title: Mechanical reliability of the Jarvik 2000 Heart.
abstract: BACKGROUND
  Device failure is a limitation of permanent mechanical circulatory support. We studied the mechanical reliability of the Jarvik 2000 Heart, an axial flow pump with ceramic bearings designed to provide more than 10 years' durability.
  
  
  METHODS
  The Jarvik 2000 Heart was implanted in 102 patients between April 2000 and December 2004. Eighty-three pumps with an abdominal driveline were implanted as a bridge-to-transplantation, and 19 with postauricular power supply as lifetime therapy. Eighteen pumps were recovered intact after clinical use and run continuously on the bench to further assess durability.
  
  
  RESULTS
  No implantable component failure occurred either in patients or during bench testing. The cumulative pump run-time was 110 years: 59 years overall in vivo and 51 years in vitro. The mean support time for bridge-to-transplant recipients was 159 days, and for discharged lifetime-therapy recipients 551 days. Six recipients were supported moer than 2 years, with the longest ongoing approaching 5 years. External cables caused three system failures, with a 95% freedom from system failure at 4 years. Device malfunctions, related to external cables (9) and lack of a backup battery (1), caused no adverse consequences. Before introduction of noncorrosive, gold-plated stainless steel connectors, corrosion was observed on three connectors to the retroauricular power supply.
  
  
  CONCLUSIONS
  The Jarvik 2000 Heart has had no implantable component failure. Meaningful durability data and failure mode can only be established by real-time testing in patients. The reliability and dependability of this device, in addition to the exchangeability of external components, give promise for long-term circulatory support in critically ill heart failure patients.
authors.affiliation: Center for Cardiovascular Disease, University of Freiburg, Freiburg, Germany. siegenth@ch11.ukl.uni-freiburg.de
authors.forename: Michael P
authors.initials: MP
authors.lastname: Siegenthaler
authors.forename: O H
authors.initials: OH
authors.lastname: Frazier
authors.forename: Friedhelm
authors.initials: F
authors.lastname: Beyersdorf
authors.forename: Jürgen
authors.initials: J
authors.lastname: Martin
authors.forename: Hillel
authors.initials: H
authors.lastname: Laks
authors.forename: John
authors.initials: J
authors.lastname: Elefteriades
authors.forename: Asghar
authors.initials: A
authors.lastname: Khaghani
authors.forename: Ulf
authors.initials: U
authors.lastname: Kjellman
authors.forename: Bansi
authors.initials: B
authors.lastname: Koul
authors.forename: John
authors.initials: J
authors.lastname: Pepper
authors.forename: Robert
authors.initials: R
authors.lastname: Jarvik
authors.forename: Stephen
authors.initials: S
authors.lastname: Westaby
mesh_terms: D019544:Equipment Failure Analysis; D006353:Heart-Assist Devices; D012189:Retrospective Studies