Prospective Randomized Study of the St. Jude Medical®, BjÖrk-Shiley®, and Starr-Edwards® 6120 Valve Prostheses in the Mitral Position
During a 5-year period (January 1979 to December 1983), 357 patients received mitral valve replacement. Group A was comprised of 179 patients receiving a ST. JUDE MEDICAL® prosthesis in the mitral position. Group B included 178 patients; initially 113 patients were implanted with a BJÖRK-SHILEY® valve, and later 65 patients received a STARR-EDWARDS® 6120 valve prosthesis in the mitral position. All implants were performed by the same surgeon and the groups were randomized. Analysis of 21 preoperative (clinical and hemodynamic data) and operative variables showed the groups to be well randomized. All patients were anticoagulated postoperatively. A follow-up study was performed each year postoperatively. At the end of 1986, there was a 35-month to 95-month follow-up with a mean of 64.7 months (1596 patient-years of follow-up). Fifteen patients were lost to follow-up. The actuarial survival rate is significantly different (p < 0.05) at 5 years with 87.6 ± 4.5% for Group A vs. 77.4 ± 6% for Group B, and at 7 years with 83.4 ± 6.5% for Group A vs. 73.2 ± 7.2% for Group B. In conclusion, in the mitral position, the ST. JUDE MEDICAL prosthesis gives a significant benefit compared to BJÖRK-SHILEY or STARR-EDWARDS 6120 prostheses.
KeywordsValve Replacement Aortic Valve Replacement Mitral Valve Replacement Jude Medical Valve Prosthesis
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