DuraHeart LVAS Implant Results Show Improved Survival
April 28, 2008 - Terumo Heart will present data on its DuraHeart LVAS, a circulatory support device intended to provide cardiac support for patients who are at risk of death due to end-stage left ventricular failure, which indicates the device provides safe and reliable long-term circulatory support with improved survival.
Chisato Nojiri, M.D., Ph.D., CEO for Terumo Heart, presented at the ISHLT meeting in Boston results from the report entitled "Long Term Circulatory Support with the DuraHeart Mag-Lev Centrifugal LVAS for Advanced Heart Failure Patients Eligible for Transplantation: European Experience."
The presentation concluded that the DuraHeart LVAS provides safe and reliable long-term circulatory support with improved survival. High device reliability and a low stroke rate despite less intensive anticoagulation offer easier out-of-hospital management.
The presentation summarized results of 55 patients (33 in the CE-mark trial and 22 after market launch) who were implanted with the DuraHeart (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 percent at 6 months and 77 percent at 1 year. Eighteen patients (33 percent) were transplanted at 181 /- 135 days. Thirteen patients (24 percent) were supported > 1 year with the mean support duration of 568 /- 183 days and 2 were supported > 2 years. Twenty-seven patients (49 percent) remain on support for 274 /- 276 (17-1,001) days.
K-M survival at 1 year in the CE-mark trial was 100 percent in patients < 50 years, 94 percent in those < 60 years, 80 percent in those < 65 years, and 67 percent 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 percent 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 support duration. Dr. Nojiri commented, "We are very pleased with the long term results of the device and recently reached a major milestone with a patient reaching 1,000 days of support. This patient will reach 3 years on the device on July 4th 2008."
The DuraHeart LVAS is not available for sale in the U.S., but Terumo Heart has received conditional approval from the FDA to commence a multicenter pivotal trial in the United States and plans to conduct the first implants at its principal investigational sites in the near future.
For more information: www.terumo.com
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