Abstract
Intragastric balloons (IGBs) have demonstrated efficacy; however, the percent of "responders" (>25% estimated weight loss (EWL) or >10% total body weight loss (TBWL)-as suggested by FDA) have been less reported. The Spatz3 adjustable intragastric balloon (AIGB) extends implantation to 1year, decreases balloon volume for intolerance, and increases volume for diminishing effect. The aim of this study is to determine the efficacy/responder rate of the Spatz3 AIGB. Implantations of Spatz3 in 165 consecutive patients (pts) in 2 centers were retrospectively reviewed. Mean BMI is 35.7, mean weight (wt) 99.1kg, and mean balloon volume 495ml (400-600ml). Balloon volume adjustments were offered for intolerance and for wt loss plateau. In total, 165 pts were implanted yielding mean wt loss of 16.3kg, 16.4% TBWL, and 67.4% EWL. Response (>25% EWL; 10% TBWL) was achieved in 146/165 (88.5%) of patients. Response rates differed for 136 pts with BMI <40 (91.2%) and 29 pts with BMI >40 (69%). Down adjustments in 20 patients (mean -150ml) allowed 16/20 (80%) to continue IGB therapy. Up adjustments in 64 patients (mean 5.4months; mean +260ml) yielded additional mean wt loss of 5.7kg. One gastric perforation (0.6%) occurred in a patient who experienced abdominal pain for 2weeks. Five patients with small ulcers did not require balloon extraction. (1) Within the limitations of a retrospective review, the Spatz3 balloon appears to be an effective wt loss balloon with better response rates in BMI <40. (2) Up adjustments yielded a mean 5.7kg extra wt loss. (3) Down adjustments alleviated early intolerance in 80% of patients. (4) These two adjustment functions may be instrumental in yielding a responder rate of 88.5%.
Published Version
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