Study of VentrAssist heart support device as a bridge to transplantation

May 23 2007

Doctors at UPMC have begun a study using an investigational cardiac device, the VentrAssist, Left Ventricular Assist System (LVAD) to see whether it 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 presents us with a third-generation mechanical solution for end-stage congestive heart failure that approaches the goal of minimal interference with a patient's life. In a subsequent study with this pump, we will focus on support for transplant candidates as well as permanent use for those who do not qualify for heart transplantation, hopefully demonstrating its advantages over previous technology," said Robert Kormos, M.D., co-director of heart transplantation, director of the artificial heart program, medical director of the McGowan Institute for Regenerative Medicine and professor of surgery, division of cardiothoracic surgery at the University of Pittsburgh School of Medicine.

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.

According to the American Heart Association, more than 5 million Americans are diagnosed with heart disease and 550,000 patients are newly diagnosed each year. Despite the significant resources for treatment of this disease, outcomes remain poor. The five-year survival for individuals diagnosed with heart failure is less than 50 percent, and in end-stage heart failure, the one-year survival may be as low as 25 percent regardless of medical therapy.

Currently, there are a limited number of LVADs that are commercially approved for a bridge to heart transplant. Although some patients have benefited from earlier models, many of these devices are large and cumbersome. Patients must be tethered to machines that severely limit their activity. The researchers hope that the VentrAssist LVAD investigational study will help reduce load on the patient's heart while awaiting transplant, improve blood flow and circulation and overall quality of life.

In some cases, the patients with earlier model LVADs demonstrated recovery of their own heart. As a result, they were able to be weaned off the LVAD and avoid heart transplant altogether. It is not known yet whether the VentrAssist LVAD will have the same effect. There is a parallel U.S. clinical trial that will look at the safety and feasibility of the VentrAssist LVAD as an alternative to transplantation.

Dr. Kormos has more than 20 years experience working with artificial heart devices. He is a leading authority in the mechanics of end-stage heart failure and recently chaired a symposium with members of the FDA on adverse reactions to investigational devices at the 27th Annual International Society of Heart and Lung Transplantation meeting.