Mechanical-heart patient comes to regret his life-saving choice

Philadelphia Inquirer

By Stacey Burling

It has been eight months since James "Butch" Quinn's ailing heart was replaced with a machine, and he has spent all but three weeks of it in Hahnemann University Hospital.

Doctors said that without the artificial heart he almost certainly would have died months ago. Yet because of all that time away from his home in West Philadelphia and disappointing quality of life, Quinn now questions his decision last year to become one of the first humans to test a new type of fully implantable mechanical heart.

"I don't believe I would do it again simply because it's too much afterwards, you know," Quinn said in a soft, raspy voice from his ICU bed last week.

Quinn healed remarkably quickly in the days following his Nov. 5 surgery. He was able to leave the hospital in January for the nearby Hawthorn Suites despite a small stroke. But severe pneumonia brought him back and he's had bleeding problems caused by blood thinners meant to prevent more strokes. He was on a ventilator until the end of June and still receives extra oxygen through a tube in his throat. Because of the bleeding, his doctor, heart surgeon Louis Samuels, has taken the unusual step of stopping the blood thinners.

"I've gone through quite a bit since the surgery. I've gone through more than any man can stand or bear, really," said Quinn, a retired baker and Vietnam veteran. "It's hard and very difficult day to day not knowing what to think. They tell me one thing and my body is feeling another."

Still, he said, he's never thought of quitting. "I have a lot of fight in me," he said. "I don't know how to give up."

But would he do it again, the way he's feeling right now? No.

Quinn said he has prayed for Tom Christerson, the Kentucky man who went home in April, seven months after receiving the device, and still hopes that he, too, will be able to go home. Of the six men given the heart since last July, only Quinn and Christerson are still alive.

Abiomed, the Danvers, Mass., company that manufactures the machine, has since modified it. No one has gotten an AbioCor heart since April. The company is now working to make monitoring equipment more suitable for homes - more maneuverable, for example, and with fewer but louder warning beeps.

The number of heart transplant operations nationwide, about 2,000 a year, now is limited largely by the availability of donated cadaver hearts. Far more people need them, and many die waiting. Quinn was too sick to qualify even if a cadaver heart had been available.

Edward Berger, Abiomed's vice president for strategic policy and planning, said the mechanical heart's clinical trial is continuing. Indeed, he said, the company hopes to do "a significant number" of the eight more authorized implants this year.

Berger said the company did its best to prepare people who enrolled in the trial, all of whom were deemed likely to die within a month, for all the possible complications. It appointed an independent group of patient advocates to help potential study subjects understand the trial. Nonetheless, it's to be expected that some would be dissatisfied, Berger said.

"When things go well, patients and their families are going to be extraordinarily happy," he said. "When things don't go well, it is absolutely understandable that patients or their family are going to be distressed... . James has had a very difficult last few months."

Both surgeon and patient have described what happened when Quinn got the artificial heart as a deeply religious experience. After a rough first week, Quinn bounced back and quickly became the healthiest and most vigorous of the recipients - a "poster boy" for the heart, as Samuels put it.

In December, Quinn said his life felt "altogether new." He said: "Life is beautiful."

Soon after celebrating his 52d birthday at the hospital June 30, he told CNN that getting the mechanical heart has been "very meaningful and I would do it again."

But last week, in his first interview done without medical staff present, Quinn said he had changed his mind. He has received good treatment, he said, but has been away from home too long.

"I think that's the best quality of life, is to be at home in my own surroundings, be with my family." He said he wants to have "rigorous confrontations" with his grandbabies. "They're the best therapists in the world.

"The more I lie here, I get sick," he said. "It's like the bed's draining me."

Samuels said he understands, and thinks Quinn's unhappiness stems largely from being "cooped up" in the hospital so long. In fact, he said there is no medical reason for Quinn to be in the hospital. He wants to get him home by early August, but said it has been complicated to arrange for qualified 24-hour nursing and modifications to the home Quinn shares with his wife, Irene.

Samuels said Quinn's medical condition has improved more than he realizes. He's still very weak, but it was an achievement to wean him off the ventilator. "The situation we have now is a thousand percent better than we had even a month ago."

Quinn and his wife still speak fondly of Samuels. "He's been here for me and he's talked to me," Quinn said. "He's tried to uplift me when my spirits were down."

Patients in the trial are required to have a strong support system, but their very closeness is one thing that has made Quinn's long stay in the hospital difficult for him and Irene, a rail-thin nurse's aide who is 55, but looks far younger.

The couple have been married nearly 23 years. She calls them "two peas in a pod." He calls her "more than my better half."

Watching helplessly while her husband suffers through one medical problem after another has been "like a nightmare," she said.

"If I would have known," she said, "he would have never got it done. I don't think anybody should ever get it done."

Every day, she said, "every time I go to the hospital, I cry. I cry before I get in there and I cry when I get out."

James Quinn said he thinks the experience has been harder on Irene than on him, and that's one reason he now questions his decision. "She's a tough old bird and I love her to death," he said, "but I can see the breakdown in her eyes. I know she's unhappy... . I feel it all the way through me."

Irene Quinn said she did not realize just how experimental the AbioCor heart was. And, while she was aware that many serious complications were possible, she said she thought her husband either would die quickly or return home in better shape than before the surgery. She never imagined months of isolation in the hospital.

Alan Milstein, a Pennsauken lawyer the Quinns have hired as an adviser, has concerns about what potential patients are told about clinical trials. He represented the family of Jesse Gelsinger, who died in a gene-therapy experiment, in a suit against the University of Pennsylvania.

Milstein believes patients should be told clearly that they will be subjects in a "human experiment" and that the goal of the experiment is not to make them well, but to test technology for future patients.

People who join such trials often feel, as Quinn did, that their only choice is between the experimental treatment and death. They grab at the chance to live, said Milstein. In reality, "We all know that the purpose of the research experiment is to perfect this product so that it can later be sold."

E. Haavi Morreim, a professor in the department of human values and ethics at the University of Tennessee who chairs Abiomed's patient advocacy program, said the advocates discovered that most patients have entered the process with their minds already made up.

"They come to get the heart," she said. The advocates have done their best to help patients understand everything that could go wrong. (The Quinns dismissed their original advocate and have since chosen a medical anthropologist and ethicist who is independent of Morreim's group.)

But because this is brand-new technology, it's difficult to tell people what to expect. "What we have is the very cutting edge here and there isn't anything typical yet," Morreim said.

George Annas, a professor of health law and bioethics at Boston University, calls clinical trials like this one "experiments on families." He said any potential subjects from now on should be required to talk with people who've already gotten the heart and their spouses.

What would James Quinn tell them?

"Think," he said. "Think and then do some more thinking."