Transplant patient Thomas Creighton died Friday at the University of Arizona Medical Center after a marathon series of surgeries in which he received two human hearts and an artificial heart implant.
Creighton died at 2:20 p.m., nearly 36 hours after university surgeons had removed a controversial artificial heart and given him a second human heart transplant.
The artificial heart had been implanted in the 33-year-old auto mechanic's chest Wednesday afternoon as an emergency procedure after the first heart transplant--performed the previous day--failed to function normally.
Device Wasn't Approved
The artificial heart, designed by Phoenix dentist Kevin Cheng, did not have the endorsement of the Food and Drug Administration, which under a 1976 federal law must approve the use of experimental medical devices.
The use of the unapproved device raised ethical and legal questions of whether surgeons should be allowed to use artificial hearts in emergencies, even without FDA approval.
Creighton's mother, Dorothy, who declined to give her current last name, told a news conference after her son's death that "there are legal aspects and there are humane aspects" to the controversy.
She said she hopes that an artificial heart will be available to save future patients awaiting heart donors. "I hope they won't have to be on a (heart-lung) machine like Tom was," she said.
During a delay in obtaining the artificial heart from Phoenix after the failure of Creighton's first transplant, his circulation was maintained by a heart-lung machine.
According to Dr. Jack Copeland, the surgeon who performed the two transplants and took part in the artificial heart implant, Creighton's 10 hours on the machine were responsible for the accumulation of fluids in his lungs. This condition, called pulmonary edema, was responsible for Creighton's death, Copeland said.
Creighton's mother said that "there is no question but that all the doctors and nurses did everything in their power to give him a life. We appreciate what was done. They are terrific people."
Informed of His Chances
She said she and her daughter, D. Anne, who stayed in the hospital during the surgeries, were "fully informed" in "as much detail as possible" about the consequences of the procedures, the patient's chances and what the results might be.
She said the use of the artificial heart on her son, a divorced father of two children, was a "marvelous opportunity" to save his life.
Alethea Caldwell, chief executive officer of the university medical center, said the FDA is sending a team to conduct a fact-finding inquiry of the use of the artificial device at the university.
Caldwell said that the Phoenix team that helped the University of Arizona surgeons implant the device--Cheng and Dr. Cecil Vaughn--will come to Tucson for the inquiry. The surgeons have consistently maintained in questioning by newsmen that they had no choice but to use the artificial device or else let Creighton die.
Cheng, who immigrated from Taiwan 12 years ago, said he wishes there had been more time to decide whether to use his device. But, he said, "There was no time for deep thinking."
Jarvik-7 Heart Brought In
The university surgeons had also sent out a request for an artificial heart to two University of Utah researchers. One hour after the operation to implant the Phoenix heart began, Dr. Donald Olsen and Stephen Neilsen of the University of Utah arrived in the operating room with a Jarvik-7 heart.
It was a Jarvik-7 heart that was implanted in Barney Clark two years ago at the University of Utah and subsequently in two other patients in Louisville by Dr. William DeVries.
The Jarvik heart is the only such device licensed by the FDA, and DeVries is the only surgeon authorized by the FDA to implant it. The heart is manufactured by Symbion Inc. of Salt Lake City.
It was learned Friday that before leaving Salt Lake City, Olsen had gotten the approval of Dr. William Gay, chief of heart transplants and artificial hearts at Utah.
Olsen also had notified officials at Symbion of the plan to install the Jarvik heart in the dying Tucson patient.
According to John Dwan, a University of Utah spokesman, a telegram from Symbion awaited Olsen upon his arrival in Tucson saying that he did not have the company's permission to use the device here.
Heeding FDA Regulations
By piecing together information revealed by Dwan and Copeland, it is apparent that Symbion forbade Olsen to allow use of its heart lest that use by unauthorized surgeons interfere with FDA approval. At present, the FDA has approved its use on only seven patients--three of whom already have received it.
Copeland told newsmen that before implanting the Phoenix heart, he received a call from Dr. Willem Kolff, one of the developers of the Jarvik heart, who also expressed concern that its use by unauthorized surgeons might jeopardize Symbion's hope for further FDA approval.
Creighton's case raised a question that is of concern to all heart transplant surgeons who may require an artificial heart to maintain a patient awaiting a donor after his own heart has failed.
"The question," Dwan said, "is whether surgeons have the obligation to do everything to save the life of a patient, or do we have to get FDA approval?"
University of Utah Operation
Ironically, the first heart transplant ever done at the University of Utah was performed early Friday morning by Gay, the surgeon who gave Olsen permission to go to Tucson.
Dwan said Utah surgeons wonder what would happen if their transplant patient rejected his heart and required the Jarvik heart to keep him alive until a new donor is located.
Even though DeVries, the only surgeon with FDA approval to use it, has moved to Louisville, would his former colleagues at Utah use the heart anyway?
"The question is as yet unanswered," Dwan said.
William Grigg, an FDA spokesman in Washington, said it was unlikely that the agency would issue anything harsher than a reprimand to the Arizona hospital "unless we discover more inadequacies than are now apparent."
The 1976 medical devices law provides no special exemptions for emergencies such as these, Grigg said, "although we do take them into consideration" when applying the statute.
"If a man drives a car through a red light, clearly that's against the law," Grigg said. "But the police and the judge might take into account why he did it--if he was taking his wife who was bleeding to death to the hospital--he certainly wouldn't be convicted for running a red light."
Contributing to this story was Times staff writer Marlene Cimons in Washington.