Outcomes comparison of 5 coated cardiopulmonary bypass circuits versus an uncoated control group of patients undergoing cardiac surgery

Abstract

Attenuated inflammatory response and decreased platelet activation have been claimed repeatedly when biocompatible circuits are used for cardiopulmonary bypass. We evaluated five Health Canada approved biocompatible circuit coatings (BCC) against an un-coated control group to determine their effectiveness in improving post-operative outcomes. Patients were assigned to the Control group or one of the 5 coated circuit groups: 40 Control; 33 Trillium; 32 Phisio; 34 Bioline; 33 X; and 11 GBS. Measured outcomes included: ventilator time; ICU time; post-operative chest tube drainage and transfusion volume; high sensitivity C-reactive protein (hsCRP); tau protein; and pre- and 72-hour post-operative anti-saccadic eye movement test comparisons. Results: 183 patients were enlisted into the study. One arm of the study (GBS) was abandoned after 11 patients on account of inconsistent pressure excursions within the oxygenator and the excessive consumption of platelets necessitating transfusion. Patients in the X-coated group had significantly longer ventilator and intensive care unit (ICU) time compared to the three remaining coated circuit study groups. Though not significant, patients in the X group also demonstrated the highest post-operative chest tube losses, the most platelet transfusions, the highest tau protein levels and the lowest post-operative anti-saccadic eye movement test (ASEMT) results compared to the three remaining coated groups. The patients in the Trillium, Bioline and Phisio groups showed an improvement in ventilator and ICU time relative to the Control group. The diabetic patients in the Trillium, Bioline and Phisio groups showed an improvement in bleeding relative to the diabetic patients in the Control group. Conclusion: We compared all 5 coated circuits approved for clinical use in Canada against an uncoated control circuit. Three of the 5 coated circuits (Trillium, Phisio and Bioline BCC) were found to improve ventilator and ICU time compared to Control. Further studies are indicated to validate these results and their impact upon approval criteria, purchasing choices and safe clinical practice, especially as applied to higher risk diabetic patients.