FDA Approves Artificial Heart For Those Awaiting Transplant

Doctors Hail the $100,000 Device, but Critics Question Whether Cost Is Justified

Federal regulators approved use of an artificial heart yesterday, marking the first time a mechanical device has been made widely available to replace a failing human organ.

In contrast with early hopes of permanently replacing an ailing heart with a man-made pump, the new device substitutes for the bottom half of the heart and can be used only to sustain critically ill patients in the hospital until they can get a heart transplant.

But the CardioWest Total Artificial Heart offers hope to the dozens of Americans who would otherwise die each year without it, and its approval by the Food and Drug Administration was hailed as an important, long-sought moment in the troubled quest to replace the human heart with a machine.

"It's a milestone," said Robert Jarvik, whose Jarvik-7 heart electrified the world when it was implanted in Barney Clark in 1982. "It's a shame it took so many years. But this is very gratifying."

The approval of the device, an updated version of the Jarvik-7, could help invigorate the field, which has seen a flurry of activity in recent years with the development of a new, totally implantable artificial heart and a variety of pumps that can sustain patients dying of heart disease -- the nation's No. 1 killer, Jarvik and others said.

"It's remarkable, and I think very worthwhile and very encouraging for the whole field," said heart surgeon Michael DeBakey of the Baylor College of Medicine in Houston. "This shows that we're moving along and progress is being made."

But critics questioned the value of the $100,000 device, saying it will only add expense to the nation's already bloated health care bill without increasing the number of heart patients who survive.

"From an individual's perspective, it's a wonderful thing -- it can help an individual survive," said medical ethicist George J. Annas of Boston University. "But from the medical system's perspective, it's a useless device. The number of lives you save with heart transplants is limited by the number of hearts that are available. And this does nothing about that."

About 4,000 Americans need heart transplants every year, but only about 2,200 donor hearts are available. Small implantable pumps can keep some patients alive while they await transplants by supplementing their weakened organs. But some patients -- the FDA estimates about 100; SynCardia Systems Inc., which developed the new device, estimates several hundred -- need something more because both sides of their hearts are failing.

"This is a parachute device that can save the lives of patients who have no alternatives," said Marvin J. Slepian, a cardiologist and chief executive officer of Tucson-based SynCardia.