The AspireAssist device (Aspiration Bariatrics, King of Prussia, Pennsylvania and Mina Medial, Sweden), with which obese patients pump out a third of the contents of their stomach after eating their main meals, was safe and effective for compliant patients out to 2 years, in a small prospective, observational study .
Erik Norén, MD, and Henrik Forssell, MD, from Blekinge County Hospital, in Karlskrona, Sweden, evaluated safety of the device and weight loss, as well as quality of life, in 25 obese subjects in the new study published online December 28, 2016 in BMC Obesity.
As previously reported by Medscape Medical News, this obesity-treatment device was approved by the US Food and Drug Administration (FDA) last June, based on a randomized clinical 1-year trial in which 111 patients lost 12% of their weight with the AspireAssist compared with 60 control patients who lost 3.6% of their weight.
The current study found that 20 patients of 25 recruited for an exploratory safety and efficacy trial in Sweden were still using the device at 1 year; 16 patients agreed to continue using it for another year and 15 patients actually did so.
On average, the patients initially weighed 107 kg, which included 40 kg of excess weight (above the weight for a body mass index [BMI] of 25).
After 1 year, patients using the device had lost a mean of 54% of their excess weight, and at 2 years, the patients who still used the device had lost a mean of 62% of their excess weight.
"This weight loss surpassed our expectation and is nearly at the level of gastric bypass procedure and other major abdominal surgery for obesity," Drs Norén and Forssell write.
The patients reported improved quality of life, and there were no serious adverse events or electrolyte disorders. The seven patients with type 2 diabetes had improvements in HbA1c levels.
Thus, "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 1 year's time," the researchers conclude.
But patients have to be motivated to succeed, they stress.
"Today we have no means of predicting compliance, but orderly persons with a capacity to follow daily routines seem to have a higher probability of success," they observe.
Compared with bariatric surgery, "aspiration therapy provides a reversible, easily performed outpatient procedure that does not entail the risks associated with major abdominal surgery," note Drs Norén and Forssell.
The AspireAssist device is also not without its critics. The president of the Academy of Eating Disorders has called on the FDA to reverse approval, saying it could lead to potentially life-threatening disorders such as bulimia and binge-eating.
A Feeding Tube in Reverse
The endoscopic procedure to insert the tube from the patient's stomach to the surface of their abdomen is done under conscious sedation and resembles percutaneous endoscopic gastrostomy, in which a feeding tube is placed in the stomach. After about 2 weeks, the patient is fitted with a skin port.
Then three times a day, after breakfast, lunch, and supper, the patient attaches the aspiration device and performs several cycles of infusing water into the stomach and draining stomach contents into the toilet.
Previously, Shelby Sullivan, MD, director of bariatric endoscopy at Washington University School of Medicine in St Louis, Missouri, and colleagues showed, in a 1-year randomized pilot study in 17 patients (Gastroenterology. 2013;145: 1245–1252), that "aspiration therapy does not induce any adverse eating behaviors or change baseline depression scores," Drs Norén and Forssell note.
For the current study, they recruited 25 obese patients seen at their center in Sweden who had a BMI >35 kg/m2, were 25 to 65 years old, and had no substance-abuse or eating disorder or other exclusion criteria. The 23 women and two men had a mean age of 48 and a mean BMI of 40 kg/m2.
The patients were fitted with the device, received instructions for use, and had two individual and six group sessions of cognitive behavioral therapy.
Patients reported improved quality of life at 1 year, based on questionnaire replies.
The researchers did not find any evidence of increased urinary potassium secretion, which could lead to chronic hypokalemia and risk of cardiac arrhythmia.
During the first postoperative week, 13 patients (52%) reported moderate pain; 9% reported severe pain; and two patients were admitted to the hospital for suspicion of leakage or tube displacement.
Longer-term patency is still unknown, Drs Norén and Forsell caution. "It is our belief that once the desired weight goal is achieved, many, if not most, patients will need to continue aspiration therapy, albeit possibly at a reduced frequency, to maintain weight stability," they speculate.
They are now starting a prospective 5-year study to compare 50 patients who receive aspiration therapy vs 50 patients who receive laparoscopic gastric bypass.
The study was funded by Mina Medical and Aspire Bariatrics. The authors declare they have no relevant financial relationships. Dr Forssell passed away after a short illness during submission of the article.
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BMC Obes. 2016;3:56. Article
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Cite this: 'Stomach Pump' Works in Motivated Obese Patients: 2-Year Study - Medscape - Jan 12, 2017.
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