- [Domenico Valenti] I would like to thank Frank Veith for the kind invitation. I have no disclosure to make. Almost 14 years ago, Doctor Archie stated very well, in his invited commentary on Ross Naylor's Camiade paper. The carotid bypass is an acceptable alternative method of carotid reconstruction, and it should be
in the repertoire of every surgeon undertaking a carotid endarectomy. Few years later, Doctor Ricco validated Doctor Archie's statement in his very large prospective study where carotid bypass should be a durable and safe procedure,
with a primary patency rate of 97.9%. Recently, carotid stenting has been advocated as a complimentary technique, but mainly for technical defect detected during the, after the carotid endarectomy, on completion study or immediately post-op
rather than a bail-out procedure for a failed endarectomy. At King's, we are indeed adding bypasses in our repertoire and all the bypass were performed mainly for a bail-out procedure but two, were post radiation stenosis.
We are all familiar with the Gore Hybrid Graft, which is a novel technique, probably natural evolution of the aortic technique as an heparin-bounded PTFE, we've got a Nitinol stent, this constrained and allowed a sutureless anatomosis. Almost three years ago,
after a disaster carotid endarectomy, I decided to use a hybrid graft instead of the standard PTFE, and last year I presented here our initial experience with the hybrid graft. The implantation technique is very straightforward,
the graft is surgeon-friendly, and basically with a constrained stent, it's almost the same size of a pretty narrow shunt, is inserted under direct vision inside the internal carotid artery. Then when the stent is in place,
almost two and half centimeter inside the internal carotid artery, the deployment line is pulled, keeping parallel to the PTFE, and sutureless anastomosis is performed. The proximal anastomosis is done in the usual fashion,
end-to-end, using 6-0 prolene suture, I tend to re-implant the external carotid whenever it's possible. This is what it looks like in real life, it's patient with postural degradation, severe contralateral occlusion,
the carotid hybrid graph, and you can see the immediate post-op CT angio with the pen that show the good patency of the graft. So far, we implanted the 19 cases and in this table you can see the reason for conversion. All the patients were enrolled in very strict
surveillance programs with DuploScan and CT angiogram. We completed 36 months of follow-up and during the follow-up, three cases occluded, one at six, one at 12 and one at 24 months. The common denominator for the ones occluded at 12 and 24 months is both patients
had stopped clopidogrel at six months. During the follow-up period, four stenosis for re-stenosis were detected, there were two minor, one moderate, one severe, and again, the common denominator on the severest and restenonsis was the patient stopped clopidogrel after six months.
This one is particularly the case, you can see in the post-op CT angiogram will show a good patency of the hybrid graft in 2015 and last September the patient developed quite severe 95% restenosis. The Capper-Meyer analysis on the hybrid graft
in carotid surgery shows 78% primary patency rate. In conclusion, ladies and gentlemen, carotid endarectomy still remains the gold standard, a carotid bypass with a standard PTFE graft is a safe and durable procedure, Gore Hybrid Graft for carotid surgery
is a novel technique with a reasonable 36 months patency rate, in our experience, why all the occlusion were probably associated with the stop of one of the dual antiplatelet treatment, we recommend to continue the dual antiplatelet treatment
long term, and the long term follow-up is necessary in order to establish the durability of this novel graft for carotid surgery. Thank you very much indeed for your attention.
- [Dr. Brian DeRubertis] Thank you, Dr. Walker. So, there's a lot to cover in five minutes, but I'm going to do my best. Basically I'm going to approach this as an evidence-based approach to what we do in the SFA and popliteal. The problem with an evidence-based approach in this area is that there's a lack of comparative outcome data.
And even when we do have good data, the devices within a category might not be equivalent. Despite these issues, we do have some reasonable quality evidence to make some concrete statements about either the right or the wrong way to treat the SFA, or at least make some statements about
what is or is not likely to work. So obviously the Holy Grail of data is randomized, controlled clinical trial data. That said, there's a growing recognition that prospective multi-center registries with core lab adjudication can be helpful in terms of determining how
a device does in a real world setting. So these are some of the devices that we use commonly today. I'm going to take these apart one by one and show some of the data to support or refute use of some of these. So beginning with the question of Balloon Angioplasty versus Nitinol Stents
We of course began using self-expanding Laser-Cut Nitinol Stents is the SFA in an off-label fashion. Now, over the past decade all of the major manufacturers have gotten an on-label indication for these stents. And these clinical trials were all basically the same design, which is randomized controlled trials
between bare metal stenting, provisional stenting and balloon angioplasty. And they all showed a similar phenomenon, which is primary patency of balloon angioplasty is in the range of 30-50% in these relatively simple lesions while those patients... who had self-expanding laser-cut nitinol stents
had about a 60-80% primary patency rate. So there is good randomized controlled trial data to show the primary patency of bare metal stents is better than balloon angioplasty alone. Now that said, there's some issues in terms of reinterventions and durability of these stents over time,
which makes us wonder if there's a better solution with a drug-coated stent. The one drug-coated stent that's on the market now, of course, is Zilver PTX and the Zilver PTX trial is a randomized, controlled trial that is randomized between provisional stenting with Zilver PTX versus
angioplasty or selective stenting with bare-metal Zilver. The results of this trial are interesting in the fact that not only do we see an improvement in one-year primary patency, this is now a trial that has five year results, showing a sustained improvement in primary patency all the way out to five years.
So this is, again, pretty compelling evidence that bare-metal stenting plus a Paclitaxol coating improves primary patency over angioplasty alone. Even out to five years. Now in terms of atherectomy this is the difficult one because of the fact that, number one, there are really very
few, if any, comparative trials with atherectomy and if you look at the available devices on the market now listed here, these are all very different in terms of their mechanism of action and probably their safety profile as well. That said, there are some themes we see in this literature.
One of the issues is that many of these trials are very small in size and even those trials that do have a large size have a very limited amount of primary outcome data, or relevant outcome data. One of the exceptions to this is the DEFINITIVE LE trial, which is an 800 patient trial with
angiographic core-lab adjudication of the lesions and relevant primary patency data at a year. One of the things that's common in these atherectomy trials, of course, is that the complication rate is a little higher than what we see in bare-metal stenting or angioplasty, and the bailout stent rate is universally low on these.
So it shows that stenting can be reduced by the use of these devices. It shows the primary patency of the claudicants in the DEFINITIVE LE trial and the limb-salvage rate in the CLI patients. So fairly good results, or what we call stent-like results
without leaving a permanent implant behind. One of the other pieces of data to be aware of in the atherectomy world is the EXCITE ISR trial which showed that the spectranetics laser catheter did better than balloon angioplasty alone for instant restenosis.
The problem with this, of course, is that we typically will use anti-restenotic drug in these days when we deal with restenosis, and that's where the issue of drug-coated balloons versus primary balloon angioplasty comes up. Obviously there's now three clinical trials
that have shown improvement with primary patency in those patients treated with DCBs over plain angioplasty alone. That said, there's a growing recognition that increased lesion length and increased lesion calcification is an impediment to success with DCBs.
This was confirmed in the IN.PACT global registry which basically showed very good results with even long lesions, up to 26 centimeters, but a high rate of stenting, up to 40%. So it does seem that we do have good evidence for use of DCBs, but there are some limitations for these devices.
So I think stents will still stick around and be necessary, which brings up the question of next generation Nitinol stents. There's two interesting ones on the market: the Gore Tigris stent, which was evaluated in a randomized, controlled trial against the Lifestent
and while this did show an improvement in reduction in stent fractures, it unfortunately didn't show any difference in primary patency at the two-year end point. So the use of this stent is still to be determined in terms of it's utility. The SUPERB trial showed the results for the IDE trial
for the Supera stent, and those of us who use this recognize the crush resistance of this stent, which is significantly better than normal Nitinol stents, or laser-cut stents, which allows it to withstand this degree of calcification. The SUPERB trial showed very good results at one year,
with those stents that were nominally deployed. And so there's prospective registry data for use of, to support the use of Supera. So I would say, in conclusion, the evidence to judge effectiveness of old and emerging technology is incomplete but improving.
Plain balloon angioplasty and bare-metal laser-cut nitinol stents are probably below the standard of care in this day and age. Atherectomy may be an effective tool for reducing bailout stents, stent rates. And Paclitaxol coating does seem to be effective at
reducing restenosis both on stents and baloons, but as lesion complexity increases we probably are going to be needing to use stents still, and likely some of the next generation stents should be ideal for these purposes. Thank you.
To conclude, interventional radiology provides percutaneous therapeutic techniques for the treatment of symptomatic disc herniations and these techniques are efficacious with a success rate approximately 80 to 85%,
save with a complication rate below 0.5% and they can be attractive alternatives to endoscopic surgical techniques with a longer lasting effect than conservative therapy. Thank you very much. (applause)
- [Ourania] Thank you, I would like to thank the organizing committee for this kind invitation, especially Dr. Veith, whom I know since I was a resident in New York. So the topic is elephant trunk, frozen elephant trunk, as well as updates on the Thoraflex graft. So traditionally, the elephant trunk is a procedure
that has been done for ascending arch and thoracoabdominal aorta. It's been done in two stages, with the second stage being open thoracoabdominal approach or endovascular approach, and this depending on the visibility for endovascular repair for the distal thoracic aorta.
A lot of times, we have hear that frozen elephant trunk and the hemiarch with antegrade stent delivery, but the reality is that this is not really a frozen elephant trunk and does not involve any manipulation of the head vessels. So the problem with elephant trunk technique
is the cumulative mortality, and as we have heard from Dr. Svensson and others, is that we can see that the cumulative mortality can be up to 35%. So these actually really call for alternative procedures, as what actually here we have a simplified version of the frozen elephant trunk that we just went
to published and came out as a CME article in The Annals of Thoracic Surgery or as a single-piece device. So this is, and this study was a five-year study, 129 patients who were actually treated aneurysms as well as chronic dissections,
and we had total of 37 patients with a frozen elephant trunk. We have mention this technique quite a few years ago. It's basically, this is a vascular Terumo graft, and inside the trunk of the elephant trunk, under direct visual, we place a wire
and we insert a Gore graft. And we can do this with the intent to treat the entire pathology, this is in one stage, or we can do it as a two-stage repair by just having a stent inside the Dacron graft that actually facilitate the second repair
by advancing a stent inside a stent and not inside a Dacron graft, and also, with regards to the postoperative care where the two stages can be a little more beneficial for the patients. Now as we know, one of the Achilles heel
of this operation is actually the spinal cord ischemia, and we did have two patients with spinal cord ischemia for the frozen elephant trunk group. And, what we notice is that actually happen when we did it as one single-stage repair. So over times, actually, one the things that we
try to do now, is that we avoid the single-stage repair. It's much easier for the patient to come for endovascular repair if that is the case. For the second stage, the procedure can be done in the regular operating room, and we don't need any fluoroscopy or dye.
With regards to the one-piece device, this is the Thoraflex or the E-vita, it is not currently available in the United States. This was done in Europe. Especially in Germany, they have used the Thoraflex. This is 100 cases published by Dr. Malakh Shrestha
and Dr. Bartolomeo with the registry, and we can see here that the main advantage is a single-stage procedure, is a single ECMO device, there's no ECMO two devices, but of course, the cost of the device as well as the increased risk for spinal cord injuries, one of the disadvantages.
With regards to the Thoraflex trial, again, we don't have a single device in the United States. Currently this trial is on the way, and my partner, Dr Coselli, is one of the, is actually the principal investigator. The indications for the trial is aneurysms,
dissection, as well as rupture. Currently we have 12 sites, and as per October 2017, there're 40 patients enrolled, and the device is actually is two kinds of devices, the plexus that has this arch aortic vessels, and then is the Ante-Flo device,
and there's no hemiarch vessels, just a single branch to perfuse distally. This is nitinol, this at most the ring of the stents and we can see over here, there are radiopaque markers. This is the delivery system, the strap, the splitter, the releasing of the clip,
and here I'm going to show you a very short video where actually we perform total large as well as proximal endovascular repair of the descending thoracic aorta. A widest comes in with the retrograde, we don't really need to do this particular step.
That was one of the first cases, and we did it. The device is going to hold it down into the descending aorta. The strap is pulling it back, (mumbles) the device, and then, the splitter actually is opened. And then after that, we have the aortic graft
and we preform the distal anastomosis here as well as anastomosis of the head vessels. So, as a conclusion, the flow's in elephant trunk can be a simplify repair. Of course, judicious use is needed. A long-term evaluation is necessary.
And can permit the flexible as well as contemporary approach of the open arch repair. Again, I would like to thank the comittee for this great invitation.
- [Presenter] Thank you very much for the invitation, and thank the speakers, the chairmans. My disclosures, this is our current protocol for treating endovascular thoracoabdominal aneurysms. CSF drainage, blood pressure management,
preserving left subclavian, hypogastric artery, are already stressed. We like to stage TEVAR stage first, especially for type II aneurysms, and for the implantation of the branched graft,
we use motor evoked potentials to selectively open or close last branch. And what we do, is connect three branches, occlude the last branch for 15 minutes, and then decide whether to leave the branch open. At first, we only used motor evoked potentials
for that drop of 50%, but I'll explain you why we added angiography during this phase, and sac pressure measurements, because we had some failures. And we hope to identify patients
who are at risk for paraplegia, and who benefit from staging. Motor evoked potentials are all clear, they can be influenced by spinal cord ischemia, but also, peripheral ischemia can lower your motor evoked potentials,
and this can happen because we occlude arteries to the legs by large sheets. Here, a typical example, the first red line, the monitoring of the right leg is going down because of peripheral ischemia, and it recovers after removing the sheet,
and during implantation of the branched graft and branches, nothing happens until we occlude the last celiac branch in this case, and both right and leg monitoring go down as a indication for spinal cord ischemia,
and so, we decide to stage this patient. What you want to be sure of, and that's why we changed this, is that we will really exclude the aneurysm during this branch test. So, what we added was blood pressure measurements,
and we removed the guide wire of this balloon, and measured the pressure inside the aneurysm, but also added an angio, and in this angio, you see during branch tests a large end leak. So the aneurysm is not occluded,
and branch test is not valid. Of course, it's better to occlude both the branch and side branch by balloon, but because we measure pressure through the guide wire channel, we can't measure pressures during this phase.
Three ways of staging, and a lot of patients have already historical staging because of previous aortic surgery. TEVAR staging and what we're focusing on is to selectively use open branch staging. Up to now, 103 patients,
you see division in all types of thoracoabdominal aneurysms, and our number through the years. A lot of these patients, 28%, had historical staging. Almost 60% previous thoracic procedures. In 9% we use TEVAR staging, especially type II patients
with carotid subclavian bypasses, and in almost 1/3 of the patients, we added open branch staging, with using the protocol we described. When we analyzed the data, the decrease of motor evoked potential
was in 86 patients. The reason for staging in 14 cases because of an endoleak, and we never used the sac pressure as a reason for staging. If you look at these sac pressures, there are absolutely related
to the presence or absence of an endoleak, but are not related to a decrease of stable motor evoked potentials. So, we have a 10% hospital mortality, mainly before 2014, and spinal cord ischemia is startling 6% in the survival group,
which are all delayed, mostly paraparesis, and five of the six patients can walk, and improved. So, we have 1.2% complete persistent paraplegia in this group. So, in conclusion, the combination of the use of Motor Evoked Potentials and angiography
during branch occlusion is associated with a low spinal cord ischemia rate during endoTAAA. Sac pressure measurements in our hand do not contribute to decision making, and the open branch staging,
it can be avoided in 64% of the cases, resulting in 6% spinal cord ischemia, and only 1.2% complete and persistent paraplegia. Thank you.
- [Athanasios] Thank you Mr. Chairman. Thank you, Dr. Veith, for the invitation to be here again in New York this year. These are our disclosures. And this is the new Zenith Alpha Thoracic endograft. And as you see here, this is a two-piece modular system with a separate proximal and distal component.
And it's important to note here that the distal component has also a bare stent with reverse hooks in order to provide aortic fixation and aiming to prevent upward cranial migration. Furthermore, this is a low-profile introduction system, we have already heard about that today,
with obvious advantages for both small access vessels and percutaneous access whenever needed. Additional features include the highly-flexible inner Nitinol cannula, as you see here, which could help eliminate the bird-beaking effect. But the most important feature in this graft, in my opinion,
is now the simplified deployment mechanism. And as you clearly see here, there's a new captor sleeve which reduces the friction and pull-back forces significantly so we can now, very easily, unsheath the graft. And there is a new rotational handle
which enables for a more controlled, simple and precise deployment and opening of the bare top stent. We have used this graft so far in Nuremberg in 100 patients, as you see here, in 52 of them, as a TEVAR alone procedure, and in 48, as part of a
thoraco-abdominal branch graft procedure. Now, for the next slides of clinical outcomes, I will focus on the TEVA alone experience which is a more concise patient group. And starting with an indication we see here, the most common reason was a distal arch
or thoracic aortic aneurysm, followed by a Type B aortic dissection. Please note that half of these patients were treated at the acute phase emergently. If we look at this slide, we see that 23 patients, or almost half,
required also additional procedures in order to obtain a good long proximal landing zone, either with a complete or partial aortic arch debranching or even two patients with a chimney technique of the superior aortic vessels. If we look at the early outcomes,
technical success was at 96.2%, with a 32-day mortality of eight patients or 15% all in acute patients. Spinal cord ischemia was noted in three patients, in one as permanent and in two as temporary paraparesis. And fortunately, there was no permanent paraplegia
in this cohort of patients. During follow-up with a mean duration of 11 months, we had an estimated survival of almost 80%. We did have one related mortality. This because a patient had developed an aortoesophageal fistula after being treated acutely
for a ruptured myocardic thoracic aortic aneurysm. A total of five re-interventions were needed. Three patients required a distal stent-graft extension and two, an embolization of the left subclavian artery to treat a Type II endoleak. Now let's go through some clinical examples.
Starting with this one, this lady presented with a acute contained ruptured thoraco-abdominal aortic aneurysm. And if you look at the pre-operative CTA we see a hostile anatomy, a highly angulated descending aorta
and a hostile aortic arch which, however, was not a problem for the Zenith Alpha. You see how nicely it was able to take the curves and when we deployed finally, quite accurate to the graft, showing in the final angiography, and very good conformability of the device,
despite the hostile aortic arch anatomy. And this the result at one year showing still a very good clinical outcome after the operation. Another patient, not really straightforward, came in with a disconnection
of the two previously-placed thoracic grafts, so a big endoleak. And, again, in a highly angulated thoracic aorta, as you see here, we could have done as a through and through wire via an axillary access. And over this wire and despite this high angulation,
we were able to put a new Zenith Alpha to bridge the two disconnected grafts with a good final result. As you see here there is a still a small Type Ib endoleak which have now planned to extend. So, to conclude dear colleagues, ladies and gentlemen,
to my opinion, the Zenith Alpha Thoracic graft is a clear improvement. It's a low profile system with obvious advantages as already discussed. It offers now an easier and more controlled proximal deployment
and it's also a flexible and conformable device, which is also the reason why you use this graft also now in dissections. Durability, up to now, is not an issue, but of course we have to wait and see with longer-term follow-up.
Thank you very much for your attention.
- [Lecturer] Here's my disclosure. While this work's been done with the help of Cook, and this was the device that we started out with. Caudally oriented cuffs, and barbs, and a taper. And, this is the device we work with now, essentially the same features. Of course with proximal and distal extensions
to accommodate more extensive anatomy. And you would think with all the components and all the connections and all the hemodynamic pounding that these things would last about 15 minutes. But, we're very gratified to note that we were wrong in that expectation.
And that late occurring complications, that is not persistent early complications, late occurring complications are really very rare. A commoness by far being renal artery occlusion. Freedom from aneurysm related death is actually very low. And the repairs do appear to be durable.
But there are a couple notable exceptions. This particular patient had an aortic dissection, chronic dissection with type two aneurysm formation. And here you can see the problem. He's got blood going down the true lumen of his SMA and back up the false lumen.
And try as we might, we could not block that pathway enough to give him long term protection. He ruptured and died. Here's another patient where there was a little aneurysm of the arch just proximal to the top end of our repair. Four years later, that's a big aneurysm
proximal to our repair. Big enough that it's creating an endoleak and again, try as we might, we could not fix that. Partly because his ascending thoracic aorta was diseased. Here's another proximal common failure where a vessel remote from the repair has dilated.
In this case, the subclavian is a little more amenable to treatment. Here, a type three endoleak. The guilty party was the spicule of bone projecting into the aneurysm. And here you can see how flexible stent grafts
can be stable, surprisingly stable. And, we have not seen any disconnections in all of this experience. But there are some unsolved issues and I would have to say, that in the short term, the most dreaded complication is paraplegia, in the long term,
it has been renal branch occlusion. So, why would a straight, unkinked renal artery branch occlude, while the contralateral side which is going through a very tortuous path, remains patent? Well, the answer is, what the straight graft, straight renal branch does
to the bent mobile renal artery, whereas the more conformable branch leaves that in a much more natural configuration. But here are our data on branch artery occlusion. And this shows the rate with the stiff branches. This shows the rate with the flexible branches.
I think the days of frequent branch artery occlusion are actually over. What about the contraindications? There are a lot of anatomic requirements and anatomic obstacles that can make the repair impossible. But, if you look at them one by one,
most of them are immutable to some sort of proprietary repair, at the top end, at the bottom end, sorry here at the top end. Branch stenosis, this is actually the commonest of the staging operations that we perform.
Luminal compartmentalization in cases of dissection. Renal arteries that are too small, that are duplicated. Or renals that have very poor baseline function. Of all of those, these are the ones that are very difficult to treat. And if we have to exclude any patients, they are patients
with those features. So, there's a lot of anatomic obstacles. You can overcome most of them. The commonest short-term failure mode to date, has been lower extremity weakness. I think you'll hear from my colleague, Dr. Hiramoto,
why that, you could say with confidence, is really not the case anymore. The commonest late failure mode related to occlusion of the renal branches. Again, I think that may be a thing of the past. I sincerely hope so.
And the surprise of it all in this 17 year experience, is that the multi-branched, multi-component stent grafts that we were using, proved to be remarkably stable. Thank you.
- Thanks Sam and obviously thank you Dr. Veith and the group for the invitation to participate. These are my disclosures. Aortic arch pathologies vary and are similar to many of the ones that we treat in the rest of the thoracic aortic including: aneurysms,
penetrating ulcers, and complex aortic dissections. As well as some thoracoabdominal aneurysms that may extent in the aortic arch, making the procedures more complicated. As we go farther into the aortic,
both open and in the vascular procedures tend to be more difficult, more complicated, and associated with a higher complication rate. But open repair up to now, has continued to be the gold standard for the management
of many of the patients that have aortic arch disease. Because of the high risk of many of the patients and the increase utilization in the vascular technique, hybrid procedures continue to be developed and continue to be used for the management of these patients in a variety of combinations.
The use a branched devices for the management of patients that have arch disease, have been considered since the 1990's. But at the time some of the procedures that were attempted were associated with significant complications,
especially cerebral vascular complications. And then the concept of using a single branch device was developed, with additional extr atomic reconstructions, to try to limit some of those complications. Well in the United States currently,
there are multiple single branched devices that are undergoing evaluation and prospected trials. And some of the double branched devices, like the cook device, are being used in selective PSID's in the united states. Currently,
the Terumo double branch device, for the treatment of aortic arch disease, is the only multi branch device that is on their trials in the united states. This device is based on the the Relay NBS Plus platform. It's an off-the-shelf device that
in patients with a complex anatomy can be customized to be able to accommodate that anatomy. It has a large single window for ease of cannulation of the two internal tunnels that are usually used to cannulate and branch innominate of the left common carotid arteries.
And the devices intended for Zone 0 deployment combined with a variety of reconstructions, if necessary, depending on the patients anatomy. It leverages some of the patented proximal capture technology.
As well as improved our configuration and prevention of retroflex deployment of thoracic devices in these challenging anatomies. As a self-orienting pre-curved Nitinol guidewire lumen and additionally a dual sheath that is very helpful and designed to facilitate advancement into zone 0.
Currently, there's an early feasibility trial that is being conducted in the united state, for the management of thoracic aortic pahtologies requiring treatment proximal to the origin of the Innominate artery.
It's a prospective, multicenter, non-blinded, and non-randomized study. Which the goal of enrolling around 10 patients in this particular trial.
Six patients have been successfully treated with the first one being enrolled in January 2018. Two more patients are scheduled to be done in December, and hopefully we will finish this portion of the trial over the next few months.
There are for sites in the United States that are currently participating in this trial. When we look at some of the data that's currently available, this is all preliminary since the oldest patient in the trial has around nine months follow-up. Four patients were treated with Aneurysmal disease.
One patient with a dissection, and one patient an enlarging and symptomatic penetrating ulcer. At the time, 100 percent of the patients had technical success. And with a mean follow up with approximately four months,
very early follow-up in this group there have been no periprocedural or moralities, no major endoleaks, and no branch occlusions. There were a number of complications that happened
to this complex group of patients. The vast majority of them having resolved over the follow-up. And to note, the last two patients did have a neurological deficit that occurred, but most of these patients had atrial fibrillation,
chronic, and they were an anticoagulation. The first patient that had a neurological deficit occurred after patients discharge. It was minimally symptomatic, and the patient has completely resolved
within a day or two of the event. The second patient that had a neurological deficit this was noted around two to three days after the procedure was performed. The patient has partially recovered and has been discharged for the hospital
and is on close continued follow-up. This is the patient that was treated with a dissection with a complex aortic problem, and the device deployed very nicely in this complex anatomy, and the patient has continued to do well. So in conclusion,
This aortic arch multi branch device is the first on trials in the United states. The early feasibility experience has been highly encouraging. And the device tracks very well, self-aligns in the arch with minimal manipulation,
and deploys accurately. Based on the longer European experience and these early results, an international pivotal to study is under development. Thank you.
- [Dr. El Sayed] Thank you very much, Mrs. Chairman, and thank you, Dr. Veith, for allowing us to present on the subject, here. I have no disclosures related to the subject. We all know that the great saphenous vein is the best conduit for peripheral bypass grafting, with a good five year patency
approaching the 80 percent range, and the native AV fistulas are the best AV access for patients with end stage renal disease. However, there are times when we have to use the less patency of a PTFE graft, in cases where we do not have native veins
that we can use for either procedures. This is the pattern of failure usually of a prosthetic graft, where we have a distal anastomosis having a neo-intimal hyperplasia at the toe, at the heel, and at the bed.
We think, we did this study, in vitro study, using CFD, looking at the pattern of flow at a end-to-side anastomosis, and you can see, there is a lot of turbulence there, and if you look at those flow maps, you will see there is a lot of lateral wall forces at the anastomosis, as well as low wall shear stresses.
And if you look at these areas, they actually correspond to the areas of the neo-intimal hyperplasia leading to failure of the graft. So the conclusion was that prosthetic graft's failure is a normal tissue response to an abnormal flow environment, and that endothelial cells at the anastomosis
are sensitive to the non laminar flow environments, including turbulence, stagnation, and so forth, and these cells will respond by signaling neo-intimal hyperplasia, thus promoting graft failure. How about in our body?
How does the flow pattern appear in our arteries? So we all learned in medical school that the flow pattern in our arteries is a laminar flow, but in fact, it's not a straight laminar flow, it's a spiral laminar flow, as first described back in 1991.
Ever since, the spiral laminar flow has been found to be present in the arch of the aorta, in the descending thoracic aorta, and even in medium sized vessels. This is a recent study looking at the infrarenal aorta, as well as the femoral arteries and the carotid arteries,
and you can see up to 90 percent of normal subjects, the type of flow in these vessels is spiral and laminar flow. That led to the invention of this type of graft, which is a spiral flow graft. Essentially, it's a normal PTFE usual graft
that has a spiral flow inducer at the distal anastomosis, near the distal anastomosis, and that will create a spiral flow at the anastomotic area. We have two types of grafts, one of them is for the AV access, and one is for peripheral grafts,
and I do believe that there is another company now that's going to take over this type of graft, and they will call it, I think the avatar graft. So this is the clinical evidence that we have nowadays, regarding the use of those grafts. Most of the peripheral bypass graft series
were done in Europe, and you can see that the five year cumulative patency is up to 62 percent, and that looks like about 30 percent improved one year primary patency, in comparison with standard PTFE. In the AV graft arena, you can see
there are two other series that show that the patency of the spiral flow graft is about 20 percent better, both in primary and secondary patency rates. Of course, those numbers are low, but they are significantly better than the regular PTFE,
and even Heparin bonded grafts. In conclusion, spiral flow grafts are a valid and successful option for peripheral bypass, and AV access surgery. The results are encouraging, and tend to be better compared to standard PTFE,
and this may be explained on the basis of improved hemodynamics created by the spiral laminar flow. Future direction, we think we need to have a registry of using this graft on a larger scale, to see how really they perform, and we also need the lab evidence
that this type of spiral flow really reduces the instance of the neo-intimal hyperplasia. And if this concept is really true, this might be used to extend the development of vascular devices, including stents, balloons, and even atherectomy devices, that would maintain
or recreate the spiral flow pattern in diseased vessels. Thank you very much.
- [Dr. Walker] Thank you Dr. Veith for the privilege of invitation. These are my disclosures. Obviously, I think in order to understand how we should treat this, it's really important to understand, what is in-stent restenosis in it's usual form.
And restenosis is usually, secondary to in-growth in a fully expanded stent, and reocclusion typically means there's superimposed thrombus. Now, several investigators of course have noted that when there are extensive stent fractures, patency is much worse.
Now, infrequently, in-stent restenosis is secondary to an under-expanded stent, and this is a real problem for interventional treatment. And historically, treatment of long, diffuse disease and occlusions within stents with angioplasty alone, has resulted in incredibly poor patency.
What is the rationale of this therapy? Well, to start with, suboptimal balloon results are common. Why is that? Well, when we dilate these vessels, we're squeezing water from the aqueous extra-cellular matrix. However, if we look at this simply one hour later,
it has reabsorbed most of that water. We've not removed the tissue. Secondly, we may embolize the thrombotic material. Thirdly, and something often overlooked, is this is within a fully expanded Nitinol stent. The martenetic properties of that stent may allow it
to acutely be stretched, but over time it is going to come back to its set size so there is no chance of positive remodeling. Now, what about putting stents inside of a stent? There's standard stents, that's a problem as well. These may continue to embolize,
there's no barrier to intimal ingrowth and the lumen is compromised even with a perfect result by at least that stent strut thickness. Obviously, mechanical stabilization of severely fractured stents with either covered stents or another form of Nitinol stent is probably crucial
and we must be able to fully expand the stents. There are presently three FDA approved therapies for in-stent restenosis that may be used alone or in conjunction with each other to improve upon the results that we've seen with angioplasty. These include Excimer Laser, Gore Viabahn,
and drug-coated balloons. We have to consider many things when we treat in-stent restenosis, and these are some of those. In some cases we should consider distal protection. So, what are these new therapies? Well, Excimer Laser is one.
I was lucky enough to have been one of the principal investigators in the Excite trial. The concept here is that laser would be used to remove the intimal hyperplasia and thrombotic material. And it could do that, hopefully, without injuring the stents.
We found very clearly, it did not injure stents. And it resulted in better safety and better efficacy than ballon angioplasty alone. And this was most manifest in long lesions. The longer the lesions, the greater the improvement. And here we can see typical examples.
On the left, severe in-stent restenosis. On the right, post laser. And balloon in another case. Now, another study, very important, was the Gore Viabahn Endoprosthesis for In-Stent Restenosis, or the RELINE study.
And we can see in this that the Viabahn stent placed for in-stent restenosis resulted in dramatically improved patency as compared with balloon angioplasty alone. And in fact, these results were similar to those seen in McQuade's study in the past
in which he showed that a prosthetic endo arterial bypass performed just as well all the way out to four years as an external bypass. Now, Medtronic's drug-coated balloon was reported... It's results were reported and based on this, again, we have approval for DCBs.
And then Gandini combined DCBs with laser and how did he do? This gave far better patency than laser plus balloon alone, and better patency than drug-coated balloon alone. So there's a new paradigm for ISR intervention. PTA is no longer the treatment of choice. Patency rates with these new therapies is better,
combination therapy seems to be promising by first cleaning out the stent and then relining or treating with a drug-coated balloon. Patency rates are approaching that of PTF bypass when we use endoprostheses. I think sparing of the vein for future
below-the-knee bypass is prudent. Intervention is less invasive and can be repeated. And I believe, sincerely, these new interventions are the best way to treat femoral-popliteal in-stent restenosis. Thank you.
- [Jean-Marc] Thank you, ladies and gentleman. Thank you, Frank for the kind invitation. I will present our experience with the custom made proximal scallop on the basis, on the Bolton Relay and try to focus a little bit more on the value after ascending aortic repair. These are my disclosures.
So within the Bolton Relay graft I just, just before and the proximal scallop endografts are made on the basis of this stentgraft relay plus. It's with a proximal bare stent with capture and this graft is available within three weeks.
So no off the shelf device for the for the moment. It's the time to perform a proximal reinforced scallop with a median width of 20 millimeters in our experience and a median length of 30 millimeter. That is detectable by markers
that are easy to see and was in this presentation early in the morning. In order to be able to deploy the scallop at the level supra aortic trunk, the device is loaded on the Nitinol pre-curved inner catheter.
That allows tracking of, to the natural curvature of the arch. Enhances the alignment of the graft. And also allows a self-orientation of the scallop on the outer curvature of the arch. So there's no need to orientate the graft later on.
Of course there's no need to cross the valve either. Here's our experience since 2012 we're treating 26 patients. 13 sacciform, thoracic aneurysm, nine fusiform who had been treated by TEVAR earlier with type 1 A endoleak that could be solved and we will focus on this a little bit later
four chronic dissections, three having mechanical valves that was already repaired. We treated four patients in zone two and most of our experience was on 20 patients on zone one, two patients in zone zero. We have a mean follow-up of 30 month.
We had 100 percent of implantation success. 30 day mortality of three point eight percent. Two strokes which makes a rate of seven point seven. No paraplegia, eight cervical debranching. And during the follow-up all the targets supra aortic trunks are patent.
No type 1 A endoleak, and no retrograde dissection. So the advantages of this proximal scallop endografts are very useful to deal with short necks in the arch. Their deployment is precise and reproducible, it is really easy to deploy as a standard graft. It self-orientates in the arch.
It avoids debranching, chimney and branch procedures without cannulation in the arch, and no snaring of wires. There's no need also to cross the valve. Which makes for us, safe and efficient results with more than two years of follow-up.
So I would like to focus the value of these grafts after ascending aortic repair, especially when an hemi-arch has been perform in most of the cases that are treated right now of type A dissections. And especially when the valve has been
replaced and we'll see these, these cases all of us and we, they are very challenging for endovascular repair. Roselli proposed a simplified frozen elephant trunk for acute type one dissection, and he was proposing to make himself the
the scallop at the acute phase and put the graft in integrally, so this makes a very nice arch repair. But unfortunately many of the ascending aorta that are repaired are treated with only an hemi-arch that's probably why the patient is still alive. And what we propose and when you have
to come back later is to perform with the scallop graft a reverse endovascular hemi-arch repair. Of course there are still room for branch devices and especially when the valve has been change and you can cross it. Especially in very proximal lesions,
a branch device can be used and we, we've treated a few of these patients like this. But we believe that when the valve has been changed it can not be crossed and the, this graft has big advantage, you don't need to cross the valve to deploy and to address the
supra aortic trunk patency. You see the, the, the scallop aligns properly and then the graft just deploys just like a standard TEVAR with a tip capture and retrieval of the sheath. And after that we could have a, a nice completion.
You got your pre operative and the post operative at one year with a complete sealing of the proximal zone and also the distal zone is sealed by the stabilized technique we've talked about last on, on Tuesday. The complete repair of, of a challenging case.
We have some other cases like this. For example this huge false aneurysm on the distal part that could be treated also with the same technique and sealed with a replaced valve with a nice result in the longer. So we believe that this graft is a
has a great value in such cases especially when the valve has been repairs, replaced. Thank you very much for your attention.
- [Speaker] So there are a few key things to brain protection when you do total arch replacements. The first is use a subclavian artery for arterial inflow, flood the field with CO2 and get rid of all air in the aortic arch and in your grafts, and thirdly, keep the pump time as short as possible when you're doing these procedures.
So, our volume of aortic surgery has progressively increased over time, and of the ones that we're doing the thoracic aorta and arch about over 100 are done with circulatory arrest. This is from a slide from a study we did in Houston looking at circulatory arrest and the safe time for arrest,
and basically you're safe up to about 40 minutes with deep hypothermia and no protection, and then at 60 minutes, in green, it appears that the stroke rate goes down, but actually what that is, is the mortality rate goes up and so you're not able to assess the patients.
So, certainly, circulatory arrest time is important. One of the interesting papers written many years ago was this one by DeBakey, but in fact, Stanley Crawford used the subclavian artery for an LVAD support device, and here is the patient in the post-op period.
And that gave us the idea of using the right subclavian artery for inflow for total arch replacements. In a study we did of some 1300 patients at the Cleveland Clinic, the mortality rate increased by certain procedures,
in particular, longer procedures, and the overall stroke rate was 6.1%. But what we did find was that a subclavian side graft, versus the other approaches, had a significantly lower risk of stroke, and basically reduced the stroke rate by about 40%.
So that's why I advocate using a subclavian or auxiliary artery for inflow. We then, more recently, did a prospective randomized trial for total arch replacements in 121 patients with CO2 flooding et cetera, and we randomized the patient
to retrograde versus antegrade brain perfusion. The mortality rate was 0.8%, clinical stroke rate, 0.8%. But when we looked at our MRI studies, 15% had changes, there was neurological decline on neurocognitive testing in 18%, for an overall event rate of 24%
with no difference between retrograde and antegrade brain perfusion. The point being that, the more carefully you look for neurological injury, the more you'll see it. So here's the slides
as far as blinded imaging study evaluations which basically showed no difference between the two approaches, and very little change over time in the various areas. So we used to perfuse with a side graft on the elephant trunks, as shown here,
but now we use the subclavian artery for inflow, and then obviously we do a lot of patients with various stenting techniques, and we classified this a few years ago, and used the subclavian for inflow and a lot of these patients are done
with frozen elephant trunks. One thing that I would recommend to you if you are doing these type of operations, open, put side grafts to the aortic arch, this is a graft that we had developed specially for this, and then put the elephant trunk to the back of that.
That avoids the problem of kinking in the aortic arch. And here's just some patients with stent grafting with a frozen elephant trunk, particularly in acute dissections. And here's a patient who had initially stenting for gut ischemia and compression of the false lumen
with a stent put into the descending aorta and the SMA, and then we went ahead and did a elephant trunk in that stent, and then replaced the aortic arch, and at the same time did a reimplantation of the aortic root.
This patient actually happens to be a senior executive at one of the companies sponsoring this event, and he's fully recovered and has no after-effects. So those are some of the things that can be done, and as I point out, use the subclavian artery, flood the field with CO2, we use 10 liters per minute,
and keep that pump time as short as possible. Thank you very much for your attention.
- [Jan] Yeah, thank you very much. I would like to thank Frank for the opportunity to present these data and I do that on the behalf of the so called PLIANT study group. I have nothing to disclose with respect to this talk. The E-liac Stent Graft System is a nitinol stent graft with a polyester graft
that is preloaded in a system that you can see here and which is very flexible. These prospective international observational study would report on 45 patients from 11 centers and I would present to you today the 30 day results and it is intended to follow these patients
for at least three years and all the morphological data are being investigated by a core lab. And here you can see the different sites in Europe and the age of the patients were the standard age that you will see in this type of disease was a little bit more than 70 years old
and most of the patients were, of course, also males. They had the same type of risk factors that you normally see, so there was nothing unusual with respect to that. The access in the femoral artery was done with an open surgical technique
in most of the cases, whereas percutaneous technique was used in about 1/3. The implantation site was the right side in 28 of the 45 cases and 14 on the left side and in three cases there was a bilateral implantation
of an E-liac stent graft. The so called britching stents, the peripheral stents were in the majority of the cases. The JOTEC E-ventus stent graft, but also Advanta, Bard, and the Bentley systems were used. The distal landing area was in the majority
of the cases in the main trunk of the internal iliac artery, but in some cases, we went further into either the interior or the posterior branch. The stent graft system can be combined with several abdominal stent graft types,
but most of these stent graphs that we used in this series were from JOTEC with their first or older version of the E-vita and then the E-tegra which is the newer version. Technical success which is not only defined as placing the stent graph at the right place,
but also to get the seal was not achieved in every case and the reason for this was endoleak out of which three closed spontaneously but there were three type a type 1a endoleaks and they were all in the aortic side,
but there was one isolated E-liac stent graft that was a mismatch of the proximal landing zone. So, there was a 96% clinical success at 40 days with four successful reinterventions and all the internal iliac arteries were patent and there was one occlusion
of the external iliac artery which lead to 98% primary patency of the external iliac artery. So, in summary, Mr. Chairman, the E-liac is safe, IBD graft which is versatile and effective
and the problems that we encountered, they were all man driven. Thank you very much for your attention.
- Relevant disclosures are shown in this slide. So when we treat patients with Multi-Segment Disease, the more segments that are involved, the more complex the outcomes that we should expect, with regards to the patient comorbidities and the complexity of the operation. And this is made even more complex
when we add aortic dissection to the patient population. We know that a large proportion of patients who undergo Thoracic Endovascular Aortic Repair, require planned coverage of the left subclavian artery. And this also been demonstrated that it's an increase risk for stroke, spinal cord ischemia and other complications.
What are the options when we have to cover the left subclavian artery? Well we can just cover the artery, we no that. That's commonly performed in emergency situations. The current standard is to bypass or transpose the artery. Or provide a totally endovascular revascularization option
with some off-label use , such as In Situ or In Vitro Fenestration, Parallel Grafting or hopefully soon we will see and will have available branched graft devices. These devices are currently investigational and the focus today's talk will be this one,
the Valiant Mona Lisa Stent Graft System. Currently the main body device is available in diameters between thirty and forty-six millimeters and they are all fifteen centimeters long. The device is designed with flexible cuff, which mimics what we call the "volcano" on the main body.
It's a pivotal connection. And it's a two wire pre-loaded system with a main system wire and a wire through the left subclavian artery branch. And this has predominately been delivered with a through and through wire of
that left subclavian branch. The system is based on the valiant device with tip capture. The left subclavian artery branch is also unique to this system. It's a nitinol helical stent, with polyester fabric. It has a proximal flare,
which allows fixation in that volcano cone. Comes in three diameters and they're all the same length, forty millimeters, with a fifteen french profile. The delivery system, which is delivered from the groin, same access point as the main body device. We did complete the early feasibility study
with nine subjects at three sites. The goals were to validate the procedure, assess safety, and collect imaging data. We did publish that a couple of years ago. Here's a case demonstration. This was a sixty-nine year old female
with a descending thoracic aneurysm at five and a half centimeters. The patient's anatomy met the criteria. We selected a thirty-four millimeter diameter device, with a twelve millimeter branch. And we chose to extend this repair down to the celiac artery
in this patient. The pre-operative CT scan looks like this. The aneurysm looks bigger with thrombus in it of course, but that was the device we got around the corner of that arch to get our seal. Access is obtained both from the groin
and from the arm as is common with many TEVAR procedures. Here we have the device up in the aorta. There's our access from the arm. We had a separate puncture for a "pigtail". Once the device is in position, we "snare" the wire, we confirm that we don't have
any "wire wrap". You can see we went into a areal position to doubly confirm that. And then the device is expanded, and as it's on sheath, it does creep forward a bit. And we have capture with that through and through wire
and tension on that through and through wire, while we expand the rest of the device. And you can see that the volcano is aligned right underneath the left subclavian artery. There's markers there where there's two rings, the outer and the inner ring of that volcano.
Once the device is deployed with that through and through wire access, we deliver the branch into the left subclavian artery. This is a slow deployment, so that we align the flair within the volcano and that volcano is flexible. In some patients, it sort of sits right at the level of
the aorta, like you see in this patient. Sometimes it protrudes. It doesn't really matter, as long as the two things are mated together. There is some flexibility built in the system. In this particular patient,
we had a little leak, so we were able to balloon this as we would any others. For a TEVAR, we just balloon both devices at the same time. Completion Angiogram shown here and we had an excellent result with this patient at six months and at a year the aneurysm continued
to re-sorb. In that series, we had successful delivery and deployment of all the devices. The duration of the procedure has improved with time. Several of these patients required an extension. We are in the feasibility phase.
We've added additional centers and we continue to enroll patients. And one of the things that we've learned is that details about the association between branches and the disease are critical. And patient selection is critical.
And we will continue to complete enrollment for the feasibility and hopefully we will see the pivotal studies start soon. Thank you very much
- [Robyn] Thank you for asking me to speak. I have no disclosures. Subclavian artery aneurysms are quite rare, making up only 5% of all aneurysms. However, they do make up 50% of all supra-aortic aneurysms. They come in two locations, first, proximal, located in the chest, these are usually
degenerative in nature and they have other conditions, such as connective tissue disorders, fibromuscular dysplasia, and vasculitis associated with them. They also commonly have concomitant thoracic aortic aneurysms. The second type that we've been discussing this last talk
are distal aneurysms, which are usually related to arterial thoracic outlet. Patients may present asymptomatic. Symptoms include pain, which usually is consistent with rupture, upper extremity ischemia, including claudication, rest pain, Raynaud's, or
thromboemboli, or possibly, posterior circulation stroke. A physical examination should be focused on evidence of distal ischemia or concomitant aneurysms, and diagnostic evaluation is usually good with a CTA for both diagnosis, as well as surgical planning, and as
we discussed in the last talk, digital subtraction imaging is needed if there's evidence of distal ischemia. Traditionally, degenerative aneurysms were treated with open surgery, the right subclavian can be approached through a median sternotomy, with possible extension into a collar incision.
The left subclavian is approached through a left anterior thoracotomy. Once inside the chest, there's multiple ways to repair the subclavian artery. If only a subclavian artery is involved, a primary aneurysmorphy may be done
versus over-sewing the aortic stump and an extra anatomic bypass, however, often, the aorta is also involved, and this may require cardiopulmonary bypass, replacement of the aortic section, and possible debranching, or extra anatomic bypass.
From the area of endovascular surgery, we can now often repair these without having to enter the chest. This can be done with primary stenting if it's just a subclavian artery, however, proximal and distal landing zone
is required proximal to the take off of the vertival artery. If there's no proximal landing zone, or the aortic arch is also involved, a TEVAR can be done with either extra anatomic bypass, a subclavian snorkel, or now, using new branched endo devices.
Due to the rarity of disease, there's not much in the literature pertaining to outcomes of these aneurysms. This study from the time of open surgery looked at 27 patients that had innominate artery aneurysm repairs, and as I discussed, many of them have concomitant diseases, and vasculitis.
About half of them required aortic artery placement, as well, and outcomes were mainly based on how the patients presented. Those that presented with a rupture had an up to 50% mortality rate, while those that presented electively had only a 5% mortality rate.
From the era of endovascular surgery, the dupe group looked at 24 patients and had similar results, with 21% of the patients having a connective tissue disorder, and about half of the patients having concomitant aortic disease.
They were able to repair 64% with endovascular techniques, and had a similar mortality rate to that seen with open surgery of 5% for elective cases. Moving on to distal subclavian aneurysms, as our last speaker discussed, they are related to thoracic outlets, and therefore,
when repairing them, attention need to be paid to first relieving the arterial compression, then removing the source of embolism, and finally, restoring distal circulation. The best approach to relieve that compression is through supraclavicular incision.
This facilitates removal of the cervical rib and gives the best arterial exposure. An infraclavicular incision may also be needed to facilitate the distal anastomosis. Particularly about cervical ribs, in the population cervical ribs are quite rare,
occurring in only about 1% of the population. However, they are seen up to about 75% of the time in arterial thoracic outlet syndrome. The cervical rib originates from C7, and commonly has fibrous bands to the first rib that lie within the middle scalene,
which cases the compression on the subclavian artery. Therefore, both the cervical rib and the first rib need to be excised together. This is in comparison to an anomalous first rib. That originates from T1, and usually can be removed on its own.
Moving on to arterial interventions as our last speaker stated, again, once the rib is removed the artery is well exposed and a traditional aneurysmorphy can usually be done to fix the subclavian artery, taking care to deal with any distal embolization
with embolectomy at the time. Looking at outcomes, our moderator, Doctor Thompson, looked at 40 patients that they did at their group, and showed that it was about 50% of the patients presented with upper extremity ischemia,
5% presented with a posterior stroke, 75% had a cervical rib, and 12% had an anomalous first rib. They had to manage 70% of patients with their subclavian artery reconstruction, which all had good long term patency. In conclusion, proximal subclavian aneurysms
are degenerative in nature, while distal subclavian aneurysms are related to thoracic outlet syndrome. Management of proximal aneurysms is complex and commonly involves repair of concomitant arch pathology, while management of distal aneurysms must include a thorough evaluation and treatment of the thoracic outlet.
Given the rarity of the disease and the multitude of treatment options, literature regarding outcomes is yet to be well defined. Form the current literature, it does appear repair can be done from either an endovascular, open, or hybrid approach. Thank you.
- [Lecturer] These are my disclosures. I'm sure you're all familiar with the Zilver PTX Drug-Eluting Stent nitinol stent platform with a paclitaxel coating. It's been the subject of a robust clinical trial program around the world. The largest experience coming from the Japan PMS trial
with over 900 patients. I'm going to share with you what I think are some interesting subgroup analysis in cohorts of patients that traditionally have thought to be high-risk for restenosis. One of those is long lesions,
again the trial in the US was over PTX was in short lesions less than 14 centimeters, but in more complicated real world lesions, how does it perform? This is the analysis from the randomized clinical trial in the US looking at lesions greater than 10 centimeters
versus those less than 10 centimeters, and you can see no difference in the results. And you compare that to treatment of lesions greater than 10 centimeters with PTA or bare metal stent in there's a significant difference. But looking at Japan which had absolutely the most
complicated real world lesions as you can see here going across this spectrum of the trials in the clinical program and increasingly complex portfolio of features, the lesion lengths in Japan PMS had a mean segment of 14.7 centimeters.
Looking at Freedom from TLR you can see that there's no difference between the outcomes in Japan and with the more complex lesions compared to those in the randomized clinical trial in the single arm study. Likewise with patency,
the primary patency rate is consistent across these studies. So it appears to sort of fly in the face of what we usually think about a difference in lesion length as a determinant of restenosis. What about diabetic patients, looking at those three groups, this is again from the randomized clinical trial,
no difference between diabetes and non-diabetics. Looking in Japan where there was a diabetes rate that was 59% enrolled. We look at diabetics versus non-diabetics exclusively from this trial, you can see no difference in freedom from TLR.
And as we go forward looking at in-stent restenosis in Japan, In-stent restenotic lesions occurred in 19% of patients if we compare the groups between in-stent restenosis and non-in-stent restenosis, again nearly similar outcomes between
in-stent restenosis and non-in-stent restenosis. How about occlusions and stenoses. If we look at this in Japan, the length of occlusions was a mean of 19.7 with a overall group as 14.6, stenoses was 11, and you can see the distribution below.
And if we look at these four groups, this is sort of interesting, you can see that they're similar outcomes for patients with stenos lesions irrespective of the length and total occlusions less than 14,
but somewhat lower freedom from TLR for total occlusions greater than 14 centimeters, and I think this might be expected but it confirms our suspicions. How about in patients with no run-off, this is traditionally been a group
that has not been enrolled in most clinical trials, certainly approval trails, from the Japan PMS there were actually 54 patients with not a single continuous run-off vessel below the knee. Two year data in this comparing to those with a greater than one or greater run-off vessel,
there's no statistically significant differences between the groups, except that the critical limb ischemia was much higher in the no run-off group. Lesion length was similar. If we look at safety,
I think it's important to note that there were three amputations in the no run-off group, all occurred within two months of the initial procedure, but in all three cases, the Zilver PTX was patent at the time of amputation, most likely reflecting a more advanced stage of disease
and anticipated after two months, between two months and two years, there was not a single amputation in the no run-off group, and there was seven patients in the run-off group who had amputation. Freedom from TLR, you can see again basically no difference
between these two groups, likewise in patency, somewhat surprising finding. Finally in renal failure patients the results from the Japan PMS, there were 321 patients who had chronic renal failure defined as a GFR less than 60 mls per minute,
209 of these were subject to two year data review and when compared to those patients who did not have chronic renal failure you can see a higher instance of diabetes and pulmonary disease in the chronic renal failure group as suspected.
Higher rates of severe calcification and CLI in the chronic renal failure group. And in terms of safety there were really no differences in low rate of thrombosis. And the freedom from TLR and the patency were similar between these two groups,
those with renal failure and those without. So in conclusion there's a large amount of clinical evidence that's been accumulated ranging from controlled level one evidence to these large global real world experiences. In the four year Japan PMS
and five year randomized clinical data are positive and confirm long term benefits in a number of traditionally thought of high-risk cohorts of patients. Thank you.
- I try to dissect this convoluted title into two questions, basically, when is endovascular treatment of post coarctation aneurysm best, and when is an open surgical intervention required. A couple of years back in time, we looked at predictors
of aneurysmal formation in patients after surgical correction of coarctation, and we found essentially two predictors, which is previous surgical patch repair, and the age at the surgical repair, as predictors for the evolution of
a post coarctation aneurysm. In other words, these two predictors could actually become important for the selection of patient for open surgery. I come to this in a moment.
A year later, we could publish the feasibility of percutaneous endovascular repair of those post coarctation aneurysm, post surgical aneurysm, easily by a customized
or off the shelf stent graft. So that is basically accepted in the community, and reflected in guidelines, that basically come to the conclusion to the question, when is endovascular treatment
of post coarctation aneurysm best. In the case of a risk-benefit ratio high for open surgery, which is in case it's a redo surgery, of course, in presence of extensive collaterals, with a significantly increased bleeding risk,
adult patients above the age of 13.5 years, according to the statistical analysis, and when end to end anastomosis is not feasible, and of course, patients need to be suitable for an endovascular approach.
Patient preference may play a role, most recently, and of course, is conclusion of endo first should be executed in dedicated centers that have options to treat the patient even openly.
The second part of my title, or the second question is basically to the preferred use of open stents or covered stents, and in order to show our recent analysis on this, I had the privilege to compare
a group of patients from my previous institution that used self-expanding open stents, and with my current position in another place, that uses CP stents, or covered balloon expandable stent grafts
in the setting of coarctation as the first and only option. So we have no data from two different hospitals that show similar patient sets, a total of 52 in each group, that do not show any demographic differences
over a time of 10 years, collected over 10 years. Clinical presentation of comorbidities are essentially the same, so we're dealing with a comparable set of patients
and two different concepts of treating primary coarctation. The post interventional vascular events are also similar, no significant differences between the two concepts from two different sites,
with a trend towards more re-stenosis in the setting of ballon expandable stents being used as the first approach, but not significantly more. Even in hospital complications, comparing these two groups of 52 patients,
age didn't show any significant difference, with a trend for longer hospitalization in patients treated with the CP stent or covered stent. Maybe this is only a coincidental finding and a more cultural event
rather than medically driven. If you look at the outcome curves between both groups, with no mortality in either group, there is a similar shape of the Kaplan-Meier curves
over up to 90 months, with an interesting difference in the first post interventional phase, with three asymptomatic localized dissection in the balloon expandable stent graph group, however, no significant difference over time.
This next slide summarizes the ballon expandable procedure with the CP stent. After obtaining lumen and connection between this ectatic aorta, it was possible to stent the segment
with a covered CP stent very nicely. You see the result on the lower right corner. The other concept is a bare self expanding Nitinol stent placed first after recanalization of the coarctation and then potential post ballooning
to obtain an appropriate dimension and the lumen. In summary, comparing those two approaches and answering the question, when is an open operation still required, I think it's fair to say that in adult coarctation,
and endo approach should be chosen first, and bare, self-expanding Nitinol are relatively safe as a concept, and durable solution, without the risk of side branch obstruction, whereas covered ballon expandable CP stents
are also safe, and offer a durable solution, but have to respect the LSA anatomy. An open surgery I think should be reserved for infants and children younger than 13.5 years, only in view of an end-to-end anastomosis.
Thank you very much.
Hypersplenism and portal hypertension, which is basically parenchymal reduction. I'm gonna-- how many minutes do I have? 10 minutes? 10 minutes, okay. So this is the other one, which is,
you're not trying to exclude aneurysms, you're not trying to impede flow, you're actually trying to kill spleen. You're trying to reduce splenic volume. This is an end artery splenic artery embolization. Completely different technique.
Completely different inventory except the microcath. HyperSplenism is basically splenomegally with reduction of blood cells. We usually do it for thrombocytopenia but it also could be neutropenia, okay? Neutropenia is actually a double-edged sword.
Sometimes we can't embolize because the white blood cell is so low that it's a high infection rate, so they actually have to boost up the white blood cells for us before we actually do the embolization to try to reduce the risk of infection.
Okay, so even in really bad thrombocytopenia, and there's actually neutropenia, we would actually have to wait. The hemooncologist would actually give drugs to increase and boost immunity, increase the white counts, so we can actually embolize the spleen.
Ideally, old school, you have to embolize at least 60-75% of the spleen. So, old school IRs would actually go in and whack the spleen 70-80%, once and for all. So usually, there are two ways to do this. One way is to actually just go to the splenic artery
and spray the spleen with particles, whether it's gel foam, any form of particles, PVA, embospheres, whatever. Bland particles. And actually just spray the spleen and hope for the best, that 25% of it's still alive.
Okay and you do it, you know, you play it by ear. Embolize a little bit, watch, repeat it and such. That's kind of one way of doing it. And that's also the way that you would actually have to be forced to have to do it if you can't reach the splenic branches.
Another way is to actually take out the lower 70-80% of the spleen, sparing the upper pole, and you usually try to spare the upper pole, because that's the closest to the lung. If there's a lot of pain involved, and there is a lot of pain involved with a spleen,
if the pain is higher up in the upper pole, you get a lot of splinting, they don't take a deep breath in you get atelectasis, you get fever, you get fever along with post-embolization syndrome, which also gives you fever, and now you're kind of in the fog of fevers and is this post-embolization?
Is this atelectasis? Is this splinting, or is it the worst of your fears, which is the spleen is dead and it's liquefied and you're getting infection and an abcess. So what we try to do is minimize the pain with the splinting and the atelectasis by sparing the upper pole.
At least in theory. An interesting paper came out and they actually showed how much of the spleen they took out, and what the results were. So when you take out more than 70%, which is by the book, old school way of doing it,
which is the majority of the IRs that you work with are gonna be doing this. They're gonna be taking a whack of the spleen 70-80%, biting the bullet, and then seeing what happens. You get a 50% complication rate.
Complications could be pain, it could be fever, it could be liquefaction. But you get very good results with neutropenia. Okay? If you do 50-70% you still get pretty good results with lower complications.
If you embolize less than 50%, you get okay response but it's not durable. It's only for six months and you get no complications. So here's my school. Here's the new school. What we do is we actually reach that 75%
but we reach it through two to three sessions. We take it bit by bit. What we do is we do a first session, 25-30%, where we take a whack of the lower pole, not the upper pole, so we can bring them back again. Because if you give it to them at the top,
and they really hurt, they'll never come back. (laughs) So you make sure they come back, at least for another session. Okay, so you take the lower pole out first. Some people, and I'll show you an example,
they'll take the middle portion out first, and then they'll take the lower pole and the last top pole at the very end. But another way is take the lower pole, then you take the upper pole. And then if you need to do some more,
you take a part of the middle portion. Okay, and this is an example of a very large spleen. I'm just running it through for ya. Going for the lower branches, lower pole, to-- actually, sorry, we went for the middle portion first,
this is the example of the middle portion. Took that out. And this is kind of your post. After the first session. Second session we took out more. Which is the lower pole.
Third session, we went for the upper pole and we took out the upper pole. Then we did-- and I'll show you the results, and this is what you see. So first time, it's 100% baseline of the parenchyma, we took it down to 62% residual, 46% residual,
and after the third time we actually brought it down to 25%, no complications, no pain, they keep coming back after a month and a half, and they were very well stabilized. And this is actually the same patients with the results. Platelet counts go up as the splenic volume goes down.
We're taking it gradually, piecemeal, instead of taking just one bite at it originally. The same thing with portal hypertension. I don't have time to talk about portal hypertension, but it's the same kind of technique, the same kind of approach.
It is phased or staged and it's basically going after the parenchyma. Thank you very much. (audience applause)
- [Albeir] Hey, thanks so much, I'll be getting on to thank Dr. Veith for the kind invitation again this year. My talk, Mr. Chairman, ladies and gentlemen, will be about predicting a risk score model to see how can we minimize spinal cord ischemia and offer significant thoracic aortic surgery.
Nothing to disclose. We all know that spinal cord ischemia is one of the most dreaded outcomes after thoracic endovascular aneurysm repair. Still, the incidence of spinal cord ischemia is not well validated.
It varies between one as we heard in this morning talks, up to 15. We feel like in all, between eight to 10% it's average estimation for what we can quote to our patient after the surgery. Yet, not enough literature to explain or to predict
which patients may develop spinal cord ischemia after TEVAR. We ought to determine significant predictors of spinal cord ischemia after TEVAR, and also to develop pre-operative risk score model to be used and anticipate what can happen after these significant surgeries.
It's a retrospective study of all prospectively collected and maintained data from Virginia's quality initiative, in conjunction with SVS. Study was about three, four years. Stake was all the definitions according to the SVS PSO data. And we also examined the landing zones,
as we all know the slide, that's basically the most important two zones, again to focus on would be zone two, which is a little to the left subclavian and also zone six for the celiac artery. We sometimes mandate to cover some area in vascular
while we are doing our intervention, but also in light of there's some area better to be covered. Having said this, we used a logistic regression analysis to identify significant independent predictors of SCI, and after this we create a numeric point score of each risk factors by dividing the beta coefficient
of each variable by the common denominator. And we developed a risk score to stratify the point system to low, moderate, and high, and we use a receiver operator characteristic curve to analyze and to compare and to indicate the validity. 400 patients for this study.
Mean age was 65 years old. Majority male, 52 TEVAR performed either urgently or emergently, and 32 patients, which is about 8%, developed SCI temporary and about 3% developed SCI permanently after discharge.
This is the demographics, when we look to the demographics between congestive coronary artery disease or cerebrovascular disease. It was significant if you compare between no SCI group and SCI group. And if you look at the result here,
we found five predictors, including covering subclavian celiac together, or celiac alone, trauma indication, cerebrovascular disease, and current smoker, all to be predictors of SCI after surgery.
We developed the risk score as you can see here between these five predictors, and we define the risk score to zero, which is low risk, medium one to three, and high more than four. And you can see the probability of SCI
if you use this score system, it's really significant. If you look to the people who are so high, a risk more than four point, the chance to have SCI after big thoracic surgery is up 16, 17%. This is very interesting,
because when you look to the ROC Curve, and we look to our original, the regression analysis, and the risk score we developed and also all the categories, all were identical and under the curve and this will indicate the validity of this risk score system.
Study has some limitation, it's a retrospective study. It's based on small sample, limited by data collected. Also a report about the lengths of stent or the extents of the coverage was limited in this data, except however I believe that our study can come to significant conclusion,
that SCI risk score model produced low or moderate or high risk categories, and knowledge of this can help when we talk to our patients and we estimate their risk of SCI after surgery. Our results, Mr. Chairman, ladies and gentlemen, suggest that celiac, dual coverage
of both subclavian and celiac or trauma indication or smoking or cerebrovascular accident can negatively impact the outcome of their TEVAR. Thank you so much.
- Here we go. Some of you may remember the ANCURE sheath with 27-French device, and now we're down to 14-French, with the Ovation and soon to be released, the INCRAFT from Cordis. Clearly there are some advantages of lower profile with easier delivery,
navigating tortuous vessel, and being able to treat the calcified vessels, hopefully with less iliac injuries, may be more applicable to women with safer and easier percutaneous access. Couple of examples.
A patient with 4.3 and 5.2 iliacs, before and after balloon angioplasty, and then the introduction of the Ovation device to be able to treat this patient. The tortuosity is illustrated in this particular case from Takao Ohki from Japan,
showing the navigation of an O of a 14-French OD device through very tortuous iliac arteries. This is a thoracic case with 5 millimeter external iliac arteries treated with the Zenith Alpha without conduits, and this is something that would not be feasible with the larger profile devices.
The need is not really huge but certainly it will help the patients that need adjuncts, as illustrated in about 9% of patients in this paper from Penn that was just released and probably avoid the iliac ruptures and the limb thrombosis.
It also may allow us to treat patients that are currently excluded such as women, illustrated by this review by Marc Schermerhorn from the Medicare database, showing that we still are excluding patients with women probably for iliac access. The question, is there a point of diminishing return?
And the answer is probably yes. A size less than 14- or 16-French is unlikely to increase the applicability of EVAR, reduce the complications further or simplify the procedure significantly. Now clearly there may be some disadvantages to lowering profile, and the question is,
whether it affects the outcomes and the durability? And some of you have seen many recent recalls and canceled projects and there's a distinct possibility that the push to reduce the profile may be interfering with some of the outcomes. These are multiple recalls and stopped trials
recently that may be related to the profile. So the question is, how is profile reduced? By clearly you have to reduce what you're packing in the delivery system, from the graft thickness and volume to using lower gauge Nitinol wires, smaller carrier, decreasing number of stents having a completely
different design for the graft. The first attempt at this, with the original Cordis device was an abject failure because it refused to do any kind of active fixation to the aorta. Now this does not always happen by interfering
with the implant, GORE was able to reduce the profile from 2- to 4-French. Simply by changing the constraining sheath around the endograft. The other changes in profile can come from either switching to a tri-body
modular instead of a Unibody, or having a completely different stent design, or switching from stainless steel to nitinol as was done with the Zenith LP, or trying to use a thinner Dacron fabric as was done with the Endurant Evo.
And occasionally that results in some failures that are not really intended. And probably, in most cases with low profile, there's some interference with the size of the iliac grafts that are implanted and may result in some disadvantaged limbs.
Clearly, there's a price to pay for aggressive attempts at reducing profile and this is a listing of some of the recent issues with attempts at reducing profile. With Endurant evo, the project was terminated because of fracture. InCraft is still not approved by the FDA for problems
with facture, but it has just receive an FDA panel approval, and hopefully is expected soon. The Zenith LP was held because of limb issues. The Zenith Alpha small sizes in the thoracic aorta have been removed because of thrombotic complications. And the Endologix AFX was recalled because of fabric holes.
And the Ovation biopolymer has shown some leaks with the anaphylaxis. So in summary, low profile devices are already here and devices between less than 18-French are now almost normal, most benefit from this especially in TEVAR but clearly we may have some
price to pay for the attempts at lower profile. Thank you.
- [Speaker] Thank you Mr. Chairman and thank you again to Dr Veith for this opportunity to be able to participate in this wonderful conference. So, over the next 4 minutes we'll update you on the status of the Bolton Relay Endograft as it is appropriate for use here in the United States. These are my ongoing disclosures
all related to clinical research and the area of thoracic and abdominal aortic disease. Those of you who are familiar with the Bolton Relay System realize there are some unique aspects of it which I think makes it very user friendly. The dual sheath concept, putting a larger rigid sheath
in the infrarenal abdominal aorta and then a PTFE sheath which allows you to potentially track through very tortuous anatomy, I think is a distinct advantage, in tortuous question shaped aortas. There is a pre-curved nitinol inner cannula
which was an improvement in the pivotal trial, which significantly improved deliverability, and I think decreased the risk of stroke and other neuro-embolic events. And then there are some specific things about the design of the Relay Graft in particular,
there's a very low tension proximal bear spring that does allow for good proximal apposition. There's a differential in terms of the strength of the springs along the graft, in terms having a very high proximal seal and fixation and then good distal seal as well.
I think the other unique thing about this graft, is beside the fact that it does have the usual wide range between 22 and 46 millimeters, it also comes in tapered configurations which I think is very useful for us here in the United States.
These are the pivotal studies related to the Relay Device. Myself and Dr Farve were investigators in the FDA phase to pivotal trial, the clinical trial, which reported the results on 133 patients. You can see there have also been other registries and trials that have been ongoing.
We'll focus on the Relay Plus, this was prospectively enrolled. I think its important to note that 95 out of these patients for the initial Relay System, the Relay Plus was in the last cohort, and that is actually where I think their better
results were obtained. We also had a concurrent surgical control both with prospective and retrospectively enrolled patients from several institutions. The key differences are a nitinol inner cannula, a hydrophilic coating on the outside of that sheath
and then a longer outer sheath which again I think improves deliverability in these patients. Here were the initial results at 30 days, with a very high primary clinical success. Significantly lower major adverse event rate again due to deliverability and the ability to put
the stent in system exactly where you want it. And also a significant decrease in overall stroke, no Type I endoleak, and Type III endoleak. We are fortunate that we do have five year follow up for this study now. And again, in the Relay Plus cohort there was
a very very low stroke rate over the entire five year period. Similarly in the Type I endoleak a very low rate over five years. I think its also important to note that mortality both for aneurysm related mortality
and for all cause mortality is very comparable to that seen for surgical controls. The other important concept is sac regression or sac shrinkage. And you can see out to five years there's a very high incidence of either no change
or overall significant decrease in the sac size with a relatively low rate of increase in sac size, presumably secondary to Type II endoleaks. So in summary, I think the Bolton Relay Thoracic Graft is safe and effective treatment for thoracic aneurysms. There were no aneurysm sac ruptures.
I think the low incidence of device related endoleaks and migration is laudable. And I certainly think improvements in their delivery system makes it a very intriguing device as we start going more proximally into the arch with their arch branch devices you've heard previously
presented by Dr Kuratani and some of our colleagues from Europe. And I do think this is well worth noting and moving forward. Thank you for your attention.
- [Frank] So, a little change in our tone here. Instead of how to do, I would like to remind all of us about two things that we seem to be increasingly forgetting, which is open surgery and no repair at all.
How about that? Here's a patient of mine that I follow or did follow for a number of years. He was a total train wreck medically speaking. A large aneurysm and getting larger, so he was getting increasingly concerned about it
and decided after a number of years, despite what I told him that he was quote unquote inoperable, either endo or surgically, to find somebody else and you know how it is.
If you try hard enough, no matter how borderline or pushy you may be, you will find somebody who would agree to do it. So, it was a very complex repair. He had a miserable two last days to his life. Eventually he ended up dead, of course.
This is just an anecdote, but it serves to underline one of the things that I'm talking about. It has been my observation and I'm sure it's not totally unique, that once these patients,
and I'm talking about mainly aneurysm patients, AAA and thoracic aneurysms, ends up in the hands of us. One of us is almost always an issue of how as opposed to whether to repair and we all know that each patient comes
in a context that is often complex in multi-factorial, particularly with this disease. So, injecting a dose of doubt and fear, I think it's quite healthy. No chance to the patients, but also for all of us as well.
Now, we are talking here about complex aneurysms and by that I mean something that cannot be treated optimally with either a standard EVAR and we all know what that is or a standard surgery,
which means an infrarenal clamp. So, that's fairly clear. Another aspect to this is something like what happened to this patient. A large complex aneurysm on a patient that was pretty healthy medically
and could have easily undergone open surgery, but he was treated in a center, in a place where everything is endo, and surgery's only an after thought, after a complication or something bad has happened. So, he ended up with a major type one endoleak,
a aneurysm 30 days later, complex ch-EVAR, but I must say, achieving a good result at six month CTA follow up, but one wonders, wouldn't he have been served better initially and particularly in terms of durability
with that well executed skill open surgery? Something else that I think we ought to keep in mind is that if we're going to really push the envelope and we love to do that. That's our middle name in the 21st century isn't it? We better be doing that for something
that is truly life threatening and that means a big aneurysm. I know we have been using parameters and guidelines that are essentially diameter based. I suspect that this is going to change, but perhaps not for a number of years,
but if we really look at some of the recent reports and especially for men and the risk of rupture and death within the next 12 months, which is the way to measure this, the risk is really extraordinarily low, under six centimeters.
In women however, the risk is three to four times higher. So we ought to be thinking about becoming a little less aggressive with men and far more aggressive with treating female aneurysms. There are good data on thoracic aneurysms, as you see there,
that if you are facing truly inoperable patient, where our medically colleagues have deemed the patient not to likely survive or tolerate a major open aortic operation, those patients, as represented down here, are not going to live very long,
regardless of what we do. So, we ought to take that into account as well. I know that all things are endo now. 80 to 90% of these patients, particularly in the AAA area, are being treated endovascularly,
and we all feel that this is a great thing and I think for the most part, it is, but not always, there are failures and we know about some of the long term difficulties that we are encountering. I think, most of us, would agree that today's EVAR results are clearly better but perhaps not perfect
and still many things remain to be known. So, I'll leave you with a couple of simple thoughts, guiding principles if you will. Always ought to weight the risks of the procedures versus the natural history of the untreated aneurysm. Seems very basic, right?
But I'm not sure if that's always present in our thinking. Elected repair of complex anatomy aneurysms requiring therefor complex procedures ought to be reserved for aneurysms in men that are six centimeters plus. Open repair still has much to offer,
especially for good-risk patients, and lastly, most truly inoperable patients should probably be left alone and not subjected to elective repair of any kind. Thanks very much.
- [Dr. Morasch] Thank you, Mark. And thank you, Dr. Veith, for another fine and kind invitation. I have nothing to disclose. I do have an important acknowledgement to make. All of the techniques that I am going to describe here are just as they were taught to me when I was a fellow
20 years ago with Dr. Berguer. And many of the images in this talk come directly from his fine textbook, Surgery to the Arteries to the Head. Personal experience, 124 surgical subclavian reconstructions to date, mostly for pre-tevar indications
covering the subclavian artery with a device. Strong bias towards transposition over bypass. That said there are a few indications where bypass is probably the procedure that should be performed. Those would be patients with very proximal vertebral origin from the subclavian.
Patients with distal occlusive disease that extends out to the middle third of the subclavian artery. And patients with a prior LIMA to coronary reconstruction, where transposition would require clamping the mammary artery and thereby rendering the myocardium ischemic. Again, personal experience I will tell you that in the vast
majority of patients a transposition can be performed. And there are a number of reasons why I prefer transposition over bypass, and I'll go over a few of them here. First, a transposition procedure would be easier and faster than a bypass in most circumstances. It requires only a single anastomosis.
Also as Dr. Berguer discussed the durability of a transposition, virtually a 100% patency long term is really unparalleled anywhere in vascular surgery. Transposition avoids the use of prosthetic material. Here is a case of an infected carotid subclavian bypass.
Clearly a difficult challenge. And transposition avoids injury to the frenetic nerve or to the brachial plexus because the dissection for a transposition is well medial to any of these structures. And finally in the case of coverage of the subclavian artery with tevar transposition eliminates
the possibility of a retrograde type two endoleak or continued profusion of the false lumen and the subsequent need to obliterate the origin of the subclavian either with emboli or ligating the subclavian itself. Typical anatomy, you'll see here in the segment of the
vertebral to be transposed the subclavian artery lies in most patients immediately adjacent to the carotid artery. But even in patients where the subclavian is quite disparate from the carotid artery, as in this case, a young woman who had had a coarctation repair as a child. An important point to make is the
subclavian can still be transposed, because it's not about bringing the subclavian artery over to the carotid, but instead mobilizing a significant segment of the carotid so it can be mobilized and moved over to the subclavian. The incision for transposition is medial
over the two heads of the sternocleidomastoid muscle, and that's in contradistinction to a bypass procedure which is performed lateral to those muscles. The dissection for transposition is carried down between the carotid artery and the jugular vein as opposed to lateral to the jugular vein.
The vagus nerve is left over with the carotid artery in order to prevent any traction injury. The thoracic duct is identified, ligated, and divided, as is the vertebral vein. And the vertebral vein is a good marker for your position. The structures you're looking for will be sitting
right behind it. Here is an image showing the vessels all dissected out. And you can see in this picture how much carotid artery is mobilized in order to pull it over to the subclavian and how close the subclavian in this segment sits to the carotid artery.
The vessels are clamped, the subclavian artery divided proximal to the vertebral, over sewn and then an end to side anastomosis performing the back wall first. And this I what it should look like when completed. So in conclusion the subclavian artery is an important
artery and I believe flow to it should be preserved, certainly when coverage with tevar in any circumstance possible. With few exceptions transposition should be used over bypass. And finally the approach to the
subclavian artery is a medial one and some authors have described the same approach to bypass to use for transposition and that's not the right way to do it. The approach is medial. Thank you.
- [Gary] Dr. Oroyo, I appreciate it. Try to do this in five minutes. These are my disclosures. So DES versus DEB, leave nothing behind. I think Koen did a great job of showing you it's not very common. And by the end of this talk I'll show you
things are longer in Ohio. If you look at the impact primary patency through two years, you can see that for the long lesions you really don't have great results and we're really trying to get better results. If you look at bare-metal stents,
they have little role in the treatment of SFA beyond the nitinol woven stents. But if you look at that, both for short lesions you continue to have a decreased patency, and for long lesions you have a continued decreased patency with bare-metal stents.
And if we look at the really long lesions with drug-coated balloon you see similar patencies, 63.7% at one year plus the buffer for the followup studies. Now if you look at impact long lesions, just as Koen showed you, the provisional stent rate for lesions at over 20 centimeters is 40%.
That means you're already doing something drug and a bare-metal stent. So, the DCB data to date is for optimal angioplasty. Remember, if you had more than a 70% residual stenosis was taken out of the original trials. Did not include significant calcification.
Still doesn't. We talked about mild, moderate, and severe. We need to put in there dense because that is what we're treating as well. They didn't demonstrate a class effect. It does not address problematic lesions,
such as nobody's even talking about ostial SFA disease, when we know in every other vascular bed ostial disease has a higher recurrence rate. And so what is the DCB BMS paradigm for long lesions? Half. So drug-eluting stents actually have
the longest five year data with stable results, low fracture rates in varied populations including calcification. So when people talk about not stenting, why do they say that? We say, stent fracture.
We say difficult to treat restenosis. We say leave the surgical options. So keep those in mind by the end of the presentation. If you look at the DES five-year primary patency rate, with the most problematic duplex scanning, in other words, very sensitive,
you can see it's much better than the provisional BMS in angioplasty. And if you look at this, you have to ask yourself why in the United States are the vast majority of patients treated without drug-eluting technology?
It should be, it is a crime. If you look at the five-year patency rate it actually continues to increase the difference between a drug-eluting stent and our typical way of treating these patients out to five years. And as Dr. Gray showed even our now new polymer stents,
certainly have to wait for the randomized trial, are showing significant promise with very low TLR rates even up to 24 months. Zilver PTX has been looked at in Europe in the more generalized registry, which shows even in restenosis, in-stent restenosis,
very low TLR rates at 24 months. In Japan almost 1000 patients, average lesion length 14.7 centimeters, and I want you to remember that part of it, had excellent one year results with a TLR rate of 91%, primary patency 86.4.
We've shown and now is in publication, the fact that there's a 39% decrease in the relative plaque burden when you compare drug-eluting stents to bare-metal stents. And out of Europe, oh venous bypass is starting to be threatened.
These are the results of the ZILVERPASS at interim results. We're still waiting for this, probably next year, at (mumbles) LINC Where venous bypass is associated with more problems than using drug-eluting stents. Now in Ohio we looked at our first group of patients,
our first year and looked at what kind of patients we were treating. So we had 89 patients, and the real cutoff for us is 20 centimeters. Less than 20 centimeters is simple disease. More than 20 centimeters is big disease,
and if you look at the lesion length, the short lesion is 13.9 average. If you look at the longer than 20, a 33 centimeter average. Now these were limited to the 80 centimeter lengths of stent that are now better. But if you look at this what you see
is the results for the short lesions are very similar to Japan and all the other registries with really, really low TLRs at two years. However, when you do get to that full drug jacket, it's certainly a lot better than bare-metal stents. But it certainly parallels what we're seeing in ZILVERPASS.
So that we still have to get better results in these really long lesions. So stent fractures, low fracture rates in these studies. Difficult to treat restenosis, low and less plaque burden, so much simpler. Leave the surgical option,
only bad techniques takes away surgical options. High restenosis in long lesions, certainly right now it appears to be at least as good as bypass with a vein. Thank you very much.
- [Physician] Thank you very much. I'm going back to the SFA right now. It's an honor for me to present the data on behalf of the study group. We are talking about here, it's much more about PTA in those days of drug-coated balloons and how to best do PTA,
and what it's showing you on that slide here is that with PTA we have some limitations. We have torsional stress which might reside in dissections, we have radial stress which also might reside in dissections, and also longitudinal stress, again,
followed by dissections. Now, a device which might help here is the Chocolate balloon, which is a covered, or not totally covered, but the nitinol string
stretch around that balloon as you see on the left hand side, which allow the balloon to inflate in a controlled way, and to reduce the stress of that balloon to the vessel wall, then resulting in less dissections. Now this balloon was also coated with Paclitaxel
called the Chocolate Touch balloon. So the Chocolate Touch balloon had a dosage of three microgram per square millimeter on the surface. And this is the balloon on the right hand side. And the principle of using that balloon is,
compared to other drug-coated balloons, is that, theoretically, a vessel prep with predilatation with a nominal balloon is not mandatory, at least we didn't do that in the study. Now we did a study with the drug-coated version, the Chocolate Touch balloon in the so-called ENDURE study.
There was an above the knee and a below the knee trial with follow-up until 12 months. Now just going to show you the data from the SFA trial for sites in Germany. 70 lesions, 67 patients, four sites as I already said, and no predilatation was required, as I already said,
single or tandem de novo lesions, and addition, we had a BTK cohort. So, I'd like to point out that according baseline characteristics we didn't include Rutherford two patients, so most patients were Rutherford three or above,
and according the further risk factors, baseline factors, also there were a high proportion of patients with hypertension, tobacco use, and elevated cholesterol, all shown in that slide over here. But according the lesion characteristics, at baseline,
severe calcification was seen in 22% of the patients, total occlusions, that's quite high, 33% of the patients, lesion lengths around 7 centimeters. This is the slide which summarizes the effect, the acute effect of the device, and as you see, the acute effect was very nice.
According follow-up, we have seen a consistent better result in ABI and in Rutherford, and if we go to TLR, we had only four TLRs in those patients at six months, no additional patients at 12 months.
In all the patients, we did a follow-up duplex ultrasound at six months, a patency rate of around 80% were seen, dropped a little bit at one year, but still good patency rate with this special drug-coated balloon.
In the summary, with this combination therapy, we have seen a very good PTA result, with no predilatation mandatory, and also good patency rate at 12 months, and because the results were so promising, a U.S. study will be started soon
with more than 500 patients and a five year follow-up in a lot of sites, Boston, yes, and New York. Thank you very much.
- [Dr. Schmidt] Thank you very much and thanks to the organizers to invite me here again, it's a honor. So this is my conflict of interest slide. So it's difficult to compare stents to each other because we do not have comparative trials. If we put the results patency rates of our stents into the graph we see that for short lesions,
older generation, in general nitinol stents were actuall lesions, there's a lack of data. Zilver-PTX stent may be better, may be also for longer lesions,
but maybe also new generation nitinol stents are as good as the Zilver-PTX stent. For example, the Misago stent, the Pulsar Four French stent, the Complete stent, EPIC stent, the biomemetic stent,
and Eluvia Drug-Eluting stent also looks quite good, but you have to keep in mind, these are all tested in short lesions, and these are not the lesions where we see so many restenosis, and still there's quite the lack for long lesions.
What about another criteria, to maybe prefer one stent over the other stent? Fracture-rates, we have seen in older stents going up to a rate of 50%. New generation nitinol-stents seem to be much better, lower than 5%, I hear, the fracture rates,
but again you have to keep in mind, tested in short lesions, and short lesion stents usually never fracture. However, if it comes to longer lesions which are here treated with new generation nitinol-stents, some may be worse than the others
and I think it's worthwhile to keep an eye on this and maybe to prefer one over another in this regard. What about severe calcification? Maybe there's one stent which is better than the other. First we have to see that in all these studies with new generation nitinol-stents,
severe calcification was never an exclusion. So obviously all these stents work quite nicely in calcium, however, we have to also keep in mind that the definition of severe calcification was completely different from one study to the other.
Here, for example, in the resilient study, calcification on both sides was severe, but if this is severe, what is then this here? I think this is a completely different class of calcium, I don't think the standard nitinol-stents can work here, as you can see here,
there's an early re-occlusion after taking an extended nitinol-stent into calcification and it collapsed, of course. You think there is a stent which is capable to treat, to come along with severe calcium? The Supera-Stent in this case here,
with this collapsed stent, we relined this with the Supera-Stent, with actually a very good acute and mid-term outcome. The problem is that it's sometimes a little difficult to take the Supera in, especially in severely calcified lesions,
because the appropriate implantation depends on very complete and rigorous pre-dilatation. Here, for example, with another very successful pre-dilatation, this stent did not fully open and then we lose all the advantages
of the Supera-stent in the severe calcium. It can be very difficult, very painful for the patient, if you pre-dilate the lesion very properly, and therefore this technique we found very helpful in these kinds of lesions: just take a long needle down to the calcium,
nine centimeter, we give local anesthesia around the plaque, it really helps a lot, you can do it for several centimeters here, not over the whole length, and really these patients are completely pain-free if you use this technique here.
Of course, if you consequently pre-dilate severely calcified lesions, you may come very close to rupture, and there we found this technique here very helpful: first pave, and then maybe crack the lesions, so if you anticipate that with rigorous pre-dilatation,
the artery might rupture, you first take a Viabahn, and then we do this consequent pre-dilatation, and after, because Viabahn does not have the strength to overcome the recoil and calcified lesion, we relined this with the Supera-Stent,
we find very good results with this technique. Another problem with the Supera-Stent is the severe foreshortening, especially for the ostial mid, can be very difficult to anticipate where you actually land with this stent, not always it works that nicely, as here,
and Dr. Palena suggested therefore, a technique which might help to have the stent very precisely here at the origin of the SFA, while first taking the first Supera in just from retrograde, and this end of the Supera is always very easy and very precise to implant.
So if we take the results from the Supera-Stent here, into this graph, of course, again, we do not have comparative prospective trials, but it actually doesn't seem to be a mistake to use the Supera for short but also for long lesions. So to conclude, to favor one specific stent
is currently difficult to justify, except maybe for not infrequent subgroup, the severely calcified lesion. Unfortunately, especially in calcified lesions, the implantation of a Supera-stent can be challenging, and the techniques like local adventitial anesthesia, the PRESTO technique, and the pave-and-crack technique
can be very helpful. Thank you.
- [Speaker] Thank you Frank, great to be here, great meeting, that was a great presentation earlier. These are my disclosures. So every time we talk about chimney EVAR effectiveness, the reality here is we're talking about what makes it fail, and our last speakers, Professor Donas, highlighted that, and the primary issue here really is endoleaks,
and the reason we have a lot of endoleaks is because what we're trying to do is take a square hole and shove a round peg through it and we find ourselves to be ineffective. The primary reason for that also is because we take infrarenal aortic aneurysms with short necks
and try to make them pararenal and use chimneys, or we actually take thoracoabdominal aortic aneurysms and vice versa, try to treat them like infrarenal aortic aneurysms and neither process works, and many have tried to modify the chimney itself
and try to get better outcomes. Dave Minion has done a beautiful job in trying to illustrate some of this, which has been long published, and it works, but it works with many, many other adjunctive procedures, like coil embolizations and others that we have seen.
When I was a fellow with Dr. Frank Veith many years ago, we did a study in an ex-vivo model, looking at whether the behavior of all sealed endoleaks is the same of not, and what we really found is that the pressure reduction across thrombosed endoleaks
is directly proportional to the length and inversely proportional to the diameter of the endoleaks, hence that this data would have suggested, and it actually is something that pans out to be true as we have learned over the last 15 years, that thrombosis of longer channel
and smaller diameter endoleaks would result in greater pressure reduction, hence a more stable aneurysm and far less needs for further interventions. So an optimal strategy here would be to create long and narrow gutters
if one believes in using chimney EVARs. So here's a patient, thoracoabdominal aoritc aneurysm, it's really a type IV thoracoabdominal aortic aneurysm, celiac has stenosis, SMA, bilateral renal arteries are patent, we could've used three or four chimneys
in this particular case, but my preferred approach had been in the past is to use a conduit, but that too has evolved, and you can simply use brachial percutaneous approach, and what you're seeing here is simply an angiogram of the descending thoracic aorta.
In this particular case, the thing to do here, and the way I tend to do it, is to create an endovascular docking station. Here's the thoracic stent graph that is deployed within the descending thoracic aorta. Once that happens,
you can actually create chimneys that are long, 10, 15 centimeter long chimneys. Once you cannulate all visceral vessels, which are being done right here, the trick really to do is to place all chimneys in one position, anterior or posterior, and invariably,
if you do this maneuver that I'm about to show you, almost all chimneys will always be in the posterior aspect. So you're not competing multiple chimneys around a thoracic stent graft that's sitting in the thoracoabdominal aortic segment, rather what's happening is, if you form a pigtail catheter
and then advance that pigtail to reaccess from the femoral approach once all the chimneys are in place, invariably, the chimneys will go in the posterior direction, and then certainly you can bring in the bridging stent graft and deploy that,
and here's just that being done, and what you'll see here is a completion angiogram, and invariably, with these long chimneys, you don't tend to see endoleaks, and what you will see in the middle is how those chimneys are almost always posterior,
they sway from right to left, and any gutters that would be created automatically get shut off in the vast, vast majority of cases, and that's the completion angiogram. Now, of course, chimneys and periscopes can be placed
in many different directions depending on the aneurysm. In this particular case, once again, all the chimneys are aligned anteriorly, if you do these periscopes from below, and then certainly bridging stent grafts that could go in either direction.
In this particular case, the problem is not so much endoleaks, although we see them, the problem also is kinks within those chimneys, especially when three or four chimneys are going in retrograde fashion or they're periscopes, and in this particular case,
a very simple trick is to deploy an undersized cuff in the area in the para-aortic area, in the para-visceral aorta, where you will have a lot of stent/stent overlap and competing forces and then deploy the new stent graft from within that, and what this invariably does is
it constrains the stent graft at that location only, and that allows the competing forces to go away. So, ladies and gentlemen, in my humble opinion, I think these cases can be done very safely, very effectively with very simple maneuvers that make us treat thoracoabdominal aortic aneurysms
as they were thoracoabdominal aortic aneurysms and not try to treat, you know, those aneurysms as if they were infrarenal using one, two, three chimneys but rather just doing what we would do were we to do open surgical repair, which is clamp the descending thoracic aorta,
bypass all visceral vessels, and those grafts tend to stay open for a long, long time. Thank you very much.
- [Chris] Frank and Jim, thank you very much, and it's an honor to be here at Veith, and in this session to talk to you about low-profile endografts and how they may expand treatment options in poor iliac vessels and even bad necks as is the topic of this session. We know that access is a major determinant of the amenability of a patient to EVAR and that more of these
procedures are being done percutaneously without general anesthesia. Lower profile systems may increase the number of patients that we can treat and potentially reduce hospital costs and lengths of stay. The premise of the fast-track EVAR has been looked at, where
we move away from the traditional EVAR with cut-downs and general anesthesias and longer stays to the procedure being done more percutaneously without general anesthesia, no ICU stay and next-day discharge, which is our standard of care for most of 'em. This fast-track premise has been perspectively studied in
the LIFE registry. This was 250 patients which have already been completed and published most of them could complete the fast-track protocol. And what you see is a significant cost advantage to that, but more than 21,000 dollars per patient.
And as importantly, the procedure time, length of stay and 30 day resubmissions were significantly reduced compared to the traditional EVAR and the premier data, with significantly less major events and no ICU stays in addition to the cost savings. There's a newer device almost completed enrollment here in
the IDE trial, only requiring a 7 millimeter neck, with a low profile system and at 7 millimeters, this can be placed very accurately and aggressively to the renal arteries appropriate for this session. Now I'm going to show you three cases where this may be of particular benefit.
This is a gentlemen with a lot of comorbidities and rapidly expanding, symptomatic aneurysm and you'll see by the CT angiogram, not only did he have some juxtarenal angulation, but really severe iliac tortuosity. And you can see it's a fairly large neck right at the level of the lower-left renal artery and this is a
big expanding aneurysm. Here is that procedure, again you see the juxtarenal angulation and fairly large diameter neck at the renals. But more importantly you see absolutely, severely tortuous iliac vessels.
Again with the lower profile system 16 and 14 french sheaths can be advanced fairly easily. This is all after pre-closing. And just as importantly you can aggressively position so that you can see fabric being placed just at the renal artery, and then you can actually hold it in place as the
polymer rings form and conform to this angulated neck. And here's the completion angiograms that you can see are actually well-preserved and there's no endoleak. And the 30 day on that one year CT angiogram looks very good in terms of the iliacs and no endoleaks. Second case I was asked by a CT surgeon in our facility that
used to do these to come and help, he'd already done a cutdown on the right and was having trouble on the left ... And we worked together. Here you can a little bit of a reverse conical neck and small iliac vessels. This is the cutdown and even then the 12 and 14 french
dilators couldn't go very easily and so we had to change the initial plan which was we were going to require a 20 french sheath to the lower profile systems and again can aggressively deploy this to the reverse conical neck and complete the procedure fairly easily. And then finally, we often run into the scenario where we're
treating both the expanding aneurysmal disease and iliac obstructive disease. Here you can see common iliacs disease and a left external iliac CTO. Here's actually crossing this from the arm into the proximal common femoral artery.
And treating the external iliac vessel first with Nitinol stents. The initial plan was to go ahead and treat everything in the same setting and cover this with our endograft. Maybe not the greatest idea with the Nitinol stent going down as low as it did.
But we very carefully got access with road mapping and vascular ultrasound below that, and pre-close it. Although you can see here that with an 8 french sheath, with the new stent we lifted that up. So we changed plans and fixed that and then just did ... You can see the common iliac artery extends here,
and here. And then brought him back in two months to complete the EVAR procedure. Here we used a combination of road map and vascular ultrasound from micro-acupuncture access. And now, pre-closed and very carefully took a dilator
through the Nitinol stents, able to get the 12 french sheath systems up through the stents very carefully. 14 french sheath on the right, carefully through those stents and then able to complete the procedure very nicely. So in conclusions, I think there's a trend across the
spectrum of companies to move towards a lower profile EVAR systems. I think that these have the potential to increase the number of patients that we can treat. And both in terms of iliacs and maybe even neck and also reduce hospital costs on lengths of stays and
appropriate patients. Thank you very much.
- [Anthony] Good morning ladies and gentlemen. Frank thank you, again, for the privilege of being here. Sherif, that was a fascinating anecdote and a case, and I think it's a tribute to your technical expertise. However, I don't think we can generalize from that. I have no disclosures. We know by personal observations
and review of the literature that single center reports show the benefit of carotid patching, and registry data also show the benefit of patching in a statistically significant manner. Randomized trials, as already been discussed, have shown significant benefit from carotid patching,
and that benefit surfaces by reduced operative stroke rate, reduced operative stroke rate and a reduced recurrent stenosis. And as already been alluded to and specifically stated, Dacron patches, however, have shown much less benefit and an increased risk of infection.
But let's look at a systematic review which was performed by Bond and his colleagues and published in the journal Stroke. Almost 1200 patients with 1281 carotid endarterectomies, they were either patched or closed primarily. When you look at the data,
and I'm not going to show you large tables, but I'm going to show you the data that were generated from patch angioplasty was associated with a 67% reduction in operative stroke. And that's the endpoint we're trying to achieve, obviously, the avoidance of stroke with this operation.
60% reduction in stroke and death. 88% reduction in perioperative carotid occlusion. 87% reduction in recurrent stenosis over time. And a 46% reduction in stroke and death over the long-term. So there was long-term benefits, and you can see the P values for each of these endpoints.
And then that led to a Cochrane Review a number of years later, and that was also shown to you by Dr. Sultan. And what he did, and for those of you that read Cochrane Reviews, they do present the data, and then they present some qualitative statements.
And yes, studies are never the quality that they want when they're included in the Cochrane Review. But they reviewed 10 trials, almost 2000 patients, 2157 carotid endarterectomies. And a patch closure resulted in a 69% reduction in ipsilateral stroke.
82% reduction perioperative occlusions. And a 76% reduction in restenosis. And you can see the power of these observations as reflected in the P values. So those observations and those reports are six, seven years old.
Do we have anything that's contemporary? And yes, we do. Let's look at the CREST trial data and the subset of patients that had carotid endarterectomy. And an analysis of how that endarterectomy was closed was published in Stroke.
Specifically addressing, does patching affect the outcome of carotid endarterectomy? And when you look at the operative stroke rate, defined by stroke within 30 days of the operation, is there any question of the benefit of patching? Almost three times the risk of stroke
when patients were closed primarily. And that translated into a significant difference in stroke and death. Now what about four year outcomes? Well the difference, the significant difference in stroke is preserved at four years
when patients were patched, and that translates into a benefit of a reduction in stroke and death in patients who had carotid patching. Well what about restenosis because that's one of the main reasons why we patch also. Look at the difference in restenosis.
A three-fold, more than a three-fold difference in restenosis in those patients who had a carotid patch in this randomized trial. Now obviously, patients were not randomized to patching versus no patching, so this is an observational study. And then when you look at who patches and who doesn't,
in terms of specialty, vascular surgeons in CREST performed 65% of the operations, they patch 89% of the time. Thoracic surgeons patch 76% of the time, but neurosurgeons essentially don't patch. And the question is, is that reflected in operative stroke rates, and I rather suspect it is.
So patch closure should be routine for all carotid endarterectomies. It's associated with a significant reduction in operative stroke, occlusion, stroke and death, recurrent stenosis, and long-term outcomes. Thank you for your attention.
- [Armando] We're going to focus only the zone zero lesions. So, there's no disclosure. So, going to give a step-by-step how can I do the chimney sandwich technique in zone zero lesions and to avoid gutters and to avoid type one endoleak. Let's see this case, for example, that's a saccular aneurysm with a huge PAU,
that's penetrating ulcer hematoma as you can see here. And it's completely zone zero because it has this small curvature, just a ulcer. The first step that you try when you have proximal and distal neck, that's very important, as Mario already said about the diameter of this
in the aorta, you cannot do this with more than 38 millimeters in diameter. And if you have very distal length, this one good also. So, I can use a chimney beginning in the left subclavian artery so I can keep some flow in the brain.
So, my first step come from a break approach with a self-expandable covered stent. It's a Viabahn, one millimeters bigger than the lumen of the left subclavian artery. Come to the femoral over thoracic stent graft, and in this area just below the carotid artery.
So, the second step, I deploy the thoracic stent graft, keep the, as you can see here, the self-expandable covered stent to undeploy that. And, after that, as you can see here, I can deploy, I going to deploy this Viabahn here. It's almost impossible to see,
because they're very difficult to see there. So inside the self-expandable covered stent, I deploy a bare metal self-expandable stent here, so I can avoid kink and an occlusion of this Viabahn. And then I make sure that it's working, so that's going to, now I have with the vertebral artery, as you see here,
it's dominant vertebral artery, so it can keep now the brain with some flow. So the next step, I shoot the angio and see that a left subclavian periscope chimney, as you can see, it's working now. So I come now from the femoral of the second stent graft
and from axillary open access, Viabahn here in front, it open in the neck to approach the left carotid artery here. So we've two Viabahns here, one millimeters bigger than the lumen of these arteries. The next step, as you can see here,
I deploy the stent graft and keep the two self-expandable covered stents undeployed. The next step, I use a tri-lobe balloon. In all this overlapping, that's more important to have at least five or six millimeters overlapping and to avoid type one endoleak.
In this technique of this latex balloon, I can reduce a gap, a gutters, sorry, a gutters between the Viabahns and the covered stent. As you see here, all the covered stents still undeployed. And then the next step, I deploy both Viabahns, and that's the final result
with the left subclavian artery in the retrograde flow. And always use innominate artery and the left common carotid artery in antegrade flow. That's one week CAT scan, so you can see completely exclusion, no gutter at all, and here also.
Let's see how it works, always I do in this way. Two chimneys in the antegrade and one chimney in the retrograde flow. Try two. In our institution, we have 20 patients with zone zero, only zone zero, since 2010.
Our primary endpoints is 30 days, one year follow-up. The endoleak and supra-aortic trunk patency, as well the sac aneurysm evolution. Median follow-up is almost 20 months. Primary patency was 91%. Actually, this three is what should be subclavian artery,
two of them already came to me with previous occlusion of that. And only one have occlusion after the procedure. And 30 day endoleak was 20%, I have one type one, one type two, a type one with a proximal stent graft.
About late endoleak, 10%. Two patients, 30 day mortality was 90, the survival was 90% in 30 days, and we have four late death, one procedure-related, this patient has a previous aortoesophageal fistula,
and die after 4 months with pulmonary infection. In three others, non-procedure-related, with open repair of thoraco-abdominal aneurysm, and another one from MI, another one of lung cancer. And after 12 months, complete aneurysm sac exclusion 90% of the case.
No conversion rate, no spinal cord ischemia, and only one stroke rate. In conclusion, of course in this urgent setting, I think this techniques with parallel graft chimney with sandwich could be very useful for your patient.
Thank you very much for attention.
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