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.

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.

Co-design with aboriginal and torres strait islander communities: A journey.

AIM: This paper explores the principles of co-design with Aboriginal and Torres Strait Islander communities by reflecting on the literature, learning from experiences of allied health professionals, and considering how co-design can be applied in rural and remote allied health practice. CONTEXT: This paper has been authored by a working group from Services for Rural and Remote Allied Health (SARRAH). SARRAH is a member-based allied health organisation, working to improve health outcomes for rural and remote Australians. SARRAH has been representing and supporting allied health professionals in rural and remote Australia for over 20 years, with a member base that includes students, practitioners, programme managers, policy makers and academics. As a non-Indigenous organisation, SARRAH works in partnership and receives guidance from the peak organisation, Indigenous Allied Health Australia (IAHA). APPROACH: Over a period of 3 months, a group of eleven SARRAH members and staff came together to review available literature, seek member perspectives and share their experiences and understandings of co-design. Working group discussions were grounded in the knowledge and experiences shared by two Aboriginal and Torres Strait Islander group members. CONCLUSION: This paper proposes that successful co-design with Aboriginal and Torres Strait Islander communities places legitimate value on different knowledge systems, is built on strong and trusting relationships, promotes inclusive involvement and requires authentic partnerships. Using these principles, SARRAH will engage with members and stakeholders to influence meaningful change in allied health practice in rural and remote Australia.

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.

Sleeve Gastrectomy as a Novel Procedure for Gastroparesis.

BACKGROUND: Laparoscopic sleeve gastrectomy (LSG) has recently been considered for the surgical management of refractory gastroparesis. Our study aims to determine the efficacy of LSG as a new treatment modality for gastroparesis. METHODS: A multi-surgeon single institution retrospective chart review of patients who underwent LSG for refractory gastroparesis from September 2016-December 2017. Pre- and postoperative Patient Assessment of Upper Gastrointestinal Disorders-Symptoms Severity Index and/or Gastroparesis Cardinal Symptom Index (GCSI) questionnaires were reviewed. A telephone survey was conducted. Statistical analysis consisted of two-sample t test and utilized SAS v9.4. A P-value <.05 was considered significant. RESULTS: There were 10 patients included and 80% were women with an average age of 43 years (24-63). Mean Body Mass Index was 24.5 (16.8-39.6), and median gastric emptying at 4 hours was 50% (30-85). Etiology of gastroparesis was 50% idiopathic, 40% diabetic, and 10% postsurgical. 80% of patients had previously undergone gastric electrical stimulator implantation, 20% pyloric botox injections, and 1 patient jejunostomy tube placement. One patient required conversion from laparoscopic to open secondary to adhesions. Median length of stay was 5 days (2-13), and median follow-up was 13.3 months. 90% of patients were tolerating a regular diet at longest follow-up with significant improvement in self-reported symptoms. GCSI scores were 33.6 preoperatively and 14.9 postoperatively (P = .01). DISCUSSION: Our study adds to the literature examining the role of LSG in the treatment of gastroparesis. LSG has favorable outcomes at short-term follow-up for patients with refractory gastroparesis.

Safety and efficacy of robotic-assisted groin hernia repair.

Robotic surgical technology has grown in popularity and applicability, since its conception with emerging uses in general surgery. The robot's contribution of increased stability and dexterity may be beneficial in technically challenging surgeries, namely, inguinal hernia repair. The aim of this project is to contribute to the growing body of literature on robotic technology for inguinal hernia repair (RIHR) by sharing our experience with RIHR at a large, academic institution. We performed a retrospective chart review spanning from March 2015 to April 2018 on all patients who had undergone RIHR at our university hospital. Extracted data include preoperative demographics, operative features, and postoperative outcomes. Data were analyzed with particular focus on complications, including hernia recurrence. A total of 43 patients were included, 40 of which were male. Mean patient age was 56 (range 18-85 years) and mean patient BMI was 26.4 (range 17.5-42.3). Bilateral hernias were diagnosed in 13 patients. All of the patients received transabdominal approaches, and all but one received placement of synthetic polypropylene mesh. There was variety in mesh placement with 23 patients receiving suture fixation and 14 receiving tack fixation. Several patients received a combination of suture, tacks, and surgical glue. Mean patient in-room time was 4.0 h, mean operative time was 2.9 h, and mean robotic dock time was 2.0 h. Regarding intraoperative complications, there was one bladder injury, which was discovered intraoperatively and repaired primarily. Same-day discharges were achieved in 32 patients (74.4%) of patients. One patient was admitted overnight for management of urinary retention. Additional ten patients were admitted for observation. Post-operatively, none of the cases resulted in wound infections. Eleven patients developed seromas and one patient was diagnosed with a groin hematoma. Median follow-up was 37.5 days, and one recurrence was reported during this time. The recurrent hernia in this case was initially discovered during a separate case and was repaired with temporary mesh. The use of the robot is safe and effective and should be considered an acceptable approach to inguinal hernia repair. Future prospective studies will help define which patients will benefit most from this technology.

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.

Maximizing Sacral Chordoma Resection by Precise 3-Dimensional Tumor Modeling in the Operating Room Using Intraoperative Computed Tomography Registration with Preoperative Magnetic Resonance Imaging Fusion and Intraoperative Neuronavigation: A Case Series.

INTRODUCTION: The primary treatment for patients with sacral chordoma is en bloc surgical resection with negative margins, which has been shown to reduce local recurrence and tumor-related morbidity. Here we describe the use of intraoperative neuronavigation using preoperative spine magnetic resonance imaging fused to intraoperative computed tomography (CT) to create 3-dimensional tumor reconstructions in the operating room for intraoperative identification of bone and soft-tissue margins for maximal safe tumor resection. METHODS: A single-institution retrospective chart review was completed to encompass our experience of 6 consecutive patients who had sacral chordoma resections using our described navigation protocol. We collected data on patient demographics, previous surgeries, radiation therapy, preoperative examination, spinal levels involved, dural involvement, estimated blood loss, surgery time, tissue diagnosis, follow-up, postoperative examination, complications, and recurrence. Primary outcome was en bloc resection with negative margins as planned preoperatively. RESULTS: Negative surgical margins were achieved in 5 of 5 patients, who were preoperatively planned for en bloc resection with negative margins. The most common levels involved were S4-S5. All patients had a stable or improved neurologic examination after en bloc surgical resection. The average follow-up was 5.4 months ± 84.6 days. No patient had residual or recurrent tumor at last follow-up. CONCLUSIONS: Magnetic resonance imaging-CT fusion and 3-dimensional reconstruction techniques using an intraoperative CT scanner with image-guided navigation to aid preoperative planning and surgical resection of sacral chordomas are not well represented in the literature. This technique can be used for planning en bloc surgical resections and for more precisely identifying tumor margins intraoperatively.

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.

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.

Preventing Rescue Surgeries by Endoscopic Clipping: A Valuable Resource in the Surgeon's Toolbox.

AIM: Over-the-scope-clip (OTSC) System is a relatively new endoluminal intervention for gastrointestinal (GI) leaks, fistulas, and bleeding. Here, we present a single center experience with the device over the course of 4 years. METHODS: Retrospective chart review was conducted for patients who received endoscopic OTSC treatment. Primary outcome is the resolution of the original indication for clip placement. Secondary outcomes are complications and time to resolution. RESULTS: Forty-one patients underwent treatment with the OTSC system from 2011 to 2015 with average follow-up of 152 days. The average age is 53.7. The most common site of clip placement was in the stomach (44%). Clips were placed after surgical complication for 28 patients (68%), endoscopic complications for 8 patients (19%), and spontaneous presentation in 5 patients (12%). Technical success was achieved in all patients. Overall, 34 patients (83%) were successfully treated. Nine patients required multiple clips and three patients required additional treatment modalities after OTSC. Four patients used the OTSC as a bridging therapy to surgery. Using OTSC for palliation versus nonpalliative indications was associated with lower rates of treatment success (50% versus 86%, P = .028). Using OTSC for symptoms <6 months had higher rates of treatment success than those experiencing longer symptoms (88% versus 65%, P = .045). There were no major morbidities or mortalities directly associated with the OTSC system. Complications from clip use were pain in two patients (5%) and hematemesis in one patient (3%). CONCLUSIONS: The OTSC System can be a very successful treatment for iatrogenic or spontaneous GI leaks and bleeds. Treatment success is more likely in patients treated within 6 months of diagnosis and less likely to when used for palliation. It was also successfully used as bridging therapy in several patients.

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.