Increasing Propensity to Pursue Operative Closure of Atrial Septal Defects Following Changes in the Instructions for Use of the Amplatzer Septal Occluder Device: An Observational Study Using Data from the Pediatric Health Information Systems Database

OBJECTIVES: Study trends in the treatment of atrial septal defects (ASD). BACKGROUND: Concern for device erosion following transcatheter treatment of ASD (TC-ASD) led in 2012 to a US FDA panel review and changes in the instructions for use (IFU) of the Amplatzer Septal Occluder (ASO) device. No stud...

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Bibliographic Details
Published in:Am Heart J
Main Authors: O’Byrne, Michael L, Shinohara, Russell T, Grant, Elena K, Kanter, Joshua P, Gillespie, Matthew J, Dori, Yoav, Rome, Jonathan J, Glatz, Andrew C
Format: Artigo
Language:Inglês
Published: 2017
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Article
Online Access:https://ncbi.nlm.nih.gov/pmc/articles/PMC5741186/
https://ncbi.nlm.nih.gov/pubmed/28938967
https://ncbi.nlm.nih.govhttp://dx.doi.org/10.1016/j.ahj.2017.07.012
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