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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. [ABSTRACT FROM AUTHOR]

Abstract: Introduction: For monitoring pulmonary edema secondary to Congestive Heart Failure (CHF), we investigated trends of impedance between implanted electrodes. Methods: ICDs were implanted in 16 dogs and 5 sheep. Right ventricles were paced (230–250 bpm) for several weeks. Impedance was measured every hour along 4 intrathoracic, 2 intracardiac and 4 cardiogenic vectors. Cardiac function was assessed biweekly by catheterization and echocardiography. Left Atrial Pressure (LAP) was measured daily by an implanted sensor. Results: All animals developed CHF after 2–4 weeks of pacing (EF, 52 vs. 34%; LVEDV, 65 vs. 97 ml; LVEDP, 7 vs. 16 mm Hg; LAV, 17 vs. 33 ml; LAP, 7 vs. 26 mm Hg). Impedance decreased during CHF: LV-Can, ; LV–RV, ; LV–RA, ; RV-Can, ; RV coil-Can, ; RA-Can, . The LV-Can decrease was greatest and correlated well with LAP (). All impedances were associated with circadian variability at the baseline, which diminished during CHF ( vs. ). In CHF, cardiogenic impedances displayed reduced peak-to-peak amplitude and increased fractionation. Conclusions: As impedance decreased during CHF, left-heart trends were better correlated with LAP. Left-heart vectors may improve the detection of CHF compared to sensing by right-heart leads alone. This approach has important clinical implications for managing HF patients in ambulatory settings. [Copyright &y& Elsevier]