Pulsed field ablation in real-life atrial fibrillation patients: 1-year clinical recurrence, operator learning curve and re-do procedural findings

Abstract

Abstract Funding Acknowledgements Type of funding sources: None. Pulsed field ablation (PFA) is a novel method of cardiac ablation demonstrated in early preclinical 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. Methods and results All-comer AF patients (n=121, 59% paroxysmal) were prospectively included and underwent PFA with 100% HD voltage maps performed after PVI. 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 ± 18 minutes (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 ± 87 days 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 365 days of 80% (88% for paroxysmal versus 69% for persistent) Figure 1. HD mapping post-PVI showed insufficient acute lesion formation in up to 20% (60% of these right sided) resulting in additional PFA for sufficient isolation. In four of six re-do procedures significant gaps were located at the right pulmonary veins. Conclusion PFA was a highly efficient method to achieve PVI with reductions in procedure time and fluoroscopy over the implementation period. The safety, procedural data and clinical recurrence rates from initial trials were confirmed in real-life non-selected AF patients. More data is needed to investigate and understand the lesion durability and limitations of PFA.