Evaluation of the bio-compatablity and clinical usefulness of an ultra-thin silicone-coated polypropylene hollow-fiber oxygenator.

Abstract

Purpose: A new membrane oxygenator consisting of microporous polypropylene hollow fibers coated with an ultra-thin layer of silicone was developed, we have already reported that this new oxygenator maintains good gas transfer and shows good durability in animal models. We studied the biocompatablity and clinical usefulness of this ultra-thin silicone-coated polypropylene hollow fiber oxygenator. Materials and methods: To evaluate clinical usefulness of the new oxygenator, 22 patients underwent cardiopulmonary bypass(CPB) with the silicone-coated oxygenator. Plasma free Hb, platelet count, thrombin-antithrombin III complex(TAT), α 2 plasmin inhibitor-plasmin complex(PIC), and granulocyte elastase were investigated during CPB in 10 patients(Group S) compared with those in 10 patients managed with a standerd heparin-coated oxygenator(Group H). Results: Blood gas analyses revealed that high PO₂ and acceptable PCO₂ levels were maintained during CPB. Air could be vented through the silicone-coated hollow fibers and the circuits were easy to prime. There were ho significant differences between Group S and Group H in plasma free Hb, platelet count, TAT, PIC, or granulocyte elastase levels. Conclusions: These results suggest that this new oxygenator maintains good gas transfer and shows good biocompatibility under clinical conditions.