MAP-AF:一项多中心、单盲、随机对照试验。

IF 9.1 1区 医学 Q1 CARDIAC & CARDIOVASCULAR SYSTEMS
Yoshihide Takahashi, Atsushi Kobori, Kenichi Hiroshima, Yuichiro Sakamoto, Masaomi Kimura, Osamu Inaba, Kojiro Tanimoto, Ryoichi Hanazawa, Akihiro Hirakawa, Masahiko Goya, Tetsuo Sasano
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引用次数: 0

摘要

背景:肺静脉隔离术(PVI)治疗持续性房颤(AF)的临床效果并不理想。制图研究表明,房颤期间肺静脉以外的心房部位显示局灶性激活模式。我们试图确定在 PVI 的基础上增加病灶激活部位的导管消融是否能改善持续性房颤导管消融的临床疗效:在这项多中心、随机、单盲试验中,我们按 1:1 的比例将持续性房颤患者分配给单纯 PVI 或在 PVI 基础上在映射引导下对病灶激活点进行消融。在映射引导组,使用 Pentaray 导管(Biosense-Webster)在 PVI 后对两个心房进行映射,并对 CARTOFINDER(Biosense-Webster)确定的病灶激活点进行消融。主要终点是在 90 天空白期后无需服用抗心律失常药物即可摆脱房颤或房性心动过速:共有 98 名患者被分配到映射引导组,102 名患者被分配到单纯 PVI 组。在映射引导组中,每位患者在左心房和右心房分别发现了 2.6±0.3 和 2.5±0.2 个局灶激活点。映射引导消融组和单纯 PVI 组患者的随访时间分别为 768.5 天(四分位数间距,723.75-915.75)和 755.5 天(四分位数间距,728.5-913.75)。映射引导消融组和单纯 PVI 组患者在随访 2 年时无需服用抗心律失常药物即可摆脱房颤/房性心动过速的比例分别为 66.8% 和 75.2%(危险比为 1.26 [95% CI, 0.76-2.10];P=0.37)。映射引导消融组和单纯 PVI 组分别有 3 名患者(3.0%)和 0 名患者(0%)发生不良事件(P=0.12):结论:在持续性房颤患者中,与单纯PVI相比,在PVI基础上对病灶激活点进行映射引导消融并不能改善临床预后:URL: https://center6.umin.ac.jp/cgi-open-bin/ctr/index.cgi?function=02; Unique gidentifier:UMIN000037569。
本文章由计算机程序翻译,如有差异,请以英文原文为准。
Mapping-Guided Ablation for Persistent Atrial Fibrillation (MAP-AF): A Multicenter, Single-Blind, Randomized Controlled Trial.

Background: The clinical outcome of pulmonary vein isolation (PVI) for persistent atrial fibrillation (AF) is suboptimal. Mapping studies have demonstrated atrial sites outside of the pulmonary veins displaying focal activation patterns during AF. We sought to determine whether adding catheter ablation of focal activation sites to PVI improves clinical outcomes of catheter ablation for persistent AF.

Methods: In this multicenter, randomized, single-blinded trial, we assigned patients with persistent AF to either PVI alone or to mapping-guided ablation of focal activation sites in addition to PVI in a 1:1 ratio. In the mapping-guided group, both atria were mapped after PVI using a Pentaray catheter (Biosense-Webster) and focal activation sites identified by CARTOFINDER (Biosense-Webster) were ablated. The primary end point was freedom from AF or atrial tachycardia without antiarrhythmic drugs beyond a 90-day blanking period.

Results: A total of 98 patients were assigned to the mapping-guided group and 102 to the PVI alone group. In the mapping-guided group, focal activation sites were identified at 2.6±0.3 and 2.5±0.2 sites per patient in the left and right atrium, respectively. Patients were followed up for 768.5 (interquartile range, 723.75-915.75) and 755.5 days (interquartile range, 728.5-913.75) in the mapping-guided ablation and the PVI alone groups, respectively. Freedom from AF/atrial tachycardia without antiarrhythmic drugs at 2-year follow-up was 66.8% and 75.2% in the mapping-guided ablation and the PVI alone groups, respectively (hazard ratio, 1.26 [95% CI, 0.76-2.10]; P=0.37). Adverse events occurred in 3 patients (3.0%) and none (0%) in the mapping-guided ablation and the PVI alone groups, respectively (P=0.12).

Conclusions: In patients with persistent AF, the addition of mapping-guided ablation of focal activation sites to PVI did not improve clinical outcomes compared with PVI alone.

Registration: URL: https://center6.umin.ac.jp/cgi-open-bin/ctr/index.cgi?function=02; Unique identifier: UMIN000037569.

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来源期刊
CiteScore
13.70
自引率
4.80%
发文量
187
审稿时长
4-8 weeks
期刊介绍: Circulation: Arrhythmia and Electrophysiology is a journal dedicated to the study and application of clinical cardiac electrophysiology. It covers a wide range of topics including the diagnosis and treatment of cardiac arrhythmias, as well as research in this field. The journal accepts various types of studies, including observational research, clinical trials, epidemiological studies, and advancements in translational research.
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