The patient information used is from the patient demographics provided in the literature article.The gore® helex® septal occluder instructions for use list arrhythmia as a potential device or procedure-related adverse event.Gevorgyan fleming r, kumar p, west b, et al.Comparison of residual shunt rate and complications across 6 different closure devices for patent foramen ovale.Catheter cardiovasc interv.2019;1¿8.Https://doi.Org/10.1002/ccd.28527.
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This information was received through literature article "comparison of residual shunt rate and complications across 6 different closure devices for patent foramen ovale" published in catheterization & cardiovascular interventions, 15 february 2020.In this retrospective study, the efficacy of six different patent foramen ovale (pfo) closure devices used in the united states over an 18-year period, was assessed by measuring the degree of residual shunt after implantation.In addition, the safety of pfo closure was assessed for serious procedure- and device-related adverse events.Indications for pfo closure included cerebral vascular accident, migraine headaches, tia versus complex migraine, myocardial infarction, orthodeoxia, and =1 diagnosis.The article reports 320 patients received quantitative assessment of right-to-left shunting both before and after percutaneous closure from february 2001 to july 2019.The article further reports that 137 patients received a gore® helex® septal occluder.The remaining patients received gore® cardioform septal occluder, amplatzer cribriform, amplatzer aso, cardioseal, and amplatzer pfo devices.Adverse events listed for the gore® helex® septal occluder include 8 cases of arrhythmia.
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