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

J Interv Card Electrophysiol. 2016 Nov;47(2):213-219. doi: 10.1007/s10840-016-0140-7. Epub 2016 May 26.

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.

Keywords: Atrial fibrillation; Catheter ablation; Multi-electrode ablation catheter; Phased RF.

Publication types

  • Controlled Clinical Trial

MeSH terms

  • Atrial Fibrillation / diagnosis*
  • Atrial Fibrillation / surgery*
  • Body Surface Potential Mapping / instrumentation*
  • Catheter Ablation / instrumentation*
  • Equipment Design
  • Equipment Failure Analysis
  • Female
  • Follow-Up Studies
  • Humans
  • Longitudinal Studies
  • Male
  • Middle Aged
  • Pilot Projects
  • Recurrence
  • Reproducibility of Results
  • Sensitivity and Specificity
  • Surgery, Computer-Assisted / instrumentation*
  • Treatment Outcome