A randomized assessment of an advanced tissue preservation technology in the juvenile sheep model
A randomized assessment of an advanced tissue preservation technology in the juvenile sheep model
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DOI：
10.1016/j.jtcvs.2014.09.062
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发表时间：
2015-01-01
影响因子：
6
通讯作者：
Meuris, Bart
中科院分区：
文献类型：
--
作者：
Flameng, Willem;Hermans, Hadewich;Meuris, Bart
背景：尽管抗钙化技术得到了改进，但由于瓣膜结构的进行性退化，生物瓣膜仍不能用于年轻患者。开发了一种新的先进的组织保存技术，该技术采用稳定的官能团封端和甘油化保存。采用这项新技术的阀门可以在干燥条件下储存，使用前不需要清洗。本研究的目的是评价这项新技术在慢性绵羊原位植入模型中对瓣膜功能和耐用性的影响。方法：将45只幼年绵羊随机分为两组，分别植入Perimount二尖瓣(对照组，6900P)和采用新组织保存技术的相同设计的二尖瓣(试验组)。所有瓣膜均为25 mm。分别于术后1周和8个月行经胸超声心动图检查。然后处死动物，进行尸检，并对瓣膜进行放射学(软组织X线片)、组织学(苏木精-伊红和Von Kossa染色)和化学(钙含量)检查。排除标准包括手术或程序死亡、细菌性心内膜炎或其他导致过早死亡的疾病。结果：31只动物(14只对照动物和17只实验动物)在8个月的随访期内保持良好状态。术后1周超声心动图显示两组瓣膜功能正常。在8个月时，两组患者的心输出量均有相同程度的增加(与基线相比；P<；0.01)。平均跨瓣压差也有所增加，但对照组明显高于试验组(P=0.03)。与测试瓣膜相比，控制瓣膜中的流动湍流度增加。试验瓣膜的钙含量显著低于对照组(1.9+/-0.3vs6.8+/-1.6微克/毫克；P=0.002)。结论：新的组织保存技术应用于Perimount二尖瓣时，与目前被认为是标准护理标准的Perimount二尖瓣相比，显著改善了血流动力学和抗钙化特性。
Background: Despite improved anticalcification technology, bioprosthetic heart valves still cannot be used in younger patients because of progressive structural valve degeneration. A novel advanced tissue preservation technology was developed that uses stable functional group capping and preservation by glycerolization. Valves incorporating this novel technology can be stored in a dry condition and do not require rinsing before use. The aim of the study was to assess the effects of this new technology in terms of valve function and durability in a chronic sheep model of orthotopic implantation.Methods: Forty-five juvenile sheep were randomized and either a Perimount mitral valve (6900P, control group) or the same valve design incorporating the novel tissue preservation technology (test group) was implanted in the mitral position. All valves were 25 mm. A transthoracic echocardiography was performed at 1 week and at 8 months postoperatively. The animals were then killed, an autopsy was performed, and the valves were examined radiographically (soft tissue radiograph), histologically (hematoxylin and eosin and Von Kossa staining), and chemically (calcium content). Exclusion criteria for analysis included surgical or procedural death, bacterial endocarditis or other diseases leading to premature death.Results: Thirty-one animals (14 controls and 17 test animals) remained in perfect condition during the 8-month follow-up period. Echocardiography at 1 week showed normal valve function in both groups. At 8 months, cardiac output increased significantly to the same extent in both groups (vs baseline; P < .01). The mean transvalvular pressure gradient also increased but significantly more in the control group compared with the test group (P = .03). Flow turbulence across the prosthesis was increased in the control valves compared with the test valves. The test valves had significantly less calcium content than the controls (1.9 +/- 0.3 vs 6.8 +/- 1.6 mu g/mg; P = .002). This was confirmed by radiographic analysis and histology.Conclusions: This study demonstrates that the novel tissue preservation technology, when applied to the Perimount mitral valve, significantly improves hemodynamic and anticalcification properties compared with the standard Perimount, a valve currently considered the standard of care.