title: Pre-clinical evaluation of the infant Jarvik 2000 heart in a neonate piglet model.
abstract: BACKGROUND
  The infant Jarvik 2000 heart is a very small, hermetically sealed, intracorporeal, axial-flow ventricular assist device (VAD) designed for circulatory support in neonates and infants. The anatomic fit, short-term biocompatibility and hemodynamic performance of the device were evaluated in a neonate piglet model.
  
  
  METHODS
  The infant Jarvik 2000 heart with two different blade profiles (low- or high-flow blade design) was tested in 6 piglets (8.8 ± 0.9 kg). Using a median sternotomy, the pump was placed in the left ventricle through the apex without cardiopulmonary bypass. An outflow graft was anastomosed to the ascending aorta. Hemodynamics and biocompatibility were studied for 6 hours.
  
  
  RESULTS
  All 6 pumps were implanted without complication. Optimal anatomic positioning was found with the pump body inserted 2.4 cm into the left ventricle. Hemodynamics demonstrated stability throughout the 6-hour duration. The pump flow increased from 0.27 to 0.95 liter/min at increasing speeds from 18 to 31 krpm for the low-flow blade design, whereas the pump flow increased from 0.54 liter/min to 1.12 liters/min at increasing speeds from 16 krpm to 31 krpm for the high-flow blade design. At higher speeds, >80% of flow could be supplied by the device. Blood chemistry and final pathology demonstrated no acute organ injury or thrombosis for either blade design.
  
  
  CONCLUSIONS
  The infant Jarvik 2000 heart is anatomically and biologically compatible with an short-term neonate piglet model. This in vivo study demonstrates the future feasibility of this device for clinical use.
authors.affiliation: Department of Surgery, University of Maryland School of Medicine, Baltimore, Maryland 21201, USA.
authors.forename: Xufeng
authors.initials: X
authors.lastname: Wei
authors.forename: Tieluo
authors.initials: T
authors.lastname: Li
authors.forename: Shuying
authors.initials: S
authors.lastname: Li
authors.forename: Ho Sung
authors.initials: HS
authors.lastname: Son
authors.forename: Pablo G
authors.initials: PG
authors.lastname: Sanchez
authors.forename: Pablo
authors.initials: P
authors.lastname: Sanchez
authors.forename: Shuqiong
authors.initials: S
authors.lastname: Niu
authors.forename: A Claire
authors.initials: AC
authors.lastname: Watkins
authors.forename: Christopher
authors.initials: C
authors.lastname: DeFilippi
authors.forename: Robert
authors.initials: R
authors.lastname: Jarvik
authors.forename: Zhongjun J
authors.initials: ZJ
authors.lastname: Wu
authors.forename: Bartley P
authors.initials: BP
authors.lastname: Griffith
mesh_terms: D000818:Animals; D000831:Animals, Newborn; D006353:Heart-Assist Devices; D023421:Models, Animal; D011474:Prosthesis Design; D013552:Swine