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Clinical Trial
. 2022 Nov 14;15(21):2143-2155.
doi: 10.1016/j.jcin.2022.06.037. Epub 2022 Oct 12.

Sex Differences in Safety and Effectiveness of LAAO: Insights From the Amulet IDE Trial

Mohamad Alkhouli  1 , Andrea M Russo  2 , David Thaler  3 , Stephan Windecker  4 , Jordan A Anderson  5 , Ryan Gage  5 , Dhanunjaya Lakkireddy  6
Affiliations
Free article
Clinical Trial

Sex Differences in Safety and Effectiveness of LAAO: Insights From the Amulet IDE Trial

Mohamad Alkhouli et al. JACC Cardiovasc Interv. .
Free article

Abstract

Background: Women have higher rates of acute complications after left atrial appendage occlusion (LAAO). However, data on long-term safety and effectiveness are limited.

Objectives: The aim of this study was to examine sex-specific short- and long-term outcomes after LAAO in the Amulet IDE (Amplatzer™ Amulet™ LAA Occluder) trial.

Methods: The following outcomes were compared between men and women: in-hospital complications, device-related outcomes (peridevice leak at 45 days and device-related thrombus at 18 months), and long-term clinical outcomes (death, thromboembolism, and bleeding). Subanalyses for the interaction between sex and device type were performed.

Results: A total of 1,833 patients underwent attempted device implantation (917 with the Amulet and 916 with the Watchman), of whom 734 were women (40%). Device success was 97.4% in men and 97.1% in women (P = 0.60). Rates of major in-hospital adverse events were higher in women (4.4% vs 1.9%; P < 0.01), driven by major bleeding (3.7% vs 1.0%; P < 0.01) and pericardial effusion requiring intervention (2.0% vs 0.5%; P < 0.01). Peridevice leak and device-related thrombus were similar in men and women (18.3% vs 18.9% [P = 0.78] and 3.3% vs 5.0% [P = 0.10], respectively). There were no differences between men and women in rates of ischemic stroke or systemic embolism (2.6% vs 2.6%; P = 0.98), transient ischemic attack (1.3% vs 1.6%; P = 0.69), hemorrhagic stroke (0.5% vs 0.4%; P = 0.88), major bleeding (10.1% vs 10.9%; P = 0.49), cardiovascular death (4.3% vs 3.5%; P = 0.45), or all-cause death (8.9% vs 6.9%; P = 0.16).

Conclusions: In the Amulet IDE trial, long-term clinical outcomes including effectiveness following LAAO were comparable in men and women despite the higher rates of in-hospital complications due to major bleeding and pericardial effusion in women. (Amplatzer™ Amulet™ LAA Occluder Trial [Amulet IDE]; NCT02879448).

Keywords: atrial fibrillation; left atrial appendage occlusion; sex differences; stroke.

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Conflict of interest statement

Funding Support and Author Disclosures Abbott funded the Amulet IDE Trial. No funding was provided for this analysis. Dr Alkhouli serves as a consultant to Boston Scientific and Abbott. Dr Russo has received research support to the institution from Boston Scientific, Bristol Myers Squibb/Pfizer, Kestra, Medilynx, and Medtronic; is a consultant for Abbott, Atricure, Biosense Webster, Boston Scientific, Medtronic and PaceMate; has received honoraria for speaking from Biotronik, Bristol Myers Squibb/Pfizer and Medtronic; and has received royalties from Up-to-Date. Dr Thaler has received consulting fees from Abbott and Occlutech; and has received institutional research grants for clinical trials from Abbott and the National Institutes of Health. Prof Windecker has received research and educational grants to the institution from Abbott, Abiomed, Amgen, AstraZeneca, Bayer, Biotronik, Boehringer Ingelheim, Boston Scientific, Bristol Myers Squibb, Cardinal Health, CardioValve, Corflow Therapeutics, CSL Behring, Daiichi Sankyo, Edwards Lifesciences, Guerbet, Infraredx, Janssen-Cilag, Johnson & Johnson, Medicure, Medtronic, Merck Sharp & Dohme, Miracor Medical, Novartis, Novo Nordisk, Organon, OrPha Suisse, Pfizer, Polares, Regeneron, Sanofi, Servier, Sinomed, Terumo, Vifor, and V-Wave; serves as an unpaid advisory board member and/or unpaid member of the steering or executive groups of trials funded by Abbott, Abiomed, Amgen, AstraZeneca, Bayer, Boston Scientific, Biotronik, Bristol Myers Squibb, Edwards Lifesciences, Janssen, MedAlliance, Medtronic, Novartis, Polares, Recardio, Sinomed, Terumo, V-Wave, and Xeltis (but has not received personal payments from pharmaceutical companies or device manufacturers); and is a member of the steering or executive committee groups of several investigator-initiated trials that receive funding from industry without impact on his personal remuneration. Dr Anderson and Mr Gage are employees of Abbott. Dr Lakkireddy has received research and educational grants to the institution from Abbott, Atricure, Alta Thera, Medtronic, Biosense Webster, Biotronik, and Boston Scientific; and has received speaker honoraria from Abbott, Medtronic, Biotronik, and Boston Scientific.

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