Skip to main content
Top
Published in: Obesity Surgery 1/2023

Open Access 06-12-2022 | Sleeve Gastrectomy | New Concept

Feasibility and Efficacy of Magnetic Sphincter Augmentation for the Management of Gastroesophageal Reflux Disease Post-Sleeve Gastrectomy for Obesity

Authors: Leena Khaitan, Michael Hill, Michael Michel, Patrick Chiasson, Philip Woodworth, Reginald Bell, Ragui Sadek, Aaron Hoffman, Kari Loing, Paula Veldhuis, William Petraiuolo, Carlos Anciano

Published in: Obesity Surgery | Issue 1/2023

Login to get access

Abstract

Background

Patients with medically intractable GERD after laparoscopic sleeve gastrectomy (LSG) have limited surgical options. Fundoplication is difficult post-LSG. Roux-en-Y gastric bypass may be used as a conversion procedure but is more invasive with potential for serious complications. Magnetic sphincter augmentation (MSA) is a less invasive GERD treatment alternative. The objective of this study was to assess safety and efficacy outcomes of MSA after LSG.

Methods

The primary outcome of this observational, multicenter, single-arm prospective study was the rate of serious device and/or procedure-related adverse events (AEs). The efficacy of the LINX device was measured comparing baseline to 12-month post-implant reductions in distal acid exposure, GERD-HRQL score, and average daily PPI usage.

Results

Thirty subjects who underwent MSA implantation were followed 12 months post-implant. No unanticipated adverse device effects were observed. There were two adverse events deemed serious (dysphagia, pain, 6.7%) which resolved without sequelae. GERD-HRQL scores showed significant improvement (80.8%, P < 0.001), and reduction in daily PPI usage was seen (95.8%, P < 0.001). Forty-four percent of subjects demonstrated normalization or >  = 50% reduction of total distal acid exposure time (baseline 16.2%, 12 months 11%; P = 0.038).

Conclusions

Post-LSG, MSA showed an overall improvement of GERD symptoms, and reduction in PPI use with explants within anticipated range along with improvement in distal esophageal acid exposure time.

Graphical Abstract

Literature
1.
go back to reference Welbourn R, et al. Bariatric surgery worldwide: baseline demographic description and one-year outcomes from the second IFSO global registry report 2013–2015. Obes Surg. 2018;28(2):313–22.CrossRef Welbourn R, et al. Bariatric surgery worldwide: baseline demographic description and one-year outcomes from the second IFSO global registry report 2013–2015. Obes Surg. 2018;28(2):313–22.CrossRef
2.
go back to reference Vidal P, et al. Laparoscopic gastric bypass versus laparoscopic sleeve gastrectomy as a definitive surgical procedure for morbid obesity. Mid-Term Results Obesity Surgery. 2013;23(3):292–9.CrossRef Vidal P, et al. Laparoscopic gastric bypass versus laparoscopic sleeve gastrectomy as a definitive surgical procedure for morbid obesity. Mid-Term Results Obesity Surgery. 2013;23(3):292–9.CrossRef
3.
go back to reference Angrisani L, et al. Bariatric surgery worldwide 2013. Obes Surg. 2015;25(10):1822–32.CrossRef Angrisani L, et al. Bariatric surgery worldwide 2013. Obes Surg. 2015;25(10):1822–32.CrossRef
4.
go back to reference DuPree CE, et al. Laparoscopic sleeve gastrectomy in patients with preexisting gastroesophageal reflux disease : a national analysis. JAMA Surg. 2014;149(4):328–34.CrossRef DuPree CE, et al. Laparoscopic sleeve gastrectomy in patients with preexisting gastroesophageal reflux disease : a national analysis. JAMA Surg. 2014;149(4):328–34.CrossRef
5.
go back to reference Boza C, et al. Long-term outcomes of laparoscopic sleeve gastrectomy as a primary bariatric procedure. Surg Obes Relat Dis. 2014;10(6):1129–33.CrossRef Boza C, et al. Long-term outcomes of laparoscopic sleeve gastrectomy as a primary bariatric procedure. Surg Obes Relat Dis. 2014;10(6):1129–33.CrossRef
6.
go back to reference Parmar CD, et al. Conversion of sleeve gastrectomy to Roux-en-Y gastric bypass is effective for gastro-oesophageal reflux disease but not for further weight loss. Obes Surg. 2017;27(7):1651–8.CrossRef Parmar CD, et al. Conversion of sleeve gastrectomy to Roux-en-Y gastric bypass is effective for gastro-oesophageal reflux disease but not for further weight loss. Obes Surg. 2017;27(7):1651–8.CrossRef
7.
go back to reference Desart K, et al. Gastroesophageal reflux management with the LINX® system for gastroesophageal reflux disease following laparoscopic sleeve gastrectomy. J Gastrointest Surg. 2015;19(10):1782–6.CrossRef Desart K, et al. Gastroesophageal reflux management with the LINX® system for gastroesophageal reflux disease following laparoscopic sleeve gastrectomy. J Gastrointest Surg. 2015;19(10):1782–6.CrossRef
8.
go back to reference Riva CG, et al. Magnetic sphincter augmentation after gastric surgery. JSLS : J Soc Laparoendosc Surg. 2019;23(4): p. e2019.00035. Riva CG, et al. Magnetic sphincter augmentation after gastric surgery. JSLS : J Soc Laparoendosc Surg. 2019;23(4): p. e2019.00035.
9.
go back to reference Broderick RC, et al. Magnetic sphincter augmentation: a viable rescue therapy for symptomatic reflux following bariatric surgery. Surg Endosc. 2020;34(7):3211–5.CrossRef Broderick RC, et al. Magnetic sphincter augmentation: a viable rescue therapy for symptomatic reflux following bariatric surgery. Surg Endosc. 2020;34(7):3211–5.CrossRef
10.
go back to reference Kuckelman JP, et al. Esophageal magnetic sphincter augmentation as a novel approach to post-bariatric surgery gastroesophageal reflux disease. Obes Surg. 2018;28(10):3080–6.CrossRef Kuckelman JP, et al. Esophageal magnetic sphincter augmentation as a novel approach to post-bariatric surgery gastroesophageal reflux disease. Obes Surg. 2018;28(10):3080–6.CrossRef
11.
go back to reference Bonavina L, et al. LINX® Reflux Management System in chronic gastroesophageal reflux: a novel effective technology for restoring the natural barrier to reflux. Ther Adv Gastroenterol. 2013;6(4):261–8.CrossRef Bonavina L, et al. LINX® Reflux Management System in chronic gastroesophageal reflux: a novel effective technology for restoring the natural barrier to reflux. Ther Adv Gastroenterol. 2013;6(4):261–8.CrossRef
12.
go back to reference Louie BE, et al. Objective evidence of reflux control after magnetic sphincter augmentation: one year results from a post approval study. Ann Surg. 2019;270(2). Louie BE, et al. Objective evidence of reflux control after magnetic sphincter augmentation: one year results from a post approval study. Ann Surg. 2019;270(2).
13.
go back to reference Lipham JC, et al. The LINX® reflux management system: confirmed safety and efficacy now at 4 years. Surg Endosc. 2012;26(10):2944–9.CrossRef Lipham JC, et al. The LINX® reflux management system: confirmed safety and efficacy now at 4 years. Surg Endosc. 2012;26(10):2944–9.CrossRef
14.
go back to reference Katz P, et al. Improvement in symptoms and QOL is sustained with minimal side effects 4 years after magnetic sphincter augmentation (LINX) for GERD: 100. Off J Am Coll Gastroenterol | ACG, 2014;109. Katz P, et al. Improvement in symptoms and QOL is sustained with minimal side effects 4 years after magnetic sphincter augmentation (LINX) for GERD: 100. Off J Am Coll Gastroenterol | ACG, 2014;109.
15.
go back to reference Ganz RA, et al. Esophageal sphincter device for gastroesophageal reflux disease. N Engl J Med. 2013;368(8):719–27.CrossRef Ganz RA, et al. Esophageal sphincter device for gastroesophageal reflux disease. N Engl J Med. 2013;368(8):719–27.CrossRef
16.
go back to reference Velanovich V. The development of the GERD-HRQL symptom severity instrument. Dis Esophagus. 2007;20(2):130–4.CrossRef Velanovich V. The development of the GERD-HRQL symptom severity instrument. Dis Esophagus. 2007;20(2):130–4.CrossRef
17.
go back to reference Felinska E, et al. Do we understand the pathophysiology of GERD after sleeve gastrectomy? Ann N Y Acad Sci. 2020;1482(1):26–35.CrossRef Felinska E, et al. Do we understand the pathophysiology of GERD after sleeve gastrectomy? Ann N Y Acad Sci. 2020;1482(1):26–35.CrossRef
18.
go back to reference Katz PO, Gerson LB and Vela MF. Guidelines for the diagnosis and management of gastroesophageal reflux disease. Am J Gastroenterol. 2013;108(3):p. 308–28; quiz 329. Katz PO, Gerson LB and Vela MF. Guidelines for the diagnosis and management of gastroesophageal reflux disease. Am J Gastroenterol. 2013;108(3):p. 308–28; quiz 329.
19.
go back to reference Vela MF. Medical treatments of GERD: the old and new. Gastroenterol Clin North Am. 2014;43(1):121–33.CrossRef Vela MF. Medical treatments of GERD: the old and new. Gastroenterol Clin North Am. 2014;43(1):121–33.CrossRef
20.
go back to reference Savarino E, et al. A review of pharmacotherapy for treating gastroesophageal reflux disease (GERD). Expert Opin Pharmacother. 2017;18(13):1333–43.CrossRef Savarino E, et al. A review of pharmacotherapy for treating gastroesophageal reflux disease (GERD). Expert Opin Pharmacother. 2017;18(13):1333–43.CrossRef
21.
go back to reference Jaruvongvanich V, et al. Esophageal pathophysiologic changes and adenocarcinoma after bariatric surgery: a systematic review and meta-analysis. Clin Transl Gastroenterol. 2020;11(8):e00225.CrossRef Jaruvongvanich V, et al. Esophageal pathophysiologic changes and adenocarcinoma after bariatric surgery: a systematic review and meta-analysis. Clin Transl Gastroenterol. 2020;11(8):e00225.CrossRef
22.
go back to reference Balla A, et al. Manometric and pH-monitoring changes after laparoscopic sleeve gastrectomy: a systematic review. Langenbecks Arch Surg. 2021;406(8):2591–609.CrossRef Balla A, et al. Manometric and pH-monitoring changes after laparoscopic sleeve gastrectomy: a systematic review. Langenbecks Arch Surg. 2021;406(8):2591–609.CrossRef
23.
go back to reference Alhaj Saleh A, et al. Does sleeve shape make a difference in outcomes? Obes Surg. 2018;28(6):1731–7.CrossRef Alhaj Saleh A, et al. Does sleeve shape make a difference in outcomes? Obes Surg. 2018;28(6):1731–7.CrossRef
24.
go back to reference Altieri MS, Pryor AD. Gastroesophageal reflux disease after bariatric procedures. The Surgical clinics of North America. 2015;95(3):579–91.CrossRef Altieri MS, Pryor AD. Gastroesophageal reflux disease after bariatric procedures. The Surgical clinics of North America. 2015;95(3):579–91.CrossRef
26.
go back to reference Schwameis K, et al. Efficacy of magnetic sphincter augmentation across the spectrum of GERD disease severity. J Am Coll Surg. 2021;232(3):288–97.CrossRef Schwameis K, et al. Efficacy of magnetic sphincter augmentation across the spectrum of GERD disease severity. J Am Coll Surg. 2021;232(3):288–97.CrossRef
27.
go back to reference Yadlapati R, et al. Management options for patients with GERD and persistent symptoms on proton pump inhibitors: recommendations from an expert panel. Am J Gastroenterol. 2018;113(7):980–6.CrossRef Yadlapati R, et al. Management options for patients with GERD and persistent symptoms on proton pump inhibitors: recommendations from an expert panel. Am J Gastroenterol. 2018;113(7):980–6.CrossRef
28.
go back to reference Asti E, et al. Magnetic sphincter augmentation for gastroesophageal reflux disease: review of clinical studies. Updat Surg. 2018;70(3):323–30.CrossRef Asti E, et al. Magnetic sphincter augmentation for gastroesophageal reflux disease: review of clinical studies. Updat Surg. 2018;70(3):323–30.CrossRef
29.
go back to reference DeMarchi J, et al. Evolution of a novel technology for gastroesophageal reflux disease: a safety perspective of magnetic sphincter augmentation. Dis Esophagus. 2021;34(11):p. doab036. DeMarchi J, et al. Evolution of a novel technology for gastroesophageal reflux disease: a safety perspective of magnetic sphincter augmentation. Dis Esophagus. 2021;34(11):p. doab036.
30.
go back to reference Johnson LF, DeMeester TR. Development of the 24-hour intraesophageal pH monitoring composite scoring system. J Clin Gastroenterol. 1986;8(Suppl 1):52–8.CrossRef Johnson LF, DeMeester TR. Development of the 24-hour intraesophageal pH monitoring composite scoring system. J Clin Gastroenterol. 1986;8(Suppl 1):52–8.CrossRef
31.
go back to reference Alicuben ET, et al. Worldwide experience with erosion of the magnetic sphincter augmentation device. J Gastrointest Surg. 2018;22(8):1442–7.CrossRef Alicuben ET, et al. Worldwide experience with erosion of the magnetic sphincter augmentation device. J Gastrointest Surg. 2018;22(8):1442–7.CrossRef
32.
go back to reference Asti E, et al. Removal of the magnetic sphincter augmentation device: surgical technique and results of a single-center cohort study. Ann Surg. 2017;265(5):941–5.CrossRef Asti E, et al. Removal of the magnetic sphincter augmentation device: surgical technique and results of a single-center cohort study. Ann Surg. 2017;265(5):941–5.CrossRef
Metadata
Title
Feasibility and Efficacy of Magnetic Sphincter Augmentation for the Management of Gastroesophageal Reflux Disease Post-Sleeve Gastrectomy for Obesity
Authors
Leena Khaitan
Michael Hill
Michael Michel
Patrick Chiasson
Philip Woodworth
Reginald Bell
Ragui Sadek
Aaron Hoffman
Kari Loing
Paula Veldhuis
William Petraiuolo
Carlos Anciano
Publication date
06-12-2022
Publisher
Springer US
Published in
Obesity Surgery / Issue 1/2023
Print ISSN: 0960-8923
Electronic ISSN: 1708-0428
DOI
https://doi.org/10.1007/s11695-022-06381-6

Other articles of this Issue 1/2023

Obesity Surgery 1/2023 Go to the issue