Efficacy, Feasibility, and Safety of the X-Tack Endoscopic HeliX Tacking System: A Multicenter Experience.

BACKGROUND AND AIMS: The application of endoscopic suturing has revolutionized defect closures. Conventional over-the-scope suturing necessitates removal of the scope, placement of the device, and reinsertion. A single channel, single sequence, through-the-scope suturing device has been developed to improve this process. This study aims to describe the efficacy, feasibility, and safety of a through-the-scope suturing device for gastrointestinal defect closure. METHODS: This was a retrospective multicenter study involving 9 centers of consecutive adult patients who underwent suturing using the X-Tack Endoscopic HeliX Tacking System (Apollo Endosurgery). The primary outcomes were technical success and long-term clinical success. Secondary outcomes included adverse events, recurrence, and reintervention rates. RESULTS: In all, 56 patients (mean age 53.8, 33 women) were included. Suturing indications included fistula repair (n=22), leak repair (n=7), polypectomy defect closure (n=12), peroral endoscopic myotomy (POEM) site closure (n=7), perforation repair (n=6), and ulcers (n=2). Patients were followed at a mean duration of 74 days. Overall technical and long-term clinical success rates were 92.9% and 75%, respectively. Both technical and clinical success rates were 100% for polypectomies, POEM-site closures, and ulcers. Success rates were lower for the repair of fistulas (95.5% technical, 54.5% clinical), leaks (57.1%, 28.6%), and perforations (100%, 66.7%). No immediate adverse events were noted. CONCLUSION: This novel, through-the-scope endoscopic suturing system, is a safe and feasible method to repair defects that are ≤3 cm. The efficacy of this device may be better suited for superficial defects as opposed to full-thickness defects. Larger defects will need more sutures and probably a double closure technique to provide a reinforcement layer.

Perioperative outcomes of inpatient laparoscopic Heller myotomy and per-oral endoscopic myotomy in the United States.

BACKGROUND: Per-oral endoscopic myotomy is an alternative to pneumatic dilation and laparoscopic Heller myotomy to treat lower esophageal sphincter diseases. Laparoscopic Heller myotomy and per-oral endoscopic myotomy perioperative outcomes data come from relatively small retrospective series and 1 randomized trial. We aimed to estimate the number of inpatient procedures performed in the United States and compare perioperative outcomes and costs of laparoscopic Heller myotomy and per-oral endoscopic myotomy using a nationally representative database. METHODS: Cross-sectional retrospective analysis of hospital admissions for laparoscopic Heller myotomy or per-oral endoscopic myotomy from October 2015 through December 2018 in the National Inpatient Sample. Patient and hospital characteristics, concurrent antireflux procedures, perioperative adverse events (any adverse event and those associated with extended length of stay ≥3 days), mortality, length of stay, and costs were compared. Logistic regression evaluated factors independently associated with adverse events. RESULTS: An estimated 11,270 patients had laparoscopic Heller myotomy (n = 9,555) or per-oral endoscopic myotomy (n = 1,715) without significant differences in demographics and comorbidities. A concurrent anti-reflux procedure was more frequent with laparoscopic Heller myotomy (72.8% vs 15.5%, P < .001). Overall adverse event rate was higher with per-oral endoscopic myotomy (13.3% vs 24.8%, P < .001), and mortality was similar. Per-oral endoscopic myotomy had higher rates of adverse events associated with extended length of stay (9.3% vs 16.6%, P < .001), infectious adverse events (3.5% vs 8.2%, P < .001), gastrointestinal bleeding (3.4% vs 5.8%, P = .04), accidental injuries (3% vs 5.5%, P = .03), and thoracic adverse events (4.5% vs 9%, P < .01). Rates of adverse events of both procedures remained similar during the years of the study. Per-oral endoscopic myotomy was independently associated with adverse events. Length of stay (laparoscopic Heller myotomy: 3.2 ± 0.1 vs per-oral endoscopic myotomy: 3.7 ± 0.3 days, P = .17) and costs (laparoscopic Heller myotomy: $15,471 ± 406 vs per-oral endoscopic myotomy: $15,146 ± 1,308, P = .82) were similar. CONCLUSION: In this national database review, laparoscopic Heller myotomy had a lower rate of perioperative adverse events at similar length of stay and costs than per-oral endoscopic myotomy. Laparoscopic Heller myotomy remains a safer procedure than per-oral endoscopic myotomy for a myotomy of the distal esophagus and lower esophageal sphincter in the United States.

Effect of COVID-19 pandemic on global Bariatric surgery PRActiceS - The COBRAS study.

INTRODUCTION: There is a paucity of data in scientific literature on the impact of Coronavirus Disease 2019 (COVID-19) pandemic on bariatric surgery. The aim of this study was to evaluate the impact of COVID-19 pandemic on Bariatric Surgery globally. METHODS: We conducted a global online survey of bariatric surgeons between 16/04/20 - 15/05/20. The survey was endorsed by five national bariatric surgery societies and circulated amongst their memberships. Authors also shared the link through their personal networks, email groups, and social media. RESULTS: 703 respondents from 77 countries completed the survey. Respondents reported a drop in elective bariatric activity from a median (IQR) of 130 (60-250) procedures in 2019 to a median of 0 (0-2) between16/03/2020 and 15/04/2020 during the pandemic. The corresponding figures for emergency activity were 5 (2-10) and 0 (0-1) respectively. 441 (63%) respondents did not perform any bariatric procedures during this time period. Surgeons reported outcomes of 61 elective bariatric surgical procedures during the pandemic with 13 (21%) needing ventilation and 2 (3.3%) deaths. Of the 13 emergency bariatric procedures reported, 5 (38%) needed ventilation and 4 (31%) died. 90 (13%) surgeons reported having had to perform a bariatric surgical or endoscopic procedure without adequate Personal Protective Equipment. CONCLUSIONS: COVID-19 pandemic led to a remarkable decline in global elective and emergency bariatric surgery activity at its beginning. Both elective and emergency procedures performed at this stage of the pandemic had considerable morbidity and mortality.

ASMBS position statement on the rationale for performance of upper gastrointestinal endoscopy before and after metabolic and bariatric surgery.

The following position statement is issued by the American Society for Metabolic and Bariatric Surgery in response to inquiries made to the Society by patients, physicians, society members, hospitals, health insurance payors, the media, and others regarding the need and possible strategies for screening endoscopic examination before metabolic and bariatric surgery (MBS), as well as the rationale, indications, and strategies for postoperative surveillance for mucosal abnormalities, including gastroesophageal reflux disease and associated esophageal mucosal injuries (erosive esophagitis and Barrett's esophagus) that may develop in the long term after MBS, specifically for patients undergoing sleeve gastrectomy or Roux-en-Y gastric bypass. The general principles described here may also apply to procedures such as biliopancreatic diversion (BPD) and BPD with duodenal switch (DS); however, the paucity of procedure-specific literature for BPD and DS limits the value of this statement to those procedures. In addition, children with obesity undergoing MBS may have unique considerations and are not specifically addressed in this position statement. This recommendation is based on current clinical knowledge, expert opinion, and published peer-reviewed scientific evidence available at this time. The statement is not intended to be and should not be construed as stating or establishing a local, regional, or national standard of care. The statement will be revised in the future as additional evidence becomes available.

Roux-en-Y Gastric Bypass Downregulates Angiotensin-Converting Enzyme 2 (ACE2) Gene Expression in Subcutaneous White Adipose Tissue: A Putative Protective Mechanism Against Severe COVID-19.

The angiotensin-converting enzyme 2 (ACE2) is the receptor for the severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2). It is highly expressed in adipose tissue, possibly associated with progression to severe coronavirus disease 2019 (COVID-19) in obese subjects. We searched the Gene Expression Omnibus (GEO) and reanalyzed the GSE59034 containing microarray data from subcutaneous white adipose tissue (sWAT) biopsies from 16 women before and 2 years after RYGB, and 16 controls matched by sex, age, and BMI. After RYGB, there was a significant decrease in sWAT ACE2 gene expression (logFC=-0.4175, P=0.0015). Interestingly, after RYGB the sWAT ACE2 gene expression was significantly lower than in non-obese matched controls (LogFC=-0.32875, P=0.0014). Our data adds to the well-known benefits of RYGB, a potential protective mechanism against COVID-19.

Gastric Bypass Increases Circulating Bile Acids and Activates Hepatic Farnesoid X Receptor (FXR) but Requires Intact Peroxisome Proliferator Activator Receptor Alpha (PPARα) Signaling to Significantly Reduce Liver Fat Content.

BACKGROUND: We interrogate effects of gastric bypass (RYGB), compared with a low-calorie diet, on bile acid (BA), liver fat, and FXR, PPARα, and targets in rats with obesity and non-alcoholic fatty liver disease (NAFLD). METHODS: Male Wistar rats received a high-fat diet (obese/NAFLD, n=24) or standard chow (lean, n=8) for 12 weeks. Obese/NAFLD rats had RYGB (n=11), sham operation pair-fed to RYGB (pair-fed sham, n=8), or sham operation (sham, n=5). Lean rats had sham operation (lean sham, n=8). Post-operatively, five RYGB rats received PPARα antagonist GW6417. Sacrifice occurred at 7 weeks. We measured weight changes, fasting total plasma BA, and liver % steatosis, triglycerides, and mRNA expression of the nuclear receptors FXR, PPARα, and their targets SHP and CPT-I. RESULTS: At sacrifice, obese sham was heavier (p<0.01) than all other groups that had lost similar weight loss. Obese sham had lower BA levels and lower hepatic FXR, SHP, and CPT-I mRNA expression than lean sham (P<0.05, for all comparisons). RYGB had increased BA levels compared with obese and pair-fed sham (P<0.05, for both), while pair-fed sham had BA levels, similar to obese sham. Compared with pair-fed sham, RYGB animals had increased liver FXR and PPARα expression and signaling (P<0.05). Percentage of steatosis was lower in RYGB and lean sham, relative to obese and pair-fed sham (P<0.05, for all comparisons). PPARα inhibition after RYGB resulted in similar weight loss but higher liver triglyceride content (P=0.01) compared with RYGB alone. CONCLUSIONS: RYGB led to greater liver fat loss than low-calorie diet, an effect associated to increased fasting BA levels and increased expression of modulators of liver fat oxidation, FXR, and PPARα. However, intact PPARα signaling was necessary for resolution of NAFLD after RYGB.

Omental infarction with liquefied necrosis after Roux Y gastric bypass: case report and literature review.

Omental infarction is a rare phenomenon that can be idiopathic or secondary to a surgical intervention. Greater omentum division has been advocated to decrease tension at the gastro-jejunal anastomosis during laparoscopic Roux-en-Y gastric bypass (RYGB). We report a case of omental infraction complicated by liquefied infected necrosis presenting 3 weeks after antecolic antegastric RYGB. The patient underwent laparotomy and subtotal omentectomy with a protracted hospital course due to intra-abdominal abscesses, acute kidney injury and small bowel obstruction that were successfully managed non-operatively. We reviewed the available literature on omental infarction after RYGB, focusing on associated symptoms, possible etiology, timing of presentation, management and propose an alternative technique without omental division.

Intrathoracic sleeve gastrectomy migration with gastric volvulus treated with laparoscopic repair and conversion to gastric bypass.

A 43 years old female with laparoscopic sleeve gastrectomy (SG) and an 'anterior' hiatal hernia repair 11 years ago, presented with 3 years history dysphagia and heartburn. Upper gastrointestinal barium showed an almost complete intrathoracic migration of the SG with a partial organoaxial volvulus. Upper endoscopy revealed a 10 cm hiatal hernia with grade B esophagitis. Laparoscopic revision surgery with reduction of the gastric sleeve, standard posterior hiatal hernia repair, resection of the narrowed remnant of the SG and conversion to a gastric bypass was performed. No postoperative complications occurred. The patient is asymptomatic at 2 years of follow-up. We present the technical standards for the management and discuss the suspected pathophysiology of this rare but challenging condition.

IFSO Position Statement on the Role of Esophago-Gastro-Duodenal Endoscopy Prior to and after Bariatric and Metabolic Surgery Procedures.

One of the roles of the International Federation for the Surgery of Obesity and Metabolic Disorders (IFSO) is to provide guidance on the management of patients seeking surgery for adiposity-based chronic diseases. The role of endoscopy around the time of endoscopy is an area of clinical controversy. In 2018, IFSO commissioned a task force to determine the role of endoscopy before and after surgery for the management of adiposity and adiposity-based chronic diseases. The following position statement is issued by the IFSO Endoscopy in Bariatric/Metabolic Surgery Taskforce. It has been approved by the IFSO Scientific Committee and Executive Board. This statement is based on current clinical knowledge, expert opinion, and published peer-reviewed scientific evidence. It will be reviewed regularly.

Prospective comparison of longitudinal change in hepatic proton density fat fraction (PDFF) estimated by magnitude-based MRI (MRI-M) and complex-based MRI (MRI-C).

PURPOSE: To compare longitudinal hepatic proton density fat fraction (PDFF) changes estimated by magnitude- vs. complex-based chemical-shift-encoded MRI during a weight loss surgery (WLS) program in severely obese adults with biopsy-proven nonalcoholic fatty liver disease (NAFLD). METHODS: This was a secondary analysis of a prospective dual-center longitudinal study of 54 adults (44 women; mean age 52 years; range 27-70 years) with obesity, biopsy-proven NAFLD, and baseline PDFF ≥ 5%, enrolled in a WLS program. PDFF was estimated by confounder-corrected chemical-shift-encoded MRI using magnitude (MRI-M)- and complex (MRI-C)-based techniques at baseline (visit 1), after a 2- to 4-week very low-calorie diet (visit 2), and at 1, 3, and 6 months (visits 3 to 5) after surgery. At each visit, PDFF values estimated by MRI-M and MRI-C were compared by a paired t test. Rates of PDFF change estimated by MRI-M and MRI-C for visits 1 to 3, and for visits 3 to 5 were assessed by Bland-Altman analysis and intraclass correlation coefficients (ICCs). RESULTS: MRI-M PDFF estimates were lower by 0.5-0.7% compared with those of MRI-C at all visits (p < 0.001). There was high agreement and no difference between PDFF change rates estimated by MRI-M vs. MRI-C for visits 1 to 3 (ICC 0.983, 95% CI 0.971, 0.99; bias = - 0.13%, p = 0.22), or visits 3 to 5 (ICC 0.956, 95% CI 0.919-0.977%; bias = 0.03%, p = 0.36). CONCLUSION: Although MRI-M underestimates PDFF compared with MRI-C cross-sectionally, this bias is consistent and MRI-M and MRI-C agree in estimating the rate of hepatic PDFF change longitudinally. KEY POINTS: • MRI-M demonstrates a significant but small and consistent bias (0.5-0.7%; p < 0.001) towards underestimation of PDFF compared with MRI-C at 3 T. • Rates of PDFF change estimated by MRI-M and MRI-C agree closely (ICC 0.96-0.98) in adults with severe obesity and biopsy- proven NAFLD enrolled in a weight loss surgery program. • Our findings support the use of either MRI technique (MRI-M or MRI-C) for clinical care or by individual sites or for multi-center trials that include PDFF change as an endpoint. However, since there is a bias in their measurements, the same technique should be used in any given patient for longitudinal follow-up.

Changes in Utilization of Bariatric Surgery in the United States From 1993 to 2016.

OBJECTIVE: The aim of this study was to obtain estimates of changes in perioperative outcomes and utilization of bariatric surgery in the United States from 1993 to 2016. BACKGROUND: Bariatric surgery has evolved over the past 2 decades. Nationally representative information on changes of perioperative outcomes and utilization of surgery in the growing eligible population (class III obesity or class II obesity with comorbidities) is lacking. METHODS: Adults with obesity diagnosis who underwent primary bariatric surgery in the United States from 1993 to 2016 were identified in the National Inpatient Sample database. Estimates of the yearly number, types and cost of surgeries, patients' and hospital characteristics, complications and mortality rates were obtained. Prevalence of obesity and comorbidities were obtained from the National Health and Nutrition Examination Survey and changes in utilization of surgery were estimated. RESULTS: An estimated 1,903,273 patients underwent bariatric surgery in the United States between 1993 and 2016. Mean age was 43.9 years (79.9% women, 70.9% white race, 70.7% commercial insurance); these and other characteristics changed over time. Surgeries were exclusively open operations in 1993 (n = 8,631; gastric bypass and vertical banded gastroplasty, 49% each) and 98% laparoscopic (n = 162,969; 69.8% sleeve gastrectomy and 27.8% gastric bypass) in 2016. Complication and mortality rates peaked in 1998 (11.7% and 1%) and progressively decreased to 1.4% and 0.04% in 2016. Utilization increased from 0.07% in 1993 to 0.62% in 2004 and remained low at 0.5% in 2016. CONCLUSIONS: Perioperative safety of bariatric surgery improved over the last quarter-century. Despite growth in number of surgeries, utilization has only marginally increased. Addressing barriers for utilization may allow for greater access to surgical therapy.

Population Diversity Challenge the External Validity of the European Randomized Controlled Trials Comparing Laparoscopic Gastric Bypass and Sleeve Gastrectomy.

INTRODUCTION: Two randomized controlled trials (RCTs) from Europe recently showed similar weight loss and rates of type 2 diabetes (T2D) remission following laparoscopic gastric bypass (LRYGB) and laparoscopic sleeve gastrectomy (LSG). However, results from observational studies in the United States (US) have discordant results. We compared 1-year weight loss and T2D remission between LRYGB and LSG in a heterogeneous patient cohort from the US, albeit with similar inclusion and exclusion criteria to the European RCTs. METHODS: Logistic regression was used to propensity match LSG and LRYGB patients according to age, gender, race, preoperative BMI, and T2D. Inclusion and exclusion criteria were adopted from the two European RCTs. Demographic, anthropometric, weight outcomes, and comorbidities prevalence were compared at baseline and 1-year follow-up. RESULTS: We included 278 patients (139 LSG and 139 RYGB; median age 42 years, 89% female, 57% black race, 22% with public health insurance, and 25% with T2D). One year after surgery, mean %EWL was 77.3 ± 19.5% with LRYGB and 63.1 ± 21% with LSG (P < 0.001). Mean %TWL was 34.2 ± 7.3% after LRYGB and 28.1 ± 8.2% after LSG, (P < 0.001). The proportion of patients who achieved T2D remission was comparable between surgeries (LRGYB: 68.6% vs. LSG: 66.7%, P = 0.89). LSG, older age, black race, and higher preoperative BMI were independently associated with lower %EWL. Independent correlates of weight loss were different for LRYGB and LSG. CONCLUSIONS: Weight loss, but not the likelihood of T2D remission, was greater with LRYGB than LSG in a diverse patient cohort in the US. Further research efforts connecting population diversity to discordant results across studies is needed to better counsel patients with regards to expected postoperative outcomes.

Perioperative outcomes and cost of robotic-assisted versus laparoscopic inguinal hernia repair.

BACKGROUND: Utilization of robotic-assisted inguinal hernia repair (IHR) has increased in recent years, but randomized or prospective studies comparing outcomes and cost of laparoscopic and Robotic-IHR are still lacking. With conflicting results from only five retrospective series available in the literature comparing the two approaches, the question remains whether current robotic technology provides any added benefits to treat inguinal hernias. We aimed to compare perioperative outcomes and costs of Robotic-IHR versus laparoscopic totally extraperitoneal IHR (Laparoscopic-IHR). METHODS: Retrospective analysis of consecutive patients who underwent Robotic-IHR or Laparoscopic-IHR at a dedicated MIS unit in the USA from February 2015 to June 2017. Demographics, anthropometrics, the proportion of bilateral and recurrent hernias, operative details, cost, length of stay, 30-day readmissions and reoperations, and rates and severity of complications were compared. RESULTS: 183 patients had surgery: 45 (24.6%) Robotic-IHR and 138 (75.4%) Laparoscopic-IHR. There were no differences between groups in age, gender, BMI, ASA class, the proportion of bilateral hernias and recurrent hernias, and length of stay. Operative time (Robotic-IHR: 116 ± 36 min, vs. Laparoscopic-IHR: 95±44 min, p < 0.01), reoperations (Robotic-IHR: 6.7%, vs. Laparoscopic-IHR: 0%, p = 0.01), and readmissions rates were greater for Robotic-IHR. While the overall perioperative complication rate was similar in between groups (Robotic-IHR: 28.9% vs. Laparoscopic-IHR: 18.1%, p = 0.14), Robotic-IHR was associated with a significantly greater proportion of grades III and IV complications (Robotic-IHR: 6.7% vs. Laparoscopic-IHR: 0%, p = 0.01). Total hospital cost was significantly higher for the Robotic-IHRs ($9993 vs. $5994, p < 0.01). The added cost associated with the robotic device itself was $3106 per case and the total cost of disposable supplies was comparable between the 2 groups. CONCLUSIONS: In the setting in which it was studied, the outcomes of Laparoscopic-IHR were significantly superior to the Robotic-IHR, at lower hospital costs. Laparoscopic-IHR remains the preferred minimally invasive surgical approach to treat inguinal hernias.