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A biolized, compact, low noise, high performance implantable electromechanical ventricular assist system.
T Sasaki1, S Takatani, M Shiono
1Department of Surgery, Baylor College of Medicine, Houston, Texas 77030.
ASAIO Transactions
|July 1, 1991
Summary
A new implantable electromechanical ventricular assist system (VAS) demonstrated successful function in calf studies, showing excellent biocompatibility and no thromboembolic complications without anticoagulation.
Area of Science:
- Biomedical Engineering
- Cardiovascular Devices
- Implantable Technology
Background:
- Heart failure necessitates advanced mechanical circulatory support.
- Existing ventricular assist systems face challenges with size, biocompatibility, and thromboembolic events.
Purpose of the Study:
- To develop and evaluate a novel implantable electromechanical ventricular assist system (VAS) for permanent human use.
- To assess the device's performance, biocompatibility, and safety in preclinical studies.
Main Methods:
- A compact electromechanical ventricular assist system (VAS) with a 63 ml stroke volume was designed.
- The device featured a polyolefin diaphragm, brushless motor, and dry gelatin coating for biocompatibility.
- Subacute calf studies (2 and 6 days) were performed to evaluate device fit and function.
Main Results:
- The VAS demonstrated satisfactory function in both fill-empty and fixed-rate modes within calf thoracic anatomy.
- No thromboembolic complications occurred despite the absence of anticoagulation therapy.
- The device is currently undergoing endurance testing exceeding 10 weeks (9 million cycles).
Conclusions:
- The developed electromechanical ventricular assist system (VAS) is compact, quiet, controllable, and exhibits excellent biocompatibility.
- Preclinical results suggest the VAS is a promising option for long-term cardiac support.
- Further evaluation is warranted to confirm its efficacy and safety for human implantation.