Arrhythmias & electrophysiologyCohort study
Pulsed Field Ablation for Persistent Atrial Fibrillation
- Prospective single-arm study
- 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
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
Main finding
As reported in the abstract
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
Summarised from the published abstract; every number is checked against it