Chapters Transcript Video Trans Carotid Artery Revascularization (TCAR) Good afternoon everybody. Thank you to dr democracy and all my esteemed colleagues this afternoon. Everybody's doing good. So I'm gonna be talking about T. Car which is transcribed artery revascularization. For some reason. This doesn't like it. There we go. Just having a little issue with the so what if I told you and this is what that deep morpheus voice. So it should be. What if I told you that there was a technology out there that could have the low risk of stroke of carotid endarterectomy and the mainly invasive opportunity of transforming artery stenting. Would that be a disruptive innovation or would that be marketing genius? So throughout this presentation I'm really going to be talking to you guys about T. Car and it's up to you. I'm gonna leave the end of the presentation, allow you to make that determination. But we'll go over T. Car as a whole and a little bit about the epidemiology of credit artery stenting ce, a transferable credit artery stenting. What the real opportunity is with the car and then talk about really the nuts and bolts of what um revascularization and flow reversal is. And finally we'll talk about the outcomes. I have no disclosures. The only thing I want to say is that card endarterectomy is actually the surgery that got me into vascular surgery. So I may be a little bit biased towards that. So corroded artery disease. 15 million people worldwide suffer from stroke yearly. About a third of those strokes are secondary to carotid artery stenosis. It's the fourth leading cause of death world in the United States. And it's the leading cause of long term disability in the United States I think that's the important thing here is that this long term disability is what we're trying to prevent. So there's been a lot of studies out there. These are some of our landmark studies Nasa E. C. S. T. A. Cast a cst really discussing all the options between karate endarterectomy and transform a carotid artery stenting. So under endarterectomy the pros low peri procedural stroke risk. Reason for that. You get to back lead your carrot and you clamp prior to performing your endarterectomy. The cons Cranial nerve risk injury which is about 2% and risk of M. I. Which is also about 2%. If you look at the crest data and some of the other data. The other thing about credit under direct to me is that even if you have a good outcome. Sometimes patients will complain about numbness, persistent numbness in the neck or issues with moving their neck kind of long term. They still feel that pain or twinge when moving their neck, transfer moral artery, transferable, credit artery scenting the pros here is really the it's a minimally invasive operation with low risk of M. I. And low risk of cranial nerve injury because you're nowhere close to the cranial nerves. The cons here is that there's a high procedural peri procedural stroke risk. And if you look at diffusion weighted MRI. There's about 87% of new lesions with distilled symbolic protection devices. So even if we these these studies have looked at it and that's the concerning things. What exactly during crossing the aortic arch and crossing the crossing the lesion are we sending to the brain? And sometimes we see it clinically with actually peri procedural stroke risk and sometimes we see it sub clinically and we're actually still sending things to the brain. So a lot of studies have been sent out there regarding stroke am I? And first starting, you know, a couple of years down the road and then looking long term. And really what we can glean out of all this is that credit artery stent thing is really good for in terms of low risk of M. I. And cranial nerve injury and endarterectomy has a lower overall stroke risk Interestingly enough though, if we look at carotid disease this is really the last frontier cerebral artery aneurysms, coronary artery disease, thoracic and abdominal aortic aneurysms and peripheral arterial disease have all moved to a more minimally invasive approach. But for carotid artery disease where over 75% still open and then about 25% endo and transform artery carotid artery stenting. So what can we offer our patients that's more minimally invasive. That allows for the same opportunities in the same exact or even better. Lower risks of stroke. So that's where the opportunity comes in. So that's where T carr was really formed. So here you're gonna make a transverse or longitudinal incision on the neck and get direct corroded access. You're gonna clamp the common carotid artery with a loop or a clamp itself and back bleed and to clear the debris through flow reversal. So here's a quick overview exactly what we're talking about when we talk about the car. So the vascular surgeon will create an incision here and get and I'll go through each step kind of individually and get access to the corroded artery. And then place are the end route or the silk road sheath here will establish a common common femoral or femoral vein access here. Usually on the contra lateral side but each side is okay. And then we'll we'll establish flow reversal through this neural protection. I'll go over that with a filter within that and then we'll do the standard carotid artery stenting that we're used to doing So flow reversal. This is not a this little box that we saw earlier is not some type of machine. There. All it really does is it uses the body's natural um It's actual natural venus pressure and arterial pressure with some pressure and actually allows for flow reversal. So you're not there's no actual machine in there sucking blood backwards. This is a natural low high pressure to low pressure system. So in in T. Carr, what you see is the on this one a transverse incision between the two heads of the stereo colonial asteroid what the vascular surgeon will then perform will place a you stitch or two usages um to allow for control prior to the carotid artery access will then place a catheter within the carotid artery and perform our carotid angiogram. Once that's completed, we'll actually establish our full sheath system and then perform the standard Credit artery stenting the stent itself. It's a monorail rapid exchange system. The stents are about third or between 30 and 40 in length and there's a bunch of different options available. So just a couple of pictures right here and for people that are really interested in kind of closed cell design and open cell design. This is an open cell design stand and it actually auto taper. So sometimes even when you got a result that looks kind of like it didn't taper well over time. This will taper and look very nice post procedurally patients are on dual anti platelet therapy for about four weeks and then we differ kind of to the provider and remain on a high intensity statin medication violation is really the number one cause for any of these procedures and as well as any other procedures of really adverse events and then surveillance. These are just some copies of here of the SVS guidelines. But patients usually get carotid artery duplexes every six months and then two years and then annually after that. And there's an established criteria for clarity and instant re stenosis of the carotid artery stents. So looking at the Roadster trials. These are the there was a pivotal Roadster style trial and then there's been three Roadster trials really looking at T. CarR in regards to adverse events as well as stroke. Right now. We are actually on Roadster three and our our partners were the first ones in the country to enroll somebody and actually perform somebody in that trial. So on Roadster one they really looked at a major adverse events in terms of stroke death. And am I? And what we really established here is the low risk of stroke with T. Carr. That's a fantastic thing is the intention to treat patients as well as the per protocol pp. The stroke risk is significantly low looking comparatively to to karate under direct me which is still controls considered the gold standard at 2.3% versus 0.71 point 4%. Then Roadster two went further with a lot more patients and looked at the same things. Cranial nerve injury, stroke and death. And what they established was the same thing here is that your risk of stroke is incredibly low and that's really what we're looking at. We want the opportunity to have low risk of stroke during this procedure. So those those are the two trials but really there's no real good randomized randomized data. Looking at these patients. So the V. Q. I. Is a vascular vascular quality initiative has really been established to follow these patients long term and all T. Carr patients are required to be enrolled in these in these in the V. Q. I. And so what we saw here is that the first paper were high risk um crowded artery sending patients. What they established here is that there's a very low risk of M. I. And statistically significant as well as cranial nerve injury is statistically significantly low. And the length of stay as well is very low. And they're over. Our time was low liang at all on the standard risk patients. And V. Q. I also saw that their cranial nerve injury was statistically significantly lower and their stroke risks were very low as well. So looking at coming together with all of that you can compare the C. E. A. Data of crest versus the Roadster data in terms of myocardial infarction and cranial nerve injury because ultimately what we want is that low stroke risk with low M. Eye and cranial nerve injury risk. And what we got out of that was that the T. Car offers a overall lower risk of all three. And then comparatively to transform all carter artery stenting. There were statistically significant lower chances of in hospital Stroker death stroke overall and death comparatively between T. Carr and trans femoral artery and the stenting. Also notably on the on this V. Q. I. Data that dr schumer Horn found. Um. He also saw that the radiation uh efficiency and the contrast load was statistically significantly lower for teak are comparatively to transform real CS. So it's a novel procedure. It's been around for a little while of all of our partners offer this operation. And so what's the learning curve? There's been data to look at Surgeons that are doing 0-5 of these procedures and then more intermediate and expert level of T. Car. And there's no statistically significant difference in terms of outcomes for any of these patients. Overall, if you're able to offer this procedure, it is a safe operation, uh no matter which experience level you are then the major thing embolization rates. And this is really what we're talking about when we're doing transform carotid artery stenting were passing the arch and we're passing the lesion and we're really worried about embolization rates here. So, pre protection. There's no statistically significant difference in between the car and see A and embolization rates. So now we're proving that hey, even though we're passing this lesion, there's no more increased risk of embolization for during protection. There is no difference between the corroded artery clamp when the surgeon places that versus the T car flow reversal and post protection all three, which is transfer moral tran thi qar as well as see ea have similar rates of embolism afterwards. So as dr dexter had mentioned a little bit of clot porn. This is where we talk about clot porn. So what are we talking about when we are passing the lesion? This is what we're talking about. This is where transform card artery scenting is really concerning. Is that this is all the stuff that gets passed while we're passing our wires and balloons and catheters in our stents across that lesion. This this stuff all gets caught in the small filter within the in the T. Car system and typically we won't open it up. But some of the surgeons have opened it up here to kind of demonstrate what we're passing and what was saved during this procedure. So insurance coverage. One good thing is that now Medicare actually offers this for standard risk patients for but all other providers and concern. Yeah. And commercial insurance providers are still requiring it for high risk patients. So, high risk patients which most of us know follows into any of these categories, most notably of age greater than 75 prior head and radiation and surgery or radiation restenosis or a surgically inaccessible lesion. So now you've seen it and just like Neo at the after he goes through his teaching session with morpheus, you've learned all about this new awesome hybrid procedure. And so what do you think from my perspective and kind of my final thoughts on T. Carr is I do think that there is a role of this in this. I do think it's disruptive technology. I think that in a standard risk patient, it's going to be up to the provider to really look at and and talk to the patient in regards to offering ce A. Versus. T. Car for them and some of these high risk patients. I really think that T carr is the wave of the future. I do think that transform our carotid artery stenting is gonna be a very niche procedure for certain patients that do not qualify for C. E. A. And or for T. Car and that those patients will be kind of few and far between. I also think that crowded under our direct to me is here to stay for certain patients and that's for another talk for a different day. So it's up to you to decide disruptive innovation or marketing genius. I took the red pill. Thank you very much. Published Created by Related Presenters Priyam Vyas, M.D. Surgery - Vascular View full profile
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