Abstract
Background: The degree of efficacy and duration of effect of Intragastric Balloons (IGBs) can be variable and unpredictable. The Spatz Adjustable Intragastric Balloon (AIGB) was developed to address these issues by extending implantation to 1 year, decreasing balloon volume for intolerance and increasing volume for decreased balloon effect.Aims: To determine the efficacy and response rate of the Spatz3 AIGB.Methods: Results of 379 consecutive patients (pts) implanted with the Spatz3 AIGB were retrospectively reviewed (3 lost to follow up). Mean BMI 35.5; mean weight (wt) 97.5 kg; mean excess wt 29.1 kg; mean balloon volume 600ml. Balloon volume adjustments were offered: Down adjustments for intolerance and up adjustments for decreased balloon effect.Results: The mean implantation time of 376 pts was 10.6 months yielding mean wt loss 14.9 kg; mean 15.1% Total Body Wt Loss (%TBL) and 58% Excess Wt Loss(%EWL). Response rate (> 25%EWL) was achieved in 79% (297/376) of pts. Down adjustments in 95 pts (mean 2.4 months; mean -152.4 ml) allowed 76/95 (80%) to continue IGB therapy for at least 6 months (mean 9.1 months). Up adjustments in 205/376 (54.5%) pts (mean 5.8 months; mean + 179.2 ml) yielded additional mean wt loss of 6.5 kg. There was 1 gastric ulcer (0.27%). One balloon deflated at 7.4 months and 4 others deflated after 1 year (13-23 months).Conclusions: In this retrospective review of 376 Spatz3 AIGB patients, up adjustments yielded a mean 6.5kg extra wt loss for those with wt loss plateau, and down adjustments alleviated early intolerance. These two adjustment functions may be instrumental in yielding a successful outcome (> 25% EWL) in 79% of pts.
Highlights
Intragastric balloons (IGBs) have been successfully used for wt loss for the last 30 years
Intolerance, with nausea vomiting or pain requiring early balloon extraction has been documented in the literature and ranges from 3-7% [1,2] – this was recently confirmed in the FDA trials for Reshape Duo and Orbera Intragastric Balloons (IGBs) where there was a reported 14% and 22% early extraction rate, respectively [17,18]
Wt loss results and response rates are displayed in table 2 and table 3
Summary
Intragastric balloons (IGBs) have been successfully used for wt loss for the last 30 years. The adjustability function was developed to improve patient response by decreasing balloon size for intolerance and increasing balloon size when balloon effect wears off. The Spatz Adjustable Intragastric Balloon (AIGB) was developed to address these issues by extending implantation to 1 year, decreasing balloon volume for intolerance and increasing volume for decreased balloon effect. Conclusions: In this retrospective review of 376 Spatz[3] AIGB patients, up adjustments yielded a mean 6.5kg extra wt loss for those with wt loss plateau, and down adjustments alleviated early intolerance. These two adjustment functions may be instrumental in yielding a successful outcome (> 25% EWL) in 79% of pts
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