Monday, June 20, 2016

The Aspire Assist: Surgical Bulimia Or A Case Study In Weight Bias?

I can't tell you how many people have contacted me about the Aspire Assist. What's been genuinely shocking to me is that the sentiment surrounding the online commentary, as well as the emails I'm receiving, is hugely reflective of weight bias - including from colleagues who I know are champions in the fight against weight related stigma. I wrote this post when the Aspire Assist was first launched, and I'm updating and reposting it in the hopes of triggering at least a little bit of reflection.
Is this new device simply a condemnable medical bulimia machine?

That's certainly the tenor of the discussion out there as generally the reports on this are either pretty angry or simply express revulsion.

Superficially it really does sound horrifying, and undeniably, at first blush it's not what I would consider to be the intervention I'd always hoped for. But when researching the story of course I needed to know - what type of studies have been done on it to date?

Believe it or not, their very early data's interesting. Now this isn't peer reviewed published data, just a presentation, but in it they describe the 111 patients who were randomized to receive an Aspire Assist. 74% of them completed the year long study (vs. only 50% of the control group who received the same lifestyle counselling as the Aspire Assist group but no Aspire Assist).

The results were dramatic. This 15 minute long outpatient endoscopic procedure led completers to lose nearly 40lbs on average representing a loss of 15% of their presenting weights. The completers of the control group meanwhile lost on average just 4lbs.

Not surprisingly, there were post-operative adverse effects - the most common being irritation or granulation of the stoma (the exit port). There were only 4 subjects who reported "serious" adverse effects and all were quickly resolved.

Eating behaviours were also monitored. Pre-surgically subjects were screened for binge-eating, bulimia, and night eating syndrome. None of the Aspire Assist patients were reported to experience worsened eating behaviours, while one control subject developed bulimia.

Interestingly, self-reported data actually demonstrated improvements in Aspire Assist subjects' eating behaviours with more thorough chewing, more water consumption greater meal planning, more mindful eating, and decreased calorie consumption (confirmed by the fact that losses were greater than would be predicted by simple aspiration).

And as far as tolerability goes, the vast majority reported satisfaction with the device, with 93% of survey respondents reporting that they would be somewhat or very likely to recommend it to others.

Comparing the Aspire Assist to the other endoscopic bariatric procedure, the intra-gastric balloon (a procedure that has not been raked over society's coals) the Aspire Assist appears to lead to markedly larger losses with greater response rates and fewer serious adverse effects.

So yes, back to the shock, horror and repulsion, while I readily agree that on its surface both the premise and procedure is less than appetizing, I'm pretty sure that safety and efficacy, not grossness, are what determine the utility of an intervention. If larger, longer, studies reproduce these results whereby the Aspire Assist doesn't lead to or exacerbate disordered eating, involves minimal risk, has minimal adverse metabolic or nutritional consequences, and leads to sustained losses which in turn had demonstrable medical or quality of life benefits, why wouldn't I consider it?

As I've written before it'd be wonderful if everyone lived incredibly healthful lifestyles and in turn those incredibly healthful lifestyles guaranteed weight loss (they don't BTW), but I think my job as a physician is to ensure people are equipped to make informed decisions, not to make decisions for them, or to judge the ones that they make. If the Aspire Assist proves to be both safe and efficacious in the long run, I'll happily discuss its pros and cons with each and every suitable patient. I'll also happily discuss more traditional bariatric surgery, pharmacotherapy, purely behavioural therapy and also the option of doing absolutely nothing with them. And I'll do it all in a nonjudgmental manner too - because my job is to ensure my patients are aware of the risks and benefits of all of their treatment options, including watchful waiting, and then to support them in whatever informed decision they make. To do otherwise in my mind is contrary to the spirit of medicine and suggests one of two exceedingly common and unfair weight biases. First the one that often angrily asserts that unless a person is willing to make formative lifestyle changes, they're not worthy of being helped, or the second - that if only patients wanted it badly enough, they'd just fix themselves. Honestly, if desire were sufficient is there anyone out there who'd struggle with anything?

So is the Aspire Assist brilliant or brutal? Given it's just been born, it's going to be at least a decade before we'll even have the chance of having the robust long term data to make an informed decision. Until then all I can really say is that I'm looking forward to reading it.