Henry Ford Hospital is First to Implant New Aortic Valve Replacement

September 18, 2013

FOR IMMEDIATE RELEASE

DETROIT – Heart valve replacement is a common procedure in the U.S., and performing the procedure through a catheter is a new and growing procedure. However, once placed, the new valve can’t be moved if there is a problem, such as blood leakage.

Henry Ford Hospital is the first in the U.S. to implant an artificial aortic heart valve delivered via a catheter that can be moved before it is permanently implanted to achieve optimal results, as part of a new investigational study.

“It is a major advance to be able to reposition a new heart valve when working through a catheter,” says William O’Neill, M.D., medical director of the Center for Structural Heart Disease at Henry Ford Hospital. “This device is also able to be delivered through narrower blood vessels, which will allow us to help more patients.

“Earlier versions of replacement heart valves cannot be repositioned once they have been implanted,” says Dr. O’Neill. “With the new valve, if there is a problem with placement, if it’s not precisely in place, we can now make that adjustment for a perfect fit.”

According to the American Heart Association, about five million Americans are diagnosed annually with heart valve disease, and nearly 1.5 million have aortic stenosis, a narrowing or hardening of the aortic valve caused by calcium build-up.

Aortic stenosis can cause severe shortness of breath, extreme fatigue, chest pain and fainting. Many people have difficulty walking for daily activities.

Seventy-seven-year old Martha Alexander of Livonia was a three-time cancer survivor, but she felt tired all the time, due to aortic stenosis. She was too frail for open-heart surgery, but a good candidate for the new replacement heart valve.

Nearly 290,000 elderly patients with severe aortic stenosis, or narrowing of the aortic heart valve, are candidates for transcatheter aortic valve replacement (TAVR). And approximately 27,000 patients become eligible for the procedure every year, according to a recent study in the Journal of the American College of Cardiology.

TAVR is a minimally invasive procedure for patients with severe narrowing of the aortic heart valve who cannot undergo open-heart surgery. Before the availability of this life-saving technique, these patients had few treatment options.

During the procedure, doctors thread a catheter with the replacement valve through a blood vessel in the leg to the heart’s failing aortic valve, and replace it with the new artificial valve.

Unlike previous metal-frame TAVR devices, the new Direct Flow Medical Transcatheter Aortic Valve System being studied uses a polymer frame, which is expanded using pressurized saline and contrast dye for placement, assessment and unlimited repositioning. Once optimally positioned, the saline/dye solution is replaced with a quick-curing polymer that solidifies and holds the valve in place. A conformable-ring valve creates a tight seal, virtually eliminating the risk of blood leakage. The valve can be repositioned or retrieved until the polymer has been added.

Only six hospitals in the U.S. are participating in the study of the new device, which is not yet approved for use in the U.S. outside of this clinical trial.

Alexander, grandmother of 11 and great-grandmother of one, is looking forward to returning to crocheting and needlework. Her doctors are monitoring the extent to which her energy levels return.