Select Hospitals Offering Alternative to Heart Transplants

So far, Thoratec, which makes the one device that has received FDA approval for destination therapy so far, the HeartMate XVE, has a 72% survival rate for those who have lived with the implantation for 18 months.

Unless a facility was involved in a clinical trial of one of the pumps now being tested, they could not get reimbursed without Joint Commission certification.

The number of hospitals nationally seeking destination VAD certification is growing rapidly, says Caroline Isbey, associate director for the commission's disease specific certification.

So far, most hospitals receiving that also have the capability of performing heart transplants. But more hospitals that are not transplant centers are applying for certification as well. "We have eight applications submitted this year, which will bring us close to 80 by the end of the year or the first quarter of next year," Isbey says.

The commission requires certification of destination therapy procedures because it needs to verify that a facility's cardiac surgeon, who will perform the procedure, has enough experience implanting VADS; that the hospital keeps the appropriate registry; and maintains sufficient program quality reviews, she says.

So far, not many VADs have been implanted as destination devices. Jaeger-Jackson says the largest centers have only done about 40. But a decision by the U.S. Food and Drug Administration to approve a newer device, also by Thoratec called HeartMate II, is expected by year's end, Jaeger-Jackson says.

If and when it is approved, more patients can be implanted with the newer device, she says.

That's because the current destination pumps, HeartMate XVEs, are shaped like a hockey puck—about three to four inches in diameter, and weigh about three to five pounds, and aren't appropriate for smaller-sized individuals.

In contrast, the HeartMate II is much smaller, about the size of a yogurt cup. It weighs less, and may be more durable because it has fewer touching parts, Jaeger-Jackson says. According to Sutter Transplant Services VAD Coordinator Sherry Martin, the HeartMate II could last five to 10 years.

In San Diego, Sharp Memorial Hospital (http://www.sharp.com/) is the only hospital south of Los Angeles to implant destination heart pumps and was among the original investigating centers for first HeartMate XVE, says Suzanne Chillcott, who leads the mechanical circulatory support team.

The hospital has now done at least 35 implants, and has sent people "home to get on with their lives, instead of home to die." In some cases, she says, patients have done so well, their diseases and organ failure issues have resolved and they're now well enough to be put on a transplant list for a real heart.

"This is definitely a very big growth area for hospitals," Chillcott says. "I believe there will be many more centers wanting to get involved in doing these."
According to the American Heart Association, an estimated 5 million Americans have congestive heart failure and 250,000 people in the U.S. die from it a year. More than a half a million new cases are diagnosed each year. The five-year average mortality rate is 50%.

Incident rates mortality and hospitalizations related to heart failure continue to rise. The AHA estimates that 34.8 billion was spent in direct and indirect costs on heart failure last year.