- Thank you, Ulrich. Before I begin my presentation, I'd like to thank Dr. Veith so kindly, for this invitation. These are my disclosures and my friends. I think everyone knows that the Zenith stent graft has a safe and durable results update 14 years. And I think it's also known that the Zenith stent graft
had such good shrinkage, compared to the other stent grafts. However, when we ask Japanese physicians about the image of Zenith stent graft, we always think of the demo version. This is because we had the original Zenith in for a long time. It was associated with frequent limb occlusion due to
the kinking of Z stent. That's why the Spiral Z stent graft came out with the helical configuration. When you compare the inner lumen of the stent graft, it's smooth, it doesn't have kink. However, when we look at the evidence, we don't see much positive studies in literature.
The only study we found was done by Stephan Haulon. He did the study inviting 50 consecutive triple A patients treated with Zenith LP and Spiral Z stent graft. And he did two cases using a two iliac stent and in six months, all Spiral Z limb were patent. On the other hand, when you look at the iliac arteries
in Asians, you probably have the toughest anatomy to perform EVARs and TEVARs because of the small diameter, calcification, and tortuosity. So this is the critical question that we had. How will a Spiral Z stent graft perform in Japanese EIA landing cases, which are probably the toughest cases?
And this is what we did. We did a multi-institutional prospective observational study for Zenith Spiral Z stent graft, deployed in EIA. We enrolled patients from June 2017 to November 2017. We targeted 50 cases. This was not an industry-sponsored study.
So we asked for friends to participate, and in the end, we had 24 hospitals from all over Japan participate in this trial. And the board collected 65 patients, a total of 74 limbs, and these are the results. This slide shows patient demographics. Mean age of 77,
80 percent were male, and mean triple A diameter was 52. And all these qualities are similar to other's reporting in these kinds of trials. And these are the operative details. The reason for EIA landing was, 60 percent had Common Iliac Artery Aneurysm.
12 percent had Hypogastric Artery Aneurysm. And 24 percent had inadequate CIA, meaning short CIA or CIA with thrombosis. Outside IFU was observed in 24.6 percent of patients. And because we did fermoral cutdowns, mean operative time was long, around three hours.
One thing to note is that we Japanese have high instance of Type IV at the final angio, and in our study we had 43 percent of Type IV endoleaks at the final angio. Other things to notice is that, out of 74 limbs, 11 limbs had bare metal stents placed at the end of the procedure.
All patients finished a six month follow-up. And this is the result. Only one stenosis required PTA, so the six months limb potency was 98.6 percent. Excellent. And this is the six month result again. Again the primary patency was excellent with 98.6 percent. We had two major adverse events.
One was a renal artery stenosis that required PTRS and one was renal stenosis that required PTA. For the Type IV index we also have a final angio. They all disappeared without any clinical effect. Also, the buttock claudication was absorbed in 24 percent of patients at one month, but decreased
to 9.5 percent at six months. There was no aneurysm sac growth and there was no mortality during the study period. So, this is my take home message, ladies and gentlemen. At six months, Zenith Spiral Z stent graft deployed in EIA was associated with excellent primary patency
and low rate of buttock claudication. So we have most of the patients finish a 12 month follow-up and we are expecting excellent results. And we are hoping to present this later this year. - [Host] Thank you.
- 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.
- Our group has looked at the outcomes of patients undergoing carotid-subclavian bypass in the setting of thoracic endovascular repair. These are my obligatory disclosures, none of which are relevant to this study. By way of introduction, coverage of the left subclavian artery origin
is required in 10-50% of patients undergoing TEVAR, to achieve an adequate proximal landing zone. The left subclavian artery may contribute to critical vascular beds in addition to the left upper extremity, including the posterior cerebral circulation,
the coronary circulation if a LIMA graft is present, and the spinal cord, via vertebral collaterals. Therefore the potential risks of inadequate left subclavian perfusion include not only arm ischemia, but also posterior circulation stroke,
spinal cord ischemia, and coronary insufficiency. Although these risks are of low frequency, the SVS as early as 2010 published guidelines advocating a policy of liberal left subclavian revascularization during TEVAR
requiring left subclavian origin coverage. Until recently, the only approved way to maintain perfusion of the left subclavian artery during TEVAR, with a zone 2 or more proximal landing zone, was a cervical bypass or transposition procedure. As thoracic side-branch devices become more available,
we thought it might be useful to review our experience with cervical bypass for comparison with these newer endovascular strategies. This study was a retrospective review of our aortic disease database, and identified 112 out of 579 TEVARs
that had undergone carotid subclavian bypass. We used the standard operative technique, through a short, supraclavicular incision, the subclavian arteries exposed by division of the anterior scalene muscle, and a short 8 millimeter PTFE graft is placed
between the common carotid and the subclavian arteries, usually contemporaneous with the TEVAR procedure. The most important finding of this review regarded phrenic nerve dysfunction. To exam this, all pre- and post-TEVAR chest x-rays were reviewed for evidence of diaphragm elevation.
The study population was typical for patients undergoing TEVAR. The most frequent indication for bypass was for spinal cord protection, and nearly 80% of cases were elective. We found that 25 % of patients had some evidence
of phrenic nerve dysfunction, though many resolved over time. Other nerve injury and vascular graft complications occurred with much less frequency. This slide illustrates the grading of diaphragm elevation into mild and severe categories,
and notes that over half of the injuries did resolve over time. Vascular complications were rare, and usually treated with a corrective endovascular procedure. Of three graft occlusions, only one required repeat bypass.
Two pseudoaneurysms were treated endovascularly. Actuarial graft, primary graft patency, was 97% after five years. In summary then, the report examines early and late outcomes for carotid subclavian bypass, in the setting of TEVAR. We found an unexpectedly high rate
of phrenic nerve dysfunction postoperatively, although over half resolved spontaneously. There was a very low incidence of vascular complications, and a high long-term patency rate. We suggest that this study may provide a benchmark for comparison
with emerging branch thoracic endovascular devices. Thank you.
- 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.
- 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.
- [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.
- So thank you for the kind introduction and thanks for professor Viet for the invitation again this year. So, if we talk about applicability, of course you have to check the eye views from this device and you're limited by few instructions for users. They changed the lengths between the target vessel
and the orifice and the branch, with less than 50 mm , they used to be less than 25 mm. Also keep in mind, that you need to have a distance of more than 67 mm between your renal artery cuff and your iliac bifurcation. The good thing about branch endografts
is that if you have renal artery which comes ... or its orifice at the same level of the SME, you can just advance and put your endorafts a bit more proximally, of course risking more coverage of your aorta and eventually risking high rate
of paraplegia or spinal cord ischemia. Also if your renal artery on one side or if your target vessel is much lower with longer bridging stent grafts which are now available like the VBX: 79 mm or combination of bridging stem grafts, this can be treated as well.
Proximally, we have short extensions like the TBE which only allows 77 or 81 mm. This can also expand its applicability of this device. The suitability has already been proven in.. or assessed by Gaspar and vistas and it came around plus 60%
of all patients with aortic aneurysms. Majority of them are limitations where the previous EVAR or open AAA repair or the narrow diameter reno visceral segment in case of diabetes sections. So, what about the safety of the T-branch device?
We performed an observational study Mister, Hamburg and Milner group and I can present you here the short term results. We looked at 80 patients in prospective or retro prospective manner with the t-branch as instructed for use.
Majority were aneurysms with the type two or type four Crawford tracheal aneurysms, also a few with symptomatic or ruptured cases. Patient characteristics of course, we have the same of the usual high risk cardiovascular profiling,
this group of patients that has been treated. Majority was performed percutaneously in 55%. The procedure time shows us that there is still a learning curve. I think nowadays we can perform this under 200 minutes. What is the outcome?
We have one patient who died post operative day 30, after experiencing multiorgan failure. These are 30 day results. No rupture or conversion to open surgery. We had one patient with cardiac ischemia, seven patients with spinal cord ischemia
and one patient has early branch occlusion. There was both renal arteries were occluded, he had an unknown heparin induced thrombocytopenia and was treated with endovascular thrombectomy and successfully treated as well. Secondary interventions within 30 days were in one patient
stent placement due to an uncovered celiac stent stenosis In one patient there was a proximal type one endoleak with a proximal extension. One patient who had paraplegia or paraparesis, he had a stenosis of his internal iliac artery which stem was stented successfully,
and the paraparesis resolved later on in this patient. And of course the patient I just mentioned before, with his left and right renal artery occlusion. So to conclude, the T-branch has wide applicability as we've seen also before, up to 80% especially with adjuvant procedures.
Longer, more flexible bridging stent grafts will expand the use of this device. Also the TBE proximal extensions allows aortic treatment of diameters for more than 30 mm and I think the limitations are still the diameter at reno visceral segment,
previous EVAR or open AAA repair and having of course multiple visceral arteries. Thank you.
- I'm going to take it slightly beyond the standard role for the VBX and use it as we use it now for our fenestrated and branch and chimney grafts. These are my disclosures. You've seen these slides already, but the flexibility of VBX really does give us a significant ability to conform it
to the anatomies that we're dealing with. It's a very trackable stent. It doesn't, you don't have to worry about it coming off the balloon. Flexible as individual stents and in case in a PTFE so you can see it really articulates
between each of these rings of PTFE, or rings of stent and not connected together. I found I can use the smaller grafts, the six millimeter, for parallel grafts then flare them distally into my landing zone to customize it but keep the gutter relatively small
and decrease the instance of gutter leaks. So let's start with a presentation. I know we just had lunch so try and shake it up a little bit here. 72-year-old male that came in, history of a previous end-to-side aortobifemoral bypass graft
and then came in, had bilateral occluded external iliac arteries. I assume that's for the end-to-side anastomosis. I had a history of COPD, coronary artery disease, and peripheral arterial disease, and presented with a pseudoaneurysm
in the proximal juxtarenal graft anastomosis. Here you can see coming down the thing of most concern is both iliacs are occluded, slight kink in the aortofemoral bypass graft, but you see a common iliac coming down to the hypogastric, and that's really the only blood flow to the pelvis.
The aneurysm itself actually extended close to the renal, so we felt we needed to do a fenestrated graft. We came in with a fenestrated graft. Here's the renal vessels here, SMA. And then we actually came in from above in the brachial access and catheterized
the common iliac artery going down through the stenosis into the hypogastric artery. With that we then put a VBX stent graft in there which nicely deployed that, and you can see how we can customize the stent starting with a smaller stent here
and then flaring it more proximal as we move up through the vessel. With that we then came in and did our fenestrated graft. You can see fenestrations. We do use VBX for a good number of our fenestrated grafts and here you can see the tailoring.
You can see where a smaller artery, able to flare it at the level of the fenestration flare more for a good seal. Within the fenestration itself excellent flow to the left. We repeated the procedure on the right. Again, more customizable at the fenestration and going out to the smaller vessel.
And then we came down and actually extended down in a parallel graft down into that VBX to give us that parallel graft perfusion of the pelvis, and thereby we sealed the pseudoaneurysm and maintain tail perfusion of the pelvis and then through the aortofemoral limbs
to both of the common femoral arteries, and that resolved the pseudoaneurysm and maintained perfusion for us. We did a retrospective review of our data from August of 2014 through March of 2018. We had 183 patients who underwent endovascular repair
for a complex aneurysm, 106 which had branch grafts to the renals and the visceral vessels for 238 grafts. When we look at the breakdown here, of those 106, 38 patients' stents involved the use of VBX. This was only limited by the late release of the VBX graft.
And so we had 68 patients who were treated with non-VBX grafts. Their other demographics were very similar. We then look at the use, we were able to use some of the smaller VBXs, as I mentioned, because we can tailor it more distally
so you don't have to put a seven or eight millimeter parallel graft in, and with that we found that we had excellent results with that. Lower use of actual number of grafts, so we had, for VBX side we only had one graft
per vessel treated. If you look at the other grafts, they're anywhere between 1.2 and two grafts per vessel treated. We had similar mortality and followup was good with excellent graft patency for the VBX grafts.
As mentioned, technical success of 99%, mimicking the data that Dr. Metzger put forward to us. So in conclusion, I think VBX is a safe and a very versatile graft we can use for treating these complex aneurysms for perfusion of iliac vessels as well as visceral vessels
as we illustrated. And we use it for aortoiliac occlusive disease, branch and fenestrated grafts and parallel grafts. It's patency is equal to if not better than the similar grafts and has a greater flexibility for modeling and conforming to the existing anatomy.
Thank you very much for your attention.
- 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.
- 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
- Thank you very much. So this is more or less a teaser. The outcome data will not be presented until next month. It's undergoing final analysis. So, the Vici Stent was the stent in the VIRTUS Trial. Self-expanding, Nitinol stent,
12, 14, and 16 in diameter, in three different lengths, and that's what was in the trial. It is a closed-cell stent, despite the fact that it's closed-cell, the flexibility is not as compromised. The deployment can be done from the distal end
or the proximal end for those who have any interest, if you're coming from the jugular or not in the direction of flow, or for whatever reason you want to deploy it from this end versus that end, those are possible in terms of the system. The trial design is not that different than the other three
now the differences, there are minor differences between the four trials that three completed, one soon to be complete, the definitions of the endpoints in terms of patency and major adverse events were very similar. The trial design as we talked about, the only thing
that is different in this study were the imaging requirements. Every patient got a venogram, an IVUS, and duplex at the insertion and it was required at the completion in one year also, the endpoint was venographic, and those who actually did get venograms,
they had the IVUS as well, so this is the only prospective study that will have that correlation of three different imagings before, after, and at follow-up. Classification, everybody's aware, PTS severity, everybody's aware, the endpoints, again as we talked about, are very similar to the others.
The primary patency in 12 months was define this freedom from occlusion by thrombosis or re-intervention. And the safety endpoints, again, very similar to everybody else. The baseline patient characteristics, this is the pivotal, as per design, there were 170 in the pivotal
and 30 in the feasibility study. The final outcome will be all mixed in, obviously. And this is the distribution of the patients. The important thing here is the severity of patients in this study. By design, all acute thrombotic patients, acute DVT patients
were excluded, so anybody who had history of DVT within three months were excluded in this patient. Therefore the patients were all either post-thrombotic, meaning true chronic rather than putting the acute patients in the post-thrombotic segment. And only 25% were Neville's.
That becomes important, so if you look at the four studies instead of an overview of the four, there were differences in those in terms on inclusion/exclusion criteria, although definitions were similar, and the main difference was the inclusion of the chronics, mostly chronics, in the VIRTUS study, the others allowed acute inclusion also.
Now in terms of definition of primary patency and comparison to the historical controls, there were minor differences in these trials in terms of what that historical control meant. However, the differences were only a few percentages. I just want to remind everyone to something we've always known
that the chronic post-thrombotics or chronic occlusions really do the worst, as opposed to Neville's and the acute thrombotics and this study, 25% were here, 75% were down here, these patients were not allowed. So when the results are known, and out, and analyzed it's important not to put them in terms of percentage
for the entire cohort, all trials need to report all of these three categories separately. So in conclusion venous anatomy and disease requires obviously dedicated stent. The VIRTUS feasibility included 30 with 170 patients in the pivotal cohort, the 12 months data will be available
in about a month, thank you.
- [Doctor] Good morning, thank you Mr. Chairman. Dear colleagues, ladies and gentlemen, I would like to thank Dr. Veith for the very kind invitation and I really apologize for not being able to be able to be here today due to family reasons. These are our disclosures.
And obviously bust opened endovascular repair can fail over time and most commonly this difficult clinical scenario to deal with. Our group and also other institutions have already shown that FEVAR is a feasible technique to repair failed previous open or endovascular repair.
And here we see due to indications of secondary FEVAR. So after previous EVAR the main indication is actually to repair proximal endoleak into different several reasons as for example, into extension of disease over time, or migration, or even poor initial planning to start with. Now over open repair, the two main cases of FEVAR
are basically proximal extension of disease or anastomotic aneurysm for main. So FEVAR is indeed to feasible to repair failed EVAR and open repair. I want us to consider some additional technicalities used. For example, we have as we see here short working length
to work to use pre-existing stent raft or (mumbles) raft of things inside. One way to deal with this issue is to use only a short fenestrated tube and stay on approximately, but if one needs to go all the way down to have a complete relining and sealing, then we can design a bifurcated graft
with an inverted limb which enables us to work also in very short working lengths. And of course, maybe the best thing here is to try to be proactive, using a long body surgical graft during the primary operate. And the same goes for the primary lever procedure.
Using an endograft with a longer body provides a longer working length so second-graft FEVAR repair is needed in the future. Catheterization of the previous stent-graft can be also cumbersome, especially inoculated and nautilus, and also grafts with inner stent-graft.
Our suggestion, actually here, is to use always an inflated balloon, and by withdrawing this inflated balloon, we can easily confirm that we're behind the struts of the stent-graph as we see in the image. Now for oculated anatomy like this,
stretching the previous stent-graft can be also very challenging and how we do this through and through wire, and apply the wired plastic technique, we gain upper access and the femoral access can really helpful to stress aorta and finally enable position of the graft in the desired place.
Now catheterisations target vessels through previous stent-grafts is also not without problems. And as you see here, visualizations of marks is not quite easy due to the pre-existing grafts. So the rotation of this (mumbles) might be helpful in order to make more room for the catheter to follow
when sometimes we have to either catheterise again and again until we finally find a better entry that will enable advancement of the preexisting graphs. Here we see the summary of our experiencing Nuremberg. Up to June of 2018, we have performed a total of 92 secondary FEVAR procedures, 50 after open repair,
and 42 after (mumbles) endovascular. Technical success goes at 96 percent of the patients in the after open repair group, first of 93 percent in after EVAR group, including (mumbles) conversion of the (mumbles) required into seen here technical progress. 30 day mortality was two percent in the after open repair
group, while there was no mortality in the after EVAR group. Now major complications were four percent in the after open repair group, and seven percent in the after EVAR group with most of this complications in the after EVAR group been associated clearly with in comparative technical difficulties.
Finally, if we have a look at the preemptive primary advances, we see a cracked door to more advances over time in the FEVAR after EVAR group compared to FEVAR after open repair group, implying that probably FEVAR's open repair might be more stable background for a secondary FEVAR compared to previous EVAR.
So the concluders summarized their colleagues, ladies and gentleman, FEVAR for failed open and endovascular repair is probably the best option that is technically feasible but one has to consider that additional technical difficulties both in planning and execution. Results appear to be similar after open after
and endovascular repair, but FEVAR after EVAR is clearly more solid in (mumbles). Again, thank you very much, and I apologize for not being here today, thank you.
- These are my disclosures. So central venous access is frequently employed throughout the world for a variety of purposes. These catheters range anywhere between seven and 11 French sheaths. And it's recognized, even in the best case scenario, that there are iatrogenic arterial injuries
that can occur, ranging between three to 5%. And even a smaller proportion of patients will present after complications from access with either a pseudoaneurysm, fistula formation, dissection, or distal embolization. In thinking about these, as you see these as consultations
on your service, our thoughts are to think about it in four primary things. Number one is the anatomic location, and I think imaging is very helpful. This is a vas cath in the carotid artery. The second is th
how long the device has been dwelling in the carotid or the subclavian circulation. Assessment for thrombus around the catheter, and then obviously the size of the hole and the size of the catheter.
Several years ago we undertook a retrospective review and looked at this, and we looked at all carotid, subclavian, and innominate iatrogenic injuries, and we excluded all the injuries that were treated, that were manifest early and treated with just manual compression.
It's a small cohort of patients, we had 12 cases. Eight were treated with a variety of endovascular techniques and four were treated with open surgery. So, to illustrate our approach, I thought what I would do is just show you four cases on how we treated some of these types of problems.
The first one is a 75 year-old gentleman who's three days status post a coronary bypass graft with a LIMA graft to his LAD. He had a cordis catheter in his chest on the left side, which was discovered to be in the left subclavian artery as opposed to the vein.
So this nine French sheath, this is the imaging showing where the entry site is, just underneath the clavicle. You can see the vertebral and the IMA are both patent. And this is an angiogram from a catheter with which was placed in the femoral artery at the time that we were going to take care of this
with a four French catheter. For this case, we had duel access, so we had access from the groin with a sheath and a wire in place in case we needed to treat this from below. Then from above, we rewired the cordis catheter,
placed a suture-mediated closure device, sutured it down, left the wire in place, and shot this angiogram, which you can see very clearly has now taken care of the bleeding site. There's some pinching here after the wire was removed,
this abated without any difficulty. Second case is a 26 year-old woman with a diagnosis of vascular EDS. She presented to the operating room for a small bowel obstruction. Anesthesia has tried to attempt to put a central venous
catheter access in there. There unfortunately was an injury to the right subclavian vein. After she recovered from her operation, on cross sectional imaging you can see that she has this large pseudoaneurysm
coming from the subclavian artery on this axial cut and also on the sagittal view. Because she's a vascular EDS patient, we did this open brachial approach. We placed a stent graft across the area of injury to exclude the aneurism.
And you can see that there's still some filling in this region here. And it appeared to be coming from the internal mammary artery. We gave her a few days, it still was patent. Cross-sectional imaging confirmed this,
and so this was eventually treated with thoracoscopic clipping and resolved flow into the aneurism. The next case is a little bit more complicated. This is an 80 year-old woman with polycythemia vera who had a plasmapheresis catheter,
nine French sheath placed on the left subclavian artery which was diagnosed five days post procedure when she presented with a posterior circulation stroke. As you can see on the imaging, her vertebral's open, her mammary's open, she has this catheter in the significant clot
in this region. To manage this, again, we did duel access. So right femoral approach, left brachial approach. We placed the filter element in the vertebral artery. Balloon occlusion of the subclavian, and then a stent graft coverage of the area
and took the plasmapheresis catheter out and then suction embolectomy. And then the last case is a 47 year-old woman who had an attempted right subclavian vein access and it was known that she had a pulsatile mass in the supraclavicular fossa.
Was noted to have a 3cm subclavian artery pseudoaneurysm. Very broad base, short neck, and we elected to treat this with open surgical technique. So I think as you see these consults, the things to factor in to your management decision are: number one, the location.
Number two, the complication of whether it's thrombus, pseudoaneurysm, or fistula. It's very important to identify whether there is pericatheter thrombus. There's a variety of techniques available for treatment, ranging from manual compression,
endovascular techniques, and open repair. I think the primary point here is the prevention with ultrasound guidance is very important when placing these catheters. Thank you. (clapping)
- These are my disclosures. So aortic neck dilatation is not a new problem. It's been described even before the era of endovascular repair and it's estimated to occur in about 20% of all patients that undergo EVAR two years after the index procedure.
We're seeing more and more cases where patients that survive long enough after EVAR, they develop aortic neck dilatation beyond the nominal diameter of the endograft and like on this patient, this image, large type 1A endoleaks that are difficult to treat.
There's a number of factors that are contributing to aortic neck dilatation including a continuous outward force that is exerted by the endograft. Progression of aortic wall degeneration. Aneurisymal disease is a degenerative procedure.
The presence of endoleaks, particularly type two endoleaks have been implicated in aortic neck dilatation. And then incomplete seal at the proximal neck in the form of microleaks or positional leaks. HeliFX EndoAnchors as you heard were
designed to stabilize and improve the apposition of the endograft to the aortic neck. And as you saw on this video, their presence even when the super no fixation disengages from the wall of the aorta, may help stabilize the graft onto
the aorta and prevent type 1A endoleaks. About three or four years ago we started looking at the anchor registry data, trying to identify predictors of aortic neck dilatation in patients who are undergoing EVAR with EndoAnchors. We published those results about a year ago.
In terms of the one year mark, we had 267 patients in that cohort. We measured the aortic diameter at four different levels. 20 millimeters proximal to the lowest main renal artery and then at the level of the lowest renal artery, five and 10 millimeters distal to that.
We defined the change in diameter that occurred between the pre-implantation EVAR and the first post-implantation EVAR at about one month. As adoptive enlargement due mainly to the effect of endograaft and the interaction with the aortic wall.
And then we defined this dilatation, what occurred between the one month and the 12 month mark, post EVAR. We used 20 different variables and we ran all these variables at the three levels. And what we found in terms of
post-operative neck dilatation is that it occurred in 3.1% of patients at the level of the lowest renal artery. 7.7% five millimeters distal to it and 4.6% at 10 millimeters distal to it. And this is a dilatation with a threshold
of at least three millimeters. We felt that this was much more clinically relevant. In terms of protective factors for adaptive enlargement, the presence of calcium and the aortic diameter of the level of the lowest renal, both of these are easy to understand.
The stiffer the aorta, the lesser the degree of the immediate dilatation. But then when we looked at the true dilatation, we found out that the aortic neck diameter at the lowest renal artery was a significant risk factor as was Endograft oversizing.
So if you started with a large aorta to begin with, these patients were much more likely to develop neck dilatation and if you significantly oversize the endograft that was also an independent risk factor. On the other hand, the neck length as well as the number of EndoAnchors that
were placed in these patients, both appear to have independent protective effects. So the two year preliminary analysis results is what I'm going to present. The analysis is still ongoing, but now we have a larger number of patients, 674.
We performed the same measurements at the same levels. What we found in terms of time course and location of the aortic neck dilatation is that in the suprarenal site, there is negligible dilatation up to 24 months. The largest dilatation occurs at five millimeters,
but more interestingly, a significant number of patients did not even have endograft present in that location. And then at 10 millimeters distal to the lowest renal artery right where most of the aneurysm changes you would expect to occur,
that change in diameter was again negligible. Indirectly suggesting that EndoAnchors have protective effect. So these are our interesting, some interesting insights. Female sex and graft oversize do play a significant role in the post-operative neck dilatation.
With EndoAnchors implanted at the index procedure neck dilatation 10 millimeters distal to the lowest renal artery appears to be negligible both at 12 and at 24 months. But we're working to see a little bit more finer elements at this analysis.
As where exactly the EndoAnchors were placed and how this was associated with the changes in the aortic neck. We hope to have those results later this year. Thank you.
- 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.
- Good afternoon, I'd like to thank the moderators and Dr. Veith for inviting me to discuss our experience with using coronary drug eluting stents to salvage failed or failing vein grafts. Vein graft stenosis is the major cause of delayed graft failure after infrainguinal bypass.
It affects one-third of bypasses and reduces primary patency. Obviously the gold standard is open revision, but there isn't always conduit for that. It requires a general anesthesia. The result of endovascular interventions
have been largely disappointing. In particular, conventional peripheral stents are way too large to treat most saphenous vein bypass grafts. Coronary drug eluting stents are a better match from a size standpoint
to saphenous vein bypass grafts and they have a mechanical advantage, or many mechanical advantages over balloons, especially with regard to watermelon seeding. The scaffold of the stent prevents the balloon from slipping proximately
or distally when your dilating the stent. Finally, the mechanism of vein graft stenosis, especially at anastomoses, is neointimal hyperplasia, so the drug eluding stent is rational and obviously it's been proven in saphenous vein grafts used for
coronary artery bypass grafting when compared to angioplasty and bare metal stenting. So this is a case of proximal stenosis of a bypass graft arising from the femoral artery, which we treated with a balloon mounted coronary drug eluting stent
with an excellent technical result. We retrospectively looked at our experience doing this from 2012 to 2017 and we looked at the following outcomes. Primary stenosis-free patency, assisted graft patency, graft occlusion,
amputation, and then I'll talk about this briefly, comparison to standard endovascular interventions on the same patients in the same bypasses. We put 21 drug eluting coronary stents and 19 lesions in 17 patients bypasses. All of these bypasses were either
baloney popliteal bypasses or tibial bypasses using saphenous vein bypass graft. The lesions were most likely or most often just distal to the proximal anastomosis or at the proximal anastomosis, although three of them were at the distal anastomosis.
Twelve of them were performed after failure of angioplasty at the same operative setting. The others were performed as a primary intervention in a single setting. Operative technical success was 100%, primary stenosis-free patency
and assisted graft patency were good at six months and declined from there, as you might expect. Five patients occluded their grafts during follow up and that resulted in four amputations, but twelve bypasses, or 70%, were still open at the end of the follow up.
We compared the 21 coronary drug eluting stent interventions to 23 more standard endovascular interventions for lesions of saphenous vein bypass grafts. When we compared the two approaches for all lesions, we didn't see any difference in primary stenosis-free patency
between the coronary drug eluting stents and the more standard endovascular interventions. Similarly, for recurrent lesions we didn't see any difference. But for primary treatment of initial lesions in saphenous vein bypass grafts,
there was better primary stenosis-free patency for the coronary drug eluting stents then for the standard endovascular interventions. So a couple of caveats. This is a single institution experience, it's a small sample size.
However for these tough lesions threatening bypass grafts, we saw that the majority of coronary drug eluting stents placed after immediate PTA failure were technically successful. Half of them were placed for recurrent lesions
and we did see a kind of patency that was at least comparable to standard vascular interventions. Here's a woman who was in a lot of trouble when she originally came to us. She had had bilateral knee arthroplasties
with a tourniquet, but she had popliteal aneurysms bilaterally that the orthopedic surgeon didn't recognize. So she thrombosed both her popliteal aneurysms. She only had enough conduit for a bypass on one side
so she got an above knee amputation on the other side. But the one side had kind of a not so great of saphenous vein and not so great of perineal artery, but we performed the bypass
and I then had to intervene on this bypass graft a number of times to keep it patent. And here you can see a stenosis at our distal anastomosis and some disease in her perineal artery that we treated with a drug eluting coronary stent
with an excellent technical result and this leg is still attached and she's walking. So again, in a small cohort at a single institution, I think this experience demonstrates that coronary drug eluting stents
provide durability at least comparable to standard endovascular interventions for the treatment of infrainguinal bypass graph stenosis that threaten bypasses and coronary drug eluting stents definitely performed better than
standard endovascular interventions in initial lesions. I think these results warrant further clinical investigation. Thanks.
- 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)
- [Narrator] Good morning everyone. Again, thank you Dr. Veith for inviting me for this legendary meeting. I just love your meeting, thank you very much. Here you have my disclosures, I have said that the T-Branch device from Cook is not commercialized in the US
but it is in South America, now it's in Europe. Our presentation today is based in our article published German Vascular Therapy last year in August, Advanced technical considerations for implanting the T-branch off the shelf.
Branches stent-graft to treat Thoracoabdominal Aneurysms. I'm sure most of you already know this device. It's a off the shelf device from Cook. It has 202 millimeters in length. The proximal stent is 34 millimeters, the distal stent is 18 millimeters.
Of course, it has also four downward branch, so you have to adapt the anatomy of your patient and then to use this device in many situations. Here is a simple example, you can use this device in perirenal or superrenal aneurysms type 4. Just cutting one or two of the proximal stents.
Just be aware to (mumbles) the device in the (mumbles). So you can avoid the migration of the device. That's a good way to diminish the risks of paraplegia for you patient. The same way you can now cut the distal portion one or two stents, so and in cases you have
a previous device, you can pipe one in the leak, is we can show in cases, maxes lights, you can use this device. Also, the second component to anybody of the device, the bifurcated component can be cut. You can cut the proximal stents, you can cut
the distal stents, you can make that straight graft. So just like that, use it in many circumstances. And this is one of the maneuvers we use very often. We call that device driven by the sheath because you do a through and through wire and then you put that set the nose of our device
inside the sheath that come from the arm. So it helps by the avoid your device to touch the aort wall or even devices previously inserted. And also allow you to rotate the device to a correct position. Another maneuver is snare-ride technique that
we have already described in the Journal Endovascular Therapy last year. It's a very simple way so we can bring from the femoral access, we can bring the snare inside the one artery and that snare can capture a wire come from the arm, so we can
hold the position inside the target vessel. Here, an example that you can see all those maneuvers. This patient has a previous I-stent surgery and then the device that is probably the false lumen all the vessels come from this true lumen, which is secluded like capsule decortication.
They have minimal aortic communication. They've going to seen more details in the next slides. So here you can see the case that is a communication close to the celiac track and then is stuck. And then you have another communication, the intrarenal aort are very thin.
So here is a draw, you can see the first challenge was could we move a sheath, 12 branch sheath across the (mumbles) in the thin aorta and put that in the thin aorta, so without that, we could not do the case. We start the case doing that and as you can see,
we see that it was possible to do that, so we continue in the case. Following are challenges you will face was would we be able to cross this aort, very thin channel and to go there, to put the device here, and then to put the t-branch device to
all the branches from this true lumen. So here is our study, our plan was if you cross that communication, we put a t-branch here and used the celiac branch to TAAAs. Left renal artery, the celiac branch, the mysentary to branch the celiac artery, the left renal branch
to the mysentary artery and then right renal branch to right renal branch. So, that proves to be feasible. We could graft that communication and that adversary straight device to start the (cuts off). So here you see that the things
happened exactly as we planned it. The celiac was done by the SMA branch, the SMA done by the left renal, and the right renal by the right renal. At that point, we consider the game over. (cuts off) who could try the
celiac branch to the left renal. The angle was not preferable, so we come from the femoral artery in have access to left renal and open (mumbles) there and the diverse that wire should be put inside the left renal. Here you see the maneuver completed.
We advanced and hold the stent so we can have this branch also done. Here, you have a closed view of the left renal branch done by the celiac branch of the device. And now we have the final result of the branch done. How the bifurcate the device of completely
excluding the false movement of this complex dissection. So to illustrate this presentation, I bring you the control, one week control of this patient and could we fold the breasts where (mumbles) did it in the dissection, totally excluded from the circulation.
So, in conclusion ladies and gentlemen, I would say that the use of the branched stent-grafts in the treatment of Thoracoabdominal use is proven feasible, safe, and the off-the-shelf multibranched t-branch can be used in both urgent and elective scenarios.
Employing adjunctive maneuvers can increase the anatomic suitability of rience, these techniques have increased the applicability to 80 percent of the cases, included dissections of the small lumen.
I want to thank you all for your kind attention. Thank you, again, Frank for accepting my talk recorded. And I'm very pleased to answer questions by email or WhatsApp as you can see, this is live. Thank you very much.
- So, my topic today is: Antegrade In Situ Fenestration for Fenestrated EVAR: How To Do It. Here are my disclosures. So, Jean Panneton has shown already the validity of retrograde laser fenestration. That is a feasible technique,
an effective option for acute thoracic pathology, with an excellent midterm patency, which it is very easy to do retrograde laser fenestration compared to an anterograde technique. We have done a lot of bench tests to perform all like this (mumbles).
So, the in situ laser fenestration technique is an off-label procedure. It is a bailout solution, and dedicated to emergent cases, patient unfit to open repair, or unfit to CMD device.
And we use this technique for left subclavian arch, and the anterograde technique for visceral arteries, and in a few cases of TEVAR. This is a technique. I use a Heli-FX 16 French. And I use
a 0.9 laser probe. We don't need to use another laser probe for this technique to avoid any larger hole. This is the steps for the technique. I do a primary stenting of the arteries using your effusion.
And then I do the endovascular exclusion. I position the steerable sheath at the level of the targeted artery and then do laser fenestration. This is a pre-stenting. And then the graft deployment
at the level of the seating zone. This was a type 1A endoleak after EVAR. The next step is to do the laser fenestration. You can see the tip of the laser probe. (Mumbles)
You could see the tip of the laser probe coming in the lumen of the SMA. And, we'll then, after this laser fenestration, quite easy, we'll then do
an enlargement of the ULL, using first a small cutting balloon and then do a progressive dilation using a bigger balloon, four millimeter, and then a six millimeter balloon.
The next step is to do, like, what we do for fenestrated cases, we do the bridging covered stent. Yeah, at the level of the SMA, and then the flairing, to have a good sealer
of the proximal part of the bridging stent. After the SMA, we then do the renal fenestration. And we used to stop with the celiac trunk. Our main indications are juxta para renal aneurysm, or type 1A Endoleak when there is a straight aorta. And in a few cases, thoracoabdominal aortic aneurysms.
This is an example of a type 1A endoleak, as I have presented. This is our first trial with 16 patients, treated on between three years. And we have now 29 patients with laser fenestration EVAR,
66 fenestrations, 5% of aortic aneurysm treated in our center. The median ischemic time is 12 minutes for the SMA, one hour for the renal arteries, and around two hours for the celiac trunk. The fenestration success rate is 95%.
Here are the outcomes. There was no mortality, even for very old patients. 16% of transitory dialysis. No spinal cord ischemia, one case of pneumonia, and the short follow-up of 22 months with 24 re-operations
in seven patients. Here are my conclusion. The laser fenestration EVAR must not be used for elective cases. In our strategy, the best options for urgent thoracoabdominal is to use
an off-the-shelf graft, like the T-branch. If a custom-made device graft is not available, the laser fenestration will be our reference treatment, and you don't need any brachial or axillary approach for this technique. Thank you very much.
- Thank you Mr. Chairman. Ladies and gentleman, first of all, I would like to thank Dr. Veith for the honor of the podium. Fenestrated and branched stent graft are becoming a widespread use in the treatment of thoracoabdominal
and pararenal aortic aneurysms. Nevertheless, the risk of reinterventions during the follow-up of these procedures is not negligible. The Mayo Clinic group has recently proposed this classification for endoleaks
after FEVAR and BEVAR, that takes into account all the potential sources of aneurysm sac reperfusion after stent graft implant. If we look at the published data, the reported reintervention rate ranges between three and 25% of cases.
So this is still an open issue. We started our experience with fenestrated and branched stent grafts in January 2016, with 29 patients treated so far, for thoracoabdominal and pararenal/juxtarenal aortic aneurysms. We report an elective mortality rate of 7.7%.
That is significantly higher in urgent settings. We had two cases of transient paraparesis and both of them recovered, and two cases of complete paraplegia after urgent procedures, and both of them died. This is the surveillance protocol we applied
to the 25 patients that survived the first operation. As you can see here, we used to do a CT scan prior to discharge, and then again at three and 12 months after the intervention, and yearly thereafter, and according to our experience
there is no room for ultrasound examination in the follow-up of these procedures. We report five reinterventions according for 20% of cases. All of them were due to endoleaks and were fixed with bridging stent relining,
or embolization in case of type II, with no complications, no mortality. I'm going to show you a couple of cases from our series. A 66 years old man, a very complex surgical history. In 2005 he underwent open repair of descending thoracic aneurysm.
In 2009, a surgical debranching of visceral vessels followed by TEVAR for a type III thoracoabdominal aortic aneurysms. In 2016, the implant of a tube fenestrated stent-graft to fix a distal type I endoleak. And two years later the patient was readmitted
for a type II endoleak with aneurysm growth of more than one centimeter. This is the preoperative CT scan, and you see now the type II endoleak that comes from a left gastric artery that independently arises from the aneurysm sac.
This is the endoleak route that starts from a branch of the hepatic artery with retrograde flow into the left gastric artery, and then into the aneurysm sac. We approached this case from below through the fenestration for the SMA and the celiac trunk,
and here on the left side you see the superselective catheterization of the branch of the hepatic artery, and on the right side the microcatheter that has reached the nidus of the endoleak. We then embolized with onyx the endoleak
and the feeding vessel, and this is the nice final result in two different angiographic projections. Another case, a 76 years old man. In 2008, open repair for a AAA and right common iliac aneurysm.
Eight years later, the implant of a T-branch stent graft for a recurrent type IV thoracoabdominal aneurysm. And one year later, the patient was admitted again for a type IIIc endoleak, plus aneurysm of the left common iliac artery. This is the CT scan of this patient.
You will see here the endoleak at the level of the left renal branch here, and the aneurysm of the left common iliac just below the stent graft. We first treated the iliac aneurysm implanting an iliac branched device on the left side,
so preserving the left hypogastric artery. And in the same operation, from a bowl, we catheterized the left renal branch and fixed the endoleak that you see on the left side, with a total stent relining, with a nice final result on the right side.
And this is the CT scan follow-up one year after the reintervention. No endoleak at the level of the left renal branch, and nice exclusion of the left common iliac aneurysm. In conclusion, ladies and gentlemen, the risk of type I endoleak after FEVAR and BEVAR
is very low when the repair is planning with an adequate proximal sealing zone as we heard before from Professor Verhoeven. Much of reinterventions are due to type II and III endoleaks that can be treated by embolization or stent reinforcement. Last, but not least, the strict follow-up program
with CT scan is of paramount importance after these procedures. I thank you very much for your attention.
- Thank you (mumbles) and thank you Dr. Veith for the kind invitation to participate in this amazing meeting. This is work from Hamburg mainly and we all know that TEVAR is the first endovascular treatment of choice but a third of our patients will fail to remodel and that's due to the consistent and persistent
flow in the false lumen over the re-entrance in the thoracoabdominal aorta. Therefore it makes sense to try to divide the compartments of the aorta and try to occlude flow in the false lumen and this can be tried by several means as coils, plug and glue
but also iliac occluders but they all have the disadvantage that they don't get over 24 mm which is usually not enough to occlude the false lumen. Therefore my colleague, Tilo Kolbel came up with this first idea with using
a pre-bulged stent graft at the midportion which after ballooning disrupts the dissection membrane and opposes the outer wall and therefore occludes backflow into the aneurysm sac in the thoracic segment, but the most convenient
and easy to use tool is the candy-plug which is a double tapered endograft with a midsegment that is 18 mm and once implanted in the false lumen at the level of the supraceliac aorta it occludes the backflow in the false lumen in the thoracic aorta
and we have seen very good remodeling with this approach. You see here a patient who completely regressed over three years and it also answers the question how it behaves with respect to true and false lumen. The true lumen always wins and because once
the false lumen thrombosis and the true lumen also has the arterial pressure it does prevail. These are the results from Hamburg with an experience of 33 patients and also the international experience with the CMD device that has been implanted in more than 20 cases worldwide
and we can see that the interprocedural technical success is extremely high, 100% with no irrelevant complications and also a complete false lumen that is very high, up to 95%. This is the evolvement of the candy-plug
over the years. It started as a surgeon modified graft just making a tie around one of the stents evolving to a CMD and then the last generation candy-plug II that came up 2017 and the difference, or the new aspect
of the candy-plug II is that it has a sleeve inside and therefore you can retrieve the dilator without having to put another central occluder or a plug in the central portion. Therefore when the dilator is outside of the sleeve the backflow occludes the sleeve
and you don't have to do anything else, but you have to be careful not to dislodge the whole stent graft while retrieving the dilator. This is a case of a patient with post (mumbles) dissection.
This is the technique of how we do it, access to the false lumen and deployment of the stent graft in the false lumen next to the true lumen stent graft being conscious of the fact that you don't go below the edge of the true lumen endograft
to avoid (mumbles) and the final angiography showing no backflow in the aneurysm. This is how we measure and it's quite simple. You just need about a centimeter in the supraceliac aorta where it's not massively dilated and then you just do an over-sizing
in the false lumen according to the Croissant technique as Ste-phan He-lo-sa has described by 10 to 30% and what is very important is that in these cases you don't burn any bridges. You can still have a good treatment
of the thoracic component and come back and do the fenestrated branch repair for the thoracoabdominal aorta if you have to. Thank you very much for your attention. (applause)
- The committee asked me to give an update on the Cook p-Branch device which is in a clinical trial in the United States. This is the disclosures as it relates to this talk. I'm going to discuss the feasibility as well as the pivotal study as you see on this slide. Now these two studies, as you can imagine,
have a different number of patients. The feasibility study was done in 30 patients and, as all studies in the U.S., required a five-year follow-up. And the p-Branch pivotal study is involving 82 patients with also a five-year follow-up, with the objectives really to assess the device's
safety and effectiveness and primary endpoints, treatment at one year. Now, the feasibility study enrolled 30 patients at 10 U.S. sites over a two and a half year period, roughly. So here the mean age was 73 years and maximum aneurysm diameter's 65 millimeters
and proximal neck length with the enrolled patients was 21 millimeters. The distribution of A configuration where the two renal pivot fenestration's are at the same level is 57% and the B configuration which is an offset was 43% of the patients.
About 226 mean operative time, slightly more or close to 70 minutes of fluoro time and about one day in the ICU, and three, four days in the hospital. There were two technical problems, the first two patients enrolled at the same site for the trial,
had the p-Branch deployed below the renal arteries due to difficulty with the cannulation and the case done the following day also had a technical failure by not being able to get in a renal. This prompted an update and some physician training and proctoring so that we actually sent proctors to sites,
and the next 28 cases were all successful. Overall, in the feasibility study, 30 day mortality is 0%. Three deaths in the late phase, after 30 days from a cerebral aneurysm. Dissection at slightly less than a year of a proximal
thoracic aneurysm and cardiomyopathy. Freedom from all-cause mortality was 93% in one year, and 89% at 2 years. No ruptures or surgical conversion to date as of last year, when we locked the data. 28 mean follow-up.
Now, if you look at the renal artery patency, which is what all of us are looking at for these types of studies, you see primary patency of stinted renal arteries for this study is on the left. And if you compare that to the initial p-Branch, a single study that was published last year, very similar.
As well as the ZFEN multicenter trial, you see the patencies are quite similar. What about secondary interventions? If you look at this table, we've plotted out secondary interventions at 30 days, and overall, you see the p-Branch feasibility study
slightly higher, but not statistically significant between that and the p-Branch single-center. And the ZFEN is quite low with the 1%. Overall, the secondary interventions were about a third of the patients in most of these studies. Well, what about the pivotal studies?
They said this is an ongoing trial, it's been going on for about three years, we've had about three quarters of the patients enrolled after three years, and we have 28 active sites. We have data on the first 51 patients enrolled, and you see the high enrollers there on the far right.
The mean age is very similar to the feasibility study. 71 years of age, most patients are male, slightly over six centimeters for the diameter, and approximately one millimeter longer at 22 versus 21. The distribution of A and B is also quite similar, as you see here, slightly more A than B,
anywhere from the 55 to 60% range for most all of these studies. Procedures time with the 28 cites now is very similar, 258 minutes, slightly less than the prior study. And you see the fluro time and days in the ICU and discharge very similar.
At 30 days in those 51 patients, no deaths, no renal or bowel ischemia, no neurologic complications or rupture. There had been 3 occlusions of fenestrated vessels, left and renal artery occlusion at day 23, 23, and 30, so these are most likely technical issues
that the stint is crushed. And we've look at that and we'll continue to monitor that. Two patients had re-intervention subsequently, and no patients developed renal insufficiency renal failure at the time of this analysis. So, overall, patient selection, physican technical
abilities, and proper device training will continue to be important for p-Branch implementation and implantation. The feasibility study, early and intermediate results support its safety and feasibility of off-the-shelf device. Follow-up through five years is ongoing. Enrolled is going to continue for the pivotal study
and currently we need less than 20 cases to complete. Thank you.
- Thank you very much indeed, Chairman. Ladies and gentleman, thank you very much for the podium. Right, my opponent Professor Hogan, has just given his statement asking you to abandon two fenestrated endovascular repairs in favor of three and four fenestrations, but this picture proves to you that during his spare time,
he's actively promoting single fenestration devices, actually. Just keep that in mind. My contention is that three and four branch fenestrated EVARs result in higher complications and higher mortality, which means that they should be avoided if at all possible.
What exactly are the critical issues that are at question here? Do four fenestrated endovascular repairs carry higher risk of complications compared to simpler devices? If they do, are the worth it? However, my opponent is also one of the world's
experts in this area. We've definitely learned quite a lot from him in the early stage of our program about 10-13 years ago. So, he usually has something sensible to say, has he got a point? My plan for this debate is to give you a very balanced view
based on multicenter data. Don't forget, the very compelling data Eric showed you are his single-center series. It is not easy to replicate his results in most other centers. I also would like to keep the debate clean.
Now, coming to the facts, four fenestrated repairs, beyond a doubt, just take more operating time than simpler devices. They're also technically one of the most challenging of aneurysm repairs that you do. They do test your center and team's experience.
Definitely in extricating oneself from intra-operator difficulties, and also, experience gives you the confidence through the operation that you will see the day through. It's also the case that the greater length of aorta is covered by stent graft fabric,
the more lumbars are taken, compromising the spinal cord blood supply further, which is a significant factor. This is a multicenter series from UK, from Terumo Aortic, their Anaconda Fenestrated platform multicenter series of their first 101 devices.
You notice that when the seals are extended to above celiac axis, which means four fenestrated devices, they had a much higher mortality compared to simpler devices. There's also the British Society of Endovascular Therapies Globalstar registry, which I run, currently has got
just over 850 patients registered, and we had data adequate for analysis in 533 patients. Being a much more spread out multicenter series, the results are worse. And you notice that three and four fenestrated devices in this pragmatic multicenter nationwide series
have got a much higher, substantially higher, death rate compared to simpler devices, which is statistically significant. In the long run, up to about four to five years, you notice that four fenestrated do carry a higher, slightly higher risk of re-intervention,
but the overall mortality is not hugely different. The numbers do dwindle. There are very few numbers up to ten years. So, it's not worth looking after 40 years of research. Paraplegia, the Globalstar registry had a total of six paraplegia occurrences reported.
Five of those are in patients who had four fenestrated devices put in. This is definitely worth remembering. It is a complication that really sinks you hard. So, in conclusion, the complexity of device should actually not be compared
without the context of anatomy. Frequently, to get an adequate and durable seal, you do need four fenestrations. However, remember, multicenter series do conclusively show that four fenestrateds are definitely more dangerous compared to the simpler of the devices.
However, this increased risk has to be compared against the perceived risk of alternative treatments such as open repair. So to conclude, Chairman, ladies and gentlemen, the primary aim of fenestrated repair is actually to achieve satisfactory seal zone, which I would say,
which I would say probably at least 20 millimeters of aorta, which is relatively free from calcification or thrombus. That is the bare minimum we should be looking at to get a durable seal. While that is the primary concern, and we need to incorporate as many number of fenestrations
as are technically required depending on your platform that you wish to use. The number of fenestrations themselves are, in fact, secondary and less important. However, if you are able to achieve such a good durable seal without using three or four fenestrations,
more complex devices are certainly not worth it. Thank you very much for your attention.
- Thank you Mr Chairman, ladies and gentlemen. These are my disclosure. Open repair is the gold standard for patient with arch disease, and the gupta perioperative risk called the mortality and major morbidity remain not negligible.
Hybrid approach has only slightly improved these outcomes, while other off-the-shelf solution need to be tested on larger samples and over the long run. In this scenario, the vascular repair would double in the branch devices as emerging, as a tentative option with promising results,
despite addressing a more complex patient population. The aim of this multi-center retrospective registry is to assess early and midterm results after endovascular aortic arch repair. using the single model of doubling the branch stent graft in patient to fit for open surgery.
All patient are treated in Italy, with this technique. We're included in this registry for a total of 24 male patient, fit for open surgery. And meeting morphological criteria for double branch devices.
This was the indication for treatment and break-down by center, and these were the main end points. You can see here some operative details. Actually, this was theo only patient that did not require the LSA
re-revascularization before the endovascular procedure, because the left tibial artery rising directly from the aortic arch was reattached on the left common carotid artery. You can see here the large window in the superior aspect of the stent graft
accepting the two 13 millimeter in the branches, that are catheterized from right common carotid artery and left common carotid artery respectively. Other important feature of this kind of stent graft is the lock stent system, as you can see, with rounded barbs inside
the tunnels to prevent limb disconnection. All but one patient achieved technical success. And two of the three major strokes, and two retrograde dissection were the cause of the four early death.
No patient had any type one or three endoleak. One patient required transient dialysis and four early secondary procedure were needed for ascending aorta replacement and cervical bleeding. At the mean follow-up of 18 months,
one patient died from non-aortic cause and one patient had non-arch related major stroke. No new onset type one or three endoleak was detected, and those on standard vessel remained patent. No patient had the renal function iteration or secondary procedure,
while the majority of patients reported significant sac shrinkage. Excluding from the analysis the first six patients as part of a learning curve, in-hospital mortality, major stroke and retrograde dissection rate significant decrease to 11%, 11% and 5.67%.
Operative techniques significantly evolve during study period, as confirmed by the higher use of custom-made limb for super-aortic stenting and the higher use of common carotid arteries
as the access vessels for this extension. In addition, fluoroscopy time, and contrast median's significantly decrease during study period. We learned that stroke and retrograde dissection are the main causes of operative mortality.
Of course, we can reduce stroke rate by patient selection excluding from this technique all those patient with the Shaggy Aorta Supra or diseased aortic vessel, and also by the introduction and more recent experience of some technical points like sequentIal clamping of common carotid arteries
or the gas flushing with the CO2. We can also prevent the retrograde dissection, again with patient selection, according to the availability of a healthy sealing zone, but in our series, 6 of the 24 patients
presented an ascending aorta larger than 40 millimeter. And on of this required 48-millimeter proximal size custom-made stent graft. This resulted in two retrograde dissection, but on the other hand, the availability on this platform of a so large proximal-sized,
customized stent graft able to seal often so large ascending aorta may decrease the incidence of type I endoleak up to zero, and this may make sense in order to give a chance of repair to patients that we otherwise rejected for clinical or morphological reasons.
So in conclusion, endovascular arch repair with double branch devices is a feasible approach that enrich the armamentarium for vascular research. And there are many aspects that may limit or preclude the widespread use of this technology
with subsequent difficulty in drawing strong conclusion. Operative mortality and major complication rates suffer the effect of a learning curve, while mid-term results of survival are more than promising. I thank you for your attention.
- Thanks Fieres. Thank you very much for attending this session and Frank for the invitation. These are my disclosures. We have recently presented the outcomes of the first 250 patients included in this prospective IDE at the AATS meeting in this hotel a few months ago.
In this study, there was no in-hospital mortality, there was one 30-day death. This was a death from a patient that had intracranial hemorrhage from the spinal drain placement that eventually was dismissed to palliative care
and died on postoperative day 22. You also note that there are three patients with paraplegia in this study, one of which actually had a epidural hematoma that was led to various significant and flacid paralysis. That prompted us to review the literature
and alter our outcomes with spinal drainage. This review, which includes over 4700 patients shows that the average rate of complications is 10%, some of those are relatively moderate or minor, but you can see a rate of intracranial hemorrhage of 1.5% and spinal hematoma of 1% in this large review,
which is essentially a retrospective review. We have then audited our IDE patients, 293 consecutive patients treated since 2013. We looked at all their spinal drains, so there were 240 placement of drains in 187 patients. You can see that some of these were first stage procedures
and then the majority of them were the index fenestrated branch procedure and some, a minority were Temporary Aneurysm Sac Perfusions. Our rate of complication was identical to the review, 10% and I want to point out some of the more important complications.
You can see here that intracranial hypotension occurred in 6% of the patients, that included three patients, or 2%, with intracranial hemorrhage and nine patients, or 5%, with severe headache that prolonged hospital stay and required blood patch for management.
There were also six patients with spinal hematomas for a overall rate of 3%, including the patient that I'll further discuss later. And one death, which was attributed to the spinal drain. When we looked at the intracranial hypotension in these 12 patients, you can see
the median duration of headache was four days, it required narcotics in seven patients, blood patch in five patients. All these patients had prolonged hospital stay, in one case, the prolongation of hospital stay was of 10 days.
Intracranial hemorrhage in three patients, including the patient that I already discussed. This patient had a severe intracranial hemorrhage which led to a deep coma. The patient was basically elected by the family to be managed with palliative care.
This patient end up expiring on postoperative day 21. There were other two patients with intracranial hemorrhage, one remote, I don't think that that was necessarily related to the spinal drain, nonetheless we had it on this review. These are some of the CT heads of the patients that had intracranial hemorrhage,
including the patient that passed away, which is outlined in the far left of your slide. Six patients had spinal hematoma, one of these patients was a patient, a young patient treated for chronic dissection. Patient evolved exceptionally well, moving the legs,
drain was removed on postoperative day two. As the patient is standed out of the bed, felt weakness in the legs, we then imaged the spine. You can see here, very severe spinal hematoma. Neurosurgery was consulted, decided to evacuate, the patient woke up with flacid paralysis
which has not recovered. There were two other patients with, another patient with paraplegia which was treated conservatively and improved to paraparesis and continues to improve and two other patients with paraparesis.
That prompted changes in our protocol. We eliminated spinal drains for Extent IVs, we eliminated for chronic dissection, in first stages, on any first stage, and most of the Extent IIIs, we also changed our protocol of drainage
from the routine drainage of a 10 centimeters of water for 15 minutes of the hours to a maximum of 20 mL to a drainage that's now guided by Near Infrared Spectroscopy, changes or symptoms. This is our protocol and I'll illustrate how we used this in one patient.
This is a patient that actually had this actual, exact anatomy. You can see the arch was very difficult, the celiac axis was patent and provided collateral flow an occluded SMA. The right renal artery was chronically occluded.
As we were doing this case the patient experienced severe changes in MEP despite the fact we had flow to the legs, we immediately stopped the procedure with still flow to the aneurysm sac. The patient develops pancreatitis, requires dialysis
and recovers after a few days in the ICU with no neurological change. Then I completed the repair doing a subcostal incision elongating the celiac axis and retrograde axis to this graft to complete the branch was very difficult to from the arm
and the patient recovered with no injury. So, in conclusion, spinal drainage is potentially dangerous even lethal and should be carefully weighted against the potential benefits. I think that our protocol now uses routine drainage for Extent I and IIs,
although I still think there is room for a prospective randomized trial even on this group and selective drainage for Extent IIIs and no drainage for Extent IVs. We use NIRS liberally to guide drainage and we use temporary sac perfusion
in those that have changes in neuromonitoring. Thank you very much.
- Good morning. I'd like to thank everybody who's in attendance for the 7 A.M. session. So let's talk about a case. 63 year old male, standard risk factors for aneurismal disease. November 2008, he had a 52 mm aneurism,
underwent Gore Excluder, endovascular pair. Follow up over the next five, relatively unremarkable. Sac regression 47 mm no leak. June 2017, he was lost for follow up, but came back to see us. Duplex imaging CTA was done to show the sac had increased
from 47 to 62 in a type 2 endoleak was present. In August of that year, he underwent right common iliac cuff placement for what appeared to be a type 1b endoleak. September, CT scan showed the sac was stable at 66 and no leak was present. In March, six months after that, scan once again
showed the sac was there but a little bit larger, and a type two endoleak was once again present. He underwent intervention. This side access on the left embolization of the internal iliac, and a left iliac limb extension. Shortly thereafter,
contacted his PCP at three weeks of weakness, fatigue, some lethargy. September, he had some gluteal inguinal pain, chills, weakness, and fatigue. And then October, came back to see us. Similar symptoms, white count of 12, and a CT scan
was done and here where you can appreciate is, clearly there's air within the sac and a large anterior cell with fluid collections, blood cultures are negative at that time. He shortly thereafter went a 2 stage procedure, Extra-anatomic bypass, explant of the EVAR,
there purulent fluid within the sac, not surprising. Gram positive rods, and the culture came out Cutibacterium Acnes. So what is it we know about this case? Well, EVAR clearly is preferred treatment for aneurism repair, indications for use h
however, mid-term reports still show a significant need for secondary interventions for leaks, migrations, and rupture. Giles looked at a Medicare beneficiaries and clearly noted, or at least evaluated the effect of re-interventions
and readmissions after EVAR and open and noted that survival was negatively impacted by readmissions and re-interventions, and I think this was one of those situations that we're dealing with today. EVAR infections and secondary interventions.
Fortunately infections relatively infrequent. Isolated case reports have been pooled into multi-institutional cohorts. We know about a third of these infections are related to aortoenteric fistula, Bacteremia and direct seeding are more often not the underlying source.
And what we can roughly appreciate is that at somewhere between 14 and 38% of these may be related to secondary catheter based interventions. There's some data out there, Matt Smeed's published 2016, 180 EVARs, multi-center study, the timing of the infection presumably or symptomatic onset
was 22 months and 14% or greater had secondary endointerventions with a relatively high mortality. Similarly, the study coming out of Italy, 26 cases, meantime of diagnosis of the infection is 20 months, and that 34.6% of these cases underwent secondary endovascular intervention.
Once again, a relatively high mortality at 38.4%. Study out of France, 11 institutions, 33 infective endographs, time of onset of symptoms 414 days, 30% of these individuals had undergone secondary interventions. In our own clinical experience of Pittsburgh,
we looked at our explants. There were 13 down for infection, and of those nine had multiple secondary interventions which was 69%, a little bit of an outlier compared to the other studies. Once again, a relatively high mortality at one year. There's now a plethora of information in the literature
stating that secondary interventions may be a source for Bacteremia in seeding of your endovascular graft. And I think beyond just a secondary interventions, we know there's a wide range of risk factors. Perioperative contamination, break down in your sterile technique,
working in the radiology suite as opposed to the operating room. Wound complications to the access site. Hematogenous seeding, whether it's from UTIs, catheter related, or secondary interventions are possible.
Graft erosion, and then impaired immunity as well. So what I can tell you today, I think there is an association without question from secondary interventions and aortic endograft infection. Certainly the case I presented appears to show causation but there's not enough evidence to fully correlate the two.
So in summary, endograft infections are rare fortunately. However, the incidence does appear to be subtly rising. Secondary interventions following EVAR appear to be a risk factor for graft infection. Graft infections are associated without question
a high morbidity and mortality. I think it's of the utmost importance to maintain sterile technique, administer prophylactic antibiotics for all secondary endovascular catheter based interventions. Thank you.
- These are my disclosures, as it pertains to this talk. FEVAR has become increasingly common treatment for juxtarenal aneurysm in the United States since it's commercial release in 2012. Controversy remains, however, with regard to stenting the SMA when it is treated with a single-wide, 10 mm scallop in the device.
You see here, things can look very similar. You see SMA treated with an unstented scallop on the left and one treated with the stented SMA on the right. It has been previously reported by Jason Lee that shuttering can happen with single-wide scallops of the SMA and in their experience
the SMA shuttering happens to different degree in patients, but is there in approximately 50% of the patients. But in his experience, the learning curve suggests that it decreases over time. At UNC, we use a selective criteria for stenting in the SMA. We will do a balloon test in the SMA,
as you see in the indication, and if the graft is not moved, then our SMA scallop is appropriate in line. If we have one scallop and one renal stent, its a high likelihood that SMA scallop will shift and change over time. So all those patients get stented.
If there is presence of pre-existing visceral stenosis we will stent the SMA through that scallop and in all of our plans, we generally place a 2 mm buffer, between the bottom edge of the scallop and the SMA. We looked over our results and 61 Zenith fenestrated devices performed over a short period of time.
We looked at the follow-up out up to 240 days and 40 patients in this group had at least one single wide scallop, which represented 2/3 of the group. Our most common configuration as in most practices is too small renal fenestrations and one SMA scallop.
Technically, devices were implanted in all patients. There were 27 patients that had scallops that were unstented. And 13 of the patients received stented scallops. Hospital mortality was one out of 40, from a ruptured hepatic artery aneurysm post-op.
No patients had aneurysm-related mortality to the intended treated aneurysm. If you look at this group, complications happen in one of the patients with stented SMA from a dissection which was treated with a bare metal stent extension at the time
of the initial procedure. And in the unstented patients, we had one patient with post-op nausea, elevated velocities, found to have shuttering of the graft and underwent subsequent stenting. The second patient had elevated velocities
and 20-pound weight loss at a year after his treatment, but was otherwise asymptomatic. There is no significant difference between these two groups with respect to complication risk. Dr. Veith in the group asked me to talk about stenting choice
In general, we use the atrium stent and a self-expanding stent for extension when needed and a fenestrated component. But, we have no data on how we treat the scallops. Most of those in our group are treated with atrium. We do not use VBX in our fenestrated cases
due to some concern about the seal around the supported fenestration. So Tips, we generally calculate the distance to the first branch of the SMA if we're going to stent it. We need to know the SMA diameter, generally its origin where its the largest.
We need to position the imaging intensifier orthogonal position. And we placed the stent 5-6 mm into the aortic lumen. And subsequently flare it to a 10-12 mm balloon. Many times if its a longer stent than 22, we will extend that SMA stent with a self-expanding stent.
So in conclusion, selective stenting of visceral vessels in single wide scallops is safe in fenestrated cases during this short and midterm follow-up if patients are carefully monitored. Stenting all single wide scallops is not without risk and further validation is needed
with multi-institution trial and longer follow-up
- Thank you very much Mr. Chairman, ladies and gentlemen. I'd like to thank the organizers for the opportunity to present once again, and I have no disclosures. So why do we repair popliteal artery aneurysms? You've already discussed this, it's to avoid complications,
and the real main aim is to prevent limb loss. One of the largest series was published by the SwedVasc Registry looking at over 700 patients having open repair. And wound-associated morbidity was about 10 and 20%, overall risk of limb loss at 11%,
and vein graft is significantly better than the prosthetics. We looked at Australasian data, and we looked at five-year prospectively collected data. We collected data on over 1,300 patients with almost 400 stent grafts and about 900 bypasses.
Prosthetic grafts accounted for about 10% of the prosthetic bypass grafts, and with 400 stents. These are the complication rates when the patients are subdivided for stents and bypasses. And as we can see, all major complications are much higher for bypasses.
We did a multivariate analysis by backward conditional modeling. And for any complication, bypass surgery, ischemic heart disease, and emergency surgery, as expected accounted for higher complication rates. We modeled this data for occlusion or amputation
and the only things that came out significantly were sub-optimal vein or prosthetic graft compared to good quality vein, and compared to stents and single-vessel runoff. Two other large studies that have been published,
and this large study by Professor Puli who just presented, showed no significant differences between open and endovascular repair in about 312 patients. Again, another paper here showed no differences in 186 patients. A meta-analysis data published with 500 patients
again showed no significant difference in the pooled primary data. And the Vascunet Collaboration of Registries also showed that the major amputation rate was only 2%, slightly higher after open surgeries as compared to endovascular.
But with the hybrid repair using prosthetic and other conduits. So, how do we achieve best results? Well, I think first of all we need to do an angiogram, in a neutral position. We do a flexed knee angiogram, which I think is essential
with a calibrated catheter. We find out the positions where we need to deploy the graft, and deploy the graft in a neutral position. And then very importantly, we do a completion angiogram both in the neutral and the flexed-knee position to ensure that we don't have any problems with this graft.
When you have problems here, this is when you have graft occlusion and this gives the procedure a bad name. But if you look at this angiogram in the neutral position, the picture on your left side shows a fabulous result in a neutral position,
but when you do the flexed-knee graft, there is a 60-70% kink at the distal end because of compliance issues, and this will not survive this graft. So which patients do we exclude? We exclude young patients with suitable vein,
patients with low-output heart failure and renal failure, and patients with a contraindication to an antiplatelet agent. This is quite essential, and Clopidogrel particularly is. So, this is a debate and I have got to say something really terrible about the next speaker.
So, I looked at... This is the last paper that they presented, and obviously, they said that the vein was best so I dunno why they were doing the procedure they were doing, really. But I call this procedure (laughs) "The French Fillet"
and as you can see, it involves division of the sartorius, the gracilis, the semitendinosus, and the medial head of the gastrocnemius to do this procedure. I mean, why would you do it? Muscles are important structures in the leg,
and a lot of the patients were aged between 22 and 89. They didn't give a median age, and all patients were very young, fit patients, and probably not able to run or walk again after that procedure with muscle cutting. So, it's a good French recipe
and these are the results of the procedure. In blue, you can see the vein graft, in white you can see the vein graft data, so they should stick to vein grafts or use endovascular repair. You know, get rid of modern technology, that type of
hybrid procedure is really, really old-fashioned. So, in summary, Mr. Chairman, ladies and gentlemen, endovascular popliteal artery aneurysm repair has now come of age, I believe. Popliteal aneurysm stenting can deliver results which are comparable to open surgery and vein grafts.
The technique must involve flexed knee completion angiogram, and medically unfit patients are probably not good candidates for endovascular repair, perhaps even open repair. Thank you very much.
- Thank you chairman, ladies and gentlemen, thanks for the organizing committee for the opportunity and the kind invitation. These are my disclosure regarding this topic. We know that several anatomic factors can be considered in order to identfy the challenging proximal aortic neck and and the risk of
Type one endoleak after EVAR. And we all agree that this is a condition that we would like to prevent after any of our standard EVAR repair. So we know that advance treatment we have illustrated and also with a chimney can be successful and prevent
such kind of complication, and today we do have another option that has already been presented it uses Heli-FX EndoAnchor in order to stabilize and fix the graft just at the level below the renal artery. This kind of approach can be used as a therapeutic approach
to solve proximal type one endoleak a different follow up interval after EVAR. But for sure the more interest is the application of this new technology of endosuturing is the prophylactic use to prevent any changes of the aortic proximal neck.
The advantages of using such kind of technique is mainly based on the possibility to maintain infrarenal sealing and to prevent any involvement of visceral vessels. Such not precluding any potential additional intervention like more complex like Ch-EVAR or f-EVAR.
What about the tips and tricks? As for any endovascular treatment any patient selection represents one of the most important aspect for each kind of treatment and we all know to respect that these kind of technology require a minimum length of the regular diameter
at the level of the renal artery. For sure the short neck is the one of the principle indication for the prophylactic use of EndoAnchors, you can see here that according to the instruction for use you can select patients with a neck less than 10 millimeter down to four millimeters.
Obviously angulated aortic neck but also wide neck which has been recently discussed as protective factor to prevent neck dilation during the follow up. Tapering of the proximal aortic neck is another good indication for the use of primary EndoAnchors with Heli-FX system, and you can see here that
also been reported to be an increased protective effect of EndoAnchors in patients treated with this approach in terms of sac regression. Obviously you have also to consider when not to use this solution because EndoAnchors does not create a new neck so you cannot include your patients with no neck
or a large amount of thrombus or calcium or large gap because as already discussed it prevents the penetration of the anchors into the aortic wall. Precise endo graph deployment at the level of the renal artery is of paramount importance if you approach short neck, if you lose
millimeters over there it doesn't really make sense to fix the graft into the unhealthy proximal aortic neck. And obviously when you think about the web deploy your EndoAnchor the more proximal part of the fabric of the extended graft is the ideal position in order to be sure to penetrate into the aortic neck.
And this another example you can see here the line very proximal in the first stent of the extended graft where you can deploy the EndoAnchors. If you lose any anchors during the repair is something that can happen after several number of EndoAnchors but you can manage,
you can recapture the EndoAnchors with the snare and remove without more complex distal complication and embolization. So finally if you approach a very challenging neck it is very important to increase the deployment procedure now you can do this kind of approach
with advance imaging software like in this case with the fusion. You cannot on the work station in the OR pre-plan where to deploy the EndoAnchors. You can see here for example a case with a six EndoAnchors so you can just fix on the pre-plan,
and then you fuse your image, you go live into the OR you have your target at the level of the renal artery and what you have to do is just center your target with your EndoAnchor delivery system. And obviously if you have also you can also scan and have an intraoperative control with then a CT
to be sure you're fixing the appropriate way with your case. So in conclusion, chairman, ladies and gentlemen. The endovascular fixation is effective in preventing proximal Type one endoleaks in selected patients with challenging neck anatomy. And obviously meticulous planning
and advanced intraoperative imaging are crucial for technical success. Thank you very much for your kind attention.
- 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.
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