The Official Journal of EuroPCR and the European Association of Percutaneous Coronary Interventions (EAPCI)

Interventions for hypertension and stroke

Incidence and clinical impact of major bleeding following left atrial appendage occlusion: insights from the Amplatzer Amulet Observational Post-Market Study

EuroIntervention 2021;17:774-782. DOI: 10.4244/EIJ-D-20-01309

1. Department of Cardiology, Centre Hospitalier Universitaire de Charleroi, Charleroi, Belgium; 2. Department of Cardiology, Rigshospitalet, Copenhagen, Denmark; 3. Department of Cardiology, Aarhus University Hospital, Aarhus, Denmark; 4. Arrhythmology and Cardiac Pacing Unit; 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. Interventional Cardiology Unit, Ospedale San Raffaele, Milan, Italy; 9. Department of Medicine, Queen Mary Hospital, Hong Kong, China; 10. Hospital Clinic de Barcelona, Barcelona, Spain; 11. Structural Heart Clinical Affairs, Abbott, St. Paul, MN, USA; 12. Institute for Medical Informatics, Biometry and Epidemiology, Medical Faculty of the University Duisburg-Essen, Essen, Germany; 13. Cardioangiologisches Centrum Bethanien, Agaplesion Markus Krankenhaus, Medizinische Klinik 3 – Kardiologie, Frankfurt, Germany

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%; p<0.0001), driven mainly by events occurring beyond the periprocedural period. The annualised rate of ischaemic 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).

Conclusions: 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

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