Orszulak T A, Schaff H V, DeSmet J M, Danielson G K, Pluth J R, Puga F J
Section of Thoracic, Cardiovascular, Vascular, and General Surgery, Mayo Clinic, Rochester, MN 55905.
J Thorac Cardiovasc Surg. 1993 Feb;105(2):302-12.
Cardiac valve replacement with use of only the Björk-Shiley prosthesis was performed in 1253 patients between January 1973 and December 1982. There were 828 patients having aortic valve replacement, 280 patients having mitral valve replacement, and 145 patients having double valve replacement with aortic and mitral valve prostheses. Patient outcome was stratified according to multiple variables, including valve position and valve model (spherical versus convexo-concave discs). No valve failure due to strut fracture was identified in 26 high-risk patients (mitral valve replacement with greater than or equal to 29 mm implanted in patients less than or equal to 50 years of age) followed up for a mean of 10 years postoperatively. Fifteen patients had late thrombosis of their Björk-Shiley prosthesis (0.28 per 100 patient-years), but there was no significant difference in risk of valve thrombosis comparing the spherical and convexo-concave discs (0.27 per 100 patient-years versus 0.27 per 100 patient-years). One hundred two patients had 128 thromboembolic episodes; rates of thromboembolism after aortic valve replacement, mitral valve replacement, and double valve replacement were 2.1, 4.3, and 4.6 per 100 patient-years, respectively. Percentages of patients free from thromboemboli after aortic valve replacement, mitral valve replacement, and double valve replacement were 93% +/- 1%, 86% +/- 2%, and 89% +/- 3% at 5 years postoperatively and 87% +/- 2%, 79% +/- 5%, and 77% +/- 8% 10 years postoperatively. There was no significant difference in the rates of thromboemboli for spherical and convexo-concave discs for all patients and for each of the subgroups. Ten-year actuarial survival estimates for patients dismissed alive from the hospital after aortic valve replacement, mitral valve replacement, and double valve replacement with the Björk-Shiley valve were 65% +/- 4%, 63% +/- 5%, and 55% +/- 8%, respectively. Overall event-free survival (freedom from death, thromboembolism, anticoagulant-related bleeding, endocarditis, and reoperation) was similar for the three patient groups. Performance of the Björk-Shiley valve as judged by late patient follow-up is similar to other mechanical valves, and modifications in disc design do not appear to have reduced the threat of late valve thrombosis and thromboemboli. Evidence does not support elective explantation of this prosthesis.
1973年1月至1982年12月期间，1253例患者仅使用比约克-希利人工瓣膜进行了心脏瓣膜置换术。其中828例患者进行了主动脉瓣置换，280例患者进行了二尖瓣置换，145例患者进行了主动脉瓣和二尖瓣双瓣膜置换。根据多个变量对患者结局进行分层，包括瓣膜位置和瓣膜型号（球形瓣与凸凹形瓣）。在26例高危患者（年龄小于或等于50岁、植入二尖瓣且尺寸大于或等于29mm）中，术后平均随访10年，未发现因支柱骨折导致的瓣膜失效。15例患者的比约克-希利人工瓣膜发生晚期血栓形成（每100患者年0.28例），但球形瓣与凸凹形瓣的瓣膜血栓形成风险无显著差异（每100患者年0.27例与每100患者年0.27例）。102例患者发生了128次血栓栓塞事件；主动脉瓣置换、二尖瓣置换和双瓣膜置换后血栓栓塞的发生率分别为每100患者年2.1例、4.3例和4.6例。主动脉瓣置换、二尖瓣置换和双瓣膜置换术后5年无血栓栓塞的患者百分比分别为93%±1%、86%±2%和89%±3%，术后10年分别为87%±2%、79%±5%和77%±8%。所有患者及各亚组中，球形瓣与凸凹形瓣的血栓栓塞发生率无显著差异。接受比约克-希利瓣膜进行主动脉瓣置换、二尖瓣置换和双瓣膜置换后出院存活患者的10年精算生存率估计分别为65%±4%、63%±5%和55%±捌%。三组患者的总体无事件生存率（无死亡、血栓栓塞、抗凝相关出血、心内膜炎和再次手术）相似。根据患者晚期随访判断，比约克-希利瓣膜的性能与其他机械瓣膜相似，瓣膜设计的改进似乎并未降低晚期瓣膜血栓形成和血栓栓塞的风险。现有证据不支持对该人工瓣膜进行择期取出。
