title: First report of 90-day support of 2 calves with a continuous-flow total artificial heart.
abstract: OBJECTIVE
  The Cleveland Clinic continuous-flow total artificial heart (CFTAH) is a compact, single-piece, valveless, pulsatile pump providing self-regulated hemodynamic output to left/right circulation. We evaluated chronic in vivo pump performance, physiologic and hemodynamic parameters, and biocompatibility of the CFTAH in a well-established calf model.
  
  
  METHODS
  CFTAH pumps have been implanted in 17 calves total. Hemodynamic parameters, pump performance, and device-related adverse events were evaluated during studies and at necropsy.
  
  
  RESULTS
  In vivo experiments demonstrated good hemodynamic performance (pump flow, 7.3 ± 0.7 L/min; left atrial pressure, 16 ± 3 mm Hg; right atrial pressure, 17 ± 3 mm Hg; right atrial pressure-left atrial pressure difference, 1 ± 2 mm Hg; mean arterial pressure, 103 ± 7 mm Hg; arterial pulse pressure, 30 ± 11 mm Hg; and pulmonary arterial pressure, 34 ± 5 mm Hg). The CFTAH has operated within design specifications and never failed. With ever-improving pump design, the implants have shown no chronic hemolysis. Three animals with recent CFTAH implantation recovered well, with no postoperative anticoagulation, during planned in vivo durations of 30, 90, and 90 days (last 2 were intended to be 90-day studies). All these longest-surviving cases showed good biocompatibility, with no thromboembolism in organs.
  
  
  CONCLUSIONS
  The current CFTAH has demonstrated reliable self-regulation of hemodynamic output and acceptable biocompatibility without anticoagulation throughout 90 days of chronic implantation in calves. Meeting these milestones is in accord with our strategy to achieve transfer of this unique technology to human surgical practice, thus filling the urgent need for cardiac replacement devices as destination therapy.
authors.affiliation: Department of Biomedical Engineering, Lerner Research Institute, Cleveland Clinic, Cleveland, Ohio.
authors.forename: Jamshid H
authors.initials: JH
authors.lastname: Karimov
authors.affiliation: Department of Biomedical Engineering, Lerner Research Institute, Cleveland Clinic, Cleveland, Ohio; Department of Thoracic and Cardiovascular Surgery, Kaufman Center for Heart Failure, Cardiac Transplantation and Mechanical Circulatory Support, Miller Family Heart and Vascular Institute, Cleveland Clinic, Cleveland, Ohio.
authors.forename: Nader
authors.initials: N
authors.lastname: Moazami
authors.affiliation: Department of Biomedical Engineering, Lerner Research Institute, Cleveland Clinic, Cleveland, Ohio.
authors.forename: Mariko
authors.initials: M
authors.lastname: Kobayashi
authors.affiliation: Department of Cardiothoracic Anesthesiology, Anesthesiology Institute, Cleveland Clinic, Cleveland, Ohio.
authors.forename: Shiva
authors.initials: S
authors.lastname: Sale
authors.affiliation: Biological Resources Unit, Lerner Research Institute, Cleveland Clinic, Cleveland, Ohio.
authors.forename: Kimberly
authors.initials: K
authors.lastname: Such
authors.affiliation: Department of Biomedical Engineering, Lerner Research Institute, Cleveland Clinic, Cleveland, Ohio.
authors.forename: Nicole
authors.initials: N
authors.lastname: Byram
authors.affiliation: Department of Biomedical Engineering, Lerner Research Institute, Cleveland Clinic, Cleveland, Ohio.
authors.forename: Gengo
authors.initials: G
authors.lastname: Sunagawa
authors.affiliation: Department of Biomedical Engineering, Lerner Research Institute, Cleveland Clinic, Cleveland, Ohio.
authors.forename: David
authors.initials: D
authors.lastname: Horvath
authors.affiliation: Department of Biomedical Engineering, Lerner Research Institute, Cleveland Clinic, Cleveland, Ohio.
authors.forename: Shengqiang
authors.initials: S
authors.lastname: Gao
authors.affiliation: Department of Biomedical Engineering, Lerner Research Institute, Cleveland Clinic, Cleveland, Ohio.
authors.forename: Barry
authors.initials: B
authors.lastname: Kuban
authors.affiliation: Department of Biomedical Engineering, Lerner Research Institute, Cleveland Clinic, Cleveland, Ohio.
authors.forename: Leonard A R
authors.initials: LA
authors.lastname: Golding
authors.affiliation: Department of Biomedical Engineering, Lerner Research Institute, Cleveland Clinic, Cleveland, Ohio. Electronic address: fukamak@ccf.org.
authors.forename: Kiyotaka
authors.initials: K
authors.lastname: Fukamachi
mesh_terms: D000818:Animals; D062186:Arterial Pressure; D016279:Atrial Function, Left; D016280:Atrial Function, Right; D062185:Atrial Pressure; D001672:Biocompatible Materials; D001775:Blood Circulation; D006348:Cardiac Surgical Procedures / Q000295:instrumentation*; D002417:Cattle; D006354:Heart, Artificial; D006439:Hemodynamics; D023421:Models, Animal; D011474:Prosthesis Design; D019919:Prosthesis Implantation / Q000295:instrumentation*; D011673:Pulsatile Flow; D013997:Time Factors
chemical_list: D001672:Biocompatible Materials
keywords: biocompatibility testing; continuous flow; heart-assist; mechanical circulatory support; pumps; total artificial heart