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Aspire outcomes

Two-year AspireAssist outcomes comparable to surgery

AspireAssist System
Results indicate comparable weight loss at two-years to bariatric surgery

Two-year results of a 25-patient observational study of the AspireAssist System, published in the journal, BioMed Central Obesity, show that the system provided comparable weight loss at two-years to bariatric surgery, with excellent safety and minimal side effects.  In addition, the improvement in HbA1C of patients with type 2 diabetes was notable. After completing two years of therapy, patients achieved 61.5% mean excess weight loss (52.9lbs).  Patients were also assessed for quality of life and showed significant improvement, compared to baseline.

The study was a single-centre, observational, one-year study, conducted at Blekinge County Hospital in Karlskrona, Sweden, a non-investigational setting.  Patients were consecutively recruited after advertisement in a local newspaper. Inclusion criteria were BMI35 and age from 25 to 65 years. Exclusion criteria were myocardial infarction during the prior three months, known malignancy, chronic liver or kidney disease, prior upper GI tract surgery, substance abuse, eating disorders, and mental retardation.  Patients were not screened for motivation and had the option of continuing the study after the first year. 

“With only 1% of patients with morbid obesity opting for bariatric surgery in any one year, there is a clear need for a safe, effective, and long-term alternative. The AspireAssist data is a compelling and I look forward to offering this therapy to my patients,” said Dr Nancy Bohannon, an endocrinologist in San Francisco, California, with affiliation with California Pacific Medical Center. 

The AspireAssist, an endoscopic alternative to weight loss surgery, is indicated for adults with a BMI35-55.  The device is implanted in a 15-minute outpatient procedure, is fully reversible, and does not alter the patient’s internal anatomy. The AspireAssist received premarket approval from the Food & Drug Administration in June 2016, and is now available commercially in the US, Europe, Australia, and New Zealand.

The paper, ‘Aspiration therapy for obesity; a safe and effective treatment’, sought to evaluate weight loss, safety and quality of life with AspireAssist treatment for one to two years in obese subjects. Twenty-five obese subjects were enrolled between July and September 2012

Twenty of the subjects (80%, one man and 19 women) completed the intended 12-months of aspiration therapy, although five subjects withdrew from the study prior to one-year, primarily due to lack of motivation and unwillingness to comply with the regimen. Sixteen subjects experienced the Aspire method functioning and decided to continue treatment for a second year.

One of the 16 subjects withdrew before completion of the second year. In one case the proximal end of the A-tube had migrated from the fundus of the stomach down into the bulb of the duodenum and thereby constituting an outlet obstruction which was consistent with the vomiting and nausea reported by the patient. In all subjects that aborted the treatment, the A-tubes were removed in a secondary gastroscopy and the fistula closed spontaneously thereafter.

Frequency of aspirations was registered in a personal diary during the first year of treatment. Aspiration three times daily was reported for 76% of days for subjects in active treatment and the frequency of aspirations was reduced after consistent weight loss.

Mean baseline weight was 107.4 kg (SD 18.7) and mean baseline excess weight (defined as weight exceeding BMI 25) was 40.2 kg (SD 13.8). Mean excess weight loss per protocol was 54.4% (SD 28.8) at 12 months and 61.5% (SD 28.5) at 24 months (Figure 1).

Figure 1: Weight loss during 24 months aspiration therapy. Baseline is “-1 month” followed by 4 weeks very low calorie diet before insertion of A-tube at “0 months”. Excess weight is weight exceeding BMI of 25. Data are presented as mean values with standard deviation. a Weight. b Body Mass Index. c Excess weight loss

Among the seven diabetic patients there was a significant reduction in glycosylated haemoglobin type A1c (HbA1c) level from median 47 (IQR 43–66)mmol/mol to median 42 (IQR 36–64)mmol/mol, p = 0.03. Some of the subjects were able to reduce or withdraw their oral medications for diabetes.

Subjects reported that quality of life, as measured with EQ-5D and VAS, significantly increased during treatment.

“Aspiration therapy is a safe method that allows the motivated obese patient to reduce his or her excess weight by half, thus improving quality of life, in one year’s time,” the authors conclude. “Long term results remain still to be investigated.”

“Publication of this study is important as it demonstrates significant and durable weight-loss in patients with morbid obesity in a community-setting,” said Dr Katherine Crothall, President & CEO of Aspire Bariatrics. “This publication, in conjunction with other publications in peer-reviewed journals, goes a long way towards Aspire developing the body of evidence for widespread insurance coverage.”

To access this paper, please click here

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