Background: Multipolar, phased radiofrequency (RF) catheter ablation (PVAC) has been associated with reduced procedural times compared to traditional RF. We performed a multicenter study to assess the efficacy and efficiency of using this catheter.
Methods: This is a multicenter, sequential, prospective, cohort study between 2012 to 2016 in 6 tertiary care centers (NCT01562912). Patients were enrolled if they had symptomatic, paroxysmal AF (less than 7 days) refractory to at least one antiarrhythmic medication. Patients were enrolled in a 2:1 ratio of PVAC (group A) to control point-by-point RF with 3D mapping (group B). 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 excluding an initial 3 month blanking period.
Results: Overall, 230 patients consisting of 162 males (70.4%) with mean age 57±11 years were analyzed. By Kaplan-Meier analysis, freedom from any atrial arrhythmia at 12 months was 49% and 69.2% in group A and B respectively (p=0.033) (Figure1). Among patients with recurrence, 14.7% (21) in group A and 7.7% (6) in group B had redo procedure within 12 month post procedure(p=0.12). Procedure time was significantly lower in Group A than Group B (P<0.0001). There was no significant difference in fluoroscopy time between the two groups (p=0.49). Stroke was not reported in any of the patients. Pulmonary Embolism, occurred in 1.3% of patients in group B. Pericardial effusion occurred in 1.4% in group A and 2.6% in group B. Tamponade occurred in 3.8% of patients in group B.
Conclusion: This study demonstrated that the PVAC catheter is associated with significantly reduced procedure times for AF ablation, however, AF recurrence rates may be higher than contemporary point-by-point RF ablation with 3D mapping technology.