CLINICAL-EVALUATION OF A SILICONE COATED HOLLOW-FIBER OXYGENATOR

in this article, the clinical experience with a cardiopulmonary bypass (CPB) using a newly developed hollow fiber oxygenator with an ultra-t hin layer of silicone is reported. A comparative study of biocompatibi lity between the new oxygenator and a heparin coated oxygenator is als o described. The CPB was performed with a silicone coated oxygenator, Mera Excelung Binding Prim HPO 15 H-C(R) (Group I, n = 6) or Binding P rim HPO 25 H-C(R) (Group II, n = 10) (Senko Medical Instrument Mg., To kyo, Japan). Air could be vented through the silicone coated hollow fi bers, and it was easy to prime the circuits. The CPB duration was 101 +/- 37 min and 170 +/- 64 min for Groups I and II, respectively. There were no deaths and no complications from CPB. Partial arterial pressu re of O-2 levels 60 minutes after the start of CPB were 529 +/- 28 mm Hg and 529 +/- 28 mmHg for Group I and II, respectively. Partial arter ial pressure of CO2 levels 60 min after the start of CPB were 36.4 +/- 4.6 mmHg and 39.4 +/- 4.4 mmHg, respectively. Plasma free hemoglobin at 60 min was 33.5 +/- 17.2 mg/dL and 46.7 +/- 26.1 mg/dL for Groups I and II, respectively. As an evaluation of biocompatibility, the effec ts of the new oxygenator on platelet activation (GP Ib, IIb/IIIa), coa gulation (TAT), fibrinolysis (PIC), and inflammatory response (C3a, gr anulocyte elastase) were investigated during CPB and comparing to thos e of the heparin coated oxygenator. There were no significant differen ces in CP Ib, CIP IIb/IIa, TAT, PIC, and granulocyte elastase between the two oxygenators. However, 60 min after the start of CPB, the C3a w as significantly lower for the new oxygenator group than for the hepar in coated oxygenator group (p < 0.03). The new oxygenator showed good gas transfer, low hemolysis, and good biocompatibility. Because of its durability and good biocompatibility, the new oxygenator was determin ed to be suitable for prolonged extra corporeal circulation.