Downsizing of a Pulsatile Total Artificial Heart-The Effect on Hemolysis

A downsized version of the ReinHeart total artificial heart (TAH) was developed. Hemocompatibility needs to be revised since the operating point of the downsized TAH has changed to a higher pump frequency to accomplish the same cardiac output. A mock circulation loop was designed, containing a left side for hemocompatibility testing and a right side to mimic realistic work conditions. A protocol for hemolysis testing was established using pooled porcine blood with an operation point of 5 L/min, a mean outlet pressure of 100 mm Hg and a mean inlet pressure of 12 mm Hg. Six trials were performed testing two downsized TAH (one with a compliance chamber [CC] connected, necessary for a pneumatic decoupling of both membranes and one open to atmosphere) and a BPX-80 as reference pump. The average modified index of hemolysis and normalized index of hemolysis (NIH in mg/100L) from six individual trials of the reference pump were 0.34 (0.07) and 3.21 (0.61) and of the TAH open to atmosphere 4.18 (1.19) and 38.85 (10.59), respectively. In between TAH with and without CC, there was no significant difference. A NIH ratio of TAH and reference pump was calculated to minimize variation of the different blood batches used in individual trials. Due to the downsizing, the ReinHeart's hemolysis level increased by around 22% compared with the original size version. Comparing the results to clinically approved left ventricular assist devices, the level of hemolysis can still be considered acceptable.

Automated summary

A downsized version of the ReinHeart total artificial heart was developed and tested for hemocompatibility. The hemolysis level increased by approximately 22% compared to the original size version, but it can still be considered acceptable.