First Reports of the New Spatz3 Adjustable Balloon System

FIRST REPORTS OF THE NEW SPATZ 3 ADJUSTABLE BALLOON SYSTEM

Presentation at Canadian DDW Conference, February 2014

Jeffrey Brooks1, Zbigniew Kowalcyk2, Sameer Al Awadhi3, M. Al Falasi3, John Mason4, Laszlo Bene5, Evgen Machytka6, Samer El Asala7, Valenti Puig-Divi8

1. Spatz FGIA, NY, United States. 2. Bariatric Clinic of Lodz, Lodz, Poland.3. Rashid Hospital, Dubai, United Arab Emirates. 4. National Obesity Surgery Center, Manchester, United Kingdom.5. Rozsakert Medical Center, Budapest, Hungary.6. University Hospital of Ostrava, Ostrava, Czech Republic.7. Alain Hospital, Dubai, United Arab Emirates. 8. Opcion Medical Clinic, Barcelona, Spain.

Background: The original Spatz Adjustable Balloon System for weight loss was introduced in 2010. It was the first intragastric balloon approved for 1 year implantation with the added feature of balloon volume adjustability. This enabled changes to balloon volume during the course of the 1 year implantation period. It contained a rigid catheter and metal chain that caused duodenal migration. The new Spatz 3 intragastric balloon device, CE Mark approval in 2012, has a soft catheter to simplify the procedure and decrease complications. In addition, reports of volume adjustments using a mean 177 ml yields additional 1.7 kg/month wt loss. It has been suggested that adjusting with larger volumes will yield better results. We report our experience with the Spatz 3 device in 7 centers.

Aims: To determine the difference between the reported results of the original Spatz Adjustable balloon System and the new Spatz3 Adjustable balloon System with respect to ease of use, complications, weight loss results and the effect of larger volume adjustments.

Methods: 158 patients with mean BMI 40.1; mean weight 109 kg; mean age 37; were implanted with the Spatz3 device. Mean balloon volume was 473 ml (400-600). Adjustments were made for intolerance or weight loss plateau.

Results: All endoscopists felt that the Spatz 3 device was easier to use than the original Spatz adjustable balloon system device. Mean wt loss at 12 weeks was 12.5 kg with an 11.7% wt loss and 28.8 % EWL (% excess wt loss). At 24 weeks mean wt loss was 16.2 kg; 16.7% wt loss, and 35.3 % EWL. 94 patients reached 9 months with a reported mean wt loss of 23.2 kg; 20.4 % weight loss; and 44.9 % EWL. 48 patients reached 12 months with a reported mean wt loss of 24.1 kg; 20.6 % weight loss; and 48.1 % EWL. There were 49 balloon volume adjustments: 11 downward adjustments of 100 cc alleviated early intolerance, with added mean wt loss of 15.3 kg after the adjustment; 38 upward adjustments (mean 327 ml; range 150-500) at a mean 4.1 months yielded additional mean wt loss of 8.7 kg after the adjustment. 7 balloons were extracted; early intolerance and refusal to adjust volume downward (4); gastric ulcer (2); deflation (1).