Top

Published in:

Open Access 01-07-2018 | Original Contributions

Aspiration Therapy As a Tool to Treat Obesity: 1- to 4-Year Results in a 201-Patient Multi-Center Post-Market European Registry Study

Authors: Max Nyström, Evzen Machytka, Erik Norén, Pier Alberto Testoni, Ignace Janssen, Jesus Turró Homedes, Jorge Carlos Espinos Perez, Roman Turro Arau

Published in: Obesity Surgery | Issue 7/2018

Abstract

Purpose

The objective of this post-market study was to evaluate long-term safety and efficacy of aspiration therapy (AT) in a clinical setting in five European clinics.

Materials and Methods

The AspireAssist® System (Aspire Bariatrics, Inc. King of Prussia, PA) is an endoscopic weight loss therapy utilizing a customized percutaneous endoscopic gastrostomy tube and an external device to aspirate approximately 30% of ingested calories after a meal, in conjunction with lifestyle counseling. A total of 201 participants, with body mass index (BMI) of 35.0–70.0 kg/m², were enrolled in this study from June 2012 to December 2016. Mean baseline BMI was 43.6 ± 7.2 kg/m².

Results

Mean percent total weight loss at 1, 2, 3, and 4 years, respectively, was 18.2% ± 9.4% (n/N = 155/173), 19.8% ± 11.3% (n/N = 82/114), 21.3% ± 9.6% (n/N = 24/43), and 19.2% ± 13.1% (n/N = 12/30), where n is the number of measured participants and N is the number of participants in the absence of withdrawals or lost to follow-up. Clinically significant reductions in glycated hemoglobin (HbA1C), triglycerides, and blood pressure were observed. For participants with diabetes, HbA1C decreased by 1% (P < 0.0001) from 7.8% at baseline to 6.8% at 1 year. The only serious complications were buried bumpers, experienced by seven participants and resolved by removal/replacement of the A-Tube, and a single case of peritonitis, resolved with a 2-day course of intravenous antibiotics.

Conclusion

This study establishes that aspiration therapy is a safe, effective, and durable weight loss therapy in people with classes II and III obesity in a clinical setting.

Trial Registration

ISRCTN 49958132

Available only for authorised users

Klein S, Wadden T, Sugerman HJ. American Gastroenterological Association technical review: clinical issues in obesity. Gastroenterology. 2002;123(3):882–932. https://doi.org/10.1053/gast.2002.35514.CrossRefPubMed

OECD (2016), “Overweight and obesity”, in OECD Factbook 2015–2016: economic, environmental and social statistics, OECD Publishing, Paris, DOI: https://doi.org/10.1787/factbook-2015-en.

Basterra-Gortari FJ, Beunza JJ, Bes-Rastrollo M, et al. Increasing trend in the prevalence of morbid obesity in Spain: from 1.8 to 6.1 per thousand in 14 years. Rev Esp Cardiol. 2011;64(5):424–6. https://doi.org/10.1016/j.recesp.2010.06.010.CrossRefPubMed

Katzmarzyk P, Mason C. Prevalence of class I, II and III obesity in Canada. CMAJ. 2006;174(2):156–7. https://doi.org/10.1503/cmaj.050806.CrossRefPubMedPubMedCentral

Freedman DS, Khan LK, Serdula MK, et al. Trends and correlates of class 3 obesity in the United States from 1990 through 2000. JAMA. 2002;288(14):1758–61. https://doi.org/10.1001/jama.288.14.1758.CrossRefPubMed

Health and Social Care Information Centre (2011) Health survey for England—2010, trend tables. Available: http://www.ic.nhs.uk/pubs/hse10trends.

Keating C, Backholer K, Gearon E, et al. Prevalence of class-I, class-II and class-III obesity in Australian adults between 1995 and 2011–12. Obesity Research & Clinical Practice. 2014;9(6):553–62.CrossRef

Kitahara C, Flint A, de Gonzalez A, et al. Association between class III obesity (BMI of 40–59 kg/m2) and mortality: a pooled analysis of 20 prospective studies. PLoS Med. 2014;11(7):e1001673. Published online 2014 Jul 8. https://doi.org/10.1371/journal.pmed.1001673.CrossRefPubMedPubMedCentral

Sjöström L, Lindroos AK, Peltonen M, et al. Lifestyle, diabetes, and cardiovascular risk factors 10 years after bariatric surgery. N Engl J Med. 2004;351(26):2683–93. https://doi.org/10.1056/NEJMoa035622.CrossRefPubMed

10.

Xia Y, Kelton CM, Guo JJ, et al. Treatment of obesity: pharmacotherapy trends in the United States from 1999 to 2010. Obesity. 2015;23(8):1721–8. https://doi.org/10.1002/oby.21136.CrossRefPubMed

11.

Buchwald H, Oien D. Metabolic/bariatric surgery worldwide 2011. Obes Surg. 2013;23(4):427–36. https://doi.org/10.1007/s11695-012-0864-0.CrossRefPubMed

12.

Food and Drug Administration, Summary of safety & efficacy, AspireAssist, P150034.

13.

Sullivan S, Stein R, Jonnalagadda S, et al. Aspiration therapy leads to weight loss in obese subjects: a pilot study. Gastroenterology. 2013;145(6):1245–52. https://doi.org/10.1053/j.gastro.2013.08.056.CrossRefPubMedPubMedCentral

14.

Thompson C, Abu Dayyeh B, Kushner R, et al. Percutaneous gastrostomy device for the treatment of class II and class III obesity: results of a randomized controlled trial. Am J of Gastro. 2017;112(3):447–57. https://doi.org/10.1038/ajg.2016.500.CrossRef

15.

Norén E, Forssell H. Aspiration therapy for obesity; a safe and effective treatment. BMC Obesity. 2016;3(1):56. https://doi.org/10.1186/s40608-016-0134-0. CrossRefPubMedPubMedCentral

16.

Grant DG, Bradley PT, Pothier DD, et al. Complications following gastrostomy tube insertion in patients with head and neck cancer: a prospective multi-institution study, systematic review and meta-analysis. Clin Otolaryngol. 2009;34(2):103–12. https://doi.org/10.1111/j.1749-4486.2009.01889.x.CrossRefPubMed

17.

McClave S, Neff RL. Care and long-term maintenance of percutaneous endoscopic gastrostomy tubes. J of Parenteral and Enteral Nutrition. 2006;30(suppl1):S27–38. https://doi.org/10.1177/01486071060300S1S27.CrossRef

18.

Schrag S, Sharma R, Jiaik N, et al. Complications related to percutaneous endoscopic gastrostomy (PEG) tubes: a clinical review. J Gastrointestin Liver Dis. 2007;16(4):407–18.PubMed

19.

Grant J. Percutaneous endoscopic gastrostomy: initial placement by single endoscopic technique and long-term follow-up. Ann Surg. 1992;217(2):168–74.CrossRef

20.

Itkin M, DeLegge MH, Fang JC, et al. Multidisciplinary practical guidelines for gastrointestinal access for enteral nutrition and decompression from the Society of Interventional Radiology and American Gastroenterological Association (AGA) Institute, with endorsement by Canadian Interventional Radiological Association (CIRA) and Cardiovascular and Interventional Radiological Society of Europe (CIRSE). Gastroenterology. 2011;141(2):742–65. https://doi.org/10.1053/j.gastro.2011.06.001.CrossRefPubMed

21.

Ponsky JL, Gauderer MW. Percutaneous endoscopic gastrostomy: a nonoperative technique for feeding gastrostomy. Gastrointest Endosc. 1981;27(1):9–11. https://doi.org/10.1016/S0016-5107(81)73133-X.CrossRefPubMed

22.

Nicholson FB, Korman MG, Richardson MA. Percutaneous endoscopic gastrostomy: a review of indications, complications and outcome. J Gastroenterol Hepatol. 2000;15(1):21–5. https://doi.org/10.1046/j.1440-1746.2000.02004.x.CrossRefPubMed

23.

Wiggins TF, Garrow DA, DeLegge MH. Evaluation of percutaneous endoscopic feeding tube placement in obese patients. Nutr Clin Pract. 2009;24(6):723–7. https://doi.org/10.1177/0884533609349250.CrossRefPubMed

24.

Bochicchio GV, Guzzo JL, Scalea TM. Percutaneous endoscopic gastrostomy in the supermorbidly obese patient. JSLS. 2006;10(4):409–13.PubMedPubMedCentral

25.

Hibbard JH, Greene J. What the evidence shows about patient activation: better health outcomes and care experiences; fewer data on costs health affairs. 2013;32(2):207–14. https://doi.org/10.1377/hlthaff.2012.1061.

Title: Aspiration Therapy As a Tool to Treat Obesity: 1- to 4-Year Results in a 201-Patient Multi-Center Post-Market European Registry Study
Authors: Max Nyström
Evzen Machytka
Erik Norén
Pier Alberto Testoni
Ignace Janssen
Jesus Turró Homedes
Jorge Carlos Espinos Perez
Roman Turro Arau
Publication date: 01-07-2018
Publisher: Springer US
Published in: Obesity Surgery / Issue 7/2018
Print ISSN: 0960-8923
Electronic ISSN: 1708-0428
DOI: https://doi.org/10.1007/s11695-017-3096-5

At a glance: The STEP trials

Springer Medicine

Aspiration Therapy As a Tool to Treat Obesity: 1- to 4-Year Results in a 201-Patient Multi-Center Post-Market European Registry Study

Abstract

Purpose

Materials and Methods

Results

Conclusion

Trial Registration

At a glance: The STEP trials

Springer Medicine

Abstract

Purpose

Materials and Methods

Results

Conclusion

Trial Registration

Please log in to get access to this content

Other articles of this Issue 7/2018

New Modality of Treatment for Malnutrition After Laparoscopic Roux-en-Y Gastric Bypass: the “Small Bowel Limb Transposition” Technique

Serum Parathyroid Hormone and 25-Hydroxyvitamin D Concentrations Before and After Biliopancreatic Diversion

Liraglutide Effects on Upper Gastrointestinal Investigations: Implications Prior to Bariatric Surgery

Trends in Early Morbidity and Mortality after Sleeve Gastrectomy in Patients over 60 Years

ReShape Intragastric Balloon Complicated by Gastric Perforation and Peritonitis

Invited Response Letter: “Gastrointestinal Stromal Tumor After Laparoscopic Sleeve Gastrectomy: Be Awake Before, During, and After a Bariatric Procedure”