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European experience of DuraHeart^TM magnetically levitated centrifugal left ventricular assist system

^a Heart & Diabetes Center, North Rhine-Westphalia, Bad Oeynhausen, Germany
^b German Heart Institute, Berlin, Germany
^c University of Vienna, Vienna, Austria
^d Pitie Salpetriere Hospital, Paris, France
^e Terumo Heart, Inc., Ann Arbor, MI, USA

Received 1 September 2008; received in revised form 14 December 2008; accepted 16 December 2008.

^_* Corresponding author. Tel.: +1 734 7416114; fax: +1 734 7416270. (Email: chisato.nojiri{at}terumomedical.com).

Objective: The DuraHeart (Terumo Heart, Inc., Ann Arbor, Michigan, USA) is the world's first approved magnetically levitated centrifugal left ventricular assist system designed for long-term circulatory support. We report the clinical outcomes of 68 patients implanted with the DuraHeart as a bridge to cardiac transplantation in Europe. Methods: Sixty-eight patients with advanced heart failure (six females), who were eligible for cardiac transplantation were implanted with the DuraHeart between January 2004 and July 2008. Median age was 58 (range: 29–74) years with 31% over 65 years. Thirty-three of these patients received the device as a part of the European multi-center clinical trial. Survival analyses were conducted for 68 patients and other safety and performance data were analyzed based on 33 trial patients. Results: Mean support duration was 242 ± 243 days (range: 19–1148, median: 161) with a cumulative duration of 45 years. Thirty-five patients (51%) remain ongoing, 18 transplanted, 1 explanted, and 14 died during support with a median time to death of 62 days. The Kaplan–Meier survival rate during support was 81% at 6 months and 77% at 1 year. Of the 13 patients (21%) supported for >1 year, 4 supported for >2 years, 1 supported >3 years, 2 transplanted, 2 died, and 9 ongoing with a mean duration of 744 ± 216 days (range: 537–1148, median: 651). Major adverse events included driveline/pocket infection, stroke, bleeding, and right heart failure. There was no incidence of pump mechanical failure, pump thrombosis, or hemolysis. Conclusions: The DuraHeart was able to provide safe and reliable long-term circulatory support with an improved survival and an acceptable adverse event rate in advanced heart failure patients who were eligible for transplantation.

Key Words: Left ventricular assist device • Bridge to cardiac transplantation • Rotary blood pump • Magnetic levitation