A PROSPECTIVE, MULTICENTER COHORT STUDY COMPARING PHASED MULTIPOLAR VERSUS TRADITIONAL RADIOFREQUENCY ABLATION

Abstract

Percutaneous catheter ablation has emerged as an effective therapeutic method for Atrial Fibrillation as the most common arrhythmia. Multipolar, phased radiofrequency (RF) catheter ablation (PVAC) has been shown to have comparable efficacy, and reduced fluoroscopy and procedural times compared to traditional RF. These studies have been small, therefore, we performed this multicenter cohort study in order to assess the efficacy and efficiency (procedural time and safety) of using this catheter for ablation in patients with highly symptomatic paroxysmal AF (PAF). This is a multicenter, sequential, prospective, cohort study between 2012 to 2016 in 6 tertiary care centers. The protocol of the study was registered on Clinicaltrials.gov website (NCT01562912). Patients were enrolled if they had symptomatic, paroxysmal AF (less than 7 days) refractory to at least one antiarrhythmic medication. A total of 230 patients were enrolled in a 2:1 ratio of PVAC (group A) to control (group B). Ablations were performed by the same operators. ECG and 48 hour Holter monitor were used to assess patients at 3, 6, 9 and 12 months post-ablation follow up. Recurrence was defined as any atrial arrhythmia >30 seconds. The primary endpoint was PVAC efficiency combining procedural time, efficacy, and repeat procedures. Intention to treat analysis was utilized for this study. Overall, 230 patients consisted of 162 males (70.4%) with mean age 57 ± 11 years were analyzed. Recurrence post ablation was 73.2% (101) and 58.9% (43) in groups A, and B respectively (p=0.034). Three, 6, 9, and 12-month recurrence for Group A versus B were 56.7% vs 49.3%, (p=0.31), 48.3% vs. 29.9%, (p=0.013), 44.3% vs 30.6, (p=0.07), and 35.2% vs 29.4%, (p=0.42) respectively. Among these patients, 14.7% (21) in group A and 7.7% (6) in group B had redo procedure (p=0.12). Procedure time was significantly lower in Group A than Group B (190.2±39.9 vs. 230±50.38 minutes, P < 0.0001). There was not any significant difference in fluoroscopy time between the two groups (p=0.49). Mean survival from recurrence for group A and B at 12 months was 26.8% vs 41.1% respectively (p=0.051). There were no significant differences in adverse events between the two groups in 12-month follow-up (P=0.16). This study demonstrated that PVAC catheter can significantly reduce procedure time for PVAI procedure, however, it may increase the likelihood of further recurrence of atrial tachyarrhythmia.