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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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Goodman MC, Chang P, Minteer W, Nguyen D, Gopalkrishnan K, Phan J. Patient Complications and Device Issues Associated With FDA-Approved Intragastric Balloons Available in the USA: A Maude Database Study. Obes Surg 2024; 34:1971-1974. [PMID: 38467899 PMCID: PMC11031455 DOI: 10.1007/s11695-024-07128-1] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Key Words] [MESH Headings] [Grants] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Received: 11/30/2023] [Revised: 02/19/2024] [Accepted: 02/22/2024] [Indexed: 03/13/2024]
Affiliation(s)
- Morgan C Goodman
- Division of Gastrointestinal and Liver Diseases, Keck School of Medicine of the University of Southern California, Los Angeles, CA, USA.
| | - Patrick Chang
- Division of Gastrointestinal and Liver Diseases, Keck School of Medicine of the University of Southern California, Los Angeles, CA, USA
| | - William Minteer
- Division of Gastrointestinal and Liver Diseases, Keck School of Medicine of the University of Southern California, Los Angeles, CA, USA
| | - Denis Nguyen
- Department of Medicine, Keck School of Medicine of the University of Southern California, Los Angeles, CA, USA
| | - Kalpana Gopalkrishnan
- Department of Medicine, Keck School of Medicine of the University of Southern California, Los Angeles, CA, USA
| | - Jennifer Phan
- Division of Gastrointestinal and Liver Diseases, Keck School of Medicine of the University of Southern California, Los Angeles, CA, USA
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Dave N, Dawod E, Simmons OL. Endobariatrics: a Still Underutilized Weight Loss Tool. CURRENT TREATMENT OPTIONS IN GASTROENTEROLOGY 2023; 21:172-184. [PMID: 37284352 PMCID: PMC10163575 DOI: 10.1007/s11938-023-00420-6] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Figures] [Subscribe] [Scholar Register] [Accepted: 03/08/2023] [Indexed: 06/08/2023]
Abstract
Purpose of review Bariatric and metabolic endoscopic therapies provide an option for patients seeking clinically significant weight loss with fewer adverse events than conventional bariatric surgery. Our aims are to provide an overview of the current state of primary endoscopic treatment options for weight loss and to emphasize the importance of including these therapies when presenting weight loss options to qualified patients. Recent findings Bariatric endoscopy procedures are associated with a lower adverse event rate when compared to bariatric surgery and result in more weight loss than most existing pharmacotherapies approved by the Food and Drug Administration. Summary Sufficient evidence exists to implement bariatric endoscopic therapies-namely, the intragastric balloon and endoscopic sleeve gastroplasty-as safe and effective treatment options for weight loss when used in combination with lifestyle changes. However, bariatric endoscopy remains an underutilized option by weight management providers. Future studies are needed to identify patient and provider-level barriers to adopting endoscopic bariatric therapies as an option for the treatment of obesity.
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Affiliation(s)
- Niel Dave
- Division of Gastroenterology at HCA Florida Aventura Hospital, 20900 Biscayne Blvd, Aventura, FL 33180 USA
| | - Enad Dawod
- Division of Gastroenterology, Weill Cornell Medicine, New York Presbyterian Hospital, 1305 York Avenue, 4th Floor, New York, NY 10021 USA
| | - Okeefe L. Simmons
- Simmons MD Advanced Weight Loss Solutions, 2820 NE 214th Street, Suite 1002, Miami, FL 33180 USA
- Division of Gastroenterology, Miami Veterans Affairs Healthcare System, 1201 NW 16th Street, Miami, FL 33125 USA
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Mapping of Intragastric Balloon Use: a Guide to the Activity of Institutions Through Bibliometry. Obes Surg 2022; 32:2373-2385. [PMID: 35501633 DOI: 10.1007/s11695-022-06089-7] [Citation(s) in RCA: 2] [Impact Index Per Article: 0.7] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Received: 03/08/2022] [Revised: 04/26/2022] [Accepted: 04/26/2022] [Indexed: 10/18/2022]
Abstract
BACKGROUND Bibliometric analysis is an effective method for measuring scientific contributions in a variety of fields. It enables the numerical analysis of publications in a specific field and period of time, as well as the relationships between these publications. The present bibliometric analysis of publications relating to obesity treatment by means of intragastric balloons aimed to identify the bariatric centers using intragastric balloons, through the publications relating to their productivity; and furthermore, to reveal collaborations, types of balloons used, number of patients involved, and authors' productivity and favored journals. METHOD The PubMed and Scopus databases were used to retrieve only original articles presenting the results in body weight reduction. RESULTS Bibliographic research identified 164 publications for the period 2000-2021. Italy was ranked first with 37 publications; USA participated as collaborator with 9 different countries; the fluid-filled Orbera balloon is featured in 126 publications; the journal Obesity Surgery hosted 86 publications; Brazil reported the greatest number of patients with 5874 cases; Lorenzo M and Genco A, co-authors from Italy, authored 14 and 12 publications, respectively, and the most cited article was that of Genco et al. [2007] with 441 citations. CONCLUSIONS Bibliometric analysis gave us the opportunity to identify the centers through their scientific publications and to classify them in relation to their productivity in articles, in collaborations, in number of cases reported, and in the number of citations gained.
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Naringrekar HV, Shahid H, Varghese C, Schlachterman A, Deshmukh SP, Roth CG. Extrapancreatic Advanced Endoscopic Interventions. Radiographics 2022; 42:379-396. [PMID: 35089818 DOI: 10.1148/rg.210087] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Indexed: 11/11/2022]
Abstract
As the field of interventional endoscopy advances, conditions that were once treated with surgery are increasingly being treated with advanced endoscopy. Endoscopy is now used for treatment of achalasia, bariatric procedures for obesity; resection of early-stage malignancies in the gastrointestinal tract; and placement of lumen-apposing metal stents in the treatment of biliary obstruction, gastric outlet obstruction, cholecystitis, and drainage of nonpancreatic-related fluid collections or abscesses. Knowledge of the novel terminology, procedural details, expected postintervention imaging findings, and potential complications is vital for radiologists because these procedures are rapidly becoming more mainstream in daily practice. These procedures include peroral endoscopic myotomy for the treatment of achalasia and other esophageal motility disorders; endoscopic sleeve gastroplasty and placement of an intragastric balloon for weight loss; endoscopic submucosal dissection in the resection of tumors of the gastrointestinal tract; and therapeutic endoscopic-guided procedures for the treatment of biliary obstruction, gastric outlet obstruction, acute cholecystitis, and drainage of nonpancreatically related fluid collections. Patients benefit from these minimally invasive procedures, with potential improvement in morbidity and mortality rates, decreased length of hospital stay, and decreased health care costs when compared with the surgical alternative. Complications of these procedures include leaks or perforations, infections or abscesses, fistulas, and occlusion and migration of stents. An invited commentary by Pisipati and Pannala is available online. ©RSNA, 2022.
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Affiliation(s)
- Haresh Vijay Naringrekar
- From the Department of Radiology (H.V.N., S.P.D., C.G.R.) and Department of Gastroenterology and Hepatology (A.S.), Thomas Jefferson University Hospital, 132 S 10th St, Philadelphia, PA 19123; Division of Gastroenterology and Hepatology, Rutgers-Robert Wood Johnson Medical School, New Brunswick, NJ (H.S.); and Department of Radiology, Westchester Medical Center, Valhalla, NY (C.V.)
| | - Haroon Shahid
- From the Department of Radiology (H.V.N., S.P.D., C.G.R.) and Department of Gastroenterology and Hepatology (A.S.), Thomas Jefferson University Hospital, 132 S 10th St, Philadelphia, PA 19123; Division of Gastroenterology and Hepatology, Rutgers-Robert Wood Johnson Medical School, New Brunswick, NJ (H.S.); and Department of Radiology, Westchester Medical Center, Valhalla, NY (C.V.)
| | - Cyril Varghese
- From the Department of Radiology (H.V.N., S.P.D., C.G.R.) and Department of Gastroenterology and Hepatology (A.S.), Thomas Jefferson University Hospital, 132 S 10th St, Philadelphia, PA 19123; Division of Gastroenterology and Hepatology, Rutgers-Robert Wood Johnson Medical School, New Brunswick, NJ (H.S.); and Department of Radiology, Westchester Medical Center, Valhalla, NY (C.V.)
| | - Alex Schlachterman
- From the Department of Radiology (H.V.N., S.P.D., C.G.R.) and Department of Gastroenterology and Hepatology (A.S.), Thomas Jefferson University Hospital, 132 S 10th St, Philadelphia, PA 19123; Division of Gastroenterology and Hepatology, Rutgers-Robert Wood Johnson Medical School, New Brunswick, NJ (H.S.); and Department of Radiology, Westchester Medical Center, Valhalla, NY (C.V.)
| | - Sandeep P Deshmukh
- From the Department of Radiology (H.V.N., S.P.D., C.G.R.) and Department of Gastroenterology and Hepatology (A.S.), Thomas Jefferson University Hospital, 132 S 10th St, Philadelphia, PA 19123; Division of Gastroenterology and Hepatology, Rutgers-Robert Wood Johnson Medical School, New Brunswick, NJ (H.S.); and Department of Radiology, Westchester Medical Center, Valhalla, NY (C.V.)
| | - Christopher G Roth
- From the Department of Radiology (H.V.N., S.P.D., C.G.R.) and Department of Gastroenterology and Hepatology (A.S.), Thomas Jefferson University Hospital, 132 S 10th St, Philadelphia, PA 19123; Division of Gastroenterology and Hepatology, Rutgers-Robert Wood Johnson Medical School, New Brunswick, NJ (H.S.); and Department of Radiology, Westchester Medical Center, Valhalla, NY (C.V.)
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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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Zou ZY, Zeng J, Ren TY, Shi YW, Yang RX, Fan JG. Efficacy of Intragastric Balloons in the Markers of Metabolic Dysfunction-associated Fatty Liver Disease: Results from Meta-analyses. J Clin Transl Hepatol 2021; 9:353-363. [PMID: 34221921 PMCID: PMC8237142 DOI: 10.14218/jcth.2020.00183] [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: 12/27/2020] [Revised: 02/25/2021] [Accepted: 03/01/2021] [Indexed: 12/21/2022] Open
Abstract
BACKGROUND AND AIMS Nonalcoholic fatty liver disease, now renamed metabolic dysfunction-associated fatty liver disease (MAFLD), is common in obese patients. Intragastric balloon (IGB), an obesity management tool with low complication risk, might be used in MAFLD treatment but there is still unexplained heterogeneity in results across studies. METHODS We conducted a systematic search of 152 citations published up to September 2020. Meta-analyses, stratified analyses, and meta-regression were performed to evaluate the efficacy of IGB on homeostasis model assessment of insulin resistance (HOMA-IR), alanine aminotransferase (ALT), aspartate aminotransferase (AST), and gamma-glutamyl transpeptidase (GGT), and to identify patients most appropriate for IGB therapy. RESULTS Thirteen observational studies and one randomized controlled trial met the inclusion criteria (624 participants in total). In the overall estimate, IGB therapy significantly improved the serum markers change from baseline to follow-up [HOMA-IR: 1.56, 95% confidence interval (CI)=1.16-1.95; ALT: 11.53 U/L, 95% CI=7.10-15.96; AST: 6.79 U/L, 95% CI=1.69-11.90; GGT: 10.54 U/L, 95% CI=6.32-14.75]. In the stratified analysis, there were trends among participants with advanced age having less change in HOMA-IR (1.07 vs. 1.82). The improvement of insulin resistance and liver biochemistries with swallowable IGB therapy was no worse than that with endoscopic IGB. Multivariate meta-regression analyses showed that greater HOMA-IR loss was predicted by younger age (p=0.0107). Furthermore, effectiveness on ALT and GGT was predicted by basal ALT (p=0.0004) and GGT (p=0.0026), respectively. CONCLUSIONS IGB is effective among the serum markers of MAFLD. Younger patients had a greater decrease of HOMA-IR after IGB therapy.
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Affiliation(s)
| | | | | | | | | | - Jian-Gao Fan
- Correspondence to: Jian-Gao Fan, Center for Fatty Liver, Department of Gastroenterology, Xin Hua Hospital Affiliated to Shanghai Jiao Tong University School of Medicine, Shanghai Key Lab of Pediatric Gastroenterology and Nutrition, Shanghai 200092, China. ORCID: https://orcid.org/0000-0001-7443-5056. Tel: +86-21-2507-7340, Fax: +86-21-2507-7340, E-mail:
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Ramai D, Bhandari P, Facciorusso A, Barakat M, Pasisnichenko Y, Saghir S, Ambrosi A, Tartaglia N, Chandan S, Dhindsa B, Dhaliwal A, McDonough S, Adler DG. Real-World Experience of Intragastric Balloons for Obesity: Insights from the FDA Manufacturer and User Facility Device Experience (MAUDE) Database. Obes Surg 2021; 31:3360-3364. [PMID: 33687626 DOI: 10.1007/s11695-021-05324-x] [Citation(s) in RCA: 4] [Impact Index Per Article: 1.0] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Received: 01/05/2021] [Revised: 02/18/2021] [Accepted: 02/23/2021] [Indexed: 01/22/2023]
Abstract
Intragastric balloons have been used to bridge the obesity treatment gap. We aim to investigate the number and type of complications associated with intragastric balloons using public-access governmental databanks. We analyzed post-marketing surveillance data from the FDA Manufacturer and User Facility Device Experience (MAUDE) database from Jan 2017 through Nov 2020. During the study period, approximately 773 cases with 830 device issues and 1134 patient complications were identified. Most balloon complications were due to leaks (33.4%). The most reported adverse events were vomiting (26.6%), abdominal pain (25.3%), and nausea (15.8%). Findings from the MAUDE database highlight patient and device adverse outcomes that should be addressed to improve clinical success.
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Affiliation(s)
- Daryl Ramai
- Department of Internal Medicine, The Brooklyn Hospital Center, Brooklyn, NY, USA
| | - Peter Bhandari
- Department of Internal Medicine, The Brooklyn Hospital Center, Brooklyn, NY, USA
| | - Antonio Facciorusso
- Department of Medical Sciences, Section of Gastroenterology, University of Foggia, 71122, Foggia, Italy
| | - Mohamed Barakat
- Division of Gastroenterology, The Brooklyn Hospital Center, Brooklyn, NY, USA
| | - Yuriy Pasisnichenko
- Department of Internal Medicine, The Brooklyn Hospital Center, Brooklyn, NY, USA
| | - Syed Saghir
- Department of Medicine, University of Nevada, Las Vegas, NV, USA
| | - Antonio Ambrosi
- Department of Surgery, University of Foggia, 71122, Foggia, Italy
| | - Nicola Tartaglia
- Department of Surgery, University of Foggia, 71122, Foggia, Italy
| | - Saurabh Chandan
- Division of Gastroenterology & Hepatology, CHI Health Creighton University Medical Center, Omaha, NE, USA
| | - Banreet Dhindsa
- Gastroenterology & Hepatology, University of Nebraska Medical Center, Omaha, NE, USA
| | - Amaninder Dhaliwal
- Division of Gastroenterology, Moffitt Cancer Center, University of South Florida, Tampa, FL, USA
| | - Stephanie McDonough
- Division of Gastroenterology and Hepatology, Huntsman Cancer Center, University of Utah School of Medicine, 30N 1900E 4R118, Salt Lake City, UT, USA
| | - Douglas G Adler
- Division of Gastroenterology and Hepatology, Huntsman Cancer Center, University of Utah School of Medicine, 30N 1900E 4R118, Salt Lake City, UT, USA.
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Vinod VC, Younis MU, Mubarik H, Rivas H. A rare case of gastric perforation by a 5-year-old Intra-gastric Balloon in situ: Case report and review of literature. Int J Surg Case Rep 2020; 76:480-483. [PMID: 33207414 PMCID: PMC7586043 DOI: 10.1016/j.ijscr.2020.10.028] [Citation(s) in RCA: 1] [Impact Index Per Article: 0.2] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Download PDF] [Figures] [Journal Information] [Subscribe] [Scholar Register] [Received: 09/11/2020] [Revised: 10/06/2020] [Accepted: 10/06/2020] [Indexed: 12/27/2022] Open
Abstract
5-Year-old Intra-gastric Balloon. Gastric perforation. Acute abdomen. Bariatric surgery. Introduction Insertion of an Intra gastric Balloon (IGB) has widely been used as a minimally invasive procedure for the treatment of obesity. Gastric balloons are usually inserted for a period of six months only. They have a high safety profile and one of their rare, reported, serious complications include gastric or esophageal perforation, which are usually early and require immediate operative management. Presentation of case We report a 26-year-old lady who presented to the ED with signs and symptoms of acute abdomen and five-year history of endoscopic placement of Intra-gastric Balloon. Emergent endoscopic removal of the balloon revealed a large pressure ulcer at gastric incisura with central necrosis. Laparoscopy confirmed gastric perforation along lesser curvature with extensive soilage of peritoneal cavity. Extensive irrigation and drainage and Graham omental patch repair were carried out laparoscopically, and the perforation sealed satisfactorily. She recovered well from surgery and within days she was tolerating a diet. Broad spectrum IV antibiotics were given for 10 days. Discussion Gastric perforation is a rare complication reported in 0.1% of patients undergoing IGB insertion. It can ensue as early as days after placement or late at weeks to months. In our review of literature, we found the maximum time frame in which a patient presented with an IGB induced gastric perforation was at 22 months. This makes our case unique as the patient was able to tolerate it for 5 years (60 months) before presenting to the emergency with this sinister complication. Conclusion Very late Gastric perforations in patients with IGB placement are rare. An upper gastrointestinal endoscopy should be arranged as soon as possible to remove the balloon and assess the stomach visualize the perforation followed by a laparoscopic approach to repair the defect if expertise is available.
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Affiliation(s)
- Vijay Chander Vinod
- Mediclinic City Hospital, Dubai Healthcare City, Dubai, United Arab Emirates.
| | | | - Humera Mubarik
- Mediclinic City Hospital, Dubai Healthcare City, Dubai, United Arab Emirates.
| | - Homero Rivas
- Mediclinic City Hospital, Dubai Healthcare City, Dubai, United Arab Emirates.
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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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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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Egan AM, Vella A. Endoscopic Treatments for Obesity: The Good, the Bad, and the Ugly. Endocrinol Metab Clin North Am 2020; 49:315-328. [PMID: 32418593 DOI: 10.1016/j.ecl.2020.02.001] [Citation(s) in RCA: 1] [Impact Index Per Article: 0.2] [Reference Citation Analysis] [Abstract] [Key Words] [MESH Headings] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Indexed: 12/20/2022]
Abstract
In the current setting of an obesity pandemic, there is an urgent need for minimally invasive, safe, and effective interventions for weight loss. Endoscopic bariatric procedures have been developed as an alternative to more traditional medical and surgical therapies. Multiple options are undergoing evaluation or are already available for clinical use. This review aims to describe these treatments, including their mechanisms of action, efficacy, safety and the knowledge gaps regarding their use.
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Affiliation(s)
- Aoife M Egan
- Division of Endocrinology and Diabetes, Department of Medicine, Mayo Clinic, 200 First Street Southwest, Rochester, MN 55905, USA
| | - Adrian Vella
- Division of Endocrinology and Diabetes, Department of Medicine, Mayo Clinic, 200 First Street Southwest, Rochester, MN 55905, USA.
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Changes in Body Adiposity, Dietary Intake, Physical Activity and Quality of Life of Obese Individuals Submitted to Intragastric Balloon Therapy for 6 Months. Obes Surg 2020; 29:843-850. [PMID: 30536199 DOI: 10.1007/s11695-018-3609-x] [Citation(s) in RCA: 5] [Impact Index Per Article: 1.0] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Indexed: 12/25/2022]
Abstract
BACKGROUND Obesity is an important risk factor for several chronic diseases and also is associated with worse quality of life. Intragastric balloon (IGB) is an effective method for weight loss. Although changes in lifestyle are critical to weight loss during and after IGB therapy, only a few studies evaluated dietary intake and none evaluated changes in physical activity with a validated questionnaire during the treatment. The aim of this study was to evaluate changes in total and central body adiposity, dietary intake, physical activity, and quality of life of patients with obesity submitted to IGB treatment for 6 months. METHODS Prospective observational study involving 42 patients with obesity using IGB for 6 months. The patients were evaluated, on the day of insertion and withdrawal or adjustment of IGB for total and central body adiposity (anthropometry and bioelectrical impedance), dietary intake, physical activity (Baecke questionnaire), and quality of life (SF-36 questionnaire). RESULTS There was a significant decrease in total and central body adiposity. The mean % total weight loss and % excess weight loss were 15.88 ± 1.42 and 56.04 ± 4.90, respectively and waist circumference decreased 13.33 ± 1.39 cm. There was a reduction in energy intake, an increase in physical activity, and an improvement of quality of life during IGB treatment. CONCLUSION The present study suggests that IGB treatment during 6 months in individuals with obesity is effective for decreasing total and central body adiposity being associated with reduction in energy intake, increase in physical activity, and improvement in quality of life.
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14
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Changes in resting metabolic rate and body composition due to intragastric balloon therapy. Surg Obes Relat Dis 2019; 16:34-39. [PMID: 31734068 DOI: 10.1016/j.soard.2019.10.011] [Citation(s) in RCA: 7] [Impact Index Per Article: 1.2] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Received: 07/19/2019] [Revised: 09/12/2019] [Accepted: 10/10/2019] [Indexed: 02/07/2023]
Abstract
BACKGROUND Intragastric balloon (IGB) insertion leads to dietary restriction; however, its neurohormonal actions were also described. Resting metabolic rate (RMR) adjusted for body mass (RMR/mass) seems to increase after bariatric interventions, whereas it generally decreases after caloric restriction-based therapies. However, no studies have evaluated the changes in body composition and RMR over IGB treatment. OBJECTIVE To evaluate the relationships between changes in body composition, RMR, RMR/mass, and RMR adjusted for fat-free mass (FFM) (RMR/FFM) over IGB treatment lasting 6 months. SETTING Single-center observational study. METHODS Twenty-one morbidly obese patients treated with IGB (143 ± 20 kg, body mass index [BMI] = 49.5 ± 7.3, 98% ± 29% percent excess weight, 43.6 ± 12.6 yr) were enrolled. Changes in body composition, RMR, RMR/mass, and RMR/FFM were evaluated between 1 month before IGB insertion (time point 1 [TP1]) and 3 months thereafter (TP2). Fourteen patients were also assessed 1 month after IGB removal (TP3). RESULTS There was a 9.5% reduction in weight, a 9.4% reduction in BMI, and 19.1% decrease in percent excess weight at TP2 (n = 21; P < .001); a further 6.5% reduction in weight and BMI and a 13.1% drop in percent excess weight (n = 14, P < .001) at TP3. They were accompanied by a 5.4% reduction in FFM between TP1 and TP2 (n = 21, P < .001). Compared with pretreatment values, at TP2 RMR was 12.5% lower (P < .001) but did not change thereafter. RMR/mass increased 12.4% between TP2 and TP3 (n = 14, P = .02) but on average did not change between TP1 and TP3. The results in the smaller cohort (n = 14) between TP1 and TP2 were consistent with results obtained for the entire cohort. Similar findings were obtained for RMR/FFM. The larger increases in RMR/mass between TP1 and TP3 were associated with more weight loss, larger drop in BMI, and more loss of excess weight (r < -.55, P < .03). CONCLUSION This is the first study to evaluate the relationship between changes in body composition and RMR over IGB treatment. IGB therapy leads to both fat and fat-free mass reductions and RMR decreases. More weight reduction is associated with larger increases in RMR/mass.
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15
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Abstract
Intragastric balloons (IGBs) are the most widely available endoscopic bariatric therapy for class I and II obesity in the United States. Although simple in application and reversible by nature, these devices may help patients initiate the important first steps in weight loss maintenance, provided that parallel efforts are in motion to prevent weight recidivism. Too often, therapeutic nihilism stems from unrealistic expectations of a given therapy. In the case of IGBs, this sentiment may occur when these interventions are applied in a vacuum and not within the purview of a multidisciplinary program that actively involves dieticians, endocrinologists, gastroenterologists, and surgeons. There is a clear and present need to apply different tactics in the remissive strategy to control the obesity pandemic, more so in a struggling landscape of an ever-widening gap in bridging interventions. With such demand, the IGB is an available tool that could be helpful when correctly implemented. In this exposition, we summarize the current state of IGBs available worldwide, discuss their mechanism of action, relay evidence for their short- and long-term efficacy, address safety profile concerns, and suggest procedural considerations in the real-world quotidian application.
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Glass J, Chaudhry A, Zeeshan MS, Ramzan Z. New Era: Endoscopic treatment options in obesity–a paradigm shift. World J Gastroenterol 2019; 25:4567-4579. [PMID: 31528087 PMCID: PMC6718037 DOI: 10.3748/wjg.v25.i32.4567] [Citation(s) in RCA: 20] [Impact Index Per Article: 3.3] [Reference Citation Analysis] [Abstract] [Key Words] [MESH Headings] [Track Full Text] [Download PDF] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Received: 03/28/2019] [Revised: 07/30/2019] [Accepted: 08/07/2019] [Indexed: 02/06/2023] Open
Abstract
The prevalence of obesity continues to rise, and along with it comes a multitude of health-related consequences. The healthcare community has consistently struggled with providing treatment options to obese patients, in part due to the reluctance of patients in pursuing the more effective (yet invasive) surgical approaches such as sleeve gastrectomy and Rou-en-Y gastric bypass. On the other hand, the less invasive approach such as lifestyle/behavioral interventions and pharmacotherapy (Orlistat, Phenteramine, Phentermine/Topiramate, Locaserin, Naltrexon/Buproprion, and Liraglutide) have very limited efficacy, especially in the morbidly obese patients. Despite our best efforts, the epidemic of obesity continues to rise and pose enormous costs on our healthcare system and society. Bariatric endoscopy is an evolving field generated to combat this epidemic through minimally invasive techniques. These procedures can be performed in an ambulatory setting, are potentially reversible, repeatable, and pose less complications than their invasive surgical counterparts. These modalities are designed to alter gut metabolism by means of space occupation, malabsorption, or restriction. In this review we will discuss different bariatric endoscopic options (such as intragastric balloons, endoscopic sleeve gastroplasty, endoscopic aspiration therapies and gastrointestinal bypass sleeves), their advantages and disadvantages, and suggest a new paradigm where providers may start incorporating this modality in their treatment approach for obese patients.
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Affiliation(s)
- Jason Glass
- Department of Digestive and Liver Diseases, University of Texas Southwestern Medical Center, Dallas, TX 75390, United States
| | - Ahson Chaudhry
- Division of Gastroenterology and Hepatology, Department of Medicine, Dallas VA Medical Center, VA North Texas Health Care System, Dallas, TX 75216, United States
- School of Medicine, Temple University Hospital, Philadelphia, PA 19140, United States
| | - Muhammad S Zeeshan
- Division of Gastroenterology and Hepatology, Department of Medicine, Dallas VA Medical Center, VA North Texas Health Care System, Dallas, TX 75216, United States
| | - Zeeshan Ramzan
- Division of Gastroenterology and Hepatology, Department of Medicine, Dallas VA Medical Center, VA North Texas Health Care System, Dallas, TX 75216, United States
- Department of Digestive and Liver Diseases, University of Texas Southwestern Medical Center, Dallas, TX 75390, United States
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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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18
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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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19
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Stavrou G, Tsaousi G, Kotzampassi K. Life-threatening visceral complications after intragastric balloon insertion: Is the device, the patient or the doctor to blame? Endosc Int Open 2019; 7:E122-E129. [PMID: 30705942 PMCID: PMC6342679 DOI: 10.1055/a-0809-4994] [Citation(s) in RCA: 24] [Impact Index Per Article: 4.0] [Reference Citation Analysis] [Abstract] [Track Full Text] [Download PDF] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Received: 07/24/2018] [Accepted: 10/26/2018] [Indexed: 12/16/2022] Open
Abstract
Background and aim Intragastric balloon placement is established as a safe, relatively low-cost and well-tolerated minimally invasive procedure for weight loss, giving encouraging results under the strict prerequisite that the obese patient will enroll in a medically supervised weight loss program. This retrospective study reviews already published cases of severe visceral complications for the purpose of assigning responsibility to the device, the patient, or the doctor. Methods We reviewed PubMed and Scopus archived publications describing intragastric balloon (BIB/Orbera)-related severe visceral complications, i. e. perforations and obstructions. Results Twenty-two cases of gastric perforation, two cases of esophageal perforation and 10 cases of bowel obstruction were found. For the gastric perforation the endoscopist was responsible in nine cases, the patient in four, and the balloon itself in nine. For the two cases of esophageal perforation, the endoscopists were responsible, while for the 12 cases of bowel obstruction, the patient was responsible for seven and the device for the other five cases. Conclusion BIB/Orbera balloon insertion remains a safe procedure, with a minimum of complications related to hollow viscera. Mandatory education and accreditation of physicians dealing with bariatric endoscopy and strict supervision of the obese individuals, while living with the balloon, will eliminate such complications.
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Affiliation(s)
- George Stavrou
- Department of Surgery, Aristotle University of Thessaloniki, Thessaloniki, Greece,Department of General Surgery, York Teaching Hospital, NHS Foundation Trust, York, UK
| | - Georgia Tsaousi
- Department of Surgery, Aristotle University of Thessaloniki, Thessaloniki, Greece
| | - Katerina Kotzampassi
- Department of Surgery, Aristotle University of Thessaloniki, Thessaloniki, Greece,Corresponding author Katerina Kotzampassi, MD, PhD Department of SurgeryAristotle University of ThessalonikiAHEPA Hospital54006 ThessalonikiGreece+30 2313 303496
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20
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Ashrafian H, Monnich M, Braby TS, Smellie J, Bonanomi G, Efthimiou E. Intragastric balloon outcomes in super-obesity: a 16-year city center hospital series. Surg Obes Relat Dis 2018; 14:1691-1699. [PMID: 30193905 DOI: 10.1016/j.soard.2018.07.010] [Citation(s) in RCA: 20] [Impact Index Per Article: 2.9] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Received: 11/17/2017] [Revised: 06/28/2018] [Accepted: 07/09/2018] [Indexed: 02/06/2023]
Abstract
BACKGROUND Intragastric balloons represent an endoscopic therapy aimed at achieving weight loss by mechanical induction of satiety. Their exact role within the bariatric armamentarium remains uncertain. OBJECTIVE Our study aimed to evaluate the use of intragastric balloon therapy alone and before definitive bariatric surgery over a 16-year period. SETTING A large city academic bariatric center for super-obese patients. METHODS Between January 2000 and February 2016, 207 patients underwent ORBERA intragastric balloon placement at esophagogastroduodenoscopy. Four surgeons performed the procedures, and data were entered prospectively into a dedicated bariatric database. Patients' weight loss data were measured through body mass index (BMI) and excess weight loss and recorded at each clinic review for up to 5 years (60 mo). Treatment arms included intragastric balloon alone with lifestyle therapy or intragastric balloon and definitive bariatric surgery: gastric banding, sleeve gastrectomy, or Roux-en-Y gastric bypass. An additional treatment arm of analysis included the overall results from intragastric balloon followed by stapled procedure. RESULTS One hundred twenty-nine female and 78 male patients had a mean age of 44.5 (±11.3) years and a mean BMI of 57.3 (±9.7) kg/m2. Fifty-eight percent of patients suffered from type 2 diabetes. Time from initial or first balloon insertion to definitive surgical therapy ranged between 9 and 13 months. Seventy-six patients had intragastric balloon alone, and 131 had intragastric balloon followed by definitive procedure. At 60 months postoperatively the intragastric balloon alone with lifestyle changes demonstrated an excess weight loss of 9.04% and BMI drop of 3.8; intragastric balloon with gastric banding demonstrated an excess weight loss of 32.9% and BMI drop of 8.9. Intragastric balloon and definitive stapled procedure demonstrated a BMI drop of 17.6 and an excess weight loss of 52.8%. Overall, there were 3 deaths (1.4%), 2 within 10 days due to acute gastric perforation secondary to vomiting and 1 cardiac arrest at 4 weeks postoperatively. CONCLUSION Intragastric balloons can offer effective weight loss in selected super-obese patients within a dedicated bariatric center offering multidisciplinary support. Balloon insertion alone offers only short-term weight loss; however, when combined with definitive bariatric surgical approaches, durable weight loss outcomes can be achieved. A strategy of early and continual vigilance for side effects and a low threshold for removal should be implemented. Surgeon and unit experience with intragastric balloons can contribute to "kick starting" successful weight loss as a bridge to definitive therapy in an established bariatric surgical pathway.
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Affiliation(s)
- Hutan Ashrafian
- Department of Bariatric and Metabolic Surgery, Chelsea and Westminster Hospital, Chelsea, London.
| | - Maren Monnich
- Department of Bariatric and Metabolic Surgery, Chelsea and Westminster Hospital, Chelsea, London
| | - Thomas Stephen Braby
- Department of Bariatric and Metabolic Surgery, Chelsea and Westminster Hospital, Chelsea, London
| | - James Smellie
- Department of Bariatric and Metabolic Surgery, Chelsea and Westminster Hospital, Chelsea, London
| | - Gianluca Bonanomi
- Department of Bariatric and Metabolic Surgery, Chelsea and Westminster Hospital, Chelsea, London
| | - Evangelos Efthimiou
- Department of Bariatric and Metabolic Surgery, Chelsea and Westminster Hospital, Chelsea, London
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21
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Agnihotri A, Xie A, Bartalos C, Kushnir V, Sullivan S, Islam S, Islam E, Lamet M, Lamet A, Farboudmanesch R, Overholt BF, Altawil J, Early DS, Bennett M, Lowe A, Mullady DK, Adeyeri CS, El Zein M, Mishra P, Fayad L, Dunlap M, Oberbach A, Cheskin LJ, Kalloo AN, Khashab MA, Kumbhari V. Real-World Safety and Efficacy of Fluid-Filled Dual Intragastric Balloon for Weight Loss. Clin Gastroenterol Hepatol 2018; 16:1081-1088.e1. [PMID: 29481969 DOI: 10.1016/j.cgh.2018.02.026] [Citation(s) in RCA: 28] [Impact Index Per Article: 4.0] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Received: 11/21/2017] [Revised: 01/23/2018] [Accepted: 02/16/2018] [Indexed: 02/07/2023]
Abstract
BACKGROUND & AIMS Reshape Duo is a saline-filled dual, integrated intragastric balloon (IGB) approved by the Food and Drug Administration for weight loss in patients with obesity. In a prospective, randomized trial, obese patients who received the balloon had significantly greater percent excess weight loss (%EWL) compared with patients treated with diet and exercise alone. However, there are limited data on the real-world efficacy of the Reshape balloon. METHODS We performed a retrospective study of data collected from 2 academic centers and 5 private practices in which all patients paid for the IGB and follow-up visits out of pocket. The IGB was removed after 6 months. We collected data (demographic, medical, and laboratory) from 202 adults (mean age 47.8 ± 10.8 years; 83% female) with a baseline mean body mass index of 36.8 + 8.4 kg/m2 who had IGB insertion for weight loss therapy, along with counselling on lifestyle modifications focused on diet and exercise. Primary outcomes were percent total body weight loss (%TBWL) and %EWL at 1, 3, 6, 9, and 12 months after the procedure. RESULTS Mean %TBWL at 1, 3, 6, 9 and 12 months was 4.8 ± 2.4%, 8.8 ± 4.3%, 11.4 ± 6.7%, 13.3 ± 7.8%, and 14.7 ± 11.8%, respectively. Data were available from 101 patients at 6 months and 12 patients at 12 months; 60.4% of patients achieved more than 10% TBWL and 55.4% had more than 25% EWL. Seventeen patients (8.4%) had esophageal tears during balloon insertion, with no intervention required. Thirteen patients (6.4%) had their IGB removed before the end of the 6-month treatment period. Nausea, vomiting, and abdominal pain were the most common adverse effects, occurring in 149 (73.8%), 99 (49%), and 51 (25.2%) patients. In one patient, the IGB migrated distally leading to small intestinal obstruction requiring surgical removal. CONCLUSION In a retrospective analysis of real-world patients who received the Reshape Duo IGB, we found it to be a safe and efficacious endoscopic method for producing weight loss, with most patients achieving greater than 10% TBWL at 6 months.
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Affiliation(s)
- Abhishek Agnihotri
- Department of Medicine, Johns Hopkins University School of Medicine, Baltimore, Maryland
| | - Amy Xie
- Department of Medicine, Division of Gastroenterology and Hepatology, Johns Hopkins University School of Medicine, Baltimore, Maryland
| | | | - Vladimir Kushnir
- Division of Gastroenterology, Washington University School of Medicine, St Louis, Missouri
| | | | | | - Ebtesam Islam
- Department of Internal Medicine, Texas Tech University Health Sciences Center, Lubbock, Texas
| | - Mark Lamet
- Center for Gastrointestinal Disorders, Hollywood, Florida
| | - Ari Lamet
- Center for Gastrointestinal Disorders, Hollywood, Florida
| | - Ramin Farboudmanesch
- Advanced Gastroenterology and Hepatology of Greater Washington, Vienna, Virginia
| | | | | | - Dayna S Early
- Division of Gastroenterology, Washington University School of Medicine, St Louis, Missouri
| | - Michael Bennett
- Division of Gastroenterology, Washington University School of Medicine, St Louis, Missouri
| | - Abigail Lowe
- Division of Gastroenterology, Washington University School of Medicine, St Louis, Missouri
| | - Daniel K Mullady
- Division of Gastroenterology, Washington University School of Medicine, St Louis, Missouri
| | | | - Mohamad El Zein
- Department of Medicine, Division of Gastroenterology and Hepatology, Johns Hopkins University School of Medicine, Baltimore, Maryland
| | - Priya Mishra
- Department of Medicine, Division of Gastroenterology and Hepatology, Johns Hopkins University School of Medicine, Baltimore, Maryland
| | - Lea Fayad
- Department of Medicine, Division of Gastroenterology and Hepatology, Johns Hopkins University School of Medicine, Baltimore, Maryland
| | - Margo Dunlap
- Department of Medicine, Division of Gastroenterology and Hepatology, Johns Hopkins University School of Medicine, Baltimore, Maryland
| | - Andreas Oberbach
- Department of Medicine, Division of Gastroenterology and Hepatology, Johns Hopkins University School of Medicine, Baltimore, Maryland
| | - Lawrence J Cheskin
- Department of Medicine, Division of Gastroenterology and Hepatology, Johns Hopkins University School of Medicine, Baltimore, Maryland; Department of Health, Behavior and Society, Johns Hopkins Bloomberg School of Public Health, Baltimore, Maryland
| | - Anthony N Kalloo
- Department of Medicine, Division of Gastroenterology and Hepatology, Johns Hopkins University School of Medicine, Baltimore, Maryland
| | - Mouen A Khashab
- Department of Medicine, Division of Gastroenterology and Hepatology, Johns Hopkins University School of Medicine, Baltimore, Maryland
| | - Vivek Kumbhari
- Department of Medicine, Division of Gastroenterology and Hepatology, Johns Hopkins University School of Medicine, Baltimore, Maryland.
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Twardzik M, Wiewiora M, Glück M, Piecuch J. Mechanical intestinal obstruction caused by displacement of a stomach balloon - case report. Wideochir Inne Tech Maloinwazyjne 2018; 13:278-281. [PMID: 30002764 PMCID: PMC6041590 DOI: 10.5114/wiitm.2018.73446] [Citation(s) in RCA: 2] [Impact Index Per Article: 0.3] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Download PDF] [Figures] [Journal Information] [Subscribe] [Scholar Register] [Received: 09/18/2017] [Accepted: 11/17/2017] [Indexed: 01/27/2023] Open
Abstract
Methods of treating obesity in selected cases include endoscopically performed procedures, among them endoscopically placed intragastric balloons. It is a method associated with a low complication rate, traditionally reserved to treat the most obese patients. Balloon rupture or deflation and its migration into the small bowel is one of the possible complications. In some cases, the balloon moves through the digestive tract without side effects. When the balloon's displacement in the intestine is impossible, gastrointestinal obstruction occurs. We report a case of a patient with a mechanical obstruction of the gastrointestinal tract caused by asymptomatic balloon rupture and its migration into the jejunum.
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Affiliation(s)
- Maciej Twardzik
- Department of General and Bariatric Surgery and Emergency Medicine, School of Medicine with the Division of Dentistry in Zabrze, Medical University of Silesia in Katowice, Poland
| | - Maciej Wiewiora
- Department of General and Bariatric Surgery and Emergency Medicine, School of Medicine with the Division of Dentistry in Zabrze, Medical University of Silesia in Katowice, Poland
| | - Marek Glück
- Department of General and Bariatric Surgery and Emergency Medicine, School of Medicine with the Division of Dentistry in Zabrze, Medical University of Silesia in Katowice, Poland
| | - Jerzy Piecuch
- Department of General and Bariatric Surgery and Emergency Medicine, School of Medicine with the Division of Dentistry in Zabrze, Medical University of Silesia in Katowice, Poland
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23
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Kool N, Müggler SA. Gastric outlet obstruction: a rare complication in patients with intragastric balloon treatment for obesity. BMJ Case Rep 2018; 2018:bcr-2018-224394. [PMID: 29735502 DOI: 10.1136/bcr-2018-224394] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Key Words] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Indexed: 11/04/2022] Open
Affiliation(s)
- Nicoline Kool
- Department of Internal Medicine, Zollikerberg Hospital, Zollikerberg, Switzerland
| | - Simon Andreas Müggler
- Department of Internal Medicine, Zollikerberg Hospital, Zollikerberg, Switzerland.,Faculty of Medicine, University of Zurich, Zurich, Switzerland
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24
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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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An Autopsy Case of Misdiagnosed Wernicke's Syndrome after Intragastric Balloon Therapy. Case Rep Gastrointest Med 2018; 2018:1510850. [PMID: 29666718 PMCID: PMC5831924 DOI: 10.1155/2018/1510850] [Citation(s) in RCA: 1] [Impact Index Per Article: 0.1] [Reference Citation Analysis] [Abstract] [Track Full Text] [Download PDF] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Received: 09/21/2017] [Revised: 01/06/2018] [Accepted: 01/21/2018] [Indexed: 01/21/2023] Open
Abstract
Intragastric balloon (IGB) therapy is a widely used technique to counter obesity, and it is known to be safe and effective. Although there can be a high rate of side effects following IGB therapy, most are self-healing and they are mainly accommodative in nature. Few cases of Wernicke's syndrome under IGB therapy have been described in the literature, and to the best of our knowledge, none have been fatal. We present here a case of a 51-year-old woman who underwent IGB therapy over 8 months. Late diagnosed Wernicke's syndrome that first appeared as lower limb neuropathy progressively immobilized the patient, until she required bed rest. Finally, a major complication of pneumonia caused her death. Wernicke's syndrome has been mainly related to bariatric surgery techniques, but it must also be linked to IGB therapy (and also to other restrictive weight-loss interventions). As the use of IGB therapy spreads, the literature must alert physicians to this complication. Wernicke's syndrome is a severe but reversible condition when diagnosed and treated early.
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Al-Subaie S, Al-Barjas H, Al-Sabah S, Al-Helal S, Alfakharani A, Termos S. Laparoscopic management of a small bowel obstruction secondary to Elipse intragastric balloon migration: A case report. Int J Surg Case Rep 2017; 41:287-291. [PMID: 29127916 PMCID: PMC5683749 DOI: 10.1016/j.ijscr.2017.10.050] [Citation(s) in RCA: 10] [Impact Index Per Article: 1.3] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Download PDF] [Figures] [Journal Information] [Subscribe] [Scholar Register] [Received: 10/02/2017] [Accepted: 10/30/2017] [Indexed: 12/12/2022] Open
Abstract
INTRODUCTION The Elipse™ intragastric balloon (IGB) for weight loss is a swallowable capsule that is filled with 550mL of fluid and resides in the stomach for four months before being excreted from the gastrointestinal tract. Although initial data showed that use of this device is safe and free from serious complications, we report for the first time the successful management of an Elipse™ IGB-related adverse event. PRESENTATION OF CASE A 41-year-old woman presented to our emergency department following two days of abdominal pain, vomiting, and constipation. Her medical history included four caesarean sections and insertion of the Elipse™ IGB 16 weeks prior to presentation. The patient was vitally stable at presentation and abdominal examination revealed a mildly distended abdomen. Plain X-ray revealed a small bowel obstruction (SBO), and a double contrast computed tomography scan showed a dilated small bowel with mild free fluid proximal to a transition zone at the distal jejunum. Laparoscopic enterotomy was performed just proximal to the obstruction site, and the balloon was visualized and extracted after it had been incised and emptied. The enterotomy incision was closed with an intracorporeal continuous absorbable suture. The patient's recovery was uneventful and she was discharged on postoperative day 4. DISCUSSION We discuss the possible etiologies of SBO following Elipse™ IGB insertion, and present a brief literature review regarding surgical and nonsurgical management options for such cases. CONCLUSION Although initial data showed the Elipse™ IGB to be safe, complications can occur and be managed successfully.
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Affiliation(s)
- Saud Al-Subaie
- Department of Surgery, Amiri Hospital, Ministry of Health, Kuwait; Kuwait Association of Surgeons, Kuwait.
| | - Hamad Al-Barjas
- Department of Surgery, Amiri Hospital, Ministry of Health, Kuwait
| | - Salman Al-Sabah
- Department of Surgery, Amiri Hospital, Ministry of Health, Kuwait; Kuwait Association of Surgeons, Kuwait
| | - Saud Al-Helal
- Department of Surgery, Amiri Hospital, Ministry of Health, Kuwait
| | | | - Salah Termos
- Department of Surgery, Amiri Hospital, Ministry of Health, Kuwait
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Al-Subaie S, Khalifa S, Buhaimed W, Al-Rashidi S. A prospective pilot study of the efficacy and safety of Elipse intragastric balloon: A single-center, single-surgeon experience. Int J Surg 2017; 48:16-22. [PMID: 28989057 DOI: 10.1016/j.ijsu.2017.10.001] [Citation(s) in RCA: 11] [Impact Index Per Article: 1.4] [Reference Citation Analysis] [Abstract] [Key Words] [MESH Headings] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Received: 06/11/2017] [Revised: 09/19/2017] [Accepted: 10/01/2017] [Indexed: 12/16/2022]
Abstract
BACKGROUND Elipse™ is the least invasive IGB for weight loss that needs no sedation or endoscopy. It is a swallowable capsule filled with 550 mL of fluid, which stays in the stomach for 16 weeks and is excreted from the gastrointestinal tract. Kuwait is one of the first countries to start using Elipse™ as a weight loss device. This study aims to evaluate the efficacy and safety of Elipse™ intragastric balloon (IGB). MATERIALS AND METHODS This is a single-center prospective pilot study of 51 Elipse™ insertions at our clinic. The patients were followed for 4 months to monitor their weight and body mass index (BMI) at 1, 2, and 4 months. Total weight loss, % excess weight loss (%EWL), % total body weight loss (%TBWL), and change in BMI and waist circumference (WC) were recorded at the end of the study. A short survey was administered to evaluate symptoms, complications, and overall satisfaction. RESULTS Fifty-one patients participated, of which five had Elipse™ removed because of intolerance. One case vomited the balloon; one had early deflation. The total weight loss was 8.84 kg, %TBWL 10.44%, %EWL 40.84%, change in BMI 3.42 kg/m2, and the total WC reduction 8.62 cm. Symptoms after insertion were severe, whereas those during excretion were mild and self-limiting. No serious complications were recorded, and the overall satisfaction was above average. CONCLUSION Our data proves that Elipse™ is a safe and effective device for weight loss. Nevertheless, some limitations were observed that need to be overcome for better outcomes. Larger studies are needed to support our findings.
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Affiliation(s)
- Saud Al-Subaie
- Surgery Clinic, Faisal Polyclinic, Kuwait; Kuwait Association of Surgeons, Kuwait.
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