that you have to give a talk. So this is just like this on the spot. So that's amazing. So I have no financial disclosure. These are clinical trials that I participated in over the last 15 years. Essentially every carotid STEN trial, all the randomized trial, and also the international PI for the Rooster trial for the long-term follow-up with TCAR. Essentially, you know, we're gonna talk about carotid. We love carotid, everybody in this room probably, because we can actually prevent stroke. And stroke is the most debilitating disease in the Western world, and it's still the leading cause of disability and the fifth leading cause of death. And we can prevent maybe 5% to 10% of the stroke if we treat a carotid patient appropriately. We do a lot of carotid revascularization. Probably we overdo them, over 140,000 in the US. The cost is really astronomical. And I wanted to show you this. I'm sorry, while you're eating. But this is how carotid lesion look. And I think it's important for, you know, my colleague in cardiology. I always invite my cardiology colleague to come and see a carotid patient, typically when they refer the patient to me. But you see this intraplaque hemorrhage, and this help us understand that carotid disease is an embolic disease, is not really an ischemic disease. Carotid stent that Gary's talking about is essentially started with the concept that, hey, we can do this with the coronary. Why can't we do this with the carotid? The only thing is the carotid is not similar to the coronary. We talk in ischemic disease versus embolic disease. A lot of things in medicine we do for one reason, and it works out, and it works out very well. And transformal carotid stenting is one of these procedure that it worked very well, because if you ever take a stent, you understand why carotid stent work, because it stabilizes the plaque, and you develop this intimal hyperplasia, and you don't have this irregular plaque that I showed you. The key, though, is to do it safely. And this procedure is probably the most dangerous and the vastest procedure we do. And all the stroke rate from every clinical trial you look at happen in day 24. Majority of these stroke. So if we do it safely, the long-term outcome is actually similar to CEA. These are the landmark trial that we all know, but I think I bring it up is to bring that when you treat an asymptomatic patient, for instance, the ACOS and the ACST show the benefit up to five years, essentially. And so if a patient doesn't have a four to five year survival, we probably should not be treating their asymptomatic carotid. Also, the stroke rate from the procedure should be less than 2% for asymptomatic patient, and less than 3% or 4% for symptomatic patient, regardless of what carotid procedure you do. So whether you're a surgeon doing CEA or interventional cardiologist doing stenting. I do very rigid criteria in my lab to look at the carotid, and many patients get referred to me. You know, someone told them you have a tick and bomb in your neck, and you need to be admitted to the hospital, and I scan them, and they really barely have any elevated velocity, and all they need is medical management. So you see the criteria here that we use. But carotid duplex is not perfect. You see here the echoing on the left side because of the calcium. So if you really, you can't really do any carotid revascularization today without getting a CTA. You gotta start on the arch, you gotta look at the arch, see if the patient is a candidate for transfemoral stenting. You gotta look at the lesion, how calcified, how severe it is, how is the tortuosity of the carotid. If you're planning to do CEA, is the lesion super high that you can't really get it? It's not just where the lesion is because your patch is gonna extend further up, so you need another maybe couple of centimeter beyond the lesion to have a safe carotid in the arrectomy. So if the lesion is high, probably better off with stenting. And MRI also I get on any symptomatic patient to see what's going on with their brain. You know, do they already have DWI, for instance, or a small stroke? And it's very helpful to have that baseline. Perioperative medication, and I said perioperative, meaning before, during, and after. So dual interplatelet, again, if a patient doesn't start clopidogrel when I tell them to do it and they show up in the morning, I actually send them home. I no longer load them. I tell them, go do what I told you to do and come back when we reschedule your cases. I do check on their reactivity to clopidogrel routinely, and I found a lot of patients who are non-reactive and there are other options for P2Y12 inhibitors. And I'll show you, you know, other things, you know, like we all know that statin is super important, but we were first to show that it actually reduced the risk of dying from carotid stenting if you develop a stroke or MI. And so what we call a rescue phenomenon. Of course, today, you should not be doing any carotid revascularization without a patient on statin or something similar to statin. Beta blocker also, surprisingly, was beneficial, especially in patients who are hypertensive and many of these patients who get carotid revascularization are hypertensive. These very well-known high-risk criteria that CMS have, I think a lot of them didn't make sense, and so we kind of spent almost a decade kind of studying them in real-world data. We found, for instance, if a patient had re-stenosis, carotid stent, transfemoral stenting, is far more superior than redoing carotid endorectomy because there's a dramatic reduction, not only in cranial nerve injury, but also in stroke and death. As a matter of fact, if the patient re-stenosed their stent, this was, when we published this with 700 patients, it was the largest paper on re-stenosis for stent. What do you do with that? And we found, again, that most of these patients, you can manage them medically, and if they really have progressive lesion, symptomatic lesion, then an endovascular intervention is actually better than doing a CEA. As a matter of fact, in this stroke publication, we showed that when you operate on re-stenosis, that's probably the safest stenting procedure you do because you have intimal hypoplasia, and these lesions are not symptomatic and unforgiving. Now, age was the opposite. So, age is a criteria for every single carotid stent trial as a higher-risk criteria for CEA, but we've shown, first with CREST-1, and then with this massive study, over 90,000 patients, that actually, once you hit the age 65 to 70, CEA is actually better than trans-femoral stenting. On the other hand, trans-femoral stenting do very, very well in patients who are younger, and that was kind of the starting people reverse what they think about who should get what and how you select these patients. Why elderly do bad? Because they have typically bad arches. They have more tortuous lesion in the arch and in the carotid itself, and they have a lot more severe atlas carotid disease. And these are examples where we actually should, today, you can't really do a carotid trans-femoral stenting on a patient like this in CREST-2. It would be rejected by the interventional committee because you have type 3 arches or you have severe atlas carotid disease. And you shouldn't really even be doing an angiogram because you should get all your information from your CTA. Again, lesion like this, yeah, you can probably get a stent, but your filter is not gonna sit properly and you're not gonna have a good protection. This is poor analysis, like looking at all these risk criteria that we talked about where it shows in meta-analysis, multiple study, how patient do worse if they have bad arches, calcified lesion. We did our own study with calcified lesion, and we showed that once you have more than 50% severe calcification, stenting is typically not gonna do well, whether it's TCAR or trans-femoral. Also, lesion length. If the lesion is more than 25 millimeter long, it doesn't matter with CEA because you're removing the lesion. It doesn't matter how long it is, but with stenting, you kind of, this is an indicator of more disease, more severe disease in the coronary and in the arch, and you're gonna have worse outcome with trans-femoral stenting. Surprisingly, contralateral occlusion also was a higher risk criteria for stenting. We thought it was a higher risk with CEA. It is a higher risk for anything because it's an indicator of severe disease, diffuse disease, but when we compare trans-femoral to CEA, there was no difference in the asymptomatic patient. In the symptomatic patient, there was dramatic increase in the risk of stroke and death with trans-femoral stenting. We showed this concept first in 2017, American Heart Association, that maybe we got it all wrong. Maybe we need to do trans-femoral stenting in younger patient who have good lesion, not severely calcified, not super long, and you see here in the middle, in standard risk patient, the procedure did well. There was no advantage of CEA over trans-femoral as far as stroke. A couple of technical points. One of the major advantages of trans-femoral stenting that you can do are under local and you can reduce your cardiac complication. We showed a 20% of cardiac stenting done in this country under general anesthesia. These patient had increased risk of mortality and cardiac complication. Almost, you lose the benefit of reducing the risk of MI when you put them asleep. We also talked first about not ballooning the stent because we were able to show for the first time of this study that if you can double the risk of stroke and death when you balloon the stent because you're pushing the stent through the lesion and you're embolizing into the brain. And if you're super selective and you follow these very strict technical tips, very aggressive medical management, you say no to a lot of patient, you can get your stroke rate down to 1%. This is our own data with trans-femoral stenting. This is a risk calculator that I think is very helpful because you can use it to kind of think about if this patient really need anything. So if your risk of stroke is predicted to be 11%, symptomatic, 80-year-old, can't take statin, diabetic, for instance, with bad arches, and their predicted stroke is almost 13%. So should we really operate on this patient with trans-femoral stenting? So that brings us to the topic, a little bit of talk about TCAR. So TCAR, you avoid the arch. The floor reversal is phenomenal. You clamp the CEA, so you provide CEA-like protection. This is some of the filter, like one filter, one of the procedure. You can see it's very effective in capturing the plaque. But if you look at, this is a study, we looked at 200 patients, for instance, 25% of these patients on CT scan did not meet the qualification for TCAR. You have to have a very healthy common carotid. You have to have a landing zone of five centimeters to the carotid bifurcation. Your carotid cannot be super deep. So not every patient anatomically can get TCAR. We're not even talking about also severe calcification and longer lesion and whatnot. We're talking about just the axis. But in these patients who get TCAR, the risk of DWI was equivalent to CEA. We showed first, in the large analysis, over 3,000 patients, propensity score matching, that there was no difference compared to CEA as far as stroke and death. There was reduction in the risk of MI, similar to trans-femoral stenting. There was dramatic reduction of cranial nerve injury as well, 90% similar to trans-femoral stenting, which is 100% reduction of cranial nerve injury. In this propensity score matching, we looked at up to essentially three years, and there was no different in the long-term outcome between the two procedures. When we compare it to trans-femoral stenting within real kind of word data, there was increased risk of embolization, whether TIA or stroke. And of course, this is retrospective analysis with all the inherited selection bias and whatnot, and I always say that we need to do randomized trial before we can come up to level one evidence. We cannot read these studies about age and contralateral occlusion, including the three procedure. We saw that age is not a problem with TCAR. And we also looked at essentially re-stenosis, and again, there's a benefit for stenting compared to CEA. And contralateral occlusion, again, was a bad marker for bad outcome in stenting altogether. But with TCAR, for some reason, it was not the case, maybe because of flow reversal. This is a recent topic that I did, looking at the new approval by CMS for both trans-femoral stenting and TCAR, and that was approved in standard risk patient, can be done anywhere. And we looked at 200,000 patients to kind of look at really what are really the highest criteria that matters, and these are every single patient had one of either anatomic or medical. And we found that radiated patients, there is no question that trans-femoral stenting has a huge advantage over CEA. And also patient, again, with redo procedure, there was a dramatic reduction in cranial nerve. And I tell you, like, you know, surgeons don't really think that cranial nerve injury is sometime important, and I disagree, because few patients, actually, cranial nerve injury don't recover from, and it's very debilitated, and if you look at the patient and ask them from a patient perspective, they prefer to not have this procedure altogether. So in conclusion, I would say, you know, if you look at a patient and you wanna do a carotid vasculation regardless, they have to have a meaningful, good quality of life expectancy, at least four years, before you can intervene on them if they're asymptomatic. The stroke rate, as a surgeon or interventionalist, should be less than 2% for asymptomatic patient, less than 4% for symptomatic patient, maybe close to 3% even. I think TCAR and trans-femoral are far more superior to CEA when it get to restenosis, and also significant neck radiation. Severely calcified lesion, long lesion, probably better off with CEA. I think physiologically, anatomically, older patient, probably better off with CEA. They're gonna be older patient who have normal arch and lesion that not super long and atlas carotid, they probably do fine with trans-femoral stenting. And this whole definition of high risk criteria need to be revisited again, and again, I say we definitely need to do a randomized trial before we can come up with level one evidence to compare the three procedures. Thank you.

carotid artery revascularization

stroke prevention

carotid stenting

TCAR

randomized trials