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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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Abdulla M, Mohammed N, AlQamish J. Overview on the endoscopic treatment for obesity: A review. World J Gastroenterol 2023; 29:5526-5542. [PMID: 37970474 PMCID: PMC10642436 DOI: 10.3748/wjg.v29.i40.5526] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [Key Words] [MESH Headings] [Track Full Text] [Download PDF] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Received: 08/03/2023] [Revised: 09/15/2023] [Accepted: 10/23/2023] [Indexed: 10/27/2023] Open
Abstract
Obesity rates have increased, and so has the need for more specific treatments. This trend has raised interest in non-surgical weight loss techniques that are novel, safe, and straightforward. Thus, the present review describes the endoscopic bariatric treatment for obesity, its most recent supporting data, the questions it raises, and its future directions. Various endoscopic bariatric therapies for weight reduction, such as intragastric balloons (IGBs), aspiration therapy (AT), small bowel endoscopy, endoscopic sleeve gastroplasty, endoluminal procedures, malabsorption endoscopic procedures, and methods of regulating gastric emptying, were explored through literature sourced from different databases. IGBs, AT, and small bowel endoscopy have short-term effects with a possibility of weight regain. Minor adverse events have occurred; however, all procedures reduce weight. Vomiting and nausea are common side effects, although serious complications have also been observed.
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Affiliation(s)
- Maheeba Abdulla
- Department of Internal Medicine, Ibn Al Nafees Hospital, Manama 54533, Bahrain
| | - Nafeesa Mohammed
- Department of Intensive Care Unit, Salmaniya Medical Complex, Manama 5616, Bahrain
| | - Jehad AlQamish
- Department of Internal Medicine, Ibn Al Nafees Hospital, Manama 54533, Bahrain
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Avci E, Ay S. Results of intragastric balloon treatment and evaluation of patient satisfaction. J Minim Access Surg 2023; 19:493-497. [PMID: 37357492 PMCID: PMC10695307 DOI: 10.4103/jmas.jmas_353_22] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Received: 12/14/2022] [Revised: 01/12/2023] [Accepted: 02/02/2023] [Indexed: 06/27/2023] Open
Abstract
Introduction Endoscopic bariatric therapies are an alternative treatment method for patients who do not respond to diet, exercise and drug therapy or who are not yet candidates for surgery or who are suitable and hesitant to undergo surgery. In this study, we aimed to evaluate our intragastric balloon (IGB) treatment results and the satisfaction of the patients in the light of the literature. Materials and Methods The study was conducted by retrospectively evaluating the patients who underwent IGB application in the gastroenterology and general surgery endoscopy units of our hospital. Results Sixty-eight patients who had IGB for 6 months were evaluated. The mean weight given was 10 (0-25) kg and the mean body mass index (BMI) decrease was 3.6 (0-9) kg/m2. A statistically significant decrease was obtained between the initial weight and BMI of our patients and the weight and BMI at the end of the 6th month (P ≤ 0.0001). Thirty-five (51.5%) patients reported that they were satisfied with the procedure, while 33 (48.5) reported that they were not satisfied. conclusion IGBs for the treatment of obesity are an attractive form of treatment because they provide minimally invasive, temporary and significant weight loss. Patients need to be repeatedly told that diet and lifestyle changes should be followed in the treatment of IGB. Thus, we believe that possible disappointments can be prevented.
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Affiliation(s)
- Enver Avci
- Department of Gastroenterology, KTO Karatay University Medical School Medicana Affiliated Hospital, Konya, Türkiye
| | - Serden Ay
- Department of General Surgery, KTO Karatay University Medical School Medicana Affiliated Hospital, Konya, Türkiye
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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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Mathus-Vliegen E, Spångeus A, Walter S, Ericson AC. Weight loss with or without intragastric balloon causes divergent effects on ghrelin cell expression. Obes Sci Pract 2021; 7:199-207. [PMID: 33841889 PMCID: PMC8019283 DOI: 10.1002/osp4.478] [Citation(s) in RCA: 7] [Impact Index Per Article: 1.8] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Download PDF] [Figures] [Journal Information] [Subscribe] [Scholar Register] [Received: 08/20/2020] [Revised: 12/03/2020] [Accepted: 12/09/2020] [Indexed: 12/11/2022] Open
Abstract
Objective The mechanism of action of intragastric balloons in the treatment of obesity is not fully understood. One of the hypotheses is that balloons might have an effect on the fundus, the area of ghrelin production. Methods Participants were randomized to a 13‐week period of sham or balloon treatment followed by a 13‐week period of balloon therapy in everyone. Blood samples for ghrelin levels were taken in the fasting state and after a breakfast at the start, after 13 and 26 weeks. Biopsies for ghrelin cell immunohistochemistry were taken from the fundus at endoscopy. Results Seven participants entered the balloon–balloon (BB) group and 11 the sham–balloon (SB) group. Despite a considerable weight loss, a median −17.9 kg (interquartile ranges −23.8 to −0.5) in the BB group and −18.3 kg (−22.7 to −14.7) in the SB group, fasting ghrelin and meal‐induced ghrelin response did not change. In the SB group, the number of ghrelin cells increased significantly (p 0.001) from 110.6 (83.6–118.9) to 160.2 (128.5–223.0) while on sham treatment and returned to initial levels, 116.3 (91.7–146.9) (p 0.001), when they received their first balloon. No significant changes in ghrelin cell numbers were observed in the BB group. Conclusion In participants without a balloon, weight loss induced an increase in ghrelin cell numbers in the fundus, which was annulled by the subsequent placement of a balloon. The effect of a balloon might be explained by effects on ghrelin cell numbers or ghrelin cell activity.
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Affiliation(s)
- Elisabeth Mathus-Vliegen
- Department of Gastroenterology and Hepatology Academic Medical Centre (AMC) University of Amsterdam Amsterdam the Netherlands
| | - Anna Spångeus
- Department of Health, Medicine and Caring Sciences Division of Diagnostics and Specialist Medicine Linköping University Linköping Sweden.,Department of Acute Internal Medicine and Geriatrics Linköping University Hospital Linköping University Linköping Sweden
| | - Susanna Walter
- Department of Biomedical and Clinical Sciences Division of Inflammation and Infection Medical Faculty Linköping University Linköping Sweden.,Department of Gastroenterology Linköping University Hospital Linköping University Linköping Sweden
| | - Ann-Charlott Ericson
- Department of Biomedical and Clinical Sciences Division of Molecular Medicine and Virology Medical Faculty Linköping University Linköping Sweden
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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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Haddad AE, Rammal MO, Soweid A, Shararra AI, Daniel F, Rahal MA, Shaib Y. Intragastric balloon treatment of obesity: Long-term results and patient satisfaction. TURKISH JOURNAL OF GASTROENTEROLOGY 2020; 30:461-466. [PMID: 31061001 DOI: 10.5152/tjg.2019.17877] [Citation(s) in RCA: 17] [Impact Index Per Article: 3.4] [Reference Citation Analysis] [Abstract] [Track Full Text] [Subscribe] [Scholar Register] [Indexed: 12/16/2022]
Abstract
BACKGROUND/AIMS Intragastric balloon (IGB) treatment of obesity is a minimally invasive outpatient procedure that has been shown to help weight loss in some patients. The aim of this study is to analyze the long-term results regarding the effectiveness, tolerability, and patient satisfaction in a cohort of patients undergoing the IGB insertion. MATERIALS AND METHODS Using a retrospective cohort study design, patients who had their IGB inserted/removed between the years 2009 and 2016 were contacted by phone and asked to answer a short questionnaire. The baseline characteristics, pre- and post- IGB weight, as well as their current weight were recorded. Different parameters of satisfaction were noted in addition to whether patients resorted to alternative weight-reduction measures. RESULTS Ninety-nine eligible patients were contacted, and 65 consented to the study. The average weight loss achieved at the end of the treatment period (3 to 10 months) was approximately a 12% decrease from the baseline. Only 39% of patients were satisfied with the procedure, and less than 50% were satisfied with the weight loss achieved. When assessing the long-term follow-up, years after the IGB removal (3.3±1.76 years), the vast majority of patients (78.7%) regained weight or resorted to further bariatric measures. CONCLUSION IGB leads to weight loss among most patients, but it does not appear to fulfill patients' expectations. Further, the initial weight loss is not sustainable over time.
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Affiliation(s)
- Aline El Haddad
- Division of Gastroenterology, Department of Internal Medicine, American University of Beirut Medical Center, Beirut, Lebanon
| | - Mohammad O Rammal
- Division of Gastroenterology, Department of Internal Medicine, American University of Beirut Medical Center, Beirut, Lebanon
| | - Assaad Soweid
- Division of Gastroenterology, Department of Internal Medicine, American University of Beirut Medical Center, Beirut, Lebanon
| | - Ala I Shararra
- Division of Gastroenterology, Department of Internal Medicine, American University of Beirut Medical Center, Beirut, Lebanon
| | - Fady Daniel
- Division of Gastroenterology, Department of Internal Medicine, American University of Beirut Medical Center, Beirut, Lebanon
| | - Mahmoud A Rahal
- Division of Gastroenterology, Department of Internal Medicine, American University of Beirut Medical Center, Beirut, Lebanon
| | - Yasser Shaib
- Division of Gastroenterology, Department of Internal Medicine, American University of Beirut Medical Center, Beirut, Lebanon
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Yorke E, Switzer NJ, Reso A, Shi X, de Gara C, Birch D, Gill R, Karmali S. Intragastric Balloon for Management of Severe Obesity: a Systematic Review. Obes Surg 2017; 26:2248-2254. [PMID: 27444806 DOI: 10.1007/s11695-016-2307-9] [Citation(s) in RCA: 67] [Impact Index Per Article: 8.4] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Indexed: 12/15/2022]
Abstract
Older models of intragastric balloons (IGBs) had unacceptably high complication rates and inconsequential weight loss. With FDA approval of newer models, we aimed to systematically examine the literature regarding the efficacy of IGB therapy for obesity. A comprehensive electronic database search was completed. Title searching was restricted to the following keywords: bariatric, gastric, gastric bypass, gastric band, sleeve gastrectomy, and intragastric balloon. Twenty-six primary studies (n = 6101) were included. At balloon removal, mean change in weight and BMI were 15.7 ± 5.3 kg and 5.9 ± 1.0 kg/m(2). The most common complications were nausea/vomiting (23.3 %) and abdominal pain (19.9 %). Serious complications were rare: mortality (0.05 %) and gastric perforation (0.1 %). IGBs are associated with marked short-term weight loss with limited serious complications.
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Affiliation(s)
- Ekua Yorke
- Department of Surgery, University of Alberta, Edmonton, Alberta, Canada
| | - Noah Jacob Switzer
- Department of Surgery, University of Alberta, Edmonton, Alberta, Canada. .,2D, Walter C Mackenzie Health Sciences Centre, University of Alberta, 840-112 Street, Edmonton, Alberta, T6G 2B7, Canada.
| | - Artan Reso
- Department of Surgery, University of Calgary, Calgary, Alberta, Canada
| | - Xinhe Shi
- Center for the Advancement of Minimally Invasive Surgery (CAMIS), Royal Alexandria Hospital, Edmonton, Alberta, Canada
| | - Christopher de Gara
- Department of Surgery, University of Alberta, Edmonton, Alberta, Canada.,Center for the Advancement of Minimally Invasive Surgery (CAMIS), Royal Alexandria Hospital, Edmonton, Alberta, Canada
| | - Daniel Birch
- Department of Surgery, University of Alberta, Edmonton, Alberta, Canada.,Center for the Advancement of Minimally Invasive Surgery (CAMIS), Royal Alexandria Hospital, Edmonton, Alberta, Canada
| | - Richdeep Gill
- Department of Surgery, University of Calgary, Calgary, Alberta, Canada
| | - Shahzeer Karmali
- Department of Surgery, University of Alberta, Edmonton, Alberta, Canada.,Department of Surgery, University of Calgary, Calgary, Alberta, Canada
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Short-term outcomes of the new intragastric balloon End-Ball ® for treatment of obesity. Wideochir Inne Tech Maloinwazyjne 2016; 11:229-235. [PMID: 28194241 PMCID: PMC5299079 DOI: 10.5114/wiitm.2016.63988] [Citation(s) in RCA: 5] [Impact Index Per Article: 0.6] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Download PDF] [Journal Information] [Subscribe] [Scholar Register] [Received: 09/05/2016] [Accepted: 10/19/2016] [Indexed: 12/23/2022] Open
Abstract
INTRODUCTION Intragastric balloons (IGBs) have been successfully used to treat obesity for the last 18 years. These balloons are made of different materials and filled with either air or saline. It seems that balloons filled with saline result in more effective weight loss, but are associated with worse tolerance after implantation. In contrast, balloons filled with air are associated with excellent tolerance, but result in less effective weight loss. AIM To report the early safety and effectiveness results of the End-Ball® balloon and to encourage discussions on how to best use this new-generation IGB for endoscopic weight loss management. MATERIAL AND METHODS Twenty obese patients (mean age: 40.5 years; mean body mass index: 34.8 kg/m2) were included in a 6-month study. Balloons were inflated with 300 ml of saline containing 5 ml of methylene blue and 300 cm3 of air. RESULTS No serious adverse events occurred during treatment. Patients experienced varying degrees of nausea, vomiting (mean: 3.7 times the first day), and abdominal pain after implantation. Six months (23-29 weeks) after End-Ball® balloon insertion, we observed a significant decrease in body weight (13.9 ±5.1 kg) and percent excess weight loss (37.9 ±12.9%). We also found a significant decrease in the levels of glycated hemoglobin (p < 0.001), C-peptide (p < 0.002), and triacylglycerols (p < 0.001) and an increase in the concentration of high-density lipoprotein cholesterol (p < 0.025). CONCLUSIONS The End-Ball® IGB is a safe and effective treatment for morbid obesity, with positive effects on weight loss and saccharide metabolism.
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Abstract
The obesity epidemic, recognized by the World Health Organization in 1997, refers to the rising incidence of obesity worldwide. Lifestyle modification and pharmacotherapy are often ineffective long-term solutions; bariatric surgery remains the gold standard for long-term obesity weight loss. Despite the reported benefits, it has been estimated that only 1% of obese patients will undergo surgery. Endoscopic treatment for obesity represents a potential cost-effective, accessible, minimally invasive procedure that can function as a bridge or alternative intervention to bariatric surgery. We review the current endoscopic bariatric devices including space occupying devices, endoscopic gastroplasty, aspiration technology, post-bariatric surgery endoscopic revision, and obesity-related NOTES procedures. Given the diverse devices already FDA approved and in development, we discuss the future directions of endoscopic therapies for obesity.
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Affiliation(s)
- Kartik Sampath
- Section of Gastroenterology and Hepatology, Department of Medicine, Dartmouth-Hitchcock Medical Center, Geisel School of Medicine at Dartmouth, Lebanon, NH, USA.
- Gastroenterology Fellow, Section of Gastroenterology and Hepatology, Dartmouth-Hitchcock Medical Center, One Medical Center Drive, Lebanon, NH, 03756, USA.
| | - Amreen M Dinani
- Section of Gastroenterology and Hepatology, Department of Medicine, Dartmouth-Hitchcock Medical Center, Geisel School of Medicine at Dartmouth, Lebanon, NH, USA
| | - Richard I Rothstein
- Section of Gastroenterology and Hepatology, Department of Medicine, Dartmouth-Hitchcock Medical Center, Geisel School of Medicine at Dartmouth, Lebanon, NH, USA
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Camilleri M, Acosta A. Gastrointestinal traits: individualizing therapy for obesity with drugs and devices. Gastrointest Endosc 2016; 83:48-56. [PMID: 26271184 PMCID: PMC4548831 DOI: 10.1016/j.gie.2015.08.007] [Citation(s) in RCA: 21] [Impact Index Per Article: 2.3] [Reference Citation Analysis] [Abstract] [Key Words] [MESH Headings] [Grants] [Track Full Text] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Received: 06/04/2015] [Accepted: 08/01/2015] [Indexed: 02/06/2023]
Abstract
BACKGROUND AND AIMS The aims of this article were to review the discrepancy between numbers of people requiring weight loss treatment and results and to assess the potential effects of pharmacologic treatments (recently approved for obesity) and endoscopically deployed devices on quantitative GI traits in development for obesity treatment. METHODS We conducted a review of relevant literature to achieve our objectives. RESULTS The 2013 guidelines increased the number of adults recommended for weight loss treatment by 20.9% (116.0 million to 140.2 million). There is an imbalance between efficacy and costs of commercial weight loss programs and drug therapy (average weight loss about 5 kg). The number of bariatric procedures performed in the United States has doubled in the past decade. The efficacy of bariatric surgery is attributed to reduction in the volume of the stomach, nutrient malabsorption with some types of surgery, increased postprandial incretin responses, and activation of farnesoid X receptor mechanisms. These GI and behavioral traits identify sub-phenotypes of obesity, based on recent research. CONCLUSIONS The mechanisms or traits targeted by drug and device treatments include centrally mediated alterations of appetite or satiation, diversion of nutrients, and alteration of stomach capacity, gastric emptying, or incretin hormones. Future treatment may be individualized based on quantitative GI and behavioral traits measured in obese patients.
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Affiliation(s)
- Michael Camilleri
- Clinical Enteric Neuroscience Translational and Epidemiological Research (C.E.N.T.E.R.), Mayo Clinic College of Medicine, Rochester, Minnesota, USA
| | - Andres Acosta
- Clinical Enteric Neuroscience Translational and Epidemiological Research (C.E.N.T.E.R.), Mayo Clinic College of Medicine, Rochester, Minnesota, USA
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12
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Gleysteen JJ. A history of intragastric balloons. Surg Obes Relat Dis 2015; 12:430-5. [PMID: 26775045 DOI: 10.1016/j.soard.2015.10.074] [Citation(s) in RCA: 62] [Impact Index Per Article: 6.2] [Reference Citation Analysis] [Abstract] [Key Words] [MESH Headings] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Received: 08/18/2015] [Revised: 10/08/2015] [Accepted: 10/13/2015] [Indexed: 02/06/2023]
Abstract
The history of intragastric balloons (IGBs) began in 1985 with the Garren-Edwards Bubble. It was approved by the U.S. Food and Drug Administration (FDA) for temporary use as a weight loss device, but its manufacture was discontinued in 1988, and approval was withdrawn in 1992 because of significant complications and limited and recidivistic weight loss. A number of IGBs have appeared since that time, mostly originating in Europe or South America, but none has acquired FDA approval until recently; the ReShape Duo Integrated Dual Balloon System (ReShape Medical Inc., San Clemente, California) received FDA approval in August 2015. The conclusions of an important 1987 international conference on IGBs and the characteristics, effectiveness, and problems of most other IGBs are described in this text. The common purpose of these devices as preliminary interventions before gastric bariatric surgery and their favorable effects on this purpose are emphasized and may have played a key role in the FDA's change of outlook of the IGB.
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Affiliation(s)
- John J Gleysteen
- Department of Surgery, University of Alabama at Birmingham, Birmingham, Alabama.
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Effects of the intragastric balloon MedSil on weight loss, fat tissue, lipid metabolism, and hormones involved in energy balance. Obes Surg 2015; 24:909-15. [PMID: 24488758 PMCID: PMC4022986 DOI: 10.1007/s11695-014-1191-4] [Citation(s) in RCA: 29] [Impact Index Per Article: 2.9] [Reference Citation Analysis] [Abstract] [Track Full Text] [Download PDF] [Figures] [Journal Information] [Subscribe] [Scholar Register] [Indexed: 02/06/2023]
Abstract
Background The prevalence of obesity continues to increase worldwide. Because obesity is associated with a number health-related problems as well as a shortened life span, treating obesity is an important clinical concern. Although various treatments are currently available, many are not efficacious in the long term. Therefore, additional medical treatment options for morbidly obese individuals must be explored. In this study, we examined the effects of the intragastric balloon MedSil® on anthropometric measures and hormones associated with lipid and energy metabolism. Methods Twenty-two obese patients underwent insertion of the intragastric balloon MedSil® following a clinical exam, body composition scan, and collection of blood samples. Six months following implantation of the balloon, additional anthropometric and serological measures were taken. Results Six months following insertion of the MedSil® balloon, we observed significant decreases in body weight, body mass index, and fat mass. Compared with baseline levels, ghrelin serum levels were increased significantly, while leptin, FGF21, and glycated hemoglobin levels significantly decreased, 6 months after balloon insertion. Conclusions The MedSil® intragastric balloon is a safe and effective treatment for morbid obesity, with positive effects on anthropometric measures and lipid metabolism.
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Mathus-Vliegen EMH. Endoscopic treatment: the past, the present and the future. Best Pract Res Clin Gastroenterol 2014; 28:685-702. [PMID: 25194184 DOI: 10.1016/j.bpg.2014.07.009] [Citation(s) in RCA: 35] [Impact Index Per Article: 3.2] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Received: 05/21/2014] [Revised: 06/21/2014] [Accepted: 07/05/2014] [Indexed: 02/07/2023]
Abstract
The obesity epidemic asks for an active involvement of gastroenterologists: many of the co-morbidities associated with obesity involve the gastrointestinal tract; a small proportion of obese patients will need bariatric surgery and may suffer from surgical complications that may be solved by minimally invasive endoscopic techniques; and finally, the majority will not be eligible for bariatric surgery and will need some other form of treatment. The first approach should consist of an energy-restricted diet, physical exercise and behaviour modification, followed by pharmacotherapy. For patients who do not respond to medical therapy but are not or not yet surgical candidates, an endoscopic treatment might look attractive. So, endoscopic bariatric therapy has a role to play either as an alternative or adjunct to medical treatment. The different endoscopic modalities may vary in mechanisms of action: by gastric distension and space occupation, delayed gastric emptying, gastric restriction and decreased distensibility, impaired gastric accommodation, stimulation of antroduodenal receptors, or by duodenal exclusion and malabsorption. These treatments will be discussed into detail.
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Affiliation(s)
- E M H Mathus-Vliegen
- Academic Medical Centre, University of Amsterdam, Meibergdreef 9, 1105 AZ Amsterdam, The Netherlands.
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15
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Mohammed MA, Anwar R, Mansour AH, Elmasry E, Othman G. Effects of Intragastric Balloon Versus Conservative Therapy on Appetite Regulatory Hormones in Obese Subjects. ACTA ACUST UNITED AC 2014. [DOI: 10.3923/tmr.2014.58.80] [Citation(s) in RCA: 16] [Impact Index Per Article: 1.5] [Reference Citation Analysis] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Indexed: 11/15/2022]
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16
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Caglar E, Dobrucali A, Bal K. Gastric balloon to treat obesity: filled with air or fluid? Dig Endosc 2013; 25:502-507. [PMID: 23369002 DOI: 10.1111/den.12021] [Citation(s) in RCA: 20] [Impact Index Per Article: 1.7] [Reference Citation Analysis] [Abstract] [Key Words] [MESH Headings] [Track Full Text] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Received: 08/12/2012] [Accepted: 11/09/2012] [Indexed: 12/24/2022]
Abstract
BACKGROUND Our aim was to study the efficacy and safety of different types of intragastric balloon in morbidly obese patients. PATIENTS AND METHODS From 2005 to 2011, intragastric balloons were inserted endoscopically into 32 patients. Intragastric balloons were used in morbidly obese (body mass index [BMI] ≥ 35 kg/m(2) ) individuals who were non-responsive to 6-month medical therapy and diet. Balloons were endoscopically removed after 6 months. RESULTS Thirty-six balloons were inserted in a total of 32 patients. Mean age of the patients was 37.28 ± 12.08 (17-64) years and mean height was 169.81 ± 8.17 (150-185) cm. Initial mean weight was 128.87 ± 23.31 kg and BMI was 45.26 ± 8.48 kg/m(2) . At month 6, mean bodyweight was 116.93 ± 23.18 and BMI was 40.96 ± 7.96 kg/m(2) (P < 0.001, P < 0.001, respectively). At the end of 6 months, while the excessweight loss (EWL) median was 13.0 kg, [interquartile range IQR: 5.0-16.0] and percent EWL median was 21.92, [IQR: 12.72-28.49] in the Heliosphere BAG patients, the EWL median was 19.0 kg, [IQR: 14.47-26.72] and the percent EWL median was 38.26, [IQR: 19.73-47.79] in the BioEnterics Intragastric Balloon patients (P = 0.006, P = 0.010, respectively for EWL median and percent EWL median). One patient died (3.1%) of cardiac arrest due to aspiration at day 13 after BIB placement. CONCLUSION Although not without risk, intragastric balloon placement is an effective method for weight loss. BioEnterics Intragastric Balloon is more effective in helping weight loss than the Heliosphere BAG balloon.
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Affiliation(s)
- Erkan Caglar
- Gastroenterology Department, Cerrahpasa Medical Faculty, Istanbul University, Istanbul, Turkey.
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Abstract
BACKGROUND The positioning of an intragastric saline-filled balloon has been developed as temporary and reversible therapeutic option for treatment of morbid obesity. Recently, an air-filled balloon was also developed. The aim of this study is to prospectively compare these two devices in terms of weight loss parameters, safety, and tolerance. METHODS Sixty patients were randomized into two groups: group A (Bioenterics Intragastric Balloon-BIB; n = 30; 20 F/10 M, mean age 36.7 ± 10.9; mean BMI 46.5 ± 5.9) and group B (Endobag-Heliosphere; n = 30; 20 F/10 M, mean age 37.8 ± 10.6; mean BMI 46.1 ± 5.6). All patients of both groups were sedated with midazolam (5 mg) + Propofol (2 mg/kg i.v.). The Heliosphere Bag was air-filled with 950 ml while BIB® was inflated with 500 ml of saline and 10 ml of methylene blue. Percentage of excess weight loss (%EWL) and body mass index (BMI) were evaluated. Student t test, Fisher exact test, and χ(2) test were used for statistical analysis. RESULTS Similar weight loss parameters were observed in patients treated with liquid or air-filled balloon at time of removal: mean BMI was 40.8 ± 6.2 and 41.9 ± 6.5(p = ns), and mean %EWL was 20 ± 12 and 18 ± 14 (p = ns) in groups A and B, respectively. Significant longer extraction time, with high patient discomfort, was observed in group B due to difficult passage through the cardia and the lower pharynx. CONCLUSIONS Air-filled balloon can be another valid therapeutic option in the temporary treatment of obesity, but at this time, the quality of the device must be improved to ameliorate the patient compliance at removal and avoid the spontaneous deflations.
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Mion F, Ibrahim M, Marjoux S, Ponchon T, Dugardeyn S, Roman S, Deviere J. Swallowable Obalon® gastric balloons as an aid for weight loss: a pilot feasibility study. Obes Surg 2013; 23:730-733. [PMID: 23512445 DOI: 10.1007/s11695-013-0927-x] [Citation(s) in RCA: 61] [Impact Index Per Article: 5.1] [Reference Citation Analysis] [Abstract] [MESH Headings] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Indexed: 12/13/2022]
Abstract
The goal of this study was to evaluate the safety and the impact on weight loss of a new swallowable gastric balloon. In this prospective pilot study, 17 overweight or obese patients were included. Up to three balloons were ingested under fluoroscopic control. All balloons were removed by upper GI endoscopy, 12 weeks after the ingestion of the first balloon. 43 out of 44 attempts (98 %) to swallow a balloon were successful. Nausea and stomach pain were the most frequent side effects. Endoscopic procedures for balloon removal were uneventful. Weight loss was significant at weeks 4, 8, and 12. This pilot study showed no significant side effects induced by up to three balloons, and a significant weight loss.
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Affiliation(s)
- François Mion
- Department of Digestive Diseases, Hospices Civils de Lyon, Hôpital E. Herriot, Lyon, France.
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Singhal S, Le DL, Duddempudi S, Anand S. The role of endoscopy in bariatrics: past, present, and future. J Laparoendosc Adv Surg Tech A 2013; 22:802-11. [PMID: 23039704 DOI: 10.1089/lap.2012.0091] [Citation(s) in RCA: 6] [Impact Index Per Article: 0.5] [Reference Citation Analysis] [Abstract] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Indexed: 12/15/2022] Open
Abstract
The exponential increase in the rate of obesity and its associated co-morbidities has increased the demand for bariatric surgery. Over the past few decades, surgical weight reduction by gastric restriction, malabsorption, or a combination of both has been the preferred approach to achieve sustained weight loss in the morbidly obese. Although extremely effective, surgical procedures carry significant complications and risk with mortality rates of 1%. Because of the cost, surgical risk, and complications, there is a demand for less invasive procedures. Endoscopic approaches include placement of endoluminal space-occupying devices, stapling devices to reduce gastric volume, barrier devices to reduce small bowel absorptive area, and methods to regulate gastric emptying. Current and ongoing studies have delivered promising results across many aspects of endoscopic approaches. However, many technical obstacles still exist that have to be resolved with further research before endoscopic bariatrics can be widely deployed. At present the role of endoscopy is well established in preoperative evaluation as well as in recognition and management of many postoperative complications in bariatrics. In this article, we review the current and future endoscopic methods for weight reduction that are either in practice or in testing.
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Affiliation(s)
- Shashideep Singhal
- Division of Gastroenterology, Department of Internal Medicine, The Brooklyn Hospital Center, 121 Dekalb Avenue, Brooklyn, NY 11201, USA.
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20
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Malvoisin E. Detection of AMP-activated protein kinase α1 by isoelectric focusing in sera of patients with metabolic diseases. Electrophoresis 2012; 33:2828-32. [DOI: 10.1002/elps.201200092] [Citation(s) in RCA: 1] [Impact Index Per Article: 0.1] [Reference Citation Analysis] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Received: 02/12/2012] [Revised: 04/28/2012] [Accepted: 05/16/2012] [Indexed: 11/06/2022]
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Abstract
BACKGROUND The BioEnterics Intragastric Balloon (BIB) has been considered an effective, less invasive method for weight loss, as it provides a permanent sensation of satiety. However, various non-randomized studies suggest BIB is a temporary anti-obesity treatment, which induces only a short-term weight loss. The purpose of this study was to present data of 500 obese who, after BIB-induced weight reduction, were followed up for up to 5 years. METHODS The BioEnterics BIB was used, and remained for 6 months. At 6, 12, and 24 months post-removal (and yearly thereafter), all subjects were contacted for follow-up. RESULTS From 500 patients enrolled, 26 were excluded (treatment protocol interruption); 474 thus remained, having initial body weight of 126.16 ± 28.32 kg, BMI of 43.73 ± 8.39 kg/m2, and excess weight (EW) of 61.35 ± 25.41. At time of removal, 79 (17%) were excluded as having percent excessive weight loss (EWL) of <20%; the remaining 395 had weight loss of 23.91 ± 9.08 kg (18.73%), BMI reduction of 8.34 ± 3.14 kg/m2 (18.82%), and percent EWL of 42.34 ± 19.07. At 6 and 12 months, 387 (98%) and 352 (89%) presented with weight loss of 24.14 ± 8.93 and 16.31 ± 7.41 kg, BMI reduction of 8.41 ± 3.10 and 5.67 ± 2.55 kg/m2, and percent EWL of 42.73 ± 18.87 and 27.71 ± 13.40, respectively. At 12 and 24 months, 187 (53%) and 96 (27%) of 352 continued to have percent EWL of >20. Finally, 195 of 474 who completed the 60-month follow-up presented weight loss of 7.26 ± 5.41 kg, BMI reduction of 2.53 ± 1.85 kg/m2, and percent EWL of 12.97 ± 8.54. At this time, 46 (23%) retained the percent EWL at >20. In general, those who lost 80% of the total weight lost during the first 3 months of treatment succeeded in maintaining a percent EWL of >20 long term after BIB removal: more precisely, this cutoff point was achieved in 83% at the time of removal and in 53%, 27%, and 23% at 12-, 24-, and 60-month follow-up. CONCLUSION BIB seems to be effective for significant weight loss and maintenance for a long period thereafter, under the absolute prerequisite of patient compliance and behavior change from the very early stages of treatment.
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Kethu SR, Banerjee S, Barth BA, Desilets DJ, Kaul V, Pedrosa MC, Pfau PR, Pleskow DK, Tokar JL, Wang A, Song LMWK, Rodriguez SA. Endoluminal bariatric techniques. Gastrointest Endosc 2012; 76:1-7. [PMID: 22579259 DOI: 10.1016/j.gie.2012.02.020] [Citation(s) in RCA: 34] [Impact Index Per Article: 2.6] [Reference Citation Analysis] [Abstract] [MESH Headings] [Track Full Text] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Received: 02/17/2012] [Accepted: 02/17/2012] [Indexed: 12/20/2022]
Abstract
The American Society for Gastrointestinal Endoscopy (ASGE) Technology Committee provides reviews of new or emerging endoscopic technologies that have the potential to have an impact on the practice of GI endoscopy. Evidence-based methodology is used, with a MEDLINE literature search to identify pertinent preclinical and clinical studies on the topic and a MAUDE (U.S. Food and Drug Administration Center for Devices and Radiological Health) database search to identify the reported complications of a given technology. Both are supplemented by accessing the "related articles" feature of PubMed and by scrutinizing pertinent references cited by the identified studies. Controlled clinical trials are emphasized, but in many cases, data from randomized, controlled trials are lacking. In such cases, large case series, preliminary clinical studies, and expert opinions are used. Technical data are gathered from traditional and Web-based publications, proprietary publications, and informal communications with pertinent vendors. For this review, the MEDLINE database was searched through January 2011 using the keywords "bariatric," "endoscopic," "intragastric balloon," "duodenojejunal bypass sleeve," and "transoral gastroplasty." Reports on Emerging Technologies are drafted by 1 or 2 members of the ASGE Technology Committee, reviewed and edited by the committee as a whole, and approved by the Governing Board of the ASGE. These reports are scientific reviews provided solely for educational and informational purposes. Reports on Emerging Technologies are not rules and should not be construed as establishing a legal standard of care or as encouraging, advocating, requiring, or discouraging any particular treatment or payment for such treatment.
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Lecumberri E, Krekshi W, Matía P, Hermida C, de la Torre NG, Cabrerizo L, Rubio MÁ. Effectiveness and safety of air-filled balloon Heliosphere BAG® in 82 consecutive obese patients. Obes Surg 2012; 21:1508-12. [PMID: 21221835 DOI: 10.1007/s11695-010-0314-9] [Citation(s) in RCA: 32] [Impact Index Per Article: 2.5] [Reference Citation Analysis] [Abstract] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Indexed: 01/04/2023]
Abstract
BACKGROUND Intragastric balloon is a widely used technique to treat obesity that is considered to be more efficient than conservative treatment before bariatric surgery. To describe air-filled balloon (Heliosphere BAG®) effectiveness [absolute weight loss, body mass index (BMI) loss, percentage of body weight loss (BWL), percentage of excess weight loss (EWL)] and complications 6 months after its insertion. METHODS Eighty-four consecutive intragastric balloons were placed endoscopically. Individualized nutritional counseling was given. The follow-up was carried out in an endocrinology outpatient clinic. Due to the weight or height data missed in two cases, only 82 patients were included in this report, 63 women with a mean age 39 years (SD, 11.1); mean BMI, 39.1 kg/m(2) (SD, 5.8). The median follow-up was 182 days. RESULTS The mean weight loss and BMI loss were 14.5 kg (SD, 8.2); and 5.3 kg/m(2) (SD, 2.8), respectively (for difference, p < 0.001). The mean percentage of BWL was 13.4% (SD, 7.0). Of the sample, 70.4% achieved a percentage of BWL >10%. The percentage of EWL reached 33.2% (SD, 19.2). After adjusting by sex and initial BMI, absolute weight loss (p = 0.033), BMI loss (p = 0.034), percentage of BWL (p = 0.034), and percentage of EWL (p = 0.034) were inversely related to age. Absolute weight loss and BMI loss were greater in higher initial BMI, but the percentage of EWL was lower. Two spontaneous deflations occurred (3%), but only one surgical early removal (1.2%) was required. Nausea and vomiting developed in 7.4% of the patients during the first week. CONCLUSIONS Air-filled Heliosphere BAG® has been effective in achieving a relevant loss of body weight.
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Affiliation(s)
- Edurne Lecumberri
- Endocrinology and Nutrition Department, Fundación Jiménez Díaz-Capio, Avda. Reyes Católicos n 2, Madrid, Spain.
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Endoscopic treatment of obesity. CANADIAN JOURNAL OF GASTROENTEROLOGY = JOURNAL CANADIEN DE GASTROENTEROLOGIE 2012; 25:627-33. [PMID: 22059171 DOI: 10.1155/2011/174163] [Citation(s) in RCA: 24] [Impact Index Per Article: 1.8] [Reference Citation Analysis] [Abstract] [Track Full Text] [Subscribe] [Scholar Register] [Indexed: 12/22/2022]
Abstract
BACKGROUND The increasing incidence of obesity and overweight among children and adolescents will be reflected by the imminent increase in the number of obese patients who require more definitive methods of treatment. There is great interest in new, safe, simple, nonsurgical procedures for weight loss. OBJECTIVE To provide an overview of new endoscopic methods for the treatment of obesity. METHODS An English-language literature search on endoscopic interventions, endoscopically placed devices and patient safety was performed in the MEDLINE and Cochrane Library databases. RESULTS The literature search yielded the following weight loss methods: space-occupying devices (widely used), gastric capacity reduction, modifying gastric motor function and malabsorptive procedures. A commercially available intragastric balloon was the most commonly used device for weight loss. In specific subgroups of patients, it improved quality of life, decreased comorbidities and served as a bridge to surgery. More evidence regarding the potential benefits and safety of other commercially available intragastric balloons is needed to clarify whether they are superior to the most commonly used one. Moreover, early experiences with transoral gastroplasty, the duodenal-jejunal bypass sleeve and an adjustable, totally implantable intragastric prosthesis, indicate that they may be viable options for obesity treatment. Other agents, such as botulinum toxin and a device known as the 'butterfly', are currently at the experimental stage. CONCLUSION New endoscopic methods for weight loss may be valuable in the treatment of obesity; however, more clinical experience and technical improvements are necessary before implementing their widespread use.
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25
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Sioulas AD, Polymeros D, Kourikou A, Papanikolaou IS, Triantafyllou K. Intragastric balloon left in the stomach for more than a year: two case reports. Obes Facts 2012; 5:436-9. [PMID: 22797371 DOI: 10.1159/000341134] [Citation(s) in RCA: 2] [Impact Index Per Article: 0.2] [Reference Citation Analysis] [Abstract] [MESH Headings] [Track Full Text] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Received: 11/03/2011] [Accepted: 11/26/2011] [Indexed: 01/27/2023] Open
Abstract
OBJECTIVE Intragastric balloon (IGB) is often used to achieve short-term weight reduction in morbidly obese patients. It is placed endoscopically for a 6-month-period either in the pre-bariatric surgery setting and also in cases where no bariatric surgery is planned. Prolonged implantation may be accompanied by serious complications. CASE REPORTS We herein report two cases of extraction of intact IGBs long time after their placement. CONCLUSION Although no adverse events were observed, adherence to manufacturers' recommendations is definitely suggested.
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Affiliation(s)
- Athanasios D Sioulas
- Hepatogastroenterology Unit, 2nd Department of Internal Medicine-Propaedeutic, Attikon University General Hospital, Medical School, University of Athens, Haidari, Greece.
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Familiari P, Boškoski I, Marchese M, Perri V, Costamagna G. Endoscopic treatment of obesity. Expert Rev Gastroenterol Hepatol 2011; 5:689-701. [PMID: 22017697 DOI: 10.1586/egh.11.77] [Citation(s) in RCA: 8] [Impact Index Per Article: 0.6] [Reference Citation Analysis] [Abstract] [Track Full Text] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Indexed: 12/17/2022]
Abstract
Obesity is a worldwide epidemic, complex metabolic disease associated with a variety of severe comorbidities. Bariatric surgery provides the patients with the benefits of sustained weight loss and improves obesity-related comorbidities, but can result in potentially life-threatening complications. Gastrointestinal endoscopy has recently been proposed as a scarless and noninvasive approach to obesity. Most of the current endoluminal devices and techniques are comparable to restrictive surgery. A variety of medical devices and procedures have been evaluated in recent years; however, with the exception of the intragastric balloon, evaluation of all the other endoluminal procedures is limited by the numbers of patients treated, the short follow-up and especially by the study design. Today, only a few devices have been evaluated in randomized controlled trials. The preliminary results of the first studies are extremely promising, but definitive statements cannot be drawn yet.
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Affiliation(s)
- Pietro Familiari
- Digestive Endoscopy Unit, Agostino Gemelli University Hospital, Università Cattolica del Sacro Cuore, Roma, Italy
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Affiliation(s)
- Mark H. DeLegge
- Digestive Disease Center, Medical University of South Carolina, Charleston, South Carolina
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De Castro ML, Morales MJ, Del Campo V, Pineda JR, Pena E, Sierra JM, Arbones MJ, Prada IR. Efficacy, safety, and tolerance of two types of intragastric balloons placed in obese subjects: a double-blind comparative study. Obes Surg 2011; 20:1642-6. [PMID: 20390374 DOI: 10.1007/s11695-010-0128-9] [Citation(s) in RCA: 55] [Impact Index Per Article: 3.9] [Reference Citation Analysis] [Abstract] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Indexed: 12/16/2022]
Abstract
The intragastric balloon is a temporary treatment for obese patients. Fluid-filled devices have shown efficacy and safety, and are widely used. Recently, although there are no comparative studies between them, an air-filled balloon, Heliosphere® bag, has been proposed. Prospective, double-blind study in 33 patients with morbid and type 2 obesity: 23 female, 43.9±10 years, 120.3±17 kg, and body mass index (BMI) of 44.2±5 kg/m2, placing 18 gastric balloons filled with 960 cm3 of air (Heliosphere® bag) or 15 balloons filled with 700 ml of saline (Bioenterics-BIB®). Both balloons were placed with conscious sedation and removed under general anesthesia 6 months later. Intravenous drugs were given to control symptoms for 48 h. Patients were sent home on a 1000-kcal diet, multivitamin supplements, and oral proton pump inhibitors, and were followed monthly. Complications, symptoms, weight, and quality of life evaluated by the Gastrointestinal Quality of Life Index (GIQLI) scale were recorded. At 6 months, mean weight loss (12.8±8 vs 14.1±8 kg), BMI loss (4.6±3 vs 5.5±3 kg/m2) and percent excess weight loss (27±16 vs.30.2±17) showed no significant differences between both groups. At removal, two Heliosphere® bags were not found in the stomach, and four patients required extraction of the balloon by rigid esophagoscopy or surgery (p=0.02). Tolerance was good in both groups, but early removal occurred in three BIB® (20%) due to vomits and dehydration. The GIQLI total scores remained unchanged. Both balloons achieve a significant weight loss with good tolerance in obese patients. Nevertheless, Heliosphere® bag has severe technical problems that need to be solved before recommending it.
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Affiliation(s)
- Maria Luisa De Castro
- Department of Gastroenterology, Universitary Hospital of Vigo (CHUVI), Vigo, Galicia, Spain.
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Trande P, Mussetto A, Mirante VG, De Martinis E, Olivetti G, Conigliaro RL, De Micheli EA. Efficacy, tolerance and safety of new intragastric air-filled balloon (Heliosphere BAG) for obesity: the experience of 17 cases. Obes Surg 2010; 20:1227-1230. [PMID: 19082675 DOI: 10.1007/s11695-008-9786-2] [Citation(s) in RCA: 33] [Impact Index Per Article: 2.2] [Reference Citation Analysis] [Abstract] [MESH Headings] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Received: 07/02/2008] [Accepted: 11/20/2008] [Indexed: 12/25/2022]
Abstract
BACKGROUND Overweight and obesity lead to serious health consequences, so that many strategies were recommended for preventing or curing this emerging problem. Treatments are various: diet, physical activity, psychotherapy, drugs, and bariatric surgery. Moreover, during these years, the use of intragastric balloon (BIB) to treat obesity increased rapidly, aimed to (1) reduce bariatric surgical risks; (2) reduce general surgical risks; (3) lead to a significant reduction in the prevalence of cardiovascular diseases, diabetes, musculoskeletal disorders and some cancers. Recently, a new device inflated with air to reduce weight has been developed since 2004 (Heliosphere BAG). METHODS Between March 2006 and September 2006, in our unit, intragastric air-filled balloon insertion was performed under general anesthesia and endoscopic control. The balloons were removed after 6 months. We evaluated efficacy, tolerance, and safety of this technique. Seventeen patients (eight men, nine women), with a mean age of 43 +/- 10 years (range 18-65), mean basal BMI of 46 +/- 8 (range 35-58) were included, after providing informed consent. Weight and BMI loss were evaluated in all patients. RESULTS BMI decreased 4 +/- 3 (range +0.33/-11), weight loss was 11 +/- 9 kg (range +1/-29.5; 8.5%). 14/17 patients maintain a BMI > 35 at the time of balloon removal. The difference between initial weight and BMI was statistically significant (p = 0.02 for weight and p < 0.01 for BMI, T Student test). Tolerance was very good, limited only to some dyspeptic symptoms during the first 3 days after insertion. One asymptomatic gastric ulcer was seen at the removal of balloon. Only one severe adverse effect was registered at the time of insertion (acute coronary syndrome in patient with chronic coronary disease). No serious technical problems were noted at balloon insertion. Balloon removal was more difficult and successful in 15/17 cases (one distal migration and one patient led to surgery because of balloon fragmentation). CONCLUSION Intragastric air-filled balloon showed a good profile of efficacy and tolerance. Weight loss appeared to be equivalent to other type of balloons. On the other hand, technical problems (especially at the time of removal) probably linked to the device's material, set a low safety profile.
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Affiliation(s)
- Paolo Trande
- Internal Medicine and Gastroenterology Unit, New S'Agostino Hospital, Modena, Italy
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Konopko-Zubrzycka M, Baniukiewicz A, Wróblewski E, Kowalska I, Zarzycki W, Górska M, Dabrowski A. The effect of intragastric balloon on plasma ghrelin, leptin, and adiponectin levels in patients with morbid obesity. J Clin Endocrinol Metab 2009; 94:1644-9. [PMID: 19258408 DOI: 10.1210/jc.2008-1083] [Citation(s) in RCA: 60] [Impact Index Per Article: 3.8] [Reference Citation Analysis] [Abstract] [MESH Headings] [Track Full Text] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Indexed: 02/08/2023]
Abstract
CONTEXT Ghrelin and leptin are hormones regulating appetite and metabolic processes. Adiponectin plays an important role in the modulation of glucose and lipid metabolism. OBJECTIVE The objective of the study was to evaluate the levels of plasma ghrelin, leptin, and adiponectin in obese subjects treated with bioenterics intragastric balloon (BIB), low-calorie diet (1500 kcal), and physical exercise. DESIGN BIB was placed for 6 months in 21 subjects with body mass index 47.3 +/- 5.7. The control group consisted of 15 morbidly obese subjects treated with a low-calorie diet and physical effort. Plasma hormone levels were determined by RIA. RESULTS In the BIB group, the insertion of the balloon caused a considerable reduction in body mass over a 6-month period (17.1 +/- 8.0 kg) as compared with the control group (3.2 +/- 6.4 kg). After 1 month, the levels of ghrelin increased from 621.9 +/- 182.4 to 903.9 +/- 237 pg/ml and thereafter gradually decreased, reaching the starting level 3 months after the removal of the balloon. In the same group, the levels of leptin decreased from 61.3 +/- 36.7 to 39.9 +/- 17.5 ng/ml. In the control group, the corresponding levels of ghrelin and leptin remained relatively stable. During the observation period, in the BIB group, the levels of adiponectin remained unchanged as opposed to a transient increase noted in the control group. CONCLUSIONS In patients with morbid obesity, weight loss induced by BIB is associated with a decrease in plasma leptin and a transient elevation of plasma ghrelin. It is likely that the changes in hormones regulating the energy balance caused by BIB can prevent an increase in adiponectin level.
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Affiliation(s)
- M Konopko-Zubrzycka
- Department of Gastroenterology and Internal Medicine, Medical University of Bialystok, ul. Sklodowskiej-Curie 24A, PL-15-276 Bialystok, Poland
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Mui WLM, Ng EKW, Tsung BYS, Lam CH, Yung MY. Impact on obesity-related illnesses and quality of life following intragastric balloon. Obes Surg 2008; 20:1128-32. [PMID: 19015930 DOI: 10.1007/s11695-008-9766-6] [Citation(s) in RCA: 61] [Impact Index Per Article: 3.6] [Reference Citation Analysis] [Abstract] [MESH Headings] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Received: 08/19/2008] [Accepted: 10/29/2008] [Indexed: 12/22/2022]
Abstract
BACKGROUND The impact of intragastric balloon (IGB) on obesity-related illnesses and quality of life (QOL) has not been previously investigated. METHOD One hundred and nineteen consecutive obese patients (86 females; mean age 37.8; mean body weight (BW) 103.7 +/- 24.1 kg; mean BMI 38.4 +/- 8.0 kg/m(2)) who underwent IGB were evaluated for improvement on obesity-related illnesses and QOL after weight reduction in a multidisciplinary university referral center. Bioenterics Intragastric balloon (BIB system was employed in the study. RESULTS Mean treatment period was 169.9 +/- 34.8 days. Mean BW, BMI, and excess body weight loss were 12.4 +/- 6.9 kg, 4.6 +/- 2.7 kg/m(2), and 45.1 +/- 35.3%. Mean waist circumference and biceps fold and triceps fold loss were 10.5 +/- 8.3, 9.8 +/- 8.5, and 8.7 +/- 7.4 cm respectively. Metabolic syndrome was decreased from 42.9% to 15.1% after IGB (p < 0.0005). Improvement of obesity-related illnesses were significant in fasting glucose, cholesterol, triglyceride, C-reactive protein, and blood pressure (p < 0.005).In 28 diabetes patients, HBA1C level was significantly decreased as compared to baseline (7.4 vs. 5.8%; p < 0.0005). The QOL of patients was significantly improved after IGB (p < 0.05). No serious complication related to IGB was observed. Four patients (3.3%) had intolerance and required early removal of balloon. Thirty-one patients (26%) received further bariatric surgery after IGB. CONCLUSIONS IGB produces meaningful weight loss and significantly improves obesity-related illnesses and quality of life.
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Affiliation(s)
- Wilfred Lik-Man Mui
- Department of Surgery, Prince of Wales Hospital, The Chinese University of Hong Kong, Shatin, Hong Kong SAR, China.
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Evidence-based review of the Bioenterics intragastric balloon for weight loss. Obes Surg 2008; 18:1611-7. [PMID: 18568377 DOI: 10.1007/s11695-008-9593-9] [Citation(s) in RCA: 103] [Impact Index Per Article: 6.1] [Reference Citation Analysis] [Abstract] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Received: 04/30/2008] [Accepted: 05/23/2008] [Indexed: 12/13/2022]
Abstract
We reviewed clinical studies performed with the Bioenterics intragastric balloon (BIB) to promote weight loss. Thirty studies were included [18 prospective (5 randomized), 12 retrospective], totaling 4,877 patients. Only one of three sham-controlled trials found a significantly higher weight loss with the BIB vs the sham procedure plus exhaustive follow-up. In nonrandomized studies, weight loss with the BIB averaged 17.8 kg (range, 4.9-28.5), corresponding to BMI changes of 4.0-9.0 kg/m(2). Comorbidities resolved or improved in 52-100% of patients. Best short-term results were observed in patients devoid of binge eating disorder with a BMI in the 30.0-40.0 kg/m(2) range; the BIB also helped to prepare superobese patients for bariatric surgery. Severe complications were exceptional (gastric perforation and intestinal obstruction; 0.2% each); digestive intolerance prompted early BIB removal in 2.5% of patients. Long-term (>or=2 years) results are awaited, as well as well-designed studies to define the best indications for this therapy.
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Juchems MS, Uyak D, Ernst AS, Brambs HJ. Monitoring gastric filling, satiety and gastric emptying in a patient with gastric balloon using functional magnetic resonance imaging-a feasibility report. Clin Med Case Rep 2008; 1:41-4. [PMID: 24179344 PMCID: PMC3785374 DOI: 10.4137/ccrep.s781] [Citation(s) in RCA: 2] [Impact Index Per Article: 0.1] [Reference Citation Analysis] [Abstract] [Track Full Text] [Download PDF] [Figures] [Journal Information] [Subscribe] [Scholar Register] [Indexed: 11/11/2022] Open
Abstract
Backround Intragastric balloons are used for short term weight loss therapy in obese. It is possible to monitor the ballon with sonography, however this method is sometimes insufficient in obese patients. Therefore MRI seems to be a potential therapy-monitoring option. Purpose In this feasibility report we want to demonstrate the potential use of functional MRI in monitoring gastric filling, patient satiation and gastric emptying in a obese patient who previously received intragastric balloon placement. Material and methods We selected one patient (male, 178 cm, 127 kg, BMI = 40,5 kg/m2) who recently received a gastric balloon and visualized gastric motility in presence of the gastric balloon before and after food intake. Fast cross-sectional images in one breathhold spin echo or gradient echo sequences were aquired. Real-time gastric motion was performed with cine mode. Results MRI offers perfect visualisation of gastric balloons in obese patients. Gastric filling and emptying can be monitored in correlation to patient satiety sensation. MRI can visualize the gastric balloon with degree of filling and possible leakages. Cine mode sequences demonstrate gastric motility and gastric wall peristalsis. Conclusion MR is a valuable imaging alternative for patients with intragastric balloons
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Affiliation(s)
- Markus S Juchems
- Center for Diagnostic and Interventional Radiology, University Hospitals Ulm, Ulm, Germany
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