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.