Hello, everyone, and welcome to our webinar, Training in Bariatric Endoscopy, sponsored by the Association for Bariatric Endoscopy, a division of ASGE. My name is Marty Roth, and I will be your moderator for this webinar. Before we get started, I have just a few housekeeping items. There will be a question and answer session at the close of the presentation. Questions can be submitted online at any time during the presentation by using the question box on the right-hand side of your screen. If you do not see the question box, please click the white arrow in the orange box located on the right-hand side of your screen. Please note, this webinar is being recorded and will be available for future use in GILeap, ASGE's online learning platform. At this time, I would like to introduce Dr. Allison Shulman, our presenter for this program. Dr. Allison Shulman is an assistant professor in the Division of Gastroenterology and Hepatology at the University of Michigan. She received her bachelor's degree from Cornell University in Ithaca, New York, and her medical degree from Weill Cornell Medical College in New York City. She then received a master's in public health at Harvard University. She completed her residency in internal medicine at the Brigham and Women's Hospital in Boston, Massachusetts. Following residency, Dr. Shulman completed fellowship in gastroenterology and went on to complete two additional fellowships in bariatric endoscopy, followed by advanced therapeutic endoscopy. All of her training was at Harvard Brigham and Women's Hospital. Dr. Shulman's research has focused on endoscopic management of obesity. She is specifically interested in management of complications following bariatric surgery, primary endoscopic therapy for obesity, and innovation and device development in endoscopy. I now present to you Dr. Allison Shulman. Thank you very much for the invitation to speak tonight. As you know, I was asked to talk about training in bariatric endoscopy, and it's very much an honor to be here and presenting on this topic. This is a rapidly changing landscape, so it's an exciting time to think about all of this. Here are my disclosures. So I thought we would discuss training in bariatric endoscopy by breaking it down into the who, what, where, how, and when. But before I jump into those, I just wanted to start with why. So the prevalence of obesity has been increasing in the United States, and with that has come an increase in obesity-related comorbidities. And surgery is effective. It leads to significant weight loss. It leads to improvement in obesity-related comorbidities. However, surgery alone clearly cannot contain the epidemic of obesity. So less than 1% of eligible patients actually undergo bariatric surgery. And furthermore, it carries a very high risk profile. So when we think about the spectrum of obesity management, you can see that standard lifestyle interventions are very low risk, but also are lower efficacy, as they only result in about a 3% to 5% total body weight loss. Surgical procedures, on the other hand, are very effective, but also much higher risk. And so we think that endoscopic bariatric therapies very much fill the void between these two extremes. So now that we have covered why, I'm going to outline the rest of the talk. And I'm going to start specifically with focusing on the level of training or practice of the individuals. And then we will cover what key elements of training are, what tools you really need for success, where these training opportunities may be available. And in the last few minutes, we'll focus on once you are sort of trained, how do you think about launching your own endoscopic bariatric therapy program? So as I mentioned, this is a very rapidly evolving field. And some leaders in this area are very much beginning to think about sort of the structure in a more formal manner. So I want to draw your attention to an extremely relevant article, which was recently published by Dr. Thompson's group in Boston. And I think it really lays out some of the details and touches on some of the concepts that I will be talking about today. And more recently, Dr. Ahmed Bazarbashi also published a short editorial on training and bariatric endoscopy that I encourage you all to review. And even more recently, the ASGE training committee also published the obesity core curriculum. So I think this is also very relevant reading if you have interest in this topic. So let's jump right into things. Who should be trained in endobariatric therapy? So obviously we have a very diverse audience, including providers probably trained in medicine, trained in surgery and other areas. But regardless of your prior training and experience, in order to gain skills in an advanced endoscopic technique such as this, you really need to be comfortable with standard endoscopic techniques. And training goals may differ based on level of training. So people are coming from all different backgrounds as we discussed, GI, surgery, et cetera. Some people are in training or some people are already practicing and interested in expanding their practice. And additionally, training can occur at many times. So specific training could be pursued during a standard three-year fellowship or as an additional fourth year after fellowship. Another very important variable relates to the need of the endoscopist and their practice environment. So specifically, are you looking to be able to offer primary endoscopic bariatric and metabolic therapy? Or are you more interested in helping complications from prior surgical procedures? Or do you want more of a hybrid model where you can sort of offer everything that is needed within the environment? And there's also a lot of variability in practice. There's academic versus non-academic. There's rural versus urban practices, resources, including the strength and expertise of your bariatric surgeons or other services, including endocrinology and nutrition, the specific patient population and prevalence of obesity and other comorbidities may affect these. And all of these things will really help sort of drive the type of procedures that are important for you to carry out safely and effectively. So as I make the point that clinicians in different settings need to develop different skill sets, let's drill down a bit more on exactly what procedures are sort of in your admonitorium as a bariatric endoscopist. And so there's a variety of different complications seen following gastric bypass, following sleeve gastrectomy, following lap band placement. And then, of course, there are a variety of different device and techniques in order to sort of be able to perform primary endoscopic bariatric therapy. And Drs. Girapino and Thompson really laid out five training goals for this type of program. And I think it's a worthwhile framework as you start to think about this field. So obviously, there are many different ways to achieve competence in this area. But this is one really nice approach laid out by these authors. And as I already mentioned, not all trainees will achieve all of these goals. But there are for those that are interested in developing sort of a clinical niche in this area. So perhaps the most important thing is a very strong foundation in the physiology of obesity. And this includes an understanding of both the physiology and the pathophysiology. It includes understanding both the genetic and epigenetic factors that may contribute metabolic abnormalities, hormonal imbalances. Changes in the microbiome are thought to play a role, including bile acid composition and motility changes. In addition, it's important to be able to diagnose and to treat obesity-related GI conditions such as NAFLD or NASH or gallstone disease or GERD. And perhaps equally as important to an understanding of the sort of physiology and pathophysiology is recognition of the interdisciplinary approach to obesity management. So many of us are familiar, especially at University of Michigan, with Bo Schembechler, who was the University of Michigan football coach who delivered the legendary the team, the team, the team speech. And I really very much think that this holds true for obesity management as well. So you really need to learn about all available treatment options. You should become one of the experts in sort of dietary changes, physical activity, medical therapy options, both endoscopic therapy and surgical interventions. And there should be an emphasis that's placed on this interdisciplinary team approach. It's unlike many other things in medicine. You also want to consider rotating through a bariatric center of excellence and also emphasize sort of the importance of integrative care through all of this. And there are many different approaches to this. And of course, resources differ from one institution to the next. But to give you an idea of how we carry this out, this is a schematic sort of representing our multidisciplinary team. And I will show this again at the conclusion of the talk once we talk about sort of how to launch your own practice. An important component of this is that all of the team members are communicating and working together and seen as crucial for strategy of the team. Another key component to any endoscopic training program is an understanding of post-bariatric surgical anatomy. So trainees should understand both the surgical anatomy and the physiology that occurs as a result of that surgical anatomy. They should be able to identify surgery based on endoscopic findings and to also understand complications and how to medically and endoscopically manage these complications. And this underscores these two videos, this sort of underscore the importance of becoming familiar with surgical anatomy as strictures following different types of surgeries are treated very differently. So on the left, you can see a stricture following a Roux-en-Y gastric bypass that was refractory to serial balloon dilation. So we're placing a luminoposing metal stent. And on the right, you can see a stricture following sleeve gastrectomy, and we're placing a stiff guide wire in preparation for pneumatic dilation. So it's very important to know what the surgery was and what the endoscopic intervention would be to treat that issue. Obviously, anatomy of prior surgery is vital to safely care for these patients. So in addition, any comprehensive program will really need to require training in endoscopic therapy as well. And so this is very much a moving target as new devices and new approaches are described very frequently. But trainees should really be able to identify all currently available endoscopic bariatric and metabolic therapy devices and procedures. They should understand when endoscopic therapy should be considered. They should understand the mechanisms of action of each of these therapies, the efficacy, what the adverse event profiles are. And it should very much be individualized in the context of patient candidacy. So as you can see here, there is a plethora of devices available from which to choose. And I will go into more information about some of these shortly. And while I do not want to focus on the details of this slide, clearly a very comprehensive understanding of both the indications and the contraindications to each of these different endoscopic therapies is exceedingly important. So you do not want to offer procedures that are too risky for some patients or ineffective for others. So in order to be able to individualize therapy, you really need to be aware of the patient characteristics and their desires. So it is very important to understand what is their initial BMI, what is their ideal body weight, what comorbidities do they have, what is their financial status, and what are their risk aversions. Specific discussions about each endoscopic bariatric metabolic therapy are very important because, for example, for aspiration therapy, you want to understand and the patient needs to understand how aspiration will fit into their daily life. And then maybe after a full discussion of all of these therapies, you want to reconsider lifestyle therapy or medications or even refer to bariatric surgical procedures. So appropriate selection of patients and procedures is a large component, obviously, of endoscopic bariatric metabolic therapy, but we cannot overlook the technical aspects of learning these procedures. So these authors really suggest two distinct training levels, one that is more basic and includes some of the simpler endoscopic techniques, including intragastric balloon therapy and aspiration therapy, and one that's significantly more advanced and includes suturing and other plication techniques. And this is a model which really separates training into two levels, but it's important to remember that not every endoscopist will want to or need to progress to level two. So we're going to start with a quick review of level one, and included in level one are the intragastric balloons. And while I do not want to go into too much detail about these, I do want to just mention those that are FDA-approved. And the top two balloons that you see in this picture are fluid-filled. They're silicone spheres. They're placed and removed endoscopically, and they remain in the stomach for six months. Recently, reshape is no longer really commercially available, but you still may see patients who have reshaped devices in their gastric lumens. The bottom balloon is a gas-filled balloon. It's filled with nitrogen, and these are thin polymer ellipses. They're sequentially swallowed every two to three weeks, and then they're removed endoscopically six months after the first balloon was placed. And as you can see here, placement and deployment of these balloons is really not technically complicated. So this is a fluid-filled balloon, and certainly they require training and experience, but it's just not the most complicated psychomotor skill to develop. So as you see, a catheter is being advanced under direct endoscopic guidance into the stomach, and then it's being filled with 500 to 700 cc of fluid, and then it's being left in the stomach. And similarly, aspiration therapy sort of mimics PEG-2 placement, something that most endoscopists are already doing or comfortable with learning. And as many of you are familiar, this really facilitates removal of a portion of gastric contents after a meal. Typically patients are aspirating about 20 to 30 minutes after a meal, two to three times a day. And this removes about 30% of calories consumed during the meal itself. And again, this falls in really in line with level one training. So for those endoscopists interested in developing more advanced expertise, level two really describes the more complex endoscopic approaches to obesity management. And certainly you saw the relatively simple and straightforward balloon placement and aspire placement in contrast to these more technically complex devices, which are available now and also new ones that are in development. And these require much more training and experience in order to be able to use them safely. Again, just to show you how much more complex each of these devices are, on the left, you can see endoscopic suturing during an endoscopic sleeve gastroplasty. And on the right, you can see endoscopic plication using the incisionless operating platform by USGI. And of course, many of us can relate to the challenges of learning advanced endoscopic techniques. And while you may be able to stand in one place doing sort of a simple EGD or inflating a balloon, these complex devices often lead to incredibly uncomfortable and awkward positions as evidenced by my prior advanced and bariatric endoscopy fellow, who's a wonderful sport, but also found herself being tied in a knot. And I'm not sure if she was able to make it to the recording to listen tonight, but I'm sure I will be hearing about this later. So the idea of training stages is not unique to bariatric endoscopy, but as patients become sicker and more complicated, and procedures become riskier and more challenging, the medical education world has really had to sort of rethink our approach to procedural training. And while many of us changed in an era of sort of the see one, do one, teach one, that's really no longer acceptable. And in the 1990s, procedural teachers really proposed a more rigorous approach represented here, which includes the idea of repetitive learning and seeing and practicing and doing a task a number of times before being deemed competent. And finally, more recently, literature has described perhaps the most comprehensive procedural teaching approach, which is the learn, see, practice, prove, do, and maintain approach. So the key differences here, of course, are the addition of prove and maintain components. So we should be able to prove that we can do something and we need to demonstrate that we can maintain our skills. So how do you go about getting this training? Obviously it's very important to seek out facilities where this training is available. You cannot get this training unless there are people actually performing these procedures. So usually these are done in the hospital setting, although sometimes they are performed in the ambulatory care center as well. And then finally, they need to be centers that are equipped or sensitive to bariatric patients. So you should be thinking about things like armless chairs, large stretchers, obesity scales. Oftentimes they're performed at bariatric centers of excellence. So you need to have the multidisciplinary team that we discussed previously, the medical bariatrician, the surgeons, the endoscopist, the psychologist, the lifestyle coaches. In addition, of course, you need to be where the educators are and where the people who are skilled to teach you these techniques are available to teach you, and so, of course, that requires people to have expertise in both endoscopic and medical bariatrics. It may require a multidivisional team of faculty. It also requires nurses and techs and surgical backup and, of course, hands-on courses at both universities and professional societies are invaluable. So, where is this training happening? A lot of the cognitive components and observations of techniques and during procedures can be done virtually or remotely by reading, and there are several online resources that I've listed in this slide, but things like the AGA White Papers, the AHA and TAS guidelines are exceedingly relevant and important. The ASGE Bariatric Endoscopy Task Force, writing PIVI documents and meta-analyses on bariatric therapies, should be read. There's also Advances in Obesity that has been published, and then, as I noted at the beginning, there's this Obesity Core curriculum that recently came out earlier this year. Additionally, watching videos can be exceedingly helpful, so the ASGE Video Tip of the Week did a bariatric series, which we were part of when I was at the Brigham working with Dr. Thompson, and there's also the ASGE Endoscopic Learning Library, the bariatric DVD sets that were recently updated. Additionally, you should ideally include some simulation so trainees can sort of practice complex and risky procedures in a safe space without putting patients at risk, as the hands-on practice is sort of a key component to any training program. There's a variety of training courses where you can get this experience. Of course, the ABE has their annual meeting at DDW, and the ABE and ASGE offer a variety of different bariatric courses in Downers Grove. The ACG has their annual postgraduate course, and oftentimes you can get hands-on there. There's also the ASMBS and Obesity Week, and of course, there's the Flexible Endoscopic Surgery course in Miami every year, and then there's many, many device company training courses, several of which I teach, and are great opportunities to get hands-on experience. Then, of course, there are fellowship training programs, so for those of you who have the ability to spend extra time, Dr. Thompson established sort of the first fellowship program and trained many fellows over the years, some of whom you can see in this picture, and this is at the Brigham and Women's Hospital, and this is a one-year fellowship. But there's also other institutions and locations where some training experience can also be offered. I know University of Colorado has had several fellows rotate through. At University of Michigan, we have also had fellows rotate through, and I suspect that there are many other programs that have these fellowships available now, and more formal programs that will be coming throughout the country and probably internationally as this field evolves. Board certification in obesity medicine may also be important for some of you, and it may be particularly important if your hospital or local hospital requires some sort of privileges in order to do your procedures there, so in the last few minutes, I just want to briefly discuss, once you've trained and when you're finally sort of on your own, how do you really start launching your own program?, and I come back to this slide about sort of establishing a multidisciplinary team, and I'll walk you through some of the key components that I started at University of Michigan. So, very much, we emphasize this sort of integrative, multidisciplinary approach. It should very much mimic a bariatric surgical program or center of excellence. It's important to think of the patient as a whole. You want to know the diet, physical activity, behavioral therapy, what other options are available, medical weight loss therapy, all of the endoscopic interventions that may be at play, in addition to any surgical interventions and maybe a surgical referral, depending on their BMI and their comorbidities, but most importantly, you want to have awareness of all of the available treatment options so that you feel that you have provided the patient with all information that would be useful in making a decision, and you do not necessarily need to employ all of the professionals within your own practice. You could be part of a referral network, so you could refer and you could also accept referrals, so, as I mentioned before, this sort of demonstrates our program that we have built at University of Michigan. We speak all the time with all of these different groups. Every patient sees all of us, and it's very, it's a very thorough program in that we take very thorough weight histories, dietary histories, life events related to weight regain or gain, reasons for success or failure. It's important to discuss with every patient what their weight loss expectations are, and it's also important to screen for exclusions, and we have amazing GI psychologists who help us with this. They discuss with patients different eating disorders that they've had that may make them more or less of a candidate for a certain procedure, psychiatric disorders, substance abuse disorders, unwillingness to follow the program, or maybe one of the providers has picked up on the patient missing several appointments with another provider in the past. You want to screen for also barriers to exercise, so maybe before performing a procedure, you want to refer to an exercise physiologist or a physical therapist, and you may end up starting more patients on medical therapy for weight loss than you offer endoscopic bariatric therapy, and you also, as I mentioned before, you want to have a solid surgical team to which you can refer patients who may benefit more from a surgical approach, so you very much want your program to mimic a bariatric surgical center of excellence, or at least that is how I've set up our program, so they have many informational meetings, psychological evaluation, dietary evaluations. We review them multidisciplinary as a group, and then we eventually meet them and pursue the treatment if we all agree that it is a reasonable approach. You also want to provide program protocols, so it's important to think about cost. This needs to be negotiated with the hospital. and with the revenue division, and you want to build a business plan in order to approach the cost. You also want to think about what duration of program do you want to have, and so at University of Michigan, we put together a one-year program where a patient is entitled to six provider or endoscopist visits, three behavioral psychology visits, twelve nutrition visits, and then also meeting with a medical bariatrician or endocrinologist, and then you also want to think about contingencies, so do you offer supplemental insurance? What happens with redo procedures or patients who are intolerant to certain procedures? How, what work are we use will you gain from the procedures? You want to think about sort of day of procedure protocols, so what anti-emetic medications are you going to provide? Are you going to give antibiotics? What proton pump inhibition are you going to offer? That will vary based on the type of procedure that you're performing, whether or not you want to give vitamins to patients. What day of procedure instructions do you provide? Oftentimes, these are in regard to, you know, restrictions like avoiding heavy lifting, avoiding driving if they've undergone a procedure, and then you may also want to provide diets for patients to see ahead of time so that they have something to prepare for. Many of our patients go home with tables like this, and they can prepare and get all the protein shakes available for the next month so that they feel prepared and they feel ready, and then we also use a variety of different meal tracker tools so that we can get a sense of what they're eating on a day-to-day basis, and we can make adjustments in clinic. So, in conclusion, training in endobariatric therapy is clearly complex. There's a cognitive component, which includes things like the pathophysiology and the physiology of obesity, the subtleties of medical and endoscopic therapies, when bariatric endoscopy should or should not be offered, and then there's also a technical component, so should you advance from less to more complex procedures? But the most important thing is to work as a multidisciplinary team, and as the field continues to evolve, I suspect that structured curricula will provide more complete guidance in regard to training. Thank you very much. Well, thank you very much, Dr. Shulman, for that insightful and informative presentation, and I also want to thank all of you who are attending and joining us for this webinar this evening. I hope you find this information useful. So, at this time, we will open up for some questions from the attendees. As a reminder, you can submit a question through the question box. If you do not see the question box on the right side of your screen, please click the white arrow in the orange box, and you can ask questions that way. The first question we have this evening, what are the best procedures to start with in order to learn endoscopic suturing? Oh, so thank you for this question. This is a great question. Based on the endoscopic suturing courses that I have taught, I think that most people would have different opinions on this topic. Oftentimes, people say stent fixation, you know, suturing an esophageal stent to the esophageal wall, is cited as a good first procedure, since it's a single stitch or two stitches to sort of secure a stent. However, I think this can be a bit more challenging, given the small luminal diameter and the orientation of the device to the esophagus. So, I personally find that something like gastrogastric fistula closure or even a TOR procedure, if you want to start with maybe interrupted stitches instead of a purse string approach, might be easiest, because these tend to be somewhat ischemic areas, and so there's less oozing. And you also have the room to maneuver in the gastric pouch, unlike in the esophagus. All right, thank you very much. The next question that I have here, what is the best approach to learning endoscopic suturing? Would it be on models? Would it be ex vivo? Or in humans? What do you feel is the best approach? Oh, that's another great question. I would get as much hands-on experience as you can before moving on to human cases. So, that includes things like simulation models, working with your mentors and device companies, suturing pig stomachs, which is what I used to do almost daily when I was in training, understanding really sort of the mechanics of the device, so that you know the steps and can anticipate sort of what could go wrong before it actually happens. I will say that the sort of in-human experience training is invaluable, and there's certain components of it that really cannot be easily replicated in a simulated model, like bleeding or like motility issues with the, you know, with the root limb or whatever it may be. But you should really be ready for it once you move to humans, because I think that transition will be a little bit easier. Some of the courses that I've taught for the overstitch in particular have dedicated part of the day to sort of figuring out things that could go wrong, whether it be crossing your sutures or running into bleeding or dropping the needle tip early, and so I think those parts of the courses seem to be the most well-received by participants, so I would definitely encourage you to get as much sort of, you know, ex vivo or simulation experience as you can and practice all of those different things that can go wrong before you take it to the human, but I do think, as I mentioned initially, that there's an invaluable component to doing as many cases as you actually can in humans, because you're going to learn from pretty much every case you'll do. All right. Thank you very much. Let me see here. The next question I have for you. How many procedures do you need to perform in order to be competent? Oh, that's a tough one. I think the only data that really exists, or the data that I'm most familiar with in the primary endoscopic therapy world is from one of my colleagues, Dr. Reem Shariah out of Cornell. I know a couple years ago, she looked into how many procedures would be required in order to be competent in endoscopic sleeve gastroplasty, and I believe that what she found was that efficiency for endoscopic sleeves was attained after something like 38 ESGs, but mastery wasn't really considered until the mid-50s, so I think she had found around 55, and of course, this was really a single operator study with a provider who had a lot of experience, obviously, with the device and also with other advanced endoscopic techniques, but it gives us some insight into numbers. For most things in endoscopy, I think we are now sort of focusing more on competency as more of a general skill that is achieved as opposed to a specific number of procedures that are required to attain that skill, but it's always nice to think about sort of where you stand within those numbers, and I think the more experience that you can get, your learning curve is going to accelerate quickly. All right. Thank you very much for that. The next question I have is actually from a GI fellow, and their question is, if you are interested in level one training, and then they have in parentheses intergastric balloons, do you need training in advanced endoscopy? So that's a great question. The short answer to that is no. There are several bariatric endoscopists who do not do interventional fellowships, who mostly focus on the level one techniques or even move on to level two without training in interventional endoscopy, so especially for things like intergastric balloons and Aspire, those are procedures that can be performed by anyone who can really demonstrate competence in that area, and those are much easier skills, as you saw during the talk, to achieve competence than some of the other skill sets. That having been said, there are several bariatric endoscopists who did not do interventional training, who still do a lot of endoscopic suturing and plication procedures, so it may just be a bit limiting in terms of how you manage complications from prior bariatric surgery. For example, one procedure that many of us find ourselves doing quite often now are edge procedures or gait procedures, where in patients with gastric bypass anatomy who for some reason or another need evaluation of the remnant stomach or the duodenum or the bile ducts or the pancreatic ducts, we are now, under endoscopic ultrasound, creating basically a connection between the pouch and the remnant stomach, and those are interventional endoscopic techniques, so unless you have done training in interventional endoscopy, you wouldn't be performing those types of procedures for complication management in patients with gastric bypass, but the more simple procedures or sort of dedicated bariatric endoscopy procedures, such as suturing or plication techniques, could be learned in the absence of a full advanced endoscopic fellowship. All right, that's very good information. So the next question I have here, does insurance cover ESG? Great question. There is variable spotty coverage that I've heard about in the country. Certain companies and in certain states may be willing to cover it. I would say that universally, it is definitely not covered. None of the insurance coverage plans in Michigan will cover it, and so we have created a self-pay program, but that having been said, there are some providers in various places and working closely with insurance companies who have gotten some spotty or inconsistent coverage. It's definitely, just to follow up with that, it's definitely something that the ABE is working on. I sit on the advisory board for the Association for Bariatric Endoscopy, and many of our monthly calls are focused on how to try to get coverage for these types of procedures so that we can offer them to a broader audience. Yes, and thank you. That would be the reimbursement toolkit that the ABE just actually put together and released around the annual meeting, which was May 1st of this year. So then the next question that I have, and this is kind of a piggyback off of what the question you just answered, but are there any, endobariatric procedures that are currently being reimbursed, or if not, do you see them being reimbursed in the future? So that's a very good question. I am getting almost full reimbursement for transoral outlet reduction, which of course is the procedure that's performed in a patient who has gastric bypass anatomy who requires basically a decrease in size of their gastrointestinal anastomosis to help with weight regain, and most of those procedures were previously not covered. Over the course of the last three to five years, many of us are getting a lot more coverage. In Boston, where I did, as you heard, most of my training and most of my experience, we were getting some variable coverage. In Michigan, as long as patients have Michigan insurance, I have not had many issues. I have had a handful of issues, but for any patients who fly in or drive in to see me from other states, I have not been consistently getting coverage for those procedures. Intragastric balloons, as far as I know, are almost never covered by insurance. There's, I've heard of several compassionate uses for these types of devices, and sometimes you can get coverage as part of a clinical study, but in general, most insurance companies are not covering intragastric balloon placement. Again, we are working on this as a society, but I don't anticipate seeing that coverage in the near future. I think we are much closer to getting more coverage for endoscopic sleeve gastroplasty than we have now, which, as I mentioned, was somewhat variable and not covered at all in the state where I practice, but I think I'm hopeful and hoping that with the results of the randomized controlled trial that recently closed the merit study, which included 12 centers, I'm hoping that insurance companies will take that information and start to provide more coverage in the coming years. One thing I do, I'm sorry, one last thing is for the Aspire device, sometimes insurance companies will accept billing the PEG tube for obesity as an indication and will cover it. I think the company had mentioned to me that about 50% of their procedures are now being covered, but I can't say that with certainty. All right. Well, again, that's very good information to have since obviously reimbursement is a big part of all of this. The next question I have for you, if you are a practicing GI physician, how do you obtain certification? That's a great question. If the question is in regard to certification for certain types of devices, oftentimes those are done through the companies themselves. You can get certification for balloon placement after doing a course with Apollo Endosurgery. You can get certification for some of the advanced suturing techniques through their courses as well. The STAR programs through the ASGE also provide some forms of certification for some of these activities and procedures. Again, as an association, we are working to basically provide a variety of different STAR courses within the bariatric endoscopy realm. You'll be hearing more about that soon. Some institutions do not require a certification before actually performing these procedures. It's very important to speak directly with your institution and the leaders at your institution to determine what exactly is required. I will say certifications obviously do not equate to competence. Even after you're certified in one of these procedures, which may be the first stepping stone, it's very important that you get the clinical training and the experience with that device, some of which are very complex as we discussed, before pursuing the procedures in real time and in the real world. All right, very good. The next question I have for you, for bariatric treatment, what scope do you consider better, a single channel or a double channel endoscope? This is probably in regards specifically to the overstitch device. The traditional device uses, or the sort of the older iteration, uses a 2T endoscope. The newer SX device is compatible with a single channel scope, with really any endoscope. I think that many people would agree with me that the heaviest use users of the 2T endoscope, and the people who did the most suturing before the newer iteration of the overstitch device came out, would probably consistently say that they would prefer a 2T endoscope to do these procedures. I certainly would, and from speaking to many of my colleagues in this space, they feel similarly to me. But the nice thing about the SX device, which allows it to be expanded to 1T or single channel normal gastroscopes, is that it can be much more available to providers who may not have access to a 2T scope. That will really increase the usability of the device considerably, because you could use it in more ambulatory care centers that may not be purchasing 2T scopes, and in other busy university centers, which may only have one or two of the 2T scopes. My personal preference is the older iteration of the device, because I'm so comfortable with it. I use it all the time. I probably do about five suturing cases a day when I'm in endoscopy. But I would say that the people who have trained more recently have been trained on the newer iteration of the device, and probably are more comfortable with that. All right, that's very good. Now, the next question I have here, you may have alluded to this earlier too, but the question is, how many ESGs in general are needed to achieve competence? Yeah, so that question was answered previously, and it's a great question. It's one that we hear about all the time. So I oftentimes tell my fellows, get as much hands-on experience as you can. I think with something like this, the more the better. From Dr. Shariah's data out of Cornell, she found that really efficiency for ESG was attained after what I think was 38 endoscopic sleeve gastroplasties, but mastery not really obtained until the mid-50s. So I think, of course, again, as I mentioned, this is a single operator with experience with the device and other advanced endoscopic techniques, but it's helpful and gives some insight into the numbers. So it probably depends. It's obviously individualized like anything in endoscopy. It depends on what your experience has been with the device to date. Are you already doing hundreds of outlet revisions, and now you just want to expand your toolkit to involve endoscopic sleeves, or are you just learning the device to do endoscopic sleeves, in which case you may require many more procedures than someone who's already been skilled or experienced with the device. All right, thank you very much. That's good knowledge and good clarification. The next question I have here is from a pediatric gastroenterologist, and the question is, just curious, what age would you say is too young for endoscopic therapy, and how do you choose adolescents, or do you consider them at all? Oh, I like this. This is a controversial question. So my personal practice includes only adult patients, so patients who are over 18, or anyone who is seen in our clinic. That having been said, I'm very interested in starting to consider these procedures as maybe bridge procedures in younger patients, and I know that there have been endoscopic sleeves that have been performed on patients who are as young as, I believe, 12 or 14, and so I think it would be a decent tool for adolescents, especially if it could prevent some of the obesity that occurs in the adolescent years. So I personally am interested in expanding my practice. I've spoken with several pediatric endocrinologists and people who are very focused in pediatric GI and obesity-related issues and conditions, and people in my institution seem to be on board with the idea of starting to offer this. I think that before we actually start doing it, we probably want to have a multidisciplinary meeting to discuss sort of what that entails for, in terms of longevity, and making sure that each patient, it would be exceedingly important to have psychology services involved, and making sure that each patient understands accurate expectations, and what data we have available, and what is still to come. But I'm just starting at some of the national conferences and dedicated forums to this type of treatment and management. I'm just starting to hear more and more sort of whispers about doing these procedures in the younger population, and to me, it's very intriguing. All right, very good. The next question I have, is there any available registry for endoscopic bariatric procedures? So that's another great question, and it's one that we are also working on as part of the Association for Bariatric Endoscopy. The short answer is that there's registries from the companies themselves for these devices, and if you are doing these procedures affiliated with an FDA-approved surgical center, with the long acronym that many of you have heard, then they are keeping track of these procedures. So I submit all of my cases to our bariatric surgical division, and they're required to report them to the insurance companies and to part of this sort of national FDA-approved Bariatric Surgical Society. And so there's certainly registries that are institutional, and there's device company registries, and we are working more toward sort of the development of more national registries, so that we can keep better track of outcomes and risks and those sorts of things. All right, very good. And the next question I have here for you is, do you use antibiotics for either TOR or ESG? Great question. So when I was in my training, we did not routinely use antibiotics. That having been said, when I started at University of Michigan three years ago on faculty, I don't have a good explanation as to why I started doing this, but I started to give every patient a single dose of antibiotics at the time of suturing. There's not great data to support that this is necessary. I had spoken with other colleagues who had been doing it routinely. Some people even give short courses of antibiotics to go home with. I traditionally just give a single dose, and if there's any concern during the procedure that there may be a risk of a leak or that a suture was placed and maybe I wasn't able to cinch it and it broke, or the procedure was complex or weird or something happened that I was not expecting, I have a relatively low threshold to give just a few days of antibiotics, but I don't think that there's any data that supports that it's required. For many procedures, certainly in my training, we didn't do it, and now it seems that many centers are giving a single dose, if not a short course. So I think it would be very institutional and provider-dependent. All right. Thank you. The next question I have, it's kind of a two-part question. It's how long should I suggest a patient to hold anticoagulants or antiplatelets? And then the second part of that question is have you ever encountered gastric cancers from a fold after ESG? Oh, great questions. So to answer the first question, I, again, I work very closely with our anticoagulation team and we address the necessity of the anticoagulant and whether or not bridging is required, just like any other interventional endoscopic procedure, and then make a decision that is based on a given patient. And so the extreme example I have of this is I did an endoscopic sleeve procedure on a patient who was a heart transplant candidate and he required blood thinners for a variety of different reasons. And we felt that the risk of him stopping them was really too high to not bridge him. And so we actually elected, because he was so sick, to admit him to the hospital and to bridge him while we watched him closely with heparin. And then to stop it, I think it was four to six hours before the actual procedure. And then we actually kept him in the hospital for a day or two after. And with the thought that even if we reinitiated it and he bled, we could still intervene on that. But the risk of him having a major cardiac event was not inconsequential. And so for him in particular, we had a very sort of conservative approach. That having been said, I've had several other patients who I have just stopped their anticoagulants in the same order as I would have for any other endoscopic procedure that requires stopping. So five to seven days for Plavix or for Coumadin, depending on their INR. And then depending on the procedure, it dictates to me when I restart them. So ideally, you wait three to five days after. But if they're very high risk, again, I would feel comfortable starting as long as they understood the risks of restarting. And this is speaking specifically to endoscopic sleeves or plication techniques. With intragastric balloon therapy, many patients can actually continue their blood thinning medications during therapy. You just have to make sure that they're maintained on PPIs. And I usually test everyone for H. pylori and those sorts of things. That reminds me of the second question one more time. It was about gastric cancers performing after ESG. So that's a great question. I have never seen that happen. It's obviously a theoretical concern. And so for every patient that I consider for endoscopic sleeve, I make sure that I test them for H. pylori. And if it's positive, we treat them before the procedure. And I also exclude anyone in my clinic who has a family history of gastric cancer. And it's for that exact concern. Because we think that even though we don't know that the procedure will necessarily last a decade, but we think that these and we know that these sort of tissue bridges form that may close off certain access points to various places on the greater curvature. So I am relatively conservative with that in that if a patient has a family history of gastric cancer, I will not perform an endoscopic sleeve. All right. Thank you. We do have lots of good questions coming in here. And we still have a little bit of time. So the next question I have for you is reflux post ESG less common than in surgical sleeve gastroplasty? Definitely. So there I would point you to a paper that came out of Hopkins with one of my colleagues, Dr. Vivek Kumbhari. His group looked at basically the differences or the outcomes between endoscopic sleeve and laparoscopic sleeve. And what we know is that reflux from strictures and other things following laparoscopic sleeve is exceedingly common. Interestingly, following endoscopic sleeve, it's almost non-existent. So we have a very robust program at University of Michigan, and many, many people enrolled, especially over the last few weeks. I think we've enrolled close to 20 over the last three weeks for endoscopic sleeves. And I have yet to see a single patient come into my clinic complaining of reflux. All right. Good. The next question I have for you, which centers do we look into for dedicated training in bariatric endoscopy for practicing advanced endoscopy GI attending? So that's a great question. So I think the question was, which centers should you look at to get dedicated training? So there's a whole slew of different centers that have experts who can help you sort of work through what training is involved and hopefully get you some hands-on experience. And certainly a lot of observerships where you can come in and watch procedures for several days or weeks or months. You're welcome to email me and let me know sort of where you are located, and I can try to connect you with someone locally. There's several people, there's several surgeons who do these, and there's also several GI-trained endoscopists who do these types of procedures. So it very much will depend on sort of where you're located and what your interest and background is. But we could connect you with people who we know who are doing these nationally. All right. Well, thank you very much. The last question I have for you, will there be an ESG STAR course? Great question. Yes. So we are in the midst of developing the curriculum for that course. And so we are hopeful that things are moving along quickly. And that is through the ABE, the Bariatric Endoscopy Society. Yeah. And if I can, I'll just chime in on the ESG STAR. The Bariatric STAR course at ASGE is on the schedule for 2021, and it's probably going to be in Q3 or Q4 of next year. So you'll want to watch the website for that. So I want to thank Dr. Shulman very much for this great presentation and all the information that you have shared with everyone. We really appreciate it. I also want to thank everyone who attended the webinar this evening. And I hope this information is useful to you and your practice. Just a reminder, there will be a recording of this event and it will be available in ASGE's GI Leap, which you will have access to as part of your profile for registering for this course. This does conclude our webinar for this evening. Please visit the ABE website, which is www.barriendo.org for a list of upcoming educational opportunities from the ABE. Thank you again and have a very good evening. Thank you very much.

Bariatric Endoscopy

Dr. Allison Shulman

Obesity

Training Requirements

Endoscopic Therapies

Patient Selection

Interdisciplinary Approach

Online Materials

Multidisciplinary Team