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接触力监测与单极信号修正在房颤导管消融中的比较:前瞻性多中心随机研究。

Comparison Between Contact Force Monitoring and Unipolar Signal Modification as a Guide for Catheter Ablation of Atrial Fibrillation: Prospective Multi-Center Randomized Study.

机构信息

Department of Cardiology, Tokyo Women's Medical University, Japan (K.E., M.S., N.H.).

Department of Cardiology, Tokyo Metropolitan Tama Medical Center, Japan (K.K.).

出版信息

Circ Arrhythm Electrophysiol. 2019 Aug;12(8):e007311. doi: 10.1161/CIRCEP.119.007311. Epub 2019 Jul 26.

DOI:10.1161/CIRCEP.119.007311
PMID:31345092
Abstract

BACKGROUND

Both contact force monitoring (CFM) and unipolar signal modification (USM) are guides for ablation, which improve the efficacy of pulmonary vein isolation of atrial fibrillation. We sought to compare the outcomes of atrial fibrillation ablation guided by CFM or USM.

METHODS

A total of 136 patients with paroxysmal atrial fibrillation underwent a circumferential pulmonary vein isolation using CF sensing ablation catheters and were randomly assigned to undergo catheter ablation guided by either CFM (CFM-guided group: n=70) or USM (USM-guided group: n=66). In the USM-guided group, each radiofrequency application lasted until the development of completely positive unipolar electrograms. In the CFM-guided group, a CF of 20 g (range, 10-30 g) and minimum force-time integral of 400 g were the targets for each radiofrequency application. The primary end point was freedom from any atrial tachyarrhythmia recurrence without antiarrhythmic drugs at 12-months of follow-up.

RESULTS

The cumulative freedom from recurrences at 12-months was 85% in the USM-guided group and 70% in the CFM-guided group (P=0.031). The incidence of time-dependent and ATP-provoked early electrical reconnections between the left atrium and PVs, procedural time, fluoroscopic time, and average force-time integral, did not significantly differ between the 2 groups. The radiofrequency time for the pulmonary vein isolation was shorter in the USM-guided group than CFM-guided group but was not statistically significant (P=0.077).

CONCLUSIONS

USM was superior to CFM as an end point for radiofrequency energy deliveries during the pulmonary vein isolation in patients with paroxysmal atrial fibrillation in terms of the 12-month recurrence-free rate.

CLINICAL TRIAL REGISTRATION

URL: https://www.umin.ac.jp/ctr/index.htm. Unique identifier: UMIN000021127.

摘要

背景

接触力监测(CFM)和单极信号修正(USM)都是指导消融的方法,可提高心房颤动肺静脉隔离的疗效。我们旨在比较 CFM 或 USM 指导下的房颤消融结果。

方法

共 136 例阵发性心房颤动患者接受环肺静脉隔离,采用 CFM 感测消融导管,并随机分为 CFM 指导(CFM 指导组:n=70)或 USM 指导(USM 指导组:n=66)下的导管消融。在 USM 指导组中,每次射频应用持续到完全阳性单极电图的发展。在 CFM 指导组中,每次射频应用的目标是接触力为 20 g(范围,10-30 g)和最小力-时间积分 400 g。主要终点是在 12 个月随访时无任何抗心律失常药物的复发性房性心动过速。

结果

USM 指导组 12 个月时的无复发生存率为 85%,CFM 指导组为 70%(P=0.031)。左心房与 PV 之间的时间依赖性和 ATP 诱发的早期电连接、手术时间、透视时间和平均力-时间积分的发生率在两组间无显著差异。USM 指导组的肺静脉隔离射频时间短于 CFM 指导组,但无统计学意义(P=0.077)。

结论

在阵发性心房颤动患者中,与 CFM 相比,USM 作为射频能量输送的终点,在肺静脉隔离 12 个月时无复发生存率更高。

临床试验注册

网址:https://www.umin.ac.jp/ctr/index.htm。独特识别码:UMIN000021127。

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