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      Device closure of secundum atrial septal defect's and the risk of cardiac erosion

      review-article
      , BM BS MD FRCP , , MBChB FRCP 1
      Echo Research and Practice
      Bioscientifica Ltd
      atrium, congenital heart defects, congenital heart disease, device closure

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          Abstract

          Cardiac erosion related to transcatheter atrial septal defect closure devices is of increasing concern. Erosion is reported to have occurred with most of currently available occluder devices. Perhaps due to the very large number of implants worldwide, the Amplatzer (St Jude) occluder is associated with the majority of cardiac erosion events reported in the literature. Best current estimates of the incidence of erosion with the St Jude device are between one and three cases per 1000 implants. Most events occur early after implantation and it is rare, although not unheard of, for events to occur after a year following device insertion. It is important that those involved with closure programmes are vigilant for the problem, because device-related erosion is associated with a significant mortality risk. Despite considerable debate, the risk factors (either patient or device) for erosion remain unclear and require further investigation. Currently available data sets have focussed largely on erosion cohorts and are unable to place these cases in appropriate context with non-erosion closure cases. What is certain is that programmes implanting these devices must take care to implant appropriately sized devices and have in place plans to ensure that patients are both well informed and can access help and advice in the event of developing symptoms.

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          Most cited references16

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          Secundum atrial septal defect. Nonoperative closure during cardiac catheterization.

          A 17-year-old girl had clinical and cardiac catheterization findings compatible with a secundum atrial septal defect. During cardiac catheterization, the atrial septal defect was sized and closed using a transvenous umbrella technique.
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            Erosion of Amplatzer septal occluder device after closure of secundum atrial septal defects: review of registry of complications and recommendations to minimize future risk.

            The objectives of this study were to identify possible risk factors that may lead to erosion of the Amplatzer septal occluder (ASO) and recommend ways to minimize future risk. There have been rare occurrences of adverse events with development of pericardial effusion after ASO placement. Identification of high-risk cases, early recognition, and prompt intervention may minimize the future risks of adverse events. In all patients who developed hemodynamic compromise after ASO placement, echocardiograms (pre-, intra-, and postprocedure), atrial septal defect (ASD) size (nonstretched, stretched), size of the device used, cineangiograms, and operative records were reviewed by a panel selected by AGA Medical Corporation. The findings were compared to the premarket approval data obtained from FDA-approved clinical trials that were conducted in the United States, before the device was approved. A total of 28 cases (14 in United States) of adverse events were reported to AGA Medical. All erosions occurred at the dome of the atria, near the aortic root. Deficient aortic rim was seen in 89% and the defect described as high ASD, suggesting deficient superior rim. The device to unstretched ASD ratio was significantly larger in the adverse event group when compared to the FDA trial group. The incidence of device erosion in the United States was 0.1%. The risk of device erosion with ASO is low and complications can be decreased by identifying high-risk patients and following them closely. Patients with deficient aortic rim and/or superior rim may be at higher risk for device erosion. Oversized ASO may increase the risk of erosion. The defect should not be overstretched during balloon sizing. Patients with small pericardial effusion at 24 hr should have closer follow-up. (c) 2004 Wiley-Liss, Inc.
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              Transcatheter device closure of atrial septal defects: a safety review.

              This review discusses the current safety issues related to U.S. Food and Drug Administration approved atrial septal defect devices and proposes a potential avenue to gather additional safety data including factors, which may be involved in device erosion.
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                Author and article information

                Journal
                Echo Res Pract
                Echo Res Pract
                echo
                Echo Res Pract
                Echo Research and Practice
                Bioscientifica Ltd (Bristol )
                2055-0456
                2055-0464
                2 September 2015
                1 December 2015
                : 2
                : 4
                : R73-R78
                Affiliations
                [1]Department of Congenital Cardiology, Leeds General Infirmary , E Floor, Jubilee Wing, Leeds, LS1 3EX, UK
                [1 ]Department of Paediatric Cardiology, Evelina London Childrens Hospital , Westminster Bridge Road, London, SE1 7EH, UK
                Author notes
                Correspondence should be addressed to J D R Thomson Email: thomsonjdr@ 123456mac.com
                Article
                ERP150023
                10.1530/ERP-15-0023
                4676437
                09c290f3-6ff9-4533-9da3-fbe6e3182c83
                © 2015 The authors

                This work is licensed under a Creative Commons Attribution-NonCommercial 4.0 International License.

                History
                : 27 August 2015
                : 2 September 2015
                Categories
                Review

                atrium,congenital heart defects,congenital heart disease,device closure

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