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CLOSE 引导下高功率行肺静脉隔离的前瞻性随机评估:POWER-AF 研究。

Prospective Randomized Evaluation of High Power During CLOSE-Guided Pulmonary Vein Isolation: The POWER-AF Study.

机构信息

Department of Cardiology, AZ Sint-Jan Hospital, Bruges (J.-Y.W., M.K., A.A., G.H., T.S., T.P., M.E.H., M.L., J.-B.L.P.d.W., Y.V., R.T., M.D., S.K.).

Department of Cardiology, CHU Saint-Pierre, Université Libre de Bruxelles, Brussels (P.U.).

出版信息

Circ Arrhythm Electrophysiol. 2021 Jan;14(1):e009112. doi: 10.1161/CIRCEP.120.009112. Epub 2020 Dec 10.

DOI:10.1161/CIRCEP.120.009112
PMID:33300809
Abstract

BACKGROUND

CLOSE-guided atrial fibrillation (AF) ablation is based on contiguous (intertag distance ≤6 mm), optimized (Ablation Index >550 anteriorly and >400 posteriorly) point-by-point radiofrequency lesions. The optimal radiofrequency power remains unknown.

METHODS

The POWER-AF study is a prospective, randomized controlled monocentric study including patients with paroxysmal AF, planned for first CLOSE-guided pulmonary vein isolation using a contact force radiofrequency catheter (Thermocool SmartTouch, Biosense Webster, Inc, Irvine, CA). A total of 100 patients were randomized into 2 groups (1:1). The control group received AF ablation using the standard CLOSE protocol (35 W), whereas in the experimental group, pulmonary vein isolation was performed using high power (45 W). Endoscopic evaluation was performed in patients with intraesophageal temperature rise >38.5 °C.

RESULTS

The resulting sample size was 96 (48+48) patients. In the high power group, shorter procedure time (80 versus 102 minutes, <0.001), shorter total radiofrequency application time (16 versus 26 minutes, <0.001), and radiofrequency time per application (26 versus 37 s anteriorly, <0.001 and 13 versus 17 s posteriorly, <0.001) were observed. Endoscopic evaluation (performed in 19/48 versus 25/48 patients respectively, =0.31) showed an ulcerative perforation in a high power group patient (treated by endoscopic stenting and normalization after ≈4 months) and a superficial ulcerative lesion in a control group patient (conservative treatment). Both occurred following excessive Ablation Index applications (up to 460 and 480, respectively) with excessive contact force (30 g on average, with peaks up to 50 g). Six-months AF recurrence was not significantly different (10% in high power versus 8% in control, =0.74).

CONCLUSIONS

This randomized controlled study shows that a 45 W radiofrequency power CLOSE protocol in patients with paroxysmal AF significantly increases the global procedural efficiency with similar midterm efficacy. However, our study showed a narrower safety margin and a limited increased efficiency at the posterior wall using high power. This advocates against the use of high power in the region neighboring the esophagus.

摘要

背景

基于连续(标签间距离≤6 毫米)、优化(消融指数在前部>550,在后部>400)的点对射频消融的 CLOSE 指导心房颤动(AF)消融。最佳射频功率仍不清楚。

方法

POWER-AF 研究是一项前瞻性、随机对照的单中心研究,纳入了阵发性 AF 患者,计划首次使用接触力射频导管(Thermocool SmartTouch,Biosense Webster,Inc,Irvine,CA)进行 CLOSE 指导肺静脉隔离。共 100 例患者随机分为 2 组(1:1)。对照组采用标准 CLOSE 方案(35 W)行 AF 消融,实验组采用高功率(45 W)行肺静脉隔离。食管内温度升高>38.5℃时行内镜评估。

结果

最终样本量为 96 例(48+48)患者。高功率组的手术时间更短(80 分钟比 102 分钟,<0.001),总射频应用时间更短(16 分钟比 26 分钟,<0.001),每个应用的射频时间更短(前部 26 秒比 37 秒,<0.001;后部 13 秒比 17 秒,<0.001)。内镜评估(分别在 19/48 例和 25/48 例患者中进行,=0.31)显示高功率组患者出现溃疡性穿孔(经内镜支架治疗,约 4 个月后恢复正常)和对照组患者出现浅表性溃疡性病变(保守治疗)。两者均发生在消融指数过高(分别为 460 和 480)和接触力过大(平均 30 克,峰值达 50 克)的情况下。6 个月时 AF 复发无显著差异(高功率组 10%,对照组 8%,=0.74)。

结论

这项随机对照研究表明,阵发性 AF 患者采用 45 W 射频功率的 CLOSE 方案可显著提高整体手术效率,且中期疗效相似。然而,我们的研究显示,在后壁使用高功率时,安全性范围更窄,效率提高有限。这不支持在毗邻食管的区域使用高功率。

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