ARLINGTON, Va., May 17, 2002 – A new study shows that an implantable heart pump could provide permanent assistance to heart failure patients while substantially improving their quality of life.

The study, appearing in the journal Circulation, is one of the longest follow-up studies on an implantable left ventricle assist device (LVAD), and it adds to the growing body of evidence supporting LVADs as permanent implants.

Although LVADs have been in development for decades, they have been targeted primarily as a bridge to a heart transplant and not meant as a permanent therapy for congestive heart failure.

In the study, a team of British and American researchers followed four British patients for up to 20 months after they received an LVAD called the Jarvik 2000.

The Jarvik 2000 consists of a continuous rotary pump about the size of a “C” battery implanted inside the heart’s left ventricle, the heart’s main pumping chamber. A synthetic tube allows the pump to deliver oxygen-rich blood via the aorta throughout the body. Power comes from rechargeable batteries, worn at the waist or carried in a small shoulder bag, and connects to an implanted cable through a small port just behind the ear.

All the patients were considered ineligible for heart transplants due to their age and poor kidney function, and all were in class IV heart failure, in which the heart can’t pump enough blood to meet the body’s needs. Such patients experience severe shortness of breath and frequent chest pain. They quickly tire and have great difficulty performing simple activities.

Three of the patients went home three to eight weeks after receiving the pump and returned to normal activities. There were no infections or blood clots reported in or near the device. One of the four British patients who was too sick to walk across the surgeon’s office before getting the heart-assist device nearly two years ago now routinely walks 5 miles a day and has completed a long-distance charity walk.

After receiving the pump, three patients could perform moderate to heavy exertion before experiencing chest pain or breathlessness. One patient developed a brain hemorrhage under the electrical port, which is mounted in the skull. Although the hemorrhage was successfully treated, he suffered right heart failure and died about three months later. Surgeons subsequently modified their technique to prevent such complications.

The fluid retention caused by a failing heart disappeared in all three patients, the researchers wrote. In fact, after three months, patients were able to stop taking diuretics, the drugs commonly given to heart-failure patients to help rid the body of excess fluid. Also during the first three months, echocardiography showed improvement in the patients' left and right ventricle function.

"This small, simple, safe pump can be implanted with little or no time on a heart-lung machine. It poses very little risk and can boost the patient's native heart function," says author O.H. "Bud" Frazier, M.D., chief of cardiopulmonary transplantation and director of surgical research at the Texas Heart Institute in Houston.

The current study indicates that a patient's own heart function improves after time on the pump. "In most of these patients, all their hearts need is a boost," Frazier says. "That's what the pump does. With the Jarvik 2000 taking over part of the work, the heart thinks it's normal again. There has to be a synergy. It is not designed to totally take over or replace left ventricular function."

The American Heart Association estimates that between 60,000 to 70,000 of the nation’s 4.8 million congestive heart failure patients are class IV, but only about 2,000 hearts are available for transplant each year. The researchers estimate that half of all class IV patients, or some 30,000 patients, could benefit from the Jarvik 2000 and other left ventricular assist devices, such as the Arrow LionHeart™ and the HeartMate® . The U.S. Food and Drug Administration has approved all three devices only as a bridge to transplant.