The Starr-Edwards Model 6000 Valve A Fifteen-Year Follow-up of the First Successful Mitral Prosthesis

SUMMARY The Starr-Edwards Model 6000 mitral valve was the first successful mitral prosthesis. A fifteen year follow-up of 110 patients undergoing isolated mitral valve replacement with this prosthesis from 1960 to 1966 is presented. There were 22 (20%) operative and 37 (42%) late deaths at a mean of 8.6 years post-operatively. Preoperative variables leading to late death and throm-THE STARR-EDWARDS MODEL 6000 mitral valve, in-troduced in 1960,1 was the first artificial valve prosthesis to enjoy widespread clinical use. The basic design incorporated a silastic ball in a cage of Stellite-2 1 with a cloth sewing ring. The outflow and inflow faces were metallic and the struts rather thick and elongated compared to modern designs. Due to problems with thromboembolism, the 6000 mitral valve was superceded by the Model 6120 in February 1966. Since then, additional modifications have emerged, and have been the subject of several reviews.2` Despite advances in valve design, our interest in the 6000 mitral valve remains strong for its historical significance, as well as for the ongoing care of those patients who continue to rely on this prosthesis. These patients represent the longest follow-up available on any prosthetic cardiac device and provide a baseline against which the biocompatibility of all subsequent modifications can be judged. For these reasons, a retrospective review of the clinical course of these patients over the past 15 years was initiated