October 7, 2015 — The FDA has issued a Safety Communication about a possible risk of blood clots restricting movement of bioprosthetic aortic heart valves.
Concerns emerged after Dr. Raj Makkar of Cedars-Sinai Heart Institute in Los Angeles published a study in the New England Journal of Medicine.
Dr. Makkar found that 40% (22/44) of patients with a bioprosthetic aortic heart valve made by St. Jude Medical had impaired leaflet motion, possible due to blood clots. After looking at a registry involving 132 patients with devices made by other manufacturers, 17 (13%) had the problem.
Overall, six patients had a stroke or transient ischemic attack (also known as “mini-stroke”). The risk of stroke was higher for patients who were having problems with their heart valves, but the study was too small to draw any conclusions.
Bioprosthetic heart valves are made from cow, pig, or human tissue and are implanted in the aortic valve, which controls blood-flow from the main pumping chamber of the heart (left ventricle) and the rest of the body.
The valves are designed with three leaflets that keep blood moving in one direction. The problem is that blood clots may be preventing the valves from opening fully, which could potentially cause stenosis or strokes. However, more studies are needed to investigate the risk.
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