Background: The Silzone-coated St. Jude Medical valve (SJM "Silzone" valve), developed to reduce prosthetic valve endocarditis (PVE), was recalled by SJM due to a higher rate of paravalvular leaks. The aim of this study was to determine the efficacy of the SJM "Silzone" valve in avoiding PVE and to evaluate the frequency of paravalvular leaks, when the valve was used exclusively for active bacterial endocarditis.
Methods: From January 1998 to December 1999, the SJM "Silzone" valve was implanted in 40 consecutive patients with active endocarditis (20 aortic, 14 mitral, and 6 both valves). Late transesophageal echocardiography was performed in 87% of survivors, and transthoracic echocardiography in the remaining 13%. Follow-up was 100%.
Results: Hospital mortality was 17.5%. Early PVE occurred in 2 of 40 patients (5%). There were two late deaths without signs of recurrent PVE. A hemodynamic relevant paravalvular leak necessitating reoperation was seen in 2 patients within 6 months after operation. The rate of a minor paravalvular leak was 13% (4 of 31 patients).
Conclusions: The SJM "Silzone" valve when implanted for active bacterial endocarditis does not give better results than other mechanical prostheses with regard to early recurrence of endocarditis. The rate of a hemodynamic relevant paravalvular leak requiring reoperation seems rather high during the early postoperative period, whereas the occurrence of minor paravalvular leaks is comparable with that of other mechanical prostheses. Routine observation, recommended for all patients with mechanical heart valves, is also sufficient for patients with the SJM "Silzone" valve.