FDA: Early structural aortic valve deterioration may be issue with surgical valve
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The FDA has issued a letter to health care providers about potential risk for early structural valve deterioration with Abbott’s surgical aortic heart valves featuring externally mounted leaflets on the valve frame.
Information from published literature indicated increased early structural valve deterioration of the valves (Trifecta and Trifecta GT) reduced freedom from reintervention compared with other commercially available surgical bioprosthetic valves, according to a press release from the agency.
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The FDA issued the following recommendations to health care providers:
- Be aware of the potential risk of early structural valve deterioration with the valves, and any patient management considerations communicated by Abbott.
- Prior to surgery, discuss risks and benefits of all available aortic valve treatment options with patients and caregivers as part of a shared clinical decision-making strategy.
- Read and carefully follow the instructions for use when implanting the valves.
- Monitor patients for signs and symptoms of potential structural valve deterioration.
- Instruct patients to seek medical attention with new symptoms such as shortness of breath or fatigue.
- Ensure lifelong follow-up visits, at least yearly, including transthoracic echocardiogram assessment of the valve beginning 1 year after implantation.
- Report any valve-related adverse events to the FDA.
The first-generation valve was first approved in 2011 and is no longer marketed in the U.S. The next-generation valve (Trifecta GT) was approved in 2016, according to the release.
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