Study Data Show Positive European Experience With DuraHeart Left Ventricular Assist Device for Advanced Stage Heart Failur...(support duration for this study populati...),Health

Date:4/7/2009

support duration for this study population was 242 days plus or minus 243 days (range: 19 - 1148, median: 161) with a cumulative duration of 45 years. As of the publication date, 35 patients (51 percent) remained in ongoing treatment with DuraHeart, 18 patients were transplanted, one device was explanted and 14 patients died during support with a median time to death of 62 days. The Kaplan-Meier survival rate during support for the 68 patients in the clinical trial and post-trial period was 81 percent at six months and 77 percent at one year.

Of the 13 patients (21 percent) supported for >1 year, four supported for > two years, one supported > three years, two transplanted, two died, and nine ongoing with a mean duration of 744 plus or minus 216 days (range: 537 ¿ 1,148, median: 651). There were no reports of device thrombosis, hemolysis, peripheral thromboembolic events, myocardial infarction or chronic renal dysfunction.

The total major adverse event rates during DuraHeart support were acceptable in comparison to first generation pulsatile and second generation axial flow LVADs. The event rate of bleeding requiring surgery (0.22 per patient-year) was considerably lower for the third-generation DuraHeart when compared with the rate for first- and second-generation LVADs (1.47 and 0.78, respectively). Additionally, driveline or pocket infection rate was reduced by 90 percent as compared to the pulsatile device (0.40 vs. 3.49) and comparable to the small axial flow devices (0.40 and 0.37).

The rate of neurological events for 33 trial patients was 50 percent less than that of pulsatile devices (0.56 vs. 1.11) and slightly higher than the rate in the axial flow device group (0.56 vs. 0.45). The most significant number of adverse events, including fatal intra-cerebral bleeding (75 percent) and other bleeding complications was observed in the first 11 patients. The investigators recognized that the risk
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SOURCE Terumo Heart, Inc. Copyright©2009 PR Newswire. All rights reserved

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