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Magnetic sphincter augmentation and fundoplication for GERD in clinical practice: one-year results of a multicenter, prospective observational study

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Abstract

Background

The techniques available for antireflux surgery have expanded with the introduction of the magnetic sphincter augmentation device (MSAD) for gastroesophageal reflux disease (GERD).

Methods

A prospective, multicenter registry evaluated MSAD and laparoscopic fundoplication (LF) in clinical practice (ClinicalTrials.gov identifier: NCT01624506). Data collection included baseline characteristics, reflux symptoms, proton-pump inhibitor (PPI) use, side effects, and complications. Post-surgical evaluations were collected at one year.

Results

At report, 249 patients (202 MSAD patients and 47 LF patients) had completed one-year follow-up. The LF group was older and had a greater frequency of large hiatal hernias and Barrett’s esophagus than the MSAD group (P < 0.001). The median GERD-health related quality of life score improved from 20.0 to 3.0 after MSAD and 23.0 to 3.5 after LF. Moderate or severe regurgitation improved from 58.2 to 3.1 % after MSAD and 60.0 to 13.0 % after LF (P = 0.014). Discontinuation of PPIs was achieved by 81.8 % of patients after MSAD and 63.0 % after LF (P = 0.009). Excessive gas and abdominal bloating were reported by 10.0 % of patients after MSAD and 31.9 % following LF (P ≤ 0.001). Following MSAD, 91.3 % of patients were able to vomit if needed, compared with 44.4 % of those undergoing LF (P < 0.001). Reoperation rate was 4.0 % following MSAD and 6.4 % following LF.

Conclusion

Antireflux surgery should be individualized to the characteristics of each patient, taking into consideration anatomy and propensity and tolerance of side effects. Both MSAD and LF showed significant improvements in reflux control, with similar safety and reoperation rates. In the treatment continuum of antireflux surgery, MSAD should be considered as a first-line surgical option in appropriately selected patients without Barrett’s esophagus or a large hiatal hernia in order to avoid unnecessary dissection and preserve the patient’s native gastric anatomy. MSAD is an important treatment option and will expand the surgeon’s role in treating GERD.

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Acknowledgments

This work was funded by the Torax Medical, Inc. (ClinicalTrials.gov identifier: NCT01624506).

Disclosures

Drs. Bonavina and Horbach have received consulting fees from Torax Medical. Dr. Schoppmann has received an unrestricted research grant from Torax Medical. Drs. Ashton, Kemen, and Riegler have no conflicts of interest or financial ties to disclose. Torax Medical sponsored and partially funded this study.

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Authors and Affiliations

  1. Department of Surgery, Medical University Vienna, 1090, Vienna, Austria

    Martin Riegler & Sebastian F. Schoppman

  2. Division of General Surgery, Department of Biomedical Sciences for Health, IRCCS Policlinico San Donato, University of Milano Medical School, Milan, Italy

    Luigi Bonavina

  3. The Reflux Centre, London, UK

    David Ashton

  4. Department of Surgery, Municipal Hospital Schwabach, Schwabach, Germany

    Thomas Horbach

  5. Evangelisches Krankenhaus Herne, Akademisches Lehrkrankenhaus der Universität Duisburg-Essen, Herne, Germany

    Matthias Kemen

Authors
  1. Martin Riegler
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  2. Sebastian F. Schoppman
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  3. Luigi Bonavina
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  4. David Ashton
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  5. Thomas Horbach
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  6. Matthias Kemen
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Corresponding author

Correspondence to Martin Riegler.

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Riegler, M., Schoppman, S.F., Bonavina, L. et al. Magnetic sphincter augmentation and fundoplication for GERD in clinical practice: one-year results of a multicenter, prospective observational study. Surg Endosc 29, 1123–1129 (2015). https://doi.org/10.1007/s00464-014-3772-7

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  • DOI: https://doi.org/10.1007/s00464-014-3772-7

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