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

BACKGROUND: The 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. METHODS: This 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. RESULTS: Five 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. CONCLUSION: The 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.

Safety profile of magnetic sphincter augmentation for gastroesophageal reflux disease.

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

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

PURPOSE: The 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 METHODS: An intraoperative video has been edited to demonstrate the MSA device placement after LSG for the treatment of pathologic GERD. RESULTS: The 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. CONCLUSION: MSA 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.

Magnetic challenge against gastroesophageal reflux.

Almost 15 years have passed since the first paper on the possibility of using magnets to prevent gastro-esophageal reflux (GER) was published and so it is time to assess the results obtained with the first magnetic device available on the market, the Linx magnetic sphincter augmentation (MSA) and to consider what other options are forthcoming. MSA demonstrated an anti-reflux activity similar to that of Nissen fundoplication, considered the "gold standard" surgical treatment for GER disease, and caused less gas-bloating and a better ability to allow vomiting and belching. However, unlike Nissen fundoplication, this magnetic device is burdened by complications, which are roughly similar to those of the non-magnetic anti-reflux Angelchik prosthesis, that, after considerable use in the eighties, was shelved due to these complications. It is interesting to note that some of these complications show the same pathophysiological mechanism in both devices. The upcoming new magnetic devices should avoid these complications, as their anti-reflux magnetic mechanism is completely different. The experiments in animals regarding these new magnetic appliances were examined, remarking their advantages and drawbacks, but the way to apply them in surgical practice is long and difficult, although worthy, as they represent the future of magnetic surgery.

Worldwide Experience with Erosion of the Magnetic Sphincter Augmentation Device.

BACKGROUND: The magnetic sphincter augmentation device continues to become a more common antireflux surgical option with low complication rates. Erosion into the esophagus is an important complication to recognize and is reported to occur at very low incidences (0.1-0.15%). Characterization of this complication remains limited. We aim to describe the worldwide experience with erosion of the magnetic sphincter augmentation device including presentation, techniques for removal, and possible risk factors. MATERIALS AND METHODS: We reviewed data obtained from the device manufacturer Torax Medical, Inc., as well as the Manufacturer and User Facility Device Experience (MAUDE) database. The study period was from February 2007 through July 2017 and included all devices placed worldwide. RESULTS: In total, 9453 devices were placed and there were 29 reported cases of erosions. The median time to presentation of an erosion was 26 months with most occurring between 1 and 4 years after placement. The risk of erosion was 0.3% at 4 years after device implantation. Most patients experienced new-onset dysphagia prompting evaluation. Devices were successfully removed in all patients most commonly via an endoscopic removal of the eroded portion followed by a delayed laparoscopic removal of the remaining beads. At a median follow-up of 58 days post-removal, there were no complications and 24 patients have returned to baseline. Four patients reported ongoing mild dysphagia. CONCLUSIONS: Erosion of the LINX device is an important but rare complication to recognize that has been safely managed via minimally invasive approaches without long-term consequences.

Esophageal Penetration of the Magnetic Sphincter Augmentation Device: History Repeats Itself.

BACKGROUND: An alternative approach to the treatment of gastroesophageal reflux disease (GERD) has recently been introduced in clinical practice, involving the implantation of a magnetic sphincter augmentation device (MSAD). This "magnetic ring" is implanted laparoscopically around the lower esophageal sphincter to improve its barrier function. The literature is still limited on the midterm results achieved in controlling reflux because the MSAD is a very new procedure. So far, only a few cases of the MSAD causing erosion of the esophagus have been reported. METHODS: We report on two cases of progressive and severe dysphagia after the implantation of an MSAD elsewhere. In both cases, the symptoms were caused by the migration of the device into the esophagus. RESULTS: The devices were removed endoscopically in a single step in both cases, using the Olympus cutter. After 3 months, the first patient had a laparoscopic Nissen fundoplication without any complications and with a good final reflux control. The second only underwent removal of the device, using the same endoscopic approach and again without any complications. CONCLUSIONS: Judging from the literature, MSAD implantation may be an effective way to control GERD, but the method can carry major complications, such as migration of the device into the esophagus (as in the two cases reported here). Endoscopic removal of a device possibly penetrating inside the esophagus is feasible and safe, and may later be followed up with a laparoscopic antireflux procedure without any particular difficulty.