Artificial Heart Gets Limited FDA Approval

Despite outcomes that many experts viewed as a checkered at best, most of the patients and close family members said the time gained was valuable -- a judgment that appeared to help sway FDA officials.

"Just being able to ambulate, to clearly communicate with loved ones, and to celebrate family events is in the view of many patients and family members a significant improvement in quality of life," said Bram D. Zuckerman, director of the FDA's office of cardiovascular devices.

Before getting the device, all of the patients were essentially bed-bound. Some were breathless even while lying still. A few were attached to devices called balloon pumps that mechanically enhanced the amount of blood flowing to the body with each heartbeat.

By increasing the flow of blood and oxygen to the brain, vital organs and muscles, the artificial heart made many of the patients feel better than they had in months (at least until complications intervened, in many cases.) Michael R. Minogue, Abiomed's president, said that 11 of the 12 patients who survived surgery "reported improved interaction with their families" and eight of 12 had higher levels of activity, which ranged from getting from a bed to a chair to walking with assistance.

Six of the 12 died of strokes. More than three-quarters of the patients could not take anticoagulant drugs because of other serious conditions, and without anticoagulants, clots tend to form on implanted hardware. That can cause a stroke if the clot moves to the brain. An improvement in the design after the fifth patient reduced the risk of clotting, Minogue said.

The original patients all had a life expectancy of a month or less when the device was put in, and their net gain in longevity was 4.5 months. The "incremental cost-effectiveness ratio" of the treatment -- assuming a total cost of $350,000 -- was $940,000 per year of life gained.

"In the opinion of most health policy experts, that is not a cost-effective use of resources," said Sean D. Sullivan, director of the Pharmaceutical Outcomes Research and Policy Program at the University of Washington. "Most cancer biologics [biotech drugs] that extend life by four to five months are about one-third or one-quarter the cost of this artificial heart."

Other experts also wondered about the value of the investment.

"We are talking about a potentially very, very expensive therapy for a very common disease," said Alan M. Garber, a physician and cost-effectiveness expert at Stanford University who added that $200,000 to $400,000 "will go a long way toward vaccinating children and helping people with hypertension get better treatment -- things that are of proven benefit but cost much less."

He said, however, that there may be a benefit in bringing to market -- and paying for -- an extremely expensive device on the assumption that it would develop into a cheaper and better one.

Abiomed officials say their second-generation device, now being tested in animals, will have a target life of five years, compared with 18 months for the current AbioCor.

The first "permanent" artificial heart was implanted into Barney Clark, a 61-year-old retired dentist, in December 1982. It was powered by a 400-pound air compressor. Clark survived 112 days and suffered many complications.

Staff researcher Madonna Lebling contributed to this report.