MCV brings Freedom to transplant patients

Currently when patients who need a heart transplant are fitted with an artificial heart (a replacement of the lower two chambers of the heart), they are forced to reside in the hospital for months. Cardiologists at VCU’s Pauley Heart Center, along with SynCardia Systems, Inc., are looking to change that.

Recently, SynCardia has developed an alternative to its original artificial heart power source, Big Blue. The alternative is a small device known as Freedom, which will enable patients with artificial hearts to wait for a transplant from their home.

Freedom is something that Clive M. Baumgarten, Ph. D, a professor of physiology, biomedical engineering and cardiology at VCU, believes will help everyone involved in the transplant process.

“It’s an enormous benefit to patients because rather than staying in the hospital they can go home,” said Baumgarten.  “It’s still being experimented with but it is certainly cheaper for patients to stay home even with some sort of supportive care. Then they get to stay with their family and are less likely to get hospital infections. The doctor and patient are happy, and it costs less.”

VCU is one of as many as 30 centers that will run tests on and use Freedom, according to the VCU News Center.

The university has been involved in what is conversationally known as “Total Artificial Heart Project” for four years. The device reflects years of development, with all of the basic pump research taking place at the University of Arizona starting in the late ’90s, according to Michael Hess, M.D., director of the VCU Pauley Heart Center advanced heart failure transplantation program.

Freedom is under investigation in the U.S. and is not yet available to the public. VCU is currently planning a clinical trial that will involve 60 patients.

“Hopefully if this goes well it will be released by the FDA [Federal and Drug Administration] for general use in big heart programs,” said Hess.

Currently, patients with artificial hearts are hooked up to SynCardia’s older power source, Big Blue. This model weighs significantly more than the newer one, which limits patients.

“Patients are managed on a 400 pound console, so the patient has to stay in the hospital continuously until they receive a transplant,”  said Hess. “Freedom Driver takes the 400 pounds and reduces it to 12-13 pounds that can be worn in a backpack so that patients will be able to go home.”

Users of Freedom will be able to carry the machine around in a backpack or shoulder bag.

Hess is hoping that the device could get approval in as little time as two years, depending on how long the enrollment takes with the FDA.

VCU has been involved in heart research and performing transplants since the early ’70s. At that time the late Dr. Richard R. Lower came from Stanford University to VCU Medical Center and performed the first heart transplant in Virginia, the second heart transplant in the U.S., and the 16th worldwide. Lower was well-known for his findings with his partner, Norman Shumway, M.D., that involved researching the transplantation of hearts by performing the procedure on canines. Lower worked at the university’s medical campus for almost 20 years, where he continued his research and contributed greatly to the cardiology program, according to the VCU News Center.

VCU does not yet have the Freedom Device as it is still undergoing preliminary tests.