One-year adjustable intragastric balloons: results in 73 consecutive patients in the U.K.
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.
Spatz FGIA, Inc, Great Neck, NY, USA, jeff@spatzmedical.net.
J
J
Brooks
E D
ED
Srivastava
E M H
EM
Mathus-Vliegen
D000328:Adult; D000368:Aged; D015992:Body Mass Index; D020878:Device Removal / Q000706:statistics & numerical data*; D004868:Equipment Failure / Q000706:statistics & numerical data*; D005260:Female; D005500:Follow-Up Studies; D015905:Gastric Balloon; D006801:Humans; D008297:Male; D008875:Middle Aged; D009767:Obesity, Morbid / Q000453:epidemiology / Q000628:therapy*; D017060:Patient Satisfaction; D016896:Treatment Outcome; D006113:United Kingdom / Q000453:epidemiology; D015431:Weight Loss