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One-year Adjustable Intragastric Balloons: Results in 73 Consecutive Patients in the UK

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Abstract

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.

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Disclosure

Dr Jeffrey Brooks is a shareholder and serves as CEO of Spatz FGIA, Inc. which manufactures the Spatz device. Dr Srivastava and Dr Mathus-Vliegen have no conflict of interest to report.

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Authors and Affiliations

  1. Spatz FGIA, Inc, Great Neck, NY, USA

    J. Brooks

  2. Departments of Gastroenterology, Medical Microbiology, and Pathology, University Hospital of Wales, Cardiff, UK

    E. D. Srivastava

  3. Gastroenterology and Hepatology, Academic Medical Centre, University of Amsterdam, Amsterdam, The Netherlands

    E. M. H. Mathus-Vliegen

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  1. J. Brooks
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  2. E. D. Srivastava
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  3. E. M. H. Mathus-Vliegen
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Correspondence to J. Brooks.

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Brooks, J., Srivastava, E.D. & Mathus-Vliegen, E.M.H. One-year Adjustable Intragastric Balloons: Results in 73 Consecutive Patients in the UK. OBES SURG 24, 813–819 (2014). https://doi.org/10.1007/s11695-014-1176-3

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