Method for preclinical pathology evaluation and analysis of cardiovascular implantable electronic device implant sites.
Cardiovasc Pathol
; 36: 44-52, 2018.
Article
em En
| MEDLINE
| ID: mdl-30014985
ABSTRACT
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.Palavras-chave
Texto completo:
1
Bases de dados:
MEDLINE
Assunto principal:
Marca-Passo Artificial
/
Reação a Corpo Estranho
/
Fixação de Tecidos
/
Desfibriladores Implantáveis
/
Pulmão
/
Miocárdio
Tipo de estudo:
Etiology_studies
/
Qualitative_research
Limite:
Animals
Idioma:
En
Revista:
Cardiovasc Pathol
Assunto da revista:
ANGIOLOGIA
/
CARDIOLOGIA
/
PATOLOGIA
Ano de publicação:
2018
Tipo de documento:
Article
País de afiliação:
Estados Unidos