Abstract The safety and efficacy of an implantable left atrial pressure (LAP) monitoring system is being evaluated in a clinical trial setting. Because the number of available specimens from the clinical trial for histopathology analysis is limited, it is beneficial to maximize the usage of each available specimen by relying on integrated microscopy techniques. The aim of this study is to demonstrate how a comprehensive pathology analysis of a single specimen may be reliably achieved using integrated microscopy techniques. Integrated microscopy techniques consisting of high-resolution gross digital photography followed by micro-computed tomography (micro-CT) scanning, low-vacuum scanning electron microscopy (LVSEM), and microground histology with special stains were applied to the same specimen. Integrated microscopy techniques were applied to eight human specimens. Micro-CT evaluation was beneficial for pinpointing the location and position of the device within the tissue, and for identifying any areas of interest or structural flaws that required additional examination. Usage of LVSEM was reliable in analyzing surface topography and cell type without destroying the integrity of the specimen. Following LVSEM, the specimen remained suitable for embedding in plastic and sectioning for light microscopy, using the positional data gathered from the micro-CT to intersect areas of interest in the slide. Finally, hematoxylin and eosin (H&E) and methylene blue staining was deployed on the slides with high-resolution results. The integration of multiple techniques on a single specimen maximized the usage of the limited number of available specimens from the clinical trial setting. Additionally, this integrated microscopic evaluation approach was found to have the added benefit of providing greater assurance of the derived conclusions because it was possible to cross-validate the results from multiple tests on the same specimen.

中文翻译：

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用于植入式左心房压力传感器综合病理学评估的集成显微镜技术

摘要 植入式左心房压力 (LAP) 监测系统的安全性和有效性正在临床试验环境中进行评估。由于临床试验中用于组织病理学分析的可用标本数量有限，因此依靠集成显微镜技术最大限度地利用每个可用标本是有益的。本研究的目的是展示如何使用集成显微镜技术可靠地实现对单个标本的全面病理学分析。将高分辨率大体数字摄影、显微计算机断层扫描 (micro-CT) 扫描、低真空扫描电子显微镜 (LVSEM) 和具有特殊染色的微磨组织学组成的集成显微镜技术应用于同一标本。综合显微镜技术被应用于八个人体标本。Micro-CT 评估有助于精确定位设备在组织内的位置和位置，并有助于识别需要额外检查的任何感兴趣区域或结构缺陷。LVSEM 的使用在分析表面形貌和细胞类型方面是可靠的，而不会破坏样品的完整性。在 LVSEM 之后，使用从微型 CT 收集的位置数据与载玻片中感兴趣的区域相交，样品仍然适合嵌入塑料和切片以进行光学显微镜检查。最后，苏木精和伊红 (H&E) 和亚甲蓝染色被部署在载玻片上，获得高分辨率结果。在单个样本上集成多种技术，最大限度地利用了临床试验环境中有限数量的可用样本。此外，发现这种集成的微观评估方法具有额外的好处，可以为得出的结论提供更大的保证，因为可以对同一样本的多次测试的结果进行交叉验证。