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Despite improved hemocompatibility of left-ventricular assist devices (LVADs), assessment of blood damage remains mandatory in preclinical testing as standardized by ASTM-F1841. The most relevant test fluid is fresh, non-pooled human blood, but the limited volume of a standard donation requires significantly smaller loops than those commonly used with animal blood. In a recent study with porcine blood, we verified a miniaturized test loop with only 160 mL for the ASTM-conform paired testing of at least two LVADs and a static reference. Here, we validated this mini test loop for standardized assessment of blood damage with one 450-mL single donation of fresh human blood. Blood damage was assessed for HeartMate 3 and BPX-80 in 9 experiments with heparinized human blood for 6 hours. We analyzed plasma free hemoglobin, von Willebrand factor (vWF) concentration and collagen-binding functionality and calculated indices of hemolysis and vWF-ratios. Overall, we observed less blood damage compared to our previous study; however, the differences in mean indices of hemolysis and in mean normalized vWF-ratio between BPX-80 and HeartMate 3 were consistent for human blood. Thus, our mini test loop proved to be valid for preclinical standardized assessment of blood damage with only 450 mL of fresh human blood.

Validation of a Miniaturized Test Loop for the Assessment of Human Blood Damage by Continuous-Flow Left-Ventricular Assist Devices