Hybrid Convergent Procedure, Atricure EPi-Sense Device, Adverse
Events, Atrio-Esophageal Fistula, CONVERGE Trial
The Atricure EPi-Sense (EPi-sense) is a recently FDA approved device,
used for the hybrid convergent procedure, an emerging treatment for
persistent atrial fibrillation (AF) and long standing persistent atrial
fibrillation (LSPAF). With the exception of adverse events (AE)
published in the recent CONVERGE trial, there is a paucity of evidence
regarding the AE related to the use of this device. Therefore, the
primary objective of this analysis is to interrogate the post-marketing
surveillance data from the U.S. Food and Drug Administration (FDA)
Manufacturer and User Facility Device Experience (MAUDE) database to
evaluate the complications associated with EPi-sense [1].
We searched for keyword “EPi-SENSE” on the MAUDE database on
01/18/2021. There were 80 reports from 2016-2020. With more than 12,000
convergent procedures performed till date, using the EPi-sense device
(based on personal communication with the device representatives) this
represents an AE rate of less than 1%. The device was returned for
evaluation in 79 reports which were then included in the final analysis.
Although the indications for the EPi-sense were not specified on the
MAUDE database, the manufacturer recommends its use solely for the
hybrid convergent procedure. There was no mention of the type of atrial
fibrillation treated on any device reports.
The AE were broadly classified into 11 categories as seen in table 1.
The three most common categories of AE were: Cardiac and pericardial
injury or inflammation: 27 (34%) events, Embolic: 20 (25%) events, and
esophageal injury: 9 (11%) events. Many of the serious AE such as
atrio-esophageal fistulas (AE-Fistulas), strokes, pericardial effusions,
cardiac perforations and several others preceded the unfortunate event
of death. Therefore, they were included in both categories. The most
common AE was pericardial effusion, reported in 20 (25.3%) reports,
followed by stroke in 14 (17.7%) cases. In contrast to CONVERGE trial
which reported no deaths or AE-fistulas, 19% (15 patients) of cases
reported to MAUDE died and 8.9% (7 patients) developed AE-fistulas.
Pleural effusion was reported in 6 (7.6%) device related AE. 2 events
(2.5%) each of acute renal failure, new onset heart failure, atrial
fibrillation with rapid ventricular response and ventricular
fibrillation were reported. Device malfunction was also reported in 5
(6.4%) of cases, out of which 4 cases were of malfunction of saline
perfusion. One event was reported as system malfunction with no further
details. Transient ischemic attack (TIA) and pulmonary embolism (PE)
were reported in 3 cases each, but no further information on their
anti-coagulation status was provided. 4 events of diaphragmatic, 1
report of incisional and 1 report of pericardial window hernias were
reported.
Pericardial effusion is a common AE reported in patients with
convergence procedure and is well documented in the CONVERGE trial, a
randomized controlled trial comparing the efficacy of hybrid convergent
procedure to conventional catheter ablation in patients with persistent
atrial fibrillation [2]. The CONVERGE trial protocol was therefore
amended to recommend administration of a prophylactic regimen of
steroids or NSAIDS to prevent it. Esophageal injuries are common in
atrial fibrillation procedures involving posterior wall ablation
techniques [3], where the radiofrequency energy is usually directed
towards the esophagus. 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. This should, in theory, reduce the AE-Fistulas and other
esophageal injuries by reducing the number of posteriorly directed
endocardial burns. However, there were reports of saline perfusion
malfunction. As noted by Wats. K et. al. [4], the saline infusion
system in the EPi-Sense device is meant to cool the device, improve
energy penetration and prevent char. The malfunction of this system
could lead to absence of saline infusion to cool the device in certain
cases causing higher chances of injuries due to overheating. The
occurrence of embolic phenomenon reflect interruption of periprocedural
anticoagulation regimen. In-fact, several reports on the MAUDE database
actually mention failure of compliance of anticoagulation regimen.
There are major limitations of using the MAUDE database. One of them is
the underreporting of AE, especially those occurring because of
clinician’s error. This is important in a relatively novel procedure
like the convergent procedure which involves a steep learning curve and
high chances of operator error. In addition, the type of atrial
fibrillation and history of prior ablation procedures in these cases,
which might affect the proportion of AE were unknown. Lastly, there is
no way to determine if these adverse events were related specifically to
the endocardial or the epicardial part of the procedure, a limitation
which also applies to the findings reported in the CONVERGE trial since
no clarification was provided. Nevertheless, our report highlights the
most important adverse events associated with the use of Atricure
EPI-sense device and the need for continued surveillance of safety
profiles, patient outcomes and device failures.
References
- MAUDE. Manufacturer and user facility device experience
[Internet]. Access data.fda.gov. 2020 [cited 30 January 2021].
Available from:
https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/search.cfm.
- DeLurgio DB, Crossen KJ, Gill J, et al. Hybrid Convergent Procedure
for the Treatment of Persistent and Long-Standing Persistent Atrial
Fibrillation: Results of CONVERGE Clinical Trial. Circ Arrhythm
Electrophysiol. 2020;13(12):e009288.\
- Halbfass P, Berkovitz A, Pavlov B, et al. Incidence of acute thermal
esophageal injury after atrial fibrillation ablation guided by
prespecified ablation index. J Cardiovasc Electrophysiol.
2019;30(11):2256-2261.
- Wats K, Kiser A, Makati K, et al. The Convergent Atrial Fibrillation
Ablation Procedure: Evolution of a Multidisciplinary Approach to
Atrial Fibrillation Management. Arrhythm Electrophysiol Rev.
2020;9(2):88-96.
Figure Legend:
Figure 1: Adverse events related to the Atricure EPi-Sense Coagulation
Device. The table shows various different complications associated with
the use of the Atricure EPi-Sense coagulation device. The complications
are grouped into 11 categories. Percentages reflect proportion of the
total AEs reported.