Dr. Kemp & Dr. Summers describes a patient's personal journey through treatment for aortic stenosis and the management of his care by Sentara's Heart Valve Center.
Thank you all very much for joining us, uh, here in the room and for those, uh, who are online on teams. Uh, Doctor Summers and I have a fantastic grand rounds for you that I think really highlights, uh, the work that everyone here in this hospital is doing, um, at the valve Center, not just the cardiologists, not just the surgeons, not just the anesthesiologists or intensivists, but literally everybody in this building. Um, we're really pleased and proud to have, uh, one of our patients, Doctor O'Neill, who was very nice enough, uh, to come in and, uh, participate in this grand rounds. And really the first part of the story is all about how all of you in this building have gotten him to where he is now. And then hopefully, as Dr. Summers is going to explain, um, with our dossi, you know, how we plan out the next 10 years and beyond. So the title of this lecture is Taver quote unquote versus Saver, and we did that sort of tongue in cheek because I think in a lot of places, a lot of major places in cardiac surgery and cardiology, that's still what this is. It's really a competition. There is sort of infighting and things like that, but I think at the more sophisticated centers like ours, we're really truly trying to figure out what's going to be best for the patient, not what's going to be best for our own personal interests. So, because we're going to talk about some serious things, I thought I'd lighten it up a little bit and we're going to talk about a play in 3 acts. Um, the first part is S Saver and Taver, and then potentially and Taver again, one patient's personal journey, and that's Doctor O'Neill's. We're going to talk about a play in 3 acts, um, Saver and Tver and potentially another Tavern and beyond one patient's personal journey, how AI helps determine optimal lifetime management and really plans for our TAVRs. And then finally, who should get SAR in 2026. So Act one, it's really truly, it takes a village and it was impossible to put absolutely everybody who was involved in Doctor O'Neill's care in here. So just know if you weren't mentioned by name, it's not that you weren't part of it. It really, truly did take everybody on all service lines to do this. So all of you here know what these slides are. Dr. O'Neill doesn't, but this is how we present patients in structural heart clinic, and this is actually the older process before we purposely redesigned it about 3 years ago. But essentially all of this work is done by both. Teams by surgery and by structural heart. And these slides are put together by Sarah Kennedy. I'm gonna call her out nicely because she's in the front there and her colleagues and really provide all of the data that we need from months of workup to be able to make decisions about patients, OK? 70 year old who had had a prior uh Bentyl with a Medtronic Freestyle aortic root by Doctor Barnhart here in this hospital in 2004, although I suppose that was Norfolk General, not the Heart Hospital, but still our service line. Eventually, as all biologic valves do, this one failed. Unfortunately with the Medtronic freestyles, although they get fantastic hemodynamics, their mechanism of failure is severe calcification. And so he was seen by two of my partners and due to the extreme calcification in his root, was deemed much better served with a Tver inside the salver rather than a reduced sternotomy. Interestingly, when you just look at STS risk of mortality, 3.3% puts him right at the borderline of low to intermediate risk, and if you just went by the numbers, he should and could have gotten a reduced otomy. However, with that calcification, it was nearly prohibitive, if not prohibitive. Normal EKG. Coronaries looked good. And here's what his valve looked like. So as with many of these valves, he had degeneration from AI, OK. Based on his aortic valve assessment, we measured him up for a TAVR. He had excellent peripheral access. And this is what we go through for all the patients at Catavers, not just valve and valve, but even native annuli. All of these measurements are done by the APP team and cross-checked by us so that we can plan this out. And we had that plan, right? We had a pattern plan for a 29 e loop. Unfortunately, the best laid plans. We had planned for an outpatient sort of elective-ish caver. However, he was admitted on July 4th weekend with ADHF, the worst possible time on a holiday weekend. I happened to be the surgeon on call. I think it was my 2nd year, and I didn't know Doctor O'Neil yet, but when he came in with AI and he had had a prior surgical valve, before looking at the chart, I thought, great, well, he's a candidate. It's unfortunate we have to do an urgent reduce sternotomy, but we're going to do it. Did a little bit more digging in the chart and one of my senior most partners had decided he was inoperable and I didn't disagree with him. And so I called Paul Mahoney, who was in charge of the program at that time, and on a July 4th weekend, he came in, we mobilized the team, the cath lab, the OR, industry support to help support this case, and to my knowledge, this was the first after hours inpatient urgent taver that we had done, and it went fantastic. And I thank Dr. Summers for putting together these slides to show this valve and valve. So what you see on the left there in that video is the start of deployment. This is an evolut, and we're putting it inside of the Medtronic Freestyle. So using all of that calcium to our advantage to be able to anchor this valve. Why is that? We're happy with our depth there. The valve is already starting to work. And here's our completion shot. This is a pretty standard valve and valve picture that we see. And Amy, do you know why this is auto advancing? Something on the side. OK. Um, he was discharged on post-op day 4, and I went through all of the notes, and one of the subjectives from somebody who saw Doctor O'Neill said that he felt remarkably better. Those were the exact words. And he was doing very well as an outpatient from 2019 to 2022. He was followed by other people, Doctor Gentlik and Doctor Bernstein, and EP for atrial fibrillation and for a pacemaker. Uh, he had seen Doctor Hurry in the heart failure clinic for long-standing heart failure in an aortic clinic with Doctor Barrero because despite having had his first operation, he did have a mild aneurysm that had been stable and certainly had not met criteria for intervention. However, things changed in November of 2022. He had acute onset of chest and back pain, and sure enough, yours truly happened to be on call that day. And for those that don't understand the aortic alert system, when a patient is diagnosed with an aortic dissection in our system or outside, we get a page with the patient's name, where they are, and what it is. And I have to admit, Doctor O'Neill, it had been a couple of years since I had seen you, but I knew that name was familiar. And as soon as I looked that up. I wasn't so much worried about having to do a reduced sternotomy, uh, aortic dissection, although I would have appreciated not being on Eliquis, but I understand why you're on that. Um, what really worried me was we may have to do something about this valve, and that was the whole reason that we did a TAVR in the first place. And so here's his CT scan, and it's exactly as you'd expect. It's pretty classic for a type A, aortic dissection. He has multiple tears in his ascending. You can see one and two there. Uh And then as you go down into the descending, as with most of these dissections, this continues all the way down into the iliacs. If we look at it in the axial is very similar, you can see the evolute valve that's there in place. In the true lumen, there's one tear. There's another tear. And then going on. So we had extensive discussions. This is, you know, one of the most well educated patients who understands what's going on with them, has been through a lot, certainly been through the system, no stranger to the heart hospital. And it was also during a time where another family member was also having a medical issue. So it was very, very difficult discussions and, you know, we were frank. This was an operation where if we didn't do anything, nearly uniform fatality, if we did something and we had to do something about that route, could be very similar despite all of our best efforts if he had something that was reconstructible. So in the end, we went to the operating room for urgent repair. And I've been I've never been happier than when Doctor McLeish, who was there at the time, told me that evolut's working beautifully, OK, working beautifully. So, 3 years later, working beautifully. Um, as I mentioned, he was on Eliquis, so very, very bloody, um, redo sternotomy, did an ascending hemi arch with deep hypothermic circulatory rest, and were able to spare the root. Despite all of this and an open chest initially, he was discharged on post-op day 13. And here's his completion CT scan. You can see the evolute in place, my graft going up to the arch, and as expected, a persistent dissection in the descending, which is something that for those who don't staff the aortic clinic, we follow these and see if they degenerate or get bigger or have any malperfusion, but most patients like this can live with it for the rest of their lives. Only 20% of patients need another intervention. So he was followed and joined aortic clinic. I involved Doctor Dexter for the descending component. He was followed instructural heart clinic with Doctor Summers and Doctor Cohen, and he was still followed in the heart failure clinic with Doctor Hurry. Unfortunately, over this time, he had worsening heart failure symptoms and his EF dropped to about 40. He was then seen back in the EP clinic with Doctor Keel, and he was concerned for pacing induced cardiomyopathy. He had a pacemaker since his first operation in 2004. And so in July of 2025, he underwent a lead extraction and an upgrade to a CRTD. Although we were on standby for Dr. Keel, he was able to do that, get Dr. O'Neill through this. However, despite this, still 56 months later, he had worsening heart failure symptoms, and we found the true reason for why he had heart failure, and that was bioprosthetic valve dysfunction in his evolute valve, which at this point was 7 years old, valve and valve. This is kind of end of line for that valve. So at this point, I'm going to turn it over to Dr. Summers and for those Stanley Kubrick fans, this is Act 2, Dossy, or How I Learned to Stop Worrying and Love AI. And Matt's going to be too modest about this, but this is a technology that not everybody has, and Matt and. Frankly, the residents and his team got in on the ground with this company before it was even out there and allowed our patients like Dr. O'Neill and those that we're screening today to have access to this technology which is going to revolutionize how we do Tr and frankly Savr in the future. Yeah. So I appreciate the chance to, uh, like, like in this example, uh, come in, uh, more in the tail end of, of, uh, this wonderful gentleman's care, um, and be a part of really what I think demonstrates. Start to finish the entirety of our capabilities at the heart hospital. It's not common, coming from a big surgical group in training to take a patient with a pretty severe aortic valve problem in 2004, do a complex Bental procedure, get that patient 14 years with that result, which is really incredible surgical result, and then when he comes in on a weekend. Uh, what, what maybe wasn't as highlighted as much as how sick he probably was, this was before my time here in 2018, but when a prosthetic valve, uh, experiences regurgitation, the, the LVA is preconditioned for stenosis in most scenarios. That's, that's how they, they got the, uh, aortic valve replacement in the first place. And so from coming in at the tail end of this gentleman's care and reading through the notes, it sounds like on the July 4th weekend he was incredibly sick. What's in our run of the mill heart failure. It's something that required, I think, Mahoney to come back from the Outer Banks and you guys to mobilize the entire team to do an emergent taver. And and the one thing that that I should have highlighted a little bit more on those slides was how many recaptures there were, and that wasn't because it was difficult to put the valve in. It was because there was an eye towards he was only 72 at the time, 73 at the time. They were trying to intentionally, since he already had a pacemaker, get a 6 to 8 millimeter implant depth so that we would have future options. So even in the throes of an emergency with the amount of planning that's been done at this program historically and the amount of collaboration with the surgeons, there was a combined effort to make sure that he had future options, and I get to come in at the end of that when those future options are needed and apply some new technology that allows us to again safeguard those future options even further. The fact that he can come in after that, you know, 7 years after that with an acute dissection previously inoperable on a DA. Um, and get through that operation is a testament to the, the surgical therapies that we're capable of here. It's why my family's moved to the area. It's why I have confidence that my neighbors, my family, you know, members, my friends, if they have even the most extreme cardiac problems, uh, they can walk in through the front door of this hospital and the people in this room and the people on our teams can take care of them and, and certainly an acute aortic dissection. Uh, after a valve and valve tavern, someone that, that, uh, would need a redo on anticoagulation is, is incredible. Um. We talked about this in grand rounds last year, but, uh, this case also highlights the change in how we've, we've prepared for complex procedures and safeguarded people's future options. Um, you'll notice on those initial planning slides that Sarah and RIPPs put together back in 2018 that we were using a lot of TEE measurements. Um, we were using a lot of CT, uh, measurements, and this is morphed from 2010 to where we're at currently. People were doing 3D printing. We were doing that as well, and then we started incorporating in 2022, virtual or static 3D prints, which allows you to embed virtual geometry on top of CT scans. But as you notice in that valve and Mack case we did, the calcium protrudes through the stent, and so it doesn't really account for tissue deformation. Um, that static modeling we used for complex mitral cases and it left a little bit to be desired as far as the precision. And Doctor Cohen, even before, uh, uh, he was officially signed on here and I were looking for ways to, to do better with that and uh had met with this company, this new company, DA that allows for computational dynamic 3D modeling. All the complications from TAVR coronary occlusion, annular rupture, um, PVL, uh, pacemaker even. are related to a stent deforming native anatomy, and, and that anatomy can be very unique. An aortic valve is much like a fingerprint, and so the complexity of it is much more than just drawing a circle on top of a CT scan, and we needed something better. And so, uh, as Doctor Kemp mentioned, we, we sort of got in at the ground level with this very small company and have used them in over 300 cases now to, to help safeguard people's future options, but also. Make sure that we're doing the procedure in real time with an eye towards those future options, trying to mitigate all the risk that comes inherently with putting a valve into unique anatomy. So this is how we approach things now. So he showed the, the 2018 planning. Um, the program has grown, the complexity has grown. Um, we're talking about valve and valve and valve and valve and valves, uh, in 77 year olds, and, uh, and, and with that comes, and we just had our valve conference yesterday. Every single case is, is becoming more and more complex and so we have to have a way to review those collaboratively with, with all the surgeons in the room, with all the interventional cardiologists in the room, uh, and come to a consensus on how to manage these patients. And so this was really more from what we were doing in Cleveland, but it distills all the important. Clinical points, imaging points, uh, anatomical points to make a decision, not just on quote unquote versus SAR, but on what aortic valve therapy individual patients need with an eye again towards mitigating risk during that procedure, but also making sure we safeguard future options. And this is how we're doing the modeling now. And so I, I showed this at grand rounds last, uh, I think it was in October, um, but this is, this is a real patient, a 72 year old bicuspid that we're making a decision about a sapien versus nevolute. And, and as you can see, this allows us to determine implant depth and see what tissue deformation does in response, um, to that anatomy. This is uh the app that they've developed. And you know that you can only have so much of a crystal ball that still complications can happen, but I would, I would argue that. We anticipate them a lot better now, having had one yesterday that Doctor Scortino miraculously salvaged. This doesn't look up at the aorta as much. It's really focused on the annulus, so TAVR is still something in 2026 that has a 1 in 500 risk of of fatality or conversion open surgery. But again, when our surgeons can take care of. Uh, acute dissections and post-TR patients 5 years out that were previously considered inoperable on anticoagulation, um, that gives us the capabilities to not just say no to more complex patients, but to, to really, uh, look for opportunities to, to try to help people from, uh, problems that really don't have any other solutions. And so I think that's really one of the ways that we're unique here. This is what the lifetime management uh uh planning looks like. And so, uh, AI has developed these um. Coronary occlusion risks, but what it allows us to do is put in an initial valve and look at every single iteration of a redo tabber. And with that, um, when we talk about putting a new tabber inside of a tall frame valve, like an evolut, as Doctor O'Neill's scenario, we're talking about which node to implant at. When the valve has a primary mode of degeneration, we can implant at node 3 or node 4. When the valve has a stenotic substrate, we're generally implanting at node 5 or node 6, and, and the reason that's important is you can have a balance of tissue, leaflet overhang from the evolute since it's super annular. So you want to cover as much of that as you can, but you also don't want to include the coronaries in the superannular valve that the anatomy gets very, very risky. So the coronary risk plane is something we talk about. And the, the single greatest reason that we don't have feasibility for a redo tavern, again, that's a big deal because we offered someone a minimally invasive option when in large part for low-risk patients, they could have gotten surgery. So if we make that decision wrong, 10 years, 15 years, they're older, they're definitely higher risk, usually in their late 70s or 80s. Um, if we don't have that feasibility safeguarded. Then we're telling them no, or they have to go through an eggplant which even in the best hands can have 10 to 15% mortality rate. Ours is much better here, but it's a big deal to to to guess wrong, so to speak, and we really use modeling in the highest levels to make sure that we guess wrong, much, much, much less often. Even though we can't necessarily predict the future, we can do everything in our power to use the best available tools to plan for it. And so this is an example of how we're looking at patients that are younger, uh, where we have both great surgical options and trans catheter options, trying to individualize care, but not talking about just the procedure that we're embarking on, but talking about the next procedure if that person outlives their valve. So back to our patient, and then I'll turn it back over to Doctor Kemp. When we look at uh uh this gentleman. In current day, uh, we see that dissection that Doctor Kemp was talking about, pretty miraculous recovery and durability, 7 to 8 years out of a valve and valve is, is pretty reasonable, especially with the aortic disease and everything that transpired. But one of the things when I, I came in later, I came in at this point to try to see if we had feasibility of another valve, um, that I noticed is even back in 2018 with the, the sophistication of this program before I was here. Um, there was an eye towards these kind of things, and you can see that in the initial implant depth during that emergency procedure. One of the things you notice here is that with the freestyle route, there's capacious sinuses. The coronary risk plane is such that we have plenty of height to the coronary. The leaflets you can see here. Actually a flail leaflet on the, the bioprosthetic valve. Um, and so really the question came up is, you know, it's class 2, almost class 3 symptoms. Can we do another TAVR? And then he's still only 77 years old. So, uh, where are we going to implant this TAVR? Um, can we be as good as, uh, Kemp and Mahoney were in 2018 and, and do a procedure that sets us up towards, you know, uh, you know, 2040. So this is the modeling from this case. You can see we found very, very precisely on the CT scan a torn right equivalent bioprosthetic coronary leaflet. When we look at which nodes of implant, we modeled a node 4 and a node 5 implant, um, the risks of coronary occlusion. Um, if we put another evolute inside, and this is our eye towards what we'll do in 15 years, we still have feasibility. It's borderline, but we have, uh, open coronary so that we could do a sapient and then an evolute, uh, if, if, uh, if we have that opportunity to help again in, in 10 to 15 years. It shows us implanting a 26 at node 5. It shows what the tissue around the valve looks like. It shows us where coronary, coronary flow can be maintained. It shows us exactly how coronaries fill from the sinuses. You can see the ostom of the coronary with an implanted valve on top of, on top of that, uh, this is the sapient here at node 5. So even with a higher implant, um, we have safeguarded coronary occlusion, which is largely one of the biggest reasons we don't have, uh, redo feasibility. I'm looking at this with, uh, a balloon expandable 26 at node 5, the, the, the right coronary is also OK. We look at position, where, where we have leaks. And so this is highly specific in us determining where PVL will happen because it can model the precision of stent expansion in unique anatomy. If we put a SEV inside, so if we did an evolute and evolute, which we don't do, uh, yet, but we will in, uh, in the future, um, we also have safeguarded anatomy that allows for maintaining sinus and coronary perfusion. There's some borderline, uh, features here. It highlights the importance of commercial alignment. Uh, this is a commercial tab. This is looking into the right corner. And so one of the new features of, of the evoluts that that they didn't have back in 2018 was commercial alignment. Somehow you guys still ended up perfectly commercially aligned without that technology and an evolut R in 2018. But we've basically shown that we can deploy a valve now, uh, again, 3rd valve, and that we also, depending on The implantation depth would have options for another valve, and uh. And that's what we ended up doing. And you can see this is Doctor Kemp and I implanting the valve exactly at node 4, which is what we had planned based on that modeling. So that again, in 2040, hopefully longer than that, uh, we get the opportunity to help again. He ended up in spite of a valve in valve in valve having no PDL and a mean grading of 3. With that, I'll turn it back over to Doctor Kim. I can't tell you how good I felt when I called Dr. O'Neill a couple of weeks ago and told him we were planning this and asked him how he was doing, and he went from not being able to really go around the house without being short of breath to, hey, I'm walking 2.5 miles now. I just went to the Southwest with my family, and although the elevation was higher, I was still getting around and doing those things, and that's, that's honestly what I think sometimes everybody here can forget about, not because they want to or because they do, but because we're working so. Hard for this, but you know, at the end of the day, the reason we do this is for our patients, and I'm not just saying that because Doctor O'Neill and his wife are here. We all know that about all our patients, but that's why we do what we do, and I don't think it's been done before, a valve and valve and valve and valve and valve, but as Matt very nicely pointed out, based on the planning and and honestly based on the foresight that Dr. Mahoney had earlier, we have that possibility, and that's what we provide to all of the patients who come through the valve center and. It's difficult sometimes because the patients obviously want to be taken care of right now. They want their problem dealt with, their symptoms alleviated, their risks of mortality gone away, but it's important for them to understand all of these thought processes that go on behind the scenes, um, much of which this honestly is not reimbursable. It's not done at other hospitals, but we do it because we know it's the right thing for the patients and to be able to set themselves up for success in the future. So with that, we'll go to the last part of the talk, and this is a quote that was delivered by my partner here, Doctor Summers. Not everybody wants a sternotomy, but some people need one, right? So this is really who shouldn't get a TAVR or who should get a SAR, and I have to be honest, I gave this talk at the STS and so it was in front of an entirely surgical audience. So that's why it's who shouldn't get a TAVR, but it's really who should get a SAR in 2026 when anatomy trumps patient preference. So who shouldn't get a TR? Who should get SAR? Young patients, I put in question mark because as Matt very nicely mentioned, all of these treatments are unique. I'm still trying to work with some lawyers to get the concept of bespoke valve replacement patented and trademarked so nobody else can use it. But that's essentially what our teams do is we try to figure out what's going to be the best valve replacement for each patient, regardless of age, regardless of other comorbidities. Um, sometimes people need a high risk surgery. Sometimes otherwise younger patients need a TAR as part of their lifetime planning. Things that make sense are life expectancy less than a year. Annulus outside of the instructions for use for a TR valve. We don't want, we don't want embolizations. We don't want root ruptures. Hostile root or annulus, same thing, prohibitive access. We've got to get this valve in here, polyvalvular disease. There are some patients who get multiple percutaneous options, but that's only after we've exhausted all the possibilities for multi-valve surgery. Aortopathy and arrange for treatment, treat everything at once, even if it means surgery, and then concomitant surgical grade coronary disease. But what do we forget with this sometimes? Well, and, and that's anatomy, right? So there are a couple of things that we look at that really can sway us towards surgery. One is a predicted patient prosthesis mismatch with need for root enlargement. Um, starting in 2018 when a landmark paper came out of Columbia. Demonstrating that there were real differences between the hemodynamics and the EOA or how large the valves were between the two commercially available platforms. This really was an aha moment for the field, and I'm glad that we embraced it here and we started taking a look at hemodynamics and EOA and TAVR. And this is interesting because hemodynamics and EOAs have always been a part of surgical aortic valve replacement. It's something every surgeon learns in fellowship and practices. And TR at that point in 2018 was still going from, can we do it? Can we do it safely? Should we do it? Who should we do it in, to starting to get more sophisticated. And I'm proud to say that our program really kind of led that way along with others to get out the human dynamic message. Bicuspid aortic valves have always been sort of the question, can we treat bicuspid aortic valves with TAVR? Does every bicuspid need to have a SAR? And then a previous TAVR without commissure alignment. This is something where we're all sort of paying the price for the fact that we didn't have commissal alignment in the past. Now we do with certain platforms and especially in younger patients. Making sure that we implant correctly today in 2026 directly impacts what we're going to do in 2036 and beyond, and it behooves all of us to learn from these messages. So I'll go through three examples that have come through valve clinic. Um, so case one is a small annulus with a predicted PPM, OK? This is a 58-year-old with severe AS, tricuspid valve, despite being 58, hypertension, left bundle branch block, presented with classic symptoms, dyspnea and exercise intolerance. Normal function, severe AS, met all the criteria. So when you look, you see that the area is 326 and just to give everybody a frame of reference, we had a landmark small annulist trial published several years ago, and the definition of small annulus in that trial was an area less than 430. So this is even smaller than that, right? So this slide that was put together that you've seen examples of has all the comorbidities, has access, has annular planes, but everything comes down to that box on the right where you see the two yellows. And this is where centers like ours that take these things into account really do shine because at a lot of other places, this patient would have gotten a TAVR. I think they would have done very well initially, certainly gotten through the operation with low STS risk and everything like that. But yellow means moderate patient prosthesis mismatch. It's important to know that any time you put a valve in, be it surgical or TAVR, the valve you put in is going to be smaller than the patient's native valve, and you don't want to trade severe aortic stenosis essentially for moderate aortic stenosis. And before that landmark paper in 2018 came out, that's what all of us were doing because we didn't have that data. Now armed with this data. And the fact that our surgical team is performing root enlargements and root replacements, that's exactly what she got. She got a 23 millimeter onyx with a reverse Y root enlargement, and I actually have to give credit to my partner, Dr. Pienta, who came from Michigan where the reverse Y was engineered and developed, who came in and gave me tips and tricks from the master himself, Bo Yang, and that patient did fantastic. So case number 2, a true Sever zero bicuspid valve. Um, I get asked, as I'm sure Dr. Summers does too, you know, can we treat bicuspids with TAVR? And my, my true sense is yes, we can, but much as he mentioned that all aortic valves are like fingerprints, they're unique, it depends on the anatomy. A Cs type 1 or a Cs type 2, which is truly a fused tricuspid, I really do believe can be treated with TAVR. Some. Type 0 can, but we've learned from experience over time that with the irregular annuli of a Cs type 0, they're really set up for two potential issues. One of them is root rupture, which is nearly uniformly fatal, and the other is PVL, which isn't fatal, but it's trading aortic stenosis for aortic regurgitation, which, as those with aortic regurgitation can tell you, is just about as miserable as AS. So this is a 76-year-old gentleman. Severe AS in the setting of a bicuspid valve. Some coronary disease fixed in 2015, patent coronaries now. The rest of the comorbidities as to be expected, presented with worsening dyspnea on exertion. So he had normal function, severe AS, and criteria that met gradients that met criteria, and a very, very, very heavily calcified valve. So here is the opposite scenario, right? So this is a scenario where we actually modeled all three commercially available valves, right? Whether we used an Evolut, a sapient, or a Naviator, these were fantastic in terms of the EOAs. I will point out one. The is just 0.02 away from moderate PPM, so we would have likely shied away from that one, but we had two good options for this patient who's 76, right, who would be TAVR in a lot of other places. We had great options for TAVR for this gentleman. However, there's more. So I get asked, you know, is it mostly from my family who I think still just can't understand that I'm a doctor and not, you know, the toddler running around the house anymore, you know, are, are we going to lose all our jobs to AI? Is AI going to replace us? And I think Jensen Wong, the CEO of Nvidia, put it best. You're not going to lose your job to AI, but you're going to lose your job to somebody who uses AI, right? People who don't adopt technology like Dsy, plenty of other examples in other fields and in other industries, but that's really sort of the wave of the future. So Matt sent this off to Dassey, and here's what we got, and I think of Dassey kind of like Siri. I asked Siri to do something. We asked Dassey to do something. So Dassey, can you model us PVL risk and annular rupture risk with a balloon expandable and a self-expanding platform? And that's what he she slash they did. So we took a look at the two valves that would have been sized, right? So a 29 sapien balloon expandable or a 34 evolute, and the two things we were looking for was PVL and then stretch analysis or root rupture risk. Without getting too technical, it's really the balloon expandable valves that are our biggest risk for root rupture. And what you see is that this gives us a prediction of a max stretch of 1.9. For frame of reference, anything more than 1.5 is considered high risk for root rupture. So right away, without even thinking anymore, we have a model here who's predicting, don't use the balloon expandable valve. OK, great. So we'll use a self-expanding valve that doesn't have the root rupture risk. What we ask for that one is, what are the risks for PVL? Well, the largest gap there is 2.5 millimeters in the relative space of the root. That's like driving a truck through there. That's a huge, huge, huge gap. So while we would cure the AS, we would absolutely leave the patient with AI, which frankly is no better. So going through the scenarios, and this is actually what I did when the patient came back. So the way this typically transpires is patients will see Dr. Summers or his colleagues will see myself and my colleagues. They'll come to our valve conference every Monday morning where because of the efficiencies, because of what the APPs can put together, because we have all the interested parties, we have 25 patients, I think the last time that we get through in a morning, not to mention the mit. And tricuspid patients and then sometimes we have to go back and change gears. So this is one where both Doctor Summers and I said we're going to send it to DAy if all things are equal, TAVR is certainly reasonable. That's what we'll do. The reason we do it is it's safer, it's less invasive, it's low risk. But if DASy tells us that it's going to be either unsafe to do the TAVR or it's going to leave you with a result that's not perfect because you're certainly not inoperable, we may change gears. Well, I can't imagine. Any patients excited to hear, hold on, we're going to have to re-talk about surgery. But you know what I did? I actually got this presentation from Matt and I showed the patient this. I said this is the level of detail that everybody in our valve center does for all of the patients. And again, he wasn't excited to hear he needed surgery, but knowing that we went to this level of detail to plan this out, he knew it was the best thought out plan, and he knew that was going to work. So just taking a look at the coronaries again, he had capacious coronaries, so we weren't worried at all about coronary risk. Here's where we started to get worried. So opposition for PVL, even with the balloon expandable valve, which to be honest, before these modeling programs, the mantra out there was, well, we can just add more to this balloon and we can conform to this annulus and get rid of all those leaks. That's just not true. I mean, that's what's shown here in this. Stretch analysis and potentially or in particular rather we talked about anything more than 1.5 being a root rupture risk. This patient would be at severe risk for root rupture, and I'll be honest, before Dossey, this patient may have gotten, uh, may have gotten a 29 sapient and not that there's anything wrong with that, we just didn't have that information, but it's, you know, not feasible to not use the information we have now to best plan these out. So let's take a look at the self-expanding again. Before Dassey, we might have said, well, you know what, we can use a self-expanding because that night owl is going to take up all those nooks and crannies, and we're going to do this. And again, you see the animations. Coronaries, no issues, risks whatsoever. However, still going to have significant gaps, right? So this is exactly how we decided we were going to do surgery. So in valve conference, we recommended Saver. Got a 27 millimeter valve in there, and this is where I'm proud of my partners for putting in the biggest valves they can appropriately, doing root enlargements, root replacements when necessary, because I want to set this gentleman up to be able to have a tavern and salver 10 years down the line. And to be quite honest, he can have a tav and t and salve based on this setup. And if there was any question in my mind that AI didn't work or that this program was neat, but it didn't really show what we needed to do. When I did this case, I first saw surgeon's view of that valve, right? And in my mind I said that looks an awful lot, awful lot like the dossi would have predicted, right? And what I did when I was finished with the case was I put these up together and sure enough, exactly what Dossey predicted was exactly what I was seeing. Even the calcium patterns were exactly the same. This is an incredibly powerful tool. I'm thankful that Medtronic has partnered with Dassey to be able to get this out there. It's a small company. We got in on the ground layer on the ground. You know, their first rollout, and I'm happy to be able to use this for our patients, and this patient got an excellent result, so we took him from a bicuspid calcified valve to a beautiful valve, bioprosthetic valve that's going to last him and it's going to plan for the future. So then finally, we'll talk about TAVR without commercial alignment. So this was an inpatient consult I got. 71-year-old gentleman had an Evolut 34. It's important to note that it's an Evolut R. So this is in 2021. Um, he has lupus. He had a renal transplant secondary to the lupus, kidney with a creatinine of 2.0, so not working perfectly. STS risk of mortality at 9%, so he's in the high risk category. He actually was admitted with COVID pneumonia and was thought initially just to have dyspnea from that until workup realized that he actually had transvalvular AI, so he had bioprosthetic valve dysfunction in this valve. And we initially took a look at the CAT scan and then sent it to Dsy, and I was hoping, hoping that this patient could be a TAVR valve and valve, because this is exactly what TAVR was meant for high risk patients who need something and you know, shouldn't necessarily have to get surgery. And I knew when the DAy came back and Doctor Summers was calling me, he wasn't calling me to tell me that we were going to put this on for Monday. He was calling to tell me what we had feared, and that's we didn't have commissure alignment. So unfortunately our commissures were those posts were right in front of the coronaries. So despite all of the technology we have, it's beyond the scope of this lecture, but he's brought in some technology for leaflet modification so that we can take care of difficult valve anatomies. This is something where the only way to take it out is going to be with surgery. Just taking a look, um, you can see the ones in red no matter what valve we put, and that's the, that's the advantage of dossier is we can plan out multiple different valves. All of them were in the red for coronary sequestration, and so we essentially couldn't do it. So we had to do a SAR, right? So there's a patient who had just gotten over COVID on a good day, and to be quite honest, it didn't take that into account. So his STS was probably over 10. On a good day, his STS was 9. He needed a TAVR explant. He got a 25 millimeter Epic Max, and I'm just going to show you a little bit about our Tavax plants, and I will brag on the surgical program now for a minute. Um, Tavax plants are the fastest growing surgical procedure that's out there, OK? Really large centers like. Michigan, Cedars-Sinai have done, you know, maybe 100 of these, 150. We've done nearly 50 in our program, which I think is fantastic, and we're in the process of writing all of this up. Our results are fantastic and comparable to any of those programs, which is great. But one of the things that we've done is kind of refined the technique. So these are intraoperative pictures of sort of how we do it. Picture on the left is the surgeon's view of the aorta, and what's challenging in particular about the evolute valves is they're taller framed valves. And so if you're looking at this picture as a non-surgeon, the head is up to the left, the feet are down to the right, Essentially where that top blue line is, the one to the furthest left, that's the extent of the evolute basket. And that other line there is where we make our incision in the aorta to get the evolute out. Now, why traditionally it's been difficult to take evolutes out is because it's a larger valve. With careful technique, we're able to actually free up that evolute from the aorta, and then if you move over to the picture on the right, we have that basket completely delivered out. And then here's a technique I actually learned, and Doctor Barrero will appreciate this. John Victor Conte is the one who showed me this technique, and that's remembering the properties of the valve itself. So it's made out of nightanol, and when we squirt it with cold saline, that nightanol pulls away. And you can see that I could pull this out with my pickups. I didn't because I wanted to demonstrate how to do the resheathing technique, but this is something where just thinking about the properties of the valve itself, and this isn't something, by the way, the valve company or industry came up with. This is what surgeons came up with, and this was circa, you know, 2012, 2013, just because we were faced with a case we had to do it. And Conti, my mentor, said, you know what, let's give it a try. It can't hurt. Turns out that's the way to do it. Then we put some sutures in and we actually just re-sheath the valve, and by re-sheathing the valve and taking it out safely, we can do this and reduce the need for concomitant operations. So one of the reasons why, as Dr. Summers mentioned, historically the mortality for a Trexplantt has been up to 20%. is because people were getting the TAR valve out along with the mitral valve or along with the aorta mitral curtain or along with the aorta, and with this we've gotten our concomitant need for procedure rate incredibly down and made the procedure almost as safe as just a straightforward AVR. So in summary, Saver and Taver, and I think we've showed you how with careful planning, we can potentially even get Doctor O'Neil one more Taver, and that's his personal journey. And I'm really, really proud and glad that he and his wife decided to join us today. Um, we probably could have called multiple different Patients. I love Doctor O'Neill and I'm glad he came. And this is honestly, sir, probably the most, um, not extreme, but most incredible journey. We've had plenty of patients who've had valve and valve, but you know, to really go from 2004 till now and then have plans for the future, that's why we do what we do. Um, AI, it's not going to take over your job. It is the future and thankfully we have people like Dr. Summers and Dr. Cohen who get it, who brought it here, who know how to use it for our patients, and it's something that we're going to continue to use. And then last but not least, let's not forget we still do have surgical aortic valve replacement and I. I think now going forward we need to figure out what's going to be the best valve for the patient. Obviously there's plenty of ads out there for Tver. If I didn't believe in TAVR, I wouldn't be here. I wouldn't be co-directing the program, but there's some people who still do need a sternotomy in 2026, and that's what our job is as the valve center is to figure out what's going to be best for them. And with that, I will thank you. I will thank Doctor O'Neill and his wife for joining us here today. Um, and Doctor Summers and I would be happy to take any questions if anybody has here any in the audience or online.
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