Magnetic augmentation of the lower esophageal sphincter: Results of a feasibility clinical trial

Luigi Bonavina, Greta I. Saino, Davide Bona, John Lipham, Robert A. Ganz, Daniel Dunn, Tom Demeester

Research output: Contribution to journalArticle

Abstract

The high prevalence of gastroesophageal reflux disease continues to encourage the development of treatment modalities to fill the gap between acid-suppression therapy and the laparoscopic Nissen fundoplication. The Magnetic Sphincter Augmentation device has been designed to augment the lower esophageal sphincter barrier using magnetic force. A multi-center feasibility trial was done to evaluate safety and efficacy. Patients with typical heartburn (at least partially responding to proton-pump inhibitors), abnormal esophageal acid exposure, and normal esophageal peristalsis were enrolled. Patients with hiatal hernia >3 cm were excluded from the study. The device was implanted laparoscopically around the distal esophagus. Over a 1-year period, 38 out of 41 enrolled patients underwent this procedure in 3 hospitals. No operative complications were recorded. A free diet was allowed since post-operative day one, and 97% of patients were discharged within 48 h. The mean follow-up was 209 days (range 12-434 days). The GERD-HRQL score decreased from 26.0 to 1.0 (p∈

Original languageEnglish
Pages (from-to)2133-2140
Number of pages8
JournalJournal of Gastrointestinal Surgery
Volume12
Issue number12
DOIs
Publication statusPublished - Dec 2008

Keywords

  • Gastroesophageal reflux disease
  • Laparoscopic Nissen fundoplication
  • Lower esophageal sphincter
  • Phrenoesophageal ligament
  • Proton pump inhibitors

ASJC Scopus subject areas

  • Surgery
  • Gastroenterology

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