Updated Results On Heart Assist Device Presented At International Transplant Meeting

April 23, 1999

Includes Data Submitted For FDA Approval Of Novacor® System

SAN FRANCISCO, April 23 -- Results of a study of more than 150 patients sustained on the Novacor® Left Ventricular Assist System (LVAS) as a "bridge" to transplantation were presented for the first time at the International Society for Heart and Lung Transplantation (ISHLT) annual meeting today. The findings, which represent experiences of 22 U.S. transplant centers, included data that served as the basis for U.S. Food and Drug Administration (FDA) approval of the system less than a year ago. The Novacor LVAS is a product of the Cardiovascular Group of Baxter Healthcare Corporation.

Those patients who were discharged from the hospital with the Novacor LVAS while waiting for donor hearts fared better than patients whose medical condition required them to stay in the hospital, reported Robert Kormos, M.D., associate professor of surgery and director of the artificial heart and adult transplantation program at the University of Pittsburgh Medical Center (UPMC). About a third of the patients (29 percent) waited outside the hospital, six for more than a year and two for more than two years, allowing them the opportunity to lead normal, productive lives.

"The clinical experience with the discharged patients indicates there is improved quality of life and highlights the safety and feasibility for long-term use," said Dr. Kormos, a principal investigator of the multi-center trial.

With the number of patients being placed on transplant waiting lists growing each year but the supply of available organs remaining relatively stagnant, artificial assist devices serve a critical function by providing patients a means to sustain heart function until human donor hearts can be found. There are currently more than 4,200 patients on the national heart transplant waiting list, according to the United Network for Organ Sharing, and waiting times can exceed two or three years in some parts of the country. About 20 percent of those waiting die each year; last year, more than 760 died waiting for hearts.

"Assist devices have literally saved patients' lives who could have easily been counted as another death statistic. And unless we are able to produce enough organs to meet the supply, we will need to depend more and more on this type of technology," commented Dr. Kormos, who is also president-elect of the ISHLT.

The FDA approved the Novacor LVAS in September 1998, but the results presented by Dr. Kormos today had not previously been presented or published.

Between 1996 and 1998, 156 patients were placed on the Novacor LVAS, an electromagnetically driven pump surgically implanted in the abdomen that connects to the heart's main pumping chamber, the left ventricle. An electronic controller and battery pack worn on a belt or as a shoulder bag provide power. Their outcomes were compared to a group of 35 control patients who were treated with conventional medical therapy.

Of the 156 patients, 129 met all study entry criteria. Of the LVAS patients, 77 percent were successfully transplanted, compared to 37 percent of the control group. Deaths on the waiting list were fewer for those on the Novacor LVAS, 23 percent compared to 63 percent for those patients not placed on an assist system, reported Dr. Kormos.

Fourteen patients in the study remain on the device still waiting for heart transplantation. The average time on the device was 97 days; one patient has remained on the device now for nearly 1,000 days.

The Novacor LVAS provides circulatory support by taking over most of the workload of the failing heart. An inflow circuit directs blood from the left ventricle into the blood pump, and the pump ejects blood through an outflow conduit into the body's arterial system.

The wearable controller and batteries are connected to the implanted pump by a small tube containing several wires through the patient's skin. The system is self-regulating, responding instantaneously to a patient's changing heartbeat and circulatory demands.

UPMC has gained some of the most extensive experience using the Novacor LVAS as well as other assist systems. In addition to its active clinical program, UPMC also performs basic and animal research of various devices at its McGowan Center for Artificial Organ Development.

University of Pittsburgh Medical Center

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