Giuseppe Tarantini1, Gianpiero D'Amico2, Boris Schmidt3, Patrizio Mazzone4, Sergio Berti5, Sven Fischer6, Juha Lund7, Matteo Montorfano4, Paolo Della Bella4, Simon Cheung Chi Lam8, Ignacio Cruz-Gonzalez9, Ryan Gage10, Hong Zhao10, Heyder Omran11, Jacob Odenstedt12, Jens Erik Nielsen-Kudsk13. 1. Interventional Cardiology Unit, Department of Cardiology Thoracic and Vascular Sciences and Public Health, University of Padua, Italy. Electronic address: giuseppe.tarantini.1@gmail.com. 2. Interventional Cardiology Unit, Department of Cardiology Thoracic and Vascular Sciences and Public Health, University of Padua, Italy. Electronic address: https://twitter.com/gianpiero_d. 3. Cardioangiologisches Centrum Bethanien, Frankfurt, Germany. 4. Ospedale San Raffaele, Milan, Italy. 5. Department of Interventional and Diagnostic Cardiology, Fondazione Toscana Gabriele Monasterio, Pisa, Italy. 6. Department of Cardiology, Harzklinikum Dorothea Christiane Erxleben GmbH, Quedlinburg, Germany. 7. Heart Center, Turku University Hospital, Turku, Finland. 8. Department of Medicine, Queen Mary Hospital, Hong Kong. 9. Department of Medicine, Universitario de Salamanca, Salamanca, Spain. 10. Abbott, St. Paul, Minnesota. 11. Department of Medicine-Cardiology, St. Marien Hospital, Bonn, Germany. 12. Department of Cardiology, Sahlgrenska University Hospital, Gothenburg, Sweden. 13. Department of Cardiology, Aarhus University Hospital, Aarhus, Denmark.
Abstract
OBJECTIVES: The 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. BACKGROUND: Baseline 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). METHODS: Subjects were stratified according to CHA2DS2-VASc and HAS-BLED scores. Clinical outcomes were collected through 2 years and adjudicated by an independent committee. RESULTS: Subjects 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. CONCLUSIONS: LAAO 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).
OBJECTIVES: The 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. BACKGROUND: Baseline CHA2DS2-VASc and HAS-BLED scores have been validated in atrial fibrillationpatients to guide about anticoagulation but not in patients treated by left atrial appendage occlusion (LAAO). METHODS: Subjects were stratified according to CHA2DS2-VASc and HAS-BLED scores. Clinical outcomes were collected through 2 years and adjudicated by an independent committee. RESULTS: Subjects 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. CONCLUSIONS:LAAO 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).