Pulsed field ablation for pulmonary vein isolation and additional lesion set in patients with persistent atrial fibrillation: safety, efficacy and long-term outcome from a nationwide experience

Abstract Background Evidence on the use of pulsed-field ablation (PFA) in patients with persistent atrial fibrillation (PsAF) undergoing lesion sets beyond pulmonary vein isolation (PVI) is limited. Purpose To evaluate the safety and efficacy of PFA in PsAF patients when ablation extends beyond the PVI to include other left atrial (LA) structures, such as ablation of the LA posterior wall ablation or roof, in a large, nationwide clinical setting. Methods The ATHENA prospective registry enrolled consecutive PsAF patients undergoing catheter ablation with the pentaspline Farapulse PFA system across 19 Italian centers. Procedures were categorized as standard protocol-directed PVI (STD) or PVI with additional lesions outside PVs (i.e. left atrial posterior wall) at the operator’s discretion (EXTD). Results Among 574 patients (mean age 64 ± 9 years, 20% female, 27.4% with long-standing PsAF), 330 (57.5%) underwent EXTD ablation and 244 (42.5%) underwent STD ablation. Baseline characteristics were comparable between groups, except for left ventricular ejection fraction (EXTD vs STD: 53.7 ± 9% vs 55.1 ± 10%, p=0.015) and history of repeat ablation (22.1% vs 13.9%, p=0.013). Use of 3D mapping (44.2% vs 17.2%, p0.001) and intracardiac echocardiography (37.6% vs 13.1%, p0.001) was more frequent in EXTD procedures. PFA deliveries around the PVs (32 32–40 vs 32 32–40, p=0.733) and fluoroscopy times (18 14–24 vs 17 13–23 min, p=0.124) were similar, while procedure duration was longer in EXTD cases (78 65–95 vs 70 58–98 min, p0.001). In the EXTD group, a median of 18 14–26 additional lesions were delivered. After a 60-day blanking period, over a median follow-up of 366 240–399 days, AF recurrence occurred in 129 patients (22.5%), and any atrial arrhythmia recurrence in 152 (26.5%). EXTD ablation was associated with lower recurrence compared with STD: 18.8% vs 27.5% for AF, with an HR of 0.70 (95%CI: 0.49–0.99, p=0.04) and 22.4% vs 32.0% for any atrial arrhythmia, with an HR of 0.72 (95%CI: 0.52–0.99, p=0.039). Major complications occurred in 4 patients (0.7%), with no difference between groups (0.6% vs 0.8%, p=1.00). No clinically relevant hemolysis, stroke, pericarditis or acute ST-T change was observed. Conclusion In this nationwide registry, PFA for PsAF was safe and effective. Extending the lesion set beyond PVI was associated with improved rhythm outcomes without increasing complications.