No FDA Action Planned Over Artificial Heart
While an auto mechanic clung to life after receiving three hearts--one artificial--within 48 hours, federal health officials indicated Thursday that they will not take punitive action against the hospital that used the man-made device without their approval.
The patient, Thomas Creighton, 33, was in critical condition at the University of Arizona Health Sciences Center, where the surgeries were performed by a team headed by Dr. Jack Copeland, with the assistance of doctors from St. Luke’s Hospital in Phoenix.
Copeland said he did not know how long Creighton could go on in his present condition. He noted that the patient had been healthy and relatively strong, except for his heart disease before the surgery. However, Copeland estimated that Creighton’s chances of surviving for any period of time were “less than 25%.”
11 Hours of Life
After Creighton’s first transplanted heart failed Wednesday, doctors used the artificial heart to keep the patient alive for 11 hours, until a second organ was obtained and transplanted.
The surgeons said they used the artificial heart because it was Creighton’s “only chance of survival.”
Food and Drug Administration officials had expressed concern Wednesday about use of the device without their approval or direct knowledge. However, on Thursday, FDA spokesman William Grigg said in Washington that it was “unlikely” that the agency would take action against the Arizona hospital.
“They informed us today that, in the heat of the time, they saw this as an individual life-saving procedure and had not planned it as part of an experimental program,” Grigg said. “They assured us they would apply to us if and when they do decide to carry out such an experimental program.”
He added: “We are in a situation where we want to be as compassionate as the law allows us to be, but we do not want a situation to develop in which doctors cut corners and patients are routinely experimented upon with neither safeguards nor useful information for the practice of medicine.”
The medical center’s chief executive officer, Alethea Caldwell, said the hospital did nothing to violate either FDA or university guidelines by allowing the surgeons to use a device that did not have FDA approval.
“We have not broken any statutes. We do not anticipate any actions by the FDA (against the university),” she said.
She said that in emergency situations such as the doctors found themselves with Creighton, medical judgment--not FDA statutes--prevails.
Before Wednesday, the artificial device employed here had never been used in a human and had been tested on two calves for only a few hours.
University spokesmen said Creighton has been receiving care at the health center since last May. Creighton had been diagnosed as having cardiomyopathy, a progressive heart disease, as well as an unstable heart rhythm.
The university did not release personal information about Creighton, except to say he is divorced and has been an Arizona resident for 18 years.
The immediate chief threat to Creighton’s life is the accumulation of fluids in his lungs, Dr. Allan Beigel, a university spokesman, said Thursday.
The accumulation of fluids, called pulmonary edema, occurred because Creighton was on the heart-lung machine for a total of 10 hours in between and during the three surgeries, Beigel said. He said problems normally begin to appear in patients kept on the machine longer than four to six hours.
“There are no problems with the new (transplanted) heart, but its functioning is being lowered by the pulmonary edema,” Beigel said. “The heart is not working as efficiently as it could because of the pulmonary edema.”
Copeland also expressed concern that Creighton, who has “reduced consciousness,” might have suffered brain damage during resuscitation efforts after failure of the first transplant.
Soon after that, about 5:30 a.m. Wednesday, Copeland contacted Dr. Cecil Vaughn, a Phoenix heart surgeon who had been working on an artificial heart similar to the Jarvik-7 model implanted in Barney Clark at the University of Utah and more recently in two patients in Louisville, Ky.
Designed by Dentist
Vaughn’s artificial heart, known as the Phoenix heart, was designed by Phoenix dentist Kevin Cheng.
In addition to contacting Vaughn, the University of Arizona team also called Dr. Donald Olsen, one of the developers of the Jarvik-7 heart, in Salt Lake City.
Meanwhile, the surgical team had launched an urgent search for a second heart donor.
By noon on Wednesday, when no new heart had been found, the Phoenix artificial heart was implanted by Copeland and Vaughn.
Olsen, taking with him a Jarvik-7 heart, also flew to Tucson but arrived after the operation to implant the Phoenix heart was under way.
“Dr. Copeland and I made the decision that the only chance of survival for this patient was to go ahead and get this pump in,” Vaughn said.
Both doctors have said the critical issue was to get the patient off the heart-lung machine as quickly as possible.
Copeland said that as he was getting ready to do the Phoenix heart implant, he received a telephone call from Dr. Willem Kolff of the University of Utah, another Jarvik heart developer. Kolff indicated that he had been in contact with the FDA about the situation, Copeland said. Kolff seemed “worried that we might use the Jarvik heart and jeopardize its approval by the FDA,” Copeland added.
As it turned out, the Utah surgical team arrived an hour after the Phoenix heart implant had begun and assisted as consultants during the procedure.
Copeland said he did not inform the FDA of his plans, because he did not “want to give anybody outside the team the opportunity to make a decision yes or no.”
“Time was of the essence,” he said. “We had a battle going on. If I turn to an agency and ask it to make the decision, we would lose.”
In a similar incident in 1981 when Dr. Denton Cooley, a Houston heart surgeon, implanted an artificial heart without previous FDA authorization, the agency took no action other than to tell Cooley he should have sought approval.
Under provisions of a 1976 federal law, the process to gain FDA approval for experimental programs takes 90 days, FDA spokesman Grigg said.
Caldwell, the medical center’s executive officer, declined to discuss who will pay the costs of either of the heart transplants or the artificial heart implant. Earlier, Beigel had told reporters that the patient’s first transplant was paid by Arizona’s Medicaid program, known as ACCESS. Medicaid is a federal-state program that pays medical bills for the poor.
Beigel said the program will not pay the expenses for the artificial heart implant, and he was not certain who will pay the cost of the second heart transplant.