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接触力感应消融持续性心房颤动:一项随机、多中心试验。

Contact force sensing for ablation of persistent atrial fibrillation: A randomized, multicenter trial.

机构信息

Southlake Regional Health Centre, Newmarket, Ontario, Canada.

Hollywood Private Hospital, Nedlands, Perth, Australia.

出版信息

Heart Rhythm. 2018 Feb;15(2):201-208. doi: 10.1016/j.hrthm.2017.10.010. Epub 2017 Oct 10.

DOI:10.1016/j.hrthm.2017.10.010
PMID:29030237
Abstract

BACKGROUND

Impact of contact force sensing (CFS) on ablation of persistent atrial fibrillation (PeAF) is unknown.

OBJECTIVE

The purpose of the TOUCH AF (Therapeutic Outcomes Using Contact force Handling during Ablation of Persistent Atrial Fibrillation) randomized trial was to compare CFS-guided ablation to a CFS-blinded strategy.

METHODS

Patients (n = 128) undergoing first-time ablation for persistent AF were randomized to a CFS-guided vs CFS-blinded strategy. In the CFS-guided procedure, operators visualized real-time force data. In the blinded procedure, force data were hidden. Wide antral pulmonary vein isolation plus a roof line were performed. Patients were followed at 3, 6, 9, and 12 months with clinical visit, ECG, and 48-hour Holter monitoring. The primary endpoint was cumulative radiofrequency (RF) time for all procedures. Atrial arrhythmia >30 seconds after 3 months was a recurrence.

RESULTS

PeAF was continuous for 26 weeks (interquartile range [IQR] 13-52), and left atrial size was 45 ± 5 mm. Force in the CFS-blinded and CFS-guided arms was 12 g [IQR 6-20] and 14 g [IQR 9-20] (P = .10), respectively. Total RF time did not differ between CFS-guided and CFS-blinded groups (49 ± 14 min vs 50 ± 20 min, respectively; P = .70). Single procedure freedom from atrial arrhythmia was 60% in the CFS-guided arm and 63% in the CFS-blinded arm off drugs. Lesions with gaps were associated with significantly less force (11.4 g [IQR 6-19] vs 13.2 g [IQR 8-20], respectively; P = .0007) and less force-time integral (174 gs [IQR 91-330] vs 210 gs [IQR 113-388], respectively; P <.001).

CONCLUSION

CFS-guided ablation resulted in no difference to RF time or 12-month outcome. Lower force/force-time integral was associated with significantly more gaps.

摘要

背景

接触力感应(CFS)对持续性心房颤动(PeAF)消融的影响尚不清楚。

目的

TOUCH AF(使用接触力处理消融持续性心房颤动的治疗结果)随机试验的目的是比较 CFS 引导消融与 CFS 盲法策略。

方法

128 例首次接受持续性 AF 消融的患者被随机分为 CFS 引导组与 CFS 盲法组。在 CFS 引导程序中,操作人员实时观察力数据。在盲法程序中,力数据被隐藏。进行广泛的肺静脉前庭隔离加房顶线。患者在 3、6、9 和 12 个月时通过临床访视、心电图和 48 小时 Holter 监测进行随访。主要终点是所有程序的累积射频(RF)时间。3 个月后 30 秒以上的房性心律失常为复发。

结果

PeAF 持续 26 周(四分位间距[IQR]13-52),左心房大小为 45±5mm。CFS 盲法组和 CFS 引导组的力分别为 12g(IQR6-20)和 14g(IQR9-20)(P=0.10)。CFS 引导组和 CFS 盲法组的总 RF 时间无差异(分别为 49±14min 和 50±20min,P=0.70)。CFS 引导组和 CFS 盲法组停药后单次手术房性心律失常无复发率分别为 60%和 63%。存在间隙的病灶与力显著降低相关(分别为 11.4g(IQR6-19)和 13.2g(IQR8-20),P=0.0007),力时间积分显著降低(分别为 174gs(IQR91-330)和 210gs(IQR113-388),P<0.001)。

结论

CFS 引导消融与 RF 时间或 12 个月的结果无差异。较低的力/力时间积分与显著更多的间隙相关。

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