• FDA Approves Less Invasive Treatment for High-Risk Surgery Patients With Severe Aortic Valve Stenosis

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    On Nov. 2, 2011, the Food and Drug Administration (FDA) approved a new treatment for patients with severe aortic valve stenosis who are not good candidates for surgery. Surgery continues to be the most successful way to treat this disease. However, because they are older or have other medical problems, some patients face a greater than 50 percent chance of dying from open-heart surgery. Now, with the FDA’s approval of the Edwards SAPIEN transcatheter heart valve, many of these patients can have transcatheter aortic valve implantation (TAVI), a procedure to replace the old valve. This new procedure replaces the diseased aortic valve through a tube that is placed in the patient’s leg, or through an incision in the chest that is much smaller than traditional surgery.

    The FDA’s decision to approve SAPIEN is based on the results of findings from the PARTNER clinical trial. Patients in the clinical trial who received TAVI were significantly less likely to die within the first year of the procedure. They experienced more improvement in their symptoms than the group who received other treatments, including balloon valvuloplasty, a procedure that stretches open the valve but does not replace it. Unfortunately, SAPIEN recipients also had more strokes and other vascular complications, such as bleeding.

    If you have been told that you have aortic stenosis but are too sick for surgery, you may be interested in considering this procedure. If you do consider this procedure, be sure to discuss both the benefits and the complications with your doctor. You can also click here for other questions to print, add to, and take with you to your next appointment with your doctor.

    If you are a candidate for the procedure and you decide to go forward, your cardiologist will help you coordinate your care. Talk with him or her about finding a team that includes not only your primary and interventional cardiologists, but also a heart surgeon. TAVI is a complex procedure. Make sure you have a team of cardiologists who can work together and who have performed the procedure many times at a medical center with the necessary resources and facilities.  

    Other devices similar to SAPIEN are in development and may become available in the future.

    Please, don't forget to read over or take this list of Questions to Ask Your Doctor about Percutaneous Aortic Valve Replacement when you speak with your physician. You can print it here. (PDF version)

    SecondsCount offers more information about this and other treatment options for aortic valve stenosis.