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; GERD-HRQL; Gastroesophageal reflux disease; MUSE™; Proton pump inhibitor.

Figures

Fig. 1

The changes in GERD-HRQL off daily PPI scores in A multi-center trial including three sites and B subset of one center (IU) with annual follow-up data

Fig. 2

The proportions of patients who remained off daily PPI in A multi-center trial including three sites and B subset of one center (IU) with annual follow-up data

Fig. 3

The daily dosage of GERD medication, measured as omeprazole equivalents (mg) in A multi-center trial including three sites and B subset of one center (IU) with annual follow-up data

Fig. 4

Both total patients group and IU subset group showed a reduction in acid reflux, as measured by wireless 48-h pH monitoring administered at baseline and 6 months post-procedure. Percent total time pH ≤ 4.0 (mean ± SD) was decreased from baseline to 6 months post-procedure in A total patients group (12.7 ± 13.2 to 7.0 ± 4.7) and B IU subset group (11.2 ± 6.9 to 8.2 ± 4.0). DeMeester scores (mean ± SD) were also decreased from baseline to 6 months post-procedure in C total patients group (49.4 ± 47.2 to 29.1 ± 22.0) and D IU subset group (41.1 ± 22.7 to 32.5 ± 15.2)