Hot off the Press…The U.S. Food and Drug Administration (FDA) approves an expanded indication for several transcatheter heart valves (Sapien 3, Sapien 3 Ultra, CoreValve Evolut R and CoreValve Evolut PRO) to include patients with severe aortic valve stenosis at low surgical risk.
According to the FDA, the incidence of aortic valve stenosis increases with age. As the aortic valve opening narrows, the heart must work harder to pump blood to the body. Occurring in about 3% of Americans over age 75, severe aortic valve stenosis can cause fainting, chest pain, heart failure, irregular heart rhythms (arrhythmias), cardiac arrest or death. Patients with severe aortic valve stenosis generally need to undergo heart valve replacement to improve blood flow through their aortic valve.
Expanding the Use of TAVR
The FDA is the first medical products regulatory body in the world to expand the indication for transcatheter aortic valve replacement (TAVR) to this patient population. As part of the approval process, manufacturers are required to continue to follow patients enrolled in their randomized studies for 10 years to further monitor safety and effectiveness, including long-term valve durability. Additionally, manufacturers will also participate in the STS/ACC TVT Registry in order to provide the FDA with additional surveillance over a 10-year period.
According to the FDA, the transcatheter heart valves “should not be used in patients who cannot tolerate blood thinning medications or have an active infection in the heart or elsewhere. Additionally, the CoreValve Evolut R and CoreValve Evolut PRO devices should not be used in patients who have sensitivity to titanium or nickel,” notes the federal agency charged with protecting and promoting the public’s health.
“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, M.D., director of the Office of Cardiovascular Devices in the FDA’s Center for Devices and Radiological Health. “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 in both the premarket and postmarket settings to ensure patients have access to high-quality, safe, and effective medical devices,” he says.
“The treatment paradigm for aortic stenosis has evolved from a discussion about risk of surgery to one where anatomy really will dictate the choice between TAVR and SAVR,” says Joseph Cleveland, MD, FACC, ACC Surgeons’ Council member. “For most patients, the preferred treatment will be TAVR unless specific conditions like concomitant multivessel coronary artery disease, the presence of an aortic aneurysm, or aortic root anatomy which is not suitable for a TAVR exist. The FDA’s approval of TAVR now allows access for all patients with aortic stenosis to have greater treatment options with a lower risk of major complications. Clearly optimal treatment for patients will continue to include a heart team approach to assist patients in choosing the most appropriate therapy for treatment of their aortic stenosis,” he says.
Getting the Word Out
According to American College of Cardiology’s (ACC) August 16 statement, earlier this year, results of the landmark PARTNER 3 and EVOLUT trials presented at ACC.19 in New Orleans and simultaneously published in the New England Journal of Medicine showed outcomes after TAVR were superior or at least as good as those following surgical aortic valve replacement (SAVR) among patients with severe aortic stenosis at low surgical risk.
In June, CMS finalized revisions to the national coverage determination \hat governs coverage of TAVR. That coverage was written to evolve with future indications changes, so TAVR is covered when an FDA-approved complete aortic valve and implantation system is used for that system’s FDA-approved indication.
As part of the approval of these devices, the FDA is requiring each manufacturer to continue to follow patients enrolled in their randomized studies for 10 years to further monitor transcatheter aortic valve safety and effectiveness, including the long-term valve durability. The manufacturers will also participate in the Society of Thoracic Surgeons/American College of Cardiology Transcatheter Valve Therapy Registry to provide FDA with additional surveillance of these devices over a 10-year period.