Short term safety of magnetic sphincter augmentation vs minimally invasive fundoplication: an ACS-NSQIP analysis.

PURPOSE: Magnetic 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 METHODS: The 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. RESULTS: A 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). CONCLUSION: In 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.

The Impact of Ineffective Esophageal Motility on Patients Undergoing Magnetic Sphincter Augmentation.

OBJECTIVE: To evaluate and characterize outcomes of MSA in patients with IEM. SUMMARY BACKGROUND DATA: MSA improves patients with gastroesophageal reflux and normal motility. However, many patients have IEM, which could impact the outcomes of MSA and discourage use. METHODS: An international, multi-institutional case control study of IEM patients undergoing MSA matched to normal patients was performed. Primary outcomes were new onset dysphagia and need for postoperative interventions. RESULTS: A total of 105 IEM patients underwent MSA with matching controls. At 1 year after MSA: GERD-Health Related Quality of Life was similar; DeMeester scores in IEM patients improved to 15.7 and 8.5 in controls ( P = 0.021); and normalization of the DeMeester score for IEM = 61.7% and controls = 73.1% ( P = 0.079).In IEM patients, 10/12 (83%) with preop dysphagia had resolution; 11/66 (17%) had new onset dysphagia and 55/66 (83%) never had dysphagia. Comparatively, in non-IEM patients, 22/24 (92%) had dysphagia resolve; 2/24 (8%) had persistent dysphagia; 7/69 (10%) had new onset dysphagia, and 62/69 (90%) never had dysphagia.Overall, 19 (18%) IEM patients were dilated after MSA, whereas 12 (11%) non-IEM patients underwent dilation ( P = 0.151). Nine (9%) patients in both groups had their device explanted. CONCLUSIONS: Patients with IEM undergoing MSA demonstrate improved quality of life and reduction in acid exposure. Key differences in IEM patients include lower rates of objective GERD resolution, lower resolution of existing dysphagia, higher rates of new onset dysphagia and need for dilation. GERD patients with IEM should be counselled about these possibilities.

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.

Gastric electric stimulator versus gastrectomy for the treatment of medically refractory gastroparesis.

BACKGROUND: Gastric electrical stimulation (GES) and laparoscopic gastrectomy (LG) are known therapeutic options for medically refractory gastroparesis (MRG) although there are limited data comparing their outcomes. We aim to compare clinical outcomes between patients undergoing GES vs upfront LG for the treatment of MRG while examining factors associated with GES failure and conversion to LG. METHODS: We retrospectively analyzed 181 consecutive patients who underwent GES or LG for MRG at our institution from January 2003 to December 2017. Data collection consisted of chart review and follow-up telephone survey. Statistical analysis utilized Chi-squared, ANOVA, and multivariable logistic regression. RESULTS: Overall, 130 (72%) patients underwent GES and 51 (28%) LG as primary intervention. GES patients were more likely to have diabetic gastroparesis (GES 67% vs LG 39%, p < 0.001), while primary LG patients were more likely to have post-surgical gastroparesis (GES 5% vs LG 43%, p < 0.001). Postoperatively, primary LG patients had higher rates of major in-hospital morbidity events (GES 5% vs LG 18%, p = 0.017) and longer hospital stays (GES 3 vs LG 9 days, p < 0.001). However, over a mean 35-month follow-up period, there were no differences in the rates of major morbidity, readmissions, or mortality. Multivariable regression analysis revealed patients undergoing GES as a primary intervention were less likely to report improvement in symptoms on follow-up compared to primary LG patients OR 0.160 (95% CI 0.048-0.532). Additionally, patients who converted to LG from GES were more likely to have post-surgical gastroparesis as the primary etiology. CONCLUSION: GES as a first-line surgical treatment of MRG was associated with worse outcomes compared to LG. Post-surgical etiology was associated with an increased likelihood of GES failure, and in such patients, upfront gastrectomy may be a superior alternative to GES. Further studies are needed to determine patient selection for operative treatment of MRG.

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

BACKGROUND: 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. METHODS: 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. RESULTS: 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 15.4 months. 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. CONCLUSIONS: 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.

Understanding the GERD Barrier.

Gastroesophageal reflux disease (GERD) is steadily increasing in incidence and now affects 18% to 28% of the population in the United States. A thorough understanding of the pathophysiology underlying this disease is necessary to improve the current standard of care. Most GERD pathophysiology models focus on the lower esophageal sphincter (LES) as the key element which prevents esophageal reflux. More recent research has highlighted the crural diaphragm (CD) as an additional critical component of the GERD barrier. We now know that the CD actively relaxes when the distal esophagus is distended and contracts when the stomach is distended. Crural myotomy in animal models increases esophageal acid exposure, highlighting the CD's vital role. There are also multiple physiological studies in patients with symptomatic hiatal hernia that demonstrate CD dysfunction is associated with GERD. Finally, computer models integrating physiological data predict that the CD and the LES each contribute roughly 50% to the GERD barrier. This more robust understanding has implications for future procedural management of GERD. Specifically, effective GERD management mandates repair of the CD and reinforcement of the LES. Given the high rate of hiatal hernia recurrences, it seems that novel antireflux procedures should target this essential component of the GERD barrier. Future research should focus on methods to maintain crural integrity, decrease hiatal hernia recurrence, and improve long-term competency of the GERD barrier.

Less is more: cruroplasty alone is sufficient for revisional hiatal hernia surgery.

BACKGROUND: Recurrence of hiatal hernia after anti-reflux surgery is common, with past studies reporting recurrence rates of 10-15%. Most patients experience relief from GERD symptoms following initial repair; however, those suffering from recurrence can have symptoms severe enough to warrant another operation. Although the standard of care is to revise the fundoplication or convert to magnetic sphincter augmentation (MSA) in addition to redo cruroplasty, it stands to reason that with an intact fundoplication, a repeat cruroplasty is all that is necessary to alleviate the patients' symptoms. In other words, only fix that which is broken. METHODS: A retrospective review of patients with symptomatic hiatal hernia recurrence who underwent reoperation between January 2011 and September 2018 was conducted. Patients who received revisional cruroplasty alone were compared with cruroplasty plus some other revision (fundoplication revision, or takedown and MSA placement). Demographics, operative details, and postoperative outcomes were collected. RESULTS: There were 73 patients identified. Median time to recurrence after the first procedure was 3.7 (1.9-8.2) years. Thirty-two percent of the patients had GERD symptoms for more than 10 years. Twenty-six patients underwent cruroplasty only. Forty-seven patients underwent cruroplasty plus fundoplication revision. There were no significant differences in operative times (2.4 h cruroplasty alone, 2.8 h full revision, p = 0.75) or postoperative complications between the two groups. Patients had a mean follow-up time of 1.64 years. Of the 73 patients, 8 had subsequent hiatal hernia recurrence. The recurrence rate for patients with cruroplasty alone was 11%, and the recurrence rate for the full revision group was 12% (p = 1.00). CONCLUSION: Leaving an intact fundoplication alone at the time of revisional surgery did not adversely affect surgical outcomes. This data suggests a role for hernia-only repair for recurrent hiatal hernias.

Regression of Barrett's esophagus after magnetic sphincter augmentation: intermediate-term results.

BACKGROUND: Untreated gastroesophageal reflux disease (GERD) can lead to Barrett's esophagus and an increased risk for esophageal adenocarcinoma. Magnetic sphincter augmentation (MSA) is a safe and effective modality for the treatment of GERD. Preliminary research on short-term outcomes after MSA demonstrated significant regression of Barrett's. Further investigation is required to evaluate the long-term effect of this treatment. METHODS: A retrospective review of patients was conducted with biopsy-proven Barrett's esophagus who underwent MSA between 2007 and 2019. As a part of their preoperative evaluation, patients underwent esophagogastroduodenoscopy (EGD) with biopsies of the distal esophagus and gastroesophageal junction including any abnormal-appearing segments, pH testing, and a videoesophagram. Patients were categorized according to the length of Barrett's identified (ultrashort < 1 cm, short 1-3 cm, long > 3 cm). Improvement was defined as a decrease in length (e.g. long to short). RESULTS: There were 87 patients identified for study inclusion. 55 patients were male. The median body mass index was 26.95. The median age was 61.81 (49.79-68.29). Mean follow-up time was 2.35 ± (1.57) years. 7 (8.0%) of these patients began with long segment Barrett's, 58 (66.7%) began with short segment disease, and 22 (25.3%) began with an ultrashort segment. Within this cohort, 74 (85.06%) had undergone postoperative biopsy. 7 out of 74 patients (9.46%) showed improvement in their intestinal metaplasia and 45/74 (60.81%) showed complete regression. Fisher's exact test showed a significant decrease in Barrett's length following MSA (p = 0.002). No patients progressed to dysplasia or neoplasia. There was a statistically significant decrease in the median Demeester score from 34.00 to 13.70 after surgery (p < .001). CONCLUSION: MSA reduces esophageal acid exposure and can lead to reduction or resolution of Barrett's esophagus. MSA is also effective at preventing progression of metaplasia to dysplasia or neoplasia. This effect remains consistent even after 2 years of follow-up.

Magnetic sphincter augmentation with hiatal hernia repair: long term outcomes.

INTRODUCTION: Magnetic sphincter augmentation (MSA) is a safe and effective treatment for patients with gastroesophageal reflux disease (GERD). MSA was initially indicated for patients with GERD and concomitant hiatal hernias < 3 cm. However, excellent short- and intermediate-term outcomes following MSA and hiatal hernia repair in patients with hiatal hernias ≥ 3 cm have been reported. The purpose of this study is to assess long-term outcomes for this patient population. METHODS AND PROCEDURES: A retrospective review was performed of patients with GERD and hiatal hernias ≥ 3 cm who underwent MSA and hiatal hernia repair. Patients were treated at two tertiary medical centers between May 2009 and December 2016. Follow up included annual video esophagram, upper endoscopy, or both. Outcomes included pre- and post-operative GERD health-related quality of life (GERD-HRQL) scores, length and regression of Barrett's esophagus, resolution of esophagitis, need for endoscopic dilations or implant removal, and clinically significant hiatal hernia recurrence (> 2 cm) on videoesophagram or endoscopy. RESULTS: Seventy-nine patients (53% female) with a median age of 65.56 (58.42-69.80) years were included. Median follow up was 2.98 (interquartile range 1.90-3.32) years. Median DeMeester scores decreased from 42.45 (29.12-60.73) to 9.10 (3.05-24.30) (p < 0.001). Severity of esophagitis (e.g. LA class C to class B) significantly improved (p < 0.01). Forty percent of patients with Barrett's esophagus experienced regression (p < 0.01). Median GERD-HRQL scores improved from 21 to 2. Five (6.3%) hiatal hernia recurrences occurred, and 1 required re-operation. Age, body mass index, size of the initial hiatal hernia, and sex had no significant effect on whether a patient developed a recurrence. CONCLUSIONS: Magnetic sphincter augmentation in conjunction with large hiatal hernia repairs for patients with GERD achieves excellent long-term radiographic and clinical results, and a low overall need for reoperation, without the need for mesh.

Safety and efficacy of magnetic sphincter augmentation dilation.

BACKGROUND: The magnetic sphincter augmentation device (MSA) provides effective relief of gastroesophageal reflux symptoms. Dysphagia after MSA implantation sometimes prompts endoscopic dilation. The manufacturer's instructions are that it be performed 6 or more weeks after implantation under fluoroscopic guidance to not more than 15 mm keeping 3 or more beads closed. The purpose of this study was to assess adherence to these recommendations and explore the techniques used and outcomes after MSA dilation. METHODS AND PROCEDURES: We conducted a multicenter retrospective review of patients undergoing dilation for dysphagia after MSA placement from 2012 to 2018. RESULTS: A total of 144 patients underwent 245 dilations. The median size of MSA placed was 14 beads (range 12-17) and the median time to dilation was 175 days. A second dilation was performed in 67 patients, 22 patients had a third dilation and 7 patients underwent 4 or more dilations. In total, 17 devices (11.8%) were eventually explanted. The majority of dilations were performed with a balloon dilator (81%). The median dilator size was 18 mm and 73.4% were done with a dilator larger than 15 mm. There was no association between dilator size and need for subsequent dilation. Fluoroscopy was used in 28% of cases. There were no perforations or device erosions related to dilation. DISCUSSION: There is no clinical credence to the manufacturer's recommendation for the use of fluoroscopy and limitation to 15 mm when dilating a patient for dysphagia after MSA implantation. Use of a larger size dilator was not associated with perforation or device erosion, but also did not reduce the need for repeat dilation. Given this, we would recommend that the initial dilation for any size MSA device be done using a 15 mm through-the-scope balloon dilator. Dysphagia prompting dilation after MSA implantation is associated with nearly a 12% risk of device explantation.

Magnetic sphincter augmentation versus fundoplication for gastroesophageal reflux disease: pros and cons.

PURPOSE OF REVIEW: The purpose of this magnetic sphincter augmentation (MSA) year in review article is to provide a clear understanding for the current state of MSA literature in 2019, and contrast MSA outcomes with traditional fundoplication. RECENT FINDINGS: Continued work was performed in 2019 to expand patient populations eligible for MSA including those with hiatal hernia, post-bariatric patients, patients necessitating a thoracic approach, and patients with esophageal intestinal metaplasia. Additionally, a large systematic review reinforced earlier findings comparing laparoscopic fundoplication to MSA. This study demonstrated equivalency over many different operative outcomes, with MSA patients having less bloating while also retaining the ability to belch and vomit. Furthermore, independent research teams found a modest cost savings for MSA over laparoscopic fundoplication with budget analysis. SUMMARY: MSA is a safe and efficacious procedure originally approved for patients with medically refractory, uncomplicated gastroesophageal reflux disease. The accumulating body of evidence suggests patients with intestinal metaplasia or hiatal hernias can safely and effectively undergo MSA, whereas further research will be required before MSA is widely used for post-bariatric patients or for patients requiring a transthoracic surgical approach. MSA is equivalent or superior to laparoscopic fundoplication in all surgical outcomes measured thus far.

Surgical and endoscopic management options for patients with GERD based on proton pump inhibitor symptom response: recommendations from an expert U.S. panel.

BACKGROUND AND AIMS: The objective of this study was to examine expert opinion and agreement on the treatment of distinct GERD profiles from surgical and therapeutic endoscopy perspectives. METHODS: We used the RAND/University of California, Los Angeles Appropriateness Method over 6 months (July 2018 to January 2019) to assess the appropriateness of antireflux interventions among foregut surgeons and therapeutic gastroenterologists. Patients with primary atypical or extraesophageal symptoms were not considered. Patient scenarios were grouped according to their symptom response to proton pump inhibitor (PPI) therapy. The primary outcome was appropriateness of an intervention. RESULTS: Antireflux surgery with laparoscopic fundoplication (LF) and magnetic sphincter augmentation (MSA) were ranked as appropriate for all complete and partial PPI responder scenarios. Transoral incisionless fundoplication was ranked as appropriate in complete and partial PPI responders without a hiatal hernia. Radiofrequency energy was not ranked as appropriate for complete or partial responders. There was lack of agreement between surgery and interventional gastroenterology groups on the appropriateness of LF and MSA for PPI nonresponders. Rankings for PPI nonresponders were similar when results from impedance-pH testing on PPI therapy were available, except that LF and MSA were not ranked as appropriate for PPI nonresponders if the impedance-pH study was negative. CONCLUSIONS: This work highlights areas of agreement for invasive therapeutic approaches for GERD and provides impetus for further interdisciplinary collaboration and trials to compare and generate novel and effective treatment approaches and care pathways, including the role of impedance-pH testing in PPI nonresponders.

Clinical outcome after laparoscopic Nissen fundoplication in patients with GERD and PPI refractory heartburn.

Typical reflux symptoms that respond well to proton pump inhibitor (PPI) therapy are key factors predictive of an excellent outcome with antireflux surgery for gastroesophageal reflux disease (GERD). Our aim was to evaluate whether poor preoperative heartburn (HB) relief with PPIs was associated with a worse outcome after Nissen fundoplication. Patients with a main symptom of HB and a positive pH-test who had a laparoscopic Nissen fundoplication between January 2008 and December 2014 were included. Prior to surgery, patients graded how effectively their HB symptoms were relieved by PPIs. Three groups were defined: good response (76-100% relief), partial response (26-75% relief) and poor response (0-25% relief). Outcomes and satisfaction were assessed at a minimum of 1 year after fundoplication. There were 129 patients who met inclusion criteria and 75 agreed to participate. The median follow-up was 48 months. Prior to Nissen fundoplication 13 patients had a good HB response to PPI-therapy, 36 had a partial response and 26 had a poor response. All patients were satisfied with their HB relief after fundoplication (mean satisfaction score: 9.5/10) and there was no difference in satisfaction score or heartburn relief between groups. Heartburn symptoms that respond poorly to PPI therapy are reliably relieved with a Nissen fundoplication in patients with objectively confirmed GERD. Patient satisfaction after Nissen fundoplication was excellent and was similar in patients with poor versus excellent HB relief with preoperative PPI therapy. Therefore, antireflux surgery is an option for patients with HB and confirmed GERD regardless of the degree of relief of HB symptoms provided by PPI medications.

Objective Evidence of Reflux Control After Magnetic Sphincter Augmentation: One Year Results From a Post Approval Study.

OBJECTIVE: To report 1-year results from a 5-year mandated study. SUMMARY BACKGROUND DATA: In 2012, the United States Food and Drug Administration approved magnetic sphincter augmentation (MSA) with the LINX Reflux Management System (Torax Medical, Shoreview, MN), a novel device for the surgical treatment of gastroesophageal reflux disease (GERD). Continued assessment of safety and effectiveness has been monitored in a Post Approval Study. METHODS: Multicenter, prospective study of patients with pathologic acid reflux confirmed by esophageal pH testing undergoing MSA. Predefined clinical outcomes were assessed at the annual visit including a validated, disease-specific questionnaire, esophagogastricduodenoscopy and esophageal pH monitoring, and use of proton pump inhibitors. RESULTS: A total of 200 patients (102 males, 98 females) with a mean age of 48.5 years (range 19.7-71.6) were treated with MSA between March 2013 and August 2015. At 1 year, the mean total acid exposure time decreased from 10.0% at baseline to 3.6%, and 74.4% of patients had normal esophageal acid exposure time (% time pH<4 ≤5.3%). GERD Health-Related Quality of Life scores improved from a median score of 26.0 at baseline to 4.0 at 1 year, with 84% of patients meeting the predefined success criteria of at least a 50% reduction in total GERD Health-Related Quality of Life score compared with baseline. The device removal rate at 1 year was 2.5%. One erosion and no serious adverse events were reported. CONCLUSIONS: Safety and effectiveness of magnetic sphincter augmentation has been demonstrated outside of an investigational setting to further confirm MSA as treatment for GERD.

Minimal versus obligatory dissection of the diaphragmatic hiatus during magnetic sphincter augmentation surgery.

BACKGROUND: The magnetic sphincter augmentation (MSA) device was initially implanted with minimal hiatal dissection (MHD) at the diaphragmatic hiatus. Due to concern of possible MSA device dysfunction if herniated into an occult or small hiatal hernia, and increased understanding to the role of defective crura in reflux disease, the operative procedure was changed to planned obligatory dissection (OD) of the hiatus at the time of all implantations. METHODS: Between December 2012 and September 2016, 182 patients underwent MSA implant at a single medical center and have complete records available for review through September 2017. The MHD dissection period extended from December 2012 to September 2015, from September 2015 to 2016 all patients underwent OD. RESULTS: MHD occurred 53% (96/182) versus OD in 47% (86/182), mean follow-up time in days for MHD and OD was 554 (SD 427) versus 374 (298) days. Intraoperative measurement of hernia size for the MHD versus OD was 0.77 (1.1) versus 3.95 (2.4) cm, p < 0.001. At first visit follow-up, there was no difference in any dysphagia (p = 0.11). Recurrent GERD (defined as resumption of PPI after successful initial post-operative wean) was less frequent after OD than after MHD, 3.6 versus 16.3%, p = 0.006. Delayed onset dysphagia was 1.2% in the OD group versus 8.6% in the MHD group, p = 0.04. Recurrent hiatal hernia of 2 cm or greater occurred in 0.0% of the OD and 11.5% of the MHD, p = 0.03. Repeat surgery for hiatal hernia repair has occurred in 0% of the OD and 6.6% of the MHD, p = 0.02. CONCLUSION: OD of the hiatus with crural closure resulted in less recurrence of reflux symptoms and hiatal hernia, despite an increased proportion of patients with larger hiatal hernia and more complex anatomic disease at the time of operation.

Removing the magnetic sphincter augmentation device: operative management and outcomes.

BACKGROUND: Recurrent or persistent symptoms of reflux, dysphagia, or device erosion can lead to removal of the magnetic sphincter augmentation (MSA aka Linx) device. Device removal has been previously reported, and outcomes of various surgical management strategies at the time of removal have not been well described. METHODS: This is a retrospective review of patients undergoing MSA removal from March 2009 to September 2017 in a single institution. Reason for removal, operative management, and short-term outcomes are reported. RESULTS: During the study, 435 MSA devices were implanted, 24 of which required removal (5.5%). Removal was due to refractory dysphagia in 1.8% (8/435), for recurrent or persistent GERD in 2.9% (13/435), and secondary to erosion in 0.5% (2/435). Mean time from implant to removal was 863 days (range 119-1762 days). The most common reasons for removal were recurrent GERD (54%), dysphagia (38%), or erosion (8%). Significant operative findings included recurrent or progressive hiatal hernia (38%), erosion (8%), and normal anatomy (46%). Hiatal hernia was found and repaired at the time of device removal in 38% of patients (9/24). The MSA device was removed through laparotomy (4%), laparoscopically (88%), or through a combination of endoscopy and laparoscopy (8%). After removal patients underwent repeat MSA (33%), fundoplication (21%), gastrectomy (4%), or no additional procedure (42%). Symptoms prompting removal of the MSA device had resolved in 52% of patients and improved in an additional 35% at last contact. Of the 10 patients having no anti-reflux procedure after removal, 9 were available for follow-up at a mean of 97 (106) days of whom 22.2% (2/9) had symptoms of GERD or required any anti-reflux medication. No major complications occurred after removal. CONCLUSION: MSA removal when necessary can be accomplished through minimally invasive means. Repeat Linx or fundoplication can be performed after removal, however may not be necessary in patients with removal for dysphagia.

Routine esophageal manometry is not useful in patients with normal videoesophagram.

BACKGROUND: Videoesophagram (VEG) and esophageal manometry (EM) are components of the preoperative evaluation for foregut surgery. EM is able to identify motility disorders and diminished contractility that may alter surgical planning. However, there are no clearly defined criteria to guide this. Reliable manometry is not always easily obtained, and therefore its necessity in routine preoperative evaluation is unclear. We hypothesized that if a patient has normal videoesophagram, manometry does not reveal clinically significant esophageal dysfunction. METHODS: We reviewed patients who underwent protocolized videoesophagram and manometry at our institution. Measures of esophageal motility including the mean distal contractile integral (DCI), mean wave amplitude (MWA), and percent of peristaltic swallows (PPS) were analyzed. The Chicago Classification was used for diagnostic criteria of motility disorders. Normal VEG was defined as stasis of liquid barium on less than three of five swallows. RESULTS: There were 418 patients included. 231 patients (55%) had a normal VEG, and 187 patients (45%) had an abnormal VEG. In the normal VEG group, only 2/231 (0.9%) patients had both abnormal DCI and PPS, 1/231 (0.4%) patients had both abnormal DCI and MWA and no patients had both abnormal MWA and PPS. There were no patients with achalasia or absent contractility and 1 patient with ineffective esophageal motility (IEM) in the normal VEG group. This was significantly different from the abnormal VEG group which included 4 patients with achalasia, 1 with absent contractility and 22 with IEM (p < 0.0001). The negative predictive value of VEG was 99.6% and the sensitivity was 96.4%. CONCLUSIONS: A normal videoesophagram reliably excluded the presence of clinically significant esophageal dysmotility that would alter surgical planning. Routine manometry is not warranted in patients with normal videoesophagram, and should be reserved for patients with abnormal VEG.

Regression of intestinal metaplasia following magnetic sphincter augmentation device placement.

BACKGROUND: Intestinal metaplasia represents an esophageal mucosal transformation due to uncontrolled gastroesophageal reflux disease. Fundoplication has been shown to lead to regression of disease. Magnetic sphincter augmentation is an alternative to fundoplication that effectively treats reflux disease. Initially, patients with intestinal metaplasia were not considered candidates for device placement, so outcomes in these patients are unknown. METHODS: A retrospective review of all patients who underwent magnetic sphincter augmentation device placement between 2007 and 2017 was performed. All patients underwent pre-operative endoscopic evaluation and were categorized as having ultra-short segment (less than 1 cm), short-segment (1-3 cm), or long-segment (greater than or equal to 3 cm) disease. To be included in the study, pathologic examination demonstrating columnar mucosa with goblet cells was required. RESULTS: There were 86 patients with biopsy-proven non-dysplastic intestinal metaplasia. 35 patients had ultra-short segment, 37 patients had short-segment, and 14 patients had long-segment disease. At a median follow-up of 1.2 years, 67/86 (78%) patients completed endoscopic follow-up. 48/67 (71.6%) patients had regression of intestinal metaplasia. There was no progression to dysplasia or carcinoma. Patients with abnormal post-operative DeMeester scores were less likely to have regression of disease. Regression was more likely in the ultra-short segment (82.8%) and short-segment (73.3%) groups compared to the long-segment group (25.0%). CONCLUSIONS: Magnetic sphincter augmentation is effective in achieving regression of intestinal metaplasia. Longer-term follow-up is needed to assess durability of effect and make meaningful comparisons to fundoplication.

Hiatal hernia recurrence following magnetic sphincter augmentation and posterior cruroplasty: intermediate-term outcomes.

BACKGROUND: We have previously reported short-term outcomes after hiatal hernia repair (HHR) at the time of magnetic sphincter augmentation (MSA) for gastroesophageal reflux disease (GERD). Here we report intermediate-term outcomes and hernia recurrence rate after concomitant MSA and HHR. METHODS: This is a retrospective cohort study of patients who underwent repair of a hiatal hernia 3 cm or larger at the time of MSA implantation between May 2009 and December 2015. The primary endpoint was hiatal hernia recurrence identified by routine postoperative videoesophagography or endoscopy. Recurrence was defined by a 2 cm or greater upward displacement of the stomach through the diaphragmatic esophageal hiatus. Secondary endpoints included cessation of proton-pump inhibitor (PPI), persistent dysphagia requiring intervention, and GERD health-related quality-of-life (HRQL) scores 1 year from surgery. RESULTS: During the study period, 47 of 53 (89%) patients underwent concomitant MSA with HHR and complied with surveillance. Hiatal hernias ranged from 3 to 7 cm (mean 4 ± 1). Mean clinical follow-up time was 19 months (range 1-39). GERD-HRQL score decreased from 20.3 to 3.1 (p < .001), 89% of patients remained off PPIs, and 97% of patients reported improvement or resolution of symptoms. Two recurrent hiatal hernias were identified on surveillance imaging for a recurrence rate of 4.3% at a mean 18 (± 10) months after initial operation. Persistent dysphagia occurred in 13% (6/47) over the first year, which resolved after a single balloon dilation in 67% (4/6). Two patients elected for device removal due to dilation-refractory dysphagia and persistent reflux symptoms. CONCLUSION: Concomitant magnetic sphincter augmentation and hiatal hernia repair in patients with gastroesophageal reflux disease and a moderate-sized hiatal hernia demonstrates durable subjective reflux control and an acceptable hiatal hernia recurrence rate at 1- to 2-year follow-up.

Gastric cancer in the young: An advanced disease with poor prognostic features.

BACKGROUND AND OBJECTIVES: Gastric cancer in young patients is rare. We analyzed the clinicopathological features and prognosis of early-onset gastric carcinoma. METHODS: We retrospectively reviewed patients with gastric adenocarcinoma aged ≤45 years and >45 years at our institution over a 17-year period. Clinicopathological features were compared and survival analysis was performed using Kaplan-Meier curves. RESULTS: A total of 121 patients with gastric carcinoma aged ≤45 years were identified. The young group (YG) had a higher incidence of stage III/IV disease (86.8% vs. 57.9%, P < 0.001), poorly-differentiated carcinoma (95.9% vs. 74.4%, P < 0.001), and signet-cell type tumor (88.4% vs. 32.2%, P < 0.001) relative to the older group (OG). The majority of tumors were in the middle third of the stomach in both groups (P = 0.108). Three-year survival in the YG was 87.1%, 32.2%, and 6.9% in stage I/II, III, and IV disease, respectively. Surgical intervention in young patients with advanced carcinoma was not associated with improved survival. Although median survival was shorter in the YG compared to the OG (11.7 vs. 41.0 months, P < 0.001), stage-specific survival was similar. CONCLUSION: Early-onset gastric cancer demonstrates advanced stage of disease, and a high incidence of poorly-differentiated and signet-cell type carcinoma. Overall survival is poor with no added benefit to surgical intervention in advanced disease.