PMID: 11899956Mar 20, 2002Paper

Paravalvular leak and other events in silzone-coated mechanical heart valves: a report from AVERT

The Annals of Thoracic Surgery
Hartzell V SchaffArtificial Valve Endocarditis Reduction Trial

Abstract

The Artificial Valve Endocarditis Reduction Trial (AVERT) was designed to compare endocarditis rates in Silzone versus conventional valves. Recruitment ended January 21, 2000, because of higher rates of paravalvular leakage in patients receiving the Silzone prosthesis. The present analysis determined late event rates that might be used in the management of approximately 36,000 patients who have received the Silzone prosthesis. A total of 807 patients in 19 centers in North America and Europe were randomized. Mean age was 61+/-11 years; 41% were women. Operations included aortic valve replacement in 59%, mitral valve replacement in 32%, and aortic and mitral valve replacements in 9%; 41% had concomitant operations (26% coronary artery bypass grafting). Major paravalvular leakage (followed by repair, explant, or mortality) occurred in 18 of 403 patients receiving Silzone valves and 4 of 404 patients without Silzone valves (2-year event-free rates: 91.1% versus 98.9% conventional, p < 0.003). Similarly, 2-year freedom from any explant was lower in the Silzone arm (19 versus 2 events; 90.1% versus 99.4%, p = 0.0002). Rates of mortality and stroke were similar during follow-up. Continued follow-up of AVERT supports the conclusion th...Continue Reading

Associated Clinical Trials

References

Nov 14, 1997·ASAIO Journal : a Peer-reviewed Journal of the American Society for Artificial Internal Organs·K S TwedenE Tobin

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Citations

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