Jamieson W R, Burr L H, Tyers G F, Miyagishima R T, Janusz M T, Ling H, Fradet G J, MacNab J, Chan F, Henderson C
Division of Cardiovascular and Thoracic Surgery, University of British Columbia, Vancouver, Canada.
Ann Thorac Surg. 1995 Aug;60(2 Suppl):S235-40. doi: 10.1016/0003-4975(95)00301-z.
The Carpentier-Edwards supraannular porcine bioprosthesis, a second-generation biologic prosthesis, has had clinical performance assessment to 12 years. This bioprosthesis was used in 2,489 operations in 2,444 patients between 1982 and 1992, inclusive (mean age 64.1 years, age range 6 to 89 years). There were 1,335 aortic valve replacements (AVR), 938 mitral valve replacements (MVR), and 200 multiple valve replacements (MR). Concomitant procedures were performed in 1,017 cases (40.9%). The age group distribution was: 35 years or younger, 83 patients; 36 to 50 years, 245; 51 to 64 years, 728; 65 to 69 years, 458; and 70 years and older, 975. The total follow-up was 12,785 patient-years (mean, 5.1 years) and was 96% complete. The early mortality rate was 7.4% (185 patients), and the late mortality was 4.9%/patient year (623). Concomitant procedures influenced both early and late mortality (p < 0.05). The overall patient survival at 12 years was 44% +/- 3% (p < 0.05, AVR > MVR, MR). The freedom from thromboembolism was not different by valve position. The freedom from major thromboembolism at 12 years was 82% +/- 4% (p = not significant by valve position). The overall freedom from antithromboembolic hemorrhage was 96% +/- 1% at 12 years (p < 0.05, AVR > MVR > MR). The overall freedom from valve-related reoperation at 12 years was 58% +/- 5% (p < 0.05, AVR > MVR, MR), and from valve-related mortality 89% +/- 2% (p < 0.05, AVR > MVR > MR). The freedom from residual morbidity (permanent impairment) at 12 years was 87% +/- 4% (p = not significant by valve position).(ABSTRACT TRUNCATED AT 250 WORDS)
卡朋蒂埃 - 爱德华兹超环猪生物瓣膜作为第二代生物假体，已进行了长达12年的临床性能评估。1982年至1992年（含）期间，该生物假体应用于2444例患者的2489例手术中（平均年龄64.1岁，年龄范围6至89岁）。其中有1335例主动脉瓣置换术（AVR）、938例二尖瓣置换术（MVR）和200例多瓣膜置换术（MR）。1017例（40.9%）患者同时进行了其他手术。年龄组分布为：35岁及以下，83例患者；36至50岁，245例；51至64岁，728例；65至69岁，458例；70岁及以上，975例。总随访时间为12785患者年（平均5.1年），随访完成率为96%。早期死亡率为7.4%（185例患者），晚期死亡率为4.9%/患者年（623例）。同期手术对早期和晚期死亡率均有影响（p<0.05）。12年时的总体患者生存率为44%±3%（p<0.05，AVR>MVR，MR）。血栓栓塞发生率在不同瓣膜位置无差异。12年时无重大血栓栓塞的发生率为82%±4%（按瓣膜位置p无统计学意义）。12年时抗血栓栓塞性出血的总体发生率为96%±1%（p<0.05，AVR>MVR>MR）。12年时瓣膜相关再次手术的总体发生率为58%±5%（p<0.05，AVR>MVR，MR），瓣膜相关死亡率为89%±2%（p<0.05，AVR>MVR>MR）。12年时无残余疾病（永久性损伤）的发生率为87%±4%（按瓣膜位置p无统计学意义）。（摘要截短至250字）
