And I'm going to quickly do some introductions before we get started. To introduce our speakers, we'll start with Dr. Shelby Sullivan, who made it up to the podium first. So she is a bariatric endoscopist and the Director of Bariatric and Metabolic Therapy in Denver. Next is Dr. Bara Maboudaya, who's a Professor of Medicine at Mayo, who's also Vice Chair of Innovation in the Department of Surgery and the Director of Interventional Endoscopy there. And then last but not least, Dr. Chris Thompson, who is the Director of Endoscopy at the Brigham and Women's Hospital, who's also a Professor of Medicine at Harvard Medical School. And so I thought we would start with a brief case that is very common for all of us in our practices. So this is a 57-year-old woman with a history of hypertension and a recent diagnosis of type 2 diabetes and class 2 obesity. So she has a BMI of 37, who's presenting to our clinic interested in options for weight loss. She's tried numerous diets and exercise programs, usually only with about a 5 to 10 pound weight loss without any really durable lasting success. She reports occasional reflux, maybe one to two times a month, but it's well controlled on daily proton pump inhibitors and denies any prior surgery. And so this is a classic case. We all see this in our clinic very regularly. And so I just wanted to use this as a kind of a launching point for a discussion with our panel. So starting with Dr. Sullivan, how do you approach patients like this in your clinic? And specifically, do you recommend weight loss medications initially before discussing procedural options, or do you discuss all options at the time of your first visit? Can we pull up? Yes. So this is what I really recommend, and this is what I do in my clinic, which is really shared medical decision making. Some patients will come in with an idea of what they want, and some patients really don't know exactly what they want. So one of the things that I really try to do is tease out based off of their characteristics, their patient characteristics, other potential disease processes, and then also what their level of risk acceptance is, what their level of acceptance is of something that is potentially less reversible, and whether or not they're willing to be on a medication long term. So some people come in and they'll talk about medications, especially now with Wegovy being approved. We've had Azempic for a while that's been approved for diabetes, not for weight loss indication, but for diabetes specifically. But what's really important for patients to understand with medications is you cannot stop them. You will have to be on medication for a long period of time. So I kind of group these, and these were some of the more salient things that I talk to patients about in terms of what kind of weight loss can they expect with these different therapies? What kind of weight loss maintenance can they expect if they stop the therapy, like if you take out a balloon versus stopping a weight loss medication? Is it covered by insurance or not covered by insurance? Is it repeatable? Could you do it again if you wanted to, like a balloon? It's a repeatable therapy. Balloons are completely reversible. You take the balloon out, everything goes back to normal. If you do an ESG, is it reversible? You potentially can go in and cut some stuff, but there's going to be scarring there. So your stomach is never going to be normal again, essentially. It's never going to be completely back to normal where it would be after a balloon. The other things that we talked about are some of the side effects things. So if patients have, if they start out with poorly controlled GERD, balloons might not be a great idea. If they've got a family history of thyroid cancer, you want to stay away from a GLP-1 receptor agonist. If they've got a history of pancreatitis in the past, if they already have gastroparesis. These are all things that go into the shared medical decision making that you have about your next step for procedure. But I definitely would not require a patient to be on a medication before they get a device or procedure. Excellent. Thank you so much. And kind of as a follow-up question to that, the newer GLP-1 agonists obviously are achieving very impressive weight loss. How do you expect that those will impact your own practice and do you have any reservations about offering those to your patients? I don't have reservations about offering them, but I do have a frank discussion about a couple of risk factors. We previously thought that thyroid cancer risk was a theoretical. So we recommended for patients who have a family history of thyroid cancer or in the end too, that they would not go on these medications, but as it turns out, it's not a theoretical risk. It is a real risk. There was a paper published in November that was a large epidemiologic study that demonstrated this and it's both medullary thyroid cancer and papillary thyroid cancer. So we discussed that that is a risk, even though your risk is small, this increases that small risk. And then we talk about the other potential side effects as well, and that they have to stay on it for a long period of time, which can be a problem because these medications are very expensive. So if your insurance company covers the medication, that's great. If you change jobs and your insurance changes, you may not be able to get that medication. The other thing that's important to note is that what we're finding is that insurance companies are now requiring us to get prior authorization every six months for these medications. So it really causes a problem in the office, just the amount of time it takes to be able to prescribe these medications. Yeah. Excellent. Do either of the other panelists want to comment on either of those questions? Otherwise, I'm very thorough as always, we'll move on. Dr. Thompson. So this is a patient with class two obesity, her BMI is 37, and also a comorbidity. So she would technically be a surgical candidate. Can you comment in your practice, do you refer all these patients to see surgery? Or how have you built your practice at the Brigham? Yeah, so, you know, most of these patients, you know, end up in our clinic because they don't want surgery, they've already thought a good deal about it. We currently work in a multidisciplinary center, so the surgeons are there. So sometimes I'm better at convincing patients that they should have surgery. So I'll try oftentimes, if I think they're a better surgical candidate than a, you know, than an endoscopic one. And fortunately, a surgeon's right around the corner, so I'll just grab them and bring them in. However, if they've already thought a lot about it, they had a loved one with surgery, I'm not going to make them go through that again, it's disrespectful. So if they really thought through it, then we don't we don't make him do that. And we never send him for a second visit. Yeah. Perfect. So, Dr. Abudaya, this particular patient, kind of similar to what Dr. Thompson had mentioned, had a close friend who had had a gastric bypass, several complications from her gastric bypass, and was not interested in surgery. Can you walk us through what endoscopic options are available to her currently? Well, in the US, there's only two options. It's either a intragastric balloon, which or the endoscopic sleeve gastroplasty. And the one on label for the endoscopic sleeve gastroplasty is with the overstitch system from Apollo. So I would give both options for the patients, but in this particular case, I'm hesitant to offer the intragastric balloon, at least the fluid filled intragastric balloon, because she has, number one, diabetes, so she might have some gastroparesis there. And number two, she has reflux, which could be exacerbated with the fluid filled intragastric balloon. So although I would present that option, I would steer the patient toward a gastric remodeling procedure, namely the endoscopic sleeve gastroplasty, because we have reasonable evidence from level one, from prospective trials, that GERD, at least symptomatically, does not get worse. And that it has favorable impact on type two diabetes because of the degree of weight loss. Now, that could be mostly mediated by weight loss, but there's some theories that it could be also some weight loss independent effect through modulation of some gut hormones. Great. Anyone else have a different opinion or the same opinion? Well, I agree with the concern with balloons and reflux. I would definitely prefer an ESG. Additionally, ESG can pull that esophagus down, so you elongate the intra-abdominal esophagus, kind of re-limiting what reflux you have. And that is the only one that's currently on label for weight loss, but keep in mind that was just recent. We were doing ESGs for a decade before. So there's some other devices to their placation platforms that are newer, that are seeking approval that hopefully will be more widely available soon as well. Great. Anything, Dr. Sullivan, that you want to add? I would just add one other thing that, you know, in this potential patient, you know, she has reflux, she has type 2 diabetes, could have some component of gastroparesis. Anecdotally, in patients like this who even have, in my experience, known gastroparesis, because one of the concerns is, well, if you've got, and if you do an ESG that potentially may cause some delayed gastric emptying as well, will this make their symptoms worse? In my experience so far, it has not. One other thing, you know, yes, class 2 obesity, they're bigger, but there was data out of Brazil that showed bigger people lose more weight, Spain, and now Barham, senior author, I think, on a multi-center international study with a lot of patients, I don't know if it's a thousand or something, they show the bigger you are, the more weight you lose. So that's not something that really gives me pause. It's surprising, Chris, right? We always said 30 to 40, but the best performers were above 40 actually, which is more to tell about the story. Yeah. Very surprising. Yeah. Yeah. Excellent. So we tried to convince this patient to undergo a gastric remodeling procedure for all of the reasons that you all just commented on. She was very fearful of this. And so she ended up choosing to undergo a balloon placement. She lost about 46 pounds at the time of her balloon removal and her BMI decreased to 29. However, over the course of the next year, she began to gain weight and was kind of interested in next steps for weight loss. So Dr. Sullivan, can you just kind of walk us through how you manage patients who elect to undergo balloon placement? What tests do you perform ahead of time? What medications do you prescribe? What do you keep going while they're undergoing balloon placement? And then also, what are the major complaints that people will see in their offices with this? So again, currently, as Dr. Abadaya pointed out, we only have the fluid-filled endoscopically placed balloon. So that's a little bit different workup than a swallowable balloon, but we don't have those right now. So we'll kind of forego discussion on the swallowable balloons until they become available to us again. But I do an evaluation for pre-procedure for a balloon. I do check for H. pylori status because they can get ulceration and that can be worse with balloon in place if they do have H. pylori, and then would make sure that they're... While it doesn't necessarily improve their outcome with the balloon necessarily to check labs, I always do an assessment of medical comorbidities, and I do that just for every patient with obesity, regardless of what therapy I'm putting them on. Patients with obesity tend to also have vitamin D deficiency, so that is another vitamin that I will check. You may want to check some other things as well. In terms of what I would do for a patient who as they're progressing through their therapy, if somebody has not lost at least 5% total body weight loss by the time they come in to see me for my one month appointment, I would consider adding a weight loss medication at that point. If we haven't added a medication before they have the balloon removal, we have a discussion about that in an appointment just before balloon removal to talk about adding a weight loss medication that can help maintain their weight loss longer term. We have data, multiple studies now that have supported that, that there's less weight regain if we have weight loss medications that are on board afterwards. The other thing that we can also consider, if they did well with the balloon, they tolerated it well, had success with the balloon, you can always think about repeated balloon therapy as well, or going to something else. Yeah. Perfect. Thank you. And I'm glad you commented on the medication component as well. I think we're seeing more and more studies certainly that have been presented at this year's DDW that there's some synergy and synergistic mechanisms potentially that would augment weight loss. So, Dr. Aboudaya, if this patient elects to undergo a gastric remodeling procedure, what can she expect in terms of her weight loss? And do you think that the procedure has any potential to improve her high blood pressure and her early diabetes as well? Yeah. So, it's an interesting case, and there's a couple of important nuggets to discuss here. One is she was a good responder to the endogastric balloon, and we know one of the dominant mechanism of action of the fluid-filled gastric balloon is delayed gastric emptying. That means she responds to this pathway of delayed gastric emptying. So that makes me favor that we could convert her to something that works on a similar pathway, but it's more durable, which is the endoscopic sleep gastroplasty. The second important point is she had a fluid-filled endogastric balloon that we know that increased the thickness of the stomach. So that is in consideration. We know that thickness decreased back in three months after balloon removal. So if I'm going to offer her an endoscopic sleep gastroplasty, I tell her, you're a good candidate for it because you responded to the balloon, and now the endoscopic sleep gastroplasty is not only going to work on emptying, but also on the accommodation of the stomach. So you add a new pathway to it, but I will tell her that we're going to delay it by three months and that three months will do the endoscopic sleep gastroplasty to allow me to do better job getting full thickness sutures for a more durable response for that patient. So yes, I would offer her a gastric remodeling, and her chances of type 2 diabetes and hypertension improving is quite high. We know that from the MERIT trial because weight loss to the degree of 15% or more is associated with high percentage of remission or improvement of type 2 diabetes and hypertension. Thank you. And I know we're running short on time, so I want to finish up with a quick question for Dr. Thompson. So you're always kind of looking for the next steps into the future, how we can innovate. Take us there and let us know, where do you see kind of the future of this field in regard to the treatment of obesity-related comorbidities such as diabetes or NAFLD? Good point. So there's, you can expect a one-point drop with balloons or with ESG, which is, you know, good. However, you know, with gastric bypass, you're getting more. So there's small bowel mechanisms that are quite important, and that's a long conversation for gut, hindgut, and the different gut hormones. But there are several companies that are working on these kind of foregut concepts, whether they're ablating mucosa or affecting the kind of neurohormonal access. And I think that combining those with a gastric procedure is probably, you know, a good start when we think about the future and what we can expect to see in treating people with diabetes. Awesome. Thank you. So next, I'm going to have Dr. Abudaya come up and give us his lecture on challenges and encounters with balloon and ESG.

panel discussion

obesity management

weight loss

shared medical decision making

weight loss procedures