Missing a Beat in Washington

The FDA rejects the artificial heart--for now

Heart transplants are sometimes the only hope for people dying of heart disease. But such operations are expensive, donors are scarce, and the recipient's body often rejects the new organ. Fewer than 50 transplants are done in the U.S. each year, and only 50% of patients survive five years. A more dazzling option seemed imminent when researchers from the University of Utah announced last month that they were ready to implant artificial hearts in humans. Only one hurdle remained: permission from the Food and Drug Administration. But last week the FDA rejected their application--for the time being at least.

The agency cited several problems with the proposal. First was concern over when and how doctors would decide to implant the plastic and aluminum device. The Utah team said it would try the procedure only as a last resort, when a patient's heart could not take over for the heart-lung pump used during surgery. But the FDA suggested that the doctors first consider using a less drastic mechanical aid, the so-called assist device. This piece of equipment leaves the natural heart intact but takes over the operation of one of the pumping chambers, usually the left ventricle, giving it a chance to recover and resume functioning. Says Cardiologist Melvin Cheitlin, who headed the FDA advisory panel that evaluated the device: "Once you've taken someone's heart out, you've really burnt the bridge."

The FDA also wondered whether the patient consent forms proposed by the Utah doctors fully spell out the kind of life the implant recipient should expect. The heart runs on compressed air and is electrically powered. That means the patient will be permanently tethered to air hoses and plugged into an electrical outlet, a sedentary, chair-to-bed existence.

Another issue is the difficulties posed by the bulky support equipment, including a refrigerator-size air compressor. Says Cheitlin: "There was discussion about the logistics of getting the power source into the operating room and eventually into the home. What about backup systems for the home?" Some implant recipients may later be considered for heart transplants at Stanford University. "How," asks Cheitlin, "will they get them from Utah to California?"

Finally, the FDA believes the proposal does not go into enough detail on what, if any, information will be gathered after the implant. Will the researchers, for example, record the effect on the blood, measure exercise tolerance of the patient, or monitor the new heart's pumping ability?

The FDA did not concern itself with some of the longer-range questions about the artificial heart, such as how to pick recipients or how to pay for implants (upwards of $50,000). William DeVries, the surgeon who hopes to do the first operation, and Robert Jarvik, who designed the device, hope that a revised application can be submitted within two months. Cheitlin was most encouraging about their chances: "They are going to come through with an acceptable proposal. I don't see any problem that it will eventually be granted." qed

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