Let's go to California. Dr. Kenneth Chang from the University of California Irvine will be demonstrating active procedure. Dr. Chang, you're live on. Can you hear us? Hi Venkata. Moeen, hello. Prateek, Reina. Hey Ken, good to see you. Good to see you. It's great to watch these other great cases. Thank you. So I wanted to first introduce in the room to my right is Dr. Alyssa Choi. She's our advanced fellow. Jay is our GI tech and Dr. Ninh Nguyen is our foregut surgeon who's here to make sure I do it right. So we're going to show you a TIF procedure. You've seen today's the GERDX and the ARMA procedure. So we're here to demonstrate the TIF procedure. The case is a 30-year-old male with two-year history of refractory GERD. Symptoms include heartburn, regurgitation, LPR symptoms, partially responsive to PPI. This is his endoscopy. Initially they thought it was a hill two, but on proper insufflation you can see it's obviously not a hill two. One centimeter vertical component, but a hill three. You can see you can drive your scope all the way through the hiatus there. The endoflip was done and the DI was between four and six. There were no racks. Next slide. Then the ambulatory pH showed a 48-hour wireless acid exposure time of 11 percent, both upright and supine. The MESA score of 40. Symptom association probability 100 percent for heartburn and regurgitation. And next, the upper GI showed no obvious hiatal hernia, but a patchless LES. Next slide. Okay, so then we can come back live. That's the... Ken, a question. You mentioned FLIP. Are you utilizing manometry in these patients or using FLIP mostly to assess motility? Yeah, in patients... Great question, Reyna. In patients without dysphagia on presentation, we used to do manometry on everybody, especially before a hernia repair, but now we're substituting in endoflip. It's much more comfortable. It's convenient. It's efficient. And if the endoflip shows no signs of achalasia, we're pretty much good to go. We don't need a mano after that. So here you reduced the hernia already? Yes. So the... there wasn't much of a vertical hernia, but Nin demonstrated a one and a half by four centimeter hiatus. So the diaphragm hiatus was hugely gaping, as you saw in the endoscopic picture. We saw it just now a few minutes ago on the laparoscopic view. So he put four interrupted sutures across, beautifully closed the hiatus. And that's the key. You've got to... in your patients, you've got to take care of the flat valve, the G-flat valve, but simultaneously you've got to make sure that the cura is also intact. It's like fixing the door without fixing the door frame. You got to fix the door and the door frame at the same time. Okay, you can go ahead, Ken. So what's the next step here? Okay, so let's go to the endoscopic view. We have it. Great. So the the TIFF device is already in place. It's the Esophix Z+, and the endoscope is inside the device. So the endoscope is coming out through the side port. So it's placed endoscopically. I just did that a few minutes ago. And then the scope comes out through the side port. So now you're looking at the G-junction in a retroflex view. And you can see here, what we're looking at here are the sling fibers. And this is the anterior sling fiber. And if we go the other way, that's the posterior side. So the goal is to recreate a flat valve, the G-flat valve, which will be three centimeters in length, at least 270 degrees wrap. And Mimi has shown in the TIFF registry that it's key to get beyond 270 degrees. And she showed in the TIFF registry presented last year at DDW, that you can get normalization of acid exposure to 84% if you do greater than 270 degrees with the TIFF alone. So the length is important, but also the degree of wrap is important. So you're creating a true flat valve, not just the tightening, not just the gastric glycation, but recreating the physiologic flat valve. Ken, there was a lot of discussion earlier about where you want to place the sutures and the pledges and stuff. So is there a difference on the lesser versus the greater? It sounds like you go all around or more than 270 degree around. Yeah. So the key is the flat valve is this part, which is on the greater curve and the natural occurring flat valve with these sling fibers will want to close from greater curve towards that lesser curve, which is on the other side at 12 o'clock. So it's like a door that opens and closes. It swings from greater curve to lesser curve. The lesser curve is the backstop. So with that in mind, you don't want to mess with the lesser curve because that's the receiving end. You want to tighten the sling fibers by making it tight around the circumference of the G-junction, tucked into the posterior corner, tucked into the anterior corner. And then on the greater curve, you want to lengthen. So it's not just a random tightening. You want to create an omega valve that's open towards the lesser curve, because you want the valve to shut towards the lesser curve. And because the cura is working in the exact same direction as the flat valve. So you want the cura and the flat valve to work in synergy, not opposing. So you're going to start on the lesser curvature posteriorly now? Say again? You're going to start on the lesser curvature posteriorly? That's right. So I'm going to rotate posteriorly this way. And Alyssa is going to circle the scope the other way so you can see the view this way. So now you're looking at lesser curve. I'm going to rotate my device. I'm going to now open, and I'm going to put my, there's a tiny little helical retractor that I'm going to advance from the inside of my instrument. And that's going to go right here along this G-junction, Z-line, right at around 11, 12 o'clock. I'm going to rotate that in nice and securely. And then what I'm going to do is I'm going to rotate out of the corner, like that. And then from here... And in this one, you went very close to the Z-line there. I mean, like we could see the squamous mucosa, correct? Exactly. Okay. So you want to go as close to it as possible. Exactly, as the anchoring point. So now I'm going to set the device by pulling it back and above 45 centimeters, 44 centimeters. And now I'm going to have Alyssa desufflate now. And so while she's deflating the stomach to loosen the stomach wall, I'm going to start pulling on the retractor. Stop right there. So I'm pulling, I'm pulling. You see how the retractor is coming towards me? That's creating length. Okay. Right there. Did it come off? Oh, I think we're okay. All right. Then I'm going to rotate this way. Deflate, deflate, deflate, deflate. Okay. I'm going to close, lock, lock, suck. I'm going to push off the diaphragm. I'm going to fire. So when I press the trigger handle, I fired two fasteners with stylettes. So now I'm going to open to show you, I'm going to reload first. So this automatically fires two nylon fasteners at the same time with every press of the trigger handle. And now when I open it up, you can see, you can see that we put some fasteners there along that posterior side. So I'm going to, I'm going to do that one more time. I come around this way. My helix came off, so that's no problem. We just go ahead and reattach the helix. I'm going to reattach the helix now. I'm going to grab right here. One, two, three. Nice and snug. Okay. So I'm going to rotate again. All right. I'm going to open and set the helix free. I'm going to pull back to about 44, and I'm going to have you de-sufflate, deflate, deflate. So I'm going to retract, retract, retract, retract. Hold it right there. Retract, retract. Okay. And de-sufflate some more. Now I'm going to rotate, rotate, rotate to about one o'clock, two o'clock, suction on, re-insufflate, push off the diaphragm. I'm going to fire. I'm going to rotate off. You can see the valve is coming in nicely already. I'm going to load my two fasteners. So I did one placation before coming on camera and two while on camera. So that's a total of three on the posterior side. I think I'm going to do one more because I've got a really good hold here. I'm going to put one more in. Okay. So let's have you de-sufflate again. De-sufflate, de-sufflate, stop. Okay. I'm going to pull more on the helix. So this time I'm going to try to get even more wrap. Deflate, deflate, deflate, deflate. Now I'm going to go all the way to two o'clock. Lock, lock, suck, push off the diaphragm, re-inflate, fire. Okay. So now I'm going to reload. So I'm working my way with the wrap. With each subsequent placation, I'm going deeper and deeper into the lesser curve and shallower and shallower on the valve. And that's what forms the omega shape. So now I'm going to come off and show you what we've done on the posterior side. So I take the helix off. I'm going to push the device in, close. I'm going to put the endoscope here. You can see that that posterior side has nicely come in. So now I'm going to go to the anterior side and Alyssa is going to follow me. Okay. So now we want to get the anterior side and same thing here. We're going to anchor right at the Z line because it's not a gastro-gastric placation, it's a esophageal gastric placation. So I want half the valve to be esophagus and the half the valve to be stomach. All right. So now I've placated well. Now I'm going to rotate in the other direction. Okay. And Alyssa, I'm going to have you deflate already. Okay. Stay right there. Deflate a little bit more. Okay. Stay right there. Okay. So now I am at 43 minutes. Okay. Deflate a little bit more. Deflate, deflate. Okay, good. Nice. So again, I can see you're in the OR, the patient's intubated. What's the, and of course, you're the world's expert on this. So your timeframe may not be adequate, but what should people who get initially trained anticipate in terms of a procedure time for this? About 35 minutes. So we just submitted an abstract DDW of this, the 216 patients, the average TIF time was about 35 minutes. Okay. I'm going to close here, suction on, re-inflate, and I'm going to fire. Okay. Look at that valve critique. Yeah. Nicely done. I mean, yeah, that's a, that's a gorgeous. The key as different from the other procedure that Amit showed and we'll get to it in the Q&A is that the rotation that you do, I think that's the one which really appears to, you know, create almost the sling fibers. Yeah. I mean, we're working with nature and reinforcing the naturally occurring physiologic mechanism of GERD. Okay. So now we're going to, so I'm still well attached there with my helix. I'm going to circle back this way. How do you decide how many placations you're going to do? It's based on how it's going or that's predetermined? We typically start with a baseline of 10 placations. Stop here. Three posterior, three anterior, four greater curve. And then, and then from there, I kind of tailor it to, to the person's anatomy. So I'm going to pull, pull, pull right there. I'm going to keep it right there. I'm going to push you this way. I'm going to have you deflate. I'm going to rotate now towards that lesser curve. Stop right there. Rotate, rotate, rotate, rotate. I'm going to rotate deeper now because with each one, I want to go a little bit more deeper into the wrap, which is right about there. Okay. Lock, lock, suction on, flush off the diaphragm, re-insufflate. I'm going to fire here. Okay. Ken, very nicely done. And again, the wrap is becoming more and more evident as you're putting in more placations there. So how about for your patients is, is this an outpatient procedure or do patients, are they observed 24 hours after the procedure? What's your protocol? Yeah. So when we do TIF alone, they're either discharged six to seven hours later or a 23 hour observation, but both are considered outpatient. Even 23 hour obs is considered outpatient. So the vast majority are outpatient. Okay. And I'm going to do a third placation on this anterior corner. And this time I'm going to just be more superficial on the valve. So I'm going to go to 45 and I'm going to retract a little bit less. Alyssa, I'll have you deflate now. Deflate, deflate, stop right there. Okay. I'm going to purposely not go so tight on the valve because I want to go low on the lip. Rotate left. Okay. Now I'm going to push a little bit more in. Deflate, deflate, deflate. But now I'm going to try to rotate even further to about, oh, okay. Great, great, great. 11 o'clock. Perfect. Okay. Suction on, re-inflate, push off and fire. So Ken, we have a couple of minutes for our Q&A. How are you looking on time there? Because obviously we'd like to have you participate in the Q&A as well. So how are you looking on time? I'm almost done. Yeah, we should have a few more minutes with Ken since he started late and then we'll leave maybe 10 minutes for the Q&A. It'll be nice to see the end of this. Look at that anterior sling fiber. Look at the length and look how the fibers are naturally in the right direction. And now the sling fibers, when they contract, they're going to pull this whole valve closed, which is the purpose. Now I'm going to go to the greater curve and I'm going to create some length. Did I reload? I did? Yes. Okay. Rotate right a little bit less. Perfect. Okay. Yeah. So here I'm going to anchor at around five, six o'clock. I'm going to grab that greater curve lip. I'm going to rotate in. I'm going to open the helix, open the tissue mode. I'm going to swing over to about five o'clock, which is about there and desufflate, desufflate, desufflate, desufflate, desufflate. Okay. So I'm maxed there. So here purely you're creating length. Suction. Yeah. I mean, this length is, it's going to be, I don't think I, it wasn't loaded. Yeah. Hold on. Okay. I'm reloading. I'm getting old guys. So I forget when I reloaded and I have three helpers. Okay. And you really nicely presented the symptom indices of when you showed the Bravo, when someone has a positive SI and SAP, does that increase your confidence that this will be a good candidate for TIFF? Absolutely. Going by Rina, your fetal type paradigm. I love it. The regurgitation heartburn predominant. Those are like home runs. The LPR predominant, not as much as you know. Okay. Suction on, fire. So that's the second one on the greater curve. I'm going to fire two more on the greater curve and that'll be our basic 10. And you've pretty much seen the whole thing here. I'm going to rotate the seven o'clock, these two plates roll, right? Max length, close, suction on, push in, fire, reload. Can you tell us about the learning curve for this and how long does it take for someone to get proficient at doing this? Of course, not the 260 cases you've done, but how about before that? Yeah. So I had the honor of teaching Mimi and she actually did a nice learning curve study. And I think it took about 20 that she felt very comfortable doing it. And she's a lot smarter than I am. So it took me 200. Okay. I mean, in my experience, it takes much less than 20 to learn it, but to become efficient and master it takes maybe 20 or more, but the basic technique, I don't think it's that difficult. And Moin mastered it after two. I thought you were going to say Moin knew it even before he started. All right. So, so that's it. Look at the valve guys. That's a beautiful valve. Now that's my basic 10. I'm going to do a little bit of touch-up. Did I load? So Ken, what we're going to do here, we're going to maybe keep your screen going and just on live, and then we can get the other moderators on the other speakers on. Let's go to back to Dr. Shang to show us the final picture of the valve. Ken, we're with you. Hey, hey guys. Yeah. So this is the valve. This is about a, about a 300 degree valve. The only part that's not part of the valve is that lesser curve that's spared right in this corner here. Otherwise valve, this is all valve. And I put some mid valve fasteners just to secure the inside, the middle of the valve. So this valve will look the same a year from now, two years from now, five years from now, this valve will look exactly the same. And we've had patients out seven, eight years and the valve looks intact. So the length of it is about four centimeters in length, but it's, it's, it's not, it's a floppy valve. The diameter is certainly narrowed, but it's not twisted and kinked. Sometimes laparoscopically with a Nissan, you can actually, you know, twist and kink the valve. This is a straight uniform valve because, and it, you know, the device is a 60 French device. So there's no way you can over tighten. And this is the optimal flat valve. And, you know, the argument is whether, whether now this, you know, rivals a laparoscopic approach because the surgeons will say, well, I, you know, I can do this. I can do a partial fundo. I can do a toupee. I can do a door. You know, why should, why should we do this? And, you know, my opinion is this is physiologically an optimal flat valve. And if we don't need a hernia repair and we can do this endoscopically purely, obviously that has a great advantage. But even in combination with a lap repair you know, we're doing the head to head multi-center randomized control trial out of Mayo. We've got the registry study. I think it's promising that this will be very much become a mainstream anti-reflux strategy. And it's nice because GI and surgeons can play together and, and collaborate and do these patients in a collaborative way. So anyway, so that's. No, great. I mean, Ken, excellent result. And just looking at that, I mean, you know, as you mentioned, after a laparoscopic fundoplication, we would see very similar sort of a wrap, which has been done. So excellent demonstration of that.

TIF procedure

Transoral Incisionless Fundoplication

gastroesophageal reflux disease

GERD treatment

EsophyX Z+ device

physiologic flat valve