Introduction: Currently, numerous ablation techniques are available for atrial fibrillation (AF), in addition to manual radio frequency ablation. The aim of this prospective, non-randomized concurrent controlled trial was to compare the mid-term efficacy and procedural outcomes of persistent AF (PerAF) using cryoballoon (CB) and robotic magnetic navigation (RMN). Methods: Two hundred PerAF patients were assigned, in a 1:1 ratio, to undergo catheter ablation using RMN (RMN group) or CB (CB group). The primary endpoint was freedom from AF recurrence following a 3-month period after the index ablation. The secondary endpoint was peri-procedural outcomes, including the total procedure time, left atrial procedure time, fluoroscopy time, and fluoroscopy dose. The Two-step cluster analysis was used to determine the efficacy of RMN and CB between the different groups. The Cox proportional hazard model and restricted cubic spline were used to determine predictors for AF recurrence. Results: At the mean follow-up of 28.1 ± 9.7 months, the primary endpoint was achieved in 71 PerAF patients in the RMN group and in 62 PerAF patients in the CB group (71% vs. 62%, p = 0.158). Compared with CB, RMN-guided ablation led to a longer procedure time (p < 0.001), but with less radiation (p < 0.001). Cluster analysis returned two clusters of patients and RMN was favorable for one cluster (p = 0.037), in which more patients presented with diabetes mellitus and smaller left atria. Conclusions: For patients with PerAF, CB is generally equivalent to RMN-guided ablation with regard to overall efficacy. RMN-guided ablation could be favorable in specific patient populations presenting with diabetes mellitus and smaller left atria.
Keywords: atrial fibrillation; catheter ablation; cryoballoon; robotic magnetic navigation.