| Coverage Policy Manual | |
| Policy #: | 2012053 |
| Category: | Surgery |
| Initiated: | August 2012 |
| Last Review: | January 2024 |
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| Gastroesophageal Reflux Disease (GERD), Magnetic Esophageal Ring | |
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| 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 maximum medical therapy.
Background
Gastroesophageal reflux disease (GERD) is defined as reflux of stomach acid into the esophagus that causes symptoms and/or mucosal injury. GERD is a common medical disorder, with estimates of 10-20% prevalence in developed countries. The severity of GERD is widely variable. Many patients have mild, intermittent symptoms that do not require treatment or only require episodic use of medications. Other patients have chronic, severe GERD that can lead to complications such as Barrett’s esophagus and esophageal cancer. For patients with severe disease, chronic treatment with acid blockers is one option. For some patients, medications are not adequate to control symptoms, and other patients prefer to avoid the use of indefinite, possibly lifelong medications. Surgical treatments are available for these patients, 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.
The LINX™ Reflux Management System (Torax Medical) 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. The target population is patients who have GERD symptoms despite maximum medical therapy (e.g., proton pump inhibitors) but who do not want to risk the adverse effects of a surgical procedure like Nissen fundoplication. Adverse events of the LINX™ Reflux Management System may include dysphagia or odynophagia. The device can be removed by a laparoscopic procedure if severe adverse events occur or if magnetic resonance imaging (MRI) is needed for another condition.
Regulatory Status
In 2012, the LINX® Reflux Management System (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 (FDA, 2018). 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" (FDA, 2018).
Coding
Effective in 2017, there are specific CPT category I codes for this procedure:
43284 - Laparoscopy, surgical, esophageal sphincter augmentation procedure, placement of sphincter augmentation device (ie, magnetic band), including cruroplasty when performed
43285 - Removal of esophageal sphincter augmentation device
Effective prior to January 2017
Effective July 1, 2015, there are specific CPT category III codes for this procedure:
0392T - Laparoscopy, surgical, esophageal sphincter augmentation procedure, placement of sphincter augmentation device (ie, magnetic band)
0393T - Removal of esophageal sphincter augmentation device
Prior to 2015, there was no specific CPT code for this procedure. It would probably have been reported with the unlisted laparoscopy procedure, esophagus code 43289.
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Policy/ Coverage: |
Does Not Meet Primary Coverage Criteria Or Is Investigational For Contracts Without Primary Coverage Criteria
The use of an implantable magnetic esophageal ring to treat gastroesophageal reflux disease (GERD) does not meet member benefit certificate primary coverage criteria that there be scientific evidence of effectiveness.
For members with contracts without primary coverage criteria, the use of an implantable magnetic esophageal ring to treat gastroesophageal reflux disease (GERD) is considered investigational. Investigational services are specific contract exclusions in most member benefit certificates of coverage.
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| Rationale: |
Randomized, controlled trials are necessary to establish the efficacy of treatments for gastroesophageal reflux disease (GERD). GERD has a variable natural history, with exacerbations and remissions, and as a result, a control group is required to differentiate improvements in symptoms from the natural history of the disorder. A placebo control is optimal due to the subjective nature of the patient-reported outcome measures, which are prone to bias if the patient is not blinded to treatment assignment. Random assignment is important because of the multiple potential confounders of GERD outcomes, such as diet, smoking and obesity. Randomization minimizes the chance that these confounders will be distributed unequally among treatment groups.
Single-arm series are of limited usefulness for determining treatment efficacy. Improvements in symptoms in single-arm studies may be due to the variable natural history of GERD, and/or bias from the placebo and other non-specific effects. Single-arm series can demonstrate the feasibility and potential benefit of this procedure, and can be used to determine rates of adverse events. It is also important to determine comparative efficacy of treatments for GERD, since there are numerous medical and surgical treatments that are effective. Single-arm series are inadequate for determining comparative effectiveness of different treatment options; controlled trials with active comparators are required for this.
Literature Review
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 with a total of 144 subjects and follow-up data between 2 and 4 years. The feasibility IDE study enrolled 44 subjects at 4 clinical sites (2 U.S. and 2 Europe) and has published data out to 4 years (Bonavina, 2010) (Lipham, 2012). The pivotal IDE study included 100 subjects from 14 clinical sites (13 U.S. and 1 Europe) who had documented symptoms of gastroesophageal reflux disease for longer than 6 months (regurgitation or heartburn that responds to acid neutralization or suppression), required daily proton pump inhibitor (PPI) or other anti-reflux 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. The primary safety endpoint measured the rate of related device and procedure serious adverse events (SAEs). Efficacy endpoints were assessed off PPI therapy and measured esophageal acid exposure, total GERD-Health Related Quality of LIFE (HRQL) scores, and PPI usage. Subjects served as their own controls.
A total of 24/44 (54.5%) subjects in the feasibility study experienced adverse events related to the device and/or procedure, and 2 subjects experienced SAEs. The most common adverse event was dysphagia (22 events in 20 subjects, which resolved in 90 days). No SAEs related to the device or procedure occurred after the first year. In the pivotal study, dysphagia was commonly observed, occurring in 68% of patients (49% mild, 16% moderate, and 5% severe), and an SAE related to the device or implantation procedure occurred in 6% (8/144) of subjects. Most cases of dysphagia self-improved or improved with endoscopic esophageal balloon dilation. Three subjects underwent device removal for severe dysphagia and/or odynophagia. Three subjects were hospitalized for nausea and/or vomiting. One subject reported the inability to vomit. No device migration was observed on radiographs taken at 12 months.
Success on the subject level was defined as normalization of acid (pH <4 for ≤4.5% of time) or reduced total time (pH <4) by at least 50% relative to baseline measurements. In the feasibility study, esophageal pH testing was performed out to 36 months in only 1 of the 4 centers. The percentage of subjects who achieved success was 79.5% (31/39) at 12 months, 90% (18/20) at 24 months, and 85% (17/20) at 36 months. The proportion of patients with reduction in PPI therapy by 50% or more was 89.7% (35/39) at 12 months, 82.9% (29/35) at 24 months, and 87.5% (28/32) at 36 months. Improvement in GERD-HRQL scores by more than 50% occurred in 97.4% (38/39) of subjects at 12 months, 88.6% (31/35) at 24 months and 96.3% (26/27) at 36 months.
In the pivotal study, the primary efficacy endpoint of pH normalization or greater than 50% reduction in acid exposure time when off PPI was met by 64% of the subjects. The mean total acid exposure time was reduced from 11.6% at baseline to 5.1% at 12 months (56% reduction). The secondary efficacy endpoints met the study success criteria. Ninety-two percent of subjects had at least a 50% improvement in GERD-HRQL symptom score (the mean GERD-HRQL total score decreased from 28.4 at baseline to 5.9 and 5.5 at 12 and 24 months, respectively), and 93% had reduced PPI use (79% and 83% of subjects were free from daily dependence at 12 and 24 months, respectively, compared with 0% at baseline). Normal swallow function was reported in 97% of patients, and no dysphagia was reported in the 3 patients with abnormal swallow function.
Ongoing Clinical Trials
A search of the online site www.clinicaltrials.gov in July 2012 identified an industry-sponsored observational study of the LINX® Reflux Management System (NCT01624506). This is a registry to track and monitor patients treated with either the LINX® device or fundoplication in clinical practice. It began in 2010 and has an estimated enrollment of 800 patients, with completion anticipated in 2016.
Summary
A laparoscopically-implanted magnetic esophageal ring is being evaluated for the treatment of GERD. Current evidence consists of 2 uncontrolled and unblinded manufacturer-sponsored studies that were submitted to the FDA for device approval. These single-arm series are of limited usefulness for determining treatment efficacy and provide no information on the comparative efficacy of this procedure with other GERD treatments. The subjective outcome measures used in these two trials, such as the GERD-HRQL, may be biased due to placebo effects with this study design. The objective measure of esophageal pH shows modest improvement compared to baseline, but this is a physiologic measure with uncertain clinical significance. Dysphagia was common in treated patients, although serious adverse events were less common, and the smaller feasibility study did not identify any serious safety concerns at up to 4 years of follow-up. The FDA has required 4 years of follow-up on the 100 subjects in the pivotal study. Independent assessment of the device by non-industry sources would also allow greater certainty. The evidence at this time is insufficient to permit conclusions concerning the effect of this device on net health outcome.
2013 Update
A literature search revealed two new publications evaluating the use of the LINX Reflux system.
In 2013, Ganz and colleagues published results of a prospective, non-controlled study of 100 patients with gastroesophageal reflux disease treated with sphincter augmentation with magnetic beads. The primary outcome was normalization of esophageal acid exposure or 50% or greater reduction in exposure at 1 year. The primary outcome was achieved in 64% of patients. A 50% or more reduction in proton-pump inhibitors occurred in 93% of patients. The most common adverse event, dysphagia occurred in 68% of patients postoperatively. Serious adverse events occurred in six patients, requiring removal of the device. The authors conclude, “Studies with larger samples and longer-term follow-up are need to confirim these early results and assess longer-term safety”.
In a recently published guideline on the diagnosis and management of gastroesophageal reflux disease (Katz, 2013), in a brief discussion of the LINX Reflux system, the author states “More data are required before widespread usage can be recommended”.
There remains insufficient evidence to permit conclusion regarding the effect of treatment with this device on health outcomes. The policy statement is unchanged.
2014 Update
A literature search conducted through February 2014 did not reveal any new information that would prompt a change in the coverage statement. The key identified literature is summarized below.
Results of the pivotal trial were published in 201 (Ganz, 2013). In this study, the primary efficacy endpoint of pH normalization or greater than 50% reduction in acid exposure time when off PPI was met by 64% of the subjects. The mean total acid exposure time was reduced from 11.6% at baseline to 5.1% at 12 months (56% reduction). The secondary efficacy endpoints met the study success criteria. Ninety-two percent of subjects had at least a 50% improvement in GERD-HRQL symptom score (the mean GERD-HRQL total score decreased from 28.4 at baseline to 5.9 and 5.5 at 12 and 24 months, respectively), and 93% had reduced PPI use (79% and 83% of subjects were free from daily dependence at 12 and 24 months, respectively, compared with 0% at baseline). Dysphagia was observed in 68% of patients postoperatively, in 11% at 1 year, and in 4% at 3 years. Nineteen patients underwent esophageal dilation for dysphagia. Six patients (6%) experienced a serious adverse event (SAE) including severe dysphagia and vomiting. The device was removed in 4 of these 6 patients with a SAE and in 2 additional patients for persistent reflux and chest pain.
2015 Update
A literature search conducted using the MEDLINE database, conducted through February 2015, revealed no new literature that would prompt a change in the coverage statement. The following is a summary of the key identified literature.
Two retrospective comparative studies have been identified on magnetic sphincter augmentation (MSA) with the LINX® device compared with laparoscopic Nissen fundoplication (LNF). Louie at al compared outcomes from 34 patients who had MSA with 32 patients who underwent LNF (Louie, 2014). Similar improvements were found for the 2 groups on the GERD-HRQL scale. The DeMeester score and pH normalized in both groups, but these were lower (p=0.001) in the fundoplication group. MSA allowed belching in 67% of patients compared with none in the fundoplication group. Sheu et al compared outcomes from 12 MSA patients with a contemporaneous case-matched cohort of patients who underwent LNF (Sheu, 2014). Over half of the MSA patients were self-referred, compared with none of the patients who underwent LNF. Both procedures were effective for reflux. Severe dysphagia requiring endoscopic dilation was more frequent after MSA (50% of cases), while there was a trend for a reduction in bloating, flatulence, and diarrhea in this small retrospective study.
In 2014, Lipham et al reported on adverse events for the first 1048 implanted patients (82 institutions) (Lipham, 2014). Of these, 144 were implanted as part of premarket clinical trials (described above), 332 had been enrolled in a postmarket registry, and 572 were implanted outside of a postmarket registry. The 3 sources that were used to identify adverse events were the published clinical literature along with the device’s Summary of Safety Effectiveness Data, the FDA database for device-related complications (MAUDE database), and information provided by the manufacturer. Event rates were 0.1% intra-/perioperative complications, 1.3% hospital readmissions, 5.6% endoscopic dilations, and 3.4% reoperations for device removal. The primary reason for device removal was dysphagia. Erosion of the device occurred in 1 patient (0.1%). The median device implantation was 274 days. This study is limited by the short follow-up and the voluntary reporting of adverse events outside of the registry.
Practice Guidelines and Position Statements
In 2013, the Society of American Gastrointestinal and Endoscopic Surgeons (SAGES) published a Technology and Value Assessment guideline on the safety and effectiveness of the LINX Reflux Management System (SAGES, 2013). SAGES Technology and Value Assessment Committee stated that safety analyses of the LINX system suggests the procedure is associated with few serious adverse events and no reported mortality, and that currently available data demonstrates a reasonable assurance as to the efficacy of the LINX Reflux Management System. The committee concluded that direct comparative studies between the LINX procedure and Nissen fundoplication will be needed, although based on the available evidence the LINX device should be an option available to patients and providers for the management of medically refractory GERD.
A 2013 report on emerging technology from the American Society for Gastrointestinal Endoscopy concluded that long-term data about the safety and efficacy of the LINX device are needed (ASGE, 2013). The document indicates that the LINX band is currently being deployed laparoscopically; however, a natural orifice transluminal endoscopic surgery approach could be explored.
2016 Update
A literature search conducted through November 2016 did not reveal any new information that would prompt a change in the coverage statement. The key identified literature is summarized below.
NONRANDOMIZED COMPARATIVE STUDIES
Retrospective comparative studies have been identified on magnetic sphincter augmentation (MSA) with the LINX device compared with laparoscopic Nissen fundoplication (LNF) or laparoscopic Toupet fundoplication (LTF).
The largest study identified is a multi-institutional retrospective cohort study by Warren and colleagues who reported on 415 patients treated with either MSA (n=201) or LNF (n=214) (Warren, 2016). Eligible patients were retrospectively identified from 3 centers’ prospectively collected databases, and met criteria if they had GERD at least partially responsive to proton pump inhibitor (PPI) treatment and positive pH testing. MSA-treated patients had lower DeMeester scores, and lower rates of biopsy-proven Barrett esophagus and hiatal hernia. Given the differences in baseline groups, the authors used propensity score matching to generate 114 matched pairs based on preoperative esophagitis, presence of Barret esophagus, hiatal hernia, and body mass index (BMI). Mean follow-up differed for matched pair MSA and LNF groups (11 mo vs 16 mo, respectively, p<0.001). In quality of life analysis at follow-up, there was no significant difference in match-pair groups in Gastroesophageal Reflux Disease-Health-Related Quality of Life (GERD-HRQL) scores (6 for MSA vs 5 for LNF, p=0.54). The proportion of patients using PPIs at follow-up was higher in the MSA group (24% vs 12%, p=0.02), but more patients in the MSA group had the ability for eructation (97% vs 66%, p<0.001).
Asti and colleagues reported on an observational cohort study comparing MSA (n=135) and LTF (n=103), using patients identified from a prospectively collected database (Asti, 2016). Eligible patients had GERD symptoms despite PPI for at least 6 months, and normal esophageal motility. In a generalized estimating equation model for the GERD-HRQL, there was no significant difference at 1 year in GERD-HRQL scores between MSA and LTF groups (odds ratio [OR] for time-treatment interaction term, 1.04; 95% confidence interval [CI], 0.89 to 1.27; p=0.578). Similarly, there was no significant difference between the MSA and LTF groups at 1 year in PPI use (OR for time-treatment interaction term, 1.18; 95% CI, 0.81 to 1.70; p=0.389).
Five-year results from 33 of the 44 patients from the feasibility IDE trial were published in 2015 (Saino, 2015). For the 33 with follow-up, the mean total GERD-HRQL score decreased from 25.7 at baseline to 2.9 at year 5 (p<0.001); 93.9% had more than 50% reduction in total score versus baseline. On esophageal pH testing, the mean percentage of time that pH was less than 4 decreased from 11.9% at baseline to 4.6% at 5 years (p<0.001). At 5 years, 87.8% had stopped PPIs.
Five-year results for the 100 patients in the pivotal IDE trial were published in 2016 (Ganz, 2016). Eighty-five patients had follow-up at 5 years. Of those 85, 83% achieved had a 50% reduction in GERD-HRQL scores (95% CI 73% to 91%) and 89.4% had a reduction of 50% or more in average daily dose of PPI (95% CI, 81% to 95%). No new major safety concerns emerged. The device was removed in 7 patients.
Additional single-arm observational studies have reported on outcomes after MSA in sample sizes ranging from 121 to 192 patients,(Smith, 2014; Reynolds, 2014; Warren, 2016; Rona, 2016) some of which focused on specific subpopulations of individuals with GERD, such as those with large hiatal hernias (eg, Rona et al, 2016).
2018 Update
A literature search conducted using the MEDLINE database did not identify any new information that would prompt a change in the coverage statement.
2019 Update
Annual policy review completed with a literature search using the MEDLINE database through December 2018. No new literature was identified that would prompt a change in the coverage statement.
2020 Update
Annual policy review completed with a literature search using the MEDLINE database through December 2019. No new literature was identified that would prompt a change in the coverage statement. The key identified literature is summarized below.
Two recent systematic reviews compared MSA to laparoscopic Nissen fundoplication (LNF) in patients with GERD (Guidozzi, 2019; Aiolfi, 2018). Both conducted meta-analyses of comparative observational studies and concluded that MSA and LNF had similar effects on symptoms and QOL. The body of evidence was limited, however, by the retrospective design of most studies and the reviewers concluded that RCT evidence was needed.
There are no RCTs of MSA compared to LNF. There is one open-label RCT comparing MSA to twice-daily omeprazole 20 mg in 152 patients with
regurgitation symptoms despite once daily omeprazole 20 mg. At six6 months, significantly more patients who received MSA reported
improvements in symptoms and QOL than those in the control group. Ninety-one percent of those who received the surgery were able to maintain discontinuation of proton pump inhibitor (PPIs) at six months.
Limitations included the use of subjective outcome measures along with an open-label design. At baseline, more patients in the MSA group had grade B esophagitis (18.4% vs 10.0), and more had a hiatal hernia (58% vs 49%). There were more withdrawals in the PPI group (12.9% vs 0). It is unclear whether twice-daily omeprazole 20mg is an appropriate comparator. Although an increased dose is sometimes recommended, 20 mg twice daily is not a Food and Drug Administration (FDA)-approved dose for patients with GERD
2021 Update
Annual policy review completed with a literature search using the MEDLINE database through December 2020. No new literature was identified that would prompt a change in the coverage statement. The key identified literature is summarized below.
In 2012, the LINX® Reflux Management System (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 (USFDA, 2018).
Alicuben et al published a retrospective review which identified a risk of device erosion of 0.3% at 4 years after device placement (Alicuben, 2018). 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.
Additional single-arm observational studies have reported on outcomes after MSA in sample sizes ranging from 121 to 192 patients, some of which focused on specific subpopulations of individuals with GERD, such as those with large hiatal hernias (Reynolds, 2014; Warren, 2017; Smith, 2014; Rona, 2017; Ferrari, 2020).
For individuals who have GERD who receive magnetic sphincter augmentation (MSA), the evidence includes one randomized controlled trial comparing MSA to proton pump inhibitor therapy, single-arm cohort studies, and systematic reviews of observational studies comparing MSA to laparoscopic Nissen fundoplication. Relevant outcomes are symptoms, change in disease status, medication use, and treatment-related morbidity. A randomized controlled trial comparing MSA to omeprazole 20 mg twice daily found significantly more patients who received MSA reported improvements in symptoms and quality of life at 6 months. A major limitation of the trial was that the patients had not received optimal medical treatment prior to enrollment. In the 2 single-arm, uncontrolled pivotal trials submitted to the U.S. Food and Drug Administration with materials for device approval, subjects showed improvements in GERD-health-related quality of life scores and reduced proton pump inhibitor use. Similarly, observational comparative studies included in systematic reviews, most often comparing MSA with laparoscopic Nissen fundoplication, generally have shown that GERD-health-related quality of life scores do not differ significantly between fundoplication and MSA, and patients can reduce proton pump inhibitor use after MSA. However, the comparative studies are retrospective and nonrandomized, and may be affected by selection bias. Randomized comparisons of MSA with laparoscopic Nissen fundoplication are needed to evaluate the relative risk-benefit of these 2 procedures. The evidence is insufficient to determine the effects of the technology on health outcomes.
2022 Update
Annual policy review completed with a literature search using the MEDLINE database through December 2021. No new literature was identified that would prompt a change in the coverage statement. The key identified literature is summarized below.
Bonavina et al published 3-year outcomes from a prospective, observational registry evaluating MSA and laparoscopic fundoplication in 631 patients (465 MSA; 166 laparoscopic fundoplication) enrolled between 2009-2014 across 22 medical centers in Europe (Bonavina, 2021). 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 Los Angeles 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.
Louie et al published 1-year outcomes from a 5-year FDA-mandated multicenter post-approval study (Louie, 2019). 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.
Ayazi et al published a retrospective review of 380 patients treated with MSA with a mean follow-up duration of 11.5 ± 8.7 months (Ayazi, 2020). 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 79 to 500 patients, 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])(Smith, 2014; Reynolds, 2014; Warren, 2017; Rona, 2017; Ferrari, 2020; Ayazi, 2020; Dunn, 2021). Other studies have highlighted independent predictors of favorable outcomes, such as age of intervention <40-45 years, male sex, abnormal DeMeester scores, and baseline GERD-HRQL scores >15 (Ferrari, 2020; Ayazi, 2020).
FDA Manufacturer and User Facility Device Experience (MAUDE) reports and manufacturer complaint databases were analyzed from 2013-2020 by DeMarchi and coworkers to determine rates of surgical device erosion and explants (DeMarchi, 2021). 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.
2023 Update
Annual policy review completed with a literature search using the MEDLINE database through December 2022. No new literature was identified that would prompt a change in the coverage statement. The key identified literature is summarized below.
Additional single-arm observational studies have reported on outcomes after MSA in sample sizes ranging from 79 to 500 patients, some of which focused on specific subpopulations of individuals with GERD, such as those with large hiatal hernias (e.g., Rona et al [2017] and Dunn et al [2021]) or with prior bariatric and anti-reflux surgery (Leeds et al [2021]) (Smith, 2014; Reynolds, 2014; Warren, 2017; Rona, 2017; Ferrari, 2020; Ayazi, 2020; Dunn, 2021; Bridges, 2022; Leeds, 2021). Other studies have highlighted independent predictors of favorable outcomes, such as age of intervention <40-45 years, male sex, abnormal DeMeester scores, and baseline GERD-HRQL scores >15 (Ferrari, 2020; Ayazi, 2020).
Fletcher et al 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 (Fletcher, 2021). 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).
In January 2022, the American College of Gastroenterology (ACG) published a clinical guideline on the diagnosis and management of GERD (Katz, 2022). Relevant recommendations concerning surgical management of refractory GERD include:
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."
2024 Update
Annual policy review completed with a literature search using the MEDLINE database through December 2023. No new literature was identified that would prompt a change in the coverage statement. The key identified literature is summarized below.
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 (Kothari, 2021).
There are no RCTs of MSA compared to LNF. There is 1 open-label RCT comparing MSA to twice-daily omeprazole 20 mg in152 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 (Bell, 2020).
Data was published from an observational, retrospective cohort study comparing MSA and laparoscopic Toupe fundoplication (LTF) in patients with refractory GERD at a single tertiary-care center in Italy (Asti, 2023). Patients underwent laparoscopic anti reflux surgery for GERD and/or large hiatal hernias from January 2014 to December 2021 in 199 patients [130 MSA; 69toupet 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.
A retrospective review of a prospective database evaluating patients who underwent LNF, MSA, or anti-reflux mucosectomy (ARMs) was published (Callahan, 2023). 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, 46MSA, 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 (15.4vs 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 2year follow-up, but at 5 years MSA patients had worse GERD-HRQL scores compared to the Toupet fundoplication group (17.8vs 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.
A retrospective cohort study was published 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 (O'Neil, 2023). 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 65months for LNF (range 51 to 85 months) and 68 months for MSA (range 57 to 87 months); 5 patients in the MSA group and 4patients 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 to33% in the LNF group (p=.62). Median GERD-HRQL scores were 9 (interquartile range [IQR], 4-14) in the MSA group and 7.5(IQR, 2.5-14; 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.
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 (AFS, 2022):
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 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 (Khaitan, 2023).
The American Gastroenterological Association (AGA) issued a statement on the personalized approach to evaluating and managing individuals with GERD in 2022 (Yadlapati, 2022). 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."
A multi-society consensus guideline on the treatment of GERD was issued by the 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 (Slater, 2023). 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)
In 2023, the NICE issued an interventional procedure guidance on laparoscopic insertion of a magnetic ring for GERD (NICE, 2023). The following recommendations were based on a comprehensive literature search and review:
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