Jamieson W R, Allen P, Miyagishima R T, Gerein A N, Munro A I, Burr L H, Tyers G F
Department of Surgery, University of British Columbia, Vancouver, Canada.
J Thorac Cardiovasc Surg. 1990 Mar;99(3):543-61.
The Carpentier-Edwards standard porcine bioprosthesis was implanted in 1190 patients (1201 operations, 1303 valves) between January 1975 and June 1986; most implants were before 1982. The mean age of the patients was 57.2 years (range 8 to 85 years). The early mortality was 7.6% (aortic valve replacement 5.1%, mitral valve replacement 8.8%, and multiple valve replacement 15.3%). Late mortality was 3.9% per patient-year (aortic valve replacement 3.6%, mitral valve replacement 4.2%, and multiple valve replacement 3.8%). The total cumulative follow-up period was 6737 years. Thromboembolism was 1.5% per patient-year (fatal 0.4% per patient-year) (minor 0.6%, major 0.9%); antithromboembolic therapy-related hemorrhage was 0.5% (fatal 0.1%); prosthetic valve endocarditis was 0.6% (fatal 0.2%); nonstructural dysfunction was 0.5% (fatal 0.2%); and structural valve deterioration and/or primary tissue failure was 1.5% per patient-year (fatal, 0.2% per patient-year). Thromboembolism and structural valve deterioration were the significant complications, structural valve deterioration occurring primarily between the sixth and 10th year of evaluation. The overall patient survival was 65.0% for aortic valve replacement and 54.8% for mitral valve replacement (p less than 0.05) at 10 years. The patients were classified as 92.9% New York Heart Association functional classes III and IV preoperatively and 92.3% classes I and II postoperatively. Freedom at 10 years from thromboembolism was 84.3% for aortic valve replacement and 76.5% for mitral valve replacement (p = 0.05); structural valve deterioration was 78.6% for aortic valve replacement and 71.6% for mitral valve replacement (p less than 0.05); reoperation was 74.4% for aortic valve replacement and 67.1% for mitral valve replacement (p less than 0.05). Freedom from all valve-related complications at 10 years was 58.9% for aortic valve replacement and 46.8% for mitral valve replacement (p less than 0.05); valve-related mortality was 89.5% for aortic valve replacement and 82.6% for mitral valve replacement (p = not significant); mortality and reoperation was 58.9% for aortic valve replacement and 46.8% for mitral valve replacement (p less than 0.05); mortality and residual morbidity (treatment failure) was 87.2% for aortic valve replacement and 75.1% for mitral valve replacement (p = not significant); mortality, residual morbidity, and reoperation were 66.3% for aortic valve replacement and 54.9% for mitral valve replacement (p less than 0.05). The standard Carpentier-Edwards porcine bioprosthesis has provided satisfactory clinical performance and has afforded patients excellent quality of life.
1975年1月至1986年6月期间，1190例患者（1201次手术，1303枚瓣膜）植入了Carpentier-Edwards标准猪生物瓣膜；大多数植入手术在1982年之前进行。患者的平均年龄为57.2岁（范围8至85岁）。早期死亡率为7.6%（主动脉瓣置换术为5.1%，二尖瓣置换术为8.8%，多瓣膜置换术为15.3%）。晚期死亡率为每年3.9%（主动脉瓣置换术为3.6%，二尖瓣置换术为4.2%，多瓣膜置换术为3.8%）。总累积随访期为6737年。血栓栓塞发生率为每年1.5%（致命性血栓栓塞为每年0.4%）（轻微血栓栓塞为0.6%，严重血栓栓塞为0.9%）；抗血栓栓塞治疗相关出血发生率为0.5%（致命性出血为0.1%）；人工瓣膜心内膜炎发生率为0.6%（致命性为0.2%）；非结构性功能障碍发生率为0.5%（致命性为0.2%）；瓣膜结构恶化和/或原发性组织衰竭发生率为每年1.5%（致命性为每年0.2%）。血栓栓塞和瓣膜结构恶化是主要并发症，瓣膜结构恶化主要发生在评估的第6年至第10年之间。10年时，主动脉瓣置换术患者的总体生存率为65.0%，二尖瓣置换术患者为54.8%（p<0.05）。术前患者纽约心脏协会功能分级为III级和IV级的占92.9%，术后为I级和II级的占92.3%。10年时，主动脉瓣置换术患者免于血栓栓塞的比例为84.3%，二尖瓣置换术患者为76.5%（p = 0.05）；主动脉瓣置换术患者瓣膜结构恶化的比例为78.6%，二尖瓣置换术患者为71.6%（p<0.05）；主动脉瓣置换术患者再次手术的比例为74.4%，二尖瓣置换术患者为67.1%（p<0.05）。10年时，主动脉瓣置换术患者免于所有瓣膜相关并发症的比例为58.9%，二尖瓣置换术患者为46.8%（p<0.05）；瓣膜相关死亡率主动脉瓣置换术患者为89.5%，二尖瓣置换术患者为82.6%（p无显著性差异）；死亡率和再次手术率主动脉瓣置换术患者为58.9%，二尖瓣置换术患者为46.8%（p<0.05）；死亡率和残余发病率（治疗失败）主动脉瓣置换术患者为87.2%，二尖瓣置换术患者为75.1%（p无显著性差异）；死亡率、残余发病率和再次手术率主动脉瓣置换术患者为66.3%，二尖瓣置换术患者为54.9%（p<0.05）。Carpentier-Edwards标准猪生物瓣膜提供了令人满意的临床性能，并为患者带来了良好的生活质量。
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