Jamieson W R, Janusz M T, Miyagishima R T, Munro A I, Gerein A N, Allen P, Burr L H, MacNab J, Chan F, Tyers G F
Division of Cardiovascular and Thoracic Surgery, University of British Columbia, Vancouver, Canada.
J Card Surg. 1988 Sep;3(3 Suppl):321-36. doi: 10.1111/jocs.1988.3.3s.321.
The Carpentier-Edwards standard porcine bioprosthesis was implanted in 1,000 operations (988 patients with 1,092 valves) between 1975 and 1981. The mean age of the patients was 56.8 years (range 8 to 85 years). During the years 1975 and 1981, approximately 97% of the total valvular surgery population received the prosthesis. The early mortality was 7.8% (including patients with concomitant procedures including coronary artery bypass and ascending aortic aneurysm resection). Late mortality was 3.8% per patient-year. The total cumulative follow-up was 5,937 years. Thromboembolism (TE) was 1.3% per patient-year (fatal 0.4%/patient-year) (minor 0.4%; major 0.9%); antithromboembolic therapy-related hemorrhage (ATH) 0.5% (fatal 0.1%); prosthetic valve endocarditis (PVE) 0.5% (fatal 0.2%); periprosthetic leak (PPL) 0.4% (fatal 0.2%); clinical valve dysfunction (CVD) 0.2% (fatal 0.02%); and structural valve deterioration (SVD)/primary tissue failure 1.6% per patient-year (fatal 0.2%/pt-yr). Thromboembolism and SVD occurring primarily between the sixth and tenth year of evaluation, were the significant complications. The overall patient survival was 60.5% +/- 2.4% at 10 years. The patients were classified as 93.5% NYHA functional Class III and IV, preoperatively and 93.1% Class I and II, postoperatively. The freedom at 10 years from TE was 82.9% +/- 2.7%; SVD 76.9% +/- 2.9%; and reoperation 70.8% +/- 3.1%. Freedom from all valve-related complications at 10 years was 54.3% +/- 3.1%; valve-related mortality 86.4% +/- 2.3%; mortality and reoperation (valve failure) 64.0% +/- 3.2%; mortality and residual morbidity (treatment failure) 82.3% +/- 2.6%; and mortality, residual morbidity, and reoperation (valve failure and dysfunction) 60.6% +/- 3.2%. There were 61 valve-related deaths of a total 352 deaths (early 7, late 54) (TE 21; ATH 7; CVD 1; PVE 12; PPL 9; and SVD 11). Valve-related reoperations were performed in 128 patients (TE 3; CVD 4; PVE 14; PPL 17; and SVD 90). The standard Carpentier-Edwards porcine bioprosthesis has provided very satisfactory clinical performance and afforded patients excellent quality of life. Primary tissue failure is the significant long-term complication.
1975年至1981年间，1000例手术（988例患者，共植入1092枚瓣膜）中植入了Carpentier-Edwards标准猪生物瓣膜。患者的平均年龄为56.8岁（范围8至85岁）。在1975年至1981年期间，瓣膜手术患者总数中约97%接受了该瓣膜植入。早期死亡率为7.8%（包括接受冠状动脉搭桥和升主动脉瘤切除等同期手术的患者）。患者年晚期死亡率为3.8%。总累积随访时间为5937患者年。血栓栓塞（TE）发生率为每患者年1.3%（致命性0.4%/患者年）（轻度0.4%；重度0.9%）；抗血栓栓塞治疗相关出血（ATH）发生率为0.5%（致命性0.1%）；人工瓣膜心内膜炎（PVE）发生率为0.5%（致命性0.2%）；瓣周漏（PPL）发生率为0.4%（致命性0.2%）；临床瓣膜功能障碍（CVD）发生率为0.2%（致命性0.02%）；结构瓣膜退变（SVD）/原发性组织衰竭发生率为每患者年1.6%（致命性0.2%/患者年）。血栓栓塞和SVD主要发生在评估的第6年至第10年，是主要并发症。10年时总体患者生存率为60.5%±2.4%。术前患者93.5%为纽约心脏协会（NYHA）功能分级III级和IV级，术后93.1%为I级和II级。10年时无血栓栓塞的概率为82.9%±2.7%；无SVD的概率为76.9%±2.9%；无需再次手术的概率为70.8%±3.1%。10年时无所有瓣膜相关并发症的概率为54.3%±3.1%；瓣膜相关死亡率为86.4%±2.3%；死亡率和再次手术（瓣膜功能衰竭）为64.0%±3.2%；死亡率和残余发病率（治疗失败）为82.3%±2.6%；死亡率、残余发病率和再次手术（瓣膜功能衰竭和功能障碍）为60.6%±3.2%。在总共352例死亡病例（早期7例，晚期54例）中有61例与瓣膜相关死亡（血栓栓塞21例；抗血栓栓塞治疗相关出血7例；临床瓣膜功能障碍1例；人工瓣膜心内膜炎12例；瓣周漏9例；结构瓣膜退变11例）。128例患者进行了瓣膜相关再次手术（血栓栓塞3例；临床瓣膜功能障碍4例；人工瓣膜心内膜炎14例；瓣周漏17例；结构瓣膜退变90例）。标准的Carpentier-Edwards猪生物瓣膜提供了非常令人满意的临床表现，并为患者带来了优异的生活质量。原发性组织衰竭是主要的长期并发症。
