One year adjustable intragastric balloon: safety and efficacy of the Spatz3 adjustable balloons

Abstract

Discuss this article AbstractThe Spatz3 Adjustable balloon system is approved for 1 year Background: implantation and allows multiple changes in the balloon volume during the course of implantation. Other intragastric balloons are currently approved for 6 months and their balloon volumes cannot be adjusted after implantation.To determine the efficacy and safety of the Spatz3 adjustable balloon Aim: system.Seventy seven consecutive patients (66 females and 11 males) in Methods: two medical centers were implanted with the Spatz3 adjustable balloon device and were followed prospectively. The patients' mean BMI was 37.2; the mean weight was 108.7 kg; the mean age was 41 (16-68); the mean balloon volume was 469 ml (450-500 ml). Adjustments were made for intolerance or weight loss plateau.The mean weight loss at 1 year was 17.2 kg with 15.9 % weight loss Results: and 42.9 % Excess Weight Loss (%EWL). Eighteen patients underwent balloon volume adjustments: three downward adjustments of 100 -150 cc which alleviated early intolerance; 15 upward adjustments (mean 320 ml; range 200-500) at a mean 4.1 months (range 2-5 months) yielded additional mean wt loss of 8.2 kg (range 0-25 kg) after the adjustment. Three balloons were removed before the 1 year completion date due to intolerance and three others were removed for other reasons (pregnancy, gall bladder surgery, and alcoholism). There was one episode of gastric ulceration which required endoscopic therapy and balloon removal. There were no deflations or perforations.The Spatz3 adjustable balloon is a safe and effective treatment Conclusions: for weight loss. The adjustability function can yield greater weight loss for those who show weight loss plateau and can mitigate intolerance.

Randomized Prospective Clinical Study On The Spatz3® Adjustable Intragastric Balloon Treatment With a Control Group: A Large Brazilian Experience

“…Only two removals (1.11%) were performed due to severe symptoms (excessive vomiting) in patients who did not wish to do the downward adjustment and decided to quit the treatment. The incidence of early removal in the present study was 7.77%, being similar to that observed in other studies conducted with Spatz, Machytka et al (2014) [6] observed 7.79% and Brooks et al (2014) [14] 5.47%. However, this rate is higher than the observed in studies conducted with conventional IGB, Genco et al (2005) [9] observed 0.44%, Lopez-Nava et al (2011) [12] 0.8% and Sallet et al (2004) [1] 3.4% .…”

“…Furthermore, patients who underwent downward adjustment (n = 8; 4.44%), all, without exception, completed the minimum 9 months treatment, similar to what was observed in other Spatz (r) IGB studies. [6,14] Thus, it seems that the downward balloon adjustment may contribute to a better adaptation and a lower early removal rate.…”

“…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.…”

Spatz3 Adjustable Balloon: Weight Loss and Response Rates in Brazil

“…Our experience alleviating intolerance and preventing early extraction with balloon volume down adjustments is consistent with previously published Spatz3 studies [22][23][24][25]. Similarly, our use of upward adjustments (for decreased balloon effect) which added a mean 6.5kg extra weight loss is consistent with previously published Spatz3 data, which reported additional weight loss after upward adjustments of 8.2 kg, 8.9 kg, 5 kg and 5.7 kg [22][23][24][25]. These balloon volume manipulations have produced an impressive percentage of patients that have a successful outcome-79% (297/376) had > 25% EWL in our retrospective series.…”

“…Studies have reported the results of the Spatz adjustable balloon system with wt losses of 24.4 kg (48.8% EWL), 21.6 kg (45.7% EWL), 17.2 kg (42.9% EWL), and 16.3 kg (67.4% EWL), respectively [20][21][22][23]. It is possible that alleviating intolerance with a downward adjustment and renewing wt loss after balloon upward adjustment may be able to improve weight loss results.…”