title: Long-term follow-up results of endoscopic treatment of gastroesophageal reflux disease with the MUSE™ endoscopic stapling device.
abstract: The initial 6-month data for MUSE™ (Medigus, Omer, Israel) endoscopic stapling device were reported (Zacherl et al. in Surg Endosc 29:220-229, 2015). The current study aims to evaluate the long-term clinical outcome of 37 patients who received endoscopic gastroesophageal reflux disease (GERD) treatment with the MUSE™ device.
  
  
  
  Efficacy and safety data for 37 patients were analyzed at baseline, 6 months, and 4 years post-procedure. In one center (IU), efficacy and safety data were evaluated at baseline, 6 months post-procedure, and then annually up to 4 years.
  
  
  
  No new complications have been reported in our long-term analysis. The proportions of patients who remained off daily PPI were 83.8 % (31/37) at 6 months and 69.4 % (25/36) at 4 years post-procedure. GERD-Health Related Quality of Life (HRQL) scores (off PPI) were significantly decreased from baseline to 6 months and 4 years post-procedure. The daily dosage of GERD medications, measured as omeprazole equivalents (mean ± SD, mg), decreased from 66.1 ± 33.2 at baseline to 10.8 ± 15.9 at 6 months and 12.8 ± 19.4 at 4 years post-procedure (P < 0.01).
  
  
  
  In our multi-center prospective study, the MUSE™ stapling device appears to be safe and effective in improving symptom scores as well as reducing PPI use in patients with GERD. These results appeared to be equal to or better than those of the other devices for endoluminal GERD therapy. Future studies with larger patient series, sham control group, and greater number of staples are awaited.
authors.affiliation: Department of Internal Medicine, Kangbuk Samsung Hospital, Sungkyunkwan University School of Medicine, Seoul, Korea.
authors.forename: Hong Joo
authors.initials: HJ
authors.lastname: Kim
authors.affiliation: Digestive Disease Center, CHA Bundang Medical Center, CHA University, Seongnam, Korea.
authors.forename: Chang-Il
authors.initials: CI
authors.lastname: Kwon
authors.affiliation: Division of Gastroenterology and Hepatology, Department of Medicine, Indiana University School of Medicine, 550 N University Blvd, UH1634, Indianapolis, IN, 46202, USA.
authors.forename: William R
authors.initials: WR
authors.lastname: Kessler
authors.affiliation: Division of General Surgery, Department of Surgery, Indiana University School of Medicine, Indianapolis, IN, USA.
authors.forename: Don J
authors.initials: DJ
authors.lastname: Selzer
authors.affiliation: Division of Gastroenterology and Hepatology, Department of Medicine, Indiana University School of Medicine, 550 N University Blvd, UH1634, Indianapolis, IN, 46202, USA.
authors.forename: Gail
authors.initials: G
authors.lastname: McNulty
authors.affiliation: Shivanand Desai Center for Digestive Disorders, Deenanath Mangeshkar Hospital and Research Center, Pune, India.
authors.forename: Amol
authors.initials: A
authors.lastname: Bapaye
authors.affiliation: Division of General Surgery, University of Milan Medical School, Milan, Italy.
authors.forename: Luigi
authors.initials: L
authors.lastname: Bonavina
authors.affiliation: Division of Gastroenterology and Hepatology, Department of Medicine, Indiana University School of Medicine, 550 N University Blvd, UH1634, Indianapolis, IN, 46202, USA. glehman@iupui.edu.
authors.forename: Glen A
authors.initials: GA
authors.lastname: Lehman
mesh_terms: D000328:Adult; D004363:Drug Utilization / Q000706:statistics & numerical data; D016099:Endoscopy, Gastrointestinal; D005260:Female; D005500:Follow-Up Studies; D005764:Gastroesophageal Reflux / Q000601:surgery*; D006801:Humans; D008297:Male; D008875:Middle Aged; D009853:Omeprazole / Q000627:therapeutic use; D011446:Prospective Studies; D054328:Proton Pump Inhibitors / Q000627:therapeutic use; D011788:Quality of Life; D013528:Surgical Staplers
chemical_list: D054328:Proton Pump Inhibitors; D009853:Omeprazole
keywords: Endoscopic stapling device; GERD-HRQL; Gastroesophageal reflux disease; MUSE™; Proton pump inhibitor