First results and follow-up of a second-generation circular mapping and ablation catheter

Abstract

Purpose: Pulmonary vein isolation with radiofrequency energy is widely used as a strategy for catheter ablation of atrial fibrillation (AF). Anatomically designed catheters have been developed to increase the efficiency of AF ablation procedures. The second-generation circular ablation catheter, PVAC GOLD, was re-designed to improve energy delivery and mitigate emboli. We investigated the procedural efficiency, biophysics, and chronic efficacy of PVAC GOLD in patients with AF. Methods: We consecutively enrolled 40 patients (60 ± 11 years) with highly symptomatic, drug refractory AF. The first 20 patients were treated with the first-generation PVAC. The subsequent 20 patients were treated with the second-generation PVAC GOLD catheter. All patients were followed up at 3, 6, and 12 months. Results: All 164 targeted PVs were successfully isolated. Ablations performed with PVAC GOLD showed a significant reduction in total number of ablations needed for PVI, fluoroscopy, and procedure times compared to PVAC (34.7 ± 7.0 vs. 27.0 ± 6.5; p = 0.009), fluoroscopy (29.5 ± 9.5 vs. 23.4 ± 7.0; p = 0.026), and procedure time (93.8 ± 18.9 vs. 83.1 ± 10.6; p = 0.033). PVAC GOLD showed improved biophysics including a reduction of low power ablations and an increase in mean effective energy delivery. At 12 months follow-up, AF recurrence rates were comparable in the two groups (35 vs. 30 %; p = 0.735). There were no adverse events. Conclusions: The redesigned PVAC GOLD catheter demonstrates a reduction in radiofrequency ablation and procedure time and improved biophysics while maintaining chronic efficacy compared to the first-generation PVAC.