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.
Does Agmedse Impact Safety and Efficacy During Pulse-Field Ablation for Atrial Fibrillation? / A. Dello Russo, C. Tondo, S. Bianchi, V. Schillaci, S. Iacopino, M. Casella, A. Rossillo, R. Maggio, S. Themistoclakis, M. Bertini, M. Russo, M. Volpicelli, G. Viola, R. Rordorf, M. Schiavone, Y. Valeri, J. Colella, P. Rossi, F. Tundo, G. Zingarini, A. De Simone, L. Bianchini, A. Di Vilio, P. Compagnucci, M. Malacrida, G. Zucchelli, F. Solimene. - In: JOURNAL OF THE AMERICAN HEART ASSOCIATION. CARDIOVASCULAR AND CEREBROVASCULAR DISEASE. - ISSN 2047-9980. - 14:9(2025 May 06), pp. e037959.1-e037959.11. [10.1161/JAHA.124.037959]
Does Agmedse Impact Safety and Efficacy During Pulse-Field Ablation for Atrial Fibrillation?
C. TondoSecondo
;S. Bianchi;M. Schiavone;F. Tundo;L. Bianchini;
2025
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.File | Dimensione | Formato | |
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