Skip to main content
SpringerLink
Log in

Factors influencing the outcome of magnetic sphincter augmentation for chronic gastroesophageal reflux disease

  • Published:
Surgical Endoscopy Aims and scope Submit manuscript

Abstract

Objectives

Magnetic sphincter augmentation (MSA) is a surgical treatment option for patients with gastroesophageal reflux disease (GERD). MSA consistently improves quality of life, maintains freedom from PPIs, and objectively controls GERD. However, up to 24% of patients did not achieve these outcomes. We sought to identify factors predicting outcomes after MSA placement with the aim of refining selection criteria.

Methods

We retrospectively analyzed clinical, endoscopic, manometric, pH data, and intraoperative factors from two databases: Pivotal Trial (N = 99) and our prospectively maintained esophageal database (N = 71). A priori outcomes were defined as excellent (GERD-HRQL <5, no PPI, no esophagitis), good (GERD-HRQL 6–15, no PPI, grade A esophagitis), fair (GERD-HRQL 16 to 25, PPI use, grade B esophagitis), and poor (GERD-HRQL >25, PPI use, grade C/D esophagitis). Univariable and multivariable logistic regression analyses were performed to determine predictors of achieving an excellent/good outcome.

Results

A total of 170 patients underwent MSA with a median age of 53 years, [43–60] and a median BMI of 27 (IQR = 24–30). At baseline, 93.5% of patients experienced typical symptoms and 69% atypical symptoms. Median DeMeester score was 37.9 (IQR 27.9–51.2) with a structurally intact sphincter in 47%. Esophagitis occurred in 43%. At 48 [19–60] months after MSA, excellent outcomes were achieved in 47%, good in 28%, fair in 22%, and poor in 3%. Median DeMeester score was 15.6 (IQR = 5.8–26.6), esophagitis in 17.6% and daily PPI use in 17%. At univariable analysis, excellent/good outcomes were negatively impacted by BMI, preoperative LES residual pressure, Hill grade, and hiatal hernia. At multivariable analysis, BMI >35 (OR = 0.05, 0.003–0.78, p = 0.03), structurally defective LES (OR = 0.37, 0.13–0.99, p = 0.05), and preoperative LES residual pressure (OR = 0.89, 0.80–0.98, p = 0.02) were independent negative predictors of excellent/good outcome.

Conclusions

Magnetic sphincter augmentation results in excellent/good outcomes in most patients but a higher BMI, structurally defective sphincter, and elevated LES residual pressure may prevent this goal.

This is a preview of subscription content, log in via an institution to check access.

Access this article

Log in via an institution

Price excludes VAT (USA)
Tax calculation will be finalised during checkout.

Instant access to the full article PDF.

Institutional subscriptions

Similar content being viewed by others

References

  1. Dent J, El-Serag HB, Wallander MA, Johansson S (2005) Epidemiology of gastroesophageal reflux disease: a systematic review. Gut 54:710–717

    Article  CAS  PubMed  PubMed Central  Google Scholar 

  2. Bonavina L, Saino GI, Bona D, Lipham J, Ganz RA, Dunn D, DeMeester T (2008) Magnetic augmentation of the lower esophageal sphincter: results of a feasibility clinical trial. J Gastrointest Surg 12:2133–2140

    Article  PubMed  Google Scholar 

  3. Ganz RA, Peters JH, Horgan S, Bermelman WA, Dunst CM, Edmondowicz SA, Lipham JC, Lukitich JD, Melvin WS, Oelschlager BK, Schlack-Haerere SC, Smith CD, Smith CC, Dunn D, Taiganides PA (2013) Esophageal sphincter device for gastroesophageal reflux disease. N Engl J Med 368:719–727

    Article  CAS  PubMed  Google Scholar 

  4. Warren HF, Louie BE, Farivar AS, Wilshire C, Aye RW (2017) Manometric changes to the lower esophageal sphincter after magnetic sphincter augmentation in patient with chronic gastroesophageal reflux disease. Ann Surg 266(1):99–104

    Article  PubMed  Google Scholar 

  5. 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 26:2944–2949

    Article  PubMed  Google Scholar 

  6. Bonavina L, Saino G, Bona D, Sironi A, Lazzari V (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 17:577–585

    Article  Google Scholar 

  7. 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 28(4):305–311

    Article  PubMed  Google Scholar 

  8. Saino G, Bonavina L, Lipham JC, 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 Tech 25(10):787–792

    Article  Google Scholar 

  9. Louie BE, Farivar AS, Shultz D, Brennan C, Vallieres E, Aye RW (2014) Short term outcomes using magnetic sphincter augmentation versus nissen fundoplication for medically resistant gastroesophageal reflux disease. Ann Thorac Surg 98(2):498–504

    Article  PubMed  Google Scholar 

  10. Warren HF, Reynolds JL, Lipham JC, Zehetner J, Bildzukewicz NA, Taiganides PA, Mickley J, Aye RW, Farivar AS, Louie BE (2016) Multi institutional outcomes using magnetic sphincter augmentation versus nissen fundoplication for chronic gastroesophageal reflux disease. Surg Endosc 30:3289–3296

    Article  PubMed  Google Scholar 

  11. Reynolds JL, Zehetner J, Wu P, Shah S, Bildzukewicz N, Lipham JC (2015) Laparoscopic magnetic sphincter augmentation vs laparoscopic nissen fundoplication: a matched-pair analysis of 100 patients. J Am Coll Surg 221(1):123–128

    Article  PubMed  Google Scholar 

  12. Rona KA, Reynolds J, Schwameis K, Zehetner J, Samakar K, Oh P, Vong D, Sandhu K, Katkhouda N, Bildzukewicz N, Lipham JC (2017) Efficacy of Magnetic Sphincter Augmentation in Patients with Large Hiatal Hernias. Surg Endosc 31(5):2096–2102

    Article  PubMed  Google Scholar 

  13. Skubleny D, Switzer NJ, Dang J, Gill R, Shi X, Gara C, Birch D, Wong C, Hutter M, Karmali S (2016) LINX magnetic esophageal sphincter augmentation versus nissen fundoplication for gastroesophageal reflux a systematic review and meta analysis. Surg Endosc. doi:10.1007/s00464-016-5370-3

    PubMed  Google Scholar 

  14. Ganz RA, Edmondowicz SA, Taiganides PA, Lipham JC, Smith CD, DeVault KR, Horgan S, Jacobsen G, Luketich JD, Smith CC, Schlack-Haerer SC, Kothari SN, Dunst CM, Watson TJ, Peters J, Oelschlager BK, Perry KA, Melvin S, Bemelman WA, Smout AJ, Dunn D (2016) Long term outcomes of patients receiving a magnetic sphincter augmentation device for gastroesophageal reflux. Clin Gastroenterol Hepatol 14(5):671–677

    Article  PubMed  Google Scholar 

  15. Hansdotter I, Bjor O, Andreasson A, Agreus L, Hellstrom P, Forsberg A, Talley N, Vieth M, Wallner B (2016) Hill classification is superior to the axial length of a hiatal hernia for assessment of the mechanical antireflux barrier at the gastroesophageal junction. Endosc Int Open 4(3):E311–E317

    Article  PubMed  PubMed Central  Google Scholar 

  16. Ayazi S, Lipham J, Portale G, Peyre C, Streets C, Leers J, DeMeester S, Banki F, Chan L, Hagen J, DeMeester T (2009) Bravo Catheter-free pH monitoring: normal values, concordance, optimal diagnostic thresholds, and accuracy. Clin Gastroenterol Hepatol 7(1):60–67

    Article  PubMed  Google Scholar 

  17. Ayazi S, Hagen JA, Zehetner J, Ross O, Wu C, Oezcelik A, Abate E, Sohn HJ, Banki F, Lipham JC, DeMeester S, DeMeester TR (2009) The value of high-resolution manometry in the assessment of the resting characteristics of the lower esophageal sphincter. J Gastrointest Surg 13(12):2113–2120

    Article  PubMed  Google Scholar 

  18. Campos GM, Peters JH, DeMeester TR, Oberg S, Crookes PF, Tan S, DeMeester SR, Hagen JA, Bremner CG (1999) Multivariate analysis of factors predicting outcome after laparoscopic Nissen fundoplication. J Gastrointest Surg 3(3):292–300

    Article  CAS  PubMed  Google Scholar 

  19. Wu JC, Mui LM, Cheung CM, Chan Y, Sung JJ (2007) Obesity is associated with increased transient lower esophageal sphincter relaxation. Gastroenterology 132(3):883–889

    Article  PubMed  Google Scholar 

  20. El-Serag HB, Ergun GA, Pandolfino J, Fitzgerald S, Tran T, Kramer JR (2007) Obesity increase oesophageal acid exposure. Gut 56(6):749–755

    Article  PubMed  Google Scholar 

  21. Quiroga E, Cuenca-Abente F, Flum D, Dellinger EP, Oelschlager BK (2006) Impaired esophageal function in morbidly obese patients with gastroesophageal reflux disease: evaluation with multichannel intraluminal impedance. Surg Endosc 20(5):739–743

    Article  CAS  PubMed  Google Scholar 

  22. Louie BE, Kapur S, Blitz M, Farivar AS, Vallieres E, Aye RW (2013) Length and pressure of the reconstructed lower esophageal sphincter is determined by both crural closure and Nissen fundoplication. J Gastrointest Surg 17(2):236–243

    Article  PubMed  Google Scholar 

Download references

Acknowledgements

Heather F Warren is a previous and Matias Mihura a current fellow of the Advanced Gastrointestinal Surgery Fellowship at Swedish Medical Center, which is supported in part by the Ryan Hill Foundation.

Author information

Authors and Affiliations

  1. Dignity Health, Mercy Medical Center, Redding, CA, USA

    Heather F. Warren

  2. Section of Thoracic Surgery, University of California Davis, Sacramento, CA, USA

    Lisa M. Brown

  3. Division of Thoracic Surgery, Swedish Medical Center and Cancer Institute, 1101 Madison Street Suite 900, Seattle, WA, 98104, USA

    Matias Mihura, Alexander S. Farivar, Ralph W. Aye & Brian E. Louie

Authors
  1. Heather F. Warren
    View author publications

    You can also search for this author in PubMed Google Scholar

  2. Lisa M. Brown
    View author publications

    You can also search for this author in PubMed Google Scholar

  3. Matias Mihura
    View author publications

    You can also search for this author in PubMed Google Scholar

  4. Alexander S. Farivar
    View author publications

    You can also search for this author in PubMed Google Scholar

  5. Ralph W. Aye
    View author publications

    You can also search for this author in PubMed Google Scholar

  6. Brian E. Louie
    View author publications

    You can also search for this author in PubMed Google Scholar

Corresponding author

Correspondence to Brian E. Louie.

Ethics declarations

Disclosures

Louie has received consulting fees and an unrestricted research grant from Torax Medical. Torax Medical provided de-identified data. Warren, Brown, Mihura, Farivar, and Aye have no conflicts of interest or financial ties to disclose.

Rights and permissions

Reprints and permissions

About this article

Check for updates. Verify currency and authenticity via CrossMark

Cite this article

Warren, H.F., Brown, L.M., Mihura, M. et al. Factors influencing the outcome of magnetic sphincter augmentation for chronic gastroesophageal reflux disease. Surg Endosc 32, 405–412 (2018). https://doi.org/10.1007/s00464-017-5696-5

Download citation

  • Received:

  • Accepted:

  • Published:

  • Issue Date:

  • DOI: https://doi.org/10.1007/s00464-017-5696-5

Keywords

Search

Navigation