- Thank you very much and thank you Dr. Veith for the kind invite. Here's my disclosures, clearly relevant to this talk. So we know that after EVAR, it's around the 20% aortic complication rate after five years in treating type one and three Endoleaks prevents subsequent
secondary aortic rupture. Surveillance after EVAR is therefore mandatory. But it's possible that device-specific outcomes and surveillance protocols may improve the durability of EVAR over time. You're all familiar with this graph for 15 year results
in terms of re-intervention from the EVAR-1 trials. Whether you look at all cause and all re-interventions or life threatening re-interventions, at any time point, EVAR fares worse than open repair. But we know that the risk of re-intervention is different
in different patients. And if you combine pre-operative risk factors in terms of demographics and morphology, things are happening during the operations such as the use of adjuncts,
or having to treat intro-operative endoleak, and what happens to the aortic sac post-operatively, you can come up with a risk-prediction tool for how patients fare in the longer term. So the LEAR model was developed on the Engage Registry and validated on some post-market registries,
PAS, IDE, and the trials in France. And this gives a predictive risk model. Essentially, this combines patients into a low risk group that would have standard surveillance, and a higher risk group, that would have a surveillance plus
or enhanced surveillanced model. And you get individual patient-specific risk profiles. This is a patient with around a seven centimeter aneurysm at the time of repair that shows sac shrinkage over the first year and a half, post-operatively. And you can see that there's really a very low risk
of re-intervention out to five years. These little arrow bars up here. For a patient that has good pre-operative morphology and whose aneurysm shrinks out to a year, they're going to have a very low risk of re-intervention. This patient, conversely, had a smaller aneurysm,
but it grew from the time of the operation, and out to two and a half years, it's about a centimeter increase in the sac. And they're going to have a much higher risk of re-intervention and probably don't need the same level of surveillance as the first patient.
and probably need a much higher rate of surveillance. So not only can we have individualized predictors of risk for patients, but this is the regulatory aspect to it as well.
Multiple scenario testing can be undertaken. And these are improved not only with the pre-operative data, but as you've seen with one-year data, and this can tie in with IFU development and also for advising policy such as NICE, which you'll have heard a lot about during the conference.
So this is just one example. If you take a patient with a sixty-five millimeter aneurysm, eighteen millimeter iliac, and the suprarenal angle at sixty degrees. If you breach two or more of these factors in red, we have the pre-operative prediction.
Around 20% of cases will be in the high risk group. The high risk patients have about a 50-55% freedom from device for related problems at five years. And the low risk group, so if you don't breach those groups, 75% chance of freedom from intervention.
In the green, if you then add in a stent at one year, you can see that still around 20% of patients remain in the high risk group. But in the low risk group, you now have 85% of patients won't need a re-intervention at five years,
and less of a movement in the high risk group. So this can clearly inform IFU. And here you see the Kaplan-Meier curves, those same groups based pre-operatively, and at one year. In conclusion, LEAR can provide
a device specific estimation of EVAR outcome out to five years. It can be based on pre-operative variables alone by one year. Duplex surveillance helps predict risk. It's clearly of regulatory interest in the outcomes of EVAR.
And an E-portal is being developed for dissemination. Thank you very much.
- Thank you Professor Veith. Thank you for giving me the opportunity to present on behalf of my chief the results of the IRONGUARD 2 study. A study on the use of the C-Guard mesh covered stent in carotid artery stenting. The IRONGUARD 1 study performed in Italy,
enrolled 200 patients to the technical success of 100%. No major cardiovascular event. Those good results were maintained at one year followup, because we had no major neurologic adverse event, no stent thrombosis, and no external carotid occlusion. This is why we decided to continue to collect data
on this experience on the use of C-Guard stent in a new registry called the IRONGUARD 2. And up to August 2018, we recruited 342 patients in 15 Italian centers. Demographic of patients were a common demographic of at-risk carotid patients.
And 50 out of 342 patients were symptomatic, with 36 carotid with TIA and 14 with minor stroke. Stenosis percentage mean was 84%, and the high-risk carotid plaque composition was observed in 28% of patients, and respectively, the majority of patients presented
this homogenous composition. All aortic arch morphologies were enrolled into the study, as you can see here. And one third of enrolled patients presented significant supra-aortic vessel tortuosity. So this was no commerce registry.
Almost in all cases a transfemoral approach was chosen, while also brachial and transcervical approach were reported. And the Embolic Protection Device was used in 99.7% of patients, with a proximal occlusion device in 50 patients.
Pre-dilatation was used in 89 patients, and looking at results at 24 hours we reported five TIAs and one minor stroke, with a combined incidence rate of 1.75%. We had no myocardial infection, and no death. But we had two external carotid occlusion.
At one month, we had data available on 255 patients, with two additional neurological events, one more TIA and one more minor stroke, but we had no stent thrombosis. At one month, the cumulative results rate were a minor stroke rate of 0.58%,
and the TIA rate of 1.72%, with a cumulative neurological event rate of 2.33%. At one year, results were available on 57 patients, with one new major event, it was a myocardial infarction. And unfortunately, we had two deaths, one from suicide. To conclude, this is an ongoing trial with ongoing analysis,
and so we are still recruiting patients. I want to thank on behalf of my chief all the collaborators of this registry. I want to invite you to join us next May in Rome, thank you.
- [Speaker] Thank you. My disclosures. So upper extremity dvt occurs in 4-10% of all causes of venous thrombosis. And while a minority, dvt in the upper extremity can often be caused by thoracic outlet syndrome, effort thrombosis, occasionally
idiopathic venous thrombosis. The majority is more likely related to central venous catheters, pacemakers, cancer, etc. This is some of the presentation of someone with Paget Schroeder or venous thoracic outlet syndrome, we're all well aware of this.
Some features of this can be sudden onset of pain, discoloration and some of this subcutaneous collateral veins that we note. Initial treatment of this is traditionally with venous thrombolysis. Although the results are good, this thrombolysis can
be associated with bleeding complications, potential for renal insufficiency, prolonged dwell times, and increased cost. I think it's important that this is not just a talk about a technique but a technique in the context of an operation this is soon to come.
Whether you choose to take out the rib at the same setting or you choose to delay the operation by a week or two, by and large the complications associated with that venous thrombolysis are going to come back and haunt you in the next operations. I think that's the context of this talk.
One of the risks I just mentioned about some of these techniques is, that's sort of curious to me, is the acute kidney injury after AngioJet venous thrombolysis. You see here, this paper, of a hundred patients, 50 AngioJet, 50 catheter directed thrombolysis, shows a statistical significantly
increased risk of acute kidney failure in the AngioJet group. Eight fold odds ratio. The Indigo system enables operators to remove the thrombus in a single setting, while potentially reducing or eliminating the need for thrombolysis.
This has already been discussed by some of the prior speakers, you see the different iterations first introduced in 2014. The CAT8 is the largest device and you can see some of the features of this proprietary technology with the separator and the directional sheaths that
allow us to aspirate nicely. This continuous suction you see here, can be very nicely controlled with an on-off switch that minimizes blood loss. It's single operator design, very easy to set up, hands free aspiration, a very simple set up.
You also heard just recently about the volume that can be aspirated in 20 seconds you see, especially with the larger profile devices, quite impressive amount of thrombus can be removed. Again, with the careful control for blood loss. The directionality of the sheath is also important,
and you can see some of the different directionality sheaths. Here's a couple case examples of a Paget-Schroder patient comes in with an acute sudden onset of arm pain and swelling discoloration, and you can see the penumbra device being used to clean out that vein.
This is another example, a 25-year old male with acute right arm swelling, sort of a body lifter type, and you can see here, this is the separator that's being moved forward and backwards, in and out to help break out the thrombus. This is the CAT8 device.
The pre-intervention picture seen here, we're crossing the lesion with a wire and and you can see the post-intervention on the right. You, of course, have the venous compression from the first rib, thoracic outlet, but the vein is widely open and now we can go ahead and see
the specimen that's retrieved as you've seen other videos in the prior presentations. This, of course, is what we're left with at the time of surgery. I only bring this up to remind us that there is a second stage to this treatment,
which is the rib resection. A combined experience that I just want to put together, very small numbers of course but, 16 patients with thoracic outlet who presented and were treated with the Penumbra system. You can see here, some of the demographic data.
I'll just point out the symptoms, of course, pain, swelling in these patients, imaging mostly venous duplex, occasionally CT or MR venogram. They all of course get venography at the time of procedure. The extent of the thrombus in all of them was complete occlusion and you can see some
of the extent in the subclavian axillary veins. Site of access can be the brachial or the basilic vein. The operative details as well, shown here, and I'll just point out the estimated blood loss, it can be very reasonable, especially with some experience you can sort of control that
on-off valve and minimize blood loss with this technique. Adjunctive therapies are shown here and of course, maybe because we're a little bit stuck on our ways, we did have a fair number of adjunctive lytic therapy. There were only three patients who had overnight lysis. A lot of venoplasty done at the time of the procedure.
All veins remained patent until the day of the rib resection but I will point out that one of these patients did develop a significant complication with hemothorax. This is one of those patients who had overnight lysis. And I point that out to stress that perhaps
this is what we're trying to move away from. So, in conclusion, mechanicothrombectomy using Indigo device shows promising initial results. Minimal blood loss, one complication of the hemothroax with the overnight lytics. No renal insufficiency or distal embolization.
The practice pattern, I think, need to adjust away from routing lytics to additionally minimize complications prior to surgery. Thank you.
- Thank you and thanks again Frank for the kind invitation to be here another year. So there's several anatomic considerations for complex aortic repair. I wanted to choose between fenestrations or branches,
both with regards to that phenotype and the mating stent and we'll go into those. There are limitations to total endovascular approaches such as visceral anatomy, severe angulations,
and renal issues, as well as shaggy aortas where endo solutions are less favorable. This paper out of the Mayo Clinic showing that about 20% of the cases of thoracodynia aneurysms
non-suitable due to renal issues alone, and if we look at the subset that are then suitable, the anatomy of the renal arteries in this case obviously differs so they might be more or less suitable for branches
versus fenestration and the aneurysm extent proximally impacts that renal angle. So when do we use branches and when do we use fenestrations? Well, overall, it seems to be, to most people,
that branches are easier to use. They're easier to orient. There's more room for error. There's much more branch overlap securing those mating stents. But a branch device does require
more aortic coverage than a fenestrated equivalent. So if we extrapolate that to juxtarenal or pararenal repair a branched device will allow for much more proximal coverage
than in a fenestrated device which has, in this series from Dr. Chuter's group, shows that there is significant incidence of lower extremity weakness if you use an all-branch approach. And this was, of course, not biased
due to Crawford extent because the graft always looks the same. So does a target vessel anatomy and branch phenotype matter in of itself? Well of course, as we've discussed, the different anatomic situations
impact which type of branch or fenestration you use. Again going back to Tim Chuter's paper, and Tim who only used branches for all of the anatomical situations, there was a significant incidence of renal branch occlusion
during follow up in these cases. And this has been reproduced. This is from the Munster group showing that tortuosity is a significant factor, a predictive factor, for renal branch occlusion
after branched endovascular repair, and then repeated from Mario Stella's group showing that upward-facing renal arteries have immediate technical problems when using branches, and if you have the combination of downward and then upward facing
the long term outcome is impaired if you use a branched approach. And we know for the renals that using a fenestrated phenotype seems to improve the outcomes, and this has been shown in multiple trials
where fenestrations for renals do better than branches. So then moving away from the phenotype to the mating stent. Does the type of mating stent matter? In branch repairs we looked at this
from these five major European centers in about 500 patients to see if the type of mating stent used for branch phenotype grafts mattered. It was very difficult to evaluate and you can see in this rather busy graph
that there was a combination used of self-expanding and balloon expandable covered stents in these situations. And in fact almost 2/3 of the patients had combinations in their grafts, so combining balloon expandable covered stents
with self expanding stents, and vice versa, making these analyses very very difficult. But what we could replicate, of course, was the earlier findings that the event rates with using branches for celiac and SMA were very low,
whereas they were significant for left renal arteries and if you saw the last session then in similar situations after open repair, although this includes not only occlusions but re-interventions of course.
And we know when we use fenestrations that where we have wall contact that using covered stents is generally better than using bare stents which we started out with but the type of covered stent
also seems to matter and this might be due to the stiffness of the stent or how far it protrudes into the target vessel. There is a multitude of new bridging stents available for BEVAR and FEVAR: Covera, Viabahn, VBX, and Bentley plus,
and they all seem to have better flexibility, better profile, and better radial force so they're easier to use, but there's no long-term data evaluating these devices. The technical success rate is already quite high for all of these.
So this is a summary. We've talked using branches versus fenestration and often a combination to design the device to the specific patient anatomy is the best. So in summary,
always use covered stents even when you do fenestrated grafts. At present, mix and match seems to be beneficial both with regards to the phenotype and the mating stent. Short term results seem to be good.
Technical results good and reproducible but long term results are lacking and there is very limited comparative data. Thank you. (audience applauding)
- I'd like to thank Dr. Veith for this kind invitation and the committee as well. So these are my disclosures, there's none. So for a quick background regarding closure devices. Vascular closure devices have been around
for almost 20 years, various types. Manual compression in most studies have always been shown to be superior to vascular closure devices mainly because there's been no ideal device that's been innovated to be able
to handle all sorts of anatomies, which include calcified vessels, soft plaque, etc. So in this particular talk we wanted to look at to two particular devices. One is the Vascade vascular closure device
made by Cardiva and the other is the CELT arterial closure device made by Vasorum in Ireland. Both these devices are somewhat similar in that they both use a disc. The Vascade has a nitinol disc
as you can see here that's used out here to adhere to the interior common femoral artery wall. And then once tension is applied, a series of steps is involved to deploy the collagen plug
directly on to the artery which then allows it to expand over a period of time. The CELT is similar in that it also uses a stainless steel disc as you can see here. Requires tension up against the interior wall of the common femoral artery.
Nice and tight and then you screw on the top end of the device on to the interior wall of the artery creating a nice little cylinder that compresses both walls of artery. As far as comparability is concerned between the two devices you can see
here that they're both extravascular, one's nitinol, one's stainless steel. One uses a collagen material, the other uses an external clip in a spindle-type fashion. Both require about, anywhere between three to seven minutes of pressure
to essentially stop the tract ooze. But the key differences between the two devices, is the amount of time it takes for patients to ambulate. So the ambulation time is two hours roughly for Vascade, whereas for a CELT device
it's anywhere from being immediate off the table at the cath lab room to about 20 minutes. The data for Vascade was essentially showing the RESPECT trial which I'll summarize here, With 420 patients that was a randomized trial
to other manual compression or the device itself. The mean points of this is that the hemostasis time was about three minutes versus 21 minutes for manual compression. And time to ambulation was about 3.2 hours versus 5.7 hours.
No major complications were encountered. There were 1.1% of minor complications in the Vascade versus 7% in the manual compression arm. This was actually the first trial that showed that a actual closure devices
had better results than manual compression. The main limitations in the trial didn't involved complex femoral anatomy and renal insufficiency patients which were excluded. The CELT ACD trial involved 207 patients that were randomized to CELT or to manual
compression at five centers. Time to hemostasis was anywhere between zero minutes on average versus eight minutes in the manual compression arm. There was one complication assessed at 30 days and that was a distal embolization that occurred
early on after the deployment with a successfully retrieved percutaneously with a snare. So complication rate in this particular trial was 0.7% versus 0% for manual compression. So what are some pros and cons with the Vascade device?
Well you can see the list of pros there. The thing to keep in mind is that it is extravascular, it is absorbable, it's safe, low pain tolerance with this and the restick is definitely possible. As far as the cons are involved.
The conventional bedrest time is anywhere between two to three hours. It is a passive closure device and it can create some scarring when surgical exploration is necessary on surgical dissections.
The key thing also is you can not visualize the plug after deployment. The pros and cons of the CELT ACD device. You can see is the key is the instant definitive closure that's achieved with this particular device, especially in
calcified arteries as well. Very easy to visualize under fluoroscopy and ultrasound. It can be used in both antegrade and retrograde approaches. The key cons are that it's a permanent implant.
So it's like a star closed devised, little piece of stainless steel that sits behind. There's a small learning curve with the device. And of course there's a little bit of discomfort associated with the cinching under the (mumbles) tissue.
So we looked at our own experience with both devices at the Christie Clinic. We looked at Vascade with approximately 300 consecutive patients and we assessed their time to hemostasis, their time to ambulation,
and their time to discharge, as well as the device success and minor and major complications. And the key things to go over here is that the time to hemostasis was about 4.7 minutes for Vascade, at 2.1 hours for ambulation, and roughly an average
of 2.4 hours for discharge. The device success was 99.3% with a minor complication rate of .02% which we have four hematomas and two device failures requiring manual compression. The CELT ACD device we also similarly did
a non-randomized perspective single center trial assessing the same factors and assessing the patients at seven days. We had 400 consecutive patients enrolled. And you can see we did 232 retrograde. We did a little bit something different
with this one, we did we 168 antegrade but we also did direct punctures to the SFA both at the proximal and the mid-segments of the SFA. And the time to hemostasis in this particular situation was 3.8 minutes,
ambulation was 18.3 minutes, and discharge was at 38.4 minutes. We did have two minor complications. One of which was a mal-deployment of the device requiring manual compression. And the second one was a major complication
which was an embolization of the device immediately after deployment which was done successfully snared through an eighth front sheath. So in conclusion both devices are safe and effective and used for both
antegrade and retrograde access. They're definitely comparable when it comes, from the standpoint of both devices (mumbles) manual compression and they're definitely really cost effective in that they definitely do increase the
throughput in the cath lab allowing us to be able to move patients through our cath lab in a relatively quick fashion. Thank you for your attention.
- Thank you. I have two talks because Dr. Gaverde, I understand, is not well, so we- - [Man] Thank you very much. - We just merged the two talks. All right, it's a little joke. For today's talk we used fusion technology
to merge two talks on fusion technology. Hopefully the rest of the talk will be a little better than that. (laughs) I think we all know from doing endovascular aortic interventions
that you can be fooled by the 2D image and here's a real life view of how that can be an issue. I don't think I need to convince anyone in this room that 3D fusion imaging is essential for complex aortic work. Studies have clearly shown it decreases radiation,
it decreases fluoro time, and decreases contrast use, and I'll just point out that these data are derived from the standard mechanical based systems. And I'll be talking about a cloud-based system that's an alternative that has some advantages. So these traditional mechanical based 3D fusion images,
as I mentioned, do have some limitations. First of all, most of them require manual registration which can be cumbersome and time consuming. Think one big issue is the hardware based tracking system that they use. So they track the table rather than the patient
and certainly, as the table moves, and you move against the table, the patient is going to move relative to the table, and those images become unreliable. And then finally, the holy grail of all 3D fusion imaging is the distortion of pre-operative anatomy
by the wires and hardware that are introduced during the course of your procedure. And one thing I'd like to discuss is the possibility that deep machine learning might lead to a solution to these issues. How does 3D fusion, image-based 3D fusion work?
Well, you start, of course with your pre-operative CT dataset and then you create digitally reconstructed radiographs, which are derived from the pre-op CTA and these are images that resemble the fluoro image. And then tracking is done based on the identification
of two or more vertebral bodies and an automated algorithm matches the most appropriate DRR to the live fluoro image. Sounds like a lot of gobbledygook but let me explain how that works. So here is the AI machine learning,
matching what it recognizes as the vertebral bodies from the pre-operative CT scan to the fluoro image. And again, you get the CT plus the fluoro and then you can see the overlay with the green. And here's another version of that or view of that.
You can see the AI machine learning, identifying the vertebral bodies and then on your right you can see the fusion image. So just, once again, the AI recognizes the bony anatomy and it's going to register the CT with the fluoro image. It tracks the patient, not the table.
And the other thing that's really important is that it recognizes the postural change that the patient undergoes between the posture during the CT scan, versus the posture on the OR table usually, or often, under general anesthesia. And here is an image of the final overlay.
And you can see the visceral and renal arteries with orange circles to identify them. You can remove those, you can remove any of those if you like. This is the workflow. First thing you do is to upload the CT scan to the cloud.
Then, when you're ready to perform the procedure, that is downloaded onto the medical grade PC that's in your OR next to your fluoro screen, and as soon as you just step on the fluoro pedal, the CYDAR overlay appears next to your, or on top of your fluoro image,
next to your regular live fluoro image. And every time you move the table, the computer learning recognizes that the images change, and in a couple of seconds, it replaces with a new overlay based on the obliquity or table position that you have. There are some additional advantages
to cloud-based technology over mechanical technology. First of all, of course, or hardware type technology. Excuse me. You can upgrade it in real time as opposed to needing intermittent hardware upgrades. Works with any fluoro equipment, including a C-arm,
so you don't have to match your 3D imaging to the brand of your fluoro imaging. And there's enhanced accuracy compared to mechanical registration systems as imaging. So what are the clinical applications that this can be utilized for?
Fluoroscopy guided endovascular procedures in the lower thorax, abdomen, and pelvis, so that includes EVAR and FEVAR, mid distal TEVAR. At present, we do need two vertebral bodies and that does limit the use in TEVAR. And then angioplasty stenting and embolization
of common iliac, proximal external and proximal internal iliac artery. Anything where you can acquire a vertebral body image. So here, just a couple of examples of some additional non EVAR/FEVAR/TEVAR applications. This is, these are some cases
of internal iliac embolization, aortoiliac occlusion crossing, standard EVAR, complex EVAR. And I think then, that the final thing that I'd like to talk about is the use with C-arm, which is think is really, extremely important.
Has the potential to make a very big difference. All of us in our larger OR suites, know that we are short on hybrid availability, and yet it's difficult to get our institutions to build us another hybrid room. But if you could use a high quality 3D fusion imaging
with a high quality C-arm, you really expand your endovascular capability within the operating room in a much less expensive way. And then if you look at another set of circumstances where people don't have a hybrid room at all, but do want to be able to offer standard EVAR
to their patients, and perhaps maybe even basic FEVAR, if there is such a thing, and we could use good quality imaging to do that in the absence of an actual hybrid room. That would be extremely valuable to be able to extend good quality care
to patients in under-served areas. So I just was mentioning that we can use this and Tara Mastracci was talking yesterday about how happy she is with her new room where she has the use of CYDAR and an excellent C-arm and she feels that she is able to essentially run two rooms,
two hybrid rooms at once, using the full hybrid room and the C-arm hybrid room. Here's just one case of Dr. Goverde's. A vascular case that he did on a mobile C-arm with aortoiliac occlusive disease and he places kissing stents
using a CYDAR EV and a C-arm. And he used five mils of iodinated contrast. So let's talk about a little bit of data. This is out of Blain Demorell and Tara Mastrachi's group. And this is use of fusion technology in EVAR. And what they found was that the use of fusion imaging
reduced air kerma and DSA runs in standard EVAR. We also looked at our experience recently in EVAR and FEVAR and we compared our results. Pre-availability of image based fusion CT and post image based fusion CT. And just to clarify,
we did have the mechanical product that Phillip's offers, but we abandoned it after using it a half dozen times. So it's really no image fusion versus image fusion to be completely fair. We excluded patients that were urgent/emergent, parallel endographs, and IBEs.
And we looked at radiation exposure, contrast use, fluoro time, and procedure time. The demographics in the two groups were identical. We saw a statistically significant decrease in radiation dose using image based fusion CT. Statistically a significant reduction in fluoro time.
A reduction in contrast volume that looks significant, but was not. I'm guessing because of numbers. And a significantly different reduction in procedure time. So, in conclusion, image based 3D fusion CT decreases radiation exposure, fluoro time,
and procedure time. It does enable 3D overlays in all X-Ray sets, including mobile C-arm, expanding our capabilities for endovascular work. And image based 3D fusion CT has the potential to reduce costs
and improve clinical outcomes. Thank you.
- Yeah now, I'm talking about another kind of vessel preparation device, which is dedicated to prevent the occurrence of embolic events and with these complications. That's a very typical appearance of an occluded stent with appositional stent thrombosis up to the femur bifurcation.
If you treat such a lesion simply with balloon angioplasty, you will frequently see some embolic debris going downstream, residing in this total occlusion of the distal pocket heel artery as a result of an embolus, which is fixed at the bifurcation of
the anterior tibial and the tibial planar trunk, what you can see over here. So rates of macro embolization have been described as high as 38% after femoral popliteal angioplasty. It can be associated with limb loss.
There is a risk of limb loss may be higher in patients suffering from poor run-off and critical limb ischemia. There is a higher rate of embolization for in-stent restenosis, in particular, in occluded stents and chronic total occlusions.
There is a higher rate of cause and longer lesions. This is the Vanguard IEP system. It's an integrated balloon angioplasty and embolic protection device. You can see over here, the handle. There is a rotational knob, where you can,
a top knob where you can deploy, and recapture the filter. This is the balloon, which is coming into diameters and three different lengths. This is the filter, 60 millimeter in length. The pore size is 150 micron,
which is sufficient enough to capture relevant debris going downstream. The device is running over an 80,000 or 14,000 guide-wire. This is a short animation about how the device does work. It's basically like a traditional balloon.
So first of all, we have to cross the lesion with a guide-wire. After that, the device can be inserted. It's not necessary to pre-dilate the lesion due to the lower profile of the capture balloon. So first of all, the capture filter,
the filter is exposed to the vessel wall. Then you perform your pre-dilatation or your dilatation. You have to wait a couple of second until the full deflation of the balloon, and then you recapture the filter, and remove the embolic debris.
So when to use it? Well, at higher risk for embolization, I already mentioned, which kind of lesions are at risk and at higher risk of clinical consequences that should come if embolization will occur. Here visible thrombus, acute limb ischemia,
chronic total occlusion, ulceration and calcification, large plaque volume and in-stent reocclusion of course. The ENTRAP Study was just recently finished. Regarding enrollment, more than 100 patients had been enrolled. I will share with you now the results
of an interim analysis of the first 50 patients. It's a prospective multi-center, non-randomized single-arm study with 30-day safety, and acute performance follow-up. The objective was to provide post-market data in the European Union to provide support for FDA clearance.
This is the balloon as you have seen already. It's coming in five and six millimeter diameter, and in lengths of 80, 120 and 200 millimeters. This is now the primary safety end point at 30 days. 53 subjects had been enrolled. There was no event.
So the safety composite end point was reached in 100%. The device success was also 100%. So all those lesions that had been intended to be treated could be approached with the device. The device could be removed successfully. This is a case example with short lesion
of the distal SFA. This is the device in place. That's the result after intervention. That's the debris which was captured inside the filter. Some more case examples of more massive debris captured in the tip of the filter,
in particular, in longer distance total occlusions. Even if this is not a total occlusion, you may see later on that in this diffused long distance SFA lesion, significant debris was captured. Considering the size of this embolus,
if this would have been a patient under CLI conditions with a single runoff vessel, this would have potentially harmed the patient. Thank you very much.
- Thank you very much for the privilege of participating in this iconic symposium. I have no disclosures pertinent to this presentation. The Atelier percutaneous endovascular repair for ruptured abdominal aortic aneurysms is a natural evolution of procedural technique due to the success of fully percutaneous endovascular
aortic aneurysm repair in elective cases. This past year, we had the opportunity to publish our data with regard to 30 day outcomes between percutaneous ruptured aneurysm repairs and surgical cutdown repairs utilizing the American College of Surgeons NSQIP database,
which is a targeted database which enrolls about 800 hospitals in the United States, looking at both the univariate and multivariate analyses comparing preoperative demographics, operative-specific variables and postoperative outcomes. There were 502 patients who underwent
ruptured abdominal aortic aneurysms that were included in this review, 129 that underwent percutaneous repair, whereas 373 underwent cutdown repair. As you can see, the majority were still being done by cutdown.
Over the four years, however, there was a gradual increase in the number of patients that were having percutaneous repair used as their primary modality of access, and in fact a more recent stasis has shown to increase up to 50%,
and there certainly was a learning curve during this period of time. Looking at the baseline characteristics of patients with ruptured aneurysms undergoing both modalities, there was not statistically significant difference
with regard to these baseline characteristics. Likewise, with size of the aneurysms, both were of equal sizes. There was no differences with regard to rupture having hypotension, proximal or distal extension of the aneurysms.
What is interesting, however, that the patients that underwent percutaneous repair tended to have regional anesthesia as their anesthesia of choice, rather than that of having a general. Also there was for some unexplained reason
a more significant conversion to open procedures in the percutaneous group as compared to the cutdown group. Looking at adjusted 30-day outcomes for ruptured endovascular aneurysm repairs, when looking at the 30-day mortality,
the operative time, wound complications, hospital length of stay, that was not statistically significant. However, over that four year period of time, there tended to be decreased hospital length of stay as well as decreased wound complications
over four years. So the summary of this study shows that there was an increased use of fully percutaneous access for endovascular repairs for ruptured aneurysms with noninferiority compared to traditional open femoral cutdown approaches.
There is a trending advantage over conventional surgical exposure with decreased access-related complications, as well as decreased hospital length of stay. Now, I'm going to go through some of the technical tips, and this is really going to be focused upon
the trainees in the room, and also perhaps those clinicians who do not do percutaneous access at this time. What's important, I find, is that the utility of duplex ultrasonography, and this is critical to delineate the common
femoral artery access anatomy. And what's important to find is the common femoral artery between the inguinal ligament and this bifurcation to the profunda femoral and superficial femoral arteries. So this is your target area. Once this target area is found,
especially in those patients presenting with ruptured aneurysm, local anesthesia is preferred over general anesthesia with permissive hypotension. This is a critical point that once you use ultrasound, that you'd want to orient your probe to be
90 degrees to the target area and measure the distance between the skin and the top of that artery. Now if you hold that needle at equidistance to that same distance between the skin and the artery and angle that needle at 45 degrees,
this will then allow you to have the proper trajectory to hit the target absolutely where you're imaging the vessel, and this becomes important so you're not off site. Once micropuncture technique is used, it's always a good idea just to use
a quick fluoroscopic imaging to show that your access is actually where you want it to be. If it's not, you can always re-stick the patient again. Once you have the access in place, what can then happen is do a quick angio to show in fact you have reached the target vessel.
This is the routine instructions for use by placing the percutaneous suture-mediated closure system at 45 degree angles from one another, 90 degrees from one another. Once the sheath is in place for ruptured aneurysm, the placement of a ballon occlusion
can be done utilizing a long, at least 12 French sheath so that they'll keep that balloon up in place. What's also good is to keep a neat operative field, and by doing so, you can keep all of these wires and sutures clean and out of the way and also color code the sutures so that you have
ease and ability to close them later. Finally, it's important to replace the dilator back in the sheath prior to having it removed. This is important just so that if there are problems with your percutaneous closure, you can always very quickly replace your sheath back in.
Again, we tend to color code the sutures so we can know which ones go with which. You can also place yet a third percutaneous access closure device if need be by keeping the guide wire in place. One other little trick that I actually learned
from Ben Starnes when visiting his facility is to utilize a Rumel mediated technique by placing a short piece of IV tubing cut length, running the suture through that, and using it like a Rumel, and that frees up your hand as you're closing up
the other side and final with closure. The contraindications to pREVAR. And I just want to conclude that there's increased use of fully percutaneous access for endovascular repair. There's trending advantages over conventional surgical exposure with decreased
access related complications, and improved outcomes can be attributed to increased user experience and comfort with percutaneous access, and this appears to be a viable first option. Thank you very much.
- The main results of the mid-term, I would call it rather than long-term, there were three years of the improved trial, were published almost immediately after the Veith Symposium last year. I have no disclosures other than to say this was a great team effort, and it wasn't just me,
it was all the many contributors to this project. I think the important thing to start with is to understand the design. This was a randomized trial of unselected patients with a clinical diagnosis of ruptured abdominal aortic aneurysm.
The trial was to investigate whether EVAR as a first option, or an endovascular strategy, would save lives compared with open repair. We randomized 613 patients quite quickly across 30 centers, and this comprised 67 percent of those who would have been eligible for this trial, so good external validity.
Survival was the primary outcome for this trial. This was assessed at 30 days, one, and three years. At 30 days as you can see there was no difference between the endovascular strategy group in blue, and the open repair group in red. However, already at 30 days we noticed
that of the discharges in the endovascular strategy group, 97 percent of these went home, versus only 77 percent in the open repair group. No significant difference in survival at one year, but now out at three years, the survival is 56 percent in the endovascular strategy
group versus 48 percent in the open repair group. This is not quite significant. If we look only at the 502 patients who actually had a repair of a rupture, the benefits of the endovascular strategy are much stronger. And a compliance analysis,
because there were some crossovers in this pragmatic trial, shows very similar results. And for the 133 women, these were the real beneficiaries of an endovascular strategy. The cumulative incidence of re-interventions to three years are shown here, and no difference between open
and endovascular strategy. And I'll dwell on these in more detail in a later presentation. But this did mean that there was no additional cost to the endovascular strategy over the three year period. I'd also like to point out to you that
apart from the re-interventions, the need for renal support in the early days was 50 percent more common after open repair. Patients had rather different concerns about their complications to clinicians. And when we discussed this with patients they were most
concerned about limb amputation and possibly unclosed stomas. All of these were relatively uncommon, but we had a great collaboration with the other two ruptured aneurysm trials in Europe, AJAX and ECAR. And we put our data together.
Took 12 months, and here you can see the very consistent results. That amputations are considerably less common after endovascular repair for rupture than open repair. We've just heard about quality of life. In Improve Trial there were real gains in quality of life.
Up to three years in the endovascular strategy group. And since costs were lower, this meant that this strategy was highly cost-effective. So in summary, at three years an endovascular strategy proves to be better than open repair. With better survival, higher qualities for the patients
in the endovascular strategy group, marginally lower costs, and it's cost-effective. And we've heard quite a lot even at this meeting about our new NICE guidelines in the UK. But an endovascular strategy is actually being recommended by them for the repair of ruptures.
And I think the most cogent reasons to recommend endovascular repair are the fact that it has benefits for patients at all time points. It gives them what they want: Getting home quickly, better quality of life, lower rates of amputation and open stoma,
and better midterm survival. Thank you very much.
- [Doctor] Thank you Tom and thanks Dr Veith for the invitation to be here again. These are my disclosures, so hypogastric embolization is not benign, patients can develop buttock claudication, higher after bilateral sacrifice, it can be persistent in up to half of patients. Sexual dysfunction can also occur, and we know that
there can be catastrophic complications but fortunately they're relatively rare. So now these are avoidable, we no longer have to coil and cover in many patients and we can preserve internal iliac's with iliac branch devices like you just heard. We had previously published the results of looking from
the pivotal trial, looking at the Gore IBE device with the six month primary end point showing zero aneurysm-related morality, high rates of technical success, 95% patency of the internal iliac limb, no type one or type three endoleaks and 98% freedom from reintervention. Importantly on the side of the iliac branch device, there
was prevention of new-onset of buttock claudication in all patients, and importantly also on the contralateral side in patients with bilateral aneurysms that were sacrificed, the incidents in a prospect of trial of the development of buttock claudication was 28%, confirming the data from those prior series.
And this is in line with the results of EVAR using iliac branch device published by many others showing low rates of mortality, high rates of technical success and also good patency of the devices. In press now we have results with follow-up out through two years, in the Gore IBE trial, we also compared
those findings to outcomes in a real world experience from the great registry, so 98 patients from the pivotal and continued access arm's of the IBE trial and also 92 patients who underwent treatment with the Gore IBE device in the great registry giving us 190 patients with 207 IBE devices implanted.
Follow-up was up to three years, it was an longer mean follow-up in the IDE study with the IBE device. Looking at outcomes between the clinical trial and the real world experience, they were very similar. There was no aneurysm-related mortality, there was no recorded new-onset ipsilateral buttock claudication,
this is all from the IDE trial since we didn't have that information in the great registry, and looking at the incidence of reinterventions, it was similar both in the IDE clinical trial experience and also in the great registry as well. Looking at patency of the internal iliac limb, it was
93.6%, both at 12 months and 24 months in the prospective US IBE pivotall trial and importantly all the internal iliac limb occlusions occurred very early in the experience likely due to technical or anatomic factors. When we look at the incidence of type two endoleaks, we had previously noted there was a very high incidence of
type two endoleaks, 60% at one month, this did tail off a bit over time but it was still 35% at two years. A total of five patients in the pivotal IBE trial had a reintervention for type two endoleak through two years, and despite that high incidence of type two endoleak, overall the incidence of aortic aneurysm sac expansion
of more than five millimeters has been rare and low at two and nine percent at 12 and 24 months, and there's been no expansions of the treated common iliac artery aneurysm sac's at either 12 or 24 months. Freedom from reintervention has been quite good, 90.4% through two years in the trial and most of these
re-interventions were type two endoleaks. We now have some additional data out through three years in about two thirds of the patients we have imaging data available now through three years in the pivotal IBE trial, there have been no additional events, device related events reported since the two year data and through three years
we have no recorded type one or type three endoleaks, no aneurysm ruptures, no incidences of migration, very high rates of patency of the external and internal iliac arteries, good freedom from re-intervention and good freedom from common iliac artery aneurysm sac enlargement. And I think, in line with these findings, the guidelines
now from the SVS are to recommend preservation of the internal iliac arteries when ever present and that's a grade 1A recommendation, thank you.
- Good morning. I'd like to thank Dr. Veith and Symposium for my opportunity to speak. I have no disclosures. So the in Endovascular Surgery, there is decrease open surgical bypass. But, bypass is still required for many patients with PAD.
Autologous vein is preferred for increase patency lower infection rate. And, Traditional Open Vein Harvest does require lengthy incisions. In 1996 cardiac surgery reported Endoscopic Vein Harvest. So the early prospective randomized trial
in the cardiac literature, did report wound complications from Open Vein Harvest to be as high as 19-20%, and decreased down to 4% with Endoscopic Vein Harvest. Lopes et al, initially, reported increase risk of 12-18 month graft failure and increased three year mortality.
But, there were many small studies that show no effect on patency and decreased wound complications. So, in 2005, Endoscopic Vein Harvest was recommended as standard of care in cardiac surgical patients. So what about our field? The advantages of Open Vein Harvest,
we all know how to do it. There's no learning curve. It's performed under direct visualization. Side branches are ligated with suture and divided sharply. Long term patency of the bypass is established. Disadvantages of the Open Vein Harvest,
large wound or many skip wounds has an increased morbidity. PAD patients have an increased risk for wound complications compared to the cardiac patients as high as 22-44%. The poor healing can be due to ischemia, diabetes, renal failure, and other comorbid conditions.
These can include hematoma, dehiscense, infection, and increased length of stay. So the advantages of Endoscopic Vein Harvest, is that there's no long incisions, they can be performed via one or two small incisions. Limiting the size of an incision
decreases wound complications. It's the standard of care in cardiac surgery, and there's an overall lower morbidity. The disadvantages of is that there's a learning curve. Electro-cautery is used to divide the branches, you need longer vein compared to cardiac surgery.
There's concern about inferior primary patency, and there are variable wound complications reported. So recent PAD data, there, in 2014, a review of the Society of Vascular Surgery registry, of 5000 patients, showed that continuous Open Vein Harvest
was performed 49% of the time and a Endo Vein Harvest about 13% of the time. The primary patency was 70%, for Continuous versus just under 59% for Endoscopic, and that was significant. Endoscopic Vein Harvest was found to be an independent risk factor for a lower one year
primary patency, in the study. And, the length of stay due to wounds was not significantly different. So, systematic review of Endoscopic Vein Harvest data in the lower extremity bypass from '96 to 2013 did show that this technique may reduce
primary patency with no change in wound complications. Reasons for decreased primary patency, inexperienced operator, increased electrocautery injury to the vein. Increase in vein manipulation, you can't do the no touch technique,
like you could do with an Open Harvest. You need a longer conduit. So, I do believe there's a roll for this, in the vascular surgeon's armamentarium. I would recommend, how I use it in my practices is, I'm fairly inexperienced with Endoscopic Vein Harvest,
so I do work with the cardiac PA's. With increased percutaneous procedures, my practice has seen decreased Saphenous Vein Bypasses, so, I've less volume to master the technique. If the PA is not available, or the conduit is small, I recommend an Open Vein Harvest.
The PA can decrease the labor required during these cases. So, it's sometimes nice to have help with these long cases. Close surveillance follow up with Non-Invasive Arterial Imaging is mandatory every three months for the first year at least. Thank you.
- I want to thank Dr. Vee for the invitaion and the opportunity to participate. These are my disclosures. I also want to acknowledge my friend, Gustav Aldrich, some of the images and the slides were shared by him with me. So, as you know, 20% to 40% of infrarenal abdominal
aortic aneurysms are considered complex because either they don't have any neck or because the aneurysm extends above the renal arteries and therefor, cannot be treated with the standard lever devices. And obviously thoracoabdominal aortic aneurysms
are primarily treated, at least in the United States, using open repair. And as you know, the problem with open repair is that the morbidity and mortality are really significant and that is particularly true when you analyze the outcomes of population based studies.
And that's obviously something that needs to improve. Overall mortality almost 20% in 30 days. Now, fenestrated branch devices would allow you to treat most of these complex aortic aneurysms. In fact, there is over 60,000 of these endografts that have been implanted world-wide.
In the United States the only one available, fenestrated device available, is the Z-Fen device which only allows you to treat juxta-renal triple A's. In order to get access to more complex devices that would allow you to treat thoracoabdominal aneurysm, you have to get an IDE.
We were fortunate to get one of these several years ago. And our experience is based on the use about the Z-Fen and these types of devices. Patient with fenestrating branch is that it has been used primarily for high-risk patients. But, it's unknown if this could be used also for all-comers,
especially patients with standard risk. And they know this study which just says the perioperative outcomes of fenestrated branch EVAR among patients that are considered standard risk versus those that are high risk. One of the important points to highlight here
is that IRD allows us to treat all patients, not only high risk patients, which is a little different from most of the other IDE's. So, during a four year period, 206 patients underwent fenestrated-branch EVAR. 81% of these were male, 19% female.
The median age of these patients was 72 years, and the median aneurysm size was 58 millimeters. Half of the cases were performed with a Z-Fen device. 40% were performed with custom-made devices, 4% with a P-branch off the shelf device. And 4% with a T-branch device.
Now we separated or defined the surgical risk based on the ESVS medical cardio-mobility graded system. Which says the cardio status, pulmonary status, the renal condition and other minor components such as hypertension and age, the lower the score the lower the risk, usually standard risk patients
are those considered fit for open repair. Now based on this score, 78% of the patients were considered high risk versus 22% were considered standard or low risk. The early results, technical success was 100%. The median operative time was a little longer
for the high risk patients, 243 minutes versus 192 in the standard risk patients. Median hospital stays was not significantly different. And the median ICU stays was similar. The 30 day results, there was two patients that died for the 30 day mortality of 1%.
This was due to urosepsis and intracranial bleeding. Complications, 35% for high risk and 28% for standard risk. One year results, for the entire cohort, freedom from endoleaks 85%, freedom from re-intervention 78%, target vessel patency 98%.
And patient survival at one year, 87% for high risk patients and 100% for standard risk patients. Obviously, there's an added benefit in survival for standard risk patients. Sac shrinkage was noted in the majority of patients. So we believe that based on these results
fenestrated-branch EVAR is safe and effective in both high and standard risk patients. But we believe the standard risk patients benefit the most given their significant improved survival as well as their early recovered. So we believe for that reason fenestrating-branch EVAR
should be expanded to all patients. Thank you.
- First of all let me thank Dr. Veith for the kind invitation to be here again and it's my great pleasure to share with you the preliminary result of our Indian registry. So these are my disclosures. So as vascular surgeon we have to admit that the Fogarty embolectomy has many possibility
but also some limitation. You can see here in this short video that we were able to remove thrombus, but thrombus was mixed up with plaque, hyperplasia and the final result was a very poor backflow from this vessel.
So already a couple of years ago we published our experience comparing the Fogarty embolectomy with the hybrid treatment that at that time was Fogarty plus a lot of endovascular rescue maneuver and of course hybrid was better, but we were very surprised by this.
What we found that the introvert in geography after Fogarty we had a number of chronic disease this is normal, but we also found a number of residual thrombus because firmly adherent to the arterial wall or just not appropriately reached by the Fogarty balloon embolectomy.
Even the over the Y Fogarty balloon embolectomy cannot work enough well. And then finally we also had a number of case with the injuries. Probably from inappropriate Fogarty balloon maneuver into the vessels so we had to find something more.
We had to find something less traumatic and so we realized that at the same time our colleagues from stroke unit, the neurologist had already a very nice tool in their hands. It's the Penumbra system which has began the market leader in stroke because it's very atraumatic,
dedicated for intracranial vessel navigation and then has a very high aspiration power system. So a couple of years later the company came on the market with the family dedicated to peripheral artery, the Indigo System from three to eight French catheter
designed for peripheral artery. So really improved trackability and atraumatic tip of this catheter. So how does the system work? You have already seen this video, but anyway you have first to engage the clot then you switch on
the aspiration power and then from proximal to distal you can remove all the thrombus, you can use the separator guide wire that breaks up the clot when ingested into the catheter and so the final result is that the tip of catheter is all we part and that you can remove all the thrombus
in very few minutes. Now I want to show to you my very first case it was four years ago and the system was not yet available and I for prefer I had some conflicting result with the other with competitors. I have incomplete reperfusion or hemolysis.
I have very positive feedback from my colleagues from the stroke unit at my University. I had the possibility to borrow the neuro catheters. So in this very first patients, unfit for lysis with a lot of thrombus, fresh thrombus in a vein popliteal area and the tibial artery I used
neural catheters, separate was very easy even at the beginning of our experience and we were able to engage the clot use the separator and removing in a couple of passage old thrombus even from the very distal localizations. So up to now we have used the Indigo family,
Indigo system in a lot of situation I can go through all this the one, but I want to show you how far we can go and it's a very challenging situation within dialysis dependent patients with the calcify kink and tibial artery and thrombus in the plantar arch
we were able to reach the plantar arch with the CAT 3 device and remove all the thrombus. Since then we have decided to collect data in a prospective national registry, the Indian registry. We want to collect 150 case in this prospective registry. We started last year and we actually included any kind
of acute lower limb ischemia embolism, thrombosis, graft endograft thrombosis, distal emboli and secondary to preceding intervention or even incomplete reperfusion after Fogarty and lysis. We evaluated the vessel patency by TIMI score of course we have now 136 patients enrolled by 17 centers active
and Ethiological hypothesis of the ischemia was in the 3/4 of case thrombotic, so the most challenging case. Acute and chronic ischemia mainly in very popliteal area or even below the knee or below the ankle in arteries. And here are preliminary result available for 120 patients.
After the Indigo use we already have a 90% TIMI two or three flow restoration will raise up to 96% after additional PTA or stent or additional lysis. So in conclusion these are only the preliminary result I hope to share with you our final result next year,
but at that moment we can already say that the Indigo is safe and effective option for acute lower limb ischemia, technical success is high even in small arteries, and up to now adverse event related to the device is very low and bleeding and hemolysis are not reported.
- All right, thanks Ed. Thanks to Frank for the kind invitation. I guess I get to be a little bit of a tiebreaker maybe from the debate. So I wanted to bring your attention and spend a couple minutes talking about a paper that we had presented at the VAM last year,
that is in press in the journal now. So, we wanted to focus a little bit differently. Rather than the question of you know, separating the cohort by diameter, but actually by separating the cohort by the actual device used. And the idea had come from several of the papers
that folks have already brought up. That standard EVAR with wide infrarenal necks lead to future problems. So we actually sort of asked, you know, asked the question slightly differently, so how about if we had to use for whatever reason, surgeon choice,
preference, a 34, 36 millimeter graft, what were those outcomes? So it's a slightly different take on the question. So we looked at R-series over 15 years. Nearly 900 patients. Excluded, symptomatic, rupture ones,
many of the adjunctive things that Dr. Abramov brought up. Complex EVAR fenestrated snorkel anchors. We left those out, and just looked at 500, what we called standard infrarenal cases. Cases that we had to use a device less than 34 in diameter, or those that we used a device with
a 34 to 36 millimeter graft. So that was 392 versus 108. This video just goes through generally how we double-checked all of our measurements, it's a lot of work for our fellow to go back through and segment out all of the old scans and make accurate neck measurements
in order to provide some clarity to both the reasons why we chose a certain graft, as well as to provide some accurate measurements, rather than just going back and looking at the op reports. So we did that for all 500 patients. Came up with a composite endpoint of proximal
fixation failure, which was any type one A endoleak indicated on followup and or stent graft migration of 10 millimeters, and looked at the usual secondary outcomes. So nearly 400 patients with a small neck device, again, 32 and lower, and 108 patients
with a large neck device, 34, 35, or 36 millimeters in diameter. Most of the demographics were similar, except for a higher proportion of CKD in the small neck group. And then some odd findings related to stroke and hyperlipidemia.
Obviously, the neck diameter was higher in the patients that had the large neck. Notice how tight the numbers actually were. 29 plus or minus 1.5. So these weren't way outside of the IFU in terms of using the 34, 35 or 36 millimeter graft.
Reverse taper, there was a higher proportion of those patients that have that. To bring up some of the points brought up earlier, sometimes it's difficult to distill out whether it's a parallel neck or not in that, you know, in that scenario.
Interestingly, the small neck cohort actually had a higher likelihood of having an angulated greater than 60 degree neck. And then, it was more calcified. So that could argue even the small neck group is already slightly disadvantaged,
'cause while they were smaller necks, it might have had some of those other features. These were the devices used during this study period. And time point, equal numbers really. Device oversizing, whether in the small or large neck was relatively equal.
So these are some examples of patients that had lost some proximal fixation. One with Cook Zenith device, and one with a now-defunct Metronic Talent device. Followup was nearly three years. The type one A endoleak rate was
15% in the large neck cohort, versus three percent for the small neck. Stent graft migration, 14% versus 4%, so composite end point of 24% versus 6%. Obviously significant. Large diameter devices were associated
with a fourfold increase in failed proximal fixation. Mortality, endoleak and reinterventions were interestingly the same between the cohorts. Again, the types of devices typically found to be higher in these types of patients because of the number of devices available from these manufacturers.
On univariate analysis then, the reverse taper neck, neck diameter greater than 29 and the use of a talent was associated with that. Multivariate model, it's really just the neck diameter being large as well as the use of the now no longer used talent device.
So in summary, large infrarenal necks treated with 34 to 36 millimeter proximal diameter endografts are associated with a 2.5 time higher risk of proximal fixation failure. Even when controlling for angulation, calcification, thrombus shape and device type.
So when treating these patients, much like my predecessors have mentioned, one should consider either more close followup or some other adjunct. So nowadays when we stare at a neck like this, where we're measuring over 15 millimeters, 29 to 31, and you might suggest that you put
in an infrarenal device to get fixation there, we've moved towards now either some sort of adjunct of either fenestrated or snorkel graft for that. Thank you.
- Thank you again Rex. This is again my disclosure, the same. I think you agree with me that we all do not want these images and after the procedure in our patients or in followup. We might be able to keep this reconstructions patent by continuing accuracy ventricle relation
but there is somehow a disturbance of the venous flow. If we we advocate that 50% stenosis is significant. Flexibility is one reason why we have already the first generation of dedicated venous stents. These are the currently available, excuse me, currently available venous stents
in the European market and despite very different structures, geometries and characteristics they all want to combine the best balance between flexibility, radial force, crush resistance or porosity. So this is not a real scientific way to show
or to evaluate the flexibility but it shows you that there are really differences between the current dedicated venous stents regarding the flexibility and we have closed cell stent, we have open celled stent, we have woven stent, we have laser knitted stent,
we have hybrid or segmented stent. So let us go to one case from our center. We re-cannulized the left iliac tract as you can see here. We used the closed cell stent at the proximal part, lengthen it with a dedicated venous
open cell segmented stent below the ligament going into the common femoral vein as you can see here. So going into the axial plane with duplex we see a very nice cross sectional shape below the artery at the mitonal point. This stent performs very well here
but a few centimeters more distal we have a destroyed cross sectional shape. Going into the detail, the same patient in longitudinal evaluation with stent we see three different diameters and if we take the proximal diameter
you see again the same picture with a minimum diameter of 1.27 maximum diameter of 1.57 giving us a 1.57 square centimeters of area and this is a 1.23 aspect ratio. Taking the kink, the level of the kink, we have the destroyed picture.
Minimum diameter 0.65, maximum diameter of 1.47 giving us only a 0.89 square centimeters and regarding the published and the aspect ratio is 2.3 and regarding this 2008 published paper which showed that area affects outcome and the recent work of Lowell Kabnick
which shows that not only the area but also the aspect ratio affects the outcome. We have to conclude that in this patient, of our center this kink might destroy or might affect the outcome. This is the literature you heard in the last session
already the patency rates of all stents but my message from this table is they included only a small number of patients with short followups as you can see ranging from 10 to 12 but despite very different flexibilities
which we have seen in the second slide we have no significant differences regarding the patency or the outcome and therefore whether more flexibility leads to a better clinical outcome remains still unclear. In conclusion, there is no doubt
that flexibility is important. The flexibility of majority of current venous stents seems to be enough. Till date with currently available studies we cannot answer how much flexibility we need. Where is the threshold
to say this is good and the other is bad? If more flexibility means really better outcome and it is not only the stent, it is more the pattern of disease which affects the outcome. So we started with arterial stents in the venous pathology, we improved to first generation of dedicated venous stents
but we are looking for best stents. Thank you very much.
- Thank you very much. After these beautiful two presentations a 4D ultrasound, it might look very old-fashioned to you. These are my disclosures. Last year, I presented on 4D ultrasound and the way how it can assess wall stress. Now, we know that from a biomechanical point,
it's clear that an aneurysm will rupture when the mechanical stress exceeds the local strength. So, it's important to know something about the state of the aortic wall, the mechanical properties and the stress that's all combined in the wall.
And that could be a better predictor for growth and potential rupture of the aneurysm. It has been performed peak wall stress analysis, using finite element analysis based on CT scan. Now, there has been a test looking at CT scans with and without rupture and given indication
what wall stress could predict in growth and rupture. Unfortunately, there has been no longitudinal studies to validate this system because of the limitations in radiation and nephrotoxic contrast. So, we thought that we could overcome these problems and building the possibilities for longitudinal studies
to do this similar assessment using ultrasound. As you can see here in this diagram in CT scan, mechanical properties and the wall thickness is fixed data based on the literature. Whereas with 3D ultrasound, you can get these mechanical properties from patient-specific imaging
that could give a more patient-specific mechanical AA model. We're still performing a longitudinal study. We started almost four years ago. We're following 320 patients, and every time when they come in surveillance, we perform a 3D ultrasound. I presented last year that we are able to,
with 3D ultrasound, we get adequate anatomy and the geometry is comparable to CT scan, and we get adequate wall stressors and mechanical parameters if we compare it with CT scan. Now, there are still some limitations in 3D ultrasound and that's the limited field of view and the cumbersome procedure and time-consuming procedures
to perform all the segmentation. So last year, we worked on increased field of view and automatic segmentation. As you can see, this is a single image where the aneurysm fits perfectly well in the field of view. But, when the aneurysm is larger, it will not fit
in a single view and you need multi-perspective imaging with multiple images that should be fused and so create one image in all. First, we perform the segmentation of the proximal and distal segment, and that's a segmentation algorithm that is
based on a well-established active deformable contour that was published in 1988 by Kass. Now, this is actually what we're doing. We're taking the proximal segment of the aneurysm. We're taking the distal segment. We perform the segmentation based on the algorithms,
and when we have the two images, we do a registration, sort of a merging of these imaging, first based on the central line. And then afterwards, there is an optimalisation of these images so that they finally perfectly fit on each other.
Once we've done that, we merge these data and we get the merged ultrasound data of a much larger field of view. And after that, we perform the final segmentation, as you can see here. By doing that, we have an increased field of view and we have an automatic segmentation system
that makes the procedure's analysis much and much less time-consuming. We validate it with CT scan and you can see that on the geometry, we have on the single assessment and the multi assessments, we have good similarity images. We also performed a verification on wall stress
and you can see that with these merged images, compared to CT scan, we get very good wall stress assessment compared to CT scan. Now, this is our view to the future. We believe that in a couple of years, we have all the algorithms aligned so that we can perform
a 3D ultrasound of the aorta, and we can see that based on the mechanical parameters that aneurysm is safe, or is maybe at risk, or as you see, when it's red, there is indication for surgery. This is where we want to go.
I give you a short sneak preview that we performed. We started the analysis of a longitudinal study and we're looking at if we could predict growth and rupture. As you can see on the left side, you see that we're looking at the wall stresses. There is no increase in wall stress in the patient
before the aneurysm ruptures. On the other side, there is a clear change in the stiffness of the aneurysm before it ruptures. So, it might be that wall stress is not a predictor for growth and rupture, but that mechanical parameters, like aneurysm stiffness, is a much better predictor.
But we hope to present on that more solid data next year. Thank you very much.
- Thank you Mr. Chairman, good morning ladies and gentlemen. So that was a great setting of the stage for understanding that we need to prevent reinterventions of course. So we looked at the data from the DREAM trial. We're all aware that we can try
to predict secondary interventions using preoperative CT parameters of EVAR patients. This is from the EVAR one trial, from Thomas Wyss. We can look at the aortic neck, greater angulation and more calcification.
And the common iliac artery, thrombus or tortuosity, are all features that are associated with the likelihood of reinterventions. We also know that we can use postoperative CT scans to predict reinterventions. But, as a matter of fact, of course,
secondary sac growth is a reason for reintervention, so that is really too late to predict it. There are a lot of reinterventions. This is from our long term analysis from DREAM, and as you can see the freedom, survival freedom of reinterventions in the endovascular repair group
is around 62% at 12 years. So one in three patients do get confronted with some sort of reintervention. Now what can be predicted? We thought that the proximal neck reinterventions would possibly be predicted
by type 1a Endoleaks and migration and iliac thrombosis by configurational changes, stenosis and kinks. So the hypothesis was: The increase of the neck diameter predicts proximal type 1 Endoleak and migration, not farfetched.
And aneurysm shrinkage maybe predicts iliac limb occlusion. Now in the DREAM trial, we had a pretty solid follow-up and all patients had CT scans for the first 24 months, so the idea was really to use
those case record forms to try to predict the longer term reinterventions after four, five, six years. These are all the measurements that we had. For this little study, and it is preliminary analysis now,
but I will be presenting the maximal neck diameter at the proximal anastomosis. The aneurysm diameter, the sac diameter, and the length of the remaining sac after EVAR. Baseline characteristics. And these are the re-interventions.
For any indications, we had 143 secondary interventions. 99 of those were following EVAR in 54 patients. By further breaking it down, we found 18 reinterventions for proximal neck complications, and 19 reinterventions
for thrombo-occlusive limb complications. So those are the complications we are trying to predict. So when you put everything in a graph, like the graphs from the EVAR 1 trial, you get these curves,
and this is the neck diameter in patients without neck reintervention, zero, one month, six months, 12, 18, and 24 months. There's a general increase of the diameter that we know.
But notice it, there are a lot of patients that have an increase here, and never had any reintervention. We had a couple of reinterventions in the long run, and all of these spaces seem to be staying relatively stable,
so that's not helping much. This is the same information for the aortic length reinterventions. So statistical analysis of these amounts of data and longitudinal measures is not that easy. So here we are looking at
the neck diameters compared for all patients with 12 month full follow-up, 18 and 24. You see there's really nothing happening. The only thing is that we found the sac diameter after EVAR seems to be decreasing more for patients who have had reinterventions
at their iliac limbs for thrombo-occlusive disease. That is something we recognize from the literature, and especially from these stent grafts in the early 2000s. So conclusion, Mr. Chairman, ladies and gentlemen, CT changes in the first two months after EVAR
predict not a lot. Neck diameter was not predictive for neck-reinterventions. Sac diameter seems to be associated with iliac limb reinterventions, and aneurysm length was not predictive
of iliac limb reinterventions. Thank you very much.
- Thank you. We've all heard that hypogastric artery occlusion can be not so benign as Dr. Snyder mentioned. It's not advancing, there we go. There's the systematic meta-analysis of 61 papers and showing that when you have bilateral occlusion you actually can have worse symptoms
of claudication, even erectile dysfunction. There are these known commercially available devices but should we be doing bilateral cases? There's certainly increased complexity inherent in this and anatomic limitations and cost. We choose to look at a multicenter experience
of 24 centers, 47 patients. Here are the contributing contributors. When we published our experience these are the 47 patients using the GORE IBE device both in Europe and the United States with 6.5 month follow up. The aortic diameters, some of the characteristics.
You can see here that 23% had exclusive iliac aneurysm treatment in the absence of a AAA. Four had aneurysmal or ectatic internal iliac arteries. These are sometimes treated by coil embolizing the first branch and extending the internal branch into a first order branch, there you can see.
But anatomic limitations persist and you can see especially with lengths. You need quite a long length for that ipsilateral side with its device in order to do the bilateral case. These are the IFUs, 165 for the contra and 195 for the ipsi. In our experience you can see that actually 194 on the ipsi
and 195 is what we found as a mean. This seems prohibitive. Some of the tips and tricks to accommodate the shorter lengths are shown here. We can maximize overlap, and we can see that from 195 we can drop this
by maximizing the overlap to 175. We can certainly cross the limbs, that eats up some length. Intrinsic tortuosity can eat up the distance. We can see we can recreate the flow divider, bring up the flow divider higher, match the two limbs. That also can cut down the distance.
Finally in some of these patients we had shorter bridging stents, the endurant stent in particular is a little shorter instead of the 100 millimeter Gore limb and that can also shorten the distance. More about the procedural outcomes. You can see here great technical success.
There were no type one or type three endoleaks. There were some adjunctive stenting in some patients, four patients, because of some kinking and distal dissection. One technical failure's worth pointing out. This is a patient who has heavy calcification
in the iliac system here. Couldn't cannulate, the internal iliac artery required coil embolization. You can see this patient, we had to sacrifice that internal and extend into the external. Complications at 30 days are very acceptable.
One groin infection. You can see that radiographing clinical follow up. One patient with new buttock claudications, a patient who lost the internal iliac artery as I'll mention to you in a minute. The other one was asymptomatic
but also one internal iliac artery lost. No aneurysm related deaths. You can see there's some type two endoleaks but not type one or three endoleaks. More about limb occlusions. This is the external iliac limb.
You can see there were three external iliac limb occlusions, two in the perioperative period and one at six months which presented with claudication requiring a Fem-Fem. The two in the perioperative period, one was a thrombectomy and stent that was treated nicely. The other one was really an iatrogenic limb occlusion
because the internal branch was deployed inadvertently high jailing the external and causing the operators to have to go back and essentially sacrifice that internal in order to preserve flow to the external. You can see that this a patient who in fact did have the claudication symptoms, this is that one patient.
As far as internal iliac limb occlusion in addition to the one we just described there was one asymptomatic incidental find of a limb occlusion at six months. This is a comparison of what Dr. Snyder just discussed, the pivotal trial with expanded access to the global experience I just presented.
You can see when you look at fluoroscopy time, for instance, contrast media used or procedural duration that there is, of course, some increase requirement in the bilateral cases but I would argue that this is not prohibitive. Cost, however, may in fact be an issue.
Certainly this can be a quite costly procedure when we start doing bilateral cases. There are, in fact, new procedure codes that Gore has provided that can offset some of this cost especially for the hospital cost, but nonetheless this is something to be considered.
So in conclusion, preservation of bilateral internal iliac artery with a Gore IBE can be performed safely with excellent technical results and short term patency rates. Only one new onset of buttock claudication occurred in that inadvertent limb jailing. Limb and branch occlusions are rare but can be treated
successfully with stenting most of the time. Some anatomic limitations exist but a number of maneuvers can permit technical success even in shorter length aortoiliac segments. Contrast fluoroscopy and length of case do not appear to be prohibitive.
However, cost remains an issue. Thank you.
- Thank you, thanks for the opportunity to present. I have no disclosures. So, we all know that wounds are becoming more prevalent in our population, about 5% of the patient population has these non-healing wounds at a very significant economic cost, and it's a really high chance of lower extremity amputation
in these patients compared to other populations. The five-year survival following amputation from a foot ulcer is about 50%, which is actually a rate that's worse than most cancer, so this is a really significant problem. Now, even more significant than just a non-healing wound
is a wound that has both a venous and an arterial component to it. These patients are about at five to seven times the risk of getting an amputation, the end patients with either isolated venous disease or isolated PAD. It's important because the venous insufficiency component
brings about a lot more inflammation, and as we know, this is associated with either superficial or deep reflux, a history of DVT or incompetent perforators, but this adds an increasing complexity to these ulcers that refuse to heal.
So, it's estimated now about 15% of these ulcers are more of a mixed etiology, we define these as anyone who has some component of PAD, meaning an ABI of under point nine, and either superficial or deep reflux or a DVT on duplex ultrasound.
So we're going to talk for just a second about how do we treat these. Do we revascularize them first, do we do compression therapy? It has been shown in many, many studies, as with most things, that a multi-disciplinary approach
will improve the outcome of these patients, and the first step in any algorithm for these patients involves removing necrotic and infected tissue, dressings, if compression is feasible, based on the PAD level, you want to go ahead and do this secondary, if it's not, then you need to revascularize first,
and I'm going to show you our algorithm at Michigan that's based on summa the data. But remember that if the wounds fail to heal despite all of this, revascularization is a good option. So, based on the data, the algorithm that we typically use is if an ABI is less than point five
or a toe pressure is under 50, you want to revascularize first, I'll talk for a minute about the data of percutaneous versus open in these patients, but these are the patients you want to avoid compression in as a first line therapy.
If you have more moderate PAD, like in the point five to point eight range, you want to consider compression at the normal 40 millimeters of mercury, but you may need to modify it. It's actually been shown that that 40 millimeter of mercury
compression actually will increase flow to those wounds, so, contrary to what had previously been thought. So, revascularization, the data's pretty much equivocal right now, for these patients with these mixed ulcers, of whether you want to do endovascular or open. In diabetics, I think the data strongly favors
doing an open bypass if they have a good autogenous conduit and a good target, but you have to remember, in these patients, they have so much inflammation in the leg that wound healing from the surgical incisions is going to be significantly more difficult
than in a standard PAD patient, but the data has shown that about 60% of these ulcers heal at one year following revascularization. So, compression therapy, which is the mainstay either after revascularization in the severe PAD group or as a first line in the moderate group,
is really important 'cause it, again, increases blood flow to the wound. They've shown that that 40 millimeters of mercury compression is associated with a significant healing rate if you can do that, you additionally have to be careful, though,
about padding your bony areas, also, as we know, most patients don't actually keep their compression level at that 40, so there are sensors and other wearable technologies that are coming about that help patients with that, keeping in mind too, that the venous disease component
in these patients is really important, it's really important to treat the superficial venous reflux, EVLT is kind of the standard for that, treatment of perforators greater than five, all of that will help.
And I'm not going to go into any details of wound dressings, but there are plenty of new dressings that are available that can be used in conjunction with compression therapy. So, our final algorithm is we have a patient with these mixed arterial venous ulcers, we do woundcare debridement, determine the degree of PAD,
if it's severe, they go down the revascularization pathway, followed by compression, if it's moderate, then they get compression therapy first, possible treatment of venous disease, if it still doesn't heal at about 35 weeks, then you have to consider other things,
like biopsy for cancer, and then also consider revacularization. So, these ulcers are on a rise, they're a common problem, probably we need randomized control trials to figure out the optimal treatment strategies.
- The FLEX Scoring Catheter is one of the new tools, which is dedicated to vessel preparation, either as a stent, as a therapy followed by plain balloon angioplasty, or preparing the vessel for drug-eluting balloons and stents. So, the background basically is that
we're more and more tackling chronic total occlusions, and these kind of lesions, they have an increased risk of being calcium-containing, creating dissections, perforations, embolization, and poor luminal gain. And for that purpose, this device, which is more or less
a kind of surgical device, was developed. It's a interventional tool which can be introduced via a six-French sheath. It's an over-the-wire system, running over a 14 or 18 thousandths guide wire. It's common in shaft lengths of
40 centimeters dedicated to AV, fistula treatment and 120 centimeters, and the device is exposed to the vessel wall with three atherotomes, with the indication for femoropopiliteal and AV fistula excess treatment. One size fits all is really the right description
of this device, except having two different shaft lengths, the device itself is coming in one size only. What does it result in? Well, it results in micro-incisions, as you can see it over here, also over here in an OCT image, and the depths of these incisions
is about 0.5 millimeters, the pressure which is applied to the surface is about one atmosphere, independent on the vessel size. So, the idea and the rationale for this device is to facilitate and increase the vessel compliance and to create an controlled environment for angioplasty.
There are, just recently, some specimen analysis performed by CBSET, what you can see over here, marked by arrows, these arrows indicate the FLEX-induced micro-incisions, and you can see that these incisions are really circumferential with controlled,
uniform depths of those incisions into the plaque or the vessel wall. This is a 150 times magnification and you can see these longitudinal micro-incisions, which are very much parallel, it's like using a cutting balloon,
the advantage, however, is that this device can be applied to even longer lesions, the limitation of a cutting balloon is the balloon length of 20 centimeters only. So what are the early results? I can present you the acute outcomes
of 100 patients' sample size, with chronic total femoropopliteal occlusions. We can see that the average lesion length was really significant, 191 millimeters, the range was up to 35 centimeters, and there was moderate to severe calcification
in almost 50% of those cases. The luminal gain post FLEX application was about 31%, and the following balloon opening pressure, which was documented within this registry, was four atmospheres only, which is a signal that really the vessel compliance
is significantly improved, considering the almost 50% of moderate to severe calcification of those lesions. There had been no emboli, there had been no flow-limiting dissections, nevertheless, the provisional stent use was still high with 19%.
This is one of two case examples I would like to share with you. This was an instant re-occlusion of the popliteal artery, 10 centimeters in length, this was passed with an 18 thousandths guide wire, three passes with the FLEX catheter had been performed,
as you can see over here. And this was then, this was the result after FLEX catheter application and this is post additional drug-coated balloon angioplasty, there was no dissection, there was no significant residual stenosis.
Another case example, unfortunately, the video will not run, this was a long distance flush occlusion of the SFA, and you can see the calcium here in the entire length of the lesion, this lesion was treated, again, with the FLEX catheter, here, the video is not running,
this is the final result after DCB application. So, in summary, there's a high degree of technical success in achieving consistent luminal gain post FLEX, there's a low opening balloon pressure, and the re-canalization of CTOs was possible with a low rate, zero rate of significant dissections
and the low provisional stent rate. Thank you very much.
- Thank you very much for having me speak and thank you for coming this late in the day for this talk. These are my disclosures. This is our current operating system with advanced imaging and this is GE Discovery IGS 740. You can see you have fusion imaging,
you have the capacity to use combined CT. What I would like to talk to you today is about how we were significantly decrease radiation over the years. What you are seeing on this graph is my personal volume of endovascular cases. In the solid bullets you've the number of fenestrated cases
which have steadily increased over the years and in the empty rounds you've the number of any endovascular case. So what this is saying is that I am doing more fenestrated than more standard endovascular cases. And nowadays these cases are becoming more complex.
You're seeing here the number of vessels incorporated went from 2.9 all the way to 3.7 per patient. Now, at the same time, I did get better over the years. You can see that the fluoroscopy time for the procedures declined after two or three years of experience but it plateaued in 2012.
So, basically, since 2012, I am not doing these cases any faster with any last fluoroscopy time. So any change in the operator or in the patient radiation exposure would be attributed to other factors but the technique. You can see here the effective dose over the years
has dramatically declined from system 1 to system 2 to now system 3 in the blue that is the GE Discovery system to approximately 1/3rd to 1/4th of our baseline dose in the first beginning of the experience. We also recorded the operator dose over the year and you can see here that my radiation dose
has significantly declined again to about 1/3rd to 1/4th of the beginning of the experience. So, how did we achieve this improvement? I will go for eight golden rules, first is doing your work ahead of time, finding out the ideal work positions, using and leveraging all preoperative cross-sectional
imaging that you've, numerous of speakers have already talked about that, our highlights the importance of lead shooting with the work of Dijon which has a thing being remarkable contribution to the understanding of this. Optimize the system geometry, I think is very important avoiding work with the detector too high, the table low
as the abstracted on these illustration or the opposite with the table too high and really finding your way to the optimal geometry. I am sorry I advanceed, the slide is wrong way. Using the ideal dose rate, you can see here that the ideal dose rate in most operators has been down
now to 7.5 frames per second, and in some systems even 3.75 frames per second. We tend to use 7.5, we found this to be the soft spot with our system. ONLAY fusion has been also an important aspect in terms of facilitating the procedure, you're seeing
a segment of a patient before chronic dissection where you're leveraging the fusion to find the septum of trolloming using a reentrance device and really minimizing the amount of contrast and minimizing fluoroscopy, finding your ideal work position or with the use of these landmark markings
than with the fusion. Finally, nice feature of the system is the digital zoom. We really rarely magnify. What you're seeing here is a basically, digitally zoom different than magnification, so that really has allowed us to keep the dose very low
coupled with the collimation. And I think, this is a nice feature. We really avoid using DSAs unless you've to interrogate vessel. It is important to remember that 1 DSA is equivalent to approximately 500 fluoroscopic look.
So, what you're seeing here is the interrogation of a left renal stent done with a fluoroscopic loop as opposed to DSA. And, that is again a very important aspect. Avoiding high angulations wave when you're working in the sma or the celiac axis, we actually tend to that often
with the AP as opposed to the lateral view as soon as you can, you kind of transfer the image to the AP view to minimize radiation. So, in summary, we came a long ways, in terms of standard and complex EVAR where living now in a narrate that we've better devices, we've cross sectional imaging and we've
advanced image and I think we need to leverage all these three aspects to minimize radiation. Thank you very much
- The committee asked me to give an update on the Cook p-Branch device which is in a clinical trial in the United States. This is the disclosures as it relates to this talk. I'm going to discuss the feasibility as well as the pivotal study as you see on this slide. Now these two studies, as you can imagine,
have a different number of patients. The feasibility study was done in 30 patients and, as all studies in the U.S., required a five-year follow-up. And the p-Branch pivotal study is involving 82 patients with also a five-year follow-up, with the objectives really to assess the device's
safety and effectiveness and primary endpoints, treatment at one year. Now, the feasibility study enrolled 30 patients at 10 U.S. sites over a two and a half year period, roughly. So here the mean age was 73 years and maximum aneurysm diameter's 65 millimeters
and proximal neck length with the enrolled patients was 21 millimeters. The distribution of A configuration where the two renal pivot fenestration's are at the same level is 57% and the B configuration which is an offset was 43% of the patients.
About 226 mean operative time, slightly more or close to 70 minutes of fluoro time and about one day in the ICU, and three, four days in the hospital. There were two technical problems, the first two patients enrolled at the same site for the trial,
had the p-Branch deployed below the renal arteries due to difficulty with the cannulation and the case done the following day also had a technical failure by not being able to get in a renal. This prompted an update and some physician training and proctoring so that we actually sent proctors to sites,
and the next 28 cases were all successful. Overall, in the feasibility study, 30 day mortality is 0%. Three deaths in the late phase, after 30 days from a cerebral aneurysm. Dissection at slightly less than a year of a proximal
thoracic aneurysm and cardiomyopathy. Freedom from all-cause mortality was 93% in one year, and 89% at 2 years. No ruptures or surgical conversion to date as of last year, when we locked the data. 28 mean follow-up.
Now, if you look at the renal artery patency, which is what all of us are looking at for these types of studies, you see primary patency of stinted renal arteries for this study is on the left. And if you compare that to the initial p-Branch, a single study that was published last year, very similar.
As well as the ZFEN multicenter trial, you see the patencies are quite similar. What about secondary interventions? If you look at this table, we've plotted out secondary interventions at 30 days, and overall, you see the p-Branch feasibility study
slightly higher, but not statistically significant between that and the p-Branch single-center. And the ZFEN is quite low with the 1%. Overall, the secondary interventions were about a third of the patients in most of these studies. Well, what about the pivotal studies?
They said this is an ongoing trial, it's been going on for about three years, we've had about three quarters of the patients enrolled after three years, and we have 28 active sites. We have data on the first 51 patients enrolled, and you see the high enrollers there on the far right.
The mean age is very similar to the feasibility study. 71 years of age, most patients are male, slightly over six centimeters for the diameter, and approximately one millimeter longer at 22 versus 21. The distribution of A and B is also quite similar, as you see here, slightly more A than B,
anywhere from the 55 to 60% range for most all of these studies. Procedures time with the 28 cites now is very similar, 258 minutes, slightly less than the prior study. And you see the fluro time and days in the ICU and discharge very similar.
At 30 days in those 51 patients, no deaths, no renal or bowel ischemia, no neurologic complications or rupture. There had been 3 occlusions of fenestrated vessels, left and renal artery occlusion at day 23, 23, and 30, so these are most likely technical issues
that the stint is crushed. And we've look at that and we'll continue to monitor that. Two patients had re-intervention subsequently, and no patients developed renal insufficiency renal failure at the time of this analysis. So, overall, patient selection, physican technical
abilities, and proper device training will continue to be important for p-Branch implementation and implantation. The feasibility study, early and intermediate results support its safety and feasibility of off-the-shelf device. Follow-up through five years is ongoing. Enrolled is going to continue for the pivotal study
and currently we need less than 20 cases to complete. Thank you.
- Great, thanks Jeff. Welcome everyone. I was actually going to more talk about a wish list for ZFEN plus after some discussion with our industry partners. There's still not quite a final lock yet on the final device so due to various reasons we'll go over kind of a
review of the U.S. fenestrated data and then some of the things that I hope are some of the current limitations. This is our personal experience right now since the approval. 159 commercial ZFEN devices.
Still a reasonable proportion of parallel grafting for urgent or challenging cases. I think everybody acknowledges that obviously creating a seal zone above the renal arteries provides more seal for a standard infrarenal strategy. In fact because the U.S. device the instructions for use
call for a four to 14 millimeter infrarenal neck you wind up adding that in addition to the space that's across the renal arteries as well as the seal generally up to the scallop, or if you're building a large fenestration for the SMA, all the way up to the celiac.
Graft diameters from 22 to 36, the 36 millimeter device being on a 22 French system. The remainder of them being on a 20 French system. Remember that in the U.S. that we can only build three of these holes, if you will, and you can only have two maximum of one of the types meaning the general build
is two small fenestrations for the renals and either a scallop or large fenestration for the superior mesenteric artery. The results of the U.S. prospective trial have been presented and published multiple times in the past but basically in the original study
most of them under general anesthesia. Total amount of procedure time about three to four hours. The device implant time about two hours. Technical success achieved in everyone with all visceral vessels patent on the completion run. 30 day mortality excellent, the one problem
was with bowel ischemia. Major adverse events sort of immediately post op also related to bowel ischemia but no conversion, ruptures, or renal function decline. And at pre-discharge CTA all target vessels patent without any type one or junctional endoleaks.
Hospital stay two to three days. The later follow up paper, follow up out to three years with excellent outcomes related to problems with type one or type three endoleaks and the renal outcomes also excellent. Three patients with renal function deterioration.
But, a reasonable number of renal stent exclusions and stenoses which I do believe should be counted against the technology. And the reninterventions needed in a reasonable number of patients. So a primary patency of 81%
on the Capellan Meyer out to five years. When you look at then sort of early post approval outcomes, which is what we would consider more real world studies, when we looked at the first seven or eight sites that had early access right after approval we looked at this data and it turned out much like
what we would all do if we get our hands on newer technology now. More than two thirds, or just under two thirds of patients actually did not meet the recommended anatomic criteria of a four to 14 millimeter infrarenal neck but despite this the 30 day outcomes
compared to the U.S. data. This is a paper that just came out from the University of Indiana. First hundred patients since the ZFEN approval excellent outcomes but again still a reasonable reintervention rate mainly going after these renal branches.
This was our first one, a very sort of standard infrarenal short neck with a scallop and such built. Most of our builds now are with a large fenestration and bilateral renals. So what do we really need? I think in the newer device.
Well I think everybody wants something that's a little smaller access. We've had to use a reasonable number of both endo and open iliac conduits. I still think the angulation makes things difficult. These cases that have the SMA close to the renals
in the current construct do not allow us to build a device that makes it work for that. We've had to come up with various strategies when the SMA is lower than the higher renal. So I think really the future devices we need to work on the wait time, something with better renal branches
and a smaller access. Thanks.
- Thank you Dr. Asher. What an honor it is to be up here with Dr. Veith and Dr. Asher towards the end. You guys are leading by example being at the end of the meetings. So, thank you for allowing me to be up and talking about something
that not a lot of vascular surgeons have experience with, including me. I have no disclosures. On your left, I have listed some of the types of diseases that we most commonly see in the vertebral artery, and there are quite a lot.
And on the right, the standard types of treatment that we pursue in vascular surgery or as a vascular specialist. And often, in the vertebral artery, if we are going to pursue treatment, it's the endovascular route.
But I'll talk a little bit about open surgery. The clinical presentation is often vague. And the things I wanted to point out here in this long list are things like alternating paresthesias, dysphagia, or perioral numbness may be something in the history to look for
that you may not be thinking about when you're thinking about vertebral basilar disease. The anatomy looks straightforward in this picture, with the four segments, as you can see. It gets a little more complicated with just the arterial system,
but then when you start looking at all these structures, that you have to get out of of the way to get to the vertebral artery, it actually can be a difficult operation, particularly even in the V1 segment. The V1 typically is atherosclerotic disease.
V2 is often compression, via osteophyte or musculo-tendon structures. And V3 and V4, at the top, are typically from a dissection injury from sort of stretch or trauma injury. The pathophysiology isn't that well understood.
You have varying anatomy. It's very difficult to access this artery. Symptoms can be difficult to read, and treatment outcomes are not as reliable. But I'm going to take you through a very quick path through history here in the description
of the V1 segment exposure by Dr. Rentschler from 1958. And I love these pictures. Here is a transverse incision over the sternocleidomastoid, just above the clavicular head on the right side. And once you get the sternoclavicular head divided, you can see the longus colli muscle there.
Anteromedial is the carotid. Of course, you surround that with a Penrose drain. And then once you do that, you can separate your longus colli, and deep to that, the vertebral artery just easily slips right up, so you can do your transposition.
It's not quite that easy. I've done one of these operations, and it was difficult finding t e. And, again, here is on the opposite side, you can see the transposition in this cartoon.
Dr. Berguer is the world's expert, and a lot of this open surgical work comes out of the University of Michigan. Here is a study looking at 369 consecutive extracranial vertebral artery reconstructions. You can see the demographics of clinical presentation.
And note that about 34% of patients are presenting with hemispheric symptoms, with 60% in the vertebral basilar distribution. 300 of these reconstructions were for atherosclerosis. And the outcomes were pretty good. Before 1991, there wasn't really a protocol in place
in assessing and doing these procedures. And you can see the stroke and death rates of 4.1 and 3.2% respectively. And then the outcomes after 1991 are considerably better with a five year patency rate of 80%. So, in summary, vertebral artery disease is,
I think if you review this, is somewhat under diagnosed. Revascularization is a viable option. Most often, it's endovascular. But if you have endo-hostility, then an open, particularly for the V1 segment, may be a better option.
And this requires people with good operative experience. Thank you very much.
- Good morning, thank you, Dr. Veith, for the invitation. My disclosures. So, renal artery anomalies, fairly rare. Renal ectopia and fusion, leading to horseshoe kidneys or pelvic kidneys, are fairly rare, in less than one percent of the population. Renal transplants, that is patients with existing
renal transplants who develop aneurysms, clearly these are patients who are 10 to 20 or more years beyond their initial transplantation, or maybe an increasing number of patients that are developing aneurysms and are treated. All of these involve a renal artery origin that is
near the aortic bifurcation or into the iliac arteries, making potential repair options limited. So this is a personal, clinical series, over an eight year span, when I was at the University of South Florida & Tampa, that's 18 patients, nine renal transplants, six congenital
pelvic kidneys, three horseshoe kidneys, with varied aorto-iliac aneurysmal pathologies, it leaves half of these patients have iliac artery pathologies on top of their aortic aneurysms, or in place of the making repair options fairly difficult. Over half of the patients had renal insufficiency
and renal protective maneuvers were used in all patients in this trial with those measures listed on the slide. All of these were elective cases, all were technically successful, with a fair amount of followup afterward. The reconstruction priorities or goals of the operation are to maintain blood flow to that atypical kidney,
except in circumstances where there were multiple renal arteries, and then a small accessory renal artery would be covered with a potential endovascular solution, and to exclude the aneurysms with adequate fixation lengths. So, in this experience, we were able, I was able to treat eight of the 18 patients with a fairly straightforward
endovascular solution, aorto-biiliac or aorto-aortic endografts. There were four patients all requiring open reconstructions without any obvious endovascular or hybrid options, but I'd like to focus on these hybrid options, several of these, an endohybrid approach using aorto-iliac
endografts, cross femoral bypass in some form of iliac embolization with an attempt to try to maintain flow to hypogastric arteries and maintain antegrade flow into that pelvic atypical renal artery, and a open hybrid approach where a renal artery can be transposed, and endografting a solution can be utilized.
The overall outcomes, fairly poor survival of these patients with a 50% survival at approximately two years, but there were no aortic related mortalities, all the renal artery reconstructions were patented last followup by Duplex or CT imaging. No aneurysms ruptures or aortic reinterventions or open
conversions were needed. So, focus specifically in a treatment algorithm, here in this complex group of patients, I think if the atypical renal artery comes off distal aorta, you have several treatment options. Most of these are going to be open, but if it is a small
accessory with multiple renal arteries, such as in certain cases of horseshoe kidneys, you may be able to get away with an endovascular approach with coverage of those small accessory arteries, an open hybrid approach which we utilized in a single case in the series with open transposition through a limited
incision from the distal aorta down to the distal iliac, and then actually a fenestrated endovascular repair of his complex aneurysm. Finally, an open approach, where direct aorto-ilio-femoral reconstruction with a bypass and reimplantation of that renal artery was done,
but in the patients with atypical renals off the iliac segment, I think you utilizing these endohybrid options can come up with some creative solutions, and utilize, if there is some common iliac occlusive disease or aneurysmal disease, you can maintain antegrade flow into these renal arteries from the pelvis
and utilize cross femoral bypass and contralateral occlusions. So, good options with AUIs, with an endohybrid approach in these difficult patients. Thank you.
- So I'm going to be talking about allografts for peripheral graft infections. This is a femoral artery that's been replaced after a closure device infection and complication, and we've bypassed to the SFA and profunda femoris. These are my disclosures. So peripheral arterial infectious processes,
well the etiology either is primary or secondary. Primary can be from bacteremic states and seeding of ulcerated plaque or thrombus. Secondary reasons for infections can be the vast usage of percutaneous closure devices that really have flooded the market these days.
Prosthetic graft infections after either a bypass or patch in the femoral artery. So early onset infections usually are from break in sterility. Secondary infections can be from either wound breakdowns or late seeding of the prosthetic graft.
The presentation for these patients can be relatively minor such as cellulitis or draining sinus, or much more dramatic, such as sepsis or pseudoaneurysm or mycotic aneurysm. On the CT scan we can see infected mycotic aneurysm after infected closure device and bleeding complications.
The treatment is broad in range. Ligation is obviously one option, but it leads to a very high risk of major limb amputation. So ideally some form of reconstruction, either extra-anatomic through clean planes,
antibiotic graft as we heard from the previous speaker, the use of autologous replacement with deep vein, or we become big proponents of the use of cryopreserved arterial allografts for reconstruction. And much of this stems from our work from about 10 years ago, where we looked
at the use of aortic cryopreserved grafts for aortic graft infections. This was published about 10 years ago but we looked at a small series of patients with aortic infections. You can see the CT scan of an infected stent graft
and associated aneurysm. And then the intraoperative photo after we've resected the stent graft and replaced that segment of the aorta with a cryopreserved aortic segment. So using that as a springboard,
we then decided to look at the outcomes using these types of conduits, arterial conduits, for peripheral arterial reconstructions in contaminated or infected surgical fields. So retrospective review at our tertiary care center, we looked at roughly 60 patients over a 15-year period
and excluded any aortic-based reconstructions. So these are all peripheral reconstructions. Mean follow-up was 28 months. As you would expect, the distribution of treatment zones were primarily in the lower extremities, so 51 cases.
As you can see, there's a list of all the different types of cases that we treated. But then there were a few upper extremity visceral and then carotid. I've shown this slide before at this meeting in the past, with a carotid patch infection
that was treated after it had a blow-out, and it's obviously a infected aneurysm, and this was treated with resection and a cryopreserved arterial segment. Looking at our outcomes, the 30-day outcome showed a mortality rate of 9%.
The 30-day conduit-related complication rate was surprisingly low at 14%. We had four patients that had bleeding complications, four patients with recurrent infectious complications. All eight of those patients required a return back to the operating room for correction.
The late conduit-related complication rate was only 16%. As listed here, you can see there's only one case of reinfection, three cases of graft thrombosis, surprisingly only one major limb amputation, two pseudoaneurysms and one late bleeding complication.
And graphically depicted, you can see here, this area here is looking at the less than 30 days, this is primarily when the complications occur. When you get to six months, fewer complications, and then beyond six months, the primary complications that we would see are either thrombosis of the graft
or the development of late pseudoaneurysms, again relatively low. So in summary, I think peripheral arterial infectious complications can be treated with a cryopreserved arterial allografts. The advantage is it's a single stage operation,
maintains in-line flow, there's a low incidence of repeat infection. I think it's also important to mention that the majority of these patients had adjunctive muscle flap coverage to cover the large soft tissue defect
at the time of the operation. So I think that this is a valuable alternative conduit in a setting of peripheral arterial infections. Thank you.
- Thank you Dr. Albaramum, it's a real pleasure to be here and I thank you for being here this early. I have no disclosures. So when everything else fails, we need to convert to open surgery, most of the times this leads to partial endograft removal,
complete removal clearly for infection, and then proximal control and distal control, which is typical in vascular surgery. Here's a 73 year old patient who two years after EVAR had an aneurism growth with what was thought
to be a type II endoleak, had coiling of the infermius mesenteric artery, but the aneurism continued to grow. So he was converted and what we find here is a type III endoleak from sutures in the endograft.
So, this patient had explantations, so it is my preference to have the nordic control with an endovascular technique through the graft where the graft gets punctured and then we put a 16 French Sheath, then we can put a aortic balloon.
And this avoids having to dissect the suprarenal aorta, particularly in devices that have super renal fixation. You can use a fogarty balloon or you can use the pruitt ballon, the advantage of the pruitt balloon is that it's over the wire.
So here's where we removed the device and in spite of the fact that we tried to collapse the super renal stent, you end up with an aortic endarterectomy and a renal endarterectomy which is not a desirable situation.
So, in this instance, it's not what we intend to do is we cut the super renal stent with wire cutters and then removed the struts individually. Here's the completion and preservation of iliac limbs, it's pretty much the norm in all of these cases,
unless they have, they're not well incorporated, it's a lot easier. It's not easy to control these iliac arteries from the inflammatory process that follows the placement of the endograft.
So here's another case where we think we're dealing with a type II endoleak, we do whatever it does for a type II endoleak and you can see here this is a pretty significant endoleak with enlargement of the aneurism.
So this patient gets converted and what's interesting is again, you see a suture hole, and in this case what we did is we just closed the suture hole, 'cause in my mind,
it would be simple to try and realign that graft if the endoleak persisted or recurred, as opposed to trying to remove the entire device. Here's the follow up on that patient, and this patient has remained without an endoleak, and the aneurism we resected
part of the sack, and the aneurism has remained collapsed. So here's another patient who's four years status post EVAR, two years after IMA coiling and what's interesting is when you do delayed,
because the aneurism sacks started to increase, we did delayed use and you see this blush here, and in this cases we know before converting the patient we would reline the graft thinking, that if it's a type III endoleak we can resolve it that way
otherwise then the patient would need conversion. So, how do we avoid the proximal aortic endarterectomy? We'll leave part of the proximal portion of the graft, you can transect the graft. A lot of these grafts can be clamped together with the aorta
and then you do a single anastomosis incorporating the graft and the aorta for the proximal anastomosis. Now here's a patient, 87 years old, had an EVAR,
the aneurism grew from 6 cm to 8.8 cm, he had coil embolization, translumbar injection of glue, we re-lined the endograft and the aneurism kept enlarging. So basically what we find here is a very large type II endoleak,
we actually just clip the vessel and then resected the sack and closed it, did not remove the device. So sometimes you can just preserve the entire device and just take care of the endoleak. Now when we have infection,
then we have to remove the entire device, and one alternative is to use extra-anatomic revascularization. Our preference however is to use cryo-preserved homograft with wide debridement of the infected area. These grafts are relatively easy to remove,
'cause they're not incorporated. On the proximal side you can see that there's a aortic clamp ready to go here, and then we're going to slide it out while we clamp the graft immediately, clamp the aorta immediately after removal.
And here's the reconstruction. Excuse me. For an endograft-duodenal fistula here's a patient that has typical findings, then on endoscopy you can see a little bit of the endograft, and then on an opergy I series
you actually see extravasation from the duodenal. In this case we have the aorta ready to be clamped, you can see the umbilical tape here, and then take down the fistula, and then once the fistula's down
you got to repair the duodenal with an omental patch, and then a cryopreserved reconstruction. Here's a TEVAR conversion, a patient with a contained ruptured mycotic aneurysm, we put an endovascular graft initially, Now in this patient we do the soraconomy
and the other thing we do is, we do circulatory support. I prefer to use ECMO, in this instances we put a very long canula into the right atrium, which you're anesthesiologist can confirm
with transassof forgeoligico. And then we use ECMO for circulatory support. The other thing we're doing now is we're putting antibiotic beads, with specific antibiotic's for the organism that has been cultured.
Here's another case where a very long endograft was removed and in this case, we put the device offline, away from the infected field and then we filled the field with antibiotic beads. So we've done 47 conversions,
12 of them were acute, 35 were chronic, and what's important is the mortality for acute conversion is significant. And at this point the, we avoid acute conversions,
most of those were in the early experience. Thank you.
- So I'm just going to talk a little bit about what's new in our practice with regard to first rib resection. In particular, we've instituted the use of a 30 degree laparoscopic camera at times to better visualize the structures. I will give you a little bit of a update
about our results and then I'll address very briefly some controversies. Dr. Gelbart and Chan from Hong Kong and UCLA have proposed and popularized the use of a 30 degree laparoscopic camera for a better visualization of the structures
and I'll show you some of those pictures. From 2007 on, we've done 125 of these procedures. We always do venography first including intervascular intervention to open up the vein, and then a transaxillary first rib resection, and only do post-operative venography if the vein reclots.
So this is a 19 year old woman who's case I'm going to use to illustrate our approach. She developed acute onset left arm swelling, duplex and venogram demonstrated a collusion of the subclavian axillary veins. Percutaneous mechanical thrombectomy
and then balloon angioplasty were performed with persistent narrowing at the thoracic outlet. So a day later, she was taken to the operating room, a small incision made in the axilla, we air interiorly to avoid injury to the long thoracic nerve.
As soon as you dissect down to the chest wall, you can identify and protect the vein very easily. I start with electrocautery on the peripheral margin of the rib, and use that to start both digital and Matson elevator dissection of the periosteum pleura
off the first rib, and then get around the anterior scalene muscle under direct visualization with a right angle and you can see that the vein and the artery are identified and easily protected. Here's the 30 degree laparoscopic image
of getting around the anterior scalene muscle and performing the electrocautery and you can see the pulsatile vein up here anterior and superficial to the anterior scalene muscle. Here is a right angle around the first rib to make sure there are no structures
including the pleura still attached to it. I always divide, or try to divide, the posterior aspect of the rib first because I feel like then I can manipulate the ribs superiorly and inferiorly, and get the rib shears more anterior for the anterior cut
because that's most important for decompressing the vein. Again, here's the 30 degree laparoscopic view of the rib shears performing first the posterior cut, there and then the anterior cut here. The portion of rib is removed, and you can see both the artery and the vein
are identified and you can confirm that their decompressed. We insufflate with water or saline, and then perform valsalva to make sure that they're hasn't been any pneumothorax, and then after putting a drain in,
I actually also turn the patient supine before extirpating them to make sure that there isn't a pneumothorax on chest x-ray. You can see the Jackson-Pratt drain in the left axilla. One month later, duplex shows a patent vein. So we've had pretty good success with this approach.
23 patients have requires post operative reintervention, but no operative venous reconstruction or bypass has been performed, and 123 out of 125 axillosubclavian veins have been patent by duplex at last follow-up. A brief comment on controversies,
first of all, the surgical approach we continue to believe that a transaxillary approach is cosmetically preferable and just as effective as a paraclavicular or anterior approach, and we have started being more cautious
about postoperative anticoagulation. So we've had three patients in that series that had to go back to the operating room for washout of hematoma, one patient who actually needed a VATS to treat a hemathorax,
and so in recent times we've been more cautious. In fact 39 patients have been discharged only with oral antiplatelet therapy without any plan for definitive therapeutic anticoagulation and those patients have all done very well. Obviously that's contraindicated in some cases
of a preoperative PE, or hematology insistence, or documented hypercoagulability and we've also kind of included that, the incidence of postop thrombosis of the vein requiring reintervention, but a lot of patients we think can be discharged
on just antiplatelets. So again, our approach to this is a transaxillary first rib resection after a venogram and a vascular intervention. We think this cosmetically advantageous. Surgical venous reconstruction has not been required
in any case, and we've incorporated the use of a 30 degree laparoscopic camera for better intraoperative visualization, thanks.
- 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
- [Speaker] Good morning everybody thanks for attending the session and again thanks for the invitation. These are my disclosures. I will start by illustrating one of the cases where we did not use cone beam CT and evidently there were numerous mistakes on this
from planning to conducting the case. But we didn't notice on the completion of geography in folding of the stent which was very clearly apparent on the first CT scan. Fortunately we were able to revise this and have a good outcome.
That certainly led to unnecessary re intervention. We have looked at over the years our usage of fusion and cone beam and as you can see for fenestrated cases, pretty much this was incorporated routinely in our practice in the later part of the experience.
When we looked at the study of the patients that didn't have the cone beam CT, eight percent had re intervention from a technical problem that was potentially avoidable and on the group that had cone beam CT, eight percent had findings that were immediately revised with no
re interventions that were potentially avoidable. This is the concept of our GE Discovery System with fusion and the ability to do cone beam CT. Our protocol includes two spins. First we do one without contrast to evaluate calcification and other artifacts and also to generate a rotational DSA.
That can be also analyzed on axial coronal with a 3D reconstruction. Which essentially evaluates the segment that was treated, whether it was the arch on the arch branch on a thoracoabdominal or aortoiliac segment.
We have recently conducted a prospective non-randomized study that was presented at the Vascular Annual Meeting by Dr. Tenario. On this study, we looked at findings that were to prompt an immediate re intervention that is either a type one
or a type 3 endoleak or a severe stent compression. This was a prospective study so we could be judged for being over cautious but 25% of the procedures had 52 positive findings. That included most often a stent compression or kink in 17% a type one or three endoleak
in 9% or a minority with dissection and thrombus. Evidently not all this triggered an immediate revision, but 16% we elected to treat because we thought it was potentially going to lead to a bad complication. Here is a case where on the completion selective angiography
of the SMA this apparently looks very good without any lesions. However on the cone beam CT, you can see on the axial view a dissection flap. We immediately re catheterized the SMA. You note here there is abrupt stop of the SMA.
We were unable to catheterize this with a blood wire. That led to a conversion where after proximal control we opened the SMA. There was a dissection flap which was excised using balloon control in the stent as proximal control.
We placed a patch and we got a good result with no complications. But considerably, if this patient was missed in the OR and found hours after the procedure he would have major mesenteric ischemia. On this study, DSA alone would have missed
positive findings in 34 of the 43 procedures, or 79% of the procedures that had positive findings including 21 of the 28 that triggered immediate revision. There were only four procedures. 2% had additional findings on the CT
that were not detectable by either the DSA or cone beam CT. And those were usually in the femoro puncture. For example one of the patients had a femoro puncture occlusion that was noted immediately by the femoro pulse.
The DSA accounts for approximately 20% of our total radiation dose. However, it allows us to eliminate CT post operatively which was done as part of this protocol, and therefore the amount of radiation exposed for the patient
was decreased by 55-65% in addition to the cost containment of avoiding this first CT scan in our prospective protocol. In conclusion cone beam CT has allowed immediate assessment to identify technical problems that are not easily detectable by DSA.
These immediate revisions may avoid unnecessary re interventions. What to do if you don't have it? You have to be aware that this procedure that are complex, they are bound to have some technical mistakes. You have to have incredible attention to detail.
Evidently the procedures can be done, but you would have to have a low threshold to revise. For example a flared stent if the dilator of the relic gleam or the dilator of you bifurcated devise encroach the stent during parts of the procedure. Thank you very much.
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