O'Brien M F, Stafford E G, Gardner M A, Pohlner P G, Tesar P J, Kear L, Smith S E
Department of Cardiac Surgery, Prince Charles Hospital, Brisbane, Australia.
Ann Thorac Surg. 1995 Aug;60(2 Suppl):S253-7. doi: 10.1016/0003-4975(95)00534-r.
Three hundred forty-two patients from December 1985 to January 1993 received 352 Medtronic Intact porcine xenograft valves (zero-pressure glutaraldehyde-fixed with toluidine blue anticalcification agent). The follow-up was 99.4% complete with a mean of 3.14 years (3 months to 7.9 years). The mean patient age was 64 years (range, 16 to 82 years) and the median age was 67 years. There were 14 aortic valve replacement patients (11.9%) and 62 mitral valve replacement patients (29.2%) who preoperatively were in New York Heart Association class IV to V. The hospital mortality was 8.4% +/- 2.9% (aortic valve replacement, 5.9%; mitral valve replacement, 9.4%; tricuspid valve replacement, 7.6%). Actuarial patient survival at 7 years was 65% +/- 5% (aortic valve replacement, 77% +/- 5%; mitral valve replacement, 63% +/- 5%). At 7 years, the freedom from thromboembolism was 74% +/- 4%, freedom from endocarditis 93% +/- 2%, and freedom from reoperation 90% +/- 3%. Reoperation was required for endocarditis (7 patients), periprosthetic leak (6), and 2 of 3 cases of structural deterioration. The actuarial freedom from structural deterioration at 5 years was 97% +/- 3%. The combined incidence of all important morbid valve-related events was analyzed with an actuarial freedom at 7 years of 63% +/- 3%. The durability of the Medtronic Intact is at least equal to that of other porcine bioprostheses. The relevant important time-frame of 7 to 12 years of follow-up has just begun, and possibly the reoperation rate for intrinsic value failure and the low incidence of calcification in the elderly patient may be showing improved characteristics of this valve. No stronger inferences are possible at this stage of the 7-year follow-up.
1985年12月至1993年1月期间，342例患者接受了352枚美敦力Intact猪异种移植瓣膜（零压力戊二醛固定并添加甲苯胺蓝抗钙化剂）。随访率为99.4%，平均随访时间为3.14年（3个月至7.9年）。患者平均年龄为64岁（范围16至82岁），年龄中位数为67岁。术前纽约心脏协会心功能分级为IV至V级的患者中，有14例接受主动脉瓣置换（11.9%），62例接受二尖瓣置换（29.2%）。医院死亡率为8.4%±2.9%（主动脉瓣置换为5.9%；二尖瓣置换为9.4%；三尖瓣置换为7.6%）。7年时患者的精算生存率为65%±5%（主动脉瓣置换为77%±5%；二尖瓣置换为63%±5%）。7年时，无血栓栓塞的概率为74%±4%，无心内膜炎的概率为93%±2%，无需再次手术的概率为90%±3%。再次手术的原因包括心内膜炎（7例）、人工瓣膜周漏（6例）以及3例结构退化中的2例。5年时结构退化的精算无发生率为97%±3%。分析所有重要的与瓣膜相关的不良事件的综合发生率，7年时的精算无发生率为63%±3%。美敦力Intact瓣膜的耐久性至少与其他猪生物瓣膜相当。7至12年的相关重要随访时间框架才刚刚开始，可能这种瓣膜在老年患者中因固有瓣膜功能衰竭导致的再次手术率以及钙化低发生率方面会表现出更好的特性。在7年随访的这个阶段，无法得出更强有力的推断。
