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Comparative Study
. 2005 Nov-Dec;51(6):730-5.
doi: 10.1097/01.mat.0000181031.66900.b6.

Development of a small implantable right ventricular assist device

Kiyotaka Fukamachi  1 , David J Horvath, Alex L Massiello, Yoshio Ootaki, Keiji Kamohara, Masatoshi Akiyama, Firas Zahr, Michael W Kopcak Jr, Raymond Dessoffy, Ji-Feng Chen, Stephen Benefit, Leonard A R Golding
Affiliations
Comparative Study

Development of a small implantable right ventricular assist device

Kiyotaka Fukamachi et al. ASAIO J. 2005 Nov-Dec.

Abstract

The purpose of this program is to design, develop, and clinically evaluate a new, implantable right ventricular assist device (RVAD) that can be used as a component of an implantable biventricular assist device for patients with severe biventricular heart failure. The initial phase of this program resulted in a prototype RVAD, named DexAide, a modified version of the CorAide left ventricular assist device. In vitro testing was performed in a stand-alone circuit and in a true RVAD mode to evaluate pump performance. Pump flow and power were measured under various afterload and pump speed conditions. The pump performance requirements of 2 to 6 l/min and a pressure rise of 20 to 60 mm Hg were successfully met with pump speeds between 1,800 and 3,200 rpm. The nominal design point of 4 l/min and 40 mm Hg pressure rise was achieved at 2,450 +/- 70 rpm with a power consumption of 3.0 +/- 0.2 W. The initial in vitro testing met the design criteria for the new DexAide RVAD. Initial in vivo testing is under way, which will be followed by preclinical readiness testing and a pilot clinical trial in this 5-year program.

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Figures

Figure 1
Figure 1
A comparison of the CorAide™ LVAD (Left) and DexAide RVAD (Right). Both pumps consist of three sub-assemblies: the volute housing, the rotating assembly, and the stator assembly (from top to bottom).
Figure 2
Figure 2
Schematic drawings of nonpulsatile and pulsatile mock circulatory systems. F: DexAide pump flow, Pin: Inlet pressure, Pout: Outlet pressure, VAD: ventricular assist device.
Figure 3
Figure 3
Pressure rise vs. pump flow relationship under various pump speeds. The shaded area shows our target operating range. The upward bars indicate standard deviation.
Figure 4
Figure 4
Pump power vs. pump flow relationship with various pump speeds. The upward bars indicate standard deviation.
Figure 5
Figure 5
Normalized pump power vs. pump flow relationship under various pump speeds. The upward bars indicate standard deviation.
Figure 6
Figure 6
Pump efficiency vs. pump flow relationship under various pump speeds. The upward bars indicate standard deviation.
Figure 7
Figure 7
Instantaneous relationship between pressure rise vs. pump flow (thin line) in the pulsatile mock circulatory system with a DexAide pump speed set at 2,400 rpm and a pneumatic VAD beat rate set at 70 bpm. The mean pressure rise vs. mean pump flow data in the pulsatile mock circulatory system is plotted as a closed circle. The data in the nonpulsatile circulatory system with the DexAide pump speed of 2,400 rpm are also plotted (thick line) for comparison.
Figure 8
Figure 8
Instantaneous relationship between pressure rise vs. pump flow (thin line) in the pulsatile mock circulatory system with the DexAide pump speed set at 2,400 and the pneumatic VAD beat rate set at 120 bpm. The mean pressure rise vs. mean pump flow data in the pulsatile mock circulatory system is plotted as a closed circle. The data in the nonpulsatile circulatory system with the DexAide pump speed of 2,400 are also plotted (thick line) for comparison.
Figure 9
Figure 9
Percutaneous BVAD with CorAide LVAD and DexAide RVAD.
See this image and copyright information in PMC

References

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