Clinical Evaluation of the Terumo Capiox ® FX05 Hollow Fiber Oxygenator with Integrated Arterial Line Filter

Abstract

Perfusion techniques and equipment in pediatric open heart surgery have continued to focus on decreasing prime volumes and lowering surface areas of the cardiopulmonary bypass circuit. While this has improved drastically over the last 20 years, greater demand is being placed on the perfusionist to reduce the deleterious effects of bypass without compromising safety or efficiency. Specifically, manufacturers of disposable perfusion equipment have focused on providing pediatric perfusionists with oxygenators that provide the smallest prime and surface area possible while attempting to maximize performance. Recently,Terumo Cardiovascular has introduced the Capiox® FX05, a neonatal hollow fiber oxygenator that includes an integrated arterial line filter. The FX05 provides a blood flow range of 0.1–1.5 L/min and a low priming volume of 43 mL. Additionally, it is coated with X Coating”, a biocompatible, hydrophilic polymer surface coating that reduces platelet adhesion and protein denaturation. The purpose of this study was to test the FX05 for gas transfer, blood path resistance, and blood handling characteristics in a standardized clinical setting. Heat exchange coefficients were also calculated during the cooling and warming period. Other data analyzed includes bypass circuit prime volumes and initial patient hematocrit along with the total operative homologous blood donor exposures. In summary, the FX05 offers good gas exchange capabilities and a low pressure drop during normal cardiopulmonary bypass parameters along with the safety of an integrated arterial line filter. Furthermore, the FX05 with integrated filter allows a reduction in overall bypass prime volume and surface area while promoting the reduction of homologous blood transfusions, optimizing hemostasis.