Love J W, Schoen F J, Breznock E M, Shermer S P, Love C S
Autogenics, Newbury Park, California.
J Heart Valve Dis. 1992 Nov;1(2):232-41.
The goal of the autologous tissue heart valve (ATHV) prosthesis project has been the development of a non-antigenic, non-calcifying bioprosthesis of greater durability than heterograft or homograft bioprostheses. It is made in the operating room, at a sterile work bench, during surgery for heart valve replacement. Autologous pericardium is used for valve construction after a five minute immersion in 0.6 per cent glutaraldehyde buffered to pH 7.4 with phosphate. The stent-mounted trileaflet prosthesis can be made in five minutes with a semi-automated method that uses two concentric mating stents that substitute clamping for sewing of the tissue. In vitro testing, to include pulse duplicator, accelerated wear tester, static testing for leakage and tensile strength testing, has been performed with ATHVs made with glutaraldehyde-tanned bovine and ovine pericardium. Transvalvular pressure gradients were measured at 3.3-7.3 mmHg at flow rates of 4-5 l/min. Six valves have been tested beyond 800,000,000 cycles with full opening and closing at differential closing pressures of 125 mmHg. One of the valves developed a 2mm leaflet tear after 26,000,000 cycles but the remaining five survived intact. No fractures were seen in the Dacron covered Delrin stents. Six ATHVs were implanted in juvenile sheep for five months. One animal died after five months of infective endocarditis secondary to an unrecognized deep wound infection and the other five were electively sacrificed at the same time interval. Four valves were fully competent at terminal elective cardiac catheterization and one showed minimal insufficiency attributed to a paravalvular leak. The leaflet tissue was free of generalized calcification in all instances. There was no evidence of leaflet tissue thickening or shrinkage. The mean calcium content at necropsy of the 15 leaflets from the five valves was 8.357 mg/g of tissue. There is experimental evidence that an ATHV made of pericardium treated briefly with glutaraldehyde may achieve the goal of a non-calcifying, more durable bioprosthesis.
自体组织心脏瓣膜（ATHV）假体项目的目标是开发一种非抗原性、不钙化的生物假体，其耐久性优于异种移植或同种移植生物假体。它是在手术室的无菌工作台上，在心脏瓣膜置换手术过程中制作的。自体心包在0.6%的戊二醛中浸泡五分钟后用于瓣膜构建，该戊二醛用磷酸盐缓冲至pH值7.4。带有支架的三叶形假体可以用一种半自动方法在五分钟内制成，该方法使用两个同心配合支架，用夹紧代替组织缝合。已经对用戊二醛鞣制的牛和羊心包制成的ATHV进行了体外测试，包括脉搏复制器、加速磨损测试仪、泄漏静态测试和拉伸强度测试。在流速为4 - 5升/分钟时，跨瓣压差测量为3.3 - 7.3毫米汞柱。六个瓣膜在8亿次以上的全开合循环测试中进行了测试，压差关闭压力为125毫米汞柱。其中一个瓣膜在2600万次循环后出现了2毫米的瓣叶撕裂，但其余五个完好无损。在涤纶覆盖的聚甲醛支架中未发现骨折。六个ATHV植入幼年绵羊体内五个月。一只动物在五个月后死于继发于未被识别的深部伤口感染的感染性心内膜炎，其他五只在相同时间间隔被选择性处死。在终末期选择性心脏导管检查时，四个瓣膜功能完全正常，一个因瓣周漏显示轻微功能不全。在所有情况下，瓣叶组织均无普遍钙化。没有证据表明瓣叶组织增厚或萎缩。五个瓣膜的15个瓣叶尸检时的平均钙含量为8.357毫克/克组织。有实验证据表明，用戊二醛短暂处理的心包制成的ATHV可能实现不钙化、更耐用的生物假体的目标。
