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- 1. eNDOBARIATRIX XX INTRA GASTRIC BALLOONS Dr. RAJIV PRAKASH MANEK F E L L O W D I G E S T I V E S U R G E R Y Y O T S U Y A M E D I C A L C U B E J A P A N
- 2. Obesity Burden 2016 WHO report • 1.9 billion adults OVERWEIGHT • 650 million adults OBESE
- 3. Obesity increases • Diabetes mellitus • Hypertension • Coronary Artery Disease • Sleep Apnea • Stroke • Gastroesophageal Reflux Disease • Gall Bladder Disease • Certain Cancers • Non Alcoholic Fatty Liver Disease
- 4. Treatment • Lifestyle modifications • Exercise • Diet • Pharmacotherapy • Surgery…
- 5. Surgery • Most EFFECTIVE and DURABLE treatment option • Only 1 % of eligible morbid obesity patients undergo surgery Less acceptability because of • Cost • Availability • Complications • Patient preference
- 7. HISTORY • Garren-Edwards Gastric Bubble 1985 (USA) Polyurethane Cylindrical 200-220ml of Air Complications Small bowel obstruction Gastric mucosal injury
- 8. INDICATIONS • Preemptive therapy BMI ≥ 30kg/m2 at risk of disease development At risk for high all cause mortality With high cardiovascular risk profile • Metabolic therapy BMI ≥ 30kg/m2 with hyperlipidemia, type 2 diabetes mellitus and hypertension • Primary therapy BMI ≥ 35kg/m2 BMI ≥ 40kg/m2 as a preparation for bariatric surgery or not wanting surgery
- 11. Orbera • Apollo Endosurgery, USA • Previously Bioenterics Intragastric Balloon(BIB) • Silicone balloon • 450-700ml Saline + Methylene blue • 6 months use • FDA approval August 6th, 2015
- 12. ReShape Duo • ReShape Medical, USA • 900ml of saline distributed equally to each of two balloons (450ml-450ml) • If one ruptures other can sustain location in the stomach • 6 months • FDA approval July 2015
- 13. Spatz Adjustable Balloon • Spatz Medical, USA • 400-800ml Saline + Methylene Blue • 12 months • CE approval • ADJUSTABLE
- 14. Elipse • Allurion Technologies, USA • Procedureless • Swallowable • Self draining • Naturally expelled • 4 months
- 15. Obalon • Obalon Therapeutics, USA • Swallowable • 250ml Air • FDA approved • Upto 3 can be used over 6 months
- 16. Heliosphere Bag • Helioscopie, France • Double bagged polymer • External silicone pouch • 700ml Air • Weight < 30gm • 6 months
- 17. EFFECTS • Weight loss • Co-morbidity resolution • Alterations in Gastrointestinal Hormones
- 18. Weight Loss • Orbera balloon therapy – Mean Weight Loss 3 months 10.5 - 13.7 kg 6 month 13 - 26.3 kg • Excess Weight Loss at 6 months after removal 14 % - 50.9 % • Excess Weight Loss at 12 months after removal 14.2 % - 27.2 %
- 19. • Orbera was most effective during first 3 months of placement with 80 % of total achieved weight reduction • Insertion of second Orbera balloon not difficult and achieved good results • % Excess Weight Loss being 31.5 ± 23.2 %
- 20. • Reshape duo has a Total Body Weight reduction of 16.6 ± 9.33 kg at 6 months • Mean Excess weight Loss of 31.8 % at 6 months • 64 % of the reduced body weight was maintained at 6 months of removal
- 21. • Spatz adjustable balloon showed Mean Weight Loss of 15.6 kg at 24 weeks and 24.4 kg at 52 weeks • A small observational investigation in 73 patients showed 45.7% of EWL at 12 months after placement
- 22. Co-Morbidity Resolution ORBERA AT INSERTION AT REMOVAL AFTER 6 MONTHS AT 6 MONTHS FOLLOW UP AT 1 YEAR FOLLOW UP METABOLIC SYNDROME 34.8 % 14.5 % 13 % 11.6 % DIABETES MELLITUS TYPE 2 32.6 % 20.9 % 22.5 % 21.3 % HYPERURICEMIA 26.1 % 25.4 % 25.9 % 26.4 % HYPERTRIGLYCERIDEMIA 37.7 % 14.5 % 15.2 % 17.4 % HYPERCHOLESTEROLEMI A 33.4 % 16.7 % 16.7 % 18.9 %
- 23. Obstructive Sleep Apnea • Obesity is a major risk factor for Obstructive Sleep Apnea with prevalence of 50 – 60 % • 17 patients with severe OSA underwent Orbera insertion for 6 months • Neck circumference decreased from 51.1 cm to 47.9 cm • Nearly complete resolution of OSA as evidenced by a decrease in the apnea-hypopnea index from 52.1 evets/hour to 14.0 events/hour
- 24. NAFLD • NAFLD affects about 70 % of OBESE patients • 18 obese patients with histologically proven Non Alcoholic Steato Hepatitis underwent Orbera insertion • At 6 months, significant reduction in mean BMI and superior improvement in Non Alcoholic Fatty Liver Disease Activity Scores
- 25. Infertility • Obesity is linked to Infertility in Obese Women • 110 obese infertile women evaluated for effectiveness of weight loss with the Orbera balloon and surgical techniques including the adjustable gastric band, sleeve gastrectomy and gastric bypass in restoring fertility • All procedures were effective in reversing infertility with no significant difference between them
- 26. CLINICAL DILLEMA • Since Orbera is the oldest balloon, most of the literature available is on Orbera (previously Bioenterics Intragastric Balloon)
- 27. How to choose ? • Good Response/Success Rate • Weight loss comparable to Bariatric Surgery • Effective Co-morbidity Resolution
- 28. SPATZ3 FDA TRIAL REPORT Intragastric Balloon FDA Obalon FDA Reshape FDA Orbera FDA Trans Pyloric Shuttle FDA Spatz3 Response / Success Rate (> 10% TBL or > 25% EWL) 24.7% 48.8% 46.4% 38.7% 83.7% % TBL (Total Body Weight Loss) 6.6% 6.8% 10.2% 9.4% 14.9% % EWL (Excess Weight Loss) 24.1% 25.1% 38% 30.2% 52.9% Weight Loss 14.4 lbs 14.3 lbs 21.8 lbs 20.5 lbs 31.7 lbs Added weight loss after up adjustment - - - - Additional 14.7% EWL