Pulsed field ablation in real-world atrial fibrillation patients: clinical recurrence, operator learning curve and re-do procedural findings.

Abstract

Pulsed field ablation (PFA) is a novel method of cardiac ablation demonstrated in early pre-clinical and clinical settings. The aim of this study was to report the safety and clinical efficacy of pulmonary vein isolation (PVI) with PFA for real-world atrial fibrillation (AF) patients. All-comer AF patients (n = 121, 59% paroxysmal) were prospectively included and underwent PFA with 100% high-density voltage maps performed after PVI. Clinical outcomes were gathered by chart review. PVI was achieved with PFA-only in 119 (98%) of the cases. During the implementation phase the mean procedure and fluoroscopy time was reduced from 85 ± 34 to 72 ± 18min (p = 0.044) and 22 ± 9 to 16 ± 4 (p = 0.034). We observed one phrenic nerve palsy with only partial remission at follow-up. Other adverse events were numerically comparable to standard PVI procedures. Over a mean follow-up of 308 ± 87days, a total of 22/121 (18.2%) cases experienced clinically significant recurrence or initiation of anti-arrhythmic drugs with Kaplan-Meier event-free estimate at 365days of 80% (88% for paroxysmal versus 69% for persistent). In five of eight re-do procedures, gaps were primarily located at the right pulmonary veins. PFA was a highly efficient method to achieve PVI with reductions in procedure time and fluoroscopy over the implementation period. The procedural data and clinical recurrence rates from initial trials were confirmed in real-life non-selected AF patients. More data is needed to establish lesion durability and limitations of PFA.