Patient Enrollment
We enrolled thirty patients on a rolling basis with a planned elective
or urgent valvular procedure (aortic or mitral), coronary artery bypass
grafting, or both; requiring CPB. We included minimally invasive aortic
valvular replacements (n=1). Our exclusion criteria included: planned
aortic arch or root procedures, patients with a recent stroke (within
the last year), heavily calcified aortas, high-grade carotid stenosis,
chronic renal failure (Cr>2.0mg/dL), hepatic cirrhosis,
severe neurological deficits, severe or total vision impairment, or an
inability to complete baseline neurocognitive testing. Patients were not
randomized as they were compared to their own pre-operative
neurocognitive assessment. Furthermore, we only included patients who
were native English speakers.
Patients were then divided into four groups: patients without diabetes
(HbA1c <6.2), patients with well-controlled diabetes (HbA1c
6.2-7), patients with moderately controlled diabetes (HbA1c 7-8.5%),
and patients with poorly controlled diabetes (HbA1c
>8.5%). Both male and female patients were included
(female=9; 30%). The post-operative timepoint for the RBANS analysis
was chosen as POD 4 as it was the anticipated discharge date for
patients without complications. All patients provided informed consent
and all procedures were approved by the Institutional Review Board of
Rhode Island Hospital, Alpert Medical School of Brown University.