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Introduction: Biomedical devices implanted transabdominally have gained popularity over the past 50 years in the treatment of gastroesophageal reflux disease, paraesophageal hiatal hernia, and morbid obesity. Device-related foregut erosions (FEs) represent a challenging event that demands special attention owing to the potential of severe postoperative complications and death. Purpose: The aim was to provide an overview of full-thickness foregut injury leading to erosion associated with four types of biomedical devices. Methods: The study was conducted using the Preferred Reporting Items for Systematic Reviews and Meta-Analyses extension for Scoping Reviews (PRISMA-ScR). PubMed, EMBASE, and Web of Science databases were queried until December 31, 2023. Eligible studies included all articles reporting data, management, and outcomes on device-related FE. Results: Overall, 132 articless were included for a total of 1292 patients suffering from device-related FE. Four different devices were included: the Angelchik antireflux prosthesis (AAP) (n = 25), nonabsorbable mesh for crural repair (n = 60), adjustable gastric banding (n = 1156), and magnetic sphincter augmentation device (n = 51). The elapsed time from device implant to erosion ranged from 1 to 480 months. Most commonly reported symptoms were dysphagia and epigastric pain, while acute presentation was reported rarely and mainly for gastric banding. The technique for device removal evolved from more invasive open approaches toward minimally invasive and endoscopic techniques. Esophagectomy and gastrectomy were mostly reported for nonabsorbable mesh FE. Overall mortality was .17%. Conclusions: Device-related FE is rare but may occur many years after AAP, nonabsorbable mesh, adjustable gastric banding, and magnetic sphincter augmentation implant. FE-related mortality is infrequent, however, increased postoperative morbidity and the need for esophagogastric resection were observed for nonabsorbable mesh-reinforced cruroplasty.

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BACKGROUND: Obesity affects more than one-third of Americans and can be treated with bariatric surgery, most commonly sleeve gastrectomy (SG). SG has been shown to increase the incidence of gastroesophageal reflux disease (GERD) in some patients, which can be refractory to medical management. Surgical options for post-SG GERD include magnetic sphincter augmentation (MSA) and subtotal gastrectomy with Roux-en-Y reconstruction (SGRY). A comparative analysis of MSA and SGRY for post-SG GERD was performed to evaluate postoperative outcomes. METHODS: A retrospectively maintained prospectively gathered database from 2018 to 2023 was used to identify patients who underwent MSA or SGRY for the indication of GERD after SG. Differences among patient characteristics; GERD assessments, including the health-related quality of life (HRQL) questionnaire and the reflux symptom index (RSI); and procedure outcomes were collected and analyzed according to surgery type. RESULTS: A total of 92 patients (85 females and 7 males) met the inclusion criteria. The study included 17 patients in the MSA group, 71 patients in the SGRY group, and 4 patients who underwent both procedures. The average preoperative body mass index (BMI) of all patients was 33.3. Compared with patients who underwent MSA, those who underwent SGRY presented with higher BMI (29.4 vs 34.2, respectively; P = .013), preoperative GERD-HRQL (35 vs 52, respectively; P = .046), and RSI (14 vs 28, respectively; P = .017). Postoperatively, patients who underwent SGRY demonstrated a higher decrease in mean postoperative DeMeester score than those who underwent MSA (44.2 vs 13.9, respectively; P = .040), with 22 patients (50%) in the SGRY group vs 10 patients (20%) in the MSA group achieving normalization. CONCLUSION: Although MSA remains a viable surgical alternative, our study indicated that SGRY can produce better symptom control and decrease acid exposure compared with MSA in patients with post-SG GERD.

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INTRODUCTION: Management of gastroesophageal reflux disease after bariatric procedures can be challenging. There are very few long-term studies in this arena. This study aims to evaluate the long-term outcomes of the magnetic sphincter augmentation (MSA) reflux management system in a cohort of bariatric patients who had previously undergone sleeve gastrectomy and Roux-en-Y gastric bypass, with a focus on assessing gastroesophageal reflux disease (GERD) scores, medication use, and patient-reported symptoms. METHODS: We conducted a retrospective chart review of 16 consecutive bariatric patients who received MSA implants following sleeve gastrectomy (n = 14) or gastric bypass (n = 2) surgeries. Data were collected regarding BMI, GERD quality of life assessments (GERD-HRQL), reflux symptoms, and use of PPIs in the sleeve/RGB patients through an extended period with a mean follow-up of 48 months. RESULTS: Patients were followed up for a range of .5-84 months. Preoperative assessments included upper gastrointestinal imaging (UGI), high-resolution manometry, Bravo pH studies, and esophagogastroduodenoscopy (EGD). Three patients exhibited reflux on UGI, and 13/13 patients had positive Bravo studies preoperatively. Sixteen patients had a lower esophageal sphincter (LES) pressure under 18 mmHg, and eight patients had biopsy-proven esophagitis. Long-term outcomes are as follows. Daily PPI use fell from 88 to 25% at greater than three years. GERD-HRQL scores fell from 50.6 at baseline (range 27-70) and normalized at long-term follow-up. GERD symptom of regurgitation completely resolved. At long term, two patients had dysphagia and two patients had ongoing reflux. No adverse events were noted. CONCLUSION: This is the first long-term outcomes study of magnetic sphincter augmentation placement after bariatric surgery. Our study showed the majority of patients had long-term improvement in GERD-HRQL scores and resolution/ relief of their reflux symptoms, with decreased use of PPIs. MSA is a safe, effective and durable management tool for reflux after bariatric surgery in carefully selected patients.

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BACKGROUND: An increasing number of reflux patients opt for magnetic sphincter augmentation (MSA) instead of fundoplication. However, few studies compare the medium-term efficacy and safety of the procedures. METHODS: We conducted a retrospective single-center analysis of consecutive MSA and Nissen fundoplication cases between 01/2015 and 06/2020. Patients underwent surgery, including hiatoplasty, for medical treatment-resistant reflux due to hiatal hernia. Surgical revision and proton pump inhibitor (PPI) reuptake rates were the primary outcomes. We also compared adverse event rates. Patients with severe preoperative dysphagia/motility disorders were assigned different treatment pathways and excluded from the analysis. We used propensity-score matching to reduce confounding between treatments. RESULTS: Out of 411 eligible patients, 141 patients who underwent MSA and 141 with fundoplication had similar propensity scores and were analyzed. On average, patients were 55 ± 12 years old and overweight (BMI: 28 ± 5). At 3.9 years of mean follow-up, MSA was associated with lower surgical revision risk as compared to fundoplication (1.2% vs 3.0% per year, respectively; HR: 0.38; 95% CI 0.15-0.96; p = 0.04), and similar PPI-reuptake risk (2.6% vs 4.2% per year; HR: 0.59; 95% CI 0.30-1.16; p = 0.12). Adverse event rates during primary stay were similar (MSA vs. fundoplication: 1% vs. 3%, p = 0.68). Fewer patients experienced adverse events in the MSA group after discharge (24% vs. 33%, p = 0.11), driven by higher rates of self-limiting dysphagia (1% vs. 9%, p < 0.01) and gas/bloating (10% vs. 18%, p = 0.06) after fundoplication. Differences between MSA and fundoplication in dysphagia requiring diagnostic endoscopy (11% vs. 8%, p = 0.54) or surgical revision (2% vs. 1%, p = 1.0) were non-significant. The device explantation rate was 4% (5/141). CONCLUSION: MSA reduces the re-operation risk compared to fundoplication and may decrease adverse event rates after discharge. Randomized head-to-head studies between available surgical options are needed.

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Although most patients with reflux can be managed with medical therapy, some require surgical intervention to manage their disease. Newer technologies, such as magnetic sphincter augmentation (MSA), have been promoted as the replacement of fundoplication. However, as time has elapsed, our institution noticed the need for the removal of MSA devices. Although a few reports have described MSA device removals, we provide a deeper explanation of how to perform a robotic device removal. Our article describes the technical steps and includes a video to demonstrate how to complete the surgery robotically.

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BACKGROUND: One of the most prevalent conditions in Western societies is gastroesophageal reflux disease (GERD). In Switzerland, the standard treatment for GERD is proton pump inhibitor (PPI)-based medical management, but surgical options such as Nissen fundoplication and magnetic sphincter augmentation (MSA) are available. RefluxStop is a novel device that offers an alternative solution. The purpose of this report is to evaluate the cost-effectiveness of RefluxStop compared to PPIs and existing surgical treatments. METHODS: A model (Markov) was developed using the Swiss healthcare payer perspective with a lifetime horizon, 1-month cycle length, and a 3% annual discount rate for costs and benefits. Adverse events specific to treatment arms were incorporated, and benefits were measured in quality-adjusted life-years (QALYs). Clinical efficacy data for RefluxStop was obtained from its CE mark study, and comparator treatments were based on published literature. Deterministic and probabilistic sensitivity analyses were used to explore uncertainty. Since there are no head-to-head studies between RefluxStop and PPI therapy, Nissen fundoplication, or MSA, a limitation of this study is the use of naïve, indirect comparison of clinical effectiveness between the studied treatment options. RESULTS: Higher QALYs and lower costs were provided by RefluxStop compared to Nissen fundoplication and the MSA system. The incremental cost-effectiveness ratio (ICER) for RefluxStop was CHF 2,116 in comparison to PPI-based medical management. At a cost-effectiveness threshold of CHF 100,000 per QALY gained, the probability of RefluxStop being cost-effective was high, with probabilities of 100%, 97%, and 100% against PPI-based medical management, Nissen fundoplication, and MSA, respectively. The robustness of the analysis was provided by deterministic and probabilistic sensitivity analyses. CONCLUSION: This cost-effectiveness analysis demonstrates that there is a high likelihood of RefluxStop being a cost-effective treatment modality in adults with GERD when compared with other treatment options available in Switzerland.

Gastroesophageal reflux disease (GERD) is one of the most prevalent conditions in Western societies. Standard treatment in Switzerland entails proton pump inhibitor (PPI)-based medical management or surgical options (i.e., Nissen fundoplication and magnetic sphincter augmentation [MSA]) in selected cases. RefluxStop is a new technology indicated for the surgical treatment of GERD that restores the normal anatomy of the anti-reflux barrier. The clinical benefits and monetary costs of RefluxStop must be weighed against available treatment options to determine the role of this new technology in Switzerland. Cost-effectiveness analyses compare the relative costs and clinical outcomes of disease management when pursuing different paths in the patient journey landscape, as measured by quality-adjusted life-years (QALYs). In the present study, RefluxStop in comparison to Nissen fundoplication, and MSA, provided higher QALYs and lower costs. Against PPI therapy, the costs were slightly higher but the QALYs were also higher, generating a favourable Incremental cost-effectiveness ratio. Furthermore, at the cost-effectiveness threshold of CHF 100,000 per QALY gained, RefluxStop was highly likely to be cost-effective in comparison to PPI therapy, Nissen fundoplication, and MSA with probabilities of 100%, 97%, and 100%, respectively. Ultimately, this cost-effectiveness analysis showed that RefluxStop has a high likelihood of cost-effectiveness as a GERD treatment in Switzerland against other treatment options, with results being robust even with uncertainties considered in additional sensitivity analyses.

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BACKGROUND: Magnetic sphincter augmentation (MSA) explantation is an uncommon occurrence, and there are limited studies characterizing factors predictive of MSA explantation. This study aimed to create a nomogram to aid in determining the probability of explantation in patients before MSA implantation. METHODS: An institutional review board-approved, prospectively maintained database was retrospectively reviewed for all patients undergoing antireflux surgery between February 2015 and May 2023. All patients who underwent MSA-related procedures were included. Patients were divided into 2 groups, explant group and nonexplant group, and differences were analyzed. A multivariable logistic regression model was fitted to identify independent risk factors for predicting MSA explantation, and a nomogram-based scoring tool was developed. RESULTS: There were 227 patients (134 females and 93 males) with a mean age of 51.4 years. The explant group included 28 patients (12.3%), whereas the nonexplant group included 199 patients (87.7%). Patient sociodemographic characteristics, medical comorbidities, preoperative testing results, and surgical history were included in the analysis. The multivariable regression model resulted in 4 significant variables that were included in the nomogram. These included preoperative DeMeester score, preoperative gastroesophageal reflux disease health-related quality of life score, preoperative distal contractile integral value on manometry, and body mass index. Based on these variables, a scoring nomogram was developed with values ranging from 0 to 18. CONCLUSION: Our data were used to develop a scoring calculator capable of predicting the probability of MSA explantation. This scoring tool can guide preoperative patient selection and treatment decisions.

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INTRODUCTION: Magnetic sphincter augmentation (MSA) is an effective treatment for typical reflux symptoms, but data on its impact on laryngopharyngeal reflux (LPR) is limited. This study aimed to determine the efficacy of MSA for LPR and to identify predictors of outcome. METHODS: This was a retrospective review of 775 patients who underwent MSA between 2013 and 2021. LPR was defined as presence of atypical reflux symptoms and a reflux symptom index (RSI) score >13. Favorable outcome was defined as primary symptom resolution, freedom from proton pump inhibitors, and five-point improvement or RSI score normalization. Preoperative clinical, high-resolution manometry, and impedance-pH data were analyzed for impact on favorable outcome using univariate followed by multivariable analysis. RESULTS: There were 128 patients who underwent MSA for LPR. At a mean (SD) follow-up of 13 (5.4) months, favorable outcome was achieved by 80.4% of patients, with median (IQR) RSI score improving from 29 (22-35) to 9 (4-17), (P < 0.001). Independent predictors of favorable outcome on multivariable analysis included LPR with typical reflux symptoms [OR (95% CI): 8.9 (2.3-31.1), P = 0.001], >80% intact swallow on high-resolution manometry [OR (95% CI): 3.8 (1.0-13.3), P = 0.035], upper esophageal sphincter (UES) resting pressure >34 mmHg [OR (95% CI): 4.1 (1.1-14.1), P = 0.027] and short total proximal acid clearance time [OR (95% CI): 1.1 (1.0-1.1), P = 0.031]. Impedance parameters including number of LPR events, full column reflux and proximal acid exposure events were similar between outcome groups (P > 0.05). CONCLUSION: MSA is an effective surgery for patients with LPR. Patients with concomitant typical reflux symptoms, normal esophageal body motility, and competent UES benefit the most from surgery. Individual impedance-pH parameters were not associated with outcome.

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PURPOSE: Magnetic Sphincter Augmentation (MSA) is an FDA-approved anti-reflux procedure with comparable outcomes to fundoplication. However, most data regarding its use are limited to single or small multicenter studies which may limit the generalizability of its efficacy. The purpose of this study is to evaluate the outcomes of patients undergoing MSA vs fundoplication in a national database. MATERIALS AND METHODS: The 2017-2020 American College of Surgeons National Surgical Quality Improvement Program (ACS-NSQIP) Registry was utilized to evaluate patients undergoing MSA or fundoplication. Patients requiring Collis gastroplasty, paraesophageal hernia repair, and emergency cases, were excluded. Patient outcomes included overall complication rates, readmissions, reoperations, and mortality. RESULTS: A total of 7,882 patients underwent MSA (n = 597) or fundoplication (n = 7285). MSA patients were younger (51 vs 57, p < 0.001), and more often male (49.6 vs 34.3%, p < 0.001). While patients undergoing MSA experienced similar rates of reoperation (1.0 vs 2.0%, p = 0.095), they experienced fewer readmissions (2.2 vs 4.7%, p = 0.005), complications (0.6 vs 4.0%, p < 0.001), shorter mean (SD) hospital length of stay(days) (0.4 ± 4.3 vs 1.8 ± 4.6, p < 0.001) and operative time(min) (80.8 ± 36.1 vs 118.7 ± 63.7, p < 0.001). Mortality was similar between groups (0 vs 0.3%, p = 0.175). On multivariable analysis, MSA was independently associated with reduced postoperative complications (OR 0.23, CI 0.08 to 0.61, p = 0.002), readmissions (OR 0.53, CI 0.30 to 0.94, p = 0.02), operative time (RC - 36.56, CI - 41.62 to - 31.49. p < 0.001) and length of stay (RC - 1.22, CI - 1.61 to - 0.84 p < 0.001). CONCLUSION: In this national database study, compared to fundoplication MSA was associated with reduced postoperative complications, fewer readmissions, and shorter operative time and hospital length of stay. While randomized trials are lacking between MSA and fundoplication, both institutional and national database studies continue to support the use of MSA as a safe anti-reflux operation.

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Background: Gastro-oesophageal reflux disease (GORD) is a common condition associated with heartburn and regurgitation. Standard of care for GORD patients in the UK involves initial treatment with proton pump inhibitors (PPIs) and laparoscopic antireflux surgery in patients unwilling to continue or intolerant of long-term PPI treatment. Recently, RefluxStop™, a novel, implantable medical device, has proven to be an efficacious and cost-effective treatment for patients with GORD. The current analysis aimed to describe the budget impact of introducing RefluxStop™ within National Health Service (NHS) England and Wales. Objectives: To estimate the more immediate, short-term clinical and economic effects of introducing RefluxStop™ as a therapeutic option for patients with GORD treated within NHS England and Wales. Methods: A model adherent to international best practice guidelines was developed to estimate the budget impact of introducing RefluxStop™ over a 5-year time horizon, from an NHS perspective. Two hypothetical scenarios were considered, one without RefluxStop™ (comprising PPI treatment, laparoscopic Nissen fundoplication, and magnetic sphincter augmentation using the LINX® system) and one with RefluxStop™ (adding RefluxStop™ to the aforementioned treatment options). Clinical benefits and costs associated with each intervention were included in the analysis. Results: Over 5 years, introducing RefluxStop™ allowed the avoidance of 347 surgical failures, 39 reoperations, and 239 endoscopic esophageal dilations. The financial impact of introducing RefluxStop™ was £3 029 702 in year 5, corresponding to a 1.68% increase in annual NHS spending on GORD treatment in England and Wales. Discussion: While the time horizon was too short to capture some of the adverse events of PPIs and complications of GORD, such as the development of Barrett's esophagus or esophageal cancer, the use of RefluxStop™ was associated with a substantial reduction in surgical complications, including surgical failures, reoperations, and endoscopic esophageal dilations. This favorable clinical profile resulted in cost offsets for the NHS and contributed to the marginal budget impact of RefluxStop™ estimated in the current analysis. Conclusions: Introducing RefluxStop™ as a treatment option for patients with GORD in England and Wales may be associated with clinical benefits at the expense of a marginal budget impact on the NHS.

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Abdominal bloating (AB) is a common symptom among patients with gastroesophageal reflux disease (GERD); however, in clinical practice, its prevalence is likely underestimated due to the lack of objective tools to measure its frequency and severity. It is associated with dissatisfaction and worse quality of life, but data on its prevalence before and after mechanical control of GERD (i.e. fundoplication, magnetic sphincter augmentation, and antireflux mucosectomy) are lacking. To assess and determine the pre- and postoperative prevalence and severity of AB among patients with GERD, we conducted a structured literature search using MeSH and free-text terms in MEDLINE (via Pubmed), EMBASE, and Taylor & Francis Online between January 1977 and October 2022. Fifteen articles reporting the prevalence or severity of AB using quality-of-life questionnaires before or after antireflux surgery (ARS) were included. Overall, a high prevalence of AB before ARS was found. A decline in the prevalence and severity of AB was documented postoperatively in most cases independent of the surgical approach. Among surgical approaches, a complete fundoplication had the highest reported postoperative AB. Overall, patients reported less severe and less frequent AB after ARS than before. The traditional belief that postoperative bloating is a sequela of ARS should be reevaluated.

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Background: The magnetic sphincter augmentation (MSA) procedure is an effective treatment for gastroesophageal reflux disease (GERD). Adverse events requiring MSA device removal are rare, but the true prevalence and incidence may be underestimated. Methods: Retrospective study on a prospectively collected database. Patients who underwent MSA procedure between March 2007 and September 2021 in two tertiary-care referral centers for esophageal surgery were included. The trend of MSA explant, the changes in the sizing technique and crura repair over the years, the technique of explant, and the clinical outcomes of the revisional procedure were reviewed. Results: Out of 397 consecutive patients, 50 (12.4%) underwent MSA removal, with a median time to explant of 39.5 [IQR = 53.7] months. Main symptoms leading to removal were dysphagia (43.2%), heartburn (25%), and epigastric pain (13.6%). Erosion occurred in 2.5% of patients. Smaller (12- and 13-bead) devices were the ones most frequently explanted. The majority of the explants were performed laparoscopically with endoscopic assistance. There was no perioperative morbidity, and the median length of stay was 2.8 ± 1.4 days. After 2014, changes in sizing technique and crura repair resulted in a decreased incidence of explants from 23% to 5% (p < 0.0001). Multivariate analysis confirmed the protective role of added bead units [HR 0.06 (95% CI = 0.001-0.220); p < 0.000]. Conclusion: Oversizing and full mediastinal dissection with posterior hiatoplasty may improve the outcomes of the MSA procedure and possibly reduce removal rates.

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The surgical management of gastroesophageal reflux disease (GERD) has evolved significantly over the past century, driven by increased understanding of the physiology of the reflux barrier, its anatomic components, and surgical innovation. Initially, emphasis was on reduction of hiatal hernias and crural closure as the etiology behind GERD was felt to be solely related to the anatomic alterations caused by hiatal hernias. With persistence of reflux-related changes in some patients despite crural closure, along with the development of what is now modern manometry and the discovery of a high-pressure zone at the distal esophagus, focus evolved to surgical augmentation of the lower esophageal sphincter (LES). With this transition to an LES-centric approach, attention shifted to reconstruction of the angle of His, ensuring sufficient intra-abdominal esophageal length, development of the now commonly employed Nissen fundoplication, and creation of devices that directly augment the LES such as magnetic sphincter augmentation. More recently, the role of crural closure in antireflux and hiatal hernia surgery has again received renewed attention due to the persistence of postoperative complications including wrap herniation and high rates of recurrences. Rather than simply preventing transthoracic herniation of the fundoplication as was originally thought, diaphragmatic crural closure has been documented to have a key role in re-establishing intra-abdominal esophageal length and contributing to the restoration of normal LES pressures. This progression from a crural-centric to a LES-centric approach and back has evolved along with our understanding of the reflux barrier and will continue to do so as more advances are made in the field. In this review, we will discuss the evolution of surgical techniques over the past century, highlighting key historical contributions that have shaped our management of GERD today.

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Up to 30% of patients with gastroesophageal reflux disease (GERD) suffer from laryngopharyngeal reflux (LPR) with symptoms, as chronic cough, laryngitis, or asthma. Besides life-style modifications and medical acid suppression, laparoscopic fundoplication is an established treatment option. Treatment-related side effects after laparoscopic fundoplication have to be weighted against LPR symptom control in 30-85% of patients after surgery. Magnetic sphincter augmentation (MSA) is described as an effective alternative to fundoplication for surgical treatment of GERD. However, evidence on the efficacy of MSA in patients with LPR is very limited. Preliminary data on the results of MSA treating LPR symptoms in patients with acid and weakly acid reflux are promising; showing comparable results to laparoscopic fundoplication by providing the potential of decrease side effects.

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Magnetic sphincter augmentation (MSA) is an anti-reflux procedure with comparable outcomes to fundoplication, yet its use in patients with larger hiatal or paraesophageal hernias has not been widely reported. This review discusses the history of MSA and how its utilization has evolved from initial Food and Drug Administration (FDA) approval in 2012 for patients with small hernias to its contemporary use in patients with paraesophageal hernias and beyond.

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BACKGROUND: The most recent update of the Chicago Classification (CCv4.0) attempts to provide a more clinically relevant definition for ineffective esophageal motility (IEM). The impact of this new definition on predicting outcome after antireflux surgery is unknown. The aim of this study was to compare utility of IEM diagnosis based on CCv4.0 to CCv3.0 in predicting surgical outcome after magnetic sphincter augmentation (MSA) and to assess any additional parameters that hold value in future definitions. METHODS: Records of 336 patients who underwent MSA at our institution between 2013 and 2020 were reviewed. Preoperative manometry files were re-analyzed using both Chicago Classification version 3.0 (CCv3.0) and CCv4.0 definitions of IEM. The utility of each IEM definition in predicting surgical outcome was then compared. Individual manometric components and impedance data were also assessed. KEY RESULTS: Immediate dysphagia was reported by 186 (55.4%) and persistent dysphagia by 42 (12.5%) patients. CCv3.0 IEM criteria were met by 37 (11%) and CCv4.0 IEM by 18 (5.4%) patients (p = 0.011). CCv3.0 and CCv4.0 IEM were equally poor predictors of immediate (AUC = 0.503 vs. 0.512, p = 0.7482) and persistent (AUC = 0.519 vs. 0.510, p = 0.7544) dysphagia. The predicted dysphagia probability of less than 70% bolus clearance (BC) was 17.4%, higher than CCv4.0 IEM at 16.7%. When BC was incorporated into CCv4.0 IEM criteria, the probability increased significantly to 30.0% (p = 0.0042). CONCLUSIONS & INFERENCES: The CCv3.0 and CCv4.0 of IEM are poor predictors of dysphagia after MSA. Adding BC to the new definition improves its predictive utility and should be considered in future definitions.

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INTRODUCTION: The impact of delayed gastric emptying (DGE) on the outcome of anti-reflux surgery (ARS) is controversial. There is concern that poor gastric emptying diminishes outcomes. Magnetic sphincter augmentation (MSA) may have a comparatively mild impact on gastric physiology, but the relationship between DGE and MSA outcomes is unknown. This study aims to evaluate the relationship between objective DGE and MSA outcomes over time. METHODS: Patients who completed gastric emptying scintigraphy (GES) prior to MSA between 2013 and 2021 were included. DGE was defined as a 4 h retention > 10% or half emptying time > 90 min on GES. Outcomes were compared between DGE and normal gastric emptying (NGE) groups at 6 months, 1 and 2 years. Sub-analysis of patients with severe (> 35%) DGE and correlation analysis between 4-h retention and symptom and acid-normalization were performed. RESULTS: The study population consisted of 26 (19.8%) patients with DGE and 105 with NGE. DGE was associated with more 90-days readmissions (18.5 vs 2.9%, p = 0.009). At 6 months patients with DGE had higher median (IQR) GERD-HRQL total [17.0(10-29) vs 5.5(3-16), p = 0.0013], heartburn [1(1-3) vs 0(0-1), p = 0.0010) and gas-bloat [4(2-5) vs 2(1-3), p = 0.033] scores. Outcomes at 1 and 2 years follow-up were comparable (p > 0.05). From 6 months to 1-year the gas-bloat score decreased from 4(2-5) to 3(1-3), p = 0.041. Total and heartburn scores decreased, but not significantly. Severe DGE (n = 4) patients had lower antiacid medication freedom at 6 months (75 vs 87%, p = 0.014) and 1-year (50 vs 92%, p = 0.046). There were non-significant trends for higher GERD-HRQL scores, dissatisfaction, and removal rates in severe DGE at 6 months and 1-year. There was a weak correlation between 4-h retention and 6-month GERD-HRQL total score [R = 0.253, 95%CI (0.09-0.41), p = 0.039], but not acid-normalization (p > 0.05). CONCLUSION: Outcomes after MSA are diminished early on in patients with mild-to-moderate DGE, but comparable by 1 year and durable at 2 years. Severe DGE outcomes may be suboptimal.

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BACKGROUND: Dysphagia is the most common complaint after magnetic sphincter augmentation (MSA), with nearly one-third of patients requiring at least one dilation following MSA. A subset of patients require frequent dilations, but there is a paucity of data on the characteristics of this population. This study aimed to identify predictors of the need for frequent dilations within the first year after implant and to assess these patients' outcomes. METHODS: This is a retrospective review of prospectively collected data of patients who underwent MSA over an 8-year period. Frequent dilations were defined as 2 or more dilations within 1 year of surgery. Patients completed baseline and 1-year postoperative GERD-HRQL questionnaires and objective physiology testing. Baseline demographic, clinical characteristics, and objective testing data were compared between patients who did and did not require frequent dilations. RESULTS: A total of 697 (62.7% female) patients underwent MSA, with 62 (8.9%) patients requiring frequent dilation. At a mean (SD) of 12.3 (3.4) months follow-up, the frequent dilation group had higher median GERD-HRQL total scores (21.0 vs. 5.0, p < 0.001), PPI use (20.8% vs.10.1%, p = 0.023), dissatisfaction (46.7% vs. 11.6%, p < 0.001), and device removal (25.8% vs. 2.2%, p < 0.001) rates. Acid normalization was comparable (p = 0.997). Independent predictors of frequent dilation included preoperative odynophagia (OR 2.85; p = 0.001), IRP > 15 mmHg (OR 2.88; p = 0.006), and > 30% incomplete bolus clearance (OR 1.94; p = 0.004). At a mean (SD) of 15.7 (10.7) months, 28 (45.1%) patients underwent device removal after frequent dilation. Independent predictors of device removal after frequent dilation within 5 years of surgery were preoperative odynophagia (OR 7.18; p = 0.042), LES resting pressure > 45 mmHg (OR 28.5; p = 0.005), and ≥ 10% failed swallows (OR 23.5; p < 0.001). CONCLUSIONS: The need for frequent dilations after MSA is a marker for poor symptom control, dissatisfaction, and device removal. Patients with preoperative odynophagia, high LES pressures, and poor esophageal motility should be counseled of their risk for these poor outcomes.

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