- Thank you very much (mumbling) and to the chairman. Good afternoon to everybody. We moved immediately to our topic. This is my disclosure. I would like to present you, introduce you, this new stent. They're a really MicroStent. 3.2 French system.
Very, very small, as you can see. And actually, they are available only for retrograde deployment. And very soon, we will have new devices for antegrade deployment. They are made with nitinol.
Two nitinols... Wires, sorry. My mind is, I'm getting older. Two nitinol wire, and they behave exactly as small supera. I can introduce you the case. That is a gentleman with a previous first toe amputation,
non-healing, and I previously recanalized the one month before posterior tibial artery, but this is a patient with a small artery disease. So, you can see here, the angio, this is a CO2 angio. We have a steel patent posterior tibial, but an occlusion, a long occlusion of the anterior tibial.
And you can see how poor is the vascularization in the foot. Of course, this time, the surgeon asked me to try to recanalize the anterior tibial artery, and for us, it became the new target. You can see how difficult is the progression of the wire in the middle of this black calcium
is a very severe calcificated patient. We achieve the rupture of the Asashi Astato 20 wire. So, it was fortunately, we didn't close the tip. We could remove and change in with an Abbott Command ES hook could fortunately, cross the lesion, but you can see here the balloon cannot advance completely
in this terrible calcified patient. So, we applied this technique. We (mumbling) the antegrade wire into a needle. You can see here the advancement of the wire out of the needle. And when we have in our hand the tip of the antegrade wire,
we can pull a little bit the wire in order to achieve the excess. And we can easily pull the system we have. So, after this phase, we can succeed in have a distal access. May I have the audio?
Yeah. There is no audio volume? Okay, so we achieve the retrograde. At full, that was the key. So, the balloon can come with the wire. But normally, does not work like this.
You have to do this. We put the (mumbling) in the stent (mumbling). So, we put the torca device in the proximal part of the wire very close to the cone of the balloon, the cone wire of the balloon so we can fix the torca device in the proximal part,
as you can see. And now we have one system. We have the wire fixed into the balloon, so if we pull the wire, we can pull the balloon. So, this is a system to advance in the severe calcified legion.
In the 90% of case, it work. Of course, if you fail with this system, I don't know how can we do. But after this manipulation, we could predilate successfully all the anterior tibial artery, and now we have the possibility to aggressively
prepare the vessel as we used to prepare the vessel for when we have severe calcification for a superior stent deployment in SFA. The same we used to do in the tibial vessel when we have this kind of calcification. So, I decided to predilate and dilate all the vessel
three millimeters, and the proximal part with aggressively, with a 3.5 millimeter. And you can see here, after the deployment, after the inflation of the balloon, the result was already good, but there was a residual stenosis at the osteum.
So, we repeated the inflation with a longer inflation with this 3.5 balloon, and the acute result, the acute remodel of the artery was really good. So, now the vessel is very well prepared, and if we think to the destiny of this kind of lesion,
we have to expect a restenosis or reocclusion probably due to the recoiling of the calcium, rather than a hyperplasia, or a myointimal hyperplasia. So, you can see here with a sheetless technique, we can insert from the distal access, this micro stent. It's really very clear.
It's very, very well built and projected, and so we can be very precise in the deployment of the proximal part, and you can see the pull out manipulation, but you can modulate the struts. You can pack when you need the struts in order to improve the resistance to the compression.
And you can see how good is the deployment of the stents in the proximal AT. Of course, the manipulation should be very gentle, and when we have the superposition of the two markers that the stent is completely deployed, and so we can achieve very good scaffold
all the lesion in this patient. So, after the deployment, we had a very nice acute result. Look at how good is the flow. And then we decided to continue interdistality in order to achieve some we can call outflow, which is very important.
But of course, this is a patient. We have Roberto in the panel who can be classified as a no-option patient, because the definition is we have clearly a small artery disease, and all the forefoot has no vessel. Look how difficult it was to achieve a reenter
into the dorsalis pedis after several perforation. This was my thought, but (laughs), it was really a war. At the end, you can see here the flow is exact, in the anterior, is exactly the same speed as in the posterior, but as you can see, in this patient,
the distribution system towards the forefoot is completely failed, so probably, the clinical improvement will be not so fine and not so good. But we before shift to the arterialization, of course, we tried to do our best.
You can see here again, the deployment, how clear is the deployment of the stent at the top at the proximal part of anterior tibial in another case. Very, very smooth after a very good preparation. So, again, the crucial key is to prepare very well the vessel in an aggressive way.
Our experience, we only performed seven cases. They're really very, very calcified. We lost some patient, but we checked three patients that are still patent with one occlusion. It's very encouraging and promising procedure. I really believe in this kind of scaffolding
when we have this kind of calcification. We are going to start a prospective study in order to collect more patient, of course. You can see here, this is one of the first patient perform with a very good result. And you can see here the flow in the doppler ultrasound.
So, thank you very much for your attention, and this is (speech drowned out by applause). - [Male] Thanks. Thanks, Marco. Fantastic, Ian. Any quick questions? Just a quick one.
I mean, in terms of distal preparation, can we use experience like supera with, as you say, slight over-dilating to allow it to sit unconstrained? - [Marco] Yeah, in effect, we have to try to oversize the vessel.
As Roberto used to say, the size is important, especially in below the knee. One of the main reasons of the failure of the global impact study was the undersizing of the angioplasty they perform. And when we have this kind of calcification,
of course, we have to try to crack the calcium in some way, and we have, of course, only balloon because it's difficult to think that an atherectomy device can cross this kind of lesion. So, we try to step-by-step to increase the size of the balloon and the pressure,
of course, in order to crack. And probably, probably could be one option for a better patency in this kind of patient. - [Male] Perfect. Just a quick question, Marco. Do you use a one-to-one ratio of this stent
with the (mumbling) vessel diameter? - [Marco] Yeah. - [Male] Or you use an-- - [Marco] Yes, in this case, we deploy the 3.5 millimeter stent after the 3.5 millimeter balloon angiopathy.
Of course, 3.5, it's a quite huge balloon for the proximal AT. Despite in some patient, we have to use this size of the balloon. - [Male] Okay, thanks, thanks very much, Marco.
- Thank you Mark. Those are my disclosures. Those are the usual steps you have to do to perform a fenestrated endograft, go through the fenestration into the target vessel, then push a catheter to exchange a floppy wire for a stiff wire.
So this can be quite straightforward, or it can be a bit more difficult when you have this type of ongoing target vessel such as this right renal artery here. This is one of the first tips, is actually to use the top of the fabric because of this stage
the graft is still closed and you advance, you can see here a sheath as far as possible and then use the top of the fabric and get a glide catheter to advance over the wire. And this is an example of such a procedure, you can see the catheter advancing all the way
using the top to have support from above. Now, sometime when you're doing thoracoabdominal repair, the fenestration is far from the top of the endograft so that there's no way you can use it and curl the catheter. So then you can actually inflate a coated balloon just above the fenestration to have that specific support
from above, and this is what you can see here. Now this is kind of quite a changing celiac trunk that you can see here on the left. You can see the sheath is advanced here, and then the catheter is advanced from the top, now advancing the wire in a better position
and then advancing the catheter. Next step is to actually get a balloon over a Rosen wire, through the fenestration into the target vessel and then you inflate the balloon and while deflating it, you push the sheath over this balloon and finally, this is a selective
angio after stent implantation. This was quite a challenging celiac trunk that we managed from below. Most of our fenestrated procedures are performed now with three- and four- vessel fenestrations, so you need quite a significant number of sheaths
to go through the control of the limb. Sometime it's just possible to have four 7-French sheaths to go in through one iliac, so what we tend to do, is to have two sheaths in the two renals and two just balloons, and once we're done with positioning the renal stent, we switch and put position sheaths
through the vessel. But there's an easier way of performing this procedure, is to use preloaded catheter. Here you have wire and catheter going directly through the renal fenestration so you can access the renal fenestration from the same groin,
you get the device up and then only do the visual vessel from the other side. And this is an example here, I'm working from the delivery system, you see we're using long sheath and catheter. You can see here, getting access to the right renal artery
advancing a catheter over a wire. And then next, you will see that, we'll have injected a bit of contrast in the right renal to check that we haven't dissected or to check that we're in the main trunk. And then over a stiff wire, just advanced this
6-French Shuttle sheath over the catheter and the wire. This is a way of performing a quite difficult renal artery from below. Now a new option is to use a steerable sheath, we're using the Medtronic APTUS sheath at our center. This is another example of quite a difficult celiac trunk
and you see we managed to get access and then push a stent from below using this steerable sheath. This is the selective angio and the postop CT showing a patent celiac trunk. And we've been using those steerable sheaths in ruptured thoracoabdominal, using the T-Branch.
So for those patients, don't use an externally approach. We did at every aorta from the groin, and I did this small video in the plane, to show you this is one of the latest rupture we had, the patient had a prior frozen elephant trunk, so we first had to rely on the elephant trunk with a TEVAR
and then this is opening the T-Branch here. And now this is what I wanted to show you, this is a 16-French APTUS sheath, then I'm positioning first through the celiac trunk. And you can see we can really flip the sheath inside the branch and then advance
a wiring catheter to access the target vessel. Here first the celiac trunk, obviously I do all those cases under fusion guidance, you see here a wire advance in the celiac trunk. Now this the SMA, and you see I'm changing the angulation of the APTUS sheath to actually get access to it
and from below again, easy access to the SMA and then we just advance the bridging stent. This right renal was much more difficult because it was an emergency, so you see that this graft is not well adapted to this patient anatomy, the branch is very far.
So inside the 16-French APTUS, I had to push a 7-French sheath all the way down to the origin of the renal artery. And then we managed to advance this bridging stent here. So I'm going to move forward, this is another video
from Gustavo Oderich of the Mayo Clinics, saying that if you need to come from above, you can have preloaded catheters and push them directly there. This is to show you that if you come from above, you increase obviously the stroke risk.
Another benefit of coming from below is that you protect yourself from X-ray and I think this is very important. So we have new tools, you have a pre loaded delivery system, you're better protected, and you reduce a stroke risk. So I think it's safer to come from below, I like to actually do that in a safe manner,
rather than coming from above and not really controlling everything. Thank you for your attention.
- These are my disclosures. So we all know the problems with long-term failure of EVAR and TEVAR. Type one endoleak being a particular significant concern. We've heard the results of the three year ANCHOR Registry. We know from this 85% of those cases taken on for type one endoleak were successful
and it's fantastic that these cases are still successful at three years. But I guess it's 15% failures and it's important that we talk about how we get success like this. If we're going to talk about a recipe for success we need to think about first of all the indications
for treatment of endoleaks. This is key. Not all endoleaks are the same. Those endoleaks where there's an inadvertent creation of a leak channel around the graft at the top end because of a hostile landing zone
or excessive oversiding of your graft or noncircular aorta, all can be well treated with endoanchors. Again, migration and loss of seal can also be well treated. But others where there's excessive thrombus or calcium won't work and where there's insufficient apposition between the graft and the aorta, again,
this is not a treatment case for endoanchors. So intraoperative type one endoleaks where there's poor conformability of the graft you can see here this barrel-shaped neck, there's a leak around the aorta, and there's a series of endoanchors
placed in rows circumferentially, do really well to seal up that. You can do the same at the distal end of the thoracic graft as we've just seen in those conical necks when you have a type one endoleak. If you have time to treat your leak channel,
you want to get a CT scan and evaluate where that leak channel is. Or you can do more detailed imaging with triangulation on angiography, but that's difficult. You fix the side away from the endoanchor first,
and then fixing rows of staples along the endoleak channel as you can see here, by moving the C-Arm in 15 degree increments across the aortic wall. This is a good example of a case with a leak channel. This graft is in the angulated aorta
with a channel underneath in the bottom end. There's a big endoleak there. And what we've done is fix the contralateral side first and then you're placing a series or rows of endoanchors underneath the stent graft. You can even zipper that up to change the bird beaking.
And that endoleak stayed sealed for three years. The same is true in the proximal thoracic aorta. This is one of Firas Mussa's cases. There's an endoleak on the underside of the arch and five endoanchors placed on the underside of the arch as we've just seen in JP's talk,
can resolve that endoleak quite successfully. When you are doing it in the arch you do need to plan properly. If you have an endoleak at the end of the case what you can do is put the C-Arm in an LAO position and line up the markers on the graft,
place the superior and inferior endoanchors and then rotate cranially and caudally at 15 degree intervals to put a series of endoanchors at the superior and inferior surfaces. That will fix the graft well. Otherwise, if you've got time and plan the case well,
you can work out dedicated C-Arm angles using one of the CT evaluation softwares. The best example is written by Rousseau, and I would get you to read that article to learn further. And that's how I learnt. There is a learning curve.
And this is necessary for success in treating type one endoleaks. You need some experience to gain good endoanchor placement. That's crucial, we've heard that. Start with the infrarenal segment, doing prophylactic cases,
the conical necks and slightly dilated necks, and then move into the thoracic segment. You need to use different size guides for different parts of the arch. On the upper surface the smaller guide is more useful. On the undersurface a larger guide to place the endoanchors
on the under surfaces of the arch is useful. Place them in rows coming back and have some patience. It's not all as easy as it looks right up there in the arch. For migration it's often an excellent strategy. If you can fix your migrated endograft to the native neck it's a good thing to do.
But remember these grafts have migrated and there's often great tortuosity there. If you can extend to gain a seal zone and then place a series of circumferential endoanchors it will fix that well and usually stay fixed for a good period of time.
There are limitations as I alluded to in the first few slides, excessive thrombus, excessive calcification, and where the aorta is dilated excessively and the endograft has stayed the same size. These will not work with endoanchor placement.
These are my tips, really, for success. There is a learning curve. Start with some easier ones. Think about the endoleak and why you've got an endoleak and don't be tricked into thinking the endoanchors will create a landing zone for you.
It won't. You should treat the type one endoleak immediately if you have it at the end of the case with re-interventions. You need to target that effectively and place multiple rows often cranially and caudally. And if you have one of the 13.4% failures,
remember that the use of endoanchors doesn't preclude you from doing something else so don't be too depressed. Thank you very much.
- So, this is a prerecorded case. This is my disclosures. Well, we've all seen the concept of Percutaneous Venous Arterialization and this was discussed several sessions ago in the main hall of going crossing from an artery into vein and having multiple stent step would re-line the
venous wall and take away the valves and to bring blood to the capillary bit. Quickly, this is the animation of what goes on. An antegrade seven french sheath, a retrograde five french sheath. An ultrasonic system with alignment between the
artery and the vein and then a needle is driven, wired, pre-dilatation. The use of a 4 french valvulotome to cut the valves in the foot, to de-valvulotomize the valves and then after that, align the whole vein with a covered stent
to do an endovenous bypass. So, this is a prerecorded case courtesy of Dr. Daniel van Den Heuvel, an Interventional Radiologist out of Netherlands. So, this is a 70 year old lady with ulcer in the first and the fifth toe, Rutherford five.
Diabetic, hypertensive and failed conventional intervention. So, I'll start the video right now. Could we have volume please? Yeah, thank you. - Okay. (beeping) - Feel free to ask any questions.
I can pause the video. - [Doctor] So, we see proximal occlusions of the tibial vessels, and all collaterals going down to the foot. So, no direct target vessel for revascularization. So we apply the tourniquet with an Esmarch.
- So now, he's actually getting venous access at the-- - (mumbles) in the vessel. - Retro (mumbles) area. - Gently past the probe. Okay, so now the-- - I'll just pause over here. This is the device with the retrograde five french sheath
and the five french catheter, and the antegrade device that allows you to cross over an artery to the vein, and this is properly aligned in this case. - [Doctor] Marker of the arterial probe is at the same level as the venous probe. Let's fix it with a wet gauze, please.
And then, let's fix it and connect the arterial probe. So, I think this is the maximal-- - So, the ultrasound system allows a predictable crossing between an artery and the vein. - [Doctor] Feed and retract the venous probe. So, leave the sheath in while they are about
to retract the venous probe. Maybe, yeah. Also, pull down the sheath a little bit. - After alignment, the one probe is removed to give space for the crossing. - [Doctor] Yup, okay.
To puncture with a needle, you need to turn the device to unlock it and then advance it. Yeah. So, I unlock it. Okay. Yeah, this, see some contrast.
So, at the same time, we'll do the puncture with the needle. - That was quite subtle. You could see the needle push against the vein wall and it went right through the vein wall. - [Doctor] And then see what happens. - And, now, with an over the wire system,
you're able to introduce a wire. - [Doctor] It's in right away. - You know you're in the vein because of the appearance of the wire abutting a valve. - [Doctor] We can try to correct for that in the later stage.
- So, now, with a support of a CXI catheter, he's trying to catheterize the appropriate vein. - This is probably the right (mumbles) so. Okay, so this is the right one, so we crossed in the middle.
So, now, again, we go distal and lead gently. Try to, aha! Now, we're in the sheath. Okay, false.
Try for several times. If not, then-- So, okay, so probably now, already past the puncture point. Be gentle, just wait for the valve to open and not to push too much.
- So, the next step is to cross the valves and this maneuver is usually done with a variety of wires and the main thing that you need is actually patience. - Don't go too far (mumbles)-- - So, this could be supported with a balloon or a CXI catheter or any other catheter. - Yeah, okay.
Okay, and the wire is better. But, is it the right one? Yeah, okay. - The tourniquet is still on that you have gauzes or is it-- - Usually, at this point, after the crossing, you can actually take the tourniquet off, so--
- [Professor] The contrast is staying here in the-- - Yes, I think he probably injected some contrast through a superficial vein to maybe give a better visualization of the anatomy. So, I think, in this case, probably there was some either the tonic,
it wasn't off, or he injected some contrast. It can be useful. You know, it's not harmful to the patient. - [Doctor] Vein we're targeting, so. Now, we should be able to cross the-- - So, there are plenty of valves
in the foot. - The feet arch. - There's usually one in the mid area here. So, he was able to cross this. And then, after that, you're able to cross the venous arch with no problems because it's not diseased as like the arterial arch.
So, fairly predictable pattern of, very much similar the arterial system is in this case. - [Doctor] So, now, you open up the valvulotome. Close the two E again. Now, you can do like forward cutting with the valvulotome
It has, you see, and we know where there are valves here. You see the tapering of the valvulotome and now it's open. - So, when the valvulotome engages a valve, maybe I can double back a little bit. - [Doctor] Now it's open.
- A little bit more. - [Doctor] Forward cutting with the valvulotome. - So, when the valvulotome engages the valve, you can see a nearing of the valvulotome and then suddenly there's a jump and then the valve, the valvulotome opens up again.
- [Doctor] The valvulotome and now its open. - That's it. So, that's the typical appearance of how a valvulotome would cut the valve and we would rotate the valvulotome and cut it in multiple locations.
And then, the, this is implantation with a stent and we would generally avoid the bifurcation of the medial lateral plantar vein. So, this stent is a 5.5 millimeters at the bottom end. And, a tapered stent on the top. Maybe I'll just quickly--
- [Doctor] No more space, so I will just-- Dip finish. - Move up, so as he's continuing to stack up the stents-- - [Doctor] Preparing some, yeah. - And then, do an angiogram. You can see the area that you want to cross.
- [Doctor] So, now we can clearly see the ostium of the posterior tip. So, I want to stay distal of that. - So, this is done from a 3.5 to a 5.5 stent to make sure that we don't cover the origin of the perioral artery to prevent ex--
Occlusion of the collateral. - [Doctor] Do a longer inflation, so we have to five balloon again. - And post dilatation is done and-- - Okay. - In this case. - [Doctor] Yeah.
Four millimeter or a five. - This is done with a five. This looks like a five millimeter. Basically, to essentially rupture the vein, the vein is only serving as a conduit and after that, the stent is able to expand. So, this is a very nice picture
of good flow-- - It's nice. - No residual stenosis and good flow up the arch as well. And then, at the proximal end, I believe, he probably did some post dilatation as well. - [Doctor] Okay, here. - And sometimes, we do add on a (mumbles)
stent if the vessel is diseased on top, you know, but I think not in this case. In the proximal end, very good flow. Over here, the origin and-- So, this patient, pre-procedure, had gangrene over the tip of the toe and after that,
the gangrene had healed and on this site, not sure if this is gangrene or just a nail infection, but we know it got better and you can see that the foot is visibly different between before and after the procedure. It always look a little bit swollen,
but swelling has never become a major issue on a chronic phase. We haven't had patients come back with venous ulceration or anything along those lines. So, with that, I'd like to thank you. And this is a 3-D rotational angiogram
of, not a CT scan, rotation angiogram of what it looks like after the procedure. Thanks. - [Man] Fine. (applauding) - [Professor] Thank you, Steven,
for this great presentation, a really fascinating technology. I have a small question over-- - Yes, Professor. - What about digital arteries? Because in your picture, I never saw the digital arteries
after the bypass. - Yeah, Professor, that's a very good question and this is a problem that we continue to grapple with and we find it's seems to be unable to be solved because there are valves at the metatarsal and digital veins that go into the, to the toe.
And, one of the shortcomings of this procedure, it seems that we are unable to push the blood as distal as we want to push like a conventional angioplasty. So, I'm not sure if we're able to circumvent this for the future because, as you know,
the veins in the foot and the toes are really really very small and prone to spasm and very high restenosis. So, in the future, if we're able to bring the blood forward instead of a fly by across the foot, you know, like a conventional angiogram,
this may hold a future for what we're doing. But, until now, we don't really have something like that. What we can do and what Roberto has done is to focalize and to selectively pressurize the flow forward with a selective embolization of large collaterals like the great saphenous vein
or even surgical ligation. But, this is, you have to do it very gently 'cause if you, if you take away these outflows, then there's a risk of thrombosis, but if you have too many outflows, then the blood does not reach the foot in front,
you know, so this could be a potential for studies in future. Maybe pressure monitoring or something along that line. Yeah. - And what about the patency? - The patency?
Well, the patency is not very good in this procedure, as I must confess, you know. We do have re-intervention for this procedures, but a re-intervention is actually quite simple if you are able to survey it, mostly like a bypasses in the distal end.
So, one wire, one drug coated balloon would usually solve the problem if you detect it before thrombosis. If you do have thrombosis, then it's going to be a problem because it's like a bypass. You have to use a Rotarex disc, that's been my experience,
to clean up the whole graph. Quite quick and then do a bit of thrombolysis to clear the clot that's in the veins and certainly the secondary patency is not so good if the, if the veins all thrombose because with thrombosis,
the veins have a intense scarring and inflammatory process, so I find that the benefit of re-intervention early is much better in terms of the clinical as well as the angiographic outcome and the perfusion as well.
So, surveillance like how you would survey for a distal bypass and treat the stenosis early. - It's Lisa. (mumbles) - Okay, thank you very much for this very nice presentation.
- I want to thank the organizers for putting together such an excellent symposium. This is quite unique in our field. So the number of dialysis patients in the US is on the order of 700 thousand as of 2015, which is the last USRDS that's available. The reality is that adrenal disease is increasing worldwide
and the need for access is increasing. Of course fistula first is an important portion of what we do for these patients. But the reality is 80 to 90% of these patients end up starting with a tunneled dialysis catheter. While placement of a tunneled dialysis catheter
is considered fairly routine, it's also clearly associated with a small chance of mechanical complications on the order of 1% at least with bleeding or hema pneumothorax. And when we've looked through the literature, we can notice that these issues
that have been looked at have been, the literature is somewhat old. It seemed to be at variance of what our clinical practice was. So we decided, let's go look back at our data. Inpatients who underwent placement
of a tunneled dialysis catheter between 1998 and 2017 reviewed all their catheters. These are all inpatients. We have a 2,220 Tesio catheter places, in 1,400 different patients. 93% of them placed on the right side
and all the catheters were placed with ultrasound guidance for the puncture. Now the puncture in general was performed with an 18 gauge needle. However, if we notice that the vein was somewhat collapsing with respiratory variation,
then we would use a routinely use a micropuncture set. All of the patients after the procedures had chest x-ray performed at the end of the procedure. Just to document that everything was okay. The patients had the classic risk factors that you'd expect. They're old, diabetes, hypertension,
coronary artery disease, et cetera. In this consecutive series, we had no case of post operative hemo or pneumothorax. We had two cut downs, however, for arterial bleeding from branches of the external carotid artery that we couldn't see very well,
and when we took out the dilator, patient started to bleed. We had three patients in the series that had to have a subsequent revision of the catheter due to mal positioning of the catheter. We suggest that using modern day techniques
with ultrasound guidance that you can minimize your incidents of mechanical complications for tunnel dialysis catheter placement. We also suggest that other centers need to confirm this data using ultrasound guidance as a routine portion of the cannulation
of the internal jugular veins. The KDOQI guidelines actually do suggest the routine use of duplex ultrasonography for placement of tunnel dialysis catheters, but this really hasn't been incorporated in much of the literature outside of KDOQI.
We would suggest that it may actually be something that may be worth putting into the surgical critical care literature also. Now having said that, not everything was all roses. We did have some cases where things didn't go
so straight forward. We want to drill down a little bit into this also. We had 35 patients when we put, after we cannulated the vein, we can see that it was patent. If it wasn't we'd go to the other side
or do something else. But in 35%, 35 patients, we can put the needle into the vein and get good flashback but the wire won't go down into the central circulation.
Those patients, we would routinely do a venogram, we would try to cross the lesion if we saw a lesion. If it was a chronically occluded vein, and we weren't able to cross it, we would just go to another site. Those venograms, however, gave us some information.
On occasion, the vein which is torturous for some reason or another, we did a venogram, it was torturous. We rolled across the vein and completed the procedure. In six of the patients, the veins were chronically occluded
and we had to go someplace else. In 20 patients, however, they had prior cannulation in the central vein at some time, remote. There was a severe stenosis of the intrathoracic veins. In 19 of those cases, we were able to cross the lesion in the central veins.
Do a balloon angioplasty with an 8 millimeter balloon and then place the catheter. One additional case, however, do the balloon angioplasty but we were still not able to place the catheter and we had to go to another site.
Seven of these lesions underwent balloon angioplasty of the innominate vein. 11 of them were in the proximal internal jugular vein, and two of them were in the superior vena cava. We had no subsequent severe swelling of the neck, arm, or face,
despite having a stenotic vein that we just put a catheter into, and no subsequent DVT on duplexes that were obtained after these procedures. Based on these data, we suggest that venous balloon angioplasty can be used in these patients
to maintain the site of an access, even with the stenotic vein that if your wire doesn't go down on the first pass, don't abandon the vein, shoot a little dye, see what the problem is,
and you may be able to use that vein still and maintain the other arm for AV access or fistular graft or whatever they need. Based upon these data, we feel that using ultrasound guidance should be a routine portion of these procedures,
and venoplasty should be performed when the wire is not passing for a central vein problem. Thank you.
- [Bill] Thank you Vikay. I think this is an interesting topic for many reasons but one of the key ones is that if you look at our health care policies by insurers, this tends to define our practice. So I looked at BlueCross BlueShield's policy and they say that treatment of the GSV or SSV
is medically necessary when there is demonstrated saphenous reflux and I looked for more and there was no more. That's all they said so they must think that reflux a time correlates with venous severity. So is this true?
I think, personally, that there are other things that are involved and that volume is really the key. Time, velocity and the diameter of the vein are likely all part of the process and we all know that obstruction
is also critically important as well and probably the worse patients are those that have both reflux and obstruction. Probably reflux is worse in the deep system but we know that large GSV and SSV patients can develop CEAP four to six symptoms
and do very well with saphenous ablations. And I think this is a nice analogy. I love this guy, it looks like he came off of his lawn chair to help the firefighters out but he's probably not going to do so much with his little garden hose now, is he?
So I think size and velocity do matter. What does the literature tell us? Chris Lattimer and his group have done an elegant set of studies looking at how various parameters correlate to air plethysmography and venous filling times. They did show that there is a correlation
between venous filling time and reflux time. However, other things were probably more correlated such as GSV diameter and reflux velocity. And in this nice study of 300 patients they found that there was a relatively weak correlation between reflux time and clinical severity
and their conclusion was that it was a good parameter to identify reflux but not for quantifying the severity. So here's how we use this clinically in my practice. So you see many patients such as this that have mixed venous disease.
53-year-old female, severe edema. You do her studies and she's got reflux in the deep and the superficial system. So how to we decide if saphenous ablation is going to help this patient or not and correct these symptoms, prevent further ulcerations?
So all reflux is not created equal. The top is a popliteal tracing where the maximum reflux velocity is about five centimeters per second versus the bottom one that's about thirty to forty centimeters per second
so these probably aren't going to behave similarly in when we look at them. So we studied this in 75 patients and reported this back in 2008. We look at the maximum reflux velocity in the popliteal vein to tell if these patients
would improve after we ablated their saphenous or not. We found that this was a significant predictor of both improvement in venous filling index and the venous clinical severity score so we think velocity really does matter. And this is where we're seeing this clinically.
This is a patient that was referred to me for a second opinion concerning whether she would need ablation of her great saphenous vein. And this is the reflux tracing and you can see the scale here is turned up so that this is a measurement of reflux at about two centimeters per second.
This was used to document abnormal reflux and to justify ablation of the saphenous. So I checked one of our tracings. This is what it looks like.
- [Sergio] Good morning everybody. I really do thank you for the opportunity to reason with you about the lower limbs venous kinetics and the consequent impact on drainage direction. I have no conflicts of interest to declare, particularly because this talk is all about physics and about those laws of physics
that rule the venous drainage. We could say that the drainage occurs along our Italian leg, along a deep venous highway, a saphenous freeway and along several tributary and perforated roads.
But we could also say that we could divide the anatomy of our lower limb into three different compartments. So the tributary one's above the fascia, the saphenous one in between the fascia layers, and the deep venous one below the fascia. In this kind of network, talking about physics,
we could apply the Bernoulli's principle which, to make it simple, states that whenever there is an acceleration, a lateral pressure drop occurs. Which introduces the Venturi's effect as a potential aspiration of blood
from a slowest toward a fastest vessel. But actually, up to now, we couldn't say this for sure and say that venous network because we have really few data on the literature about the velocity values that we have in the different segments of the different compartments.
So the aim of this investigation, in the first physiological part, was to evaluate the different velocity values of different segments, understanding if the Venturi's effect could be applied inside this network, and then looking at the pathological cases.
So we have 36 lower limbs of healthy controls, and we assess all the velocity segments in the different segments of the three different compartments, evoking the flow both by active dorsal flection maneuvers of the foot, and by compression/relaxation
of the calf of course. So we compared all the different values of all the different velocities with the two different maneuvers, and we created several tables and we performed several statistical tests to see
how these velocities were behaving in the different compartments. So it's pretty interesting to notice that there are segments of our venous networks in which if we are performing the vocation of the flow with two different maneuvers, we are going to have
significantly different values of velocity. So for example, this happened in the external iliac vein, in the femoral vein, in the posterior tibial vein, and the tributary veins. If you look at the graph, we realize that there is a gradient of velocities
that is decreasing in physiology. While we are moving from the deepest, toward the most superficial compartment. And if we take all these velocities we assess together, we see that there are three different groups of velocities basically, statistically speaking,
that almost totally overlap the anatomical compartments, with some exception. So if you look over here for example, you have the posterior tibial vein that belongs to the deep venous system of course, in terms of anatomy, but not in terms of velocities.
Which means that the velocity we reported were significantly different from the ones belonging to the deep venous compartment. The same thing for the short saphenous vein, which demonstrated to of course belong to the saphenous compartment in terms of anatomy
but not in terms of velocities. If we move toward the pathological part of this, and we look at the 40 chronic venous disease patients we assessed in a model in which we considered incompetent tributary as the segment you see over there, depicted as C.
Compared to the adjacent GSV trunk, A and B. It's interesting to notice how the peak diastolic velocity and the diastolic time average velocity are actually significantly higher in the tributary compared to the GSV in pathological cases.
And if we look at the resistance index, it's interesting to notice how the segment in B, so the GSV trunk below the confluence, is actually higher. Like indicating a sort of preferential road of drainage toward the incompetent tributary.
This introduced the Venturi's effect, so now we can see the Venturi's effect could play a role inside the venous network. In physiology with a gradient that is increasing in terms of velocity, so potential aspiration while we are going toward the deepest compartment.
And the gradient that is subverted in pathology, where we have tributaries that are going faster when they are incompetent, compared to the GSV trunk, so leading to potential aspiration. But our blood is not a newtonian fluid, our vessels are not ideal conduits,
so we have to admit some things we know that we know, and that's of course the newtonian physics. Kn we know that we don't know,
and that's the application of the newtonian physics inside the human body. And then unkn things we don't even know that we don't know. That's the in-vivo validation
of these physical models. Independently by what we know and by what we don't know, I totally agree with profe tters and starting from today we know that Venturi's effect could play a role inside the venous network. Thank you.
- Good afternoon to everybody, this is my disclosure. Now our center we have some experience on critical hand ischemia in the last 20 years. We have published some papers, but despite the treatment of everyday, of food ischemia including hand ischemia is not so common. We had a maximum of 200 critical ischemic patients
the majority of them were patient with hemodialysis, then other patients with Buerger's, thoracic outlet syndrome, etcetera. And especially on hemodialysis patients, we concentrate on forearms because we have collected 132 critical ischemic hands.
And essentially, we can divide the pathophysiology of this ischemic. Three causes, first is that the big artery disease of the humeral and below the elbow arteries. The second cause is the small artery disease
of the hand and finger artery. And the third cause is the presence of an arterial fistula. But you can see, that in active ipsillateral arteriovenous fistula was present only 42% of these patients. And the vast majority of the patients
who had critical hand ischemia, there were more concomitant causes to obtain critical hand ischemia. What can we do in these types of patients? First, angioplasty. I want to present you this 50 years old male
with diabetes type 1 on hemodialysis, with previous history of two failed arteriovenous fistula for hemodialysis. The first one was in occluded proximal termino-lateral radiocephalic arteriovenous fistula. So, the radial artery is occluded.
The second one was in the distal latero-terminal arteriovenous fistula, still open but not functioning for hemodialysis. Then, we have a cause of critical hand ischemia, which is the occlusion of the ulnar artery. What to do in a patient like this?
First of all, we have treated this long occlusion of the ulnar artery with drug-coated ballooning. The second was treatment of this field, but still open arteriovenous fistula, embolized with coils. And this is the final result,
you can see how blood flow is going in this huge superficial palmar arch with complete resolution of the ischemia. And the patient obviously healed. The second thing we can do, but on very rarely is a bypass. So, this a patient with multiple gangrene amputations.
So, he came to our cath lab with an indication to the amputation of the hand. The radial artery is totally occluded, it's occluded here, the ulnar artery is totally occluded. I tried to open the radial artery, but I understood that in the past someone has done
a termino-terminal radio-cephalic arteriovenous fistula. So after cutting, the two ends of the radial artery was separated. So, we decided to do a bypass, I think that is one of the shortest bypass in the world. Generally, I'm not a vascular surgeon
but generally vascular surgeons fight for the longest bypass and not for the shortest one. I don't know if there is some race somewhere. The patient was obviously able to heal completely. Thoracic sympathectomy. I have not considered this option in the past,
but this was a patient that was very important for me. 47 years old female, multiple myeloma with amyloidosis. Everything was occluded, I was never able to see a vessel in the fingers. The first time I made this angioplasty,
I was very happy because the patient was happy, no more pain. We were able to amputate this finger. Everything was open after three months. But in the subsequent year, the situation was traumatic. Every four or five months,
every artery was totally occluded. So, I repeated a lot of angioplasty, lot of amputations. At the end it was impossible to continue. After four years, I decided to do something, or an amputation at the end. We tried to do endoscopic thoracic sympathectomy.
There is a very few number of this, or little to regard in this type of approach. But infected, no more pain, healing. And after six years, the patient is still completely asymptomatic. Unbelievable.
And finally, the renal transplant. 36 years old female, type one diabetes, hemodialysis. It was in 2009, I was absolutely embarrassed that I tried to do something in the limbs, inferior limbs in the hand.
Everything was calcified. At the end, we continued with fingers amputation, a Chopart amputation on one side and below the knee major amputation. Despite this dramatic clinical stage, she got a double kidney and pancreas transplant on 2010.
And then, she healed completely. Today she is 45 years old, this summer walking in the mountain. She sent to me a message, "the new leg prostheses are formidable". She's driving a car, totally independent,
active life, working. So, the transplant was able to stop this calcification, this small artery disease which was devastating. So, patients with critical high ischemia have different pathophysiology and different underlying diseases.
Don't give up and try to find for everyone the proper solution. Thank you very much for your attention.
- Thank you again, Dr. Veith, for the kind invitation to talk about this topic. This year, these are my disclosure. In the last five years, we treated 76 cases of Fenestrated and Branched repair for torque abdominal unfit for open surgery. And we soon realized that the upper extremity access
is needed in almost up to 90% of the cases. The first cases were managed by standard cut down in high-brachial and brachial region, but as soon as we improved our skills in percutaneous approach for the groins, we moved also in a transaxillary and percutaneous access
in the area. What we learned from the tanvis group of Hamburg is that the best spot to puncture the artery is the first segment, so the segment within the clavicula and the pectoralis minor. And to do so it is mandatory to use an echoguidance
during the procedure. Here you can see how nicely you can evaluate your axillary artery and avoid puncture the artery through the pectoralis minor where there are nerves and collaterals and also collaterals of the vein. Here is short video you can see I'm puncturing
the axillary artery just below the clavicula with a short guide wire, we introduce 6 French sheath and then we place two proglides according to the instruction for use of the device for the femoral artery. And at the end we usually put a 9 French short sheet
and then we start the procedure. As soon as we are finished with the main body of the, finished with the graft and we have bridged all the vessels from below, we downsize the femoral access but we keep in one groin a 7 French sheath
in order to perform then the final closure. What we do as soon as we are finished the complete procedure we snare a wire from the femoral artery we push the seven French sheath in the axillary artery, we pull back the 12 French sheath in the axillary artery and then we are ready to unlink the two sheath
and so we push a wire in the axillary, from the axillary in the aorta, and one wire in the arm. So that we can deploy a balloon which is sized according to the axillary artery diameter we inflate the balloon and we remove the 12 French sheath and now it is possible to tie the knot of the proglide
over the balloon without any worry to have bleeding and we check with the wire then we remove the wire and then we tie the know of the proglide again. And we ensure that there is no defect and leaking on this region. We have done so far 50 cases and they are
enrolled in this study which is almost completed. And here you can see the results. We have mainly punctured the left side of the axillary, you can see that nicely the diameter of the axillary artery in this region is 8.9 millimeter the sheath size was mainly the 12 French
but we also use sometime the 16 in cases which on iliac was not available. And we also punctured the artery if there was a pacemaker or previous scar for cardiac operation. And here are the results you can see we had no open conversion, the technical success
was 92% of the cases because we are to deploy three cover stent to achieve complete sealing and one bare stent to treat dissection distally to the puncture site. We didn't have any false aneurysm on the follow up and arterial thrombosis and no nerve injuries
in the follow up. So for the discussion, if you look on the research where there are different approach in the discussion is called either to go for the first or the third segment we believe that the first segment is better because it is bigger, is more proximal
and there are no nerves in this region. And by proximalizing the approach you can also work from the right side of your patient so you don't need the guy left side of the table. Moreover, by having the 12 and the standard 19 seven french sheath you can enhance your pushability
here you can see that the 12 french sheath arrives close to the branch of renal artery and the seven french sheath is well within the renal branch. And here you can see where the hands of the operator are. Of course if you enhance this technique you can downsize contra arterial femoral sheath
needed to reach three vessels so maybe lowering your risk of limb ischemia and paraplegia and if you insert this approach in the femoral percutaneous approach, you can see that you can cut down your procedural time your OR occupation time and also
the need of post operative transfusion. So dear chairman and colleagues in conclusion, in our experience the first segment is the way to go. Echo guided puncture is mandatory. Balloon assisted removal is the safest way to do it. Our results prove that it's feasible and safe.
There are different potential advantages over branchial and cutdown. And we hope to collect more data to have more robust data to support this approach. Thank you.
- Thank you very much. So this is more or less a teaser. The outcome data will not be presented until next month. It's undergoing final analysis. So, the Vici Stent was the stent in the VIRTUS Trial. Self-expanding, Nitinol stent,
12, 14, and 16 in diameter, in three different lengths, and that's what was in the trial. It is a closed-cell stent, despite the fact that it's closed-cell, the flexibility is not as compromised. The deployment can be done from the distal end
or the proximal end for those who have any interest, if you're coming from the jugular or not in the direction of flow, or for whatever reason you want to deploy it from this end versus that end, those are possible in terms of the system. The trial design is not that different than the other three
now the differences, there are minor differences between the four trials that three completed, one soon to be complete, the definitions of the endpoints in terms of patency and major adverse events were very similar. The trial design as we talked about, the only thing
that is different in this study were the imaging requirements. Every patient got a venogram, an IVUS, and duplex at the insertion and it was required at the completion in one year also, the endpoint was venographic, and those who actually did get venograms,
they had the IVUS as well, so this is the only prospective study that will have that correlation of three different imagings before, after, and at follow-up. Classification, everybody's aware, PTS severity, everybody's aware, the endpoints, again as we talked about, are very similar to the others.
The primary patency in 12 months was define this freedom from occlusion by thrombosis or re-intervention. And the safety endpoints, again, very similar to everybody else. The baseline patient characteristics, this is the pivotal, as per design, there were 170 in the pivotal
and 30 in the feasibility study. The final outcome will be all mixed in, obviously. And this is the distribution of the patients. The important thing here is the severity of patients in this study. By design, all acute thrombotic patients, acute DVT patients
were excluded, so anybody who had history of DVT within three months were excluded in this patient. Therefore the patients were all either post-thrombotic, meaning true chronic rather than putting the acute patients in the post-thrombotic segment. And only 25% were Neville's.
That becomes important, so if you look at the four studies instead of an overview of the four, there were differences in those in terms on inclusion/exclusion criteria, although definitions were similar, and the main difference was the inclusion of the chronics, mostly chronics, in the VIRTUS study, the others allowed acute inclusion also.
Now in terms of definition of primary patency and comparison to the historical controls, there were minor differences in these trials in terms of what that historical control meant. However, the differences were only a few percentages. I just want to remind everyone to something we've always known
that the chronic post-thrombotics or chronic occlusions really do the worst, as opposed to Neville's and the acute thrombotics and this study, 25% were here, 75% were down here, these patients were not allowed. So when the results are known, and out, and analyzed it's important not to put them in terms of percentage
for the entire cohort, all trials need to report all of these three categories separately. So in conclusion venous anatomy and disease requires obviously dedicated stent. The VIRTUS feasibility included 30 with 170 patients in the pivotal cohort, the 12 months data will be available
in about a month, thank you.
- [Stephan Haulon] I'm going to present a case that was quite a challenging case. Those are my usual disclosures. And this patient I'm quoting is a patient that had dissecting thoracoabdominal aneurysm that was more than 18 centimeter long. You can see that there's major issues with the kinks
in the mid-descending thoracic aorta, two over 90 degree kinks, and you can also see that we're working in the narrow true lumen here, and what I want to show you here is that the SMA looks kind of occluded or with a mild perfusion, and you can see that above the celiac trunk,
it is nicely perfused, whereas you can see here that the true lumen is completely collapsed at the level of the visceral vessels. So there was a couple of issues associated with this case. This is a lateral mid-view showing you that the true lumen is completely collapsed here.
I'm not exactly sure what's happening with the SMA here. Sorry, and this is the IMA, lower, and you can see that there's a very large IMA that was patent and perfused by the true lumen. So we decided to treat this patient with a free thoracic endograft done proximal, then a TEVA,
and then the distal tubular graft that was landed just above the origin of this IMA. I designed the graft with a branch for the SMA not knowing exactly what I would look for, and the previous surgeon that referred the case to me
didn't manage to get a thoracic device up in this patient so there was a real concern that we would struggle during the case. The patient is contraindicated in the age, not far from his 80s, and had severe COPD, that's why he was not a candidate for an open approach.
So we used this four branch device, and what is specific about this device is that it has a TPDS delivery system, so what is that? This is something that I learned from Piotr Karpzak's research, it's a system where you have four pre-loaded wires that are already through the branches
so they're outside the graft, through the branch, inside the internal lumen, and you will see on the next video, this is the delivery system, and you can see that the pre-loaded wires are actually in a sheath above the delviery system. So you work over a through and through wire,
and this is Piotr's hand that you can see, you have a four meter through and through wire coming from the left axillary to the groin. Over this through and through wire, you advance a catheter from the top, and on the other side you will get the delivery system of the endograft,
you will see that very soon. You can see here is the sheath that is on top of the delivery system of the endograft, where you have the pre-loaded wires. So you're going to get the whole system up and get this proximal sheath from the axillary approach,
and then you have those wires that will direct you directly to the branches. So this is the case, you can see we have through and through access, and as I told you, the beginning of the case was trying to get access to the SMA to understand if the SMA was perfused by the true
lumen, or the false lumen. So here I'm looking from the false lumen, now I'm in the true lumen, trying from above, from below, and actually I never find access to the origin of the SMA, so I did this selective angio 3D image, and you
can see that the SMA is actually perfused from the IMA, so I was wrong to design a branch for the SMA, and I decided to occlude the branch. So to handle those huge kinks, I used the push and pull technique, you know, and you can see how I'm getting this graft up over all those kinks,
this is the first thoracic endograft. You will see on the next picture that once the graft is in position, I push on both ends of the wire so that it loops in the ascending. I position it just distal here to the left subclavian artery, and we're going to release this
first thoracic endograft, then get the second component up, and you can see it's still quite a challenge. And then we get it up, we need to have at least three or four stents overlap to release it, and remember this major kink that we had in the
mid-descending thoracic aorta. You will see that there's going to be sort of eructation. The patient, his blood pressure raised very significantly once I released the second graft so I had to use this scleroballoon right away to reopen the endograft lumen.
This is the third thoracic endograft that is positioned just above the celiac trunk, and now we're advancing the delivery system. You can see this is the sheath at the top of the delivery system where you have the pre-loaded wires, it goes inside the sheath, and I'm
getting the T-branch or the full branch endograft up here and we will position it like the other ones using this through and through technique, pushing from below and pulling from above. This is an angio to check that my fusion markers
are in a good position, and then we're going to open the endograft, making sure that the celiac trunk is above the celiac trunk marker, SMA above, and those are the two renal fenestrations above the origin of the two renal arteries. And then, using this pre-loaded wire, I push the catheter
directly through the fenestration from the top, getting access to the left renal artery. Once I have positioned a rosin wire into this left renal artery, I advance a Covera stent here, in this case I use Covera stents for the renals and BeGraft Plus for the visceral.
What you can see here is I'm actually releasing this Covera stent with quite a significant amount of the stent within the renal artery to have a very stable platform. At the top, you need to make sure that you have a full overlap with the branch.
I'm obviously not going to show you the four branches, I'm going to skip directly to the completion angiogram, and you can see the completion angiogram with the celiac trunk, both renals, and then the IMA feeding retrogradely the IMA, the SMA. So I was quite happy with this result.
Oops, now I need to go to the next slide please. There you are, thank you. So this was the post-op CT, and everything looked good at a first glance, but when looking more carefully on this CT scan, what I found is actually I had a very
large type 2 endoleak from this SMA that I never managed to access from the aortic lumen. And you can see the SMA is filled retrogradely and then is feeding the aneurysm sac, so now I have a big type 2 endoleak, which I think we'll never seal spontaneously because it's perfused by the SMA.
So I had to take this patient a couple of weeks later back to the OR under local anesthesia again using fusion guidance, and you can see here that I'm getting access to the IMA, injecting contrast to check that I'm in the right position, and then I'm
going to push a micro-catheter inside. You can see the microcatheter going up here, I'm going to inject again to check that I'm going the right direction. So this is the tip of the micro-catheter here, I have a lot of markers showing me the way to go,
the micro-catheter is now advancing, and I'm now almost where I need to be, and I'm going to check on the lateral view now. You can see, this is where is the tip of the micro-catheter, and I'm checking with the diffusion that I'm actually now at the origin of the SMA, this is an outline
of my fusion mask, and this is with the 3DVR. You see that I'm really where I need to be, and now I'm just advancing a couple of micro-coils at the origin of the SMA and just looking. This is the first branch of the SMA so I know that I'm not blocking anything special here.
A couple of coils, and then I'm going to check what's going on with my micro-catheter. And you can see that there's still flow going through those coils, so I added a couple of coils, smaller coils to get a nicely packed embolization. You can see a couple of coils that are advanced again.
And then this is the completion angio. You can see we're actually feeding the SMA, but not anymore the aneurysm sac. Can we move to the next one please? Thank you very much. So this is now the CT scan after this embolization.
You see the coils are just at the origin of the SMA. I don't have any more endoleak inside, those are artifacts from the coils, and we finally have completely excluded this complex thoracoabdominal aneurysm. So I think that the trick here was to use those
pre-loaded delivery, sorry, branches to the visceral and renal arteries, to use a through and through wire to get the device up, to use fusion imaging to know if we were in the true/false lumen, to know where the origin of the target vessel was, and as usual for
those complex dissection, you have to expect staged procedures to completely exclude the false lumen from aortic flow. Thank you very much for your attention. - [Speaker 1] Thanks Stephan, for a wonderful case. Any questions or comments, maybe just while you're
thinking about it? So I just missed a little bit in terms of the pre-loaded SMA wire, you can obviously use that to get through, and I presume you used an Amplatzer plug, or how did you embolize? - [Stephan Haulon] So, how did I block the SMA branch?
So usually the way I do it, I put a balloon expandable covered stent that is quite long, 47 or 57, and then I put an Amplatzer inside. - [Speaker 1] So that's a good tip, yeah. Obviously the trunk itself is too short to be confident with that.
- [Stephan Haulon] Yeah, at the beginning of the experience, I was just putting an Amplatzer in the trunk, and we had a couple of failures, and now I feel more secure positioning a nice landing zone. I mean, having a longer branch with this being expandable. - [Speaker 1] So that's a very good tip, thanks for that.
- [Speaker 2] I have a question, I mean, we know how important is the SMA, especially in these patients, but if you have to do another case like this one, do you think this could be more useful to do a first stage total to reopen the SMA to the celiac or to the IMA?
- [Stephen Haulon] The problem here was that the true lumen was completely collapsed, and I didn't know if it was just a dynamic malperfusion, or if there was some kind of stenosis. I still don't understand exactly. The idea when I started the case was that if I could
actually access the SMA, was to do exactly what you're saying, I was going to probably stent it to reopen it at the beginning. But I never managed to access the SMA from the true, the false lumen, from above, from below. Probably this was
because, maybe because the IMA was perfusing with a very nice flow this SMA. So I think there was some kind of retraction of the origin of the SMA. - [Speaker 2] Okay. - [Speaker 1] Stephan that thoracic component that's
got a tortuosity of 270 degrees, or worse, you know, in your experience you did a great job delivering the graft, but how's that going to perform, do you think, in terms of, you know, when we see remodeling, and do you think there's a risk of significant kinking and stenosis of the lumen?
- [Stephan Haulon] So I mean, the second graft when it went through that specific curve, occluded the true lumen right away. The blood pressure went up like an acute coarctation, and I think that with my coated balloon I actually burst the dissection flap, and that's why it's now
open, and I checked on the CPR that I have a nice lumen. But it's a concern, I think very importantly when you have such angulation, you need to be very aggressive with the overlap between the various components because you don't know what's going to happen, and you see we have I think almost four or five stents overlap between the
various components. - [Speaker 1] Okay, well thank you very much.
- Thank you Mr. Chairman. Ladies and gentleman, first of all, I would like to thank Dr. Veith for the honor of the podium. Fenestrated and branched stent graft are becoming a widespread use in the treatment of thoracoabdominal
and pararenal aortic aneurysms. Nevertheless, the risk of reinterventions during the follow-up of these procedures is not negligible. The Mayo Clinic group has recently proposed this classification for endoleaks
after FEVAR and BEVAR, that takes into account all the potential sources of aneurysm sac reperfusion after stent graft implant. If we look at the published data, the reported reintervention rate ranges between three and 25% of cases.
So this is still an open issue. We started our experience with fenestrated and branched stent grafts in January 2016, with 29 patients treated so far, for thoracoabdominal and pararenal/juxtarenal aortic aneurysms. We report an elective mortality rate of 7.7%.
That is significantly higher in urgent settings. We had two cases of transient paraparesis and both of them recovered, and two cases of complete paraplegia after urgent procedures, and both of them died. This is the surveillance protocol we applied
to the 25 patients that survived the first operation. As you can see here, we used to do a CT scan prior to discharge, and then again at three and 12 months after the intervention, and yearly thereafter, and according to our experience
there is no room for ultrasound examination in the follow-up of these procedures. We report five reinterventions according for 20% of cases. All of them were due to endoleaks and were fixed with bridging stent relining,
or embolization in case of type II, with no complications, no mortality. I'm going to show you a couple of cases from our series. A 66 years old man, a very complex surgical history. In 2005 he underwent open repair of descending thoracic aneurysm.
In 2009, a surgical debranching of visceral vessels followed by TEVAR for a type III thoracoabdominal aortic aneurysms. In 2016, the implant of a tube fenestrated stent-graft to fix a distal type I endoleak. And two years later the patient was readmitted
for a type II endoleak with aneurysm growth of more than one centimeter. This is the preoperative CT scan, and you see now the type II endoleak that comes from a left gastric artery that independently arises from the aneurysm sac.
This is the endoleak route that starts from a branch of the hepatic artery with retrograde flow into the left gastric artery, and then into the aneurysm sac. We approached this case from below through the fenestration for the SMA and the celiac trunk,
and here on the left side you see the superselective catheterization of the branch of the hepatic artery, and on the right side the microcatheter that has reached the nidus of the endoleak. We then embolized with onyx the endoleak
and the feeding vessel, and this is the nice final result in two different angiographic projections. Another case, a 76 years old man. In 2008, open repair for a AAA and right common iliac aneurysm.
Eight years later, the implant of a T-branch stent graft for a recurrent type IV thoracoabdominal aneurysm. And one year later, the patient was admitted again for a type IIIc endoleak, plus aneurysm of the left common iliac artery. This is the CT scan of this patient.
You will see here the endoleak at the level of the left renal branch here, and the aneurysm of the left common iliac just below the stent graft. We first treated the iliac aneurysm implanting an iliac branched device on the left side,
so preserving the left hypogastric artery. And in the same operation, from a bowl, we catheterized the left renal branch and fixed the endoleak that you see on the left side, with a total stent relining, with a nice final result on the right side.
And this is the CT scan follow-up one year after the reintervention. No endoleak at the level of the left renal branch, and nice exclusion of the left common iliac aneurysm. In conclusion, ladies and gentlemen, the risk of type I endoleak after FEVAR and BEVAR
is very low when the repair is planning with an adequate proximal sealing zone as we heard before from Professor Verhoeven. Much of reinterventions are due to type II and III endoleaks that can be treated by embolization or stent reinforcement. Last, but not least, the strict follow-up program
with CT scan is of paramount importance after these procedures. I thank you very much for your attention.
- Thank you Dr. Veith and Dr. Helan for the honor of the podium and for being included in this very prestigious panel. I appreciate it greatly. These are my disclosures. So there's a number of established strategies with fenestrated EVAR to overcome some of the challenges
that we face during these procedures. For downward oriented target arteries we employ brachial access, we deflect wires and catheters off of the top cap or a balloon that can be inflated. Fixed angle sheaths,
getting access into the target vessels can be accomplished by swallowing the balloon or replace a balloon into the target vessel first, inflate it and then deflate it while we're pushing forward on the sheath. And also the large bore femoral access
on the contralateral side allows us to have multiple access sites, multiple sheaths, but this oftentimes requires 20, 22 French sheaths to accomplish this. Well this standard FEVAR technique is what I adopted when I first went out into practice
and as often is the case, necessity becomes the mother of invention. And when we lost access to the beacon tip Van Schie catheters, we had to come up with alternative techniques for gaining access to these vessels
and for accomplishing these procedures. And what this strategy has eventually evolved in to is what I've coined as next generation FEVAR, and I take a slightly different approach from the well-established techniques. And these are the ancillaries that you need
to perform these procedures. The main thing is the conformable sheaths which has completely changed my approach to doing these procedures. And I'll show you a single case that illustrates many of the strengths of these conformable sheaths
and the strengths of this technique. But the conformable sheaths that are available in the United States are twofold. The Oscor Destino Twist, which is available in 6.5, seven French, and 8.5 French. There's also a 12 French sheath available as well
with variable deflection curves. The Aptus TourGuide is actually manufactured by Oscor and sold through an OEM to now Medtronic, but it is exactly the same type of the conformable sheath available in the same sizes and deflectable curves.
As far as our contralateral sheath, what I've found with this technique is that we've been able to significantly downsize the contralateral sheath to allow access by only using Rosen wires and leaving Rosen wires only behind in most of
the selected and wired vessels. This is a 16 French and now what I employ is a 14 French dry seal in almost all of our cases. So this is a patient with a juxtarenal aneurysm that had an accessory lower pole or duplicated left renal and a rather large IMA
that we incorporated through a PMAG design in the, in his repair. And this video shows the conformable sheath acting as not only the sheath but the selection catheter as it goes in to the fenestration and out into the target artery.
As we move to the next step, the glide wire then is passed into the vessel followed by a quick cross catheter, and then we exchange the glide wire for a Rosen, and then leave the Rosen behind and move on to the next vessel.
This is selection of the celiac and then selection of the right renal. And then the left renal. And actually we were able to get the second renal as well with this setup. This is one of the,
so this is delivering the stent to the celiac as we move back up and we kind of just reverse the order as we go back to one of the first vessels that we selected. And we would never attempt this maneuver with a fixed angled sheath. But the strength of the conformable sheath
allows it to maintain its shape and actually throw the stent across the fenestration and into the vessel rather than having the sheath into the target vessel and unsheathing it. We then can use the conformable sheath to select downward deflected branches as the IMAs illustrates.
And on the one month post-CTA all vessels are stented, widely patent, aneurysm sac has actually begun to shrink, and this is our 3D rendering of that one month CTA. So with my move I started keeping track of the amount of time it takes to catheterize these vessels. Real time from the start of catheterization to the end
of the final vessel being catheterized. And we did this in 57 consecutive cases with a total of 215 total fenestrations. I used brachial access not at all during any of these cases and we recorded this time. And what we found in those 57 cases
is that we had a mean of 30 minutes from the time we put the conformable sheath in to the time we were done selecting all of the vessels, that all the target vessels and had Rosen wires in those vessels. When we subtracted out the few outliers that we had
with high grade stenoses or extreme angulated origins, we ended up with a mean and a median that came together at about 21 minutes. The cost comparison has been raised as an issue, but when you actually only use one sheath it's actually cheaper to use the conformable approach
and it doesn't take into account the billed hybrid OR time which can be upwards of $200 per minute. The cost of brachial access and decreased target cannulation wire time. So in summary FEVAR with this approach and with conformable sheaths
facilitates selection of fenestrations, downward deflected branches and target arteries. It avoids the complications of brachial access and large bore contralateral sheaths. It provides additional stability to allow delivery of appropriately sized covered stents
and it simplifies the technique and decreases the costs. Thank you.
- Thank you, Doctor Chuter. So, as you saw in Eric's presentation, really indwelling catheters and wires have become more or less routine for us. And they're nothing new to this era of complex and vascular repair. We've seen them a long time and
we started using them, of course, for iliac branch devices, as you can see here. And the concept is the same when you use them for other branches or fenestrations, as I'll show you. And here, an iliac branch is coming over with that indwelling catheter and snaring
from the contralateral end to be able to get that sheath. This is a helical-helical device, so putting that sheath over to get access to the contralateral side. So why and when do we need preloaded grafts with wires or catheters for complex aortic repair? Well, sometimes we have access issues
and it alleviates that, as I'll show you. Having the fenestrations or branches pre-catheterized will intuitively reduce X-ray exposure times and operating times, and also help catheterization in difficult anatomy, as Eric alluded to, and thereby
keeping the procedure down and avoiding large sheaths in both groins, at the same time minimizing lower-extremity ischemia time. This is an example of putting a fenestrated device in a previous infrarenal device. And the multitude of markers here
makes it very difficult to actually locate the fenestrations on the new graft, so it's very advantageous in these settings to have the fenestrations preloaded. This was first described by Krassi Ivancev back in 2010, and this is the original
preloaded design for a juxtarenal fenestrated device. And you can see a loop wire going through the top of that device. And a very simple handle with a couple of wires and things coming out of it, and some technical difficulties with wire catches
and other things made us move away from that design. It was later evolved into this bi-port delivery system, which allows you to have access to two fenestrations from a unilateral approach with indwelling renal wires and then sheaths, and having
those wires go through the renal fenestrations. And this evolved into the p-branch off-the-shelf fenestrated device from Cook, as you can see here. And you can see that loop wire coming out through that right renal fenestration
going through the top of the graft. And this is the catheter just describing how you then can use a double-puncture technique to access that renal artery and place the sheath there. The advantages of the technique
was described by Doctor Torsello's group in Munster here, showing that it does in fact reduce the amount of radiation in contrast during these procedures as well as bringing the procedure time down. And this was described by Mark Farber as well
in the experience of the off-the-shelf p-branch devices. We modified the preloaded device a little bit further by taking away that very top stent, and instead of having the loop wire is on the p-branch, just placing catheters through those fenestrations,
but still using the triport handle, and then replacing those with 018 wires to achieve stable positions. Of course, preloaded catheters and wires can then be used for branch procedures as well, as Eric Verhoeven just showed you. And in this case, just using these
indwelling catheters to allowing wires to be snared from above and then advanced into the specific branches and distal arteries. And of course, if you use a fenestrated device for thoraco-abdominal repair, the same applies. And this is from Carlos Timaran's paper
just showing how he places these wires from above in these discrete fenestrations. This is a combined device of a two-branch, two-fen device, if you would like, that has indwelling wires going through the fenestrations and out
through the branches, which we use on occasion. You can then bring that out through the axillary artery, and you get access directly from above to the branches from below for the fenestrations. And we found it very useful in the setting of narrow aortic
lumens and chronic aortic dissections, as in this case. And you can see here, then, on the wires placing the sheath, catheterizing the renals, and then at the same time, having these access catheters in the branches so you don't have to access those for a nice end result.
So in summary, Chairman, ladies and gentlemen, preloaded wire I think reduces the operative time and the X-ray exposure during these procedures. It's very useful, particularly in complex torturous aortas, during redo EVAR cases with preexisting devices, and
compromised iliac access, and in the situations of narrow aortas, like in chronic aortic dissections. Thank you very much.
- Thank you very much for inviting me here again and I'll be talking about thermal ablation RCTs. My coauthor, Michel Perrin from Lyon, in France, the gourmet capital in the world has collected RCTs on operative treatment of CVD since 1990. Today he has 186 collected RCTs
of the which 84 involve thermal ablation. You can find all this data for free in Phlebolymphology.org. Do we need further RCTs? Well systematic reviews and meta-analyses increasingly important in evidence-based medicine. And this development is well-described
by Gurevitch in Nature this year and criticized by Ioannidis two years earlier. Common sense is a good principle when you try to understand meta-analyses. Do most studies point in the same direction?
Is the effect significant? Are the patient-related outcome measures relevant and what happens if you exclude one study? Since 2008, 10 years back, these are the available meta-analyses and the last came from Ireland earlier this year.
It was published in the JVS, endovenous and in fact this is in March. And they found nine RCTs comparing conventional surgery and endovenous therapy with five years or more follow-up that were selected. Primary outcome was recurrence rate.
There is some sole recurrence rate was that there is no significant difference in laser versus surgery, same for radioactive frequency versus surgery and radioactive frequency versus laser. They found an inferiority
of ultrasound guided foam sclerotherapy versus laser and surgery. Their conclusions were that the quality of evidence is poor therefore more trials that are well-powered to examine long-term outcomes are warranted. The new kids on the block,
steam, MOCA, and Venaseal, are not included in the meta-analyses due to lack of more than five years follow-up in their paper. Obsolete RCTs. Endovenous laser in the presented long-term RCTs
were performed by 810-980 nanometer wavelength using a bare fiber. There is a paucity of RCTs comparing open surgery with novel endovenous laser and new RF techniques. Recent criticism against endovenous ablation, is the pendulum swinging towards high ligation
and stripping again? Olle Nelzen from Sweden in an editorial in British Journal of Surgery reconsidering the endovenous revolution, wrote that neovascularization is a dominant finding following high ligation and stripping
but proximal venous stumps and incompetent anterior accessory saphenous veins are the main factor after endovenous ablation. So long-term follow-up suggests that the recurrence rate after endovenous ablation seem to increase over time. A substantial number of patients who have undergone
endovenous ablation will eventually develop symptomatic recurrence requiring repeat therapy. And such scenario would change the equation regarding patient benefit and costs making endovenous ablation less competitive and challenging current guidelines.
So summary of needs for further RCTs. Quality of present RCTs poor in several meta-analyses, no thermal endovenous technique is superior to open surgery, RCTs rapidly obsolete due to change in technology, and more trials that are well-powered to examine long-term outcomes are warranted.
So final point, apparently we need more RCTs to satisfy the quality requirements for clinically important systematic reviews and meta-analyses. And what about the clinical guidelines? Thank you very much.
- I'm going to take it slightly beyond the standard role for the VBX and use it as we use it now for our fenestrated and branch and chimney grafts. These are my disclosures. You've seen these slides already, but the flexibility of VBX really does give us a significant ability to conform it
to the anatomies that we're dealing with. It's a very trackable stent. It doesn't, you don't have to worry about it coming off the balloon. Flexible as individual stents and in case in a PTFE so you can see it really articulates
between each of these rings of PTFE, or rings of stent and not connected together. I found I can use the smaller grafts, the six millimeter, for parallel grafts then flare them distally into my landing zone to customize it but keep the gutter relatively small
and decrease the instance of gutter leaks. So let's start with a presentation. I know we just had lunch so try and shake it up a little bit here. 72-year-old male that came in, history of a previous end-to-side aortobifemoral bypass graft
and then came in, had bilateral occluded external iliac arteries. I assume that's for the end-to-side anastomosis. I had a history of COPD, coronary artery disease, and peripheral arterial disease, and presented with a pseudoaneurysm
in the proximal juxtarenal graft anastomosis. Here you can see coming down the thing of most concern is both iliacs are occluded, slight kink in the aortofemoral bypass graft, but you see a common iliac coming down to the hypogastric, and that's really the only blood flow to the pelvis.
The aneurysm itself actually extended close to the renal, so we felt we needed to do a fenestrated graft. We came in with a fenestrated graft. Here's the renal vessels here, SMA. And then we actually came in from above in the brachial access and catheterized
the common iliac artery going down through the stenosis into the hypogastric artery. With that we then put a VBX stent graft in there which nicely deployed that, and you can see how we can customize the stent starting with a smaller stent here
and then flaring it more proximal as we move up through the vessel. With that we then came in and did our fenestrated graft. You can see fenestrations. We do use VBX for a good number of our fenestrated grafts and here you can see the tailoring.
You can see where a smaller artery, able to flare it at the level of the fenestration flare more for a good seal. Within the fenestration itself excellent flow to the left. We repeated the procedure on the right. Again, more customizable at the fenestration and going out to the smaller vessel.
And then we came down and actually extended down in a parallel graft down into that VBX to give us that parallel graft perfusion of the pelvis, and thereby we sealed the pseudoaneurysm and maintain tail perfusion of the pelvis and then through the aortofemoral limbs
to both of the common femoral arteries, and that resolved the pseudoaneurysm and maintained perfusion for us. We did a retrospective review of our data from August of 2014 through March of 2018. We had 183 patients who underwent endovascular repair
for a complex aneurysm, 106 which had branch grafts to the renals and the visceral vessels for 238 grafts. When we look at the breakdown here, of those 106, 38 patients' stents involved the use of VBX. This was only limited by the late release of the VBX graft.
And so we had 68 patients who were treated with non-VBX grafts. Their other demographics were very similar. We then look at the use, we were able to use some of the smaller VBXs, as I mentioned, because we can tailor it more distally
so you don't have to put a seven or eight millimeter parallel graft in, and with that we found that we had excellent results with that. Lower use of actual number of grafts, so we had, for VBX side we only had one graft
per vessel treated. If you look at the other grafts, they're anywhere between 1.2 and two grafts per vessel treated. We had similar mortality and followup was good with excellent graft patency for the VBX grafts.
As mentioned, technical success of 99%, mimicking the data that Dr. Metzger put forward to us. So in conclusion, I think VBX is a safe and a very versatile graft we can use for treating these complex aneurysms for perfusion of iliac vessels as well as visceral vessels
as we illustrated. And we use it for aortoiliac occlusive disease, branch and fenestrated grafts and parallel grafts. It's patency is equal to if not better than the similar grafts and has a greater flexibility for modeling and conforming to the existing anatomy.
Thank you very much for your attention.
- I'd like to share with you our experience using tools to improve outcomes. These are my disclosures. So first of all we need to define the anatomy well using CTA and MRA and with using multiple reformats and 3D reconstructions. So then we can use 3D fusion with a DSA or with a flouro
or in this case as I showed in my presentation before you can use a DSA fused with a CT phase, they were required before. And also you can use the Integrated Registration like this, when you can use very helpful for the RF wire
because you can see where the RF wire starts and the snare ends. We can also use this for the arterial system. I can see a high grade stenosis in the Common iliac and you can use the 3D to define for your 3D roadmapping you can use on the table,
or you can use two methods to define the artery. Usually you can use the yellow outline to define the anatomy or the green to define the center. And then it's a simple case, 50 minutes, 50 minutes of ccs of contrast,
very simple, straightforward. Another everybody knows about the you know we can use a small amount of contrast to define the whole anatomy of one leg. However one thing that is relatively new is to use a 3D
in order to map, to show you the way out so you can do in this case here multiple segmental synosis, the drug-eluting-balloon angioplasty using the 3D roadmap as a reference. Also about this case using radial fre--
radial access to peripheral. Using a fusion of image you can see the outline of the artery. You can see where the high grade stenosis is with a minimum amount of contrast. You only use contrast when you are about
to do your angiogram or your angioplasty and after. And that but all everything else you use only the guide wires and cathers are advanced only used in image guidance without any contrast at all. We also been doing as I showed before the simultaneous injection.
So here I have two catheters, one coming from above, one coming from below to define this intravenous occlusion. Very helpful during through the and after the 3D it can be helpful. Like in this case when you can see this orange line is where
the RF wire is going to be advanced. As you can see the breathing, during the breathing cycle the pleura is on the way of the RF wire track. Pretty dangerous stuff. So this case what we did we asked the anesthesiologist
to have the patient in respiratory breath holding inspiration. We're able to hyperextend the lungs, cross with the RF wire without any complication. So very useful. And also you can use this outline yellow lines here
to define anatomy can help you to define where you need to put the stents. Make sure you're covering everything and having better outcomes at the end of the case without overexposure of radiation. And also at the end you can use the same volt of metric
reconstruction to check where you are, to placement of the stent and if you'd covered all the lesion that you had. The Cone beam CT can be used for also for the 3D model fusion. As you can see that you can use in it with fluoro as I
mentioned before you can do the three views in order to make sure that the vessels are aligned. And those are they follow when you rotate the table. And then you can have a pretty good outcome at the end of the day at of the case. In that case that potentially could be very catastrophic
close to the Supra aortic vessels. What about this case of a very dramatic, symptomatic varicose veins. We didn't know and didn't even know where to start in this case. We're trying to find our way through here trying to
understand what we needed to do. I thought we need to recanalize this with this. Did a 3D recan-- a spin and we saw ours totally off. This is the RFY totally interior and the snare as a target was posterior in the ASGUS.
Totally different, different plans. Eventually we found where we needed to be. We fused with the CAT scan, CT phase before, found the right spot and then were able to use
Integrated registration for the careful recanalization above the strip-- interiorly from the Supraaortic vessels. As you can see that's the beginning, that's the end. And also these was important to show us where we working.
We working a very small space between the sternal and the Supraaortic vessels using the RF wire. And this the only technology would allowed us to do this type of thing. Basically we created a percutaneous in the vascular stent bypass graft.
You can you see you use a curved RF wire to be able to go back to the snare. And that once we snare out is just conventional angioplasty recanalized with covered stents and pretty good outcome. On a year and a half follow-up remarkable improvement in this patient's symptoms.
Another patient with a large graft in the large swelling thigh, maybe graft on the right thigh with associated occlusion of the iliac veins and inclusion of the IVC and occlusion of the filter. So we did here is that we fused the maps of the arterial
phase and the venous phase and then we reconstruct in a 3D model. And doing that we're able to really understand the beginning of the problem and the end of the problem above the filter and the correlation with the arteries. So as you can see,
the these was very tortuous segments. We need to cross with the RF wire close to the iliac veins and then to the External iliac artery close to the Common iliac artery. But eventually we were able to help find a track. Very successfully,
very safe and then it's just convention technique. We reconstructed with covered stents. This is predisposed, pretty good outcome. As you can see this is the CT before, that's the CT after the swelling's totally gone
and the stents are widely open. So in conclusion these techniques can help a reduction of radiation exposure, volume of contrast media, lower complication, lower procedure time.
In other words can offer higher value in patient care. Thank you.
- Okay, so I first continue. So after this data, which really, in our experience, really changed our treatment, we really don't want to treat, actually thoracoabdominals without coiling anymore. Now how to do it and, in fact, we also went through quite a learning curve. In the beginning, of course, was not easy for us
to reach segment arteries and big aneurysms all the tine. We learned form coiling in infrarenal aneurysms, I think, quite a lot and extended then to a higher segment of the aorta. So all together, it was not a short learning curve. So first of all, again, how do we do it?
We do it in local anesthesia, percutaneous, actually, always trans-femoral, although, sometimes the segmented arteries have a steep, at least in the beginning, a steep course downwards. We actually never come from brachial. We don't do a spinal drainage during coiling
and we monitor the patients 48 hours after that. We keep them in the hospital to see whether they develop any neurological complications, which they have, so far, never done. We don't do it on an intensive care and we also do not do spinal drainage then
during the stent graft implantation, which eventually, later then is done in general anesthesia. So this is the basic of the treatment, this is a little bit adopted from neuro radiology. Though, we are just taking bigger devices, so standard is so to say takes some six French
guiding catheter, usually I take an ema curve like this here. And into that very nicely fits a catheter, which is usually a source catheter, not this one, the source catheter is straight here. And through that source catheter, which is five French
catheter, we take a micro catheter through and that is here, this so called tower of power, which has been described, as I said, for neuro radiology procedures. So this is, however, sometimes the problem, you can of course choose several different curves here,
some are smaller, some are bigger. Bigger may not be so easy to handle and direct to your origin of the segmental artery, but in big aneurysms, of course, that can be a problem here to reach the arteries. So what we do with sticking a diagnostic catheter
into the guiding catheter is, that if you pull back here, now, your five French diagnostic catheter, you can really make out of this, move the twistable, toggleable catheter and that enables you in many cases to eventually then, really, in a stable way reach the ostium.
In those cases, where this is not possible, we use this steering deflecting steerable guiding catheters or sheaths, which is, of course, expensive and is really only necessary in very few selective cases, but this is clearly also helpful here. Side wind to one is loaded and then you can reach,
also, in very big arteries, aortas, the segmental ostium quite conveniently. So, of course, we don't do it in all cases, not in urgent repair, because after coiling or after every session of coiling, we want to have some time to let the spinal network develop.
So we can't do it in urgent cases. Renal insufficiency is a problem, although, with CT reading sometimes it's not so difficult to find the segmental artery origins, also, with very little contrast. Severe iliac kinking, aortic elongation
can be a problem indeed, we have some tricks for this and adipositas permagna, well, can be difficult, of course, difficult to see sometimes these arteries and that also requires then quite high radiation doses. This is what we do in very kinked iliac arteries and this is extremely helpful to have this some kind
of reinforced or extended power of tower. So in the beginning, we took a 12 French sheath in, we let the stiff wite in and we punctured, once again, up here of the sheath and brought parallel up then our usually power of tower and with this, you have a very, very stable condition
to reach the segmental arteries. Reason, that we changed to 12 French to nine French sheath, I don't think this is a problem in our days, having closure devices available for these kind of cases. So what shall we take for coiling, usually, we take this, let's call it regular coils
with these feathers, like, things here on top to induce thrombosis. Sometimes, in bigger segmental arteries, you can also do use a vascular plugs. This requires relatively stable access to the arteries. Clearly, no fluids, which are risky
and can embolize distally, we fear and may induce here even a spinal ischemia. So we have never used any fluids in these kind of cases. We are also still in the learning curve, for example, sometimes the arteries after coiling to open up again. Here is a case several weeks after coiling,
you can see here, that the blood here just passes these coils here, this is another case, where you can see, that actually the blood flow seems to be not diminished due to this coiling. So segmental arteries, we learned, are really completely different to others, you never see atherosclerosis here,
sometimes in the origin, probably some plug from the aorta, but they can develop very quickly to bigger arteries and that's why we probably see sometimes here a flow going down. So again, also, we have still a lot of things to work. Is it necessary to occlude them completely?
Is maybe reduction of flow sufficient? Sometimes maybe spinal ischemia is also due to embolization through segmental arteries and then this should actually be sufficient to avoid any embolization into the spinal cord. So after embolization, well, during embolization, also,
we also have to ask ourselves how densely do we have to pack these, cuz you can see, that there is several open areas between the coils. That should be actually usually enough to induce thrombosis. This is, we think, clearly, not enough and this is from the first publication,
not from our institute, I think this is definitely not enough, so indeed, you have to have some stable position of your catheter to pack these coils in and try to occlude the arteries as good as you can. So again, some questions to the coils, which should be used, the standard coils, maybe, which still have always
some holes in between. There are others, for example, the volume coils, which are used in neuro radiology. Which with one coil you can complete occlude the artery. Or there are some micro plugs, which actually go through micro catheters, those here are really
more sufficient and effective in closing the artery, but clearly they are also much more expensive, than regular coils. Where to coil, I think, it's very important not to coil too far distal, because then you're counter productive, you maybe avoid production or development
of this spinal network, you should really try to coil here at that proximal part here to let those networks here distally develop. This is, I think, very important and nevertheless, it can also occur, that you're actually coiling here at that proximal part or some collaterals develop
also proximal to these coils. So the more ostium your coil, I think, are better here. You can see, that we coiled here, but some coils collaterals developed here, feeding, now, here another segmental artery, which is secluded and the proximal part, but at the end we were not completely successful here
in occluding this segmental artery. So shall we also close every artery, shall we only close small arteries, sometimes we see, especially, in big aneurysms, that your ostium here is twisted and become stenotic, will become very difficult to get in. Same artery six weeks later, you can see here,
that it has developed already some collaterals, so do we need to coil this also? These are also still open questions. And then some thoughts about where to start. In the past, it was thought, that it was one big Adamkiewicz artery, great marginal artery,
but that is currently obsolete. We know, that there are several here. So shall we look for the biggest anterior radiculomedullary artery and shall we start with coiling here or shall we start somewhere else? Usually this ARMA, this big ARMA comes off
between TH 11, L one, L two, usually on the left side, here on the right side, so we found here, with our first shot here, this big ARMA going here into this spinal artery. So should we not close this now or should we exactly close this first, these are still open questions. First we go to this here, to have this closed
and let others develop here, some collaterals here. Here is another case, where a stent graft was already in this, not a covered stent, but an open cell stent and here we saw, that here are already some collaterals opened up. You can see here due to an injection to the right side,
this collateral worked upwards and then to the left side, finally here feeding the anterior spinal artery. So also in these cases, it demonstrates to you, that you should coil here, maybe, first, before you go to the other arteries. This is another example here, where to start,
how many and the first session, usually, we do four arteries. In the beginning, this is just our protocol, where we start now. We start usually in that area, we think the main radiculomedullary artery has its offspring
and from that we go more distal and into the proximal counterpart. So to summarize segmental artery coiling and these thoracoabdominal aneurysms can be challenging, it's a new field with may open questions. About our first experience with this is, for us,
really very promising and it's also safe. Thank you very much. (applauding) - [Man] Thank you for this great presentation. I have few questions to you, how long do you need for such an intervention?
And how can you be sure before you start with implantation, I suppose, that you will do this not in one session, but you will do this with a timeframe. That was a long year waiting and before you start to implant the prothesis, it is the question for you too, how you control, that all artery occlude?
- [Presenter] Yeah, many questions, so first of all, how long does it take to coil. So of course, in the beginning it took us some time. It always-- - [Man] Some hours. - [Presenter] Not some hours,
but you have published this also in your publication. - So the data, that we started with like two hours, maybe, it was two hours, but now we got under one hour. - [Presenter] Under one hour per session, let's say for segmental arteries.
It always depends, also, on the anatomy. In the beginning, we were waiting quite a lot between these coilings, because of course, that was all new for us, so we took the time, usually, these are cases, where you ordered a CMD, so you had a timeframe of two months or longer
to wait for the graft anyway. So this time we took for segmental artery coiling, we took several weeks in between segmental artery coiling, bu knowing from the animal models, that during one week, that spinal network should develop, actually, now, down to one week in between coiling sessions.
- [Man] Okay and how you control before you implant? - [Presenter] We don't. - [Man] You don't, you're hoping only? - [Presenter] Well, we have seen some segmental arteries open again, so we did, clearly, did not investigate this systematically, how many did open.
Again, because there are many questions. Maybe it's really enough to just have some coils and to prevent any embolization during the stent graft implantation towards spinal ischemia. We don't know all this, it seems to be a little bit problematic to really check it, we could check it by CT,
you could check it by angiography, but since you're using a lot of contrast during the stent graft implantation anyway there was a step, which we actually did not, now, do systematically. - [Man] And how many coils do you need to close all these arteries?
- [Presenter] For one segmental artery, you need something like four, five, six coils. So this, usually, coils, they recently got very cheap. - [Man] A very cheap intervention. - [Presenter] It is, it is, in fact, not too expensive. If you would use these volume coils, plugs,
that would be a completely other story on micro plugs, but these very standard coils is not expensive, indeed. - [Man] The last question, it is in regard of the application of this technique. Did you have any spinal lesions after stent implantation? - [Woman] So in this series, we have not had any issues
and we are currently looking at the matter, the non invasive imaging to exactly establish when is the point, the best point to implant the stent graft do we really need to wait as long or if we can implant it sooner. So we have some clues, that the preconditioning,
it's developing in one week and we are ready to go for the stent graft. It's very important, that you perioperatively, you adopt the classical perioperative on your strategies. That means we stop the blood pressure, lowering medication so we have a minatorial pressure of 85 to 90 millimeter
of mercury, we have a good oxygen saturation, that means you have a hemoglobin level around 10 gram per deciliter. And also on the ISU, the patient have the same tract. And we basically, we looked, that during the first month, the blood pressure of the patient, it's not too low.
- [Man] Do you have the impression this relationship between the type of aneurysm or the length of aneurysm, they're anatomical and the need of such an intervention? - [Woman] Well, basically, you've seen the data, the published data shows, that the inner thoracoabdominal krau-for type two after, endovascular period
you have up to 19% spinal cord ex-pand-ment of open repair, it's 22%. My opinions is, that the mechanism of spinal cord ischemia after about this procedure, it's different, but basically you need to treat both type of patient for the endovascular pair with both.
We think, that we should treat type two for sure and type three also and maybe type four, and we think type four too, because the proximal landing zone in those type of repair, it's not, it's not the same. So type four, basically, you treat it endo, you get your landing zone, as for treating type three,
and type three, it's getting in type two. - [Man] And did you observe any neurological side effect during the embolization? - [Woman] Recently, we had a patient, where we inject contrast and she had some numbness in her legs, but after two minutes or less than one minute,
she had nothing and we continue with the procedure and she recovered. But her blood pressure were, as I remember, it was not high, it was at systolic of 120 millimeter, that's why we stopped that coiling for that patient. And we had her blood pressure medication stopped
and recoiled them, her, after, I think, seven days. And we had no clinical evidence of spinal cord ischemia. - [Man] Thank you again for all this information, so that we implanted stents for years without this technique.
- [Presenter] Sorry? - [Man] Was that a criminal act? - [Presenter] No, I can only, from our experience, we did have quite some spinal cord ischemias after extensive stent grafting in long thoracoabdominal aneurysms.
It's always very terrible experience to have this. Since we do coiling, we didn't have any problem anymore. It's not a lot of patients, which I think, all together, we have maybe 80 now, but due to this experience, I don't want to do stent grafting without coiling anymore. - [Man] Okay, this is a very important message,
because this is a real religious message.
- Thank you. I have two talks because Dr. Gaverde, I understand, is not well, so we- - [Man] Thank you very much. - We just merged the two talks. All right, it's a little joke. For today's talk we used fusion technology
to merge two talks on fusion technology. Hopefully the rest of the talk will be a little better than that. (laughs) I think we all know from doing endovascular aortic interventions
that you can be fooled by the 2D image and here's a real life view of how that can be an issue. I don't think I need to convince anyone in this room that 3D fusion imaging is essential for complex aortic work. Studies have clearly shown it decreases radiation,
it decreases fluoro time, and decreases contrast use, and I'll just point out that these data are derived from the standard mechanical based systems. And I'll be talking about a cloud-based system that's an alternative that has some advantages. So these traditional mechanical based 3D fusion images,
as I mentioned, do have some limitations. First of all, most of them require manual registration which can be cumbersome and time consuming. Think one big issue is the hardware based tracking system that they use. So they track the table rather than the patient
and certainly, as the table moves, and you move against the table, the patient is going to move relative to the table, and those images become unreliable. And then finally, the holy grail of all 3D fusion imaging is the distortion of pre-operative anatomy
by the wires and hardware that are introduced during the course of your procedure. And one thing I'd like to discuss is the possibility that deep machine learning might lead to a solution to these issues. How does 3D fusion, image-based 3D fusion work?
Well, you start, of course with your pre-operative CT dataset and then you create digitally reconstructed radiographs, which are derived from the pre-op CTA and these are images that resemble the fluoro image. And then tracking is done based on the identification
of two or more vertebral bodies and an automated algorithm matches the most appropriate DRR to the live fluoro image. Sounds like a lot of gobbledygook but let me explain how that works. So here is the AI machine learning,
matching what it recognizes as the vertebral bodies from the pre-operative CT scan to the fluoro image. And again, you get the CT plus the fluoro and then you can see the overlay with the green. And here's another version of that or view of that.
You can see the AI machine learning, identifying the vertebral bodies and then on your right you can see the fusion image. So just, once again, the AI recognizes the bony anatomy and it's going to register the CT with the fluoro image. It tracks the patient, not the table.
And the other thing that's really important is that it recognizes the postural change that the patient undergoes between the posture during the CT scan, versus the posture on the OR table usually, or often, under general anesthesia. And here is an image of the final overlay.
And you can see the visceral and renal arteries with orange circles to identify them. You can remove those, you can remove any of those if you like. This is the workflow. First thing you do is to upload the CT scan to the cloud.
Then, when you're ready to perform the procedure, that is downloaded onto the medical grade PC that's in your OR next to your fluoro screen, and as soon as you just step on the fluoro pedal, the CYDAR overlay appears next to your, or on top of your fluoro image,
next to your regular live fluoro image. And every time you move the table, the computer learning recognizes that the images change, and in a couple of seconds, it replaces with a new overlay based on the obliquity or table position that you have. There are some additional advantages
to cloud-based technology over mechanical technology. First of all, of course, or hardware type technology. Excuse me. You can upgrade it in real time as opposed to needing intermittent hardware upgrades. Works with any fluoro equipment, including a C-arm,
so you don't have to match your 3D imaging to the brand of your fluoro imaging. And there's enhanced accuracy compared to mechanical registration systems as imaging. So what are the clinical applications that this can be utilized for?
Fluoroscopy guided endovascular procedures in the lower thorax, abdomen, and pelvis, so that includes EVAR and FEVAR, mid distal TEVAR. At present, we do need two vertebral bodies and that does limit the use in TEVAR. And then angioplasty stenting and embolization
of common iliac, proximal external and proximal internal iliac artery. Anything where you can acquire a vertebral body image. So here, just a couple of examples of some additional non EVAR/FEVAR/TEVAR applications. This is, these are some cases
of internal iliac embolization, aortoiliac occlusion crossing, standard EVAR, complex EVAR. And I think then, that the final thing that I'd like to talk about is the use with C-arm, which is think is really, extremely important.
Has the potential to make a very big difference. All of us in our larger OR suites, know that we are short on hybrid availability, and yet it's difficult to get our institutions to build us another hybrid room. But if you could use a high quality 3D fusion imaging
with a high quality C-arm, you really expand your endovascular capability within the operating room in a much less expensive way. And then if you look at another set of circumstances where people don't have a hybrid room at all, but do want to be able to offer standard EVAR
to their patients, and perhaps maybe even basic FEVAR, if there is such a thing, and we could use good quality imaging to do that in the absence of an actual hybrid room. That would be extremely valuable to be able to extend good quality care
to patients in under-served areas. So I just was mentioning that we can use this and Tara Mastracci was talking yesterday about how happy she is with her new room where she has the use of CYDAR and an excellent C-arm and she feels that she is able to essentially run two rooms,
two hybrid rooms at once, using the full hybrid room and the C-arm hybrid room. Here's just one case of Dr. Goverde's. A vascular case that he did on a mobile C-arm with aortoiliac occlusive disease and he places kissing stents
using a CYDAR EV and a C-arm. And he used five mils of iodinated contrast. So let's talk about a little bit of data. This is out of Blain Demorell and Tara Mastrachi's group. And this is use of fusion technology in EVAR. And what they found was that the use of fusion imaging
reduced air kerma and DSA runs in standard EVAR. We also looked at our experience recently in EVAR and FEVAR and we compared our results. Pre-availability of image based fusion CT and post image based fusion CT. And just to clarify,
we did have the mechanical product that Phillip's offers, but we abandoned it after using it a half dozen times. So it's really no image fusion versus image fusion to be completely fair. We excluded patients that were urgent/emergent, parallel endographs, and IBEs.
And we looked at radiation exposure, contrast use, fluoro time, and procedure time. The demographics in the two groups were identical. We saw a statistically significant decrease in radiation dose using image based fusion CT. Statistically a significant reduction in fluoro time.
A reduction in contrast volume that looks significant, but was not. I'm guessing because of numbers. And a significantly different reduction in procedure time. So, in conclusion, image based 3D fusion CT decreases radiation exposure, fluoro time,
and procedure time. It does enable 3D overlays in all X-Ray sets, including mobile C-arm, expanding our capabilities for endovascular work. And image based 3D fusion CT has the potential to reduce costs
and improve clinical outcomes. Thank you.
- Thank you very much, Fabrizio. As mentioned, I will talk about the treatment of a type 3b endoleak with an off-label use of a device used in structural heart disease. I don't have any disclosures. I will focus on the type 3b that is caused by
a fabric tear or defect in the fabric, and I will not talk about the graft disintegration. The type 3 endoleak incidence is lower with newer devices, but it has been described with almost all commercially-available devices. And according to literature,
the occurrence can go up almost to 3% of cases. The diagnosis, as I'll show you also with the case, can be quite cumbersome. Often times there is confusion with a type 1 or a type 2 endoleak
that also may be concomitant, and that's where the confusion comes from. The causes are stent fractures, typically suture breakage after implantation of a bare metal stent inside a stent graft or vascular plugs.
And it might also be a manufacturing issue. I'll show you some images from two papers, showing the causes. Usually it's the interaction between the fabric and the metal that makes the fabric tear
and causes the type 3b endoleak as you can clearly see here. Treatment can be very complex, from relining, that might be very challenging, especially when you are very close to the flow divider with the origin of this 3b endoleak. You can put in an aortic cuff
or an iliac limb if that's still possible. Otherwise you need to resort to complete relining using a bifurcated graft, aorto-uni-iliac graft, or off-label use of EVAS. You can also try to seal the fabric tear
by using a pledget in open surgery and something that is similar to the pledget, vascular plug or a septal occluder. And then the final solution would also be conversion. Here are some examples of relining in a bifurcated fashion using an AUI,
which also is a good solution, just like EVAS, as mentioned, off-label. This is an image from a paper from Jones, showing a pledget that was sutured on the fabric tear in an open fashion. And I would like to discuss a patient,
78-year-old male that had a similar problem that was solved by using a vascular plug. This specific patient underwent an EVAR in October, 2009. And then during graft was placed. And a CT in March, 2016 demonstrated a growth of the aneurysm sac,
and also a type 1a endoleak. At least that's what we thought. These are the images from the initial CT scan in March, 2016. You can see a huge filling of the endoleak from proximal. You can see that the stent graft
is actually relatively far away from the left renal artery, which was the lowest renal artery. And on the next pictures you can see that there is actually contrast surrounding the neck, and there is too much space. This was the reason why we decided
to put in an extension cuff in April, 2016. You see some images here. The stent graft was heightened up for about a centimeter or so, and we thought the problem was solved with this. However, a duplex was made,
and to our surprise we saw this image. Flow still in the aneurysm sac from a tiny hole which we thought was a fabric tear. This was actually confirmed by a CT done the same month. And then we planned a procedure. It was relatively easy using the location of the fabric tear
with respect to the marks on the stent graphs to cannulate this tiny hole with a 4 French diagnostic catheter. And you can see on the right-hand side contrast injection clearly demonstrating the 3b endoleak. The sizing should be in such a way
that the device doesn't make the hole that is present a little bit bigger. So we decided to use a relatively small device, 4 French compatible, with a sheath. You can see the sizes, the long axis diameter, that's the A,
the short axis diameter, the B, was three millimeter. And then the unconstrained device length is C, was 6.5 millimeters. And this is actually the segment that will remain inside the aorta, and this is the segment that will go into the aneurysm sac.
And this is actually more or less the thickness of the stent graft. This is a device that is maybe used in the treatment of perivalvular leaks after surgical repair of the aortic valve. But this can also be used,
as I will show you in this case, for this kind of repair of a type 3b endoleak. I put in a 6 French access sheath allowing a 4 French long sheath to move very easily inside. And then we made an exchange of our thicker wire and went inside the endoleak
through the hole with the 4 French sheath. And here you can see advancement of the plug into the aneurysm sac very carefully, because the aortic wall is sitting here. You can see the contrast still being present in the aneurysm sac.
Now with the occlusion it doesn't get out of the sac anymore. Deployment of the distal segment is done first. You can see here the device really popping out, there's a marker on this that indicates the disc that is inside the aneurysm sac now.
Then the proximal segment is deployed by just pulling back the sheath and then you should always test whether it's really holding back by pulling a little bit on the device, and here you can see the device is stretching out.
And the part, the segment inside the aneurysm sac, you can see here with this marker. And this is the other marker on the inside. Then the system is released, you can see the connection still being here connected. And then by unscrewing it you can see
the twisting of the device inside the aorta. And here you can see the segment that is intra-sac. To show it more clearly in the still image, you can see the intra-aortic or intra-stent graft segment, and here is the intra-sac segment. And this occluded the endoleak completely.
Of course, this is off-label use. I show you the image of a follow-up at one year. You can see that there is no endoleak anymore. Actually the space that was here has become a little bit swollen. Sac regression actually didn't occur at this point,
but after two years, you can see that there was sac regression and still absence of an endoleak. So after the type 1a endoleak treatments, it was probably a combined type 1a/3b. With the vascular plug we managed to get
a good and also durable result at two years. This technique has also been described by other people. Richard McWilliams who I saw earlier in the room here used a septal occluder which is a similar device for a similar problem with good outcome. So to conclude,
the diagnosis of type 3b endoleak can be difficult as I demonstrated with this case. There are various endovascular treatment options for relining and embolization with plug-like devices. The occurrence of late type 3b endoleaks underscores again, the need for continuous surveillance after EVAR.
Thank you very much for your attention. (applause) - [Moderator] Thank you Jos. Any questions? Andy, what do you think? - [Andy] Well done, it's fantastic, Jos.
Was there any concern that the wire form of the stent might get in the way and compromise your delivery? - [Jos] Actually that didn't happen, but it was one of my-- - [Andy] You were worried about that, yeah? - [Jos] Yeah, but I got away without a problem, yeah. - [Andy] And cannulating, you said, was surprisingly easy?
- [Jos] It was surprisingly easy, yeah. But I think also here you need to use your pre-interventional imaging. And it was really easy to locate the hole with respect to the markers on the stent graft. And we had quite some of them over there.
- [Andy] I see, of course. Okay, well thanks Jos, that's great.
- Thank you very much. After these beautiful two presentations a 4D ultrasound, it might look very old-fashioned to you. These are my disclosures. Last year, I presented on 4D ultrasound and the way how it can assess wall stress. Now, we know that from a biomechanical point,
it's clear that an aneurysm will rupture when the mechanical stress exceeds the local strength. So, it's important to know something about the state of the aortic wall, the mechanical properties and the stress that's all combined in the wall.
And that could be a better predictor for growth and potential rupture of the aneurysm. It has been performed peak wall stress analysis, using finite element analysis based on CT scan. Now, there has been a test looking at CT scans with and without rupture and given indication
what wall stress could predict in growth and rupture. Unfortunately, there has been no longitudinal studies to validate this system because of the limitations in radiation and nephrotoxic contrast. So, we thought that we could overcome these problems and building the possibilities for longitudinal studies
to do this similar assessment using ultrasound. As you can see here in this diagram in CT scan, mechanical properties and the wall thickness is fixed data based on the literature. Whereas with 3D ultrasound, you can get these mechanical properties from patient-specific imaging
that could give a more patient-specific mechanical AA model. We're still performing a longitudinal study. We started almost four years ago. We're following 320 patients, and every time when they come in surveillance, we perform a 3D ultrasound. I presented last year that we are able to,
with 3D ultrasound, we get adequate anatomy and the geometry is comparable to CT scan, and we get adequate wall stressors and mechanical parameters if we compare it with CT scan. Now, there are still some limitations in 3D ultrasound and that's the limited field of view and the cumbersome procedure and time-consuming procedures
to perform all the segmentation. So last year, we worked on increased field of view and automatic segmentation. As you can see, this is a single image where the aneurysm fits perfectly well in the field of view. But, when the aneurysm is larger, it will not fit
in a single view and you need multi-perspective imaging with multiple images that should be fused and so create one image in all. First, we perform the segmentation of the proximal and distal segment, and that's a segmentation algorithm that is
based on a well-established active deformable contour that was published in 1988 by Kass. Now, this is actually what we're doing. We're taking the proximal segment of the aneurysm. We're taking the distal segment. We perform the segmentation based on the algorithms,
and when we have the two images, we do a registration, sort of a merging of these imaging, first based on the central line. And then afterwards, there is an optimalisation of these images so that they finally perfectly fit on each other.
Once we've done that, we merge these data and we get the merged ultrasound data of a much larger field of view. And after that, we perform the final segmentation, as you can see here. By doing that, we have an increased field of view and we have an automatic segmentation system
that makes the procedure's analysis much and much less time-consuming. We validate it with CT scan and you can see that on the geometry, we have on the single assessment and the multi assessments, we have good similarity images. We also performed a verification on wall stress
and you can see that with these merged images, compared to CT scan, we get very good wall stress assessment compared to CT scan. Now, this is our view to the future. We believe that in a couple of years, we have all the algorithms aligned so that we can perform
a 3D ultrasound of the aorta, and we can see that based on the mechanical parameters that aneurysm is safe, or is maybe at risk, or as you see, when it's red, there is indication for surgery. This is where we want to go.
I give you a short sneak preview that we performed. We started the analysis of a longitudinal study and we're looking at if we could predict growth and rupture. As you can see on the left side, you see that we're looking at the wall stresses. There is no increase in wall stress in the patient
before the aneurysm ruptures. On the other side, there is a clear change in the stiffness of the aneurysm before it ruptures. So, it might be that wall stress is not a predictor for growth and rupture, but that mechanical parameters, like aneurysm stiffness, is a much better predictor.
But we hope to present on that more solid data next year. Thank you very much.
- Thank you very much for the privilege of participating in this iconic symposium. I have no disclosures pertinent to this presentation. The Atelier percutaneous endovascular repair for ruptured abdominal aortic aneurysms is a natural evolution of procedural technique due to the success of fully percutaneous endovascular
aortic aneurysm repair in elective cases. This past year, we had the opportunity to publish our data with regard to 30 day outcomes between percutaneous ruptured aneurysm repairs and surgical cutdown repairs utilizing the American College of Surgeons NSQIP database,
which is a targeted database which enrolls about 800 hospitals in the United States, looking at both the univariate and multivariate analyses comparing preoperative demographics, operative-specific variables and postoperative outcomes. There were 502 patients who underwent
ruptured abdominal aortic aneurysms that were included in this review, 129 that underwent percutaneous repair, whereas 373 underwent cutdown repair. As you can see, the majority were still being done by cutdown.
Over the four years, however, there was a gradual increase in the number of patients that were having percutaneous repair used as their primary modality of access, and in fact a more recent stasis has shown to increase up to 50%,
and there certainly was a learning curve during this period of time. Looking at the baseline characteristics of patients with ruptured aneurysms undergoing both modalities, there was not statistically significant difference
with regard to these baseline characteristics. Likewise, with size of the aneurysms, both were of equal sizes. There was no differences with regard to rupture having hypotension, proximal or distal extension of the aneurysms.
What is interesting, however, that the patients that underwent percutaneous repair tended to have regional anesthesia as their anesthesia of choice, rather than that of having a general. Also there was for some unexplained reason
a more significant conversion to open procedures in the percutaneous group as compared to the cutdown group. Looking at adjusted 30-day outcomes for ruptured endovascular aneurysm repairs, when looking at the 30-day mortality,
the operative time, wound complications, hospital length of stay, that was not statistically significant. However, over that four year period of time, there tended to be decreased hospital length of stay as well as decreased wound complications
over four years. So the summary of this study shows that there was an increased use of fully percutaneous access for endovascular repairs for ruptured aneurysms with noninferiority compared to traditional open femoral cutdown approaches.
There is a trending advantage over conventional surgical exposure with decreased access-related complications, as well as decreased hospital length of stay. Now, I'm going to go through some of the technical tips, and this is really going to be focused upon
the trainees in the room, and also perhaps those clinicians who do not do percutaneous access at this time. What's important, I find, is that the utility of duplex ultrasonography, and this is critical to delineate the common
femoral artery access anatomy. And what's important to find is the common femoral artery between the inguinal ligament and this bifurcation to the profunda femoral and superficial femoral arteries. So this is your target area. Once this target area is found,
especially in those patients presenting with ruptured aneurysm, local anesthesia is preferred over general anesthesia with permissive hypotension. This is a critical point that once you use ultrasound, that you'd want to orient your probe to be
90 degrees to the target area and measure the distance between the skin and the top of that artery. Now if you hold that needle at equidistance to that same distance between the skin and the artery and angle that needle at 45 degrees,
this will then allow you to have the proper trajectory to hit the target absolutely where you're imaging the vessel, and this becomes important so you're not off site. Once micropuncture technique is used, it's always a good idea just to use
a quick fluoroscopic imaging to show that your access is actually where you want it to be. If it's not, you can always re-stick the patient again. Once you have the access in place, what can then happen is do a quick angio to show in fact you have reached the target vessel.
This is the routine instructions for use by placing the percutaneous suture-mediated closure system at 45 degree angles from one another, 90 degrees from one another. Once the sheath is in place for ruptured aneurysm, the placement of a ballon occlusion
can be done utilizing a long, at least 12 French sheath so that they'll keep that balloon up in place. What's also good is to keep a neat operative field, and by doing so, you can keep all of these wires and sutures clean and out of the way and also color code the sutures so that you have
ease and ability to close them later. Finally, it's important to replace the dilator back in the sheath prior to having it removed. This is important just so that if there are problems with your percutaneous closure, you can always very quickly replace your sheath back in.
Again, we tend to color code the sutures so we can know which ones go with which. You can also place yet a third percutaneous access closure device if need be by keeping the guide wire in place. One other little trick that I actually learned
from Ben Starnes when visiting his facility is to utilize a Rumel mediated technique by placing a short piece of IV tubing cut length, running the suture through that, and using it like a Rumel, and that frees up your hand as you're closing up
the other side and final with closure. The contraindications to pREVAR. And I just want to conclude that there's increased use of fully percutaneous access for endovascular repair. There's trending advantages over conventional surgical exposure with decreased
access related complications, and improved outcomes can be attributed to increased user experience and comfort with percutaneous access, and this appears to be a viable first option. Thank you very much.
- Thank you very much and thank you Frank for giving me the opportunity to speak. And I will adapt my talk because I saw some of the slides, I will have to comment of course. So I have no financial disclosures. In many, many papers we know that Endovascular Treatment needs a word
of caution for long-term follow-up and we can see many, many pictures with very good results of viaven or other devices but when you look at the long-term follow-up for this patient, it's quite awful.
So we have late thrombosis just like this, we have curves that goes down and down after 40 or 60 months and much of the patients are very young and so I think it's not a good option. On the contrary, the durability
of open popliteal aneurysm repair has been showed and it's been showed by another of the panelist there and of course I think it's the good way to do and there are several options. The first one, this one, is quite rare
just to make resection with direct anastomosis like this, but it could happen and in this kind of patient, mostly when they are young patients, you don't have to make interposition of any graft.
I mean no vein, no SFA, and no prosthetic grafts. When you have to make some of the conventional open repair just like this, you have to choose between an exclusion graft like this,
I don't like it really much because it can leave a very important aneurysm and it takes a lot of place and it is prone to growing after due to the collaterals
going to the aneurysm sac. Most of the times I like to do something which is a combination of both these two pictures. I mean I like to open the sac to make the aneurysm or if you have the collaterals and then to make a end-to-end
anastomosis at both sides. Of course, when you go to the segment in the gonoral approach you have to make a venous bypass and venous bypass is probably
better when the run-off is awful just like this, but for this patient this was something needing a venous graft and this for me can be treated by synthetic graft because it ends at this level
that mean retroarticular level. So, for the venous graft, I go to venous graft only when I have to make the anastomosis directly on lower-leg vessel just like this and then you mention this
specific paper and if you could read this paper, I'm not one of the first author of this paper because I don't follow this thing because as you say, I think it's not good at all
to section all the muscles and this patient, I know this patient, they can't walk anymore for probably two months, it's not a good option but I'm part of that team and I don't want to defend it for now. Prosthetic bypass is I prefer
because this is very ancient, I agree with you, it's not modern situation, it is very ancient situation but the main thing is that you don't have to cut all the muscles, you have to select patients
with distal neck or retroarticular popliteal artery with good arterial runoff, aminolytic vessels and you have to select the patient and the Angio-CT rather than the angiogram except for
selecting the quality of the run-off. So who should be selected, this kind of patient can be selected because the prosthetic graft will end only here.
And this one could be also, but you can s there is origin of the arteritica artery.
And you have to think at the level of cutting the lower knee popliteal artery. And most of the time you can just externalize the lower knee popliteal artery to make
anastomosis. And then when you make the distal anastomosis, first you can reintegrate after there is the graft. And then the graft in the anastomotic sides goes just below
the level of the endoarticular line just like this. So for me, this is a go even if
you see that it goes just right to the condyles like this. And if you make some pictures with the reflection of the knees, there is no problem for the space. And even when there is a large
length beneath the artery like this. So when (unidentifiable phrase) where there's no vein and no below knee extension. So these are the technique that I expect I already talk about.
This is a small surveys we did I did finally. 20 popliteal arteries, this is the mean diameters. All the patients had good run-off as you can see. And there were only five long bypasses from the common femoral artery.
The other one from the popliteal or distal SFA. This is the mean Length of Stay 4 days only. The limb salvage rate is 100%. Primary patency rates were at one, two and three as 10
and secondary rates were 100% with mean follow-up 2 30 months. So prosthetic bypass is our simple, safe durable options.
I don't cut any muscles for this kind of option. Results compare favorably with our other open and endovascular techniques. And the French survey is going on for now. Thank you very much. (Audience applauds)
- Good morning everybody. Here are my disclosures. So, upper extremity access is an important adjunct for some of the complex endovascular work that we do. It's necessary for chimney approaches, it's necessary for fenestrated at times. Intermittently for TEVAR, and for
what I like to call FEVARCh which is when you combine fenestrated repair with a chimney apporach for thoracoabdominals here in the U.S. Where we're more limited with the devices that we have available in our institutions for most of us. This shows you for a TEVAR with a patient
with an aortic occlusion through a right infracrevicular approach, we're able to place a conduit and then a 22-french dryseal sheath in order to place a TEVAR in a patient with a penetrating ulcer that had ruptured, and had an occluded aorta.
In addition, you can use this for complex techniques in the ascending aorta. Here you see a patient who had a prior heart transplant, developed a pseudoaneurysm in his suture line. We come in through a left axillary approach with our stiff wire.
We have a diagnostic catheter through the femoral. We're able to place a couple cuffs in an off-label fashion to treat this with a technically good result. For FEVARCh, as I mentioned, it's a good combination for a fenestrated repair.
Here you have a type IV thoraco fenestrated in place with a chimney in the left renal, we get additional seal zone up above the celiac this way. Here you see the vessels cannulated. And then with a nice type IV repaired in endovascular fashion, using a combination of techniques.
But the questions always arise. Which side? Which vessel? What's the stroke risk? How can we try to be as conscientious as possible to minimize those risks? Excuse me. So, anecdotally the right side has been less safe,
or concerned that it causes more troubles, but we feel like it's easier to work from the right side. Sorry. When you look at the image intensifier as it's coming in from the patient's left, we can all be together on the patient's right. We don't have to work underneath the image intensifier,
and felt like right was a better approach. So, can we minimize stroke risk for either side, but can we minimize stroke risk in general? So, what we typically do is tuck both arms, makes lateral imaging a lot easier to do rather than having an arm out.
Our anesthesiologist, although we try not to help them too much, but it actually makes it easier for them to have both arms available. When we look at which vessel is the best to use to try to do these techniques, we felt that the subclavian artery is a big challenge,
just the way it is above the clavicle, to be able to get multiple devices through there. We usually feel that the brachial artery's too small. Especially if you're going to place more than one sheath. So we like to call, at our institution, the Goldilocks phenomenon for those of you
who know that story, and the axillary artery is just right. And that's the one that we use. When we use only one or two sheaths we just do a direct puncture. Usually through a previously placed pledgeted stitch. It's a fairly easy exposure just through the pec major.
Split that muscle then divide the pec minor, and can get there relatively easily. This is what that looks like. You can see after a sheath's been removed, a pledgeted suture has been tied down and we get good hemostasis this way.
If we're going to use more than two sheaths, we prefer an axillary conduit, and here you see that approach. We use the self-sealing graft. Whenever I have more than two sheaths in, I always label the sheaths because
I can't remember what's in what vessel. So, you can see yes, I made there, I have another one labeled right renal, just so I can remember which sheath is in which vessel. We always navigate the arch first now. So we get all of our sheaths across the arch
before we selective catheterize the visceral vessels. We think this partly helps minimize that risk. Obviously, any arch manipulation is a concern, but if we can get everything done at once and then we can focus on the visceral segment. We feel like that's a better approach and seems
to be better for what we've done in our experience. So here's our results over the past five-ish years or so. Almost 400 aortic interventions total, with 72 of them requiring some sort of upper extremity access for different procedures. One for placement of zone zero device, which I showed you,
sac embolization, and two for imaging. We have these number of patients, and then all these chimney grafts that have been placed in different vessels. Here's the patients with different number of branches. Our access you can see here, with the majority
being done through right axillary approach. The technical success was high, mortality rate was reasonable in this group of patients. With the strokes being listed there. One rupture, which is treated with a covered stent. The strokes, two were ischemic,
one hemorrhagic, and one mixed. When you compare the group to our initial group, more women, longer hospital stay, more of the patients had prior aortic interventions, and the mortality rate was higher. So in conclusion, we think that
this is technically feasible to do. That right side is just as safe as left side, and that potentially the right side is better for type III arches. Thank you very much.
- Relevant disclosures are shown in this slide. So when we treat patients with Multi-Segment Disease, the more segments that are involved, the more complex the outcomes that we should expect, with regards to the patient comorbidities and the complexity of the operation. And this is made even more complex
when we add aortic dissection to the patient population. We know that a large proportion of patients who undergo Thoracic Endovascular Aortic Repair, require planned coverage of the left subclavian artery. And this also been demonstrated that it's an increase risk for stroke, spinal cord ischemia and other complications.
What are the options when we have to cover the left subclavian artery? Well we can just cover the artery, we no that. That's commonly performed in emergency situations. The current standard is to bypass or transpose the artery. Or provide a totally endovascular revascularization option
with some off-label use , such as In Situ or In Vitro Fenestration, Parallel Grafting or hopefully soon we will see and will have available branched graft devices. These devices are currently investigational and the focus today's talk will be this one,
the Valiant Mona Lisa Stent Graft System. Currently the main body device is available in diameters between thirty and forty-six millimeters and they are all fifteen centimeters long. The device is designed with flexible cuff, which mimics what we call the "volcano" on the main body.
It's a pivotal connection. And it's a two wire pre-loaded system with a main system wire and a wire through the left subclavian artery branch. And this has predominately been delivered with a through and through wire of
that left subclavian branch. The system is based on the valiant device with tip capture. The left subclavian artery branch is also unique to this system. It's a nitinol helical stent, with polyester fabric. It has a proximal flare,
which allows fixation in that volcano cone. Comes in three diameters and they're all the same length, forty millimeters, with a fifteen french profile. The delivery system, which is delivered from the groin, same access point as the main body device. We did complete the early feasibility study
with nine subjects at three sites. The goals were to validate the procedure, assess safety, and collect imaging data. We did publish that a couple of years ago. Here's a case demonstration. This was a sixty-nine year old female
with a descending thoracic aneurysm at five and a half centimeters. The patient's anatomy met the criteria. We selected a thirty-four millimeter diameter device, with a twelve millimeter branch. And we chose to extend this repair down to the celiac artery
in this patient. The pre-operative CT scan looks like this. The aneurysm looks bigger with thrombus in it of course, but that was the device we got around the corner of that arch to get our seal. Access is obtained both from the groin
and from the arm as is common with many TEVAR procedures. Here we have the device up in the aorta. There's our access from the arm. We had a separate puncture for a "pigtail". Once the device is in position, we "snare" the wire, we confirm that we don't have
any "wire wrap". You can see we went into a areal position to doubly confirm that. And then the device is expanded, and as it's on sheath, it does creep forward a bit. And we have capture with that through and through wire
and tension on that through and through wire, while we expand the rest of the device. And you can see that the volcano is aligned right underneath the left subclavian artery. There's markers there where there's two rings, the outer and the inner ring of that volcano.
Once the device is deployed with that through and through wire access, we deliver the branch into the left subclavian artery. This is a slow deployment, so that we align the flair within the volcano and that volcano is flexible. In some patients, it sort of sits right at the level of
the aorta, like you see in this patient. Sometimes it protrudes. It doesn't really matter, as long as the two things are mated together. There is some flexibility built in the system. In this particular patient,
we had a little leak, so we were able to balloon this as we would any others. For a TEVAR, we just balloon both devices at the same time. Completion Angiogram shown here and we had an excellent result with this patient at six months and at a year the aneurysm continued
to re-sorb. In that series, we had successful delivery and deployment of all the devices. The duration of the procedure has improved with time. Several of these patients required an extension. We are in the feasibility phase.
We've added additional centers and we continue to enroll patients. And one of the things that we've learned is that details about the association between branches and the disease are critical. And patient selection is critical.
And we will continue to complete enrollment for the feasibility and hopefully we will see the pivotal studies start soon. Thank you very much
- [Narrator] Good morning everyone. Again, thank you Dr. Veith for inviting me for this legendary meeting. I just love your meeting, thank you very much. Here you have my disclosures, I have said that the T-Branch device from Cook is not commercialized in the US
but it is in South America, now it's in Europe. Our presentation today is based in our article published German Vascular Therapy last year in August, Advanced technical considerations for implanting the T-branch off the shelf.
Branches stent-graft to treat Thoracoabdominal Aneurysms. I'm sure most of you already know this device. It's a off the shelf device from Cook. It has 202 millimeters in length. The proximal stent is 34 millimeters, the distal stent is 18 millimeters.
Of course, it has also four downward branch, so you have to adapt the anatomy of your patient and then to use this device in many situations. Here is a simple example, you can use this device in perirenal or superrenal aneurysms type 4. Just cutting one or two of the proximal stents.
Just be aware to (mumbles) the device in the (mumbles). So you can avoid the migration of the device. That's a good way to diminish the risks of paraplegia for you patient. The same way you can now cut the distal portion one or two stents, so and in cases you have
a previous device, you can pipe one in the leak, is we can show in cases, maxes lights, you can use this device. Also, the second component to anybody of the device, the bifurcated component can be cut. You can cut the proximal stents, you can cut
the distal stents, you can make that straight graft. So just like that, use it in many circumstances. And this is one of the maneuvers we use very often. We call that device driven by the sheath because you do a through and through wire and then you put that set the nose of our device
inside the sheath that come from the arm. So it helps by the avoid your device to touch the aort wall or even devices previously inserted. And also allow you to rotate the device to a correct position. Another maneuver is snare-ride technique that
we have already described in the Journal Endovascular Therapy last year. It's a very simple way so we can bring from the femoral access, we can bring the snare inside the one artery and that snare can capture a wire come from the arm, so we can
hold the position inside the target vessel. Here, an example that you can see all those maneuvers. This patient has a previous I-stent surgery and then the device that is probably the false lumen all the vessels come from this true lumen, which is secluded like capsule decortication.
They have minimal aortic communication. They've going to seen more details in the next slides. So here you can see the case that is a communication close to the celiac track and then is stuck. And then you have another communication, the intrarenal aort are very thin.
So here is a draw, you can see the first challenge was could we move a sheath, 12 branch sheath across the (mumbles) in the thin aorta and put that in the thin aorta, so without that, we could not do the case. We start the case doing that and as you can see,
we see that it was possible to do that, so we continue in the case. Following are challenges you will face was would we be able to cross this aort, very thin channel and to go there, to put the device here, and then to put the t-branch device to
all the branches from this true lumen. So here is our study, our plan was if you cross that communication, we put a t-branch here and used the celiac branch to TAAAs. Left renal artery, the celiac branch, the mysentary to branch the celiac artery, the left renal branch
to the mysentary artery and then right renal branch to right renal branch. So, that proves to be feasible. We could graft that communication and that adversary straight device to start the (cuts off). So here you see that the things
happened exactly as we planned it. The celiac was done by the SMA branch, the SMA done by the left renal, and the right renal by the right renal. At that point, we consider the game over. (cuts off) who could try the
celiac branch to the left renal. The angle was not preferable, so we come from the femoral artery in have access to left renal and open (mumbles) there and the diverse that wire should be put inside the left renal. Here you see the maneuver completed.
We advanced and hold the stent so we can have this branch also done. Here, you have a closed view of the left renal branch done by the celiac branch of the device. And now we have the final result of the branch done. How the bifurcate the device of completely
excluding the false movement of this complex dissection. So to illustrate this presentation, I bring you the control, one week control of this patient and could we fold the breasts where (mumbles) did it in the dissection, totally excluded from the circulation.
So, in conclusion ladies and gentlemen, I would say that the use of the branched stent-grafts in the treatment of Thoracoabdominal use is proven feasible, safe, and the off-the-shelf multibranched t-branch can be used in both urgent and elective scenarios.
Employing adjunctive maneuvers can increase the anatomic suitability of rience, these techniques have increased the applicability to 80 percent of the cases, included dissections of the small lumen.
I want to thank you all for your kind attention. Thank you, again, Frank for accepting my talk recorded. And I'm very pleased to answer questions by email or WhatsApp as you can see, this is live. Thank you very much.
- These are my disclosures. So aortic neck dilatation is not a new problem. It's been described even before the era of endovascular repair and it's estimated to occur in about 20% of all patients that undergo EVAR two years after the index procedure.
We're seeing more and more cases where patients that survive long enough after EVAR, they develop aortic neck dilatation beyond the nominal diameter of the endograft and like on this patient, this image, large type 1A endoleaks that are difficult to treat.
There's a number of factors that are contributing to aortic neck dilatation including a continuous outward force that is exerted by the endograft. Progression of aortic wall degeneration. Aneurisymal disease is a degenerative procedure.
The presence of endoleaks, particularly type two endoleaks have been implicated in aortic neck dilatation. And then incomplete seal at the proximal neck in the form of microleaks or positional leaks. HeliFX EndoAnchors as you heard were
designed to stabilize and improve the apposition of the endograft to the aortic neck. And as you saw on this video, their presence even when the super no fixation disengages from the wall of the aorta, may help stabilize the graft onto
the aorta and prevent type 1A endoleaks. About three or four years ago we started looking at the anchor registry data, trying to identify predictors of aortic neck dilatation in patients who are undergoing EVAR with EndoAnchors. We published those results about a year ago.
In terms of the one year mark, we had 267 patients in that cohort. We measured the aortic diameter at four different levels. 20 millimeters proximal to the lowest main renal artery and then at the level of the lowest renal artery, five and 10 millimeters distal to that.
We defined the change in diameter that occurred between the pre-implantation EVAR and the first post-implantation EVAR at about one month. As adoptive enlargement due mainly to the effect of endograaft and the interaction with the aortic wall.
And then we defined this dilatation, what occurred between the one month and the 12 month mark, post EVAR. We used 20 different variables and we ran all these variables at the three levels. And what we found in terms of
post-operative neck dilatation is that it occurred in 3.1% of patients at the level of the lowest renal artery. 7.7% five millimeters distal to it and 4.6% at 10 millimeters distal to it. And this is a dilatation with a threshold
of at least three millimeters. We felt that this was much more clinically relevant. In terms of protective factors for adaptive enlargement, the presence of calcium and the aortic diameter of the level of the lowest renal, both of these are easy to understand.
The stiffer the aorta, the lesser the degree of the immediate dilatation. But then when we looked at the true dilatation, we found out that the aortic neck diameter at the lowest renal artery was a significant risk factor as was Endograft oversizing.
So if you started with a large aorta to begin with, these patients were much more likely to develop neck dilatation and if you significantly oversize the endograft that was also an independent risk factor. On the other hand, the neck length as well as the number of EndoAnchors that
were placed in these patients, both appear to have independent protective effects. So the two year preliminary analysis results is what I'm going to present. The analysis is still ongoing, but now we have a larger number of patients, 674.
We performed the same measurements at the same levels. What we found in terms of time course and location of the aortic neck dilatation is that in the suprarenal site, there is negligible dilatation up to 24 months. The largest dilatation occurs at five millimeters,
but more interestingly, a significant number of patients did not even have endograft present in that location. And then at 10 millimeters distal to the lowest renal artery right where most of the aneurysm changes you would expect to occur,
that change in diameter was again negligible. Indirectly suggesting that EndoAnchors have protective effect. So these are our interesting, some interesting insights. Female sex and graft oversize do play a significant role in the post-operative neck dilatation.
With EndoAnchors implanted at the index procedure neck dilatation 10 millimeters distal to the lowest renal artery appears to be negligible both at 12 and at 24 months. But we're working to see a little bit more finer elements at this analysis.
As where exactly the EndoAnchors were placed and how this was associated with the changes in the aortic neck. We hope to have those results later this year. Thank you.
- [Professor Veith] Laura, Welcome. - Thank you Professor Veith, thank you to everybody and good morning. It's a great pleasure, to have the possibility to present the result of this randomized trial we performed near Rome in Italy.
Risk of CAS-related embolism was maximal during the first phases of the second procedure, the filter positioning predilation and deployment and post dilatation. But it continues over time with nithinol expansion so that we have an interaction between the stent struts
and the plaque that can last up to 28 or 30 days that is the so called plaque healing period. This is why over time different technique and devices have been developed in order to keep to a minimum the rate of perioperative neurological embolization.
This is why we have, nowadays, membrane-covered stent or mesh-covered stent. But a question we have to answer, in our days are, "are mesh covered stents able to capture every kind of embolism?" Even the off-table one.
This is why they have been designed. That is to say the embolism that occurs after the patient has left the operating room. This is why we started this randomized trial with the aim of comparing the rate of off-table subclinical neurological events
in two groups of patients submitted to CAS with CGuard or WALLSTENT and distal embolic protection device in all of them. We enrolled patient affected by asymptomatic carotid stenosis more than 70% and no previous brain ischemic lesion
detected at preoperative DW-MRI. The primary outcome was the rate of perioperative up to 72 hour post peri operatively in neurological ischemic events detected by DW-MRI in the two CAS group. And secondary outcome measure were the rise of (mumbles)
neuro biomarker as one on the better protein in NSE and the variation in post procedural mini mental state examination test in MoCA test score We enrolled 29 patients for each treatment group. The study protocol was composed by a preoperative DW-MRI and neuro psychometrics test assessment
and the assessment of blood levels of this two neuro biomarkers. Then, after the CAS procedure, we performed an immediate postoperative DW-MRI, we collect this sample up to 48 hours post operatively to assess the level of the neuro biomarkers
then assess 72 hour postoperatively we perform a new DW-MRI and a new assessment of neuro psychometric tests. 58 patient were randomized 29 per group. And we found one minor stroke in the CGuard group together with eight clinically silent lesion detected at 72 hours DW-MRI.
Seven patient presented in WALLSTENT group silent 72 DW-MRI lesion were no difference between the two groups but interestingly two patients presented immediately postoperatively DW-MRI lesions. Those lesion were no more detectable at 72 hours
this give doubts to what we are going to see with DW-MRI. When analyzing the side of the lesion, we found four ipsilateral lesion in the CGuard patient and four contra or bilateral lesion in this group while four ipsilateral were encountered in WALLSTENT patient and three contra or bilateral lesion
in the WALLSTENT group were no difference between the two groups. And as for the diameter of the lesion, there were incomparable in the two groups but more than five lesion were found in five CGuard patients, three WALLSTENT patient
with no significant difference within the two groups. A rise doubled of S1 of the better protein was observed at 48 hours in 24 patients, 12 of them presenting new DW-MRI lesions. And this was statistically significant when comparing the 48 level with the bars of one.
When comparing results between the two groups for the tests, we found for pre and post for MMSE and MoCA test no significant difference even if WALLSTENT patients presented better MoCA test post operatively and no significant difference for the postoperative score for both the neuro psychometric test between the two groups.
But when splitting patients not according to the treatment group but according to the presence of more or less than 5 lesion at DW-MRI, we found a significant difference in the postoperative score for both MMSE and MoCA test between both group pf patients.
To conclude, WALLSTENT and CGuard stent showed that not significant differences in micro embolism rate or micro emboli number at 72 postoperative hours DW-MRI, in our experience. 72 hour DW-MMRI lesion were associated to an increase in neuro biomarkers
and more than five lesion were significantly associated to a decrease in neuro psychometric postoperative score in both stent groups. But a not negligible number of bilateral or contralateral lesions were detected in both stent groups This is very important.
This is why, probably, (mumbles) are right when they show us what really happened into the arch when we perform a transfer more CAS and this is why, maybe,
the future can be to completely avoid the arch. I thank you for your attention.
- These are my disclosures. So central venous access is frequently employed throughout the world for a variety of purposes. These catheters range anywhere between seven and 11 French sheaths. And it's recognized, even in the best case scenario, that there are iatrogenic arterial injuries
that can occur, ranging between three to 5%. And even a smaller proportion of patients will present after complications from access with either a pseudoaneurysm, fistula formation, dissection, or distal embolization. In thinking about these, as you see these as consultations
on your service, our thoughts are to think about it in four primary things. Number one is the anatomic location, and I think imaging is very helpful. This is a vas cath in the carotid artery. The second is th
how long the device has been dwelling in the carotid or the subclavian circulation. Assessment for thrombus around the catheter, and then obviously the size of the hole and the size of the catheter.
Several years ago we undertook a retrospective review and looked at this, and we looked at all carotid, subclavian, and innominate iatrogenic injuries, and we excluded all the injuries that were treated, that were manifest early and treated with just manual compression.
It's a small cohort of patients, we had 12 cases. Eight were treated with a variety of endovascular techniques and four were treated with open surgery. So, to illustrate our approach, I thought what I would do is just show you four cases on how we treated some of these types of problems.
The first one is a 75 year-old gentleman who's three days status post a coronary bypass graft with a LIMA graft to his LAD. He had a cordis catheter in his chest on the left side, which was discovered to be in the left subclavian artery as opposed to the vein.
So this nine French sheath, this is the imaging showing where the entry site is, just underneath the clavicle. You can see the vertebral and the IMA are both patent. And this is an angiogram from a catheter with which was placed in the femoral artery at the time that we were going to take care of this
with a four French catheter. For this case, we had duel access, so we had access from the groin with a sheath and a wire in place in case we needed to treat this from below. Then from above, we rewired the cordis catheter,
placed a suture-mediated closure device, sutured it down, left the wire in place, and shot this angiogram, which you can see very clearly has now taken care of the bleeding site. There's some pinching here after the wire was removed,
this abated without any difficulty. Second case is a 26 year-old woman with a diagnosis of vascular EDS. She presented to the operating room for a small bowel obstruction. Anesthesia has tried to attempt to put a central venous
catheter access in there. There unfortunately was an injury to the right subclavian vein. After she recovered from her operation, on cross sectional imaging you can see that she has this large pseudoaneurysm
coming from the subclavian artery on this axial cut and also on the sagittal view. Because she's a vascular EDS patient, we did this open brachial approach. We placed a stent graft across the area of injury to exclude the aneurism.
And you can see that there's still some filling in this region here. And it appeared to be coming from the internal mammary artery. We gave her a few days, it still was patent. Cross-sectional imaging confirmed this,
and so this was eventually treated with thoracoscopic clipping and resolved flow into the aneurism. The next case is a little bit more complicated. This is an 80 year-old woman with polycythemia vera who had a plasmapheresis catheter,
nine French sheath placed on the left subclavian artery which was diagnosed five days post procedure when she presented with a posterior circulation stroke. As you can see on the imaging, her vertebral's open, her mammary's open, she has this catheter in the significant clot
in this region. To manage this, again, we did duel access. So right femoral approach, left brachial approach. We placed the filter element in the vertebral artery. Balloon occlusion of the subclavian, and then a stent graft coverage of the area
and took the plasmapheresis catheter out and then suction embolectomy. And then the last case is a 47 year-old woman who had an attempted right subclavian vein access and it was known that she had a pulsatile mass in the supraclavicular fossa.
Was noted to have a 3cm subclavian artery pseudoaneurysm. Very broad base, short neck, and we elected to treat this with open surgical technique. So I think as you see these consults, the things to factor in to your management decision are: number one, the location.
Number two, the complication of whether it's thrombus, pseudoaneurysm, or fistula. It's very important to identify whether there is pericatheter thrombus. There's a variety of techniques available for treatment, ranging from manual compression,
endovascular techniques, and open repair. I think the primary point here is the prevention with ultrasound guidance is very important when placing these catheters. Thank you. (clapping)
- The FLEX Scoring Catheter is one of the new tools, which is dedicated to vessel preparation, either as a stent, as a therapy followed by plain balloon angioplasty, or preparing the vessel for drug-eluting balloons and stents. So, the background basically is that
we're more and more tackling chronic total occlusions, and these kind of lesions, they have an increased risk of being calcium-containing, creating dissections, perforations, embolization, and poor luminal gain. And for that purpose, this device, which is more or less
a kind of surgical device, was developed. It's a interventional tool which can be introduced via a six-French sheath. It's an over-the-wire system, running over a 14 or 18 thousandths guide wire. It's common in shaft lengths of
40 centimeters dedicated to AV, fistula treatment and 120 centimeters, and the device is exposed to the vessel wall with three atherotomes, with the indication for femoropopiliteal and AV fistula excess treatment. One size fits all is really the right description
of this device, except having two different shaft lengths, the device itself is coming in one size only. What does it result in? Well, it results in micro-incisions, as you can see it over here, also over here in an OCT image, and the depths of these incisions
is about 0.5 millimeters, the pressure which is applied to the surface is about one atmosphere, independent on the vessel size. So, the idea and the rationale for this device is to facilitate and increase the vessel compliance and to create an controlled environment for angioplasty.
There are, just recently, some specimen analysis performed by CBSET, what you can see over here, marked by arrows, these arrows indicate the FLEX-induced micro-incisions, and you can see that these incisions are really circumferential with controlled,
uniform depths of those incisions into the plaque or the vessel wall. This is a 150 times magnification and you can see these longitudinal micro-incisions, which are very much parallel, it's like using a cutting balloon,
the advantage, however, is that this device can be applied to even longer lesions, the limitation of a cutting balloon is the balloon length of 20 centimeters only. So what are the early results? I can present you the acute outcomes
of 100 patients' sample size, with chronic total femoropopliteal occlusions. We can see that the average lesion length was really significant, 191 millimeters, the range was up to 35 centimeters, and there was moderate to severe calcification
in almost 50% of those cases. The luminal gain post FLEX application was about 31%, and the following balloon opening pressure, which was documented within this registry, was four atmospheres only, which is a signal that really the vessel compliance
is significantly improved, considering the almost 50% of moderate to severe calcification of those lesions. There had been no emboli, there had been no flow-limiting dissections, nevertheless, the provisional stent use was still high with 19%.
This is one of two case examples I would like to share with you. This was an instant re-occlusion of the popliteal artery, 10 centimeters in length, this was passed with an 18 thousandths guide wire, three passes with the FLEX catheter had been performed,
as you can see over here. And this was then, this was the result after FLEX catheter application and this is post additional drug-coated balloon angioplasty, there was no dissection, there was no significant residual stenosis.
Another case example, unfortunately, the video will not run, this was a long distance flush occlusion of the SFA, and you can see the calcium here in the entire length of the lesion, this lesion was treated, again, with the FLEX catheter, here, the video is not running,
this is the final result after DCB application. So, in summary, there's a high degree of technical success in achieving consistent luminal gain post FLEX, there's a low opening balloon pressure, and the re-canalization of CTOs was possible with a low rate, zero rate of significant dissections
and the low provisional stent rate. Thank you very much.
Disclaimer: Content and materials on Medlantis are provided for educational purposes only, and are intended for use by medical professionals, not to be used self-diagnosis or self-treatment. It is not intended as, nor should it be, a substitute for independent professional medical care. Medical practitioners must make their own independent assessment before suggesting a diagnosis or recommending or instituting a course of treatment. The content and materials on Medlantis should not in any way be seen as a replacement for consultation with colleagues or other sources, or as a substitute for conventional training and study.