The AspireAssist® System (Aspire Bariatrics, Inc. King of Prussia, PA) is a weight-loss device, with which patients aspirate approximately 30% of ingested calories after a meal utilizing a customized percutaneous endoscopic gastrostomy tube, in conjunction with lifestyle (diet and exercise) counselling. The objective of this study was to record long-term safety and efficacy data on the AspireAssist in a clinical setting.
A total of 160 patients were enrolled from June 2012 to December 2016 in this 5-center post-market observational study: University of Ostrava (Ostrava, Czech Republic), Blekinge County Hospital (Karlskrona, Sweden); Centro Médico Teknon (Barcelona, Spain), Rijnstate Ziekenhuis (Arnhem, Holland), and Ospedale San Raffaelle (Milan, Italy). Mean baseline BMI (range 35.0-73.8) was 44.9 + 7.9 kg/m2.
We compared patients across different levels of psychological well-being (measured using the Beck Depression Inventory: <=13, n=111; >13, n=24). We also compared patients across different genders (female, n= 146; male, n=34), ages (<42yo, n=80; >=42, n= 101), races (White, n=57; Hispanic, n=43; African American, n=36), educations (high school only, n=43; 1-2 years of college, n=32; 4-years of college+, n =37), employment statuses (employed, n=104; unemployed, n=12) and marital statuses (single, n=45; married, n=60; divorced, n=13). Our results demonstrate that females exhibit a significantly higher %EBL than do males (70% vs. 62%, p= 0.03). Similarly, patients with Beck Depression Inventory (BDI) scores <= 13 exhibit a significantly higher %EBL than do those with BDI scores >13 (70% vs. 59%, p= 0.02). No significant difference in %EBL is seen across different ages, races, educations, employment statuses or marital statuses. Patients who are married exhibit a significantly reduced LOS compared to patients who are single (1.69 vs. 1.97, p=0.04). No significant difference in LOS is seen across different BDI scores, genders, ages, races, educations or employment statuses. As of December 31, 2016, 117, 78, 23, and 12 patients have completed 1, 2, 3, and 4 years of therapy, respectively. Of the 160 enrolled patients, 43 have had their gastrostomy tube removed and discontinued Aspiration Therapy: 12, 26, 3, 1, and 1 patients in the 1st, 2nd, 3rd, 4th, and 5th years, respectively. Reasons for discontinuation includes (i) achievement of goal weight and maintenance of goal weight without aspiration therapy (n=16), (ii) inability or unwillingness to adhere to therapy (n=8), (iii) fatigue from therapy (n=8), (iv) decision to pursue bariatric surgery (n=4), (v) discomfort with the device (n=4), unrelated health issues (2), and economic issues (1). Mean (±SD) percent weight-loss for patients who completed 1, 2, 3, and 4 years of therapy was 24.3% (13.9%), 26.6% (17.3%), 30.3% (15.3%), and 25.1% (19.1%), respectively, while mean (±SD) excess weight-loss was 48.3% (26.0%), 50.0% (27.9%), 52.5% (24.4%), and 47.9% (36.2%), respectively. In the perioperative period, six patients were hospitalized for observation and analgesic administration for treatment of pain and air in abdomen. In the post-operative period, 3 patients had endoscopies to replace their A-Tubes because of buried bumpers. Except for the aforementioned hospitalizations and endoscopies, all other complications were treated conservatively, with the most frequent complication being pain in the perioperative period and stomal skin irritation/ granulation tissue in the post-operative period. There has been no evidence to date of the development of any metabolic abnormality, nor any abnormal eating behaviors in patients in this study.
Aspiration Therapy provides a safe, durable, and effective weight-loss method, for people with Class II and Class III obesity.