Letter Issued Concerning Early Structural Valve Deterioration of Abbott Trifecta Valves

The U.S. Food and Drug Administration informed healthcare providers about a potential risk of early structural valve deterioration (SVD) with Abbott Labs’ Trifecta valves, including both the Trifecta valve and Trifecta valve with Glide technology (Trifecta GT), which has leaflets externally mounted to the valve frame.
 
The valves are valve replacement devices designed to treat diseased, damaged, or malfunctioning native or prosthetic aortic heart valves. The first-generation valve was approved in 2011 and is no longer marketed in the U.S. The Trifecta GT valve was approved in 2016.
 
According to the FDA, information from published literature suggests greater cumulative incidence of early (five years or less) SVD for Trifecta valves compared to other available surgical bioprosthetic valves. The literature includes comparison of durability for Trifecta valves compared to other available bovine pericardial valves across different timelines post-implantation.
 
Outcomes suggested a greater cumulative early SVD incidence and lower freedom from reintervention due to SVD. The peak time to SVD was three to four years following implantation, with reported outcomes of surgical valve/explant replacement, transcatheter valve-in-valve intervention, and in some cases, death.
 
FDA is working with Abbott to evaluate information from all available sources concerning this issue. The agency and Abbott urged awareness of the potential risk of early SVD, discussing the risks and benefits of all available aortic valve treatment options, and monitoring patients implanted with Trifecta valves for potential SVD symptoms.
 
FDA is also working with Abbott to further evaluate the issue and develop additional patient management strategies, if required.