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脉冲场与高功率短程消融治疗心房颤动的疗效与安全性:一项采用重构事件发生时间数据的系统评价和荟萃分析

Efficacy and Safety of Pulsed-Field Versus High-Power Short-Duration Ablation for Atrial Fibrillation: A Systematic Review and Meta-Analysis With Reconstructed Time-to-Event Data.

作者信息

Amin Ahmed Mazen, Turkmani Mustafa, Al Barznji Saman, Mohanty Sanghamitra, Kaplan Rachel M, Winterfield Jeffrey, Lakkireddy Dhanunjaya, Santangeli Pasquale, Di Biase Luigi, Natale Andrea

机构信息

Faculty of Medicine, Mansoura University, Mansoura, Egypt.

Faculty of Medicine, Michigan State University, Faculty of Medicine, East Lansing, Michigan, USA.

出版信息

J Cardiovasc Electrophysiol. 2025 Aug;36(8):1762-1784. doi: 10.1111/jce.16728. Epub 2025 May 28.

Abstract

BACKGROUND

Pulsed-field ablation (PFA) and high-power short-duration (HPSD) ablation (45-90 W) are emerging technologies in atrial fibrillation (AF) treatment, both achieving durable pulmonary vein isolation. We aim to investigate the efficacy and safety of PFA versus HPSD ablation.

METHODS

We comprehensively searched PubMed, Web of Science (WOS), Scopus, EMBASE, and Cochrane Central Register of Controlled Trials (CENTRAL) through July 2024. Pairwise meta-analysis with reconstructed time-to-event analysis were performed using R version 4.3.1 (PROSPERO ID: CRD42024576031).

RESULTS

Seven observational studies, including 1904 patients, were included. PFA was significantly associated with lower atrial tachyarrhythmia recurrence compared to HPSD ablation (45-90 W) at the longest follow-up (RR: 0.73, 95% CI [0.60, 0.88], p < 0.01). Subgroup analysis revealed a significant reduction in atrial tachyarrhythmia recurrence with PFA versus HPSD ablation (45-50 W) (RR: 0.69, 95% CI [0.54, 0.88], p < 0.01), but not compared to vHPSD ablation (70-90 W). Reconnected pulmonary vein rates were significantly lower with PFA compared to HPSD (45-50 W) (p = 0.03), while no significant difference was observed compared to vHPSD (70-90 W). PFA was significantly associated with reduced procedural duration (MD: -33.15 with 95% CI [-40.93, -25.36], p < 0.01) and left atrial dwell time (MD: -32.16 with 95% CI [-45.55, -18.77], p < 0.01), although fluoroscopy time increased (MD: 7.48 with 95% CI [4.29, 10.68], p < 0.01) compared to HPSD ablation (45-90 W). Safety profiles were comparable, but pericarditis rates were significantly lower with PFA versus HPSD (45-50 W) (p = 0.003) and vHPSD (70-90 W) (p = 0.019). Kaplan-Meier analysis showed a 28% lower risk of atrial tachyarrhythmia recurrence with PFA compared to HPSD ablation (45-90 W) (HR: 0.72, 95% CI [0.57, 0.91], p = 0.006) over an 18-month follow-up.

CONCLUSION

PFA and HPSD ablation (45-90 W) are effective and safe for AF ablation. PFA was significantly associated with lower atrial tachyarrhythmia recurrence, shorter procedural duration, reduced left atrial dwell time, increased fluoroscopy time, and comparable safety, with lower rates of pericarditis compared to HPSD ablation.

摘要

背景

脉冲场消融(PFA)和高功率短程(HPSD)消融(45 - 90W)是心房颤动(AF)治疗中新兴的技术,二者均能实现持久的肺静脉隔离。我们旨在研究PFA与HPSD消融的疗效和安全性。

方法

我们全面检索了截至2024年7月的PubMed、科学网(WOS)、Scopus、EMBASE和Cochrane对照试验中心注册库(CENTRAL)。使用R版本4.3.1进行成对荟萃分析和重建的事件发生时间分析(PROSPERO注册号:CRD42024576031)。

结果

纳入了7项观察性研究,共1904例患者。在最长随访期时,与HPSD消融(45 - 90W)相比,PFA与较低的房性快速性心律失常复发显著相关(RR:0.73,95%CI[0.60,0.88],p < 0.01)。亚组分析显示,与HPSD消融(45 - 50W)相比,PFA使房性快速性心律失常复发显著降低(RR:0.69,95%CI[0.54,0.88],p < 0.01),但与非常高功率短程(vHPSD)消融(70 - 90W)相比无显著差异。与HPSD(45 - 50W)相比,PFA的肺静脉重新连接率显著更低(p = 0.03),而与vHPSD(70 - 90W)相比未观察到显著差异。PFA与手术时间缩短(MD:-33.15,95%CI[-40.93,-25.36],p < 0.01)和左心房停留时间缩短(MD:-32.16,95%CI[-45.55,-18.77],p < 0.01)显著相关,尽管与HPSD消融(45 - 90W)相比透视时间增加(MD:7.48,95%CI[4.29,10.68],p < 0.01)。安全性概况相当,但与HPSD(45 - 50W)(p = 0.003)和vHPSD(70 - 90W)(p = 0.019)相比,PFA的心包炎发生率显著更低。Kaplan - Meier分析显示,在18个月的随访期内,与HPSD消融(45 - 90W)相比,PFA使房性快速性心律失常复发风险降低28%(HR:0.72,95%CI[0.57,0.91],p = 0.006)。

结论

PFA和HPSD消融(45 - 90W)对AF消融有效且安全。与HPSD消融相比,PFA与较低的房性快速性心律失常复发、更短的手术时间、缩短的左心房停留时间、增加的透视时间和相当的安全性显著相关,心包炎发生率更低。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/96dc/12337618/c337e45c1851/JCE-36-1762-g007.jpg

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