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

Staci L. Jessen; Maureen T. OBrien; Trevor W. Lancon; Harrison R. Smith; Leslie L. Suarez; Matthew D. Wilcox; Matthew Miller; Brad R. Weeks; Fred J. Clubb

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

机译：心血管植入电子设备植入部位的临床前病理评价与分析方法

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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.

机译：心血管可植入的电子设备（CIEDS）通常掺入直接接触内膜的引线。后病原体病理学评估福尔马林固定的铅植入部位和下游器官（即肺部）可以为美国食品和药物管理局提供有用的安全数据;但是，目前的监管指南不授权如何收集安全数据。在本文中，我们概述了一种临床前病理评估的铅，其伴随着脊髓碱基，其包括心脏和肺部的福尔马林固定，总评估和定性和定量的组织学评估。我们建议将整个心脏固定在脊椎内福尔林输注的原位原位上的铅;这使得能够快速有效地保存靶组织并增加组织学质量，以便准确定性和定量病理学评估。总体而言，我们认为，我们对铅的病理学评估方法可能最大化从临床前研究获得的信息，导致更准确的安全评估。概述了寻求的公司和研究人员的病理评估和分析的既定方法批准监管机构。

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《Cardiovascular pathology: the official journal of the Society for Cardiovascular Pathology》 |2018年第2018期|共9页
作者
Staci L. Jessen; Maureen T. OBrien; Trevor W. Lancon; Harrison R. Smith; Leslie L. Suarez; Matthew D. Wilcox; Matthew Miller; Brad R. Weeks; Fred J. Clubb;
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作者单位

Department of Biomedical Engineering Texas A&

M University;

Department of Veterinary Pathobiology Texas A&

M University;

Department of Nuclear Engineering Texas A&

M University College Station;

Department of Biomedical Engineering Texas A&

M University;

Department of Veterinary Integrative Biosciences Texas A&

M University;

Department of Biomedical Engineering Texas A&

M University;

Texas A&

M Institute for Preclinical Studies Texas A&

M University;

Department of Veterinary Pathobiology Texas A&

M University;

Department of Biomedical Engineering Texas A&

M University;

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原文格式 PDF
正文语种 eng
中图分类心脏、血管（循环系）疾病;
关键词
Pathology; CIEDs; Device regulation recommendations;

机译：病理学;CIEDS;设备规则建议;

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机译：心血管植入电子设备植入部位的临床前病理评价与分析方法
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5. Analysis of soft encapsulation methods for acutely implantable high-channel count neural recording electronics. [D] . Taylor, Trevor Winn. 2014

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

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