The U.S. Food and Drug Administration (FDA) recently approved expanding the use of Sapien 3 Transcatheter Heart Valve (THV) 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.

As a part of this approval, this FDA evaluated data from the STS/ACC TVT Registry, a partnership of the American College of Cardiology and the Society of Thoracic Surgeons. The registry collects clinical data on the safety and effectiveness of transcatheter valve replacement procedures performed in a real-world setting.

A bioprosthetic aortic or mitral valve may fail over time due to stenosis, regurgitation or a combination of both. Treatment would normally require repeat open heart surgery, which causes a greater risk of complications for certain patients. 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.

The FDA originally approved the Sapien 3 THV for transcatheter aortic valve replacement 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. In 2016, the FDA approved furthering the expansion to include patients who are at intermediate surgical risk for death or complications. The Sapien 3 THV is the first THV device approved for replacement of failed bioprosthetic aortic or mitral valves.

STS/ACC TVT Registry data showed that more than 85 percent 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, as shown by their New York Heart Association Classifications. In both aortic and mitral valve-in-valve patients, the observed mortality rates were substantially lower than the expected mortality rate for repeat surgery.

As part of the approval, the manufacturer will participate as a stakeholder of the STS/ACC TVT Registry to ensure FDA surveillance for the device over the next five years. Read the full FDA announcement here. 

Keywords: Aortic Valve, Aortic Valve Stenosis, Heart Valve Prosthesis, Heart, Artificial, Mitral Valve, Registries, Transcatheter Aortic Valve Replacement, United States Food and Drug Administration

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