INTRODUCTION
The obesity treatment with intragastric balloon (IGB) has already been established as a safe and effective method.[1-3]The volume of the conventional IGB is set at the time of the placement but after that, changes in the volume cannot be done anymore. The balloon can stay in the stomach for a maximum period of 180 days and must be, imperatively removed until this deadline.[4,5] The Spatz3® ®liquid adjustable balloon was approved in May 2010 in all 27 countries of the European Union for patients with body mass index (BMI) more than 27 kg/m² that failed previous attempts at weight loss. In November 2014, the Spatz3® balloon was approved for clinical use in Brazil. Today Spatz3® ® IGB is in its third generation, is a safer device and easier to use compared to earlier generations.[6]
According to the Tarpon Springs conference held in 1987 in Florida[7], it was defined as being ideal for the IGB the following criteria:1) Have variable filling volume capacity (400-700mL); 2) Be fluid filled (water or saline); 3) Have a radiopaque marker for control of follow-up; 4) Be made from tough and durable material, preventing leakage and 5) Have smooth surface. According to these criteria, the Spatz3® IGB, when compared to conventional one, is better according to the first criterion, since its volume can be controlled throughout the treatment, and not only at the implatation. [8] However, it is worse according to the last issue, since it does not have a completely smooth surface, because it has a ”tail”, the site of filling valve insertion.[8]
The two main differentials of Spatz3® IGB are post implantation volume control and a maximum treatment period of 360 days.[2,7,8] Regarding the volume, it is feasible to adjust the balloon - upward or downward – during all the treatment. The balloon may have its volume reduced in cases of intolerance (excessive and/or persistent vomiting for more than seven days). Withdraws from 100 to 300 mL of the IGB volume, improves the symptoms and allow the patient to continue the treatment. The balloon also may have its volume increased during the treatment, in a predetermined date, or when the patient reports a decrease in satiety. The upward setting in balloon volume may increases the effect of the balloon on weight loss due to increased satiety and greater restriction of food intake.[8] The maximum stay of 360 days results in a sustained weight loss for one year and a longer period of treatment provides more time for the patient to perform alimentary reeducation with the balloon support.[9]
Although adjustable IGB seems to have several potential benefits compared to conventional balloons (better patient tolerability, gradual effective weight loss and longer duration of implantation)[23], to date, few studies (some with a small number of participants) evaluated its safety and efficacy.[2,8,14,27] Moreover, there are some reports questioning its long-term safety.[24-26]
The aim of this study was to analyze the results regarding weight loss and complications with Spatz3® adjustable IGB in a private center in Brazil.