| St. Jude Heart Valve
People implanted with St. Jude mechanical heart valves with Silzone
coated sewing cuffs ("silzone valves") may be at higher risk for
paravalvular leak. For this reason, on January 21, 2000, St. Jude
Medical Inc. instituted a recall of all silzone valves that had
not yet been implanted into patients.
There is also a concern that persons implanted with Silzone valves
face higher risks of thrombus formation, thrombosis and stroke.
A thrombus is a blood clot that can form upon the valve, affecting
its operation or even rendering it inoperable. Thrombosis is a condition
in which blood clots form and then move through the blood stream.
These clots can ultimately cause a transient ischemic attack (TIA)
or a stroke due to thromboembolism.
In November of 1999, The Medical Device Agency in London issued
an Advice entitled "Thromboembolic Complications involving SilzoneŽ
Mechanical Heart Valves." This bulletin reported a study in the
United Kingdom of 51 patients implanted with silzone valves. Seven
of these patients suffered a stroke. Upon reviewing the data, the
Society of Cardiothoracic Surgeons of Great Britain and Ireland
confirmed that there is a greater thromboembolic event rate associated
with silzone valves compared to standard St. Jude mechanical heart
valves. This data was presented at a recent meeting of the American
Heart Association in Atlanta.
That data compared two groups of patients, 118 persons implanted
with standard St. Jude valves and 75 patients implanted with silzone
valves. The data showed that persons implanted with the silzone
valves had much higher incidences of stroke and major embolism.
The increase in incidence was greatest among patients implanted
with either a mitral silzone valve or both a mitral and aortic silzone
valve.
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