TY - JOUR
T1 - Paravalvular leak and other events in silzone-coated mechanical heart valves
T2 - A report from AVERT
AU - Schaff, Hartzell V.
AU - Carrel, Thierry P.
AU - Jamieson, W. R.Eric
AU - Jones, Kent W.
AU - Rufilanchas, Juán José
AU - Cooley, Denton A.
AU - Hetzer, Roland
AU - Stumpe, Frank
AU - Duveau, Daniel
AU - Moseley, Patterson
AU - Van Boven, Wim Jan
AU - Grunkemeier, Gary L.
AU - Kennard, Elizabeth D.
AU - Holubkov, Richard
PY - 2002
Y1 - 2002
N2 - Background. 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. Methods. 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). Results. 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. Conclusions. Continued follow-up of AVERT supports the conclusion that the Silzone prosthesis has increased risk of paravalvular leakage requiring reoperation. Overall survival is similar in the two groups.
AB - Background. 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. Methods. 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). Results. 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. Conclusions. Continued follow-up of AVERT supports the conclusion that the Silzone prosthesis has increased risk of paravalvular leakage requiring reoperation. Overall survival is similar in the two groups.
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U2 - 10.1016/S0003-4975(01)03442-7
DO - 10.1016/S0003-4975(01)03442-7
M3 - Article
C2 - 11899956
AN - SCOPUS:0036192171
SN - 0003-4975
VL - 73
SP - 785
EP - 792
JO - Annals of Thoracic Surgery
JF - Annals of Thoracic Surgery
IS - 3
ER -