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Centrifugal blood pumps are playing a key role in circulatory mechanical assist systems including cardiopulmonary bypass (CPB), right and left ventricular assist devices (RVAD and LVAD), percutaneous cardiopulmonary support (PCPS), and extracorporeal membrane oxygenation (ECMO). Each of these circulatory assist systems requires specific flow and pressure conditions. In vitro hemolysis tests were performed using five compact mock loops with flow and pressure set equivalent to clinical conditions. These studies determined the hemolytic characteristics and clinical applicability of the pivot bearing-supported Gyro centrifugal pump with an eccentric port (C1E3) compared with the Bio-Medicus pump (BP-80). Normalized index of hemolysis (NIH) values of the C1E3 were less than those of the BP-80 under all conditions; in particular, they were significantly less in the CPB, LVAD, and RVAD conditions. In addition, linear correlation was observed between NIH values, rotational pump speed (RPM), total pressure head (delta P), and flow rate (Q) with both the C1E3 and BP-80: NIH = a(RPM/Q) + b, NIH = c(delta P/Q) + d. However, the slopes (a and c) of these equations were smaller with the C1E3 than those with the BP-80, which suggests that the C1E3 has decreased hemolytic characteristics when increasing the RPM and delta P. In other words, the increase of RPM and delta P results in less shear stress with the C1E3 than with the BP-80. One cause of these decreased hemolytic characteristics of the C1E3 is thought to be less pump power loss against an increase of RPM and delta P than with the BP-80. Furthermore, the average exposure time is shorter with the C1E3 than with the BP-80 because the priming volume of the C1E3 (30 ml) is smaller than that of the BP-80 (80 ml). From the point of both shear stress and exposure time, the C1E3 has less hemolytic features than the BP-80.

CABG is superior for revascularization in dialysis patients compared with PCI using DES in terms of freedom from cardiac-related events.

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The double pivot bearings in the Gyro C1E3 centrifugal blood pump incorporate a high-purity alumina (Al2O3) ceramic and an ultra-high-molecular-weight polyethylene (UHMWPE). This centrifugal pump has been developed as a completely sealless pump for long-term usage. The combination of Al2O3 and UHMWPE are the materials of choice for the acetabular bearing in artificial joints, which have proven to be clinically reliable for over 10 years. Previous studies have examined the biocompatibility of Al2O3 and UHMWPE as bulky implant materials. The present study investigated this material as a blood-contacting material using a standard assessment in vitro and in vivo analysis. The examined items were systemic toxicity, sensitization (guinea pig maximization test), cytotoxicity (elution test), mutagenicity (Ames test), direct contact hemolysis, and thrombogenicity. The studies were performed according to the United States Pharmacopoeia and published previous studies. The samples of both Al2O3 and UHMWPE demonstrated no differences from the negative controls in all tests. These findings indicate that both Al2O3 and UHMWPE are biocompatible materials for double-pivot bearings in the centrifugal blood pump.