We will next go to Vanderbilt University Medical Center for a pneumatic dilation procedure demonstration by Dr. Michael Bezzi. All right, great. Can you guys hear us? Yes, we can. All right. Yes. Thank you so much. Hello, everybody. I'm really excited to be able to share this with you. I'm here with my colleague, Dr. Patel, who's going to be performing the procedure. Dr. Naik is in the background. He's helping us navigate the audio and everything else that we're doing. So thank you, Dr. Naik. We also have some amazing team here. You know, no procedure is going to be successful without an excellent team. We have our CRNAs, we have our nurses and techs and all the technical people. So I want to thank them as well. So what we're going to do is really talk about pneumatic dilation. We see a lot of patients with echolazia type 1, 2, 3, just like many other expert centers. And Dr. Patel is going to share with us this case where we're planning on doing pneumatic dilation. Dr. Patel? Perfect. We're going to go through the clinical history on this patient. Thank you to ASGE again for giving us this opportunity. So this is a 49-year-old female with dysphagia to both solids and liquids with regurgitation and these are classic symptoms of echolazia. She's had the symptoms since January of 2022 and of course has underwent multiple endoscopy with dilation at outside hospital without any improvement. Similar to a lot of patients with echolazia, unfortunately, due to the regurgitation, a lot of these patients get misdiagnosed as reflux. So they get tried on multiple different PPIs like she has with lentopazolpromotidine. They don't get better. And then eventually they get referred to a tertiary care center, then they'll go work up and they'll get diagnosed with echolazia. So there is a big diagnostic latency in this group of people, just like you see with this patient. So when she came here, she underwent barium esophagram, so we'll go through that next. And this is classic barium esophagram for echolazia. You see this retention of barium in the esophagus and you see this classic bird speaking, which is suggestive, again, hypertonic LES with delayed emptying of the barium. Now, of course, the gold standard test for diagnosis of echolazia is esophageal manometry. So she underwent high-resolution manometry. And this is a classic pattern. What you notice is, again, the lower esophageal sphincter is high pressure. You see impact relaxation. And then the esophageal body shows no peristalsis. And what you see is this panesophageal pressurization, which is very classic for type 2 pattern. So in this patient, we always talk about what treatment options are available, which certainly we have POEM, pneumatic dilation, and heller myotomy that are definitive treatment options. But this patient certainly has some predictive factors that tell us that she might be a good responder to pneumatic dilation, which is she's a young female. She's got a type 2 pattern on barium esophagram. She has a narrow caliber esophagus. And all of those are good predictive factors for pneumatic dilation. So we go through all the treatment options and risks and benefits and allow them to, of course, pick the best option for them. And she wanted to proceed with pneumatic dilation, which is what we're going to do today. Great. Thank you. Go ahead, Dr. Patel. So absolutely, it's nice to have all options available for patients and really tailor treatment for the patient. In this case, Dr. Patel is going to first take a look, make sure everything looks OK. This patient is intubated. And oftentimes, we try to intubate if especially we suspect there's retention of food items and or saliva. This is a case of type 2, as Dr. Patel mentioned. Type 3 cases, we rarely do pneumatic dilations on, given all the data that are now available that really for that group, polum would be ideal. And if not polum, then myotomy. Dr. Patel, explain what you're seeing. Yeah, so here you kind of see the classic appearance of echolasia, where you see this dilated movement of the esophagus. You see this stasis esophagitis changes in the esophagus. So whenever you're doing an endoscopy and you see that, you should be concerned about it. Here's kind of classic. You see the puckering of the LES, which is kind of hypertonic. And then the best thing here is you want to be able to kind of pass through the LES with just gentle pressure. If you notice that you have to use excessive pressure, you're having a hard time passing the upper endoscope, then you have to worry about infiltrated malignancy, because really the key of upper endoscopy in this group of patients is to make sure it's not pseudo echolasia. And a lot of times the feel of the upper endoscope as it's passing through the LES is very key. So we're obviously finishing here the upper endoscopy, looking at her duodenum, pylorus stomach. Now, the second part that's key during endoscopic exam is, of course, making sure you get a good view of the fundus and the cardia. So here's a retroflex view. You get a good view of the fundus there. And then you want to kind of get a good 360 view, get a good look at the cardia right there. And that kind of gives you reassurance that this is not pseudo echolasia. And that's always important. The next part of this pneumatic dilation is we put the savory guide wire into the stomach. This is very common, commonly done, of course, with savory dilation. One of the things to mention, Dr. Patel was talking about pseudo echolasia. Sometimes you see a mass effect, but sometimes it's really that pressurization, i.e. when you're trying to go from the GE junction into the stomach, it just feels much tighter. The patient has lost more weight than they should for echolasia in a short time period. So be very cognizant of that. If it's tighter to push through, patient's lost a lot of weight, older patient, you may want to not do this, obviously, and do your work up for potential pseudo echolasia, which manometrically and by variant would look identical to what was shown in this case. And right now, Dr. Patel is putting the savory guide wire through. He's noticed where the GE junction is. So next, he's going to put the pneumatic dilator through. As we know, there are three sizes. We have the three centimeter, three and a half, and the four centimeter balloon. We typically start with the small balloon. This is a three centimeter balloon. So here's the classic pneumatic dilator balloon. So you'll see this radiopig markers. So the two radiopig markers that are right in the middle of the balloon, that's where you want the lower esophageal sphincter to be positioned. So that's our marker. Obviously, this procedure was done previously with fluoroscopic guidance. So that's where the markers were positioned. But now, we do it primarily with endoscopic guidance, because you can use endoscopy markers to position those two radiopig markers right at the LES. And obviously, that reduces some of the time you need with the procedure, along with being able to reliably do it as well. And you can assess post dilation without having to use fluoro, which obviously increases not only cost burden on the patient, but also the time needed. So here, we have the pneumatic balloon that's positioned over the guide wire. We like to make sure it's well lubricated, because obviously, it's a balloon that's hard to pass. So we have the balloon that's being held. So we're now going to pass it over the guide wire. Yeah, and as Dr. Patel is passing this and making sure it's in the right place, he talked about endoscopic dilation versus fluoroscopic. Both are OK. Whichever one is comfortable with. Obviously, this technique should not be done at centers that don't do enough of this. This should really be reserved for places where there's experience and backup. As we talked about, there is a risk of perforation with pneumatic dilation. That can be 1% to 2%. It used to be that we talked about it being as high as 5%. But anytime we do this, there is that risk. There's no predictor of perforation. So after we do the dilation, we always look for that. And prior to doing the test, we always ensure that we have a fully covered stent available in case afterwards we see a tear that's more than we normally visualize. I've done the direct endoscopic dilation now for more than 20 years. I started doing it when I was in Cleveland and now here. And I find it easier, but also as effective. And it has not necessarily changed any of the perforation. I.e., it doesn't increase or decrease the rate of perforation. Perfect. So this is where the balloon's right at the LES right here. So we know this because we measured where the LES was when we did the endoscopy, which is right at 35 centimeters. So what we're going to do is retract the balloon here. And you're trying to get an idea of positioning, again, those two sensors right at the LES. Again, we're just retracting that balloon. Do you see that marker right there? And what he's essentially looking for are the two markers to position right at the g-junction, just like fluoroscopically, we would move the balloon to ensure that those two markers are at the g-junction. So here's the first marker. You see, here's the second one. Here's the second. So again, you're positioning it right at the g-junction, which you know it's right there. So those markers are well positioned. So now you kind of come back and we're going to put our endoscope down. And at this point, we're going to connect so that we could do the pneumatic dilation. All right. And so here, the key part is, of course, the nurse is going to hold the pneumatic balloon in place as you're inflating. Here's the pneumatic dilator. So again, what we're trying to do is we're going to go up slow on the pressure. And you kind of see here. And the goal is to get to about 12 psi. So we're slowly going up as we're doing this. And one of the things to be cognizant of is that when you start increasing the balloon, the balloon is going to have a natural tendency to go forward. So you want to hold it tight so that it doesn't make that forward movement. But the positioning of the balloon, we're going to verify after the balloon is inflated through the look of the balloon after the inflation. So here, we're at 12 psi. You kind of see here. Now, this balloon, because they're RigiFlex, it's important to realize you can put more pressure in. The balloon is only going to go up to 3 centimeters, which is the balloon we'll use. So here, we're at 12 psi. So we're going to put it down. We'll show you the endoscopic view of the balloon. All right. So here are the markers. And then you see those two radiopig markers right there, right at the alias. And that's a great view. So you really want to make sure you're positioned correct. And if you're not positioned correct, you let the balloon down, reposition. We're at 12 psi. The question has always come up is, why is it that should it be 12 psi? Should it be higher or lower? I know our European colleagues, especially the two studies comparing pneumatic dilation to myotomy and foam, were using much less. They were using 5 to 7 to 8 psi. We typically don't do any less than 12 psi. So maybe the difference in efficacy could be from being able to really dilate to the maximum size. The next question, Dr. Patel, is how long do you leave the balloon inflated once you've achieved? Yeah, this is variable. We keep it typically from 15 to 30 seconds. So here it's been enough time. So now we're going to deflate. So I'll let go. We're going to disconnect this. And then we want to, before we withdraw, we want to make sure the balloon's nice and deflated. So you can use an empty 60 cc syringe and then remove any air. Now we're just going to remove this balloon. The balloon is removed. But the most important part, and you can kind of see some blood right there. And you do want to see that. One time I was giving a lecture and our surgical colleagues were saying, well, that's so barbaric to see blood on a balloon. But, you know, I just wanted to remind everyone that to us that means efficacy and to our surgical colleagues that that is what they see. That's right. So here we are. So here we're at the bottom. And so here you just want to make sure now that we're going to look at this LES. So normally when we evaluate this area of post-pneumatic balloon, you can see it's much easier to pass now. We like to switch to CO2 just in case, of course, there is any deeper tear in that area. And we always are ready. So here we're looking at this lower self-dosed sphincter. We're going to try to add some water here. And so, again, here's the tear. You kind of see at the bottom. So, Dr. Avesi and Dr. Patel, do you guys ever in one session decide to go up a balloon size or is that usually left up to post-procedure follow up and based on symptoms? Yeah, I know our European colleagues at times do one and then they go to the next. But our practice, at least my practice over the past 25 years, has really been to do one size. And we decide that size based on patient presentation. If this was a younger male and they had picked to do pneumatic, I would not start with a three because our studies have shown that three and a half start would be better for that group. But we normally just do one balloon size as we've already predetermined. But the most important, as Dr. Patel highlighted, is to really go to at least 12 PSI, 12 to 15, and not less because the efficacy of this is going to be similar to if you do a palm and or laparoscopic myotomy, but you don't do a full myotomy. And it's really the pressure that's going to determine whether or not you're achieving a fuller myotomy. And if you do only five to seven, you may not be achieving that. Yeah, that's exactly correct. I mean, I think for someone like her, who's a treatment naive patient, the plan, our goal has always been to start with 30 millimeter balloon. Primarily there's two reasons. One is, of course, the risk of perforation is lower if you use 30 millimeter balloon as an initial balloon compared to starting at 35. Secondly, if there are predictive factors, like it's a young male who wants to do a pneumatic dilation, they tend to have a thicker muscle, you might go a size up. But I think usually it's a good idea to start with 30. It is important to realize, of course, that these pneumatic dilation is serial, right? So you follow up with the patient in a couple of weeks, see if they're still symptomatic. If they're still symptomatic and bring them back, go on to the next size. But significant number of patients, particularly if they're young female, narrow caliber esophagus type two pattern, do tend to do better with just 30. And it reduces your risk of perforation on that initial endoscopy. And so we do, of course, you know, we looked at that area of post dilation, looks great. But we're always ready. So we always have stents in the room that are fully covered, that we're ready to deploy if you do see a perforation, so you should be always be ready for that. But we just finished a case actually, right before this, where I had dilated, done a pneumatic dilation on this patient, about seven to eight years ago. So that gives you an idea of the efficacy. We follow the patient once initially in a month, and then once a year, but with barium swallow and symptoms, patients tend to do well. We used to, when we did pneumatic dilation, we'd actually admit the patients to the hospital. This is ages ago. We no longer do that. We used to order barium swallows afterwards, gastrographin and barium. We don't do that either, depending on the endoscopic view, as Dr. Patel showed you. So this patient, the plan will be to extubate and then monitor for the next 30 minutes or so in recovery, make sure everything's okay. If any chest pain, obviously they'll be worked up for perforation. But as you saw, the endoscopic view is really most important. And this really went well. So welcome Dr. Patel. I think, yeah, I think it's important to recognize, of course, you can see that pneumatic dilation, of course, if you do endoscopic guidance, can be done in 10 to 15 minutes with endoscopic positioning of the balloon. And that's important, of course, from a practice perspective, safety perspective, it has equivalence, of course, to fluoroscopic guidance. You don't have to have a lot of equipment and manpower to do a fluoroscopic guidance. So I think it's important to adapt to endoscopic guidance, if you feel comfortable, of course, with that approach. Yeah. Hey, Michael, I have a question. This was a beautiful demonstration. So the manufacturer recommends 20 PSIs, I do 20 PSIs. So why do you only go to 12? I don't, we don't necessarily just go to 12, we go to, again, you know, the view you saw was the most important, which is through the balloon, you should go to minimum of 12, as I was highlighting, because a lot of people, they just go to five to seven PSI, the most important part of pneumatic dilation, whether you do it fluoroscopically or endoscopically, is obliteration of that waste. And you can see that through your balloon. So when Dr. Patel looked through the balloon, if there was any waste, he would have gone higher PSI. So I don't personally like to just go to 20, or just go to 15. We like to use the waste obliteration as a guide, and endoscopically, we can see it. And you can also, obviously, if you're doing fluoroscopy. So there's a range that we use, and all of that depends on obliteration of the waste. But that's a great question. Yep. And I think, Dr. Kashab, it's completely reasonable. I mean, I think these balloons, of course, go to set size. So I think it's, we, of course, keep putting the pressure in. And if you feel like, okay, now it's not really expanding, then you don't necessarily have to put more PSI. But it's completely reasonable. You can go into any of that range. So two more quick questions. Yeah. So the second question is, you know, the old teaching is you get an esophagram before you discharge patients. And the third question is, what do you think of putting a cap on the scope to assess the effect and make sure there is no perforation, especially in questionable cases? Yeah. So we used to do that as far as ordering barium right before discharge. And, you know, this was, this is maybe about 10, 15 years ago where that practice has changed. Nothing wrong with doing that. If you like to do that, to just be certain, absolutely. For us, we really use how well the procedure went, how visually, how well the GE junction looks. And again, whatever you're comfortable with. If that is what you like to do is put a cap in to visualize, to ensure nothing wrong with that. Remembering one thing, the patients that don't perforate, in this case, everything went really well. Sometimes that patient goes home and has a nausea or vomiting. And I had one case in the past 20 years where that happened and they open up that area. So the delayed perforation can also happen. Everything went well. That patient, for example, we've done that 15 years ago, got a barium swallow post procedure. Everything went well, went home and vomited and then developed the perforation. So the point being, whatever you're comfortable with, that's fine. Using a cap is okay. If you like to do that, you're comfortable doing that to ensure that there's the level of the dilation you've done is not too deep. Sometimes it's an art, as you know, about what is too deep. But I promise you when there's a perforation, you will not miss that because that opening is scary. Dr. Patel, have you had one of those that you've seen? Definitely I have seen one, but not likely with pneumatic dilation yet. But no, that is exactly correct. I think we've all seen those perforations. You'll clearly be able to identify it. One of the other ways you can obviously save, you can have loss of fresh expansion of the esophagus. You're not really able to distend as easily. That's again a marker that yes, there is a hole somewhere and you should use additional tools like a cap to make sure you don't see it and treat it. That's I think the key component for us now is with the advancement of tools we have, complications are no longer considered to be a scary thing for us. Sometimes we intentionally create complications like Dr. Kashab I'm sure does on a daily basis, but you're able to kind of close those complications because it's for an intention to provide therapy for the patient. Yeah. Prior to this case, I may have mentioned, we did a case of a patient that we had dilated and again, she did really well. That was a three and a half centimeter for about six, seven years. So again, the efficacy I expect from this dilation is about that. And what we tell patients, we don't have a cure, right? None of these therapies for Echolasia are cures. So at some point, they're going to revisit these options again about what to do. So what I expect this patient is to do well for the next, hopefully six, seven years, but be back for weekly dialysis. I would love to ask our moderators here, both Dr. Clark and Dr. Shen, which patients do you send for pneumatic dilation or you do pneumatic dilation on or which patients do you send out for POEM? Let's make it a little controversial here. Yeah. So, so we, we, we don't do as many pneumatics now as, as, as we, we had maybe five years back. I think POEM has really taken over. Most of the people that I do are first time people who are, who tend to be past 60 and in most cases, and don't, don't, don't want anything requiring admission since we do keep patients one night after POEM. I'd say more often though, now I'm doing pneumatics in people who have had a prior POEM, prior Heller and have symptom recurrence afterwards. So in, in terms of now, I'd, I'd, I'd say maybe, you know, 10 to 15 a year total, but probably 70% of them are people who've had Heller versus POEM prior. And I would agree. I think over the years I've seen a, you know, just an upswing in how many patients we refer for a POEM, even Heller myotomy comparing to pneumatic dil. Definitely my type three achalasias, I'm not giving them, you know, pneumatic dil as a, as a favorable option. I, you know, I do leave a lot of it otherwise up to the patient. There are patients that are coming in, having heard POEM that want POEM and, you know, I still mentioned the other two, but that's, it's not going to change their minds, but it's pretty much, I think it's a, you know, presenting the option and it's self, it becomes still pretty much a patient-centered decision, shared decision. Yeah. You know, one of the things I will highlight to that, to that end is if your center specializes in POEM and less so pneumatic, then you should lean more toward POEM. It really is, our center specializes, at least we have the expertise for all three, and we look at those options equal other than in type three patients. So that's why we're fortunate enough to do that. But I agree that if you predominantly do POEM or if you predominantly do myotomy, that's what you should be leaning toward in your center. Yes. And you know, there is an ASG guideline on this from a couple of years ago that endorses all three treatments, heller myotomy, pneumatic dilation, and POEM as acceptable options. So, and yes, that will determine, that should be determined by local expertise. So my other question to also the moderators and the Vanderbilt team, here we saw that they started with 30 millimeter dilation. When do you start with 35 and when do you ever go to 40? So Dr. Shen, I'll start with you. I will say that I've never recommended a 40 just because of the risk of perforation. We usually do 30 and, you know, especially in my patients that are potentially poor surgical candidates in case of complication, sometimes even repeating a 30, you know, before we go to 35. Yeah, we're pretty similar. You know, I think 40, your risk of perforation in most studies is about 5% at that volume. And I think given that we've got good options with heller and POEM, it just seems like there's never really a role for going there in my practice. You know, I do think the data is pretty consistent that 35 is good to start if you have multiple predictors for not doing well with 30. And so if you're a young man, you know, that's probably a better scenario to start directly at 35. I'll say in my practice, similar to Dr. Chen, I generally start 30. You know, I think that the risk is lower. Some patients do very well at 30. And my sense, and it might be my own talent, is that I like starting that first. And then if they don't respond appropriately, I can always go back up a month or two afterwards with it. Two quick questions to ask as well. Someone texted me to ask if you take them to 30 and you don't see any trauma or tear whatsoever, you know, do you ever go towards 35 in that same session? Or do you think there might be some deeper injury that isn't reflected within a mucosal disruption? So that's first question to Michael. And then the second question is, you know, I'm really impressed by doing this without fluoro. And I'll, you know, I know that that's not done that often across the country. It seemed very elegant and slick the way they had done it. And they obviously have a lot of experience doing it and doing it safely. But my questions for that would be, A, do you think that's something that, you know, other centers could do across, you know, could do a pretty much across the world? Or is there any sort of risk in terms of lawsuits or other things along those lines? If you have a perforation, you didn't have fluoro. And you know, with that, is there a learning curve towards going with fluoro? And last question with that, any other centers they're aware of within the U.S. doing it without fluoro? Michael, wait, Michael, please, two minutes before we move to the next center, they're ready. Yes, we rarely go in the same session, balloon size up, we always bring the patient back. So we start with one and go to the next. As far as endoscopic, the rate of perforation is not, we're not actually involved. In fact, if you look at the ACG guidelines that we wrote, we suggest that you could do fluoro or endoscopic. And there are other centers and publications in that. So we're not the only center, we're probably the center that has the most experience. But if you're not comfortable with that, don't do it that way. You want to get comfortable, obviously, learn it and then start doing it. But from my perspective, I don't see necessarily one being better than the other. It's just different and what you're comfortable with them. Yeah, no, I totally agree. I think it all comes to comfort levels. But I think the goal is, if you're interested in, of course, learning it, it does, it is easier from a manpower perspective. It's easier from resources perspective and the amount of time it takes you to do it. So I think, again, you always, you should always do the technique you're most comfortable with. But I think it's a better, it's an option that's certainly easier. Yeah, I mean, medically, again, ACG guidelines become your medical legal. Cool, cool, cool. Thank you. All right. Well, before we go, I know we don't have much time. I really wanted to thank our team here, Dr. Nag, Dr. Patel. We have our excellent CRNA, Allison. And we have Jan on nurse and Tom, our technician. And Tom, our IT, as well as our other IT individuals. Again, it took a lot of time and also ACG for having us do this. Again, thank you guys for allowing us to show you our technique. Thank you, Vanderbilt team. That was an excellent presentation.

video

Dr. Michael Bezzi

Vanderbilt University Medical Center

pneumatic dilation procedure

achylasia

Dr. Patel

Dr. Naik