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North Idaho man gets new heart pump in national trial

Thu., Oct. 28, 2004

The search for a more durable heart pump to help the sickest heart patients is under way in Spokane. A 60-year-old North Idaho man on Tuesday received a Novacor heart pump at Sacred Heart Medical Center.

The man is the second patient in a national clinical trial that will compare survival rates for two brands of heart pump: the Novacor pump and the HeartMate pump, now the only pump approved for permanent use by the U.S. Food and Drug Administration.

The patient did not want to be identified.

Dr. Timothy Icenogle, who performed the successful five-hour surgery, has been involved with mechanical heart research since 1985.

“The changes have been dramatic over the course of my career,” Icenogle said Wednesday. “We’ve seen these devices go from being completely investigational, to approved for use as a bridge to transplant and now to destination therapy. We’ve seen complication rates drop precipitously as we’ve developed a team approach to the care of these kinds of patients.”

For patients, Icenogle said, “the quality of life is far greater. We expect everybody to go home.”

The devices do fail. A study published in August in the Journal of Heart and Lung Transplantation found device failure after two years in 64 percent of 102 devices implanted at one British institution. The device studied was the HeartMate pump.

“It’s about a two-year pump,” Icenogle said. “We need a pump that goes five to 10 years. Novacor is generally felt by those of us who do these end-stage cases to be more durable.”

But the Novacor pump has a higher rate of strokes in patients than the HeartMate pump, Icenogle said. Patients receiving a Novacor pump require anticoagulation medication. So far, the FDA has approved the Novacor only as a way to keep patients alive while waiting for a heart transplant.

The Novacor pump is a left ventricular assist device, or LVAD. Placed in the patient’s abdomen, it moves blood from the weakened part of the heart to the aorta, the body’s main blood artery.

Patients wear an external battery pack that runs the pump.

With 2,100 hearts transplanted each year and an estimated 3,500 people on the waiting list, there is a need for an alternative. Transplant centers set various criteria patients must meet to be eligible for a transplant.

Patients who are both very sick and do not meet transplant criteria are eligible for the pump study.

Icenogle expects another five to 10 patients to participate. In addition, he expects two competing studies to be available here within the next six months.

Novacor is made by World Heart Inc. of Oakland, Calif.


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