and welcome, Amit. So what I'm also going to do is have our panelists, including our two speakers that you heard. So Felice and Ken, thank you very much. Please join us. And the two other folks that haven't spoken, but will be part of the panel discussion and the case discussion. The first one is Reg Bell. Reg, welcome. And we are really looking forward to your interaction with the endoscopist and the gastroenterologist. And last but not least, Peter Kourilas from Northwestern University. So again, welcome to the entire panel and to our speakers, Felice and Ken. Again, wonderful talks. And this really leads into well with Amit's case presentation. So Amit, over to you. Yeah. So thank you so much to Pratik as well as Vani for inviting me for this really wonderful course on virtual esophagology. And I'm very honored to be part of it with all the learned panelists and all our speakers. So we heard very two very good lectures from our two speakers earlier. And what I'm going to present to you is just one case which we see very, very commonly in our day-to-day clinical practice. So let me begin with that. These are my affiliations. I do not have any disclosures. As you can see here, we have a young male, 48-year-old male who is a high-profile executive and a very hectic lifestyle. And he has been symptomatic for five years. And the main symptoms which this gentleman has are frequent episodes of heartburn, chest pain, as well as intermittent cough. And in spite of having double-dose PPI, he has shown a partial response to PPIs. Not only that, but as soon as he stops the PPI, there's immediate recurrence of symptoms on stoppage of the PPIs. So we investigate him. And if you see here on this questionnaire, the GERDQ score was 10 after asking him these questions related to his symptoms of the GERD. And on conducting some investigations, as shown to you by Phyllis in our lecture before, you see here that on a 24-hour impedance pH, this gentleman had 120 acid reflux episodes. And if you see here, the abnormal acid exposure time was 12%. So both of these are grossly abnormal. And there was a very strong symptom relationship, very positive. You see here, these are the two graphs. And what is important to note is that out of these 120 acid reflux episodes, the longest acid reflux time was eight minutes. And overall, if you see a combination of volume as well as acid reflux, the longest reflux time was 1.5 hours. So everything was fitting in favor of a symptomatic GERD in this young individual. And we performed a high-resolution manometry just to make sure that the esophageal motility is normal so that we can plan the treatment strategy properly. And you see here on the HRM, we can see a typical type II EGJ. There's a little bit dissociation between the pressure zones, between the EGJ and the diaphragmatic crura, as you can see from this chart here. And what did we find on endoscopy? On endoscopy, I just want to show you only one image, which is in the retroverted position. And as we saw from the slides presented by Ken, this person had a very classical Hills Grade II gastroesophageal flap valve. There was no erosive esophagitis, no evidence of any barrets. And this is exactly what we found on the retroverted view on endoscopy. So you see here that the OG junction is lax. It is not gripping the endoscope. And if you see this angle of his, it's become quite obtuse. It's no more acute. So there's obliteration of the angle of his or the GE flap valve. So now this is the situation. Now, this is a very, very common condition, which we see in day-to-day clinical practice. There is no gross hiatus hernia. There's not too much dissociation or different between the distance between the diaphragmatic crura, as well as the OG junction between the LES. And this is what we find on the endoscopic picture. So the questions to the panel here regarding this very common condition, which we see in clinical practices, how should we treat? Do we just continue PPIs on a regular basis? Or we tell the patient to take PPIs on demand? Or third, we ask them to go ahead with some simpler procedure like ARMS or ARMA, which has been described recently, antireflux mucosectomy or antireflux mucosal ablation, which can be done by any gastroenterologist in their practice. They don't require any specific device, just a simple diathermy and maybe an EMR cap. Or whether we should subject them to either a TIF procedure or endoscopic full thickness placation procedure by using all those placated devices endoscopically. Or do we subject this patient to a laparoscopic fundoplacation and take a surgical opinion? So I throw these questions now open to the panel. So I think first I will ask our medical gastroenterologist in the panel. And Pratik, you can take it ahead. Should we continue PPIs on a regular basis or just continue PPIs on demand? Or should we subject them to some interventional procedure? Sure. So what should we do? So Amit, thank you. Excellent case. And you're absolutely right. We do face this quite frequently. So let me start with Peter. Peter, any suggestions on the PPI aspect? The PPI aspect. I mean, it seems that he had some response to it, although he may be a little bit non-compliant with this. So what's your suggestion or thoughts on PPIs in this situation? Well, it's actually a fairly clear cut case in that there's nothing contradictory here. So every test done confirmed that there was reflux. There's response to a PPI, albeit imperfect. There's recurrence with this continuation of the PPI. So this actually represents a fairly straightforward case, not necessarily easy, but straightforward. And the gentleman clearly needs some augmentation of his current antireflux therapy, unless he's happy with this. The one thing not mentioned in the case presentation was what his BMI was, because that might figure into the conversation. Oh, the BMI was not too much. The BMI was just 30. So he's not a very obese individual. He's not a very obese individual. But in Indian standards, yeah, in Indian standards, that can be considered as moderate obesity, because in India, in Asians from 28, 27 onwards, we consider them as obesity because of central obesity. It's not a major consideration. Not a big one. I nonetheless would advise him to lose weight as an intervention that might be beneficial here. Weight loss is helpful, not only for typical reflux symptoms, but for cough as well. Okay. I always say that. I know that it's not generally gonna happen, but I think it's always important to say that. As far as whether or not I would do continued PPIs, absolutely. It would be BID as adherent as possible. And that would offer an anti-reflux procedure. In my practice, that would not be an ARMS or an ARMA procedure, because we simply don't do them in Chicago, but it would be either a TIF procedure, a LYNX procedure, or a conventional laparoscopic fundoplication. So Peter, just as a follow-up to that is that, would you continue the BID-PPI therapy and for how long to see the response before you look at other alternatives? Or are you discussing all these alternatives right now with the patient? No, I'd be discussing them right now, but I certainly wouldn't be continuing it because ultimately it's a lifestyle choice as to whether or not he's going to be satisfied with the treatment benefit of the BID-PPI. Some people it's going to be good enough, some people it's not. Okay, thanks. So my question here, Pratik, I'll just interview you in a minute. My question is that, if the patient is reasonably satisfied with the result of BID-PPI, only in between he gets episodes where in spite of PPI, he gets a reflux. How long do you think we can continue these PPIs? Can you continue for years together? Is it safe? Yeah, I think it's absolutely safe. I mean, I have no reservations, whatever, to chronic years worth of PPI therapy. Okay, any other... Felice, any suggestions on, or what sort of PPI side effects do you discuss with the patients, specifically if we are contemplating long-term therapy, such as in this individual? You know, I'm going to answer the PPI part, but I'm going to just make one comment. The first is, you know, this is sort of like the dream patient, right? So we're saying this is, you know, common, but let's be honest, very often they don't all stack up in this way. And I would say, in terms of making a decision as to what to do, my first question is really back to the patient. What is this individual person's preference? You know, I will discuss all the options with them, right? You know, in terms of medical management, because I do believe medical management with the PPI long-term is safe, but I will also upfront in this individual, I will start talking about anti-reflux procedures as well upfront because they seem to be sort of a perfect candidate, right? You know, when you look at this individual, this person does not sound like a functional patient. This sounds like someone who truly has GERD. And so doing a anti-reflux procedure with any potential side effects even related to that, you feel like you're sending the right patient to a procedure. You feel comfortable with what you're doing in that individual. So I will definitely bring it up with that patient as well. And, you know, because it wasn't even a hiatal hernia, it's not even all the endoscopic procedures are really at play in this individual as well. As- What happens is, sorry, before you go on to the PPI side effects. So what happens commonly is the patient will ask you, doc, what do you think? Should I continue PPI therapy or should I undergo a procedure? So what's your response then? So the way that I answer that question, sometimes it's actually even looking at the patient themselves in terms of their age, how long they need to be on this, how much is this really impacting their lifestyle? Because we didn't really go through that part, right? And we're talking about, does it improve their symptoms? But then there's this other whole piece, meaning having to continue to take the medications. So that's more how I explore it. You know, there are individuals that just don't wanna be on these medicines. The medicines work, they have a diagnosis of GERD, but they don't wanna stay on them, not because of side effects, just because they don't wanna take a medicine two times a day. It's hard to remember to take a medicine two times a day and they might want a more definitive treatment that could take medicine out of the picture. And I think that's sort of, it's more really, it's individualized, it's personalized. It's not cookbook in this. Like, what would you do? It's really, I keep on going back to that patient because in the end, we can all feel comfortable afterwards. And the reality is, surgery can still be offered, you know, in a year, in two years. We don't take it off of the plate, right? They could say, I wanna see how I do for the next year. I'm comfortable on PPIs. And then I say to them, look, you know what? Come back and we can again discuss this. So I think that's kind of how I approach that question. Excellent. So Felice, going back, what are some of the side effects that you discuss with your patients about long-term PPI use? Okay, so as you can imagine, this is the bane of the existence, the gastroenterologist, right? So the conversation, and I wish I could get a lot of, you know, our views on conversation related to this, but this is really helping the patient getting to the point where they feel comfortable. My feeling is that, and I know that others on the panel would obviously say this as well, the studies, as you continue to go forward with these studies, prove safety of these medications. Of the ones that I will watch a patient are patients who have known renal issues, known renal insufficiency that is going to be potentially a group. And certainly it's a group that's playing more in the kind of litiginous world of things. And so that might be a patient population that I would be more, you know, reticent or speak to in terms of following if they have renal insufficiency. And then patients who've had C. difficile, a conversation on potentially related to that. In terms of the others, you know, I feel extraordinarily comfortable with these medications. Great. Reg, let's get you on there. I mean, they're just handing this over to you in a lap pretty much saying that, hey, you know, it's probably time. So is this somebody you feel that would benefit from a laparoscopic fundoplication? Any other investigations you need before that? Or is this somebody that you want to send to Ken or Felice and say, hey, let's do that TIF that Ken's been talking about for a while. So what's your approach, Reg? Well, I think ultimately it's a quality of life issue. And Amit, I didn't look over the RDQ when you showed it in detail, but if I recall, there are three questions, heartburn, regurg and indigestion kind of. If regurg is a significant symptom, then anti-reflex surgery is going to be the best way to treat that. If it's indigestion, I'm going to be a little bit more hesitant about that. So I really look at that, those three questions in a little more detail. Also, I look at the pH test. I assume this was done on PPIs showing significant acid exposure, if I recall on that pH test. So that's going to argue to me that changing PPIs may not be as effective and may not control symptoms as well, especially if that symptom is heartburn and or regurgitation. I actually assumed it was done off PPIs. PPI was stopped, PPI was stopped. Thanks, Peter. So we'll disregard that. Anyway, I think this patient is an appropriate candidate for surgery, but I always look at the side effects of surgery compared to their quality of life currently. And if the quality of life currently is not too bad, PRN sort of a couple of times a week, they get some breakthrough heartburn, then a Nissen is not for them. I would not recommend a Nissen for this patient. Can I ask one question, Reg? One question to you, that do you base your decision of surgery on the grading of the hills, whether it is grade one, grade two, grade three or grade four? Maybe grade one and two are more, or grade two, one and two are more suitable for an endoscopic approach, and three and four are better off with surgery? Or only the symptoms? If we took insurance questions out of the issue, yes. But I think, so basically, I think we have a spectrum of efficacy versus side effects. So a pure TIF has the fewest side effects, fewest risk, maybe strata off there on the side. To a Nissen, which to me is something I reserve for someone with LAC or D esophagitis on PPIs, long segment Barrett's. So to me, there's a spectrum of procedures we can offer patients, and I grade that based upon the severity of the disease and their symptom severity. So a patient like him, I think a TIF, or actually, I think he needs a hiatal hernia repair and a TIF based on the dimension. The transverse dimension of the hiatus is very, very important. And I think that's about two and a half centimeters. You can use the scope as about a centimeter. That's two and a half centimeters. That's more than a TIF is good for, a pure TIF. It needs a chiroplasty. And to be honest, I'd been kind of hesitant about this combined TIF with chiroplasty until Ken Chang's data came out this year. And it looks very, very good, extremely good. And so I think I'm going to put that into that armamentarium of things. So in the spectrum, I would think about a combined TIF. I would think about a LYNX before I would think about an anterior fundo or a NISN. And I would tell this patient, you don't want a NISN. You don't want a NISN. So Ken, let's go to you about, it seems endoscopic therapy appears to be a good option in this patient here, despite having long-term follow-up data like the fundoplication, right? I mean, we're talking about a 10-year, 15-year follow-up that we have with laparoscopic antireflux surgery, whereas a couple of years of follow-up with a TIF or any other endoscopic procedures. So what's your option here? I mean, do you think these procedures are long lasting or does the patient need to come back again in three, five years and get a second TIF? Or what's the rationale here of an endoscopic procedure? Great question, Pratik. So in this patient, assuming they're truly refractory and the indication is beyond PPI. So we're looking at either procedural, surgical options. I look at what will give the patient the immediate symptom relief. And what about the long-term relief? As you're alluding to, he's only in his forties. So that's young. Since I'm in my sixties, that's really young. And so in the long run, the endoscopic approaches won't last very long, whether it's arm, whether it's maze, whether it's wrap. In the short run, yes, they'll get symptomatic relief a year, two years. But then with that open hiatus, that G-junction will be sliding up and down all day long. And the beautiful valve you create endoscopically will deteriorate in a short, relatively short period of time. So like Rich says, with that hill grade, it's a two to three now, a 2.5 diameter that for a durable fix for long-term, it needs a core repair. And then what you do for the flat valve can vary as we talked about. One interesting piece is because he's young and let's say in 10 years, studies have shown that there's a reasonably high recurrence rate because things loosen. And if it's just the flat valve that's loosened, then you can do an endoscopic repair such as TIF alone at that point. But if it's the cura that fails, it's also easier to redo if you don't have to take down the wrap. So if you, all you have to do is go back and re-repair the cura and you can do the fundoplication endoscopically, that is a theoretic benefit in a younger patient like this. So if there's a sense of urgency, the patient doesn't want to go to surgery or the anatomy doesn't permit, let's say the patient had a prior sleeve gastrectomy and there's no fundus to work with, or they've had a esophagectomy and this is a pull-up procedure, then your endoscopic gastro gastric placations are your only options. And you settle for that because that's your only option. But if we were looking at short-term and long-term for this gentleman, I would say a hernia repair plus some sort of fundoplication, either laparoscopic or endoscopic. Okay, great. Reg, let's go to you as you have some long-term data available on some of these procedures. Well, so, um, way back in about 2009, I did, we did about 150 pure tips and, uh, re-operated on about 25% of them ended up converting them to fundoplications, probably because we didn't understand the size of the hernia and that sort of thing. And I kind of, yeah, and I, and I stopped doing tests largely because of that. I went back a few years ago and said, let's look at our long-term outcomes with patients. And so it's in press, but at eight years follow-up, about 80% of patients who had had a pure tip were doing well, if they were not in that 25% that we had re-operated on. So it looked to be far more durable than I had ever imagined. So Reggie, you're saying 80% of 100% or 80% of 80%? 80% of 80%. Okay. So, uh, yeah, that's the per-protocol analysis, Peter. Um, so let's, uh, uh, Amit, you know, you've been, uh, you know, doing, we've heard from Ken and Reg about TIF and Esophagus. How about the GERDEX, which is also a fundoplication, uh, procedure endoscopically. Can you make some comments on that and your experience with it? Yeah. See, for example, in India, we do two procedures, which are very common for such type of a situation. One is the arms. And we find that it is a very, very nice procedure if it is done, uh, in, you know, the right way, because it's a very natural procedure. You don't apply a staple. So there's no device involved and it causes a natural augmentation of the sling and it enhances the angle of his, as well as, um, makes the, uh, gastroesophageal flap valve acute. So I can just show you a video on that. But the second is the GERDEX. GERDEX is just a endoscopic full thickness placation device, little bit different from TIF. It is actually like a staple and that can be applied on the lesser curvature. Initially, we started applying on the greater curvature. I can show you a quick video of that. That's still not available in the United States is commonly used in Europe and in some parts of Asia. Uh, but that device is not yet available in the U S but that is another excellent technique for GE flap valve one and two type of cases, because, uh, all of us know, and even Reg said that there are some issues associated with fundoplication like post fundoplication gas bloats and difficulties, which the patient is likely to face. And, and even fundoplications, I'm sure Reg will agree with me. They are not completely durable. If you see long-term studies of fundoplication, we do see that in spite of doing a surgical repair and a fundoplication, even these loosen up, uh, over a period of years, over four or five years later. So it's not that any procedure which you do, because this is the dynamic area, which is constantly moving. So any type of suturing or stapling you do is bound to loosen up in the years to come because it's constantly moving with every breath because of a diaphragmatic contraction and relaxation. So I can just show you a couple of videos in case you want to see that. Yeah. So Amit, while you're putting those up, let me just, we have six minutes. So there are a bunch of questions. So let me quickly go through them. So Felice, for you, how do you distinguish a Schatzky's ring from a peptic stricture on endoscopy? So that's a question from the audience. So brief answers, uh, panelists. So Schatzky's ring should be at the level of a Z line. It's going to be symmetric. And in terms of being able to differentiate that as a peptic stricture, there should be no erosive esophagitis. There should be no, uh, Barrett's like mucosa. And you're also going to talk to the patient about their symptoms, but you know, perfectly symmetric at the Z line. Um, and then, uh, in terms of looking at an esophagram, it can sometimes be challenging for the radiologists, uh, to be able to tell the difference. That's why you take these other parameters, uh, into play as well. Okay. Excellent. Thank you for that. Uh, uh, one question, uh, Peter, which I, you were answering there is for GERD testing and Felice showed it. When do you do the pH testing on versus off PPI? Well, your, your standard is always going to be off PPI. It's a very select circumstances that you're ever going to do it on PPI. It gets down to, um, does this person actually not respond to acid inhibition or are these somewhat atypical symptoms actually related to reflux in the setting of PPI therapy, but it's always a second test. Okay. Excellent. Uh, Reg, what type of patients who are offered these procedures, whether it's endoscopic or surgery, besides the diagnostic toolbox that Felice showed, any other sort of pre-surgical pre-procedure, uh, diagnostic testing that you would like that you definitely want before the procedure? We pretty routinely get a city esophagram in any patient that has, I call it borderline motility, uh, because I do think it helps us, uh, assess the best procedure for patients. Um, and a city esophagram just gives me a visual representation of how the esophagus is pushing. Uh, so that's, it's not necessary, but that's optional. Sometimes in patients that have a lot of reflux and a pretty normal anatomy, I'll get a gastric emptying study. Okay. Perfect. Thank you. Uh, Amit to you, you want to show us some videos or something? I'll just show you this now. This is a video of antireflux mucosal resection. So this is how we use a EMR cap. So this is like a, a cap suction and snaring technique. So we have to inject the sub-mucosal space with some solution, like a normal saline mixed with some indigo carmine or methylene blue. And, and we just keep on resecting the mucosa on the lesser curvature. So two-thirds of the mucosa on the lesser curvature, uh, we have to resect it until we get a picture, something like this over here and this much area, uh, almost, uh, the, the, uh, if you see the distance, the diameter, just more than the size of the scope, we leave it intact. So this much mucosa, we do not resect. I just want to show you what we see one month later, because this is what we see after the resection and this heals by secondary intention. And because it heals by secondary intention, this is exactly what we see. Uh, once we come over here, you can see this, this is scarring on the lesser curvature. So it acts like a sling. You can see how the greater curvature sling fibers, they are getting pulled up. Now this remains quite a long time. This is quite a durable procedure, very simple procedure to be performed by any gastroenterologist in their day-to-day practice, because all you need to learn is the technique of EMR. And this is what I was saying by arms. Same thing can be achieved by simple mucosal ablation. All this area can be ablated by a spray coagulation current, which is quite deep. And this itself can cause sufficient amount of scarring. You see, this was our paper, which we published recently at, um, you see here in the digestive endoscopy. This is just a, just a single center study. I don't, I think you, this is not the something which you can follow because this is not a multi-center study. It's not a randomized study comparing any, uh, any, uh, base, but you see a 62 patients of refractory GERD and reasonably good response. Um, you know, one year follow-up 61% of patients continued with significant symptom improvement and quite a large percentage of patients stopped their PPIs, almost 70% of patients, they stopped their PPIs after this arms procedure. And what I meant was the endoscopic full thickness placation is this, uh, device that this is also a little bit similar to how it looked that if the device, but this is a full thickness placator, these are the two arms on which you can add, you can attach the placation, uh, uh, device over here on both, both the sides. And I'll just show you first, uh, how these, uh, placation staples are attached at the tip. And then just to show you in vitro, uh, on a sponge, how we actually, uh, do this placation, there is a small spiral which comes out in between by which we can catch the tissue full thickness, pull it between the two arms. And then by closing, we can apply the staple. So here we are showing you how we apply the staple on the sponge here. So the sponge is put between the device here, and then by applying the staple, uh, you can achieve a full thickness placation. Now this is one such patient of his grade one to two, uh, who had got similar sort of, uh, of, uh, investigations, uh, the result, there was a classical, uh, symptom correlation with GERD. So we place a stiff guide wire in the antrum of the stomach. Then over this, we can load this, uh, uh, full thickness placator device. And inside the channel of the device, we can pass an ultrathin scope. So we can actually monitor what's going on. So we are taking a U-turn with ultrathin scope. Then we can open the two arms of the device and then rotate the handle in such a way that we come towards the lesser curvature area. So we come towards the lesser curvature because we want to achieve a good sling of the greater curvature and enhance the angle of his. So by pushing this spiral device ahead, or this helix, we are going to catch the wall of the stomach and then pull the wall of the stomach in between the two arms. And then as we close it, we are going to rotate this entire handle. And once we rotate it, we fire it. So after we fire it, this is how it looks. So we can achieve a full thickness placation on the lesser curvature. Uh, and by this, we can, uh, get a reasonably good result just to show you how it looks before and after this is how it looks after the procedure, almost similar to how it looks in the TIFF procedure. Uh, so this is before the procedure and this is after the procedure. So there's an excellent enhancement of the angle of his, and it almost looks like a front duplication because we have rotated the whole, uh, area after catching the stomach wall full thickness, we rotate it and then fire it. So this is what I meant by the EFTP device. So these are the two, uh, uh, endoscopic procedures, which we routinely practice in India. Uh, uh, but this can be something similar to the TIFF procedure in the U S. Perfect. Very well demonstrated. Excellent videos for Peter and Felice, some questions on PPI. So Peter, starting off with you, PRN PPIs, do you, you know, recommend that to your patients? I know some patients may be doing it by themselves anyway, but what's been your experience with the use of PRN PPIs? I think it's okay to use PPIs episodically. So use them sort of like three days in a row or seven days in a row or 14 days in a row, but actually to use it in response to a specific, a symptom, when you have the symptom, it's not going to be very effective. It's, it's too delayed an onset of action. You're preventing subsequent episodes of heartburn. You're not treating ones that are already there. Okay. Felice, just following up on that use of H2 blockers. One of the, uh, uh, uh, attendees wants to know that would there be any benefit in adding H2 blockers at bedtime in this patient who was having partial resolution of symptoms? So, you know, you have to find out when the patient's obviously having symptoms, you know, one of the benefits of H2 blockers is being able to take it not associated with meal, uh, PPIs, that can be challenging for patients to take a half an hour before the meal. So H2 blocker before bedtime, especially if they have nighttime wakenings and they're already on BID PPIs, um, that would, you know, I will add that on to a patient's treatment plan. Uh, Ken, uh, post, uh, endoscopic therapy. Do you observe these patients in-house? Is it an outpatient procedure? Any restrictions on diet in the immediate post procedure? Uh, any suggestions there? Yeah, it's a somewhat individualized and a bit evolving. Uh, we used to, uh, insist on 23 hour observation one night, but we've relaxed that and some patients can be discharged soon after discharge. So it ranges from two hours to 23 hours post procedure. And then the, the diet is a little bit, uh, less stringent than after a laparoscopic hernia repair. Uh, they, they go on a full liquid almost right away for about a week and then soft for another couple of weeks. So they're back to solids within close to four weeks. Um, a little bit less, uh, uh, strict than after a hernia repair. Okay, great. Well, uh, guys, thank you very much. Uh, we are about two minutes behind. So I'll, uh, on behalf of Amit and myself, I'd like to wrap up the first section on GERD again. I mean, a wonderful panel, great questions, great discussion.

GERD

treatment options

PPI therapy

endoscopic procedures

symptoms persist

individualized treatment

quality of life