Safety and feasibility of atrial fibrillation ablation using Amigo ® system versus manual approach: A pilot study.

BACKGROUND: The Amigo® Remote Catheter System is a relatively new robotic system for catheter navigation. This study compared feasibility and safety using Amigo (RCM) versus manual catheter manipulation (MCM) to treat paroxysmal atrial fibrillation (PAF). Contact force (CF) and force-time integral (FTI) values obtained during pulmonary vein isolation (PVI) ablation were compared.

METHODS: Forty patients were randomly selected for either RCM (20) or MCM (20). All were studied with the Thermocool® SmartTouch® force-sensing catheter (STc). Contact Force (CF), Force Time Integral (FTI) and procedure-related data, were measured/stored in the CARTO® 3.

RESULTS: All cases achieved complete PVI without major complications. Mean CF was significantly higher in the RCM group (13.3 ± 7.7 g in RCM vs. 12.04 ± 7.42 g in MCM p < 0.001), as was overall mean FTI (425.6 gs ± 199.6 gs with RCM and 407.5 gs ± 288.0 gs in MCM (p = 0.007) and was more likely to fall into the optimal FTI range (400-1000) using RCM (66.1% versus 49.1%, p < 0.001). FTI was significantly more likely to fall within the optimal range in each PV, as was CF within its optimal range in the right PVs, but trended higher in the left PVs. Freedom from atrial tachyarrhythmia was 90.0% for the RCM and 70.0% for the MCM group (p = 0,12) at 540 days follow-up.

CONCLUSIONS: This pilot study suggests that use of the Amigo RCM system, with STc catheter, seems to be safe and effective for PVI ablation in paroxysmal AF patients. A not statistically significant favorable trend was observed for RCM in term of AF-free survival.