Doctor Says Unapproved Artificial Heart Did Not Lead to Death
TUCSON, Ariz. (AP) _ Use of an unauthorized artificial heart did not contribute to the death of a 33-year-old auto mechanic, but in fact improved his condition as it kept him alive between heart transplants, a surgeon says.
Dr. Jack G. Copeland, chief of the University of Arizona’s heart transplant team, attributed Thomas Creighton’s death Friday to heart failure due to pressure from fluid-filled lungs. Autopsy results were expected today.
The Tucson man died after a four-day ordeal during which a heart transplant failed and the experimental Phoenix Heart was implanted in his chest Wednesday to keep him alive for a second transplant, although the device lacks approval of the U.S. Food and Drug Administration.
Copeland blamed the presence of fluid in Creighton’s lungs on the use of a heart-lung machine when he went into cardiac arrest 22 hours after receiving his first transplant Tuesday.
After Creighton was on the machine for about eight hours, the artificial heart, invented by Dr. Kevin Cheng, a Phoenix dentist, was implanted. It kept him alive while doctors searched for the second human heart.
Creighton’s condition actually improved on the device, Copeland said.
″I believe that the interim heart improved his physiologic status during the 11 hours that it was used.,″ he said. ″He had excellent pulses in his hands and feet and good color.″
The fluid in Creighton’s lungs also was a factor in the decision not to seek another heart as the second one began to fail Friday, he said.
The mechanical heart had not been approved by the FDA, and the University of Arizona Medical Center, where the operations were performed, had not been approved for an artificial heart operation.
The FDA criticized Copeland and Dr. Cecil Vaughn, who implanted the device, but agency spokesman William Grigg in Washington said it was unlikely that stiff sanctions would be imposed.
FDA investigators are expected to arrive next week, said hospital administrator Alethea Caldwell.
Copeland said he did not foresee ″an inquisition″ from the agency, only federal help in getting artificial hearts and FDA approval for future use.
Creighton’s mother Dorothy defended Copeland, saying he ″put his neck on the line″ in trying to save her son. She compared the first use of the device in a human to the first space launches.
″No living person had been in them before, either,″ she said.
She praised Copeland and the hospital staff and said she and Creighton’s sister, identified only as D. Anne, were ″fully informed″ of the procedures, their consequences and of Creighton’s chances for survival.
Before Creighton entered the hospital for the initial transplant, his mother said, ″he had virtually no life. He was existing.″
Creighton, a divorced father of two, suffered a major heart attack about 31/2 years ago, ″and he just got continually worse after that until he reached the point where he needed a heart transplant,″ his sister said.
The family planned private funeral services.
Criticism of Copeland’s handling of the case also came from members of the medical community.
″If Copeland had been prepared the patient wouldn’t have had to spend 10 hours on the heart-lung machine and wouldn’t have suffered all that damage,″ said George J. Annas, professor of health law at Boston University College of Medicine.Annas said he was not criticizing Copeland’s motives.
″We all want to see people’s lives saved,″ he said. ″But this is not the way. We’ve got this all mixed up.″
Copeland told reporters, however, ″It’s pretty hard to be prepared with a total artificial heart unless you have a program. We did everything that we could for him... My conscience is clear.″
He said he would like to have another artificial heart or a ventricular assist device - an apparatus that replicates half of a heart - ″on the shelf ready to go.″
Copeland repeatedly said the artificial heart was Creighton’s only chance to live. The doctor said he also warned Creighton’s mother and sister the artificial heart ″might be the last event in his life.″