Adjustable Balloons for Weight Loss: A Higher Yield of Responders Compared With Non-Adjustable Balloons
Adjustable Balloons for Weight Loss: A Higher Yield of Responders Compared With Non-Adjustable Balloons
Intragastric balloon degree of efficacy and duration of effect can be variable and
 unpredictable. The Spatz Adjustable intragastric balloon (AIGB) was developed to extend
 implantation to 1 year, decrease balloon volume for intolerance and increase volume for
 diminishing effect. The aim of the study was to determine the utility/efficacy and responder
 rate with the Spatz3 AIGB.
The results of the Spatz adjustable balloon system have been reported in four studies with
 weight losses of 24.4 kg (48.8% excess weight loss - EWL), 21.6 kg (45.7% EWL),17.2 kg (42.9%
 EWL) and 16.3 kg (67.4% EWL), respectively. The responder rate (>25% EWL) was 88.5% in one
 recent study.

 The authors report and analyze the results of 227 Spatz3 patients retrospectively reviewed in
 3 centers- some adjusted and some not adjusted during the course of their 1-year implantation
 - to determine if the adjustment option can improve overall results and diminish the
 non-responder rate.

 The Spatz3 Adjustable intragastric balloon (IGB) (Spatz FGIA, Inc. New York, USA) was
 implanted at the following centers between May and December 2015: University Hospital,
 Ostrava, Czech Republic, Clinica Opcion Medica, Barcelona, Spain, and Optimal Clinic, Tel
 Aviv, Israel. Patients were selected according to the well-established criteria for
 intragastric balloon implantation, consistent with NIH and CE Mark guidelines, and were
 independently evaluated by members of the staff: gastroenterologists, dieticians, and
 psychologists. Indications for Spatz3 Adjustable IGB implantation included one of the
 following: (1) temporary weight loss treatment in a patient with body mass index (BMI) in the
 range of bariatric surgery (>35) who refuse surgery or are at high risk for surgery, (2)
 temporary weight loss treatment for a patient without indications for surgery (BMI>29). All
 patients underwent upper gastrointestinal endoscopy using conscious sedation with or without
 an anesthetist using one or more of the following medications - Propofol, Midazolam, and
 Fentanyl.

 Balloons were inflated with a mean 464ml (400-500ml) of normal saline with the addition of
 2-3 ml of a 1% solution of Methylene Blue (not used in the Czech Republic center). Patients
 were recovered for 45 minutes and discharged the same day on a once-daily PPI, anti-nausea
 medications (Aprepitant 125 mg day 1; 80 mg days 2 and 3), ondansetron (8 mg Q6H X 3 days),
 anti-spasmodic (papaverine 80 mg tid prn), and dietary instructions. After the fifth
 post-procedure day, a progressive full liquid to soft to solid 1,200-1,400 kcal diet was
 started. Monthly follow up with dietician and/or doctor (gastroenterologist or
 endocrinologist) was offered to all patients after implantation. Cognitive behavioral therapy
 by licensed psychologists was offered in 2 of the 3 centers (206/227 patients) with 6-10
 sessions after implantation. Patients who were intolerant to the balloon could be adjusted
 downward by 100-150 ml. Patients with one or more of the following were offered upward
 adjustments of the balloon volume (200-400 ml at the discretion of the endoscopist): weight
 loss plateau; lack of balloon effect; ability to overeat without resultant symptoms (any of
 the following: nausea, vomiting, bloating, eructation, abdominal pain, acid reflux symptoms).
 Preparation for an adjustment or extraction procedure required the following diet: 3 days
 prior- no meat or vegetables; 2 days prior- full liquids; 1 day prior- clear liquids and NPO
 after midnight. After 12 months of placement, the balloon was deflated by aspiration via
 standard balloon needle or deflation utilizing the valve, and extraction was completed using
 a grasping forceps or a polypectomy snare - all under conscious sedation.
Inclusion Criteria:

 -  temporary weight loss treatment in a patient with body mass index (BMI) in the range
 of bariatric surgery (>35) who refuse surgery or are at high risk for surgery

 -  temporary weight loss treatment for a patient without indications for surgery (BMI >
 29)

 Exclusion Criteria:

 - none