- Good morning, I want to thank Professor Vitta for the privilege of presenting on behalf of my chief, Professor Francesco Speziale, the result from the EXTREME Trial on the use of the Ovation stent graft. We know that available guidelines recommend to perform EVAR in patient presenting at least a suitable
aortic neck length of >10mm, but in our experience death can be a debatable indication because it may be too restrictive, because we believe that some challenging necks could be effectively managed by EVAR. This is why when we published our experience 2014,
on the use of, on EVAR, on the use of different commercially available device on-label and off-label indication, we found no significant difference in immediate results between patient treated in and out IFU, and those satisfactory outcomes were maintained
during two years of follow-up. So, we pose ourself this question, if conventional endografts guarantee satisfactory results, could new devices further expand EVAR indication? And we reported our experience, single-center experience, that suggests that EVAR by Ovation stent-graph can be
performed with satisfactory immediate and mid-term outcomes in patient presenting severe challenging anatomies. So, moving from those promising experiences, we started a new multi-center registry, aiming to demonstrate the feasibility of EVAR by Ovation implantation in challenging anatomies.
So, the EXTREME trial was born, the expanding indication for treatment with standard EVAR in patient with challenging anatomies. And this is, as I said, a multi-center prospective evaluation experience. The objective of the registry was to report the 30-day and
12 month technical and clinical success with EVAR, using the Ovation Stend-Graft in patient out of IFU for treatment by common endograft. This is a prospective, consecutively-enrolling, non-randomized, multi-center post market registry, and we plan to enroll at least 60 patients.
We evaluated as clinical endpoints, the freedom from aneurysm-related mortality, aneurysm enlargement and aneurysm rupture. And the technical endpoint evaluate were the access-related vascular complications, technical success, and freedom from Type I and III endoleaks, migration,
conversion to open repair, and re-interventions. Between March 17 and March 18, better than expected, we enrolled 122 patients across 16 center in Italy and Spain. Demographics of our patient were the common demographic for aneurysm patients.
And I want to report some anatomical features in this group. Please note, the infrarenal diameter mean was 21, and the mean diameter at 13mm was 24, with a mean aortic neck length of 7.75mm. And all grafts were released accorded to Ovation IFU. 74 patients out of 122
presented an iliac access vessel of <7mm in diameter. The technical success reported was 98% with two type I endoleak at the end of the procedure, and 15 Type II endoleaks. The Type I endoleak were treated in the same procedure
by colis embolization, successfully, and at one month, we are no new Type Ia endoleaks, nine persistent Type II endoleaks, and two limb occlusion, requiring no correction. I want to thank my chief for the opportunity of presenting and, of course, all collaborators of this registry,
and I want to thank you for your attention, and invite you, on behalf of my chief, to join us in Rome next May. Thank you.
- Thank you for the opportunity to present this arch device. This is a two module arch device. The main model comes from the innominated to the descending thoracic aorta and has a large fenestration for the ascending model that is fixed with hooks and three centimeters overlapping with the main one.
The beginning fenestration for the left carotid artery was projected but was abandoned for technical issue. The delivery system is precurved, preshaped and this allows an easy positioning of the graft that runs on a through-and-through wire from the
brachial to the femoral axis and you see here how the graft, the main model is deployed with the blood that supported the supraortic vessels. The ascending model is deployed after under rapid pacing.
And this is the compilation angiogram. This is a case from our experience is 6.6 centimeters arch and descending aneurysm. This is the planning we had with the Gore Tag. at the bottom of the implantation and these are the measures.
The plan was a two-stage procedure. First the hemiarch the branching, and then the endovascular procedure. Here the main measure for the graph, the BCT origin, 21 millimeters, the BCT bifurcation, 20 millimeters,
length, 30 millimeters, and the distal landing zone was 35 millimeters. And these are the measures that we choose, because this is supposed to be an off-the-shelf device. Then the measure for the ascending, distal ascending, 35 millimeters,
proximal ascending, 36, length of the outer curve of 9 centimeters, on the inner curve of 5 centimeters, and the ascending model is precurved and we choose a length between the two I cited before. This is the implantation of the graft you see,
the graft in the BCT. Here, the angiography to visualize the bifurcation of the BCT, and the release of the first part of the graft in the BCT. Then the angiography to check the position. And the release of the graft by pushing the graft
to well open the fenestration for the ascending and the ascending model that is released under cardiac pacing. After the orientation of the beat marker. And finally, a kissing angioplasty and this is the completion and geography.
Generally we perform a percutaneous access at auxiliary level and we close it with a progolide checking the closure with sheet that comes from the groin to verify the good occlusion of the auxiliary artery. And this is the completion, the CT post-operative.
Okay. Seven arch aneurysm patients. These are the co-morbidities. We had only one minor stroke in the only patient we treated with the fenestration for the left carotid and symptomology regressed completely.
In the global study, we had 46 implantations, 37 single branch device in the BCT, 18 in the first in men, 19 compassionate. These are the co-morbidities and indications for treatment. All the procedures were successful.
All the patients survived the procedure. 10 patients had a periscope performed to perfuse the left auxiliary artery after a carotid to subclavian bypass instead of a hemiarch, the branching. The mean follow up for 25 patients is now 12 months.
Good technical success and patency. We had two cases of aneurysmal growth and nine re-interventions, mainly for type II and the leak for the LSA and from gutters. The capilomiar shows a survival of 88% at three years.
There were three non-disabling stroke and one major stroke during follow up, and three patients died for unrelated reasons. The re-intervention were mainly due to endo leak, so the first experience was quite good in our experience and thanks a lot.
- Mister Chairman, ladies and gentlemen. Good morning. I am excited to present some of the data on the new device here. These are my disclosure. There are opportunities to improve current TEVAR devices. One of that is to have a smaller device,
is a rapid deployment that is precise, and wider possibilities to have multiple size matrix to adapt to single patient anatomy. The Valiant device actually tried to meet all these unmet needs, and nowadays the Navion has been designed on the platform
of the Valiant Captivia device with a completely different solution. First of all, it's four French smaller than the Valiant Captivia, and now it's 18 French in outer diameter for the smallest sizes available.
The device has been redesigned with a shorter tip and longer length of the shaft to approach more proximal diseases, and the delivery system deploys the graft in one step that is very easy to accomplish and precise.
The fabric has been changed with nowadays the Navion having the multi-filament weave of the Endurant that already demonstrates conformability, flexibility, and long-term durability of the material. It's coming with a wide matrix of options available. In terms of length, up to 225 mm.
Diameters as small as 20 mm, and tapered device to treat particular anatomical needs. But probably the most important innovation is the possibility to have two proximal configuration options: the FreeFlo and the CoveredSeal.
Both tied to the tip of the device with the tip-capture mechanism that ensures proximal deployment of the graft that is very accurate. This graft is being under trial in a global trial
that included 100 patients all over the world. The first 87 patients have been submitted for primary endpoint analysis. 40% of the patients were females. High risk patients showed here by the ASA class III and IV. Most of the patients presented
with a fusiform or saccular aneurysm, and the baseline anatomy is quite typical for these kinds of patients, but most of the patients have the very tortuous indices, both at the level of the access artery tortuosity and the thoracic aorta tortuosity.
Three-fourths of the patients had been treated with a FreeFlo proximal end of the graft, while one-fourth with the CoveredSeal. Complete coverage of the left subclavian occurred in one-fifth of the patients. Almost all had been revascularized.
Procedure was quite short, less than one and half hour, percutaneous access in the majority of cases. There were no access or deployment failures in this series. And coming to the key clinical endpoints, there were two mortality reported out of 87 patients.
One was due to the retrograde type A dissection at day one, and one was not device related almost at the end of the first month. Secondary procedures were again two. One was in the case of retrograde type A dissection, and the second one in a patient
that had an arch rupture due to septicemia. Type 1a endoleak was reported in only one case, and it was felt to be no adverse event associated so was kept under surveillance without any intervention. Major Adverse Events occurred in 28% of the cases. Notably four patients had a stroke
that was mild and not disabling, regressing in two weeks. Only one case of spinal cord ischaemia that resolved by drainage and therapy in 20 days. In summary, we can say that the design enhancement of Valiant Navion improved upon current generation TEVAR.
Acute performance is quite encouraging: no access or deployment failure, low procedural and fluoro times, low rate of endoleaks, Major Adverse Events in the range expected for this procedure.
Nowadays the graft is USA FDA approved as well as in Europe CE mark. And of course we have to wait the five years results.
- Thank you Dr. Melissano for the kind interaction. TEVAR is the first option, or first line therapy for many pathologies of the thoracic aorta. But, it is not free from complications and two possible complications of the arch are the droop effect and the bird-beak. I was very interested as Gore came up with the new
Active Control System of the graft. The main features of this graft, of this deployment system are that the deployment is staged and controlled in putting in the graft at the intermediate diameter and then to the full diameter. The second important feature is that we can
optionally modify the angulation of the graft once the graft is in place. Was very, very interesting. This short video shows how it works. You see the graft at the intermediate diameter, we can modify the angulation also during this stage
but it's not really used, and then the expansion of the graft at the full diameter and the modification of the angulation, if we wished. This was one of the first cases done at our institution. A patient with an aneurysm after Type B dissection. You see the graft in place and you see the graft after
partial deployment and full deployment. Perhaps you can appreciate, also, a gap between the graft and the lesser curvature of the arch, which could be corrected with the angulation. As you can see here, at the completion angiography we have an ideal positioning of the graft inside the arch.
Our experience consisted only on 43 cases done during the last months. Mostly thoracic aneurysm, torn abdominal aneurysm, and patients with Type B aortic dissection. The results were impressive. No mortality, technical success, 100%,
but we had four cases with problems at the access probably due to the large bore delivery system as you can see here. No conversion, so far and no neurological injury in this patient group. We have some patients who came up for the six months follow-up and you see here we detected one Type 1b endoleak,
corrected immediately with a new graft. Type II endoleak which should be observed. This was our experience, but Gore has organized all the registry, the Surpass Registry, which is a prospective, single-arm, post market registry including 125 patients and all these patients
have been already included in these 20 centers in seven different countries in Europe. This was the pathology included, very thorough and generous, and also the landing zone was very different, including zone two down to zone five. The mean device used per patient were 1.3.
In conclusion, ladies and gentlemen, the Active Control System of the well known CTAG is a really unique system to achieve an ideal positioning of the graft. We don't need to reduce the blood pressure aggressively during the deployment because of the intermediate diameter
reached and the graft angulation can be adjusted in the arch. But, it's not reversible. Thank you very much for your attention.
- Thank you very much, Frank, for the opportunity to be part of this fantastic panel. So, I'm no more a part of the debate, and I will not show the differences, but if we look on the arch, on the literature addressing the different types of repair, we can see that the result are in the same range, approximately.
And despite the fact that we didn't spoke about this, probably, there is a bias of selection where else the best patient will be addressed by open surgery, patient that fits for branched and FEVAR will be treated by those technology, and the remaining of the patient
is addressed by parallel grafts. There is a second point I would like to address and this is one part of my talk, is that the results for the endovascular options are not good, are not so long described in the literature. There are some papers with longer follow-up,
but in the mean, the follow-ups are rather short. So, let's go to our expanse that is a little bit longer. In the arch, we treated 94 patients. We had a mortality of 14% stroke, or neurological complication 8%, endoleak, primary, 18%, but we addressed 40% of acute patients,
and 50 patient with redo thoracic surgery. So, an example: 75 years old patient, he had complicated type B dissection with malperfusion, did get the TEVAR with a sandwich for the LSA. In the follow-up, he showed an aortic enlargement with the dissection extending proximal to the LSA,
and he had, again, and antegrade perfusion of the sur-lumen. He refused general anesthesia because he had severe delire when he was treated first. So we address this with periaortic grafts. We put one chimney for the brachiocephalic trunk in the aorta, one chimney for
the left carotid artery in the ascending aorta, then we deployed a TAG in the aorta then, to match the diameter of the BCT we extended the first viable, which is 13 mm, and you can see here, the six month follow-up with a nice result. So, if we want to go to long-term results,
we freezed a cohort of patient we treated 2009 to 2014. These are 41 patients with an Euroscore II of 28%, 68 years the mean age, 30 day mortality was 12%, so half of the predicted. You see here 42 months follow-up of this cohort. There is this typical mortality of 10% a year
following the procedure, due to the comorbidity cardiac pulmonary renal functions, freedom of branch occlusion is nice and the branch behaved stable. There have been reintervention during the follow-up, mainly to treat endoleaks, branch issues,
or other problems on this patient, but you see there is a three and a half year follow-up and the rate of reintervention is the same than for other endovascular options. Looking now at the more complex patients, the free vessel in the arch, you see
that the results here are good too, for the parallel grafts. Here down, we see one patient dying, no stroke, no endoleak. If we go to the visceral patient, here the literature review shows a mortality of 4.7%, with an endoleak type 1A of 7% for the parallel grafts. If we do compare now CHIMPS with FEVAR and open repair,
you can see that maybe the difference is more redo, but it's not really much more than for the FEVAR/BEVAR, and here is particularly due to the gutters. We treated here also for the long-term follow-up, we freezed a cohort of patient, 127 patient, 40% symptomatic, 11% ruptured patient.
Hostile chest, 37%, hostile abdomen, 26%. Most of the proximal landing was above the renal artery, mostly chimneys, but also reversed grafts and sandwich. Here a case, patient that was rejected after rupture from two centers to one because he was unfit for surgery, the other because he qualified not for FEVAR/BEVAR.
He had a challenging anatomy with an occluded left renal artery and celiac trunk, a shaggy arch and LSA, so we treated him transfemorally with two parallel grafts and you see the outcome of this patient. So, there are reinterventions. The mortality in this cohort is 2.4%, endoleak is 7%.
Reintervention, chimney-related, mainly gutter endoleaks. These are the curves in the follow-up, and you see that the results are similar than the patient in the arch with a need for reintervention, but that's the same for any kind of endovascular procedure in the arch.
18% at three years of reintervention. This has been for branch thrombosis or endoleak cages. So, in conclusion, the results are good for parallel grafts in the arch and in the visceral types, and selected patient, they need an appropriate anatomy, a life expectancy of two years.
They behave durable up to more than three years mean follow-up, taking into account the number of reintervention. The unsolved issue with the parallel graft is the gutter, so this technique can improve, and you can see here that they may be solution for the future.
This is an anti-gutter design from Endospan that really eliminates any kind of gutter endoleak and wandering, and this will be the patient cohort that we will compare with other repair technique in the future. Thank you very much for your attention.
- 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 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.
- Thanks very much, and thanks Frank for the invitation to join us once again at this excellent meeting. These are my disclosures. Now, it's well documented and all of you are fully aware that the periprocedural risk of stroke and death following transfemoral CAS
has been shown to be twice that of when compared with CEA in the important non-industry supported trials of EVA3s, ICSS, and CREST. The increase in the rate of events with CAS however,
is front loaded and occurs, certainly within the first 30 days, and more often than not within the first day or two, after that the subsequent event rates and durability parallel that of CEA. And this is nicely shown in the four-year data from EVA 3S, where we can see that the big jump in event rates
between CAS and CEA occurs upfront, after which, these two curves become entirely parallel. The 10-year data from CREST has been published, and the same phenomenon occurs here, and that is that the higher event rate with stenting compared with carotid endarterectomy occurs right here,
after which the two curves become entirely parallel. So, one has to ask what are the potential causes for periprocedural events with transfemoral CAS and it's already been discussed, a diseased aortic arch, a Type 3 aortic arch making catheterization of the right carotid artery more challenging,
and finally the need to traverse the lesion in order to place a distal embolic protection device. Obviously the embolic protection device doesn't work until it's in place, and when you pass it over the lesion the possibility of knocking free embolic debris is quite high.
I don't expect anybody to read this from the back of the room, but in 2004 there were two seminal papers that were published looking at the possibility of a direct approach to carotid artery stenting, thus avoiding the aortic arch and using flow reversal
by clamping the common carotid artery and diverting blood flow in a reverse direction back to the venous system and were showed excellent results. Along comes industry to provide us with the hardware with which to do this,
these are the components from Silk Road, and basically a small cutdown over the common carotid artery, the placement of the sheath clamping the carotid artery with reversal of flow, thus carrying any embolic material before the placement of a stent is neuroprotective.
One other thing that wasn't mentioned this morning and one of the advantages of flow reversal and the possibility of encouraging all of the release of the embolic material initially is to carry out predilatation of the lesion before placing the stent and not postdilate.
The first-in-man data on the use of this technique was published in Germany and in the proof study, in the proof study there were 44 patients undergoing TCAR, no deaths, no strokes, silent brain infarction rate of 16%, which was entirely comparable to that of carotid endarterectomy.
Along comes the ROADSTER trial at ROADSTER 141 pivotal patients deemed to be high risk by either anatomic or medical criteria, carried out in 20 US sites, there was no major strokes, there were two minor strokes, two deaths, no permanent cranial nerve injuries. And if we compare the TCAR data with CREST data,
here's the transfemoral CAS data out of CREST, 4.1%, 2.3% with carotid endarterectomy, 1.4% with TCAR. And here are the ROADSTER 2 data, if we look at stroke and death in asymptomatic patients in ROADSTER 1, 1.3% dropping to .9%,
stroke and death, ROADSTER 1 in symptomatic patients 2.2% dropping to an astonishing 0.8%. So, from my personal perspective I can offer patients either TCAR or CEA based upon selection criteria with a high degree of comfort that
both of these are going to result in excellent results. How about CREST-2, as you know this is two studies in one, comparing CAS with intensive medical therapy alone and CEA with intensive medical therapy versus intensive medical therapy alone. The future of invasive intervention
to treat asymptomatic carotid stenosis will really depend upon the results of this trial. What are the possible outcomes? Intensive medical management may be equal to or better than either, carotid endarterectomy and CAS may be better than intensive medical management,
or CEA but not CAS may be better than intensive medical management alone, those are the possible possibilities To date, half of the patients have been enrolled, so stay tuned, and thanks very much for your attention.
- Thank you. Thank you again for the invitation, and also my talk concerns the use of new Terumo Aortic stent graft for the arch. And it's the experience of three different countries in Europe. There's no disclosure for this topic.
Just to remind what we have seen, that there is some complication after surgery, with mortality and the stroke rate relatively high. So we try to find some solution. We have seen that we have different options, it could be debranching, but also
we know that there are some complications with this technique, with the type A aortic dissection by retrograde way. And also there's a way popular now, frozen elephant trunk. And you can see on the slide the principle.
But all the patients are not fit for this type of surgery. So different techniques have been developed for endovascular options. And we have seen before the principle of Terumo arch branch endograft.
One of the main advantages is a large window to put the branches in the different carotid and brachiocephalic trunk. And one of the benefit is small, so off-the-shelf technique, with one size for the branch and different size
for the different carotids. This is a more recent experience, it's concerning 15 patients. And you can see the right column that it is. All the patients was considered unfit for conventional surgery.
If we look about more into these for indication, we can see four cases was for zone one, seven cases for zone two, and also four cases for zone three. You can see that the diameter of the ascending aorta, the min is 38,
and for the innominate artery was 15, and then for left carotid was eight. This is one example of what we can obtain with this type of handling of the arch with a complete exclusion of the lesion, and we exclude the left sonography by plyf.
This is another, more complex lesion. It's actually a dissection and the placement of a stent graft in this area. So what are the outcomes of patients? We don't have mortality, one case of hospital mortality.
We don't have any, sorry, we have one stroke, and we can see the different deaths during the follow-up. If we look about the endoleaks, we have one case of type three endoleak started by endovascular technique,
and we have late endoleaks with type one endoleaks. In this situation, it could be very difficult to treat the patient. This is the example of what we can observe at six months with no endoleak and with complete exclusion of the lesion.
But we have seen at one year with some proximal type one endoleak. In this situation, it could be very difficult to exclude this lesion. We cannot propose this for this patient for conventional surgery, so we tried
to find some option. First of all, we tried to fix the other prosthesis to the aortic wall by adjusted technique with a screw, and we can see the fixation of the graft. And later, we go through the,
an arrangement inside the sac, and we put a lot of colors inside so we can see the final results with complete exclusion. So to conclude, I think that this technique is very useful and we can have good success with this option, and there's a very low
rate of disabling stroke and endoleaks. But, of course, we need more information, more data. Thank you very much for your attention.
- Thank you Rod and Frank, and thanks Doctor Veeth for the opportunity to share with you our results. I have no disclosures. As we all know, and we've learned in this session, the stakes are high with TEVAR. If you don't have the appropriate device, you can certainly end up in a catastrophe
with a graph collapse. The formerly Bolton, now Terumo, the RelayPlus system is very unique in that it has a dual sheath, for good ability to navigate through the aortic arch. The outer sheath provides for stability,
however, the inner sheath allows for an atraumatic advancement across the arch. There's multiple performance zones that enhance this graph, but really the "S" shape longitudinal spine is very good in that it allows for longitudinal support.
However, it's not super stiff, and it's very flexible. This device has been well studied throughout the world as you can see here, through the various studies in the US, Europe, and global. It's been rigorously studied,
and the results are excellent. The RelayPlus Type I endoleak rate, as you can see here, is zero. And, in one of the studies, as you can see here, relative to the other devices, not only is it efficacious, but it's safe as well,
as you can see here, as a low stroke rate with this device. And that's probably due to the flexible inner sheath. Here again is a highlight in the Relay Phase II trial, showing that, at 27 sites it was very effective, with zero endoleak, minimal stent migration, and zero reported graph collapses.
Here again you can see this, relative to the other devices, it's a very efficacious device, with no aneurism ruptures, no endoleaks, no migration, and no fractures. What I want to take the next couple minutes to highlight, is not only how well this graph works,
but how well it works in tight angles, greater than 90 degrees. Here you can see, compliments and courtesy of Neal Cayne, from NYU, this patient had a prior debranching, with a ascending bypass, as you can see here.
And with this extreme angulation, you can see that proximally the graph performs quite well. Here's another case from Venke at Arizona Heart, showing how well with this inner sheath, this device can cross through, not only a tortuous aorta, but prior graphs as well.
As you can see, screen right, you can see the final angiogram with a successful result. Again, another case from our colleagues in University of Florida, highlighting how this graph can perform proximally with severe angulation
greater than 90 degrees. And finally, one other case here, highlighting somebody who had a prior repair. As you can see there's a pseudoaneurysm, again, a tight proximal, really mid aortic angle, and the graph worked quite well as you can see here.
What I also want to kind of remind everybody, is what about the distal aorta? Sometimes referred to as the thoracic aorta, or the ox bow, as you can see here from the ox bow pin. Oftentimes, distally, the aorta is extremely tortuous like this.
Here's one of our patients, Diana, that we treated about a year and a half ago. As you can see here, not only you're going to see the graph performs quite well proximally, but also distally, as well. Here Diana had a hell of an angle, over 112 degrees,
which one would think could lead to a graph collapse. Again, highlighting this ox bow kind of feature, we went ahead and placed our RelayPlus graph, and you can see here, it not only performs awesome proximally, but distally as well. And again, that's related to that
"S" shaped spine that this device has. So again, A, it's got excellent proximal and distal seal, but not only that, patency as well, and as I mentioned, she's over a year and a half out. And quite an excellent result with this graph. So in summary, the Terumo Aortic Relay stent graph is safe,
effective, it doesn't collapse, and it performs well, especially in proximal and distal severe angulations. Thank you so much.
- 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.
- 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.
- We are to have a distinction between acute stroke at level of distal small vessels, in which we can see the core infarct in the penumbra around the infarct. And for the treatment of acute stroke, it's important to establish the eligible patient who will receive the
intravenous tissue plasminogen activator. It remains the only proven effective intervention for acute ischemic stroke. But what about the acute stroke for large vessel intra-arterial thrombolysis? What alternatives?
Mechanical revascularization strategies or stent-assisted revascularization. But, in the past, the earliest periods studied was anecdotal cases and no selection of the patients so bad results were recorded.
We have some exclusion criteria for the urgent treatment. Internal major stoke, cerebral ischemic lesion greater than 2.5 centimeter and CT scan, loss of consciousness,
signs of intracranial hemorrhage. But the real goal of early intervention is to stop the plaque embolization. So should we remove this plaque, or we can stent it. So, as what said Rothwell in 2004, time is brain.
And the benefit from CEA is maximal in symptomatic patients operated on within two weeks of the index event. But it's better after 48 hours. In 2010, I published Siena Carotid Artery Stenting Score
for elective patients. And in Italian registry, in order to evaluate that the field urgency of carotid emergency stenting of a symptomatic patient, we have noticed some clinicians had biomarkers spotted from a prospective registry.
And we have studied the Brain ischemia biomarkers such as PAPP-A, hs-CRP, and Interleukin six. But in the (mumbles) published only in European journal of Vascular and Endovascular Surgery said,
that the most effective management is the quickest one. So in this publication, I say that this closed cell stent design would be benefit for the treatment of urgent patients. In this same publication in the Annals of Vascular Surgery.
And in this year, we studied the early carotid artery stenting after onset of neurological symptoms. So we know very well that we are some cerebral protection devices in order to better protect the procedure,
and we had the necessity to obtain a better protection device with proximal absolute devices. So what about new carotid stent design? In order to better approach the symptomatic patients. This is an example at Terumo Roadsaver, with the control with optical cord and tomography.
This is an example of C-Guard with the control optical cord and tomography. We established some cases related to the study with OCT, and the slice-based analysis say that compared with conventional stents,
the incidence of plaque prolapse was lower. So how to choose in emergency. Carotid artery or carotid endarterectomy stenting, my personal opinion, carotid endarterectomy is still the gold standard. Or if we had the space for carotid stenting
in patients with severe comorbidities, in patients with anatomic complex situations, in case of tandem intracranial lesions, but requires correct expertise and plaque evaluation and correct stent and cerebral protection. So in conclusion,
the most effective management is the quickest one, according to a correct selection that allows recognition of those who can really take advantage for early treatment. And how to perform CAS safely in emergency with an appropriate knowledge of
anatomy, anomalies, and equipment. And with growing experience and the use of dedicated CAS technology, CAS can now be performed safely and efficiently by skilled operators even in urgent cases. Thank you for your attention.
- Dear chairman, dear colleagues and friends, it's my pleasure to be again with you. Nothing to declare. In our experience of CCSVI and angioplasty we have more than 1,300 patients with different neurological disorders. Not only MS, but also migraine,
lateral amyotrophic sclerosis, Parkinson's disease, left sided amaurosis. We published our data with an emphasis on the safety of the procedure. We had virtually zero percent of serious complication. What about the clinical improvement?
In fact, we noticed function improvement in more than 62.5% of these patients. And in fact, the group of Pierfrancesco Veroux showed similar between 50 and 60% of the patients restoring the normal blood venous flow. In fact, in their work was shown that the type
of anatomic disturbance, anatomic feature is very important predictor if the flow will be restored by the simple PTA. And the most important into the brave dream trial was also that, in fact, the restoration of the flow was achieved in around 70% of the patients.
And exactly in these 70% of the patients with restored flow like Paulo emphasized already, there were lesion, 91% of them were lesion-free on the MRI, and 77% of them were lesion-free on the six-month. We performed a substudy regarding the hypercapnia
and hypoxaemia of the jugular veins in the CCSVI-positive patients. And what we have described in this 178 patients with CCSVI and 50 healthy control group. In fact, we established that the patients CCSVI-positive the venous sample by the jugular veins was typical
with hypercapnia and hypoxaemia in desaturation, huge desaturation with improvement after the balloon angioplasty in all three parameters. What was the reason for that? In fact, in nine patients of our group we examined, the perfusion, the nuclear perfusion of the brain
before and after the treatment. I'm here presenting non-positive for MS young patient without MRI demyelization. And but on the brain perfusion he had deep hyperperfusion on the left side, and the patient was complaining with deep fatigue.
And we saw practically full occlusion of the enominate vein. And after the recanalization using first coronary and after it peripheral balloons, and in this particular case we had to stent finally. And you see still persistence of a huge crossover collateral even after ballooning.
But after stenting we saw practically full restoration of the flow. You see in less than three to four seconds it was very interesting to see on the perfusion imaging, nuclear perfusion, full restoration of the flow of this gentleman.
So this is very important to emphasize that there is direct relationship between the blood gas disturbances on the brain level, and demyelinization process. What about the PTA? It's probably not the optimal treatment.
We have to establish reliable clinical and anatomical predictors for vascular and clinical success in order to answer the important questions: who will be vascular responders, or MRI responders, and finally the clinical responders in this group of patients?
And concluding, ladies and gentlemen, the CCSVI is a real vascular pathologic entity and is probably a trigger for more than one neurologic degenerative disorder. Endovascular treatment, balloon, PTA, and stenting of CCSVI is feasible and safe.
Methods and strategies improving the early and late patency rate have to be elaborated because the good clinical result is strongly dependent on the vascular patency and flow restoration. And thank you very much 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.
- 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.
- Yeah, thank you very much. Unfortunately Dierk Scheinert couldn't come, so thankfully he's allowed me here to take this presentation over so thanks a lot for this. So these are the latest 5-year results of the INCRAFT device from Cordis Devices currently under FDA review not yet approved
in the US, but in Europe. These are the conflict of interests, this is (mumbles). So this device is a three-piece modular system, low porosity polyester. You can bilaterally in-situ length adjust it up to 3cm. And the main feature I think with this device
is it's a low-profile device, 13 Fr inside 14 Fr outside except the biggest body which has an outer diameter of 16 Fr. The innovation study that was 60 patients, you can see here some objectives. So the question was whether you could deploy it
accurately where you wanted to have it without any type I, III, and IV endoleaks and of course there were also some other primary and secondary endpoints and again follow-up had to be done up to five years. This is a busy slide just showing you,
please look to the right side, to show you that there were quite some violations of the recommendations in which kinds of anatomies to implant this craft. Here for example neck lengths less than 10mm, here were some patients implanted.
Also angulations over 60 degrees, three patients, there were some thrombus in the neck, and here you can see aortic bifurcation smaller than 18mm, there were quite some patients and especially the iliac sealing length was shorter than 10mm in nearly 50% of the patients
and also the diameter of the external iliac arteries were nearly 50% lower than 7mm. Here the freedom from endoleaks type I was one at 30 days which has been resolved and another one developed after 30 days which also has been involved. No type III.
Stent graft patency after 30 days also 100% and otherwise also no other adverse events with this device at thirty days. So to answer the question with this device to the first question of (mumbles) will lighter fabrics and stent material decrease EVAR durability?
Will there be more endoleaks I, III, or IV? You can see here the long-term data so no Ia endoleak developed over four and five years, there was one Ib endoleak which developed at four years which also was apparent at five years. No type III endoleak.
One graft patency failure with a (mumbles) occlusion here at four years which also was here at five years. No migration, one fraction of the (mumbles) proximal third graft, otherwise it was very safe. You can see here once again the Kaplan-Meier curve for type I endoleaks through five years here
with type Ib here later on, and this is the patency Kaplan-Meier curve also showing here the good patency at five years, and this is freedom from second large vent. Here I don't have any data whether this is type II endoleak or not so this still has to be reported and clarified.
So to conclude the INCRAFT performed well on long-term while overcoming more difficult access morphologies. The endograft can be utilized in patients with demanding access and vessel morphology, and there are more studies ongoing.
There is one in the US and Japan where we wait for long-term data, 190 patients and also from Europe's 180 patients also there we still wait for long-term data. Thank you.
- Thank you to the committee and Dr. Veith for inviting me to speak today. Here are my disclosures. Over the past several years there's been a large increase in the wave of opioid overdose deaths in both heroin and prescribed narcotics in the US. Infected pseudoaneurysms are a terrible problem
resulting from this that vascular surgeons are seeing more increasingly. With this increase in IVDA use, we want to evaluate the trends in the increase and treatment of groin pseudoaneurysms and we used the National Inpatient Sample.
This looked over ten years from 2004 to 2014. Patients with a primary diagnosis of aneurysm or pseudoaneurysm, as well as different ICD-9 codes which were related to drug abuse. Looking at these data from 2004 to 2014, there was a large increase in the diagnoses
of pseudoaneurysms in IV drug abusers. Looking at the demographics of these patients, around 75% of these were white males with the average age of 45. This data, the location was mostly the West, hospital type was usually at an urban teaching hospital. Only 15% of these patients had private insurance.
Most of them were Medicaid, self-pay or no charge. As far as operative approach, and again, this is from a large database using codes, the resection of vessel with replacement had the highest increase, but there was an increase in all the operative approaches, including vascular shunt or bypass or aneurysm repair.
Which leads us to the question of what's the optimal therapy for IV drug abuse mycotic pseudoaneurysms? There's several surgical options, including ligation debridement with non-selective revascularization, ligation debridement of the aneurysm with selective revascularization, just ligation and excision and the
possibility of stents has been brought to attention recently. This study from Iran looked at 41 patients who were IV drug abusers with infected pseudoaneurysms. Of these patients, 32 patients were primarily ligated and nine patients were ligated with revascularization.
Of those patients, the ligation and excision, there were nine of 32 patients had complications and there was one amputation in this study. With a ligation and early revascularization, six out of nine patients had complications and there were three early graph failures.
These patients were only followed up to nine months. Of note, in this population, studies are often poor as the follow-up, as you can imagine, at these institutions is not very good. This study from Dr. Padberg and Hobson's group from the early 90's looked at performing
selective revascularization and using external iliac clamping to assess distal flow with a hand-held doppler, although further studies have looked at use of pulse oximetry as well. If there was a dopplerable signal, they felt there was no need to reconstruct at the time of surgery.
Using these methods, six patients had just a ligation with no mortality, no re-operations. Twelve of the 18 patients had a revascularization as well, and there were three amputations, no mortality. There are other extra-anatomic ways to reconstruct. Dr. Caligaro will describe the lateral tunneling
in a further talk in this session. An obturator bypass is another good option. Axel popliteal bypasses have also been described by Dr. Veith and his group several years ago. A new method that I've used instead of external iliac artery clamping is getting
proximal control from the contralateral groin. I usually get a CTA on these patients and use a 8 to 12 millimeter ballon, which often saves a retroperitoneal incision. As far a stenting, there's some, few studies looking at the use of stent in this patient population.
This study from China, 29 patients with pseudoaneurysms in SFA were treated with a covered stent. There was only short-term follow-up, but there was no amputation, no pain in these patients. And five patients continued to inject at the site. Here's another small case series describing
a retrograde stenting after a cutdown on the SFA into the common femoral artery, and they had two patients in the series with no complications over two years. Conclusion, IV drug abuse is on the rise and we're seeing more of the pseudoaneurysms that we'll need to treat. The data is difficult, but ligation may be the
best outcomes if there is a dopplerable signal. And for an absolute emergency, stenting may be used, however, on these young, non-compliant patients it is unlikely to be a good long-term option. Thank you.
- Thank you very much, Gustavo, you read the abstract so now my task is to convince you that this very counter-intuitive technique actually works, you are familiar with Petticoat, cover stent to close a proximal entry tear and then uncover stents, bear stents, downstream. This what it would look like when we open up
the bare stent, you know dissect the aorta. So here's a case example, acute type B with malperfusion, the true lumen is sickle shaped, virtually occluded. So we use Petticoat, and we end up with a nice reopening of the true lumen, it is tagged here in green, however if you look more closely you see that here
wrapping around the true lumen there is a perfused false lumen. This is not an exception, not a complication, this is what happens in most cases, because there are always reentries in the celiac portion of the aorta.
So the Stablise concept was introduced by Australian group of Nixon, Peter Mossop in 2012, after you do the Petticoat, you are going to voluntarily balloon inside both the stent graft and the bare stents in order to disrupt, to fracture the lamel, obtain a single-channeled aorta.
This is what it looks like at TEE, after deployment of the stent graft, you see the stent graft does not open up completely, there is still some false lumen here, but after the ballooning, it is completely open. So the results were immediately very, very good, however technique did not gain a lot of consensus,
mainly because people were afraid of rupturing the aorta, they dissect the aorta. So here's a Stabilise case, once again, acute setting, malperfusion, we do a carotid subclavian bypass because we are going to cover the subclavian artery, we deploy
the cover stent graft, then with one stent overlap, we deploy two bare stent devices all the way down to the iliacs and then we start ballooning from the second stent down, so you see Coda balloon is used here, but only inside the cover stent with fabric.
And then more distally we are using a valvuloplastic balloon, which is noncompliant, and decides to be not larger than the aorta. So, I need probably to go here, this is the final result, you can see from the cross-sections that the dissection is completely gone and
the aorta is practically healed. So you might need also to address reentries at the iliac levels, attention if you have vessels that only come from the false lumen, we want to protect them during the ballooning, so we have a sheath inside this target vessel, and we are
going to use a stent afterwards to avoid fragments of the intima to get into the ostium of the artery. And this is a one-year control, so as you can see there is a complete remodeling of the aorta, the aorta is no longer dissected, it's a single channel vessel, here we can see stents in two vessels that came
from the false lumen, so very satisfactory. Once again, please remember, we use compliant latex balloons only inside the the cover stent graft, and in the bare stents we use non-compliant balloons. We have published our first cases, you can find more details in the journal paper, so in conclusion,
dear colleagues, Stabilise does work, however we do need to collect high-quality data and the international registry is the way to do this, we have the Stabilise registry which is approved by our ethical committee, we have this group of initial friends that are participating,
however this registry is physician initiated, it's on a voluntary base, it is not supported by industry, so we need all the possible help in order to get patients as quickly as possible, please join, just contact us at this email, we'd be more than happy to include everybody who is
doing this technique according to this protocol, in order to have hard data as soon as possible, thank you very much for your attention.
- 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.
- Thank you Mr. Chairman. Thank you, Dr. Veith for you kind invitation. Okay, there we go. Excuse me. DEVASS stands for Dutch EVAS study Group. We all know that women have a twofold, increased risk frequency of rupture.
The average aortic size at rupture is five millimeters smaller. They have a higher rate of undiagnosed cardiovascular diseases. They have smaller ileofemo
more concomitant iliac aneurysms They have a more challenging aortic neck. Smaller proportion is eligible for EVAR and, therefore less likely to meet EVAR IFU. They have a longer length of hospital stay after EVAR, a higher re-admission rate, more major complications,
a higher mortality rate. So, women and AAA is a challenging combination. The rationale behind EVAS is known to you all, I think. The DEVASS cohort is from three high volume centers in The Netherlands. It's a retrospective cohort of 355 patients,
included from April, 2013 to December 2015. So I have two years of result data. If you look at the baseline characteristics, 45 females were in this cohort, with the age of 76 and with some known comorbidities. They were within the instructions for use of 2013, at 28.9%
and even less in the IFU of 2016. These are some more anatomical characteristics with the AAA outer diameter 5.6 centimeters. This is the procedure, most of the patients were under general anesthesia, with the cutdown and the procedure time
was about 100 minute. Straight forward procedure 33 cases out of these 45. Let's have a quick look at the clinical outcomes. The re-intervention's done in the first 12 month. One patient had to conversion to open repair at month 11 due to type 1A Endoleak, and the others were not directly
related to the procedure itself. Although, there was thrombus in approximate stand. In the second month we saw, in the second year we saw some more type 1A migrations and a Stenosis that needed relining, and two out of these patients were within IFU.
If you look at the total cohort of type 1A Endoleak, one patient was not operated on and the other were, either open conversion or relining, and one patient was within IFU. A quick look at the death characteristics. Only one patient was within IFU,
and died after open procedure. So the re-interventions, once again, the first year four patients, in the second year five patients. Conversion to open repair, in total three patients. Endovascular re-intervention was performed
in the first year in two patients and in the second year there were three relinings performed. Endoleak 1A, in total six as stated before. No type two Endoleak reported, and in the first year five patients died, which one was aneurisym related, as in the second year, two patients died,
which one was aneurysm related. If we compare this data with the EVAS Global data, of two years not the three year data, this is the freedom from all persistent Endoleak, close to 98% which is good. Freedom from type 1A Endoleak is within IFU, 97% in the global and outside IFU 85%,
and remind these patients 71% were outside IFU. Freedom from secondary interventions, we had to re-intervene in nine patients and its comparable with outside IFU. Freedom from mortality at two years, a bit higher, aneurism related mortality is 95% which is higher, and also the all cost mortality is higher in women.
So to conclude, this is the first cohort that focuses on women after EVAS. The majority of the patients was outside IFU, and as in EVAR women do not that very good in result, appear to be very much like an EVAR. Thank you.
- Thank you very much for the presentation. Here are my disclosures. So, unlike the predecessor, Zenith Alpha has nitinol stents and a modular design, which means that the proximal component has this rather gentle-looking bear stents and downward-looking barbs.
And the distal part has upward-looking barbs. And it is a lower-profile device. We reported our first 42 patients in 2014. And now for this meeting we updated our experience to 167 patients operated in the last five years.
So this includes 89 patients with thoracic aneurysms. 24 patients in was the first step of complex operations for thoracoabdominals. We have 24 cases in the arch, 19 dissections, and 11 cases were redos. And this stent graft can be used as a single stent graft,
in this case most of the instances the proximal component is used or it can be used with both components as you can see. So, during the years we moved from surgical access to percutaneous access and now most of the cases are being done percutaneously
and if this is not the case, it's probably because we need some additional surgical procedures, such as an endarterectomy or in cases of aorto-iliac occlusive disease, which was present in 16% of our patients, we are going to need the angioplasty,
this was performed in 7.7% of cases. And by this means all the stent grafts were managed to be released in the intended position. As far as tortuosity concerned, can be mild, moderate, or severe in 6.6% of cases and also in this severe cases,
with the use of a brachio-femoral wire, we managed to cross the iliac tortuosity in all the cases. Quite a challenging situation was when we have an aortic tortuosity, which is also associated with a previous TEVAR. And also in this instances,
with the help of a brachio-femoral wire, all stent grafts were deployed in intended position. We have also deployed this device both in chronic and acute subacute cases. So this can be the topic for some discussion later on. And in the environment of a hybrid treatment,
with surgical branching of the supoaortic tranch, which is offered to selected patients, we have used this device in the arch in a number of cases, with good results. So as far as the overall 30-day results concerned, we had 97.7% of technical success,
with 1.2% of mortality, and endoleaks was low. And so were reinterventions, stroke rate was 1.2%, and the spinal cord injury was 2.4%. By the way we always flash the graft with CO2 before deployment, so this could be helpful. Similar results are found in the literature,
there are three larger series by Illig, Torsello, and Starnes. And they all reported very good technical success and low mortality. So in conclusion, chairmen and colleagues, Zenith Alpha has extended indications
for narrow access vessels, provide safe passage through calcified and tortuous vessels, minimize deployment and release force, high conformability, it does retain the precision and control of previous generation devices,
however we need a longer term follow up to see this advantages are maintained over time. Thank you very much.
- [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.
- Here we go. So, we know that late survival of patients with aortic aneurysms is not as good as matched controls and much of this is related to higher incidents of cardiovascular events. Other factors that impact survival are aneurysm size, as well as antiplatelet and statin therapy.
And we know that EVAR has no long-term survival advantage compared to open repair and, in fact, aneurysm related survival is worse after eight years for EVAR rather than open repair and, yet, 50% of our aneurysm patients are alive eight years after repair.
We've already seen about the differences in the mechanism of EVAR versus EVAS. With EVAR there's sac thrombosis, with or without endoleak, and we've previously shown that with sac expansion there's a significantly worse late survival compared to patients with no sac expansion.
This was a VSGNE study and then a larger VQI study showed that not only is sac expansion have worse survival but, even failure to regress so stable sacs also have worse survival compared to those that have sac regression. And this is independent of whether or not there's
an endoleak or reintervention. So, this prompted us to wonder if EVAS might be associated with a difference in All Cause Mortality compared to EVAR, and we know the act of sac management processed with EVAS involves obliteration of the flow loom and minimizing the chance for
type two endoleaks. This was spurred on by, as Jeff had mentioned previously, the excellent freedom from All Cause and Cardiovascular Mortality seen both in the US IDE but also in the global registry. And, on top of that, in a comparison with the report
from the Mayo Clinic, when looking at the EVAS patients from those two studies broken down by aneurysm diameter there seem to be, again, a difference in a three year survival of the EVAS patients compared to traditional EVAR. Why might this be? Well, several reports have come out demonstrating a
difference in post implant syndrome, various inflammatory markers, major adverse events, cardiac adverse events and endoleaks when comparing EVAS with EVAR. And, CRP levels are elevated in the entire
early post operative period with EVAR relative to EVAS. So, we wanted to compare All Cause Mortality with EVAS to EVAR so we used the 333 patients from the US IDE trial, from 2014 to 2016, and a comparison group we used all the EVAR patients in the US VQI
from the same time period and then applied the same exclusion criteria from the IDE being patients on dialysis or with elevated creatinine or rupture were excluded and then we used propensity weighting to account for differences is baseline characteristics and we did
weighting based on aneurysm characteristics and cardiovascular risk factors and implied inverse probability weighting to compare the risk adjusted long-term survival. Our primary outcome was overall survival and this propensity weighted cohort, and as a secondary analysis
we compared survival when stratified by aneurysm diameter, a small, less than 5.5 or greater than or equal to 5.5. And, in the overall cohort what we found was EVAS survival at three years of 93% compared to 88% for EVAR, a 41% lower hazard for mortality that was statistically significant.
When we looked at the patients with smaller aneurysms, we found no benefit, no difference in survival between the EVAS and EVAR. But in the patients with the larger aneurysms greater than, or equal to, 5.5 we had 92% and 86% three year survival, so double the mortality rate
in the standard EVAR patients. So, in conclusion, EVAS seems to be associated with the higher long-term survival compared to EVAR, and this association was strongest in those with largest aneurysms. We think the biology of the AAA after EVAS plays a role,
and we think that this supports the continued evaluation and iteration of this therapy. Thank you.
- Yeah, thanks very much. Well, we've already heard that things were going well with the two first EVAS trials in the U.S and Europe predominantly, at one year and then we've seen those events described by both Jeff and Matt at two years. Root cause analysis refined IFU
and then prospectively studying this in the EVAS2 trial in the U.S but also in Europe and in the Asia-Pacific, in the Forward2 trial. I'm going to give you a little bit of an update. As we know there have been some concerning reports on retrospective reviews of experience in the early term,
and we've all heard about the details of the revised IFU, and the useful outcomes or grossly improved outcomes we can expect at two years and now Jeff has just told us at three years. Sorry, we'll just go back. So, as Matt mentioned, there have been several publications
that have retrospectively applied the IFU to center's experience to see if they could replicate the good outcomes that were achieved in the retrospective analysis of the IDE trial. Certainly, what is shown is that if you apply the revised IFU, you significantly reduce
patient applicability with this particular device. It has to be acknowledged that many of the procedures that were performed in these publications were performed, a) with a device that's different to the one that we're now going to use, and b) with a procedure that was very different.
It probably impacts on outcomes. I think the major difference with what we'll call the new Nellix device, is that it has the endobag attached firmly, not only to the top of the stent, but also at the bottom. And in our experience this attachment at the bottom
has had a particular impact on aneurysm sac size. The procedure has also evolved, and the procedure now involves steps such as unfurling of the endobags before stent deployment, and also pre-fill of the endobags with saline prior to filling with the polymer,
as well as the importance, as Matt mentioned, of accurately deploying and using all of the infrenal neck and the iliac sealing zones. We also performed a retrospective analysis of our experience in consecutive cases at Aukland Hospital with considerably longer follow-up.
And you can see that the patients on the modified IFU had a significantly different and improved freedom from type 1A endoleak, and also the composite end point of type one endoleak, sac expansion, and freedom from reintervention was highly significantly improved.
So that's a little bit different to the experience reported, possibly because we've been applying the optimized technique and had access to the new Nellix device for some time. So EVAS FORWARD 2 is being performed in Europe and in the Asia-Pacific region.
A 300-patient confirmatory trial with standard parameters. This is the very first case that was done. We did this in Aukland, and you can see something we weren't observing with the earlier Nellix device without the distal seal. We're seeing some cases with significant sac shrinkage.
You can see the earlier, or interim results, I'm just presenting for the first time here today from the FORWARD 2 trial. A very high freedom from type 1A endoleak, and freedom from reintervention, as of July 2018. Just out of interest, we also did a retrospective review
of patients in our own center that has had at least one year of follow-up using the new Nellix device with optimized procedures to see what the outcome would be, and you can see at one year that there's no type one endoleaks. Impressively, absolutely no migration.
We have seen at two years a couple of patients that had some sac growth. Even on IFU we felt that they had degeneration of their iliac arteries with loss of seal. Here you can see a case where you can see the dramatic sac shrinkage we're now seeing
in some cases, and this is the one where we saw some sac growth where we ended up doing a second reintervention to extend the distal seal. Of course, the real driver for us to continue with the Nellix and EVAS technology is this suggestive but very impressive freedom
from all cause in cardiovascular mortality. That really is driving us to use this technology in our patients. So in conclusion, we'll know that, in fact, there's ongoing evolution of this technology, and we're looking forward to being involved
in next generation EVAS that will follow the important EVAS2 and EVAS FORWARD trials sometime later in 2019. Thanks very much. (applause)
- 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.
- Yeah, thank you Mr. Chairman. These are my disclosures. Well, we know that the Heli-FX EndoAnchor System provide fixation and seal in aortic necks, and it can prevent or resolve migration or endoleaks. It's important to have an even spacing around aortic circumference and
to resolve type 1A endoleaks, you need successful, of course, deployment of EndoAnchors and adequate penetration into the aortic wall. The objectives for this study was to quantify the EndoAnchor penetration into the aortic wall in patients undergoing EVAR
and to assess the predictors of successful penetration and to associate that with postprocedural type 1A endoleaks. We searched in the ANCHOR database, and we included patients that has been treated for a type 1A endoleak, and we had to have a good quality
first postprocedure contrast-enhanced CT scan without any artifacts due to metal or glue, and without implantation of adjuvant aortic extension cuffs or stents. And then we selected two patient cohorts, patients with successful treatment
after the implantation of EndoAnchors for a type 1A endoleak, and patients with a persistent type 1A endoleak after the EndoAnchor implantation. Well, this is to show how we determined the position of the EndoAnchors, this is a good penetrating EndoAnchor
more than two millimeters in the aortic wall. This is borderline, and this means there is still a gap between the endograft and the aortic wall or the EndoAnchor itself is penetrating less than two millimeters. And this of course, a non-penetrating EndoAnchor.
The good ones are green, the borderlines are orange, and the non-penetrating are flagged red. Here are results, the anatomical criteria to predict type 1A endoleaks, as you can see here, at the left, in the type 1A endoleak patients, there is a larger aortic diameter
with a median of 30 millimeters, and neck length is shorter, less than one centimeter, compared to the patients with no endoleak. Then about the EndoAnchor penetration, in the patients with a persistent type 1A endoleak, there are significantly more EndoAnchors
which are borderline or non-penetrating. What are the predictors for a successful EndoAnchor penetration. Well, protective factors, oversizing of the endograft compared to the diameter of the infrarenal aortic neck, and the use of the endurant stents.
Independent risk factors are the aortic diameter at the lowest renal artery, and five and 10 millimeters below more than 30 millimeters, a significantly neck thrombus and calcium around the circumference and also a more than two millimeter thickness.
Predictors for a type 1A endoleak, protective factors is the neck length more than one centimeter, and good penetrating EndoAnchors and risk factors for a type 1A endoleak is, again, the aortic diameter five millimeters
below the lowest renal artery more than 30 millimeters, and also boerderline and non-penetrating EndoAnchors and in this logistic regression model, a non-penetrating EndoAnchor is really predictive for a type 1A endoleak, or a persistent type 1A endoleak. A few cases, this is an excellent job,
there are four EndoAnchors placed, and they all penetrate well, although they are not circumferentially divided around the circumference. The majority of the problems in the patients in the ANCHOR database, if a persistent type 1A endoleak
is mainly due to an incorrect indication, these are EndoAnchors red and orange, non-penetrating and borderline. That is because they are above the fabric, or they are in a no-neck aneurysm, so the indication is not correct.
This is again, a patient with an undersized endograft, of course, the EndoAnchors will never penetrate the aortic wall at a post-serial part of the aorta. This is another example of misdeployment, a huge load of calcium and thrombus, and again, to defined a no-neck aneurysm,
and again, well it's obvious that the EndoAnchors will not do their job. These are then the EndoAnchor distribution in successfully treated type 1A endoleaks at the left, 332 EndoAnchors, but if you select only the patients
with an EndoAnchor which are inside recommended use at the right, you can see that more than 90% of those EndoAnchors are good penetrating. Here are the patients at the left with a persistent type 1A endoleak, 248, and you can see the majority is red or orange,
and that means that majority of those patients had an EndoAnchor deployment beyond the recommended use. So to conclude, good EndoAnchor penetration is less likely when there is large aortic diameter, the EndoAnchor is not perpendicular to the stentgraft during deployment,
and it's beyond the recommended use, more than two millimeters of thrombus, not in the infrarenal neck, or a gap more than two millimeters. And in borderline or non-penetrating EndoAnchor, it's predictive for a type 1A endoleak.
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.
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