Vladimir Kushnir M.D., a bariatric endoscopic surgeon at Washington University in St. Louis, talks about a newly-approved weight loss procedure that can help when diet and exercise is not enough.
Interview conducted by Ivanhoe Broadcast News in January 2017.
I want to ask you a little bit about the Aspire, if you could explain what it is and what it does?
Dr. Kushnir: Aspiration therapy is probably the most controversial of endoscopic weight loss procedures. Endoscopic weight loss procedures are new and the demand for the endoscopic weight loss procedures exist because while weight loss surgery is very effective it also comes with a significant amount of time off work. It’s invasive and can have serious complications and also requires permanent alterations in the gastrointestinal tract. Endoscopic weight loss procedures fit in between surgery and medical weight management in that they’re lower risk then surgery. And don’t involve permanent alterations to the body although do typically involve a procedure that requires sedation and result in weight loss. The weight loss for most endoscopic procedures is less than what seen with surgery but significantly more than what’s seen with diet and exercise alone.
So again, it’s the middle, it’s almost the middle of the road?
Dr. Kushnir: It’s trying to bridge the most invasive with the least invasive and get as much of the efficacy with as little of the risk as possible.
Who’s a good candidate for something like that?
Dr. Kushnir: For aspiration therapy currently it’s FDA approved for folks who have a body mass index between thirty five and forty five and, and don’t have any major medical co-morbidities. Such as have not had major surgery to the stomach, has not had prior weight loss surgery and really need to lose the weight and haven’t been able to do it with diet and exercise alone.
Talk to me about what it is, what you technically have to do so that our viewers can get an idea.
Dr. Kushnir: Aspiration therapy is an endoscopic procedure for placement of the device. What the device is a modified feeding tube with a larger internal portion and a small external portion. What patients do after the device is implanted basically after about thirty minutes after eating they aspirate about a third of the food that they ate and dispose of it so it doesn’t get absorbed. Similar to what happens with weight loss surgery some of the food that you eat just doesn’t go where it naturally would which helps you to lose weight because you don’t absorbed quite as many of the calories.
Could you describe the procedure that patients have to do?
Dr. Kushnir: What patients do is go to a restroom or another private place and then connect the external portion of the device to a water canister that that creates the vacuum and then you pump water into the stomach and pull a little switch and then evacuate the contents of the stomach into the restroom. Typically they do that a few times after each meal and usually after the larger meals two or three times a day.
You said about a third, how can they tell when to stop?
Dr. Kushnir: When to stop? That’s a very good question. Typically patients aspirate do repeat cycles if irrigation and aspiration until they either don’t get much more out or it doesn’t look like there’s much coming out other than the water that they’re putting in.
Is there an estimate on how many calories per treatment or per time you aspirate a patients getting rid of?
Dr. Kushnir: That all depends on what you’re taking in. For example, you know if you have an ice cream sundae the amount of calories you remove is going to be proportionate to how many you took in. Again we aim for about a third of the volume of the meal that was taken in. Now aspiration therapy does not work on its own. You have to combine it with number one, diet alterations and number two, lifestyle change. What we found is that patients who are doing aspiration therapy, who’ve been most successful with it, first and foremost watch their calories. They also plan their meals more because you have to be prepared to aspirate about a half-hour after you eat. You have to know where you’re going to eat you have to also modify your diet. Certain foods don’t work well for aspiration for example, foods with a lot of fiber. If you have a salad, that’s much more difficult to digest. Once you’ve aspirated you also have to chew food up really quick and you have to drink a lot of water, again to help the stomach with the digestive processes as much as possible so you can be most effective at aspirating.
If you don’t do that, if you don’t chew what happens?
Dr. Kushnir: It’s not going to be effective because the stomach usually takes at least one to four hours to kind of grind food up into the consistency of sand. It can pass through the digestive tract and also so that it can be aspirated. If you don’t drink a lot of water, if you don’t chew really thoroughly, then it’s not going to work very well. What we found is folks who again have been most successful with aspiration therapy, the time it takes them to eat a meal extends significantly. Again, a lot of it is just behavior change and much more mindful eating. Also patients who are doing aspiration therapy have a lot less dread. Everyone’s been on a diet and when you’re on a diet and then all of a sudden you have one minor indiscretion, you go out to dinner and you have a piece of cake. For a lot of people who are trying to lose weight that’s very discouraging and they go home and they say, well why I am on a diet in the first place. For folks who are doing aspiration therapy I think it gives them a feeling that they have a little more control over what they take in and what their body absorbs and gives them a little more encouragement and that extra motivation to stick with it.
What about weight loss in terms of numbers? What can the patient expect and how quickly does the weight start to come off?
Dr. Kushnir: The weight starts to come off fairly quickly. What I can say is from the US clinical trial that led to the approval of the device folks lost about fourteen percent total body weight. That’s comparable to what’s seen with some of the less invasive surgery such as the lap band.
How does this compare, a lot of people heard about balloons or gastric bypass or banding of the stomach. How does this procedure compared to that?
Dr. Kushnir: Gastric bypasses is by far the most effective procedure as far as weight loss. It also is perhaps the most invasive. With Gastric bypass about thirty five percent total body weight loss is what you see on average.
About how much weight can people expect to lose?
Dr. Kushnir: With aspiration therapy in the US clinical trials fourteen percent is what was seen at a year. That’s total body weight loss. Some of the European studies that were done a little earlier up to twenty percent total body weight loss was seen, which is really fairly impressive. Twenty percent total body weight loss is what you see with some surgical procedures such as a lap band.
What about risk factors? What are the risk factors for doing this?
Dr. Kushnir: Any procedure can have complications. The initial placement of the tube how it carries the risk of complication and the main one being a bowel perforation, infection and bleeding in US clinical trial there were no serious complications that required surgery. I believe one patient required overnight hospital admission for pain related to the tube placement. But most folks do have at least some discomfort of the tube site because you do have a hole and we are making an opening in the abdomen where there isn’t one. The abdominal wall muscle and soft tissue aren’t comfortable. That usually gets better within the first five to seven days after that issues do come up with some irritation.
I hate to stop you, you were talking about after the surgery.
Dr. Kushnir: After folks recover from initial placement there can be issues with local irritation with the skin or local infections of the skin in most of where the tube comes out. Most of those can be dealt with, with either oral antibiotics or just topical treatment and don’t require major interventions.
Are there any patients for whom this is not a good idea?
Dr. Kushnir: Patients who have had prior weight loss surgery or prior surgery on the stomach this is not a good idea for it. Because the devices are designed to fit in the normal stomach and if somebody has had their gastrointestinal tract altered it can cause complications. The device is simply not designed for it. Additionally folks with a history of eating disorders, it would be a contraindication.
Why is that?
Dr. Kushnir: Any kind of weight loss procedure really is contraindicated; even weight loss surgery is contraindicated with somebody with an untreated eating disorder because it can certainly make people think that it’s okay to binge, same thing with bariatric surgery or intragastic balloon. If somebody does have a history of an eating disorder, other uncontrolled psychiatric illnesses those have to be treated and controlled under the care of a psychiatrist before someone can be considered for aspiration therapy or any other weight loss procedure.
Is it reversible?
Dr. Kushnir: Yes, it’s completely reversible. The current design of the device it has to be removed endoscopically, meaning an outpatient procedure where basically the patient goes to sleep and we use a flexible endoscope to remove it. Then the opening in the skin typically closes off in the first five to seven days.
One of things that I know our viewers will sit there and think about is bathroom habits. Anything change, everything still works?
Dr. Kushnir: Typically nothing changes. Again when compared to things like weight loss surgery which certainly can lead to issues with stomach regularity and things like that aspiration therapy really doesn’t affect the way that the rest of the digestive tract functions. You just simply put less food in than you would otherwise.
How do you beyond the ick factor?
Dr. Kushnir: Certainly this procedure elicits a fairly strong reaction from folks initially. What I can say is like any weight loss intervention this is designed to help people, empower people to feel that they can lose weight number one. Number two, like all the other weight loss procedures we do it’s designed to make that folks absorbed less food than they would otherwise or take in less food than they would otherwise. Number three it’s very effective leading to weight loss and it is reversible. The effective weight loss and reversibility of it are really the attractive parts of it.
Would you say that for some folks who have not been able to lose weight that this is life-saving in some cases?
Dr. Kushnir: It certainly could be. Obesity is a very serious disease and the rising costs of serious medical problems. For example, fatty liver disease is on pace to become the number one cause of the liver failure and need for liver transplantation. We see patients all the time in our liver transplant clinic who desperately need a transplant because they have cirrhosis from fatty liver disease but they don’t qualify for a transplant because they’re too overweight. In somebody for example, who has fatty liver disease and on the way to developing diabetes, developing liver failure and other complications, weight loss from aspiration therapy or any way bariatric procedure can be life altering and lifesaving.
How new is the surgery and how many of these has made it in comparison with the gastric bypass, which is commonly done?
Dr. Kushnir: This is very new. The device was FDA approved in the United States over the summer and outside of clinical trials we’re just starting on doing this procedure. Part of clinical trials in the US and Europe I think over five hundred procedures have been done and more have been done since It’s come out. But certainly this is kind of a new kid on the block. Now the technology that it’s based on is over thirty years old. The procedural part of placing the aspiration tube and removing the aspiration tube has been done millions of times.
Like a feeding?
Dr. Kushnir: Exactly the procedure is the same has placing a feeding tube.
What is the success rate?
Dr. Kushnir: Success rate in placing the aspiration tube is over ninety-eight percent.
Success rate in your patients losing weight?
Dr. Kushnir: I can tell you what happened in the US clinical trials since we’re only getting started doing this clinically. I can tell you that over sixty percent of patients lost more than ten percent of their total body weight, which is a very good result. It compares very favorably with other endoscopic weight loss procedure such as intragastric balloon.
Is there anything I didn’t ask you that you think people should know about this?
Dr. Kushnir: No. Once you get over that initial ick factor and that’s the term I actually use during information sessions. Once you get over the initial ick factor it is a very effective reversible procedure for weight loss. A lot of people say, well everyone’s going to know that I do it. But I think as you can see in the video with Eric really it’s a very discreet very small device and no one other than you and your intimate partner and your physician will know it’s there unless you want them to.
Tell me about a click that you can adjust for the clicking?
Dr. Kushnir: In order to make sure that folks are following up with a physician regularly and also that everything works correctly the external port clicks I think a hundred and fifty seven times, don’t quote me on the number of times that it clicks. It clicks a certain number times and each connection is a click. So once you’ve run out of clicks you have to see your doctor to make sure the tube is working fine and get a new skin port adapter so that you can continue aspirating.
END OF INTERVIEW
This information is intended for additional research purposes only. It is not to be used as a prescription or advice from Ivanhoe Broadcast News, Inc. or any medical professional interviewed. Ivanhoe Broadcast News, Inc. assumes no responsibility for the depth or accuracy of physician statements. Procedures or medicines apply to different people and medical factors; always consult your physician on medical matters.
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