FDA Warning: Blood Clot Risk Linked to Some Heart Valves

FDA Links Blood Clot Risk to Some Heart ValvesOctober 7, 2015 — The FDA is warning that blood clots may prevent some aortic valve implants from opening and closing properly.

The safety concern emerged after a study was published in the New England Journal of Medicine by Dr. Raj Makkar of Cedars-Sinai Heart Institute in Los Angeles.

He found that 22 out of 44 (40%) of patients with a valve made by St. Jude Medical had reduced aortic-valve leaflet movement. Looking at data from two registries tracking tissue valve replacements, 17 out of 132 (13%) patients had the problem.

Overall, six patients had a stroke or “mini-stroke” (transient ischemic attack). The risk of stroke was higher in patients whose valve was not opening properly, but the size of the study was too small to be conclusive.

The FDA is only concerned about bioprosthetic aortic valves, which are made from cow, pig, or human tissue. Each valve has three leaflets that open and close to keep blood moving in one direction.

The aortic valve controls blood-flow between the left ventricle (main pumping chamber) and the aorta, which carries oxygen-rich blood to the body.

Valves that don’t open fully can restrict blood-flow (stenosis). Valves that don’t close allow blood to flow backward through the heart (regurgitation). Blood clots in the heart are also concerning because they can travel to the brain and cause a stroke.

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