[Mollie Meek] We are going to talk about our histology of head and neck AVMs after Onyx embolization. Like I said previously, we were in love with Onyx at the end of the 2000's. So we used lots and lots of Onyx, and then the patients generally went for resection.
Sometimes immediately, and sometimes years after the embolization. We are not as in love with Onyx anymore, and our hospital was certainly not in love with us using Onyx the way we were using it in the past, because it was super expensive,
and they weren't getting reimbursed for the multiple vials we were using. I had no disclosures. If I have time, I'll talk to you about radiation dose. The most important part is the pathological response. This is a slide of a typical AVM.
You see the thick walled arterial portion of the vascular channels and the thinner walled venous portion. This is just a higher magnification. I am not a pathologist. So when we did our scoring of our specimens,
we scored some acute and inflammatory changes, some chronic inflammatory changes, and then the amount of recanalization that we saw. What we found is that recanalization was extremely common. We saw it in 13 of our 18 specimens,
and the specimens that had minimal inflammatory changes had minimal recanalization. That's the take home message. This is a specimen with Onyx in cast material in the vessels. Trying not to blind our moderators like I did earlier.
This is a really pretty picture of the vessel wall, the Onyx material, and a brand new vessel in the middle of this old vessel. This is what just sort of a scout image of what their faces looked like.
One of, a sample. This is like a longitudinal slice of a vessel. So this is vessel wall on one side, vessel wall on the other side, Onyx material, and then new vessel formation
and interstitial tissue stuff in the middle of that old, big vessel. These are just some pictures. Another example of Onyx with vessels inside the Onyx. We saw a fair amount of giant cell formation, which you can kind of see these clusters
of multi nucleated things, are the giant cells. They come in and clean up the Onyx material. These are just more Onyx specimens. Here's a nice picture of giant cell. We also counted vessel wall necrosis in our tabulations.
And you can see this Onyx material is in the endothelial cells, and it kills the endothelial cells. So we did see some vessel wall necrosis. So the short story is there's no definitive time for the recanalization,
but we think it takes about a year for you to really see nicely formed vessels in the Onyx. And in our experience in the head and neck, it was common. It may be different in other locations, because obviously your head and neck
has different lymphatic ratios and inflammatory things, and there's all kinds of differences between the head and neck, and say your arm or your leg. The second part of this is your radiation dose,
which has been touched on a little bit. The plug and push technique, part of why I don't like it, and why I don't like using Onyx, is it's just slow. You have to wait, and wait.
And it takes a lot of x-ray penetration, because your computer is going to try to up your dose because you've got the black Onyx in the x-ray beam, if that makes any sense. Your machine's going to try to help you, and it amps up your dose
really quickly if you're not careful. And for our head and neck patients, obviously we're doing AP and lateral views. This is our equipment. We put dots, radiation dosimeters on peoples' heads
and one in their oropharynx before our treatments, and we did calculations of a sequence of patients. You can see the ages of the patients in the group, and the number of the patients. This was just for a short time period we did this.
This is the important part, that the AVMs have a much higher skin entrance dose than the venous malfs. Part of that is we don't put on in venous mals. Sometimes I will put glue in a venous mal if a surgeon wants to resect it
because they like the way it comes out when you do that. But otherwise I generally just use alcohol in venous mals. And then these were on X AVMs at this point in time when we collected this data. Some alcohol.
This is a reminder about the dosimetry. And this was the number of sessions, embolization sessions versus the skin entrance dose. And just some more pictures of yeah. So Onyx is not permanent in my histologic experience.
Watch out for wound healing issues and recanalization, and watch out for skin burns. That's it. Thanks.
- Thanks Dr. Weaver. Thank you Dr. Reed for the invitation, once again, to this great meeting. These are my disclosures. So, open surgical repair of descending aortic arch disease still carries some significant morbidity and mortality.
And obviously TEVAR as we have mentioned in many of the presentations has become the treatment of choice for appropriate thoracic lesions, but still has some significant limitations of seal in the aortic arch and more techniques are being developed to address that.
Right now, we also need to cover the left subclavian artery and encroach or cover the left common carotid artery for optimal seal, if that's the area that we're trying to address. So zone 2, which is the one that's,
it is most commonly used as seal for the aortic arch requires accurate device deployment to maximize the seal and really avoid ultimately, coverage of the left common carotid artery and have to address it as an emergency. Seal, in many of these cases is not maximized
due to the concern of occlusion of the left common carotid artery and many of the devices are deployed without obtaining maximum seal in that particular area. Failure of accurate deployment often leads to a type IA endoleak or inadvertent coverage
of the left common carotid artery which can become a significant problem. The most common hybrid procedures in this group of patients include the use of TEVAR, a carotid-subclavian reconstruction and left common carotid artery stenting,
which is hopefully mostly planned, but many of the times, especially when you're starting, it may be completely unplanned. The left common carotid chimney has been increasingly used to obtain a better seal
in this particular group of patients with challenging arches, but there's still significant concerns, including patients having super-vascular complications, stroke, Type A retrograde dissections and a persistent Type IA endoleak
which can be very challenging to be able to correct. There's limited data to discuss this specific topic, but some of the recent publications included a series of 11 to 13 years of treatment with a variety of chimneys.
And these publications suggest that the left common carotid chimneys are the most commonly used chimneys in the aortic arch, being used 76% to 89% of the time in these series. We can also look at these and the technical success
is very good. Mortality's very low. The stroke rate is quite variable depending on the series and chimney patency's very good. But we still have a relatively high persistent
Type IA endoleak on these procedures. So what can we do to try to improve the results that we have? And some of these techniques are clearly applicable for elective or emergency procedures. In the elective setting,
an open left carotid access and subclavian access can be obtained via a supraclavicular approach. And then a subclavian transposition or a carotid-subclavian bypass can be performed in preparation for the endovascular repair. Following that reconstruction,
retrograde access to left common carotid artery can be very helpful with a 7 French sheath and this can be used for diagnostic and therapeutic purposes at the same time. The 7 French sheath can easily accommodate most of the available covered and uncovered
balloon expandable stents if the situation arises that it's necessary. Alignment of the TEVAR is critical with maximum seal and accurate placement of the TEVAR at this location is paramount to be able to have a good result.
At that point, the left common carotid artery chimney can be deployed under control of the left common carotid artery. To avoid any embolization, the carotid can be flushed, primary repaired, and the subclavian can be addressed
if there is concern of a persistent retrograde leak with embolization with a plug or other devices. The order can be changed for the procedure to be able to be done emergently as it is in this 46 year old policeman with hypertension and a ruptured thoracic aneurism.
The patient had the left common carotid access first, the device deployed appropriately, and the carotid-subclavian bypass performed in a more elective fashion after the rupture had been addressed. So, in conclusion, carotid chimney's and TEVAR
combination is a frequently used to obtain additional seal on the aortic arch, with pretty good results. Early retrograde left common carotid access allows safe TEVAR deployment with maximum seal,
and the procedure can be safely performed with low morbidity and mortality if we select the patients appropriately. Thank you very much.
- Thank you very much for the opportunity to speak carbon dioxide angiography, which is one of my favorite topics and today I will like to talk to you about the value of CO2 angiography for abdominal and pelvic trauma and why and how to use carbon dioxide angiography with massive bleeding and when to supplement CO2 with iodinated contrast.
Disclosures, none. The value of CO2 angiography, what are the advantages perhaps? Carbon dioxide is non-allergic and non-nephrotoxic contrast agent, meaning CO2 is the only proven safe contrast in patients with a contrast allergy and the renal failure.
Carbon dioxide is very highly soluble (20 to 30 times more soluble than oxygen). It's very low viscosity, which is a very unique physical property that you can take advantage of it in doing angiography and CO2 is 1/400 iodinated contrast in viscosity.
Because of low viscosity, now we can use smaller catheter, like a micro-catheter, coaxially to the angiogram using end hole catheter. You do not need five hole catheter such as Pigtail. Also, because of low viscosity, you can detect bleeding much more efficiently.
It demonstrates to the aneurysm and arteriovenous fistula. The other interesting part of the CO2 when you inject in the vessel the CO2 basically refluxes back so you can see the more central vessel. In other words, when you inject contrast, you see only forward vessel, whereas when you inject CO2,
you do a pass with not only peripheral vessels and also see more central vessels. So basically you see the vessels around the lesions and you can use unlimited volumes of CO2 if you separate two to three minutes because CO2 is exhaled by the respirations
so basically you can inject large volumes particularly when you have long prolonged procedures, and most importantly, CO2 is very inexpensive. Where there are basically two methods that will deliver CO2. One is the plastic bag system which you basically fill up with a CO2 tank three times and then empty three times
and keep the fourth time and then you connect to the delivery system and basically closest inject for DSA. The other devices, the CO2mmander with the angio assist, which I saw in the booth outside. That's FDA approved for CO2 injections and is very convenient to use.
It's called CO2mmander. So, most of the CO2 angios can be done with end hole catheter. So basically you eliminate the need for pigtail. You can use any of these cobra catheters, shepherd hook and the Simmons.
If you look at this image in the Levitor study with vascular model, when you inject end hole catheter when the CO2 exits from the tip of catheter, it forms very homogenous bolus, displaces the blood because you're imaging the blood vessel by displacing blood with contrast is mixed with blood, therefore as CO2
travels distally it maintains the CO2 density whereas contrast dilutes and lose the densities. So we recommend end hole catheter. So that means you can do an arteriogram with end hole catheter and then do a select arteriogram. You don't need to replace the pigtail
for selective injection following your aortographies. Here's the basic techniques: Now when you do CO2 angiogram, trauma patient, abdominal/pelvic traumas, start with CO2 aortography. You'll be surprised, you'll see many of those bleeding on aortogram, and also you can repeat, if necessary,
with CO2 at the multiple different levels like, celiac, renal, or aortic bifurcation but be sure to inject below diaphragm. Do not go above diaphragm, for example, thoracic aorta coronary, and brachial, and the subclavian if you inject CO2, you'll have some serious problems.
So stay below the diaphragm as an arterial contrast. Selective injection iodinated contrast for a road map. We like to do super selective arteriogram for embolization et cetera. Then use a contrast to get anomalies. Super selective injection with iodinated contrast
before embolization if there's no bleeding then repeat with CO2 because of low viscocity and also explosion of the gas you will often see the bleeding. That makes it more comfortable before embolization. Here is a splenic trauma patient.
CO2 is injected into the aorta at the level of the celiac access. Now you see the extra vascularization from the low polar spleen, then you catheterize celiac access of the veins. You microcatheter in the distal splenic arteries
and inject the contrast. Oops, there's no bleeding. Make you very uncomfortable for embolizations. We always like to see the actual vascularization before place particle or coils. At that time you can inject CO2 and you can see
actual vascularization and make you more comfortable before embolization. You can inject CO2, the selective injection like in here in a patient with the splenic trauma. The celiac injection of CO2 shows the growth, laceration splenic with extra vascularization with the gas.
There's multiple small, little collection. We call this Starry Night by Van Gogh. That means malpighian marginal sinus with stagnation with the CO2 gives multiple globular appearance of the stars called Starry Night.
You can see the early filling of the portal vein because of disruption of the intrasplenic microvascular structures. Now you see the splenic vein. Normally, you shouldn't see splenic vein while following CO2 injections.
This is a case of the liver traumas. Because the liver is a little more anterior the celiac that is coming off of the anterior aspect of the aorta, therefore, CO2 likes to go there because of buoyancy so we take advantage of buoyancy. Now you see the rupture here in this liver
with following the aortic injections then you inject contrast in the celiac axis to get road map so you can travel through this torus anatomy for embolizations for the road map for with contrast. This patient with elaston loss
with ruptured venal arteries, massive bleeding from many renal rupture with retro peritoneal bleeding with CO2 and aortic injection and then you inject contrast into renal artery and coil embolization but I think the stent is very dangerous in a patient with elaston loss.
We want to really separate the renal artery. Then you're basically at the mercy of the bleeding. So we like a very soft coil but basically coil the entire renal arteries. That was done. - Thank you very much.
- Time is over already? - Yeah. - Oh, OK. Let's finish up. Arteriogram and we inject CO2 contrast twice. Here's the final conclusions.
CO2 is a valuable imaging modality for abdominal and pelvic trauma. Start with CO2 aortography, if indicated. Repeat injections at multiple levels below diaphragm and selective injection road map with contrast. The last advice fo
t air contamination during the CO2 angiograms. Thank you.
- Thank you very much Mr. Chairman. Thank you very much Dr. Veith and Jackie and her team. Aortic thrombus is not the same as endograft thrombus. So I will talk about them separately. And these aortic conditions are rarely causing embolic events, while aortic mural thrombus may cause macro-embolization
and shaggy aorta often cause micro-embolization. And this is the topic of this talk. So aortic mural thrombus develops in the absence of pre-existing aortic disease and can be nonpedunculated versus sessile. It is uncommon with an incidence of 0.45%
in this great autopsy registry, however, leading in 17% of cases to embolization. Therefore, it must be considered in the differential diagnosis of embolic events. In 50% of the patients with aortic mural thrombus, there is a coagulation disorder present.
So imaging of the complete aorta and a hyper-coagulability workup should be done in every patient with aortic mural thrombus. Thrombus in female patients and in younger patients have a higher risk of embolization just as mobile thrombus and thrombus at noncalcified insertion sites.
In symptomatic thrombus in the aorta, you have to treat the emboli first and subsequently the aorta. And this is the largest series comparing anticoagulation along with open aortic surgery, favoring aortic surgery, because of a lower recurrence and lower embolization
rates than anticoagulation alone. However, in a more recent paper TEVAR demonstrated a 93% of thrombus regression, resolution or exclusion, while there was persistent thrombus in 31% of open surgery and medical treatments patients leading for patients to crossover to TEVAR.
So TEVAR or EVAR performs best. And this may lead to suggesting that primary interventional treatments could be considered even for asymptomatic mural thrombus. However, anticoagulation should be reserved for high-risk patients or difficult thrombus locations.
This is a CT scan we have all seen in our practice, in the follow-up of an infrarenal EVAR. Because mural thrombus in endograft is common and mostly develops in the first year post EVAR. - [Man] I don't know, maybe. - It is not associated with age, smoking, malignancy,
anticoagulation or antiplatelet therapy, but may be with coagulation disorders. However, endograft thrombus is associated with a short and wide infrarenal neck and with preoperative thrombus loads. Moreover from a graft perspective,
polyester-coated devices are associated with a higher incidence of endograft from thrombus in analogy with open surgery. This may also be the cause because of hemodynamic properties of these polyester-coated devices, which are usually longer body length,
with smaller limb diameters. This is also the reason why the AUIs are associated with endograft thrombus and a barrel-like configuration of a main body and finally a bell-bottom configuration. So risk factors are aneurysm-related, graft related, and possibly coagulation disorders.
Is mural thrombus associated with thrombo-embolic complications in an endograft? The answer is no, according to these five papers and a recent systematic review. So endograft thrombus rarely leads to thromboembolic complications.
However, thrombus lining in the main body may be less harmful than in the iliac limb. If asymptomatic, consider follow-up. - [Man] With heparin because. - However if limb kinking stenosis or outflow limitations are present, then treatment is advised to prevent occlusion.
And if there is claudication symptomatically then anticoagulation or endograft relining may be considered. This patient presented with an ischemic limb, an ischemic left limb, two years after his EVAR. And you will appreciate on the CT a whole lot
of thrombus in the left stent graft. He was, this thrombus was lodged into the popliteal artery and he was therefore treated with thrombectomy. And in the second stage with relining of the left limb. So if symptomatic and thromboembolic events,
then endograft relining is advised. And if relining, then consider to reline with a less thrombogenic device at BTFE (mumbles). Thank you very much for your attention.
- Thank you for the invitation to discuss suprarenal bare stent fixation. Here are my disclosure. Aneurismal over graft extension is a part of the natural evolution and the natural history of this degenerative disease, and it could be extended to the celiac aorta
and the common iliac, as well. Regarding the extension to the celiac aorta, we have to consider the infrarenal aorta status, when we want to correct that, and mainly the lengths in between renal artery and the bifurcation of the previously implanted graft,
but also the quality of the access route from below. Most importantly is juxtarenal status, with or without bare stent, and we have nine cases of each. The way to correct this kind of failure is the use of chimney,
when fenistrated graft are not usable. And, the secondary chimney celiac extension, we have 18 cases, when there is a long aortic segment longer than 50 mm, we use a combination of a non-bare stent cuff, associated with balloon-expandable covered parallel stents.
And, when there is a short aortic segment, less than 50 mm, or a difficult access, we use an EVAS device, associated, the same way, with balloon-expandable parallel stents. When the juxtarenal aorta is free of bare stent, it's quite easy to place a wire and stents,
and there is no major contrast in between the different components of the chimney, whatever it is, a cuff extension or the use of an EVAS. It's quite different to when there is, when we have to perform a renal stenting over a bare stent, and you can see that we have to develop tricks
to stabilize a wire into the renal stent by aortic balloon, or by a renal balloon, or renal filter, but this kind of tricks are not working very well. And, we had, in some cases, the need for using push-up procedures, which means that we are exerting forces
onto the delivery system and there's a parallel stent, and that lead to compression in between the different components of this chimney. And, in addition, when there is a bare stent previously implanted, there are forces and there is room
for gutter and that's the way to get type 1 Endoleak. And, it's more difficult when the bare stent is creating a stenosis on the ostium of the renal artery, and we had here to place a stent, a bare stent, for angioplasties and to go to a push-up procedures, before implanting the endoaortic graft
and you can see that there is a lot of contrast, onto this renal stent. When there is a bare stent, there is a slight, the operating time is longer, and one type A Endoleak
more in the bare-stent population of patient but we have one occlusion stent on the non-bare stent group. Endoleak could be treated by embolization into the gutter. But, as we want to avoid this kind of difficult procedures, we use a classification,
based on the evolution profile of the aneurysm. When the neck are safe, we use EVAS to prevent type 2 Endoleak. When the neck is cylindrical, but slightly disease, we use a bifurcated graft, with infrarenal fixation. When the neck is short or when there is no neck,
we use four fenestrated graft, or tri-chimney procedures, and when there is a celiac aneurysm, we use thoracoabdominal reconstruction, using a thoracic segment, in addition with four-fenestrated graft, or a thoracic branch device.
Then, to conclude, the bare stent doesn't prevent the evolution of the aneurysmal disease, that means that we have to reconsider the use of endoaortic graft, with bare stent suprarenal fixation, just to anticipate what could happen during the evolution and the ability to perform
a secondary device extension. And thank you for your attention.
- Why Registries can be better than RCT's for evaluating vascular devices. While in time past, an alert physician would make advances using his power of observation, his five senses, and his clinical judgment, but these times are over and we live in the era
of evidence-based medicine. Gave rise to guidelines medicine and cookbook recommendations, and EBM promotes the systematic use of RCTs. However, I would draw your attention and find that if you look at the
history of interventional cardiology, you would find that the first catheterization of the arteries to heart was done in 1929 by a resident, and this was rejected until
Andreas Grunzig decided to make an attempt of opening chronically narrowed coronary arteries using balloons and catheters in '77, and, soon after, cardiologists began blowing balloons to open up thrombosed arteries,
the biggest leap forward in the treatment of cardiovascular disease was born. And there was no randomized trial then. The development of EVAR followed the same path. First EVAR case by Ukraninan Nicholas Volodos in the '80s, but in the western world it starts in '90 by
Juan Parodi followed by a publication of small studio of five case in the Annals of Vascular Surgery in '91. And the first RCTs was published 14 years later. So, if you are speaking of innovation, new device, they are made possible by
inspiration, learning, adaptation, and RCTs, but later on. And despite four RCTs on EVAR by example, there are some uncertainties regarding the effectiveness of EVAR in the long term.
But new stent grafts have been developed, they are promoted to be more durable, but how can we prove this expectation? New RCTs? Results may not be applicable to all patients, because of selection criteria.
The time needed to recruit a patient? As EVAR technology improve, could be obsolete before the study publication. And industry-sponsored RCTs are to be taken with caution, knowing that most negative trials are never published.
But a more realistic way to obtain this information is a large registry with an analysis by propensity score methods. These are based on large cohorts representing the real practice. They can be carried out quickly.
They are cost effective. And for EVAR, MEDICARE registries showed similar results to RCTs. We have to use propensity score to take care of device heterogeneity, patient heterogeneity, provider heterogeneity.
This is very important. And we have to have core data for these registries. We have to use existing registries, industry case report forms. We have to deal with the UD, the unique device identifier. The SVS, SIR registries and the electronic health records.
To example: active surveillance of device. This has been done for the Mynx vascular-closure device. You see, it's a propensity-matched analysis from the CathPCI Registry. In three years, 73,000 patients were followed. Each of these patients had 300 data.
This could not be obtained by randomized controlled trial. And as you see here, you have circles showing the the cumulative incidence of a safety problem, and you see that after less than one year, there was a
significant difference with the current device. So a strategy of surveillance is really valuable in this with a registry. Rapid pathway for label extensions has been also used for transcatheter valve therapy with a registry.
And this data, on 27,000 patients allowed to promote rapid change
and label extension for this device without a new randomized controlled trial. So in conclusion, I think that large, prospective, post-market registries are a safer bet than RCTs
to compare evolving vascular device even if RCTs will stay and remain necessary in many situations. 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, 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 Tim, Manny, Dr. Veith. Again thank you for the kind invitation. Um, here are my disclosures. The Chimney Snorkel Sandwich technique is really one that's been used and discussed many times throughout this great meeting in years past.
I've been asked to kind of see how we expand the use for thoracoabdominal aneurysms. Um, basically it's a matter of putting a parallel graft and then having an inner graft that will help seal the aneurysm sac itself by maintaining
perfusion to the visceral vessels. Um, the number of parallel grafts has been shown to be of note, and generally if you get beyond two parallel grafts at any one location, that tends to dramatically increase the incidence of
gutter leaks and potential for continued perfusion of the aneurysm sac. Here again showing at two, they still keep a reasonable aortic diameter, but once you start going three and four parallel grafts you tend to have significant compression
of the main aortic graft itself, as well as the potential for gutter leaks. Um, the PERICLES Registry certainly looked as I know has been discussed earlier in this meeting, and basically what it showed was that this was a reasonable way of treating
some of these complex aneurysms with a durable outcome going out to two to three years, uh, at a survival rate of over 70 percent. So, to show how we use this for patients with thoracoabdominal aneurysms, this was a 67 year, I use the term is,
a 67-year-old gentleman presented urgently with a sudden onset of back and abdominal pain. Apparently he was, uh, had a new wife and was trying some sexually enhancing medications from the DR. Had a history of coronary artery disease,
erectile dysfunction, and congestive heart failure, and CT scan revealed a type four thoracoabdominal dissection with a eight centimeter juxtarenal aneurysm, and he was in acute pain. Uh, here is the CT scan as we go through,
and you can see obviously the very complex dissection. You had a small segment of perfusion still around the level of the celiac going down into the SMA, uh, and then this rather, again the renals were
also with a small luminal area, and then a large aneurysm going up to eight centimeters going down into the abdominal component, and then reasonable access vessels from below. This shows the dissection extending down
through the thoracoabdominal segment, and again, he was in acute pain. Uh, so we came in and did an angiogram and IVUS, uh, and here we show the area of the dissection going down as well as the take-off of the subclavian artery.
Again, the true lumen being here. This was confirmed with IVUS. The IVUS sash, and this is the true lumen here, the false lumen being around the periphery, and as you go through you can see there's almost complete collapse of that
true lumen throughout the cardiac cycle. Uh, we performed a left carotid subclavian bypass, and embolized the left subclavian artery and put a thoracic endograft in, covering that lead point as you go in and taking it really almost up to the level of the left carotid artery.
There you can see the occluded subclavian. Uh, with that in place we then prepared to do a four vessel sandwich, or double sandwich, technique. Here we came down, we brought the grafts down to about the level of the takeoff of the celiac access with thoracic endografts.
Lateral shows the takeoff of the celiac and the SMA. Uh, we were able to catheterize both those vessels from the axillary region and put stents going out in this two sandwich technique, uh, and then actually put our stents going out from both the celiac and SMA.
We then were able to do that once we had those stents in place with adequate overlap and no real gutter leak, we then came down and similarly put another graft down to the takeoff of the renal vessels and then selectively catheterized
the right and left renal. Here you can see the stenosis near the origin of the right renal artery. With that we then performed balloon angioplasty with covered stents, I believe these were VBX stents going out,
and then covered that further down as we went down into the area of the eight centimeter aneurysm. And here we come in building down from that area and the perivisceral segment down and then to the iliacs showing good perfusion down to the takeoff of the
hypogastric, and then finally angiogram showed we had good perfusion to celiac, SMA, both renal vessels, and then down through the aneurysm sac itself. This is, uh, he remains stable. His postoperative course actually was uneventful.
He was discharged from the hospital at day four. He's been seen back now at one year follow up at six and 12 month follow up and he's remained stable with no evidence of endo-leak. So I appreciate the opportunity to try and present a more novel way of managing
these patients in the acute setting. Thank you very much.
- That's a long title, thank you. We shortened the title, and just said, The Iliac Artery's Complicating Complex Juxtarenal and Thoracal Abdominal Repair. I have no disclosures. So, Iliac artery preservation is important whenever we start doing complex aortic aneurysm repair.
We don't understand completely what the incidence is with these extensive aneurysms. We know with AAAs, anywhere in the 10 to 40% have some sort of iliac artery involvement. It certainly can complicate the management as we get to these more complicated repairs.
Iliac artery preservation may be important for prevention of spinal cord ischemia, and those people in whom we can maintain both hypogastric arteries, it occurs at a less significant rate, with less severe symptoms and higher rates of recovery.
The aim of our study was to evaluate the incidence, management, and outcomes of iliac artery aneurysms associated with complex aortic aneurysms treated with fenestrated and branched endografts. Part of a PS-IDE study over a 15 year period of time,
this is dated from the Cleveland Clinic for the treatment of juxtarenal aneurysms and thoracal abdominal aortic aneurysms. For the purpose of this study, we defined an iliac artery aneurysm is 21 mm or greater as determined by diameter
by our core lab. We chose 21 mm because this was outside of the IFU for the iliac wounds that we had currently available to us at that time. We did multivariable analysis on the number of different outcomes. And we looked at the incidence
of iliac artery aneurysms by repair type. In all the aneurysms we treated, we see about a third of the patients had some level of iliac artery aneurysm involvement. In those patients that had less extensive thoracal abdominals, the type three
and type four abdominals, it occurred in about a third of the cases. A little bit less than the type two and the type one thoracal abdominals. We look at the demographics between those that had iliac artery aneurysm
involvement and those that did not have iliac artery involvement. It was more common in males to have iliac artery involvement than any other group. There are more females that didn't have iliac artery aneurysms. The rest
of the demographics were the same between the two groups. We look at the anatomic characteristics of the iliac artery aneurysms, about 60% of them were unilateral, about 40% of them were bilateral.
The mean iliac artery aneurysm size was 28 mm and that was the same on both sides. And we look at thought the percent that were actually very large, or considered large enough to potentially in and of themselves the repairs
greater than three centimeters. About 28% of them were greater than three centimeters on each side. If we look at our iliac artery aneurysm treatment type, this is 509 iliac artery aneurysms that
were treated out of all these patients. About 46% of them, we were able to obtain a seal distal to the iliac artery aneurysm. So it really only involved the proximal portion, the proximal half of the iliac artery.
20% of them, we placed a hypogastric branched endograft, and about 20% of them, we placed a hypogastric coverage plus embolization of that internal iliac artery. About 13% of them were left untreated at the time for a variety of different operative reasons.
Why is there a difference between the hypogastric coverage and embolization? It was availability of devices and surgeon choice at the time. At one point, we had a opportunity to be able to treat both fairly easily
on both sides and at one point we did not. Larger iliac artery aneurysms were treated with hypogastric coverage or hypogastric branched endografts, and there was a significant difference between the two. Most of the mean
size of those that were actually treated with either hypogastric branch or embolization for greater than three centimeters. If we look at peri-operative outcomes in those without iliac artery aneurysms versus those with iliac artery aneurysms.
We see that the fluoroscopy estimated blood loss is larger for those with iliac artery aneurysms, fluoroscopy time was longer and procedure duration was a bit longer as well. Obviously, a bit more complicated procedure,
more steps that's going to take a little bit longer to perform them. It did not effect the length of stay for these patients or the length of stay in the intensive care unit following the procedures. We look
at all-cause mortality at five years, no difference in whether they had an iliac artery aneurysm or not. It didn't matter whether it was unilateral or bilateral. If we look at aneurysm-related mortality, it's the same whether
they had the iliac artery aneurysm or not. Same for unilateral versus bilateral as well. Where we start to see some differences are the freedom from reintervention. This did vary between, among the three groups. In those patients without an iliac
artery aneurysm, they had the lower reintervention rate than those with the unilateral iliac artery aneurysm, and even lower rates from freedom from reintervention in those that had bilateral iliac artery aneurysms. Spinal cord ischemia, one of the
reasons we try to preserve both the hypogastric arteries. Look at our total spinal cord ischemia incidents. It didn't vary between the two groups, but if we look specifically, the type two thoracal abdominal aortic aneurysms in those patients that had bilateral
iliac arte higher rate of spinal cord ischemia compared to those that did not have any iliac artery aneurysms or those that had an internal iliac, a single iliac artery aneurysm.
So, iliac artery aneurysms affect about a third of the patients with complex aortic disease. They do not, their presence does not affect all-cause mortality or aneurysm related mortality. They are associated with a higher reintervention rate.
In extensive aneurysms, may be higher association with higher spinal cord ischemia rates. We need additional efforts are needed to improve outcomes and understanding appropriate application of different treatment options for patients with
complex aortic disease. Thank you.
- Thank you. Historically, common femoral endarterectomy is a safe procedure. In this quick publication that we did several years ago, showed a 1.5% 30 day mortality rate. Morbidity included 6.3% superficial surgical site infection.
Other major morbidity was pretty low. High-risk patients we identified as those that were functionally dependent, dyspnea, obesity, steroid use, and diabetes. A study from Massachusetts General Hospital their experience showed 100% technical success.
Length of stay was three days. Primary patency of five years at 91% and assisted primary patency at five years 100%. Very little perioperative morbidity and mortality. As you know, open treatment has been the standard of care
over time the goal standard for a common femoral disease, traditionally it's been thought of as a no stent zone. However, there are increased interventions of the common femoral and deep femoral arteries. This is a picture that shows inflection point there.
Why people are concerned about placing stents there. Here's a picture of atherectomy. Irritational atherectomy, the common femoral artery. Here's another image example of a rotational atherectomy, of the common femoral artery.
And here's an image of a stent there, going across the stent there. This is a case I had of potential option for stenting the common femoral artery large (mumbles) of the hematoma from the cardiologist. It was easily fixed
with a 2.5 length BioBond. Which I thought would have very little deformability. (mumbles) was so short in the area there. This is another example of a complete blow out of the common femoral artery. Something that was much better
treated with a stent that I thought over here. What's the data on the stenting of the endovascular of the common femoral arteries interventions? So, there mostly small single centers. What is the retrospective view of 40 cases?
That shows a restenosis rate of 19.5% at 12 months. Revascularization 14.1 % at 12 months. Another one by Dr. Mehta shows restenosis was observed in 20% of the patients and 10% underwent open revision. A case from Dr. Calligaro using cover stents
shows very good primary patency. We sought to use Vascular Quality Initiative to look at endovascular intervention of the common femoral artery. As you can see here, we've identified a thousand patients that have common femoral interventions, with or without,
deep femoral artery interventions. Indications were mostly for claudication. Interventions include three-quarters having angioplasty, 35% having a stent, and 20% almost having atherectomy. Overall technical success was high, a 91%.
Thirty day mortality was exactly the same as in this clip data for open repair 1.6%. Complications were mostly access site hematoma with a low amount distal embolization had previously reported. Single center was up to 4%.
Overall, our freedom for patency or loss or death was 83% at one year. Predicted mostly by tissue loss and case urgency. Re-intervention free survival was 85% at one year, which does notably include stent as independent risk factor for this.
Amputation free survival was 93% at one year, which factors here, but also stent was predictive of amputation. Overall, we concluded that patency is lower than historical common femoral interventions. Mortality was pretty much exactly the same
that has been reported previously. And long term analysis is needed to access durability. There's also a study from France looking at randomizing stenting versus open repair of the common femoral artery. And who needs to get through it quickly?
More or less it showed no difference in outcomes. No different in AVIs. Higher morbidity in the open group most (mumbles) superficial surgical wound infections and (mumbles). The one thing that has hit in the text of the article
a group of mostly (mumbles) was one patient had a major amputation despite having a patent common femoral artery stent. There's no real follow up this, no details of this, I would just caution of both this and VQI paper showing increased risk amputation with stenting.
- Good morning, thank you, Dr. Veith, for the invitation. My disclosures. So, renal artery anomalies, fairly rare. Renal ectopia and fusion, leading to horseshoe kidneys or pelvic kidneys, are fairly rare, in less than one percent of the population. Renal transplants, that is patients with existing
renal transplants who develop aneurysms, clearly these are patients who are 10 to 20 or more years beyond their initial transplantation, or maybe an increasing number of patients that are developing aneurysms and are treated. All of these involve a renal artery origin that is
near the aortic bifurcation or into the iliac arteries, making potential repair options limited. So this is a personal, clinical series, over an eight year span, when I was at the University of South Florida & Tampa, that's 18 patients, nine renal transplants, six congenital
pelvic kidneys, three horseshoe kidneys, with varied aorto-iliac aneurysmal pathologies, it leaves half of these patients have iliac artery pathologies on top of their aortic aneurysms, or in place of the making repair options fairly difficult. Over half of the patients had renal insufficiency
and renal protective maneuvers were used in all patients in this trial with those measures listed on the slide. All of these were elective cases, all were technically successful, with a fair amount of followup afterward. The reconstruction priorities or goals of the operation are to maintain blood flow to that atypical kidney,
except in circumstances where there were multiple renal arteries, and then a small accessory renal artery would be covered with a potential endovascular solution, and to exclude the aneurysms with adequate fixation lengths. So, in this experience, we were able, I was able to treat eight of the 18 patients with a fairly straightforward
endovascular solution, aorto-biiliac or aorto-aortic endografts. There were four patients all requiring open reconstructions without any obvious endovascular or hybrid options, but I'd like to focus on these hybrid options, several of these, an endohybrid approach using aorto-iliac
endografts, cross femoral bypass in some form of iliac embolization with an attempt to try to maintain flow to hypogastric arteries and maintain antegrade flow into that pelvic atypical renal artery, and a open hybrid approach where a renal artery can be transposed, and endografting a solution can be utilized.
The overall outcomes, fairly poor survival of these patients with a 50% survival at approximately two years, but there were no aortic related mortalities, all the renal artery reconstructions were patented last followup by Duplex or CT imaging. No aneurysms ruptures or aortic reinterventions or open
conversions were needed. So, focus specifically in a treatment algorithm, here in this complex group of patients, I think if the atypical renal artery comes off distal aorta, you have several treatment options. Most of these are going to be open, but if it is a small
accessory with multiple renal arteries, such as in certain cases of horseshoe kidneys, you may be able to get away with an endovascular approach with coverage of those small accessory arteries, an open hybrid approach which we utilized in a single case in the series with open transposition through a limited
incision from the distal aorta down to the distal iliac, and then actually a fenestrated endovascular repair of his complex aneurysm. Finally, an open approach, where direct aorto-ilio-femoral reconstruction with a bypass and reimplantation of that renal artery was done,
but in the patients with atypical renals off the iliac segment, I think you utilizing these endohybrid options can come up with some creative solutions, and utilize, if there is some common iliac occlusive disease or aneurysmal disease, you can maintain antegrade flow into these renal arteries from the pelvis
and utilize cross femoral bypass and contralateral occlusions. So, good options with AUIs, with an endohybrid approach in these difficult patients. Thank you.
- I'd like to thank Dr. Veith for this kind invitation and the committee as well. So these are my disclosures, there's none. So for a quick background regarding closure devices. Vascular closure devices have been around
for almost 20 years, various types. Manual compression in most studies have always been shown to be superior to vascular closure devices mainly because there's been no ideal device that's been innovated to be able
to handle all sorts of anatomies, which include calcified vessels, soft plaque, etc. So in this particular talk we wanted to look at to two particular devices. One is the Vascade vascular closure device
made by Cardiva and the other is the CELT arterial closure device made by Vasorum in Ireland. Both these devices are somewhat similar in that they both use a disc. The Vascade has a nitinol disc
as you can see here that's used out here to adhere to the interior common femoral artery wall. And then once tension is applied, a series of steps is involved to deploy the collagen plug
directly on to the artery which then allows it to expand over a period of time. The CELT is similar in that it also uses a stainless steel disc as you can see here. Requires tension up against the interior wall of the common femoral artery.
Nice and tight and then you screw on the top end of the device on to the interior wall of the artery creating a nice little cylinder that compresses both walls of artery. As far as comparability is concerned between the two devices you can see
here that they're both extravascular, one's nitinol, one's stainless steel. One uses a collagen material, the other uses an external clip in a spindle-type fashion. Both require about, anywhere between three to seven minutes of pressure
to essentially stop the tract ooze. But the key differences between the two devices, is the amount of time it takes for patients to ambulate. So the ambulation time is two hours roughly for Vascade, whereas for a CELT device
it's anywhere from being immediate off the table at the cath lab room to about 20 minutes. The data for Vascade was essentially showing the RESPECT trial which I'll summarize here, With 420 patients that was a randomized trial
to other manual compression or the device itself. The mean points of this is that the hemostasis time was about three minutes versus 21 minutes for manual compression. And time to ambulation was about 3.2 hours versus 5.7 hours.
No major complications were encountered. There were 1.1% of minor complications in the Vascade versus 7% in the manual compression arm. This was actually the first trial that showed that a actual closure devices
had better results than manual compression. The main limitations in the trial didn't involved complex femoral anatomy and renal insufficiency patients which were excluded. The CELT ACD trial involved 207 patients that were randomized to CELT or to manual
compression at five centers. Time to hemostasis was anywhere between zero minutes on average versus eight minutes in the manual compression arm. There was one complication assessed at 30 days and that was a distal embolization that occurred
early on after the deployment with a successfully retrieved percutaneously with a snare. So complication rate in this particular trial was 0.7% versus 0% for manual compression. So what are some pros and cons with the Vascade device?
Well you can see the list of pros there. The thing to keep in mind is that it is extravascular, it is absorbable, it's safe, low pain tolerance with this and the restick is definitely possible. As far as the cons are involved.
The conventional bedrest time is anywhere between two to three hours. It is a passive closure device and it can create some scarring when surgical exploration is necessary on surgical dissections.
The key thing also is you can not visualize the plug after deployment. The pros and cons of the CELT ACD device. You can see is the key is the instant definitive closure that's achieved with this particular device, especially in
calcified arteries as well. Very easy to visualize under fluoroscopy and ultrasound. It can be used in both antegrade and retrograde approaches. The key cons are that it's a permanent implant.
So it's like a star closed devised, little piece of stainless steel that sits behind. There's a small learning curve with the device. And of course there's a little bit of discomfort associated with the cinching under the (mumbles) tissue.
So we looked at our own experience with both devices at the Christie Clinic. We looked at Vascade with approximately 300 consecutive patients and we assessed their time to hemostasis, their time to ambulation,
and their time to discharge, as well as the device success and minor and major complications. And the key things to go over here is that the time to hemostasis was about 4.7 minutes for Vascade, at 2.1 hours for ambulation, and roughly an average
of 2.4 hours for discharge. The device success was 99.3% with a minor complication rate of .02% which we have four hematomas and two device failures requiring manual compression. The CELT ACD device we also similarly did
a non-randomized perspective single center trial assessing the same factors and assessing the patients at seven days. We had 400 consecutive patients enrolled. And you can see we did 232 retrograde. We did a little bit something different
with this one, we did we 168 antegrade but we also did direct punctures to the SFA both at the proximal and the mid-segments of the SFA. And the time to hemostasis in this particular situation was 3.8 minutes,
ambulation was 18.3 minutes, and discharge was at 38.4 minutes. We did have two minor complications. One of which was a mal-deployment of the device requiring manual compression. And the second one was a major complication
which was an embolization of the device immediately after deployment which was done successfully snared through an eighth front sheath. So in conclusion both devices are safe and effective and used for both
antegrade and retrograde access. They're definitely comparable when it comes, from the standpoint of both devices (mumbles) manual compression and they're definitely really cost effective in that they definitely do increase the
throughput in the cath lab allowing us to be able to move patients through our cath lab in a relatively quick fashion. Thank you for your attention.
- [Dr. Lobato] Thank you. I have no disclosure. To give you some tips about Sandwich Technique. Of course, the first step is to have a proximal neck. We need to have at least 15 millimeter in length and no bigger than 40 millimeter in diameter, and your stent graft should finish
at one or two centimeters above the celiac trunk to avoid using longer self-expandable covered stent. That's why we needed to finish as close as possible to the celiac trunk. When you're talking about Type 1, Type 2, or Type 3 thoracoabdominal aneurysm
we need to revascularize all four visceral arteries, so our option is to come from above from the left axillary artery or the right brachial artery. Three cannulations. You cannulate the celiac trunk,
you cannulate the SMA, and one renal artery. Then we apply the bifurcated stent graft in front, contralaterally I cannulate the left or right renal, it depends on the best way to cannulate that. In this moment,
you already have your long introducer inside of the visceral arteries and also now from the femoral one another introducer and the self-expandable covered stent. That's my option,
self-expandable covered stent because it's longer. So if you use a bare metal covered stent, it means you need two or more stent graft for that. I keep the self-expandable, the sacs inside of the visceral artery
and use the bridge thoracic stent graft now. These thoracic stent graft must have 30% oversizing. The key point, that you need to create the five centimeters overlapping between the two thoracic stent grafts in the middle, from above the three sacs,
and from below the renal sacs also. You need to have 5 centimeters for that. Then the point is to apply the stent graft, the thoracic stent graft, you use a latex balloon to accommodate it. These stent grafts in between the sacs of that.
This is very important. Do not deploy that moment the self-expandable covered stent. After I use the latex balloon, so in this moment, we deploy the self-expandable covered stent now
inside the visceral arteries. It's not mandatory anymore to use a self-expandable covered stent. Bare metal one as well, the angioplasty for that. Then you deploy the contralateral limb.
Just to show how it looks like, the Sandwich Technique, you see now the 42 millimeter stent graft, and the 8 millimeter self-expandable covered stent in the visceral arteries and one 6 millimeter in the renal artery.
How it looks, the lumen, for that Sandwich. It's very important for that. For this case, this aorta, the healthy aorta has 22 millimeter, so it's impossible. That's a precaution.
It's impossible to do a Sandwich in this case because you have no lumen. Let's remind, we've used three stent graft, two covered stent inside that. So you must precaution about the lumen.
The other point, I avoid now to use bare metal self-expandable stent. I have fracture when I use the self-expandable covered stent inside that bare metal self-expandable stent. I got a fracture in the part inside the renal artery.
Not together with the covered stent, but outside the covered stent. If you needed to do that, you need to choose inside of the covered stent. In the other point, you need to avoid a cross over
between the self expandable covered stent to the other one. So that's another key that you can use with your introducer and make sure that you do not make this movement. The other point, I do not like as much the bare metal stent, I got some fracture in the renal arteries.
As you can see here, preimposed post-operative area. It's a six month post-operative fracture. Another point is you need to deploy your covered stent at least two centimeters inside of the visceral artery. This one was less than two centimeters,
so in the post-operative six month you've got a migration in the Type 2 endoleak here, as you can see. So you must prepare to use that. Another precaution is about subclavial occlusion, extra-anatomic bypass,
no LIMA bypass, unilateral or bilateral hypogastric artery occlusion, shaggy aorta, and concomitant aortic arch aneurysm. In conclusion, ladies and gentlemen, the Sandwich Technique facilitates safe
and effective thoracoabdominal exclusion, and some precautions must be taken to sustain the durability in midterm follow-up. Thank you very much.
- The committee asked me to give an update on the Cook p-Branch device which is in a clinical trial in the United States. This is the disclosures as it relates to this talk. I'm going to discuss the feasibility as well as the pivotal study as you see on this slide. Now these two studies, as you can imagine,
have a different number of patients. The feasibility study was done in 30 patients and, as all studies in the U.S., required a five-year follow-up. And the p-Branch pivotal study is involving 82 patients with also a five-year follow-up, with the objectives really to assess the device's
safety and effectiveness and primary endpoints, treatment at one year. Now, the feasibility study enrolled 30 patients at 10 U.S. sites over a two and a half year period, roughly. So here the mean age was 73 years and maximum aneurysm diameter's 65 millimeters
and proximal neck length with the enrolled patients was 21 millimeters. The distribution of A configuration where the two renal pivot fenestration's are at the same level is 57% and the B configuration which is an offset was 43% of the patients.
About 226 mean operative time, slightly more or close to 70 minutes of fluoro time and about one day in the ICU, and three, four days in the hospital. There were two technical problems, the first two patients enrolled at the same site for the trial,
had the p-Branch deployed below the renal arteries due to difficulty with the cannulation and the case done the following day also had a technical failure by not being able to get in a renal. This prompted an update and some physician training and proctoring so that we actually sent proctors to sites,
and the next 28 cases were all successful. Overall, in the feasibility study, 30 day mortality is 0%. Three deaths in the late phase, after 30 days from a cerebral aneurysm. Dissection at slightly less than a year of a proximal
thoracic aneurysm and cardiomyopathy. Freedom from all-cause mortality was 93% in one year, and 89% at 2 years. No ruptures or surgical conversion to date as of last year, when we locked the data. 28 mean follow-up.
Now, if you look at the renal artery patency, which is what all of us are looking at for these types of studies, you see primary patency of stinted renal arteries for this study is on the left. And if you compare that to the initial p-Branch, a single study that was published last year, very similar.
As well as the ZFEN multicenter trial, you see the patencies are quite similar. What about secondary interventions? If you look at this table, we've plotted out secondary interventions at 30 days, and overall, you see the p-Branch feasibility study
slightly higher, but not statistically significant between that and the p-Branch single-center. And the ZFEN is quite low with the 1%. Overall, the secondary interventions were about a third of the patients in most of these studies. Well, what about the pivotal studies?
They said this is an ongoing trial, it's been going on for about three years, we've had about three quarters of the patients enrolled after three years, and we have 28 active sites. We have data on the first 51 patients enrolled, and you see the high enrollers there on the far right.
The mean age is very similar to the feasibility study. 71 years of age, most patients are male, slightly over six centimeters for the diameter, and approximately one millimeter longer at 22 versus 21. The distribution of A and B is also quite similar, as you see here, slightly more A than B,
anywhere from the 55 to 60% range for most all of these studies. Procedures time with the 28 cites now is very similar, 258 minutes, slightly less than the prior study. And you see the fluro time and days in the ICU and discharge very similar.
At 30 days in those 51 patients, no deaths, no renal or bowel ischemia, no neurologic complications or rupture. There had been 3 occlusions of fenestrated vessels, left and renal artery occlusion at day 23, 23, and 30, so these are most likely technical issues
that the stint is crushed. And we've look at that and we'll continue to monitor that. Two patients had re-intervention subsequently, and no patients developed renal insufficiency renal failure at the time of this analysis. So, overall, patient selection, physican technical
abilities, and proper device training will continue to be important for p-Branch implementation and implantation. The feasibility study, early and intermediate results support its safety and feasibility of off-the-shelf device. Follow-up through five years is ongoing. Enrolled is going to continue for the pivotal study
and currently we need less than 20 cases to complete. Thank you.
- Thank you, good morning everybody. Thank you for the kind invitation, Professor Veith, it's an honor for me to be here again this year in New York. I will concentrate my talk about the technical issues and the experience in the data we have already published about the MISACE in more than 50 patients.
So I have no disclosure regarded to this topic. As you already heard, the MISACE means the occlusion of the main stem of several segmental arteries to preserve the capability of the collateral network to build new arteries. And as a result, we developed
the ischemic preconditioning of the spinal cord. Why is this so useful? Because it's an entirely endovascular first stage of a staged approach to treat thoracoabdominal aortic aneurysm in order to reduce the ischemic spinal cord injury.
How do you perform the MISACE? Basically, we perform the procedure in local anesthesia, through a percutaneous trans-femoral access using a small-bore sheath. The patient is awake, that means has no cerebrospinal fluid damage
so we can monitor the patient's neurological for at least 48 hours after the procedure. So, after the puncture of the common femoral artery, using a technique of "tower of power" in order to cannulate the segmental arteries. As you can see here, we started with a guiding catheter,
then we place a diagnosis catheter and inside, a microcatheter that is placed inside the segmental artery. Then we started occlusion of the ostial segment of the segmental artery. We use coils or vascular plugs.
We don't recommend the use of fluids due to the possible distal embolization and the consequences. Since we have started this procedure, we have gained a lot of experience and we have started to ask,
what is a sufficient coilembolization? As you can see here, this artery, we can see densely packed coils inside, but you can see still blood flowing after the coil. So, was it always occluding, or is it spontaneous revascularization?
That, we do not know yet. The question, is it flow reduction enough to have a ischemic precondition of the spinal cord? Another example here, you can see a densely packed coil in the segmental artery at the thoracic level. There are some other published data
with some coils in the segm the question is, which technique should we use, the first one, the second one? Another question, is which kind of coil to use? For the moment, we can only use the standard coils
in our center, but I think if we have 3-D or volume coils or if you have microvascular plugs that are very compatible with the microcatheter, we have a superior packing density, we can achieve a better occlusion of the segmental artery, and we have less procedure time and radiation time,
but we have to think of the cost. We recommend to start embolization of the segmental artery, of course, at the origin of it, and not too far inside. Here, you can see a patient where we have coiled a segmental artery very shortly after the ostium,
but you can see here also the development of the collaterals just shortly before the coils, leading to the perfusion of segmental artery that was above it. As you can see, we still have a lot of open question. Is it every patent segmental artery
a necessary to coil? Should we coil only the large ones? I show you an example here, you can see this segmental artery with a high-grade stenotic twisted ostium due to aortic enlargement.
I can show you this segmental artery, six weeks after coiling of a segmental artery lower, and you can see that the ostium, it's no more stenotic and you can see also the connection between the segmental artery below to the initial segmental artery.
Another question that we have, at which level should we start the MISACE? Here, can see a patient with a post-dissection aneurysm after pedicle technique, so these are all uncovered dissection stent, and you can see very nicely the anterior spinal artery
feeded by the anterior radiculomedullary artery from the segmental artery. So, in this patient, in fact, we start the coiling exactly at the seat of this level, we start to coil the segmental artery that feeds the anterior spinal artery.
So, normally we find this artery of the Th 9 L1, and you can see here we go upwards and downwards. We have some challenges with aneurysm sac enlargement, in this case, we use this technique to open the angle of the catheter, we can use also deflectable steerable sheath
in order to reach the segmental artery. And you can see here our results, again, I just will go fast through those, we have treated 57 patients, most of them were Type II, Type III aortic aneurysms. We have found in median nine patent segmental artery
at the level of the aorta to be treated, between 2 and 26, and we have coiled in multiple sessions with a mean interval of 60 days between the sessions. No sooner than seven days we perform the complete exclusion of the aneurysm
in order to let the collateral to develop, and you can see our result: at 30 days we had no spinal cord ischemia. So I can conclude that our first experience suggest that MISACE is feasible, safe, and effective, but segmental artery coiling in thoracoabdominal aneurysm
can be challenging, it's a new field with many open questions, and I looking forward for the results with PAPA_ARTiS study. Thank you a lot.
- Mr Chairman, dear colleagues. I've nothing to disclose. We know that aneurysm or dilation of the common iliac artery is present in almost 20% of cases submitted to endovascular repair and we have a variety of endovascular solution available. The first one is the internal iliac artery
embolization and coverage which is very technically easy but it's a suboptimal choice due to the higher risk of thrombosis and internal iliac problems. So the flared limbs landing in the common iliac artery is technically easy,
however, the results in the literature are conflicting. Iliac branch devices is a more demanding procedure but has to abide to a specific anatomical conditions and is warranted by good results in the literature such as this work from the group in Perugia who showed a technical success of almost 100%
as you can see, and also good results in other registries. So there are unresolved question about this problem which is the best choice in this matter, flared limbs or iliac branch devices. In order to solve this problem, we have looked at our data,
published them in Journal Vascular Interventional Neurology and this is our retrospective observational study involving treatment with either flared limbs or IBD and these are the flared limbs devices we used in this study. Anaconda, Medtronic, Cook and Gore.
And these are the IFU of the two IBD which were used in this study which were Gore-IBE and Cook-ZBS. So we looked at the 602 EVAR with 105 flared limbs which were also fit for IBD. And on the other side, we looked at EVAR-IBD
implanted in the same period excluding those implanted outside the IFU. So we ended up with 57 cases of IBD inside the IFU. These are the characteristics of the two groups of patients. The main important finding was the year age which was a little younger in the IBD group
and the common iliac artery diameter which was greater, again in the IBD group. So this is the distribution of the four types of flared limbs devices and IBD in the two groups. And as you can see, the procedural time and volume of contrast medium was significantly
higher in the IBD group. Complications did not differ significantly however, overall there were four iliac complication and all occurred in the flared limbs group. When we went to late complications, putting together all the iliac complication, they were significantly
greater in the flared limbs group compared with the IBD with zero percent complication rate. Late complications were always addressed by endovascular relining or relining and urokinase in case of infusion, in case of thrombosis. And as you can see here, the late outcome
did not differ significantly in the two groups. However, when we put together all the iliac complication, the iliac complication free survival was significantly worse in the flared limbs group. So in conclusion, flared limbs and IBD have similar perioperative outcomes.
IBD is more technically demanding, needs more contrast medium and time obviously. The complications in flared limbs are all resolvable by endovascular means and IBD has a better outcome in the long term period. So the take-home message of my presentation
is that we prefer IBD in young patients with high life expectancy and in the presence of anatomical risk factors of flared limbs late complications. Thank you for your attention.
- Thank you very much, Dr. Veith, and thank you to you and the organizing committee for inviting me to participate again this year in, really, the premiere vascular meeting. This morning, I'd like to talk about the contemporary management of carotid artery aneurysms. These are my disclosures.
Extracranial carotid artery aneurysms and pseudoaneurysms may result from a variety of causes, including trauma, fibromuscular dysplasia, atherosclerosis. They're associated with dissection, connective tissue disorders, mycotic aneurysms associated with infection.
We see patch aneurysms from prior carotid endarterectomy, as well as aneurysms associated with radiation, and those that occur spontaneously. Sequelae of these aneurysms are often distal embolization, potential for thrombosis, some patients experience compressive symptoms, and rupture may occur as well.
Treatment has traditionally been through open surgical repair, but there have been advances in endovascular treatments, including covered stents, woven stents, such as the pipeline stent in size-appropriate cases, bare stents with or without adjunctive coil embolization.
Open surgical repair has been time tested and it's proven to be very effective, but there are potential morbidities associated with challenges or surgical exposure, particularly in patients with prior surgery or radiation and those with anatomically-challenging lesions.
A very definitive review of this has been conducted by the surgeons at the Mayo Clinic, including Drs. Money, Bower, and Fowl, and they have described the treatment of 141 aneurysms in 132 patients. In the evolution of treatment with endovascular techniques, covered stents have been employed.
These eliminate aneurysm and pseudoaneurysm perfusion completely and immediately after deployment, but there have been reports of delayed thrombosis of these covered stents when they've been deployed in the cervical distribution. This is a patient of ours who has a large patch aneurysm, nearly four centimeters in size.
If you look on the CAT scan you'll see there's very limited, essentially no overlying soft tissues as a result of the previous radical neck dissection. In this case, we'd elected to use a covered stent to achieve exclusion of this patch aneurysm, and then used a bare metal stent distally to augment the treatment itself.
Our therapies progressed to the use of bare metal stents with associated coil embolization so-called stent, assisted coil embolization. As you can see, there are two sequential, very large, pseudoaneurysms of the internal carotid artery. Here's the carotid bifurcation.
Here, I hope you can see between these green arrows, is the stent that's been deployed. We use closed cell stents typically for these applications, and we can use a microcatheter cannulate that pseudoaneurysm and deploy large neuro-embolic coils to promote flow of cessation.
When we follow up with these patients, here's this patient's one-month post-operative duplex ultrasound, there's no flow in the pseudoaneurysm, and excellent flow in the internal carotid artery without stenosis. We've then progressed to the use of overlapping closed cell stents, and in doing so,
hoped to sort of simulate the pipeline woven stent configuration but have greater applicability in terms of diameter of the internal carotid. Here, you can see this internal carotid artery spontaneous pseudoaneurysm. We then go ahead and bring our initial stent into position
across the origin of the pseudoaneurysm. Here's after initial stent deployment on this static image. Here, after our second stent deployment, you can see very limited static flow within the pseudoaneurysm itself, and that's evidenced by, after the flowed out of the internal carotid artery,
there's still residual contrast within the pseudoanerusym. Here are the individual characteristics of the patients that we've treated using endovascular techniques. To summarize those data, the mean duration of follow up for these patients is 331 days.
But we have followed one patient out to eight years. The study's limited by the relatively small number of patients and the limited duration of follow up in these patients. But our technical success has been 100%, in terms of being able to deploy the endovascular
techniques, and maintain patency. We've had no patients who've experienced neurologic sequelae, including no strokes or TIAs. There've been no cases in which the aneurysm has expanded, in most cases, the aneurysm itself regresses and there's been no flow within those aneurysms or pseudoaneurysms.
Finally, we have been able to maintain 100% patency in these patients, as monitored using our standard follow up protocol with duplex ultrasound being performed every three months for the first year, and annually thereafter. In conclusion, extracranial carotid artery aneurysms and pseudoaneurysms may be treated effectively
using standard open techniques. However, surgical exposure and perioperative morbidity may present challenges for open repair. Endovascular approaches to aneurysm and pseudoaneurysm treatment have evolved progressively. The preliminary results of our analysis with mid-term
follow up suggest that these techniques are effective and durable, with limited procedural morbidity. Thank you very much.
- [Doctor] Thank you Tom and thanks Dr Veith for the invitation to be here again. These are my disclosures, so hypogastric embolization is not benign, patients can develop buttock claudication, higher after bilateral sacrifice, it can be persistent in up to half of patients. Sexual dysfunction can also occur, and we know that
there can be catastrophic complications but fortunately they're relatively rare. So now these are avoidable, we no longer have to coil and cover in many patients and we can preserve internal iliac's with iliac branch devices like you just heard. We had previously published the results of looking from
the pivotal trial, looking at the Gore IBE device with the six month primary end point showing zero aneurysm-related morality, high rates of technical success, 95% patency of the internal iliac limb, no type one or type three endoleaks and 98% freedom from reintervention. Importantly on the side of the iliac branch device, there
was prevention of new-onset of buttock claudication in all patients, and importantly also on the contralateral side in patients with bilateral aneurysms that were sacrificed, the incidents in a prospect of trial of the development of buttock claudication was 28%, confirming the data from those prior series.
And this is in line with the results of EVAR using iliac branch device published by many others showing low rates of mortality, high rates of technical success and also good patency of the devices. In press now we have results with follow-up out through two years, in the Gore IBE trial, we also compared
those findings to outcomes in a real world experience from the great registry, so 98 patients from the pivotal and continued access arm's of the IBE trial and also 92 patients who underwent treatment with the Gore IBE device in the great registry giving us 190 patients with 207 IBE devices implanted.
Follow-up was up to three years, it was an longer mean follow-up in the IDE study with the IBE device. Looking at outcomes between the clinical trial and the real world experience, they were very similar. There was no aneurysm-related mortality, there was no recorded new-onset ipsilateral buttock claudication,
this is all from the IDE trial since we didn't have that information in the great registry, and looking at the incidence of reinterventions, it was similar both in the IDE clinical trial experience and also in the great registry as well. Looking at patency of the internal iliac limb, it was
93.6%, both at 12 months and 24 months in the prospective US IBE pivotall trial and importantly all the internal iliac limb occlusions occurred very early in the experience likely due to technical or anatomic factors. When we look at the incidence of type two endoleaks, we had previously noted there was a very high incidence of
type two endoleaks, 60% at one month, this did tail off a bit over time but it was still 35% at two years. A total of five patients in the pivotal IBE trial had a reintervention for type two endoleak through two years, and despite that high incidence of type two endoleak, overall the incidence of aortic aneurysm sac expansion
of more than five millimeters has been rare and low at two and nine percent at 12 and 24 months, and there's been no expansions of the treated common iliac artery aneurysm sac's at either 12 or 24 months. Freedom from reintervention has been quite good, 90.4% through two years in the trial and most of these
re-interventions were type two endoleaks. We now have some additional data out through three years in about two thirds of the patients we have imaging data available now through three years in the pivotal IBE trial, there have been no additional events, device related events reported since the two year data and through three years
we have no recorded type one or type three endoleaks, no aneurysm ruptures, no incidences of migration, very high rates of patency of the external and internal iliac arteries, good freedom from re-intervention and good freedom from common iliac artery aneurysm sac enlargement. And I think, in line with these findings, the guidelines
now from the SVS are to recommend preservation of the internal iliac arteries when ever present and that's a grade 1A recommendation, thank you.
- 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.
- So in terms of overcoming difficult access, when we're doing parallel grafting, and we're going to use more than one branch or parallel graft, typically we come in from the axillary artery. It gives good pushability, it decreases the length for what you need to get from you access point
down to the branch vessels. We find that no conduit is needed. We typically just access this in three offset manners. We'll put a purse string in at each site, so that there's limited bleeding. When you come in, you have to think about
what the aortic arch construct looks like. You can have a type one, a type two or type three arch, which can make things more difficult. As you can see here, this sheath takes quite a significant bend to get down to the renal visceral segment.
You also can have tortuosity within the thoracic aorta, which can compromise your ability to cannulate. So when we think about the arch, you want to think about coming in from the right or left, which ever one makes it better. Typically, if all things are equal,
we'll come in from the left side. When you get your sheaths down one at a time, we leave the stiff wire in to try to straighten out the anatomy. Sometimes you have to snare and get through and through access.
And then you want to think about where your sheaths position is. You want it to be high enough so that you can allow your catheters to form, but also low enough so that you can reach the vessel of interest.
There are a couple of things, I think from a pre-planning perspective that are very important to try to set up, to allow yourself the optimal chance of cannulating these vessels. Appropriate C-arm projections, you want to think about
whether or not your going to use a cephalad or caudad parallel graft. Think about the tortuosity as well as the composition of the branch. What type of stent are you going to use in that? How much purchase is needed?
How much purchase can you get? And, How difficult is it going to be to cannulate these vessels? And also whether or not there's orifice stenosis. So, here's an example of a patient we did. You can see that left renal artery
is actually quite anterior. If you look at the AP view here, you can see how it would be quite difficult to cannulate, 'cause the orifice basically runs into the aneurysm in the AP view, if you just move your II to a 30 degree RAO,
then it becomes very perpendicular and very easy to cannulate and see. This is a situation where you think about periscoping or caudad parallel graft. It's much easier coming from below, it's an upwards approaching renal artery.
Coming from above, you can see it can bow out towards that large aneurysm and also potentially reflux down into infra-renal segment. This is a patient with a very short branch of main renal artery, and you can see if you just put
a typical self expanding stent, there's a higher chance that this thing's just going to pull out into the aneurysm, and what we did here is, we put a balloon mounted stent, followed by a self expanding stent
to lengthen afterwards and it worked out really nicely. And this is just the patient that has significant orifice stenosis and these patients will be hard to cannulate. Sometimes you have to pre dilate before you introduce your stents into the vessels.
You also want to think about the aorta and what configuration of the aorta is. What's the tortuosity, the calcification. Are you in a situation where you're trying to cannulate within the aneurysm and how much thrombus is there as well.
So, you can see here in the first picture, the aorta's somewhat tortuous, and going after that left renal artery probably would be easier, but going after that right renal artery becomes potentially difficult
as the catheters and sheaths are going to be pushing you away, and may make that more challenging. You may want to think about things, and certainly catheters selection before approaching. And definitely, any time you have an aneurysm
and your in a big space without a lot of thrombus, that makes things a little more difficult, 'cause you're flopping around in a large open space trying to cannulate a vessel. When you're accessing the vessel sometimes from above, what will happen is the tendency is
for the catheters and the wires, to reflux down into that infrarenal space. This is a no not well known trick, where you put a coda balloon and you can have your wires and catheters bounce off of that coda balloon
to help you navigate into that branch vessel. Sometimes that doesn't work, and it still continues to reflux, and what we've done more recently is, we'll come in from below, put a four millimeter balloon
in the distal renal artery, and then we'll pin our soft wire, be able to do a catheter exchange, exchange for our stiff wire, and ultimately, there's the catheter, ultimately in the stiff wire.
And then ultimately bring in your stent graft, all with that balloon still in place to hold and pin that wire in position, and allow things to track over that wire, rather than reflux down. Just some general thoughts, again,
thinking about the appropriate catheters, what length catheter do you need, what kind of angulation do you need, stiff versus angle glide wires. We typically use Rosen and Amplatz wires for our stiff wires to track our stents in.
And then different platforms, depending upon what your anatomy ultimately looks like. So in conclusion, a lot of pre-planning is important, I think to optimize your accessing of these vessels. And there's a lot of techniques and technology, that currently exist to help assist with this.
- Thank you Jovanny. These are my disclosures related to this topic, ladies and gentlemen. We heard about fenestrated and branched grafts and we know we have two standard choices. And we personally like to tailor down the choice for each target vessel and this has resulted in many grafts
containing both fenestrations and branches. We know that a fenestration works well when a target vessel has 90 degree light takeoff and then the graft is in close contact to the aoritc wall. In contrast, a branch works well when it has a sharper takeoff and in an aneuryism where there is quite some
room between the main body of the graft and the ostium of the target vessel. And the question is what to do with not very suitable vessels where either choice is kind of not ideal and this is the inner branch as shown here, these different pictures that may fill in the gap between the
two standard choices. Inner branches in my opinion have some advantages. You have no risk of squashing the branch which can happen with a standard branch in a small diameter or in an angulated aorta. You have the option to manufacture your graft with a
wider body and this is very important because in graft that also have fenestration, again you would like your fenestrations to be as adjacent to the ostium of the target vessel. And with an inner branch, you need less fabric above the inner branch which means you use it for celiac artery,
you can stop lower in the aorta and reduce the risk of paraplegia. And finally, in cases within a branch and fenestrations where you orient your graft correctly, you may hope that your inner branches position so nicely that it cuts transition of the target vessel is much easier.
Just a few quick examples. Here we chose it for a difficult renal artery and we chose for two inner branches, which maybe is not the best choice for the right renal artery, but you see the technique with indwelling wires coming from above catheterizing the target vessels, then opening the
graft completely and this final result. As I discussed on Tuesday, it's also a good option for some post-dissection thoracic abdominal aneurysms. You see a celiac artery in the middle, that is clearly not a good case for fenestration and here we used our Bitle standard graft with one inner branch for the celiac
and three fenestrations for the other target vessels. And because we catheterized the fenestrations first, the graft oriented itself perfectly and the catheterization of the celiac artery through the inner branch coming out here was really instantly, and this is the end result.
And finally, a bit of a special case in a standard FEVAR type one endoleak that we had to repair with two inner branches for the renal arteries and the trick here was to open the graft only very partially to create some room between the already standard fenestrations and the inner branches and we were able to catheterize both then
open the graft completely, deployed stent everything with this end result. The reasons to use inner branches is always a bit of a combination, mainly a specific target vessel anatomy that is not very suitable for either standard solution together with a desire to keep your main graft open and
a combination between inner branches and fenestrations. Here are the most common designs that set one inner branch for the celiac and three fenestrations for the renal are two inner branches. We use the few inner branch grafts only and we stopped doing that because these grafts are very difficult
to orient and to position and I don't like them. Here, you see that we had indwelling wires in most of the inner branches, again an inner branch is on the inside that's more difficult to orient and to catheterize. And this is a slide with the technical details. We achieved success in all cases if you look specifically
at the inner branches with an indwelling wire, obviously in-stent access without indwelling wire far more difficult to catheterize it and the same with the target vessels. If you have a graft within a branch and fenestrations, the branch will be perfectly oriented and we really, literally fell into the target vessel and in graft
with only inner branches, far more difficult. We had five occlusions, all in renal arteries. Two out of five in the four grafts with branches only and four out of five in smaller vessels. You can see the distribution here. Would not be fair to blame the atrium because we used
far more atriums than other grafts, but it may be a good idea to have a more kink resistant and somewhat higher force breaching stent graft. And this is the last slide on the inner branches only. You can see it here, this graft was not perfectly positioned, crushed the breaching stent graft and
created an occlusion. Limitations, the inner branch ostium, the outgoing part has to be within the existing Z-stent, otherwise you can't manufacture it. So my conclusion is it is an interesting option, avoid grafts with inner branches only, but in combination with
fenestrations it will work very well. Thank you very much for your attention.
- Thank you. These are my disclosures. So, iliac artery can be your friend or your worst enemy, with cases of significant iliac artery occlusive disease. This doesn't mean you can't do it, but I always teach my fellows to give it the full meal deal.
I don't hesitate to dilate with the seven or eight millimeter angioplasty balloon, and then I'll follow that up with the dilators, and that gives me a good idea, if the dilator doesn't go up, it's time to consider some other route.
Rarely, I will do a conduit, and I usually will do this either with a purse-string in the distal common iliac artery, or a proper conduit with a synthetic graft, especially if I'm going to combine that with an ileofemoral bypass.
The thing to remember is you not only have to get the device up, you have to be able to turn it, and that's why I use those tips or tricks. Endovascular gear, we've already seen today a few speakers talk about some of the catheters and sheaths they like to have on the shelf.
I'll just take you through these. These are the specific ones I like to make sure I have. A stiff glide, and a Amplatz Super Stiff with a once centimeter tip, can again be your friend but also your enemy, so you have to treat those wires with respect.
And some people forget about that old trick of being able to put three 018 wires through a five French catheter, and that can sometimes get you deep into a superior mesenteric artery or a renal artery. Sheaths, I personally don't like
the angled sheaths from Cook. I find the Ansel One and Ansel Two sometimes work against you. I prefer to use the Raabe sheath, which is a straight sheath. The disadvantage of the Raabe sheath
is it comes with a very stiff dilator. So the tip here is just open the Ansel One, take out the High-Flex dilator from the Ansel One and put it up your Raabe sheath and that'll get you to where you want to be. The steerable sheath, Josh Adams did a great presentation.
It's an outstanding sheath. The only thing I would worn you is if you ride a tricycle through your whole life you won't be very good on a bicycle. So don't get too used to using a steerable sheath. Every once in awhile, just use it with the
old-fashioned catheters and wires before you, and open up the steerable sheath if you really need it. Beware short and downgoing renals. This is a trick sometimes you can use. Stephan Haulon showed this. You can drop, if you can't get any catheter
or sheath to follow, just drop a reverse catheter in, do the rest of the fenestrations, open up the top cap, and then put up a Coda balloon with your ipsilateral access, and you can use that Coda balloon to form a roof, and you can get any catheter or wire
to get into that tough renal artery. Beware of tortuosity, this really is your enemy. This, I have a low threshold just to go to a retroperitoneal exposure for either a direct puncture or conduit. There's nothing more demoralizing than deploying
a fenestrated graft, and if a lot of torque is built up into that because of those tortuous iliacs, you will see those fenestrations start to move as you deploy each stent, and that's sometimes an irretrievable situation. Renal artery occlusive disease used to be
a contraindication for fenestrated graft. It is no longer. Although, renal artery calcified and downgoing renals can really be a big problem, and always believe the CT, don't believe the angio. This is an angiogram of the same patient.
This does not depict what the real true story is. And with these particular cases, you know, most people in the room do not have access to customized fenestrated grafts, which sometimes you can use to help you with these cases. So this is a case that's interesting,
and what we did here is we basically came from above, pre-stented these with covered stents, and then that made the fenestrated graft on a second stage procedure, much easier. I didn't have to use any contrast. I could use these as my markers for the renals,
and in this particular case, I was able to use a steerable sheath for that short renal, and you can see how much that trajectory of that renal changed with that covered stent as well. Finally, this is a case that kind of highlights a lot of different tips and tricks.
This is a large aneurysm, juxtarenal with common iliac aneurysms, significant iliac and femoral artery disease. And so again, we kind of customized this. I'm not a big fan of snorkel and parallel grafts, but in this particular case I saw its use.
So I made a fenestration for the left renal and I planned to use a snorkel for the right because I couldn't get any kind of configuration to fit with the renal artery and SMA being on the same plane. So here I used that same balloon
for the iliac occlusive disease, to get the device up. You can see the issues here. There's the left renal coming off. I decided to fenestrate that and put a snorkel in the right renal, and this is what I did.
I was afraid that that fenestrated graft was going to cover the renal, so I came down from above just to mark the left renal. As I deployed the graft, I got out of the scallop, snared from the top, and then I brought a sheath down through the scallop, and I actually catheterized
the left renal from a downgoing perspective, and this worked quite well. I was able to snorkel right and then fenestrate the left, and we had an excellent result. And my final tip for you is don't go chasing endoleaks
with these long fenestrated procedures. If you have done the right procedure, all those endoleaks will seal. Thank you.
- Thank you very much again. Thank you very much for the kind invitation. The answer to the question is, yes or no. Well, basically when we're talking about pelvic reflux, we're talking really, about, possibly thinking about two separate entities. One symptoms relate to the pelvis
and issues with lower limb varicose veins. Really some time ago, we highlighted in a review, various symptoms that may be associated with the pelvic congestion syndrome. This is often, either misdiagnosed or undiagnosed. The patients we see have had multiple investigations
prior to treatment. I'm not really going to dwell on the anatomy but, just really highlight to you it is incompetence in either the renal pelvic and ovarian veins. What about the patterns of reflux we've heard from both Mark and Nicos what the pattern are
but, basically if you look a little more closely you can see that not only the left ovarian vein is probably effected in a round-about 60%. But, there is incompetence in many of the other veins. What does this actually have implication for with respect to treatment.
Implications are that you probably, if you only treat an isolated vein. There is a suggestion, that the long term outcomes are not actually as good. Now this is some work from Mark Whiteley's group because, we've heard about the diagnosis
but, there is some discussion as to whether just looking at ovarian vein diameter is efficient and certainly the Whiteley group suggests that actually diameter is relatively irrelevant in deciding as to whether there is incompetence in the actual vein itself.
That diameter should not be used as a single indicator. You may all well be aware, that there are reporting standards for the treatment of pelvic venous insufficiency and this has been high-lighted in this paper. What of the resuts, of pelvic embolization and coiling? The main standard is used, is a visual analog scale
when you're looking at pelvic symptoms to decide what the outcome may be. This is a very nice example of an article that was... A review that was done in Niel Khilnani's group and you can see if you look at the pre
and post procedural visual analog scales there is some significant improvement. You can see that this is out at one year in the whole. Now, this is a further table from the paper. Showing you their either, there's a mixture
of glue, coils, scleroses and foam. The comments are that, there are significant relief and some papers suggest its after 100% and others up to 80%. If you look at this very nice review that Mark Meissner did with Kathy Gibson,
you will see that actually no improvement in worse. There's quite a range there for those patients 53% of patients in one study, had no improvement or the symptoms were potentially worse. We know that those patients who have coil embolization will have reoccurrence of symptomatology
and incompetence up to about a quarter of the patients. What about varicose veins? The answer is there is undoubtedly evidence to suggest that there is physiological/anatomical incompetence in some of the pelvic veins in patients
who have recurrent varicose veins. Whether this is actually a direct cause or an association, I think it's something we need to have some further consideration of. As you know, there are many people who now would advicate actually treating
the pelvic veins prior to treating the leg veins. You can maybe discuss that in the question time. If we then look at a comparative trial. Comparing coils and plugs, you can see over all there really isn't no particular difference. If we then look again to highlight this,
which comes again from the Whiteley group. You can see that 20% of patients will have some primary incompetence but, it'll go up to around 30% if they are re-current. There is no randomized control data looking at this. What are the problems with coils?
Actually, a bit like (mumbling) you can find them anywhere. You can find them in the chest and also you can find that there are patients now who are allergic to nickel and the very bottom corner is a patient who's coils I took out by open laparotomy because they were allergic to nickel.
So, ladies and gentlemen I would suggest to you certainly, for continuing with pelvic embolization when doubtedly it needs some more RCT data and some much better registry data to look where we're going. Thank you very much.
- First of all let me thank Dr. Veith for the kind invitation to be here again and it's my great pleasure to share with you the preliminary result of our Indian registry. So these are my disclosures. So as vascular surgeon we have to admit that the Fogarty embolectomy has many possibility
but also some limitation. You can see here in this short video that we were able to remove thrombus, but thrombus was mixed up with plaque, hyperplasia and the final result was a very poor backflow from this vessel.
So already a couple of years ago we published our experience comparing the Fogarty embolectomy with the hybrid treatment that at that time was Fogarty plus a lot of endovascular rescue maneuver and of course hybrid was better, but we were very surprised by this.
What we found that the introvert in geography after Fogarty we had a number of chronic disease this is normal, but we also found a number of residual thrombus because firmly adherent to the arterial wall or just not appropriately reached by the Fogarty balloon embolectomy.
Even the over the Y Fogarty balloon embolectomy cannot work enough well. And then finally we also had a number of case with the injuries. Probably from inappropriate Fogarty balloon maneuver into the vessels so we had to find something more.
We had to find something less traumatic and so we realized that at the same time our colleagues from stroke unit, the neurologist had already a very nice tool in their hands. It's the Penumbra system which has began the market leader in stroke because it's very atraumatic,
dedicated for intracranial vessel navigation and then has a very high aspiration power system. So a couple of years later the company came on the market with the family dedicated to peripheral artery, the Indigo System from three to eight French catheter
designed for peripheral artery. So really improved trackability and atraumatic tip of this catheter. So how does the system work? You have already seen this video, but anyway you have first to engage the clot then you switch on
the aspiration power and then from proximal to distal you can remove all the thrombus, you can use the separator guide wire that breaks up the clot when ingested into the catheter and so the final result is that the tip of catheter is all we part and that you can remove all the thrombus
in very few minutes. Now I want to show to you my very first case it was four years ago and the system was not yet available and I for prefer I had some conflicting result with the other with competitors. I have incomplete reperfusion or hemolysis.
I have very positive feedback from my colleagues from the stroke unit at my University. I had the possibility to borrow the neuro catheters. So in this very first patients, unfit for lysis with a lot of thrombus, fresh thrombus in a vein popliteal area and the tibial artery I used
neural catheters, separate was very easy even at the beginning of our experience and we were able to engage the clot use the separator and removing in a couple of passage old thrombus even from the very distal localizations. So up to now we have used the Indigo family,
Indigo system in a lot of situation I can go through all this the one, but I want to show you how far we can go and it's a very challenging situation within dialysis dependent patients with the calcify kink and tibial artery and thrombus in the plantar arch
we were able to reach the plantar arch with the CAT 3 device and remove all the thrombus. Since then we have decided to collect data in a prospective national registry, the Indian registry. We want to collect 150 case in this prospective registry. We started last year and we actually included any kind
of acute lower limb ischemia embolism, thrombosis, graft endograft thrombosis, distal emboli and secondary to preceding intervention or even incomplete reperfusion after Fogarty and lysis. We evaluated the vessel patency by TIMI score of course we have now 136 patients enrolled by 17 centers active
and Ethiological hypothesis of the ischemia was in the 3/4 of case thrombotic, so the most challenging case. Acute and chronic ischemia mainly in very popliteal area or even below the knee or below the ankle in arteries. And here are preliminary result available for 120 patients.
After the Indigo use we already have a 90% TIMI two or three flow restoration will raise up to 96% after additional PTA or stent or additional lysis. So in conclusion these are only the preliminary result I hope to share with you our final result next year,
but at that moment we can already say that the Indigo is safe and effective option for acute lower limb ischemia, technical success is high even in small arteries, and up to now adverse event related to the device is very low and bleeding and hemolysis are not reported.
- Good afternoon, everybody. I think it's not uncommon for the vascular specialist to see a patient such as this with acute limb ischemia. And acute limb ischemia typically occurs commonly in a vascular unit. And the truth is of natural history is that the amputation rates are high whether or not
you intervene in them or not. The mortality though, is extraordinarily high compared to certainly chronic peripheral arterial disease, and even many cancers. Now, the etiology of acute limb ischemia is most commonly caused either by thrombosis or embolism,
and the goals of treatment, as you've heard in this session, are to restore perfusion to the extremity, to identify and correct underlying lesions if they exist, anticipate and treat reperfusion, and identify and correct embolic sources, if they are present.
Of course, there are two revascularization strategies, endovascular and surgical, and you heard a little bit about these. A recent evidence summary analysis looked at almost 3,000 articles. 563 abstracts read, 68 articles fully reviewed,
six randomized trials, and this is the business table that I'm going to translate to you here. So essentially, with all the literature out there, the composite 30 day mortality was higher with open surgery compared to endovascular therapy. There were similar short-term survival rates.
There were similar one year limb salvage rates, and the vascular therapy may reduce the need for open surgery, and this was shown in several randomized trials. Endovascular therapy is associated with more bleeding, and open surgery of course,
has the risk of surgical complications. And given all this data, and the debates that you've heard, the census is that given relative equivalence, endovascular therapy should be used as initial treatment of acute limb ischemia, unless there's obvious contraindication to that.
I want to focus a little bit about thromboembolism, and particularly, embolectomy that is commonly used to treat this problem. It's not uncommon to see such patients. I actually saw two such patients last week when I was on call.
Patients that come in with acute limb ischemia, caused by embolus. And of course, one way to treat this tried and true is using a surgical embolectomy using a variety of Fogarty catheters that are available. What we wanted to do is take a look at
the current state of affairs for results of treatment of these patients. We wanted to determine perioperative morbidity and develop a risk prediction model for postoperative mortality after lower extremity embolectomy.
And we did that by looking at the NSQIP database over a course of almost 10 years. We looked at emergent, unilateral, lower extremity embolectomy, and we excluded those patients who had either chronic ischemia,
bilateral embolectomy that suggested an aortic component, non-emergent cases, or patients who required a concurrent bypass. We had almost 2,000 patients in our cohort. Mean age was 68, and 48% were male. These comorbidities and demographics are
what you would expect to see in this patient cohort. Please note that a significant number of these patients, again, no big surprise, are functionally dependent. In terms of procedural details, 70% required an iliofemoral embolectomy for the groin. 17% required a popliteal embolectomy.
12% required a multilevel procedure, and almost 20% of patients required concurrent fasciotomies. In terms of 30 day outcomes of this patient cohort, 5% had MI or cardiac arrest. 16% had pulmonary complications. 8% had wound complications.
26% had to return to the operating room, and the mortality rate, 14% was quite high. In terms of resource utilization, these patients tended to stay in the hospital for a long time. 10 days on the average, and readmission rates were high. And so, when we looked at independent predictors of
30 day mortality, we found that functional dependence, chronic renal failure, steroid use, older age, recent MI or angina, and congestive heart failure and male gender significantly and independently effected mortality. Please note that functional dependence
and chronic renal failure had a significant effect, given their very high odds ratios. We then took these characteristics and constructed a risk prediction model where we then assigned points to the various characteristics.
And this model had a C statistics of .8, and basically, you can use this model to predict mortality. So, if a patient had more than 11 points, then the mortality is more than 50%. In conclusion, emergent lower extremity embolectomy has high morbidity, mortality and resource utilization.
In patients with acute limb ischemia requiring embolectomy, among other factors, functional dependence and chronic renal failure are highly associated with increased perioperative mortality. And our scoring system can help inform consent process and alternative treatment decisions
such as providing palliative care to this complex patient population. Thank you.
- Yeah now, I'm talking about another kind of vessel preparation device, which is dedicated to prevent the occurrence of embolic events and with these complications. That's a very typical appearance of an occluded stent with appositional stent thrombosis up to the femur bifurcation.
If you treat such a lesion simply with balloon angioplasty, you will frequently see some embolic debris going downstream, residing in this total occlusion of the distal pocket heel artery as a result of an embolus, which is fixed at the bifurcation of
the anterior tibial and the tibial planar trunk, what you can see over here. So rates of macro embolization have been described as high as 38% after femoral popliteal angioplasty. It can be associated with limb loss.
There is a risk of limb loss may be higher in patients suffering from poor run-off and critical limb ischemia. There is a higher rate of embolization for in-stent restenosis, in particular, in occluded stents and chronic total occlusions.
There is a higher rate of cause and longer lesions. This is the Vanguard IEP system. It's an integrated balloon angioplasty and embolic protection device. You can see over here, the handle. There is a rotational knob, where you can,
a top knob where you can deploy, and recapture the filter. This is the balloon, which is coming into diameters and three different lengths. This is the filter, 60 millimeter in length. The pore size is 150 micron,
which is sufficient enough to capture relevant debris going downstream. The device is running over an 80,000 or 14,000 guide-wire. This is a short animation about how the device does work. It's basically like a traditional balloon.
So first of all, we have to cross the lesion with a guide-wire. After that, the device can be inserted. It's not necessary to pre-dilate the lesion due to the lower profile of the capture balloon. So first of all, the capture filter,
the filter is exposed to the vessel wall. Then you perform your pre-dilatation or your dilatation. You have to wait a couple of second until the full deflation of the balloon, and then you recapture the filter, and remove the embolic debris.
So when to use it? Well, at higher risk for embolization, I already mentioned, which kind of lesions are at risk and at higher risk of clinical consequences that should come if embolization will occur. Here visible thrombus, acute limb ischemia,
chronic total occlusion, ulceration and calcification, large plaque volume and in-stent reocclusion of course. The ENTRAP Study was just recently finished. Regarding enrollment, more than 100 patients had been enrolled. I will share with you now the results
of an interim analysis of the first 50 patients. It's a prospective multi-center, non-randomized single-arm study with 30-day safety, and acute performance follow-up. The objective was to provide post-market data in the European Union to provide support for FDA clearance.
This is the balloon as you have seen already. It's coming in five and six millimeter diameter, and in lengths of 80, 120 and 200 millimeters. This is now the primary safety end point at 30 days. 53 subjects had been enrolled. There was no event.
So the safety composite end point was reached in 100%. The device success was also 100%. So all those lesions that had been intended to be treated could be approached with the device. The device could be removed successfully. This is a case example with short lesion
of the distal SFA. This is the device in place. That's the result after intervention. That's the debris which was captured inside the filter. Some more case examples of more massive debris captured in the tip of the filter,
in particular, in longer distance total occlusions. Even if this is not a total occlusion, you may see later on that in this diffused long distance SFA lesion, significant debris was captured. Considering the size of this embolus,
if this would have been a patient under CLI conditions with a single runoff vessel, this would have potentially harmed the patient. Thank you very much.
- Well, thank you Andrej, I will present you the minimal invasive segmental artery coil embolization for prevention of spinal cord ischemia during EVAR of thoracoabdominal aortic pathologies, our initial clinical results. As all, I have nothing to disclose related to this presented topic.
As all we know ischemic spinal cord injury has a high incidence up to 20% after open or endovascular repair of thoracoabdominal aortic aneurysm and this is despite conventional perioperative neuroprotective strategies such as blood pressure management or continuous CSF drainage and also despite staged aortic repair such as
staged endovascular repair or temporary aneurysm sac perfusion. That's why our opinion is that, we have to have a pragmatic approach for prevention of spinal cord ischemia. First, our opinion is that you've to revascularize as many inflow arteries as possible such as
subclavian or hypogastric artery. You've to optimize your hemodynamic management perioperatively and last but not the least, we think that you've to improve your strategies that induce development of collateral arteries, that means, you have to ischemic precondition the spinal cord.
The ischemic preconditioning of the spinal cord is based on the collateral network concept of the spinal cord perfusion and that means that the hypothesis of spinal blood supply depending mainly on the critical arterial input of the Adamkiewicz artery is obsolete. As you can see here, of some of our intraoperative images
that blood supply of the spinal cord is guaranteed by two nal and intraspinal compartment And from this compartment, there are very small arteries, you can see here on this image. The anterior radiculomedullary artery, that gives further
supply to the main spinal cord artery, the anterior spinal artery. So, based on this concept, we developed ischemic preconditioning and that means that we occlude the main stem of several segmental arteries in order to preserve the capability of
paraspinous collateral network to build new arteries and we do that by minimal invasive staged occlusion of the segmental artery and basically this is an entirely endovascular first stage of a staged approach for thoracoabdominal aortic repair to reduce the ischemic injury of the spinal cord.
The procedure performed local anesthesia with a percutaneous trans-femoral access with a small bore sheath, the patient is awake, there has no cerebrospinal fluid drainage and we perform the clinical monitoring of the patient for at least 48 hours after the procedure. I won't go in details about the procedure, Andrej will let
you guide you through, I will show you our data. You can see, here between September 2014 and December 2017 we've treated 57 patients with MISACE in our institution. You can see here the characteristic of the patient. 75% were male with mean age of 69.6 years of age all over they were hypertension, and most of them, 39, had a
extensive Crawford type II and type III aortic aneurysm. The mean aortic diameter was 62.7. Some of them, they had previous repair of the aorta and 94% were atherosclerotic in all age. So, how do we perform the procedure? So, we look, we've, we look at our CT scan of the patient
and we know from the pre-planning where the aorta will be covered. And in this area, we look at the segmental arteries and we count the segmental arteries, we don't only count, also mark the segmental arteries that will be covered by the stent grafts.
And, you can see here in median we had nine open segmental arteries of this area ranging from 2 up to 26. Then we start the coiling procedure and you can see here that 38.6% of patient had only one coiling session, 42.1% had 2 session of Minimally invasive coil embolization and 19.3% of the patient had more than two stage coil.
And you can see here that, between those two coiling sessions, we had mean interval of 60 days. And you can see here that we have performed maximum five sessions per patient and during those sessions we've coiled maximum six segmental arteries and per patient we've coiled up to 19 segmental arteries
and median was number of 5. You can see here distribution of the segmental arteries after MISACE at the level of the planned aortic coverage. With blue, sorry with dark, it's the, they're segmental arteries were already occluded, with grey it's segmental arteries that we've already coiled
and with red is segmental arteries that we've not coiled. Again this is the first initial clinical experience and at the end of the entire coiling procedure, we've occluded median 77.7% of the entire segmental arteries of that level. You can see here the characteristic of the
coiling of session. You can see here that basically between the first and second sessions, they're not too many differences, the third session is quiet quicker and we've no spinal cord ischemia after this coiling sessions and we've some minor complication like quarter of our patient developed
backpain which resolved with NSAIDs, we had lost two coils, we were able to recover and we were unable to occlude one segmental artery in three patients. After seven days but no sooner than that, in order to let the collaterals of spinal cord to develop, we performed the complete aneurysm exclusion of these patients.
You can see here, 55 of our patient were completely excluded in the mean time of 83 days. To mention that, two patients died waiting for the CMD graft due to the cardiac problems not related to the aneurysm pathology. You can see here the characteristic of the TEVAR procedure.
You can see here we performed, all type of stent grafts from tube stent-graft to fenestration branch combined stent graft. In one patient, we've the subclavian coverage on the left side and in 80% of the patients the hypogastric are true or patent.
To mention that, the length of the covered aorta in our cohort was 270 mm. After the complete repair of the thoracoabdominal aortic aneurysm, at 30 days, you can see our result, we've no spinal cord ischemia in this patient, one patient died due to related aneurysm problem.
And by looking at this data, we conclude that the first experience suggest that the minimal invasive segmental artery coil embolization is feasible, safe and in our opinion, effective but can be challenging and it's a new field with a many open questions. And we think that the ultimate proof of this technology
of this procedure requires randomized trial which is currently underway, this PAPA-ARTiS trial, paraplegia prevention in aortic aneurysm repair by thoracoabdominal staging with MISACE. Thank you for your attention.
- BEVAR through the false lumen, it's rarely indicated. These are my disclosures. And usually, we proceed through the true lumen using BEVAR for post dissection aneurysm like in this case. From our experience, Regensburg and Nuremberg, at the moment the biggest surveys of 71 patient with post dissection aneurysm published
this year in European journal of Vascular and Endovascular Surgery. Sometimes it's necessary to go through the membrane from the true to the false lumen because of the urging of the arteries. And it was necessary in 14 out of 261
target vessels in this material. It makes about 5%. But sometimes, we have a very different cause of the chronic dissection. Like in this patient, where the true lumen shows a very big opening for the false lumen
and ends at the level of the renal arteries. And both legs are only perfused by the false lumen. So, what to do, and it was already some years ago, we decided to make a bypass from ascending to both femoral arteries and pseudoextenders use TEVAR for the aneurysm of the descending aorta.
Now, a case presentation, a 55 years old male patient with hypertension and nicotine consumption. He has had acute aortic dissection, 2014 with a true lumen collapse and dissection of superior mesenteric artery. He has had malperfusion of his intestine and right limb.
At that time, he was treated just by femoral-femoral bypass from left to the right and right hemicolectomy due to ischemic complication. Between 2014 to 2017, this dissection still started at the level of left subclavian artery. The aneurysm was progressive to 63 mm.
He has had the complete thrombosis of the thulomen at the level of the right renal artery with atrophic right kidney. He has had celiac trunk, left renal, and inferior mesenteric artery from the false lumen and dissected superior mesenteric artery.
The first procedure was in October, 2017 with the branching and the Amplatzer to the left subclavian artery to prevent retrograde flow. Branch device and uni-iliac tube because of occluded right iliac artery. After the first operation, we have seen
thrombosis of the thoracic aorta and patent segmental arteries at the level of celiac trunk. The second operation was deployment of covered stentgrafts balloon-expandable covered stentgrafts to the superior mesenteric, left renal and inferior mesenteric artery, why?
If you remember, the patient has had mesenteric dissection and only the right hemicolectomy. So we try to preserve all the collaterals to the intestine. And the third procedure, after balloon occlusion of the celiac trunk and branch, drainage, MEPS, and intrasaccular pressure measurement
was a completion of the celiac trunk with two stent grafts. Preoperative CT, a staged procedure with open aorta at the level of renal and mesenteric arteries, and then completion postoperative with all arteries perfused. Now, what we learned after this.
We may have different methodology. This patient is stable, the reconstruction is well-functioning after 12 months of follow-up, but we should always remember to tailor the procedure to the morphology, it is one of the ways. Thank you very much.
- [Ali] Thank you Dr. Jordan This is the results of the trial that led to the FDA approval of the Valiant Captivia Device for treatment of aortic dissection. This is a four-year update. I have no disclosures.
This is the epidemiology of aortic dissection. As you know, the outcomes of patients with acute complicated type aortic dissection leave a lot of room for improvement. With the open-repair operative mortality approaching 50-80% when there is mesenteric or renal ischemia.
The goal of TIVAR is to stabilize the aorta and promote remodeling. This includes covering the proximal entry tear. Treating or preventing rupture to expand the true lumen, caused false lumen regression and false lumen thrombosis and to alleviate distal malperfusion.
As you know, TIVAR is now considered first line therapy for patients with acute complicated type aortic dissection and this is the current European Society for Vascular Surgery guidelines. The objective of this study was to evaluate the performance of the Valiant Captivia device
for treatment of acute complicated type aortic dissection. 50 patients were enrolled at 16 US centers. This occurred between 2010 and 2012 and the patients are being followed up for five years. This the baseline demographics. As you can see, hypertension was prevalent.
Most patients were ASA Class IV or V. Vascular history and hypercholesteremia were also prevalent. The average age was 57 and 80% of the patients were male. This is the presentation symptoms. The majority of patients presented with back or chest pain
and a staggering 86% of the patients had malperfusion. 40% has visceral ischemia. 42% had renal ischemia. 40% lower extremity ischemia and 6% spinal cord ischemia. Antihypertensives were administered to 84% of the patients with ionotropic support required in 16%. This the procedural data.
There was a 100% delivery and deployment success. The proximal entry tear was covered in 100% of the subjects. And there was no misalignment noted. The over-sizing was 12 +/- 10% and the length of coverage approached 20 cm. This is the all-cause mortality.
The freedom from all-cause mortality at four years was 77%. As you can see, outside of the 30-day window there were no moralities directly attributed to aortic dissection. There was one pnuemonia on day 87
which according to the clinical adjudication committee was ruled as a dissection-related death but it wasn't a direct aortic-related death. This gives us a four-year freedom from dissection-related mortality which is 90% and for a complex group of patients
with acute complicated type aortic dissection this is remarkable. This graph also shows that there's been aortic stabilization with TIVAR and no late complications related to the aorta. There were no serious adverse events or secondary endovascular procedures in year 2, 3, or 4.
There were some procedures related to the dissection. Four patients had extension and one patient had embolic placement. And one patient had a subclavian plug. This is the aortic remodeling data. As you look at the four-year data
the maximum diameter of the false lumen decreased or remained stable in 87% of the patients. The maximum diameter of the true lumen increased in 100% of the patients. And there was partial or complete false lumen thrombosis in 96% of the patients.
In summary, there was 100% delivery and deployment success. There was aortic stabilization through the four-year period. There were no ruptures and at 4% retrograde type aortic dissection given this viable pathology. This is favorable aortic remodeling
with low need for secondary endovascular procedures. Thank you very much for your attention.
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