Ten to fifteen year reassessment of the performance characteristics of the Starr-Edwards Model 6120 mitral valve prosthesis.
Ten to fifteen year reassessment of the performance characteristics of the Starr-Edwards Model 6120 mitral valve prosthesis.
复制标题
对 Starr-Edwards 6120 型二尖瓣假体的性能特征进行十到十五年的重新评估。
DOI：
10.1016/s0022-5223(19)38894-4
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发表时间：
1983
期刊：
影响因子：
--
通讯作者：
N. Shumway
中科院分区：
文献类型：
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作者：
D. C. Miller;P. Oyer;E. Stinson;B. Reitz;S. Jamieson;W. Baumgartner;R. Mitchell;N. Shumway
Starr-Edwards（S-E）非织物覆盖的硅胶球假体（型号6120）已广泛用于二尖瓣置换术超过16年。它仍然是比较新型瓣膜的标准，但其在10至15年范围内的性能特征尚未得到全面记录。本研究纳入了509例植入该假体的患者;使用严格、保守和全面的定义，具体参考所有瓣膜相关发病率和死亡率，分析了累计3，170患者-年的随访。用线性化（λ）和精算术语表示，瓣膜相关并发症的发生率如下：22%的医院死亡和27%的晚期死亡与瓣膜相关。总体而言，5年时46% ± 2%的患者发生瓣膜相关并发症，10年时62% ± 3%，14年时75% ± 4%;然而，该假体结构良好，未发现机械失效病例。因此，尽管从纯粹的机械设计角度来看，Starr-Edwards 6120型二尖瓣假体是不可破坏的，但对其性能特征的综合分析显示，总体长期结果明显不佳。当使用较新的机械假体和组织生物假体的患者随访达到10年及以上时，本文定义和报告的瓣膜相关并发症应用于分析比较。通过这种方式，研究者和临床医生都可以辨别“较新”的瓣膜替代品是否真的是“改进”的瓣膜，以及哪种类型的瓣膜替代品在总体瓣膜相关发病率和死亡率方面为患者提供最可能的净受益。
The Starr-Edwards (S-E) non-cloth-covered, silicone ball prosthesis (Model 6120) has been widely used for mitral valve replacement for over 16 years. It remains a standard against which newer valves are compared, but its performance characteristics in the 10 to 15 year range have not been comprehensively documented. This investigation included 509 patients who had this prosthesis implanted; a cumulative total of 3,170 patient-years of follow-up was analyzed with specific reference to all valve-related morbidity and mortality using stringent, conservative, and comprehensive definitions. Expressed in both linearized (λ) and actuarial terms, valve-related complications occurred at the following rates: Twenty-two percent of hospital deaths and 27% of late deaths were valve-related. Overall, 46% ± 2% of patients had had a valve-related complication by 5 years, 62% ± 3% by 10 years, and fully 75% ± 4% by 14 years; however, this prosthesis was structurally sound and no cases of mechanical failure were identified. Thus, although the Starr-Edwards Model 6120 mitral prosthesis is indestructible from purely a mechanical design standpoint, this comprehensive analysis of its performance characteristics reveals markedly suboptimal overall long-term results. The valve-related complications defined and reported herein should be used for analytical comparison when follow-up of patients with newer mechanical prostheses and tissue bioprostheses reaches 10 years and beyond. In this way, investigators and clinicians alike can discern whether or not a “newer” valve substitute is really an “improved” valve and which type of valve substitute proffers the most possible net benefit to the patient in terms of overall valve-related morbidity and mortality.