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Monday, October 15, 2001

Artificial heart won't fit


One woman's struggle shows AbioCor has serious limitations

By Dick Kaukas
The Courier-Journal

        YELLOW SPRINGS, Ohio — Lauren Heaton's heart is failing, yet the now world-famous AbioCor artificial heart can't help her. The 26-year-old's rib cage is too small to accept the softball-sized implant.

        The 5-foot-4-inch woman who weighs about 120 pounds was tested last month for a possible implant at Jewish Hospital in Louisville on her doctor's recommendation. But even before the test, Ms. Heaton says, she had her doubts about the heart after seeing news reports.

        “I was looking at that huge contraption on TV, and I thought, there is no way that thing could ever fit in my chest,” says Ms. Heaton, a leukemia victim who has endured a string of difficult medical decisions, treatments and setbacks over the past five years.

        Analysis of a chest X-ray last month verified Ms. Heaton's misgivings — it showed that the plastic and metal heart was too large for her rib cage. Although she was so ill her doctors worried whether she had much time to live, Ms. Heaton could not be considered for the implant.

        Since then, her condition has improved slightly. But her fleeting experience with the AbioCor implant illustrates its most serious limitation, as well as the hope it can offer people like Ms. Heaton who face death.

        The size of the device is a practical obstacle that the AbioCor's designers say they always realized, but was impossible to avoid, at least for now. A smaller version is “a couple of year's away,” says Abiomed spokesman Ed Berger.

        The present size was dictated by development contracts with the National Heart, Lung and Blood Institute, which wanted to be sure the heart could pump adequate amounts of blood and specified that it must have a capacity of 10 liters per minute, “which is what a large human being needs for normal and moderate activity,” Mr. Berger says.

        When it became clear from the first three implants, all performed since July 2, that the device appears to be working as designed, the company “kicked into high gear” a new project to reduce the size of the heart by as much as 30 percent.

        “A smaller person needs lesser output, so a downsized heart should give an equally good result,” he adds.

        When Ms. Heaton, who lives with her mother and father, Kazuko and Tim Heaton, was told that the AbioCor wouldn't fit her, she felt “both disappointment and relief at the same time.”

        She would have liked to have the option of receiving an artificial heart if she had met the other requirements. But she knew the surgery and recovery would have been arduous, and she already had endured several challenges.

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        Last March, she was diagnosed with congestive heart failure, a result of the medication she had been taking to fight leukemia. Her doctor, Lynne Wagoner, director of the transplant program at University Hospital in Cincinnati, said long-term use of the drugs is “a well-known cause of heart failure.”

        A few months later, Dr. Wagoner suggested that Ms. Heaton consider the AbioCor. At the time, Dr. Wagoner thought Ms. Heaton might have only a month or two to live.

        Dr. Wagoner talked to doctors in Louisville in early September. They agreed to start the process of considering Ms. Heaton for the surgery. She was X-rayed in Cincinnati to determine if there was room in her chest. A few days later Dr. Wagoner's office was notified of the results “her thorax just wasn't big enough.”

        Dr. Laman Gray, the University of Louisville surgeon, who with his colleague, Dr. Robert Dowling, implanted the first two AbioCor hearts, says he can't discuss specific patients or why someone might have been ruled out for the surgery.

        But he acknowledges that “it is very frustrating” when he and Dr. Dowling learn that the heart is too big for a patient who might benefit from it.

        Dr. Gray also reiterates that this is an experiment. “It's still not proven that it works and will prolong life, though we've had some positive indications.”

        Ms. Heaton's health problems began in 1996, while she was majoring in French at Carleton College in Minnesota. She was diagnosed with acute myeloid leukemia, a type of blood cancer that afflicts about 5,200 men and 4,800 women each year.

        She had chemotherapy, and the leukemia went away. “I thought that was going to be it,” she says.

        She returned to classes at Carleton, graduated in 1998, and moved to Paris, where she studied French and taught English to business people.

        She had a relapse and returned to Yellow Springs for more chemotherapy. Finally, in 1999, she had a grueling bone-marrow transplant in which her own bone marrow — and, in theory, all her cancer — was destroyed by medicine and radiation.

        “It took quite a while to recover from that,” Ms. Heaton says, “but I did.”

        She relapsed again last December.

        Her doctors thought she should have a second bone-marrow transplant, she said, but decided against it “because, I guess, they thought I couldn't sustain another one. You know, I'd probably die.”

        Her congestive heart failure was diagnosed in March, after she started feeling short of breath.

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        Ms. Heaton spent several weeks in University Hospital in Cincinnati before going home about two months ago.

        “I sort of exhausted everything I could do,” Dr. Wagoner says.

        A heart transplant wasn't possible because the drugs Ms. Heaton would have to take to keep her body from rejecting a new human heart also would increase chances that her cancer, now in remission, would return.

        “She's made steady progress,” Dr. Wagoner says. “She really pushes herself. If you look at how horrible her heart function is, and how low her blood pressure is, it's remarkable that she is walking around and feeling fine.”

        Ms. Heaton and her younger sister, Erika, who just finished college, sometimes play musical duets, Lauren on the piano and Erika on the cello. Lauren's a Chopin fan.

        For a while late last year, she worked as a free-lance reporter for a local newspaper and enjoyed it. But she's reluctant to return until she feels more confident of recovery.

        “Any day I could lose it again,” she says. “I could drop the ball and be back in the hospital. So, I feel uncomfortable making any kind of commitment.”

        Her condition doesn't weigh her down. She laughs easily and often. She cooks for her family. And she maintains a positive outlook without much apparent effort.

        “Everybody asks me how I can be this way,” she says, chuckling, “and I always say I can't help it. I say it's because I have an extra dose of endorphins,” the chemicals released by the brain that act as natural painkillers.

        Besides, she adds: “I expected to die years ago, so every day is kind of a bonus.”

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        The federal Food and Drug Administration has given Abiomed permission to implant five of the experimental hearts in patients with an estimated 30 days or less to live.

        The first three patients are continuing their recovery. Robert Tools of Franklin, Ky., had his implant July 2, and Tom Christerson of Central City, Ky., was operated on Sept. 13, both at Jewish Hospital in Louisville; an unidentified man received an AbioCor in Houston Sept. 26.

        If the first five implants go well, the FDA may approve 10 more; Abiomed has said it intends to perform the first 15 implants by the middle of 2002. Because of the AbioCor's size, it's likely that most of the first 15 patients will be men.

        But more women than men die each year from cardiovascular diseases, including congestive heart failure, according to the American Heart Association's 2001 statistical update — 503,927 women and 445,692 men.

        Abiomed has estimated that a smaller heart eventually might be implanted in 100,000 men and women a year.

        Kazuko Heaton said that if the AbioCor is downsized, she would urge her daughter to consider it again, if her condition warrants it. “As scary as it is, my hope is that she could hang on until they develop a smaller one,” she says.

        Lauren Heaton, who describes her mother as having been “at my side through absolutely everything,” laughed at the suggestion and said she hopes she can endure until then. “Last December, when I relapsed, I said, "OK. Maybe this summer when the weather's nice, I can go out happy.'

        “I've lasted through the summer. Maybe I could last even longer.”

       



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