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

Autor: Nyström M; Department of Surgery, Blekinge County Hospital, Lasarettsvägen, 371 85, Karlskrona, Sweden. max.nystrom@ltblekinge.se., Machytka E; University Hospital Ostrava, Pionyru 690, 250 81, Nehvizdy, Czech Republic., Norén E; Department of Surgery, Blekinge County Hospital, Lasarettsvägen, 371 85, Karlskrona, Sweden., Testoni PA; Department of Gastroenterology, Ospedale San Raffaele, Via Olgctnna, 60, 20132, Milan, Italy., Janssen I; Dutch Obesity Clinics, Amersfoortseweg 43, 3712 BA, Huis ter Heide, The Netherlands., Turró Homedes J; Endoscopia Digestiv, Centro Medico Teknon, Carrer Vilana, 12, 08022, Barcelona, Spain., Espinos Perez JC; Endoscopia Digestiv, Centro Medico Teknon, Carrer Vilana, 12, 08022, Barcelona, Spain., Turro Arau R; Endoscopia Digestiv, Centro Medico Teknon, Carrer Vilana, 12, 08022, Barcelona, Spain.
Jazyk: angličtina
Zdroj: Obesity surgery [Obes Surg] 2018 Jul; Vol. 28 (7), pp. 1860-1868.
DOI: 10.1007/s11695-017-3096-5
Abstrakt: 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/m 2 , were enrolled in this study from June 2012 to December 2016. Mean baseline BMI was 43.6 ± 7.2 kg/m 2 .
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.
Databáze: MEDLINE
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