title: Endoscopic anterior fundoplication with the Medigus Ultrasonic Surgical Endostapler (MUSE™) for gastroesophageal reflux disease: 6-month results from a multi-center prospective trial.
abstract: BACKGROUND
  Both long-term proton pump inhibitor (PPI) use and surgical fundoplication have potential drawbacks as treatments for chronic gastroesophageal reflux disease (GERD). This multi-center, prospective study evaluated the clinical experiences of 69 patients who received an alternative treatment: endoscopic anterior fundoplication with a video- and ultrasound-guided transoral surgical stapler.
  
  
  METHODS
  Patients with well-categorized GERD were enrolled at six international sites. Efficacy data was compared at baseline and at 6 months post-procedure. The primary endpoint was a ≥ 50 % improvement in GERD health-related quality of life (HRQL) score. Secondary endpoints were elimination or ≥ 50 % reduction in dose of PPI medication and reduction of total acid exposure on esophageal pH probe monitoring. A safety evaluation was performed at time 0 and weeks 1, 4, 12, and 6 months.
  
  
  RESULTS
  66 patients completed follow-up. Six months after the procedure, the GERD-HRQL score improved by >50 % off PPI in 73 % (48/66) of patients (95 % CI 60-83 %). Forty-two patients (64.6 %) were no longer using daily PPI medication. Of the 23 patients who continued to take PPI following the procedure, 13 (56.5 %) reported a ≥ 50 % reduction in dose. The mean percent of total time with esophageal pH <4.0 decreased from baseline to 6 months (P < 0.001). Common adverse events were peri-operative chest discomfort and sore throat. Two severe adverse events requiring intervention occurred in the first 24 subjects, no further esophageal injury or leaks were reported in the remaining 48 enrolled subjects.
  
  
  CONCLUSIONS
  The initial 6-month data reported in this study demonstrate safety and efficacy of this endoscopic plication device. Early experience with the device necessitated procedure and device changes to improve safety, with improved results in the later portion of the study. Continued assessment of durability and safety are ongoing in a three-year follow-up study of this patient group.
authors.affiliation: Department of General Surgery, Herz Jesu Krankenhaus, Vienna, Austria, johannes.zacherl@meduniwien.ac.at.
authors.forename: Johannes
authors.initials: J
authors.lastname: Zacherl
authors.forename: Aviel
authors.initials: A
authors.lastname: Roy-Shapira
authors.forename: Luigi
authors.initials: L
authors.lastname: Bonavina
authors.forename: Amol
authors.initials: A
authors.lastname: Bapaye
authors.forename: Ralf
authors.initials: R
authors.lastname: Kiesslich
authors.forename: Sebastian F
authors.initials: SF
authors.lastname: Schoppmann
authors.forename: William R
authors.initials: WR
authors.lastname: Kessler
authors.forename: Don J
authors.initials: DJ
authors.lastname: Selzer
authors.forename: Ryan C
authors.initials: RC
authors.lastname: Broderick
authors.forename: Glen A
authors.initials: GA
authors.lastname: Lehman
authors.forename: Santiago
authors.initials: S
authors.lastname: Horgan
mesh_terms: D000293:Adolescent; D000328:Adult; D000368:Aged; D003131:Combined Modality Therapy; D016099:Endoscopy, Gastrointestinal; D050782:Esophageal pH Monitoring; D005260:Female; D005500:Follow-Up Studies; D018662:Fundoplication / Q000295:instrumentation* / Q000379:methods; D005764:Gastroesophageal Reflux / Q000175:diagnosis / Q000000981:diagnostic imaging / Q000188:drug therapy / Q000601:surgery*; D006801:Humans; D008297:Male; D008875:Middle Aged; D011446:Prospective Studies; D054328:Proton Pump Inhibitors / Q000627:therapeutic use; D011788:Quality of Life; D013528:Surgical Staplers; D016896:Treatment Outcome; D018084:Ultrasonography, Interventional; D020535:Video-Assisted Surgery; D055815:Young Adult
chemical_list: D054328:Proton Pump Inhibitors