Who have a prosthetic ring in the tricuspid position.An aortic heart valve that is not calcified, contains only one leaflet, has leaflets with large pieces of calcium that may block the vessels that supply blood to the heart or in which the main problem is that the valve leaks. The safety and effectiveness of the transcatheter heart valves are also not known for patients who have: Patients should be treated post-procedure for heart infection as a precaution. Patients who need a dental procedure should talk to their doctor about risk of infection and needing antibiotics. In addition, patient age should be considered as long-term durability of the valve has not been established. A patient’s anatomical characteristics should be considered by their physicians when using the valve in this patient population. Limited clinical data are available for transcatheter aortic valve replacement in patients who are born with an aortic heart valve that has only two leaflets and who are determined to be at low risk for open heart surgery. Regular medical follow-up is recommended to evaluate how well a patient’s heart valve is performing. The long-term durability of the Edwards SAPIEN 3 Ultra, SAPIEN 3 Ultra RESILIA and SAPIEN 3 transcatheter heart valves are not known at this time.
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