Nistal J F, Hurlé A, Revuelta J M, Gandarillas M
Department of Cardiovascular Surgery, Hospital Marques de Valdecilla, University of Cantabria, Santander, Spain.
J Thorac Cardiovasc Surg. 1996 Jul;112(1):59-68. doi: 10.1016/s0022-5223(96)70178-2.
Between January 1989 and August 1992, 612 CarboMedics mechanical prostheses (CarboMedics, Inc., Austin, Tex.) (295 mitral, 308 aortic, and 9 tricuspid) were implanted in 504 patients: 189 patients had isolated mitral valve replacement, 209 had isolated aortic valve replacement, and 106 had multiple valve replacement. The total follow-up was 1182 patient-years. The hospital mortality rate was 7.4% for mitral valve replacement, 5.3% for aortic valve replacement, and 13.2% for multiple valve replacement. Linearized rates for the different complications for mitral valve replacement, aortic valve replacement, and multiple valve replacement (in events per 100 patient-years) were, respectively, as follows: late mortality, 2.6 +/- 0.8, 1.5 +/- 0.5, and 3.9 +/- 1.3; thromboembolism [correction of thromboembolim], 3.7 +/- 0.9, 3.1 +/- 0.8, and 3.9 +/- 1.3; valve thrombosis, 0.5 +/- 0.3 for mitral valve replacement and 0.4 +/- 0.4 for multiple valve replacement; anticoagulant-related hemorrhage, 2.8 +/- 0.8, 1.9 +/- 0.6, and 2.6 +/- 1.1; nonstructural dysfunction, 1.6 +/- 0.6, 0.8 +/- 0.4, and 3.5 +/- 1.2; and reoperation, 1.1 +/- 0.5, 0.4 +/- 0.3, and 3.1 +/- 1.1. Actuarial estimates of freedom from the different complications for mitral valve replacement, aortic valve replacement, and multiple valve replacement (at 5 years of follow-up for mitral valve replacement and aortic valve replacement and 4.5 years for multiple valve replacement) were, respectively, as follows: overall death, 83% +/- 4%, 89% +/- 2%, and 76% +/- 4%; thromboembolism or valve thrombosis, 88% +/- 3%, 91% +/- 2%, and 86% +/- 5%; anticoagulant-related hemorrhage, 89% +/- 3%, 95% +/- 2%, and 90% +/- 5%; nonstructural dysfunction, 97% +/- 1%, 98% +/- 1%, and 91% +/- 3%; and reoperation, 96% +/- 2%, 99% +/- 1%, and 87% +/- 5%. There were no instances of prosthetic structural dysfunction. The performance of the CarboMedics valve is satisfactory at 5 years of follow-up but thromboembolic and hemorrhagic phenomena are still serious complications of mechanical prostheses.
1989年1月至1992年8月期间，504例患者植入了612个CarboMedics机械瓣膜（CarboMedics公司，得克萨斯州奥斯汀）（295个二尖瓣、308个主动脉瓣和9个三尖瓣）：189例患者接受单纯二尖瓣置换术，209例接受单纯主动脉瓣置换术，106例接受多瓣膜置换术。总随访时间为1182患者年。二尖瓣置换术的医院死亡率为7.4%，主动脉瓣置换术为5.3%，多瓣膜置换术为13.2%。二尖瓣置换术、主动脉瓣置换术和多瓣膜置换术不同并发症的线性化发生率（每100患者年的事件数）分别如下：晚期死亡率，2.6±0.8、1.5±0.5和3.9±1.3；血栓栓塞[纠正血栓栓塞]，3.7±0.9、3.1±0.8和3.9±1.3；瓣膜血栓形成，二尖瓣置换术为0.5±0.3，多瓣膜置换术为0.4±0.4；抗凝相关出血，2.8±0.8、1.9±0.6和2.6±1.1；非结构性功能障碍，1.6±0.6、0.8±0.4和3.5±1.2；再次手术，1.1±0.5、0.4±0.3和3.1±1.1。二尖瓣置换术、主动脉瓣置换术和多瓣膜置换术不同并发症无事件生存率的精算估计（二尖瓣置换术和主动脉瓣置换术随访5年，多瓣膜置换术随访4.5年）分别如下：总体死亡，83%±4%、89%±2%和76%±4%；血栓栓塞或瓣膜血栓形成，88%±3%、91%±2%和86%±5%；抗凝相关出血，89%±3%、95%±2%和90%±5%；非结构性功能障碍，97%±1%、98%±1%和91%±3%；再次手术，96%±2%、99%±1%和87%±5%。未发生人工瓣膜结构性功能障碍。随访5年时，CarboMedics瓣膜的性能令人满意，但血栓栓塞和出血现象仍是机械瓣膜的严重并发症。
