Efficacy Of Magnetic Sphincter Augmentation Research Articles

Is magnetic sphincter augmentation indicated in patients with laryngopharyngeal reflux?

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.

Magnetic sphincter augmentation for gastroesophageal reflux in overweight and obese patients.

Magnetic sphincter augmentation (MSA) is a successful treatment option for chronic gastroesophageal reflux disease; however, there is a paucity of data on the efficacy of MSA in obese and morbidly obese patients. To assess the relationship between obesity and outcomes after MSA, we conducted a literature search using MeSH and free-text terms in MEDLINE, EMBASE, Cochrane and Google Scholar. The included articles reported conflicting results regarding the effect of obesity on outcomes after MSA. Prospective observational studies with larger sample sizes and less statistical bias are necessary to understand the effectiveness of MSA in overweight and obese patients.

Feasibility and Efficacy of Magnetic Sphincter Augmentation for the Management of Gastroesophageal Reflux Disease Post-Sleeve Gastrectomy for Obesity

BackgroundPatients with medically intractable GERD after laparoscopic sleeve gastrectomy (LSG) have limited surgical options. Fundoplication is difficult post-LSG. Roux-en-Y gastric bypass may be used as a conversion procedure but is more invasive with potential for serious complications. Magnetic sphincter augmentation (MSA) is a less invasive GERD treatment alternative. The objective of this study was to assess safety and efficacy outcomes of MSA after LSG.MethodsThe primary outcome of this observational, multicenter, single-arm prospective study was the rate of serious device and/or procedure-related adverse events (AEs). The efficacy of the LINX device was measured comparing baseline to 12-month post-implant reductions in distal acid exposure, GERD-HRQL score, and average daily PPI usage.ResultsThirty subjects who underwent MSA implantation were followed 12 months post-implant. No unanticipated adverse device effects were observed. There were two adverse events deemed serious (dysphagia, pain, 6.7%) which resolved without sequelae. GERD-HRQL scores showed significant improvement (80.8%, P < 0.001), and reduction in daily PPI usage was seen (95.8%, P < 0.001). Forty-four percent of subjects demonstrated normalization or > = 50% reduction of total distal acid exposure time (baseline 16.2%, 12 months 11%; P = 0.038).ConclusionsPost-LSG, MSA showed an overall improvement of GERD symptoms, and reduction in PPI use with explants within anticipated range along with improvement in distal esophageal acid exposure time.Graphical

Efficacy of Magnetic Sphincter Augmentation Across the Spectrum of GERD Disease Severity

The performance and durability of various types of fundoplication are variable when stratified by disease severity. To date, magnetic sphincter augmentation (MSA) has not been evaluated in this context. We designed this study to determine the efficacy of MSA in the treatment of severe GERD. Guided by previous studies, a DeMeester score (DMS) ≥ 50 was used as a cutoff point to define severe reflux disease. Subjects were divided into 2 groups using this cutoff, and outcomes of severe cases were compared with those with less severe disease (DMS < 50). A total of 334 patients underwent MSA. Patients with severe disease had a higher mean preoperative DMS compared with those with mild to moderate GERD (79.2 [53.2] vs 22.8 [13.7], p < 0.0001). At a mean postoperative follow-up of 13.6 (10.4) months, there was no difference between the mean GERD Health-Related Quality of Life (HRQL) total scores in patients with severe disease compared with those with less severe GERD (8.8 [10] vs 9.2 [10.8], p= 0.9204). Postoperative mean DMS was not different between groups (17.3[23.0] vs 14.1[33.9], p= 0.71), and there was no difference in the prevalence of esophagitis (p= 0.52). Patients with severe disease were less likely to be free from use of proton pump inhibitors after surgery (85% vs 93.1%, p= 0.041). There were similar rates of postoperative dysphagia (10% vs 14%, p= 0.42) and need for device removal (3% vs 5%, p= 0.7463). MSA is an effective treatment in patients with severe GERD and leads to significant clinical improvement across the spectrum of disease severity, with few objective outcomes being superior in patients with mild-to-moderate reflux disease.

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.

Application of magnetic sphincter augmentation for treating gastroesophageal reflux disease

The lower esophageal sphincter incompetent is fundamental pathological abnormality of gastroesophageal reflux disease (GERD). Magnetic sphincter augmentation (MSA) is a magnetic bracelet, which designed to be placed surgically around the exterior surface of the distal esophagus. In the closed position, the highest attractive force between the magnetic beads would reinforce the lower esophageal sphincter to strengthen the antireflux barrier. Animal experiments and clinical trials have verified the safety and efficacy of MSA in GERD patients. For refractory GERD and GERD with huge hernia, MSA can also achieve acceptable clinical effect. Comparative researches appeared that there is no significantly difference in clinical effect between Nissen fundoplication and MSA. MSA could preserve the function of belching and vomiting postoperatively, and it can be implanted with the use of standard laparoscopic techniques. The long-term effect of MSA is satisfactory with less complications, which has been carried out in China since 2018. It can be predicted that MSA will play an important role in the treatment of GERD in the future.

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.

Efficacy of Magnetic Sphincter Augmentation versus Nissen Fundoplication for Gastroesophageal Reflux Disease in Short Term: A Meta-Analysis.

Background. The efficacy of Magnetic Sphincter Augmentation (MSA) and its outcomes for Gastroesophageal Reflux Disease (GERD) are uncertain. Therefore, we aimed to summarize and analyze the efficacy of two treatments for GERD. Methods. The meta-analysis search was performed, using four databases. All studies from 2005 to 2016 were included. Pooled effect was calculated using either the fixed or random effects model. Results. A total of 4 trials included 624 patients and aimed to evaluate the differences in proton-pump inhibitor use, complications, and adverse events. MSA had a shorter operative time (MSA and NF: RR = −18.80, 95% CI: −24.57 to −13.04, and P = 0.001) and length of stay (RR = −14.21, 95% CI: −24.18 to −4.23, and P = 0.005). Similar proton-pump inhibitor use, complication (P = 0.19), and severe dysphagia for dilation were shown in both groups. Although there is no difference between the MSA and NF in the number of adverse events, the incidence of postoperative gas or bloating (RR = 0.71, 95% CI: 0.54–0.94, and P = 0.02) showed significantly different results. However, there is no significant difference in ability to belch and ability to vomit. Conclusions. MSA can be recommended as an alternative treatment for GERD according to their short-term studies, especially in main-features of gas-bloating, due to shorter operative time and less complication of gas or bloating.

LINX® magnetic esophageal sphincter augmentation versus Nissen fundoplication for gastroesophageal reflux disease: a systematic review and meta-analysis.

The LINX® magnetic sphincter augmentation system (MSA) is a surgical technique with short-term evidence demonstrating efficacy in the treatment of medically refractory or chronic gastroesophageal reflux disease (GERD). Currently, the Nissen fundoplication is the gold-standard surgical treatment for GERD. We are the first to systematically review the literature and perform a meta-analysis comparing MSA to the Nissen fundoplication. A comprehensive search of electronic databases (e.g., MEDLINE, EMBASE, SCOPUS, Web of Science and the Cochrane Library) using search terms "Gastroesophageal reflux or heartburn" and "LINX or endoluminal or magnetic" and "fundoplication or Nissen" was completed. All randomized controlled trials, non-randomized comparison study and case series with greater than 5 patients were included. Five hundred and forty-seven titles were identified through primary search, and 197 titles or abstracts were screened after removing duplicates. Meta-analysis was performed on postoperative quality of life outcomes, procedural efficacy and patient procedural satisfaction. Three primary studies identified a total of 688 patients, of whom 273 and 415 underwent Nissen fundoplication and MSA, respectively. MSA was statistically superior to LNF in preserving patient's ability to belch (95.2 vs 65.9%, p<0.00001) and ability to emesis (93.5 vs 49.5%, p<0.0001). There was no statistically significant difference between MSA and LNF in gas/bloating (26.7 vs 53.4%, p=0.06), postoperative dysphagia (33.9 vs 47.1%, p=0.43) and proton pump inhibitor (PPI) elimination (81.4 vs 81.5%, p=0.68). Magnetic sphincter augmentation appears to be an effective treatment for GERD with short-term outcomes comparable to the more technically challenging and time-consuming Nissen fundoplication. Long-term comparative outcome data past 1year are needed in order to further understand the efficacy of magnetic sphincter augmentation.

Efficacy of magnetic sphincter augmentation in patients with large hiatal hernias.

Magnetic sphincter augmentation (MSA) has demonstrated long-term safety and efficacy in the treatment of patients with gastroesophageal reflux (GERD), but its efficacy in patients with large hiatal hernias has yet to be proven. The aim of our study was to assess outcomes of MSA in patients with hiatal hernias ≥3cm. We retrospectively reviewed all patients who underwent MSA at our institutions over a 6-year period. Information obtained consisted of patient demographics, symptoms of GERD, preoperative GERD Health-Related Quality-of-Life (HRQL) scores, perioperative details, and implantation of the MSA device. Primary endpoints included postoperative GERD-HRQL scores, proton-pump inhibitor (PPI) use, symptom change, and procedure-related complications. A large hiatal hernia was defined as a hernia measuring ≥3cm by intraoperative measurement. A total of 192 patients were reviewed. Median follow-up was 20months (3-75months). Mean GERD-HRQL scores in the overall population before and after MSA were 18.9 and 5.0, respectively (p<0.001). In the majority of patients symptoms improved or resolved (N=177, p<0.001). Fifty-two patients (27.0%) had a hiatal hernia ≥3cm (range 3-7cm). Their mean GERD-HRQL score decreased from 20.5 to 3.6 (p<0.001) following MSA. When compared to patients with smaller hernias, patients with large hiatal hernias had decreased postoperative PPI requirement (9.6 vs. 26.6%, p=0.011) and lower mean postoperative GERD-HRQL scores (3.6 vs. 5.6, p=0.027). The percent of patients requiring postoperative intervention for dysphagia was similar (13.5 vs. 17.9%, p=0.522), as was the incidence of symptom resolution or improvement (98.1 vs. 91.3%, p=0.118). MSA in patients with large hiatal hernias demonstrates decreased postoperative PPI requirement and mean GERD-HRQL scores compared to patients with smaller hernias. The incidence of symptom resolution or improvement and the percentage of patients requiring intervention for dysphagia are similar. Short-term outcomes of MSA are encouraging in patients with gastroesophageal reflux disease and large hiatal hernias.

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.

Multi-institutional outcomes using magnetic sphincter augmentation versus Nissen fundoplication for chronic gastroesophageal reflux disease.

Magnetic sphincter augmentation (MSA) has emerged as an alternative surgical treatment of gastroesophageal reflux disease (GERD). The safety and efficacy of MSA has been previously demonstrated, although adequate comparison to Nissen fundoplication (NF) is lacking, and required to validate the role of MSA in GERD management. A multi-institutional retrospective cohort study of patients with GERD undergoing either MSA or NF. Comparisons were made at 1year for the overall group and for a propensity-matched group. A total of 415 patients (201 MSA and 214 NF) underwent surgery. The groups were similar in age, gender, and GERD-HRQL scores but significantly different in preoperative obesity (32 vs. 40%), dysphagia (27 vs. 39%), DeMeester scores (34 vs. 39), presence of microscopic Barrett's (18 vs. 31%) and hiatal hernia (55 vs. 69%). At a minimum of 1-year follow-up, 354 patients (169 MSA and 185 NF) had significant improvement in GERD-HRQL scores (pre to post: 21-3 and 19-4). MSA patients had greater ability to belch (96 vs. 69%) and vomit (95 vs. 43%) with less gas bloat (47 vs. 59%). Propensity-matched cases showed similar GERD-HRQL scores and the differences in ability to belch or vomit, and gas bloat persisted in favor of MSA. Mild dysphagia was higher for MSA (44 vs. 32%). Resumption of daily PPIs was higher for MSA (24 vs. 12, p=0.02) with similar patient-reported satisfaction rates. MSA for uncomplicated GERD achieves similar improvements in quality of life and symptomatic relief, with fewer side effects, but lower PPI elimination rates when compared to propensity-matched NF cases. In appropriate candidates, MSA is a valid alternative surgical treatment for GERD management.