Adverse events associated with the AtriClip device for left atrial appendage occlusion: A Food and Drug Administration MAUDE database study

Contractor, Tahmeed; Bhardwaj, Rahul; Mandapati, Ravi; Kotak, Kamal; Garg, Jalaj

doi:10.1016/j.hrthm.2022.03.008

Cited by 6 publications

(4 citation statements)

References 4 publications

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“…In one review, in 113 of reported adverse events connected with the use of AtriClip (AtriCure, Inc., Mason, OH, USA), 4 (3.5%) were classified as coronary artery damage, making them the most common in the group of collateral injuries during AtriClip use. 14 In addition, for the Watchman device (Boston Scientific, Marlborough, MA, USA), we found 2 cases of Cx damage and 3 cases of LAA/Cx fistula formation due to device implantation in the US Food and Drug Administration MAUDE database from 2018 to date. There were no reports in this database of Cx damage due to the LARIAT device (SentreHEART, Inc., Pleasanton, CA, USA).…”

Section: Discussionmentioning

confidence: 86%

Left Atrial Appendage Morphology and Course of the Circumflex Artery: Anatomical Implications for Left Atrial Appendage Occlusion Procedures

Batko

Rams

Filip

et al. 2022

Innovations�(Phila)

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Objective: The aim of this study was to evaluate the anatomic topography of the circumflex artery (Cx) and left atrial appendage (LAA) and to determine the safety zones for epicardial LAA closure and LAA occlusion procedures. Methods: The left coronary artery was segmented and visualized from 116 computed tomography angiography scans. Four points were located on the Cx portion periappendicularly, starting from the entry point. The landing zone plane was defined as parallel to the LAA orifice at the level of the beginning of the periappendicular course of the Cx, and the plane of the neck bend was located at the end of the LAA neck. A distance smaller than 2 mm was considered a dangerous distance. Results: The distance between the Cx and the LAA landing zone was 4.3 ± 2 mm. The distance between the Cx and the LAA neck bend was 5.1 ± 2.2 mm. The distance between the Cx and the LAA bottom surface was 5.8 ± 2.9 mm. In 38.8% of patients, at least 1 distance between Cx and LAA was smaller than 2 mm in at least 1 dimension. These distances occurred in 30.2% of the LAA landing zone dimensions, 19.8% of LAA neck bend dimensions, and 11.2% of the LAA bottom surface distances. Conclusions: The study showed that most dangerous distances (30.2%) occurred in the LAA landing zone dimension. The data showed that landing zones more distal from the orifice of the LAA are safer in terms of Cx damage. Therefore, LAA closure should always be performed with caution, to avoid iatrogenic complications.

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Section: Discussionmentioning

confidence: 86%

Left Atrial Appendage Morphology and Course of the Circumflex Artery: Anatomical Implications for Left Atrial Appendage Occlusion Procedures

Batko

Rams

Filip

et al. 2022

Innovations�(Phila)

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“…The AtriClip comprising two parallel titanium tubes with elastic nitinol springs covered with knit-braided polyester ( Figure 4 ) is an option for LAA closure, and coronary occlusion is a potentially fatal complication of this procedure. Contractor et al 3 reported adverse events associated with the AtriClip. During the timeframe of the study, ∼274 000 AtriClips were sold and nearly 41 000 were being deployed thoracoscopically.…”

Section: Discussionmentioning

confidence: 99%

Strategies for managing left main trunk compression by left atrial appendage clip: a case report

Mitsuishi,

Yoshida,

Miura

et al. 2023

European Heart Journal - Case Reports

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Background Closure of the left atrial appendage (LAA) using a clip in at-risk patients reduces stroke risk. The rate of LAA closure procedures is increasing worldwide; however, complications have been reported, with coronary compression being one possible lethal complication associated with the anatomical structures around the LAA. Case summary A 75-year-old man presented with a diagnosis of a φ50 mm saccular thoracic aortic aneurysm. He had a history of chronic atrial fibrillation and functional tricuspid regurgitation. We performed total arch replacement with an open stent graft, tricuspid ring annuloplasty, left atrium Maze procedure, left atrial plication, and LAA closure using a LAA clip. The blood pressure of the patient dropped after closing the pericardium post-operatively. Coronary artery angiography (CAG) confirmed 90% stenosis at the left coronary main trunk (LMT) origin. Percutaneous coronary intervention (PCI) was performed, and the haemodynamics settled. Discussion The distance from the anterior wall of the LAA ostium to the LMT can be a risk for AtriClip-induced LMT compression. A different surgical strategy, such as internal sutures or surgical stapler for LAA closure, should be considered under such a condition. Selecting an appropriately sized AtriClip is essential while using the clip, placing it close to the orifice, and visually checking for compression after insertion to prevent LMT stenosis. When LMT compression by the clip was confirmed, levelling the endocardial adipose tissue with the LAA landing zone, cutting and removing the clip or coronary artery bypass grafting during operation, and PCI during CAG should be considered.

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“…Upon manual review, 135 articles with unclear queries 32–164 and 120 with incomplete queries 165–284 were excluded. Ultimately, 60 executable queries were found 5,10,285–342 . A comprehensive flowchart of this selection process is depicted in Figure 1.…”

Section: Methodsmentioning

confidence: 99%

Assessing the Reproducibility of Research Based on the Food and Drug Administration Manufacturer and User Facility Device Experience Data

Li,

Feng,

Gong

et al. 2024

J Patient Saf

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Objective This article aims to assess the reproducibility of Manufacturer and User Facility Device Experience (MAUDE) data-driven studies by analyzing the data queries used in their research processes. Methods Studies using MAUDE data were sourced from PubMed by searching for “MAUDE” or “Manufacturer and User Facility Device Experience” in titles or abstracts. We manually chose articles with executable queries. The reproducibility of each query was assessed by replicating it in the MAUDE Application Programming Interface. The reproducibility of a query is determined by a reproducibility coefficient that ranges from 0.95 to 1.05. This coefficient is calculated by comparing the number of medical device reports (MDRs) returned by the reproduced queries to the number of reported MDRs in the original studies. We also computed the reproducibility ratio, which is the fraction of reproducible queries in subgroups divided by the query complexity, the device category, and the presence of a data processing flow. Results As of August 8, 2022, we identified 523 articles from which 336 contained queries, and 60 of these were executable. Among these, 14 queries were reproducible. Queries using a single field like product code, product class, or brand name showed higher reproducibility (50%, 33.3%, 31.3%) compared with other fields (8.3%, P = 0.037). Single-category device queries exhibited a higher reproducibility ratio than multicategory ones, but without statistical significance (27.1% versus 8.3%, P = 0.321). Studies including a data processing flow had a higher reproducibility ratio than those without, although this difference was not statistically significant (42.9% versus 17.4%, P = 0.107). Conclusions Our findings indicate that the reproducibility of queries in MAUDE data-driven studies is limited. Enhancing this requires the development of more effective MAUDE data query strategies and improved application programming interfaces.

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Adverse events associated with the AtriClip device for left atrial appendage occlusion: A Food and Drug Administration MAUDE database study

Cited by 6 publications

References 4 publications

Left Atrial Appendage Morphology and Course of the Circumflex Artery: Anatomical Implications for Left Atrial Appendage Occlusion Procedures

Left Atrial Appendage Morphology and Course of the Circumflex Artery: Anatomical Implications for Left Atrial Appendage Occlusion Procedures

Strategies for managing left main trunk compression by left atrial appendage clip: a case report

Assessing the Reproducibility of Research Based on the Food and Drug Administration Manufacturer and User Facility Device Experience Data

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