Noten Anna Maria Elisabeth, Géczy Tamas, Yap Sing-Chien, Kis Zsuzsanna, Szili-Torok Tamas
Department of Cardiology, Thoraxcenter, Erasmus MC, Rotterdam, The Netherlands.
Heart Rhythm O2. 2020 May 11;1(2):103-110. doi: 10.1016/j.hroo.2020.04.003. eCollection 2020 Jun.
The quality of catheter-tissue contact is one of the most important determinants of catheter ablation (CA) success. The absence of catheter-tissue contact feedback has been regarded a major limitation of remote magnetic navigation (RMN)-guided CA. The e-Contact module (ECM) is a novel feature designed for RMN that measures the quality of catheter-tissue contact.
The purpose of this study was to describe the first clinical experience with this feature and to test its effect on procedural parameters and interference with other ablation equipment during CA procedures as well as its safety.
This was a prospective, single-center, 2-phase study investigating ECM use during complex RMN procedures in 30 patients. Impact of ECM on procedural parameters was evaluated in the feasibility phase (FP), and its interference with other equipment was tested in the interference phase (IP) using pacing maneuvers at 3 randomly selected right atrial sites. Intracardiac electrograms were evaluated for disturbances by 2 independent electrophysiologists.
For FP, mean procedural time was 162 ± 66 minutes, fluoroscopy time 21 ± 9 minutes, and ablation time 34 ± 21 minutes. For IP, no significant differences in pacing capture or thresholds were found (ECM- vs ECM+: site 1: 2.05 vs 2.21 mA; = .320; site 2: 2.15 vs 2.12 mA; = .873; site 3: 2.51 vs 2.50 mA; = .976). Electrogram disturbances did not significantly differ between ECM- and ECM+. No adverse events were reported.
The ECM is a novel catheter-tissue contact technology designed for RMN-guided CA. Our study suggests that this feature is feasible and does not interfere with other electrophysiology equipment while maintaining an excellent safety profile.
导管与组织的接触质量是导管消融(CA)成功的最重要决定因素之一。缺乏导管与组织接触反馈被认为是远程磁导航(RMN)引导下CA的一个主要限制。电子接触模块(ECM)是为RMN设计的一项新功能,用于测量导管与组织的接触质量。
本研究旨在描述使用该功能的首次临床经验,并测试其在CA手术过程中对手术参数的影响、对其他消融设备的干扰及其安全性。
这是一项前瞻性、单中心、两阶段研究,调查了30例患者在复杂RMN手术中使用ECM的情况。在可行性阶段(FP)评估ECM对手术参数的影响,并在干扰阶段(IP)使用在3个随机选择的右心房部位进行起搏操作来测试其对其他设备的干扰。由2名独立的电生理学家评估心内电图的干扰情况。
对于FP,平均手术时间为162±66分钟,透视时间为21±9分钟,消融时间为34±21分钟。对于IP,起搏夺获或阈值未发现显著差异(ECM-与ECM+:部位1:2.05与2.21 mA;P = 0.320;部位2:2.15与2.12 mA;P = 0.873;部位3:2.51与2.50 mA;P = 0.976)。ECM-和ECM+之间的心电干扰无显著差异。未报告不良事件。
ECM是一种为RMN引导下CA设计的新型导管与组织接触技术。我们的研究表明,该功能是可行的,在保持良好安全性的同时不会干扰其他电生理设备。