Pulsed Field Ablation of Persistent Atrial Fibrillation With Continuous Electrocardiographic Monitoring Follow-Up:...

Area of Science:

• Cardiology
• Electrophysiology
• Medical Devices

Background:

• Limited safety and effectiveness data exist for pulsed field ablation (PFA) in persistent atrial fibrillation (PerAF), especially for lesions beyond pulmonary vein isolation (PVI).
• No large trials have utilized insertable cardiac monitors (ICMs) for continuous rhythm monitoring post-ablation in PerAF patients or any atrial fibrillation (AF) population undergoing PFA.
• The ADVANTAGE AF-Phase 2 study investigated PFA for PVI and posterior wall ablation (PWA) in PerAF patients, with a sub-cohort receiving cavotricuspid isthmus (CTI) ablation.

Purpose of the Study:

• To evaluate the safety and effectiveness of PFA for PVI and PWA in PerAF patients.
• To assess the safety and effectiveness of PFA for CTI ablation in a sub-cohort of PerAF patients.
• To examine atrial arrhythmia (AA) burden and episode duration using ICMs for continuous rhythm monitoring post-ablation.

Main Methods:

• PerAF patients underwent PVI and PWA using a pentaspline PFA catheter, and CTI ablation with a focal-linear PFA catheter, with intravenous nitroglycerin (NTG) prophylaxis.
• Patients were monitored for 1 year using ICMs for continuous rhythm monitoring to assess the primary efficacy endpoint and analyze AA burden and episode duration.
• The study aimed to emulate traditional intermittent monitoring for the primary endpoint while also examining detailed rhythm data.

Main Results:

• The study included 255 PerAF patients; PVI and PWA achieved 99.6% and 100% acute success, respectively. CTI PFA was performed in 141 patients (55.3%), achieving 98.6% bidirectional block without complications.
• Using traditional monitoring emulation, freedom from AA was 73.4% with 2.4% adverse events. Freedom from recurrent atrial flutter was 97.2%.
• Continuous ICM data showed 52.0% freedom from AA ≥30 seconds, with 94.0% of episodes not exceeding 24 hours. An AA burden >0.1% or longest episode duration >1 hour predicted increased healthcare utilization. One-year procedural effectiveness was 71.6% and 70.0% based on these thresholds.

Conclusions:

• CTI ablation with NTG prophylaxis was safe and effective in the ADVANTAGE AF-Phase 2 study.
• PVI + PWA using PFA was also demonstrated to be safe and effective in PerAF patients.
• An AA burden <0.1% and AA episode duration <1 hour were identified as endpoints associated with the lowest healthcare utilization.