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

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

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.

Keywords: Aspiration therapy endoscopic weight loss.

Conflict of interest statement

Dr. Evzen Machytka received speaker and instructor honoraria, as well as consulting fees, from Aspire Bariatrics, Inc. Dr. Roman Turro Arau has received speaker and instructor honoraria from Aspire Bariatrics, Inc. The other authors declare that they have no conflict of interest.

Figures

Fig. 1
Fig. 1
AspireAssist A-Tube with Skin-Port and external device. Individual components of the AspireAssist device are labeled
Fig. 2
Fig. 2
Participant disposition

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