title: Development of DexAide right ventricular assist device: update II.
abstract: The DexAide right ventricular assist device (RVAD) is a magnetically and hydrodynamically levitated implantable centrifugal pump. Recent progress includes 1) redesign of the inflow/outflow conduits, which yielded two successful 3-month experiments, 2) development of alternative journal bearing materials, and 3) completion of an 18-month duration of in vitro endurance testing. Verification testing of the RVAD electronics has been completed, and a prototype biventricular assist device (BVAD) system has been tested. Acute DexAide/CorAide BVAD implantations via median sternotomy in two calves documented BVAD control algorithms and anatomical fit. A drug-induced chronic calf heart failure model, currently under development in our laboratory, resulted in a successful BVAD implantation in a calf with heart failure. Our future plans are to complete in vitro and in vivo validation of alternative bearing materials, perform preclinical DexAide in vivo and in vitro reliability studies, and obtain Food and Drug Administration (FDA) approval for an Investigational Device Exemption to conduct a clinical pilot study. In conclusion, two successful 3 month in vivo experiments and an 18-month in vitro endurance test were completed. After final bearing material selection, the DexAide design will be "frozen" so that preclinical systems can be manufactured. BVAD experiments using a chronic heart failure model are in progress.
authors.affiliation: Department of Biomedical Engineering, Lerner Research Institute, Cleveland Clinic, Cleveland, Ohio 44195, USA.
authors.forename: Kiyotaka
authors.initials: K
authors.lastname: Fukamachi
authors.forename: Diyar
authors.initials: D
authors.lastname: Saeed
authors.forename: Alex L
authors.initials: AL
authors.lastname: Massiello
authors.forename: David J
authors.initials: DJ
authors.lastname: Horvath
authors.forename: Hideyuki
authors.initials: H
authors.lastname: Fumoto
authors.forename: Tetsuya
authors.initials: T
authors.lastname: Horai
authors.forename: Roula
authors.initials: R
authors.lastname: Zahr
authors.forename: Shanaz
authors.initials: S
authors.lastname: Shalli
authors.forename: Tomohiro
authors.initials: T
authors.lastname: Anzai
authors.forename: Raymond
authors.initials: R
authors.lastname: Dessoffy
authors.forename: Jacquelyn
authors.initials: J
authors.lastname: Catanese
authors.forename: Ji-Feng
authors.initials: JF
authors.lastname: Chen
authors.forename: Qun
authors.initials: Q
authors.lastname: Zhou
authors.forename: Stephen
authors.initials: S
authors.lastname: Benefit
authors.forename: Sue
authors.initials: S
authors.lastname: Alfini
authors.forename: Leonard A R
authors.initials: LA
authors.lastname: Golding
mesh_terms: D000465:Algorithms; D000818:Animals; D002417:Cattle; D004195:Disease Models, Animal; D004867:Equipment Design; D006333:Heart Failure / Q000628:therapy*; D006353:Heart-Assist Devices; D006439:Hemodynamics