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Introduction | What happened to Carotid Stenting
Introduction | What happened to Carotid Stenting
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Background & History | What happened to Carotid Stenting
Background & History | What happened to Carotid Stenting
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Carotid Stenting
Carotid Stenting
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Embolic Stroke | What happened to Carotid Stenting
Embolic Stroke | What happened to Carotid Stenting
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Protection Devicees | What happened to Carotid Stenting
Protection Devicees | What happened to Carotid Stenting
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Randomized Trials | What happened to Carotid Stenting
Randomized Trials | What happened to Carotid Stenting
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Transcarotid Stenting | What happened to Carotid Stenting
Transcarotid Stenting | What happened to Carotid Stenting
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Should all patients be treated with TCAR | What happened to Carotid Stenting
Should all patients be treated with TCAR | What happened to Carotid Stenting
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Conclusions on TCAR | What happened to Carotid Stenting
Conclusions on TCAR | What happened to Carotid Stenting
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Alternatives to TCAR | What happened to Carotid Stenting
Alternatives to TCAR | What happened to Carotid Stenting
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Newer Stent Designs | What happened to Carotid Stenting
Newer Stent Designs | What happened to Carotid Stenting
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Sudden L vision lost | TCAR | 75 | Male | What happened to Carotid Stenting
Sudden L vision lost | TCAR | 75 | Male | What happened to Carotid Stenting
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Bilateral amaurosis fugax | TCAR | 63 | Female | What happened to Carotid Stenting
Bilateral amaurosis fugax | TCAR | 63 | Female | What happened to Carotid Stenting
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Asymptomatic CAS | Membrane covered stent | 75 | Male | What happened to Carotid Stenting
Asymptomatic CAS | Membrane covered stent | 75 | Male | What happened to Carotid Stenting
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Conclusion & Questions | What happened to Carotid Stenting
Conclusion & Questions | What happened to Carotid Stenting
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Transcript

So I thought this would be actually a very short talk because as a surgeon my answer to what happened to carotid stenting was going to be "it's dead". And we were just going to go back to doing carotid endarterectomy. But I guess that's not going to give you very good

information. So I just thought I would start from... really I hate to just talk about carotid stenting because you really need to talk about what's the right thing to do for patients with carotid disease. So just as a background

you know 75% of strokes are ischemic and most common source of that disease is extracranial carotid artery especially the carotid bulb. Embolic strokes are more common than thrombotic strokes and really those are the ones

that we are going to be worried about. Sorry so little bit of background again. The history - the first carotid endarterectomy was performed in 1953. So we as surgeons have a long history of taking care of carotid disease. First

report in the medical literature in Lancet in '54 and then roughly a hundred and forty thousand carotid endarterectomies are performed annually in the U.S. And it is still the most commonly performed major arterial

reconstructive surgery. And here's the nice pictures that if you ask five vascular surgeons probably six of them would say this is my favorite operation. So it's a very nice dissection this is the common carotid artery the external

carotid artery with its branches and the internal carotid artery here putting a shunt in to preserve blood flow to the brain and taking actually out the plaque and putting a little patch on the artery to make sure it doesn't stenose. And

here's what it looks like at the end. So unfortunately it still leaves a pretty good scar in the neck and it's a real operation. So what actually happened and I like to term it well the Interventional Express came along and

the cardiologist and the radiologist and some forward-thinking vascular surgeons I think thought that you know maybe there's another way to do this. And so going back now quite a ways if you guys don't know this story it's a great story.

Dr. Foresman did the first cardiac catherization. He actually did his own cut down put a catheter into his antecubital vein and threaded the catheter walked down to the cath...to a fluoroscopy unit and thread it

into the right atrium. So that was the first cardiac cath done. Obviously right heart cath. But fast forward in 1956 he then got the nobel prize for this with a couple of co-investigators. And finally in 1958 Dr. Sones did the first true

arterial coronary angiogram. '64 Dr. Dotter did introduce the concept of transluminal angioplasty so to actually open up an artery from the inside as opposed to the outside which is what surgeons have been doing for a while. And

then Dr. Gruentzig did the first peripheral balloon angioplasty about 10 years later. And now getting to carotids. Klaus Mathias in Germany actually did the first carotid angioplasty in 1979. So we've actually been talking

about carotid intervention for a long time and it's been done for a long time. By 2000 there was a global experience reported by the Wholey's and a bunch of other big names on this as you see. And in 2000 there was already

5000 carotid procedures have been done worldwide. The success rate was 98% the TIA rate was 2.8% stroke rate of 2.7%. And if you add it all up to combine major and minor strokes and procedure

related death it was only 5.1%. This is back in 2000. So four years after that we finally got on board in the US and the FDA approved the first carotid stent platform that was the Guidant platform and very soon

afterwards the Cordis platform was approved. And we now have a number of platforms available as some of you may or may not know. So I thought for the

next three hours we would probably just go over all these trials if that's okay. So

obviously a lot of time and effort has and a lot of money has been spent by industry to actually look at this. And so the question is why are we still talking about this and what happened to carotid stenting. So if we

can take a lesion that looks like this which I would venture to say that most surgeons would not be anxious to approach this lesion because it goes for a very long distance high up in the internal carotid. And if you can make it

look like this why are we still talking about carotid stenting and what happened. So here's the reason. Because this is what these things look like from the inside and all surgeons know this and it

makes us nervous to put a wire and a balloon and a stent through this. And so embolic protection is the holy grail for carotid stending. And it's why we're still talking about it why is not completely replaced endarterectomy. So

current treatments really for carotid stenting... this is kind of what you all see. There's a little basket here a filter and here's a stent coming to treat this lesion. So there is a less invasive alternative. It's

patient-friendly and durable as proven... I'm sorry i keep getting wrong button... as proven in the CREST trial. But there is clearly still excess procedural stroke risk. So when you look at endarterectomy vs stenting even though

the overall risk when you add MI into the picture is equivalent. The stroke risk is clearly higher with stenting. So because the procedure itself can create thromboembolism and we're going to talk about that.

What causes peri-procedural stroke which is the real issue. Well traditional carotid stenting from a transfemoral approach requires several steps that can create and embolic risk. So you have to advance the

catheter from that femoral artery through the arch and if you follow me this catheter now potentially scraped off plaque from this arch disease into the left subclavian and the left vertebral so there's the first brain

artery at risk. When you're trying to treat a right carotid so left vert it then went by the left carotid so there's a second artery it went into the innominate which could theoretically then embolize the subclavian and the

right vert so there's a third one and here's your target lesion. So all four vertebral... all four cerebral arteries are at risk when you do a trans-femoral stents. And that's been proven in the trial so navigating and then the

last is you actually have to get through this lesion with your protection device before you have protection. So embolic

stroke again is the issue and so the lesion. Angioplasty pre or post stent

deployment placement of the stent and retrieval of the EPD. All of these steps have embolic risk. And so how do you quantify that. Well a lot of studies were done looking at transcranial doppler. So if you take endarterectomy and look at the

number of hits on TCD that you see. It's... this is the mean number 52 plus or minus 64. If you look at transfemoral stenting its four times. That so it's real.

and how do they work. So this is a trial

done quite a while ago actually looking at early outcome of angioplasty and stenting with and without protection devices. So nobody would do this anymore but it was done and looking at the difference in carotid stent cases that

were done with stroke and death within 30 days 1.8% percent with protection 5.5% percent without protection. You should not be doing this without protection that's pretty clear. And it's

mainly due to a decrease in the occurrence of minor and major strokes whereas the death rates were almost identical. And here's just a bar graph picture of the same thing so here is unprotected cases and as you can see in

the early days there was a lot of cases done unprotected and here's protected cases you know towards the end and clearly an improvement so neuroprotection is a must.

Randomized trials... I'm not going to go

through all those that we looked at... but here are a couple of big ones. So ACT 1 was a interesting trial in the fact that it was done on acceptable risk patients. And I hate the term low risk because if you have a carotid lesion you're not low

risk for anything. So acceptable risk for surgery patients. And the bottom line is CAS - carotid stenting - clearly established as a safe and effective procedure. And I think the shift really was away now from and that's why we're here today

talking away from carotid stent vs and endarterectomy. But can we actually optimize carotid stent outcomes. So can we pick the right patients to do carotid to offer carotid stenting to. And here's the composite endpoint for years not

statistically significant obviously between CAS and CEA. But remember again composite endpoints in all of the stroke in all the carotid stent trials include stroke death and myocardial infarction. Because if you take the MI picturing

out of it carotid endarterectomy is clearly a... excuse me... if you take the MI out of it carotid endarterectomy clearly has a lower stroke risk. So the other big trial was CREST. Looking at again

endarterectomy vs stenting and here again is your composite endpoint of death stroke or MI not statistically significant 5.2 vs 4.5. Primary endpoints equivalent. But again all strokes at 30 days were significantly

higher in carotid stent cases. And that continued out to 4 years. So equivalent if again if you add MI into it. But again this is now a technology that continues to improve and the progression of EPD or embolic protection devices has gone

from distal protection... so here and you know there's seven or eight of these filters now available... to proximal protection. This is a big device that you have to get in and occlude the common carotid

artery so you have no antegrade flow as your protection. And then what is the newest and I suspect is probably going to stay transcervical access with flow reversal which were going to talk a little bit about. Again to show

you the embolic risk is the big issue. And there is a 2x peri-procedural stroke rate for transfemoral CAS when you compare to carotid endarterectomy. So if you look at stroke 4% in the

transfemoral CAS group. 2.3% in the CEA group. And the peri- procedural stroke in patients that are over 75 look what happens here and we're going to talk about why. So the in the endarterectomy group a little bit

higher but not much but in the stent group goes up very significantly. And here's the the bottom line day 0 stroke is the culprit. If you make it through the procedure without a stroke you're probably not going to have one or

a very low risk and not much different than endarterectomy. But here's the issue so its procedural embolic strokes that were trying to avoid. So how do we

think we can do this and T car is the new term that it's been used for trans

carotid artery revascularization or some of you may know it as the Silk Road procedure and that's what I want to talk a little bit about so the proof of concept is in it has been long in the making

even though this is relatively new so can you do flow reversal and decrease your stroke risk and all of these very small studies look at the major and minor strokes extremely low compared to anything in the literature so it works

flow reversal work so if you can make flow in the internal carotid artery go backwards while you're intervening on a lesion that's the best flow reversal that you can have short of putting a plant on the carotid artery and yours

the t'car procedure as we now know it so you can barely see this little incision but you make a small incision at the base of the neck you can clearly do it under local anesthesia and you establish basically an arteriovenous

fistula so if here's the carotid artery arterial sheep here's a femoral vein sheath and obviously arterial to venous flow this is the direction it's going to go there is a little flow controller and you can

control the flow rates and there's a filter in here that will catch any ambala debris that comes out so what are the advantages of the procedure clearly you can establish symbolic protection before you cross the lesion

so if you remember the list of steps that create ambala crisc it's you have to get your filter through the lesion before you're actually protected here you have protection before you actually cross the lesion and you create flow

reversal or surgical back leading as we can think about that if you just put a clamp on the common carotid artery and open up the carotid artery you'll have flow reversal down the internal and here i think is probably the biggest piece of

this whole puzzle is avoiding the aortic arch and especially as we get to older folks that number that i showed you once you get to 75 or 80 the arches become more difficult more angulated more calcified and are clearly a stroke risk

This is just a little picture of the arterial sheath here for the device. So advantages again established embolic protection before you cross the lesion. Here is another really pictorial of what happens with embolic risk again looking

at TCD data. So placing the sheath there's essentially no risk there. The wire hardly has any risk. But as you go up here with predilataion stent placement and post dilatation you clearly have embolic risk before you

have before you've crossed the lesion with your regular transfemoral stent. But with the TCAR you really establish flow reversal. Again here's your endarterectomy but a couple of things that you actually avoid. There is no

filter so is no vasospasm. So those of you that have seen transfermoral carotid stent procedures with a embolic protection device vasospasm clearly happens. And if you get enough stagnation flow you can

clearly get thrombus above your filter which is even an bigger problem. DW-MRI has been performed on a lot of patients with TCAR and the percentage of new lesions seen in TCAR versus CAS vs CEA are clearly favorable

for theTCAR patients as opposed to the transfermoral stent patient. And in case you if you're keeping up with this literature there is clearly evidence now that neurocognitive decline is associated with some of these

asymptomatic new DW-MRI hits. So what happens here. Can we really prove this so these are a list of studies and cut to the chase here this is a endarterectomy trial or the endarterectomy arm of a stent trial I should say. The percent of

patients that had new DW-MRI lesions 17%. This is transfemoral stenting look at the numbers there. This is transfemoral with proximal occlusion the MoMA device that big device that I showed you. It's kind of intermediate here

because getting that device in is an issue. And then here is the initial TCAR trial proof and we are in surgical were in the surgical realm with the number of new hits that we're seeing. So clearly it works. Avoiding the arch is

the issue and if you look at predictors of cognitive decline in stent vs endarterectomy there's a big statistically significant difference here. And again predictors of cognitive decline seen in another

pictorial. So should all patients be

treated with TCAR and is that where carotid stenting has gone. I'm not sure that's the right answer but clearly in many patients it is because with transfemoral CAS

you've got arch manipulation leading to new DW lesions and are some of those strokes. Well clearly if you see them on MRI they're a stroke even though they're asymptomatic but is neuro cognitive decline a real issue and I

would tell you that it is. So there are more and more papers coming out that say these essentially asymptomatic hits are not good for the brain. So here's the a little data on TCAR. The ROADSTER trial was the U.S. IDE trial looking at at TCAR.

So it's a prospective single-arm multicenter trial 14 sites were in the US and obviously we were one of them. Using the transcarotid neuro protection system. Pivotal trial enrolled a 140 patients... sorry

18 sites..Some they were symptomatic and asymptomatic patients. This was a high surgical risk trial so not acceptable risk only high surgical risk is defined by CMS for all of the other chronic stent trials. And then we looked at

30-day stroke death MI. And again to cut to the chase the numbers are very very low so these are the best numbers that have been seen in really any carotid stent trial. So this is the intention-to-treat group

which 141 there was 5 patients that really fell out per protocol. So if you look at those the numbers are even better. But even if you focus on the entire group that was treated stroke and death was 2.8% and

that's lower than any other stent trial carotid stent trial out there at this point. So is this the new bar for carotid stenting and is this were we now are. So here are the high-risk patients seen for endarterectomy and carotid stenting

in the SVS data or the Society for Cascular Surgery database. So carotid endarterectomy is somewhere around 3.6% carotid stenting is almost 5%. Here's the trials on standard surgical risk were still

higher than our ROADSTER data of 1.4% for stroke. 12-month outcomes in patients who we think are even higher risk. So if you look at age 75 there were no strokes no deaths

excuse me no minor strokes death here so stroke and death rate of 3%. So quite a bit lower than the high-risk group seen for SVS and the other trials. And then the symptomatic patients who we all think have these lesions that are

probably at higher risk were even low. Octogenarian. So the patients who have those bad arches clearly have increased neurological events and more DWI lesions seen in these older patients as documented in the number of trials. And

here's why. So we get and we get more elongated arches with more calcium and increased risk of embolic events. And as you see as we get older look what happens to the type of arch. So the nice flat arch that we all want to

see for transfemoral stenting just keeps getting less and less and more and more of these type 3 elongated arches that are more difficult. But again TCAR data for octogenarians and symptomatic patients was actually quite good. So

again here's the question what's happened. Should all patients with carotid lesions be treated with TCAR. And I would tell you that all of these femoral stent trials as the technology has gotten better we've gotten better

at all of these things. So even from the groin I think carotid stenting is not a bad procedure at this point but I would venture to say that TCAR is probably a little bit safer. Again not going through all of these data but if

you look at the numbers TCAR the early data with ROADSTER you know this is right in the realm of better or at least equivalent to some of the of the transfemoral stents. And I would say that ACT 1 is probably the

important one to correlate this with. But remember ACT 1 are acceptable risk patients and these are all high-risk patients. So to have the equivalent numbers I think is impressive.

So for TCAR I think it's probably

worth considering in all CAS patients. I think there are some that are more likely to benefit than others. So clearly the unfavorable arch the older patients the ones that have a lot of disease at their art vessel origins even though it

may be a type-1 arch if there's a lot of disease there and clearly in symptomatic patients. So we have really embraced this in our practice and we're now up to you know sixty-eight patients some in the initial trial ROADSTER 2 is the ongoing

trial. There's now some that this is an approved device so there are commercial patients that can be done as long as they're high risk and symptomatic as defined by CMS. And the proof really is in the filters. So when you do these

cases and you cut the filter open at the end I think it is very impressive what actually comes out of these carotids. And I would venture to say that some of the baskets that we used in transfemoral cases with an embolic filter this would

overwhelm the filter if it got... if it you know... if it was being done with a distal protection device. And just remember that stuff unfortunately does get by these filters and so it's a little bit sad but I think it's the

proof is in the pudding...alright you saw it. So I want to talk a little

bit about some other options though because it's not all just about TCAR. So this is the arch that we all want to avoid and this is what they look like

and why we get scared about going through those. But there's other options so you know Dr. Vingen talked about radial access for most things well why not for carotid stenting. Access site complications are one of the

most common adverse events after CAS from a femoral approach. And most technical failures when you go from the groin are related to a complex arch. So why not try and take the arch out of the issue and if you can do a carotid stent like this

like we did last week it's pretty nice. And the patient's really like being stuck at the wrist instead of in the groin. So you know there's all kinds of guides and catheters that can be use to access an arch

the access to carotis. So here's obviously a right radial approach going down into the innominate and then back up into the carotid. You've avoided the arch. And so you can you know put a stiff wire in the external so that you can get support to

get your sheath in. And then before and after. You can go here i would say you're not avoiding the arch but what if you had a patient that had bad a aortoiliac disease and didn't have femoral pulses and you need to go from above to get to

the arch. You can go from the right side to the left side and so right wrist or left wrist access is possible. And here's one coming from the left side going up the right side. So I think you can do this safely we have enough good radial

access sheaths at this point. And certainly the devices have gotten small enough that you can put an EPD and a stent in through 6 Fr and even sometimes 5 Fr systems without too much trouble. So wrist access clearly

this is kind of the same list that Harlin showed. So there are advantages. Clearly bleeding risk is minimal anticoagulation is not an issue I think you do have some reduced costs and I think outpatient performance

who knows maybe we can at some point. But there are some disadvantages. So most of us unless you're a cardiologist don't have much experience do radials. And so I think there is a learning curve if you have a type one arch

maybe it takes a little longer to do it from the wrist than the groin but that's a toss-up. This is the issue. You can't use proximal protection in larger devices. So I think if you believe truly in proximal

protection and if you have a lesion that you know a symptomatic lesion that looks ugly and you really want proximal protection so again you don't want to cross it with your filter before you treat it

this is probably not a great idea. And there is a radial artery occlusion rate of about 10% when you look through the literature so I think it's feasible and it can be safe. It's easy access in some difficult

anatomies. It does eliminate some issues. So to end I'm going to show you just a

couple of cases and tell you about some newer things that are coming up. So not only just protection but also stent designs are changing. The GORE Scaffold

Stent is an interesting stent in the fact that it's very flexible it has an open-cell design but it also has a mesh covering over it. So the pore size is small to still allow flow to go to the external carotid artery while you're

treating the internal carotid artery. So it's not a true covered stents but this is an exciting trial which were part of as well. And then in Europe there's a Cristallo stent that's available and if you look closely you can see that in

the middle part of this stent it looks like the meshes is tighter and so you have better coverage of the lesion. Because some people think that actually one of the issues with stroke after the procedure is already done is cheese

grating plaque through this this stent. So if you have more coverage of your lesion you may be better off but it's flexible and open at the at the end of the stent. So that's not available for us but it's

up with. So this is a 75 year old man with sudden vision loss in his left eye. The usual risk factors. Had a have a PVL and outside institution which was deemed normal. And then there was a CTA done to look at the culprit lesion.

And I'm going to show you just some still pictures because I want you to look at a couple of things. So calcium in the arch. Again 75 year old man remember. Bovine arch. So all of a sudden now we got two complicating factors and a

calcified lesions here symptomatic. And here's what it looks like. Obviously we did this with TCAR so there's a little carotid cut down here. You can see our retractor in place. And a very tight lesion which doesn't look perfect but

a little different to the cardiologist who say...yeah it's a little bit hazy here and it's not perfect...we would accept that. Because if you remember if you go from a 90% lesion to a 30-percent lesion in the carotid you never

treat a primary 30-percent carotid lesion. And again the proof is in the pudding. So the hemodynamics the next day by duplex... this is an internal crowded waveform in the stent and they're normal. So leave that alone.

Don't get crazy about trying to make it look perfect.

Here's a 63 year-old who presented with bilateral amaurosis fugax. She's morbidly obese. Here's your BMI and the usual risk factors. And her duplex showed

that her right carotid was occluded and the left side had a real lesion. She again had CTA for anatomy and again we've got calcified arch. Here's the origin of the left carotid which here looks bovine...it's really not...but clearly

there's a little speck of calcium there as well. Here's the right side that's occluded and here's your left side that actually has a very tight lesion at its origin. And another picture there so here's the lesion intraoperatively. Again

here's our retractor down here. So she was done with a transcarotid revascularization as well and here's that picture there. This again

asymptomatic now bilateral CAS and you're going to say well he's 73 so he's

not high risk by age alone but what's a high-risk criteria and so bilateral lesions will qualify you as high-risk. Both sides are greater than seventy percent. And again CTA done with calcium in the arch. Calcium here

which looks not very favorable. Here's the right-sided lesion which actually was not as bad as the left side occlusion. So again done with the TCAR in the OR. And there's the final

all our cases with TCAR I'm going to show you the last case here which is a 75 year old who had a previous left carotid endarterectomy for an asymptomatic stenosis with a patch. He had a laryngeal nerve palsy which is one of the things

that clearly stent buys you advantage with with no laryngeal palsies. And 18 months later came back with a high-grade asymptomatic recurrence that you see here. But a nice looking flat type 1 arch which was then done in the GORE scaffold

trial. And I just show you this because remember i told you this is a membrane covered stent and people were worried about preserving flow to the external. But it really actually looks very nice when it's done. So here's my answer.

I think carotid stenting is here to stay maybe not in the same iteration that we talked about 4 or 5 years ago where everything was transfemoral...it's the only way we could do it. But I think it is here to stay and it's an exciting time

to be in the field. So thank you very much for the invitation and I'm happy to answer any questions. Thanks. Leading question. And sure the answer is yes. It will be different so i think it's

not just the arch though I think once you get past that and get into your carotid clearly you've got a lot of other steps but you know Magellan and the catheters are going to allow us maybe to use proximal protection.

Which i think is a big piece of it not just getting there but if you believe that proximal protection you've protected the brain before you cross the lesion is also a big piece of it. So we'll still need to if you're going to

use a filter you're still gonna have to go through that lesion. So. Yeah. Great great question. And so and out of all of these patients we've not had a stenosis at the access site. And you know

it's still in the common carotid so we can see it with duplex. So yeah. And then all of the stents and everything are the same so that data is out there and those stents are performing well. Alright. Thank you.

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