Advertisement

Updates in Surgery

, Volume 70, Issue 3, pp 323–330 | Cite as

Magnetic sphincter augmentation for gastroesophageal reflux disease: review of clinical studies

  • Emanuele Asti
  • Alberto Aiolfi
  • Veronica Lazzari
  • Andrea Sironi
  • Matteo Porta
  • Luigi BonavinaEmail author
Review Article

Abstract

Use of the magnetic sphincter augmentation (MSA) device for the laparoscopic treatment of gastroesophageal reflux disease is increasing since the first clinical implant performed a decade ago. The MSA procedure is a minimally invasive and highly standardized surgical option for patients who are partially responders to proton-pump inhibitors, which have troublesome regurgitation or develop progressive symptoms despite continuous medical therapy. The procedure has proven to be highly effective in improving typical reflux symptoms, reducing the use of proton-pump inhibitors, and decreasing esophageal acid exposure. Observational cohort studies have shown that MSA compares well with fundoplication in selected patients and has an acceptable safety profile. The device can be easily removed if necessary, thereby preserving the option of fundoplication in the future. The majority of the removals have occurred within 2 years after implant and have been managed non-emergently, with no complications or long-term consequences. “Expanded” indications to MSA (large hiatal hernia and Barrett’s esophagus) need to be tested in further comparative studies with classic fundoplication procedures.

Keywords

Gastroesophageal reflux disease Lower esophageal sphincter Fundoplication Hiatus hernia Magnetic sphincter augmentation Linx 

Notes

Funding

No funding was received.

Compliance with ethical standards

Conflict of interest

The authors declare that they have no conflict of interest.

Research involving human participants and/or animals

All procedures performed in studies involving human participants were in accordance with the ethical standards of the institutional and/or national research committee and with the 1964 Helsinki declaration and its later amendments or comparable ethical standards.

Informed consent

Informed consent was obtained from all individual participants included in the study.

References

  1. 1.
    Kahrilas PJ, Howden CW, Hughes N (2011) Response of regurgitation to proton pump inhibitor therapy in clinical trials of gastroesophageal reflux disease. Am J Gastroenterol 106:1419–1425CrossRefPubMedGoogle Scholar
  2. 2.
    Del Grande LM, Herbella FA, Bigatao AM et al (2016) Pathophysiology of gastroesophageal reflux in patients with chronic pulmonary obstructive disease is linked to an increased trans diaphragmatic pressure gradient and not to a defective esophagogastric barrier. J Gastrointest Surg 20(1):104–110CrossRefPubMedGoogle Scholar
  3. 3.
    Malfertheiner P, Nocon M, Vieth M et al (2012) Evolution of gastro-oesophageal reflux disease over 5 years under routine medical care—the ProGERD study. Aliment Pharmacol Ther 35:154–164CrossRefPubMedGoogle Scholar
  4. 4.
    Richter JE, Dempsey DT (2008) Laparoscopic antireflux surgery: key to success in the community setting. Am J Gastroenterol 103:289–291CrossRefPubMedGoogle Scholar
  5. 5.
    Khan F, Maradey-Romero C, Ganocy S et al (2016) Utilisation of surgical fundoplication for patients with gastro-oesophageal reflux disease in the USA has declined rapidly between 2009 and 2013. Aliment Pharmacol Ther 43:1124–1131CrossRefPubMedGoogle Scholar
  6. 6.
    Schlottmann F, Strassle PD, Patti MG (2017) Comparative analysis of perioperative outcomes and costs between laparoscopic and open antireflux surgery. J Am Coll Surg 224(3):327–333CrossRefPubMedGoogle Scholar
  7. 7.
    Schlottmann F, Strassle PD, Patti MG (2018) Surgery for benign esophageal disorders in the US: risk factors for complications and trends of morbidity. Surg Endosc.  https://doi.org/10.1007/s00464-018-6102-7 (epub ahead of print) CrossRefPubMedGoogle Scholar
  8. 8.
    Bonavina L, Saino G, Bona D et al (2008) Magnetic augmentation of the lower esophageal sphincter: results of a feasibility clinical trial. J Gastrointest Surg 12:2133–2140CrossRefPubMedGoogle Scholar
  9. 9.
    Bonavina L, DeMeester TR, Fockens P et al (2010) Laparoscopic sphincter augmentation device eliminates reflux symptoms and normalizes esophageal acid exposure. Ann Surg 252:857–862CrossRefPubMedGoogle Scholar
  10. 10.
    Lipham JC, DeMeester TR, Ganz RA et al (2012) The Linx reflux management system: confirmed safety and efficacy now at 4 years. Surg Endosc 26:2944–2949CrossRefPubMedGoogle Scholar
  11. 11.
    Ganz RA, Peters JH, Horgan S et al (2013) Esophageal sphincter device for gastroesophageal reflux disease. N Engl J Med 368:719–727CrossRefPubMedGoogle Scholar
  12. 12.
    Bonavina L, Saino G, Bona D et al (2013) One hundred consecutive patients treated with magnetic sphincter augmentation for gastroesophageal reflux disease: 6 years of clinical experience from a single center. J Am Coll Surg 217:577–585CrossRefPubMedGoogle Scholar
  13. 13.
    Smith CD, Devault KR, Buchanan M (2014) Introduction of mechanical sphincter augmentation for gastroesophageal reflux disease into practice: early clinical outcomes and keys to successful adoption. J Am Coll Surg 218:776–781CrossRefPubMedGoogle Scholar
  14. 14.
    Saino G, Bonavina L, Lipham J, Dunn D, Ganz RA (2015) Magnetic sphincter augmentation for gastroesophageal reflux at 5 years: final results of a pilot study show long-term acid reduction and symptom improvement. J Laparoendosc Adv Surg Technol 25:787–792CrossRefGoogle Scholar
  15. 15.
    Ganz RA, Edmundowicz SA, Taiganides PA et al (2016) Long-term outcomes of patients receiving a magnetic sphincter augmentation device for gastroesophageal reflux. Clin Gastroenterol Hepatol 14(5):671–677CrossRefPubMedGoogle Scholar
  16. 16.
    Louie BE, Farivar AS, Schultz D et al (2014) Short-term outcomes using magnetic sphincter augmentation versus Nissen fundoplication for medically resistant gastroesophageal reflux disease. Ann Thorac Surg 98:498–504CrossRefPubMedGoogle Scholar
  17. 17.
    Reynolds J, Zehetner J, Wu P et al (2015) Laparoscopic magnetic sphincter augmentation vs laparoscopic Nissen fundoplication; a matched-pair analysis of 100 patients. Ann Surg 221:123–128Google Scholar
  18. 18.
    Sheu EG, Nau P, Nath B et al (2015) A comparative trial of laparoscopic magnetic sphincter augmentation and Nissen fundoplication. Surg Endosc 29(3):505–509CrossRefPubMedGoogle Scholar
  19. 19.
    Riegler M, Schoppman SF, Bonavina L et al (2015) Magnetic sphincter augmentation and fundoplication for GERD in clinical practice: one-year results of a multicenter, prospective observational study. Surg Endosc 29:1123–1129CrossRefPubMedGoogle Scholar
  20. 20.
    Warren HF, Reynolds JL, Lipham JC et al (2016) Multi-institutional outcomes using magnetic sphincter augmentation versus Nissen fundoplication for chronic gastroesophageal reflux disease. Surg Endosc 30(8):3289–3296CrossRefPubMedGoogle Scholar
  21. 21.
    Reynolds JL, Zehetner J, Nieh A et al (2016) Charges, outcomes, and complications: a comparison of magnetic sphincter augmentation versus laparoscopic Nissen fundoplication for the treatment of GERD. Surg Endosc 30(8):3225–3230CrossRefPubMedGoogle Scholar
  22. 22.
    Asti E, Bonitta G, Lovece A et al (2016) Longitudinal comparison of quality of life in patients undergoing laparoscopic Toupet fundoplication versus magnetic sphincter augmentation: observational cohort study with propensity score analysis. Medicine (Baltimore) 95(30):e4366CrossRefGoogle Scholar
  23. 23.
    Lipham JC, Taiganides PA, Louie BE et al (2015) Safety analysis of first 1000 patients treated with magnetic sphincter augmentation for gastroesophageal reflux disease. Dis Esophagus 28:305–311CrossRefPubMedGoogle Scholar
  24. 24.
    Smith CD, Ganz RA, Lipham JC et al (2017) Lower esophageal sphincter augmentation for gastroesophageal reflux disease: the safety of a modern implant. J Laparoendosc Adv Surg Technol A 27(6):586–591CrossRefGoogle Scholar
  25. 25.
    Asti E, Siboni S, Lazzari V et al (2017) Removal of the magnetic sphincter device. Surgical technique and results of a single-center cohort study. Ann Surg 265(5):941–945CrossRefPubMedGoogle Scholar
  26. 26.
    Rona KA, Reynolds J, Schwameis K et al (2017) Efficacy of magnetic sphincter augmentation in patients with large hiatal hernias. Surg Endosc 31(5):2096–2102CrossRefPubMedGoogle Scholar
  27. 27.
    Rona KA, Tatum JM, Zehetner J et al (2018) Hiatal hernia recurrence following magnetic sphincter augmentation and posterior cruroplasty: intermediate-term outcomes. Surg Endosc.  https://doi.org/10.1007/s00464-018-6059-6 (epub ahead of print) CrossRefPubMedGoogle Scholar
  28. 28.
    Buckley FP 3rd, Bell RCW, Freeman K et al (2018) Favorable results from a prospective evaluation of 200 patients with large hiatal hernias undergoing LINX magnetic sphincter augmentation. Surg Endosc 32(4):1762–1768CrossRefPubMedGoogle Scholar
  29. 29.
    Kuckelman JP, Phillips CJ, Hardin MO et al (2017) Standard vs expanded indications for esophageal magnetic sphincter augmentation for reflux disease. JAMA Surg 152(9):890–891CrossRefPubMedPubMedCentralGoogle Scholar
  30. 30.
    Aiolfi A, Asti E, Bernardi D et al (2018) Early results of magnetic sphincter augmentation versus fundoplication for gastroesophageal reflux disease: systematic review and meta-analysis. Int J Surg 20(52):82–88CrossRefGoogle Scholar
  31. 31.
    Bell R, Lipham J, Louie BE et al (2017) Randomized controlled trial of magnetic sphincter augmentation (MSA) vs. omeprazole in GERD patients with regurgitation: initial results from the caliber trial. Gastroenterology 152(5 suppl 1):1309CrossRefGoogle Scholar
  32. 32.
    Warren HF, Brown LM, Mihura M et al (2018) Factors influencing the outcome of magnetic sphincter augmentation for chronic gastroesophageal reflux disease. Surg Endosc 32(1):405–412CrossRefPubMedGoogle Scholar

Copyright information

© Italian Society of Surgery (SIC) 2018

Authors and Affiliations

  1. 1.Division of General Surgery, Department of Biomedical Sciences for Health, IRCCS Policlinico San DonatoUniversity of MilanoMilanItaly
  2. 2.Divisione Universitaria di ChirurgiaIRCCS Policlinico San DonatoMilanItaly

Personalised recommendations