The Sentara Heart Valve team, Dr. Summers, Dr. Talreja and Dr. Kemp, performed a LIVE Transcatheter Aortic Valve Replacement (TAVR), moderated by Dr. Adler. This is a minimally-invasive procedure performed by inserting a new aortic valve via a catheter to replace a damaged valve.  The TAVR procedure displaces the diseased valve and the new valve is deployed in it's place. This life changing procedure can be a better option over traditional open-heart surgery for some patients due to faster recovery times.Â
Originally Broadcast: Friday, March 15th at 11 AM ET
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Good morning and welcome. We're broadcasting live from the Centre Valve Center in Norfolk, Virginia. Delighted to have you join us for a live case today. We have an international audience today. So I welcome all of you from time zones uh across the world. Uh Our implants today will be Dr Matthew Summers, Doctor Deepak Tarea, doctor Clint Kepp and Sarah Kennedy assisting. My name is David Adler and I will be moderating the case. Today's case is going to be a, a Valve and Valve Tavern. Uh We've selected a great case uh for learning today and I hope you enjoy the case. I'd like to start with a quick summary of the case. Uh We've met as a multidisciplinary valve team as we do for all of our cases. And this is just AAA brief look at the folks that are involved with that uh on a regular basis. But uh the number of team members that are involved in preparing these cases is too many to list. But I do want to thank everyone that's involved and, and what it takes to get patients through this uh process. Uh This is this patient's summary slide. It's an example of what we present at every multidisciplinary valve conference for every patient. And as you can see, we have uh a synopsis of the patient's presentation uh which is comprehensive and allows the heart team to thoroughly evaluate the case. Today's case is a 67 year old female. She's had a prior surgically ordered valve replacement in 2008 with a 21 millimeter magna valve. Uh She's also had a history of a pericardial window. She's got a preserved left ventricular ejection fraction has a remote history of tobacco use. Her labs are fairly unremarkable. She's got a narrow QR s her echo uh demonstrated sever aortic stenosis within the bioprosthetic valve with a V max of 410. Uh She's had some mild A I cardiac catheterization, demonstrated mild nonobstructive coronary disease. And as you can see in planning, uh we use CT uh to assess for access and also plan our valve implantation and uh we'll return to some of these measurements later. Uh obviously with uh valve and valve tver that's uh requires careful planning and uh the, the teams put a lot of work into uh planning her case today. And uh doctor Summers, Doctor Taraia will address that in more detail. Uh her sts risk uh was uh considered high risk uh with 5.1% sts score. Uh We do assess every patient for a bailout plan and she was considered uh a reasonable candidate for a full Ronon bailout. Uh We've selected the 23 millimeter evolut valve today and uh we'll discuss later our decision process there. Uh Access will be via right femoral artery. Um Wanted to briefly discuss our planning for valve and valve ta. Uh There's an app that can be downloaded to the phone and uh this is very useful in planning. You can see you can, you can look up uh the specific valve that the patient has. And uh there's quite a bit of information there, including fluoroscopic markers, uh recommendations for balloon sizing for valve fracture and uh for planning of implantation. Uh A couple of topics that we'll be discussing today. One is basilica which is uh leaflet modification of the bioprosthetic valve to avoid coronary sequestration. Uh when the new valve is placed, uh there is uh always uh a consideration whether the leaflets of the bioprosthetic valve could uh include the coronary arteries. And so there's careful planning that goes into uh uh whether or not there's a need for leaflet modification and that procedure is called basilica. We'll discuss that a little bit more today. Um CT is essential for planning that and uh this is the patient ct scan as um you may have noted earlier. There were pretty low coronary heights. Uh The, the measurements that we look at our coronary heights and the, the coronary sinus size. Uh Again, we'll talk about that more, but just wanted to provide you with an example of what we're looking at as we plan the case. Um A basilica procedure involves electro cardio surgery. We uh have a, a wire uh across the leaflet. Uh We electrify the wire and then lacerate the leaflet of the bioprosthetic valve. Um And uh we'll discuss that again more uh preprocedural ct A as I mentioned. Um the other topic that we will discuss is valve fracture. So, bioprosthetic valve fracture is a consideration. Uh And uh we'll discuss that more. So I think with that uh ba background, uh we're probably ready to go over to the case and uh is the team ready? Yeah, I think we're ready. All right, Doctor Summers, Doctor Tara, Doctor Kemp, uh you want to introduce the folks in the room? Sure. Sure. So, um Matt Summers, um they've mentioned, I'm part of the structural heart team here with Tre and Clint Temp are excellent c lead uh for structural heart uh in the room. We also have Doctor O Pet, who's, who's one of our best anesthesiologists, cardiac anesthesiologists um in the room, we also have some incredible texts. Uh Katie Candace and Syra all monitoring. We have uh echocardiographer, uh Chris, um and we have a surgical team as well on standby. Uh given the, the nature of this case, she's a fully uh if uh we had to convert um Deepak. Uh Do you want to talk a little bit about um where we're at at this point with access and things. So, so Matt moves at such a fast pace. We were worried, we, we had done with the case before the broadcast. So we had to slow him down a little bit here. He's got uh access on the left side, an arterial and Venus sheath in place already. As you can maybe see on the forest screen. You wanna just uh show live what we've got, you can see on the floral screen. He's got a temporary transvenous pacemaker up from the left femoral vein, a pig tail from the left femoral artery. You can see the sternotomy wires and you can also see the uh the old frame of the previous valve that we're gonna be treating as, as Doctor Adler nicely described. You see AJ wire up, there's an eight front sheath with two P loss. Doctor Summers put in earlier to facilitate closure at the end and we paused and uh and had a little conversation while we waited before we put in the big sheet. So you could see the rest of what happens. So, so just to piggyback on what Dave uh presented with this case, this is a, a very nice lady, but she, she demonstrates what we talk about commonly in our valve conferences, which is lifetime management. So she had a really excellent surgery in Buffalo when she had endocarditis in 2008 and she had a 21 millimeter uh magnet 3000 or T FX valve placed and she's gotten more than the average or median time out of this valve before it finally generated, which she had close follow up by an excellent cardiologist who identified that the valve was stenotic very early on. And so she's coming to us electively in very good condition right now. Um And we've mapped out the rest of her life really as far as which valves we saw. Um and um our approach to valve selection here, Kim, do you want to talk a little bit about why we use evolut in these situations? You do a lot with hemodynamics. Sure, absolutely. I'll talk about that. But before that, I'll say I would agree, she's gotten a very long run out of this valve and she was operated on in the era before tver. Now that we know that lifetime management is so key, we actually change from a surgical standpoint, what we do upfront in the patient that gets the bioprosthetic valve. Um in terms of why we use evolut, it's very simple, excellent hemodynamics and a super angular design which allows us to be able to implant this inside her surgical valve without having to go intra annular again. So evolut is absolutely the way to go here. It's what we do here at the heart center. So Dave talked about basilica which for, for the, the folks that aren't structural hard on the phone uh on online. Uh It's a procedure to, to basically reduce the risk of a catastrophic complication which is coronary occlusion. And in her, the screening here, the the coronary arteries were low at six. Anything under 10 is kind of a screening test for looking close. But really in all bioprosthetic valves, you should be looking cause the the rate of coronary occlusion is high. Importantly, what we do is virtual valve implantations. Again, this is for the nonstructural heart folks, we implant a valve in her CT scan and can measure certain parameters. So in her with a 23 T FX valve that has a 20 millimeter inflow. And so we embedded a 20 millimeter valve and looked at the distance to the coronary osteo. It's called the VTC and the distance from the valve to the TJ. What that tells us is both, are we going to include the coronaries? In spite of the low, the low heights. And also are we going to sequester the sinuses? So you run into problems when you don't get flow into the sinuses because they're sequestered by the tavern or when the old bioprosthetic leaflet props up and includes the coronary artery. Now, in her, these numbers were all above the threshold, well above the thresholds in spite of um the corner heights being low. Um Dave, I think you have the numbers in front of you but the VTC uh uh for the left and right were both uh 4.5 and five, the VT SS TJ was six and we look for numbers really under three. and for the VTC and, and really over 1.5 for the VTS TJ. Um anything we hadn't talked about as far as planning up to this point. I add as a compliment. You, you've gotten us involved in some of the latest trials on the cutting edge of looking at uh leaflet modification. In addition to basilica, which was mentioned, there's newer devices coming out and I know we're participating in a lot of those trials. You're serving as P I and for example, the Yeah, so there's dedicated devices coming out. Now in, in this, as Deepak mentioned in this case, we've looked very, very closely at, at coronary inclusion when that happens, it's really a rush to get folks on ECMO. And so we try to head that off because it's catastrophic uh complication. And we're confident with what we have right now that we're, we're not going to sequester the sinuses or include the corna basil basilica. We do quite a few of those, but it's a more complex procedure. Dave mentioned that involves electrified wires and lacerating leaflets. So it's not a benign venture when you go through it. One of the nice parts about the evolut as Kemp was talking about is we don't have to release the valve, we can deploy it at 80% and take a good shot, an aortogram and then prove what we suspect, which is that we're not going to have issues with Coron, we think to add on that. And then we got to get started the case. Any thoughts about when, when you would think about surgery instead of tavern, a redo like this? Sure. I mean, she certainly has that as an option. She's got lots of risk factors that make her higher risk for sure, morbid obesity, sts risk of almost 6% and then a nature. Um So one option would be if somebody wants to switch to a mechanical valve, I have to say I haven't found too many people that like that option. That's one. But to Matt Deepak's point, we spend a lot of time planning to put, proves that a patient has feasibility, but there are sometimes where the Coron are just female or let's say she had serious coronary disease and she needed a cabbage as well. Those would be sometimes where we would um do a reading. Let's talk about what's happening next. So uh Doctor Summers Aquis wire up through an A L one diagnostic catheter. You see the A L one in the descending portion of the AORTA and the Lundquist coming up through that, that'll facilitate our placement of the large sheath. What sheet did you select for this man? Uh We have a Gore which we like. Um It's important. One of the things that we do that I, that I think is important is these are stiff wires and we're trying to preserve the LFMO. So we always exchange for the stiff wire over AJ and an end hole catheter. Um But we have our stiff wire and the Lunder double curved Lundquist and we're backing out the eight front sheet, we're now going to put in the large board sheet. We're already heparinized, confirmed it. We're therapeutic. As uh Deepak mentioned, we have a, a path to fixation, temporary pacemaker in from the left femoral vein. And although you don't absolutely need it. Uh for visualization for the deployment, we have an angiographic catheter coming from the uh left femoral artery that will help us uh take uh pictures at the end to prove no PB L and also for the corner, as we mentioned, OK. Do you wanna talk a little bit about closure devices and why we select the ones we do? Yeah, deepak you, we've been through all the iterations of every closure device, isn't it? We, we, we started with tur closes and obviously the TC closes have iterated over time. We had a, a period where we use the manta device and we still use that as our bailout. But currently, our technique is two per closes, often you'll get good closure with just one. And if those two per closs don't give us closure, we can easily put an angio seal or even another per close right through that. Um We obviously have great vascular surgeons that back us up when we need, but that's quite infrequent in this day and age, especially as we've watched Sheet Size go down anticoagulation wise. What have you got on board so far? We've got full dose heparin, which is our standard. Um, as Deepak mentioned, um, we like to before we get the big sheath in at least partially heparinized and start getting uh therapeutic that way. But we've got our large four sheath in and Doctor Kemp is a world expert in crossing bioprosthetic aortic bowel, no pressure. Um But these can be very difficult to cross, especially when they're stenotic as this one. And you see us moving around and shifting positions throughout. It's, it's neat as, as a program right now, our surgeons, our I CS, you know, everyone can work in any spot and we have a great team approach to this and I think that's fantastic. You guys get a glide wire. So we have a step wise approach. Um As most people do, I know that the server operators on the phone, we typically use an A 01 and a straight wire, which is pretty common practice. Um And if we have issues, we'll use a straight supportive glide, we're going to take some baseline measurements too, which will help us not only see how severe the stenosis is, but also see our results at the end. So we had a question from the audience about the, the, the size and type of valve, we mentioned it earlier. We're, we're planning a 23 millimeter evolut self expanding valve. Is that correct? That's correct. Right. So, um that's based on what we know off the bench as far as the dimensions of the old T FX file. And so really that there's something called a true ID. All of these uh stented surgical valves have different dimensions on where the stent itself is mounted. And so this is one of the valves that is, is what we call fractal. So we can uh dilate the old surgical valve uh with up to 300 P si basically uh 10 car tires worth of pressure and actually fracture that surgical valve if needed, which is something we'll talk about in a little bit. Um But we're gonna use hemodynamics really to, to make those decisions. Speaking to the sizing, this is what has been demonstrated in boats, uh a valve and valve app. Um And we correlate that with what we see on CT and make sure all the measurements make sense. Um But this size is appropriately for 23. I think that's really important too. It's not just the radiographic picture or the echo how things look. It's really the hemodynamics that are gonna depend, uh are gonna basically tell us whether we need to post dilate. One other thing that um the companies have done too from surgical valve standpoint is knowing that there will be valve and valve designing surgical valves that we're now starting to put in that either have a breakaway sheet in there or have very low struts and very low leaflets to avoid potential need for basilica down the line. It's amazing to see that evolution in the field where we're thinking that next step ahead now and that synchrony between the cardiac surgical and interventional. All right. So, so Dr Summers is going back in with the Lundquist wire, he's got that catheter beautifully positioned in the apex and this will give us nice support as we go up and around with the uh device. We, we talked about valve selection a little bit. I mean, I think, I think it's pretty standard, at least for us and in most places, uh at least in the us that we try to get improved valve performance with hemodynamics um by the super annular valve like Dr Kemp was talking about, we, we do occasionally do Sapiens inside valves, but we try to avoid it to be quite honest, only if the sinuses are really uh gonna be sequestered. Um And one of the things that used to come up, at least in our valve discussions is, is it easier to just put a SAPIEN and now and then do to set the patient up for an evolut inside S3 and inside Sr as the third valve, if someone's gonna have a three valve lifetime management, but we've really shifted away from that because of the feasibility of cain TF and evolut, but also our surgical capabilities. Um And do you want to talk a little bit about? We've had some of these come back uh years after their, their TVER and you've had to ex plant them. So, yeah, so TVER, ex plant kind of runs the whole gamut. It depends on how long the valve has been in there and with the where removal is um not surprisingly, valves that have been there, um not as long or valves that are, are being removed for endocarditis are usually easier to get out. Um I don't think any one surgeon has a large group, but anecdotally, at least at our center, I do feel that the evolut is easier to get out because oftentimes, especially if it's not intercalated into the aorta, you can take advantage of the night and all properties, put cold saline on it and have the kinds and everything sort of move away. Um One other thing I'd mentioned too is and another reason to use an evolut here, especially if you're worried about coronary access is that surgical valve was put in under direct vision, that surgeon knew exactly where all of the commis were. All the posts are lined up properly with the evolut. We're going to show you the techniques on how to do it. We will get commercial alignment. We won't undo the work that was done in 2008. That's a great point. Another reason to use an evolut over a SAPIEN in this uh indication. We just, we just flur the valve. That's an important thing for folks that don't use a lot of evolut deepak. Do you want to talk about why we do that? Let me play it back while you're getting, we just saw you do a shot of the valve. Can you explain to us what uh what that was? We're going to talk about it now, while, while these two are working, what what we do is we almost floor every valve before it's loaded up on the wire or place. And the idea is you're looking to make sure that there's nothing that would suggest the valve doesn't have full capture where the uh where, where the uh the deployment section is. We want to make sure that the paddles are attached and that makes the release uh successful and low risk with this generation. You can see the three dots that will give us our coronary alignment. And in a second, I'll just show you that picture one more time and um not to interrupt you. But the first step to commercial alignment is while we're putting this in, we have the flush for at three o'clock. And that's something all of us, Sarah seeing it first. If she notices it's not there, still adjust it, then I will, then that finally, when it goes in and let's come back to that. So first what we see is this is the original stop. You can see this is just over the patient's chest and we're looking under floo by the, by the 4th 3rd to fourth node, we should see that any, any skirt alignment looks good. This is a good looking one. Metronic has a nice sequence of decks that it's worth reviewing of mis loads. And again, it's easy to reload, but this is the time to identify it. So now going on the live floor to doctor camps Point, Dr Summers and Dr K are aligning this, the, the, the camera is in an LAO position and we're looking at the hat marker. First of all, we align the flush port to a three o'clock position and that gets us there 80% of the time and in the remaining time, you want to make sure that the hat marker is on the outer curve here, which they have it beautifully shown there. If you look at the distal end, the top end of this valve, you see that there's a radio P portion extending to the right or outer curve and that's the hat marker. And as Dr Summers advances this, we'll see that that stays on that outer curve. So, and to Dr Kemp's point that gives us good alignment of the Corinna, which is unique to this platform. A couple of things we've done procedurally. So we use a double curve LST and we mentioned commercial alignment. Um This is all task at commercial alignment as Doctor Kemp mentioned. But this is the only valve platform commercially that we can guarantee over a 90% commercial alignment rate if we follow these steps. And that's important. I was on semi call last night and did someone with an S3 inside a sr and commerce weren't aligned. And even though it was an S3, it was almost impossible to get through the correct uh uh Strat that was the anor sty. So it is a critically important thing to ensure that there's lifetime management. We're gonna come across the aortic arch and what Sarah is doing right now is she's tension the wire just to pull me across the arch so that I'm not scraping. She's doing a beautiful job. And then once we get to this point, we kind of reset and let the uh the torque and the system work itself out. Notice we have our pigtail still in the descending. That's just to keep everything beyond the aortic arch until we absolutely have to, we're going in in that LAO position and we still see that hot marker on the outer curve that again gives us encouragement for coronary alignment. And you can see with this generation, the valve, you see those three dots uh that are markers that really help with our alignment. These are estimated angles obviously, but we've got a valve in place to give us true angles. It really almost an A P that gives us a, a cola view. You're saying, Ao Coal, what were the pretty good? Yeah, nice. That's gorgeous. The posts almost show you you can imagine in your mind a patient without those posts, how this gives us such a nice starting position where we can gauge depth to minimize need for pacemaker. Yeah, if you want to speak to, to your target depth with this valve and where you plan to great point. that's exactly. So we really want to be, the dots are three millimeters um a depth from the bottom of the valve print from the onset of the inflow. So we use that as the marker. We want to be one millimeter beyond that. So four millimeters beyond the lowest portion of the surgical valve is our target. Um Hemp is going to lead us through control pacing and this deployment while Sarah and I work with managing the wire and advancing the catheter and at the same time, right. So Katie's gonna turn the Pacer on to about 120. So it's not rapid pacing, but it's controlled pacing to avoid any PV CS. And I'm gonna slowly unroll here typically till about the third note. And while he's doing that, we've got a coordinator, we do so many of these together that uh we're, we're moving in unison. Sarah is actually tension the wire to keep us uh from coming too high and I'm also pushing in a little bit. She's pushing in a little bit to create a backstop. We're gonna come to that third note. So right now we're at three millimeters, we just want to be a millimeter up below that. This gives us room to do fracture if we, if we too high and we have to post dilate, it gives us the risk of pop out. So let's take a picture here. Left one, right. So we got all three dots underneath. Um It looks like we're in the right position. We're maybe a touch deeper at five. Sarah is going to push on that wire just a little bit. I'll make a quick comment. The two dots on the left tells you you've got your alignment, it fits with everything we've seen before. And one thing you guys should pay attention to is the human dynamics are just very stable right now, even with rapid pacing or relatively rapid pacing at 120 ish where our blood pressure is 130. That's one of the beauties of this platform is most of the time right now, the pressure dropped, right? This is the one part where the valve isn't functioning and now it's starting to climb up again and we've got pressure again over 100 now beau beautiful really. So the target depth, at least in two of these, you can see it slid down to do a little bit deeper than we would like. And because the valve itself, the surgical valve and a strengthen valve are not completely coaxial. It's less important in a valve and valve that we do what's called cusp overlap. So we're gonna recapture here in a cle review and do a partial recapture and pull back, ok. But we're gonna pace at 120. That ability to recapture and get the position. Perfect. Really is a nice feature, ok? Then push a little bit on your wire all C I like that. And sometimes these set where they want to set to go, that's gonna be it. At least in that other cost part, you can slowly back off Pacer. That's kind of where it's settling out. We really uh aim for a 0 to, to 1 maybe two, sometimes implant. So we're trying to target at most in a native vowel, those dots at the bottom of the uh the that the true uh uh annulus and this, it's, it's a little bit on the lower side, but we've deployed it twice. It's kind of where it's finding its groove. The other thing to note is and you know, we're worried about sinus sequestration. So the goal is for, but I'm more than comfortable with this. The rates of pacemaker are lower in patients with bowel and bowel and we may need to frack based on the appearance of this. So um we talk through this in every single case is why it's so useful having uh multiple people in the room to make these comments. How about we survey them and uh and see what they think. Those of you in the audience. I know we've got a, a large Metronic group watching. We're gonna survey you and see uh votes for leaving this versus votes for trying to recapture and deploy. So that's gonna be the question. And by raising hands, I know you've got someone that can communicate back with us. The question is a, how many people would deploy this where it is b how many people would recapture and try to redeploy knowing what Dr Summers just said. So we've had two good positionings where this looks like uh the spot that it kind of wants to see. I'll just remind folks in the audience. Uh We, we have chat functions so please feel free to chime in and uh ask questions and uh and uh you can, you can give us your uh vote for whether we should deploy or uh partially recapture and adjust our height, maybe, maybe Doctor Gaspar and Doctor Bora, you guys can uh survey your audiences there and give us a, a consensus answer from the group. We're starting to get some votes in. And uh so far the consensus is to, to leave it nice. The only piece of information we didn't have is what Doctor Summers just did. And that was the root shot or a sending shot to look at the corner at 80%. What do you guys think about that in the audience. I think I love me. It really does look great. Yeah, we talked a lot about basilica and I just wanted to re recap after careful thought, uh we elected not to perform a basilica procedure because we had low coronary heights, but very uh generous sinuses. And so basilica procedure was not performed. And uh I believe you are planning on assessing the hemodynamics to decide whether or not we need to do a about fracture after the valve is. So this is, this is honestly exactly what we were hoping for as far as very important to see the, the coronary. Um If we play that back, you can see, I hope the audience can see. We've got certainly low corner, we knew that they were below 10, they were around six, but we've got great selling despite this valve uh being in place. And, and again, if you really take the uh and make the valve coaxial here and not uh lined up to the surgical valves, we probably really are at four or five for depth. So we got plenty of room. What I love here is we have the time to think about this together debate. Blood pressure is 1 36/74 heart rate, 60. It is very easy and stable here. We're gonna release this case at 140 again. So for the final release, we also case again, not super rapidly but enough to be able to control. So at 140 Sarah is doing some work on the wire with without us even having to say it, she's done so many of these, but um she's centering the nose cone so that it's a more stable release by pulling the wire uh back it with the soft part into the nose cone but not letting that nose cone. The uh naked without a wire expanding nicely, the shoulders are coming out that looks really good. Perfect. And the key in that part is just to take your time. Let the night owl do its job, let it expand. We we you can back off Pacer. Very nice. So we talked about valve selection. We talked about the valve selection. One of the other benefits to this evolut is we can ensure that we didn't have coronary issues. Otherwise, if we were using a safety in here, it's as you guys know, it's 10 seconds blown up, uh valve deployed and then you deal with where the position is and you try, you can be very precise with that, but we recaptured this twice. Found the position we absolutely wanted were very precise within sub millimeter measurements of where we wanted to be. And we proved that we had corries before we actually deployed the valve. So it's incredibly powerful for, you know, I think even since the moment you deployed it, it looks like it further expanding into position and filling in that slot nicely. You gotta believe in the night. Now, believe in the night, I think that looks beautiful and for the folks at home that aren't able to see your hands, I just wanna emphasize what a coordinate effort that was to deploy that valve with everyone uh scrubbed at the table. You made it look easy. That, that, that's a, that I think that's a beautiful result there. It, it really is a nice co ordination. We, we tend to have more people in the room. We treat these a little bit like CTO S. We know that there's benefits if you can make it work from a group of having as many people involved in these procedures and more and more of uh so creating an environment where everyone can speak up. Um And so Katie, in the last case, uh asked for an echo, she's our stenographer and we got an echo and uh ensure that things were OK, but everyone in the room should have the freedom to, to speak up if they have concerns. Um And it does create an environment like we have here where there's coordinate efforts between multiple operators. Um And like Dave said, with the volume of experience, uh we're able to, to get good results and be very precise. So, Dave, I wonder if we can pull the audience based on how that looks and based on how our blood pressure is, what do you guys think the likelihood of us needing to post dilate our crack is we're gonna prove it one way or the other with human dynamics. But let's just call and see what people think. OK? Just, just to recap in case anyone had difficulty hearing. Doctor Kemp, we're, we're polling the audience predicting whether or not we're gonna need to uh do a, a valve fracture day for uh uh the nonstructural heart doctors on the watching. You want to explain to him what more specifically valve fracture is when we say FRAC or BVF, what we're talking about, you have quite a bit of experience with that case. So, so the, the, the question is, you know, the hemodynamics obviously are gonna be directly related to the, the size of the valve. And when we place a T or valve inside a surgical aortic valve, we are somewhat restricted by the size of that valve. And so, a common practice is actually to inflate a very noncom balloon within the surgical aortic valve to actually fracture the amul of that surgical aortic valve to enlarge it to uh to allow for the largest Valeria possible. And so, uh it's something that's rout. It's commonly done, I wouldn't say routinely. But in, you know, every case like this, uh we'll assess the human dynamics and if we feel like we can get a better uh hemodynamic result uh with, with bioprosthetic bowel fracture, that's a consideration. So, uh we're at that point right now with the case uh to make that decision. So Dave, you see those uh pressure wave forms, you wanna walk folks through that? Uh Yeah, they're small on my screen. I can't see the actual numbers but I can see that there is a gradient. Yeah, exactly. We've got a gradient of over 20 here. So I think it's important. It's not a benign thing to do a frack. Um Like we talked about earlier, we're, we're taking this to 300 P si to fracture an old surgical ring. And so I think it's really gradients that are elevated, we typically use over 15 or 20. Is that Fair Depot, right? And that, that makes so much sense. You see that the purple aortic curve does have a little bit of a a drop from the yellow LV curve and that, that great in as you saw is calculated out those that can see the screen, it's 21 millimeters of mercury. Um Not surprising, right? It was a smallish surgical valve to begin with. We got a valve inside a valve. And so the good news is we have a solution for that and we've planned for it and anticipated that. And most importantly, you saw we obviously deployed recaptured and redeployed. One of the reasons we were happy with that location is it sets us up to be able to do the frat more safely as opposed to if we were truly at zero, which could still be done. But obviously with more risk. It's a fro fracture. We typically use a true balloon that I want to talk about sizing of what you chose here. Yeah. So there's a lot of off uh out of the patient research bench research on this uh done by the folks that uh MidAmerica. But um what we're, what we're doing really here is, is using the dimensions of the surgical valve valve and what we know about the characteristics of that uh to expand the valve and fracture it. And we can actually reference uh how many atmospheres of pressure it generally takes for each valve. Um But what we do is take a Kevlar balloon and it's 22 millimeters. In this case, we go typically two above the true ID of the valve, which is the N ID. Um So it would typically be a 21 or the stent labeled size is 2021 as well in this with a 23 valve, we're kind of straddling between 23 and 21. Uh This is one of the valves that we need. Fracture may lead to a large and need for a larger valve if you do it up front. So we're gonna go with the 22 and then fracture it. Doctor Kemp mentioned checking the pace again. Can you hear? Yeah. So, so all of this is predicated on absolute rapid ta no PV, CS controlled and also the pressure going down. So Katie's gonna check our thresholds on the pacemaker just to make sure we're in the same place. Um The other thing is this is something where it takes multiple people to do this portion of the procedure. And if any one person isn't happy with the pacing, the capture the blood pressure, we say stop and the whole team stops. This tends to be a longer pacing run and Deepak is going to do the actual fracture part. It's a, it's a apparatus that we, we uh use and, and we can uh maybe show Deepak as he's doing. And if we're able to zoom in on that, that'd be great to show the audience how you set that up. Can we get our hand c and show that one section and then we'll want to see the screen when we actually do it, but just we can show our set up here. All right, let's pause there. So we can see the setup. This does require some coordinations and it's obviously a longer pacing and pacing them to zero like we would a balloon expandable valve. Um um It's a three way stop c this is the Kevlar balloon. Yes. What we do is take an inflator which allows us to go to very high atmospheres more than your hand can inject and we turn this off, but basically, we can preload the pressure into the side arm. Ok. So he's gonna preload that to 20 atmospheres or so. So that when he turns this stop top, all of that uh goes into the balloon. Ok. And we're gonna come up across and the sequence again, uh We are off basically to the inflator which allows a high pressure. We're gonna cross the valve and paste at rapid pressures to get the pressure to nothing. Epoch is then going to push as much contrast into the balloon as he can turn the stop clock towards him. So that all of that pressure and the inflator gets transmitted. He's gonna grab the end inflator and go up until the valve fractures and then he's gonna do that and reverse all within a matter of 10 seconds or so. Can you talk about visually what they might see and what you might be feeling in your hands when that happens? And you can feel in most cases, especially with this magna uh 3000, you can feel the valve um actually fracture with your hands. Some people claim that they can hear it, but I think that that's probably just their, their feeling in the hands. Um But it is a visual and tactile thing that you can see. And for those of you watching, I always find, I have to like keep my eyes glued to the screen looking to see that last second. When you see it just breaking fraction, you talk about balloon. Oh yeah. So you really want you don't, we, we do both before and after valve uh fracking fracking it's always safer to do it after and someone that isn't preconditioned to ARIC insufficiency. So, in other words, if the mode of degeneration of the bioprosthetic valve is A I, they're already experiencing that volume. And so we will typically frack before we, we do the, the valve implant. Um but most cases are stenosis and so we will do it after because they will be intolerant to the volume of acute A I. But in that strategy, you want to minimize how much you're touching the natural leaflets, the temps point. Uh We want to make sure that that proximal marker is right at the, the crown. Um And we've tested our pacemaker temps already all over that. We know that we're not going to lose, capture. The biggest risk of this is actually getting A PV C or losing capture and then that balloon can force the valve to embolize. So this is the most precarious part of this whole procedure. We're going to do it. Very coordinating everyone ready, ready a on 180. OK. That, all right. I'm going up with the first with the device now switching over and using the inter play. Uh uh mhm I basically, it did not fracture. We're gonna have to resuscitate a little bit. There we go. We put another one off, preload to higher this time. So we got expansion. Uh But you were up to 2425 the atmospheres, right? We're trying one more task. Let's take a look at the video. Just it definitely expanded, but I didn't see a fracture there un unless it is out of flame. I was intentionally a little bit distant with the balloon to stay away from the valve so we could start a little bit higher with that idea. Um We did have a 2025 millimeter gradient. So I think we do have to do this, you know, it stands a little bit. OK, Bob. Are you? OK. Uh I know that was a longer run. That looks pretty good though. And rhythms. We do it again. Yeah, right there. Paced around 180 ready have a lot balloon isn't gonna do it on this spot. It's coming down it down, they all pay her. Sometimes there can be enough scar tissue that it, it, it prevents the uh ball from going off. But I think we're, we've done two pretty long pacing runs. People are really intolerant to that and keep going. And so I know we've got expansion but let's uh up to then it's a Kevlar balloon. It won't rupture, but we, we supplied it looked like you were up to 28 atmospheres there. These valves are supposed to be off the can you uh go negative on that spot? Um And why don't we have Chris come and do an echo after those two pretty aggressive inflations. Chris is our uh excellent stenographer, sorry to back. So visually again, we got expansion. We will prove it with hemodynamics here, check with echo just to make sure nothing untoward happened that we can't see on the floor and we're not gonna fracture just a fracture and keep putting them through this. If the gradients look good, there's uh he, she's telling us that uh maybe she's got enough scar tissue around that, that we can't actually fracture the bowel and you know, it is typically a fracturing bowel. I think you at least got some modification if nothing else. Yeah, that's the other thing. Uh Even for valves that are not fractal like a trifecta, you can remodel them. So B prosthetic valve remodeling and you can actually get expansion even though the, the valve won't fracture. So there's merits to doing this. There's obviously risks too. Uh The multiple pacing runs were stopping this patient's heart every time we do that for an extended period of time. Um And then they have to be resuscitated. Um But you can also develop annular issues, rupture uh V sds, VSRS, those kind of things. So we're going to put a pig tail back in. It looks like we have no effusion on the echo. Um We don't have any PDL. We haven't done an aortogram just yet. Uh Other than that, it's 80% shot. We have a normal by the function actually, Bob with uh under Phil LV, just which is very normal after we unload a uh hypertrophy heart like this micro s good. We're good there. I think it's also important to realize who you can correct and who you shouldn't crack. So patients with ischemic heart disease, patients with lower efs aren't likely to tolerate these kind of pacing runs. We're, we're a little bit more insistent even in this one. I think after that first one, the reason we've had a higher gradient, but we also this is still a young patient that's got another valve in her, in her uh and her future beyond this one. Yeah, you can see that difference right? To remind folks, your, your, your gradient before your balloon was 21 I believe almost 22. Yep. And what are you getting? Now? You see you visually see the difference and it's down to officially it's measured at 15. Now we didn't clear all the lines. So I think that might actually be a little bit of an overestimate. Yeah, I mean, I can't see the numbers but looking at the tracings here, uh looks much better to me. The peak to peak here is 56, actually six is what we're and six is the mean we're getting now, measure good. Now we're gonna have Chris come back six single digit. The other important thing is obviously we measure directly in the procedure if we're going to do something differently. But clearly your patients aren't gonna get hard caps in the outpatient clinic. So it's very important that Chris is gonna get a baseline here. We'll get a baseline tomorrow and then a baseline at 30 days. So that's really what we're gonna compare if we don't necessarily want to compare apples to oranges. And again, I think anytime you leave the lab with a single digit gradient, you got to feel good about what you've achieved. Yeah, that's great. Nice job. Uh I would encourage questions from the audience now is a great time if you have any questions, uh just type them in and uh we'll uh relate this to the team. Be patient. What if you drop the 15, no a fusion? Um We wanna correlate, we obviously can't follow this patient long term and bring him to the Cath lab and measure trans prosthetic gradients every time. And so we're gonna use what we see on echo to, to monitor her going forward. What were you getting for gradients there, Chris? Yeah. It, it's low enough. It's certainly gonna be again, single digits. I think we're ready to close up shop here and while we're doing that, you guys can talk about uh um questions. I'm gonna take another aortogram real quick. We're uh we're waiting for questions to funnel in from the audience. You wanna um walk us through. What, what you do to finish up and close. That looks nice. Look at that good coronary. Fill both the coronary lighting up as doctor Summer said, you don't see any TV L this looks need of three by echo. 5 to 6 by K. That's a great result. Under 10 is normal. Yeah, that's very good to K point. Maybe it did actually fracture the plane. We just didn't see, I didn't feel anything but you don't always, certainly didn't hear anything. I heard him talking. Yeah, that's right. Yeah. So we did it, we did around 700 mantas when that first came out and had excellent results. We, we went through several different iterations like Dr Tara mentioned. Um we've done single per closes with one Andrew Seal. I think the manta gives us the capability to bail out if we do want to do hybrid closure with one on one. But with the new pros style, I think we've had so little issues once we trial that, that we, we've adopted the two the historically relevant two perpendicular floes, we're here. Now the pressure is OK. It's higher pace, but we're all right. Why? So we did it one oh, go ahead. Go ahead. Dave. It was about the rapid pacing. And I think this is an important point for uh for folks that are, are not doing this every day. You, you mentioned this, but I think it is worth restating. Uh The question was about the rapid pacing during your balloon inflation. And so uh you, you took a lot of care ensuring that your pacer was in good position and you had excellent capture before you, you, you did your rapid pacing and your balloon inflation and uh you made the point. But I think it's worth restating if that balloon migrates during inflation in this situation where you're inflating after your tabor valves implanted, that entire tabor valve will migrate with the balloon. And that's why rapid pacing is, is critical. And uh you took such such care to make sure everything was, was ready to go before you did that. Do you have any other comments on that? You know, that's, that's a perfect explanation, Dave, it's, it's, it's really about making that blood pressure the math next to nothing with the rapid pacing. We're trying to prevent any ejection from the, the native LV that would cause dislodgement of the tower or dislodgement of the balloon that would then dislodge. And it's really important that all team members are aware that obviously Doctor Trejo was working very hard to get that balloon up. He wasn't, you know, uh eyes on the screen looking at pressure where Doctor Summers and I could and at any time, if we didn't like it, we'd stop. Great team approach. And doctor is a powerlifter too so we can ensure that he gave us all of the uh effort there. Uh With the, the they let him skip arms tonight. Yeah. Yeah. Well, that's a great case. I would just to recap for anyone joining us late or, or with any questions. We uh we had a surgical aortic valve, a 21 millimeter valve. Uh We sized a 23 millimeter evolut self expanding valve. We assessed the the need for leaflet modification. Uh The patient had low coronary heights but very generous coronary sinuses and ultimately elected not to perform. Uh basilica leaflet modification uh proceeded nicely with the with a beautiful valve implantation a little bit on the low side. But uh that was by intent uh with anticipation of needing by prostate valve fracture, assessed human dynamics. Uh 21 millimeter gradient initially prior to the bowel fracture uh and felt that that was uh higher than uh desirable. Uh proceeded with uh a post dilation. I don't think you guys actually fractured, but uh you did expand the valve enough uh to improve the gradients down to single digits. And uh we just saw your clothes are shot there. Your, your angiogram showed that the coronary are wide open, paid with good flow. Uh uh post echocardiogram correlated with your invasive gradients and there was no effusion good by ventricular function. And uh your post uh angiogram showed uh an excellent closure of your large bore access. Great case everyone involved. That's a, a fantastic result. Thank you, Dave. We uh we, we do have uh the next, hey, Dave, the next uh 11 more thing we've got a, we've got a pacemaker in that uh the patient does have new conduction disease. So one of the risks uh it's lower in valve and valve tver is that we could induce complete heart block uh right after that second fracture, um we were pacing at 60 Dr Tara to turn it down to 50 the native rate came back. It looks like we've signed a bradycardia, but there is a new bundle. And so we have to make a decision on whether it's OK to send them up to the floor with an evolut valve, a self expanding valve that has a higher potential pacemaker rate without a backup pacemaker in place. One of the ways that we do that here is we simply take our uh pacemaker out and do an atrial pacing trial. Um And so we will try to conduct OK at 120 the 10 MA s. And basically, we're, it's a little stress test on the A V node. I'm not sure if he had contact me and sometimes can, can you do it a little slower first just to see if we're getting a capture at all and then we can go faster. Ok. Yeah, we're hooked up. But the basis. So sometimes the atrium doesn't capture after long pacing runs like that. There's a little bit of ischemia and I can't really tell if it's sinus or whether it's a different rhythm, it looks like sinus, but we're having trouble capturing. So as we're pacing, we're just not getting capture. So it's not a great case to demonstrate that, but you can turn up pacing. But typically, what we'll see is if we can conduct 1 to 1 without any detrimental conduction without any moments. Um Those patients have a very, very, very low pret test probability for needing um a definitive pacemaker afterwards. So we get confidence in that in this case. I mean, we have a new bundle. But what do you guys think about putting in a neckline? And um it's a valve and valve? I think the risk is probably yeah low risk. And so I would be comfortable saying no, I think the other thing I just want to point out is, you know, this was a teaching case. We were talking a lot as we went and we took some intentional pauses, but in less than an hour in a patient with previous surgery, severe a s high risk patient, which is part of the reason we're here, you've got now a new valve in in less than one hour skin to skin. Really, it's really remarkable where we are now what this technology allows with a gradient as, as Dr Adler pointed out and as we've discussed in the room, you know, less than 10 millimeters of mercury gradient, this hopefully gives us good durability, a great hemodynamic result. No pacemaker. We don't think at this stage and uh this patient will be awake and asking for lunch soon. Uh I think Dr Pe, right. Do we have any questions, Dave? I think you, you address all the questions you had from the audience. There's a lot of different practice that use all the same and things. But it's variations in practice while we're waiting for questions. I'll just also point out you saw the, the great coordinations in the room. We're very fortunate to have a tremendous team here. Our, our cath lab teams, echo teams, anesthesia, our A PPS that, that help with from work up to valve implant. We're very blessed. We are all right. We are finished. Successful case. Um There's no other questions we'll, we'll stop there. Is that fair?
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