- I'd like to now take a fast-forward to 2018 and describe to the audience right now the US military's role in what we are referring to as a National Trauma Action Plan to increase both homeland security and our country's response to mass casualty events. I have no relevant disclosures to this,
the content of this talk. So the backdrop for the next five or 10 minutes is really depicted here, the military's experience during a prolonged period of combat in Southeast Asia and the the Middle East, in Iraq and Afghanistan.
And if this wartime experience has shown us one thing, or reminded us of one thing, it is that it confirms that force protection measures, no matter how much we try to prevent injurious events with force health protection, training and preventative measures, it doesn't work all the time,
and there needs to be a trauma care system at the ready, well oiled, well prepared, well resourced to reduce death a disability after severe injury does occur. So the military's role in translating its lessons to the civilian trauma sector can be at least encapsulated, in part, in this Journal of American College of Surgeons
publication that was really lead by Eric Elster, my colleague to the left, but also is co-written by David Hoyt and Peggy Knudson, John Woodson also, who's a vascular surgeon and frequent attendee of this meeting, as well. And in this shared ethos manuscript,
this group outlines for the first time, a renewed and formalized strategic partnership between the Military Health System and the American College of Surgeons. It's in this strategic partnership between the Military Health System
and the American College of Surgeons, that lines of effort, very specific lines of effort were laid out with which to integrate military surgery, the lessons learned into the civilian sector. Some of these lines of effort, for example, relate to readiness of military providers
with high acuity patients and procedures, maintenance of high degree of quality within the Military Medical Health System and then research and development. And these are sort of the pillars that underpin the military's involvement
in a national trauma action plan. There are three facets that you can think of, one can think of is how the military is currently today integrating into this National Plan. One is by the military care for injured civilians. So there are military medical providers
in many of your civilian institutions now, your trauma centers, trauma systems, working with high acuity patients, and there are three or four different models to this approach now that is congressionally mandated by more than one recent National Defense Authorization Act.
So that's one facet of military's integration. The second is the military's research investment that results in products, knowledge products and new technologies for civilian trauma care. Short of the military's investment in trauma research, the NIH and other federal agencies invest very little
in trauma and injury research and national preparedness. So the military or the DoD's research investment is a second facet of our integration into this plan. And then thirdly, the DoD is working with other federal agencies to improve preparedness and readiness.
This includes the FDA, which is part of the Health and Human Services, Homeland Security, the FBI, which is part of the Department of Justice, et cetera. So these are the three facets of the military's role. We've written about the first facet in USA Today,
this is a commentary that was published less than a year ago that really outlined the partnerships in civilian trauma systems and centers. Again, I mentioned, there's now congressional mandate behind integrating military surgeons and providers, not just surgeons into civilian centers and systems,
as this aspect of the partnership. And what we outlined in this commentary in USA Today, was that the military that is assigned to civilian centers or military trauma facilities themselves, military treatment facilities that are level I centers, operating as level I trauma centers,
increase the national surge capacity following mass shooting, natural disasters such as hurricanes, and then large scale accidents such as the Tacoma train derailment, most of those injured were actually taken to Madigan Army Hospital, as an example.
The mass shooting in the church in Texas, over 50% of those casualties were actually taken to a military medical center and so forth. So we outline this integration in this sort of commentary in USA Today. The Research Action Plan, this is a manuscript
that we talk about the implementation of a National Trauma Research Action Plan, and I underlined research there, as I mentioned the vast majority of research dollars dedicated to topics in trauma and injury are from the DoD. This fills a really important national gap.
The NIH, although it addresses a breadth of important topics for the public and the nation, does not invest heavily in topics related to trauma and injury care and resuscitation. The DoD, in this paper, we outline that the DoD needs to develop these new product for battlefield.
This also compels our federal partners such as the FDA to acknowledge and accommodate the topics of trauma and injury. It helps the FDA and stimulates them to accommodate, for example, blood and blood products for trauma, new resuscitation devices that we'll talk
about this morning, et cetera. This is an example, the Stop the Bleed campaign, which is a great partnership with the Hartford Consensus, is a great example of translation of military experience to the civilian sector. The next two slides outline, and I'll refer you
to these publications on the recent change in the FDA and its accommodation of military relevant and trauma relevant products. This paper outlines the strengthening of the FDA and its clinical trial expertise, that relates to endpoints that are appropriate
for the study of injury and shock, blood and blood products, hemorrhage control, not just cardiovascular disease and infectious disease. There's a balance of pre and post-market data. There's new FDA guidance, a document that advocates for the use of real-world evidence,
which is also quite helpful. This is the website for the real-world evidence that the FDA has acknowledged is an important part of clearing and assessing trauma and injury products. And then there is a new public law and a new DoD, FDA MOU that really compels
and formalizes an accommodating approach by the FDA for products that are being developed by the DoD for wartime illness and injury. So these are all very new developments within Health and Human Services and the FDA, which I think are important underpinning
for the National Trauma Action Plan. So to conclude, the military plays a multifaceted role in this National Trauma Action Plan to increase homeland security and response to mass casualties. When it comes to effective military
and civilian care, as Don Berwick, senior author of the National Academy's report on national trauma care, said, we'll either succeed together or we'll fail together. Thank you very much.
patient female patient who has the sudden onset of upper abdominal pain here's the CT we did all these cases in one day it was crazy it was terrible so so here's a big hematoma a big peritoneal hematoma you
can see it anterior to the right kidney you can see the white blob of contrast right in the middle of the hematoma that's a pseudoaneurysm or even active extravagance um less experienced people would probably say it's active
extravagant I think most of us would prefer that it be called kind of a pseudoaneurysm this active extrapolation would be much more cloudy and spread out this is more constrained and you can see on the
coronal image you get a sense that there's that hematoma same type of problem all right is there more imaging that we can do to figure out the next step again I said earlier earlier in this lecture
that sometimes we use CTA now sometimes a CTA is worthwhile I do find that for a lot of these patients I think we're getting smarter and we're doing CTAs right at the beginning of this whole thing you know when a trauma
patient comes in we're getting CTAs so we can max out the amount of information that we get on the initial diagnostic imaging here's what we're seeing on the CTA and in this particular case I think it's pretty clear that you can see the
pseudoaneurysm arising from what looks like a branch of the superior mesenteric artery so this is just an odd visceral and Jake visceral aneurysm which looks like it probably ruptured I don't have an explanation for it led to a big
hematoma here's what that is and now we're gonna do an angiogram the neat thing is it just perfectly correlated with a conventional angiogram so here's our super mesenteric angiogram all right the supreme mesenteric artery
on the first image to the left is that vessel going downward towards the right side of the screen all those vessels coming off are really just collateral vessels going up to the liver through the gastroduodenal artery again that
left one looks pretty good it's not until you see the delayed image on the right that you see that area of contrast all right so that's the finding that correlates with the CT scan all right here we're able to get in there you put
a micro catheter in that vessel alright the key next step for this patient as I mentioned earlier is the whole concept of front door and back door so here we're technically in the front door the next thing that we do is we put the
catheter past the area of injury and now we embolize right across the injury because remember once you embolize one thing flow is gonna change we screw it up body the body wants to preserve its flow if we block flow
somewhere the body's gonna reroute blood to get to where we blocked it so we want to think ahead and we want to say okay we're blocking this vessel how's the body going to react and let's let's get in the way of that happening that's what
we did here so we saw the pathology we went past it we embolized all across the pathology and boom now we don't have anymore bleeding and the likelihood of recurrence is gonna be very low for that patient because we went all the way
across the abnormality and I think from
- I wanted to discuss this topic because some of us are more sensitive to DNA damage than others. And it's a complicated ethical issue. I have a disclosure in that I developed a formulation to premedicate patients prior to CT and x-ray. We all know that we stand in fields of radiation for most of our careers,
and we also know that many of us have no hair for example on the outside of our left leg. This is a picture that a bunch of us took for fun demonstrating this. But this is in fact radiation dermatitis. We know that the founders of our field
suffered consequences from the chronic high doses that they received in the 1920's. And they lost digits, they lost ears, they lost noses any many of them died of cancers or cardiovascular disease. The mechanism of injury is the x-rays
impinge upon water molecules in our cells. They create free radicals. These free radicals bind with our DNA and then Oxygen binds with that site resulting in an oxidative injury which can be reduced by the use of anti-oxidants.
I studied this over the last eight or nine years and I looked at the issue of chronic low dose radiation. Now this is different from the data that we collect from Nagasaki and Hiroshima and from Chernobyl and elsewhere. There are cancer risks but there
are also cardiovascular risks. And there are risks from chronic inflammation from increased reactive Oxygen species circulating with our system. I've been in touch with the IAEA recently about this and they didn't actually
realize that we don't wear our badges. So they thought the data they were getting on the doses that we were receiving were accurate. So that was a very interesting conversation with them. So cardiologists have been known
to get lifetime doses of of over one Gray. There's a lot of literature on this in public health literature. For example for every 10 milliSieverts of low dose ionizing radiation and received by patients with acute MI's,
there's a 3% increase in age and sex adjusted cancer risk in the follow-up five years. There's an excellent paper from Kings College London demonstrating that when endovascular surgeons were studied with two specific immunofluorescence tests, P53 and H2 alpha,
they were able to demonstrate that some endovascular surgeons are more sensitive to radiation dose than others. So why would that be? Well it's interesting if you look at this genetically and you look at the repair mechanisms
and in this whole thing I think in fact the lens is kind of the canary in the coal mine. When you get radiation induced cataracts, it's in the posterior chamber of the lens not the middle or anterior, which is where age-related injury occurs.
And this is the germinal layer or reproductive layer. The growth layer in the lens itself. And this is where cataracts develop. And this is really kind of a harbinger I think of injury that occurs elsewhere in our system. We know that when we wear DLDs on our chest,
on our bodies, on our arms, that the dose to the left side of our head is six times higher than to the right. In fact they dosed the left lens as higher than the right. And most of us who have lens replacements have it of the left eye.
This literature from adjacent fields that we may no be aware of. In the flight safety literature for pilots and stewardesses. There's extensive literature on cosmic radiation to flight crews who's doses annually are in the same range as ours.
So when you look at medical staff, you have to look at the overall context of the human in the Angio suite. Many of our medical staff will not be well. They may have chronic cardiac disease. They may be on say drugs for auto
immune disease or Methotrexate. They may have other illnesses such as Multiple Myeloma. They may have antibiotics on board that alter the DNA repair ability like Tetracycline. And they have chronic stress and sleep dysfunction. Cigarettes and alcohol use.
All of these things decrease their ability to repair DNA damage. If you look at DNA repair mechanisms, there are constantly the terms BRCA1 and two, PARP, P53, and ATM that show up. And deficiencies in these,
I'm going to skip all this to show you, can result in increased injury from a same dose being received by two different individuals. Now who is at risk from this is well understood in adjacent fields.
Here are 37 references from the public health literature related to mutations and SNPs or polymorphisms in DNA structure known to cause increased sensitivity to radiation. So I would propose that in, and here are papers on that topic
in adjacent fields that we don't read. So when we talk about personalized medicine for our patients, we need to also think about personalized career choices based on our DNA repair ability when we decide what we do. This has to be done in the context
of empathetic compassionate approach. It may begin with screening based on family history and personal history, and then advance in the right context to genetic screening through mutations and SNPs that can decrease their ability
to repair DNA damage from our occupational exposure. I'll skip all this because I'm out of time. But one other issue to think about, mitochondrial DNA is inherited purely maternally. So maternal DNA damage, mitochondrial DNA damage could be transmitted across generations
in female interventionalists. Also screening is important. It's emotionally complex. It's ethically complex. But it's an important conversation to begin to have. Thank you.
- The only disclosure is the device I'm about to talk to you about this morning, is investigation in the United States. What we can say about Arch Branch Technology is it is not novel or particularly new. Hundreds of these procedures have been performed worldwide, most of the experiences have been dominated by a cook device
and the Terumo-Aortic formerly known as Bolton Medical devices. There is mattering of other experience through Medtronic and Gore devices. As of July of 2018 over 340 device implants have been performed,
and this series has been dominated by the dual branch device but actually three branch constructions have been performed in 25 cases. For the Terumo-Aortic Arch Branch device the experience is slightly less but still significant over 160 device implants have been performed as of November of this year.
A small number of single branch and large majority of 150 cases of the double branch repairs and only two cases of the three branch repairs both of them, I will discuss today and I performed. The Aortic 3-branch Arch Devices is based on the relay MBS platform with two antegrade branches and
a third retrograde branch which is not illustrated here, pointing downwards towards descending thoracic Aorta. The first case is a 59 year old intensivist who presented to me in 2009 with uncomplicated type B aortic dissection. This was being medically managed until 2014 when he sustained a second dissection at this time.
An acute ruptured type A dissection and sustaining emergent repair with an ascending graft. Serial imaging shortly thereafter demonstrated a very rapid growth of the Distal arch to 5.7 cm. This is side by side comparison of the pre type A dissection and the post type A repair dissection.
What you can see is the enlargement of the distal arch and especially the complex septal anatomy that has transformed as initial type B dissection after the type A repair. So, under FDA Compassion Use provision, as well as other other regulatory conditions
that had to be met. A Terumo or formerly Bolton, Aortic 3-branch Arch Branch device was constructed and in December 2014 this was performed. As you can see in this illustration, the two antegrade branches and a third branch
pointing this way for the for the left subclavian artery. And this is the images, the pre-deployment, post-deployment, and the three branches being inserted. At the one month follow up you can see the three arch branches widely patent and complete thrombosis of the
proximal dissection. Approximately a year later he presented with some symptoms of mild claudication and significant left and right arm gradient. What we noted on the CT Angiogram was there was a kink in the participially
supported segment of the mid portion of this 3-branch graft. There was also progressive enlargement of the distal thoracoabdominal segment. Our plan was to perform the, to repair the proximal segment with a custom made cuff as well as repair the thoracoabdominal segment
with this cook CMD thoracoabdominal device. As a 4 year follow up he's working full time. He's arm pressures are symmetric. Serum creatinine is normal. Complete false lumen thrombosis. All arch branches patent.
The second case I'll go over really quickly. 68 year old man, again with acute type A dissection. 6.1 cm aortic arch. Initial plan was a left carotid-subclavian bypass with a TEVAR using a chimney technique. We changed that plan to employ a 3-branch branch repair.
Can you advance this? And you can see this photo. In this particular case because the pre-operative left carotid-subclavian bypass and the extension of the dissection in to the innominate artery we elected to...
utilize the two antegrade branches for the bi-lateral carotid branches and actually utilize the downgoing branch through the- for the right subclavian artery for later access to the thoracoabdominal aorta. On post op day one once again he presented with
an affective co arctation secondary to a kink within the previous surgical graft, sustaining a secondary intervention and a placement of a balloon expandable stent. Current status. On Unfortunately the result is not as fortunate
as the first case. In 15 months he presented with recurrent fevers, multi-focal CVAs from septic emboli. Essentially bacteria endocarditis and he was deemed inoperable and he died. So in conclusion.
Repair of complex arch pathologies is feasible with the 3-branch Relay arch branch device. Experience obviously is very limited. Proper patient selection important. And the third antegrade branch is useful for later thoracoabdominal access.
- I have no disclosures. - So the eye lens is a highly radiosensitive tissue. And the radiation damage is a cataract, this is a cancer-like pathology resulting from mutating events. It's a posterior sub-capsular cataract. And in several studies we have seen quite a large number of interventionalists or vascular surgeons or cardiologists
showing this exact type of posterior lens changes, characteristic of radiation exposure. About half of the interventionalists in this study. The risk increases with duration of work years and decreases with regular use of protection. So the conclusion in this paper was
that radiation injuries to the lens can be avoided. By, for example, reducing the dose. So this is obvious that we should do in every way we can do it. And there are many steps shown in this excellent paper published in the European Journal of Vascular Surgery.
And, on top of that, of course, use radiation shields. And I've been focused today on different eye shields. So we tested the eye dose reduction with several commercially-available protection glasses and shields during realistic endovascular procedures in an experimental setting,
using phantoms and dosimeters at the front of the eyes, the left and the right eyes. And this was an EVAR protocol using a Siemens C-arm. So we tested the more modern sports glasses. The reduction to the left eye was only 15 to 50 percent, or in some glasses just 10 to 15 percent.
So much, much lower than what's promised in the brochure. The fit over glasses protected best, especially if you don't use them over personal glasses. So this is because of the, it's if there is just a small gap between the cheek and the glasses, there's scattered radiation pulsing in there.
And it also scatters on your face up to the eye lens. We also tested visors and you can see the effect of having them at a correct angle. They should be downward-angled, and you have a pretty good protection. But the best of all was the ceiling-mounted shield,
if it's properly used with a very high reduction, 90 to 95 percent. So this is an image from our hospital. I'm in the middle with these fit-over glasses that we have all now beginning to use. So in this paper, it was nicely shown that the position
of the shield also is very important. So it should be very tight to the patient and close to the femoral access. Other protective measures like these surgical drapes, we use them and there is a good additive reduction of radiation exposure
to the chest and hands, shown by this paper. But no one has ever related the reduction to the head or the eye. And the latest addition in our center is this zero-gravity suit that has been shown to significantly reduce radiation exposure
to the whole body, including the head and the eyes. So I think this is a very important new device. In this study, from the London group, we can see that adherence to use these kinds of shields is depressingly low. Use of lead-protective glasses was only 36 percent
among the operators and ceiling-mounted leaded shields, no one uses them, at that time at least. So, in conclusion, there are several radiation protection eyeglasses used today. They offer a highly limited dose reduction, giving a false sense of security.
A proper use of ceiling mounted lead shields is essential for adequate protection to the eye lens. And the protection eyeglasses and visors should only be used as a complement. And consider also using additional devices as full-body protection to maximize your protection, thank you.
- I think that the most important tip cannot really be summarized in five minutes, which is that these procedures are highly dependent on how well you plan the procedure and how well you really implant the device. That is a fairly long learning curve that I think you need to actually collaborate with people
that they are experienced, and with industry to make sure that you are on the right track on making your measurements to size these devices. But there are a few things to be said about cases that are very difficult, and a few tips that I would highlight on this talk.
First, it's highly important that you build up your inventory so you can get out of trouble. I think you have to have a variety of catheters of your choice, with primary or secondary curves.
The addition of shapeable guides has been a major benefit for these types of procedures. They are fairly expensive, so I would say we don't use them routinely, but they can bail you out. They can allow you to do cases now from the femoral approach that in the past could not be achievable this way.
You have to be able to work on the diffe .035 system, .014 system, .018 system, and know when to apply this. I would like to highlight four maneuvers that we use when vessels don't align.
First, a common maneuver is really not to try to get in a quote/unquote pissing match with the fenestration and the vessel. If you can catheterize the fenestration first, and advance your sheath upwards, and lead a .018 wire into the sheath,
that will basically lock your sheath into the fenestration. Therefore, you don't have to repeatedly catheterize the fenestration and you save a lot of time. You can choose y ose something that has a secondary curve if you have room,
or a Venture 3 catheter, which is one of my choice for catheterization, and you can see here that on this case, the difficulties imposed by a shelf on the ostia of the renal artery, which makes catheterization more difficult. This .018 wire also allows you to bend your sheath
as a guide catheter so that you can achieve a downward curve to catheterize a down-going vessel, like on this renal artery. The second maneuver to highlight is that these devices are constrained posteriorly, and therefore, the fenestrations are naturally moved
posteriorly into the aorta. So one of the first maneuvers is really to try to move the fenestration more anteriorly by rotating the device. Now, some of the companies now have newer constraining mechanisms
that may alleviate some of this, but this is kind of a next maneuver that we do. Finally, rarely nowadays we have to really find more space between the fenestration and the aortic wall, but it is always useful to leave behind a wire when you deploy this device so that in the event
that you need more space, you can perhaps navigate the catheter, inflate, and create some space between the fabric and the aortic wall. Marcelo Ferreira, along with other collaborators, has described a technique that I think is very useful when you have a lot of space.
That's the case, for example, of a directional branch or perhaps if you are using fenestration to target a vessel that is somewhat away from the fabric of the endograft. That's called the snare ride technique. This is summarized on this illustration.
When you see the left renal artery to be up-going, now being targeted from the brachial approach, that was difficult to catheterize, you catheterize that from the femoral approach with an eight French sheath and a snare ride type... You snare the wire from the arm, and then you can
navigate that catheter inwards into the vessel. That can be difficult, sometimes, to actually advance the snare into the vessel. I think that there is some improvement on the profile of these snares that can improve that, but that is a very useful technique,
not only for branches, but also for fenestrations. Finally, sometimes you have too much space. You may seem you are very well aligned on the latitude with the vessel, but in fact, there is so much space the device got displaced on that sac and you cannot simply catheterize the vessel.
It's useful to downsize the system on these cases to a micro-catheter with a micro-wire to find yourself in the sac eventually out through the vessel. Once you achieve that, you would then exchange this micro-wire, usually a glide gold wire, to a .018,
a stiffer wire that is long enough. You advance a balloon that is undersized for that vessel, and with that you can straighten the system and eventually switch that for a wire that is of reasonable strength, such as a rosen wire in this case, and complete the case.
Finally, there is nothing wrong about leaving the battle to be fought another day. It's better to finish a case a little quicker and not end up with leg ischemia and a compartment syndrome and a s the situation
and come back another day. This is a case, for example, that I did a branch endograft. You can see the right renal artery is exceedingly narrowed. I could not find a way in in a reasonable time. I gave myself about half an hour. I decided to quit.
A few days later, I came back through a subcostal incision, got retrograde access, and this literally was a case that didn't take very long and end up doing very well. So in summary, patie select your proper
anticipat stent. To offset these challenges, minimize contrast a master your endovas
it is better to end with a patient alive and fight the battle another day, than to have an excessive long procedure leading to numerous other complications. Thank you very much.
- Doctor Dangas, congrats on really putting this all together and being the champion for this technique. 13 Centers, 517 patients in the original report. We've talked about this, the follow up and some of the limitations at 17 months, primary patency 94%, Gutter Endoleak 2.9%.
What about late outcomes? That's what everybody keeps wanting to know. We've put this series together so that hopefully by next year we'll be in the, some printed literature. Two and half years follow up,
a subset analysis of patients that have had that follow up. 244 patients, 387 snorkel/chimney grafts, nearly four years mean follow up in this cohort. Mean diameter, 64 milimeters. The neck diameter, 26. And the infrarenal neck length of 4.6.
Obviously then after the chimney strategy that increases as most of them generally have gone then above the, both renal arteries. 38% right renal. 46% left renal. A couple of accessory renals. A small number of SMA and Celiac snorkels in this group.
More than half of the Endurant Graft and the rest are of mix of Zenith, Excluder, Jotec, Talent that's no longer being used. And a couple of thoracic proximal pieces. About half Viabahn. 38% iCAST or Advant of E12. And a handful of Bare Metal very early in the series.
Half with one graft, more than a third with two, 10 percent with three and a small number with four. Pre-op Mean Sac Diameter from the entire 244 sub-cohort, 64 millimeters. The latest follow up with now four years Mean follow up 55, Mean Sac Regression per patient
in the 244 eight millimeters. This is an example of one of ours. Loss of Branch Patency. Look at the Kaplan-Meier number at risk even out to four years, 136 of the 368, not the typical Kaplan-Meier where out to four years
there's like five patients left, or five renals left. Out of 48 months, 92.5% patency. Univariate analysis, no predictors including the use of different types of chimney balloon-expandable versus self-expanding, total number of chimney grafts
did not seem to have an affect. Obviously, the problem with this technology or with this strategy has still been persistent or Late Type-1a Endoleaks and Gutter Endoleaks. We found in a couple of different series individual case series many of these do resolve
by the six or 12 month follow up. In this longer term cohort, now up from 3.7 is at 48 months Mean Follow Up time at 5.9% Gutter Endoleak, needing re-interventions in half of them. What are the risk factors for developing a persistent Gutter Endoleak?
A native neck diameter of greater than 30 and the absence of Infrarenal on univariate, and on multi-variate, only the native neck diameter greater than 30. Again, suggesting this theme that I think has been throughout the meeting of larger,
of needing more proximal fixation for things. Obviously, a lot of work going into trying to prevent or find optimal strategies for Gutter Type-1a Endoleaks. Mortality for the entire cohort now with the extended follow up at four years, 71%.
Costache already went over the optimal combinations of devices, which I think this contributed to the approval CE mark, at least of the enduring graft with a balloon-expandable chimney for that. Interestingly and what, you know, I think many of us have been proposing,
one to two is obviously better than three or four, and I don't think that aligning it is necessary. So in summary, compared to meta-analysis of real world data for fenestrated, which I understand in the room there are obviously single center experts
that have better numbers than what's out there listed in the literature in terms of number of grafts, mortality Type-1a Endoleak, branch patency and need for 2nd intervention similar between these strategies. Thanks for your time.
- Thanks, Stefan and Frank for having me back again this year. These are my disclosures as it pertains to the renal topics here. We all know that renal dysfunction severely impacts survival, whether we're doing open or endovascular aortic repair,
as you see by these publications over the past decade, patients with no dysfunction have a significant advantage in the long term, compared to those patients who suffer acute kidney injury, or go on to be on new hemodialysis. When you look at the literature,
traditionally, through open repair, we see that the post-operative rate of acute kidney injury ranges anywhere from 20 to almost 40 percent, and it doesn't seem to vary whether it's a suprarenal or infrarenal type
of clamp or repair. Chronic renal replacement therapy in this population ranges somewhere between 0 and 3 percent. That really forms a baseline when we want to compare this to the newer techniques such as chimney and fenestrated or branched EVAR.
Now, if you look at the results of the ZFEN versus Zenith AAA trials, and this is published by Gustavo, the acute kidney injury rate is approximately at 25%, acute kidney injury rate being defined as patients, excuse me, greater than 25% change in GFR,
but in one month acute kidney injury rate is 5% for FEVAR and about 9% for EVAR in this study. There's no difference in these rates at two years or five years between the Zenith AAA and the ZFEN devices. What about the progression of patients
with Stage 4 or Stage 5? At two years, it's about the same, 2% versus 3% for EVAR, and at five years, 7 and 8% respectively. Overall, progression to renal failure occurs in about 1.5% of patients in this cohort.
Well, how does that compare to chimney cases, if you look at the Pythagoras and PERICLES studies, there are a limited number of patients, you see in Pythagoras, 128 patients, 92% of them had either one or two chimneys, meaning generally addressing renal arteries in this case,
patency of those grafts was about 96% and there is no real discussion in that manuscript of the degree of acute kidney injury. And in PERICLES registry, however, they report a 17.5% incidence of acute kidney injury post-op,
and a 1.5% incidence of temporary or permanent dialysis. What about if you compare them? This is a publication in 2017, if you look at both of these studies, very similar, 17.8% for acute kidney injury in FEVAR, and about 19% for a chimney.
You have to realize, though, there are more complete repairs in the FEVAR group, and there are more symptomatic patients in the ChEVAR group, so these aren't completely comparable, but you get some idea that they're probably in the general range of one another.
So the real questions, I think, that come up, is, which arteries can you sacrifice? Are renal embolizations impacting patients' overall function? And what is the mid-term impact of branch and fenestrate on volume of your kidneys
and patients' eGFR. We've studie we looked at the incidence and clinical significance of renal infarcts, whether we actually embolized these pre-procedure,
or whether we accidentally covered or intentionally covered an accessory renal artery, what was the outcome of those patients? We see over time, the average renal volume loss, calculated by a CT scan and VAT volume, is about 2.5% if you embolize it
and if you just cover an accessory renal, about 6.4%. But overall, about 4%, didn't change significantly, overall the GFR changed over the lifespan of the first two years of the patient of 0.1, so it wasn't a significant clinical impact on the patient's overall renal function.
Now what about looking at it specifically of what happens when you do branch and fenestrate cases with respect to eGFR and volume of those? We presented this at this past year's SABS, and it is in submission. If you look at the changes of eGFR,
you notice that in the first six months, the patient declines, but not significantly, and then you see in the graph there, it tends to come back up by a year, year and a half. Very similar to what Roy Greenberg published in his initial studies,
but what we did in this study was actually compare it to the age match publications, and you see that eGFR over time was similar to what happens in age-related changes, but we also noticed that 16% of the patients, 9 of 56, had improvement of their eGFR
to greater than 60. Now whether this is just related to the inaccuracy of the eGFR and its variance, or whether we actually improved some renal stenosis, is difficult to tell in this small study. In conclusion, open, fenestrated,
and chimney EVAR procedures are associated with acute kidney injury in approximately 20% of patients. Causes of deterioration are likely multifactorial and may be different for each technique used. Renal infarcts from covering accessory renal arteries
and embolization occur in about a quarter of the patients, and is a small contributor to renal decline over time. Renal decline made after FEVAR is similar to associated with age. Thank you.
my last case here you have a 54 year old patient recent case who had head and neck cancer who presents with severe bleeding from a tracheostomy alright for some bizarre reason we had two of these
in like a week all right kind of crazy so here's the CT scan you can see the asymmetry of the soft tissue this is a patient who had had a neck cancer was irradiated and hopefully what you can notice on the
right side of the screen is the the large white circles of contrast which really don't belong there they were considered to be pseudo aneurysms arising from the carotid artery all right that's evidence of a bleed he was
bleeding out of his tracheostomy site so here's a CTA I think the better image is the image on the right side of the screen the sagittal image and you can see the carotid artery coming up from the bottom and you can see that round
circle coming off of the carotid artery you guys see that so here's the angiogram all that stuff that is to the right to the you know kind of posterior to the right of the screen there it doesn't belong there that's just
contrast that's exiting the carotid artery this is a carotid blowout we'll call it okay just that word sounds bad all right so that's bad so another question right what do you want to do here
I think embolization is reasonable but probably not the thing we can do the fastest to present a patient to treat a patient is bleeding out of the tracheostomy site so in this particular case this is a great covered stent case
alright and here's what it looked like after so we can go right up and just literally a cover sent right across the origin of that pseudoaneurysm and address the patient's bleeding alright
- I have no disclosures. So I'm going to show you some pictures. Which of the following patients has median arcuate ligament syndrome? A, B, C, D, or E? Obviously the answer is none of these people.
They have compression of their celiac axis, none of them had any symptoms. And these are found, incidentally, on a substantial fraction of CT scans. So just for terminology, you could call it celiac compression
if it's an anatomic finding. You really should reserve median arcuate ligament syndrome for patients who have a symptom complex, which ideally would be post-prandial pain with some weight loss. But that's only I think a fraction of these patients.
Because most of them have sort of non-specific symptoms. So I'm going to say five things. One, compression of the celiac artery is irrelevant in most patients. It's been found in up to 1/3 of autopsies, MRIs, diagnostic angiography, CT.
This is probably about par, somewhere in that 5% or 10% of CT scans that are in asymptomatic patients will have some compression of the celiac axis. The symptoms associated with median arcuate ligament syndrome are non-specific,
and are really not going to tell you whether patients have the disease or not. So for instance, if you look here's like 400 CT scans, 19 of these patients had celiac compression. But the symptom complex in patients
who had abdominal pain for other reasons looked exactly the same as it did for people who had celiac compression. So symptoms isn't going to pull this apart. So you wind up with this kind of weird melange of neurogenic, vascular,
and you got to add a little psychogenic component. Because if any of you have taken care of these people, know that there's a supertentorial override that's pretty dramatic, I think, in some fraction of these people. So if you're not dizzy yet, the third thing I would say,
symptom relief is not predicted by the severity of post-operative celiac stenosis. And that's a little distressing for us as vascular surgeons, because we think this must be a vascular disease, it's a stenotic vessel. But it really hasn't turned out that way, I don't think.
There's several papers, Patel has one just in JVS this month. Had about a 66% success rate, and the success did not correlate with post-op celiac stenosis. And here's a bigger one,
again in Annals of Vascular Surgery a couple years ago. And they looked at pre- and post-op inspiratory and expiratory duplex ultrasound. And basically most patients got better, they had an 85% success rate. But they had patients,
six of seven who had persistent stenosis, and five of 39 who didn't have any symptoms despite improved celiac flow. So just look at this picture. So this is a bunch of patients before operation and after operation,
it's their celiac velocity. And you can see on average, their velocity went down after you release the celiac, the median arcuate ligament. But now here's six, seven patients here who really were worse
if you looked at celiac velocity post-op, and yet all these people had clinical improvement. So this is just one of these head scratchers in my mind. And it suggests that this is not fundamentally a vascular problem in most patients. It goes without saying that stents are not effective
in the presence of an intact median arcuate ligament. Balloon expandable stents tend to crush, self-expanding stents are prone to fracture. This was actually published, and I don't know if anybody in the audience will take credit for this.
This was just published in October in Vascular Disease Management. It was an ISET online magazine. And this was published as a success after a stent was put in. And you can see the crushed stent
because the patient was asymptomatic down the road. I'm not discouraging people from doing this, I'm just saying I think it's probably not a great anatomic solution. The fifth thing I'd say is that comorbid psychiatric diagnoses are relatively common
in patients with suspected median arcuate ligament syndrome. Chris Skelly over in Chicago, they've done an amazing job of doing a very elaborate psych testing on everybody. And I'll just say that a substantial fraction of these patients have some problems.
So how do you select patients? Well if you had a really classic history, and this is what Linda Riley found 30 years ago in San Francisco. If they had classic post-prandial pain with real weight loss and a little bit older patient group,
those people were the easiest and most likely to have a circulatory problem and get better. There are some provocative tests you can do. And we did a test a few years ago where we put a catheter in the SMA and shoot a vasodilator down,
like papaverine and nitroglycerin. And I've had patients who spontaneously just said, "That's the symptoms I've been having." And a light bulb went off in our head and we thought, well maybe this is actually a way you're stealing from the gastroduodenal collaterals.
And this is inducing gastric ischemia. I think it's still not a bad test to use. An alternative is gastric exercise tonometry, which is just incredibly elaborate. You got to sit on a bicycle, put an NG tube down to measure mucosal pH,
get an A-line in your wrist to check systemic pH, and then ride on a bike for 30 minutes. There's not many people that will actually do this. But it does detect mucosal ischemia. So for the group who has true circulatory deficiency, then this is sort of a way to pick those people up.
If you think it's fundamentally neurogenic, a celiac plexus block may be a good option. Try it and see if they react, if maybe it helps. And the other is to consider a neurologic, I mean psychologic testing. There's one of Tony Sadawa's partners
over at the VA in Washington, has put together a predictive model that uses the velocity in the celiac artery and the patient's age as a kind of predictive factor. And I'll let you look it up in JVS. Oddly enough,
it sort of argues again that this is not a circulatory problem, in that the severity of stenosis is sort of inversely correlated with the likelihood of success. So basically what I do is try to take a history,
look at the CTA, do inspiratory and expiratory duplex scans looking for high velocities. Consider angiography with a vasodilator down the SMA. If you're going to do something, refer it to a laparoscopist. And not all laparoscopists are equal.
That is, when you re-op these people after laparoscopic release, you often times find a lot of residual ligament. And then check post-operative duplex scans, and if they still have persistent symptoms and a high-grade stenosis,
then I would do something endovascular. Thank you.
- Thank you Dr. Melissano for the kind interaction. TEVAR is the first option, or first line therapy for many pathologies of the thoracic aorta. But, it is not free from complications and two possible complications of the arch are the droop effect and the bird-beak. I was very interested as Gore came up with the new
Active Control System of the graft. The main features of this graft, of this deployment system are that the deployment is staged and controlled in putting in the graft at the intermediate diameter and then to the full diameter. The second important feature is that we can
optionally modify the angulation of the graft once the graft is in place. Was very, very interesting. This short video shows how it works. You see the graft at the intermediate diameter, we can modify the angulation also during this stage
but it's not really used, and then the expansion of the graft at the full diameter and the modification of the angulation, if we wished. This was one of the first cases done at our institution. A patient with an aneurysm after Type B dissection. You see the graft in place and you see the graft after
partial deployment and full deployment. Perhaps you can appreciate, also, a gap between the graft and the lesser curvature of the arch, which could be corrected with the angulation. As you can see here, at the completion angiography we have an ideal positioning of the graft inside the arch.
Our experience consisted only on 43 cases done during the last months. Mostly thoracic aneurysm, torn abdominal aneurysm, and patients with Type B aortic dissection. The results were impressive. No mortality, technical success, 100%,
but we had four cases with problems at the access probably due to the large bore delivery system as you can see here. No conversion, so far and no neurological injury in this patient group. We have some patients who came up for the six months follow-up and you see here we detected one Type 1b endoleak,
corrected immediately with a new graft. Type II endoleak which should be observed. This was our experience, but Gore has organized all the registry, the Surpass Registry, which is a prospective, single-arm, post market registry including 125 patients and all these patients
have been already included in these 20 centers in seven different countries in Europe. This was the pathology included, very thorough and generous, and also the landing zone was very different, including zone two down to zone five. The mean device used per patient were 1.3.
In conclusion, ladies and gentlemen, the Active Control System of the well known CTAG is a really unique system to achieve an ideal positioning of the graft. We don't need to reduce the blood pressure aggressively during the deployment because of the intermediate diameter
reached and the graft angulation can be adjusted in the arch. But, it's not reversible. Thank you very much for your attention.
- Thank you, and thank you to Dr. Veith for his kind invitation. These are my disclosures. Basically, we took a single center two-year outcomes for the use of fenestrated grafts and compared to parallel grafts in treating patients with complex aortic aneurysms.
These included fenestrated grafts and parallel grafts for juxtarenal, suprarenal, and thoracoabominal aneurysms. And the usual risk factors, morbidity, mortality, patency, and re-intervention rates were evaluated. This is a retrospective review of a prospectively maintained database.
All consecutive patients were included with exception of those presenting with rupture. Symptomatic patients were included. The type of repair was the single surgeon decision based on urgency and the patient's anatomy. And the parameters, as we discussed, were measured.
The fenestrated technique is fairly well-described and as we found the standard the technique of using fenestrated grafts. We have a Zeego hybrid suit Siemens that we used for all our implants. Most of these patients were done are local anesthesia
with percutaneous access. iCast or VBX stents were used for the bridging stents. An SMA was selectively self-extended with a self expanding stent in the Zfen cases alone. We look at the parallel graft. We had some bias in that we put no more than
two parallel grafts at any one level such as you see here. We came in and put a stent and then cautherize the celiac and the SMA, deployed the stents here. Then put a bridging RA thoracic endograft and then came in with a second endograft down to the level of the renals and the second set.
This is to decrease the instance of gutter leaks and need for reintervention. This analysis was formed with Kaplan-Meier and with p value of 0.05 being considered significant. Results. Basically, we had a 117 complex aneurysms
that were performed with a 100% technical success rate. We didn't look to the patients with significant branch special involvement, not just an isolated vessel. And we see in the parallel grafts, we had good distribution between renal, SMA, and celiac.
Obviously with a fenestrated graft, we had a stronger bias to the celiac not being involved in the SMA and renals being more commonly involved. Demographics are similar between the two groups. And the comorbidities were similar with the highest is hypertension and tobacco use.
The mortality was not statistically different with about a 3% to 2.6% perioperative mortality. Again that's one patient in each group. We had reinterventions. It was higher in the parallel graft group and that was later in the series at 7% compared to 5.3%.
Again not statistically significant. The reinterventions were similar for the fenestrated group. We had two renal stent occlusions, one colonic ischemia, one iliac limb occlusion, requiring reintervention, and one perinephric hematoma from a wire perforation.
And then in the parallel group, we had three endoleaks, two renal graft thrombosis, one celiac thrombosis, one renal stent kink, and one gutter leak. So again, using those two parallel grafts only at one level tended dramatically decreased our instance of gutter leak
compared to the reported literature. Freedom from aortic mortality. They were not different. We had 97% freedom from aortic mortality in those patients with fenestrated, 94% in those patients with parallel grafts.
Overall survival again was the same at 78% going out to two and a half years in both groups. Reintervention we saw again as we mentioned in the fenestrated graft once they plateaued around 12 months they seemed to fairly stable. But those going with the parallel graft,
we did see further late need for reintervention. So in conclusion, I think certainly in this retrospective review of parallel and fenestrated grafts, they have an acceptable perioperative mortality noted for juxtarenal, suprarenal, and thoracoabdominal aneurysms.
Parallel graft and technology has acceptable patencies with a low rate of reintervention and very low rate of gutter leaks in this series. The snorkel-sandwich technique is a very viable option especially when four vessels are involved or a sense of urgency when you don't have time
to get a fenestrated graft if it's available in your institution. And we certainly if we have a type two or three thoracoabdominal in parallel grafts we tended to stage those to decrease the paraplegia rate. Thank you very much for your attention.
- Thank you very much, Frank, for the opportunity to be part of this fantastic panel. So, I'm no more a part of the debate, and I will not show the differences, but if we look on the arch, on the literature addressing the different types of repair, we can see that the result are in the same range, approximately.
And despite the fact that we didn't spoke about this, probably, there is a bias of selection where else the best patient will be addressed by open surgery, patient that fits for branched and FEVAR will be treated by those technology, and the remaining of the patient
is addressed by parallel grafts. There is a second point I would like to address and this is one part of my talk, is that the results for the endovascular options are not good, are not so long described in the literature. There are some papers with longer follow-up,
but in the mean, the follow-ups are rather short. So, let's go to our expanse that is a little bit longer. In the arch, we treated 94 patients. We had a mortality of 14% stroke, or neurological complication 8%, endoleak, primary, 18%, but we addressed 40% of acute patients,
and 50 patient with redo thoracic surgery. So, an example: 75 years old patient, he had complicated type B dissection with malperfusion, did get the TEVAR with a sandwich for the LSA. In the follow-up, he showed an aortic enlargement with the dissection extending proximal to the LSA,
and he had, again, and antegrade perfusion of the sur-lumen. He refused general anesthesia because he had severe delire when he was treated first. So we address this with periaortic grafts. We put one chimney for the brachiocephalic trunk in the aorta, one chimney for
the left carotid artery in the ascending aorta, then we deployed a TAG in the aorta then, to match the diameter of the BCT we extended the first viable, which is 13 mm, and you can see here, the six month follow-up with a nice result. So, if we want to go to long-term results,
we freezed a cohort of patient we treated 2009 to 2014. These are 41 patients with an Euroscore II of 28%, 68 years the mean age, 30 day mortality was 12%, so half of the predicted. You see here 42 months follow-up of this cohort. There is this typical mortality of 10% a year
following the procedure, due to the comorbidity cardiac pulmonary renal functions, freedom of branch occlusion is nice and the branch behaved stable. There have been reintervention during the follow-up, mainly to treat endoleaks, branch issues,
or other problems on this patient, but you see there is a three and a half year follow-up and the rate of reintervention is the same than for other endovascular options. Looking now at the more complex patients, the free vessel in the arch, you see
that the results here are good too, for the parallel grafts. Here down, we see one patient dying, no stroke, no endoleak. If we go to the visceral patient, here the literature review shows a mortality of 4.7%, with an endoleak type 1A of 7% for the parallel grafts. If we do compare now CHIMPS with FEVAR and open repair,
you can see that maybe the difference is more redo, but it's not really much more than for the FEVAR/BEVAR, and here is particularly due to the gutters. We treated here also for the long-term follow-up, we freezed a cohort of patient, 127 patient, 40% symptomatic, 11% ruptured patient.
Hostile chest, 37%, hostile abdomen, 26%. Most of the proximal landing was above the renal artery, mostly chimneys, but also reversed grafts and sandwich. Here a case, patient that was rejected after rupture from two centers to one because he was unfit for surgery, the other because he qualified not for FEVAR/BEVAR.
He had a challenging anatomy with an occluded left renal artery and celiac trunk, a shaggy arch and LSA, so we treated him transfemorally with two parallel grafts and you see the outcome of this patient. So, there are reinterventions. The mortality in this cohort is 2.4%, endoleak is 7%.
Reintervention, chimney-related, mainly gutter endoleaks. These are the curves in the follow-up, and you see that the results are similar than the patient in the arch with a need for reintervention, but that's the same for any kind of endovascular procedure in the arch.
18% at three years of reintervention. This has been for branch thrombosis or endoleak cages. So, in conclusion, the results are good for parallel grafts in the arch and in the visceral types, and selected patient, they need an appropriate anatomy, a life expectancy of two years.
They behave durable up to more than three years mean follow-up, taking into account the number of reintervention. The unsolved issue with the parallel graft is the gutter, so this technique can improve, and you can see here that they may be solution for the future.
This is an anti-gutter design from Endospan that really eliminates any kind of gutter endoleak and wandering, and this will be the patient cohort that we will compare with other repair technique in the future. Thank you very much for your attention.
- Thank you. Thank you again for the invitation, and also my talk concerns the use of new Terumo Aortic stent graft for the arch. And it's the experience of three different countries in Europe. There's no disclosure for this topic.
Just to remind what we have seen, that there is some complication after surgery, with mortality and the stroke rate relatively high. So we try to find some solution. We have seen that we have different options, it could be debranching, but also
we know that there are some complications with this technique, with the type A aortic dissection by retrograde way. And also there's a way popular now, frozen elephant trunk. And you can see on the slide the principle.
But all the patients are not fit for this type of surgery. So different techniques have been developed for endovascular options. And we have seen before the principle of Terumo arch branch endograft.
One of the main advantages is a large window to put the branches in the different carotid and brachiocephalic trunk. And one of the benefit is small, so off-the-shelf technique, with one size for the branch and different size
for the different carotids. This is a more recent experience, it's concerning 15 patients. And you can see the right column that it is. All the patients was considered unfit for conventional surgery.
If we look about more into these for indication, we can see four cases was for zone one, seven cases for zone two, and also four cases for zone three. You can see that the diameter of the ascending aorta, the min is 38,
and for the innominate artery was 15, and then for left carotid was eight. This is one example of what we can obtain with this type of handling of the arch with a complete exclusion of the lesion, and we exclude the left sonography by plyf.
This is another, more complex lesion. It's actually a dissection and the placement of a stent graft in this area. So what are the outcomes of patients? We don't have mortality, one case of hospital mortality.
We don't have any, sorry, we have one stroke, and we can see the different deaths during the follow-up. If we look about the endoleaks, we have one case of type three endoleak started by endovascular technique,
and we have late endoleaks with type one endoleaks. In this situation, it could be very difficult to treat the patient. This is the example of what we can observe at six months with no endoleak and with complete exclusion of the lesion.
But we have seen at one year with some proximal type one endoleak. In this situation, it could be very difficult to exclude this lesion. We cannot propose this for this patient for conventional surgery, so we tried
to find some option. First of all, we tried to fix the other prosthesis to the aortic wall by adjusted technique with a screw, and we can see the fixation of the graft. And later, we go through the,
an arrangement inside the sac, and we put a lot of colors inside so we can see the final results with complete exclusion. So to conclude, I think that this technique is very useful and we can have good success with this option, and there's a very low
rate of disabling stroke and endoleaks. But, of course, we need more information, more data. Thank you very much for your attention.
- Thank you very much. Thank you, Frank, for inviting me again. No disclosures. We all know Onyx and the way it comes, in two formulas. We want to talk about presenter results when combining Onyx with chimney grafts. The role of liquid embolization or Onyx is listed here.
It can be used for type I endoleaks, type II endoleaks and more recently for treatment of prophylaxis of gutters. So what are we doing when we do have gutters? Which is not quite unusual. We can perform a watchful waiting policy, pro-active treatment in high flow gutters,
pro-active treatment low flow gutters, or we can try to have a maximum overlap, for instance with ViaBahn grafts 15 centimeters in length or we can use sandwich grafts in order to reduce these gutters in type I endoleaks. Here, a typical example of a type I leak treated with Onyx.
And here we have an example of a ruptured aneurysim treated with a chimney graft. And here is what everybody means when they're talking about gutters. Typical examples, this is what you get. You can try to coil these
or you can try to use liquid embolization. Here's the end result after putting a lot of coils into these spaces. What are these issues of the chimney-technique type I endoleak? Which are not quite infrequent as you see here.
Most of these resolve, but not all of them. So can we risk to wait until they resolve? And my bias opinion is probably not. Here, the incidents of these type endoleaks is still pretty high. And when you go up to the Arch
the results can even be different. And in our own series published here, type I endoleak at the Arch were as high as 28%. A lot of these don't resolve over time simply because it's a very high flow environment. Using a sandwich technique is one solution
which helps in a lot of cases but not all of these simply because you have a longer outlet compared to a straightforward chimney graft. You can't rely on it. So watchful waiting? There are some advocates who
prefer watchful waiting but in high flow gutters this is certainly not indicated. And the more chimneys you have, like in a thoracoabdominal aneurysm with four chimneys, the less you can wait. You have to treat these very actively,
like you see here, in these high flow areas. Here a typical example, again symptomatic aneurysm with sealing. Here Onyx was used but without any success. So what we did is we had to add another chimney and plus polymer sealing and then we had a good result.
Here some results, only small serious primary gutter sealing using Onyx with good results in a type I leak. But again, this is only a small series of patients. Sandwich technique already mentioned. When you use, like we did here for chimney grafts in the arteries, you do need Onyx otherwise you
always get problems with these gutters and they do not seal over time. Another example where liquid polymer was used. And here again, you see the polymer. The catheter in order to inject the polymer is very difficult to see but with a little bit of experience
you know where you are. And again, here it is, the Onyx, a typical example. Here another example of the Arch, bird beacon effect, extension, chimney graft. Again the aneurysm gets bigger. And so a combination of using proximal extensions
plus chimneys plus liquid embolization solves this problem after quite a long period of time. And here typically is what you see when you inject the Onyx. This does not work in all cases. Here we used Onyx in order to seal up the origin of the end tunnel.
This works very nicely but there is so ample space for improvement and in some cases it's probably better to use a fenestrated branch graft or even the opt two stabler instead of using liquid embolization. Thank you very much.
- [Jes] Here are my potential disclosures, I have none. Research in non-aneurysm screening programs points to the risk of more or less severe negative, psychological side effects. It is feelings of stigmatization, fear, aggression, psychosomatic reactions, social isolation, nocebo effects, that's the completely opposite than placebo.
It causes illness and blame the victim reactions in lifestyle mediated diseases. And I ... Expose the psychological side effects, also in my first screening trial, and concluded that the offer of screening
causes transient psychological stress in subjects, found to have no aneurysm. But more seriously, diagnosis of an aneurysm seems to impair quality of life progressively, in conservatively treated cases. And this impairment
seems completely reversible by operation. And that is just what the UK SAT Trial also reported. But it couldn't confirmed in the MASS trial by Theresa Marteau. She is one of the leading experts in psychometrics.
And she is exceptionally critical on screening. She couldn't show any significant reaction or states compared to the non-invited controls, except a short and transient reaction on those having surgery. In all the differences if any were small, she concluded.
Neither could I in my second randomized trial, but this time I was aware of the side effects, and carefully instructed on how to inform the screened positive men. The MASS trial was also the second trial of Mr. Alan Scott. He was experienced from the Chichester trial,
and may have done the same experiences. And qualitative studies in recently initiated programs also conclude the need for proper information. So I'll tell you one message today, is let the patients know, "The danger of an aneurysm is not knowing you have one."
As underset, we can calculate that it takes approximately two elective repairs to prevent one rupture. It may sound quite acceptable, but you can also formulate it this way, that approximately half of those referred for elective repair,
they risk complications and death for conditions that they never would have trouble with if it was left unrepaired. This is a serious and an ethical dilemma which can't be solved currently. Not for screen detected cases,
not for randomly detected cases. We simply need better tools. Nevertheless, screening and preventive repairs still saves more lives and it doesn't cause more postoperative death, and complications because it prevents emergency procedures.
And the fact that treating screen detected cases are much less dangerous than treating incidentally detected cases. Screen detected cases actually are treated with one third the risk of those detected incidentally. So when the randomized clinical trials,
are weighted in a population based view, using gained, quality adjusted living years and its costs, early detection shows to be efficient and cost effective, but it doesn't take into account other psychological costs. Diagnoses without benefit and harm against people who would never have problems if they were left alone.
But who is to decide what's best for the individual? I know a lot of ... people who want to play God and take the decision on other people, but I strongly believe that men age 65 are old enough to make a decision on their own.
Thank you very much.
- I want to talk on managing branch complications. This is my disclosure. We overlook in the Berlin-Brandenburg Helios Vascular Center about 466 patients treated with branched, TVAR and fenestrated EVAR devices. All patients received Zenith stent-grafts, custom made devices, T-Branch, or standard fenestrations
in all cases. The target arteries that we are talking about were renal, SMA, celiac access and internal iliac arteries. We used exclusively bridging stent-grafts that were balloon expandable stent-grafts. This is the differentiation of the patients
so we had EVAR fenestrated grafts in 190, branched TVAR in 138 patients, 93 of them were off the shelf devices and T-branch. EVAR with iliac side branches in 138 patients and all together we treated target arteries of 1270. You see the hospital mortality of these procedures
you can see a clear difference between the EVAR fenestrated graft and the branched T version are much more complex procedure and although overall mortality was 4.9% over these 13 years. What happened in these patients we experienced
in 44 patients, 44 complications in the target arteries so unfortunately one target artery problem per patient in these complicated cases. This means rate of 3.5% problems in the target arteries overall. Involved were renal arteries in 32 cases,
SMA in 10 cases and the celiac artery in two cases. What did we do in these cases? Managed the complications once thrombolysis was different devices for example were Rotorex stenting of the dissected vessels, coiling if unavoidable or occlusion of the side branch if no access was possible.
Show you some examples. This is a very serious complication where we were unable to enter the SMA resulting in occlusion of you see on the right slide that this was solved by laparotomy and retrograde access to the SMA.
This is a stenting of a dissected renal artery which could be managed quite nicely with an extension of the stent. Here we have again a prolonged intraprocedural SMA occlusion. We finally managed to enter the vessel
but it was very, very long and prolonged time. This is an inaccessible celiac artery where we have finally had to skip, not iliac sorry, celiac artery where we had to skip the implantation finally and occlude the branch with Amplatzer plug.
All together if you look at these complications in 34 cases we were successful in clinical point of view. In 9 patients complication was little and majority of these were complications involving the SMA. Eight of nine patients had with severe complication in the SMA and died
and so the SMA complications contribute, compared to the mortality, 40% to the procedural mortality in these branched cases. So in conclusion, injury to target artery in endovascular repair with branched and fenestrated stent-grafts are rare
but may be a serious complication especially damage to the SMA has a high mortality and thus further improvement of endovascular skills, instruments for example moveable sheaths which we had not available in the beginning and troubleshooting devices are mandatory
to avoid these complications. Thank you very much for your attention.
- And I'll think I'll take just the next presentation or few minutes to describe the military's experience with and some of the rational and processes by which the military has developed this concept of resuscitative endovascular balloon occlusion of the aorta.
And maybe give some examples of how this is now being implemented into the military's more forward practice of causality care down range. So I have no relative disclosures to make as it pertains to this topic.
But I would say for context and I think we often overlook this, is this is really the first war, prolonged period of war, combat operation which was been concurrent with an endovascular revolution. We really describe this, the beginning of implementation of endovascular techniques
downrange in Iraq in the early 2000s. In this manuscript in the Journal of Trauma. And if you think about it as well, this is the first prolonged period of combat in which we have had endovascular trained surgeons So, many of the technologies and then the skill set
just didn't exist in previous long periods of conflict. During the Vietnam war or prior to that. So this is a major impetuous behind this. Both for research and innovation and application of skills that you've heard today. Whether it's stent grafts, coil embolization plugs
or other endovascular approaches. So this war experience coupled with the explosion of endo technologies in the civilian settings for age related disease has really lead the DoD now from our perspective to explore these new approaches and technologies including REBOA.
So it was an initiative path for us to look for control of noncompressible torso hemorrhage. We appraised and redefined balloon occlusion of the aorta as Tao and others have said, this isn't necessarily a new concept, but we did frame it in the concept of hemorrhagic shock and from trauma and injury
from the military standpoint in this 2011 Journal of Trauma procedures and techniques paper we really defined it as a strategy the military wanted to explore for torso hemorrhage and in this paper defined these zones of occlusion in a setting of trauma and hemorrhagenic shock.
We needed of course new and emergency amenable technology a lot of the existing endovascular technology is designed to be used in endovascular suites by highly skilled endovascular specialist and that's great when available, but certainly from our standpoint, we wanted
technology change to make this more amenable for forward situations. We described this in this Journal of Trauma manuscript and sort of show and depict the new technologies, trying initially to downside the catheter, make the balloon
inclusion catheter smaller, perhaps make them not dependent upon fluoroscopy and make them put the nitinol wire inside the catheter so that it does not need an accompany over the wire long over the wire for insertion. So this is a design in this case
for a one pass quick insertion of a ER-REBOA catheter shown or depicted here. We also had markers on the catheter which is fairly simple, but really remarkably was not present on any of our catheters to tell the depth of insertion
because they were all dependent up on fluoroscopies so these are some examples of new technologies that the military has pushed in this area of endovascular balloon inclusion. This has resulted in a commercialized device. The ER-REBOA catheter as one example by PryTime Medical.
This catheter is now been approved in a dozen or more countries world wide. And it has now more than 5,000 patient uses. For Hemorrhagic shock and in the emergency setting. It's now being used by US and other militaries in austere or forward settings
under protocol and under clinical practice guidelines that I'll mention in the next slide. So this technology and making balloon occlusion more amenable for the emergency use setting for hemorrhagic shock has evolved to this point. This is an example of what we would refer
to as rapid-cycle research development translation within a five or six year period, we now have this new device into our clinical practice guideline, this is public domain you can Google JTS CPGs for REBOA and you'll see here
this is actually the second clinical practice guideline the military has done rapid cycle evolution of its CPGs for REBOA and this is as described in the CPG as a resuscitative adjunct to blood resuscitation and other maneuvers, that Tao nicely described. We do have this deployed and it is
under CPG sort of guidance This is an example of a publication from just this last summer on the use of REBOA as a resuscitative adjunct by our special operations surgical teams or SOST teams, you see a typical operating room
or maybe it's at least one example of a far forward operating room. In which the special operation surgical teams are using not only low titer, type O whole blood transfusion as part of damage control resuscitation and damage control surgery, DCS and DCR.
But also REBOA, they've implemented now the use of these balloon catheters as an adjunct in more than 20 cases down range. We have now clinical registry data coming back from the use of this device. As a resuscitative adjunct, mostly as a perioperative
to enter hemoperitoneum in a patient that's shocked when you're in an austere setting without a lot of blood or surgical assistance. So it is being used now down range and that use is described in this reference. It's been described, REBOA's been
described by the Royal Navy. Actually in this Royal Army Medical Core journal paper from 2018. Where they talk about the use of this adjunct Afloat in a type of Role 2 type of setting. So not just by the US military,
but by many international militaries as well. And then finally we are extending this REBOA training paradigm, this is a Journal of Special Operations Medicine, a JSOM paper where many of our young surgeons are describing bringing REBOA closer to the point of injury and training
highly capable special forces medics and arterial access and this procedure. So in summary, you know we've written in this War on the Rocks commentary I refer you to for more descriptions of these topics. You know, we learn from but we don't plan for the past wars
in order to keep our national strategic edge of a sub-10% case fatality rate. We've got to try these new approaches, these new technologies. REBOA is one example of those. And now we have the need to gather clinical data
from this and other technologies to determine their optimal use. And requirements for future technologies. Thank you very much.
- [Jean] Thank you, Will, thank you again, Frank, for inviting me to your symposium. I'm going to talk to you about this concept of the value of EndoAnchors and TEVAR, and if you talk about that, basically, you need to figure out if we can predict TEVAR failure. So we published, last year, the creation of a novel
that makes a severity grading score to assess thoracic aneurysm and see if we can actually predict the patient that will not behave nicely with a simple TEVAR. Here's an example of two scores. Patient with an ASG score of 24
and the other one with an ASG score of 43. And the top of the ASG score is all the way up to 57 if you have all the worst characteristic that is applied to the different region of the thoracic aorta. So we found by doing a ROC Curve analysis
that an ASG score of 24 was actually the cut off, and below 24 was the low score group. And 24 and higher were patients with the really bad, challenging anatomy. And those patients had only a 69% freedom
from postoperative endoleak, requiring re-intervention at two years. So this novel anatomic severity grading score can actually really successfully identify patients that are at increased risk of endoleak requiring re-intervention
and then it would make sense in those patients to potentially apply for prophylactic EndoAnchors. And this is what we did in this next study where we looked at only patients with a high ASG score. So we had 63 patients with those high scores. 40% had only TEVAR and under the 20 patients
had TEVAR and prophylactic EndoAnchors as well. And if you look at those patients that only had TEVAR and bad anatomy, we had a 58% chance of freedom from aortic related re-intervention at three years. The 62% freedom from Type I endoleak at three years.
But when you place prophylactic EndoAnchors you end up with an excellent result with 95 to 100% survival free from any of those two kind of problem. So this would be the value in using EndoAnchors and these are better to me now. The technique for the thoracic EndoAnchor
and compared to the abdominal is that we have the selection of three potential active guide size, 22, 32, 42. And we size it according to the size of the endograft. I say as an example of a patient with challenging anatomy that was the patient with the ASG score of 43. This patient had a hemiarch debranching
and then we went ahead and deployed the endograft and deployed the EndoAnchor at the inner arch. This is the completion angiogram after those prophylactic EndoAnchors. And there is no endoleaks at two years. This patient is now currently at over three year follow-up
no migration and no endoleak, despite an extremely challenging anatomy. You can also have another prophylactic indication is to prevent upward migration. If you look at the tapering of the thoracic endograft right above that celiac artery,
this is really an area that in fact in the Valor II trial, has really showed that a lot of patient have Type 1B endoleak after a few years. And by using circumferential placement of those EndoAnchors at the distal end of the TEVAR,
you can really prevent this upward migration and endoleak 1B formation. Now the technique it's really about the angle of attack. I think if you have a bad angle of attack, you will not be able to deliver properly. But when you have a real 90 degree perpendicular attack
of the endograft this is how you can safely deploy those EndoAnchors in the thoracic aorta. This is a deployment of the ascending aorta in an RAO view, so you can not only deploy at the inner curve, but you can also deploy EndoAnchor on the interior or posterior aspect of the arch
by deploying anchors with these special view with the barrel. When you look at the outer curve of the arch, this is an easy Zone 1 delivery. This is a more tricky Zone 1 delivery, but it also possible to deploy EndoAnchors
in the outer curve. Same thing when we have the sternum open to do a total arch debranching, we can deploy EndoAnchors in an antegrade fashion in Zone 0 and obtain also great result. Top 10 tips for EndoAnchors.
First is take the time for preoperative planning. Second one is wishful thinking will not create the landing zone. Sometimes you have to do some debranching to obtain a landing zone. Deliver the endograft accurately.
Do the aortic balloon molding first. You have to size the Aptus guide according to the endograft size. You have to undersize it when you want to use it at the level of the outer curve of the arch. You deploy two rows in TEVARs.
I always deploy three rows in arch because of the increase in hemodynamics at that level. I think a good place to learn to do TEVAR and EndoAnchors is the distal end near the celiac artery. And never start a challenging TEVAR case without EndoAnchors.
So in summary, EndoAnchors in TEVAR are done in imperfect landing zones, improve outcomes by decreasing Type I endoleaks and the need for aortic reinterventions. Safe and effective deployment of EndoAnchors really relies on simple techniques, device selection,
and the knowledge of the failure modes of doing TEVAR in those challenging zones. Thank you.
- Well, if fenestrated EVAR is so great, why isn't everyone doing it? And I would submit it has to do with the planning. If you have a perfectly planned procedure, the procedure will go perfectly. These are my disclosures, which are directly related to this presentation.
This is a case that was planned using AortaFit software and it was a case that we identified as being a perfect plan. We went back and looked at our fellow and resident in our training program who we trained to plan these procedures and asked them to plan this case.
Our first trainee submitted the following plan. And when we line up the SMA, we lose the left renal on this plan. We then asked our fellow to plan the case and she provided this plan.
When we line up the SMA on this case we lose the right renal. So, it tells us that there is tremendous variability in human planning. We participate in the VQI in the Pacific Northwest Regional group,
and we perform 88% of the complex EVAR in our region. And we have the lowest procedure times, the lowest estimated blood loss compared to the rest of the nation, the lowest in post-operative complications, excluding death, and the lowest in composite outcomes to include major cardiac events.
We also have the highest rate of return of our patients to a pre-surgical care setting. So how have we achieved this? Using AortaFit software, we are able to take a standard DICOM data set of a juxtarenal aneurysm patient and create a volume rendering.
We can then display the images in an axial, sagittal, and coronal view for the user. All that the user needs to do is to identify the target vessels and to plant seed points into those target vessels, the target vessels that are selected to be preserved.
What is then output from the software is a segmentation. And you see the segmented image here, but the magic of the software is that it does the automatic adjustment of the centerline using polynomial equations and goodness of fit. We can superimpose 2D slices over this to check
our orientation of the fenestrations and look at the plugs. And what's output is a graft plan that can either be given to the physician in the form of a 3D printed template or placed on the back of a manufacturing line. Sorry. So, for the physician, an STL file can be produced
to create a 3D printed template to create a physician-modified endograft, but what we really want is to be able to provide the manufacturer with a detailed plan using this software. This is an example of a Terumo Aortic TREO device. We've now done 37 of these cases.
This is a graft that has wide amplitude stents and a large amount of real estate for fenestration. So you can see inserting this 3D printed template that was created using AortaFit software. We can rotate this graft, move it in and out to find the sweet spot
for those fenestrations, and to create a truly customized device for the patient. We then, all that we have to do at that point is to line up the SMA. So you can see, on the panel on the left, we do our first aortogram
prior to deploying the stent graft. We deploy that SMA fenestration, the renals automatically align. We then select our renal arteries and then our fellows know that it's time to call for the next patient because the procedure is essentially done at that point.
This is a cone beam CT of that very first patient that I showed you, showing perfect alignment of all of the fenestrations and target vessels. And here's a 30-day follow-up CT scan, that if you pay attention and look carefully, you can see that all of the fenestrations
are perfectly aligned. There's about four centimeters of seals on length, and lack of endoleak and a successful result in this patient. This, fortunately, is published in this month's Journal of Vascular Surgery as an editor's choice.
And in summary, the long-term durability of fenestrated EVAR has been established, but planning and procedural complexity limits widespread adoption. Automated planning software, we believe, provides efficient and accurate graft plans for the physician
or endograft manufacturer. Well-planned grafts simplify branch access and the procedure and I think will increase fenestrated EVAR utilization. And simplified FEVAR may benefit the majority of patients harboring juxtarenal aneurysms and even standard infrarenal aneurysms and may be the best therapeutic option.
- So regarding fenestrated limbs, these are my disclosures. Typical scenario where you have a rather unwelcoming iliac, common iliac artery, you need around 16 millimeters at least to accommodate a branched graft in the iliac artery. You want to preserve the hypogastric flow.
In this case you also see a stenosis, so you need two things, ideally, to accommodate a branched device, which would be the diameter of 16 millimeters and also the angle of the artery. This is very pleasant to put in a branched device.
However, there are patients where you want to preserve the hypogastric blood flow, and in these cases, above the origin of the hypogastric artery, there is not enough room to open up a branched device, or the angle is very unfavorable
to put in a branched device. And here fenestrated iliac limbs come into play. These are usually made to measure, different lengths, different proximal and distal diameters and also you can place the single fenestration where it obviously is positioned best.
There are basically two, I think very useful indications. Here we can see a type 1B endoleak in a 13 millimeter limb. The distance to the hypogastric artery was not enough to have a full expansion
of the iliac limb, and therefore in this case if you want to preserve the hypogastric artery, which I would really strongly always recommend if possible, is to put in a fenestrated limb. But it's also really very helpful in these cases
is that you don't have to come from above, you can come from below and finish the whole procedure from below. So you have a full deployment of the endograft and then you'll put in a connecting stent graft
with obviously a very good seal and result. Most importantly, for complex cases as in this, for instance, patient who's had an open procedure 10 years previously and had further interventions with an over-stenting of the hypogastric on the right side and large thoracoabdominal aortic aneurysm
as well as an anastomotic aneurysm on the left side, you really want to preserve the hypogastric artery. And you can also that actually it's an anastomotic aneurysm at the left side, so here a branched device certainly doesn't work. First, because it doesn't open up,
and second, the angle of the hypogastric is really very unfavorable. So again, you just put in your fenestrated device and then connect it from below with the stent graft in order to preserve the hypogastric blood flow of the last remaining hypogastric artery.
And also, obviously do something else to the rest of the patient, so this was a five branched endograft in a patient with two left kidneys. And also another case, you see actually on the angiography already the shaggy aorta,
so occlusion or seal at the distal origin of the common iliac just above the hypogastric is not really a good option, so we've re-over stented, or you do something about it. Now this is the case with a thoracic endograft
and a full-fen extension. So again, we really opt to preserve these hypogastrics as much as possible. So in conclusion, Mr. Chairman, (coughs) sorry ladies and gentlemen, fenestrated limbs are a good tool to preserve
hypogastric arteries. Now just to put it into perspective, is it common? No, we have around 30 branched iliac devices a year we implant, and we had all in all five fenestrated during the last two years.
So this is really a rare anatomical solution, but I believe it really is helpful. It's not an off-the-shelf device, so it takes around four weeks to produce, and the company's still not really decided how to price it, so we really can nicely negotiate it.
Thank you very much.
- Thank you. We are all aware, of course, of the landmark trials that established the evidence basis for the current standard of care for triple A management, especially the EVAR-1 UK trial that, among other things, provided us with a acronym that we use every day of our lives at the present time.
I don't know about you, but I think, as far as I am concerned, it escaped me for a few years, perhaps at the time, that 90% of these patients included in the trial were Caucasian men. So this is something to be considered, of course,
because the evidence in the results may or may not be applicable to other human populations. They used, of course, first generation devices. These trials were designed and planned some 20 years ago, mainly for the EVAR-1 trial, the Zenith and the Talent devices.
We learned four years later that the post-op complications, complications were higher in the EVAR group and so was the re-intervention rate, 20% versus 6% for open surgical repair. Similar all-cause mortality. More than 50% of aneurysm-related mortality
after 30 days was due to aneurysm rupture. We learned also, importantly, that aneurysm rupture was largely related to graft problems and complications. So there was a clear need for improvements there. In Charing Cross 2010, eight years ago, we learned that with the presentation
of the 10 year follow-up of that cohort, that at year number six, the advantage of aneurysm-related mortality was lost on EVAR patients versus their surgical counterparts. There is a sense that we are definitely doing better today. Because technologies are much better,
perhaps we have gotten a little better. I'm not sure about that. So is this true? Probably so, but the ENGAGE Global Registry perhaps is one way to approximate to that answer. A very large study sponsored by Medtronic
and focused on the use of their ENDURANT device, very few limitations, the so-called real world type of practice. Of course, I had to have comparison, is difficult to make, and perhaps not totally realistic, because these are two very different studies.
But nonetheless, I think there are some significant lessons to be learned and digested here. For instance, re-intervention rate. A 35% reduction with ENDURANT versus the EVAR-1 patients. It's similar, all-cause mortality again, as we might expect. But an impressive nearly 50% reduction
in aneurysm-related mortality, which clearly was a significant problem in the early years of EVAR. Death from rupture, also significantly lower, approximating the rate after open surgical repair. So I think these are important facts.
They're not limited to ENDURANT. Certainly, there are other devices that have produced and are producing and published similar good outcomes. We have come a long way. And it seems to me that the main problem that we have now may be, at least in part, the result
of these enhancements and improved technologies, because the main cause of problems in poor outcomes today, I think unquestionably is us, you and I, because we continually push the envelope, become more and more aggressive, do EVAR now in more than 80% of all cases in off-label use.
Thanks very much.
- Thank you for the opportunity to present this arch device. This is a two module arch device. The main model comes from the innominated to the descending thoracic aorta and has a large fenestration for the ascending model that is fixed with hooks and three centimeters overlapping with the main one.
The beginning fenestration for the left carotid artery was projected but was abandoned for technical issue. The delivery system is precurved, preshaped and this allows an easy positioning of the graft that runs on a through-and-through wire from the
brachial to the femoral axis and you see here how the graft, the main model is deployed with the blood that supported the supraortic vessels. The ascending model is deployed after under rapid pacing.
And this is the compilation angiogram. This is a case from our experience is 6.6 centimeters arch and descending aneurysm. This is the planning we had with the Gore Tag. at the bottom of the implantation and these are the measures.
The plan was a two-stage procedure. First the hemiarch the branching, and then the endovascular procedure. Here the main measure for the graph, the BCT origin, 21 millimeters, the BCT bifurcation, 20 millimeters,
length, 30 millimeters, and the distal landing zone was 35 millimeters. And these are the measures that we choose, because this is supposed to be an off-the-shelf device. Then the measure for the ascending, distal ascending, 35 millimeters,
proximal ascending, 36, length of the outer curve of 9 centimeters, on the inner curve of 5 centimeters, and the ascending model is precurved and we choose a length between the two I cited before. This is the implantation of the graft you see,
the graft in the BCT. Here, the angiography to visualize the bifurcation of the BCT, and the release of the first part of the graft in the BCT. Then the angiography to check the position. And the release of the graft by pushing the graft
to well open the fenestration for the ascending and the ascending model that is released under cardiac pacing. After the orientation of the beat marker. And finally, a kissing angioplasty and this is the completion and geography.
Generally we perform a percutaneous access at auxiliary level and we close it with a progolide checking the closure with sheet that comes from the groin to verify the good occlusion of the auxiliary artery. And this is the completion, the CT post-operative.
Okay. Seven arch aneurysm patients. These are the co-morbidities. We had only one minor stroke in the only patient we treated with the fenestration for the left carotid and symptomology regressed completely.
In the global study, we had 46 implantations, 37 single branch device in the BCT, 18 in the first in men, 19 compassionate. These are the co-morbidities and indications for treatment. All the procedures were successful.
All the patients survived the procedure. 10 patients had a periscope performed to perfuse the left auxiliary artery after a carotid to subclavian bypass instead of a hemiarch, the branching. The mean follow up for 25 patients is now 12 months.
Good technical success and patency. We had two cases of aneurysmal growth and nine re-interventions, mainly for type II and the leak for the LSA and from gutters. The capilomiar shows a survival of 88% at three years.
There were three non-disabling stroke and one major stroke during follow up, and three patients died for unrelated reasons. The re-intervention were mainly due to endo leak, so the first experience was quite good in our experience and thanks a lot.
- [Clark] Well, dear chairmen, Frank, thanks for the invitation. In this talk, I'd like to focus on the role of calcifications in the aortic wall, and whether we could use it for clinical risk assessment. My disclosures. Well, an aortic calcification is, of course,
a clear anatomical entity. It's not that difficult to visualize it. Obviously, for a meaningful assessment, we need to quantify it. This can be done by a simple, abdominal aortic calcium score, AAC 0.8.
The severity of calcification is measured in points assigned to the presence of high-density signaling on the anterior and posterior walls of the aorta between the first and the fourth lumbar vetrabra. The cumulative points of both anterior and posterior walls represent the AAC 0.8 score.
This is a cut from (mumbles) for event-free survival in 2 1/2 thousand individuals, and it shows the prognostic value of AAC for cardiovascular outcomes. A high AAC score predicts future events, and it says something about overall survival.
Now, occlusive and aneurysmal disease are not the same, but calcifications also occur in the aneurysmal wall, and they can be assessed with CTA, quite simply. The effects of calcification are unclear, and we don't know whether it's protective or it's generative.
To verify the roles of these calcifications, patients with an aneurysm confirmed by CT in a six-year period were included. Three groups were distinguished on the likelihood of rupture. The elective group were patients,
who had received elective surgery. Acute aneurysms were either symptomatic, nonruptured, or ruptured confirmed CTA. Doing so, significant differences in diameter and calcification were found between ruptured and elective patients.
Using the AAC score, symptomatic patients were significantly more calcified than elective ones. Then after logistic regression, comparing elective versus nonelective aneurysms, female gender came out as the most important risk factor. Compared to diameter, the AAC was better able to distinguish
acute from elective aneurysms. Now, it's obvious that the conclusions of the few studies we have on the prognostic value of calcification in triple A, directly linked to reliability of the methods of measuring the extent of calcification.
Fully quantitative measurements are considered to be best. Mass and volume and several software tools are currently being used, but without exact knowledge on accuracy or, ultimately, use of these tools. This one, we used the Phantom with calcium rods
of pre-established, massive volumes, which were scanned with the specifics D protocol for coronary arteries and one for the abdominal aorta. This was done to see whether calcification tools tested on coronary arteries can be directly applied to the aorta without adjustments.
Five CT scans for each protocol were performed, and the Phantom was moved two to five millimeters in a random direction between each scan to mimic patients' movement. For each measurement tool and for both scanning protocols, the mass and volume were greatly overestimated.
It appears that the error and the variability of the results increased, when the size and the mass of the calcium element decreased. Also, the presence of contrast has a significant effect on aortic calcification's course. To assess the size of this effect
on the clinical conditions, 50 four-phased liver CT scans were retrospectively collected and analyzed in patients over 65 years of age. The first phase was with contrast, followed by three... No, without contrast followed by three contrast
and have phases of different intensity. Here we saw that measuring calcifications under contrast-enhanced conditions overestimated the calcium volume by a significant margin, yet it underestimated the mass of calcification significantly.
As the results, there's no provision factor to adjust for the error. Clinically-relevant small calcifications are most erroneously measured. Tools validated for coronary arteries that can now be extrapolated to the abdominal aorta,
and patients will need two instead of one CT scan, so, with and without contrast. Most striking, I believe, the previous research using calcification scoring tools on the abdominal aorta, especially with contrast, should be highly scrutinized. As a final conclusion, I think it's clear
that before future studies are implemented, we should first harmonize protocols and software packages to get reliable calcium measurement results. Thank you for your attention.
- Good morning everybody. So first of all let me take note of it for the kind invitation to be here, again. These are my disclosures. So Juxtarenal Aneurysm has been described as those aneurysms very close to or even including in the lower margin of renal artery.
And of course the gold standard at that time was aortic supportive clamping and open surgery. Probably open surgery is still the first choice in this very short and complex aortic neck but what do in case of patients unfit for surgery? Or for patients who are asking for
a minor invasive alternative. Of course, Fenestrated EVAR are the solution, the option two, but they require time, are expensive, so what to in case of patients who have no time or cannot wait for this customization process?
Symptomatic patients, patients with huge aneurysm or patients just unfit for fEVAR because of either access or tortuous proximal neck anatomy. So solution is chimney or ovation VENT. What is ovation VENT? It's a kind of open chimney technique,
it's a combination of ovation with renal bare stent. So you know the the new concept of sealing of this stent graft, the circumferential apposition of polymer-filled ring to the aortic wall, typically at 13mm, so to just translate the length of the neck to a specific point
when a couple of millimeter when in that position of course. And you know with the previous, you have just heard the harder device, but with the standard device, the prime and the IX, we have the device positioned
13mm below the lowest renal artery. So, what to do in case of (unclear) when have no apposition of the ring to the aortic wall, we raise the ring, just very close to the renal artery, and then we place some bare metal stent
at the renal BMS. So here you can see our bench test with the fabric of the collars just moved by the bare metal stents. So, VENT is different from chimney, we don't use the covered stents so
it's a lowered provide bracket approach, and more importantly, chimney and endograft are typically competing for the same room so this the reason for gutters, while with VENT we have a stent and endograft, which are not competing for the same room.
The ring is responsible for the sealing and the stent is just responsible for the ventilation of the renal arteries. So this is a typical example, you can see here, a contained rupture aneurysm, in this point, and with a very short neck, so we decide
to land with the first neck and exactly at that level you can see here the steps of the procedure, the contemporary deployment of the renal stent, and the main graft the injection of the polymer, so the first ring is really in contact with the renal stent,
but they're not competing each other and so you can have a nice sealing of the sack. Another case, conical shaped neck, unfit for standard EVAR, unfit for EVAR, because was a huge aneurysm, much more than 8cm, so we decide again to raise the ring,
13mm and fit for standard ovation. And so here you can see the first ring just at this level, the renal stent, responsible for the patency of the renal artery, and you can see here that the first ring is just touching it in one point, the conical neck.
With good sealing. Again, another case with unfit for fEVAR, because of the small access, tortoise access, and so we plant a double VENT, in this case, you can see here again, prucodanus bracket approach, with five french shift,
contemporaneous deployment of stents, and first ring, again nice sealing, and nice follow up with completed sack screen cage, and another one year follow up. So, up to now we have performed 29 cases. We did the first case in June 2015,
technical success was high, 96.6%, we had just one type one endo-leak fixed introaperticaly with the coil embolization. The follow up is, mean follow up is 19 month, and 100% renal artery patency, no further intervention, no sac enlargement,
the majority of arteries, it's shrinkage more than 5mm. So just in conclusion, this option is in, we believe that in selected measures, it's a nice option. It is safe and effective when you can not wait for fenestration graft, like in case of symptomatic
or huge aneurysm, or just patients are unfit for fenestration because of tortuous anatomy or small iliac vessels. Thank you for your attention.
- Thank you, Dr. Veith. Mr. Chairman, ladies, and gentlemen. I've no disclosure for this talk. However, one of the co-author is a consultant for Cook Medical. We know that the endovascular treatment for rapture thoracoabdominal aneurysms is increasing lately.
And with the great advantages, in term of, mortality and morbidity, particularly, if we consider pulmonary morbidity. Given these results, endovascular treatment has been employed these several centers and as you can see, some of these centers
used technique with a t-Branch endograft device. As you have seen this morning in different presentation, the Zenith t-Branch device is a four-branches device with branches for the visceral vessels is a 22 French delivery system. And as you can see here, there are branches
for all the visceral vessels, specifically SMA, celiac trunk, and the two renals. This kind of configuration allows you to treat cases like the one you can see now. The other case of rapture which is shown in this slide here. So what we have to see if there is an anatomical suitability
of t-Branch stent-graft and the results, we can obtain in this setting. Obviously, we have to perform a plan according to the characteristic of our t-Branch device. And according with these characteristics the eligibility criteria
in the normal TA thoracoabdominal aneurysm is up to 88%. However, if we consider rupture cases, these eligibility can be as low as 22% with some papers describing 33% anatomical suitability. In our series, we have a 40% possibility of accommodating these endograft.
So the results we can obtain are shown in these next slides. As you can see, we have 17 cases treated urgently. Of those, four had a contained rupture. Other four were symptomatic and nine cases had a diameter greater than eight centimeters. These cases has been described in this study
published last year in Journal of Vascular Surgery. And we had a technical success of 75% only in the ruptured cases. One case was not accomplished due to inability to cannulate the renal artery. I show you that the this inability
was caused by different orientation of the renal artery. We described different kind of orientation with possibility of cannulating them in a paper published this year in a European Journal of Vascular and Endovascular Surgery. There were three cases of reintervention at 30 days as you can see here.
And again by putting together all the cases treated in a multicenter study performed in Italy, the there is a quite good survival overall in thoracoabdominal aneurysm treated by endovascular means. However, the survival in patient with ruptured aneurysm is significantly lower as everyone can expect.
So in conclusion, we see that the emergency treatment with t-Branch is technical feasible in many instances and in ruptured cases there are a number of anatomical obstacles, which can violate the suitability of the t-Branch device. However, with the adjunctive devices and team experience,
we can overcome these obstacles and get good overall result in this difficult setting. Thank you for your attention.
- Thank you, I have no disclosure for this presentation. Aorotopathy is a different beast as oppose to patients with dissections that we normally see in the elderly population, but we have the same options open surgery, endovascular, and hybrid. If they all meet the indications for surgery so why not open surgery?
We know in high volumes centers the periprocedural mortality acceptable in especially high volume centers. The problem is the experience surgeons are getting less and less as we move into more and more prevalence of endovascular. And this is certainly more acceptable in lower or
moderate high risk patients. So why not be tempted by endovascular in these patients? (to stage hand) Is there a pointer up here? So the problem with aorotopathy is the proximal and distal seal zones and we've already heard some talks today about possible retrograde dissection,
we've also heard about nuendo tear distally and aorotopathy is certainly because of the fragile aorta lend itself to these kinds of problems. But it is tempting because these patients often do very well in the very short term. The other problem with aorotopathy is they often have
dissection with have problems for branch unfenestrated technology and then of course if these dissection septum are near the proximal and distal seal zones, you're going to have a lot of difficulty trying to break that septum with a ballon and possibly causing new
entry tears proximally or distally. Doctor Bavaria and his colleagues from Italy were one of the first ones to do a systematic review and these are not a large number of patients but they combined these articles and they have 54 patients. Again, the very acceptable low operative risk, 1.9%.
But they were one of the first ones to conclude and cation that TEVAR in these patients, especially Marfan's patients in this series carries a substantial risk of early and late complications. They actually cautioned the routine use of endovascular stent grafts.
One of the largest series, again stress, these are not large numbers but one of the largest series was just 16 patients and look at this alarming rate of primary failure. 56% treated successfully, 40% required conversion to open operation and interestingly enough
43% of those patients had mortality. My friend and colleague at the podium, doctor Azizzadeh was given the unbeatable task of arguing for endovascular therapy in Marfan syndrome and the best he can come up with was that midterm follow up demonstrates sizeable numbers of complications but,
he identify area where probably it was acceptable in patients with rupture, reintervention for patch aneurysms and elective interventions in which landing zone was in a synthetic graft. So why not hybrid? Well this seems to be the more acceptable version
of using TEVAR, if you can, in these aorotopathy patients. But this is not a great option because in this particular graft that you see this animation, we're landing in native aortic tissues. So really, what you have to do is you have to combine this and try to figure out a way to create a landing zone,
either proximally or distally and this is a patient and not with Marfan's this time but with Loeys-Dietz, who we had presented recently, previous ascending repair but then presented with horticultural abdominal aneurysm as a result of aneurysm habilitation of a previous dissection and here
you see a large thoracal abdominal aneurysm on the axial and coronal and as many of these patients with aorotopathy express other problems with their multisystem diseases and you can see the patients left lung is definitely not normal there, left lung is replaced with bullae and this is a patient who would not do well
with an open thoracal abdominal repair. So what do you do? You have to create landing zones and in this particular patient, he had a proximal landing zone so we were able to just use a snorkel graft from the mnemonic but distally we had to do biiliac debranching grafts to to all his vistaril arteries
and then land his stent-graft in the created distal zone and as you can see, we had an endoleak approximately and thank goodness that was just from a type II endoleak from the subclavian artery which we were able to take care of with embolization and plugs.
And there is his completion C.T. So not all aorotopathy is the same, this is a patient who presented with a bicuspid aortic valve and a coarctation and I would submit to you, this is not a normal aorta. This is probably a variant of some sort of aorotopathy,
we just don't have a name for it necessarily, and do these patients do well or do worst with endovascular stent-graft, I just don't think we have the data. This particular patient did fine with a thoracic stent-graft but this highlights the importance of following these patients and being honest with the patients family and the
patient that they really do have to concentrate on coming back and having closer follow up in most patients. So in summary, I think endovascular is acceptable in aorotopathy if you're trying to save a life, especially in an acute rupture or in an emergency situation, but I think often we prefer to land these
endovascular stent-graft in synthetic. Thank you very much.
- [Narrator] Thank you, thank you Dr. Veith and the committee for the kind invitation. No related disclosures. Carotid webs are rare, noninflammatory arteriopathy that are also known as pseudovalvular folds, as well as other pseudonyms for this. They are small, shelf-like linear filling defects,
arising posteriorly from the posterior proximal-most ICA and project superiorly into the lumen. They're generally regarded as a developmental anomaly of the brachiocephalic system, and histopathology lacks atheromatous changes and inflammation of the tunica intima.
They may be associated with FMD, or be considered an atypical form of intimal fibroplasia, and generally arise from dysplasia within the media. They will as we will see, carry a considerable stroke risk based on laminar flow disruption and irregular shear profile.
This is the mechanism by which they produce strokes, seen clockwise from the top upper-left. There are areas of stasis in which thrombus can develop behind the web. The thrombus can enlarge and eventually embolize. Operative findings and pathologic findings include
these webs seen here behind this nerve hook, and generally smooth muscle with extensive myxoid degenerative changes. Over the last several years we have treated 10 patients with carotid endarterectomy for symptomatic webs. The mean age of these patients
is generally quite young, in the 40s. The majority are female, one patient had a bilateral web and 70% of these patients had no atherosclerotic risk factors whatsoever. The mean maximum peak systolic velocity on duplex was 77 centimeters,
and five of the cases were closed primarily without a patch. There were no strokes perioperatively in this group, no mortalities, and there have been no new neurological events nor restenosis. Several other groups have looked at this phenomenon as well,
this is a case series of which 7 patients were identified prospectively having had an ischemic stroke. Again, the mean age was young. Of note, five of these patients had a recurrent ipsilateral stroke to the web. No FMD was seen throughout the other vascular beds
and four out of five of these patients, the recurrent patients had CEAs with no recurrence at approximately a year. Another review identified 33 patients who had excellent CAT scan imaging. These were younger patients over a six year period,
with cryptogenic stroke. The prevalence of webs within that group was 21%. Symptomatic patients within that group with webs were 7 patients out of 33 and again you see a young age, predominance of women,
in this study of predominance of African American patients 3 bilateral webs, all patients had MCA infarcts. And oh, 1.6% of the webs in the control group were without a stroke. Another case-control study looked at 62 cases over four years.
They were able to match 53 of these patients with other cerebrovascular pathology, webs were found in 9% of the cases, but only 1% of the controls. And again of the webs, predominance of young patients
and women with two bilateral strokes. So what about diagnosis? Even large webs generally do not meet the velocity criteria for significant stenosis, and while you may see a filling defect, you're generally dependent on B mode imaging,
and having a high level of suspicion, for identifying this process. CTA is the gold standard, it's got rapid, high-resolution imaging, reformatting across planes, makes this an excellent modality
in associated findings of thrombus, and atherosclerosis can also be detected. Angiogram again, as always, gives you a good view of flow dynamics, intra and extra cranial pathology, and in general the finding is of contrast pooling,
which you have to look for behind the web. MRA is one method that's been used to characterize this, in this modality you can see slowed blood flow distal to the web, blood pooling distal to the web, and generally this all leads to an atypical pulsatility, of the carotid wall near the area of the web,
suggesting impaired hemodynamics in this condition. Management is with a carotid endarderectomy which has been the preferred treatment, although some have advocated medical management with formal anticoagulation, patients have had strokes
while on anti platelet therapy, and there are several case series now appearing of acute stroke treated with stents, these are generally delayed following thrombectomy. There's one latrogenic dissection in these groups. These patients have few atherosclerotic risk factors,
in the same demographics as noted above. So in conclusion, these are associated with FMD and intimal fibroplasia. The prevalence is low. The prevalence may be increasing but it's not clear whether this is a true prevalence increase,
or simply increased detection. They're associated with recurrent symptoms even in the setting of adequate medical therapy and is an underappreciated cause of stroke, and are now becoming a recognized, and rather than a cryptogenic cause of stroke.
They are generally not identified by current duplex criteria in asymptomatic patients, and duplex may miss them entirely. Axial imaging is essential and currently we don't stratify these based on either legion characteristics or demographics.
So while the optimal management is not completely defined given the recurrent stroke risk CEA seems prudent especially in young, medically fit patients with or without patch angioplasty, which may have some impact on quality metrics
at least in the United States. We've treated patients with three months of antiplatelet therapy, aspirin indefinitely. Right now the role of statins is undefined, and the durability and role for endovascular approaches remains also undefined.
- Speaking about F/EVAR and Ch/EVAR, and try to prove that the evidence of Ch/EVAR is solid, especially in some circumstances also better than the evidence about F/EVAR. Well, let's try to define this title. Durability of Ch/EVAR is solid if the procedure is done right.
And I think this is very, very crucial. We heard and we know the PERICLES Registry tried to evaluate this technique, collecting the worldwide experience from 13 US and European university centers, and published in annals of surgery.
And also, the PROTAGORAS study focused exactly on the performance of the Endurant device in order to avoid this heterogeneity which we had in the study (mumbling) published literature up to now. Focusing exactly on the Endurant device
in combination with balloon expandable covered stent. And based on these two registries and studies, we identified four key points, four key factors, which we'd like to give you as take home message in context to have the Ch/EVAR technique as solid procedure. So, we learned that the technique performs very well
if we use the technique for single or maximum double chimney grafts. We highlighted how important it is for this technique to use suitable combinations between aortic stent-graft and chimney devices. And we learned also, how important is the oversizing.
We have to have enough fabric material to wrap up the chimney grafts of 30% of the aortic stent-grafts. And in this context, we highlighted also the importance of creating a new sealing zone of 20 millimeter in order to have durable results.
Which is also very important is to know when we should probably avoid to perform the technique, and I would like also to highlight these points. So, we learned in case of excessive thrombus formation in the thoracic, especially also LSA, we have to be very, very careful with this technique,
because of course, we have the risk of cerebral vascular events. We learned also that performance of this technique in a neck diameter of more than 30 millimeter is associated with high risk of Type 1A endoleaks, which will be persistent, and which probably
lead to failure of the treatment. Which also learned is to evaluate very carefully the morphology of the renal arteries, especially focus of the calcification of the stenosis, and also of the diameter. And last but not least, it's very important to
have access to the suitable materials for renal cannulations, and also experience. So, if we consider these key points of doing and not doing chimneys, I think we have a very good base to have durable and good results over the time. And we have seen that.
You saw it very nicely (mumbling) the changes of the diameter pre and postoperative, but you forgotten to highlight that there was highly significant in the PERICLES and in the PROTAGORAS Registry. Also, what we have seen is that
more than 90% of the patients had stable or shrinkage of the sac after a CT follow up of two years. And here's a very nice overview of the Kaplan-Meier curves, highlighting that the technique performs very well in this specific combination of the Endurant devices,
abdominal device, and abdominal chimney grafts like the Advanta. Having a very nice chimney graft patency of almost 96%, and a freedom from chimney graft later interventions of 93%. Very important is also if we create these very good sealing zone of two centimeters.
We have a very, very low incidence of new Type 1A endoleaks needed reintervention. And here is an example of a case which had a very short sealing after the previous treatment with chimney for the left renal artery, and over the time was necessary to extend the sealing zone,
creating these durable solution and transformating from single to triple chimney, as we can see here. So, this is very important to know and to highlight. In context of the better or not better for F/EVAR, we can see now the results, and we've compared with meta analysis of F/EVAR.
We see that the results are similar. Keeping in mind also that in F/EVAR, we involve the SMA either as scallop or as bridging device, and we don't have evidence about the SMA outcomes and the SMA patency because most of the patient probably who will die, and will not perform autopsy
for each patient if it has an SMA occlusion or not, so I believe it is underestimated the really incidence of survival after F/EVAR. And also, regarding the patency, we have also in this context, similar results after chimney compared to the patency of the bridging device after F/EVAR.
So, ladies and gentlemen, I believe we've considered these key points. We can achieve very good results performing Ch/EVAR, having as a solid and valuable procedure for our patients. Thank you very much.
- [Lu Qingsheng] I have no disclosures. We know for indication of EVAR we need favorable proximal neck anatomy but if it not unfavorable maybe we are some Type 1a endoleak it's a serious complication for EVAR. So for prevent and treat Type 1a endoleak
especial for some juxtarenal aneurysm maybe we use the chimney fenestration branch and some sac bag. Could we find a simple safe cheap and effective method? So we find from open surgery we were introduced this fibrin glue
means its complex of thrombin and fibrinogen, it's used hemostasis in open surgery so we put that into inject that into the sac, we call it fibrin glue sac embolization. I will show you some cases.
For this case is very short neck and not quality of deck and after deploy the stent graft, of course very serious Type 1a endoleak. But fortunately, we put a catheter before we deploy the stent graft so this catheter is into the sac of the aneurysm
then we use up a long controlled blood flow and we inject from the catheter into the sac of the aneurysm and we inject the fibrin glue. And you can find the contrast not moved after we withdraw balloon. Then we do the angiogram.
We find no any endoleak. Another case showed is angulated neck as this patient. Of course after we deployed stent graft have a lot of endoleak. And we do again this technique. And control the balloon, control the blood flow,
then inject the fibrin glue, and we check all that and withdrew the balloon, there are no any movement about the sac. And we do the angiogram and no any endoleak. Till now, we did, we begin this technique 2002, so we follow long time that we can show it's safe.
So till now we treat 156 cases and proximal less then short proximal neck is 75 cases even some of less than 10 millimeters. And angulation more than 60 degree even some cases more than 75 degree.
Most of them more than 98% of patients' endoleak was resolved. And during our follow up, the mean time more than 100 months, only three patients died of aneurysm related sac enlargement.
The mean maxim aneurysm diameter decreased and no recurrent Type 1 endoleak so we have confidence that it's safe and no any sealant-related complication for example renal failure and aplasia other things. So we discuss the mechanism
it's not only embolization for endoleak but also coagulating all sac of aneurysm like this in shows how it worked. And we also measure the pressure in the sac. Intrasac pressure decreased significantly in treated cases. And how about that technique we need occlusion
proximal blood flow and protect branch ateliers and prevent distal embolization. And we also treated into the rupture aneurysm and it can treat any type of endoleak as these cases it's a rupture aneurysm we do the EVAR emergency.
And after we deploy this devices, we find this endoleak. We don't make sure which kind of endoleak but anyway we just do that, control the blood flow use the balloon then inject the fibrin glue in that.
And all the sac of aneurysm. Then we do the angiogram and endoleak disappeared. We'll be treat any type endoleak of the rupture EVAR we prevent rupture post-EVAR and we decreased abdominal compartment syndrome. So the conclusion is
fibrin glue sac embolization is a simple and effective treatment method. And this method could expand the current indication of EVAR. For selective the length maybe can to the 5 millimeters, angle maybe can to the 90 degree,
and for emergency we seen it should be into the older EVARs for rupture aneurysms. Thank you very much.
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