Spatz 1 Publications

Presented at DDW 2012

Adjustable Intragastric Balloon: The first patient experience in Spain

Lopez-Nava G 1, Nebreda J 2,  Gostout C 3, Brooks, J 4.

 

Hospital Sanchinaro, Madrid, Spain, Opcion Medica Group, Barcelona, Spain,  3 Mayo Clinic, Rochester, United States,  Consultant Gastroenterologist, Spatz FGIA INC, New York, United States

 

Background: A new intragastric balloon (IGB) has been released that has volume adjustment capability and has been approved for one year implantation. These new functions have been developed to address the following limitations of current IGB technology; (1) up to 7% intolerance in the first two weeks requiring explantation; (2) loss of balloon effect within three to four months; (3) patient’s request for a longer implantation time.

After implanting more than 3,500 BIB balloons, we are reporting our preliminary experience with the Spatz adjustable IGB in 152 patients in Madrid and Barcelona, Spain.

Methods: 152 patients with a mean BMI of 38.5 (29.1 to 55.7); mean weight of 104.9 kg (79.4 to 180); mean age of 39.3 (17 to 63); were implanted with the SpatzAdjustable Balloon system (ABS) for twelve months. Mean balloon volume was 469.8 cc (400 to 600 cc). Balloon volume adjustments were made for intolerance or weight loss plateau. Post implantation and post adjustment symptoms were monitored. Patients were seen once or twice monthly by the endocrinologist, dietician or gastroenterologist.

Results: Implantation times averaged 12 minutes, although the first 5 implantation times took approximately 20 minutes each. Adjustment times averaged 5 to 15 minutes, depending on stomach contents. Post implantation symptoms of nausea, vomiting and pain were stronger than post adjustment symptoms, yet symptoms lingered a day longer post adjustment.

 

See Table for results.

Weeks Implanted  # Patients Weight Loss (kg) % EWL
12 125 14.8 36.2
24 65 21.1 45.7
36 27 26.7 57.1
52 15 30.6 59.7

 

17 adjustments were successfully performed. Five downward adjustments performed (mean 160 cc with a range of 150 to 200 cc) within the first two weeks alleviated intolerance, with continued weight loss averaging 3.9 kg/month. Twelve upward adjustments (mean 186 cc with a range of 100 to 300 cc) performed on average at month 3.2 produced a mean additional weight loss of 1.7 kg/month. Ten balloons were extracted for various reasons; reached goal weight (3); psychological intolerance (2); symptom intolerance in the first 2 weeks and refusal to proceed with downward adjustment (3); gastric ulcer (1); pyloric entry of the distal catheter tip with duodenal ulcer(1).

Conclusion: The Spatz adjustable balloon has been successfully implanted in 152 patients.  1) Implantation and adjustment times were quick and reflect a short learning curve. 2) Upward adjustments yielded additional weight loss.  2) Downward adjustments alleviated intolerance, yet yielded continued weight loss. 3) Extraction is readily performed by snare. 4) Symptoms post implantation were stronger than post-adjustment, but averaged a day longer post-adjustment.  5) The results thus far from scheduled one year implantation with an adjustable balloon are encouraging.

 

References:

1. Mathus-Vliegen EM. Intragastric balloon treatment for obesity: what does it really offer? Dig Dis.

2008; 26(1):40-4. Epub 2008 Feb 15. Review

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Results reported from Wales, UK

(Publication submitted and currently under review)

Adjustable Intragastric Balloons: One-year results in 73 consecutive patients in the UK.

Brooks J, Srivastava ED, Mathus-Vliegen EMH

 

Reports 24 kg weight loss at 12 months. 

 

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Our clinical trial has been published in Obesity Surg Journal** and are summarized below:

  • In this feasibility study of a novel adjustable IGB, we report a mean wt loss of:

        –   15.6 kg (26.4% EWL) at 24 weeks

        –   20.4 kg (40.4% EWL) at 36 weeks

        –   24.4 kg (48.8% EWL) at 52 weeks

  • After weight loss plateau, balloon volume upward adjustments produced 8.1 kg additional weight loss in 10 patients.
  • Intolerance was treated with downward volume adjustments in 6 patients yielding patient comfort, and additional weight loss of 4.6 kg.
  • Early nausea in 2 patients that would have required IGB removal was successfully managed with downward volume adjustment.

 

Adjustable Intragastric Balloons: A 12-Month Pilot Trial in Endoscopic Weight Loss Management.

Machytka E, Klvana P, Kornbluth A, Peikin S, Mathus-Vliegen LE, Gostout C, Lopez-Nava G, Shikora S, Brooks J.

Obes Surg. 2011 Oct;21(10):1499-507.