Randomized controlled trial of pericardial blood processing with a cell-saving device on neurologic markers in elderly patients undergoing coronary artery bypass graft surgery.

BACKGROUND: Processing of pericardial shed blood with a cell-saving device was claimed to prevent lipid microembolization and to protect from neurocognitive dysfunction after cardiopulmonary bypass. The present study tested the hypothesis that processing of pericardial shed blood with a cell-saving device during cardiopulmonary bypass would significantly decrease serum levels of protein S100B, and improve brain oxygen saturation and neurologic outcome, all markers of brain injury in elderly patients.
METHODS: Forty patients, 65 years of age and older, undergoing coronary artery bypass graft with cardiopulmonary bypass, were prospectively randomly assigned to processing of pericardial shed blood with a cell-saving device or to conventional use of a standard closed venous reservoir where cardiotomy blood was collected and reinfused through the arterial circuit (control group). Serum in S100B was measured 30 minutes, 4 hours, 24 hours, and 48 hours after surgery. Near-infrared spectroscopy monitoring was performed during the procedure and the National Institutes of Health stroke scale was measured before surgery and at the time of discharge of the hospital.
RESULTS: Patients in the cell-saving device group averaged 72 +/- 3 years of age and underwent 3.1 +/- 0.7 coronary artery grafts with a mean of 62 +/- 20 minutes of cardiopulmonary bypass time. Patients in the control group averaged 75 +/- 4 years of age (p = 0.03) and underwent 3.3 +/- 0.6 coronary artery grafts (p = 0.49) with a mean of 75 +/- 25 minutes of cardiopulmonary bypass time (p = 0.12). The quantity of blood administered from the cell-saving device averaged 281 +/- 162 mL per patient. Serum protein S100B levels averaged 0.06 +/- 0.03 before surgery and 0.51 +/- 0.23 microg/L 30 minutes after surgery in the cell-saving device patients compared with 0.076 +/- 0.04 before surgery (p = 0.32) and 1.48 +/- 0.66 (p < 0.0001) in the control patients. The near-infrared spectroscopy baseline mean value of left and right cortical region was 58% +/- 12% and 55% +/- 7% in the cell-saving device group versus 59% +/- 7% and 53% +/- 6% in the control group (p = 0.67 and 0.36), and no difference occurred over time in each group. The National Institutes of Health stroke score before and after surgery was similar in the two groups. There was one cerebrovascular complication in the control group (1 of 20, 5%) after surgery.
CONCLUSIONS: The difference between the two groups occurred 30 minutes after surgery, at which time serum levels of protein S100B were significantly higher in the control group compared with cell-saving device patients. Although use of the cell-saving device was not associated with higher brain oxygen saturation nor changes in the National Institutes of Health stroke score, it is associated with lesser release of nonspecific markers of brain injury in elderly patients.

RCT Entities:   Population Interventions Outcomes