So, next, we are going to Hyderabad, India, my home Institute. I'm pleasured to introduce Dr. Nagi Reddy, who will demonstrate an anti-reflex mucosal ablation procedure. Dr. Reddy, you are live on. Can you hear us? Hi. I'd like to thank ASG for giving us the opportunity. So, we're going to demonstrate another anti-reflex procedure. Amit just showed you GERDEX. This is, of course, what we've been doing for long, but another procedure which probably is more endoscopy friendly. I'm here with colleagues of mine, Dr. Rakesh, who published a paper on GERDEX in the gut. Dr. Santosh is an anesthetist and Dr. Harnath. So, we're all here for this procedure. This is a young patient who had similar features to what Amit has showed you. A female patient with 3S reflex and upper GI endoscopy showed HILT grade 2. Manometry showed normal esophageal motility and a 24-hour pH impedance. So, exposure time of more than 6.5 with 75 reflexes and DEMIS score of 43. The plan is to do an anti-reflex mucosal ablation, so-called AMA, because learning objectives are how to select these patients. We'll discuss this as we go along. In fact, we have a lot of time. This is a very short procedure, so we put in some of these slides, although initially they didn't want us to. The second thing, of course, is to look at the actual technique that we're going to describe. And finally, if I can have the endoscopy picture, we'll go to what we see in these patients at the G-junction. This is probably a HILT grade 2 that we are seeing. The HILT classification is given there. Again, this is for people to become familiar with. HILT grade 1, 2, and 3, this would be probably grade 1 to 2 in between. Yeah, so you can see that very clearly, so that we can discuss later if you want. Now, what this procedure does is that we're going to create a burn, mucosal ablation, mainly on the lesser curve, leaving a small bit of about one centimeter of the gated curve intact so that complete stenosis does not occur. This is a procedure that Inouye started. He started with arms first and then switched on to armor now. And again, this is what we have been doing. I think the case selection we can discuss between armor versus GERDEX, what you would do. Basically, in this procedure, what we would do is, I think we'll get back to our results later, but if we can show the endoscopy picture. If you can see the endoscopy picture, you can see here that I've retroverted my scope. I'm using an Olympus EZ 1500 scope. I'm looking at the G-junction carefully, and if you can see, this is probably HILT 2 now here. HILT 1 and 2 are the people who benefit by this procedure. HILT 3 is not good for this, and of course HILT 4 is probably surgical. What's the plan? Yeah, Moin, the plan is first, I'm sure you can see very clearly the greater curve, the lesser curve. This procedure has to be done in a horseshoe fashion on the lesser curve, leaving about one centimeter of the greater curve part intact. So what I'm going to do is, I'm going to use a Herbie APC catheter to mark out that area which I'm not going to, that is, I'm going to leave it alone. I'm using an Herbie machine VO3. The power settings are very important for this. The power settings, if you can concentrate on the machine, I'm using a power of 9.3 effects, 99 watts, and also the flow is going to be 0.8 liters per minute. This is the thing. This is a little different from what we do a standard procedure. Now, the very important thing is to create this beyond the skimmer columnar junction, because if you include the skimmer columnar junction, you'll get into problem, because it'll produce stenosis. So what I'm going to first do now is, I'm going to mark out the area which I'm not going to ablate. So I'm using an Herbie APC catheter, APC catheter to first mark out this area. After I do that, I'm going to raise the submucosa and then do the actual, this is the first APC mode that we're using. You will end up using that same catheter for ablation later. So yeah, so ideally you'd have a hybrid catheter. You can use Pratik, but what I'm going to do is, I'm going to use the injection technique, because that's accessible to most people. Okay. And then use this only for ablating. So this is the area I'm going to leave intact, right? And now I'm going to go to the other side and then leave a small area here. So I'm going to leave... Why is it so important to keep this area intact? I didn't get the question. Why, why is it so important to keep this area intact on the greater curvature? Yeah, because if you include this area, then the stenosis is a very high chance, and these people can sometimes go into dysphagia because of the stenosis. So you have to leave at least one centimeter of the mucosa on the greater curve intact so that the complete stenosis does not occur. That's the reason. Hey, Mackie, did I hear you correctly? So the two methods you can use, inject and then use the standard APC versus you can use the hybrid APC, right? Exactly, exactly. So we can use two methods. And what I'm going to now use is of course the injection technique with a needle. This is something that anybody can do because you don't have to have a hybrid generator for this. I'm now going to this area below the squamous columnar junction. You could see it very easily earlier. And then I'm going to inject here. So this is a standard injection needle that we use for all the standard submucosal injections. Needle out. And what I'm going to do is I'm going to... So Nagi, you're again using saline with a few drops of a blue dye? Indigo carmine, yeah. Nagi, while you're doing this, tell us about the arms thing, right? I mean, so the reception part did not help that much. Yeah, the same thing can be done. Same thing can be done in terms of resection. The problem with resection is sometimes the bleeds are a problem. So therefore, it's a little more technically difficult procedure. You see, I created a nice bulge there submucosally and now I'm going to do the APC. When you do the APC, what you have to do is one centimeter on the lateral sides and on the lesser curve side, I do two centimeters. So it's not exactly circumferential. It's a horseshoe with a tail coming onto the lesser curve side. Yeah, we know from submucosal endoscopy, Nagi, that this is the most vascular part of the stomach. Exactly, yeah. So Mohit, you're absolutely right and that's the reason why we, of course, we used to do a lot of arms earlier. They used to bleed, but of course, you can control these beads very often. But what we find is that with this, the chance of that is not there. So it's very technically very easy. So the technique is I'm holding my scope in the right hand with the probe outside so I don't manipulate the probe and as I can sort of spray, this is the first population, so I get a spray here. I have to keep away from the junction. It's about one centimeter this side. See this? It's about one centimeter here and then when I go to the lesser curve side, it's going to be longer here, tail here. So it's a very easy procedure and chance of complications. Again, you're following the same principles of APC here in which you're trying to form that arc and get the mucosal ablation on that. Now as you're doing this, what's the endpoint you're looking for on the mucosal side? Is there anything specific in terms of either a color or the charring? I mean, how do you define that you have enough ablation? So this is very subjective. We don't have any objective way to define it, but usually when you get a whitish color, that's optimum. If it's brownish, it's a little more deeper you have gone into, but doesn't matter. But one would want it to be a little more whitish there, so you get a whitish appearance here. Now for this patient, what would make your choice between ARMA, GERDEX, TIFF? What are the factors you consider? This is a very good question. If this patient had a volume reflex, I would think more in favor of GERDEX. But if there's no volume reflex, the indications are similar, but volume reflex makes the difference. If there's a volume reflex, then I tend to do GERDEX in these patients. Now we don't have TIFF in our country, but TIFF is if there's a hiatus also, you can do TIFF, whereas with this, you can't. If there's a hiatus, you can't do it. More than three centimeters hiatus, you can't do this procedure. If somebody developed post myotomy GERDEX, is that still a contraindication to ARMA? I know it's a contraindication to ARMS because of the high stricture rate, but is it still a contraindication to ARMA? No, no, no, no. I think that is a good indication in fact. Yeah, GERDEX we have done. I think GERDEX is more ideal in these cases, but ARMA is also very useful for patients who had bariatric surgery and subsequent to bariatric surgery, they develop a problem. Then I think this would be an ideal solution because you don't have enough space to GERDEX. What about post-POEM? Post-POEM GERDEX I think is better because the problem with POEM is that the mucosal area becomes very thin after that. The chance of perforation is very high. You don't want to have that. I believe that for post-POEM GERDEX is better. You see some smoke there. I'm trying to aspirate the smoke out. What you can see very carefully is that my ablation is much longer on the lesser curve side than on the sides. This gives it the longitudinal scarring that creates the valve here on the opposite side. Again, nice demonstration. Nagy also for the young fellows and the trainees who are looking at this is how he's controlling with the help of the scope rather than moving the probe back and forth. That's something which fellows do quite frequently is try to move the device than the endoscope. This is the end of the procedure. You can see that on the lesser curve I have a much bigger ablation compared to on the sides here. This ideally gives it the typical scarring. If you look at this patient after three weeks, I think what will happen is you'll have a nice scar there closing the G junction. Sometimes smoke comes in like this so the vision comes a little opaque but then we sort of suck out all the smoke and then we're going just to show you this. Nagy, there's a question. Post-sleeve, how do you manage these patients? How do you retroflex? Post-sleeve? Yeah. Post-sleeve gastrectomy when they have a reflex moin, we prefer to do this procedure because it's quite easy. Retroversing the scope is not not very difficult whereas retroverting the device is more difficult. So, that's the reason why we tend to use this. I just want you to see the tongue again. See the tongue here that comes on the lesser curve. This is very important. You have to produce a tongue on the lesser curve. So, this is the actual procedure. It's very simple. It's unfortunately over too quick. So, Nagy, just just tell us about the post-procedure instructions to the patient. Any chest pain or you know that they get after this and are they NPO for a while? It's an outpatient procedure. Can you walk us through that? Yeah. Yeah. Good question, sir. I think there it's an outpatient procedure. We put them nil oral for six hours. Watch for any abdominal pain and like Moin commented earlier, this is a vascular area. So, you want to be careful that they don't have any minor bleeds from this area. So, after six hours observation, they're sent home. Very rare reports of perforation especially if you don't inject the submiposa, you can get a perforation. We have had, we haven't had that problem. We in fact, this has been a fairly safe procedure that way. So, outpatient, six hours observation, watch for any bleed, watch for perforation. After six hours, patient is allowed liquids and after 12 hours, allowed solids. We'll just show you a small interim analysis of a recent study that we published. This is at six months and extended now to 12 months also. You will see both in terms of health-related quality of life, heartburn, regurgitation score and so on. It's fairly impressive and now Inovi has done a study comparing arms with armor. This has been published recently where they showed a similar effect. So, what Inovi's group has done and what we are doing also, getting away from arms because arms, I think for people like Moin who do a lot of ESDs, it's okay but for a general gastroenterologist, it's not so easy to do but the armor is much easier. I mean, anybody doing upper GI using an APC probe, as you can see, have been demonstrated very easily. They can do it and therefore, I think this procedure has a huge potential among practicing gastroenterologists. So, Nagy, if somebody has the IRB 300, not the 3.0, what settings do you recommend? Yeah, for the same there, what we would do, we have been using only 300 in our department. What Inovi recommends with the previous machine was again 100 watts, 1 liter. There's no effect there. 100 watts, 1 liter flow whereas with VO3, it's 9.3 effect and it's a forced APC. It's very important. You have to use a forced APC. There are two other modes, precise APD and you have a pulse APC. So, what we use a pulse APC. Reyna, you had a question? Oh, sure. That first slide you showed, the symptom scores decreased from three months to six months. So, are you seeing patients are doing better even longer out? Yes. So, we followed our patients for 12 months and as the fibrosis increases, they do a little better. In fact, the results get a little better later on. We don't have a long-term follow-up. We don't have like two years, three years set but up to 12 months, there seems to be a progressive increase or decrease in the symptoms. The health-related effects seem to increase by about 12 months. Nagi, what's your follow-up in terms of this patient? Once he goes home, you know, repeat either PH study, repeat endoscopy, you know, how are you going to follow up on that? So, Pradeep, there are two different sets of patients. Those who come in a normal practice, we don't do anything except follow them up with their symptoms and so on and probably get a scope done only after a year but we are most of them are on a protocol. So, they get a PH study at three months and then six months and 12 months. This is because of the study that we're doing. Otherwise, clinically, they don't require to get anything done. We just follow them on symptomatic basis. About 70% of them, we are able to take off PPIs. Another maybe 10% decrease the dose of PPIs and this maintains up to 12 months also but I think the most important point was a question that somebody asked earlier regarding GERDEX versus AMA. We have extensive experience with both. With GERDEX, we generally select patients whose HILS grade is two or sometimes three. Volume reflex. Volume reflex is a very important discriminating factor between what you should select from and of course, esophageal peristalsis is a must in both the cases. So, I think it's very important to work up your patients properly before you do these procedures. In terms of hernias, if somebody, can you tell us if somebody has a small hernia that's okay to do this procedure? Large hernias, it becomes ineffective? Yeah, Mohin, if it's more than three centimeters in size, we don't do any endoscopic procedures. If it is a small hernia, less than three centimeters still, then in these cases, we prefer GERDEX. It's only when this HILS one or absolutely, when there's no hernia, then this would be, AMA would be a good procedure. If you have a small hernia, there are, I mean, even Inoy has demonstrated doing AMA and shown that it closes up but in our experience, it's better to go for a GERDEX for small hernias rather than AMA. There's a question in the chat, is it possible to do AMA again in a patient that had AMA done previously? Yeah, so that's a good question and we have done it too. When initial phase, when AMA technique was coming in, it was not standardized. For example, we're not leaving this long tail. Some of the patients would come back with recurrent symptoms. We would assess them again like we're assessing a new patient and then if they have significant symptoms and reflex correlate on investigation, then these patients, we have done a second AMA but this would be a very small percentage and now when we standardize the procedure, the need seems to decrease but what happens is probably after two or three years, maybe we can repeat this procedure. So, it'll be something like patient coming in after two, three years getting another AMA and then coming back again. As long as it's off PPS, they're happy. What happens to this mucosa, submucosa area in this area? Probably a lot of fibrosis occurs but fortunately, there's no dangers in repeating the AMA. So, one of the things just Reina also about this is that you know unlike the full thickness placation devices, some sham control trials are missing in this area and I think that's what we probably need and will be doing in the next few months. So, Rakesh who's on the right-hand side of Nagi, if you want to wave Rakesh. So, you know, Rakesh and our team, we are planning on doing a sham control trial and Rakesh, was it a 12-month follow-up or something that we are planning? Right on that. 12-month follow-up, yeah. Yeah, so I think in that, we will get whether in a sham control trial, how does this perform? So, this is a little bit behind the other devices but as Nagi nicely demonstrated, it's quite easy, safe to do and with very minimal requirement for additional sort of equipment. Yeah. Prateek, you're absolutely right. I think the beauty of this procedure is it's very simple, very easy to do and I think this is something that all gastroenterologists can do. GERDEX like as Amit demonstrated nicely also is an easy procedure but still involves putting in a fairly big instrument in and still some amount of learning curve is there. For this, for Ama, I would think the learning curve is about five cases. Okay, great demonstration there, Nagi. We'll see you back at the question and answer session. So again, AIG team, congratulations and great job as always to do that. Venkat, over to you. Thank you.

anti-reflux mucosal ablation

AMA

GERD-X alternative

endoscopy-friendly procedure

Olympus EZ 1500 scope

Herbie APC catheter