Presented by Reginald C.W. Bell MD, FACS, SurgOne Foregut Institute, Englewood, CO.
good day. On behalf of sandhill Scientific, I'd like to welcome everyone to our webinar on interventional good therapy. Before Dr Bell begins, I'd like to handle a few organizational matters. Everyone at this point is muted to control sound quality. The event the event is being recorded, and any participant or a colleague can listen to this event at a later time by accessing the sandhill scientific website. If you have a question during Dr Bell's presentation, please type it into the question field at the bottom of your screen. My assistant, Wendy O Connor, will be monitoring the questions, and she will read them to Dr Bell at the end of the presentation. Dr. Bell will be speaking for approximately 45 minutes, and we will have 15 minutes at the end for your questions and Dr Bell's responses. For those of you that may not know, Dr Bell, he's a forget surgeon in Denver, Colorado, that's highly experienced in interventional good therapy. He routinely does collaboration with the product development companies and does validation research in these techniques. Dr. Bell, Uh huh. Jerry, thanks so much for allowing me Thio. Participate today One second here. Wait and Um, yeah. So I have been fortunate enough in my practice to be able to specialize in interventional therapies, and I wanted to share kind of our perspective on things with you very much. Have appreciated working with Santel over the years. They've been very dedicated to educating providers, nurses about the testing procedures that we use in evaluating patients with GERD, and I'm happy to be part of that process. So I'm gonna talk about whether there is and what the need is for interventional dirt therapies. I'm gonna talk about the current status of interventional therapies, including Trans Orel fund Implication the links procedure. Muse El es stimulation with the Indo stem and summarize a little bit about laproscopic fund application and talk to him about diagnostic evaluation in patient selection. Thank you. So I'm a forget surgeon, and our practice is really one where we're interested in the diagnosis and minimally invasive treatment of esophageal and gastric disorders. And we've been ableto pull together some comprehensive and centralized diagnostic testing, including doing motility, impedance ph, testing, gastric and whole gut transit times and trans nasal endoscopy in our office. And we've been involved in some new innovative technologies and have really been able to be do some clinical research, which has been a lot of fun. We do about 250 anti reflux or Heidel hernia or re operations annually. We were the first in Colorado to do the links procedure back in 2010. We have the privilege of going to Brussels and operating with Professor Gilbert Qadeer, uh, doing some of the trans oral fund implications of a live presentation to about 50 European surgeons. So what's the need for interventional therapy for GERD? Well, we know that reflux effects one and 10 patients on a weekly basis and a large number of patients on a regular basis lifestyle modification and asked. Its oppressive medication comprised 95% of therapies for Gert. But we know by multiple reports from the gastroenterologist that 30 to 50% of patients on PP ice just aren't happy or satisfied with the results of their therapy. And so there is a therapy gap now. I think Peter Carolus comment is very appropriate here. It's been proposed by some gastro neurologist that failure to control symptoms by proton pump inhibitors implies that the symptoms were not related to GERD and this is not true. And in fact, back in 2002 of Don Castel, many of you know did this study looking at ISA members, all online soap resolved and looked at percent of patients reporting sustained symptom resolution, and only 70% of patients who had mild reflux esophagitis reported resolution of their heartburn on 40 mg of PPS daily. Somehow we seem to have ignored that and think that 95% of patients are treated adequately, and not much has changed since then. So maybe there's a problem here. Esophageal cancer is increasing more rapidly than any other cancer in the Western world, and it's only going to increase. The incidents of esophageal cancer parallels the incidents of Barrett's esophagus, and this parallels the use of acid suppressive medication. So even if PPS aren't causing cancer, and actually some people think that they may be contributing to the increase in barrettes, which leads to the increase in cancer, I think it's fair to say that PP eyes were not stopping yet by any means. And in fact, here's some recent articles, PP ice or they the culprit for barrettes, esophagus. They may not prevent high grade dysplasia in patients who have barrettes. So maybe there's a problem here with our approach to the treatment of reflux. So this is how we currently treat GERD. We look at prevalence and severity on two different axes. We presume that medical management is successful in 95% of patients, and maybe one or 2% of patients will get a laparoscopic from the application to control center. What the data shows is that there is this therapy gap where medications are simply not working. We need something better in this area, and to me, the fundamental problem is that assets oppressive medication doesn't treat reflux. It simply reduces the acidity of the reflexive. It doesn't alter the frequency of reflux events, and I kind of remind people it's good. Gastroesophageal reflux disease Not geared. It's not gastroesophageal acid reflux disease. So what causes good? Well, to me, it's clearly an ineffective gastroesophageal junction. That's what allows her toe happen. And conceptually, there are three components in the junction that helped prevent reflux. There's an intrinsic pressure in the lower esophagus. There's a flat valve mechanism and there's a diaphragmatic pinch, and I put the intrinsic pressure of the L. E s and the flap out mechanism, I kind of liken it to a whoopee cushion. So reflux is a mechanical issue. And although it's taught that the major mechanism of reflux are these neurologically mediated transient el es relax ations, I think there's growing evidence that these t L E s ours are associated with lower esophageal sphincter shortening. And so decrease competence. Competency of this whoopee cushion type fell. So it's the length and the pressure and a little bit the angle ation. All of those grew into the function of the lower esophageal, sphincter slash DJ Junction and the surgeons. We know that pretty well because we see this anatomically so there's a normal valve that'll close to prevent reflux in this dysfunctional valve that stays open because it has a bad shape. It's got a short length, and it's got a week pressure or all three of those we often neglect. How much? Ah Heidel Hurriya disrupts the Asafa Go gastric junction, so normal anatomy shows the scope in retro flex showing this flat valve mechanism and if you dissected further anatomically, there are the sling fibers that go across between the lesser curve and the angle of hiss that help tighten up the sphincter muscle along with this angle ation or flap valve like flat mechanism. So something closes during this, as pressure increases toe help decrease the amount of reflux that occurs, and it keeps the sphincter longer. When ah Heidel hernia occurs, we instead get a funnel shaped valve that lets stomach Jews come back up very readily becomes an incompetent sphincter mechanism. So Heidel hernia effects this optical gastric junction competency by creating a funnel at the top man. It creates an and a chamber where fluid and food sit, and sometimes they're more likely to reflux before they pass through this and have a chamber into the main body of the stomach. The pinch mechanism of the diaphragm is displaced, and what I mean by that is that the curl fibers right around the esophagus contract a few 100 milliseconds before the rest of the diaphragm does during an inspiration. So during an inspiration, you create a negative interest or a stick pressure that would favor reflects by having the Pearl Fibers contract a few 100 milliseconds. Before that, the esophagus is pinched in a normal situation during that or just before that breath. If that diaphragmatic pinches displaced onto the stomach, then you're actually creating a larger and a chamber. It will lead to REFILES, and as the highest widens, we get a full lack of that diaphragmatic pinch. And so we get a pure funnel shaped valve mechanism. So to me, treating the cause of reflects really does require thinking about a procedure, not a pill. That treatment needs to reestablish e g J competency by accentuating the flap valve mechanism. Decreasing Elliott shortening and yields pressure needs to restore the diaphragmatic component if it's disrupted, so you need to reduce the herniated stomach. And if it's widened, you need to bring the coral diaphragm into proximity with the esophagus. Now Laproscopic Front Apply Occasion is known to be very successful, a controlling reflux even in the long term, when it's performed by experienced centers. One of the issues we have is that across the country, oftentimes is performed by certain to do 2 to 5 a year, and that may not give us the best results. It's a reconstructive procedure, and it requires experience and dedication. But it has a bad rap. This even when it's done well, it has side effects of gloating, swallowing issues, pain that may be partly related to searchable expertise. But I think it's partly intrinsic to the procedure. A missin funded qualification creates a super competent flap valve, and that's a problem means that people can't vomit. They have difficulty belching. There's air trapping. So our personal experience is over 2000 laproscopic on the application and over 25 years in practice, we refined this so that we have pretty minimal peri operative complications. We've got excellent success of controlling reflects, and if we ask patients, 90% of them are very satisfied with the results. That means that 10% or maybe not as happy as they wish they were. To me, a laparoscopic from the application is fantastic for patients who have horrible reflux complications such as aspiration, asthma and things like that. But some patients were still bothered by these side effects. Increased flatulence problems with bloating or diarrhea, nausea, inability to so to me. Maybe there's a problem with our traditional surgical treatment of reflux, just like there's a problem with the traditional medical therapy for vehicles. The current role of anti reflects procedures is really minuscule and doesn't cover it. All this patient population and whom that you're not working. And to me, this is where minimally invasive interventions have a significant potential. So what do we need to do, Geo? Fill this therapy cap? Well, procedures need to be less invasive or destructive. We need to decrease the side effect profile. So we need to enable belching and vomiting. We need to minimize bloating, diarrhea, nausea, side effects being with microscopic fund application as well as the dis pager. We need to demonstrate that they're effective and have your ability. So where are we in all this? Well, one of our first sort of clinical research projects was getting evolved in trans Orel incision was funded application. So device inserted through the mouth over an endoscope that brings the fund ist of the stomach up against the distal esophagus and secures it in place with little age shape fasteners. Uh, so, using a tissue mold in retro flex here we bring the stomach up against the esophagus, and then we place these little H shaped fasteners from the esophageal Lumet through the gastric wall and then the unfolds, kind of like when you buy clothes, those little H shaped tags that holds some of the our tags in place. So this is a video of doing the procedure with a newer device, Um, that is done with a pediatric scope. So when you look at this in retro flex, the valve may seem a little bigger than normal. But that's partly because we're using about a seven millimeter scope through this. And with this newer device, it's been simplified significantly in terms of how easy it is to use the controls externally. It also enables us to, uh, deploy the fasteners without having to visualize them coming out, which enables us to rotate this device mawr into what we call the corners and then fire these fasteners, creating what starts to look like a fund of application internally. Now, with the scope in place, it looks like very much like a nissen. Once the scope is removed in a month or so have gone by. A lot of this swelling goes down, and it looks really more like a hill one or a normal valve mechanism. Thin this with a little bit of additional book to it. Rather than looking completely like a miss in front of application. And because we're doing it internally, we're doing it symmetrically. We found that the side effect profile is significantly less than with missing procedure. So and right now, what we're doing is we're firing fasteners along the post. Your your edge, little cubicle retractor is being withdrawn and you can see here little dimples from where the H fasteners are within the esophageal looming and the final booked up L E s on retro flex view. Here we can see little indentations from where the fasteners have been deployed on the cardia stomach. If we do a laproscopic view, we actually see that we are indeed taking part of the stomach and folding it up over the distal esophagus and proximal stomach. So it's sort of mimics what we call a door fund a publication so symptomatically we've seen very good results in terms of improvement in what's called the GERD HR QL score, which is a 10 set of 10 questions about heartburn. His fage pain on swallowing. Also, improvement in regurgitation scores reflect symptom index which measures LPR type symptoms. Learn Joe for angel reflects symptoms and the gastroesophageal reflects score these have been sustained out to 24 months in a multi center study that we were involved with. We also looked at how tiff performed objectively, and we saw that it decreased the number of reflux episodes in almost 90% of patients at six months follow up. And when we looked at side effects from the tiff procedure, we saw that bloating and flatulence globally decreased across 100 patients and really Onley. One patient reported increased bloating in that whole cohort. Satisfaction with current condition improves significantly as well. But to me, the most important part is that the bloating and flatulence globally increased only increased in one out of 100 patients. There have been a number of recent studies on the procedure. It's been prospectively studied in randomized, controlled, even a sham randomized controlled crossover trial. And I won't go over the details of those studies. But Phil Cats and critique Sharma Andi. I think many of you know both of them. Fill is a pretty conservative gastroenterologist when it comes toe wanting to take on new therapies. Um, and his comments and critiques is very cogent. I think that is that although longer, follow up of this cohort and the respect study is needed. It seems that these results with the trans oral funding application device make it a viable options for treatment in selected, well informed patients and puts into Scott pick therapy back in the game. That's a big change from where we were a few years ago, and I'm delighted to see that. So to summarize on the tip, lack of side effects is extremely important. It offers ah, lower degree of reflux control globally. Probably about 70% of patients find that they have a very good result in terms of being able to get off PP ice not have ongoing GERD symptoms. It's the only endoscopic procedure today that has resulted in normalization of pH in the majority of patients. The n D apply Cater did not, nor did the Endo cinch. It's excellent for patients who have minimal to me less than or equal to one centimeter Heidel hernia and who have breakthrough despite PPS. So it's one procedure in our quiver. The Muse device has been recently FDA cleared. It's a different version of a trans Orel end Luminal device that creates in the soft gastric funding application. So it works in a similar fashion to a tiff accepted. It deploys Staples instead of these H shaped fasteners. I have not used it, Um, but in the data that's been reported, it did not normalize pH. There's not a lot of durability to know if the Staples air any better than the H fasteners of the Asaf ICS procedure. Since I haven't used it, I'll give you the details of having used it. I expect you to have read that in two seconds and know exactly how to do it. Uh, that's all I'll say about the Muse. The links procedure is very intriguing. It's this bracelet of magnetic beads that air held together bye little titanium wires that air placed during laparoscopic surgery around it is still a softens mechanism of action. Well, it augments the lower esophageal sitting through without creating this sort of super physiologic flap valve of innocents. If you remember, the lower software sphincter at rest is typically closed, and it's placed non compressive lee around the lower esophageal sphincter. The magnet give the pressure is about 25 millimeters of mercury pressure. That's how much it takes the pop, the magnets apart. So during normal swallowing, where we generate pressures of 45 millimeters of mercury on up, there's enough pressure to open up the magnets and allow passage of Ebola's. Then the magnets come back together, and they make it harder for the lower soft oils, finger toe open and most reflexes passive. That occurs with the pressure ingredient of about 12 millimeters of mercury pressure. That's the pressure radiant between the abdomen and thorax. So the links keeps the L. E s closed during passive opening of the lower esophageal sphincter. And it also limits the shortening of the L ES that occurs with gastric distension. And so it decreases postprandial reflux by that mechanism. So this is, uh, a short video of how we place this surgically. Uh, we do, Ah, laparoscopy. We identify the stomach, the esophagus and the diaphragm. We free up the peritoneal reflection that comes from the diaphragm over the esophagus and the stomach. We get back into the, uh, lesser sac. We identify the poster, your vagus nerve, which I'm dissecting out right here and in this patient without a big Heidel Hurney, we do very minimal dissection. Uh huh. Off the rest of the free no asse official membrane. We then place a little sizing magnet around the pistol esophagus, choosing anywhere between 13 and and 17 beads on the links device for different sizes of the esophagus. We bring that around between the posterior Vegas and the esophagus to help hold it in place, and then it clasps together with a couple of magnetic clasps. The procedure went down in a patient who doesn't have a big Hilal. Hernia is fairly fast. It takes about 30 minutes to do. It seems to hurt less than a missin fund, a publication even when we fix Ah Heidel hernia. Many of these patients go home the same day as opposed to staying overnight, which they would with a missing. So I think it is less invasive, even though it's a Lappas capital procedure. So if we look at 100 patients partially responsive to PP ice five year outcome available on 85 of these patients and look at outcomes, what we find is that there is significant durability out to five years in terms of relief of troublesome heartburn, troublesome regurgitation, Daily PP. I use and dissatisfaction with quality of life, all of those improved dramatically at first year, follow up and maintain a very linear profile out to five years. And this is actually really interesting because it's different than what we see with this and funded application where there's a gradual tapering off of success. Over time, this fija has gone down significantly floating and gassy. Feeling diarrhea have gone down along with problems with nausea and vomiting. In this procedure, if you look at quality of life, the studies were done in patients who are partial PP I responders. So all patients had a quality of life has 10, uh, set of questions administered prior to the procedure both on and off PP. I therapy and then at five years and you can see that compared to even on PP therapy prior to surgery of five years, there is still a dramatic improvement in quality of life. Generally, we consider a greater than 50% improvement in quality of life to indicate successful therapeutic intervention. At five years, there were a few patients who are still on PPS, but the medium quality of life score that they had when they were asked to stop their PPS with seven suggesting that they were on PPS, but it really doesn't make a difference in how they felt. We see this not uncommonly after anti reflux procedures patients or placed back on PP ice. They don't notice much difference because three quarters of these patients at least don't have ongoing reflex side effects from the links. Compared to the missing. This was a retrospective mashed cohort study from USC. Mild to moderate bloating was equivalent between the two, but in the links, who was actually only mild bloating, severe bloating was almost absent in the links group, versus about 10% in the mission group. Difficulty belching or unable to belch was significantly last in the links procedure compared to the missing procedure, and issues with this pages were fairly similar in about 10%. Most of these simply patients reporting that there were certain foods that they had problems eating or they wouldn't go down easily. So in comparison to a laproscopic listen, ability to get off PP ice and control of heartburn is as good, if not maybe better than a missing five years without the severe side effects of bloating and difficulty belching. The newest version of the links is approved for 1.5. Tesla's Emery Most outpatient memories or 1.5 Tesla. If a patient were to need a three Tesla Emery, um, it wouldn't rip the links out of the body like an Aztec warrior. Sacrifice. Um, it simply my de magnetize a couple of the magnets, leading to some loss of, uh, ability of the length to control lower esophageal sphincter. Opening 3 to 6% X plantation rate has been reported. Most of the X plants have been due to patients who have problems swallowing or chest pain. His ex plants have been done very easily. Some of the patients have had at the same time a laproscopic from the application. I think as time goes by, this ex plant rate will probably come down to the 3% range. We understand better how to manage issues with this page after surgery, everyone has been concerned about the potential for erosion of a foreign body into the esophagus, and it has happened. It's been about three and 1000. Most of these have been removed either endoscopic lee or laparoscopically without incident. Seems like if you remove from endoscopic Lee, you can cut the be the wire between the two beach and then oftentimes simply pull the links out. Then the body will heal around it if it's done laparoscopically. Similarly, you cut over the capsule that has formed over the links. Cut one of the wires, pull them beat out, put a drain and and typically, the drainage stops within 24 hours. Body heals this over very, very quickly. Some of these patients have actually gone on to have a fund, a publication later on with good results. So I had reflux for 15 years. A year ago, I had a Lynx procedure done by John Lip. Um, who was one of the original investigators out of USC had not one single, PP I since surgery. I was on 40 mg. A day prior to surgery, I had the Mr Score of 69. Um, when I was off my peopie ice for a week, I had rodeina fada horrible pain that two episodes of regurgitation since then, after a big meal on a wet burp on guy know now what regurgitation tastes like when you don't have PP is on board, and it really does burn and so forth have no heartburn or regurgitation beyond that, and I just will say that I've never looked good in any kind of a hat. So the links augments Elliott's resistance to reflux without creating a flap. Val. So post bundle application gas blow really has not been an issue. The durability appears excellent and maybe better than a mission. It requires adequate Paracelsus to clear Ebola's. There is some this pager. But as we learned how to manage the full stop diet to improve the capsule or pliability, this has been less of an issue. What I mean by that is the body forms capsule or start tissue around this implant, making it harder for it. Thio open up, and that occurs primarily in the first 4 to 8 weeks after the procedure. So it's important during that time frame to keep this scar tissue pliable by taking small bites frequently. So it's all patients have a bite or two of tablespoon or two of yogurt every hour while you're away to keep this supple. And once we've done that, we've noticed that are dis major rates, and our need for dilation went from five out of the 1st 10 to 1 out of the last 70 patients. It's been said that Heidel hernia is a contra indication to the length, and I'd like to mention that Heidel hernia is actually listed as a precaution in the indications for use, just like a P p. I is not indicated form or than six weeks. That simply means that it has not been studied and then that study data has not has not been presented to the FDA to get clearance or beyond six weeks. But we all know the PP has been used for longer than six weeks throughout the world. So there is a difference between a contra indication in something that has not passed the FDA, uh, indication for use Heidel hernias or precaution and ongoing studies indicate similar results. Whether or not there is a hernia of it is repaired. And in fact, the hernia that I had was about five centimeters. Uh, AP dimension at the time of surgery Handle stand is something you'll probably be hearing about in the near future. It's an implantable lower Sophocles fingered neuro stimulator, placed the leads replaced during laparoscopic surgery against the lower esophageal center. The L. E s have stimulated at a frequency of 20 hertz, 220 milliseconds, five million amps, and it's delivered in 12 30 minute sessions daily. So it's kind of like taking the L. E s to the gym and having it lift some weights. And it's very interesting that over time this really seems toe work. This has been a very small cohort, about 18 patients, some initial studies done down in Brazil, but it has significantly improved esophageal acid exposure. Um, up to two years after the procedure. Quality of life scores is, you would anticipate of also improved significantly. And there have not been issues with bloating or disfavor with this device and also interesting. Interestingly, lower softball sphincter pressure improves by taking the L. E s to the Genoese. If you turn off the end of stem acid exposure goes back up. Didn't you turn it back on again? Acid exposure goes back Now. The current status of it is that it's CE that is European approved for implantation, and this year we will begin doing FDA approval studies. So it's something that is on the horizon, but I think has significant promise. Lastly, I'll just briefly mentioned the strata procedure. It's been around for a long time fans oral catheter that provides our aft ablation. Initially, it was postulated with fibrosis or sensory innovation, where the mechanism. But that's probably not the case. It does reduce transient El Es, relax ations, and it's shown at 10 years to be fairly successful. Objective data have been conflicting, and it has not been shown to normalize pH values in a number of patients, but it has reduced asset exposure. So how do we select patients for these anti reflux procedures? Well, to me, I think the first part is asking, What are we treating? Most of the time, we're gonna be looking at patients who have problems with medical therapy. Partial responders do as well is complete responders. Oftentimes, we we talked about non responders, and we're not clear whether we mean that they don't respond one iota two pp ice or whether they respond part way. And studies show that partial responders do as well as complete responders. If they don't respond at all, we need to document good and then carefully select those patients. Some patients don't wanna take acid suppressive medications at one of the things that I try to keep in mind is that regurgitation is the symptom that is best controlled by an anti reflux procedure and one that is poorly controlled by acid suppressive therapy. So troublesome symptoms decreased quality of life. We actually used these quality of life. He's good. Hr que els things in our practice to get a, uh, somewhat objectified sense of symptoms both on and off PP. I way actually have ah website where patients could go toe, take this quiz and we perform these questionnaires on and off acid suppressive medication. Preoperative lee. I'm a firm believer that before doing any of these procedures, we wanna have objective documentation of Kurt. We can do that by either looking at evidence of mucosal damage or excessive this official acid exposure. We also wanna look at US official function by motility and videos off program. And I like to look at the anatomy to know the size and type of the higher A hernia. When it comes to me. Coastal damage. We have esophagitis and we have barretts esophagus as evidence in the coastal damage. And for me, if a patient has l e C or d esophagitis or shorter, long segment barrettes that there's adequate documentation of reflection If they just have L. A B or a esophagitis or I am without visible C L. A. That's not to me, adequate documentation of reflux. So in the majority of patients we do ambulatory reflex testing. We do it. I'll mention off of assets, oppressive medication. We will sometimes do impedance testing, specifically looking at the number of reflux episodes and a patient on PBS. But we do it typically off assets. Oppressive medication is the majority of studies that have looked at the outcome of anti reflux procedures have done it. The patients tested off assets oppressive medication because our goal is to document that there is good GERD, Um and we want to see how patients feel off of their assets. Oppressive medication. We will do the impedance pH test on acid. Mr. Depressive medication of patients will not come off of it, and we also will combine them with a proximal ph sensor off of acid suppressor medication. If we're evaluating help, er, we look at the number of episodes. If we're looking just that impedes. I don't really look at symptom correlation because there really isn't much evidence in the surgical literature. That symptom correlation during a pH study is indicative of a good response or a poor response from an anti reflux procedure way. Look at Asafa Jill function, thinking about what the ability is to clear a Bullis and also how the E G. J functions, whether there's e. D. J awful obstruction, I look at this both by Asafa JAL Manama Tree and buy a video. Asafa Graham. So one of the things that I think important emphasizes that a patient that is a parasol that can has reflux can still be appropriate for an anti reflects procedure. And in fact, the cynical non for that is an ankle Asia patient who undergoes a hello. My Autumn E has wide open L. E s. After that, they are a parasol tick, and we do a partial funding application on those patients either an anterior or posterior fund application to help control the refunds. So a parasol sisters, not contra, indicate an anti reflux procedure that probably does contraindicated doing a complete mission 3 60 degree rap. There's also some evidence that multiple rapids follows is a way of looking at the potential for a good response. Even the setting of a complete fund application of patients who have poor Paracelsus multiple rapid swallows is what happens with the blood of inhibition. Patient takes multiple swallows, and what we look at is how much increase in the D. C. I there is in comparison to single swallows. There is a significant increase in the D. C and a patient who has significantly impaired Paracelsus. These patients seem tohave less to stage a after a Nissen funding application than if there is no improvement in the they're still contract. I'll integral during a multiple rapids follow. So how do we put this all together, especially in face of multi multiple procedures that could be done? Well, this is a patient centric approach. The patient driven decision. I looked at the seriousness of the disease, the degree to which the current status affect the quality of life response to anti secretary medication, their willingness to use some anti secret Torrey medication after the procedure. Willingness to accept side effects vs reflects control. Yeah, visceral sensitivity we know is a part of all of this. There are also disease specific concerns. Some patients may have a complication of GERD or hyo hernia, regardless of their symptoms such as asthma, interstitial lung disease, carassava, hernia with incarceration or progression of the inflation, I looked at high. It'll hernia size and how that effects e g j function. I look Asafa, Jill, Paris, Tharcisse and Millie s characteristics and also how much reflex is going on. And if we were to plot reflux control versus side effects. Some procedures, like a complete funding application or a partial funding application, have pretty good control of reflux. But they do have their side effect. We have the strata procedure, which has maybe 40% reflects control, but essentially no side effects. We have the tip procedure which objectively has better control of reflux symptoms. Still no side effects and the muse I put down low because we don't really have any multi center studies on that. And then we have the links. And I think if I for my point of view, the links is probably currently the best that we have. In terms of combining reflects control with few side effects. The side effects from the lengths were primarily this fija. As I said, we're learning better how to manage that. If you add in the third act access to all this and in this case, the access that I'll add in is your ability. Then things fall out a little differently. We could change this access to be esophageal body, Paracelsus or other factors. So it's not just a two axis thing. It's a multifactorial thought process that we go through, but these third access factors or durability. To me, the links is maybe better than or at least equal to a complete fundo application, which is better than a partial, which is better than a strata, which is better than a tiff better than a muse, this motility strata no issues tiff like a partial. Some issues complete funding applications can be an issue. Links is probably the one where we're most concerned about having enough Paris topic force in the fullest movement toe, open up The magnets, hernia, tiff, muse and strata are limited to patients who really don't have a significant hernia, probably less than two centimeters. So I use one centimeter. Is my maximum limit for a tiff procedure sort of summarize? I think there is a need for new interventions to treat GERD that's increasingly evident to the G I community as well as I think, primary care providers, interventional procedures address the lower esophageal sphincter, pressure length angle, whoopee cushion characteristics as well as the diaphragmatic components of the EEG J function. Can I think these new interventions have a capacity not only to replace this in front of application and the majority of patients who currently having this, but they will likely improve the quality of life of patients with GERD, who previously would not have considered an anti reflux procedure because of perceived invasiveness for side effects. So I think we can start toe close that therapy gap with these new interventions. Uh, thanks for your time and and for your attention. Uh, that's my email in our office number. I'm delighted if you want to contact me about things down the road and I think we may have some time for some questions. Thank you, Dr Bell, for that comprehensive presentation. Wendy, I believe you have some questions from the audience. Could you give Dr Bell the first question? Yes, I believe this one was partially answered. A few slides back, but it is. What are the best candidates for tiff procedure or sa fix instead of laproscopic fund application. Does the higher does the hernia size play a role for preferred procedures? Yeah, that's a that's a good question. So when the tip was initially studied, it was hernias, two centimeters or less. And when we analyzed our data from this multi center study, we found that the success rate was less in patients who had a two centimeter hernia than no hernia or a one centimeter hernia during a tip procedure. The most you can do is hope to capture the free no Asafa Jal membrane in the fication. And so if the hiatus is too wide, it's just gonna pull that capture apart. And if the hernia is to talk, there's going to be too much movement back and forth. So for me, a limitation of a theft is that it really needs to be done in patients with very early stage disease. By early stage, I mean very little mechanical disruption of the hiatus. I don't really advocate doing it. In addition to ah Heidel hernia repair. I guess my feeling is if a surgeon is going to go in with a laparoscope and do a Heidel hernia repair. They probably ought to just do a funding application. A partial funding application of that same time. It just seems to me to make the most sense. Thank you. Wendy. Do you have another question? Yes. Ah, we know that there is a neural reflects between the proximal and distal esophagus. When we create a mechanical resistance at the E g J. Will this distal resistance induced inhibition on the proximal esophageal motility inducing dysplasia? You know, that's Ah, that's a very good question. And I would say that when we've looked at video Asafa Grams on patients with the links procedure, which is probably the one that creates the most innate resistance at the initiation of a swallow. Um, those video soft grams have not shown dilation of the esophagus eso There are two parts of the question. One is Will it initiate this fija? We don't really know why this page occurs. I've done. I've been in on Sydney Asafa Grams when patients complain of this page and there's no connection with when the fullest goes through or doesn't go through. So how we sense this fija Beyonce and say, I don't have a good sense off. But in terms of leading to dilation of the esophagus over time and and leading to, uh, disordered Paracelsus, we don't know fully with the links. Patients were out 10 years now over in Europe without reports of significant this page issues or a Paracelsus or decrease Paracelsus. But we really haven't studied it, and I think that's something that does need to be studied. Thank you, Wendy. Do you have another question? Yes. If the patient has non acid or weak acid reflux, what would be the therapeutic option? A surgeon? Well, to me, weak acid reflex or non acid reflux is simply reflects events that are typically seeing where the patient on PPS eso To me, there's not really a difference in whether they have acid, non acid or weekly acid reflux. The goal of an anti reflux procedure is to stop gastric juice and whatever type coming back up into the esophagus. So whether it's asset, not acid weekly acid to me is not terribly important. We usedto maybe think that if we study the patient on PP ice and they had non acid reflux, which simply meant acid suppressed reflects events that that was a good indication for doing an anti reef watch procedure and I would agree with that. Some patients have a significant number of non acid reflects events, Father on PP ice. They're symptomatic in relation to typical GERD symptoms. That's a good indication. I still oftentimes will take those patients off of PPS and see exactly how much acid exposure there is during a 24 our period or longer. Just to give good, objective documentation that there is acid exposure, sometimes with P. P I. Sometimes there is a slight decrease in the amount of gastric fluid because gastric acid secretion has decreased. And I found also that there are patients who clearly have reflux that have normal 24 hour tests. And so, if I have a patient that I think has reflux, they have a normal 24 hour test. I will do more prolonged monitoring on that patient most of the time that involves using a telemetry capsule pH system 48 or 96 hours. So look at what kind of data day variation we get. Very good windy. Next question, please. Yes. What is the data on Asafa Asafa Jill Jill, It ation of patients who have had of links. Is there a maximum diameter Dilip ation that should not be used? And let's see if there was more to that question. I think that was it for that particular question. You know, we really have Most patients that have had a links have had fairly normal esophageal body diameter because most of them have had fairly normal Asafa jewel body prosthesis. So our threshold for doing a lynx is that the distal esophageal amplitude, uh, measured three and seven centimeters above the L ES toe averaged out needs to be greater than 35 millimeters of mercury pressure, which is roughly equivalent to a D. C. I of about 400. So those patients rarely have esophageal dilation. As I mentioned, there have not been a lot of studies looking at five and 10 year outcomes in terms of whether esophageal dilation has happened after that. But certainly a patient who has week parastatal assis, I currently don't think about doing the links on because I know the mechanism of action is that one has to be able to generate a parasol tick ball, intra bolas pressure of greater than 25 millimeters of mercury toe. Open up the magnets. Okay, Very good. Windy. Next question. What is your procedure of choice for those who have a four plus centimeter hide a hernia? And why? And does the choice change if it's greater than seven centimeters? Uh, that's a good question. You know, the, uh, I think it really depends not so much on the size of the hernia, but upon how bad the reflexes, what kinds of symptoms we're treating. If patients have Barrett's esophagus, L A, C or D esophagitis. If they're having aspiration pneumonias, which we commonly see in these bigger hernias, then I tend to favor a missin or a partial funding application. If I can't do innocents for whatever reason, in those patients, if a patient has just typical reflects symptoms, uh, that I have increasingly looking at the links procedure because I think it controls the reflects symptom eyes as well as a missing. And I don't we're doing a carefully controlled registry outcome study on this, so I'm not advocating it for everyone. But the initial results of doing the links on these patients with bigger Heidel hernias has overall been very promised. The major issue with these big Heidel hernia is when you get up. The 6 to 7 centimeters is that you really need to do extensive dissection in the media Simon to free up all the scar tissue around the esophagus to get it down into the abdomen. And that, to me, is probably the most important aspect of doing a high level Ernie repair in any of these patients. Whether you put a nissen or links or a partial funding application on after that is probably less of ah issue than doing the dissection on the repair properly. Very good windy. We have time to more questions. All right, maybe we can sneak in three. Here's a quick one. Is links available in Europe? You know, that's what I have to say that I did not currently aware that it is ce approved, but I I can't answer that definitively. It's been the very first studies were you were done in Europe and I'm not completely sure of its status in terms of CE approval. Okay. Thank you. Next question. Do you undertake us off that your function in all patients? What about neurologically challenged individuals? Okay. Yeah, We've had a couple of patients who you know clearly you're not gonna be able to tolerate a motility study. Even with sedation, I will, uh, give patients Valium in the office, or sometimes place the cap that air during a sedated and Bosc api. Uh, if I know that they're going thio not they're gonna have a bad gag, reflects and not tolerate motility study from that point of view in the patients that we cannot even do that on, then I will get a video Asafa Graham and we have a protocol whereby patients take half a bagel soaked and barium and swallow it with their head 15 degrees in trend Ellenberger. And if that's if that Boulis is cleared within two swallows, that seems to correlate very well with normal esophageal motility. So that's another way that we try to get a things. If you don't have that protocol, give them some crackers and look at the video images to see how well things clear. So, to me, motility is the gold standard, and it's the most precise. But I try to complemented with this other imaging modality. Aziz. Well, we have several minutes left windy. If you could pose the final question, please. Okay, let's see. I'm trying to find a good one. Here. There. There's a few. Let's see. Just a moment, please. Okay, there's a question about doing post, uh, doing reduce. When do you perform redo operations after Nissen. Okay, so when do we do reduce After innocents? Most failures of anus and are due to failure of the Heidel hernia repair? And what happens is the fund ist of the stomach that is, the fund obligation starts to herniated up beside the esophagus. It can cause this fada and chest pain by being pinched by a small hiatus. Or it can lead eventually to just pulling a part of the funding application leading to recurrent reflux. If it's paying this fija and there's this herniated fund application, that's a mechanical issue that I think needs to be best addressed by re operation. If it is simply recurrent reflux by loosening of a fund, a publication and I either don't see a Paris softshell hernia or I don't think it's terribly worrisome, then I'll try to manage those patients medically with the recognition that a re operation has higher risks and lower outcomes ban a primary operation that said, We do probably 50 re operations a year. We accomplished 99% of them. Microscopically, our overall complication rate is very low, but it's a procedure that takes me twice to three times as long as a primary mission. And if I can manage a patient adequately with medical therapy that I'll do that, thank you, Dr Bell, we have consumed all of our time. I would like to thank the participants for the excellent questions that you posed, and anyone that would like to listen to a recording of this webinar. You will receive a follow up email within 24 hours, providing the connection linked to the recording. Please share that email with your colleague's so that they, too, can benefit from the event. Thank you, Dr Bell, and thank you participants.
