eart failure can make even walking around the house too strenuous. Unlike a heart attack, in which heart muscle dies from lack of blood, patients with heart failure have hearts that are chronically too weak to pump the blood their bodies need. The 400,000 Americans who are diagnosed with this condition annually can only wait for the remote chance that one of the 2,300 donor hearts will be a match for transplant. They know an artificial heart is still years from being as common as an artificial hip.

As an alternative to a complete artificial heart, Penn State researchers have developed a pump to assist — rather than replace -a weak heart. In February 2001, the Food and Drug Administration approved this pump for clinical trials. The device is a left ventricular assist system called the Arrow LionHeart™ LVAS. Phase I clinical trials are limited to seven patients before researchers receive approval to expand to Phase II.

Researchers at Penn State spent more than 30 years trying to develop an artificial heart. For the past eight years, the Artificial Organs Program, an interdisciplinary team of doctors, scientists, and engineers, has worked with Arrow International, Inc., of Reading, Pennsylvania, a company that manufacturers cardiac care products.

Unlike an artificial heart, the LionHeart takes over the pumping for the heart's left ventricle only. One of four chambers of the heart, the left ventricle is responsible for pumping blood to the entire body and is under the most stress.

The LionHeart is completely internal. The implanted components, placed below the patient's heart, weigh 3.2 pounds. (Comparatively, the average human heart weighs just over 10.5 ounces, or about two-thirds of a pound.) Currently, there is no LionHeart model for women because their chest cavities are on average smaller than men's and can't accommodate the device.

"Currently all assist pumps have drive lines or external tethers that protrude through the skin. These lines often cause infections," said Gerson Rosenberg, professor of surgery and chief of the Division of Artificial Organs. "The LionHeart ventricular assist system and the Penn State replacement heart are both totally implantable. These devices, which address different patients, will greatly reduce the chance for infection, improve mobility for patients, and enhance their quality of life." The Penn State replacement heart is an internal artificial heart, but it is not yet in clinical trials.

In the LionHeart's clinical trials, surgeons place the components inside the patient's chest and abdomen. The LionHeart's blood pump contains a plastic blood sack that fills with the patient's blood after each "beat." Then, the pump's metal plate presses against the sack, forcing the blood out of it and into the body. An electric motor powers the LionHeart and an automatic control algorithm increases circulation when a patient is exercising and decreases it when he is resting.

The patient carries an eight-pound external battery pack either on a shoulder harness, in a backpack, or in a handcart. A belt connects from the battery pack to an external transformer coil that transmits electrical current through the skin to an internal transformer coil on the left side, slightly below the chest. A patient has no wires or tubes protruding from his chest. The internal batteries have enough power that the patient can take off the external pack for 20 minutes — to take a shower, for example — before the device begins beeping to let the patient know it is running out of power.

The LionHeart is intended as a "destination," the primary long-term therapy for those with end-stage heart failure who are ineligible for heart transplant because of age or other significant health problems. The LionHeart currently is the only option for these patients.

"Arrow LionHeart recipients have a better quality of life and are more mobile because of this system," said Walter Pae, Jr., professor of surgery at Penn State College of Medicine and director of transplantation at Penn State Milton S. Hershey Medical Center. "I expect this will help thousands of people around the world," he said.

The first U.S. patient to receive the pump, Edmond Dzurishin, 65, of Hazleton, Pennsylvania, lived with the LionHeart for nearly five months. He died July 24, having not recovered from a gastrointestinal bleed he developed in the weeks following the surgery. The pump's mechanics did not fail.

Ten patients in Europe have received the pump since October 1999. A 68-year-old German has lived with the heart assist pump for over a year and currently resides at home.

Gerson Rosenberg, Ph.D., is professor of surgery and chief of the Division of Artificial Organs. He is also the Jane A. Fetter Professor of Surgery at the Penn State College of Medicine, professor of surgery and bioengineering, College of Medicine and College of Engineering and chief, Division of Artificial Organs, Department of Surgery. He directs the Penn State Institute for Biomedical Engineering and is the principal investigator of the electric total artificial heart project at the Penn State Milton S. Hershey Medical Center, 500 University Dr., Box 850, Hershey, PA 17033-0850; 717 531 6301; grosenberg@psu.edu.

Walter Pae, Jr., M.D., is professor of surgery in the section of Cardiothoracic Surgery at Penn State College of Medicine and director of transplantation at Penn State Milton S. Hershey Medical Center, 500 University Dr., Box 850, Hershey, PA 17033-0850; 717-531-8329; wpae@psu.edu.

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