Clinical evaluation of Duraflo® II heparin treated extracorporeal circulation circuits (2nd version) The European working group on heparin coated extracorporeal circulation circuits

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Abstract
OBJECTIVES: To evaluate whether the application of heparin treatedcircuits for elective coronary artery surgery improves postoperativerecovery, a European multicenter randomised clinical trial was carried out.METHODS: In 11 European heart centers, 805 low-risk patients underwentcardiopulmonary bypass (CPB) with either an untreated circuit (n = 407) oran identical but heparin treated circuit (n = 398, Duraflo II). RESULTS:Significant differences were found among participating centers with respectto patient characteristics, blood handling procedures and postoperativecare. The use of heparin treated circuits revealed no overall changes inblood loss, blood use, time on ventilator, occurrence of adverse events,morbidity, mortality, and intensive care stay. These results did not changeafter adjustment for centers and (other) prognostic factors as analysedwith logistic regression. In both groups no clinical or technical (patientor device related) side effects were reported. Because female gender andaortic cross clamp time appeared as prognostic factors in the logisticregression analysis, a subgroup analysis with these variables wasperformed. In a subpopulation of females (n = 99), those receiving heparintreated circuits needed less blood products, had a lower incidence ofrhythm disturbances and were extubated earlier than controls. In anothersubgroup of patients with aortic cross clamp time exceeding 60 min (n =197), the amount of patients requiring prolonged intensive care treatment(> 24 h) was significantly lower when they received heparin treatedcircuits versus controls. CONCLUSION: These findings suggest that improvedrecovery can be expected with heparin treated circuits in specific higherrisk patient populations (e.g. females) and when prolonged aortic crossclamp time is anticipated. Further investigations are recommended toanalyses the clinical benefit of heparin treated circuits in studies withpatients in different well defined risk categories and under betterstandardised circumstances.

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