Clin Endosc.  2021 Jan;54(1):9-16. 10.5946/ce.2020.302.

The Clinical and Metabolic Effects of Intragastric Balloon on Morbid Obesity and Its Related Comorbidities

• Cho JH
• Bilal M
• Kim MC
• Cohen J
• The Study Group for Endoscopic Bariatric and Metabolic Therapies of the Korean Society of Gastrointestinal Endoscopy

• KMID: 2512304
• DOI: http://doi.org/10.5946/ce.2020.302

Abstract

Obesity is becoming increasingly prevalent worldwide, and its metabolic sequelae lead to a significant burden on healthcare resources. Options for the management of obesity include lifestyle modification, pharmacological treatment, surgery, and endoscopic bariatric therapies (EBTs). Among these, EBTs are more effective than diet and lifestyle modification and are less invasive than bariatric surgery. In recent years, there have been significant advances in technologies pertaining to EBTs. Of all the available EBTs, there is a significant amount of clinical experience and published data regarding intragastric balloons (IGBs) because of their comparatively long development period. Currently, the United States Food and Drug Administration (FDA) has approved three IGBs, including Orbera (Apollo Endosurgery, Austin, TX, USA), ReShape Duo (ReShape Medical, San Clemente, CA, USA), and Obalon (Obalon Therapeutics, Carlsbad, CA, USA). The aim of this review is to summarize the available literature on the efficacy of IGBs in weight loss and their impact on obesity-related metabolic diseases.

Keyword

Bariatrics; Endoscopy; Intragastric balloon; Metabolic; Obesity

Figure

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  Fig. 1. (A) Orbera (http://apolloendo.com), (B) ReShape Duo [16], (C) Obalon (http://www.obalon.com), (D) Spatz3 [17], (E) Elipse [25], (F) Heliosphere BAG [20], (G) End-ball (http://www.endalis.com).

Reference

1. Kushner RF, Kahan S. Introduction: the state of obesity in 2017. Med Clin North Am. 2018; 102:1–11.

2. Segula D. Complications of obesity in adults: a short review of the literature. Malawi Med J. 2014; 26:20–24.

3. Aune D, Sen A, Prasad M, et al. BMI and all cause mortality: systematic review and non-linear dose-response meta-analysis of 230 cohort studies with 3.74 million deaths among 30.3 million participants. BMJ. 2016; 353:i2156.

4. Global BMI Mortality Collaboration, Di Angelantonio E, Bhupathiraju Sh N, et al. Body-mass index and all-cause mortality: individual-participant-data meta-analysis of 239 prospective studies in four continents. Lancet. 2016; 388:776–786.

5. Buchwald H, Estok R, Fahrbach K, et al. Weight and type 2 diabetes after bariatric surgery: systematic review and meta-analysis. Am J Med. 2009; 122:248–256.e5.

6. Schauer PR, Kashyap SR, Wolski K, et al. Bariatric surgery versus intensive medical therapy in obese patients with diabetes. N Engl J Med. 2012; 366:1567–1576.

7. Morino M, Toppino M, Forestieri P, Angrisani L, Allaix ME, Scopinaro N. Mortality after bariatric surgery: analysis of 13,871 morbidly obese patients from a national registry. Ann Surg. 2007; 246:1002–1007. discussion 1007-1009.

8. Sullivan S, Edmundowicz SA, Thompson CC. Endoscopic bariatric and metabolic therapies: new and emerging technologies. Gastroenterology. 2017; 152:1791–1801.

9. Geliebter A, Westreich S, Gage D. Gastric distention by balloon and testmeal intake in obese and lean subjects. Am J Clin Nutr. 1988; 48:592–594.

10. Stefater MA, Wilson-Pérez HE, Chambers AP, Sandoval DA, Seeley RJ. All bariatric surgeries are not created equal: insights from mechanistic comparisons. Endocr Rev. 2012; 33:595–622.

11. Nieben OG, Harboe H. Intragastric balloon as an artificial bezoar for treatment of obesity. Lancet. 1982; 1:198–199.

12. Benjamin SB, Maher KA, Cattau EL Jr, et al. Double-blind controlled trial of the Garren-Edwards gastric bubble: an adjunctive treatment for exogenous obesity. Gastroenterology. 1988; 95:581–588.

13. US Food and Drug Administration. Summary of safety and effectiveness data (SSED): ORBERATM Intragastric Balloon System [Internet]. Silver Spring (MD): FDA;c2015. [updated 2015 Aug 5; cited 2019 Jan 2]. Available from: https://www.accessdata.fda.gov/cdrh_docs/pdf14/P140008b.pdf.

14. US Food and Drug Administration. Summary of safety and effectiveness data (SSED): ReShapeTM Integrated Dual Balloon System [Internet]. Silver Spring (MD): FDA;c2015. [updated 2015 Jul 28; cited 2019 Jan 2]. Available from: https://www.accessdata.fda.gov/cdrh_docs/pdf14/P140012b.pdf.

15. US Food and Drug Administration. Summary of safety and effectiveness data (SSED): Obalon Balloon System [Internet]. Silver Spring (MD): FDA;c2016. [updated 2016 Sep 8; cited 2019 Jan 2]. Available from: https://www.accessdata.fda.gov/cdrh_docs/pdf16/P160001b.pdf.

16. ReShapeTM integrated dual balloon system instructions for use [Internet]. St. Paul (MN): EnteroMedics Inc.;c2015. [updated 2015 Dec 15]. Available from: https://www.reshapelifesciences.com/wp-content/uploads/2018/02/ReShape_Balloon_ReShape-vBloc_IFU_1-31-18.pdf.

17. Machytka E, Klvana P, Kornbluth A, et al. Adjustable intragastric balloons: a 12-month pilot trial in endoscopic weight loss management. Obes Surg. 2011; 21:1499–1507.

18. Lopasso FP, Sakai P, Gazi BM, et al. A pilot study to evaluate the safety, tolerance, and efficacy of a novel stationary antral balloon (SAB) for obesity. J Clin Gastroenterol. 2008; 42:48–53.

19. Machytka E, Chuttani R, Bojkova M, et al. Elipse^TM, a procedureless gastric balloon for weight loss: a proof-of-concept pilot study. Obes Surg. 2016; 26:512–516.

20. Trande P, Mussetto A, Mirante VG, et al. 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.

21. Bužga M, Evžen M, Pavel K, et al. Effects of the intragastric balloon MedSil on weight loss, fat tissue, lipid metabolism, and hormones involved in energy balance. Obes Surg. 2014; 24:909–915.

22. Żurawiński W, Sokołowski D, Krupa-Kotara K, Czech E, Sosada K. Evaluation of the results of treatment of morbid obesity by the endoscopic intragastric balloon implantation method. Wideochir Inne Tech Maloinwazyjne. 2017; 12:37–48.

23. Buzga M, Kupka T, Siroky M, et al. Short-term outcomes of the new intragastric balloon End-Ball^® for treatment of obesity. Wideochir Inne Tech Maloinwazyjne. 2016; 11:229–235.

24. Bazerbachi F, Haffar S, Sawas T, et al. Fluid-filled versus gas-filled intragastric balloons as obesity interventions: a network meta-analysis of randomized trials. Obes Surg. 2018; 28:2617–2625.

25. Choi SJ, Choi HS. Various intragastric balloons under clinical investigation. Clin Endosc. 2018; 51:407–415.

26. Trang J, Lee SS, Miller A, et al. Incidence of nausea and vomiting after intragastric balloon placement in bariatric patients - a systematic review and meta-analysis. Int J Surg. 2018; 57:22–29.

27. Brill JV. Reimbursement for endoscopic bariatric therapies. Gastrointest Endosc Clin N Am. 2017; 27:343–351.

28. Doldi SB, Micheletto G, Perrini MN, Librenti MC, Rella S. Treatment of morbid obesity with intragastric balloon in association with diet. Obes Surg. 2002; 12:583–587.

29. ASGE Bariatric Endoscopy Task Force and ASGE Technology Committee, Kumar N, Abu Dayyeh BK, 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; 82:425–438.e5.

30. Yorke E, Switzer NJ, Reso A, et al. Intragastric balloon for management of severe obesity: a systematic review. Obes Surg. 2016; 26:2248–2254.

31. Choudhary NS, Puri R, Saraf N, et al. Intragastric balloon as a novel modality for weight loss in patients with cirrhosis and morbid obesity awaiting liver transplantation. Indian J Gastroenterol. 2016; 35:113–116.

32. Gentileschi P, Venza M, Benavoli D, et al. Intragastric balloon followed by biliopancreatic diversion in a liver transplant recipient: a case report. Obes Surg. 2009; 19:1460–1463.

33. Al-Sabah S, Al-Marri F, Vaz JD. Intragastric balloon as a bridge procedure in patients with high body mass index. Surg Obes Relat Dis. 2016; 12:1900–1901.

34. Coffin B, Maunoury V, Pattou F, et al. Impact of intragastric balloon before laparoscopic gastric bypass on patients with super obesity: a randomized multicenter study. Obes Surg. 2017; 27:902–909.

35. Frutos MD, Morales MD, Luján J, Hernández Q, Valero G, Parrilla P. Intragastric balloon reduces liver volume in super-obese patients, facilitating subsequent laparoscopic gastric bypass. Obes Surg. 2007; 17:150–154.

36. Storm AC, Lakdawala NK, Thompson CC. Intragastric balloon for management of morbid obesity in a candidate for heart transplantation. J Heart Lung Transplant. 2017; 36:820–821.

37. Genco A, Bruni T, Doldi SB, et al. BioEnterics intragastric balloon: the Italian experience with 2,515 patients. Obes Surg. 2005; 15:1161–1164.

38. Imaz I, Martínez-Cervell C, García-Alvarez EE, Sendra-Gutiérrez JM, González-Enríquez J. Safety and effectiveness of the intragastric balloon for obesity. A meta-analysis. Obes Surg. 2008; 18:841–846.

39. Genco A, Cipriano M, Bacci V, et al. BioEnterics Intragastric Balloon (BIB): a short-term, double-blind, randomised, controlled, crossover study on weight reduction in morbidly obese patients. Int J Obes (Lond). 2006; 30:129–133.

40. Konopko-Zubrzycka M, Baniukiewicz A, Wróblewski E, et al. The effect of intragastric balloon on plasma ghrelin, leptin, and adiponectin levels in patients with morbid obesity. J Clin Endocrinol Metab. 2009; 94:1644–1649.

41. Farina MG, Baratta R, Nigro A, et al. Intragastric balloon in association with lifestyle and/or pharmacotherapy in the long-term management of obesity. Obes Surg. 2012; 22:565–571.

42. Lee YM, Low HC, Lim LG, et al. Intragastric balloon significantly improves nonalcoholic fatty liver disease activity score in obese patients with nonalcoholic steatohepatitis: a pilot study. Gastrointest Endosc. 2012; 76:756–760.

43. Fuller NR, Pearson S, Lau NS, et al. An intragastric balloon in the treatment of obese individuals with metabolic syndrome: a randomized controlled study. Obesity (Silver Spring). 2013; 21:1561–1570.

44. Peker Y, Coskun H, Bozkurt S, Cin N, Atak T, Genc H. Comparison of results of laparoscopic gastric banding and consecutive intragastric balloon application at 18 months: a clinical prospective study. J Laparoendosc Adv Surg Tech A. 2011; 21:471–475.

45. Ponce J, Woodman G, Swain J, 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; 11:874–881.

46. Sullivan S, Swain J, Woodman G, et al. Randomized sham-controlled trial of the 6-month swallowable gas-filled intragastric balloon system for weight loss. Surg Obes Relat Dis. 2018; 14:1876–1889.

47. Moura D, Oliveira J, De Moura EG, et al. Effectiveness of intragastric balloon for obesity: a systematic review and meta-analysis based on randomized control trials. Surg Obes Relat Dis. 2016; 12:420–429.

48. Saber AA, Shoar S, Almadani MW, et al. Efficacy of first-time intragastric balloon in weight loss: a systematic review and meta-analysis of randomized controlled trials. Obes Surg. 2017; 27:277–287.

49. Kotinda A, de Moura DTH, Ribeiro IB, et al. Efficacy of intragastric balloons for weight loss in overweight and obese adults: a systematic review and meta-analysis of randomized controlled trials. Obes Surg. 2020; 30:2743–2753.

50. Singh S, de Moura DTH, Khan A, et al. Intragastric balloon versus endoscopic sleeve gastroplasty for the treatment of obesity: a systematic review and meta-analysis. Obes Surg. 2020; 30:3010–3029.

51. Herve J, Wahlen CH, Schaeken A, et al. What becomes of patients one year after the intragastric balloon has been removed? Obes Surg. 2005; 15:864–870.

52. Dastis NS, François E, Deviere J, et al. Intragastric balloon for weight loss: results in 100 individuals followed for at least 2.5 years. Endoscopy. 2009; 41:575–580.

53. Tai CM, Lin HY, Yen YC, et al. Effectiveness of intragastric balloon treatment for obese patients: one-year follow-up after balloon removal. Obes Surg. 2013; 23:2068–2074.

54. Dumonceau JM. Evidence-based review of the Bioenterics intragastric balloon for weight loss. Obes Surg. 2008; 18:1611–1617.

55. Ricci G, Bersani G, Rossi A, Pigò F, De Fabritiis G, Alvisi V. Bariatric therapy with intragastric balloon improves liver dysfunction and insulin resistance in obese patients. Obes Surg. 2008; 18:1438–1442.

56. Folini L, Veronelli A, Benetti A, et al. Liver steatosis (LS) evaluated through chemical-shift magnetic resonance imaging liver enzymes in morbid obesity; effect of weight loss obtained with intragastric balloon gastric banding. Acta Diabetol. 2014; 51:361–368.

57. Mafort TT, Madeira E, Madeira M, et al. Six-month intragastric balloon treatment for obesity improves lung function, body composition, and metabolic syndrome. Obes Surg. 2014; 24:232–240.

58. Busetto L, Enzi G, Inelmen EM, et al. Obstructive sleep apnea syndrome in morbid obesity: effects of intragastric balloon. Chest. 2005; 128:618–623.

59. Fuster JJ, Ouchi N, Gokce N, Walsh K. Obesity-induced changes in adipose tissue microenvironment and their impact on cardiovascular disease. Circ Res. 2016; 118:1786–1807.

60. Martyniak K, Masternak MM. Changes in adipose tissue cellular composition during obesity and aging as a cause of metabolic dysregulation. Exp Gerontol. 2017; 94:59–63.

61. Blüher M. Adipose tissue inflammation: a cause or consequence of obesity-related insulin resistance? Clin Sci (Lond). 2016; 130:1603–1614.

62. Katsiki N, Mantzoros C, Mikhailidis DP. Adiponectin, lipids and atherosclerosis. Curr Opin Lipidol. 2017; 28:347–354.

63. Guedes MR, Fittipaldi-Fernandez RJ, Diestel CF, Klein M. Impact of intragastric balloon treatment on adipokines, cytokines, and metabolic profile in obese individuals. Obes Surg. 2019; 29:2600–2608.

64. Popov VB, Ou A, Schulman AR, Thompson CC. The impact of intragastric balloons on obesity-related co-morbidities: a systematic review and meta-analysis. Am J Gastroenterol. 2017; 112:429–439.

65. Popov VB, Thompson CC, Kumar N, Ciarleglio MM, Deng Y, Laine L. Effect of intragastric balloons on liver enzymes: a systematic review and meta-analysis. Dig Dis Sci. 2016; 61:2477–2487.

66. Mathus-Vliegen EM, Tygat GN. Gastro-oesophageal reflux in obese subjects: influence of overweight, weight loss and chronic gastric balloon distension. Scand J Gastroenterol. 2002; 37:1246–1252.

67. Mathus-Vliegen EM, van Weeren M, van Eerten PV. Los function and obesity: the impact of untreated obesity, weight loss, and chronic gastric balloon distension. Digestion. 2003; 68:161–168.

68. Rossi A, Bersani G, Ricci G, Petrini C, DeFabritiis G, Alvisi V. Intragastric balloon insertion increases the frequency of erosive esophagitis in obese patients. Obes Surg. 2007; 17:1346–1349.

69. Kim WY, Kirkpatrick UJ, Moody AP, Wake PN. Large bowel impaction by the BioEnterics Intragastric Balloon (BIB) necessitating surgical intervention. Ann R Coll Surg Engl. 2000; 82:202–204.

70. Vanden Eynden F, Urbain P. Small intestine gastric balloon impaction treated by laparoscopic surgery. Obes Surg. 2001; 11:646–648.

71. 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; 25:2263–2267.

72. Mathus-Vliegen EM, Alders PR, Chuttani R, Scherpenisse J. Outcomes of intragastric balloon placements in a private practice setting. Endoscopy. 2015; 47:302–307.