ArticleJournal of cardiovascular electrophysiology2022
Adverse events related to AtriCure EPi-Sense Coagulation Device-Analysis of the FDA MAUDE database.
Article in Journal of cardiovascular electrophysiology, 2022. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 1 paper.
What it found
Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.
The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.
Who cites it
1 citing paper in PubMed, 3 citations in OpenAlex.
- Hybrid convergent procedure with proactive oesophageal cooling for the treatment of long-standing persistent atrial fibrillation: a case series.European heart journal. Case reports · 2024Article
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
3 authors at 1 institution in 1 country.
Funding
Abstract
introductionThe 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.
methodsKeyword "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.
resultsThe 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.
conclusionThis analysis of the AE related to the EPi-Sense device highlights several major AE that are previously unreported.
Indexed as
Identifiers
What OpenQuestion holds
Registered trials
Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.