Definitions and Outcomes Measures
Immediate and delayed procedure related complications were collected according to the Munich Consensus Document (17).
Procedural success was defined as: 1-Technical success and 2-No procedure-related complications.
Technical success was defined as: 1- exclusion of the LAA; 2-No device related complication; and 3-No leak ≥ 5mm on color Doppler TEE.
Device related complications included: device related thrombus (DRT), device embolization, erosion, interference with the surrounding structure (circumflex coronary artery, mitral valve, pulmonary artery, or pulmonary vein), fracture, perforation or laceration, infection, or endocarditis.
Based on the Protect AF trial, an adequate sealing of the LAA was characterized by a jet < 5 mm and a jet ≥ 5 mm was considered as a significant para-prosthetic leak (18).
The procedure related complications included: stroke (hemorrhage or infarction), transient ischemic attack, systemic embolism, life-threatening or major bleeding, pericardial effusion, vascular complication, pericarditis, myocardial infarction, renal failure, hepatic failure, cardiovascular death, and unknown cause death occurring during the follow-up. Major bleeding was defined as one of the following criteria: 1- fatal bleeding; 2- symptomatic bleeding in a critical organ or area (intracranial, intraspinal, intraocular, retroperitoneal, intraarticular, pericardial, intramuscular with compartment syndrome); 3- a fall in the hemoglobin level of ≥ 20 g/L; 4- transfusion of two or more units of whole blood or red cells (19,20). Ischemic stroke was defined as an episode of neurological dysfunction caused by a focal cerebral, spinal, or retinal infarction and could be definitive, transient, or silent (21). Data related to peripheral embolism and hemorrhagic strokes were also collected. The CHA2DS2-VASc and HASBLED score were calculated.