HEPARIN-COATED (CARMEDA) OXYGENATORS IN PEDIATRIC CARDIAC SURGERY

Abstract

Introduction. Heparin-coated cardiopulmonary bypass (CPB) circuits may decrease the inflammatory response and coagulopathy associated with CPB. [1] Membrane oxygenators comprise the vast majority of surface area in these circuits. We undertook a prospective, randomized, blinded, controlled study of clinical outcomes with heparin-coated (Carmeda) oxygenators in pediatric cardiac surgery. Methods. Following Institutional Review Board approval and informed parental consent, 43 pediatric patients (<21kg) undergoing hypothermic CPB were randomized in blinded fashion to two groups: heparin-coated (Carmeda, Medtronic, Inc., Anaheim, CA) and non-heparin-coated (Control) oxygenators. Data were analyzed using Fisher Exact test, comparison of proportions and Mann Whitney Rank Sum test. Results. 21 Control patients (7 ASD, 2 VSD, 12 complex) and 22 Carmeda patients (7 ASD, 2 VSD, 13 complex) comprised the analysis. No significant differences between Control and Carmeda patients were detected in a number of perioperative variables, as summarized in Table 1 below. Values are expressed either as percent of patients or mean +/- SD, except for chest tube output and ml/kg PRBC transfused (median, interquartile range).Table 1In addition, no significant differences between groups were detected for postoperative platelet count, PT, PTT or fibrinogen concentration. (Table 1 abbreviations: PRBC = packed red blood cells; FFP = fresh frozen plasma; pts = patients; A-a = alveolar - arterial.) Discussion. Heparin-coated (Carmeda) oxygenators did not lead to detectable differences in mediastinal drainage, allogeneic transfusion exposure, or postoperative pulmonary status in this blinded, controlled study of 43 pediatric cardiac surgery patients undergoing CPB.