Long-Term Follow-Up Results of Endoscopic Treatment of Gastroesophageal Reflux Disease with the MUSE Endoscopic Stapling Device
Long-Term Follow-Up Results of Endoscopic Treatment of Gastroesophageal Reflux Disease with the MUSETM Endoscopic Stapling Device*
Hong Joo Kim1, Chang-Il Kwon2, William R Kessler3, Don J Selzer4, Gail McNulty3, Amol Bapaye5, Luigi Bonavina6, Glen A. Lehman3
1Recent Research Fellow in Indiana University, Department of Internal Medicine, Kangbuk Samsung Hospital, Sungkyunkwan University School of Medicine, Seoul, Korea
2Recent Research Fellow in Indiana University, Digestive Disease Center, CHA Bundang Medical Center, CHA University, Seongnam, Korea
3Division of Gastroenterology and Hepatology, Department of Medicine, Indiana University School of Medicine, Indianapolis, IN, USA
4Division of General Surgery, Department of Surgery, Indiana University School of Medicine, Indianapolis, IN, USA
5Shivanand Desai Center for Digestive Disorders, Deenanath Mangeshkar Hospital & Research Center, Pune, India
6Division of General Surgery, University of Milan Medical School, Milano, Italy
Background The initial 6-month data for MUSETM (Medigus, Omer, Israel) endoscopic stapling device was reported (Zacherl J et al., Surg Endosc 2015;29:220-9). The current study aims to evaluate the long-term clinical outcome of 37 patients who received endoscopic gastroesophageal reflux disease (GERD) treatment with the MUSETM 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 month and 12.8 ± 19.4 at 4 years post-procedure (P <0.01).
Conclusions In our multi-center prospective study, the MUSETM 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.