- Thank you very much, chairman and ladies and gentlemen. The funding of this trial was from The Academy of Medical Sciences and The Royal College of Surgeons of England. AKI due to the influence EVAR is actually more common than we all think. This is being shown by prospective studies and registries.
Why is it important? Well, it's associated with a higher intra or inter hospital mortality, cardiovascular events and also long term cardiovascular events and longterm mortality. As even more common and complex, EVAR, and this can range from 22% up to 32%.
These are some of our cases, some of our first, including FEN astrate EVAR in 2010 Thoraco-Abdominal Branch repair 2016 and Fen astrated TEVAR 2018. These are longer procedures, usually with more contrast and direct ventilation after removing arteries.
What are the mechanisms for acute kidney injuries due to infer-renal EVAR? While this involves use of contrast, systemic inflammatory response syndrome, due to ischemic re-perfusion injury, manipulation of the thrombus, aorta and catheterizations which will ------ alpha
and also from high prophalinemia. There is no high-quality evidence for AKI prevention in EVAR. What about Sodium Bicarbonate? Well it's been well know to reduce what been used commonly to reduce CIN in high risk patients in perrifical and
corona graphy. There are two main mechanisms as to how this works. Firstly, from reducing renal tubular ischemia. Secondly, by reducing oxygen deprived free radical formation in the tubules. What is the evidence?
Well this is a met analysis, comparing Sodium Bicarbonate directly with hydration with normal saline, as shown in the orange box. There is no difference. We can look at the population ll
mostly CKD patients or diabetic patients, certainly Hartmann's patients but they are not EVAR patients. They are coronary patients or peripheral an-graphy patients. In addition, serum bicarbonate and the urine pH was not reported so we do not know how effective the Bicarbonate was in these RCT's.
The authors went on to look other outcomes including needful hemo dialysis, cardiac events, the mortality and they found no difference but they concluded the strength of this evidence was low and insufficient. A further Meta-analysis this time published in BMJ this time comes in favor of bicarbonate
but again this is comparing bicarbonate with saline no use of combination therapy. There are again no use of EVAR patients and these patients all have a low eGFR. The preserved trial, a large trial published earlier this year in the New England Journal again using various
treatments again comparing sodium bicarbonates and saline again no difference. But again this compares bicarbonate direct with saline with no combination therapies. In addition, there were no EVAR patients, and these are low eGFR patients.
The met-analysis also showed that by using bicarbonates as a bolus dose rather than a continuous infusion, which was actually the way they used bicarbonates in most of these patients might be better. And using a higher dose of bicarbonate may also be better as shown in this Japanese paper.
So we come to HYDRA trial. They're using a high dose bicarbonate in combination with hydration to protect renal function. We did a UK wide survey of anesthetists of day to day and they felt the best volume expander they would like to use was Hartmann's solution.
So we randomized patients between standard hydration with Hartmann's solution verses standard hydration Hartmann's plus high dose bicarbonate per operatively and low slow intravenous infusion bicarbonate during the surgery. Importantly, with these patients,
we kept the map within 80% of baseline, 90% of the time in contrary to all the RCT's coronary and angeo-porphyry. We're going to skip that slide. This is the inclusion criteria, any patient undergoing infra EVAR, with any renal disfunction,
the primary area you must look at is recruitment and the second area you must look at is AKI. We screened 109 patients of which, 58% were randomized and there were only 2 crossovers. There was a willingness for patients to participate and there was also a willingness for PET 4 Clinitions to
recruit as well. This is the demographics, which is typical of aortic patients they are all on by a few MRSA patients, have normal renal function. Most of the patients wear statins and anti pace agent, only 13% were diabetic.
The patients were matched in terms of hypertension and also fluid hydration pre-operatively measures of via impedance. Here are the results of the trial. The AKI instance in the standard hydration group was like 3% and 7.1% with standard hydration plus bicarbonate. And it was similar in terms of organotrophic support into
and postop and also contrast volume used. It's a safe regime with none of the patients suffering as a result of using bicarbonate. So to conclude, to answer professor Veith's question, about how was this trial different to all the other trials? Well, certainly the previous trials have compared
bicarbonate with saline, there's lack of combination studies that involve mostly coronary an peripheral procedures, not EVAR. And the the most only included patient with low eGFR. HYDRA is different, this is not a regime using high dose bolus of sodium bicarb combined with standard hydration.
It shows promise of reducing AKO. This is an EVAR specific pilot RCT. Again, Unlike previous trials using bicarbonate, 90% of the patients had normal or mild impaired renal function. And unlike previous trials, there's more aggressive management of hypertension intra and postoperatively.
Thank you for listening.
- 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.
- So in terms of overcoming difficult access, when we're doing parallel grafting, and we're going to use more than one branch or parallel graft, typically we come in from the axillary artery. It gives good pushability, it decreases the length for what you need to get from you access point
down to the branch vessels. We find that no conduit is needed. We typically just access this in three offset manners. We'll put a purse string in at each site, so that there's limited bleeding. When you come in, you have to think about
what the aortic arch construct looks like. You can have a type one, a type two or type three arch, which can make things more difficult. As you can see here, this sheath takes quite a significant bend to get down to the renal visceral segment.
You also can have tortuosity within the thoracic aorta, which can compromise your ability to cannulate. So when we think about the arch, you want to think about coming in from the right or left, which ever one makes it better. Typically, if all things are equal,
we'll come in from the left side. When you get your sheaths down one at a time, we leave the stiff wire in to try to straighten out the anatomy. Sometimes you have to snare and get through and through access.
And then you want to think about where your sheaths position is. You want it to be high enough so that you can allow your catheters to form, but also low enough so that you can reach the vessel of interest.
There are a couple of things, I think from a pre-planning perspective that are very important to try to set up, to allow yourself the optimal chance of cannulating these vessels. Appropriate C-arm projections, you want to think about
whether or not your going to use a cephalad or caudad parallel graft. Think about the tortuosity as well as the composition of the branch. What type of stent are you going to use in that? How much purchase is needed?
How much purchase can you get? And, How difficult is it going to be to cannulate these vessels? And also whether or not there's orifice stenosis. So, here's an example of a patient we did. You can see that left renal artery
is actually quite anterior. If you look at the AP view here, you can see how it would be quite difficult to cannulate, 'cause the orifice basically runs into the aneurysm in the AP view, if you just move your II to a 30 degree RAO,
then it becomes very perpendicular and very easy to cannulate and see. This is a situation where you think about periscoping or caudad parallel graft. It's much easier coming from below, it's an upwards approaching renal artery.
Coming from above, you can see it can bow out towards that large aneurysm and also potentially reflux down into infra-renal segment. This is a patient with a very short branch of main renal artery, and you can see if you just put
a typical self expanding stent, there's a higher chance that this thing's just going to pull out into the aneurysm, and what we did here is, we put a balloon mounted stent, followed by a self expanding stent
to lengthen afterwards and it worked out really nicely. And this is just the patient that has significant orifice stenosis and these patients will be hard to cannulate. Sometimes you have to pre dilate before you introduce your stents into the vessels.
You also want to think about the aorta and what configuration of the aorta is. What's the tortuosity, the calcification. Are you in a situation where you're trying to cannulate within the aneurysm and how much thrombus is there as well.
So, you can see here in the first picture, the aorta's somewhat tortuous, and going after that left renal artery probably would be easier, but going after that right renal artery becomes potentially difficult
as the catheters and sheaths are going to be pushing you away, and may make that more challenging. You may want to think about things, and certainly catheters selection before approaching. And definitely, any time you have an aneurysm
and your in a big space without a lot of thrombus, that makes things a little more difficult, 'cause you're flopping around in a large open space trying to cannulate a vessel. When you're accessing the vessel sometimes from above, what will happen is the tendency is
for the catheters and the wires, to reflux down into that infrarenal space. This is a no not well known trick, where you put a coda balloon and you can have your wires and catheters bounce off of that coda balloon
to help you navigate into that branch vessel. Sometimes that doesn't work, and it still continues to reflux, and what we've done more recently is, we'll come in from below, put a four millimeter balloon
in the distal renal artery, and then we'll pin our soft wire, be able to do a catheter exchange, exchange for our stiff wire, and ultimately, there's the catheter, ultimately in the stiff wire.
And then ultimately bring in your stent graft, all with that balloon still in place to hold and pin that wire in position, and allow things to track over that wire, rather than reflux down. Just some general thoughts, again,
thinking about the appropriate catheters, what length catheter do you need, what kind of angulation do you need, stiff versus angle glide wires. We typically use Rosen and Amplatz wires for our stiff wires to track our stents in.
And then different platforms, depending upon what your anatomy ultimately looks like. So in conclusion, a lot of pre-planning is important, I think to optimize your accessing of these vessels. And there's a lot of techniques and technology, that currently exist to help assist with this.
- 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.
- These are my disclosures. So aortic neck dilatation is not a new problem. It's been described even before the era of endovascular repair and it's estimated to occur in about 20% of all patients that undergo EVAR two years after the index procedure.
We're seeing more and more cases where patients that survive long enough after EVAR, they develop aortic neck dilatation beyond the nominal diameter of the endograft and like on this patient, this image, large type 1A endoleaks that are difficult to treat.
There's a number of factors that are contributing to aortic neck dilatation including a continuous outward force that is exerted by the endograft. Progression of aortic wall degeneration. Aneurisymal disease is a degenerative procedure.
The presence of endoleaks, particularly type two endoleaks have been implicated in aortic neck dilatation. And then incomplete seal at the proximal neck in the form of microleaks or positional leaks. HeliFX EndoAnchors as you heard were
designed to stabilize and improve the apposition of the endograft to the aortic neck. And as you saw on this video, their presence even when the super no fixation disengages from the wall of the aorta, may help stabilize the graft onto
the aorta and prevent type 1A endoleaks. About three or four years ago we started looking at the anchor registry data, trying to identify predictors of aortic neck dilatation in patients who are undergoing EVAR with EndoAnchors. We published those results about a year ago.
In terms of the one year mark, we had 267 patients in that cohort. We measured the aortic diameter at four different levels. 20 millimeters proximal to the lowest main renal artery and then at the level of the lowest renal artery, five and 10 millimeters distal to that.
We defined the change in diameter that occurred between the pre-implantation EVAR and the first post-implantation EVAR at about one month. As adoptive enlargement due mainly to the effect of endograaft and the interaction with the aortic wall.
And then we defined this dilatation, what occurred between the one month and the 12 month mark, post EVAR. We used 20 different variables and we ran all these variables at the three levels. And what we found in terms of
post-operative neck dilatation is that it occurred in 3.1% of patients at the level of the lowest renal artery. 7.7% five millimeters distal to it and 4.6% at 10 millimeters distal to it. And this is a dilatation with a threshold
of at least three millimeters. We felt that this was much more clinically relevant. In terms of protective factors for adaptive enlargement, the presence of calcium and the aortic diameter of the level of the lowest renal, both of these are easy to understand.
The stiffer the aorta, the lesser the degree of the immediate dilatation. But then when we looked at the true dilatation, we found out that the aortic neck diameter at the lowest renal artery was a significant risk factor as was Endograft oversizing.
So if you started with a large aorta to begin with, these patients were much more likely to develop neck dilatation and if you significantly oversize the endograft that was also an independent risk factor. On the other hand, the neck length as well as the number of EndoAnchors that
were placed in these patients, both appear to have independent protective effects. So the two year preliminary analysis results is what I'm going to present. The analysis is still ongoing, but now we have a larger number of patients, 674.
We performed the same measurements at the same levels. What we found in terms of time course and location of the aortic neck dilatation is that in the suprarenal site, there is negligible dilatation up to 24 months. The largest dilatation occurs at five millimeters,
but more interestingly, a significant number of patients did not even have endograft present in that location. And then at 10 millimeters distal to the lowest renal artery right where most of the aneurysm changes you would expect to occur,
that change in diameter was again negligible. Indirectly suggesting that EndoAnchors have protective effect. So these are our interesting, some interesting insights. Female sex and graft oversize do play a significant role in the post-operative neck dilatation.
With EndoAnchors implanted at the index procedure neck dilatation 10 millimeters distal to the lowest renal artery appears to be negligible both at 12 and at 24 months. But we're working to see a little bit more finer elements at this analysis.
As where exactly the EndoAnchors were placed and how this was associated with the changes in the aortic neck. We hope to have those results later this year. Thank you.
- So thank you ladies and gentleman, thank you Doctor Veith for inviting me again this year. These are my disclosures. So more effective thrombolysis by microbubbles and ultrasound has been proven actually effective in earlier studies, treating a myocardial infarction or acute ischemic stroke.
But what are these microbubbles? These are 1 to 10 micrometers, gas-filled bubbles with a lipid shell. It oscillate when subjected to low intensity ultrasound, and can cavitate when subjected to high intensity ultrasound. Initially they were designed for diagnostic use
as intravascular contrast enhancers. However, they have many advantages, non-specifical mechanical effects, to induce thrombus breakdown due to mechanical force of microbubbles if they are subjected to ultrasound. So we conducted the first human trial
in peripheral arterial diseases in Microbubbles and UltraSound-accelerated Thrombolysis, the MUST study for peripheral arterial occlusions. Which is a single phase two trial for actually safety and feasibility study. The MUST-TRIAl consist out of 20 patients
for safety and feasibility, which in 10 patients will be treated with Urokinase, and 10 with Alteplase. And then added, for the first hour, microbubbles and we evaluated the VAS pain scores, duplex echography for circulation or revascularization, microcirculation and daily angiography as usual.
Included were men and women 18 to 85 years. A maximum of two weeks of symptoms of lower limb ischaemia due to thrombosed or occluded lower limb peripheral native arteries or venous or prosthetic bypass grafts. And Rutherford class 1 or 2A. They have to understand the nature of the procedure
and written informed consent. And excluded were all known factors that exclude standard thrombolysis therapy, hypersensitivity to contrast enhanced agents, a recent acute coronary syndrome. Endpoints, again, it's a safety
and then a technical feasibility trial. Also we looked at the organisation, and the treatment duration for technical, angiographic, and clinical success. We looked at the severe adverse event and mortality rates, VAS-pain scores and microcirculation.
If the patients came in, we inform them about the MUST trail, we performed an ECG analysis and informed consent. They fill out some questionnaires and when they come in to the angio-room, we started a thrombolysis with a catheter, the Mc Nemara.
And the first group, the Urokinase 10 patients, we treated with 500 units of bolus and then continued with a 50,000 units of Urokinase per hour. The Alteplase group had started with a 5 milligram bolus and then they continued with 1 milligram per hour
for the first 24 hours. And then, the ultrasound room, they got a bubble infusion for the first hour of treatment. Then we would continue with thrombolysis on a surgical ward, every sixth hour we'd look at if there was revascularization at the duplex ultrasound.
And if signs of revascularization are observed on the duplex ultrasound or on the next day, we routinely perform the angiography. Then we could cessate the thrombolytic therapy, and if necessary, acute or elective additional intervention to correct underlying lesions,
or to establish patencies. We check the wound and then we follow-up these patients every six weeks, three months, 6 months, and one year after thrombolytic therapy. So these are the patient characteristics, mostly of these were male, 70 years,
and five of them were native bypass, and five were a bypass occlusion, venous or prosthetic. And two of them had multiple occlusions, whether Rutherford class 1 or 2A. And these were the first 10 patients that were treated with Urokinase and I will present here
the results of these 10 patients first. So, very important, there were no deaths, no severe adverse events, and it was technical feasible. The flow at the duplex examination was there after 24 hours, but most of our patients actually had it already after 6 hours.
The amputation rate, right now, is zero. And also no bypasses were now needed. So we will continue this MUST trial right now and January we probably will have the inclusion of the group with the Alteplase, which I'll present next year.
And we think that microbubbles with Urokinase is a safe combination right now. We will further include the groups of adults placed and further optimalisation of the microbubbles technique with nanobubbles. Had a talk about that yesterday, so you can look it up.
And nanobubbles are nanoparticles of 5 to 500 nanometers, which are very small, they do not penetrate the endothelial barrier of the doubt and it damage. And it can carry the thrombolytics actually to the side the aorta catheter need it. You can also make the magnetic paste,
which means you can paste these patients on the MRI. Then you can have local treatment of thrombolytic therapy. So thank you for your attention.
- Lymphatic, so it's fun, actually, not to talk on venous interventions for once. And, naturally, the two systems are very different. But, on the other hand, they're also related in several ways and I will come back to that later. I have no disclosures, maybe only my gratitude to this man, Dr. Maxim Itkin,
who actually got me started in the field, and was gracious enough to supply me some of his material. And who is also responsible for making our lives way easier over the last years. Because in former times, we needed to do, to visualize the lymphatic system,
we needed to do pedal lymphangiography and that was very, very cumbersome. It took a long time and was very painful for the patient. And he introduced the ultrasound guided intranodal lymphangiography,
and that's fairly easy for most of us. With ultrasound you find a lymph node in the groin, you puncture that and you can control the needle position with contrast enhanced ultrasound and once you establish that position, you might do a MR lymphangiography.
Thereby showing, in this case, a beautiful, normal anatomy of the thoracic duct. I need to say, the variations in lymphatics are extreme. So, you can also visualize, naturally, the pathology, like for example, pulmonary lymphatic perfusion syndrome.
What's going on there. Normally, lymph courses up through thoracic duct, but in this case, you kind of have a reflux in the bronchial tree and lymph leakage. And you can image that again, beautifully with MR, which you can show extensive leakage
of lymph in the lung parenchyma. So you can treat that. How can you treat that? By embolization of the thoracic duct. But first we need to get into there, and that's not a very easy thing to do.
But now, again, with access to a lymph node in the groin, you can push lipiodol, and then visualize the cisterna chyli and access that transcutaneously with a 21/22 gauge needle and then push up a O-18 wire high up in the thoracic duct.
First you deploy some coils to prevent any leakage of glue inside the venous system, and then by microcatheter, you infuse glue all the way down, embolizing the thoracic duct. So, complete different group of lymphatic disorders is oriented in the liver and hepatic lymphatic disorders.
And maybe not everybody knows that, but 80% of the flow in the thoracic duct is caused by the liver and by the intestine. And many times in lymphatic disorders, there needs to be a combination of two factors. One factor is a venous variation of a,
sorry, an anatomical variation in lymph vessels and the other one is that we have an increase in lymph flow. And in the liver, that can be caused by a congestion of the liver, for example, cirrhosis, or a right side, that's congested heart failure.
What happens then is you increase the flow, the lymph flow, tremendously and if you also have a variation like in this case, when the vessels do not directly course towards the cisterna chyli, but in very close contact to the abdomen,
then you can have leakage of the lymph and leakage of proteins, which is a serious problem. So, what is then, to do next? You can access the lymph vessels in the liver by percutaneous access in the periportal space,
and induce some contrast and then later, visualize that one back, visualize that with dye that you can see with an endoscopy, thereby proving your diagnosis, and then, in a similar way,
you can induce lipiodol again with glue, embolizing the lymph vessels in the liver, treating the problem. In summary, popularity of lymphatic interventions really increased over the last years mainly because novel imaging,
novel interventional techniques, new approaches, and we all gained more experience. If you would like, I would guess that, we are at a phase where we were at venous, like 10, 15 years ago. If we are a little bit positive,
then the future is very bright. And within 10, 15 years, we find new indications and probably have much more to tell you. Thank you for your attention.
- 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.
- So, here's the dilemma. We have heard that 20% of AAA occur in women. However, 33% of hospitalizations due to rupture of AAAs are in women and 41% of death due to AAA are women and interestingly, 22% are not even smokers. Ruptures occur in women earlier than in men. We heard before, this is because the aorta, naturally,
is smaller in women. So, if you have a threshold of 5 or 5.5 centimeters, it may be too large for women. So, when AAAs are treated in women, the disease is already more advanced, more complex, with more undiagnosed cardiovascular disease.
AAAs go faster and women rupture rate is 4 times in ruptures with smaller diameters. And this is why the aortic surface index was introduced, to better estimate the time when women need to be treated. EVAR is much less suitable in women than in men, shown here in a meta analysis,
and therefore EVAR is much less frequently offered to women than to men. Is open surgery a solution? No, it isn't. If you look here, the mortality is more than double in women compared to men in open surgery for AAA.
In EVAR, the difference is not as big as for open surgeries. Still, less favorable for women. So, in numbers, women are eligible for EVAR in 34% versus 54% in men. Women are declined for intervention 34% versus 19% in men, and the 30-day mortality is 2.3% versus 1.4% overall,
and using all endoprosthesis available. So, why is that? The neck length is not met in women very frequently, and looking at all IFU criteria for AAA neck, it's even worse. Also, looking at the requirement for access arteries,
they are much less met by women compared to men. So, which EVAR, then, should be used in women to meet that problem? The problem is that women are under-represented in trials. You see here that they only comprise 6 to 29% in the IDE trials with the several aortic endoprosthesis.
So, while women comprise for 20% of AAA, only 10% of the populations in trial were women. So, they are under-represented in these trials. So, what is important for endoprosthesis in a woman? We need a small graft profile for small and also diseased access arteries.
And, because they usually are very calcified, we also need good radial force despite the low profile. So, the Ovation procedure. This is a 14-French device which meets that. And because of those polymer rings, it also helps sealing irregular necks,
also more frequent in women, and the legs have a high radial force. We never observed in our institution, kinks, stenosis, or even occlusions of these legs. The LUCY trial is the only trial every dedicated to this gender problem,
with the twin one randomization, women versus men and 225 patients. And we have now 30 days and one year data available. Not surprisingly, the vascular characteristics were less favorable in women regarding neck length,
regarding angulation of necks, and also the size of access arteries. Now, here you can see the size red are the access arteries sizes for women and blue for men. Also, for the other vascular characteristics, 55% of female patients and 35% of males had
one or more challenging baseline anatomic characteristics. Nevertheless, 96% of females, the prosthesis could be offered, compared to 46 to 75% for competitors. The outcomes, very quick. Because there was no difference regarding procedural outcomes, recovery,
major adverse events at 30 days and also at one year. No difference at all regarding mortality, regarding conversion and rupture, and Type 1a Endoleak over 12 months, and also regarding secondary intervention. So, in summary, the 30-day results of the LUCY trial showed
at least 28% more suitability for EVARs in women with AAA. Only 1.3% severe adverse events, the lowest for EVARs described event rate. No deaths. No proximal endoleaks. No leg occlusions.
Low re-hospitalization rate of 3.9%. 100% procedural success, and at one year, similar outcomes regarding conversion rupture, AAA-related mortality, device-related reintervention. What is good in women with difficult anatomy may be also good in men with difficult anatomy.
This is a gentleman we treated just two weeks ago. As you can see here, very calcified access arteries, four stents in place in the iliac arteries, irregular neck, and that was solved also with an Ovation prosthesis and the Type 1a Endoleak was resolved the following post-dilation.
Thank you very much.
- Thank you very much, Timmer, thanks Manny, thanks Frank for inviting me to this great meeting. I'm going to go through a couple of approaches that most of you know that the retroperitoneal approach is a family of approaches, you can do a paramedian, you can do it from the right side, we use what Mel Williams has described in the past,
what Dhiraj Shah taught me how to do is the extended left posterlateral approach, allows us to access the inframdiaphragmatic aorta fairly quickly. We still do, we do about four to one endo versus open, we still do close to 80 open aortic procedures per year
for varied reasons. The main reason we do it retroperineally, it's a retroperineal structure and I don't have to wade through bowel to get to the aorta once you lift the kidney up and ligate the lumbar branch left renal vein.
You can get the same approach if you go doing hematics or Cattell maneuver and doing, but through transabdominally, but I think that's much more arduous than the approach we're going to describe. It really gives you excellent access to the
estimated celiac routes, not too far out of them, as well as the left and right renal as I'll show you. And it allows you to move your clamp or place your clamp above the renals or between the renals or above the celiac and SMA. And once you divide the left crus, this is how
it makes it fairly easy to see and to sew. We place to patient in the right lateral decubitus position, make a 10th interspace incision, unlike others we do not go into the 8th or 9th. We can get again, good exposure doing it this way. Elevate the left kidney lumbar, ligate the lumbar branch
left renal vein, stick your index finger underneath the crus, and transect it and that will give you excellent access. Keys to this are really positioning the patient with their arm over their chest, usually using an Allen arm rest, and oddly enough,
flexing their left leg at 90 degrees will allow you to get access to the iliac vessels much better by relaxing the Psoas muscle. Here's a diagram for one of our papers on ruptures. We do all our open ruptures, which are only about 25 percent of what we do
for ruptures retroperitoneal, I just find it much easier and quicker and better to get control of the aorta. This is how we position the patient. Again, the incision made from the lateral border of the bilateral rectus up into the 10th interspace and carried in there if you have to do more
cephalad or if you have a broad ribcage. And again, you try to sweep the kidney medially, taking all its attachments off the diaphragm in order to see that the left renal artery's perpendicular, that relaxes the ureter and allows you to get to the aorta.
Here's a couple of pictures, diagrams of what we use. Again, when you, one of the keys is making sure the left renal goes straight up and down, because that will allow you access to the right renal and also allow you access, will take some stretch off of the ureter, which I've actually avulsed
a couple of times in one of my partner's patients. This is a diagram showing the lumbar branch of the left renal vein. Once it's ligated, you can get easy access to stick your finger again into the superrenal and superceliac aorta. Once you do that, especially under rupture,
you can turn your hands over and you have finger control of the aorta without much problem. We use a very low dose of Heparin, about 30 per kilo, once you get the clamp superceliac, you can move down infrarenally. And we use the parachute technique
after we transect the aorta. I'm going to go quickly through, we always transect the aorta if we can, again one of the keys is to take your left index finger and cut, place it between the vena cava and the aorta to minimize vena caval trauma. And this is the parachute technique.
We've done about 350 right renal artery bypasses from the left side, which can be a little bit challenging, but once you know your three dimensional anatomy, you can see, here you can see a picture of the right renal, once you transect the aorta you pull it laterally, place a curved couli on the right renal and it's
fairly stationary to sew. Similarly, we can do a nice trapdoor endarterectomy, this is a patient that we did at two in the morning after she became anuric because she occluded her perivisceral aorta with a plaque. As you can see in this picture, the SMA
coming down the renals look, she had bifid renals on the left, and we did a trapdoor and pulled out the coral reef plaque with fresh thrombus in it. Lastly, unfortunately there are no more easy open cases as most of you know, and sometimes you do
lie awake at night and ask where have I gone wrong and it's going to say it's going to take more than one night to figure this out. Here last two cases is a rupture that one of my partners did. Endovascular then she came back two months later
with an SMA and renal pseudoaneurysm from the infection. This we repaired with a homograft through left retroperitoneal approach, and you can see, have a reasonable amount of visualization of all those vessels through this approach. And lastly, this was a 44-year-old HIV positive
gentleman who came in with a rupture again. We did a temporizing endograft and then repaired it with a homograft through the left retroperitoneal approach. So thank you very much, I just want to say this is a beautiful approach, you can really see what you're doing, you can teach people it,
and you can teach residents, especially when you transect the aorta and see all three layers as you sew it. Thank you very much.
- That's a long title, thank you. We shortened the title, and just said, The Iliac Artery's Complicating Complex Juxtarenal and Thoracal Abdominal Repair. I have no disclosures. So, Iliac artery preservation is important whenever we start doing complex aortic aneurysm repair.
We don't understand completely what the incidence is with these extensive aneurysms. We know with AAAs, anywhere in the 10 to 40% have some sort of iliac artery involvement. It certainly can complicate the management as we get to these more complicated repairs.
Iliac artery preservation may be important for prevention of spinal cord ischemia, and those people in whom we can maintain both hypogastric arteries, it occurs at a less significant rate, with less severe symptoms and higher rates of recovery.
The aim of our study was to evaluate the incidence, management, and outcomes of iliac artery aneurysms associated with complex aortic aneurysms treated with fenestrated and branched endografts. Part of a PS-IDE study over a 15 year period of time,
this is dated from the Cleveland Clinic for the treatment of juxtarenal aneurysms and thoracal abdominal aortic aneurysms. For the purpose of this study, we defined an iliac artery aneurysm is 21 mm or greater as determined by diameter
by our core lab. We chose 21 mm because this was outside of the IFU for the iliac wounds that we had currently available to us at that time. We did multivariable analysis on the number of different outcomes. And we looked at the incidence
of iliac artery aneurysms by repair type. In all the aneurysms we treated, we see about a third of the patients had some level of iliac artery aneurysm involvement. In those patients that had less extensive thoracal abdominals, the type three
and type four abdominals, it occurred in about a third of the cases. A little bit less than the type two and the type one thoracal abdominals. We look at the demographics between those that had iliac artery aneurysm
involvement and those that did not have iliac artery involvement. It was more common in males to have iliac artery involvement than any other group. There are more females that didn't have iliac artery aneurysms. The rest
of the demographics were the same between the two groups. We look at the anatomic characteristics of the iliac artery aneurysms, about 60% of them were unilateral, about 40% of them were bilateral.
The mean iliac artery aneurysm size was 28 mm and that was the same on both sides. And we look at thought the percent that were actually very large, or considered large enough to potentially in and of themselves the repairs
greater than three centimeters. About 28% of them were greater than three centimeters on each side. If we look at our iliac artery aneurysm treatment type, this is 509 iliac artery aneurysms that
were treated out of all these patients. About 46% of them, we were able to obtain a seal distal to the iliac artery aneurysm. So it really only involved the proximal portion, the proximal half of the iliac artery.
20% of them, we placed a hypogastric branched endograft, and about 20% of them, we placed a hypogastric coverage plus embolization of that internal iliac artery. About 13% of them were left untreated at the time for a variety of different operative reasons.
Why is there a difference between the hypogastric coverage and embolization? It was availability of devices and surgeon choice at the time. At one point, we had a opportunity to be able to treat both fairly easily
on both sides and at one point we did not. Larger iliac artery aneurysms were treated with hypogastric coverage or hypogastric branched endografts, and there was a significant difference between the two. Most of the mean
size of those that were actually treated with either hypogastric branch or embolization for greater than three centimeters. If we look at peri-operative outcomes in those without iliac artery aneurysms versus those with iliac artery aneurysms.
We see that the fluoroscopy estimated blood loss is larger for those with iliac artery aneurysms, fluoroscopy time was longer and procedure duration was a bit longer as well. Obviously, a bit more complicated procedure,
more steps that's going to take a little bit longer to perform them. It did not effect the length of stay for these patients or the length of stay in the intensive care unit following the procedures. We look
at all-cause mortality at five years, no difference in whether they had an iliac artery aneurysm or not. It didn't matter whether it was unilateral or bilateral. If we look at aneurysm-related mortality, it's the same whether
they had the iliac artery aneurysm or not. Same for unilateral versus bilateral as well. Where we start to see some differences are the freedom from reintervention. This did vary between, among the three groups. In those patients without an iliac
artery aneurysm, they had the lower reintervention rate than those with the unilateral iliac artery aneurysm, and even lower rates from freedom from reintervention in those that had bilateral iliac artery aneurysms. Spinal cord ischemia, one of the
reasons we try to preserve both the hypogastric arteries. Look at our total spinal cord ischemia incidents. It didn't vary between the two groups, but if we look specifically, the type two thoracal abdominal aortic aneurysms in those patients that had bilateral
iliac arte higher rate of spinal cord ischemia compared to those that did not have any iliac artery aneurysms or those that had an internal iliac, a single iliac artery aneurysm.
So, iliac artery aneurysms affect about a third of the patients with complex aortic disease. They do not, their presence does not affect all-cause mortality or aneurysm related mortality. They are associated with a higher reintervention rate.
In extensive aneurysms, may be higher association with higher spinal cord ischemia rates. We need additional efforts are needed to improve outcomes and understanding appropriate application of different treatment options for patients with
complex aortic disease. Thank you.
- Thank you very much for giving me this challenging title. I have no disclosures. I've discussed the design of the improved trial previously and I think what you need to know for this presentation is that the minimum follow up for re-interventions was three years. Because this was a randomized trial,
we like to keep patients in the rand but because Frank did ask me to talk about type 2 endoleaks after EVAR, I will present data by treatment received as well. Spearheaded by Roger Greenhouse in the EVAR 1 trial,
for the late results, we asked clinicians to rank re-interventions as to whether they were likely to be a life threatening condition or not. We extended this categorization for re-interventions after rupture. You have the three bottom ones on this table
rarely occur after elective surgery. You've seen this slide briefly before. Time to first re-intervention, all re-interventions, and time to first re-intervention for a life threatening condition. What you can see is a very high rate
of re-interventions in the first 90 days, followed by a slower, but really significant rate. And these re-intervention rates are more than twice those recent observe in current series after elective repair. So I've split the re-interventions
into naught to 90 days and three months to three years. The intention to treat the results, because this was a trial, are all (faint speech) shown, but I'm going to focus this talk on the EVAR results. And there, in the first 90 days, we had six re-interventions for endograft rela
, two type 2, and two for kinking. All re-interventions were judged as successful. I'd like you also to notice that in this column, in eight patients there were re-interventions for limb ischemia, the next most common
type of re-intervention. What about from three months to three years? By now there are a number of patients at three months, have reduced to 125. Only it doesn't take much to grasp that by far the biggest finger under the EVAR column
6. Four type 1As, two type 1Bs, 11 type 2s, and one type 3. Please also note that there were two secondary ruptures during this time period, both due to type 1A endoleaks, additional endoleaks.
We're still seeing re-interventions for limb ischemia and still for endograft kinking. What about these type 2 re-interventions? 13 in nine patients, and they're charted here. The first three, intervention a success. The second one, successful to start with,
recurrent type 2 endoleak failure. The patient died from other causes. The fifth patient, three attempts, but no resolution. The type 2 endoleak after over two years, but the patient was alive at five years. The sixth patient, with sac expansion
successfully treated, as were the next two. It's only the one at the bottom where a type 2 endoleak eventually proved fatal, and this was a complex patient who'd had a second re-rupture ... recurrent type 1A endoleak, which had been
successfully treated, but the two had not, and this patient became too frail for general anesthesia, and died of a tertiary rupture 11 months later. So, re-interventions after EVAR ruptures, twice as common, probably, as after elective repair. Endoleaks are common ...
and two secondary ruptures, both due to type 1A endoleak. The other two key points I'd like to get across is that graft infection only was ever observed in fem-fem cross over of AUI grafts, and re-interventions for limb ischemia were relatively common.
So, there are some limitations to this, and that the key outcome of IMPROVE was cost effectiveness. So we recorded re-interventions, but not complications. Narrative details suggest that at least three further EVAR patients were too frail for re-interventions. We've learned some less
a need for quite intensive surveillance after rupture and perhaps consider better surveillance for limb ischemia earlier on. Thank you very much for your attention.
- Frank, thank you very much for your invitation. This is my disclosure. I think that all vascular surgeons are asking ourself following question. Is diameter of triple A the sole indicator for surgery? To ask for this question since about 20 years, we are interesting with function in aging with a PET CT
using 18F-FDG which allows the evaluation of the regional glucose metabolisms. And shows the presence of an inflammatory reaction at the level of atherosclerotic tissue infiltrated by the inflammatory cells. During our pilot study, we observed that
the uptake of the FDG was also stated with the unstable triple A. And during several studies, we were observed that FDG uptake not only show of predicted rupture but it predict also the site of the rupture
in triple A patients in Thoracic Aortic Aneurysms as well as Aortic Arch Aneurysm as you can see. Here is very easily we are find, you can observe FDG uptake and this patient we performed MRI and you can see here, free iron particles, it's same area of every velope. Starting increase FDG uptake
and this patient refused operation and come back three months later to rupture. Of course FDG is not specific for aneurysm or disease. We can found FDG uptake in cancer disease, infection or arthritis or arthritis and reason why several authors interested with different kind of biomarkers
and sodium fluoride F 18 each one of those one. And it's injections indicated for diagnostic PET imaging of bone to define areas of altered osteogenic activity. The primary clinical use of sodium fluoride PET is in detection of osseous prostate cancer metastasis. But some authors, all of them start to use it for
evaluation of the plaque metabolism in high cardiovascular risk subjects. One group from United Kingdom and leaded by a Dr. Newby from Cambridge, they performed several very nice studies using this marker in coronary artery disease for plaque rupture
and for evaluate aortic stenosis to accumulation of the calcification in the aortic leaflets. And also for carotid stenosis and they, during this several studies, they demonstrated that 18F sodium fluoride, selectively binds to microcalcification coronary
and carotid atherosclerotic plaques and that are associated with plaque vulnerability and rupture. More essentially he interested, they interest also the triple A and they called this study the SoFIA study and it concern about 72 cohort patients
and 20 study population. And it is very nice picture of the patients with positive 18F sodium fluoride uptake. It is specific for one and reason why it is left right in red color here, but anyways, very easy to show the infusion images uptake
at the symptomatic aneurysms. And they divided their cohort study in three levels of Tertile 1, Tertile 2, Tertile 3 according to sodium fluoride uptake from low uptake to increase uptake and they observed that the growth rate,
increased growth rate, aneurysm repair and rupture and aneurysm repair alone, it was significantly higher in the patients in Tertile 3 group. And they concluded that Fluorine-18 sodium PET-CT
is a novel and promising approach to the identification of disease activity in patients with triple A and is an additive predictor of aneurysm growth and future clinical events. My conclusion is 18F-FDG and 18F Sodium Fluoride however,
not specific for inflammation. Therefore, new imaging tracer for a more accurate inflammation detection and therapy evaluation are needed. We need specific markers of angiogenesis and inflammation to predict the triple A evolution and potential rupture.
Thank you very much for your attention.
- 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 very much for having me speak and thank you for coming this late in the day for this talk. These are my disclosures. This is our current operating system with advanced imaging and this is GE Discovery IGS 740. You can see you have fusion imaging,
you have the capacity to use combined CT. What I would like to talk to you today is about how we were significantly decrease radiation over the years. What you are seeing on this graph is my personal volume of endovascular cases. In the solid bullets you've the number of fenestrated cases
which have steadily increased over the years and in the empty rounds you've the number of any endovascular case. So what this is saying is that I am doing more fenestrated than more standard endovascular cases. And nowadays these cases are becoming more complex.
You're seeing here the number of vessels incorporated went from 2.9 all the way to 3.7 per patient. Now, at the same time, I did get better over the years. You can see that the fluoroscopy time for the procedures declined after two or three years of experience but it plateaued in 2012.
So, basically, since 2012, I am not doing these cases any faster with any last fluoroscopy time. So any change in the operator or in the patient radiation exposure would be attributed to other factors but the technique. You can see here the effective dose over the years
has dramatically declined from system 1 to system 2 to now system 3 in the blue that is the GE Discovery system to approximately 1/3rd to 1/4th of our baseline dose in the first beginning of the experience. We also recorded the operator dose over the year and you can see here that my radiation dose
has significantly declined again to about 1/3rd to 1/4th of the beginning of the experience. So, how did we achieve this improvement? I will go for eight golden rules, first is doing your work ahead of time, finding out the ideal work positions, using and leveraging all preoperative cross-sectional
imaging that you've, numerous of speakers have already talked about that, our highlights the importance of lead shooting with the work of Dijon which has a thing being remarkable contribution to the understanding of this. Optimize the system geometry, I think is very important avoiding work with the detector too high, the table low
as the abstracted on these illustration or the opposite with the table too high and really finding your way to the optimal geometry. I am sorry I advanceed, the slide is wrong way. Using the ideal dose rate, you can see here that the ideal dose rate in most operators has been down
now to 7.5 frames per second, and in some systems even 3.75 frames per second. We tend to use 7.5, we found this to be the soft spot with our system. ONLAY fusion has been also an important aspect in terms of facilitating the procedure, you're seeing
a segment of a patient before chronic dissection where you're leveraging the fusion to find the septum of trolloming using a reentrance device and really minimizing the amount of contrast and minimizing fluoroscopy, finding your ideal work position or with the use of these landmark markings
than with the fusion. Finally, nice feature of the system is the digital zoom. We really rarely magnify. What you're seeing here is a basically, digitally zoom different than magnification, so that really has allowed us to keep the dose very low
coupled with the collimation. And I think, this is a nice feature. We really avoid using DSAs unless you've to interrogate vessel. It is important to remember that 1 DSA is equivalent to approximately 500 fluoroscopic look.
So, what you're seeing here is the interrogation of a left renal stent done with a fluoroscopic loop as opposed to DSA. And, that is again a very important aspect. Avoiding high angulations wave when you're working in the sma or the celiac axis, we actually tend to that often
with the AP as opposed to the lateral view as soon as you can, you kind of transfer the image to the AP view to minimize radiation. So, in summary, we came a long ways, in terms of standard and complex EVAR where living now in a narrate that we've better devices, we've cross sectional imaging and we've
advanced image and I think we need to leverage all these three aspects to minimize radiation. Thank you very much
- 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.
- First of all let me thank Dr. Veith for the kind invitation to be here again and it's my great pleasure to share with you the preliminary result of our Indian registry. So these are my disclosures. So as vascular surgeon we have to admit that the Fogarty embolectomy has many possibility
but also some limitation. You can see here in this short video that we were able to remove thrombus, but thrombus was mixed up with plaque, hyperplasia and the final result was a very poor backflow from this vessel.
So already a couple of years ago we published our experience comparing the Fogarty embolectomy with the hybrid treatment that at that time was Fogarty plus a lot of endovascular rescue maneuver and of course hybrid was better, but we were very surprised by this.
What we found that the introvert in geography after Fogarty we had a number of chronic disease this is normal, but we also found a number of residual thrombus because firmly adherent to the arterial wall or just not appropriately reached by the Fogarty balloon embolectomy.
Even the over the Y Fogarty balloon embolectomy cannot work enough well. And then finally we also had a number of case with the injuries. Probably from inappropriate Fogarty balloon maneuver into the vessels so we had to find something more.
We had to find something less traumatic and so we realized that at the same time our colleagues from stroke unit, the neurologist had already a very nice tool in their hands. It's the Penumbra system which has began the market leader in stroke because it's very atraumatic,
dedicated for intracranial vessel navigation and then has a very high aspiration power system. So a couple of years later the company came on the market with the family dedicated to peripheral artery, the Indigo System from three to eight French catheter
designed for peripheral artery. So really improved trackability and atraumatic tip of this catheter. So how does the system work? You have already seen this video, but anyway you have first to engage the clot then you switch on
the aspiration power and then from proximal to distal you can remove all the thrombus, you can use the separator guide wire that breaks up the clot when ingested into the catheter and so the final result is that the tip of catheter is all we part and that you can remove all the thrombus
in very few minutes. Now I want to show to you my very first case it was four years ago and the system was not yet available and I for prefer I had some conflicting result with the other with competitors. I have incomplete reperfusion or hemolysis.
I have very positive feedback from my colleagues from the stroke unit at my University. I had the possibility to borrow the neuro catheters. So in this very first patients, unfit for lysis with a lot of thrombus, fresh thrombus in a vein popliteal area and the tibial artery I used
neural catheters, separate was very easy even at the beginning of our experience and we were able to engage the clot use the separator and removing in a couple of passage old thrombus even from the very distal localizations. So up to now we have used the Indigo family,
Indigo system in a lot of situation I can go through all this the one, but I want to show you how far we can go and it's a very challenging situation within dialysis dependent patients with the calcify kink and tibial artery and thrombus in the plantar arch
we were able to reach the plantar arch with the CAT 3 device and remove all the thrombus. Since then we have decided to collect data in a prospective national registry, the Indian registry. We want to collect 150 case in this prospective registry. We started last year and we actually included any kind
of acute lower limb ischemia embolism, thrombosis, graft endograft thrombosis, distal emboli and secondary to preceding intervention or even incomplete reperfusion after Fogarty and lysis. We evaluated the vessel patency by TIMI score of course we have now 136 patients enrolled by 17 centers active
and Ethiological hypothesis of the ischemia was in the 3/4 of case thrombotic, so the most challenging case. Acute and chronic ischemia mainly in very popliteal area or even below the knee or below the ankle in arteries. And here are preliminary result available for 120 patients.
After the Indigo use we already have a 90% TIMI two or three flow restoration will raise up to 96% after additional PTA or stent or additional lysis. So in conclusion these are only the preliminary result I hope to share with you our final result next year,
but at that moment we can already say that the Indigo is safe and effective option for acute lower limb ischemia, technical success is high even in small arteries, and up to now adverse event related to the device is very low and bleeding and hemolysis are not reported.
- 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.
- These are our disclosures. We are indebted to the Society for Vascular Surgery and the FDA and others for funding this work. Many patients who undergo endovascular aneurysm repair will also undergo reintervention. How patient-level factors affect the rate of reintervention, however, is poorly described.
Our goal in this project was to identify factors associated with reintervention after EVR in a large real-world cohort. We studied all patients in the Vascular Quality Initiative from 2003 to 2015 who underwent EVR. We linked these patients to their respective Medicare claims
using some patient-level analyses that were highly successful, making sure that we had identified the same patient in the registry, as well as their respective Medicare claim for followup. And we have had about 14000 of these patients.
We then made sure that we could identify the key events, like reintervention or a late rupture. And we were left with about 13000 patients for analysis. It is important to note in this cohort, amongst these 13000 patients, we had essentially 100% followup
for the outcomes of survival, reintervention, or late rupture. How did we measure these? Well, reintervention Medicare claims was measured using some algorithms that detected any procedure related to the aneurysm or the aneurysm repair
that occurred after discharge from the index hospitalization. And we published these algorithms in this JVS recently. This algorithm was found, upon clinical chart review, to be highly sensitive and highly specific in its ability to identify actual clinical events.
A similar algorithm was used to identify late rupture. What did we find amongst these 13000 patients? Well, on average, they were about 76 years old, 20% were female, 4% were black. At the time of initial repair, about 15% had an aneurysm that was small,
less than five centimeters, about 30% were between five and five and a half centimeters, 24% between five and six centimeters, and 30% of the aneurysms were large, greater than six centimeters. 89% were elective, 7% were symptomatic,
and 4% were ruptured. On the X axis we'll show here time, and on the Y axis the rate of reintervention over time. What we found was that the five year rate of reintervention, as by our definitions, was 21% at five years. Amongst elective patients, it was 20%.
It was higher in symptomatic patients at 25%, and ruptured patients had a 27% rate of reintervention at five years. These differences were all statistically significant. We performed similar analyses grouped by aneurysm size, and found that those with the largest aneurysms
had rates of reintervention that were much higher than those with smaller aneurysms. Similarly, these differences were statistically significant. White patients had rates of reintervention of approximately 20%, while African American patients
had rates of reintervention that were also higher. Again, differences that were statistically significant. We did not fine differences by gender. Both males and females had rates of reintervention about 20%. When we stratified our analyses
by the age at which the initial EVR was repaired, we found few differences here as well. Older patients and younger patients had similar rates of reintervention over time. Late rupture, unlike reintervention, was uncommon, just 3% at five years.
Late rupture, when we measured out to 10 years, remained uncommon, still under 5% at 10 years amongst the cohort of surviving patients. Important to know, though, that 70% of our cohort had deceased by 10 years. Our analysis is obviously limited.
It's limited to Medicare patients alone, and may not represent patients who were younger at the time of repair. And, of course, not all reinterventions are of equal magnitude. But, in summary, one in five Medicare patients
will undergo reintervention after EVR within the first five years of their repair. And reinterventions occur at a rate of about 4% per year, and don't appear to plateau over time, and this trend continues out to about a decade. Urgent operations, African American patients,
and those with larger aneurysms have an even higher rate of reintervention and should receive the most diligent surveillance possible. Our study, we believe, has important implications. While reintervention is common, late rupture is not. And how these factors associated with reintervention
also relate to late rupture still remains undescribed. We believe in the future, better describing the factors that are associated with reintervention after EVR may help patients in their decision making when considering abdominal aortic aneurysm repair.
Thank you very much.
- Good morning, for all of you who got up early. It's a pleasure to be here, thank you Frank for the invitation. I'm going to talk about a problem that is extremely rare, and consequently can only be investigated by putting together databases from multiple institutions, called adventitial cystic disease.
Okay, I have no conflicts. So adventitial cystic disease is an extremely uncommon problem, but it's important because it occurs often in young people. Virtually all series of adventitial cystic disease have fewer than five patients in it,
so they essentially become case reports. And yet it's a very treatable problem. There are several theories about why it occurs, you can see this picture here. The mucin-assisting material that occurs in the popliteal artery region most commonly.
The etiology of that and the origin of that is debated, whether it comes from the joint space, whether it comes from rest, whatever. But it's not really known. In addition, what's not known is the best treatment. There are several options.
Some would advocate just simple aspiration of the cystic material, although it's very viscous. Others simply excising the cyst and leaving the vessel in place. Some both excising and either doing
an interposition graft or a bypass. Early results with every one of these options have been reported, but they're quite variable as far as the outcome. And therefore, we really don't know not only the optimal approach,
but also the best outcome. For that reason, we did a study with 13 institutions on adventitial cystic disease using a technique called vascular low-frequency disease consortium.
Where everybody uses a standardized database and similar collection to act like a single institution. The aim of this study, which is one of 20 that we've conducted over the last 15 years, was to determine first of all what people were doing
as far as current practice patterns, and then look at the outcomes with the different treatment options. And this was published in the Journal of Vascular Surgery. Adventitial cystic disease of any site was identified using both the CPT ICD-9 physician logbooks,
pathology databases, and procedure codes. And then we collected epidemiologic data as well as operative and follow-up data, with our primary endpoints being vessel patency and the need for re-intervention, since amputation is extremely uncommon and rare.
This is the process for the low-frequency disease consortium. Where not only is a standardized database used, but each institution collects their data after getting IRB approval. And then deidentifies it
before sending it to a central server. So there's no way that there could be a security breach. And then we do an analysis of the data. The results of this study were that in the small number of institutions, 15 institutions, 47 patients were identified.
The majority were male, and the majority were smokers. What was interesting to us was that not all are in the popliteal region. And actually there were several patients as you can see, who had upper-extremity adventitial cystic disease, although it's far more common in the popliteal space.
And also there was actually one patient who had adventitial cystic disease of the femoral vein. The symptoms were typically claudication, and ischemic rest pain or tissue loss were quite rare. If you look at the risk factors, smoking, which was probably a comorbidity
and would not be claimed to be the etiology but was present. Other than that, this is a typical distribution of patients with vascular disease. As far as imaging here, you can see a duplex ultrasound
showing the cystic mass and how it typically looks. The majority of patients had a duplex, but also they often had an MRA or CTA as well as an angiogram. And the angiogram was typically part of the treatment paradigm.
This is just the typical appearance of an MRA showing what some people would call the scimitar sign, which is that it's not a typical plaque. And this is a picture of a CT angiogram showing a similar view of a vessel. The results,
so there were some that did not treat only the cyst, but also resected the artery. And either bypassed it, as you can see here, or did an interposition graft,
here's just a picture of one of those. And there were others that just treated the cyst, and either aspirated it alone or resected the cyst and patched the artery. Or did cyst drainage and nothing else to the vessel. If you look at the typical incision of these patients,
this is a posterior approach of the popliteal region. And the small saphenous vein as you can see is marked, and uses the conduit for bypass. The outcomes of these patients were similar as far as length of stay, complications. The one you'll notice is that
two of the five with cyst resection had a complication, so that's a little bit higher. But otherwise they're quite similar as far as the short-term outcomes and results. The main problem, and also if we look at the improvement in ABI,
although cyst resection with bypass had a higher increase in ABI, the rest of the treatments were similar. In other words, the initial outcome was similar with any of those different options.
The one thing you can see circled in red is the patients who had simple cyst aspiration. It was not durable, and consequently they often had to have a second procedure. And the resection of the artery was generally, or bypass of the artery,
generally had better long-term outcomes. The follow-up was 20 months, and here you can see the recurrence and the types of modality of follow-up. So I just conclude by saying that our experience from multiple institutions
is that this is an uncommon problem, that cyst recurrence is very high if aspiration alone is used, and either interposition or bypass is the optimal treatment. Thanks very much for your attention.
- Good afternoon. First of all, I want to thank Professor Veith for his kind invitation. I don't have any disclosures. And effectively surviving a triple A rupture are there any changes of quality of life. The big question is why.
And does the type of surgery affect the quality of life in fact in patients. I'll begin when we had operated a 63 year old male from ruptured triple A and on routine examination after three months in the office, his daughter was seriously worried about her father and she was
talking about like he didn't resume his work because he is far from the hospital and he was afraid. And he is not the either the same guy like before the intervention. And so it all begins. This is why we had to review our ruptured aneurysm
between 2012 and 2017, and there were like 31 patients operated for ruptured triple A, 25 survived. The mean age was 67 years old, predilection of male predominance, and all cases were hypotensive. 13 patients were diabetic, almost 40% and all had severe pain.
No history retrospectively of anxiety disorders or clinical signs of depression. The mean operating time was around like 150 minutes. The hospital stay varied between one week and three weeks. The ICU stay between like three days to one week. And all patients survived intervention.
Five patients died in the hospital, Two from myocardial infarction, one from complicated late diagnosed colonic ischemia and two from severe pneumonia. And one patient died after thirteen months. So, patients were called to follow up
and to fill a questionnaire that we had modified a little bit. And at the same time, one close family member was called to fill the same questionnaire and both results were compared. And if taking all these results filled by the patient
only few of them reported change in their quality of life and in developing anxiety disorders. But when we look to the answers filled by the close family member, the results were very different. So four patients did not resume their work until seven to eight months because they were afraid to drive.
And two patients developed like severe OCD. One, he was doing like A CAT scan every month so he was afraid that he will have the same pathology and one he had done like he's going to emergency room for every abdominal pain. And seven patients develop like moderate depression
and never went out until three to four months after surgery, and they still have severe anxiety disorders and have been treated by the family physician. And two patients develop severe depression and lost their work and have been treated by a psychiatrist. So overall, 15 out of 25 have described a change
in their quality of life and for at least eight months. And we look back for patients operated for ruptured triple A by EVAR. We have 11 patients and not all patients operated by the same team because we have a problem and administrative issue and a logistical issue.
And results were in favor of EVAR for the first three months because patients with every month they are complaining less when they are discharged from the hospital for the first three months. But for the long term, after three months symptoms like behavioral problems were almost similar
even though the theory is not almost or almost equal. So, and going further into details in both groups we tried to find a correlation between the medical condition and post operative symptoms. And we have remarked that we don't know
if there is any proof of that, but male predilection, diabetes, hypotension at presentation ICU stay more than 72 hours, and age less than 70 years old and hemoglobin presentation was less than ten grams. So, if you look into data and international papers we found that there is many factors and there is
very controversies concerning ruptured triple A either operated by open surgery or EVAR. And the one thing that we knew that vascular pathology is really correlated with psychiatric and anxiety disorders even in post operatively.
So in conclusion, there is still many controversies concerning triple A rupture and its social and psychological effects. Quality of life appears to be affected by many factors related to the disease. But in fact type of surgery, we think that open or EVAR
affects quality of life in the early post operative period and when we have the long follow up, almost they are the same. A close follow up by specialists is necessary for at least six months period post operatively, and of course we need a large quiet trial to confirm
the results and emerge recommendation. And finally, ladies and gentlemen, Mr.Chairman, since quality of life has an impact on human dignity, our mission as surgeons is not only to treat people but to provide them also a good quality of life. Thank you very much.
- Mr. Chairman and dear friends, I would like to thank Frank Veith for his very kind invitation. I will talk about the value and the limitations of the very rare inflammatory disease. I have no disclosure. You see the list of the inflammatory
and infectious disease which are not very often we are used to make EVAR repair. I would like to show you my cases and some examples from the literature to make and emphasize the limitations and complications while doing EVAR
for those rare cases. Behcet's Disease, as we know, has a 30 to 55% percentage of pseudo-aneurysm after surgery, and we know that EVAR has less wall stress and less cytokine release and causing
inflammatory response. And we know that they need to use immunosuppressive drugs. I have a case 45 years old female, had three times open surgery, but again, she had a pseudoaneurysm rupture here and then we had done the EVAR repair
and put a tubular endograft, and the follow-up we had seen that all the hematoma was absorbed and the retroperitoneal space was clear. This case is 50 years old female, Behcet's Disease, juxta-renal aneurysms
at the orifice of the visceral arteries. We planned to make a bypass and also endograft intraoperatively, but she needed the re-intervention because of the distal endoleak and she also had an occlusion of the left renal artery.
But during the follow-up we had seen that she also is active during all the time, although she had drug use. Another case is referred for us from another center, having a pseudoaneurysm at the distal part. We used AUI endograft, fem-to-fem bypass graft,
and a very good result with the CT examination. And this case is from the literature showed that, had a pseudoaneurysm EVAR technique with tubular endografting, but also another pseudoaneurysm, hidden aneurysm, and they had to make an open surgery repair because of the
polar artery of the right kidney. Systemic lupus erythematosus is a vasculitis involving vaso vasorum, and forming the aneurysm formation, three out of antiphospholipid antibodies, chronic steroid, and cystic medial degeneration caused acceleration of this premature atherosclerosis
and the sharp pain of the chain pest and the abdomen is very important for causing the dissection. These are the cases from the literature. Very good EVAR treatment, but these two cases has a catastrophic result of the rupture and they died.
So it's very important for emergency departments to be aware of the young patients having history of hypertension and using a long steroid using. This is our case, which had the dissection aneurysm and the rupture of the aneurysm,
and she had endografting, so we followed her for a long time. This case is interesting. Because of having a penetrating ulcer, circular aneurysm, during the procedure there's a plaque rupture with the,
left common iliac, external iliac. We put a bare stent and also suture failure. Takayasu is another rare disease. This is the multiple aneurysms of the thoracic and abdominal, and this is our case which had two times rupture,
and the second time we offered him to have a TEVAR and surgery, but he refused and died. This is a rheumatoid arthritis disease patient. We had done EVAR successfully. There's no problem. And tuberculosis is another very important
infectious, mycotic aneurysm. The patient was under immunosuppressive and had an aneurysm treated with EVAR technique. And this patient, our own has, was active tuberculosis. We had to put a AUI endograft,
but it was infected. We have to remove and complete with axillary-femoral bypass. There's a lot of limitations as you hear, and as a conclusion, these rare inflammatory disease, they benefit from EVAR,
but we have to be very careful and be aware of the limitations and complications, and they have to be monitored very closely. Thank you.
- Thank you very much Tony, It's an honor to be part of this distinguished faculty. This is a landmark paper that truly revolutionized the management of Iliac vein disease, and you can see in this great experience of Doctor Raju and Neglen,
that primary disease, May-Thurner syndrome, can be treated with a secondary patency of 100% at five years and even in post traumatic patients, the secondary patency rate in this series was 86%. Now it was not immediately recognized that Contralateral Deep Vein Thrombosis is a problem.
In this paper, the authors mentioned that Contralateral Iliac Vein Thrombosis was generally benign and infrequent, 1%. The same group however with increasing experience recognized that some patients, who undergo Iliac Vein stenting have a problem if the stent is extended into the iliac vein.
And they did a comparative series where one group included wallstents that were extended into the inferior vena cava because of the underlying anatomy to correctly treat the disease. And the control group had Z-Stent on top of the wallstent which as you could see in the previous presentation
has much larger gaps between the metal struts. Wallstent in critical areas like under the compression of the right common iliac artery or even the groin can be compressed because of the construction of the stent. And you can see that there was a significant difference from Ipsilateral Deep Vein Thrombosis
if you used a stronger Z-Stent than if you used just a wall stent. But obviously the important finding is that there was a significantly higher rate of Contralateral Deep Vein Thrombosis if you extended the wall stent without protection
of the Z-Stent. Now there are additional papers that have come out since this publication. This is a combined European experience that, oh no actually, this is just the conclusion of the study that obviously
the Z-Stent modifications provides protection. But this is the European experience that only show that 4% had identified multiple factors in addition to extension like Acute disease, previous Contralateral Deep Vein Thrombosis or non-compliance with anticoagulation.
This paper however didn't really differentiate between extension and coverage, complete coverage of the Contralateral outflow. This is another paper from Dr. Gillespie group that again, thought that those patients who were non-compliant with anticoagulation,
those had an increased risk of Contralateral Deep Vein Thrombosis. Now this is a very important paper. It's 111 patients that was just recently published in the Jvir What is interesting in this patient
that Contralateral Deep Vein Thrombosis developed in 10 patients at a median time of 40 month after the operation. And I think that's very important. That this is not an early complication. This is a late complication.
And it's obvious from their findings, that you may not find a significant difference as long as you partially cover the iliac vein. But if you completely cover the iliac vein, 32% of these patients had Contralateral Deep Vein Thrombosis with a significant difference.
We found that in our experience too that when we explanted a stent that the outflow was practically already halfway thrombosed and you can see the pseudointima that really depends on the poor size of the stent. And that's why actually any stent
that has this small size has a problem. And so we called to abandon on extending the wallstent into the inferior vena cava. I think the take home message now that you should remember is that overextension of the iliac vein stent into the IVC and completely covering the inflow
from the Contralateral Iliac Vein is obviously a clear and present danger of delayed, not early, delayed Contralateral Deep Vein Thrombosis. Thank you.
- [Presenter] Thank you very much, Mr. Chairman, and ladies and gentlemen, and Frank Veith for this opportunity. Before I start my talk, actually, I can better sit down, because Hans and I worked together. We studied in the same city, we finished our medical study there, we also specialized in surgery
in the same city, we worked together at the same University Hospital, so what should I tell you? Anyway, the question is sac enlargement always benign has been answered. Can we always detect an endoleak, that is nice. No, because there are those hidden type II's,
but as Hans mentioned, there's also a I a and b, position dependent, possible. Hidden type III, fabric porosity, combination of the above. Detection, ladies and gentlemen, is limited by the tools we have, and CTA, even in the delayed phase
and Duplex-scan with contrast might not always be good enough to detect these lesions, these endoleaks. This looks like a nice paper, and what we tried to do is to use contrast-enhanced agents in combination with MRI. And here you see the pictures. And on the top you see the CTA, with contrast,
and also in the delayed phase. And below, you see this weak albumin contrast agent in an MRI and shows clearly where the leak is present. So without this tool, we were never able to detect an endoleak with the usual agents. So, at this moment, we don't know always whether contrast
in the Aneurysm Sac is only due to a type II. I think this is an important message that Hans pushed upon it. Detection is limited by the tools we have, but the choice and the success of the treatment is dependent on the kind of endoleak, let that be clear.
So this paper has been mentioned and is using not these advanced tools. It is only using very simple methods, so are they really detecting type II endoleaks, all of them. No, of course not, because it's not the golden standard. So, nevertheless, it has been published in the JVS,
it's totally worthless, from a scientific point of view. Skip it, don't read it. The clinical revelance of the type II endoleak. It's low pressure, Hans pointed it out. It works, also in ruptured aneurysms, but you have to be sure that the type II is the only cause
of Aneurysm Sac Expansion. So, is unlimited Sac Expansion harmless. I agree with Hans that it is not directly life threatening, but it ultimately can lead to dislodgement and widening of the neck and this will lead to an increasing risk for morbidity and even mortality.
So, the treatment of persistent type II in combination with Sac Expansion, and we will hear more about this during the rest of the session, is Selective Coil-Embolisation being preferred for a durable solution. I'm not so much a fan of filling the Sac, because as was shown by Stephan Haulan, we live below the dikes
and if we fill below the dikes behind the dikes, it's not the solution to prevent rupture, you have to put something in front of the dike, a Coil-Embolisation. So classic catheterisation of the SMA or Hypogastric, Trans Caval approach is now also popular,
and access from the distal stent-graft landing zone is our current favorite situation. Shows you quickly a movie where we go between the two stent-grafts in the iliacs, enter the Sac, and do the coiling. So, prevention of the type II during EVAR
might be a next step. Coil embolisation during EVAR has been shown, has been published. EVAS, is a lot of talks about this during this Veith meeting and the follow-up will tell us what is best. In conclusions, the approach to sac enlargement
without evident endoleak. I think unlimited Sac expansion is not harmless, even quality of life is involved. What should your patient do with an 11-centimeter bilp in his belly. Meticulous investigation of the cause of the Aneurysm Sac
Expansion is mandatory to achieve a, between quote, durable treatment, because follow-up is crucial to make that final conclusion. And unfortunately, after treatment, surveillance remains necessary in 2017, at least. And this is Hans Brinker, who put his finger in the dike,
to save our country from a type II endoleak, and I thank you for your attention.
- Thank you, Frank, for this really appreciated invitation and to report what factor will be predictive for long-term survival after ruptured AAA treatments. I have nothing to disclose. We know the major key points when dealing with emergent AAA rupture treatment are related to its feasibility, short, and long-term outcomes.
The increase of endovascular repair of ruptured AAA is the proof that most of patient can be addressed by endovascular tools, even if ruptured AAA. We have observed the same trend at USZ with almost 100% of emergent EVAR for ruptured AAA. A third randomized control trial didn't show
any significant differences in terms of short-term outcomes. We know that the real-life studies and meta-analysis are really in favor of emergent EVAR for ruptured AAA. This is consistent with the experience at the USZ. About the long-term outcomes, randomized control trials and the single-center studies did not
show significant differences. We all know that the risk that for conventional open surgery, the risk factor has been clearly identified but we don't know such factors for emergent EVAR. For this purpose, we conducted a retrospective analysis
of ruptured AAA addressed by emergent EVAR and included 242 patient in order to identify factors that can influence long-term survival after emergent EVAR. We have observed this parallel graft did not significantly influence long-term outcomes after emergent EVAR as well as the type of anesthesia,
although the local anesthesia did better for short-term outcomes. Neither the sex was significantly associated to the long-term outcomes, nor the type of stent graft employed. Conversely, shock was significantly associated
to reduced long-term outcomes, as well as re-intervention and open abdomen treatments. So in conclusion, the predictive factors of long-term survival after emergent conventional open surgery are already well-known, but similar factors for emergent EVAR
needs to be identified. We were able to identify that shock, re-intervention, and open abdomen treatments are related to a reduced long-term survival. To improve such outcomes for emergent EVAR, we use five management key points.
About time, we all know that most of the patient who reach alive the hospital are enough stable to undergo a CTA and evaluation for emergent EVAR. This time we go for permissive hypovolemia and controlled hypotension. We try to perform the case faster as possible.
About imaging, we always go for preoperative CTA just to confirm diagnosis, but especially to plan the case. We go for a post-surgery CTA control to immediately understand and realize if there is some trouble with the treatment. We had also started a program with patient-specific ratio
that gives you some tools to perform better ruptured AAA cases by EVAR. This is a feasibility study with good outcomes. About device and techniques, of course to perform emergent EVAR, we need to have all the available
off the shelf devices ready to use. As a general principle, for short and angulated neck, we go for transrenal devices but when there is no neck we go for parallel graft. We are quite aggressive with the management of abdominal compartment syndrome,
not only for emergent EVAR but also for conventional open surgery. Clearly there are some limitations to emergent EVAR. In fact, it's inappropriate in rupture pararenal requiring suprarenal endoclamping for hemodynamic stabilization
and patient presenting too many technical challenges. These patients should probably be treated by fast-track open surgery. Thank you for your time.
- 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.
- Thank you very much. After these beautiful two presentations a 4D ultrasound, it might look very old-fashioned to you. These are my disclosures. Last year, I presented on 4D ultrasound and the way how it can assess wall stress. Now, we know that from a biomechanical point,
it's clear that an aneurysm will rupture when the mechanical stress exceeds the local strength. So, it's important to know something about the state of the aortic wall, the mechanical properties and the stress that's all combined in the wall.
And that could be a better predictor for growth and potential rupture of the aneurysm. It has been performed peak wall stress analysis, using finite element analysis based on CT scan. Now, there has been a test looking at CT scans with and without rupture and given indication
what wall stress could predict in growth and rupture. Unfortunately, there has been no longitudinal studies to validate this system because of the limitations in radiation and nephrotoxic contrast. So, we thought that we could overcome these problems and building the possibilities for longitudinal studies
to do this similar assessment using ultrasound. As you can see here in this diagram in CT scan, mechanical properties and the wall thickness is fixed data based on the literature. Whereas with 3D ultrasound, you can get these mechanical properties from patient-specific imaging
that could give a more patient-specific mechanical AA model. We're still performing a longitudinal study. We started almost four years ago. We're following 320 patients, and every time when they come in surveillance, we perform a 3D ultrasound. I presented last year that we are able to,
with 3D ultrasound, we get adequate anatomy and the geometry is comparable to CT scan, and we get adequate wall stressors and mechanical parameters if we compare it with CT scan. Now, there are still some limitations in 3D ultrasound and that's the limited field of view and the cumbersome procedure and time-consuming procedures
to perform all the segmentation. So last year, we worked on increased field of view and automatic segmentation. As you can see, this is a single image where the aneurysm fits perfectly well in the field of view. But, when the aneurysm is larger, it will not fit
in a single view and you need multi-perspective imaging with multiple images that should be fused and so create one image in all. First, we perform the segmentation of the proximal and distal segment, and that's a segmentation algorithm that is
based on a well-established active deformable contour that was published in 1988 by Kass. Now, this is actually what we're doing. We're taking the proximal segment of the aneurysm. We're taking the distal segment. We perform the segmentation based on the algorithms,
and when we have the two images, we do a registration, sort of a merging of these imaging, first based on the central line. And then afterwards, there is an optimalisation of these images so that they finally perfectly fit on each other.
Once we've done that, we merge these data and we get the merged ultrasound data of a much larger field of view. And after that, we perform the final segmentation, as you can see here. By doing that, we have an increased field of view and we have an automatic segmentation system
that makes the procedure's analysis much and much less time-consuming. We validate it with CT scan and you can see that on the geometry, we have on the single assessment and the multi assessments, we have good similarity images. We also performed a verification on wall stress
and you can see that with these merged images, compared to CT scan, we get very good wall stress assessment compared to CT scan. Now, this is our view to the future. We believe that in a couple of years, we have all the algorithms aligned so that we can perform
a 3D ultrasound of the aorta, and we can see that based on the mechanical parameters that aneurysm is safe, or is maybe at risk, or as you see, when it's red, there is indication for surgery. This is where we want to go.
I give you a short sneak preview that we performed. We started the analysis of a longitudinal study and we're looking at if we could predict growth and rupture. As you can see on the left side, you see that we're looking at the wall stresses. There is no increase in wall stress in the patient
before the aneurysm ruptures. On the other side, there is a clear change in the stiffness of the aneurysm before it ruptures. So, it might be that wall stress is not a predictor for growth and rupture, but that mechanical parameters, like aneurysm stiffness, is a much better predictor.
But we hope to present on that more solid data next year. Thank you very much.
- I will approach the subject slightly differently and leave the EVAR trial alone since it seems to be pretty heavily on trial here today. So a large abdominal aortic aneurism, it's like a time bomb, and the thing you probably want to know first is what is the time left on the clock, meaning what is the rupture risk of the aneurism?
It's been said that unfit patients usually die of other reasons than aneurism rupture, so I want to remind you of our study from Helsinki, on unfit patients from some years ago. We had 154 patients who were declined from elective operative treatment.
They had significant comorbidities, which were also the reasons for exclusion from treatment. As was expected, majority of them died during the little less than two years of a follow up. Looking at the reasons of death, somewhat unexpectedly, aneurism rupture was the leading cause of death
in all three size groups and taking a closer look on the determination of causes of death, indeed, aneurism rupture deaths were confirmed either at autopsy or in the hospital at the time of rupture. Whereas for the other causes, the accuracy was not as solid and this could mean that even some
of the rupture deaths have been missed. The risk for rupture increased with aneurism size and the medium time to rupture was the shorter, the larger the aneurism, and there was not so much difference between the two biggest groups, over 60 and over 70 millimeters.
So therefore, for unfit patients, probably the threshold for treatment should be slightly higher, like 60 millimeters. When further considering treatment, you probably want to know the physical condition and the functions of the vital organs.
Respiratory, cardiac and kidney functions are something to consider, and, of course, the brain. Today, standard EVAR can easily be done under local anesthesia, so for the procedure, these really are not reasons for exclusion. So the thing left to consider is the brain
and the patients mental and overall condition. When assigning and especially when declining treatment, it is required to have a discussion with the patient and possibly their relatives. These unfit patients are often elderly and sort of on their final road trip. The challenge is to weigh the patient's life expectancy
and what is more important, the quality of life. We nowadays know that age is not the issue, but rather the prospects of the future. Is it a clear view with significance and purpose, or a gloomy view that would rather end sooner than later. Of course the decision is not this clear cut.
But, EVAR should definitely be considered for the patients on the sunny road. On the other hand, if by preventing rupture, you're not preserving quality of life, conservative treatment should be chosen. Then also the possibility of rupture
should be considered, for at the time of rupture, the starting point should be to think that is it possible to return to the sunny road? If not, maybe then palliative care is the way to go. If yes, it should be also considered is laparotomy needed and possibly ICU care, because this would mean
that general anesthesia and possibly open abdomen and then it's a whole different procedure than EVAR under local anesthesia. If the answer is yes, this would favor palliative care. If not, if you, for example, have a stable patient with a contained rupture and you can treat him or her
with EVAR under local anesthesia, I'd say, why not? So my conclusions are the decision should always be done individually. But, in general, an unfit patient should undergo EVAR when the aneurism is over 60 millimeters and there is quality of life to preserve,
and at the time of rupture, when recovering to quality life can be considered possible. Thank you.
- 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.
- [Doctor] Thank you Tom and thanks Dr Veith for the invitation to be here again. These are my disclosures, so hypogastric embolization is not benign, patients can develop buttock claudication, higher after bilateral sacrifice, it can be persistent in up to half of patients. Sexual dysfunction can also occur, and we know that
there can be catastrophic complications but fortunately they're relatively rare. So now these are avoidable, we no longer have to coil and cover in many patients and we can preserve internal iliac's with iliac branch devices like you just heard. We had previously published the results of looking from
the pivotal trial, looking at the Gore IBE device with the six month primary end point showing zero aneurysm-related morality, high rates of technical success, 95% patency of the internal iliac limb, no type one or type three endoleaks and 98% freedom from reintervention. Importantly on the side of the iliac branch device, there
was prevention of new-onset of buttock claudication in all patients, and importantly also on the contralateral side in patients with bilateral aneurysms that were sacrificed, the incidents in a prospect of trial of the development of buttock claudication was 28%, confirming the data from those prior series.
And this is in line with the results of EVAR using iliac branch device published by many others showing low rates of mortality, high rates of technical success and also good patency of the devices. In press now we have results with follow-up out through two years, in the Gore IBE trial, we also compared
those findings to outcomes in a real world experience from the great registry, so 98 patients from the pivotal and continued access arm's of the IBE trial and also 92 patients who underwent treatment with the Gore IBE device in the great registry giving us 190 patients with 207 IBE devices implanted.
Follow-up was up to three years, it was an longer mean follow-up in the IDE study with the IBE device. Looking at outcomes between the clinical trial and the real world experience, they were very similar. There was no aneurysm-related mortality, there was no recorded new-onset ipsilateral buttock claudication,
this is all from the IDE trial since we didn't have that information in the great registry, and looking at the incidence of reinterventions, it was similar both in the IDE clinical trial experience and also in the great registry as well. Looking at patency of the internal iliac limb, it was
93.6%, both at 12 months and 24 months in the prospective US IBE pivotall trial and importantly all the internal iliac limb occlusions occurred very early in the experience likely due to technical or anatomic factors. When we look at the incidence of type two endoleaks, we had previously noted there was a very high incidence of
type two endoleaks, 60% at one month, this did tail off a bit over time but it was still 35% at two years. A total of five patients in the pivotal IBE trial had a reintervention for type two endoleak through two years, and despite that high incidence of type two endoleak, overall the incidence of aortic aneurysm sac expansion
of more than five millimeters has been rare and low at two and nine percent at 12 and 24 months, and there's been no expansions of the treated common iliac artery aneurysm sac's at either 12 or 24 months. Freedom from reintervention has been quite good, 90.4% through two years in the trial and most of these
re-interventions were type two endoleaks. We now have some additional data out through three years in about two thirds of the patients we have imaging data available now through three years in the pivotal IBE trial, there have been no additional events, device related events reported since the two year data and through three years
we have no recorded type one or type three endoleaks, no aneurysm ruptures, no incidences of migration, very high rates of patency of the external and internal iliac arteries, good freedom from re-intervention and good freedom from common iliac artery aneurysm sac enlargement. And I think, in line with these findings, the guidelines
now from the SVS are to recommend preservation of the internal iliac arteries when ever present and that's a grade 1A recommendation, thank you.
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