Sleeve gastrectomy morphology and long-term weight-loss and gastroesophageal reflux disease outcomes.

BACKGROUND: The relationship between sleeve gastrectomy (SG) morphology and long-term weight-loss and gastroesophageal reflux disease (GERD) outcomes is unknown. METHODS: All patients (n = 268) undergoing SG performed by 3 surgeons at a single academic institution from January 1, 2010 to December 31, 2012 were included. Long-term weight-loss and GERD outcomes were available for 90 patients which were incorporated in analyses. SG morphology was determined from postoperative day 1 upper gastrointestinal series (UGIS) available from 50 patients. Images were independently categorized using previously published methodology as Dumbbell (38%), Lower Pouch (22%), Tubular (26%), or Upper Pouch (14%) by Radiologist and Surgeon. Radiologist categorization was used when disagreement occurred (8%). Univariable analyses were conducted to explore potential associations between SG morphology, weight loss, and GERD outcomes. RESULTS: Follow-up was 8.2 ± 0.9 years. Population characteristics included age of 45.1 ± 10.8 years, female sex in 83.3%, and hiatal hernia repair (HHR) performed at index SG in 17.8%. Surgeons did not preferentially achieve a specific SG morphology. Changes from preoperative obesity and associated diseases comprised body mass index (BMI) (49.5 ± 7.6 vs. 39.2 ± 9.4 kg/m2; p < 0.0001), diabetes mellitus (30.0 vs. 12.2%; p = 0.0006), hypertension (70.0 vs. 54.4%; p = 0.0028), hyperlipidemia (42.2 vs. 24.2%;p = 0.0017), obstructive sleep apnea (41.1 vs. 15.6%; p < 0.0001), osteoarthritis (48.9 vs. 13.3%; p < 0.0001), back pain (46.5 vs. 28.9%; p = 0.0035), and medications (4.8 ± 3.3 vs. 3.7 ± 3.5; p < 0.0001). Dumbbell SG morphology was associated with lesser reduction in BMI at follow-up (--6.8 ± 7.2 vs. -12.4 ± 8.3 kg/m2; p = 0.0196) while greater BMI change was appreciated with Lower Pouch SG shape (-16.9 ± 9.9 vs. -8.4 ± 6.8 kg/m2; p = 0.0017). GERD was more prevalent at follow-up than baseline (67.8 vs. 47.8%; p < 0.0001). GERD-specific outcomes included de novo (51.1%), persistent (27.9%), worsened (58.1%), and resolved (14.0%) disease. Ten patients underwent reoperation for refractory GERD with SG morphology corresponding to Dumbbell (n = 5) and Upper Pouch (n = 1) for those with available UGIS. Univariable analyses showed that patients with GERD experienced a larger reduction in BMI compared with patients without GERD (-11.8 ± 7.7 vs. -7.0 ± 5.1 kg/m2; p = 0.0007). Patient age, surgeon, morphology category, and whether a HHR was done at index SG were not associated with the presence of any, de novo, or worsened GERD. Female sex was associated with worsened GERD (96.0 vs. 4.0%; p = 0.0455). Type of calibration device, distance from staple line to pylorus, and whether staple line reinforcement was used were not associated with SG morphology classification. CONCLUSION: This is the first study assessing the impact of SG morphology on long-term weight loss and GERD. Our data suggest an association between SG morphology and long-term weight loss but not with GERD outcomes. Current technical standards may be limited in reproducing the same SG morphology. This information may help guide the technical optimization and standardization of SG. Surgeons did not favor a specific SG morphology (1). Our results signal to a relationship between radiographic assessment of SG morphology and long-term weight-loss outcomes with Dumbbell classification correlated with lesser reduction in BMI (2a) and Lower Pouch morphology associated with superior weight loss (2b). SG, sleeve gastrectomy; BMI, body mass index.

Surgeon experience with insurance barriers to offering gastric bypass as an evidence-based operation for pathologic GERD.

INTRODUCTION: Obesity is an increasingly prevalent public health problem often associated with poorly controlled gastroesophageal reflux disease. Fundoplication has been shown to have limited long-term efficacy in patients with morbid obesity and does not address additional weight-related co-morbidities. Roux-en-Y gastric bypass (RYGB) is the gold standard operation for durable resolution of GERD in patients with obesity, and is also used as a salvage operation for GERD after prior foregut surgery. Surgeons report access to RYGB as surgical treatment for GERD is often limited by RYGB-specific benefit exclusions embedded within insurance policies, but the magnitude and scope of this problem is unknown. METHODS: A 9-item survey evaluating surgeon practice and experience with insurance coverage for RYGB for GERD was developed and piloted by a SAGES Foregut Taskforce working group. This survey was then administered to surgeon members of the SAGES Foregut Taskforce and to surgeons participating in the SAGES Bariatrics and/or Foregut Facebook groups. RESULTS: 187 surgeons completed the survey. 89% reported using the RYGB as an anti-reflux procedure. 44% and 26% used a BMI of 35 kg/m2 and 30 kg/m2 respectively as cutoff for the RYGB. 89% viewed RYGB as the procedure of choice for GERD after bariatric surgery. 69% reported using RYGB to address recurrent reflux secondary to failed fundoplication. 74% of responders experienced trouble with insurance coverage at least half the time RYGB was offered for GERD, and 8% reported they were never able to get approval for RYGB for GERD indications in their patient populations. CONCLUSION: For many patients, GERD and obesity are related diseases that are best addressed with RYGB. However, insurance coverage for RYGB for GERD is often limited by policies which run contrary to evidence-based medicine. Advocacy is critical to improve access to appropriate surgical care for GERD in patients with obesity.

A cognitive task analysis of expert surgeons performing the robotic roux-en-y gastric bypass.

BACKGROUND: The safe and effective performance of a robotic roux-en-y gastric bypass (RRNY) requires the application of a complex body of knowledge and skills. This qualitative study aims to: (1) define the tasks, subtasks, decision points, and pitfalls in a RRNY; (2) create a framework upon which training and objective evaluation of a RRNY can be based. METHODS: Hierarchical and cognitive task analyses for a RRNY were performed using semi-structured interviews of expert bariatric surgeons to describe the thoughts and behaviors that exemplify optimal performance. Verbal data was recorded, transcribed verbatim, supplemented with literary and video resources, coded, and thematically analyzed. RESULTS: A conceptual framework was synthesized based on three book chapters, three articles, eight online videos, nine field observations, and interviews of four subject matter experts (SME). At the time of the interview, SME had practiced a median of 12.5 years and had completed a median of 424 RRNY cases. They estimated the number of RRNY to achieve competence and expertise were 25 cases and 237.5 cases, respectively. After four rounds of inductive analysis, 83 subtasks, 75 potential errors, 60 technical tips, and 15 decision points were identified and categorized into eight major procedural steps (pre-procedure preparation, abdominal entry & port placement, gastric pouch creation, omega loop creation, gastrojejunal anastomosis, jejunojejunal anastomosis, closure of mesenteric defects, leak test & port closure). Nine cognitive behaviors were elucidated (respect for patient-specific factors, tactical modification, adherence to core surgical principles, task completion, judicious technique & instrument selection, visuospatial awareness, team-based communication, anticipation & forward planning, finessed tissue handling). CONCLUSION: This study defines the key elements that formed the basis of a conceptual framework used by expert bariatric surgeons to perform the RRNY safely and effectively. This framework has the potential to serve as foundational tool for training novices.

Magnetic sphincter augmentation as treatment of gastroesophageal reflux disease after sleeve gastrectomy.

The sleeve gastrectomy's efficacy for the reduction of excess weight- and obesity-related comorbidities has been consistently demonstrated though the improvement of postoperative reflux symptoms has been questionable. The purpose of this article is to offer a diagnostic and treatment algorithm for patients suffering from GERD after the sleeve gastrectomy. This article is comprised of recommendations of from a single expert bariatric and foregut surgeon. While previously thought to be a relative contraindication, evidence suggests that select patients with a history of sleeve gastrectomy can safely and effectively undergo magnetic sphincter augmentation (MSA) and achieve improved control of reflux and discontinuation of PPIs. Concomitant hiatal hernia repair with MSA is recommended. MSA is a fantastic strategy for managing GERD after sleeve gastrectomy with careful patient selection.

Interventional Radiology Obesity Therapeutics: Proceedings from the Society of Interventional Radiology Foundation Research Consensus Panel.

The Society of Interventional Radiology Foundation commissioned a Research Consensus Panel to establish a research agenda on "Obesity Therapeutics" in interventional radiology (IR). The meeting convened a multidisciplinary group of physicians and scientists with expertise in obesity therapeutics. The meeting was intended to review current evidence on obesity therapies, familiarize attendees with the regulatory evaluation process, and identify research deficiencies in IR bariatric interventions, with the goal of prioritizing future high-quality research that would move the field forward. The panelists agreed that a weight loss of >8%-10% from baseline at 6-12 months is a desirable therapeutic endpoint for future IR weight loss therapies. The final consensus on the highest priority research was to design a blinded randomized controlled trial of IR weight loss interventions versus sham control arms, with patients receiving behavioral therapy.

(S029) Managing therapeutic anticoagulation in bariatric surgery patients.

INTRODUCTION: Patients that undergo bariatric surgery are at risk of bleeding. Some obesity-related comorbidities including venous thromboembolism and heart disease can often require therapeutic anticoagulation. Previous small institutional studies have demonstrated that bariatric surgery can be performed in this patient population. This study attempts to identify best practices in stopping and restarting therapeutic anticoagulation in patients undergoing bariatric surgery. METHODS: A retrospective analysis was completed of our institution's database using anticoagulant medications to identify patients on therapeutic anticoagulation. Patients not on therapeutic anticoagulation were excluded, as well as patients that were started on therapeutic anticoagulation only in the post-operative period or those whose anticoagulation was stopped and not restarted. Indications for anticoagulation were recorded, as well as patient demographics and comorbid conditions. The patient chart was examined for when anticoagulation was stopped before surgery, when it was restarted after surgery, and whether or not the patient was therapeutically bridged. Baseline and post-operative hemoglobin values were recorded, as well as bleeding events, transfusions, reoperation, length of stay, and readmissions. Binary variables were compared across groups using Chi-square and Fisher's exact tests, and continuous variables were analyzed using T test. RESULTS: There were 2933 bariatric operations performed between January 1, 2012 and August 31, 2019. Of these patients, 64 were on therapeutic anticoagulation before and after the operation for one or more indications, including history of VTE (39), atrial fibrillation (27), clotting disorder (6), ventricular assist device (5), previous PCI (4), or mechanical valve (2). There were 4 (6.2%) patients that experienced bleeding events. All four patients were on Coumadin pre-operatively. Three patients experienced extraluminal bleeding, and one patient had intraluminal bleeding, and all events occurred within 72 h of the operation. All four patients had their anticoagulation restarted prior to the bleeding event becoming evident, with anticoagulation in these patients restarted an average of 1.25 days after surgery. There were no conditions that predisposed a patient to bleeding. There was no significant difference in amount of time anticoagulation was stopped before surgery in bleeding versus non-bleeding patients, and there appeared to be no increased risk of bleeding in patients that were on therapeutic bridging therapy. There were no thrombotic complications from the interruption in anticoagulation therapy. CONCLUSIONS: Bariatric surgery can be safely performed in patients on therapeutic anticoagulation, though this population is at greater risk for bleeding complications in the perioperative period. Meticulous hemostasis in the operating room is the most important aspect of preventing bleeding complications.

Magnetic Sphincter Augmentation Superior to Proton Pump Inhibitors for Regurgitation in a 1-Year Randomized Trial.

BACKGROUND & AIMS: Regurgitative gastroesophageal reflux disease (GERD) refractive to medical treatment is common and caused by mechanical failure of the anti-reflux barrier. We compared the effects of magnetic sphincter augmentation (MSA) with those of proton-pump inhibitors (PPIs) in a randomized trial. METHODS: Patients with moderate to severe regurgitation (assessed by the foregut symptom questionnaire) despite once-daily PPI therapy (n = 152) were randomly assigned to groups given twice-daily PPIs (n = 102) or laparoscopic MSA (n = 50) at 20 sites, from July 2015 through February 2017. Patients answered questions from the foregut-specific reflux disease questionnaire and GERD health-related quality of life survey about regurgitation, heartburn, dysphagia, bloating, diarrhea, flatulence, and medication use, at baseline and 6 and 12 months after treatment. Six months after PPI therapy, MSA was offered to patients with persistent moderate to severe regurgitation and excess reflux episodes during impedance or pH testing on medication. Regurgitation, foregut scores, esophageal acid exposure, and adverse events were evaluated at 1 year. RESULTS: Patients in the MSA group and those who crossed over to the MSA group after PPI therapy (n = 75) had similar outcomes. MSA resulted in control of regurgitation in 72/75 patients (96%); regurgitation control was independent of preoperative response to PPIs. Only 8/43 patients receiving PPIs (19%) reported control of regurgitation. Among the 75 patients who received MSA, 61 (81%) had improvements in GERD health-related quality of life improvement scores (greater than 50%) and 68 patients (91%) discontinued daily PPI use. Proportions of patients with dysphagia decreased from 15% to 7% (P < .005), bloating decreased from 55% to 25%, and esophageal acid exposure time decreased from 10.7% to 1.3% (P < .001) from study entry to 1-year after MSA (Combined P < .001). Seventy percent (48/69) of patients had pH normalization at study completion. MSA was not associated with any peri-operative events, device explants, erosions, or migrations. CONCLUSIONS: In a prospective study, we found MSA to reduce regurgitation in 95% of patients with moderate to severe regurgitation despite once-daily PPI therapy. MSA is superior to twice-daily PPIs therapy in reducing regurgitation. Relief of regurgitation is sustained over 12 months. ClinicalTrials.gov no: NCT02505945.

Correction to: Bariatric efficiency at an academic tertiary care center.

This article was updated to correct Adel Alhaj Saleh's name, incorrectly displayed as Adel A. Saleh. It is correct as displayed here: Adel (first name) Alhaj Saleh (last name).

Bariatric efficiency at an academic tertiary care center.

BACKGROUND: Operating room (OR) efficiency requires coordinated teamwork between the staff surgeon, anesthesia team, circulating nurse, surgical technician, and surgical trainee or assistant. Bariatric cases present unique challenges including difficult airways, challenging intravenous access, use of specialized surgical equipment, and synchronized exchange of orogastric tubes. The high contribution margin of these complex bariatric procedures rests on OR efficiency. OBJECTIVE: To compare the efficiency of bariatric surgeries performed by a single surgeon at a tertiary academic medical center with its inherent variability of OR staff to that of a private hospital with a standardized surgical team. METHODS: All laparoscopic Roux-en-Y gastric bypasses (LRYGB) performed by a single surgeon at University Hospitals Cleveland Medical Center (UHCMC) and a Community Affiliate (CA) from 2013 to 2015 were retrospectively reviewed. Patient demographics and preoperative comorbidities were compared. The variability of OR staff at each site was described. Four primary endpoints of the different OR phases were measured at the 2 locations and analyzed using standard statistical methods. RESULTS: The OR data of 74 cases of LRYGB at UHCMC and 106 cases at the CA were analyzed. Patient cohorts were comparable by age (45 ± 12 vs. 45 ± 10; p = 0.88), sex (82% vs. 79% female; p = 0.62), BMI (47.16 ± 7.33 vs. 45.91 ± 6.85; p = 0.25), and comorbidities. At CA, the teams who participated in LRYGB cases were fairly constant (8 circulating and scrub nurses, 4 anesthetists, 3 anesthesiologists), whereas at UHCMC there was great variability in the number of staff with 108 staff (39 circulating nurses, 57 scrub nurses/technicians, 59 anesthetists or anesthesia residents, 24 anesthesiologists) participated in LRYGB cases. There was no statistical difference between the total mean OR time and surgical time of the cases performed at the 2 sites (203 ± 59 min vs. 188 ± 39 min; p = 0.06; 152 ± 56 min; 145 ± 37 min; p = 0.36). However, the pre- and post-case times were longer at UHCMC compared to the CA (38 ± 9 min vs. 33 ± 6 min; p < 0.0001; 13 ± 6 min vs. 10 ± 3 min; p = 0.01). CONCLUSION: The academic center has much greater variability in staff for these complex bariatric procedures. There was a trend toward longer OR times at the tertiary center as demonstrated by the difference in pre- and post-case times, but the consistent surgeon and assistant allowed for consistent surgical case time regardless of the setting. The implication of variability in OR staff can be overcome by the surgeon directing the procedure itself. The opportunity for improving the efficiency of bariatric surgery should focus on the perioperative care of the patient in OR that requires everyone to be familiar with the procedure.

Is it the technique or wound protection that is key to reducing wound infections in Roux-en-Y gastric bypass procedures?

INTRODUCTION: An unusually high surgical site infection (SSI) rate after Roux-en-Y gastric bypass (RYGB) was noted on routine outcomes review. Surgeon A, who had a rate of 8.9%, utilized the transoral technique (passage down esophagus into gastric pouch) for anvil insertion for the circular-stapled gastrojejunostomy. By comparison, SSI rate was 0% for Surgeon B, who inserted anvil transabdominally (direct passage into stomach via gastrotomy) and used wound protection (wound protector and plastic drape over stapler). We sought to determine if it was the technique for anvil insertion (transoral or transabdominal) or use of wound protection that could help reduce SSIs. METHODS: In mid-2017, Surgeon A added wound protection (wound protector and plastic drape over stapler) to the transoral technique to minimize oral flora wound contamination. Surgeon B made no changes. In this study, wound-related outcomes are examined, comparing patients who underwent surgery before (Group 1) versus after (Group 2) this intervention. Statistical analysis performed utilizing t tests and Chi square analysis; p < 0.05 considered significant. RESULTS: Three hundred and thirty-three patients underwent RYGB. Group 1 consisted of 182 patients over 17 months; 151 patients over 13 months were in Group 2. Groups were similar in age, BMI, gender, and prevalence of diabetes. There was a decrease in SSIs between Group 1 and Group 2 (5 vs. 0, p = 0.04). 11 wound complications occurred in Group 1 (5 SSIs, 4 seromas and 2 hematomas); whereas 2 wound complications occurred in Group 2 (1 seroma and 1 hematoma); decrease from 6 to 1.3%, p = 0.03. CONCLUSIONS: This study demonstrates that changing technique can lead to best outcomes. There was a dramatic reduction of wound complications and complete elimination of SSIs with a change in operative technique. The higher risk of SSI with the transoral anvil insertion when preforming a circular-stapled anastomosis can be mitigated with use of wound protection.

SAGES masters program: determining the seminal articles for each pathway.

BACKGROUND: The Society of American Gastrointestinal and Endoscopic Surgeons (SAGES) has recently developed and announced its Masters Program that aims to address existing needs of practicing surgeons for lifelong learning and consists of eight clinical pathways each containing three anchoring procedures. The objective of this study was to select the seminal articles for each anchoring procedure of these pathways using a systematic methodology. METHODS: A systematic literature search of Web of Science was conducted for the most cited articles for each of the anchoring procedures of the SAGES Masters pathways. The most relevant identified articles were then reviewed by expert members of the relevant SAGES pathway committees and task forces and the seminal articles chosen for each anchoring procedure using expert consensus. RESULTS: 578 highly cited articles were identified by the original search of the literature and the seminal articles were selected for each anchoring procedure after expert review and consensus. Articles address procedural outcomes, disease pathophysiology, and surgical technique and are presented in this paper. CONCLUSIONS: We have identified seminal articles for each anchoring procedure of the SAGES Masters program pathways using a systematic methodology. These articles provide surgeon participants of this program with a great resource to improve their procedure-specific knowledge and may further benefit the larger surgical community by focusing its attention to must-read impactful work that may inform best practices.

Safety of Revision Sleeve Gastrectomy Compared to Roux-Y Gastric Bypass After Failed Gastric Banding: Analysis of the MBSAQIP.

OBJECTIVE: The aim of this study was to assess the safety of revisional surgery to laparoscopic sleeve gastrectomy (LSG) compared to laparoscopic Roux-Y gastric bypass (LRYGB) after failed laparoscopic adjustable gastric banding (LAGB). BACKGROUND: The number of reoperations after failed gastric banding rapidly increased in the United States during the last several years. A common approach is band removal with conversion to another weight loss procedure such as gastric bypass or sleeve gastrectomy in a single procedure. The safety profile of those procedures remains controversial. METHODS: Preoperative characteristics and 30-day outcomes from the Metabolic and Bariatric Surgery Accreditation and Quality Improvement Program Participant Use Files 2015 were selected for all patients who underwent a 1-stage conversion of LAGB to LSG (conv-LSG) or LRYGB (conv-LRYGB). Conv-LSG cases were matched (1:1) with conv-LRYGB patients by age (±1 year), body mass index (±1 kg/m(2)), sex, and comorbidities including diabetes, hypertension, hyperlipidemia, venous stasis, and sleep apnea. RESULTS: A total of 2708 patients (1354 matched pairs) were included in the study. The groups were closely matched as intended. The mean operative time in conv-LRYGB was significantly longer in comparison to conv-LSG patients (151 ±â€Š58 vs 113 ±â€Š45 minutes, P < 0.001). No mortality was observed in either group. Patients after conv-LRYGB had a clinically increased anastomotic leakage rate (2.07% vs 1.18%, P = 0.070) and significantly increased bleed rate (2.66% vs 0.44%, P < 0.001). Thirty-day readmission rate was significantly higher in conv-LRYGB patients (7.46% vs 3.69%, P < 0.001), as was 30-day reoperation rate (3.25% vs 1.26%, P < 0.001). The length of hospital stay was longer in conv-LRYGB. CONCLUSIONS: A single-stage conversion of failed LAGB leads to greater morbidity and higher complication rates when converted to LRYGB versus LSG in the first 30 days postoperatively. These differences are particularly notable with regards to bleed events, 30-day reoperation, 30-day readmission, operative time, and hospital stay.

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.

Laparoscopic magnetic sphincter augmentation versus double-dose proton pump inhibitors for management of moderate-to-severe regurgitation in GERD: a randomized controlled trial.

BACKGROUND AND AIMS: GERD patients frequently complain of regurgitation of gastric contents. Medical therapy with proton-pump inhibitors (PPIs) is frequently ineffective in alleviating regurgitation symptoms, because PPIs do nothing to restore a weak lower esophageal sphincter. Our aim was to compare effectiveness of increased PPI dosing with laparoscopic magnetic sphincter augmentation (MSA) in patients with moderate-to-severe regurgitation despite once-daily PPI therapy. METHODS: One hundred fifty-two patients with GERD, aged ≥21 years with moderate-to-severe regurgitation despite 8 weeks of once-daily PPI therapy, were prospectively enrolled at 21 U.S. sites. Participants were randomized 2:1 to treatment with twice-daily (BID) PPIs (N = 102) or to laparoscopic MSA (N = 50). Standardized foregut symptom questionnaires and ambulatory esophageal reflux monitoring were performed at baseline and at 6 months. Relief of regurgitation, improvement in foregut questionnaire scores, decrease in esophageal acid exposure and reflux events, discontinuation of PPIs, and adverse events were the measures of efficacy. RESULTS: Per protocol, 89% (42/47) of treated patients with MSA reported relief of regurgitation compared with 10% (10/101) of the BID PPI group (P < .001) at the 6-month primary endpoint. By intention-to-treat analysis, 84% (42/50) of patients in the MSA group and 10% (10/102) in the BID PPI group met this primary endpoint (P < .001). Eighty-one percent (38/47) of patients with MSA versus 8% (7/87) of patients with BID PPI had ≥50% improvement in GERD-health-related quality of life scores (P < .001), and 91% (43/47) remained off of PPI therapy. A normal number of reflux episodes and acid exposures was observed in 91% (40/44) and 89% (39/44) of MSA patients, respectively, compared with 58% (46/79) (P < .001) and 75% (59/79) (P = .065) of BID PPI patients at 6 months. No significant safety issues were observed. In MSA patients, 28% reported transient dysphagia; 4% reported ongoing dysphagia. CONCLUSION: Patients with GERD with moderate-to-severe regurgitation, especially despite once-daily PPI treatment, should be considered for minimally invasive treatment with MSA rather than increased PPI therapy. (Clinical trial registration number: NCT02505945.).

SAGES review of endoscopic and minimally invasive bariatric interventions: a review of endoscopic and non-surgical bariatric interventions.

BACKGROUND: With obesity continuing as a global epidemic and therapeutic technologies advancing, several novel endoscopic and minimally invasive interventions will likely become available as treatment options. With improved technologies and different treatment strategies, as well as different patient populations being targeted, there will be greater application in the treatment armamentarium of specialists dedicated to treating obesity. We sought to review the existing technology and provide a review. METHODS: Literature review was carried out for endoscopic and minimally invasive devices. Some of these products are not FDA approved, so limited data are available in their review. RESULTS: A summary of the device and data currently available on weight loss and safety profile is provided. Several products are in clinical trials or will be soon. Some of the technology has limited data and companies will be submitting their results for FDA evaluation. CONCLUSIONS: The obesity epidemic and associated weight-related diseases represent a tremendous burden to health care practitioners. As such, a multi-modal and progressive approach, with data and outcomes examined, is likely the best and most comprehensive method to care for these patients. SAGES endorses the benefits of minimally invasive and endoscopic approaches in the treatment of obesity and its related co-morbidities.

Bariatric surgery efficacy in patients with mood disorders.

BACKGROUND: Mood disorders are comorbid in patients with obesity and found in approximately 22.0% to 54.8% of patients who are eligible for bariatric surgery. Given the unclear effect of mood disorders on bariatric surgery outcomes, we aimed this study to assess the impact of mood disorders index bariatric surgery weight loss outcomes. METHODS: A retrospective study institutional database of index bariatric surgery patients at University Hospitals Cleveland Medical Center between 2016 and 2018. The primary outcome of body mass index was followed over a 4-year period. The secondary outcomes measured were mortality and suicide rates. Mood disorders defined by the Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition, included depressive and bipolar disorders obtained from electronic medical records International Classification of Diseases, Tenth Revision, coding. RESULTS: A total of 790 patients underwent bariatric surgery between 2016 and 2018. Of these, 15 patients were excluded due to death in the postoperative period or insufficient weight loss data, and a total of 775 patients (620 women and 155 men) were included. Two hundred and ninety-five (38.1%) had an electronic medical record mood disorder diagnosis before surgery, while 480 (61.9%) did not. Both groups had a significant decrease in postoperative body mass index; however, there was no significant difference in the body mass index change between the mood disorder group (mean = 37.63, standard deviation = 9.88) and the control group (mean = 38.72, standard deviation = 9.54; t[294] = 1.40; P = .1634). CONCLUSION: Patients with mood disorders are as successful with weight loss after index bariatric surgery as those without mood disorders. There was no significant difference in mortality rates between the mood disorder group and the control group. Hence, mood disorders should not be prohibitive for weight loss surgery.

Conversion of gastric sleeve to Roux-en-Y gastric bypass: overall outcomes and predictors of below-average weight loss.

BACKGROUND: Conversion of sleeve gastrectomy (SG) to Roux-en-Y gastric bypass (RYGB) has been utilized to promote further weight loss, but results are variable in available literature. OBJECTIVES: To evaluate outcomes of SG to RYGB conversion for weight loss and to identify predictors of below-average weight loss. SETTING: University-affiliated hospital, United States. METHODS: Chart review was performed of our patients who underwent SG to RYGB conversion from November 1, 2013, to November 1, 2020. Primary outcomes were below-average percent excess weight loss (%EWL) at 1 and 2 years. Odds ratios (ORs) with 95% confidence intervals (CIs) were calculated for preconversion demographics to evaluate their relationship to the primary outcome. RESULTS: Sixty-two patients underwent conversion from SG to RYGB with weight loss as a goal. One-year data was available for 47 patients. The average %EWL at 1 year was 41.5%. Twenty-six patients had below-average %EWL at 1 year. Interval to conversion <2 years (OR = 4.41, 95% CI [1.28,15.17], P = .019) and preconversion body mass index (BMI) >40 (OR = 4.00, 95% CI [1.17,13.73], P = .028) were statistically significant predictors of below-average 1-year %EWL. Two-year data was available for 36 patients. The average %EWL at 2 years was 30.8%. Seventeen patients had below-average %EWL at 2 years. Evaluated demographics were not statistically significant predictors of below-average 2-year %EWL. CONCLUSIONS: Following SG to RYGB conversion, %EWL outcomes are lower at 1 year (41.5%) and 2 years (30.8%) than reported values for primary RYGB. Interval to conversion <2 years and preconversion BMI >40 are predictors of below-average 1-year weight loss after conversion.

Independent association of preoperative Hill grade with gastroesophageal reflux disease 2 years after sleeve gastrectomy.

BACKGROUND: The sleeve gastrectomy (SG) is associated with postoperative gastroesophageal reflux disease (GERD). Higher endoscopic Hill grade has been linked to GERD in patients without metabolic surgery. How preoperative Hill grade relates to GERD after SG is unknown. OBJECTIVE: To explore the relationship between preoperative Hill grade and GERD outcomes 2 years after SG. SETTING: Academic hospital, United States. METHODS: All patients (n = 882) undergoing SG performed by 5 surgeons at a single academic institution from January 2015 to December 2019 were included. Complete data sets were available for 360 patients, which were incorporated in analyses. GERD was defined as the presence of a diagnosis in the medical record accompanied by pharmacotherapy. Patients with GERD postoperatively (n = 193) were compared with those without (n = 167). Univariable and multivariable analyses were conducted to explore independent associations between preoperative factors and GERD outcomes. RESULTS: The presence of any GERD increased at the postoperative follow-up of 25.2 (3.9) months compared with preoperative values (53.6% versus 41.1%; P = .0001). Secondary GERD outcomes at follow-up included de novo (41.0%), persistent (33.1%), resolved (28.4%), worsened (26.4%), and improved (12.2%) disease. Postoperative endoscopy and reoperation for GERD occurred in 26.4% and 6.7% of the sample. Patients with GERD postoperatively showed higher prevalence of Hill grade III-IV (32.6% versus 19.8%; P = .0062) and any hiatal hernia (HH) (36.3% versus 25.1%; P = .0222) compared with patients without postoperative GERD. Frequencies of gastritis, esophagitis A or B, duodenitis, and peptic ulcer disease were similar between groups. Higher prevalence of preoperative GERD (54.9% versus 25.1%; P < .0001), obstructive sleep apnea (66.8% versus 54.5%; P = .0171), and anxiety (25.4% versus 15.6%; P = .0226) was observed in patients with postoperative GERD compared with those without it. Baseline demographics, weight, other obesity-associated diseases, whether an HH was repaired at index SG, and follow-up length were statistically similar between groups. After adjusting for collinearity, preoperative GERD (odds ratio [OR] = 3.6; 95% confidence interval [CI], 2.2-5.7; P < .0001) and Hill grade III-IV (OR [95% CI]: 1.9 [1.1-3.1]; P = .0174) were independently associated with the presence of any GERD postoperatively. The preoperative presence of an HH >2 cm and whether an HH was repaired at index SG showed no independent association with GERD at follow-up. CONCLUSIONS: More than 50% of patients experienced GERD 2 years after SG. Preoperative GERD confers the highest risk for GERD postoperatively. Hill grade III-IV is independently associated with GERD after SG. Whether a hiatal hernia repair was performed did not influence GERD outcomes. Preoperative esophagogastroduodenoscopy should be obtained before SG and Hill grade routinely captured and used to counsel patients about the risk of postoperative GERD after this procedure. Hill grade may help guide the choice of metabolic operation.

Feasibility and Efficacy of Magnetic Sphincter Augmentation for the Management of Gastroesophageal Reflux Disease Post-Sleeve Gastrectomy for Obesity.

BACKGROUND: Patients with medically intractable GERD after laparoscopic sleeve gastrectomy (LSG) have limited surgical options. Fundoplication is difficult post-LSG. Roux-en-Y gastric bypass may be used as a conversion procedure but is more invasive with potential for serious complications. Magnetic sphincter augmentation (MSA) is a less invasive GERD treatment alternative. The objective of this study was to assess safety and efficacy outcomes of MSA after LSG. METHODS: The primary outcome of this observational, multicenter, single-arm prospective study was the rate of serious device and/or procedure-related adverse events (AEs). The efficacy of the LINX device was measured comparing baseline to 12-month post-implant reductions in distal acid exposure, GERD-HRQL score, and average daily PPI usage. RESULTS: Thirty subjects who underwent MSA implantation were followed 12 months post-implant. No unanticipated adverse device effects were observed. There were two adverse events deemed serious (dysphagia, pain, 6.7%) which resolved without sequelae. GERD-HRQL scores showed significant improvement (80.8%, P < 0.001), and reduction in daily PPI usage was seen (95.8%, P < 0.001). Forty-four percent of subjects demonstrated normalization or > = 50% reduction of total distal acid exposure time (baseline 16.2%, 12 months 11%; P = 0.038). CONCLUSIONS: Post-LSG, MSA showed an overall improvement of GERD symptoms, and reduction in PPI use with explants within anticipated range along with improvement in distal esophageal acid exposure time.

Turnkey algorithmic approach for the evaluation of gastroesophageal reflux disease after bariatric surgery.

Bariatric surgeries are often complicated by de-novo gastroesophageal reflux disease (GERD) or worsening of pre-existing GERD. The growing rates of obesity and bariatric surgeries worldwide are paralleled by an increase in the number of patients requiring post-surgical GERD evaluation. However, there is currently no standardized approach for the assessment of GERD in these patients. In this review, we delineate the relationship between GERD and the most common bariatric surgeries: sleeve gastrectomy (SG) and Roux-en-Y gastric bypass (RYGB), with a focus on pathophysiology, objective assessment, and underlying anatomical and motility disturbances. We suggest a stepwise algorithm to help diagnose GERD after SG and RYGB, determine the underlying cause, and guide the management and treatment.