Endoluminal bariatric and metabolic therapies: state-of-the-art.

PURPOSE OF REVIEW: The aim of this review is to present the current state of the field, highlight recent developments, and describe the clinical outcomes of these endoluminal bariatric and metabolic procedures. RECENT FINDINGS: The landscape of endoluminal devices and techniques for treating obesity has expanded significantly, with FDA-approved therapies currently available to patients with a body mass index values as high as 50 kg/m 2 . Although notable advancements have been made in this area, there is a need for further emphasis to be placed on the metabolic improvements resulting from these therapies, in addition to the conventional focus on weight loss outcomes. Some of these procedures are now FDA approved for the treatment of metabolic disease as opposed to weight loss. To achieve the most favorable results, it is imperative that all endoluminal interventions are combined with a moderately intensive diet and lifestyle program lasting at least 12 months. SUMMARY: Endoluminal metabolic and bariatric therapy represents a bridge between lifestyle counseling, pharmaceutical interventions, and the most efficacious treatment for obesity, bariatric surgery. By virtue of its minimally invasive approach, this therapy may be an appealing option for patients who are ineligible for, or averse to, bariatric surgery and who have experienced suboptimal outcomes or unable to afford medical treatments. Furthermore, these interventions may be particularly beneficial in the early stages of obesity.

Challenges of developing and executing a multi-site registry for a novel device with evolving indications for use.

BACKGROUND: The introduction of new technologies in endoscopy has been met with uncertainty, skepticism, and lack of standardization or training parameters, particularly when disruptive devices or techniques are involved. The widespread availability of a novel endoscopic suturing device (OverStitch™) for tissue apposition has enabled the development of applications of endoscopic suturing. METHODS: The American Gastroenterological Association partnered with Apollo Endosurgery to develop a registry to capture in a pragmatic non-randomized study the safety, effectiveness, and durability of endoscopic suturing in approximating tissue in the setting of bariatric revision and fixation of endoprosthetic devices. RESULTS: We highlight the challenges of the adoption of novel techniques by examining the process of developing and executing this multicenter registry to assess real-world use of this endoscopic suturing device. We also present our preliminary data on the safety and effectiveness of the novel device as it is applied in the treatment of obesity. CONCLUSIONS: The Prospective Registry for Trans-Orifice Endoscopic Suturing Applications (ES Registry) was an effective Phase 4, postmarketing registry aimed at capturing pragmatic, real-world use of a novel device. These findings serve to solidify the role of endoscopic suturing in clinical practice.

Does endoscopic mean safer? A comparison of the short-term safety of endoscopic versus laparoscopic bariatric therapies.

Background and study aims There is minimal research on real-world, large-volume data comparing endoscopic bariatric therapy (EBT) to laparoscopic bariatric therapy (LBT). This study aimed to compare 30-day postoperative morbidity and mortality outcomes of primary EBT vs LBT using the Metabolic and Bariatric Surgery Accreditation and Quality Improvement Program. Patients and methods Patients aged 18 to 80 with body mass index (BMI) 35 to 40 kg/m 2 undergoing primary procedures were included. Propensity score matching 1:50 was performed for EBT versus LBT based on age, sex, and BMI. Results We matched 211 EBTs with 9,059 LBTs. Operative length (63.9, 95 % confidence interval [CI]: 57.9, 69.8 versus 81.1, 95 % CI: 80.1, 82.1) and length of stay (0.49 days, 95 % CI: 0.29, 0.69 versus 1.43 days, 95 % CI: 1.41, 1.45) were significantly lower in the EBT group than the LBT group. There was no difference between EBT and LBT in the odds of readmission (odds ratio [OR] = 0.31, 95 % CI: 0.08, 1.25), reoperation (OR = 0.39, 95 % CI: 0.05, 2.84), or reintervention (OR = 0.98, 95 % CI: 0.24, 3.99). After controlling for chronic obstructive pulmonary disease, sleep apnea, history of myocardial infarction, hypertension requiring medications, and diabetes, EBT continued to be associated with lower odds of having any adverse event (AE) than LBT, with an OR of 0.34 (95 % CI: 0.16, 0.69). Subgroup analysis comparing EBT to laparoscopic sleeve gastrectomy (LSG) showed that EBT was associated with a lower risk having any AE than LSG, with an OR of 0.39 (95 % CI: 0.19, 0.79). Conclusions EBT is associated with a lower 30-day AE rate and shorter procedural length and length of stay than LBT, with similar rates of readmission, reintervention, and reoperation.

Gastric Mucosal Devitalization (GMD): Using the Porcine Model to Develop a Novel Endoscopic Bariatric Approach.

BACKGROUND AND AIMS: As the pig model has similar gastrointestinal anatomy and physiology to humans, we used pigs to create a gastric mucosal devitalization (GMD) model in preparation for clinical translation of this technique as an endoscopic bariatric therapy (EBT). The aims of this study were to determine the ablation parameters and technique for a successful, safe, and feasible large surface area GMD that produces weight loss. METHODS: We performed GMD using argon plasma coagulation (APC) in 3 phases. Phase 1 assessed the ablation energy required to accomplish selective mucosal ablation using ex vivo pig stomachs (n = 2). Phase 2 assessed the optimal percentage of mucosal surface area to be treated and was performed on 10 pigs. Phase 3 assessed feasibility, efficacy, and safety with 8 pigs randomized into GMD (n = 4) or sham (SH, n = 4) and survived for 1 month. Body weights (GMD, n = 4, SH, n = 4) were measured daily in phase 3 for 1 month, and relative body weights were calculated and analyzed using one-tailed Student's t-test. Percent body fat was compared between GMD and SH at baseline and 1 month post-GMD. RESULTS: Phase 1 identified the optimal ablation parameters (120 W) that were then used in phase 2. Phase 2 revealed a trend that was suggestive that the optimal percent surface area to ablate was similar to that which is removed at laparoscopic sleeve gastrectomy. In phase 3, GMD was performed over 70% surface area of the greater curvature of the stomach in four pigs. GMD pigs had significantly lower relative body weight increase compared to SH at 1 month (1.375 ± 0.085 vs 1.575 ± 0.047, p = 0.0435). MRI showed a significantly lower body fat mass at 1 month in GMD pigs (5.9 ± 0.4% vs 12.7 ± 2.3%, p = 0.026) compared to SH. CONCLUSIONS: GMD resulted in decreased weight gain in the GMD group as evidenced by a lower relative body weight at 1 month. GMD in an animal model appears to show promise as a potential weight loss therapy.

The Utility of EndoFLIP for Measuring Gastrojejunal Anastomosis Diameter and Distensibility in Patients Experiencing Weight Regain Post Roux-en-Y Gastric Bypass.

A dilated gastrojejunal anastomosis (GJA) diameter is an independent predictor of weight regain following Roux-en-Y gastric bypass (RYGB). Despite this, there is no standardized method for GJA diameter measurement. We performed a retrospective analysis to compare endoscopic visual estimation and endoluminal functional impedance planimetry (EndoFLIP) for measuring GJA diameter in patients with weight regain post-RYGB. Visual estimation was found to overestimate GJA diameter by a mean of 4.2mm ± 4.6mm when compared with EndoFLIP. Furthermore, we identified symptomatic patients with normal GJA diameter but increased distensibility, which may represent a previously unrecognized subgroup. Our findings suggest the potential utility of EndoFLIP in the evaluation of post-RYGB weight regain and support the need for prospective studies to investigate the relationship between GJA distensibility and weight regain.

Efficacy of Liraglutide to Prevent Weight Regain After Retrieval of an Adjustable Intra-gastric Balloon-a Case-Matched Study.

PURPOSE: Weight regain after balloon retrieval is a concern with all intra-gastric balloons (IGBs). The aim of this study was to evaluate the efficacy of liraglutide, a glucagon-like peptide-1 (GLP-1) agonist, to prevent weight regain following IGB retrieval. MATERIALS AND METHODS: This was a case-matched study of patients undergoing Spatz3 adjustable IGB (Spatz FGIA, Inc. NY, USA) at three outpatient clinics in Brazil between November 2015 and January 2019. Seventy-seven patients that opted to take liraglutide following IGB retrieval (IGB-L) were matched 1:1 to 198 patients that declined the medication-IGB-Alone (IGB-A). Propensity score adjustment was performed at the time of balloon retrieval on factors known to influence the choice of liraglutide. Weight and percent body fat (%BF) was measured at baseline and 9 months after IGB retrieval. % BF is defined as the total mass of fat divided by total body mass, multiplied by 100. The primary outcome was weight regain, and the secondary outcome was change in %BF 9 months after IGB retrieval. RESULTS: Propensity score matching yielded 53 matched pairs. Weight regain to the starting point was not observed in either group. There was significantly less weight regain in IGB-L compared to IGB-A, - 1.15 ± 0.94 kg versus - 0.66 ± 0.99 kg (p = 0.010) 9 months after balloon retrieval. Additionally, %BF decline in IGB-L was superior to IGB-A - 10.83 ± 1.50 versus - 7.94 ± 2.02 (p < 0.01). There was no difference in weight regain or decline in %BF based on liraglutide dose. CONCLUSION: Liraglutide has an additive benefit with respect to efficacy and a reduction in body fat when commenced after IGB retrieval. Future randomized control studies will be needed to determine the optimal dose and duration of liraglutide to achieve superior outcomes.

Endobariatrics and Metabolic Endoscopy: Can We Solve the Obesity Epidemic with Our Scope?

PURPOSE OF REVIEW: Obesity is a chronic relapsing disease that results in cardiovascular disease, diabetes mellitus, and non-alcoholic fatty liver disease. Currently, surgery represents the most effective treatment. However, the advent of minimally invasive endoscopic bariatric therapy (EBT) has shifted the treatment paradigm to less invasive, cost-effective procedures with minimal complications and recovery time that are preferred by patients. In this review, we will describe current and future EBTs, focusing on outcomes and safety. RECENT FINDINGS: The endoscope has provided an incisionless portal into the gastrointestinal tract for placement of space-occupying devices and intraluminal procedures. EBTs are no longer solely manipulating anatomic alterations; instead, they aim to improve metabolic parameters such as glycated hemoglobin, low-density lipoprotein, cholesterol, and hepatic indices by targeting the mucosal layer of the gastrointestinal tract. The endoscope has succeeded in facilitating clinically meaningful weight loss and improvement of metabolic parameters. Future, solutions to the obesity epidemic will likely entail genetic testing, evaluation of the microbiome, and delivery of personalized therapy, utilizing combination endoscopic modalities that change the anatomy and physiology of individual patients, with new targets such as the abnormal metabolic signal.

Correction to: Anatomical Configuration of the Stomach Post-Endoscopic Sleeve Gastroplasty (ESG)-What Are the Sutures Doing?

The name of author Vivek Kumbhari was misspelled in the original article.

The Effects of Bariatric Surgery and Endoscopic Bariatric Therapies on GERD: An Update.

PURPOSE OF REVIEW: Bariatric surgery and endoluminal bariatric therapies (EBTs) form an increasingly utilized therapeutic approach to treat obese patients but may worsen gastroesophageal reflux disease (GERD). In this updated article, we review the evidence on the effects of bariatric procedures on GERD. FINDINGS: Recent evidence implicates sleeve gastrectomy with the highest rates of de novo GERD and Barrett's esophagus (BE), whereas malabsorptive-restrictive procedures such as Roux-en-Y gastric bypass (RYGB) and one anastomosis gastric bypass (OAGB) were shown to have significantly lower reported rates. The intragastric balloon (IGB) has been associated with increased likelihood of GERD, whereas insufficient evidence exists linking endoscopic sleeve gastroplasty (ESG) to GERD. SUMMARY: Gastroesophageal reflux disease may be treated with some bariatric procedures but is often developed de novo as a result of the change in anatomy. Patients set to undergo bariatric surgery may benefit from pre-procedural endoscopy to choose the more suitable therapy. Further studies with objective measurements of GERD post procedure may provide more insight into the effects of bariatric therapies on reflux, especially more novel ones such as ESG.

Cryoballoon ablation for gastric pouch and/or outlet reduction in patients with weight regain post Roux-en-Y gastric bypass.

BACKGROUND: Cryoballoon ablation could induce stricture formation to achieve outlet and pouch reduction in patients regaining weight after Roux-en-Y gastric bypass (RYGB). This pilot study aimed to assess technical feasibility and short-term efficacy. METHODS: A retrospective chart review (January - November 2018) at two academic centers identified patients with weight regain post-RYGB, treated with cryoablation if pouch > 4 cm and/or outlet > 15 mm. Patients were scheduled for surveillance endoscopies at 8 weeks. RESULTS: 22 patients presented 10.5 years (SD 4.42) post-RYGB with weight regain of 30.9 kg (SD 13.7). Technical success was 89.5 % for outlet ablation and 93.0 % for pouch ablation. From baseline to 8 weeks, the outlet was reduced from 24.1 mm (95 % confidence interval [CI] 19.8 to 28.5) to 17.1 mm (95 %CI 13.1 to 21.1; P < 0.001), and pouch from 5 cm (95 %CI 4.1 to 5.9) to 3.9 cm (95 %CI 2.6 to 5.1; P < 0.05). Total body weight loss at 8 weeks was 8.1 % (SD 12.8 %). CONCLUSION: Cryoablation appears technically feasible and effective for outlet and/or pouch reduction in the short term.

The Effect of the Intra-gastric Balloon on Gastric Emptying and the DeMeester Score.

BACKGROUND AND AIMS: The mechanism of weight loss with the intra-gastric balloon (IGB) is thought to be a decrease in gastric emptying (GE); however the evidence is conflicting. Nausea, abdominal pain, and gastroesophageal reflux disease (GERD) can cause intolerance resulting in early removal. This is demoralizing for the patient and costly for the healthcare system. The ability to predict which patients will have superior weight loss and tolerance is invaluable. We sought to investigate if the IGB induced weight loss by reducing GE and the effect of the IGB on the DeMeester score. METHODS: We retrospectively reviewed prospectively collected data for patients undergoing IGB placement at a single hospital. Manometry and pH studies were performed before and with the IGB in place. Weight was measured at baseline, at removal, and 6 months later. Adverse events leading to early removal were recorded. RESULTS: Twenty-four patients were evaluated. There was a statistically significant decrease in GE for solids with the IGB (117.92 ± 150.23 vs 281.48 ± 206.49 min; p = 0.0048), but not for liquids (54.44 ± 17.97 vs 56.08 ± 43.96 min; p = 0.7228). The lower esophageal sphincter (LES) pressure did not change significantly with placement of the IGB (17.76 ± 7.39 vs 14.74 ± 7.24 mmHg; p = 0.09). On multivariate analysis, increase in DeMeester score was associated with total body weight loss (p = 0.0125) and change in GE (p = 0.038) independently. CONCLUSION: The IGB delays GE for solids, but not for liquids, and increases the DeMeester score by a mechanism other than a loss of LES pressure.

Anatomical Configuration of the Stomach Post-Endoscopic Sleeve Gastroplasty (ESG)-What Are the Sutures Doing?

INTRODUCTION AND AIM: Endoscopic sleeve gastroplasty (ESG) is a procedure in which endoscopically placed sutures involute the stomach and promote weight loss. There is limited data on the durability of these sutures. PATIENTS AND METHODS: This was a single center series of 5 patients who underwent ESG performed by a single endoscopist. Patients underwent repeat endoscopy for different clinical indications. RESULTS: ESGs were successfully reversed at 3 weeks and 1 month following index ESG without significant fibrosis or scaring. At 8 and 14 months, a few sutures had dehisced though there were extensive areas of fibrosis. By 2 years, most of the sutures had dehisced; however, the gastric volume remained reduced. CONCLUSION: This case series offers an intriguing evaluation of the anatomical changes induced by ESG.

Endoscopic sleeve gastroplasty versus high-intensity diet and lifestyle therapy: a case-matched study.

BACKGROUND AND AIMS: Endoscopic sleeve gastroplasty (ESG) is a safe and effective minimally invasive bariatric procedure. This study compared weight loss in patients undergoing ESG with that of matched patients undergoing high-intensity diet and lifestyle therapy (HIDLT). METHODS: In this case-matched study, patients were matched 2/3:1 (HIDLT/ESG) by age, sex, and body mass index (BMI). One hundred five patients (30 men) who underwent ESG + low-intensity diet and lifestyle therapy (LIDLT) between 2016 and 2018 were compared with 281 patients (92 men) who underwent HIDLT at the Johns Hopkins Medical Institutions from 2013 to 2014. Weight was evaluated 1, 3, 6, and 12 months after beginning HIDLT or post-ESG to determine the mean percent total body weight loss (%TBWL). RESULTS: Mean age across both cohorts was 48.0 ± 12.1, and baseline BMI was 40.0 ± 7.7 kg/m2. In multivariable analysis controlling for age, sex, and baseline BMI, the mean %TBWL at 1, 3, 6, and 12 months was significantly higher in patients undergoing ESG than matched patients undergoing HIDLT. Specifically, at 3 months, the mean %TBWL in the ESG cohort was 14.0% compared with 11.3% in the HIDLT cohort (P <.011), and at 12 months the mean %TBWL in the ESG cohort was 20.6% versus 14.3% in the HIDLT cohort (P < .001). ESG patients with baseline BMI ≤40 kg/m2 continued to show significantly greater %TBWL than those of the same BMI group in the HIDLT group at 1, 3, 6, and 12 months after intervention (3 months, coefficient = 3.43 [P < .001]; 12 months, coefficient = 8.14 [P < .001]). CONCLUSIONS: Through 12 months of follow-up, patients who underwent ESG achieved significantly greater weight loss than patients enrolled in HIDLT. ESG appears to be a valuable alternative for patients who experience difficulty complying with HIDLT.

Efficacy and Safety of Endoscopic Sleeve Gastroplasty: A Systematic Review and Meta-Analysis.

BACKGROUND & AIMS: Bariatric surgery is the most successful treatment for obesity. However, many patients avoid surgery due to its perceived invasive nature and fear of complications. Endoscopic sleeve gastroplasty (ESG) is a seemingly less invasive option for patients with obesity. We performed a systematic review and meta-analysis to evaluate the efficacy and safety of ESG in adults. METHODS: We searched MEDLINE, Embase, Web of Science, and Cochrane Library through July 2019. Investigated outcomes included the percent total body weight loss (TBWL), body mass index reduction, percent excess weight loss (EWL), and adverse events. RESULTS: We extracted data from 8 original studies, published from 2016 through 2019, which included a total of 1772 patients. At 6 months, mean TBWL was 15.1% (95% CI, 14.3-16.0), mean decrease in body mass index was 5.65 kg/m2 (95% CI, 5.07-6.22), and mean excess weight loss was 57.7% (95% CI, 52.0-63.4). Weight loss was sustained at 12 months and 18-24 months with a TBWL of 16.5% (95% CI, 15.2-17.8) and 17.2% (95% CI, 14.6-19.7), respectively. The pooled post-ESG rate of severe adverse events was 2.2% (95% CI, 1.6%-3.1%), including pain or nausea requiring hospitalization (n = 18, 1.08%), upper gastrointestinal bleeding (n=9, 0.56%), and peri-gastric leak or fluid collection (n = 8, 0.48%). CONCLUSIONS: In a systematic review and meta-analysis, we found ESG to produce clinically significant weight loss that was reproducible among independent centers and to have a low rate of severe adverse events. ESG appears to be an effective intervention for patients with obesity, although comparative studies and randomized controlled trials are necessary. PROSPERO Identifier: CRD42019121921.

Gastric Per-Oral Endoscopic Myotomy (G-POEM) for the Treatment of Gastric Stenosis Post-Laparoscopic Sleeve Gastrectomy (LSG).

Laparoscopic sleeve gastrectomy (LSG) has become the most common form of bariatric surgery performed worldwide. However, it is associated with potentially debilitating adverse events such as post-operative stenosis. Finding effective and minimally invasive treatments for such complications is of paramount importance. Gastric per-oral endoscopic myotomy (G-POEM) is a novel procedure developed over the past decade to treat conditions that delay gastric emptying. We present a case demonstrating the use of G-POEM in the successful endoscopic management of post-LSG gastric stenosis.

Endoscopic sleeve gastroplasty versus intragastric balloon insertion: efficacy, durability, and safety.

BACKGROUND: Intragastric balloon (IGB) placement and endoscopic sleeve gastroplasty (ESG) are reported to be safe and effective endoscopic bariatric therapies. This study aimed to compare the patient demographics and therapeutic outcomes between the IGB and ESG procedures. METHODS: This was a retrospective review of prospectively collected data from consecutive patients between December 2015 and October 2017 who underwent IGB or ESG at a single academic center. Fluid-filled IGBs implanted for a 6-month duration were used. IGB and ESG patients were subjected to identical post-procedure dietary instructions and follow-up protocols. Body weight was recorded at 1, 3, 6, and 12 months post-procedure. RESULTS: A total of 47 patients underwent IGB insertion and 58 underwent ESG. The IGB cohort had a lower baseline body mass index (BMI) than the ESG (34.5 vs. 41.5 kg/m2; P < 0.001) and a significantly lower proportion of men (2.1 % vs. 41.4 %; P < 0.001). IGB patients showed a mean (standard deviation [SD]) percentage total body weight loss (%TBWL) that was significantly lower than ESG patients at 1 month (6.6 % [2.6 %] vs. 9.9 % [2.4 %]; P < 0.001), 3 months (11.1 % [4.4 %] vs. 14.3 % [4.6 %]; P = 0.004), 6 months (15.0 % [7.6 %] vs. 19.5 % [5.7 %]; P = 0.01), and 12 months (13.9 % [9.0 %] vs. 21.3 % [6.6 %]; P = 0.005). The IGB cohort also experienced significantly more adverse events compared with the ESG (17 % vs. 5.2 %; P = 0.048). CONCLUSIONS: IGB placement and ESG result in clinically meaningful weight loss. However, ESG appears to provide clinically superior and more enduring weight loss with fewer adverse events compared with an IGB.

Endoscopic sleeve gastroplasty versus laparoscopic sleeve gastrectomy: a case-matched study.

BACKGROUND AND AIMS: Endoscopic sleeve gastroplasty (ESG) reduces the gastric lumen to a size comparable with that of laparoscopic sleeve gastrectomy (LSG). However, there is a paucity of research comparing outcomes between the 2 procedures. Our study compared the 6-month weight loss outcomes and adverse events of ESG with LSG in a case-matched cohort. METHODS: We retrospectively reviewed prospectively collected data for patients undergoing ESG or LSG at a single academic center. Weight was recorded at 1 and 6 months postprocedure, and percent total body weight loss (%TBWL) was calculated. Adverse events and new-onset Gastroesophageal Reflux Disease (GERD) were also recorded. RESULTS: A total of 54 ESG patients were matched with 83 LSG patients by age, sex, and body mass index. The proportion of patients with GERD at baseline was similar in the 2 groups (16.7% in ESG group vs 25.3% in LSG group, P = .27). At the 6-month follow-up, %TBWL (compared with baseline) was significantly lower in the ESG group compared with the LSG group (17.1% ± 6.5% vs 23.6% ± 7.6%, P < .01). ESG patients had significantly lower rates of adverse events compared with LSG patients (5.2% vs 16.9%, P < .05). New-onset GERD was also significantly lower in the ESG group compared with the LSG group (1.9% vs 14.5%, P < .05). CONCLUSIONS: ESG, a minimally invasive same-day procedure, achieved less weight loss at 6 months than LSG, with the caveat that LSG caused more adverse events and new-onset GERD than ESG.

Obesity and Pancreatic Cysts in African American Patients.

Objective Obesity is one of the risk factors for pancreatic cancer and a prognostic factor for acute-chronic pancreatitis. Aim To explore the relationship and association between obesity and pancreatic cysts over a 25-year period in African American patients. Methods We reviewed the medical records of 207 patients diagnosed with pancreatic cysts via radiology and pathology data from January 1988 to December 2012. A control group was selected from a separate group of healthy patients without a history of pancreatic disease. The patients were evaluated in five groups according to the last 20 years of diagnosis in five-year intervals. Results Most patients with pancreatic cyst (73%) were overweight (defined as a body mass index (BMI) ≥ 25), and 53% had a history of chronic pancreatitis compared to patients in the control group. There was a significant difference between the two groups; 79% of patients group were overweight (BMI ≥ 25) vs. 66% in control group (p = 0.02). The incidence of obese and overweight patients was significant (85%) during the 2008 to 2012 interval for the test group (p = 0.009). Conclusion Given the increasing proportion of obese pancreatic cyst patients in recent decades compared to the proportion noted in the 1990s, obesity plays a large role in the formation of pancreatic cysts.