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Downsizing of a Pulsatile Total Artificial Heart-The Effect on Hemolysis
Moritz K Brockhaus1, Stephan Hildebrand1, Mario Diedrich1
1Department of Cardiovascular Engineering, Institute of Applied Medical Engineering, Medical Faculty, RWTH Aachen University, Aachen, Germany.
ASAIO Journal (American Society for Artificial Internal Organs : 1992)
|March 26, 2021
Summary
Downsizing the ReinHeart total artificial heart (TAH) increased hemolysis by 22%. However, the hemolysis levels remain acceptable when compared to other clinical ventricular assist devices.
Area of Science:
- Biomedical Engineering
- Cardiovascular Research
- Medical Device Development
Background:
- A downsized ReinHeart total artificial heart (TAH) was developed, necessitating a reassessment of its hemocompatibility.
- Increased pump frequency in the downsized TAH impacts operating parameters and requires hemocompatibility evaluation.
Purpose of the Study:
- To evaluate the hemocompatibility, specifically hemolysis, of a downsized ReinHeart TAH.
- To compare hemolysis levels of the downsized TAH against a reference pump and original version.
Main Methods:
- A mock circulation loop simulating physiological conditions was used for testing.
- Hemolysis was quantified using pooled porcine blood and a standardized protocol, measuring the normalized index of hemolysis (NIH).
- The downsized TAH was tested with and without a compliance chamber (CC), alongside a BPX-80 reference pump.
Main Results:
- The downsized TAH exhibited a 22% increase in hemolysis compared to its original version.
- The normalized index of hemolysis (NIH) for the TAH (open to atmosphere) was 38.85 (10.59) mg/100L, significantly higher than the reference pump's 3.21 (0.61) mg/100L.
- No significant difference in hemolysis was observed between the TAH with and without a compliance chamber.
Conclusions:
- Despite increased hemolysis due to downsizing, the ReinHeart TAH's levels are comparable to clinically approved ventricular assist devices.
- Further hemocompatibility assessments may be needed, but initial results suggest acceptable performance for the downsized TAH.
