{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,11,1]],"date-time":"2026-11-01T03:11:12Z","timestamp":1793502672359,"version":"4.5.0"},"reference-count":14,"publisher":"American Medical Association (AMA)","issue":"5","content-domain":{"domain":[],"crossmark-restriction":false},"short-container-title":["JAMA Cardiol"],"published-print":{"date-parts":[[2026,5,1]]},"abstract":"\n Importance<\/jats:title>\n Left atrial appendage occlusion (LAAO) is used in patients with contraindications to oral anticoagulation, who are at increased risk for major bleeding (MB).<\/jats:p>\n <\/jats:sec>\n \n Objective<\/jats:title>\n To evaluate the incidence, predictors, management, and clinical outcomes of MB after LAAO in the Amulet IDE trial.<\/jats:p>\n <\/jats:sec>\n \n Design, Setting, and Participants<\/jats:title>\n The randomized clinical Amulet IDE trial enrolled patients from 2016 through 2019 with 5-year follow-up. Procedures were performed at specialized LAAO centers. Of 1878 randomized patients (1:1 Amulet vs Watchman), 1833 underwent attempted LAAO implantation. These data were analyzed from May 2025 through November 2025.<\/jats:p>\n <\/jats:sec>\n \n Main Outcomes and Measures<\/jats:title>\n Pooled (Amulet and Watchman) patients with vs without MB (Bleeding Academic Research Consortium [BARC] score \u22653: overt bleeding with transfusion and \u22653 g\/dL hemoglobin drop) were compared.<\/jats:p>\n <\/jats:sec>\n \n Results<\/jats:title>\n \n This study included a total of 1833 patients (57.7% male and 42.3% female; mean [SD] age, 75.8 [7.5] years). MB occurred in 331 patients (18.1%) over 5 years (annualized rate 5.9% per year). Patients with MB were older (76.8 vs 74.7 years) and had higher CHA\n 2<\/jats:sub>\n DS\n 2<\/jats:sub>\n -VASc (4.8 vs 4.6) and HAS-BLED (3.4 vs 3.2) scores, as well as greater prevalence of diabetes (38.7% vs 34.1%), prior MB (45.3% vs 28.0%), and kidney disease (9.4% vs 4.5%). MB risk was highest in the first 6 months after LAAO (20.5% per year), then decreased to 3.9% per year through 5 years. Most MB events were nonprocedural (88.8%) with gastrointestinal bleeding accounting for 252 of 438 events. Independent predictors of MB included increasing age (hazard ratio [HR], 1.04; 95% CI, 1.02-1.06), female sex (HR, 1.25; 95% CI, 1.01-1.56), diabetes (HR, 1.26; 95% CI, 1.01-1.58), prior MB (HR, 1.93; 95% CI, 1.55-2.40), and kidney disease (HR, 2.15; 95% CI, 1.48, 3.12). At first MB event, 47.1% of patients were not receiving antithrombotic therapy and 92 patients had recurrent events. Patients with MB had significantly higher rates of the composite of stroke, systemic embolism, or cardiovascular death (32.5% vs 18.0%;\n P<\/jats:italic>\n \u2009&amp;lt;\u2009.001), driven by higher stroke (14.7% vs 6.6%) and cardiovascular death (24.4% vs 12.9%) rates. All-cause mortality was also higher (49.2% vs 25.4%;\n P<\/jats:italic>\n \u2009&amp;lt;\u2009.001). MB was fatal (BARC score of 5) in 25 patients (1.4%).\n <\/jats:p>\n <\/jats:sec>\n \n Conclusions and Relevance<\/jats:title>\n In this study, MB was common in this high-risk population and largely related to underlying patient factors. Early MB risk was highest 6 months post-LAAO, then dropped considerably. Most events were gastrointestinal and occurred even in patients on minimal or no antithrombotic therapy. MB after LAAO was strongly associated with increased stroke and mortality.<\/jats:p>\n <\/jats:sec>\n \n Trial Registration<\/jats:title>\n \n ClinicalTrials.gov Identifier:\n NCT02879448<\/jats:ext-link>\n <\/jats:p>\n <\/jats:sec>","DOI":"10.1001\/jamacardio.2026.0336","type":"journal-article","created":{"date-parts":[[2026,3,25]],"date-time":"2026-03-25T15:30:25Z","timestamp":1774452625000},"page":"469","source":"Crossref","is-referenced-by-count":6,"title":["Incidence, Predictors, Management, and Clinical Impact of Major Bleeding Following Left Atrial Appendage Occlusion"],"prefix":"10.1001","volume":"11","author":[{"given":"Boris","family":"Schmidt","sequence":"first","affiliation":[{"name":"Cardioangiologisches Centrum Bethanien, Frankfurt, Germany"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Stephan","family":"Windecker","sequence":"additional","affiliation":[{"name":"Inselspital, University of Bern, Bern, Switzerland"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"David","family":"Thaler","sequence":"additional","affiliation":[{"name":"Tufts Medical Center, Boston, Massachusetts"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Christopher R.","family":"Ellis","sequence":"additional","affiliation":[{"name":"Vanderbilt Heart Institute, Nashville, Tennessee"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Jens Erik","family":"Nielsen-Kudsk","sequence":"additional","affiliation":[{"name":"Aarhus University Hospital, Aarhus N, Denmark"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Xavier","family":"Freixa","sequence":"additional","affiliation":[{"name":"Hospital Clinic of Barcelona, Barcelona, Spain"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Adel","family":"Aminian","sequence":"additional","affiliation":[{"name":"Department of Cardiology, Centre Hospitalier Universitaire de Charleroi, Charleroi, Belgium"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Jordan A.","family":"Anderson","sequence":"additional","affiliation":[{"name":"Abbott Structural Heart, Plymouth, Minnesota"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Ryan","family":"Gage","sequence":"additional","affiliation":[{"name":"Abbott Structural Heart, Plymouth, Minnesota"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Mohamad","family":"Alkhouli","sequence":"additional","affiliation":[{"name":"Mayo Clinic, Rochester, Minnesota"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Dhanunjaya","family":"Lakkireddy","sequence":"additional","affiliation":[{"name":"Kansas City Heart Rhythm Institute and Research Foundation, Overland Park, 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