Long-term follow-up results of endoscopic treatment of gastroesophageal reflux disease with the MUSE™ endoscopic stapling device

Hong Joo Kim, Chang Il Kwon, William Kessler, Don Selzer, Gail McNulty, Amol Bapaye, Luigi Bonavina, Glen Lehman

Research output: Contribution to journalArticle

12 Citations (Scopus)

Abstract

Background: 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. Methods: 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. Results: 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). Conclusions: 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.

Original languageEnglish (US)
JournalSurgical Endoscopy and Other Interventional Techniques
DOIs
StateAccepted/In press - Nov 4 2015

Fingerprint

Gastroesophageal Reflux
Equipment and Supplies
Therapeutics
Safety
Omeprazole
Israel
Quality of Life
Prospective Studies
Control Groups

Keywords

  • Endoscopic stapling device
  • Gastroesophageal reflux disease
  • GERD-HRQL
  • MUSE™
  • Proton pump inhibitor

ASJC Scopus subject areas

  • Surgery

Cite this

@article{51466f8946c64b4bab9611256c1f24c5,
title = "Long-term follow-up results of endoscopic treatment of gastroesophageal reflux disease with the MUSE™ endoscopic stapling device",
abstract = "Background: 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. Methods: 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. Results: 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). Conclusions: 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.",
keywords = "Endoscopic stapling device, Gastroesophageal reflux disease, GERD-HRQL, MUSE™, Proton pump inhibitor",
author = "Kim, {Hong Joo} and Kwon, {Chang Il} and William Kessler and Don Selzer and Gail McNulty and Amol Bapaye and Luigi Bonavina and Glen Lehman",
year = "2015",
month = "11",
day = "4",
doi = "10.1007/s00464-015-4622-y",
language = "English (US)",
journal = "Surgical Endoscopy",
issn = "0930-2794",
publisher = "Springer New York",

}

TY - JOUR

T1 - Long-term follow-up results of endoscopic treatment of gastroesophageal reflux disease with the MUSE™ endoscopic stapling device

AU - Kim, Hong Joo

AU - Kwon, Chang Il

AU - Kessler, William

AU - Selzer, Don

AU - McNulty, Gail

AU - Bapaye, Amol

AU - Bonavina, Luigi

AU - Lehman, Glen

PY - 2015/11/4

Y1 - 2015/11/4

N2 - Background: 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. Methods: 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. Results: 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). Conclusions: 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.

AB - Background: 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. Methods: 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. Results: 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). Conclusions: 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.

KW - Endoscopic stapling device

KW - Gastroesophageal reflux disease

KW - GERD-HRQL

KW - MUSE™

KW - Proton pump inhibitor

UR - http://www.scopus.com/inward/record.url?scp=84946147016&partnerID=8YFLogxK

UR - http://www.scopus.com/inward/citedby.url?scp=84946147016&partnerID=8YFLogxK

U2 - 10.1007/s00464-015-4622-y

DO - 10.1007/s00464-015-4622-y

M3 - Article

JO - Surgical Endoscopy

JF - Surgical Endoscopy

SN - 0930-2794

ER -