Published literature suggests a higher cumulative incidence of early structural valve deterioration (SVD) for Trifecta valves compared to other commercially available valves, according to a letter to healthcare providers that the FDA published today. The definition of early, in this case, is five years or less.
The Trifecta valves treat diseased, damaged, or malfunctioning native or prosthetic aortic heart valves. FDA approved the first Trifecta valve from St. Jude Medical in 2011, approving the next-gen Trifecta GT in 2016. Abbott completed its $25 billion purchase of St. Jude in 2017.
The communication covers both the original Trifecta valve and the Trifecta GT.
Abbott has marketed the Trifecta valve with Glide Technology (GT) and Linx anticalcification technology as offering exceptional hemodynamic performance. It’s possible to implant the valve via a minimally invasive procedure or conventional surgical aortic valve replacement.
Reports of early Trifecta SVD
The FDA said it has received medical device reports (MDRs) that describe early SVD with Trifecta valves, with reports showing a peak time to SVD of three to four years post-implant. Said the FDA: “Reported outcomes include surgical valve explant/replacement, transcatheter valve-in-valve intervention, and in some cases death.” (Note: The FDA acknowledged the limitations of MDR data, which involves a passive surveillance reporting system.)
The FDA communication didn’t share numbers. But a Device Events search of MDRs shows that the Trifecta valves have 2,384 MDRs dating back to 2011. They include reports listing 2,118 injuries, 191 deaths, and 75 malfunctions.
The FDA said it is working with Abbott to further evaluate the issue and develop additional patient management strategies. The agency will continue to monitor the literature and adverse events reports and alert the public when any significant, new information or recommendations become available.
For its part, Abbott, in its letter to health providers, listed steps to better catch SVDs. For example, Abbott said doctors should remind patients to seek medical attention with new onset of symptoms such as shortness of breath or fatigue.
Senior editor Danielle Kirsh contributed to this report.
