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A miniature implantable axial flow ventricular assist device.
1DeBakey Heart Center, Department of Surgery, Baylor College of Medicine, Houston, Texas 77030, USA.
The Annals of Thoracic Surgery
|September 4, 1999
Summary
This study presents a novel axial flow pump, demonstrating excellent performance and biocompatibility in a calf model. The device achieved a consistent 5 L/min output with no thromboembolism, indicating its potential for clinical use.
Area of Science:
- Biomedical Engineering
- Cardiovascular Devices
- Surgical Technology
Background:
- Development of a compact axial flow pump (86 mm length, 22 mm width, 95 g) in collaboration with NASA engineers.
- Pump specifications: 5-6 L/min flow against 100-mm Hg pressure, ~10,000 rpm, <10 W power consumption.
Purpose of the Study:
- To evaluate the performance and biocompatibility of a novel axial flow pump in a large animal model.
- To assess the pump's efficacy and safety for potential clinical application in cardiovascular support.
Main Methods:
- Implantation of the axial flow pump in 9 calves, with left ventricular inflow and descending thoracic aorta outflow via a Dacron graft.
- Monitoring of pump performance, physiological parameters, and systemic organ health for 1-3 months post-operation.
Main Results:
- Sustained pump operation (9,000-10,000 rpm, 7-9 W, 4-5 L/min output) in all animals for up to 3 months.
- Absence of thromboembolism and hemolysis (plasma-free hemoglobin 0.5-3 mg/dL) observed at autopsy.
- Normal physiological parameters (hemoglobin, BUN, creatinine, bilirubin) and negative bearing wear-tear tests.
Conclusions:
- The axial flow pump demonstrates highly gratifying performance characteristics in a calf model up to 90 days.
- Key indicators of success include consistent pump output (5 L/min), hemolysis within normal limits, and a complete absence of thromboembolism.
- The findings support the potential clinical utility of this device for cardiovascular support.