Does extent of lesion set using pulsed field ablation impact the safety of de novo ablation procedures? Sub-analysis of the FARADISE registry

Abstract Background Atrial fibrillation (AF) ablation studies have demonstrated conflicting results on the optimal ablation strategy. The most widely used strategy is pulmonary vein isolation (PVI). However, many consider additional targets critical to managing AF. To date, limited evidence exists with pulsed field ablation (PFA) comparing clinical outcomes in AF patients treated with a varying lesion set. Purpose Characterize the real-world use of PFA to treat AF through using a PVI-only strategy versus PVI plus additional ablation (PVI+). Methods FARADISE is a prospective, non-randomized, global registry (NCT05501873) that enrolled subjects clinically indicated for an ablation procedure using the pentaspline PFA catheter per medical judgement and hospital standard-of-care. Patient demographics and procedural characteristics, including lesion sets, were collected for each subject. Those with a PVI-only procedure were compared to those receiving PVI+. Follow-up, up to 3 years post-ablation, is currently ongoing. Results Out of the 1173 subjects enrolled in the registry, 1045 (89%) were de novo AF ablation cases. PVI-only was performed in 802 cases and PVI+ in 243 cases. Overall, the patients receiving PVI+ were older, more often had persistent AF, had a lower left ventricular ejection fraction and larger left atrial diameter (Table). Procedures performing extra-PV ablation had significantly longer procedure times (70.8±24.7 vs 51.1±20.4 min; p<0.01) and fluoroscopy times (17.0±8.6 vs 12.5±7.8 min; p<0.01). There was no difference in the rate of procedure- or device-related serious adverse events based on the lesion sets delivered [PVI-only: 10 (1.2%) vs PVI+: 5 (2.1%), p=0.31]. Conclusion In a real-world registry, 77% of de novo ablation procedures using the pentaspline PFA catheter were PVI-only. Including additional ablation targets resulted in longer procedure times but didn’t impact the observed safety profile compared to PVI-only procedures. The long-term follow-up is ongoing and will help us better understand chronic implications of PFA lesion sets to treat AF.Patient Characteristics