"Despite the shortcomings of the device, the results of this trial speak to our ability to improve the functionality for a very sick group of patients," Rogers said. The major complications of LVADs, said the researchers, include stroke, bleeding episodes and infections, especially at the site in the side of the body where the pump is connected to an external power source and computer.
"We already had a lot of data on the device when it was being used as bridge to transplantation," he continued. "We knew it could go for extended periods without problems, and that was the most compelling argument to use for implanting the device in patients who have no other options."
For the trial, researchers enrolled 55 patients from 2000 to 2003. Thirty-seven patients received the device and 18 did not. Patients were on average of 59 years old and as a group their hearts beat at only 14 percent of normal strength. The pump tested in the trial was the Novacor device, which is produced by WorldHeart, Oakland, Calif.
"While the survival time for those patients receiving LVADs was more than three times longer, we even had two patients who are both four years out from implantation," said Rogers. "Furthermore, unlike some earlier studies, there were no catastrophic mechanical failures."
According to Rogers, there are a number of challenges to be addressed before the use of LVADs can be considered as a widespread destination therapy.
The first challenge is selecting appropriate patients, which is crucial, since the patients most likely to survive would be those who are quite sick, but not too sick to be beyond help. This fine line in determining which patients are optimal will need to be defined by future clinical trials,
Source:Duke University Medical Center