2.4 Assessment of baseline profile, follow-up, and outcomes
Patients received warfarin for anticoagulation for 6 months after
operation in accordance with published guideline13 and
were followed up for one year after operation.
The primary outcome included indexed EOA and
mean gradient, which were assessed
by hemodynamic performance at 30 days, 3 months, 6 months and 1 year
after operation.
Secondary outcomes were perioperative data and early clinical outcomes,
included transfusion requirement, mechanical ventilation time, length of
ICU and hospital stay, reoperation, PVL, perioperative comobidities,
prosthesis-related mortality and all-cause mortality. Among them, major
bleeding event was defined as blood loss of more than 500 ml within 1
hour or 200 ml per hour for 3 hours or more. Cardiac tamponade and
degree of PVL were determined by echocardiography. Diagnosis of
myocardial infarction was based on the elevation of high-sensitivity
cardiac troponin T and creatine kinase isoenzyme, the onset of new
pathologic Q-waves or new left bundle branch block, or the imaging
evidence of new wall motion
abnormality.14-15The cerebrovascular accident was determined by CT or
magnetic resonance imaging
(MRI) of the head in the presence of
new onset of neurological deficit. Diagnosis of endocarditis was based
on the scientific statement from American Heart
Association.16 Respiratory failure was defined as
partial pressure of oxygen in arterial blood (PaO2)
< 60 mmHg.