Follow-up
A systematic clinical follow-up after 12 months was carried out by outpatient visits, phone contact, or hospital stays. Demographic, clinical, and procedural characteristics, as well as adverse events and outcomes, were recorded according to the current recommendations of the European Associations of Percutaneous Coronary Interventions16, the Munich consensus document on definitions, endpoints and data collection requirements 18, the Bleeding Academic Research Consortium (BARC) 19, the clinically relevant non-major bleeding (CRNMB) definition defined by the Scientific and Standardization Committee of the International Society on Thrombosis and Haemostasis for the clinical trials, registries, and cohort studies of AF and venous thromboembolic disease20, the Valve Academic Research Consortium criteria21, and the 2017 Cardiovascular and Stroke Endpoint Definitions for Clinical Trials 22. Device success was defined as the correct deployment and implantation of the Watchman device.
The analysis of the demographic characteristics, procedural data, and clinical outcomes was performed for all patients in a standardized manner. Contemporary risk scores for thromboembolism (CHA2DS2-VASc) and bleeding (HAS-BLED) were calculated 23, 24.