title: Preclinical readiness testing of the Arrow International CorAide left ventricular assist system.
abstract: BACKGROUND
  Left ventricular assist system technologies are currently being developed as effective alternatives to cardiac transplantation. In this study, in vivo testing of the Arrow International CorAide left ventricular assist system was conducted to determine its preclinical readiness based on demonstrated system performance and biocompatibility.
  
  
  METHODS
  Arrow International CorAide blood pump assemblies were implanted in 7 calves for 1-month (n = 4) and 3-month (n = 3) durations without the use of chronic anticoagulation therapy. Hemodynamic performance, physiologic pump control, end-organ function, and device-related adverse events were evaluated during the studies and at autopsy.
  
  
  RESULTS
  Hemodynamics were stable in all cases with a mean pump flow of 4.1 +/- 0.8 L/min and a mean arterial pressure of 101 +/- 4 mm Hg. In all calves, renal and hepatic function remained normal with no incidence of hemolysis, infection, bleeding, or embolism. The CorAide physiologic control algorithm demonstrated appropriate pump speed and flow adjustments in response to physiologically induced inputs, and the system's external electronic components demonstrated no hardware or software malfunction. All 7 cases were sacrificed electively. Autopsy revealed no sign of end-organ disease on gross and histologic examinations, and no device failure, malfunction, or mechanical wear of the pump blood-bearing surfaces was found.
  
  
  CONCLUSIONS
  The Arrow CorAide left ventricular assist system demonstrated effective pump performance and good biocompatibility with no incidence of device-related adverse events. This system has completed its preclinical readiness testing and is approved for clinical trials in Europe in 2003.
authors.affiliation: Department of Biomedical Engineering, The Cleveland Clinic Foundation, Cleveland, Ohio 44195, USA.
authors.forename: Kazuyoshi
authors.initials: K
authors.lastname: Doi
authors.forename: Leonard A R
authors.initials: LA
authors.lastname: Golding
authors.forename: Alex L
authors.initials: AL
authors.lastname: Massiello
authors.forename: Michael W
authors.initials: MW
authors.lastname: Kopcak
authors.forename: Renee L
authors.initials: RL
authors.lastname: Gerhart
authors.forename: Soren
authors.initials: S
authors.lastname: Schenk
authors.forename: Masahiro
authors.initials: M
authors.lastname: Inoue
authors.forename: Yoshio
authors.initials: Y
authors.lastname: Ootaki
authors.forename: Kiyotaka
authors.initials: K
authors.lastname: Fukamachi
mesh_terms: D000818:Animals; D000925:Anticoagulants / Q000008:administration & dosage; D002417:Cattle; D004867:Equipment Design; D006353:Heart-Assist Devices / Q000009:adverse effects; D006400:Hematocrit; D006439:Hemodynamics; D006454:Hemoglobins / Q000032:analysis; D008099:Liver / Q000502:physiology; D010976:Platelet Count
chemical_list: D000925:Anticoagulants; D006454:Hemoglobins