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Boskoski I, Lopez-Nava G, Ravishankar A, Bove V, Matteo MV, De Siena M, Pontecorvi V, Giannetti G, Iaconelli A, Spada C, Shamah SE. Automatic endoscopic gastroplasty for the treatment of obesity: results from a prospective multicenter study (with video). Gastrointest Endosc 2025; 101:818-827. [PMID: 39307402 DOI: 10.1016/j.gie.2024.09.026] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [MESH Headings] [Track Full Text] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Received: 12/28/2023] [Revised: 08/09/2024] [Accepted: 09/17/2024] [Indexed: 11/04/2024]
Abstract
BACKGROUND AND AIMS EndoZip (Nitinotes Ltd, Cesarea, Israel) is a fully automated, operator-independent robotic endoscopic suturing device developed for gastric volume reduction and treatment of obesity. We aim to assess the efficacy and safety of EndoZip to treat patients with obesity. METHODS We conducted a prospective multicenter study and recruited 45 patients with a body mass index of 30 to 40 kg/m2. Our primary outcome was to assess the percentage of total body weight loss (%TBWL) at 12 months. The secondary outcome was to determine the safety and change in quality of life using the Influence of Weight on the Quality of Life questionnaire at 1 year. RESULTS The mean ± standard deviation age was 44.2 ± 8.8 years, and the mean ± standard deviation body mass index was 34.5 ± 2.9 kg/m2. A majority (90.7%) of patients were female. The procedure was technically successful in all patients (100%). A median of 4 (range, 3-5) full-thickness sutures were placed, and the mean procedure time was 30.8 ± 15.8 minutes. At 12 months, the mean %TBWL was 13.21 (95% confidence interval, 10.11-16.31), and 76.6% of patients achieved ≥5% TBWL. We observed significant reduction in waist circumference, glycated hemoglobin, and alanine aminotransferase levels at 12 months (P < .001). We found a significant improvement in quality of life at 12 months (51.28 ± 16.22 vs 35.8 ± 11.9, P < .001). Serious adverse events occurred in 2 patients (4.4%). The average length of stay was 1 day. CONCLUSIONS Our first-in-human study showed that the EndoZip device is safe and effective in treating obesity. The weight loss led to changes in comorbidities and improvement in quality of life. (Clinical trial registration number: NCT04773795.).
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Affiliation(s)
- Ivo Boskoski
- Digestive Endoscopy Unit, Fondazione Policlinico Universitario Agostino Gemelli Istituto di Ricovero e Cura a Carattere Scientifico, Rome, Italy; Università Cattolica del Sacro Cuore, Rome, Italy
| | | | - Asokkumar Ravishankar
- Bariatric Endoscopy Unit, HM Sanchinarro University Hospital, Madrid, Spain; Department of Gastroenterology and Hepatology, Singapore General Hospital, Singapore
| | - Vincenzo Bove
- Digestive Endoscopy Unit, Fondazione Policlinico Universitario Agostino Gemelli Istituto di Ricovero e Cura a Carattere Scientifico, Rome, Italy; Università Cattolica del Sacro Cuore, Rome, Italy
| | - Maria Valeria Matteo
- Digestive Endoscopy Unit, Fondazione Policlinico Universitario Agostino Gemelli Istituto di Ricovero e Cura a Carattere Scientifico, Rome, Italy; Università Cattolica del Sacro Cuore, Rome, Italy.
| | - Martina De Siena
- Digestive Endoscopy Unit, Fondazione Policlinico Universitario Agostino Gemelli Istituto di Ricovero e Cura a Carattere Scientifico, Rome, Italy; Università Cattolica del Sacro Cuore, Rome, Italy
| | - Valerio Pontecorvi
- Digestive Endoscopy Unit, Fondazione Policlinico Universitario Agostino Gemelli Istituto di Ricovero e Cura a Carattere Scientifico, Rome, Italy; Università Cattolica del Sacro Cuore, Rome, Italy
| | - Giulia Giannetti
- Digestive Endoscopy Unit, Fondazione Policlinico Universitario Agostino Gemelli Istituto di Ricovero e Cura a Carattere Scientifico, Rome, Italy; Università Cattolica del Sacro Cuore, Rome, Italy
| | - Amerigo Iaconelli
- Bariatric Medicine Unit, Fondazione Policlinico Universitario Agostino Gemelli IRCCS, Rome, Italy
| | - Cristiano Spada
- Digestive Endoscopy Unit, Fondazione Policlinico Universitario Agostino Gemelli Istituto di Ricovero e Cura a Carattere Scientifico, Rome, Italy; Università Cattolica del Sacro Cuore, Rome, Italy
| | - Steven E Shamah
- Gastroenterology, Hepatology, and Endoscopy Unit, Emek Medical Center, Afula, Israel
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Bi D, Jirapinyo P. Endoscopic Weight Loss Options. Endocrinol Metab Clin North Am 2025; 54:149-162. [PMID: 39919871 DOI: 10.1016/j.ecl.2024.11.002] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [Key Words] [MESH Headings] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Indexed: 02/09/2025]
Abstract
Endoscopic therapies for obesity have emerged as safe, effective, and minimally-invasive alternatives to traditional approaches, including lifestyle modification, anti-obesity medications, and bariatric surgery. Currently, in the United States, 2 types of endoscopic weight loss therapies are Food and Drug Administration (FDA)-approved and are commercially available-intragastric balloons and endoscopic gastric remodeling. These devices and procedures are associated with approximately 10% to 20% total weight loss at 1 year and have distinct technical features, benefits, and risks that providers should be familiar with. This article will focus on the primary FDA-approved endoscopic treatments for obesity and also cover those in development.
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Affiliation(s)
- Danse Bi
- Division of Gastroenterology, Hepatology, and Endoscopy, Brigham and Women's Hospital, 75 Francis Street, Boston, MA 02115, USA
| | - Pichamol Jirapinyo
- Division of Gastroenterology, Hepatology, and Endoscopy, Brigham and Women's Hospital, 75 Francis Street, Boston, MA 02115, USA; Harvard Medical School, Boston, MA 02115, USA.
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Abeid M, Zaitoun N. Endoscopic Band Ligation for Weight Loss: A Clinical Trial. Obes Surg 2025; 35:280-284. [PMID: 39707144 PMCID: PMC11717791 DOI: 10.1007/s11695-024-07609-3] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [MESH Headings] [Grants] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Received: 10/11/2024] [Revised: 11/22/2024] [Accepted: 11/26/2024] [Indexed: 12/23/2024]
Abstract
BACKGROUND AND STUDY AIM We previously reported the utility of endoscopic band ligation (EBL) in weight loss in a female patient with obesity. This study aimed to evaluate the safety of weight loss using EBL in a larger cohort. PATIENTS AND METHODS This prospective cohort study included 13 female patients aged ≥ 18 years with a body mass index of ≥ 30 kg/m2 who were unwilling to undergo bariatric surgery. Patients with obesity-related comorbidities such as diabetes, hypertension, dyslipidemia, and cardiovascular disease were included. Patients with a history of bariatric surgery and those with clinical manifestations of gastroparesis, portal hypertension, liver cirrhosis, and coagulopathies were excluded. Primary study outcomes were technical feasibility and safety, and secondary study outcomes were the percentage of total weight loss, excess weight loss, and the change in gastroparesis clinical symptom index at 1 month after surgery. RESULTS No serious complications occurred during the endoscopy or immediately after that. All patients experienced epigastric pain, nausea, and vomiting for the first 3 days, with one patient developing mild hematemesis on the second day that stopped spontaneously and revealed no abnormalities on endoscopy. At 1 month after EBL, the mean percent excess weight loss and total weight loss were 22.3% ± 9.9% and 7.8% ± 2.5%, respectively. CONCLUSIONS EBL is an effective and safe intervention for obesity management. Further studies with larger cohorts are warranted to comprehensively evaluate of the long-term efficacy and safety of EBL for obesity management.
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Dayyeh BKA, Stier C, Alqahtani A, Sharaiha R, Bandhari M, Perretta S, Jirapinyo SP, Prager G, Cohen RV. IFSO Bariatric Endoscopy Committee Evidence-Based Review and Position Statement on Endoscopic Sleeve Gastroplasty for Obesity Management. Obes Surg 2024; 34:4318-4348. [PMID: 39482444 DOI: 10.1007/s11695-024-07510-z] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [Key Words] [MESH Headings] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Received: 09/08/2024] [Revised: 09/11/2024] [Accepted: 09/16/2024] [Indexed: 11/03/2024]
Abstract
BACKGROUND Obesity is a significant global health issue. Metabolic and bariatric surgery (MBS) is the gold standard in the treatment of obesity due to its proven effectiveness and safety in the short and long term. However, MBS is not suitable for all patients. Some individuals are at high surgical risk or refuse surgical treatment, while others do not meet the criteria for MBS despite having obesity-related comorbidities. This gap has driven the development of endoscopic solutions like endoscopic sleeve gastroplasty (ESG), which offers a less invasive alternative that preserves organ function and reduces risks. A recent IFSO International Delphi consensus study highlighted that multidisciplinary experts agree on the utility of ESG for managing obesity in patients with class I and II obesity and for those with class III obesity who do not wish to pursue or qualify for MBS. This IFSO Bariatric Endoscopy Committee position statement aims to augment these consensus statements by providing a comprehensive systematic review of the evidence and delivering an evidence-based position on the value of ESG within the spectrum of obesity management. METHODS A comprehensive systematic review followed the Preferred Reporting Items for Systematic Reviews and Meta-analyses (PRISMA) and Cochrane guidelines. RESULTS Systematic Review: The systematic review included 44 articles encompassing 15,714 patients receiving ESG. The studies varied from large case series to cohort studies and a randomized controlled trial (RCT). The mean baseline BMI was 37.56 kg/m2. The review focused on weight loss outcomes and safety data. META-ANALYSIS Time point Mean %EWL Mean %TBWL 6 months 48.04 15.66 12 months 53.09 17.56 18 months 57.98 16.25 24 months 46.57 15.2 36 months 53.18 14.07 60 months 45.3 15.9 These results demonstrate significant weight loss following ESG. SAFETY The pooled serious adverse event (SAE) rate was 1.25%. This low rate of SAEs indicates that ESG is a relatively safe procedure. QUALITY OF EVIDENCE The quality of evidence from the included observational studies was assessed as very low, primarily due to the inherent limitations associated with observational study designs, such as potential biases and lack of randomization. In contrast, the quality of evidence from the single randomized controlled trial was rated as MODERATE, reflecting a more robust study design that provides a higher level of evidence despite some limitations. CONCLUSIONS The IFSO Bariatric Endoscopy Committee, after conducting a comprehensive systematic review and meta-analysis, endorses endoscopic sleeve gastroplasty (ESG) as an effective and valuable treatment for obesity. ESG is particularly beneficial for patients with class I and II obesity, as well as for those with class III obesity who are not suitable candidates for metabolic bariatric surgery. ESG provides significant weight loss outcomes and demonstrates a favorable safety profile with a low rate of serious adverse events. Despite the limitations of the included observational studies, the randomized controlled trial included in the analysis reinforces the efficacy and safety of ESG and provides an evidence-based foundation for the position statement. Thus, the IFSO position statement supports and provides an evidence base for the role of ESG within the broader spectrum of obesity management.
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Affiliation(s)
- Barham K Abu Dayyeh
- Mayo Clinic, Rochester, USA.
- Gastroenterology and Advanced Endoscopy, Cedars-Sinai Health System, Los Angeles, USA.
| | | | | | | | - Mohit Bandhari
- Sri Aurobindo Medical College and PG Institute, Indore, India
| | | | | | | | - Ricardo V Cohen
- The Center for Obesity and Diabetes, Oswaldo Cruz German Hospital, San Paolo, Brazil
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Diab ARF, Sujka JA, Mattingly K, Sachdeva M, Hackbarth K, Docimo S, DuCoin CG. The Battle of Endoscopic Bariatric Therapies for Obesity: Endoscopic Sleeve Gastroplasty Versus Endoscopically Inserted Intragastric Balloon-A Pairwise Meta-Analysis of Comparative Studies and a Call for Randomized Controlled Trials. Surg Laparosc Endosc Percutan Tech 2024; 34:638-646. [PMID: 39297573 DOI: 10.1097/sle.0000000000001321] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [MESH Headings] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Received: 05/12/2024] [Accepted: 08/12/2024] [Indexed: 12/06/2024]
Abstract
BACKGROUND Endoscopic sleeve gastroplasty (ESG) represents the latest primary endoscopic intervention for managing obesity. Both ESG and intragastric balloons (IGBs) have demonstrated effectiveness and safety for weight loss. However, there is a paucity of high-quality evidence supporting the superiority of one over the other, and no pairwise meta-analysis of comparative studies has been published to date. Our aim was to conduct a pairwise meta-analysis of comparative studies directly comparing ESG and IGB. METHODS We systematically conducted a literature search on PubMed and Google Scholar following the Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA) guidelines. Our search used specific search terms. The Risk of Bias in Non-Randomized Studies of Interventions (ROBINS-I) Tool was used to evaluate the quality of the included studies. Data were analyzed using Review Manager (RevMan) 5.4.1 software with a random-effects model. The statistical method used was the Mantel-Haenszel method. For dichotomous data, the effect size was represented using odds ratio (OR), while mean difference (MD) was utilized as the effect size for continuous data. RESULTS After screening 967 records, a total of 9 studies met the inclusion criteria for this meta-analysis (5302 patients). The quality assessment categorized 5 studies as having a moderate risk of bias, while 3 studies were classified as having a low risk of bias. Sufficient information was not available for one study to ascertain its overall quality. A statistically significant increase in total weight loss percentage (TWL%) at 1 and 6 months was observed with ESG compared with IGB. In addition, a statistically insignificant decrease in the incidence of adverse events and readmissions was observed with ESG. Furthermore, a statistically significant decrease in the incidence of reintervention was observed with ESG. CONCLUSIONS While this study suggests a higher TWL% associated with ESG compared with IGB, drawing definitive conclusions is challenging due to limitations identified during a comprehensive quality assessment of the available literature. We advocate for randomized controlled trials (RCTs) directly comparing the newer IGB (with a 12-mo placement duration) with ESG. However, this study consistently reveals higher rates of early reintervention (re-endoscopy) within the IGB group, primarily necessitated by the removal or adjustment of the IGB due to intolerance. Given the additional intervention required at 6 or 12 months to remove the temporarily placed IGB, this trend may imply that IGB is less economically viable than ESG. Cost-effectiveness analyses comparing ESG and IGB are warranted to provide valuable scientific insights.
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Affiliation(s)
- Abdul-Rahman F Diab
- Department of Surgery, Division of Gastrointestinal Surgery, University of South Florida Morsani College of Medicine, Tampa
- University of Central Florida, HCA Healthcare GME, Ocala, FL
| | - Joseph A Sujka
- Department of Surgery, Division of Gastrointestinal Surgery, University of South Florida Morsani College of Medicine, Tampa
| | | | - Mehak Sachdeva
- University of Central Florida, HCA Healthcare GME, Ocala, FL
| | | | - Salvatore Docimo
- Department of Surgery, Division of Gastrointestinal Surgery, University of South Florida Morsani College of Medicine, Tampa
| | - Christopher G DuCoin
- Department of Surgery, Division of Gastrointestinal Surgery, University of South Florida Morsani College of Medicine, Tampa
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Fernicola A, Palomba G, Calogero A, Santangelo M, Salvucci A, Verlingieri V, Scognamiglio G. Endoscopic Sleeve Gastroplasty for the Treatment of Obesity: A Single-Centre Experience and Literature Review. Cureus 2024; 16:e71064. [PMID: 39512985 PMCID: PMC11541639 DOI: 10.7759/cureus.71064] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Figures] [Journal Information] [Subscribe] [Scholar Register] [Accepted: 10/08/2024] [Indexed: 11/15/2024] Open
Abstract
BACKGROUND In the world, obesity is constantly increasing, and so are the types of medical and surgical therapies. However, to cope with the increase in costs associated with surgical procedures and certain complications, such as gastroesophageal reflux disease, the number of bariatric endoscopic (BE) procedures has been increasing in recent years. Endoscopic sleeve gastroplasty (ESG) is one of the most rapidly increasing BE procedures, given its benefits in terms of patient quality of life and reduced costs. In fact, it is a procedure characterised by minimal postoperative complications and is applicable to different types of bariatric patients. However, the number of studies on BE is not comparable to that on bariatric surgery. METHODS We analyzed the results of 84 ESG performed in our centre and compared them with those presented in the literature. We evaluated 36-Item Short Form Health Survey (SF-36) to 0, six and 13 months, signs and symptoms of patients undergoing ESG on the first and second postoperative day (POD), in terms of abdominal pain, nausea and vomiting. We found a reduction of these outcomes from POD 1 to POD 2. Finally, we measured total body weight loss percentage (TBWL%) and excess weight loss percentage (EWL%) at three, six and 12 months both in patients undergoing bariatric surgery for the first time (specifically, ESG) and in patients previously undergoing bariatric surgery and then undergoing ESG. RESULTS Using the SF-36 score, we observed an improvement in the physical (mean score from 46.4 at time 0 to 53.6 at 12 months from the ESG) and mental (mean score from 37 at time 0 to 39.9 at 12 months from the ESG) status of the patients. Furthermore, we observed a 0 to 12-month increase in TBWL% and EWL% from the ESG procedure. Furthermore, we observed an increase in TBWL% and EWL% at three, six and 12 months both in patients undergoing bariatric surgery for the first time (specifically ESG) and in patients previously undergoing bariatric surgery and then undergoing ESG. CONCLUSION ESG was an effective, reversible, and repeatable surgical procedure for bariatric patients.
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Affiliation(s)
- Agostino Fernicola
- Department of Clinical Medicine and Surgery, Division of Endoscopic Surgery, Azienda Ospedaliera Universitaria Federico II, Naples, ITA
| | - Giuseppe Palomba
- Department of Clinical Medicine and Surgery, Division of Endoscopic Surgery, Azienda Ospedaliera Universitaria Federico II, Naples, ITA
| | - Armando Calogero
- Department of Advanced Biomedical Sciences, Division of Emergency Surgery, Azienda Ospedaliera Universitaria Federico II, Naples, ITA
| | - Michele Santangelo
- Department of Advanced Biomedical Sciences, Division of Emergency Surgery, Azienda Ospedaliera Universitaria Federico II, Naples, ITA
| | - Alessandro Salvucci
- Department of General Surgery, Ospedale Santa Maria della Pietà dei Religiosi Camilliani, Naples, ITA
| | - Viviana Verlingieri
- Department of General Surgery, Ospedale Santa Maria della Pietà dei Religiosi Camilliani, Naples, ITA
| | - Giuseppe Scognamiglio
- Department of General Surgery, Ospedale Santa Maria della Pietà dei Religiosi Camilliani, Naples, ITA
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Stroh C, Luderer D, Arnold F, Rusnak R. Chirurgische Therapie der Adipositas. DIE DIABETOLOGIE 2024; 20:349-355. [DOI: 10.1007/s11428-024-01158-0] [Citation(s) in RCA: 1] [Impact Index Per Article: 1.0] [Reference Citation Analysis] [Track Full Text] [Subscribe] [Scholar Register] [Accepted: 01/31/2024] [Indexed: 01/03/2025]
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Matteo MV, Bove V, Ciasca G, Carlino G, Di Santo R, Vinti L, Polidori G, Pontecorvi V, Papi M, Spada C, Boškoski I. Success Predictors of Endoscopic Sleeve Gastroplasty. Obes Surg 2024; 34:1496-1504. [PMID: 38451369 PMCID: PMC11031450 DOI: 10.1007/s11695-024-07109-4] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [Key Words] [MESH Headings] [Grants] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Received: 09/20/2023] [Revised: 02/09/2024] [Accepted: 02/15/2024] [Indexed: 03/08/2024]
Abstract
OBJECTIVE Endoscopic sleeve gastroplasty (ESG) is a minimally invasive procedure that proved to be safe and effective in obesity treatment. However, not all subjects respond to treatment in the same way, and, with a view to personalized care, it is essential to identify predictors of success or failure. METHODS A retrospective 2-year followed-up cohort of ESG subjects was analyzed to investigate the presence of any baseline or early indicators of long-term optimal or suboptimal ESG outcomes. RESULTS A total of 315 subjects (73% women) were included, with 73% of patients exhibiting an Excess weight loss percentage (%EWL) >25% at the 24 months. Neither demographic parameters (age and sex), smoking habits, and menopause in women nor the presence of comorbidities proved potential predictive value. Interestingly, the %EWL at 1 month after ESG was the strongest predictor of 24-month therapeutic success. Subsequently, we estimated an "early threshold for success" for 1 month-%EWL by employing Youden's index method. CONCLUSIONS ESG is a safe and effective bariatric treatment that can be offered to a wide range of subjects. Early weight loss seems to impact long-term ESG results significantly and may allow proper early post-operative care optimization.
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Affiliation(s)
- Maria Valeria Matteo
- Digestive Endoscopy Unit, Fondazione Policlinico Universitario Agostino Gemelli IRCCS, Largo A. Gemelli, 8, 00168, Rome, Italy
- Università Cattolica del Sacro Cuore, 00168, Roma, Italy
| | - Vincenzo Bove
- Digestive Endoscopy Unit, Fondazione Policlinico Universitario Agostino Gemelli IRCCS, Largo A. Gemelli, 8, 00168, Rome, Italy
- Università Cattolica del Sacro Cuore, 00168, Roma, Italy
| | - Gabriele Ciasca
- Fondazione Policlinico Universitario A. Gemelli IRCCS, 00168, Roma, Italy
- Dipartimento di Neuroscienze, Sezione di Fisica, Università Cattolica Del Sacro Cuore, 00168, Roma, Italy
| | - Giorgio Carlino
- Digestive Endoscopy Unit, Fondazione Policlinico Universitario Agostino Gemelli IRCCS, Largo A. Gemelli, 8, 00168, Rome, Italy
- Università Cattolica del Sacro Cuore, 00168, Roma, Italy
| | - Riccardo Di Santo
- Fondazione Policlinico Universitario A. Gemelli IRCCS, 00168, Roma, Italy
- Dipartimento di Neuroscienze, Sezione di Fisica, Università Cattolica Del Sacro Cuore, 00168, Roma, Italy
| | - Laila Vinti
- Digestive Endoscopy Unit, Fondazione Policlinico Universitario Agostino Gemelli IRCCS, Largo A. Gemelli, 8, 00168, Rome, Italy
| | - Giulia Polidori
- Department of Translational and Precision Medicine, Sapienza University of Rome, Roma, Italy
| | - Valerio Pontecorvi
- Digestive Endoscopy Unit, Fondazione Policlinico Universitario Agostino Gemelli IRCCS, Largo A. Gemelli, 8, 00168, Rome, Italy
| | - Massimiliano Papi
- Fondazione Policlinico Universitario A. Gemelli IRCCS, 00168, Roma, Italy
- Dipartimento di Neuroscienze, Sezione di Fisica, Università Cattolica Del Sacro Cuore, 00168, Roma, Italy
| | - Cristiano Spada
- Digestive Endoscopy Unit, Fondazione Policlinico Universitario Agostino Gemelli IRCCS, Largo A. Gemelli, 8, 00168, Rome, Italy.
- Università Cattolica del Sacro Cuore, 00168, Roma, Italy.
| | - Ivo Boškoski
- Digestive Endoscopy Unit, Fondazione Policlinico Universitario Agostino Gemelli IRCCS, Largo A. Gemelli, 8, 00168, Rome, Italy
- Università Cattolica del Sacro Cuore, 00168, Roma, Italy
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Haseeb M, Chhatwal J, Xiao J, Jirapinyo P, Thompson CC. Semaglutide vs Endoscopic Sleeve Gastroplasty for Weight Loss. JAMA Netw Open 2024; 7:e246221. [PMID: 38607627 PMCID: PMC11015347 DOI: 10.1001/jamanetworkopen.2024.6221] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [MESH Headings] [Grants] [Track Full Text] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Received: 11/01/2023] [Accepted: 02/13/2024] [Indexed: 04/13/2024] Open
Abstract
Importance Obesity is a disease with a large socioeconomic burden. Endoscopic sleeve gastroplasty (ESG) is a minimally invasive endoscopic bariatric procedure with wide global adoption. More recently, new weight-loss medications, such as glucagon-like peptide-1 receptor agonists (eg, semaglutide), have attracted increased attention due to their efficacy. However, their cost-effectiveness over an extended period compared with ESG is a critical gap that needs to be better explored for informed health care decision-making. Objective To assess the cost-effectiveness of semaglutide compared with ESG over 5 years for individuals with class II obesity. Design, Setting, and Participants This economic evaluation study, conducted from September 1, 2022, to May 31, 2023, used a Markov cohort model to compare ESG and semaglutide, with a no-treatment baseline strategy. The study comprised adult patients in the US health care system with class II obesity (body mass index [BMI] of 35-39.9). The base case was a 45-year-old patient with class II obesity (BMI of 37). Patients undergoing ESG were subjected to risks of perioperative mortality and adverse events with resultant costs and decrement in quality of life. Interventions Strategies included treatment with semaglutide and ESG. Main Outcomes and Measures Costs (2022 US dollars), quality-adjusted life-years (QALYs), and incremental cost-effectiveness ratio (ICER) with a willingness-to-pay threshold of $100 000/QALY. A 5-year time horizon with a cycle length of 1 month with a 3% discount rate was used. Probabilities, costs, and quality-of-life estimates of the model were derived from published literature. One-way, 2-way, and probabilistic sensitivity analyses were also performed. Results The model found that ESG was more cost-effective than semaglutide over a 5-year time horizon, with an ICER of -$595 532/QALY. Endoscopic sleeve gastroplasty added 0.06 QALYs and reduced total cost by $33 583 relative to semaglutide. The results remained robust on 1-way and probabilistic sensitivity analyses. Endoscopic sleeve gastroplasty sustained greater weight loss over 5 years vs semaglutide (BMI of 31.7 vs 33.0). To achieve nondominance, the annual price of semaglutide, currently $13 618, would need to be $3591. Conclusions and Relevance This study suggests that ESG is cost saving compared with semaglutide in the treatment of class II obesity. On price threshold analyses, a 3-fold decrease in the price of semaglutide is needed to achieve nondominance.
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Affiliation(s)
- Muhammad Haseeb
- Division of Gastroenterology, Hepatology and Endoscopy, Brigham and Women’s Hospital, Boston, Massachusetts
- Department of Gastroenterology, Hepatology and Nutrition, University of Pittsburgh Medical Center, Pittsburgh, Pennsylvania
| | - Jagpreet Chhatwal
- Institute for Technology Assessment, Massachusetts General Hospital, Boston
| | - Jade Xiao
- Georgia Institute of Technology, Atlanta
| | - Pichamol Jirapinyo
- Division of Gastroenterology, Hepatology and Endoscopy, Brigham and Women’s Hospital, Boston, Massachusetts
| | - Christopher C. Thompson
- Division of Gastroenterology, Hepatology and Endoscopy, Brigham and Women’s Hospital, Boston, Massachusetts
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Maselli DB, Kucera A, Chapman CG, Coan B, Waseem A, Wooley C, McGowan CE. The endoscopic bariatric patient: characteristics, beliefs, and fears. IGIE 2024; 3:82-91. [DOI: 10.1016/j.igie.2023.12.004] [Citation(s) in RCA: 1] [Impact Index Per Article: 1.0] [Reference Citation Analysis] [Track Full Text] [Subscribe] [Scholar Register] [Indexed: 01/03/2025]
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Brunaldi VO, Galvao Neto M, Sharaiha RZ, Hoff AC, Bhandari M, McGowan C, Ujiki MB, Kedia P, Ortiz E, VanderWel B, Abu Dayyeh BK. Endoscopic sleeve gastroplasty as an early tool against obesity: a multicenter international study on an overweight population. Gastrointest Endosc 2024; 99:371-376. [PMID: 37852330 DOI: 10.1016/j.gie.2023.10.033] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [MESH Headings] [Track Full Text] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Received: 04/26/2023] [Revised: 09/15/2023] [Accepted: 10/12/2023] [Indexed: 10/20/2023]
Abstract
BACKGROUND AND AIMS Endoscopic sleeve gastroplasty (ESG) is an effective, minimally invasive gastric remodeling procedure to treat mild and moderate obesity. Early adoption of ESG may be desirable to try to halt progression of obesity, but there are few data on its efficacy and safety for overweight patients. METHODS This was a multicenter, international, analytical case series. Six U.S., 1 Brazilian, 1 Mexican, and 1 Indian center were included. Overweight patients according to local practice undergoing ESG were considered eligible for the study. The end points were percent total weight loss (%TWL), body mass index (BMI) reduction, rate of BMI normalization, and rate of adverse events. RESULTS One hundred eighty-nine patients with a mean age of 42.6 ± 14.1 years and a mean BMI of 27.79 ± 1.17 kg/m2 were included. All procedures were successfully accomplished, and there were 3 intraprocedural adverse events (1.5%). The mean %TWL was 12.28% ± 3.21%, 15.03% ± 5.30%, 15.27% ± 5.28%, and 14.91% ± 5.62% at 6, 12, 24, and 36 months, respectively. At 12 and 24 months, 76% and 86% of patients achieved normal BMI, with a mean BMI reduction of 4.13 ± 1.46 kg/m2 and 4.25 ± 1.58 kg/m2. There was no difference in mean %TWL in the first quartile versus the fourth quartile of BMI in any of the time points. However, the BMI normalization rate was statistically higher in the first group at 6 and 12 months (6 months, 100% vs 48.5% [P < .01]; 12 months, 86.2% vs 50% [P < .01]; 24 months, 84.6% vs 76.1% [P = .47]; 36 months, 86.3% vs 66.6% [P = .26]). CONCLUSIONS ESG is safe and effective in treating overweight patients with high BMI normalization rates. It could help halt or delay the progression to obesity.
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Affiliation(s)
| | - Manoel Galvao Neto
- Mohak Bariatric and Robotic Center, Indore, India; Elias Ortiz & Company, Tijuana, Mexico; Endovitta Institute, São Paulo, Brazil
| | - Reem Z Sharaiha
- Division of Gastroenterology and Hepatology, Weill Cornell Medicine, New York, New York, USA
| | | | | | | | - Michael B Ujiki
- Department of Surgery, University of Chicago, Pritzker School of Medicine, Chicago, Illinois, USA
| | | | | | | | - Barham K Abu Dayyeh
- Gastroenterology and Hepatology Division, Mayo Clinic, Rochester, Minnesota, USA.
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12
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Gala K, Brunaldi V, McGowan C, Sharaiha RZ, Maselli D, Vanderwel B, Kedia P, Ujiki M, Wilson E, Vargas EJ, Storm AC, Abu Dayyeh BK. Performance of Endoscopic Sleeve Gastroplasty by Obesity Class in the United States Clinical Setting. Clin Transl Gastroenterol 2024; 15:e00647. [PMID: 37787450 PMCID: PMC10810569 DOI: 10.14309/ctg.0000000000000647] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [Key Words] [MESH Headings] [Track Full Text] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Received: 08/08/2023] [Accepted: 09/19/2023] [Indexed: 10/04/2023] Open
Abstract
INTRODUCTION Endoscopic sleeve gastroplasty (ESG) has gained popularity over the past decade and has been adopted in both academic and private institutions globally. We present outcomes of the largest cohort of patients from the United States undergoing ESG and evaluate these according to obesity class. METHODS We performed a retrospective analysis of adult patients who underwent ESG. Medical information was abstracted from the electronic record with weight records up to 2 years after ESG. Percent total body weight loss (%TBWL) at 6, 12, 18, and 24 months was calculated based on baseline weight at the procedure. SPSS (version 29.0) was used for all statistical analyses. RESULTS A total of 1,506 patients from 7 sites were included (501 Class I obesity, 546 Class II, and 459 Class III). Baseline demographics differed according to obesity class due to differences in age, body mass index (BMI), height, sex distribution, and race. As early as 6 months post-ESG, mean BMI for each class dropped to the next lower class and remained there through 2 years. %TWBL achieved in the Class III group was significantly greater when compared with other classes at all time points. At 12 months, 83.2% and 60.9% of patients had ≥10% and ≥15% TBWL for all classes. There were no differences in adverse events between classes. DISCUSSION Real-world data from a large cohort of patients of all BMI classes across the United States shows significant and sustained weight loss with ESG. ESG is safe to perform in a higher obesity class with acceptable midterm efficacy.
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Affiliation(s)
- Khushboo Gala
- Division of Gastroenterology and Hepatology, Mayo Clinic, Rochester, Minnesota, USA
| | - Vitor Brunaldi
- Division of Gastroenterology and Hepatology, Mayo Clinic, Rochester, Minnesota, USA
| | | | - Reem Z. Sharaiha
- Division of Gastroenterology and Hepatology, Weill Cornell Medicine, New York, New York, USA
| | | | | | | | - Michael Ujiki
- NorthShore University Health System, Evanston, Illinois, USA
| | - Eric Wilson
- University of Texas Health Science Center—Houston, Houston, Texas, USA
| | - Eric J. Vargas
- Division of Gastroenterology and Hepatology, Mayo Clinic, Rochester, Minnesota, USA
| | - Andrew C. Storm
- Division of Gastroenterology and Hepatology, Mayo Clinic, Rochester, Minnesota, USA
| | - Barham K. Abu Dayyeh
- Division of Gastroenterology and Hepatology, Mayo Clinic, Rochester, Minnesota, USA
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13
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Fehervari M, Fadel MG, Alghazawi LOK, Das B, Rodríguez-Luna MR, Perretta S, Wan A, Ashrafian H. Medium-Term Weight Loss and Remission of Comorbidities Following Endoscopic Sleeve Gastroplasty: a Systematic Review and Meta-analysis. Obes Surg 2023; 33:3527-3538. [PMID: 37700147 PMCID: PMC10602997 DOI: 10.1007/s11695-023-06778-x] [Citation(s) in RCA: 11] [Impact Index Per Article: 5.5] [Reference Citation Analysis] [Abstract] [Key Words] [MESH Headings] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Received: 03/07/2023] [Revised: 08/07/2023] [Accepted: 08/10/2023] [Indexed: 09/14/2023]
Abstract
This systematic review and meta-analysis aimed to determine the short- and medium-term weight loss outcomes and comorbidity resolution following endoscopic sleeve gastroplasty. Our search identified 35 relevant studies containing data from 7525 patients. Overall, pooled short-term (12 months) total weight loss (TWL) was 16.2% (95% CI 13.1-19.4%) in 23 studies (n = 5659). Pooled medium-term TWL was 15.4% (95% CI 13.7-17.2%) in 10 studies (n = 4040). Diabetes resolution was 55.4% (95% CI 46-64%), hypertension resolution was 62.8% (95% CI 43-82%), dyslipidaemia resolution was 56.3% (95% CI 49-63%), and obstructive sleep apnoea resolution was 51.7% (95% CI 16.2-87.3%) in four studies (n = 480). This pooled analysis demonstrates that ESG can induce durable weight loss and resolution of obesity-associated comorbidities in patients with moderate obesity.
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Affiliation(s)
- Matyas Fehervari
- Department of Surgery and Cancer, Imperial College London, London, UK.
- Department of Upper Gastrointestinal and Bariatric Surgery, St. George's University Hospitals NHS Foundation Trust, London, UK.
- IHU-Strasbourg, Institute of Image-Guided Surgery, Strasbourg, France.
| | - Michael G Fadel
- Department of Surgery and Cancer, Imperial College London, London, UK
| | | | - Bibek Das
- Department of Surgery and Cancer, Imperial College London, London, UK
| | - María Rita Rodríguez-Luna
- Research Institute against Digestive Cancer (IRCAD), Strasbourg, France
- ICube Laboratory, Photonics Instrumentation for Health, Strasbourg, France
| | - Silvana Perretta
- IHU-Strasbourg, Institute of Image-Guided Surgery, Strasbourg, France
- Research Institute against Digestive Cancer (IRCAD), Strasbourg, France
- Department of Digestive and Endocrine Surgery, University of Strasbourg, Strasbourg, France
| | - Andrew Wan
- Department of Upper Gastrointestinal and Bariatric Surgery, St. George's University Hospitals NHS Foundation Trust, London, UK
| | - Hutan Ashrafian
- Department of Surgery and Cancer, Imperial College London, London, UK
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14
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Zandvakili I, Pulaski M, Pickett-Blakely O. A phenotypic approach to obesity treatment. Nutr Clin Pract 2023; 38:959-975. [PMID: 37277855 DOI: 10.1002/ncp.11013] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [Key Words] [MESH Headings] [Grants] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Received: 11/30/2022] [Revised: 03/23/2023] [Accepted: 04/16/2023] [Indexed: 06/07/2023] Open
Abstract
Obesity is a chronic disease that increases morbidity and mortality and adversely affects quality of life. The rapid rise of obesity has outpaced the development and deployment of effective therapeutic interventions, thereby creating a global health crisis. The presentation, complications, and response to obesity treatments vary, yet lifestyle modification, which is the foundational therapeutic intervention for obesity, is often "one size fits all." The concept of personalized medicine uses genetic and phenotypic information as a guide for disease prevention, diagnosis, and treatment and has been successfully applied in diseases such as cancer, but not in obesity. As we gain insight into the pathophysiologic mechanisms of obesity and its phenotypic expression, specific pathways can be targeted to yield a greater, more sustained therapeutic impact in an individual patient with obesity. A phenotype-based pharmacologic treatment approach utilizing objective measures to classify patients into predominant obesity mechanism groups resulted in greater weight loss (compared with a non-phenotype-based approach) in a recent study by Acosta and colleagues. In this review, we discuss the application of lifestyle modifications, behavior therapy and pharmacotherapy using the obesity phenotype-based approach as a framework.
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Affiliation(s)
- Inuk Zandvakili
- Division of Digestive Diseases, Department of Internal Medicine, College of Medicine, University of Cincinnati, Cincinnati, Ohio, USA
- Division of Gastroenterology and Hepatology, Department of Medicine, Hospital of the University of Pennsylvania, Philadelphia, Pennsylvania, USA
| | - Marya Pulaski
- Department of Medicine, Hospital of the University of Pennsylvania, Philadelphia, Pennsylvania, USA
| | - Octavia Pickett-Blakely
- Division of Gastroenterology and Hepatology, Department of Medicine, Hospital of the University of Pennsylvania, Philadelphia, Pennsylvania, USA
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15
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Reitano E, Riva P, Keller D, Vannucci M, Zappaterra M, Vix M, Mutter D, Marescaux J, Perretta S. Deep sedation versus orotracheal intubation for endoscopic sleeve gastroplasty (ESG): preliminary experience. Surg Endosc 2023; 37:6513-6518. [PMID: 37277517 DOI: 10.1007/s00464-023-10159-x] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [Key Words] [MESH Headings] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Received: 04/01/2023] [Accepted: 05/20/2023] [Indexed: 06/07/2023]
Abstract
BACKGROUND Endoscopic sleeve gastroplasty (ESG) is an emerging bariatric procedure currently performed under general anaesthesia with orotracheal intubation (OTI). Several studies have shown the feasibility of advanced endoscopic procedures under deep sedation (DS) without impacting patient outcomes or adverse event rates. Our goal was to perform an initial comparative analysis of ESG in DS with ESG under OTI. METHODS A prospective institutional registry was reviewed for ESG patients between 12/2016 and 1/2021. Patients were stratified into OTI or DS cohorts, and the 1st 50 cases performed in each cohort were included for comparability. Univariate analysis was performed on demographics, intraoperative, and postoperative outcomes (up to 90 days). Multivariate analyses evaluated the relationship between anesthesia type, preclinical and clinical variables. RESULTS Of the 50 DS patients, 21(42%) underwent primary and 29 (58%) revisional surgery. There was no significant differences in Mallampati score across groups. No DS patient required intubation. DS patients were younger (p = 0.006) and lower BMI (p = 0.002) than OTI. As expected, DS patients overall and in the primary subgroup had shorter operative time (p ≤ 0.001 and p = 0.003, respectively) and higher rates (84% DS vs. 20% OTI, p ≤ 0.001) of ambulatory procedures. There were no significant differences in the sutures used between groups (p = 0.616). DS patients required less postoperative opioids (p ≤ 0.001) and antiemetics (p = 0.006) than OTI. There were no significant differences in 3-month postoperative weight loss across cohorts. There was no rehospitalization in either group. In primary ESG cases, we found DS patients were more likely younger (p = 0.006), female (p = 0.001), and had a lower BMI (p = 0.0027). CONCLUSIONS ESG under DS is safe and feasible in select patients. We found DS safely increased rates of outpatient care, reduced use of opioids and antiemetics, and provided the same results of postoperative weight loss. Patient selection for DS may be more clearer for durable weight loss.
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Affiliation(s)
- Elisa Reitano
- Research Institute Against Digestive Cancer (IRCAD), Strasbourg, France
- Department of General Surgery, Nouvel Hôpital Civil, CHRU-Strasbourg, Strasbourg, France
| | - Pietro Riva
- Research Institute Against Digestive Cancer (IRCAD), Strasbourg, France
- Department of General Surgery, Nouvel Hôpital Civil, CHRU-Strasbourg, Strasbourg, France
| | - Deborah Keller
- Marks Colorectal Surgical Associates, Lankenau Medical Center, Wynnewood, PA, USA
| | - Maria Vannucci
- Department of General Surgery, University of Turin, Turin, Italy
| | - Mathieu Zappaterra
- Department of General Surgery, Nouvel Hôpital Civil, CHRU-Strasbourg, Strasbourg, France
| | - Michel Vix
- Research Institute Against Digestive Cancer (IRCAD), Strasbourg, France
- Department of General Surgery, Nouvel Hôpital Civil, CHRU-Strasbourg, Strasbourg, France
| | - Didier Mutter
- Research Institute Against Digestive Cancer (IRCAD), Strasbourg, France
- Department of General Surgery, Nouvel Hôpital Civil, CHRU-Strasbourg, Strasbourg, France
| | - Jacques Marescaux
- Research Institute Against Digestive Cancer (IRCAD), Strasbourg, France
| | - Silvana Perretta
- Research Institute Against Digestive Cancer (IRCAD), Strasbourg, France.
- Department of General Surgery, Nouvel Hôpital Civil, CHRU-Strasbourg, Strasbourg, France.
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16
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Haddad JD, Almandoz JP, Gomez V, Schulman AR, Horton JD, Schellinger J, Messiah SE, Mathew MS, Marroquin EM, Tavakkoli A. Endoscopic Sleeve Gastroplasty: A Practice Pattern Survey. Obes Surg 2023; 33:2434-2442. [PMID: 37338795 PMCID: PMC11936480 DOI: 10.1007/s11695-023-06684-2] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [Key Words] [MESH Headings] [Grants] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Received: 03/20/2023] [Revised: 05/31/2023] [Accepted: 06/08/2023] [Indexed: 06/21/2023]
Abstract
PURPOSE Obesity is a complex, chronic disease that is strongly associated with complications which cost the US healthcare system billions of dollars per year. Endoscopic sleeve gastroplasty (ESG) has emerged as a safe and effective procedure for treatment of obesity, but without practice guidelines there are likely to be variations practice. We sought to describe current practice patterns amongst endoscopists who perform ESG to help define areas of focus for future research and guideline development. METHODS We conducted an anonymous cross-sectional survey to examine practice patterns related to ESG. The survey was organized in 5 sections: Endoscopic Practice, Training, and Resources; Pre-ESG Evaluation and Payment Model; Perioperative/Operative Period; Post-operative Period; and Endobariatric Practice Other Than ESG. RESULTS A variety of exclusion criteria were reported by physicians performing ESG. Most respondents (n = 21/32, 65.6%) would not perform ESG for BMI under 27, and 40.6% (n = 13/32) would not perform ESG on patients with BMI over 50. The majority of respondents (74.2%, n = 23/31) reported ESG was not covered in their region, and most reported patients covered residual costs (67.7%, n = 21/31). CONCLUSIONS We found significant variability with respect to practice setting, exclusion criteria, pre-procedural evaluation, and medication use. Without guidelines for the selection of patients or standards for pre- and post-ESG care, substantial barriers to coverage will remain, and ESG will remain limited to those who can meet out-of-pocket costs. Larger studies are needed to confirm our findings, and future research should be focused on establishing patient selection criteria and standards in practices to provide guidance for endobariatric programs.
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Affiliation(s)
- James D Haddad
- Division of Digestive and Liver Diseases, University of Texas Southwestern, Dallas, TX, USA.
| | - Jaime P Almandoz
- Division of Endocrinology, University of Texas Southwestern, Dallas, TX, USA
| | - Victoria Gomez
- Division of Gastroenterology and Hepatology, Mayo Clinic Florida, Jacksonville, FL, USA
| | - Allison R Schulman
- Division of Gastroenterology and Hepatology, University of Michigan, Ann Arbor, MI, USA
| | - Jay D Horton
- Division of Digestive and Liver Diseases, University of Texas Southwestern, Dallas, TX, USA
- Department of Internal Medicine, University of Texas Southwestern, Dallas, TX, USA
- Department of Molecular Genetics, University of Texas Southwestern, Dallas, TX, USA
| | - Jeffrey Schellinger
- Division of Endocrinology, University of Texas Southwestern, Dallas, TX, USA
| | - Sarah E Messiah
- School of Public Health, University of Texas Health Science Center, Dallas, TX, USA
| | - M Sunil Mathew
- School of Public Health, University of Texas Health Science Center, Dallas, TX, USA
| | | | - Anna Tavakkoli
- Division of Digestive and Liver Diseases, University of Texas Southwestern, Dallas, TX, USA
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17
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Shenoy A, Schulman AR. Advances in endobariatrics: past, present, and future. Gastroenterol Rep (Oxf) 2023; 11:goad043. [PMID: 37483864 PMCID: PMC10361810 DOI: 10.1093/gastro/goad043] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Figures] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Received: 05/12/2023] [Revised: 07/07/2023] [Accepted: 07/07/2023] [Indexed: 07/25/2023] Open
Abstract
The obesity epidemic in the USA and worldwide is well documented and continues to grow. Endoscopic metabolic and bariatric therapies may offer a less invasive approach than surgical intervention. This article will review advances in endobariatrics over the last several decades, addressing the past and current state of bariatric and metabolic endoscopy. Food and Drug Administration-cleared devices and interventions currently under investigation are described including gastric devices, gastric remodeling procedures, small-bowel devices, duodenal ablation, as well as procedures to address weight regain after bariatric surgery. Future studies evaluating gastric and duodenal combination therapy, adjunctive pharmacotherapy, as well as individualized precision-health algorithms are underway.
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Affiliation(s)
- Abhishek Shenoy
- Corresponding author. Division of Gastroenterology, Department of Internal Medicine, University of Michigan, 1500 E Medical Center Drive, Ann Arbor, MI 48105, USA. Tel: +1-908-3381691; Fax: +1-734-9365458;
| | - Allison R Schulman
- Division of Gastroenterology and Hepatology, University of Michigan, Michigan Medicine, Ann Arbor, MI, USA
- Department of Surgery, University of Michigan, Michigan Medicine, Ann Arbor, MI, USA
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18
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Tønnesen CJ, Hjelmesæth J, Aabakken L, Lund RS, Johnson LK, Hertel JK, Kalager M, Løberg M, Bretthauer M. A pilot study of implementation of endoscopic sleeve gastroplasty (ESG) in Norway. Scand J Gastroenterol 2023; 58:1180-1184. [PMID: 37128713 DOI: 10.1080/00365521.2023.2204389] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [Key Words] [MESH Headings] [Track Full Text] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Received: 03/09/2023] [Accepted: 04/13/2023] [Indexed: 05/03/2023]
Abstract
BACKGROUND AND AIM Bariatric surgery is the most effective treatment for obesity but is invasive and associated with serious complications. Endoscopic sleeve gastroplasty (ESG) is a less invasive weight loss procedure to reduce the stomach volume by full-thickness sutures. ESG has been adopted in many countries, but implementation at Scandinavian centres has not yet been documented. We performed a clinical pilot trial at a Norwegian centre with the primary objective to assess the feasibility of the ESG procedure. PATIENTS AND METHODS We included the first 10 patients treated with ESG at a Norwegian centre in a single-arm pilot study. The eligibility criteria were either a body mass index (BMI) of 40-49.9 kg/m2, BMI 35-39.9 kg/m2 and at least one obesity-related comorbidity, or BMI 30-34.9 kg/m2 and type 2 diabetes. Patient follow-up resembled the scheme used for bariatric surgery at the center, including dietary plans and outpatient visits. RESULTS All procedures were technically successful except for one patient who had adhesions between the stomach and anterior abdominal wall, related to a prior hernia repair, resulting in less-than-intended stomach volume reduction. Mean total body weight loss (TBWL) after 26 and 52 weeks was 12.2% (95% CI 8.1-16.2) and 9.1% (95% CI 3.3 - 15.0). One patient experienced a minor suture-induced diaphragmatic injury, which was successfully managed conservatively. CONCLUSIONS This first Scandinavian clinical trial of ESG, documenting the implementation of the procedure at a Norwegian center, demonstrated acceptable feasibility and safety, with large variations in individual weight loss during the 52-week follow-up period.
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Affiliation(s)
- Christer Julseth Tønnesen
- Clinical Effectiveness Research Group, University of Oslo, Oslo, Norway
- Clinical Effectiveness Research Group, Oslo University Hospital, Oslo, Norway
- Section of Gastroenterology, Department of Transplantation Medicine, Oslo University Hospital, Oslo, Norway
| | - Jøran Hjelmesæth
- Department of Endocrinology, Obesity and Nutrition, Vestfold Hospital Trust, Tønsberg, Norway
- Department of Endocrinology, Morbid Obesity and Preventive Medicine Institute of Clinical Medicine, University of Oslo, Norway
| | - Lars Aabakken
- Clinical Effectiveness Research Group, University of Oslo, Oslo, Norway
- Clinical Effectiveness Research Group, Oslo University Hospital, Oslo, Norway
- Section of Gastroenterology, Department of Transplantation Medicine, Oslo University Hospital, Oslo, Norway
- Institute of Clinical Medicine, University of Oslo, Norway
| | - Randi Størdal Lund
- Department of Endocrinology, Obesity and Nutrition, Vestfold Hospital Trust, Tønsberg, Norway
| | - Line Kristin Johnson
- Department of Endocrinology, Obesity and Nutrition, Vestfold Hospital Trust, Tønsberg, Norway
| | - Jens Kristoffer Hertel
- Department of Endocrinology, Obesity and Nutrition, Vestfold Hospital Trust, Tønsberg, Norway
| | - Mette Kalager
- Clinical Effectiveness Research Group, University of Oslo, Oslo, Norway
- Clinical Effectiveness Research Group, Oslo University Hospital, Oslo, Norway
| | - Magnus Løberg
- Clinical Effectiveness Research Group, University of Oslo, Oslo, Norway
- Clinical Effectiveness Research Group, Oslo University Hospital, Oslo, Norway
| | - Michael Bretthauer
- Clinical Effectiveness Research Group, University of Oslo, Oslo, Norway
- Clinical Effectiveness Research Group, Oslo University Hospital, Oslo, Norway
- Section of Gastroenterology, Department of Transplantation Medicine, Oslo University Hospital, Oslo, Norway
- Institute of Clinical Medicine, University of Tromsø, Norway
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19
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Michaelidou M, Pappachan JM, Jeeyavudeen MS. Management of diabesity: Current concepts. World J Diabetes 2023; 14:396-411. [PMID: 37122433 PMCID: PMC10130896 DOI: 10.4239/wjd.v14.i4.396] [Citation(s) in RCA: 41] [Impact Index Per Article: 20.5] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Download PDF] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Received: 12/25/2022] [Revised: 01/15/2023] [Accepted: 03/20/2023] [Indexed: 04/12/2023] Open
Abstract
The global prevalence of obesity is increasing rapidly with an exponential rise in incidence of type 2 diabetes mellitus in recent years. 'Diabesity', the term coined to show the strong interlink between obesity and diabetes, is the direct cons-equence of the obesity pandemic, and poses significant challenges in the management of the disease. Without addressing the clinical and mechanistic complications of obesity such as metabolic-associated fatty liver disease and obstructive sleep apnoea, a rational management algorithm for diabesity cannot be developed. Several classes of anti-diabetic medications including insulins, sulphonylureas, thiazolidinediones and meglitinides are associated with the risk of weight gain and may potentially worsen diabesity. Therefore, appropriate selection of antidiabetic drug regimen is crucial in the medical management of diabesity. The role of non-pharmacological measures such as dietary adjustments, exercise interventions and bariatric procedures should also be emphasised. Unfortunately, the importance of appropriate and optimal management of diabesity is often overlooked by medical professionals when achieving adequate glycemic control which results in inappropriate management of the disease and its complications. This review provides a narrative clinical update on the evidence behind the management of diabesity.
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Affiliation(s)
- Maria Michaelidou
- Department of Endocrinology and Metabolism, Lancashire Teaching Hospitals NHS Trust, Preston PR2 9HT, United Kingdom
| | - Joseph M Pappachan
- Department of Endocrinology and Metabolism, Lancashire Teaching Hospitals NHS Trust, Preston PR2 9HT, United Kingdom
- Faculty of Science, Manchester Metropolitan University, Manchester M15 6BH, United Kingdom
- Faculty of Biology, Medicine and Health, The University of Manchester, Manchester M13 9PL, United Kingdom
| | - Mohammad Sadiq Jeeyavudeen
- Department of Endocrinology & Metabolism, University Hospitals of Edinburgh, Edinburgh EH16 4SA, United Kingdom
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20
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Outcomes and Trends of Endoscopic Bariatric Therapies (EBT) Among Minority Populations. Obes Surg 2023; 33:513-522. [PMID: 36477696 DOI: 10.1007/s11695-022-06399-w] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Received: 08/07/2022] [Revised: 11/28/2022] [Accepted: 11/30/2022] [Indexed: 12/12/2022]
Abstract
INTRODUCTION Endoscopic bariatric therapies (EBT) have emerged as effective options for weight loss. While the benefits of EBT have been documented, data regarding such therapies among minority populations remains scant. We aim to investigate EBT trends and outcomes in minority populations. METHODS Data were extracted from the 2015 to 2019 Metabolic and Bariatric Surgery Accreditation and Quality Improvement Project (MBSAQIP) databases. Intragastric balloon (IGB) and endoscopic sleeve gastroplasty (ESG) cases were identified, and procedure volume assessed by year and race/ethnicity. Measures of interest included year-to-year mortality, surgical complications, and 30-day adverse outcomes. RESULTS Of 966,646 cases in the MBSAQIP databases, 5209 (0.54%) IGB and ESG cases were included. 10.7% were black, and 81.6% were female patients. Compared to white patients, black and Hispanic patients were younger (p < 0.01) with a higher body mass index (p < 0.001). Mortality (0.03% vs. 0% vs. 0%, p = 0.99), reoperation (1.1% vs. 0.8% vs. 0.6%, p = 0.30), and reintervention (3.9% vs. 3.2% vs. 2.3%, p = 0.09) rates were similar between racial/ethnic cohorts. All complications were similar between racial/ethnic cohorts, except a higher rate of venous thromboembolism, in Hispanic (1.04%, p < 0.01) compared to black (0.18%) and white (0.21%) patients. IGB and ESG were predominantly performed in white and Hispanic patients, respectively. ESG was associated with a higher leak (0.6% vs. 0.02%, p < 0.01) and venous thromboembolism (VTE) (1.0% vs. 0.12%, p < 0.01) rate. CONCLUSION While EBTs have increased annually, they are performed less in black patients. Future studies are needed to identify access barriers for black patients. They are safely performed with similar outcomes in racial/ethnic cohorts, except for a higher VTE rate in Hispanic patients.
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21
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Bhandari M, Kosta S, Reddy M, Mathur W, Neto MG, Bhandari M. Four-year outcomes for endoscopic sleeve gastroplasty from a single centre in India. J Minim Access Surg 2023; 19:101-106. [PMID: 36124467 PMCID: PMC10034804 DOI: 10.4103/jmas.jmas_3_22] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Indexed: 02/02/2023] Open
Abstract
Background Bariatric endoscopy has emerged for non-surgical treatment of obesity, providing a treatment option for weight loss and associated comorbidities. Outcomes of endoscopic sleeve gastroplasty (ESG) of 12 months have been published by our team and there is a need for longer follow-up period understanding the effects of ESG techniques. Aim This report emphasises on weight loss pattern in follow-up time points and monitors the post-procedure improvement in comorbidities with minimum 4-year follow-up of patients undergoing ESG at a single academic centre in India. Subjects and Methods This was a prospective cohort study. All procedures were performed by the same surgeon. Patients with a body mass index of >30 kg/m2 (or >27 with comorbidities) underwent ESG for treatment of obesity. Patients were systematically followed yearly after their procedure. Data collected on the primary outcome and secondary outcomes were analysed and presented. Results 612 patients (69.3% female) with a mean age of 40.70 ± 12.66 years and mean body mass index of 34.30 ± 5.05 kg/m2 underwent ESG. Out of 612 patients, follow-up rates for a 1-2-3 and 4 years were 93.1%, 90.2%, 81.7% and 81.9%, respectively. The mean percentage total body weight loss was 18.19% (95% confidence interval [CI]: 17.72-18.57) and %EWL was 49.30% (95% CI: 48.91-49.68) with 90% of participants-maintaining a percentage of total weight loss of ≥5% and 70% of patients maintaining an EWL of ≥25% at 4 years, respectively. Resolution/improvement of comorbidities was 51.2% cases of T2DM, 65.8% cases of hypertension, 73.6% cases of dyslipidaemia and 89.9% remission were in obstructive sleep apnoea. No patient required an emergency intervention, and there was no mortality or significant morbidity. Conclusions This study shows acceptable results with ESG at 4 years in our unit. Regular monitoring by a multidisciplinary nurtures weight loss, resolution or improvement of comorbidities and improvement of quality of life with low perioperative complications. There is a need for more reports with this approach to determine the amount and duration of weight loss outcome and medical intervention.
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Affiliation(s)
- Mahak Bhandari
- Department of Surgery, Sri Aurobindo Medical College and PG Institute, Indore, Madhya Pradesh, India
| | - Susmit Kosta
- Department of Central Research Lab, Sri Aurobindo Medical College and PG Institute, Indore, Madhya Pradesh, India
| | - Manoj Reddy
- Department of Surgery, Sri Aurobindo Medical College and PG Institute, Indore, Madhya Pradesh, India
| | - Winni Mathur
- Department of Surgery, Mohak Bariatrics and Robotics, Indore, Madhya Pradesh, India
| | - Manoel Galvao Neto
- Department of Surgery, Mohak Bariatrics and Robotics, Indore, Madhya Pradesh, India
| | - Mohit Bhandari
- Department of Surgery, Mohak Bariatrics and Robotics, Indore, Madhya Pradesh, India
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Kozłowska-Petriczko K, Pawlak KM, Wojciechowska K, Reiter A, Błaszczyk Ł, Szełemej J, Petriczko J, Wiechowska-Kozłowska A. The Efficacy Comparison of Endoscopic Bariatric Therapies: 6-Month Versus 12-Month Intragastric Balloon Versus Endoscopic Sleeve Gastroplasty. Obes Surg 2023; 33:498-505. [PMID: 36525237 PMCID: PMC9889469 DOI: 10.1007/s11695-022-06398-x] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [Key Words] [MESH Headings] [Track Full Text] [Figures] [Journal Information] [Subscribe] [Scholar Register] [Received: 07/25/2022] [Revised: 11/29/2022] [Accepted: 11/30/2022] [Indexed: 12/23/2022]
Abstract
INTRODUCTION Intragastric balloon (IGB) insertion and endoscopic sleeve gastroplasty (ESG) are known to be effective and safe in achieving weight loss. The aim of this study was to compare the effects of a 6-month IGB therapy, a 12-month IGB therapy, and ESG. METHODS We retrospectively analyzed the weight loss at IGB (Orbera) removal after 6 months (124 patients), at IGB (Orbera365) removal after 12 months (61 patients) and at 6 and 12 months after ESG (42 and 34 patients, respectively). Postprocedural care, including medication and diet, was the same for all procedures. RESULTS Mean TBWL in patients undergoing IGB placement for 6 and 12 months and ESG after 6 and 12 months were 15.2, 15.8, 26.5, and 28.7 kg, respectively. There was no significant difference in the mean %TBWL in patients undergoing IGB placement for 6 or for 12 months (15.3% vs. 14.7%, P = 0.7). ESG patients showed a significantly higher mean %TBWL than IGB patients after 6 months (15.3 vs. 19.8, P = 0.005) and 12 months (14.7 vs. 22.5, P < 0.001). CONCLUSION All three studied methods were effective for achieving weight loss. However, there was no significant difference between 6-month and 12-month IGB therapies outcomes. ESG appeared to be a more effective obesity treatment modality than IGB.
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Affiliation(s)
| | - K M Pawlak
- Endoscopy Unit, Department of Gastroenterology, Hospital of the Ministry of Interior and Administration, Szczecin, Poland
| | - K Wojciechowska
- Department of Internal Medicine and Gastroenterology, Pomeranian Medical University, Szczecin, Poland
| | - A Reiter
- Endoscopy Unit, Regional Health Center, Lubin, Poland
| | - Ł Błaszczyk
- Endoscopy Unit, Sonomed Medical Centre, Szczecin, Poland
| | - J Szełemej
- Endoscopy Unit, Regional Health Center, Lubin, Poland
| | - J Petriczko
- Department of Plastic, Endocrine and General Surgery, Pomeranian Medical University, Szczecin, Poland
| | - A Wiechowska-Kozłowska
- Endoscopy Unit, Department of Gastroenterology, Hospital of the Ministry of Interior and Administration, Szczecin, Poland
- Endoscopy Unit, Sonomed Medical Centre, Szczecin, Poland
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Jirapinyo P, Thompson CC. Comparison of distal primary obesity surgery endolumenal techniques for the treatment of obesity (with videos). Gastrointest Endosc 2022; 96:479-486. [PMID: 35568242 DOI: 10.1016/j.gie.2022.04.1346] [Citation(s) in RCA: 9] [Impact Index Per Article: 3.0] [Reference Citation Analysis] [Abstract] [Track Full Text] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Received: 02/18/2022] [Accepted: 04/30/2022] [Indexed: 12/11/2022]
Abstract
BACKGROUND AND AIMS Distal primary obesity surgery endolumenal (POSE) procedures involve plication of the gastric body, sparing the fundus. We aim to assess the efficacy of distal POSE procedures and to compare plication techniques (single-helix vs double-helix approaches). METHODS This is a prospective registry study of patients who underwent distal POSE procedures using 2 techniques: the single-helix plication technique, in which a single plication with serosa-to-serosa approximation is obtained with each device activation, and the double-helix plication technique, where 2 serosa-to-serosa plications with an internal mucosa-to-mucosa approximation are obtained with each device activation. RESULTS One hundred ten patients (90 women; mean age, 43 ± 13 years) underwent distal POSE procedures. Baseline body mass index was 38.2 ± 6.1 kg/m2. Technical success was 100%. An average of 21 ± 5 plications were placed per case. The gastric body was shortened by 74%. At 12 months, patients experienced 15.8% ± 8.9% total weight loss (TWL) (P < .0001), with 93% and 61% achieving at least 5% and 10% TWL, respectively. Blood pressure, insulin resistance, and liver enzymes improved. The serious adverse event rate was .9%, including a case of gastric perforation. Of 110 patients, 42 and 68 underwent distal POSE procedures using a single- or double-helix technique, respectively. The double-helix technique resulted in greater reduction in gastric volume (length reduction by 78% vs 65%, P < .0001), weight loss (20.3% ± 8.3% vs 13.4% ± 8.3% TWL, P = .005), and proportion of patients achieving 10% TWL (94.7% vs 58.3%, P = .03) than the single-helix technique. CONCLUSIONS Distal POSE techniques appear to be effective at treating obesity and its related comorbidities. The double-helix technique is associated with greater gastric volume reduction, weight loss, and response rate.
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Affiliation(s)
- Pichamol Jirapinyo
- Division of Gastroenterology, Hepatology and Endoscopy, Brigham and Women's Hospital, Boston, Massachusetts, USA; Harvard Medical School, Boston, Massachusetts, USA
| | - Christopher C Thompson
- Division of Gastroenterology, Hepatology and Endoscopy, Brigham and Women's Hospital, Boston, Massachusetts, USA; Harvard Medical School, Boston, Massachusetts, USA
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Abu Dayyeh BK, Bazerbachi F, Vargas EJ, Sharaiha RZ, Thompson CC, Thaemert BC, Teixeira AF, Chapman CG, Kumbhari V, Ujiki MB, Ahrens J, Day C, Galvao Neto M, Zundel N, Wilson EB. Endoscopic sleeve gastroplasty for treatment of class 1 and 2 obesity (MERIT): a prospective, multicentre, randomised trial. Lancet 2022; 400:441-451. [PMID: 35908555 DOI: 10.1016/s0140-6736(22)01280-6] [Citation(s) in RCA: 161] [Impact Index Per Article: 53.7] [Reference Citation Analysis] [Abstract] [MESH Headings] [Track Full Text] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Received: 06/11/2022] [Revised: 06/26/2022] [Accepted: 06/30/2022] [Indexed: 02/03/2023]
Abstract
BACKGROUND Endoscopic sleeve gastroplasty (ESG) is an endolumenal, organ-sparing therapy for obesity, with wide global adoption. We aimed to explore the efficacy and safety of ESG with lifestyle modifications compared with lifestyle modifications alone. METHODS We conducted a randomised clinical trial at nine US centres, enrolling individuals aged 21-65 years with class 1 or class 2 obesity and who agreed to comply with lifelong dietary restrictions. Participants were randomly assigned (1:1·5; with stratified permuted blocks) to ESG with lifestyle modifications (ESG group) or lifestyle modifications alone (control group), with potential retightening or crossover to ESG, respectively, at 52 weeks. Lifestyle modifications included a low-calorie diet and physical activity. Participants in the primary ESG group were followed up for 104 weeks. The primary endpoint at 52 weeks was the percentage of excess weight loss (EWL), with excess weight being that over the ideal weight for a BMI of 25 kg/m2. Secondary endpoints included change in metabolic comorbidities between the groups. We used multiple imputed intention-to-treat analyses with mixed-effects models. Our analyses were done on a per-protocol basis and a modified intention-to-treat basis. The safety population was defined as all participants who underwent ESG (both primary and crossover ESG) up to 52 weeks. FINDINGS Between Dec 20, 2017, and June 14, 2019, 209 participants were randomly assigned to ESG (n=85) or to control (n=124). At 52 weeks, the primary endpoint of mean percentage of EWL was 49·2% (SD 32·0) for the ESG group and 3·2% (18·6) for the control group (p<0·0001). Mean percentage of total bodyweight loss was 13·6% (8·0) for the ESG group and 0·8% (5·0) for the control group (p<0·0001), and 59 (77%) of 77 participants in the ESG group reached 25% or more of EWL at 52 weeks compared with 13 (12%) of 110 in the control group (p<0·0001). At 52 weeks, 41 (80%) of 51 participants in the ESG group had an improvement in one or more metabolic comorbidities, whereas six (12%) worsened, compared with the control group in which 28 (45%) of 62 participants had similar improvement, whereas 31 (50%) worsened. At 104 weeks, 41 (68%) of 60 participants in the ESG group maintained 25% or more of EWL. ESG-related serious adverse events occurred in three (2%) of 131 participants, without mortality or need for intensive care or surgery. INTERPRETATION ESG is a safe intervention that resulted in significant weight loss, maintained at 104 weeks, with important improvements in metabolic comorbidities. ESG should be considered as a synergistic weight loss intervention for patients with class 1 or class 2 obesity. This trial is registered with ClinicalTrials.gov, NCT03406975. FUNDING Apollo Endosurgery, Mayo Clinic.
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Affiliation(s)
- Barham K Abu Dayyeh
- Division of Gastroenterology and Hepatology, Mayo Clinic, Rochester, MN, USA.
| | - Fateh Bazerbachi
- CentraCare, Interventional Endoscopy Program, St Cloud Hospital, St Cloud, MN, USA
| | - Eric J Vargas
- Division of Gastroenterology and Hepatology, Mayo Clinic, Rochester, MN, USA
| | - Reem Z Sharaiha
- Division of Gastroenterology and Hepatology, Weill Cornell Medicine, New York, NY, USA
| | - Christopher C Thompson
- Division of Gastroenterology, Hepatology and Endoscopy, Brigham & Women's Hospital, Boston, MA, USA
| | | | - Andre F Teixeira
- Weight Loss and Bariatric Surgery Institute, Orlando Health, Orlando, FL, USA
| | - Christopher G Chapman
- Center for Endoscopic Research and Therapeutics, University of Chicago, Chicago, IL, USA
| | - Vivek Kumbhari
- Division of Gastroenterology and Hepatology, Mayo Clinic, Jacksonville, FL, USA
| | - Michael B Ujiki
- Department of Surgery, NorthShore University Health System, Chicago, IL, USA
| | | | - Courtney Day
- Division of Clinical Trials and Biostatistics, Mayo Clinic, Rochester, MN, USA
| | - Manoel Galvao Neto
- Division of Gastrointestinal Endoscopy, ABC Medical School, São Paulo, Brazil
| | - Natan Zundel
- Department of Surgery, State University of New York, Buffalo, NY, USA
| | - Erik B Wilson
- Department of Surgery, The University of Texas Health Science Center, Houston, TX, USA
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Brunaldi VO, Stier C. ESG should be judged on its own merits. Lancet 2022; 400:410-411. [PMID: 35908556 DOI: 10.1016/s0140-6736(22)01380-0] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Track Full Text] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Received: 06/30/2022] [Accepted: 07/14/2022] [Indexed: 11/24/2022]
Affiliation(s)
- Vitor Ottoboni Brunaldi
- Gastrointestinal Endoscopy Unit, Gastroenterology Department, University of São Paulo Medical School, São Paulo, Brazil; Center for Digestive Endoscopy, Surgery and Anatomy Department, Ribeirão Preto Medical School, University of São Paulo, Ribeirão Preto 14040, Brazil.
| | - Christine Stier
- Department of Internal Medicine, Division of Endocrinology and Diabetology, and Department of General, Visceral, Transplant, Vascular, and Pediatric Surgery, University Hospital Würzburg, Würzburg, Germany; Department of Surgical Endoscopy, Sana Hospital Huerth, Huerth, Germany
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Outcomes of Endoscopic Sleeve Gastroplasty in the Elder Population. Obes Surg 2022; 32:3390-3397. [PMID: 35918595 PMCID: PMC9532333 DOI: 10.1007/s11695-022-06232-4] [Citation(s) in RCA: 9] [Impact Index Per Article: 3.0] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Download PDF] [Figures] [Journal Information] [Subscribe] [Scholar Register] [Received: 06/03/2022] [Revised: 07/25/2022] [Accepted: 07/26/2022] [Indexed: 11/14/2022]
Abstract
Purpose With the aging of the population and the epidemic spread of obesity, the frequency of older individuals with obesity is steadily growing. To date, no data evaluating the use of endoscopic sleeve gastroplasty (ESG) in the elderly have been published. In this case series, we evaluate the short- and medium-term outcomes of ESG in patients with obesity aged 65 years and older. Materials and Methods A retrospective analysis was done on a prospective database; patients aged 65 years and older were included in our analysis. EWL%, TBWL%, the Bariatric Analysis and Reporting Outcome System (BAROS) questionnaire, and the presence of comorbidities were assessed. Results Eighteen patients aged 65 years and older underwent ESG between November 2017 and July 2021. The median age was 67 years and the mean baseline BMI was 41.2 kg/m2. After ESG, the median TBWL% was 15.1%, 15.5%, and 15.5% at 6, 12, and 24 months, while the median %EWL was 39%, 37%, and 41% at 6, 12, and 24 months, respectively. The median BAROS score was 3.0, 3.4, and 2.5 at 6, 12, and 24 months, respectively. Six out of twelve patients with hypertension and 3/4 diabetic patients reduced or removed their medications within 12 months following ESG. Two out of six patients with OSA stopped therapy with CPAP. No adverse events were recorded. Conclusion According to our experience, ESG is a promising therapeutic option for elder individuals with obesity who fail non-invasive methods, and who refuse or are deemed not suitable for bariatric surgery because of age and comorbidities. Graphical abstract ![]()
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Safety of Endoscopic Sleeve Gastroplasty with a Single-Channel Endoscope. Obes Surg 2022; 32:3074-3078. [PMID: 35857182 DOI: 10.1007/s11695-022-06210-w] [Citation(s) in RCA: 4] [Impact Index Per Article: 1.3] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Received: 04/02/2022] [Revised: 07/10/2022] [Accepted: 07/14/2022] [Indexed: 02/07/2023]
Abstract
PURPOSE Less invasive endoscopic bariatric procedures are under development for the management of class I of obesity. The purpose of our study is to evaluate the safety of endoscopic sleeve gastroplasty (ESG) using the new suturing device OverStitch Sx™. MATERIALS AND METHODS This is a retrospective single-center study over 191 patients using the ESG under general anesthesia with overnight inpatient observation between January 2019 and December 2020. The analyzed variables were adverse effects and change in body weight at 6 and 12 months of follow-up. RESULTS A total of 191 patients underwent ESG for primary obesity. There were 173 female (90.6%) with a mean age of 36.9 years. The mean BMI was 33.7 kg/m2 (range: 28.9-54). There were no major intra-procedure adverse events. There were two postprocedural complications (1.04%), a transparietal suturing of falciform ligament which needed laparoscopic exploration for severe abdominal pain and a perigastric collection with antibiotic treatment, both with favorable outcome. Considering the weight loss results, the %TWL recorded was 22.4% for 84 patients (43.9%, 6 months' follow-up) and 18.7% for 69 patients (36.1%, 12 months' follow-up) with the mean EWL of 41.6% and respectively 34.7%. A total of 59 patients (30.9%) were lost follow-up and 12 patients underwent revisional bariatric procedure. According to ASGE definition, 53.8% (n = 71) reached > 25% of EWL. CONCLUSION Endoscopic gastroplasty represents a safe minimal invasive approach with the new device OverStitch Sx™ that can be considered an effective and well-tolerated procedure especially for primary obesity treatment.
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Dials J, Demirel D, Halic T, De S, Ryason A, Kundumadam S, Al-Haddad M, Gromski MA. Hierarchical task analysis of endoscopic sleeve gastroplasty. Surg Endosc 2022; 36:5167-5182. [PMID: 34845547 PMCID: PMC9148380 DOI: 10.1007/s00464-021-08893-1] [Citation(s) in RCA: 4] [Impact Index Per Article: 1.3] [Reference Citation Analysis] [Abstract] [Key Words] [MESH Headings] [Grants] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Received: 03/29/2021] [Accepted: 11/16/2021] [Indexed: 11/30/2022]
Abstract
BACKGROUND Endoscopic sleeve gastroplasty (ESG) is a minimally invasive endoscopic weight loss procedure used to treat obesity. The long-term goal of this project is to develop a Virtual Bariatric Endoscopy (ViBE) simulator for training and assessment of the ESG procedure. The objectives of this current work are to: (a) perform a task analysis of ESG and (b) create metrics to be validated in the created simulator. METHODS We performed a hierarchical task analysis (HTA) by identifying the significant tasks of the ESG procedure. We created the HTA to show the breakdown and connection of the tasks of the procedure. Utilizing the HTA and input from ESG experts, performance metrics were derived for objective measurement of the ESG procedure. Three blinded video raters analyzed seven recorded ESG procedures according to the proposed performance metrics. RESULTS Based on the seven videos, there was a positive correlation between total task times and total performance scores (R = 0.886, P = 0.008). Endoscopists expert were found to be more skilled in reducing the area of the stomach compared to endoscopists novice (34.6% reduction versus 9.4% reduction, P = 0.01). The mean novice performance score was significantly lower than the mean expert performance score (34.7 vs. 23.8, P = 0.047). The inter-rater reliability test showed a perfect agreement among three raters for all tasks except for the suturing task. The suturing task had a significant agreement (Inter-rater Correlation = 0.84, Cronbach's alpha = 0.88). Suturing was determined to be a critical task that is positively correlated with the total score (R = 0.962, P = 0.0005). CONCLUSION The task analysis and metrics development are critical for the development of the ViBE simulator. This preliminary assessment demonstrates that the performance metrics provide an accurate assessment of the endoscopist's performance. Further validation testing and refinement of the performance metrics are anticipated.
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Affiliation(s)
- James Dials
- Department of Computer Science, Florida Polytechnic University, 4700 Research Way, Lakeland, FL, 33805, USA
| | - Doga Demirel
- Department of Computer Science, Florida Polytechnic University, 4700 Research Way, Lakeland, FL, 33805, USA.
| | - Tansel Halic
- Department of Computer Science, University of Central Arkansas, Conway, USA
| | - Suvranu De
- Department of Mechanical, Aerospace and Nuclear Engineering, Rensselear Polytechnic Institute, Troy, USA
| | - Adam Ryason
- Department of Mechanical, Aerospace and Nuclear Engineering, Rensselear Polytechnic Institute, Troy, USA
| | - Shanker Kundumadam
- Division of Gastroenterology and Hepatology, Indiana University School of Medicine, Indianapolis, USA
| | - Mohammad Al-Haddad
- Division of Gastroenterology and Hepatology, Indiana University School of Medicine, Indianapolis, USA
| | - Mark A Gromski
- Division of Gastroenterology and Hepatology, Indiana University School of Medicine, Indianapolis, USA
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Sarkar A, Tawadros A, Andalib I, Shahid HM, Tyberg A, Alkhiari R, Gaidhane M, Kedia P, John ES, Bushe B, Martinez GM, Zamarripa F, Carames MC, Carames JC, Casarodriguez F, Bove V, Costamagna G, Boskoski I, Kahaleh M. Safety and efficacy of endoscopic sleeve gastroplasty for obesity management in new bariatric endoscopy programs: a multicenter international study. Ther Adv Gastrointest Endosc 2022; 15:26317745221093883. [PMID: 35694412 PMCID: PMC9178997 DOI: 10.1177/26317745221093883] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [Track Full Text] [Download PDF] [Figures] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Received: 01/21/2021] [Accepted: 03/21/2022] [Indexed: 11/17/2022] Open
Abstract
Background: Endoscopic sleeve gastroplasty (ESG) is an incisionless procedure that reduces the size of the gastric cavity. In prior studies, it has been proven to be a safe and effective treatment for obesity. In this study, we performed a collaborative study to evaluate the effectiveness of ESG among new endobariatric programs. Methods: This was an international, multicenter study reviewing the outcomes of ESG in centers starting ESG programs. Total body weight loss, change of body mass index (BMI), excess body weight loss (EBWL), technical success, duration of hospitalization, and immediate and delayed adverse events and complications at 24 h, 1 week, and 1, 3, and 6 months post-procedure were evaluated. Results: A total of 91 patients (35 males) from six centers were included. The patients’ mean BMI before the procedure was 38.7 kg/m2. BMI reduction at 3 months was 7.3 (p < 0.000), at 6 months 9.3 (p < 0.000), and at 12 months 8.6 (p < 0.000) from baseline. EBWL was 17.3% at 1 month (p < 0.000), 29.2% at 3 months (p < 0.000), and 35.6% at 6 months (p < 0.000). The mean procedure duration was 85.1 min. The mean length of hospital stay post-procedure was 27 h. Conclusion: ESG provides EBWL percentage sustained up to 12 months. These results are equivalent among the new ESG centers compared to previous studies by expert centers. Lay title Endoscopic sleeve gastroplasty in new bariatric endoscopy programs: Plain Language Summary This article is the result of a collaborative international study on new endoscopic programs offering endoscopic sleeve gastroplasty. The minimally invasiveness and increasing accessibility of this technique makes it very attractive for patients with obesity while being poor candidate for surgery or refusing surgery. This study will also provide valuable information regarding this rising technique of endobariatric treatment.
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Affiliation(s)
- Avik Sarkar
- Gastroenterology, Rutgers Robert Wood Johnson Medical School, New Brunswick, NJ, USA
| | - Augustine Tawadros
- Gastroenterology, Rutgers Robert Wood Johnson Medical School, New Brunswick, NJ, USA
| | - Iman Andalib
- Gastroenterology, Rutgers Robert Wood Johnson Medical School, New Brunswick, NJ, USA
| | - Haroon M. Shahid
- Gastroenterology, Rutgers Robert Wood Johnson Medical School, New Brunswick, NJ, USA
| | - Amy Tyberg
- Gastroenterology, Rutgers Robert Wood Johnson Medical School, New Brunswick, NJ, USA
| | - Resheed Alkhiari
- Gastroenterology, Rutgers Robert Wood Johnson Medical School, New Brunswick, NJ, USA
| | - Monica Gaidhane
- Gastroenterology, Rutgers Robert Wood Johnson Medical School, New Brunswick, NJ, USA
| | | | | | - Bryce Bushe
- Gastroenterology, Methodist Hospital, Dallas, TX, USA
| | | | | | | | | | | | - Vincenzo Bove
- Gastroenterology, Fondazione Policlinico A. Gemelli, Roma, Italy
| | - Guido Costamagna
- Gastroenterology, Fondazione Policlinico A. Gemelli, Roma, Italy
| | - Ivo Boskoski
- Gastroenterology, Fondazione Policlinico A. Gemelli, Roma, Italy
| | - Michel Kahaleh
- Department of Gastroenterology, Robert Wood Johnson University Hospital, New Brunswick, NJ 08901, USA
- Gastroenterology, Rutgers Robert Wood Johnson Medical School, New Brunswick, NJ, USA
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Primary Bariatric Procedures. Dig Dis Sci 2022; 67:1674-1687. [PMID: 35348970 DOI: 10.1007/s10620-022-07393-z] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Accepted: 01/04/2022] [Indexed: 12/09/2022]
Abstract
Obesity is pandemic. It is estimated that by 2030, half of the U.S. population will have obesity. Current treatment options for obesity includes lifestyle modification, pharmacotherapy, endoscopic bariatric and metabolic therapy (EBMT) and bariatric surgery. Over the past decades, an increasing number of EBMTs have been developed and become available. As a gastroenterologist, it is therefore important to become familiar with the available EBMTs as well as their safety and efficacy profiles in order to educate and expeditiously refer patients for the appropriate therapy when eligible. This chapter will review currently available and upcoming EBMTs. Details on how the procedures are performed, their mechanisms of action as well as data from pivotal studies will be summarized.
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Reja D, Zhang C, Sarkar A. Endoscopic bariatrics: current therapies and future directions. Transl Gastroenterol Hepatol 2022; 7:21. [PMID: 35548475 PMCID: PMC9081914 DOI: 10.21037/tgh.2020.03.09] [Citation(s) in RCA: 6] [Impact Index Per Article: 2.0] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Received: 11/14/2019] [Accepted: 03/23/2020] [Indexed: 10/27/2023] Open
Abstract
Endoscopic bariatric therapies (EBTs) are endoscopic procedures indicated for weight loss in the obese population. They are shown to be safe and effective for patients who do not quality for bariatric surgery. There are currently no randomized controlled studies comparing bariatric surgery with EBTs. However, EBTs are more cost effective and have fewer complications. This review will examine currently available EBTs with published data.
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Affiliation(s)
- Debashis Reja
- Division of Internal Medicine, Department of Medicine, Robert Wood Johnson Medical Center, New Brunswick, New Jersey, USA
| | - Clark Zhang
- Division of Internal Medicine, Department of Medicine, Robert Wood Johnson Medical Center, New Brunswick, New Jersey, USA
| | - Avik Sarkar
- Division of Gastroenterology, Department of Medicine, Robert Wood Johnson Medical Center, New Brunswick, New Jersey, USA
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Espinet-Coll E, Díaz-Galán P, Nebreda-Durán J, Gómez-Valero JA, Vila-Lolo C, Bautista-Altamirano C, Bargalló-García A, Galvao-Neto M, Muñoz-Navas M, Bargalló-Carulla D. Persistence of Sutures and Gastric Reduction After Endoscopic Sleeve Gastroplasty: Radiological and Endoscopic Assessment. Obes Surg 2022; 32:1969-1979. [PMID: 35353330 DOI: 10.1007/s11695-022-06039-3] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Received: 12/15/2021] [Revised: 03/19/2022] [Accepted: 03/22/2022] [Indexed: 10/18/2022]
Abstract
BACKGROUND Endoscopic sleeve gastroplasty (ESG) is an effective medium-term procedure for obesity treatment. There are no consistent studies confirming persistence of maintained gastric tubular configuration. We determined sleeve duration, gastric reduction degree, and suture persistence at 12-month follow-up. PATIENTS AND METHODS This is a prospective, single-center study, including patients with obesity undergoing ESG with at least 1-year follow-up, who underwent the following: (1) Barium X-ray study (BS) prior and at 6 months, assessing degree of gastric reduction (severe, moderate, or mild), and (2) gastroscopy at 12 months, accounting the number of persistent sutures (tense, lax, or absent). Secondary outcomes were weight loss data and procedure safety profile. RESULTS Thirty-eight patients (30 women), median age of 47.0 [40.0-51.0] years, and average baseline BMI of 37.6 [35.5-41.5] kg/m2 were included. Median %TWL of 17.1% [16.1-22.3%] with TWL > 10% in 94.7% of patients was obtained at 1 year. No major AEs were observed. Six months BS was performed on 30 patients: 12 (40.0%), 14 (46.7%), and 4 (13.3%) patients showed severe, moderate, and mild gastric reduction, respectively. Twelve months gastroscopy was performed on 22 patients with 83.64% of sutures persisting (92 of 110, mean 4.2 of 5.0 sutures/patient) and 70.9% with adequate tension. We found intact sutures in 12 patients (54.5%), and 10 patients (45.5%) had some suture detached (average 1.8, r = 1-3). There were no differences in %TWL according to BS reduction (p = 0.662) or number of persistent sutures (p = 0.678). CONCLUSIONS ESG is an effective and safe weight loss strategy at 12-month follow-up with persistence of most sutures and maintenance of notable gastric reduction and remodeling.
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Affiliation(s)
- Eduard Espinet-Coll
- Bariatric Endoscopy Unit, Dexeus University Hospital and Diagonal Clinic, Sabino de Arana, 5-15, 08028, Barcelona, Spain.
| | - Patricia Díaz-Galán
- Bariatric Endoscopy Unit, Dexeus University Hospital and Diagonal Clinic, Sabino de Arana, 5-15, 08028, Barcelona, Spain
| | - Javier Nebreda-Durán
- Bariatric Endoscopy Unit, Dexeus University Hospital and Diagonal Clinic, Sabino de Arana, 5-15, 08028, Barcelona, Spain
| | - José A Gómez-Valero
- Bariatric Endoscopy Unit, Dexeus University Hospital and Diagonal Clinic, Sabino de Arana, 5-15, 08028, Barcelona, Spain
| | - Carmen Vila-Lolo
- Bariatric Endoscopy Unit, Dexeus University Hospital and Diagonal Clinic, Sabino de Arana, 5-15, 08028, Barcelona, Spain
| | | | - Ana Bargalló-García
- Bariatric Endoscopy Unit, Dexeus University Hospital and Diagonal Clinic, Sabino de Arana, 5-15, 08028, Barcelona, Spain
| | | | - Miguel Muñoz-Navas
- Bariatric Endoscopy Unit, Dexeus University Hospital and Diagonal Clinic, Sabino de Arana, 5-15, 08028, Barcelona, Spain
| | - Domingo Bargalló-Carulla
- Bariatric Endoscopy Unit, Dexeus University Hospital and Diagonal Clinic, Sabino de Arana, 5-15, 08028, Barcelona, Spain
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Abstract
Since its first description in 2013, robust evidence supporting the efficacy and safety of the endoscopic sleeve gastroplasty (ESG) has been on the rise. A large case series and meta-analysis report supported results up to 24 months, while some other studies already described 5-year data. If associated with pharmacotherapy, the ESG may help one to achieve weight loss similar to that of surgical sleeve gastrectomy. Though the results of the ongoing randomized trials on ESG are awaited, currently available data support the clinical use of the ESG, especially for patients who are refusing or unfit for bariatric surgery.
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Carr P, Keighley T, Petocz P, Blumfield M, Rich GG, Cohen F, Soni A, Maimone IR, Fayet-Moore F, Isenring E, Marshall S. Efficacy and safety of endoscopic sleeve gastroplasty and laparoscopic sleeve gastrectomy with 12+ months of adjuvant multidisciplinary support. BMC PRIMARY CARE 2022; 23:26. [PMID: 35123409 PMCID: PMC8817771 DOI: 10.1186/s12875-022-01629-7] [Citation(s) in RCA: 22] [Impact Index Per Article: 7.3] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Download PDF] [Figures] [Subscribe] [Scholar Register] [Received: 06/03/2021] [Accepted: 01/19/2022] [Indexed: 02/07/2023]
Abstract
Background The laparoscopic sleeve gastrectomy (LSG) and the incisionless endoscopic sleeve gastroplasty (ESG) weight loss procedures require further investigation of their efficacy, safety and patient-centered outcomes in the Australian setting. Methods The aim was to examine the 6- and 12-month weight loss efficacy, safety, and weight-related quality of life (QoL) of adults with obesity who received the ESG or LSG bariatric procedure with 12+ months of adjuvant multidisciplinary pre- and postprocedural support. Data were from a two-arm prospective cohort study that followed patients from baseline to 12-months postprocedure from a medical center in Queensland. Percent excess weight loss (%EWL) was the primary outcome. Secondary outcomes were body composition (fat mass, fat-free mass, android:gynoid ratio, bone mineral content) via dual energy X-ray absorptiometry, weight-related QoL, lipid, glycemic, and hepatic biochemistry, and adverse events. Results 16 ESG (19% attrition; 81.2% female; aged:41.4 (SD: 10.4) years; BMI: 35.5 (SD: 5.2) kg/m2) and 45 LSG (9% attrition; 84.4% female; aged:40.4 (SD: 9.0) years; BMI: 40.7 (SD: 5.6) kg/m2) participants were recruited. At 12-months postprocedure, ESG %EWL was 57% (SD: 32%; p < 0.01) and LSG %EWL was 79% (SD: 24%; p < 0.001). ESG and LSG cohorts improved QoL (19.8% in ESG [p > 0.05]; 48.1% in LSG [p < 0.05]), liver function (AST: − 4.4 U/L in ESG [p < 0.05]; − 2.7 U/L in LSG [p < 0.05]), HbA1c (− 0.5% in ESG [p < 0.05]; − 0.1% in LSG [p < 0.05]) and triglycerides (− 0.6 mmol/L in ESG [p > 0.05]; − 0.4 mmol/L in LSG [P < 0.05]) at 12-months. Both cohorts reduced fat mass (p < 0.05). The ESG maintained but LSG decreased fat-free mass at 6-months (p < 0.05); and both cohorts lost fat-free mass at 12-months (p < 0.05). There were no adverse events directly related to the procedure. The ESG reported 25% mild-moderate adverse events possibly related to the procedure, and the LSG reported 27% mild-severe adverse events possibly related to the procedure. Conclusions In this setting, the ESG and LSG were safe and effective weight loss treatments for obese adults alongside multidisciplinary support. Patients who elected the ESG maintained fat-free mass at 6-months but both cohorts lost fat-free mass at 12-months postprocedure. Patients who elected the LSG had large and significant improvements to weight-related quality of life. Further well-powered studies are required to confirm these findings. Trial registration This study was registered prospectively at the Australia New Zealand Clinical Trials Registry on 06/03/2018, Registration Number ACTRN12618000337279. Supplementary Information The online version contains supplementary material available at 10.1186/s12875-022-01629-7.
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Affiliation(s)
- Prudence Carr
- Department of Science, Nutrition Research Australia, Level 10, 20 Martin Place, Sydney, New South, Wales
| | - Tim Keighley
- Department of Science, Nutrition Research Australia, Level 10, 20 Martin Place, Sydney, New South, Wales
| | - Peter Petocz
- Department of Science, Nutrition Research Australia, Level 10, 20 Martin Place, Sydney, New South, Wales
| | - Michelle Blumfield
- Department of Science, Nutrition Research Australia, Level 10, 20 Martin Place, Sydney, New South, Wales
| | - Graeme G Rich
- Bariatric Gastroenterologist & Director, Bariatrics Australia, Sydney Adventist Hospital, Wahroonga, Australia
| | - Felicity Cohen
- Weightloss Solutions Australia, Varsity Lakes, Queensland, Australia
| | - Asha Soni
- Weightloss Solutions Australia, Varsity Lakes, Queensland, Australia
| | | | - Flavia Fayet-Moore
- Nutrition Research Australia, Level 10, 20 Martin Place, Sydney, New South, Wales
| | - Elizabeth Isenring
- Bond University Nutrition & Dietetics Research Group, Faculty of Health Sciences and Medicine, Bond University, Robina, Queensland, Australia
| | - Skye Marshall
- Department of Science, Nutrition Research Australia, Level 10, 20 Martin Place, Sydney, New South, Wales. .,Bond University Nutrition & Dietetics Research Group, Faculty of Health Sciences and Medicine, Bond University, Robina, Queensland, Australia.
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Review about Psychological Barriers to Lifestyle Modification, Changes in Diet Habits, and Health-Related Quality of Life in Bariatric Endoscopy. Nutrients 2022; 14:nu14030595. [PMID: 35276953 PMCID: PMC8840117 DOI: 10.3390/nu14030595] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [Track Full Text] [Download PDF] [Figures] [Journal Information] [Subscribe] [Scholar Register] [Received: 12/17/2021] [Revised: 01/24/2022] [Accepted: 01/25/2022] [Indexed: 12/10/2022] Open
Abstract
Obesity is an expanding disease responsible for significant deterioration in the Health-Related Quality of Life (HRQL) of those who suffer from it. Bariatric Endoscopy (BE) therapies have proven to be an effective treatment for this pathology. A multidisciplinary approach is essential for the successful therapeutic management of BE. This article addresses the multidisciplinary treatment of BE by considering the possible variables that can influence treatment. In particular, the variables that can facilitate or hinder changes in patients’ habits are discussed. These include the neuropsychological, emotional, and social implications that may influence the formation of healthy habits necessary for improvement in a patient’s quality of life; the individual and environmental psychological factors that influence the monitoring of nutritional and physical activity indications; and different psychological disorders such as depression, anxiety, or disorders related to eating. The main objective of BE treatment, except in certain special biological situations, must be to establish a long-term sustainable change in habits such that patients, once they reach a healthy weight, do not revert to the lifestyle that caused their obesity, as well as identifying and addressing major problems that may exist prior to, or arise during, treatment.
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Keihanian T, Othman MO. OverStitch Sx Endoscopic suturing system in minimally invasive endoscopic procedures: overview of its safety and efficacy and comparison to oversticth TM. Expert Rev Med Devices 2021; 19:11-23. [PMID: 34913782 DOI: 10.1080/17434440.2022.2019579] [Citation(s) in RCA: 9] [Impact Index Per Article: 2.3] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Indexed: 10/19/2022]
Abstract
INTRODUCTION OverStitch endoscopic suturing enables advanced closure by tissue approximation via endoscopically placed sutures with the ability to customize suture patterns. Newer OverStitch generation also known as OverStitch Sx overcame the limitation of the previous generation and is compatible with 20 single channel scopes over four platforms with greater maneuverability and visibility. AREAS COVERED In this article we will focus on the differences between three generations of OverStitch. In addition, we will review existing literature on the efficacy of OverStitch in the management of full thickness defect closure, fistula and leaks repair, stent fixation, and bariatric surgeries along with its complications and limitations. EXPERT OPINION Assembling overstitch takes less than five minutes and the correct sequence of system assembly is the key for a successful procedure. Transition from the second-generation OverStitch to OverStitch Sx may require three to five cases for learning curve.
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Affiliation(s)
- Tara Keihanian
- Division of Gastroenterology, University of Miami Miller School of Medicine, Miami, FL, USA
| | - Mohamed O Othman
- Gastroenterology and Hepatology Section, Baylor St Luke's Medical Center, Baylor College of Medicine, Houston, TX, USA
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Personalized Approach for Obese Patients Undergoing Endoscopic Sleeve Gastroplasty. J Pers Med 2021; 11:jpm11121298. [PMID: 34945770 PMCID: PMC8704248 DOI: 10.3390/jpm11121298] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Download PDF] [Figures] [Journal Information] [Subscribe] [Scholar Register] [Received: 09/15/2021] [Revised: 11/12/2021] [Accepted: 11/17/2021] [Indexed: 12/03/2022] Open
Abstract
Obesity is a chronic, relapsing disease representing a major global health problem in the 21st century. Several etiologic factors are involved in its pathogenesis, including a Western hypercaloric diet, sedentariness, metabolic imbalances, genetics, and gut microbiota modification. Lifestyle modifications and drugs often fail to obtain an adequate and sustained weight loss. To date, bariatric surgery (BS) is the most effective treatment, but only about 1% of eligible patients undergo BS, partly because of its negligible morbidity and mortality. Endoscopic sleeve gastroplasty (ESG) is a minimally invasive, endoscopic, bariatric procedure, which proved to be safe and effective. In this review, we aim to examine evidence supporting the role of a personalized and multidisciplinary approach, guided by a multidisciplinary team (MDT), for obese patients undergoing ESG, from patient selection to long-term follow-up. The cooperation of different health professionals, including an endocrinologist and/or obesity medicine physician, a bariatric surgeon, an endoscopist experienced in bariatrics, a registered dietitian, an exercise specialist, a behaviour coach, a psychologist, and a nurse or physician extender, aims to induce radical and sustained lifestyle changes. We also discussed the relationship between gut microbiota and outcomes after bariatric procedures, speculating that the characterization of gut microbiota before and after ESG may help develop new tools, including probiotics, to optimize weight loss outcomes.
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38
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Rudiman R. Advances in gastrointestinal surgical endoscopy. Ann Med Surg (Lond) 2021; 72:103041. [PMID: 34888040 PMCID: PMC8636781 DOI: 10.1016/j.amsu.2021.103041] [Citation(s) in RCA: 3] [Impact Index Per Article: 0.8] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Download PDF] [Figures] [Journal Information] [Subscribe] [Scholar Register] [Received: 10/06/2021] [Revised: 11/06/2021] [Accepted: 11/09/2021] [Indexed: 11/22/2022] Open
Abstract
Surgeons have a role in observing, detect abnormalities, disease, and other deficiencies in function which could be treated. Diagnosing and treating back days were challenging for many reasons. However, technology's innovation enhances surgeons' ability to treat their patients. The term endoscopy refers to the Greek prefix endo- ("within") and the verb skopein ("to view or observe"). Endoscopy is practical both in the diagnosis and treatment of various pathologies. Technological advances, especially in endoscopy, gradually progress and discover many possibilities which allow rapid advancement. Endoscopy development aims to assess human orifice that has not been inspected, probed, and examined over the centuries. Endoscopy over these decades is improving, which led to new problem solving using advanced technological approaches. Thus, a surgeon can solve any issues from examination, diagnosis, and treatment using progressive endoscopy evolution. This review delivers a brief history of advances in surgical endoscopy and describes current endoscopy development.
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Affiliation(s)
- Reno Rudiman
- Division of Digestive Surgery, Department of General Surgery, School of Medicine, Padjadjaran University, Hasan Sadikin General Hospital, Bandung, Indonesia
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39
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Wang Y, Kassab GS. Efficacy and Mechanisms of Gastric Volume-Restriction Bariatric Devices. Front Physiol 2021; 12:761481. [PMID: 34777019 PMCID: PMC8585502 DOI: 10.3389/fphys.2021.761481] [Citation(s) in RCA: 4] [Impact Index Per Article: 1.0] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Download PDF] [Figures] [Journal Information] [Subscribe] [Scholar Register] [Received: 08/19/2021] [Accepted: 10/07/2021] [Indexed: 12/27/2022] Open
Abstract
Obesity is a chronic disease that affects over 795 million people worldwide. Bariatric surgery is an effective therapy to combat the epidemic of clinically severe obesity, but it is only performed in a very small proportion of patients because of the limited surgical indications, the irreversibility of the procedure, and the potential postoperative complications. As an alternative to bariatric surgery, numerous medical devices have been developed for the treatment of morbid obesity and obesity-related disorders. Most devices target restriction of the stomach, but the mechanism of action is likely more than just mechanical restriction. The objective of this review is to integrate the underlying mechanisms of gastric restrictive bariatric devices in obesity and comorbidities. We call attention to the need for future studies on potential mechanisms to shed light on how current gastric volume-restriction bariatric devices function and how future devices and treatments can be further improved to combat the epidemic of obesity.
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Affiliation(s)
- Yanmin Wang
- California Medical Innovations Institute, San Diego, CA, United States
| | - Ghassan S Kassab
- California Medical Innovations Institute, San Diego, CA, United States
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40
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Abstract
The field of endoscopic bariatric and metabolic therapy has rapidly evolved from offering endoscopic treatment of weight regain following bariatric surgery to providing primary weight loss options as alternatives to pharmacologic and surgical interventions. Gastric devices and remodeling procedures were initially designed to work through a mechanism of volume restriction, leading to earlier satiety and reduced caloric intake. As the field continues to grow, small bowel interventions are evolving that may have some effect on weight loss but focus on the treatment of obesity-related comorbidities. Future implementation of combination therapy that utilizes both gastric and small bowel interventions offers an exciting option to further augment weight loss and alleviate metabolic disease. This review considers gastric devices and techniques including space-occupying intragastric balloons, aspiration therapy, endoscopic tissue suturing, and plication interventions, followed by a review of small bowel interventions including endoluminal bypass liners, duodenal mucosal resurfacing, and endoscopically delivered devices to create incisionless anastomoses. Expected final online publication date for the Annual Review of Medicine, Volume 73 is January 2022. Please see http://www.annualreviews.org/page/journal/pubdates for revised estimates.
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Affiliation(s)
- Russell D Dolan
- Division of Gastroenterology, Hepatology and Endoscopy, Brigham and Women's Hospital, Boston, Massachusetts 02115, USA;
| | - Allison R Schulman
- Division of Gastroenterology and Hepatology, University of Michigan, Ann Arbor, Michigan 48109, USA; .,Department of Surgery, University of Michigan, Ann Arbor, Michigan 48109, USA
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Staudenmann DA, Sui Z, Saxena P, Kaffes AJ, Marinos G, Kumbhari V, Aepli P, Sartoretto A. Endoscopic bariatric therapies for obesity: a review. Med J Aust 2021; 215:183-188. [PMID: 34333788 DOI: 10.5694/mja2.51179] [Citation(s) in RCA: 8] [Impact Index Per Article: 2.0] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Indexed: 12/24/2022]
Abstract
▪ Obesity is reaching pandemic proportions globally, with overweight or obesity affecting at least two-thirds of Australian adults. ▪ Bariatric surgery is an effective weight loss strategy but is constrained by high resource requirements and low patient acceptance. ▪ Multiple endoscopic bariatric therapies have matured, with well established and favourable safety and efficacy profiles in multiple randomised controlled trials (RCTs), and are best used within a multidisciplinary setting as an adjuvant to lifestyle intervention. ▪ Three types of intragastric balloon are currently in use in Australia offering average total weight loss ranging from 10% to 18%, with others available internationally. ▪ Endoscopic sleeve gastroplasty produces average total weight loss of 15-20% with low rates of severe complications, with RCT data anticipated in December 2021. ▪Bariatric and metabolic endoscopy is rapidly evolving, with many novel, promising therapies currently under investigation.
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Affiliation(s)
- Dominic A Staudenmann
- AW Morrow Gastroenterology and Liver Centre, Royal Prince Alfred Hospital, Sydney, NSW.,Praxis Balsiger Seibold und Partner, Bern, Switzerland.,Université de Fribourg, Fribourg, Switzerland
| | | | | | - Arthur J Kaffes
- AW Morrow Gastroenterology and Liver Centre, Royal Prince Alfred Hospital, Sydney, NSW
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Grille VJ, You D, Kipnis S. Endoscopic sleeve gastroplasty requiring conversion to partial gastrectomy with paraesophageal hernia repair. J Surg Case Rep 2021; 2021:rjab149. [PMID: 33976757 PMCID: PMC8096473 DOI: 10.1093/jscr/rjab149] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [Track Full Text] [Download PDF] [Figures] [Journal Information] [Subscribe] [Scholar Register] [Received: 03/09/2021] [Accepted: 03/28/2021] [Indexed: 12/03/2022] Open
Abstract
Endoluminal bariatric surgery has lower costs and perceived risks compared to traditional surgery. Endoluminal procedures are a newer approach to weight loss but long-term outcomes and complications continue to emerge. This case report is an endoscopic sleeve gastroplasty that resulted in a paraesophageal hernia repair with removal of gastroplasty sutures and partial gastrectomy.
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Affiliation(s)
- Victoria J Grille
- Department of General Surgery, Jersey Shore University Medical Center, Neptune, New Jersey, USA
| | - David You
- Department of General Surgery, Robert Wood Johnson University Medical Center, New Brunswick, New Jersey, USA
| | - Seth Kipnis
- Department of General Surgery, Jersey Shore University Medical Center, Neptune, New Jersey, USA.,Director of Robotic Surgery, Department of Surgery, Jersey Shore University Medical Center, Neptune, New Jersey, USA
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Sharaiha RZ, Hajifathalian K, Kumar R, Saunders K, Mehta A, Ang B, Skaf D, Shah S, Herr A, Igel L, Dawod Q, Dawod E, Sampath K, Carr-Locke D, Brown R, Cohen D, Dannenberg AJ, Mahadev S, Shukla A, Aronne LJ. Five-Year Outcomes of Endoscopic Sleeve Gastroplasty for the Treatment of Obesity. Clin Gastroenterol Hepatol 2021; 19:1051-1057.e2. [PMID: 33011292 DOI: 10.1016/j.cgh.2020.09.055] [Citation(s) in RCA: 88] [Impact Index Per Article: 22.0] [Reference Citation Analysis] [Abstract] [Key Words] [MESH Headings] [Track Full Text] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Received: 05/28/2020] [Revised: 09/27/2020] [Accepted: 09/28/2020] [Indexed: 02/07/2023]
Abstract
BACKGROUND AND AIMS The growing burden of obesity as a chronic disease necessitates a multifaceted approach to management. There has been an increase in the number of available endoscopic therapies for weight management with endoscopic sleeve gastroplasty (ESG) proving to be one of the best options. The long-term efficacy of ESG for management of obesity is not known. This study sought to assess the long-term safety and efficacy of ESG for treatment of obesity. METHODS This was a prospective cohort study. Participants underwent ESG in a single academic center, and were prospectively enrolled. All procedures were performed by the same therapeutic endoscopist. Patients with a body mass index of >30 kg/m2 (or >27 with comorbidities), who underwent ESG from August 2013 to August 2019 for treatment of obesity were enrolled. Patients were followed for up to 5 years after their procedure. The primary outcome was weight loss at 5 years after the procedure (% total body weight loss, TBWL) RESULTS: 216 patients (68% female) with a mean age of 46±13 years, and mean BMI of 39±6 kg/m2 underwent ESG. Out of 216 patients, 203, 96, and 68 patients were eligible for a 1-, 3-, and 5-year follow up, with complete follow-up rates of 70%, 71%, and 82%, respectively. At 5 years, mean TBWL was 15.9% (95% CI, 11.7-20.5, p < .001) and 90 and 61% of patients maintained 5 and 10% TBWL, respectively. There was an overall rate of 1.3% moderate adverse events (AEs), without any severe or fatal AEs. CONCLUSIONS Our results suggest that ESG is safe and effective for treatment of obesity, with durable long-term results for at least up to 5 years after the procedure. This procedure should be considered as a reliable option for treatment of obesity.
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Affiliation(s)
- Reem Z Sharaiha
- Division of Gastroenterology and Hepatology, Weill Cornell Medicine, New York-Presbyterian Hospital, New York, New York.
| | - Kaveh Hajifathalian
- Division of Gastroenterology and Hepatology, Weill Cornell Medicine, New York-Presbyterian Hospital, New York, New York
| | - Rekha Kumar
- Division of Endocrinology Diabetes and Metabolism, Weill Cornell Medicine, New York-Presbyterian Hospital, New York, New York
| | - Katherine Saunders
- Division of Endocrinology Diabetes and Metabolism, Weill Cornell Medicine, New York-Presbyterian Hospital, New York, New York
| | - Amit Mehta
- Division of Gastroenterology and Hepatology, Weill Cornell Medicine, New York-Presbyterian Hospital, New York, New York
| | - Bryan Ang
- Joan & Sanford I. Weill Medical College of Cornell University, New York, New York
| | - Daniel Skaf
- Joan & Sanford I. Weill Medical College of Cornell University, New York, New York
| | - Shawn Shah
- Division of Gastroenterology and Hepatology, Weill Cornell Medicine, New York-Presbyterian Hospital, New York, New York
| | - Andrea Herr
- Division of Gastroenterology and Hepatology, Weill Cornell Medicine, New York-Presbyterian Hospital, New York, New York
| | - Leon Igel
- Division of Endocrinology Diabetes and Metabolism, Weill Cornell Medicine, New York-Presbyterian Hospital, New York, New York
| | - Qais Dawod
- Division of Gastroenterology and Hepatology, Weill Cornell Medicine, New York-Presbyterian Hospital, New York, New York
| | - Enad Dawod
- Joan & Sanford I. Weill Medical College of Cornell University, New York, New York
| | - Kartik Sampath
- Division of Gastroenterology and Hepatology, Weill Cornell Medicine, New York-Presbyterian Hospital, New York, New York
| | - David Carr-Locke
- Division of Gastroenterology and Hepatology, Weill Cornell Medicine, New York-Presbyterian Hospital, New York, New York
| | - Robert Brown
- Division of Gastroenterology and Hepatology, Weill Cornell Medicine, New York-Presbyterian Hospital, New York, New York
| | - David Cohen
- Division of Gastroenterology and Hepatology, Weill Cornell Medicine, New York-Presbyterian Hospital, New York, New York
| | - Andrew J Dannenberg
- Department of Medicine, Weill Cornell Medicine, New York-Presbyterian Hospital, New York, New York
| | - Srihari Mahadev
- Division of Gastroenterology and Hepatology, Weill Cornell Medicine, New York-Presbyterian Hospital, New York, New York
| | - Alpana Shukla
- Division of Endocrinology Diabetes and Metabolism, Weill Cornell Medicine, New York-Presbyterian Hospital, New York, New York
| | - Louis J Aronne
- Division of Endocrinology Diabetes and Metabolism, Weill Cornell Medicine, New York-Presbyterian Hospital, New York, New York
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Hajifathalian K, Mehta A, Ang B, Skaf D, Shah SL, Saumoy M, Dawod Q, Dawod E, Shukla A, Aronne L, Brown RS, Cohen DE, Dannenberg AJ, Fortune B, Kumar S, Sharaiha RZ. Improvement in insulin resistance and estimated hepatic steatosis and fibrosis after endoscopic sleeve gastroplasty. Gastrointest Endosc 2021; 93:1110-1118. [PMID: 32861753 DOI: 10.1016/j.gie.2020.08.023] [Citation(s) in RCA: 56] [Impact Index Per Article: 14.0] [Reference Citation Analysis] [Abstract] [Track Full Text] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Received: 06/17/2020] [Accepted: 08/23/2020] [Indexed: 02/08/2023]
Abstract
BACKGROUND AND AIMS Nonalcoholic fatty liver disease (NAFLD) is the most common cause of chronic liver disease in the United States and is closely associated with obesity and insulin resistance (IR). Weight loss is the best treatment for NAFLD. Endoscopic sleeve gastroplasty (ESG) is a promising endoscopic procedure for treatment of obesity. Our aim is to evaluate the change in IR and estimated hepatic steatosis and fibrosis after ESG. METHODS One hundred eighteen patients with obesity and NAFLD underwent ESG and were followed for 2 years. Weight loss was evaluated as % total body weight loss. IR was evaluated using the homeostasis model assessment of insulin resistance (HOMA-IR). The previously validated hepatic steatosis index and NAFLD fibrosis score were used to estimate hepatic steatosis and risk of fibrosis. RESULTS Patients' mean body mass index was 40 ± 7 kg/m2 at baseline. Eighty-four percent of patients completed 2 years of follow-up. At 2 years, the mean total body weight loss was 15.5% (95% confidence interval, 13.3%-17.8%). Patients' HOMA-IR improved significantly from 6.7 ± 11 to 3.0 ± 1.6 after only 1 week from ESG (P = .019) with continued improvement up to 2 years (P = .03). Patients' hepatic steatosis index score improved significantly, decreasing by 4 points per year (P for trend, <.001). Patients' NAFLD fibrosis score improved significantly, decreasing by 0.3 point per year (P for trend, .034). Twenty-four patients (20%) improved their risk of hepatic fibrosis from F3-F4 or indeterminate to F0-F2, whereas only 1 patient (1%) experienced an increase in the estimated risk of fibrosis (P = .02). CONCLUSIONS Our results suggest a significant and sustained improvement in estimated hepatic steatosis and fibrosis after ESG in patients with NAFLD. Importantly, we showed an early and weight-independent improvement in insulin resistance, which lasted for 2 years after the procedure.
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Affiliation(s)
- Kaveh Hajifathalian
- Division of Gastroenterology and Hepatology, Weill Cornell Medicine, New York-Presbyterian Hospital, New York, New York
| | - Amit Mehta
- Division of Gastroenterology and Hepatology, Weill Cornell Medicine, New York-Presbyterian Hospital, New York, New York
| | - Bryan Ang
- Joan & Sanford I. Weill Medical College of Cornell University, New York, New York
| | - Daniel Skaf
- Joan & Sanford I. Weill Medical College of Cornell University, New York, New York
| | - Shawn L Shah
- Division of Gastroenterology and Hepatology, Weill Cornell Medicine, New York-Presbyterian Hospital, New York, New York
| | - Monica Saumoy
- Gastroenterology and Hepatology Department, Perelman School of Medicine, University of Pennsylvania, Philadelphia, Pennsylvania
| | - Qais Dawod
- Division of Gastroenterology and Hepatology, Weill Cornell Medicine, New York-Presbyterian Hospital, New York, New York
| | - Enad Dawod
- Joan & Sanford I. Weill Medical College of Cornell University, New York, New York
| | - Alpana Shukla
- Division of Endocrinology Diabetes and Metabolism, Weill Cornell Medicine, New York-Presbyterian Hospital, New York, New York
| | - Louis Aronne
- Division of Endocrinology Diabetes and Metabolism, Weill Cornell Medicine, New York-Presbyterian Hospital, New York, New York
| | - Robert S Brown
- Division of Gastroenterology and Hepatology, Weill Cornell Medicine, New York-Presbyterian Hospital, New York, New York
| | - David E Cohen
- Division of Gastroenterology and Hepatology, Weill Cornell Medicine, New York-Presbyterian Hospital, New York, New York
| | - Andrew J Dannenberg
- Department of Medicine, Weill Cornell Medicine, New York-Presbyterian Hospital, New York, New York, USA
| | - Brett Fortune
- Division of Gastroenterology and Hepatology, Weill Cornell Medicine, New York-Presbyterian Hospital, New York, New York
| | - Sonal Kumar
- Division of Gastroenterology and Hepatology, Weill Cornell Medicine, New York-Presbyterian Hospital, New York, New York
| | - Reem Z Sharaiha
- Division of Gastroenterology and Hepatology, Weill Cornell Medicine, New York-Presbyterian Hospital, New York, New York
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Storm AC, Abu Dayyeh BK. Metabolic function and weight loss after endoscopic sleeve gastroplasty: resistance is futile. Gastrointest Endosc 2021; 93:1119-1120. [PMID: 33691979 PMCID: PMC7937337 DOI: 10.1016/j.gie.2020.11.022] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Key Words] [MESH Headings] [Track Full Text] [Download PDF] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Received: 11/10/2020] [Accepted: 11/20/2020] [Indexed: 02/08/2023]
Affiliation(s)
- Andrew C Storm
- Division of Gastroenterology and Hepatology, Mayo Clinic, Rochester, Minnesota, USA
| | - Barham K Abu Dayyeh
- Division of Gastroenterology and Hepatology, Mayo Clinic, Rochester, Minnesota, USA
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46
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Li R, Veltzke-Schlieker W, Adler A, Specht M, Eskander W, Ismail M, Badakhshi H, Galvao MP, Zorron R. Endoscopic Sleeve Gastroplasty (ESG) for High-Risk Patients, High Body Mass Index (> 50 kg/m 2) Patients, and Contraindication to Abdominal Surgery. Obes Surg 2021; 31:3400-3409. [PMID: 33905069 DOI: 10.1007/s11695-021-05446-2] [Citation(s) in RCA: 16] [Impact Index Per Article: 4.0] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Received: 01/14/2021] [Revised: 04/18/2021] [Accepted: 04/21/2021] [Indexed: 12/17/2022]
Abstract
BACKGROUND For high-risk classified patients, patients with superobesity and in cases of contraindication to abdominal surgery, traditional bariatric surgery might lead to potential morbidity and mortality. Endoscopic sleeve gastroplasty (ESG) is a novel and effective bariatric therapy for morbidly obese patients. Our research group initially evaluated the safety, feasibility, and efficacy of ESG for high-risk, high body mass index (BMI) patients, and patients contraindicated to abdominal surgeries. METHODS Eligible patients characterized as high-risk for bariatric surgery due to high-BMI, severe comorbidities, or impenetrable abdomen were prospectively documented. ESG was performed by using Overstich® (Apollo Endosurgery, Austin, TX, USA). Primary outcomes included technical success, post-procedure adverse events and mortality, and the change of weight and BMI. RESULTS ESG was successfully performed for all patients (N = 24, mean age was 55.6 (± 9.2) years old, 75% male). Baseline weight and BMI were 157.9 (± 49.1) kg and 49.9 (± 14.4) kg/m2. According to Edmonton Obesity Staging System (EOSS), 8 (33.3%), 14 (58.3%), and 2 (8.3%) patients were respectively classified as EOSS 2, 3, and 4. Mean operation time was 114.7 (± 26.0) min, without intraoperative complication. Weight loss, BMI reduction, %total weight loss (%TWL), and %excess weight loss (%EWL) were 17.5 (± 14.6) kg, 5.6 (± 4.6) kg/m2, 12.2% (± 8.9%), and 29.1% (± 17.9%) at post-ESG 12-month, respectively. One (4.2%) moderate post-procedure adverse event (gastric mucosal bleeding) was observed. CONCLUSIONS ESG can be used as a safe, feasible, and effective option for the therapy of patients with superobesity, high-risk patients, and patients contraindicated to abdominal surgery. Graphical Abstract.
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Affiliation(s)
- Renjie Li
- Center for Bariatric and Metabolic Surgery, Klinikum Ernst von Bergmann, Charlottenstraße 72, 14467, Potsdam, Germany
| | - Wilfried Veltzke-Schlieker
- Division Interdisciplinary Endoscopy, Department for Hepatology and Gastroenterology, Campus Virchow Klinikum, Charité-Universitätsmedizin Berlin, Berlin, Germany
| | - Andreas Adler
- Division Interdisciplinary Endoscopy, Department for Hepatology and Gastroenterology, Campus Virchow Klinikum, Charité-Universitätsmedizin Berlin, Berlin, Germany
| | - Maximilian Specht
- Center for Bariatric and Metabolic Surgery, Klinikum Ernst von Bergmann, Charlottenstraße 72, 14467, Potsdam, Germany
| | - Wael Eskander
- Center for Bariatric and Metabolic Surgery, Klinikum Ernst von Bergmann, Charlottenstraße 72, 14467, Potsdam, Germany
| | - Mahmoud Ismail
- Department for Thoracic Surgery, Klinikum Ernst von Bergmann, Potsdam, Germany
| | - Harun Badakhshi
- Clinic for Radiooncology and Radiotherapy, Klinikum Ernst von Bergmann, Potsdam, Germany
| | | | - Ricardo Zorron
- Center for Bariatric and Metabolic Surgery, Klinikum Ernst von Bergmann, Charlottenstraße 72, 14467, Potsdam, Germany.
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47
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Primary Endoscopic Treatments for Obesity. CURRENT SURGERY REPORTS 2021. [DOI: 10.1007/s40137-021-00291-9] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Indexed: 10/21/2022]
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48
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The First Study Evaluating Effectiveness and Safety of the Endoscopic Sleeve Gastroplasty in HIV Patients. Obes Surg 2021; 30:1159-1162. [PMID: 31933107 DOI: 10.1007/s11695-020-04410-w] [Citation(s) in RCA: 5] [Impact Index Per Article: 1.3] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Indexed: 02/07/2023]
Abstract
The authors evaluated, retrospectively, the endoscopic sleeve gastroplasty impact in seven HIV patients, regarding effectiveness and safety outcomes. The mean baseline body mass index (BMI) was 33.76 kg/m2. The mean baseline CD4+ cell count was 690.43 cells/mm3, and the baseline viral load was undetectable. After 6 months, absolute weight loss, percentage of excess weight loss, percentage total weight loss, and BMI reduction were 20.2 ± 2.6 kg, 85.5 ± 11.1%, 21.3 ± 2.4%, and 7.1 ± 0.8 kg/m2, respectively. No patients presented severe adverse events. After 6 months, the viral load remained undetectable and the mean CD4+ cell count was 710.57 cells/mm3. The endoscopic sleeve gastroplasty is an effective and safe procedure to perform in obese HIV patients.
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49
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Shah R, Davitkov P, Abu Dayyeh BK, Saumoy M, Murad MH. AGA Technical Review on Intragastric Balloons in the Management of Obesity. Gastroenterology 2021; 160:1811-1830. [PMID: 33832658 DOI: 10.1053/j.gastro.2021.02.043] [Citation(s) in RCA: 26] [Impact Index Per Article: 6.5] [Reference Citation Analysis] [Abstract] [Track Full Text] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Indexed: 02/06/2023]
Abstract
Several strategies are available to address the obesity epidemic and range from noninvasive lifestyle interventions to medications and bariatric surgical procedures. Endoscopic bariatric techniques, such as intragastric balloons, have become an attractive alternative as a tool for weight loss that can augment the effect of lifestyle interventions. This technical review includes multiple systematic reviews performed to support a clinical practice guideline by the American Gastroenterological Association on the role of intragastric balloons as a tool for weight loss. The systematic reviews targeted a priori selected clinical questions about the effectiveness and periprocedural care of intragastric balloons and concomitant and subsequent weight-loss strategies.
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Affiliation(s)
- Raj Shah
- Case Western Reserve University School of Medicine, Cleveland, Ohio; Veterans Affairs, Northeast Ohio Healthcare System, Cleveland, Ohio; University Hospitals Cleveland Medical Center, Cleveland, Ohio
| | - Perica Davitkov
- Case Western Reserve University School of Medicine, Cleveland, Ohio; Veterans Affairs, Northeast Ohio Healthcare System, Cleveland, Ohio
| | - Barham K Abu Dayyeh
- Division of Gastroenterology and Hepatology, Department of Internal Medicine, Mayo Clinic, Rochester, Minnesota
| | - Monica Saumoy
- Division of Gastroenterology and Hepatology, University of Pennsylvania Perelman School of Medicine, Philadelphia, Pennsylvania
| | - M Hassan Murad
- Kern Center for the Science of Health Care Delivery, Mayo Clinic, Rochester, Minnesota
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50
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Currie AC, Glaysher MA, Blencowe NS, Kelly J. Systematic Review of Innovation Reporting in Endoscopic Sleeve Gastroplasty. Obes Surg 2021; 31:2962-2978. [PMID: 33774775 DOI: 10.1007/s11695-021-05355-4] [Citation(s) in RCA: 1] [Impact Index Per Article: 0.3] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Received: 12/30/2020] [Revised: 03/03/2021] [Accepted: 03/16/2021] [Indexed: 12/24/2022]
Abstract
BACKGROUND Endoscopic sleeve gastroplasty (ESG) is a novel endoscopic procedure used to treat obesity-related comorbidities. Whilst its use is increasing in clinical practice, there is comparatively little understanding about how it has been evaluated. This study aimed to systematically summarize and appraise the reporting of ESG in the context of guidelines for evaluating innovative surgical devices and procedures. METHODS Systematic searches were used to identify all published studies reporting ESG insertion. Data collected included patient selection, governance arrangements, proceduralist expertise, technique description and outcome reporting. RESULTS Searches identified 2289 abstracts; 37 full-text papers were included (one prospective comparative cohort study, 16 retrospective cohort studies, 17 prospective cohort studies and three case reports). No randomized trials were identified. Eighteen studies were conducted prospectively. The number of patients in the included studies ranged from 1 to 1000. The lower BMI limit ranged from 27 to 35 kg/m2. Research approvals were reported in 26 studies. Two studies reported on the learning curve. All studies reported some aspect of technical implementation, but many variations were noted. Suturing device used and suture pattern were the most commonly reported aspects (32 studies). Follow-up ranged from 1 to 24 months, but was 12 months or less in 28 studies. Forty-eight different outcomes were reported across all studies. CONCLUSION The literature on ESG has demonstrated some progression in reporting and analysis and the next stage of assessment should be a randomized controlled trial to demonstrate efficacy.
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Affiliation(s)
- Andrew C Currie
- Department of Bariatric Surgery, Ashford & St Peter's Hospital NHS Trust, Guildford Street, Chertsey, UK.
| | - Michael A Glaysher
- Department of Upper Gastrointestinal Surgery, University Hospital Southampton NHS Foundation Trust, Southampton, UK
| | - Natalie S Blencowe
- NIHR Biomedical Research Centre, University Hospitals Bristol NHS Foundation Trust and University of Bristol, Bristol, UK
| | - Jamie Kelly
- Department of Upper Gastrointestinal Surgery, University Hospital Southampton NHS Foundation Trust, Southampton, UK
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