168-06: Manual versus Robotic Catheter Ablation for the Treatment of Atrial Fibrillation: The Man and Machine Trial

摘要

Introduction: Circumferential pulmonary vein isolation (CPVI) using irrigated radiofrequency (RF) is the most frequently used ablation technique for the treatment of atrial fibrillation (AF) worldwide. To date, no large randomized multicenter trials have evaluated the efficacy and safety of CPVI using robotic navigation (RN) systems compared to to the current gold standard of manual ablation. Purpose of the study: To compare the efficacy and safety of atrial fibrillation (AF) ablation using a robotic navigation (RN) system compared to manual ablation. Methods: In this prospective, international multicenter non-inferiority trial, 258 patients with paroxysmal or persistent AF were randomized for CPVI using either RN (RN-group, n = 131) or manual ablation (MN-group, n = 127). In all patients, CPVI was performed using irrigated RF ablation in combination with a 3D mapping system. The primary endpoint was the absence of atrial arrhythmia recurrence during a 12-month follow-up (FU) period. Secondary endpoints were evaluation of periprocedural complications and procedural data such as procedure time, fluoroscopy time, and incidence of esophageal injury (EI). Results: Baseline characteristics were comparable between the RN-group and MN-group. Procedure time was significantly shorter in the MN-group (129.3 ± 43.1 min vs 140.9 ± 36.5 min; p = 0.026). 247 patients completed the 12-month FU (RN-group n = 123, MN-group n = 124). Recurrence rate was comparable between the RN-group and MN-group (n = 29/123 (23.6%) vs 25/124 (20.2%). Procedure-related complications rate was also similar (RN-group n = 8 (6.1%) vs MN-group n = 6 (4.7%); p = 0.62). One patient from the RN-group developed a fatal atrio-esophageal fistula. Conclusion: Robotic ablation has been shown to be non-inferior to to the current gold standard of manual ablation for CPVI with respect to success and complication rates. Procedure times were significantly longer in the RN-group.