Smaller, simpler device can be used in more patients, expert says
WEDNESDAY, Aug. 29 (HealthDay News) -- A new kind of heart pump helped patients with heart failure so severe that their only option was a transplant, cardiologists report.
"The design is completely different from existing assist devices," said Dr. Leslie W. Miller, chief of cardiology at Washington Hospital Center, referring to the Heart Mate II that was implanted in 133 people with end-stage heart failure. "They are pulsatile, stimulating the function of the left ventricle, which injects blood into the bloodstream. This is a continuous flow device."
At six months, 75 percent of those with device were still alive, with a 12-month survival rate of 68 percent.
"The results were very positive," said Miller, lead author of a report on the trial in the Aug. 30 issue of the New England Journal of Medicine. "These patients were so sick that it was hard to get more than 75 percent survival at six months."
The device performed well mechanically, Miller said. And there was no increased incidence of blood clotting or similar problems when compared to older generations of such devices.
Data from the trial is being submitted to the U.S. Food and Drug Administration by Thoratec, the California company that plans to market the device and funded the trial. An FDA expert panel will consider whether the agency will approve the device as a bridge to heart transplants.
Another study of the device as a permanent implant for people with less severe heart failure has just been completed, and that data will also be submitted to the FDA, Miller said.
The device "looks like a flashlight," he said. "It weighs about 14 grams, and is about a fifth the size of existing devices. It is also silent in operation."
That small size "will open the door for use in more patients," said Dr. Kenneth L. Baughman, a professor of medicin
All rights reserved