Evaluation of a new condensed extra-corporeal circuit for cardiac surgery: a prospective randomized clinical pilot study

Abstract

This prospective randomized clinical pilot study was conducted to evaluate a recently introduced reduced volume CPB system that is coated with the biopassive Xcoating. Twenty-two patients undergoing coronary artery bypass grafting (CABG) with cardiopulmonary bypass (CPB), either with a fully heparin-coated CPB circuit (control, n=11) or with an Xcoating coated condensed extra-corporeal circuit (CondECC, n=11), were included. We examined activation of the complement system (C3bc and C4bc), activation of neutrophils (BPI), the acute phase response (interleukin (IL)-6, and acute phase proteins (LBP, AGP, and CRP)), myocardial tissue injury (troponin T), hemolysis (free hemoglobin (FHb)), and clinical outcome parameters. Preoperative risk profiles were identical for both patient groups. All patients went through the procedure without major complications and were discharged from the hospital. FHb and BPI levels at the end of pump support (p < 0.01) and at 15 min after the administration of protamine (p < 0.05) were significantly higher in the control group. In addition, FHb levels were still significantly elevated upon arrival on the cardiothoracic intensive care unit (CICU) in the control group (p < 0.05). C3bc and C4bc, acute phase proteins, IL-6, and troponin T concentrations, and clinical outcome variables were identical in both patient groups. In conclusion, the evaluated condensed extracorporeal circuit is a flexible and multifunctional CPB sytem that offers safe procedures. Furthermore, the results indicate improved biocompatibility of this option for extracorporeal circulation.