(PFA)治疗心房颤动是按照标准化方式进行的。应用次数减少是否会产生相似的临床结果尚未得到充分研究。

目的

本研究旨在评估一种简化的PFA给药方案用于肺静脉隔离(PVI)并与标准方案进行比较。

方法

纳入首次接受PFA进行PVI的连续患者。在简化PFA组中,患者每条肺静脉接受4次应用(2次篮状配置和2次花状配置),而标准PFA组每条肺静脉使用8次应用(4次篮状配置和4次花状配置)。

结果

我们纳入了245例患者(女性占32%;中位年龄66岁),简化PFA组96例(39%),标准PFA组149例(61%)。与标准PFA组相比,简化PFA组的中位手术持续时间、左心房停留时间和透视时间显著更短,分别为40(25 - 55)分钟对53(41 - 67)分钟(P <.001),22(13 - 37)分钟对37(27 - 50)分钟(P <.001),以及9(7 - 12)分钟对11(9 - 14)分钟(P <.001)。简化PFA组和标准PFA组的首次通过隔离相似(95%对95%;P >.999)。总体而言,观察到4例手术并发症,均在标准PFA组(P =.303)。在中位随访373天期间,简化PFA组无房性心律失常的比例为79%,标准PFA组为77%(P =.767)。在仅比较接受或未接受电解剖标测的PVI患者时,结果得到证实。

结论

与标准PFA方案相比,新的简化PFA方案在保持疗效和安全性不劣的同时提高了手术效率。

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