Chapters
Complex Cases From The Mayo Clinic With Questions And Discussion
Complex Cases From The Mayo Clinic With Questions And Discussion
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Rifampin Soaked Endografts For Treating Prosthetic Graft Infections: When Can They Work And What Associated Techniques Are Important
Rifampin Soaked Endografts For Treating Prosthetic Graft Infections: When Can They Work And What Associated Techniques Are Important
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Terumo Aortic Relay Thoracic Endograft For TEVAR In Complex Aortic Pathology With Angles >90°: Advantages And Results
Terumo Aortic Relay Thoracic Endograft For TEVAR In Complex Aortic Pathology With Angles >90°: Advantages And Results
Gore Tag (Gore Medical) / Valiant (Medtronic) / Zenith Alpha (Cook Medical)RelayPlusstent graft systemTerumo Aortictherapeutic
Invasive Treatment In Patients With Genetically Triggered Aortopathy (Like Marfan’s): When Is Endovascular Treatment Acceptable And When Not
Invasive Treatment In Patients With Genetically Triggered Aortopathy (Like Marfan’s): When Is Endovascular Treatment Acceptable And When Not
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Update On The Advantages, Limitations And Midterm Results With The Terumo Aortic 3 Branch Arch Device: What Lesions Can It Treat
Update On The Advantages, Limitations And Midterm Results With The Terumo Aortic 3 Branch Arch Device: What Lesions Can It Treat
4 branch CMD TAAA deviceacuteAscending Graft Replacementcardiac arrestRelayBranchRepair segment with CMD Cuffruptured type A dissection w/ tamponadestent graft systemTerumo Aortictherapeutic
Value Of Parallel Grafts To Treat Chronic TBADs With Extensive TAAAs: Technical Tips And Results
Value Of Parallel Grafts To Treat Chronic TBADs With Extensive TAAAs: Technical Tips And Results
GORE MedicalGORE VIABAHNL EIA-IIA bypassleft carotid subclavian bypassstent graft systemTBAD with TAAAtherapeutic
How To Perform Endograft Repair Of TAAAs Using Branched Endografts Entirely Via Femoral Access: The Secret Is The Use Of Steerable Sheaths
How To Perform Endograft Repair Of TAAAs Using Branched Endografts Entirely Via Femoral Access: The Secret Is The Use Of Steerable Sheaths
Cook MedicalEndograft Repair using Steerable SheathGore Excluder TAMBE (Gore Medical) / Xtra-Design (Jotec)Irregular Orifice of the Right Renal Arterystent graft systemtherapeuticZenith T-Branch
Octopus Technique To Treat Urgent Or Ruptured TAAAs With OTS Components: What Is It, Technical Tips And Results
Octopus Technique To Treat Urgent Or Ruptured TAAAs With OTS Components: What Is It, Technical Tips And Results
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Role Of Endovascular Treatments For Pediatric Vascular Trauma
Role Of Endovascular Treatments For Pediatric Vascular Trauma
Blunt Thoracic Aortic TraumacookendograftEndovascular StentingZenith Endograft
The Value Of Fish Skin Matrix (Kerecis) And NPWT To Promote Healing Of Vascular Wounds
The Value Of Fish Skin Matrix (Kerecis) And NPWT To Promote Healing Of Vascular Wounds
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Femoral Vein Stenting Lessons Learned
Femoral Vein Stenting Lessons Learned
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Transcript

- [Gustavo] Thanks, good afternoon everybody, thanks for coming to this session, I have a couple of interesting cases I would like to share with you this afternoon. First, I really would like to thank a couple of people, because you know making these videos as you know is very time consuming, so Dr. Bernardo Mandez

who is our fellow and is going to be coming up on Mayo Clinic staffing in July assisted with one of the videos, and also Mrs. Pinaro back from the GE has been of extreme help with several of these videos. These are my disclosures, and the main disclaimer

for this presentation is that I will present true cases where the technology was either applied off label in one case, so outside of the instructions for use in terms of the steps of the procedure, and two, a device that's currently under investigation in an ID study.

So the first patient actually he has become now a fairly common clinical scenario in our practice, this is a 79-year-old male with enlarging bilateral common iliac artery aneurysms after an endovascular aortic aneurysm repair performed with flared iliac limbs in our institution.

This patients vascular history is notable for an EVAR using endurant stent graft in 28 millimeter flared limbs in 2013. He had since the time a small iliac aneurysm which was followed and now measures four centimeters on the right, and 3.5 centimeters on the left.

He had all the cardiovascular risk factors we typically see, including a past smoking history, dilated cardiomyopathy, hypertension, hyperlipidemia, sleep apnea, diabetes, previous inguinal hernia repair, and a previous Whipple procedure for ampulary carcinoma in 2012 with no evidence of recurrent disease.

His medications include beta blockers, statin, ACE-inhibitor, and aspirin. His evaluation was unremarkable, except for the findings on the CTE angiography. So this is the summary of the diameters of the iliac, as you can see, it has enlarged fairly,

quite a bit in the last three years. We planned a percutaneous bilateral endovascular repair using the Gore DrySeal sheaths via total femoral approach without using the brachial approach, and that is the feature of this technique that I would like to illustrate to you today.

So this is the Gore excluder device, it's 23 millimeters in the top, it's 10 centimeters in length and 5.5 centimeters to the flow divider. Now the intended side branch is 16 millimeters in the proximal part and it's 10, 12 or 14.5 distally,

and it deploys hub to tip. This device has a two stage deployment, first you release the port or the side branch, and then you release the extensions to the external iliac artery. Some of the ancillary tools that are important

include availability of flexible sheaths. Initially we used Cook Ansel sheath, we migrated to the DrySeal flexor sheath, we also use a snare, the Indy snare, and again this is the picture of the DrySeal flexor sheath. The first step of the procedure

is to establish through and through femoral access. So we basically snare, a wire, this is a metro wire, establishing right to left through and through access. This second step of the procedure relies on protecting the bifurcation of device by advancing a seven French ansel sheath via the side

of the IB to the contralateral side. Once this sheath is advanced, the dilator is removed, and the 12 French sheath where the IB branch goes through is docked inside the seven French, and advanced up and over the aortic bifurcation. To do this, as you can see on the video,

you use this maneuver of push and pull technique so that there is really no strain across the flow divider of the bifurcated device, really protecting the device from migrating distally. That's a very important technical aspect of the procedure. Once the 12 French sheath is advanced,

the iliac branches is loaded via both wires and deployed so that the portal is approximately a centimeter and half above the internal iliac artery. And then, an 8 French sheath is advanced up and over the bifurcation, the internal is selectively catheterized, and I would recommend to extend the branch using

a balloon expandable stent, rather than the viabahn or the intended side branch for safety reasons, and we can discuss that further. Once the iliac branch is completed, then you extend the repair proximally, using a 27 millimeter flared limb. This is the video of this case that is here in illustrated.

We have now bilateral femoral access, a 16 French DrySeal on the left side, and a 12 French DrySeal on the right side. And we are first going to address the left iliac aneurysm, and then after that, the right iliac aneurysm. First, the seven French sheath is now going up and over the aortic bifurcation, you can see after this is ensnared,

now the 12 French sheath is advanced nicely up and over the bifurcation. Once that sheath is advanced, the IB is loaded, limited in angiography is performed to demonstrate where the original of the internal iliac artery is located, it's very important you don't have wire wrapping

before you actually release the device, and as you can see here now, the IB is deployed. We then advance an eight French sheath via the through and through femoral wire, all the way into the portal of your iliac branch device, and then, using a body catheter system,

selectively catheterize the internal iliac artery, and one of the branches of the internal iliac artery, in our preference the posterior divisional branch of the internal iliac artery. After this, the glide wire is exchanged for an amplatz wire and the seven French sheath is then removed

and re-advanced over the amplatz wire into the internal iliac artery. Note here that the device is now being retracted towards the external, to minimize the length between the exterior of the portal and the origin of the internal, and now a Gore balloon expandable viabahn VBX stent

is being deployed and then post dilated to 14 millimeters. Once this is done, you want to remove the 12 French sheath from up and over the bifurcation. And it's very important that you just don't simply pull that sheath out, but do it carefully, usually by advancing the dilator which allows you to

just remove the sheath over the dilator. In this case the procedure was then completed by placement of the flared limb. Next we basically repeated these steps to do the same in the other side, here there a snare is again used to establish

through and through access, the seven French sheath is again advanced, the 12 French sheath is directed up and over the bifurcation, then the iliac branch is loaded and after limited angiography is now being deployed with the portal, just above the origin of the right internal iliac artery.

And again we repeat the same process after catheterization by doing limited angiography. You can use, also we are using fusion technology here to identify some of the anatomical landmarks and minimize the use of repeated angiography. And after that is documented,

the device is completely deployed, kissing balloons are done in the IB and the branch, however an important caveat here, is that because we are using a balloon expandable stent for the iliac artery, you want to be careful not to collapse that stent, and you want to definitely

deflate that balloon last. Now completing the repair, we restore flow to the legs, and do a completion angiography, and also a combine with high definition to demonstrate patency of both branches as demonstrated here on coronal and the axial view.

On this case, there was unfortunately a small type one endo leak in the left internal, which I left and treated at this point. The follow up computed tomography angiography now demonstrates here patency of the iliac branch device. Okay, Giovanni, I don't know if you want

to stop a little bit? - [Giovanni] Yes, I will propose that we stop and probably we have questions from the audience. - [Martin] So you have iliac branch device on both sides, do you have a reason to not come from above? Because my impression is if you do an extension

of an existing endo graft on both sides, you can place both iliac arteries closer, so you can come from above and connect from above? - [Gustavo] So I mean, Martin, yes, the short answer is, we come from above basically every day, for one or other reason, but certainly brachial access

has it's own limitations, for starters the fact you usually need to do a cut down, of course, people are using the upper cutaneous approach, but it does introduce a whole set of things, and I think that the point is that I want to emphasize is that this is a technique extremely efficient actually,

and effective, and avoids the use of brachial access. So if for some reason you want to avoid, I can tell you it's very very effective to do it this way, as long as you follow certain steps to protect the flow divider of the device. - [Giovanni] From Argentina the next question.

- [Second Questioner] I will tell, you can do that because you have this flexible 12 sheath from Gore. You can't do that with another one. - [Gustavo] No you can do it with the ansel sheath, I think as well, it has to be just a flexible dilator sheath, but I don't think it necessarily

needs to be the Gore, you know, in fact we've done it with the other sheath. I do think it has to be some sort of a flexible dilator, like the ansel's sort of flex dilator that we use for branching the grafts would work probably very well for this,

I think with the rigid dilator I wouldn't try it. The first time I used this, Martin, actually my plan was to do it from the brachial approach, but we decided to do this way, and I was very surprised it worked, we have now treated 15 patients with this,

I just submitted to the Society for Clinical Vascular Surgery and the description of the technique should be coming in the Journal of Endovascular Therapy. - [Third Questioner] Gustavo, what wire did you use to get the sheath up and over? - [Gustavo] What wire?

So the wire I traditionally use for iliac branches is the metro wire, the metro wire, we don't know much but it's used by the GI doctors, it's almost five meters long. It's 480 centimeters long. And that was really what Roy was using

for his iliac branches when I was with him at the Cleveland clinic, and the nice thing about it is that by being so long, the scrub nurse at the end of the table can keep traction on the wire and the surgical team, you and your assistant, don't really have to worry about the fact of the traction,

because there is always somebody at the end of the table putting the traction. I think you can do it with the glide wire, if you prefer. But I've been using that also for the thoracals when we do the brachial femoral access, because it allows so much length for the exchanges.

- [Giovanni] Any other questions? I will propose that we go on with the next case please. - [Gustavo] Hopefully the sequence will work now. So this is a 73 year old male patient with a Stanford B DeBakey three B aortic dissection and chronic enlargement of the thoracic aorta.

This patient's clinical presentation include recurrent admissions for chest pain, he has hypertension, hyperlipidemia and a past smoking history as risk factors. His preoperative assessment consisted with a cardiac stress test, which was negative, ejection fraction of 60%, he does have moderate pulmonary disfunction

with some moderately elevated creatinine and a stage three chronic kidney disease with baseline creatine of 1.6. His vascular exam is essentially unremarkable. A CT angiography of chest, abdomen, and pelvis was obtained, as you can see here on the 3D reconstruction

his ascent aorta is lightly large, his aortic arch is normal, he does have a fairly sizeable entry site to a flow via true and false lumen along the thoracic aorta. The largest diameter is in the proximal thoracic aorta just beyond the subclavian artery.

And the the aorta tapers down at the level of the celiac access. You can see here on sagittal view that indeed there is some modest astasia of the ascent aorta, but his aortic arch is relatively normal size. And I'll show you in a second

the specific diameters of the aorta. The aorta was 4.2 in the ascending, tapering to 3.4 centimeters across the arch, with relatively parallel walls in that segment, enlarging to 6.2 centimeters in the upper thoracic aorta, and then tapering down to 3.2 centimeters

in the distal thoracic aorta. This patient was treated using an investigational arch branch device, the Gore thoracic branch endoprosthesis, which has a single retrograde branch. This device is off the shelf

and currently used on a clinical trial, it has intended diameters of 21 up to 53 millimeters, although many of us including myself would not agree to treat the patient with such a large aortic neck. It has one retrograde branch that accommodates an eight by 20 by 60 millimeter self expandable stent

specially designed for the subclavian artery. It has a distal portal edge that accommodates lengths between 20 to 25 and 40 millimeters and a device length of 10 up to 20 centimeters. This is the patients layout of the CT scan. Our plan included deployment first

of a Gore TBE of 37 by 20 centimeters, second, the side branch to the subclavian artery, and then third, extension of the repair to just above the celiac access with a CTAG. The procedure was done in a hybrid endovascular room using fusion imaging with GE discovery IGS 740.

I do use for these cases a brachial access in the lower brachial artery. With a small incision the brachial artery is exposed, you can also use no brachial access or radial access or percutaneous brachial-radial access if you prefer. One of the first steps is to establish

through and through brachial femoral access. A glide wire is advanced and snaring is using done in the infrarenal aorta or iliac arteries. On this case, we have used the technique of tillocobal, of flushing the device with CO2 to minimize air embolism, and then evidently the CO2 was flushed with normal saline

to avoid any CO2 within the device. The device is then loaded via the brachial-femoral wire and the lunderquist wire which is positioned on the ascent aorta and then the device is advanced and parked within the DrySeal sheath in the groin and allowed to back bleed and to fill up

with blood eliminating or diminishing the rate of air embolism. Again one of the first steps is to make sure you don't have wire wrapping. You see the device is now being advanced into position without wire wrapping and it's very nice to have

that small brachial sheath to allow limited angiography in the subclavian artery to locate the exact origin of the subclavian artery. You can see that we also use fusion image to outline the vessels, once the device is in position, it's then deployed.

One of the technical challenge sometimes is advancement of the 14 flexor sheath via the femoral approach. We found that a useful technique is to actually advance the brachial sheath in a retrograde fashion, and then remove the dilator and use the similar technique as I already described for the iliac branch

to navigate the 14 french sheath in the portal. Again, we used a brachial sheath for retrograde angiography to document to origin of the vertebral artery before the branch is deployed. Once the side branch is deployed into the subclavian artery, the sheath is removed, the side branch should be dilated,

that's done with a non-compliable balloon of 12 millimeters. The portal is dilated as well. Dilation of the aortic component is optional, we tend to avoid it in case of dissections, in this case we felt there was a little bit of narrowing in the aortic device just behind the branch,

so we decided to dilate that segment of the device. We then extended the repair distally towards the celiac access deployed a CTAG stent graft approximately a couple of centimeters just above the celiac access and dilated the attachments of the two stent grafts.

Following this we then document the completion angiography, which is shown here, which revealed patency of the super aortic trunks and retrograde branch with no type one a endo leak, and as expected a type one b endo leak in the chronic dissection. We also obtained here a combine CT,

which again is demonstrated here on axial views and sagittal views, and you can note the architecture of the side branch without a significant compression. You can also look at this architecture of this stent and analyze for any stent compression. This patient has evolved very well without complications,

again he participates in a clinical trial and has recently returned for his first follow up, already showing occlusion of the false lumen in the entire length of the stented segment of the aorta. Thank you.

- Rifampin-soaked endografts for treating prosthetic graf y work? I have no conflicts of interest. Open surgery for mycotic aneurysms is not perfect. We know it's logical, but it has a morbidity mortality of at least 40% in the abdomen and higher in the chest.

Sick, old, infected patients do poorly with major open operations so endografts sound logical. However, the theoretical reasons not to use them is putting a prosthetic endograft in an infected aorta immediately gets infected. Not removing infected tissue creates

an abcess in the aorta outside the endgraft and of course you have to replace the aorta in aorto-enteric fistulas. So, case in point, saccular aneurysm treated with a TEVAR and two weeks later as fever and abdominal pain.

You start out like this, you put an EVAR inside you get an abcess. Ended up with an open ilio-celiac open thoraco with left heart bypass. Had to sew two arches together. But what about cases where you can't

or you shouldn't do open? For example, 44 year old IV drug user, recurrent staph aureus endocarditis, bacteremia, had a previous aorto-bifem which was occluded, iliac stents, many many laparotomies ending in short bowel syndrome and an ileostomy.

CT scan and a positive tag white cell scan shows this. It's two centimeters, it's okay, treat it with antibiotics. Unfortunately, 10 days later it looks like this, so open repair. So, we tried for hours to get into the abdomen. The abdomen was frozen and, ultimately,

we ended up going to endografts so I added rifampin to it, did an aorta union and a fem fem and it looked like this and I said well, we'll see what happens. She's going to die. Amazingly, at a year the sac had totally shrunk. I remind you she was on continuous treatment.

She had her heart replaced again for the second time and notice the difference between the stent at one year to the sac size. So adding rifampin to prosthetic Dacron was first described in the late 1980's and inhibits growth in vivo and in vitro.

So I used the same concentration of 60 milligrams per milliliter. That's three amps of 600, 30 CC's water injected into the sheath. We published this awhile back. You can go straight into the sheath in a Cook.

Looks like this, or you can pre deploy a bit of little Medtronic and sort of trickle it in with an angiocatheter. So the idea that endografts in infected aortas immediately become infected, make it worse. I don't think it's true.

It may be false. What about aorto-enteric fistulas? This person showed up 63 year old hemorrhagic shock, previous Dacron patch, angioplasty to the aorta a few years ago, aorto-duodenal fistula not subtle. Nice little Hiroshima sign

and occluded bilateral external iliac arteries. Her abdomen looked like this. Multiple abdominal hernias, bowel resections, and had a skin graft on the bowel. Clearly this was the option. I'm not going to tell you how I magically got in there

but let's just leave it at that I got an endograft in there, rifampin soaked, sealed the hole and then I put her on TPN. So the idea that you have to resect and bypass, I'll get back to her soon, I think it's false. You don't necessarily have to do it every time. What about aorto-esophageal hemorrhagic shock, hematemesis?

Notice the laryng and esophageus of the contrast, real deal fistula. Put some TEVARs in there, and the idea was to temporize and to do a definitive repair knowing that we wouldn't get away with it. On post update nine, we did a cervical esophagostomy

and diverted the esophagus with the idea that maybe he could heal for a little while. He went home, we were going to repair him later, but of course he came back with fever, malaise, and of course gas around the aneurysm and we ended up having to fix him open.

So the problem with aorto-enteric fistulas is when you put an endograft in them it's sort of like a little boomerang. You get to throw them out and it's nice and it sails around but in the end you have to catch it. So, in the long term the lady I showed you before,

a year and a half later she came back with a retroperitoneal abscess. However, she was in much better shape. She wasn't bleeding to death, she'd lost weight, she'd quit smoking. She got an ax-bi-fem, open resection,

gastrojejunostomy and she's at home. So, I think the idea's, I think it's false but maybe realistically what it is, is that eventually if you do aorto-enteric fistulas you're going to have to do something and maybe if you don't remove the infection

it may make it worse. So in conclusion, endografts for mycotic aneurysms, they do save lives. I think you should use them liberally for bad cases. It could be a bad patient, a bad aorta, or bad presentation. Treat it with antibiotics as long as possible

before you put the endograft in and here's the voodoo, 60 milligrams per mil of rifampin. Don't just put in there, put it in with some semblance of science behind it, put it on Dacron, it may even lead to complete resolution. And I've also added trans-lumbar thoracic pigtail drains

in patients that I literally cannot ever want to go back in. Put 'em in for ten days wash it out. TPN on aorto-enterics for a month, voodoo, I agree, and I use antibiotics for life. Have a good plan B because it may come back in two weeks or two years, deploy them low

or cut out the super renal fixations so you can take them out a little easier. Thank you.

- Thank you Rod and Frank, and thanks Doctor Veeth for the opportunity to share with you our results. I have no disclosures. As we all know, and we've learned in this session, the stakes are high with TEVAR. If you don't have the appropriate device, you can certainly end up in a catastrophe

with a graph collapse. The formerly Bolton, now Terumo, the RelayPlus system is very unique in that it has a dual sheath, for good ability to navigate through the aortic arch. The outer sheath provides for stability,

however, the inner sheath allows for an atraumatic advancement across the arch. There's multiple performance zones that enhance this graph, but really the "S" shape longitudinal spine is very good in that it allows for longitudinal support.

However, it's not super stiff, and it's very flexible. This device has been well studied throughout the world as you can see here, through the various studies in the US, Europe, and global. It's been rigorously studied,

and the results are excellent. The RelayPlus Type I endoleak rate, as you can see here, is zero. And, in one of the studies, as you can see here, relative to the other devices, not only is it efficacious, but it's safe as well,

as you can see here, as a low stroke rate with this device. And that's probably due to the flexible inner sheath. Here again is a highlight in the Relay Phase II trial, showing that, at 27 sites it was very effective, with zero endoleak, minimal stent migration, and zero reported graph collapses.

Here again you can see this, relative to the other devices, it's a very efficacious device, with no aneurism ruptures, no endoleaks, no migration, and no fractures. What I want to take the next couple minutes to highlight, is not only how well this graph works,

but how well it works in tight angles, greater than 90 degrees. Here you can see, compliments and courtesy of Neal Cayne, from NYU, this patient had a prior debranching, with a ascending bypass, as you can see here.

And with this extreme angulation, you can see that proximally the graph performs quite well. Here's another case from Venke at Arizona Heart, showing how well with this inner sheath, this device can cross through, not only a tortuous aorta, but prior graphs as well.

As you can see, screen right, you can see the final angiogram with a successful result. Again, another case from our colleagues in University of Florida, highlighting how this graph can perform proximally with severe angulation

greater than 90 degrees. And finally, one other case here, highlighting somebody who had a prior repair. As you can see there's a pseudoaneurysm, again, a tight proximal, really mid aortic angle, and the graph worked quite well as you can see here.

What I also want to kind of remind everybody, is what about the distal aorta? Sometimes referred to as the thoracic aorta, or the ox bow, as you can see here from the ox bow pin. Oftentimes, distally, the aorta is extremely tortuous like this.

Here's one of our patients, Diana, that we treated about a year and a half ago. As you can see here, not only you're going to see the graph performs quite well proximally, but also distally, as well. Here Diana had a hell of an angle, over 112 degrees,

which one would think could lead to a graph collapse. Again, highlighting this ox bow kind of feature, we went ahead and placed our RelayPlus graph, and you can see here, it not only performs awesome proximally, but distally as well. And again, that's related to that

"S" shaped spine that this device has. So again, A, it's got excellent proximal and distal seal, but not only that, patency as well, and as I mentioned, she's over a year and a half out. And quite an excellent result with this graph. So in summary, the Terumo Aortic Relay stent graph is safe,

effective, it doesn't collapse, and it performs well, especially in proximal and distal severe angulations. Thank you so much.

- Thank you, honored to present this work on behalf of our group at the VA, the Michael E. DeBakey VA in Houston, led by Dr. Kougias. Disclosures are here, Dr. Kougias does consultation for Cook Medical. So compared to EVAR, FEVAR has greater lower extremity ischemic times due to larger sheaths,

visceral cannulation, complexity of procedures. And lower extremity complications have been reported as high as 15%, but there's not been a careful analysis of this. So we decided to look at the incidence of lower extremity sensory or motor deficit

after FEVAR, and to look specifically at lower extremity ischemic time, iliac artery occlusive disease, and lower extremity neurologic impairment after FEVAR. So this is a retrospective study over a four-year period. Early experience with our FEVAR cases was included,

and we generally used bilateral femoral access. Iliac stenotic lesions were dilated when required to allow an 18 or 20 French sheath to be placed. Graft alignment was achieved by centering the graft over at least two sheaths in the visceral arteries

before releasing the diameter-reducing wire. Visceral stents were used for all fenestrations and selectively for some scallops. We used perfusion adjunct techniques selectively, such as antegrade 7 French sheath placement into the FSA or sometimes a Dacron conduit into the common

femoral artery, which allows you to retract the sheath. A primary outcome was neurologic impairment. Secondary outcomes were major amputations and ability to ambulate at 30 days after surgery. We measured continuous lower extremity ischemic time from the time of the large sheath insertion into

the femoral artery until it was removed. If we used perfusion adjuncts, we measured the time from the sheath insertion to the perfusion initiation via the adjunctive modality, and the longest ischemic time for each extremity was recorded. We measured common iliac artery lumen diameters.

It was the distance of inner wall to inner wall, the narrowest segment of each common iliac artery. And we entered this as a binary variable based on eight millimeters. Statistics, we did both uni- and multivariate analysis, and I'll just run through that here quickly.

And we did an interaction model looking at the association between lower extremity ischemic time, size of the residual patent common iliac artery lumen versus neurologic impairment in the lower extremities. So there was 101 FEVAR patients with 202 limbs.

Percutaneously done in 16% of cases, we used perfusion adjuncts based on understanding of the case and how long it was going to take. Conduit in eight cases, and antegrade SFA sheath placement in three cases. The configurations are shown here.

Majority were one scallop and two fens, and the ischemic times are shown there. Operative time was about three hours was the average, but the standard deviation was 122 minutes. You can see the fluid requirements there. We looked at intra- and postoperative transfusions.

Then we looked at patients with neurologic impairment. So there were 18 patients who had some neurologic impairment postoperatively. 12 of these patients has mild sensory loss, eight has complete sensory loss, and only two had motor dysfunction.

The deficits tended to resolve within four days, almost all within 14 days. But we had four limbs with persistent sensory deficits, and only one with a persistent motor deficit. Two patients could not ambulate normally at 30 days. No patient underwent an amputation.

If you look at the univariate analysis, limb ischemic time, common iliac lumen less than eight millimeters, intraoperative blood loss, change in hemoglobin, and total transfusion all seem to indicate lower extremity motor dysfunction or sensory dysfunction.

But on multivariate analysis, there are only two factors: limb ischemic time and common iliac artery diameter less than eight millimeters. If you looked at the interaction model we prepared, if the common iliac artery diameter was less than eight millimeters after about two and

a half hours of continuous ischemia, the incidence of neurologic impairment went up. This went up more slowly if it was more than three hours if the iliac artery diameter is greater than eight millimeters. So, in conclusion, lower extremity permanent

neurologic impairment is very low after FEVAR, but there is a relatively high instance of reversible neurologic impairment associated with two things: extremity ischemic time and the presence of pre-existing occlusive disease in the common iliac artery.

We acknowledge this was a single center study. We weren't able to look at extent of aortic coverage or associated spinal cord ischemia, but we conclude that when you anticipate long ischemic times based on the iliac artery diameter, you should consider adjunctive perfusion techniques.

Thank you.

- Thank you, I have no disclosure for this presentation. Aorotopathy is a different beast as oppose to patients with dissections that we normally see in the elderly population, but we have the same options open surgery, endovascular, and hybrid. If they all meet the indications for surgery so why not open surgery?

We know in high volumes centers the periprocedural mortality acceptable in especially high volume centers. The problem is the experience surgeons are getting less and less as we move into more and more prevalence of endovascular. And this is certainly more acceptable in lower or

moderate high risk patients. So why not be tempted by endovascular in these patients? (to stage hand) Is there a pointer up here? So the problem with aorotopathy is the proximal and distal seal zones and we've already heard some talks today about possible retrograde dissection,

we've also heard about nuendo tear distally and aorotopathy is certainly because of the fragile aorta lend itself to these kinds of problems. But it is tempting because these patients often do very well in the very short term. The other problem with aorotopathy is they often have

dissection with have problems for branch unfenestrated technology and then of course if these dissection septum are near the proximal and distal seal zones, you're going to have a lot of difficulty trying to break that septum with a ballon and possibly causing new

entry tears proximally or distally. Doctor Bavaria and his colleagues from Italy were one of the first ones to do a systematic review and these are not a large number of patients but they combined these articles and they have 54 patients. Again, the very acceptable low operative risk, 1.9%.

But they were one of the first ones to conclude and cation that TEVAR in these patients, especially Marfan's patients in this series carries a substantial risk of early and late complications. They actually cautioned the routine use of endovascular stent grafts.

One of the largest series, again stress, these are not large numbers but one of the largest series was just 16 patients and look at this alarming rate of primary failure. 56% treated successfully, 40% required conversion to open operation and interestingly enough

43% of those patients had mortality. My friend and colleague at the podium, doctor Azizzadeh was given the unbeatable task of arguing for endovascular therapy in Marfan syndrome and the best he can come up with was that midterm follow up demonstrates sizeable numbers of complications but,

he identify area where probably it was acceptable in patients with rupture, reintervention for patch aneurysms and elective interventions in which landing zone was in a synthetic graft. So why not hybrid? Well this seems to be the more acceptable version

of using TEVAR, if you can, in these aorotopathy patients. But this is not a great option because in this particular graft that you see this animation, we're landing in native aortic tissues. So really, what you have to do is you have to combine this and try to figure out a way to create a landing zone,

either proximally or distally and this is a patient and not with Marfan's this time but with Loeys-Dietz, who we had presented recently, previous ascending repair but then presented with horticultural abdominal aneurysm as a result of aneurysm habilitation of a previous dissection and here

you see a large thoracal abdominal aneurysm on the axial and coronal and as many of these patients with aorotopathy express other problems with their multisystem diseases and you can see the patients left lung is definitely not normal there, left lung is replaced with bullae and this is a patient who would not do well

with an open thoracal abdominal repair. So what do you do? You have to create landing zones and in this particular patient, he had a proximal landing zone so we were able to just use a snorkel graft from the mnemonic but distally we had to do biiliac debranching grafts to to all his vistaril arteries

and then land his stent-graft in the created distal zone and as you can see, we had an endoleak approximately and thank goodness that was just from a type II endoleak from the subclavian artery which we were able to take care of with embolization and plugs.

And there is his completion C.T. So not all aorotopathy is the same, this is a patient who presented with a bicuspid aortic valve and a coarctation and I would submit to you, this is not a normal aorta. This is probably a variant of some sort of aorotopathy,

we just don't have a name for it necessarily, and do these patients do well or do worst with endovascular stent-graft, I just don't think we have the data. This particular patient did fine with a thoracic stent-graft but this highlights the importance of following these patients and being honest with the patients family and the

patient that they really do have to concentrate on coming back and having closer follow up in most patients. So in summary, I think endovascular is acceptable in aorotopathy if you're trying to save a life, especially in an acute rupture or in an emergency situation, but I think often we prefer to land these

endovascular stent-graft in synthetic. Thank you very much.

- Thank you, and thanks to Dr. Veith for the opportunity to share some of our data. These are my disclosures, some devices presented here are investigational and I want to acknowledge my friend Gustavo, who actually shared some of the slides that we'll show. And I want to reference some of his papers. So a spinal cord ischemia has been presented here

as a devastating complication, after both open and endovascular repair of thoracoabdominal aortic aneurysms. The spinal drains are routinely used to ameliorate the frequency and also the severity of spinal cord ischemia, the problem with this trains is that they may result inherent morbidity and mortality.

Now, intraoperative neuromonitoring has been used to not only monitor, but also to manage potential cases of spinal cord ischemia, this is a study by the group at the Mayo Clinic, led by Gustavo. 49 patients, of which 90% had thoracoabdominal aortic aneurysms, all these patients have spinal drain splice,

spinal cord ischemia was seen in six patients. But interestingly, 63% of the patients had significant decrease in the amplitude of both motor and somatosensory evoked potentials. And interestingly all of these changes came back to baseline except in one patient once

their lower legs were reperfused. However, and despite all of these papers that have, you know, talk about the use of spinal drains for endovascular reparative thoracoabdominal aortic aneurysms against the effectiveness of the spinal drains has not been shown.

And the aim of our study was to assess the outcomes of spinal cord protection without the routine use of spinal drains. We actually has some complications in this report, we decided that we were going to use only selectively in our series, the device is used for this in patients

were all part of a physician-sponsored investigational device exemption, demonstrating branch devices were used including the drainage device. We use a similar protocol as the one described by the Mayo Clinic group, which rely on permissive hypertension maintaining the maps above 90 or 100,

and the systolic pressures above 140. However, as mentioned, we did not place spinal drains routinely, the spinal drains were only considered in those patients that had persistent motor evoked potential deficits, at the end of the procedure. Once the legs have been reperfused, we did not use

conduits, we did percutaneous access in all patients. But of note, we did use endo conduits in all patients that have significant iliocclusive disease, not only to be able to deliver the device, but also to maintain flow to the lower extremities, to avoid distal ischemia. So 34 patients were enrolled in this study,

all patients had intraoperative neuromonitoring, and select spinal drains were placed. 10 patients, 29%, were extent 4 thoracoabdominal repairs, and 24 were extent type one to three. Important all patients with type one and three thoracoabdominal aneurysms underwent a staged repair.

We use in 20% of the cases off-the-shelf device is specifically the debranch, and 80% underwent custom made devices, all these devices were pre-loaded with wires. So, of these patients, 73 were male, 9% Type I, 38% Type II, 24% were Type III,

and 29% were Type IV. We saw significant changes in the evoked potentials in 80% of the patients. In all of them those changes came back to baseline except in one patient, who actually had a spinal drain at the end of the procedure.

30-day mortality in two patients, spinal drain was required eventually in only four patients, that's 12%. One because of sustained changes in the motor evoked potentials, spinal cord ischemia occurred in four patients, in all cases secondary to hypertension. After a procedure, in these cases two were permanent,

the cases had spinal drain splice, however, the deficit persisted, two had transient paraplegia, one resolved with permissive hypertension, and one resolved with a spinal drainage, I mean, the spinal drain was only effective in half of those patients. We did have two cases of intracranial bleeding,

associated with hypertension. So in conclusions, we don't believe that the spinal drains are necessary in all patients. A standard protocol that relies on perioperative maintenance of adequate blood pressure in intraoperative neuralmonitoring is however required.

And we believe that tight blood pressure control is mandatory to avoid possible complications related to uncontrolled hypertension, thank you.

- Thank you very much. Thank you, Frank, for inviting me again. No disclosures. We all know Onyx and the way it comes, in two formulas. We want to talk about presenter results when combining Onyx with chimney grafts. The role of liquid embolization or Onyx is listed here.

It can be used for type I endoleaks, type II endoleaks and more recently for treatment of prophylaxis of gutters. So what are we doing when we do have gutters? Which is not quite unusual. We can perform a watchful waiting policy, pro-active treatment in high flow gutters,

pro-active treatment low flow gutters, or we can try to have a maximum overlap, for instance with ViaBahn grafts 15 centimeters in length or we can use sandwich grafts in order to reduce these gutters in type I endoleaks. Here, a typical example of a type I leak treated with Onyx.

And here we have an example of a ruptured aneurysim treated with a chimney graft. And here is what everybody means when they're talking about gutters. Typical examples, this is what you get. You can try to coil these

or you can try to use liquid embolization. Here's the end result after putting a lot of coils into these spaces. What are these issues of the chimney-technique type I endoleak? Which are not quite infrequent as you see here.

Most of these resolve, but not all of them. So can we risk to wait until they resolve? And my bias opinion is probably not. Here, the incidents of these type endoleaks is still pretty high. And when you go up to the Arch

the results can even be different. And in our own series published here, type I endoleak at the Arch were as high as 28%. A lot of these don't resolve over time simply because it's a very high flow environment. Using a sandwich technique is one solution

which helps in a lot of cases but not all of these simply because you have a longer outlet compared to a straightforward chimney graft. You can't rely on it. So watchful waiting? There are some advocates who

prefer watchful waiting but in high flow gutters this is certainly not indicated. And the more chimneys you have, like in a thoracoabdominal aneurysm with four chimneys, the less you can wait. You have to treat these very actively,

like you see here, in these high flow areas. Here a typical example, again symptomatic aneurysm with sealing. Here Onyx was used but without any success. So what we did is we had to add another chimney and plus polymer sealing and then we had a good result.

Here some results, only small serious primary gutter sealing using Onyx with good results in a type I leak. But again, this is only a small series of patients. Sandwich technique already mentioned. When you use, like we did here for chimney grafts in the arteries, you do need Onyx otherwise you

always get problems with these gutters and they do not seal over time. Another example where liquid polymer was used. And here again, you see the polymer. The catheter in order to inject the polymer is very difficult to see but with a little bit of experience

you know where you are. And again, here it is, the Onyx, a typical example. Here another example of the Arch, bird beacon effect, extension, chimney graft. Again the aneurysm gets bigger. And so a combination of using proximal extensions

plus chimneys plus liquid embolization solves this problem after quite a long period of time. And here typically is what you see when you inject the Onyx. This does not work in all cases. Here we used Onyx in order to seal up the origin of the end tunnel.

This works very nicely but there is so ample space for improvement and in some cases it's probably better to use a fenestrated branch graft or even the opt two stabler instead of using liquid embolization. Thank you very much.

- The only disclosure is the device I'm about to talk to you about this morning, is investigation in the United States. What we can say about Arch Branch Technology is it is not novel or particularly new. Hundreds of these procedures have been performed worldwide, most of the experiences have been dominated by a cook device

and the Terumo-Aortic formerly known as Bolton Medical devices. There is mattering of other experience through Medtronic and Gore devices. As of July of 2018 over 340 device implants have been performed,

and this series has been dominated by the dual branch device but actually three branch constructions have been performed in 25 cases. For the Terumo-Aortic Arch Branch device the experience is slightly less but still significant over 160 device implants have been performed as of November of this year.

A small number of single branch and large majority of 150 cases of the double branch repairs and only two cases of the three branch repairs both of them, I will discuss today and I performed. The Aortic 3-branch Arch Devices is based on the relay MBS platform with two antegrade branches and

a third retrograde branch which is not illustrated here, pointing downwards towards descending thoracic Aorta. The first case is a 59 year old intensivist who presented to me in 2009 with uncomplicated type B aortic dissection. This was being medically managed until 2014 when he sustained a second dissection at this time.

An acute ruptured type A dissection and sustaining emergent repair with an ascending graft. Serial imaging shortly thereafter demonstrated a very rapid growth of the Distal arch to 5.7 cm. This is side by side comparison of the pre type A dissection and the post type A repair dissection.

What you can see is the enlargement of the distal arch and especially the complex septal anatomy that has transformed as initial type B dissection after the type A repair. So, under FDA Compassion Use provision, as well as other other regulatory conditions

that had to be met. A Terumo or formerly Bolton, Aortic 3-branch Arch Branch device was constructed and in December 2014 this was performed. As you can see in this illustration, the two antegrade branches and a third branch

pointing this way for the for the left subclavian artery. And this is the images, the pre-deployment, post-deployment, and the three branches being inserted. At the one month follow up you can see the three arch branches widely patent and complete thrombosis of the

proximal dissection. Approximately a year later he presented with some symptoms of mild claudication and significant left and right arm gradient. What we noted on the CT Angiogram was there was a kink in the participially

supported segment of the mid portion of this 3-branch graft. There was also progressive enlargement of the distal thoracoabdominal segment. Our plan was to perform the, to repair the proximal segment with a custom made cuff as well as repair the thoracoabdominal segment

with this cook CMD thoracoabdominal device. As a 4 year follow up he's working full time. He's arm pressures are symmetric. Serum creatinine is normal. Complete false lumen thrombosis. All arch branches patent.

The second case I'll go over really quickly. 68 year old man, again with acute type A dissection. 6.1 cm aortic arch. Initial plan was a left carotid-subclavian bypass with a TEVAR using a chimney technique. We changed that plan to employ a 3-branch branch repair.

Can you advance this? And you can see this photo. In this particular case because the pre-operative left carotid-subclavian bypass and the extension of the dissection in to the innominate artery we elected to...

utilize the two antegrade branches for the bi-lateral carotid branches and actually utilize the downgoing branch through the- for the right subclavian artery for later access to the thoracoabdominal aorta. On post op day one once again he presented with

an affective co arctation secondary to a kink within the previous surgical graft, sustaining a secondary intervention and a placement of a balloon expandable stent. Current status. On Unfortunately the result is not as fortunate

as the first case. In 15 months he presented with recurrent fevers, multi-focal CVAs from septic emboli. Essentially bacteria endocarditis and he was deemed inoperable and he died. So in conclusion.

Repair of complex arch pathologies is feasible with the 3-branch Relay arch branch device. Experience obviously is very limited. Proper patient selection important. And the third antegrade branch is useful for later thoracoabdominal access.

Thank you.

- Thank you, Mr. Chairman. Ladies and gentleman. I'd also like to thank Dr. Veith for the kind invitation. This presentation really ties to the presentation of Erik Verhoven, I believe. These are my disclosures. So we basically have, obviously, two problems. We treat a dynamic disease by fairly static means.

One of the problems, a local problem, is aortic neck degeneration which is the problem basically of progression of disease. We know in general if you stent them, if you operate them, if you don't treat them they will just dilate and it's a question of time

whether you have a problem or not. So, they will inevitably, if patients live long enough, cause a change of geometry of the aorta and the branch vessels and that cause obviously, that can cause stent fractures and other problems.

That's just one of many papers Erik also has shown a migrated graft. With his fenestrated grafts showing that the problem is also prevalent in M stents and Z stents, and obviously also in

as in the Fenestrated Anaconda. So I'll talk briefly about our experience. In Vienna where we have treated so far 179 patients with either double, triple, or quadruple fenestrated grafts. Majority nowadays are quadruple in our series

where we have also treated patients with extensions of thoracic stent grafts or extensions further down to the iliac arteries. In these patients we've had relevant neck degenerations in five cases. Where either the branches had issues

or the graft had migrated relevantly. And these basically represent three different faces of the problem. So one is neck degeneration with migration and loss of seal. Certainly the biggest problem that can cause ruptures. That's one of the cases in 2015

what is certainly important is to have a look at the super celiac area of the aorta and you see it's degenerated, it's dilated. So we have a nice ring of aorta at the visceral segment but above it wasn't. And it was a

you see the saddle of the stent graft and one and a half years later the saddle (cough) has flattened out. We've had a stent fracture of the left renal stent.

We screwed it with anchors and fixed the stent graft. We believe that's going to be the solution. We were wrong. Yet anothe leak and a further migration of the case.

So we had to put in a thoracic endograft and bring in a 4 fen and a mono-iliac crossover solution. The other problem would be neck degeneration or progression of disease without migration or loss of seal. As in this case where we have implanted a 4 fen case and you can see here that there is

a diseased proportion of the thoracic aorta. Could look like a penetrating ulcer. And again we had to put in a thoracic stent graft and a 4 fen solution with a mono-iliac ending and a crossover. What's more important, I believe,

is the progression of general, generalized aortic disease. So there is no real migration, as in this case in 2013. You can see a nice saddle and very straight iliac limbs. 2018 you can see that the saddle is actually flattened out. Renal arteries look upwards, so you would actually believe in

a migration of the stent graft. Also if you look at the iliac limbs you can see that they have actually compressed somewhat. But if you look closely at the difference between the ring and the SMA, so that's lateral view, you can see that there is no difference.

The stent graft actually has not migrated. What happened is that the patient developed a thoracic aneurysm of 7.5cm and the whole aorta is not only increased in diameter but also in length. So the whole thing has moved its confirmation without basically a migration of the

not yet. So, Mr Chairman, Ladies a lessons we have learned is- and I could also repeat wh

seal in the healthiest proportion of the aorta. So if you see a nice visceral ring and above that you see a diseased proportion of the aorta, as in this case, where you have already a degenerated thoracic aorta.

You should really treat this as well and not go for a 2 or 3 fen case. And also the progressio the general progression of disease is an issue. So even if you have no migrations

you may end up with real problems and target vessel occlusions or stent graft fractures. Thank you very much

- Thank you Louie, that title was a little too long for me, so I just shortened it. I have nothing to disclose. So Takayasu's arteritis is an inflammatory large vessel vasculitis of unknown origin. Originally described by Dr. Takayasu in young Japanese females.

The in-di-gence in North America is fairly rare. And its inflammation of the vessel wall that leads to stenosis, occlusion or aneurysmal formation. Just to review, the Mayo Clinic Bypass Series for Takayasu's, which was presented last year, basically it's 51 patients, and you can see

the mean age was 38. And you can see the breakdown based on race. If you look at the early complication rate and we look at specific graft complications, you had two patients who passed away, you had two occlusions, one stenosis, one graft infection.

And one patient ruptured from an aneurysm at a distant site than where the bypass was performed. If you look at the late complications, specifically graft complications, it's approximately 40%. Now this is a long mean follow up: this is 74 months, a little over six years.

But again, these patients recur and their symptoms can occur and the grafts are not perfect. No matter what we do we do not get superb results. So, look at the graft outcomes by disease activity. We had 50 grafts we followed long-term. And if you look at the patency, primary patency

right here of active disease versus non-ac it's significantly different. If you look at the number of re-interventions it's also significantly different. So basically, active disease does a lot worse

than non-active disease. And by the way, one of our findings was that ESR is not a great indicator of active disease. So we're really at a loss as to what to follow for active or non-active disease. And that's a whole 'nother talk maybe for another year.

So should endovascular therapy be used for Takayasu's? I'd say yes. But where and when? And let's look at the data. And I have to say, this is almost blasphemy for me

to say this, but yes it should be used. So let's look at some of the larger series in literature and just share them. 48 patients with aortic stenosis fro all were treated with PTA stenting.

All were pre-dilated in a graded fashion. So they started with smaller balloons and worked up to larger balloons and they used self expanding stents in all of them. The results show one dissection, which was treated by multiple stents and the patient went home.

And one retro-paret-tin bleed, which was self limiting, requiring transfusion. Look at the mean stenosis with 81% before the intervention. Following the intervention it was 15%. Systolic gradient: 71 milligrams of mercury versus 14. Kind of very good early results.

Looking at the long term results, ABI pre was .75, increased to .92. Systolic blood pressure dropped significantly. And the number of anti-hypertensive meds went from three to 1.1. Let's look at renal arteries stenosis.

All had a renal artery stenosis greater than 70%. All had uncontrolled hypertension. They were followed with MRI or Doppler follow up of the renal arteries. So, stents were used in 84% of the patients. Restenosis occurred in 50% of them.

They were, all eight were treated again, two more developed restenosis, they ended up losing one renal artery. So at eight years follow up, there's a 94% patency rate. What about supra-aortic lesions? And these are lesions that scare me the most for endovascular interventions.

Carotids, five had PTA, two had PTA plus stent. Subclavian, three PTA, two PTA. One Innominate, one PTA plus stent. One early minor stroke. I always challenge what a minor stroke is? I guess that's one that happens to your ex mother-in-law

rather than your mother, but we'll leave it that way. Long term patency at three years, 86%. Secondary patency at three years, 76%. Fairly good patency. So when Endo for Takayasu's, non-active disease is best. The patient is unfit for open surgery.

I believe short, concentric lesions do better. In active disease, if you have to an urgent or emergent, accept the short term success as a bridge to open repair. If you're going to do endovascular, use graded balloons or PTAs, start small. Supra-aortic location, short inflation times

I think are safer. And these three, for questions for the future. I guess for the VEITHsymposium in three years. Thank you.

- Good Morning. Thank you very much Dr. Veith, it is an honor and I'm very happy to share some data for the first time at this most important meeting in vascular medicine. And I do it in - oops, that's the end of my talk, how do I go to the --

- [Technician] Left button, left, left. - Okay. So, what we heard on Tuesday were some opinions, of course opinions are very important in the medical field, we heard some hypothesis.

But what I think is critical for the decision-making physician is always the facts. And I would like to discuss some facts in relation to CGuard and the state of the field of carotid revascularization today. One of the most important facts for me,

is that treating symptomatic patients is nothing to be proud of, this is not a strength, this is the failure of the system. Unfortunately today we do continue to receive patients on optimum medical therapy

in the ongoing studies, including the paradigm study that I will discuss in more detail. So if you want to dismiss large level scale level one evidence, I think what you should be able to provide methodologically is another piece of large level one scale evidence.

The third fact is conventional carotid stents do have a problem, we heard about this from Dr. Amor. This is the problem of carotid excess of minor strokes, say in the CREST study. The fact # 4 is that Endarterectomy excludes the problem of the carotid block from the equation

so carotid stents should also be able to exclude the plaque, and yes there is a way to do it one of the ways to do it is the MicroNet covered embolic prevention stent system. And there is intravascular evidence from imaging we'll hear more about it later

that yes it can do this effectively but, also there is evidence from now more that 3 studies with magnetic resonance imaging that show the the incidence of ipslateral embolization is very low with this system. The quantity of the material is very low

and also the post procedural emoblisuent issue is practically eliminated. And this is some examples of intervascular imaging just note here that one of the differences between different systems is that, MicroNet can adapt to simple prolapse

even if it were to occur, making this plaque prolapse protected. Fact # 6 that I think is also very important is that the CGUARD system allows routine endovascular reconstruction of the carotid bifurcation and here is what I mean

as a routine CEA-like effect of endovascular procedure you can minimize residual stenosis by using larger balloons and larger pressure's than we would've used with conventional carotid stent and of course there is not one patient that this can be systematically achieved with different types of plaques

different types of protection systems and different patient morphologies Fact # 7 is that the level of procedural risk is the critical factor in decision making lets take asymptomatic carotid stenosis How does a thinking physician decide between

pharmacotherapy and intervention versus isolated pharmacotherapy. The critical factor is the risk of procedure. Part of the misunderstandings is the fact that we talk often of different populations This contemporary data the the vascular patients

are different from people that we see in the street Of coarse this is what we would like to have this is what we do not have, but we can apply and have been applying some of the plaque risk criteria Fact # 8 is that with the CGUARD system

you can achieve, systematically complication level of 1%, peri procedurally and in 30 days There is accumulating evidence from more than 10 critical studies. I would like to mention, Paradigm and Paradigm in-stent study because

this what we have been involved in. Our first 100 patient at 0.9% now in nearly 300 patients, the event rate is 1.2% and not only this is peri procedural and that by 30 days this low event rate. But also this is sustained through out

now up to 3 years This is our results at 36 months you can see note here, very normal also in-stent velocities so no signal of in-stent re stenosis, no more healing no more ISR signal. The outcome Difference

between the different stent types it is important to understand this will be driven by including high risk blocks and high risk patients I want to share with you this example you see a thrombus containing

a lesion so this patient is not a patient to be treated with a filter. This is not a patient to be treated with a conventional carotid stent but yes the patient can be treated endovascularly using MicroNet covered embolic prevention stent and this is

the final result. You can see that the thrombus is trapped behind the stent MicroNet and Final Fact there's more than that and this is the data that I am showing you for the first time today, there are unmet needs on other vascular territories

and CGUARD is perfectly fit, to meet some of those need. This is an example of a Thrombus containing a lesion in the iliac. This is the procedural result on your right, six months follow up angiogram. This is a subclavian with a lot of material here

again you can preform full endoovascular reconstruction look at the precession` of the osteo placement This is another iliac artery, you can see again endovascular reconstruction with normal 6 month follow up. This is another nasty iliac, again the result, acute result

and result in six months. This is another type of the problem a young man presented with non st, acute myocardial infarction you can see this VS grapht here has a very large diameter. It's not

fees able to address the native coronary issue here So this patient requires treatment, how to this patient: the reference diameter is 7.5 I treated this patient with overlapping CGUARD's This is the angio at 3 months , and this is the follow up at 6 months again

look at the precision of the osteo placement of the device ,it does behave like a balloon, expandable. Extending that respect, this highly calcific lesion. This is the problem with of new atherosclerosis in-stent re stenosis is wrongly perceived as

the proliferation of atheroscleroses tissue with conventional stents this can be the growth of the atherosclerotic plaque. This is the subclavian, this is an example of the carotid, the precise stent, 10 years down the line, symptomatic lesion here

This is not re stenosis this is in-stent re stenosis treated with CGUARD and I want to show you the final result at 2 years. I want to thank you for your attention. Say that also, there is the issue of aneurism that can be effectively addressed , Thank you

- Thank you friends who have invited me again. I have nothing to disclose. And we already have published that as far as the MFM could be assumed safe and effective for thoracoabdominal aneurysm when used according to the instruction for use at one, three, and four years. Now, the question I'm going to treat now,

is there a place for the MFM? Since 2008, there were more than 110 paper published and more than 3500 patient treated. 9 percent of which amongst the total of published papers relating the use of the MFM for aortic dissections. So, we went back to our first patients.

It was a 40 year old male Jehovah Witness that I operated in 2003 of Type A dissection and repair with the MFM in 2010 because he had 11 centimeter false aneurysm. Due to his dissection, this patient was last to follow up because he was taking care full time off of

his severe debilitated son. When we checked him, the aneurysm seven years later shrunk from 11 to 4 centimeters wide. And he's doing perfectly well. Then the first patient we treated seven years ago, same patient with Professor Chocron

Type A dissection dissection repair in 2006. Type B treated with MFM in 2010. We already published that at one year that the patient was doing fine. But now, at three and seven years, the patient was totally cured.

The left renal artery was perfused retrogradely by aspiration. That's a principle that has been described through the left iliac artery. So what's next? Next there was this registry

that has been published and out of 38 patients 12 months follow up, there were no paraplegia, no stroke, no renal impairment, and no visceral insult. And at 12 month the results looked superior

to INSTEAD, IRAD and ABSORB studies. This is the most important slide to us because when you look at the results of this registry, we had 2.6 percent mortality at 30 days versus 11 30 and 30.7 no paraplegia, no renal failure, and no stroke vessel

13 to 12.5. 33 and 34 and 13 and 11.8 percent. With a positive aortic remodeling occurring over time with diminishing the true lumen increasing the true lumen and increasing the false lumen.

And so the next time, the next step, was to design an international, multicenter, prospective, non-randomized study. To treat, to use the MFM, to treat the chronic type B aortic dissection. So out of 22 patients to date,

we had mainly type B and one type A with no dissection, no paraplegia, no stroke, no renal impairment, no loss of branch patency, no rupture, no device failure, with an increase in true lumen and decrease in false lumen that was true at discharge.

That was true at one, three, and six and 12 month. And in regards with the branch occluded from the parts or the branches were maintained patent at 12 and all along those studies. So, of course these results need to be confirmed in a larger series and at longer follow up,

yet the MFM seems to induce positive aortic remodeling, is able to keep all branches patent during follow-up, has been used safely in chronic, acute, and subacute type B and one type A dissection as well. When we think about type B dissection, it is not a benign disease.

It carries at 20 percent when it's complicated mortality by day 2 and 25 percent by day 30. 30 percent of aortic dissection are complicated, with only 50 percent survival in hospital. So, TEVAR induces positive aortic remodeling, but still causes a significant 30 day mortality,

paraplegia event, and renal failure and stroke. And the MFM has stabilized decreased the false lumen and increase the true lumen. Keeps all the branch patent, favorize positive aortic remodeling. So based on these data, ladies and gentleman,

we suggest that the MFM repair should be considered for patients with aortic dissection. Thank you very much.

- Sam, Louis, thank you very much. I also kind of reduced the title to make it fit in a slide. Those are my disclosures. We've switched to using a hybrid room routinely a couple of years ago and what happened then is that we started using 3D imaging

to guide us during the procedure using a fusion overlay. Obviously this was a huge benefit but the biggest benefit was actually 3D imaging at the end of the procedure so rather than doing an AP fluoro run, we would do a 3D acquisition in a cone beam CT

and have those reconstructions available to check technical success and to fix any issues. We've been using this technique to perform translumbar type 2 endoleak treatment and what we do is we do a cone beam CT non contrast and we fuse the pre-op CT on top of this cone beam CT

and it's actually quite easy to do because you can do it with the spine but also obviously with the endograft so it's a registration on the graft on top of the endograft and then the software is really straightforward. You just need to define a target in the middle

of the endoleak. You need to define where you want to puncture the skin and then the system will automatically generate to you a bull-eye view which is a view where you puncture the back of the patient and the progression view you obviously see the needle

go all the way to your target. And what is interesting is that if you reach the target and if you don't have a backflow so you're not in the endoleak, you have this stereo 3D software which is interesting because you do two lateral fluoro runs

and then you check the position of the needle and then it shows you on the pre-op CT where you are. So here in this specific patient, I didn't advance the needle far enough. I was still in the aortic wall,

that's why I didn't get backflow so I just slightly advanced the needle and I got backflow and I could finish the embolization by injecting contrast, close and then ONYX to completely exclude this type 2 endoleak. So now let's go to our focus today is fenestrated endograft.

You see this patient that were treated with a fenestration and branches. You can see that the selective angio in the left renal looks really good but if on the cone beam CT at the end of the procedure we actually had a kink on the left renal stent

so because I had depicted it right away at the end of the procedure I could fix it right away so this is not a secondary procedure. This is done during the index procedure so I'll go directly to what we did is we reinflated a ballon,

we re-fed the balloon and then had a nice result but what happen if you actually fail to catheterize? This was the case in this patient. You see the left renal stent is completely collapsed. I never managed to get a wire from the aortic lumen and back into the renal artery

so we position the patient in the lateral position, did a cone beam CT and used the same software so the target is now the renal artery just distal to this crushed renal stent and we punctured this patient back in the target and so you can see is right here

and you can see that the puncturing the back. We've reached the renal artery, pushed a wire through the stent now in the artery lumen and snared the wire and over this through and through wire coming out from the back we managed

to reopen this kinked left renal stent. You can see here the result from this procedure and this was published a couple of years, two years ago. Now another example, you can see here the workflow. I'm actually advancing the needle in the back

of the patient, looking at the screen and you can see in this patient that had a longer renal stent I actually punctured the renal stent right away because at the end of the procedure I positioned another covered stent inside

to exclude this puncture site and then, oops sorry, and then, can we go to the, yeah great thank you. And then I advance the wire again through this kinked renal stent into the endograft lumen and this is a snare from the groin

and I got the wire out from the groin. So you see the wire is coming from the back of the patient here, white arrow, to the groin, red arrow and this is the same patient another view and over this through and through wire

we manged to re advance and reopen this stent and we actually kinked the stent by getting the system of branched endograft through a previous fenestrated repair and fortunately my fellow told me at the end of the procedure we should check the FEVAR

with a cone beam CT and this is how we depicted this kink. So take home message, it's a very easy, straightforward workflow. It's a dedicated workflow that we use for type 2 endoleak embolization. We have this intermediate assessment with Stereo 3D

that helps us to check where we are so with 3D imaging after the learning curve it's become routine and we have new workflows like this way of salvaging a kinked renal stent. Thank you very much for your attention.

- Thanks (mumbles) I have no disclosures. So when were talking about treating thoracoabdominal aortic aneurysms in patients with chronic aortic dissections, these are some of the most difficult patients to treat. I thought it would be interesting

to just show you a case that we did. This is a patient, you can see the CT scrolling through, Type B dissection starts pretty much at the left subclavian, aneurysmal. It's extensive dissection that involves the thoracic aorta, abdominal aorta,

basically goes down to the iliac arteries. You can see the celiac, SMA, renals at least partially coming off the true and continues all the way down. It's just an M2S reconstruction. You can see again the extent of this disease and what makes this so difficult in that it extends

from the entire aorta, up proximally and distally. So what we do for this patient, we did a left carotid subclavian bypass, a left external to internal iliac artery bypass. We use a bunch of thoracic stent grafts and extended that distally.

You can see we tapered down more distally. We used an EVAR device to come from below. And then a bunch of parallel grafts to perfuse our renals and SMA. I think a couple take-home messages from this is that clearly you want to preserve the branches

up in the arch. The internal iliac arteries are, I think, very critical for perfusing the spinal cord, especially when you are going to cover this much. And when you are dealing with these dissections, you have to realize that the true lumens

can become quite small and sometimes you have to accommodate for that by using smaller thoracic endografts. So this is just what it looks like in completion. You can see how much metal we have in here. It's a full metal jacket of the aorta, oops.

We, uh, it's not advancing. Oops, is it 'cause I'm pressing in it or? All right, here we go. And then two years post-op, two years post-op, you can see what this looks like. The false lumen is completely thrombosed and excluded.

You can see the parallel grafts are all open. The aneurysm sac is regressing and this patient was successfully treated. So what are some of the tips and tricks of doing these types of procedures. Well we like to come in from the axillary artery.

We don't perform any conduits. We just stick the axillary artery separately in an offset manner and place purse-string sutures. You have to be weary of manipulating around the aortic arch, especially if its a more difficult arch, as well as any thoracic aortic tortuosity.

Cannulating of vessels, SMA is usually pretty easy, as you heard earlier. The renals and celiac can be more difficult, depending upon the angles, how they come off, and the projection. You want to make sure you maintain a stiff wire,

when you do get into these vessels. Using a Coda balloon can be helpful, as sometimes when you're coming from above, the wires and catheters will want to reflux into that infrarenal aorta. And the Coda balloon can help bounce that up.

What we do in situations where the Coda doesn't work is we will come in from below and a place a small balloon in the distal renal artery to pin the catheters, wires and then be able to get the stents in subsequently. In terms of the celiac artery,

if you're going to stent it, you want to make sure, your wire is in the common hepatic artery, so you don't exclude that by accident. I find that it is just simpler to cover, if the collaterals are intact. If there is a patent GDA on CT scan,

we will almost always cover it. You can see here that robust collateral pathway through the GDA. One thing to be aware of is that you are going to, if you're not going to revascularize the celiac artery you may need to embolize it.

If its, if the endograft is not going to oppose the origin of the celiac artery in the aorta because its aneurysmal in that segment. In terms of the snorkel extent, you want to make sure, you get enough distal purchase. This is a patient intra-procedurally.

We didn't get far enough and it pulled out and you can see we're perfusing the sac. It's critical that the snorkel or parallel grafts extend above the most proximal extent of your aortic endograft or going to go down. And so we take a lot of care looking at high resolution

pictures to make sure that our snorkel and parallel grafts are above the aortic endograft. This is just a patient just about a year or two out. You can see that the SMA stent is pulling out into the sac. She developed a endoleak from the SMA,

so we had to come in and re-extend it more distally. Just some other things I mentioned a little earlier, you want to consider true lumen space preserve the internals, and then need to sandwich technique to shorten the parallel grafts. Looking at a little bit of literature,

you can see this is the PERCLES Registry. There is a number of type four thoracos that are performed here with good results. This is a paper looking at parallel grafting and 31 thoracoabdominal repairs. And you can see freedom from endoleaks,

chimney graft patency, as well as survival is excellent. This was one looking purely at thoracoabdominal aneurysm repairs. There are 32 altogether and the success rates and results were good as well. And this was one looking at ruptures,

where they found that there was a mean 20% sac shrinkage rate and all endografts remained patent. So conclusion I think that these are quite difficult to do, but with good techniques, they can be done successfully. Thank you.

- Thank you very much Germano. Thanks to Dr. Veith for inviting us and allowing us to present this here. This is work that we've done in a group in Hamburg together with Nikolaos Tsilimparis. And these are my disclosures. It's been now, more than 15 years ago

that branched endografting has been introduced as a technique for thoracoabdominal aneurysms. And for about five years we have access to the T-Branch device as we've learned from the presentations before. And as we heard from Mark Farber

there's more companies going into that space. In Europe it's also the JOTEC company, which is CryoLife now, and we will, I believe, see more companies going into this space. So, about access, we've been discussing in the past

very much about whether right or left side is the better, or safer, access for branched TEVAR, and at that moment in this publication from our center, we phrased this, the unavoidable use of an upper extremity access. We show you that we've been believing that it's unavoidable.

But is it really unavoidable? In some cases I believe it should be avoided, because we have aortic branch vessels that are occluded, thrombotic, we have AV-fistulas and LIMA Bypasses that we may risk. And we may have antegrade branches

from previous artery repair which we would judge as almost a no antegrade access option here. So what can we do in those cases? And furthermore, upper extremity access has complications and it comes at a cost.

Not only hematoma and nerve damage, plexus damage at the access site, but also stroke is reported being a complication of arm access. We've looked into our experience from two years and found that about 5% of patients needed

some sort of re-operations from complications of upper extremity access, and this is just one of the more severe complications we had with a brachial on the stick due to too small access vessels. Another point is radiation.

Because radiation also as we've shown here, this is unpublished data, is significantly higher if a operator stands at the arm compared to standing at the groin. Is it really unavoidable? If we think about this as our traditional access,

but how about this? I know this has been used a lot in fenestrated endografting. But we started applying this technology also for branched endografting to avoid upper extremity access. First case that we did was a patient

that had an irregular orifice of the right renal artery and it was only one branch that we didn't want to go through all the hassle with upper extremity access. You see here, steerable sheath. You can very well attach that artery without upper extremity access.

Next case, for fenestrated and branched, then have one branch difficult celiac artery, very small stenotic orifice from a large aneurism, but it was attachable from the groin, a good result. Next case, two branches, two fenestrations. As you can imagine,

it also went well for the SMA and for the celiac with a good result without the need of touching arm, without the need going through the arch. This is a more severe one. This is a redo after EVAR patient with an occluded one-sided iliac lack

and a crossover bypass. This is the SMA. This is the right renal artery. You see that we were able to complete this repair from one access side alone, doing a full four-branch thoracoabdominal repair using steerable sheaths.

This series has been recently published as a case series, but we have extended on that experience. I can tell you in all patients that we tried to do it, it was possible to avoid the upper extremity access. Concluding: Endovascular repair has matured over years

and can, in my view, be considered gold-standard for thoracoabdominal repair. Upper extremity access is avoidable if possible. Success rate of femoral access with steerable sheath is safe. And I thank you very much for your attention.

- Yes, thank you very much. And it's a pleasure to discuss this topic. My disclosure's obvious. And I want, this is the layout and I want to start with some sensible arguments that tell us to chose the best option for our patients and that we have to take extension of disease

into consideration. And for those patients who expect to live longer go for a durable repair. And I want to show you a quick few examples that are important. This is a standard fenestrated graft with a type one

endoleak so an indication mistake that we had to repair with a very complex graft within a branches. And fortunately it went well and now it seals off completely. This is another case and again this standard EVAR. It should probably have never been done.

You can see where the graft lies. And we look at the proximal sealing zone and we like to look at the sagittal images and we want to have a durable repair and here because it's fairly easy we do a full fenestration graft.

This is another case and again I'm appealing at be careful with your indications. You can see the aneurysm and you look at the infrarenal neck while for us this is not a infrarenal neck at all. This is a diseased Aorta. And where in the old days we would probably have done

a standard FEVAR we now aim look at the red line for a longer sealing zone to make sure that it is durable. And this is the CT Scan at five years. You can now probably say that this aneurysm has been cured as this proximal landing zone has been stable for all these years.

And almost the same case with one little difference you can see the infrarenal neck that it none existing. You can see the sagittal view, it seems to tell you yes, a triple FEVAR will work. But we didn't take into account that the descending Thoracic Aorta was dilated.

You can see it here, 36, 37 millimeters. And we planned this triple FEVAR, we were happy with it. But if you follow this patient you will see that if he lives long enough this is not a suitable landing zone. So we should have done a more impressive repair going a little bit higher

because this is a complex case to repair. And we repaired it with another fenestrated graft up to the Thoracic Aorta, as you can see it's not easy. And the end result was fine but this of course is a far more complex and extensive repair. I don't know if I jumped one, yes.

So a little bit of scientific evidence because we moved away from double fenestrated towards triple fenestrated and we asked ourselves is triple and quadruple fenestrated associated with a higher mortality and mobility? And you can see our series here and the updated figures with more than 200 patients in each arm.

But more importantly look at the changes overtime. A standard fenestrated repair in blue has virtually disappeared in our center. And that is because we aim to have a longer sealing zone. You can see the evolution of the sealing zone going from so to speak 25 millimeters to 45 millimeters

to make sure that these patients have a durable repair. If you look at the results while it's fairly simple because there are no statistical significant differences with regard to technical success 30-day mortality was 0.7% in 454 patients so no statistical differences.

You can imagine the target vessel patency are fine. We only have two problems with a SMA, one with each group and all the other SMA's are doing very well. And actually interestingly, no difference in freedom from re-intervention. And if you look at the estimated survival

interestingly at three years the survival was higher in the complex group compared to the standard FEVAR group. But the over statistics don't show any difference of course. So really, my take home message and the lessons we learnt is that standard EVAR not FEVAR, standard EVAR should only be done in good neck anatomy.

For us, triple FEVAR has replaced double FEVAR and if you have problems higher up you better start immediately with quadruple FEVAR to be able to extend later. And the goal of all of that is to achieve more durable results

and an easier repair in case of extension of disease. Thank you very much for your attention.

- Thank you. Thank you again for the invitation, and also my talk concerns the use of new Terumo Aortic stent graft for the arch. And it's the experience of three different countries in Europe. There's no disclosure for this topic.

Just to remind what we have seen, that there is some complication after surgery, with mortality and the stroke rate relatively high. So we try to find some solution. We have seen that we have different options, it could be debranching, but also

we know that there are some complications with this technique, with the type A aortic dissection by retrograde way. And also there's a way popular now, frozen elephant trunk. And you can see on the slide the principle.

But all the patients are not fit for this type of surgery. So different techniques have been developed for endovascular options. And we have seen before the principle of Terumo arch branch endograft.

One of the main advantages is a large window to put the branches in the different carotid and brachiocephalic trunk. And one of the benefit is small, so off-the-shelf technique, with one size for the branch and different size

for the different carotids. This is a more recent experience, it's concerning 15 patients. And you can see the right column that it is. All the patients was considered unfit for conventional surgery.

If we look about more into these for indication, we can see four cases was for zone one, seven cases for zone two, and also four cases for zone three. You can see that the diameter of the ascending aorta, the min is 38,

and for the innominate artery was 15, and then for left carotid was eight. This is one example of what we can obtain with this type of handling of the arch with a complete exclusion of the lesion, and we exclude the left sonography by plyf.

This is another, more complex lesion. It's actually a dissection and the placement of a stent graft in this area. So what are the outcomes of patients? We don't have mortality, one case of hospital mortality.

We don't have any, sorry, we have one stroke, and we can see the different deaths during the follow-up. If we look about the endoleaks, we have one case of type three endoleak started by endovascular technique,

and we have late endoleaks with type one endoleaks. In this situation, it could be very difficult to treat the patient. This is the example of what we can observe at six months with no endoleak and with complete exclusion of the lesion.

But we have seen at one year with some proximal type one endoleak. In this situation, it could be very difficult to exclude this lesion. We cannot propose this for this patient for conventional surgery, so we tried

to find some option. First of all, we tried to fix the other prosthesis to the aortic wall by adjusted technique with a screw, and we can see the fixation of the graft. And later, we go through the,

an arrangement inside the sac, and we put a lot of colors inside so we can see the final results with complete exclusion. So to conclude, I think that this technique is very useful and we can have good success with this option, and there's a very low

rate of disabling stroke and endoleaks. But, of course, we need more information, more data. Thank you very much for your attention.

- I have no disclosures. So I'm going to show you some pictures. Which of the following patients has median arcuate ligament syndrome? A, B, C, D, or E? Obviously the answer is none of these people.

They have compression of their celiac axis, none of them had any symptoms. And these are found, incidentally, on a substantial fraction of CT scans. So just for terminology, you could call it celiac compression

if it's an anatomic finding. You really should reserve median arcuate ligament syndrome for patients who have a symptom complex, which ideally would be post-prandial pain with some weight loss. But that's only I think a fraction of these patients.

Because most of them have sort of non-specific symptoms. So I'm going to say five things. One, compression of the celiac artery is irrelevant in most patients. It's been found in up to 1/3 of autopsies, MRIs, diagnostic angiography, CT.

This is probably about par, somewhere in that 5% or 10% of CT scans that are in asymptomatic patients will have some compression of the celiac axis. The symptoms associated with median arcuate ligament syndrome are non-specific,

and are really not going to tell you whether patients have the disease or not. So for instance, if you look here's like 400 CT scans, 19 of these patients had celiac compression. But the symptom complex in patients

who had abdominal pain for other reasons looked exactly the same as it did for people who had celiac compression. So symptoms isn't going to pull this apart. So you wind up with this kind of weird melange of neurogenic, vascular,

and you got to add a little psychogenic component. Because if any of you have taken care of these people, know that there's a supertentorial override that's pretty dramatic, I think, in some fraction of these people. So if you're not dizzy yet, the third thing I would say,

symptom relief is not predicted by the severity of post-operative celiac stenosis. And that's a little distressing for us as vascular surgeons, because we think this must be a vascular disease, it's a stenotic vessel. But it really hasn't turned out that way, I don't think.

There's several papers, Patel has one just in JVS this month. Had about a 66% success rate, and the success did not correlate with post-op celiac stenosis. And here's a bigger one,

again in Annals of Vascular Surgery a couple years ago. And they looked at pre- and post-op inspiratory and expiratory duplex ultrasound. And basically most patients got better, they had an 85% success rate. But they had patients,

six of seven who had persistent stenosis, and five of 39 who didn't have any symptoms despite improved celiac flow. So just look at this picture. So this is a bunch of patients before operation and after operation,

it's their celiac velocity. And you can see on average, their velocity went down after you release the celiac, the median arcuate ligament. But now here's six, seven patients here who really were worse

if you looked at celiac velocity post-op, and yet all these people had clinical improvement. So this is just one of these head scratchers in my mind. And it suggests that this is not fundamentally a vascular problem in most patients. It goes without saying that stents are not effective

in the presence of an intact median arcuate ligament. Balloon expandable stents tend to crush, self-expanding stents are prone to fracture. This was actually published, and I don't know if anybody in the audience will take credit for this.

This was just published in October in Vascular Disease Management. It was an ISET online magazine. And this was published as a success after a stent was put in. And you can see the crushed stent

because the patient was asymptomatic down the road. I'm not discouraging people from doing this, I'm just saying I think it's probably not a great anatomic solution. The fifth thing I'd say is that comorbid psychiatric diagnoses are relatively common

in patients with suspected median arcuate ligament syndrome. Chris Skelly over in Chicago, they've done an amazing job of doing a very elaborate psych testing on everybody. And I'll just say that a substantial fraction of these patients have some problems.

So how do you select patients? Well if you had a really classic history, and this is what Linda Riley found 30 years ago in San Francisco. If they had classic post-prandial pain with real weight loss and a little bit older patient group,

those people were the easiest and most likely to have a circulatory problem and get better. There are some provocative tests you can do. And we did a test a few years ago where we put a catheter in the SMA and shoot a vasodilator down,

like papaverine and nitroglycerin. And I've had patients who spontaneously just said, "That's the symptoms I've been having." And a light bulb went off in our head and we thought, well maybe this is actually a way you're stealing from the gastroduodenal collaterals.

And this is inducing gastric ischemia. I think it's still not a bad test to use. An alternative is gastric exercise tonometry, which is just incredibly elaborate. You got to sit on a bicycle, put an NG tube down to measure mucosal pH,

get an A-line in your wrist to check systemic pH, and then ride on a bike for 30 minutes. There's not many people that will actually do this. But it does detect mucosal ischemia. So for the group who has true circulatory deficiency, then this is sort of a way to pick those people up.

If you think it's fundamentally neurogenic, a celiac plexus block may be a good option. Try it and see if they react, if maybe it helps. And the other is to consider a neurologic, I mean psychologic testing. There's one of Tony Sadawa's partners

over at the VA in Washington, has put together a predictive model that uses the velocity in the celiac artery and the patient's age as a kind of predictive factor. And I'll let you look it up in JVS. Oddly enough,

it sort of argues again that this is not a circulatory problem, in that the severity of stenosis is sort of inversely correlated with the likelihood of success. So basically what I do is try to take a history,

look at the CTA, do inspiratory and expiratory duplex scans looking for high velocities. Consider angiography with a vasodilator down the SMA. If you're going to do something, refer it to a laparoscopist. And not all laparoscopists are equal.

That is, when you re-op these people after laparoscopic release, you often times find a lot of residual ligament. And then check post-operative duplex scans, and if they still have persistent symptoms and a high-grade stenosis,

then I would do something endovascular. Thank you.

- Thank you very much for the presentation. Here are my disclosures. So, unlike the predecessor, Zenith Alpha has nitinol stents and a modular design, which means that the proximal component has this rather gentle-looking bear stents and downward-looking barbs.

And the distal part has upward-looking barbs. And it is a lower-profile device. We reported our first 42 patients in 2014. And now for this meeting we updated our experience to 167 patients operated in the last five years.

So this includes 89 patients with thoracic aneurysms. 24 patients in was the first step of complex operations for thoracoabdominals. We have 24 cases in the arch, 19 dissections, and 11 cases were redos. And this stent graft can be used as a single stent graft,

in this case most of the instances the proximal component is used or it can be used with both components as you can see. So, during the years we moved from surgical access to percutaneous access and now most of the cases are being done percutaneously

and if this is not the case, it's probably because we need some additional surgical procedures, such as an endarterectomy or in cases of aorto-iliac occlusive disease, which was present in 16% of our patients, we are going to need the angioplasty,

this was performed in 7.7% of cases. And by this means all the stent grafts were managed to be released in the intended position. As far as tortuosity concerned, can be mild, moderate, or severe in 6.6% of cases and also in this severe cases,

with the use of a brachio-femoral wire, we managed to cross the iliac tortuosity in all the cases. Quite a challenging situation was when we have an aortic tortuosity, which is also associated with a previous TEVAR. And also in this instances,

with the help of a brachio-femoral wire, all stent grafts were deployed in intended position. We have also deployed this device both in chronic and acute subacute cases. So this can be the topic for some discussion later on. And in the environment of a hybrid treatment,

with surgical branching of the supoaortic tranch, which is offered to selected patients, we have used this device in the arch in a number of cases, with good results. So as far as the overall 30-day results concerned, we had 97.7% of technical success,

with 1.2% of mortality, and endoleaks was low. And so were reinterventions, stroke rate was 1.2%, and the spinal cord injury was 2.4%. By the way we always flash the graft with CO2 before deployment, so this could be helpful. Similar results are found in the literature,

there are three larger series by Illig, Torsello, and Starnes. And they all reported very good technical success and low mortality. So in conclusion, chairmen and colleagues, Zenith Alpha has extended indications

for narrow access vessels, provide safe passage through calcified and tortuous vessels, minimize deployment and release force, high conformability, it does retain the precision and control of previous generation devices,

however we need a longer term follow up to see this advantages are maintained over time. Thank you very much.

- This is from some work in collaboration with my good friend, Mike Dake. And, a couple of years of experience at Stanford now. First described by Kazy? years ago. This technical note of using multiple main-body endographs in a sandwich formation.

Up at the top but, then yielding multiple branches to get out to the visceral vessels and leaving one branch for a bifurcated graft. We've sort of modified it a little bit and generally either use multiple

grafts in order to create a branch the celiac and SMA. Left the celiac sometimes for a chimney, but the strategy really has been in one of the limbs to share both renals and the limb that goes down to the legs. We noticed early on that this really was not for

non-operative candidates, only for urgent cases and we recognize that the visceral branches were the most important to be in their own limb. I'll just walk you through a case. 6.8 centimeter stent for foraco above

the prior opened repair. The plan drawn out here with multiple main bodies and a second main body inside in order to create the multiple branches. The first piece goes in. It's balloon molded at the level of pulmonary

vein with enough length so that the ipsalateral limb is right next to the celiac. And we then, from above get into that limb and down into the celiac vessel and extend with either a limb or a viabahn. Next, we deploy a second main body inside

of the gate, thus creating now another two limbs to work through. And then through that, extend in its own branch a limb to the SMA. This was an eight by 79 vbx. Then we've got a third limb to go through.

We put a cuff that measures about 14. This is the math so that the double renal snorkle plus the main body fills up this hole. Now, double sheath access from above, looking for both renals. Sheaths out into both renals with viabahns

inside of that. Deployment of the bottom device and then a final angiogram with a little bit of a gutter that we often see when we have any kind of parallel graft configuration. Here's the post-op CT scan wherein

that limb is the two shared renals with the leg. This is the one year post-op with no endo leaks, successful exclusion of this. Here's another example of one of an eight and a half centimeter stent three thorico similar strategy, already with an occluded

celiac. Makes it a little bit easier. One limb goes down to the superior mesenteric artery and then the other limb then is shared again bilateral renals in the lower main body. Notice in this configuration you can get all the way up to the top then by putting a thoracic component

inside of the bifurcated subabdominal component. There's the final CT scan for that. We've spent some time looking at the different combinations of how these things will fill up to minimize the gutters through some more work. In collaboration with some friends in Kampala.

So we've treated 21 patients over the last couple of years. 73 years of age, 48 percent female usual comorbid factors. Oh, I thought I had more data there to show you. O.K. I thought this was a four minute talk.

Look at that. I'm on time. Octopus endovascular strategy is a feasible off the shelf solution for high risk patients that can't undergo open repair. You know obviously, sort of in this forum and coming to this meeting we see what's

available outside of the U.S. and I certainly am awaiting clinical trial devices that will have purpose specific teacher bi-graphs. The end hospital morbidity has still been high, at four percent. The one year survival of 71 percent in this select

group of 21 patients is acceptable. Paraplegia is still an issue even when we stage them and in this strategy you can stage them by just doing the top part plus the viscerals first and leaving the renals for another day. And branch patency thus far has been

in the short term similar to the purpose specific graft as well as with the parallel graft data. Thank you.

- Good afternoon. So as we've already heard, traumatic injuries are the leading cause of death and disability in children over the age of one. Fortunately, these types of injuries are relatively infrequent, most commonly involving the lower extremities, for example femur fractures,

causing disruption of the SFA or popliteal artery, or the upper extremities, supracondylar humeral fractures will cause damage to the axial or to the brachial artery. Retrospective review of a children's registry from 1993-2005 with 103 patients all of whom were under the age of 18, most were males.

The majority are penetrating wounds. And most frequently, the extremities were involved. Open surgical repair was favored, primary repair when possible, vein patches for use for those under the age of six, and an interposition graft or bypass was used

for those over the age of 12. Non-operative management was selectively chosen in about 10%, and the outcome in this cohort, 10% mortality, 11 amputations, and limb length discrepancy did become a problem over time, necessitating revascularization in 23%.

A nationwide Swedish registry from 1987-2013 looked at 222 patients, children under 15. In this scenario, 2/3 were male, 2/3 had blunt trauma. Once again, upper extremity injuries were more commonly seen in those under 10. Lower extremity injuries more frequently seen

in those between the ages of 11-15. With that cohort that we talked about, 96% were treated with open surgical repair, similar to what we saw before. Interposition grafts, vein patches for the young, and primary repair whenever possible. However, endo therapy was introduced in this scenario,

with eight patients undergoing intervention for axillary, subclavian artery, iliac, and aortic trauma. A summary of four large series was pooled here, and essentially shows you once again the majority of the injuries are in the extremities. The gold standard to date remains open surgical repair,

either with patch, endo anastomosis, or interposition graft, depending on the age and the location. Lajoie presented this abstract, which is a single center retrospective review, nine years, 60 patients, all under the age of 18. And once again with vascular trauma pediatric group,

majority of treatment is with open, however 16% underwent endovascular intervention with embolization, stents, and stent grafts utilized. None of the stents were implanted in anyone under the age of 13. Follow-up six weeks showed no difference

in the amputation rates or the mortality rates, however reinterventions were certainly higher in those who underwent endovascular therapy. National Trauma Databank from 2007-14 of pediatric trauma under the age of 16. 35,000, so it's a very large cohort.

And you're going to see here, it's not just a trend. This was statistically significant. There is an increase endovascular therapy utilization across the board in that time frame, and specifically for blunt trauma, increasing from 5.8% up to 15.7%.

And what you can take away from this is that the increased endovascular therapy was utilized in children over 12, larger hospitals, level one trauma centers, and those who resided in northeast. In addition to that, those who had a higher

injury severity score also underwent endovascular therapy. The most common procedures, embolization of the internal iliac, and TEVAR for blunt aortic trauma. Unfortunately, despite this, the in-hospital survival failed to improve.

So now there's a plethora of data out there, and multiple single-site institutional reviews of their own experience. Here's what I can say. I think there are some select indications for which endovascular therapy appears to be advantageous.

Without question, as you've heard already, the blunt thoracic aortic trauma. Here's a 17-year-old, fell from a seven-story building and successfully underwent endovascular intervention. Another case, a 16-year-old gunshot wound to the thigh, injury to the profunda femoris was a large

false aneurysm in the anteromedial thigh, who underwent coil embolization successful exclusion of this area where the pseudoaneurysm happened to be, but maintained perfusion through the SFA and the remaining branches of the profunda. Is there a role here for blunt femoral trauma in the child?

Well, I'm not a big fan of it, doing it in adults, but there is a paper on it. 13-year-old popliteal artery trauma, high ISS score, this occlusion was recanalized and a self-expanding stent placed. And I will note that a bridging technique was utilized.

Once the other injuries were addressed, the patient underwent bypass. 12-year-old with polytrauma, iatrogenic orthopedic screw injury to the SFA, successfully treated with a Jomed stent, and then planned bridging procedure,

who underwent open repair a few days later with an interposition vein graft from the contralateral leg. One more case, 14-year-old polytrauma, self-expanding covered stent placed for an axillary artery injury, and this was a planned procedure as a bridging technique. He, unfortunately expired prior to that opportunity

to perform the bridging technique on him with a bypass. So, in summary, I do think pediatric vascular injuries are uncommon. Open repair, once again, remains the gold standard. Endovascular therapy appears to be increasing, especially TEVAR and embolization.

Endovascular therapy in the extremities is an option as a bridge in older people over 12 who have higher ISS scores. And a nationwide pediatric database for arterial trauma would be beneficial. Thank you.

- Thank you Dr. Melissano for the kind interaction. TEVAR is the first option, or first line therapy for many pathologies of the thoracic aorta. But, it is not free from complications and two possible complications of the arch are the droop effect and the bird-beak. I was very interested as Gore came up with the new

Active Control System of the graft. The main features of this graft, of this deployment system are that the deployment is staged and controlled in putting in the graft at the intermediate diameter and then to the full diameter. The second important feature is that we can

optionally modify the angulation of the graft once the graft is in place. Was very, very interesting. This short video shows how it works. You see the graft at the intermediate diameter, we can modify the angulation also during this stage

but it's not really used, and then the expansion of the graft at the full diameter and the modification of the angulation, if we wished. This was one of the first cases done at our institution. A patient with an aneurysm after Type B dissection. You see the graft in place and you see the graft after

partial deployment and full deployment. Perhaps you can appreciate, also, a gap between the graft and the lesser curvature of the arch, which could be corrected with the angulation. As you can see here, at the completion angiography we have an ideal positioning of the graft inside the arch.

Our experience consisted only on 43 cases done during the last months. Mostly thoracic aneurysm, torn abdominal aneurysm, and patients with Type B aortic dissection. The results were impressive. No mortality, technical success, 100%,

but we had four cases with problems at the access probably due to the large bore delivery system as you can see here. No conversion, so far and no neurological injury in this patient group. We have some patients who came up for the six months follow-up and you see here we detected one Type 1b endoleak,

corrected immediately with a new graft. Type II endoleak which should be observed. This was our experience, but Gore has organized all the registry, the Surpass Registry, which is a prospective, single-arm, post market registry including 125 patients and all these patients

have been already included in these 20 centers in seven different countries in Europe. This was the pathology included, very thorough and generous, and also the landing zone was very different, including zone two down to zone five. The mean device used per patient were 1.3.

In conclusion, ladies and gentlemen, the Active Control System of the well known CTAG is a really unique system to achieve an ideal positioning of the graft. We don't need to reduce the blood pressure aggressively during the deployment because of the intermediate diameter

reached and the graft angulation can be adjusted in the arch. But, it's not reversible. Thank you very much for your attention.

- Okay, thank you very much. I appreciate the invitation from Dr Veith to discuss this technique and really, this is a how to do it technique. These are my disclosures. So we know that if you're doing a type B dissections that are chronic and you're going to use a fenestrated

device often times you have vessels that are on the false lumen that are not easily accessible. You can see in this picture up above, here's you're flap, this is the right renal artery across the fenestration and you can't really see the actual original fenestration.

There can also be some misalignment between the natural fenestration and where you want to put your fenestration. So this technique allows us to create a neo-fenestration at your site of choice. So here's our stent graft planning in this particular patient.

Here's the dissection flap, here's our graft in the true lumen with the SMA and celiac and the right renal. We've placed the fenestration for the left renal right opposite the left renal artery. And this is a schematic representation of

our in press article. Basically once you've accessed the bottom of the graft you can use a steerable directional sheath and put it right at the level of your fenestration. Use the power wire from Baylis, and what you do is put it right up against the graft.

It's like a cautery, you step on the pedal, it gives a one second burst and that goes across the flap. You can then widen it and then connect your stent graft. This is an example of one of our early cases. Here you can see injection in the true lumen with the right renal, you can't see the left renal,

that's bowel gas and another one of the true lumen branches. You can see with the fusion imaging we've now been able to put the graft, the right renal and the graft expanded. Here you can see an injection and we've got our catheter right up against the left renal fenestration. And here you can next see, the power wire,

the tip of the power wire is just at the edge of the catheter. And if you step on the pedal you can see that the power wire goes across into the false lumen right near here, you can inject your false lumen, you can see your renal

and after that you can see that we've now accessed the artery. We balloon it and then stent it. So these are the tools that are required. You need the power wire generator, you need the power wire itself,

you need a pad on the patient just like a cautery pad, and an Oskar or other steerable sheath is very effective in helping you. A short pulse in one second is usually enough to cross the lumen. Here's a second example.

A patient again with a false lumen, the right renal artery is the one this particular time. You can see the dissection flap is here. We planned the fenestration right opposite the renal artery.

And you can see here similar technique with the catheter. The power wire is already actually been deployed across the channel and then put in place. So this is a relatively simple technique that you can use to access false lumen branches. It allows planning the fenestration on your pre-op plan

close to the target vessel, and it assists you when the natural fenestration is not visible, or misaligned. And it uses an existing technique that we've used for left subclavian in situ fenestration and for some aortic dissection acute cases where you need to fenestrate the false lumen.

Thank you.

- Mister Chairman, ladies and gentlemen. Good morning. I am excited to present some of the data on the new device here. These are my disclosure. There are opportunities to improve current TEVAR devices. One of that is to have a smaller device,

is a rapid deployment that is precise, and wider possibilities to have multiple size matrix to adapt to single patient anatomy. The Valiant device actually tried to meet all these unmet needs, and nowadays the Navion has been designed on the platform

of the Valiant Captivia device with a completely different solution. First of all, it's four French smaller than the Valiant Captivia, and now it's 18 French in outer diameter for the smallest sizes available.

The device has been redesigned with a shorter tip and longer length of the shaft to approach more proximal diseases, and the delivery system deploys the graft in one step that is very easy to accomplish and precise.

The fabric has been changed with nowadays the Navion having the multi-filament weave of the Endurant that already demonstrates conformability, flexibility, and long-term durability of the material. It's coming with a wide matrix of options available. In terms of length, up to 225 mm.

Diameters as small as 20 mm, and tapered device to treat particular anatomical needs. But probably the most important innovation is the possibility to have two proximal configuration options: the FreeFlo and the CoveredSeal.

Both tied to the tip of the device with the tip-capture mechanism that ensures proximal deployment of the graft that is very accurate. This graft is being under trial in a global trial

that included 100 patients all over the world. The first 87 patients have been submitted for primary endpoint analysis. 40% of the patients were females. High risk patients showed here by the ASA class III and IV. Most of the patients presented

with a fusiform or saccular aneurysm, and the baseline anatomy is quite typical for these kinds of patients, but most of the patients have the very tortuous indices, both at the level of the access artery tortuosity and the thoracic aorta tortuosity.

Three-fourths of the patients had been treated with a FreeFlo proximal end of the graft, while one-fourth with the CoveredSeal. Complete coverage of the left subclavian occurred in one-fifth of the patients. Almost all had been revascularized.

Procedure was quite short, less than one and half hour, percutaneous access in the majority of cases. There were no access or deployment failures in this series. And coming to the key clinical endpoints, there were two mortality reported out of 87 patients.

One was due to the retrograde type A dissection at day one, and one was not device related almost at the end of the first month. Secondary procedures were again two. One was in the case of retrograde type A dissection, and the second one in a patient

that had an arch rupture due to septicemia. Type 1a endoleak was reported in only one case, and it was felt to be no adverse event associated so was kept under surveillance without any intervention. Major Adverse Events occurred in 28% of the cases. Notably four patients had a stroke

that was mild and not disabling, regressing in two weeks. Only one case of spinal cord ischaemia that resolved by drainage and therapy in 20 days. In summary, we can say that the design enhancement of Valiant Navion improved upon current generation TEVAR.

Acute performance is quite encouraging: no access or deployment failure, low procedural and fluoro times, low rate of endoleaks, Major Adverse Events in the range expected for this procedure.

Nowadays the graft is USA FDA approved as well as in Europe CE mark. And of course we have to wait the five years results.

- Dear Chairman, dear ladies and gentlemen, thank you for the chance to present these data here. As opposed to United States, this is not first-line therapy in Germany. And I would like to show you some results with the Omega-3-enriched matrix, which is a little bit special.

It's made from fish skin from Atlantic cod, and it's an acellular matrix, which can be used as a xenogeneic skin graft for hard-to-heal wounds in different locations. Some advantages of using fish skin as opposed to a porcine skin or even human skin

is it's a gentle processing possible, it preserves the lipids, which is very important. I think the Omega-3 is a very important feature of this and it preserves the structure. And there's also very little risk of disease transmission, which is

always a matter of concern in xenogeneic materials. And how does it work? The Omega-3 fatty acid has some anti-inflammatory effect by mediating an inhibitor, a new inhibitor. It's called the NLRP3 inhibition,

which is necessary for IL-1 beta activation of cytokine, which is used for inflammation. And so this fish skin is also reducing general inflammation in the surface. So how is this application done? So you see a hard-of-heal wound,

which has to be a little bit clean and infection-free if possible, but it doesn't heal completely. So the fish skin is applied, and it can be covered with polyurethane foam, or even with NWPT with vacuum therapy.

And it takes several treatments. The advantage is it's weekly dressing changes. That means it's possible to do it on an outpatient basis, and I think this is the way it's done mostly in United States. So these are inpatients with very complicated wounds.

23 patients with 25 vascular wounds in different locations. Two in the thigh, seven in the distal calf, 14 in the foot, and two even in the hand. And the time to heal took nine to 41 weeks, so we have to be a little bit patient and stubborn to really wait for the effect of this fish skin.

And in average, you can see here, in some patients, three are enough, but in some patients 26 treatment cycles were necessary. This is just to show you the spectrum of patients treated in the last four years. Not very many, 15 out of 25 only, was complete healing.

This is from three hospitals in Germany, from Hamburg, Mainz, and our hospital in Karlsruhe. And you see here the rate of complete healing is only almost half of them. Here, this is an example, typical example of what we see. This wound became necrotic and dehiscent, and then

after debridement and some cleaning it looks like this. And then it can be treated with the fish skin. It looks a little bit strange if you do the first dressing change, but this is the way it should look. And after a while, this took 33 weeks, but then this foot healed, and there was

no major amputation necessary in this patient, which is the aim of this therapy, actually. This is a very terrible example of steal syndrome in a dialysis patient with a necrotic hand which had to be amputated in an emergency procedure.

And the question was: could this hand be saved somehow? So this was also treated with Omega-3 matrix, and this is the final result, but this hand is not functional, so it needs some additional plastic surgery. But I think after these wounds are healed,

before that no plastic surgeon would do anything with an extremity like this. These are some more examples of the healing. And you see here the curve, how long it takes to heal for these wounds: up to 12 or 14 weeks. This is kind of the average, three months.

There was a publication before with a few similar, even less cases, 18 cases, from United States, which showed complete healing only in three of 18 patients, which is a little bit disappointing, but the primary goal is to get a stable wound

and to avoid amputation, actually. You get a really significant decrease of wound surface, so our results actually were even more successful than this first publication, that there is no much more data available from literature. This is a very special example here,

from presternal necrotic skin flap, which was also treated with Kerecis Omega3 and with mesh graft in the end. So this was a very special case which also was healing. Here you see the time to heal again. It takes a long time, up to 100 days for the healing.

And you see the Hamburg cases here, the wound reduction to 20%, but with some cases 60-80%, and only half of the occasions really complete healing. So in summary, in the shortness of time, summarize that Omega-3 wound matrix is,

for us at least, a innovative biological decellularized wound dressing from cod skin, which works in complicated wounds, in the lower limbs especially. And before they are applicated, there needs to be an effective debridement,

adequate tissue perfusion, and infection control. And weekly dressing changes are absolutely sufficient, so this means that outpatient treatment is possible. Thank you very much for your attention.

- Thank you, Mr. Chairman. Good morning ladies and gentleman. I have nothing to disclose. Reportedly, up to 50 percent of TEVARs need a left subclavian artery coverage. It raises a question should revascularization cover the subclavian artery or not?

It will remain the question throughout the brachiograph available to all of us. SVS guidelines recommend routine revascularization in patients who need elective TEVAR with the left subclavian artery coverage. However, this recommendation

was published almost ten years ago based on the data probably even published earlier. So, we did nationwide in patient database analysis, including 7,773 TEVARs and 17% of them had a left subclavian artery revascularization.

As you can see from this slide, the SVS guideline did affect decision making since it was published in 2009, the left subclavian artery revascularization numbers have been significantly increased, however, it's still less than 20%.

As we mentioned, 50% of patient need coverage, but only less than 20% of patient had a revascularization. In the patient group with left subclavian artery revascularization, then we can see the perioperative mortality and morbidities are higher in the patient

who do not need a revascularization. We subgroup of these patient into Pre- and Post-TEVAR revascularization, as you can see. In a Post-TEVAR left subclavian revascularization group, perioperative mortality and major complications are higher than the patient who had a revascularization before TEVAR.

In terms of open versus endovascular revascularization, endovascular group has fewer mortality rate and major complications. It's safer, but open bypass is more effective, and durable in restoring original profusion. In summary, TEVAR with required left subclavian artery

revascularization is associated with higher rates of perioperative mortality and morbidities. Routine revascularization may not be necessary, however, the risks of left subclavian artery coverage must be carefully evaluated before surgery.

Those risk factors are CABG using LIMA. Left arm AV fistula, AV graft for hemodialysis. Dominant left vertebral artery. Occluded right vertebral artery. Significant bilateral carotid stenosis.

Greater than 20% of thoracic aorta is going to be or has been covered. And a history of open or endovascular aneurysm repair. And internal iliac artery occlusion or it's going to be embolized during the procedure. If a patient with those risk factors,

and then we recommend to have a left subclavian artery revascularization, and it should be performed before TEVAR with lower complications. Thank you very much.

- Thanks, Germano. Thanks, Gustavo. These are my disclosures as it pertains to this talk. I will be talking about the devices not yet FDA approved in the U.S. for use. We know that with endovascular repair, we need to consider all the aspects

and how we can potentially get this therapy into more people's hands. So, the Gore Company really talked to many of the key opinion leaders about the steps in doing these types of cases, how to make them simple,

they talked about anatomic screening and case planning needs to be thoughtful and careful. We emphasized with them the need to have minimized aortic coverage to limit spinal cord ischemic risk and also to talk about real world applicability

and make sure the device can be used in a wide variety of patients and not in a limited subset. If you look at the other device that has extensive use with off-the-shelf thoracoabdominal repairs, it really involves the t-Branch.

In this case, the device generally requires coverage up through 11 centimeters above the celiac artery. Marcella Ferrara has described ways to limit that with modification of the device but this is it in its current stage. With that, W.L. Gore really came up with a device

that shortened that length. It generally requires about six and a half centimeters of coverage above the celiac artery. It has been designed to work with their balloon-expandable VIABAHN device. You see on the right there,

the device has four preloaded hypo-tubes. That allows for passing four wires in to pre-catheterize each of the branches. That wire system is then brought out through a subclavian access, either right or left, through a DrySeal sheath

that then allows the implantation device in the deployment. The sequential deployment is done with the device being partially open. The portals are then catheterized from above, as you see on the far left,

and the wires placed in that. Once those have been successfully done, the branch stints are placed and then eventually the distal device is deployed and then the distal completion with the bifurcated and iliac components as necessary.

Now the technical aspects of this has been presented at this meeting and has recently been submitted and accepted for publication in JVS. Dr. Oderich is the lead author on this and really comprises the initial 13 implants with the 30-day outcomes.

Now those outcomes really focus on two things, you see the mean procedure time can vary quite a bit. That really depends upon some of the aspects about use of different axillary catheters and thoraco sheaths to get it done. But the other main thing was the blood loss

which can exceed, in a few cases, quite a bit. And that, in this trial, was mainly because they used the 12 French Flexible Cook Ansel Sheath and not the DrySeal. Once we moved to the DrySeal sheath, we see that the number of amount of blood loss

through the central port is a lot less and that's going to limit that in the future trial. Now, currently there have been 16 worldwide implants and this comprises the entire cohort that's been done. You see that early on, we only had access to the retrograde and about a third of the patients

had retrograde renal portals but since that time, mid Spring of 2016, we moved to an anterograde version alone. Most cases are type four thoracos that were done in this initial experience. What about the short-term outcomes?

Well the short-term outcomes are about 18 months. Overall survival 92 percent. One patient presented four months with multi-system failure from three vessels being occluded. The right renal had already been occluded at the time of the initial implant.

Serious adverse events. About 46 percent of patients, which is very typical, acute kidney injury and only 23 percent, and no type one or three endoleaks. There have been seven branch vessel occlusions, four in that one patient that presented acutely,

one patient a year and a half with renal artery occlusions from severe dehydration and one unilateral renal artery occulusion at approximately six months. That was managed with lysis and stenting. No difference in occlusion rates

between anterograde and retrograde. So in conclusion, the TAMBE device has completed its feasibility study with similar results for complete endovascular repair of thoracoabdominal aneurisms. Longer follow-up and a Pivotal study are planned

in pursuit of FDA approval. Thank you.

- Thank you very much, Gustavo, you read the abstract so now my task is to convince you that this very counter-intuitive technique actually works, you are familiar with Petticoat, cover stent to close a proximal entry tear and then uncover stents, bear stents, downstream. This what it would look like when we open up

the bare stent, you know dissect the aorta. So here's a case example, acute type B with malperfusion, the true lumen is sickle shaped, virtually occluded. So we use Petticoat, and we end up with a nice reopening of the true lumen, it is tagged here in green, however if you look more closely you see that here

wrapping around the true lumen there is a perfused false lumen. This is not an exception, not a complication, this is what happens in most cases, because there are always reentries in the celiac portion of the aorta.

So the Stablise concept was introduced by Australian group of Nixon, Peter Mossop in 2012, after you do the Petticoat, you are going to voluntarily balloon inside both the stent graft and the bare stents in order to disrupt, to fracture the lamel, obtain a single-channeled aorta.

This is what it looks like at TEE, after deployment of the stent graft, you see the stent graft does not open up completely, there is still some false lumen here, but after the ballooning, it is completely open. So the results were immediately very, very good, however technique did not gain a lot of consensus,

mainly because people were afraid of rupturing the aorta, they dissect the aorta. So here's a Stabilise case, once again, acute setting, malperfusion, we do a carotid subclavian bypass because we are going to cover the subclavian artery, we deploy

the cover stent graft, then with one stent overlap, we deploy two bare stent devices all the way down to the iliacs and then we start ballooning from the second stent down, so you see Coda balloon is used here, but only inside the cover stent with fabric.

And then more distally we are using a valvuloplastic balloon, which is noncompliant, and decides to be not larger than the aorta. So, I need probably to go here, this is the final result, you can see from the cross-sections that the dissection is completely gone and

the aorta is practically healed. So you might need also to address reentries at the iliac levels, attention if you have vessels that only come from the false lumen, we want to protect them during the ballooning, so we have a sheath inside this target vessel, and we are

going to use a stent afterwards to avoid fragments of the intima to get into the ostium of the artery. And this is a one-year control, so as you can see there is a complete remodeling of the aorta, the aorta is no longer dissected, it's a single channel vessel, here we can see stents in two vessels that came

from the false lumen, so very satisfactory. Once again, please remember, we use compliant latex balloons only inside the the cover stent graft, and in the bare stents we use non-compliant balloons. We have published our first cases, you can find more details in the journal paper, so in conclusion,

dear colleagues, Stabilise does work, however we do need to collect high-quality data and the international registry is the way to do this, we have the Stabilise registry which is approved by our ethical committee, we have this group of initial friends that are participating,

however this registry is physician initiated, it's on a voluntary base, it is not supported by industry, so we need all the possible help in order to get patients as quickly as possible, please join, just contact us at this email, we'd be more than happy to include everybody who is

doing this technique according to this protocol, in order to have hard data as soon as possible, thank you very much for your attention.

- Thank you for the opportunity to present this arch device. This is a two module arch device. The main model comes from the innominated to the descending thoracic aorta and has a large fenestration for the ascending model that is fixed with hooks and three centimeters overlapping with the main one.

The beginning fenestration for the left carotid artery was projected but was abandoned for technical issue. The delivery system is precurved, preshaped and this allows an easy positioning of the graft that runs on a through-and-through wire from the

brachial to the femoral axis and you see here how the graft, the main model is deployed with the blood that supported the supraortic vessels. The ascending model is deployed after under rapid pacing.

And this is the compilation angiogram. This is a case from our experience is 6.6 centimeters arch and descending aneurysm. This is the planning we had with the Gore Tag. at the bottom of the implantation and these are the measures.

The plan was a two-stage procedure. First the hemiarch the branching, and then the endovascular procedure. Here the main measure for the graph, the BCT origin, 21 millimeters, the BCT bifurcation, 20 millimeters,

length, 30 millimeters, and the distal landing zone was 35 millimeters. And these are the measures that we choose, because this is supposed to be an off-the-shelf device. Then the measure for the ascending, distal ascending, 35 millimeters,

proximal ascending, 36, length of the outer curve of 9 centimeters, on the inner curve of 5 centimeters, and the ascending model is precurved and we choose a length between the two I cited before. This is the implantation of the graft you see,

the graft in the BCT. Here, the angiography to visualize the bifurcation of the BCT, and the release of the first part of the graft in the BCT. Then the angiography to check the position. And the release of the graft by pushing the graft

to well open the fenestration for the ascending and the ascending model that is released under cardiac pacing. After the orientation of the beat marker. And finally, a kissing angioplasty and this is the completion and geography.

Generally we perform a percutaneous access at auxiliary level and we close it with a progolide checking the closure with sheet that comes from the groin to verify the good occlusion of the auxiliary artery. And this is the completion, the CT post-operative.

Okay. Seven arch aneurysm patients. These are the co-morbidities. We had only one minor stroke in the only patient we treated with the fenestration for the left carotid and symptomology regressed completely.

In the global study, we had 46 implantations, 37 single branch device in the BCT, 18 in the first in men, 19 compassionate. These are the co-morbidities and indications for treatment. All the procedures were successful.

All the patients survived the procedure. 10 patients had a periscope performed to perfuse the left auxiliary artery after a carotid to subclavian bypass instead of a hemiarch, the branching. The mean follow up for 25 patients is now 12 months.

Good technical success and patency. We had two cases of aneurysmal growth and nine re-interventions, mainly for type II and the leak for the LSA and from gutters. The capilomiar shows a survival of 88% at three years.

There were three non-disabling stroke and one major stroke during follow up, and three patients died for unrelated reasons. The re-intervention were mainly due to endo leak, so the first experience was quite good in our experience and thanks a lot.

- Thank you, thank you Frank for inviting me, again. The ascending aorta, as you know, is still the holy grail of endovascular aortic therapy. Especially, when dealing with true aortic aneurysms. There are a lot of contraindications to ascending stenting as we have listed here. So, these are all good cases for aortic surgery.

On the other hand there isn't a reason to treat some of these patients as partially high-risk patients with Endo. What about the technique? Transvalvular manipulation is essential. You basically have to do what cardiologists

are doing when they perform a TAVI procedure. And you have to know how to get across the aortic valve. There are straight forward cases like pseudo aneurysms as you can see here, which you can treat with coronary angioplasty and subsequent stenting. But the problem

or the real challenge are true ascending aneurysms. So, there are two options, bending of the ascending aorta in order to create a proximal landing zone or bending of all the ascending aorta. What about the technical details? Of course, a mediastinotomy is required.

You can use a mediastinotomy and we prefer a polypropylene mesh, which you see here. Which is additionally covered with a PTFE wrap. Just in case a recent otomy is required to prevent adhesions between the posterior

surface of the sternum and the ascending aorta. This creates downsizing of the aorta and facilitates endo-grafting here. Here typical example, the usual configuration of the true ascending aortic aneurysm wrapping with polypropylene mesh is what you get.

So, here you have your landing zone for the stent graft. When you dissect you have to circumferentially dissect the aorta. You have to make sure that you don't get into too close contact with the pulmonary artery. Here again, mediastinotomy in most cases,

is sufficient to do the procedure. Diameter reduction can be calculated according to this formula then I do know the length of my graft. You can combine this with supraoptic de-branching or bypass procedures whatever is

necessary in order to deal with this. In a lot of these cases get a landing zone for complete endo-treatment of the aortic arch with Sandwich grafts or similar techniques. We do know from these bio-mechanical studies that wrapping of the aorta reduces shear stress.

The whole concept only works in an ascending aorta up to a diameter of 6.5 cm, but no more. Here typical example, downsizing all the proximal landing zone. Subsequently, what you do get in some of these cases is in falling through here a stent graft makes sense

and then you can treat these patients with a stent graft. You would use a chimney in order to avoid compromising the origin of the innominate artery. Again, a typical example. The question is why do I have to use a stent graft at all after wrapping.

The answer is because you want to get a smooth inner surface and you don't want to have thrombus inflammation where the wrapping causes in-folding, but in all these cases you get very good results. Durable result, in term of the mediastinotomy. The mediastinotomy is very well tolerated

by these high risk patients. When you look at the age of these patients we have no neurological complications. No severe adverse events. This is a procedure, which can be offered to high risk patients

who have a lot of contraindications for open aortic surgery. Of course, this will be the future but not until maybe in ten years from now. Thank you very much.

- So, a little more on this theme that we've been talking about the last couple days, of inflow in the post-thrombotic limb. So, the key to maintaining an iliac-vein stent is good inflow and the key vessel seems to be the profunda, as we've been hearing for the last couple of days. This is the anatomy, the three axial vessels in the thigh,

the saphenous plays a very small role in venous return. We're dependent more on the femoral vein and the profunda. And the femoral vein just seems to be more prone to thrombosis and problems, and the profunda's there to salvage. We like to see good axial transformation of the profunda.

If we see this, you can get an IVUS catheter in these vessels from above usually. You can feel pretty confident the inflow's satisfactory. There's been some enthusiasm now to try and improve inflow, as we've been hearing, by interventions on the femoral vein. And you saw this paper earlier,

where these people had iliac-vein stents, and they we're trying to improve inflow either with femoral-vein stenting or femoral-vein angioplasty alone. And very, very high failure rates. All of them were occluded by a year, in both the angioplasty and stent groups.

My experience, I've probably done a handful of femoral-vein stents. This guy been in the practice for a couple, 15 years, post-thrombotic with iliac vein stents and some reason, his PCP discontinued his Warfarin, and the stent went down. So, this is in the office center,

acutely occluded common iliac, external iliac vein stent, and the confluence. You see thrombus in the confluence and in the profunda, which was obviously, discouraging. I got them open with the AngioJet, including his profunda. So, his symptoms of swollen thigh and calf,

and the thigh markedly improved. And he comes back a couple two year later, he's a UPS worker with complaining that he feels great, but the calf's still a problem, can I do anything else. We had a whole discussion on femoral vein intervention and he wanted to give it a shot.

The femoral vein was occluded beforehand. Here's the profunda open in SFA. So, this is prone on table, we got a good popliteal, we got a good profunda. And, you know, is this going to help him at all? But, he wanted to go for it.

This is with IVUS, the femoral vein's pretty much occluded. The popliteal vein's open. And we put a nitinol stent down, and they key is to try and land above your profunda collateral so you don't jail it. So, this is one if the ones that did well.

I got a couple doing well, and the others, not so well. So, this kid, 31 years old, multiple DVTs at such a young age, in both legs. We want to do something. His common iliac was wide open, this was diseased, so we stented this,

he got a little better, not great, he comes back a year later, can you do anything else. We began the whole discussion of femoral vein intervention doesn't work well. This is on the table prone, and just a harbinger of failure, if I can't get into the popliteal vein,

have to use a gastroc, that's a telling sign. So, I went ahead and stented his femoral vein, tried to preserve the collaterals. You can't see the popliteal that well down here, but it looked decent. He showed up with his INR low and occluded,

the whole thing went down. Here's the tail end of the nitinol stent. You can see the popliteal inflow is horrible. I got him open, but you know, it just doesn't look great. So, he went down and stayed down, reoccurring ulcers, and the poor young guy can't do anything.

In this case, again, the theme is we got iliac stents in place, so we can improve inflow. So, she comes in a couple years later, with new inflow disease on duplex and new symptoms. And you think, well you know, we'll just do a little segment of the femoral vein

where there's a tight lesion, maybe it'll help her inflow. With angioplasty alone, you can see the remain pretty tight, so I went ahead and put a stent there. Looked great afterwards, I was encouraged. But one month later, that segment of femoral vein stent went down.

You've heard of, in the early days, when we were doing thoracic aortic aneurysms iliac artery on a stick, well this is a femoral vein on a stick, so be careful. Conclusion, femoral vein stenting fails often and early. Uncharted waters may be a value in selected cases,

and I also want to see the PTS-XS trial results. Thanks.

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