Arrhythmias and Conduction Disturbances
Comparison of the Safety and Feasibility of Arrhythmia Ablation Using the Amigo Robotic Remote Catheter System Versus Manual Ablation

https://doi.org/10.1016/j.amjcard.2013.11.030Get rights and content

The aim of this study is to evaluate the safety and feasibility of using the Amigo Remote Catheter System (RCS) in arrhythmia ablation procedures. Because Amigo allows the physician to operate all catheter function outside of the radiation field, operator exposure time was also evaluated. This is a nonrandomized, prospective clinical trial conducted at 1 site (identifier: NCT01834872). The study prospectively enrolled 50 consecutive patients (mean age 59 ± 15 years, 72% men) with any type of arrhythmia (23 atrial fibrillation ablation, 12 common atrial flutters, 10 patients with other supraventricular tachycardia, 4 ventricular tachycardia, and 1 patient with palpitations with no arrhythmia induced) referred for catheter ablation, in which we used RCS. Fifty matched ablation procedures (mean age 57 ± 14 years, 70% men) performed during the same time period, without RCS, were enrolled into the control group. Acute ablation success was 96% with RCS and 98% in the manual group. In only 2 cases, the physician switched to manual ablation (1 ventricular tachycardia and 1 accessory pathway) to complete the procedure. There were no complications related to the use of RCS. No differences were observed in total procedure time, total fluoroscopy time, or total radiofrequency delivery compared with the manual group. In procedures performed with RCS, the operator's fluoroscopy exposure time was reduced by 68 ± 16%. In conclusion, arrhythmia ablation with RCS is safe and feasible. Furthermore, it significantly reduces operator's exposure to radiation.

Section snippets

Methods

The study protocol was approved by the ethical committee and has been registered in ClinicalTrials.gov (identifier: NCT01834872). All patients provided written informed consent before inclusion.

We prospectively enrolled 50 consecutive patients referred to our electrophysiology (EP) laboratory to treat any type of arrhythmia with catheter ablation, in which we used Amigo RCS. All procedures were performed by 2 operators. As a control group, patients were prospectively recruited by matched

Results

Patient characteristics (Table 1) were similar in both groups. Fifty percent of patients in both groups were left-sided procedures. AF was paroxysmal in 13 patients (57%) of RCS group and in 11 controls (47%). There were 4 VTs: 2 idiopathic, 1 with ischemic cardiomyopathy, and 1 with dilated cardiomyopathy (identical in both groups). The type of ablation catheter that was used in each arrhythmia substrate is shown in the Supplementary material. In the RCS group, a Biosense Webster EZ Steer was

Discussion

In the present study, we report for the first time a series of patients with different types of arrhythmias ablated using the new RCS system. Our results show a significant reduction in operator fluoroscopy exposure with this robotic system while maintaining similar acute efficacy and complication rates compared with the conventional approach.

In addition to the Amigo RCS, there are 2 remote navigation systems commercially available for arrhythmia ablation: Niobe magnetic navigation system

Acknowledgment

The authors thank Luiz Pivotto, EE, and Jennifer Englund, BS, BA, for manuscript preparation.

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