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Intragastric Balloons and Aspiration Therapy

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Gastrointestinal Interventional Endoscopy

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Abstract

The disease obesity continues to be a major health issue in the United States and abroad due to its prevalence and associated comorbidities. Treatment has consisted of lifestyle intervention, pharmacotherapy, and surgery; however, this treatment paradigm has not resulted in a decrease in the prevalence of obesity in the United States. The Food and Drug Administration (FDA) has recently approved four gastric endoscopic bariatric therapies (EBTs) for the primary treatment of obesity. These include three intragastric balloons (IGBs) (the ReShape Dual Balloon, the Orbera Balloon System, and the Obalon Balloon System) and the ASpireAssist System. These therapies provide additional options for treatment of obesity. They provide more weight loss than lifestyle intervention and pharmacotherapy, but less weight loss than bariatric surgery. However, they are also less invasive and carry less risk than bariatric surgery, which may make EBTs a more acceptable treatment to many patients.

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References

  1. Ward ZJ, Long MW, Resch SC, Gortmaker SL, Cradock AL, Giles C, et al. Redrawing the US obesity landscape: bias-corrected estimates of state-specific adult obesity prevalence. PLoS One. 2016;11(3):e0150735.

    Article  PubMed  PubMed Central  CAS  Google Scholar 

  2. Jensen MD, Ryan DH, Apovian CM, Ard JD, Comuzzie AG, Donato KA, et al. 2013 AHA/ACC/TOS guideline for the management of overweight and obesity in adults: a report of the American College of Cardiology/American Heart Association Task Force on Practice Guidelines and The Obesity Society. Circulation. 2014;129(25 Suppl 2):S102–38.

    Article  PubMed  Google Scholar 

  3. Turk MW, Yang K, Hravnak M, Sereika SM, Ewing LJ, Burke LE. Randomized clinical trials of weight loss maintenance: a review. J Cardiovasc Nurs. 2009;24(1):58–80.

    Article  PubMed  PubMed Central  Google Scholar 

  4. Schauer PR, Kashyap SR, Wolski K, Brethauer SA, Kirwan JP, Pothier CE, et al. Bariatric surgery versus intensive medical therapy in obese patients with diabetes. N Engl J Med. 2012;366(17):1567–76.

    Article  CAS  PubMed  PubMed Central  Google Scholar 

  5. Buchwald H, Oien DM. Metabolic/bariatric surgery worldwide 2011. Obes Surg. 2013;23(4):427–36.

    Article  PubMed  Google Scholar 

  6. Chang SH, Stoll CR, Song J, Varela JE, Eagon CJ, Colditz GA. The effectiveness and risks of bariatric surgery: an updated systematic review and meta-analysis, 2003-2012. JAMA Surg. 2014;149(3):275–87.

    Article  PubMed  PubMed Central  Google Scholar 

  7. Ponce J, DeMaria EJ, Nguyen NT, Hutter M, Sudan R, Morton JM. American Society for Metabolic and Bariatric Surgery estimation of bariatric surgery procedures in 2015 and surgeon workforce in the United States. Surg Obes Relat Dis. 2016;12(9):1637–9.

    Article  PubMed  Google Scholar 

  8. Kirby DF, Wade JB, Mills PR, Sugerman HJ, Kellum JM, Zfass AM, et al. A prospective assessment of the Garren-Edwards gastric bubble and bariatric surgery in the treatment of morbid obesity. Am Surg. 1990;56(10):575–80.

    CAS  PubMed  Google Scholar 

  9. Geliebter A, Westreich S, Gage D. Gastric distention by balloon and test-meal intake in obese and lean subjects. Am J Clin Nutr. 1988;48(3):592–4.

    Article  CAS  PubMed  Google Scholar 

  10. Gómez V, Woodman G, Abu Dayyeh BK. Delayed gastric emptying as a proposed mechanism of action during intragastric balloon therapy: results of a prospective study. Obesity. 2016;24(9):1849–53.

    Article  PubMed  Google Scholar 

  11. Mathus-Vliegen EM, de Groot GH. Fasting and meal-induced CCK and PP secretion following intragastric balloon treatment for obesity. Obes Surg. 2013;23(5):622–33.

    Article  PubMed  Google Scholar 

  12. Mion F, Napoleon B, Roman S, Malvoisin E, Trepo F, Pujol B, et al. Effects of intragastric balloon on gastric emptying and plasma ghrelin levels in non-morbid obese patients. Obes Surg. 2005;15(4):510–6.

    Article  PubMed  Google Scholar 

  13. Sumithran P, Prendergast LA, Delbridge E, Purcell K, Shulkes A, Kriketos A, et al. Long-term persistence of hormonal adaptations to weight loss. N Engl J Med. 2011;365(17):1597–604.

    Article  CAS  PubMed  Google Scholar 

  14. Kotzampassi K, Grosomanidis V, Papakostas P, Penna S, Eleftheriadis E. 500 Intragastric balloons: what happens 5 years thereafter? Obes Surg. 2012;22(6):896–903.

    Article  PubMed  Google Scholar 

  15. Courcoulas A, Abu Dayyeh BK, Eaton L, Robinson J, Woodman G, Fusco M, et al. Intragastric balloon as an adjunct to lifestyle intervention: a randomized controlled trial. Int J Obes. 2017;41(3):427–33.

    Article  CAS  Google Scholar 

  16. FDA. Summary of safety and effectiveness data (SSED) Obalon balloon system. In: FDA, editor. 2016. p. 1–46. https://fda.report/PMA/P160001/16/P160001B.pdf.

  17. FDA. Summary of safety and effectiveness data (SSED) ORBERA intragastric balloon system. In: FDA, editor. 2015. p. 1–32. https://www.accessdata.fda.gov/cdrh_docs/pdf14/P140008b.pdf.

  18. Genco A, Bruni T, Doldi SB, Forestieri P, Marino M, Busetto L, et al. BioEnterics Intragastric balloon: the Italian experience with 2,515 patients. Obes Surg. 2005;15(8):1161–4.

    Article  CAS  PubMed  Google Scholar 

  19. Abu Dayyeh BK, Eaton LL, Woodman G, Fusco M, Shayani V, Billy HT, et al. 444 A randomized, multi-center study to evaluate the safety and effectiveness of an intragastric balloon as an adjunct to a behavioral modification program, in comparison with a behavioral modification program alone in the weight management of obese subjects. Gastrointest Endosc. 2015;81(5 Suppl):AB147.

    Article  Google Scholar 

  20. Abu Dayyeh BK, Kumar N, Edmundowicz SA, Jonnalagadda S, Larsen M, Sullivan S, et al. ASGE Bariatric Endoscopy Task Force systematic review and meta-analysis assessing the ASGE PIVI thresholds for adopting endoscopic bariatric therapies. Gastrointest Endosc. 2015;82(3):425–38 e5.

    Article  PubMed  Google Scholar 

  21. Ginsberg GG, Chand B, Cote GA, Dallal RM, Edmundowicz SA, Nguyen NT, et al. A pathway to endoscopic bariatric therapies. Gastrointest Endosc. 2011;74(5):943–53.

    Article  PubMed  Google Scholar 

  22. Dumonceau JM, Francois E, Hittelet A, Mehdi AI, Barea M, Deviere J. Single vs repeated treatment with the intragastric balloon: a 5-year weight loss study. Obes Surg. 2010;20(6):692–7.

    Article  PubMed  Google Scholar 

  23. Lopez-Nava G, Rubio MA, Prados S, Pastor G, Cruz MR, Companioni E, et al. BioEnterics(R) intragastric balloon (BIB(R)). Single ambulatory center Spanish experience with 714 consecutive patients treated with one or two consecutive balloons. Obes Surg. 2011;21(1):5–9.

    Article  PubMed  Google Scholar 

  24. Genco A, Cipriano M, Bacci V, Maselli R, Paone E, Lorenzo M, et al. Intragastric balloon followed by diet vs intragastric balloon followed by another balloon: a prospective study on 100 patients. Obes Surg. 2010;20(11):1496–500.

    Article  PubMed  Google Scholar 

  25. Genco A, Lopez-Nava G, Wahlen C, Maselli R, Cipriano M, Sanchez MM, et al. Multi-centre European experience with intragastric balloon in overweight populations: 13 years of experience. Obes Surg. 2013;23(4):515–21.

    Article  PubMed  Google Scholar 

  26. Vargas EJ, Kadouh HC, Bazerbachi F, Acosta Cardenas AJ, Lorentz PA, Pesta CM, et al. 547 Single fluid-filled intragastric balloon for weight loss: us post-regulatory approval multicenter clinical experience in 245 patients. Gastrointest Endosc. 2017;85(5):AB82.

    Article  Google Scholar 

  27. https://www.fda.gov/MedicalDevices/Safety/LetterstoHealthCareProviders/ucm570707.htm.

  28. Aljiffry M, Habib R, Kotbi E, Ageel A, Hassanain M, Dahlan Y. Acute pancreatitis: a complication of intragastric balloon. Surg Laparosc Endosc Percutan Tech. 2017;27(6):456–9.

    Article  PubMed  Google Scholar 

  29. http://ir.apolloendo.com/press-release/company/apollo-endosurgery-provides-update-and-clarity-fda-letter-health-care.

  30. FDA. Summary of safety and effectiveness data (SSED) ReShape integrated dual balloon system; 2015. p. 1–43. https://www.accessdata.fda.gov/cdrh_docs/pdf14/p140012b.pdf.

  31. Ponce J, Woodman G, Swain J, Wilson E, English W, Ikramuddin S, et al. The REDUCE pivotal trial: a prospective, randomized controlled pivotal trial of a dual intragastric balloon for the treatment of obesity. Surg Obes Relat Dis. 2015;11(4):874–81.

    Article  PubMed  Google Scholar 

  32. Lopez-Nava G, Bautista-Castaño I, Jimenez-Baños A, Fernandez-Corbelle JP. Dual intragastric balloon: single ambulatory center Spanish experience with 60 patients in endoscopic weight loss management. Obes Surg. 2015;25(12):2263–7.

    Article  CAS  PubMed  Google Scholar 

  33. Bennett MC, Early DS, Sullivan SA, Maday RE, Bell SM, Mullady D, et al. Sa2020 Comparison of two intragastric balloon systems for weight loss in a clinical setting. Gastrointest Endosc. 2017;85(5):AB280.

    Article  Google Scholar 

  34. Curry T, Pitt T. Sa2016 Intragastric balloon intolerance: a retrospective review of 100 patients treated with two different devices. Gastrointest Endosc. 2017;85(5):AB277–AB8.

    Article  Google Scholar 

  35. Sullivan S, Woodman G, Edmundowicz S, Hassanein T, Shayani V, Fang JC, Noar M, Eid G, English WJ, Tariq N, Larsen M, Jonnalagadda SS, Riff DS, Ponce J, Early D, Volkmann E, Ibele AR, Spann MD, Krishnan K, Bucobo JC, Pryor A. Randomized sham-controlled trial of the 6-month swallowable gas-filled intragastric balloon system for weight loss. Surg Obes Relat Dis. 2018;14(12):1876–89.

    Article  PubMed  Google Scholar 

  36. Sullivan S, Swain JM, Woodman G, Edmundowicz S, Hassanein TI, Shayani V, et al. 812d The Obalon Swallowable 6-month balloon system is more effective than moderate intensity lifestyle therapy alone: results from a 6- month randomized sham controlled trial. Gastroenterology. 2016;150(4):S1267.

    Article  Google Scholar 

  37. De Peppo F, Caccamo R, Adorisio O, Ceriati E, Marchetti P, Contursi A, et al. The Obalon swallowable intragastric balloon in pediatric and adolescent morbid obesity. Endosc Int Open. 2017;5(1):E59–63.

    Article  PubMed  PubMed Central  Google Scholar 

  38. Machytka E, Klvana P, Kornbluth A, Peikin S, Mathus-Vliegen LEM, Gostout C, et al. Adjustable intragastric balloons: a 12-month pilot trial in endoscopic weight loss management. Obes Surg. 2011;21(10):1499–507.

    Article  PubMed  PubMed Central  Google Scholar 

  39. Brooks J, Srivastava ED, Mathus-Vliegen EM. One-year adjustable intragastric balloons: results in 73 consecutive patients in the UK. Obes Surg. 2014;24(5):813–9.

    Article  CAS  PubMed  Google Scholar 

  40. Machytka E, Divi VP, Saenger F, Sorio R, Brooks J. Mo1296a adjustable balloons for weight loss: a higher yield of responders compared with non-adjustable balloons. Gastrointest Endosc. 2017;85(5):AB495.

    Article  Google Scholar 

  41. Chuttani R, Machytka E, Raftopoulos I, Bojkova M, Kupka T, Buzga M, et al. 102 The first procedureless gastric balloon for weight loss: final results from a multi-center, prospective study evaluating safety, efficacy, metabolic parameters, quality of life, and 6-month follow-up. Gastroenterology. 2016;150(4):S26.

    Article  Google Scholar 

  42. Genco A, Ernesti I, Ienca R, Casella G, Mariani S, Francomano D, et al. Safety and efficacy of a new swallowable intragastric balloon not needing endoscopy: early Italian experience. Obes Surg. 2018;28(2):405–9.

    Article  CAS  PubMed  Google Scholar 

  43. 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 (London, England). 2017;48:16–22.

    Article  Google Scholar 

  44. Alsabah S, Al Haddad E, Ekrouf S, Almulla A, Al-Subaie S, Al Kendari M. The safety and efficacy of the procedureless intragastric balloon. Surg Obes Relat Dis. 2018;14(3):311–7.

    Article  PubMed  Google Scholar 

  45. Sullivan S, Stein R, Jonnalagadda S, Mullady D, Edmundowicz S. Aspiration therapy leads to weight loss in obese subjects: a pilot study. Gastroenterology. 2013;145(6):1245–52.e5.

    Article  PubMed  Google Scholar 

  46. Thompson CC, Abu Dayyeh BK, Kushner R, Sullivan S, Schorr AB, Amaro A, et al. Percutaneous gastrostomy device for the treatment of class II and class III obesity: results of a randomized controlled trial. Am J Gastroenterol. 2017;112(3):447–57.

    Article  PubMed  Google Scholar 

  47. Machytka E, Turro R, Huberty V, Buzga M, Bojkova M, Espinos JC, et al. Mo1944 Aspiration therapy in super obese patients – pilot trial. Gastroenterology. 2016;150(4):S822–S3.

    Article  Google Scholar 

  48. Nyström M, Machytka E, Norén E, Testoni PA, Janssen I, Turró Homedes J, et al. Aspiration therapy as a tool to treat obesity: 1- to 4-year results in a 201-patient multi-center post-market European Registry Study. Obes Surg. 2018;28:1860.

    Article  PubMed  PubMed Central  Google Scholar 

  49. Wilson E, Noren E, Axelsson L, Nystrom M, Gruvaes J, Paradis C, et al. A comparative 100-participant 5-year study of aspiration therapy versus roux-en-Y gastric bypass: first year results. Surg Obes Relat Dis. 2107;13(10):S25–S6.

    Article  Google Scholar 

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Author information

Authors and Affiliations

  1. Division of Gastroenterology, University of Colorado-Denver, Aurora, CO, USA

    Chetan Mittal

  2. University of Colorado School of Medicine, Aurora, CO, USA

    Shelby Sullivan

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  1. Chetan Mittal
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  2. Shelby Sullivan
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Correspondence to Shelby Sullivan .

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Editors and Affiliations

  1. Interventional Endoscopy, Division of Gastroenterology, University of Colorado-Denver, Aurora, CO, USA

    Mihir S. Wagh

  2. Interventional Endoscopy, Division of Gastroenterology, University of Colorado-Denver, Aurora, CO, USA

    Sachin B. Wani

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Mittal, C., Sullivan, S. (2020). Intragastric Balloons and Aspiration Therapy. In: Wagh, M., Wani, S. (eds) Gastrointestinal Interventional Endoscopy. Springer, Cham. https://doi.org/10.1007/978-3-030-21695-5_12

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  • DOI: https://doi.org/10.1007/978-3-030-21695-5_12

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  • Online ISBN: 978-3-030-21695-5

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