Magnetic Sphincter Augmentation Device Research Articles

The effectiveness and safety of the anti gastroesophageal reflux system in the treatment of gastroesophageal reflux disease: a single center study of 23 cases

Objective: To evaluate the safety and efficacy of domestically produced magnetic sphincter augmentation (MSA) for gastroesophageal reflux disease. Method: This study is a prospective cohort study. Patients with typical heartburn and reflux symptoms (at least partial response to proton pump inhibitors), abnormal esophageal acid exposure and normal esophageal peristalsis were included, prospectively in the Department of Gastroesophageal Surgery, Rocket Force Characteristic Medical Center from June 2019 to September 2022. Patients with hiatal hernia >2 cm and severe esophagitis were excluded. The MSA was wrapped around the distal esophagus after esophageal hiatus repair by laparoscopy. A postoperative questionnaire survey was conducted to assess the relief of symptom, complications, the discontinuation rate of proton pump inhibitor, and surgical satisfaction. Gastroscopy, high-resolution esophageal pressure measurement, and pH value impedance monitoring were also reviewed. The pre- and postoperative rates were compared using the McNeinar χ2 test. Result: Currently, 23 patients with gastroesophageal reflux disease were enrolled and underwent MSA surgery. There were 20 males and 3 females, aged (M (IQR)) 48 (14) years (range: 25 to 64 years). All cases were successfully implanted with MSA. Subjective indicators were followed for 17 (18) months (range: 14 to 53 months), while objective indicators were followed for 17 (1) months (range: 12 to 23 months). The postoperative gastrointestinal and extraesophageal symptom scores showed a significant decrease compared to preoperative levels as follows: the degree of subjective relief of overall digestive symptoms was 90 (20)% (range:0~100%), the degree of subjective relief of overall respiratory symptoms was 100(10)% (range: 10%~100%), the overall satisfaction rate was 83% (19/23), the proton pump inhibitor discontinuation rate was 70% (16/23). The proportion of esophagitis has decreased from 44% (10/23) to 9% (2/23) (κ=0.169, P=0.039), The Hill grade of gastroesophageal valve morphology improved from 1 case of grade Ⅰ, 5 cases of grade Ⅱ, 10 cases of grade Ⅲ, and 7 cases of grade Ⅲ preoperative to 22, 1, 0, and 0 cases postoperative. The proportion of lower esophageal sphincter pressure below normal has decreased from 70% (16/23) to 35% (8/23) (κ=0.170, P=0.012). There were 21 patients who restored normal esophageal acid exposure. Eleven patients had mild long-term dysphagia, but it didn't affect their daily life. No postoperative device migration, erosion, or secondary surgical removal occurred. Conclusions: Laparoscopic implantation of the MSA device was safe and well tolerated. It can effectively control the symptoms of gastroesophageal reflux disease, reduce medication, restore normal cardia morphology and function, and esophageal acid exposure. The main postoperative complication was dysphagia, but it was relatively mild.

Robotic Magnetic Sphincter Augmentation Device Removal.

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

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.

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.

Magnetic sphincter augmentation may limit access to magnetic resonance imaging.

Magnetic sphincter augmentation (MSA) is an alternative surgical treatment for gastroesophageal reflux disease; however, >1.5T magnetic resonance imaging (MRI) is contraindicated for patients who have undergone MSA with the LINX Reflux Management System (Torax Medical, Inc. Shoreview, Minnesota, USA). This drawback can impose a barrier to access of MRI, and cases of surgical removal of the device to enable patients to undergo MRI have been reported. To evaluate access to MRI for patients with an MSA device, we conducted a structured telephone interview with all diagnostic imaging providers in Arizona in 2022. In 2022, only 54 of 110 (49.1%) locations that provide MRI services had at least one 1.5T or lower MRI scanner. The rapid replacement of 1.5T MRI scanners by more advanced technology may limit healthcare options and create an access barrier for patients with an MSA device.

Removal of the magnetic sphincter augmentation device: an assessment of etiology, clinical presentation, and management

BackgroundMagnetic sphincter augmentation (MSA) erosion, disruption or displacement clearly requires device removal. However, up to 5.5% of patients without anatomical failure require removal for dysphagia or recurrent GERD symptoms. Studies characterizing these patients or their management are limited. We aimed to characterize these patients, compare their outcomes, and determine the necessity for further reflux surgery.MethodsThis is a retrospective review of 777 patients who underwent MSA at our institution between 2013 and 2021. Patients who underwent device removal for persistent dysphagia or recurrent GERD symptoms were included. Demographic, clinical, objective testing, and quality of life data obtained preoperatively, after implantation and following removal were compared between removal for dysphagia and GERD groups. Sub-analyses were performed comparing outcomes with and without an anti-reflux surgery (ARS) at the time of removal.ResultsA total of 40 (5.1%) patients underwent device removal, 31 (77.5%) for dysphagia and 9 (22.5%) for GERD. After implantation, dysphagia patients had less heartburn (12.9-vs-77.7%, p = 0.0005) less regurgitation (16.1-vs-55.5%, p = 0.0286), and more pH-normalization (91.7-vs-33.3%, p = 0.0158). Removal without ARS was performed in 5 (55.6%) GERD and 22 (71.0%) dysphagia patients. Removal for dysphagia patients had more complete symptom resolution (63.6-vs-0.0%, p = 0.0159), freedom from PPIs (81.8-vs-0.0%, p = 0.0016) and pH-normalization (77.8-vs-0.0%, p = 0.0455).Patients who underwent removal for dysphagia had comparable symptom resolution (p = 0.6770, freedom from PPI (p = 0.3841) and pH-normalization (p = 0.2534) with or without ARS. Those who refused ARS with removal for GERD had more heartburn (100.0%-vs-25.0%, p = 0.0476), regurgitation (80.0%-vs-0.0%, p = 0.0476) and PPI use (75.0%-vs-0.0%, p = 0.0476).ConclusionsMSA removal outcomes are dependent on the indication for removal. Removal for dysphagia yields excellent outcomes regardless of anti-reflux surgery. Patients with persistent GERD had worse outcomes on all measures without ARS. We propose a tailored approach to MSA removal-based indication for removal.Graphical abstract

Real-world evidence with magnetic sphincter augmentation for gastroesophageal reflux disease: a scoping review

Summary Background The burden of gastroesophageal reflux disease (GERD) is high, with up to 30% of the Western population reporting reflux-related symptoms with or without hiatal hernia. Magnetic sphincter augmentation (MSA) is a standardized laparoscopic procedure for patients who are dissatisfied with medical therapy and for those with early-stage disease who would not usually be considered ideal candidates for fundoplication. The MSA device is manufactured in different sizes and is designed to augment the physiologic barrier to reflux by magnetic force. Methods An extensive scoping review was performed to provide a map of current evidence with respect to MSA, to identify gaps in knowledge, and to make recommendations for future research. All the authors contributed to the literature search in PubMed and Web of Science and contributed to summarizing the evidence. Results Magnetic sphincter augmentation, especially in combination with crural repair, is effective in reducing GERD symptoms, proton pump inhibitor use, and esophageal acid exposure, and in improving patients’ quality of life. Safety issues such as device erosion or migration have been rare and not associated with mortality. The MSA device can be removed laparoscopically if necessary, thereby preserving the option of fundoplication or other therapies in the future. Contraindication to scanning in high-power Tesla magnetic resonance systems remains a potential limitation of the MSA procedure. High-resolution manometry and functional lumen imaging probes appear to be promising tools to predict procedural outcomes by improving reflux control and reducing the incidence of dysphagia. Conclusion A consensus on acquisition and interpretation of high-resolution manometry and impedance planimetry data is needed to gain better understanding of physiology, to improve patient selection, and to pave the way for a personalized surgical approach in antireflux surgery.

Is systematic formal crural repair mandatory at the time of magnetic sphincter augmentation implantation?

Laparoscopic placement of the LINX Magnetic Sphincter Augmentation (MSA) device has become an accepted alternative to fundoplication in appropriate patients. Initial studies of MSA targeted to patients with 'early' disease allowed for the most minimal dissection of the esophagus to place the device, without hiatal dissection or repair (NoHHR), in patients with no or minimal hernia findings at surgery. Subsequent studies have compared systematic formal hiatal dissection and repair (Formal HHR) with the original minimal dissection technique. Review of published literature on MSA includes discussion on treatment of hiatal hernia at the time of implantation, accompanying the review of the physiology of the crural diaphragm. Formal hiatal hernia repair at the time of MSA implantation results in better control of reflux with less dysphagia and risk of postoperative hernia than NoHHR, regardless of the presence or size of hiatal hernia. Systematic crural repair should accompany any MSA implantation regardless of the presence or size of hiatal hernia.

Magnetic sphincter augmentation: laparoscopic or robotic approach?

Gastroesophageal reflux disease (GERD)-the pathologic reflux of gastric contents into the distal esophagus-is the most common benign disorder of the esophagus. Its incidence is at 10-20% of the Western population and it yearly cost of treatment in the USA in 9.3 billion dollars. Although first line treatment for the disorder is medical therapy with proton pump inhibitors, an estimated 30-40% of patients will continue to experience medically refractory GERD. In this population anti-reflux surgery can be offered. Traditional anti-reflux surgery is done via the Nissen fundoplication, a technically difficult surgery with uncomfortable side effects of bloating and inability to belch. Magnetic sphincter augmentation (MSA) of the lower esophagus via the LINX device was introduced a less technically challenging alternative to the Nissen. The LINX provides fewer side effects of bloating and inability to belch and has been adapted widely to the practice of anti-reflux surgery. In this paper we discuss the progression of surgical practices with the LINX, including an analysis of the laparoscopic and robotic approaches to MSA device implantation.

OGBN V08 Day case explantation of a magnetic lower oesophagal sphincter augmentation device due to dysphagia

Abstract Background Although laparoscopic Nissen fundoplication remains the gold standard surgical treatment of gastroesophageal reflux disease (GERD), the magnetic Lower oesophageal sphincter augmentation device (LINX ®) has been suggested as a safe alternative for patients with uncomplicated and early-stage disease. The LINX device is a small flexible band of interlinked titanium beads with magnetic cores designed to mimic the body's natural defence mechanism against reflux in patients with GERD. Concerns about the LINX procedure comprise erosions and dysphagia. The purpose of this video is to show a safe technique for the removal of the device and how to check the integrity of the oesophagus. Methods A video presentation explaining the needed investigations before LINX removal and showing a safe technique for removal of LINX device and how to check oesophageal integrity afterwards. Results The LINX device was explanted safely the patient went home afterwards. Conclusions Explantation of t the LINX device can be done safely as a day case with precautions. Take home message is to carefully dissect the capsule around each bead and to use OGD to exclude any oesophageal injury.

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.

Laparoscopic management of pathologic gastroesophageal reflux after sleeve gastrectomy using the magnetic sphincter augmentation (MSA) device—a Video Vignette

PurposeThe development of gastroesophageal reflux disease (GERD) has been shown to be not infrequent after laparoscopic sleeve gastrectomy (LSG). Management may vary from medical therapy to Roux-en-Y gastric bypass (RYGB) conversion. Magnetic sphincter augmentation (MSA) device has been shown to be a promising option with excellent results. The purpose of this video was to demonstrate the laparoscopic management of post-LSG GERD with MSA device implant.Materials and MethodsAn intraoperative video has been edited to demonstrate the MSA device placement after LSG for the treatment of pathologic GERD.ResultsThe procedure started with the lysis of the perigastric adhesions to free the distal esophagus circumferentially. The posterior vagus nerve was identified, and a small window was created between the posterior esophageal wall anteriorly and the vagus nerve posteriorly. A hiatoplasty was performed using two non-resorbable interrupted 2.0 Prolene® sutures. The system’s sizer was placed to measure the junctional circumference. A 15-mm MSA device was implanted.ConclusionMSA device placement seems technically feasible and safe with promising results in term of improved LES resting pressure and esophageal acid exposure. While future studies are necessary to corroborate these preliminary indications, MSA device may possibly become a valid option in surgeon armamentarium.

Impedance planimetry (EndoFLIP™) after magnetic sphincter augmentation (LINX®) compared to fundoplication.

Functional luminal imaging probe (FLIP) use during laparoscopic fundoplication (LF) for gastroesophageal reflux disease is well described. However, there is a lack of data on FLIP measurements during magnetic sphincter augmentation (MSA). This study aims to report our institutional experience in performing FLIP during MSA and to compare these measurements to those obtained during Nissen and Toupet fundoplication. A retrospective review of a prospectively maintained quality database was performed. Patients who underwent MSA or LF and had FLIP measurements between April 2018 and June 2021 were included. FLIP measurements at the gastroesophageal junction (GEJ) were recorded without pneumoperitoneum at 40mL balloon fill after hernia reduction, cruroplasty, and MSA or fundoplication. Reflux symptom index (RSI), GERD-HRQL, and dysphagia score were collected up to 2years. Group comparisons were made using two-tailed Wilcoxon rank-sum and χ2 tests, with statistical significance of p < 0.05. Twenty-seven patients underwent MSA and 100 patients underwent LF (66% Toupet, 34% Nissen). Type III hiatal hernia was present in 3.7% of MSA patients versus over 50% for fundoplication patients. Minimum diameter, cross-sectional area, and distensibility index (DI) were lower after MSA device placement compared to Nissen or Toupet fundoplication (p < 0.05). Postoperative follow-up showed no differences in RSI, GERD-HRQL, and dysphagia score between MSA and Nissen fundoplication (p > 0.05). Intraoperative impedance planimetry provided objective information regarding the geometry of the GEJ during MSA. The ring of magnetic beads restores the anti-reflux barrier and transiently opens with food bolus and belching. The magnetic force of the beads may explain why the DI after MSA is lower yet postoperative quality of life is no different than Nissen fundoplication.

Endoscopic Removal of an Eroded LINX® Device Using a Mechanical Biliary Lithotriptor

Background: Magnetic sphincter augmentation (MSA) via the surgical placement of a LINX® device (LINX® Reflux Management System, Torax Medical, Shoreview, MN, USA) is an increasingly performed minimally invasive outpatient anti-reflux procedure with a low erosion rate. The most common initial approach to eroded LINX® devices is endoscopic removal. Often endoscopy centers do not have specialized devices to cut through the newer, more durable LINX® systems. In this paper we describe a unique approach for removal of a LINX® with intraluminal erosion using a commonly stocked mechanical biliary lithotripsy device. Case description: A 63-year-old male with a history of GERD and symptomatic type III paraesophageal hernia (PEH) underwent a robotic PEH repair with magnetic sphincter augmentation (1.5T, 17 bead) at an outside hospital. He developed an acute recurrence of his PEH, and subsequent upper endoscopy and contrast esophagram four weeks postoperatively revealed a gastric erosion of the LINX device, which had migrated 6 cm onto the stomach. Attempted endoscopic LINX® removal using the OVESCO remove DC Cutter device was unsuccessful. Using principles of prior endoscopic bariatric lap band foreign body removal, the entire LINX® device was successfully removed with the described biliary lithotriptor technique. Conclusion: Using a common biliary mechanical lithotriptor device and a guidewire to transect the newer 1.5T LINX® Reflux Management System is a safe, effective and familiar technique for endoscopic removal of an eroded MSA device.

Complete endoscopic removal of an eroded magnetic sphincter augmentation device.

Video 1Technique for complete endoscopic removal of the eroded and migrated LINX device using the Ovesco DC current retrieval system.

Magnetic sphincter augmentation device removal: surgical technique and results at medium-term follow-up

BackgroundThe magnetic sphincter augmentation (MSA) device has become a common option for the treatment of gastroesophageal reflux disease (GERD). Knowledge of MSA-related complications, indications for removal, and techniques are puzzled. With this study, we aimed to evaluate indications, techniques for removal, surgical approach, and outcomes with MSA removal.MethodsThis is an observational singe-center study. Patients were followed up regularly with endoscopy, pH monitoring, and assessed for specific gastroesophageal reflux disease health-related quality of life (GERD-HRQL) and generic short-form 36 (SF-36) quality of life.ResultsFive patients underwent MSA explant. Four patients were males and the median age was 47 years (range 44–55). Heartburn, epigastric/chest pain, and dysphagia were commonly reported. The median implant duration was 46 months (range 31–72). A laparoscopic approach was adopted in all patients. Intraoperative findings included normal anatomy (40%), herniation in the mediastinum (40%), and erosion (20%). The most common anti-reflux procedures were Dor (n = 2), Toupet (n = 2), and anterior partial fundoplication (n = 1). The median operative time was 145 min (range 60–185), and the median hospital length of stay was 4 days (range 3–6). The median postoperative follow-up was 41 months (range 12–51). At the last follow-up, 80% of patients were off PPI; the GERD-HRQL and SF-36 questionnaire were improved with DeMeester score and esophageal acid exposure normalization.ConclusionThe MSA device can be safely explanted through a single-stage laparoscopic procedure. Tailoring a fundoplication, according to preoperative patient symptoms and intraoperative findings, seems feasible and safe with a promising trend toward improved symptoms and quality of life.

LINX

The LINX device consists of a “bracelet” of magnetic beads in titanium cases, connected by individual wires placed noncompressively around the distal esophagus during laparoscopic surgery. This augments the native lower esophageal sphincter’s (LES) ability to resist reflux by increasing yield pressure and resisting shortening of the LES. Magnetic sphincter augmentation (MSA) was conceived as a safe, stomach sparing, minimally invasive, reversible implantable device for patients seeking an alternative to laparoscopic Nissen fundoplication. Though initially studied in patients with limited hiatal hernias, its use has expanded to include patients with large and even giant or paraesophageal hernias with excellent results. The author’s techniques of complete esophageal dissection, precise hiatal repair, current concepts on noncompressive sizing and placement of the MSA device are reviewed in this article. MSA can be considered first-line surgical therapy for GERD patients with adequate peristalsis regardless of hernia size.

Safety and efficacy of an implantable device for management of gastroesophageal reflux in lung transplant recipients.

BackgroundMagnetic sphincter augmentation (MSA) is a promising minimally invasive surgical technique for management of gastroesophageal reflux disease (GERD); however, device implantation after transplantation has not been studied and may be concerning in these immunosuppressed patients. We explored the safety of the LINX Reflux Management System (MSA device) for management of GERD following lung transplantation (LTx).MethodsLung transplant recipients who underwent LINX implantation at our institution between 2017 and 2019 were followed prospectively in the Reflux Following Lung Transplantation and Associated Treatment Registry. Ambulatory pH testing and acid-suppressing medication use were compared before and after LINX implantation. One-year outcomes and change in pulmonary function were compared between matched LINX and fundoplication groups.ResultsOf 17 patients who underwent post-lung transplant LINX implantation, 8 (47.1%) agreed to undergo post-LINX pH testing. Three/eight (37.5%) patients achieved normal esophageal acid exposure time; 14 (82.4%) remained on acid-suppressing medication at one-year under the direction of their transplant teams. One-year patient survival and change in pulmonary function were similar between groups. LINX patients experienced more early side effects.ConclusionsUse of the LINX MSA device in a cohort of lung transplant recipients at our institution was associated with similar short-term safety compared to traditional fundoplication, however assessment of efficacy was limited. Further investigation is needed to characterize the long-term efficacy of LINX implantation after LTx.

Reference high-resolution manometry values after magnetic sphincter augmentation.

BackgroundMagnetic sphincter augmentation (MSA) is an innovative antireflux procedure that can improve lower esophageal sphincter (LES) competency and reduce symptoms of gastroesophageal reflux disease (GERD). Some patients report postoperative dysphagia. To date, no studies have described reference high‐resolution manometry (HRM) values after MSA implantation.MethodsHigh‐resolution manometry was performed in patients free of dysphagia after MSA with or without concurrent crura repair. Reference values for all parameters of the Chicago Classification were defined as those between the 5th and 95th percentiles. The contribution of concurrent crura repair to LES competency and to reference values was also analyzed.Key ResultsEighty‐four patients met the study inclusion criteria. The upper limit of normality for integrated relaxation pressure (IRP) and intrabolus pressure (IBP) was 20.2 mmHg and 30.3 mmHg, respectively. Both variables were higher after MSA compared to normative Chicago Classification v3.0 values. The Distal Contractile Integral upper limit was in the range of normality. Patients undergoing crura repair had a significantly higher IRP (p = 0.0378) and lower GERDQ‐A scores (p = 0.0374) and Reflux Symptom Index (p = 0.0030) compared to those who underwent MSA device implantation alone.Conclusion & InferencesThis study provides HRM reference values for patients undergoing successful MSA implantation. Crural repair appears to be a key component of LES augmentation and is associated with improved clinical outcomes.

Magnetic sphincter augmentation device placement for treatment of gastroesophageal reflux.

Gastroesophageal reflux disease typically is treated with lifestyle modifications and proton pump inhibitors (PPIs). Surgery is effective in treating the symptoms associated with gastroesophageal reflux, but common procedures involve invasive techniques that can leave the patient unable to belch or vomit. Research has raised concerns regarding the long-term use of PPIs, leaving few treatment options for patients with refractory reflux symptoms. The magnetic sphincter augmentation device demonstrates similar efficacy to existing antireflux procedures, avoids complex surgery techniques, and preserves normal physiologic functions at the lower esophageal sphincter. This device is a safe and effective alternative to more invasive procedures for patients whose GERD does not respond to medical management.