A Bold Gamble in Tucson

By Claudia Wallis

It was well before dawn last Wednesday when Dr. Jack Copeland, the leading heart surgeon at Tucson's University Medical Center, had to face the grim truth: his patient was dying. Thomas Creighton, a 33-year-old Arizona auto mechanic, had undergone transplant surgery 24 hours earlier to replace a heart , ravaged by two heart attacks and cardiomyopathy, a progressive disease of the heart muscle. Right from the start there were problems with the transplanted organ, and a pacemaker had to be used. Then Creighton's body began rejecting the heart. At 3 a.m. he went into cardiac arrest.

As doctors struggled to keep the dying man alive, Copeland's assistants made desperate calls to organ-procurement agencies, hoping to find another human donor heart for him. None was available. Copeland then made a bold decision. He opted to use a virtually untested artificial heart to sustain Creighton until another human heart could be found--a direct violation of federal rules. There was no time, Copeland later said, to seek permission from the Food and Drug Administration, which regulates the use of medical devices: "If we had asked them to make a decision, the patient would have been dead."

Friday afternoon, despite Copeland's extraordinary efforts, Creighton died, having survived for eleven hours with an artificial heart and nearly 36 hours with a second human heart transplant. Had he fully regained consciousness, he would have learned that he had made medical history: in the space of four days his life had been sustained by four different hearts (including his own). Throughout the marathon medical battle the big concern was time. When Creighton's heart failed on Wednesday, he was put on a heart-lung machine, a device used to pump and oxygenate blood during heart surgery. The machine could be used safely for only three or four hours before causing serious damage to blood cells and ultimately to vital organs.

As Creighton's time on the heart-lung machine ticked on with no donor heart in sight, Copeland got permission from the patient's family to try an artificial heart. He called Heart Surgeon Cecil Vaughn of St. Luke's Hospital in Phoenix, who for two years has been experimenting with the "Phoenix heart," the invention of Kevin Cheng, a dental surgeon. Vaughn was stunned; the heart was years away from FDA approval and had been tested only twice in animals. "It was like a bomb falling from the sky," he recalls. Still he agreed to helicopter to Tucson immediately with Cheng and his invention.

But before Vaughn took off, he telephoned Dr. Donald Olsen of the University of Utah in Salt Lake City, asking him to join the rescue effort. Olsen was a member of the team that first tested the Jarvik-7 heart, which sustained Barney Clark for 112 days and was, at week's end, still beating in William Schroeder and Murray Haydon at the Humana Hospital in Louisville. Although Olsen was well aware that famed Surgeon William DeVries is the only doctor authorized by the FDA to implant the Jarvik-7, he agreed to fly to Tucson with the device. Said he: "In critical situations like this, we have to respond."

It was a case of first come, first served. Vaughn arrived in Tucson at 9:30 a.m. on Wednesday, 3 1/2 hours ahead of the Utah team. By then, Creighton had been on the heart-lung machine for nearly six hours. Says Vaughn, the choice was clear: "Either we try the artificial heart or we turn off the machine and tell Creighton's mother that her son is dead." After three hours of surgery, the pump was in place.

Like the Jarvik-7, the Phoenix heart runs on compressed air from a bulky external unit. The test model was built by Cheng in his spare time with limited funds and is 25% larger than a human heart. So large, in fact, that Creighton's chest had to remain open--though swathed in protective materials --for the eleven hours the device was in place.

The Phoenix heart sustained Creighton long enough for another human heart to be found and implanted. But it soon became clear that the ten hours he had spent on a heart-lung machine had taken their toll. As a result of blood- vessel damage, fluid had accumulated in his lungs, causing a buildup of pressure on the right side of his new heart that ultimately proved fatal.

"We did all we could," Copeland told reporters after the death. "As a physician, my conscience is clear." Though the FDA initially expressed disapproval of Copeland's actions and has demanded a written explanation, the agency said at week's end that it did not "contemplate any drastic penalty" for the surgeon or his hospital.

As Government officials, doctors and theologians debated the ethics of Copeland's actions, Creighton's mother and sister made their feelings clear. They thanked the doctor and the hospital staff for doing "everything within their human power to give him a life" and expressed the hope that the Phoenix heart experiment "would pave the way" for other heart patients in need. "We are thankful," they said, "that it was available for Tom."

With reporting by Melissa Ludtke/Tucson, with other bureaus