Jamieson W R, Munro A I, Miyagishima R T, Allen P, Janusz M T, Gerein A N, Burr L H, Ling H, Hayden R I, Tutassura H
Division of Cardiovascular and Thoracic Surgery, University of British Columbia, Vancouver, Canada.
J Card Surg. 1988 Dec;3(4):507-21. doi: 10.1111/j.1540-8191.1988.tb00445.x.
The Carpentier-Edwards supra-annular porcine bioprosthesis was implanted in 1,576 operations (1,536 patients with 1,704 valves) between 1981 and 1987. The mean age of the patients was 61.9 years (range 13 to 87 years). During the years 1981 and 1987, approximately 90% of the total valvular surgery population received the prosthesis. The early mortality was 7.0% (included patients with concomitant procedures including coronary artery bypass and ascending aortic aneurysm resection). Late mortality was 4.0% per patient-year. The total cumulative follow-up was 4,237 years. Thromboembolism (TE) was 2.4% per patient-year (fatal 0.4% per patient-year) (minor 1.2%; major 1.3%); antithromboembolic therapy-related hemorrhage (ATH) 0.5% (fatal 0.07%); prosthetic valve endocarditis (PVE) 0.5% (fatal 0.2%); periprosthetic leak (PPL) 0.3% (fatal 0%); clinical valve dysfunction (CVD) 0.3% (fatal 0.02%); and structural valve deterioration/primary tissue failure (SVD) 0.2%/patient-year (fatal 0%). Thromboembolism and structural valve deterioration were the significant complications, SVD occurring primarily between the fourth and fifth year of evaluation. The overall patient survival was 77.1% +/- 1.4% at five years. The patients were classified as 89.6% NYHA functional Class III and IV preoperatively and 96.1% Class I and II postoperatively. The freedom at five years from TE was 90.6% +/- 1.0%; SVD 98.9% +/- 0.5%; and reoperation 95.9% +/- 0.9%. Freedom from all valve-related complications at five years was 84.1% +/- 1.3%; valve-related mortality 96.8% +/- 0.7%; mortality and reoperation (valve failure) 92.9% +/- 1.1%; mortality and residual morbidity (treatment failure) 93.7% +/- 0.9%; and mortality, residual morbidity, and reoperation (valve failure and dysfunction) 90.0% +/- 1.2%. There were 28 valve-related deaths of a total 280 deaths (early 4, late 24) (TE 17; ATH 3; CVD 1; PVE 7; PPL 0; and SVD 0). Valve-related reoperations were performed in 32 patients (TE 2; CVD 4; PVE 7; PPL 11; and SVD 8). The supra-annular Carpentier-Edwards porcine bioprosthesis has provided very satisfactory clinical performance and afforded patients an excellent quality of life. The long-term durability of this low pressure glutaraldehyde fixed prosthesis will be determined by observation over the next five to seven years.
1981年至1987年间，1576例手术（1536例患者，共植入1704枚瓣膜）植入了卡朋蒂埃 - 爱德华兹超环型猪生物瓣膜。患者的平均年龄为61.9岁（范围13至87岁）。在1981年至1987年期间，瓣膜手术患者总数中约90%接受了该瓣膜植入。早期死亡率为7.0%（包括接受冠状动脉搭桥和升主动脉瘤切除术等同期手术的患者）。晚期死亡率为每年4.0%。总累积随访时间为4237人年。血栓栓塞（TE）发生率为每年2.4%（致命性血栓栓塞每年0.4%）（轻度1.2%；重度1.3%）；抗血栓栓塞治疗相关出血（ATH）0.5%（致命性出血0.07%）；人工瓣膜心内膜炎（PVE）0.5%（致命性0.2%）；瓣周漏（PPL）0.3%（致命性0%）；临床瓣膜功能障碍（CVD）0.3%（致命性0.02%）；以及结构瓣膜退变/原发性组织衰竭（SVD）每年0.2%（致命性0%）。血栓栓塞和结构瓣膜退变是主要并发症，SVD主要发生在评估的第四年和第五年之间。五年时总体患者生存率为77.1%±1.4%。术前患者89.6%为纽约心脏协会（NYHA）心功能Ⅲ级和Ⅳ级，术后96.1%为Ⅰ级和Ⅱ级。五年时无血栓栓塞的概率为90.6%±1.0%；无SVD的概率为98.9%±0.5%；再次手术率为95.9%±0.9%。五年时无所有瓣膜相关并发症的概率为84.1%±1.3%；瓣膜相关死亡率为96.8%±0.7%；死亡率和再次手术（瓣膜衰竭）为92.9%±1.1%；死亡率和残余发病率（治疗失败）为93.7%±0.9%；死亡率、残余发病率和再次手术（瓣膜衰竭和功能障碍）为90.0%±1.2%。在总共280例死亡病例中有28例与瓣膜相关（早期4例，晚期24例）（血栓栓塞17例；抗血栓栓塞治疗相关出血3例；临床瓣膜功能障碍1例；人工瓣膜心内膜炎7例；瓣周漏0例；结构瓣膜退变0例）。32例患者进行了与瓣膜相关的再次手术（血栓栓塞2例；临床瓣膜功能障碍4例；人工瓣膜心内膜炎7例；瓣周漏11例；结构瓣膜退变8例）。超环型卡朋蒂埃 - 爱德华兹猪生物瓣膜提供了非常令人满意的临床性能，并为患者带来了出色的生活质量。这种低压戊二醛固定瓣膜的长期耐用性将通过未来五到七年的观察来确定。
