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Texas Implant Never Reported To Public

December 19, 1986

PITTSBURGH (AP) _ Surgeons in Texas made no announcement when they implanted an artificial heart in a patient two months ago, or when the man died four days later of liver failure.

It is the first known instance in which an artificial heart implant at a U.S. hospital was not reported to the public, and the lack of an announcement raises questions about how much the public is entitled to know about medical experiments.

″We don’t consider it an unusual event,″ Dr. O. Howard Frazier, who performed the implant with Dr. Denton A. Cooley, said of the Oct. 13 operation at the Texas Heart Institute in Houston.

″Any research program, any ... study you do, any treatment with terminal illness is confidential and not scientifically reported until there is something of consequence,″ Frazier said in a telephone interview Wednesday.

But Dr. John Watson, chief of the National Heart, Lung and Blood Institute’s devices and technology branch, said there was a public interest in being informed about such procedures.

″I think there’s a need for the public to have some sort of information about how public funds are being used in medical research. It’s our money,″ Watson said.

Federal funds were used in the research and development of the artificial heart.

″There is a duty certainly to disclose information about experiments that involve devices that require special approval,″ said Arthur Caplan, associate director of The Hastings Center, a research institute that studies ethical problems in health care.

Others, like the University of Utah’s Dr. Don Olsen, who assisted in Barney Clark’s permanent artificial heart implant in 1982, aren’t so sure.

″It’s time for the various people doing the artificial hearts to be able to do the studies that they’d like to do on the patient and to present the information in the medical literature,″ Olsen said.

The results of medical research generally are reported first in scientific journals, and Olsen said he would expect Frazier and Cooley to publish a paper on the October operation.

Olsen said he originally had suggested that the historic operation on Clark be kept a secret until 24 hours after it occurred and that the patient’s identity be withheld.

″It was pointed out to me that such possibilities were out of the question,″ he said. ″But I’m glad now that every patient who receives an artificial heart is not on the menu for the evening news.″

Fifty-one artificial hearts have been implanted in patients in seven countries since Cooley first performed the procedure in 1969, according to Olsen, who keeps a world registry of artificial hearts. Thirty-nine have been performed this year.

In the Oct. 13 operation, the surgeons implanted a Jarvik-70, a scaled-down version of the Jarvik-7, into a 48-year-old man, according to Phillip J. Carter, a spokesman for Symbion Inc., the devices’ manufacturer.

Amid publicity eight months earlier, Cooley and Frazier had implanted a Jarvik-7 into Harris Kent, a 41-year-old retired Army major from El Paso, Texas.

Kent was sustained for 31 days by the pump before receiving a human heart March 6. He remains hospitalized.

Because of liver failure, the second patient was too ill after implant surgery to be considered for transplantation, Frazier said. The man died Oct. 17.

The implant was reported immediately to Symbion. Also notified was the U.S. Food and Drug Administration, which had allowed the institution to implant the device.

Otherwise, few knew what had happened.

″I didn’t know there was an implant,″ Texas Heart Institute spokeswoman Patti Jamison said this week.

A Dec. 5 medical journal article listing U.S. implants through November did not include the Texas operation.

With nine artificial heart implants to its credit, more than any other institution in the country, Presbyterian-University Hospital of Pittsburgh occasionally has withheld patients’ identities at families’ request, and once waited 14 days to announce an operation.

What would the hospital do if the patient insisted the implant never be publicized?

″That’s a worse-case scenario we’ve never had to handle,″ said Tom Chakurda, a spokesman for the Pittsburgh hospital. ″We’d eventually ask the family for permission to at least allow us to confirm the initiation of X- number of procedures and simply put it at that.″

Donna Hazle, spokeswoman for Humana Hospital-Audubon in Louisville, Ky., said artificial heart recipient Murray Haydon refused direct contact with reporters.

Haydon, the third person to receive a permanent artificial heart, died June 19 after 488 days on the pump.

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