Gastric Neurostimulators: Update Course 2017

So, uh, so, OK, so we're gonna talk today about something that we have been doing for what, uh, 10, 9 years maybe thought that yeah, and, and, and it's something that is really exciting for us, you know, uh, sometimes being patient. Kind of a gastric symptoms that they don't get better with conventional treatment, how some new technology could help them, you know, so this has been a, a passion that we have in the last, in the last few years, um, uh, I wanna start with a case. It's a really easy case. Don't worry, it's not as complicated as the one that we saw from, from the cardiologist, OK? So this is a 17 year old male that is coming with a weird unusual autoimmune condition that affects all the glands, and, and they can present with the multiple endocrinopathies. And this patient came with an initial complaint of uh epigastric pain, heartburn, nausea. He was feeling full really early in the meals and also he was having some vomiting and regurgitation. He has a totally normal blood work. He didn't have any pancreatitis, normal celiac testing, and normal, uh, uh, thyroid function. Uh, of course, we did an upper endoscopy with biopsies that were completely normal and also we did an upper GI that was completely normal. So this is uh this is my first question for you guys. uh uh what should be the next step in the investigation of this patient with dyspepsia? What, what would you do if it was your patient, you know, knowing that this patient has been suffering for for a chronic time with uh with these uh symptoms and with a normal endoscopy and normal initial investigation, a normal upper GI too. I think they need a fun though. So I, I, I was looking to see if uh who's here. So, uh, is Rothenberg gone? Did he he's over there. Oh, here he is. Well, actually this is actually a great question. So, so you say what would you be the next, you were joking, but what would you, what would be your next would you do any test in this patient that is coming with dyspepsia and you have a normal endoscopy, a normal upper GI. I probably would, would not be smart enough to do anything. So, so that's. So we have an, we have an abdominal ultrasound, right upper guardian ultrasound. Maybe not the best test to do this because the patient is having, not having any right upper guard and pain and not having any biliary symptoms. Would you do, would you do a small bowel follow through? I don't think that that would be my first choice. No, patient doesn't have any signs of a small intestinal obstruction or so. Uh, any room for an abdominal CAT scan, uh, you know, it doesn't seem to be maybe the best case for that. So some people would do esophageal pH impedance. Uh, 44% would do that. esophageal pH impedance. That's a, that's a good, that's I'm surprised by that, you know, but that's a, that's a, that's a good answer. Uh, PH impedance is a, is a, is a really new technology to, to look at the acid and non-acid reflux, and that could help in the patient. But remember that this patient did not have any esophagitis. Endoscopy was completely normal. Endoscopy was completely normal, but that's a good test. Steve. So was there a biopsy correlation. I mean you have normal, normal endoscopy, but you might have a very high correlation on, on reflux events and symptoms. That's, that's very good. What were you gonna say something? No, I was gonna say endos. Endoscopy is not very sensitive. Endoscopy and biopsy is very sensitive. So if biopsies were performed, I'd were normal, yeah, so biopsies were performed. Do you always perform them? We always do esophageal biopsies, yeah, OK, OK, and they were, they were fine. Uh, and what about gastric emptiness scan? What percent of the people would do a gastric emptiness? 46%. 0, so that's because they know a gastric gastric stimulation. I would rule out biliary dyskinesia. My favorite, yeah, it is your favorite. I was this close to put skin. Yeah, you need a. So, so, so this is a good thing, you know. I forgot to tell you that this, the, the heartburn got better with the PPIs. And the main symptom continued to be at this time the nausea, the vomiting, and the, and the regurgitation of the patient, you know. So of course we did a gastric emptying scan, and, and the gastric emptying scan was abnormal. It showed that, uh, uh, uh, uh, 2 hours, still 90% of the food was in the stomach. It was a solid phase gastric emptying scan, uh, and, and that's, that's really abnormal just in case that you don't know, that's really, really abnormal. This patient has a severe gastroparesis. So we, we did the conventional treatment. What is the conventional treatment? You do a lifestyle modification. You tell the patient to eat a small meals frequently, no fat, no spicy food. Uh, we, of course we use, uh, multiple nausea medications, PPIs, uh, and we try prokinetics. Uh, unfortunately we don't have that many prokinetics here in the USA and then we use, uh, erythromycin and as maybe the, uh, the only one in this patient. They didn't want to use Reglan because of the potential, uh, possible side effects, uh, uh, and, and. And the patient, uh, continued with symptoms. The heartburn got better, but the, the nausea and the dyspepsia-like symptoms continued. So what is, uh, what would be your next step in this patient? What would you do next? Would you talk with the family about trying a different prokinetic agent like a cisapride domperidone, uh, the Reglan, metoclopramide? Would you do a Botox injection? On the pilot. Will you do a fundal application even that the patient is not having any more heartburn, have a normal endoscopy and normal biopsies. Will you do a pallidoplasty to help with the emptying of the stomach? Will you try your renal feedings, nasojunal or gastroodrenal feedings in this patient, or would you try something that is called a gastric stimulation that maybe you're not aware of, Steve. I would get a Haider skin. No, I'm serious. I would get a height of skin. I would like because I think that these two disease processes are interconnected, and I think you need to, I mean, it depends on whether you believe in the diagnosis of biliary dyskinesia. I happen to believe in it, so I would want to know that this patient has negative height of skin, negative, negative. So if they, then I would, by the way, we do do that in everybody. We do a lot. OK, so we do a lot of. What do you want, what do you want to do, Steve? So if, if, if this patient's, I mean, you know, we have special trials for scisapride, but most people can't get on it or don't want to try it. If, if it was available, I would give a trial of it just to see if they improve on that. Apparently the company is, is being really difficult to approve, so you would try to do scisapride. We're trying 3 patients that. Even though we have an IRB approval, we, we have not been able to get enrolled in patients, so it's, it's not a good option, but it would be, so it's really difficult to get, I think now we would try, you know, if, if they're really debilitated by their nausea, if it's affecting their lifestyle and they're at the point where they really want to do something about it, we would try temporary gastric pacing, so I wouldn't. I would try jujunal feeding first to make sure that that that actually fixes the problem. That's a that's a really good option, you know, your renal feeding for two reasons. One reason, one reason is that you wanna be sure that there is no small intestinal, and you wanna make sure that the patient tolerates your general feeding. And the other because, uh, it may get better with time, the gastroparesis, and, and maybe you don't need to do anything more aggressive, but you know that there is not really data that prove that your renal feeding is an option. It's a good option for patients with gastroparesis, but why we review the adult data and the limited pediatric data, you know, there is no significant evidence that this is a good long term solution for families. Jujunal feeding is a terrible thing. It is, I think it's a diagnosis. It's not an answer, right? But if you do, you can, you can do duojunal feeding and say, OK, they're better, but what about the patient who you do gastric pacing on. And that improves their symptoms or the patient that you give jujunal feedings and that bypasses your stomach and improves their symptoms. How are you going to treat that patient? So your point is that you think a temporary gastric stem is a better, is a more efficient test to getting at what you're going to do than if the goal is to get rid of the patient's nausea and allow them to eat normal life, normal life, then what is going to give them more of a normal life? Is it gonna be. And assuming that both of them get rid of their symptoms. So you gastric pace them or you put it in a jejunal feeding tube. I mean, to me the nal feeding tubes, to me the jejunal feeding is not a long term solution, but if you do jejunal feedings and their symptoms don't go away, you're probably not going to help them with gastric pacing, right? But if you do so, if you do temporary gastric pacing, which is a, is, is. You know, is a non, I mean, I'm not talking about putting laparoscopically putting in a permanent pacer. I'm talking about temporary, temporarily pacing them, so it's an endoscopy. It's like doing a pH probe. So if you do a temporary pacer and you improve their symptoms or you do a juvenal feeding tube and you improve their symptoms. If you ask the parents or you ask me which road is better to take, I would go for gastric pacing before I'd commit them to 3 months of, even if it's temporary, 3 months of jujunal feedings, because I, I don't know about you guys, but jujunal feedings are a huge management pain in the butt. It's either a. An NJ feeding tube, which constantly is coming out, or you do a surgical J tube, which is a huge problem. All right, so just for the sake of moving on, I also want to make one point. It's not gastric pacing, gastric stent, and the reason, the difference there is that this is not pacing a normal rate. This is actually stimulating. We're using a low, low, low, low voltage, um, and, and then I also want everyone to keep in mind, uh, Wit and Steve, Dan, I, I, I. And Dave, I I wanna know when what's tough with these patients is when to do a fundo and uh this patient sounds like they're mostly nausea, but in patients that are having uh how do you know it's it's not just reflux that could be treated? A lot of the patients that come see me for gastric stem, I end up doing a fundo on them. Um, well, that's why you get a pH you get an impedance broke. So the question is, A, do they all get pH impedance first, and B, how much do you trust your pH impedance. And if your pH impedance was normal, then you would go to gastric stem and if it was abnormal you would do a fundo. So I just, I, I don't have the answer. I don't wanna go into that whole thing now, but I will say that in, in centers that start doing a lot of gastric stem there's a crossover of figuring out who, who would benefit first from a fundo versus a gastric stem, and I'd rather do a fundo before a gastric stem. Because it's hard to go to an, uh, a Nissan after you have a gastric stimulator. Uh, it's, it's, you're working around it and the stomach is stuck up to the abdominal wall. So anyway, you have, so if you do that and you know that the patient has gastroparesis, do you do a gastric emptying procedure at the same time you I do not because most time, most of the time when you do a fundo, that's adequate to relieve their gastroparesis. So their their delayed gastric emptying is improved. Almost always when you do a nasinolone, so I, well, there, there, there is some data that, you know, suggests that maybe pediatric patients with a neurodevelopmental problems, you know, the, the. The, the gastroparesis may be the reason for the gas bloating syndrome, you know, uh, not the, not the Nissan per se is a baseline, the stomach was nonfunctional, but if, but we found, so we found though if you do a Nissan. What they present with after you're Nissan is wretching. So if, if, if the gastroparesis did not improve, right, so our algorithm is if they, if you can't tell, do the Nissan, if they get better you're done, if they wretch, then you stimulate them and we've found that gastric stem shuts off post- Nissan wretching. Wow, that's great. Well, that's a. That's new information. Would you say that that's probably our most exciting, our most exciting outcome that would relieve a lot of misery after. That's been the biggest break. But if you're doing a Nissan for nausea, you're doing the wrong operation, for nausea. Well, that's, but that's the difference. You're, you're, you're saying I would do a Nissan. Yes, absolutely, if they have reflux or they're chronic vomiters, and then you have to decide why are they chronic vomiters. And sometimes when you do a. You do a Nissan and a chronic vomiter, all you do is create a chronic wretcher. There are patients who have hyperemesis who you can fix with a Nissan. Great, great. And that that's the, that's the change point. So that's what you have to figure out. But if they just have, if they just have nausea, then a Nissan isn't going to help. I don't think anyone would do a Nissan for nausea. Well, but you, but you have to be careful. So it's chronic vomiting. It's hyperemesis, and is a Nissan the right operation for that or not? And the probably the argument is, is that not necessarily, but it's, it, I agree with you, it's a, it's a tough decision point. But what you, I have a couple of patients who, you know, they, we did PH, they reflux, but they were really mostly they were chronic emesis, and we did a fundoplication, and then they're chronic wretchers. Yeah, all right, sorry, Ronaldo. Yeah, the only thing to add, obviously with our expanding experience for a clays with per oral myotomies, we're now in the adult population, we're doing per oral. pyloroplasties, which actually has changed our management for gastroparesis. We now just can do it endoscopically, which changes a little bit. I'm not sure if you're doing that in pediatrics or not, but we're not. Um, Tim Kaine is, uh, there's a guy in Children's National who attempted to do his first, and they, they, there was so much inflammation from all the Botox injections that. They couldn't find the plane, but I know that, uh, I, I don't, I know that my father says he's done like I think 75 or 80 per oral palloryotomies, and he says they work great, so that's something I saw a video. I can do one. I get. OK, so, OK, sorry, uh, uh, so, so we went for the gastric stimulation. So we do, we do, we place a temp gastric stimulation and, and, and after 3 months we, we, after 3 months of no improvement of the symptoms with the conventional treatment, we went for the temp gastric stimulation. Uh, patient did really well. All the symptoms went away. Uh, uh, we, we were able to stop all the nausea medications and we only continued with the PPI. To prevent the current, the recurrent heartburn, and after 20 days with the temporal gastric stimulation, we decided to move forward with the permanent gastric stimulation. That was 2 years ago. The patient continued doing really well. Currently he's asymptomatic and he's and the only medication that he takes is a PPI. Ronaldo, uh, Witt wanted to point out that in the poll to the virtual audience there was a lot of answers. There was only one choice that no one would do, and that was gastric stimulation. Hopefully, hopefully this is gonna change. OK, this is a good that was uh. Well, well, I must admit before we started doing this I thought it was voodoo. Yeah, I mean it's it's difficult to get the concept of why, uh, this, uh, I still don't understand, but, but we're gonna try to explain that we're gonna try to explain that if we have time today, uh, if not next year we will, we will continue with the topic. So this is the equipment, this is how it looks like this is the gas leakage stimulator, uh, come from different companies uh you can, you can approach the company that you like to use it uh we're not gonna talk about that today um. And basically what happened is in the stomach you have a pacemaker. That is, uh, this pacemaker is made by the cells of cajal, uh, uh, so this pacemaker, uh, is the one that is gonna coordinate the electrical activity of the, of your stomach exactly like the heart with the difference that is a low voltage electrical activity. It's no more than 60 millivolts. We're talking about tons of tons between 20 to 40 millivolts that is gonna constantly. Every 20 seconds, 3 times a minute, it's going to radiate in the stomach. How it's gonna get this electrical conduction is going to be propagated through the my enteric plexus, you know, the Ava and Meisner plexus that goes in the stomach. Basically they're gonna propagate in the uh uh proximal to detail and also circumferential way the electrical activity of the stomach. One thing that I have to remember you that this electrical activity is not gonna pro it's not gonna initiate contraction of the stomach, but it's gonna set the pace. So any patient that has 3 waves per minute cannot have more than 3 contractions per minute. If a patient has only 2 waves per minute, it's not gonna have more than 2 contractions. And if the patient has a disorganized contraction. It's not gonna maybe affect the stomach in a way that is not gonna be any way that the stomach uh will be ready to have a contraction. Basically this electrical activity that is coming from the Selo Cajal is gonna. It's gonna repolarize the membrane and it's gonna keep the adequate polarization and electrical charge that you need to when you have a stimulation have a contraction. So if you don't have this uh set up ready, there is no way that the stomach is gonna develop a contraction. That's why. You know this equipment works in a different way. We are not going to stimulate the stomach to a way that we're going to pace the stomach. What we're gonna do is we're gonna do low voltage that is going to go to the stomach. It's gonna propagate and stimulate the cell of coals, and it's gonna try the stomach to come back with a normal again cycle. So the stomach has a dysrhythmia just like a heart can have a dysrhythmia, and this shocks it into a normal rhythm. So I will be careful with the word shock because we're using only maximum that we use is 7 volts. How many volts do you use for the, for the, for the diaphragmatic 25 mills. So it's imagine that we use no more than 10 mills, no more than 10 mills. Uh, so this is a totally, totally different. So this is a low voltage, really frequent. Electrical signal that we're sending and most of the time this pacer is off, uh, so it's only on maybe 0.1 seconds every 5 seconds and that way we try to reorganize this electrical conductivity in the stomach. So how can we, yes, sorry, that's about the shocking because one of the complications we've had is we've had two patients who feel shocks that we've had to read on your on your temp, no permanent, so it could happen, uh, basically if you take a, I'm gonna, I'm gonna give you this example if you buy a battery, uh. That is a 9 volt batteries. You have two electrodes in the top. That's 9 volts you put in your tongue. What are you gonna feel? You could feel, but you're you're gonna feel that more. You feel, you feel it. There is some electrical conduction there. This is more or less when you feel when you get a, a, a gastric stimulation. That's more or less what you're gonna feel because we don't use more than 7 volts. Yeah, but most people don't ever feel anything. It's not like you get used to. They get, they, they feel it, especially when you make a big change, but they get used after one day or two of the sensation of something in the stomach. I, I, I, I tell them that it's like a butterflies in the stomach, so that they're feeling in love or something like that. So, uh, sometimes the pain can be from the anode returning electrodes. So depending on your because on the, the. The IPG, the implantable pulse generator, is your anode. And so if the anode's close to the dermis, they can feel the return current. So, we have that in, in patients, we implant an anode. And so if it's, especially in children, you don't have much subcutaneous fat, it can affect that. If you're close to the dermis, they'll feel that. So that's why you want. Your pocket, as you know, so I think the dermis, I think what I always had thought had happened from because we saw it in our attempts is in patients who have a G tube because you've taken the stomach which has fistulized up to the to the muscle in the skin, so it transmits the transmits is actually it feels that it's very interesting, especially when you put the lights in children, you don't have as much subcutaneous fat. Have you seen that I don't know, it's been, no, it's these two patients didn't have G tubes. They were, it was later. It was not after we put it in. It was months later. Um, one case was secondary to some abdominal trauma, but I ended up having to replace the pacing wires, and it went away. So yeah, uh, what about the impedance? Impedance was normal in these cases. Wow, surprised about that. So we'll keep going because we're running about 20 minutes behind. So, so basically most of the centers, they, they, they just go to the permanent, uh, gastric stimulation. And, and we think that there is a 30% of the patients that maybe this permanent gastric stimulation is not gonna work. So the question here is that there is any way that we can predict who's gonna be the patient that is gonna respond, respond well to the stimulation, and that's basically what we did in this patient. We did a temporary stimulation first, um, in this case because the patient did not have any, uh, G tube, we put it through the nose, and that's one of the ways. We use a cardiac uh leads that will go through the nose. They attach to the stomach, then we clip it with any endo clips that you can that you can have in your lab. Uh, uh, they're going to stay in contact with the mucosa. It doesn't need to be all the time in contact with the mucosa, uh, at least that's what we think, and that's gonna help us to stimulate. If the patient has a G tube, uh, uh, you can use. A different type of wires you can, uh, uh, the one that you can that we use are the ones that the, the fetal scalps and, and we pass through the G tube side and, and then we attach it to the stimulator that you saw in the pictures. What kind of parameters do we use in the stimulators? As you can see, this is totally different than the ones that the stimulation that we were talking about before. This is the frequency of the stimulation. It's gonna be 1414. Cycles per second or sometimes we can go up to 55, but it's going to be on only a few seconds and as you can see it's going to receive only 12 or 3 shots of small electricity and then it's going to be off, then on again. So basically the patient receives really few shocks of small voltage, low amp, low millamps on the stimulations. Usually we don't do more than 10. Milliams as you can see here and usually, usually, usually we keep the equipment uh uh uh no more than 3 seconds on and 2 seconds off and we don't do more than 110 cycles per minute uh so, so, uh, how, how is that getting planted? How, what is the permanent uh placement of the of the of the equipment? I'm gonna let Doctor Ponsky to explain that to us because he's the expert, uh, uh, uh, implanting the equipment and the expert, yeah. Uh, so we're going to actually skip this part because we don't, we're running really far behind, but essentially it's a lap, I do, you can do it open or laparoscopic. This is a lot of these slides were from Fred Brody and George Washington, who taught me how to do this about uh. Uh, 2003, so a long time ago, 14 years ago, um, he, uh, these are his pictures. Basically it's laparoscopic. You put the wires in, we go really fast. You pull the wires in, you clip them in, you tie them in. That's there you go. That's the tuck, and then you implant the generator under the skin and uh. Uh, the rest I'll turn back over to Ronaldo. OK, so, so, and that's, and that worked really well. So, uh, 5 minute procedure. So, it looks longer when you are there, but yeah, it's only a 5 minute procedure. Uh, so, uh, let's go to the case number 2. So this is a. We're talking about at the beginning. This is a totally different case. This is a patient that is only 6 years old. He has a history of cerebral palsy. He has a significant neurodevelopmental delay or some moderate neurodevemental delay, and he has a previous Nissen fund application that was done to treat the reflux symptoms. And the patient developed what we call gas bloating or reaching syndrome after the fundal implication. And we tried multiple things. Uh, the patient had a GEJ tube. The patient was on PPIs. We tried prokinetics, uh, even, even metoclopramide, despite that the patient have a history of previous seizures and and and abnormal movements. Uh, no improvement of the symptoms with the conventional therapy, with the change in the feeding. The patient continued with severe gagging and wretching. Uh, he has an upper GI that showed that the nixon was intact. Uh, we did an upper endoscopy with biopsies that were completely normal, no evidence of esophagitis, gastric ulcers, and no any, uh, eosinophilic gastrointestinal condition to explain symptoms. Uh, and then that's the next, uh, question that I have for you guys, uh. Uh, what would be the next step? We use a totally different prokinetic agent even though you know that most likely the response is going to be as most moderate? Would you do Botox injectjection in a patient after an easy informed application that is having gas bloating syndrome? Would you do a pyloroplasty? Would you try geojunal feedings, or would you go to a gastric stimulation? Almost. That's a great question. Post-Nissan wretching, Steve, I know you think it means the Nissan was done wrong, right? No, no, I think there are certain patients that wretch after a Nissan. I think if your Nissan is intact and so generally what, what would make me go the next step, some patients just wretch. And what you have to find out before you do the Nissan is did the patient, does the patient wretch, and the answer is usually yes, it's just they're vomiting. So, but if the patient vomits or wretches a lot before his Nissan, the likelihood, especially a neurologically impaired kid, is that they're gonna, they're going to gag and wretch afterwards. Our, so basically if they break down their wrap, so if they gag and wretch enough to break down the wrap, usually the next step is at that point I would, I would have evaluated their gastric emptying and I probably would have redone the Nissan and considered doing a pyloroplasty if I saw a significant delayed gastric emptying to try and change the dynamics of what I was doing. I don't see a lot of these types of patients, but based on what I've learned, I would be tempted to redo the Nissan and put in a gastric pacer, assuming that he improved with gastric a gastric stimulator, sorry. Assuming that I would do a trial and see if the kid improved with the stimulation, and this is a great patient because there is no placebo effect, uh, like in other patients. David, yeah, I'd be interested to see if you see improvement in the symptoms if you put the G tube to gravity drainage or do GJ feeds. Absolutely, yes, that's, that's part of the conventional treatment, GJ with gravity of the G port that. It could help, but you know, uh, venting of the venting of the stomach, not always get help with the gas bloating, not always help because maybe the defect is the accommodation more than the than the anything, you know, sometimes, um, I'm just curious though, was, would anyone here else do gastric stem for this patient? Um, now that you've seen that this works, let's see with the poll, 73%, yeah, 73% say gastric stem, so you've, you've switched from 0 to 73%. You are so convincing this time we did it well. Time to buy stock. Um, yeah, I have to tell you this has been our favorite, um, result with this is it in the post Nissan retros if you're sure the Nissan's OK, uh, we've, we've been impressed. So we, we, we did the fetal scalp gastric stimulation. We only needed 10 days. The patient was doing great. No more, uh, wretching, gagging. Uh, he was a daily symptom in this patient, even when he was not getting feeding. He was completely asymptomatic. Uh, uh, after 3 years he has been doing great. No more symptoms. Uh, he's not using, uh, PPIs or prokinetics. He's not on any medications, and he's eating by mouth and using YouTube supplementation. Is this, is this just without saying names, is this the one I did first of one of the, OK, so that's that's not the last one. That's one, That we did that 3 years ago, 3 years ago, uh, and because that patient, just so everyone understands, that patient was neurologically impaired, so there was no secondary, no placebo effect, placebo crazy. The kid, the mom said he just wretched all the time and he had a, uh, we did a gastric stem and she came into my office crying because she said. He has never wretched since. So let me ask you this question given, given this scenario that is they've had a fundo and they're having wretching. Uh, who is not a candidate for this, we think that pretty much anyone is a candidate for a temporary test. There's no downside. It's like doing an upper G it's doing an upper endoscopy and clipping the, is that a two week thing or we did 2 weeks, 3 weeks, yeah. Do they require being in the hospital? No, no, no, no, no, it's an outpatient. It's an outpatient test. Uh, the, the only thing that maybe, uh, we don't have any data to prove that patients that tolerate. This type of patients with uh neurodevelopmental problems that they tolerate the general feedings, they do better with gastric stimulation. So if they tolerate the adrenal feedings, can you do both at the same time? Oh, you can do both, yeah, you can do. We try not to feed jejunally and also be doing the gastric. We, we, you can do it if you want. We try not to. We try to place a G tube at the moment that to truly test it, to truly test. We think that they should be off jejunal feed. So what we say is we take out the jejunal feed, put in a G tube, and say if this works you. Should be fine then and that's how our test because if we do the sometimes we have done it sometimes, uh, depending on what you, what are, what are your expectations, you know, if you, if you, if you wanna do this and and be 100% off the junal feeding, not wretching, we have to be with the G tube. I wanna, if you're OK doing the junal feeding, but you don't wanna see wretching, we try, we can try with the jejunal, the GJ tube on. Just how long do you, how long is the trial? How long do you give it? Does it happen immediately for some patients? Some patients take a little bit longer. There was a study done by Tom Abel, who is now in Louisville, and he took 22 groups of patients, um, uh, they, he, he had, he put them in and they were blinded prospectively whether the stimulator, the temporary stimulator was on or off. And on day one. Everyone did better. 100% of the people did better. And then on day 3, The group that was off did worse and the group that was on stayed well. So what he says is there's a 2 to 3 day placebo effect, so you've got to keep them on for more than a couple of days. So by day 3 it totally split and the offers were down here and the ones we were on did well. Then he crossed them over and it totally switched. It's the most impressive chart. So there's about a 2 to 3 day placebo effect that everyone says they feel better, so they feel better immediately after. But I mean maybe that's also just sticking the electrodes in the stomach. Maybe that does something. No, I don't know. They, they say they feel better, it shocks. We try not to see them the 1st 3 days because we know that they do you have any thoughts about all this that we haven't talked about any because I know you do a lot over there in Denver, so. No, I, you know, I think they're a difficult group of patients, and you know we have a couple failures where we temper, so we don't do a permanent pacer in anybody who we haven't had a positive result with a temporary stimulation. So that's, that's one thing. If they don't respond to temporary stimulation, we don't, we don't do it. So every, as opposed, I think to some of the adult series, everybody gets temporary stimulation. And then um we put them in and and we some patients have an initial response but then it kind of wanes and I think there are multiple issues involved with these patients. Some of them honestly are psychosocial, some of them are, you know, other issues going on, but we, we. You know, we have a couple of failure long term failures who initially seemed to respond and then didn't do anything. I think you need to rule out things like biliary dyskinesia and all those other things that are going in, but they're, I mean, my favorite story is I have a patient I put a gastric stimulator in. Got better. He lives on a ranch up in Wyoming, was in the barn, which was a metal shed. Got hit by lightning. It fried his pacer and his symptoms came back the next day. And you can make a movie and is he neurologically impaired? No, he was out. He was out there. No, but he, I mean, it was, it was, you know, he did, he got, you know, that's a great point, and he, and so we put a new stimulator in, and it, so there, there definitely is patients can tell when their batteries, but it start getting symptoms, it's a complex problem and it's not, um, and even if you get good results initially, it doesn't mean that they persist. Here's your data, Steve. Yeah, this is uh this is from, from Colorado, from Denver, uh, and then you can see that after 1 month, 3 months, uh, patients, uh, have a significant improvement overall, uh, symptoms, you know, not only the frequency, also in the severity of the symptoms. We all know that their symptoms are getting better, but we don't know why. I think most of us believe it's the vagal, it's like a vagal nerve stimulator. It's affecting their depression. So when we look at this is that we know the a for an effect of gastric stimulation. We know vagal nerve stimulators for depression has been around and so we're actually affecting the brain stem and this is really where a lot of this research is, is the brain stem involves our nausea and everything, so it's the affern effect is what many of us believe is the effect of gastric pacing. It, it's indirectly you're doing vagal nerve stimulation. So if you're less depressed, you have less nausea. Tom Abel would not agree with you, but you've never actually seen an improvement in gastric emptying in the adult population. So it's a little bit, but it's not better. I, I, I actually totally agree with you. Tom Abel has shown that there's actually much more coordinated gastric electrical waves after you've stimulated someone's stomach. So the point is we don't know. That's what makes us all so uneasy about it, but I will tell you that. The other, I, we, our patients know when their batteries die because they come back nauseated. We actually had one patient who was morbidly obese. By the way, a lot of these patients are overweight, which is really interesting, uh, and when we put in the stimulator, she lost 75 pounds and she started gaining weight again and feeling nauseated again and, and her battery was dead, which has led to the big FDA trials for gastric pacing for obesity, but they're also vagal nerve stimulator stimulating obese. A lot of that purely for that would be interesting to see. What happens to gastric motility or gastric emptying in patients who have vagal nerve stimulators for other reasons. That's true. That's it's, it's, it's an interesting. I think a lot of it has, especially the very, you know, the obesity gastric stimulation, how that works. Nobody knows, but it actually just passed this FDA trial, so you're gonna see more of it. It's been approved in Europe for at least two years now. That's great. Uh, Granado, you wanna wrap up and then it's a really safe procedure, you know, uh, uh, we, we haven't had any major problem doing, uh, uh, gastric stimulation. It seems to work. We don't have data maybe to prove that it's effective, but it seems to work in the limited information that we have uh in USA, uh, and, and temporal gastric stimulation is a good way to predict if this is gonna work or not because none of the patients that, you know, that that respond to the temporal stimulation failed permanent in our in our institution. One last question. How have you gotten insurance companies to pay for this to somebody that's always battling for insurance payments? We've never had a denial. We've never had a denial. Have you, Steve? We've never had, I mean, Amanda, have we ever had a denial? Steve doesn't take care of commercials. You know, it's, uh, actually we have had a denial. And the adults we get denials all the time. Yeah, I don't know why we don't. All right, thank you no thank you, thank you for the invitation, yeah. So just out of curiosity, how many of these have you all done? Uh, we've done about 2 blows 20 years, blows, Steve, how many? Steve's done more 1000. We've done, we've done, I think we've done about 25. Yeah, all right, that's great information. It's, it's very cool. We're finding some cool stuff that we could be doing to help kids.