FDA Approves Heart Valve Device
Written by Faith Anderson on November 4, 2011
Senile Aortic Valve Stenosis
Senile aortic valve stenosis is a progressive, age-related disease caused by calcium deposits on the aortic valve, which cause the valve to narrow. A smaller valve opening means the heart must work harder to pump enough blood through the valve, which eventually results in a weakened heart. This can lead to serious complications like heart failure, chest pain, fainting, cardiac arrest or irregular heart rhythms. Once senile aortic valve stenosis symptoms begin, more than half of patients die within two years. In most cases, open-heart surgery is the preferred method of treatment, in order to replace the damaged valve and restore normal blood flow. Unfortunately, this procedure carries too many risks for some patients.
“Surgery to replace the aortic valve is an effective treatment for severe senile aortic valve stenosis. The Sapien THV 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 Jeffrey Shuren, M.D., director of the FDA’s Center for Devices and Radiological Health. “The agency remains committed to working with companies who are developing breakthrough treatments that will have a significant impact on patient care in the U.S.”
Sapien THV Risk Profile
The FDA’s approval of the Sapien THV is based on a study involving 365 patients with senile aortic stenosis who were not eligible for open-heart surgery. Half of the patients received the Sapien valve and half received an alternative treatment that also did not require open-heart surgery. According to the study, patients who received the Sapien valve were more likely to survive one year after surgery, compared to patients who did not receive the implant. After one year, 69% of the Sapien patients were alive, compared to 50% of the patients who received an alternative treatment. Unfortunately, patients who received the Sapien valve also experienced two and a half times more strokes and eight times as many vascular and bleeding complications than the other group.
The most common serious and potentially life-threatening side effects in patients receiving the Sapien valve include stroke, death, perforation of the blood vessels, ventricle or valvular structures, significant bleeding, damage to the conduction system in the heart, and leaks around the new valve. According to the FDA, the Sapien THV is approved for senile aortic stenosis patients who are not eligible for open-heart surgery to replace a damaged aortic valve. The Sapien valve is not approved for patients who can be treated with open-heart surgery, and is not recommended in patients who have congenital heart valve anomalies, have masses or an infection in their hearts, or cannot tolerate anticoagulation/antiplatelet therapy. The product label recommends that a heart surgeon be involved in determining if the Sapien valve procedure is an appropriate treatment for the patient.