The first session is going to be about pH capsule placement, pH impedance, manometry, and very briefly about FLIP, and I'm very pleased to introduce our first speaker, who is a dear friend and mentor of mine, Dr. Canto, and she is from Hopkins, where she has been for I believe about 30 years at this point, is really a legend within the field, and she is going to talk about pH capsule placement. Thank you. I'm supposed to speak on the diagnosis of GERD, but focusing on the wireless pH capsule placement, or the Bravo as we know it, and so no disclosures. So I want to focus on back to basics, which is the what, when, why, who of Bravo pH capsule placement, and really just to briefly review the principles, indications, inclusion, exclusion criteria of using the pH wireless capsule technique, and focusing more on the technique of how, and which is really kind of basics of what things we can share with you, tips and tricks for Bravo capsule placement. Certainly we can at the Q&A talk about any more concerns or questions you may have. So troubleshooting tips, also very important as you do this in your practice, what happens and how to deal with that. So what is the Bravo capsule pH test? It's a capsule with a pH sensor, as you see here in the middle screen. It's placed endoscopically, typically in the distal esophagus, and wirelessly records and transmits the pH information to a portable small data recorder that you can see right here on the right image. And so as you can see, the endoscopic placement is through a catheter, and you position it strategically in the distal esophagus, so it captures distal esophageal pH information. Now why do ambulatory wireless pH testing as opposed to the catheter pH testing, which John will review? Well, it does measure a very critical piece of information for diagnosis of GERD, which currently is mostly focused on the average acid exposure time over the days that we record, and the days are either between now and the days two to four days of monitoring. The objective diagnosis of GERD, as you know, based on the Leon consensus, is really focused on the average exposure time, where we know with a high certainty that if it's normal acid exposure time, less than 4%, it really excludes with good likelihood that the patient does not have GERD. And certainly if it's abnormal, beyond the threshold of 6%, that it's more likely that the patient has GERD. And somewhere in between, before 6% acid exposure time, it's recommended that this is borderline in terms of levels of acid and needs further evaluation. Now the Bravo capsule, as you'll see shortly, is easy to perform. It's also probably most widely available across most parts of the world. It actually has better patient tolerance and acceptance. And certainly with the increased monitoring over two to four days beyond the one or two days we had previously been doing this, it increases the diagnostic yield and reproducibility. So certainly probably much more desirable to approach it from a wireless ambulatory perspective. So who can and cannot get a Bravo test? Well, what are the indications for doing the test off therapy? The main indications are for evaluating patients with GERD symptoms and normal EGD, non-erosive reflux disease, prior to any endoscopic or operative GERD therapy for documentation of severity. For atypical symptoms like chest pain, where you want to make sure that there is a likelihood that GERD is causing the chest pain. For patients with typical GERD symptoms, but who are refractory to a trial of once or twice a day daily PPI. And certainly this is important for you to discriminate between real pathologic GERD and the other two entities you should know about, which are esophageal hypersensitivity and functional heartburn, which I think John will cover. Now you could do the Bravo pH testing on therapy in certain select indications. The question in this population is not whether they do have, patients do have GERD or not, but essentially to assess the pH control on medication doses that they are on. And certainly for postulant-responsive GERD patients with Barrett's esophagus, this is when you might consider doing it on therapy. And sometimes we'll do it on and off therapy. And again, it depends on the question you're asking. Now there are contraindications to Bravo pH capsule placement. And one of the main ones that you want to ask about is metal, particularly nickel allergy. And so you could ask, you know, particularly women, do you have an itchy rash when you wear earrings or necklaces or bracelets? Certainly pacemaker defibrillator patients should not undergo Bravo. And other things are pretty obvious, pregnancy, bleeding, varices, strictures. And obviously when patients already have clear severe GERD, when they have grade C or D esophagitis or Barrett's, you don't need Bravo or caps or pH testing to prove or diagnose GERD particularly. Now how do we prepare? Well, we definitely pay attention to patient instructions when we talk about pH monitoring of any type. So what to do with meds, this is very important because you interpret the study based on whether they're on or off. So we actually tell patients to stop their PPI at least seven days before they can take extra blockers up to three days before antacids up to a day before, and certainly none during the two to four days of monitoring. They will get instructions from your nurses, but you should really have them review this because it's critical for particularly the association part of pH of acid pH with a symptom in particular. And if they do have a symptom, this is something that the patients don't know to press the button as soon as they can, particularly within two minutes, if possible, because sometimes patients have a heartburn, they go to the kitchen, have a drink and come back and then, oh, press the button. So that will be somewhat not so desirable. They can drink normally, but no sipping over long periods. They can chew gum or hard candy, keep the recorder within three feet or wear it on a belt very close, the Bravo monitor will beep at you. And certainly no MRI for 30 days, if there are patients who do have an MRI scheduled, we sometimes actually confirm Bravo absence by an X-ray. What are the risks? They're very, very low, but certainly something to just know about and review with your patients. There's a theoretical risk of aspiration pneumonia. There is a very rare risk of capsule aspiration, which again, I'll mention later. And finally, since you place the Bravo through a mucosal attachment, a mucosal tear is certainly a theory possible, laryngospasm, airway compromise, chest pain, again, something I review routinely. It's unusual, maybe one to 2%, probably a handful of patients in my practice over many years that I've had to actually redo endoscopy to take off the Bravo because it was so painful. Failure to attach, which we'll review because of potentially issues related to the placement, premature detachment, which falls off before you actually have enough, like 24 hours of data to interpret the study, and failure to detach, you may need the endoscopy again to remove this. But again, overall, the risks are extremely low, and this is really a safe, safe procedure. Now the Bravo pH capsule consists of a catheter, it's mounted on a catheter as shown here, and the pH sensor is at the tip. This is a magnetic clip that your assistant will remove, and once you remove this, it turns on the capsule, and a close-up view of the capsule on the right shows that this is the suction chamber, where when you suction, the mucosa will be suctioned into this chamber, and this is the trocar needle, which allows attachment to the mucosa. Now how do we place it? Well, here are the steps, something to just remember that they're, it's very easy, but they're little nuances of the technique, which I want to demonstrate to you right now. So what I do, and again, people may do this differently, obviously the patient's sedated on the left side, and what you want to do is really hold the catheter, have stability by holding the scope in place, and your assistant will obviously hand you the catheter, Bravo catheter, as shown here. And what you want to do, and this is the way, again, I do it, but you want to be parallel to the scope, and you can see here the patient's coughing a little bit, and as you're doing that, you're actually looking at the vocal cords. So as you see here on the right, you want to get a good view of the vocal cords, you want to be sure that you don't, that you place it into the esophagus, and if you do, in fact, put it into, either close to or into the vocal cords, you may cause laryngospasm. And so this is really a safer way to do it. You can actually then visualize, potentially, that you have the catheter in the esophagus, and then once you have it in the esophagus, I want to just show you this one more time, sorry. So you actually have to turn the catheter so that the Bravo, as you can see here, is facing downwards, and the tip, again, is such that it will, if you follow the axis of the scope, will go directly in where you want it, which is away from the vocal cords into the piriform sinus. So again, just nuances of safety here. So now, in the next step, you want to advance, I advance the endoscope to the proximal esophagus, because if you keep it there, sometimes the patient may have stimulation with that scope in the esophagus, it's actually quite stimulating, the patient may cough, but alternatively, you could remove the endoscope, which is what some people do. I prefer to keep it in, because then when you look to confirm later on, it's already in the esophagus. Now, with the vacuum off, as I've shown here, you're going to now position the catheter, the Bravo, according to the landmarks that you've taken, approximately six centimeters above the GE junction. So you're going to now position, you can see my hand looking to see where the catheter markings are, and I hold the catheter with the scope, someone's going to help me stabilize it so that they both don't move, and so an assistant will hold the scope, I'm getting now the end of the catheter here. Now you can attach it to suction, which is what is also critical for moving that mucosa into the capsule, and so you hold the catheter in place, anchor at the bite block, which is step two. So let me just go next. So now the step two, you apply the suction for 45 seconds, you should check that there's a minimum pressure of about 550 mercury, and so this is what happens, right? You have the catheter here, you have the suction which allows the mucosa to go into that port, and I did this video to show you what actually happens, normally we don't look at it like this, and usually I actually suction to ensure that there's actually, the mucosa has collapsed onto the catheter, but this is what happens over the 45 seconds that we're counting, looking at the clock, is you're actually trying to promote enough time so that the mucosa adheres to the catheter, and again, the mucosa is being suctioned into this space in the capsule, and this is what you see here, you can see now the mucosa is attached into the Bravo, and so the next step then after that, making sure that you wait the full 45 seconds, I've cheated in the past, 30 seconds sometimes results in not enough time for the mucosa to suction in, so just, you know, crack some jokes and talk about recipes or what you're going to do for the weekend, and just wait the 45 seconds. So next is the capsule attachment, so here, pretty critical too, is to depress the plunger to advance this trocar needle through the tissue, as you see here, and so once you deploy it, this needle will be in place, and so therefore the capsule will be attached by spearing the mucosa, as you see here, and so you want to make sure too that this is critically important, that on the markings on the plunger, that you see this critical sixth rib, that in fact it has to be completely depressed, the plunger, and then you can now release it. So I'm going to demonstrate that to you next, and so there's two techniques, I prefer the other one, but there's two ways to do this, one is called the one-hand technique, so this is my hand, I have small hands and short fingers, but you can do this certainly with one hand, so you take off the white protective piece, you press down the plunger, you click it to the right very quickly, and you push up on the plunger to make sure that you have this sixth notch visible, there is a click that you feel, but again, you have to be able to push this up completely and rotate it very quickly, let me show that one more time, very quickly, take off the white piece, press down all the way, turn it with your hand or fingers, push it up, so you can actually make sure that the plunger is completely released. Now the other technique which I like is the two-hand technique, because it's really more stable I believe, is when I hold it with the left hand, you push down with the right, push all the way, you feel it, and then so this actually can pull back, the right hand pulls back on the plunger, you can see this sixth mark easily, and it's really reliable, really guaranteed to have no misdeployments, because you know that all the steps have been completed with great stability, but again, either way is fine. Now once you have it deployed, what I do, and certainly this is really encouraged, is you verify that in fact the Bravo capsule has been attached, so I've, with the scope already in the proximal esophagus, I just re-insufflate, push the scope down, and this is the view you get, you turn off the suction, and you endoscopically confirm the capsule attachment, so this is what you see sometimes, is you're not sure if the capsule has completely been released, and you see, you have to make sure of that before you pull back this catheter, and sometimes if you're not careful, this end of the catheter can actually bring the capsule off and detach it, so I'm making sure here in this video that I'm trying to turn the capsule so that this curved side at the end is not going to pull back when I pull back the catheter, as you can see here, so I'm turning it, torquing it to the right, and I'm just going to flip it with a clockwise torque so that I can easily remove, you're also insufflating to make sure that you are not going to remove the Bravo capsule, and then once you visualize that, you take a happy picture, smile, and you document that the Bravo capsule has been in place. So that's the end of the technique. Now troubleshooting tips and tricks, very important, what happens when things happen. So you want to know what to do, and so one of the things that you need to know, which again is very, very rare, I've actually not had one in ever, I think, is what if the capsule does not detach? Well, here's what you do, this is the position of your hands on the end of the catheter, one hand is on the catheter plunger side, and the other hand, which is where the suction catheter part is, the other hand is on the opposite side, so this is what you should do, so you secure the handle at the mouth, make sure that you break the catheter with two hands, and then you would draw the handle greater than four centimeters to release the capsule. This will keep the capsule in place, but allows the wire that holds the Bravo capsule to be withdrawn so that you can now release it. So here's the demonstration, it's a lot of, you know, kind of quick force like this, okay, so it looks hard and I'm not that strong, but it's actually not that hard to do, but that's what you should do if that should happen. Now what if the capsule is pulled out from the catheter, like you basically pull the catheter out while the Bravo capsule was still in, as I showed you, and the capsule is detached but it falls out in the back of the pharynx, so that's a little bit of an anesthesia disaster if I would call it, they get very nervous when there is a foreign body close to the vocal cords, and I know that John may have some stories about this, but what the anesthesia staff prefer is that you actually fish it out with this Kelly forceps, Kelly clamps, so that it's all under visualization, they use a direct visualization method to remove the Bravo capsule. Again, this is extremely rare, but it can happen, so again, use your anesthesia colleagues, it's better to do this than doing other things like, you know, getting a polyp snare or whatever you use, this is just quicker and safer. So in summary, I want to say that the ambulatory wireless pitch testing using the Bravo device is most popular, best tolerated, and easy to perform, as I showed you, widely available across many parts of the world, and it's certainly pretty essential for diagnosing pathologic GERD.

pH capsule

gastroesophageal reflux disease

diagnosis

wireless device

endoscopic placement