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Surgical Endoscopy

, Volume 29, Issue 5, pp 1123–1129 | Cite as

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

  • Martin Riegler
  • Sebastian F. Schoppman
  • Luigi Bonavina
  • David Ashton
  • Thomas Horbach
  • Matthias Kemen
Article

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.

Keywords

Antireflux surgery GERD LINX Fundoplication Regurgitation Proton-pump inhibitors 

Notes

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.

References

  1. 1.
    Savarino V, Di Mario F, Scarpignato C (2009) Proton pump inhibitors in GORD An overview of their pharmacology, efficacy and safety. Pharmacol Res 59:135–153CrossRefPubMedGoogle Scholar
  2. 2.
    Hershcovici T, Fass R (2010) An algorithm for diagnosis and treatment of refractory GERD. Best Pract Res Clin Gastroenterol 24:923–936CrossRefPubMedGoogle Scholar
  3. 3.
    Cheng P, Li JS, Gong J, Zhang LF, Chen RZ (2011) Effects of refluxate pH values on duodenogastroesophageal reflux-induced esophageal adenocarcinoma. World J Gastroenterol 17:3060–3065CrossRefPubMedCentralPubMedGoogle Scholar
  4. 4.
    Gutschow CA, Bludau M, Vallböhmer D, Schröder W, Bollschweiler E, Hölscher AH (2008) Dig Dis Sci 53:3076–3081CrossRefPubMedGoogle Scholar
  5. 5.
    Fohl AL, Regal RE (2011) Proton pump inhibitor-associated pneumonia: Not a breath of fresh air after all? World J Gastrointest Pharmacol Ther 2:17–26CrossRefPubMedCentralPubMedGoogle Scholar
  6. 6.
    Ali T, Roberts DN, Tierney WM (2009) Long-term safety concerns with proton pump inhibitors. Am J Med 122:896–903Google Scholar
  7. 7.
    Spivak H, Lelcuk S, Hunter JG (1999) Laparoscopic surgery of the gastroesophageal junction. World J Surg 23:356–367CrossRefPubMedGoogle Scholar
  8. 8.
    Grant AM, Cotton SC, Boachie C, Ramsay CR, Krukowski ZH, Heading RC, Campbell MK (2013) REFLUX Trial Group. Minimal access surgery compared with medical management for gastro-oesophageal reflux disease: five year follow-up of a randomised controlled trial (REFLUX). BMJ. doi: 10.1136/bmj.f1908
  9. 9.
    Galmiche JP, Hatlebakk J, Attwood S, Ell C, Fiocca R, Eklund S, Långström G, Lind T, Lundell L (2011) Laparoscopic antireflux surgery vs esomeprazole treatment for chronic GERD: the LOTUS randomized clinical trial. JAMA 305:1969–1977CrossRefPubMedGoogle Scholar
  10. 10.
    Katz PO, Zavala S (2010) Proton pump inhibitors in the management of GERD. J Gastrointest Surg 14(Suppl 1):S62–S66CrossRefPubMedGoogle Scholar
  11. 11.
    Castell DO, Kahrilas PJ, Richer JE et al (2002) Esomeprazole (40 mg) compared with lansoprazole (30 mg) in the treatment of erosive esophagitis. Am J Gastroenterol 97:575–583CrossRefPubMedGoogle Scholar
  12. 12.
    Ganz RA, Gostout CJ, Grudem J, Swanson W, Berg T, DeMeester TR (2008) Use of a magnetic sphincter for the treatment of GERD: a feasibility study. Gastrointest Endosc 67:287–294CrossRefPubMedGoogle Scholar
  13. 13.
    Lipham JC, DeMeester TR, Ganz RA, Bonavina L, Saino G, Dunn DH, Fockens P, Bemelman W (2012) The LINX® reflux management system: confirmed safety and efficacy now at 4 years. Surg Endosc 26:2944–2949CrossRefPubMedGoogle Scholar
  14. 14.
    Ganz RA, Peters JH, Horgan S et al (2013) Esophageal sphincter device for gastroesophageal reflux disease. N Engl J Med 368:719–727CrossRefPubMedGoogle Scholar
  15. 15.
    Bonavina L, Saino G, Bona D et al (2013) One hundred consecutive patients treated with magnetic sphincter augmentation for gastroesophageal reflux disease: six years of clinical experience from a single center. J Am Coll Surg 217:577–585CrossRefPubMedGoogle Scholar
  16. 16.
    Lipham JC, Taiganides PA, Louie BE, Ganz RA, DeMeester TR (2014) Safety analysis of first 1000 patients treated with magnetic sphincter augmentation for gastroesophageal reflux disease. Dis Esophagus; epublished March 2014 doi: 10.1111/dote.12199.
  17. 17.
    Velanovich V (2007) The development of the GERD-HRQL symptom severity instrument. Dis Esophagus 20:130–134CrossRefPubMedGoogle Scholar
  18. 18.
    Venkataraman J, Krishnan A (2012) Long-term medical management of gastro-esophageal reflux disease: how long and when to consider surgery? Trop Gastroenterol 33:21–32CrossRefPubMedGoogle Scholar
  19. 19.
    Heidelbaugh JJ, Goldberg KL, Inadomi JM (2010) Magnitude and economic effect of overuse of antisecretory therapy in the ambulatory care setting. Am J Manag Care 16:e228–e234PubMedGoogle Scholar
  20. 20.
    Patti MG, Goldberg HI, Arcerito M, Bortolasi L, Tong J, Way LW (1996) Hiatal hernia size affects lower esophageal sphincter function, esophageal acid exposure, and the degree of mucosal injury. Am J Surg 171:182–186CrossRefPubMedGoogle Scholar
  21. 21.
    Lord RV, DeMeester SR, Peters JH, Hagen JA, Elyssina D, Sheth CT et al (2009) Hiatal Hernia, lower esophageal sphincter incompetence, and effectiveness of nissen fundoplication in the spectrum of gastroesophageal reflux disease. J Gastrointest Surg 13:602–610CrossRefPubMedGoogle Scholar
  22. 22.
    Richter JE (2013) Gastroesophageal reflux disease treatment: side effects and complications of fundoplication. Clin Gastroenterol Hepatol 11:465–471CrossRefPubMedGoogle Scholar

Copyright information

© Springer Science+Business Media New York 2014

Authors and Affiliations

  • Martin Riegler
    • 1
  • Sebastian F. Schoppman
    • 1
  • Luigi Bonavina
    • 2
  • David Ashton
    • 3
  • Thomas Horbach
    • 4
  • Matthias Kemen
    • 5
  1. 1.Department of SurgeryMedical University ViennaViennaAustria
  2. 2.Division of General Surgery, Department of Biomedical Sciences for Health, IRCCS Policlinico San DonatoUniversity of Milano Medical SchoolMilanItaly
  3. 3.The Reflux CentreLondonUK
  4. 4.Department of SurgeryMunicipal Hospital SchwabachSchwabachGermany
  5. 5.Evangelisches Krankenhaus Herne, Akademisches Lehrkrankenhaus der Universität Duisburg-EssenHerneGermany

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