The Food and Drug Administration (FDA) has issued a safety alert regarding 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.

The Trifecta and Trifecta GT valves are heart valve replacement devices designed to treat diseased, damaged, or malfunctioning native or prosthetic aortic heart valves. According to published literature, Trifecta valves appear to be associated with have a higher cumulative incidence of early SVD (5 years or less) and lower freedom from reintervention due to SVD, compared with other commercially available surgical bioprosthetic valves.

Early SVD was also described in medical device reports submitted to the FDA. Peak time to SVD with Trifecta valves was reported to be 3 to 5 years post-implant. Outcomes related to these cases included surgical valve explant/replacement, transcatheter valve-in-valve intervention, and death.

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It is recommended that the risks and benefits of all available aortic valve treatment options be discussed with patients prior to surgery. Patients who have received implantation with Trifecta valves should be monitored for signs and symptoms of potential SVD. These patients should also receive lifelong follow-up visits, conducted at least yearly, with a transthoracic echocardiogram assessment beginning 1 year post-implant.

The FDA is evaluating the issue with Abbott and developing additional patient management plans. Health care providers are encouraged to report any adverse events or suspected adverse events with Abbott Trifecta valves to the FDA’s MedWatch program.

References

  1. Abbott Trifecta Valves: potential risk of early structural valve deterioration- letter to health care providers. US Food and Drug Administration. February 27, 2023. Accessed March 2, 2023. https://www.fda.gov/medical-devices/letters-health-care-providers/abbott-trifecta-valves-potential-risk-early-structural-valve-deterioration-letter-health-care.
  2. Important information regarding SVD in Trifecta family of valves. Abbott. February 27, 2023. Accessed March 2, 2023. https://www.structuralheart.abbott/fileadmin/pdf/FINAL_Abbott_Letter_US_Trifecta_Abbott_Website_signed.pdf.

This article originally appeared on MPR

Topics:

Cardiovascular Disease CHF and Arrhythmias Devices