Rajeeb Jaleel ( Department of Gastroenterology, Christian Medical College, Vellore, India; )
Nitin Kapoor ( Department of Endocrinology, Diabetes and Metabolism, Christian Medical College, Vellore (TN) -632004, India, and Non Communicable Disease Unit, Melbourne School of Population and Global Health, Faculty of Medicine, Dentistry and Health Sciences, University of Melbourne, Melbourne, Victoria, Australia. )
Sanjay Kalra ( Department of Endocrinology, Bharti Hospital, Karnal, India. )
Endoscopic intra gastric balloon placement provides an alternative method for weight loss in patients who fail to respond to life style modification, diet restriction and pharmacological therapy. Intra gastric balloon (IGB), placement can be used as a temporary measure for weight loss in obesity with or without related complications or bridge therapy in morbid obesity prior to bariatric surgery. Weight loss achieved following IGB implantation depends on the type of balloon, medium, and filling volume used for IGB inflation. This brief review provides an overview of the indications, efficacy and safety of intragastric balloon treatment in patients with obesity.
Prevalence of obesity and overweight has increased rapidly across all age groups. Once considered a problem of developed countries overweight and obesity are now dramatically on the rise in low- and middle-income countries, particularly in urban settings. Though obesity is commonly managed by a combination therapy of calorie restricted diet, regular exercise and lifestyle modifications, but these measures seldom result in adequate weight loss. Approximate weight loss of 5-10 percent is required to delay or prevent the onset of diabetes and other obesity related complications.1 Currently various endoscopic and surgical treatment options are available for weight loss. Bariatric surgery is the most effective and durable treatment option for weight loss. However only less than 1% of eligible patients opt to undergo surgical procedure due to various reasons like high cost, access to care, the morbidity and mortality associated with surgical interventions.2 Therefore, in the last decade various endoscopic bariatric treatment (EBT) procedures have gained popularity as option for weight loss which includes intragastric balloons (IGB), endoscopic sleeve gastroplasty, aspiration therapy and gastrointestinal bypass sleeves. Among all the EBTs IGBs are most widely used in clinical practice.
Intragastric balloon - The concept
Is an inflatable medical device placed temporarily into stomach for inducing weight loss. First intragastric balloon for weight loss was introduced in 1985 by Garren-Edwards Gastric Bubble (GEGB), which was approved by US Food and drug administration (FDA) for temporary use. Approval for GEGB was withdrawn by FDA in 1992 due to associated complications like spontaneous deflation, intestinal obstruction and limited weight loss.3 Weight loss mechanism of IGBs are predominantly restrictive. Other possible mechanisms of weight loss are delayed gastric emptying, altered accommodation, and gastrointestinal neurohormonal release that alter satiety and satiation which lead to weight loss. Advantages of IGBs over other method of weight loss therapies are 1) Minimally invasive 2) reversible 3) repeatable 4) cost effective and 5) preserve the GI anatomy.4
Types of intragastric balloon
IGBs differ in their balloon material, filling media, balloon Volume, duration of treatment, technique of insertion and removal.
Two FDA approved IGBs are Orbera and Obalon. Non FDA approved IGBS are Spatz adjustable balloon system and Ellipse Gastric Balloon system.
1. Orbera: Previously known as BioEnterics Intragastric Balloon (BIB) was introduced in 1990s, is the most used IGB worldwide (Apollo Endosurgery, Austin, Tex). It is an elastic silicone balloon filled with 400 – 700ml of methylene mixed saline which is introduced into stomach on a preloaded catheter under direct vision. IGB is inflated with under endoscopic guidance. Orbera Balloon is placed in stomach for duration of 6 months following it is endoscopically removed. Saline is mixed with methylene blue to alert rupture or deflation of Balloon, that is identified by change in colour of urine to greenish blue due to systemic absorption of methylene blue dye.
2. Obalon gastric balloon: Obalon system is packaged within gelatin capsule. The capsule with balloon is swallowed while the attached catheter extends from stomach to mouth. Capsule is dissolved and balloon is filled with maximum of 250 ml air. Three separate Obalon balloons can be swallowed simultaneously and sequentially for duration of 6 months.
3. Spatz adjustable balloon system: Saline filled balloon with extractable inflation tube for volume adjustment while IGB remains in the stomach. Spatz balloon can reside in stomach upto 1 year.
4. Ellipse Gastric Balloon system: Ellipse balloon is enclosed in capsule with long thin catheter that remain outside the mouth after swallowing. Balloon is filled with 550ml of fluid. And the balloon degrades after 4 months and is excreted naturally. Ellipse balloon can be used in patients who wish to avoid gastroscopy and anaesthesia.
Indications and Contraindications
IGB is an option for weight loss in following categories of patient who have failed to achieve targeted weight loss despite supervised diet and exercise alone
a) Eligibility to undergo IGB placement are patients with BMI of 30-35 kg/m2 with obesity related medical illness. This category of patients are not eligible for bariatric surgery. Early intervention with IGB will help these patients prevent or treat from developing obesity related complications.5
b) Patients with BMI 35-40 kg/m2 with obesity related complications or BMI >40 kg/m2 are eligible for bariatric surgery. IGB can be used to induce weight loss in these patients due to high risk of the procedure, lack of access to procedure and also due to high cost. IGB can also be used as bridging therapy prior to surgery.5
Contraindications for IGB placement: Patients being planned to undergo IGB placement should be screened for potential contraindications (Table).6
Weight loss efficacy
Total body weight loss (TBWL) following intra gastric balloon therapy ranges between 6-15%.7Kotzampassi et al in their 5 year follow up study of 500 patients showed weight loss of 23.91±9.08 kg (18.7%), BMI reduction of 8.34±3.1 kg/m2 (18.8%), and percent EWL of 42.3±19.07 at the time of removal of IGB.8 And at 12 and 24 months of post removal of IGB, 187 (53%) and 96 (27%) of 352 continued to have percent EWL of >20.8 A trial of 125 patients who underwent Orbera intragastric balloon (OIB) was compared with 135 patients who underwent life style modifications alone. The %TBWL among completers at 6 months in the OIB group (n=116) was 10.7%+6.8% compared with 4.7%+6 5% in the control group (n=99).9 OIB was most effective during the first 3 months of therapy. A meta-analysis found greater weight loss with liquid-filled than air-filled balloons.10
Improvement in metabolic parameters following IGB: IGB therapy has shown significant short term reduction most metabolic parameters. When compared to lifestyle changes IGB showed fasting glucose improved by 12.7 mg/dL (95% CI: 221.5, 24), triglycerides by 19 mg/dL (95% CI: 242, 23.5), waist circumference by 4.1 cm (95% CI: 26.9, 21.4), and diastolic blood pressure by 2.9 mm Hg (95% CI: 24.1, 21.8) over lifestyle intervention alone. The odds ratio for diabetes resolution after IGB therapy was 1.4 (95% CI: 1.3, 1.6).11 Liver fibrosis resolution was seen in 10% of patients after 6 months of IGB therapy.12
Nearly 90% of patients who undergo IGB placement experience some form of adverse effect. Common adverse events are abdominal pain, nausea, vomiting, dyspeptic symptoms and constipation. Patients are started on proton pump inhibitors, antiemetics (Aprepitant) prior to IGB insertion. Anticholinergic (Hyoscine Butyl bromide) is used in first week of IGB insertion to treat abdominal pain. Serious adverse events are rare which include balloon migration, balloon hyperinflation, acute pancreatitis and gastric ulceration.
Intragastric balloon offer a minimally invasive and effective method to achieve weight loss and prevent or treat associated complications without altering anatomy. In addition to weight loss IGB insertion has shown improvement in metabolic parameters and quality of life. Future of obesity treatment will include a multi-disciplinary approach involving life style modifications, diet restriction, medications, counselling, bariatric endoscopy and surgery in personalized and step-up model.
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