title: Integrated microscopy techniques for comprehensive pathology evaluation of an implantable left atrial pressure sensor.
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.
authors.affiliation: Department of Veterinary Pathobiology, Texas A&M University, College Station, TX, USA.
authors.forename: A
authors.initials: A
authors.lastname: Roberts
authors.affiliation: Department of Veterinary Pathobiology, Texas A&M University, College Station, TX, USA.
authors.forename: K E
authors.initials: KE
authors.lastname: Trainor
authors.affiliation: Department of Veterinary Pathobiology, Texas A&M University, College Station, TX, USA.
authors.forename: B
authors.initials: B
authors.lastname: Weeks
authors.affiliation: Department of Veterinary Pathobiology, Texas A&M University, College Station, TX, USA.
authors.forename: N
authors.initials: N
authors.lastname: Jackson
authors.affiliation: Department of Cardiology, Christchurch Hospital and University of Otago, Christchurch, New Zealand.
authors.forename: R W
authors.initials: RW
authors.lastname: Troughton
authors.affiliation: Department of Cardiology, Christchurch Hospital and University of Otago, Christchurch, New Zealand.
authors.forename: C J
authors.initials: CJ
authors.lastname: Charles
authors.affiliation: Department of Cardiology, Christchurch Hospital and University of Otago, Christchurch, New Zealand.
authors.forename: M T
authors.initials: MT
authors.lastname: Rademaker
authors.affiliation: Department of Cardiology, Christchurch Hospital and University of Otago, Christchurch, New Zealand.
authors.forename: I C
authors.initials: IC
authors.lastname: Melton
authors.affiliation: Department of Cardiology, Christchurch Hospital and University of Otago, Christchurch, New Zealand.
authors.forename: I G
authors.initials: IG
authors.lastname: Crozier
authors.affiliation: St. Jude Medical, Cardiac Rhythm Management Division, Sylmar, CA, USA.
authors.forename: W
authors.initials: W
authors.lastname: Hafelfinger
authors.affiliation: St. Jude Medical, Cardiac Rhythm Management Division, Sylmar, CA, USA.
authors.forename: D E
authors.initials: DE
authors.lastname: Gutfinger
authors.affiliation: St. Jude Medical, Cardiac Rhythm Management Division, Sylmar, CA, USA.
authors.forename: N L
authors.initials: NL
authors.lastname: Eigler
authors.affiliation: Division of Cardiovascular Medicine, Ohio State University, Columbus, OH, USA.
authors.forename: W T
authors.initials: WT
authors.lastname: Abraham
authors.affiliation: Department of Veterinary Pathobiology, Texas A&M University, College Station, TX, USA.
authors.forename: F J
authors.initials: FJ
authors.lastname: Clubb
keywords: Histopathology; Left atrial pressure monitor; Medical device evaluation; Medical implant; Micro-computed tomography; Plastic histology; Scanning electron microscopy