A Year Later, the Beat Goes On: Clinical Trials of the AbioCor in Seven Very Ill Patients Have Yielded Some Crucial Lessons in Surgical Techniques and Postoperative Care
Underwood, Anne, Newsweek
Byline: Anne Underwood
When Gom Christerson entered Jewish Hospital in Louisville, Ky., last September, he was willing to do almost anything to save his life from his failing heart. "I'll try anything but that," he told cardiac surgeon Laman Gray Jr., nodding to a model of the shiny new AbioCor artificial heart on Gray's desk. But over the next 10 days the AbioCor turned out to be his only option, and Christerson reconsidered--after he learned that the new heart would allow him to abandon his hated low-sodium, low-fat diet and go back to eating seafood and barbecued ribs. Nine months later, Christerson, 71, is home in Central City, Ky., enjoying the best quality of life that he's had in a long time. He plays cards with his friends, visits the local barbershop to catch up on news and chows down on ribs. And best of all, on May 16 he saw the birth of his first great-grandchild, a girl named Ellen Thomas in his honor.
A year ago NEWSWEEK put the AbioCor on its cover. Since then, seven terminally ill men have received the heart as part of a clinical trial. Of those, only two are still alive, including Christerson. And three of the patients have had strokes, apparently related to a design problem that has now been corrected. As a result of the strokes, the trial was briefly suspended. To the layperson, that record may not appear impressive. But doctors point out that no new medical invention performs flawlessly in its first trials. Heart-assist devices, to name just one, have now been implanted with great success in thousands of patients. "But of the first 10 we did here, maybe two worked," says Gray. The AbioCor did more than just work. Within five months of becoming its first recipient, patient Robert Tools had enough energy to talk of starting a new job. (He died in November.) It sustained another patient through gallbladder surgery and a third through lung problems that his natural heart could not have endured. "Its performance has been truly remarkable," Gray says, "and will only improve over time."
For now, doctors are still on a steep learning curve, refining surgical techniques and perfecting regimens for postoperative care. But their greatest challenge has been preventing strokes. Abiomed, the heart's manufacturer, halted implantations in January to ferret out the source of the problem. It turned out to be four plastic struts that crisscrossed over the heart's left in-take valve. The designers had added these struts for technical reasons when the heart was still being tested in calves. But in people, the struts merely provided a static component on which blood could potentially clot, with the clots later breaking off and traveling to the brain to cause strokes. It was a simple decision to take them out, and in April, Abiomed resumed the clinical trial.
The heart has now beat 1.5 billion times in its various recipients without a single mechanical malfunction. "When the software geniuses at Microsoft design a new program, they can't claim that kind of reliability," says Dr. …