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HeartMate II left ventricular assist system: from concept to first clinical use
B P Griffith1, R L Kormos, H S Borovetz
1Division of Cardiovascular Surgery, University of Pittsburgh Medical Center, Pennsylvania 15213, USA. griffithbp@msx.upmc.edu
The Annals of Thoracic Surgery
|March 27, 2001
Summary
The HeartMate II left ventricular assist device (LVAD) has undergone significant development since 1991. This advanced pump technology is now entering human trials for end-stage heart failure patients.
Area of Science:
- Cardiovascular Engineering
- Biomedical Devices
- Medical Technology
Background:
- The HeartMate II left ventricular assist device (LVAD) originated from a partnership between the University of Pittsburgh and Nimbus Company in 1991.
- Early designs were based on axial-flow mini-pumps and incorporated purge bearings.
- Advancements in bearing technology, computational fluid dynamics, flow visualization, and speed control algorithms have been integral to its development.
Purpose of the Study:
- To detail the developmental evolution of the HeartMate II left ventricular assist device (LVAD).
- To highlight key technological advancements contributing to the LVAD's progress.
- To outline the transition from preclinical testing to human clinical trials.
Main Methods:
- Conceptualization based on axial-flow mini-pumps (Hemopump).
- Incorporation of advanced bearing technologies and computational fluid dynamics.
- Extensive preclinical testing in over 40 calves since 1997.
- Development of improved cannulas, controllers, and power/monitor units.
Main Results:
- Successful preclinical testing in over 40 calves.
- First human implantation occurred in July 2000.
- The device has undergone significant technological refinement.
Conclusions:
- The HeartMate II LVAD represents a culmination of over a decade of research and development.
- The device is progressing towards multicenter safety and feasibility trials in Europe and the United States.
- These trials aim to evaluate 6-month survival rates in patients with end-stage heart failure.
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