Randomized trial comparing robotic to manual ablation for atrial fibrillation

Abstract

Background: Catheter ablation of atrial fibrillation (AF) is a physically demanding procedure for the operator, involving radiation exposure, and has limited success rates. Remote robotic navigation (RRN) may offer benefit to the procedure, though only 1 previous small randomized trial has assessed this.

Objective: This study aimed to investigate the impact of RRN on 1-year single-procedure success rates.

Methods: RRN was compared to manual ablation in a randomized control trial setting by using an intention-to-treat analysis.

Results: A total of 157 patients underwent ablation (116/157 (74%) persistent AF; 67/116 (58%) of these long-standing persistent AF). There were no significant differences between the RRN and manual groups with respect to 1-year single-procedure success rates (19/78 (24%) and 26/78 (33%), respectively; P = .29), acute wide area circumferential ablation reconnection rates, complication rates, or procedure times. On multivariable analysis, fluoroscopy times were significantly shorter in the RRN group. The number of catheter displacements during ablation was lower in the RRN group, as was subjectively assessed operator fatigue. The crossover rate from RRN to manual ablation was 11/78 (14%), mainly secondary to technical problems with the RRN system. A learning curve was evident for RRN ablation: the fluoroscopy and procedure times were significantly lower after the first 10 cases in an operator's experience.

Conclusion: This randomized trial showed no difference in the success rate for catheter ablation of AF between a RRN and manual approach. The results highlight the learning curve for RRN ablation and suggest that the use of this technology leads to an improvement in fluoroscopy times, catheter stability, and operator fatigue.

Keywords: Atrial fibrillation; Catheter ablation; Manual ablation; Randomized controlled trial; Remote robotic navigation.