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FDA Expands Use of Heart Valves
The FDA has approved an expanded indication for the Sapien XT and Sapien 3 transcatheter heart valves (Edwards Lifesciences) for patients with aortic valve stenosis who are at intermediate risk for death or complications associated with open-heart surgery. These devices were previously approved for use only in patients at high or greater risk for death or complications during surgery.
Aortic valve stenosis increases with age as the aortic valve becomes narrow, causing the heart to work harder to pump enough blood through a smaller opening. The disorder occurs in approximately 3% of Americans older than 75 years of age and can cause fainting, chest pain, heart failure, arrhythmias, cardiac arrest, or death. Patients with severe aortic valve stenosis generally need to have a heart valve replacement to improve blood flow through their aortic valve.
Traditionally, open-heart surgery has been the gold standard for aortic valve replacement in intermediate-risk patients, but it involves a larger incision and longer recovery time than does the minimally invasive procedure used to insert the transcatheter heart valve. Approximately one-third of patients referred for open-heart surgery for aortic valve replacement fall into the intermediate risk category, which is defined as having a greater than 3% risk of dying within 30 days after surgery.
In a clinical study, 1,011 aortic stenosis patients at intermediate risk for surgical complications were randomly selected to have a transcatheter aortic valve replacement procedure using the Sapien XT valve, and 1,021 were randomly selected to have a traditional aortic valve replacement during open-heart surgery using a surgical tissue valve. In a second study, 1,078 intermediate-risk patients were implanted with the Sapien 3 valve, and outcomes in these patients were compared with those of the same group of 1,021 surgical control patients in the first study. The two studies demonstrated a “reasonable assurance” of safety and efficacy of the Sapien XT and Sapien 3 devices in intermediate-risk patients, according to the manufacturer.
Patients who receive either the Sapien XT or the Sapien 3 valve face a potential risk of serious complications from the device or implantation procedure, such as death, stroke, acute kidney injury, heart attack, bleeding, and the need for a permanent pacemaker. The devices are contraindicated for patients who cannot tolerate blood-thinning medication. They are also contraindicated for those who are being treated for a bacterial or other infection.
As part of the approval of these devices, the FDA is requiring the manufacturer to conduct a post-approval study to follow the patients treated with either device in the first and second clinical studies for 10 years to further monitor safety and effectiveness.
Source: PR Newswire; August 18, 2016.