A prospective randomized trial of Duraflo II heparin-coated circuits in cardiac reoperations

Background. Heparin-coated circuits in cardiopulmonary bypass have been shown to decrease the systemic inflammatory responses associated with cardiopulmonary bypass. Previous clinical studies on low-risk patients who had coronary artery bypass grafting (CABG) and received full-dose systemic heparin did not have clearly improved clinical outcomes. We hypothesized that the beneficial effects of heparin-coated circuits might be seen in patients who had cardiac reoperations. Methods. Three hundred fifty patients who had reoperation with CABG only (58%), or with valve operations (42%) were randomly assigned to receive either a heparin-coated (Duraflo II; study group) or uncoated (control group) circuit. Clinical outcomes were compared and the variables were analyzed using the following three groups: entire populations of study group and control group, subgroup of patients who had CABG reoperation only, and a subgroup who had valve reoperation or combined valve and CABG reoperation. Results. Preoperative variables were the same in both groups. No difference in clinical outcomes could be demonstrated except that the percentage of patients with major bleeding episodes was significantly lower in the study group (1.2% versus 5.4%, p = 0.035). In the subgroup analysis of patients who had valve reoperations, lower blood transfusion requirements in the intensive care unit (p = 0.013) were found in the study group. When the subgroup of patients who had CABG reoperations was analyzed separately, there was a trend toward less reoperation for bleeding in the study group (0% versus 4.0%, p = 0.058). Conclusions. We conclude that the use of heparin-coated circuits was safe and imparted protection from reoperations for bleeding and major bleeding episodes. Material-independent blood activation (eg, blood-air interface and cardiotomy suction) blunted the total effect of the heparin-coated surface.