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Michael P. Siegenthaler
Friedhelm Beyersdorf
Hillel Laks
John Elefteriades
Asghar Khaghani
Ulf Kjellman
John Pepper
Stephen Westaby
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Right arrow Mechanical Circulatory Assistance

Ann Thorac Surg 2006;81:1752-1759
© 2006 The Society of Thoracic Surgeons

Original article: Cardiovascular

Mechanical Reliability of the Jarvik 2000 Heart

Michael P. Siegenthaler, MD a , * , O.H. Frazier, MD b , Friedhelm Beyersdorf, MD a , Jürgen Martin, MD a , Hillel Laks, MD c , John Elefteriades, MD d , Asghar Khaghani, MD e , Ulf Kjellman, MD f , Bansi Koul, MD g , John Pepper, MD h , Robert Jarvik, MD i , Stephen Westaby, MD j

a Center for Cardiovascular Disease, University of Freiburg, Freiburg, Germany
b Department of Cardiovascular Surgery, Texas Heart Institute, Houston, Texas
c Department of Cardiothoracic Surgery, University of California at Los Angeles, Los Angeles, California
d Cardiothoracic Surgery, Yale New Haven Hospital, New Haven, Connecticut
e Cardiothoracic Surgery, Royal Brompton and Harefield Hospitals, London, United Kingdom
f Department of Cardiovascular Surgery, Sahlgrenska University Hospital, Goteborg, Sweden
g Department of Cardiovascular Surgery, University Hospital Lund, Lund, Sweden
h Department of Cardiovascular Surgery, Royal Brompton and Harefield Hospital Trust and Imperial College, London, United Kingdom
i Jarvik Heart, Inc, New York, New York
j Department of Cardiovascular Surgery, John Radcliffe Hospital, Oxford, United Kingdom

Accepted for publication December 2, 2005.

* Address correspondence to Dr Siegenthaler, Center for Cardiovascular Disease, University of Freiburg Medical Center, Hugstetterstrasse 55, Freiburg 79106, Germany (Email: siegenth{at}ch11.ukl.uni-freiburg.de).

Presented at the Forty-first Annual Meeting of The Society of Thoracic Surgeons, Tampa, FL, Jan 24–26, 2005.

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.




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