Incidence and clinical impact of major bleeding following left atrial appendage occlusion: insights from the Amplatzer Amulet Observational Post-Market Study
| Autor: | Jens Erik Nielsen-Kudsk, Boris Schmidt, Juha Lund, Ryan M. Gage, Sergio Berti, Sven Fischer, Patrizio Mazzone, Hans-Christoph Diener, Adel Aminian, Matteo Montorfano, Xavier Freixa, Simon Cheung Chi Lam, Ole De Backer |
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| Rok vydání: | 2021 |
| Předmět: |
medicine.medical_specialty
medicine.medical_treatment Population Atrial Appendage/diagnostic imaging Medizin Hemorrhage/epidemiology Left atrial appendage occlusion Stroke/epidemiology Brain Ischemia Septal Occluder Device/adverse effects Internal medicine medicine Humans Clinical significance In patient education Stroke education.field_of_study business.industry Incidence Incidence (epidemiology) medicine.disease Treatment Outcome Atrial Fibrillation/epidemiology Cardiology Cardiac Catheterization/adverse effects Observational study Cardiology and Cardiovascular Medicine business Major bleeding |
| Zdroj: | Aminian, A, De Backer, O, Nielsen-Kudsk, J E, Mazzone, P, Berti, S, Fischer, S, Lund, J, Montorfano, M, Lam, S C C, Freixa, X, Gage, R, Diener, H-C & Schmidt, B 2021, ' Incidence and Clinical Impact of Major Bleeding Following Left Atrial Appendage Occlusion : insights from the Amplatzer Amulet Observational Post-Market Study ', EuroIntervention : journal of EuroPCR in collaboration with the Working Group on Interventional Cardiology of the European Society of Cardiology, vol. 17, no. 9, pp. 774-782 . https://doi.org/10.4244/EIJ-D-20-01309 |
| ISSN: | 1774-024X |
| Popis: | BACKGROUND: 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.AIMS: 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.METHODS: The two-year results of the Amplatzer Amulet Observational Post-Market Study were analysed. An independent committee adjudicated MBs according to the Bleeding Academic Research Consortium scale. Cox proportional hazards regression identified variables associated with MB events and mortality.RESULTS: 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. 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%; pCONCLUSIONS: 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. ClinicalTrials.gov Identifier: NCT02447081. https://clinicaltrials.gov/ct2/show/NCT02447081. |
| Databáze: | OpenAIRE |
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