Dive Brief:
- The U.S. Food and Drug Administration has warned healthcare professionals about the potential for Abbott’s Trifecta heart valves to deteriorate.
- Based on the published literature, the FDA is concerned that the rate of early deterioration may be higher for Trifecta than for other surgical aortic valve replacement (SAVR) devices such as Edwards Lifesciences’ Magna bioprosthesis.
- The FDA is advising healthcare professionals to discuss the risk of structural valve deterioration with patients and perform lifelong follow-up visits at least once a year for assessment.
Dive Insight:
Abbott, having entered the market through its takeover of St. Jude Medical, competes with Edwards to serve patients who need to replace diseased, damaged and malfunctioning valves with SAVR procedures. In recent years, a series of research papers has compared the rates of structural valve deterioration in recipients of the devices.
Abbott reviewed 21 articles published since 2020 and found that “there appears to be a higher early and midterm cumulative incidence of SVD, and a lower freedom from early and midterm reintervention due to SVD for the Trifecta valve.” Abbott also reviewed the complaints it has received and found that most cases of SVD that occur within five years are “characterized as a non-calcific leaflet tear.” The number of SVD complaints peaks after three years, compared to eight years in Abbott’s clinical trials.
The FDA commented on the medical device report data, noting that the “outcomes include surgical valve explant/replacement, transcatheter valve-in-valve intervention and in some cases death.” Both Abbott and the FDA highlighted the limitations of the passive surveillance data, with the former observing that analyses based on complaints “likely result in under-estimating events due to under-reporting.”
Most of the data come from patients who received the first generation Trifecta valve, which is no longer sold in the U.S. Still, the data suggest the performance of the current Trifecta GT valve is similar, and as such, Abbott’s recommendations for the management of patients apply to the recipients of all devices in its range. The FDA is working with Abbott to evaluate the evidence on the rate of SVD.
