Adverse events related to Atricure EPi-Sense Coagulation Device -
Analysis of the FDA MAUDE database
Abstract
Introduction: The Atricure EPi-Sense Device is used for the hybrid
convergent procedure, an emerging treatment for persistent atrial
fibrillation and long standing persistent atrial fibrillation. 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 2016-2020. After excluding reports when the device
was not returned for evaluation, 79 device reports were included for
final analysis. Results: The adverse events were broadly classified into
11 categories. The most common complications were pericardial effusion
(25.3%), stroke (17.7%) and atrio-esophageal 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 (ARF). Discussion: Pericardial
effusion is a common AE reported in patients with convergence procedure
and is well documented in the CONVERGE trial. 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. Lastly, 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 adverse events that are
previously unreported.