Multi-national survey on the methods, efficacy, and safety on the post-approval clinical use of pulsed field ablation (MANIFEST-PF)
Why the study?
Real-world performance, acute effectiveness, and safety—particularly rare oesophageal effects and unforeseen complications—of the only approved pulsed field ablation catheter needed evaluation after initial clinical trials.
Does pulsed field ablation improve acute efficacy and safety in patients with atrial fibrillation?
Population
1758 patients undergoing AF ablation across 24 clinical centres
Comparison
Pentaspline pulsed field ablation catheter clinical use
Design
Retrospective multicentre survey
Authors
Discussion
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Member takes
Implication
Real-world PFA use shows favorable acute safety without esophageal injury; leaves open confirmation of efficacy and durability in randomized trials.
Structured PICO
Does pulsed field ablation improve acute efficacy and safety in patients with atrial fibrillation?
P
Population
1758 patients undergoing atrial fibrillation ablation, mean age 61.6 years, 34% female, 94% first-time ablation, 58% paroxysmal AF, 35% persistent AF.
I
Intervention
Pulsed field ablation (PFA) using the pentaspline PFA catheter
O
Outcome
Acute effectiveness (pulmonary vein isolation success) and safety (oesophageal effects, phrenic nerve injuries, and other complications)safety
In a large real-world cohort, pulsed field ablation for atrial fibrillation demonstrated high acute efficacy for pulmonary vein isolation and no oesophageal damage, though generic catheter complications like tamponade and stroke still occurred.
Cite This Study
Ekanem et al. (2022) studied this question.