TY - JOUR
T1 - The Influence of the Orbera Intragastric Balloon Filling Volumes on Weight Loss, Tolerability, and Adverse Events
T2 - a Systematic Review and Meta-Analysis
AU - Kumar, Nitin
AU - Bazerbachi, Fateh
AU - Rustagi, Tarun
AU - McCarty, Thomas R.
AU - Thompson, Christopher C.
AU - Galvao Neto, Manoel P.
AU - Zundel, Natan
AU - Wilson, Erik B.
AU - Gostout, Christopher J.
AU - Abu Dayyeh, Barham K.
N1 - Publisher Copyright:
© 2017, Springer Science+Business Media New York.
PY - 2017/9/1
Y1 - 2017/9/1
N2 - 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/m2 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.
AB - 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/m2 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.
KW - Endoscopic bariatric
KW - Obesity
KW - Weight management
UR - http://www.scopus.com/inward/record.url?scp=85014891241&partnerID=8YFLogxK
UR - http://www.scopus.com/inward/citedby.url?scp=85014891241&partnerID=8YFLogxK
U2 - 10.1007/s11695-017-2636-3
DO - 10.1007/s11695-017-2636-3
M3 - Article
C2 - 28285471
AN - SCOPUS:85014891241
SN - 0960-8923
VL - 27
SP - 2272
EP - 2278
JO - Obesity Surgery
JF - Obesity Surgery
IS - 9
ER -