- [Presenter] Thank you very much, Mr. Chairman, and thank you to Frank for the kind invitation, and I'm going to be talking about the Nexus Single Arch Branch Endograft System for treating the aortic arch lesions. These are my disclosures. So we've all heard in this session,
and then in the one before, that treating lesions in zone two and zone one is particularly challenging when you're going to land in zone zero. And it doesn't matter whether you fix these things open, whether you do arch debranching,
or one of the specially designed grafts. There's a risk of stroke, paraplegia, and death, which is what we've heard. None of these grafts are approved, either in Canada or the United States. But let me introduce you
to the Nexus Single Branch Arch Graft. Here it is, a modular design, it's made of Nitinol, it's 20 French, there's a single branch here for the innominate, an opening for the arch module, and then this part, which goes into the
mid-arch and the descending thoracic aorta. You can see the ascending module, which fits in and locks on this tantalum ring, and is placed in the ascending aorta. Obviously this is done with rapid ventricular pacing. This system minimizes brain and limb ischemia.
There's very much reduced arch manipulation because you're not cannulating branches. But it does require arch debranching with a carotid-carotid and a carotid-subclavian bypass. This device is pulled up on a through-and-through wire from the brachial artery, which I'm going to show you.
This system has been used in 28 patients. First in man study, in 11 patients, and a compassionate use in 17, which is where our cases fit in in Toronto, and these are the people who've implanted them. This is an example of one of our initial cases,
two saccular aneurysms, one in the descending thoracic aorta, which was fixed initially, and then we came and fixed the arch aneurysm using the Nexus system. You can see that with a through-and-through wire through the brachial down to the femoral,
we've placed the device. We do an angiogram to mark the carotid and subclavian bifurcation, and then the device is beginning to be deployed here. Once you get the initial part of the branch deployed, it's advanced slightly, so that you can open
the opening for the arch, for the ascending aorta, and then the ascending module is then deployed with careful markers that allow you to deploy this right on this tantalum ring. You can see the final result here, with perfusion of the carotid-carotid, carotid-subclavian
in the 3D rendition. Now our Toronto results, you can see that our patients were relatively elderly, they were 75. They had large aneurysms, almost seven centimeters. The distance from the innominate to the origin of the aneurysm,
one is an average, just about one centimeter. And there was a significant length of stay associated with the debranch as well as the repair. Importantly, however, there were no strokes, no spinal cord ischemia, and no mortality. And we had no proximal endoleaks.
We did have one patient here, you can see, who had a hematoma in their ascending aorta, which evolved into a dissection, and that required removal of the ascending module with sewing a conventional surgical graft to the rest of the endograft.
There was a type III and a type II endoleak, as well. Now you've already heard that the results of doing this, whether it's through conventional surgery or through open repair, are associated with mortality. So if you look in the literature, you can see this systematic review
and the meta-analysis by Moulakakis, which shows results for open elephant trunks, arch hybrids, this is the most recent Cook publication, with their most recent series, and a systemic review from Piergiorgio Cao. Here are our results in the Global Nexus.
So there have been, with the Global Nexus, a 7% 30-day mortality, but we have not had any. But there is, that's very respectable compared to open elephant trunks at 9 1/2%, and almost 12% for hybrids. You can see that there's been a 7% stroke rate
with full recovery in the Global Nexus, but we had none. And there's 11% in the Cook and 6.2 in the open repair. There's been so spinal cord ischemia, but there has been some in the open and hybrid repairs. So in summary, Mr. Chairman, the Nexus Arch graft minimizes arch manipulation.
The favorable early results, I believe, with no strokes, is a result of this. This is applicable to arch aneurysms, with and without dissection, and clearly larger case series are going to define its role in the longterm.
- [Presenter] Thank you very much. This is Jordan. It's my pleasure to share this panel with endoanchors believers, I'm one of them. So, there's my disclosures. The scope of the problem about the proximal migration starts
in order to think about the durability of thoracic endografting, because it still is a concern. The cranial migration from the distal attachment is part of this particular concern, especially when the distal neck length is less than three centimeter.
I think this is a under-reported complication in these areas. That is, what has happened, after some kind of follow-up, after four years follow-up, the distal part of the aorta, or the distal part of the endograft is dis-attached from the primary landing zone.
Because all the forces in the ascending thoracic aorta acting in the up cranial fashion. So when you are virtually sure there some kind of migration rate of two years but also have some kind of cranial migration from the distal part of the aorta at the one year is 1.2%
for the VALOR trial and 1% in one year also for the TX2 trial. In our experience, before 2006, for distal neck length, between 1.5 to 3 centimeter in length, 60% of cranial migration rate was registered at five years follow-up. So what's a lot of percent about that we try to perform
a different kind of approach for those particular short or no short, nice distal neck of thoracic aorta. So cranial migration as previously mentioned is under-reported. The upside for the abdominal aorta with the forces acting in the downstream anteriorly in the thoracic one is
posteriorly a cranial and also a cranial migration course. And this kind of phenomenon kind of course in the long run follow-up. These connections and also cranial migration. About the preventative actions there are different kind of creative alternative in order to prevent that,
but let me to focalize my attention and your attention to endoanchors philosophy that is part of our current approach. For a regular neck of more than three centimeters we can use regular endograft but sometimes when it's not so regular it's not so straight, we prefer to use in combination
with endoanchors. When you have a regular straight but between 1.5 and 3 centimeter we prefer to use distal scalloped endograft plus endoanchors as you cam see here. That is what the speakers talk about very extensively but this is just a case in order to see
what happened after two years follow-up in this lady when it has this distal type one endolink we apply the endoanchors and after three years the endoanchors remain in the same position, as you can see here, without any kind of further complications.
So another example, in combination with scalloped devices, scalloped thoracic endograft, just in order to be sure, that the movement in the distal part doesn't occur or even weaken over time. For sure, when you have very short neck length,
that means less than 1.5 centimeter, then we need to switch to another kind of solution like this fenestrated or branched endograft, like you can see here in this example. So in summary, the durability of thoracic endografting remains a concern when cranial migration is a consequence
of biomechanical forces of the thoracic aorta and it is under-reported. The proximal and distal necks deserve equal attention. And many different approaches have been suggested to avoid cranial migration. And endoanchors in combination with the scalloped,
fenestrations and branched endografts should be applied more often. Thank you very much.
- 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.
- 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.
- 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.
- [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.
- [Doctor] Thank you, Frank. Thank you Doctor Arielle. This sounds a little strange, it is strange and this is my disclosure. Medical treatment of Claudication includes, suppression of tobacco, supervised exercise, Cilostazol and control of risk factors. But, sometimes that failed and we made a couple
of observations, that I have to give credit to my partner, Doctor Fernandez, who did most of the work and the observations. This was a female patient, 84 years old. Sever COPD, who came with a complaint of 10 step Claudication, intestinal angina
and she had a high Creatine and renal insufficiency. She happened to have a coral reef aorta with occlusion of the aorta at the level of the diaphragm. So, she was not a surgical candidate. She was obese, sever COPD. So, we decided to do an Ax-bifem bypass. The Distal aorta and the iliacs were almost normal
as, usually occurs when you have a complete Occlusion. So, the Ax-bifem improved dramatically, the condition of the patient ,even the Creatine dropped. So, she went home very happy and after three months, she called me and she was having the same symptoms again. So I thought that the Bypass was occluded, but it was not.
She told me, that she was having Diarrhea for the last five days. We admitted her, hydrated her and amazingly, the following day, she was having breakfast without any pain. And I took her to walk and she had no Claudication. The second patient, was a 57 year old patient,
who had several operations because of an occluded Popliteal aneurism. All of them failed. We were called to do an amputation. The patient had a pale, right foot and cold, with no distal run-off. But, my partner decided to try the same thing
we did with the old lady and amazingly, in less than 48 hours, the foot was pink and warm. We decide to... because the common factor in both patients, we made the observation, was Dehydration. We decided to do a perspective study. The protocol was really simple, patients who failed after
the medical treatment for disabling Claudication or Rest Pain or even Ulcers, were included. The exclusion criteria took, that patients that had the, past history of Congestive Heart Failure or renal insufficiency, were excluded.
But the other patients were included. What we did with these patients is, to do a treadmill with time and distance to Claudication. Ankle/brachial pressures. Skin temperature and the, the only treatment we gave, was three liters of water a day. We had these studies before and after six weeks,
we repeated this studies. We sent all the information to an independent group, to be analyzed. The results. Those results were amazing, because the temperature increased significantly, but what increased the most significantly,
was the time and distance to Claudication and also the Ankle/brachial pressure and was a significantly decrease in pain sensation. This is a Cutaneous Temperature in the Dorsal aspect, in the Plantar aspect. And this is the distance to Claudication, using
a treadmill 3.5 miles per hour, at 10 degrees. You can see that is highly significant at P point zero zero zero one. This is the time to Claudication. Really significant change and this was seen in a ... We included 36 patients. Only one patient didn't comply
with the indication of (mumble). That one was the only patient who didn't have any change. Dehydration is common in elderly patients. Can occur because, fluid losses or decreased intake. Elderly people drink less fluids, because the sensation of thirst decreases.
The body water composition from 60 to 50, because of increased muscles, decrease in muscles and increase in fatty tissue, renal function is impair with less capacity to concentrate, increasing urinary, urine formation.Kidneys are also less reactive to the ADH
and have a lower ability to regulate Sodium excretion. Lastly, iatrogenic factor can aggravate dehydration. Laxatives, diuretics or angiotensin converting enzyme convertors. Level of albumin, also was a very important finding. In most of them, were less than three grams.
Conclusions. Most of elderly patients with intermittent Claudication were drinking a low volume of water, Medial 1000cc's. All patients who complied with the protocol, responded to an increase of water intake. Different in the pain sensation, ankle/brachial index
and distance of time, and time to Claudication, comparing before treatment and after treatment, were statistically significant. In the last six, seven months our cases of Angioplasty and Stenting, dropped almost 90% and the, the second patient, the one who was ready for
an amputation. They sent us a picture. He was in Mendoza, the province that is producing most of the wine. That day, he walked four kilometers, without any pain. For us, this was surprise, but it's so simple and so cheap, that should be applied. Should've been included in
the (mumble) of every Vascular Surgeon. Thank you
- Thank you, Mr. Chairman. Thank you, Dr. Veith for inviting again to this great meeting. It's my disclosures. Well, as we know and heard this meeting, there are some certain limitations of current EVAR (mumbles) anatomical procedure and economical reasons,
and I would like to present a relatively new device which may address current EVAR limitations with a simple low profile system, and basically, ALTURA consists of two parallel stent graft systems. ZEUS No Gate Cannulation is needed and unique features include D-shaped proximal stents
and suprarenal fixation. Multi-purpose (mumbles) possibilities as well, and the system of utilize 14 French delivery system. And as aortic components can be deployed offset to accommodate the offset renals, and then the limbs are also unique
because they're deployed retrograde from distal proximally, and this allows precise positioning, both proximally and distally. Well, as the ALTURA clinical experience includes the very first human implants as well as more recent case performed
with a fully commercial device, and a total of 90 patients with a AAA were enrolled between 2011 and 2015, and follow-ups are taken at 30 days, six months, and annually to five years, and this presentation gives a current status of follow-up, and our results with a 12-month follow-up were published earlier this year.
Our clinical data were collected in total of in 11 sites. It includes 90 patients. And you see here, the patient demographics and anatomy do a typical, which are typical for all EVAR patients and the mean follow-up was 2.7 years. And procedure of success was 99%.
Only one patient, one of the first patient was Gen1 was not implanted, and 50% patients were done percutaneously, and majority of them underwent regional or local anesthesia. So when you look into the results, we see that there was only one case of AAA ruptured,
which occurred at three years due to type II endoleak and sac enlargement as the patient, which refused treatment due to type II endoleak. And all other deaths are paired to no original causes, and two patients had device migration at two years. The same patients appear at three-year period,
and basically these were undersized grafts was sort of our learning curve, and there was no any migration later on. Four patients had type I endoleaks visible on CT, and read by independent committee between 30 days and one year.
None have required secondary treatment and have been no aneurysm enlargement observed. And at one year, not surprisingly for this kind of devices, there was 17% type to endoleaks, but only one patient required secondary procedure due significant sac expansion.
Well, wasn't, of course, what we saw, I expected majority of patients has had shrinkage. There was a four-year period. And this is a patient who was recorded with the type IA endoleak at 30 days, caused by the last calcified nodule,
as you he's here probably none of the other device would tolerate that, but the endoleak did not extended into into the sac and had a leak result spontaneously without sac enlargement through a four-year follow-up period, as we're seeing here. Well, here another patient with type IB endoleak,
due to (mumbles) generation was treated with coils and glue an extension with additional stent graft to external iliac artery. What's interesting was the device. Device can tolerate small distal aortas and five patients who were treated
with small distal aortas and the very first patient was not dilated enough and stents were not deployed, simultaneously causing some stenosis which was easily treated with PTA afterwards, so we learned but it's very great, unique feature to treat the small distal aortas for the device.
And of course, sensing what happening with them, septal endoleaks, because everybody being concerned what happening with that, and nevertheless, there were no septal endoleaks observed during the follow-up period. In conclusion, Mr. Chairman, ladies and gentlemen,
I would like to say this Novel Altura endograft concept has potential to play major role in mainstream EVAR cases and potential benefits include predictability, reposition ability to place the device very, very, very precisely, offset renals, to maximize use of the neck, and low profile
overcomes current and anatomic limitations like tortuous iliacs, narrow bifurcation or access vessels and no limbic inhalation is needed, and basically, I truly believe that this offers option for EVAR day surgery and ruptured aneurysms. Of course, first results are very encouraging.
We need more data. Thank you very much.
- 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.
- So this talk is similar to Professor Vermossin in that we're trying to establish again the idea that EVAR is really the choice of treatment here, especially for patients who can't undergo an Open Repair. I have no disclosures. So why does this even come up? Well, as we know the DREAM trial very nicely elegantly
show that early on there was a mortality benefit of EVAR over Open Repair, but out to two years that mortality benefit was lost and the curves began to meet and equilibrate. And when you look at the EVAR 1 study, when you get out to eight years,
those curves actually invert and the all cause mortality for Open Repair was actually beneficial as compared to EVAR. And so it becomes a question, based on somebody's RCT or whether or not Open Repair is really the better way to go. But at least for this discussion we're talking about
a select group of patients. Those patients who are unfit for Open Repair. Multiple comorbidities, high frailty index. Totally different population than the overall cohort. And so when you go back to EVAR 1 and you look at it, these patients, these frail patients,
lot of comorbidities. They're the ones who would exactly benefit from that early aneurysm or early all cause mortality benefit from EVAR, 'cause these are the patients that may not life to meet that eight year crossover point.
In addition, there's been a lot of temporal changes in terms of EVAR. There's evolving technology and there's evolving techniques. The devices are lower profile. They have better durability.
It's easier and more precise in terms of delivery and implantation for these devices as well now. Moreover the techniques have evolved significantly. We're doing almost all these percutaneously. There's very rarely a situation where you need to cut down. The procedures are done very quickly now.
A lot of them are done in less than an hour. And there's avoidance at least of major pitfalls, I mean, the last time I've heard about an iliac artery disruption was probably five or six years ago. This type of large complication rarely occurs anymore. And this study from the Mayo Clinic corroborates this.
When they look at their series of patients who had Open Repair and EVAR, the top graph is basically those patients who were treated from 2006 or earlier. The bottom graph is the patients treated from 2005 or later. And you can see the mortality benefit from Open Repair basically disappears in the lower graph
and that cohort that's treated later. Again, kind of corroborating that techniques and devices have changed, improving EVAR's survivability. And this paper looks at the NSQIP database and says basically the same thing. That contemporary 30 day mortality after EVAR
in high risk patients is substantially lower than that reported in EVAR 2 trial. So gain, demonstrating and showing a picture of EVAR with better survivability and the data that's come out from these earlier trials in terms of EVAR mortality is not necessarily translatable to current day.
So, what we are expecting for EVAR? Well, I think really, two things. You want prevention of death from the aneurism and you want a quality of life. I mean, quality of life is important. These patients come in and expect to be able
to be back on their feet shortly after the procedure. And when you look at the EVAR 2 long term survival, aneurism related mortality is improved over Open Repair out to 12 years. And then when you look at the improved data, the quality of life was significantly better
for EVAR versus that of Open Repair. But I wanted to just kind of get you to shift and look at it from a different perspective and not just see it from what EVAR is in terms of beneficial, how it's changed and how the survivability is improved.
But really what are the expectations in terms if Open Repair? What is the patient tolerance? What are the training and what are the volume paradigms in today's day and age? Well clearly, when you look at these two things
percutaneous, especially the access to the groin, is going to be infinitely better tolerated than an open incision, whether it be transperitoneal or retroperitoneal. So clearly there's a benefit of EVAR in terms of that. But more importantly, we know that the,
historically we've shown that high volume centers and high volume surgeons have better results for Open Repair. And without question, the more you do, the better you're going to get at it. And so, when you look at that in conjunction
with these types of data where clearly the numbers of Open Repair through the country are reducing dramatically and continue to decline. We looked at this and this was a slide of EVAR, which was the positive slope, and Open Repair, which is a negative slope,
in terms of trainees graduating. And that ended in 2010. That slope continued to be negative. When you put those two together, you realize that people are coming out with less and less Open training.
Their experience with Open Repair is only declining and when you contrast that with EVAR, which is improving technology and techniques, it becomes obvious that in certain circumstances I think the randomized control data can no longer be looked at and you have really just think about
EVAR as the best treatment for these patients. Thank you.
- (Speaker) Thank you very much So we're going to try to tackle all of these issues. I do have some disclosures. The indigo system that we're going to talk about does have FDA approval in the vascular system. It is contraindicated for neurovascular and coronary use although there are specific catheters made by this company
for use in those areas, so we're going to talk about the use strictly in the periphery. So we know that Acute Limb Ischemia requires revascularization and we use this Power Aspiration system, we call it XTRACT, using the Indigo system for a number of different therapeutic options.
The device we're talking about, these are reinforced catheters so there's no collapsing of the tip during aspiration. They're atraumatic, this technology was developed and really pirated in some way from stroke work, where we were putting these catheters in the
middle cerebral artery, so these catheters track, it's exceptionally rare to see any vessel damage. We have not dissected any vessels in over 120 cases. The catheters are hooked up to direct tubing to a small handheld pump,
which is easy to use, which sucks, an essentially true vacuum, so that you get maximal aspiration. And, they come in different sizes: 3, 5, 6, and 8 French and you can see there's a large increase in aspiration power as we go up
in size. So this would be a typical case where we have an SFA occlusion, in the distal SFA. There's also a TP trunk occlusion. There's an anterior tib. which is a stump distally. And we don't see any real flow below the TP trunk.
Here we can take a CAT6, we place it in the clot. It's very simple to use. The learning curve here is extremely low. You turn the vacuum on, you just be patient and wait. You don't run this through the clot, and if you suck this way and be patient,
embolization is extremely rare, and I'll show you some of that data. We clean that up as I showed you, then we advance down into this tibioperoneal trunk, and after two or three minutes of aspiration with some gentle catheter moving,
we're able to clear up the TP trunk, we can come back and balloon the underlying lesions and leave this patient who had no runoff, essentially with two vessel runoff. In Press right now, we're actually online, published, and in print, are the results of the PRISM trial,
which is using this system as a retrospective registry, and this is used in 79 patients after failed thrombolysis, as a primary device for acute limb ischemia, for distal emboli caused by other interventional procedures such as angioplasty stem placement.
We looked at patients who had little flow or no flow, TIMI 0-1, and basically we evaluated the flow before. We use this system after we use the system and after any other adjunctive intervention. And along the bottom you can see that we restored flow,
excellent flow, TIMI 2 or 3 flow, and 87% percent of the patients, after the final intervention, so treating the underlying lesion, 96% of patients had essentially normal flow. So, 87% as I say success
just with the device alone, and then using adjunct devices. There were no serious adverse events. The complications from this include vasospasm. We did not have any vessel dissections, or vascular injuries, and
no serious event directly related to the catheter. So where do we use this? Well, we can use this as I mentioned for acute limb ischemia. We can use it as a primary therapy for embolic occlusions. We can use it after iatrogenic emboli.
We use it after incomplete thrombolysis when there's residual clot, so we don't have to lyse someone up further. We can save lysis time and money overnight. And we've expanded our uses out of the arterial and now we're looking at venous, pulmonary, mesenteric,
and dialysis applications. We just published our results in the pulmonary circulation from the single center. There's a retrospective study that's been completed, and now a prospective study which we're just beginning right now.
We actually have our first sites up and ready. We've had experience with DVT, and we're also using this in the mesenteric and portal circulation. A quick image of a before and after on a pulmonary embolism. There's an extensive mass of patient who came in with profound hypotension,
post-using the XTRACT system. So the benefits, simple and easy to use, highly trackable. Limitations, blood loss if you don't know how to use this right. You just can't run this vacuum in flowing blood. Once you learn that and control the switch
blood loss can be minimized. As I mentioned, the learning curve is small. A few tips, not to use the separator much in the arterial system. Just be patient with your suction. Be careful damaging the tip when you introduce it
through the sheath, there's an introducer. In conclusion, we think this is an effective method to primarily treat arterial occlusions, venous pulmonary occlusions, and more data will be coming to you on the venous and pulmonary sides but I think in the arterial side,
we actually have several publications out, demonstrating safety and ethicacy. Thank you.
are in the room here's a case of an 80
year old with a previous mi had a left hand are directing me and it's gonna go for a coronary bypass graft but they want this carotid stenting significant card accenting lesion to be treated first there's the non-invasive blow
through this but there's the lesion had a prior carotid endarterectomy so had that surgery we talked about first but at the proximal and distal ends of that patch has now a stone osis from the surgical fix that's developed so we
don't want to go back in surgically that's a high resolution we want for a transfer Merle approach and from there here's what it looks like an geographically mimics what we saw on the CT scan you can see the the marker and
the external carotid artery on the right that's the distal balloon and then proximally in the common carotid artery and they're noted there and then when you inflate the balloons you can see them inflated in the second image in the
non DSA image that's the external carotid room carotid artery balloon that's very proximal the common carotid balloon is below or obscured by the shoulders and ultimately when you inflate the common carotid balloon you
just have stagnant blood flow then we treat them you can see both balloons now and the external carotid and common carotid in place we have our angioplasty balloon across the lesion and then ultimately a stent and this is what it
looked like before this is what it looks like after and tolerated this quite well and we never had risk of putting the patient for dis Lombok protection or to salamba lusts overall I'm not gonna go over this real
- [Dr. Vikram Kashyap] Thanks to Dr. Viets for the kind invitiation. Dr. Hotze and Dr. Calgoro, and thank you Dr. Escobar for that great introduction. Obviously, percutaneous mechanical thrombectomy's something that we all use. It hastens treatment, and we use it regularly
for both venous and arterial thrombosis. However, PMT has been linked to cases of reversible post-operative acute kidney injury. It's thought to be due to either the hemolysis and the deposition of red corpuscle elements into the kidney parenchyma, and it may actually also
potentiate contrast-induced nephrotoxicity. Clearly, PMT leads to mechanical breakdown, but the intravascular hemolysis is perhaps the concern. And as Dr. Escobar illuminated, clearly can reduce the time for catheter-directed thrombolysis
or overall thrombectomy, period. Catheter-directed thrombolysis on the other hand, chemical breakdown through, usually, the plasminogen system, with converting to plasma, and then fibrinolysis. But clearly, because of the risk of bleeding, we think about using PMT to decrease the CDT time.
Our hypothesis was that there is an increased incidence of renal dysfunction in patients undergoing PMT for treatment of an acute thrombus, compared to patients undergoing CDT alone. So this is a report- a single-center, retrospective study. 227 patients were reviewed.
145 patients were included into the study analysis. The excluded patients included patients that had acute kidney injury before their intervention, patients that were already end-stage renal patients on dialysis, and patients who that either inadequate or no follow-up data.
So of those 145-odd patients, one-third had arterial thrombosis, two-thirds had venous thrombosis, and as you can see in this pie graph, about half the patients had combination catheter directed thrombolysis
and percutaneous mechanical thrombectomy. 12 percent had CDT alone. 10 percent had PMT alone. And then 29 percent had PMT with pulse spray tPA in a single-setting intervention. We used the RIFLE Criteria to characterize
the severity of renal dysfunction after intervention. And in the RIFLE Criteria, you can see in these rows risk, injury, and failure. There's an increase in creatinine or a decrement in GFR and Loss and ESRD are obviously patients that go on to either temporary or permanent dialysis.
This was the incidence of renal dysfunction in this group. 20 percent in the patients that had PMT alone. With power pulse PMT TPA - 21 percent. With the combination PMT and catheter-directed thrombolysis - 14 percent. And with catheter-directed thrombolysis alone - zero percent
These were highly significantly different between these two groups and the CDT group with values as you can see here on the lower right. If we look at the RIFLE Criteria, none of these patients went on to permanent dialysis. They all had risk, injury, or failure,
which were decrements in GFR, or escalations in creatinine. In fact, all the patients were covered to their baseline renal function, but it took an average of 5.1 days. This lengthened their hospitalization. And all 22 patients that had renal dysfunction
had either PMT alone or PMT combination therapy. If you look at the procedural of variables in this table, you can see that the length of admission's actually fairly similar. Importantly, the total TPA dose was similar, and the total contrast volume
between these two groups was also similar. If you look at other post-procedure outcomes, luckily, none of these patients that had renal dysfunction had long-term harm. There was similar six month mortality, six percent versus five percent.
Other complications were very similar. Limb salvage was 92 and 95 percent and there was no increased readmission rate for DVT or arterial thrombosis. So, ladies and gentlemen, in conclusion, the use of PMT as a treatment for venous
or arterial thrombosis is associated with acute renal dysfunction, but is not associated with adverse six month clinical outcomes. We still use this to hasten thrombolysis time and decrease time in the hospital,
but I think it necessitates that we have post-operative, post-procedure vigilance, and renal protective measures as much as possible to decrease the likelihood of renal dysfunction. Thank you very much.
- 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.
- Thanks Stephan, yes I just want to give you five tips and tricks that I've learnt with my experience to this technique, and also then I'll present some results from the Ascend International Trials. I have an obvious disclosure that is important to show.
So, I do think that custom-made devices or phenostate graphs are the gold standard in this area of the difficult neck to aneurysm, but there are constraints with it, both financially and atomically, and of course its not the perfect solution
so we still need to strive to find better solutions for patients and indeed an off the shelf solution is very useful especially in emergency situations. I think we're all quite surprised by the outcomes from parallel grafts.
I certainly, when I saw this originally thought this was never going to work but actually, the results from standard evar with chimneys are really quite good. There is however always the potential for gutter endoleaks when aligning
parallel grafts with conventional EVAR stents which are not really designed for this purpose. So, endovascular sealing with parallel grafts offers a solution to this with the prevention potentially of gutter endoleaks because the polymus bag will seal alongside
the parallel grafts. And in practice this works quite well so you can position two, three or even four parallel grafts alongside the nellix sealing device to give yourself a really good seal and an example is shown here on the CT.
So tips for getting good outcomes from this, well the first is an obvious one, but its to plan very carefully, so do think you need to be very cautious in your planning of these with regard to multiple levels of the technique
including access, the type, length, and the nature of the parallel grafts you're going to use. I'll talk a bit more about the neck lengths but aneurysm lengths as well because there are some restraints with the
nellix device in this regard. You need to take very carefully about seal both proximally and distally and I do think you need to do this in a hybrid theater with experienced operators. I mentioned neck lengths and my Tip two is
you have to not compromise on neck quality and neck length. So you need straight healthy aorta of at least 15mm, of less than 30 diameter and a low thrombus burden. If you do compromise you'll see situations as the one on the photograph shows
where you get migration stents so you must not compromise on the quality and length of your aortic neck and if that means doing more chimneys, do it that's not a major problem but if you compromise on neck,
you will have problems. I mentioned the parallel grafts, again this is part of the planning but we use balloon expandable stents of a reasonable length to ensure that you get at least a centimeter into each of the branches
and you have to be careful to position these above the polymer bags so that they don't become constrained by the polymer bags from the nellix device. You have to be very careful when positioning these so the tip four is watch the parallax in
two different angles to be sure, as in the case here, that you line up all your stents appropriately and that you don't get crushing of any of the individual stents. So parallax is vital. And th
ltiple levels of redundancy in the nellix system which you can use to your advantage to ensure you get a good seal. So here's an example where the bags you can see are not entirely filled using the primary fill.
And it is quite difficult because often you get polymer pressures that are slightly erroneous in the endo bags. So use the redundancy including what's called the secondary fill of these bags so you can adequately fill the bags
right up into the aortic neck and ensure a very good proximal seal. So what are the results, well this is the post-market registry of Ch-EVAS this is an open-label study with no screening and I'll just show you a few slides of the data
on 154 de-novo procedures, which are a combination of single, double triple, and even quadruple chimneys. And if we look firstly at outcomes at 30 days the outcomes are good, that you'd expect in these difficult anatomies,
so 2.6% mortality and stroke, and just two cases of temporary renal failure. And if we look out 12 months, the freedom from aneurysm related and all cause mortality is favorable and comparable with any of the other endovascular techniques
in these difficult anatomies, in the upper 90 percents. And endoleak rates, you pretty much eradicate type two and type three endoleaks, but remember this is only 12 months, and very low levels of type one endoleak
and its really the type one endoleaks that are difficult to fix and if you ensure that proximal neck is adequate this shouldn't occur. And finally just secondary interventions, again this is out 12 months. Secondary Interventions are low and again
I think with the tips that I've shown you, you can reduce this to an absolute minimum. So this does offer an off the shelf alternative I don't think in any way this is to match the current gold standard which to me is the custom-made devices, but it's a very useful
adjunct to the techniques we have, and again provides that off the shelf solution which in emergencies and urgent cases is essential. Don't compromise on your neck, the outcomes I think, in this group are promising, but of course, the long term durability is
absolutely essential so it's important we follow these patients out to at least 5 years. 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.
- [Instructor] Thank you very much. So, you saw some of the issues that our, oh, this is the slightest cut, but that's okay. Some of the issues that we've seen with these percutaneous mechanical devices, and, back in the 90's, and perhaps even more than a decade ago, there were a lot of these.
And this space gets hot and cold, and one of the problems is that the level of evidence for doing these is very low, and when it is done, it wasn't done well. And this is a nice registry, a lot of patients enrolled, unfortunately we didn't learn
what we had to learn from these types of registries, because of just the study wasn't done well. So the level of evidence is low, and when we did have them, they didn't really work. And you saw some of the problems, that these devices can cause.
And here's another problem that wasn't discussed. You can see the DVT, iliofemoral DVT in here, and a device is pushed a few times up and down, and sort of aspiration, a Bertoulli, that type of thing. And this looks, oh wow, well this looks good,
maybe the thing is working, except all the clot is up here. So, these devices tend to push the clot around. So the issue is, enter now more recently, these are some of the more recent ones. Note that the AngioVac is not here, I don't consider that a practical thrombectomy device,
and so, it's not here. So, we're going to be talking about JETi. This is a system that is an aspiration system with a jet that comes inside the catheter, therefore the clot is engaged and pulled in and broken down by the jet, therefore there's no hemolysis.
And this demonstrated in this case, which is acute and chronic 17 year old multiple DVTs in the past, the iliofemoral segments are stented, as you can see here, this segment is somewhat fresh clot but these, as you can see, are subacute clot. Look at this, so the system now is designed
for over the wire, but for DVT you can use it without the wire, because it works a lot better. As you can see it can really aspirate the clot, in before your eyes. Now this I have passed the device in here once, and you can see the fresh clot is gone,
we have some residual debris in there, we have not established flow yet, and then I turn the device on... and it pulls the whole thing in, okay? So, very powerful aspiration method. So, and as you can see here, we don't have
a flow establish, outflow established yet. Therefore, when you turn it on, you have a vacuum created right here, and so this tells you how strongly this device can aspirate and work. And this isn't on the table.
After a pass here, two passes here, some residual clot in here, obviously there's residual clot there. So we pass it around these areas once more, and this segment obviously needs to get stented and on the table, re-establish antegrade flow. Since May, we've had 19 patients treated, most of them DVT.
And, based on our assessment, 17 of the 19 patients at a total time of 90 minutes on the table, had better than 90% clot retrieve. We have 30-day patency data on only 16 of those patients, because this is really since this May. And 15 of those were open, one re-thrombosed
and we had to retrieve again. Conclusion, so preliminary experience indicates that this is an effective device. There were no safety issues, we don't see any hemolysis, we don't see any pushing around of the clot, but there is a learning curve to it,
and for best application, 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.
- Okay, thank you. We know that inflammatory AAA have quite low incidence. The main problem is related to the thickness of the aortic wall and to the retroperitoneal fibrosis that involves the organs that are close to the aorta. Open surgery is quite difficult for these reasons. And these imply a higher mortality rate
that is threefold the one for standard AAA. And the higher morbidity related to the surgical dissection in fibrosis with risk of iatrogenic injury of the involved organs. So that some authors suggest the supraceliac clamping. That of course have some other issues.
A recent paper suggests that a pre-op treatment with a cortical steroid therapy can be useful to reduce inflammatory signs and so minimize the operative risk for these patients. On the other hand, endovascular treatment has been proposed since 1997 with different outcomes.
Certainly mortality rate is lower when compared to open surgery, and even the one year mortality is lower. But we have a problem with periaortic fibrosis that does not decrease as well as with open surgery. And there is some progression, in some cases, with higher nephrosis that leads
to other types of complication. This is not a standard. You see in this paper that there is no problem with periaortic fibrosis after endovascular treatment. But in other papers, the situation is different. There is a worsening fibrosis and even the development
of fibrosis after standard EVAR in patients with no history of inflammatory AAA. And certainly the phenotype eg4 seems to be related to a worse outcome after EVAR. So, based on this situation, what we have done in the last year is to use a systemic steroid protocol
for our patients with inflammatory AAA that is the same that is used for arteritis and retroperitoneal fibrosis. And you see how impressive is the situation in this case. We had only four days of therapy, and we have a decrease in periaortic fibrosis of 28%.
We studied all our patients with PET/CT. We made a comparison with the patient with standard AAA, and we observed an increased level of captation that was really significant. This is our population. All of the patients had immunological screening,
and the evaluation of the inflammatory level. This is the operative situation. All the patients had a good result with no mortality at 30 days. Only one patient died three months later for other reasons. And what we observed is that in almost all cases,
the periaortic fibrosis reduced significantly with the, even with PET/CT. All the patients were asymptomatic. And all the patients with hydronephrosis have a release of the situation. You see that the diameter of the aorta decreased
of 9.76 millimeters, and there was a decrease in periaortic fibrosis of more or less one centimeters. So this is really significant, as you can see. And there was a reduce in the uptake for all the patients but one. We don't know exactly, he had a type two endoleak.
Don't know if this can be a correlation because it's a single patient. And another patient stopped corticosteroid therapy, and so there was a recurrence of this problem. The CRP reduced globally, but of course, it's not specific. So in some patients we had an increase for other reasons.
But our policy now is that we do EVAR, when feasible, associated to steroid therapy. That, in our practice, is effective. We use open surgery in patients unfit for standard EVAR, and probably, even for these patients, steroid therapy can be a choice.
- [Man] Yeah, thank you Kostas and thank you Professor Feith for the invitation. These are my disclosures. So there's big controversy here is is there a big problem with the Gutter Endoleaks after chimney, and coming back to the Pericles Registry was this
is the largest database we have at the time. We see a rate of eight percent at one endoleak immediately, but we only see 2.9 percent persistent type 1A endoleak after six month. And this is in a pretty large patient group, so I don't think so that we have a big problem,
but as always, if you have a complication for these 2.9 percent of patients, it's 100 percent and you have to deal with it. So here we see a typical Gutter Endoleak in an interesting case, a 87-year-old patient who got a single chimney for the
inferior mesenteric because of a colon resection in the past and we feared for colitis if we over-stent the IMA. And this is a control, and you see if there is not a big runoff vessel involved that these endoleaks disappear over time.
And so if you have an elective case, watchful waiting is a strategy to do because over 60 percent of these endoleaks will resolve. So you have a mandatory treatment indication if the patient has an urgent indication for symptomatic or ruptured AAA
you have to deal with it immediately. As we saw in the sessions before, predictors for persisting endoleaks are high flow lesions, multiple run-off vessels in the aneurysm. More than two chimneys and less than two centimeter neo-landing zone
created by the chimney technique. And what we also saw is if the patient has to take anticoagulation. If you have after three to six month persisting endoleak, you have to treat it, because its type 1A and the patient is not treated right.
So for the setting we put the C-arm from cranially we take an access form the arm. General anesthesia, because the embolization can take some time and, and the copolymer is creating some pain during injection. Don't forget to put your copolymer on
the shaker 30 minutes before you plan to use it. And then you need five to six french 90 centimeter sheath four to five french 100 centimeter j-tape glidecath or headhunter. An 014 wire and a 150 centimeter 014 microcatheter. And what is important is all materials
have to be complimentary in a telescope fashion. That your materials fit into each other. So here you see a case of a 77 year old patient with a persistent endoleak, due to a gutter on the back wall of the aorta. And this is certainly something you have to treat.
So we came from a brachial access here this is a headhunter catheter. you cannulate the gutter once you're in you have to confirm that you are really inside the aneurysm sac and not somewhere else, because this would be hazardous
if you embolize at the target vessel. And then in this case we put some coils to reduce flow in the lesion. You can even see that one of the coils went into one of the lumber arteries, draining the endoleak. And once you have put that cause you pull back
your catheter into the region of the neck and start embolizing with the coploymer. And it is important that you do that slow and that you stop putting the onyx in before you reach the upper rim of prothesis, so you don't have an overflow of the coplymer
and distal embolization that you do not want. once you have achieved this you do aspirate and take back your catheter. So here you see the post, post operative angiogram and you see nicely how the liquid embolization went around that
chimney stent and sealed that. And this is why we prefer liquid embolization, because this you can't achieve that with coiling material. Here you see the post operative control with a completely excluded, we prefer to do
MRA angiogram for the controls, because you don't have the artifacts that you will have if you use a onyx or coils. So let me conclude, go with a brachial access, don't do, harm yourself and do 180 degree turn treating these pathologies come from above.
Choose your materials well. You need an angled catheter to canulate between graft and aortic wall. You, check your catheter position before embolizing. Go slow, and go down with the frame rate to not to harm you and your patient
of the radiation, because if you slowly inject you just need one picture per second. And if its a high flow lesion put some coils so you reduce flow in the lesion and reduce amount of polymer you need. Thank you for your attention.
- [Dr. de Vries] Thank you for the kind introduction. These are my disclosures. It's why do endografts sometimes need additional fixation with EndoAnchors? Well first, patients with multiple hostile neck parameters still suffer a substantial risk for type I endoleak and endoleak related mortality.
The second reason is that our deployment accuracy of the endograft is not as good as we think. We reviewed 85 consecutive cases in our own hospital and we saw that mainly do the slope of the endograft in the aortic neck, we lose some important apposition,
especially in the outer curve. So the preoperative neck length is not the same as our post-EVAR seal. And the third reason is that some other techniques, like FEVAR do have their limitations and some people are declined because of the branch arteries.
There are also some physiological conditions which is are not good enough for FEVAR. And of course open surgery, well per definition is more invasive and also patients will sometimes have their aneurysm repaired by endovascular means. So EndoAnchors really creates the stability
of a surgical anastomosin shown by David Dietz, and it really rivals the migration resistant of a hand sewn anastomosis. Of the global Anchor registry is captured real-world usage of the EndoAnchors and nowadays 770 patients have been enrolled worldwide.
The Primary Arm represents the majority of the patients in the Anchor Registry, 437 patients in the patients in the Primary Arm. It's not exclusive the Anchor Registry for the Medtronic devices, but also the workhorses like Gore and the Zenith endograft.
Of the prophylactic arm, the patients treated without any endoleak it carries 314 patients in this data slide. And you can see that the majority of those patients will hostile neck parameters. It's true in 91 percentage of the patient cohort.
The median neck length is 11 plus millimeters and also conicity substantial in more than 40% of the cases. What about procedural success? It's high, it's almost 95%. You need an average of around 5.5 EndoAnchors and the time to implant those EndoAnchors is 15 minutes,
and of course there is a learning curve. Core Lab adjudicated outcome, the two years outcomes, there is no new type Ia endoleak in this cohort and no endograft migration. In the Kaplan-Meier Estimates, especially the freedom from
aneurysm related mortality is 98.4% and freedom from secondary procedures at two years timeframe is 92%. There are no serious adverse events related to the implantation of the EndoAnchors itself. No aneurysm rupture and the aneurysm-related mortality
is due to cardiopulmonary comorbidity and not due to aneurysm rupture itself. There's one patient with a surgical conversion in this cohort. And the short neck indication that are patients in the Primary, 70 patients,
only placed with an Endurant in combination with the EndoAnchors and in a prophylactic setting or a patients with a type Ia endoleak. But the median neck length is now less than seven millimeters, so really challenging necks
and also conicity is substantial. It's also a clinical challenging patients cohort. A lot of patients with notable comorbidities and what is important to mention, 17% are patients with symptomatic aneurysm and also one patient with a ruptured aneurysm.
And the well the main treatment is then for prophylactic use but also 21% of the patient do have type Ia endoleak. Procedural results are 31 minutes fluoro time, but only 17 minutes to implant the EndoAnchors. This is the one year outcome. I think it's excellent.
Only one patient with a type I endoleak and he needed a secondary intervention. We had two other patients with a secondary intervention but it was due to a false aneurysm in the groin and a distal extension. No conversion to open surgery and no ruptures.
What about the cost effectiveness? Well you have to consider, it's not only the device cost, but also the level of resource utilization, and also clinical outcomes. And when you compare the short neck cohort, here the 70 patients to the fenestrated IDE study,
there's a cost differential of more than 5,000 U.S. dollars in benefits of the use of the EndoAnchors in those short and hostiles necks. So we can conclude that the Endurant stent graft in combination with the EndoAnchors for short neck indication is easy to use.
It's an off the shelf solution. It gives greater flexibility versus the alternatives. There is no need for renal arterial catheterization and it's really efficient. Thank you very much.
- One more soft swing, I guess, at EVAR-2 for the afternoon, but this one will be from a slightly different perspective. We'll look at it from a methodological standpoint rather than an analytical standpoint, which I do with some trepidation preceding Phil Goodney on the podium. As we've heard, endovascular techniques have revolutionized
the treatment of abdominal aortic aneurysm, and yet, the EVAR-2 trial published in 2010 provided Level I evidence regarding high-risk patients with abdominal aortic aneurysm. There is no survival advantage of EVAR over observation, as we've heard.
So let's unpack a little bit about what we mean by Level I evidence. Level I evidence consists of properly designed randomized controlled trials. They demonstrate the effect size of an intervention, and they're characterized by
strict inclusion/exclusion criteria, are resource intensive and can be difficult to replicate. Keep in mind that enrolled individuals are frequently younger, white, and affluent, receiving care at academic institutions, and clinical scenarios are heavily scripted.
The EVAR and EVAR-2 studies are examples of such trials. By contrast, Level II evidence, and the definition of this varies by region, consists of, for example, use of large administrative and clinical datasets to compare outcomes from different interventions. These are, to be sure, subject to selection bias
and limited granularity, but they're characterized by high power due to large numbers and external validity because they include real life patients in clinical scenarios. Examples of this type of evidence is found in the VQI, NSQIP, NCDB, SEER, and HCUP.
This study, which I'm grateful to have seen referenced in two prior talks, uses the ACS NSQIP database to look at mortality rates after EVAR in high-risk patients. And this is an example of Level II evidence. What we did was look at EVARs
that were performed between 2005 and 2013, and we used the EVAR-2 criteria to define a high-risk cohort and then examined 30-day post-operative outcomes. In that study, we found that the 30-day mortality for these high-risk patients following EVAR and our cohort was 1.9% compared to the EVAR-2 trial in which it was 7.3%.
And we concluded the contemporary mortality following EVAR is substantially lower even in the high-risk group than reported in the EVAR-2 trial. So how do we understand this? I think it's been unpacked a bit by two of the previous speakers,
but our interpretation was that, as I mentioned, randomized controlled trials and Level II evidence are not the same. So randomized controlled trials, again, include and exclude patients for analysis, use selected devices and do often include
a learning curve for new techniques, whereas the use of contemporary cohorts such as our study have an inclusive population, limited granularity, but allows for changing devices and expertise over time. So in conclusion, randomized controlled trials or so-called Level I evidence,
demonstrates effect sizes for new therapies, while large retrospective data analyses augment the findings for these therapies across contemporary practice patterns and devices. Intelligent integration of data across study types leads to improved care of patients
and preserves the role of critical thinking for surgeons. The key points that I would like you to take away are that endovascular techniques and their indications for use are obviously rapidly evolving, and thoughtful assessment of the literature allows surgeons to nimbly integrate evidence into practice.
The bottom line, our analysis of the current literature suggests we should not deny EVAR to high-risk patients. Thank you.
- [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.
- Well Mr. Chairman, dear friends, last year was here on the same stage for discussion of the results of the EVAR 1 trial and trying to tell you that the results of the EVAR 1 trial were no longer valid and this year I'll try to do the same for the EVAR 2 trial. The EVAR 2 trial was a randomized control trial
conducted in the UK in 33 centers with enrollment between 1999 and 2004. It was a randomized trial in which the patients were randomized between conservative treatment and open treatment and the common ground for the study was that these patients were unfit for open repair.
What is unfit for open repair in the EVAR 2 trial? Well the decision was made from three criteria. Cardiac reasons were the main reasons to consider patients as being unfit. Respiratory and renal reasons are the criteria that were used.
There have been several publications on this trial showing a design of the trial, the preliminary results, the final results in our recently last year, the very long results with this trial. And what are the results? Well as you can see here, it was a statistically
significant difference in aneurysm related mortality between the patients treated with EVAR and those treated conservatively but there was no difference in overall total mortality and this led us to the conclusion that indeed there was not really a place in those EVAR in those patients unfit for open repair.
However, we might look more closely to these results. The first thing in this trial is that almost 10% or more than 10% of the 197 patients that were randomized for EVAR actually did not receive the EVAR procedure because they died prior to the intervention and what was the reason for this?
Well the mean time between randomization and EVAR in this study was two months and in a quarter of the patients, it was even three months. The nine ruptures that occurred before the intervention had taken place. Actually it'd be more than half of
the aneurysm related mortality in this group. Another striking observation was that those patients that had no intervention, 1/3 of these actually were treated with EVAR in the followup period. And when we look at the results, whether it's observation-influenced results,
well you see when we perform a vertical analysis, the difference in aneurysm related mortality was even bigger and also there was a clear trend towards improved overall survival. Although this was not significant and therefore, the author still remains to the conclusion
that there was no place for EVAR in these patients. Looking again closer to the results and looking specifically at the patients with no intervention, already in 2009, there was more than half of these patients in this group actually were patients that already had EVAR.
And even worse, in 2015, of the 13 patients in this group that still survived, there was only one, yes only one, that did not have an EVAR procedure. So it's clear for me that only patients with EVAR actually survive.
Why are the results no longer valid either? Well this study was performed in 1999 up to 2004 and it's clear from further studies, just one example, that the results in the meantime have clearly improved from 1999 to 2004. While it wasn't the Stone Age for EVAR,
it was not more than Middle Ages. Plus mortality clearly improved with time and then when you look at the results of this trial, the 5.7% operated mortality in the EVAR group are actually at this moment no longer standard of care when you compare to these three other studies
which actually use the same criteria for considering patients that's unfit for open repair. Also we've got longer term survival. The mortality of 40% after, no, no, 60% after 40 as in 80% off of JVS can no longer be considered really as up to date results and probably the reason for that
is also the fact that medical treatment upstream in these optimal patients as only 40% statins. So are EVAR 2 results still valid? I think it's clear they are not. It's an old study with old devices. The mortality is not conform to actual standards.
Medical treatment was not optimal. The delay in treatment caused preventable deaths. More than 1/3 of the patients crossed over and the statistical analysis does not reflect the actual treatments of the patients. Does this mean that we should operate on all patients?
Well, maybe not. This is a very recent study published earlier this year in logical patients and you see that when some, certainly once several of the risk factors were considered being unfit patients were present, that results were indeed worse,
especially when there is renal insufficiency. The IR for the SVS guidelines correctly state that it is just to inform high risk patients over their risk status and their mortality score and then making an informed decision whether we should proceed with aneurysm repair or not.
It's my personal opinion though that clinical judgment is probably the most important factor in this decision making process. Thank you for your attention.
- Thank you friends who have invited me again. I have nothing to disclose. And we already have published that as far as the MFM could be assumed safe and effective for thoracoabdominal aneurysm when used according to the instruction for use at one, three, and four years. Now, the question I'm going to treat now,
is there a place for the MFM? Since 2008, there were more than 110 paper published and more than 3500 patient treated. 9 percent of which amongst the total of published papers relating the use of the MFM for aortic dissections. So, we went back to our first patients.
It was a 40 year old male Jehovah Witness that I operated in 2003 of Type A dissection and repair with the MFM in 2010 because he had 11 centimeter false aneurysm. Due to his dissection, this patient was last to follow up because he was taking care full time off of
his severe debilitated son. When we checked him, the aneurysm seven years later shrunk from 11 to 4 centimeters wide. And he's doing perfectly well. Then the first patient we treated seven years ago, same patient with Professor Chocron
Type A dissection dissection repair in 2006. Type B treated with MFM in 2010. We already published that at one year that the patient was doing fine. But now, at three and seven years, the patient was totally cured.
The left renal artery was perfused retrogradely by aspiration. That's a principle that has been described through the left iliac artery. So what's next? Next there was this registry
that has been published and out of 38 patients 12 months follow up, there were no paraplegia, no stroke, no renal impairment, and no visceral insult. And at 12 month the results looked superior
to INSTEAD, IRAD and ABSORB studies. This is the most important slide to us because when you look at the results of this registry, we had 2.6 percent mortality at 30 days versus 11 30 and 30.7 no paraplegia, no renal failure, and no stroke vessel
13 to 12.5. 33 and 34 and 13 and 11.8 percent. With a positive aortic remodeling occurring over time with diminishing the true lumen increasing the true lumen and increasing the false lumen.
And so the next time, the next step, was to design an international, multicenter, prospective, non-randomized study. To treat, to use the MFM, to treat the chronic type B aortic dissection. So out of 22 patients to date,
we had mainly type B and one type A with no dissection, no paraplegia, no stroke, no renal impairment, no loss of branch patency, no rupture, no device failure, with an increase in true lumen and decrease in false lumen that was true at discharge.
That was true at one, three, and six and 12 month. And in regards with the branch occluded from the parts or the branches were maintained patent at 12 and all along those studies. So, of course these results need to be confirmed in a larger series and at longer follow up,
yet the MFM seems to induce positive aortic remodeling, is able to keep all branches patent during follow-up, has been used safely in chronic, acute, and subacute type B and one type A dissection as well. When we think about type B dissection, it is not a benign disease.
It carries at 20 percent when it's complicated mortality by day 2 and 25 percent by day 30. 30 percent of aortic dissection are complicated, with only 50 percent survival in hospital. So, TEVAR induces positive aortic remodeling, but still causes a significant 30 day mortality,
paraplegia event, and renal failure and stroke. And the MFM has stabilized decreased the false lumen and increase the true lumen. Keeps all the branch patent, favorize positive aortic remodeling. So based on these data, ladies and gentleman,
we suggest that the MFM repair should be considered for patients with aortic dissection. 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.
- Good afternoon to everybody. Thank you very much, Linio and Frank, for the invitation to the great session. First, the main problem is to define who is a no-option CLI patient? So I want to use, this is a young male, with a long history of diabetes, on hemodialysis.
This is the baseline angio. As you can see, the big vessel are absolutely open. We have an open spot of femoral artery, popliteal artery, and then also below the knee vessel are quite open, and we can see that the blood is going very well to the distalis, but in the foot,
we have a disease of all the foot vessel, which is a calcific disease. You can see here, this is the plain x-ray. I think that the plain x-ray of the foot is one of the most important information that we can get on the patients.
For every patient, I want to have this plain x-ray. You can see the medial artery calcification spreading everywhere, dorsalis pedis artery is occluded. We have a small, thin, tortuous, tarsal artery giving some blood to the forefoot. Medial plantar artery is occluded.
The lateral plantar artery is occluded. We have no any clear identification of the metatarsal vessels. This is the forefoot of this patient, and the majority of this patient, with a long history of diabetes and on hemodialysis,
have this medial artery calcification spreading to the tiptoe, and the first toe is totally avascular. This is the reason why this patient developed critical limb ischemia. So who is a no-option CLI patient?
I think that today, a no-option CLI patient is a patient without a target foot vessels. Today, SAD is the most common cause of no-option CLI patient because the SAD is correlated to the age, to diabetes, and end-stage renal disease. We have an epidemic of all of these three vascular factors
in our societies. In the majority of the cases, SAD is actually associated with medial artery calcification, in at least 25% of CLI patients, but today, I think that we are close to 40% present some degree of SAD-MAC.
So in this patient, how to create and master the hybrid foot vein arterialization circuit. This is the patient. My friend, Andrea Casini, vascular surgeon, has done a bypass with the proximal anastomosis of the great saphena vein on the distal P3 segment
of popliteal artery, and here we have this (mumbles) to give him blood to the medial marginal vein. Now, these are very good images, but we must learn how to read these images first. This is an arterialization on the superficial dorsal system of the foot,
so we have an inflow represented from, by the great saphena vein, and an outflow represented fundamentally by the medial marginal vein. We have other collaterals in the superficial system. For example, this is an ancillary superficial vein, and we see a faint shadow of the small saphena vein.
Then we have the deep dorsal system. We have a connection here, a perforant vessel, because it perforates the fascia, and goes from the superficial vein system to the deep dorsalis vein system. Here we have the two anterior tibial veins,
and the dorsalis pedis veins. Then we have the plantar system, the deep plantar system. We have these two plantar veins, the medial plantar vein, these are the two lateral plantar veins, and the deep plantar arch, and the two posterior tibial veins.
Now we have the last system, vein system of the foot represented by the superficial plantar systems, the Lejar's sole, and you can see here, this network, a network without valves, very thin veins, in all of the superficial plantar sole. We have a lot of connection
between these four systems of the foot. This is, for example, the perforator that I have dilated to give blood not only on the superficial dorsal system, but also to the deep dorsal system. We have many collaterals. I have embolized, for example, the anterior,
proximal anterior tibial veins, in order to avoid a precautious still of blood at the ankle level. I have embolized these collaterals that are perforator coming from the superficial dorsal system to the deep plantar system,
and stilling blood precautiously, and here we have the forefoot cross, which is the main cross between the three system, the superficial dorsal, the deep dorsal, and the deep plantar. Now, we can see that the arterialization was able to fill all the forefoot vein system,
and this is very important. When we get the direct blood flow through this collateral to the Lejar's sole, we know that the arterialization can really function. So I asked to my foot surgeon to do a non-geography guided surgery, wait for swelling,
wait for arterialized network expansion, respect the arterialized circuit, respect the forefoot cross, because we think that after foot vein arterialization, the foot is still ischemic, the arterialized circulation has not the same function of the standard circulation.
We must use a tension-free surgery to avoid focal ischemia. This is the tension-free surgery. I know that a transmetatarsal amputation could have been maybe more structurally stable, but I prefer to use this minimal surgery, and the patient has a complete healing
in two months, in two months. Now, the main problem of foot vein arterialization is to understand why this arterialization functions. Now, I propose you two hypotheses. The first is the mechanical hypothesis. Arterial and hydrostatic pressure force vein valves
leading to progressive valve incompetence, distal vein recruitment, and finally, direct issue nutrition by reverse blood flow. In 1906, Alexis Carrel made some experiments on dog, connecting with an anastomosis, the common femoral artery with the common femoral vein,
and he observed that there was the need of three hours at least to force by blood pressure the valves of the vein. Final, he said that practically complete reversal of the circulation is established about three hours after the operation. I want to prepare you this patient.
Observe, this is the acute phase immediately after treatment of foot vein arterialization with some leaking of blood on this vein that I have dilated. Eight days later, three months later, observe this geometry. Are impressive in my opinion.
Can we think that this geometry of vein, pure veins, can feed tissues like a normal standard geometry of artery? When I see these images, I answer, yes, I believe it. I believe it because we know that the venular plexus have a very thin vessel wall like capillaries, so it's a way, when we see these images,
we can really think about a complete reversal blood flow or something that is able to get the tissues and to feed the tissues. The second hypothesis is a biological hypothesis. Vein wall shear stress promotes a global remodeling and/or neoangiogenesis of the vascular system of the foot,
creating a new distribution system, and it was in hypothesis proposed by Languar. This is a LimFlow procedure on a patient like the first one, completely calcified, and this is the evolution, baseline, acute result, 45 days, 90 days after transmetatarsal amputation.
Look at this, 90 days, three months after the LimFlow procedure, the percutaneous deep vein arterialization, and about two months after the transmetatarsal amputation. This is really impressive. Look at these images.
What type of geometry, this one. Look at the baseline angio, and now we have all this vessel connecting with the veins. I am injecting blood contrast dye, so here in the distal stent of the LimFlow procedure, so we have no any blood flow coming
from the previous diseased arteries. This is the patient some months later. This is another patient baseline. An arterialization and after the occlusion of this arterialization, you can see this new neoangiogenesis.
Our results in 36 patients. We're able to get a 69% of limb salvage at 10 months, and I think that in highly selected no-option CLI patient, foot vein arterialization can be the only solution to avoid major amputation. Thank you very much for your attention.
- [Man] Bert, what some magnificent imaging and congratulations. When, just so that I'm clear, I mean, I've done, been lucky enough to have done a couple of LimFlow cases, and we are performing valve, using a valve at the time to perform valvotomies.
Are you suggesting that the pressure alone is enough to do something for the valves of the foot or how extensive do you think valvotomy needs to be in these cases? - [Man] This is our major limit because our limb salvage was correlated to the patency of the bypass,
and our patency was very poor, and it was very poor because we have not the reverse antegrade valvulotome, which is a part of the LimFlow kit. It's not sold alone, so we used some artisanal ways, like high pressure inflation of an oversized balloon. This is very effective but you have a restenosis rate,
very high reocclusion, thrombosis, and every failure, precautious failure of the graft of the bypass was correlated to a major amputation. - [Man] Yeah, okay. Any other questions or comments? - [Man] Is there any difference in your opinion
between a (mumbles) a total percutaneous? - [Man] I think that a total percutaneous procedure is a procedure with a target, which is the posterior system, essentially, because very few cases were done on the anterior system and the anterior deep system, in my opinion, is not a good target for the arterialization
because it is the poorest system, base system of the foot. The hybrid procedure can be done on both, the superficial dorsal system and the deep system. Obviously, you must choose according to the imaging of the baseline imaging or the vein system. Every patient is very different,
so you need to choose the proper target, vein target, into the foot. - [Man] Good. - [Man] Yeah, Roberto, this is very exciting stuff, and Rico and Asher and I tried to do this with primitive valvular destruction back in the 90s.
We had some incredible successes, but we also had some very bad failures. Patients got big, very much edema, one got into heart failure, one actually died, we felt, because of the AV fistula, and so we stopped, but can you talk about the mode of failure.
The successes are brilliant, and I think you definitely have something. We had some good cases but we had, our failures were all with the patent graft, and did you, you said I thought that you only failed when the graft closed.
- [Man] I read all your paper regarding this before starting, so I know that it's not easy. First of all, the key problem either the selection of patient. One of the key factor is heart function. We selected only patient with good heart function,
and second, the procedure is not a single procedure, standalone procedure. We had to follow the patient for months. Healing needs months, maybe repeat intervention, so you need a patient with an acceptable life expectancy and acceptable quality of life expectancy,
and acceptable working capacity, a salvageable foot, so a patient that can really cope with you in this long process of healing. The selection is a key factor. - [Man] Second question, why didn't you use the LimFlow exclusively?
- [Man] Because the LimFlow procedure is very costly, obviously, and in Italy, it is not reimbursed absolutely. This is the main reason.
- 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.
- Thank you very much. I'd like to thank Dr. Veith for the opportunity to be here and give a quick smattering in four minutes and a quarter. I have no disclosures. So despite the well-documented benefits of straightforward catheter-directed thrombectomy, it remains slow. It can several days and we need speed.
So, devices for physical removal of clots, disruption of clot, large volume removal, and/or combinations of above have certainly been developed. So, with regards with physical removal, aspiration devices, the number of which we'll have several speakers following, the CAT series is by far the
best example of it, if you will. Suction device connected to a continuous pump. Unfortunately, if offers poor transition into the wire. You have to advance in bare. Particularly when you're doing arteries, this can be concerning.
As you advance the thing, you can't tell if the clot is actually removed or not removed, so sometimes you can push it forward. If you've ever used the device, you've seen this. And clogging requires the entire remov
and thus, and you have to put it back through the artery and start all over again. And the concept of continuous removal with a pump is good for suction, but unfortunately, you can remove up to 160 cc's with just 20 seconds of using the device, as it doesn't have a reperfusion system.
The Aspire Mechanical is sort of a low-tech version, a manual aspiration device, where you have a pump that you manually pump up to start negative pressure. You can advance the catheter. The nice thing, you can connect it to literally anything.
If you can get a catheter in there, you screw it in and away you go. You're less likely to have extreme blood loss. You're unable to adjust the suction, unfortunately. And it's not really clear if the suction is actually working or not working.
The pump is on, you know that. But if you pumped it two or three times, is it sucking or not sucking? There's no actual feedback. The AngioVac is the most powerful or large-volume aspiration system.
It's filtered through a veno-veno extracorporeal pump. You can get a big circuit in there. You can do vena cavas, you can do iliacs, it's great. But you have to set up this very complex system. You require, what I'm going to put here as massive sheaths. So if you ever think about doing this in arteries,
you really can't do it. You need a 24-french sheath to put the device in, and then you need at least an 18 or a 20 to put the volume back in. So unfortunately, for arteries, you're going to have to put a conduit in,
and you're going to have to advance it bare through an artery. The extracorporeal filter pump is very expensive and it's not reimbursed. A lot of institutions will either let you use it a few times until they realize how much it costs, and then you're only going to be reimbursed for a thrombectomy.
With regards with mechanical, the Arrow-Trerotola is probably the most powerful and classic mechanical clot disrupter. It's got a spinning cable that looks like this, the new version. And it can damage native vessels,
so it's designed only for grafts. However, it can also get entangled in wires and stents, so even though the black box warning says don't do it, it doesn't keep people from trying it and having multiple attempts. And this is something that we had to remove once
from a graft because it was all entangled in the wire, and it could neither be pushed in or pulled out. It causes embolic materials. It spins inside, and we've never really manned up or womanned up and looked at what happens to the lungs when we fracture all this stuff.
Combination systems, like the Angiojet, is nice 'cause it can shoot out TPA and spray out a saline and break things up. And also, it has a negative pressure, which causes Bernoulli effect to extract clot. The upside is that it removes soft clot
through small side holes. We love it. It's fast, it sprays saline. However, it can also damage vessel walls. At some point, we've read and/or done ruptured in a thin vessel.
And of course, there's a black box warning against pulmonary. But also, if you've ever used it in a cadaveric graft, you'll do it once, and then they'll come back a month later, and now you have this diffused aneurysmal destruction of your bypass.
It also causes hemolysis. Typically, if you look at a Foley catheter, this is what your urine starts with at the bottom and what your urine ends with at the end. And both my group and Dr. Kashyap, who will be following, have assumed that it may not be good for the kidney.
I'll let him continue with that. So in summary, be judicious when you're choosing your approach. Continue to consider the potential downsides of each product. Risk/benefit ratio based on the patient.
Patient has renal dysfunction, limited outflow, sheath size. Old school lysis may be the way to go. Just look at it and maybe you don't have to do a fancy device every time. Or, actually, go with an open thrombectomy.
Mechanical thrombectomy is thus not like a car. When you're looking at these different options and say, "Gosh. You know, maybe it is faster, but perhaps I should think about it." But if somebody offers you this, there's no conceivable downside.
I would go with it. Thank you very much.
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