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Endoscopic Bariatric Therapies: Intragastric Balloons, Tissue Apposition, and Aspiration Therapy

  • Endoscopy (P Siersema, Section Editor)
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Current Treatment Options in Gastroenterology Aims and scope Submit manuscript

Abstract

Purpose of review

Endoscopic bariatric therapies (EBTs) have been identified as a group of procedures that can bridge the treatment gap between bariatric surgical procedures and non-procedural treatments such as pharmacotherapy and lifestyle therapy. We will review the recent progress that has been made in this important area in the past several years.

Recent findings

Traditional intragastric balloons (IGB) that are both placed and removed endoscopically have been the fixture of IGB therapy. They have been shown to be safe and effective, when kept in place for 6 months. Newer IGBs, both currently FDA approved and those in clinical trials, have unique features. The Obalon gastric balloon system is gas filled and does not require endoscopy for placement. The Elipse balloon system that is in clinical trials neither requires endoscopy for placement nor removal. The Spatz3 balloon is in clinical trials and can be adjusted endoscopically by adding or subtracting volume to titrate balloon volume to symptoms and weight loss. In addition to IGBs, several other promising therapies have continued to evolve. Endoscopic sleeve gastroplasty (ESG) is a promising gastric restriction technique that has efficacy and durability. POSE is a gastric plication technique that is available in Europe and in clinical trials in the USA. Aspiration therapy is a novel approach to weight loss that requires patient compliance but can be very effective and used long term.

Summary

EBTs are an evolving effective and safe approach for patients who do not qualify for or do not want bariatric surgery. There are multiple EBTs currently FDA approved as well as prospective endoscopic therapies in clinical trials that appear promising.

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References and Recommended Reading

Papers of particular interest, published recently, have been highlighted as: • Of importance •• Of major importance

  1. •• 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. https://doi.org/10.1038/ajg.2016.500 This is the first, randomized, controlled trial evaluating aspiration therapy.

    Article  PubMed  Google Scholar 

  2. 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. https://doi.org/10.1016/j.soard.2014.12.006.

    Article  PubMed  Google Scholar 

  3. Farina MG, Baratta R, Nigro A, Vinciguerra F, Puglisi C, Schembri R, et al. Intragastric balloon in association with lifestyle and/or pharmacotherapy in the long-term management of obesity. Obes Surg. 2012;22(4):565–71. https://doi.org/10.1007/s11695-011-0514-y.

    Article  PubMed  Google Scholar 

  4. Force ABET, Sullivan S, Kumar N, Edmundowicz SA, Abu Dayyeh BK, Jonnalagadda SS, et al. ASGE position statement on endoscopic bariatric therapies in clinical practice. Gastrointest Endosc. 2015;82(5):767–72. https://doi.org/10.1016/j.gie.2015.06.038.

    Article  Google Scholar 

  5. 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. https://doi.org/10.1001/jamasurg.2013.3654.

    Article  PubMed  PubMed Central  Google Scholar 

  6. US Food and Drug Administration. Summary of safety and effectiveness data (SSED) ReShape Integrated Dual Balloon System. 2015. https://www.accessdata.fda.gov/cdrh_docs/pdf14/P140012b.pdf. Accessed 2 Jan 2019.

  7. Agnihotri A, Xie A, Bartalos C, Kushnir V, Islam S, Islam E, et al. Real-world safety and efficacy of fluid-filled dual intragastric balloon for weight loss. Clin Gastroenterol Hepatol. 2018;16(7):1081–8 e1. https://doi.org/10.1016/j.cgh.2018.02.026.

    Article  PubMed  Google Scholar 

  8. US Food and Drug Administration. Summary of safety and effectiveness data (SSED) ORBERA Intragastric Balloon System. 2015. https://www.accessdata.fda.gov/cdrh_docs/pdf14/P140008b.pdf. Accessed 2 Jan 2019.

  9. 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. https://doi.org/10.1038/ijo.2016.229.

    Article  CAS  Google Scholar 

  10. Vargas EJ, Pesta CM, Bali A, Ibegbu E, Bazerbachi F, Moore RL, et al. Single fluid-filled intragastric balloon safe and effective for inducing weight loss in a real-world population. Clin Gastroenterol Hepatol. 2018;16(7):1073–80 e1. https://doi.org/10.1016/j.cgh.2018.01.046.

    Article  PubMed  PubMed Central  Google Scholar 

  11. •• Sullivan S, Swain J, Woodman G, Edmundowicz S, Hassanein T, Shayani V, et al. 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. https://doi.org/10.1016/j.soard.2018.09.486 This is the first randomized sham-controlled trial of a swallowable gas-filled balloon.

    Article  PubMed  Google Scholar 

  12. • Moore RL, Seger MV, Garber SM, Smith AB, Nguyen RT, Shieh MK, et al. Clinical safety and effectiveness of a swallowable gas-filled intragastric balloon system for weight loss: consecutively treated patients in the initial year of US commercialization. Surg Obes Relat Dis. 2018. https://doi.org/10.1016/j.soard.2018.12.007 This report analyzes patients in a prospective registry of patients in all practice types who underwent Obalon placement in its first year of availability in the USA.

    Article  PubMed  Google Scholar 

  13. •• Machytka E, Gaur S, Chuttani R, Bojkova M, Kupka T, Buzga M, et al. Elipse, the first procedureless gastric balloon for weight loss: a prospective, observational, open-label, multicenter study. Endoscopy. 2017;49(2):154–60. https://doi.org/10.1055/s-0042-119296 This is the first observational, multicenter trial of the Elipse IGB.

    Article  PubMed  Google Scholar 

  14. 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. https://doi.org/10.1007/s11695-017-2877-1.

    Article  CAS  PubMed  Google Scholar 

  15. 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. https://doi.org/10.1016/j.soard.2017.12.001.

    Article  PubMed  Google Scholar 

  16. Raftopoulos I, Giannakou A. The Elipse Balloon, a swallowable gastric balloon for weight loss not requiring sedation, anesthesia or endoscopy: a pilot study with 12-month outcomes. Surg Obes Relat Dis. 2017;13(7):1174–82. https://doi.org/10.1016/j.soard.2017.02.016.

    Article  PubMed  Google Scholar 

  17. Usuy E, Brooks J. Response rates with the Spatz3 adjustable balloon. Obes Surg. 2018;28(5):1271–6. https://doi.org/10.1007/s11695-017-2994-x.

    Article  PubMed  Google Scholar 

  18. Gomez 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 (Silver Spring). 2016;24(9):1849–53. https://doi.org/10.1002/oby.21555.

    Article  Google Scholar 

  19. Apollo Endosurgery. News about ReShape ready. 2018. https://www.orbera.com/reshape/. Accessed 26 Dec 2018.

  20. Force ABET, Committee AT, Abu Dayyeh BK, Kumar N, Edmundowicz SA, Jonnalagadda 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. https://doi.org/10.1016/j.gie.2015.03.1964.

    Article  Google Scholar 

  21. Abu Dayyeh BK, Eaton LL, Woodman G, Fusco M, Shayani F, 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):AB147.

    Article  Google Scholar 

  22. Ashrafian H, Monnich M, Braby TS, Smellie J, Bonanomi G, Efthimiou E. Intragastric balloon outcomes in super-obesity: a 16-year city center hospital series. Surg Obes Relat Dis. 2018;14(11):1691–9. https://doi.org/10.1016/j.soard.2018.07.010.

    Article  PubMed  Google Scholar 

  23. US Food and Drug Administration. Summary of safety and effectiveness data (SSED) Obalon Balloon System. 2016. https://www.accessdata.fda.gov/cdrh_docs/pdf16/P160001b.pdf. Accessed 2 Jan 2019.

  24. Mion F, Ibrahim M, Marjoux S, Ponchon T, Dugardeyn S, Roman S, et al. Swallowable Obalon(R) gastric balloons as an aid for weight loss: a pilot feasibility study. Obes Surg. 2013;23(5):730–3. https://doi.org/10.1007/s11695-013-0927-x.

    Article  PubMed  Google Scholar 

  25. US Food and Drug Administration. Premarket approval (PMA): Obalon touch inflation system. 2018. https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpma/pma.cfm?id=P160001S007. Accessed 3 Jan 2019.

    Google Scholar 

  26. US Food and Drug Administration. Premarket approval (PMA): Obalon balloon system with navigation touch. 2018. https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpma/pma.cfm?id=P160001S020. Accessed 3 Jan 2019.

    Google Scholar 

  27. 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. https://doi.org/10.1055/s-0042-120413.

    Article  PubMed  PubMed Central  Google Scholar 

  28. Machytka E, Chuttani R, Bojkova M, Kupka T, Buzga M, Stecco K, et al. Elipse, a procedureless gastric balloon for weight loss: a proof-of-concept pilot study. Obes Surg. 2016;26(3):512–6. https://doi.org/10.1007/s11695-015-1783-7.

    Article  PubMed  Google Scholar 

  29. Brooks J, Srivastava ED, Mathus-Vliegen EM. One-year adjustable intragastric balloons: results in 73 consecutive patients in the U.K. Obes Surg. 2014;24(5):813–9. https://doi.org/10.1007/s11695-014-1176-3.

    Article  CAS  PubMed  Google Scholar 

  30. Machytka E, Klvana P, Kornbluth A, Peikin S, Mathus-Vliegen LE, Gostout C, et al. Adjustable intragastric balloons: a 12-month pilot trial in endoscopic weight loss management. Obes Surg. 2011;21(10):1499–507. https://doi.org/10.1007/s11695-011-0424-z.

    Article  PubMed  PubMed Central  Google Scholar 

  31. Trang J, Lee SS, Miller A, Cruz Pico CX, Postoev A, Ibikunle I, et al. Incidence of nausea and vomiting after intragastric balloon placement in bariatric patients - a systematic review and meta-analysis. Int J Surg. 2018;57:22–9. https://doi.org/10.1016/j.ijsu.2018.06.038.

    Article  PubMed  Google Scholar 

  32. Maisel W. The FDA alerts health care providers about potential risks with liquid-filled intragastric balloons. 2017. https://www.fda.gov/MedicalDevices/Safety/LetterstoHealthCareProviders/ucm540655.htm. Accessed 16 Feb 2019.

  33. US Food and Drug Administration. Update: potential risks with liquid-filled intragastric balloons -- letter to health care providers. 2017. https://www.fda.gov/MedicalDevices/Safety/LetterstoHealthCareProviders/ucm570707.htm. Accessed 16 Feb 2019.

  34. US Food and Drug Administration. Update: potential risks with liquid-filled intragastric balloons - letter to health care providers. 2018. https://www.fda.gov/MedicalDevices/Safety/LetterstoHealthCareProviders/ucm609597.htm. Accessed 16 Feb 2019.

  35. US Food and Drug Administration. MAUDE - manufacturer and user facility device experience. 2019. https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/search.cfm. Accessed 10 Mar 2019.

    Google Scholar 

  36. Abu Dayyeh BK, Rajan E, Gostout CJ. Endoscopic sleeve gastroplasty: a potential endoscopic alternative to surgical sleeve gastrectomy for treatment of obesity. Gastrointest Endosc. 2013;78(3):530–5. https://doi.org/10.1016/j.gie.2013.04.197.

    Article  PubMed  Google Scholar 

  37. Kumar N, Abu Dayyeh BK, Lopez-Nava Breviere G, Galvao Neto MP, Sahdala NP, Shaikh SN, et al. Endoscopic sutured gastroplasty: procedure evolution from first-in-man cases through current technique. Surg Endosc. 2018;32(4):2159–64. https://doi.org/10.1007/s00464-017-5869-2.

    Article  PubMed  Google Scholar 

  38. Abu Dayyeh BK, Acosta A, Camilleri M, Mundi MS, Rajan E, Topazian MD, et al. Endoscopic sleeve gastroplasty alters gastric physiology and induces loss of body weight in obese individuals. Clin Gastroenterol Hepatol. 2017;15(1):37–43 e1. https://doi.org/10.1016/j.cgh.2015.12.030.

    Article  PubMed  Google Scholar 

  39. Sharaiha RZ, Kumta NA, Saumoy M, Desai AP, Sarkisian AM, Benevenuto A, et al. Endoscopic sleeve gastroplasty significantly reduces body mass index and metabolic complications in obese patients. Clin Gastroenterol Hepatol. 2017;15(4):504–10. https://doi.org/10.1016/j.cgh.2016.12.012.

    Article  PubMed  Google Scholar 

  40. • Lopez-Nava G, Sharaiha RZ, Vargas EJ, Bazerbachi F, Manoel GN, Bautista-Castano I, et al. Endoscopic sleeve gastroplasty for obesity: a multicenter study of 248 patients with 24 months follow-up. Obes Surg. 2017;27(10):2649–55. https://doi.org/10.1007/s11695-017-2693-7 This study demonstrated that 6-month weight loss is a significant predictor of long-term weight loss in ESG.

    Article  PubMed  Google Scholar 

  41. Sartoretto A, Sui Z, Hill C, Dunlap M, Rivera AR, Khashab MA, et al. Endoscopic sleeve gastroplasty (ESG) is a reproducible and effective endoscopic bariatric therapy suitable for widespread clinical adoption: a large, international multicenter study. Obes Surg. 2018;28(7):1812–21. https://doi.org/10.1007/s11695-018-3135-x.

    Article  PubMed  Google Scholar 

  42. • Alqahtani A, Al-Darwish A, Mahmoud AE, Alqahtani YA, Elahmedi M. Short-term outcomes of endoscopic sleeve gastroplasty in 1000 consecutive patients. Gastrointest Endosc. 2018. https://doi.org/10.1016/j.gie.2018.12.012 This prospective, single-center study is the largest study to-date evaluating patients undergoing ESG.

    Article  PubMed  Google Scholar 

  43. Sullivan S, Edmundowicz SA, Thompson CC. Endoscopic bariatric and metabolic therapies: new and emerging technologies. Gastroenterology. 2017;152(7):1791–801. https://doi.org/10.1053/j.gastro.2017.01.044.

    Article  PubMed  Google Scholar 

  44. Espinos JC, Turro R, Moragas G, Bronstone A, Buchwald JN, Mearin F, et al. Gastrointestinal physiological changes and their relationship to weight loss following the POSE procedure. Obes Surg. 2016;26(5):1081–9. https://doi.org/10.1007/s11695-015-1863-8.

    Article  CAS  PubMed  Google Scholar 

  45. Espinos JC, Turro R, Mata A, Cruz M, da Costa M, Villa V, et al. Early experience with the incisionless operating platform (IOP) for the treatment of obesity : the primary obesity surgery endolumenal (POSE) procedure. Obes Surg. 2013;23(9):1375–83. https://doi.org/10.1007/s11695-013-0937-8.

    Article  CAS  PubMed  Google Scholar 

  46. •• Sullivan S, Swain JM, Woodman G, Antonetti M, De L, Cruz-Munoz N, et al. Randomized sham-controlled trial evaluating efficacy and safety of endoscopic gastric plication for primary obesity: the ESSENTIAL trial. Obesity (Silver Spring). 2017;25(2):294–301. https://doi.org/10.1002/oby.21702 This is the first multicenter, randomized sham-controlled trial evaluating POSE.

    Article  Google Scholar 

  47. Miller K, Turro R, Greve JW, Bakker CM, Buchwald JN, Espinos JC. MILEPOST multicenter randomized controlled trial: 12-month weight loss and satiety outcomes after pose (SM) vs. medical therapy. Obes Surg. 2017;27(2):310–22. https://doi.org/10.1007/s11695-016-2295-9.

    Article  PubMed  Google Scholar 

  48. Lopez-Nava G, Bautista-Castano I, Jimenez A, de Grado T, Fernandez-Corbelle JP. The Primary Obesity Surgery Endolumenal (POSE) procedure: one-year patient weight loss and safety outcomes. Surg Obes Relat Dis. 2015;11(4):861–5. https://doi.org/10.1016/j.soard.2014.09.026.

    Article  PubMed  Google Scholar 

  49. US Food and Drug Administration. Summary of safety and effectiveness data (SSED) AspireAssist. 2016. https://www.accessdata.fda.gov/cdrh_docs/pdf15/p150024b.pdf. Accessedd 16 Feb 2019.

  50. Nystrom M, Machytka E, Noren E, Testoni PA, Janssen I, Turro 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(7):1860–8. https://doi.org/10.1007/s11695-017-3096-5.

    Article  PubMed  PubMed Central  Google Scholar 

  51. 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 e1-5. https://doi.org/10.1053/j.gastro.2013.08.056.

    Article  PubMed  Google Scholar 

  52. US Department of Health and Human Services. Health, United States, 2017 With special feature on mortality. 2017. https://www.cdc.gov/nchs/data/hus/hus17.pdf#053. Accessed 4 Jan 2019.

  53. Organisation for Economic Co-operation and Development. Obesity update 2017. 2017. https://www.oecd.org/els/health-systems/Obesity-Update-2017.pdf. Accessed 4 Jan 2019.

  54. Cawley J, Meyerhoefer C. The medical care costs of obesity: an instrumental variables approach. J Health Econ. 2012;31(1):219–30. https://doi.org/10.1016/j.jhealeco.2011.10.003.

    Article  PubMed  Google Scholar 

  55. Dumon KR, Murayama KM. Bariatric surgery outcomes. Surg Clin North Am. 2011;91(6):1313–38, x. https://doi.org/10.1016/j.suc.2011.08.014.

    Article  PubMed  Google Scholar 

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  1. Division of Gastroenterology and Hepatology, University of Colorado School of Medicine, University of Colorado Anschutz Medical Campus, 12631 E 17th Ave, MSB-158, Aurora, CO, 80045, USA

    Joshua A. Turkeltaub MD & Steven A. Edmundowicz MD

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Correspondence to Joshua A. Turkeltaub MD or Steven A. Edmundowicz MD.

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Conflict of Interest

Steven Edmundowicz serves on the medical advisory board for Olympus, is a paid consultant for Elsevier, Medtronic, and Allurion, and receives research support from Medtronic, Spironetics, and Elira. Joshua Turkeltaub declares no conflict of interest.

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Turkeltaub, J.A., Edmundowicz, S.A. Endoscopic Bariatric Therapies: Intragastric Balloons, Tissue Apposition, and Aspiration Therapy. Curr Treat Options Gastro 17, 187–201 (2019). https://doi.org/10.1007/s11938-019-00232-7

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