Esophageal sphincter device for gastroesophageal reflux disease

Robert A. Ganz, Jeffrey H. Peters, Santiago Horgan, Willem A. Bemelman, Christy M. Dunst, Steven A. Edmundowicz, John C. Lipham, James D. Luketich, W. Scott Melvin, Brant K. Oelschlager, Steven C. Schlack-Haerer, C. Daniel Smith, Christopher C. Smith, Dan Dunn, Paul A. Taiganides

Research output: Contribution to journalArticle

146 Scopus citations

Abstract

BACKGROUND: Patients with gastroesophageal reflux disease who have a partial response to proton-pump inhibitors often seek alternative therapy. We evaluated the safety and effectiveness of a new magnetic device to augment the lower esophageal sphincter. METHODS: We prospectively assessed 100 patients with gastroesophageal reflux disease before and after sphincter augmentation. The study did not include a concurrent control group. The primary outcome measure was normalization of esophageal acid exposure or a 50% or greater reduction in exposure at 1 year. Secondary outcomes were 50% or greater improvement in quality of life related to gastroesophageal reflux disease and a 50% or greater reduction in the use of proton-pump inhibitors at 1 year. For each outcome, the prespecified definition of successful treatment was achievement of the outcome in at least 60% of the patients. The 3-year results of a 5-year study are reported. RESULTS: The primary outcome was achieved in 64% of patients (95% confidence interval [CI], 54 to 73). For the secondary outcomes, a reduction of 50% or more in the use of proton-pump inhibitors occurred in 93% of patients, and there was improvement of 50% or more in quality-of-life scores in 92%, as compared with scores for patients assessed at baseline while they were not taking proton-pump inhibitors. The most frequent adverse event was dysphagia (in 68% of patients postoperatively, in 11% at 1 year, and in 4% at 3 years). Serious adverse events occurred in six patients, and in six patients the device was removed. CONCLUSIONS: In this single-group evaluation of 100 patients before and after sphincter augmentation with a magnetic device, exposure to esophageal acid decreased, reflux symptoms improved, and use of proton-pump inhibitors decreased. Follow-up studies are needed to assess long-term safety. (Funded by Torax Medical; ClinicalTrials.gov number, NCT00776997.)

Original languageEnglish (US)
Pages (from-to)719-727
Number of pages9
JournalNew England Journal of Medicine
Volume368
Issue number8
DOIs
StatePublished - Feb 21 2013
Externally publishedYes

ASJC Scopus subject areas

  • Medicine(all)

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    Ganz, R. A., Peters, J. H., Horgan, S., Bemelman, W. A., Dunst, C. M., Edmundowicz, S. A., Lipham, J. C., Luketich, J. D., Melvin, W. S., Oelschlager, B. K., Schlack-Haerer, S. C., Smith, C. D., Smith, C. C., Dunn, D., & Taiganides, P. A. (2013). Esophageal sphincter device for gastroesophageal reflux disease. New England Journal of Medicine, 368(8), 719-727. https://doi.org/10.1056/NEJMoa1205544