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Clinical Inferences of Cardiovascular Implantable Electronic Device Analysis at Autopsy
Sunil K Sinha1, Barbara Crain2, Katie Flickinger2
1Division of Cardiology, Johns Hopkins University School of Medicine, Baltimore, Maryland.
Insights
Routine post-mortem analysis of cardiovascular implantable electronic devices (CIEDs) aids in determining cause of death, especially in sudden cardiac death cases. This diagnostic tool can also identify device malfunctions, improving future patient safety.
Area of Science:
- Forensic Pathology
- Cardiology
- Biomedical Engineering
Background:
- Autopsy examination of cardiovascular implantable electronic devices (CIEDs) is recommended in suspected sudden cardiac death cases.
- Limited data exists on the utility of routine, nonselective post-mortem CIED analysis.
Purpose of the Study:
- To evaluate the diagnostic value of systematic CIED removal, interrogation, and analysis during autopsy.
- To determine the clinical utility of post-mortem CIED analysis in various death scenarios.
Main Methods:
- Analysis of a registry of autopsies performed at a single institution.
- CIEDs (pacemakers and defibrillators) were removed, interrogated by electrophysiologists, and submitted for manufacturer analysis.
- Data on CIED alerts, autopsy findings, and causes of death were cataloged.
Main Results:
- Of 2,025 autopsies, 84 involved CIED analysis.
- Significant clinical alerts were observed in 62.8% of sudden deaths and 19.5% of non-sudden deaths.
- CIED alerts showed significant associations with sudden death, defibrillators, and cardiac causes of death. Device malfunctions were identified.
Conclusions:
- Post-mortem CIED analysis is clinically useful for determining the timing, mechanism, and cause of death in sudden and non-sudden death cases.
- Routine CIED removal and analysis should be considered an important diagnostic tool in all autopsies.
- This analysis can assist manufacturers in identifying device failures.
Background:
Cardiovascular implantable electronic device (CIED) removal and interrogation are recommended at autopsy in suspected cases of sudden cardiac death, but data on the role of nonselective post-mortem CIED (pacemaker or defibrillator) analysis in this setting are lacking.
Objectives:
This study undertook an institutional registry analysis to determine the utility of systematic routine CIED removal, interrogation, and analysis at autopsy.
Methods:
From May 19, 2009, to May 18, 2015, autopsy subjects with a CIED at a Johns Hopkins University medical institution (Baltimore, Maryland) underwent CIED removal and interrogation by an electrophysiologist for clinical alerts. The CIED was then submitted for technical analysis by the manufacturer. The CIED interrogation, the manufacturer's technical analysis, and the final autopsy report were all cataloged in the Johns Hopkins Post-mortem CIED Registry.
Results:
A total of 2,025 autopsies were performed; 84 subjects had CIEDs removed and analyzed. These devices included 37 pacemakers and 47 defibrillators. Overall, 43 subjects had died suddenly, and 41 had not died suddenly. Significant clinical alerts (sustained tachyarrhythmias or an elevated fluid index value) were seen in 62.8% cases of sudden deaths. In the nonsudden death cohort, 19.5% displayed a significant clinical alert. Significant association of CIED alerts were noted when comparing sudden deaths versus nonsudden deaths (p < 0.001), defibrillators versus pacemakers (p < 0.005), and cardiac versus noncardiac causes of death (p < 0.001). Manufacturer analyses revealed a case of premature pacemaker battery depletion, as well as a hard reset in a defibrillator as a result of cold exposure.
Conclusions:
Post-mortem CIED analysis was clinically useful in assisting with determination of the timing, mechanism, and cause of death in the majority of sudden deaths and in almost 20% of nonsudden deaths. The authors advocate CIED removal with analysis as an important diagnostic tool in all autopsies and to assist manufacturers in identifying potentially fatal device failures.
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