The Impact of CHA2DS2-VASc and HAS-BLED Scores on Clinical Outcomes in the Amplatzer Amulet Study |
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Institution: | 1. Interventional Cardiology Unit, Department of Cardiology Thoracic and Vascular Sciences and Public Health, University of Padua, Italy;2. Cardioangiologisches Centrum Bethanien, Frankfurt, Germany;3. Ospedale San Raffaele, Milan, Italy;4. Department of Interventional and Diagnostic Cardiology, Fondazione Toscana Gabriele Monasterio, Pisa, Italy;5. Department of Cardiology, Harzklinikum Dorothea Christiane Erxleben GmbH, Quedlinburg, Germany;6. Heart Center, Turku University Hospital, Turku, Finland;7. Department of Medicine, Queen Mary Hospital, Hong Kong;8. Department of Medicine, Universitario de Salamanca, Salamanca, Spain;9. Abbott, St. Paul, Minnesota;10. Department of Medicine–Cardiology, St. Marien Hospital, Bonn, Germany;11. Department of Cardiology, Sahlgrenska University Hospital, Gothenburg, Sweden;12. Department of Cardiology, Aarhus University Hospital, Aarhus, Denmark |
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Abstract: | ObjectivesThe aim of this study was to evaluate the impact of CHA2DS2-VASc and HAS-BLED scores on ischemic and bleeding events of patients enrolled in the Amplatzer Amulet Observational Study.BackgroundBaseline CHA2DS2-VASc and HAS-BLED scores have been validated in atrial fibrillation patients to guide about anticoagulation but not in patients treated by left atrial appendage occlusion (LAAO).MethodsSubjects were stratified according to CHA2DS2-VASc and HAS-BLED scores. Clinical outcomes were collected through 2 years and adjudicated by an independent committee.ResultsSubjects were considered at low (n = 156), moderate (n = 715), and high (n = 215) risk for ischemic stroke, corresponding to CHA2DS2-VASc scores of <3, 3 to 5, and ≥6, respectively. The annual rates of ischemic stroke were 1.1%, 2.0%, and 3.5%, respectively. When compared with the predicted rate, LAAO reduced the risk of ischemic stroke by 56%, 69%, and 68%. Device-related thrombus occurred in 0.7%, 1.5%, and 3.0% of subjects at low, moderate, and high risk for ischemic stroke, respectively. The HAS-BLED score was ≤3 in 629 subjects and >3 in 456 subjects, respectively. Non-peri-procedural major bleeding was reduced by 11% and 9% compared with predicted rates in the low and high bleeding risk groups, respectively.ConclusionsLAAO with the Amplatzer Amulet reduced the risk of ischemic stroke compared with the predicted rate, with a greater magnitude among patients at high thromboembolic risk without increasing the bleeding risk. (Amplatzer?Amulet? Post-Market Study Amulet?PMS]; NCT02447081) |
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Keywords: | Amplatzer Amulet occluder atrial fibrillation left atrial appendage closure AF"} {"#name":"keyword" "$":{"id":"kwrd0030"} "$$":[{"#name":"text" "_":"atrial fibrillation CI"} {"#name":"keyword" "$":{"id":"kwrd0040"} "$$":[{"#name":"text" "_":"confidence interval DRT"} {"#name":"keyword" "$":{"id":"kwrd0050"} "$$":[{"#name":"text" "_":"device-related thrombus LAA"} {"#name":"keyword" "$":{"id":"kwrd0060"} "$$":[{"#name":"text" "_":"left atrial appendage LAAO"} {"#name":"keyword" "$":{"id":"kwrd0070"} "$$":[{"#name":"text" "_":"left atrial appendage occlusion OAC"} {"#name":"keyword" "$":{"id":"kwrd0080"} "$$":[{"#name":"text" "_":"oral anticoagulation TEE"} {"#name":"keyword" "$":{"id":"kwrd0090"} "$$":[{"#name":"text" "_":"transesophageal echocardiogram TIA"} {"#name":"keyword" "$":{"id":"kwrd0100"} "$$":[{"#name":"text" "_":"transient ischemic attack |
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