Journal ArticleDOI
Erosion of Amplatzer septal occluder device after closure of secundum atrial septal defects: Review of registry of complications and recommendations to minimize future risk
Zahid Amin,Ziyad M. Hijazi,John L. Bass,John P. Cheatham,William E. Hellenbrand,Charles S. Kleinman +5 more
TLDR
The risk of device erosion with ASO is low and complications can be decreased by identifying high‐risk patients and following them closely, as well as identifying high-risk cases, early recognition, and prompt intervention.Abstract:
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.read more
Citations
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ESC Guidelines for the management of grown-up congenital heart disease (new version 2010).
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TL;DR: Experts in the field are selected and undertake a comprehensive review of the published evidence for management and/or prevention of a given condition, including assessment of the risk–benefit ratio.
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ACC/AHA 2008 guidelines for the management of adults with congenital heart disease: Executive summary - A report of the American College of Cardiology/American Heart Association Task Force on practice guidelines (writing committee to develop guidelines for the management of adults with congenital heart disease)
Carole A. Warnes,Roberta G. Williams,Thomas M. Bashore,John S. Child,Heidi M. Connolly,Joseph A. Dearani,Pedro J. del Nido,James W. Fasules,Thomas P. Graham,Ziyad M. Hijazi,Sharon A. Hunt,Mary Etta King,Michael J. Landzberg,Pamela D. Miner,Martha J. Radford,Edward P. Walsh,Gary D. Webb +16 more
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2018 AHA/ACC Guideline for the Management of Adults With Congenital Heart Disease: A Report of the American College of Cardiology/American Heart Association Task Force on Clinical Practice Guidelines.
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2018 AHA/ACC guideline for the management of adults with congenital heart disease [Clinical Practice Guideline]
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References
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Journal ArticleDOI
Secundum Atrial Septal Defect: Nonoperative Closure During Cardiac Catheterization
TL;DR: A 17-year-old girl had clinical and cardiac catheterization findings compatible with a secundum atrial septal defect that was sized and closed using a transvenous umbrella technique.
Journal ArticleDOI
Comparison of Transcatheter Closure of Secundum Atrial Septal Defect Using the Amplatzer Septal Occluder Associated With Deficient Versus Sufficient Rims
TL;DR: In this paper, the feasibility of transcatheter closure of secundum atrial septal defects associated with small anterior, inferior, or posterior rims is evaluated using an ASO.
Journal ArticleDOI
Late cardiac perforation following transcatheter atrial septal defect closure.
TL;DR: A patient with hemodynamic collapse secondary to cardiac perforation occurring 6-months after the placement of an Amplatzer Septal Occluder is presented and the utilization/complications of this device are discussed.
Journal ArticleDOI
Development of aorta-to-right atrial fistula following closure of secundum atrial septal defect using the Amplatzer septal occluder.
TL;DR: An aorta‐to‐right atrial fistula developed within 3 months after closure of an atrial septal defect using the Amplatzer septalist occluder.
Journal ArticleDOI
Cardiac perforation following transcatheter PFO closure.
Thomas Trepels,Harald E. Zeplin,Horst Sievert,Kai Billinger,Ulrike Krumsdorf,Elisabeth Zadan,Kathrin Horvath +6 more
TL;DR: This work is reporting the first known case of cardiac perforation by an Amplatzer PFO occluder, which has been successfully performed in 102 patients without severe complications.