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Mechanical reliability of the Jarvik 2000 Heart - Discussion

Siegenthaler, MP; Frazier, OH; Beyersdorf, F; Martin, J; Laks, H; Elefteriades, J; Khaghani, A; Kjellman, U; Koul, Bansi LU and Pepper, J, et al. (2006) In Annals of Thoracic Surgery 81(5). p.1752-1759
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 post-auricular 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... (More)
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 post-auricular 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. (Less)
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Annals of Thoracic Surgery
volume
81
issue
5
pages
1752 - 1759
publisher
Elsevier
external identifiers
  • wos:000237001700030
  • pmid:16631667
  • scopus:33646839431
ISSN
1552-6259
DOI
10.1016/j.athoracsur.2005.12.013
language
English
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yes
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9474b947-ff7a-4564-aebe-83341fab7868 (old id 411291)
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http://ats.ctsnetjournals.org/cgi/content/abstract/81/5/1752
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2007-10-19 10:03:50
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2019-03-17 03:43:04
@article{9474b947-ff7a-4564-aebe-83341fab7868,
  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 post-auricular 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.},
  author       = {Siegenthaler, MP and Frazier, OH and Beyersdorf, F and Martin, J and Laks, H and Elefteriades, J and Khaghani, A and Kjellman, U and Koul, Bansi and Pepper, J and Jarvik, R and Westaby, S and Kurlansky, P and Kormos, RL and Bolman, M},
  issn         = {1552-6259},
  language     = {eng},
  number       = {5},
  pages        = {1752--1759},
  publisher    = {Elsevier},
  series       = {Annals of Thoracic Surgery},
  title        = {Mechanical reliability of the Jarvik 2000 Heart - Discussion},
  url          = {http://dx.doi.org/10.1016/j.athoracsur.2005.12.013},
  volume       = {81},
  year         = {2006},
}