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.

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.

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

BACKGROUND: 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 ≥3 cm. METHODS: 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 ≥3 cm by intraoperative measurement. RESULTS: A total of 192 patients were reviewed. Median follow-up was 20 months (3-75 months). 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 ≥3 cm (range 3-7 cm). 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). CONCLUSION: 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.

Charges, outcomes, and complications: a comparison of magnetic sphincter augmentation versus laparoscopic Nissen fundoplication for the treatment of GERD.

BACKGROUND: Magnetic sphincter augmentation (MSA) is approved for uncomplicated GERD. Multiple studies have shown MSA to compare favorably to laparoscopic Nissen fundoplication (LNF) in terms of symptom control with results out to 5 years. The MSA device itself, however, is an added cost to an anti-reflux surgery, and direct cost comparison studies have not been done between MSA and LNF. The aim of the study was to compare charges, complications, and outcome of MSA versus LNF at 1 year. METHODS: This is a retrospective analysis of all patients who underwent MSA or LNF for the treatment of GERD between January 2010 and June 2013. Patient charges were collected for the surgical admission. We also collected data on 30-day complications and symptom control at 1 year assessed by GERD-HRQL score and PPI use. RESULTS: There were 119 patients included in the study, 52 MSA and 67 LNF. There was no significant difference between the mean charges for MSA and LNF ($48,491 vs. $50,111, p = 0.506). There were significant differences in OR time (66 min MSA vs. 82 min LNF, p < 0.01) and LOS (17 h MSA vs. 38 h LNF, p < 0.01). At 1-year follow-up, mean GERD-HRQL was 4.3 for MSA versus 5.1 for LNF (p = 0.47) and 85 % of MSA patients versus 92 % of LNF patients were free from PPIs (p = 0.37). MSA patients reported less gas bloat symptoms (23 vs. 53 %, p ≤ 0.01) and inability to belch (10 vs. 36 %, p ≤ 0.01) and vomit (4 vs. 19 %, p ≤ 0.01). CONCLUSION: The side effect profile of MSA is better than LNF as evidenced by less gas bloat and increase ability to belch and vomit. LNF and MSA are comparable in symptom control, safety, and overall hospital charges. The charge for the MSA device is offset by less charges in other categories as a result of the shorter operative time and LOS.

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

BACKGROUND: 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. METHODS: A multi-institutional retrospective cohort study of patients with GERD undergoing either MSA or NF. Comparisons were made at 1 year for the overall group and for a propensity-matched group. RESULTS: 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. CONCLUSIONS: 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.

Outcomes following laparoscopic transhiatal esophagectomy for esophageal cancer.

BACKGROUND: Most published minimally invasive esophagectomy techniques involve a multiple field approach, including laparoscopic and thoracoscopic esophageal mobilization. Laparoscopic transhiatal esophagectomy (LTE) should potentially reduce the complications associated with thoracotomy. This study aims to compare outcomes of LTE with open transhiatal esophagectomy (OTE) and en-bloc esophagectomy (EBE). METHODS: Retrospective chart review was performed on all patients who had an LTE for cancer between July 2008 and July 2012 at our institution. Data was compared with an historic cohort of patients who underwent OTE and EBE at the same institution from July 2002 to July 2008. RESULTS: There were 33 patients with LTE, compared with 60 patients with OTE and 139 with EBE. The presence of minor operative complications was similar (p = 0.36), but major complications were significantly less common in the LTE group (12, 23 and 33 %, respectively; p = 0.04). The median number of blood transfusions during hospitalization was significantly lower in the LTE group (0, 2.5 and 3, respectively; p = 0.005). Median tumor size was significantly smaller (1.5, 2.2, and 3 cm, respectively; p = 0.03), but the LTE group had a significantly higher percentage of patients with neoadjuvant treatment (39, 14 and 29 %, respectively; p = 0.008). Median lymph node yield for LTE was lower (24, 36 and 48, respectively; p < 0.0001), but the percentage of patients with positive nodes was similar (33, 33 and 39 %, respectively; p = 0.69). Mortality was equivalent among the groups (0, 2 and 4 %, respectively; p = 0.38). The median LOS for the LTE group was significantly lower (10, 13 and 15 days, respectively; p < 0.0001). Overall survival was not different between the three groups (p = 0.65), with median survival at 24 months of 70, 65 and 65 %, respectively. CONCLUSION: LTE can be performed safely with less major complications and shorter hospital stay than open esophagectomy. The reduced lymph-node harvest did not impact overall survival.

Transgastric large-organ extraction: the initial human experience.

INTRODUCTION: In laparoscopy, it often is the case that port sites are enlarged for specimen extraction. This leads to higher risk of trocar site complications, such as infection or incisional hernia. Natural orifice surgery (NOTES) is beneficial for minimizing these complications, and this is emphasized when the extracted specimen is of large volume. We have been using transgastric technique for appendectomy, cholecystectomy, and laparoscopic sleeve gastrectomy (LSG). Of these transgastric operations, we focus on the one with relatively large-organ extraction: LSG with transoral remnant extraction (TORE). We describe the details and feasibility of this procedure and compare the outcomes to conventional LSG. METHODS: All patients undergoing LSG were considered candidates for TORE and were consented for this procedure if interested after an informed discussion. Eighteen LSGs with TORE (TORE group) and ten conventional LSGs (non-TORE group) were performed from August 2010 to March 2011. We retrospectively compared these two groups for the age, sex, preoperative body mass index, operating room time, hospital stay, excess weight loss (EWL), and trocar site complications. Laparoscopic sleeve gastrectomy with TORE consists of conventional LSG and transgastric retrieval of the resected stomach. The procedure exceeds exactly the same manner as conventional LSG until the initial stapling of the stomach. For TORE, the gastrectomy is initiated 5 cm proximal to the pylorus than usual LSG to save the space for the gastrotomy used for specimen retrieval. After the gastrectomy is completed, the full thickness of the distal most part of the staple line is incised open as wide as 2 cm by using electric cautery or ultrasonic dissector. A flexible upper endoscope, which has been in the stomach already as a bougie for gastrectomy, is then guided into the peritoneal cavity through the gastrotomy. The specimen is grasped endoscopically with a snare and extracted transorally. Following this, the gastrotomy is closed laparoscopically. The final shape of the gastric sleeve is identical to the one of conventional LSG. RESULTS: There was no significant difference between the TORE and the non-TORE group for patients' profile, operating room time, hospital stay, and EWL. Neither group has experienced perioperative complications. All specimens were extracted readily and safely in the TORE group. Of the ten cases in the non-TORE group, four required extension of the trocar site. No trocar site complications were found in the TORE group, whereas the extended trocar site developed panniculitis in two cases of the non-TORE group; one required panniculectomy for refractory induration. CONCLUSIONS: TORE can be safely and easily performed by surgeons with laparoscopic and endoscopic skill, and with commonly available instruments. While producing identical outcomes, our initial experience with the TORE technique demonstrates an advantage over traditional LSG, because it minimizes trocar site complications. Transgastric organ extraction is potentially applicable to other large-organ extractions in laparoscopic surgery without excessive risk or resources. Larger case volume and longer follow-up period is awaited.

Lower Rates of Unplanned Conversion to Open in Robotic Approach to Esophagectomy for Cancer.

BACKGROUND: Minimally invasive approaches to esophagectomy have gained popularity worldwide; however, unplanned conversion to an open approach is not uncommon. This study sought to investigate risk factors associated with converting to an open approach and to evaluate outcomes following conversion. METHODS: Patients undergoing minimally invasive esophagectomy (MIE) for cancer were identified using the 2016-2019 Procedure Targeted NSQIP Database. Multivariable, stepwise logistic regression analysis was performed to investigate factors associated with unplanned conversion to open esophagectomy. Propensity-matched comparison of robotic (RAMIE) to traditional MIE was performed. RESULTS: A total of 1347 patients were included; 140 patients (10%) underwent conversion to open. Morbid obesity, diabetes, hypertension, American Society of Anesthesiologists class, and squamous cell carcinoma were associated with a higher likelihood of conversion. A robotic approach was associated with a lower likelihood of conversion to open (OR .57, 95% CI 0.32-.99). On multivariable analysis, squamous cell carcinoma pathology was the only variable independently associated with higher odds of conversion (OR 2.66, 95% CI 1.02-6.98). Propensity-matched comparison of RAMIE vs MIE showed no significant difference in conversion rate (6.5% vs 9.1%, P = .298), morbidity, or mortality. DISCUSSION: A robotic approach to esophagectomy was associated with a lower likelihood of unplanned conversion to open, and patients who were converted to open experienced worse outcomes. Future studies should aim to determine why a robotic esophagectomy approach may lead to fewer open conversions as it may be an underappreciated benefit of this newest operative approach.

Impact of Robotic Approach on Post-Anastomotic Leaks After Esophagectomy for Esophageal Cancer.

INTRODUCTION: Although mortality rates after esophagectomy have decreased over the last 30 years, anastomotic leaks still commonly persist and portend significant morbidity. Previous studies have analyzed patient and perio-perative risk factors for leaks, yet data describing the association of leaks and an open or minimally invasive approach are lacking. The purpose of this study was to evaluate the impact of operative approach on leak rates and subsequent management of the leaks. METHODS: We queried the Procedure-Targeted National Surgical Quality Improvement Program Database for patients undergoing esophagectomy for cancer in the years from 2016 to 2019. Patient demographics, disease-related information, peri-operative data, and short-term outcomes were reviewed. Multivariable, stepwise logistic regression analysis was performed to investigate factors associated with post-operative anastomotic leaks. RESULTS: Of the 2696 patients who underwent esophagectomy for cancer, anastomotic leaks occurred in 374 (14%). Based on approach, 13% of open, 14% of laparoscopic, and 18% of robotic cases were complicated by leak (P = .123). Multivariable analysis identified the following significant risk factors for leak: diabetes (OR 1.32, P = .047), hypertension (OR 1.32, P = .022), and longer operative time (OR 1.61, P < .001). The percentage of leaks requiring endoscopic or operative intervention was 75% for open, 79% for laparoscopic, and 54% for robotic cases (P = .004). CONCLUSIONS: Anastomotic leaks after esophagectomy for cancer occur frequently regardless of surgical approach. Furthermore, these leaks are managed differently after an open, laparoscopic, or robotic approach. Robotic esophagectomies complicated by anastomotic leak required less invasive management.