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Arrhythmias and sudden death
Original research
Left atrial appendage closure in very elderly patients in the French National Registry
  1. Emmanuel Teiger1,2,
  2. Romain Eschalier3,4,
  3. Nicolas Amabile5,
  4. Gilles Rioufol6,7,
  5. Gregory Ducrocq8,
  6. Philippe Garot9,
  7. Antoine Lepillier10,
  8. Jacques Bille11,
  9. Meyer Elbaz12,
  10. Pascal Defaye13,
  11. Etienne Audureau14,15,
  12. Philippe Le Corvoisier16,17
  13. French Left Atrial Appendage Closure-2 registry (FLAAC-2) investigators
    1. 1 Department of Cardiology, APHP, Henri Mondor University Hospital, Créteil, France
    2. 2 Clinical Investigation Center 1430 and U955-IMRB team 3, Ecole Nationale Vétérinaire d'Alfort, UPEC, INSERM, Créteil, France
    3. 3 Cardiology Department, Clermont-Ferrand University Hospital, Clermont-Ferrand, France
    4. 4 CHU Clermont-Ferrand, CNRS, SIGMA Clermont, Institut Pascal, University of Clermont Auvergne, Clermont-Ferrand, France
    5. 5 Department of Cardiology, Institut Mutualiste Montsouris, Paris, France
    6. 6 Department of Interventional Cardiology, Lyon Cardiovascular Hospital, Bron Cedex, France
    7. 7 CARMEN INSERM 1060, INSERM, Bron, France
    8. 8 Department of Cardiology, FACT (French Alliance for Cardiovascular Trials), DHU-FIRE, Bichat-Claude Bernard University Hospital, Paris, France
    9. 9 Institut Cardiovasculaire Paris-Sud (ICPS), Ramsay-Santé, Hôpital Privé Jacques Cartier, Massy, France
    10. 10 Department of Cardiology, Centre Cardiologique du Nord, Saint-Denis, France
    11. 11 Cardiology Department, Saint Joseph Hospital, Marseille, France
    12. 12 Department of Cardiology, Rangueil University Hospital, Toulouse, France
    13. 13 Department of Rhythmology, Grenoble-Alpes University Hospital, Grenoble, France
    14. 14 AP-HP, Department of Public Health, Henri Mondor University Hospital, Creteil, France
    15. 15 Equipe CEpiA, INSERM, UPEC, U955-IMRB, Créteil, France
    16. 16 Clinical Investigation Center 1430, APHP, Groupe Hospitalier Henri Mondor, Creteil, France
    17. 17 Clinical Investigation Center 1430 and U955-IMRB team 3, INSERM, Créteil, France
    1. Correspondence to Professor Philippe Le Corvoisier, Clinical Investigation Center 1430, APHP, Groupe Hospitalier Henri Mondor, Creteil 94010, France; philippe.lecorvoisier{at}hmn.aphp.fr

    Abstract

    Objective Left atrial appendage closure (LAAC) is recommended to decrease the stroke risk in patients with atrial fibrillation and contraindications to anticoagulation. However, age-stratified data are scarce. The aim of this study was to provide information on the safety and efficacy of LAAC, with emphasis on the oldest patients.

    Methods A nationwide, prospective, multicentre, observational registry was established by 53 French cardiology centres in 2018–2021. The composite primary endpoint included ischaemic stroke, systemic embolism, and unexplained or cardiovascular death. Separate analyses were done in the groups <80 years and ≥80 years.

    Results Among the 1053 patients included, median age was 79.7 (73.6–84.3) years; 512 patients (48.6%) were aged ≥80 years. Procedure-related serious adverse events were non-significantly more common in octogenarians (7.0% vs 4.4% in patients aged <80 years, respectively; p=0.07). Despite a higher mean CHA2DS2-VASc score in octogenarians, the rate of thromboembolic events during the study was similar in both groups (3.0 vs 3.1/100 patient-years; p=0.85). By contrast, all-cause mortality was significantly higher in octogenarians (15.3 vs 10.1/100 patient-years, p<0.015), due to a higher rate of non-cardiovascular deaths (8.2 vs 4.9/100 patient-years, p=0.034). The rate of the primary endpoint was 8.1/100 patient-years overall with no statistically significant difference between age groups (9.4 and 7.0/100 patient-years; p=0.19).

    Conclusion Despite a higher mean CHA2DS2-VASc score in octogenarians, the rate of thromboembolic events after LAAC in this age group was similar to that in patients aged <80 years.

    Trial registration number ClinicalTrials.gov Registry (NCT03434015).

    • Stroke
    • Atrial Fibrillation
    • Epidemiology

    Data availability statement

    Data are available upon reasonable request.

    https://doi.org/10.1136/heartjnl-2023-322871

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      Data availability statement

      Data are available upon reasonable request.

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      Footnotes

      • Contributors ET, EA, PD and PLC were responsible for the conception, design and planning of the study. All authors (ET, RE, NA, GR, GD, PG, AL, JB, ME, PD, EA, PLC) contributed to the conduct of the study and acquisition of data. ET and PLC were in charge of the global coordination of the study. EA was in charge of the statistical analysis. All authors contributed to the reporting of this work and revised the manuscript for important intellectual content. All authors approved the manuscript submitted. ET and PLC had full access to all the data and are responsible for the overall content as guarantors.

      • Funding This study was supported by unrestricted grants from Boston Scientific and St Jude Medical.

      • Disclaimer Neither funder had any role in the conception, design or conduct of the study; collection, analysis or interpretation of the data; writing of the manuscript; or decision to submit the manuscript for publication.

      • Competing interests ET and PLC received unrestricted research grants from Boston Scientific and St Jude Medical for this study. PG is the medical director and shareholder of CERC (Cardiovascular European Research Center) and received speaker’s and advisory fees from Abbott and Boston Scientific. GR is proctor for Boston Scientific. RE is consultant and has performed proctoring for Boston Scientific and Abbott. None for all other authors.

      • Patient and public involvement Patients and/or the public were not involved in the design, or conduct, or reporting, or dissemination plans of this research.

      • Provenance and peer review Not commissioned; externally peer reviewed.

      • Supplemental material This content has been supplied by the author(s). It has not been vetted by BMJ Publishing Group Limited (BMJ) and may not have been peer-reviewed. Any opinions or recommendations discussed are solely those of the author(s) and are not endorsed by BMJ. BMJ disclaims all liability and responsibility arising from any reliance placed on the content. Where the content includes any translated material, BMJ does not warrant the accuracy and reliability of the translations (including but not limited to local regulations, clinical guidelines, terminology, drug names and drug dosages), and is not responsible for any error and/or omissions arising from translation and adaptation or otherwise.