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

Johannes Zacherl, Aviel Roy-Shapira, Luigi Bonavina, Amol Bapaye, Ralf Kiesslich, Sebastian F. Schoppmann, William Kessler, Don Selzer, Ryan C. Broderick, Glen Lehman, Santiago Horgan

Research output: Contribution to journalArticle

38 Citations (Scopus)

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.

Original languageEnglish
Pages (from-to)220-229
Number of pages10
JournalSurgical Endoscopy and Other Interventional Techniques
Volume29
Issue number1
DOIs
StatePublished - Aug 19 2014

Fingerprint

Fundoplication
Gastroesophageal Reflux
Ultrasonics
Proton Pump Inhibitors
Safety
Equipment and Supplies
Surgical Staplers
Quality of Life
Esophageal pH Monitoring
Pharyngitis
Thorax
Prospective Studies
Acids
Wounds and Injuries
Therapeutics

Keywords

  • Anterior fundoplication
  • Gastroesophageal reflux disease
  • Nissen fundoplication
  • Proton pump inhibitors

ASJC Scopus subject areas

  • Surgery

Cite this

Endoscopic anterior fundoplication with the Medigus Ultrasonic Surgical Endostapler (MUSE™) for gastroesophageal reflux disease : 6-month results from a multi-center prospective trial. / Zacherl, Johannes; Roy-Shapira, Aviel; Bonavina, Luigi; Bapaye, Amol; Kiesslich, Ralf; Schoppmann, Sebastian F.; Kessler, William; Selzer, Don; Broderick, Ryan C.; Lehman, Glen; Horgan, Santiago.

In: Surgical Endoscopy and Other Interventional Techniques, Vol. 29, No. 1, 19.08.2014, p. 220-229.

Research output: Contribution to journalArticle

Zacherl, Johannes ; Roy-Shapira, Aviel ; Bonavina, Luigi ; Bapaye, Amol ; Kiesslich, Ralf ; Schoppmann, Sebastian F. ; Kessler, William ; Selzer, Don ; Broderick, Ryan C. ; Lehman, Glen ; Horgan, Santiago. / Endoscopic anterior fundoplication with the Medigus Ultrasonic Surgical Endostapler (MUSE™) for gastroesophageal reflux disease : 6-month results from a multi-center prospective trial. In: Surgical Endoscopy and Other Interventional Techniques. 2014 ; Vol. 29, No. 1. pp. 220-229.
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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.",
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author = "Johannes Zacherl and Aviel Roy-Shapira and Luigi Bonavina and Amol Bapaye and Ralf Kiesslich and Schoppmann, {Sebastian F.} and William Kessler and Don Selzer and Broderick, {Ryan C.} and Glen Lehman and Santiago Horgan",
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AU - Bonavina, Luigi

AU - Bapaye, Amol

AU - Kiesslich, Ralf

AU - Schoppmann, Sebastian F.

AU - Kessler, William

AU - Selzer, Don

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N2 - 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.

AB - 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.

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