Background: Most intragastric balloons have 6-month approval. We report results with the Spatz Adjustable Balloon: approved for 12 months and adjustable.
Methods: Seventy-three patients (mean: age 45.5; weight 114.5 kg; BMI 36.6 kg/m2) scheduled for 1-year implantation with Spatz balloon (mean volume 417 ml saline). Adjustments performed for early intolerance and weight loss plateau.
Results: Three patients failed insertion. There were 21 early removals (4 intolerant refusing adjustment; 3 deflations; 14 satisfied patients) leaving 49 patients at 12 months. Results of 70 patients (49 patients at 12 months and 21 patients at <12 months) were a mean 21.6 kg weight loss; 19% weight loss; and 45.7% EWL (excess weight loss). Ten intolerant patients were adjusted and lost additional mean 13.2 kg. Fifty-one patients with weight loss plateau scheduled for adjustment: adjustments failed in 6 and non-response in 7. The adjusted 38 patients lost an additional mean 9.4 kg and at extraction had mean 40.9% EWL with 18.7% weight loss. Three catheter impactions required surgical extraction, and three deflated balloons didn't migrate beyond stomach.
Conclusions: The Spatz balloon is an effective procedure without mortality; however, it carries a risk of catheter impaction necessitating surgical extraction (4.1%). The failure rate--4.1%; intolerance without ability to adjust balloon--5.5%; major complications occurred in 3 (4.1%); minor (balloon deflations) in 3 (4.1%), and 2 asymptomatic gastric ulcers at extraction (2.7%). The longer implantation period and adjustment option combine to produce greater weight loss, albeit <10% weight loss beyond the pre-adjustment weight loss.