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.