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Published in: Surgical Endoscopy 1/2018

01-01-2018

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

Authors: Heather F. Warren, Lisa M. Brown, Matias Mihura, Alexander S. Farivar, Ralph W. Aye, Brian E. Louie

Published in: Surgical Endoscopy | Issue 1/2018

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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.
Literature
2.
go back to reference 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 12:2133–2140CrossRefPubMed 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 12:2133–2140CrossRefPubMed
3.
go back to reference 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 368:719–727CrossRefPubMed 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 368:719–727CrossRefPubMed
4.
go back to reference 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):99–104CrossRefPubMed 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):99–104CrossRefPubMed
5.
go back to reference 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 26:2944–2949CrossRefPubMed 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 26:2944–2949CrossRefPubMed
6.
go back to reference 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 17:577–585CrossRef 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 17:577–585CrossRef
7.
go back to reference 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):305–311CrossRefPubMed 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):305–311CrossRefPubMed
8.
go back to reference 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):787–792CrossRef 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):787–792CrossRef
9.
go back to reference 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):498–504CrossRefPubMed 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):498–504CrossRefPubMed
10.
go back to reference 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 30:3289–3296CrossRefPubMed 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 30:3289–3296CrossRefPubMed
11.
go back to reference 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):123–128CrossRefPubMed 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):123–128CrossRefPubMed
12.
go back to reference 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):2096–2102CrossRefPubMed 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):2096–2102CrossRefPubMed
13.
go back to reference 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 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
14.
go back to reference 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):671–677CrossRefPubMed 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):671–677CrossRefPubMed
15.
go back to reference 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–E317CrossRefPubMedPubMedCentral 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–E317CrossRefPubMedPubMedCentral
16.
go back to reference 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):60–67CrossRefPubMed 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):60–67CrossRefPubMed
17.
go back to reference 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):2113–2120CrossRefPubMed 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):2113–2120CrossRefPubMed
18.
go back to reference 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):292–300CrossRefPubMed 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):292–300CrossRefPubMed
19.
go back to reference Wu JC, Mui LM, Cheung CM, Chan Y, Sung JJ (2007) Obesity is associated with increased transient lower esophageal sphincter relaxation. Gastroenterology 132(3):883–889CrossRefPubMed Wu JC, Mui LM, Cheung CM, Chan Y, Sung JJ (2007) Obesity is associated with increased transient lower esophageal sphincter relaxation. Gastroenterology 132(3):883–889CrossRefPubMed
20.
go back to reference El-Serag HB, Ergun GA, Pandolfino J, Fitzgerald S, Tran T, Kramer JR (2007) Obesity increase oesophageal acid exposure. Gut 56(6):749–755CrossRefPubMed El-Serag HB, Ergun GA, Pandolfino J, Fitzgerald S, Tran T, Kramer JR (2007) Obesity increase oesophageal acid exposure. Gut 56(6):749–755CrossRefPubMed
21.
go back to reference 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):739–743CrossRefPubMed 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):739–743CrossRefPubMed
22.
go back to reference 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):236–243CrossRefPubMed 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):236–243CrossRefPubMed
Metadata
Title
Factors influencing the outcome of magnetic sphincter augmentation for chronic gastroesophageal reflux disease
Authors
Heather F. Warren
Lisa M. Brown
Matias Mihura
Alexander S. Farivar
Ralph W. Aye
Brian E. Louie
Publication date
01-01-2018
Publisher
Springer US
Published in
Surgical Endoscopy / Issue 1/2018
Print ISSN: 0930-2794
Electronic ISSN: 1432-2218
DOI
https://doi.org/10.1007/s00464-017-5696-5

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