FRIDAY, Aug. 16, 2019 (HealthDay News) -- The U.S. Food and Drug Administration announced today that certain transcatheter heart valves are now approved for use in patients with severe aortic valve stenosis who have a low risk for death or major complications during open-heart surgery.
Previously, the transcatheter valves, which include Sapien 3, Sapien 3 Ultra, CoreValve Evolut R, and CoreValve Evolut PRO, were indicated only for patients at intermediate or higher risk for death or major complications during open-heart surgery. According to the FDA, although open-heart surgery has been the standard of care for aortic valve replacement, inserting a transcatheter heart valve is less invasive and requires a smaller incision and shorter recovery time.
The approval of this new indication was based on data from two clinical studies. In one study, 503 and 497 patients with severe aortic valve stenosis at low risk for surgical complications were randomly selected to undergo aortic valve replacement with the Sapien 3 and traditional open-heart surgery, respectively. In the second study, 734 low-risk patients with severe aortic valve stenosis were randomly selected to undergo aortic valve replacement with the CoreValve Evolut R or CoreValve Evolut PRO and 734 patients were randomly selected to undergo traditional open-heart surgery. At an average 15- to 17-month follow-up, the results of the transcatheter heart valves were comparable to those of traditional open-heart surgery.
Serious complications reported with transcatheter heart valves included death, stroke, acute kidney injury, heart attack, bleeding, and need for a pacemaker. The FDA says transcatheter heart valves should not be used in patients who cannot take blood-thinning medications or who have a heart or other infection. The CoreValve Evolut R and CoreValve Evolut PRO devices are also contraindicated in patients with a titanium or nickel sensitivity.
The FDA is requiring the manufacturers of these devices to follow patients enrolled in the randomized studies for 10 years to monitor the safety, effectiveness, and long-term durability of the transcatheter aortic valves. Approval of the Sapien 3 and Sapien 3 Ultra was granted to Edwards Lifesciences LLC; approval of the CoreValve Evolut R and CoreValve Evolut PRO was granted to Medtronic CoreValve LLC.