Results of the study, which took place in Europe from October 1999 to December 2002, were presented Sunday, Nov. 9, 2003, at the American Heart Association's 76th Scientific Sessions conference, held in Orlando.
"This study suggests that fully-implantable mechanical heart support is possible and reliable," said John P. Boehmer, M.D., associate professor of cardiology, Penn State Cardiovascular Center, Penn State Milton S. Hershey Medical Center, who presented the results. "Only three device failures were recorded in 17.3 years of support time. We'll continue to improve upon that already-impressive record with device refinements and experience."
The trial of the left ventricular assist device, called the Clinical Utility Baseline Study (CUBS), included 23 male patients from Europe between the ages of 49 and 74 years with end-stage heart failure who were not candidates for heart transplantation. Patients with heart failure have a poor quality of life and low probability of surviving six months. The study was meant to determine the safety and performance of the LionHeart as a permanent method of circulatory support.
In the study, 10 of the 23 patients were released from the hospital. Forty-five percent of patients lived six months with 41 percent living 12 months and 34 percent living 24 months. On average, patients lived about nine months with the device, with one patient living more than three years. Three patients are still living (as of Nov. 1, 2003.) Two blood sacs failed after two years, which is the expected life of the sac, and one motor controller failed. A number of patients had some neurologic dysfunction and bleeding, and five experienced infections.
The LionHear
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Contact: Valerie Gliem
vgliem@psu.edu
814-865-9481
Penn State
12-Nov-2003