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Review Article • ABCD, arq. bras. cir. dig. 36 • 2023 • https://doi.org/10.1590/0102-672020230063e1781   copy

MAGNETIC SPHINCTER AUGMENTATION DEVICE FOR GASTROESOPHAGEAL REFLUX DISEASE: EFFECTIVE, BUT POSTOPERATIVE DYSPHAGIA AND RISK OF EROSION SHOULD NOT BE UNDERESTIMATED. A SYSTEMATIC REVIEW AND META-ANALYSIS

DISPOSITIVO MAGNÉTICO NO ESFINCTER PARA DOENÇA DO REFLUXO GASTROESOFÁGICO: EFICAZ, MAS A DISFAGIA PÓS-OPERATÓRIA E O RISCO DE EROSÃO NÃO DEVEM SER SUBESTIMADOS. UMA REVISÃO SISTEMÁTICA E META-ANÁLISE

Authorship SCIMAGO INSTITUTIONS RANKINGS

ABSTRACT

BACKGROUND:

Magnetic ring (MSA) implantation in the esophagus is an alternative surgical procedure to fundoplication for the treatment of gastroesophageal reflux disease.

AIMS:

The aim of this study was to analyse the effectiveness and safety of magnetic sphincter augmentation (MSA) in patients with gastroesophageal reflux disease (GERD).

METHODS:

A systematic literature review of articles on MSA was performed using the Medical Literature Analysis and Retrieval System Online (Medline) database between 2008 and 2021, following the Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA) guidelines. A random-effect model was used to generate a pooled proportion with 95% confidence interval (CI) across all studies.

RESULTS:

A total of 22 studies comprising 4,663 patients with MSA were analysed. Mean follow-up was 27.3 (7–108) months. The weighted pooled proportion of symptom improvement and patient satisfaction were 93% (95%CI 83–98%) and 85% (95%CI 78–90%), respectively. The mean DeMeester score (pre-MSA: 34.6 vs. post-MSA: 8.9, p=0.03) and GERD-HRQL score (pre-MSA: 25.8 vs. post-MSA: 4.4, p<0.0001) improved significantly after MSA. The proportion of patients taking proton pump inhibitor (PPIs) decreased from 92.8 to 12.4% (p<0.0001). The weighted pooled proportions of dysphagia, endoscopic dilatation and gas-related symptoms were 18, 13, and 3%, respectively. Esophageal erosion occurred in 1% of patients, but its risk significantly increased for every year of MSA use (odds ratio — OR 1.40, 95%CI 1.11–1.77, p=0.004). Device removal was needed in 4% of patients.

CONCLUSIONS:

Although MSA is a very effective treatment modality for GERD, postoperative dysphagia is common and the risk of esophageal erosion increases over time. Further studies are needed to determine the long-term safety of MSA placement in patients with GERD.

HEADINGS:
Gastroesophageal Reflux; Esophagus; Laparoscopy

RESUMO

RACIONAL:

A implantação de anel magnético (AM) no esôfago é um procedimento cirúrgico alternativo à fundoplicatulra, para o tratamento da doença do refluxo gastroesofágico.

OBJETIVOS:

O objetivo deste estudo foi analisar a eficácia e segurança do anel magnético em pacientes com doença do refluxo gastroesofágico (DRGE).

MÉTODOS:

Uma revisão sistemática da literatura de artigos sobre AM foi realizada usando o banco de dados Medline entre 2008 e 2021, seguindo as diretrizes PRISMA. Um modelo de efeito aleatório foi usado para gerar uma proporção agrupada com intervalo de confiança (IC) de 95% em todos os estudos.

RESULTADOS:

Um total de 22 estudos compreendendo 4.663 pacientes submetidos à colocação do AM foram analisados. O seguimento médio foi de 27,3 (7–108) meses. A proporção ponderada de melhora dos sintomas e satisfação do paciente foi de 93% (IC95% 83–98%) e 85% (IC95% 78–90%), respectivamente. A pontuação média de DeMeester (pré-AM: 34,6 versus pós-AM: 8,9, p=0,03) e pontuação GERD-HRQL (pré-AM: 25,8 versus pós-AM: 4,4, p<0,0001) melhoraram significativamente após a colocação do anel. A proporção de pacientes em uso de inbidor de bomba de prótons (IBP) diminuiu de 92,8% para 12,4% (p<0,0001). A erosão esofágica ocorreu em 1% dos pacientes, o risco aumentou significativamente para cada ano de uso do AM (OR 1,40; IC95% 1,11–1,77, p=0,004). A remoção do dispositivo foi necessária em 4% dos pacientes.

CONCLUSÕES:

O AM é uma modalidade de tratamento eficaz para a DRGE. A disfagia pós-operatória é comum, e o risco de erosão esofágica aumenta com o tempo.

DESCRITORES:
Refluxo Gastroesofágico; Doenças do Esôfago; Esôfago

Figure 1
Location of the magnetic sphincter augmentation device.

INTRODUCTION

Gastroesophageal reflux disease (GERD) is a condition which develops when the reflux of stomach contents into the esophagus causes troublesome symptoms or complications5353 Vakil N, van Zanten SV, Kahrilas P, Dent J, Jones R; Global Consensus Group. The Montreal definition and classification of gastroesophageal reflux disease: a global evidence-based consensus. Am J Gastroenterol. 2006;101(8):1900-20; quiz 1943. https://doi.org/10.1111/j.1572-0241.2006.00630.x
https://doi.org/10.1111/j.1572-0241.2006... . GERD is the most prevalent gastrointestinal disorder across the United States, ranging from 6 to 30%, with approximately 110 thousand hospital admissions annually22 Allaix ME, Rebecchi F, Bellocchia A, Morino M, Patti MG. Laparoscopic antireflux surgery: were old questions answered? Partial or total fundoplication? ABCD Arq Bras Cir Dig. 2023;36:e1741. https://doi.org/10.1590/0102-672020230023e1741
https://doi.org/10.1590/0102-67202023002... ,2121 Eusebi LH, Ratnakumaran R, Yuan Y, Solaymani-Dodaran M, Bazzoli F, Ford AC. Global prevalence of, and risk factors for, gastro-oesophageal reflux symptoms: a meta-analysis. Gut. 2018;67(3):430-40. https://doi.org/10.1136/gutjnl-2016-313589
https://doi.org/10.1136/gutjnl-2016-3135... ,5151 Thukkani N, Sonnenberg A. The influence of environmental risk factors in hospitalization for gastro-oesophageal reflux disease-related diagnoses in the United States. Aliment Pharmacol Ther. 2010;31(8):852-61. https://doi.org/10.1111/j.1365-2036.2010.04245.x
https://doi.org/10.1111/j.1365-2036.2010... . Current evidence suggests that its incidence is increasing, mainly due to the rising prevalence of obesity worldwide3535 Luna RA, Peixoto EM, Carvalho CFA, Velasque LS. Impact of body mass index on perioperative outcomes for complex hiatus hernia by videolaparoscopy. Arq Bras Cir Dig. 2022;35:e1672. https://doi.org/10.1590/0102-672020220002e1672
https://doi.org/10.1590/0102-67202022000... . As GERD significantly impairs quality of life and work productivity, it also represents a substantial financial burden to the health-care system2727 Gawron AJ, French DD, Pandolfino JE, Howden CW. Economic evaluations of gastroesophageal reflux disease medical management. Pharmacoeconomics. 2014;32(8):745-58. https://doi.org/10.1007/s40273-014-0164-8
https://doi.org/10.1007/s40273-014-0164-... .

Dietary and lifestyle modifications along with antireflux medication (i.e. proton pump inhibitors [PPI]) are the mainstay of treatment for GERD. However, it is estimated that up to 40% of patients fail to respond to medical therapy1515 Castell DO, Kahrilas PJ, Richter JE, Vakil NB, Johnson DA, Zuckerman S, et al. Esomeprazole (40 mg) compared with lansoprazole (30 mg) in the treatment of erosive esophagitis. Am J Gastroenterol. 2002;97(3):575-83. https://doi.org/10.1111/j.1572-0241.2002.05532.x
https://doi.org/10.1111/j.1572-0241.2002... ,2222 Fass R. Therapeutic options for refractory gastroesophageal reflux disease. J Gastroenterol Hepatol. 2012;27 Suppl 3:3-7. https://doi.org/10.1111/j.1440-1746.2012.07064.x
https://doi.org/10.1111/j.1440-1746.2012... ,3030 Katz PO, Zavala S. Proton pump inhibitors in the management of GERD. J Gastrointest Surg. 2010;14 Suppl 1:S62-6. https://doi.org/10.1007/s11605-009-1015-3
https://doi.org/10.1007/s11605-009-1015-... ,3232 Lipham JC, DeMeester TR, Ganz RA, Bonavina L, Saino G, Dunn DH, et al. The LINX® reflux management system: confirmed safety and efficacy now at 4 years. Surg Endosc. 2012;26(10):2944-9. https://doi.org/10.1007/s00464-012-2289-1
https://doi.org/10.1007/s00464-012-2289-... ,3636 Markar SR, Arhi C, Leusink A, Vidal-Diez A, Karthikesalingam A, Darzi A, et al. The influence of antireflux surgery on esophageal cancer risk in england: national population-based cohort study. Ann Surg. 2018;268(5):861-7. https://doi.org/10.1097/SLA.0000000000002890
https://doi.org/10.1097/SLA.000000000000... . The Society of American Gastrointestinal and Endoscopic Surgeons (SAGES) guidelines on the management of GERD recommend that surgical treatment be considered in individuals who have failed medical therapy, have GERD complications, and/or present extra-esophageal manifestations3939 Patti MG, Herbella FAM. Laparoscopic antireflux surgery: are old questions answered? Useful for extra-esophageal symptoms? Arq Bras Cir Dig. 2022;34(4):e1632. https://doi.org/10.1590/0102-672020210002e1632
https://doi.org/10.1590/0102-67202021000... .

The laparoscopic fundoplication has been the most common surgical procedure to treat GERD in the last decades22 Allaix ME, Rebecchi F, Bellocchia A, Morino M, Patti MG. Laparoscopic antireflux surgery: were old questions answered? Partial or total fundoplication? ABCD Arq Bras Cir Dig. 2023;36:e1741. https://doi.org/10.1590/0102-672020230023e1741
https://doi.org/10.1590/0102-67202023002... ,2424 Fuchs KH, Babic B, Breithaupt W, Dallemagne B, Fingerhut A, Furnee E, et al. EAES recommendations for the management of gastroesophageal reflux disease. Surg Endosc. 2014;28(6):1753-73. https://doi.org/10.1007/s00464-014-3431-z
https://doi.org/10.1007/s00464-014-3431-... ,3737 Martins BC, Souza CS, Ruas JN, Furuya CK, Fylyk SN, Sakai CM et al. Endoscopic evaluation of post-fundoplication anatomy and correlation with symptomatology. Arq Bras Cir Dig. 2021;33(3):e1543. https://doi.org/10.1590/0102-672020200003e1543
https://doi.org/10.1590/0102-67202020000... . In 2008, a multicenter study described a novel laparoscopically implantable magnetic sphincter augmentation (MSA) device designed to restore the lower esophageal sphincter barrier function1313 Bonavina L, Saino GI, Bona D, Lipham J, Ganz RA, Dunn D, et al. Magnetic augmentation of the lower esophageal sphincter: results of a feasibility clinical trial. J Gastrointest Surg. 2008;12(12):2133-40. https://doi.org/10.1007/s11605-008-0698-1
https://doi.org/10.1007/s11605-008-0698-... . It consists in multiple adjustable beads that are placed around the gastroesophageal junction. The magnetic union between each of the beads allows the passage of the swallowed bolus but inhibits the reflux of stomach contents into the esophagus55 Asti E, Siboni S, Lazzari V, Bonitta G, Sironi A, Bonavina L. Removal of the magnetic sphincter augmentation device: surgical technique and results of a single-center cohort study. Ann Surg. 2017;265(5):941-5. https://doi.org/10.1097/SLA.0000000000001785
https://doi.org/10.1097/SLA.000000000000... (Figure 1). Although several studies have demonstrated the safety and efficacy of the device33 Allman R, Speicher J, Rogers A, Ledbetter E, Oliver A, Iannettoni M, et al. Fundic gastropexy for high risk of recurrence laparoscopic hiatal hernia repair and esophageal sphincter augmentation (LINX) improves outcomes without altering perioperative course. Surg Endosc. 2021;35(7):3998-4002. https://doi.org/10.1007/s00464-020-07789-w
https://doi.org/10.1007/s00464-020-07789...

4 Antiporda M, Jackson C, Smith CD, Bowers SP. Short-term outcomes predict long-term satisfaction in patients undergoing laparoscopic magnetic sphincter augmentation. J Laparoendosc Adv Surg Tech A. 2019;29(2):198-202. https://doi.org/10.1089/lap.2018.0598
https://doi.org/10.1089/lap.2018.0598... -55 Asti E, Siboni S, Lazzari V, Bonitta G, Sironi A, Bonavina L. Removal of the magnetic sphincter augmentation device: surgical technique and results of a single-center cohort study. Ann Surg. 2017;265(5):941-5. https://doi.org/10.1097/SLA.0000000000001785
https://doi.org/10.1097/SLA.000000000000... ,77 Ayazi S, Zheng P, Zaidi AH, Chovanec K, Salvitti M, Newhams K, et al. Clinical outcomes and predictors of favorable result after laparoscopic magnetic sphincter augmentation: single-institution experience with more than 500 patients. J Am Coll Surg. 2020;230(5):733-43. https://doi.org/10.1016/j.jamcollsurg.2020.01.026
https://doi.org/10.1016/j.jamcollsurg.20... ,1010 Bonavina L, DeMeester T, Fockens P, Dunn D, Saino G, Bona D, et al. Laparoscopic sphincter augmentation device eliminates reflux symptoms and normalizes esophageal acid exposure: one- and 2-year results of a feasibility trial. Ann Surg. 2010;252(5):857-62. https://doi.org/10.1097/SLA.0b013e3181fd879b
https://doi.org/10.1097/SLA.0b013e3181fd...

11 Bonavina L, Horbach T, Schoppmann SF, DeMarchi J. Three-year clinical experience with magnetic sphincter augmentation and laparoscopic fundoplication. Surg Endosc. 2021;35(7):3449-58. https://doi.org/10.1007/s00464-020-07792-1
https://doi.org/10.1007/s00464-020-07792...

12 Bonavina L, Saino G, Bona D, Sironi A, Lazzari V. 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. 2013;217(4):577-85. https://doi.org/10.1016/j.jamcollsurg.2013.04.039
https://doi.org/10.1016/j.jamcollsurg.20...

13 Bonavina L, Saino GI, Bona D, Lipham J, Ganz RA, Dunn D, et al. Magnetic augmentation of the lower esophageal sphincter: results of a feasibility clinical trial. J Gastrointest Surg. 2008;12(12):2133-40. https://doi.org/10.1007/s11605-008-0698-1
https://doi.org/10.1007/s11605-008-0698-... -1414 Buckley 3rd FP, Bell RCW, Freeman K, Doggett S, Heidrick R. Favorable results from a prospective evaluation of 200 patients with large hiatal hernias undergoing LINX magnetic sphincter augmentation. Surg Endosc. 2018;32(4):1762-8. https://doi.org/10.1007/s00464-017-5859-4
https://doi.org/10.1007/s00464-017-5859-... ,1616 Czosnyka NM, Buckley FP, Doggett SL, Vassaur H, Connolly EE, Borgert AJ, et al. Outcomes of magnetic sphincter augmentation – a community hospital perspective. Am J Surg. 2017;213(6):1019-23. https://doi.org/10.1016/j.amjsurg.2016.09.044
https://doi.org/10.1016/j.amjsurg.2016.0... ,1919 Dominguez-Profeta R, Cheverie JN, Blitzer RR, Lee AM, McClain L, Broderick RC, et al. More beads, more peristaltic reserve, better outcomes: factors predicting postoperative dysphagia after magnetic sphincter augmentation. Surg Endosc. 2021;35(9):5295-302. https://doi.org/10.1007/s00464-020-08013-5
https://doi.org/10.1007/s00464-020-08013... ,2020 Dunn CP, Henning JC, Sterris JA, Won P, Houghton C, Bildzukewicz NA, et al. Regression of Barrett’s esophagus after magnetic sphincter augmentation: intermediate-term results. Surg Endosc. 2021;35(10):5804-9. https://doi.org/10.1007/s00464-020-08074-6
https://doi.org/10.1007/s00464-020-08074... ,2323 Ferrari D, Asti E, Lazzari V, Siboni S, Bernardi D, Bonavina L. Six to 12-year outcomes of magnetic sphincter augmentation for gastroesophageal reflux disease. Sci Rep. 2020;10(1):13753. https://doi.org/10.1038/s41598-020-70742-3
https://doi.org/10.1038/s41598-020-70742... ,2525 Ganz RA, Edmundowicz SA, Taiganides PA, Lipham JC, Smith CD, DeVault KR, et al. Long-term outcomes of patients receiving a magnetic sphincter augmentation device for gastroesophageal reflux. Clin Gastroenterol Hepatol. 2016;14(5):671-7. https://doi.org/10.1016/j.cgh.2015.05.028
https://doi.org/10.1016/j.cgh.2015.05.02... ,2626 Ganz RA, Peters JH, Horgan S. Esophageal sphincter device for gastroesophageal reflux disease. N Engl J Med. 2013;368(21):2039-40. https://doi.org/10.1056/NEJMc1303656
https://doi.org/10.1056/NEJMc1303656... ,2929 Hawasli A, Tarakji M, Tarboush M. Laparoscopic management of severe reflux after sleeve gastrectomy using the LINX® system: technique and one year follow up case report. Int J Surg Case Rep. 2017;30:148-51. https://doi.org/10.1016/j.ijscr.2016.11.050
https://doi.org/10.1016/j.ijscr.2016.11.... ,3232 Lipham JC, DeMeester TR, Ganz RA, Bonavina L, Saino G, Dunn DH, et al. The LINX® reflux management system: confirmed safety and efficacy now at 4 years. Surg Endosc. 2012;26(10):2944-9. https://doi.org/10.1007/s00464-012-2289-1
https://doi.org/10.1007/s00464-012-2289-...

33 Lipham JC, Taiganides PA, Louie BE, Ganz RA, DeMeester TR. Safety analysis of first 1000 patients treated with magnetic sphincter augmentation for gastroesophageal reflux disease. Dis Esophagus. 2015;28(4):305-11. https://doi.org/10.1111/dote.12199
https://doi.org/10.1111/dote.12199... -3434 Louie BE, Smith CD, Smith CC, Bell RCW, Gillian GK, Mandel JS, et al. Objective evidence of reflux control after magnetic sphincter augmentation: one year results from a post approval study. Ann Surg. 2019;270(2):302-8. https://doi.org/10.1097/SLA.0000000000002789
https://doi.org/10.1097/SLA.000000000000... ,4040 Prakash D, Campbell B, Wajed S. Introduction into the NHS of magnetic sphincter augmentation: an innovative surgical therapy for reflux – results and challenges. Ann R Coll Surg Engl. 2018;100(4):251-6. https://doi.org/10.1308/rcsann.2017.0224
https://doi.org/10.1308/rcsann.2017.0224... ,4141 Reynolds JL, Zehetner J, Nieh A, Bildzukewicz N, Sandhu K, Katkhouda N, et al. Charges, outcomes, and complications: a comparison of magnetic sphincter augmentation versus laparoscopic Nissen fundoplication for the treatment of GERD. Surg Endosc. 2016;30(8):3225-30. https://doi.org/10.1007/s00464-015-4635-6
https://doi.org/10.1007/s00464-015-4635-... ,4343 Riva CG, Siboni S, Sozzi M, Lazzari V, Asti E, Bonavina L. High-resolution manometry findings after Linx procedure for gastro-esophageal reflux disease. Neurogastroenterol Motil. 2020;32(3):e13750. https://doi.org/10.1111/nmo.13750
https://doi.org/10.1111/nmo.13750... ,4545 Rona KA, Reynolds J, Schwameis K, Zehetner J, Samakar K, Oh P, et al. Efficacy of magnetic sphincter augmentation in patients with large hiatal hernias. Surg Endosc. 2017;31(5):2096-102. https://doi.org/10.1007/s00464-016-5204-3
https://doi.org/10.1007/s00464-016-5204-... ,4646 Saino G, Bonavina L, Lipham JC, Dunn D, Ganz RA. 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 A. 2015;25(10):787-92. https://doi.org/10.1089/lap.2015.0394
https://doi.org/10.1089/lap.2015.0394... ,4848 Schwameis K, Ayazi S, Zheng P, Grubic AD, Salvitti M, Hoppo T, et al. Efficacy of magnetic sphincter augmentation across the spectrum of gerd disease severity. J Am Coll Surg. 2021;232(3):288-97. https://doi.org/10.1016/j.jamcollsurg.2020.11.012
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49 Sheu EG, Nau P, Nath B, Kuo B, Rattner DW. A comparative trial of laparoscopic magnetic sphincter augmentation and Nissen fundoplication. Surg Endosc. 2015;29(3):505-9. https://doi.org/10.1007/s00464-014-3704-6
https://doi.org/10.1007/s00464-014-3704-... -5050 Tatum JM, Alicuben E, Bildzukewicz N, Samakar K, Houghton CC, Lipham JC. Minimal versus obligatory dissection of the diaphragmatic hiatus during magnetic sphincter augmentation surgery. Surg Endosc. 2019;33(3):782-8. https://doi.org/10.1007/s00464-018-6343-5
https://doi.org/10.1007/s00464-018-6343-... ,5252 Tsai C, Steffen R, Kessler U, Merki H, Lipham J, Zehetner J. Postoperative dysphagia following magnetic sphincter augmentation for gastroesophageal reflux disease. Surg Laparosc Endosc Percutan Tech. 2020;30(4):322-6. https://doi.org/10.1097/SLE.0000000000000785
https://doi.org/10.1097/SLE.000000000000... ,5555 Ward MA, Ebrahim A, Kopita J, Arviso L, Ogola GO, Buckmaster B, et al. Magnetic sphincter augmentation is an effective treatment for atypical symptoms caused by gastroesophageal reflux disease. Surg Endosc. 2020;34(11):4909-15. https://doi.org/10.1007/s00464-019-07278-9
https://doi.org/10.1007/s00464-019-07278... , large series and randomized trials supporting its use are still lacking.

Figure 1
Schematic representation of the magnetic sphincter augmentation device placed around the gastroesophageal junction.

The aim of this systematic review and meta-analysis was to summarize all the currently available evidence on MSA to determine its safety and effectiveness for GERD treatment.

METHODS

Search strategy

A systematic literature review of articles on laparoscopic MSA device placement was performed according to the Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA) guidelines. Medical Literature Analysis and Retrieval System Online (Medline) and Cochrane Central Register of Controlled Trials databases were systematically searched for all articles published from January 2008 to February 2021. The following medical subject headings were used to identify relevant studies: "magnetic sphincter augmentation", "LINX", "Magnetic sphincter augmentation and gastroesophageal reflux disease", "Magnetic sphincter augmentation for GERD". The keywords were used in all possible combinations to obtain the maximal number of articles. The reference list of the retrieved articles was also screened to find articles that were missed during the primary search.

Selection criteria and data extraction

All studies reporting outcomes of patients who underwent MSA device implantation were included in the analysis. The search was limited to articles in English. Experimental studies in animal models, abstracts, case reports, reviews, editorials, and comments were excluded.

A total of 617 articles were initially screened; after removing duplicates and excluding titles and abstracts that did not meet the inclusion criteria, 52 articles were revised by two independent authors (ACV and CAA) based on the methodological quality of the publications. Discrepancies between the two reviewers were resolved by discussion and consensus with the senior author (FS). Finally, 22 articles were included for the meta-analysis1515 Castell DO, Kahrilas PJ, Richter JE, Vakil NB, Johnson DA, Zuckerman S, et al. Esomeprazole (40 mg) compared with lansoprazole (30 mg) in the treatment of erosive esophagitis. Am J Gastroenterol. 2002;97(3):575-83. https://doi.org/10.1111/j.1572-0241.2002.05532.x
https://doi.org/10.1111/j.1572-0241.2002...

16 Czosnyka NM, Buckley FP, Doggett SL, Vassaur H, Connolly EE, Borgert AJ, et al. Outcomes of magnetic sphincter augmentation – a community hospital perspective. Am J Surg. 2017;213(6):1019-23. https://doi.org/10.1016/j.amjsurg.2016.09.044
https://doi.org/10.1016/j.amjsurg.2016.0...

17 Dallemagne B, Weerts J, Markiewicz S, Dewandre JM, Wahlen C, Monami B, et al. Clinical results of laparoscopic fundoplication at ten years after surgery. Surg Endosc. 2006;20(1):159-65. https://doi.org/10.1007/s00464-005-0174-x
https://doi.org/10.1007/s00464-005-0174-...

18 Di Lorenzo N, Lorenzo M, Furbetta F, Favretti F, Giardiello C, Boschi S, et al. Intragastric gastric band migration: erosion: an analysis of multicenter experience on 177 patients. Surg Endosc. 2013;27(4):1151-7. https://doi.org/10.1007/s00464-012-2566-z
https://doi.org/10.1007/s00464-012-2566-...

19 Dominguez-Profeta R, Cheverie JN, Blitzer RR, Lee AM, McClain L, Broderick RC, et al. More beads, more peristaltic reserve, better outcomes: factors predicting postoperative dysphagia after magnetic sphincter augmentation. Surg Endosc. 2021;35(9):5295-302. https://doi.org/10.1007/s00464-020-08013-5
https://doi.org/10.1007/s00464-020-08013...

20 Dunn CP, Henning JC, Sterris JA, Won P, Houghton C, Bildzukewicz NA, et al. Regression of Barrett’s esophagus after magnetic sphincter augmentation: intermediate-term results. Surg Endosc. 2021;35(10):5804-9. https://doi.org/10.1007/s00464-020-08074-6
https://doi.org/10.1007/s00464-020-08074...

21 Eusebi LH, Ratnakumaran R, Yuan Y, Solaymani-Dodaran M, Bazzoli F, Ford AC. Global prevalence of, and risk factors for, gastro-oesophageal reflux symptoms: a meta-analysis. Gut. 2018;67(3):430-40. https://doi.org/10.1136/gutjnl-2016-313589
https://doi.org/10.1136/gutjnl-2016-3135...

22 Fass R. Therapeutic options for refractory gastroesophageal reflux disease. J Gastroenterol Hepatol. 2012;27 Suppl 3:3-7. https://doi.org/10.1111/j.1440-1746.2012.07064.x
https://doi.org/10.1111/j.1440-1746.2012...

23 Ferrari D, Asti E, Lazzari V, Siboni S, Bernardi D, Bonavina L. Six to 12-year outcomes of magnetic sphincter augmentation for gastroesophageal reflux disease. Sci Rep. 2020;10(1):13753. https://doi.org/10.1038/s41598-020-70742-3
https://doi.org/10.1038/s41598-020-70742...

24 Fuchs KH, Babic B, Breithaupt W, Dallemagne B, Fingerhut A, Furnee E, et al. EAES recommendations for the management of gastroesophageal reflux disease. Surg Endosc. 2014;28(6):1753-73. https://doi.org/10.1007/s00464-014-3431-z
https://doi.org/10.1007/s00464-014-3431-...

25 Ganz RA, Edmundowicz SA, Taiganides PA, Lipham JC, Smith CD, DeVault KR, et al. Long-term outcomes of patients receiving a magnetic sphincter augmentation device for gastroesophageal reflux. Clin Gastroenterol Hepatol. 2016;14(5):671-7. https://doi.org/10.1016/j.cgh.2015.05.028
https://doi.org/10.1016/j.cgh.2015.05.02...

26 Ganz RA, Peters JH, Horgan S. Esophageal sphincter device for gastroesophageal reflux disease. N Engl J Med. 2013;368(21):2039-40. https://doi.org/10.1056/NEJMc1303656
https://doi.org/10.1056/NEJMc1303656...

27 Gawron AJ, French DD, Pandolfino JE, Howden CW. Economic evaluations of gastroesophageal reflux disease medical management. Pharmacoeconomics. 2014;32(8):745-58. https://doi.org/10.1007/s40273-014-0164-8
https://doi.org/10.1007/s40273-014-0164-...

28 Guidozzi N, Wiggins T, Ahmed AR, Hanna GB, Markar SR. Laparoscopic magnetic sphincter augmentation versus fundoplication for gastroesophageal reflux disease: systematic review and pooled analysis. Dis Esophagus. 2019;32(9):doz031. https://doi.org/10.1093/dote/doz031
https://doi.org/10.1093/dote/doz031...

29 Hawasli A, Tarakji M, Tarboush M. Laparoscopic management of severe reflux after sleeve gastrectomy using the LINX® system: technique and one year follow up case report. Int J Surg Case Rep. 2017;30:148-51. https://doi.org/10.1016/j.ijscr.2016.11.050
https://doi.org/10.1016/j.ijscr.2016.11....

30 Katz PO, Zavala S. Proton pump inhibitors in the management of GERD. J Gastrointest Surg. 2010;14 Suppl 1:S62-6. https://doi.org/10.1007/s11605-009-1015-3
https://doi.org/10.1007/s11605-009-1015-...

31 Kuckelman JP, Barron MR, Martin MJ. "The missing LINX" for gastroesophageal reflux disease: Operative techniques video for the Linx magnetic sphincter augmentation procedure. Am J Surg. 2017;213(5):984-7. https://doi.org/10.1016/j.amjsurg.2017.03.018
https://doi.org/10.1016/j.amjsurg.2017.0...

32 Lipham JC, DeMeester TR, Ganz RA, Bonavina L, Saino G, Dunn DH, et al. The LINX® reflux management system: confirmed safety and efficacy now at 4 years. Surg Endosc. 2012;26(10):2944-9. https://doi.org/10.1007/s00464-012-2289-1
https://doi.org/10.1007/s00464-012-2289-...

33 Lipham JC, Taiganides PA, Louie BE, Ganz RA, DeMeester TR. Safety analysis of first 1000 patients treated with magnetic sphincter augmentation for gastroesophageal reflux disease. Dis Esophagus. 2015;28(4):305-11. https://doi.org/10.1111/dote.12199
https://doi.org/10.1111/dote.12199...

34 Louie BE, Smith CD, Smith CC, Bell RCW, Gillian GK, Mandel JS, et al. Objective evidence of reflux control after magnetic sphincter augmentation: one year results from a post approval study. Ann Surg. 2019;270(2):302-8. https://doi.org/10.1097/SLA.0000000000002789
https://doi.org/10.1097/SLA.000000000000...

35 Luna RA, Peixoto EM, Carvalho CFA, Velasque LS. Impact of body mass index on perioperative outcomes for complex hiatus hernia by videolaparoscopy. Arq Bras Cir Dig. 2022;35:e1672. https://doi.org/10.1590/0102-672020220002e1672
https://doi.org/10.1590/0102-67202022000... -3636 Markar SR, Arhi C, Leusink A, Vidal-Diez A, Karthikesalingam A, Darzi A, et al. The influence of antireflux surgery on esophageal cancer risk in england: national population-based cohort study. Ann Surg. 2018;268(5):861-7. https://doi.org/10.1097/SLA.0000000000002890
https://doi.org/10.1097/SLA.000000000000... (Table 1 and 2). The investigators (ACV, CAA) independently evaluated and extracted the data from all the eligible publications. The following data were extracted from the articles: author, publication year, design, population size, gender, age, body mass index (BMI), follow-up, preoperative GERD Health-Related Quality of Life (GERD-HRQL) score, preoperative use of proton pump inhibitor (PPI), preoperative DeMeester score, operative time, 30-day overall morbidity, 30-day mortality, length of hospital stay (LOS), symptoms improvement, satisfaction rates, postoperative GERD-HRQL score, postoperative use of PPI, postoperative DeMeester score, dysphagia, endoscopic dilation, gas-related symptoms, erosion, and device removal rates.

Thumbnail
Table 1
Characteristics of studies included in the meta-analysis pre-magnetic sphincter augmentation.
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Table 2
Characteristics of studies included in the meta-analysis post-magnetic sphincter augmentation.

Endpoints

The primary endpoint was effectiveness, which was assessed by symptom improvement, GERD-HRQL score, satisfaction rates, postoperative DeMeester score, and postprocedural use of PPIs. Secondary endpoints included: postoperative dysphagia, need for endoscopic dilation, gas-related symptoms, esophageal erosion, and device removal rates (Figure 2).

Figure 2
Analysis of the articles performed according to the Preferred Reporting Items for Systematic Reviews and Meta-Analysis (PRISMA).

Statistical analysis

The summary statistics were treated as independent observations and analyzed using standard methods for independent data. A meta-analysis of proportions was conducted for the following variables: symptom improvement, satisfaction, dysphagia, endoscopic dilatation, gas-related symptoms, esophageal erosion, and device removal. Statistical heterogeneity was assessed with the I2 statistic, and significance was assumed when the I2 was greater than 50%. Heterogeneity was also defined as a Cochran Q <0.10. As there was evidence of significant heterogeneity across studies, a random-effect model (DerSimonian-Laird method) was used to generate a pooled proportion with 95% confidence interval (CI) across all studies.

Average proportion of patients using PPI, DeMeester Score, and GERD-HRQL score before and after treatment were compared using a paired two-sample t-test. Logistic regression was used to model the effect of the procedure on esophageal erosion while adjusting for length of follow-up. The statistical analysis was performed using R (version 4.0.4) and R Studio (Version 1.4.1106) software. A p<0.05 was considered statistically significant in all the analyses. The study was approved by the Ethics Committee of the Institution (nº 2342346).

RESULTS

A total of 22 studies comprising 4,663 patients with MSA device were included in the analysis. Mean age was 52.6 (39.3–64.3) years, 53% were males, and mean BMI was 27.2 (23.9–29.8) kg/m22 Allaix ME, Rebecchi F, Bellocchia A, Morino M, Patti MG. Laparoscopic antireflux surgery: were old questions answered? Partial or total fundoplication? ABCD Arq Bras Cir Dig. 2023;36:e1741. https://doi.org/10.1590/0102-672020230023e1741
https://doi.org/10.1590/0102-67202023002... . Mean operative time was 62.4 (43.2–81) minutes; 30-day overall morbidity rate was 0.7% and no mortality was reported. Mean LOS was 28.2 (5.2–53) hours. Mean follow-up across the studies was 27.3 (7–108) months. Table 1 and 2 describes the main characteristic of the studies included in the analysis.

The weighted pooled proportion of symptoms improvement was 93% (95% CI, 83–98%) (Figure 3). The heterogeneity χ2 was 0.44 (p<0.01) with an I2 statistic of 85%. The weighted pooled proportion of patient satisfaction was 85% (95%CI 78–90%) (Figure 4). The heterogeneity χ2 was 0.14 (p<0.02) with an inconsistency (I2) statistic of 59%.

Figure 3
The proportion forest plot of symptom improvement.
Figure 4
The proportion of patient satisfaction.

The mean DeMeester score was significantly reduced after MSA device placement (pre-MSA: 34.6 vs. post-MSA: 8.9, p=0,03). The mean GERD-HRQL score significantly improved after the procedure (pre-MSA: 25.8 vs. post-MSA: 4.4, p<0,0001). The proportion of patients taking PPIs decreased from 92.8 to 12.4% after MSA device implantation (p<0,0001).

The weighted pooled proportion of postoperative dysphagia was 18% (95%CI 9–33%) (Figure 5). The heterogeneity chi-squared was 1.9 (p<0.01) with an I2 statistic of 97%. The weighted pooled proportion of patients undergoing endoscopic dilatation was 13% (95%CI 9–19%) (Figure 6). The heterogeneity chi-squared was 0.73 (p<0.01) with an I2 statistic of 92%. The weighted pooled proportion of gas-related symptoms was 3% (95%CI 1–7%). The heterogeneity χ2 was 1.2 (p<0.01) with an I2 statistic of 76%.

Figure 5
The proportion forest plot of postoperative dysphagia.
Figure 6
The proportion forest plot of endoscopic dilation.

The weighted pooled proportion of esophageal erosion was 1% (95%CI 0–2%). The heterogeneity chi-squared was 1.05 (p<0.04) with an I2 statistic of 50%. Follow-up time was found to be significantly associated with the odds of esophageal erosion. It was estimated that the odds of erosion increased by a factor of 1.40 per every year increase in follow-up time (odds ratio — OR 1.40, 95%CI 1.11–1.77, p=0.004). The weighted pooled proportion of patients with device removal was 4% (95%CI 3–6%). The heterogeneity χ2 was 0.31 (p<0.01) with an I2 statistic of 69%.

DISCUSSION

We aimed to determine the effectiveness and safety of the MSA device placement in patients with GERD.

We found that:

  1. the MSA device is very effective as most patients obtain symptom relief and quality of life improvement;

  2. postoperative dysphagia and need for endoscopic dilation are relatively common; and

  3. the risk of esophageal erosion is low but increases significantly over time.

The MSA procedure is currently approved for GERD patients with indication for antireflux surgery, normal esophageal motility, BMI <35 kg/m2, no previous foregut surgery, and hiatal hernia <3 cm3838 Morgenthal CB, Shane MD, Stival A, Gletsu N, Milam G, Swafford V, et al. The durability of laparoscopic Nissen fundoplication: 11-year outcomes. J Gastrointest Surg. 2007;11(6):693-700. https://doi.org/10.1007/s11605-007-0161-8
https://doi.org/10.1007/s11605-007-0161-... . Despite these restricted indications, several studies have determined the effectiveness of the procedure. The pivotal trial, a multi-center study including 100 patients, reported a 90% reduction of GERD symptoms with 86% of patients without PPI use at two years of follow-up33 Allman R, Speicher J, Rogers A, Ledbetter E, Oliver A, Iannettoni M, et al. Fundic gastropexy for high risk of recurrence laparoscopic hiatal hernia repair and esophageal sphincter augmentation (LINX) improves outcomes without altering perioperative course. Surg Endosc. 2021;35(7):3998-4002. https://doi.org/10.1007/s00464-020-07789-w
https://doi.org/10.1007/s00464-020-07789... ,44 Antiporda M, Jackson C, Smith CD, Bowers SP. Short-term outcomes predict long-term satisfaction in patients undergoing laparoscopic magnetic sphincter augmentation. J Laparoendosc Adv Surg Tech A. 2019;29(2):198-202. https://doi.org/10.1089/lap.2018.0598
https://doi.org/10.1089/lap.2018.0598... ,77 Ayazi S, Zheng P, Zaidi AH, Chovanec K, Salvitti M, Newhams K, et al. Clinical outcomes and predictors of favorable result after laparoscopic magnetic sphincter augmentation: single-institution experience with more than 500 patients. J Am Coll Surg. 2020;230(5):733-43. https://doi.org/10.1016/j.jamcollsurg.2020.01.026
https://doi.org/10.1016/j.jamcollsurg.20... ,1010 Bonavina L, DeMeester T, Fockens P, Dunn D, Saino G, Bona D, et al. Laparoscopic sphincter augmentation device eliminates reflux symptoms and normalizes esophageal acid exposure: one- and 2-year results of a feasibility trial. Ann Surg. 2010;252(5):857-62. https://doi.org/10.1097/SLA.0b013e3181fd879b
https://doi.org/10.1097/SLA.0b013e3181fd... ,1111 Bonavina L, Horbach T, Schoppmann SF, DeMarchi J. Three-year clinical experience with magnetic sphincter augmentation and laparoscopic fundoplication. Surg Endosc. 2021;35(7):3449-58. https://doi.org/10.1007/s00464-020-07792-1
https://doi.org/10.1007/s00464-020-07792... ,1414 Buckley 3rd FP, Bell RCW, Freeman K, Doggett S, Heidrick R. Favorable results from a prospective evaluation of 200 patients with large hiatal hernias undergoing LINX magnetic sphincter augmentation. Surg Endosc. 2018;32(4):1762-8. https://doi.org/10.1007/s00464-017-5859-4
https://doi.org/10.1007/s00464-017-5859-... ,1616 Czosnyka NM, Buckley FP, Doggett SL, Vassaur H, Connolly EE, Borgert AJ, et al. Outcomes of magnetic sphincter augmentation – a community hospital perspective. Am J Surg. 2017;213(6):1019-23. https://doi.org/10.1016/j.amjsurg.2016.09.044
https://doi.org/10.1016/j.amjsurg.2016.0... ,1919 Dominguez-Profeta R, Cheverie JN, Blitzer RR, Lee AM, McClain L, Broderick RC, et al. More beads, more peristaltic reserve, better outcomes: factors predicting postoperative dysphagia after magnetic sphincter augmentation. Surg Endosc. 2021;35(9):5295-302. https://doi.org/10.1007/s00464-020-08013-5
https://doi.org/10.1007/s00464-020-08013... ,2020 Dunn CP, Henning JC, Sterris JA, Won P, Houghton C, Bildzukewicz NA, et al. Regression of Barrett’s esophagus after magnetic sphincter augmentation: intermediate-term results. Surg Endosc. 2021;35(10):5804-9. https://doi.org/10.1007/s00464-020-08074-6
https://doi.org/10.1007/s00464-020-08074... ,2323 Ferrari D, Asti E, Lazzari V, Siboni S, Bernardi D, Bonavina L. Six to 12-year outcomes of magnetic sphincter augmentation for gastroesophageal reflux disease. Sci Rep. 2020;10(1):13753. https://doi.org/10.1038/s41598-020-70742-3
https://doi.org/10.1038/s41598-020-70742... ,2525 Ganz RA, Edmundowicz SA, Taiganides PA, Lipham JC, Smith CD, DeVault KR, et al. Long-term outcomes of patients receiving a magnetic sphincter augmentation device for gastroesophageal reflux. Clin Gastroenterol Hepatol. 2016;14(5):671-7. https://doi.org/10.1016/j.cgh.2015.05.028
https://doi.org/10.1016/j.cgh.2015.05.02... ,2626 Ganz RA, Peters JH, Horgan S. Esophageal sphincter device for gastroesophageal reflux disease. N Engl J Med. 2013;368(21):2039-40. https://doi.org/10.1056/NEJMc1303656
https://doi.org/10.1056/NEJMc1303656... ,3434 Louie BE, Smith CD, Smith CC, Bell RCW, Gillian GK, Mandel JS, et al. Objective evidence of reflux control after magnetic sphincter augmentation: one year results from a post approval study. Ann Surg. 2019;270(2):302-8. https://doi.org/10.1097/SLA.0000000000002789
https://doi.org/10.1097/SLA.000000000000... ,4040 Prakash D, Campbell B, Wajed S. Introduction into the NHS of magnetic sphincter augmentation: an innovative surgical therapy for reflux – results and challenges. Ann R Coll Surg Engl. 2018;100(4):251-6. https://doi.org/10.1308/rcsann.2017.0224
https://doi.org/10.1308/rcsann.2017.0224... ,4141 Reynolds JL, Zehetner J, Nieh A, Bildzukewicz N, Sandhu K, Katkhouda N, et al. Charges, outcomes, and complications: a comparison of magnetic sphincter augmentation versus laparoscopic Nissen fundoplication for the treatment of GERD. Surg Endosc. 2016;30(8):3225-30. https://doi.org/10.1007/s00464-015-4635-6
https://doi.org/10.1007/s00464-015-4635-... ,4343 Riva CG, Siboni S, Sozzi M, Lazzari V, Asti E, Bonavina L. High-resolution manometry findings after Linx procedure for gastro-esophageal reflux disease. Neurogastroenterol Motil. 2020;32(3):e13750. https://doi.org/10.1111/nmo.13750
https://doi.org/10.1111/nmo.13750... ,4545 Rona KA, Reynolds J, Schwameis K, Zehetner J, Samakar K, Oh P, et al. Efficacy of magnetic sphincter augmentation in patients with large hiatal hernias. Surg Endosc. 2017;31(5):2096-102. https://doi.org/10.1007/s00464-016-5204-3
https://doi.org/10.1007/s00464-016-5204-... ,4848 Schwameis K, Ayazi S, Zheng P, Grubic AD, Salvitti M, Hoppo T, et al. Efficacy of magnetic sphincter augmentation across the spectrum of gerd disease severity. J Am Coll Surg. 2021;232(3):288-97. https://doi.org/10.1016/j.jamcollsurg.2020.11.012
https://doi.org/10.1016/j.jamcollsurg.20... ,5050 Tatum JM, Alicuben E, Bildzukewicz N, Samakar K, Houghton CC, Lipham JC. Minimal versus obligatory dissection of the diaphragmatic hiatus during magnetic sphincter augmentation surgery. Surg Endosc. 2019;33(3):782-8. https://doi.org/10.1007/s00464-018-6343-5
https://doi.org/10.1007/s00464-018-6343-... ,5252 Tsai C, Steffen R, Kessler U, Merki H, Lipham J, Zehetner J. Postoperative dysphagia following magnetic sphincter augmentation for gastroesophageal reflux disease. Surg Laparosc Endosc Percutan Tech. 2020;30(4):322-6. https://doi.org/10.1097/SLE.0000000000000785
https://doi.org/10.1097/SLE.000000000000... ,5555 Ward MA, Ebrahim A, Kopita J, Arviso L, Ogola GO, Buckmaster B, et al. Magnetic sphincter augmentation is an effective treatment for atypical symptoms caused by gastroesophageal reflux disease. Surg Endosc. 2020;34(11):4909-15. https://doi.org/10.1007/s00464-019-07278-9
https://doi.org/10.1007/s00464-019-07278... . Similarly, a recent study including 553 patients showed that 84% of patients had at least 50% improvement in the GERD-HRQL score at a median follow-up of 10.6 months. Although our pooled analysis had a relatively short mean follow-up (27.3 months), our findings confirmed that most patients undergoing MSA implantation achieve a substantial improvement in GERD symptoms (93%) and are satisfied with the results (85%). Unfortunately, few studies showed objective data for assessment of postoperative results. DeMeester scores, however, significantly decreased in those studied with pH monitoring. In addition, few patients required PPIs after MSA implantation (12.4 %).

Dysphagia is a possible side effect of the procedure and represents one of the main indications for the MSA device removal. A previous study reported a dysphagia rate of 15.5% among 380 patients undergoing MSA placement with an overall response to the endoscopic dilatation of 68%. Only 1.8% of patients with dysphagia required device removal66 Ayazi S, Zheng P, Zaidi AH, Chovanec K, Chowdhury N, Salvitti M, et al. Magnetic sphincter augmentation and postoperative dysphagia: characterization, clinical risk factors, and management. J Gastrointest Surg. 2020;24(1):39-49. https://doi.org/10.1007/s11605-019-04331-9
https://doi.org/10.1007/s11605-019-04331... . Another study found that the most common reason for removal was symptom recurrence (46%), followed by dysphagia (37%), and chest pain (18%)55 Asti E, Siboni S, Lazzari V, Bonitta G, Sironi A, Bonavina L. Removal of the magnetic sphincter augmentation device: surgical technique and results of a single-center cohort study. Ann Surg. 2017;265(5):941-5. https://doi.org/10.1097/SLA.0000000000001785
https://doi.org/10.1097/SLA.000000000000... . Our pooled analysis confirmed that the MSA procedure is associated with a relatively high incidence of postoperative dysphagia (18%), and a non-negligible proportion of patients (13%) required at least one endoscopic dilation.

Esophageal erosion and perforation are the main concerns after MSA device placement. In fact, "similar" type of devices such as the Angelchick prosthesis for GERD and the adjustable gastric band for obesity have been associated with these serious complications66 Ayazi S, Zheng P, Zaidi AH, Chovanec K, Chowdhury N, Salvitti M, et al. Magnetic sphincter augmentation and postoperative dysphagia: characterization, clinical risk factors, and management. J Gastrointest Surg. 2020;24(1):39-49. https://doi.org/10.1007/s11605-019-04331-9
https://doi.org/10.1007/s11605-019-04331... ,5454 Varshney S, Kelly JJ, Branagan G, Somers SS, Kelly JM. Angelchik prosthesis revisited. World J Surg. 2002;26(1):129-33. https://doi.org/10.1007/s00268-001-0192-3
https://doi.org/10.1007/s00268-001-0192-... . Salvador et al. reported two cases of severe dysphagia after MSA procedure due to migration of the device into the esophagus. The devices were safely removed endoscopically in a single step in both cases4747 Salvador R, Costantini M, Capovilla G, Polese L, Merigliano S. Esophageal penetration of the magnetic sphincter augmentation device: history repeats itself. J Laparoendosc Adv Surg Tech A. 2017;27(8):834-8. https://doi.org/10.1089/lap.2017.0182
https://doi.org/10.1089/lap.2017.0182... . In agreement, Bona et al. concluded in 2021 that MSA devices can be safely explanted via a single-stage laparoscopic procedure associated with common antireflux procedures99 Bona D, Saino G, Mini E, Lombardo F, Panizzo V, Cavalli M, et al. Magnetic sphincter augmentation device removal: surgical technique and results at medium-term follow-up. Langenbecks Arch Surg. 2021;406(7):2545-51. https://doi.org/10.1007/s00423-021-02294-7
https://doi.org/10.1007/s00423-021-02294... . However, the MSA device has proven to be safe among most published studies33 Allman R, Speicher J, Rogers A, Ledbetter E, Oliver A, Iannettoni M, et al. Fundic gastropexy for high risk of recurrence laparoscopic hiatal hernia repair and esophageal sphincter augmentation (LINX) improves outcomes without altering perioperative course. Surg Endosc. 2021;35(7):3998-4002. https://doi.org/10.1007/s00464-020-07789-w
https://doi.org/10.1007/s00464-020-07789...

4 Antiporda M, Jackson C, Smith CD, Bowers SP. Short-term outcomes predict long-term satisfaction in patients undergoing laparoscopic magnetic sphincter augmentation. J Laparoendosc Adv Surg Tech A. 2019;29(2):198-202. https://doi.org/10.1089/lap.2018.0598
https://doi.org/10.1089/lap.2018.0598... -55 Asti E, Siboni S, Lazzari V, Bonitta G, Sironi A, Bonavina L. Removal of the magnetic sphincter augmentation device: surgical technique and results of a single-center cohort study. Ann Surg. 2017;265(5):941-5. https://doi.org/10.1097/SLA.0000000000001785
https://doi.org/10.1097/SLA.000000000000... ,77 Ayazi S, Zheng P, Zaidi AH, Chovanec K, Salvitti M, Newhams K, et al. Clinical outcomes and predictors of favorable result after laparoscopic magnetic sphincter augmentation: single-institution experience with more than 500 patients. J Am Coll Surg. 2020;230(5):733-43. https://doi.org/10.1016/j.jamcollsurg.2020.01.026
https://doi.org/10.1016/j.jamcollsurg.20... ,1010 Bonavina L, DeMeester T, Fockens P, Dunn D, Saino G, Bona D, et al. Laparoscopic sphincter augmentation device eliminates reflux symptoms and normalizes esophageal acid exposure: one- and 2-year results of a feasibility trial. Ann Surg. 2010;252(5):857-62. https://doi.org/10.1097/SLA.0b013e3181fd879b
https://doi.org/10.1097/SLA.0b013e3181fd...

11 Bonavina L, Horbach T, Schoppmann SF, DeMarchi J. Three-year clinical experience with magnetic sphincter augmentation and laparoscopic fundoplication. Surg Endosc. 2021;35(7):3449-58. https://doi.org/10.1007/s00464-020-07792-1
https://doi.org/10.1007/s00464-020-07792...

12 Bonavina L, Saino G, Bona D, Sironi A, Lazzari V. 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. 2013;217(4):577-85. https://doi.org/10.1016/j.jamcollsurg.2013.04.039
https://doi.org/10.1016/j.jamcollsurg.20...

13 Bonavina L, Saino GI, Bona D, Lipham J, Ganz RA, Dunn D, et al. Magnetic augmentation of the lower esophageal sphincter: results of a feasibility clinical trial. J Gastrointest Surg. 2008;12(12):2133-40. https://doi.org/10.1007/s11605-008-0698-1
https://doi.org/10.1007/s11605-008-0698-... -1414 Buckley 3rd FP, Bell RCW, Freeman K, Doggett S, Heidrick R. Favorable results from a prospective evaluation of 200 patients with large hiatal hernias undergoing LINX magnetic sphincter augmentation. Surg Endosc. 2018;32(4):1762-8. https://doi.org/10.1007/s00464-017-5859-4
https://doi.org/10.1007/s00464-017-5859-... ,1616 Czosnyka NM, Buckley FP, Doggett SL, Vassaur H, Connolly EE, Borgert AJ, et al. Outcomes of magnetic sphincter augmentation – a community hospital perspective. Am J Surg. 2017;213(6):1019-23. https://doi.org/10.1016/j.amjsurg.2016.09.044
https://doi.org/10.1016/j.amjsurg.2016.0... ,1919 Dominguez-Profeta R, Cheverie JN, Blitzer RR, Lee AM, McClain L, Broderick RC, et al. More beads, more peristaltic reserve, better outcomes: factors predicting postoperative dysphagia after magnetic sphincter augmentation. Surg Endosc. 2021;35(9):5295-302. https://doi.org/10.1007/s00464-020-08013-5
https://doi.org/10.1007/s00464-020-08013... ,2020 Dunn CP, Henning JC, Sterris JA, Won P, Houghton C, Bildzukewicz NA, et al. Regression of Barrett’s esophagus after magnetic sphincter augmentation: intermediate-term results. Surg Endosc. 2021;35(10):5804-9. https://doi.org/10.1007/s00464-020-08074-6
https://doi.org/10.1007/s00464-020-08074... ,2323 Ferrari D, Asti E, Lazzari V, Siboni S, Bernardi D, Bonavina L. Six to 12-year outcomes of magnetic sphincter augmentation for gastroesophageal reflux disease. Sci Rep. 2020;10(1):13753. https://doi.org/10.1038/s41598-020-70742-3
https://doi.org/10.1038/s41598-020-70742... ,2525 Ganz RA, Edmundowicz SA, Taiganides PA, Lipham JC, Smith CD, DeVault KR, et al. Long-term outcomes of patients receiving a magnetic sphincter augmentation device for gastroesophageal reflux. Clin Gastroenterol Hepatol. 2016;14(5):671-7. https://doi.org/10.1016/j.cgh.2015.05.028
https://doi.org/10.1016/j.cgh.2015.05.02... ,2626 Ganz RA, Peters JH, Horgan S. Esophageal sphincter device for gastroesophageal reflux disease. N Engl J Med. 2013;368(21):2039-40. https://doi.org/10.1056/NEJMc1303656
https://doi.org/10.1056/NEJMc1303656... ,2929 Hawasli A, Tarakji M, Tarboush M. Laparoscopic management of severe reflux after sleeve gastrectomy using the LINX® system: technique and one year follow up case report. Int J Surg Case Rep. 2017;30:148-51. https://doi.org/10.1016/j.ijscr.2016.11.050
https://doi.org/10.1016/j.ijscr.2016.11.... ,3232 Lipham JC, DeMeester TR, Ganz RA, Bonavina L, Saino G, Dunn DH, et al. The LINX® reflux management system: confirmed safety and efficacy now at 4 years. Surg Endosc. 2012;26(10):2944-9. https://doi.org/10.1007/s00464-012-2289-1
https://doi.org/10.1007/s00464-012-2289-...

33 Lipham JC, Taiganides PA, Louie BE, Ganz RA, DeMeester TR. Safety analysis of first 1000 patients treated with magnetic sphincter augmentation for gastroesophageal reflux disease. Dis Esophagus. 2015;28(4):305-11. https://doi.org/10.1111/dote.12199
https://doi.org/10.1111/dote.12199... -3434 Louie BE, Smith CD, Smith CC, Bell RCW, Gillian GK, Mandel JS, et al. Objective evidence of reflux control after magnetic sphincter augmentation: one year results from a post approval study. Ann Surg. 2019;270(2):302-8. https://doi.org/10.1097/SLA.0000000000002789
https://doi.org/10.1097/SLA.000000000000... ,4040 Prakash D, Campbell B, Wajed S. Introduction into the NHS of magnetic sphincter augmentation: an innovative surgical therapy for reflux – results and challenges. Ann R Coll Surg Engl. 2018;100(4):251-6. https://doi.org/10.1308/rcsann.2017.0224
https://doi.org/10.1308/rcsann.2017.0224... ,4141 Reynolds JL, Zehetner J, Nieh A, Bildzukewicz N, Sandhu K, Katkhouda N, et al. Charges, outcomes, and complications: a comparison of magnetic sphincter augmentation versus laparoscopic Nissen fundoplication for the treatment of GERD. Surg Endosc. 2016;30(8):3225-30. https://doi.org/10.1007/s00464-015-4635-6
https://doi.org/10.1007/s00464-015-4635-... ,4343 Riva CG, Siboni S, Sozzi M, Lazzari V, Asti E, Bonavina L. High-resolution manometry findings after Linx procedure for gastro-esophageal reflux disease. Neurogastroenterol Motil. 2020;32(3):e13750. https://doi.org/10.1111/nmo.13750
https://doi.org/10.1111/nmo.13750... ,4545 Rona KA, Reynolds J, Schwameis K, Zehetner J, Samakar K, Oh P, et al. Efficacy of magnetic sphincter augmentation in patients with large hiatal hernias. Surg Endosc. 2017;31(5):2096-102. https://doi.org/10.1007/s00464-016-5204-3
https://doi.org/10.1007/s00464-016-5204-... ,4646 Saino G, Bonavina L, Lipham JC, Dunn D, Ganz RA. 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 A. 2015;25(10):787-92. https://doi.org/10.1089/lap.2015.0394
https://doi.org/10.1089/lap.2015.0394... ,4848 Schwameis K, Ayazi S, Zheng P, Grubic AD, Salvitti M, Hoppo T, et al. Efficacy of magnetic sphincter augmentation across the spectrum of gerd disease severity. J Am Coll Surg. 2021;232(3):288-97. https://doi.org/10.1016/j.jamcollsurg.2020.11.012
https://doi.org/10.1016/j.jamcollsurg.20...

49 Sheu EG, Nau P, Nath B, Kuo B, Rattner DW. A comparative trial of laparoscopic magnetic sphincter augmentation and Nissen fundoplication. Surg Endosc. 2015;29(3):505-9. https://doi.org/10.1007/s00464-014-3704-6
https://doi.org/10.1007/s00464-014-3704-... -5050 Tatum JM, Alicuben E, Bildzukewicz N, Samakar K, Houghton CC, Lipham JC. Minimal versus obligatory dissection of the diaphragmatic hiatus during magnetic sphincter augmentation surgery. Surg Endosc. 2019;33(3):782-8. https://doi.org/10.1007/s00464-018-6343-5
https://doi.org/10.1007/s00464-018-6343-... ,5252 Tsai C, Steffen R, Kessler U, Merki H, Lipham J, Zehetner J. Postoperative dysphagia following magnetic sphincter augmentation for gastroesophageal reflux disease. Surg Laparosc Endosc Percutan Tech. 2020;30(4):322-6. https://doi.org/10.1097/SLE.0000000000000785
https://doi.org/10.1097/SLE.000000000000... ,5555 Ward MA, Ebrahim A, Kopita J, Arviso L, Ogola GO, Buckmaster B, et al. Magnetic sphincter augmentation is an effective treatment for atypical symptoms caused by gastroesophageal reflux disease. Surg Endosc. 2020;34(11):4909-15. https://doi.org/10.1007/s00464-019-07278-9
https://doi.org/10.1007/s00464-019-07278... . For instance, a recent study that analyzed the manufacturer’s database reported 29 cases of erosions among 9,453 devices placed (0.3%) over four years of follow-up. Median time to erosion was 26 months, and endoscopic removal of the device was also feasible in the majority of cases11 Alicuben ET, Bell RCW, Jobe BA, Buckley 3rd FP, Daniel Smith C, Graybeal CJ, et al. Worldwide experience with erosion of the magnetic sphincter augmentation device. J Gastrointest Surg. 2018;22(8):1442-7. https://doi.org/10.1007/s11605-018-3775-0
https://doi.org/10.1007/s11605-018-3775-... . The risk of erosion has been linked to the number of beads (smaller devices with small number of beads fit tightly around the esophagus). Bologheanu et al. observed that the presence of fewer than 13 beads was an independent risk factor for developing postoperative dysphagia88 Bologheanu M, Matic A, Feka J, Asari R, Bologheanu R, Riegler FM, et al. Severe dysphagia is rare after magnetic sphincter augmentation. World J Surg. 2022;46(9):2243-50. https://doi.org/10.1007/s00268-022-06573-2
https://doi.org/10.1007/s00268-022-06573... . For that reason, the MSA device with 12 beads was recently removed from the market. Our pooled analysis showed low rates of erosion (1%) and device removal (4%). Nevertheless, we found that the risk of erosion increased significantly for every year of MSA device use (OR 1.40). Therefore, considering the short follow-up of most studies, the risk of esophageal erosion should not be underestimated yet.

The Nissen fundoplication is still the mainstay of surgical treatment for GERD. Interestingly, a recent meta-analysis comparing MSA with fundoplication concluded that there were no significant differences between the procedures in terms of PPIs usage, GERD-HRQL score, dysphagia, and reoperation rates2828 Guidozzi N, Wiggins T, Ahmed AR, Hanna GB, Markar SR. Laparoscopic magnetic sphincter augmentation versus fundoplication for gastroesophageal reflux disease: systematic review and pooled analysis. Dis Esophagus. 2019;32(9):doz031. https://doi.org/10.1093/dote/doz031
https://doi.org/10.1093/dote/doz031... . Another matched pair analysis showed that patients undergoing MSA procedure achieved similar symptom control with less gas-related symptoms, and greater ability to belch4242 Reynolds JL, Zehetner J, Wu P, Shah S, Bildzukewicz N, Lipham JC. Laparoscopic magnetic sphincter augmentation vs laparoscopic nissen fundoplication: a matched-pair analysis of 100 patients. J Am Coll Surg. 2015;221(1):123-8. https://doi.org/10.1016/j.jamcollsurg.2015.02.025
https://doi.org/10.1016/j.jamcollsurg.20... . Other potential advantages of laparoscopic placement of MSA device include that it is less technically demanding, requires minimal dissection of the gastric fundus, and has no permanent anatomical alterations3131 Kuckelman JP, Barron MR, Martin MJ. "The missing LINX" for gastroesophageal reflux disease: Operative techniques video for the Linx magnetic sphincter augmentation procedure. Am J Surg. 2017;213(5):984-7. https://doi.org/10.1016/j.amjsurg.2017.03.018
https://doi.org/10.1016/j.amjsurg.2017.0... . On the other hand, opposite to MSA procedure, the fundoplication has been used for more than 65 years and has already proven excellent long-term effectiveness1717 Dallemagne B, Weerts J, Markiewicz S, Dewandre JM, Wahlen C, Monami B, et al. Clinical results of laparoscopic fundoplication at ten years after surgery. Surg Endosc. 2006;20(1):159-65. https://doi.org/10.1007/s00464-005-0174-x
https://doi.org/10.1007/s00464-005-0174-... ,3838 Morgenthal CB, Shane MD, Stival A, Gletsu N, Milam G, Swafford V, et al. The durability of laparoscopic Nissen fundoplication: 11-year outcomes. J Gastrointest Surg. 2007;11(6):693-700. https://doi.org/10.1007/s11605-007-0161-8
https://doi.org/10.1007/s11605-007-0161-... ,4444 Robinson B, Dunst CM, Cassera MA, Reavis KM, Sharata A, Swanstrom LL. 20 years later: laparoscopic fundoplication durability. Surg Endosc. 2015;29(9):2520-4. https://doi.org/10.1007/s00464-014-4012-x
https://doi.org/10.1007/s00464-014-4012-... . High expenses and lack of coverage by many insurance companies are also drawbacks of the MSA device that should be considered.

This study has several limitations. First, several methodological design discrepancies were noted among the analyzed studies. Second, most studies included in the analysis had a short follow-up. Third, statistical heterogeneity was relevant in many of the assessed outcomes. Finally, few studies evaluated patients with postoperative pH monitoring. Future studies should include standardized diagnostic methods to allow objective and comparable assessment of outcomes.

CONCLUSIONS

The MSA device is an effective treatment modality for GERD. Most patients undergoing MSA placement achieve symptom relief and improvement in quality of life. Postoperative dysphagia is common after the procedure. Although esophageal erosion is rare, its risk increases significantly over time. Further studies with objective assessment of results and longer follow-up are still needed.

  • Financial source: None
  • Editorial Support: National Council for Scientific and Technological Development (CNPq).
  • Central Message
    Gastroesophageal reflux disease (GERD) significantly impairs quality of life and work productivity. It also represents a substantial financial burden to the health-care system. Dietary and lifestyle modifications along with antireflux medication are recommended for the treatment for GERD. The laparoscopic fundoplication has been the most common surgical procedure to treat GERD in the last decades; however, in 2008, a novel laparoscopically implantable magnetic sphincter augmentation (MSA) device was described, which was designed to restore the lower esophageal sphincter barrier function.
  • Perspectives
    The magnetic sphincter augmentation device is an effective treatment modality for GERD. Most patients undergoing MSA placement achieve symptom relief and improvement in quality of life. Postoperative dysphagia is common after the procedure. Although esophageal erosion is rare, its risk increases significantly over time. Further studies with objective assessment of results and longer follow-up are still needed.

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Publication Dates

  • Publication in this collection
    04 Mar 2024
  • Date of issue
    2023

History

  • Received
    28 Nov 2022
  • Accepted
    10 Sept 2023
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