Case ReportComplications involving the mediastinum after injection of Enteryx for GERD
Section snippets
Case 1
A previously healthy 28-year-old Native American man presented for evaluation of GERD. Pathologic acid reflux was documented by ambulatory pH monitoring, and there was clinical improvement in response to treatment with a proton pump inhibitor (PPI). However, the patient wanted an alternative to pharmacotherapy. Thus, the patient underwent an EGD at which 5 injections (6.6 mL total) of Enteryx were made into the esophageal muscle layers within 1 cm of the gastroesophageal junction (GEJ) by using
Discussion
Both of our patients had mediastinal complications, after esophageal injection of Enteryx, for which hospitalization was required. The first patient was an appropriate candidate for the procedure, because pathologic reflux was documented, he responded to treatment with a PPI, and there was no obvious contraindication. Based on improvement in heartburn with PPI therapy, the second patient also met clinical criteria for Enteryx injection and had no contraindication, although she continued to have
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2015, Surgical Clinics of North AmericaCitation Excerpt :This required multiple, sometimes large-volume injections with fleeting results. Over the years, further attempts were made, but none remain on the market secondary to serious adverse events and/or lack of sustainable clinical efficacy.11–13 These 4 products included
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2014, Clinical Gastroenterology and HepatologyEnsocopic-endoluminal therapies. A critical appraisal
2010, Best Practice and Research: Clinical GastroenterologyCitation Excerpt :However, no difference in pH-metry or LOS pressure data was observed between the 2 groups. If early safety data within the clinical studies were favourable, complications involving the mediastinum were later reported in patients treated outside clinical trials, due to transmural injection or due to nearby inflammatory reaction [53–55]. Due to severe complications after early (possibly too early…) large scale commercialisation, Enteryx was cleared from the market in 2005.
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2007, Gastrointestinal EndoscopyCitation Excerpt :Unrecognized intravascular transmural injection of a tantalum-containing ethylene vinyl alcohol copolymer led to partial embolization of the aorto-esophageal and renal vasculature, and a fatal aortoesophageal fistula in another patient.31 Two cases of severe mediastinal inflammation that involved the pericardium and the pleura occurred, even though the proper procedure was followed.32 However, tantalum was not implicated as the cause of these severe complications, instead, the unrecognized intravascular deposition of the ethylene vinyl alcohol copolymer and its known local inflammatory reaction involving the pleura and the pericardium were the presumed etiologies.30,32