University of Maryland Surgeons are First in U.S. to Implant Heart Pump in Comparative Study of Two Devices

For immediate release: September 09, 2004

Contact:

Bill Seiler

bseiler@umm.edu | 410-328-8919

First-of-its-kind study evaluates two heart pumps for patients ineligible for transplant

Cardiac surgeons at the University of Maryland Medical Center have implanted a heart pump in a 51-year-old man with advanced heart failure, marking the start of the first multi-center study to compare two different heart pumps as “destination therapy” for patients who are not eligible for a heart transplant. The first patient, Victor Batts from Randallstown, Md., went home from the medical center with his new pump on September 9.

Heart pumps were initially approved as a “bridge to transplant,” to assist a person's ailing heart until a donor heart could be found for transplantation. Two years ago, the Food and Drug Administration (FDA) approved a device from Thoratec Corporation, called HeartMate, for use either as a bridge to transplant or as destination therapy, which is a permanent treatment for severely ill heart failure patients who are not candidates for a heart transplant.

This new 40-center study will compare the HeartMate with a different pump made by World Heart Corporation, the Novacor Left Ventricular Assist System (LVAS), for use as destination therapy. The study, called the RELIANT trial (Randomized Evaluation of the Novacor LVAS In A Non-Transplant Population), is sponsored by World Heart, which seeks FDA approval for its device as destination therapy in addition to use as a bridge to transplant.

“Heart failure patients who are not eligible for a transplant typically have a history of medical problems, such as cancer or diabetes, that could become worse with the anti-rejection medicine required to prevent the body's immune system from attacking the new heart,” says Richard N. Pierson III, M.D., clinical director of heart and lung transplantation at the University of Maryland Medical Center and an associate professor of surgery at the University of Maryland School of Medicine.

“Participation in the RELIANT study will give these patients, in whom all medical choices have been exhausted, unique access to cutting edge technology and long term follow-up that may improve their quality of life,” says Dr. Pierson, who led the team that implanted the first pump as part of the RELIANT study on July 30, 2004.

Nearly 5 million people in the U.S. suffer from heart failure and about 550,000 people are diagnosed with it each year. It can be caused by high blood pressure, abnormal heart valves and heart muscle disease. Smoking, being overweight, a high fat diet and lack of exercise all increase the risk.

“Heart failure is a condition in which the heart's muscle becomes weakened and gradually loses its ability to supply enough blood to meet the body's needs. It usually causes shortness of breath and fluid retention,” according to Stephen S. Gottlieb, M.D., director of heart failure and cardiac transplantation at the University of Maryland Medical Center and professor of medicine at the University of Maryland School of Medicine.

Only 2,057 heart transplants were performed in the U.S. in 2003, while about 3,500 people are currently waiting for heart transplants, evidence that the need is greater than the number of available hearts. Advanced heart failure patients who are ineligible for a transplant need mechanical assistance to stay alive. Left ventricular assist devices that boost the heart's own pumping function have been developed to address that need.

“The field of heart pump development is not static. New ideas and new equipment continue to present a variety of opportunities to impact heart failure,” says Bartley P. Griffith, M.D., chief of Cardiac Surgery at the University of Maryland Medical Center and professor of surgery and head of the Division of Cardiac Surgery at the University of Maryland School of Medicine. He adds, “We are pleased to be in the forefront of this national study and hope that it will benefit our patients in a major way.”

A total of 390 patients will be recruited for the RELIANT study. Those selected must have advanced heart failure, be short of breath even while resting, and be unable to perform normal daily activities. After recovering from their surgery, patients will return home with their lifesaving pump. The pump is connected by a wire through the skin to an external battery pack that patients will carry with them in a small bag or backpack. Each pump's mechanical function will be monitored and tested over time. The study will also assess the patient's physical well-being and quality of life.

In addition to the HeartMate and the Novacor LVAS, cardiac surgeons at the University of Maryland Medical Center also have experience with a third heart pump, the Jarvik 2000, which has been approved only as a bridge to transplant. The first two patients in the U.S. who were able to go home with a Jarvik 2000 heart pump to await a transplant had their implantation at the University of Maryland Medical Center.

The Jarvik 2000 is a small, turbine pump, which produces continuous blood flow and is implanted inside the left ventricle, the heart's main pumping chamber. The Novacor LVAS and the HeartMate LVAS both produce a pulse similar to a normal heartbeat. They are larger devices than the Jarvik, are implanted in the abdomen, and are connected to the heart with tubes.

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