Portability in works for artificial hearts

Europeans who have been implanted with an artificial heart can go home fairly quickly to wait for a human-heart transplant. In the United States, artificial hearts and those who need them never leave the hospital, due to the large devices that power the heart.

Early next year, one artificial heart manufacturer, SynCardia, plans to ask the U.S. Food and Drug Administration for permission to test a "universal driver" that's similar to what Europeans use. The company already has lined up hospitals — including Intermountain Medical Center — and is training the medical teams in use of a portable driver. All it needs is FDA approval to run the device through trials as a step toward full approval.

But that's not a slam dunk, according to SynCardia executives who held a press briefing during the "Dr. Barney Clark and 25 Years of Advancements" symposium commemorating the day Clark received an artificial heart at the University of Utah in 1982.

The two-day symposium, sponsored by the U. and the Utah Artificial Heart Institute, has attracted a veritable "Who's Who" from the circulatory and artificial mechanical heart support field. The event includes looks back at progress made to date and updates on ongoing and planned efforts.

Dr. Jack Copeland, a heart innovation pioneer from Tucson and medical director of SynCardia, describes an "environment where fear of harming is perhaps more predominant than the desire to help." He said his company and others are "frustrated with the slow pace" of FDA approval for medical innovation.

The fault lies in part with the American propensity to sue, said Copeland and Richard G. Smith, company chief scientific officer and co-founder. Medical innovations move faster in Europe because of "their regulatory environment and lack of a litigious society," he said.

"As long as people are suing each other at the drop of a hat," added Copeland, "it's unlikely the FDA is going to change."

The advantage of a portable driver exceeds the comfort of being at home. On portable heart drivers, patients are able to exercise and do fun things and more fully participate in their lives. And as they do those things, they become healthier, which puts them in better shape when it's time for a human heart transplant.

Eventually, Smith said, they would like to see drivers that weigh as little as 6 pounds and have batteries that last up to eight hours, for true portability. "Then it's just managing the power" of the device.