Monday, July 18, 2016

New weapon to battle obesity or folly?

The FDA recently approved the AspireAssist, a tube placed into the stomach through the abdominal wall enabling a patient to drain a portion of gastric contents after eating. The idea is to remove about 30% of food intake after each meal. Food must be thoroughly chewed and taken with plenty of water in order for the material to drain properly. The manufacturer suggests draining the gastric contents directly into a toilet.

When I first heard of this device three years ago, I expressed my usual skepticism. However, a recent multicenter study presented at this year’s Digestive Disease Week looked at the use of the AspireAssist with counseling to counseling alone found that morbidly obese patients who used the device lost more than 30% of their excess weight compared to only about 10% for those in the counseling group. Bear in mind that the figures are percent of excess weight lost, not percent of total weight lost.

An interesting article on Stat News featured comments from both proponents and detractors. Here are some of them:

We just don’t have enough data to evaluate how well it works, and how safe it is. It could turn out to be an effective option for some people just as easily as it could become yet another failed approach to weight loss.

I am highly doubtful that it will be an effective or durable weight loss tool.

I have worked with the AspireAssist device since 2009, helping refine its design and test it in clinical trials. It works, and I have seen many people swear by it because it helped them lose weight when nothing else had.

[the study’s authors] indicate that 26 percent of the volunteers who received the AspireAssist device withdrew from the 52-week study before it ended. That means over one-quarter of people could pay for the device but end up getting no benefit from it. Top reasons cited for withdrawal were lack of time or motivation. Further, 93 of the 111 subjects experienced 228 adverse events in the first year. Only approximately half of the volunteers continued using the device after 52 weeks.

While long-term outcomes have not yet been published, the reported one-year results were extremely positive. The AspireAssist helped highly satisfied volunteers lose an average of 15% of their starting weights.

How significant is a 15% weight loss? If a woman is 5’5” tall and weighs 300 pounds, her BMI would be 49.9 classifying her as severely morbidly obese. A 15% (45 pound) weight loss results in a weight of 255 pounds and a BMI of 42.4 leaving her with continued severe morbid obesity. Will it keep working after a year?

According to WebMD, the AspireAssist “including the device placement, lifestyle counseling, monitoring, and follow-up, is expected to cost about $8,000 to $13,000 for the first year.” How much of this would be paid by insurance is not clear.

Is it a worthwhile tool to fight obesity? I’m not sure.

Here’s what Stephen Colbert had to say.


Diane said...

Folly! Any teenage girl(well the vast majority of them) will share they wished for a device very much like this one the first time they had to wear a swimsuit with friends or became aware of dress sizes.. heck, the creator probably dreamed of it while playing with her barbies. As a woman who has struggled with her weight throughout life(thankfully right now a good weight and fitness level no dr. could argue) when I saw this device, I admit, I thought BINGO! My inner eating disorder saw it's appeal immediately. In a world where far too many patients are given feeding tubes instead of nutritional counseling, where the obese are told to lose weight and shamed by their Drs, employers, friends and family but at the same time are shamed because their skinny friends eat starbucks and McD's.. in a world where folks claim not to have time to "cook", this is only going to yet again skirt the issue. We eat too much crap and don't get the exercise we need. I know this because when I eat too much junk(talking premade foods, chemically altered and treated foods, high calorie low nutrition foods) and I don't get exercise I get fat- really fat! I have friends who have had gastric bypass and when the reality of what they are able to eat hits, they ALL admit they clearly over ate even when they thought they were dieting. Travel to another Country (with lower levels of obesity) and you better pack walking shoes and motrin- they walk, A LOT. IT is lifestyle and food and a mechanical version of bulimia is NOT a cure- it will only encourage the tidal wave of "easier is better". Jumping off my soapbox.

Anonymous said...

It seems to me to be a possible medically approved form of bulimia.

artiger said...

Looks like a glorified (and expensive) PEG tube to me.

I obviously missed the boat. For almost 20 years, I've been putting PEG tubes in people who couldn't take in enough calories; apparently I had the whole idea backwards.

Skeptical Scalpel said...

Diane, great rant. I'm happy to have provided you the opportunity.

Anon, others have said that too. It may be a little different because bulimia is a mental illness.

Artiger, haven't you ever heard the expression "A drain is a two-way street"?

Anonymous said...

Hmmm what about hypoglycemia, etc.? Just a lot of questions here.

Skeptical Scalpel said...

Good question. Except for abdominal pain and stomal issues, the specific adverse events were not listed in the abstract. Serious adverse events (again not specified) occurred in 3.6% of AspireAssist patients.

Anonymous said...

Another endoscopic option for weightloss is the magnet anastamosis between the jejunum and ilium

I thought we stopped doing jejunoilieal bypass because of the ridiculous complication rate?

William Reichert said...

Obesity, like a high cholesterol level, is not a disease. It is risk factor for disease. There needs to be evidence that this device leads to a longer life, free of the complications of the presence of this risk factor. Losing enough weight to accomplish this outcome seems dubious given that the patient can defeat the weight loss feature of the device simply by eating 30% more food before removing 30% eaten or simply not opening up the drain plug.
Losing weight is simple. Two things: Dont eat between meals.
Dont eat unless you are hungry. Simple but hard. There are so many reasons to eat besides hunger. Giving up on those for more than a year is almost impossible for most people for more than a year.
As an aside, as long as insurance exists to pay for "medical
care", the medical industrial complex will inevitably expand its
product line to meet the demands of medical care consumers until the cost of medical care equals, or dare I say exceeds, the
total gross national product of the American economy.
It is perplexing that this being the case, this issue of medical
costs have not received, so far, even a mention by the candidates for POTUS in the past year.Nor do I expect they will before the November election.

Skeptical Scalpel said...

Anon, yes the jejunal-ileal bypass has not been done for the last 30 years or so because it was fraught with complications. I don't know anything about the magnet anastomosis procedure for weight loss.

William, brilliant comments. You are right about the medical-industrial complex. I am amazed that the FDA approved this device.

Anonymous said...

Okay, I completely understand physicians' and surgeons' comments about the difficulty of treating and managing obese patients. I know that adipose tissue is fairly well vascularized, and the more there is, the more little blood vessels there are to leak. I know that all the extra fat in the omentum can make any surgery in the abdominal cavity that much more difficult. I know that obese patients are more difficult to move, position and lift than normal-weight patients. I know there are other physiological problems associated with obesity that make make patient outcomes less successful. All that said, it's the surgeon's job to treat the patient as he or she is, not how the surgeon wants him or her to be. If that means adjusting to a more obese population, so be it. If that means planning ahead for the difficulties of surgeries on obese patients, so be it.

However, finding a vein should not usually be one of those problems. Even an associates' degree level phlebotomist knows you find veins by feel, NOT by looking. If you go by feel, you get a good, plump vein that isn't nearly as likely to collapse. A surgeon should know this.

Skeptical Scalpel said...

Anon, relatively speaking, fat is not really well vascularized. Who said anything about finding a vein?

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