The U.S. Food and Drug Administration (FDA) has approved 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.

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."

"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 ACC Surgeons' Council member Joseph Cleveland, MD, FACC. "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."

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 that 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.

Keywords: ACC Advocacy, Transcatheter Aortic Valve Replacement, Aortic Valve, Aortic Valve Stenosis, Heart Valve Prosthesis, Aortic Aneurysm, Coronary Artery Disease, National Cardiovascular Data Registries

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