Development of a small implantable right ventricular assist device.
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.
Fukamachi
Kiyotaka
K
Department of Biomedical Engineering, Lerner Research Institute, The Cleveland Clinic Foundation, Cleveland, OH 44195, USA. fukamak@ccf.org
Horvath
David J
DJ
Massiello
Alex L
AL
Ootaki
Yoshio
Y
Kamohara
Keiji
K
Akiyama
Masatoshi
M
Zahr
Firas
F
Kopcak
Michael W
MW
Dessoffy
Raymond
R
Chen
Ji-Feng
JF
Benefit
Stephen
S
Golding
Leonard A R
LA
D001698:Biomedical Engineering; D006333:Heart Failure / Q000503:physiopathology / Q000601:surgery / Q000628:therapy; D006352:Heart Ventricles / Q000503:physiopathology / Q000601:surgery; D006353:Heart-Assist Devices; D006801:Humans; D066298:In Vitro Techniques; D011474:Prosthesis Design