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de Moura DTH, Sánchez-Luna SA, Silva AF, Bestetti AM. Intragastric Balloons: Practical Considerations. Gastrointest Endosc Clin N Am 2024; 34:687-714. [PMID: 39277299 DOI: 10.1016/j.giec.2024.04.013] [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: 09/17/2024]
Abstract
Obesity is escalating, projected to affect 17.5% of adults globally and afflict 400 million children by 2035. Managing this intricate and chronic condition demands personalized, multidisciplinary approaches. While dietary changes, lifestyle modifications, and medications yield short-term results, long-term outcomes are often poor, with bariatric surgery standing out as the most effective option. However, only a small fraction undergoes surgery due to various barriers. Intragastric balloon (IGB) emerges as a minimally invasive alternative, approved by major regulatory bodies. This review adresses the pivotal role of IGB in obesity management, delving into its history and technological evolution.
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Affiliation(s)
- D T H de Moura
- Gastrointestinal Endoscopy Division, Instituto D´Or de Pesquisa e Ensino (IDOR), Hospital Vila Nova Star, R. Dr. Alceu de Campos Rodrigues, 126 - Vila Nova Conceição, São Paulo, São Paulo 04544-000, Brazil; Gastrointestinal Endoscopy Unit, Department of Gastroenterology, Hospital das Clínicas da Faculdade de Medicina da Universidade de São Paulo, Av. Dr. Enéas de Carvalho Aguiar, 255 Cerqueira César, 05403-000, Brazil.
| | - Sergio A Sánchez-Luna
- Division of Gastroenterology & Hepatology, Department of Internal Medicine, Basil I. Hirschowitz Endoscopic Center of Excellence, The University of Alabama at Birmingham Heersink School of Medicine, 510 20th Street S, LHFOT 1203, Birmingham, AL 35294, USA
| | - Adriana Fernandes Silva
- Gastrointestinal Endoscopy Unit, Department of Gastroenterology, Hospital das Clínicas da Faculdade de Medicina da Universidade de São Paulo, Av. Dr. Enéas de Carvalho Aguiar, 255 Cerqueira César, 05403-000, Brazil
| | - Alexandre Moraes Bestetti
- Gastrointestinal Endoscopy Division, Instituto D´Or de Pesquisa e Ensino (IDOR), Hospital Vila Nova Star, R. Dr. Alceu de Campos Rodrigues, 126 - Vila Nova Conceição, São Paulo, São Paulo 04544-000, Brazil; Gastrointestinal Endoscopy Unit, Department of Gastroenterology, Hospital das Clínicas da Faculdade de Medicina da Universidade de São Paulo, Av. Dr. Enéas de Carvalho Aguiar, 255 Cerqueira César, 05403-000, Brazil
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Flynn DJ, Soltani AK, Singh A. Spontaneous Intragastric Balloon Hyperinflation: Two Cases and Outcomes. Obes Surg 2024; 34:3087-3090. [PMID: 38879726 DOI: 10.1007/s11695-024-07332-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: 05/20/2024] [Revised: 05/28/2024] [Accepted: 05/29/2024] [Indexed: 09/15/2024]
Abstract
Endoscopic bariatric therapies can provide treatment options for obesity in non-surgical candidates, as a part of combination or serial treatment plans, and for the reduction of obesity-related comorbidities. Several complications of intragastric balloons have been documented, but spontaneous hyperinflation is a risk that has not been well reported previously. We describe two cases of spontaneous intragastric balloon hyperinflation and their outcomes.
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Affiliation(s)
- Duncan J Flynn
- Department of Gastroenterology and Hepatology, Beth Israel Deaconess Medical Center, Boston, MA, USA.
| | | | - Amandeep Singh
- Division of Gastroenterology, Massachusetts General Hospital, Boston, MA, USA
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Pessorrusso F, Mehta SV, Sullivan S. Update on Endoscopic Treatments for Obesity. Curr Obes Rep 2024; 13:364-376. [PMID: 38388770 DOI: 10.1007/s13679-024-00551-6] [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] [Indexed: 02/24/2024]
Abstract
PURPOSE OF REVIEW Increased morbidity seen with rising obesity rates continues to place an unheralded burden on our health system. Lack of higher bariatric surgery utilization and limitations with lifestyle modification and pharmacotherapy highlights the need for additional therapies for obesity. Endoscopic bariatric and metabolic therapies (EBMT) are effective, safe treatments for obesity. Current FDA-approved EBMT are confined to gastric modalities while small bowel directed therapies are still considered investigational. This review highlights current modalities of EBMT. RECENT FINDINGS Many randomized controlled trials have been performed, including both open label and sham-controlled, which have demonstrated safety and efficacy of EBMT over lifestyle therapy alone. In addition, emerging evidence from clinical experience further supports EBMT for treatment of obesity. Current evidence supports the safety and efficacy of EBMT for obesity treatment in conjunction with lifestyle therapy. They can also be used concurrently with weight loss medications to increase total weight loss.
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Affiliation(s)
- Fernanda Pessorrusso
- Division of Gastroenterology and Hepatology, University of Colorado School of Medicine, Academic Office 1, 12631 E. 17th Ave, Mail Stop B158, Aurora, CO, 80045, USA
| | - Sagar V Mehta
- Division of Gastroenterology, Geisinger Health System, Danville, PA, USA
| | - Shelby Sullivan
- Division of Gastroenterology and Hepatology, University of Colorado School of Medicine, Academic Office 1, 12631 E. 17th Ave, Mail Stop B158, Aurora, CO, 80045, USA.
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Ameen S, Merchant HA. Intragastric balloons for obesity: critical review of device design, efficacy, tolerability, and unmet clinical needs. Expert Rev Med Devices 2024; 21:37-54. [PMID: 38030993 DOI: 10.1080/17434440.2023.2289691] [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: 01/11/2023] [Accepted: 11/27/2023] [Indexed: 12/01/2023]
Abstract
INTRODUCTION Sustaining a healthy weight is a challenge and obesity, with associated risk of co-morbidities, is a major public health concern. Bariatric surgery has shown a great promise for many where pharmacological and lifestyle interventions failed to work. However, challenges and limitations associated with bariatric surgery has pushed the demand for less invasive, reversible (anatomically) interventions, such as intragastric balloons (IGBs). AREAS COVERED This review critically appraises IGBs used in the past, present, and those in clinical trials, discussing the device designs, limitations, placement and removal techniques, patient eligibility, efficacy, and safety issues. EXPERT OPINION Several intragastric balloons were developed over the years that brought excitement to patients and healthcare professionals alike. Albeit good efficacy, there had been several safety issues reported with IGBs such as spontaneous deflation, intestinal occlusion, gut perforation, and mucosal ulcerations. This led to evolution of IGBs design; device material, filling mechanism, fluid type, inflation volume, and further innovations to ease ingestion and removal of device. There are some IGB devices under development aimed to swallow like a conventional pill and excrete naturally through defecation, however, how successful they will be in clinical practice in terms of their efficacy and tolerability remains to be seen in the future.
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Affiliation(s)
- Sara Ameen
- Department of Pharmacy, School of Applied Sciences, University of Huddersfield, West Yorkshire, UK
| | - Hamid A Merchant
- Department of Pharmacy, School of Applied Sciences, University of Huddersfield, West Yorkshire, UK
- Department of Bioscience, School of Health, Sport and Bioscience, University of East London, London, UK
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Mauro A, Lusetti F, Scalvini D, Bardone M, De Grazia F, Mazza S, Pozzi L, Ravetta V, Rovedatti L, Sgarlata C, Strada E, Torello Viera F, Veronese L, Olivo Romero DE, Anderloni A. A Comprehensive Review on Bariatric Endoscopy: Where We Are Now and Where We Are Going. MEDICINA (KAUNAS, LITHUANIA) 2023; 59:636. [PMID: 36984637 PMCID: PMC10052707 DOI: 10.3390/medicina59030636] [Citation(s) in RCA: 5] [Impact Index Per Article: 2.5] [Reference Citation Analysis] [Abstract] [Key Words] [MESH Headings] [Track Full Text] [Subscribe] [Scholar Register] [Received: 03/05/2023] [Revised: 03/14/2023] [Accepted: 03/18/2023] [Indexed: 03/30/2023]
Abstract
Background: Obesity is a chronic disease that impairs quality of life and leads to several comorbidities. When conservative therapies fail, bariatric surgical options such as Roux-en-Y gastric bypass (RYGB) and sleeve gastrectomy (SG) are the most effective therapies to induce persistent weight loss. Over the last two decades, bariatric endoscopy has become a valid alternative to surgery in specific settings. Primary bariatric endoscopic therapies: Restrictive gastric procedures, such as intragastric balloons (IGBs) and endoscopic gastroplasty, have been shown to be effective in inducing weight loss compared to diet modifications alone. Endoscopic gastroplasty is usually superior to IGBs in maintaining weight loss in the long-term period, whereas IGBs have an established role as a bridge-to-surgery approach in severely obese patients. IGBs in a minority of patients could be poorly tolerated and require early removal. More recently, novel endoscopic systems have been developed with the combined purpose of inducing weight loss and improving metabolic conditions. Duodenal mucosal resurfacing demonstrated efficacy in this field in its early trials: significant reduction from baseline of HbA1c values and a modest reduction of body weight were observed. Other endoscopic malabsorptive have been developed but need more evidence. For example, a pivotal trial on duodenojejunal bypasses was stopped due to the high rate of severe adverse events (hepatic abscesses). Optimization of these more recent malabsorptive endoscopic procedures could expand the plethora of bariatric patients that could be treated with the intention of improving their metabolic conditions. Revisional bariatric therapies: Weight regain may occur in up to one third of patients after bariatric surgery. Different endoscopic procedures are currently performed after both RYGB and SG in order to modulate post-surgical anatomy. The application of argon plasma coagulation associated with endoscopic full-thickness suturing systems (APC-TORe) and Re-EndoSleeve have shown to be the most effective endoscopic treatments after RYGB and SG, respectively. Both procedures are usually well tolerated and have a very low risk of stricture. However, APC-TORe may sometimes require more than one session to obtain adequate final results. The aim of this review is to explore all the currently available primary and revisional endoscopic bariatric therapies focusing on their efficacy and safety and their potential application in clinical practice.
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Affiliation(s)
- Aurelio Mauro
- Gastroenterology and Endoscopy Unit, Fondazione IRCCS Policlinico San Matteo, 27100 Pavia, Italy
| | - Francesca Lusetti
- Gastroenterology and Endoscopy Unit, Fondazione IRCCS Policlinico San Matteo, 27100 Pavia, Italy
- Specialization School of Diseases of Digestive System Pavia, University of Pavia, 27100 Pavia, Italy
| | - Davide Scalvini
- Gastroenterology and Endoscopy Unit, Fondazione IRCCS Policlinico San Matteo, 27100 Pavia, Italy
- Specialization School of Diseases of Digestive System Pavia, University of Pavia, 27100 Pavia, Italy
| | - Marco Bardone
- Gastroenterology and Endoscopy Unit, Fondazione IRCCS Policlinico San Matteo, 27100 Pavia, Italy
| | - Federico De Grazia
- Gastroenterology and Endoscopy Unit, Fondazione IRCCS Policlinico San Matteo, 27100 Pavia, Italy
| | - Stefano Mazza
- Gastroenterology and Endoscopy Unit, Fondazione IRCCS Policlinico San Matteo, 27100 Pavia, Italy
| | - Lodovica Pozzi
- Gastroenterology and Endoscopy Unit, Fondazione IRCCS Policlinico San Matteo, 27100 Pavia, Italy
| | - Valentina Ravetta
- Gastroenterology and Endoscopy Unit, Fondazione IRCCS Policlinico San Matteo, 27100 Pavia, Italy
| | - Laura Rovedatti
- Gastroenterology and Endoscopy Unit, Fondazione IRCCS Policlinico San Matteo, 27100 Pavia, Italy
| | - Carmelo Sgarlata
- Gastroenterology and Endoscopy Unit, Fondazione IRCCS Policlinico San Matteo, 27100 Pavia, Italy
| | - Elena Strada
- Gastroenterology and Endoscopy Unit, Fondazione IRCCS Policlinico San Matteo, 27100 Pavia, Italy
| | - Francesca Torello Viera
- Gastroenterology and Endoscopy Unit, Fondazione IRCCS Policlinico San Matteo, 27100 Pavia, Italy
| | - Letizia Veronese
- Gastroenterology and Endoscopy Unit, Fondazione IRCCS Policlinico San Matteo, 27100 Pavia, Italy
| | - Daniel Enrique Olivo Romero
- Gastroenterology and Endoscopy Unit, Fondazione IRCCS Policlinico San Matteo, 27100 Pavia, Italy
- Digestive Endoscopy Unit, Hospital Nacional Zacamil, San Salvador 01120, El Salvador
| | - Andrea Anderloni
- Gastroenterology and Endoscopy Unit, Fondazione IRCCS Policlinico San Matteo, 27100 Pavia, Italy
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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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Results of adjustable intragastric balloon use according to Body Mass Index values. JOURNAL OF CONTEMPORARY MEDICINE 2022. [DOI: 10.16899/jcm.1058508] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Indexed: 11/20/2022] Open
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Abu Dayyeh BK, Maselli DB, Rapaka B, Lavin T, Noar M, Hussan H, Chapman CG, Popov V, Jirapinyo P, Acosta A, Vargas EJ, Storm AC, Bazerbachi F, Ryou M, French M, Noria S, Molina D, Thompson CC. Adjustable intragastric balloon for treatment of obesity: a multicentre, open-label, randomised clinical trial. Lancet 2021; 398:1965-1973. [PMID: 34793746 DOI: 10.1016/s0140-6736(21)02394-1] [Citation(s) in RCA: 63] [Impact Index Per Article: 15.8] [Reference Citation Analysis] [Abstract] [MESH Headings] [Track Full Text] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Received: 10/14/2021] [Revised: 10/23/2021] [Accepted: 10/26/2021] [Indexed: 12/15/2022]
Abstract
BACKGROUND Intragastric balloons are anatomy-preserving, minimally invasive obesity therapies. Enhanced tolerance and durability could help broaden clinical adoption. We investigated the safety and efficacy of an adjustable intragastric balloon (aIGB) in adults with obesity. METHODS In this prospective, multicentre, open-label, randomised clinical trial done at seven US sites, adults aged 22-65 years with obesity were randomly assigned (2:1) to aIGB with lifestyle intervention or lifestyle intervention alone (control) for 32 weeks. Balloon volume could be increased to facilitate weight loss or decreased for tolerability. Coprimary endpoints included mean percentage total bodyweight loss and responder rate (≥5% total bodyweight loss) at 32 weeks. We used a multiple imputed intention-to-treat population analysis. This study was registered with ClinicalTrials.gov, NCT02812160. FINDINGS Between Aug 9, 2016, and Dec 7, 2018, we randomly assigned 288 patients to aIGB (n=187 [65%]) or control (n=101 [35%]) groups. Mean total bodyweight loss at 32 weeks was 15·0% (95% CI 13·9-16·1) in the aIGB group versus 3·3% (2·0-4·6) in the control group (p<0·0001). Clinical response was observed in 171 (92%) patients in the aIGB group. Adjustments to the aIGB occurred in 145 (80%) patients for weight loss plateau or intolerance. Upward volume adjustment facilitated an additional mean 5·2% (4·5-5·8) total bodyweight loss. Downward volume adjustment allowed 21 (75%) patients in the aIGB group to complete the full duration of therapy. Intolerance caused early removal of the device in 31 (17%) patients. No micronutrient deficiencies were observed in the aIGB cohort. Device-related serious adverse events were observed in seven (4%) patients, without any deaths. INTERPRETATION When aIGB was combined with lifestyle modification, significant weight loss was achieved and maintained for 6 months following removal. Balloon volume adjustability permitted individualised therapy, maximising weight loss and tolerance. FUNDING Spatz Medical.
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Affiliation(s)
- Barham K Abu Dayyeh
- Division of Gastroenterology and Hepatology, Mayo Clinic, Rochester, MN, USA.
| | - Daniel B Maselli
- Division of Gastroenterology and Hepatology, Mayo Clinic, Rochester, MN, USA
| | - Babusai Rapaka
- Division of Gastroenterology and Hepatology, Mayo Clinic, Rochester, MN, USA
| | - Thomas Lavin
- Surgical Associates of Louisiana, Metairie, LA, USA
| | - Mark Noar
- Endoscopic MicroSurgery Associates, Towson, MD, USA
| | - Hisham Hussan
- Division of Gastroenterology, Hepatology and Nutrition, Ohio State University Wexner Medical Center, Columbus, OH, USA
| | - Christopher G Chapman
- Division of Gastroenterology, Hepatology and Nutrition, University of Chicago Medicine, Chicago, IL
| | - Violeta Popov
- Division of Gastroenterology, NYU Langone Health, VA Medical Center, New York, NY, USA
| | - Pichamol Jirapinyo
- Division of Gastroenterology, Brigham and Women's Hospital, Boston, MA, USA
| | - Andres Acosta
- Division of Gastroenterology and Hepatology, Mayo Clinic, Rochester, MN, USA
| | - Eric J Vargas
- Division of Gastroenterology and Hepatology, Mayo Clinic, Rochester, MN, USA
| | - Andrew C Storm
- Division of Gastroenterology and Hepatology, Mayo Clinic, Rochester, MN, USA
| | - Fateh Bazerbachi
- CentraCare, Interventional Endoscopy Program, St Cloud Hospital, St Cloud, MN, USA
| | - Marvin Ryou
- Division of Gastroenterology, Brigham and Women's Hospital, Boston, MA, USA
| | | | - Sabrena Noria
- Division of Gastroenterology, Hepatology and Nutrition, Ohio State University Wexner Medical Center, Columbus, OH, USA
| | - Daniel Molina
- Biostatistics and Clinical Data Management, Technical Resources International, Bethesda, MD, USA
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Jamal MH, Al-Kanawati N, ElAbd R, Al-Haddad M, AlKhadher T, Hamshari F, Akrouf S. A Study Examining the Orbera365 Intragastric Balloon Safety and Effects on Weight Loss. Obes Surg 2021; 31:5342-5347. [PMID: 34591263 PMCID: PMC8482955 DOI: 10.1007/s11695-021-05729-8] [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: 07/20/2021] [Revised: 09/16/2021] [Accepted: 09/22/2021] [Indexed: 11/28/2022]
Abstract
INTRODUCTION The Orbera365 is a new balloon that can stay in the stomach for up to 12 months. The aim of this study is to investigate the safety and effect of Orbera365. METHOD Prospective study on our initial experience with a consecutive group of patients who underwent the insertion of Orbera365 in the period between September 2019 and August 2020. The patients were followed up to assess, pain, nausea, and vomiting after procedure, weight loss, and the complication rate. RESULTS A total of 97 patients underwent Orbera365 placement. Mean weight and BMI before the procedure were 93.8 ± 15.2 kg and 35.2 ± 4.4 kg/m2, respectively, which dropped to 80.6 ± 13.1 kg and 29.8 ± 4.0 kg/m2 by 8.2 months and were 82.4 ± 16.1 and 30.4 ± 4.6 at the last day of follow-up of 12.9 months. Fourteen patients did not tolerate the balloon, and had to have it removed, six of them in the first week, and eight within the first 8 months of insertion. Other than intolerance, two patients had balloon rupture, three patients had leakage at time of insertion requiring balloon replacement, two patient had pancreatitis, one patient had spontaneous balloon hyperinflation, and one patient had balloon deflation and vomited the balloon. At day of last follow-up, total body weight loss % (TBWL%) was 16.2 ± 10.1 and %EWL was 54.6 ± 38.3. CONCLUSION Orbera365 is safe and effective for weight loss.
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Affiliation(s)
- Mohammad H Jamal
- Department of Surgery, Faculty of Medicine, Health Sciences Center, Kuwait University, Kuwait City, Kuwait. .,Obesity and Metabolic Unit, The Clinic, Kuwait City, Kuwait.
| | | | - Rawan ElAbd
- Department of Surgery, Faculty of Medicine, Health Sciences Center, Kuwait University, Kuwait City, Kuwait
| | | | | | | | - Shehab Akrouf
- Department of Surgery, Amiri Hospital, Kuwait City, Kuwait
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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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12
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Stavrou G, Shrewsbury A, Kotzampassi K. Six intragastric balloons: Which to choose? World J Gastrointest Endosc 2021; 13:238-259. [PMID: 34512874 PMCID: PMC8394181 DOI: 10.4253/wjge.v13.i8.238] [Citation(s) in RCA: 30] [Impact Index Per Article: 7.5] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Download PDF] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Received: 03/10/2021] [Revised: 05/17/2021] [Accepted: 07/13/2021] [Indexed: 02/06/2023] Open
Abstract
Endoscopically placed intragastric balloons (IGBs) have played a significant role in obesity treatment over the last 30 years, successfully bridging the gap between lifestyle modification/pharmacotherapy and bariatric surgery. Since they provide a continuous sensation of satiety that helps the ingestion of smaller portions of food, facilitating maintenance of a low-calorie diet, they have generally been considered an effective and reversible, less invasive, non-surgical procedure for weight loss. However, some studies indicate that balloons have limited sustainable effectiveness for the vast majority attempting such therapy, resulting in a return to the previous weight after balloon removal. In this review we try to summarize the pros and cons of various balloon types, to guide decision making for both the physician and the obese individual looking for effective treatment. We analyzed the six most commonly used IGBs, namely the liquid-filled balloons Orbera, Spatz3, ReShape Duo and Elipse, and the gas-filled Heliosphere and Obalon - also including comments on the adjustable Spatz3, and the swallowable Obalon and Elipse - to optimize the choice for maximum efficacy and safety.
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Affiliation(s)
- George Stavrou
- Department of Colorectal Surgery, Addenbrooke’s Hospital, Cambridge CB22QQ, United Kingdom
| | - Anne Shrewsbury
- Department of Surgery, Endoscopy Unit, Aristotle University of Thessaloniki, Thessaloniki 54636, Greece
| | - Katerina Kotzampassi
- Department of Surgery, Endoscopy Unit, Aristotle University of Thessaloniki, Thessaloniki 54636, Greece
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13
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Telese A, Sehgal V, Magee CG, Naik S, Alqahtani S, Lovat L, Haidry RJ. Bariatric and Metabolic Endoscopy: A New Paradigm. Clin Transl Gastroenterol 2021; 12:e00364. [PMID: 34142665 PMCID: PMC8216681 DOI: 10.14309/ctg.0000000000000364] [Citation(s) in RCA: 8] [Impact Index Per Article: 2.0] [Reference Citation Analysis] [Abstract] [MESH Headings] [Track Full Text] [Download PDF] [Figures] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Received: 10/23/2020] [Accepted: 04/14/2021] [Indexed: 12/26/2022] Open
Abstract
The prevalence of obesity, type 2 diabetes mellitus, and metabolic syndromes is increasing globally. Minimally invasive metabobariatric (MB) endoscopic therapies are adjunct treatments that can potentially bridge the gap between surgical interventions and medical therapy. A growing number of MB techniques are becoming available, allowing for more personalized and patient-targeted treatment options for specific disease states. MB techniques are less invasive than surgery and can precisely target different parts of the gastrointestinal tract that may be responsible for the pathophysiology of obesity and metabolic syndromes such as type 2 diabetes mellitus. These alternatives should be selected on an individualized patient basis to balance the expected clinical outcomes and desired anatomical targets with the level of invasiveness and degree of acceptable risk. Each MB intervention presents great flexibility allowing for a tailored intervention and different levels of patient engagement. Patient awareness and motivation are essential to avoid therapy withdrawal and failure. Differences between MB procedures in terms of weight loss and metabolic benefit will be discussed in this review, along with the insights on clinical decision-making processes to evaluate the potential of further evolution and growth of bariatric and metabolic endoscopy.
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Affiliation(s)
- Andrea Telese
- Department of Gastrointestinal Services, University College London Hospital, London, UK;
| | - Vinay Sehgal
- Department of Gastrointestinal Services, University College London Hospital, London, UK;
| | - Cormac G. Magee
- Department of Gastrointestinal Services, University College London Hospital, London, UK;
- Centre for Obesity research, University College London, London, UK;
| | - S. Naik
- Centre for Obesity research, University College London, London, UK;
| | - S.A. Alqahtani
- Division of Gastroenterology and Hepatology, Johns Hopkins University, Baltimore, Maryland, USA;
- Liver Transplantation Unit, King Faisal Specialist Hospital and Research Center, Riyadh, Saudi Arabia
| | - L.B. Lovat
- Department of Gastrointestinal Services, University College London Hospital, London, UK;
- Division of Surgery and Interventional Science, University College London, London, UK.
| | - Rehan J. Haidry
- Department of Gastrointestinal Services, University College London Hospital, London, UK;
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McCarty TR, Farrelly J, Njei B, Jamidar P, Muniraj T. Role of Prophylactic Cholecystectomy After Endoscopic Sphincterotomy for Biliary Stone Disease: A Systematic Review and Meta-analysis. Ann Surg 2021; 273:667-675. [PMID: 32590541 DOI: 10.1097/sla.0000000000003977] [Citation(s) in RCA: 3] [Impact Index Per Article: 0.8] [Reference Citation Analysis] [Abstract] [MESH Headings] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Indexed: 12/27/2022]
Abstract
OBJECTIVE The aim of this study was to perform a structured systematic review and meta-analysis to evaluate the effectiveness and complication rate of cholecystectomy deferral versus prophylactic cholecystectomy among patients post-endoscopic biliary sphincterotomy for common bile duct stones. BACKGROUND Although previous reports suggest a decreased risk of biliary complications with prophylactic cholecystectomy, biliary endoscopic cholangiopancreatography (ERCP) with sphincterotomy may provide a role for deferring cholecystectomy with the gallbladder left in situ. METHODS Searches of PubMed, EMBASE, Web of Science, and Cochrane Library databases were performed through August 2019 in accordance with Preferred Reporting Items for Systematic Reviews and Meta-Analyses and Meta-Analysis of Observational Studies in Epidemiology guidelines. Measured outcomes included: mortality, recurrent biliary pain or cholecystitis, pancreatitis, cholangitis, and eventual need for cholecystectomy. Random effects models were used to determine pooled effect size and corresponding 95% confidence intervals (CIs). RESULTS Nine studies (n = 1605) were included. A total of 53.8% (n = 864) patients had deferred cholecystectomy post-sphincterotomy. Deferral cholecystectomy as compared to prophylactic cholecystectomy resulted in a significant increased risk of mortality [odds raio (OR) 2.56 (95% confidence interval, CI 1.54-4.23); P < 0.0001; I2 = 18.49]. Patients who did not undergo prophylactic cholecystectomy developed more recurrent biliary pain or cholecystitis [OR 5.10 (95% CI 3.39-7.67); P < 0.0001; I2 = 0.00]. Rate of pancreatitis [OR 3.11 (95% CI 0.99-9.83); P = 0.053; I2 = 0.00] and cholangitis [OR 1.49 (95% CI 0.74-2.98); P = 0.264; I2 = 0.00] was unaffected. Overall, 26.00% (95% CI 14.00-40.00) of patients with deferred prophylactic cholecystectomy required eventual cholecystectomy. CONCLUSIONS Prophylactic cholecystectomy remains the preferred strategy compared to a deferral approach with gallbladder in situ post-sphincterotomy for patients with bile duct stones. Future studies may highlight a subset of patients (ie, those with large balloon biliary dilation) that may not require cholecystectomy.
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Affiliation(s)
- Thomas R McCarty
- Division of Gastroenterology, Hepatology and Endoscopy. Brigham and Women's Hospital. Boston, MA
- Harvard Medical School, Boston, MA
| | - James Farrelly
- Section of General Surgery, Trauma, and Critical Care, Yale University School of Medicine. New Haven, CT
| | - Basile Njei
- Section of Digestive Diseases, Yale University School of Medicine. New Haven, CT
| | - Priya Jamidar
- Section of Digestive Diseases, Yale University School of Medicine. New Haven, CT
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15
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McCarty TR, Thompson CC. The current state of bariatric endoscopy. Dig Endosc 2021; 33:321-334. [PMID: 32301158 DOI: 10.1111/den.13698] [Citation(s) in RCA: 11] [Impact Index Per Article: 2.8] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Received: 09/30/2019] [Revised: 04/02/2020] [Accepted: 04/13/2020] [Indexed: 02/08/2023]
Abstract
A variety of endoscopic bariatric and metabolic treatments (EBMTs) have been developed in recent years to combat the growing prevalence of obesity in the United States (US) and worldwide. This manuscript reviews the current state of bariatric endoscopy, detailing all US Food and Drug Administration (FDA) approved EBMTs including space-occupying intragastric balloons (IGBs), aspiration therapy, and endoscopic tissue apposition devices. Additionally, this review describes non-FDA approved treatments including additional IGBs, endoluminal bypass liners, duodenal mucosal resurfacing, and endoscopically placed anastomosis devices.
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Affiliation(s)
- Thomas R McCarty
- Division of Gastroenterology, Hepatology and Endoscopy, Brigham and Women's Hospital, Boston, USA.,Harvard Medical School, Boston, USA
| | - Christopher C Thompson
- Division of Gastroenterology, Hepatology and Endoscopy, Brigham and Women's Hospital, Boston, USA.,Harvard Medical School, Boston, USA
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16
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Silva LB, Neto MG. Intragastric balloon. MINIM INVASIV THER 2021; 31:505-514. [PMID: 33571068 DOI: 10.1080/13645706.2021.1874420] [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: 10/22/2022]
Abstract
The intragastric balloon is a temporary and minimally invasive therapy for weight loss, currently being the main choice for mild obesity. As a space-occupying device, it reduces stomach capacity, resulting in decreased hunger and food intake. There are different balloon models, filled with liquid or air. The most used is the non-adjustable liquid-filled balloon, due to its lower rate of complications. The mechanism of action is multifactorial, involving physiological and neurohormonal changes. The device functions as an artificial bezoar, filling the stomach and leading to early satiety. In the Brazilian Intragastric Balloon Consensus Statement, there was a mean excess weight loss of 18.4%, showing effective weight loss and good safety profile. It is a valid option for overweight and obese patients unresponsive to clinical therapy or who are either not candidates for surgery or who do not wish to undergo a definitive procedure. Besides weight loss, recent studies have shown a positive effect on metabolic parameters. New devices have been developed, such as procedureless and adjustable balloons, with promising results.
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Affiliation(s)
- Lyz Bezerra Silva
- Department of Surgery, Federal University of Pernambuco, Recife, Brazil
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17
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Lari E, Burhamah W, Lari A, Alsaeed T, Al-Yaqout K, Al-Sabah S. Intra-gastric balloons - The past, present and future. Ann Med Surg (Lond) 2021; 63:102138. [PMID: 33664941 PMCID: PMC7903294 DOI: 10.1016/j.amsu.2021.01.086] [Citation(s) in RCA: 2] [Impact Index Per Article: 0.5] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Download PDF] [Journal Information] [Subscribe] [Scholar Register] [Received: 01/08/2021] [Accepted: 01/23/2021] [Indexed: 01/28/2023] Open
Abstract
Obesity is a complex metabolic illness that is interrelated to a plethora of complications that predispose to avoidable morbidity and mortality. The considerable impact of obesity has invited various therapies ranging from lifestyle advice, pharmacotherapy, endoscopic bariatric therapy and ultimately surgery. Intragastric balloons are space-occupying therapies that aim to increase satiety through mechanical and neuroendocrine mechanisms. Their prevalence is owed to their ease of administration and general safety. However, long term data concerning safety and efficacy is scarce when considering the various types of balloons in use. In this review, we discuss the intragastric balloon comprehensively in terms of efficacy, safety, limitations and future direction.
A rise in the prevalence of obesity is evident. There is a continuous drive towards non-invasive management. Intra-gastric balloons are a valuable adjunct for the management of obesity. Promising outcomes are evident especially in combination with lifestyle modification and pharmacotherapy.
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18
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Goyal H, Kopel J, Perisetti A, Mann R, Ali A, Tharian B, Saligram S, Inamdar S. Endobariatric procedures for obesity: clinical indications and available options. Ther Adv Gastrointest Endosc 2021; 14:2631774520984627. [PMID: 33629061 PMCID: PMC7841245 DOI: 10.1177/2631774520984627] [Citation(s) in RCA: 1] [Impact Index Per Article: 0.3] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Download PDF] [Figures] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Received: 07/29/2020] [Accepted: 12/03/2020] [Indexed: 12/18/2022] Open
Abstract
Obesity remains a growing public health epidemic that has increased healthcare costs and related comorbidities. Current treatment guidelines encourage a multidisciplinary approach starting from patient selection, interventions, and long-term follow-up to maintain weight loss. However, these conservative interventions are largely ineffective at reducing body weight due to low adherence to the treatment regimen. Recently, endoscopic bariatric therapies have become an attractive alternative to traditional invasive bariatric surgeries due to their improved efficacy, safety, and cost-effectiveness. Endoscopic bariatric therapies include intragastric balloon placement, endoscopic sleeve gastroplasty, gastric bypass revision, and aspiration therapy. These procedures fall into two separate categories depending on the primary mechanism involved: restrictive or malabsorptive. Restrictive methods, such as the Orbera® and ReShape™ intragastric balloons, increase satiation and delay gastric emptying while decreasing the amount of food that can be ingested. In contrast, malabsorptive devices, such as the EndoBarrier®, interfere with the small intestine's ability to absorb food while restoring normal gastrointestinal hormone levels regulating satiation. Together, these techniques provide useful alternatives for patients in whom pharmacological or lifestyle modifications have proven ineffective. Despite these advantages, the long-term effects of these procedures on metabolic changes remain to be studied. Furthermore, the management of complications from these procedures continues to evolve. In this review, we aim to elaborate on the clinical indications and efficacy of the endobariatric procedures, together with various types of available endoscopic bariatric therapy procedures.
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Affiliation(s)
- Hemant Goyal
- The Wright Center for Graduate Medical
Education, 501 South Washington Avenue, Scranton, PA 18505, USA
| | - Jonathan Kopel
- Department of Medicine, Texas Tech University
Health Sciences Center, Lubbock, TX, USA
| | - Abhilash Perisetti
- Department of Gastroenterology and Hepatology,
University of Arkansas for Medical Sciences, Little Rock, AR, USA
| | - Rupinder Mann
- Department of Internal Medicine, Saint Agnes
Medical Center, Fresno, CA, USA
| | - Aman Ali
- The Commonwealth Medical College, Wilkes Barre
General Hospital, Wilkes-Barre, PA, USA
| | - Benjamin Tharian
- University of Arkansas for Medical Sciences,
Little Rock, AR, USA
| | - Shreyas Saligram
- Division of Advanced Endoscopy,
Gastroenterology, Hepatology, and Nutrition, Department of Medicine,
University of Texas Health San Antonio, San Antonio, TX, USA
| | - Sumant Inamdar
- University of Arkansas for Medical Sciences,
Little Rock, AR, USA
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19
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Cho JH, Bilal M, Kim MC, Cohen J. The Clinical and Metabolic Effects of Intragastric Balloon on Morbid Obesity and Its Related Comorbidities. Clin Endosc 2021; 54:9-16. [PMID: 33684281 PMCID: PMC7939781 DOI: 10.5946/ce.2020.302] [Citation(s) in RCA: 2] [Impact Index Per Article: 0.5] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Download PDF] [Figures] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Received: 11/18/2020] [Revised: 01/10/2021] [Accepted: 01/12/2021] [Indexed: 12/16/2022] Open
Abstract
Obesity is becoming increasingly prevalent worldwide, and its metabolic sequelae lead to a significant burden on healthcare resources. Options for the management of obesity include lifestyle modification, pharmacological treatment, surgery, and endoscopic bariatric therapies (EBTs). Among these, EBTs are more effective than diet and lifestyle modification and are less invasive than bariatric surgery. In recent years, there have been significant advances in technologies pertaining to EBTs. Of all the available EBTs, there is a significant amount of clinical experience and published data regarding intragastric balloons (IGBs) because of their comparatively long development period. Currently, the United States Food and Drug Administration (FDA) has approved three IGBs, including Orbera (Apollo Endosurgery, Austin, TX, USA), ReShape Duo (ReShape Medical, San Clemente, CA, USA), and Obalon (Obalon Therapeutics, Carlsbad, CA, USA). The aim of this review is to summarize the available literature on the efficacy of IGBs in weight loss and their impact on obesity-related metabolic diseases.
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Affiliation(s)
- Joon Hyun Cho
- Division of Gastroenterology and Hepatology, Department of Internal Medicine, Yeungnam University College of Medicine, Daegu, Korea
| | - Mohammad Bilal
- Center for Advanced Endoscopy, Division of Gastroenterology, Beth Israel Deaconess Medical Center, Harvard Medical School, Boston, MA, USA
| | - Min Cheol Kim
- Division of Gastroenterology and Hepatology, Department of Internal Medicine, Yeungnam University College of Medicine, Daegu, Korea
| | - Jonah Cohen
- Center for Advanced Endoscopy, Division of Gastroenterology, Beth Israel Deaconess Medical Center, Harvard Medical School, Boston, MA, USA
| | - The Study Group for Endoscopic Bariatric and Metabolic Therapies of the Korean Society of Gastrointestinal Endoscopy
- Division of Gastroenterology and Hepatology, Department of Internal Medicine, Yeungnam University College of Medicine, Daegu, Korea
- Center for Advanced Endoscopy, Division of Gastroenterology, Beth Israel Deaconess Medical Center, Harvard Medical School, Boston, MA, USA
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20
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Efficacy of Liraglutide to Prevent Weight Regain After Retrieval of an Adjustable Intra-gastric Balloon-a Case-Matched Study. Obes Surg 2020; 31:1204-1213. [PMID: 33211267 DOI: 10.1007/s11695-020-05117-8] [Citation(s) in RCA: 15] [Impact Index Per Article: 3.0] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Received: 06/16/2020] [Revised: 10/29/2020] [Accepted: 11/10/2020] [Indexed: 10/23/2022]
Abstract
PURPOSE Weight regain after balloon retrieval is a concern with all intra-gastric balloons (IGBs). The aim of this study was to evaluate the efficacy of liraglutide, a glucagon-like peptide-1 (GLP-1) agonist, to prevent weight regain following IGB retrieval. MATERIALS AND METHODS This was a case-matched study of patients undergoing Spatz3 adjustable IGB (Spatz FGIA, Inc. NY, USA) at three outpatient clinics in Brazil between November 2015 and January 2019. Seventy-seven patients that opted to take liraglutide following IGB retrieval (IGB-L) were matched 1:1 to 198 patients that declined the medication-IGB-Alone (IGB-A). Propensity score adjustment was performed at the time of balloon retrieval on factors known to influence the choice of liraglutide. Weight and percent body fat (%BF) was measured at baseline and 9 months after IGB retrieval. % BF is defined as the total mass of fat divided by total body mass, multiplied by 100. The primary outcome was weight regain, and the secondary outcome was change in %BF 9 months after IGB retrieval. RESULTS Propensity score matching yielded 53 matched pairs. Weight regain to the starting point was not observed in either group. There was significantly less weight regain in IGB-L compared to IGB-A, - 1.15 ± 0.94 kg versus - 0.66 ± 0.99 kg (p = 0.010) 9 months after balloon retrieval. Additionally, %BF decline in IGB-L was superior to IGB-A - 10.83 ± 1.50 versus - 7.94 ± 2.02 (p < 0.01). There was no difference in weight regain or decline in %BF based on liraglutide dose. CONCLUSION Liraglutide has an additive benefit with respect to efficacy and a reduction in body fat when commenced after IGB retrieval. Future randomized control studies will be needed to determine the optimal dose and duration of liraglutide to achieve superior outcomes.
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21
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Wu L, Dai X, Zhao W, Huang H, Mo L, Wu X. [Intragastric balloon for weight reduction: rationale, benefits, risks and indications]. NAN FANG YI KE DA XUE XUE BAO = JOURNAL OF SOUTHERN MEDICAL UNIVERSITY 2020; 40:1525-1529. [PMID: 33118505 DOI: 10.12122/j.issn.1673-4254.2020.10.21] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [Key Words] [Subscribe] [Scholar Register] [Indexed: 11/24/2022]
Abstract
Intragastric balloon (IGB) placement under endoscopy is a non-invasive method for weight loss.By placing a space-occupying balloon in the stomach, IGB treatment can achieve better effect of weight loss than medications.Herein we review the development of IGB, its effect on weight loss and the mechanism, and the eligible individuals for IGB treatment.We also examine the high-intensity postoperative management following IGB placement, which is important for maintaining long-term weight loss, and discuss the future development of IGB.The patients should understand that on the basis of ensuring a high safety, the weight-losing effect of IGB can be limited and relies heavily on postoperative management.Patients should make a decision on IGB placement after careful consideration of their own physical, economic, and psychological conditions, lifestyle and the line of work in addition to the indications of IGB.IGB placement combined with high-intensity postoperative management and active interventions of lifestyle and dietary habits help to achieve long-term effect of weight loss and improve obesity-related complications.
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Affiliation(s)
- Liangping Wu
- Surgical Center for Obesity and Diabetes, Jinshazhou Hospital, Guangzhou University of Chinese Medicine, Guangzhou 510168, China.,UDM Medical Group, Guangzhou 510168, China
| | - Xiaojiang Dai
- Surgical Center for Obesity and Diabetes, Jinshazhou Hospital, Guangzhou University of Chinese Medicine, Guangzhou 510168, China.,UDM Medical Group, Guangzhou 510168, China
| | - Weiguo Zhao
- Surgical Center for Obesity and Diabetes, Jinshazhou Hospital, Guangzhou University of Chinese Medicine, Guangzhou 510168, China.,UDM Medical Group, Guangzhou 510168, China
| | - Hongyan Huang
- Surgical Center for Obesity and Diabetes, Jinshazhou Hospital, Guangzhou University of Chinese Medicine, Guangzhou 510168, China.,UDM Medical Group, Guangzhou 510168, China
| | - Li Mo
- Surgical Center for Obesity and Diabetes, Jinshazhou Hospital, Guangzhou University of Chinese Medicine, Guangzhou 510168, China.,UDM Medical Group, Guangzhou 510168, China
| | - Xiaofeng Wu
- Surgical Center for Obesity and Diabetes, Jinshazhou Hospital, Guangzhou University of Chinese Medicine, Guangzhou 510168, China.,UDM Medical Group, Guangzhou 510168, China
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22
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Randomized Prospective Clinical Study of Spatz3® Adjustable Intragastric Balloon Treatment with a Control Group: a Large-Scale Brazilian Experiment. Obes Surg 2020; 31:787-796. [PMID: 33001381 DOI: 10.1007/s11695-020-05014-0] [Citation(s) in RCA: 8] [Impact Index Per Article: 1.6] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Received: 06/09/2020] [Revised: 09/24/2020] [Accepted: 09/24/2020] [Indexed: 12/16/2022]
Abstract
BACKGROUND To analyze the results regarding weight loss and complications related to the Spatz3® adjustable intragastric balloon (IGB) in Brazil. METHODS This randomized prospective study covered patients who had undergone treatment using a Spatz3® adjustable IGB between October 2016 and June 2018 at a private clinic in Rio de Janeiro, Brazil. The patients had a minimum body mass index (BMI) of 27 kg/m2. The study examined complications of Spatz3® treatment and BMI reduction, percentage of total weight loss (%TWL), and % of excess weight loss (%EWL). RESULTS One hundred eighty patients underwent a Spatz3® balloon implant in the period. The patients were randomly divided into one group in which the Spatz balloon was kept at the same volume (600 mL) throughout treatment (Control Group), and another adjustment group with 250 mL greater volume. The complication rate was 16.14%. No death or major complication occurred during the study. Mean BMI decreased from 39.51 to 32.84 kg/m2 (p < 0.0001), bodyweight from 111.87 to 90.28 kg (p < 0.0001), and excess weight from 41.55 to 22.99 kg (p < 0.0001). The adjustment resulted in greater mean weight loss of 4.35 kg (- 8 to 17.6 kg), and the average time of the procedure was 7.12 ± 1.63 months. The upward adjustment group did not present greater %TWL, %EWL, or BMI reduction when compared with the control group (p = 0.4413, p = 0,9245, p = 0.2729, respectively). CONCLUSION This study shows that Spatz3® IGB treatment is an effective procedure for weight reduction, with no mortality but higher morbidity compared with traditional IGBs. This procedure also enabled the balloon to stay in place for longer. The efficacy of upward adjustment still requires further confirmation.
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23
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Alqabandi O, Almutawa Y, AlTarrah D, Alhajeri M, Jamal MH, Almazeedi S. Intragastric balloon insertion and pancreatitis: Case series. Int J Surg Case Rep 2020; 74:263-267. [PMID: 32905925 PMCID: PMC7486575 DOI: 10.1016/j.ijscr.2020.08.043] [Citation(s) in RCA: 9] [Impact Index Per Article: 1.8] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Download PDF] [Figures] [Journal Information] [Subscribe] [Scholar Register] [Received: 07/25/2020] [Revised: 08/25/2020] [Accepted: 08/25/2020] [Indexed: 12/14/2022] Open
Abstract
INTRODUCTION Obesity is a complex multifactorial disease that affects populations worldwide. In Kuwait, the prevalence of obesity is a major public health problem. Intra-Gastric Balloon (IGB) is commonly used as a non-operative strategy among bariatric patients. However, with the increasing use of IGB, life-threatening adverse outcomes are widely reported. PRESENTATION OF CASES A case series five patients presenting with pancreatitis from IGB in Kuwait is reported to better investigate the emerging complications of IGB. Three types of IGB were inserted, these include the Orbera Intragastric Balloon System, Orbera365 Intragastric Balloon System, and the Spatz Adjustable Gastric. The clinical course of balloon pancreatitis is described. DISCUSSION The case series examined existing case reports of IGB associated pancreatitis in the literature, in addition to the investigated clinical outcomes. Patients presented with mild pancreatitis, and removal of balloon resulted in significant improvement in symptoms. Pathogenesis of balloon pancreatitis could be secondary to the pancreas compression by the IGB. CONCLUSION Despite the rarity of balloon pancreatitis, it needs to be recognized as a complication of IGB insertion. Further research is needed to better understand the implications of the balloon size, shape, volume and location of balloon insertion in order to prevent this fatal complication.
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Affiliation(s)
| | | | - Dana AlTarrah
- Faculty of Public Health, Kuwait University, Kuwait.
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24
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Brunaldi VO, Galvao Neto M. Gastric space-occupying devices for management of obesity and metabolic disease. ACTA ACUST UNITED AC 2020. [DOI: 10.1016/j.tige.2020.05.001] [Citation(s) in RCA: 2] [Impact Index Per Article: 0.4] [Reference Citation Analysis] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Indexed: 12/16/2022]
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Orlandini B, Gallo C, Boškoski I, Bove V, Costamagna G. Procedures and devices for bariatric and metabolic endoscopy. Ther Adv Gastrointest Endosc 2020; 13:2631774520925647. [PMID: 32548577 PMCID: PMC7271273 DOI: 10.1177/2631774520925647] [Citation(s) in RCA: 2] [Impact Index Per Article: 0.4] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Download PDF] [Figures] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Received: 11/07/2019] [Accepted: 04/21/2020] [Indexed: 12/14/2022] Open
Abstract
Obesity is a leading cause of preventable death in developed countries, with a
rising incidence over time. Lifestyle modification, pharmacotherapy, and
bariatric surgery are the mainstays of bariatric therapy, even though burdened
by several limitations in terms of efficacy or safety. Bariatric endoscopy has
been developed in the last decades as a minimally invasive alternative, aimed to
bridge the gap between conservative and interventional conventional therapies.
This review aims to provide an updated overview of the bariatric and metabolic
available endoscopic procedures and to drive the choice of the right procedure
for the right patient.
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Affiliation(s)
- Beatrice Orlandini
- Digestive Endoscopy Unit, Fondazione Policlinico Universitario Agostino Gemelli IRCCS, Rome, Italy
| | - Camilla Gallo
- Digestive Endoscopy Unit, Fondazione Policlinico Universitario Agostino Gemelli IRCCS, Rome, Italy
| | - Ivo Boškoski
- Digestive Endoscopy Unit, Fondazione Policlinico Universitario Agostino Gemelli IRCCS, Largo A. Gemelli, 8 00168 Rome, Italy
| | - Vincenzo Bove
- Digestive Endoscopy Unit, Fondazione Policlinico Universitario Agostino Gemelli IRCCS, Rome, Italy
| | - Guido Costamagna
- Digestive Endoscopy Unit, Fondazione Policlinico Universitario Agostino Gemelli IRCCS, Rome, Italy
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26
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Schwaab ML, Usuy EN, Albuquerque MMD, Moreira DM, Derossi VO, Usuy RT. ASSESSMENT OF WEIGHT LOSS AFTER NON-ADJUSTABLE AND ADJUSTABLE INTRAGASTRIC BALLOON USE. ARQUIVOS DE GASTROENTEROLOGIA 2020; 57:13-18. [PMID: 32294730 DOI: 10.1590/s0004-2803.202000000-04] [Citation(s) in RCA: 4] [Impact Index Per Article: 0.8] [Reference Citation Analysis] [Abstract] [Track Full Text] [Subscribe] [Scholar Register] [Received: 08/17/2019] [Accepted: 11/11/2019] [Indexed: 01/14/2023]
Abstract
BACKGROUND Intragastric balloon (IGB) use is indicated for patients whose BMI precludes the option of bariatric surgery or who need to lose weight prior to undergoing surgery. It is a minimally invasive procedure and currently there are two main models of IGBs in use, the non-adjustable intragastric balloon (NIB), implanted for six months, and the adjustable intragastric balloon (AIB), implanted for up to 12 months. OBJECTIVE Analyze clinical characteristics between patients receiving non-adjustable gastric balloon and the adjustable (prolonged implantation) intragastric balloon. METHODS This was a cross-sectional study of 470 patients diagnosed as obese or overweight who had balloon implantation from October 2011 to July 2018. The associations between percentage excess weight loss versus clinical and demographic variables were calculated using the chi-squared test. Independent samples were submitted to the Student's t test to determine the quantitative variables, with a confidence interval of 95%. Calculation of excess weight was based on an estimated ideal weight that would correspond to a BMI of 24.99 kg/m2. RESULTS A total of 414 patients completed the treatment achieving an average total body weight loss (%TBWL) of 15.4±7 with the NIB and 15.5±9.6 with the AIB. Overweight patients achieved higher excess weight loss (%EWL) values using AIBs (157.2±82.5) and obese patients did so with NIB use (56±29.7). Women achieved higher %EWL values (65.6±62.2) than men (48±27.1). Individuals who attended >4 consultations with a nutritionist (60.8%) achieved TBWL >18%. All of those P-values were <0.001. CONCLUSION Obese individuals and women registered the greatest weight losses. Overweight patients achieved greater losses using AIB and obese patients did so using NIBs. NIB use was associated with higher EWL percentages. Nutritional accompaniment had a positive impact on the %TBWL.
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Affiliation(s)
- Maíra L Schwaab
- Curso de Medicina da Universidade do Sul de Santa Catarina, Palhoça, SC, Brasil
| | | | | | | | - Victor O Derossi
- Curso de Medicina da Universidade do Sul de Santa Catarina, Palhoça, SC, Brasil
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27
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Genco A, Ienca R, Ernesti I, Maselli R, Casella G, Bresciani S, Mariani S, Soricelli E, Baglio G, Lorenzo M, Monti M. Improving Weight Loss by Combination of Two Temporary Antiobesity Treatments. Obes Surg 2019; 28:3733-3737. [PMID: 30173286 DOI: 10.1007/s11695-018-3448-9] [Citation(s) in RCA: 5] [Impact Index Per Article: 0.8] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Indexed: 01/06/2023]
Abstract
BACKGROUND It is generally accepted that the efficacy with an intragastric balloon decreases after the first 4 months of treatment. Aim of this study is to evaluate if the association of a very low-calorie ketogenic diet (VLCKD) can improve the results in terms of weight loss parameters and co-morbidities, as compared to usually prescribed low-calorie diet (LCD). METHODS For the present study (January 2016-June 2017), 80 patients (20 M/60 F, mean age 37.8 ± 6.1 years; excess weight 56 ± 10 kg; mean BMI 37.2 ± 3.8 kg/m2) underwent Orbera positioning. After 4 months, they were randomized into two groups according to the type of treatment: group A (Bioenterics intragastric balloon - Orbera + VLCKD) (n = 40), and group B (Orbera + LCD) (n = 40). RESULTS All patients completed the study with good adherence to diet therapy treatment allocation. After the 6-month treatment period, at time of Orbera removal, mean weight loss was 19 kg and 12 kg in groups A and B respectively (p < 0.05). Mean BMI was 28.9 ± 2.8 and 31.6 ± 3.1 kg/m2 (p < 0.05), and %EWL was 33.1 ± 3.3 and 21.1 ± 2.9 (p < 0.05) in groups A and B respectively. During the last 2 months in group A, the mean weight loss was 8 kg, while in Group B, the main weight loss was 3 kg (p < 0.001). The VLCKD treatment induced a more significant reduction of major comorbidities related to metabolic syndrome. CONCLUSIONS This study clearly indicates the efficacy of the prescription of very low-calorie ketogenic diet improving the efficacy of intragastric balloon positioning.
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Affiliation(s)
- Alfredo Genco
- Department of Surgical Sciences, Surgical Endoscopy Unit, La Sapienza University of Rome, Rome, Italy
| | - Roberta Ienca
- Department of Experimental Medicine-Medical Physiopathology, Food Science and Endocrinology Section, Sapienza University of Rome, Rome, Italy
| | - Ilaria Ernesti
- Department of Experimental Medicine-Medical Physiopathology, Food Science and Endocrinology Section, Sapienza University of Rome, Rome, Italy
| | | | - Giovanni Casella
- Department of Surgical Sciences, Surgical Endoscopy Unit, La Sapienza University of Rome, Rome, Italy
| | - Sabrina Bresciani
- Department of Experimental Medicine-Medical Physiopathology, Food Science and Endocrinology Section, Sapienza University of Rome, Rome, Italy
| | - Stefania Mariani
- Department of Experimental Medicine-Medical Physiopathology, Food Science and Endocrinology Section, Sapienza University of Rome, Rome, Italy
| | - Emanuele Soricelli
- Department of Surgical Sciences, Surgical Endoscopy Unit, La Sapienza University of Rome, Rome, Italy
| | - Giovanni Baglio
- Department of Surgical Sciences, Surgical Endoscopy Unit, La Sapienza University of Rome, Rome, Italy
| | | | - Massimo Monti
- Department of Surgical Sciences, Surgical Endoscopy Unit, La Sapienza University of Rome, Rome, Italy
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Abstract
BACKGROUND Intragastric balloons (IGBs) have demonstrated efficacy; however, the percent of "responders" (> 25% estimated weight loss (EWL) or > 10% total body weight loss (TBWL)-as suggested by FDA) have been less reported. The Spatz3 adjustable intragastric balloon (AIGB) extends implantation to 1 year, decreases balloon volume for intolerance, and increases volume for diminishing effect. AIM The aim of this study is to determine the efficacy/responder rate of the Spatz3 AIGB. METHODS Implantations of Spatz3 in 165 consecutive patients (pts) in 2 centers were retrospectively reviewed. Mean BMI is 35.7, mean weight (wt) 99.1 kg, and mean balloon volume 495 ml (400-600 ml). Balloon volume adjustments were offered for intolerance and for wt loss plateau. RESULTS In total, 165 pts were implanted yielding mean wt loss of 16.3 kg, 16.4% TBWL, and 67.4% EWL. Response (> 25% EWL; 10% TBWL) was achieved in 146/165 (88.5%) of patients. Response rates differed for 136 pts with BMI < 40 (91.2%) and 29 pts with BMI > 40 (69%). Down adjustments in 20 patients (mean - 150 ml) allowed 16/20 (80%) to continue IGB therapy. Up adjustments in 64 patients (mean 5.4 months; mean + 260 ml) yielded additional mean wt loss of 5.7 kg. One gastric perforation (0.6%) occurred in a patient who experienced abdominal pain for 2 weeks. Five patients with small ulcers did not require balloon extraction. CONCLUSIONS (1) Within the limitations of a retrospective review, the Spatz3 balloon appears to be an effective wt loss balloon with better response rates in BMI < 40. (2) Up adjustments yielded a mean 5.7 kg extra wt loss. (3) Down adjustments alleviated early intolerance in 80% of patients. (4) These two adjustment functions may be instrumental in yielding a responder rate of 88.5%.
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Abstract
OBJECTIVE. The purposes of this article are to familiarize radiologists with endoscopic techniques currently in use and to improve identification of clinically relevant imaging findings and procedural complications related to common endoscopic interventions. CONCLUSION. The frequency of performance of therapeutic endoscopic ultrasound-guided procedures has risen precipitously in the last decade. These procedures are replacing surgical and percutaneous approaches to a variety of disease entities. Recent advances include endoscopic bariatric procedures, endoscopic myotomies, and endoscopic ultrasound-guided drainage procedures.
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Chablaney S, Kumta NA. Endoscopic bariatric and metabolic therapies: Another tool for the management of diabetes and obesity. J Diabetes 2019; 11:351-358. [PMID: 30447101 DOI: 10.1111/1753-0407.12878] [Citation(s) in RCA: 1] [Impact Index Per Article: 0.2] [Reference Citation Analysis] [Abstract] [Key Words] [MESH Headings] [Track Full Text] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Received: 05/16/2018] [Revised: 10/25/2018] [Accepted: 11/13/2018] [Indexed: 01/25/2023] Open
Abstract
Endoscopic bariatric and metabolic therapies (EBMTs) have sparked significant interest as minimally invasive therapeutic options for weight loss. Although bariatric surgery remains an effective option for sustained weight loss and improvement in the metabolic syndrome, access and utilization are limited. Various EBMTs have been designed to emulate the physiologic effects of established surgical interventions, including space-occupying and non-space-occupying gastric therapies, gastric remodeling procedures, and small bowel therapies. This review discusses the safety and efficacy of available US Food and Drug Administration-approved minimally invasive endoscopic bariatric interventions, as well as those currently under investigation. In addition, the role of endoscopic revision after failed surgical intervention is discussed.
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Affiliation(s)
- Shreya Chablaney
- Dr. Henry D. Janowitz Division of Gastroenterology, Icahn School of Medicine at Mount Sinai, New York, New York
| | - Nikhil A Kumta
- Dr. Henry D. Janowitz Division of Gastroenterology, Icahn School of Medicine at Mount Sinai, New York, New York
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Turkeltaub JA, Edmundowicz SA. Endoscopic Bariatric Therapies: Intragastric Balloons, Tissue Apposition, and Aspiration Therapy. ACTA ACUST UNITED AC 2019; 17:187-201. [PMID: 30963378 DOI: 10.1007/s11938-019-00232-7] [Citation(s) in RCA: 14] [Impact Index Per Article: 2.3] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Indexed: 01/13/2023]
Abstract
PURPOSE OF REVIEW Endoscopic bariatric therapies (EBTs) have been identified as a group of procedures that can bridge the treatment gap between bariatric surgical procedures and non-procedural treatments such as pharmacotherapy and lifestyle therapy. We will review the recent progress that has been made in this important area in the past several years. RECENT FINDINGS Traditional intragastric balloons (IGB) that are both placed and removed endoscopically have been the fixture of IGB therapy. They have been shown to be safe and effective, when kept in place for 6 months. Newer IGBs, both currently FDA approved and those in clinical trials, have unique features. The Obalon gastric balloon system is gas filled and does not require endoscopy for placement. The Elipse balloon system that is in clinical trials neither requires endoscopy for placement nor removal. The Spatz3 balloon is in clinical trials and can be adjusted endoscopically by adding or subtracting volume to titrate balloon volume to symptoms and weight loss. In addition to IGBs, several other promising therapies have continued to evolve. Endoscopic sleeve gastroplasty (ESG) is a promising gastric restriction technique that has efficacy and durability. POSE is a gastric plication technique that is available in Europe and in clinical trials in the USA. Aspiration therapy is a novel approach to weight loss that requires patient compliance but can be very effective and used long term. EBTs are an evolving effective and safe approach for patients who do not qualify for or do not want bariatric surgery. There are multiple EBTs currently FDA approved as well as prospective endoscopic therapies in clinical trials that appear promising.
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Affiliation(s)
- Joshua A Turkeltaub
- Division of Gastroenterology and Hepatology, University of Colorado School of Medicine, University of Colorado Anschutz Medical Campus, 12631 E 17th Ave, MSB-158, Aurora, CO, 80045, USA.
| | - Steven A Edmundowicz
- Division of Gastroenterology and Hepatology, University of Colorado School of Medicine, University of Colorado Anschutz Medical Campus, 12631 E 17th Ave, MSB-158, Aurora, CO, 80045, USA.
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Abstract
OBJECTIVES To familiarize medical providers with the Food and Drug Administration approval process for antiobesity devices and to provide a brief overview of current and promising endoscopy-based bariatric devices. METHODS Literature review of published scholarly articles. RESULTS There has been a rapid development of novel endoscopic bariatric therapies in recent years, resulting in the approval of multiple devices. Several promising endoscopic strategies are currently under investigation and review. The Food and Drug Administration has laid down an objective-tiered model to review antiobesity device applications. DISCUSSION Endoscopic bariatric devices provide a new and promising paradigm in obesity management both as first-line therapy and as adjunctive treatment to medical and surgical strategies. Physicians who plan to offer endoscopic bariatric therapy in their practice need appropriate understanding of the regulatory processes involved in the development and approval of such devices.
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Espinet Coll E, López-Nava Breviere G, Nebreda Durán J, Marra-López Valenciano C, Turró Arau R, Esteban López-Jamar JM, Muñoz-Navas M. Spanish consensus document on bariatric endoscopy. Part 2: specific endoscopic treatments. REVISTA ESPANOLA DE ENFERMEDADES DIGESTIVAS 2019; 111:140-154. [PMID: 30654612 DOI: 10.17235/reed.2019.4922/2017] [Citation(s) in RCA: 4] [Impact Index Per Article: 0.7] [Reference Citation Analysis] [Abstract] [Track Full Text] [Subscribe] [Scholar Register] [Indexed: 11/20/2022]
Abstract
During the last years we have been witnessing a significant increase in the number and type of bariatric endoscopic techniques: we have different types of balloons, suture systems, injection of substances and malabsorptive prosthesis, etc. Also, some endoscopic revisional procedures for patients with weight regain after bariatric surgery have been incorporated. This makes it necessary to protocolize, position and regularize all these techniques, through a consensus that allows their clinical application with the maximum medical rigor and scientific evidence available.
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Haydara T, Kabel AM, Elsaka AM. The role of silent helicobacter pylori infection in intragastric ulcers induced by balloon insertion used for management of obesity. Diabetes Metab Syndr 2019; 13:116-121. [PMID: 30641681 DOI: 10.1016/j.dsx.2018.08.023] [Citation(s) in RCA: 2] [Impact Index Per Article: 0.3] [Reference Citation Analysis] [Abstract] [Key Words] [MESH Headings] [Track Full Text] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Received: 07/25/2018] [Accepted: 08/21/2018] [Indexed: 01/31/2023]
Abstract
BACKGROUND Obesity represents one of the common medical disorders that carries a high risk of morbidity and mortality. Insertion of intragastric balloon is one of the recently introduced lines of treatment of obesity. It allows patients to sense abdominal fullness and reduce their food intake. However, gastric ulceration may be a serious adverse effect that may be associated with intragastric balloon insertion. AIM To assess the role of silent helicobacter pylori infection in intragastric balloon-induced ulcers and to explore the possible methods for amelioration of this effect. METHODS Thirty patients were divided into 2 equal groups; one of them received triple therapy for helicobacter pylori eradication and the other group received placebo treatment. Then, they underwent intragastric balloon insertion. After removal of the balloon, gastroscopy was performed to evaluate the gastric mucosal lesions, if present. RESULTS There was significant decrease in the incidence of gastric erosions and ulcerations in the group that received triple therapy for helicobacter pylori eradication compared to the group that received placebo treatment. CONCLUSION Eradication of silent helicobacter pylori infection may represent a promising hope to decrease the incidence and improve symptoms of gastric erosions and ulceration that may be associated with intragastric balloon insertion.
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Affiliation(s)
- Tamer Haydara
- Internal Medicine Department, Faculty of Medicine, Kafrelsheikh University, Egypt
| | - Ahmed M Kabel
- Pharmacology Department, Faculty of Medicine, Tanta University, Tanta, Egypt; Department of Clinical Pharmacy, College of Pharmacy, Taif University, Taif, Saudi Arabia.
| | - Ayman M Elsaka
- Department of Pathology, Faculty of Medicine, Tanta University, Tanta, Egypt
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Dang JT, Switzer NJ, Sun WY, Raghavji F, Birch DW, Karmali S. Evaluating the safety of intragastric balloon: An analysis of the Metabolic and Bariatric Surgery Accreditation and Quality Improvement Program. Surg Obes Relat Dis 2018; 14:1340-1347. [PMID: 29934235 DOI: 10.1016/j.soard.2018.05.003] [Citation(s) in RCA: 13] [Impact Index Per Article: 1.9] [Reference Citation Analysis] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Received: 02/12/2018] [Revised: 04/26/2018] [Accepted: 05/05/2018] [Indexed: 02/08/2023]
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Choi SJ, Choi HS. Various Intragastric Balloons Under Clinical Investigation. Clin Endosc 2018; 51:407-415. [PMID: 30257544 PMCID: PMC6182294 DOI: 10.5946/ce.2018.140] [Citation(s) in RCA: 17] [Impact Index Per Article: 2.4] [Reference Citation Analysis] [Abstract] [Key Words] [Grants] [Track Full Text] [Download PDF] [Figures] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Received: 08/16/2018] [Revised: 09/17/2018] [Accepted: 09/17/2018] [Indexed: 12/21/2022] Open
Abstract
Obesity is a chronic disease with an exponentially increasing incidence rate, and its negative effects are well documented in numerous studies. As a result, the importance of bariatric therapy cannot be overemphasized, and many bariatric treatment methods with varying mechanisms have been developed. Of the available treatment methods, intragastric balloons, introduced in the 1980s, have been shown to be a safe and effective treatment modality; various intragastric balloon products have been developed and are currently being widely used in clinical settings. However, the disadvantages of intragastric balloons, such as unclear long-term weight loss benefits and complications experienced during insertion and removal, preclude their wider use. In this review, we discuss different intragastric balloon products, focusing on those under clinical investigation, and suggest future research directions.
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Affiliation(s)
- Seong Ji Choi
- Division of Gastroenterology and Hepatology, Department of Internal Medicine, Institute of Gastrointestinal Medical Instrument Research, Korea University College of Medicine, Seoul, Korea
| | - Hyuk Soon Choi
- Division of Gastroenterology and Hepatology, Department of Internal Medicine, Institute of Gastrointestinal Medical Instrument Research, Korea University College of Medicine, Seoul, Korea
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Abstract
PURPOSE This study was carried out because intragastric balloon (IGB) is a widely used method to combat obesity, and acute pancreatitis complicating IGB is rare and yet to be understood. METHOD This study was a retrospective analysis of all patients with a history of IGB insertion, who developed acute pancreatitis before balloon removal. RESULTS A total of 4 cases were found, with a mean age of 27±2.9 years. The mean duration of IGB insertion was 2.25±1.25 months, with an average body mass index of 37.7±3.4 kg/m. Abdominal computed tomography visualized signs of pancreatitis with the balloon compressing the pancreatic body. Pancreatitis resolved after endoscopic balloon extraction, with an average aspiration of 607.5±64.5 mL of the fluid used to fill the balloon. CONCLUSION Our study demonstrates that acute pancreatitis can complicate IGB and recommends the need to measure amylase and lipase in patients who have a history of IGB insertion and present with a picture suggestive of pancreatitis.
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Abstract
Obesity is a global health problem which is on the rise and is strongly associated with the development of type 2 diabetes and other comorbidities. Bariatric surgery is now an established treatment for both these conditions, leading to impressive results in weight loss and glycemic control. More recently, we have seen the development of various endoscopic devices as potential alternatives or adjuncts to bariatric surgery. In this state-of-the-art review, we outline the current landscape of endoscopic treatments available for the management of both obesity and diabetes, including the clinical evidence supporting their use, efficacy, safety, and potential mechanisms of action.
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Abstract
PURPOSE OF REVIEW In this review, we describe the FDA-approved and investigational devices and endoscopic bariatric therapies for the treatment of obesity. We focus on literature published in the past few years and present mechanisms of action as well as efficacy and safety data. RECENT FINDINGS Devices and endoscopic procedures are emerging options to fill the significant treatment gap in the management of obesity. Not only are these devices and procedures minimally invasive and reversible, but they are potentially more effective than antiobesity medications, often safer for poor surgical candidates and possibly less expensive than bariatric surgery. As many patients require a variety of management strategies (medications, devices, procedures, and/or surgery) in addition to lifestyle modifications to achieve clinically significant weight loss, the future of obesity treatment involves a multidisciplinary approach. Combinations of advanced treatment strategies can lead to additive or synergistic weight loss. This is an area that requires further investigation.
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Affiliation(s)
- Katherine H Saunders
- Comprehensive Weight Control Center, Division of Endocrinology, Diabetes and Metabolism, Weill Cornell Medicine, 1165 York Avenue, New York, NY, 10065, USA.
| | - Leon I Igel
- Comprehensive Weight Control Center, Division of Endocrinology, Diabetes and Metabolism, Weill Cornell Medicine, 1165 York Avenue, New York, NY, 10065, USA
| | - Monica Saumoy
- Divison of Gastroenterology and Hepatology, Weill Cornell Medicine, 1305 York Avenue, 4th Floor, New York, NY, 10021, USA
| | - Reem Z Sharaiha
- Divison of Gastroenterology and Hepatology, Weill Cornell Medicine, 1305 York Avenue, 4th Floor, New York, NY, 10021, USA
| | - Louis J Aronne
- Comprehensive Weight Control Center, Division of Endocrinology, Diabetes and Metabolism, Weill Cornell Medicine, 1165 York Avenue, New York, NY, 10065, USA
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Kurian M, Kroh M, Chand B, Mikami D, Reavis K, Khaitan L. SAGES review of endoscopic and minimally invasive bariatric interventions: a review of endoscopic and non-surgical bariatric interventions. Surg Endosc 2018; 32:4063-4067. [PMID: 29845397 DOI: 10.1007/s00464-018-6238-5] [Citation(s) in RCA: 7] [Impact Index Per Article: 1.0] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Received: 01/14/2018] [Accepted: 05/09/2018] [Indexed: 12/11/2022]
Abstract
BACKGROUND With obesity continuing as a global epidemic and therapeutic technologies advancing, several novel endoscopic and minimally invasive interventions will likely become available as treatment options. With improved technologies and different treatment strategies, as well as different patient populations being targeted, there will be greater application in the treatment armamentarium of specialists dedicated to treating obesity. We sought to review the existing technology and provide a review. METHODS Literature review was carried out for endoscopic and minimally invasive devices. Some of these products are not FDA approved, so limited data are available in their review. RESULTS A summary of the device and data currently available on weight loss and safety profile is provided. Several products are in clinical trials or will be soon. Some of the technology has limited data and companies will be submitting their results for FDA evaluation. CONCLUSIONS The obesity epidemic and associated weight-related diseases represent a tremendous burden to health care practitioners. As such, a multi-modal and progressive approach, with data and outcomes examined, is likely the best and most comprehensive method to care for these patients. SAGES endorses the benefits of minimally invasive and endoscopic approaches in the treatment of obesity and its related co-morbidities.
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Affiliation(s)
- Marina Kurian
- Department of Surgery, NYU Langone Medical Center, New York, NY, 10016, USA.
| | - Matthew Kroh
- Department of Surgery, Cleveland Clinic Abu Dhabi, Abu Dhabi, United Arab Emirates
| | - Bipan Chand
- Department of Surgery, Loyola University, Stritch School of Medicine, Maywood, IL, USA
| | - Dean Mikami
- Department of Surgery, University of Hawaii, Honolulu, HI, USA
| | - Kevin Reavis
- The Oregon Clinic; Legacy Weight & Diabetes Institute, Portland, OR, USA
| | - Leena Khaitan
- Department of Surgery, University Hospitals, Cleveland, OH, USA
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Espinet Coll E, Nebreda Durán J, López-Nava Breviere G, Ducóns García J, Rodríguez-Téllez M, Crespo García J, Marra-López Valenciano C. Multicenter study on the safety of bariatric endoscopy. REVISTA ESPANOLA DE ENFERMEDADES DIGESTIVAS 2018; 109:350-357. [PMID: 28301947 DOI: 10.17235/reed.2017.4499/2016] [Citation(s) in RCA: 7] [Impact Index Per Article: 1.0] [Reference Citation Analysis] [Abstract] [Track Full Text] [Subscribe] [Scholar Register] [Indexed: 01/03/2023]
Abstract
INTRODUCTION Bariatric endoscopy includes a series of specific techniques focused on the management of obese patients. As a quality criterion, safety as expressed by a minimal incidence of serious complications is required in addition to efficacy. METHODS A descriptive, retrospective, multicenter review of the experience recorded at seven hospitals included in the Grupo Español de Endoscopia Bariátrica (GETTEMO) in order to document the incidence, cause, and resolution (including legal consequences) of serious complications reported for each bariatric technique, and according to endoscopist expertise. RESULTS In all, 6,771 bariatric endoscopic procedures were collected, wherein 57 serious complications (0.84%) were identified. Balloons: Orbera®-Medsil®, 5/5,589; Spatz2® (older model): 44/225; Heliosphere®: 1/70; Obalon®: 0/107. Sutures: POSE®, 5/679; sleeve gastroplasty with Apollo® system: 0/55. Prostheses: Endobarrier®: 2/46. All complications were resolved with medical/endoscopic management except for five cases (0.07%) that required surgery. A single lawsuit occurred (esophageal perforation with Spatz2® balloon), which had a favorable outcome. There was no mortality, and apparently no differences were found according to endoscopist expertise level. CONCLUSIONS In our multicenter experience, bariatric endoscopy may be considered as a safe procedure (0.84% of serious complications in all). However, some devices may induce a higher proportion of complications, such as 19.55% for Spatz2® balloons (already replaced) or 4.34% for Endobarrier® sleeves (at the upper limit of accepted safety), although our experience with the latter is limited. All complications were resolved with conservative medical management, and only exceptionally required surgery (0.07%). No technique-related mortality was seen, and only one lawsuit occurred. Further evolutionary studies are required on the novel endoscopic techniques presently emerging to authenticate our results.
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Keren D, Rainis T. Intragastric Balloons for Overweight Populations—1 Year Post Removal. Obes Surg 2018; 28:2368-2373. [DOI: 10.1007/s11695-018-3167-2] [Citation(s) in RCA: 12] [Impact Index Per Article: 1.7] [Reference Citation Analysis] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Indexed: 12/20/2022]
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Granek RJ, Hii MW, Ward SM. Major Gastric Haemorrhage After Intragastric Balloon Insertion: Case Report. Obes Surg 2017; 28:281-284. [DOI: 10.1007/s11695-017-2988-8] [Citation(s) in RCA: 3] [Impact Index Per Article: 0.4] [Reference Citation Analysis] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Indexed: 01/20/2023]
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Hill C, Khashab MA, Kalloo AN, Kumbhari V. Endoluminal weight loss and metabolic therapies: current and future techniques. Ann N Y Acad Sci 2017; 1411:36-52. [PMID: 28884820 DOI: 10.1111/nyas.13441] [Citation(s) in RCA: 18] [Impact Index Per Article: 2.3] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Received: 03/22/2017] [Revised: 06/18/2017] [Accepted: 06/28/2017] [Indexed: 12/18/2022]
Abstract
Obesity is a public health epidemic associated with a number of comorbidities, most notably type 2 diabetes and hypertension, as well as elevated all-cause mortality. The treatment for obesity and its associated comorbidities has most recently expanded into the field of bariatric endoscopy. This field bridges a gap between lifestyle counseling with or without pharmaceutical treatment and the most effective treatment of obesity, bariatric surgery. Because of its minimally invasive nature, bariatric endoscopic therapy has the potential to appeal to the large sector of the obese population that resists surgery, as well as those early in the onset of obesity. To date, five endoscopic devices have been approved by the U.S. Food and Drug Administration for the treatment of obesity, and many more are in development, undergoing clinical trials, or being used around the world. Here, we present the current state of the field, highlight recent developments, and describe the clinical outcomes of these minimally invasive procedures in terms of weight loss, improvement in metabolic profile, and reduction in comorbidities.
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Affiliation(s)
- Christine Hill
- Diversity Summer Internship Program, Bloomberg School of Public Health, Johns Hopkins University, Baltimore, Maryland
| | - Mouen A Khashab
- Division of Gastroenterology and Hepatology, Johns Hopkins Medicine, Baltimore, Maryland
| | - Anthony N Kalloo
- Division of Gastroenterology and Hepatology, Johns Hopkins Medicine, Baltimore, Maryland
| | - Vivek Kumbhari
- Division of Gastroenterology and Hepatology, Johns Hopkins Medicine, Baltimore, Maryland
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Abstract
PURPOSE OF REVIEW This review aims to present the current state of the field, highlight recent developments, and describe the clinical outcomes of these endoscopic bariatric and metabolic procedures. RECENT FINDINGS There are an increasing number of devices and techniques that are available for the endoluminal treatment of obesity. It is now possible to offer FDA approved endoscopic therapies for patients with BMI as high as 55 kg/m. Although tremendous advances have been made, there is room for additional emphasis with regards to the metabolic improvements seen with these therapies, in addition to highlighting weight loss outcomes. Furthermore, for optimal outcomes, it is imperative that all endoluminal techniques are combined with at least a moderate intensity diet and lifestyle intervention for a minimum of 12 months. SUMMARY This field bridges a gap between lifestyle counseling with or without pharmaceutical treatment and the most effective treatment of obesity, bariatric surgery. Owing to its minimally invasive nature, endoscopic metabolic and bariatric therapy has the potential to appeal patients who either do not qualify or do not want bariatric surgery and have not been adequately treated with medical therapy. In addition, these therapies may be beneficial early on in the onset of obesity.
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Abstract
Obesity is a major public health concern that leads to numerous metabolic, mechanical and psychological complications. Although lifestyle interventions are the cornerstone of obesity management, subsequent physiological neurohormonal adaptations limit weight loss, strongly favour weight regain and counteract sustained weight loss. A range of effective therapies are therefore needed to manage this chronic relapsing disease. Bariatric surgery delivers substantial, durable weight loss but limited access to care, perceived high risks and costs restrict uptake. Medical devices are uniquely positioned to bridge the gap between more conservative lifestyle intervention and weight-loss pharmacotherapy and more disruptive bariatric surgery. In this Review, we examine the range of gastrointestinal medical devices that are available in clinical practice to treat obesity, as well as those that are in advanced stages of development. We focus on the mechanisms of action as well as the efficacy and safety profiles of these devices. Many of these devices are placed endoscopically, which provides gastroenterologists with exciting opportunities for treatment.
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47
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Çaycı H, Erdogdu UE. Laparoscopic sleeve gastrectomy versus endoscopical intra-gastric balloon placement: early results of morbidly obese patients. ARCHIVES OF CLINICAL AND EXPERIMENTAL MEDICINE 2017. [DOI: 10.25000/acem.324199] [Citation(s) in RCA: 3] [Impact Index Per Article: 0.4] [Reference Citation Analysis] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Indexed: 11/23/2022] Open
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Filling the Void: A Review of Intragastric Balloons for Obesity. Dig Dis Sci 2017; 62:1399-1408. [PMID: 28421456 DOI: 10.1007/s10620-017-4566-2] [Citation(s) in RCA: 27] [Impact Index Per Article: 3.4] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Received: 07/13/2016] [Accepted: 04/01/2017] [Indexed: 12/17/2022]
Abstract
Endoscopic bariatric therapies are predicted to become much more widely used in North America for obese patients who are not candidates for bariatric surgery. Of all the endoscopic bariatric therapies, intragastric balloons (IGBs) have the greatest amount of clinical experience and published data supporting their use. Three IGBs are FDA approved and are now commercially available in the USA (Orbera, ReShape Duo, and Obalon) with others likely soon to follow. They are generally indicated for patients whose BMI ranges from 30 to 40 mg/kg2 and who have failed to lose weight with diet and exercise. IGBs have been shown to be safe, effective, and relatively straightforward to place and remove. Accommodative symptoms commonly occur within the initial weeks post-placement; however, major complications are rare. Gastric ulceration can occur in up to 10% of patients, while balloon deflation with migration and bowel obstruction occurs in <1% of patients. The effectiveness of the Orbera and ReShape Duo IGBs ranges from 25 to 50% EWL (excess weight loss) after 6 months of therapy. The use of IGBs is likely to grow dramatically in the USA, and gastroenterologists and endoscopists should be familiar with their indications/contraindications, efficacy, placement/removal, and complications.
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Sullivan S, Edmundowicz SA, Thompson CC. Endoscopic Bariatric and Metabolic Therapies: New and Emerging Technologies. Gastroenterology 2017; 152:1791-1801. [PMID: 28192103 DOI: 10.1053/j.gastro.2017.01.044] [Citation(s) in RCA: 104] [Impact Index Per Article: 13.0] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Received: 10/27/2016] [Revised: 01/03/2017] [Accepted: 01/09/2017] [Indexed: 12/14/2022]
Abstract
Endoscopic bariatric and metabolic therapies (EBMT) are a new addition to the treatment arsenal for obesity. These include devices that are placed or removed via flexible endoscopy, and procedures that utilize instruments that require flexible endoscopy for the indications of weight loss or treatment of glucose intolerance (from pre-diabetes to diabetes). The EBMTs are generally divided into gastric and small bowel categories, and although individual EBMTs may have unique mechanisms of action, similar themes in proposed mechanism of action are seen in the gastric and small bowel EBMTs, respectively. In this review we will describe the therapies approved for use in the United States or currently in the process of obtaining approval for use in the United States. We will discuss potential mechanisms of action and examine safety and efficacy data.
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Affiliation(s)
- Shelby Sullivan
- Division of Gastroenterology, University of Colorado School of Medicine, Aurora, Colorado.
| | - Steven A Edmundowicz
- Division of Gastroenterology, University of Colorado School of Medicine, Aurora, Colorado
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50
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Abstract
Cost-effective therapies to address the growing epidemic of obesity are a leading priority in modern medicine. Intragastric balloons (IGBs) are one such option, with increased effectiveness compared with pharmacotherapy and lifestyle and a lower rate of adverse events than bariatric surgery. IGBs are endoscopically placed or swallowed space-occupying devices in the stomach. Three IGB systems were approved in 2015 to 2016 by the Food and Drug Administration for use in the United States, with more devices nearing approval. This paper reviews the adverse events and efficacy of IGBs, and practice setup, management of common complications, and dietary advice for patients.
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