Clinical Performance and Biocompatibility of Novel Hyaluronan-Based Heparin-Bonded Extracorporeal Circuits

Abstract

We tested documented in vitro and ex vivo advantages of novel hyaluronan based heparin bonded extracorporeal circuits in a prospective randomized study. During the period from June until September 2005, 40 patients undergoing reoperation for coronary artery bypass grafting were allocated into two equal groups (n= 20): Group 1 was treated with hyaluronan-based heparin-bonded circuits and group 2 was treated with uncoated control circuits. Complete blood count, fibrinogen, albumin, C3a, interleukin-2 levels, and thromboelastographic data were documented after induction of anesthesia (T1) and heparin administration before cardiopulmonary bypass (CPB) (T2), 15 minutes after initiation of CPB (T3), before cessation of CPB (T4), 15 minutes after reversal with protamine (T5), and the first postoperative day at 8:00 a.m. (T6). Hollow fibers were collected for consecutive biomaterial analysis by optical and scanning electron microscopy (SEM). Desorbed protein deposition on fibers was compared by spectrophotometry. Leukocyte counts were lower in T4-T6 in group 1 (p< .05). Platelet counts demonstrated significant differences at T4 and T5 in coated group (p< .05). Albumin and fibrinogen levels were better preserved in Group 1 at T4, T5 and T4, T6, consecutively (p< .05). C3a and IL-2 levels were lower at T3-T5 and T4-T5 in intervention group (p< .05). Postoperative hemorrhage was 412 ± 50 mL in group 1 and 684 ± 50 ml in group 2 (p< .05). Respiratory support time was shorter in group 1 versus control (p< .05). Platelet adhesion was significantly lower in intervention group. Amount of desorbed protein was 1.44 ± 0.01 mg/dL in group 1 and 1.94 ± 0.01 mg/dL in control (p< .05). SEM and spectrophotometry demonstrated better surface preservation in the hyaluronan coated group. Novel hyaluronan-based heparin-bonded circuits reduce platelet adhesion-aggregation and protein adsorption and provide better perioperative clinical parameters through platelet, albumin, and fibrinogen-sparing effects.