Abstract
BACKGROUND: There is no evidence evaluating efficiency, effectiveness, and safety outcomes in older patients in the context of pulsed-field ablation technology for the ablation of atrial fibrillation. We aimed to compare safety, efficacy, and acute and long-term outcomes of pulsed-field ablation in older patients (≥75 years) with younger ones. METHODS: We enrolled consecutive patients who had undergone atrial fibrillation ablation with the pulsed-field ablation FARAPULSE system (Boston Scientific) at 15 centers. Patients were stratified by age (<65, 65-74, and ≥75 years) and efficacy and safety profiles of these groups were compared. RESULTS: A total of 1082 patients were included: 108 (10%) were ≥75 years old, 374 (34.6%) were 65-74 years old and 600 (55.4%) were <65 years old. Older patients displayed a more pronounced risk profile compared with their younger counterparts, characterized by a significant higher burden of comorbidities. No differences in terms of procedural metrics were found. Pulmonary vein isolation was achieved in all patients. An overall low rate of procedural-related complications was reported (3.0%) without difference between young and older patients (P=0.241). During a mean follow-up of 342±111 days, a primary efficacy end point occurred in 605 of 748 (80.9%) patients with available outcome information. The arrhythmia recurrence rate ranged from 14.4% in patients <65 years old to 26.9% of older patients (P=0.011). CONCLUSIONS: Drawing from these findings, using the FARAPULSE system for atrial fibrillation ablation in older patients demonstrated swift, safe, and effective acute outcomes, mirroring a comparable pattern observed in younger patients and recurrence rates in line with the literature in older patients. REGISTRATION: URL: clinicaltrials.gov; Unique Identifier: NCT05617456.