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Safety and Effectiveness of Pulsed Field Ablation to Treat Atrial Fibrillation: One-Year Outcomes From the MANIFEST-PF Registry

MK. Turagam, P. Neuzil, B. Schmidt, T. Reichlin, K. Neven, A. Metzner, J. Hansen, Y. Blaauw, P. Maury, T. Arentz, P. Sommer, A. Anic, F. Anselme, S. Boveda, T. Deneke, S. Willems, P. van der Voort, R. Tilz, M. Funasako, D. Scherr, R. Wakili, D....

Circulation (New York, N.Y.). 2023 ; 148 (1) : 35-46. [pub] 20230518

Circulation (New York)
ISSN 1524-4539
Medvik
Zdroj

Jazyk angličtina Země Spojené státy americké

Typ dokumentu časopisecké články, práce podpořená grantem

Perzistentní odkaz https://www.medvik.cz/link/bmc23016932

Online Plný text

NLK Free Medical Journals od 1950 do Před 1 rokem
Open Access Digital Library od 1950-01-01
Open Access Digital Library od 1950-01-01

PubMed 37199171
DOI 10.1161/circulationaha.123.064959
Knihovny.cz E-zdroje

MeSH
fibrilace síní * diagnóza chirurgie farmakoterapie MeSH
flutter síní * etiologie MeSH
funkce levé komory srdeční MeSH
katetrizační ablace * škodlivé účinky metody MeSH
lidé středního věku MeSH
lidé MeSH
recidiva MeSH
registrace MeSH
retrospektivní studie MeSH
senioři MeSH
tepový objem MeSH
venae pulmonales * MeSH
výsledek terapie MeSH
Check Tag
lidé středního věku MeSH
lidé MeSH
senioři MeSH
ženské pohlaví MeSH
Publikační typ
časopisecké články MeSH
práce podpořená grantem 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

Clinic for Electrophysiology Herz und Diabeteszentrum NRW Ruhr University Bochum Bad Oeynhausen Germany

Copenhagen University Hospital Denmark

Department for Cardiovascular Diseases University Hospital Center Split Croatia

Department of Cardiology and Angiology Medical Center and Faculty of Medicine University of Freiburg Germany

Department of Cardiology and Vascular Medicine West German Heart and Vascular Center Essen University Duisburg Essen Germany

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

Department of Pulmonology Gastroenterology and Internal Medicine Alfried Krupp Hospital Essen 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

University Heart Center Lübeck Department of Rhythmology University Hospital Schleswig Holstein Germany

Citace poskytuje Crossref.org

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