ArticleJournal of interventional cardiology2020
Comparison of Two Percutaneous Atrial Septal Defect Occluders for Device Healing and Nickel Release in a Chronic Porcine Model.
Article in Journal of interventional cardiology, 2020. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 4 papers.
What it found
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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
4 citing papers in PubMed, 5 citations in OpenAlex.
- Atrial Fibrillation After Patent Foramen Ovale Closure: Incidence, Pathophysiology, and Management.Journal of the American Heart Association · 2024Review
- Role and Applications of Experimental Animal Models of Fontan Circulation.Journal of clinical medicine · 2024Review
- Assessment of Device Neoendothelialization With Cardiac Computed Tomography Angiography After Transcatheter Closure of Atrial Septal Defect.Circulation. Cardiovascular imaging · 2022Article
- Nickel Hypersensitivity to Atrial Septal Occluders: Smoke Without Fire?Clinical reviews in allergy & immunology · 2022Review
Corrections and comments
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Authors and funding
11 authors at 4 institutions in 2 countries.
Funding
No grant is acknowledged in the PubMed record.
Abstract
aimsTo investigate the healing process and nickel release of the Hyperion occluder (Comed BV, Netherlands), as compared to the Amplatzer septal occluder (ASO) (St. Jude Medical Inc., St. Paul, MN, USA) in a chronic swine model.
backgroundSome long-term complications occurring after percutaneous atrial septal defect (ASD) closure may be partially associated with an inappropriate healing of the device and increased nickel release. There is no direct comparative study of different occluders for healing and nickel release.
methodsAfter percutaneous ASD creation, 12 pigs were implanted with 15 mm Hyperion (
resultsImplantation was successful in 100% without complications. Device coverage was observed as early as 1 month after implantation and was almost complete after 3 months. A granulation tissue with a predominantly mononuclear inflammatory reaction was observed in contact with nitinol wires while an inflammatory reaction was seen in contact with textile fibers. We found no statistically significant difference between the 2 devices whether for histological grading scores or systemic nickel release, regardless to follow-up duration.
conclusionsIn this preclinical study, we demonstrated that Amplatzer septal occluder and Hyperion occluder were not significantly different for device healing and nickel release processes.
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Registered trials
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