- Thank you. Thank you for the opportunity to present this technique and here are the results. Residual Type B Aortic Dissection in patients previously treated by TEVAR by frozen elephant trunk. It makes a new kind of patients need appropriate treatment.
There might be contraindication to further endovascular repair and these are associate visceral arterial dissection or occlusion, collapsed true lumen if it is relative, connective disorder, young age, excessive tortuosity and multiple renal arteries.
The reverse cactus principle is to implant two additional prosthesis to a main prosthesis very proximal and it is a four branch prosthesis like a cactus reversed and the principle is CSF drainage and potential. Left thoracophreno-laparotomy
and retroperitoneal abdominal aortic approach, left artio-femoral pump, double clamp of the proximal aorta within the endograft and make the proximal anastomosis with the graft while all the rest perfuses on below. Prepare the CT, superior mesenteric
and left renal at its origin outside the aorta and the ligature and section of the celiac trunk at its origin and anastomosis with one side-branch of the graft and then do the same with the other branches progressively while all the rest of the aneurysm is perfused
from below. Open the aorta, connect the intercostals and the right renal artery and make the distal anastomosis. So this is the double clamping of the proximal aorta and you can predict the presence of the endograft and so you have a proximal stamp.
A very firm proximal stamp when you can make the proximal anastomosis and you clamp the proximal anastomosis like blocked and so you have no ischemia and neither visceral nor spinal cord ischemia. You cut the celiac.
In this case the celiac was dissected, you identify the lumen by clamping alternately from one to the other side and you see there is the true lumen so you identify the true lumen and you suture it to this then you clamp the celiac trunk.
You do the same with the mesenteric artery and with the renal artery and then you open the sac and you perfuse the intercostals with an additional pump if necessary and after you are connected you are ready to do the distal anastomosis
and this is the final results. You see that it fits very well the anatomy into intercostal you see intercostal, intercostal and here are some examples. You see how the harmonic and the intercostals, posterior.
And so the early results were only a few patients deserved this operation but technical success was obtained in all cases. Two to six additional branches for each reconstruction. No 30 day mortality, reintervention or acute renal failure.
Spinal cord ischemia was reported unfortunately in one patient and it's a long operation but the intra-operative blood loss is contained for this kind of operation and the mean ICU stay was for 4.2 day. This is the curve of creatinine
which is a really very stable and all patients recovered within the six post recovery day. At one year reintervention was null. No patients developed late-onset renal failure. All visceral branches were present. We lost two intercostals without consequences.
In conclusion, residual type A aortic dissection is a challenging disease. The reverse cactus operation is no need for rush, it fits all anatomies, fixes associated visceral arterial disease, contains blood loss, great hemodynamic and metabolic stability
and satisfactory one year results. Thank you for your attention.
- BEVAR through the false lumen, it's rarely indicated. These are my disclosures. And usually, we proceed through the true lumen using BEVAR for post dissection aneurysm like in this case. From our experience, Regensburg and Nuremberg, at the moment the biggest surveys of 71 patient with post dissection aneurysm published
this year in European journal of Vascular and Endovascular Surgery. Sometimes it's necessary to go through the membrane from the true to the false lumen because of the urging of the arteries. And it was necessary in 14 out of 261
target vessels in this material. It makes about 5%. But sometimes, we have a very different cause of the chronic dissection. Like in this patient, where the true lumen shows a very big opening for the false lumen
and ends at the level of the renal arteries. And both legs are only perfused by the false lumen. So, what to do, and it was already some years ago, we decided to make a bypass from ascending to both femoral arteries and pseudoextenders use TEVAR for the aneurysm of the descending aorta.
Now, a case presentation, a 55 years old male patient with hypertension and nicotine consumption. He has had acute aortic dissection, 2014 with a true lumen collapse and dissection of superior mesenteric artery. He has had malperfusion of his intestine and right limb.
At that time, he was treated just by femoral-femoral bypass from left to the right and right hemicolectomy due to ischemic complication. Between 2014 to 2017, this dissection still started at the level of left subclavian artery. The aneurysm was progressive to 63 mm.
He has had the complete thrombosis of the thulomen at the level of the right renal artery with atrophic right kidney. He has had celiac trunk, left renal, and inferior mesenteric artery from the false lumen and dissected superior mesenteric artery.
The first procedure was in October, 2017 with the branching and the Amplatzer to the left subclavian artery to prevent retrograde flow. Branch device and uni-iliac tube because of occluded right iliac artery. After the first operation, we have seen
thrombosis of the thoracic aorta and patent segmental arteries at the level of celiac trunk. The second operation was deployment of covered stentgrafts balloon-expandable covered stentgrafts to the superior mesenteric, left renal and inferior mesenteric artery, why?
If you remember, the patient has had mesenteric dissection and only the right hemicolectomy. So we try to preserve all the collaterals to the intestine. And the third procedure, after balloon occlusion of the celiac trunk and branch, drainage, MEPS, and intrasaccular pressure measurement
was a completion of the celiac trunk with two stent grafts. Preoperative CT, a staged procedure with open aorta at the level of renal and mesenteric arteries, and then completion postoperative with all arteries perfused. Now, what we learned after this.
We may have different methodology. This patient is stable, the reconstruction is well-functioning after 12 months of follow-up, but we should always remember to tailor the procedure to the morphology, it is one of the ways. Thank you very much.
- Great, thanks Jeff. Welcome everyone. I was actually going to more talk about a wish list for ZFEN plus after some discussion with our industry partners. There's still not quite a final lock yet on the final device so due to various reasons we'll go over kind of a
review of the U.S. fenestrated data and then some of the things that I hope are some of the current limitations. This is our personal experience right now since the approval. 159 commercial ZFEN devices.
Still a reasonable proportion of parallel grafting for urgent or challenging cases. I think everybody acknowledges that obviously creating a seal zone above the renal arteries provides more seal for a standard infrarenal strategy. In fact because the U.S. device the instructions for use
call for a four to 14 millimeter infrarenal neck you wind up adding that in addition to the space that's across the renal arteries as well as the seal generally up to the scallop, or if you're building a large fenestration for the SMA, all the way up to the celiac.
Graft diameters from 22 to 36, the 36 millimeter device being on a 22 French system. The remainder of them being on a 20 French system. Remember that in the U.S. that we can only build three of these holes, if you will, and you can only have two maximum of one of the types meaning the general build
is two small fenestrations for the renals and either a scallop or large fenestration for the superior mesenteric artery. The results of the U.S. prospective trial have been presented and published multiple times in the past but basically in the original study
most of them under general anesthesia. Total amount of procedure time about three to four hours. The device implant time about two hours. Technical success achieved in everyone with all visceral vessels patent on the completion run. 30 day mortality excellent, the one problem
was with bowel ischemia. Major adverse events sort of immediately post op also related to bowel ischemia but no conversion, ruptures, or renal function decline. And at pre-discharge CTA all target vessels patent without any type one or junctional endoleaks.
Hospital stay two to three days. The later follow up paper, follow up out to three years with excellent outcomes related to problems with type one or type three endoleaks and the renal outcomes also excellent. Three patients with renal function deterioration.
But, a reasonable number of renal stent exclusions and stenoses which I do believe should be counted against the technology. And the reninterventions needed in a reasonable number of patients. So a primary patency of 81%
on the Capellan Meyer out to five years. When you look at then sort of early post approval outcomes, which is what we would consider more real world studies, when we looked at the first seven or eight sites that had early access right after approval we looked at this data and it turned out much like
what we would all do if we get our hands on newer technology now. More than two thirds, or just under two thirds of patients actually did not meet the recommended anatomic criteria of a four to 14 millimeter infrarenal neck but despite this the 30 day outcomes
compared to the U.S. data. This is a paper that just came out from the University of Indiana. First hundred patients since the ZFEN approval excellent outcomes but again still a reasonable reintervention rate mainly going after these renal branches.
This was our first one, a very sort of standard infrarenal short neck with a scallop and such built. Most of our builds now are with a large fenestration and bilateral renals. So what do we really need? I think in the newer device.
Well I think everybody wants something that's a little smaller access. We've had to use a reasonable number of both endo and open iliac conduits. I still think the angulation makes things difficult. These cases that have the SMA close to the renals
in the current construct do not allow us to build a device that makes it work for that. We've had to come up with various strategies when the SMA is lower than the higher renal. So I think really the future devices we need to work on the wait time, something with better renal branches
and a smaller access. Thanks.
- [Doctor] Thank you Tom and thanks Dr Veith for the invitation to be here again. These are my disclosures, so hypogastric embolization is not benign, patients can develop buttock claudication, higher after bilateral sacrifice, it can be persistent in up to half of patients. Sexual dysfunction can also occur, and we know that
there can be catastrophic complications but fortunately they're relatively rare. So now these are avoidable, we no longer have to coil and cover in many patients and we can preserve internal iliac's with iliac branch devices like you just heard. We had previously published the results of looking from
the pivotal trial, looking at the Gore IBE device with the six month primary end point showing zero aneurysm-related morality, high rates of technical success, 95% patency of the internal iliac limb, no type one or type three endoleaks and 98% freedom from reintervention. Importantly on the side of the iliac branch device, there
was prevention of new-onset of buttock claudication in all patients, and importantly also on the contralateral side in patients with bilateral aneurysms that were sacrificed, the incidents in a prospect of trial of the development of buttock claudication was 28%, confirming the data from those prior series.
And this is in line with the results of EVAR using iliac branch device published by many others showing low rates of mortality, high rates of technical success and also good patency of the devices. In press now we have results with follow-up out through two years, in the Gore IBE trial, we also compared
those findings to outcomes in a real world experience from the great registry, so 98 patients from the pivotal and continued access arm's of the IBE trial and also 92 patients who underwent treatment with the Gore IBE device in the great registry giving us 190 patients with 207 IBE devices implanted.
Follow-up was up to three years, it was an longer mean follow-up in the IDE study with the IBE device. Looking at outcomes between the clinical trial and the real world experience, they were very similar. There was no aneurysm-related mortality, there was no recorded new-onset ipsilateral buttock claudication,
this is all from the IDE trial since we didn't have that information in the great registry, and looking at the incidence of reinterventions, it was similar both in the IDE clinical trial experience and also in the great registry as well. Looking at patency of the internal iliac limb, it was
93.6%, both at 12 months and 24 months in the prospective US IBE pivotall trial and importantly all the internal iliac limb occlusions occurred very early in the experience likely due to technical or anatomic factors. When we look at the incidence of type two endoleaks, we had previously noted there was a very high incidence of
type two endoleaks, 60% at one month, this did tail off a bit over time but it was still 35% at two years. A total of five patients in the pivotal IBE trial had a reintervention for type two endoleak through two years, and despite that high incidence of type two endoleak, overall the incidence of aortic aneurysm sac expansion
of more than five millimeters has been rare and low at two and nine percent at 12 and 24 months, and there's been no expansions of the treated common iliac artery aneurysm sac's at either 12 or 24 months. Freedom from reintervention has been quite good, 90.4% through two years in the trial and most of these
re-interventions were type two endoleaks. We now have some additional data out through three years in about two thirds of the patients we have imaging data available now through three years in the pivotal IBE trial, there have been no additional events, device related events reported since the two year data and through three years
we have no recorded type one or type three endoleaks, no aneurysm ruptures, no incidences of migration, very high rates of patency of the external and internal iliac arteries, good freedom from re-intervention and good freedom from common iliac artery aneurysm sac enlargement. And I think, in line with these findings, the guidelines
now from the SVS are to recommend preservation of the internal iliac arteries when ever present and that's a grade 1A recommendation, thank you.
- Good afternoon to everybody, this is my disclosure. Now our center we have some experience on critical hand ischemia in the last 20 years. We have published some papers, but despite the treatment of everyday, of food ischemia including hand ischemia is not so common. We had a maximum of 200 critical ischemic patients
the majority of them were patient with hemodialysis, then other patients with Buerger's, thoracic outlet syndrome, etcetera. And especially on hemodialysis patients, we concentrate on forearms because we have collected 132 critical ischemic hands.
And essentially, we can divide the pathophysiology of this ischemic. Three causes, first is that the big artery disease of the humeral and below the elbow arteries. The second cause is the small artery disease
of the hand and finger artery. And the third cause is the presence of an arterial fistula. But you can see, that in active ipsillateral arteriovenous fistula was present only 42% of these patients. And the vast majority of the patients
who had critical hand ischemia, there were more concomitant causes to obtain critical hand ischemia. What can we do in these types of patients? First, angioplasty. I want to present you this 50 years old male
with diabetes type 1 on hemodialysis, with previous history of two failed arteriovenous fistula for hemodialysis. The first one was in occluded proximal termino-lateral radiocephalic arteriovenous fistula. So, the radial artery is occluded.
The second one was in the distal latero-terminal arteriovenous fistula, still open but not functioning for hemodialysis. Then, we have a cause of critical hand ischemia, which is the occlusion of the ulnar artery. What to do in a patient like this?
First of all, we have treated this long occlusion of the ulnar artery with drug-coated ballooning. The second was treatment of this field, but still open arteriovenous fistula, embolized with coils. And this is the final result,
you can see how blood flow is going in this huge superficial palmar arch with complete resolution of the ischemia. And the patient obviously healed. The second thing we can do, but on very rarely is a bypass. So, this a patient with multiple gangrene amputations.
So, he came to our cath lab with an indication to the amputation of the hand. The radial artery is totally occluded, it's occluded here, the ulnar artery is totally occluded. I tried to open the radial artery, but I understood that in the past someone has done
a termino-terminal radio-cephalic arteriovenous fistula. So after cutting, the two ends of the radial artery was separated. So, we decided to do a bypass, I think that is one of the shortest bypass in the world. Generally, I'm not a vascular surgeon
but generally vascular surgeons fight for the longest bypass and not for the shortest one. I don't know if there is some race somewhere. The patient was obviously able to heal completely. Thoracic sympathectomy. I have not considered this option in the past,
but this was a patient that was very important for me. 47 years old female, multiple myeloma with amyloidosis. Everything was occluded, I was never able to see a vessel in the fingers. The first time I made this angioplasty,
I was very happy because the patient was happy, no more pain. We were able to amputate this finger. Everything was open after three months. But in the subsequent year, the situation was traumatic. Every four or five months,
every artery was totally occluded. So, I repeated a lot of angioplasty, lot of amputations. At the end it was impossible to continue. After four years, I decided to do something, or an amputation at the end. We tried to do endoscopic thoracic sympathectomy.
There is a very few number of this, or little to regard in this type of approach. But infected, no more pain, healing. And after six years, the patient is still completely asymptomatic. Unbelievable.
And finally, the renal transplant. 36 years old female, type one diabetes, hemodialysis. It was in 2009, I was absolutely embarrassed that I tried to do something in the limbs, inferior limbs in the hand.
Everything was calcified. At the end, we continued with fingers amputation, a Chopart amputation on one side and below the knee major amputation. Despite this dramatic clinical stage, she got a double kidney and pancreas transplant on 2010.
And then, she healed completely. Today she is 45 years old, this summer walking in the mountain. She sent to me a message, "the new leg prostheses are formidable". She's driving a car, totally independent,
active life, working. So, the transplant was able to stop this calcification, this small artery disease which was devastating. So, patients with critical high ischemia have different pathophysiology and different underlying diseases.
Don't give up and try to find for everyone the proper solution. Thank you very much for your attention.
- Thank you so much. I have no disclosures. These guidelines were published a year ago and they are open access. You can download the PDF and you can also download the app and the app was launched two months ago
and four of the ESVS guidelines are in that app. As you see, we had three American co-authors of this document, so we have very high expertise that we managed to gather.
Now the ESVS Mesenteric Guidelines have all conditions in one document because it's not always obvious if it's acute, chronic, acute-on-chron if it's arteri
if there's an underlying aneurysm or a dissection. And we thought it a benefit for the clinician to have all in one single document. It's 51 pages, 64 recommendations, more than 300 references and we use the
ESC grading system. As you will understand, it's impossible to describe this document in four minutes but I will give you some highlights regarding one of the chapters, the Acute arterial mesenteric ischaemia chapter.
We have four recommendations on how to diagnose this condition. We found that D-dimer is highly sensitive so that a normal D-dimer value excludes the condition but it's also unfortunately unspecific. There's a common misconception that lactate is
useful in this situation. Lactate becomes elevated very late when the patient is dying. It's not a good test for diagnosing acute mesenteric ischaemia earlier. And this is a strong recommendation against that.
We also ask everyone uses the CTA angiography these days and that is of course the mainstay of diagnoses as you can see on this image. Regarding treatment, we found that in patients with acute mesenteric arterial ischaemia open or endovascular revascularisation
should preferably be done before bowel surgery. This is of course an important strategic recommendation when we work together with general surgeons. We also concluded that completion imaging is important. And this is maybe one of the reasons why endovascular repair tends to do better than
open repair in these patients. There was no other better way of judging the bowel viability than clinical judgment a no-brainer is that these patients need antibiotics and it's also a strong recommendation to do second look laparotomoy.
We found that endovascular treatment is first therapy if you suspect thrombotic occlusion. They had better survival than the open repair, where as in the embolic situation, we found no difference in outcome.
So you can do both open or endo for embolus, like in this 85 year old man from Uppsala where we did a thrombus, or the embolus aspiration. Regarding follow up, we found that it was beneficial to do imaging follow-up after stenting, and also secondary prevention is important.
So in conclusion, ladies and gentlemen, the ESVS Guidelines can be downloaded freely. There are lots of recommendations regarding diagnosis, treatment, and follow-up. And they are most useful when the diagnosis is difficult and when indication for treatment is less obvious.
Please read the other chapters, too and please come to Hamburg next year for the ESVS meeting. Thank You
- Thank you, Mark. I appreciate the opportunity to be here. These are my disclosures. Dr. Eagleton is college of the Cleveland Clinic of nicely describe their experience of over 350 patients with thoracoabdominal aneurysms, using branch-standard graphs.
This is fantastic data and rivals even the best data available from Open Repair. The Cook T-Branch, which is not available in the United States, also has excellent technical success. Although is not really applicable to almost half the patients
and is not available for us in the United States. What options do we have for endo TAAA repair that's off-label? Dr. Labato's very eloquently described his technique, so I'm going into that anymore. This has been widely adopted by ourselves,
as well as many other complex aortic programs around the country, with excellent results. In our own experience, unfortunately, using that retrograde renal bypass, we've had about a 50% renal stent failure. So, we've sort of abandoned that.
There are a number of other techniques that have become available and described in the literature. This was a paper from the early 2000s by Dr.Kasirajan, using two bifurcated gore graft up in the thoracic aorta and sandwiching those,
snorkeling those, and then extending branches into the visceral vessels and down into the aortic bifurcation. Dr. Starnes and his colleagues have popularized physician modified endografts in the United States, using an IDE and this is again excellent results,
low reintervention rates, great branch patency, and aneurysm regression. But again, complex requires really being able to take CT data and transcribe that onto an endograft. My colleague, Dr. Paludetto, in Brazil, has described a technique where he sutures branches
onto the contralateral limb of a gore graft and then uses those with proximal access to extend into the visceral branches. And then the ipsilateral side is extended using another bifurcated graft. In our experience, we have adopted
some parts of all of these techniques, and what we describe as our octopus technique, this is placing a gore graft up into the thoracic aorta, if that's applicable size, otherwise we place a TVAR device and then marry the two. Three sheaths are then advanced through a conduit,
placed in the left axillary artery, and then using viabahn stent grafts through the contralateral limb. Oversizing these a little bit, you really need to have at least two sixes and an eight or two sevens and an eight, to get good seal.
And you get a nice sort of pie-shaped seal in the contralateral gate. This is a CT scan, following one of these procedures. In our experience, we've done 14 of these cases. 35% of these patients were symptomatic, with three or four vessel approach,
so the celiac artery was sacrificed in six patients. If you can put a snorkel alongside the proximal fixation, to include the celiac artery, if necessary. Two cases are extended all the way to left subclavian artery, that do require a lot of radiation and contrast,
but the success rate was been good. We did have two patients that died, unfortunately, from mesenteric ischemia. We've had no spinal cord ischemia. Two early leaks within the contralateral gate, we treated with embolization.
And two late leaks, one from distal attachment site that was easily treated. Our branch patency is 96%. If you look at all the world literature, on all these techniques, fantistrated branch, physician modified graft, it's all over the place.
Spinal cord ischemia rates ranges from zero to 30%, renal injury up to 15%, 39 mortality, up to 20%. And then some of these acute rupture cases, mortality is as high as 100%. So what do we do? So this is another off-label, physician modified graft,
this is the Pat Kelly device, and I think Pat's here and will be talking about his device later. We've now instituted a IDE, using the Valiant Thoracoabdominal Device, it's available in six, was six,
and now including Mass General will be seven sites around the country. They key features are proximal fixation with a Suleman Thoracic Device with a visceral manifold. We use then endo branches and distal modified endurant. Each site is a prospective, single-center,
non randomized, multi arm or single arm study. All IDE sites are using similar protocols, so we can potentially pull this data. And then expanded arm includes patients that are emergent or renal insufficiency. We've done about 32 cases so far,
I think we're up to 39. This is the last reported data. Type one, type two, and type three, we're excluding type fours. This is the data about the procedure. Majority of these patients do get spinal drains,
technical success is 94% overall. Primary arm 89%, 100% in the extended arm. Overall three patients have died, which is 9%. Paraplegia, also 9%. What do we have? Endovascular techniques are available, off-label.
Procedures may be all we have in this country for the majority of centers. While we wait broader availability of fenestrated grafts, this is the only solution we have. Thank you.
- Thank you very much, Dr. Veith, and thank you to you and the organizing committee for inviting me to participate again this year in, really, the premiere vascular meeting. This morning, I'd like to talk about the contemporary management of carotid artery aneurysms. These are my disclosures.
Extracranial carotid artery aneurysms and pseudoaneurysms may result from a variety of causes, including trauma, fibromuscular dysplasia, atherosclerosis. They're associated with dissection, connective tissue disorders, mycotic aneurysms associated with infection.
We see patch aneurysms from prior carotid endarterectomy, as well as aneurysms associated with radiation, and those that occur spontaneously. Sequelae of these aneurysms are often distal embolization, potential for thrombosis, some patients experience compressive symptoms, and rupture may occur as well.
Treatment has traditionally been through open surgical repair, but there have been advances in endovascular treatments, including covered stents, woven stents, such as the pipeline stent in size-appropriate cases, bare stents with or without adjunctive coil embolization.
Open surgical repair has been time tested and it's proven to be very effective, but there are potential morbidities associated with challenges or surgical exposure, particularly in patients with prior surgery or radiation and those with anatomically-challenging lesions.
A very definitive review of this has been conducted by the surgeons at the Mayo Clinic, including Drs. Money, Bower, and Fowl, and they have described the treatment of 141 aneurysms in 132 patients. In the evolution of treatment with endovascular techniques, covered stents have been employed.
These eliminate aneurysm and pseudoaneurysm perfusion completely and immediately after deployment, but there have been reports of delayed thrombosis of these covered stents when they've been deployed in the cervical distribution. This is a patient of ours who has a large patch aneurysm, nearly four centimeters in size.
If you look on the CAT scan you'll see there's very limited, essentially no overlying soft tissues as a result of the previous radical neck dissection. In this case, we'd elected to use a covered stent to achieve exclusion of this patch aneurysm, and then used a bare metal stent distally to augment the treatment itself.
Our therapies progressed to the use of bare metal stents with associated coil embolization so-called stent, assisted coil embolization. As you can see, there are two sequential, very large, pseudoaneurysms of the internal carotid artery. Here's the carotid bifurcation.
Here, I hope you can see between these green arrows, is the stent that's been deployed. We use closed cell stents typically for these applications, and we can use a microcatheter cannulate that pseudoaneurysm and deploy large neuro-embolic coils to promote flow of cessation.
When we follow up with these patients, here's this patient's one-month post-operative duplex ultrasound, there's no flow in the pseudoaneurysm, and excellent flow in the internal carotid artery without stenosis. We've then progressed to the use of overlapping closed cell stents, and in doing so,
hoped to sort of simulate the pipeline woven stent configuration but have greater applicability in terms of diameter of the internal carotid. Here, you can see this internal carotid artery spontaneous pseudoaneurysm. We then go ahead and bring our initial stent into position
across the origin of the pseudoaneurysm. Here's after initial stent deployment on this static image. Here, after our second stent deployment, you can see very limited static flow within the pseudoaneurysm itself, and that's evidenced by, after the flowed out of the internal carotid artery,
there's still residual contrast within the pseudoanerusym. Here are the individual characteristics of the patients that we've treated using endovascular techniques. To summarize those data, the mean duration of follow up for these patients is 331 days.
But we have followed one patient out to eight years. The study's limited by the relatively small number of patients and the limited duration of follow up in these patients. But our technical success has been 100%, in terms of being able to deploy the endovascular
techniques, and maintain patency. We've had no patients who've experienced neurologic sequelae, including no strokes or TIAs. There've been no cases in which the aneurysm has expanded, in most cases, the aneurysm itself regresses and there's been no flow within those aneurysms or pseudoaneurysms.
Finally, we have been able to maintain 100% patency in these patients, as monitored using our standard follow up protocol with duplex ultrasound being performed every three months for the first year, and annually thereafter. In conclusion, extracranial carotid artery aneurysms and pseudoaneurysms may be treated effectively
using standard open techniques. However, surgical exposure and perioperative morbidity may present challenges for open repair. Endovascular approaches to aneurysm and pseudoaneurysm treatment have evolved progressively. The preliminary results of our analysis with mid-term
follow up suggest that these techniques are effective and durable, with limited procedural morbidity. Thank you very much.
- Thank you Mr. Chairman. Ladies and gentleman, first of all, I would like to thank Dr. Veith for the honor of the podium. Fenestrated and branched stent graft are becoming a widespread use in the treatment of thoracoabdominal
and pararenal aortic aneurysms. Nevertheless, the risk of reinterventions during the follow-up of these procedures is not negligible. The Mayo Clinic group has recently proposed this classification for endoleaks
after FEVAR and BEVAR, that takes into account all the potential sources of aneurysm sac reperfusion after stent graft implant. If we look at the published data, the reported reintervention rate ranges between three and 25% of cases.
So this is still an open issue. We started our experience with fenestrated and branched stent grafts in January 2016, with 29 patients treated so far, for thoracoabdominal and pararenal/juxtarenal aortic aneurysms. We report an elective mortality rate of 7.7%.
That is significantly higher in urgent settings. We had two cases of transient paraparesis and both of them recovered, and two cases of complete paraplegia after urgent procedures, and both of them died. This is the surveillance protocol we applied
to the 25 patients that survived the first operation. As you can see here, we used to do a CT scan prior to discharge, and then again at three and 12 months after the intervention, and yearly thereafter, and according to our experience
there is no room for ultrasound examination in the follow-up of these procedures. We report five reinterventions according for 20% of cases. All of them were due to endoleaks and were fixed with bridging stent relining,
or embolization in case of type II, with no complications, no mortality. I'm going to show you a couple of cases from our series. A 66 years old man, a very complex surgical history. In 2005 he underwent open repair of descending thoracic aneurysm.
In 2009, a surgical debranching of visceral vessels followed by TEVAR for a type III thoracoabdominal aortic aneurysms. In 2016, the implant of a tube fenestrated stent-graft to fix a distal type I endoleak. And two years later the patient was readmitted
for a type II endoleak with aneurysm growth of more than one centimeter. This is the preoperative CT scan, and you see now the type II endoleak that comes from a left gastric artery that independently arises from the aneurysm sac.
This is the endoleak route that starts from a branch of the hepatic artery with retrograde flow into the left gastric artery, and then into the aneurysm sac. We approached this case from below through the fenestration for the SMA and the celiac trunk,
and here on the left side you see the superselective catheterization of the branch of the hepatic artery, and on the right side the microcatheter that has reached the nidus of the endoleak. We then embolized with onyx the endoleak
and the feeding vessel, and this is the nice final result in two different angiographic projections. Another case, a 76 years old man. In 2008, open repair for a AAA and right common iliac aneurysm.
Eight years later, the implant of a T-branch stent graft for a recurrent type IV thoracoabdominal aneurysm. And one year later, the patient was admitted again for a type IIIc endoleak, plus aneurysm of the left common iliac artery. This is the CT scan of this patient.
You will see here the endoleak at the level of the left renal branch here, and the aneurysm of the left common iliac just below the stent graft. We first treated the iliac aneurysm implanting an iliac branched device on the left side,
so preserving the left hypogastric artery. And in the same operation, from a bowl, we catheterized the left renal branch and fixed the endoleak that you see on the left side, with a total stent relining, with a nice final result on the right side.
And this is the CT scan follow-up one year after the reintervention. No endoleak at the level of the left renal branch, and nice exclusion of the left common iliac aneurysm. In conclusion, ladies and gentlemen, the risk of type I endoleak after FEVAR and BEVAR
is very low when the repair is planning with an adequate proximal sealing zone as we heard before from Professor Verhoeven. Much of reinterventions are due to type II and III endoleaks that can be treated by embolization or stent reinforcement. Last, but not least, the strict follow-up program
with CT scan is of paramount importance after these procedures. I thank you very much for your attention.
- [Dr. Lobato] Thank you. I have no disclosure. To give you some tips about Sandwich Technique. Of course, the first step is to have a proximal neck. We need to have at least 15 millimeter in length and no bigger than 40 millimeter in diameter, and your stent graft should finish
at one or two centimeters above the celiac trunk to avoid using longer self-expandable covered stent. That's why we needed to finish as close as possible to the celiac trunk. When you're talking about Type 1, Type 2, or Type 3 thoracoabdominal aneurysm
we need to revascularize all four visceral arteries, so our option is to come from above from the left axillary artery or the right brachial artery. Three cannulations. You cannulate the celiac trunk,
you cannulate the SMA, and one renal artery. Then we apply the bifurcated stent graft in front, contralaterally I cannulate the left or right renal, it depends on the best way to cannulate that. In this moment,
you already have your long introducer inside of the visceral arteries and also now from the femoral one another introducer and the self-expandable covered stent. That's my option,
self-expandable covered stent because it's longer. So if you use a bare metal covered stent, it means you need two or more stent graft for that. I keep the self-expandable, the sacs inside of the visceral artery
and use the bridge thoracic stent graft now. These thoracic stent graft must have 30% oversizing. The key point, that you need to create the five centimeters overlapping between the two thoracic stent grafts in the middle, from above the three sacs,
and from below the renal sacs also. You need to have 5 centimeters for that. Then the point is to apply the stent graft, the thoracic stent graft, you use a latex balloon to accommodate it. These stent grafts in between the sacs of that.
This is very important. Do not deploy that moment the self-expandable covered stent. After I use the latex balloon, so in this moment, we deploy the self-expandable covered stent now
inside the visceral arteries. It's not mandatory anymore to use a self-expandable covered stent. Bare metal one as well, the angioplasty for that. Then you deploy the contralateral limb.
Just to show how it looks like, the Sandwich Technique, you see now the 42 millimeter stent graft, and the 8 millimeter self-expandable covered stent in the visceral arteries and one 6 millimeter in the renal artery.
How it looks, the lumen, for that Sandwich. It's very important for that. For this case, this aorta, the healthy aorta has 22 millimeter, so it's impossible. That's a precaution.
It's impossible to do a Sandwich in this case because you have no lumen. Let's remind, we've used three stent graft, two covered stent inside that. So you must precaution about the lumen.
The other point, I avoid now to use bare metal self-expandable stent. I have fracture when I use the self-expandable covered stent inside that bare metal self-expandable stent. I got a fracture in the part inside the renal artery.
Not together with the covered stent, but outside the covered stent. If you needed to do that, you need to choose inside of the covered stent. In the other point, you need to avoid a cross over
between the self expandable covered stent to the other one. So that's another key that you can use with your introducer and make sure that you do not make this movement. The other point, I do not like as much the bare metal stent, I got some fracture in the renal arteries.
As you can see here, preimposed post-operative area. It's a six month post-operative fracture. Another point is you need to deploy your covered stent at least two centimeters inside of the visceral artery. This one was less than two centimeters,
so in the post-operative six month you've got a migration in the Type 2 endoleak here, as you can see. So you must prepare to use that. Another precaution is about subclavial occlusion, extra-anatomic bypass,
no LIMA bypass, unilateral or bilateral hypogastric artery occlusion, shaggy aorta, and concomitant aortic arch aneurysm. In conclusion, ladies and gentlemen, the Sandwich Technique facilitates safe
and effective thoracoabdominal exclusion, and some precautions must be taken to sustain the durability in midterm follow-up. Thank you very much.
- Thank you very much for the opportunity to speak carbon dioxide angiography, which is one of my favorite topics and today I will like to talk to you about the value of CO2 angiography for abdominal and pelvic trauma and why and how to use carbon dioxide angiography with massive bleeding and when to supplement CO2 with iodinated contrast.
Disclosures, none. The value of CO2 angiography, what are the advantages perhaps? Carbon dioxide is non-allergic and non-nephrotoxic contrast agent, meaning CO2 is the only proven safe contrast in patients with a contrast allergy and the renal failure.
Carbon dioxide is very highly soluble (20 to 30 times more soluble than oxygen). It's very low viscosity, which is a very unique physical property that you can take advantage of it in doing angiography and CO2 is 1/400 iodinated contrast in viscosity.
Because of low viscosity, now we can use smaller catheter, like a micro-catheter, coaxially to the angiogram using end hole catheter. You do not need five hole catheter such as Pigtail. Also, because of low viscosity, you can detect bleeding much more efficiently.
It demonstrates to the aneurysm and arteriovenous fistula. The other interesting part of the CO2 when you inject in the vessel the CO2 basically refluxes back so you can see the more central vessel. In other words, when you inject contrast, you see only forward vessel, whereas when you inject CO2,
you do a pass with not only peripheral vessels and also see more central vessels. So basically you see the vessels around the lesions and you can use unlimited volumes of CO2 if you separate two to three minutes because CO2 is exhaled by the respirations
so basically you can inject large volumes particularly when you have long prolonged procedures, and most importantly, CO2 is very inexpensive. Where there are basically two methods that will deliver CO2. One is the plastic bag system which you basically fill up with a CO2 tank three times and then empty three times
and keep the fourth time and then you connect to the delivery system and basically closest inject for DSA. The other devices, the CO2mmander with the angio assist, which I saw in the booth outside. That's FDA approved for CO2 injections and is very convenient to use.
It's called CO2mmander. So, most of the CO2 angios can be done with end hole catheter. So basically you eliminate the need for pigtail. You can use any of these cobra catheters, shepherd hook and the Simmons.
If you look at this image in the Levitor study with vascular model, when you inject end hole catheter when the CO2 exits from the tip of catheter, it forms very homogenous bolus, displaces the blood because you're imaging the blood vessel by displacing blood with contrast is mixed with blood, therefore as CO2
travels distally it maintains the CO2 density whereas contrast dilutes and lose the densities. So we recommend end hole catheter. So that means you can do an arteriogram with end hole catheter and then do a select arteriogram. You don't need to replace the pigtail
for selective injection following your aortographies. Here's the basic techniques: Now when you do CO2 angiogram, trauma patient, abdominal/pelvic traumas, start with CO2 aortography. You'll be surprised, you'll see many of those bleeding on aortogram, and also you can repeat, if necessary,
with CO2 at the multiple different levels like, celiac, renal, or aortic bifurcation but be sure to inject below diaphragm. Do not go above diaphragm, for example, thoracic aorta coronary, and brachial, and the subclavian if you inject CO2, you'll have some serious problems.
So stay below the diaphragm as an arterial contrast. Selective injection iodinated contrast for a road map. We like to do super selective arteriogram for embolization et cetera. Then use a contrast to get anomalies. Super selective injection with iodinated contrast
before embolization if there's no bleeding then repeat with CO2 because of low viscocity and also explosion of the gas you will often see the bleeding. That makes it more comfortable before embolization. Here is a splenic trauma patient.
CO2 is injected into the aorta at the level of the celiac access. Now you see the extra vascularization from the low polar spleen, then you catheterize celiac access of the veins. You microcatheter in the distal splenic arteries
and inject the contrast. Oops, there's no bleeding. Make you very uncomfortable for embolizations. We always like to see the actual vascularization before place particle or coils. At that time you can inject CO2 and you can see
actual vascularization and make you more comfortable before embolization. You can inject CO2, the selective injection like in here in a patient with the splenic trauma. The celiac injection of CO2 shows the growth, laceration splenic with extra vascularization with the gas.
There's multiple small, little collection. We call this Starry Night by Van Gogh. That means malpighian marginal sinus with stagnation with the CO2 gives multiple globular appearance of the stars called Starry Night.
You can see the early filling of the portal vein because of disruption of the intrasplenic microvascular structures. Now you see the splenic vein. Normally, you shouldn't see splenic vein while following CO2 injections.
This is a case of the liver traumas. Because the liver is a little more anterior the celiac that is coming off of the anterior aspect of the aorta, therefore, CO2 likes to go there because of buoyancy so we take advantage of buoyancy. Now you see the rupture here in this liver
with following the aortic injections then you inject contrast in the celiac axis to get road map so you can travel through this torus anatomy for embolizations for the road map for with contrast. This patient with elaston loss
with ruptured venal arteries, massive bleeding from many renal rupture with retro peritoneal bleeding with CO2 and aortic injection and then you inject contrast into renal artery and coil embolization but I think the stent is very dangerous in a patient with elaston loss.
We want to really separate the renal artery. Then you're basically at the mercy of the bleeding. So we like a very soft coil but basically coil the entire renal arteries. That was done. - Thank you very much.
- Time is over already? - Yeah. - Oh, OK. Let's finish up. Arteriogram and we inject CO2 contrast twice. Here's the final conclusions.
CO2 is a valuable imaging modality for abdominal and pelvic trauma. Start with CO2 aortography, if indicated. Repeat injections at multiple levels below diaphragm and selective injection road map with contrast. The last advice fo
t air contamination during the CO2 angiograms. Thank you.
- Thanks Dr. Weaver. Thank you Dr. Reed for the invitation, once again, to this great meeting. These are my disclosures. So, open surgical repair of descending aortic arch disease still carries some significant morbidity and mortality.
And obviously TEVAR as we have mentioned in many of the presentations has become the treatment of choice for appropriate thoracic lesions, but still has some significant limitations of seal in the aortic arch and more techniques are being developed to address that.
Right now, we also need to cover the left subclavian artery and encroach or cover the left common carotid artery for optimal seal, if that's the area that we're trying to address. So zone 2, which is the one that's,
it is most commonly used as seal for the aortic arch requires accurate device deployment to maximize the seal and really avoid ultimately, coverage of the left common carotid artery and have to address it as an emergency. Seal, in many of these cases is not maximized
due to the concern of occlusion of the left common carotid artery and many of the devices are deployed without obtaining maximum seal in that particular area. Failure of accurate deployment often leads to a type IA endoleak or inadvertent coverage
of the left common carotid artery which can become a significant problem. The most common hybrid procedures in this group of patients include the use of TEVAR, a carotid-subclavian reconstruction and left common carotid artery stenting,
which is hopefully mostly planned, but many of the times, especially when you're starting, it may be completely unplanned. The left common carotid chimney has been increasingly used to obtain a better seal
in this particular group of patients with challenging arches, but there's still significant concerns, including patients having super-vascular complications, stroke, Type A retrograde dissections and a persistent Type IA endoleak
which can be very challenging to be able to correct. There's limited data to discuss this specific topic, but some of the recent publications included a series of 11 to 13 years of treatment with a variety of chimneys.
And these publications suggest that the left common carotid chimneys are the most commonly used chimneys in the aortic arch, being used 76% to 89% of the time in these series. We can also look at these and the technical success
is very good. Mortality's very low. The stroke rate is quite variable depending on the series and chimney patency's very good. But we still have a relatively high persistent
Type IA endoleak on these procedures. So what can we do to try to improve the results that we have? And some of these techniques are clearly applicable for elective or emergency procedures. In the elective setting,
an open left carotid access and subclavian access can be obtained via a supraclavicular approach. And then a subclavian transposition or a carotid-subclavian bypass can be performed in preparation for the endovascular repair. Following that reconstruction,
retrograde access to left common carotid artery can be very helpful with a 7 French sheath and this can be used for diagnostic and therapeutic purposes at the same time. The 7 French sheath can easily accommodate most of the available covered and uncovered
balloon expandable stents if the situation arises that it's necessary. Alignment of the TEVAR is critical with maximum seal and accurate placement of the TEVAR at this location is paramount to be able to have a good result.
At that point, the left common carotid artery chimney can be deployed under control of the left common carotid artery. To avoid any embolization, the carotid can be flushed, primary repaired, and the subclavian can be addressed
if there is concern of a persistent retrograde leak with embolization with a plug or other devices. The order can be changed for the procedure to be able to be done emergently as it is in this 46 year old policeman with hypertension and a ruptured thoracic aneurism.
The patient had the left common carotid access first, the device deployed appropriately, and the carotid-subclavian bypass performed in a more elective fashion after the rupture had been addressed. So, in conclusion, carotid chimney's and TEVAR
combination is a frequently used to obtain additional seal on the aortic arch, with pretty good results. Early retrograde left common carotid access allows safe TEVAR deployment with maximum seal,
and the procedure can be safely performed with low morbidity and mortality if we select the patients appropriately. Thank you very much.
- Thank you. Historically, common femoral endarterectomy is a safe procedure. In this quick publication that we did several years ago, showed a 1.5% 30 day mortality rate. Morbidity included 6.3% superficial surgical site infection.
Other major morbidity was pretty low. High-risk patients we identified as those that were functionally dependent, dyspnea, obesity, steroid use, and diabetes. A study from Massachusetts General Hospital their experience showed 100% technical success.
Length of stay was three days. Primary patency of five years at 91% and assisted primary patency at five years 100%. Very little perioperative morbidity and mortality. As you know, open treatment has been the standard of care
over time the goal standard for a common femoral disease, traditionally it's been thought of as a no stent zone. However, there are increased interventions of the common femoral and deep femoral arteries. This is a picture that shows inflection point there.
Why people are concerned about placing stents there. Here's a picture of atherectomy. Irritational atherectomy, the common femoral artery. Here's another image example of a rotational atherectomy, of the common femoral artery.
And here's an image of a stent there, going across the stent there. This is a case I had of potential option for stenting the common femoral artery large (mumbles) of the hematoma from the cardiologist. It was easily fixed
with a 2.5 length BioBond. Which I thought would have very little deformability. (mumbles) was so short in the area there. This is another example of a complete blow out of the common femoral artery. Something that was much better
treated with a stent that I thought over here. What's the data on the stenting of the endovascular of the common femoral arteries interventions? So, there mostly small single centers. What is the retrospective view of 40 cases?
That shows a restenosis rate of 19.5% at 12 months. Revascularization 14.1 % at 12 months. Another one by Dr. Mehta shows restenosis was observed in 20% of the patients and 10% underwent open revision. A case from Dr. Calligaro using cover stents
shows very good primary patency. We sought to use Vascular Quality Initiative to look at endovascular intervention of the common femoral artery. As you can see here, we've identified a thousand patients that have common femoral interventions, with or without,
deep femoral artery interventions. Indications were mostly for claudication. Interventions include three-quarters having angioplasty, 35% having a stent, and 20% almost having atherectomy. Overall technical success was high, a 91%.
Thirty day mortality was exactly the same as in this clip data for open repair 1.6%. Complications were mostly access site hematoma with a low amount distal embolization had previously reported. Single center was up to 4%.
Overall, our freedom for patency or loss or death was 83% at one year. Predicted mostly by tissue loss and case urgency. Re-intervention free survival was 85% at one year, which does notably include stent as independent risk factor for this.
Amputation free survival was 93% at one year, which factors here, but also stent was predictive of amputation. Overall, we concluded that patency is lower than historical common femoral interventions. Mortality was pretty much exactly the same
that has been reported previously. And long term analysis is needed to access durability. There's also a study from France looking at randomizing stenting versus open repair of the common femoral artery. And who needs to get through it quickly?
More or less it showed no difference in outcomes. No different in AVIs. Higher morbidity in the open group most (mumbles) superficial surgical wound infections and (mumbles). The one thing that has hit in the text of the article
a group of mostly (mumbles) was one patient had a major amputation despite having a patent common femoral artery stent. There's no real follow up this, no details of this, I would just caution of both this and VQI paper showing increased risk amputation with stenting.
- Thank you again to Dr. Veith for the kind invitation. This is my disclosures. Open thoracic conversion is an increasing problem. Jose Jucadel speak two years ago in my congress in Milano showing the number of obstruction increase. The my experience in Milano in 25 years, we did global number of 2400 operation for
arch, descending thoracic artery, and thoracoabdominal and particularly more than 1000 open thoracoabdominal. And you have on this number, a total of 206 reintervention after TEVAR in particular for our center 84 patients and 9.8% after treatment.
There are different type of reintervention Endo Relining, Open conversion, and hybrid approach. Today we speak about open conversion. Why open conversion? Open conversion because sometimes the patients are young or fit, for an unstable condition and emergency,
infection of fistula, no proximal neck, and some anatomical barrier like MFM and PETTICOAT. And this is the first case, it's a patient with a dissection with multitreatment a young patient you see acute type B dissection treated in emergency for impending rupture
with three Gore TAG and from left subclavian artery to the super mesenteric artery covering the celiac trunk. Five month later you see "home-made" occluder for false lumen perfusion, but one month later, still perfusion you see a large perfusion of the false lumen with the sac expansion and pain.
So you decide to open the patient with the thoracofemoral approach with a thoracoabdominal operation, you see the proximal clamping opening on the aorta and you see the removing of the prosthesis and partial graft excision near to the neck
of the aneurysm for preparing the anastamosis The anastamosis with a triple-layer technique with a strip of felt and false lumen thrombus removal you see the normal distal and the occlusal false lumen device removal. You start with re-implantation of the single vessel
with complete left renal artery re-implantation of the true vessel. And you see the final result. This is another case, conversion of the patient after PETTICOAT. This is a patient with Marfan syndrome
in 2015 TVAR and PETTICOAT for acute type B dissection and enlargement in the next two years of thoracic and abdominal aorta. So decide for open conversion. You can see here through thoracofemoral operotomy the petticoat on the serosa of the aorta
and you see the stent complete removal after acute declamping and you see visceral renal perfusion and endartherectomy of the petticoat. Perfusion through the PETTICOAT and you see a large endartherectomy of the old PETTICOAT
and this intima-media of the aorta. And here the final result. Our definitive result, we performed a total of 81 open conversions with a mortality of 13%. Major morbidity with respiratory, renal, and parapalegia 7%. And the result is strictly dependent
from the kind of conversion. You see an indication to conversion, in endoleak, you have 6% mortality at one month, for endograft migration and failure 12% mortality, for retrograde dissection 33% mortality, for infection and fistula 30% mortality.
So in conclusion, Mr. Chairman, ladies and gentlemen, I think that close follow up after TEVAR is more and more necessary. Open conversion is always a technical challenge, acceptable in high volume centers, and increased mortality, my experience is due mainly
to retrograde dissection and infection. Thanks for attention.
- Thank you for the invitation to discuss suprarenal bare stent fixation. Here are my disclosure. Aneurismal over graft extension is a part of the natural evolution and the natural history of this degenerative disease, and it could be extended to the celiac aorta
and the common iliac, as well. Regarding the extension to the celiac aorta, we have to consider the infrarenal aorta status, when we want to correct that, and mainly the lengths in between renal artery and the bifurcation of the previously implanted graft,
but also the quality of the access route from below. Most importantly is juxtarenal status, with or without bare stent, and we have nine cases of each. The way to correct this kind of failure is the use of chimney,
when fenistrated graft are not usable. And, the secondary chimney celiac extension, we have 18 cases, when there is a long aortic segment longer than 50 mm, we use a combination of a non-bare stent cuff, associated with balloon-expandable covered parallel stents.
And, when there is a short aortic segment, less than 50 mm, or a difficult access, we use an EVAS device, associated, the same way, with balloon-expandable parallel stents. When the juxtarenal aorta is free of bare stent, it's quite easy to place a wire and stents,
and there is no major contrast in between the different components of the chimney, whatever it is, a cuff extension or the use of an EVAS. It's quite different to when there is, when we have to perform a renal stenting over a bare stent, and you can see that we have to develop tricks
to stabilize a wire into the renal stent by aortic balloon, or by a renal balloon, or renal filter, but this kind of tricks are not working very well. And, we had, in some cases, the need for using push-up procedures, which means that we are exerting forces
onto the delivery system and there's a parallel stent, and that lead to compression in between the different components of this chimney. And, in addition, when there is a bare stent previously implanted, there are forces and there is room
for gutter and that's the way to get type 1 Endoleak. And, it's more difficult when the bare stent is creating a stenosis on the ostium of the renal artery, and we had here to place a stent, a bare stent, for angioplasties and to go to a push-up procedures, before implanting the endoaortic graft
and you can see that there is a lot of contrast, onto this renal stent. When there is a bare stent, there is a slight, the operating time is longer, and one type A Endoleak
more in the bare-stent population of patient but we have one occlusion stent on the non-bare stent group. Endoleak could be treated by embolization into the gutter. But, as we want to avoid this kind of difficult procedures, we use a classification,
based on the evolution profile of the aneurysm. When the neck are safe, we use EVAS to prevent type 2 Endoleak. When the neck is cylindrical, but slightly disease, we use a bifurcated graft, with infrarenal fixation. When the neck is short or when there is no neck,
we use four fenestrated graft, or tri-chimney procedures, and when there is a celiac aneurysm, we use thoracoabdominal reconstruction, using a thoracic segment, in addition with four-fenestrated graft, or a thoracic branch device.
Then, to conclude, the bare stent doesn't prevent the evolution of the aneurysmal disease, that means that we have to reconsider the use of endoaortic graft, with bare stent suprarenal fixation, just to anticipate what could happen during the evolution and the ability to perform
a secondary device extension. And thank you for your attention.
- So Beyond Vascular procedures, I guess we've conquered all the vascular procedures, now we're going to conquer the world, so let me take a little bit of time to say that these are my conflicts, while doing that, I think it's important that we encourage people to access the hybrid rooms,
It's much more important that the tar-verse done in the Hybrid Room, rather than moving on to the CAT labs, so we have some idea basically of what's going on. That certainly compresses the Hybrid Room availability, but you can't argue for more resources
if the Hybrid Room is running half-empty for example, the only way you get it is by opening this up and so things like laser lead extractions or tar-verse are predominantly still done basically in our hybrid rooms, and we try to make access for them. I don't need to go through this,
you've now think that Doctor Shirttail made a convincing argument for 3D imaging and 3D acquisition. I think the fundamental next revolution in surgery, Every subspecialty is the availability of 3D imaging in the operating room.
We have lead the way in that in vascular surgery, but you think how this could revolutionize urology, general surgery, neurosurgery, and so I think it's very important that we battle for imaging control. Don't give your administration the idea that
you're going to settle for a C-arm, that's the beginning of the end if you do that, this okay to augment use C-arms to augment your practice, but if you're a finishing fellow, you make sure you go to a place that's going to give you access to full hybrid room,
otherwise, you are the subservient imagers compared to radiologists and cardiologists. We need that access to this high quality room. And the new buzzword you're going to hear about is Multi Modality Imaging Suites, this combination of imaging suites that are
being put together, top left deserves with MR, we think MR is the cardiovascular imaging modality of the future, there's a whole group at NIH working at MR Guided Interventions which we're interested in, and the bottom right is the CT-scan in a hybrid op
in a hybrid room, this is actually from MD Anderson. And I think this is actually the Trauma Room of the future, makes no sense to me to take a patient from an emergency room to a CT scanner to an and-jure suite to an operator it's the most dangerous thing we do
with a trauma patient and I think this is actually a position statement from the Trauma Society we're involved in, talk about how important it is to co-localize this imaging, and I think the trauma room of the future is going to be an and-jure suite
down with a CT scanner built into it, and you need to be flexible. Now, the Empire Strikes Back in terms of cloud-based fusion in that Siemans actually just released a portable C-arm that does cone-beam CT. C-arm's basically a rapidly improving,
and I think a lot of these things are going to be available to you at reduced cost. So let me move on and basically just show a couple of examples. What you learn are techniques, then what you do is look for applications to apply this, and so we've been doing
translumbar embolization using fusion and imaging guidance, and this is a case of one of my partners, he'd done an ascending repair, and the patient came back three weeks later and said he had sudden-onset chest pain and the CT-scan showed that there was a
sutured line dehiscence which is a little alarming. I tried to embolize that endovascular, could not get to that tiny little orifice, and so we decided to watch it, it got worse, and bigger, over the course of a week, so clearly we had to go ahead and basically and fix this,
and we opted to use this, using a new guidance system and going directly parasternal. You can do fusion of blood vessels or bones, you can do it off anything you can see on flu-roid, here we actually fused off the sternal wires and this allows you to see if there's
respiratory motion, you can measure in the workstation the depth really to the target was almost four and a half centimeters straight back from the second sternal wire and that allowed us really using this image guidance system when you set up what's called the bullseye view,
you look straight down the barrel of a needle, and then the laser turns on and the undersurface of the hybrid room shows you where to stick the needle. This is something that we'd refined from doing localization of lung nodules
and I'll show you that next. And so this is the system using the C-star, we use the breast, and the localization needle, and we can actually basically advance that straight into that cavity, and you can see once you get in it,
we confirmed it by injecting into it, you can see the pseudo-aneurism, you can see the immediate stain of hematoma and then we simply embolize that directly. This is probably safer than going endovascular because that little neck protects about
the embolization from actually taking place, and you can see what the complete snan-ja-gram actually looked like, we had a pig tail in the aura so we could co-linearly check what was going on and we used docto-gramming make sure we don't have embolization.
This patient now basically about three months follow-up and this is a nice way to completely dissolve by avoiding really doing this. Let me give you another example, this actually one came from our transplant surgeon he wanted to put in a vas,
he said this patient is really sick, so well, by definition they're usually pretty sick, they say we need to make a small incision and target this and so what we did was we scanned the vas, that's the hardware device you're looking at here. These have to be
oriented with the inlet nozzle looking directly into the orifice of the mitro wall, and so we scanned the heart with, what you see is what you get with these devices, they're not deformed, we take a cell phone and implant it in your chest,
still going to look like a cell phone. And so what we did, image fusion was then used with two completely different data sets, it mimicking the procedure, and we lined this up basically with a mitro valve, we then used that same imaging guidance system
I was showing you, made a little incision really doing onto the apex of the heart, and to the eur-aph for the return cannula, and this is basically what it looked like, and you can actually check the efficacy of this by scanning the patient post operatively
and see whether or not you executed on this basically the same way, and so this was all basically developed basing off Lung Nodule Localization Techniques with that we've kind of fairly extensively published, use with men can base one of our thoracic surgeons
so I'd encourage you to look at other opportunities by which you can help other specialties, 'cause I think this 3D imaging is going to transform what our capabilities actually are. Thank you very much indeed for your attention.
- [Ali] Thank you Dr. Jordan This is the results of the trial that led to the FDA approval of the Valiant Captivia Device for treatment of aortic dissection. This is a four-year update. I have no disclosures.
This is the epidemiology of aortic dissection. As you know, the outcomes of patients with acute complicated type aortic dissection leave a lot of room for improvement. With the open-repair operative mortality approaching 50-80% when there is mesenteric or renal ischemia.
The goal of TIVAR is to stabilize the aorta and promote remodeling. This includes covering the proximal entry tear. Treating or preventing rupture to expand the true lumen, caused false lumen regression and false lumen thrombosis and to alleviate distal malperfusion.
As you know, TIVAR is now considered first line therapy for patients with acute complicated type aortic dissection and this is the current European Society for Vascular Surgery guidelines. The objective of this study was to evaluate the performance of the Valiant Captivia device
for treatment of acute complicated type aortic dissection. 50 patients were enrolled at 16 US centers. This occurred between 2010 and 2012 and the patients are being followed up for five years. This the baseline demographics. As you can see, hypertension was prevalent.
Most patients were ASA Class IV or V. Vascular history and hypercholesteremia were also prevalent. The average age was 57 and 80% of the patients were male. This is the presentation symptoms. The majority of patients presented with back or chest pain
and a staggering 86% of the patients had malperfusion. 40% has visceral ischemia. 42% had renal ischemia. 40% lower extremity ischemia and 6% spinal cord ischemia. Antihypertensives were administered to 84% of the patients with ionotropic support required in 16%. This the procedural data.
There was a 100% delivery and deployment success. The proximal entry tear was covered in 100% of the subjects. And there was no misalignment noted. The over-sizing was 12 +/- 10% and the length of coverage approached 20 cm. This is the all-cause mortality.
The freedom from all-cause mortality at four years was 77%. As you can see, outside of the 30-day window there were no moralities directly attributed to aortic dissection. There was one pnuemonia on day 87
which according to the clinical adjudication committee was ruled as a dissection-related death but it wasn't a direct aortic-related death. This gives us a four-year freedom from dissection-related mortality which is 90% and for a complex group of patients
with acute complicated type aortic dissection this is remarkable. This graph also shows that there's been aortic stabilization with TIVAR and no late complications related to the aorta. There were no serious adverse events or secondary endovascular procedures in year 2, 3, or 4.
There were some procedures related to the dissection. Four patients had extension and one patient had embolic placement. And one patient had a subclavian plug. This is the aortic remodeling data. As you look at the four-year data
the maximum diameter of the false lumen decreased or remained stable in 87% of the patients. The maximum diameter of the true lumen increased in 100% of the patients. And there was partial or complete false lumen thrombosis in 96% of the patients.
In summary, there was 100% delivery and deployment success. There was aortic stabilization through the four-year period. There were no ruptures and at 4% retrograde type aortic dissection given this viable pathology. This is favorable aortic remodeling
with low need for secondary endovascular procedures. Thank you very much for your attention.
- Thank you, chairman. Good afternoon, ladies and gentlemen. I've not this conflict of interest on this topic. So, discussion about double-layer stent has been mainly focused about the incidence of new lesions, chemical lesions after the stenting, and because there are still some issue
about the plaque prolapse, this has still has been reduced in a comparison to conventional stent that's still present. We started our study two years ago to evaluate on two different set of population of a patient who underwent stent, stenting,
to see if there is any different between the result of two stents, Cguard from Inspire, and Roadsaver from Terumo in term of ischemic lesion and if there is a relationship between the activity of the plaque evaluated with the MRI
and new ischemic lesion after the procedure. So, the population was aware of similar what we found, and that there's no difference between the two stent we have had, and new ischemic lesions is, there's a 38%, for a total amount of 34 lesions,
and ipsilateral in 82% of cases. The most part of the lesion appeared at the 24 hours, for the 88.2% of cases, while only the 12% of cases, we have a control at our lesion. According to the DWI, we have seen that
the DWI of the plaque is positive, or there is an activity of the plaque. There's a higher risk of embolization with a high likelihood or a risk of 6.25%. But, in the end, what we learned in the beginning, what there have known,
there's no difference in the treatment of the carotid stenosis with this device, and the plaque activity, when positive at the DWI MR, is a predictive for a higher risk of new ischemic lesions at 24 hours. But, what we are still missing in terms of information,
where something about the patency of the stents at mid-term follow-up, and the destiny of external carotid artery at mid-term follow-up. Alright, we have to say we have an occlusion transitory, occlusion of the semi-carotid artery
immediately after the deployment of the Terumo stent. The ECA recovery completely. But in, what we want to check, what could happen, following the patient in the next year. So, we perform a duplicate ultrasound, at six, at 12, and 24 months after the procedure,
in order to re-evaluate the in-stent restenosis and then, if there was a new external carotid artery stenosis or occlusion. We have made this evaluation according to the criteria of grading of carotid in-stent restenosis proposed on Stroke by professors attache group.
And what we found that we are an incidence of in-stent restenosis of 10%, of five on 50 patient, one at six month and four at one year. And we are 4% of external carotid artery new stenosis. All in two patient, only in the Roadsaver group.
We are three in-stent restenosis for Roadsaver, two in-stent restenosis for Cguard, and external new stenosis only in the Roadsaver group. And this is a case of Roadsaver stent in-stent restenosis of 60% at one year. Two year follow-up,
so we compare what's happening for Cguard and Roadsaver. We see that no relation have been found with the plaque activity or the device. If we check our result, even if this is a small series, we both reported in the literature for the conventional stent,
we've seen that in our personal series, with the 10% of in-stent restenosis, that it's consistent with what's reported for conventional CAS. And the same we found when we compared our result with the result reported for CAS with conventional stent.
So in our personal series, we had not external carotid artery occlusion. We have 4% instance, and for stenosis while with conventional CAS, occlusion of external carotid artery appear in 3.8% of cases.
So, what can we add to our experience now in the incidence, if, I'm sorry, if confirmed by larger count of patient and longer study? We can say that the incidence of in-stent restenosis for this new double-layer stent and the stenosis on the external carotid artery,
if not the different for all, with what reported for conventional stent. Thank you.
- Thank you for asking me to speak. Thank you Dr Veith. I have no disclosures. I'm going to start with a quick case again of a 70 year old female presented with right lower extremity rest pain and non-healing wound at the right first toe
and left lower extremity claudication. She had non-palpable femoral and distal pulses, her ABIs were calcified but she had decreased wave forms. Prior anterior gram showed the following extensive aortoiliac occlusive disease due to the small size we went ahead and did a CT scan and confirmed.
She had a very small aorta measuring 14 millimeters in outer diameter and circumferential calcium of her aorta as well as proximal common iliac arteries. Due to this we treated her with a right common femoral artery cutdown and an antegrade approach to her SFA occlusion with a stent.
We then converted the sheath to a retrograde approach, place a percutaneous left common femoral artery access and then placed an Endologix AFX device with a 23 millimeter main body at the aortic bifurcation. We then ballooned both the aorta and iliac arteries and then placed bilateral balloon expandable
kissing iliac stents to stent the outflow. Here is our pre, intra, and post operative films. She did well. Her rest pain resolved, her first toe amputation healed, we followed her for about 10 months. She also has an AV access and had a left arterial steel
on a left upper extremity so last week I was able to undergo repeat arteriogram and this is at 10 months out. We can see that he stent remains open with good flow and no evidence of in stent stenosis. There's very little literature about using endografts for occlusive disease.
Van Haren looked at 10 patients with TASC-D lesions that were felt to be high risk for aorta bifem using the Endologix AFX device. And noted 100% technical success rate. Eight patients did require additional stent placements. There was 100% resolution of the symptoms
with improved ABIs bilaterally. At 40 months follow up there's a primary patency rate of 80% and secondary of 100% with one acute limb occlusion. Zander et all, using the Excluder prothesis, looked at 14 high risk patients for aorta bifem with TASC-C and D lesions of the aorta.
Similarly they noted 100% technical success. Nine patients required additional stenting, all patients had resolution of their symptoms and improvement of their ABIs. At 62 months follow up they noted a primary patency rate of 85% and secondary of 100
with two acute limb occlusions. The indications for this procedure in general are symptomatic patient with a TASC C or D lesion that's felt to either be a high operative risk for aorta bifem or have a significantly calcified aorta where clamping would be difficult as we saw in our patient.
These patients are usually being considered for axillary bifemoral bypass. Some technical tips. Access can be done percutaneously through a cutdown. I do recommend a cutdown if there's femoral disease so you can preform a femoral endarterectomy and
profundaplasty at the same time. Brachial access is also an alternative option. Due to the small size and disease vessels, graft placement may be difficult and may require predilation with either the endograft sheath dilator or high-pressure balloon.
In calcified vessels you may need to place covered stents in order to pass the graft to avoid rupture. Due to the poor radial force of endografts, the graft must be ballooned after placement with either an aortic occlusion balloon but usually high-pressure balloons are needed.
It usually also needs to be reinforced the outflow with either self-expanding or balloon expandable stents to prevent limb occlusion. Some precautions. If the vessels are calcified and tortuous again there may be difficult graft delivery.
In patients with occluded vessels standard techniques for crossing can be used, however will require pre-dilation before endograft positioning. If you have a sub intimal cannulation this does put the vessel at risk for rupture during
balloon dilation. Small aortic diameters may occlude limbs particularly using modular devices. And most importantly, the outflow must be optimized using stents distally if needed in the iliac arteries, but even more importantly, assuring that you've
treated the femoral artery and outflow to the profunda. Despite these good results, endograft use for occlusive disease is off label use and therefor not reimbursed. In comparison to open stents, endograft use is expensive and may not be cost effective. There's no current studies looking
into the cost/benefit ratio. Thank you.
- Yeah now, I'm talking about another kind of vessel preparation device, which is dedicated to prevent the occurrence of embolic events and with these complications. That's a very typical appearance of an occluded stent with appositional stent thrombosis up to the femur bifurcation.
If you treat such a lesion simply with balloon angioplasty, you will frequently see some embolic debris going downstream, residing in this total occlusion of the distal pocket heel artery as a result of an embolus, which is fixed at the bifurcation of
the anterior tibial and the tibial planar trunk, what you can see over here. So rates of macro embolization have been described as high as 38% after femoral popliteal angioplasty. It can be associated with limb loss.
There is a risk of limb loss may be higher in patients suffering from poor run-off and critical limb ischemia. There is a higher rate of embolization for in-stent restenosis, in particular, in occluded stents and chronic total occlusions.
There is a higher rate of cause and longer lesions. This is the Vanguard IEP system. It's an integrated balloon angioplasty and embolic protection device. You can see over here, the handle. There is a rotational knob, where you can,
a top knob where you can deploy, and recapture the filter. This is the balloon, which is coming into diameters and three different lengths. This is the filter, 60 millimeter in length. The pore size is 150 micron,
which is sufficient enough to capture relevant debris going downstream. The device is running over an 80,000 or 14,000 guide-wire. This is a short animation about how the device does work. It's basically like a traditional balloon.
So first of all, we have to cross the lesion with a guide-wire. After that, the device can be inserted. It's not necessary to pre-dilate the lesion due to the lower profile of the capture balloon. So first of all, the capture filter,
the filter is exposed to the vessel wall. Then you perform your pre-dilatation or your dilatation. You have to wait a couple of second until the full deflation of the balloon, and then you recapture the filter, and remove the embolic debris.
So when to use it? Well, at higher risk for embolization, I already mentioned, which kind of lesions are at risk and at higher risk of clinical consequences that should come if embolization will occur. Here visible thrombus, acute limb ischemia,
chronic total occlusion, ulceration and calcification, large plaque volume and in-stent reocclusion of course. The ENTRAP Study was just recently finished. Regarding enrollment, more than 100 patients had been enrolled. I will share with you now the results
of an interim analysis of the first 50 patients. It's a prospective multi-center, non-randomized single-arm study with 30-day safety, and acute performance follow-up. The objective was to provide post-market data in the European Union to provide support for FDA clearance.
This is the balloon as you have seen already. It's coming in five and six millimeter diameter, and in lengths of 80, 120 and 200 millimeters. This is now the primary safety end point at 30 days. 53 subjects had been enrolled. There was no event.
So the safety composite end point was reached in 100%. The device success was also 100%. So all those lesions that had been intended to be treated could be approached with the device. The device could be removed successfully. This is a case example with short lesion
of the distal SFA. This is the device in place. That's the result after intervention. That's the debris which was captured inside the filter. Some more case examples of more massive debris captured in the tip of the filter,
in particular, in longer distance total occlusions. Even if this is not a total occlusion, you may see later on that in this diffused long distance SFA lesion, significant debris was captured. Considering the size of this embolus,
if this would have been a patient under CLI conditions with a single runoff vessel, this would have potentially harmed the patient. Thank you very much.
- Okay, so I first continue. So after this data, which really, in our experience, really changed our treatment, we really don't want to treat, actually thoracoabdominals without coiling anymore. Now how to do it and, in fact, we also went through quite a learning curve. In the beginning, of course, was not easy for us
to reach segment arteries and big aneurysms all the tine. We learned form coiling in infrarenal aneurysms, I think, quite a lot and extended then to a higher segment of the aorta. So all together, it was not a short learning curve. So first of all, again, how do we do it?
We do it in local anesthesia, percutaneous, actually, always trans-femoral, although, sometimes the segmented arteries have a steep, at least in the beginning, a steep course downwards. We actually never come from brachial. We don't do a spinal drainage during coiling
and we monitor the patients 48 hours after that. We keep them in the hospital to see whether they develop any neurological complications, which they have, so far, never done. We don't do it on an intensive care and we also do not do spinal drainage then
during the stent graft implantation, which eventually, later then is done in general anesthesia. So this is the basic of the treatment, this is a little bit adopted from neuro radiology. Though, we are just taking bigger devices, so standard is so to say takes some six French
guiding catheter, usually I take an ema curve like this here. And into that very nicely fits a catheter, which is usually a source catheter, not this one, the source catheter is straight here. And through that source catheter, which is five French
catheter, we take a micro catheter through and that is here, this so called tower of power, which has been described, as I said, for neuro radiology procedures. So this is, however, sometimes the problem, you can of course choose several different curves here,
some are smaller, some are bigger. Bigger may not be so easy to handle and direct to your origin of the segmental artery, but in big aneurysms, of course, that can be a problem here to reach the arteries. So what we do with sticking a diagnostic catheter
into the guiding catheter is, that if you pull back here, now, your five French diagnostic catheter, you can really make out of this, move the twistable, toggleable catheter and that enables you in many cases to eventually then, really, in a stable way reach the ostium.
In those cases, where this is not possible, we use this steering deflecting steerable guiding catheters or sheaths, which is, of course, expensive and is really only necessary in very few selective cases, but this is clearly also helpful here. Side wind to one is loaded and then you can reach,
also, in very big arteries, aortas, the segmental ostium quite conveniently. So, of course, we don't do it in all cases, not in urgent repair, because after coiling or after every session of coiling, we want to have some time to let the spinal network develop.
So we can't do it in urgent cases. Renal insufficiency is a problem, although, with CT reading sometimes it's not so difficult to find the segmental artery origins, also, with very little contrast. Severe iliac kinking, aortic elongation
can be a problem indeed, we have some tricks for this and adipositas permagna, well, can be difficult, of course, difficult to see sometimes these arteries and that also requires then quite high radiation doses. This is what we do in very kinked iliac arteries and this is extremely helpful to have this some kind
of reinforced or extended power of tower. So in the beginning, we took a 12 French sheath in, we let the stiff wite in and we punctured, once again, up here of the sheath and brought parallel up then our usually power of tower and with this, you have a very, very stable condition
to reach the segmental arteries. Reason, that we changed to 12 French to nine French sheath, I don't think this is a problem in our days, having closure devices available for these kind of cases. So what shall we take for coiling, usually, we take this, let's call it regular coils
with these feathers, like, things here on top to induce thrombosis. Sometimes, in bigger segmental arteries, you can also do use a vascular plugs. This requires relatively stable access to the arteries. Clearly, no fluids, which are risky
and can embolize distally, we fear and may induce here even a spinal ischemia. So we have never used any fluids in these kind of cases. We are also still in the learning curve, for example, sometimes the arteries after coiling to open up again. Here is a case several weeks after coiling,
you can see here, that the blood here just passes these coils here, this is another case, where you can see, that actually the blood flow seems to be not diminished due to this coiling. So segmental arteries, we learned, are really completely different to others, you never see atherosclerosis here,
sometimes in the origin, probably some plug from the aorta, but they can develop very quickly to bigger arteries and that's why we probably see sometimes here a flow going down. So again, also, we have still a lot of things to work. Is it necessary to occlude them completely?
Is maybe reduction of flow sufficient? Sometimes maybe spinal ischemia is also due to embolization through segmental arteries and then this should actually be sufficient to avoid any embolization into the spinal cord. So after embolization, well, during embolization, also,
we also have to ask ourselves how densely do we have to pack these, cuz you can see, that there is several open areas between the coils. That should be actually usually enough to induce thrombosis. This is, we think, clearly, not enough and this is from the first publication,
not from our institute, I think this is definitely not enough, so indeed, you have to have some stable position of your catheter to pack these coils in and try to occlude the arteries as good as you can. So again, some questions to the coils, which should be used, the standard coils, maybe, which still have always
some holes in between. There are others, for example, the volume coils, which are used in neuro radiology. Which with one coil you can complete occlude the artery. Or there are some micro plugs, which actually go through micro catheters, those here are really
more sufficient and effective in closing the artery, but clearly they are also much more expensive, than regular coils. Where to coil, I think, it's very important not to coil too far distal, because then you're counter productive, you maybe avoid production or development
of this spinal network, you should really try to coil here at that proximal part here to let those networks here distally develop. This is, I think, very important and nevertheless, it can also occur, that you're actually coiling here at that proximal part or some collaterals develop
also proximal to these coils. So the more ostium your coil, I think, are better here. You can see, that we coiled here, but some coils collaterals developed here, feeding, now, here another segmental artery, which is secluded and the proximal part, but at the end we were not completely successful here
in occluding this segmental artery. So shall we also close every artery, shall we only close small arteries, sometimes we see, especially, in big aneurysms, that your ostium here is twisted and become stenotic, will become very difficult to get in. Same artery six weeks later, you can see here,
that it has developed already some collaterals, so do we need to coil this also? These are also still open questions. And then some thoughts about where to start. In the past, it was thought, that it was one big Adamkiewicz artery, great marginal artery,
but that is currently obsolete. We know, that there are several here. So shall we look for the biggest anterior radiculomedullary artery and shall we start with coiling here or shall we start somewhere else? Usually this ARMA, this big ARMA comes off
between TH 11, L one, L two, usually on the left side, here on the right side, so we found here, with our first shot here, this big ARMA going here into this spinal artery. So should we not close this now or should we exactly close this first, these are still open questions. First we go to this here, to have this closed
and let others develop here, some collaterals here. Here is another case, where a stent graft was already in this, not a covered stent, but an open cell stent and here we saw, that here are already some collaterals opened up. You can see here due to an injection to the right side,
this collateral worked upwards and then to the left side, finally here feeding the anterior spinal artery. So also in these cases, it demonstrates to you, that you should coil here, maybe, first, before you go to the other arteries. This is another example here, where to start,
how many and the first session, usually, we do four arteries. In the beginning, this is just our protocol, where we start now. We start usually in that area, we think the main radiculomedullary artery has its offspring
and from that we go more distal and into the proximal counterpart. So to summarize segmental artery coiling and these thoracoabdominal aneurysms can be challenging, it's a new field with may open questions. About our first experience with this is, for us,
really very promising and it's also safe. Thank you very much. (applauding) - [Man] Thank you for this great presentation. I have few questions to you, how long do you need for such an intervention?
And how can you be sure before you start with implantation, I suppose, that you will do this not in one session, but you will do this with a timeframe. That was a long year waiting and before you start to implant the prothesis, it is the question for you too, how you control, that all artery occlude?
- [Presenter] Yeah, many questions, so first of all, how long does it take to coil. So of course, in the beginning it took us some time. It always-- - [Man] Some hours. - [Presenter] Not some hours,
but you have published this also in your publication. - So the data, that we started with like two hours, maybe, it was two hours, but now we got under one hour. - [Presenter] Under one hour per session, let's say for segmental arteries.
It always depends, also, on the anatomy. In the beginning, we were waiting quite a lot between these coilings, because of course, that was all new for us, so we took the time, usually, these are cases, where you ordered a CMD, so you had a timeframe of two months or longer
to wait for the graft anyway. So this time we took for segmental artery coiling, we took several weeks in between segmental artery coiling, bu knowing from the animal models, that during one week, that spinal network should develop, actually, now, down to one week in between coiling sessions.
- [Man] Okay and how you control before you implant? - [Presenter] We don't. - [Man] You don't, you're hoping only? - [Presenter] Well, we have seen some segmental arteries open again, so we did, clearly, did not investigate this systematically, how many did open.
Again, because there are many questions. Maybe it's really enough to just have some coils and to prevent any embolization during the stent graft implantation towards spinal ischemia. We don't know all this, it seems to be a little bit problematic to really check it, we could check it by CT,
you could check it by angiography, but since you're using a lot of contrast during the stent graft implantation anyway there was a step, which we actually did not, now, do systematically. - [Man] And how many coils do you need to close all these arteries?
- [Presenter] For one segmental artery, you need something like four, five, six coils. So this, usually, coils, they recently got very cheap. - [Man] A very cheap intervention. - [Presenter] It is, it is, in fact, not too expensive. If you would use these volume coils, plugs,
that would be a completely other story on micro plugs, but these very standard coils is not expensive, indeed. - [Man] The last question, it is in regard of the application of this technique. Did you have any spinal lesions after stent implantation? - [Woman] So in this series, we have not had any issues
and we are currently looking at the matter, the non invasive imaging to exactly establish when is the point, the best point to implant the stent graft do we really need to wait as long or if we can implant it sooner. So we have some clues, that the preconditioning,
it's developing in one week and we are ready to go for the stent graft. It's very important, that you perioperatively, you adopt the classical perioperative on your strategies. That means we stop the blood pressure, lowering medication so we have a minatorial pressure of 85 to 90 millimeter
of mercury, we have a good oxygen saturation, that means you have a hemoglobin level around 10 gram per deciliter. And also on the ISU, the patient have the same tract. And we basically, we looked, that during the first month, the blood pressure of the patient, it's not too low.
- [Man] Do you have the impression this relationship between the type of aneurysm or the length of aneurysm, they're anatomical and the need of such an intervention? - [Woman] Well, basically, you've seen the data, the published data shows, that the inner thoracoabdominal krau-for type two after, endovascular period
you have up to 19% spinal cord ex-pand-ment of open repair, it's 22%. My opinions is, that the mechanism of spinal cord ischemia after about this procedure, it's different, but basically you need to treat both type of patient for the endovascular pair with both.
We think, that we should treat type two for sure and type three also and maybe type four, and we think type four too, because the proximal landing zone in those type of repair, it's not, it's not the same. So type four, basically, you treat it endo, you get your landing zone, as for treating type three,
and type three, it's getting in type two. - [Man] And did you observe any neurological side effect during the embolization? - [Woman] Recently, we had a patient, where we inject contrast and she had some numbness in her legs, but after two minutes or less than one minute,
she had nothing and we continue with the procedure and she recovered. But her blood pressure were, as I remember, it was not high, it was at systolic of 120 millimeter, that's why we stopped that coiling for that patient. And we had her blood pressure medication stopped
and recoiled them, her, after, I think, seven days. And we had no clinical evidence of spinal cord ischemia. - [Man] Thank you again for all this information, so that we implanted stents for years without this technique.
- [Presenter] Sorry? - [Man] Was that a criminal act? - [Presenter] No, I can only, from our experience, we did have quite some spinal cord ischemias after extensive stent grafting in long thoracoabdominal aneurysms.
It's always very terrible experience to have this. Since we do coiling, we didn't have any problem anymore. It's not a lot of patients, which I think, all together, we have maybe 80 now, but due to this experience, I don't want to do stent grafting without coiling anymore. - [Man] Okay, this is a very important message,
because this is a real religious message.
- I'd like to thank Dr. Veith for this kind invitation and the committee as well. So these are my disclosures, there's none. So for a quick background regarding closure devices. Vascular closure devices have been around
for almost 20 years, various types. Manual compression in most studies have always been shown to be superior to vascular closure devices mainly because there's been no ideal device that's been innovated to be able
to handle all sorts of anatomies, which include calcified vessels, soft plaque, etc. So in this particular talk we wanted to look at to two particular devices. One is the Vascade vascular closure device
made by Cardiva and the other is the CELT arterial closure device made by Vasorum in Ireland. Both these devices are somewhat similar in that they both use a disc. The Vascade has a nitinol disc
as you can see here that's used out here to adhere to the interior common femoral artery wall. And then once tension is applied, a series of steps is involved to deploy the collagen plug
directly on to the artery which then allows it to expand over a period of time. The CELT is similar in that it also uses a stainless steel disc as you can see here. Requires tension up against the interior wall of the common femoral artery.
Nice and tight and then you screw on the top end of the device on to the interior wall of the artery creating a nice little cylinder that compresses both walls of artery. As far as comparability is concerned between the two devices you can see
here that they're both extravascular, one's nitinol, one's stainless steel. One uses a collagen material, the other uses an external clip in a spindle-type fashion. Both require about, anywhere between three to seven minutes of pressure
to essentially stop the tract ooze. But the key differences between the two devices, is the amount of time it takes for patients to ambulate. So the ambulation time is two hours roughly for Vascade, whereas for a CELT device
it's anywhere from being immediate off the table at the cath lab room to about 20 minutes. The data for Vascade was essentially showing the RESPECT trial which I'll summarize here, With 420 patients that was a randomized trial
to other manual compression or the device itself. The mean points of this is that the hemostasis time was about three minutes versus 21 minutes for manual compression. And time to ambulation was about 3.2 hours versus 5.7 hours.
No major complications were encountered. There were 1.1% of minor complications in the Vascade versus 7% in the manual compression arm. This was actually the first trial that showed that a actual closure devices
had better results than manual compression. The main limitations in the trial didn't involved complex femoral anatomy and renal insufficiency patients which were excluded. The CELT ACD trial involved 207 patients that were randomized to CELT or to manual
compression at five centers. Time to hemostasis was anywhere between zero minutes on average versus eight minutes in the manual compression arm. There was one complication assessed at 30 days and that was a distal embolization that occurred
early on after the deployment with a successfully retrieved percutaneously with a snare. So complication rate in this particular trial was 0.7% versus 0% for manual compression. So what are some pros and cons with the Vascade device?
Well you can see the list of pros there. The thing to keep in mind is that it is extravascular, it is absorbable, it's safe, low pain tolerance with this and the restick is definitely possible. As far as the cons are involved.
The conventional bedrest time is anywhere between two to three hours. It is a passive closure device and it can create some scarring when surgical exploration is necessary on surgical dissections.
The key thing also is you can not visualize the plug after deployment. The pros and cons of the CELT ACD device. You can see is the key is the instant definitive closure that's achieved with this particular device, especially in
calcified arteries as well. Very easy to visualize under fluoroscopy and ultrasound. It can be used in both antegrade and retrograde approaches. The key cons are that it's a permanent implant.
So it's like a star closed devised, little piece of stainless steel that sits behind. There's a small learning curve with the device. And of course there's a little bit of discomfort associated with the cinching under the (mumbles) tissue.
So we looked at our own experience with both devices at the Christie Clinic. We looked at Vascade with approximately 300 consecutive patients and we assessed their time to hemostasis, their time to ambulation,
and their time to discharge, as well as the device success and minor and major complications. And the key things to go over here is that the time to hemostasis was about 4.7 minutes for Vascade, at 2.1 hours for ambulation, and roughly an average
of 2.4 hours for discharge. The device success was 99.3% with a minor complication rate of .02% which we have four hematomas and two device failures requiring manual compression. The CELT ACD device we also similarly did
a non-randomized perspective single center trial assessing the same factors and assessing the patients at seven days. We had 400 consecutive patients enrolled. And you can see we did 232 retrograde. We did a little bit something different
with this one, we did we 168 antegrade but we also did direct punctures to the SFA both at the proximal and the mid-segments of the SFA. And the time to hemostasis in this particular situation was 3.8 minutes,
ambulation was 18.3 minutes, and discharge was at 38.4 minutes. We did have two minor complications. One of which was a mal-deployment of the device requiring manual compression. And the second one was a major complication
which was an embolization of the device immediately after deployment which was done successfully snared through an eighth front sheath. So in conclusion both devices are safe and effective and used for both
antegrade and retrograde access. They're definitely comparable when it comes, from the standpoint of both devices (mumbles) manual compression and they're definitely really cost effective in that they definitely do increase the
throughput in the cath lab allowing us to be able to move patients through our cath lab in a relatively quick fashion. Thank you for your attention.
- Thank you very much again. Thank you very much for the kind invitation. The answer to the question is, yes or no. Well, basically when we're talking about pelvic reflux, we're talking really, about, possibly thinking about two separate entities. One symptoms relate to the pelvis
and issues with lower limb varicose veins. Really some time ago, we highlighted in a review, various symptoms that may be associated with the pelvic congestion syndrome. This is often, either misdiagnosed or undiagnosed. The patients we see have had multiple investigations
prior to treatment. I'm not really going to dwell on the anatomy but, just really highlight to you it is incompetence in either the renal pelvic and ovarian veins. What about the patterns of reflux we've heard from both Mark and Nicos what the pattern are
but, basically if you look a little more closely you can see that not only the left ovarian vein is probably effected in a round-about 60%. But, there is incompetence in many of the other veins. What does this actually have implication for with respect to treatment.
Implications are that you probably, if you only treat an isolated vein. There is a suggestion, that the long term outcomes are not actually as good. Now this is some work from Mark Whiteley's group because, we've heard about the diagnosis
but, there is some discussion as to whether just looking at ovarian vein diameter is efficient and certainly the Whiteley group suggests that actually diameter is relatively irrelevant in deciding as to whether there is incompetence in the actual vein itself.
That diameter should not be used as a single indicator. You may all well be aware, that there are reporting standards for the treatment of pelvic venous insufficiency and this has been high-lighted in this paper. What of the resuts, of pelvic embolization and coiling? The main standard is used, is a visual analog scale
when you're looking at pelvic symptoms to decide what the outcome may be. This is a very nice example of an article that was... A review that was done in Niel Khilnani's group and you can see if you look at the pre
and post procedural visual analog scales there is some significant improvement. You can see that this is out at one year in the whole. Now, this is a further table from the paper. Showing you their either, there's a mixture
of glue, coils, scleroses and foam. The comments are that, there are significant relief and some papers suggest its after 100% and others up to 80%. If you look at this very nice review that Mark Meissner did with Kathy Gibson,
you will see that actually no improvement in worse. There's quite a range there for those patients 53% of patients in one study, had no improvement or the symptoms were potentially worse. We know that those patients who have coil embolization will have reoccurrence of symptomatology
and incompetence up to about a quarter of the patients. What about varicose veins? The answer is there is undoubtedly evidence to suggest that there is physiological/anatomical incompetence in some of the pelvic veins in patients
who have recurrent varicose veins. Whether this is actually a direct cause or an association, I think it's something we need to have some further consideration of. As you know, there are many people who now would advicate actually treating
the pelvic veins prior to treating the leg veins. You can maybe discuss that in the question time. If we then look at a comparative trial. Comparing coils and plugs, you can see over all there really isn't no particular difference. If we then look again to highlight this,
which comes again from the Whiteley group. You can see that 20% of patients will have some primary incompetence but, it'll go up to around 30% if they are re-current. There is no randomized control data looking at this. What are the problems with coils?
Actually, a bit like (mumbling) you can find them anywhere. You can find them in the chest and also you can find that there are patients now who are allergic to nickel and the very bottom corner is a patient who's coils I took out by open laparotomy because they were allergic to nickel.
So, ladies and gentlemen I would suggest to you certainly, for continuing with pelvic embolization when doubtedly it needs some more RCT data and some much better registry data to look where we're going. Thank you very much.
- Thank you, good morning everybody. Thank you for the kind invitation, Professor Veith, it's an honor for me to be here again this year in New York. I will concentrate my talk about the technical issues and the experience in the data we have already published about the MISACE in more than 50 patients.
So I have no disclosure regarded to this topic. As you already heard, the MISACE means the occlusion of the main stem of several segmental arteries to preserve the capability of the collateral network to build new arteries. And as a result, we developed
the ischemic preconditioning of the spinal cord. Why is this so useful? Because it's an entirely endovascular first stage of a staged approach to treat thoracoabdominal aortic aneurysm in order to reduce the ischemic spinal cord injury.
How do you perform the MISACE? Basically, we perform the procedure in local anesthesia, through a percutaneous trans-femoral access using a small-bore sheath. The patient is awake, that means has no cerebrospinal fluid damage
so we can monitor the patient's neurological for at least 48 hours after the procedure. So, after the puncture of the common femoral artery, using a technique of "tower of power" in order to cannulate the segmental arteries. As you can see here, we started with a guiding catheter,
then we place a diagnosis catheter and inside, a microcatheter that is placed inside the segmental artery. Then we started occlusion of the ostial segment of the segmental artery. We use coils or vascular plugs.
We don't recommend the use of fluids due to the possible distal embolization and the consequences. Since we have started this procedure, we have gained a lot of experience and we have started to ask,
what is a sufficient coilembolization? As you can see here, this artery, we can see densely packed coils inside, but you can see still blood flowing after the coil. So, was it always occluding, or is it spontaneous revascularization?
That, we do not know yet. The question, is it flow reduction enough to have a ischemic precondition of the spinal cord? Another example here, you can see a densely packed coil in the segmental artery at the thoracic level. There are some other published data
with some coils in the segm the question is, which technique should we use, the first one, the second one? Another question, is which kind of coil to use? For the moment, we can only use the standard coils
in our center, but I think if we have 3-D or volume coils or if you have microvascular plugs that are very compatible with the microcatheter, we have a superior packing density, we can achieve a better occlusion of the segmental artery, and we have less procedure time and radiation time,
but we have to think of the cost. We recommend to start embolization of the segmental artery, of course, at the origin of it, and not too far inside. Here, you can see a patient where we have coiled a segmental artery very shortly after the ostium,
but you can see here also the development of the collaterals just shortly before the coils, leading to the perfusion of segmental artery that was above it. As you can see, we still have a lot of open question. Is it every patent segmental artery
a necessary to coil? Should we coil only the large ones? I show you an example here, you can see this segmental artery with a high-grade stenotic twisted ostium due to aortic enlargement.
I can show you this segmental artery, six weeks after coiling of a segmental artery lower, and you can see that the ostium, it's no more stenotic and you can see also the connection between the segmental artery below to the initial segmental artery.
Another question that we have, at which level should we start the MISACE? Here, can see a patient with a post-dissection aneurysm after pedicle technique, so these are all uncovered dissection stent, and you can see very nicely the anterior spinal artery
feeded by the anterior radiculomedullary artery from the segmental artery. So, in this patient, in fact, we start the coiling exactly at the seat of this level, we start to coil the segmental artery that feeds the anterior spinal artery.
So, normally we find this artery of the Th 9 L1, and you can see here we go upwards and downwards. We have some challenges with aneurysm sac enlargement, in this case, we use this technique to open the angle of the catheter, we can use also deflectable steerable sheath
in order to reach the segmental artery. And you can see here our results, again, I just will go fast through those, we have treated 57 patients, most of them were Type II, Type III aortic aneurysms. We have found in median nine patent segmental artery
at the level of the aorta to be treated, between 2 and 26, and we have coiled in multiple sessions with a mean interval of 60 days between the sessions. No sooner than seven days we perform the complete exclusion of the aneurysm
in order to let the collateral to develop, and you can see our result: at 30 days we had no spinal cord ischemia. So I can conclude that our first experience suggest that MISACE is feasible, safe, and effective, but segmental artery coiling in thoracoabdominal aneurysm
can be challenging, it's a new field with many open questions, and I looking forward for the results with PAPA_ARTiS study. Thank you a lot.
- Thank you Tim, Manny, Dr. Veith. Again thank you for the kind invitation. Um, here are my disclosures. The Chimney Snorkel Sandwich technique is really one that's been used and discussed many times throughout this great meeting in years past.
I've been asked to kind of see how we expand the use for thoracoabdominal aneurysms. Um, basically it's a matter of putting a parallel graft and then having an inner graft that will help seal the aneurysm sac itself by maintaining
perfusion to the visceral vessels. Um, the number of parallel grafts has been shown to be of note, and generally if you get beyond two parallel grafts at any one location, that tends to dramatically increase the incidence of
gutter leaks and potential for continued perfusion of the aneurysm sac. Here again showing at two, they still keep a reasonable aortic diameter, but once you start going three and four parallel grafts you tend to have significant compression
of the main aortic graft itself, as well as the potential for gutter leaks. Um, the PERICLES Registry certainly looked as I know has been discussed earlier in this meeting, and basically what it showed was that this was a reasonable way of treating
some of these complex aneurysms with a durable outcome going out to two to three years, uh, at a survival rate of over 70 percent. So, to show how we use this for patients with thoracoabdominal aneurysms, this was a 67 year, I use the term is,
a 67-year-old gentleman presented urgently with a sudden onset of back and abdominal pain. Apparently he was, uh, had a new wife and was trying some sexually enhancing medications from the DR. Had a history of coronary artery disease,
erectile dysfunction, and congestive heart failure, and CT scan revealed a type four thoracoabdominal dissection with a eight centimeter juxtarenal aneurysm, and he was in acute pain. Uh, here is the CT scan as we go through,
and you can see obviously the very complex dissection. You had a small segment of perfusion still around the level of the celiac going down into the SMA, uh, and then this rather, again the renals were
also with a small luminal area, and then a large aneurysm going up to eight centimeters going down into the abdominal component, and then reasonable access vessels from below. This shows the dissection extending down
through the thoracoabdominal segment, and again, he was in acute pain. Uh, so we came in and did an angiogram and IVUS, uh, and here we show the area of the dissection going down as well as the take-off of the subclavian artery.
Again, the true lumen being here. This was confirmed with IVUS. The IVUS sash, and this is the true lumen here, the false lumen being around the periphery, and as you go through you can see there's almost complete collapse of that
true lumen throughout the cardiac cycle. Uh, we performed a left carotid subclavian bypass, and embolized the left subclavian artery and put a thoracic endograft in, covering that lead point as you go in and taking it really almost up to the level of the left carotid artery.
There you can see the occluded subclavian. Uh, with that in place we then prepared to do a four vessel sandwich, or double sandwich, technique. Here we came down, we brought the grafts down to about the level of the takeoff of the celiac access with thoracic endografts.
Lateral shows the takeoff of the celiac and the SMA. Uh, we were able to catheterize both those vessels from the axillary region and put stents going out in this two sandwich technique, uh, and then actually put our stents going out from both the celiac and SMA.
We then were able to do that once we had those stents in place with adequate overlap and no real gutter leak, we then came down and similarly put another graft down to the takeoff of the renal vessels and then selectively catheterized
the right and left renal. Here you can see the stenosis near the origin of the right renal artery. With that we then performed balloon angioplasty with covered stents, I believe these were VBX stents going out,
and then covered that further down as we went down into the area of the eight centimeter aneurysm. And here we come in building down from that area and the perivisceral segment down and then to the iliacs showing good perfusion down to the takeoff of the
hypogastric, and then finally angiogram showed we had good perfusion to celiac, SMA, both renal vessels, and then down through the aneurysm sac itself. This is, uh, he remains stable. His postoperative course actually was uneventful.
He was discharged from the hospital at day four. He's been seen back now at one year follow up at six and 12 month follow up and he's remained stable with no evidence of endo-leak. So I appreciate the opportunity to try and present a more novel way of managing
these patients in the acute setting. Thank you very much.
- That's a long title, thank you. We shortened the title, and just said, The Iliac Artery's Complicating Complex Juxtarenal and Thoracal Abdominal Repair. I have no disclosures. So, Iliac artery preservation is important whenever we start doing complex aortic aneurysm repair.
We don't understand completely what the incidence is with these extensive aneurysms. We know with AAAs, anywhere in the 10 to 40% have some sort of iliac artery involvement. It certainly can complicate the management as we get to these more complicated repairs.
Iliac artery preservation may be important for prevention of spinal cord ischemia, and those people in whom we can maintain both hypogastric arteries, it occurs at a less significant rate, with less severe symptoms and higher rates of recovery.
The aim of our study was to evaluate the incidence, management, and outcomes of iliac artery aneurysms associated with complex aortic aneurysms treated with fenestrated and branched endografts. Part of a PS-IDE study over a 15 year period of time,
this is dated from the Cleveland Clinic for the treatment of juxtarenal aneurysms and thoracal abdominal aortic aneurysms. For the purpose of this study, we defined an iliac artery aneurysm is 21 mm or greater as determined by diameter
by our core lab. We chose 21 mm because this was outside of the IFU for the iliac wounds that we had currently available to us at that time. We did multivariable analysis on the number of different outcomes. And we looked at the incidence
of iliac artery aneurysms by repair type. In all the aneurysms we treated, we see about a third of the patients had some level of iliac artery aneurysm involvement. In those patients that had less extensive thoracal abdominals, the type three
and type four abdominals, it occurred in about a third of the cases. A little bit less than the type two and the type one thoracal abdominals. We look at the demographics between those that had iliac artery aneurysm
involvement and those that did not have iliac artery involvement. It was more common in males to have iliac artery involvement than any other group. There are more females that didn't have iliac artery aneurysms. The rest
of the demographics were the same between the two groups. We look at the anatomic characteristics of the iliac artery aneurysms, about 60% of them were unilateral, about 40% of them were bilateral.
The mean iliac artery aneurysm size was 28 mm and that was the same on both sides. And we look at thought the percent that were actually very large, or considered large enough to potentially in and of themselves the repairs
greater than three centimeters. About 28% of them were greater than three centimeters on each side. If we look at our iliac artery aneurysm treatment type, this is 509 iliac artery aneurysms that
were treated out of all these patients. About 46% of them, we were able to obtain a seal distal to the iliac artery aneurysm. So it really only involved the proximal portion, the proximal half of the iliac artery.
20% of them, we placed a hypogastric branched endograft, and about 20% of them, we placed a hypogastric coverage plus embolization of that internal iliac artery. About 13% of them were left untreated at the time for a variety of different operative reasons.
Why is there a difference between the hypogastric coverage and embolization? It was availability of devices and surgeon choice at the time. At one point, we had a opportunity to be able to treat both fairly easily
on both sides and at one point we did not. Larger iliac artery aneurysms were treated with hypogastric coverage or hypogastric branched endografts, and there was a significant difference between the two. Most of the mean
size of those that were actually treated with either hypogastric branch or embolization for greater than three centimeters. If we look at peri-operative outcomes in those without iliac artery aneurysms versus those with iliac artery aneurysms.
We see that the fluoroscopy estimated blood loss is larger for those with iliac artery aneurysms, fluoroscopy time was longer and procedure duration was a bit longer as well. Obviously, a bit more complicated procedure,
more steps that's going to take a little bit longer to perform them. It did not effect the length of stay for these patients or the length of stay in the intensive care unit following the procedures. We look
at all-cause mortality at five years, no difference in whether they had an iliac artery aneurysm or not. It didn't matter whether it was unilateral or bilateral. If we look at aneurysm-related mortality, it's the same whether
they had the iliac artery aneurysm or not. Same for unilateral versus bilateral as well. Where we start to see some differences are the freedom from reintervention. This did vary between, among the three groups. In those patients without an iliac
artery aneurysm, they had the lower reintervention rate than those with the unilateral iliac artery aneurysm, and even lower rates from freedom from reintervention in those that had bilateral iliac artery aneurysms. Spinal cord ischemia, one of the
reasons we try to preserve both the hypogastric arteries. Look at our total spinal cord ischemia incidents. It didn't vary between the two groups, but if we look specifically, the type two thoracal abdominal aortic aneurysms in those patients that had bilateral
iliac arte higher rate of spinal cord ischemia compared to those that did not have any iliac artery aneurysms or those that had an internal iliac, a single iliac artery aneurysm.
So, iliac artery aneurysms affect about a third of the patients with complex aortic disease. They do not, their presence does not affect all-cause mortality or aneurysm related mortality. They are associated with a higher reintervention rate.
In extensive aneurysms, may be higher association with higher spinal cord ischemia rates. We need additional efforts are needed to improve outcomes and understanding appropriate application of different treatment options for patients with
complex aortic disease. Thank you.
- Well, thank you Andrej, I will present you the minimal invasive segmental artery coil embolization for prevention of spinal cord ischemia during EVAR of thoracoabdominal aortic pathologies, our initial clinical results. As all, I have nothing to disclose related to this presented topic.
As all we know ischemic spinal cord injury has a high incidence up to 20% after open or endovascular repair of thoracoabdominal aortic aneurysm and this is despite conventional perioperative neuroprotective strategies such as blood pressure management or continuous CSF drainage and also despite staged aortic repair such as
staged endovascular repair or temporary aneurysm sac perfusion. That's why our opinion is that, we have to have a pragmatic approach for prevention of spinal cord ischemia. First, our opinion is that you've to revascularize as many inflow arteries as possible such as
subclavian or hypogastric artery. You've to optimize your hemodynamic management perioperatively and last but not the least, we think that you've to improve your strategies that induce development of collateral arteries, that means, you have to ischemic precondition the spinal cord.
The ischemic preconditioning of the spinal cord is based on the collateral network concept of the spinal cord perfusion and that means that the hypothesis of spinal blood supply depending mainly on the critical arterial input of the Adamkiewicz artery is obsolete. As you can see here, of some of our intraoperative images
that blood supply of the spinal cord is guaranteed by two nal and intraspinal compartment And from this compartment, there are very small arteries, you can see here on this image. The anterior radiculomedullary artery, that gives further
supply to the main spinal cord artery, the anterior spinal artery. So, based on this concept, we developed ischemic preconditioning and that means that we occlude the main stem of several segmental arteries in order to preserve the capability of
paraspinous collateral network to build new arteries and we do that by minimal invasive staged occlusion of the segmental artery and basically this is an entirely endovascular first stage of a staged approach for thoracoabdominal aortic repair to reduce the ischemic injury of the spinal cord.
The procedure performed local anesthesia with a percutaneous trans-femoral access with a small bore sheath, the patient is awake, there has no cerebrospinal fluid drainage and we perform the clinical monitoring of the patient for at least 48 hours after the procedure. I won't go in details about the procedure, Andrej will let
you guide you through, I will show you our data. You can see, here between September 2014 and December 2017 we've treated 57 patients with MISACE in our institution. You can see here the characteristic of the patient. 75% were male with mean age of 69.6 years of age all over they were hypertension, and most of them, 39, had a
extensive Crawford type II and type III aortic aneurysm. The mean aortic diameter was 62.7. Some of them, they had previous repair of the aorta and 94% were atherosclerotic in all age. So, how do we perform the procedure? So, we look, we've, we look at our CT scan of the patient
and we know from the pre-planning where the aorta will be covered. And in this area, we look at the segmental arteries and we count the segmental arteries, we don't only count, also mark the segmental arteries that will be covered by the stent grafts.
And, you can see here in median we had nine open segmental arteries of this area ranging from 2 up to 26. Then we start the coiling procedure and you can see here that 38.6% of patient had only one coiling session, 42.1% had 2 session of Minimally invasive coil embolization and 19.3% of the patient had more than two stage coil.
And you can see here that, between those two coiling sessions, we had mean interval of 60 days. And you can see here that we have performed maximum five sessions per patient and during those sessions we've coiled maximum six segmental arteries and per patient we've coiled up to 19 segmental arteries
and median was number of 5. You can see here distribution of the segmental arteries after MISACE at the level of the planned aortic coverage. With blue, sorry with dark, it's the, they're segmental arteries were already occluded, with grey it's segmental arteries that we've already coiled
and with red is segmental arteries that we've not coiled. Again this is the first initial clinical experience and at the end of the entire coiling procedure, we've occluded median 77.7% of the entire segmental arteries of that level. You can see here the characteristic of the
coiling of session. You can see here that basically between the first and second sessions, they're not too many differences, the third session is quiet quicker and we've no spinal cord ischemia after this coiling sessions and we've some minor complication like quarter of our patient developed
backpain which resolved with NSAIDs, we had lost two coils, we were able to recover and we were unable to occlude one segmental artery in three patients. After seven days but no sooner than that, in order to let the collaterals of spinal cord to develop, we performed the complete aneurysm exclusion of these patients.
You can see here, 55 of our patient were completely excluded in the mean time of 83 days. To mention that, two patients died waiting for the CMD graft due to the cardiac problems not related to the aneurysm pathology. You can see here the characteristic of the TEVAR procedure.
You can see here we performed, all type of stent grafts from tube stent-graft to fenestration branch combined stent graft. In one patient, we've the subclavian coverage on the left side and in 80% of the patients the hypogastric are true or patent.
To mention that, the length of the covered aorta in our cohort was 270 mm. After the complete repair of the thoracoabdominal aortic aneurysm, at 30 days, you can see our result, we've no spinal cord ischemia in this patient, one patient died due to related aneurysm problem.
And by looking at this data, we conclude that the first experience suggest that the minimal invasive segmental artery coil embolization is feasible, safe and in our opinion, effective but can be challenging and it's a new field with a many open questions. And we think that the ultimate proof of this technology
of this procedure requires randomized trial which is currently underway, this PAPA-ARTiS trial, paraplegia prevention in aortic aneurysm repair by thoracoabdominal staging with MISACE. Thank you for your attention.
- Good morning, thank you, Dr. Veith, for the invitation. My disclosures. So, renal artery anomalies, fairly rare. Renal ectopia and fusion, leading to horseshoe kidneys or pelvic kidneys, are fairly rare, in less than one percent of the population. Renal transplants, that is patients with existing
renal transplants who develop aneurysms, clearly these are patients who are 10 to 20 or more years beyond their initial transplantation, or maybe an increasing number of patients that are developing aneurysms and are treated. All of these involve a renal artery origin that is
near the aortic bifurcation or into the iliac arteries, making potential repair options limited. So this is a personal, clinical series, over an eight year span, when I was at the University of South Florida & Tampa, that's 18 patients, nine renal transplants, six congenital
pelvic kidneys, three horseshoe kidneys, with varied aorto-iliac aneurysmal pathologies, it leaves half of these patients have iliac artery pathologies on top of their aortic aneurysms, or in place of the making repair options fairly difficult. Over half of the patients had renal insufficiency
and renal protective maneuvers were used in all patients in this trial with those measures listed on the slide. All of these were elective cases, all were technically successful, with a fair amount of followup afterward. The reconstruction priorities or goals of the operation are to maintain blood flow to that atypical kidney,
except in circumstances where there were multiple renal arteries, and then a small accessory renal artery would be covered with a potential endovascular solution, and to exclude the aneurysms with adequate fixation lengths. So, in this experience, we were able, I was able to treat eight of the 18 patients with a fairly straightforward
endovascular solution, aorto-biiliac or aorto-aortic endografts. There were four patients all requiring open reconstructions without any obvious endovascular or hybrid options, but I'd like to focus on these hybrid options, several of these, an endohybrid approach using aorto-iliac
endografts, cross femoral bypass in some form of iliac embolization with an attempt to try to maintain flow to hypogastric arteries and maintain antegrade flow into that pelvic atypical renal artery, and a open hybrid approach where a renal artery can be transposed, and endografting a solution can be utilized.
The overall outcomes, fairly poor survival of these patients with a 50% survival at approximately two years, but there were no aortic related mortalities, all the renal artery reconstructions were patented last followup by Duplex or CT imaging. No aneurysms ruptures or aortic reinterventions or open
conversions were needed. So, focus specifically in a treatment algorithm, here in this complex group of patients, I think if the atypical renal artery comes off distal aorta, you have several treatment options. Most of these are going to be open, but if it is a small
accessory with multiple renal arteries, such as in certain cases of horseshoe kidneys, you may be able to get away with an endovascular approach with coverage of those small accessory arteries, an open hybrid approach which we utilized in a single case in the series with open transposition through a limited
incision from the distal aorta down to the distal iliac, and then actually a fenestrated endovascular repair of his complex aneurysm. Finally, an open approach, where direct aorto-ilio-femoral reconstruction with a bypass and reimplantation of that renal artery was done,
but in the patients with atypical renals off the iliac segment, I think you utilizing these endohybrid options can come up with some creative solutions, and utilize, if there is some common iliac occlusive disease or aneurysmal disease, you can maintain antegrade flow into these renal arteries from the pelvis
and utilize cross femoral bypass and contralateral occlusions. So, good options with AUIs, with an endohybrid approach in these difficult patients. Thank you.
- Mr Chairman, dear colleagues. I've nothing to disclose. We know that aneurysm or dilation of the common iliac artery is present in almost 20% of cases submitted to endovascular repair and we have a variety of endovascular solution available. The first one is the internal iliac artery
embolization and coverage which is very technically easy but it's a suboptimal choice due to the higher risk of thrombosis and internal iliac problems. So the flared limbs landing in the common iliac artery is technically easy,
however, the results in the literature are conflicting. Iliac branch devices is a more demanding procedure but has to abide to a specific anatomical conditions and is warranted by good results in the literature such as this work from the group in Perugia who showed a technical success of almost 100%
as you can see, and also good results in other registries. So there are unresolved question about this problem which is the best choice in this matter, flared limbs or iliac branch devices. In order to solve this problem, we have looked at our data,
published them in Journal Vascular Interventional Neurology and this is our retrospective observational study involving treatment with either flared limbs or IBD and these are the flared limbs devices we used in this study. Anaconda, Medtronic, Cook and Gore.
And these are the IFU of the two IBD which were used in this study which were Gore-IBE and Cook-ZBS. So we looked at the 602 EVAR with 105 flared limbs which were also fit for IBD. And on the other side, we looked at EVAR-IBD
implanted in the same period excluding those implanted outside the IFU. So we ended up with 57 cases of IBD inside the IFU. These are the characteristics of the two groups of patients. The main important finding was the year age which was a little younger in the IBD group
and the common iliac artery diameter which was greater, again in the IBD group. So this is the distribution of the four types of flared limbs devices and IBD in the two groups. And as you can see, the procedural time and volume of contrast medium was significantly
higher in the IBD group. Complications did not differ significantly however, overall there were four iliac complication and all occurred in the flared limbs group. When we went to late complications, putting together all the iliac complication, they were significantly
greater in the flared limbs group compared with the IBD with zero percent complication rate. Late complications were always addressed by endovascular relining or relining and urokinase in case of infusion, in case of thrombosis. And as you can see here, the late outcome
did not differ significantly in the two groups. However, when we put together all the iliac complication, the iliac complication free survival was significantly worse in the flared limbs group. So in conclusion, flared limbs and IBD have similar perioperative outcomes.
IBD is more technically demanding, needs more contrast medium and time obviously. The complications in flared limbs are all resolvable by endovascular means and IBD has a better outcome in the long term period. So the take-home message of my presentation
is that we prefer IBD in young patients with high life expectancy and in the presence of anatomical risk factors of flared limbs late complications. Thank you for your attention.
- The committee asked me to give an update on the Cook p-Branch device which is in a clinical trial in the United States. This is the disclosures as it relates to this talk. I'm going to discuss the feasibility as well as the pivotal study as you see on this slide. Now these two studies, as you can imagine,
have a different number of patients. The feasibility study was done in 30 patients and, as all studies in the U.S., required a five-year follow-up. And the p-Branch pivotal study is involving 82 patients with also a five-year follow-up, with the objectives really to assess the device's
safety and effectiveness and primary endpoints, treatment at one year. Now, the feasibility study enrolled 30 patients at 10 U.S. sites over a two and a half year period, roughly. So here the mean age was 73 years and maximum aneurysm diameter's 65 millimeters
and proximal neck length with the enrolled patients was 21 millimeters. The distribution of A configuration where the two renal pivot fenestration's are at the same level is 57% and the B configuration which is an offset was 43% of the patients.
About 226 mean operative time, slightly more or close to 70 minutes of fluoro time and about one day in the ICU, and three, four days in the hospital. There were two technical problems, the first two patients enrolled at the same site for the trial,
had the p-Branch deployed below the renal arteries due to difficulty with the cannulation and the case done the following day also had a technical failure by not being able to get in a renal. This prompted an update and some physician training and proctoring so that we actually sent proctors to sites,
and the next 28 cases were all successful. Overall, in the feasibility study, 30 day mortality is 0%. Three deaths in the late phase, after 30 days from a cerebral aneurysm. Dissection at slightly less than a year of a proximal
thoracic aneurysm and cardiomyopathy. Freedom from all-cause mortality was 93% in one year, and 89% at 2 years. No ruptures or surgical conversion to date as of last year, when we locked the data. 28 mean follow-up.
Now, if you look at the renal artery patency, which is what all of us are looking at for these types of studies, you see primary patency of stinted renal arteries for this study is on the left. And if you compare that to the initial p-Branch, a single study that was published last year, very similar.
As well as the ZFEN multicenter trial, you see the patencies are quite similar. What about secondary interventions? If you look at this table, we've plotted out secondary interventions at 30 days, and overall, you see the p-Branch feasibility study
slightly higher, but not statistically significant between that and the p-Branch single-center. And the ZFEN is quite low with the 1%. Overall, the secondary interventions were about a third of the patients in most of these studies. Well, what about the pivotal studies?
They said this is an ongoing trial, it's been going on for about three years, we've had about three quarters of the patients enrolled after three years, and we have 28 active sites. We have data on the first 51 patients enrolled, and you see the high enrollers there on the far right.
The mean age is very similar to the feasibility study. 71 years of age, most patients are male, slightly over six centimeters for the diameter, and approximately one millimeter longer at 22 versus 21. The distribution of A and B is also quite similar, as you see here, slightly more A than B,
anywhere from the 55 to 60% range for most all of these studies. Procedures time with the 28 cites now is very similar, 258 minutes, slightly less than the prior study. And you see the fluro time and days in the ICU and discharge very similar.
At 30 days in those 51 patients, no deaths, no renal or bowel ischemia, no neurologic complications or rupture. There had been 3 occlusions of fenestrated vessels, left and renal artery occlusion at day 23, 23, and 30, so these are most likely technical issues
that the stint is crushed. And we've look at that and we'll continue to monitor that. Two patients had re-intervention subsequently, and no patients developed renal insufficiency renal failure at the time of this analysis. So, overall, patient selection, physican technical
abilities, and proper device training will continue to be important for p-Branch implementation and implantation. The feasibility study, early and intermediate results support its safety and feasibility of off-the-shelf device. Follow-up through five years is ongoing. Enrolled is going to continue for the pivotal study
and currently we need less than 20 cases to complete. Thank you.
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