title: In vivo evaluation of the HeartWare centrifugal ventricular assist device.
abstract: In this study, long-term (90-day) hemocompatibility and end-organ effects of a centrifugal left ventricular assist device (the Heartware HVAD) were evaluated in 6 healthy sheep. The device was implanted into the left ventricular apex on beating hearts. The outflow graft of each device was anastomosed to the descending aorta. None of the sheep received anticoagulation or antiaggregation medication during the study. Hematologic and biochemical tests of liver and kidney function were performed pre-operatively (baseline) and throughout the study. Data associated with pump function were collected continuously until 90 +/- 1 days of support, at which time the sheep were humanely killed, and the end-organs were examined macroscopically and histopathologically. Hematologic and biochemical test results were within normal limits during the study period. There were no significant complications. Postmortem examination of the explanted organs revealed no evidence of ischemia or infarction, except in 2 sheep, in which small foci of infarction were detected in each of their left kidneys. There was no significant device failure. In all sheep, the pump's inflow and outflow conduits were free of thrombus. During the 90-day study, the HeartWare HVAD showed exceptional hemocompatibility and reliability, both of which are crucial to the clinical success of any implantable left ventricular assist device.
authors.affiliation: Cardiovascular Surgical Research Laboratories, Texas Heart Institute at St. Luke's Episcopal Hospital, Houston, Texas 77030, USA. etuzun@heart.thi.tmc.edu
authors.forename: Egemen
authors.initials: E
authors.lastname: Tuzun
authors.forename: Katy
authors.initials: K
authors.lastname: Roberts
authors.forename: William E
authors.initials: WE
authors.lastname: Cohn
authors.forename: Murat
authors.initials: M
authors.lastname: Sargin
authors.forename: Courtney J
authors.initials: CJ
authors.lastname: Gemmato
authors.forename: Branislav
authors.initials: B
authors.lastname: Radovancevic
authors.forename: O H
authors.initials: OH
authors.lastname: Frazier
mesh_terms: D000818:Animals; D001672:Biocompatible Materials; D004195:Disease Models, Animal; D004906:Erythrocyte Count; D005500:Follow-Up Studies; D006333:Heart Failure / Q000097:blood / Q000601:surgery*; D006352:Heart Ventricles / Q000473:pathology; D006353:Heart-Assist Devices; D006400:Hematocrit; D011474:Prosthesis Design; D019919:Prosthesis Implantation / Q000295:instrumentation*; D015203:Reproducibility of Results; D012756:Sheep
chemical_list: D001672:Biocompatible Materials