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持续性心房颤动中,在肺静脉隔离基础上额外进行ExTRa标测引导下基质消融的疗效:ROTATE试验

Efficacy of additional ExTRa Mapping-guided substrate ablation beyond pulmonary vein isolation in persistent atrial fibrillation: The ROTATE trial.

作者信息

Kawaji Tetsuma, Aizawa Takanori, Shizuta Satoshi, Yamano Saki, Naka Misaki, Bao Bingyuan, Hojo Shun, Matsuda Shintaro, Kato Masashi, Yokomatsu Takafumi, Miki Shinji

机构信息

Department of Cardiology, Mitsubishi Kyoto Hospital, Kyoto.

Department of Cardiovascular Medicine, Graduate School of Medicine, Kyoto University, Kyoto.

出版信息

J Cardiovasc Electrophysiol. 2025 Aug;36(8):1999-2010. doi: 10.1111/jce.16772. Epub 2025 Jun 23.

DOI:10.1111/jce.16772
PMID:40548679
原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC12337631/
Abstract

INTRODUCTION

There are currently no established effective additional substrate ablation strategies beyond pulmonary vein isolation (PVI) for persistent atrial fibrillation (AF).

OBJECTIVE

This randomized clinical trial evaluated the efficacy of a novel substrate ablation technique using the ExTRa Mapping system, which visualizes rotational activation during AF rhythm.

METHODS

This study included 80 patients undergoing initial catheter ablation for persistent AF. Eighty patients whose AF persisted after PVI and ExTRa Mapping were randomly assigned in a 1:1 ratio to either PVI alone or PVI plus ExTRa Mapping-guided substrate ablation targeting areas with high non-passively activated ratio(%NP)( ≥ 35%)(ExTRa group). The primary outcome measure was recurrence of atrial tachyarrhythmias after a 90-day blanking period postablation.

RESULTS

Post-PVI ExTRa Mapping assessed a median of 36 sites per patient in both atria. Baseline characteristics were comparable between groups. The ExTRa group showed higher event-free survival from the primary outcome compared to the PVI alone group (85.0% vs. 67.5% at 1-year, p = 0.07). This favorable prognosis was more pronounced for patients with a large( ≥ 12 sites) area of rotational activation area (81.0% vs. 57.9% at 1-year, p = 0.01). Multivariable analysis identified the number of high %NP areas as an independent risk factor for recurrent tachyarrhythmias (HR 1.13, 95%CI 1.03-1.23, p = 0.005), while ExTRa Mapping-guided substrate ablation emerged as a unique protective factor (HR 0.38, 95%CI 0.13-0.99, p = 0.047).

CONCLUSION

While the reduction in atrial tachyarrhythmia recurrence of persistent AF patients did not reach statistical significance, the addition of ExTRa Mapping™-guided substrate ablation beyond PVI demonstrated promising potential, especially in patients with larger rotational activation areas.

摘要

引言

目前,除肺静脉隔离(PVI)外,尚无已确立的针对持续性心房颤动(AF)的有效附加基质消融策略。

目的

这项随机临床试验评估了使用ExTRa Mapping系统的新型基质消融技术的疗效,该系统可在房颤心律期间可视化旋转激活。

方法

本研究纳入了80例接受初次导管消融治疗持续性房颤的患者。80例在PVI和ExTRa Mapping后仍持续房颤的患者按1:1比例随机分为单纯PVI组或PVI加ExTRa Mapping引导的基质消融组,后者针对非被动激活率(%NP)高(≥35%)的区域(ExTRa组)。主要结局指标是消融后90天空白期后房性快速心律失常的复发情况。

结果

PVI后ExTRa Mapping评估每名患者双侧心房的中位部位数为36个。两组间基线特征具有可比性。与单纯PVI组相比,ExTRa组从主要结局来看无事件生存率更高(1年时为85.0%对67.5%,p = 0.07)。对于旋转激活区域面积大(≥12个部位)的患者,这种良好预后更为明显(1年时为81.0%对57.9%,p = 0.01)。多变量分析确定高%NP区域的数量是复发性快速心律失常的独立危险因素(HR 1.13,95%CI 1.03 - 1.23,p = 0.005),而ExTRa Mapping引导的基质消融则是唯一的保护因素(HR 0.38,95%CI 0.13 - 0.99,p = 0.047)。

结论

虽然持续性房颤患者房性快速心律失常复发率的降低未达到统计学意义,但在PVI基础上加用ExTRa Mapping™引导的基质消融显示出有前景的潜力,尤其是在旋转激活区域较大的患者中。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/ab12/12337631/3761eea1409f/JCE-36-1999-g004.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/ab12/12337631/d22e84aec35a/JCE-36-1999-g003.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/ab12/12337631/ae41bce39542/JCE-36-1999-g001.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/ab12/12337631/a5f41e3a0e1e/JCE-36-1999-g002.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/ab12/12337631/3761eea1409f/JCE-36-1999-g004.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/ab12/12337631/d22e84aec35a/JCE-36-1999-g003.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/ab12/12337631/ae41bce39542/JCE-36-1999-g001.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/ab12/12337631/a5f41e3a0e1e/JCE-36-1999-g002.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/ab12/12337631/3761eea1409f/JCE-36-1999-g004.jpg

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