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Novel preclinical method for evaluating the efficacy of a percutaneous treatment in human ex vivo calcified plaque
Medical & Biological Engineering & Computing ( IF 3.2 ) Pub Date : 2021-03-12 , DOI: 10.1007/s11517-021-02334-w
Robert S Chisena 1 , Jordan Sengenberger 2 , Albert J Shih 1 , Hitinder Gurm 3
Affiliation  

The lack of suitable atherosclerotic calcification models and testing strategies inhibits preclinical efficacy testing of existing and novel percutaneous devices. The goal of this study is to develop a preclinical testing method for quantitatively and qualitatively evaluating the efficacy of noncompliant balloon angioplasty (NC BA) treatment in human ex vivo calcified plaque (CP). NC BA using a 3- and 4-mm diameter balloon was performed on an ex vivo tibial calcified vessel obtained from an amputation. Three-dimensional microcomputed tomography (μ-CT) imaging was performed pre- and post-BA to compare crack density in the CP. Comparing the pre- and posttreatment three-dimensional μ-CT images showed a glass-like cracking that occurred in the CP due to the BA procedure. Expansion of the 3-mm balloon showed little tissue deformation and no CP cracking. Although expansion of the 4-mm balloon occurred nonuniformly along balloon length and across the perpendicular projections, the balloon generated cracking throughout the CP, which allowed the surrounding elastic tissue to be dilated. This combined X-ray microscopy and μ-CT technique is a useful preclinical tool for quantifying the efficacy of percutaneous treatments for CP. Because of its nondestructive nature, the CP structure can be visualized pre- and posttreatment to determine the treatment effect.

Graphical abstract



中文翻译:

评估经皮治疗对人体离体钙化斑块疗效的新型临床前方法

缺乏合适的动脉粥样硬化钙化模型和测试策略阻碍了现有和新型经皮装置的临床前功效测试。本研究的目标是开发用于定量和定性地评价在人的不符合要求的球囊血管成形术(NC BA)治疗的功效的临床前检测方法的离体钙化斑块(CP)。使用 3 毫米和 4 毫米直径球囊的 NC BA 在体外进行从截肢中获得的胫骨钙化血管。在 BA 前后进行三维显微计算机断层扫描 (μ-CT) 成像,以比较 CP 中的裂纹密度。比较治疗前和治疗后的三维 μ-CT 图像显示由于 BA 程序在 CP 中发生了玻璃状裂纹。3 毫米球囊的膨胀显示出很少的组织变形和无 CP 开裂。虽然 4 毫米球囊的膨胀沿球囊长度和垂直投影发生不均匀,但球囊在整个 CP 中产生裂纹,这使得周围的弹性组织扩张。这种组合的 X 射线显微镜和 μ-CT 技术是一种有用的临床前工具,可用于量化 CP 经皮治疗的疗效。由于其非破坏性,

图形概要

更新日期:2021-03-12
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