Outcomes comparison of 5 coated cardiopulmonary bypass circuits versus an uncoated control group of patients undergoing cardiac surgery. 2009

J Marcoux, and N Sohn, and E McNair, and M Rosin, and G Smith, and H Lim, and T Mycyk, and Q Meng
Department of Clinical Perfusion, Cardiovascular Surgery and Clinical Chemistry, Royal University Hospital, Saskatoon, Saskatchewan, Canada. laterreur2@yahoo.ca

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. CONCLUSIONS 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.

UI MeSH Term Description Entries
D002170 Canada The largest country in North America, comprising 10 provinces and three territories. Its capital is Ottawa.
D002315 Cardiopulmonary Bypass Diversion of the flow of blood from the entrance of the right atrium directly to the aorta (or femoral artery) via an oxygenator thus bypassing both the heart and lungs. Heart-Lung Bypass,Bypass, Cardiopulmonary,Bypass, Heart-Lung,Bypasses, Cardiopulmonary,Bypasses, Heart-Lung,Cardiopulmonary Bypasses,Heart Lung Bypass,Heart-Lung Bypasses
D006348 Cardiac Surgical Procedures Surgery performed on the heart. Cardiac Surgical Procedure,Heart Surgical Procedure,Heart Surgical Procedures,Procedure, Cardiac Surgical,Procedure, Heart Surgical,Procedures, Cardiac Surgical,Procedures, Heart Surgical,Surgical Procedure, Cardiac,Surgical Procedure, Heart,Surgical Procedures, Cardiac,Surgical Procedures, Heart
D006801 Humans Members of the species Homo sapiens. Homo sapiens,Man (Taxonomy),Human,Man, Modern,Modern Man
D000368 Aged A person 65 years of age or older. For a person older than 79 years, AGED, 80 AND OVER is available. Elderly
D012449 Safety Freedom from exposure to danger and protection from the occurrence or risk of injury or loss. It suggests optimal precautions in the workplace, on the street, in the home, etc., and includes personal safety as well as the safety of property. Safeties
D016896 Treatment Outcome Evaluation undertaken to assess the results or consequences of management and procedures used in combating disease in order to determine the efficacy, effectiveness, safety, and practicability of these interventions in individual cases or series. Rehabilitation Outcome,Treatment Effectiveness,Clinical Effectiveness,Clinical Efficacy,Patient-Relevant Outcome,Treatment Efficacy,Effectiveness, Clinical,Effectiveness, Treatment,Efficacy, Clinical,Efficacy, Treatment,Outcome, Patient-Relevant,Outcome, Rehabilitation,Outcome, Treatment,Outcomes, Patient-Relevant,Patient Relevant Outcome,Patient-Relevant Outcomes
D020099 Coated Materials, Biocompatible Biocompatible materials usually used in dental and bone implants that enhance biologic fixation, thereby increasing the bond strength between the coated material and bone, and minimize possible biological effects that may result from the implant itself. Surface-Coated Materials,Biocompatible Coated Materials,Materials, Biocompatible Coated,Materials, Surface-Coated,Surface Coated Materials

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