TY - JOUR JO - EuroIntervention TI - Incidence and Clinical Impact of Major Bleeding Following Left Atrial Appendage Occlusion: Insights from the Amplatzer™ Amulet™ LAA Occluder Observational Study AB - <p><strong>Background: </strong>Major bleeding (MB) events are independent predictors of mortality after cardiac interventional procedures. The clinical relevance of MB following left atrial appendage occlusion (LAAO) remains unclear.</p> <p><strong>Aims:</strong> This study aimed to investigate the incidence and clinical impact of MB after LAAO in a real-world population at high-risk for bleeding and contraindicated to anticoagulation.</p> <p><strong>Methods: </strong>The 2-year results of the Amplatzer&trade; Amulet&trade; Occluder Observational Study were analyzed.&nbsp; An independent committee adjudicated MBs according to the Bleeding Academic Research Consortium scale. &nbsp;Cox proportional hazards regression identified variables associated with MB events and mortality.</p> <p><strong>Results:</strong> The MB rate was 7.2%/year, with a rate of 10.1%/year during year one, decreasing to 4.0%/year over year two.&nbsp; The most common bleeding location was gastrointestinal, accounting for 48% of MBs. Pre-LAAO MB was associated with an increased risk for post-LAAO MB (HR 2.34; 95% CI 1.37-3.99). The occurrence of post-LAAO MB was associated with increased mortality (37.3% vs 12.7%; p&lt;0.0001), mainly driven by events occurring beyond the peri-procedural period.&nbsp; The annualized rate of ischemic stroke or TIA was similar in patients with and without MB (2.3% vs 3.3%; p=0.446). MB post-LAAO was a strong independent predictor of mortality (HR 3.07; 95% CI 2.15-4.40).</p> <p><strong>Conclusions:</strong> In real-world patients at high bleeding risk, MB following LAAO was not uncommon and associated with a significant increase in mortality, without increasing the risk of stroke.</p> AU - Aminian Adel AU - De Backer Ole AU - Nielsen-Kudsk Jens Erik AU - Mazzone Patrizio AU - Berti Sergio AU - Fischer Sven AU - Lund Juha AU - Montorfano Matteo AU - Lam Simon Cheung Chi AU - Freixa Xavier AU - Gage Ryan AU - Diener Hans-Christoph AU - Schmidt Boris VL - IS - Y1 - 26/01/2021 Y1 - 2021 DOI - 10.4244/EIJ-D-20-01309 SP - KW - laa closure KW - bleeding KW - death KW - stroke PB - Europa Digital & Publishing UR - https://eurointervention.pcronline.com/article/incidence-and-clinical-impact-of-major-bleeding-following-left-atrial-appendage-occlusioninsights-from-the-amplatzer-amulet-laa-occluder-observational-study SN - 1774-024X ER -