End Points
The endpoints of this study refered to the standardized
endpoints/criteria included in the Munich consensus paper on LAAO by
Tzikas et al. (7). The primary end point of the study included
successful implantation of the LAA occlusion device. Successful closure
of the LAA was determined by TEE as the absence of flow or minimal flow
(jet of <5mm width; we set it to be < 3mm width)
around the device according to the echocardiographic sealing criteria
described previously (8). The second end points were the occurrence of
adverse events, which included composite endpoints such as all-cause
mortality, ischemic stroke or systemic embolism, and periprocedural
complications including pericardial effusion/tamponade, bleeding,
pericarditis, myocardial infarction, access-related complications, renal
and hepatic injuries, and device-related complications.