- Thank you very much, Dr. Veith, and thank you to you and the organizing committee for inviting me to participate again this year in, really, the premiere vascular meeting. This morning, I'd like to talk about the contemporary management of carotid artery aneurysms. These are my disclosures.
Extracranial carotid artery aneurysms and pseudoaneurysms may result from a variety of causes, including trauma, fibromuscular dysplasia, atherosclerosis. They're associated with dissection, connective tissue disorders, mycotic aneurysms associated with infection.
We see patch aneurysms from prior carotid endarterectomy, as well as aneurysms associated with radiation, and those that occur spontaneously. Sequelae of these aneurysms are often distal embolization, potential for thrombosis, some patients experience compressive symptoms, and rupture may occur as well.
Treatment has traditionally been through open surgical repair, but there have been advances in endovascular treatments, including covered stents, woven stents, such as the pipeline stent in size-appropriate cases, bare stents with or without adjunctive coil embolization.
Open surgical repair has been time tested and it's proven to be very effective, but there are potential morbidities associated with challenges or surgical exposure, particularly in patients with prior surgery or radiation and those with anatomically-challenging lesions.
A very definitive review of this has been conducted by the surgeons at the Mayo Clinic, including Drs. Money, Bower, and Fowl, and they have described the treatment of 141 aneurysms in 132 patients. In the evolution of treatment with endovascular techniques, covered stents have been employed.
These eliminate aneurysm and pseudoaneurysm perfusion completely and immediately after deployment, but there have been reports of delayed thrombosis of these covered stents when they've been deployed in the cervical distribution. This is a patient of ours who has a large patch aneurysm, nearly four centimeters in size.
If you look on the CAT scan you'll see there's very limited, essentially no overlying soft tissues as a result of the previous radical neck dissection. In this case, we'd elected to use a covered stent to achieve exclusion of this patch aneurysm, and then used a bare metal stent distally to augment the treatment itself.
Our therapies progressed to the use of bare metal stents with associated coil embolization so-called stent, assisted coil embolization. As you can see, there are two sequential, very large, pseudoaneurysms of the internal carotid artery. Here's the carotid bifurcation.
Here, I hope you can see between these green arrows, is the stent that's been deployed. We use closed cell stents typically for these applications, and we can use a microcatheter cannulate that pseudoaneurysm and deploy large neuro-embolic coils to promote flow of cessation.
When we follow up with these patients, here's this patient's one-month post-operative duplex ultrasound, there's no flow in the pseudoaneurysm, and excellent flow in the internal carotid artery without stenosis. We've then progressed to the use of overlapping closed cell stents, and in doing so,
hoped to sort of simulate the pipeline woven stent configuration but have greater applicability in terms of diameter of the internal carotid. Here, you can see this internal carotid artery spontaneous pseudoaneurysm. We then go ahead and bring our initial stent into position
across the origin of the pseudoaneurysm. Here's after initial stent deployment on this static image. Here, after our second stent deployment, you can see very limited static flow within the pseudoaneurysm itself, and that's evidenced by, after the flowed out of the internal carotid artery,
there's still residual contrast within the pseudoanerusym. Here are the individual characteristics of the patients that we've treated using endovascular techniques. To summarize those data, the mean duration of follow up for these patients is 331 days.
But we have followed one patient out to eight years. The study's limited by the relatively small number of patients and the limited duration of follow up in these patients. But our technical success has been 100%, in terms of being able to deploy the endovascular
techniques, and maintain patency. We've had no patients who've experienced neurologic sequelae, including no strokes or TIAs. There've been no cases in which the aneurysm has expanded, in most cases, the aneurysm itself regresses and there's been no flow within those aneurysms or pseudoaneurysms.
Finally, we have been able to maintain 100% patency in these patients, as monitored using our standard follow up protocol with duplex ultrasound being performed every three months for the first year, and annually thereafter. In conclusion, extracranial carotid artery aneurysms and pseudoaneurysms may be treated effectively
using standard open techniques. However, surgical exposure and perioperative morbidity may present challenges for open repair. Endovascular approaches to aneurysm and pseudoaneurysm treatment have evolved progressively. The preliminary results of our analysis with mid-term
follow up suggest that these techniques are effective and durable, with limited procedural morbidity. Thank you very much.
- Well, thank you Andrej, I will present you the minimal invasive segmental artery coil embolization for prevention of spinal cord ischemia during EVAR of thoracoabdominal aortic pathologies, our initial clinical results. As all, I have nothing to disclose related to this presented topic.
As all we know ischemic spinal cord injury has a high incidence up to 20% after open or endovascular repair of thoracoabdominal aortic aneurysm and this is despite conventional perioperative neuroprotective strategies such as blood pressure management or continuous CSF drainage and also despite staged aortic repair such as
staged endovascular repair or temporary aneurysm sac perfusion. That's why our opinion is that, we have to have a pragmatic approach for prevention of spinal cord ischemia. First, our opinion is that you've to revascularize as many inflow arteries as possible such as
subclavian or hypogastric artery. You've to optimize your hemodynamic management perioperatively and last but not the least, we think that you've to improve your strategies that induce development of collateral arteries, that means, you have to ischemic precondition the spinal cord.
The ischemic preconditioning of the spinal cord is based on the collateral network concept of the spinal cord perfusion and that means that the hypothesis of spinal blood supply depending mainly on the critical arterial input of the Adamkiewicz artery is obsolete. As you can see here, of some of our intraoperative images
that blood supply of the spinal cord is guaranteed by two nal and intraspinal compartment And from this compartment, there are very small arteries, you can see here on this image. The anterior radiculomedullary artery, that gives further
supply to the main spinal cord artery, the anterior spinal artery. So, based on this concept, we developed ischemic preconditioning and that means that we occlude the main stem of several segmental arteries in order to preserve the capability of
paraspinous collateral network to build new arteries and we do that by minimal invasive staged occlusion of the segmental artery and basically this is an entirely endovascular first stage of a staged approach for thoracoabdominal aortic repair to reduce the ischemic injury of the spinal cord.
The procedure performed local anesthesia with a percutaneous trans-femoral access with a small bore sheath, the patient is awake, there has no cerebrospinal fluid drainage and we perform the clinical monitoring of the patient for at least 48 hours after the procedure. I won't go in details about the procedure, Andrej will let
you guide you through, I will show you our data. You can see, here between September 2014 and December 2017 we've treated 57 patients with MISACE in our institution. You can see here the characteristic of the patient. 75% were male with mean age of 69.6 years of age all over they were hypertension, and most of them, 39, had a
extensive Crawford type II and type III aortic aneurysm. The mean aortic diameter was 62.7. Some of them, they had previous repair of the aorta and 94% were atherosclerotic in all age. So, how do we perform the procedure? So, we look, we've, we look at our CT scan of the patient
and we know from the pre-planning where the aorta will be covered. And in this area, we look at the segmental arteries and we count the segmental arteries, we don't only count, also mark the segmental arteries that will be covered by the stent grafts.
And, you can see here in median we had nine open segmental arteries of this area ranging from 2 up to 26. Then we start the coiling procedure and you can see here that 38.6% of patient had only one coiling session, 42.1% had 2 session of Minimally invasive coil embolization and 19.3% of the patient had more than two stage coil.
And you can see here that, between those two coiling sessions, we had mean interval of 60 days. And you can see here that we have performed maximum five sessions per patient and during those sessions we've coiled maximum six segmental arteries and per patient we've coiled up to 19 segmental arteries
and median was number of 5. You can see here distribution of the segmental arteries after MISACE at the level of the planned aortic coverage. With blue, sorry with dark, it's the, they're segmental arteries were already occluded, with grey it's segmental arteries that we've already coiled
and with red is segmental arteries that we've not coiled. Again this is the first initial clinical experience and at the end of the entire coiling procedure, we've occluded median 77.7% of the entire segmental arteries of that level. You can see here the characteristic of the
coiling of session. You can see here that basically between the first and second sessions, they're not too many differences, the third session is quiet quicker and we've no spinal cord ischemia after this coiling sessions and we've some minor complication like quarter of our patient developed
backpain which resolved with NSAIDs, we had lost two coils, we were able to recover and we were unable to occlude one segmental artery in three patients. After seven days but no sooner than that, in order to let the collaterals of spinal cord to develop, we performed the complete aneurysm exclusion of these patients.
You can see here, 55 of our patient were completely excluded in the mean time of 83 days. To mention that, two patients died waiting for the CMD graft due to the cardiac problems not related to the aneurysm pathology. You can see here the characteristic of the TEVAR procedure.
You can see here we performed, all type of stent grafts from tube stent-graft to fenestration branch combined stent graft. In one patient, we've the subclavian coverage on the left side and in 80% of the patients the hypogastric are true or patent.
To mention that, the length of the covered aorta in our cohort was 270 mm. After the complete repair of the thoracoabdominal aortic aneurysm, at 30 days, you can see our result, we've no spinal cord ischemia in this patient, one patient died due to related aneurysm problem.
And by looking at this data, we conclude that the first experience suggest that the minimal invasive segmental artery coil embolization is feasible, safe and in our opinion, effective but can be challenging and it's a new field with a many open questions. And we think that the ultimate proof of this technology
of this procedure requires randomized trial which is currently underway, this PAPA-ARTiS trial, paraplegia prevention in aortic aneurysm repair by thoracoabdominal staging with MISACE. Thank you for your attention.
- Lymphatic, so it's fun, actually, not to talk on venous interventions for once. And, naturally, the two systems are very different. But, on the other hand, they're also related in several ways and I will come back to that later. I have no disclosures, maybe only my gratitude to this man, Dr. Maxim Itkin,
who actually got me started in the field, and was gracious enough to supply me some of his material. And who is also responsible for making our lives way easier over the last years. Because in former times, we needed to do, to visualize the lymphatic system,
we needed to do pedal lymphangiography and that was very, very cumbersome. It took a long time and was very painful for the patient. And he introduced the ultrasound guided intranodal lymphangiography,
and that's fairly easy for most of us. With ultrasound you find a lymph node in the groin, you puncture that and you can control the needle position with contrast enhanced ultrasound and once you establish that position, you might do a MR lymphangiography.
Thereby showing, in this case, a beautiful, normal anatomy of the thoracic duct. I need to say, the variations in lymphatics are extreme. So, you can also visualize, naturally, the pathology, like for example, pulmonary lymphatic perfusion syndrome.
What's going on there. Normally, lymph courses up through thoracic duct, but in this case, you kind of have a reflux in the bronchial tree and lymph leakage. And you can image that again, beautifully with MR, which you can show extensive leakage
of lymph in the lung parenchyma. So you can treat that. How can you treat that? By embolization of the thoracic duct. But first we need to get into there, and that's not a very easy thing to do.
But now, again, with access to a lymph node in the groin, you can push lipiodol, and then visualize the cisterna chyli and access that transcutaneously with a 21/22 gauge needle and then push up a O-18 wire high up in the thoracic duct.
First you deploy some coils to prevent any leakage of glue inside the venous system, and then by microcatheter, you infuse glue all the way down, embolizing the thoracic duct. So, complete different group of lymphatic disorders is oriented in the liver and hepatic lymphatic disorders.
And maybe not everybody knows that, but 80% of the flow in the thoracic duct is caused by the liver and by the intestine. And many times in lymphatic disorders, there needs to be a combination of two factors. One factor is a venous variation of a,
sorry, an anatomical variation in lymph vessels and the other one is that we have an increase in lymph flow. And in the liver, that can be caused by a congestion of the liver, for example, cirrhosis, or a right side, that's congested heart failure.
What happens then is you increase the flow, the lymph flow, tremendously and if you also have a variation like in this case, when the vessels do not directly course towards the cisterna chyli, but in very close contact to the abdomen,
then you can have leakage of the lymph and leakage of proteins, which is a serious problem. So, what is then, to do next? You can access the lymph vessels in the liver by percutaneous access in the periportal space,
and induce some contrast and then later, visualize that one back, visualize that with dye that you can see with an endoscopy, thereby proving your diagnosis, and then, in a similar way,
you can induce lipiodol again with glue, embolizing the lymph vessels in the liver, treating the problem. In summary, popularity of lymphatic interventions really increased over the last years mainly because novel imaging,
novel interventional techniques, new approaches, and we all gained more experience. If you would like, I would guess that, we are at a phase where we were at venous, like 10, 15 years ago. If we are a little bit positive,
then the future is very bright. And within 10, 15 years, we find new indications and probably have much more to tell you. Thank you for your attention.
- [Doctor] Thank you Tom and thanks Dr Veith for the invitation to be here again. These are my disclosures, so hypogastric embolization is not benign, patients can develop buttock claudication, higher after bilateral sacrifice, it can be persistent in up to half of patients. Sexual dysfunction can also occur, and we know that
there can be catastrophic complications but fortunately they're relatively rare. So now these are avoidable, we no longer have to coil and cover in many patients and we can preserve internal iliac's with iliac branch devices like you just heard. We had previously published the results of looking from
the pivotal trial, looking at the Gore IBE device with the six month primary end point showing zero aneurysm-related morality, high rates of technical success, 95% patency of the internal iliac limb, no type one or type three endoleaks and 98% freedom from reintervention. Importantly on the side of the iliac branch device, there
was prevention of new-onset of buttock claudication in all patients, and importantly also on the contralateral side in patients with bilateral aneurysms that were sacrificed, the incidents in a prospect of trial of the development of buttock claudication was 28%, confirming the data from those prior series.
And this is in line with the results of EVAR using iliac branch device published by many others showing low rates of mortality, high rates of technical success and also good patency of the devices. In press now we have results with follow-up out through two years, in the Gore IBE trial, we also compared
those findings to outcomes in a real world experience from the great registry, so 98 patients from the pivotal and continued access arm's of the IBE trial and also 92 patients who underwent treatment with the Gore IBE device in the great registry giving us 190 patients with 207 IBE devices implanted.
Follow-up was up to three years, it was an longer mean follow-up in the IDE study with the IBE device. Looking at outcomes between the clinical trial and the real world experience, they were very similar. There was no aneurysm-related mortality, there was no recorded new-onset ipsilateral buttock claudication,
this is all from the IDE trial since we didn't have that information in the great registry, and looking at the incidence of reinterventions, it was similar both in the IDE clinical trial experience and also in the great registry as well. Looking at patency of the internal iliac limb, it was
93.6%, both at 12 months and 24 months in the prospective US IBE pivotall trial and importantly all the internal iliac limb occlusions occurred very early in the experience likely due to technical or anatomic factors. When we look at the incidence of type two endoleaks, we had previously noted there was a very high incidence of
type two endoleaks, 60% at one month, this did tail off a bit over time but it was still 35% at two years. A total of five patients in the pivotal IBE trial had a reintervention for type two endoleak through two years, and despite that high incidence of type two endoleak, overall the incidence of aortic aneurysm sac expansion
of more than five millimeters has been rare and low at two and nine percent at 12 and 24 months, and there's been no expansions of the treated common iliac artery aneurysm sac's at either 12 or 24 months. Freedom from reintervention has been quite good, 90.4% through two years in the trial and most of these
re-interventions were type two endoleaks. We now have some additional data out through three years in about two thirds of the patients we have imaging data available now through three years in the pivotal IBE trial, there have been no additional events, device related events reported since the two year data and through three years
we have no recorded type one or type three endoleaks, no aneurysm ruptures, no incidences of migration, very high rates of patency of the external and internal iliac arteries, good freedom from re-intervention and good freedom from common iliac artery aneurysm sac enlargement. And I think, in line with these findings, the guidelines
now from the SVS are to recommend preservation of the internal iliac arteries when ever present and that's a grade 1A recommendation, thank you.
- Relevant disclosures are shown in this slide. So when we treat patients with Multi-Segment Disease, the more segments that are involved, the more complex the outcomes that we should expect, with regards to the patient comorbidities and the complexity of the operation. And this is made even more complex
when we add aortic dissection to the patient population. We know that a large proportion of patients who undergo Thoracic Endovascular Aortic Repair, require planned coverage of the left subclavian artery. And this also been demonstrated that it's an increase risk for stroke, spinal cord ischemia and other complications.
What are the options when we have to cover the left subclavian artery? Well we can just cover the artery, we no that. That's commonly performed in emergency situations. The current standard is to bypass or transpose the artery. Or provide a totally endovascular revascularization option
with some off-label use , such as In Situ or In Vitro Fenestration, Parallel Grafting or hopefully soon we will see and will have available branched graft devices. These devices are currently investigational and the focus today's talk will be this one,
the Valiant Mona Lisa Stent Graft System. Currently the main body device is available in diameters between thirty and forty-six millimeters and they are all fifteen centimeters long. The device is designed with flexible cuff, which mimics what we call the "volcano" on the main body.
It's a pivotal connection. And it's a two wire pre-loaded system with a main system wire and a wire through the left subclavian artery branch. And this has predominately been delivered with a through and through wire of
that left subclavian branch. The system is based on the valiant device with tip capture. The left subclavian artery branch is also unique to this system. It's a nitinol helical stent, with polyester fabric. It has a proximal flare,
which allows fixation in that volcano cone. Comes in three diameters and they're all the same length, forty millimeters, with a fifteen french profile. The delivery system, which is delivered from the groin, same access point as the main body device. We did complete the early feasibility study
with nine subjects at three sites. The goals were to validate the procedure, assess safety, and collect imaging data. We did publish that a couple of years ago. Here's a case demonstration. This was a sixty-nine year old female
with a descending thoracic aneurysm at five and a half centimeters. The patient's anatomy met the criteria. We selected a thirty-four millimeter diameter device, with a twelve millimeter branch. And we chose to extend this repair down to the celiac artery
in this patient. The pre-operative CT scan looks like this. The aneurysm looks bigger with thrombus in it of course, but that was the device we got around the corner of that arch to get our seal. Access is obtained both from the groin
and from the arm as is common with many TEVAR procedures. Here we have the device up in the aorta. There's our access from the arm. We had a separate puncture for a "pigtail". Once the device is in position, we "snare" the wire, we confirm that we don't have
any "wire wrap". You can see we went into a areal position to doubly confirm that. And then the device is expanded, and as it's on sheath, it does creep forward a bit. And we have capture with that through and through wire
and tension on that through and through wire, while we expand the rest of the device. And you can see that the volcano is aligned right underneath the left subclavian artery. There's markers there where there's two rings, the outer and the inner ring of that volcano.
Once the device is deployed with that through and through wire access, we deliver the branch into the left subclavian artery. This is a slow deployment, so that we align the flair within the volcano and that volcano is flexible. In some patients, it sort of sits right at the level of
the aorta, like you see in this patient. Sometimes it protrudes. It doesn't really matter, as long as the two things are mated together. There is some flexibility built in the system. In this particular patient,
we had a little leak, so we were able to balloon this as we would any others. For a TEVAR, we just balloon both devices at the same time. Completion Angiogram shown here and we had an excellent result with this patient at six months and at a year the aneurysm continued
to re-sorb. In that series, we had successful delivery and deployment of all the devices. The duration of the procedure has improved with time. Several of these patients required an extension. We are in the feasibility phase.
We've added additional centers and we continue to enroll patients. And one of the things that we've learned is that details about the association between branches and the disease are critical. And patient selection is critical.
And we will continue to complete enrollment for the feasibility and hopefully we will see the pivotal studies start soon. Thank you very much
- Thank you. Historically, common femoral endarterectomy is a safe procedure. In this quick publication that we did several years ago, showed a 1.5% 30 day mortality rate. Morbidity included 6.3% superficial surgical site infection.
Other major morbidity was pretty low. High-risk patients we identified as those that were functionally dependent, dyspnea, obesity, steroid use, and diabetes. A study from Massachusetts General Hospital their experience showed 100% technical success.
Length of stay was three days. Primary patency of five years at 91% and assisted primary patency at five years 100%. Very little perioperative morbidity and mortality. As you know, open treatment has been the standard of care
over time the goal standard for a common femoral disease, traditionally it's been thought of as a no stent zone. However, there are increased interventions of the common femoral and deep femoral arteries. This is a picture that shows inflection point there.
Why people are concerned about placing stents there. Here's a picture of atherectomy. Irritational atherectomy, the common femoral artery. Here's another image example of a rotational atherectomy, of the common femoral artery.
And here's an image of a stent there, going across the stent there. This is a case I had of potential option for stenting the common femoral artery large (mumbles) of the hematoma from the cardiologist. It was easily fixed
with a 2.5 length BioBond. Which I thought would have very little deformability. (mumbles) was so short in the area there. This is another example of a complete blow out of the common femoral artery. Something that was much better
treated with a stent that I thought over here. What's the data on the stenting of the endovascular of the common femoral arteries interventions? So, there mostly small single centers. What is the retrospective view of 40 cases?
That shows a restenosis rate of 19.5% at 12 months. Revascularization 14.1 % at 12 months. Another one by Dr. Mehta shows restenosis was observed in 20% of the patients and 10% underwent open revision. A case from Dr. Calligaro using cover stents
shows very good primary patency. We sought to use Vascular Quality Initiative to look at endovascular intervention of the common femoral artery. As you can see here, we've identified a thousand patients that have common femoral interventions, with or without,
deep femoral artery interventions. Indications were mostly for claudication. Interventions include three-quarters having angioplasty, 35% having a stent, and 20% almost having atherectomy. Overall technical success was high, a 91%.
Thirty day mortality was exactly the same as in this clip data for open repair 1.6%. Complications were mostly access site hematoma with a low amount distal embolization had previously reported. Single center was up to 4%.
Overall, our freedom for patency or loss or death was 83% at one year. Predicted mostly by tissue loss and case urgency. Re-intervention free survival was 85% at one year, which does notably include stent as independent risk factor for this.
Amputation free survival was 93% at one year, which factors here, but also stent was predictive of amputation. Overall, we concluded that patency is lower than historical common femoral interventions. Mortality was pretty much exactly the same
that has been reported previously. And long term analysis is needed to access durability. There's also a study from France looking at randomizing stenting versus open repair of the common femoral artery. And who needs to get through it quickly?
More or less it showed no difference in outcomes. No different in AVIs. Higher morbidity in the open group most (mumbles) superficial surgical wound infections and (mumbles). The one thing that has hit in the text of the article
a group of mostly (mumbles) was one patient had a major amputation despite having a patent common femoral artery stent. There's no real follow up this, no details of this, I would just caution of both this and VQI paper showing increased risk amputation with stenting.
- So Beyond Vascular procedures, I guess we've conquered all the vascular procedures, now we're going to conquer the world, so let me take a little bit of time to say that these are my conflicts, while doing that, I think it's important that we encourage people to access the hybrid rooms,
It's much more important that the tar-verse done in the Hybrid Room, rather than moving on to the CAT labs, so we have some idea basically of what's going on. That certainly compresses the Hybrid Room availability, but you can't argue for more resources
if the Hybrid Room is running half-empty for example, the only way you get it is by opening this up and so things like laser lead extractions or tar-verse are predominantly still done basically in our hybrid rooms, and we try to make access for them. I don't need to go through this,
you've now think that Doctor Shirttail made a convincing argument for 3D imaging and 3D acquisition. I think the fundamental next revolution in surgery, Every subspecialty is the availability of 3D imaging in the operating room.
We have lead the way in that in vascular surgery, but you think how this could revolutionize urology, general surgery, neurosurgery, and so I think it's very important that we battle for imaging control. Don't give your administration the idea that
you're going to settle for a C-arm, that's the beginning of the end if you do that, this okay to augment use C-arms to augment your practice, but if you're a finishing fellow, you make sure you go to a place that's going to give you access to full hybrid room,
otherwise, you are the subservient imagers compared to radiologists and cardiologists. We need that access to this high quality room. And the new buzzword you're going to hear about is Multi Modality Imaging Suites, this combination of imaging suites that are
being put together, top left deserves with MR, we think MR is the cardiovascular imaging modality of the future, there's a whole group at NIH working at MR Guided Interventions which we're interested in, and the bottom right is the CT-scan in a hybrid op
in a hybrid room, this is actually from MD Anderson. And I think this is actually the Trauma Room of the future, makes no sense to me to take a patient from an emergency room to a CT scanner to an and-jure suite to an operator it's the most dangerous thing we do
with a trauma patient and I think this is actually a position statement from the Trauma Society we're involved in, talk about how important it is to co-localize this imaging, and I think the trauma room of the future is going to be an and-jure suite
down with a CT scanner built into it, and you need to be flexible. Now, the Empire Strikes Back in terms of cloud-based fusion in that Siemans actually just released a portable C-arm that does cone-beam CT. C-arm's basically a rapidly improving,
and I think a lot of these things are going to be available to you at reduced cost. So let me move on and basically just show a couple of examples. What you learn are techniques, then what you do is look for applications to apply this, and so we've been doing
translumbar embolization using fusion and imaging guidance, and this is a case of one of my partners, he'd done an ascending repair, and the patient came back three weeks later and said he had sudden-onset chest pain and the CT-scan showed that there was a
sutured line dehiscence which is a little alarming. I tried to embolize that endovascular, could not get to that tiny little orifice, and so we decided to watch it, it got worse, and bigger, over the course of a week, so clearly we had to go ahead and basically and fix this,
and we opted to use this, using a new guidance system and going directly parasternal. You can do fusion of blood vessels or bones, you can do it off anything you can see on flu-roid, here we actually fused off the sternal wires and this allows you to see if there's
respiratory motion, you can measure in the workstation the depth really to the target was almost four and a half centimeters straight back from the second sternal wire and that allowed us really using this image guidance system when you set up what's called the bullseye view,
you look straight down the barrel of a needle, and then the laser turns on and the undersurface of the hybrid room shows you where to stick the needle. This is something that we'd refined from doing localization of lung nodules
and I'll show you that next. And so this is the system using the C-star, we use the breast, and the localization needle, and we can actually basically advance that straight into that cavity, and you can see once you get in it,
we confirmed it by injecting into it, you can see the pseudo-aneurism, you can see the immediate stain of hematoma and then we simply embolize that directly. This is probably safer than going endovascular because that little neck protects about
the embolization from actually taking place, and you can see what the complete snan-ja-gram actually looked like, we had a pig tail in the aura so we could co-linearly check what was going on and we used docto-gramming make sure we don't have embolization.
This patient now basically about three months follow-up and this is a nice way to completely dissolve by avoiding really doing this. Let me give you another example, this actually one came from our transplant surgeon he wanted to put in a vas,
he said this patient is really sick, so well, by definition they're usually pretty sick, they say we need to make a small incision and target this and so what we did was we scanned the vas, that's the hardware device you're looking at here. These have to be
oriented with the inlet nozzle looking directly into the orifice of the mitro wall, and so we scanned the heart with, what you see is what you get with these devices, they're not deformed, we take a cell phone and implant it in your chest,
still going to look like a cell phone. And so what we did, image fusion was then used with two completely different data sets, it mimicking the procedure, and we lined this up basically with a mitro valve, we then used that same imaging guidance system
I was showing you, made a little incision really doing onto the apex of the heart, and to the eur-aph for the return cannula, and this is basically what it looked like, and you can actually check the efficacy of this by scanning the patient post operatively
and see whether or not you executed on this basically the same way, and so this was all basically developed basing off Lung Nodule Localization Techniques with that we've kind of fairly extensively published, use with men can base one of our thoracic surgeons
so I'd encourage you to look at other opportunities by which you can help other specialties, 'cause I think this 3D imaging is going to transform what our capabilities actually are. Thank you very much indeed for your attention.
- Thank you, chairman. Good afternoon, ladies and gentlemen. I've not this conflict of interest on this topic. So, discussion about double-layer stent has been mainly focused about the incidence of new lesions, chemical lesions after the stenting, and because there are still some issue
about the plaque prolapse, this has still has been reduced in a comparison to conventional stent that's still present. We started our study two years ago to evaluate on two different set of population of a patient who underwent stent, stenting,
to see if there is any different between the result of two stents, Cguard from Inspire, and Roadsaver from Terumo in term of ischemic lesion and if there is a relationship between the activity of the plaque evaluated with the MRI
and new ischemic lesion after the procedure. So, the population was aware of similar what we found, and that there's no difference between the two stent we have had, and new ischemic lesions is, there's a 38%, for a total amount of 34 lesions,
and ipsilateral in 82% of cases. The most part of the lesion appeared at the 24 hours, for the 88.2% of cases, while only the 12% of cases, we have a control at our lesion. According to the DWI, we have seen that
the DWI of the plaque is positive, or there is an activity of the plaque. There's a higher risk of embolization with a high likelihood or a risk of 6.25%. But, in the end, what we learned in the beginning, what there have known,
there's no difference in the treatment of the carotid stenosis with this device, and the plaque activity, when positive at the DWI MR, is a predictive for a higher risk of new ischemic lesions at 24 hours. But, what we are still missing in terms of information,
where something about the patency of the stents at mid-term follow-up, and the destiny of external carotid artery at mid-term follow-up. Alright, we have to say we have an occlusion transitory, occlusion of the semi-carotid artery
immediately after the deployment of the Terumo stent. The ECA recovery completely. But in, what we want to check, what could happen, following the patient in the next year. So, we perform a duplicate ultrasound, at six, at 12, and 24 months after the procedure,
in order to re-evaluate the in-stent restenosis and then, if there was a new external carotid artery stenosis or occlusion. We have made this evaluation according to the criteria of grading of carotid in-stent restenosis proposed on Stroke by professors attache group.
And what we found that we are an incidence of in-stent restenosis of 10%, of five on 50 patient, one at six month and four at one year. And we are 4% of external carotid artery new stenosis. All in two patient, only in the Roadsaver group.
We are three in-stent restenosis for Roadsaver, two in-stent restenosis for Cguard, and external new stenosis only in the Roadsaver group. And this is a case of Roadsaver stent in-stent restenosis of 60% at one year. Two year follow-up,
so we compare what's happening for Cguard and Roadsaver. We see that no relation have been found with the plaque activity or the device. If we check our result, even if this is a small series, we both reported in the literature for the conventional stent,
we've seen that in our personal series, with the 10% of in-stent restenosis, that it's consistent with what's reported for conventional CAS. And the same we found when we compared our result with the result reported for CAS with conventional stent.
So in our personal series, we had not external carotid artery occlusion. We have 4% instance, and for stenosis while with conventional CAS, occlusion of external carotid artery appear in 3.8% of cases.
So, what can we add to our experience now in the incidence, if, I'm sorry, if confirmed by larger count of patient and longer study? We can say that the incidence of in-stent restenosis for this new double-layer stent and the stenosis on the external carotid artery,
if not the different for all, with what reported for conventional stent. Thank you.
- That's a long title, thank you. We shortened the title, and just said, The Iliac Artery's Complicating Complex Juxtarenal and Thoracal Abdominal Repair. I have no disclosures. So, Iliac artery preservation is important whenever we start doing complex aortic aneurysm repair.
We don't understand completely what the incidence is with these extensive aneurysms. We know with AAAs, anywhere in the 10 to 40% have some sort of iliac artery involvement. It certainly can complicate the management as we get to these more complicated repairs.
Iliac artery preservation may be important for prevention of spinal cord ischemia, and those people in whom we can maintain both hypogastric arteries, it occurs at a less significant rate, with less severe symptoms and higher rates of recovery.
The aim of our study was to evaluate the incidence, management, and outcomes of iliac artery aneurysms associated with complex aortic aneurysms treated with fenestrated and branched endografts. Part of a PS-IDE study over a 15 year period of time,
this is dated from the Cleveland Clinic for the treatment of juxtarenal aneurysms and thoracal abdominal aortic aneurysms. For the purpose of this study, we defined an iliac artery aneurysm is 21 mm or greater as determined by diameter
by our core lab. We chose 21 mm because this was outside of the IFU for the iliac wounds that we had currently available to us at that time. We did multivariable analysis on the number of different outcomes. And we looked at the incidence
of iliac artery aneurysms by repair type. In all the aneurysms we treated, we see about a third of the patients had some level of iliac artery aneurysm involvement. In those patients that had less extensive thoracal abdominals, the type three
and type four abdominals, it occurred in about a third of the cases. A little bit less than the type two and the type one thoracal abdominals. We look at the demographics between those that had iliac artery aneurysm
involvement and those that did not have iliac artery involvement. It was more common in males to have iliac artery involvement than any other group. There are more females that didn't have iliac artery aneurysms. The rest
of the demographics were the same between the two groups. We look at the anatomic characteristics of the iliac artery aneurysms, about 60% of them were unilateral, about 40% of them were bilateral.
The mean iliac artery aneurysm size was 28 mm and that was the same on both sides. And we look at thought the percent that were actually very large, or considered large enough to potentially in and of themselves the repairs
greater than three centimeters. About 28% of them were greater than three centimeters on each side. If we look at our iliac artery aneurysm treatment type, this is 509 iliac artery aneurysms that
were treated out of all these patients. About 46% of them, we were able to obtain a seal distal to the iliac artery aneurysm. So it really only involved the proximal portion, the proximal half of the iliac artery.
20% of them, we placed a hypogastric branched endograft, and about 20% of them, we placed a hypogastric coverage plus embolization of that internal iliac artery. About 13% of them were left untreated at the time for a variety of different operative reasons.
Why is there a difference between the hypogastric coverage and embolization? It was availability of devices and surgeon choice at the time. At one point, we had a opportunity to be able to treat both fairly easily
on both sides and at one point we did not. Larger iliac artery aneurysms were treated with hypogastric coverage or hypogastric branched endografts, and there was a significant difference between the two. Most of the mean
size of those that were actually treated with either hypogastric branch or embolization for greater than three centimeters. If we look at peri-operative outcomes in those without iliac artery aneurysms versus those with iliac artery aneurysms.
We see that the fluoroscopy estimated blood loss is larger for those with iliac artery aneurysms, fluoroscopy time was longer and procedure duration was a bit longer as well. Obviously, a bit more complicated procedure,
more steps that's going to take a little bit longer to perform them. It did not effect the length of stay for these patients or the length of stay in the intensive care unit following the procedures. We look
at all-cause mortality at five years, no difference in whether they had an iliac artery aneurysm or not. It didn't matter whether it was unilateral or bilateral. If we look at aneurysm-related mortality, it's the same whether
they had the iliac artery aneurysm or not. Same for unilateral versus bilateral as well. Where we start to see some differences are the freedom from reintervention. This did vary between, among the three groups. In those patients without an iliac
artery aneurysm, they had the lower reintervention rate than those with the unilateral iliac artery aneurysm, and even lower rates from freedom from reintervention in those that had bilateral iliac artery aneurysms. Spinal cord ischemia, one of the
reasons we try to preserve both the hypogastric arteries. Look at our total spinal cord ischemia incidents. It didn't vary between the two groups, but if we look specifically, the type two thoracal abdominal aortic aneurysms in those patients that had bilateral
iliac arte higher rate of spinal cord ischemia compared to those that did not have any iliac artery aneurysms or those that had an internal iliac, a single iliac artery aneurysm.
So, iliac artery aneurysms affect about a third of the patients with complex aortic disease. They do not, their presence does not affect all-cause mortality or aneurysm related mortality. They are associated with a higher reintervention rate.
In extensive aneurysms, may be higher association with higher spinal cord ischemia rates. We need additional efforts are needed to improve outcomes and understanding appropriate application of different treatment options for patients with
complex aortic disease. Thank you.
- Thank you, and thank you Dr. Veith for the opportunity to present. So, acute aortic syndromes are difficult to treat and a challenge for any surgeon. In regionalization of care of acute aortic syndromes is now a topic of significant conversation. The thoughts are that you can move these patients
to an appropriate hospital infrastructure with surgical expertise and a team that's familiar with treating them. Higher volumes, better outcomes. It's a proven concept in trauma care. Logistics of time, distance, transfer mortality,
and cost are issues of concern. This is a study from the Nationwide Inpatient Sample which basically demonstrates the more volume, the lower mortality for ruptured abdominal aortic aneurysms. And this is a study from Clem Darling
and his Albany Group demonstrating that with their large practice, that if they could get patients transferred to their central hospital, that they had a higher incidence of EVAR with lower mortality. Basically, transfer equaled more EVARs and a
lower mortality for ruptured abdominal aortic aneurysms. Matt Mell looked at interfacility transfer mortality in patients with ruptured abdominal aortic aneurysms to try to see if actually, transfer improved mortality. The take home message was, operative transferred patients
did do better once they reached the institution of destination, however they had a significant mortality during transfer that basically negated that benefit. And transport time, interestingly did not affect mortality. So, regional aortic management, I think,
is something that is quite valuable. As mentioned, access to specialized centers decrease overall mortality and morbidity potentially. In transfer mortality a factor, transport time does not appear to be. So, we set up a rapid transport system
at Keck Medical Center. Basically predicated on 24/7 coverage, and we would transfer any patient within two hours to our institution that called our hotline. This is the number of transfers that we've had over the past three years.
About 250 acute aortic transfers at any given... On a year, about 20 to 30 a month. This is a study that we looked at, that transport process. 183 patients, this is early on in our experience. We did have two that expired en route. There's a listing of the various
pathologies that we treated. These patients were transferred from all over Southern California, including up to Central California, and we had one patient that came from Nevada. The overall mortality is listed here. Ruptured aortic aneurysms had the highest mortality.
We had a very, very good mortality with acute aortic dissections as you can see. We did a univariate and multivariate analysis to look at factors that might have affected transfer mortality and what we found was the SVS score greater than eight
had a very, very significant impact on overall mortality for patients that were transferred. What is a society for vascular surgery comorbidity score? It's basically an equation using cardiac pulmonary renal hypertension and age. The asterisks, cardiac, renal, and age
are important as I will show subsequently. So, Ben Starnes did a very elegant study that was just reported in the Journal of Vascular Surgery where he tried to create a preoperative risk score for prediction of mortality after ruptured abdominal aortic aneurysms.
He found four factors and did an ROC curve. Basically, age greater than 76, creatinine greater than two, blood pressure less than 70, or PH less than 7.2. As you can see, as those factors accumulated there was step-wise increased mortality up to 100% with four factors.
So, rapid transport to regional aortic centers does facilitate the care of acute aortic syndromes. Transfer mortality is a factor, however. Transport mode, time, distance are not associated with mortality. Decision making to deny and accept transfer is evolving
but I think renal status, age, physiologic insult are important factors that have been identified to determine whether transfer should be performed or not. Thank you very much.
- Thank you. I have two talks because Dr. Gaverde, I understand, is not well, so we- - [Man] Thank you very much. - We just merged the two talks. All right, it's a little joke. For today's talk we used fusion technology
to merge two talks on fusion technology. Hopefully the rest of the talk will be a little better than that. (laughs) I think we all know from doing endovascular aortic interventions
that you can be fooled by the 2D image and here's a real life view of how that can be an issue. I don't think I need to convince anyone in this room that 3D fusion imaging is essential for complex aortic work. Studies have clearly shown it decreases radiation,
it decreases fluoro time, and decreases contrast use, and I'll just point out that these data are derived from the standard mechanical based systems. And I'll be talking about a cloud-based system that's an alternative that has some advantages. So these traditional mechanical based 3D fusion images,
as I mentioned, do have some limitations. First of all, most of them require manual registration which can be cumbersome and time consuming. Think one big issue is the hardware based tracking system that they use. So they track the table rather than the patient
and certainly, as the table moves, and you move against the table, the patient is going to move relative to the table, and those images become unreliable. And then finally, the holy grail of all 3D fusion imaging is the distortion of pre-operative anatomy
by the wires and hardware that are introduced during the course of your procedure. And one thing I'd like to discuss is the possibility that deep machine learning might lead to a solution to these issues. How does 3D fusion, image-based 3D fusion work?
Well, you start, of course with your pre-operative CT dataset and then you create digitally reconstructed radiographs, which are derived from the pre-op CTA and these are images that resemble the fluoro image. And then tracking is done based on the identification
of two or more vertebral bodies and an automated algorithm matches the most appropriate DRR to the live fluoro image. Sounds like a lot of gobbledygook but let me explain how that works. So here is the AI machine learning,
matching what it recognizes as the vertebral bodies from the pre-operative CT scan to the fluoro image. And again, you get the CT plus the fluoro and then you can see the overlay with the green. And here's another version of that or view of that.
You can see the AI machine learning, identifying the vertebral bodies and then on your right you can see the fusion image. So just, once again, the AI recognizes the bony anatomy and it's going to register the CT with the fluoro image. It tracks the patient, not the table.
And the other thing that's really important is that it recognizes the postural change that the patient undergoes between the posture during the CT scan, versus the posture on the OR table usually, or often, under general anesthesia. And here is an image of the final overlay.
And you can see the visceral and renal arteries with orange circles to identify them. You can remove those, you can remove any of those if you like. This is the workflow. First thing you do is to upload the CT scan to the cloud.
Then, when you're ready to perform the procedure, that is downloaded onto the medical grade PC that's in your OR next to your fluoro screen, and as soon as you just step on the fluoro pedal, the CYDAR overlay appears next to your, or on top of your fluoro image,
next to your regular live fluoro image. And every time you move the table, the computer learning recognizes that the images change, and in a couple of seconds, it replaces with a new overlay based on the obliquity or table position that you have. There are some additional advantages
to cloud-based technology over mechanical technology. First of all, of course, or hardware type technology. Excuse me. You can upgrade it in real time as opposed to needing intermittent hardware upgrades. Works with any fluoro equipment, including a C-arm,
so you don't have to match your 3D imaging to the brand of your fluoro imaging. And there's enhanced accuracy compared to mechanical registration systems as imaging. So what are the clinical applications that this can be utilized for?
Fluoroscopy guided endovascular procedures in the lower thorax, abdomen, and pelvis, so that includes EVAR and FEVAR, mid distal TEVAR. At present, we do need two vertebral bodies and that does limit the use in TEVAR. And then angioplasty stenting and embolization
of common iliac, proximal external and proximal internal iliac artery. Anything where you can acquire a vertebral body image. So here, just a couple of examples of some additional non EVAR/FEVAR/TEVAR applications. This is, these are some cases
of internal iliac embolization, aortoiliac occlusion crossing, standard EVAR, complex EVAR. And I think then, that the final thing that I'd like to talk about is the use with C-arm, which is think is really, extremely important.
Has the potential to make a very big difference. All of us in our larger OR suites, know that we are short on hybrid availability, and yet it's difficult to get our institutions to build us another hybrid room. But if you could use a high quality 3D fusion imaging
with a high quality C-arm, you really expand your endovascular capability within the operating room in a much less expensive way. And then if you look at another set of circumstances where people don't have a hybrid room at all, but do want to be able to offer standard EVAR
to their patients, and perhaps maybe even basic FEVAR, if there is such a thing, and we could use good quality imaging to do that in the absence of an actual hybrid room. That would be extremely valuable to be able to extend good quality care
to patients in under-served areas. So I just was mentioning that we can use this and Tara Mastracci was talking yesterday about how happy she is with her new room where she has the use of CYDAR and an excellent C-arm and she feels that she is able to essentially run two rooms,
two hybrid rooms at once, using the full hybrid room and the C-arm hybrid room. Here's just one case of Dr. Goverde's. A vascular case that he did on a mobile C-arm with aortoiliac occlusive disease and he places kissing stents
using a CYDAR EV and a C-arm. And he used five mils of iodinated contrast. So let's talk about a little bit of data. This is out of Blain Demorell and Tara Mastrachi's group. And this is use of fusion technology in EVAR. And what they found was that the use of fusion imaging
reduced air kerma and DSA runs in standard EVAR. We also looked at our experience recently in EVAR and FEVAR and we compared our results. Pre-availability of image based fusion CT and post image based fusion CT. And just to clarify,
we did have the mechanical product that Phillip's offers, but we abandoned it after using it a half dozen times. So it's really no image fusion versus image fusion to be completely fair. We excluded patients that were urgent/emergent, parallel endographs, and IBEs.
And we looked at radiation exposure, contrast use, fluoro time, and procedure time. The demographics in the two groups were identical. We saw a statistically significant decrease in radiation dose using image based fusion CT. Statistically a significant reduction in fluoro time.
A reduction in contrast volume that looks significant, but was not. I'm guessing because of numbers. And a significantly different reduction in procedure time. So, in conclusion, image based 3D fusion CT decreases radiation exposure, fluoro time,
and procedure time. It does enable 3D overlays in all X-Ray sets, including mobile C-arm, expanding our capabilities for endovascular work. And image based 3D fusion CT has the potential to reduce costs
and improve clinical outcomes. Thank you.
- Thank you very much for the opportunity to speak carbon dioxide angiography, which is one of my favorite topics and today I will like to talk to you about the value of CO2 angiography for abdominal and pelvic trauma and why and how to use carbon dioxide angiography with massive bleeding and when to supplement CO2 with iodinated contrast.
Disclosures, none. The value of CO2 angiography, what are the advantages perhaps? Carbon dioxide is non-allergic and non-nephrotoxic contrast agent, meaning CO2 is the only proven safe contrast in patients with a contrast allergy and the renal failure.
Carbon dioxide is very highly soluble (20 to 30 times more soluble than oxygen). It's very low viscosity, which is a very unique physical property that you can take advantage of it in doing angiography and CO2 is 1/400 iodinated contrast in viscosity.
Because of low viscosity, now we can use smaller catheter, like a micro-catheter, coaxially to the angiogram using end hole catheter. You do not need five hole catheter such as Pigtail. Also, because of low viscosity, you can detect bleeding much more efficiently.
It demonstrates to the aneurysm and arteriovenous fistula. The other interesting part of the CO2 when you inject in the vessel the CO2 basically refluxes back so you can see the more central vessel. In other words, when you inject contrast, you see only forward vessel, whereas when you inject CO2,
you do a pass with not only peripheral vessels and also see more central vessels. So basically you see the vessels around the lesions and you can use unlimited volumes of CO2 if you separate two to three minutes because CO2 is exhaled by the respirations
so basically you can inject large volumes particularly when you have long prolonged procedures, and most importantly, CO2 is very inexpensive. Where there are basically two methods that will deliver CO2. One is the plastic bag system which you basically fill up with a CO2 tank three times and then empty three times
and keep the fourth time and then you connect to the delivery system and basically closest inject for DSA. The other devices, the CO2mmander with the angio assist, which I saw in the booth outside. That's FDA approved for CO2 injections and is very convenient to use.
It's called CO2mmander. So, most of the CO2 angios can be done with end hole catheter. So basically you eliminate the need for pigtail. You can use any of these cobra catheters, shepherd hook and the Simmons.
If you look at this image in the Levitor study with vascular model, when you inject end hole catheter when the CO2 exits from the tip of catheter, it forms very homogenous bolus, displaces the blood because you're imaging the blood vessel by displacing blood with contrast is mixed with blood, therefore as CO2
travels distally it maintains the CO2 density whereas contrast dilutes and lose the densities. So we recommend end hole catheter. So that means you can do an arteriogram with end hole catheter and then do a select arteriogram. You don't need to replace the pigtail
for selective injection following your aortographies. Here's the basic techniques: Now when you do CO2 angiogram, trauma patient, abdominal/pelvic traumas, start with CO2 aortography. You'll be surprised, you'll see many of those bleeding on aortogram, and also you can repeat, if necessary,
with CO2 at the multiple different levels like, celiac, renal, or aortic bifurcation but be sure to inject below diaphragm. Do not go above diaphragm, for example, thoracic aorta coronary, and brachial, and the subclavian if you inject CO2, you'll have some serious problems.
So stay below the diaphragm as an arterial contrast. Selective injection iodinated contrast for a road map. We like to do super selective arteriogram for embolization et cetera. Then use a contrast to get anomalies. Super selective injection with iodinated contrast
before embolization if there's no bleeding then repeat with CO2 because of low viscocity and also explosion of the gas you will often see the bleeding. That makes it more comfortable before embolization. Here is a splenic trauma patient.
CO2 is injected into the aorta at the level of the celiac access. Now you see the extra vascularization from the low polar spleen, then you catheterize celiac access of the veins. You microcatheter in the distal splenic arteries
and inject the contrast. Oops, there's no bleeding. Make you very uncomfortable for embolizations. We always like to see the actual vascularization before place particle or coils. At that time you can inject CO2 and you can see
actual vascularization and make you more comfortable before embolization. You can inject CO2, the selective injection like in here in a patient with the splenic trauma. The celiac injection of CO2 shows the growth, laceration splenic with extra vascularization with the gas.
There's multiple small, little collection. We call this Starry Night by Van Gogh. That means malpighian marginal sinus with stagnation with the CO2 gives multiple globular appearance of the stars called Starry Night.
You can see the early filling of the portal vein because of disruption of the intrasplenic microvascular structures. Now you see the splenic vein. Normally, you shouldn't see splenic vein while following CO2 injections.
This is a case of the liver traumas. Because the liver is a little more anterior the celiac that is coming off of the anterior aspect of the aorta, therefore, CO2 likes to go there because of buoyancy so we take advantage of buoyancy. Now you see the rupture here in this liver
with following the aortic injections then you inject contrast in the celiac axis to get road map so you can travel through this torus anatomy for embolizations for the road map for with contrast. This patient with elaston loss
with ruptured venal arteries, massive bleeding from many renal rupture with retro peritoneal bleeding with CO2 and aortic injection and then you inject contrast into renal artery and coil embolization but I think the stent is very dangerous in a patient with elaston loss.
We want to really separate the renal artery. Then you're basically at the mercy of the bleeding. So we like a very soft coil but basically coil the entire renal arteries. That was done. - Thank you very much.
- Time is over already? - Yeah. - Oh, OK. Let's finish up. Arteriogram and we inject CO2 contrast twice. Here's the final conclusions.
CO2 is a valuable imaging modality for abdominal and pelvic trauma. Start with CO2 aortography, if indicated. Repeat injections at multiple levels below diaphragm and selective injection road map with contrast. The last advice fo
t air contamination during the CO2 angiograms. Thank you.
- Mr Chairman, dear colleagues. I've nothing to disclose. We know that aneurysm or dilation of the common iliac artery is present in almost 20% of cases submitted to endovascular repair and we have a variety of endovascular solution available. The first one is the internal iliac artery
embolization and coverage which is very technically easy but it's a suboptimal choice due to the higher risk of thrombosis and internal iliac problems. So the flared limbs landing in the common iliac artery is technically easy,
however, the results in the literature are conflicting. Iliac branch devices is a more demanding procedure but has to abide to a specific anatomical conditions and is warranted by good results in the literature such as this work from the group in Perugia who showed a technical success of almost 100%
as you can see, and also good results in other registries. So there are unresolved question about this problem which is the best choice in this matter, flared limbs or iliac branch devices. In order to solve this problem, we have looked at our data,
published them in Journal Vascular Interventional Neurology and this is our retrospective observational study involving treatment with either flared limbs or IBD and these are the flared limbs devices we used in this study. Anaconda, Medtronic, Cook and Gore.
And these are the IFU of the two IBD which were used in this study which were Gore-IBE and Cook-ZBS. So we looked at the 602 EVAR with 105 flared limbs which were also fit for IBD. And on the other side, we looked at EVAR-IBD
implanted in the same period excluding those implanted outside the IFU. So we ended up with 57 cases of IBD inside the IFU. These are the characteristics of the two groups of patients. The main important finding was the year age which was a little younger in the IBD group
and the common iliac artery diameter which was greater, again in the IBD group. So this is the distribution of the four types of flared limbs devices and IBD in the two groups. And as you can see, the procedural time and volume of contrast medium was significantly
higher in the IBD group. Complications did not differ significantly however, overall there were four iliac complication and all occurred in the flared limbs group. When we went to late complications, putting together all the iliac complication, they were significantly
greater in the flared limbs group compared with the IBD with zero percent complication rate. Late complications were always addressed by endovascular relining or relining and urokinase in case of infusion, in case of thrombosis. And as you can see here, the late outcome
did not differ significantly in the two groups. However, when we put together all the iliac complication, the iliac complication free survival was significantly worse in the flared limbs group. So in conclusion, flared limbs and IBD have similar perioperative outcomes.
IBD is more technically demanding, needs more contrast medium and time obviously. The complications in flared limbs are all resolvable by endovascular means and IBD has a better outcome in the long term period. So the take-home message of my presentation
is that we prefer IBD in young patients with high life expectancy and in the presence of anatomical risk factors of flared limbs late complications. Thank you for your attention.
- Thank you Tal. It's a privilege again to take the podium here. No disclosures. Everyone in here in this audience understands how important Traumatic Aortic Injury is, the second leading cause of death, primarily due to blunt mechanisms,
that are well known to the trauma and vascular community. And, we've learned a lot about how to care for these patient's in the transition in the vascular age. And, that began with the American Association for the Surgery of Trauma Studies in 2008 and 2009, which showed that TEVAR was associated
with an improved mortality and decreased paraplegia compared to older modalities. And, these are the graphs at my old training grounds at UT Houston, which, I'm sure would be the same at most other centers. A gradual transition to almost completely TEVAR
for every patient who has appropriate anatomy. And, we now have over a decade worth of survival data to show the outcome comparisons are the same as the older modalities. But the question has become now, are we over treating some of these injuries?
We need an optimal algorithm and an optimal algorithm requires an optimal grading system. And, that grading system should determine the treatment we utilize, it should guide the timing of the treatment. And, should provide some prediction of the natural history
in those patient's that we do not immediately treat. The SVS in 2011 developed a very nice anatomical based grading system, however, this is a lesionology type algorithm if you will, and not incorporating any of the valuable information that the patient also may possess
in terms of associated injuries. There have been alternative proposals: Vancouver, the Harborview "Minimal Aortic Injuries" is one that is very familiar and commonly utilized in the literature. And, even the Baltimore Classification which includes some physiology elements.
And the reality is, there are also other elements of ongoing issues Blunt Thoracic Aortic Injury, including not only how to manage those Grade 1/Grade 2 injuries but the timing of repair. How do we prioritize repair in the context of other sev
rain Injury and other bleeding solid organs and what's the optimal follow up regimen for these patients? It was with those questions in mind that 3 years ago we developed the Aortic Trauma Foundation. This is a non-profit organization with a Multispecialty
International Medical Advisory Board and a Board of Directors. We really wanted to improve outcomes of patient's with Traumatic Aortic Injury through education and research. We started with several initial, kind of low hanging fruit exercises, the first of which was a practice pattern survey
from members of the SVS, trauma organization, thoracic surgery organizations in interventional radiology and we found that there were some contingents here, and some very interesting findings in this survey. In fact, a majority of providers who care for these injuries don't rely on any guidelines at all.
Just their own personal knowledge of literature and their experience over their practice lifespan. Likewise, these mid-grade injuries represent some significant controversy with almost half the providers thinking that these just need medical therapy and observation as an outpatient.
And the remainder treating them emergently with TEVAR. Or, urgently with TEVAR. And we also conducted a large Retrospective Multicenter Study, 382 patient's from US Level 1 Trauma Centers and we found the at TEVAR compared to Open Repair
was associated with lower transfusion, lower overall mortality, lower aortic related mortality. None of these were surprising findings. But again, this study identified some controversy here, particularly with the, there's no difference in outcomes with those Minimal BTAI patient's if they're treated
with TEVAR or undergo medical non-operative management. Which suggests at least that in some of these patient's we are actually over-treating them. We have, as ongoing effort, our Aortic Trauma Foundation International, Multicenter PROSPECTIVE Blunt Thoracic Aortic Injury Registry
designed to identify predictors of early rupture, develop some multi-specialty consensus guidelines on treatment and management and establish long term outcomes. Anyone in this audience can join this effort, we have always gotten good contribution from VEITH.
We have a region based involvement, mechanism to promote the not only ATF involvement but the prospective registry in the US and abroad. And, we've had some good results. This initial registry went live in 2016, as of 2018, we have 381 patient's
in 23 centers internationally. And we plan to do a feasibility report when we cross the 500 patient threshold. And we invite anyone who seeks to become a member of the Aortic Trauma Foundation and actively contributes to utilize this data.
We all want to as a community, identify and define optimal care practices. We are going to actively solicit and review proposals for use and we hope that this data will produce a foundational platform upon which we can develop some really meaningful multi-specialty guidelines
that are evidence and practice based. Thank you.
- Thank you Mr. Chairman. Ladies and gentleman, first of all, I would like to thank Dr. Veith for the honor of the podium. Fenestrated and branched stent graft are becoming a widespread use in the treatment of thoracoabdominal
and pararenal aortic aneurysms. Nevertheless, the risk of reinterventions during the follow-up of these procedures is not negligible. The Mayo Clinic group has recently proposed this classification for endoleaks
after FEVAR and BEVAR, that takes into account all the potential sources of aneurysm sac reperfusion after stent graft implant. If we look at the published data, the reported reintervention rate ranges between three and 25% of cases.
So this is still an open issue. We started our experience with fenestrated and branched stent grafts in January 2016, with 29 patients treated so far, for thoracoabdominal and pararenal/juxtarenal aortic aneurysms. We report an elective mortality rate of 7.7%.
That is significantly higher in urgent settings. We had two cases of transient paraparesis and both of them recovered, and two cases of complete paraplegia after urgent procedures, and both of them died. This is the surveillance protocol we applied
to the 25 patients that survived the first operation. As you can see here, we used to do a CT scan prior to discharge, and then again at three and 12 months after the intervention, and yearly thereafter, and according to our experience
there is no room for ultrasound examination in the follow-up of these procedures. We report five reinterventions according for 20% of cases. All of them were due to endoleaks and were fixed with bridging stent relining,
or embolization in case of type II, with no complications, no mortality. I'm going to show you a couple of cases from our series. A 66 years old man, a very complex surgical history. In 2005 he underwent open repair of descending thoracic aneurysm.
In 2009, a surgical debranching of visceral vessels followed by TEVAR for a type III thoracoabdominal aortic aneurysms. In 2016, the implant of a tube fenestrated stent-graft to fix a distal type I endoleak. And two years later the patient was readmitted
for a type II endoleak with aneurysm growth of more than one centimeter. This is the preoperative CT scan, and you see now the type II endoleak that comes from a left gastric artery that independently arises from the aneurysm sac.
This is the endoleak route that starts from a branch of the hepatic artery with retrograde flow into the left gastric artery, and then into the aneurysm sac. We approached this case from below through the fenestration for the SMA and the celiac trunk,
and here on the left side you see the superselective catheterization of the branch of the hepatic artery, and on the right side the microcatheter that has reached the nidus of the endoleak. We then embolized with onyx the endoleak
and the feeding vessel, and this is the nice final result in two different angiographic projections. Another case, a 76 years old man. In 2008, open repair for a AAA and right common iliac aneurysm.
Eight years later, the implant of a T-branch stent graft for a recurrent type IV thoracoabdominal aneurysm. And one year later, the patient was admitted again for a type IIIc endoleak, plus aneurysm of the left common iliac artery. This is the CT scan of this patient.
You will see here the endoleak at the level of the left renal branch here, and the aneurysm of the left common iliac just below the stent graft. We first treated the iliac aneurysm implanting an iliac branched device on the left side,
so preserving the left hypogastric artery. And in the same operation, from a bowl, we catheterized the left renal branch and fixed the endoleak that you see on the left side, with a total stent relining, with a nice final result on the right side.
And this is the CT scan follow-up one year after the reintervention. No endoleak at the level of the left renal branch, and nice exclusion of the left common iliac aneurysm. In conclusion, ladies and gentlemen, the risk of type I endoleak after FEVAR and BEVAR
is very low when the repair is planning with an adequate proximal sealing zone as we heard before from Professor Verhoeven. Much of reinterventions are due to type II and III endoleaks that can be treated by embolization or stent reinforcement. Last, but not least, the strict follow-up program
with CT scan is of paramount importance after these procedures. I thank you very much for your attention.
- Thank you very much again. Thank you very much for the kind invitation. The answer to the question is, yes or no. Well, basically when we're talking about pelvic reflux, we're talking really, about, possibly thinking about two separate entities. One symptoms relate to the pelvis
and issues with lower limb varicose veins. Really some time ago, we highlighted in a review, various symptoms that may be associated with the pelvic congestion syndrome. This is often, either misdiagnosed or undiagnosed. The patients we see have had multiple investigations
prior to treatment. I'm not really going to dwell on the anatomy but, just really highlight to you it is incompetence in either the renal pelvic and ovarian veins. What about the patterns of reflux we've heard from both Mark and Nicos what the pattern are
but, basically if you look a little more closely you can see that not only the left ovarian vein is probably effected in a round-about 60%. But, there is incompetence in many of the other veins. What does this actually have implication for with respect to treatment.
Implications are that you probably, if you only treat an isolated vein. There is a suggestion, that the long term outcomes are not actually as good. Now this is some work from Mark Whiteley's group because, we've heard about the diagnosis
but, there is some discussion as to whether just looking at ovarian vein diameter is efficient and certainly the Whiteley group suggests that actually diameter is relatively irrelevant in deciding as to whether there is incompetence in the actual vein itself.
That diameter should not be used as a single indicator. You may all well be aware, that there are reporting standards for the treatment of pelvic venous insufficiency and this has been high-lighted in this paper. What of the resuts, of pelvic embolization and coiling? The main standard is used, is a visual analog scale
when you're looking at pelvic symptoms to decide what the outcome may be. This is a very nice example of an article that was... A review that was done in Niel Khilnani's group and you can see if you look at the pre
and post procedural visual analog scales there is some significant improvement. You can see that this is out at one year in the whole. Now, this is a further table from the paper. Showing you their either, there's a mixture
of glue, coils, scleroses and foam. The comments are that, there are significant relief and some papers suggest its after 100% and others up to 80%. If you look at this very nice review that Mark Meissner did with Kathy Gibson,
you will see that actually no improvement in worse. There's quite a range there for those patients 53% of patients in one study, had no improvement or the symptoms were potentially worse. We know that those patients who have coil embolization will have reoccurrence of symptomatology
and incompetence up to about a quarter of the patients. What about varicose veins? The answer is there is undoubtedly evidence to suggest that there is physiological/anatomical incompetence in some of the pelvic veins in patients
who have recurrent varicose veins. Whether this is actually a direct cause or an association, I think it's something we need to have some further consideration of. As you know, there are many people who now would advicate actually treating
the pelvic veins prior to treating the leg veins. You can maybe discuss that in the question time. If we then look at a comparative trial. Comparing coils and plugs, you can see over all there really isn't no particular difference. If we then look again to highlight this,
which comes again from the Whiteley group. You can see that 20% of patients will have some primary incompetence but, it'll go up to around 30% if they are re-current. There is no randomized control data looking at this. What are the problems with coils?
Actually, a bit like (mumbling) you can find them anywhere. You can find them in the chest and also you can find that there are patients now who are allergic to nickel and the very bottom corner is a patient who's coils I took out by open laparotomy because they were allergic to nickel.
So, ladies and gentlemen I would suggest to you certainly, for continuing with pelvic embolization when doubtedly it needs some more RCT data and some much better registry data to look where we're going. Thank you very much.
- Thank you, good morning everybody. Thank you for the kind invitation, Professor Veith, it's an honor for me to be here again this year in New York. I will concentrate my talk about the technical issues and the experience in the data we have already published about the MISACE in more than 50 patients.
So I have no disclosure regarded to this topic. As you already heard, the MISACE means the occlusion of the main stem of several segmental arteries to preserve the capability of the collateral network to build new arteries. And as a result, we developed
the ischemic preconditioning of the spinal cord. Why is this so useful? Because it's an entirely endovascular first stage of a staged approach to treat thoracoabdominal aortic aneurysm in order to reduce the ischemic spinal cord injury.
How do you perform the MISACE? Basically, we perform the procedure in local anesthesia, through a percutaneous trans-femoral access using a small-bore sheath. The patient is awake, that means has no cerebrospinal fluid damage
so we can monitor the patient's neurological for at least 48 hours after the procedure. So, after the puncture of the common femoral artery, using a technique of "tower of power" in order to cannulate the segmental arteries. As you can see here, we started with a guiding catheter,
then we place a diagnosis catheter and inside, a microcatheter that is placed inside the segmental artery. Then we started occlusion of the ostial segment of the segmental artery. We use coils or vascular plugs.
We don't recommend the use of fluids due to the possible distal embolization and the consequences. Since we have started this procedure, we have gained a lot of experience and we have started to ask,
what is a sufficient coilembolization? As you can see here, this artery, we can see densely packed coils inside, but you can see still blood flowing after the coil. So, was it always occluding, or is it spontaneous revascularization?
That, we do not know yet. The question, is it flow reduction enough to have a ischemic precondition of the spinal cord? Another example here, you can see a densely packed coil in the segmental artery at the thoracic level. There are some other published data
with some coils in the segm the question is, which technique should we use, the first one, the second one? Another question, is which kind of coil to use? For the moment, we can only use the standard coils
in our center, but I think if we have 3-D or volume coils or if you have microvascular plugs that are very compatible with the microcatheter, we have a superior packing density, we can achieve a better occlusion of the segmental artery, and we have less procedure time and radiation time,
but we have to think of the cost. We recommend to start embolization of the segmental artery, of course, at the origin of it, and not too far inside. Here, you can see a patient where we have coiled a segmental artery very shortly after the ostium,
but you can see here also the development of the collaterals just shortly before the coils, leading to the perfusion of segmental artery that was above it. As you can see, we still have a lot of open question. Is it every patent segmental artery
a necessary to coil? Should we coil only the large ones? I show you an example here, you can see this segmental artery with a high-grade stenotic twisted ostium due to aortic enlargement.
I can show you this segmental artery, six weeks after coiling of a segmental artery lower, and you can see that the ostium, it's no more stenotic and you can see also the connection between the segmental artery below to the initial segmental artery.
Another question that we have, at which level should we start the MISACE? Here, can see a patient with a post-dissection aneurysm after pedicle technique, so these are all uncovered dissection stent, and you can see very nicely the anterior spinal artery
feeded by the anterior radiculomedullary artery from the segmental artery. So, in this patient, in fact, we start the coiling exactly at the seat of this level, we start to coil the segmental artery that feeds the anterior spinal artery.
So, normally we find this artery of the Th 9 L1, and you can see here we go upwards and downwards. We have some challenges with aneurysm sac enlargement, in this case, we use this technique to open the angle of the catheter, we can use also deflectable steerable sheath
in order to reach the segmental artery. And you can see here our results, again, I just will go fast through those, we have treated 57 patients, most of them were Type II, Type III aortic aneurysms. We have found in median nine patent segmental artery
at the level of the aorta to be treated, between 2 and 26, and we have coiled in multiple sessions with a mean interval of 60 days between the sessions. No sooner than seven days we perform the complete exclusion of the aneurysm
in order to let the collateral to develop, and you can see our result: at 30 days we had no spinal cord ischemia. So I can conclude that our first experience suggest that MISACE is feasible, safe, and effective, but segmental artery coiling in thoracoabdominal aneurysm
can be challenging, it's a new field with many open questions, and I looking forward for the results with PAPA_ARTiS study. Thank you a lot.
- [Presenter] Thank you very much, Mr. Chairman, and ladies and gentlemen, and Frank Veith for this opportunity. Before I start my talk, actually, I can better sit down, because Hans and I worked together. We studied in the same city, we finished our medical study there, we also specialized in surgery
in the same city, we worked together at the same University Hospital, so what should I tell you? Anyway, the question is sac enlargement always benign has been answered. Can we always detect an endoleak, that is nice. No, because there are those hidden type II's,
but as Hans mentioned, there's also a I a and b, position dependent, possible. Hidden type III, fabric porosity, combination of the above. Detection, ladies and gentlemen, is limited by the tools we have, and CTA, even in the delayed phase
and Duplex-scan with contrast might not always be good enough to detect these lesions, these endoleaks. This looks like a nice paper, and what we tried to do is to use contrast-enhanced agents in combination with MRI. And here you see the pictures. And on the top you see the CTA, with contrast,
and also in the delayed phase. And below, you see this weak albumin contrast agent in an MRI and shows clearly where the leak is present. So without this tool, we were never able to detect an endoleak with the usual agents. So, at this moment, we don't know always whether contrast
in the Aneurysm Sac is only due to a type II. I think this is an important message that Hans pushed upon it. Detection is limited by the tools we have, but the choice and the success of the treatment is dependent on the kind of endoleak, let that be clear.
So this paper has been mentioned and is using not these advanced tools. It is only using very simple methods, so are they really detecting type II endoleaks, all of them. No, of course not, because it's not the golden standard. So, nevertheless, it has been published in the JVS,
it's totally worthless, from a scientific point of view. Skip it, don't read it. The clinical revelance of the type II endoleak. It's low pressure, Hans pointed it out. It works, also in ruptured aneurysms, but you have to be sure that the type II is the only cause
of Aneurysm Sac Expansion. So, is unlimited Sac Expansion harmless. I agree with Hans that it is not directly life threatening, but it ultimately can lead to dislodgement and widening of the neck and this will lead to an increasing risk for morbidity and even mortality.
So, the treatment of persistent type II in combination with Sac Expansion, and we will hear more about this during the rest of the session, is Selective Coil-Embolisation being preferred for a durable solution. I'm not so much a fan of filling the Sac, because as was shown by Stephan Haulan, we live below the dikes
and if we fill below the dikes behind the dikes, it's not the solution to prevent rupture, you have to put something in front of the dike, a Coil-Embolisation. So classic catheterisation of the SMA or Hypogastric, Trans Caval approach is now also popular,
and access from the distal stent-graft landing zone is our current favorite situation. Shows you quickly a movie where we go between the two stent-grafts in the iliacs, enter the Sac, and do the coiling. So, prevention of the type II during EVAR
might be a next step. Coil embolisation during EVAR has been shown, has been published. EVAS, is a lot of talks about this during this Veith meeting and the follow-up will tell us what is best. In conclusions, the approach to sac enlargement
without evident endoleak. I think unlimited Sac expansion is not harmless, even quality of life is involved. What should your patient do with an 11-centimeter bilp in his belly. Meticulous investigation of the cause of the Aneurysm Sac
Expansion is mandatory to achieve a, between quote, durable treatment, because follow-up is crucial to make that final conclusion. And unfortunately, after treatment, surveillance remains necessary in 2017, at least. And this is Hans Brinker, who put his finger in the dike,
to save our country from a type II endoleak, and I thank you for your attention.
- Thank you and thanks again Frank for the kind invitation to be here another year. So there's several anatomic considerations for complex aortic repair. I wanted to choose between fenestrations or branches,
both with regards to that phenotype and the mating stent and we'll go into those. There are limitations to total endovascular approaches such as visceral anatomy, severe angulations,
and renal issues, as well as shaggy aortas where endo solutions are less favorable. This paper out of the Mayo Clinic showing that about 20% of the cases of thoracodynia aneurysms
non-suitable due to renal issues alone, and if we look at the subset that are then suitable, the anatomy of the renal arteries in this case obviously differs so they might be more or less suitable for branches
versus fenestration and the aneurysm extent proximally impacts that renal angle. So when do we use branches and when do we use fenestrations? Well, overall, it seems to be, to most people,
that branches are easier to use. They're easier to orient. There's more room for error. There's much more branch overlap securing those mating stents. But a branch device does require
more aortic coverage than a fenestrated equivalent. So if we extrapolate that to juxtarenal or pararenal repair a branched device will allow for much more proximal coverage
than in a fenestrated device which has, in this series from Dr. Chuter's group, shows that there is significant incidence of lower extremity weakness if you use an all-branch approach. And this was, of course, not biased
due to Crawford extent because the graft always looks the same. So does a target vessel anatomy and branch phenotype matter in of itself? Well of course, as we've discussed, the different anatomic situations
impact which type of branch or fenestration you use. Again going back to Tim Chuter's paper, and Tim who only used branches for all of the anatomical situations, there was a significant incidence of renal branch occlusion
during follow up in these cases. And this has been reproduced. This is from the Munster group showing that tortuosity is a significant factor, a predictive factor, for renal branch occlusion
after branched endovascular repair, and then repeated from Mario Stella's group showing that upward-facing renal arteries have immediate technical problems when using branches, and if you have the combination of downward and then upward facing
the long term outcome is impaired if you use a branched approach. And we know for the renals that using a fenestrated phenotype seems to improve the outcomes, and this has been shown in multiple trials
where fenestrations for renals do better than branches. So then moving away from the phenotype to the mating stent. Does the type of mating stent matter? In branch repairs we looked at this
from these five major European centers in about 500 patients to see if the type of mating stent used for branch phenotype grafts mattered. It was very difficult to evaluate and you can see in this rather busy graph
that there was a combination used of self-expanding and balloon expandable covered stents in these situations. And in fact almost 2/3 of the patients had combinations in their grafts, so combining balloon expandable covered stents
with self expanding stents, and vice versa, making these analyses very very difficult. But what we could replicate, of course, was the earlier findings that the event rates with using branches for celiac and SMA were very low,
whereas they were significant for left renal arteries and if you saw the last session then in similar situations after open repair, although this includes not only occlusions but re-interventions of course.
And we know when we use fenestrations that where we have wall contact that using covered stents is generally better than using bare stents which we started out with but the type of covered stent
also seems to matter and this might be due to the stiffness of the stent or how far it protrudes into the target vessel. There is a multitude of new bridging stents available for BEVAR and FEVAR: Covera, Viabahn, VBX, and Bentley plus,
and they all seem to have better flexibility, better profile, and better radial force so they're easier to use, but there's no long-term data evaluating these devices. The technical success rate is already quite high for all of these.
So this is a summary. We've talked using branches versus fenestration and often a combination to design the device to the specific patient anatomy is the best. So in summary,
always use covered stents even when you do fenestrated grafts. At present, mix and match seems to be beneficial both with regards to the phenotype and the mating stent. Short term results seem to be good.
Technical results good and reproducible but long term results are lacking and there is very limited comparative data. Thank you. (audience applauding)
- I'd like to thank Dr. Veith for this kind invitation and the committee as well. So these are my disclosures, there's none. So for a quick background regarding closure devices. Vascular closure devices have been around
for almost 20 years, various types. Manual compression in most studies have always been shown to be superior to vascular closure devices mainly because there's been no ideal device that's been innovated to be able
to handle all sorts of anatomies, which include calcified vessels, soft plaque, etc. So in this particular talk we wanted to look at to two particular devices. One is the Vascade vascular closure device
made by Cardiva and the other is the CELT arterial closure device made by Vasorum in Ireland. Both these devices are somewhat similar in that they both use a disc. The Vascade has a nitinol disc
as you can see here that's used out here to adhere to the interior common femoral artery wall. And then once tension is applied, a series of steps is involved to deploy the collagen plug
directly on to the artery which then allows it to expand over a period of time. The CELT is similar in that it also uses a stainless steel disc as you can see here. Requires tension up against the interior wall of the common femoral artery.
Nice and tight and then you screw on the top end of the device on to the interior wall of the artery creating a nice little cylinder that compresses both walls of artery. As far as comparability is concerned between the two devices you can see
here that they're both extravascular, one's nitinol, one's stainless steel. One uses a collagen material, the other uses an external clip in a spindle-type fashion. Both require about, anywhere between three to seven minutes of pressure
to essentially stop the tract ooze. But the key differences between the two devices, is the amount of time it takes for patients to ambulate. So the ambulation time is two hours roughly for Vascade, whereas for a CELT device
it's anywhere from being immediate off the table at the cath lab room to about 20 minutes. The data for Vascade was essentially showing the RESPECT trial which I'll summarize here, With 420 patients that was a randomized trial
to other manual compression or the device itself. The mean points of this is that the hemostasis time was about three minutes versus 21 minutes for manual compression. And time to ambulation was about 3.2 hours versus 5.7 hours.
No major complications were encountered. There were 1.1% of minor complications in the Vascade versus 7% in the manual compression arm. This was actually the first trial that showed that a actual closure devices
had better results than manual compression. The main limitations in the trial didn't involved complex femoral anatomy and renal insufficiency patients which were excluded. The CELT ACD trial involved 207 patients that were randomized to CELT or to manual
compression at five centers. Time to hemostasis was anywhere between zero minutes on average versus eight minutes in the manual compression arm. There was one complication assessed at 30 days and that was a distal embolization that occurred
early on after the deployment with a successfully retrieved percutaneously with a snare. So complication rate in this particular trial was 0.7% versus 0% for manual compression. So what are some pros and cons with the Vascade device?
Well you can see the list of pros there. The thing to keep in mind is that it is extravascular, it is absorbable, it's safe, low pain tolerance with this and the restick is definitely possible. As far as the cons are involved.
The conventional bedrest time is anywhere between two to three hours. It is a passive closure device and it can create some scarring when surgical exploration is necessary on surgical dissections.
The key thing also is you can not visualize the plug after deployment. The pros and cons of the CELT ACD device. You can see is the key is the instant definitive closure that's achieved with this particular device, especially in
calcified arteries as well. Very easy to visualize under fluoroscopy and ultrasound. It can be used in both antegrade and retrograde approaches. The key cons are that it's a permanent implant.
So it's like a star closed devised, little piece of stainless steel that sits behind. There's a small learning curve with the device. And of course there's a little bit of discomfort associated with the cinching under the (mumbles) tissue.
So we looked at our own experience with both devices at the Christie Clinic. We looked at Vascade with approximately 300 consecutive patients and we assessed their time to hemostasis, their time to ambulation,
and their time to discharge, as well as the device success and minor and major complications. And the key things to go over here is that the time to hemostasis was about 4.7 minutes for Vascade, at 2.1 hours for ambulation, and roughly an average
of 2.4 hours for discharge. The device success was 99.3% with a minor complication rate of .02% which we have four hematomas and two device failures requiring manual compression. The CELT ACD device we also similarly did
a non-randomized perspective single center trial assessing the same factors and assessing the patients at seven days. We had 400 consecutive patients enrolled. And you can see we did 232 retrograde. We did a little bit something different
with this one, we did we 168 antegrade but we also did direct punctures to the SFA both at the proximal and the mid-segments of the SFA. And the time to hemostasis in this particular situation was 3.8 minutes,
ambulation was 18.3 minutes, and discharge was at 38.4 minutes. We did have two minor complications. One of which was a mal-deployment of the device requiring manual compression. And the second one was a major complication
which was an embolization of the device immediately after deployment which was done successfully snared through an eighth front sheath. So in conclusion both devices are safe and effective and used for both
antegrade and retrograde access. They're definitely comparable when it comes, from the standpoint of both devices (mumbles) manual compression and they're definitely really cost effective in that they definitely do increase the
throughput in the cath lab allowing us to be able to move patients through our cath lab in a relatively quick fashion. Thank you for your attention.
- Thank you. We've all heard that hypogastric artery occlusion can be not so benign as Dr. Snyder mentioned. It's not advancing, there we go. There's the systematic meta-analysis of 61 papers and showing that when you have bilateral occlusion you actually can have worse symptoms
of claudication, even erectile dysfunction. There are these known commercially available devices but should we be doing bilateral cases? There's certainly increased complexity inherent in this and anatomic limitations and cost. We choose to look at a multicenter experience
of 24 centers, 47 patients. Here are the contributing contributors. When we published our experience these are the 47 patients using the GORE IBE device both in Europe and the United States with 6.5 month follow up. The aortic diameters, some of the characteristics.
You can see here that 23% had exclusive iliac aneurysm treatment in the absence of a AAA. Four had aneurysmal or ectatic internal iliac arteries. These are sometimes treated by coil embolizing the first branch and extending the internal branch into a first order branch, there you can see.
But anatomic limitations persist and you can see especially with lengths. You need quite a long length for that ipsilateral side with its device in order to do the bilateral case. These are the IFUs, 165 for the contra and 195 for the ipsi. In our experience you can see that actually 194 on the ipsi
and 195 is what we found as a mean. This seems prohibitive. Some of the tips and tricks to accommodate the shorter lengths are shown here. We can maximize overlap, and we can see that from 195 we can drop this
by maximizing the overlap to 175. We can certainly cross the limbs, that eats up some length. Intrinsic tortuosity can eat up the distance. We can see we can recreate the flow divider, bring up the flow divider higher, match the two limbs. That also can cut down the distance.
Finally in some of these patients we had shorter bridging stents, the endurant stent in particular is a little shorter instead of the 100 millimeter Gore limb and that can also shorten the distance. More about the procedural outcomes. You can see here great technical success.
There were no type one or type three endoleaks. There were some adjunctive stenting in some patients, four patients, because of some kinking and distal dissection. One technical failure's worth pointing out. This is a patient who has heavy calcification
in the iliac system here. Couldn't cannulate, the internal iliac artery required coil embolization. You can see this patient, we had to sacrifice that internal and extend into the external. Complications at 30 days are very acceptable.
One groin infection. You can see that radiographing clinical follow up. One patient with new buttock claudications, a patient who lost the internal iliac artery as I'll mention to you in a minute. The other one was asymptomatic
but also one internal iliac artery lost. No aneurysm related deaths. You can see there's some type two endoleaks but not type one or three endoleaks. More about limb occlusions. This is the external iliac limb.
You can see there were three external iliac limb occlusions, two in the perioperative period and one at six months which presented with claudication requiring a Fem-Fem. The two in the perioperative period, one was a thrombectomy and stent that was treated nicely. The other one was really an iatrogenic limb occlusion
because the internal branch was deployed inadvertently high jailing the external and causing the operators to have to go back and essentially sacrifice that internal in order to preserve flow to the external. You can see that this a patient who in fact did have the claudication symptoms, this is that one patient.
As far as internal iliac limb occlusion in addition to the one we just described there was one asymptomatic incidental find of a limb occlusion at six months. This is a comparison of what Dr. Snyder just discussed, the pivotal trial with expanded access to the global experience I just presented.
You can see when you look at fluoroscopy time, for instance, contrast media used or procedural duration that there is, of course, some increase requirement in the bilateral cases but I would argue that this is not prohibitive. Cost, however, may in fact be an issue.
Certainly this can be a quite costly procedure when we start doing bilateral cases. There are, in fact, new procedure codes that Gore has provided that can offset some of this cost especially for the hospital cost, but nonetheless this is something to be considered.
So in conclusion, preservation of bilateral internal iliac artery with a Gore IBE can be performed safely with excellent technical results and short term patency rates. Only one new onset of buttock claudication occurred in that inadvertent limb jailing. Limb and branch occlusions are rare but can be treated
successfully with stenting most of the time. Some anatomic limitations exist but a number of maneuvers can permit technical success even in shorter length aortoiliac segments. Contrast fluoroscopy and length of case do not appear to be prohibitive.
However, cost remains an issue. Thank you.
- Thank you. Thank you to the Veith for inviting me again for this meeting. So, we're going to deal about optimal treatment of asymptomatic patients with carotid stenosis. I have no financial disclosures. So, the first thing to say about the treatment
of each patient is intensive medical therapy and this has been discussed before. Smoking cessation, low-dose aspirin, statins to maximum tolerated dose, angiotensin converting enzyme inhibitor, and optimal blood pressure control.
Essentially, they are recommendation 1A. But, the adherence to medical therapy has never been evaluated in landmark RCTs and never evaluated for secondary prevention in patient with asymptomatic carotid stenosis. And you see here, in a study by Chen,
that among more than 1000 patient with vascular disease, range of adherence to guideline-recommended therapies at three month was not optimal. It was quite good for aspirin, lower for statins, and even lower for ACEIs. The other thing is that the recommendation for surgery
or any kind of revascularization in the asymptomatic patient with more than 60% carotid stenosis rely on ACAS and ACST trial that are fairly updated. And you see in this column, in the ACAS trial, the rate in the medical arm, the rate of stroke, ipsilateral stroke per year, 2.2%.
In 2004, in ACST first part, it was 1.1% per year, and then, in ACST year six to 10, published in 2010, it was 0.7%. So finally, we added, you know, significantly, the munition of the risk of stroke in the medical arm of nearly 60%.
And this is, in relation, we've arrived at the best medical therapy. Nothing must change for antiplatelet use, but still stable, around 90% of the patient, but you see a rise of antihypertensive drug from 50% to 90%,
and the dramatic rise of lipid-lowering drug from 10% to nearly 80%. And when you see this consequence in ACST-1, the net benefits of carotid endarterectomy were significant both for those on lipid-lowering therapy and for those not.
So, the main idea is that not all asymptomatic patient need a revascularization, but degree of stenosis is not all. In asymptomatic patients, risk of stroke seems for us to be more related to the structure of the plaque than to the degree of stenosis.
And you see, and so we suggest the following clinical and imaging features associated with an increased risk of stroke in these patients with asymptomatic carotid stenosis treated medically. Contralateral TIA stroke with odds ratio three,
cerebral imaging with ipsilateral silent brain infarct, ultrasound imaging with progression of stenosis, spontaneous embolization on TCD, large plaque, echolucent plaque, HITS on TCD plus echolucent plaque, and finally, an MRI intraplaque hemorrhage.
And it has been shown that asymptomatic patients with silent infraction have a higher risk of ipsilateral stroke, 3.6% versus 1%. On the same area, embolic signals on TCD in patient with asymptomatic carotid stenosis are associated with a higher risk of stroke.
So, we end with this recommendation. Carotid stenosis 60 to 99, life expectancy more than five years. One or more than one features that we described suggesting higher risk of stroke, and this is class IIa B.
Calculated B plus, best medical treatment, should be considered. We've a lower recommendation for CAS, maybe can consider it. No indication for string sign with occlusion or near occlusion. We flat out treated with best medical treatment only.
Just a word on carotid endarterectomy versus stenting in the asymptomatic patient. Due to a recent technique of CAS for the familiar approach in asymptomatic patient, CAS is associated with a significantly higher risk of stroke
and death rate at 30 days. So our recommendation is lower. So this recommendation were made by a group of people, 85 authors and reviewers agree with it, on these recommendations, and you can then well subscribe
in the European Journal of Vascular Surgery, or in the European Heart Journal. Thank you.
- Here are my disclosures, none are relevant to today's talks. So what is the role of compressions stockings to prevent Postthrombotic Syndrome for patients with acute DVT? Well it's become rather complicated because as shown by recent studies,
it depends on what question is being asked. Question one is do compression stockings started at the time of DVT diagnosis prevent PTS, such as the Socks trial and other similar trials? Or question two, if you're already worn compression stockings for a period of time after DVT
and have not developed PTS, does stopping them increase the risk of developing PTS, such as the recent OCTAVIA and IDEAL trials? This is a meta-analysis that was done to address question one, namely the role of compression stockings started at the time of DVT diagnosis,
and this meta-analysis considered unblinded studies. The one blinded study, which was the Socks trial, and then attempted to combine that data, and you can see that if one looks at the unblinded studies there's suggestion of a 30% protective effect, or, excuse me, 40% protective effect.
The blinded study showed no effect of compression stockings. And combining all the studies together seemed to show about a 30% protective effect, however the confidence interval crossed one. There's very low confidence in this total estimate because of the substantial heterogeneity across studies.
And indeed, in their discussion, the authors point out the following: "We have very serious concerns about the unblinded studies because such designs may inflate treatment effects". And also, "differing results across studies suggest that the decision to use compression stockings
may be value and preference dependent for our patients". And we'll come back to that shortly. What about question two, if you've already worn compression stockings for a period of time after DVT, and you haven't developed PTS, does stopping them increase the risk of getting PTS?
There've been two new trials. One is the OCTAVIA study, of 518 proximal DVT patients. All wore compression stockings for one year after their DVT. If they were free of PTS at one year, they were randomized to continue for an additional year, or to stop.
And the results of this trial showed that stopping after one year was inferior to continuing for two years for the PTS outcome. On the other hand, we have the IDEAL study, of 865 proximal DVT patients. In this study, all patients wore compression stockings
for six months after proximal DVT, and if they were free of PTS at six months, they were randomized to continue for an additional 18 months, or to tailor continued use of stockings according to the Villalta score that was assessed every three months
at study follow-up visits. And the results of this trial showed that tailoring use after six months, which was the experimental arm, was actually non-inferior to continuing for 18 more months. So these results are interesting but somewhat conflicting. So how do I use compression stockings in 2018?
I don't routinely prescribe stockings to all of my proximal DVT patients. They can be difficult to apply, uncomfortable, expensive, and they need to be replaced every few months. And we all know that many patients won't wear them
in real life, especially if they have no symptoms whatsoever. And also, it's really not clear to me whether stockings prevent Postthrombotic Syndrome versus merely palliate symptoms of Postthrombotic Syndrome that has already developed.
And it may simply be as effective and more convenient and we may achieve better compliance if we ask our patients to start compression stockings at the time they develop symptoms of Postthrombotic Syndrome. I do however prescribe a trial of stockings
to any DVT patient, whether they have proximal or distal DVT who has residual symptoms after their DVT, and I'd continue them for as long as the patient derives symptomatic benefit or is able to tolerate them, and I certainly take patients' values and preferences into account
in making this decision. Moving on to the role of interventional treatment for patients with acute DVT. We have all heard and seen the results of the ATTRACT trial. Just very briefly, we know that the primary study outcome, any Postthrombotic Syndrome was not different
in the PCDT arm versus the No-PCDT arm. However, it did appear that PCDT reduced the risk of developing moderate or severe Postthrombotic Syndrome, and this was driven primarily by the subgroup with Iliofemoral DVT. In terms of short-term results, PCDT caused more
bleeding, major and any bleeding, and it caused statistically significant but clinically modest improvements in leg pain and leg swelling. Based on these results, what's the role of interventional treatment for patients with acute DVT? I would say that it's not indicated for routine use
in proximal DVT, it doesn't prevent Postthrombotic Syndrome, it does increase bleeding, and older patients above the age of 60 to 65 or more appear to be particularly poor candidates because of more bleeding and less efficacy. And further study in clinical use of these modalities
should be targeted. One would still consider PCDT in patients with severe symptoms, Iliofemoral DVT, and the other factors shown here on the slide. And finally, always remember that it's always an option to anticoagulate first for the initial
five to seven days if the limb is not acutely threatened. Thank you very much.
- Thank you, Ulrich. Before I begin my presentation, I'd like to thank Dr. Veith so kindly, for this invitation. These are my disclosures and my friends. I think everyone knows that the Zenith stent graft has a safe and durable results update 14 years. And I think it's also known that the Zenith stent graft
had such good shrinkage, compared to the other stent grafts. However, when we ask Japanese physicians about the image of Zenith stent graft, we always think of the demo version. This is because we had the original Zenith in for a long time. It was associated with frequent limb occlusion due to
the kinking of Z stent. That's why the Spiral Z stent graft came out with the helical configuration. When you compare the inner lumen of the stent graft, it's smooth, it doesn't have kink. However, when we look at the evidence, we don't see much positive studies in literature.
The only study we found was done by Stephan Haulon. He did the study inviting 50 consecutive triple A patients treated with Zenith LP and Spiral Z stent graft. And he did two cases using a two iliac stent and in six months, all Spiral Z limb were patent. On the other hand, when you look at the iliac arteries
in Asians, you probably have the toughest anatomy to perform EVARs and TEVARs because of the small diameter, calcification, and tortuosity. So this is the critical question that we had. How will a Spiral Z stent graft perform in Japanese EIA landing cases, which are probably the toughest cases?
And this is what we did. We did a multi-institutional prospective observational study for Zenith Spiral Z stent graft, deployed in EIA. We enrolled patients from June 2017 to November 2017. We targeted 50 cases. This was not an industry-sponsored study.
So we asked for friends to participate, and in the end, we had 24 hospitals from all over Japan participate in this trial. And the board collected 65 patients, a total of 74 limbs, and these are the results. This slide shows patient demographics. Mean age of 77,
80 percent were male, and mean triple A diameter was 52. And all these qualities are similar to other's reporting in these kinds of trials. And these are the operative details. The reason for EIA landing was, 60 percent had Common Iliac Artery Aneurysm.
12 percent had Hypogastric Artery Aneurysm. And 24 percent had inadequate CIA, meaning short CIA or CIA with thrombosis. Outside IFU was observed in 24.6 percent of patients. And because we did fermoral cutdowns, mean operative time was long, around three hours.
One thing to note is that we Japanese have high instance of Type IV at the final angio, and in our study we had 43 percent of Type IV endoleaks at the final angio. Other things to notice is that, out of 74 limbs, 11 limbs had bare metal stents placed at the end of the procedure.
All patients finished a six month follow-up. And this is the result. Only one stenosis required PTA, so the six months limb potency was 98.6 percent. Excellent. And this is the six month result again. Again the primary patency was excellent with 98.6 percent. We had two major adverse events.
One was a renal artery stenosis that required PTRS and one was renal stenosis that required PTA. For the Type IV index we also have a final angio. They all disappeared without any clinical effect. Also, the buttock claudication was absorbed in 24 percent of patients at one month, but decreased
to 9.5 percent at six months. There was no aneurysm sac growth and there was no mortality during the study period. So, this is my take home message, ladies and gentlemen. At six months, Zenith Spiral Z stent graft deployed in EIA was associated with excellent primary patency
and low rate of buttock claudication. So we have most of the patients finish a 12 month follow-up and we are expecting excellent results. And we are hoping to present this later this year. - [Host] Thank you.
- I will be talking about new KDOQI guidelines. I know many of you have heard about KDOQI guidelines being revised for the past maybe over a year or maybe two. Yes, it is being done, and it is going slow only because it's being done in a very different way. It's more than an update.
It's going to be more of an overhaul for the entire KDOQI guidelines. We in KDOQI have looked at access as a solitary problem like we talked about grafts, catheters, fistulas for access, but actually it sort of turns out
that access is part of a bigger problem. Fits into a big ESKD lifeline of a patient. Instated distal patients come in many varieties. It can affect any age, and they have a lot of other problems so once you have chronic renal failure, renal replacement mortality fits in
only when it becomes Stage IV or Stage V. And renal replacement mortality is not just access, it is PD access, it's hemo access, it is transplant. So these things, we need to see how they fit in in a given person. So the new KDOQI guidelines concentrates more
on individualizing care. For example, here the young Darien was an 11 year old with a prune belly syndrome. Now he has failed PD. Then there's another person here who is Lydia who is about 36 or 40 year old lady
with a insulin dependent diabetes. Already has bad vascular pedicle. Lost both legs. Needs access. Now both these patient though they need access, it's not the same.
It's different. For example, if you think of Darien, he was in PD but he has failed PD. We would love to get him transplanted. Unfortunately he's got terrible social situation so we can't get him transplanted.
So he needs hemo. Now if he needs hemo, we need to find an access that lasts for a long time because he's got many years ahead of him. On the other hand we have Lydia, who has got significant vascular disease.
With her obesity and existing infectious status, probably PD won't be a good option for her. So she needs hemo, and she's obviously not a transplant candidate. So how are we going to plan for hemo? So these are things which we are to more concentrate
and individualize when we look at patients, and the new guidelines concentrate more on these sort of aspects. Doing right access for right patient, right time, and for right reasons. And we go about planning this keeping the patient first
then a life plan ESKD lifeline for the patient, and what access we are looking at, and what are the needs of the patient? Now this is also different because it has been done more scientifically. We actually have a evidence review team.
We just poured over pretty much 1500 individual articles. Recent articles. And we have looked through about 4000 abstracts and other articles. And this data is correlated through a workgroup. There a lot of new chapters.
Chapter specific surgery like peri-operative, intra-operative, post-operative, cat issues, managing complication issues. And we started off with the coming up with the Scope of Work. The evidence review team took the Scope of Work
and tried to get all the articles and sift through the articles and came up and rated the evidence using a certain rating system which is very scientific. The workgroup then kind of evaluated the whole system, and then came up with what is clinically relevant.
It's one thing for statisticians to say how strong evidence this is, but it's another thing how it is looked upon by the clinicians. So then we kind of put this into a document. Document went through internal and external review process.
This is the process we have tried to do it. Dr. Lok has been the Chair of the group. Myself and Dr. Yevzlin are the Vice-Chairs. We have incredible workgroup which has done most of the work. And here are the workgroup members.
We comprised of nephrologist, transplant surgeons, vascular surgeons, Allied Health personnel, pediatric nephrologist so it's a multi interventional radiologist and interventional nephrologist. This is a multi disciplinary group which has gone through this process.
Timothy Wilt from Minnesota was the head of the Evidence Review Team, who has worked on the evidence building. And now for the editorial sections we have Dr. Huber, Lee, and Dr. Lok taking care of it. So where are we today?
We have pretty much gone through the first part of it. We are at the place where we are ready for the Internal Review and External Review. So many of you probably will get a chance to look through it when it comes for the External Review and would love
to have your comments on this document. Essentially, we are looking at access in the context of end stage renal disease, and that is new. And obviously we have gone through and done a very scientific review, a very scientific methodology to try
to evaluate the evidence and try to come up with guidelines. Thank you.
- Thank you for introduction. Thanks to Frank Veith for the kind invitation to present here our really primarily single-center experience on this new technique. This is my disclosure. So what you really want
in the thromboembolic acute events is a quick flow restoration, avoid lytic therapies, and reduce the risk of bleeding. And this can be achieved by surgery. However, causal directed local thrombolysis
is much less invasive and also give us a panoramic view and topographic view that is very useful in these cases. But it takes time and is statistically implied
and increases risk of bleeding. So theoretically percutaneous thrombectomy can accomplish all these tasks including a shorter hospital stay. So among the percutaneous thrombectomy devices the Indigo System is based on a really simple
aspiration mechanism and it has shown high success in ischemic stroke. This is one of my first cases with the Indigo System using a 5 MAX needle intervention
adapted to this condition. And it's very easy to understand how is fast and effective this approach to treat intraprocedural distal embolization avoiding potential dramatic clinical consequences, especially in cases like this,
the only one foot vessel. This is also confirmed by this technical note published in 2015 from an Italian group. More recently, other papers came up. This, for example, tell us that
there has been 85% below-the-knee primary endpoint achievement and 54% in above-the-knee lesions. The TIMI score after VAT significantly higher for BTK lesions and for ATK lesions
a necessity of a concomitant endovascular therapy. And James Benenati has already told us the results of the PRISM trials. Looking into our case data very quickly and very superficially we can summarize that we had 78% full revascularization.
In 42% of cases, we did not perform any lytic therapy or very short lytic therapy within three hours. And in 36% a long lytic therapy was necessary, however within 24 hours. We had also 22% failure
with three surgery necessary and one amputation. I must say that among this group of patients, twenty patients, there were also patients like this with extended thrombosis from the groin to the ankle
and through an antegrade approach, that I strongly recommend whenever possible, we were able to lower the aspiration of the clots also in the vessel, in the tibial vessels, leaving only this region, thrombosis
needed for additional three hour infusion of TPA achieving at the end a beautiful result and the patient was discharged a day after. However not every case had similar brilliant result. This patient went to surgery and he went eventually to amputation.
Why this? And why VAT perform better in BTK than in ATK? Just hypotheses. For ATK we can have unknown underlying chronic pathology. And the mismatch between the vessel and the catheter can be a problem.
In BTK, the thrombus is usually soft and short because it is an acute iatrogenic event. Most importantly is the thrombotic load. If it is light, no short, no lytic or short lytic therapy is necessary. Say if heavy, a longer lytic therapy and a failure,
regardless of the location of the thrombosis, must be expected. So moving to the other topic, venous occlusive thrombosis. This is a paper from a German group. The most exciting, a high success rate
without any adjunctive therapy and nine vessels half of them prosthetic branch. The only caution is about the excessive blood loss as a main potential complication to be checked during and after the procedure. This is a case at my cath lab.
An acute aortic renal thrombosis after a open repair. We were able to find the proximate thrombosis in this flush occlusion to aspirate close to fix the distal stenosis
and the distal stenosis here and to obtain two-thirds of the kidney parenchyma on both sides. And this is another patient presenting with acute mesenteric ischemia from vein thrombosis.
This device can be used also transsympatically. We were able to aspirate thrombi but after initial improvement, the patient condition worsened overnight. And the CT scan showed us a re-thrombosis of the vein. Probably we need to learn more
in the management of these patients especially under the pharmacology point of view. And this is a rapid overview on our out-of-lower-limb case series. We had good results in reimplanted renal artery, renal artery, and the pulmonary artery as well.
But poor results in brachial artery, fistula, and superior mesenteric vein. So in conclusion, this technology is an option for quick thromboembolic treatment. It's very effective for BTK intraprocedural embolic events.
The main advantage is a speeding up the blood flow and reestablishing without prolonged thrombolysis or reducing the dosage of the thrombolysis. Completely cleaning up extensive thromobosed vessels is impossible without local lytic therapies. This must be said very clearly.
Indigo technology is promising and effective for treatment of acute renovisceral artery occlusion and sub massive pulmonary embolism. Thank you for your attention. I apologize for not being able to stay for the discussion
because I have a flight in a few hours. Thank you very much.
- Great, thanks Jeff. Welcome everyone. I was actually going to more talk about a wish list for ZFEN plus after some discussion with our industry partners. There's still not quite a final lock yet on the final device so due to various reasons we'll go over kind of a
review of the U.S. fenestrated data and then some of the things that I hope are some of the current limitations. This is our personal experience right now since the approval. 159 commercial ZFEN devices.
Still a reasonable proportion of parallel grafting for urgent or challenging cases. I think everybody acknowledges that obviously creating a seal zone above the renal arteries provides more seal for a standard infrarenal strategy. In fact because the U.S. device the instructions for use
call for a four to 14 millimeter infrarenal neck you wind up adding that in addition to the space that's across the renal arteries as well as the seal generally up to the scallop, or if you're building a large fenestration for the SMA, all the way up to the celiac.
Graft diameters from 22 to 36, the 36 millimeter device being on a 22 French system. The remainder of them being on a 20 French system. Remember that in the U.S. that we can only build three of these holes, if you will, and you can only have two maximum of one of the types meaning the general build
is two small fenestrations for the renals and either a scallop or large fenestration for the superior mesenteric artery. The results of the U.S. prospective trial have been presented and published multiple times in the past but basically in the original study
most of them under general anesthesia. Total amount of procedure time about three to four hours. The device implant time about two hours. Technical success achieved in everyone with all visceral vessels patent on the completion run. 30 day mortality excellent, the one problem
was with bowel ischemia. Major adverse events sort of immediately post op also related to bowel ischemia but no conversion, ruptures, or renal function decline. And at pre-discharge CTA all target vessels patent without any type one or junctional endoleaks.
Hospital stay two to three days. The later follow up paper, follow up out to three years with excellent outcomes related to problems with type one or type three endoleaks and the renal outcomes also excellent. Three patients with renal function deterioration.
But, a reasonable number of renal stent exclusions and stenoses which I do believe should be counted against the technology. And the reninterventions needed in a reasonable number of patients. So a primary patency of 81%
on the Capellan Meyer out to five years. When you look at then sort of early post approval outcomes, which is what we would consider more real world studies, when we looked at the first seven or eight sites that had early access right after approval we looked at this data and it turned out much like
what we would all do if we get our hands on newer technology now. More than two thirds, or just under two thirds of patients actually did not meet the recommended anatomic criteria of a four to 14 millimeter infrarenal neck but despite this the 30 day outcomes
compared to the U.S. data. This is a paper that just came out from the University of Indiana. First hundred patients since the ZFEN approval excellent outcomes but again still a reasonable reintervention rate mainly going after these renal branches.
This was our first one, a very sort of standard infrarenal short neck with a scallop and such built. Most of our builds now are with a large fenestration and bilateral renals. So what do we really need? I think in the newer device.
Well I think everybody wants something that's a little smaller access. We've had to use a reasonable number of both endo and open iliac conduits. I still think the angulation makes things difficult. These cases that have the SMA close to the renals
in the current construct do not allow us to build a device that makes it work for that. We've had to come up with various strategies when the SMA is lower than the higher renal. So I think really the future devices we need to work on the wait time, something with better renal branches
and a smaller access. Thanks.
- The committee asked me to give an update on the Cook p-Branch device which is in a clinical trial in the United States. This is the disclosures as it relates to this talk. I'm going to discuss the feasibility as well as the pivotal study as you see on this slide. Now these two studies, as you can imagine,
have a different number of patients. The feasibility study was done in 30 patients and, as all studies in the U.S., required a five-year follow-up. And the p-Branch pivotal study is involving 82 patients with also a five-year follow-up, with the objectives really to assess the device's
safety and effectiveness and primary endpoints, treatment at one year. Now, the feasibility study enrolled 30 patients at 10 U.S. sites over a two and a half year period, roughly. So here the mean age was 73 years and maximum aneurysm diameter's 65 millimeters
and proximal neck length with the enrolled patients was 21 millimeters. The distribution of A configuration where the two renal pivot fenestration's are at the same level is 57% and the B configuration which is an offset was 43% of the patients.
About 226 mean operative time, slightly more or close to 70 minutes of fluoro time and about one day in the ICU, and three, four days in the hospital. There were two technical problems, the first two patients enrolled at the same site for the trial,
had the p-Branch deployed below the renal arteries due to difficulty with the cannulation and the case done the following day also had a technical failure by not being able to get in a renal. This prompted an update and some physician training and proctoring so that we actually sent proctors to sites,
and the next 28 cases were all successful. Overall, in the feasibility study, 30 day mortality is 0%. Three deaths in the late phase, after 30 days from a cerebral aneurysm. Dissection at slightly less than a year of a proximal
thoracic aneurysm and cardiomyopathy. Freedom from all-cause mortality was 93% in one year, and 89% at 2 years. No ruptures or surgical conversion to date as of last year, when we locked the data. 28 mean follow-up.
Now, if you look at the renal artery patency, which is what all of us are looking at for these types of studies, you see primary patency of stinted renal arteries for this study is on the left. And if you compare that to the initial p-Branch, a single study that was published last year, very similar.
As well as the ZFEN multicenter trial, you see the patencies are quite similar. What about secondary interventions? If you look at this table, we've plotted out secondary interventions at 30 days, and overall, you see the p-Branch feasibility study
slightly higher, but not statistically significant between that and the p-Branch single-center. And the ZFEN is quite low with the 1%. Overall, the secondary interventions were about a third of the patients in most of these studies. Well, what about the pivotal studies?
They said this is an ongoing trial, it's been going on for about three years, we've had about three quarters of the patients enrolled after three years, and we have 28 active sites. We have data on the first 51 patients enrolled, and you see the high enrollers there on the far right.
The mean age is very similar to the feasibility study. 71 years of age, most patients are male, slightly over six centimeters for the diameter, and approximately one millimeter longer at 22 versus 21. The distribution of A and B is also quite similar, as you see here, slightly more A than B,
anywhere from the 55 to 60% range for most all of these studies. Procedures time with the 28 cites now is very similar, 258 minutes, slightly less than the prior study. And you see the fluro time and days in the ICU and discharge very similar.
At 30 days in those 51 patients, no deaths, no renal or bowel ischemia, no neurologic complications or rupture. There had been 3 occlusions of fenestrated vessels, left and renal artery occlusion at day 23, 23, and 30, so these are most likely technical issues
that the stint is crushed. And we've look at that and we'll continue to monitor that. Two patients had re-intervention subsequently, and no patients developed renal insufficiency renal failure at the time of this analysis. So, overall, patient selection, physican technical
abilities, and proper device training will continue to be important for p-Branch implementation and implantation. The feasibility study, early and intermediate results support its safety and feasibility of off-the-shelf device. Follow-up through five years is ongoing. Enrolled is going to continue for the pivotal study
and currently we need less than 20 cases to complete. Thank you.
- Yeah now, I'm talking about another kind of vessel preparation device, which is dedicated to prevent the occurrence of embolic events and with these complications. That's a very typical appearance of an occluded stent with appositional stent thrombosis up to the femur bifurcation.
If you treat such a lesion simply with balloon angioplasty, you will frequently see some embolic debris going downstream, residing in this total occlusion of the distal pocket heel artery as a result of an embolus, which is fixed at the bifurcation of
the anterior tibial and the tibial planar trunk, what you can see over here. So rates of macro embolization have been described as high as 38% after femoral popliteal angioplasty. It can be associated with limb loss.
There is a risk of limb loss may be higher in patients suffering from poor run-off and critical limb ischemia. There is a higher rate of embolization for in-stent restenosis, in particular, in occluded stents and chronic total occlusions.
There is a higher rate of cause and longer lesions. This is the Vanguard IEP system. It's an integrated balloon angioplasty and embolic protection device. You can see over here, the handle. There is a rotational knob, where you can,
a top knob where you can deploy, and recapture the filter. This is the balloon, which is coming into diameters and three different lengths. This is the filter, 60 millimeter in length. The pore size is 150 micron,
which is sufficient enough to capture relevant debris going downstream. The device is running over an 80,000 or 14,000 guide-wire. This is a short animation about how the device does work. It's basically like a traditional balloon.
So first of all, we have to cross the lesion with a guide-wire. After that, the device can be inserted. It's not necessary to pre-dilate the lesion due to the lower profile of the capture balloon. So first of all, the capture filter,
the filter is exposed to the vessel wall. Then you perform your pre-dilatation or your dilatation. You have to wait a couple of second until the full deflation of the balloon, and then you recapture the filter, and remove the embolic debris.
So when to use it? Well, at higher risk for embolization, I already mentioned, which kind of lesions are at risk and at higher risk of clinical consequences that should come if embolization will occur. Here visible thrombus, acute limb ischemia,
chronic total occlusion, ulceration and calcification, large plaque volume and in-stent reocclusion of course. The ENTRAP Study was just recently finished. Regarding enrollment, more than 100 patients had been enrolled. I will share with you now the results
of an interim analysis of the first 50 patients. It's a prospective multi-center, non-randomized single-arm study with 30-day safety, and acute performance follow-up. The objective was to provide post-market data in the European Union to provide support for FDA clearance.
This is the balloon as you have seen already. It's coming in five and six millimeter diameter, and in lengths of 80, 120 and 200 millimeters. This is now the primary safety end point at 30 days. 53 subjects had been enrolled. There was no event.
So the safety composite end point was reached in 100%. The device success was also 100%. So all those lesions that had been intended to be treated could be approached with the device. The device could be removed successfully. This is a case example with short lesion
of the distal SFA. This is the device in place. That's the result after intervention. That's the debris which was captured inside the filter. Some more case examples of more massive debris captured in the tip of the filter,
in particular, in longer distance total occlusions. Even if this is not a total occlusion, you may see later on that in this diffused long distance SFA lesion, significant debris was captured. Considering the size of this embolus,
if this would have been a patient under CLI conditions with a single runoff vessel, this would have potentially harmed the patient. Thank you very much.
- Good morning, thank you, Dr. Veith, for the invitation. My disclosures. So, renal artery anomalies, fairly rare. Renal ectopia and fusion, leading to horseshoe kidneys or pelvic kidneys, are fairly rare, in less than one percent of the population. Renal transplants, that is patients with existing
renal transplants who develop aneurysms, clearly these are patients who are 10 to 20 or more years beyond their initial transplantation, or maybe an increasing number of patients that are developing aneurysms and are treated. All of these involve a renal artery origin that is
near the aortic bifurcation or into the iliac arteries, making potential repair options limited. So this is a personal, clinical series, over an eight year span, when I was at the University of South Florida & Tampa, that's 18 patients, nine renal transplants, six congenital
pelvic kidneys, three horseshoe kidneys, with varied aorto-iliac aneurysmal pathologies, it leaves half of these patients have iliac artery pathologies on top of their aortic aneurysms, or in place of the making repair options fairly difficult. Over half of the patients had renal insufficiency
and renal protective maneuvers were used in all patients in this trial with those measures listed on the slide. All of these were elective cases, all were technically successful, with a fair amount of followup afterward. The reconstruction priorities or goals of the operation are to maintain blood flow to that atypical kidney,
except in circumstances where there were multiple renal arteries, and then a small accessory renal artery would be covered with a potential endovascular solution, and to exclude the aneurysms with adequate fixation lengths. So, in this experience, we were able, I was able to treat eight of the 18 patients with a fairly straightforward
endovascular solution, aorto-biiliac or aorto-aortic endografts. There were four patients all requiring open reconstructions without any obvious endovascular or hybrid options, but I'd like to focus on these hybrid options, several of these, an endohybrid approach using aorto-iliac
endografts, cross femoral bypass in some form of iliac embolization with an attempt to try to maintain flow to hypogastric arteries and maintain antegrade flow into that pelvic atypical renal artery, and a open hybrid approach where a renal artery can be transposed, and endografting a solution can be utilized.
The overall outcomes, fairly poor survival of these patients with a 50% survival at approximately two years, but there were no aortic related mortalities, all the renal artery reconstructions were patented last followup by Duplex or CT imaging. No aneurysms ruptures or aortic reinterventions or open
conversions were needed. So, focus specifically in a treatment algorithm, here in this complex group of patients, I think if the atypical renal artery comes off distal aorta, you have several treatment options. Most of these are going to be open, but if it is a small
accessory with multiple renal arteries, such as in certain cases of horseshoe kidneys, you may be able to get away with an endovascular approach with coverage of those small accessory arteries, an open hybrid approach which we utilized in a single case in the series with open transposition through a limited
incision from the distal aorta down to the distal iliac, and then actually a fenestrated endovascular repair of his complex aneurysm. Finally, an open approach, where direct aorto-ilio-femoral reconstruction with a bypass and reimplantation of that renal artery was done,
but in the patients with atypical renals off the iliac segment, I think you utilizing these endohybrid options can come up with some creative solutions, and utilize, if there is some common iliac occlusive disease or aneurysmal disease, you can maintain antegrade flow into these renal arteries from the pelvis
and utilize cross femoral bypass and contralateral occlusions. So, good options with AUIs, with an endohybrid approach in these difficult patients. Thank you.
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