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      Early to Mid-Term Follow-Up Outcomes of Percutaneous Closure of Atrial Septal Defects Using Recent Generation Devices: a Single-Center Experience

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          Abstract

          Background and Objectives

          This study aimed to describe our early to mid-term experience with transcatheter atrial septal defect (ASD) closure using the Occlutech Figulla ® Flex II device (FSO), Gore ® Cardioform septal occluder (GSO), and Amplatzer ® septal occluder (ASO) after they were first approved in Korea in 2014, and to compare the three aforementioned kinds of ASD closure devices.

          Methods

          Between September 2014 and August 2016, 267 patients underwent transcatheter ASD closure in our institution. Baseline characteristics, hemodynamic features, comorbidities, and procedural success and complication rates were analyzed retrospectively. The unpaired Student t-test or variance analysis was used in the statistical analysis.

          Results

          The FSO was most commonly used (n=152, 56.9%), followed by the ASO (n=98, 36.7%) and GSO (n=17, 6.4%). Baseline characteristics and hemodynamic features were similar between the devices, except that the defect size and pulmonary flow-to-systemic flow ratio were lower in the GSO group than in the other groups. Overall, the procedural success rate remained at 100%, and major complication rate was <1%. No late complication occurred during the follow-up.

          Conclusions

          The FSO and GSO are feasible, safe options for use in transcatheter ASD closure, and they are comparable to the ASO.

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          Most cited references23

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          ESC Guidelines for the management of grown-up congenital heart disease (new version 2010).

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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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              Comparison of results and complications of surgical and Amplatzer device closure of atrial septal defects.

              Results and complications of surgical versus transcatheter treatment of atrial septal defect in the current era are compared. All consecutive patients with a secundum atrial septal defect and a pulmonary/systemic flow ratio of 1.5:1 or more who presented between May 1997 and June 1998 were enrolled in this study. All patients except those who initially had defects not feasible for interventional occlusion were catheterized to allow interventional closure of the defects. All patients in whom interventional closure could not be performed underwent surgical closure. Sixty-one patients underwent surgery at a median age of 20 years (0.5-74 years) and 61 had the defect closed with an Amplatzer device (AGA Medical Corporation, Golden Valley, Minn) at a median age of 12 years (0.8-77.7 years) (P >.2). Hospital stay in surgically treated patients was 8 days (6-19 days) versus 3 days (3-14 days) in interventionally treated patients (P <.001). Atrial septal defect and shunt sizes were larger in the surgical group ( P <.001). Closure rates in the 2 groups were identical (98%). One patient (68 years) in the surgical group had a perforated duodenal ulcer that necessitated an operation 8 days after closure of the atrial septal defect, and 1 (26 years) had an infected lateral thoracotomy wound necessitating plastic surgery. Embolization of the Amplatzer device to the left ventricle was observed in 1 patient (29 years). The device could be retrieved from the heart, but vascular surgery was required to extract it from the femoral artery. As complete closure rates and complications are identical, but duration of hospital stay is shorter with less morbidity, we prefer implantation of an Amplatzer septal occluder to surgery wherever possible.
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                Author and article information

                Journal
                Korean Circ J
                Korean Circ J
                KCJ
                Korean Circulation Journal
                The Korean Society of Cardiology
                1738-5520
                1738-5555
                April 2019
                17 December 2018
                : 49
                : 4
                : 326-335
                Affiliations
                [1 ]Division of Pediatric Cardiology, Center for Congenital Heart Disease, Severance Cardiovascular Hospital, Yonsei University College of Medicine, Seoul, Korea.
                [2 ]Department of Biological Basis of Behavior, College of Arts and Sciences, University of Pennsylvania, Philadelphia, PA, USA.
                Author notes
                Correspondence to Jae Young Choi, MD, PhD, SCAI. Division of Pediatric Cardiology, Severance Cardiovascular Hospital, Yonsei University College of Medicine, 50-1, Yonsei-ro, Seodaemun-gu, Seoul 03722, Korea. cjy0122@ 123456yuhs.ac
                Author information
                https://orcid.org/0000-0002-0713-4461
                https://orcid.org/0000-0002-1247-6669
                Article
                10.4070/kcj.2018.0278
                6428945
                30808079
                f847f332-73dd-4d22-b27e-5b7796fb5545
                Copyright © 2019. The Korean Society of Cardiology

                This is an Open Access article distributed under the terms of the Creative Commons Attribution Non-Commercial License ( https://creativecommons.org/licenses/by-nc/4.0) which permits unrestricted noncommercial use, distribution, and reproduction in any medium, provided the original work is properly cited.

                History
                : 16 August 2018
                : 27 November 2018
                Categories
                Original Article

                Cardiovascular Medicine
                congenital heart defects,atrial septal defects,septal occluder device,cardiac catheterization

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