[Long-term clinical results with the Starr-Edwards Model 6120 mitral valve prosthesis].

This investigation included 101 patients who had Starr-Edwards silicone ball prosthesis (Model 6120) implanted at the Tokyo Women's Medical College Daini Hospital from 1981 to 1991. A cumulative total of follow-up was 657.0 pt-years. For these patients 102 prostheses were used. The mean follow-up period was 6.5 +/- 3.3 (0.2-11.9) years, and follow-up data were obtained for 100% of the patients. This investigation examined all valve related morbidity and mortality. Late deaths occurred in 14 patients. Thromboembolism occurred in 19 patients, for a predicted freedom from this complication of 82.8% at 5 years, and 78.2% at 10 years. The linearized rate of late death due to thromboembolism was 2.9%/pt-year. There were four cases of anticoagulation-related hemorrhage (ACH), one case of endocarditis and two cases of valve failure. The linearized incidence of ACH was 0.6%/pt-year, that of PVE was 0.2%/pt-year and that of valve failure was 0.3%/pt-year. The estimated actuarial survival was 95% at one year, 86.6% at 5 years and 80% at 10 years. The performance characteristics of the Starr-Edwards Ball Valve (Model 6120) in our institute showed superior structural durability of this prosthesis. Conclusions; 1) The high level of structural durability of the Starr-Edwards Ball Valve (Model 6120) was reconfirmed. 2) This study demonstrated a high level of clinical performance of the SEBV Model 6120. 3) Risk factors affecting the late death and thromboembolism were analyzed.