Transcatheter Aortic Heart Valve Replacement
University of Wisconsin Hospital and Clinics was selected as one of the first sites in the country to offer a new heart valve replacement therapy for patients too sick to undergo traditional open heart surgery to correct severe aortic stenosis.
The SAPIEN Transcatheter Heart Valve, manufactured by Edwards Lifesciences, was approved in November 2011 by the U.S. Food and Drug Administration (FDA). The device is designed to replace a patient's diseased native aortic valve without the need for open heart surgery or the use of a heart-lung machine. It is the first device for transcatheter aortic valve replacement therapy (TAVR) to receive FDA approval and the only device to have approval to date.
Why is transcatheter heart valve replacement important?
The aortic valve directs blood from the left ventricle into the aorta (the large vessel that carries blood to the rest of the body), and when the valve does not function properly, the heart has to work harder to pump the blood. This condition, known as aortic stenosis, causes extra strain that weakens the heart and puts patients at risk for heart failure and irregular heart rhythms. Patients may have symptoms such as dizziness, syncope, fatigue, chest pain and intolerance to exercise that get progressively worse.
Learn more: Aortic valve stenosis
The SAPIEN Transcatheter Heart Valve is approved for the treatment of adult patients with severe symptomatic native aortic valve stenosis who have been determined by a cardiac surgeon to be inoperable for open aortic valve replacement, and in whom existing conditions would not preclude the expected benefit from correction of the aortic stenosis.
During the procedure, the valve is inserted via the femoral artery in the thigh on a catheter that is pushed through the blood vessels until it reaches the diseased aortic valve. A balloon on the end of the catheter expands the new valve to the correct size so it will remain in position. This procedure is done without stopping the heart and there is no need for cardiopulmonary bypass.
Transcatheter aortic valve replacement is a significant procedure involving general anesthesia, and placement of the valve is associated with specific contraindications as well as serious adverse effects, including risks of death, stroke, damage to the artery used for insertion of the valve, major bleeding and other life-threatening and serious events. In addition, the longevity of the valve's function is not yet known.
Patients are encouraged to contact their physician for more information about this procedure.
- Leon MB, Smith CR, Mack M, et al. Transcatheter aortic-valve implantation for aortic stenosis in patients who cannot undergo surgery. N Engl J Med. 2010;363(17):1597-1607.
- Ye J, Cheung A, Lichtenstein SV, et al. Transapical transcatheter aortic valve implantation: follow-up to 3 years. J Thorac Cardiovasc Surg 2010; 139:1107-1113.
- U.S. Food and Drug Administration (November 2, 2011). FDA approves first artificial aortic heart valve placed without open-heart surgery [press release]. Retrieved from http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm278348.htm
- Food and Drug Administration website