- Again, I think I'm going to continue the theme here on talking about REBOA technologies and techniques, so thank you, Dr. Veith, again for allowing us this format. No disclosures on my part. Everyone by now has heard this term multiple times and I think this is a community that understands
Resuscitative Endovascular Balloon Occulsion of the Aorta. Not new technology, very familiar to everyone in this audience who frequently is called upon to deal with the ultimate model of noncompressible hemorrhage,
that of the rupturing abdominal aortic aneurysm. Dr. Veith showed us many years ago that we could get appreciable outcomes improvement with endovascular balloon occlusions here, and the military was certainly listening. Colonel Rasmussen developed this paper
describing the first techniques. The diagram on your left, one of our first civilian centers, in a classic military-civilian collaboration, that we rolled this out at at Shock Trauma, this is the algorithm that is utilized there and it has been exported to countless trauma centers
for incorporation into their own protocols. And, as it was also mentioned, the American Association for the Surgery of Trauma AORTA Registry is capturing these prospectively. We now have 34 centers and over 568 REBOAs captured as of November 2018.
And this hopefully will continue to provide us some of the data that we need to better differentiate optimal patient selection and optimal practices. So, again, another encouraging anyone in the audience to likewise contribute to those 34 centers. And we have evolving advances in technology, clearly,
some of that has been discussed about here already. And better understanding through the Endovascular Resuscitation Trauma Management Society, and other meetings like that, to look at procedural approaches that work and share knowledge across the full spectrum.
We have lower profile devices. We have the ability to monitor the patients to step up care in a stepwise fashion to optimize the survival of bleeding patients. The old Coda balloon we initially utilized for this approach for REBOA back when I started doing this in about 2008 was,
or 2009, was has largely been replaced by these military specific civilian and trauma specific technologies that Colonel Rasmussen mentioned briefly. The REBOA in 2018, the majority of centers coming on board from the trauma center perspective or utilizing the prime time ER REBOA catheter,
this is FDA approved for floroscopic, for use. It is 7 French compatible, has a distal arterial pressure monitoring port distal to the balloon, does not require a guide wire, and is exceedingly user-friendly for the majority of the people who are going to be putting these in,
which is the acute care trauma surgeon who's at bedside when these patients arrive. The techniques that we utilize and we teach in our American College of Surgeons Basic Endovascular Skills for Trauma course, our best course, which is our current standard for training of REBOA
to trauma and acute care providers and, increasingly a larger subset of providers, utilizes external landmarks. And this has been shown through both CT morphometric studies and clinical applications to be a very reliable modality in that patient who is actively
attempting to code in front of you. And Colonel Rasmussen also touched on our growing experience here. The Northern paper was really a banner presentation and an eye-opening report for we, as military providers, and the trauma community, with their 100 percent
survival to the next echelon of care. We've learned a lot from these groups and their ability to employ this device effectively in really a resource-limited environment where they don't have blood providers become a resource that is very limited.
It's a challenging environment and they were able to deploy this quite effectively. And, more recently, the Tactical Combat Casualty Care committee has released guidelines for utilizations technology across a wider spectrum of small, not just surgical teams,
but also resuscitative teams. These are some of the pictures of some of the crews that I deployed with recently. And we are small team living out of a backpack with very limited blood utilization. And having this capability in your backpack,
to get that patient to more of a hard stand definitive surgical facility is a game-changer for all of these types of providers put in these situations across huge geographic footprints including Africa and parts of the Middle East.
Refinement of techniques is also continuing to evolve. Tal Horer talked briefly about partial REBOLA, this is how I utilize this technology. In a more refined fashion, utilizing a manual compression of the balloon to titrate a blood pressure that keeps the heart and the brain happy
with normal tension and keeps the operative field until definitive surgical control's obtained in hypotensive resuscitation state. So we're not disrupting clot, we're not causing more bleeding and propagating the deadly triad with ongoing cuagulopathy.
It's a wonderful tool, wonderful approach, I think. This is how it works. To some degree you can see the surgeon, the REBOA catheter in place, that was placed before the abdomen was opened. The surgeon actively working to obtain definitive control.
And we have here the balloon, the pressure in the balloon, the monitoring port above the balloon. This is the pressure below the balloon, as measured off the side port of the 7 French sheath. So now I'm able to titrate a pressure that minimizes the risk of hypotension
for the brain, the heart, those critical organs, yet perfuses the distal organs to a safe degree so that we don't have that reperfusion payback after subsequent definitive surgical control's obtained. And this technology continues to grow across a wide spectrum of indications,
non-trauma hemorrhage indications. When you look at global health burden, post-partum hemorrhage is more likely, in 10 years, to benefit from the further integration of REBOA, than any trauma bleeding that we encounter. That's really just a huge global health burden
and there's an active community in both the U.S. and South America developing registries for implementation there and partnerships across multiple specialties. And there's now actually an NIH funded, clinical research project in development
to look at the use of these balloons in CPR, those patients in Vfib that are not refractory to electroshock, and to see if we can salvage some of those patients. So that is also in effect. Some conclusions, REBOA continues to evolve
for applications for trauma and has evolving opportunities, as well, in non-trauma areas and wider utilization is going to continue to be facilitated by continued device improvements, training and research. Thank you.
- That's a long title, thank you. We shortened the title, and just said, The Iliac Artery's Complicating Complex Juxtarenal and Thoracal Abdominal Repair. I have no disclosures. So, Iliac artery preservation is important whenever we start doing complex aortic aneurysm repair.
We don't understand completely what the incidence is with these extensive aneurysms. We know with AAAs, anywhere in the 10 to 40% have some sort of iliac artery involvement. It certainly can complicate the management as we get to these more complicated repairs.
Iliac artery preservation may be important for prevention of spinal cord ischemia, and those people in whom we can maintain both hypogastric arteries, it occurs at a less significant rate, with less severe symptoms and higher rates of recovery.
The aim of our study was to evaluate the incidence, management, and outcomes of iliac artery aneurysms associated with complex aortic aneurysms treated with fenestrated and branched endografts. Part of a PS-IDE study over a 15 year period of time,
this is dated from the Cleveland Clinic for the treatment of juxtarenal aneurysms and thoracal abdominal aortic aneurysms. For the purpose of this study, we defined an iliac artery aneurysm is 21 mm or greater as determined by diameter
by our core lab. We chose 21 mm because this was outside of the IFU for the iliac wounds that we had currently available to us at that time. We did multivariable analysis on the number of different outcomes. And we looked at the incidence
of iliac artery aneurysms by repair type. In all the aneurysms we treated, we see about a third of the patients had some level of iliac artery aneurysm involvement. In those patients that had less extensive thoracal abdominals, the type three
and type four abdominals, it occurred in about a third of the cases. A little bit less than the type two and the type one thoracal abdominals. We look at the demographics between those that had iliac artery aneurysm
involvement and those that did not have iliac artery involvement. It was more common in males to have iliac artery involvement than any other group. There are more females that didn't have iliac artery aneurysms. The rest
of the demographics were the same between the two groups. We look at the anatomic characteristics of the iliac artery aneurysms, about 60% of them were unilateral, about 40% of them were bilateral.
The mean iliac artery aneurysm size was 28 mm and that was the same on both sides. And we look at thought the percent that were actually very large, or considered large enough to potentially in and of themselves the repairs
greater than three centimeters. About 28% of them were greater than three centimeters on each side. If we look at our iliac artery aneurysm treatment type, this is 509 iliac artery aneurysms that
were treated out of all these patients. About 46% of them, we were able to obtain a seal distal to the iliac artery aneurysm. So it really only involved the proximal portion, the proximal half of the iliac artery.
20% of them, we placed a hypogastric branched endograft, and about 20% of them, we placed a hypogastric coverage plus embolization of that internal iliac artery. About 13% of them were left untreated at the time for a variety of different operative reasons.
Why is there a difference between the hypogastric coverage and embolization? It was availability of devices and surgeon choice at the time. At one point, we had a opportunity to be able to treat both fairly easily
on both sides and at one point we did not. Larger iliac artery aneurysms were treated with hypogastric coverage or hypogastric branched endografts, and there was a significant difference between the two. Most of the mean
size of those that were actually treated with either hypogastric branch or embolization for greater than three centimeters. If we look at peri-operative outcomes in those without iliac artery aneurysms versus those with iliac artery aneurysms.
We see that the fluoroscopy estimated blood loss is larger for those with iliac artery aneurysms, fluoroscopy time was longer and procedure duration was a bit longer as well. Obviously, a bit more complicated procedure,
more steps that's going to take a little bit longer to perform them. It did not effect the length of stay for these patients or the length of stay in the intensive care unit following the procedures. We look
at all-cause mortality at five years, no difference in whether they had an iliac artery aneurysm or not. It didn't matter whether it was unilateral or bilateral. If we look at aneurysm-related mortality, it's the same whether
they had the iliac artery aneurysm or not. Same for unilateral versus bilateral as well. Where we start to see some differences are the freedom from reintervention. This did vary between, among the three groups. In those patients without an iliac
artery aneurysm, they had the lower reintervention rate than those with the unilateral iliac artery aneurysm, and even lower rates from freedom from reintervention in those that had bilateral iliac artery aneurysms. Spinal cord ischemia, one of the
reasons we try to preserve both the hypogastric arteries. Look at our total spinal cord ischemia incidents. It didn't vary between the two groups, but if we look specifically, the type two thoracal abdominal aortic aneurysms in those patients that had bilateral
iliac arte higher rate of spinal cord ischemia compared to those that did not have any iliac artery aneurysms or those that had an internal iliac, a single iliac artery aneurysm.
So, iliac artery aneurysms affect about a third of the patients with complex aortic disease. They do not, their presence does not affect all-cause mortality or aneurysm related mortality. They are associated with a higher reintervention rate.
In extensive aneurysms, may be higher association with higher spinal cord ischemia rates. We need additional efforts are needed to improve outcomes and understanding appropriate application of different treatment options for patients with
complex aortic disease. Thank you.
- Thank you. 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.
- Morning, thank you very much, Mark and Frank, thank you. Here's my disclosures. So, access to the ascending aorta and aortic arch can be complex when people have had a lot of other procedures done previously. There's several different options, and what I'm going to present to you today
was a unique option that we had to undertake with a given patient when these other options weren't possible. So, upper extremity or neck access is an option from an axial subclavian standpoint, or even, potentially, from a carotid artery.
We have a fair bit of experience at our institution using axillary access. This shows a patient that needed a descending thoracic graft that had an occluded distal aorta that we went through a right axillary approach, and you can
place a large sheath. And as well for a lot of the off label approaches that we use for complex visceral anatomy we're able to do this through an axillary approach, and here you see four sheaths. This doesn't always get you what you need, though,
for the entire ascending or the arch in combination, it only lets you do a portion of that. Central access is feasible, as well. Sternotomy with and ascending conduit can also be done with a mini anterior thoracotomy with and ascending conduit. Here is a patient that had an arch debranching
through an open sternotomy approach with a sheath then placed in an antigrade fashion, in order to place devices down to the level of zone zero. This was an older case, and something that we don't do as often now, but was an option in this patient.
Another option is transapical. Here you see the way this is done, obviously from the Tavr experience, this has gained people's confidence in doing it this way, but you still have to cross the valve,
and in patients who have had a valve replacement, that is probably not something that you'd like to do with a large device. Here's an example of that. This was given to me by my friend Brad Leshnower, just so you can see, device coming through a
transapical approach, a pigtail catheter from a femoral approach, and able to get a device into the ascending aorta. So what if? This is a scenario that we faced. A patient that had good iliac access,
it wasn't trouble getting a device through tortuous or too small vessels, but had a prior ascending reconstruction that was really tortuous, redo surgery for a sternotomy, and had a valve replacement, as well. We actually originally tried the Body Floss technique,
which I'll show you, but I could not get the device to advance to where I needed it to be. Here's what the anatomy looked like. This is a chronic aortic dissection with aneurysmal degeneration. Here you see the prior ascending repair,
slightly more magnified view, with some of the difficulties you could see, to navigate this anatomy. This was the body floss with the wire through the right axillary. And here you can see what that looks like
with the pigtail catheter coming through, with the wire through and through, but we could not navigate the device all the way across and into the ascending where I needed it to be for a proximal landing. So what now?
Well, I'll have to give credit to one of my interventional cardiology colleagues. We're fortunate that at our institution we have a very collaborative environment, and I knew that some of his expertise with the transapical approach.
Here is just video from him, for a technique that they use for peri-valvular leak after someone's had a prior open valve repair, that's not a candidate for Tavr, that they go in through a transapical fashion
and use occluder devices to shut down that leak. This is the technique that's utilized with a combination of echo, ultrasound, and as well coronary angiography, but this shows you the windows that you're looking for, and the puncture spot that would be
possible to safely puncture in a percutaneous fashion the apex of the heart. This shows you what's done during that procedure. It's marked with a hemostat. Coronary angiography is done to identify the LAD, so you don't accidentally puncture the LAD.
That is poor form. And so with this case, what we did was get wire access through and through with a sheath that you can see going into the apex. Able to now advance this device all the way down. Get it to deploy accurately at the level of
left common carotid, which was the goal. And here you can see a pretty good demonstration, I have the arrows here. The red arrow shows you the sheath, that's exiting the chest, the right arrow is showing you a wire,
held with the hemostat that's outside the body, so that I'm able to get through and through access and navigate the device all the way to where it needs to be. Again, iliac was not an issue here, this was just the ascending and arch anatomy.
The closure is then done with an Amplatz occlusion plug, which again, this is a combination of expertise, because it's something that he's done a fair bit, and these are the different devices that are available to try to close that puncture site.
So this is what the end result looked like when we were able to get the device in place and able to navigate this challenging anatomy with a combination of specialties, with different expertise, being able to do this.
So I just present this as an interesting alternative when you've run out of sort of appropriate options to be able to get a device into a challenging environment, thank you.
- Thank you very much. So this is more or less a teaser. The outcome data will not be presented until next month. It's undergoing final analysis. So, the Vici Stent was the stent in the VIRTUS Trial. Self-expanding, Nitinol stent,
12, 14, and 16 in diameter, in three different lengths, and that's what was in the trial. It is a closed-cell stent, despite the fact that it's closed-cell, the flexibility is not as compromised. The deployment can be done from the distal end
or the proximal end for those who have any interest, if you're coming from the jugular or not in the direction of flow, or for whatever reason you want to deploy it from this end versus that end, those are possible in terms of the system. The trial design is not that different than the other three
now the differences, there are minor differences between the four trials that three completed, one soon to be complete, the definitions of the endpoints in terms of patency and major adverse events were very similar. The trial design as we talked about, the only thing
that is different in this study were the imaging requirements. Every patient got a venogram, an IVUS, and duplex at the insertion and it was required at the completion in one year also, the endpoint was venographic, and those who actually did get venograms,
they had the IVUS as well, so this is the only prospective study that will have that correlation of three different imagings before, after, and at follow-up. Classification, everybody's aware, PTS severity, everybody's aware, the endpoints, again as we talked about, are very similar to the others.
The primary patency in 12 months was define this freedom from occlusion by thrombosis or re-intervention. And the safety endpoints, again, very similar to everybody else. The baseline patient characteristics, this is the pivotal, as per design, there were 170 in the pivotal
and 30 in the feasibility study. The final outcome will be all mixed in, obviously. And this is the distribution of the patients. The important thing here is the severity of patients in this study. By design, all acute thrombotic patients, acute DVT patients
were excluded, so anybody who had history of DVT within three months were excluded in this patient. Therefore the patients were all either post-thrombotic, meaning true chronic rather than putting the acute patients in the post-thrombotic segment. And only 25% were Neville's.
That becomes important, so if you look at the four studies instead of an overview of the four, there were differences in those in terms on inclusion/exclusion criteria, although definitions were similar, and the main difference was the inclusion of the chronics, mostly chronics, in the VIRTUS study, the others allowed acute inclusion also.
Now in terms of definition of primary patency and comparison to the historical controls, there were minor differences in these trials in terms of what that historical control meant. However, the differences were only a few percentages. I just want to remind everyone to something we've always known
that the chronic post-thrombotics or chronic occlusions really do the worst, as opposed to Neville's and the acute thrombotics and this study, 25% were here, 75% were down here, these patients were not allowed. So when the results are known, and out, and analyzed it's important not to put them in terms of percentage
for the entire cohort, all trials need to report all of these three categories separately. So in conclusion venous anatomy and disease requires obviously dedicated stent. The VIRTUS feasibility included 30 with 170 patients in the pivotal cohort, the 12 months data will be available
in about a month, thank you.
- Thank you very much. I take over the presentation from Thomas Larzon, we, and different other people have the same approach to a ruptured triple A, trying to extend the advantages we have seen now, of an EVAR procedure in patients with inadequate anatomy, and to extend the limitation,
to patients with the less favorable anatomy. So, the concept of a ruptured EVAR has been already proven, with good research of three years, and I will build up, Thomas built up this presentation, on our so common experience that we published for fourteen years experience of two university centers,
performing EVAR on 100% of ruptured abdominal aortic aneurysms, over a 32 months period. So what we can see, is on the right side, this was the period where a part of the patient was treated by EVAR,
and the one that had not favorable anatomy were opened. On the left side, there is EVAR only, this a period 2009 to 11, you can see the effect of this change, is the operative cohort mortality moved from 26 to 24%, and total cohort mortality,
including to exclude the patient that are on feet, reduced from 33 to 27%. What changed also, is the protocol for anesthesia, so from a few patients that were treated under local anesthesia, actually, there are very few patients treated
just with general anesthesia primarily. What changed is the rejection rate, decreased from 10% to 4%, the age of the population treated increased, the part of women treated increased by 10%, and the amount of patients that are instable,
and treated, increased too. So, how to extend the limitation, the one is by using parallel grafts, or on table physician modified, extend graft to achieve what Benjamin does in his practice, a good seal proximal,
this is a three parallel graft, that worked very well. The other option, is to use Onyx for the distal landing zone, this is a technique that Thomas does use more liberally than we,
but is a good solution for patients where an IBD, for example, would not be possible, it doesn't require any special catheter, there is no contraindications due to tortuosity, and sealing is immediately obtained. Here, an example,
the aortoiliac, the main trunk, has been deployed here, then a (mumbles), the iliac extension is parked, can be deployed later, and as a Buddy catheter,
you can take a Bernstein catheter, you just position it in the origin of the hypogastric, or in the common iliac artery. Then, you deploy the distal extension, there is no more flow, slowly you'll stepwise,
5-10cc of Onyx can be applied, this allows to preserve the distal perfusion of the hypogastric, and to seal it. Sealing can also, with Onyx, can also be used in the proximal landing zone, there are two options,
here, the option with an instable patient that gets two parallel graphs with the remaining type 1 endoleak, you introduce your catheter through the leak, or the catheter inside the sack that is perfused, step wise, you will apply your Onyx.
Here, in another patient, of our experience, this is a suprarenal arteries after a triple A repair with EVAR that comes with the rupture, we combined here a chimney for the SMA, with a double brach device from Biotech,
deploy this, and you can see here there will be some leak. So, three days later, because the leak didn't have to do coagulation correct, once correct it didn't seal, we just very selectively, improvised with Onyx, the gap,
this is a three months outcome. Then, here a case of some Post EVAR with a type 1A endoleak, to extend this on the visceral aorta would have been very complex, this is why doctor Larson decided here just
to fill the whole sac with 60cc of Onyx, which worked very well. So, in Orebro, you can see that the 30-day mortality is 27%, the 90-day mortality is 30%, then the whole cohort,
including the 10% that have been excluded, has a mortality of 37 and 34%. From the different factor that was significant, you can see that local anesthesia works good, Aortic Balloon Occlusion works good, mortality in patients
with abdominal compartment syndrome is increased, mortality of patients in shock is increased, and finally, the mortality of patients having this adjunct procedure is not significantly increased, this holds true for the long-term outcomes.
So, we can see that by using adjuncts, every patient with a ruptured triple A can be offered an EVAR, eventually as a bridging procedure, chimney grafts can extend landing zones, Onyx can offer additional sealing options,
and valid long-term results for adjuncts has been proven. Thank you very much for your attention.
- Thank you Dr. Veith and Dr. Helan for the honor of the podium and for being included in this very prestigious panel. I appreciate it greatly. These are my disclosures. So there's a number of established strategies with fenestrated EVAR to overcome some of the challenges
that we face during these procedures. For downward oriented target arteries we employ brachial access, we deflect wires and catheters off of the top cap or a balloon that can be inflated. Fixed angle sheaths,
getting access into the target vessels can be accomplished by swallowing the balloon or replace a balloon into the target vessel first, inflate it and then deflate it while we're pushing forward on the sheath. And also the large bore femoral access
on the contralateral side allows us to have multiple access sites, multiple sheaths, but this oftentimes requires 20, 22 French sheaths to accomplish this. Well this standard FEVAR technique is what I adopted when I first went out into practice
and as often is the case, necessity becomes the mother of invention. And when we lost access to the beacon tip Van Schie catheters, we had to come up with alternative techniques for gaining access to these vessels
and for accomplishing these procedures. And what this strategy has eventually evolved in to is what I've coined as next generation FEVAR, and I take a slightly different approach from the well-established techniques. And these are the ancillaries that you need
to perform these procedures. The main thing is the conformable sheaths which has completely changed my approach to doing these procedures. And I'll show you a single case that illustrates many of the strengths of these conformable sheaths
and the strengths of this technique. But the conformable sheaths that are available in the United States are twofold. The Oscor Destino Twist, which is available in 6.5, seven French, and 8.5 French. There's also a 12 French sheath available as well
with variable deflection curves. The Aptus TourGuide is actually manufactured by Oscor and sold through an OEM to now Medtronic, but it is exactly the same type of the conformable sheath available in the same sizes and deflectable curves.
As far as our contralateral sheath, what I've found with this technique is that we've been able to significantly downsize the contralateral sheath to allow access by only using Rosen wires and leaving Rosen wires only behind in most of
the selected and wired vessels. This is a 16 French and now what I employ is a 14 French dry seal in almost all of our cases. So this is a patient with a juxtarenal aneurysm that had an accessory lower pole or duplicated left renal and a rather large IMA
that we incorporated through a PMAG design in the, in his repair. And this video shows the conformable sheath acting as not only the sheath but the selection catheter as it goes in to the fenestration and out into the target artery.
As we move to the next step, the glide wire then is passed into the vessel followed by a quick cross catheter, and then we exchange the glide wire for a Rosen, and then leave the Rosen behind and move on to the next vessel.
This is selection of the celiac and then selection of the right renal. And then the left renal. And actually we were able to get the second renal as well with this setup. This is one of the,
so this is delivering the stent to the celiac as we move back up and we kind of just reverse the order as we go back to one of the first vessels that we selected. And we would never attempt this maneuver with a fixed angled sheath. But the strength of the conformable sheath
allows it to maintain its shape and actually throw the stent across the fenestration and into the vessel rather than having the sheath into the target vessel and unsheathing it. We then can use the conformable sheath to select downward deflected branches as the IMAs illustrates.
And on the one month post-CTA all vessels are stented, widely patent, aneurysm sac has actually begun to shrink, and this is our 3D rendering of that one month CTA. So with my move I started keeping track of the amount of time it takes to catheterize these vessels. Real time from the start of catheterization to the end
of the final vessel being catheterized. And we did this in 57 consecutive cases with a total of 215 total fenestrations. I used brachial access not at all during any of these cases and we recorded this time. And what we found in those 57 cases
is that we had a mean of 30 minutes from the time we put the conformable sheath in to the time we were done selecting all of the vessels, that all the target vessels and had Rosen wires in those vessels. When we subtracted out the few outliers that we had
with high grade stenoses or extreme angulated origins, we ended up with a mean and a median that came together at about 21 minutes. The cost comparison has been raised as an issue, but when you actually only use one sheath it's actually cheaper to use the conformable approach
and it doesn't take into account the billed hybrid OR time which can be upwards of $200 per minute. The cost of brachial access and decreased target cannulation wire time. So in summary FEVAR with this approach and with conformable sheaths
facilitates selection of fenestrations, downward deflected branches and target arteries. It avoids the complications of brachial access and large bore contralateral sheaths. It provides additional stability to allow delivery of appropriately sized covered stents
and it simplifies the technique and decreases the costs. Thank you.
- Thank you Mark. Those are my disclosures. Those are the usual steps you have to do to perform a fenestrated endograft, go through the fenestration into the target vessel, then push a catheter to exchange a floppy wire for a stiff wire.
So this can be quite straightforward, or it can be a bit more difficult when you have this type of ongoing target vessel such as this right renal artery here. This is one of the first tips, is actually to use the top of the fabric because of this stage
the graft is still closed and you advance, you can see here a sheath as far as possible and then use the top of the fabric and get a glide catheter to advance over the wire. And this is an example of such a procedure, you can see the catheter advancing all the way
using the top to have support from above. Now, sometime when you're doing thoracoabdominal repair, the fenestration is far from the top of the endograft so that there's no way you can use it and curl the catheter. So then you can actually inflate a coated balloon just above the fenestration to have that specific support
from above, and this is what you can see here. Now this is kind of quite a changing celiac trunk that you can see here on the left. You can see the sheath is advanced here, and then the catheter is advanced from the top, now advancing the wire in a better position
and then advancing the catheter. Next step is to actually get a balloon over a Rosen wire, through the fenestration into the target vessel and then you inflate the balloon and while deflating it, you push the sheath over this balloon and finally, this is a selective
angio after stent implantation. This was quite a challenging celiac trunk that we managed from below. Most of our fenestrated procedures are performed now with three- and four- vessel fenestrations, so you need quite a significant number of sheaths
to go through the control of the limb. Sometime it's just possible to have four 7-French sheaths to go in through one iliac, so what we tend to do, is to have two sheaths in the two renals and two just balloons, and once we're done with positioning the renal stent, we switch and put position sheaths
through the vessel. But there's an easier way of performing this procedure, is to use preloaded catheter. Here you have wire and catheter going directly through the renal fenestration so you can access the renal fenestration from the same groin,
you get the device up and then only do the visual vessel from the other side. And this is an example here, I'm working from the delivery system, you see we're using long sheath and catheter. You can see here, getting access to the right renal artery
advancing a catheter over a wire. And then next, you will see that, we'll have injected a bit of contrast in the right renal to check that we haven't dissected or to check that we're in the main trunk. And then over a stiff wire, just advanced this
6-French Shuttle sheath over the catheter and the wire. This is a way of performing a quite difficult renal artery from below. Now a new option is to use a steerable sheath, we're using the Medtronic APTUS sheath at our center. This is another example of quite a difficult celiac trunk
and you see we managed to get access and then push a stent from below using this steerable sheath. This is the selective angio and the postop CT showing a patent celiac trunk. And we've been using those steerable sheaths in ruptured thoracoabdominal, using the T-Branch.
So for those patients, don't use an externally approach. We did at every aorta from the groin, and I did this small video in the plane, to show you this is one of the latest rupture we had, the patient had a prior frozen elephant trunk, so we first had to rely on the elephant trunk with a TEVAR
and then this is opening the T-Branch here. And now this is what I wanted to show you, this is a 16-French APTUS sheath, then I'm positioning first through the celiac trunk. And you can see we can really flip the sheath inside the branch and then advance
a wiring catheter to access the target vessel. Here first the celiac trunk, obviously I do all those cases under fusion guidance, you see here a wire advance in the celiac trunk. Now this the SMA, and you see I'm changing the angulation of the APTUS sheath to actually get access to it
and from below again, easy access to the SMA and then we just advance the bridging stent. This right renal was much more difficult because it was an emergency, so you see that this graft is not well adapted to this patient anatomy, the branch is very far.
So inside the 16-French APTUS, I had to push a 7-French sheath all the way down to the origin of the renal artery. And then we managed to advance this bridging stent here. So I'm going to move forward, this is another video
from Gustavo Oderich of the Mayo Clinics, saying that if you need to come from above, you can have preloaded catheters and push them directly there. This is to show you that if you come from above, you increase obviously the stroke risk.
Another benefit of coming from below is that you protect yourself from X-ray and I think this is very important. So we have new tools, you have a pre loaded delivery system, you're better protected, and you reduce a stroke risk. So I think it's safer to come from below, I like to actually do that in a safe manner,
rather than coming from above and not really controlling everything. Thank you for your attention.
- These are my disclosures. So 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)
- Good morning everybody. Here are my disclosures. So, upper extremity access is an important adjunct for some of the complex endovascular work that we do. It's necessary for chimney approaches, it's necessary for fenestrated at times. Intermittently for TEVAR, and for
what I like to call FEVARCh which is when you combine fenestrated repair with a chimney apporach for thoracoabdominals here in the U.S. Where we're more limited with the devices that we have available in our institutions for most of us. This shows you for a TEVAR with a patient
with an aortic occlusion through a right infracrevicular approach, we're able to place a conduit and then a 22-french dryseal sheath in order to place a TEVAR in a patient with a penetrating ulcer that had ruptured, and had an occluded aorta.
In addition, you can use this for complex techniques in the ascending aorta. Here you see a patient who had a prior heart transplant, developed a pseudoaneurysm in his suture line. We come in through a left axillary approach with our stiff wire.
We have a diagnostic catheter through the femoral. We're able to place a couple cuffs in an off-label fashion to treat this with a technically good result. For FEVARCh, as I mentioned, it's a good combination for a fenestrated repair.
Here you have a type IV thoraco fenestrated in place with a chimney in the left renal, we get additional seal zone up above the celiac this way. Here you see the vessels cannulated. And then with a nice type IV repaired in endovascular fashion, using a combination of techniques.
But the questions always arise. Which side? Which vessel? What's the stroke risk? How can we try to be as conscientious as possible to minimize those risks? Excuse me. So, anecdotally the right side has been less safe,
or concerned that it causes more troubles, but we feel like it's easier to work from the right side. Sorry. When you look at the image intensifier as it's coming in from the patient's left, we can all be together on the patient's right. We don't have to work underneath the image intensifier,
and felt like right was a better approach. So, can we minimize stroke risk for either side, but can we minimize stroke risk in general? So, what we typically do is tuck both arms, makes lateral imaging a lot easier to do rather than having an arm out.
Our anesthesiologist, although we try not to help them too much, but it actually makes it easier for them to have both arms available. When we look at which vessel is the best to use to try to do these techniques, we felt that the subclavian artery is a big challenge,
just the way it is above the clavicle, to be able to get multiple devices through there. We usually feel that the brachial artery's too small. Especially if you're going to place more than one sheath. So we like to call, at our institution, the Goldilocks phenomenon for those of you
who know that story, and the axillary artery is just right. And that's the one that we use. When we use only one or two sheaths we just do a direct puncture. Usually through a previously placed pledgeted stitch. It's a fairly easy exposure just through the pec major.
Split that muscle then divide the pec minor, and can get there relatively easily. This is what that looks like. You can see after a sheath's been removed, a pledgeted suture has been tied down and we get good hemostasis this way.
If we're going to use more than two sheaths, we prefer an axillary conduit, and here you see that approach. We use the self-sealing graft. Whenever I have more than two sheaths in, I always label the sheaths because
I can't remember what's in what vessel. So, you can see yes, I made there, I have another one labeled right renal, just so I can remember which sheath is in which vessel. We always navigate the arch first now. So we get all of our sheaths across the arch
before we selective catheterize the visceral vessels. We think this partly helps minimize that risk. Obviously, any arch manipulation is a concern, but if we can get everything done at once and then we can focus on the visceral segment. We feel like that's a better approach and seems
to be better for what we've done in our experience. So here's our results over the past five-ish years or so. Almost 400 aortic interventions total, with 72 of them requiring some sort of upper extremity access for different procedures. One for placement of zone zero device, which I showed you,
sac embolization, and two for imaging. We have these number of patients, and then all these chimney grafts that have been placed in different vessels. Here's the patients with different number of branches. Our access you can see here, with the majority
being done through right axillary approach. The technical success was high, mortality rate was reasonable in this group of patients. With the strokes being listed there. One rupture, which is treated with a covered stent. The strokes, two were ischemic,
one hemorrhagic, and one mixed. When you compare the group to our initial group, more women, longer hospital stay, more of the patients had prior aortic interventions, and the mortality rate was higher. So in conclusion, we think that
this is technically feasible to do. That right side is just as safe as left side, and that potentially the right side is better for type III arches. Thank you very much.
- Thanks again Dr. Greenhalgh, Dr. Veith. These are my disclosures. We first took on a systematic review and meta analysis on the risk of bowel ischemia after ruptured abdominal aortic aneurysm repair. We found the prevalence of 10%, and that's been very constant.
OR 11% open repair, twice as much as an EVAR. And it's incidence has been very constant over the years from 1995 to 2015 so this scatter plot shows we didn't learn anything on this subject in these years. So the diagnosis of colon ischemia
is difficult after ruptured aneurysm. And we sought to look how effective sigmoidoscopy is in the diagnosis. And towards that end, we did a retrospective cohort study from the AJAX-cohort I mentioned before. Patients who underwent ruptured aneurysm repair,
only those who had repair were looked at and three major referral hospitals. And those patients had to survive more than six hours after arrival in the ICU. We did sigmoidoscopy only on clinical suspicion. Sigmoidoscopy results were categorized as
no ischemia, inconclusive, mild ischemia, or severe ischemia grade two or three. Laparotomy was the reference standard to demonstrate no transmural ischemia. 345 patients were considered. 81 open repair, 19% EVAR.
80% were male. These were the ages. And the 30-day mortality in this entire group was 26%. So we looked at clinical suspicion for colon ischemia, and found 46 patients moderate, a big group no clinical suspicion,
and a small group of 16 patients with a high clinical suspicion. The no clinical suspicion group, no one turned out to have colon ischemia, and mortality in this group was 20%. When we look at the other end, the high clinical suspicion,
they had immediate laparotomy, so without colonoscopy, and transmural ischemia was found in 83% of these patients, and they had a mortality of 50%. But, of course, it's always the gray area, in the middle, that is interesting. And we came to this clinical suspicion when they had
bloody stools, septic profile, diarrhea, abdominal pain or distention, or unknown. And those patients with the moderate clinical suspicion, they received colonoscopy. Negative were 16 of them, mild colon ischemia were seen in 19,
and severe in 11 patients. They turned out to have transmural ischemia none of them in the negative. So the negative predictive value for sigmoidoscopy is really good. In the middle group with mild colon ischemia,
only two out of 19 turned out to have transmural ischemia. And the severe ischemia group, eight of 11 turned out to have transmural ischemia on operation. So there was a total of 10 patients in this group who turned out to have transmural ischemia.
So, in conclusion, Mr. Chairman, ladies and gentleman, sigmoidoscopy is highly effective in ruling out colon ischemia. So it can prevent unnecessary operations. And when in doubt, transmural ischemia detection increases with colonoscopy from 22 to 73%.
Thank you for your attention.
- I want to thank the organizers for putting together such an excellent symposium. This is quite unique in our field. So the number of dialysis patients in the US is on the order of 700 thousand as of 2015, which is the last USRDS that's available. The reality is that adrenal disease is increasing worldwide
and the need for access is increasing. Of course fistula first is an important portion of what we do for these patients. But the reality is 80 to 90% of these patients end up starting with a tunneled dialysis catheter. While placement of a tunneled dialysis catheter
is considered fairly routine, it's also clearly associated with a small chance of mechanical complications on the order of 1% at least with bleeding or hema pneumothorax. And when we've looked through the literature, we can notice that these issues
that have been looked at have been, the literature is somewhat old. It seemed to be at variance of what our clinical practice was. So we decided, let's go look back at our data. Inpatients who underwent placement
of a tunneled dialysis catheter between 1998 and 2017 reviewed all their catheters. These are all inpatients. We have a 2,220 Tesio catheter places, in 1,400 different patients. 93% of them placed on the right side
and all the catheters were placed with ultrasound guidance for the puncture. Now the puncture in general was performed with an 18 gauge needle. However, if we notice that the vein was somewhat collapsing with respiratory variation,
then we would use a routinely use a micropuncture set. All of the patients after the procedures had chest x-ray performed at the end of the procedure. Just to document that everything was okay. The patients had the classic risk factors that you'd expect. They're old, diabetes, hypertension,
coronary artery disease, et cetera. In this consecutive series, we had no case of post operative hemo or pneumothorax. We had two cut downs, however, for arterial bleeding from branches of the external carotid artery that we couldn't see very well,
and when we took out the dilator, patient started to bleed. We had three patients in the series that had to have a subsequent revision of the catheter due to mal positioning of the catheter. We suggest that using modern day techniques
with ultrasound guidance that you can minimize your incidents of mechanical complications for tunnel dialysis catheter placement. We also suggest that other centers need to confirm this data using ultrasound guidance as a routine portion of the cannulation
of the internal jugular veins. The KDOQI guidelines actually do suggest the routine use of duplex ultrasonography for placement of tunnel dialysis catheters, but this really hasn't been incorporated in much of the literature outside of KDOQI.
We would suggest that it may actually be something that may be worth putting into the surgical critical care literature also. Now having said that, not everything was all roses. We did have some cases where things didn't go
so straight forward. We want to drill down a little bit into this also. We had 35 patients when we put, after we cannulated the vein, we can see that it was patent. If it wasn't we'd go to the other side
or do something else. But in 35%, 35 patients, we can put the needle into the vein and get good flashback but the wire won't go down into the central circulation.
Those patients, we would routinely do a venogram, we would try to cross the lesion if we saw a lesion. If it was a chronically occluded vein, and we weren't able to cross it, we would just go to another site. Those venograms, however, gave us some information.
On occasion, the vein which is torturous for some reason or another, we did a venogram, it was torturous. We rolled across the vein and completed the procedure. In six of the patients, the veins were chronically occluded
and we had to go someplace else. In 20 patients, however, they had prior cannulation in the central vein at some time, remote. There was a severe stenosis of the intrathoracic veins. In 19 of those cases, we were able to cross the lesion in the central veins.
Do a balloon angioplasty with an 8 millimeter balloon and then place the catheter. One additional case, however, do the balloon angioplasty but we were still not able to place the catheter and we had to go to another site.
Seven of these lesions underwent balloon angioplasty of the innominate vein. 11 of them were in the proximal internal jugular vein, and two of them were in the superior vena cava. We had no subsequent severe swelling of the neck, arm, or face,
despite having a stenotic vein that we just put a catheter into, and no subsequent DVT on duplexes that were obtained after these procedures. Based on these data, we suggest that venous balloon angioplasty can be used in these patients
to maintain the site of an access, even with the stenotic vein that if your wire doesn't go down on the first pass, don't abandon the vein, shoot a little dye, see what the problem is,
and you may be able to use that vein still and maintain the other arm for AV access or fistular graft or whatever they need. Based upon these data, we feel that using ultrasound guidance should be a routine portion of these procedures,
and venoplasty should be performed when the wire is not passing for a central vein problem. Thank you.
- Seems that people are more interested in coffee than in cost of F evar and B evar. Anyway. I have no disclosures for this talk. Maybe you are not very well aware of cost effectiveness and why it is useful in society and when we started this study in France,
I did not know and I learned some basic things about cost effectiveness. Everybody knows that resources of the health care system are limited and there is a need to determine the most efficient procedure for a reasonable amount of money.
So let me explain to you what is the cost effectiveness calculation. When you have two treatment, you have to consider first cost and also efficacy. If, let's say, treatment A is inferior to treatment B, let's say the first option in the recent treatment
and then the efficacy of treatment A is superior to treatment B, then it is more efficient and less costly and it is obvious that new technique has to be adopted by the healthcare system. But then you have the technique in which the cost is higher than the former treatment
and the efficacy is lower. So there is no doubt that less efficient procedure, which is more costly has to be rejected. But then there are two options. The cost and the efficacy can be less efficient and less costly.
What should we do? And it can be more efficient but more costly. And then here there is discussion. Discussion between whom? Between people who pay, between people physician, between patient and so on.
That's why the cost efficiency is something which is more adapted to the evolution of the healthcare system and so on. When we started the Windows Trial some years ago, it was a prospective multicenter comparison. Non-randomized of Bevar versus open surgery
and looked for support by a public grant which paid for the, mainly for the cost of the graph and also the cost of the study. Open surgery was performed in all the, around the nation and was not supported by any grant and this study
was meant to obtain reimbursement. So it was a comparative study. The data were, came from the CRF in the Fevar and Bevar arm and the PMSI which is the national database and open surgery were only on the PMSI national database
which is mandatory to get if you want to be paid for what you've done as a surgeon. And we looked at the main diagnosis and the type of repair. Open with supra renal clamping or endo repair as mentioned before. The evaluation was clinic.
We looked at the commodities and complications for during the first hospitalization and further hospitalization and death. Economic data were provided by all the health care providers in France. So the group of patients, there were almost 2,000 patients
that were divided into three groups. One group one was pararenal arteries. In blue, you have the number of grafts and in yellow, the open surgical group. Type two, group two was a thoracoabdominal aortic aneurysm type three, type one, two and three
thoracoabdominal aortic aneurysms and these are the results. They have been published twice in the European Journal of Vascular Surgery. One was for one month outcome and the second one for the two years outcome.
Mortality here is shown. You see there's not a larger difference between the two groups. Let me remind you that the Fevar and Bevar were different for higher risk patient. Why open surgery was for patients vs open surgery.
Group two had abdominal. The mortality with Fevar was much higher and in group three, there was a benefit, clinical benefit for Fevar or Bevar. Here you have the cost. See, according to this group,
the cost is much higher, the larger, the longer than any of these, but the difference between Fevar and Open is high in the two first groups but almost, it is no longer significant in the third group. Cost effectiveness are boosted up and as shown here,
the group one is in green. You see it's more costly, but a little bit more effective because there's less death. In group three, less death, still higher cost, but in group two, more deaths and more costly. Here you have the longterm analysis.
It's similar to what we have heard this morning. Now rehospitalization, there were more rehospitalizations in Fevar and Bevar than open surgery and more cardiovascular events. Complications listed here. They were more frequent in the open group
and the total cost at two years is shown here. And there is a difference in 22,000 euros which is about the cost of the graft at least in France, and at two years, the cost effectiveness is shown here. You see that for type three, one, two, or three, direct abdominal analysis is more costly,
but more effective and for the pararenal analysis, it's so and so. So in summary, Fevar and Bevar were globally not cost effective, but thoracoabdominal aortic aneurysm were the only group close to cost effectiveness, but Windows trial has limits.
It is not a randomized trial. Open surgery included less risky patients and Fevar patients were unfit for open repair. What happened next in France? It's very amazing to see it was a favorable outcome. Fevar and Bevar were finally from Cook and Vascutek
are currently reimbursed in France, but only for a limited number of patients. That way the government tried to contain the cost of all these procedures. Well, thank you very much to all the people who worked on this.
- So, in terms of my presentations, I think Dr. Mills and I do have some agreement that we can treat some of these patients with intervention, initially at least, with some exceptions. So when we talk about treating patients with acute limb ischemia, advanced endovascular skills is a must.
You have to look at the appropriateness of the devices that we have in place. But also, I think the most important thing is that you have to achieve adequate arterial inflow to the foot by the time you've finished the procedure
with the improvement of pain, numbness, and any motor abnormality. Certain cases, obviously, you need open surgery such as emboli from atrial fibrillation to the femoral artery. But it is important to note that in terms
of acute limb ischemia, when you go from IIa to IIb, that's when you have to be aggressively try to open up as much as possible, again, with adequate flow to the foot. And again, with acute limb ischemia, its definition is less than 14 days.
It could be embolic versus thrombotic. And my focus is mostly on these targets on the thrombotic component because it has a high risk of limb loss. And again, the traditional open bypass surgery has been associated with increased risk
of morbidity and mortality as well as wound infection. When we talk about acute limb ischemia, you can, again, do surgery with thrombectomy, embolectomy, and again, open procedure, or you can do open surgery with intraoperative thrombolytics.
And again, what I go for is try to do, obviously, a diagnostic angiography followed by endovascular interventions using various technology that is in hands. And again, multiple publications has been shown that we can perform this procedure successfully
in patients with acute limb ischemia. And again, at least in the studies that I was involved with, we can see that 60% of these procedures can be completed in less than six hours and 80% was completed in 24 hours, maximizing the flow to the foot and limb salvage.
So this, again, in the PEARL registry, was shown to be both in acute and chronic cases. And again, significant improvement in terms of the treated vessels. So the goal of the treatment is removal of the clot, re-establish perfusion, minimize clot reformation,
but more importantly, identify the underlying lesion and the culprit and treat it. So again, treatment of the acute limb ischemia in percutaneous method by using thrombolysis and thrombectomy provides a minimally invasive alternative to restore perfusion to the symptomatic lower extremity
with minimal morbidity and mortality. And you can do it both for native vessels as well as in a bypass graft. In native vessels, you have a combination of a fresh thrombus superimposed on chronic atherosclerotic disease.
And by removing the thrombus, you can visualize the underlying occult lesion that's causing the occlusion. And again, by doing it endovascularly, you can identify the inflow, the occluded segment, and the outflow in a percutaneous fashion and open up the blood vessels.
And again, in my experience, you have also avoided fasciotomy and reperfusion injury because it's in a non-open technique. What are the benefits? Again, your benefits is that you convert the patients from an acute state
to a baseline chronic state. This is especially if you're doing something at two o'clock in the morning. Convert an urgent surgical intervention to an elective revascularization if necessary. You lyse the thrombi in the distal artery,
restoring patency to the outflow arteries which you cannot do surgically, or we have multiple incisions. Re-establish the patency of an occluded but non-diseased inflow source for possible subsequent bypass,
especially if the patient was presented to you late and has thrombosed off into the common femoral artery. Prevent arterial intimal injury from balloon catheter thrombectomy, avoiding operative thromboembolectomy, especially if you involve the tibial vessels,
then you have to go through each of those tibials and do open embolectomy. And then again, also you reduce the level of amputation in patients in whom complete success cannot be achieved. So, then end up either with a toe amputation
or a TMA, or they end up with a BKA or an AKA previously. The tool box involves, again, antiplatelet therapy. IIb, III inhibitors are extremely important, anticoagulants to make sure that the patient's anticoagulated.
You have your choice of tPA or rPA, infusion catheters, and various catheter devices to aspirate or remove the clot. Again, tool boxes: contralateral insertion, six Fr sheath, guard wires through the area of occlusion.
Again, in the case of the fresh thrombus, if you remove the thrombus, you can see the underlying culprit lesions which you can treat by endovascular interventions. In the native vessels, again, you want to be able to use a hydrophilic wire that goes easily
to the area of occlusion. And then after removing the clot, you can see the underlying lesion that can be treated successfully, therefore avoiding a major bypass surgery. And to finish up with a case,
58-year-old female comes in with rest pain and numbness for about two weeks. Again, multiple medical problems. ABI is 0.2. You can see in this case, the angulation is difficult, so it came to an antegrade puncture.
You can see the occlusion of the infrapopliteal segment, only a perineal one off. The wire goes very easily. Once you remove the thrombus, you can see that now the artery is open. However, there is a chunk of thrombus sitting in there.
And again, she has a single pair runoff to the leg, so in this case, we don't want to compromise that single runoff even though we removed most of the clot. So we use a filter wire and use an angiojet to remove the clot. You can see the underlying lesion here.
Is it a plaque rupture or a stenosis? Angioplasty was done. She goes home in the next day instead of having a fem perineal bypass graft. So in summary, again, majority of these patients can be treated effectively
with percutaneous techniques. Advanced techniques and experience is appropriate because of essential tools in hand to make sure that this is an outcome completed successfully. Thank you for your attention.
- Thank you, Captain, and I'd like to thank Doctor Veith for the opportunity today to further this discussion about vascular injury care, specifically endovascular options that have continued to emerge and become a bigger part of our practice. Vascular trauma remains a challenging entity
for anyone who takes care of trauma patients, on the battlefield it accounts for 12% of our trauma incidents and it's the second leading cause of death in both civilian and military trauma. And some of the most challenging
are those non-compressible sites which represent a majority of those that we really struggle with. There are a number of involving technologies and approaches that have been applied to trauma, we were going to talk in other talks about
REBOA and some of those options. But for the purpose of the talk here, I'm really going to talk about endovascular stent grafts as emergent and definitive tool managements. These make sense for a variety of reasons,
endovascular is becoming a bigger part of the trauma toolkit because we've had a significant shift in elective and emergency vascular work towards endovascular surgery. Every trauma center now, if they don't have one, is developing a hybrid OR environment
which is capable of providing high-end endovascular care. And we have an increase in familiarity both among surgeons, IR providers, and a variety of providers who take care of these trauma patients. Unfortunately, however, we as of yet do not have
any trials yet to prove the practice is better than open approaches. But we do have some success stories. A blunt thoracic aortic injury, if you have to pick one, is certainly a success story in trauma. Everyone in this audience is familiar
with the way that this has evolved. This is just one of a number of studies including the two AAST Center studies in 2008 and 2009 by the Aortic Trauma Foundation recently published in 2015 which showed that TEVAR was associated with lower transfusion requirements,
lower overall mortality, and lower aortic-correlated mortality compared to traditional open-repair modalities. And in the time that these technologies have been introduced, they have really changed practice. But what about other locations?
We have a variety of other anatomic locations that historically and traditionally have been challenging surgical exposures, the carotid at the base of the skull, the thoracic inlet, all these represent challenging options for open repair amongst trauma surgeons.
We do have some good evidence that needs to be expanded and further built upon that carotid capabilities from an endovascular stent graph repair perspective, particularly for those injuries at the base of the skull can be performed with a reasonable modicum of success. And with good followup to two weeks to two years,
patency rates are about 80% with low appreciable neurologic deficits after stent placement. Axillo-subclavian injuries represent another challenging open exposure for most trauma surgeons and an opportunity for vascular surgeons to introduce some more effective endovascular
stent graft technologies for application. Just one paper here from a myriad of trauma centers, a collaboration conducted by Doctor Branco, who showed that endovascular repair with injuries at these locations was associated with significantly lower mortality,
lower rates of surgical site infections, and a trend toward lower sepsis rates. And when you look overall at the invasion, if you will, of endovascular technologies this was a very nice review from a national trauma data bank of the American College of Surgeons,
which was conducted over nine years and over 40,000 vascular injuries. And you can see there, over time, we have seen a significant increase in use of endovascular procedures to deal with these injuries. I would say now that that is based upon data
from the PROOVIT Registry that is now roughly 20% of all vascular injuries have some endovascular technology applied. And these resulted in lowering hospital mortality following endovascular intervention and lower complication rate trends.
This is the most recent review, conducted by one of our visiting fellows when I was at David Grant, Major Robert Faulconer was a review of the AAST, or American Association for the Surgery of Trauma, perspective observational vascular injury treatment trial,
or called PROOVIT for short. And just very briefly, the punchline from this examination was that favorable outcomes were observed when arterial injury at non-compressible sites of truncal hemorrhage was managed with endovascular approaches.
The endovascular group, despite being more severely injured, had a lower mortality and a lower packed red blood cell requirement. And we're also learning that these technologies can be applied in hybrid techniques. This is just a simple example of a case
that was encountered at my own institution, this was a young man who had a gun shot wound through the right iliac artery and vein. He had an attempted interposition repair which blew out in the setting of small bowel contamination from associated bowel injury.
And we were really left with a very challenging situation in a patient who was physiologically depleted and would not tolerate a repeat definitive repair. And very little tissue to roll over the graft. So what we selected to do was what is known as a direct stent endo graft repair, or DSER.
And we basically bridged this gap with an endovascular stent graft utilizing the radial force to create a space for repair and not having a suture line now at risk in this contaminated field. This patient did quite well and
is now six months out with good results. This has been written about by several individuals and investigators to explain the use of stent grafts not only as a proxy or replacement for the typical plastic argyle shunt options, but these can actually potentially
become left in place when you come back for the repeat damage control surgery after initial repair. You can cover this with tissue graft and you now have a sutureless repair that is not prone to blow out as many of these injuries are in contaminated fields. Lots of unresolved issues with the investigation
and continued research in vascular traumas, particularly as it relates to endovascular graft repairs. Patient selection, we deal with young patients, small vessels, that natural history's not well established, anticoagulation and the definitive role of endovascular at a variety of locations is not well defined.
I mentioned the PROOVIT Registry, this has been going on for a number of years. It captures in-hospital outcomes and outpatient module questions. We do hope that this was able to answer some of the significant questions that we have in this area.
As of this month, we have over 4,000 patients in 27 centers, we still invite others to participate if anyone in the audience is interested. And we have a variety of issues we have already examined and will continue to examine in hopes that we can answer many of the questions
related to the optimal treatment of vascular injury. Thank you.
- The main results of the mid-term, I would call it rather than long-term, there were three years of the improved trial, were published almost immediately after the Veith Symposium last year. I have no disclosures other than to say this was a great team effort, and it wasn't just me,
it was all the many contributors to this project. I think the important thing to start with is to understand the design. This was a randomized trial of unselected patients with a clinical diagnosis of ruptured abdominal aortic aneurysm.
The trial was to investigate whether EVAR as a first option, or an endovascular strategy, would save lives compared with open repair. We randomized 613 patients quite quickly across 30 centers, and this comprised 67 percent of those who would have been eligible for this trial, so good external validity.
Survival was the primary outcome for this trial. This was assessed at 30 days, one, and three years. At 30 days as you can see there was no difference between the endovascular strategy group in blue, and the open repair group in red. However, already at 30 days we noticed
that of the discharges in the endovascular strategy group, 97 percent of these went home, versus only 77 percent in the open repair group. No significant difference in survival at one year, but now out at three years, the survival is 56 percent in the endovascular strategy
group versus 48 percent in the open repair group. This is not quite significant. If we look only at the 502 patients who actually had a repair of a rupture, the benefits of the endovascular strategy are much stronger. And a compliance analysis,
because there were some crossovers in this pragmatic trial, shows very similar results. And for the 133 women, these were the real beneficiaries of an endovascular strategy. The cumulative incidence of re-interventions to three years are shown here, and no difference between open
and endovascular strategy. And I'll dwell on these in more detail in a later presentation. But this did mean that there was no additional cost to the endovascular strategy over the three year period. I'd also like to point out to you that
apart from the re-interventions, the need for renal support in the early days was 50 percent more common after open repair. Patients had rather different concerns about their complications to clinicians. And when we discussed this with patients they were most
concerned about limb amputation and possibly unclosed stomas. All of these were relatively uncommon, but we had a great collaboration with the other two ruptured aneurysm trials in Europe, AJAX and ECAR. And we put our data together.
Took 12 months, and here you can see the very consistent results. That amputations are considerably less common after endovascular repair for rupture than open repair. We've just heard about quality of life. In Improve Trial there were real gains in quality of life.
Up to three years in the endovascular strategy group. And since costs were lower, this meant that this strategy was highly cost-effective. So in summary, at three years an endovascular strategy proves to be better than open repair. With better survival, higher qualities for the patients
in the endovascular strategy group, marginally lower costs, and it's cost-effective. And we've heard quite a lot even at this meeting about our new NICE guidelines in the UK. But an endovascular strategy is actually being recommended by them for the repair of ruptures.
And I think the most cogent reasons to recommend endovascular repair are the fact that it has benefits for patients at all time points. It gives them what they want: Getting home quickly, better quality of life, lower rates of amputation and open stoma,
and better midterm survival. Thank you very much.
- Okay, so I first continue. So after this data, which really, in our experience, really changed our treatment, we really don't want to treat, actually thoracoabdominals without coiling anymore. Now how to do it and, in fact, we also went through quite a learning curve. In the beginning, of course, was not easy for us
to reach segment arteries and big aneurysms all the tine. We learned form coiling in infrarenal aneurysms, I think, quite a lot and extended then to a higher segment of the aorta. So all together, it was not a short learning curve. So first of all, again, how do we do it?
We do it in local anesthesia, percutaneous, actually, always trans-femoral, although, sometimes the segmented arteries have a steep, at least in the beginning, a steep course downwards. We actually never come from brachial. We don't do a spinal drainage during coiling
and we monitor the patients 48 hours after that. We keep them in the hospital to see whether they develop any neurological complications, which they have, so far, never done. We don't do it on an intensive care and we also do not do spinal drainage then
during the stent graft implantation, which eventually, later then is done in general anesthesia. So this is the basic of the treatment, this is a little bit adopted from neuro radiology. Though, we are just taking bigger devices, so standard is so to say takes some six French
guiding catheter, usually I take an ema curve like this here. And into that very nicely fits a catheter, which is usually a source catheter, not this one, the source catheter is straight here. And through that source catheter, which is five French
catheter, we take a micro catheter through and that is here, this so called tower of power, which has been described, as I said, for neuro radiology procedures. So this is, however, sometimes the problem, you can of course choose several different curves here,
some are smaller, some are bigger. Bigger may not be so easy to handle and direct to your origin of the segmental artery, but in big aneurysms, of course, that can be a problem here to reach the arteries. So what we do with sticking a diagnostic catheter
into the guiding catheter is, that if you pull back here, now, your five French diagnostic catheter, you can really make out of this, move the twistable, toggleable catheter and that enables you in many cases to eventually then, really, in a stable way reach the ostium.
In those cases, where this is not possible, we use this steering deflecting steerable guiding catheters or sheaths, which is, of course, expensive and is really only necessary in very few selective cases, but this is clearly also helpful here. Side wind to one is loaded and then you can reach,
also, in very big arteries, aortas, the segmental ostium quite conveniently. So, of course, we don't do it in all cases, not in urgent repair, because after coiling or after every session of coiling, we want to have some time to let the spinal network develop.
So we can't do it in urgent cases. Renal insufficiency is a problem, although, with CT reading sometimes it's not so difficult to find the segmental artery origins, also, with very little contrast. Severe iliac kinking, aortic elongation
can be a problem indeed, we have some tricks for this and adipositas permagna, well, can be difficult, of course, difficult to see sometimes these arteries and that also requires then quite high radiation doses. This is what we do in very kinked iliac arteries and this is extremely helpful to have this some kind
of reinforced or extended power of tower. So in the beginning, we took a 12 French sheath in, we let the stiff wite in and we punctured, once again, up here of the sheath and brought parallel up then our usually power of tower and with this, you have a very, very stable condition
to reach the segmental arteries. Reason, that we changed to 12 French to nine French sheath, I don't think this is a problem in our days, having closure devices available for these kind of cases. So what shall we take for coiling, usually, we take this, let's call it regular coils
with these feathers, like, things here on top to induce thrombosis. Sometimes, in bigger segmental arteries, you can also do use a vascular plugs. This requires relatively stable access to the arteries. Clearly, no fluids, which are risky
and can embolize distally, we fear and may induce here even a spinal ischemia. So we have never used any fluids in these kind of cases. We are also still in the learning curve, for example, sometimes the arteries after coiling to open up again. Here is a case several weeks after coiling,
you can see here, that the blood here just passes these coils here, this is another case, where you can see, that actually the blood flow seems to be not diminished due to this coiling. So segmental arteries, we learned, are really completely different to others, you never see atherosclerosis here,
sometimes in the origin, probably some plug from the aorta, but they can develop very quickly to bigger arteries and that's why we probably see sometimes here a flow going down. So again, also, we have still a lot of things to work. Is it necessary to occlude them completely?
Is maybe reduction of flow sufficient? Sometimes maybe spinal ischemia is also due to embolization through segmental arteries and then this should actually be sufficient to avoid any embolization into the spinal cord. So after embolization, well, during embolization, also,
we also have to ask ourselves how densely do we have to pack these, cuz you can see, that there is several open areas between the coils. That should be actually usually enough to induce thrombosis. This is, we think, clearly, not enough and this is from the first publication,
not from our institute, I think this is definitely not enough, so indeed, you have to have some stable position of your catheter to pack these coils in and try to occlude the arteries as good as you can. So again, some questions to the coils, which should be used, the standard coils, maybe, which still have always
some holes in between. There are others, for example, the volume coils, which are used in neuro radiology. Which with one coil you can complete occlude the artery. Or there are some micro plugs, which actually go through micro catheters, those here are really
more sufficient and effective in closing the artery, but clearly they are also much more expensive, than regular coils. Where to coil, I think, it's very important not to coil too far distal, because then you're counter productive, you maybe avoid production or development
of this spinal network, you should really try to coil here at that proximal part here to let those networks here distally develop. This is, I think, very important and nevertheless, it can also occur, that you're actually coiling here at that proximal part or some collaterals develop
also proximal to these coils. So the more ostium your coil, I think, are better here. You can see, that we coiled here, but some coils collaterals developed here, feeding, now, here another segmental artery, which is secluded and the proximal part, but at the end we were not completely successful here
in occluding this segmental artery. So shall we also close every artery, shall we only close small arteries, sometimes we see, especially, in big aneurysms, that your ostium here is twisted and become stenotic, will become very difficult to get in. Same artery six weeks later, you can see here,
that it has developed already some collaterals, so do we need to coil this also? These are also still open questions. And then some thoughts about where to start. In the past, it was thought, that it was one big Adamkiewicz artery, great marginal artery,
but that is currently obsolete. We know, that there are several here. So shall we look for the biggest anterior radiculomedullary artery and shall we start with coiling here or shall we start somewhere else? Usually this ARMA, this big ARMA comes off
between TH 11, L one, L two, usually on the left side, here on the right side, so we found here, with our first shot here, this big ARMA going here into this spinal artery. So should we not close this now or should we exactly close this first, these are still open questions. First we go to this here, to have this closed
and let others develop here, some collaterals here. Here is another case, where a stent graft was already in this, not a covered stent, but an open cell stent and here we saw, that here are already some collaterals opened up. You can see here due to an injection to the right side,
this collateral worked upwards and then to the left side, finally here feeding the anterior spinal artery. So also in these cases, it demonstrates to you, that you should coil here, maybe, first, before you go to the other arteries. This is another example here, where to start,
how many and the first session, usually, we do four arteries. In the beginning, this is just our protocol, where we start now. We start usually in that area, we think the main radiculomedullary artery has its offspring
and from that we go more distal and into the proximal counterpart. So to summarize segmental artery coiling and these thoracoabdominal aneurysms can be challenging, it's a new field with may open questions. About our first experience with this is, for us,
really very promising and it's also safe. Thank you very much. (applauding) - [Man] Thank you for this great presentation. I have few questions to you, how long do you need for such an intervention?
And how can you be sure before you start with implantation, I suppose, that you will do this not in one session, but you will do this with a timeframe. That was a long year waiting and before you start to implant the prothesis, it is the question for you too, how you control, that all artery occlude?
- [Presenter] Yeah, many questions, so first of all, how long does it take to coil. So of course, in the beginning it took us some time. It always-- - [Man] Some hours. - [Presenter] Not some hours,
but you have published this also in your publication. - So the data, that we started with like two hours, maybe, it was two hours, but now we got under one hour. - [Presenter] Under one hour per session, let's say for segmental arteries.
It always depends, also, on the anatomy. In the beginning, we were waiting quite a lot between these coilings, because of course, that was all new for us, so we took the time, usually, these are cases, where you ordered a CMD, so you had a timeframe of two months or longer
to wait for the graft anyway. So this time we took for segmental artery coiling, we took several weeks in between segmental artery coiling, bu knowing from the animal models, that during one week, that spinal network should develop, actually, now, down to one week in between coiling sessions.
- [Man] Okay and how you control before you implant? - [Presenter] We don't. - [Man] You don't, you're hoping only? - [Presenter] Well, we have seen some segmental arteries open again, so we did, clearly, did not investigate this systematically, how many did open.
Again, because there are many questions. Maybe it's really enough to just have some coils and to prevent any embolization during the stent graft implantation towards spinal ischemia. We don't know all this, it seems to be a little bit problematic to really check it, we could check it by CT,
you could check it by angiography, but since you're using a lot of contrast during the stent graft implantation anyway there was a step, which we actually did not, now, do systematically. - [Man] And how many coils do you need to close all these arteries?
- [Presenter] For one segmental artery, you need something like four, five, six coils. So this, usually, coils, they recently got very cheap. - [Man] A very cheap intervention. - [Presenter] It is, it is, in fact, not too expensive. If you would use these volume coils, plugs,
that would be a completely other story on micro plugs, but these very standard coils is not expensive, indeed. - [Man] The last question, it is in regard of the application of this technique. Did you have any spinal lesions after stent implantation? - [Woman] So in this series, we have not had any issues
and we are currently looking at the matter, the non invasive imaging to exactly establish when is the point, the best point to implant the stent graft do we really need to wait as long or if we can implant it sooner. So we have some clues, that the preconditioning,
it's developing in one week and we are ready to go for the stent graft. It's very important, that you perioperatively, you adopt the classical perioperative on your strategies. That means we stop the blood pressure, lowering medication so we have a minatorial pressure of 85 to 90 millimeter
of mercury, we have a good oxygen saturation, that means you have a hemoglobin level around 10 gram per deciliter. And also on the ISU, the patient have the same tract. And we basically, we looked, that during the first month, the blood pressure of the patient, it's not too low.
- [Man] Do you have the impression this relationship between the type of aneurysm or the length of aneurysm, they're anatomical and the need of such an intervention? - [Woman] Well, basically, you've seen the data, the published data shows, that the inner thoracoabdominal krau-for type two after, endovascular period
you have up to 19% spinal cord ex-pand-ment of open repair, it's 22%. My opinions is, that the mechanism of spinal cord ischemia after about this procedure, it's different, but basically you need to treat both type of patient for the endovascular pair with both.
We think, that we should treat type two for sure and type three also and maybe type four, and we think type four too, because the proximal landing zone in those type of repair, it's not, it's not the same. So type four, basically, you treat it endo, you get your landing zone, as for treating type three,
and type three, it's getting in type two. - [Man] And did you observe any neurological side effect during the embolization? - [Woman] Recently, we had a patient, where we inject contrast and she had some numbness in her legs, but after two minutes or less than one minute,
she had nothing and we continue with the procedure and she recovered. But her blood pressure were, as I remember, it was not high, it was at systolic of 120 millimeter, that's why we stopped that coiling for that patient. And we had her blood pressure medication stopped
and recoiled them, her, after, I think, seven days. And we had no clinical evidence of spinal cord ischemia. - [Man] Thank you again for all this information, so that we implanted stents for years without this technique.
- [Presenter] Sorry? - [Man] Was that a criminal act? - [Presenter] No, I can only, from our experience, we did have quite some spinal cord ischemias after extensive stent grafting in long thoracoabdominal aneurysms.
It's always very terrible experience to have this. Since we do coiling, we didn't have any problem anymore. It's not a lot of patients, which I think, all together, we have maybe 80 now, but due to this experience, I don't want to do stent grafting without coiling anymore. - [Man] Okay, this is a very important message,
because this is a real religious message.
- Thank you very much for the privilege of participating in this iconic symposium. I have no disclosures pertinent to this presentation. The Atelier percutaneous endovascular repair for ruptured abdominal aortic aneurysms is a natural evolution of procedural technique due to the success of fully percutaneous endovascular
aortic aneurysm repair in elective cases. This past year, we had the opportunity to publish our data with regard to 30 day outcomes between percutaneous ruptured aneurysm repairs and surgical cutdown repairs utilizing the American College of Surgeons NSQIP database,
which is a targeted database which enrolls about 800 hospitals in the United States, looking at both the univariate and multivariate analyses comparing preoperative demographics, operative-specific variables and postoperative outcomes. There were 502 patients who underwent
ruptured abdominal aortic aneurysms that were included in this review, 129 that underwent percutaneous repair, whereas 373 underwent cutdown repair. As you can see, the majority were still being done by cutdown.
Over the four years, however, there was a gradual increase in the number of patients that were having percutaneous repair used as their primary modality of access, and in fact a more recent stasis has shown to increase up to 50%,
and there certainly was a learning curve during this period of time. Looking at the baseline characteristics of patients with ruptured aneurysms undergoing both modalities, there was not statistically significant difference
with regard to these baseline characteristics. Likewise, with size of the aneurysms, both were of equal sizes. There was no differences with regard to rupture having hypotension, proximal or distal extension of the aneurysms.
What is interesting, however, that the patients that underwent percutaneous repair tended to have regional anesthesia as their anesthesia of choice, rather than that of having a general. Also there was for some unexplained reason
a more significant conversion to open procedures in the percutaneous group as compared to the cutdown group. Looking at adjusted 30-day outcomes for ruptured endovascular aneurysm repairs, when looking at the 30-day mortality,
the operative time, wound complications, hospital length of stay, that was not statistically significant. However, over that four year period of time, there tended to be decreased hospital length of stay as well as decreased wound complications
over four years. So the summary of this study shows that there was an increased use of fully percutaneous access for endovascular repairs for ruptured aneurysms with noninferiority compared to traditional open femoral cutdown approaches.
There is a trending advantage over conventional surgical exposure with decreased access-related complications, as well as decreased hospital length of stay. Now, I'm going to go through some of the technical tips, and this is really going to be focused upon
the trainees in the room, and also perhaps those clinicians who do not do percutaneous access at this time. What's important, I find, is that the utility of duplex ultrasonography, and this is critical to delineate the common
femoral artery access anatomy. And what's important to find is the common femoral artery between the inguinal ligament and this bifurcation to the profunda femoral and superficial femoral arteries. So this is your target area. Once this target area is found,
especially in those patients presenting with ruptured aneurysm, local anesthesia is preferred over general anesthesia with permissive hypotension. This is a critical point that once you use ultrasound, that you'd want to orient your probe to be
90 degrees to the target area and measure the distance between the skin and the top of that artery. Now if you hold that needle at equidistance to that same distance between the skin and the artery and angle that needle at 45 degrees,
this will then allow you to have the proper trajectory to hit the target absolutely where you're imaging the vessel, and this becomes important so you're not off site. Once micropuncture technique is used, it's always a good idea just to use
a quick fluoroscopic imaging to show that your access is actually where you want it to be. If it's not, you can always re-stick the patient again. Once you have the access in place, what can then happen is do a quick angio to show in fact you have reached the target vessel.
This is the routine instructions for use by placing the percutaneous suture-mediated closure system at 45 degree angles from one another, 90 degrees from one another. Once the sheath is in place for ruptured aneurysm, the placement of a ballon occlusion
can be done utilizing a long, at least 12 French sheath so that they'll keep that balloon up in place. What's also good is to keep a neat operative field, and by doing so, you can keep all of these wires and sutures clean and out of the way and also color code the sutures so that you have
ease and ability to close them later. Finally, it's important to replace the dilator back in the sheath prior to having it removed. This is important just so that if there are problems with your percutaneous closure, you can always very quickly replace your sheath back in.
Again, we tend to color code the sutures so we can know which ones go with which. You can also place yet a third percutaneous access closure device if need be by keeping the guide wire in place. One other little trick that I actually learned
from Ben Starnes when visiting his facility is to utilize a Rumel mediated technique by placing a short piece of IV tubing cut length, running the suture through that, and using it like a Rumel, and that frees up your hand as you're closing up
the other side and final with closure. The contraindications to pREVAR. And I just want to conclude that there's increased use of fully percutaneous access for endovascular repair. There's trending advantages over conventional surgical exposure with decreased
access related complications, and improved outcomes can be attributed to increased user experience and comfort with percutaneous access, and this appears to be a viable first option. Thank you very much.
- I'd like to share with you our experience using tools to improve outcomes. These are my disclosures. So first of all we need to define the anatomy well using CTA and MRA and with using multiple reformats and 3D reconstructions. So then we can use 3D fusion with a DSA or with a flouro
or in this case as I showed in my presentation before you can use a DSA fused with a CT phase, they were required before. And also you can use the Integrated Registration like this, when you can use very helpful for the RF wire
because you can see where the RF wire starts and the snare ends. We can also use this for the arterial system. I can see a high grade stenosis in the Common iliac and you can use the 3D to define for your 3D roadmapping you can use on the table,
or you can use two methods to define the artery. Usually you can use the yellow outline to define the anatomy or the green to define the center. And then it's a simple case, 50 minutes, 50 minutes of ccs of contrast,
very simple, straightforward. Another everybody knows about the you know we can use a small amount of contrast to define the whole anatomy of one leg. However one thing that is relatively new is to use a 3D
in order to map, to show you the way out so you can do in this case here multiple segmental synosis, the drug-eluting-balloon angioplasty using the 3D roadmap as a reference. Also about this case using radial fre--
radial access to peripheral. Using a fusion of image you can see the outline of the artery. You can see where the high grade stenosis is with a minimum amount of contrast. You only use contrast when you are about
to do your angiogram or your angioplasty and after. And that but all everything else you use only the guide wires and cathers are advanced only used in image guidance without any contrast at all. We also been doing as I showed before the simultaneous injection.
So here I have two catheters, one coming from above, one coming from below to define this intravenous occlusion. Very helpful during through the and after the 3D it can be helpful. Like in this case when you can see this orange line is where
the RF wire is going to be advanced. As you can see the breathing, during the breathing cycle the pleura is on the way of the RF wire track. Pretty dangerous stuff. So this case what we did we asked the anesthesiologist
to have the patient in respiratory breath holding inspiration. We're able to hyperextend the lungs, cross with the RF wire without any complication. So very useful. And also you can use this outline yellow lines here
to define anatomy can help you to define where you need to put the stents. Make sure you're covering everything and having better outcomes at the end of the case without overexposure of radiation. And also at the end you can use the same volt of metric
reconstruction to check where you are, to placement of the stent and if you'd covered all the lesion that you had. The Cone beam CT can be used for also for the 3D model fusion. As you can see that you can use in it with fluoro as I
mentioned before you can do the three views in order to make sure that the vessels are aligned. And those are they follow when you rotate the table. And then you can have a pretty good outcome at the end of the day at of the case. In that case that potentially could be very catastrophic
close to the Supra aortic vessels. What about this case of a very dramatic, symptomatic varicose veins. We didn't know and didn't even know where to start in this case. We're trying to find our way through here trying to
understand what we needed to do. I thought we need to recanalize this with this. Did a 3D recan-- a spin and we saw ours totally off. This is the RFY totally interior and the snare as a target was posterior in the ASGUS.
Totally different, different plans. Eventually we found where we needed to be. We fused with the CAT scan, CT phase before, found the right spot and then were able to use
Integrated registration for the careful recanalization above the strip-- interiorly from the Supraaortic vessels. As you can see that's the beginning, that's the end. And also these was important to show us where we working.
We working a very small space between the sternal and the Supraaortic vessels using the RF wire. And this the only technology would allowed us to do this type of thing. Basically we created a percutaneous in the vascular stent bypass graft.
You can you see you use a curved RF wire to be able to go back to the snare. And that once we snare out is just conventional angioplasty recanalized with covered stents and pretty good outcome. On a year and a half follow-up remarkable improvement in this patient's symptoms.
Another patient with a large graft in the large swelling thigh, maybe graft on the right thigh with associated occlusion of the iliac veins and inclusion of the IVC and occlusion of the filter. So we did here is that we fused the maps of the arterial
phase and the venous phase and then we reconstruct in a 3D model. And doing that we're able to really understand the beginning of the problem and the end of the problem above the filter and the correlation with the arteries. So as you can see,
the these was very tortuous segments. We need to cross with the RF wire close to the iliac veins and then to the External iliac artery close to the Common iliac artery. But eventually we were able to help find a track. Very successfully,
very safe and then it's just convention technique. We reconstructed with covered stents. This is predisposed, pretty good outcome. As you can see this is the CT before, that's the CT after the swelling's totally gone
and the stents are widely open. So in conclusion these techniques can help a reduction of radiation exposure, volume of contrast media, lower complication, lower procedure time.
In other words can offer higher value in patient care. Thank you.
- Thank you. These are my disclosures. So, iliac artery can be your friend or your worst enemy, with cases of significant iliac artery occlusive disease. This doesn't mean you can't do it, but I always teach my fellows to give it the full meal deal.
I don't hesitate to dilate with the seven or eight millimeter angioplasty balloon, and then I'll follow that up with the dilators, and that gives me a good idea, if the dilator doesn't go up, it's time to consider some other route.
Rarely, I will do a conduit, and I usually will do this either with a purse-string in the distal common iliac artery, or a proper conduit with a synthetic graft, especially if I'm going to combine that with an ileofemoral bypass.
The thing to remember is you not only have to get the device up, you have to be able to turn it, and that's why I use those tips or tricks. Endovascular gear, we've already seen today a few speakers talk about some of the catheters and sheaths they like to have on the shelf.
I'll just take you through these. These are the specific ones I like to make sure I have. A stiff glide, and a Amplatz Super Stiff with a once centimeter tip, can again be your friend but also your enemy, so you have to treat those wires with respect.
And some people forget about that old trick of being able to put three 018 wires through a five French catheter, and that can sometimes get you deep into a superior mesenteric artery or a renal artery. Sheaths, I personally don't like
the angled sheaths from Cook. I find the Ansel One and Ansel Two sometimes work against you. I prefer to use the Raabe sheath, which is a straight sheath. The disadvantage of the Raabe sheath
is it comes with a very stiff dilator. So the tip here is just open the Ansel One, take out the High-Flex dilator from the Ansel One and put it up your Raabe sheath and that'll get you to where you want to be. The steerable sheath, Josh Adams did a great presentation.
It's an outstanding sheath. The only thing I would worn you is if you ride a tricycle through your whole life you won't be very good on a bicycle. So don't get too used to using a steerable sheath. Every once in awhile, just use it with the
old-fashioned catheters and wires before you, and open up the steerable sheath if you really need it. Beware short and downgoing renals. This is a trick sometimes you can use. Stephan Haulon showed this. You can drop, if you can't get any catheter
or sheath to follow, just drop a reverse catheter in, do the rest of the fenestrations, open up the top cap, and then put up a Coda balloon with your ipsilateral access, and you can use that Coda balloon to form a roof, and you can get any catheter or wire
to get into that tough renal artery. Beware of tortuosity, this really is your enemy. This, I have a low threshold just to go to a retroperitoneal exposure for either a direct puncture or conduit. There's nothing more demoralizing than deploying
a fenestrated graft, and if a lot of torque is built up into that because of those tortuous iliacs, you will see those fenestrations start to move as you deploy each stent, and that's sometimes an irretrievable situation. Renal artery occlusive disease used to be
a contraindication for fenestrated graft. It is no longer. Although, renal artery calcified and downgoing renals can really be a big problem, and always believe the CT, don't believe the angio. This is an angiogram of the same patient.
This does not depict what the real true story is. And with these particular cases, you know, most people in the room do not have access to customized fenestrated grafts, which sometimes you can use to help you with these cases. So this is a case that's interesting,
and what we did here is we basically came from above, pre-stented these with covered stents, and then that made the fenestrated graft on a second stage procedure, much easier. I didn't have to use any contrast. I could use these as my markers for the renals,
and in this particular case, I was able to use a steerable sheath for that short renal, and you can see how much that trajectory of that renal changed with that covered stent as well. Finally, this is a case that kind of highlights a lot of different tips and tricks.
This is a large aneurysm, juxtarenal with common iliac aneurysms, significant iliac and femoral artery disease. And so again, we kind of customized this. I'm not a big fan of snorkel and parallel grafts, but in this particular case I saw its use.
So I made a fenestration for the left renal and I planned to use a snorkel for the right because I couldn't get any kind of configuration to fit with the renal artery and SMA being on the same plane. So here I used that same balloon
for the iliac occlusive disease, to get the device up. You can see the issues here. There's the left renal coming off. I decided to fenestrate that and put a snorkel in the right renal, and this is what I did.
I was afraid that that fenestrated graft was going to cover the renal, so I came down from above just to mark the left renal. As I deployed the graft, I got out of the scallop, snared from the top, and then I brought a sheath down through the scallop, and I actually catheterized
the left renal from a downgoing perspective, and this worked quite well. I was able to snorkel right and then fenestrate the left, and we had an excellent result. And my final tip for you is don't go chasing endoleaks
with these long fenestrated procedures. If you have done the right procedure, all those endoleaks will seal. Thank you.
- [Professor Veith] Laura, Welcome. - Thank you Professor Veith, thank you to everybody and good morning. It's a great pleasure, to have the possibility to present the result of this randomized trial we performed near Rome in Italy.
Risk of CAS-related embolism was maximal during the first phases of the second procedure, the filter positioning predilation and deployment and post dilatation. But it continues over time with nithinol expansion so that we have an interaction between the stent struts
and the plaque that can last up to 28 or 30 days that is the so called plaque healing period. This is why over time different technique and devices have been developed in order to keep to a minimum the rate of perioperative neurological embolization.
This is why we have, nowadays, membrane-covered stent or mesh-covered stent. But a question we have to answer, in our days are, "are mesh covered stents able to capture every kind of embolism?" Even the off-table one.
This is why they have been designed. That is to say the embolism that occurs after the patient has left the operating room. This is why we started this randomized trial with the aim of comparing the rate of off-table subclinical neurological events
in two groups of patients submitted to CAS with CGuard or WALLSTENT and distal embolic protection device in all of them. We enrolled patient affected by asymptomatic carotid stenosis more than 70% and no previous brain ischemic lesion
detected at preoperative DW-MRI. The primary outcome was the rate of perioperative up to 72 hour post peri operatively in neurological ischemic events detected by DW-MRI in the two CAS group. And secondary outcome measure were the rise of (mumbles)
neuro biomarker as one on the better protein in NSE and the variation in post procedural mini mental state examination test in MoCA test score We enrolled 29 patients for each treatment group. The study protocol was composed by a preoperative DW-MRI and neuro psychometrics test assessment
and the assessment of blood levels of this two neuro biomarkers. Then, after the CAS procedure, we performed an immediate postoperative DW-MRI, we collect this sample up to 48 hours post operatively to assess the level of the neuro biomarkers
then assess 72 hour postoperatively we perform a new DW-MRI and a new assessment of neuro psychometric tests. 58 patient were randomized 29 per group. And we found one minor stroke in the CGuard group together with eight clinically silent lesion detected at 72 hours DW-MRI.
Seven patient presented in WALLSTENT group silent 72 DW-MRI lesion were no difference between the two groups but interestingly two patients presented immediately postoperatively DW-MRI lesions. Those lesion were no more detectable at 72 hours
this give doubts to what we are going to see with DW-MRI. When analyzing the side of the lesion, we found four ipsilateral lesion in the CGuard patient and four contra or bilateral lesion in this group while four ipsilateral were encountered in WALLSTENT patient and three contra or bilateral lesion
in the WALLSTENT group were no difference between the two groups. And as for the diameter of the lesion, there were incomparable in the two groups but more than five lesion were found in five CGuard patients, three WALLSTENT patient
with no significant difference within the two groups. A rise doubled of S1 of the better protein was observed at 48 hours in 24 patients, 12 of them presenting new DW-MRI lesions. And this was statistically significant when comparing the 48 level with the bars of one.
When comparing results between the two groups for the tests, we found for pre and post for MMSE and MoCA test no significant difference even if WALLSTENT patients presented better MoCA test post operatively and no significant difference for the postoperative score for both the neuro psychometric test between the two groups.
But when splitting patients not according to the treatment group but according to the presence of more or less than 5 lesion at DW-MRI, we found a significant difference in the postoperative score for both MMSE and MoCA test between both group pf patients.
To conclude, WALLSTENT and CGuard stent showed that not significant differences in micro embolism rate or micro emboli number at 72 postoperative hours DW-MRI, in our experience. 72 hour DW-MMRI lesion were associated to an increase in neuro biomarkers
and more than five lesion were significantly associated to a decrease in neuro psychometric postoperative score in both stent groups. But a not negligible number of bilateral or contralateral lesions were detected in both stent groups This is very important.
This is why, probably, (mumbles) are right when they show us what really happened into the arch when we perform a transfer more CAS and this is why, maybe,
the future can be to completely avoid the arch. I thank you for your attention.
- 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
- So, this is a prerecorded case. This is my disclosures. Well, we've all seen the concept of Percutaneous Venous Arterialization and this was discussed several sessions ago in the main hall of going crossing from an artery into vein and having multiple stent step would re-line the
venous wall and take away the valves and to bring blood to the capillary bit. Quickly, this is the animation of what goes on. An antegrade seven french sheath, a retrograde five french sheath. An ultrasonic system with alignment between the
artery and the vein and then a needle is driven, wired, pre-dilatation. The use of a 4 french valvulotome to cut the valves in the foot, to de-valvulotomize the valves and then after that, align the whole vein with a covered stent
to do an endovenous bypass. So, this is a prerecorded case courtesy of Dr. Daniel van Den Heuvel, an Interventional Radiologist out of Netherlands. So, this is a 70 year old lady with ulcer in the first and the fifth toe, Rutherford five.
Diabetic, hypertensive and failed conventional intervention. So, I'll start the video right now. Could we have volume please? Yeah, thank you. - Okay. (beeping) - Feel free to ask any questions.
I can pause the video. - [Doctor] So, we see proximal occlusions of the tibial vessels, and all collaterals going down to the foot. So, no direct target vessel for revascularization. So we apply the tourniquet with an Esmarch.
- So now, he's actually getting venous access at the-- - (mumbles) in the vessel. - Retro (mumbles) area. - Gently past the probe. Okay, so now the-- - I'll just pause over here. This is the device with the retrograde five french sheath
and the five french catheter, and the antegrade device that allows you to cross over an artery to the vein, and this is properly aligned in this case. - [Doctor] Marker of the arterial probe is at the same level as the venous probe. Let's fix it with a wet gauze, please.
And then, let's fix it and connect the arterial probe. So, I think this is the maximal-- - So, the ultrasound system allows a predictable crossing between an artery and the vein. - [Doctor] Feed and retract the venous probe. So, leave the sheath in while they are about
to retract the venous probe. Maybe, yeah. Also, pull down the sheath a little bit. - After alignment, the one probe is removed to give space for the crossing. - [Doctor] Yup, okay.
To puncture with a needle, you need to turn the device to unlock it and then advance it. Yeah. So, I unlock it. Okay. Yeah, this, see some contrast.
So, at the same time, we'll do the puncture with the needle. - That was quite subtle. You could see the needle push against the vein wall and it went right through the vein wall. - [Doctor] And then see what happens. - And, now, with an over the wire system,
you're able to introduce a wire. - [Doctor] It's in right away. - You know you're in the vein because of the appearance of the wire abutting a valve. - [Doctor] We can try to correct for that in the later stage.
- So, now, with a support of a CXI catheter, he's trying to catheterize the appropriate vein. - This is probably the right (mumbles) so. Okay, so this is the right one, so we crossed in the middle.
So, now, again, we go distal and lead gently. Try to, aha! Now, we're in the sheath. Okay, false.
Try for several times. If not, then-- So, okay, so probably now, already past the puncture point. Be gentle, just wait for the valve to open and not to push too much.
- So, the next step is to cross the valves and this maneuver is usually done with a variety of wires and the main thing that you need is actually patience. - Don't go too far (mumbles)-- - So, this could be supported with a balloon or a CXI catheter or any other catheter. - Yeah, okay.
Okay, and the wire is better. But, is it the right one? Yeah, okay. - The tourniquet is still on that you have gauzes or is it-- - Usually, at this point, after the crossing, you can actually take the tourniquet off, so--
- [Professor] The contrast is staying here in the-- - Yes, I think he probably injected some contrast through a superficial vein to maybe give a better visualization of the anatomy. So, I think, in this case, probably there was some either the tonic,
it wasn't off, or he injected some contrast. It can be useful. You know, it's not harmful to the patient. - [Doctor] Vein we're targeting, so. Now, we should be able to cross the-- - So, there are plenty of valves
in the foot. - The feet arch. - There's usually one in the mid area here. So, he was able to cross this. And then, after that, you're able to cross the venous arch with no problems because it's not diseased as like the arterial arch.
So, fairly predictable pattern of, very much similar the arterial system is in this case. - [Doctor] So, now, you open up the valvulotome. Close the two E again. Now, you can do like forward cutting with the valvulotome
It has, you see, and we know where there are valves here. You see the tapering of the valvulotome and now it's open. - So, when the valvulotome engages a valve, maybe I can double back a little bit. - [Doctor] Now it's open.
- A little bit more. - [Doctor] Forward cutting with the valvulotome. - So, when the valvulotome engages the valve, you can see a nearing of the valvulotome and then suddenly there's a jump and then the valve, the valvulotome opens up again.
- [Doctor] The valvulotome and now its open. - That's it. So, that's the typical appearance of how a valvulotome would cut the valve and we would rotate the valvulotome and cut it in multiple locations.
And then, the, this is implantation with a stent and we would generally avoid the bifurcation of the medial lateral plantar vein. So, this stent is a 5.5 millimeters at the bottom end. And, a tapered stent on the top. Maybe I'll just quickly--
- [Doctor] No more space, so I will just-- Dip finish. - Move up, so as he's continuing to stack up the stents-- - [Doctor] Preparing some, yeah. - And then, do an angiogram. You can see the area that you want to cross.
- [Doctor] So, now we can clearly see the ostium of the posterior tip. So, I want to stay distal of that. - So, this is done from a 3.5 to a 5.5 stent to make sure that we don't cover the origin of the perioral artery to prevent ex--
Occlusion of the collateral. - [Doctor] Do a longer inflation, so we have to five balloon again. - And post dilatation is done and-- - Okay. - In this case. - [Doctor] Yeah.
Four millimeter or a five. - This is done with a five. This looks like a five millimeter. Basically, to essentially rupture the vein, the vein is only serving as a conduit and after that, the stent is able to expand. So, this is a very nice picture
of good flow-- - It's nice. - No residual stenosis and good flow up the arch as well. And then, at the proximal end, I believe, he probably did some post dilatation as well. - [Doctor] Okay, here. - And sometimes, we do add on a (mumbles)
stent if the vessel is diseased on top, you know, but I think not in this case. In the proximal end, very good flow. Over here, the origin and-- So, this patient, pre-procedure, had gangrene over the tip of the toe and after that,
the gangrene had healed and on this site, not sure if this is gangrene or just a nail infection, but we know it got better and you can see that the foot is visibly different between before and after the procedure. It always look a little bit swollen,
but swelling has never become a major issue on a chronic phase. We haven't had patients come back with venous ulceration or anything along those lines. So, with that, I'd like to thank you. And this is a 3-D rotational angiogram
of, not a CT scan, rotation angiogram of what it looks like after the procedure. Thanks. - [Man] Fine. (applauding) - [Professor] Thank you, Steven,
for this great presentation, a really fascinating technology. I have a small question over-- - Yes, Professor. - What about digital arteries? Because in your picture, I never saw the digital arteries
after the bypass. - Yeah, Professor, that's a very good question and this is a problem that we continue to grapple with and we find it's seems to be unable to be solved because there are valves at the metatarsal and digital veins that go into the, to the toe.
And, one of the shortcomings of this procedure, it seems that we are unable to push the blood as distal as we want to push like a conventional angioplasty. So, I'm not sure if we're able to circumvent this for the future because, as you know,
the veins in the foot and the toes are really really very small and prone to spasm and very high restenosis. So, in the future, if we're able to bring the blood forward instead of a fly by across the foot, you know, like a conventional angiogram,
this may hold a future for what we're doing. But, until now, we don't really have something like that. What we can do and what Roberto has done is to focalize and to selectively pressurize the flow forward with a selective embolization of large collaterals like the great saphenous vein
or even surgical ligation. But, this is, you have to do it very gently 'cause if you, if you take away these outflows, then there's a risk of thrombosis, but if you have too many outflows, then the blood does not reach the foot in front,
you know, so this could be a potential for studies in future. Maybe pressure monitoring or something along that line. Yeah. - And what about the patency? - The patency?
Well, the patency is not very good in this procedure, as I must confess, you know. We do have re-intervention for this procedures, but a re-intervention is actually quite simple if you are able to survey it, mostly like a bypasses in the distal end.
So, one wire, one drug coated balloon would usually solve the problem if you detect it before thrombosis. If you do have thrombosis, then it's going to be a problem because it's like a bypass. You have to use a Rotarex disc, that's been my experience,
to clean up the whole graph. Quite quick and then do a bit of thrombolysis to clear the clot that's in the veins and certainly the secondary patency is not so good if the, if the veins all thrombose because with thrombosis,
the veins have a intense scarring and inflammatory process, so I find that the benefit of re-intervention early is much better in terms of the clinical as well as the angiographic outcome and the perfusion as well.
So, surveillance like how you would survey for a distal bypass and treat the stenosis early. - It's Lisa. (mumbles) - Okay, thank you very much for this very nice presentation.
- [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.
- [Stephan Haulon] I'm going to present a case that was quite a challenging case. Those are my usual disclosures. And this patient I'm quoting is a patient that had dissecting thoracoabdominal aneurysm that was more than 18 centimeter long. You can see that there's major issues with the kinks
in the mid-descending thoracic aorta, two over 90 degree kinks, and you can also see that we're working in the narrow true lumen here, and what I want to show you here is that the SMA looks kind of occluded or with a mild perfusion, and you can see that above the celiac trunk,
it is nicely perfused, whereas you can see here that the true lumen is completely collapsed at the level of the visceral vessels. So there was a couple of issues associated with this case. This is a lateral mid-view showing you that the true lumen is completely collapsed here.
I'm not exactly sure what's happening with the SMA here. Sorry, and this is the IMA, lower, and you can see that there's a very large IMA that was patent and perfused by the true lumen. So we decided to treat this patient with a free thoracic endograft done proximal, then a TEVA,
and then the distal tubular graft that was landed just above the origin of this IMA. I designed the graft with a branch for the SMA not knowing exactly what I would look for, and the previous surgeon that referred the case to me
didn't manage to get a thoracic device up in this patient so there was a real concern that we would struggle during the case. The patient is contraindicated in the age, not far from his 80s, and had severe COPD, that's why he was not a candidate for an open approach.
So we used this four branch device, and what is specific about this device is that it has a TPDS delivery system, so what is that? This is something that I learned from Piotr Karpzak's research, it's a system where you have four pre-loaded wires that are already through the branches
so they're outside the graft, through the branch, inside the internal lumen, and you will see on the next video, this is the delivery system, and you can see that the pre-loaded wires are actually in a sheath above the delviery system. So you work over a through and through wire,
and this is Piotr's hand that you can see, you have a four meter through and through wire coming from the left axillary to the groin. Over this through and through wire, you advance a catheter from the top, and on the other side you will get the delivery system of the endograft,
you will see that very soon. You can see here is the sheath that is on top of the delivery system of the endograft, where you have the pre-loaded wires. So you're going to get the whole system up and get this proximal sheath from the axillary approach,
and then you have those wires that will direct you directly to the branches. So this is the case, you can see we have through and through access, and as I told you, the beginning of the case was trying to get access to the SMA to understand if the SMA was perfused by the true
lumen, or the false lumen. So here I'm looking from the false lumen, now I'm in the true lumen, trying from above, from below, and actually I never find access to the origin of the SMA, so I did this selective angio 3D image, and you
can see that the SMA is actually perfused from the IMA, so I was wrong to design a branch for the SMA, and I decided to occlude the branch. So to handle those huge kinks, I used the push and pull technique, you know, and you can see how I'm getting this graft up over all those kinks,
this is the first thoracic endograft. You will see on the next picture that once the graft is in position, I push on both ends of the wire so that it loops in the ascending. I position it just distal here to the left subclavian artery, and we're going to release this
first thoracic endograft, then get the second component up, and you can see it's still quite a challenge. And then we get it up, we need to have at least three or four stents overlap to release it, and remember this major kink that we had in the
mid-descending thoracic aorta. You will see that there's going to be sort of eructation. The patient, his blood pressure raised very significantly once I released the second graft so I had to use this scleroballoon right away to reopen the endograft lumen.
This is the third thoracic endograft that is positioned just above the celiac trunk, and now we're advancing the delivery system. You can see this is the sheath at the top of the delivery system where you have the pre-loaded wires, it goes inside the sheath, and I'm
getting the T-branch or the full branch endograft up here and we will position it like the other ones using this through and through technique, pushing from below and pulling from above. This is an angio to check that my fusion markers
are in a good position, and then we're going to open the endograft, making sure that the celiac trunk is above the celiac trunk marker, SMA above, and those are the two renal fenestrations above the origin of the two renal arteries. And then, using this pre-loaded wire, I push the catheter
directly through the fenestration from the top, getting access to the left renal artery. Once I have positioned a rosin wire into this left renal artery, I advance a Covera stent here, in this case I use Covera stents for the renals and BeGraft Plus for the visceral.
What you can see here is I'm actually releasing this Covera stent with quite a significant amount of the stent within the renal artery to have a very stable platform. At the top, you need to make sure that you have a full overlap with the branch.
I'm obviously not going to show you the four branches, I'm going to skip directly to the completion angiogram, and you can see the completion angiogram with the celiac trunk, both renals, and then the IMA feeding retrogradely the IMA, the SMA. So I was quite happy with this result.
Oops, now I need to go to the next slide please. There you are, thank you. So this was the post-op CT, and everything looked good at a first glance, but when looking more carefully on this CT scan, what I found is actually I had a very
large type 2 endoleak from this SMA that I never managed to access from the aortic lumen. And you can see the SMA is filled retrogradely and then is feeding the aneurysm sac, so now I have a big type 2 endoleak, which I think we'll never seal spontaneously because it's perfused by the SMA.
So I had to take this patient a couple of weeks later back to the OR under local anesthesia again using fusion guidance, and you can see here that I'm getting access to the IMA, injecting contrast to check that I'm in the right position, and then I'm
going to push a micro-catheter inside. You can see the microcatheter going up here, I'm going to inject again to check that I'm going the right direction. So this is the tip of the micro-catheter here, I have a lot of markers showing me the way to go,
the micro-catheter is now advancing, and I'm now almost where I need to be, and I'm going to check on the lateral view now. You can see, this is where is the tip of the micro-catheter, and I'm checking with the diffusion that I'm actually now at the origin of the SMA, this is an outline
of my fusion mask, and this is with the 3DVR. You see that I'm really where I need to be, and now I'm just advancing a couple of micro-coils at the origin of the SMA and just looking. This is the first branch of the SMA so I know that I'm not blocking anything special here.
A couple of coils, and then I'm going to check what's going on with my micro-catheter. And you can see that there's still flow going through those coils, so I added a couple of coils, smaller coils to get a nicely packed embolization. You can see a couple of coils that are advanced again.
And then this is the completion angio. You can see we're actually feeding the SMA, but not anymore the aneurysm sac. Can we move to the next one please? Thank you very much. So this is now the CT scan after this embolization.
You see the coils are just at the origin of the SMA. I don't have any more endoleak inside, those are artifacts from the coils, and we finally have completely excluded this complex thoracoabdominal aneurysm. So I think that the trick here was to use those
pre-loaded delivery, sorry, branches to the visceral and renal arteries, to use a through and through wire to get the device up, to use fusion imaging to know if we were in the true/false lumen, to know where the origin of the target vessel was, and as usual for
those complex dissection, you have to expect staged procedures to completely exclude the false lumen from aortic flow. Thank you very much for your attention. - [Speaker 1] Thanks Stephan, for a wonderful case. Any questions or comments, maybe just while you're
thinking about it? So I just missed a little bit in terms of the pre-loaded SMA wire, you can obviously use that to get through, and I presume you used an Amplatzer plug, or how did you embolize? - [Stephan Haulon] So, how did I block the SMA branch?
So usually the way I do it, I put a balloon expandable covered stent that is quite long, 47 or 57, and then I put an Amplatzer inside. - [Speaker 1] So that's a good tip, yeah. Obviously the trunk itself is too short to be confident with that.
- [Stephan Haulon] Yeah, at the beginning of the experience, I was just putting an Amplatzer in the trunk, and we had a couple of failures, and now I feel more secure positioning a nice landing zone. I mean, having a longer branch with this being expandable. - [Speaker 1] So that's a very good tip, thanks for that.
- [Speaker 2] I have a question, I mean, we know how important is the SMA, especially in these patients, but if you have to do another case like this one, do you think this could be more useful to do a first stage total to reopen the SMA to the celiac or to the IMA?
- [Stephen Haulon] The problem here was that the true lumen was completely collapsed, and I didn't know if it was just a dynamic malperfusion, or if there was some kind of stenosis. I still don't understand exactly. The idea when I started the case was that if I could
actually access the SMA, was to do exactly what you're saying, I was going to probably stent it to reopen it at the beginning. But I never managed to access the SMA from the true, the false lumen, from above, from below. Probably this was
because, maybe because the IMA was perfusing with a very nice flow this SMA. So I think there was some kind of retraction of the origin of the SMA. - [Speaker 2] Okay. - [Speaker 1] Stephan that thoracic component that's
got a tortuosity of 270 degrees, or worse, you know, in your experience you did a great job delivering the graft, but how's that going to perform, do you think, in terms of, you know, when we see remodeling, and do you think there's a risk of significant kinking and stenosis of the lumen?
- [Stephan Haulon] So I mean, the second graft when it went through that specific curve, occluded the true lumen right away. The blood pressure went up like an acute coarctation, and I think that with my coated balloon I actually burst the dissection flap, and that's why it's now
open, and I checked on the CPR that I have a nice lumen. But it's a concern, I think very importantly when you have such angulation, you need to be very aggressive with the overlap between the various components because you don't know what's going to happen, and you see we have I think almost four or five stents overlap between the
various components. - [Speaker 1] Okay, well thank you very much.
- Thank you, Doctor Chuter. So, as you saw in Eric's presentation, really indwelling catheters and wires have become more or less routine for us. And they're nothing new to this era of complex and vascular repair. We've seen them a long time and
we started using them, of course, for iliac branch devices, as you can see here. And the concept is the same when you use them for other branches or fenestrations, as I'll show you. And here, an iliac branch is coming over with that indwelling catheter and snaring
from the contralateral end to be able to get that sheath. This is a helical-helical device, so putting that sheath over to get access to the contralateral side. So why and when do we need preloaded grafts with wires or catheters for complex aortic repair? Well, sometimes we have access issues
and it alleviates that, as I'll show you. Having the fenestrations or branches pre-catheterized will intuitively reduce X-ray exposure times and operating times, and also help catheterization in difficult anatomy, as Eric alluded to, and thereby
keeping the procedure down and avoiding large sheaths in both groins, at the same time minimizing lower-extremity ischemia time. This is an example of putting a fenestrated device in a previous infrarenal device. And the multitude of markers here
makes it very difficult to actually locate the fenestrations on the new graft, so it's very advantageous in these settings to have the fenestrations preloaded. This was first described by Krassi Ivancev back in 2010, and this is the original
preloaded design for a juxtarenal fenestrated device. And you can see a loop wire going through the top of that device. And a very simple handle with a couple of wires and things coming out of it, and some technical difficulties with wire catches
and other things made us move away from that design. It was later evolved into this bi-port delivery system, which allows you to have access to two fenestrations from a unilateral approach with indwelling renal wires and then sheaths, and having
those wires go through the renal fenestrations. And this evolved into the p-branch off-the-shelf fenestrated device from Cook, as you can see here. And you can see that loop wire coming out through that right renal fenestration
going through the top of the graft. And this is the catheter just describing how you then can use a double-puncture technique to access that renal artery and place the sheath there. The advantages of the technique
was described by Doctor Torsello's group in Munster here, showing that it does in fact reduce the amount of radiation in contrast during these procedures as well as bringing the procedure time down. And this was described by Mark Farber as well
in the experience of the off-the-shelf p-branch devices. We modified the preloaded device a little bit further by taking away that very top stent, and instead of having the loop wire is on the p-branch, just placing catheters through those fenestrations,
but still using the triport handle, and then replacing those with 018 wires to achieve stable positions. Of course, preloaded catheters and wires can then be used for branch procedures as well, as Eric Verhoeven just showed you. And in this case, just using these
indwelling catheters to allowing wires to be snared from above and then advanced into the specific branches and distal arteries. And of course, if you use a fenestrated device for thoraco-abdominal repair, the same applies. And this is from Carlos Timaran's paper
just showing how he places these wires from above in these discrete fenestrations. This is a combined device of a two-branch, two-fen device, if you would like, that has indwelling wires going through the fenestrations and out
through the branches, which we use on occasion. You can then bring that out through the axillary artery, and you get access directly from above to the branches from below for the fenestrations. And we found it very useful in the setting of narrow aortic
lumens and chronic aortic dissections, as in this case. And you can see here, then, on the wires placing the sheath, catheterizing the renals, and then at the same time, having these access catheters in the branches so you don't have to access those for a nice end result.
So in summary, Chairman, ladies and gentlemen, preloaded wire I think reduces the operative time and the X-ray exposure during these procedures. It's very useful, particularly in complex torturous aortas, during redo EVAR cases with preexisting devices, and
compromised iliac access, and in the situations of narrow aortas, like in chronic aortic dissections. Thank you very much.
- Thank you, I've changed the title little bit, instead changes in AA neck morphology after standard EVAR and CHEVAS and they can be subtle and missed. And I'm a co-founder of endovascular diagnostics and my background of my slides is black because yesterday, Teo Fleugus passed away. Teo has served the endovascular fields
for more than two decades and Teo is an iconic and humorous Dutch giant and it's always been a pleasure and honor to work with him. The background of this presentation, slight changes in apposition and position of endograft in aortic neck can be missed
with standard imaging techniques like CT scans and duplex and the follow up imaging nowadays should prevent and should predict complications and not only show complications. That's why we, well we developed software, homemade software for precise determination
of the endograft position and apposition in the aortic neck post EVAR. And it serves, we transport the mesh of the aorta from a standard CT scan and use the 3D coordinates of a 3Mensio workstation and we definitely are able to calculate
and determine almost all the positional changes of the endograft in the neck post EVAR and also calculate the apposition of the endograft in the aortic neck. Well here, you can see some of the changes. The yellow bar is the apposition,
the circumferential apposition of the endograft in the aortic neck and during follow up, you can see that there is a loss of apposition, and of course, you want to avoid there is a complete loss in the patient coming with a type 1A endoleak and a rupture.
But to prove the concept of course, we had to prove that the software could really predict endografts' failure like migration and type 1A endoleak, so we had a co-ord of four groups of patients patients with type 1A endoleak,
patients with migration more than 1 centimeter, and those included 45 patients, then we had control patients without any endoleak or migration. We did a software analysis, so the determination of the apposition and position of the endograft in the aortic neck and we compared in the first
post-EVAR CTA scan and the late CTA scans, and here you can see what we mean with late CTA scan in the patients with type 1A endoleak and migration, it was the CT scan before the CT scan where the complication occurred.
Well, with the new software this is all on the CT scans before the complication in the patient with type 1A endoleak and migration, there is significantly loss of apposition, length, and also in the patient group with migration and the CTs
come before the complication really occurs the apposition is significantly lower. And also, there is more endograft expansion in the patients with migration, the endografts almost have expanded to 100%, and of course then
you will have a seal failure. What about EVAS? It is more challenging to calculate the apposition, so in the software we don't calculate the apposition but the non-apposition surface post
EVAS and post chimney EVAS. Here you can see one of the examples, the red area is the non-apposition, post-EVAS and also here you can see that sometimes it can be very subtle changes if you compare the one month and the
one year CT scan for these graft migrates because there is an increase in non-apposition. There are some different kind of migrations we call it displacement, post EVAS because it's not only a real migration but sometimes the endo backs and the stent frames bow,
and that causes also a kind of migration. And loss of apposition in inter-renal neck. And what is another important thing is you really have to determine the 3D position of the stent frames because here again we have the software usually in red
in the six months follow up, a slight displacement of the stent frames, and during one year, and 18 months here, you can see complete displaced stent frame, well of course again you want to have dealt complication before the complication
really occurs so you want to see it after 6 months. We have 20 patients with chimney EVAS. Five of them suffer a type 1A endoleak during follow up and again, we calculated the non apposition surface but also the other stent frames displacement and as you can see
here on this figure, there is a correlation between the displacement of the stent frames and the chimney grafts itself. Can we also predict (unclear), yes the five patients on the right is at a one-year CT scan, slight movement and displacement,
and here at more than one year, all those patients have type 1A endoleak and even one had a rupture. So to conclude, determination of the position and apposition of the stent grafts post-EVAR is, well it's necessary and we can
miss that with the standard CT scans so we advise to use them, the new software, which can really predict complications post-EVAR and EVAS, thank you very much.
- Thank you again, Dr. Veith, for the kind invitation to talk about this topic. This year, these are my disclosure. In the last five years, we treated 76 cases of Fenestrated and Branched repair for torque abdominal unfit for open surgery. And we soon realized that the upper extremity access
is needed in almost up to 90% of the cases. The first cases were managed by standard cut down in high-brachial and brachial region, but as soon as we improved our skills in percutaneous approach for the groins, we moved also in a transaxillary and percutaneous access
in the area. What we learned from the tanvis group of Hamburg is that the best spot to puncture the artery is the first segment, so the segment within the clavicula and the pectoralis minor. And to do so it is mandatory to use an echoguidance
during the procedure. Here you can see how nicely you can evaluate your axillary artery and avoid puncture the artery through the pectoralis minor where there are nerves and collaterals and also collaterals of the vein. Here is short video you can see I'm puncturing
the axillary artery just below the clavicula with a short guide wire, we introduce 6 French sheath and then we place two proglides according to the instruction for use of the device for the femoral artery. And at the end we usually put a 9 French short sheet
and then we start the procedure. As soon as we are finished with the main body of the, finished with the graft and we have bridged all the vessels from below, we downsize the femoral access but we keep in one groin a 7 French sheath
in order to perform then the final closure. What we do as soon as we are finished the complete procedure we snare a wire from the femoral artery we push the seven French sheath in the axillary artery, we pull back the 12 French sheath in the axillary artery and then we are ready to unlink the two sheath
and so we push a wire in the axillary, from the axillary in the aorta, and one wire in the arm. So that we can deploy a balloon which is sized according to the axillary artery diameter we inflate the balloon and we remove the 12 French sheath and now it is possible to tie the knot of the proglide
over the balloon without any worry to have bleeding and we check with the wire then we remove the wire and then we tie the know of the proglide again. And we ensure that there is no defect and leaking on this region. We have done so far 50 cases and they are
enrolled in this study which is almost completed. And here you can see the results. We have mainly punctured the left side of the axillary, you can see that nicely the diameter of the axillary artery in this region is 8.9 millimeter the sheath size was mainly the 12 French
but we also use sometime the 16 in cases which on iliac was not available. And we also punctured the artery if there was a pacemaker or previous scar for cardiac operation. And here are the results you can see we had no open conversion, the technical success
was 92% of the cases because we are to deploy three cover stent to achieve complete sealing and one bare stent to treat dissection distally to the puncture site. We didn't have any false aneurysm on the follow up and arterial thrombosis and no nerve injuries
in the follow up. So for the discussion, if you look on the research where there are different approach in the discussion is called either to go for the first or the third segment we believe that the first segment is better because it is bigger, is more proximal
and there are no nerves in this region. And by proximalizing the approach you can also work from the right side of your patient so you don't need the guy left side of the table. Moreover, by having the 12 and the standard 19 seven french sheath you can enhance your pushability
here you can see that the 12 french sheath arrives close to the branch of renal artery and the seven french sheath is well within the renal branch. And here you can see where the hands of the operator are. Of course if you enhance this technique you can downsize contra arterial femoral sheath
needed to reach three vessels so maybe lowering your risk of limb ischemia and paraplegia and if you insert this approach in the femoral percutaneous approach, you can see that you can cut down your procedural time your OR occupation time and also
the need of post operative transfusion. So dear chairman and colleagues in conclusion, in our experience the first segment is the way to go. Echo guided puncture is mandatory. Balloon assisted removal is the safest way to do it. Our results prove that it's feasible and safe.
There are different potential advantages over branchial and cutdown. And we hope to collect more data to have more robust data to support this approach. Thank you.
- Thank you very much, Fabrizio. As mentioned, I will talk about the treatment of a type 3b endoleak with an off-label use of a device used in structural heart disease. I don't have any disclosures. I will focus on the type 3b that is caused by
a fabric tear or defect in the fabric, and I will not talk about the graft disintegration. The type 3 endoleak incidence is lower with newer devices, but it has been described with almost all commercially-available devices. And according to literature,
the occurrence can go up almost to 3% of cases. The diagnosis, as I'll show you also with the case, can be quite cumbersome. Often times there is confusion with a type 1 or a type 2 endoleak
that also may be concomitant, and that's where the confusion comes from. The causes are stent fractures, typically suture breakage after implantation of a bare metal stent inside a stent graft or vascular plugs.
And it might also be a manufacturing issue. I'll show you some images from two papers, showing the causes. Usually it's the interaction between the fabric and the metal that makes the fabric tear
and causes the type 3b endoleak as you can clearly see here. Treatment can be very complex, from relining, that might be very challenging, especially when you are very close to the flow divider with the origin of this 3b endoleak. You can put in an aortic cuff
or an iliac limb if that's still possible. Otherwise you need to resort to complete relining using a bifurcated graft, aorto-uni-iliac graft, or off-label use of EVAS. You can also try to seal the fabric tear
by using a pledget in open surgery and something that is similar to the pledget, vascular plug or a septal occluder. And then the final solution would also be conversion. Here are some examples of relining in a bifurcated fashion using an AUI,
which also is a good solution, just like EVAS, as mentioned, off-label. This is an image from a paper from Jones, showing a pledget that was sutured on the fabric tear in an open fashion. And I would like to discuss a patient,
78-year-old male that had a similar problem that was solved by using a vascular plug. This specific patient underwent an EVAR in October, 2009. And then during graft was placed. And a CT in March, 2016 demonstrated a growth of the aneurysm sac,
and also a type 1a endoleak. At least that's what we thought. These are the images from the initial CT scan in March, 2016. You can see a huge filling of the endoleak from proximal. You can see that the stent graft
is actually relatively far away from the left renal artery, which was the lowest renal artery. And on the next pictures you can see that there is actually contrast surrounding the neck, and there is too much space. This was the reason why we decided
to put in an extension cuff in April, 2016. You see some images here. The stent graft was heightened up for about a centimeter or so, and we thought the problem was solved with this. However, a duplex was made,
and to our surprise we saw this image. Flow still in the aneurysm sac from a tiny hole which we thought was a fabric tear. This was actually confirmed by a CT done the same month. And then we planned a procedure. It was relatively easy using the location of the fabric tear
with respect to the marks on the stent graphs to cannulate this tiny hole with a 4 French diagnostic catheter. And you can see on the right-hand side contrast injection clearly demonstrating the 3b endoleak. The sizing should be in such a way
that the device doesn't make the hole that is present a little bit bigger. So we decided to use a relatively small device, 4 French compatible, with a sheath. You can see the sizes, the long axis diameter, that's the A,
the short axis diameter, the B, was three millimeter. And then the unconstrained device length is C, was 6.5 millimeters. And this is actually the segment that will remain inside the aorta, and this is the segment that will go into the aneurysm sac.
And this is actually more or less the thickness of the stent graft. This is a device that is maybe used in the treatment of perivalvular leaks after surgical repair of the aortic valve. But this can also be used,
as I will show you in this case, for this kind of repair of a type 3b endoleak. I put in a 6 French access sheath allowing a 4 French long sheath to move very easily inside. And then we made an exchange of our thicker wire and went inside the endoleak
through the hole with the 4 French sheath. And here you can see advancement of the plug into the aneurysm sac very carefully, because the aortic wall is sitting here. You can see the contrast still being present in the aneurysm sac.
Now with the occlusion it doesn't get out of the sac anymore. Deployment of the distal segment is done first. You can see here the device really popping out, there's a marker on this that indicates the disc that is inside the aneurysm sac now.
Then the proximal segment is deployed by just pulling back the sheath and then you should always test whether it's really holding back by pulling a little bit on the device, and here you can see the device is stretching out.
And the part, the segment inside the aneurysm sac, you can see here with this marker. And this is the other marker on the inside. Then the system is released, you can see the connection still being here connected. And then by unscrewing it you can see
the twisting of the device inside the aorta. And here you can see the segment that is intra-sac. To show it more clearly in the still image, you can see the intra-aortic or intra-stent graft segment, and here is the intra-sac segment. And this occluded the endoleak completely.
Of course, this is off-label use. I show you the image of a follow-up at one year. You can see that there is no endoleak anymore. Actually the space that was here has become a little bit swollen. Sac regression actually didn't occur at this point,
but after two years, you can see that there was sac regression and still absence of an endoleak. So after the type 1a endoleak treatments, it was probably a combined type 1a/3b. With the vascular plug we managed to get
a good and also durable result at two years. This technique has also been described by other people. Richard McWilliams who I saw earlier in the room here used a septal occluder which is a similar device for a similar problem with good outcome. So to conclude,
the diagnosis of type 3b endoleak can be difficult as I demonstrated with this case. There are various endovascular treatment options for relining and embolization with plug-like devices. The occurrence of late type 3b endoleaks underscores again, the need for continuous surveillance after EVAR.
Thank you very much for your attention. (applause) - [Moderator] Thank you Jos. Any questions? Andy, what do you think? - [Andy] Well done, it's fantastic, Jos.
Was there any concern that the wire form of the stent might get in the way and compromise your delivery? - [Jos] Actually that didn't happen, but it was one of my-- - [Andy] You were worried about that, yeah? - [Jos] Yeah, but I got away without a problem, yeah. - [Andy] And cannulating, you said, was surprisingly easy?
- [Jos] It was surprisingly easy, yeah. But I think also here you need to use your pre-interventional imaging. And it was really easy to locate the hole with respect to the markers on the stent graft. And we had quite some of them over there.
- [Andy] I see, of course. Okay, well thanks Jos, that's great.
- Thank you very much (mumbling) and to the chairman. Good afternoon to everybody. We moved immediately to our topic. This is my disclosure. I would like to present you, introduce you, this new stent. They're a really MicroStent. 3.2 French system.
Very, very small, as you can see. And actually, they are available only for retrograde deployment. And very soon, we will have new devices for antegrade deployment. They are made with nitinol.
Two nitinols... Wires, sorry. My mind is, I'm getting older. Two nitinol wire, and they behave exactly as small supera. I can introduce you the case. That is a gentleman with a previous first toe amputation,
non-healing, and I previously recanalized the one month before posterior tibial artery, but this is a patient with a small artery disease. So, you can see here, the angio, this is a CO2 angio. We have a steel patent posterior tibial, but an occlusion, a long occlusion of the anterior tibial.
And you can see how poor is the vascularization in the foot. Of course, this time, the surgeon asked me to try to recanalize the anterior tibial artery, and for us, it became the new target. You can see how difficult is the progression of the wire in the middle of this black calcium
is a very severe calcificated patient. We achieve the rupture of the Asashi Astato 20 wire. So, it was fortunately, we didn't close the tip. We could remove and change in with an Abbott Command ES hook could fortunately, cross the lesion, but you can see here the balloon cannot advance completely
in this terrible calcified patient. So, we applied this technique. We (mumbling) the antegrade wire into a needle. You can see here the advancement of the wire out of the needle. And when we have in our hand the tip of the antegrade wire,
we can pull a little bit the wire in order to achieve the excess. And we can easily pull the system we have. So, after this phase, we can succeed in have a distal access. May I have the audio?
Yeah. There is no audio volume? Okay, so we achieve the retrograde. At full, that was the key. So, the balloon can come with the wire. But normally, does not work like this.
You have to do this. We put the (mumbling) in the stent (mumbling). So, we put the torca device in the proximal part of the wire very close to the cone of the balloon, the cone wire of the balloon so we can fix the torca device in the proximal part,
as you can see. And now we have one system. We have the wire fixed into the balloon, so if we pull the wire, we can pull the balloon. So, this is a system to advance in the severe calcified legion.
In the 90% of case, it work. Of course, if you fail with this system, I don't know how can we do. But after this manipulation, we could predilate successfully all the anterior tibial artery, and now we have the possibility to aggressively
prepare the vessel as we used to prepare the vessel for when we have severe calcification for a superior stent deployment in SFA. The same we used to do in the tibial vessel when we have this kind of calcification. So, I decided to predilate and dilate all the vessel
three millimeters, and the proximal part with aggressively, with a 3.5 millimeter. And you can see here, after the deployment, after the inflation of the balloon, the result was already good, but there was a residual stenosis at the osteum.
So, we repeated the inflation with a longer inflation with this 3.5 balloon, and the acute result, the acute remodel of the artery was really good. So, now the vessel is very well prepared, and if we think to the destiny of this kind of lesion,
we have to expect a restenosis or reocclusion probably due to the recoiling of the calcium, rather than a hyperplasia, or a myointimal hyperplasia. So, you can see here with a sheetless technique, we can insert from the distal access, this micro stent. It's really very clear.
It's very, very well built and projected, and so we can be very precise in the deployment of the proximal part, and you can see the pull out manipulation, but you can modulate the struts. You can pack when you need the struts in order to improve the resistance to the compression.
And you can see how good is the deployment of the stents in the proximal AT. Of course, the manipulation should be very gentle, and when we have the superposition of the two markers that the stent is completely deployed, and so we can achieve very good scaffold
all the lesion in this patient. So, after the deployment, we had a very nice acute result. Look at how good is the flow. And then we decided to continue interdistality in order to achieve some we can call outflow, which is very important.
But of course, this is a patient. We have Roberto in the panel who can be classified as a no-option patient, because the definition is we have clearly a small artery disease, and all the forefoot has no vessel. Look how difficult it was to achieve a reenter
into the dorsalis pedis after several perforation. This was my thought, but (laughs), it was really a war. At the end, you can see here the flow is exact, in the anterior, is exactly the same speed as in the posterior, but as you can see, in this patient,
the distribution system towards the forefoot is completely failed, so probably, the clinical improvement will be not so fine and not so good. But we before shift to the arterialization, of course, we tried to do our best.
You can see here again, the deployment, how clear is the deployment of the stent at the top at the proximal part of anterior tibial in another case. Very, very smooth after a very good preparation. So, again, the crucial key is to prepare very well the vessel in an aggressive way.
Our experience, we only performed seven cases. They're really very, very calcified. We lost some patient, but we checked three patients that are still patent with one occlusion. It's very encouraging and promising procedure. I really believe in this kind of scaffolding
when we have this kind of calcification. We are going to start a prospective study in order to collect more patient, of course. You can see here, this is one of the first patient perform with a very good result. And you can see here the flow in the doppler ultrasound.
So, thank you very much for your attention, and this is (speech drowned out by applause). - [Male] Thanks. Thanks, Marco. Fantastic, Ian. Any quick questions? Just a quick one.
I mean, in terms of distal preparation, can we use experience like supera with, as you say, slight over-dilating to allow it to sit unconstrained? - [Marco] Yeah, in effect, we have to try to oversize the vessel.
As Roberto used to say, the size is important, especially in below the knee. One of the main reasons of the failure of the global impact study was the undersizing of the angioplasty they perform. And when we have this kind of calcification,
of course, we have to try to crack the calcium in some way, and we have, of course, only balloon because it's difficult to think that an atherectomy device can cross this kind of lesion. So, we try to step-by-step to increase the size of the balloon and the pressure,
of course, in order to crack. And probably, probably could be one option for a better patency in this kind of patient. - [Male] Perfect. Just a quick question, Marco. Do you use a one-to-one ratio of this stent
with the (mumbling) vessel diameter? - [Marco] Yeah. - [Male] Or you use an-- - [Marco] Yes, in this case, we deploy the 3.5 millimeter stent after the 3.5 millimeter balloon angiopathy.
Of course, 3.5, it's a quite huge balloon for the proximal AT. Despite in some patient, we have to use this size of the balloon. - [Male] Okay, thanks, thanks very much, Marco.
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