European experience of DuraHeart magnetically levitated centrifugal left ventricular assist system.
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.
Morshuis
Michiel
M
Heart & Diabetes Center, North Rhine-Westphalia, Bad Oeynhausen, Germany.
El-Banayosy
Aly
A
Arusoglu
Latif
L
Koerfer
Reiner
R
Hetzer
Roland
R
Wieselthaler
Georg
G
Pavie
Alain
A
Nojiri
Chisato
C
D000328:Adult; D000368:Aged; D000925:Anticoagulants / Q000627:therapeutic use; D004867:Equipment Design; D005260:Female; D006333:Heart Failure / Q000628:therapy*; D016027:Heart Transplantation; D006353:Heart-Assist Devices / Q000009:adverse effects; D006801:Humans; D008280:Magnetics; D008297:Male; D008875:Middle Aged; D019990:Perioperative Care / Q000379:methods; D011446:Prospective Studies; D016019:Survival Analysis; D016896:Treatment Outcome
D000925:Anticoagulants