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

Catharina Hospital Eindhoven the Netherlands instead of Catharina Ziekenhuis Eindhoven the Netherlands

Clinic for Electrophysiology Herz und Diabeteszentrum North Rhine Westfalia Ruhr University Bochum Bad Oeynhausen Germany

Department for Cardiovascular Diseases University Hospital Center Split 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 Duisburg Germany

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 Cardiology University of Groningen University Medical Center Groningen Groningen the Netherlands

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

IHU LIRYC Institute Des Maladies Du Rythme Cardiaque CHU Bordeaux University of Bordeaux Bordeaux France

IKEM Institute for Clinical and Experimental Medicine Prague Czech Republic

Inselspital Bern University Hospital University of Bern Bern Switzerland

Medizinisches Versorgungszentrum Cardioangiologisches Centrum Bethanien Frankfurt und Main Taunus GbR Frankfurt Germany

Neuron Medical Brno Czech Republic

Universitair Ziekenhuis Brussels Belgium

University Heart and Vascular Center University Medical Center Hamburg Eppendorf Hamburg Germany

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

JAMA Cardiol. 2023 Dec 1;8(12):1151-1153. doi: 10.1001/jamacardio.2023.4009. PubMed

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