There’s a new FDA-approved weight-loss device out there that have a pretty big ick factor for some. It’s called the AspireAssist. Basically, it’s a tube, known as a gastrostomy tube, that is inserted through your skin into your stomach. There is a disk-shaped Skin-Port valve that connects to the tube at the skin level and holds it in place. After a meal, you connect the valve to an external device that allows a portion of the stomach’s contents to drain by gravity into the toilet. After draining the stomach the first time, you flush the stomach with water from the attached reservoir and drain it again. It is estimated that this system removes about 30% of calories consumed in a meal.
You have to chew your meal well so that large food particles don’t clog the valve. And, you have to perform this procedure about 20 to 30 minutes after you finish your meal. This seems socially problematic to me (to say the least): “Hey guys, excuse me but I have to go dump some of my meal in the toilet.” That being said, I am all for innovations that help people lose a lot of weight (target users have BMIs in the 35 to 55 kg/m² range) because if you have ever tried it, you know that it is really, really hard.
So, I wanted to know if there was any evidence that it works without causing unacceptable or dangerous side effects. Here is what I learned from an August 29, 2016 review of the product in The Medical Letter, a reliable and unbiased source of information about drugs and other therapeutics.
According to the FDA approval summary, the manufacturer conducted a 52-week, open-label trial called PATHWAY. In that trial, whose results are available only in abstract form (available for purchase), 111 of 171 patients were randomized to treatment with the AspireAssist plus lifestyle counseling on diet, exercise, and behavior. The other 60 patients only received lifestyle counseling. The AspireAssist group,
“…lost an average of 31.2 pounds or 31.5% of excess weight (12.1% of total body weight). The control group lost 9 pounds or 9.8% of excess weight (3.5% of total body weight), a significant difference.”
A second primary endpoint, the percent of patients who achieved at least a 25% excess weight loss, was not met.
How does AspireAssist compare to other bariatric procedures?
Although it is less effective than the big surgeries (e.g., biliopancreatic diversion and Roux-en-Y gastric bypass, which have success rates of >70% and 66%), based on this one study, it appears to be somewhat better than the gastric balloon. It is important to note that we don’t yet have any information about whether this procedure can improve Type 2 Diabetes, a highly desirable outcome and one that is seen with the more invasive procedures, such as gastric bypass.
This Table, a screenshot from the Medical Letter review summarizes the relative efficacies:
Side effects and complications
The most frequently reported side effects were abdominal pain or discomfort in the perioperative period and granulation tissue and irritation in the area of the stoma (the hole in the stomach wall) after the surgery. According to The Medical Letter, most of the side effects resolved within 30 days.
The device is not for everyone
The FDA approval notice notes “that the device should not be used in patients who
- Have had previous abdominal surgery that significantly increases the medical risks of gastrostomy tube placement
- Have esophageal stricture, pseudo-obstruction, severe gastroparesis, or gastric outlet obstruction, inflammatory bowel disease
- Have a history of refractory gastric ulcers
- Have ulcers, bleeding lesions, or tumors discovered during endoscopic examination
- Have uncontrolled hypertension (blood pressure >160/100)
- Have a history or evidence of serious pulmonary or cardiovascular disease, including acute coronary syndrome, heart failure requiring medications, or NYHA (New York Heart Association) class III or IV heart failure
- Have coagulation disorders (platelets < 50,000, PT > 2 seconds above control or INR > 1.5)
- Have anemia (hemoglobin <8.0 g/dL in women and <10.0 g/dL in men)
- Are pregnant or lactating
- Are diagnosed with bulimia or binge eating disorder
- Have night eating syndrome
- Have chronic abdominal pain that would potentially complicate the management of the device
- Have a physical or mental disability, or psychological illness that could interfere with compliance with the therapy
- Are at high risk of having a medical complication from the endoscopic procedure or AspireAssist therapy weight loss program for any reason, including poor general health or severe organ dysfunction.”
The bottom line
Based on a small trial, it appears this device might be helpful for some obese patients. And, it is less invasive than full-blown bariatric surgery. However, we really don’t have much data yet to support its use, and the long list of contraindications include some that are worrisome, in particular, eating disorders. (Could this be considered an alternative to self-induced vomiting?)
Further, there are so many unanswered questions:
- Is the weight loss sustained after the device is removed?
- Are there any serious medical, nutritional, psychological side effects?
- What are the short and long-term impacts on quality of life?
- Does the device improve or reverse Type 2 diabetes?
- Will it be affordable? What is the price and will insurers cover it?
Until we know the answers to these questions, it will remain unclear where the AspireAssist fits into our growing armamentarium of treatments for obesity not resolved by attempts at altering lifestyle.
The bottom bottom line
Patients embracing this technology is, of course, the double-bottom line. So I thought I would close with a testimonial from Hampus Lager, a 28 year Swede, who lost 110 pounds in 9 months by using the device: