Under the leadership of McGowan Institute faculty member Robert Kormos, M.D., a trial of a third generation investigational cardiac device, the VentrAssist™ Left Ventricular Assist System (LVAD), is underway at the University of Pittsburgh Medical Center. The trial is designed to see if this new device can be used safely and effectively in patients with end-stage heart failure.
The study hopes to enroll 30 patients overall for the multi-center feasibility trial throughout nine centers in the United States. Five patients at UPMC have received the device so far, and one has successfully received a heart transplant after waiting for nearly three months on the pump, two of which were spent at home on the device.
The VentrAssist™ LVAD is a mechanical blood pump that is implanted in the body to assist the heart to pump blood around the body for people with end-stage heart failure. It is still an experimental investigational device that has been approved by the U.S. Food and Drug Administration only for the purposes of the study.
The blood pump is made of titanium and weighs just over half a pound, compared to the 5 pounds of older pumps. The implanted blood pump is connected to the heart and the aorta by two tubes called cannulae. Blood is drawn directly from the left ventricle and returned to the aorta.
The VentrAssist™ LVAD works in tandem with the natural heart and an external controller regulates the blood pump. Unlike other cardiac assist devices, the VentrAssist™ LVAD has a centrifugal design allowing it to operate in a way that responds to exercise more like the natural heart.
Concurrently, there is a parallel U.S. clinical trial that is looking at the safety and feasibility of the VentrAssist™ LVAD as an alternative to transplantation. Patients using earlier model LVADs demonstrated recovery of their own heart, being weaned off the device and avoiding heart transplant altogether. This other clinical trial will determine if the VentrAssist™ LVAD can be used in this manner as well.
Illustration: VentrAssist™ LVAD. –Ventracor
UPMC News Bureau (05/21/07)
Medical News Today (05/26/07)