Magnetic Sphincter Augmentation Research Articles

Laparoscopic Magnetic Sphincter Augmentation for Symptomatic Gastroesophageal Reflux After Roux-en-Y Gastric Bypass: Outcome in 13 Patients

Abstract Background Gastroesophageal reflux disease (GERD) represents a common burden after bariatric procedures, particularly after laparoscopic sleeve gastrectomy (LSG). While GERD after LSG is usually treated with conversion to Roux-en-Y gastric bypass (RYGB), there are limited surgical options to manage medically refractory GERD after RYGB due to the altered anatomy. The use of magnetic sphincter augmentation (MSA) is one option, but the literature on this topic remains scarce. Aims To present mid- to long-term outcome of patients treated with MSA for GERD after RYGB. Methods We performed a retrospective single-centre analysis of data from patients who underwent laparoscopic MSA for GERD between August 2015 and December 2023, and who had previously RYGB. Outcomes were persistence/recurrence of GERD symptoms, use of proton pump inhibitors (PPIs) and need for redo surgery related to MSA complications or recurrent GERD. Results Of the 312 MSA procedures performed for GERD, we identified 13 patients who underwent laparoscopic MSA after RYGB. There were 10 female patients (77%), with mean age of 42.6 ± 13.7 years and mean BMI of 27.2 ± 2.7 kg/m2. Seven patients (54%) had de novo GERD. All MSA procedures included hiatoplasty. Median follow-up was 40 months (range 7-72) and median time between RYGB and MSA placement was 42 months (range 8-242). One patient (8%) required endoscopic dilatation due to persistent postoperative dysphagia. Two patients (15%) needed redo surgery: 1 redo hiatoplasty with adhaesiolysis and 1 conversion to esophagojejunostomy with implant removal. There was no erosion or migration of the MSA implant. Overall satisfactory control of reflux with discontinuation or reduction of PPIs was achieved in 9 patients (69%). Conclusion The use of MSA to manage refractory GERD after RYGB is a safe option and was effective in 69% of patients but is limited to patients with intact oesophageal motility.

Magnetic sphincter augmentation in the management of gastro-esophageal reflux disease: A systematic review and meta-analysis.

Magnetic sphincter augmentation (MSA) through placement of the LINX device is an alternative to fundoplication in the management of gastro-esophageal reflux disease (GERD). This systematic review and meta-analysis aimed to assess efficacy, quality of life and safety in patients that underwent MSA, with a comparison to fundoplication. A literature search of MEDLINE, Embase, Emcare, Scopus, Web of Science and Cochrane library databases was performed for studies that reported data on outcomes of MSA, with or without a comparison group undergoing fundoplication, for GERD from January 2000 to January 2023. Meta-analysis was performed using random-effect models and between-study heterogeneity was assessed. Thirty-nine studies with 8,075 patients were included: 6,983 patients underwent MSA and 1,092 patients had laparoscopic fundoplication procedure. Ten of these studies (seven retrospective and three prospective) directly compared MSA with fundoplication. A higher proportion of individuals successfully discontinued proton-pump inhibitors (P<0.001; WMD 0.83; 95% CI 0.72-0.93; I2=96.8%) and had higher patient satisfaction (P<0.001; WMD 0.85; 95% CI 0.78-0.93; I2=85.2%) following MSA when compared to fundoplication. Functional outcomes were better after MSA than after fundoplication including ability to belch (P<0.001; WMD 0.96; 95% CI 0.93-0.98; I2=67.8) and emesis (P<0.001; WMD 0.92; 95% CI 0.89-0.95; I2=42.8%), and bloating (P=0.003; WMD 0.20; 95% CI 0.07-0.33; I2=97.0%). MSA had higher rates of dysphagia (P=0.001; WMD 0.41; 95% CI 0.17-0.65; I2=97.3%) when compared to fundoplication. The overall erosion and removal rate following MSA was 0.24% and 3.9% respectively, with no difference in surgical re-intervention rates between MSA and fundoplication (P=0.446; WMD 0.001; 95% CI -0.001-0.002; I2 =78.5%). MSA is a safe and effective procedure at reducing symptom burden of GERD and can potentially improve patient satisfaction and functional outcomes. However, randomized controlled trials directly comparing MSA with fundoplication are necessary to determine where MSA precisely fits in the management pathway of GERD.

Predictability of Magnetic Sphincter Augmentation Device Explantation: A Nomogram-based Scoring Tool from an Experienced Quaternary Center

BackgroundMagnetic sphincter augmentation (MSA) explantation is an uncommon occurrence, and there are limited studies characterizing factors predictive for explanation. The aim of this study was to create a nomogram to aid in determining the probability of explantation in patients before undergoing MSA implantation. MethodsAn institutional review board-approved, prospectively maintained database was retrospectively reviewed for all patients undergoing anti-reflux surgery between February 2015 and May 2023. All patients who underwent MSA-related procedures were included. Patients were divided into two groups, explant group and non-explant 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. ResultsThere were 227 patients (134 females; 93 males) with a mean age of 51.4 years. The explant group included 28 patients (12.3%), whereas the non-explant group included 199 patients (87.7%). Patient sociodemographic characteristics, medical comorbidities, preoperative testing results, and surgical history were included in our 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 (GERD-HRQL) score, preoperative distal contractile integral (DCI) value on manometry, and body mass index (BMI). Based on these variables, a scoring nomogram was developed with values from 0 to 18. ConclusionOur data was 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.

Medium term (> 12 months) outcomes after laparoscopic hiatal hernia repair without conventional fundoplication using PH4B-mesh implant (Phasix™) in 176 reflux patients: experience and technique.

Hiatal mesh repair remains a controversial topic among anti-reflux surgeons. Biosynthetic mesh cruroplasty may prevent early recurrence while avoiding late esophageal erosion and strictures associated with non-resorbable materials. So far, medium-term results on hiatal PH4B (Poly-4-Hydroxybutyrate) mesh repair from high-volume centers are lacking. We analyzed the medium-term efficacy and safety of PH4B mesh cruroplasty in 176 consecutive patients (≥ 18years) with symptomatic hiatal hernias. Treatment failure was defined as the clinical recurrence of reflux symptoms. Patients could choose between mesh augmented hiatal repair (combined with a modified anterior hemifundoplication and fundophrenicopexy), Nissen fundoplication, and magnetic sphincter augmentation at their discretion. We also describe the surgical approach to mesh augmented hiatal repair used at our center. On average, patients were 55 (± 14) years old and followed up for 22 (± 7; sum: 3931) months. Treatment failed in 6/176 (3%, 95% CI: 2-7%) patients. The 24-month Kaplan-Meier failure estimate was 2.8% (95% CI: 0.4-5%). Each centimeter in hernia size increased the risk of failure by 52% (p = 0.02). Heavier patients (BMI > 27) had an 11% higher probability of clinical symptom recurrence (p = 0.03). The dysphagia and bloating/gas rate were 13/176 (7%), each. 8 (5%) patients required endoscopy due to dysphagia but without intervention. No serious complications, including mesh infection and erosion, or fatalities, occurred. Augmented PH4B mesh cruroplasty without conventional fundoplication shows excellent intermediate-term results in patients with reflux disease due to hiatal hernia. Around one in thirty patients experience treatment failure within 2years of surgery. Hernia size and overweight are key determinants of treatment failure.

Is magnetic anal sphincter augmentation still an option in fecal incontinence treatment: a systematic review and meta-analysis.

Magnetic anal sphincter (MAS) augmentation is a novel surgical option for the treatment of fecal incontinence. Current clinical evidence is conflicting. The purpose of this meta-analysis was to report the safety profile, potential benefits, and the functional efficacy of this device. The study followed the PRISMA guidelines. Literature databases (Medline, Scopus, Web of Science, CENTRAL) were screened for eligible articles. The primary endpoint was the pooled effect of MAS in the Cleveland Clinic Incontinence Score (CCIS) score. Quality evaluation was based on the ROBINS-I and Risk of Bias 2 tool. Overall, 8 studies with 205 patients were included. MAS resulted in a significant reduction of CCIS values (p = 0.019), and improvement only in the embarrassment domain of FIQoL scores (p = 0.034). The overall morbidity rate was 61.8%. Postoperative adverse events included MAS explantation in 12%, infection in 5.1%, pain in 10% and obstructed defecation in 5.8% of patients. The application of MAS in patients with fecal incontinence results in the improvement of some clinical parameters with a notable morbidity rate. Due to several study limitations, further, high-quality RCTs are required to delineate the efficacy and safety of MAS.

Impact of Change in Sizing Protocol on Outcome of Magnetic Sphincter Augmentation.

To evaluate and compare magnetic sphincter augmentation (MSA) device sizing protocols on postoperative outcomes and dysphagia. Among predictors of dysphagia after MSA, device size is the only factor that may be modified. Many centers have adopted protocols to increase device size. However, there is limited data on the impact of MSA device upsizing protocols on the surgical outcomes. Patients who underwent MSA were implanted with 2 or 3-beads above the sizing device's pop-off point (POP). Clinical and objective outcomes >1-year after surgery were compared between patients implanted with POP+2-vs-POP+3 sizing protocols. Multiple subgroups were analyzed for benefit from upsizing. Pre- and postoperative characteristics were compared between size patients received, regardless of protocol. A total of 388 patients were implanted under POP+2 and 216 under POP+3. At a mean of 14.2(7.9) months pH normalization was 73.6% and 34.1% required dilation, 15.9% developed persistent dysphagia, and 4.0% required removal. Sizing protocol had no impact on persistent dysphagia ( P =0.908), pH normalization ( P =0.822), or need for dilation ( P =0.210) or removal ( P =0.191). Subgroup analysis found that upsizing reduced dysphagia in patients with <80 percent peristalsis (10.3-vs-31%, P =0.048) or DCI >5000 (0-vs-30.4%, P =0.034). Regardless of sizing protocol, as device size increased there was a stepwise increase in percent male sex ( P <0.0001), BMI>30 ( P <0.0001), and preoperative hiatal hernia>3cm ( P <0.0001), LA grade C/D esophagitis ( P <0.0001), and DeMeester score ( P <0.0001). Increased size was associated with decreased pH-normalization ( P <0.0001) and need for dilation ( P =0.043) or removal ( P =0.014). Upsizing from POP+2 to POP+3 does not reduce dysphagia or affect other MSA outcomes; however, patients with poor peristalsis or hypercontractile esophagus do benefit. Regardless of sizing protocol, preoperative clinical characteristics varied among device sizes, suggesting size is not a modifiable factor, but a surrogate for esophageal circumference.

Short term safety of magnetic sphincter augmentation vs minimally invasive fundoplication: an ACS-NSQIP analysis

PurposeMagnetic 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 MethodsThe 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.ResultsA 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).ConclusionIn 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.

Budget Impact of RefluxStop™ as a Treatment for Patients with Refractory Gastro-oesophageal Reflux Disease in the United Kingdom.

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.

Budget Impact of RefluxStopTM as a Treatment for Patients with Refractory Gastro-oesophageal Reflux Disease in the United Kingdom

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.

Esophageal magnetic sphincter augmentation following bariatric surgery improves quality of life and reduces proton pump inhibitor usage

Esophageal magnetic sphincter augmentation following bariatric surgery improves quality of life and reduces proton pump inhibitor usage

Gas-Bloat Syndrome after Magnetic Sphincter Augmentation: Incidence, Natural History, Risk Factors, and Impact on Surgical Outcomes Over Time.

The notion that gas-bloat syndrome (GBS) after magnetic sphincter augmentation (MSA) is less detrimental has not been substantiated by data. This study aimed to identify the incidence, natural history, risk factors, and impact on outcomes of GBS after MSA. Records of patients who underwent MSA at our institution were reviewed. GBS was defined as a score of 4 or more on the gas bloat-specific item within the GERD health-related quality-of-life (GERD-HRQL) questionnaire. Preoperative clinical and objective testing data were compared between those with and without GBS at 1 year using univariate followed by multivariable analysis. GBS evolution over time and its impact on outcomes were assessed in those with 1- and 2-year follow-up. A total of 489 patients underwent MSA. At a mean (SD) follow-up of 12.8 (2.1) months, patient satisfaction was 88.8%, 91.2% discontinued antisecretory medications, and 74.2% achieved DeMeester score normalization.At 1 year, 13.3% of patients developed GBS, and had worse GERD-HRQL scores and antisecretory medication use and satisfaction (p < 0.0001). DeMeester score normalization was comparable (p = 0.856). Independent predictors of GBS were bloating (odds ratio [OR] 1.8, p = 0.043), GERD-HRQL score greater than 30 (OR 3, p = 0.0010), and MSA size 14 or less beads (OR 2.5, p = 0.004). In a subgroup of 239 patients with 2-year follow-up, 70.4% of patients with GBS at 1 year had resolution by 2 years. The GERD-HRQL total score improved when GBS resolved from 11 (7 to 19) to 7 (4 to 10), p = 0.016. Patients with persistent GBS at 2 years had worse 2-year GERD-HRQL total scores (20 [5 to 31] vs 5 [3 to 12], p = 0.019). GBS affects 13.3% of patients at 1 year after MSA and substantially diminishes outcomes. However, GBS resolves spontaneously with quality-of-life improvement. Patients with preoperative bloating, high GERD-HRQL scores, or small MSA devices are at greatest risk of this complication.

Comparative Outcomes of Magnetic Sphincter Augmentation and Fundoplication in Revisional Surgery

Background: Outcomes of laparoscopic revisional surgery involving Magnetic Sphincter Augmentation (MSA) have not been clearly delineated, whether MSA was the presenting or the revisional surgery. We compared safety and clinical outcomes of 4 main categories: fundoplication revised to fundoplication (F-F); fundoplication to MSA (F-M), MSA to fundoplication (M-F) and MSA to MSA (M-M). Methods: Analysis of prospective data from 10 U.S. sites participating in the Registry of Outcomes of Anti-Reflux Surgery (ROARS). Patients had undergone at least one prior procedure on the esophagogastric junction with subsequent need for revisional surgery. Results: Between 2/1/2005 and 1/19/23, 742 patients underwent 819 revisional surgeries, of which 645 patients had 722 surgeries in the 4 main categories. Seventy-six percent had their prior operation elsewhere. Indications for reoperation (GERD, hiatal hernia, dysphagia, gas-bloat) were similar across categories. Preoperative and intraoperative findings disclosed disruption of prior hernia repair in 80% and 97% of patients respectively. Hernia size was larger with an antecedent fundoplication (13% &gt;5 cm, 37% 3-5 cm) compared to patients with prior MSA (1.5% &gt;5 cm, 18% 3-5 cm ( P &lt; .0001). Revision of fundoplication resulted in 11% intraoperative complication rate, versus 2% for MSA. Six hundred patients (73.2%) were followed a mean of 2.7 years. Subsequent operation was performed on 77 (12.7%) a mean of 2.5 years; no difference between categories. Kaplan-Meier analysis showed equivalent subsequent reoperation rates at 5 years (20% ± 5%). Similar improvements in GERD-HRQL, bloating, dysphagia scores, ability to belch or vomit were seen. Conclusions: Over 95% of patients had disruption of the hiatus requiring repair, though prior MSA was associated with far fewer &gt;3 cm hernias than prior fundoplication. Patients with an antecedent MSA can be revised with similar safety and outcomes as those having an antecedent fundoplication. MSA has equivalent results to fundoplication when used as a revisional procedure post antecedent fundoplication.

OGBN P15 The cost-effectiveness of a novel implantable device for treating gastro-oesophageal reflux disease in the United Kingdom

Abstract Background Gastro-oesophageal reflux disease (GORD) is a common gastrointestinal condition characterized by heartburn, chest pain, and regurgitation. Chronic treatment with proton pump inhibitor (PPI)-based medical management is the current standard of care, with antireflux surgery considered in selected patients. RefluxStop is a novel implantable device indicated for patients eligible for laparoscopic anti-reflux surgery. The purpose of this analysis was to assess the cost-effectiveness of RefluxStop against other GORD treatment options in the UK. Methods A Markov model was developed to assess the cost-effectiveness of RefluxStop compared with PPI-based medical management, laparoscopic Nissen fundoplication, and magnetic sphincter augmentation (MSA) for management of GORD. The UK National Health Service perspective was adopted, with clinical outcomes and costs estimated over a lifetime horizon and an annual discount rate of 3.5% applied. Clinical efficacy data for RefluxStop was obtained from its CE mark study, and comparator treatments were based on published literature. Results RefluxStop demonstrated favorable surgical outcomes compared to both laparoscopic Nissen fundoplication and MSA. The base case incremental cost-effectiveness ratios (ICERs) compared with PPIs, laparoscopic Nissen fundoplication, and MSA were £4,156, £6,517, and £249 per quality-adjusted life-year (QALY) gained, respectively. With a UK cost-effectiveness threshold of £20,000 per QALY gained, the probabilities that RefluxStop was cost-effective compared with PPIs, laparoscopic Nissen fundoplication, and MSA were 100%, 93%, and 100%, respectively. Conclusions Based on this analysis, RefluxStop was estimated to improve quality of life and extend life expectancy in GORD patients when compared to PPIs, laparoscopic Nissen fundoplication, and MSA. Furthermore, this analysis demonstrated that RefluxStop is highly likely to be a cost-effective option for treating GORD in the UK.

OGBN O06 Enhancing Surgical Decision-Making with High-Resolution Manometry and Distal Contractile Integral in Preoperative Assessment for Magnetic Sphincter Augmentation (LINX)

Abstract Background Preoperative assessment for magnetic sphincter augmentation (MSA) (LINX) involves evaluating the Mean Distal Amplitude (MDA) on conventional manometry to assess the patient suitability and risk of post-operative dysphagia. In the last decade high-resolution manometry (HRM) has superseded conventional manometry owing to obtaining more clinical information on the oesophageal motility, including the Distal Contractile Integral (DCI) that incorporates contractile amplitude, duration and contractility propagation length within the oesophageal body. The purpose of this study is to translate the MDA to modern DCI as preoperative marker to MSA. Methods This retrospective study includes patients referred to oesophageal laboratory at Guy’s Hospital between March and May 2023. Patients underwent HRM with ten 5ml water swallows that provided manometric information to compute mean DCI and MDA (MDA waveforms at 11cm, 7cm and 3cm above the GOJ were used). Statistical analysis investigated the relationship between MDA and mean DCI using Pearson correlation, Student t-test, ROC curve analysis and relevant metrics assess the cut-off threshold accuracy and reliability in classifying normal MDA. Results 270 patients were included in the study (female:male=190:80 males, mean age 52.1 years). There was strong direct correlation between MDA and mean DCI (r=0.71, p&amp;lt;0.0001) (Figure 1). Patients with normal MDA had a significantly higher mean DCI compared with weak MDA at 11cm (601mmHgscm vs 167.15mmHgscm, p&amp;lt;0.0001) 7cm (286.4mmHgscm vs 741mmHgscm, p&amp;lt;0.001), 3cm (592mmHgscm vs 192.6mmHgscm, p&amp;lt;0.0001) and overall MDA (714.2mmHgscm vs 259mmHgscm, p&amp;lt;0.001) (Figure 2). ROC curve analysis revealed the mean DCI thresholds for normal MDA to be 615mmHgscm at 11cm, 419mmHgscm at 7cm, 318mmHgscm at 3cm and 453mmHgscm for the overall MDA (Table 1). Conclusions The findings of this study show HRM and the clinical measurement DCI may be a suitable preoperative assessment for MSA. This translation of MDA to modernisation in manometry may assist surgeons adopt DCI which is regarded as more robust assessment that offers more detailed clinical information of the oesophageal motility health and disorder.

OGBN P39 Feasibility and Safety of Laparoscopic Anti-Reflux Surgery at a District General Hospital: Matching National Standards and Improving Patient Quality of Life

Abstract Background Gastro-oesophageal Reflux Disease (GORD) affects a substantial proportion of adults in the UK, with surgery offering superior short-to-medium term benefits compared to medical management alone. However, there is significant variation in surgical practice nationwide. This study aimed to assess the feasibility and safety of laparoscopic anti-reflux surgery (LARS) at a District General Hospital (DGH) by aligning outcomes with the national standards set by AUGIS (Association of Upper Gastrointestinal Surgeons). Methods Prospective data from patients who underwent LARS between May 2022 and May 2023 were collected and recorded locally as well as on the National Hiatal Surgery Register (NHSR). Pre-operative symptoms and investigations, intraoperative findings, post-operative short and medium-term outcomes, and patient-reported outcome measures (PROMs) were analyzed. Quality of life (QoL) questionnaires, administered by the NHSR, were collected at 6 months to 1 year post-surgery. AUGIS standards, including a minimum of 5 procedures per year by 2 surgeons, conversion rate below 5%, 30-day return to theatre below 5%, and 30-day readmission rate below 10%, were utilized for comparison. Results In one year, two surgeons performed 41 LARS procedures: 31 Nissen, 4 Toupet, and 2 Dor wraps, with 2 redo surgeries. Minor complications occurred in 3 patients, requiring no intervention. One surgery was converted to open due to bleeding, and hiatal repair performed. Wrap migration led to re-do after 10 months. The 30-day return to theatre rate was 0%, readmission rate 2% (n=1, unremarkable CT scan). One patient discharged as a day case, average stay 4 days. Out of 23 eligible patients, 15 completed post-op questionnaires, showing significant QoL improvement. Additionally, 55% no longer needed anti-reflux meds at 6-month follow-up. Conclusions We significantly increased the number of LARS procedures performed while meeting the national standards set by AUGIS and we observed a significant improvement in our patients' quality of life following surgery. Experienced laparoscopic Upper GI surgeons can safely and effectively offer anti-reflux surgery in a DGH setting. Our commitment to prospective data collection for audit and research purposes has been a major strength. Future objectives include further consolidation of our work and expanding the range of procedures, such as magnetic sphincter augmentation (LINX), to improve day-case rates.

OGBN P36 Surgical Consideration in Patients with Ineffective Oesophagus: Implications for Low Risk of Dysphagia and Suitability for Antireflux Operation

Abstract Background Ineffective oesophageal motility (IOM) is a minor motility disorder that is commonly found in patients. The IOM diagnosis is based on heterogenous combination of failed peristalsis, weak peristalsis activity and peristaltic defects that are observed during the stimulation to 5mL standard water swallows. IOM is implicated to post-surgical dysphagia and therefore influences the surgical decision making. This paper will address this topic. Methods A retrospective review was conducted on patients who underwent oesophageal high-resolution manometry (HRM) between March and May 2023. The diagnosis of IOM was based on the international Chicago Classification guideline (version 4.0). Patients' oesophageal motility profiles were assessed for peristaltic reservation (PR) and oesophageal contractile mean wave amplitude (MWA). PR &amp;gt;100% in IOM patients indicates low risk of dysphagia after laparoscopic Nissen fundoplication (LNF). Similarly, normal MWA indicate a low risk of dysphagia in considering patients for Magnetic Sphincter Augmentation (MSA). Results 120/270 patients (44.4%) were diagnosed with IOM (female:male=86:34, median age 52 years old). Mean PR in IOM patients was 217.8% [95%CI:181.2%-254.4%] with 60.8% demonstrating PR &amp;gt;100%. Average MWA found in IOM patients was 40.8mmHg (95%CI:38.5mmHg-43.1mmHg) with 38.3% demonstrating normal MWA. 13.3% (16/120) of patients did not invoke peristalsis on MWS, but 6 of the 16 patients showed normal MWA. 24.2% (29/120) patients demonstrated PR &amp;gt;100% and normal MWA. 14.2% (17/120) of patients showed adequate PR and weak MWA and pose risk of postsurgical dysphagia. 75% (90/120) of patients with IOM were suitable for at least one antireflux operation. Conclusions Approximately half of the oesophageal physiology patients have IOM and three-quarters of these patients are suitable for at least one form surgical intervention with low risk postsurgical dysphagia. Only 14.2% of patients with IOM pose a risk of post-surgical dysphagia. The overall findings suggests that surgical intervention may be a viable option for patients with IOM that could potentially improve their quality of life and prevent reflux oesophagitis/pre-cancerous Barrett’s oesophagus. This study was limited by not investigating the relationship between IOM pathophysiology and the reflux oesophagitis severity grade.

OGBN P33 The Missing LINX® - Reconstituting the Hill Valve

Abstract Background Magnetic sphincter augmentation (MSA) with LINX® is an increasingly utilised procedure as an effective and safe alternative for fundoplication in the management of gastro oesophageal reflux disease (GORD). Our aim was to evaluate the post-operative LINX® endoscopic appearances in maintaining the competence of the Hills valve. Here we present a retrospective review of endoscopic assessment post insertion of LINX® Reflux Management System. Methods Patients who underwent magnetic sphincter augmentation with LINX® between December 2012 and December 2022 at a single district general hospital were recruited for a retrospective case analysis. Photographs taken at the time of endoscopy were assessed to evaluate the gastroesophageal flap valve using the Hill classification. Results Of 186 patients who underwent MSA, 40 underwent endoscopy post-operatively and of these 35 had photographs suitable for evaluation. There were various indications for endoscopy including dysphagia (13), dyspepsia (9), abdominal pain (7), laryngopharyngeal reflux (2), odynophagia (2), Barrett’s surveillance (1) and food bolus (1). Median time from LINX® to endoscopy was 2.5 years. 33 out of 35 patients (94.2%) were found to have Hills Grade I. One patient (2.8%) had Hills Grade II and one patient (2.8%) had a recurrence of their hiatus hernia, Hills Grade IV. Conclusions Endoscopy is a useful modality to assess symptomatic patients after MSA with LINX®. This study has confirmed reconstitution of the Hills valve on endoscopic assessment in 94.2% of patients. This supports LINX® as an effective and robust solution in the management of GORD.

Safety profile of magnetic sphincter augmentation for gastroesophageal reflux disease.

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. 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. 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]. Oversizing and full mediastinal dissection with posterior hiatoplasty may improve the outcomes of the MSA procedure and possibly reduce removal rates.

Staple Line Bacterial Load May Not Be a Contra-Indication to Magnetic Sphincter Augmentation Placement During Primary Sleeve Gastrectomy.

Staple Line Bacterial Load May Not Be a Contra-Indication to Magnetic Sphincter Augmentation Placement During Primary Sleeve Gastrectomy.

S1245 Patient Outcomes Following Transoral Incisionless Fundoplication and Magnetic Sphincter Augmentation with Concomitant Hiatal Hernia Repair

S1245 Patient Outcomes Following Transoral Incisionless Fundoplication and Magnetic Sphincter Augmentation with Concomitant Hiatal Hernia Repair