Medical Policy

Policy Num:      07.001.094
Policy Name:    Magnetic Esophageal Sphincter Augmentation to Treat Gastroespphageal Reflux Disease
Policy ID:          [07.001.094]  [Ac / B / M- / P-]  [7.01.137]

Last Review:      December 12, 2024
Next Review:      December 20, 2025
 

Related Policies:

02.004.005 - Transesophageal Endoscopic Therapies for Gastroesophageal Reflux Disease

Magnetic Esophageal Sphincter Augmentation to Treat Gastroesophageal Reflux Disease

Summary

Description

A laparoscopically implanted ring composed of interlinked titanium beads with magnetic cores has been developed for the treatment of gastroesophageal reflux disease (GERD). The device is placed around the esophagus at the level of the gastroesophageal junction and is being evaluated in patients who have GERD symptoms, despite maximal medical therapy.

Summary of Evidence

For individuals who have GERD who receive magnetic esophageal sphincter augmentation (MSA), the evidence includes 1 RCT comparing MSA to proton pump inhibitor (PPI) therapy, 4 nonrandomized studies comparing MSA to laparoscopic Nissen fundoplication (LNF), laparoscopic Toupet fundoplication (LTF), or anti-reflex mucosectomy (ARM), single-arm cohort studies, and systematic reviews comparing MSA to LNF. Relevant outcomes are symptoms, change in disease status, medication use, and treatment-related morbidity. An RCT comparing MSA to omeprazole 20 mg twice daily found significantly more patients who received MSA reported improvements in symptoms and GERD-related quality of life (QOL) at 6 months. A major limitation of the trial was that the patients had not received optimal medical treatment prior to enrollment. Four non-randomized comparative studies of MSA to laparoscopic fundoplication showed mixed outcomes, with some studies indicating similar improvements in QOL, PPI use, and satisfaction, while others reported no significant differences in symptom improvement but a higher rate of dysphagia in the MSA group, and another study observed transient differences in favor of fundoplication in QOL, with the MSA group having worse QOL scores at final follow-up. Limitations in these comparative studies included a lack of randomization, blinding, heterogeneity in surgical techniques, outdated MSA protocols, imbalanced baseline patient characteristics, and selection bias in treatment choice. In the 2 single-arm, uncontrolled pivotal trials submitted to the FDA with materials for device approval, subjects showed improvements in GERD-health related QOL (GERD-HRQL) scores and reduced PPI use. Similarly, observational comparative studies included in systematic reviews, most often comparing MSA with LNF, generally have shown that GERD-HRQL scores do not differ significantly between fundoplication and MSA, and patients can reduce PPI use after MSA. However, the comparative studies are retrospective and nonrandomized, and may be affected by selection bias. Randomized comparisons of MSA with LNF are needed to evaluate the relative risk-benefit of these 2 procedures. The evidence is insufficient to determine that the technology results in an improvement in the net health outcome.

Additional Information

Not applicable.

Objective

The objective of this evidence review is to determine the efficacy of magnetic sphincter augmentation in the treatment of gastroesophageal reflux disease compared with alternative treatments.

Policy Statements

Magnetic esophageal sphincter augmentation to treat gastroesophageal reflux disease is investigational.

Policy Guidelines

Coding

See the Codes table for details.

Benefit Application

BlueCard/National Account Issues 

State or federal mandates (eg, Federal Employee Program) may dictate that certain U.S. Food and Drug Administration approved devices, drugs, or biologics may not be considered investigational, and thus these devices may be assessed only by their medical necessity.

Benefits are determined by the group contract, member benefit booklet, and/or individual subscriber certificate in effect at the time services were rendered.  Benefit products or negotiated coverages may have all or some of the services discussed in this medical policy excluded from their coverage.

Background

Gastroesophageal Reflux Disease

Gastroesophageal reflux disease (GERD) is defined as the reflux of stomach acid into the esophagus that causes symptoms and/or mucosal injury. GERD is a common medical disorder, with estimates of 10% to 20% prevalence in developed countries.

Regulatory Status

In 2012, the LINX^® Reflux Management System (Ethicon; formerly Torax Medical) was approved by the U.S. Food and Drug Administration (FDA) through the premarket approval process (P100049) for patients diagnosed with GERD, as defined by abnormal pH testing, and who continue to have chronic GERD symptoms despite maximal therapy for the treatment of reflux. The FDA initially required a 5-year follow-up of 100 patients from the investigational device exemption pivotal study to evaluate the safety and efficacy of the device, which was completed in March 2016. In 2018,the manufacturer initiated a device recall due to a possible separation of the bead component with the adjacent wire link causing a potential discontinuous or open LINX device.^1,This recall was terminated on November 4, 2020. FDA product code: LEI.

In March 2018, the FDA approved an update of the LINX^® Reflux Management System precautions statement, stating that the use of the system "in patients with a hiatal hernia larger than 3 cm should include hiatal hernia repair to reduce the hernia to less than 3 cm and that the LINX Reflux Management System has not been evaluated in patients with an unrepaired hiatal hernia greater than 3 cm, add a hiatal hernia clinical data summary in the instructions for use, update the instructions for use section to highlight the recommendation to repair a hiatal hernia, if present, at the time of the LINX Reflux Management System implantation, and update the patient information booklet to align with the instructions for use and include 5 year clinical study results."^2,

In February 2024, the FDA revised the labeling for the LINX® Reflux Management System. They removed a precautionary statement about Barrett's Esophagus (BE) from the instructions for use. However, the updated labeling now includes this guidance: "LINX has not been proven to effectively treat BE by causing regression or preventing progression to cancer. Patients with BE who use LINX to manage GERD symptoms should consult their physician about ongoing BE treatment, which may include continued use of proton pump inhibitors (PPIs)."^3,

Rationale

This evidence review was created in August 2012 and has been updated regularly with searches of the PubMed database. The most recent literature update was performed through September 23, 2024.

Evidence reviews assess the clinical evidence to determine whether the use of technology improves the net health outcome. Broadly defined, health outcomes are the length of life, quality of life (QOL), and ability to function, including benefits and harms. Every clinical condition has specific outcomes that are important to patients and managing the course of that condition. Validated outcome measures are necessary to ascertain whether a condition improves or worsens; and whether the magnitude of that change is clinically significant. The net health outcome is a balance of benefits and harms.

To assess whether the evidence is sufficient to draw conclusions about the net health outcome of technology, 2 domains are examined: the relevance, and quality and credibility. To be relevant, studies must represent 1 or more intended clinical use of the technology in the intended population and compare an effective and appropriate alternative at a comparable intensity. For some conditions, the alternative will be supportive care or surveillance. The quality and credibility of the evidence depend on study design and conduct, minimizing bias and confounding that can generate incorrect findings. The randomized controlled trial (RCT) is preferred to assess efficacy; however, in some circumstances, nonrandomized studies may be adequate. Randomized controlled trials are rarely large enough or long enough to capture less common adverse events and long-term effects. Other types of studies can be used for these purposes and to assess generalizability to broader clinical populations and settings of clinical practice.

Promotion of greater diversity and inclusion in clinical research of historically marginalized groups (e.g., People of Color [African-American, Asian, Black, Latino and Native American]; LGBTQIA (Lesbian, Gay, Bisexual, Transgender, Queer, Intersex, Asexual); Women; and People with Disabilities [Physical and Invisible]) allows policy populations to be more reflective of and findings more applicable to our diverse members. While we also strive to use inclusive language related to these groups in our policies, use of gender-specific nouns (e.g., women, men, sisters, etc.) will continue when reflective of language used in publications describing study populations.

Clinical Context and Therapy Purpose

The purpose of magnetic sphincter augmentation (MSA) in individuals who have gastroesophageal reflux disease (GERD) is to provide a treatment option that is an alternative to or an improvement on existing therapies.

The following PICO was used to select literature to inform this review.

Populations

The relevant population of interest is individuals with GERD who have not responded to optimal medical management.

The severity of GERD varies widely. Many individuals have mild, intermittent symptoms that do not require treatment or only require episodic use of medications. Other individuals have chronic, severe GERD that can lead to complications such as Barrett esophagus and esophageal cancer.

The Los Angeles (LA) classification system is used to describe the endoscopic appearance of reflux esophagitis and grade its severity. Esophagitis is confirmed by endoscopy according to a 5 grading severity scale.

• Not present: No breaks (erosions) in the esophageal mucosa (edema, erythema, or friability may be present).

• Grade A: One or more mucosal breaks confined to the mucosal folds, each not more than 5 mm in maximum length.

• Grade B: One or more mucosal breaks more than 5 mm in maximum length, but not continuous between the tops of 2 mucosal folds.

• Grade C: Mucosal breaks that are continuous between the tops of 2 or more mucosal folds, but which involve less than 75% of the esophageal circumference.

• Grade D: Mucosal breaks which involve at least 75% of the esophageal circumference.

Interventions

The therapy being considered is MSA. The LINX Reflux Management System is composed of a small flexible band of 10 to 18 interlinked titanium beads with magnetic cores. Using standard laparoscopic techniques, the band is placed around the esophagus at the level of the gastroesophageal junction. The magnetic attraction between the beads is intended to augment the lower esophageal sphincter to prevent gastric reflux into the esophagus, without compressing the esophageal wall. It is proposed that swallowing food or liquids creates sufficient pressure to overcome the magnetic bond between the beads, allowing the beads to separate and temporarily increase the size of the ring. Magnetic sphincter augmentation is a 30-minute surgical procedure performed under general anesthesia that includes testing of the esophageal sphincter. This is a minimally invasive procedure conducted in an inpatient surgical center and requires an overnight stay. The device manufacturer claims individuals resume a normal diet within 24 hours postsurgery. The device can be removed by a laparoscopic procedure if severe adverse events occur or if magnetic resonance imaging is needed for another condition.

Comparators

The following therapies and practices are currently being used to treat GERD that has not responded to optimal medical therapy: lifestyle modifications, continued medical therapy, and interventions to strengthen the lower esophageal sphincter.

Lifestyle modifications may include weight loss, elevation of the head of the bed, avoidance of meals close to bedtime, and elimination of dietary triggers. For patients with severe disease, chronic treatment with acid suppressive therapies is an option. For some individuals, medications are inadequate to control symptoms; other individuals prefer to avoid the use of indefinite, possibly lifelong medications. Surgical treatments are available for these individuals, primarily a Nissen fundoplication performed either laparoscopically or by open surgery. A number of less invasive procedures are also being evaluated as an intermediate option between medical therapy and surgery (see review 2.01.38 on endoscopic procedures).

In individuals who continue to have symptoms despite once daily proton pump inhibitors (PPIs) (e.g., omeprazole 20 mg), guideline based recommendations include increasing and/or splitting the PPI dose, and switching to a different PPI to optimize pharmacologic treatment.

Outcomes

Relevant outcomes of interest are a reduction in symptoms such as heartburn and regurgitation, reduction in acid suppression medication use, QOL, treatment-related adverse events, device failure, device erosion, the need to explant if magnetic resonance imaging is necessary, and progression to Barrett esophagus and esophageal cancer. Additional outcomes of interest include objective measures such as the DeMeester score or percent time esophageal pH < 4 based on impedence-pH findings. Objective measures are of special interest as a lack of correlation between subjective and objective measures of GERD have been reported in the literature.^4,

A variety of scales have been developed to measure patient and investigator-reported GERD symptoms. Frequently used measures of QOL include the GERD-health-related QOL (GERD-HRQL), a scale with 11 items focusing on heartburn symptoms, dysphagia, medication effects, and the individual's present health condition. Each item is scored from 0 to 5, with a higher score indicating a better QOL, and GERD-QOL, a scale with 16 items clustered into the following 4 subscales: daily activity, treatment effect, diet, and psychological well-being. The total score of this questionnaire is the average of the 4 subscale scores. The final score can range from 0 to 100, with a higher score indicating a better QOL.

Study Selection Criteria

Methodologically credible studies were selected using the following principles:

• To assess efficacy outcomes, comparative controlled prospective trials were sought, with a preference for RCTs;

• In the absence of such trials, comparative observational studies were sought, with a preference for prospective studies.

• To assess long-term outcomes and adverse events, single-arm studies that capture longer periods of follow-up and/or larger populations were sought.

• Studies with duplicative or overlapping populations were excluded.

Review of Evidence

Systematic Reviews

Four systematic reviews compared MSA to laparoscopic Nissen fundoplication (LNF) in patients with GERD (Table 1).^5,6,7,8, Three meta-analyses of concluded that MSA and LNF had similar effects on symptoms and QOL and one meta-analysis found superior reductions in need for a PPI, GERD-HRQL, and post-operative dysphagia (Table 2). However, the body of evidence was limited by the retrospective design of most studies, and the reviewers generally concluded that RCT evidence was needed.

Table 1. Characteristics of Systematic Reviews of Magnetic Sphincter Augmentation Compared to Laparoscopic Nissen Fundoplication

Table 2. Results of Systematic Reviews of Magnetic Sphincter Augmentation Compared to Laparoscopic Nissen Fundoplication

Randomized Controlled Trial

There are no RCTs of MSA compared to LNF. There is 1 open-label RCT comparing MSA to twice-daily omeprazole 20 mg in 152 patients with regurgitation symptoms despite once daily omeprazole 20 mg (Table 3). The primary endpoint was the percentage of patients who achieved elimination of moderate-to-severe regurgitation at 6 months, as reported by patients on the Foregut Symptom Questionnaire. The Foregut Symptom Questionnaire evaluates the severity of regurgitation symptoms: none, mild (after straining or large meals), moderate (predictable with position change, lying down, straining), and severe (constant). Esophageal reflux parameters (number of reflux episodes and percentage of time with pH <4 and PPI use were secondary endpoints. At 6 months, significantly more patients who received MSA reported improvements in symptoms and QOL than those in the control group (Table 4). Ninety-one percent of those who received the surgery were able to maintain discontinuation of PPIs at 6 months. Patients who received MSA testing had less reflux, as measured by impedance-pH testing. Follow-up in randomized arms continued for 6 months after which patients in the medical therapy arm could elect to receive MSA; results for patients who crossed over to MSA were similar to those who were randomized to MSA.^10,

The relevance and study design and conduct limitations of the RCT conducted by Bell et al (2020 ) are shown in Tables 5 and 6. A major limitation of the trial was that the patients had not received optimal medical treatment prior to enrollment. Additional limitations included the use of subjective outcome measures along with an open-label design, although this is less of a concern because results were supported by better results for MSA on some objective measures (Table 4). For patients who have not responded to optimal medical treatment, an appropriate comparator would be Nissen fundoplication.

Table 3. Summary of Key Randomized Controlled Trial Characteristics

Table 4. Summary of Key Randomized Controlled Trial Results

Table 5. Study Relevance Limitations

Table 6. Study Design and Conduct Limitations

Nonrandomized Comparative Studies

Bonavina et al (2021) published 3-year outcomes from a prospective, observational registry evaluating MSA and laparoscopic fundoplication in 631 patients (465 MSA; 166 laparoscopic fundoplication) enrolled between 2009 and 2014 across 22 medical centers in Europe.^12, Patients had a diagnosis of GERD confirmed by abnormal esophageal acid exposure and chronic reflux symptoms despite daily use of PPIs. Patients with severe GERD marked by hiatal hernia >3 cm, Barrett esophagus, motility disorder, and Grade C or D esophagitis by LA classification were also included. The type of anti-reflux procedure performed was provisionally determined by the surgeon in consultation with the patient. MSA was recommended when patients met labeling requirements for MSA (hiatal hernia ≤ 3 cm, esophagitis < Grade C, absence of Barrett esophagus, and absence of motility disorders); however, the final choice of procedures was made by the surgeon at the time of laparoscopy. Various forms of laparoscopic fundoplication were performed, including Nissen (62%), Toupet (31%), and Other/Unspecified (eg, Dor; 7%). Improvements in total GERD-HRQL scores were observed in both MSA (22.0 to 4.6) and laparoscopic fundoplication (23.6 to 4.9) groups with similar increases in GERD-HRQL satisfaction. A higher proportion of patients maintained the ability to vomit in the MSA group compared to laparoscopic fundoplication (91.2% vs. 68.0%). Similar declines in PPI usage were observed in both groups (MSA 97.8% to 24.2% and laparoscopic fundoplication 95.8% to 19.5%). Limitations of the study include lack of randomization and blinding, heterogeneity in laparoscopic fundoplication techniques, and selection bias as patients with less severe symptoms received MSA. It is unclear to what extent study results are generalizable to U.S. populations and broader settings of care. Additionally, the minimal dissection protocol for MSA implantation utilized in this study has since evolved to include full crural and gastroesophageal junction dissection.

Asti et al (2023) published data from an observational, retrospective cohort study comparing MSA and laparoscopic Toupet fundoplication (LTF) in patients with refractory GERD at a single tertiary-care center in Italy.^13, Patients underwent laparoscopic antireflux surgery for GERD and/or large hiatal hernias from January 2014 to December 2021 in 199 patients [130 MSA; 69 toupet fundoplication). All patients included had persistent GERD symptoms despite PPI therapy for at least 6 months with abnormal acid exposure at the time of esophageal pH monitoring and initial hernia < 3cm. Patients with previous esophageal or gastric surgeries were excluded. Both groups had a median follow-up time of 12 months. The morbidity rate in the MSA group was 0.8% and 2.9% after LTF, with no post-operative deaths in either group. A significant decrease in GERD-HRQL score was noted in both patient groups (p<.001), but when adjusted for age, sex, and baseline GERD scores no significant differences in the change from baseline were observed between groups (-12.39 in LTF vs. -15.47 in MSA; p=.73). Patients in the MSA group had a greater incidence of grade > 2 dysphagia (35.5%) compared to the LTF group (7.7%; p=.0009). No significant differences were observed in the rate of severe or persistent bloating between groups (12.9% LTF vs. 35.9% in MSA; p=.7604) or continued PPI therapy (21.9% LTF vs. 18.7% in MSA; p=.6896). Limitations of the study include lack of randomization and blinding and imbalance of baseline patient characteristics including GERD-HREQL score, duration of PPI therapy, hernia size, gender and age. It is unclear to what extent study results are generalizable to U.S. populations and broader care settings.

Callahan et al (2023) published a retrospective review of a prospective database evaluating patients who underwent LNF, MSA, or anti-reflux mucosectomy (ARMs).^14, Patients were followed up at 3 weeks, 6 months, 1 year, 2 years, and 5 years post-operation. A total of 649 patients had reflux surgery during the study period from 2008 to 2021 including 356 LNF, 207 LTF, 46 MSA, and 40 ARMs procedures. These groups were imbalanced on several baseline characteristics including age, BMI, gender, hypertension medication usage, pre-operative dysphagia, esophageal motility, and hernia type. Procedure time was significantly shorter in patients treated with MSA or ARM compared to fundoplication (p<.001). At 3 weeks follow-up patients in the MSA group had higher reflux symptoms index scores and GERD-HRQL scores than patients in the Toupet fundoplication group (15.4 vs 9.5; p=.044 and 9.6 vs 4.8; p=.043, respectively), but these differences had resolved by 6 months with all four treatment groups showing similar outcomes. One-year follow-up data on GERD-HRQL showed a significant difference between the MSA group and ARM groups with the MSA group having worse symptoms (6.9 vs 2.5; p=.048); this difference was not observed at 2 year follow-up, but at 5 years MSA patients had worse GERD-HRQL scores compared to the Toupet fundoplication group (17.8 vs 4.9; p=.024). All groups had similar scores at all time points follow-up for gas bloating and dysphagia symptoms. Limitations of the study include lack of randomization and blinding, imbalance of baseline patient characteristics, and changes in secular trends over the study period which resulted in predominantly younger patients with normal manometry receiving LNF.

O'Neil et al (2023) published a retrospective cohort study of patients undergoing MSA (n=25) compared to LNF (n=45) for the management of symptomatic GERD from a single center from 2013 to 2015 with the intent of comparing long-term follow-up outcomes at 5 years.^15, At baseline, patients were imbalanced on gender, with LNF having more females, BMI with LNF patients being more overweight, and baseline GERD-HRQL scores with LNF having worse symptoms. In the short term, both groups experienced improvements in GERD-HRQL and gastroesophageal reflux symptom scale (GERSS) scores and reductions in PPI usage from baseline levels, but no significant between-group differences were observed. The median long-term follow-up was 65 months for LNF (range, 51 to 85 months) and 68 months for MSA (range, 57 to 87 months); 5 patients in the MSA group and 4 patients in the LNF group did not have long-term outcomes reported. At the last available follow-up, between-group comparisons of outcomes were equivalent for all reported outcomes. Patients in the MSA group had a rate of PPI use of 40% compared to 33% in the LNF group (p=.62). Median GERD-HRQL scores were 9 (interquartile range [IQR], 4 to 14) in the MSA group and 7.5 (IQR, 2.5 to 14; p=.068) in the LNF group; median overall GERSS scores also did not vary significantly (10 vs 11; p=.89). Rates of revision were 20% in the MSA group and 7% in the LNF group (p=.32). A within-group longitudinal comparison of pre-operative, to post-operative, and long-term follow-up values showed both groups had significant reductions in PPI usage, improvements in GERD-HRQL, and GERSS overall scores (p<.01). Limitations of the study include lack of randomization and blinding as well as an imbalance of baseline patient characteristics.

Wisniowski et al (2024) published a retrospective analysis of the American College of Surgeons National Surgical Quality Improvement Program Registry comparing MSA (n=597) and fundoplication (n=7285) in 7,882 patients who underwent surgery between 2017 and 2020.^16, MSA patients were younger (51 vs. 57 years; p<.001), more often male (49.6% vs 34.3%; p<.001), and had fewer medical comorbidities. MSA was associated with shorter operative time (80.8 vs. 118.7 min; p<.001), hospital length of stay (0.4 vs. 1.8 days; p<.001), and rate of readmissions (2.2% vs. 4.7%; p=.005). No differences were observed in the rate of re-operation (1% vs. 2%; p=.095). Postoperative outcomes favored MSA, with lower rates of pneumonia (0.2% vs. 1.0%; p=.044), urinary tract infections (0.0% vs. 0.9%; p=.009), readmissions (2.2% vs. 4.7%; p=.005), and overall complications (0.6% vs. 4.0%; p<.001). Multivariable analysis confirmed these findings, showing MSA independently associated with reduced complications, readmissions, operative time, and length of stay. Limitations include lack of randomization, potential differences in surgical techniques between centers, and the inability to distinguish between partial and Nissen fundoplication in the database. Additionally, the study was limited to 30-day outcomes and lacked data on long-term GERD-specific outcomes and quality of life measures.

Ibach et al (2024) conducted a retrospective, propensity-score matched analysis comparing MSA (n=141) and LNF (n=141) in 282 patients who underwent surgery between 2015 and 2020 at a single center in Germany.^17, All patients had medical treatment-resistant GERD due to hiatal hernia and underwent hiatoplasty. Patients with severe preoperative dysphagia or motility disorders were excluded. At a mean follow-up of 3.9 years, MSA was associated with a lower risk of surgical revision compared to fundoplication (1.2% vs. 3.0% per year; hazard ratio [HR] 0.38, 95% CI 0.15 to 0.96; p=.04) and similar risk of PPI reuptake (2.6% vs. 4.2% per year; p=.12). MSA patients experienced a similar rate of overall adverse events compared to LNF (24% vs. 33%; p=.11), but had significantly lower rates of self-limiting dysphagia (1% vs. 9%; p<.01). However, MSA patients had higher rates of dysphagia requiring endoscopy or surgical revision (13% vs. 9%; p=.44). The MSA device explantation rate was 4%. Limitations include the retrospective design, lack of randomization, potential selection bias in treatment assignment, and the single-center nature of the study.

Single-Arm Studies

Data submitted to the U.S. Food and Drug Administration (FDA) for the LINX Reflux Management System included 2 single-arm FDA regulated investigational device exemption (IDE) trials (N=144 subjects) and follow-up data between 2 and 4 years.^18, The feasibility IDE trial enrolled 44 subjects at 4 clinical sites (2 U.S., 2 Europe) and had published data out to 4 years.^19,20, The pivotal IDE trial included 100 subjects from 14 clinical sites (13 U.S., 1 Europe) who had documented symptoms of GERD for more than 6 months (regurgitation or heartburn that responds to acid neutralization or suppression), required daily PPI or other antireflux drug therapy, had symptomatic improvement on PPI therapy, and had a total distal ambulatory esophageal pH less than 4 for 4.5% or more of the time when off GERD medications.^21, The primary safety endpoint measured the rate of related device and procedure serious adverse events. Efficacy endpoints were assessed off PPI therapy and measured esophageal acid exposure, total GERD-HRQL scores, and PPI usage. Subjects served as their own controls.

Five-year results for the 100 patients in the pivotal IDE trial were published by Ganz et al (2016).^22, Eighty-five patients had a follow-up at 5 years. Of those 85 patients, 83% achieved a 50% reduction in GERD-HRQL scores (95% confidence interval [CI], 73% to 91%), and 89.4% had a reduction of 50% or more in an average daily dose of PPI (95% CI, 81% to 95%). No new major safety concerns emerged. The device was removed in 7 patients.

Louie et al (2019) published 1-year outcomes from a 5-year FDA-mandated multicenter post-approval study.^23, A total of 200 patients (51% male) with a mean age of 48.5 years were treated with MSA between March 2013 and August 2015. At 1 year, GERD-HRQL score, esophageal pH monitoring, medication use, and safety assessments were available for 91% of patients. The predefined clinically significant primary endpoint of ≥50% improvement in total GERD-HRQL score was attained by 84.3% of patients at 1 year (95% CI, 78.0% to 89.4%). Median scores improved from 26.0 ± 6.5 to 4.0 ± 9.7. Data on esophageal pH monitoring was available in 164 patients, with mean percent time pH < 4 decreasing from 10.0% at baseline to 3.6% at 1 year (p<.001) and 74.4% (95% CI, 67.7% to 81.1%) achieving normal esophageal acid exposure. Overall, 87.4% of patients discontinued PPIs. Post-MSA dilation was required in 13 patients with symptoms of dysphagia at 1-year follow-up. The device was removed in 5 (2.5%) patients and 1 patient presented with device erosion.

Alicubin et al (2018) published a retrospective review, which identified a risk of device erosion of 0.3% at 4 years after device placement. ^24, Twenty-nine reported cases of erosion occurred among 9453 device placements. The median time to erosion was 26 months, and most cases occurred between 1 and 4 years after device placement.

Ayazi et al (2020) published a retrospective review of 380 patients treated with MSA with a mean follow-up duration of 11.5 ± 8.7 months.^25, Persistent dysphagia was reported in 59 (15.5%) patients with 31% requiring at least 1 dilation for dysphagia or chest pain. The overall response rate to dilation was 67%, with 7 (1.8%) patients requiring device removal for dysphagia. Independent predictors of persistent dysphagia included the absence of a large hiatal hernia (p=.035), the presence of preoperative dysphagia (p=.037), and having less than 80% peristaltic contractions on high-resolution impedance manometry (p=.031).

Additional single-arm observational studies have reported on outcomes after MSA in sample sizes ranging from 30 to 500 patients,^{26,19,20,27,28,29,30,31,32,33,34,35,}some of which focused on specific subpopulations of individuals with GERD, such as those with large hiatal hernias (eg, Rona et al [2017] and Dunn et al [2021]) or with prior bariatric and anti-reflux surgery (Leeds et al [2021]).^27,30,36,37, Other studies have highlighted independent predictors of favorable outcomes,^28,29, such as age of intervention <40 to 45 years, male sex, abnormal DeMeester scores, and baseline GERD-HRQL scores >15.

The FDA Manufacturer and User Facility Device Experience (MAUDE) reports and manufacturer complaint databases were analyzed from 2013 to 2020 by DeMarchi and colleagues (2021) to determine rates of surgical device erosion and explants.^38, Overall, 7-year cumulative risk of removal was 4.81% (95% CI, 4.31% to 5.36%), with 2.2% of devices (609/27779) having been reported as removed. Primary reasons for device removal included dysphagia/odynophagia (47.9%), persistent GERD (20.5%), and unknown/other (11.2%). The 7-year cumulative risk of erosion was 0.28% (95% CI, 0.17% to 0.46%), with 27 reports of erosion. Smaller device size was found to be associated with increased removal and erosion rates.

Fletcher et al (2021) published a multicenter retrospective review of 144 patients undergoing dilation for dysphagia after MSA for GERD, reporting 245 dilations at a median time to dilation of 175 days.^39, A second dilation was performed in 67 patients, a third dilation was performed in 22 patients, and 4 or more dilations were performed in an additional 7 patients. Overall, dysphagia prompting dilation after MSA implantation was associated with nearly a 12% risk of device explantation (17 devices).

For individuals who have GERD who receive magnetic esophageal sphincter augmentation (MSA), the evidence includes 1 RCT comparing MSA to proton pump inhibitor (PPI) therapy, 4 nonrandomized studies comparing MSA to laparoscopic Nissen fundoplication (LNF), laparoscopic Toupet fundoplication (LTF), or anti-reflex mucosectomy (ARM), single-arm cohort studies, and systematic reviews comparing MSA to LNF. Relevant outcomes are symptoms, change in disease status, medication use, and treatment-related morbidity. An RCT comparing MSA to omeprazole 20 mg twice daily found significantly more patients who received MSA reported improvements in symptoms and GERD-related quality of life (QOL) at 6 months. A major limitation of the trial was that the patients had not received optimal medical treatment prior to enrollment. Four non-randomized comparative studies of MSA to laparoscopic fundoplication showed mixed outcomes, with some studies indicating similar improvements in QOL, PPI use, and satisfaction, while others reported no significant differences in symptom improvement but a higher rate of dysphagia in the MSA group, and another study observed transient differences in favor of fundoplication in QOL, with the MSA group having worse QOL scores at final follow-up. Limitations in these comparative studies included a lack of randomization, blinding, heterogeneity in surgical techniques, outdated MSA protocols, imbalanced baseline patient characteristics, and selection bias in treatment choice. In the 2 single-arm, uncontrolled pivotal trials submitted to the FDA with materials for device approval, subjects showed improvements in GERD-health related QOL (GERD-HRQL) scores and reduced PPI use. Similarly, observational comparative studies included in systematic reviews, most often comparing MSA with LNF, generally have shown that GERD-HRQL scores do not differ significantly between fundoplication and MSA, and patients can reduce PPI use after MSA. However, the comparative studies are retrospective and nonrandomized, and may be affected by selection bias. Randomized comparisons of MSA with LNF are needed to evaluate the relative risk-benefit of these 2 procedures. The evidence is insufficient to determine that the technology results in an improvement in the net health outcome.

With gastroesophageal reflux disease

Supplemental Information

The purpose of the following information is to provide reference material. Inclusion does not imply endorsement or alignment with the evidence review conclusions.

Practice Guidelines and Position Statements

Guidelines or position statements will be considered for inclusion in ‘Supplemental Information' if they were issued by, or jointly by, a US professional society, an international society with US representation, or National Institute for Health and Care Excellence (NICE). Priority will be given to guidelines that are informed by a systematic review, include strength of evidence ratings, and include a description of management of conflict of interest.

American College of Gastroenterology

In January 2022, the American College of Gastroenterology (ACG) published a clinical guideline on the diagnosis and management of GERD.^40, Relevant recommendations concerning surgical management of refractory GERD include:

• "For patients who have regurgitation as their primary PPI [proton pump inhibitor]-refractory symptom and who have had abnormal gastroesophageal reflux documented by objective testing, we suggest consideration of antireflux surgery or TIF [transoral incisionless fundoplication] (conditional recommendation; low level of evidence).

• We recommend antireflux surgery performed by an experienced surgeon as an option for long-term treatment of patients with objective evidence of GERD, especially those who have severe reflux esophagitis (LA grade C or D), large hiatal hernias, and/or persistent, troublesome GERD symptoms (strong recommendation; moderate level of evidence).

• We recommend consideration of MSA as an alternative to laparoscopic fundoplication for patients with regurgitation who fail medical management (strong recommendation; moderate level of evidence)."

The guideline also notes that due to the paucity of long-term data on MSA outcomes and lack of randomized trials directly comparing MSA with fundoplication, "it is difficult to recommend one over the other at this time."

American Foregut Society

The American Foregut Society (AFS) issued a statement on appropriate patient selection and use of MSA and noted that "patient selection criteria for MSA do not differ in principle from those of any other surgical procedure for reflux disease." Indications for MSA include:^41,

• "Typical GERD symptoms (ie, heartburn, regurgitation) with break-through symptoms, intolerance to medical therapy, and/or unwillingness to take anti-reflux medications long term.

• Regurgitation despite optimized medical therapy and lifestyle modification.

• Extraesophageal symptoms with objective evidence of significant reflux disease (ie, endoscopic evidence of [Los Angeles] Class C or D esophagitis, Barrett's esophagus or positive pH study)."

The statement additionally notes that "MSA candidacy largely mirrors that for laparoscopic fundoplication. Low dysphagia rates for MSA have been found when performed in patients with normal esophageal motility." The AFS also recommends that a full hiatal dissection and cruroplasty be performed prior to implantation of an MSA device.

The AFS Bariatric Committee also issued a statement regarding the concurrent use of MSA at the time of primary bariatric surgery,^42, noting that this practice "violates many basic surgical principles and is not considered judicious use by the American Foregut Society." The statement also notes that prospective trials demonstrating the safety and efficacy of concurrent MSA are needed.

American Gastroenterological Association

The American Gastroenterological Association (AGA) issued a statement on the personalized approach to evaluating and managing individuals with GERD in 2022.^43, The authors provided a best practice recommendation: "In patients with proven GERD, laparoscopic fundoplication and magnetic sphincter augmentation are effective surgical options, and transoral incisionless fundoplication is an effective endoscopic option in carefully selected patients."

Multi-society Consensus Conference

A multi-society consensus guideline on the treatment of GERD was issued by the Society of American Gastrointestinal and Endoscopic Surgeons (SAGES), American Society for Gastrointestinal Endoscopy (ASGE), American Society for Metabolic and Bariatric Surgery (ASMBS), European Association for Endoscopic Surgery (EAES), Society for Surgery of the Alimentary Tract (SSAT), and the Society of Thoracic Surgeons (STS) in 2023.^44, Based on a review of the available evidence the consensus panel determined the following recommendations:

• The panel suggests that adult patients with GERD may be treated with either MSA or Nissen fundoplication based on surgeon and patient shared decision-making. (Conditional recommendation based on very low certainty of evidence)

• The panel suggests that adult patients with GERD may benefit from MSA over continued PPI use. (Conditional recommendation based on moderate certainty of evidence)

National Institute for Health and Care Excellence

In 2023, the NICE issued an interventional procedure guidance on laparoscopic insertion of a magnetic ring for GERD.^45, The following recommendations were based on a comprehensive literature search and review:

• "Evidence on the safety and efficacy of laparoscopic insertion of a magnetic ring for GERD is adequate to support using this procedure provided that standard arrangements are in place for clinical governance, consent, and audit."

• "Patient selection and the procedure should be done by clinicians who have specific training in the procedure and experience in upper gastrointestinal laparoscopic surgery and managing GERD."

U.S. Preventive Services Task Force Recommendations

Not applicable.

Medicare National Coverage

There is no national coverage determination. In the absence of a national coverage determination, coverage decisions are left to the discretion of local Medicare carriers.

Ongoing and Unpublished Clinical Trials

Some currently ongoing and unpublished trials that might influence this review are listed in Table 7.

Table 7. Summary of Key Trials

References

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Codes

Policy History