Dr. Chris Thompson does not need any introduction, very well known in the field of endoscopic and metabolic – bariatric endoscopy and metabolic therapy. He will talk to us today about maybe a case-based review of bariatric endoscopy. Chris, thanks for taking the time to be with us this weekend, and welcome. Thank you so much. Good to see you. All right. Thank you. So, just a quick show of hands, how many of you do bariatric endoscopy in your training right now? Are you exposed to it? So, a few people. Okay. Good. Hopefully, that will continue to grow. It is an epidemic. Like, over half the country has obesity, so hopefully, our GI divisions will start stepping up and helping out with that one. I work with all the companies, so I cancel each other out. Hopefully, I won't be biased, right? Is that good reasoning? I don't know. I hope it is. So, bariatric endoscopy has been around a long time, okay? The first intragastric balloon was in 1985, so way back, right? So, this is the Geron Edwards bubble. Now, it was shaped like a Coke can. It had some seams, so there was a lot of bleeding and perforations, so it didn't make it very long, but this was the beginnings of it. And then, we started doing suturing for revision of failed gastric bypass and different complications. In 2003, and then in 2012, we did the first ESGs, and then we were off to the races. So, now we think of these procedures kind of into two broad categories, gastric devices and small bowel devices. So, the gastric devices include space occupying devices like intragastric balloons, gastric remodeling procedures such as ESG with suturing or placation with other platforms, and then other devices as well. And the small bowel devices, they include the sleeves, the liners, the resurfacing procedures, and none of those are FDA approved yet. Now, size, Dr. Girapino is going to be talking about suturing, so I'm going to be focusing more on balloons for this talk. So, there are three intragastric balloons that are currently approved by the FDA. The two you see there, the fluid-filled one on the left and on the right is a gas-filled one, and there's another one that's adjustable, so if someone's feeling sick to their stomach and nauseous, you can take a little fluid out. If they're not losing enough weight, you can put more fluid in. So, those are the two fluid-filled ones are commercially available. The gas-filled one is now currently off the market, but it might come back. The original indications are listed there, class one obesity and class two obesity. Class one requires a comorbidity. That is now changed with some guidelines and recommendations we'll talk about. Contraindications are any prior gastric surgery, even a nissen fundoplication, anything like that will lead to bad complications. So, don't take the patient's word for it. They want the procedure. Look on their abdomen for scars. If they've had gastric surgery, you cannot do a placement of a balloon. And large hernias is also a contraindication. Other balloon on the cusp is the ellipse. This balloon, actually, you swallow it and then it passes on its own. That's an FDA trial, hopefully be cleared soon. There's another device called the transpyloric shuttle that was approved, kind of designed to cause intermittent gastric outlet obstruction, and that was approved but not commercialized yet. Back to this guideline. This was first authored by Dr. Giropino and a lot of the people from the ASGE ABE committee were on this. You can see that they recommend a different kind of weight category for these treatments. They basically suggest the use of EBMTs, including intragastric balloons, plus lifestyle modification over lifestyle modification alone for any BMI over 30 or BMIs of 27 to 27.9 with one obesity-related comorbidity, so that's the new cutoff. What about weight loss with intragastric balloons? You get about 11.27% in this meta-analysis, and that holds across all weight categories, class one, two, and three. Comorbidity resolution also seems to be pretty decent. This is a meta-analysis, 10 RCTs, 30 observational studies, over 5,000 patients, and they found an average decrease in HbA1c of 0.6%, and if you looked at pre-diabetics, it dropped by 1.1%. Improvement in other comorbidities as well, hypertension, dyslipidemia, LFTs improved, et cetera. The SCE rate in this meta-analysis is 1.3%, lower than other meta-analysis, but it did show five gastric perforations and two deaths with a metabolity rate of 0.04%, and that's because these were placed in people that had prior surgery, so you must avoid putting this in surgery. That's a definite way to lose a lawsuit and hurt a patient. SCE rate from the different meta-analysis here shows about a 5.6% rate, and you can see the list here, perforation 0.3%, hemorrhage 0.76%, dehydration, severe dehydration, that's something to worry about with electrolyte disturbances. That's where you're going to get in trouble, 0.7% bowel obstruction and aspiration pneumonia. FDA, after approval, released this. There's two other things they weren't aware of, weren't in the meta-analysis, overinflation or hyperinflation, and acute pancreatitis, both less than 1% but with dire consequences. We'll talk about these as we get into the case-based portion of the discussion. A couple more slides here. How do these work? It was thought they were space-occupying. They fill the stomach, so you eat and you get full quick, but this was a great study out of Mayo. It was a randomized controlled trial looking at 29 subjects. You can see here, this is gastric retention. The blue is the treatment group and the red is the control group, and they put the balloon in at this point in time, and then you can see retention is markedly kind of prolonged here in the treatment group while the balloon's in place. They take the balloon out and it goes back to normal. That shed light on the mechanism of action of the balloon. Next, delaying gastric emptying, which now has led us to design new procedures, such as the BEAM procedure, which is an anteromyotomy, a pylori-sparing anteromyotomy, to induce weight loss. They're using third space techniques for weight loss now, and we're designing different suturing patterns to augment the delay in emptying to get that weight loss. What about long-term durability of the weight loss following balloons? Well, it's really not there. This is a study of 500 patients with five-year follow-up, and of the people that responded to the balloon initially, only 20% maintain a 20% excess weight loss at five years. So not good durability, you need a long-term game plan in place if you're going to use a balloon. Convert them to suturing, have some other plan to keep that weight off, because the balloon itself usually won't do it. Back to the guideline here, you can see that the ASG-ESG suggests the use of intergastric balloon plus lifestyle modification over lifestyle modification alone, that's conditional with moderate quality of evidence. They also suggest the use of paraprocedural antiemetics, pain meds, and PPIs for the duration of balloon placement. All right, so now with that as background, we're getting into our cases. This is a patient, 39-year-old female, with a history of balloon placement three months prior. She has abdominal pain, nausea, and emesis. All right, now that's normal right after the balloon goes in, but not three months later. The abdomen is distended, looks like she responded pretty well with 11% total weight loss, no other comorbidities. So what's the next step? Imaging. Okay, what would you do? Oh, you jump right to a seat, that's pretty good. You must work in the emergency department in moonlighting, but we start with, I like the CT though, we're going to get there. So we start with this image. You kind of see the balloon there, right? This is usually what they'll do first. And I don't know if you're seeing anything there that would indicate something's wrong. I'm not. It looks like it's okay, but this shows the importance of also doing upright, right? So upright image here, and you can see this. So when you first see this, I don't know what you're thinking. Any ideas? What's that? It's hyperinflation. Hyperinflation, that indeed is hyperinflation. This is the seat that we got around to that CT scan. You can see it right there, right? And so hyperinflation. So you always need to get an upright abdomen and chest or get a CT scan because you need to make this diagnosis and you have to go take it out. So the idea is the balloon itself is infected with a gas forming organism and it's just going to keep expanding until the stomach perforates. So you need to get it out. This is a standard removal kit. You basically have a needle that you advance into the balloon. You tend to kind of suction the stomach down around it to keep it stable so it doesn't slide around. And you want to keep pulling that fluid out until you see crisp edges. It's almost there. That's what you want to see. Then it's safe to come out. Otherwise, as you pull it up and out through the esophagus, the fluid will pool in the bottom of it and can tear the esophagus pretty dramatically. And then there's a little tripod and rasp that you use to remove it. So some points on this typical removal. We're looking to see if there's any ulcerations there as well. You have to remove this. It's essential, but you also need to do it while the patient is intubated under general anesthesia. A lot of these people will have retained, again, the mechanism of action we talked about is delaying gastric emptying. So it's natural for them to have food in there. So you want to make sure you protect the airway. And always fully evacuate the balloon before removal. So this looks like the same situation, but there's something different. I'm not sure if you can notice what's different in this. You still see air fluid. It is. I like it. Look at that. You have that little tail right in there. And that tells you it's a spats balloon, which is great because now you don't have to remove it, right? You can actually just pull out all the fluid and replace it with bacitration. You can actually retain the balloon and help them to continue losing weight. So it's nice. That's one advantage this adjustable balloon does have. One more imaging study here in the importance of an upright. You notice what's going on there. That one's pretty obvious. Anyone? Right. Yeah, that's perforation, right? This is, you have to be very careful with these. So you can't go in and take this out. I love suturing. I do a lot of suturing. I'm not going to try to suture that close. I'm not going to take the balloon out and then try to suture it because usually there's a large area of the stomach wall that's kind of ischemic, okay, and even necrotic and it's very dangerous to go in there. So I wouldn't even go take the balloon out until laparoscopes are in and we're ready to go. And then you can take it out endoscopically if they want. Sometimes they'll just cut the stomach and take it out themselves. Second case. So a 42-year-old female, history of balloon placement, two months prior to presentation with abdominal pain, nausea, and vomiting, abdomen is distended. You can see there the BMI, no comorbidities. So what do we notice here? Really important to know how to read. What's that? Yeah, it is. They didn't really respond. It's only a couple of months. It is, yeah. It's weird, right? The balloon is supposed to be over here and instead it looks like it's over here maybe, right? I don't know if it's duodenum, but it's not in the right spot, CT scan, right? So we did this imaging study here too. It looks like we have a little bit of an air fluid level down here, but not much, CT scan. So it's impacted in the antrum. And that's why we also don't have any really air in the stomach. Not much at all, right? It's just full of fluid and food and whatnot. So it's important to do an NG2 decompression. This is why we don't just want to run in and do endoscopies in these patients. This would be very unsafe to go in. The airway certainly would be at risk even with intubation because that is really distended with a bunch of fluid and food. So low threshold for cross-sectional imaging, as was mentioned on the very first case. So what we did here was we NG2 for decompression, going under general anesthesia. We confirmed this was impacting the antrum, causing obstruction, and the balloon was successfully removed. Another one, 48-year-old female history of balloon, seven months prior. So it's a little long. It's supposed to be in for six months, right? It's a little pain, nausea, emesis, abdomen is distended, 15% total weight loss. That's great. And this is different imaging now. What do we see in here? What's that? Ileus? Yeah, a lot of the small bowel is distended, right? Where's the balloon? I don't know. Yeah, maybe, right? Should we get a CT? Yeah, now we got the small bowel. That's right. It started leaking and it migrated down the small bowel and caused some problems. So balloon migration, small bowel obstruction, and this required surgical resection of the bowels. It was necrotic. So this is a good time to say, I think balloons are far more invasive than suturing, right? Patients come in wanting balloons because they're the safest, they can be removed. You don't see this stuff with suturing, right? Suturing in my opinion is much safer and I prefer it. I try to convince patients of that. Plus, it's more durable. You know, with balloons, we saw the weight comes back on. It's like a medicine sort of, you stop it and the weight comes back on. So not a big fan, but I do do them and we can talk about why. Bridges, you know, someone's getting a transplant and they need to lose weight. Someone is super obese and needs to lose weight to be down to an area where they can actually have a surgery safely. Knee surgery, something where it's a bridge to something that will allow them to maintain the weight loss after they get it off. So some other things you can see, looks like a microperf here, another good reason to get a CT scan. And here we have pancreatitis, right? So you can see all these things. So low threshold for cross-sectional imaging. Case number four, 27-year-old male, new onset of green urine, two months after intragastric balloon placement. No abdominal pain or distention, they feel fine. Methylene blue, right? So wow, is this in the small bowel like the last one? Well, they're not having symptoms. Did it pass? No. What's going on? Well, you need to know where it is because you can't just leave it in there and take the chance it's going to migrate and cause a bowel obstruction, right? So you do an imaging study, you just first do an x-ray. Looks like it's in the right spot. I don't know. It's in the stomach, so you go take it out. But you have to take it out differently. So with balloons, normally you just put a needle in and you can generate negative pressure, but this already has a hole in it. So you're not going to be able to fully evacuate it. And it's tempting to do it, but you can't fully evacuate it if it's already leaking. So what I recommend doing is you can take out a lot of the fluid with the needle, but then there's always going to be some residual because you can't get the negative pressure. So you have to get on with a double-channel scope and a rat-toothed grasper, cut into it, drive into the balloon, and evacuate the fluid. Otherwise, you really are putting the patient at risk of a bad esophageal tear. And also, if you didn't put the balloon in, this is one from South America, this is a double balloon. So there's another membrane inside the outer membrane. I would never have fully evacuated this. So it's important to go in and confirm removal of all the fluid. And one last point here. A lot of patients, especially in warmer climates, will have this. Anyone know what this is? It's fungus growing on the balloon. It's disgusting, actually. And you don't want to pull this out. You can infect the patient, actually, especially if it's traumatic on the way out, but it's not pleasant for the whole room, too. So what we do is we make sure they start Diet Coke a couple days before that removal, and it'll clean up the balloon, come out squeaky clean. So with that, some summary thoughts. Imaging is critical when you're dealing with balloons in patients with symptoms. Upright abdomen, cross-sectional studies are paramount. You need to know where that balloon is so you can treat it appropriately. Don't rush into endoscopy. You're looking for all sorts of things like perforation and where it is. Again, confirm the location. Look for air. Look for hyperinflation. And always do your endoscopies for removal under anesthesia. Placement you can do under MAC, but removal has to be under anesthesia. And completely empty that balloon before you pull it out so you don't traumatize the esophagus. And that's it. Thank you very much. Any questions? Hey there. How do I... Oh, okay. Can you hear me? Okay. Quick question about the hyperinflation. Does that usually occur on the time when they put in the balloon, or can it also occur afterwards? That's a good question. Right? Because if you can put in the balloon, you can put in the balloon. You can put in the balloon. You can see this at any time, which is interesting. I've seen this a few times and some, one of them was right away, which was surprising. And then the other ones were not my balloons, they were replaced by other people. And they were quite delayed, right? Like one was like been in way too long, almost been a year that things should have come out. But it's kind of interesting. So we don't know exactly the mechanism. I think that mine probably was contaminated around the time of placement, right? And I think the others, and maybe they're getting in through, maybe it becomes more porous with time. The thing had been in over a year in the one case. So obviously the gas forming organisms are the problem. I was uncomfortable with the idea of the SPATs balloon, just taking the fluid out and then replacing it with basset tracing, but that seems to work. And there's no reports of recurrent hyperinflation in those situations. So it's unclear exactly what the mechanism is, but we're seeing more of it, something to be mindful of and definitely take it out if it's not an adjustable one. Thank you. With an adjustable balloon like the SPATs, is there a minimum volume that you found that if you go below that, they're more likely to migrate? Yeah, I tend not to take, I think that's a good question. I think you still need to keep a minimum amount of fluid in there, whether that's 500, we don't really know. I don't think anyone's really tested out how low you can go and how safe it is, especially with SPATs, because the thing that makes it, adjustable also makes it more dangerous for migration. That tail actually you'll find with those balloons, they tend to be pulled down the duodenum. So it's not uncommon when you go look for it, look at a SPATs balloon, even just to take it out routinely, spend six months you're taking it out. The thing is down in the antrum, sort of like the transpyloric shuttle, right? So I'm scared to take out too much fluid in those, but generally people just, they'll take out 100 CCs and see if it helps, but mostly they're going up on it. I don't think I've ever gone down because of symptoms. Those accommodative symptoms, usually you can get them through, it's kind of interesting, right? The accommodative symptoms, you usually get them through that within a few days. And then the patients that don't get through it, they're so sick, they just want the balloon out. They're like, I don't want to adjust it, I want it out. So it's like, I've never actually done much down adjusting, but it's been done in the literature, yeah. So typically it's like in the first video where I showed we're using needle and then you can actually use an EOS needle as well right and then you advance it in and you want to retract the needle you advance it into the sheath and then you pull out the fluid. It's important to remain perfectly still when you're doing this because it's easy for the the balloon to move around you can lose kind of needle access and then you're in the situation where you do have to use a scissors and cut and make sure everything's out of there. But typically you can do it with just a needle. So you go down with they have a kit that does it very nicely. You advance the needle in a little catheter follows the needle. We even sometimes just suction down the stomach turn off the monitor so you're not tempted to try to make any adjustments and then you record how much went was in the balloon you put it in and then you make sure you take out the same amount of fluid. Turn the monitor back on and confirm it's flat and disc shaped and then you can you can remove it safely with a they have a like a little special grasper for it. If you don't have that grasper you can use an EOS needle and then a rat tooth forcep through a snare and you grab it and pull it into the snare and then you can pull it out safely that way. But the most important thing is it's got to be all the fluids got to be out of there because even if you cutting corners there is very dangerous that the the areas where you see problems is number one putting in some of the prior surgery they're gonna perforate and have and have a really bad outcome. Number two electrolyte problems early on during the accommodative symptoms when people are vomiting and you don't pay enough attention to them they can get very dehydrated and have some problems there. And number three is on removal and that's where we've seen some complications in the United States where in particular is inexperienced endoscopist a lot of times as surgeons you know plastic surgeons do these now a lot of people are doing these that don't do a lot of endoscopy. They'll just stick the needle in think they get enough fluid out it looks pretty decent then they'll try to pull it out to be a little aggressive and they'll they'll perforate up at the piriform sinus or something like that and it's problematic. So those are the three big things to worry about where you can hurt patients in addition to the the cases we discussed. All right thank you. Can I ask you one question? Sure. So I think this is relevant to you guys because you've done more of these than anyone I know and where do you see the trend in over the last 10 years I know we've seen the advent of a lot of restrictive therapies now small bowel options where is that going for someone come out of fellowship is this worthwhile to learn and become very well versed at or should they invest their time elsewhere I know you alluded to that by talking a little bit about ESG and and I think in the US we're kind of recalibrating on balloons a little bit at this point and thinking what's more bang for the buck and worthy of our time. That's a great question so balloons himself I think that the endoscopically placed balloons will probably be replaced by the swallowable balloon that will pass on its own but there's gonna be a lot of those used and we're gonna deal with the same complications there's gonna be the same complications so I think it's really important to understand the balloon complications how to manage them just as an advanced endoscopist because they will come to your hospital it's so funny there's not a lot of bariatrics done elsewhere in Boston so we will get hot we'll get patients sent to us from the other major academic institutions because a balloon they don't know how to deal with it that's not good right I think all advanced endoscopists should know how to deal with a balloon it's a foreign body and there are some nuances to it but I think we all have to learn how to deal with it and I think they will be around these these swallowable ones procedure lists they call them I think they will be around and I think they'll be used a great deal what procedures do I think we'll be doing for weight loss I think it'd be very different right so we're doing a lot of ESG's right now it's better than surgery in many ways I'd rather have you know if my parent was gonna have a weight loss procedure I'd rather have an endoscopic one an ESG rather than a sleep gastrectomy for a bunch of reasons right and the procedures are getting better and better right so now we have a robotic one we're doing where you're sitting it like a da Vinci robot and doing it and it's faster so I'm doing eight of these in a day my hands are killing me at the end of the day it's horrible right but sit down do it at a robot council beautiful it's gonna hopefully also make it some more people can do it well so poem I love doing third space procedures okay I have a day a week I do third space procedures in my opinion is much easier learning poem G poem than it is for to do suturing well to do suturing well takes a volume takes time very difficult I think so I think robotics will level the playing field and help that out but there are other procedures on the way to we mentioned small bowel that's fascinating because of the metabolic effects you can have and now the more recent thing that we're working on and we're gonna go into clinical trials I think in the next year's gene therapy we're injecting adeno associated viruses into the tail of the pancreas so the beta cells produce their own glp1 so now instead of giving yourself an injection every week you get one for your entire life it is having phenomenal results in animal models just imagine that right you can do gene therapy us-directed gene therapy it's very exciting so I think we're gonna be managing obesity as gastroenterologists in particular as therapeutic endoscopist by a variety of different procedures it's very exciting time to get involved in it so hopefully hopefully we'll get more and more exposure and our divisions would be more interested in taking it on soon fantastic thank you Chris thank you

bariatric endoscopy

intragastric balloons

obesity management

procedural complications

emerging technologies

gastroenterologist training