Oyer P E, Stinson E B, Griepp R B, Shumway N E
Ann Surg. 1977 Sep;186(3):301-9. doi: 10.1097/00000658-197709000-00008.
Although the Starr-Edwards caged-ball valve remains a standard of comparison for more recently introduced prostheses, a substantial incidence of thromboembolic and hemorrhagic complications prompted our evaluation of the Hancock glutaraldehyde-fixed porcine xenograft. We have compared the results of 435 aortic valve replacements using the Starr- Edwards valve (SE-AVR), 515 mitral valve replacements (SE-MVR), and 121 double-valve replacements (SE-AVRMVR) with 251 aortic valve replacements using the xenograft aortic valve (X-AVR), 338 mitral valve replacements (X-MVR), and 88 double-valve replacements (X-AVR-MVR). The Starr- Edwards valves were used during the period 1963 through 1973 and the xenograft valves between 1971 and 1976. No significant differences in patient age, sex, or preoperative hemodynamic data were noted between comparable groups. All patients with Starr-Edwards valves received long-term anticoagulation while anticoagulants were used only for specific indications in patients with xenograft valves. Total follow up was 3944 patient years for the Starr-Edwards patients and 947 patient years for the xenograft patients. Hospital mortality was not significantly different for comparable groups: SE-AVR 6.9% vs. X-AVR 6.4%, SE-MVR 9.7% vs X-MVR 8.6%, and SE-AVR-MVR 7.5% vs. X-AVR-MVR 10.2%. Linearized mortality and morbidity data expressed as percent per patient- year are tabulated below. Pairs which differ significantly (p < .05) are italicized.
尽管Starr-Edwards笼球瓣仍是用于比较近期推出的人工瓣膜的标准,但血栓栓塞和出血并发症的发生率较高,促使我们对汉考克戊二醛固定猪异种移植物进行评估。我们比较了435例使用Starr-Edwards瓣膜进行主动脉瓣置换术(SE-AVR)、515例二尖瓣置换术(SE-MVR)和121例双瓣膜置换术(SE-AVR-MVR)的结果,以及251例使用异种移植物主动脉瓣进行主动脉瓣置换术(X-AVR)、338例二尖瓣置换术(X-MVR)和88例双瓣膜置换术(X-AVR-MVR)的结果。Starr-Edwards瓣膜在1963年至1973年期间使用,异种移植物瓣膜在1971年至1976年期间使用。在可比组之间,患者年龄、性别或术前血流动力学数据没有显著差异。所有使用Starr-Edwards瓣膜的患者都接受长期抗凝治疗,而抗凝剂仅用于有特定指征的异种移植物瓣膜患者。Starr-Edwards瓣膜患者的总随访时间为3944患者年,异种移植物瓣膜患者为947患者年。可比组的医院死亡率没有显著差异:SE-AVR为6.9%,X-AVR为6.4%;SE-MVR为9.7%,X-MVR为8.6%;SE-AVR-MVR为7.5%,X-AVR-MVR为10.2%。以每年每例患者百分比表示的线性化死亡率和发病率数据如下表所示。差异显著(p < 0.05)的配对用斜体表示。