Safety and Effectiveness of Pulsed Field Ablation to Treat Atrial Fibrillation: One-Year Outcomes From the MANIFEST-PF Registry
Language English Country United States Media print-electronic
Document type Journal Article, Research Support, Non-U.S. Gov't
- Keywords
- atrial fibrillation, catheter ablation, irreversible electroporation therapy, treatment outcome,
- MeSH
- Atrial Fibrillation * diagnosis surgery drug therapy MeSH
- Atrial Flutter * etiology MeSH
- Ventricular Function, Left MeSH
- Catheter Ablation * adverse effects methods MeSH
- Middle Aged MeSH
- Humans MeSH
- Recurrence MeSH
- Registries MeSH
- Retrospective Studies MeSH
- Aged MeSH
- Stroke Volume MeSH
- Pulmonary Veins * MeSH
- Treatment Outcome MeSH
- Check Tag
- Middle Aged MeSH
- Humans MeSH
- Aged MeSH
- Female MeSH
- Publication type
- Journal Article MeSH
- Research Support, Non-U.S. Gov't MeSH
BACKGROUND: Pulsed field ablation is a novel nonthermal cardiac ablation modality using ultra-rapid electrical pulses to cause cell death by a mechanism of irreversible electroporation. Unlike the traditional ablation energy sources, pulsed field ablation has demonstrated significant preferentiality to myocardial tissue ablation, and thus avoids certain thermally mediated complications. However, its safety and effectiveness remain unknown in usual clinical care. METHODS: MANIFEST-PF (Multi-National Survey on the Methods, Efficacy, and Safety on the Post-Approval Clinical Use of Pulsed Field Ablation) is a retrospective, multinational, patient-level registry wherein patients at each center were prospectively included in their respective center registries. The registry included all patients undergoing postapproval treatment with a multielectrode 5-spline pulsed field ablation catheter to treat atrial fibrillation (AF) between March 1, 2021, and May 30, 2022. The primary effectiveness outcome was freedom from clinical documented atrial arrhythmia (AF/atrial flutter/atrial tachycardia) of ≥30 seconds on the basis of electrocardiographic data after a 3-month blanking period (on or off antiarrhythmic drugs). Safety outcomes included the composite of acute (<7 days postprocedure) and latent (>7 days) major adverse events. RESULTS: At 24 European centers (77 operators) pulsed field ablation was performed in 1568 patients with AF: age 64.5±11.5 years, female 35%, paroxysmal/persistent AF 65%/32%, CHA2DS2-VASc 2.2±1.6, median left ventricular ejection fraction 60%, and left atrial diameter 42 mm. Pulmonary vein isolation was achieved in 99.2% of patients. After a median (interquartile range) follow-up of 367 (289-421) days, the 1-year Kaplan-Meier estimate for freedom from atrial arrhythmia was 78.1% (95% CI, 76.0%-80.0%); clinical effectiveness was more common in patients with paroxysmal AF versus persistent AF (81.6% versus 71.5%; P=0.001). Acute major adverse events occurred in 1.9% of patients. CONCLUSIONS: 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.
Asklepios Hospital St Georg Hamburg Germany
Cardiology Department Na Homolce Hospital Homolka Hospital Prague Czechia
Copenhagen University Hospital Denmark
Department for Cardiovascular Diseases University Hospital Center Split Croatia
Department of Cardiology Catharina Ziekenhuis Eindhoven The Netherlands
Department of Cardiology Jessa Hospitals Hasselt Belgium
Department of Cardiology Rouen Hospital France
Department of Cardiology University Hospital Rangueil Toulouse France
Department of Cardiology University of Groningen University Medical Center Groningen The Netherlands
Department of Electrophysiology Alfried Krupp Hospital Essen Germany
Department of Medicine Witten Herdecke University Germany
German Center for Cardiovascular Research
Heart Center Bad Neustadt Rhoen Clinic Campus Bad Neustadt Bad Neustadt an der Saale Germany
Heart Center University Hospital of Cologne Department for Electrophysiology Germany
Heart Rhythm Department Clinique Pasteur Toulouse France
I2MC INSERM UMR 1297 Toulouse France
Icahn School of Medicine at Mount Sinai New York NY
IHU LIRYC CHU Bordeaux University of Bordeaux France
IKEM Institute for Clinical and Experimental Medicine Prague Czech Republic
Inselspital Bern University Hospital University of Bern Switzerland
Medical University of Graz Austria
MVZ CCB Frankfurt und Main Taunus GbR Frankfurt Germany
Neuron Medical Brno Czech Republic
Universitair Ziekenhuis VUB Brussels Belgium
University Heart and Vascular Center University Medical Center Hamburg Eppendorf Germany
References provided by Crossref.org
Coronary Artery Spasm During Pulsed Field vs Radiofrequency Catheter Ablation of the Mitral Isthmus
Clinical Outcomes by Sex After Pulsed Field Ablation of Atrial Fibrillation
