Laparoscopic 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.

Patient-reported outcomes of laparoscopic magnetic sphincter augmentation for gastro-oesophageal reflux disease.

Gastro-oesophageal reflux disease (GORD) is a chronic progressive disease, associated with substantial clinical and economic burden. Proton pump inhibitors (PPIs) are considered first-line treatment; however, there are concerns around the long-term impact of their usage. Surgical treatment with Nissen fundoplication can be considered but, because of the potential side effects, few patients undergo surgery and there remains a substantial therapeutic gap within the current treatment pathway. Laparoscopic magnetic sphincter augmentation (MSA) using the LINX® device is an alternative surgical approach. The objective of this study was to investigate patient-reported outcomes following laparoscopic MSA surgery using the LINX® device in a UK setting. A retrospective questionnaire obtained data regarding postoperative symptoms, medication use and patient satisfaction. Out of 131 patients surveyed, 97 responses were received, with a minimum follow-up time of 1 year. In those who reported heartburn and regurgitation preoperatively, improvement was reported in 93% (84/90) and 90% (86/96) of patients, respectively. Eighty-eight per cent (73/83) of patients were able to completely stop or reduce their medication by at least 75%. Seventy-seven per cent (73/95) of patients were "very satisfied" or "satisfied". This study is the first to present patient-reported outcomes of MSA using the LINX® device for patients with GORD in the UK. It demonstrates that the device has favourable outcomes and could effectively bridge the current therapeutic gap that exists between PPI medication and Nissen fundoplication.

Longer-term outcomes of gastroesophageal reflux disease treated with magnetic sphincter augmentation.

Surgical intervention for gastroesophageal reflux disease (GERD) has historically been limited to fundoplication. Magnetic sphincter augmentation (MSA) is a less invasive alternative that was introduced 15years ago, and it may have a superior side-effect profile. To date, however, there has been just a single published study reporting outcomes in a UK population. This study reports quality-of-life (QOL) outcomes and antacid use in patients undergoing MSA, with a particular focus on postoperative symptoms and those with severe reflux. A single-center cohort study was carried out to assess the QOL outcomes and report long-term safety outcomes in patients undergoing MSA. GERD-health-related quality of life (GERD-HRQL) and Reflux Symptom Index (RSI) scores were collected preoperatively, and immediately postoperatively, at 1-, 2-, 3-, and 5-year follow-up time points. All patients underwent preoperative esophagogastroduodenoscopy, impedance, and manometry. Two hundred and two patients underwent laparoscopic MSA over 9years. The median preoperative GERD-HRQL score was 31, and the median RSI score was 17. There was a reduction in all scores from preoperative values to each time point, which was sustained at 5-year follow-up; 13% of patients had a preoperative DeMeester score of >50, and their median preoperative GERD-HRQL and RSI scores were 32 and 15.5, respectively. These were reduced to 0 at the most recent follow-up. There was a significant reduction in antacid use at all postoperative time points. Postoperative dilatation was necessary in 7.4% of patients, and the device was removed in 1.4%. Erosion occurred in no patients. MSA is safe and effective at reducing symptom burden and improving QOL scores in patients with both esophageal and laryngopharyngeal symptoms, including those with severe reflux.

S1069 Endoscopic vs Surgical Procedures for Gastroesophageal Reflux Disease - A Network Meta-Analysis

Introduction: Various surgical fundoplication (SF) procedures have been the mainstay therapy for medication refractory GERD. Over the last couple of decades, interventional endoscopic procedures such as radiofrequency energy delivery with Stretta, endoscopic fundoplication (EF) procedures with EsophyX and GERDx systems, and laparoscopic magnetic sphincter augmentation (Linx), have emerged as alternative options. Objective of our study was to compare the efficacy of these various procedures. Methods: A comprehensive search of the available electronic databases was conducted, and only RCTs with our procedures of interest were included in our network meta-analysis using random-effects analysis. Outcomes of interest were lower esophageal sphincter pressure (LESP), esophagitis, cessation of use of proton pump inhibitors (PPIs), and percentage of time with a pH less than 4 on a 24-hour esophageal pH monitoring (% time pH< 4) at a follow-up of one year or less. Results: Thirty-one studies with a total of 4,371 patients were included in the analysis. EF and SF were associated with significantly higher LESP compared to PPI. There was no significant difference between EF and Nissen [Mean Difference (MD): 0.23, 95%CI: -7.01-7.48], anterior (MD: 1.76, 95% CI: -5.75-9.16) or Toupet (MD: 2.4, 95%CI: -4.94-9.75) fundoplications. In contrast, Stretta was inferior to Nissen (MD: -9.00, 95%CI: -14.55 - -3.45), Toupet (MD: -6.83, 95%CI: -12.50 - -1.55) and anterior (MD: -7.5, 95%CI: -13.35 - -1.71). Regarding % time pH< 4, EF was significantly better than Nissen (MD: 4.72, 95%CI: 0.71-8.73), but not significantly different from either Toupet (MD: 3.62, 95%CI: -1.90-9.14) or anterior (MD: -0.16, 95%CI: -6.29-5.96) fundoplications, and none of the procedures were significantly different from the PPI group. Cessation of PPI usage was significantly higher for endoscopic and surgical (only Linx) procedures compared to PPI group, but none of the procedures had significant differences when compared to each other. Endoscopic and surgical procedures (only SF) did not differ significantly from each other or from the PPI group in terms of presence of esophagitis at follow-up. (Figure) Conclusion: Efficacy of EF seemed comparable to SF in the short-term. Stretta was found to be inferior to all procedures in terms of LESP. Further studies focusing on head to head trials between EF and SF, and long term outcomes of EF are required to understand the place of EF in the treatment hierarchy.Figure 1.: A. Direct, indirect and network estimates of post-intervention lower esophageal sphincter pressures; B. Direct, indirect and network estimates of percentage of time with a esophageal pH less than 4; C. Forest plot of cessation of PPI usage at follow-up comparing various interventions to PPI alone

Laparoscopic magnetic sphincter augmentation device placement for patients with medically-refractory gastroesophageal reflux after sleeve gastrectomy.

The use of the magnetic sphincter augmentation (MSA) in patients with de novo or persistent gastroesophageal reflux disease (GERD) after sleeve gastrectomy has not been thoroughly investigated. The aim of this study is to evaluate the efficacy of MSA device placement in improving GERD symptoms and reducing anti-reflux medication usage in patients with persistent or de novo GERD after sleeve gastrectomy. This is a retrospective analysis of patients who underwent laparoscopic MSA device placement between January 2018 and July 2020 after sleeve gastrectomy. A total of twenty-two patients met inclusion criteria. Twenty patients were female (91%) and two patients were male (9%). All patients were taking anti-reflux medications daily to control GERD symptoms prior to MSA device placement. There was a significant improvement in the mean GERD-HRQL survey scores when comparing scores prior to (43.8) and after (16.7) MSA device placement (p < 0.0001). Majority of the patients did well without any post-operative complications (77%). Nearly 82% of patients were no longer taking any anti-acid medications after MSA device placement (p < 0.0485). There were no patients that required MSA device removals. There were no adverse events such as MSA device erosions or device-related mortalities. MSA device placement in patients with medically refractory GERD after sleeve gastrectomy is a safe and viable alternative to Roux-en-Y gastric bypass without conferring additional risks. We show an improvement in reflux symptoms after MSA device placement as evidenced by decreased post-operative GERD-HRQL scores, decreased anti-acid medication usage, and overall patient satisfaction with the procedure. Further prospective and comparative studies with longer term follow-up are needed to validate the use of MSA in patients who have undergone sleeve gastrectomy.

S148: Long-term patient-reported outcomes of laparoscopic magnetic sphincter augmentation versus Nissen fundoplication: a 5-year follow-up study.

Laparoscopic magnetic sphincter augmentation (MSA) has emerged as an alternative to laparoscopic Nissen fundoplication (LNF) for the management of symptomatic gastroesophageal reflux disease (GERD). While short-term outcomes of MSA compare favorably to those of LNF, direct comparisons of long-term outcomes are lacking. We hypothesized that the long-term patient-reported outcomes of MSA would be similar to those achieved with LNF. We tested this hypothesis in a retrospective cohort undergoing primary LNF or MSA between March 2013 and July 2015. The primary outcome was GERD-Health Related Quality of Life (GERD-HRQL) score at long-term follow-up relative to baseline. Secondary outcomes included dysphagia and bloating scores, proton-pump inhibitor (PPI) cessation, reoperations, and overall satisfaction with surgery. 70 patients (25 MSA, 45 LNF) met criteria for study inclusion. MSA patients had lower baseline BMI (median: 27.1 [IQR: 22.7-29.9] versus 30.4 [26.4-32.8], p = 0.02), lower total GERD-HRQL (26 [19-32] versus 34 [25-40], p = 0.02), and dysphagia (2 [0-3] versus 3 [1-4], p = 0.02) scores. Median follow-up interval exceeded 5 years (MSA: 68 [65-74]; LNF: 65months [62-69]). Total GERD-HRQL improved from 26 to 9 after MSA (p < 0.001) and from 34 to 7.5 after LNF (p < 0.01); these scores did not differ between groups (p = 0.68). Dysphagia (MSA: 1 [0-2]; LNF: 0 [0-2], p = 0.96) and bloating (MSA: 1.5 [0.5-3.0]; LNF: 3.0 [1.0-4.0], p = 0.08) scores did not show any statistically significant differences. Device removal was performed in 4 (16%) MSA patients and reoperation in 3 (7%) LNF patients. Eighty-nine percent of LNF patients reported satisfaction with the procedure, compared to 70% of MSA patients (p = 0.09). MSA appears to offer similar long-term improvement in disease-specific quality of life as LNF. For MSA, there was a trend toward reduced long-term bloating compared to LNF, but need for reoperation and device removal may be associated with patient dissatisfaction.

Results in Antireflux Surgery, an Analysis of Case-Controlled Cohorts versus Multicenter Studies and Meta-Analyses.

Introduction: With the advent of minimally invasive techniques, laparoscopic Nissen fundoplication and Toupet partial fundoplication have been very successful in the management of GERD. In the past 10 years, a number of very attractive new technologies have entered the market around therapeutic GERD-management such as Transoral Incisionless Gastroplication, other endoscopic plication techniques, and the implantation of the magnetic sphincter augmentation (MSA). These new technologies are excessively promoted by the respective companies, propagating their techniques as causing fewer side effects. The purpose of this paper is an overview on the successrates of these differently used techniques and technologies and, in addition, different study-designs. Methods: A literature review was performed searching for publications on laparoscopic fundoplication (LF), Transoral Incisionless Fundoplication (TIF), and laparoscopic MSA. The reported classified were separated according to their design into (group 1) large case-controlled series or comparative studies (n 100 cases) from high-volume centers and into (group 2) trials between different technologies of antireflux procedures, multicenter-studies, and meta-analyses of GERD-trials. Results: In total, 4030 abstract were screened according to the selected key words. Following the section criteria, 19 publications were selected and analyzed. Regarding group 1 and LF (selected studies 2565 patients), the morbidity ranged from 2.0-4.8 % of cases. With a follow-up time of 36-222 months most of these patients were followed 5 years. In group 2, more than 150 studies and several multicenter-registries were summarized in these 9 selected publications. The overall follow-up periods were substantially shorter with a range of 7-48 months. Conclusions: It can be concluded that special efforts in patient management in high volume centers and a vast experience may substantially contribute to excellent results for several antireflux techniques, which may reach a level of quality above results of registries and meta-analyses.

Loosening the belt on magnetic sphincter augmentation indications: does body mass index matter?

Magnetic sphincter augmentation (MSA) is an effective treatment for gastroesophageal reflux disease (GERD). However, the impact of obesity on MSA outcomes is unknown. The objective of this study was to evaluate the effectiveness of MSA in patients with GERD and obesity. A retrospective cohort study was performed of consecutive patients who underwent laparoscopic MSA at three high-volume centers from 2016 to 2019. Patients were grouped into four cohorts according to the World Health Organization body mass index (BMI) classification: BMI < 25 (normal weight), BMI 25-29.9 (overweight), BMI 30-34.9 (obese class I), and BMI > 35 (obese class II-III). Preoperative, operative, and postoperative data were compared between groups. A total of 621 patients underwent laparoscopic MSA during the study period. Follow-up with endoscopy or video esophagram was available for 361 patients (58%) with a median follow-up of 15.4months. Baseline characteristics of the groups were similar except the BMI > 35 group had more females and a higher preoperative median DeMeester score. There were no significant differences in outcomes between normal weight, overweight, and obese patient groups undergoing MSA. All groups experienced significant reductions in acid suppressive medication use, low GERD-HRQL scores, low DeMeester scores, few intraoperative and postoperative complications, and low rates of hiatal hernia recurrence after MSA. Magnetic sphincter augmentation is safe and effective in improving GERD symptoms, reducing esophageal acid exposure, and preventing hiatal hernia recurrence, irrespective of patient BMI. MSA should be considered an acceptable treatment option for obese patients with GERD.

Magnetic Sphincter Augmentation Outcomes in Severe Gastroesophageal Reflux Disease

Introduction: Outcomes of laparoscopic procedures for gastroesophageal reflux disease (GERD) are variable depending on surgical expertise and/or patient-related factors. Some procedures may be inadequate in patients with severe disease. Effectiveness of laparoscopic magnetic sphincter augmentation (MSA) has not been extensively tested in patients with severe disease.Methods: A prospectively collected database was analyzed to identify patients who underwent MSA at a single institution. Individuals who had previous esophago-gastric surgery were excluded. Severe GERD was defined as lower esophageal sphincter pressure <5 mmHg, distal esophageal amplitude <30 mmHg, Barrett's metaplasia, stricture or grade C-D esophagitis, and/or DeMeester score >50. Clinical characteristics and outcomes of patients with severe GERD were compared with those of patients with mild to moderate GERD who served as control group.Results: Over the study period, a total of 336 patients met the inclusion criteria, and 102 (30.4%) had severe GERD. The median follow-up was 24 months (IQR = 75) in severe GERD patients and 32 months (IQR = 84) in those with non-severe GERD. Patients with severe GERD had a higher rate of dysphagia and higher GERD-HRQL scores. After the MSA procedure, symptoms, health-related quality of life scores, and proton-pump inhibitors consumption significantly decreased in both groups (p < 0.05). No difference between groups was found in the prevalence of severe post-operative dysphagia, the need for endoscopic dilation or device removal, and the DeMeester score.Conclusion: Laparoscopic MSA is safe and effective in reducing symptoms, PPI use, and esophageal acid exposure also in patients with severe GERD.

SP5.1.8 Long term outcomes of laparoscopic magnetic sphincter augmentation for gastro-oesophageal reflux disease: High patient satisfaction with low dysphagia rates

Abstract Aims Laparoscopic magnetic sphincter augmentation (MSA) or LINX® procedure is gaining popularity as a treatment for gastro-oesophageal reflux disease. We looked at the long-term outcomes of this procedure with regards to its efficacy, in particular studying the dysphagia rate in relation to the LINX® device size. Methods Postal questionnaires were sent to all patients who underwent MSA procedure between 2012-2019 at a single institution. Patients were asked to quantify, as a percentage, their symptom resolution, proton pump inhibitor (PPI) intake and side effects. Results 124 patients (male:female ratio was 45:55) underwent MSA procedure, with 82 responding to the questionnaire. Patients' age range was 18-71 years (median 49). Over 90% of patients reported improvements in reflux symptoms with 75% reporting complete resolution. 67% of patients no longer required PPI medication, whilst 21% of patients had &amp;gt;50% reduction in their medication. Post-operative dysphagia occurred in 59% of patients at 3 months, which decreased to 16% at 1 year. There was no significant difference in size of LINX® device used between patients with dysphagia at ≥ 1 year versus those without dysphagia at ≥ 1 year (p = 0.554). In total 3 patients (2%) required explantation of the LINX® device. Overall 86% of patients rated their outcomes as satisfactory or very satisfactory. Conclusions Our 7 years of experience with laparoscopic MSA has demonstrated that this procedure is safe with high patient satisfaction rates. Dysphagia, although common in the early post-operative period, usually resolves within 3-6 months and is unrelated to LINX® device size.

Six to 12-year outcomes of magnetic sphincter augmentation for gastroesophageal reflux disease

The magnetic sphincter augmentation (MSA) device has been proven safe and effective in controlling typical reflux symptoms and esophageal acid exposure for up to 6-year follow-up. Longer term outcomes have not been reported yet. A prospectively maintained database was reviewed to assess long-term safety and efficacy of the laparoscopic MSA procedure at a single referral center. Gastro-Esophageal Reflux Disease-Health Related Quality of Life (GERD-HRQL), use of proton-pump inhibitors (PPI), and esophageal acid exposure were compared to baseline. Favorable outcomes were defined as ≥ 50% improvement of GERD-HRQL total score and PPI discontinuation. Between March 2007 and March 2020, 335 patients met the study inclusion criteria, and 124 of them were followed from 6 to 12 years after surgery (median 9 years, IQR 2). Mean total GERD-HRQL score significantly improved from 19.9 to 4.01 (p < 0.001), and PPI were discontinued by 79% of patients. The mean total percent time with pH < 4 decreased from 9.6% at baseline to 4.1% (p < 0.001), with 89% of patients achieving pH normalization. Independent predictors of a favorable outcome were age at intervention < 40 years (OR 4.17) and GERD-HRQL score > 15 (OR 4.09). We confirm long-term safety and efficacy of MSA in terms of symptom improvement, decreased drug dependency, and reduced esophageal acid exposure.

Clinical Outcomes and Predictors of Favorable Result after Laparoscopic Magnetic Sphincter Augmentation: Single-Institution Experience with More than 500 Patients

Magnetic sphincter augmentation (MSA) is a promising surgical treatment for patients with GERD. The aim of this study was to evaluate the outcomes of MSA in a large cohort of patients with GERD and to determine the factors predicting a favorable outcome. This was a retrospective review of prospectively collected data of 553 patients who underwent MSA at our institution in a 5-year period. Preoperative clinical, endoscopic, manometric, and pH data were used in a univariate analysis. This was followed by a regression multivariable analysis to determine the factors predicting a favorable outcome. Favorable outcome was defined as freedom from proton pump inhibitors and ≥50% improvement in Gastroesophageal Reflux Disease-Health-Related Quality of Life (GERD-HRQL) total score. At a mean (SD) follow-up of 10.3 (10.6) months after MSA, 92.7% of the patients were free of proton pump inhibitor use and 84% reported at least 50% improvement in their GERD-HRQL total score. The GERD-HRQL total score was improved from a mean (SD) baseline value of 33.8 (18.7) to 7.2 (9.0) (p < 0.001) and 76.1% of the patients had normalization of their esophageal acid exposure. Independent predictors of a favorable outcome after MSA included age younger than 45 years (odds ratio [OR] 4.2; 95% CI, 1.1 to 15.2; p= 0.0305), male sex (OR 2.5; 95% CI, 1.1 to 5.7; p= 0.0301), GERD-HRQL total score >15 (OR 7.5; 95% CI, 3.3 to 16.8; p < 0.0001), and abnormal DeMeester score (OR, 2.6; 95% CI, 1.1 to 5.7; p= 0.0225). In this largest single-institution series, we demonstrate that MSA implantation is associated with very good clinical and objective outcomes. Age younger than 45 years, male sex, GERD-HRQL total score >15, and abnormal DeMeester score are the 4 preoperative factors predicting a favorable outcome and can be used in patient counseling and MSA use.

P169 COMPARISON OF LAPAROSCOPIC TOUPET FUNDOPLICATION AND MAGNETIC SPHINCTER AUGMENTATION IN PATIENTS WITH 3-5 CM HIATUS HERNIA

Abstract Aim To compare quality of life in patients with large hiatus hernia undergoing laparoscopic Toupet fundoplication and magnetic sphincter augmentation. Background and Methods Laparoscopic Toupet fundoplication (LTF) and laparoscopic magnetic sphincter augmentation (MSA) have been compared in a previous retrospective study (Asti E et al, Medicine, 2016) in patients with small hiatal hernia (&lt;3 cm). There is no universal consensus in the use of MSA in patients with large hiatus hernia. This is an observational, retrospective, comparative cohort study. Patients with &lt;3 cm or &gt;5 cm hiatus hernia measured by endoscopy and barium swallow study and those with previous esophago-gastric surgery were excluded. The primary outcome was quality of life based on the Gastro-Esophageal Reflux Disease-Health Related Quality of Life (GERD-HRQL) questionnaire. Secondary outcomes were proton pump inhibitors (PPI) use, incidence of dysphagia and gas-related symptoms, and hiatus hernia recurrence rate. Results Between March 2007 and June 2018, 150 patients with GERD met the inclusion criteria; 88 underwent a LTF and 62 a MSA procedure. Both groups had similar preoperative features. The mean follow-up was 64 months and all patients were followed for at least one year after surgery. There was no statistically significant difference between LTF and MSA in GERD-HRQL scores (p=0.178), PPI use (p=0.327), gas-related symptoms (p=0.162), dysphagia (p=0.254), and reoperation rate (p=0.167). Conclusion Both LTF and MSA have similar safety profile and disease-specific quality of life in patients with large hiatal hernia.

Clinical Outcome and Predictors of a Favorable Result after Laparoscopic Magnetic Sphincter Augmentation: Single-Institution Experience with over 500 Patients with Reflux Disease

Clinical Outcome and Predictors of a Favorable Result after Laparoscopic Magnetic Sphincter Augmentation: Single-Institution Experience with over 500 Patients with Reflux Disease

417 Lack of Peristaltic Reserve as Detected by Multiple Rapid Swallows on HRM Predicts Development of Dysphagia Following Magnetic Sphincter Augmentation for GERD

INTRODUCTION: Magnetic Sphincter Augmentation (MSA) is an antireflux procedure that can be performed on patients with normal esophageal motor function. The most common side-effect of MSA is dysphagia, which occurs in 34-38% of patients and may require dilation (Lipham JC et al, 2015). Multiple rapid swallows (MRS) is a provocative maneuver during high resolution esophageal manometry (HRM) that assesses peristaltic reserve; impaired MRS has previously been shown to predict the development of dysphagia following fundoplication (Shaker A et al, 2013). We hypothesized that impaired MRS may predict which patients experience dysphagia following laparoscopic MSA. METHODS: Retrospective review of all patients who underwent MSA at a tertiary academic center from May 2015 to May 2018. All patients completed a standardized esophageal questionnaire and pre-operative HRM which included MRS. Peristaltic augmentation with MRS was defined as a ratio &gt;1 of the distal contractile integral (DCI) following MRS and the median DCI of the 10 baseline wet swallows. Demographics, MSA implant size, and symptom data from post-operative follow-up of at least 6 months was gathered on all patients. RESULTS: 29 patients (age 52 ± 17 years, 59% female, BMI 25 ± 4.2 kg/m2) were identified. Postoperatively, 15 patients developed dysphagia, 9 of them within the first 2 weeks. 5 patients required balloon dilatation for symptom relief. Among the patients that did not develop dysphagia, peristaltic augmentation with MRS was present in 42.9% compared to 6.7% of patients who developed dysphagia (P-value 0.03). 40% of the patients that required balloon dilatation exhibited complete absence of any smooth muscle contraction following MRS (DCI = 0). Having a small MSA implant (13 or 14 beads) versus a large MSA implant (15, 16 or 17 beads) trended towards an association with developing dysphagia (47% versus 29%, P-value 0.18). The DCI ratio of MRS/wet swallows that predicted development of dysphagia following MSA was 0.59. CONCLUSION: Intact peristaltic reserve, as assessed by augmented contraction following MRS, was protective of developing dysphagia following MSA. MRS should be given important consideration in the evaluation of patients under consideration for antireflux surgery specifically with regards to counseling patients on their individual risk of developing dysphagia and the potential need for additional procedures such as dilation.

A570 Combined Magnetic Sphincter Augmentation and Hiatal Hernia Repair for Treatment of Refractory GERD after Sleeve Gastrectomy

Magnetic sphincter augmentation (MSA) has been shown to be a safe and effective surgical option in treating medically refractory GERD. However, there is limited data evaluating the efficacy of this technique in patients with previous laparoscopic sleeve gastrectomy (LSG) and concurrent hiatal hernia. We present a novel case of managing GERD with laparoscopic MSA and hiatal hernia repair after LSG.

A560 Laparoscopic magnetic sphincter augmentation system for the treatment of severe GERD post Sleeve Gastrectomy

The laparoscopic Magnetic Sphincter Augmentation System (MSA) is a surgical technique with mid-term evidence demonstrating efficacy in the treatment of medically refractory or chronic gastroesophageal reflux disease (GERD). We present the first series of cases with severe GERD post Sleeve, that underwent this surgery. To verify the efficacy of the MSA for the treatment of pathological GERD in patients with previous sleeve gastrectomy, with no weight regain.

Magnetic Sphincter Augmentation Superior to Proton Pump Inhibitors for Regurgitation in a 1-Year Randomized Trial

Regurgitative gastroesophageal reflux disease (GERD) refractive to medical treatment is common and caused by mechanical failure of the anti-reflux barrier. We compared the effects of magnetic sphincter augmentation (MSA) with those of proton-pump inhibitors (PPIs) in a randomized trial. Patients with moderate to severe regurgitation (assessed by the foregut symptom questionnaire) despite once-daily PPI therapy (n= 152) were randomly assigned to groups given twice-daily PPIs (n= 102) or laparoscopic MSA (n= 50) at 20 sites, from July 2015 through February 2017. Patients answered questions from the foregut-specific reflux disease questionnaire and GERD health-related quality of life survey about regurgitation, heartburn, dysphagia, bloating, diarrhea, flatulence, and medication use, at baseline and 6 and 12 months after treatment. Six months after PPI therapy, MSA was offered to patients with persistent moderate to severe regurgitation and excess reflux episodes during impedance or pH testing on medication. Regurgitation, foregut scores, esophageal acid exposure, and adverse events were evaluated at 1 year. Patients in the MSA group and those who crossed over to the MSA group after PPI therapy (n= 75) had similar outcomes. MSA resulted in control of regurgitation in 72/75 patients (96%); regurgitation control was independent of preoperative response to PPIs. Only 8/43 patients receiving PPIs (19%) reported control of regurgitation. Among the 75 patients who received MSA, 61 (81%) had improvements in GERD health-related quality of life improvement scores (greater than 50%) and 68 patients (91%) discontinued daily PPI use. Proportions of patients with dysphagia decreased from 15% to 7% (P <.005), bloating decreased from 55% to 25%, and esophageal acid exposure time decreased from 10.7% to 1.3% (P < .001) from study entry to 1-year after MSA (Combined P<.001). Seventy percent (48/69) of patients had pH normalization at study completion. MSA was not associated with any peri-operative events, device explants, erosions, or migrations. In a prospective study, we found MSA to reduce regurgitation in 95% of patients with moderate to severe regurgitation despite once-daily PPI therapy. MSA is superior to twice-daily PPIs therapy in reducing regurgitation. Relief of regurgitation is sustained over 12 months. ClinicalTrials.gov no: NCT02505945.

Comparison of surgical payer costs and implication on the healthcare expenses between laparoscopic magnetic sphincter augmentation (MSA) and laparoscopic Nissen fundoplication (LNF) in a large healthcare system

IntroductionMagnetic sphincter augmentation (MSA) is a promising antireflux surgical treatment. The cost associated with the device may be perceived as a drawback by payers, which may limit the adoption of this technique. There are limited data regarding the cost of MSA in the management of reflux disease. The aims of the study were to report the clinical outcome and quality of life measures in patients after MSA and to compare the pharmaceutical and procedure payer costs and the disease-related and overall expense of MSA compared to laparoscopic Nissen fundoplication (LNF) from a payer perspective.Methods and proceduresThis prospective observational study was performed in conjunction with the region’s largest health insurance company. Data were collected on patients who underwent MSA over a 2-year period beginning in September 2015 at the study network hospitals. The LNF comparison group was procured from members’ claims data of the payer. Inclusion was predicated by patients having continuous coverage during study period. The total procedural reimbursement and the disease-related and overall medical claims submitted up to 12 months prior to surgery and up to 12 months following surgery were obtained. The payer reimbursement data are presented as allowed cost per member per month (PMPM). These values were then compared between groups.ResultsThere were 195 patients who underwent MSA and 1131 that had LNF. MSA results in comparable symptom control, PPI elimination rate, and quality of life measures compared to values reported for LNF in the literature. The median (IQR) reimbursement of surgery was $13,522 (13,195–14,439) for those who underwent MSA and $13,388 (9951–16,261) for patients with LNF, p = 0.02. In patients who underwent MSA, the median reimbursement related to the upper gastrointestinal disease was $ 305 PMPM, at 12 months prior to surgery and $ 104 at 12 months after surgery, representing 66% decrease in cost. These values were $ 233 PMPM and $126 PMPM for patients who underwent LNF, representing a 46% decrease (p = 0.0001). At 12 months following surgery, the reimbursement for overall medical expenses had decreased by 10.7% in the MSA group and 1.4% in the LNF group when compared to the preoperative baseline reimbursement. The reimbursement for PPI use after surgery showed a 95% decrease in the MSA group and 90% among LNF group when compared to the preoperative baseline (p = 0.10).ConclusionWhen compared with LNF, MSA results in a reduction of disease-related expenses for the payer in the year following surgery. While MSA is associated with a higher procedural payer cost compared to LNF, payer costs may offset due to reduction in the expenses after surgery.

Short-Term Outcomes Predict Long-Term Satisfaction in Patients Undergoing Laparoscopic Magnetic Sphincter Augmentation.

Laparoscopic magnetic sphincter augmentation (MSA) has been shown to be efficacious therapy for gastroesophageal reflux disease (GERD) refractory to maximal medical management. Herein, we present our experience with this procedure and an analysis of our outcomes. Medical records were retrospectively reviewed of 98 patients who underwent laparoscopic MSA for GERD at a single institution from 2012 to 2016. Symptoms were assessed with gastroesophageal reflux disease-health-related quality of life (GERD-HRQL) questionnaire. Objective testing included pH testing, manometry, endoscopy, and upper GI series. Postimplantation interventions were recorded. Median follow-up was 46 months. Median preoperative DeMeester score was 32 (interquartile range 21-46). Esophagitis was present in 18%. Hiatal hernia was present in 59%. Operation required full hiatal dissection in 16%. There were no intraoperative complications. Mean hospital stay postimplantation was 18 hours. Reoperative intervention with device explant was necessary in 5 cases, one of which was for intraluminal device erosion. Median GERD-HRQL scores were 25 preoperatively, 8 in short-term follow-up at median 1 month, and 5 in long-term follow-up at median 46 months. Improvement in GERD-HRQL scores was statistically significant with both short and long term compared with preoperative (P < .05), but no different between short- and long-term follow-up. Daily bothersome dysphagia was present in 19 patients preoperatively and in 9 at long-term follow-up. Laparoscopic MSA is associated with excellent outcomes with decrease in GERD-HRQL scores in short term that are durable to longer term follow-up, and with low rates of new-onset dysphagia.