Primary and Secondary Endpoints:
The primary endpoint for this study was overall mortality throughout the
follow-up period extending to 9 years after the TAVR procedure.
Secondary endpoints included aortic valve revision, myocardial
infarction, newly recognized arrhythmia, new-onset angina, cardiac
arrest, coronary artery bypass grafting, coronary angioplasty, stroke,
endocarditis, and prosthetic valve insufficiency.
The independent variables included: ELI values calculated based on the
native aortic valve and the effective aortic orifice area (EOA) after
TAVR, demographic data, type of prosthesis, and presence of preoperative
aortic valve insufficiency.
Clinical and demographic baseline characteristics and routine
preoperative hemodynamic variables were collected from the medical
records and existing preoperative trans-thoracic echocardiography (TTE),
transesophageal echocardiography (TEE), and left/right cardiac
catheterization database. The ELI value was calculated using the
formula (AVA * ASTJ / (ASTJ − AVA)) /
(body surface area in M2), where AVA is the aortic
valve area and ASTJ is the aortic area at the
sinotubular junction 5.
The AVA for the native valves were the values obtained by TTE before the
TAVR procedure. The EOA replaced this value for any individual implanted
with TAVR in postoperative TTE exams. Prosthetic aortic valve
characteristics, including the prosthesis diameter, height,
bovine/porcine-derived, trans-femoral/apical/aortic implantation, and
sheath size, were obtained by reviewing the manufacturer manual.