In Vitro Hemolytic Performance of the Realheart® V11C TAH Prototype with Porcine Blood.

Abstract

Hemolysis testing of new devices to treat heart failure is a regulatory requirement. The ASTM F1841-97 standard for hemolysis testing was developed for continuous flow pumps and does not specify test rig design. When research groups use different methodologies, results are difficult to compare. Pulsatile flow pump rigs require compliance chambers, thus the Aachen rig (Gräf et al) was developed for the pulsatile Reinheart TAH. The study objective was to use this rig to test the early Realheart TAH prototype V11C hemolysis performance compared to literature. The experimental control was the continuous flow pump BPX-80 (Medtronic) and pooled heparinized porcine blood was used. The mgNIH of BPX-80 and V11C was 5.42 ± 1.47 and 25.20 ± 5.46 mg/100 L, respectively. The NIH ratio of V11C over BPX-80 was 5.5. The absolute and the relative hemolysis of the V11C are lower compared to both the large and small Reinheart TAH devices published values. Pulsatile pumps create more hemolysis in the Aachen rig, and it is not known if this is because how the rig handles pulsatile flow or due to the devices. Future studies will therefore use a pulsatile pump such as the SynCardia as clinical comparator and human blood to test the performance of future Realheart TAH prototypes.