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使用机器人导航系统分析心房颤动消融术中的导管接触力:一项随机研究的结果

Analysis of catheter contact force during atrial fibrillation ablation using the robotic navigation system: results from a randomized study.

作者信息

Dello Russo Antonio, Fassini Gaetano, Conti Sergio, Casella Michela, Di Monaco Antonio, Russo Eleonora, Riva Stefania, Moltrasio Massimo, Tundo Fabrizio, De Martino Giuseppe, Gallinghouse G Joseph, Di Biase Luigi, Natale Andrea, Tondo Claudio

机构信息

Cardiac Arrhythmia Research Center, Centro Cardiologico Monzino IRCCS, Via Carlo Parea 4, 20138, Milan, Italy.

Catholic University of Sacred Heart, Rome, Italy.

出版信息

J Interv Card Electrophysiol. 2016 Aug;46(2):97-103. doi: 10.1007/s10840-016-0102-0. Epub 2016 Jan 21.

Abstract

PURPOSE

Contact with cardiac tissue is an important determinant of lesion efficacy during atrial fibrillation (AF) ablation. The Sensei X™ robotic navigation system (RNS) (Hansen Medical, Mountain View, CA, USA) has been validated for contact force (CF) sensing expressed in grams (g). The Thermocool® SmartTouch™ catheter enables the measurement of catheter tip CF and direction inside the heart. We aimed to investigate the catheter CF with and without RNS during pulmonary vein isolation (PVI) procedures.

METHODS

Eighty patients with symptomatic AF (56 males, age 63 ± 18) were enrolled in this study. Fifty-seven patients had paroxysmal AF and 23 early persistent AF. All procedures were performed with the Thermocool® SmartTouch™ ablation catheter. Forty patients were randomized to perform PVI with the Sensei X™ RNS (group 1), while in the other 40 patients (group 2), PVI was performed without the RNS.

RESULTS

AF ablation was performed successfully in all patients without complications, while contact force was kept in the established 10-40 g range. A significantly higher CF was documented on the PVs in group 1 compared to group 2. The 1-year freedom from AF recurrence was higher in group 1 compared to group 2 (90 vs. 65 %, p = 0.04). Moreover, a significant reduction of fluoroscopy time was noted in the RNS group (13 ± 10 vs. 20 ± 10 min, respectively, p = 0.05).

CONCLUSIONS

The Sensei X™ RNS permits a significantly higher CF during transcatheter AF ablation with a low rate of AF recurrence at clinical follow-up.

摘要

目的

在心房颤动(AF)消融过程中,与心脏组织的接触是决定消融效果的重要因素。Sensei X™ 机器人导航系统(RNS)(美国加利福尼亚州山景城的汉森医疗公司)已被证实可用于以克(g)为单位表示的接触力(CF)传感。Thermocool® SmartTouch™ 导管能够测量导管尖端在心脏内的CF和方向。我们旨在研究在肺静脉隔离(PVI)手术中使用和不使用RNS时的导管CF。

方法

本研究纳入了80例有症状的AF患者(56例男性,年龄63±18岁)。57例患者为阵发性AF,23例为早期持续性AF。所有手术均使用Thermocool® SmartTouch™ 消融导管进行。40例患者被随机分配使用Sensei X™ RNS进行PVI(第1组),而在另外40例患者(第2组)中,PVI在不使用RNS的情况下进行。

结果

所有患者的AF消融均成功完成,无并发症发生,同时接触力保持在既定的10 - 40 g范围内。与第2组相比,第1组在肺静脉上记录到的CF显著更高。第1组的1年无AF复发率高于第2组(90%对65%,p = 0.04)。此外,RNS组的透视时间显著减少(分别为13±10分钟和20±10分钟,p = 0.05)。

结论

Sensei X™ RNS在经导管AF消融过程中允许显著更高的CF,临床随访时AF复发率较低。

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