Development of a Small, Implantable Right Ventricular Assist Device
Kiyotaka Fukamachi, MD, PhD, David J. Horvath, MSME, Alex L. Massiello, MEBME, Yoshio Ootaki, MD, PhD, Keiji Kamohara, MD, Masatoshi Akiyama, MD, PhD, Firas Zahr, MD, Michael W. Kopcak, Jr., BA, Raymond Dessoffy, AA, Ji-Feng Chen, BS, Stephen Benefit, AAS, and Leonard A.R. Golding, MD
Department of Biomedical Engineering, Lerner Research Institute, The Cleveland Clinic Foundation 9500 Euclid Avenue, Cleveland OH 44195
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 as well as 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 the 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 watts.
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.
Keywords: ventricular assist device, right ventricular failure, circulatory support
Source: ASAIO J. 2005; 51(6): 730–735