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高功率短持续时间射频应用实现更快更安全的肺静脉隔离:POWER-FAST III试验

High-Power Short-Duration Radiofrequency Application for Faster and Safer Pulmonary Vein Isolation: The POWER-FAST III Trial.

作者信息

Castrejón-Castrejón Sergio, Martínez Cossiani Marcel, Basterra Sola Nuria, Romero Roldán Javier David, Ibáñez Criado José Luis, Osca Joaquín, Roca-Luque Ivo, Moya Angel, Quesada Aurelio, Hidalgo Olivares Víctor Manuel, Pérez Castellano Nicasio, Fernández-Gómez Juan Manuel, Macías-Ruiz Rosa, Villanueva Bruno Bochard, Gonzalo Bada Nerea, Froilán Torres Consuelo, Sanz Verdejo Beatriz, Sánchez Somonte Paula, Escobar Cervantes Carlos, Moreno Raúl, Merino José Luis

机构信息

Arrhythmia and Robotic EP Unit, Cardiology Department, Hospital Universitario La Paz, IdiPAZ, Madrid, Spain.

Cardiology Department, Hospital Universitario de Navarra, Instituto de Investigación Sanitaria de Navarra, Pamplona, Spain.

出版信息

JACC Clin Electrophysiol. 2025 Feb;11(2):350-361. doi: 10.1016/j.jacep.2024.10.009. Epub 2024 Dec 18.

Abstract

BACKGROUND

The optimal radiofrequency application (RFa) parameters for safe and durable pulmonary vein isolation (PVI) are debated. High-power short-duration (HPSD) has been used as an alternative to conventional power delivery (CPD).

OBJECTIVES

This study sought to compare HPSD 70 W/9-10 s (HPSD-70) with CPD 25-40 W in patients undergoing PVI.

METHODS

Patients were randomized to HPSD-70 or CPD (25-40). The primary outcomes were freedom from atrial arrhythmia recurrences and the incidence of esophageal thermal lesions (EDELs) after ablation.

RESULTS

Among 304 patients randomized, 301 remained in the study (median age: 61 years; Q1-Q3: 53-69 years; 72% men): 294 patients (97.7%) underwent ablation, 285 (94.7%) underwent endoscopy, and 290 (98.6%) completed the follow-up. At 12 months, 100 patients (73.5%) in the CPD (25-40) group and 87 patients (67%) in the HPSD-70 group were free from recurrences off antiarrhythmic drugs (HR: 1.28; 95% CI: 0.82-1.99; P = 0.28). The incidences of EDELs were 2.7% in the CPD (25-40) group and 3.6% in the HPSD-70 group (P = 0.94). Median left atrial dwell (153 vs 137 min; P = 0.03) and total RF times for definitive PVI (31 vs 11.2 min; P < 0.001) were shorter with HPSD-70 ablation. Four symptomatic embolic events (2 strokes, 1 transient ischemic attack, and 1 splenic infarct) occurred with HPSD-70 and none with CPD (25-40) RFa (P = 0.056).

CONCLUSIONS

HPSD-70 RFa was noninferior to prevent arrhythmia recurrences, and the incidence of EDELs was similar compared with CPD (25-40) RFa. The embolic events were numerically higher in the HPSD-70 group. (High Radiofrequency Power for Faster and Safer Pulmonary Vein Ablation Trial [POWER FAST III]; NCT04153747).

摘要

背景

安全且持久的肺静脉隔离(PVI)的最佳射频应用(RFa)参数存在争议。高功率短持续时间(HPSD)已被用作传统功率输送(CPD)的替代方法。

目的

本研究旨在比较接受PVI的患者中HPSD 70W/9 - 10秒(HPSD - 70)与CPD 25 - 40W的情况。

方法

患者被随机分为HPSD - 70组或CPD组(25 - 40)。主要结局是消融后无房性心律失常复发以及食管热损伤(EDELs)的发生率。

结果

在随机分组的304例患者中,301例仍留在研究中(中位年龄:61岁;第一四分位数 - 第三四分位数:53 - 69岁;72%为男性):294例患者(97.7%)接受了消融,285例(94.7%)接受了内镜检查,290例(98.6%)完成了随访。在12个月时,CPD(25 - 40)组的100例患者(73.5%)和HPSD - 70组的87例患者(67%)在停用抗心律失常药物后无复发(风险比:1.28;95%置信区间:0.82 - 1.99;P = 0.28)。CPD(25 - 40)组EDELs的发生率为2.7%,HPSD - 70组为3.6%(P = 0.94)。HPSD - 70消融的左心房中位停留时间(153对137分钟;P = 0.03)和确定性PVI的总射频时间(31对11.2分钟;P < 0.001)较短。HPSD - 70组发生了4例有症状的栓塞事件(2例中风、1例短暂性脑缺血发作和1例脾梗死),CPD(25 - 40)RFa组无此类事件发生(P = 0.056)。

结论

HPSD - 70 RFa在预防心律失常复发方面不劣于CPD(25 - 40)RFa,且EDELs的发生率相似。HPSD - 70组的栓塞事件在数量上更高。(高射频功率实现更快更安全的肺静脉消融试验[POWER FAST III];NCT04153747)

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