Arrhythmias & electrophysiology
Pulsed Field Ablation for Persistent Atrial Fibrillation: 1-Year Results of ADVANTAGE AF
Authors' conclusion
ADVANTAGE AF, the first large prospective study of PFA to treat PerAF using a strategy of PVI and posterior wall isolation, revealed favorable safety and effectiveness outcomes.
Study context
- Population
- Patients with persistent AF (persistent atrial fibrillation (PerAF))260 treatment, 79 roll-in
- Participants
- 339 patients
- Exposure
- Pulmonary vein isolation (PVI) + posterior wall ablation (PWA) with pentaspline pulsed field ablation (PFA) catheter vs predefined performance goals
- PFAn = 339
- Outcome
- Safety: incidence of predefined adverse events; effectiveness: acute success and postblanking freedom from atrial tachyarrhythmia recurrence (>30 seconds), redo ablation, cardioversion or antiarrhythmic drug escalation
- Follow-up
- 1 year
Methodological detailsmulticentre, pivotal investigational device exemption study, 1-year follow-up with 24-hour Holter at 6 and 12 months plus twice-monthly and symptomatic transtelephonic monitoring
- Multicentre
- Pivotal investigational device exemption study
- 1-year follow-up with 24-hour Holter at 6 and 12 months plus twice-monthly and symptomatic transtelephonic monitoring
Main finding
As reported in the abstract
Primary effectiveness and primary safety endpoints
Primary safety endpoint (predefined adverse events)
2.3%
5.1% upper confidence limit
Primary effectiveness
63.5%
57.3% lower confidence limit
Observational data: associations, not effects.
Further findings
Acute success, PVI and PWA
- Success for both PVI and PWA
- 99.7%
Single, isolated AF recurrence
- Patients with a single, isolated AF recurrence
- 8.5%
Freedom from symptomatic AF
- Freedom from symptomatic AF
- 85.3%
- Efficacy varied by operator experience
Safety
Components of the primary safety endpoint
- Pericarditis
- 1
- MI
- 1
- Pulmonary edema
- 4
- No tamponade, stroke, pulmonary vein stenosis or esophageal fistula
Original publication
Pulsed Field Ablation for Persistent Atrial Fibrillation: 1-Year Results of ADVANTAGE AF. J Am Coll Cardiol. Published 6 May 2025. doi:10. 1016/ j. jacc. 2025. 03. 515
Summarised from the published abstract; every number is checked against it