FDA Expands Use for Transcatheter Heart Valve

The US Food and Drug Administration (FDA) has approved an expanded indication for the Sapien 3 Transcatheter Heart Valve (THV).

The approval is for patients with symptomatic heart disease due to failure of a previously placed bioprosthetic aortic or mitral valve whose risk of death or severe complications from repeat surgery is high or greater, according to an FDA statement.

“For the first time, a regulatory agency is approving a transcatheter heart valve as a valve-in-valve treatment when bioprosthetic mitral or aortic valves fail in patients who are at high or greater risk of complications from repeat surgery,” said Bram Zuckerman, MD, director of cardiovascular devices at the FDA’s Center for Devices and Radiological Health. “This new approval offers US patients with failing surgical bioprosthetic aortic or mitral valves a less-invasive treatment option.”

According to the statement, bioprosthetic aortic or mitral valves can fail over time for three reasons: stenosis — when the valve narrows and causes the heart to work harder to pump blood; regurgitation – when the valve doesn’t completely close and leaks blood backwards; or a combination of both of these conditions.

The new approval marks a milestone improvement in care, because current treatments normally require open heart surgery, which causes high or greater risk of complications in many patients.

The Sapien 3 THV was originally approved by the FDA for transcatheter aortic valve replacement (TAVR) as an alternative option to surgical aortic valve replacement for patients with native aortic stenosis whose risk for death or severe complications from surgery is high or greater. Its use was expanded last year to include patients who are at intermediate surgical risk for death or complications.

Today’s approval is an expanded use of the Sapien 3 THV as a valve-in-valve treatment. Valve-in-valve procedures offer an alternative to repeat surgery, since the replacement valve is inserted inside the failing surgical bioprosthetic valve through a patient’s blood vessel or a small cut in a patient’s chest.

To justify the current expansion, the FDA reviewed data from the Transcatheter Valve Therapy Registry that included 314 patients who had undergone aortic valve-in-valve procedures and 311 patients who had undergone mitral valve-in-valve procedures.

More than 85% of patients who underwent aortic or mitral valve-in-valve procedures experienced clinically meaningful improvement in their heart failure symptoms 30 days after the procedure.

The Sapien 3 THV should not be used in patients who cannot tolerate medications that thin the blood or prevent blood clots from forming or have an active infection in the heart or elsewhere.

Patients who receive the Sapien 3 THV face potential serious complications from the device or implantation procedure, such as death, stroke, respiratory failure, heart failure, kidney failure and bleeding.