Method for preclinical pathology evaluation and analysis of cardiovascular implantable electronic device implant sites.

Autor: Jessen SL; Department of Biomedical Engineering, Texas A&M University, College Station, TX, USA., O'Brien MT; Department of Veterinary Pathobiology, Texas A&M University, College Station, TX, USA., Lancon TW; Department of Nuclear Engineering, Texas A&M University, College Station, TX, USA., Smith HR; Department of Biomedical Engineering, Texas A&M University, College Station, TX, USA., Suarez LL; Department of Veterinary Integrative Biosciences, Texas A&M University, College Station, TX, USA., Wilcox MD; Department of Biomedical Engineering, Texas A&M University, College Station, TX, USA., Miller M; Texas A&M Institute for Preclinical Studies, Texas A&M University, College Station, TX, USA., Weeks BR; Department of Veterinary Pathobiology, Texas A&M University, College Station, TX, USA., Clubb FJ Jr; Department of Biomedical Engineering, Texas A&M University, College Station, TX, USA; Department of Veterinary Pathobiology, Texas A&M University, College Station, TX, USA. Electronic address: fclubb@cvm.tamu.edu.
Jazyk: angličtina
Zdroj: Cardiovascular pathology : the official journal of the Society for Cardiovascular Pathology [Cardiovasc Pathol] 2018 Sep - Oct; Vol. 36, pp. 44-52. Date of Electronic Publication: 2018 May 18.
DOI: 10.1016/j.carpath.2018.05.002
Abstrakt: Cardiovascular implantable electronic devices (CIEDs) typically incorporate leads that directly contact the endocardium. Post-explant pathology evaluation of formalin-fixed CIED lead implant sites and downstream organs (i.e., lungs) can provide useful safety data to the US Food and Drug Administration; however, current regulatory guidelines do not mandate how the safety data are collected. In this paper, we outline a protocol for preclinical pathology evaluation of leads associated with CIEDs, which includes formalin fixation of the heart and lungs, gross evaluation, and qualitative and quantitative histologic evaluation. We recommend fixation of the whole heart with leads in situ alongside intratracheal formalin infusion; this enables rapid and effective preservation of target tissues and increases histologic quality to allow for accurate qualitative and quantitative pathology evaluation. Overall, we believe that our approach to pathology evaluation of leads may maximize information acquired from preclinical studies, leading to more accurate safety assessments.
Summary: This article introduces an established method for pathology evaluation and analysis of cardiac leads recommended for companies and researchers that seek approval from a regulatory body.
(Copyright © 2018. Published by Elsevier Inc.)
Databáze: MEDLINE
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