Isom O W, Glassman S E, Teiko P, Boyd A D, Cunningham J N, Reed G E
Ann Surg. 1977 Sep;186(3):310-23. doi: 10.1097/00000658-197709000-00009.
The two principal considerations with prosthetic valves are durability and thromboembolism. With the widespread interest in recently developed prosthetic valves (porcine, tilting disc, Cooley), the long-term results at one institution with a single prosthesis were considered of particular importance. Accordingly, a 97% follow-up has been completed on 1375 patients (pts) undergoing prosthetic valve replacement with the Starr-Edwards cloth-covered steel ball prosthesis at New York University between October 1967 and December 1975. Operative procedures were as follows: aortic valve replacement (AVR): 470 pts; mitral valve replacement (MVR): 362 pts; combined AVR and MVR: 129 pts; other combined procedures: 414 pts. Overall operative deaths were 13.7%, 9% for AVR, 10.8% for MVR, and 18.6% for combined AVR and MVR. At seven years, AVR survival was 64%, and MVR survival 64.5%. There has been widespread pessimism, usually without significant data, about the cloth-covered prosthesis, because of concern of cloth wear, hemolysis and other complications. Therefore, a particularly significant finding by actuarial analysis was that 85% of surviving patients with isolated AVR remained free of emboli for five years. In pts surviving isolated MVR, 80% remained free of emboli for five years. Of those having embolic episodes, 33% were not on anticoagulants. Fatal hemorrhage from anticoagulants occurred in 0.8% of pts. Endocarditis occurred in 5.7% of the entire group, with 1.3% requiring reoperation. Clinically significant hemolysis occurred in 5.1% of the group, with only 0.2% requiring reoperation. Hence, the total frequency of clinically significant cloth-wear was less than 0.5%. These data indicate both the reliability and the limitations of the Starr-Edwards cloth-covered steel ball valve and can be used in comparing experiences with the more recently developed prostheses.
人工心脏瓣膜主要有两个需要考虑的因素，即耐用性和血栓栓塞。随着人们对最近研发的人工心脏瓣膜（猪瓣膜、倾斜盘式瓣膜、库利瓣膜）的广泛关注，某一机构使用单一假体的长期结果被认为尤为重要。因此，对1967年10月至1975年12月期间在纽约大学接受斯塔尔 - 爱德华兹布覆盖钢球人工心脏瓣膜置换术的1375例患者进行了97%的随访。手术操作如下：主动脉瓣置换术（AVR）：470例患者；二尖瓣置换术（MVR）：362例患者；AVR和MVR联合手术：129例患者；其他联合手术：414例患者。总体手术死亡率为13.7%，AVR为9%，MVR为10.8%，AVR和MVR联合手术为18.6%。七年时，AVR生存率为64%，MVR生存率为64.5%。由于担心布磨损、溶血和其他并发症，人们对布覆盖假体普遍持悲观态度，通常没有显著数据支持。因此，精算分析的一个特别显著发现是，85%存活的孤立AVR患者五年内未发生栓塞。在存活的孤立MVR患者中，80%五年内未发生栓塞。在发生栓塞事件的患者中，33%未使用抗凝剂。抗凝剂导致的致命出血发生在0.8%的患者中。心内膜炎发生在整个组的5.7%，其中1.3%需要再次手术。临床上显著的溶血发生在该组的5.1%，只有0.2%需要再次手术。因此，临床上显著的布磨损总发生率低于0.5%。这些数据表明了斯塔尔 - 爱德华兹布覆盖钢球瓣膜的可靠性和局限性，可用于与最近研发的假体进行经验比较。
