Cohort study
Safety and Effectiveness of Pulsed Field Ablation to Treat Atrial Fibrillation: One-Year Outcomes From the MANIFEST-PF Registry
- Retrospective multinational patient-level registry
- 24 European centres
- prospective inclusion in centre registries
Authors' conclusion
In this large observational registry of the postapproval clinical use of pulsed field technology to treat AF, catheter ablation using pulsed field energy was clinically effective in 78% of patients with AF.
Study context
- Population
- Patients with atrial fibrillation (AF) undergoing post-approval pulsed field ablation, March 2021–May 2022
- Participants
- 1,568 patients
- Outcome
- Freedom from clinically documented atrial arrhythmia (AF/atrial flutter/atrial tachycardia) ≥30 s on ECG after 3-month blanking (on or off antiarrhythmic drugs)
- Follow-up
- 1 year
Main finding
As reported in the abstract
Freedom from atrial arrhythmia (AF/atrial flutter/atrial tachycardia ≥30 s) after 3-month blanking
1-year Kaplan-Meier estimate for freedom from atrial arrhythmia
78.1% (95% CI, 76.0%-80.0%)
Observational data: associations, not effects.
Further findings
Clinical effectiveness by AF type (subgroup) · 1 year
P = 0.001
Pulmonary vein isolation achieved
- Pulmonary vein isolation achieved
- 99.2%
Safety
Acute major adverse events (<7 days postprocedure)
- Acute major adverse events
- 1.9%
Parts of this Brief are withheld: the automatic checks could not confirm them against the abstract.
Original publication
Safety and Effectiveness of Pulsed Field Ablation to Treat Atrial Fibrillation: One-Year Outcomes From the MANIFEST-PF Registry. Circulation. Published 18 May 2023. doi:10.1161/circulationaha.123.064959
Summarised from the published abstract; every number is checked against it