On February 27, 2023, the U.S. Food and Drug Administration (FDA) issued a warning letter to medical professionals concerning the potential risk of early structural valve deterioration (SVD) with Abbott Trifecta valves. The affected valves include Abbott’s standard Trifecta valves and its Trifecta valves with Glide Technology (GT). The issue involves a higher accumulative incidence of early structural valve deterioration (SVD) for Trifecta valves compared to other surgical bioprosthetic valves.
The FDA stated in the warning letter to healthcare providers that it received adverse incident reports describing early structural valve deterioration. The FDA is currently working with Abbott to assess all available information. The FDA is encouraging patients and doctors to report all adverse events connected with the affected Trifecta valves. The FDA also stated that fast reporting of any adverse events helps the FDA determine and better comprehend the safety risks associated with surgical bioprosthetic valves.
To minimize the risk of early structural valve deterioration (SVD) with Trifecta valves, healthcare providers should be aware of current patient management considerations, as communicated by Abbott. When discussing treatment options with patients and their caregivers, all available aortic valve treatment options should be reviewed to make a shared clinical decision before surgery. If a Trifecta GT valve is chosen, the Instructions for Use (IFU) should be read and carefully followed during implantation.
After implantation, patients who have received a Trifecta valve should be monitored for signs and symptoms of potential SVD, and if new symptoms such as shortness of breath or fatigue occur, patients should be instructed to seek medical attention. Lifelong follow-up visits should be scheduled at least yearly, including a transthoracic echocardiogram (TTE) assessment of the valve starting one-year post-implantation. Any adverse events related to Trifecta valves should be reported to the FDA by referring to the Reporting Problems to the FDA section below.
The affected Abbott Trifecta and Trifecta GT valves are replacement heart valve devices that treat damaged, diseased, or malfunctioning prosthetic or native aortic heart valves. Abbott’s first-generation Trifecta valve was first approved in 2011, but the medical device is no longer being marketed in the United States. The FDA approved Abbott’s Trifecta GT valve in 2016.
The FDA routinely monitors the safety and effectiveness of medical devices by evaluating adverse event reports and published literature. Published studies have compared the durability of Trifecta valves to other commercially available bovine pericardial valves at various time points post-implant. These studies have indicated a higher incidence of early SVD and lower freedom from reintervention due to SVD associated with Trifecta valves.
The published literature includes results for both Trifecta and Trifecta GT valves, and patient management considerations provided by Abbott apply to both models. Healthcare providers should be aware of these findings when considering Trifecta valves for their patients and should take appropriate measures to minimize the risk of SVD.
The FDA has received medical device reports (MDRs) that detail instances of early structural valve deterioration (SVD) with Trifecta valves. These reports have indicated that the peak time for SVD occurs three to four years post-implant and that outcomes have included surgical valve explant/replacement, transcatheter valve-in-valve intervention, and, in some cases, death.
While the FDA recognizes the limitations of MDR data, including the inability to determine incidence from passive surveillance reporting systems, it is one source of information used by the agency to monitor the safety of medical devices. Healthcare providers should take note of these reports and implement appropriate measures to monitor patients who have received Trifecta valves for signs and symptoms of potential SVD. If any adverse events occur, they should be promptly reported to the FDA.
The FDA is collaborating with the manufacturer to thoroughly evaluate the issue related to early SVD with Trifecta valves and will develop additional patient management strategies, if necessary. The FDA will continue to monitor literature and reports of adverse events related to Trifecta valves to ensure patient safety. The FDA will promptly inform the public if any significant new information or recommendations become available. Healthcare providers should stay informed about any updates and adjust their patient management strategies accordingly.
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