BTK Endobariatrics Audio

Welcome back to another episode of Behind the Knife. This is our second episode in the Surgical Endoscopy Series. In this episode, we're excited to talk to you all about endobariatrics. So I'll start with a brief reintroduction of team members. I'm Sully Yuso. I'm a current minimally invasive surgery fellow at Endeavor Health in Evanston, Illinois.

Once again, we're lucky enough to have Professor Michael Ujiki and Dr. Mason Hedberg from Endeavor. In addition, we're joined again by Dr. Trevor Crafts, who is an alumnus of the program here and is with us from the Rocky Mountain VA in Denver today. We were lucky enough to have a special guest with us as well.

This guest is Dr. Brian Duncan. Dr. Duncan is a surgeon himself, is a surgical endoscopist, and is the chief medical officer currently at Boston Scientific. So we're very thankful that Boston Scientific has helped support our efforts in the development of this six part series. And Dr. Duncan, we welcome you to Behind the Knife.

Thank you. Really

appreciate the opportunity to be here. And I'll have to say it's an honor for Boston Scientific to be able to support this kind of discussion. You know, we're, we're a company that Endeavors to supply endoscopist with the best tools possible to take care of their patients. That's both from the GI and surgical standpoint.

So it's really great to be here. Thank you again, Dr. Duncan. I'm Trevor crafts is a solely mentioned and kind of before we dive into the data on bariatric endoscopy and the technical nuances of these different procedures. I think it's worth providing a big picture overview of this topic. For the purpose of our talk today, we'll focus on the most common and well studied of these.

So, First and foremost, endoscopic sleeve gastroplasty or ESG then endoscopic GJ revisions or transoral outlet reduction. So that's for acronym purposes, EGJR or TORI. And we will also briefly touch on intergastric balloons. So endobariatrics or bariatric endoscopy has been in existence since the mid 1980s when bariatric balloons were first introduced.

These were initially air filled

polyurethane balloons. However, early balloons did have noted complications and unsatisfactory weight loss overall. And these early versions were eventually pulled from the market, but have evolved in iterations to be the three or four devices we have today. The next big advancement took place in the early 2000s when novel platforms allowed for endoscopic suturing.

And from there, an evolution of devices and suture patterns took place in order to get ESG in its current kind of modern form that we think of. In our practice, we've seen an increase in the demand by both referring practitioners and patients for these types of procedures, as there are more data gathered showing that patients can achieve meaningful weight loss without the need for incisions.

With greater visibility in the medical community, more practitioners being trained in these techniques, a new CPT code in the case of ESG, access for patients is increasing as well. And even in this new era of promising pharmacologic therapies for obesity endobariatric procedures are increasingly being highlighted.

Take ESG as a comparator, for

instance, as a standalone intervention, there can be a cost benefit for a one time low risk procedure. And alternatively, it can be used in tandem with these medications to further overall weight loss. So endobariatrics is an exciting frontier for obesity treatment, not only because of the new studies being done currently, but also because of what technologic possibilities could come to market down the road.

But I'm kind of getting ahead of myself in our discussion here. So slowly back to you. Thanks Trevor. I appreciate it. Dr. Yujiki, I want to go to you next. This is topic that I know that you're very passionate about. And I feel like at least in our clinical space, it seems like what most of what we're doing almost from a procedural standpoint in the bariatric realm right now, so love to hear your perspective on the topic and how things have evolved from when you started doing the procedures now almost a decade ago.

Well, first of all, thank you Sully for emceeing this and I, I would like to echo that we're very fortunate to have Brian Brian was actually someone I looked up to when I was in fellowship and finishing fellowship as

a surgical endoscopist and that was about the time that I started my career in 2008 you know, notes surgery was, was really being looked at very closely.

There were actually human cases being performed. And as part of that, the instrumentation that was needed for us to be able to perform these very complex procedures, in particular suturing endoscopically in order to close defects, was at the top of everybody's list. And Again, we were very fortunate that there were a lot of companies and industry that were, were helping us develop these instruments.

And so I, I've really been interested in, in weight loss, endoscopic weight loss surgery. Since that time, we started doing revisions in 2008, actually in 2007. And we use a lot different instrumentation that Then what we have now, and we learned a lot that instrumentation is certainly evolved and become much easier to use and much more

effective.

And we're now at a point where we have very good devices that can really. Restrict and narrow the lumen of the stomach, for example, whether it be in a revisional situation or in a primary weight loss situation. And so the instrumentation is really what's made it possible. We're very grateful for companies like Boston Scientific to not just develop this instrumentation, but also to educate us on how best to use it.

And I will say over and over again, Boston Scientific is outstanding. And a lot of things, but one of the best things they do is educate us proceduralists on how to do things safely and well. So we're, we're at a place now where we can perform things like an endoscopic sleeve gastroplasty and achieve almost the same amount of weight loss as surgery.

As a matter of fact, more weight loss in some surgical procedures. And, yeah. The benefits are clear without incisions. There's less, the

complication rates are lower. The recovery is much easier. So rather than going back to work in two weeks after a one or two night stay in the hospital, we're sending people home same day and having them go back to work in a day or two.

And, and so it's really a game changer in that way. And so, I, I also think that patients, there's a perception out there, not just by patients, but also by referring physicians, primary care physicians in particular, that bariatric surgery is not safe. And we know that's not true. But the fact of the matter is, about 1 percent of patients who actually qualify for bariatric surgery are actually having surgery.

And so I think that, In many ways, the access to a life changing procedure that really will lead to better quality of life, we know longer life we know, and, you know, is limited. And, and I think that procedures like endoscopic procedures

that patients really view as more appealing is increasing the access you know, and making people healthier.

So I think it's not just the benefits of shorter recovery, less complications, but also actually increased access. You know, we're filling a gap, if you will and, and providing a procedure that patients and primary care physicians are more likely to benefit. to agree to do or want to do. And we also know, by the way, that a patient is about five times more likely to undergo a procedure if a primary care physician supports it.

And so I think it's not just, you know, the patient's perception, but also our referring physicians. And I think our referring physicians are very clear that they, they You know, they feel that this procedure is safe. They want to do it. The other advantage is the This procedure though in you know in all the years i've been doing bariatric surgery I've never been asked to reverse it is a reversible procedure, which I think is appealing to some people so you do have a very safe procedure that

is potentially reversible and and so there's those are the benefits that I can think of Wonderful.

Dr. Duncan, I would love to get your perspective on this as well as a, both a physician leader and a leader in industry talking about the evolution of technology in this space, but also, you know, patient comfort, which is what Dr. Yujiki started to allude to and how patients have become more comfortable with these procedures over time.

And in some cases, actually wanting this is the first option. Yeah, again, thank appreciate the opportunity to say a few comments that, you know, the, the comment about notes procedures is, is relevant here because the device that we manufacture the overstitch device, which is used for endoscopic sleeve gastroplasty ESG.

We acquired that technology from a company called Apollo. Apollo started as a notes working group. It was an industry sponsored group. It was leaders in both surgical endoscopy

coming together and they were thinking about how to solve problems for more advanced and illuminal procedures and they landed on suturing that they needed to be able to close holes.

That's kind of a foundational element of surgery. We make holes and then we close them. And so, that led to the development of a device called Eagle Claw. And then that eventually led to the development of the company Apollo and a couple of the original group helped found that company. And then the rest is history as they evolved that technology both for use in endoluminal surgery as well as endobariatrics.

And then eventually we acquired that technology about a year and a half ago. So it's been exciting to see this evolve. I actually used the first. prototypes of from Apollo since I was working in Texas at the time and Apollo was headquartered in Austin. And by Texas standards, a drive from Houston to Austin is just down the street.

And so we we had a

opportunity to collaborate together and was one of the first to use it in, in people to manage some complications like leaks and fistulas. I'll say that as a company, the way we're thinking about endobariatrics is that this is a gap therapy, which gets at what Dr. Ajiki just talked about.

You know, if you think about it, up until just a couple of years ago, if I was a patient suffering from obesity, I really had two options. One was lifestyle modification, which virtually every obese patient has tried in some form or fashion. They might, it might not be medically supervised, but everybody that's overweight or obese has tried some kind of lifestyle modification to manage their disease and universally it has failed.

In fact, if you look at the very good data, the durability of lifestyle modification over about five years is maybe 3%. So

if so I had lifestyle modification and people were pessimistic about that because they've tried it. The other was surgery. And again, as Dr. Ajiki said, the bariatric surgical community has made surgery for obesity one of the safest operations a person can have.

But it's surgery. And many patients have basically spoken with their feet to say, we don't want to have surgery. Actually with new guidance, less than 1 percent of patients in the U. S. that are eligible for bariatric surgery actually choose to have it and then go through with it. So we needed something in between.

GLPs came along and they're effective and they'll continue to be effective. And so they're helping many people and And actually they're helping the whole management of obesity because now patients are reengaging with the health care system to hear about a new option to manage their obesity.

And that for many of them is a GOP1.

So they're engaging again, they're getting advice about what their options are, and many of them are starting on that medication, and many of them are going to have success. But I'll tell you that a lot of them will look for another alternative that's not surgery, it's not pharma, and it's not lifestyle modification.

That's where this procedure fits in. And in fact, data published just last month in JAMA Network, Rodriguez and others, 56%, I believe it was, Of patients that started GLP one for the purposes of losing weight, are off of that medication at 12 months. 72% are off of it at 24 months. So there's a large cohort out there that will be looking for an alternative.

Hopefully they've had some success with other alternatives like GLP one and they'll be looking for an alternative. That's where we feel the ESG

fits in as a gap therapy between. lifestyle modification and pharma and surgery. And unfortunately, because there's such huge disease burden out there, there's a lot of patients that this will be an excellent solution for them.

And so that was, that's what gets us excited at Boston Scientific about getting into this space. If you look at the space from a company standpoint, or I should just say at the health care field from a medical device company standpoint, one way that we increase our impact on the health care community and the physicians and patients that we serve is by entering into what we call adjacent markets, things that are next to what we already do.

But, but aren't what we do now. And we feel we can have a positive impact. Bariatric endoscopy is a field that we've been looking at for a long time in the endoscopy division at Boston scientific. The overstitch of device from Apollo gave us the right

device. The data around that gave us the right support.

And so that's what allowed us to get into this area. And to be able to impact a disease that's, that's that over 40 percent of Americans are suffering from an obesity, that's a real opportunity, which, which drives us to want to work in this space. That's fantastic. Dr. Hedberg, you want to kick off the conversation about endoscopic sleeve gastroplasty including some of the tips that you have offered me and others on the surgical technique, procedural technique.

Yeah, absolutely happy to do so. So ESG, you know, we can consider it now the gold standard primary weight loss intervention that can be done endoscopically. The first big trial evaluating it was the merit trial and we were at Endeavor, we were one of the participating sites. So several of the 209 patients in the study were operated on by Dr.

Yujiki. This was published in the Lancet in 2022. It was organized as such that half the patients got their ESG

immediately and the other half just did their lifestyle modifications. The ESG group was also doing the same lifestyle modifications, or just evaluating the ESG itself. And then the other group of patients did get their ESG eventually.

And these are all patients with class one or two obesity, not class three. After 52 weeks, there was 50 percent excess weight loss for the ESG patients and only 3 percent for the control group. As we discussed that 3 percent number is kind of persistent looking at lifestyle modifications and about 70 percent of the patients in the ESG group maintained 25 percent or more of the excess weight loss at 104 weeks.

And we did see good weight loss maintaining through essentially the five years throughout the study. And we did see as well, 80 percent of patients in the E. S. T. Group did have some metabolic improvements, which is what we like to see with our laparoscopic procedures. So the procedure itself has changed quite a bit since it was first described.

And Dr J. K. Remind me if I'm incorrect here, but I think when it first was being done, we were kind of just

approximating the anterior and posterior walls of the stomach along the greater curve, kind of flattening it out. And then that evolved into these triangular stitches kind of Doing the anterior greater curve posterior trying to again kind of tubularize that area better And everyone agreed on a new technique for the merit trial, which was very helpful So it's all consistent, but that's where we started doing these u shaped sutures a little bit hard to describe with audio, but you start suturing on the anterior wall of the stomach and then move out towards the greater curve, then out down back towards the scope posteriorly, and then you move superiorly towards the G junction and go back up towards the anterior wall of the stomach.

So you're taking a probably about five or six bites moving down and then back up. So, you know, 12 bites or so with one suture. And then when you cinch that down, it kind of accordion folds. The whole greater curve of the stomach. So it's more effective in terms of tubularizing the lumen rather than leaving these kinds of gaps where things can get collected with the

previous techniques.

It's hard to get the stomach quite as small as a laparoscopic sleeve. You know, the, the dual lumen scope we're using is essentially the same size as the bougie we put down for a lap sleeve. So you can't quite get it as tight. But you are trying to get a very generous volume reduction of the stomach.

There is some debate on how to handle the fundus. So, you know, you can imagine pulling on the greater curve with these accordion folds could cause some tension on the short gastrics there. Or if you happen to puncture one of them directly with the needle, that could cause some bleeding. There are case reports of an abscess out by the spleen after this procedure.

So the company actually recommends Pretty much avoiding the fundus. We like to try to collapse it to some extent. I try to avoid the greater curve with the suture itself. I kind of collapsed the AP dimension. And I've heard of another doctor actually kind of excludes the fundus kind of so in that area closed right past the junction.

So there are a couple different techniques that to address the fundus. But in general, we try to collapse it to some extent.

I'll say we do have a video that will accompany us so you can see some of this what I'm talking about, but Dr. Ujiki, do you have any thoughts on the fundus or anything else in particular, how the procedures evolved over time?

Well, I think the fundus is thin and thin walled, and I think one does have to be careful in that area. You know, there's some studies that are not necessarily randomized, but retrospective studies looking at whether or not the fundus is placated or not, and really didn't show any difference in weight loss, but there was an increase in complication.

So I do, I do think that in general, you should be careful to fund this. I do think that you know, they're, they're. still, you know, experimental in some ways. I think the important thing is that different than a surgical sleeve where we tend to improve or make more rapid gastric emptying, the endoscopic sleeve actually works in a different

way.

And in that very merit trial that you're taught that you talked about, there was a subset of patients who agreed to go through some further testing that included gastric emptying studies, as well as looking at some of the hormones that have to do with both satiety and hunger. And it was interesting to see that the gastric emptying slowed by almost an hour.

in the group that had endoscopic sleeve. So that's kind of the opposite of what we see with a lap sleeve. And it probably has to do with fundus accommodation. You know, in a laparoscopic sleeve, we take the fundus and we probably make more rapid gastric emptying by doing that. But when we leave the fundus, we act, the fundus accommodates any food in there.

And we get a very similar result in that we do affect the hormones that make us feel hungry and make us feel satiated in, in, just not quite as much, but, but we significantly change those hormones with an endoscopic sleep, but in a different way, that fundic accommodation. So I think a lot of surgeons, including

myself, feel very strongly that the fundus is something that we need to address when we do weight loss surgery.

But there may be a different mechanism here. And so I think safety is first. And I do think that the fundus when you know, especially people that are out there learning or starting for the first time, I think the fundus should be avoided. I do think that there's some opportunities to perhaps do further research and look at it.

Yeah, that's great. Thanks. I actually had a patient asked me if I do the ESG max. I had no idea what she was talking about. I had to look it up, but there's a group running a trial now where they're ablating the fundus before doing the ESG. So I'll be, that'll be interesting. I'll stay tuned. The one thing I forgot to mention while describing the procedure, there's some variability on whether you do a preoperative endoscopy for laparoscopic surgeries.

We do that here. I think part of the reason is you don't want to cancel a case after you've opened all the equipment and everything. For the ESG, we do not, you know, we don't open anything until we put the scope down at the beginning, make

sure there's no reason not to do the procedure. So we abandon the preoperative EGD for these.

One other thing that I think is interesting. The first ESG I ever did on my own, put the scope down and there was a four centimeter hiatal hernia. So I actually called Dr. Ujikia and said, what do I do? He said, well, in the merit trial, four centimeter was the cutoff. So it's okay to do these procedures when there's a hiatal hernia present.

The GERD doesn't seem to be a problem even when there's a hernia. So that's one thing that's a little different than when we're doing our laparoscopic procedures. Dr. Duncan, did you have something to add? Yeah, just a couple of comments. So, first of all, about this discussion around preserving the fundus or not, and there was a comment made about a recommendation from the company.

So, everybody should know out there that as part of the FDA clearance for using overstitch for creating an ESG they put in place what's called a special control these are done commonly when, when they want, when

FDA wants something extra to accompany this clearance and the special control was an educational initiative and that mandates the company.

That's Boston Scientific now. To provide training for anybody who wants to use overstitch for the purposes of creating an ESG. And so we've developed a very robust training program to accommodate that, that we think is world class. And in that training, we do advocate for not suturing in the fundus.

And, and the reason we do that is for the safety reasons that Dr. Ajiki just mentioned. It's a, it's a thin walled part of the stomach. It's close to the shed short gastrics. And you want to avoid complications. And I just want people to understand that we teach a course that is meant to allow people early in their learning curve to adopt a safe and effective procedure.

And so that's, that's when you want to concentrate on the right suture pattern. And you heard about the U shape

described, you want to concentrate on the right number of bites. And you heard, you know, 12 or more in that one, you suture that's being applied. You want the right number of sutures. And we advocate for a minimum of six, preferably of eight.

We really want a a durable construct here that's effective. And we, and, and all of us want to take care of this procedure. This is a relatively new procedure. Endo bariatrics beyond balloons is a relatively new field. And we all have an obligation to do the best work possible and create the best construct possible.

And couple that with good care so that this field flourishes and doesn't go away. And so I just want to emphasize that training component because it's Full thickness bites you stitch six to eight or more. Multiple bites during that and I would advocate strongly that if you're early in your learning curve preserve the fundus and and then we can discuss Nuances beyond that once you

get further down your learning curve.

That is an absolute perfect transition into the kind of next bit which I will take the lead on I think dr Yujiki told me something one of my first days of fellowship. He said that The ESG procedure was the best way to learn how to endoscopically suture. At the time that was a little bit confusing to me because I, I view this as somebody that didn't have much experience as kind of one of the gold standards in terms of the complexity of the endoscopic suturing that needs to be done.

But I think he's absolutely right. This procedure has been the most fun one for me to learn this year. And I think because I've seen more rapid progress than in other areas. You're taking, you know, six to eight sutures. You're doing you stitches several bites. You're learning the feel depending on the device that you use.

But one of the most important, you know, parts that we haven't touched on necessarily is the importance of getting full thickness bites. So Sarosa to Sarosa there are different devices. The main one that we use is the overstitch device. So that is framing

the context for most of our conversation today.

But we actually use a tissue capture device to pull tissue into the endoscopic suturing device itself and then take a bite through that. A lot of the nuance for ESG actually comes based on the feel. So you want, you can feel when you're getting a full thickness bite. One of the previous fellows in our program called it the Polish Pop.

And so that's kind of what we colloquially refer to it as, as such. But the other thing is when you use a tissue capture device that can be a a dangerous instrument as well because you're getting you're basically penetrating the tissue and can go into the peritoneal cavity. So, you know, we don't know what lies on the other side because we're not doing this procedure with laparoscopic assistance, but you can tell the more that you do this procedure when you're getting too much tissue and when that's the case, you, you know, would like to undo the tissue helix device so that you're not potentially getting omentum or another solid organ that can could lead to a potential complication.

Dr Jiki, I know you've been doing this for,

you know, several years and you've had few, if any, complications with this. But every time I do one of these, I think about how this is the most devastating potential consequence of this procedure is being aggressive with that device and not knowing necessarily what's on the other side of the stomach.

Any comment on that? No, I, I think if you, you said it all correctly the helix is probably the, the one instrument that you really need to make sure that you understand how to use it correctly. And I think that Boston Scientific has been working on you know, even better helix devices, new generation ones that are even safer.

So I, I think it'll become less of an issue in the future, but yeah you, you definitely need to train on this and you need to understand. You know, that, yes, full thickness sutures are the only way that this is going to work well and be durable, but in order to get full thickness sutures, you, you also don't want to, you know, be putting the helix device through the stomach and grasping other organs.

So, you do have to be safe.

But having said that, yeah, I've been doing. some form of these endoscopic procedures since 2008 with this particular device since 2016. And I've done, I don't even know how many, too many to count. I've really only had one complication. And, and it was a complication that was just an infection around the stomach that was easy to treat and the patient did fine ultimately and actually had decent weight loss and improvement in her diabetes and but so it's a very low complication rate procedure.

But again, you have to know how to use the tools correctly and safely. Wonderful. And I think, you know, one of the things that we've reiterated on both of these episodes is that they're a certain level of baseline proficiency and endoscopy are going to make these other procedures easier to perform. And so we, you know, take pride in doing, you know, both preoperative, for our patients.

I really believe that it makes performing more advanced procedures a little bit easier since we're, you know, doing these things every day. day. As Dr. Duncan alluded to,

there are coursework or courses out there that help to teach both trainees and practicing surgeons how to perform this procedure.

We're actually going to host one next at the end of this month that's in part sponsored by the American Foregut Society. So this is something that you're interested in, even if you're in practice, you know, be on the lookout to, to learn these new skills. But with that said, Shreve, you want to take it with the intragastric balloon placement.

Absolutely. Thank you. And so, as mentioned, we'll kind of pivot and talk about intergastric balloons at least briefly. We won't spend quite as much time as, as we did on ESG, but they do occupy certainly an important niche in the spectrum of bariatric therapies. There are multiple loons. Balloons that are available, including those that are saline or gas filled balloons and balloons that are placed either endoscopically or swallowed as a capsule.

Looking at the data on these can be a bit disorienting. Not only do you have products that are technologically different from one another and have come and gone from the market, but there are variations in treatment practices based on balloon fill volume, how many balloons are used,

how long they're left in, etcetera.

Meta analysis compilation puts excess weight loss for balloons at about 18%. You know, barring all of those different factors we just mentioned. And interestingly, not only are there randomized control data for intergastric balloons in general, but this is actually one of the instances in surgery where there's actual sham control arms in some cases, which is just something we don't encounter as much elsewhere.

However, to kind of focus in on one as an example, probably the most commonly encountered product is the Orbera balloon and in full disclosure, I do believe that's now a. Boston scientific product. But I don't mean that as product placement. Rather, it's just something that people are likely to encounter on a day to day basis as bariatric providers and is also well studied at this point.

So or bear has been on the market or at least been FDA approved since 2005 and is a silicone balloon that's inserted under endoscopic guidance. And Typically inflated with 500 to 700 CCs of saline. It's approved for six month use and then removal is performed by basically endoscopically puncturing and

deflating the balloon with a needle and then removing it with an endoscopic grasper.

I think just for people doing this in practice, probably the important thing to note here is that when the balloon is removed, it should be done typically under general anesthesia. So you have a durable airway in place as you pull the balloon across the patient's hypothermics, because it does. take up a fair bit of space coming out of the mouth.

For any trainees and practitioners listening, probably the most important things to be aware of in terms of kind of middle of the night phone calls and seeing Pete consoles in the emergency room are things like nausea and vomiting. Very common in the early post placement period, and often patients require at least some degree of anti emetics to tolerate on the front end.

Certainly things like mild abdominal pain are not uncommon as well. And just like any bariatric procedure, there's always a subset of patients who, who don't ultimately tolerate the after effects, but in the case of balloons, you can actually just deflate and remove them. So that's beneficial. And Dr.

Yujiki, am I forgetting or neglecting anything obvious on those? No, I, I, again, I think the more tools we have in our armamentarium, the

better there are some patients who really like the idea of you know, a completely reversible procedure that doesn't leave any. any scarring or any other you know, potential long term durable changes to the stomach.

And, and the balloon fits that criteria. It's a very low risk device to place and to remove. And so it's, it's nice to have this in your armamentarium. I think there are a lot of patients who are interested in this and I would recommend that people that are coming into the endoscopic bariatric world, that you offer both suturing and the balloon.

The suturing is going to be more weight loss. It's going to be more durable. But there are some patients who are, who are just really going to want the balloon only. And it's nice to be able to offer that to them because obviously there is still benefit that you just went through for patients when they lose weight.

You know, their quality of life improves and their Comorbidities improve. And so there is nothing wrong with balloons. I think they're another great tool. You

know, comment. Also, we talked about training for E. S. G. training for the placement of Obera that intragastric balloon. Our intragastric balloon is required.

You can't actually order the device without having gone through the training. Another F. D. A. Special control. And in that training, you mentioned kind of the perioperative care of patients managing their nausea, understanding their complaints. That a lot has gone over in that because that, that is kind of the difference between success and not success.

Nobody likes to put a balloon in and have it taken out within a couple of days. And then the other is around patient selection. Some of the problems that have been seen with balloons are related to patient selection and really, really being diligent about Ferreting out any indication of gastric dysmotility, for instance, before you place these balloons in anybody.

So another program that relatively easy to pick up complete compared to ESG, but emphasizes patient selection and empirical procedural management.

Dr. Hedberg we'll start with you. Just wanting to touch on you know, the main revisional procedure that we do endoscopically. I think it's worth giving our audience a little bit about the feel for this procedure and how effective it is both in the short and long term.

Yeah, absolutely. And back up a little bit, if the Polish pops making it in the episode, we got to explain that I was just going to say, I mean, you know, real Polish sausage, it's really Sorosa, you're popping through with your teeth when you take a bite, there's that pop to it, it's the same, it's a weird, you know, it's uncanny how similar it is with the overstitch, but that's where the Polish pop comes from.

So after a bypass, there is good data showing that weight regain is related to the size of the gastrointestinal ostomy. So that, that, that study initially gave us interest in how to endoscopically revise these without having to surgically redo the gastrointestinal ostomy. And there's a variety of techniques that have been described, probably the.

The least invasive but more time intensive is just using

APC cautery. So you can just kind of fry the perimeter of your gastrointestinal ostomy and the scarring that happens shrinks it a little bit. So you keep bringing the patient back, you keep doing APC and it will scar down over time. So that is one way that people do it.

To make it a one, one and done approach we tend to do APC about a centimeter around the edge of the anastomosis. And then we do. Purse string suture using the over stitch. So, one of the studies I did when I was in the lab back in 2016 compared different suture patterns for getting this done.

And we did show the purse string was good at kind of distributing the tension around the anastomosis. And it was more durable than just taking a bunch of interrupted bites. The way you make sure you don't narrow the anastomosis too much is to not complete your purse string. So if you, you know, you make note of where you start your suture pattern and you stop and cinch down that suture before you cross where you started, you really should never be able to completely close the anastomosis.

It is a little scary looking when you're done. I mean, we're usually going

for, like, five to nine millimeters of an anastomosis. So you shouldn't be able to fit the scope through. But it does open up a little bit as the, you know, the patient recovers and I've never had to cut out a stitch or seen any issues with that, even though we shrink it down that tight.

This is called endoscopic gastro. Ostomy revision, EGJR or Tor transoral Outlet Revision. There's a lot of different names for it. Some of the papers written as Tor. look at using ESD instead of APC. So they'll inject or do a lift right around the anastomosis and essentially incise the mucosa and then do their purse string rather than using APC first.

I think they did show potentially a little more weight loss that way. It may scar down a little bit better. But just so you know, there's a variety of techniques. to describe this. Patients never get down to their need or weight after the bypass. I've seen patients lose 50 pounds, 25 pounds. That's pretty typical.

It does seem to stay off for at least five years. We reviewed our own series here recently, and we had about 7 percent excess weight loss from where they started their

revision. After five years maintaining, we don't, in our series of these, we didn't see that weight loss significant enough to change comorbidities like we could see with the ESG, but still, we get reasonable weight loss with this and again, very safe, low, low morbidity.

The one other consideration. And as far as I know, there's not great data looking at this, but sometimes when you put the scope down, you're looking at a two centimeter anastomosis and a big pouch. So we will shrink the pouch down as well. If it looks kind of abnormally large, just to help get a little extra restriction and weight loss.

Great, Dr. Hedberg. Dr. Duncan, do you have a comment? Yeah, just a comment around the the data that was reported on Perstrin for the use of TOR and closing down that gastrointestinal anastomosis. Again, that's something we emphasize and teach in the course rather than interrupted sutures. Seems to be more durable and, and, and less likely to disrupt.

because of that distribution of force. The other thing is controlling the size of the opening, and many

advocate for the use of a dilation balloon for the purpose of sizing. So they'll place their purse string suture but prior to cinching, they'll put an eight millimeter maximum suture CRE balloon across the anastomosis and then tighten down against that.

And that actually does two things. One of which wasn't intuitive to me until it was recently explained. But one is it obviously controls, at least at that time, the size of the opening. But the other is that it allows you to pull that purse string snug. So any additional suture material that's in the tissue is actually getting tightened and pulled through.

So you're not kind of cinching. On a loosely constructed purse string, if you will. That's not obvious because of the bunching of the tissue or the way that the suture is moving through the tissue. So it helps with that size and it helps you to get a secure purse string that's not lax and doesn't have any additional suture

material kind of caught up in the tissue.

That's fantastic information. I think, you know, one thing that I'm sure our listeners are wondering, especially people who are not doing into bariatric procedures on a daily or weekly basis, like we are, is, you know, what's the accessibility for patients? You know, who's paying for this? How has that changed over time?

And, you know, Can, you know, either my patients or friends or people in my life have access to that. Dr. Ujiki, talk to us about that kind of evolution and, and where we're at now. Well, you could have probably five episodes dedicated to this. So, you know, I will just summarize that, yeah, accessibility is important.

And in our healthcare system, I think, You know, it is important to prove to the payers that this is a effective, safe, and durable treatment, which we've done we have level one evidence and, and, you know, certainly we couldn't do it without industry support as well,

but, you know, I have seen over the past three years we went from 0 percent coverage for ESG to now about, we're probably now up between 40 and 50% getting these covered by insurance.

You know, you can think about it very simply, but it's not a simple situation or problem. It's very complicated. Obviously the healthier a patient does with a low risk procedure, that's not complicated, that allows a patient to not even need hospital time you know, a stay in the hospital. It seems to be a win for everybody seems to be a win for the patient, seems to be a win for payers.

But you know, it is a complicated problem. We are seeing, like I said, improvement. We're seeing more patients able now to get the procedure. I hope that continues. The good news is, is that I was a bit involved with the application for a CPT code to the AMA this past year in the fall. And fortunately, it

was approved.

And so there will be a CPT code coming out for the procedure. in likely January of 2026. I think that will do a lot to get more coverage and thus more accessibility for patients. Obviously we're going through the process evaluation of that code right now. But I, I do foresee a bright future for this.

It may not, We may not see coverage, blanket coverage for all endobariatric procedures even in the future, but I do think for procedures like endoscopic sleeve and revision hopefully in the future we will see increased coverage and thus better accessibility. I'd be interested in hearing what Dr.

Duncan has to say about that because I, I know that he was watching that process as well. Yeah, more more than watching and we appreciate the help that Dr. Jiki gave to the application for a category one CPT code. You know, we have a world class team. It's called our Hema team, the health

economics and market access team.

Their job is to break down barriers on access to care for patients and for providers. And and one of the, the hearts of the things that they do in that regard is, coding, coverage, and payment. That's what they talk about. Coding, coverage, and payment. If a physician wants to get paid to do a procedure, if a patient wants their insurance company to cover their procedure, you need a code.

It all starts with that. You need the insurance companies to have a policy that says they cover that code. And then you need the insurance companies to set a reimbursement rate that makes sense. And so that team works on that. The first step for ESG was a code. So that application was put into the AMA, which controls the assignment of codes.

And, and ESG was granted a category one code. So that's, that's great. And by the way, the merit

study was mentioned at the top of this podcast, a prospective trial, multi center trial. It was that kind of data that supported the CPT code. The valuation for that code is ongoing. We should hear this summer about how many RVU units will be assigned to that.

From CMS. And then we will continue to fight battles around the coverage and reimbursement. And we're doing that already. One of the things that's really important for that effort that the audience should know is society guidelines. Insurers really look at society guidelines as why should they cover this procedure?

And it's been pretty exciting in the endo bariatric space the last 20, the last 12 months. Has seen a lot of activities. It started with the National Institute for Health and Care Excellence, NICE. which is a UK body but they they provide guidance to what's going to be covered within the

National Health Service.

And they approved ESG. And while to an American audience, NICE might not seem very important, because they do such rigorous review, the NICE guidance is used around the world by many payers. And in fact, the state of Washington now covers ESG for their employees in their covered lives. based on the NICE guidance.

ASGE, the American Society of Gastrointestinal Endoscopy, along with ESGE, which is their European counterpart, they published a guidance a guideline that includes the use of ESG for patients suffering from obesity. And then just right before the holidays in November of last year, if so, the, the International Federation for Surgery of Obesity which is a, which is a federation of 77 bariatric surgical societies around the world that includes ASMBS in North America they published their

guidance on the use of ESG, which also endorses it.

And in fact, if anybody in the audience wants kind of the cliff notes on all the data that's out there for ESG. The if so document is excellent because they did a meta analysis of all of the data and then use that to support it. So, that's, that's a bit of a long story. The short of it is that many patients are still paying cash for this procedure.

Our job as a company, and our job as healthcare professionals and societies is to change that metric. And I'm excited about moving forward. That CPT code will kick in in January of 2026. And then we hope to continue to break down barriers for coverage moving forward. Well, thank you, Dr. Ujiki and Dr.

Duncan. That was incredibly informative and taught me a lot. Hopefully we can continue to get more accessible coverage for folks as we go forward. But Dr. Crafts, let's take it to you to wrap us up with our quick hits. Absolutely. So quick hits for

today's podcast. Number one at the top ESG and intragastric balloons are primary bariatric procedures available for patients who are seeking endoscopic options for weight loss.

Number two, ESG is the gold standard for primary endobariatric procedures and has demonstrated excess weight loss upwards of 50 percent more effective than lifestyle modifications alone. Number three, at least a basic foundation and endoscopy is important to being able to successfully perform endobariatric procedures, particularly ESG.

And number four, the use of endoscopic suturing and APC can be used to perform endoscopic GJ revisions that have shown promising outcomes for short term weight loss without the need for surgical revision. Thank you guys so much for tuning into our second episode in the Surgical Endoscopy Series. This particular episode is going to be accompanied by a couple of instructional videos.

One for Endoscopic Sleeve Gastroplasty and the second one for Endoscopic Gastrojejunal Revision. So make sure to check those out on the Behind the Knife website. But for now, this is the Behind the Knife Surgical Team from

Endeavor Health along with Dr. Brian Duncan reminding you to dominate the day.

Thank you all.