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ORIGINAL RESEARCH article

Front. Cardiovasc. Med.
Sec. Sex and Gender in Cardiovascular Medicine
Volume 11 - 2024 | doi: 10.3389/fcvm.2024.1419018
This article is part of the Research Topic Insights in Sex and Gender in Cardiovascular Medicine: 2023 View all 6 articles

Gender differences in Outcomes after Left Atrial Appendage Closure with Watchman FLX Device: Insights from the Italian-FLX Registry

Provisionally accepted
Michela Bonanni Michela Bonanni 1,2Marco Frazzetto Marco Frazzetto 3Annalisa Nardone Annalisa Nardone 1Francesco Meucci Francesco Meucci 4Carmine Musto Carmine Musto 5Salvatore Saccà Salvatore Saccà 6Gaetano Quaranta Gaetano Quaranta 7Francesco Bedogni Francesco Bedogni 8Diego Maffeo Diego Maffeo 9Fabrizio Ugo Fabrizio Ugo 10Fabrizio Guarracini Fabrizio Guarracini 11Giacomo Bocuzzi Giacomo Bocuzzi 12Alessandro Durante Alessandro Durante 13Antonino Granatelli Antonino Granatelli 14Gabriele Tumminello Gabriele Tumminello 15Geppina Eusebio Geppina Eusebio 16Calermo Grasso Calermo Grasso 17Federico De Marco Federico De Marco 18Bernardo Cortese Bernardo Cortese 19Massimiliano Mariani Massimiliano Mariani 1Sergio Berti Sergio Berti 1*
  • 1 Heart-Massa Hospital, Toscana Gabriele Monasterio Foundation, Pisa, Italy
  • 2 Department of Biomedicine and Prevention, University Hospital Tor Vergata, Roma, Italy
  • 3 Division of Cardiology, A.O.U. G. Rodolico Polyclinic - San Marco in Catania, Catania, Italy
  • 4 Structural Interventional Cardiology, Careggi University Hospital, Firenze, Italy
  • 5 Division of Cardiology, San Camillo-Forlanini Hospital, Rome, Italy
  • 6 Division of Rehabilitation Cardiology, Azienda ULSS 3 Serenissima, Mestre, Italy
  • 7 Department of Cardiology and Intensive Care, Umberto I Hospital, Rome, Italy
  • 8 Department of Cardiology, IRCCS San Donato Polyclinic, Milano, Italy
  • 9 Valve Center, Poliambulanza Foundation Hospital, Brescia, Italy
  • 10 Department of Cardiology, Pediatric hospital S. Andrea, Vercelli, Italy
  • 11 Electrophysiology Unit, Department of Cardio-Thoraco-Vascular, Niguarda Ca' Granda Hospital, Milano, Italy
  • 12 Division of Cardiology, San Giovanni Bosco Hospital, ASL Città di Torino, Turin, Italy, Torino, Italy
  • 13 Policlinico San Marco, Zingonia, Italy
  • 14 Department of Cardiology, Sandro Pertini Hospital, Rome, Italy
  • 15 Department of Cardio-Thoracic-Vascular Diseases, Foundation IRCCS Ca' Granda Ospedale Maggiore Policlinico, 20122 Milan, Italy, Milano, Japan
  • 16 Division of Cardiology, Maria SS Addolorata Hospital of Eboli, Salerno, Salerno, Italy
  • 17 Division of Cardiology, A.O.U. Policlinico "G. Rodolico San Marco", 95123 Catania, Italy, Catania, Italy
  • 18 Department of Cardiology, Monzino Cardiology Center, Milan, Italy, Milano, Italy
  • 19 Cardiovascular Research Center, Fondazione Ricerca e Innovazione Cardiovascolare, Milan, Italy, Milano, Italy

The final, formatted version of the article will be published soon.

    Introduction: Current studies have revealed gender-specific differences in cardiovascular outcomes following left atrial appendage closure (LAAC), showing varied results in complication rates and adverse events, especially in short-term assessments. As a result, a notable knowledge gap persists regarding how these differences directly affect the effectiveness and safety of LAAC procedures. The objective of this retrospective study was to examine the clinical outcomes LAAC in both women and men with the Watchman FLX device.: This retrospective multicenter study analyzes gender-specific outcomes in 650 patients who underwent LAAC with the Watchman FLX device between March 2019 and May 2022, drawn from the PAGE \* Arabic \* MERGEFORMAT 3 ITALIAN-FLX registry.Results: Findings reveal comparable rates of all-cause mortality, stroke, transient ischemic attack, and major bleeding between men and women at 12 months post-procedure. Notably, no significant gender differences are observed in periprocedural complications or device-related thrombosis and peridevice leak < 5 mm at 45 days post-procedure.In conclusion, this study highlights that (LAAC) with the Watchman FLX device demonstrates comparable clinical outcomes between genders at both short and long-term follow-up intervals. The findings suggest that gender-specific differences in peri-procedural complications may not significantly impact overall outcomes.

    Keywords: gender differences, Left atrial appendage occlusion, Watchman FLX, short and long term outcome, Atrial Fibrillation

    Received: 17 Apr 2024; Accepted: 19 Jun 2024.

    Copyright: © 2024 Bonanni, Frazzetto, Nardone, Meucci, Musto, Saccà, Quaranta, Bedogni, Maffeo, Ugo, Guarracini, Bocuzzi, Durante, Granatelli, Tumminello, Eusebio, Grasso, De Marco, Cortese, Mariani and Berti. This is an open-access article distributed under the terms of the Creative Commons Attribution License (CC BY). The use, distribution or reproduction in other forums is permitted, provided the original author(s) or licensor are credited and that the original publication in this journal is cited, in accordance with accepted academic practice. No use, distribution or reproduction is permitted which does not comply with these terms.

    * Correspondence: Sergio Berti, Heart-Massa Hospital, Toscana Gabriele Monasterio Foundation, Pisa, Italy

    Disclaimer: All claims expressed in this article are solely those of the authors and do not necessarily represent those of their affiliated organizations, or those of the publisher, the editors and the reviewers. Any product that may be evaluated in this article or claim that may be made by its manufacturer is not guaranteed or endorsed by the publisher.