Repeat Procedures After Pulsed Field Ablation for Atrial Fibrillation: MANIFEST-REDO Study.

Abstract

Background: Initial clinical studies of pulsed field ablation (PFA) to treat atrial fibrillation (AF) indicated a >90% durability rate of pulmonary vein isolation (PVI). However, these studies were largely conducted in single centers and involved a limited number of operators. The electrophysiological findings and outcomes in patients undergoing repeat ablation after an initial PF ablation for AF are incompletely understood.

Methods: In the MANIFEST-REDO study, we investigated patients who underwent repeat ablation due to clinical recurrence - AF or atrial tachycardia (AT) - following first-ever PVI with a pentaspline PFA catheter (Farawave; Boston Scientific Inc).

Results: At 22 centers, 427 patients (age 64±11 years; 37% female) were included. Of note, the recurrent arrhythmia leading to the repeat ablation was paroxysmal AF (51%), persistent AF (30%), or AT (19%). At the repeat procedure, the PV reconnection rates were: 30% (LSPV), 28% (LIPV), 33% (RSPV) and 32% (RIPV). In 45% of patients all PVs were durably isolated at the beginning of the repeat procedure, with the previous use of any imaging or mapping modality being univariately associated with durable PVI. After a post-redo follow-up period of 284 [90-366] days, the primary effectiveness endpoint (freedom from documented AF/AT lasting ≥30s after 3-month blanking without class I/III antiarrhythmic drugs or symptoms) was achieved in 65% of patients, with significant differences between groups (PAF 65% vs. PersAF 56% vs. AT 76%; p=0.04). Persistent AF as recurrent arrhythmia after the initial PFA ablation predicted AT/AF recurrence after repeat ablation (HR 1.241 (95% CI 1.534-1.005 CI); p=0.045). The procedural complication rate was 2.8%.

Conclusion: In repeat procedures for AF/AT performed after an index procedure with PFA for AF, PV reconnections are not uncommon. Repeat procedures can be performed safely and with an acceptable subsequent success rate.