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Response Rates with the Spatz3 Adjustable Balloon

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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%.

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Authors and Affiliations

  1. Usuy Clinic, Florianópolis, Brazil

    Eduardo Usuy

  2. Optimal Clinic, Tel Aviv, Israel

    Jeffrey Brooks

Authors
  1. Eduardo Usuy
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  2. Jeffrey Brooks
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Corresponding author

Correspondence to Eduardo Usuy.

Ethics declarations

All procedures performed in studies involving human participants were in accordance with the ethical standards of the institutional and/or national research committee and with the 1964 Helsinki declaration and its later amendments or comparable ethical standards. This article does not contain any studies with animals performed by any of the authors.

Conflict of Interest

Dr. Eduardo Usuy Jr. has no conflict of interest to report. Dr. Jeffrey Brooks is a shareholder in Spatz FGIA, Inc.

Informed Consent

Informed consent was obtained from all individual participants included in the study.

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Usuy, E., Brooks, J. Response Rates with the Spatz3 Adjustable Balloon. OBES SURG 28, 1271–1276 (2018). https://doi.org/10.1007/s11695-017-2994-x

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