Brizard Christian P, Brink Johann, Horton Steven B, Edwards Glenn Anthony, Galati John C, Neethling William M L
Cardiac Surgery Department, Royal Childrens Hospital, Melbourne, Victoria, Australia; Murdoch Children's Research Institute, Parkville, Victoria, Australia; Department of Pediatrics, University of Melbourne, Parkville, Victoria, Australia.
Cardiac Surgery Department, Royal Childrens Hospital, Melbourne, Victoria, Australia.
J Thorac Cardiovasc Surg. 2014 Dec;148(6):3194-201. doi: 10.1016/j.jtcvs.2014.08.002. Epub 2014 Aug 7.
To conduct a test of noninferiority for CardioCel (Admedus, Brisbane, Australia), a chemically engineered bovine pericardium over autologous pericardium treated intraoperatively with glutaraldehyde in a chronic juvenile sheep model of pulmonary valve (PV) and mitral valve (MV) reconstruction.
We replaced the posterior leaflet of the MV and of 1 PV cusp with patches in ewes aged 10 months. There were 2 groups: CardioCel (n = 6) and control (n = 4). All valves were competent. Echocardiography was performed before euthanasia. The collected data were function, macroscopy, histology, and calcium contents. The primary end points were thickening and calcium content.
All animals survived until sacrifice after 7 months. The valves had normal echo. The macroscopic aspect of the valves was excellent. Examination of the slides for both groups revealed a continuous endothelium on both sides of the patch and a layer of new collagen developed on both sides between patch and endothelium and interstitial cells and smooth muscle cell in these layers. The patch had not thickened but the 2 layers of new collagen for the PV showed a median thickening of 37% in the CardioCel group and 111% in the control group (P = .01), and for the MV a thickening of 108% and 251%, respectively, was seen (P = .01). The median calcium content in the PV was 0.24 μg/mg (range, 0.19-0.30) in the CardioCel group versus 0.34 μg/mg (range, 0.24-0.62) in controls (P = .20). In the MV it was 0.46 μg/mg (range, 0.30-1.0) in the CardioCel group and 0.47 μg/mg (range, 0.29-1.9) in controls (P = 1.0).
In this growing lamb model the CardioCel patch allowed accurate valve repair at both systemic and pulmonary pressure. The mechanical properties of CardioCel after 7 months were preserved with a more controlled healing than the treated autologous pericardium and without calcification.
在慢性幼年绵羊肺动脉瓣（PV）和二尖瓣（MV）重建模型中，对化学工程处理的牛心包CardioCel（澳大利亚布里斯班的Admedus公司生产）与术中用戊二醛处理的自体心包进行非劣效性测试。
我们用补片替换了10月龄母羊的MV后叶和1个PV瓣叶。分为两组：CardioCel组（n = 6）和对照组（n = 4）。所有瓣膜功能正常。在安乐死之前进行了超声心动图检查。收集的数据包括功能、大体观察、组织学和钙含量。主要终点是增厚和钙含量。
所有动物在7个月后存活至处死。瓣膜回声正常。瓣膜的大体外观良好。两组玻片检查均显示补片两侧有连续的内皮，补片与内皮之间两侧有一层新形成的胶原，这些层中有间质细胞和平滑肌细胞。补片未增厚，但PV的两层新胶原在CardioCel组中位增厚37%，对照组为111%（P = .01），MV的增厚分别为108%和251%（P = .01）。CardioCel组PV的中位钙含量为0.24μg/mg（范围0.19 - 0.30），对照组为0.34μg/mg（范围0.24 - 0.62）（P = .20）。MV中，CardioCel组为0.46μg/mg（范围0.30 - 1.0），对照组为0.47μg/mg（范围0.29 - 1.9）（P = 1.0）。
在这个生长中的羔羊模型中，CardioCel补片在体循环和肺循环压力下均能实现精确的瓣膜修复。7个月后，CardioCel的机械性能得以保留，愈合过程比处理过的自体心包更可控，且无钙化。
