FDA Approves New Treatment for Valve Replacement: Gives Hope to Patients Once Considered Inoperable
There is some exciting news for those suffering from heart valve disease. In November 2011, the U.S. Food and Drug Administration announced the approval of a first-of-its-kind heart valve that can be implanted without open-heart surgery.
Called the Sapien valve, the UVA Cardiac Valve Center helped pioneer this major advancement, giving hope to thousands suffering from aortic stenosis.
What is Aortic Stenosis?
Over 300,000 Americans suffer from this condition where the aortic valve narrows, forcing the heart to work harder to pump blood throughout the body. It can cause chest pain, fatigue and shortness of breath, making even mundane tasks difficult.
Aging, the Main Culprit
While birth defects, infections or conditions such as heart disease may cause valve problems, Scott Lim, MD , says the most common cause is aging. “Every moment, our heart is beating and that causes wear and tear on the heart,” explains Lim, co-director of the UVA Cardiac Valve Center. “For most of us, that’s just fine. But with the aging of the population, as people get into their 70s, 80s and 90s, we’re seeing this as much more common because people are living longer than they used to.”
Every year, about 50,000 people undergo open-heart surgery to replace a failing aortic valve, but thousands are turned away because they are considered too old or ill to survive major surgery. Now, with FDA approval of the Sapien valve, there is a less-invasive option for those who are not eligible for open-heart surgery.
During the procedure, the Sapien valve is navigated through a blood vessel to the heart using a catheter (thin, hollow tube). This means only a small incision in the leg is needed. The new valve pushes aside the diseased aortic valve and restores blood flow from the heart to the body. “Patients recover in days, not weeks and often report that they have more energy to do the things they enjoy,” says Lim.
The Future of Valve Disease Treatment
This “transcatheter” approach to aortic valve replacement using the Sapien valve is just one of several procedures to treat faulty valves . UVA is also performing percutaneous mitral valve repair (through a small incision in the skin) as well as pulmonary valve implantation. These investigational techniques are still relatively new, Lim says, so data doesn’t exist to help physicians predict how long the replacement valves will last.
“UVA is one of the few sites in the country offering these alternative options, and our clinical trials show that they are remarkable in how safe they are compared to standard surgery,” says Lim. “For some, especially those who are not surgical candidates, it is the best way to go.”
The UVA Cardiac Valve Center has Virginia’s most experienced team in providing the latest treatment options and research for valve disease. For more information or to make an appointment, visit uvahealth.com/valve or call 434.243.1146