CLINICAL-EVALUATION OF DURAFLO(R)-II HEPARIN TREATED EXTRACORPOREAL-CIRCULATION CIRCUITS (2ND VERSION) - THE EUROPEAN WORKING GROUP ON HEPARIN COATED EXTRACORPOREAL-CIRCULATION CIRCUITS

Objectives: To evaluate whether the application of heparin treated cir cuits for elective coronary artery surgery improves postoperative reco very, a European multicenter randomised clinical trial was carried out . Methods: In Il European heart centers. 805 low-risk patients underwe nt cardiopulmonary bypass (CPB) with either an untreated circuit (n = 407) or an identical but heparin treated circuit (n = 398, Duraflu(R)I I). Results: Significant differences were found among participating ce nters with respect to patient characteristics. blood handling procedur es and postoperative care. The use of heparin treated circuits reveale d no overall changes in blood loss, blood use, time on ventilator, occ urrence of adverse events: morbidity, mortality, and intensive care st ay. These results did not change after adjustment for centers and (oth er) prognostic factors as analysed with logistic regression. In both g roups no clinical or technical (patient or device related) side effect s were reported. Because Female gender and aortic cross clamp lime app eared as prognostic factors in the logistic regression analysis, a sub group analysis with these variables was performed. In a subpopulation of females (n = 99), those receiving heparin treated circuits needed l ess blood products, had a lower incidence of rhythm disturbances and w ere extubated earlier than controls. In another subgroup of patients w ith aortic cross clamp time exceeding 60 min (n = 197), the amount of patients requiring prolonged intensive care treatment (> 24 h) was sig nificantly lower when they received heparin treated circuits versus co ntrols. Conclusion: These findings suggest that improved recovery can be expected with heparin treated circuits in specific higher risk pati ent populations (e.g. females) and when prolonged aortic cross clamp t ime is anticipated. Further investigations are recommended to analyse the clinical benefit of heparin treated circuits in studies with patie nts in different well defined risk categories and under better standar dised circumstances. (C) 1997 Elsevier Science B.V.