In an eagerly anticipated move, the FDA expanded its indication for transcatheter aortic valve replacement (TAVR) to patients with severe aortic stenosis at low risk for surgery. The expansion, announced in August, includes Edwards Life-sciences’ Sapien 3 and Sapien 3 Ultra and Medtronic’s CoreValve Evolut R and CoreValve Evolut PRO heart valves, all of which previously had been limited to intermediate- and high-risk patients.

The FDA’s decision makes the U.S. the first country to open up the procedure to patients at low risk for death or major complications during open-heart surgery. 

“This new approval significantly expands the number of patients that can be treated with this less-invasive procedure for aortic valve replacement and follows a thorough review of data demonstrating these devices are safe and effective for this larger population,” said Bram Zuckerman, MD, director of the FDA’s Office of Cardiovascular Devices, in the FDA’s statement. “As the FDA assesses new medical technologies or expanded uses for previously approved products such as these, the agency remains committed to evaluating evidence from clinical trials and real-world clinical data both in the premarket and postmarket settings to ensure patients have access to high-quality, safe and effective medical devices.”

The FDA based its premarket approval of the valves on two clinical studies. In the first, 503 and 497 low-risk patients with severe aortic stenosis were randomized to TAVR with the Sapien 3 valve or to traditional open-heart surgery with a tissue valve, respectively (N Engl J Med 2019;380[18]:1695-1705). In the second, 734 low-risk patients assigned to TAVR with one of the Evolut valves were compared to 734 matched patients who underwent open-heart surgery (N Engl J Med 2019;380[18]:1706-15).

At an average of 15 to 17 months follow-up, the results of both studies suggested TAVR was just as successful as surgical valve replacement.

The FDA said it will require both valve manufacturers to continue following up with patients enrolled in the randomized studies for at least a decade, to “further monitor transcatheter aortic valve safety and effectiveness, including long-term valve durability.” The companies also will participate in the Society of Thoracic Surgeons/American College of Cardiology Transcatheter Valve Therapy Registry.