- Good afternoon ladies and gentleman, thank you very much for the honor of this presentation. The ICA Pseudo-Occclusion has been defined as the critical more than 95% stenosis, a very small Lumen diameter with low velocities and there were several pseudonyms listed in the literature such as slim sign, string sign,
hypoplasia, or nearly occluded arteries over the years. The gold standard always been contrast arteriography, which is an invasive study but how about MRA or Duplex Scan? We know that MRA can only pick up velocities that are over 15 centimeters per second,
we wanted to see how does Duplex Scan does in this setting. The advantages of Duplex Scan versus Carotid Arteriography such as we can measure external diameter, not only lumen of the artery, we also could assess wall thickness, hemodynamics of antegrade versus retrograde
or bi-directional flow, thrombus presence, and assess very low flows. We had 29 Pseudo-Occluded ICAs in 28 patients with various ages, mean 73, and 80% of these people were on anticoagulation and they had typical risk factors for asovascular disease patients.
The diagnosis of ICA Occulsion was already given to these patients before they came to our clinic, with MRA alone in four cases, MRA and Duplex in 13 cases, and Duplex alone in 12 patients. And 12 of these were symptomatic with strokes, so TIAs. We modified the traditional Carotid Duplex Scan Protocol
to adjust the following settings for Doppler. We decreased the wall filter to minimal, pulse repetition frequency also to minimal possible for the scanner, and then we did careful spectral analysis of ECA and branches for exclusion of false positive diagnosis.
We found such in this case this was velocity less than five centimeters per case of second. We also adjusted settings for color and Color Power Angio to again decrease the pulse repetition frequency to minimum, decrease the wall filter, and increase the sensitivity and persistence to
maximum, and here is a standard protocol, the artery looks secluded, and here it looks patent. We also used curved probes for extended field of view, to increase the length of the assessed ICA, could recede over three centimeters like in this case, and we also used High-Definition Magnification
for the Distal ICA assessment to carefully measure the lumen, in this case it was 3.3 millimeters, and we can even see the very thin wall, less than one millimeter. Sometimes you could see the motion artifact and you wonder if this artery is patent,
but the color can be misleading, and this could be pulsation from the common carotid artery, so the doppler helps us to see that it's not just the flow, it's the motion artifact. We found that the 29 Pseudo-Occluded ICAs has very low velocities, all less than
30 centimeters per second, the stolic and systolic, and we managed them surgically in 10 cases, had to ligate six of them, and 13 conservatively. This is the video showing the previously shown Occluded ICA which is now patent, and this is the carotid endarterectomy on this patient.
The ICA was much smaller than the external carotid artery, but the exploration showed there is a pulsatile bleeding and this patient underwent successful removal of the plaque and patch angioplasty. We found following in the operating room,
one had to be shunted, we found pulsatile back-bleeding in nine cases, which was sufficient not to place a shunt, two cases even had floating clots, and all 10 were patched. The diameters of the measurements of the vessel in the operating room show that these vessels
were small, all less than five millimeter, but they had lumen which was more than two millimeter, and the very thin wall. In contrary, the patients who were supposed to be ligated, six cases, the outer diameter was a little smaller, and this patient had smaller lumen
and the higher wall thickness. So we found that the proposed modified duplex protocol helps detect extremely low-flow in the ICA and increase detection of patent arteries previously thought to be occluded. We suggest ICA endarterectomy for all patients
with ICA lumen more than two millimeters and wall thickness less than one millimeter, but non-operative approach for will be more appropriate for asymptomatic patients with the smaller ICA lumen and thicker walls, and the symptomatic patients probably have to be ligated.
- Thank you very much Ali, it's a pleasure to be here. I have no disclosure for this talk. Basically ultrasound-guided stenting was born from our strategy to decrease zero complication with carotid endarterectomy. As some of you may know we describe the mini-incision
of carotid endarterectomy, we don't do extended carotid endarterectomy for years. We select our patients properly, we do preoperative cardiac evaluation, we try to be precise, technical during the operation, and we do completion studies in all these patients.
Here, just to show you our mini-incision. We get an ultrasound, we mark the bifurcation, and therefore we can do a one inch incision and fix the problem. We don't rely just on our clinical expertise. We do an ultrasound, and show this big clot under the patch.
All this to improve our results. But in this process, we went and looked at our mortality rates. And, although the mortality appears to be small, there were five patients that actually died from this operation,
and we decided to look a little bit more into them. And we found that those four of the five patients had a creatinine above three. So, we decided that these patient actually are very high-risk cases, we published in JVS. And since then, our articles have proven the same thing.
That this patient extremely high-risk, and maybe we should not be doing carotid endarterectomies in patient's with high creatinine. So, we decide to do them under ultrasound-guidance, but there are limitations of course. The aortic branches cannot be visualized,
you cannot place the filter under ultrasound-guidance because it's up in the brain, and the cerebral vasculature cannot be seen. However, if you get an MRI prior to the procedure without contrast you can see the anatomy very well. Remember there's only three orifices in general,
and sometimes two in a bovine arch, so it's not hard to canulate them. And you can also place the filter just under fluoroscopic guidance alone, you don't need to inject dye. If you complicate, and probably less than 1% chance,
then you can inject five cc of contrast and obtain this arteriogram in two views. But, that's a rare situation. So, we had 41 cases, average age 74, more than half had high creatinines. So, we made a diagnosis with ultrasound alone,
and we did procedures also mostly with ultrasound. And here's the puncture under ultrasound-guidance in the common femoral as now we are trained to do, but 25 years ago when we mentioned this people said that this was not necessary, but actually I see that now most people do it.
We can place the wire and the sheath up to the common carotid, and from there on we got to go back to ultrasound. Even in a bovine arch, like this one here, was also very easy to cannulate just with fluoroscopy. And now we are into the common carotid sheath,
here's the internal, the external's up there. And you can see the filter wire coming in. It doesn't matter that the patient moves their neck, you don't have to keep injecting any dye, now it's going into the external, we're going to pull the wire out,
and place it in the internal carotid beyond the plaque, you can see the plaque right here. And now after placing the filter, we're going to bring the... And the wire's already there. So now, we're going to bring the stent.
There's the plaque, you can see it clearly, you can see the composition of calcium up here. And then, we're going to deploy the stent just beyond the lesion. And here's the stent being deployed. It really takes less than 35 minutes for this procedure.
And, here's the plaque, you see it did not move much, but it's still a stenotic area and therefore, this segment is going to be ballooned. Now, in some cases you don't need any ballooning, but this one need it. And here we are now.
We're going to balloon it. Again no dye, just saline. And after that we're going to confirm the adequacy of the technique. As you see here is the plaque, and here's the plaque with the calcified lesion.
And it's widely patent, and we measure the volume flow. When the volume flow is less than 100 ml per minute, we obtain a ... because maybe something intercranial, why the spasm, or we missed a lesion. But, it was over 100 ml per second we successify no problem has occurred or will occur.
Those are very high-risk cases, indeed. And 46% of the cases, we actually retrieve significant debris from in the filter. It took less than hour whether you went to the right or left, but the left side of course was a little bit
harder to cannulate, and took a little bit longer. We had technical success in all cases, and one patient had a TIA that recovered within a day. And therefore, we believe that one of the indications for carotid stenting now will be perhaps serum creatinine over three in patients that are symptomatic,
and asymptomatic probably they won't benefit from any procedure, and medical treatment probably is better. Thank you very much.
- Thanks Wes. So we're going to cover two devices in one talk here. Here are my disclosures of consultant to both companies. This is a gore embolic filter, GEF. Gore embolic filter was designed with a proximal ring which was meant to oppose the vessel but no distal architecture
except the embolic filter material and a flexible wire. And this was meant to allow for deployment in a difficult anatomy, especially tortuous anatomy, and when you line up the filters in a model of two model, flow model,
of tortuous anatomy and you inject material you see that, in fact, most devices in that kind of a tortuous model do allow particles to pass but the gore embolic filter had high capture efficiency. We actually ran a trial here
on this filter, a 30 day embolden trial, and I'll show you the results of that now. Here are the 30 day outcomes. This was a high-risk of cohort of patients for endarterectomy in the typical fashion. And the final death and all stroke at 30 days
was 3.6% and we drilled out into that. Octogenarians who comprise about 40% of the population in this study had five out of the 10 MAEs. For a rate for them of 5.4% and a rate for non-octogenarians is a 3.2%. Moving on now to the Contego system,
this is the Neuroguard. This was designed to specifically address the issue of filters allowing particular matter to pass as I just showed you with the gore embolic filter. Most filters have a pore size of between 100 and 120 microns and the Integrated Embolic system from Contego
has a balloon, post-deployment balloon, which actually has a filter that can be remotely deployed. It opens up with a dial in the back of the handle. It has 40 micron pores. The advantage there is that because the filter doesn't have to be up from more than a few seconds
during balloon inflation and deflation, it can have much smaller pores and not worry about flow limitation. So the idea here is to use it in combination with or as solo device. The Paladin study was run in Europe,
roughly a hundred patient study and I'll show you the results of that now. Here are the 30 day clinical results and this was independent of any of the types of carotid stents available in Europe. And you can see that stroke, death, and MI
at 30 days was 0.95%, and that stroke was related to a stent thrombosis of a mesh-covered stent at day 12, nothing into procedural or immediately post-procedural. So the clinical study results in a small trial, 105 patients, were quite good.
Moreover, in a single center there was a DW-MRI study performed looking at again all these symptomatic patients 'cause there were no strokes. There were seven new lesions for a total percent subject new lesions of 21.2% with very low volumes and on all patients.
When you line that data up as compared to most of the rest of the devices, both in filter as well as in proximal protection, this actually lines up very nicely with the roughly 17-20% endarterectomy due to new DWI hits. The filter particle size actually proved the concept.
Most of the filters captured here were less than 120 microns. You can see most of them were actually in the 80 and less so this would've potentially gotten through a standard filter device. The other things,
the other point to mention here, is that there is now an integrated system which hopefully will be approaching device investigation in the United States. It's a three-in-one system which has the remotely deployed filter,
a balloon and a purpose built carotid stent. And I have an automation here to show you how this works. As most of you who do carotid stenting know when stroke occurs it's not always related to the patient, there's occasional mischief that occurs
with device exchanges and so on, so this eliminates all that. It's a one-step procedure. You see now that the sheath will be withdrawn. The filter will be dialed open to fit the vessel.
It has a wide range of sizes. And then the sheath will be withdrawn to deploy the stent and then the balloon will be inflated to finish the stent deployment. And then the filter will be remotely captured using the dial.
As I mentioned before we have an approved protocol and we hope to move forward with the trial in the near future. Thank you very much.
- Thank you, chairman. Good afternoon, ladies and gentlemen. I've not this conflict of interest on this topic. So, discussion about double-layer stent has been mainly focused about the incidence of new lesions, chemical lesions after the stenting, and because there are still some issue
about the plaque prolapse, this has still has been reduced in a comparison to conventional stent that's still present. We started our study two years ago to evaluate on two different set of population of a patient who underwent stent, stenting,
to see if there is any different between the result of two stents, Cguard from Inspire, and Roadsaver from Terumo in term of ischemic lesion and if there is a relationship between the activity of the plaque evaluated with the MRI
and new ischemic lesion after the procedure. So, the population was aware of similar what we found, and that there's no difference between the two stent we have had, and new ischemic lesions is, there's a 38%, for a total amount of 34 lesions,
and ipsilateral in 82% of cases. The most part of the lesion appeared at the 24 hours, for the 88.2% of cases, while only the 12% of cases, we have a control at our lesion. According to the DWI, we have seen that
the DWI of the plaque is positive, or there is an activity of the plaque. There's a higher risk of embolization with a high likelihood or a risk of 6.25%. But, in the end, what we learned in the beginning, what there have known,
there's no difference in the treatment of the carotid stenosis with this device, and the plaque activity, when positive at the DWI MR, is a predictive for a higher risk of new ischemic lesions at 24 hours. But, what we are still missing in terms of information,
where something about the patency of the stents at mid-term follow-up, and the destiny of external carotid artery at mid-term follow-up. Alright, we have to say we have an occlusion transitory, occlusion of the semi-carotid artery
immediately after the deployment of the Terumo stent. The ECA recovery completely. But in, what we want to check, what could happen, following the patient in the next year. So, we perform a duplicate ultrasound, at six, at 12, and 24 months after the procedure,
in order to re-evaluate the in-stent restenosis and then, if there was a new external carotid artery stenosis or occlusion. We have made this evaluation according to the criteria of grading of carotid in-stent restenosis proposed on Stroke by professors attache group.
And what we found that we are an incidence of in-stent restenosis of 10%, of five on 50 patient, one at six month and four at one year. And we are 4% of external carotid artery new stenosis. All in two patient, only in the Roadsaver group.
We are three in-stent restenosis for Roadsaver, two in-stent restenosis for Cguard, and external new stenosis only in the Roadsaver group. And this is a case of Roadsaver stent in-stent restenosis of 60% at one year. Two year follow-up,
so we compare what's happening for Cguard and Roadsaver. We see that no relation have been found with the plaque activity or the device. If we check our result, even if this is a small series, we both reported in the literature for the conventional stent,
we've seen that in our personal series, with the 10% of in-stent restenosis, that it's consistent with what's reported for conventional CAS. And the same we found when we compared our result with the result reported for CAS with conventional stent.
So in our personal series, we had not external carotid artery occlusion. We have 4% instance, and for stenosis while with conventional CAS, occlusion of external carotid artery appear in 3.8% of cases.
So, what can we add to our experience now in the incidence, if, I'm sorry, if confirmed by larger count of patient and longer study? We can say that the incidence of in-stent restenosis for this new double-layer stent and the stenosis on the external carotid artery,
if not the different for all, with what reported for conventional stent. Thank you.
- Thank you, thank you, colleagues. These are my disclosures, we had some support from MEDISTIM for another study comparing duplex ultrasound and angiography intraoperatively. So, if you look at the literature, what are the reasons for perioperative strokes
in carotid surgery, most of them are related to technical errors and only a minority is related to cardiac embolism or hemorrhage. The rationale of intraoperative carotid imaging at the end of the procedure is, of course,
to document the perfect morphological result with an assumed small risk of any thrombosis or embolism. And if you early detect such lesions here, like in this case and corrected immediately, there's a strong belief, at least, that the numbers of perioperative strokes will be reduced.
Ultrasound is a newer alternative available for a couple of years, now. This is how we do the intraoperative angiography. After having completed our carotid reconstruction, it's just a punch and then a line and doing an angiogram and a second series
then also with an open external covered artery. It goes very quick in a couple of minutes. Can you move on please? I'm sorry, I'm not, so ultrasound is the second option. We make use of the VeriQ c system from MEDISTIM, where you can make flow measurements as well,
and duplex ultrasound by B mode or color mode, and you can also measure the peak and other velocities. If you have such a result, you're pretty sure that everything is okay. It's not working here. If you see these signs kind of clotting,
and recall, ask characters related to this, then you can be pretty sure that this is a technical problem. This is the distal edge after an incomplete eversion endarectomy and that was a thrombus inside the reconstructed artery.
So we looked at guidelines, and the newest version of the European guidelines tell lots of targeting, monitoring, and quality control searches may be considered to reduce the risk of preoperative stroke. It shows the 2B recommendation level C, and this is due to a lack of hat to hat comparison.
There are lots of paper in the literature where the revision rate's between three and 8%, different revision criteria and no randomized trial. So the evidence is pretty week. We decided to take a look at the national uptake of intraoperative completion studies in Germany,
and first step we looked at the annual reports of the quality assurance regulatory and saw that the number of intraoperative examination has increased over time, and parallel the in hospital stroke and death rate have decreased so we took a closer look
and looked at all the data, in collaboration with the authorities and with the institute who has all the data and looked at more than 140 thousand individual operations. 67% of the cases angio or ultrasound was done. And you see here the local anesthesia
and antiplatelet therapy perioperatively was positively associated with a reduced risk, where carotid endaretomy without patch was not, most importantly, intraoperative completions studies, like angiography or ultrasound, were both independently associated with better outcome.
So routine intraoperative imaging from my point of view is a must, there's no doubt about that, because you can detect major technical errors and correct them immediately. It is also a valid documentation of the technical result,
and by the way, in endovascular therapy, nobody, nobody would question a final look at the end result. This is part of the procedure and should also be the case for surgery. Even Playmobil has realized that,
and we shouldn't forget it's not just to know this, but the brain, some people think different. I hope my opponent is on my side at the end of the day, trust but verify. This was the saying of President Ronald Reagan in the context of nuclear disarmament,
and I would, do not trust the vascular surgery unwilling to verify a surgical end product if the brain is the target organ. Thank you very much for your attention.
- So again, I'd like to thank Dr. Veith for the opportunity to participate in this interesting debate. So, I have been tasked with the position Intra-operative Completion Study is not mandatory, and in fact I will show you why a selective approach will actually provide better results for our patients. These are my disclosures related to ongoing
clinical research and clinical trials. So again, Professor Eckstein and his colleagues should be very significantly commended for getting the entire German vascular surgery community to look at their data in a very rigorous fashion. However, both he and his co-authors will acknowledge
within the manuscript that there are significant problems with this database. A very large number of 142,000 elective carotid endarterectomy procedures with very ballotable stroke and death rates of 1.4 and 2.5%. However, a typical criticism from outside the
vascular surgery community, these are all self-reported. These are not 30 day outcomes, they're actually in-hospital outcomes. And while in Germany that still may be four days, it's not the 30 days that we see. I'll show you a little bit later on within the Crest data.
And interestingly, within their own manuscript only 50% of the patients actually had neurologic assessment both pre- and post-procedural. So, how can we make a relevant decision in terms of thinking about how we're going to treat these patients if we only have neuro data on half of them.
Lets for the moment assume we can call out those patients. How does this relate to clinical practice? Well the authors also admit that this is an observational study, and that even though there is some association, there clearly is no causal relationship
as my previous debater just admitted. And in fact, they argue that this is perhaps the best method to look at generating hypotheses for future randomized trials, much like Dr. Aborama has done with the use of carotid endarterectomy with patching. So, let's look a little bit more about the data
and see how relevant it is to your current practice. So in the Germany registry, a quarter of the patients are treated under local anesthetic. 40% have no type of neurologic monitoring, and over 40% are performed with aversion endarterectomy. Very, very different than the practice that we see
in our institution, and in the New England region. And I would argue that there's a lot of concern in terms of what the indications are for monitoring, what the indications are for shunt use. Again, that's 43%. But there's absolutely no data in this registry about
indications for shunting, when it was used, or when patients were re-explored and what they found at the time. And a little bit concerning is in 17% of the patients, there was no anti-platelet agent used in patients undergoing carotid endarterectomy.
And, I would argue that that number is just a little bit high. How about when we go to the univariate analysis? Once again, we see that there's a benefit of 0.4% decrease in stroke and death for a local anesthetic, although we are well aware that there are numerous other
perspectives that have looked at this and not shown that same relationship. Again, there's a benefit for aversion endarterectomy, but I would argue at least in the New England region and perhaps in the United States except for select centers, aversion endarterectomy is used the minority of the time
and that in fact is an indication in my mind to have a lower threshold for either angiogram or completion duplex. Most concerning, there was 0.3% difference in the stroke and death rate with the lack of an intraoperative completion study, but there was no data about indications, findings,
whether that resulted in an intervention, or what the result of that intervention was. And initially in the univariate analysis, neuro-psyche, physiologic monitoring was protective, but later on in the multivariate, it was not. Here is that same multivariate analysis that shows again
that in fact shunting and neuro-physiologic monitoring are increased risk factors for stroke. Certainly there's going to be some bias. My concern is I'm not convinced the authors are able to call out the co founding variables, even in their multivariate regression analysis.
And in fact, in their concluding paragraphs they state there's no information supplied on whether intraoperative completion studies caused an operative revision or not, and no information about cause of death. In fact, they don't even have information about
intraoperative heparin or protamine application. So I would argue I'd be very skeptical about making my final decisions based on this. Thinking about the technical aspects of angiography, there's no doubt that this is very helpful at times, but think about the details of where do you put the needle.
What type of imaging? Is it a C-arm, is it a flat plate? Who interprets it, and what are your thresholds for intervention? So, it certainly may be harmful, may be unnecessary, and may even give you false positives.
Similarly with Completion Duplex studies, there certainly is a false positive rate and then there's risk for re-clamping. I reached out to my friend and colleague Braglol to see if there was any data from Crest that would help us, and unfortunately other than the fact that stroke happens
up to 30 days after our initial endarterectomy, there was no data supporting that. So, perhaps the best study that we have is our current practice in New England where we had 6,000 patients, a third of whom received completion studies. We broke this down into rare, selective, and routine
duplex or angio studies. And in fact, in the selective group we had a very low rate of re-exploration versus the other group, and a much lower incidence of overall stroke and death. In fact, the only benefit that was statistically significant was a decrease one year rate of re-stenosis.
So in conclusion, I would argue that this is probably unnecessary, and in fact maybe harmful. Meticulous technique, intra-procedural monitoring with selective shunt use, and continuous wave doppler use may, in fact, be the way to go. But this does give us an opportunity for prospective,
randomized trial as part of another study to look for completion study indications. Thank you very much.
- That's a mouthful, thanks Dr. Morris, it's intimidating to step in front of a Dr. Parodi, but we'll go ahead. Thanks, Dr. Veith, for the opportunity to present an update of some information that we provided last year at this meeting and I'll just make note that the findings are now out to 13 years and not 12 years that are listed in your program.
So, no disclosures. So, there are different ways to look at carotid stenting and carotid endarterectomy. Question, we've heard a lot about RCTs and population-based data and both of them have advantages and disadvantages.
Recent RCTs suggest that CAS is non-inferior to endarterectomy, however, controversy exists around the external validity around these trials, as they may be limited by a number of factors including operational and institutional selection bias and capabilities. Although there are increasing numbers of good series
looking at population-based information, long-term data is somewhat lacking and that's what we hope to provide today. So, the objective of this study, and it was performed by a number of our graduate students looking at population statistics was to compare the long-term, which is now up to
13-year outcomes of patients treated with endarterectomy and carotid artery stenting, during a recent decade. So the study's design is a retrospective, population-based cohort study, occurring over 13 years. It's looking at a number of linked health administrative databases in the province of Ontario, which has a population
of 13 and 1/2 million, a single-payer healthcare system and validated coding for endarterectomy, and stenting, as well as outcome measures, stroke, and MI. There is a multivariable analysis as well, but I'll be presenting the propensity score matched analysis today, where stenting was matched
with two endarterectomy patients, based on 50 covariance. So, the results, the overall cohort had over 15,000 patients. The matched cohort was successful in over 95% of the stenting patients, so stented patients were matched with two endarterectomy patients and this matched cohort
comprised over 6,000 patients. So, the matching was successful and this is just the typical table one looking at the two cohorts, endarterectomy versus stenting and just a couple things I'll bring to your attention. These patients who had a mean age of seventy,
a third of them were women, over half or just over half were symptomatic lesions which reflects the practice in our part of the world. Comorbidity scores were similar in profile with respect to coronary disease, congestive heart failure, COPD was similar between the groups.
The vast minority were redo procedures, so most of these procedures were De Novo procedures and up to half of them were urgent procedures reflecting the timeliness that is associated generally with symptomatic lesions. So, this is a visible abstract from the Annals of Surgery paper and just sort of highlights some of these matching
results, so the primary outcome was long-term stroke plus 30 day MI in death rate, so remember that composite outcome. The risk-adjusted cohort, the stenting group, had an instance of 16.3% versus 9.7% for endarterectomy and the propensity matched scores reflected similar results.
The Kaplan-Meier curves were interesting in that the lower curve is the stenting group and you can see there was immediate difference between the primary outcome variable, 13-years stroke and 30 day MI or death and a widening of the curves during the 13 years of follow up with a hazard ratio of one and a half.
When we drill down a little closer into the variables of this composite endpoint, if we look at 13 years stroke and we look at stroke less than 30 days, the difference is in favor of endarterectomy 5.8% vs 3.8%. Beyond that 30 days it's in favor of endarterectomy as well, 7.8 versus 5.9%.
With respect to death, it's similar, there's within 30 days it favors endarterectomy and beyond 30 days favors endarterectomy as well. When we look at some of the subgroups, these differences were similar irrespective of age of the patients, although there is some variability, irrespective of sex,
males and females behave similarly, similar with respect to date of the procedure as well as the presence or absence of diabetes. So, one of the questions was are there some confounders that are not being measured and that's a question of any population based study.
We do not have information on carotid lesion characteristics, hostile neck and some of the redo procedures, smoking status or lifestyle factors and much of the medication use. There also is not a standard definition for stroke or more importantly, MI, in this series
and whether they were measuring troponin rises or clinically relevant MIs is going to depend on the center that's reporting these results. Regardless, based on this data set, CAS is associated with an early and sustained 30 to 50% higher risk of long-term stroke and death.
The differences are driven by increased risks of stroke and death within 30 days and after 30 days and it's observed regardless of age, sex, carotid artery symptoms or year of procedure or diabetic history. Thank you very much.
- Thank you for your introduction. Good afternoon, ladies and gentlemen, it's my great pleasure and honor to attend this symposium again and again, and I'd like to give my big thanks to Professor Vieth and organizing committee for inviting me. There is words of propensity match
eed to analyze with this propensity matching method? As you know, there are two representative articles. In ICSS trial, they concluded CAS was higher risk compared to CEA,
but in CREST trial, they concluded there was no significant difference between two groups. These articles were randomized control trial. For example, there is a box of apple. In randomized control trial, we can select the apple like Group 1, 2, 3,
so if the sample size were not enough, the result might be different from the population. So in randomized control trial, the larger the sample size, the more representative of the population, like Group 4, 5, 6. So, to reduce the bias from the selection,
we are now using propensity matching analysis. As you can see in this slide, the propensity matching analysis provides to match similar group object between two groups. Like this propensity score matching analysis being used to balance the covariates
and mimic randomizations. So using this method, we can reduce the bias due to confounding variables. I have selected that, because we're using key words such as propensity score, and carotid endarterectomy, and carotid stent, in PubMed.
And I found 28 articles dealing the comparison between CEA and CAS using propensity score matching analysis and my article reported in 2017 was also one of them. And the majority of articles concluded that the CEA was superior than CAS, but only three articles reported CAS was comparable to CEA.
In our hospital, Samsung Medical Center, located in Seoul, Korea, we analyzed this 700 cases of CEA and 560 cases of CAS. To compare these two procedure, we selected 487 cases of CEA and CAS
using propensity score matching. The primary endpoints were rates: stroke rate, myocardial infarction, and death. Secondary endpoints were restenosis rates. In our hospital, we did CEA under the general anesthesia and carotid shunt was routinely used,
and CAS was done under the local anesthesia, and embolic protection device was routinely used. This slide shows the lists of covariates which we had balanced for propensity score matching analysis. This is a histogram of propensity score distribution,
and here the middle part of slashed line area is the matched area. In this slide, we can understand that some of the variates showed statistically significant difference before propensity score matching.
But after propensity score matching, there was no covariates showed statistically significant difference. It means, the bias between CEA and CAS group was not present, finally. The results shows the rates of any stroke, and restenosis was significant lower
in CEA group compared to the CAS group. In our analysis by simple logistic regression, the old ratios showed high risk of stroke, MI, death, and restenosis in CAS group than CEA. Same results were shown
in multiple logistic regression analysis. So, ladies and gentlemen, conclusions: in our study using propensity score matching analysis, carotid endarterectomy showed lower incidence of major adverse clinical events and restenosis rate than CAS in our single-center experience.
Thank you for your attention.
- We have sufficient opportunity for panel discussion. Please come on up to the microphone and state your name and your question. (man whispers) - Richard Bulbulia, ACST-2. Question for Dr. Forbes. I just like to ask you to convince me why your results are so different
from the randomized evidence which are designed to detect reliably and fairly differences between the two techniques. I think you're results are due to residual confounding. The second is a comment. All-cause mortality in the long-term follow-up
of such patients is not helpful. These patients are likely to die from cancer, cardiac disease, respiratory disease, which aren't going to be determined by success or failure or surgery versus stenting. - Thanks for your comments.
I wholeheartedly agree that there's advantages and disadvantages to design methodology of our CT (mumbles) population (water pours) health, population health statistics. And that any population health evaluation is only showing an association
and as additive to the information provided by our CTs. Undoubtedly, there are unmeasured confounders with respect to our study and even in the measured confounders, there's difference in reporting among centers. And one of the main issues is the definition
of myocardial infarction and the RCT obviously has the distinct advantage of describing that definition from the start, but rather than being competitive, I think the two methodologies are complimentary in helping to answer this question. So I wholeheartedly agree with your comments.
Thank you. - [Man] Dr. Berroti? - I had the same question but I have a second one. (man laughs) I'm a little confused because what Gore is doing in these bringing a new filter
and they had a wonderful flow reversal with the empire study with 2.2, 2.4 stroke mortality. With the filter, they have double. And everybody knows that if you use filters, you have more heats. And if you use filters, you have new lesions
with diffusion-weighted MRIs. So for me is hard to understand why a company is moving to an old device that probably is going to disappear. And on the other hand, everybody is now in favor, not everybody, but most of the people are now in favor of using flow reversal.
So I'm sure I'm missing something. I don't know if the panel can help me. - Who wants to take that one on (laughs)? - I won't directly answer that but I'm just going to take the opportunity to tell you that the TCAR idea of making incision in the neck
and putting all of these devices and eventually end up with a stent. Doesn't make much sense to me because if the same incision if you go a little bit higher, you can do the endarterectomy and you're done. So I think the flow reversal should be in situations
when patients cannot have CAR endarterectomy. I'm not going to wait 13 years to see the results 'cause it's obvious now that if you can make a small incision the neck and take the plaque out, that makes much more sense. Why use the eversion technique or a little patch?
It's cheaper, is safer and the last seven years we had zero stroke and zero mortalities with it. - That is your own experience but the general experience is now changing. The group of Harvard can now, I have someone here present and in my own experience, flow reversal
has better results than carotid endarterectomy. You have less morbidity, less mortality, and long-term results similar. So I think we have to pay attention to the new numbers, with the new technology. I have done the first flow reversal 19 years ago
through a small incision and I connected the carotid with the jugular vein. And I did a case in Toledo, in Spain, and Ki-ya-ra was there in the following day, he filed a patent for the new device. And I went to Modena and Ko-pi whose wife's name
was Moma. (man laughs) Was so excited that also he filed a patent. So everything now is using flow reversal and I think it's a good technique and I agree that endarterectomy is the gold standard, but in the near future we'll see some changes.
- Thanks very much. Let's go on with Dr. Evett. - I got a question for Wei (laughs). Just a couple of simple questions. So I'm just wondering what's the proportion of frail patients in the endarterectomy as side
the same in the stenting side? And why should patients who are frail have about the same risk of complications with stenting compared to the non frail? - So this is a really, look at the database of a 38,000 patients.
Now one thing I can argue, the result was a surprise to us as well, but I. One thing I can argue for patients who undergo carotid endarterectomy lots of receive general anesthesia and stenting patient really local.
Most of I do carotid stents with femoral, transfemoral carotid stenting, local anesthesia take about an hour of surgery, take a little longer. In my hands, a bit of training. Another thing, I think because of the numb, you mentioned about numbers.
So the registry from this group registry about 38,000 patients, about 4% of the patients in both group, frail and non frail group received carotid stenting. So stenting really have about 1500 patients, but they're equal in most groups.
- On the same talk may I actually that was question in my mind. With your findings, since frailing patients got a terrible result with endarterectomies and of course, they did better with the CAS, should they have nothing at all if they are symptomatic?
I was curious for your feeling. - That's, I mean, that's very reasonable. Someone who's a frail patient who are totally asymptomatic, have no evidence of cerebral ischemia. I think medical therapy is perfectly good answer for it. - Quick question for Doctors Marks and Asher.
With regard to the pseudo-occulusion or a string sign patient, and Natalie one of the angiograms you shown, showed a very nice example of an ascending pharyngeal artery. How do you differentiate that from a string sign on a duplex?
- Well the advantage of duplex is seeing gray scale images so you could and both combination of sagittal and transverse see the IC even if it's occluded. Because it's going to be a little larger at the bifurcation and then it tapers down so it's much larger than pharyngeal artery even if it's collateralization
to externally, external carotid artery. So that's the advantage of differentiating versus in geography of the IC and the branches. - [Man] Natalie, in the same follow-up. Extremely impressed with your work with Asher about using the duplex ultrasound
for many vascular procedures. My tab-mi-sed now with you turn the power doppler on the pseudo, in pseudo-occlusion or you don't see much of use for the power doppler on these cases? - We do use power doppler in assessment
of the distal IC because it has a tendency of picking up even smaller, even much lower flows. But the only thing is that the power doppler has no direction. So you still have to go on the setting as of a color. So a power doppler does pick up any wisp of movement
a little bit better than color, So it's more present. - It's a good point and a follow-up of Dr. Asher. Does anyone in the audience use duplex ultrasound-guided carotid stenting or endarterectomy? Please raise your hand.
- You guys don't know what you're missing. (man laughs) - Yes, so which means we need that message to go in a better way. Go ahead, Wes. - Just another question, I'd probably direct this to Enrico. In instances where I've explored patients with string sign,
I've found two things. One would be a very slow flow and a contracted artery. And it really is small and you have to dilate it up before you finish. The other is what I think is what turns out to be recanalization
and there's an organized thrombotic cord within the lumen. My question is have you seen that and how do you deal with it? - Absolutely. Excellent question, Wes. The beauty about the using the ultrasound,
like duplex before, you can't differentiate these two groups. The one that has an atretic, small vessel that's most probably recanalized like you said. That one will have a thick wall and a very small lumen. If the other one that's collapsed because there's no flow.
The flow is extremely low, who have a thin wall and collapsed and once you do the endarterectomy, that artery increases right in front of you. But the atretic one, the one that doesn't matter. I don't, I will not put a dilator in this very thick one, we just ligate it.
And most of these patient actually has, have very good back pressure. To a point that I'm questioning whether this patient need any procedure at all. Because we also notice that in this patient, they have an increased chance of hyperperfusion syndrome
once he's done. Those were the very long, prolonged stenosis like that for too long. So I think that we do in those patients now only the ones that are symptomatic. The asymptomatics, we leave them alone.
- [Man] Is Dr. Gray here as the last question 'cause that was something itching his gran, okay. - [Man] What was the question? - Actually I'm not sure I would like him to be here. For the younger generation also the filters pour 70 micro,
more or more, because to not impair the flow and with the new device he proposing is it has only 40 and I was curious what is the impact of this on honest to God cognitive function? He show us in term of the heads
but I was curious with that very little flow through this. Whether it would affect cognitive function for 10, 15 minutes or whatever. - Yes. - Yeah. - [Man] Another question. - Question for Dr. O-hi-dan.
In my own institution, we have sort of a difference in practice regarding carotid body tumors, whether or not you do pre-embolization. Some of the members do do that. I happen to be in the school that doesn't. And I find that the use of the harmonic scalpel
and the bipolar forcep really enables me to do a pretty bloodless resection of a large tumor without pre-embolization. I wonder if you would comment on that. Do you use those adjuncts and would you be inclined to combine that with or without embolization?
- Yeah, doctor. I am sometimes the harmonic is not available in my hospital. The, our reality is completely different from the reality of United States by economic reasons. We don't have all the tools to sometimes to do the best surgery.
So that is the reason because only embolization. We do embolization in the bigger tumors but is not frequent on a bigger tumor and harder to see. The more frequent is a more tumor, almost four millimeters, but with use of a certain technique with experience we have in my hospital.
We are young surgeons but the results are not bad. - [Man] For the sake of time, Dr. Veith gave us, you could give you that final question, please. - This is just a follow-up to Dr. Asher's point. Are you familiar with Dr. Rothweld's pooled data on the symptomatic trials where he talked
about the preocclusive lesions actually not benefiting from carotid endarterectomy and possibly because of your comment about reversal of flow. And that was in the symptomatic trials, not the asymptomatics, so is there any justification if the numbers needed to treat 125 to save one stroke
to be doing symptomatic patients with a string sign or a preocclusive lesion? - Now, excellent point but see that, you have to differentiate the ones that were recanalized from the ones that were just thin and small
that once you do the endarterectomy open up. So I think if you, some people a little bit aggressive in trying to revascularize, recanalize vessels by dilating them, by doing I think that's what gives negative results because the only difference is basically hyperperfusion syndrome,
which occur in about 10% of these patients. - [Man] This has been an excellent discussion. But I'm afraid our time is up. Like take the opportunity to thank the panel for really an excellent series of talks. - [Man] Yeah, yeah.
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