Wednesday, October 01, 2008

Miniature Cardiac Pump Saves Lives as Children Wait for Hearts

By Michelle Fay Cortez Bloomberg

Miniature pumps that take over for a damaged heart can keep the smallest children alive as they wait, sometimes for months, until a donated organ is available, a study found.

Researchers tracked the fate of nine children ranging from a 12-day-old infant to a 17-year-old youth who received the tiny device made by Berlin Heart GmbH under a special program for those with no other options. While machines from Thoratec Corp., World Heart Corp., Ventracor Ltd. and HeartWare Ltd. are available or under development for adults and older children, the smallest patients in the U.S. have few treatment options.

The study in the journal Circulation found eight of the nine children survived, with the youngest dying from kidney damage that worsened after surgery to install the device. All the others treated at Saint Louis Children's Hospital in Missouri received transplants after as many as 77 days using the device, known as the Excor, and are doing well. The pumps kept the children strong until they underwent surgery for a heart transplant.

``These kids are going into the operating room in very good physical shape,'' said lead author Sanjiv Gandhi, surgical director of the heart failure program at Washington University School of Medicine in Saint Louis, in a telephone interview. ``It's a huge difference compared to a patient in the intensive care unit on a bunch of machines, immobilized.''

Waiting List

More than 250 children age 17 and under are waiting for heart transplants in the U.S., according to the Organ Procurement and Transplantation Network.

Larger heart pumps are approved for U.S. use in adults and children aged 5 and older. Children who don't qualify for the device typically undergo a treatment where the blood is removed from the body, oxygenated, then slowly returned. The approach isn't effective for long-term use, carries side effects that can include infections and neurological impairment, and requires the child to be immobilized, the researchers said.

The small heart pumps cost about $50,000 and have been available in Europe for several years, Gandhi said. Germany's Berlin Heart started a study in December 2007 that may help win U.S. Food and Drug Administration approval of its device. No similar products are approved now in the U.S. for children under age 5, Gandhi said.

Cost Justified

The cost is well worth the expense, Gandhi said. The children who get the device can wait on a normal hospital floor, rather than the intensive care unit, for a donated heart to become available. They also tend to fare well after the operation, which may save on future bills, he said.

There are risks to the surgery. More than half the children needed the external pump replaced at least once, often because of blood clots. Infections occurred in four of the nine children, and one device malfunctioned. While stroke and death rates were low in the study, so was the number of children treated, Gandhi said. Overall, about 75 percent of children survive until they receive a transplant, much better than their odds without the machine.

The findings were originally presented at the American Heart Association's annual Scientific Sessions last November.

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