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

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.

Source: Cardiovascular Pathology - May 18, 2018 Category: Cardiology Authors: Staci L. Jessen, Maureen T. O'Brien, Trevor W. Lancon, Harrison R. Smith, Leslie L. Suarez, Matthew D. Wilcox, Matthew Miller, Brad R. Weeks, Fred J. Clubb Tags: Original Article Source Type: research