FDA Advises on Reduced Leaflet Motion in Bioprosthetic Aortic Valves

October 6, 2015—The US Food and Drug Administration (FDA) has issued a notification advising that advanced imaging studies have detected reduced leaflet motion (ie, impaired valve opening) in some bioprosthetic aortic valves, including both surgical and transcatheter aortic valve replacement (SAVR and TAVR) devices. The cause and occurrence rate of reduced leaflet motion and whether or not this finding has clinical implications for patients and patient care is not known. The full notification is available online here. 

The FDA stated that it is working with the American College of Cardiology, the Society of Thoracic Surgeons, and the device manufacturers to design clinical studies to fully evaluate reduced leaflet motion for all types of bioprosthetic aortic valves. At this time, the FDA believes that these devices are reasonably safe and effective when used according to their FDA-approved indications.

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 blood flow through the valve opening without evidence of stenosis.

According to the FDA, the leaflet motion abnormalities were detected using special three- and four-dimensional CT scans or by transesophageal echocardiography. Of note, transthoracic echocardiography, which is the routine imaging method used to assess valve function following implantation, did not reliably detect abnormal leaflet motion.

The FDA advised that most advanced imaging studies have been conducted in TAVR patients, and that may be why there have been more reports of reduced leaflet motion in TAVR patients as compared to SAVR patients. The true rate of reduced leaflet motion for bioprosthetic aortic valves, whether TAVR or SAVR, is not currently known. In the limited available information that the FDA has reviewed regarding advanced imaging studies of bioprosthetic aortic valves, reduced leaflet motion was seen in 10% to 40% of TAVR patients and approximately 8% to 12% of SAVR patients.

The FDA stated that additional comments to the public would be issued when more information becomes available.