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Development of a small implantable right ventricular assist device
Kiyotaka Fukamachi1, David J Horvath, Alex L Massiello
1Department of Biomedical Engineering, Lerner Research Institute, The Cleveland Clinic Foundation, Cleveland, OH 44195, USA. fukamak@ccf.org
ASAIO Journal (American Society for Artificial Internal Organs : 1992)
|December 13, 2005
Summary
Researchers developed the DexAide, a new implantable right ventricular assist device (RVAD) for severe heart failure. Initial tests show the RVAD meets performance requirements for clinical use.
Area of Science:
- Biomedical Engineering
- Cardiovascular Devices
- Medical Technology
Background:
- Severe biventricular heart failure necessitates advanced circulatory support.
- Current biventricular assist devices require further optimization for specific ventricular support.
- Implantable assist devices offer a promising solution for long-term cardiac function restoration.
Purpose of the Study:
- To design, develop, and evaluate a novel implantable right ventricular assist device (RVAD).
- To create an RVAD component for biventricular assist devices in patients with severe biventricular heart failure.
- To assess the performance of the prototype RVAD, named DexAide.
Main Methods:
- In vitro testing of the DexAide RVAD in stand-alone and true RVAD configurations.
- Evaluation of pump performance, including flow rate and power consumption, under varied conditions.
- Measurement of pump flow against different afterloads and pump speeds.
Main Results:
- The DexAide RVAD prototype successfully met performance criteria.
- Achieved pump flow rates of 2 to 6 L/min and pressure rise of 20 to 60 mm Hg at speeds of 1,800–3,200 rpm.
- Nominal design point of 4 L/min and 40 mm Hg pressure rise achieved at 2,450 rpm with 3.0 W power consumption.
Conclusions:
- Initial in vitro testing confirmed the DexAide RVAD meets design specifications.
- The DexAide RVAD is a viable candidate for further development and clinical evaluation.
- The device is progressing towards in vivo testing, preclinical readiness, and a pilot clinical trial.