FDA Approves New Artificial Heart Valve Studied Extensively in Utah at Intermountain Medical Center

SALT LAKE CITY – The U.S. Food and Drug Administration has approved the first artificial heart valve that can replace an aortic heart valve damaged by heart disease that does not require open-heart surgery.  Heart researchers and cardiac surgeons at the Heart Institute at Intermountain Medical Center played a key role in the approval of the breakthrough valve as the Utah hospital was one of only 25 centers in the country to participate in the devices pioneering clinical trial.

Brian Whisenant, MD, director of the structural heart program at the Heart Institute Intermountain Medical Center, and Kent Jones, MD, chairman of the department of cardiovascular thoracic surgery, led the pioneering clinical trials that led to the FDA's approval of the valve. Rose Felice from Price was the first patient in Utah to receive the valve at the Heart Institute at Intermountain Medical Center in 2009. Two years later she is still doing well.

"Surgery to replace the aortic valve is an effective treatment for severe aortic valve stenosis. The Sapien Transcatheter Heart Valve is an example of an innovative new device that will provide some people with this condition who can't undergo open heart surgery with the option of valve replacement," said Dr. Whisenant.

Aortic valve stenosis is a progressive, age-related disease caused by calcium deposits on the aortic valve that cause the valve to narrow. As the heart works harder to pump enough blood through the smaller valve opening, the heart eventually weakens, which can lead to problems such as fainting, chest pain, irregular heart rhythms or cardiac arrest. Once symptoms of aortic stenosis occur, more than half of patients die within two years.  

To restore normal blood flow, patients with severe aortic valve stenosis need open-heart surgery to replace the diseased valve. However, the procedure is too risky for some patients.

The valve is made of cow tissue and polyester supported with a stainless steel mesh frame. To replace the diseased valve, it is compressed into the end of a long, thin, tube-like device called a delivery catheter. The delivery catheter, which is slightly wider than a pencil, and the valve are inserted into the femoral artery through a small incision in the leg and threaded to the site of the diseased valve. The heart valve is then released from the delivery catheter and expanded with a balloon and is immediately functional.  

The FDA's approval of the Sapien THV is based on a study in 365 patients who were not eligible for open-heart surgery.  Intermountain Medical Center was the only center in the Intermountain West to participate in the study.  In the  trial, half of the patients received the Sapien valve. The other study patients received another treatment that did not require open-heart surgery.  One alternative procedure involved enlarging the aortic valve opening by stretching it with a balloon (balloon valvuloplasty).

Patients receiving the Sapien valve were more likely to survive one year after surgery. After a year, 69 percent of the Sapien patients were alive compared with 50 percent of those who received an alternative treatment.