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.