Journal article
Adverse events related to AtriCure EPi-Sense Coagulation Device-Analysis of the FDA MAUDE database
Journal of cardiovascular electrophysiology, Vol.33(2), pp.151-153
02/01/2022
DOI: 10.1111/jce.15287
PMCID: PMC8813877
PMID: 34750929
Abstract
Introduction The AtriCure EPi-Sense Device is used for the hybrid convergent procedure, an emerging treatment for persistent atrial fibrillation (AF) and long-standing persistent AF. However, data on the AE related to the EPi-Sense device are scarce. Methods Keyword "EPI-SENSE" was searched on the MAUDE database. There were 80 device reports from 2016 to 2020. After excluding reports when the device was not returned for evaluation, 79 device reports were included for final analysis. Results The adverse events (AE) were broadly classified into 11 categories. The most common complications were pericardial effusion (25.3%), stroke (17.7%), and atrioesophageal fistula (AEF) (8.9%). Death was reported in 15 (19%) cases, 3 of which were due to pulmonary embolism, 6 due to AEF, 3 due to unknown cause, 1 due to sepsis, 2 due to events related to acute renal failure. Discussion Pericardial effusion is a common AE reported in patients with convergence procedures and is well documented in the CONVERGE trial. The convergent procedure is unique in that the epicardial ablations are performed on the posterior wall with the radiofrequency probe directed towards the heart and away from the esophagus which in theory should reduce esophageal injuries. Despite that, a high number of AEF were noticed. Finally, there were also some reports of saline perfusion malfunction which can lead to injuries due to overheating. Conclusion This analysis of the AE related to the EPi-Sense device highlights several major AE that are previously unreported.
Details
- Title: Subtitle
- Adverse events related to AtriCure EPi-Sense Coagulation Device-Analysis of the FDA MAUDE database
- Creators
- Aakash R. Sheth - Louisiana State University Health Sciences Center ShreveportZaki Al Yafeai - Louisiana State University Health Sciences Center ShreveportPaari Dominic - Louisiana State University Health Sciences Center Shreveport
- Resource Type
- Journal article
- Publication Details
- Journal of cardiovascular electrophysiology, Vol.33(2), pp.151-153
- DOI
- 10.1111/jce.15287
- PMID
- 34750929
- PMCID
- PMC8813877
- NLM abbreviation
- J Cardiovasc Electrophysiol
- ISSN
- 1045-3873
- eISSN
- 1540-8167
- Publisher
- Wiley
- Number of pages
- 3
- Grant note
- P20GM121307 / National Institute of General Medical Sciences of the National Institutes of Health; United States Department of Health & Human Services; National Institutes of Health (NIH) - USA; NIH National Institute of General Medical Sciences (NIGMS)
- Language
- English
- Date published
- 02/01/2022
- Academic Unit
- Internal Medicine
- Record Identifier
- 9984367233302771
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