The Influence of the Orbera Intragastric Balloon Filling Volumes on Weight Loss, Tolerability, and Adverse Events: a Systematic Review and Meta-Analysis

• Published in: Obesity surgery Vol. 27; no. 9; pp. 2272 - 2278
• Main Authors: Kumar, Nitin, Bazerbachi, Fateh, Rustagi, Tarun, McCarty, Thomas R., Thompson, Christopher C., Galvao Neto, Manoel P., Zundel, Natan, Wilson, Erik B., Gostout, Christopher J., Abu Dayyeh, Barham K.
• Format: Journal Article
• Language: English
• Published: New York Springer US 01-09-2017; Springer Nature B.V
• Subjects: Bariatric Surgery - adverse effects; Bariatric Surgery - statistics & numerical data; Body Mass Index; Female; Gastric Balloon - adverse effects; Gastric Balloon - statistics & numerical data; Gastrointestinal surgery; Humans; Intubation, Gastrointestinal - adverse effects; Intubation, Gastrointestinal - statistics & numerical data; Male; Medicine; Medicine & Public Health; Meta-analysis; Obesity; Obesity, Morbid - epidemiology; Obesity, Morbid - surgery; Original Contributions; Postoperative Complications - epidemiology; Postoperative Complications - etiology; Prosthesis Failure - adverse effects; Prosthesis Failure - etiology; Surgery; Surgical outcomes; Weight control; Weight Loss; Obesity; Endoscopic bariatric; Weight management
• ISSN: 0960-8923; 1708-0428
• DOI: 10.1007/s11695-017-2636-3

Background
The Orbera intragastric balloon (IGB) has been approved by the US Food and Drug Administration for use in patients with a body mass index (BMI) between 30 and 40 kg/m
2
and is in wide use worldwide as a primary and bridge obesity management tool. The balloon filling volume (BFV) ranges between 400 and 700 mL of saline. Our objective was to determine whether there is an association between BFV and clinically relevant endpoints, namely weight loss outcomes, balloon tolerability, and adverse events.
Methods
A systematic review of studies investigating the use of the Orbera IGB system for obesity treatment was performed. Data was examined using random effects modelling and meta-regression analyses.
Results
Forty-four studies (
n
 = 5549 patients) reported BFV and % total body weight loss (TBWL) at 6 months. Pooled %TBWL at 6 months was 13.2% [95% CI 12.3–14.0]. A funnel plot demonstrated a low risk of publication bias. Meta-regression showed no statistically significant association between filling volume and %TBWL at 6 months (
p
 = 0.268). Higher BFV was associated with lower rates of esophagitis (slope = −0.008,
p
 < 0.001) and prosthesis migration (slope = −0.015,
p
 < 0.001). There was no association between BFV and early removal (
p
 = 0.1), gastroesophageal reflux symptom (
p
 = 0.64), or ulcer rates (
p
 = 0.09).
Conclusions
No association was observed between Orbera IGB filling volume and weight loss outcomes. Higher volumes appear to be associated with lower migration and esophagitis rates; thus, a balloon filling volume of 600–650 mL is recommended.