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Of hearts and mind in emergencies.

Last week's furor concerning the emergency implant of an artificial heart not approved by the Food and Drug Administration (FDA) has raised several ethical and legal questions, including whether or not there should have been a furor at all.

Thomas Creighton, a 33-year-old auto mechanic, died March 8 after being given three consecutive hearts during three days of intense surgery at the University of Arizona hospital in Tucson. A surgical team led by Jack Copeland implanted the unapproved "Phoenix heart," developed by dental surgeon Kevin Cheng of St. Luke's Hospital in Phoenix, after Creighton's body rejected a first heart transplant. The artificial device sustained him for 11 hours until a new donor heart was found. Creighton died after the second donor heart was transplanted.

Some medical ethicists question the Arizona team's decision to use the Phoenix heart rather than the Jarvik-7, the FDA-approved permanent artificial heart developed at the University of Utah that has been implanted in three people since 1982. The Arizona team had requested the Jarvik-7, but the Phoenix heart (above) arrived about three hours earlier and was used because "something had to be done as soon as possible," according to a spokesperson for St. Luke's.

But all the facts are not yet in, says Bruce Jennings, associate for policy studies at the Hastings Center, a medical ethics institute in Hastings-on-Hudson, N.Y. "If the Arizona group was motivated to save the patient's life," Jennings says, "there's no justificiation for using a device that's untested if they can get their hands on a better device." the Arizona group, however, apparently would not have been on better legal ground if they had used the Jarvik-7. The FDA's 1976 Medical Device Act allows for emergency use of artificial hearts only if the doctor or hospital has filed for FDA approval. They had not.

Hershey (Pa.) Medical Center's "Penn State Heart," a temporary artificial heart designed to sustain patients during emergency situations like that in Tucson, is the only other artificial heart up for FDA approval. The FDA is expected to respond to that request this month. Last year, the agency approved clinical trials for Stanford University Medical Center's left-ventricular assist device, which takes over the heart's muscular workhorse, the left ventricle, during heart transplants or open-heart surgery. It will be implanted in about 10 patients before final FDA approval is sought. The Phoenix heart, made of the same material its developer uses to replace jawbones in facial reconstructive surgery, has been tested in calves for about two years. Clinical trials, a spokesperson for St. Luke's says, are "not yet even part of the protocol."

Nevertheless, the group's actions elicited sympathy for the plight of doctors in emergency situations. When it comes to going by the book or saving a life, most doctors would opt for saving a life, says Robert Bartlett of the American Society of Artificial Internal Organs (ASAIO) in Boca Raton, Fla. "If every doctor who improvised something had to go through FDA approval, it would be preposterous," he says. Last month, the ASAIO submitted a petition to the FDA to shorten the approval process for emergency use of experimental devices.

The FDA this week issued a mild reprimand to the University of Arizona hospital, and is conducting an investigation of the Arizona group's actions during the emergency.
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Title Annotation:emergency implant of unauthorized artificial heart
Author:Bennett, Dawn D.
Publication:Science News
Date:Mar 16, 1985
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