Real-World Safety and Efficacy of Fluid-Filled Dual Intragastric Balloon for Weight Loss

Abhishek Agnihotri, Amy Xie, Christopher Bartalos, Vladimir Kushnir, Sameer Islam, Ebtesam Islam, Mark Lamet, Ari Lamet, Ramin Farboudmanesch, Bergein F. Overholt, Johnny Altawil, Dayna S. Early, Michael Bennett, Abigail Lowe, Daniel K. Mullady, Christine Sade Adeyeri, Mohamad El Zein, Priya Mishra, Lea Fayad, Margo DunlapAndreas Oberbach, Lawrence J. Cheskin, Anthony N. Kalloo, Mouen A. Khashab, Vivek Kumbhari

Research output: Contribution to journalArticlepeer-review

11 Scopus citations

Abstract

Background & Aims: Reshape Duo is a saline-filled dual, integrated intragastric balloon (IGB) approved by the Food and Drug Administration for weight loss in patients with obesity. In a prospective, randomized trial, obese patients who received the balloon had significantly greater percent excess weight loss (%EWL) compared with patients treated with diet and exercise alone. However, there are limited data on the real-world efficacy of the Reshape balloon. Methods: We performed a retrospective study of data collected from 2 academic centers and 5 private practices in which all patients paid for the IGB and follow-up visits out of pocket. The IGB was removed after 6 months. We collected data (demographic, medical, and laboratory) from 202 adults (mean age 47.8 ± 10.8 years; 83% female) with a baseline mean body mass index of 36.8 + 8.4 kg/m2 who had IGB insertion for weight loss therapy, along with counselling on lifestyle modifications focused on diet and exercise. Primary outcomes were percent total body weight loss (%TBWL) and %EWL at 1, 3, 6, 9, and 12 months after the procedure. Results: Mean %TBWL at 1, 3, 6, 9 and 12 months was 4.8 ± 2.4%, 8.8 ± 4.3%, 11.4 ± 6.7%, 13.3 ± 7.8%, and 14.7 ± 11.8%, respectively. Data were available from 101 patients at 6 months and 12 patients at 12 months; 60.4% of patients achieved more than 10% TBWL and 55.4% had more than 25% EWL. Seventeen patients (8.4%) had esophageal tears during balloon insertion, with no intervention required. Thirteen patients (6.4%) had their IGB removed before the end of the 6-month treatment period. Nausea, vomiting, and abdominal pain were the most common adverse effects, occurring in 149 (73.8%), 99 (49%), and 51 (25.2%) patients. In one patient, the IGB migrated distally leading to small intestinal obstruction requiring surgical removal. Conclusion: In a retrospective analysis of real-world patients who received the Reshape Duo IGB, we found it to be a safe and efficacious endoscopic method for producing weight loss, with most patients achieving greater than 10% TBWL at 6 months.

Original languageEnglish
Pages (from-to)1081-1088.e1
JournalClinical Gastroenterology and Hepatology
Volume16
Issue number7
DOIs
StatePublished - Jul 2018

Keywords

  • BMI
  • Endoscopy
  • Food Intake
  • Overweight
  • Satiety

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