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Clinical Outcomes by Sex After Pulsed Field Ablation of Atrial Fibrillation
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....
Jazyk angličtina Země Spojené státy americké
Typ dokumentu časopisecké články, komentáře
- MeSH
- fibrilace síní * farmakoterapie MeSH
- kohortové studie MeSH
- lidé středního věku MeSH
- lidé MeSH
- mladiství MeSH
- retrospektivní studie MeSH
- senioři MeSH
- sexuální faktory MeSH
- výsledek terapie MeSH
- Check Tag
- lidé středního věku MeSH
- lidé MeSH
- mladiství MeSH
- mužské pohlaví MeSH
- senioři MeSH
- ženské pohlaví MeSH
- Publikační typ
- časopisecké články MeSH
- komentáře MeSH
IMPORTANCE: Previous studies evaluating the association of patient sex with clinical outcomes using conventional thermal ablative modalities for atrial fibrillation (AF) such as radiofrequency or cryoablation are controversial due to mixed results. Pulsed field ablation (PFA) is a novel AF ablation energy modality that has demonstrated preferential myocardial tissue ablation with a unique safety profile. OBJECTIVE: To compare sex differences in patients undergoing PFA for AF in the Multinational Survey on the Methods, Efficacy, and Safety on the Postapproval Clinical Use of Pulsed Field Ablation (MANIFEST-PF) registry. DESIGN, SETTING, AND PARTICIPANTS: This was a retrospective cohort study of MANIFEST-PF registry data, which included consecutive patients undergoing postregulatory approval treatment with PFA to treat AF between March 2021 and May 2022 with a median follow-up of 1 year. MANIFEST-PF is a multinational, retrospectively analyzed, prospectively enrolled patient-level registry including 24 European centers. The study included all consecutive registry patients (age ≥18 years) who underwent first-ever PFA for paroxysmal or persistent AF. EXPOSURE: PFA was performed on patients with AF. All patients underwent pulmonary vein isolation and additional ablation, which was performed at the discretion of the operator. MAIN OUTCOMES AND MEASURES: The primary effectiveness outcome was freedom from clinically documented atrial arrhythmia for 30 seconds or longer after a 3-month blanking period. The primary safety outcome was the composite of acute (<7 days postprocedure) and chronic (>7 days) major adverse events (MAEs). RESULTS: Of 1568 patients (mean [SD] age, 64.5 [11.5] years; 1015 male [64.7%]) with AF who underwent PFA, female patients, as compared with male patients, were older (mean [SD] age, 68 [10] years vs 62 [12] years; P < .001), had more paroxysmal AF (70.2% [388 of 553] vs 62.4% [633 of 1015]; P = .002) but had fewer comorbidities such as coronary disease (9% [38 of 553] vs 15.9% [129 of 1015]; P < .001), heart failure (10.5% [58 of 553] vs 16.6% [168 of 1015]; P = .001), and sleep apnea (4.7% [18 of 553] vs 11.7% [84 of 1015]; P < .001). Pulmonary vein isolation was performed in 99.8% of female (552 of 553) and 98.9% of male (1004 of 1015; P = .90) patients. Additional ablation was performed in 22.4% of female (124 of 553) and 23.1% of male (235 of 1015; P = .79) patients. The 1-year Kaplan-Meier estimate for freedom from atrial arrhythmia was similar in male and female patients (79.0%; 95% CI, 76.3%-81.5% vs 76.3%; 95% CI, 72.5%-79.8%; P = .28). There was also no significant difference in acute major AEs between groups (male, 1.5% [16 of 1015] vs female, 2.5% [14 of 553]; P = .19). CONCLUSION AND RELEVANCE: Results of this cohort study suggest that after PFA for AF, there were no significant sex differences in clinical effectiveness or safety events.
Asklepios Hospital St Georg Hamburg Germany
Cardiology Department Na Homolce Hospital Homolka Hospital Prague Czechia
Department for Cardiovascular Diseases University Hospital Center Split Split Croatia
Department of Cardiology Herlev Gentofte University Hospital Hellerup Denmark
Department of Cardiology Jessa Hospitals Hasselt Belgium
Department of Cardiology Rouen Hospital Rouen France
Department of Cardiology University Hospital Rangueil Toulouse France
Department of Electrophysiology Alfried Krupp Hospital Essen Germany
Department of Medicine Witten Herdecke University Witten Germany
Division of Cardiology Department of Internal Medicine Medical University of Graz Graz Austria
German Center for Cardiovascular Research Partner Site Hamburg Kiel Lübeck Lübeck Germany
Heart Center Bad Neustadt Rhoen Clinic Campus Bad Neustadt Bad Neustadt an der Saale Germany
Heart Center University Hospital of Cologne Department for Electrophysiology Cologne Germany
Heart Rhythm Department Clinique Pasteur Toulouse France
Helmsley Electrophysiology Center Icahn School of Medicine at Mount Sinai New York New York
I2MC Institute INSERM UMR 1297 Toulouse France
IKEM Institute for Clinical and Experimental Medicine Prague Czech Republic
Inselspital Bern University Hospital University of Bern Bern Switzerland
Neuron Medical Brno Czech Republic
Universitair Ziekenhuis Brussels Belgium
University Heart and Vascular Center University Medical Center Hamburg Eppendorf Hamburg Germany
Citace poskytuje Crossref.org
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- $a Clinical Outcomes by Sex After Pulsed Field Ablation of Atrial Fibrillation / $c 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. Steven, J. Kautzner, J. Vijgen, P. Jais, J. Petru, J. Chun, L. Roten, A. Füting, MD. Lemoine, M. Ruwald, BA. Mulder, A. Rollin, H. Lehrmann, T. Fink, Z. Jurisic, C. Chaumont, R. Adelino, K. Nentwich, M. Gunawardene, A. Ouss, CH. Heeger, M. Manninger, JE. Bohnen, A. Sultan, P. Peichl, P. Koopman, N. Derval, T. Kueffer, VY. Reddy
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