Safety Of Magnetic Sphincter Augmentation Research Articles

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.

MAGNETIC SPHINCTER AUGMENTATION DEVICE FOR GASTROESOPHAGEAL REFLUX DISEASE: EFFECTIVE, BUT POSTOPERATIVE DYSPHAGIA AND RISK OF EROSION SHOULD NOT BE UNDERESTIMATED. A SYSTEMATIC REVIEW AND META-ANALYSIS.

Magnetic ring (MSA) implantation in the esophagus is an alternative surgical procedure to fundoplication for the treatment of gastroesophageal reflux disease. The aim of this study was to analyse the effectiveness and safety of magnetic sphincter augmentation (MSA) in patients with gastroesophageal reflux disease (GERD). A systematic literature review of articles on MSA was performed using the Medical Literature Analysis and Retrieval System Online (Medline) database between 2008 and 2021, following the Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA) guidelines. A random-effect model was used to generate a pooled proportion with 95% confidence interval (CI) across all studies. A total of 22 studies comprising 4,663 patients with MSA were analysed. Mean follow-up was 27.3 (7-108) months. The weighted pooled proportion of symptom improvement and patient satisfaction were 93% (95%CI 83-98%) and 85% (95%CI 78-90%), respectively. The mean DeMeester score (pre-MSA: 34.6 vs. post-MSA: 8.9, p=0.03) and GERD-HRQL score (pre-MSA: 25.8 vs. post-MSA: 4.4, p<0.0001) improved significantly after MSA. The proportion of patients taking proton pump inhibitor (PPIs) decreased from 92.8 to 12.4% (p<0.0001). The weighted pooled proportions of dysphagia, endoscopic dilatation and gas-related symptoms were 18, 13, and 3%, respectively. Esophageal erosion occurred in 1% of patients, but its risk significantly increased for every year of MSA use (odds ratio - OR 1.40, 95%CI 1.11-1.77, p=0.004). Device removal was needed in 4% of patients. Although MSA is a very effective treatment modality for GERD, postoperative dysphagia is common and the risk of esophageal erosion increases over time. Further studies are needed to determine the long-term safety of MSA placement in patients with GERD.

Magnetic sphincter augmentation in treating refractory gastroesophageal reflux disease: A systematic review and meta-analysis.

In this systematic review and meta-analysis we aimed to determine the efficacy and safety of magnetic sphincter augmentation (MSA) in the management of refractory gastroesophageal reflux disease (rGERD). Literature search was conducted in PubMed, the Cochrane Library, EMBASE, Web of Science, OpenGrey and ClincalTrials.gov for single-arm studies evaluating the efficacy and safety of MSA in rGERD or comparative studies with proton pump inhibitor (PPI) or laparoscopic Nissen fundoplication (LNF) serving as the control published until April 2020. Primary outcome was the rate of postoperative PPI use, and secondary outcomes included postoperative GERD-health-related quality of life (GERD-HRQL), normalization of acid exposure time (AET) and incidence of procedure-related adverse events (AE). Ten single-arm studies, one randomized controlled trial and three cohort studies involving 1138 participants were included. Post-MSA PPI withdrawal, significant GERD-HRQL improvement and AET normalization were achieved in 87.0%, 88.0% and 75.0% of the patients, respectively. The incidence of postoperative dysphagia was 29% and endoscopic dilation was required in 7.4% of patients undergoing MSA. MSA showed a better efficacy in symptom control than PPI (PPI cessation: 91% vs 0%; GERD-HRQL improvement: 81% vs 8%) and similar effectiveness but a lower risk of gas-bloat syndrome (risk ratio [RR] 0.69, 95% confidence interval [CI] 0.51-0.93, P=0.01) and better reserved ability to belch (RR 1.48, 95% CI 0.76-2.86, P=0.25) compared with LNF. MSA was an effective and safe therapy for rGERD. Well-designed randomized trials that compare the efficacy of MSA with other therapies are needed.

Clinical efficacy and safety of magnetic sphincter augmentation (MSA) and transoral incisionless fundoplication (TIF2) in refractory gastroesophageal reflux disease (GERD): a systematic review and meta-analysis.

Abstract Background and study aims Proton pump inhibitors (PPI) are effective medical therapy options for gastro-esophageal reflux disease (GERD). However, 20 % to 40 % of patients report symptoms despite taking daily PPI. Transoral incisionless fundoplication (TIF2) and magnetic sphincter augmentation (MSA) are less invasive options for the treatment of refractory GERD and are increasingly gaining popularity. Methods We conducted a comprehensive search of several databases to identify relevant studies. Our primary aim was to compare the efficacy of both interventions reported as improvement in Gastroesophageal Reflux Disease-Health Related Quality of Life (GERD-HRQL) score, overall patient satisfaction, improvement in post-procedure regurgitation, and fraction of patients completely off PPI therapy at follow up. Results Twenty-four studies with 1942 patients were included in the final analysis. Both MSA and TIF2 had comparable technical success and clinical success based on improvement in GERD-HRQL scores i. e. 98.8 % (CI 95.6,99.7) vs 98.5 % (CI 95.7,99.5) and 80.4 % (CI 66,89.6) vs 77.7 % (CI 64.1,87.2), respectively. A significantly greater proportion of patients reported improvement in regurgitation, i. e. 91.1 % (CI 83.8,95.3) vs 73.1 % (CI 62.5,81.7) and were able to completely discontinue PPI therapy with MSA compared to TIF2 i. e. 91.3 % (CI 81.5,96.2) vs 63.8 % (CI 51.6,74.4). Patients’ BMI and presence of a hiatal hernia did not have any effect on procedural outcomes. Conclusion Both procedures performed at par when comparing clinical success in terms of improvement in GERD-HRQL scores. In terms of overall patient satisfaction, post procedure regurgitation and cumulative number of patients off PPI therapy, MSA outperforms TIF2.

Safety of magnetic sphincter augmentation in patients with prior bariatric and anti-reflux surgery.

Magnetic sphincter augmentation (MSA) has been recognized as an effective treatment option for patients with gastroesophageal reflux disease. The feasibility of MSA in patients with prior gastric surgery has not been well established. This study aims to evaluate the safety and efficacy of MSA in patients with prior gastric surgery including bariatric and other anti-reflux operations. A prospectively gathered registry approved by the institutional review board for patients undergoing anti-reflux surgery was retrospectively reviewed. All patients who underwent MSA were included. The patients were divided into two groups based on the presence of prior gastric surgeries compared to those without. Endpoints collected include differences between the two groups in their preoperative evaluation, perioperative course, and postoperative effectiveness. A total of 103 patients underwent MSA where 82 patients (80%) had no prior gastric surgery and 21 patients (20%) had prior gastric surgery. The prior gastric surgery group included 10 patients with prior anti-reflux surgery, 11 patients with prior bariatric surgery. Perioperative factors were higher in the prior gastric surgery group including operating room time (135min vs. 93min, p = < 0.001), number of beads used (16 vs. 14, p = < 0.001), and percent of patients staying overnight (47% vs. 5%, p = < 0.001). There was no difference in several factors of their preoperative evaluation including preoperative GERD-HRQL and RSI scores, hiatal hernia presence, or DeMeester score. Post-operative GERD-HRQL and RSI scores were not different as well as patient satisfaction, patients resuming PPI use, and device explant rate. This study demonstrates equivalent outcomes with integration of MSA in patients with prior gastric surgery in comparison to patients without prior gastric surgery. However, these surgeries are longer, require larger devices, and patients are more likely to stay overnight.

Revaluation of the efficacy of magnetic sphincter augmentation for treating gastroesophageal reflux disease.

Gastroesophageal reflux disease (GERD) is a prevalent disease which severely impacts the quality of life of the patients. The surgical options are limited to such patients who are not satisfied with medical therapies. Magnetic sphincter augmentation (MSA) is a new antireflux surgical technique for treating GERD, which could physiologically reinforce the lower esophageal sphincter by magnetic force. Many clinical and animal studies have focused on this new therapy. The purpose of this work was to review the feasibility, efficacy and safety of MSA as a new treatment for GERD. We performed a PubMed database search for the MSA and GERD-related studies between 2008 and September 22, 2015. One animal study, two case reports and fifteen clinical studies were identified in this review. The MSA device reinforces the lower esophageal sphincter to antireflux via magnetic force. The feasibility of this laparoscopic technique has been proved by the experimental and clinical studies. The clinical studies demonstrate that MSA treatment could effectively reduce the percent time of esophageal acid exposure (pH<4) and improve the GERD health-related quality of life score. The operation time of MSA is shorter than that of the Nissen fundoplication, and the efficacy of MSA treatment is equal to that of fundoplication. The most frequent postoperative complication is dysphagia, and the majority of them could be self-resolved with conservative treatment. MSA (or LINX) devices provide an alternative surgical option for the patients who had failed in medical therapy. This review of the current literatures demonstrates that MSA is as effective as the medical and conventional surgical therapies. In the future, MSA will play a more important role in the treatment of GERD because of its unique advantage.

Laparoscopic Magnetic Sphincter Augmentation vs Laparoscopic Nissen Fundoplication: A Matched-Pair Analysis of 100 Patients

The efficacy and safety of magnetic sphincter augmentation (MSA) with the LINX device (Torax Medical) has been reported in several short-and long-term studies, rivaling historic results of laparoscopic Nissen fundoplication (LNF), but with fewer side effects. However, there have been no studies comparing patients with similar disease to validate these results. We conducted a retrospective analysis of 1-year outcomes of patients undergoing MSA and LNF from June 2010 to June 2013. Patients were matched using propensity scores incorporating multiple preoperative variables. Outcomes were measured by GERD Health Related Quality of Life scores, proton-pump inhibitor use, satisfaction, and complications. One hundred and seventy-nine patients met inclusion criteria, 62 MSA and 117 LNF. Propensity score matching identified 50 patients in both groups using the "best-fit" model with a caliper of 0.5 SD. At 1 year after surgery, both groups had similar GERD Health Related Quality of Life scores (4.2 MSA and 4.3 LNF; p = 0.897) and proton-pump inhibitor use (17% of MSA and 8.5% of LNF; p = 0.355). Although there was no difference in the number of patients reporting mild gas and bloating (27.6% MSA and 27.6% LNF; p = 1.000), there were no patients with severe gas and bloating in the MSA group compared with 10.6% in the LNF group (p = 0.022). More LNF patients were unable to belch (8.5% of MSA and 25.5% of LNF; p = 0.028) or vomit (4.3% of MSA and 21.3% of LNF; p = 0.004). The incidence of postoperative dysphagia was similar between the groups (46.8% MSA and 44.7% LNF; p = 0.766). Analogous GERD patients had similar control of reflux symptoms after both MSA and LNF. The inabilities to belch and vomit were significantly fewer with MSA, along with a significantly lower incidence of severe gas-bloat symptoms. These results support the use of MSA as first-line therapy in patients with mild to moderate GERD.