title: Development of a small implantable right ventricular assist device.
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.
authors.affiliation: Department of Biomedical Engineering, Lerner Research Institute, The Cleveland Clinic Foundation, Cleveland, OH 44195, USA. fukamak@ccf.org
authors.forename: Kiyotaka
authors.initials: K
authors.lastname: Fukamachi
authors.forename: David J
authors.initials: DJ
authors.lastname: Horvath
authors.forename: Alex L
authors.initials: AL
authors.lastname: Massiello
authors.forename: Yoshio
authors.initials: Y
authors.lastname: Ootaki
authors.forename: Keiji
authors.initials: K
authors.lastname: Kamohara
authors.forename: Masatoshi
authors.initials: M
authors.lastname: Akiyama
authors.forename: Firas
authors.initials: F
authors.lastname: Zahr
authors.forename: Michael W
authors.initials: MW
authors.lastname: Kopcak
authors.forename: Raymond
authors.initials: R
authors.lastname: Dessoffy
authors.forename: Ji-Feng
authors.initials: JF
authors.lastname: Chen
authors.forename: Stephen
authors.initials: S
authors.lastname: Benefit
authors.forename: Leonard A R
authors.initials: LA
authors.lastname: Golding
mesh_terms: 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