Response Rates with the Spatz3 Adjustable Balloon

Abstract

Background: 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 1 year, decreases balloon volume for intolerance, and increases volume for diminishing effect.

Aim: The aim of this study is to determine the efficacy/responder rate of the Spatz3 AIGB.

Methods: Implantations of Spatz3 in 165 consecutive patients (pts) in 2 centers were retrospectively reviewed. Mean BMI is 35.7, mean weight (wt) 99.1 kg, and mean balloon volume 495 ml (400-600 ml). Balloon volume adjustments were offered for intolerance and for wt loss plateau.

Results: In total, 165 pts were implanted yielding mean wt loss of 16.3 kg, 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 - 150 ml) allowed 16/20 (80%) to continue IGB therapy. Up adjustments in 64 patients (mean 5.4 months; mean + 260 ml) yielded additional mean wt loss of 5.7 kg. One gastric perforation (0.6%) occurred in a patient who experienced abdominal pain for 2 weeks. Five patients with small ulcers did not require balloon extraction.

Conclusions: (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 5.7 kg 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%.

Keywords: Adjustable gastric balloon; Intolerance; Intragastric balloons; Obesity; Responder; Wt loss; Wt loss plateau.