There is a potential risk of early structural valve deterioration with the Abbott Trifecta valve and Trifecta valve with glide technology (Trifecta GT), the US Food and Drug Administration (FDA) says in a letter to healthcare professionals posted on its website.
Evidence in the literature suggests a higher cumulative incidence of early structural valve deterioration (SVD) and a lower freedom from reintervention due to SVD with the Trifecta valves, compared with other commercially available bovine pericardial valves, the FDA says.
The Trifecta and Trifecta GT valves are heart valve replacement devices intended to treat diseased, damaged, or malfunctioning native or prosthetic aortic heart valves, the letter notes. The first-generation Trifecta valve was approved in 2011 but is no longer marketed in the United States. The Trifecta GT valve was approved in 2016.
Medical device reports (MDRs) received by the FDA describe early SVD with Trifecta valves, with a peak time to SVD of 3 to 4 years post-implant. “Reported outcomes include surgical valve explant/replacement, transcatheter valve-in-valve intervention, and in some cases death,” the FDA notes.
In a letter to customers, Abbott says a “complaint analysis has shown that most cases of early SVD which occur within 5 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.”
The FDA recommends that healthcare providers take the following actions:
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Be aware of the potential risk of early SVD with Trifecta valves, and current patient management considerations, as communicated by Abbott.
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Discuss the risks and benefits of all available aortic valve treatment options with patients and caregivers as part of shared clinical decision-making prior to surgery.
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Read and carefully follow the Instructions for Use (IFU) when implanting a Trifecta GT valve.
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Monitor patients who have undergone implantation with Trifecta valves for signs and symptoms of potential SVD.
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Instruct patients to seek medical attention with new onset of symptoms such as shortness of breath or fatigue.
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Ensure lifelong follow-up visits, conducted at least yearly, including transthoracic echocardiogram (TTE) assessment of the valve beginning 1-year post-implant.
The FDA is working with Abbott to further evaluate the issue and develop additional patient management strategies, if needed. The FDA says it will continue to monitor the literature and reports of adverse events related to the issue.
Clinicians are encouraged to report any adverse events or quality problems with the Trifecta valves to their local Abbott representative or the customer service department at 1-800-544-1664.
Healthcare professionals can also report adverse reactions or quality problems they experience using these devices to the FDA’s MedWatch program.
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