Endoscopic anterior fundoplication with the Medigus Ultrasonic Surgical Endostapler (MUSE™) for gastroesophageal reflux disease: 6-month results from a multi-center prospective trial

• Published in: Surgical endoscopy Vol. 29; no. 1; pp. 220 - 229
• Main Authors: Zacherl, Johannes, Roy-Shapira, Aviel, Bonavina, Luigi, Bapaye, Amol, Kiesslich, Ralf, Schoppmann, Sebastian F., Kessler, William R., Selzer, Don J., Broderick, Ryan C., Lehman, Glen A., Horgan, Santiago
• Format: Journal Article
• Language: English
• Published: Boston Springer US 01.01.2015; Springer Nature B.V
• Subjects: Abdominal Surgery; Adolescent; Adult; Aged; Combined Modality Therapy; Disease; Drug dosages; Dysphagia; Endoscopy; Endoscopy, Gastrointestinal; Esophageal pH Monitoring; Esophagus; FDA approval; Female; Follow-Up Studies; Fundoplication - instrumentation; Fundoplication - methods; Gastroenterology; Gastroesophageal reflux; Gastroesophageal Reflux - diagnosis; Gastroesophageal Reflux - diagnostic imaging; Gastroesophageal Reflux - drug therapy; Gastroesophageal Reflux - surgery; Gynecology; Hepatology; Humans; Male; Medicine; Medicine & Public Health; Middle Aged; New Technology; Proctology; Prospective Studies; Proton Pump Inhibitors - therapeutic use; Protons; Quality of Life; Surgeons; Surgery; Surgical Staplers; Treatment Outcome; Ultrasonic imaging; Ultrasonography, Interventional; Video-Assisted Surgery; Young Adult; Indiana; United States > US; Indianapolis Indiana; India; Proton pump inhibitors; Nissen fundoplication; Gastroesophageal reflux disease; Anterior fundoplication
• ISSN: 0930-2794; 1432-2218; 1432-2218
• DOI: 10.1007/s00464-014-3731-3

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.