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. 2023 Dec 1;8(12):1142-1151.
doi: 10.1001/jamacardio.2023.3752.

Clinical Outcomes by Sex After Pulsed Field Ablation of Atrial Fibrillation

Mohit K Turagam  1 , Petr Neuzil  2 , Boris Schmidt  3 , Tobias Reichlin  4 , Kars Neven  5   6 , Andreas Metzner  7 , Jim Hansen  8 , Yuri Blaauw  9 , Philippe Maury  10   11 , Thomas Arentz  12 , Philipp Sommer  13 , Ante Anic  14 , Frederic Anselme  15 , Serge Boveda  16   17 , Tom Deneke  18 , Stephan Willems  19 , Pepijn van der Voort  20 , Roland Tilz  21   22 , Moritoshi Funasako  2   23 , Daniel Scherr  24 , Reza Wakili  25 , Daniel Steven  26 , Josef Kautzner  27 , Johan Vijgen  28 , Pierre Jais  29 , Jan Petru  2 , Julian Chun  3 , Laurent Roten  4 , Anna Füting  5   6 , Marc D Lemoine  7 , Martin Ruwald  8 , Bart A Mulder  9 , Anne Rollin  10 , Heiko Lehrmann  12 , Thomas Fink  13 , Zrinka Jurisic  14 , Corentin Chaumont  15 , Raquel Adelino  16   17 , Karin Nentwich  18 , Melanie Gunawardene  19 , Alexandre Ouss  20 , Christian-Hendrik Heeger  21   22 , Martin Manninger  24 , Jan-Eric Bohnen  25 , Arian Sultan  26 , Petr Peichl  27 , Pieter Koopman  28 , Nicolas Derval  29 , Thomas Kueffer  4 , Vivek Y Reddy  1   2
Affiliations

Clinical Outcomes by Sex After Pulsed Field Ablation of Atrial Fibrillation

Mohit K Turagam et al. JAMA Cardiol. .

Abstract

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.

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Conflict of interest statement

Conflict of Interest Disclosures: Dr Schmidt reported receiving grants from Boston Scientific, Medtronic, Biosense Webster, and Abbott outside the submitted work. Dr Reichlin reported receiving grants from Boston Scientific/Farapulse, the Swiss National Science Foundation, the Swiss Heart Foundation, the Swiss Institute for Translational and Entrepreneurial Medicine (sitem insel) support fund, Biotronik, and Medtronic and speaker/consulting honoraria or travel support from Abbott/SJM, Biosense Webster, Biotronik, Boston Scientific, and Medtronic outside the submitted work. Dr Neven reported receiving personal fees from Biosense Webster and Boston Scientific outside the submitted work. Dr Metzner reported receiving personal fees from Boston Scientific, Medtronic, and Biosense Webster outside the submitted work. Dr Hansen reported receiving personal fees from Boston Scientific and Biosense Webster/J&J outside the submitted work. Dr Sommer reported receiving grants from Boston Scientific during the conduct of the study. Dr Anic reported receiving consulting fees from Boston Scientific and Galvanize Therapeutics outside the submitted work. Dr Anselme reported receiving personal fees from Boston Scientific, Medtronic, and Microport CRM, and grants from Medtronic and Boston Scientific outside the submitted work. Dr Boveda reported receiving consultant fees from Boston Scientific, Medtronic, Microport, and Zoll outside the submitted work. Dr Deneke reported receiving speaker fees from Biotronik, Abbott, and Biosense Webster. Dr Willems reported speaker fees from Boston Scientific, Abbott, and Bristol Myers Squibb and grants from Boston Scientific and grants from Abbott outside the submitted work. Dr Tilz reported receiving consultant fees from Boston Scientific, Biotronik, Biosense Webster, and Abbott Medical; speaker honoraria from Boston Scientific, Biotronik, Biosense Webster, Abbott Medical, and Lifetech; and research grants from Abbott, Biosense Webster, and Lifetech outside the submitted work. Dr Wakili reported receiving speaker honoraria from Boston Scientific, Medtronic, Daiichi Sankyo, Bayer, Boehringer Ingelheim, Biotronik, Pfizer, and BMS; advisory board fees from Boston Scientific, Medtronic, Daiichi Sankyo, and Boehringer Ingelheim; participating in clinical trials for Boston Scientific, Boehringer Ingelheim, and Daiichi Sankyo; and receiving research funding from BMS/Pfizer and Boston Scientific. Dr Kautzner reported receiving advisory board fees from Boston Scientific, Biosense Webster, Medtronic, and Abbott outside the submitted work. Dr Jais reported receiving grants from Boston Scientific during the conduct of the study. Dr Roten reported receiving grants from Medtronic, consulting fees from Medtronic, and speaker fees from Abbott outside the submitted work. Dr Lemoine reported receiving grants from Farapulse outside the submitted work. Dr Chaumont reported receiving consultant/speaker fees from Medtronic outside the submitted work. Dr Gunawardene reported receiving personal fees from Farapulse/Boston Scientific, Abbott Medical, Medtronic, and Emmes and travel fees from Biosense Webster outside the submitted work. Dr Heeger reported receiving personal fees from Boston Scientific during the conduct of the study. Dr Manninger reported receiving grants from Bayer Healthcare, Biosense Webster, Biotronik, AOP Orphan, Boston Scientific, Daichii Sankyo, BMS/Pfizer, and Abbott outside the submitted work. Dr Sultan reported receiving personal fees from Boston Scientific, Abbott, Medtronic, and J&J outside the submitted work. Dr Peichl reported receiving personal fees from Boston Scientific outside the submitted work. Dr Koopman reported receiving grants from Medtronic, Boston Scientific, Biotronik, Abbott, Pfizer, Daiichi Sankyo, and Bayer and personal fees from Cardiofocus, Bayer, and Boston Scientific outside the submitted work. Dr Reddy reported receiving grants from Farapulse-Boston Scientific; serving as a consultant for and having equity in Ablacon, Acutus Medical, Affera-Medtronic, Apama Medical–Boston Scientific, Anumana, APN Health, Aquaheart, Atacor, Autonomix, Axon Therapies, Backbeat, BioSig, CardiaCare, CardioNXT/AFTx, Circa Scientific, CoRISMA, Corvia Medical, Dinova-Hangzhou DiNovA EP Technology, East End Medical, EPD-Philips, EP Frontiers, Epix Therapeutics-Medtronic, EpiEP, Eximo, Field Medical, Focused Therapeutics, HRT, Intershunt, Javelin, Kardium, Keystone Heart, LuxMed, Medlumics, Middlepeak, Neutrace, Nuvera-Biosense Webster, Oracle Health, Restore Medical, Sirona Medical, SoundCath, and Valcare; serving as a consultant for AtriAN, Biosense-Webster, BioTel Heart, Biotronik, Cairdac, Cardiofocus, Cardionomic, CoreMap, Fire1, Gore & Associates, Impulse Dynamics, Medtronic, Novartis, Philips, and Pulse Biosciences; and having equity in Manual Surgical Sciences, Newpace, Nyra Medical, Surecor, and Vizaramed outside the submitted work. No other disclosures were reported.

Figures

Figure.
Figure.. Kaplan-Meier (KM) Analysis of Freedom From Atrial Arrhythmia by Sex
The primary effectiveness outcomes are shown for both the full patient cohort (A) and separated by atrial fibrillation (AF) subtype: paroxysmal AF (B) vs persistent AF/long-standing (LS)–persistent AF (C).
See this image and copyright information in PMC

Comment in

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