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Progress in Cleveland Clinic-Nimbus total artificial heart development
H Harasaki1, K Fukamachi, A Massiello
1Department of Biomedical Engineering, Cleveland Clinic Foundation, OH 44195, USA.
ASAIO Journal (American Society for Artificial Internal Organs : 1992)
|July 1, 1994
Summary
The Cleveland Clinic-Nimbus total artificial heart (TAH) shows promising results in calf implants, maintaining organ function and demonstrating good biocompatibility. Further development is needed to address rare embolism complications.
Area of Science:
- Biomedical Engineering
- Cardiovascular Surgery
- Implantable Devices
Background:
- Total artificial hearts (TAHs) are crucial for end-stage heart failure treatment.
- The Cleveland Clinic-Nimbus TAH utilizes electrohydraulic energy conversion and an advanced control scheme.
- Previous TAH designs faced challenges with biocompatibility and energy transmission.
Purpose of the Study:
- To evaluate the performance and biocompatibility of the Cleveland Clinic-Nimbus TAH in a pre-clinical animal model.
- To assess the long-term function of major organs and blood cell parameters during TAH support.
- To investigate the efficacy of the transcutaneous energy transmission system and internal battery.
Main Methods:
- Implantation of the Cleveland Clinic-Nimbus TAH in 12 calves for durations of 1-120 days.
- Monitoring of major organ function, blood cell counts, and platelet aggregation.
- Assessment of pump surface cleanliness, infection, and embolism incidence.
- Evaluation of tissue compatibility, device temperature, and energy system performance.
Main Results:
- Normal major organ and blood cell function were maintained throughout the study period.
- Platelet aggregation recovery observed by the second post-operative week.
- Gelatin-coated pump surfaces remained clean, free from anticoagulants and infection in most cases.
- Two embolism cases were linked to fungal infection and thrombus formation.
- Hybridized microcircuit controller demonstrated successful function with minimal localized heat elevation (peak 6.5°C).
- Carbon fiber-reinforced epoxy housing and compliance chamber exhibited good tissue compatibility.
- Transcutaneous energy transmission and internal battery systems performed as designed.
Conclusions:
- The Cleveland Clinic-Nimbus TAH demonstrates good biocompatibility and maintains physiological function in a pre-clinical setting.
- The device's energy systems and control scheme are effective.
- Further investigation is warranted to mitigate rare embolism risks associated with TAH implantation.