The FDA is informing health care providers about the potential risk of early structural valve deterioration (SVD) with Abbott Trifecta valves, including the Trifecta Valve and the Trifecta Valve with Glide Technology (Trifecta GT), which feature leaflets externally mounted to the valve frame.
Information from published literature suggests a higher cumulative incidence of early (five years or less) SVD for Trifecta valves compared to other commercially available surgical bioprosthetic valves. The FDA said it is working with the manufacturer to evaluate information from all available sources on this issue.
The FDA is encouraging health care providers to report adverse events related to Trifecta valves to the FDA. Prompt reporting of adverse events can help the FDA identify and better understand the risks associated with medical devices.
Abbott said in a separate letter that its complaint analysis has shown that most cases of early SVD which occur within five years post-implant are characterized as a non-calcific leaflet tear, while most cases of late SVD which occur beyond 5 years post-implant are characterized as a fibrous-calcific SVD.
"In summary, a recent literature review of the Trifecta valve indicates a higher early and midterm cumulative incidence of SVD relative to comparator bovine pericardial valves. While the data primarily reflects the 1st generation Trifecta valve, the 4-year clinical trial data for the Trifecta GT valve suggests that its performance and durability is comparable to the 1st generation Trifecta valve, such that the following patient management considerations apply to the entire Trifecta family of valves," the company wrote.
The FDA and Abbott are advising health care providers to be aware of the potential risk of early SVD with Trifecta valves, and to discuss the risks and benefits of all available aortic valve treatment options with patients and their caregivers.
