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.

Keywords

CPB Biocompatible coatings cardiac surgery tau protein outcomes

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References

Zimmermann AK , Weber N. , Aebert H. , Ziemer G. , Wendel HP Effect of biopassive and bioactive surface-coatings on hemocompatibility of membrane oxygenators. J Biomed Mater Res B Appl Biomater 2007 Feb; 80(2): 433-439.

Gunaydin S. Clinical significance of coated extracorporeal circuits: a review of novel technologies. Perfusion 2004; 19: Suppl S33-S41.

De Vroege R. , van Oeveren W. , van Klarenbosch J. , Stooker W. The impact of heparin-coated cardiopulmonary bypass circuits on pulmonary function and the release of inflammatory mediators. Artif Organs 2005 Jun; 29(6): 490-497.

Wahba A. , Philipp A. , Behr R. , Birnbaum D. Heparin-coated equipment reduces the risk of oxygenator failure. Ann Thorac Surg 1998; 65: 1310-1312.

Gu YJ , Boonstra PW , Rijnburger AA , Haan J. , van Oeveren W. Cardiopulmonary bypass circuit treated with surface-modifying additives: a clinical evaluation of blood compatibility. Ann Thorac Surg 1998; 65: 1342- 1347.

Palatinos G. , Foroulis C. , Vassili M. , Astras G. A prospective double-blind study on the efficacy of the bioline surface-heparinized extracorporeal perfusion circuit. Ann Thorac Surg 2003; 76: 129-135.

Ranucci M. , Balduini A. , Dita A. , Boncilli A. , Brozzi S. A systematic review of biocompatible cardiopulmonary bypass circuits and clinical outcome. Ann Thorac Surg 2009; 87: 1311-1319.

Baufreton C. , Allain P. , Chevailler A. Brain injury and neuropsychological outcome after coronary artery surgery are affected by complement activation. Ann Thorac Surg 2005; 79: 1597-1605.

Ramlawi B. , Rudolph J. , Mieno S. , et al. Serologic markers of brain injury and cognitive function after cardiopulmonary bypass. Ann Surg 2006; 244(4): 593-601.

10.

Wunderlich MT , Lins H. , Skalej M. , Wallesch M. Neuron-specific enolase and tau protein as neurobiochemical markers of neuronal damage are related to early clinical course and long term outcome in acute ischemic stroke. Clin Neurol Neurosurg 2006 Sep; 108(6): 558-563.

11.

Suleiman M. , Khatib R. , Agmon Y. , Mahamid R. Early inflammation and risk of long-term development of heart failure and mortality in survivors of acute myocardial infarction predictive role of C-reactive protein. J Am Coll Cardiol 2006 Mar 7; 47(5): 962-968.

12.

Guitton D. , Buchtel HA , Douglas RM Frontal lesions in man cause difficulties in suppressing reflexive glances and in generating goal-directed saccades. Exp Brain Res 1985; 58(3): 455-472.

13.

Currie J. , Ramsden B. , McArthur C. , Maruff P. Validation of a clinical antisaccadic eye movement test in the assessment of dementia. Arch Neurol 1991; 48: 644-648.

14.

Klein C. , Fischer B. Instrumental and test-retest reliability of saccadic measures. Biol Psychol 2005 Mar; 68(3): 201-213.

15.

Heyer EJ , Lee KS , Manspeizer HE et al. Heparin-bonded cardiopulmonary bypass circuits reduce cognitive dysfunction. J Cardiothorac Vasc Anesth 2002 ; 16: 37-42.

16.

Gunaydin S. Emerging technologies in biocompatible surface modifying additives: quest for physiologic cardiopulmonary bypass. Curr Med Chem 2004; 2: 295-302.

17.

Ueyama K. , Nishimura K. , Nishina T. , Nakamura T. , Ikeda T. , Komeda M. PMEA coating of pump circuit and oxygenator may attenuate the early systemic inflammatory response in cardiopulmonary bypass surgery. ASAIO J. 2004 Jul-Aug; 50(4): 369-72.

18.

Ikuta T. , Fujii H. , Shibata T. , Hattori K. , Hirai H. , Kumano H. , Suehiro S. A new poly-2-methoxyethylacrylate-coated cardiopulmonary bypass circuit possesses superior platelet preservation and inflammatory suppression efficacy. Ann Thorac Surg. 2004 May; 77(5): 1678-83.

19.

Gunaydin S. , Mccusker K. , Vijay V. Clinical performance and biocompatibility of novel hyaluronan-based heparin-bonded extracorporeal circuits. J Extra Corpor Technol. 2005 Sep; 37(3): 290-5.

20.

Fahrmeir L. and Tutz G. Multivariate statistical modelling based on generalized linear models. New York: Springer, 2001. 2nd edition

21.

SAS Software: Usage and reference. SAS Institute Inc., Version 9.1. Cary, NC, 2002 .

22.

Mongero LB , Beck JR , Manspeizer HE , et al. Cardiac surgical patients exposed to heparin-bonded circuits develop less postoperative cerebral dysfunction than patients exposed to non-heparin-bonded circuits. Perfusion. 2001 Mar; 16(2): 107-111.

23.

Newman MF , Kirchner JL , Phillips-Bute B. , et al. Longitudinal assessment of neurocognitive function after coronary artery bypass surgery. N Engl J Med. 2001 Feb 8; 344(6): 395-402.