Safety and Effectiveness of Two Different Fluid-Filled Intragastric Balloons: A Single Center Experience.

Abstract

Objective: The aim of the study is to compare weight loss and safety outcomes of two different commonly available fluid-filled intragastric balloons (IGBs) used for weight loss.

Method: A retrospective cohort study of a prospectively maintained database of adult patients who underwent IGB insertion between July 2020 and November 2021 in a single private clinic in Kuwait. The patient either received the Elipse™ or Orbera365™ balloon and was followed until the end of treatment.

Result: A total of 358 patients were included, of which 265 and 93 each received the Elipse and Orbera365 balloons, respectively. The mean age of patients was 32.8 (SD 9), the mean body mass index (BMI) was 35 kg/m² (SD 4.8), and 72.1% of patients were female. In the Elipse group, 254 patients completed treatment, and 84 patients completed the treatment with Orbera365. Weight loss outcomes were measured at the end of treatment: 4 months after Elipse insertion, and 12 months after Orbera365 insertion. Interim 4 months weight loss outcomes were also measured for the Orbera365 balloon. Patients in the Orbera365 group had significantly better total body weight loss (%TBWL, 14.7 kg [SD 8.9]) compared to the Elipse group (%TBWL 10 kg, [SD 5.6], p ≤ 0.0001) at the end of treatment, while there was no difference in weight loss outcomes between the two balloons at 4 months. There were more complications requiring premature balloon removal in the Orbera365 group (9.7%) compared to the Elipse group (3.4%).

Conclusion: IGBs provide significant weight loss with an acceptable safety profile. The Orbera365 ballon shows better weight loss outcomes compared to the Elipse, likely due to longer duration of treatment. However, there was a higher rate of complications requiring premature balloon removal in the Orbera365 group. Studies with larger patient cohort is needed to verify the findings of this study.