The United States Food and Drug Administration (FDA) has issued an alert concerning reduced leaflet motion in some bioprosthetic aortic valves.
The FDA is aware of recent reports regarding reduced leaflet motion in some bioprosthetic aortic valves, including both surgical aortic valve replacement (SAVR) and transcatheter aortic valve replacement (TAVR) devices. Importantly, most cases of reduced leaflet motion were discovered by advanced imaging studies in patients without symptoms of abnormal bioprosthetic valve function. Further, these studies have shown that in valves with reduced motion of one or more individual leaflets, there was acceptable forward blood flow through the valve opening without evidence of stenosis.
According to the FDA, the definitive cause(s) of reduced leaflet motion in some bioprosthetic aortic valves is not known. Evidence from imaging studies suggests that blood clot (thrombus) deposits on the leaflets may cause restricted motion. The prevalence of reduced leaflet motion was less in patients receiving therapeutic anticoagulation with warfarin compared with those receiving sub-therapeutic or no anticoagulation and with those receiving dual anti-platelet therapy.
At this time, FDA believes that bioprosthetic aortic valves remain reasonably safe and effective when used according to their approved indications. This view is supported by the favorable benefit/risk profile observed in SAVR devices in the 30 years they have been on the market and in TAVR devices in the 8 years they have been in use.
The FDA recommends the following:
For details, please refer to the FDA websites:
http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm465729.htm
http://www.fda.gov/MedicalDevices/Safety/CDRHPostmarketSurveillance/ucm465417.htm
Posted on 6 October 2015