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ANN ARBOR, Mich., April 28 /PRNewswire/ -- Terumo Heart, Inc. announced a presentation at the recent ISHLT meeting in Boston. The presentation entitled "Long Term Circulatory Support with the DuraHeart(TM) Mag-Lev Centrifugal LVAS for Advanced Heart Failure Patients Eligible for Transplantation: European Experience" was delivered by Chisato Nojiri, M.D., Ph.D., Chief Executive Officer for Terumo Heart, Inc.
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The presentation summarized results of 55 patients (33 in the CE-mark trial and 22 after market launch) who were implanted with the DuraHeart(TM) (LVAS) Left Ventricular Assist System between January 2004 and March 2008. The average duration of support was 214 +/- 226 days with a cumulative duration of 32 years. The Kaplan-Meier (K-M) survival was 82% at 6 months and 77% at 1 year. Eighteen patients (33%) were transplanted at 181 +/- 135 days. Thirteen patients (24%) were supported > 1 year with the mean support duration of 568 +/- 183 days and 2 were supported > 2 years. Twenty-seven patients (49%) remain on support for 274 +/- 276 (17-1,001) days.
K-M survival at 1 year in the CE-mark trial was 100% in patients < 50
years, 94% in those < 60 years, 80% in those < 65 years, and 67% in those
greater than or equal to 65 years. Stroke free survival at 1 and 2 years in
the CE-mark trial (33 patients) was 94% for the last 22 patients after
implementing a less intensive anticoagulation/anti-platelet regimen. There
was no pump mechanical failure, pump thrombosis, or hemolysis throughout
the supp
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