ABSTRACT
Introduction
Magnetic Sphincter Augmentation (MSA) has emerged as a possible surgical option in patients with gastroesophageal reflux following sleeve gastrectomy (SG). The published literature primarily originates from Western populations, with no reported cases outside the U.S. The purpose of this study was to review the current literature on the use of MSA for treating gastroesophageal reflux after SG and analyze our institution's experience.
Methods
A literature search of PubMed, EMBASE, Cochrane, and Scopus was conducted from inception to 3 May 2025 to identify studies describing the use of MSA for gastroesophageal reflux following SG. Additionally, all consecutive patients who underwent MSA implantation for gastroesophageal reflux following SG between June 2019 and December 2023 were identified from our institution's database.
Results
The scoping review identified eight studies from the U.S., reporting on 108 patients. More than half of these patients no longer required daily PPI use after MSA implantation. Compared to pre‐MSA GERD‐HRQL scores, which ranged from 17.1 to 46.0, post‐MSA scores were lower, ranging from 4.1 to 19.0. This first Asian case series included seven patients and found that, following MSA implantation, six out of seven continued to report daily proton pump inhibitor (PPI) use. The mean pre‐MSA Gastroesophageal Reflux Disease–Health‐Related Quality of Life (GERD‐HRQL) score was 44.4, and the mean modified DeMeester symptom score was 4.1. These improved to 31.4 (p = 0.06) and 3.0 (p = 0.27), respectively, post‐MSA. No MSA‐related adverse events were recorded.
Conclusion
While the scoping review suggested that MSA may lead to symptomatic improvement in selected patients with gastroesophageal reflux following SG, this is based on low‐level evidence. Our case series showed that only modest symptom improvements were observed following MSA for the treatment of reflux after SG in the Asian population.
Keywords: gastroesophageal reflux, magnetic sphincter augmentation, patient reported outcome, quality of life, sleeve gastrectomy
1. Introduction
Bariatric surgery remains the most sustainable treatment for achieving long‐term weight loss and managing obesity‐related comorbidities. Among these procedures, sleeve gastrectomy (SG) is the most commonly performed bariatric surgery worldwide [1]. However, gastroesophageal reflux remains a significant concern following SG. A meta‐analysis reported that the incidence of de novo reflux, esophagitis and Barrett's esophagitis after SG was 23%, 28%, and 8% respectively [2]. Gastroesophageal reflux after SG is initially managed with medications such as proton pump inhibitors. In cases where reflux is refractory to medical therapy, conversion to Roux‐en‐Y gastric bypass (RYGB) is recommended by most international expert panel [3, 4]. However, RYGB may not be an ideal surgical option for patients with contraindications to RYGB in the first place or those who have achieved adequate weight loss after the initial SG [5]. Additionally, RYGB is associated with a change in anatomical configuration, a risk of internal hernia, and other surgical and metabolic complications.
Magnetic Sphincter Augmentation (MSA) has emerged as a possible surgical option in patients with gastroesophageal reflux following sleeve gastrectomy (SG). It utilizes the LINX Reflux Management System (Ethicon, Johnson & Johnson), which is placed around the lower esophageal sphincter to augment a physiologic anti‐reflux valve. Approved by the U.7. Food and Drug Administration in 2012 for the treatment of primary GERD, it has since been used beyond its initial indications to include patients with gastroesophageal reflux after SG [6]. However, to date, published literature on the use of MSA for treating reflux after SG originates from Western populations, with no reported cases outside the U.S. [7]. The purpose of this study was to analyze and report outcomes after MSA implantation in Asian patients with gastroesophageal reflux following SG, and to review the current literature on the use of MSA for this indication.
2. Material and Methods
2.1. Scoping Review
The scoping review was conducted in accordance with the Preferred Reporting Items for Systematic Reviews and Meta‐Analyses (PRISMA) Guidelines.
2.2. Search Strategy
An electrotonic literature search was conducted on major databases including PubMed, Embase, Cochrane and Scopus from inception to 3rd May 2025. A combination of Medical Subject Headings (MeSH) terms and non‐MeSH terms using Boolean operators was used in PubMed: ((“Gastroesophageal Reflux”[Mesh]) OR (reflux[Title/Abstract])) AND ((“Gastrectomy”[Mesh]) OR (sleeve gastrectom[Title/Abstract]) OR (bariatric[Title/Abstract])) AND ((Magnetic Sphincter Augmentation* [Title/Abstract]) OR (LINX[Title/Abstract])). The full electronic search strategy can be found in Data S3.
2.3. Eligibility Criteria
All studies describing the use of MSA for gastroesophageal reflux following SG were included. SG procedures using any surgical approach (laparoscopic and robotic) were eligible, as the approach was not expected to influence the study question. Studies were excluded if most patients had undergone bariatric procedures other than SG prior to MSA implantation and individual patient data for SG patients were not reported. Additional exclusion criteria included studies that did not report post‐MSA GERD‐HRQL scores, review articles, unpublished studies, conference abstracts, and non‐human studies. No restrictions were placed on language or date of publication.
2.4. Study Selection
All studies were imported into EndNote X9 and duplicate studies were removed electronically then manually searched. Two reviewers independently (M.Y., D.C.) screened and assessed the studies for potential inclusion by their titles and abstracts. Disagreements were resolved by consensus, or by appeal to a senior author (A.S.).
2.5. Data Extraction and Outcomes of Interest
Two reviewers (M.Y., D.C.) independently extracted the demographic data of the study population (first author, year of publication, number of patients, age, sex, pre‐MSA BMI, pre‐MSA daily PPI use, pre‐MSA GERD‐HRQL score, time from SG to MSA, and follow‐up period) and outcomes of interest (post‐MSA PPI use and post‐MSA GERD‐HRQL score). Any disagreements were resolved by consensus or by appeal to a senior author (A.S.).
2.6. Case Series
This study was exempted from our institutional review board as only anonymized data was utilized (NHG DSRB Ref: 2024/00245).
2.7. Study Design and Population
All consecutive patients who underwent MSA implantation for gastroesophageal reflux following SG between June 2019 and December 2023 were identified from our institution's prospectively maintained electronic clinical database. All prior SG procedures were performed laparoscopically.
2.8. Data Collection
Demographic and clinical data were collected, including age, sex, ethnicity, pre‐MSA BMI, pre‐MSA daily proton pump inhibitor (PPI) use, pre‐MSA Gastroesophageal Reflux Disease–Health‐Related Quality of Life (GERD‐HRQL) score, pre‐MSA modified DeMeester symptom scoring system, presence of hiatal hernia on endoscopy according to Hill's classification [8], presence of esophagitis on endoscopy according to the Los Angeles (LA) classification [9], pre‐MSA high resolution manometry (HRM) findings, pre‐MSA Acid Exposure Time (AET) on the pH‐impedance monitoring, time from SG to MSA, and follow up period were collected. The GERD‐HRQL questionnaire and modified DeMeester symptom scoring system are provided in Data S1 and S2, respectively. AET was defined as the percentage of time the esophageal pH was < 4 over a 24‐h period. An AET > 6% on pH‐impedance monitoring was considered diagnostic of gastroesophageal reflux disease [10]. Outcomes of interest included length of hospital stay, post‐MSA daily PPI use, post‐MSA GERD‐HRQL score, post‐MSA modified DeMeester symptom scoring system, and MSA‐related adverse events. Length of hospital stay was calculated from the date of MSA implantation to the date of discharge. The post‐MSA GERD‐HRQL score and modified DeMeester symptom scoring system were collected one year after MSA implantation.
2.9. Operative Technique
The steps of laparoscopic SG were previously described [11]. All patients underwent laparoscopic magnetic sphincter augmentation (MSA) using the LINX Reflux Management System (Ethicon, Johnson & Johnson). The procedure began with lysis of adhesions as needed, followed by crural dissection and division of the phrenoesophageal ligament to expose the bilateral diaphragmatic crura. Circumferential mobilization of the mediastinal esophagus was performed to achieve an adequate intra‐abdominal esophageal length of 3–4 cm. Posterior crural repair was performed using interrupted 2/0 braided, non‐absorbable multifilament sutures, closely approximating the esophagus. The posterior vagus nerve was carefully identified and preserved. A window was created between the posterior vagus nerve and the esophagus at the level of the lower esophageal sphincter to accommodate the LINX device. A dedicated sizing tool was used intraoperatively to determine the appropriate device size, and the LINX Reflux Management System was then implanted accordingly [12].
2.10. Post‐Operative Management and Follow‐Up
Postoperatively, patients were observed in the general ward and discharged once they tolerated a soft diet. The first follow‐up was scheduled 2 weeks after discharge. Subsequent follow‐ups were conducted at 1, 3, 6, 12, and 18 months, and at 2 years post‐discharge, followed by annual reviews. Additional follow‐up visits were arranged as needed.
2.11. Statistical Analysis
Missing data were imputed by methods previously described in the Cochrane Handbook, by Hozo et al. [13]. Summary statistical analyses were performed using STATA version 14 (StataCorp, College Station, TX, USA). Pre‐ and post‐MSA GERD‐HRQL and modified DeMeester symptom scores were compared using the paired t‐test.
3. Results
3.1. Scoping Review
A total of 164 records were identified through database searching. After removing duplicates, 103 records were screened. Following the exclusion of 88 articles, 15 full‐text articles were retrieved and assessed for eligibility. Five studies were excluded due to the absence of post‐MSA GERD‐HRQL scores [14, 15, 16, 17, 18], one study was excluded due to overlap in the patient cohort [19], and another was excluded because it primarily included patients who had not undergone sleeve gastrectomy [6]. Ultimately, eight studies reporting 108 patients were included in the analysis (Figure 1) [20, 21, 22, 23, 24, 25, 26, 27]. All the studies came from the United States, with the majority of the studies being case series. The results of all studies are summarized in Table 1. The mean age of patients ranged from 37 to 55.6 years old, with the majority of patients being female. The mean BMI ranged from 28.0 to 35.4 kg/m2. Almost all patients were on daily PPI use pre‐MSA. The mean time from SG to MSA implantation ranged from 12.0 to 43.6 months. The mean follow‐up period ranged from 0.5 to 63 months. More than half of the patients reported that daily PPI use was no longer required post‐MSA. Compared to the mean pre‐MSA GERD‐HRQL score, which ranged from 17.1 to 46.0, there was a reduction of the mean GERD‐HRQL score post‐MSA, which ranged from 4.1 to 19.0.
FIGURE 1.
PRISMA flowchart.
TABLE 1.
Studies reporting on Magnetic Sphincter Augmentation following Sleeve Gastrectomy.
| First author, year | Study design | Number of patients | Age, years, mean ± SD | Sex (Male: Female) | BMI, kg/m2, mean ± SD | Pre‐MSA daily PPI use | Pre‐MSA GERD‐HRQL score, mean ± SD | Time from SG to MSA, months, mean ± SD | Post‐MSA daily PPI use | Post‐MSA GERD‐HRQL score, mean ± SD | Follow up period, months, mean ± SD |
|---|---|---|---|---|---|---|---|---|---|---|---|
| Jefferies 2024 | Retrospective cohort | 18 | 55.1 ± 9.7 | 3:15 | 29.4 ± 3.9 | NR | 31.6 ± 9.4 | NR | 7/11 | 8.5 ± 1.7 | 12 |
| Peine 2024 | Retrospective case series | 5 | 55.6 ± 7.7 | 1:4 | 31.0 ± 3.5 | 5/5 | 30.2 ± 9.7 | 36.5 ± 9.2 | 2/5 | 9.6 ± 15.1 | 18.8 ± 15.3 |
| Khaitan 2023 | Prospective case series | 30 | 47.1 ± 12.1 | 3:27 | 29.9 ± 3.2 | 30/30 | 35.6 ± 9.7 | 38.4 | 4/26 | 8.1 ± 11.3 | 12 |
| Hawasli 2023 | Retrospective case series | 17 | 54 ± 12 | 3:14 | 31.0 ± 6.0 | NR | 46 ± 19 | 41.0 ± 19.0 | 13/16 | 19 ± 14 | 63 ± 31 |
| Patel 2022 | Retrospective case series | 22 | 46 ± 10.9 | 2:20 | 32.9 ± 6.7 | 21/22 | 43.8 ± 11.3 | 43.6 ± 30.1 | 17/22 | 16.7 ± 12.8 | 9 ± 5.6 |
| Broderick 2020 | Retrospective case series | 8 | 43.1 ± 8.9 | 1:7 | 28.0 ± 4.0 | 7/8 | 25 | NR | 1/8 | 8 | 20.8 |
| Ndubizu 2020 | Retrospective case report | 1 | 37 | 0:1 | 30.6 | 1/1 | 45 | 12 | 0/1 | 14 | 12 |
| Desart 2015 | Retrospective case series | 7 | 50.4 ± 7.0 | 5:2 | 35.4 ± 7.2 | 7/7 | 17.1 ± 0.4 | 18.1 ± 10.9 | NR | 4.1 ± 0.4 | 0.5–1 |
| Current study | Retrospective case series | 7 | 44.1 ± 11.4 | 4:3 | 28.5 ± 3.6 | 7/7 | 44.4 ± 16.3 | 69.1 ± 26.8 | 6/7 | 31.4 ± 27.2 | 39.1 ± 25.4 |
Abbreviations: BMI, body mass index; GERD‐HRQL, gastroesophageal reflux disease‐health‐related quality of life; MSA, magnetic sphincter augmentation; NR, not reported; PPI, Proton pump inhibitor; SD, standard deviation; SG, sleeve gastrectomy.
3.2. Case Series
A total of seven patients were initially identified from our institution's prospectively maintained electronic clinical database. Four were male and three were female. The mean age was 44.1 years, and the mean pre‐MSA BMI was 28.5 kg/m2. Individual patient demographic data are presented in Table 2. All patients reported daily PPI use prior to MSA. Most patients had some degree of hiatal hernia, and all had evidence of esophagitis on endoscopy. Only one patient demonstrated ineffective esophageal motility, while the remaining HRM results were normal. All patients who underwent pre‐MSA pH‐impedance monitoring were diagnosed with GERD, with AET values ranging from 11.9% to 75.4%. The mean time from SG to MSA was 69.1 months. The mean length of hospital stay was 2.9 days. Following MSA implantation, six out of seven patients continued to report daily PPI use. The mean pre‐MSA GERD‐HRQL score was 44.4, and the mean pre‐MSA modified DeMeester symptom score was 4.1, which improved to 31.4 (p = 0.06) and 3.0 (p = 0.27), respectively, post‐MSA. No MSA‐related adverse events were recorded. Postoperative outcomes for individual patients are shown in Table 3. The mean follow‐up period was 43.4 months.
TABLE 2.
Demographics.
| Patient | Age, years | Sex | Ethnicity | Pre‐MSA BMI, kg/m2 | Pre‐MSA daily PPI use | Pre‐MSA GERD‐HRQL score | Pre‐MSA modified DeMeester symptom scoring system | Hiatal hernia on endoscopy, hills classification | Presence of esophagitis on endoscopy, Los Angeles classification | Pre‐MSA high resolution manometry | Pre‐MSA pH‐impedance monitoring | Time from SG to MSA, months |
|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 1 | 34 | Male | Chinese | 25.4 | Yes | 28 | 4 | 3 | C | Normal | GERD | 76.5 |
| 2 | 37 | Male | Others | 27.7 | Yes | 30 | 5 | 3 | B | Normal | GERD | 52.3 |
| 3 | 49 | Male | Indian | 33.8 | Yes | 45 | 5 | 1 | D | Normal | GERD | 97.0 |
| 4 | 52 | Female | Others | 33.4 | Yes | 73 | 4 | 4 | C | Ineffective esophageal motility | GERD | 45.0 |
| 5 | 64 | Female | Malay | 25.5 | Yes | 32 | 2 | 3 | B | NA | NA | 30.8 |
| 6 | 33 | Female | Indian | 26.0 | Yes | 47 | 4 | 1 | C | Normal | GERD | 81.2 |
| 7 | 40 | Male | Caucasian | 27.8 | Yes | 56 | 5 | 3 | C | Normal | NA | 100.6 |
Abbreviations: BMI, body mass index; GERD, gastro‐esophageal reflux disease; GERD‐HRQL, gastroesophageal reflux disease‐health‐related quality of life; MSA, magnetic sphincter augmentation; NA, not available; PPI, Proton pump inhibitor; SG, sleeve gastrectomy.
TABLE 3.
Post‐operative outcomes.
| Patient | Length of hospital stay, days | Post‐MSA daily PPI use | Post‐MSA GERD‐HRQL score | Post‐MSA modified DeMeester symptom scoring system | MSA related adverse events | Follow up period, months |
|---|---|---|---|---|---|---|
| 1 | 4 | Yes | 17 | 2 | None | 60.5 |
| 2 | 1 | Yes | 18 | 1 | None | 33.3 |
| 3 | 5 | Yes | 10 | 1 | None | 25.9 |
| 4 | 4 | Yes | 75 | 6 | None | 67.1 |
| 5 | 2 | No | 0 | 0 | None | 50.0 |
| 6 | 3 | Yes | 50 | 5 | None | 51.9 |
| 7 | 1 | Yes | 50 | 6 | None | 15.4 |
Abbreviations: GERD‐HRQL, gastroesophageal reflux disease‐health‐related quality of life; MSA, magnetic sphincter augmentation; PPI, Proton pump inhibitor.
4. Discussion
Gastroesophageal reflux following sleeve gastrectomy (SG) is a challenging clinical problem. Magnetic Sphincter Augmentation (MSA) has shown promise, but all the data originates from Western populations. Based on our institution's experience—the first reported data from an Asian population—only modest improvements were observed in symptoms following MSA for the treatment of reflux after SG, as measured by the GERD‐HRQL score, modified DeMeester symptom score, and daily PPI use. In contrast, studies from the U.S. have reported greater symptom improvement and more substantial reductions in daily PPI use after MSA implantation. However, a statistically significant change in the HRQL instrument scores does not necessarily imply clinical significance [28]. This underscores the importance of defining the minimal change in HRQL scores that is considered meaningful to patients, known as the Minimal Clinically Important Difference (MCID). MCID has been defined as the smallest change in score within any domain that patients perceive as beneficial [29]. MCID values are therefore essential for interpreting the clinical relevance of observed changes, as treatment success would then be assessed by the proportion of patients who reach the MCID threshold, rather than by the average change across a group. The MCID for the GERD‐HRQL score in patients undergoing MSA for the treatment of gastroesophageal reflux following SG was not reported in any of the studies. To the best of our knowledge, no MCID for the GERD‐HRQL has been reported in the existing literature. This remains an important area for future research.
MSA was initially developed for the treatment of primary GERD refractory to medical therapy. The manufacturer provided strict patient selection criteria, including: no hiatal hernia > 3 cm or paraesophageal hernia, no esophagitis worse than LA class A or B, adequate esophageal motility with > 70% effective swallows and a distal wave amplitude > 35 mmHg, a body mass index (BMI) < 35 kg/m2, no Barrett's esophagus, and no prior esophageal or gastric surgery. In patients with primary GERD, those with LA class C or D esophagitis have been reported to experience less improvement in GERD‐HRQL scores compared to those with LA class A or B esophagitis [30]. This may explain the modest symptom improvement observed in our case series, as the majority of patients had LA class C or D esophagitis. The use of MSA beyond the initially recommended criteria remains experimental and requires further evaluation.
Another possible explanation for the modest symptom improvement observed in our case series is post SG changes. The patients in our series had a substantially longer interval between SG and MSA compared to those in other studies. This prolonged exposure to the iatrogenic increase in intragastric pressure, resulting from the reduced volume of the sleeved stomach, may lead to esophageal dilatation and subsequently ineffective esophageal motility [31]. Furthermore, esophageal dilatation may contribute to acid pooling in the esophagus. Further research is needed to determine the optimal timing of MSA implantation after SG.
Several mechanisms have been proposed to explain the increased risk of gastroesophageal reflux after SG. One possible cause is the disruption of the anatomical anti‐reflux barrier due to widening of the angle of His and resection of the gastric sling fibers [32]. To preserve this natural barrier, careful dissection at the angle of His is essential to spare the sling fibers and avoid blunting the angle, as these fibers are frequently transected near the angle of His during sleeve creation. Another proposed mechanism is the increase in intragastric pressure resulting from a smaller gastric reservoir, reduced compliance, and a narrowed sleeve [33]. This risk can be minimized by ensuring appropriate sleeve size, avoiding the use of a small bougie, refraining from suturing with overly large bites along the staple line, preventing sleeve twisting, avoiding excessive retention of the posterior fundus, and ensuring that the gastric body and pylorus are not overly narrowed.
5. Limitations
This study is not without limitations. First, the case series includes a small sample size, and its retrospective design may introduce selection bias. The authors acknowledge the absence of a standardized decision algorithm for MSA as a limitation of this study. Given the small sample size, the authors felt that proposing a formal decision flowchart would risk overinterpretation. Additionally, the majority of the included studies reported only postoperative clinical outcomes (such as symptom improvement and PPI usage), without providing objective data such as endoscopy, HRM, or pH‐impedance testing. Notably, symptoms have been shown to lack correlation with endoscopic findings [34]. This suggests that relying solely on symptom‐based clinical follow‐up may not be a reliable method for detecting gastroesophageal reflux after SG. Objective diagnostic tools, such as endoscopy, should therefore be considered in the postoperative evaluation of SG patients. Furthermore, most of the studies originated from the United States, which may limit the generalizability of the findings to other regions. Lastly, all included studies were of low‐level evidence, highlighting the need for cautious interpretation. Well‐designed randomized controlled trials with long‐term follow‐up are still needed to definitively establish the role of MSA in patients with gastroesophageal reflux following SG.
6. Conclusion
While the scoping review suggested that MSA may lead to symptomatic improvement in selected patients with gastroesophageal reflux following SG, this is based on low‐level evidence. Our case series showed that only modest symptom improvements were observed following MSA for the treatment of reflux after SG in the Asian population. Future randomized controlled trials with long‐term follow‐up are needed to definitively establish its role in this patient population.
Author Contributions
All authors are in agreement with the content of the manuscript. Marcus Yeow: study conception and design, acquisition of data, analysis and interpretation of data, drafting of manuscript, critical revision of manuscript. Jimmy Bok Yan So: study conception and design; Critical revision of manuscript. Javis Fung: study conception and design, acquisition of data, critical revision of manuscript. Daryl Kai Ann Chia: study conception and design, analysis and interpretation of data, drafting of manuscript, critical revision of manuscript. Asim Shabbir: study conception and design, Drafting of manuscript, Critical revision of manuscript.
Funding
The authors have nothing to report.
Conflicts of Interest
The authors declare no conflicts of interest.
Supporting information
Data S1: GERD‐health related quality of life questionnaire (GERD‐HRQL).
Data S2: Modified demeester score for symptoms of gastroesophageal reflux.
Data S3: Search strategy.
Data Availability Statement
The data that support the findings of this study are available from the corresponding author upon reasonable request.
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Associated Data
This section collects any data citations, data availability statements, or supplementary materials included in this article.
Supplementary Materials
Data S1: GERD‐health related quality of life questionnaire (GERD‐HRQL).
Data S2: Modified demeester score for symptoms of gastroesophageal reflux.
Data S3: Search strategy.
Data Availability Statement
The data that support the findings of this study are available from the corresponding author upon reasonable request.