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.
Highlights
Implantable hemodynamic monitoring systems designed to facilitate the management of patients with advanced chronic heart failure have recently been investigated with the aim of reducing hospitalizations for acute decompensated heart failure.[1,2,3] One such system is an implantable left atrial pressure (LAP) monitor that is linked to a physician-directed, patient self-management treatment paradigm.[3]
Materials and Methods Integrated microscopy techniques consisting of highresolution gross digital photography followed by micro X-ray, micro-computed tomography scanning, low-vacuum scanning electron microscopy (LVSEM), and microground plastic-embedded histology were applied to the same specimen
All eight specimens demonstrated that the LAP sensor had neoendocardial tissue overgrowth with no excessive host-to-device reaction when implanted through the inter-atrial septum for durations ranging between 3 months and greater than 4K years
Summary
Implantable hemodynamic monitoring systems designed to facilitate the management of patients with advanced chronic heart failure have recently been investigated with the aim of reducing hospitalizations for acute decompensated heart failure.[1,2,3] One such system is an implantable left atrial pressure (LAP) monitor that is linked to a physician-directed, patient self-management treatment paradigm.[3]. Owing to the limited number of specimens available for analysis from the clinical trial setting, it is important to optimally leverage each available specimen. An approach that integrates a series of complimentary microscopic techniques for pathology evaluation was developed to maximize the ß National Society for Histotechnology 2013. 1. Roberts et al Integrated microscopy techniques quality and quantity of data collected from each specimen, while minimizing the number of required specimens for analysis. A detailed description of this integrated microscopic evaluation approach, along with its application to the analysis of a single human specimen containing the LAP sensor, is presented
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