Hello, everyone, and welcome to this webinar on endoscopic sleeve gastroplasty presented by the Association for Bariatric Endoscopy. My name is Marty Roth, and I will be your moderator for this program. Before we get started, I have a few housekeeping items. There will be a question and answer session at the close of the presentation. Questions can be submitted at any time online by using the question section in the GoToWebinar dialog box on the right-hand side of your screen. If you do not see the GoToWebinar dialog box, please click the white arrow in the orange box located on the right side of your screen. Please note that this learning event is being recorded and will be posted in GILeap, ASGE's learning management platform. You will have ongoing access to the recording in GILeap as part of your registration. Our presenter for this webinar is Dr. Christopher Thompson. Dr. Thompson is the Director of Endoscopy at Brigham and Women's Hospital and Professor of Medicine at Harvard Medical School in Boston. He is also the Advanced Endoscopy Fellowship Program Director and is clinical faculty at Boston Children's Hospital and the Dana-Farber Cancer Institute. Dr. Thompson's clinical interests include endoscopic surgery as applied to foregut conditions, pancreatic obiliary disease, post-surgical complications, and bariatric endoscopy. His research in numerous patents, the development of new endoscopic procedures, and over 200 publications. Additionally, Dr. Thompson was awarded the Brigham and Women's Physician Organization Clinic Innovation Award in 2007 for developing and performing the first endoscopic suturing procedure to treat obesity. And finally, he was the founding chair for the Association of Bariatric Endoscopy. So at this time, I will turn the presentation over to Dr. Christopher Thompson. Thanks very much, Marty. It's a real pleasure to be able to give this webinar, and I'm glad everyone can join for this as a topic that's been important to me for many years, and I look forward to a vibrant discussion hopefully with this. So we'll start. The topic is endoscopic sleeve gastroplasty, but we'll go beyond what we think of as typical ESG. Here are my disclosures. I work with most of these companies in some capacity. So we'll start with a little background on bariatric surgery and bariatric endoscopic suturing, and then we'll talk about the two kind of surgical analogs for what's being done with endoscopic suturing, the vertical band of gastroplasty and greater curvature imbrication procedure. So those are both surgical procedures that really, initially at least, people were trying to replicate endoscopically. And I think it really is persisting to this day. So there are, of course, many different types of surgery, and they're all fairly effective. You can see above here we have the gastric procedures, which really focus on reducing the volume of the stomach, either the sleeve gastrectomy on the upper left or the adjustable gastric band on the upper right. So they're creating a smaller stomach. And then below we have the procedures that also involve an element of bowel bypass. So you still in all of these have a partitioning or resection of part of the stomach, but you now have an element of bowel bypass, and that's thought to confer an additional metabolic component to the procedure, good for the treatment of diabetes and comorbidities. The Swedish Diabetes Subject Study is a longitudinal prospective match study. It wasn't a randomized controlled trial, but they had over 400 primary healthcare centers involved in 25 surgical departments, and they looked at several different surgical procedures longitudinally. So the circle here is banding, adjustable gastric banding. The triangle is vertical banded gastroplasty, and the square is gastric bypass. And you can see the gastric bypass, of course, is associated with the greatest percent total weight loss out to 20 years here, nearly 30%. But you see that even just those gastric procedures where they make the stomach volume smaller, either with the adjustable gastric band or the BBG, you get pretty decent weight loss out to 20 years, right? So that's very encouraging for our procedures, and then more in the 15 to 20% range there. So endoscopic, bariatric, and metabolic therapies, or EDMTs, really break down broadly into two categories, either gastric procedures or small bowel. The gastric procedures involve various devices. You have the space occupying devices, such as the intragastric balloons here. You have gastric remodeling, which is suturing or gastric placation procedures, aspiration therapy, and then a variety of other procedures as well. And those focus on treating obesity first and foremost. They're triggering weight loss. And then whatever other resolution you have in comorbidities is probably due to the weight loss. Then we have the small bowel procedures, and these have a more direct metabolic effects or anti-diabetic effects. And you can see there's various sleeves or liners, if you will, and anastomosis technologies, as well as dunaline mucosal resurfacing, where you're kind of ablating the mucosal lining of the duodenum. Now they all kind of have different proposed mechanisms of action, and some of these are really trying to mimic the surgical analogs. And that's really what a lot of the suturing procedures do, right? The small bowel devices are focusing on hindgut mechanisms, trying to splice GLP-1 and doing a variety of things there. The suturing procedures were thought to potentially delay gastric emptying and suppress ghrelins. That's one mechanism by which they can work. Or maybe they act like a sleeve gastrectomy, and they cause more rapid gastric emptying. And then you can also get into that scenario where you're spiking GLP-1 and triggering some of the hindgut mechanisms that you see with the small bowel devices. So one thing to keep in mind here with suturing and placating is that the devices, our FDA cleared, however, they don't have a specific weight loss claim. So they're an approved device, if you will, they're cleared through the FDA, but without that claim. So keep that in mind, unlike some of the other procedures or devices like a balloon that's actually specifically approved for weight loss. So a suturing has been available since 2000. This is when the first suturing device was approved in the United States. And it was really focusing on anti-reflux procedures. I became involved in the space in 2003, right after fellowship and started focusing on obesity. And we had a patent for this, and we did various procedures, including closing fistula, revising failed gastric bypasses, and some primary obesity therapy as well. And again, what we were looking at is the surgical alternatives that we could replicate. So we have the vertical banded gastroplasty here on the left of the DVG. That was kind of commonly performed for a while, and then was quickly replaced by adjustable gastric bands because it had a high failure rate due to staple line breakdown. So that was just a problem with the procedure, but it did work, provided that the staple line wouldn't break down and they didn't get complications like reflux. And then the other analog would be gastric imbrication, which was done more in South America, but there were some centers doing that in the United States as well, where they fold in that greater curvature of the stomach, again, reducing gastric volume. So these were the two targets for endoscopic suturing. And you can see here what a DVG looks like in an ex vivo stomach here. And so one of the first procedures that tried to replicate the vertical banded gastroplasty was the endoluminal vertical gastroplasty, and this was performed by Roberto Fogel. And you can see in the video, he's using one long running suture to do this. And he starts with one stitch kind of approximately, and then he goes distally and places a second one. And then he'll alternate anterior and posterior surfaces of the stomach, kind of marching all the way up. And he's going to do that to, again, partition off that kind of lesser curve, a little tunnel along the lesser curve. So he studied 64 patients, had 12 months of follow-up, and you can see here that the percent excess weight loss was 58.1% across the board, which isn't bad at 12 months, right? What was quite striking, though, is if you look at the BMI categories below that, patients with an initial BMI of less than 35 had an E5% excess weight loss. And people with a BMI of over 40 still had about a 48 to 49% excess weight loss there. Quite encouraging. Problem was that these results really couldn't be easily replicated. Other centers tried, but they weren't getting the same results. And there was also issues with durability of these sutures because it was a suction-based suturing device. It wasn't very permanent. Another procedure that looked at recreating the VBG was the TOGA procedure by Satiety. This is a stapler that was placed paraurally into the stomach, and then the stapler would open up and a sail would emerge from it to divide the stomach into the greater curve and the lesser curve. And then tissue is aspirated into the stapler from both anterior and posterior surfaces. And then the stapler closes and fires several of the staples there. And then it's repeated, and then they have a smaller stapler that narrows down the outlet. So what you're getting here, again, looks very much like a VBG. So they did this study in two international centers, one in Brussels, one in Mexico City. They studied 62 patients. The primary endpoint there was really safety, but the secondary endpoint was weight loss. And you can see there's a 24% excess weight loss at six months. And the problem, again, once you start stapling here is that partial staple line breakdowns were present in 13 of the 21 patients, and really the weight loss was scattered all over. And they got very close to really hitting that FDA endpoint, but then the company sold off the IP and they didn't really pursue it. And finally, the most current of these procedures, now this is an active device, and there's a report from Gotran Lopez-Nava from Madrid last year. And this was a single center prospective series of 13 patients using a device they call the EndoZip. And it looks very much like an overtube with a little bulb here. And you can see that the device kind of aspirates tissue into it, again, similar somewhat to that TOGA procedure, and you run suture through this. So in this particular study, they placed 2.6 sutures. Procedure time was 35 to 120 minutes. So it can be on the longer side, some of these, but again, they're on their learning curve. This is the first 13 patients they had done. And here you see the percent total weight loss is 12% at three months and 42% excess weight loss at that time period. So very encouraging early results. Again, the question with lesser curvature DBG analogs is durability. You know, the DBG wasn't terribly durable, you know, in many centers. So will this be? But keep in mind, the SOS study did show some good results for that for that DBG out to 20 years. So that might end up being a decent device. So now moving on to imbrication analogs, where we focus on the greater curve instead of the lesser curve. So this is some of our work. Myself together with Stacey Brethauer and Phil Schauer from the Cleveland Clinic, started doing these in the early 2000s. And we did our first human cases in 2008. And you can see again, we're imbricating or we're actually really running sutures along the greater curvature. And honestly, this this procedure, you see what it looks like afterwards. It's very much like the ESG, it was it was the similar suturing pattern to our first ESGs as well. We were again using a suction based suturing device. So that has implications for durability. Our first prospective series again, was in 2008, that we, we, we completed it. And we had, you know, 18 subjects, and you know, 14 finished in 12 months, and you can see the percent excess weight loss was 27.7%. So not horrible, good, good loss of waist circumference there as well. If you look at patients in lower BMI categories of 30 to 35, you had an excess weight loss of 30. So little more weight loss, you had improvement in blood pressure and in various other factors, including all the subjective measures as of 36, you know, vast hunger scores all improved. However, few placations remain intact one year. So and they were all disrupted in five of those patients and partially disrupted in another eight. So again, problem was, we weren't placing the stitches deep enough, clearly a good efficacy signal early on. Well, then, we finally got a full thickness suturing device. And, and this device, you know, really is not suction based, you're grabbing tissue with the helical grasp and pulling into the device, allowing you to place those stitches well into the muscle layer and full thickness, in fact, and this allowed also a variety of suture patterns, you could do running, interrupted purse strings, mattress sutures, whatever you whatever you needed. And all of a sudden, it opened up, really almost a whole new field, we could do pretty much anything we get over so ulcers, we could over so you know, GI bleeds, we could potentially do anti reflux procedures, you know, close perforations officially, but of course, it's going to be applied to bariatric purposes like reducing outlets and, and performing ESG. So here's what the device looks like many of you are probably familiar with it, you grab tissue activating handle to drive that needle through the tissue, pick it up on the other side, you're going to close the device to reload it. And you're going to repeat that process by grabbing tissue and driving the needle through again. And this is what it looks like clinically, we grab the tissue drive the needle through it, pick it up, open the device back up, reload the device by closing that handle again. And then we're going to lower the needle back down to that suturing arm and repeat. So suturing pattern that was originally used for ESG is similar to that one I just showed you it's sort of two triangular stitches. So anterior place greater curve, and then posterior and then you repeat and, and then you're going to essentially together and what this does theoretically is, you know, it is opposing anterior and posterior surface of the stomach, but it's also shortening the length of the stomach. That's why we did the two triangles. The second one that distance between the first triangle and the second one was when you cinched it pulling the stomach, you know, longitudinally to shorten the length of the stomach. So we did the first in human ESGs in 2012, myself, Rob Hawes and a small team and we went over to India to do these and the video is just showing the same pattern there. And we did four patients in the original first in man pilot placed 11 to 12 sutures up to 56 bites or stitch placements, BMI fell pretty substantially there from 37.4 to 34.8 over five months. So we didn't have any significant adverse events and we started doing pediatric cases in May of that year in the United States and they didn't go as well as they grew. There was kind of, it was kind of interesting, but you know, it was early on in the experience and there's been better results more recently. So we expanded that pilot to 126 patients across nine centers and this occurred between April of 2012 and May of 2014. And you can see the baseline demographics there and you know, BMI, average BMI was 36.2, not terribly heavy. And again, about 10 stitches placed on average, 10 sutures used, 54 stitches and duration of 94 minutes for these. And this is working with different teams. So we would always be there in these centers, whether it's Dominican Republic or Panama or wherever we work, but other doctors were learning the procedure along with us. And you can see here, one year, these patients had a drop in BMI from 36.2 to 29.8 and the total weight loss was 19.5% in one year. You presented our results in April of 2013 at Sages and there was some controversy there, but you know, there was still another procedure being done with the USGI device, which has now re-emerged and Santiago Horgan was doing a lot of that, that's I think on this list as well. And so it was a very active time for kind of very early clinical work in the space. Subsequently, Bar Mabadaya at Mayo Clinic was working on another pattern where he was doing many interrupted stitches. So he was placing several interrupted sutures. You can see here in the image that is from his, again, along the greater curvature, instead of running, he was doing interrupted. He found they were incredibly durable and he studied four subjects, 26 sutures were placed, took up to 245 minutes. The drawback was it took a lot of time, but it was very robust. And that's, I think, ultimately where we started modifying the procedure a little to do interrupted stitches inside the suture line as reinforcing sutures. And then we have, of course, the big study from the US, Reem Shariah. She studied 91 patients, a prospective series, and she followed them out to 24 months originally. And you can see here the percent total weight loss was 20.9% at 24 months. And that was a 66% follow-up rate. Many people weren't eligible yet. And she had one perigastric leak and a 1.1% SAE rate. So very encouraging. And what she looked at also is comorbidities and found that HbA1c improved substantially. In diabetics and pre-diabetics, it dropped a point, which is quite encouraging. And that's a good result there. Blood pressure improved, triglycerides, and liver tests as well. So clearly we're having some sort of metabolic effect. It might be secondary to weight loss. It might be due to something else. You then follow that up with our five-year outcomes. And 216 patients, you can see the baseline BMI is 39, so getting a little heavier here. And of these patients, let's see, we had 68 that were eligible for the five-year follow-up period. And you can see here that that's not a bad follow-up rate of 82% at the time. Efficacy of 15.9% total weight loss at that time. 90% maintained 5% total weight loss and 61% maintained 10% total weight loss. So very, very robust results. 27% were initiated on new pharmacotherapy as adjunctive therapy to the EGD, ESG. So not a whole lot there, but still, you know, it can be helpful and there's other studies that are looking at it. And similar adverse event rate, 1.3%. What about BMI ranges? You know, a lot of these are thought, well, if someone's eligible for surgery, we shouldn't do it. You know, if the BMI is 40 or greater, we shouldn't do these procedures. So this study was a multi-center international retrospective study, seven centers, 193 patients. All centers had, across the board, had at least a 10% total weight loss. And these centers, some, you know, we were in this study and we've done tons of procedures, but there were study centers in Brazil that had just started and all centers had over 10% total weight loss and greater than 25% excess weight loss. What was very interesting here was the predictions of success were younger age, less than 41, male sex, and a higher BMI. So if you can see in these figures here, you know, patients with higher BMIs, they did well. You got greater weight loss with that, you know, 20% here at a year, BC class three. Granted, there's overlap, but in the multivariable, it did show to be something that was related. Now what about patterns? There's a lot of arguing early on about what the best suture pattern was, the double triangle or, you know, something else. What else should we do? Z patterns and all these other things. Well, one of the best patterns I think that really, you know, we haven't proven this necessarily, but I think that there is a consensus, at least anecdotally, that the U-stitch pattern is quite effective. And what we like to do is start with a running suture down below and then start doing a U and then an interrupted stitch for reinforcement, another U, another interrupted. People have different ways of doing this. Some just do several U's, right? And there's no clear approach that's the best, but this is a lot easier than triangle, I think. And you're not having the suture, with a double triangle, you're having a long suture that is kind of bearing a lot of the load, if you will. This separates out those forces more evenly, I think, and it's probably going to end up being more durable. Some people don't reinforce, some do. And then the number of sutures varies dramatically from three to 10. So there was a study that looked at number of sutures, but this was in sleeve revisions. This is kind of the best we got. And it really doesn't show much of a difference for more sutures, you know. So it's variable here, whether you have three or five, you know, you have considerable overlap. So it's not clear, you know, that the number of sutures or reinforcing sutures are important, even though everyone feels pretty strongly. I feel it's very important to reinforce, other people feel it's not necessary, but it's all from anecdotal experience. We don't have any studies saying which one is really better. So one of the better studies looking at that U-stitch pattern was from Al-Qahtani. He studied over 1,000 patients in this prospective observational study. And the baseline BMI there is 33, so a little lighter than some of the other studies. And he had 15% and 14.8% total weight loss in 12 and 18 months, a 2.1% SAE rate, you know, some perigastric collections, GI bleeds. And what has been, you know, coming out in some case reports is getting the gallbladder, putting a stitch through the gallbladder and getting bile leaked. So that's something just to keep in mind as well that you do see with this procedure sometimes. And then there's a 1.3% revision rate. Another thing that he found is that you can actually revise these procedures. That might be a selling point for Apollo, or it might be, you know, a detractor, is that, you know, you can actually cut and remove many of these sutures and release it if you want to, if the patient loses too much weight, or if they decide they want to have a surgical procedure and don't want to have the risk of a leak maybe afterwards by hitting one of the tissue anchors that are left behind. So something there that's quite important to feature to know. And again, you can see here where in the figure to the right, the percent weight change is very similar for his ESG as compared to a laparoscopic addisable gastric band. Then we have a meta-analysis, you know, looking at 1,772 patients across eight studies. And, you know, trying to piece everything together. Efficacy is 16.5% total weight loss in a year, a 2.2% adverse event rate, and leaks are the thing that you worry about. So we have good evidence for this procedure. It's getting covered more and more by insurance programs, and that's very encouraging. There are other suturing devices that are looking to come out and do full thickness. Here's one of them. You can see here it's a curb suturing system, and it just kind of goes in one direction. So kind of see grabbing the tissue full thickness, pulling it into the device, activate the device, it's a very simple kind of lever system. You're just doing the same movement over and over. There's no reloading of needles or anything like that. So you get the idea how this works. It can go on any scope, single-channel scopes, colonoscopes, double-channel scopes, whatever you want. But you're not, you know, it doesn't have to be on a double-channel scope. It can be on Fuji or Pentax, Olympus, it doesn't matter. So an interesting evolution might be on the way with this device. And there's a few others, too, I think that I haven't had the ability to use yet. But it's encouraging that this field is starting to evolve now. And, you know, certainly the technology will start to evolve as well. So what about other imbrication analogs focusing on plication rather than suturing? So a lot of this is mucosa and mucosal opposition, right? You're bringing the mucosal layers together. You are getting some serosal opposition, but it's a little chaotic and not precise. So with plication, there's a couple of different procedures. One focuses on the fundus, and then the other focuses on the body. And it's, you know, initially the fundal ones were thought to reduce fundal accommodation, which is kind of a way to trigger earlier satiety similar to what you see in gastroenterotics. And the other one, working on the body, was, you know, thought to, okay, does this change gastric emptying? And we have some studies early on that showed maybe it actually increased gastric emptying. So not clear yet, but those are the two patterns that are used. And the device that's typically used to perform this procedure is shown here, an incisorless operating platform. And it consists of several parts. One is a disposable scope. You have a helical tissue grasper, similar to the one used with the overstitch. You have this GPROX device, which is a tissue grasping device. And then through that device, a catheter is passed that has a needle on it. So once you grab tissue, the catheter goes, you know, through the tissue. And you need to deposit these tissue anchors, which are quite robust. And you're folding tissue in to form plication. So these are the snowshoe anchors that are delivered. And they are non-absorbable graded polyester. And they have a nitinol, tiny little nitinol cinch right to the right of it there. And then this is what it looks like on the right panel with the tissue being grasped by that GPROX device, the needle being passed through the tissue, and then the first tissue anchor. So advantages to this is they're very, very durable. So you are, again, folding on the left panel. You can see you're folding serosa to serosa here, okay? And that we know sticks together. Unlike mucosa, which its job is to not stick, right? This sticks together pretty well. So once these fuse, you can see pathology in the next panel over here. And this is going to be there forever once it fuses together. And they have a nice study looking at two-year anchor placement. And the vast majority are in place. We're talking like 90% retention rates. I've had people that have had this procedure, you know, we used to, this used to be used to remove bob ladders in the old note stage, right? And you'd close the gastric entry point with this. And we have these baskets in place, we used to call them baskets. You know, the tissue anchors in place for 10 years now. So they do stay in place. This is what the first procedure looked like. It focused on the fundus. Originally, it was performed by Santiago Horgan. We were in the initial study with him. And you pull tissue into the device, okay? You grab that tissue. And then a hollow needle is passed through the tissue, comes out the other side. And then the tissue anchor is passed through that needle, okay? Because it's loaded into the needle. So the first anchor is deposited distally. You release it, the second one proximally. And then you got that full thickness plication. And again, we're focusing on the fundus in this first procedure. Now, the gray line on the bottom, this was the U.S. registry, kind of early first in man work. We got about a 27% excess weight loss. Not great. Not horrible. But we just couldn't get better than that. And no matter what we did. And then they went to Europe and got a little bit better results. But still having trouble to get it, you know, they couldn't get about 40. This is excess weight loss is what they were using at the time. Then they tripled the size of the device. And they went to a very specialized center that has the most amazing aftercare. And they were able to get 60% excess weight loss. Well, the problem was they have an amazing aftercare program, right? They're talking to the patient almost on a daily basis. And then it's just much more rigorous. They probably could get nearly this weight loss without the procedure. So this is what it looks like at a year. So it looks like it's robust, right? So this older procedure was subject to a randomized control trial. They want to spend a whole lot of time on it. But it was very rigorous. There were flaws with the design. There was kind of some perverse incentives for people to eat. Because they felt if they lost too much weight, they wouldn't get the crossover procedure. So it was pretty complicated. Additionally, the aftercare was nothing like it was in Europe. So they had about a 5% total weight loss, which is not enough. The sham was 1.38. So granted, it was significant over sham. However, not enough weight loss. So the device works. It's very durable. It's natural to figure out a different way to use it. And why not do what you do with an ESG? So instead, we started focusing on the body. And this is the belt suspenders pattern where we work on a distal belt, reducing the width of the stomach, making it narrow distally. Then we put two suspenders in there to shorten the length of the stomach and then a top belt again. You can see that in the upper right here, that pattern again. So we did this initially with a smaller device, which you'll see here. And when we use a larger device, it's even that much more dramatic where you can almost not even see the outlet of the stomach from the distal body into the antrum using that larger device. And occasionally, we have to dilate that. So it's quite robust. So you grab the tissue, you pull it in. And again, we're focusing on reducing the width of the stomach, doing a belt down near the ancestral. So we'll do several of those. Now, with a size 33 tissue grasper, that gets much smaller. But this still has quite an effect, as you'll see. And then we start working on reducing the length of the stomach by doing the suspenders and we'll do two rows of those. And again, it's all the same process here. And then, of course, we'll put a couple in the proximal belt as well. So another advantage here is theoretically, you should not be getting as many leaks or have the risk of bleeding outside the lumen into the abdomen with this because you're pulling the tissue in and placating it rather than potentially having some exposed areas out if you go through a vessel on the outside of the stomach. And finally, we'll do that top belt. And, and that's, that's what it ends up looking like, you know, a little fundus there. And then, and then you got your nice tight little sleeve right there. Now, when you use a larger tissue grasper, you use less plications and also you pull more of the fundus down so it's a little flatter. So we published our original results of this in GIE. And you can see here we studied, we studied 10 patients, we'll get into the results of it more specifically, but we're focusing on the body on the right here, instead of in the fundus. And we had about a 15% total weight loss with, you know, the majority doing quite well. But this, these tables showed a little better. So we had 10 patients. You can see we had all three classes of obesity, class one, class two, class three represented in this early pilot work. You can see also had some obesity related comorbidities listed below that. On the right, you can see the technical status was 100%. Procedure time was 101 minutes for our first, first set of procedures there. And a number of applications was 21. We're using smaller device for most of that. So now we're below that. Serious adverse events, there weren't any. And then again, percent total weight loss was 15% at six months. Now with larger device, fewer applications, we're getting up towards 20%. And when we get to 100 patients, we'll be publishing that hopefully to be 20% in one year. Goten Lopez-Nava presented, published his, his results from a single center study of 75 patients. And he just, he just, this is EPUB ahead of, ahead of print, so this is hot off the presses. And you can see he also looked at class one, class two, and class three obesity in his group. And he had a 17% total weight loss at 12 months, and that was 42 patients that were eligible at that time. So striking. He's doing the exact same thing we're doing it, whether you call it dyslipose or pose two, the pattern just is alternating slightly differently, but you're still reducing length and width of the stomach. And this was, this was quite nice. This shows that similar to that multi-center international study for ESG, you know, the, the larger the patient is, the more weight they can actually lose. So that's encouraging. It was thought with those early devices that were very superficial kind of, and they were only stitching the submucosa, you know, larger patients wouldn't benefit, but it turns out that with plication, it's consistent with what we saw with ESG. Finally, there's another new device here. And this is endomena's device, and it's very similar. It's a plicating system, just like this, this other one I was showing you. And they studied 51 patients, a mean plication of 5, 5.2, 97 minutes, no severe adverse events. Percent weight loss here is, is shown at 23 months, 28%, six months, 31%, and at 12 months, 29%. So they're looking at a percent excess there. And the BMI reduction after one year was 7.1 kilograms. So very early kind of results, not a lot of studies on this, but it's, it's quite encouraging and something that they're doing in Europe now. So another thing to keep an eye on. So that brings us to the role of EBMTs. You know, we think of, we think, we, we think of these as gap therapies, orthopedic surgery, we had exercise and medication, and then, you know, we had joint replacement on the other end of that spectrum. And then arthroscopy came in and what they could do with, with minimally invasive therapies really changed the field. Similarly, with cardiology, we had exercise, diet, and meds, and we had cabbage, then we had angioplasty, right? Now we have drug eluting stents and everything else. That gap therapy really changed the way we care for these patients. And that's when we started making true headway. I think that's what we're seeing with obesity now. You know, we have the same thing, diet and medicines, and we have surgery. Now endoscopy is starting to have a larger presence. And really, you know, my practice suturing is, is, is probably 90% of what we do. And so, and not only that, but this gap therapy has really started to approach in higher BMIs and finding better results with that. So we now have a nice spectrum of therapy and bariatric endoscopy. You know, we have the balloons down on the, on the lower end of the spectrum where you get about a 10% total weight loss. We have the suturing and placating where you can get up, up to 20% it looks like. And then we have gastrointestinal therapy, which we didn't focus on, which again, that's approved for BMI as high as 55. And you know, kind of different patient population there. And then of course we have our surgery sleeve gastrectomy with 30% total weight loss and gastric bypass with 40%. So in conclusion, endoscopic suturing and placation are proving to be effective and have an important role in the treatment of obesity. Better studies on mechanism of action are needed to be really helpful to understand how these work. And then maybe we could actually do more personalized medicine. Strong aftercare is critical to optimizing outcomes. So we do think it's very important to have your own dietitian if you can, or at least be part of a multidisciplinary group that has access to dietitians is very important. We have psychologists that work with us, surgeons on the team, et cetera. And then combination therapies, whether it's combining suturing with medicines or you know, balloons with medicines, or maybe two different procedures. Maybe suturing and then a small bowel procedure. You know, those are really important I think moving forward as is a personalized approach, kind of understanding who's going to respond better to what therapy. We think that those are going to be the keys to success moving forward. With that, you know, thank you very much for your attention and I'm happy to take any questions. All right. Well, thank you very much, Dr. Thompson for that very insightful and informative presentation. That was very good. And again, I want to thank all of our attendees who are able to join us for this webinar this evening on endoscopic sleeve gastroplasty. So as we mentioned at this time, Dr. Thompson will address questions received from the audience. As a reminder, you can submit questions through the GoToWebinar question box on the right side of your screen. So I will, we do have a couple of questions that came in here. The first question I have for you this evening, Dr. Thompson, is can endoscopic suturing techniques be used to treat GERD due to hiatal hernias? Yeah, that's a good question. You know, the TIF procedure is a suturing slash placating procedure that's been used a lot for the treatment of GERD. I perform the procedure and I find it very effective. However, it is limited to patients with hiatal hernias that are, you know, really less than two centimeters, two centimeters or less. In hill grades, it's kind of two or less, if you will. So you can do it with small hernias, but they have to be small. If they become larger, you really have to start addressing the cruel defect. And that really is only done, it can only be done surgically right now. So there are all sorts of interesting combinations. A C-TIP is something that Ken Chang does a lot of and some others are doing that now where they do it in the OR and the surgeon will fix the cruel defect and then the endoscopist will do the TIF procedure. These other devices have also been used to treat reflux. There's a couple of people that were working on an anti-reflux procedure with the Apollo suturing device. But I have used the USGI placating system to do something similar. I think we have something in video at GIE last month or this month coming up, where we combined, you know, a bariatric procedure with an anti-reflux procedure. I think Reem Sharai did that doing TIF and ESG, so he used two different devices. We did it with just the USGI placating device where we kind of did an anti-reflux procedure and then did the bariatric part of it. What's nice about the bariatric part is it really reinforces it well because it shortens the length of the stomach. And as you're doing it, you're pulling that esophagus out of the chest, elongating the intra-abdominal esophagus, which is really helpful in creating, lengthening that flap valve. So we found that it works quite well. But again, I think these techniques are currently limited to people with small hiatal hernias, if any. All right. Thank you very much. And this next question you might have to help me with. It says X-TAC from Apollo. I'm not sure if that's a device or what, but the question is, is it for full thickness suturing that could be used for ESG? So yeah, I haven't used the device myself. One of my colleagues at the hospital is using it because here at Hero Eye Heart, there's a lot of colon ESD. And the idea was that it'd be helpful for closing perforations and, you know, a little easier at doing that in the colon. So the device itself, I personally, and I've seen it, I haven't used it in a patient. I don't think it would be a terribly efficient way to do an ESG. So I would not, I would not, that would not be my preference. However, I do believe that it would be quite nice at closing perforations. And my colleague is saying it's nice to over-sew defects after an ESD as well. All right. Thank you very much. The next question here, what would you recommend as a starting point if a physician is interested in adding these procedures to their practice? Well, the ASG has, you know, several great programs on this. There's a suturing star program that really doesn't focus so much on the bariatric aspects of it, not on ESG per se, but it's a good starting point to learn how to suture. There's several other programs. We have a nice hands-on course every year, an FES program we call it down in Miami, South Beach area. And it's several days of hands-on. There are, the company itself, you can just reach out to the company and have them come and they do have a mobile unit that can be, you know, they'll have certain schedules where it might be near you and they can come by and you can maybe practice there a couple of days. That's part of it. That's the technical element. Then there's also the cognitive element, right? It's not just doing the procedure and knowing how to do the procedure and where to place those sutures or placations, but it's knowing how to take care of the patient. And that's, you know, just as important, right? How often should that patient have follow up with a dietician? How often should you be seeing the patient? Do they need to see the psychologist? What exactly is the best diet program for them afterwards? What if they stop losing weight? What medicines do you want to introduce when, or do you have a medical bariatric specialist you'll be working with? So you need to answer all those questions and the ABE actually does have documents that help with that. There's several review articles that help with that and they do have programs. So hopefully the ABE program prior to VDW oftentimes will address those things as well. And then also there's shadowing. We always have people shadowing us at the Brigham and we welcome that. And there's several other places that are starting to do more of that as well. All right, Dr. Thompson, thank you very much for that. The next question I have for you, I find that there is a lot of reservation amongst teaching faculty across the country about the future of endoscopic management of obesity. Personally, I am fascinated by it. From a policy and Medicare reimbursement perspective, what's in the near future for bariatric endoscopy? Good points. I think that's unfortunate. I think they thought that about EUS too. I think they felt like EUS, that's a device in search of an application. That's what they used to say, right? What's that going to be good for? And it's good for a lot of things now. So I think that certainly there is a track record of some devices not doing well in bariatrics or not surviving the FDA. So there's some truth to that. However, we're seeing such great results with endoscopic suturing and endoscopic placation. These patients are losing almost as much weight as a sleeve gastrectomy does without nearly the complication rates. And if you need to bolster that with some medications, you might be able to get very comparable results. So I think that's very encouraging. Additionally, insurance companies are paying for these more and more. We do hundreds of procedures a year. And the vast majority are covered by insurance, right? So there's two of us that do most of these at the hospital, and it's rare we're doing out-of-pocket kind of procedures. However, we do have a very robust pre-approval process, and we spent a lot of time talking with the insurance companies, right? It's not like we just do it and then build the insurance company. We do a lot of negotiating upfront. We send pre-approval letters in. We debate each patient with them, and it's a program that we've kind of gotten running. But it's not easy. I'll say that. There's a lot of heavy lifting, but they do reimburse rather nicely for it. So in the end, it's certainly worth doing. So I would encourage people to continue to pursue this, and I really am quite bullish on it. Well, thank you very much. That's actually very positive feedback as well. The next question that I have for you, Dr. Thompson, is in patients with large pouch following RYGB, in addition to reducing the outlet, how much reduction of the pouch is performed? So that's a good question. There was a study, wow, I'm trying to think of the year. I was the lead author on the thing. It was using a plication system, and we found that the outlet reduction was more important than pouch reduction. So if you can reduce the outlet durably, the pouch reduction was less important. So we have to focus on the outlet. Now, if you do have a large baggy pouch, it probably is a good idea to reduce it as well. But if you really are focusing on one or the other, you want to get the outlet down, and that's the thing you can't ignore. So it was a prospective study that was being done. It was a registry study, and they were doing something called a ROSE procedure. And what we did was afterwards, we went back and looked at, some centers are only focusing on the pouch. They didn't ever put plications in the outlet. Maybe once in a while they would, and then other centers are focusing mostly on the outlet. The ones that focus on the outlet got much better weight loss results. So clearly, the outlet was more important. If you're doing suturing, okay, it is very common to reinforce the sutured area. So if you do a purse string around the outlet, then you back into the pouch just a little bit and reinforce it. That should be done on all patients, just because it takes the pressure off the outlet. So it's not bearing that burden alone, right? And if it's a purse string, it's one suture trying to hold that tissue together. You want to try to support that. So you always do some plications or sutures kind of on either side of the outlet, just proximal to the outlet to reinforce it. And then we'll, maybe if it's a really big pouch, we'll do a little ESG U-stitch in the pouch as well. I just don't know what that contributes, but anecdotally it makes me feel better, but I can't say it contributes to weight loss or durability. I just don't know, but it looks better afterwards and that's kind of why we're doing it. Okay. Thank you very much. This next question, it definitely has commercial bias in it, but I'm going to ask it for you anyway. And the question is over stitch versus pose two as regards to durability and weight loss results, which is better? There's no comparative studies. So anything I would be saying would just kind of be anecdotal experience. I think either one of them are wonderful procedures. They're very effective and patients are losing weight with them. I think there's advantages and disadvantages to each. So we offer both at our hospital and we tell the patients about both options and give them the pros and cons. I think the one pro with ESG with Apollo is that you can reverse the thing, right? You can get those sutures out if you need to. Say they want a sleeve gastrectomy because they don't lose enough weight, it's very easy to remove those sutures and then have a safe sleeve gastrectomy. With pose, you cannot get those things out. I've tried. Endoscopically, you can't get them out. They're not coming out, right? So then the question is, can you perform a sleeve gastrectomy over those placations? And most surgeons will say it is not safe to do that. So the way the procedure is developed and designed, you can still safely do a gastric bypass because you've spared that gastric cardiac area. But still, if they want a sleeve gastrectomy, you can't reverse it. So that's an advantage to Apollo, right? An advantage to USGI might be, who knows, maybe there will be more durability there because you can't remove those things. Could be the stomach obstruction around it. I don't know. So we need more studies. Right now, it looks like the weight loss is trending a little better for placating, but it's hard to say. So I think that either one of those procedures are quite effective and they're both being covered for our patients up in Boston. And I think that you can't go wrong with either one. I think Apollo is a little more accessible in the US and they have a very robust training program. So that's another advantage. Whereas with the USGI platform, it's a little harder to get. They focus more on the outside of the United States, doing procedures there. And it might be a little easier to learn, but that's my best I can do for comparing and contrasting those. But I think they're both pretty viable procedures. All right, great. Very good. And then the next question I have for you, can you comment on your experience with suture damage and durability in patients who have undergone ESG with overstitch? So suture damage, I'm not sure I'm understanding that one. Can you ask it again? What it says is, can you comment on your experience with suture damage and durability in patients who have undergone ESG with overstitch? Yeah. So I think what that's getting at is when you're running the suture for many, many bites and you're placing many stitches, that proline can get damaged. It can become nicked. And once you get a nick in it or it starts to become frayed, it's very fragile. That's a problem because if it's in the part of the suture that you're going to be keeping in the body, that thing could break down and you're going to lose that plication, if you will. So that's problematic. Also you could lose it during the procedure, especially if it's right near the needle itself or the tissue anchor. As you're suturing and it becomes frayed, when you're tightening it at the end, it can pop. And then you have, if you took seven bites, you'd have 14 holes, 14 little perforations to contend with. So it does happen. And I think it's very important to not touch the suture with the helix. That's one thing that does damage it. So it's very important to do that. Always keep it visible and do not let it come out of the device at an angle. You want to always keep the suture coming straight out of the device. If it's riding over the device, either to the left or right, the device itself is rough and it can damage the suture there. And then you start getting a frayed suture, especially as you're doing these use with many more bites, some people putting 14 bites in. So, you know, that certainly is something to be very mindful of. And there's a couple of tricks to avoid that. And I do think that if you have a damaged stitch, that would compromise your durability there. And it's good to kind of over-sew that area more aggressively, if you note that. All right. Thank you very much. And the next question I have here, it says, can you comment on ACP ablation alone versus I'm sorry, it's APC ablation alone versus APC and suturing for TOR? Sure. So there was a study out of Brazil that did that comparison. However, they were doing interrupted suturing. And so we don't we don't do that because we know we get less weight loss with it. So that's not a fair comparison to the current technique. And that group's a phenomenal group, but they're new to suturing. So they weren't doing purse strings. And so they found that, you know, APC was, you know, was very effective in that, you know, it's of no benefit to do suturing in addition to that necessarily. However, they're still suturing because they're learning the purse string technique. What we need is a good comparison to the purse string technique. In our center, we have looked at that retrospectively, and we found that suturing is much better in certain patients, right? So if your outlet is quite large, so say you have an outlet that's 18 or 20 millimeters, that would require in general, a few sessions of APC might bring that person back three times. And some of those patients, you know, they won't get to their target size or their target weight over those three sessions. And you've damaged the tissue a lot, making suturing much, much harder. So that's something all that must be considered in the studies. Now if you look at a patient with again, an 18 to 20 millimeter outlet, and you do suturing, that tends to be very effective, right? But now if you have a patient whose outlet's smaller, say their outlet's like 10 millimeters, but it's not very, it's very stretchy, right? So it's incompetent. It doesn't work, even though it's small. That's great. That's a great patient for APC. You probably just need to, you know, APC around that thing once. You don't even have to be terribly aggressive, maybe 70 watts. And you know, that could be a very effective procedure for that patient. So again, a little bit of personalized medicine, it's really patient specific. And one of my colleagues, Dr. Girapino has an article out on that, it's kind of a treatment algorithm if you will, where, you know, when do you do what procedure? And we presented this at DDW a couple of years ago. And it really does come down to kind of size of the outlet. And that can help you maybe pick which patient is better for which procedure. All right, very good. We're getting a lot of Apollo questions this evening. The next question I have for you, up to how long after ESG with the overstitch device, can you reverse it? I think you're going to reverse that for the most part, you know, as long as it's in place, because what you end up doing is cutting the tissue bridges. And when you do that, I don't know if we published a video on this, I know we had some really good material for it. I don't know if Al Qahtani has either. But I heard about it first from Al Qahtani, because I didn't really think it was safe to do, but he'd been doing it. So then I started doing it. And it works really well. So if you have, you know, one of those typical tissue bridges that you see in these procedures, you just take an incisor scissor and cut through that, you know, you actually see the sutures in there still, they'll recede. And the area opens up and then you can pull out the material, you can pull out the suture and usually the tissue anchor as well. So we've done that in people out over a year, two years, we've been able to reverse it. So you might not be able to 100% reverse it and you don't know there is some contact on the serosal surface, although it is not direct contact, right? It's not precise, but there is some contact in the serosal surface. So you might have little knots, if you will, on the serosal surface that the surgeons will note if they go in to do a revision or say a sleeve gastrectomy. But I do think it's safer to get all that material out of there. And I think you can do that pretty much anytime afterwards. All right, thank you. We have time for just a few more questions here. The next one I have, is there any risk of gastric malignancy associated with the ESG procedures? Well, there's been no risk shown to be associated with it, but if you do have a subject that is a high risk of cancer, a family member with cancer, maybe someone from an Asian population that is at greater risk of gastric malignancy, you really have to think twice about doing this procedure because you can create little pockets that are not as easily accessible, right? And so it's something to think about if you are suturing and creating these inaccessible areas that can't be surveyed. Similar to a gastric bypass, you don't want to do a gastric bypass on one of those patients because it's so hard to get to the remnant stomach, right? You'd prefer a sleeve gastrectomy. In those cases, I think placating is better because the placations, everything is always visible with a placation, right? You're not folding it in a way where you create these pockets that aren't as easily seen. But I'm not aware of any risk of cancer due to the material being kind of stuck in the stomach or maybe food getting trapped in a pocket in some way. I haven't heard anything about that yet. All right. Thank you very much. And the last question I have for you, it says, I can see that an endoscopic bariatric approach can have an advantage versus laparoscopic since the former may not have to, and it says a truggle with the heavy adipose tissue. Is there anything to this? Yeah. So, you know, it is so, so laparoscopic surgeons have issues with a lot of different things, right? They have an abundance of adipose tissue and the momentum they have to contend with, the liver can be very large. And depending on where they're working in the stomach, if they're trying to create a small pouch up in the cardiac and have enormously heavy liver there, you know, that can cause them problems. And a lot of times that's why they put patients on these liquid diets and kind of these high intensity lifestyle modification programs prior to surgery is to get them in better shape for the surgery. You know, get them to lose some of that old mental fat, lose some fat out of the liver, try to buff them up for their procedure. In super obese patients who have really high BMIs, there may be a role for endoscopic procedures to get them down to a target weight to then do a surgery because the procedures are easier to perform in those patients and potentially a little safer, right? So we have actually had our surgeons send us patients that are rather large to do procedures on to get them down to a healthier weight so they can do their procedure. And that's when they think that you've got too much to lose. So medicines and lifestyle modification alone won't be good enough, or they've already tried a medicine lifestyle and it didn't work. So that's something to be said for that. As far as, you know, competing, say someone has a BMI of 70 or 60, you know, something high 50, something like this, yeah, it might be easier to perform our procedure. However, a lot of times these people have other metabolic things going on when they're that large. And there's a certain quality to a rheumatologic bypass where you're bypassing that foregut that has other metabolic benefits that this procedure doesn't necessarily confer. So I wouldn't necessarily go after those patients as, you know, there's no data to say that this procedure would be better than surgery on those patients. I think maybe as a bridge to surgery, depending on what the surgeons feel. I know that more and more endoscopists are doing heavier patients, but I think that, you know, for now we just don't have enough evidence to suggest that it's as good as a gastric bypass for those patients. So I probably wouldn't really, really go there. All right. Well, Dr. Thompson, I would, I want to thank you again for your presentation this evening and for taking time out of your schedule to be able to do this for the ABE. And I also want to thank all of the attendees this evening who were able to make time to be on this webinar. We hope that this information is useful to you and your practice. You will be receiving a survey after this program and all feedback is welcome. A recording of this webinar will be available in approximately one week on ASGE's GI LEAP. And then you will have ongoing access to this recording as part of your registration. If you have any questions about GI LEAP, please contact education at asge.org. This concludes our webinar for this evening. Please visit the ABE website, which is www.weareabe.org, for a list of other upcoming educational opportunities. Thank you very much and have a good evening. Thank you.

endoscopic sleeve gastroplasty

ESG

webinar presentation

Dr. Christopher Thompson

endoscopic suturing

placation devices

bariatric endoscopy

training

successful outcomes

obesity treatment