FDA Warns Doctors of Abbott Trifecta Valve Deterioration Risks

Federal health officials indicate that certain Abbott heart valve replacement devices may increase the risk that patients will require an early valve replacement surgery, or experience serious and potentially life-threatening health complications.

The U.S. Food and Drug Administration (FDA) issued an Abbott Trifecta valve replacement warning on February 27, alerting healthcare providers that the Trifecta Valve and the Trifecta Valve with Glide Technology (Trifecta GT) may deteriorate at a much faster rate when compared to other commercially available valves.

The Trifecta and Trifecta GT models are part of a class of medical devices known as surgical bioprosthetic valves, which are designed to treat individuals with diseased, damaged, or malfunctioning aortic heart valves. The aortic heart valve is one of four primary valves of the heart, which separates the lower left heart chamber and the body’s main artery.

While the first generation model of the Trifecta valve first received FDA approval in 2011, it is currently no longer marketed in the United States. The Trifecta GT valve, which received approval in 2016, is the only commercially available option still offered by Abbott.

Abbott Heart Valve Replacement Failures

The FDA indicates recent literature highlights the Abbott Trifecta and Trifecta GT heart valve deterioration risks, finding that the devices are failing within the first five years, with a peak failure rate occurring between three and four years after implantation.

Specifically, the data suggests the Abbott Trifecta valves have failed early due to a condition known as structural valve deterioration (SVD), which can cause narrowing of the aortic valve, regurgitation or a combination of both, requiring surgical intervention. The Trifecta brands have a higher cumulative incident rate of early SVD and higher rate of surgical intervention when compared to other brands of commercially available heart replacement valves across the same post-implant timeframes, according to the scientific data the FDA reviewed.

The agency indicates that the literature points to several potential outcomes of failing Abbott Trifecta valves, including surgical valve explant/replacement, transcatheter valve-in-valve intervention, and death.

Although the FDA’s announcement did not give specific numbers on the reports, an analytics firm which specializes in publicizing adverse medical device events reports that nearly 3,000 adverse events related to the Trifecta valves have been reported since 2011, resulting in over 2,100 injuries and, 191 deaths.

While no recall has been announced, the FDA stated it would be working with Abbott to further evaluate the issues causing early SVD and develop additional patient management strategies as necessary.

In the meantime, officials are encouraging healthcare professionals to be aware of potential SVD risks and to relay these risks to patients when considering available options. Patients who have already underwent Trifecta or Trifecta GTZZ implants should be closely monitored for the onset of new symptoms such as shortness of breath or fatigue.

Any and all adverse events related to the Abbott heart replacement valves should be promptly reported to the FDA’s MedWatch safety information system. Device manufacturers and user facilities are being reminded of their mandatory compliance to report any adverse events through the applicable Medical Device Reporting (MDR) regulations.