In an industry first, the FDA approved an expanded indication for transcatheter heart valves for patients with aortic valve stenosis at intermediate risk for death or complications from open-heart surgery.
Previously, transcatheter heart valves were only approved for patients at high or greater risk for death or complications from surgery. Roughly one-third of patients referred for open-heart surgery for aortic valve replacement fall into the intermediate-risk category.
Patients with severe aortic valve stenosis generally need heart valve replacement to improve blood flow. 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 the minimally invasive procedure used to insert the transcatheter heart valve.
Manufactured by Edwards Lifesciences, the Sapien 3 transcatheter heart valve consists of a catheter-based artificial aortic heart valve and accessories used to implant the valve via the femoral artery. The valve is attached to a balloon-expandable, cobalt-chromium frame, and is pushed through the blood vessels until it reaches the diseased aortic valve, which is expanded by the balloon and is anchored to the diseased valve. Once the new valve is in place, it opens and closes properly, allowing the blood to flow in the correct direction.
The Edwards Sapien XT transcatheter heart valve consists of a catheter-based artificial aortic heart valve and accessories much like the Sapien 3, and it comes in three sizes: 23 mm, 26 mm, and 29 mm.
The approval was supported by clinical studies in 1,021 intermediate-risk patients implanted with the Sapien XT heart valve, and in 1,078 intermediate risk patients implanted with the Sapien 3 valve. The two studies demonstrated a reasonable assurance of safety and effectiveness of both transcatheter heart valves in intermediate-risk patients.
As part of the approval, Edwards is required to conduct a post-approval study to follow patients treated with either device for 10 years to monitor safety and effectiveness.
The devices are contraindicated in patients who can’t tolerate blood thinning medication as well as patients being treated for a bacterial or other infection.
The Sapien XT was also approved in 2015 to treat patients who had previously received tissue aortic valves that failed. — Tamra Sami