Department of Cardiology, Heart and Diabetes Center North Rhine-Westfalia, Ruhr University Bochum, Bad Oeynhausen, Germany.
Europace. 2012 Dec;14(12):1715-8. doi: 10.1093/europace/eus169. Epub 2012 Jun 20.
Studies have shown that remote magnetic navigation is safe and effective for ablation of atrial arrhythmias, although optimal outcomes often require frequent manual manipulation of a circular mapping catheter. The Vdrive robotic system ('Vdrive') was designed for remote navigation of circular mapping catheters to enable a fully remote procedure. This study details the first human clinical experience with remote circular catheter manipulation in the left atrium.
This was a prospective, multi-centre, non-randomized consecutive case series that included patients presenting for catheter ablation of left atrial arrhythmias. Remote systems were used exclusively to manipulate both the circular mapping catheter and the ablation catheter. Patients were followed through hospital discharge. Ninety-four patients were included in the study, including 23 with paroxysmal atrial fibrillation (AF), 48 with persistent AF, and 15 suffering from atrial tachycardias. The population was predominately male (77%) with a mean age of 60.5 ± 11.7 years. The Vdrive was used for remote navigation between veins, creation of chamber maps, and gap identification with segmental isolation. The intended acute clinical endpoints were achieved in 100% of patients. Mean case time was 225.9 ± 70.5 min. Three patients (3.2%) crossed over to manual circular mapping catheter navigation. There were no adverse events related to the use of the remote manipulation system.
The results of this study demonstrate that remote manipulation of a circular mapping catheter in the ablation of atrial arrhythmias is feasible and safe. Prospective randomized studies are needed to prove efficiency improvements over manual techniques.
研究表明,远程磁导航对于心房心律失常的消融是安全有效的,尽管优化的结果通常需要频繁地手动操作环形标测导管。Vdrive 机器人系统(“Vdrive”)旨在远程导航环形标测导管,以实现完全远程手术。本研究详细介绍了在左心房中首次进行远程环形导管操作的人体临床经验。
这是一项前瞻性、多中心、非随机连续病例系列研究,纳入了因左心房心律失常而接受导管消融治疗的患者。远程系统专门用于操纵环形标测导管和消融导管。患者在出院后进行随访。本研究共纳入 94 例患者,其中阵发性心房颤动(AF)23 例,持续性 AF48 例,房性心动过速 15 例。患者主要为男性(77%),平均年龄为 60.5±11.7 岁。Vdrive 用于远程导航静脉、创建腔室图和进行节段性隔离的间隙识别。主要的急性临床终点在 100%的患者中达到。平均手术时间为 225.9±70.5 分钟。3 例(3.2%)患者转为手动环形标测导管导航。没有与远程操作系统使用相关的不良事件。
本研究结果表明,在心房心律失常的消融中远程操作环形标测导管是可行且安全的。需要前瞻性随机研究来证明与手动技术相比的效率提高。