FDA Expands Indication for Sapien 3 Transcatheter Heart Valve

The US Food and Drug Administration recently expanded the approval of Sapien 3 Transcatheter Heart Valve (THV) to include valve-in-valve treatment of heart disease in patients whose bioprosthetic aortic mitral valve failed and are at increased risk of death or severe complications if they undergo a repeat surgery.

Sapien 3 THV was originally approved for transcatheter aortic valve replacement (TAVR) as an alternative option to surgical aortic valve replacement for patients with native aortic stenosis with a significantly increased risk of death or severe complications from surgery. The device indication was expanded in 2016 to include patients who were at an intermediate surgical risk for death or complications.
______________________________________________________________________________________________________________________________________________________________

RELATED CONTENT
Study: Oral Device Therapy Reduces OSA Severity but Has No Effect on CVD Risk Factors
Coronary Artery Calcium in Midlife Increases Risk for Heart Disease
______________________________________________________________________________________________________________________________________________________________

The efficacy and safety of Sapien 3 THV was based on data from the Transcatheter Valve Therapy Registry that included 314 patients who underwent aortic valve-in-valve procedures and 311 patients who underwent mitral valve-in-valve procedures. Over 85% of patients who received aortic or mitral valve-in-valve procedures experienced a clinically meaningful improvement in heart failure symptoms 30 days after the procedure, and had substantially lower mortality rates than the expected mortality rates for repeat surgery.

Valve-in-valve treatment with Sapien 3 THV should not be performed in patients with an active infection in the heart or elsewhere, and should not be performed in patients who cannot take blood thinners or medications that prevent blood clots.

Potentially serious complications that can occur after implantation include death, stroke, respiratory failures, heart failure, kidney failure, and bleeding.

—Melissa Weiss

Reference:

FDA expands use of Sapien 3 artificial heart valve for high-risk patients [press release]. FDA. Published June 5, 2017. https://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm561924.htm?source=govdelivery&utm_medium=email&utm_source=govdelivery. Accessed June 6, 2017.