- So my charge is to talk about using band for steal. I have no relevant disclosures. We're all familiar with steal. The upper extremity particularly is able to accommodate for the short circuit that a access is with up to a 20 fold increase in flow. The problem is that the distal bed
is not necessarily as able to accommodate for that and that's where steal comes in. 10 to 20% of patients have some degree of steal if you ask them carefully. About 4% have it bad enough to require an intervention. Dialysis associated steal syndrome
is more prevalent in diabetics, connective tissue disease patients, patients with PVD, small vessels particularly, and females seem to be predisposed to this. The distal brachial artery as the inflow source seems to be the highest risk location. You see steal more commonly early with graft placement
and later with fistulas, and finally if you get it on one side you're very likely to get it on the other side. The symptoms that we are looking for are coldness, numbness, pain, at the hand, the digital level particularly, weakness in hand claudication, digital ulceration, and then finally gangrene in advanced cases.
So when you have this kind of a picture it's not too subtle. You know what's going on. However, it is difficult sometimes to differentiate steal from neuropathy and there is some interaction between the two.
We look for a relationship to blood pressure. If people get symptomatic when their blood pressure's low or when they're on the access circuit, that is more with steal. If it's following a dermatomal pattern that may be a median neuropathy
which we find to be pretty common in these patients. Diagnostic tests, digital pressures and pulse volume recordings are probably the best we have to assess this. Unfortunately the digital pressures are not, they're very sensitive but not very specific. There are a lot of patients with low digital pressures
that have no symptoms, and we think that a pressure less than 60 is probably consistent, or a digital brachial index of somewhere between .45 and .6. But again, specificity is poor. We think the digital pulse volume recordings is probably the most useful.
As you can see in this patient there's quite a difference in digital waveforms from one side to the other, and more importantly we like to see augmentation of that waveform with fistula compression not only diagnostically but also that is predictive of the benefit you'll get with treatment.
So what are our treatment options? Well, we have ligation. We have banding. We have the distal revascularization interval ligation, or DRIL, procedure. We have RUDI, revision using distal inflow,
and we have proximalization of arterial inflow as the approaches that have been used. Ligation is a, basically it restores baseline anatomy. It's a very simple procedure, but of course it abandons the access and many of these patients don't have a lot of good alternatives.
So it's not a great choice, but sometimes a necessary choice. This picture shows banding as we perform it, usually narrowing the anastomosis near the artery. It restricts flow so you preserve the fistula but with lower flows.
It's also simple and not very morbid to do. It's got a less predictable effect. This is a dynamic process, and so knowing exactly how tightly to band this and whether that's going to be enough is not always clear. This is not a good choice for low flow fistula,
'cause again, you are restricting flow. For the same reason, it's probably not a great choice for prosthetic fistulas which require more flow. So, the DRIL procedure most people are familiar with. It involves a proximalization of your inflow to five to 10 centimeters above the fistula
and then ligation of the artery just below and this has grown in popularity certainly over the last 10 or 15 years as the go to procedure. Because there is no flow restriction with this you don't sacrifice patency of the access for it. It does add additional distal flow to the extremity.
It's definitely a more morbid procedure. It involves generally harvesting the saphenous vein from patients that may not be the best risk surgical patients, but again, it's a good choice for low flow fistula. RUDI, revision using distal inflow, is basically
a flow restrictive procedure just like banding. You're simply, it's a little bit more complicated 'cause you're usually doing a vein graft from the radial artery to the fistula. But it's less complicated than DRIL. Similar limitations to banding.
Very limited clinical data. There's really just a few series of fewer than a dozen patients each to go by. Finally, a proximalization of arterial inflow, in this case rather than ligating the brachial artery you're ligating the fistula and going to a more proximal
vessel that often will accommodate higher flow. In our hands, we were often talking about going to the infraclavicular axillary artery. So, it's definitely more morbid than a banding would be. This is a better choice though for prosthetic grafts that, where you want to preserve flow.
Again, data on this is very limited as well. The (mumbles) a couple years ago they asked the audience what they like and clearly DRIL has become the most popular choice at 60%, but about 20% of people were still going to banding, and so my charge was to say when is banding
the right way to go. Again, it's effect is less predictable than DRIL. You definitely are going to slow the flows down, but remember with DRIL you are making the limb dependent on the patency of that graft which is always something of concern in somebody
who you have caused an ischemic hand in the first place, and again, the morbidity with the DRIL certainly more so than with the band. We looked at our results a few years back and we identified 31 patients who had steal. Most of these, they all had a physiologic test
confirming the diagnosis. All had some degree of pain or numbness. Only three of these patients had gangrene or ulcers. So, a relatively small cohort of limb, of advanced steal. Most of our patients were autogenous access,
so ciminos and brachycephalic fistula, but there was a little bit of everything mixed in there. The mean age was 66. 80% were diabetic. Patients had their access in for about four and a half months on average at the time of treatment,
although about almost 40% were treated within three weeks of access placement. This is how we do the banding. We basically expose the arterial anastomosis and apply wet clips trying to get a diameter that is less than the brachial artery.
It's got to be smaller than the brachial artery to do anything, and we monitor either pulse volume recordings of the digits or doppler flow at the palm or arch and basically apply these clips along the length and restricting more and more until we get
a satisfactory signal or waveform. Once we've accomplished that, we then are satisfied with the degree of narrowing, we then put some mattress sutures in because these clips will fall off, and fix it in place.
And basically this is the result you get. You go from a fistula that has no flow restriction to one that has restriction as seen there. What were our results? Well, at follow up that was about almost 16 months we found 29 of the 31 patients had improvement,
immediate improvement. The two failures, one was ligated about 12 days later and another one underwent a DRIL a few months later. We had four occlusions in these patients over one to 18 months. Two of these were salvaged with other procedures.
We only had two late recurrences of steal in these patients and one of these was, recurred when he was sent to a radiologist and underwent a balloon angioplasty of the banding. And we had no other morbidity. So this is really a very simple procedure.
So, this is how it compares with DRIL. Most of the pooled data shows that DRIL is effective in 90 plus percent of the patients. Patency also in the 80 to 90% range. The DRIL is better for late, or more often used in late patients,
and banding used more in earlier patients. There's a bigger blood pressure change with DRIL than with banding. So you definitely get more bang for the buck with that. Just quickly going through the literature again. Ellen Dillava's group has published on this.
DRIL definitely is more accepted. These patients have very high mortality. At two years 50% are going to be dead. So you have to keep in mind that when you're deciding what to do. So, I choose banding when there's no gangrene,
when there's moderate not severe pain, and in patients with high morbidity. As promised here's an algorithm that's a little complicated looking, but that's what we go by. Again, thanks very much.
- 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 again, Dr. Veith, for the kind invitation to talk about this topic. This year, these are my disclosure. In the last five years, we treated 76 cases of Fenestrated and Branched repair for torque abdominal unfit for open surgery. And we soon realized that the upper extremity access
is needed in almost up to 90% of the cases. The first cases were managed by standard cut down in high-brachial and brachial region, but as soon as we improved our skills in percutaneous approach for the groins, we moved also in a transaxillary and percutaneous access
in the area. What we learned from the tanvis group of Hamburg is that the best spot to puncture the artery is the first segment, so the segment within the clavicula and the pectoralis minor. And to do so it is mandatory to use an echoguidance
during the procedure. Here you can see how nicely you can evaluate your axillary artery and avoid puncture the artery through the pectoralis minor where there are nerves and collaterals and also collaterals of the vein. Here is short video you can see I'm puncturing
the axillary artery just below the clavicula with a short guide wire, we introduce 6 French sheath and then we place two proglides according to the instruction for use of the device for the femoral artery. And at the end we usually put a 9 French short sheet
and then we start the procedure. As soon as we are finished with the main body of the, finished with the graft and we have bridged all the vessels from below, we downsize the femoral access but we keep in one groin a 7 French sheath
in order to perform then the final closure. What we do as soon as we are finished the complete procedure we snare a wire from the femoral artery we push the seven French sheath in the axillary artery, we pull back the 12 French sheath in the axillary artery and then we are ready to unlink the two sheath
and so we push a wire in the axillary, from the axillary in the aorta, and one wire in the arm. So that we can deploy a balloon which is sized according to the axillary artery diameter we inflate the balloon and we remove the 12 French sheath and now it is possible to tie the knot of the proglide
over the balloon without any worry to have bleeding and we check with the wire then we remove the wire and then we tie the know of the proglide again. And we ensure that there is no defect and leaking on this region. We have done so far 50 cases and they are
enrolled in this study which is almost completed. And here you can see the results. We have mainly punctured the left side of the axillary, you can see that nicely the diameter of the axillary artery in this region is 8.9 millimeter the sheath size was mainly the 12 French
but we also use sometime the 16 in cases which on iliac was not available. And we also punctured the artery if there was a pacemaker or previous scar for cardiac operation. And here are the results you can see we had no open conversion, the technical success
was 92% of the cases because we are to deploy three cover stent to achieve complete sealing and one bare stent to treat dissection distally to the puncture site. We didn't have any false aneurysm on the follow up and arterial thrombosis and no nerve injuries
in the follow up. So for the discussion, if you look on the research where there are different approach in the discussion is called either to go for the first or the third segment we believe that the first segment is better because it is bigger, is more proximal
and there are no nerves in this region. And by proximalizing the approach you can also work from the right side of your patient so you don't need the guy left side of the table. Moreover, by having the 12 and the standard 19 seven french sheath you can enhance your pushability
here you can see that the 12 french sheath arrives close to the branch of renal artery and the seven french sheath is well within the renal branch. And here you can see where the hands of the operator are. Of course if you enhance this technique you can downsize contra arterial femoral sheath
needed to reach three vessels so maybe lowering your risk of limb ischemia and paraplegia and if you insert this approach in the femoral percutaneous approach, you can see that you can cut down your procedural time your OR occupation time and also
the need of post operative transfusion. So dear chairman and colleagues in conclusion, in our experience the first segment is the way to go. Echo guided puncture is mandatory. Balloon assisted removal is the safest way to do it. Our results prove that it's feasible and safe.
There are different potential advantages over branchial and cutdown. And we hope to collect more data to have more robust data to support this approach. Thank you.
- 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.
- So I'm going to talk a little bit how to diagnose to optimize results in treating ED patients. I have nothing to disclose. What is erectile dysfunction? It is defined as the inability to achieve or maintain penile erection for satisfying sexual intercourse. The best tool we have to assess and diagnosis
it is the International Index of Erectile Dysfunction, which is a questionnaire, consisting of 15 questions, and a cut-off of 21 points was shown to be very sensitive to differentiate healthy individuals from patients suffering from erectile dysfunction. What the is the aetiology of erectile dysfunction?
We see here about 40% of patients suffer from a vascular problem, leading to erectile dysfunction. Whereas the other 50-60% of patients show multiple reasons for erectile dysfunction. So not surprisingly up to 50% of patients do show a suboptimal response to PDE-inhibitors Viagra therapy.
What is the pathophysiology of erectile dysfunction, coronary artery disease, and peripheral artery disease? They all show the common cardiovascular risk factors as we know them, and not surprisingly, erectile dysfunction was shown in studies to be an independent predictor of PAD and CAD
especially in the young male. And it was also shown that increasing severity of ED was associated with an increasing prevalence of peripheral artery disease. So in ED patients, screening, prevention, and therapy of cardiovascular risk factors and diseases
is very important. Here an algorithm I want to show with you or discuss with you a little bit more in detail. So if we have an individual with suspected ED, based on the IIEF questionnaire, the first thing we need to differentiate,
does this man suffer from a psychological ED problem, or from a functional ED problem? This can be answered by questions like does the patient have nocturnal erections that can also be objectively assessed. And once we think that the patient suffers
from functional ED, because he doesn't have any erections, then we need to differentiate, does he have an arterial underlying problem or a venous underlying problem? For that purpose, we can perform ultrasound examination. I will show you that in my next slide in more detail.
And pathologic or (mumbles) for an arterial problem is low systolic velocities, lower than 30 cm/sec and also a lowered resistance index, smaller than 0.8. There is a high end-diastolic velocity, may be an indication for venous underlying problem. So once we think we have a venous problem,
we can confirm venous leakage by dynamic cavernosometry or cavernosonography. And once we have identified the leaking vein this can be embolized or surgically ligated. If we think we have an arterial underlying problem we usually perform a CTA or MR.
This to differentiate from micro and macroangiopathy. Microangiopathy is every underlying arterial problem distal to the pudendal artery, leading to ED. And if we have a macroangiopathy, but only the macroangiopathy, PTA can be considered. So ultrasound examination, how is that performed?
We inject prostaglandins into the corpora cavernosa and then the penile artery is examined by ultrasound. Here is the flow pattern. So this is the end-diastolic. We need to assess the RR and the peak systolic velocities. So ultrasound is very important to rule out
an underlying venous leakage. But even if we have identified a patient with arterial ED problems, we are not at the end yet. We have studies from POBA studies and there was shown that we deal very frequently with the problem of recoil leading to re-stenosis, but also drug-eluding stents
were associated with patency rates of only 50-70% at six months. So over 40% of patients do not benefit after PTA at all. And this may be because up to 80% we think of patients presenting with functional ED do not suffer only from an isolated arterial,
but also from a venogenic problem. In summary, ED is frequently a vascular cause. ED is an important marker of cardiovascular diseases and proper anamnesis and non-invasive workup are very important to exclude ED from other causes, and especially concomittant venous leakage.
Thank you very much.
- This talk is a brief one about what I think is an entity that we need to be aware of because we see some. They're not AVMs obviously, they're acquired, but it nevertheless represents an entity which we've seen. We know the transvenous treatment of AVMs is a major advance in safety and efficacy.
And we know that the venous approach is indeed very, very favorable. This talk relates to some lesions, which we are successful in treating as a venous approach, but ultimately proved to be,
as I will show you in considerable experience now, I think that venous thrombosis and venous inflammatory disease result in acquired arteriovenous connections, we call them AVMs, but they're not. This patient, for example,
presented with extensive lower extremity swelling after an episode of DVT. And you can see the shunting there in the left lower extremity. Here we go in a later arterial phase. This lesion we found,
as others, is best treated. By the way, that was his original episode of DVT with occlusion. Was treated with stenting and restoration of flow and the elimination of the AVM.
So, compression of the lesion in the venous wall, which is actually interesting because in the type perivenous predominant lesions, those are actually lesions in the vein wall. So these in a form, or in a way, assimilate the AVMs that occur in the venous wall.
Another man, a 53-year-old gentleman with leg swelling after an episode of DVT, we can see the extensive filling via these collaterals, and these are inflammatory collaterals in the vein wall. This is another man with a prior episode of DVT. See his extensive anterior pelvic collaterals,
and he was treated with stenting and success. A recent case, that Dr. Resnick and I had, I was called with a gentleman said he had an AVM. And we can see that the arteriogram sent to me showed arterial venous shunting.
Well, what was interesting here was that the history had not been obtained of a prior total knee replacement. And he gave a very clear an unequivocal history of a DVT of sudden onset. And you can see the collaterals there
in the adjacent femoral popliteal vein. And there it is filling. So treatment here was venous stenting of the lesion and of the underlying stenosis. We tried an episode of angioplasty,
but ultimately successful. Swelling went down and so what you have is really a post-inflammatory DVT. Our other vast experience, I would say, are the so-called uterine AVMs. These are referred to as AVMs,
but these are clearly understood to be acquired, related to placental persistence and the connections between artery and veins in the uterus, which occurs, a part of normal pregnancy. These are best treated either with arterial embolization, which has been less successful,
but in some cases, with venous injection in venous thrombosis with coils or alcohol. There's a subset I believe of some of our pelvic AVMs, that have histories of DVT. I believe they're silent. I think the consistency of this lesion
that I'm showing you here, that if we all know, can be treated by coil embolization indicates to me that at least some, especially in patients in advanced stage are related to DVT. This is a 56-year-old, who had a known history of prostate cancer
and post-operative DVT and a very classic looking AVM, which we then treated with coil embolization. And we're able to cure, but no question in my mind at least based on the history and on the age, that this was post-phlebitic.
And I think some of these, and I think Wayne would agree with me, some of these are probably silent internal iliac venous thromboses, which we know can occur, which we know can produce pulmonary embolism.
And that's the curative final arteriogram. Other lesions such as this, I believe are related, at least some, although we don't have an antecedent history to the development of DVT, and again of course,
treated by the venous approach with cure. And then finally, some of the more problematic ones, another 56-year-old man with a history of prior iliofemoral DVT. Suddenly was fine, had been treated with heparin and anticoagulation.
And suddenly appeared with rapid onset of right lower extremity swelling and pain. So you see here that on an arteriogram of the right femoral, as well as, the super selective catheterization of some of these collaterals.
We can see the lesion itself. I think it's a nice demonstration of lesion. Under any other circumstance, this is an AVM. It is an AVM, but we know it to be acquired because he had no such swelling. This was treated in the only way I knew how to treat
with stenting of the vein. We placed a stent. That's a ballon expanded in the angiogram on your right is after with ballon inflation. And you can see the effect that the stenting pressure, and therefore subsequently occlusion of the compression,
and occlusion of the collaterals, and connections in the vein wall. He subsequently became asymptomatic. We had unfortunately had to stent extensively in the common femoral vein but he had an excellent result.
So I think pelvic AVMs are very similar in location and appearance. We've had 13 cases. Some with a positive history of DVT. I believe many are acquired post-DVT, and the treatment is the same venous coiling and or stent.
Wayne has seen some that are remarkable. Remember Wayne we saw at your place? A guy was in massive heart failure and clearly a DVT-related. So these are some of the cases we've seen
and I think it's noteworthy to keep in mind, that we still don't know everything there is to know about AVMs. Some AVMs are acquired, for example, pelvic post-DVT, and of course all uterine AVMs. Thanks very much.
(audience applause) - [Narrator] That's a very interesting hypothesis with a pelvic AVMs which are consistently looking similar. - [Robert] In the same place right? - [Narrator] All of them are appearing at an older age. - [Robert] Yep.
Yep. - This would be a very, very good explanation for that. I've never thought about that. - Yeah I think-- - I think this is very interesting. - [Robert] And remember, exactly.
And I remember that internal iliac DVT is always a silent process, and that you have this consistency, that I find very striking. - [Woman] So what do you think the mechanism is? The hypervascularity looked like it was primarily
arterial fluffy vessels. - [Robert] No, no, no it's in the vein wall. If you look closely, the arteriovenous connections and the hypervascularity, it's in the vein wall. The lesion is the vein wall,
it's the inflammatory vein. You remember Tony, that the thing that I always think of is how we used to do plain old ballon angioplasty in the SFA. And afterwards we'd get this
florid venous filling sometimes, not every case. And that's the very tight anatomic connection between those two. That's what I think is happening. Wayne? - [Wayne] This amount is almost always been here.
We just haven't recognized it. What has been recognized is dural fistula-- - Yep. - That we know and that's been documented. Chuck Kerber, wrote the first paper in '73 about the microvascular circulation
in the dural surface of the dural fistula, and it's related to venous thrombosis and mastoiditis and trauma. And then as the healing process occurs, you have neovascular stimulation and fistulization in that dural reflection,
which is a vein wall. And the same process happens here with a DVT with the healing, the recanalization, inflammation, neovascular stimulation, and the development of fistulas. increased vascular flow into the lumen
of the thrombosed area. So it's a neovascular stimulation phenomenon, that results in the vein wall developing fistula very identical to what happens in the head with dural fistula had nothing described of in the periphery.
- [Narrator] Okay, very interesting hypothesis.
- Thank you, Doctor Chuter. So, as you saw in Eric's presentation, really indwelling catheters and wires have become more or less routine for us. And they're nothing new to this era of complex and vascular repair. We've seen them a long time and
we started using them, of course, for iliac branch devices, as you can see here. And the concept is the same when you use them for other branches or fenestrations, as I'll show you. And here, an iliac branch is coming over with that indwelling catheter and snaring
from the contralateral end to be able to get that sheath. This is a helical-helical device, so putting that sheath over to get access to the contralateral side. So why and when do we need preloaded grafts with wires or catheters for complex aortic repair? Well, sometimes we have access issues
and it alleviates that, as I'll show you. Having the fenestrations or branches pre-catheterized will intuitively reduce X-ray exposure times and operating times, and also help catheterization in difficult anatomy, as Eric alluded to, and thereby
keeping the procedure down and avoiding large sheaths in both groins, at the same time minimizing lower-extremity ischemia time. This is an example of putting a fenestrated device in a previous infrarenal device. And the multitude of markers here
makes it very difficult to actually locate the fenestrations on the new graft, so it's very advantageous in these settings to have the fenestrations preloaded. This was first described by Krassi Ivancev back in 2010, and this is the original
preloaded design for a juxtarenal fenestrated device. And you can see a loop wire going through the top of that device. And a very simple handle with a couple of wires and things coming out of it, and some technical difficulties with wire catches
and other things made us move away from that design. It was later evolved into this bi-port delivery system, which allows you to have access to two fenestrations from a unilateral approach with indwelling renal wires and then sheaths, and having
those wires go through the renal fenestrations. And this evolved into the p-branch off-the-shelf fenestrated device from Cook, as you can see here. And you can see that loop wire coming out through that right renal fenestration
going through the top of the graft. And this is the catheter just describing how you then can use a double-puncture technique to access that renal artery and place the sheath there. The advantages of the technique
was described by Doctor Torsello's group in Munster here, showing that it does in fact reduce the amount of radiation in contrast during these procedures as well as bringing the procedure time down. And this was described by Mark Farber as well
in the experience of the off-the-shelf p-branch devices. We modified the preloaded device a little bit further by taking away that very top stent, and instead of having the loop wire is on the p-branch, just placing catheters through those fenestrations,
but still using the triport handle, and then replacing those with 018 wires to achieve stable positions. Of course, preloaded catheters and wires can then be used for branch procedures as well, as Eric Verhoeven just showed you. And in this case, just using these
indwelling catheters to allowing wires to be snared from above and then advanced into the specific branches and distal arteries. And of course, if you use a fenestrated device for thoraco-abdominal repair, the same applies. And this is from Carlos Timaran's paper
just showing how he places these wires from above in these discrete fenestrations. This is a combined device of a two-branch, two-fen device, if you would like, that has indwelling wires going through the fenestrations and out
through the branches, which we use on occasion. You can then bring that out through the axillary artery, and you get access directly from above to the branches from below for the fenestrations. And we found it very useful in the setting of narrow aortic
lumens and chronic aortic dissections, as in this case. And you can see here, then, on the wires placing the sheath, catheterizing the renals, and then at the same time, having these access catheters in the branches so you don't have to access those for a nice end result.
So in summary, Chairman, ladies and gentlemen, preloaded wire I think reduces the operative time and the X-ray exposure during these procedures. It's very useful, particularly in complex torturous aortas, during redo EVAR cases with preexisting devices, and
compromised iliac access, and in the situations of narrow aortas, like in chronic aortic dissections. Thank you very much.
- Good afternoon, everybody. I think it's not uncommon for the vascular specialist to see a patient such as this with acute limb ischemia. And acute limb ischemia typically occurs commonly in a vascular unit. And the truth is of natural history is that the amputation rates are high whether or not
you intervene in them or not. The mortality though, is extraordinarily high compared to certainly chronic peripheral arterial disease, and even many cancers. Now, the etiology of acute limb ischemia is most commonly caused either by thrombosis or embolism,
and the goals of treatment, as you've heard in this session, are to restore perfusion to the extremity, to identify and correct underlying lesions if they exist, anticipate and treat reperfusion, and identify and correct embolic sources, if they are present.
Of course, there are two revascularization strategies, endovascular and surgical, and you heard a little bit about these. A recent evidence summary analysis looked at almost 3,000 articles. 563 abstracts read, 68 articles fully reviewed,
six randomized trials, and this is the business table that I'm going to translate to you here. So essentially, with all the literature out there, the composite 30 day mortality was higher with open surgery compared to endovascular therapy. There were similar short-term survival rates.
There were similar one year limb salvage rates, and the vascular therapy may reduce the need for open surgery, and this was shown in several randomized trials. Endovascular therapy is associated with more bleeding, and open surgery of course,
has the risk of surgical complications. And given all this data, and the debates that you've heard, the census is that given relative equivalence, endovascular therapy should be used as initial treatment of acute limb ischemia, unless there's obvious contraindication to that.
I want to focus a little bit about thromboembolism, and particularly, embolectomy that is commonly used to treat this problem. It's not uncommon to see such patients. I actually saw two such patients last week when I was on call.
Patients that come in with acute limb ischemia, caused by embolus. And of course, one way to treat this tried and true is using a surgical embolectomy using a variety of Fogarty catheters that are available. What we wanted to do is take a look at
the current state of affairs for results of treatment of these patients. We wanted to determine perioperative morbidity and develop a risk prediction model for postoperative mortality after lower extremity embolectomy.
And we did that by looking at the NSQIP database over a course of almost 10 years. We looked at emergent, unilateral, lower extremity embolectomy, and we excluded those patients who had either chronic ischemia,
bilateral embolectomy that suggested an aortic component, non-emergent cases, or patients who required a concurrent bypass. We had almost 2,000 patients in our cohort. Mean age was 68, and 48% were male. These comorbidities and demographics are
what you would expect to see in this patient cohort. Please note that a significant number of these patients, again, no big surprise, are functionally dependent. In terms of procedural details, 70% required an iliofemoral embolectomy for the groin. 17% required a popliteal embolectomy.
12% required a multilevel procedure, and almost 20% of patients required concurrent fasciotomies. In terms of 30 day outcomes of this patient cohort, 5% had MI or cardiac arrest. 16% had pulmonary complications. 8% had wound complications.
26% had to return to the operating room, and the mortality rate, 14% was quite high. In terms of resource utilization, these patients tended to stay in the hospital for a long time. 10 days on the average, and readmission rates were high. And so, when we looked at independent predictors of
30 day mortality, we found that functional dependence, chronic renal failure, steroid use, older age, recent MI or angina, and congestive heart failure and male gender significantly and independently effected mortality. Please note that functional dependence
and chronic renal failure had a significant effect, given their very high odds ratios. We then took these characteristics and constructed a risk prediction model where we then assigned points to the various characteristics.
And this model had a C statistics of .8, and basically, you can use this model to predict mortality. So, if a patient had more than 11 points, then the mortality is more than 50%. In conclusion, emergent lower extremity embolectomy has high morbidity, mortality and resource utilization.
In patients with acute limb ischemia requiring embolectomy, among other factors, functional dependence and chronic renal failure are highly associated with increased perioperative mortality. And our scoring system can help inform consent process and alternative treatment decisions
such as providing palliative care to this complex patient population. Thank you.
- Thank you very much for the nice introduction for the privilege to start the aortic session with this nice, very interesting topic about Chimney technique and especially about the in-vitro testing which we have done in Muenster in Germany. So, the Chimney endovascular technique we treat short necks as we see here.
With the use of off-the-shelf devices and the placement is in parallel and outside configuration of the main abdominal device. Well, if you see the literature we can see enthusiastic reports with the use of these alternative therapeutic options,
showing low incidence of endo leaks, excellent patency, and durability of these endovascular solutions. On the other side we have also centers with suboptimal experience, as we see here from Manchester, in the titled already publication,
late ruptures after single chimneys or from the group from Florida, highlight that the technique raises cause for concern. So what are the reasons for these divergent experience? Could be the heterogeneity of the used materials, but also the degree of oversizing
of the aortic stent graft? In order to evaluate that, we performed first of all a chimney case of a patient with a huge paraanastomotic aneurysm which we did with single chimney for the right renal artery, as we see here.
What we have done is the CT scan of these patients, we send to a special company and create this silicone model one by one with the anatomy of this treated case, as we see here, having a diameter of 28 millimeter, exact the anatomy of the renals,
of the neck length, infrarenally. And it was also really nice the opportunity to have a fluid simulation system, and we can have also the possibility to bring the device in the CT scan, and perform CT angiography, as we can see here,
very nicely the pictail catheter into the descending aorta, and evaluating now the impact of the different devices for this technique. Here is the example with the device you see here how we deploy the chimney graft, here is an Incraft stent graft for the right renal artery.
The first attempt was to evaluate the impact of different abdominal devices. If we use the same chimney graft in this particular case, the Icast for Advanta V12, and you see what we changed was only the type of the stent graft of the aorta.
If you see here the CT scan analysis, you see very nicely these combination of a mitral endoskeleton of the enduring device with a rigid, but very good, intraradial force Advanta V12, or Icast. You can see here how nicely performs
around the chimney graft. And if we see also in the reconstruction, we have a very nice expansion of the chimney graft, especially in the proximal edge, which is very important in order to have a good patency over the time.
You see here very nicely the expansion of the proximal edge of the balloon expandable covered stent Let's see now what happened with the Incraft. Again, you see here very nice the radial force of the Icast is here very nice to see. However, we have seen a completely different behavior
of the abdominal stent graft of this company. You see here that we have potentially more gutters compared to the other conformability of the endurant around the chimney graft. So it was a very nice sign and finding and showing the impact of the abdominal stent graft
for this technique. What we have done after that was we took the endurant device and we changed now the use of the chimney graft, so we used in the first attempt the self-expanding covered stents, the Viabahn,
versus a balloon expandable covered stent like the Begraft. And if you see here the results, you see again a very nice expansion of the endurant around the chimney graft, but in the reconstruction you see here the severe compression of the Viabahn self-expanding stent
has poor radial force despite that we lined we had per se 70 percent stenosis. I think it's a very important finding crucial compared to the balloon expandable chimney grafts you see here the Begraft, they had also a very good expansion
as balloon-expandable covered did, but also we see here completely different area of gutters if we compare the two balloon expandable covered stents in the anterior and posterior phase, you see here the Begraft plus seems to perform better. The impact of degree of oversizing we know
from the work of Riambaud 30 percent is the recommendation if you see this very nice analysis, you see here with 15 percent oversizing, we have this area of gutter versus 30 percent of oversizing you see a very nice conformability around the chimney that we chose how important is for this technique
to have enough fabric material to wrap up the chimney grafts. In conclusion, ladies and gentlemen, we have seen in this very nice in-vitro testing that indeed the area of the gutters vary depending on the different device combinations.
And also we have seen how important is the appropriate device selection, and 30 percent oversizing to obtain optimal results. Thank you very much.
- Thank you Mr. Chairman. Ladies and gentleman, first of all, I would like to thank Dr. Veith for the honor of the podium. Fenestrated and branched stent graft are becoming a widespread use in the treatment of thoracoabdominal
and pararenal aortic aneurysms. Nevertheless, the risk of reinterventions during the follow-up of these procedures is not negligible. The Mayo Clinic group has recently proposed this classification for endoleaks
after FEVAR and BEVAR, that takes into account all the potential sources of aneurysm sac reperfusion after stent graft implant. If we look at the published data, the reported reintervention rate ranges between three and 25% of cases.
So this is still an open issue. We started our experience with fenestrated and branched stent grafts in January 2016, with 29 patients treated so far, for thoracoabdominal and pararenal/juxtarenal aortic aneurysms. We report an elective mortality rate of 7.7%.
That is significantly higher in urgent settings. We had two cases of transient paraparesis and both of them recovered, and two cases of complete paraplegia after urgent procedures, and both of them died. This is the surveillance protocol we applied
to the 25 patients that survived the first operation. As you can see here, we used to do a CT scan prior to discharge, and then again at three and 12 months after the intervention, and yearly thereafter, and according to our experience
there is no room for ultrasound examination in the follow-up of these procedures. We report five reinterventions according for 20% of cases. All of them were due to endoleaks and were fixed with bridging stent relining,
or embolization in case of type II, with no complications, no mortality. I'm going to show you a couple of cases from our series. A 66 years old man, a very complex surgical history. In 2005 he underwent open repair of descending thoracic aneurysm.
In 2009, a surgical debranching of visceral vessels followed by TEVAR for a type III thoracoabdominal aortic aneurysms. In 2016, the implant of a tube fenestrated stent-graft to fix a distal type I endoleak. And two years later the patient was readmitted
for a type II endoleak with aneurysm growth of more than one centimeter. This is the preoperative CT scan, and you see now the type II endoleak that comes from a left gastric artery that independently arises from the aneurysm sac.
This is the endoleak route that starts from a branch of the hepatic artery with retrograde flow into the left gastric artery, and then into the aneurysm sac. We approached this case from below through the fenestration for the SMA and the celiac trunk,
and here on the left side you see the superselective catheterization of the branch of the hepatic artery, and on the right side the microcatheter that has reached the nidus of the endoleak. We then embolized with onyx the endoleak
and the feeding vessel, and this is the nice final result in two different angiographic projections. Another case, a 76 years old man. In 2008, open repair for a AAA and right common iliac aneurysm.
Eight years later, the implant of a T-branch stent graft for a recurrent type IV thoracoabdominal aneurysm. And one year later, the patient was admitted again for a type IIIc endoleak, plus aneurysm of the left common iliac artery. This is the CT scan of this patient.
You will see here the endoleak at the level of the left renal branch here, and the aneurysm of the left common iliac just below the stent graft. We first treated the iliac aneurysm implanting an iliac branched device on the left side,
so preserving the left hypogastric artery. And in the same operation, from a bowl, we catheterized the left renal branch and fixed the endoleak that you see on the left side, with a total stent relining, with a nice final result on the right side.
And this is the CT scan follow-up one year after the reintervention. No endoleak at the level of the left renal branch, and nice exclusion of the left common iliac aneurysm. In conclusion, ladies and gentlemen, the risk of type I endoleak after FEVAR and BEVAR
is very low when the repair is planning with an adequate proximal sealing zone as we heard before from Professor Verhoeven. Much of reinterventions are due to type II and III endoleaks that can be treated by embolization or stent reinforcement. Last, but not least, the strict follow-up program
with CT scan is of paramount importance after these procedures. I thank you very much for your attention.
- Thank you very much Frank and thanks for the invitation. My first thing is to deal with the patient who's awaiting CABG who's had a previous stroke or TIA. This is the only study of it's kind showing that if you proceed with isolated CABG, the risk of stroke is extremely high and if you look at the meta-analysis that we've done of whether you do endarterectomy or
stenting in symptomatic patients, this is all the literature there is. And what you can clearly see is that the death and stroke rates in patients undergoing CAS followed by CABG are much higher than after carotid and endarterectomy. And that lead us to recommend that a stage of
synchronous carotid intervention should be considered in CABG patients with a history of stroke or TIA and who have a 50 to 99% stenosis. But advise that for now, if you're going to do that such an intervention, surgery should probably be considered instead of stenting.
But 96% of all interventions of the CABG and carotid variety are in asymptomatic patients, so what about them? Well, this is all the literature there is on stroke risk in patients undergoing isolated CABG with a unilateral asymptomatic stenosis of 70 to 99 or 80 to 99 and you can see there is an awful lot of zeroes
in that table and if you go at patients with bilateral significant disease, the death and stroke rate is much higher but again there is not too many strokes here. And if you look critically at the literature and ask yourself okay we've had so many strokes, how many of them can be attributable to underlying
carotid disease by looking at the CT scans or the distribution of lesions, you'll see that between 85 and 95% of all strokes cannot be attributed to an underlying significant carotid stenosis. And if you look at all the death and stroke rates and this is a multiple meta-analysis that our
group have done over the last 15 years, these are the death and stroke rates depending on how you treat the patients, and 80% of these are asymptomatic and 80% have got unilateral stenosis and the death and stroke rates are far in excess of the risk of stroke if you just perform an
isolated CABG in patients with unilateral asymptomatic disease. There have been two randomized trials. This is one, the Iluminati trial that Jean-Baptiste was involved in, 30-day death and stroke rates not significantly different.
There is quite an astonishing trial from Germany, which was again unilaterally asymptomatic stenosis with a near 20% death and stroke rate with synchronous carotid CABG and a 10% definite stroke rate with medical therapy, ah isolated CABG, sorry. So the ESVS have advised that a staged synchronous
carotid intervention is not recommended in CABG patients with an asymptomatic unilateral, 70 to 99% stenosis for preventing stroke after CABG. A staged synchronous intervention may be considered in patients with bilateral disease, the evidence is not brilliant but it's such a rare thing that it's
probably not worth arguing about. Now what about patients who are undergoing non-cardiac surgery? This is quite an interesting group, because if say, a gastrectomy, a hip replacement or whatever, if they've had a previous history of stroke or TIA
they should undergo carotid imaging and if they've got a significant stenosis they should undergo prior carotid revascularization prior to undergoing their gastrectomy et cetera. But what about the asymptomatic patient? This is quite interesting.
First of all, let's just look at a very large study by Jorgensen, 4 nearly 500,000 elective non-cardiac operations and 7,000 had suffered a prior stroke or TIA, and the most important thing was, the stroke risk was directly related to the time from the onset of the TIA to doing the operation.
So if you did it within three months of the stroke or TIA there was a 12% peri-operative stroke rate, but if you managed to get out to six months, the stroke rate was only 0.1% so the lesson learned there is that if it's possible to delay surgery in patients who've had a prior stroke or TIA
or a recent one, you should delay it for six months. Only two studies have looked at whether asymptomatic carotid stenosis increased the stroke risk in patients undergoing non-cardiac operations. Ballotta did a randomized trial, and Sonny, which is a very large observational study,
looked at the impact of asymptomatic carotid stenosis on outcome and found that there was no evidence that a pre-existing carotid stenosis increased the risk of stroke in patients undergoing major non-cardiac surgery. Similarly, in a huge study on TAVI patients,
no evidence that carotid disease was a risk factor for perioperative stroke. So in our recommendations we advised routine carotid imaging in asymptomatic patients undergoing major non-cardiac surgery is not recommended and prophylactics and arterial stenting is not
recommended in patients with asymptomatic carotid stenoses undergoing non-cardiac/vascular procedures. And if you'd like to look at all the literature and data that we came to in using to our conclusions, the guidelines are free to access on the internet.
Thank you very much.
- I'd like to share with you our experience using tools to improve outcomes. These are my disclosures. So first of all we need to define the anatomy well using CTA and MRA and with using multiple reformats and 3D reconstructions. So then we can use 3D fusion with a DSA or with a flouro
or in this case as I showed in my presentation before you can use a DSA fused with a CT phase, they were required before. And also you can use the Integrated Registration like this, when you can use very helpful for the RF wire
because you can see where the RF wire starts and the snare ends. We can also use this for the arterial system. I can see a high grade stenosis in the Common iliac and you can use the 3D to define for your 3D roadmapping you can use on the table,
or you can use two methods to define the artery. Usually you can use the yellow outline to define the anatomy or the green to define the center. And then it's a simple case, 50 minutes, 50 minutes of ccs of contrast,
very simple, straightforward. Another everybody knows about the you know we can use a small amount of contrast to define the whole anatomy of one leg. However one thing that is relatively new is to use a 3D
in order to map, to show you the way out so you can do in this case here multiple segmental synosis, the drug-eluting-balloon angioplasty using the 3D roadmap as a reference. Also about this case using radial fre--
radial access to peripheral. Using a fusion of image you can see the outline of the artery. You can see where the high grade stenosis is with a minimum amount of contrast. You only use contrast when you are about
to do your angiogram or your angioplasty and after. And that but all everything else you use only the guide wires and cathers are advanced only used in image guidance without any contrast at all. We also been doing as I showed before the simultaneous injection.
So here I have two catheters, one coming from above, one coming from below to define this intravenous occlusion. Very helpful during through the and after the 3D it can be helpful. Like in this case when you can see this orange line is where
the RF wire is going to be advanced. As you can see the breathing, during the breathing cycle the pleura is on the way of the RF wire track. Pretty dangerous stuff. So this case what we did we asked the anesthesiologist
to have the patient in respiratory breath holding inspiration. We're able to hyperextend the lungs, cross with the RF wire without any complication. So very useful. And also you can use this outline yellow lines here
to define anatomy can help you to define where you need to put the stents. Make sure you're covering everything and having better outcomes at the end of the case without overexposure of radiation. And also at the end you can use the same volt of metric
reconstruction to check where you are, to placement of the stent and if you'd covered all the lesion that you had. The Cone beam CT can be used for also for the 3D model fusion. As you can see that you can use in it with fluoro as I
mentioned before you can do the three views in order to make sure that the vessels are aligned. And those are they follow when you rotate the table. And then you can have a pretty good outcome at the end of the day at of the case. In that case that potentially could be very catastrophic
close to the Supra aortic vessels. What about this case of a very dramatic, symptomatic varicose veins. We didn't know and didn't even know where to start in this case. We're trying to find our way through here trying to
understand what we needed to do. I thought we need to recanalize this with this. Did a 3D recan-- a spin and we saw ours totally off. This is the RFY totally interior and the snare as a target was posterior in the ASGUS.
Totally different, different plans. Eventually we found where we needed to be. We fused with the CAT scan, CT phase before, found the right spot and then were able to use
Integrated registration for the careful recanalization above the strip-- interiorly from the Supraaortic vessels. As you can see that's the beginning, that's the end. And also these was important to show us where we working.
We working a very small space between the sternal and the Supraaortic vessels using the RF wire. And this the only technology would allowed us to do this type of thing. Basically we created a percutaneous in the vascular stent bypass graft.
You can you see you use a curved RF wire to be able to go back to the snare. And that once we snare out is just conventional angioplasty recanalized with covered stents and pretty good outcome. On a year and a half follow-up remarkable improvement in this patient's symptoms.
Another patient with a large graft in the large swelling thigh, maybe graft on the right thigh with associated occlusion of the iliac veins and inclusion of the IVC and occlusion of the filter. So we did here is that we fused the maps of the arterial
phase and the venous phase and then we reconstruct in a 3D model. And doing that we're able to really understand the beginning of the problem and the end of the problem above the filter and the correlation with the arteries. So as you can see,
the these was very tortuous segments. We need to cross with the RF wire close to the iliac veins and then to the External iliac artery close to the Common iliac artery. But eventually we were able to help find a track. Very successfully,
very safe and then it's just convention technique. We reconstructed with covered stents. This is predisposed, pretty good outcome. As you can see this is the CT before, that's the CT after the swelling's totally gone
and the stents are widely open. So in conclusion these techniques can help a reduction of radiation exposure, volume of contrast media, lower complication, lower procedure time.
In other words can offer higher value in patient care. Thank you.
- Morning, thank you very much, Mark and Frank, thank you. Here's my disclosures. So, access to the ascending aorta and aortic arch can be complex when people have had a lot of other procedures done previously. There's several different options, and what I'm going to present to you today
was a unique option that we had to undertake with a given patient when these other options weren't possible. So, upper extremity or neck access is an option from an axial subclavian standpoint, or even, potentially, from a carotid artery.
We have a fair bit of experience at our institution using axillary access. This shows a patient that needed a descending thoracic graft that had an occluded distal aorta that we went through a right axillary approach, and you can
place a large sheath. And as well for a lot of the off label approaches that we use for complex visceral anatomy we're able to do this through an axillary approach, and here you see four sheaths. This doesn't always get you what you need, though,
for the entire ascending or the arch in combination, it only lets you do a portion of that. Central access is feasible, as well. Sternotomy with and ascending conduit can also be done with a mini anterior thoracotomy with and ascending conduit. Here is a patient that had an arch debranching
through an open sternotomy approach with a sheath then placed in an antigrade fashion, in order to place devices down to the level of zone zero. This was an older case, and something that we don't do as often now, but was an option in this patient.
Another option is transapical. Here you see the way this is done, obviously from the Tavr experience, this has gained people's confidence in doing it this way, but you still have to cross the valve,
and in patients who have had a valve replacement, that is probably not something that you'd like to do with a large device. Here's an example of that. This was given to me by my friend Brad Leshnower, just so you can see, device coming through a
transapical approach, a pigtail catheter from a femoral approach, and able to get a device into the ascending aorta. So what if? This is a scenario that we faced. A patient that had good iliac access,
it wasn't trouble getting a device through tortuous or too small vessels, but had a prior ascending reconstruction that was really tortuous, redo surgery for a sternotomy, and had a valve replacement, as well. We actually originally tried the Body Floss technique,
which I'll show you, but I could not get the device to advance to where I needed it to be. Here's what the anatomy looked like. This is a chronic aortic dissection with aneurysmal degeneration. Here you see the prior ascending repair,
slightly more magnified view, with some of the difficulties you could see, to navigate this anatomy. This was the body floss with the wire through the right axillary. And here you can see what that looks like
with the pigtail catheter coming through, with the wire through and through, but we could not navigate the device all the way across and into the ascending where I needed it to be for a proximal landing. So what now?
Well, I'll have to give credit to one of my interventional cardiology colleagues. We're fortunate that at our institution we have a very collaborative environment, and I knew that some of his expertise with the transapical approach.
Here is just video from him, for a technique that they use for peri-valvular leak after someone's had a prior open valve repair, that's not a candidate for Tavr, that they go in through a transapical fashion
and use occluder devices to shut down that leak. This is the technique that's utilized with a combination of echo, ultrasound, and as well coronary angiography, but this shows you the windows that you're looking for, and the puncture spot that would be
possible to safely puncture in a percutaneous fashion the apex of the heart. This shows you what's done during that procedure. It's marked with a hemostat. Coronary angiography is done to identify the LAD, so you don't accidentally puncture the LAD.
That is poor form. And so with this case, what we did was get wire access through and through with a sheath that you can see going into the apex. Able to now advance this device all the way down. Get it to deploy accurately at the level of
left common carotid, which was the goal. And here you can see a pretty good demonstration, I have the arrows here. The red arrow shows you the sheath, that's exiting the chest, the right arrow is showing you a wire,
held with the hemostat that's outside the body, so that I'm able to get through and through access and navigate the device all the way to where it needs to be. Again, iliac was not an issue here, this was just the ascending and arch anatomy.
The closure is then done with an Amplatz occlusion plug, which again, this is a combination of expertise, because it's something that he's done a fair bit, and these are the different devices that are available to try to close that puncture site.
So this is what the end result looked like when we were able to get the device in place and able to navigate this challenging anatomy with a combination of specialties, with different expertise, being able to do this.
So I just present this as an interesting alternative when you've run out of sort of appropriate options to be able to get a device into a challenging environment, thank you.
- BEVAR through the false lumen, it's rarely indicated. These are my disclosures. And usually, we proceed through the true lumen using BEVAR for post dissection aneurysm like in this case. From our experience, Regensburg and Nuremberg, at the moment the biggest surveys of 71 patient with post dissection aneurysm published
this year in European journal of Vascular and Endovascular Surgery. Sometimes it's necessary to go through the membrane from the true to the false lumen because of the urging of the arteries. And it was necessary in 14 out of 261
target vessels in this material. It makes about 5%. But sometimes, we have a very different cause of the chronic dissection. Like in this patient, where the true lumen shows a very big opening for the false lumen
and ends at the level of the renal arteries. And both legs are only perfused by the false lumen. So, what to do, and it was already some years ago, we decided to make a bypass from ascending to both femoral arteries and pseudoextenders use TEVAR for the aneurysm of the descending aorta.
Now, a case presentation, a 55 years old male patient with hypertension and nicotine consumption. He has had acute aortic dissection, 2014 with a true lumen collapse and dissection of superior mesenteric artery. He has had malperfusion of his intestine and right limb.
At that time, he was treated just by femoral-femoral bypass from left to the right and right hemicolectomy due to ischemic complication. Between 2014 to 2017, this dissection still started at the level of left subclavian artery. The aneurysm was progressive to 63 mm.
He has had the complete thrombosis of the thulomen at the level of the right renal artery with atrophic right kidney. He has had celiac trunk, left renal, and inferior mesenteric artery from the false lumen and dissected superior mesenteric artery.
The first procedure was in October, 2017 with the branching and the Amplatzer to the left subclavian artery to prevent retrograde flow. Branch device and uni-iliac tube because of occluded right iliac artery. After the first operation, we have seen
thrombosis of the thoracic aorta and patent segmental arteries at the level of celiac trunk. The second operation was deployment of covered stentgrafts balloon-expandable covered stentgrafts to the superior mesenteric, left renal and inferior mesenteric artery, why?
If you remember, the patient has had mesenteric dissection and only the right hemicolectomy. So we try to preserve all the collaterals to the intestine. And the third procedure, after balloon occlusion of the celiac trunk and branch, drainage, MEPS, and intrasaccular pressure measurement
was a completion of the celiac trunk with two stent grafts. Preoperative CT, a staged procedure with open aorta at the level of renal and mesenteric arteries, and then completion postoperative with all arteries perfused. Now, what we learned after this.
We may have different methodology. This patient is stable, the reconstruction is well-functioning after 12 months of follow-up, but we should always remember to tailor the procedure to the morphology, it is one of the ways. Thank you very much.
- Thank you very much for inviting me here again and I'll be talking about thermal ablation RCTs. My coauthor, Michel Perrin from Lyon, in France, the gourmet capital in the world has collected RCTs on operative treatment of CVD since 1990. Today he has 186 collected RCTs
of the which 84 involve thermal ablation. You can find all this data for free in Phlebolymphology.org. Do we need further RCTs? Well systematic reviews and meta-analyses increasingly important in evidence-based medicine. And this development is well-described
by Gurevitch in Nature this year and criticized by Ioannidis two years earlier. Common sense is a good principle when you try to understand meta-analyses. Do most studies point in the same direction?
Is the effect significant? Are the patient-related outcome measures relevant and what happens if you exclude one study? Since 2008, 10 years back, these are the available meta-analyses and the last came from Ireland earlier this year.
It was published in the JVS, endovenous and in fact this is in March. And they found nine RCTs comparing conventional surgery and endovenous therapy with five years or more follow-up that were selected. Primary outcome was recurrence rate.
There is some sole recurrence rate was that there is no significant difference in laser versus surgery, same for radioactive frequency versus surgery and radioactive frequency versus laser. They found an inferiority
of ultrasound guided foam sclerotherapy versus laser and surgery. Their conclusions were that the quality of evidence is poor therefore more trials that are well-powered to examine long-term outcomes are warranted. The new kids on the block,
steam, MOCA, and Venaseal, are not included in the meta-analyses due to lack of more than five years follow-up in their paper. Obsolete RCTs. Endovenous laser in the presented long-term RCTs
were performed by 810-980 nanometer wavelength using a bare fiber. There is a paucity of RCTs comparing open surgery with novel endovenous laser and new RF techniques. Recent criticism against endovenous ablation, is the pendulum swinging towards high ligation
and stripping again? Olle Nelzen from Sweden in an editorial in British Journal of Surgery reconsidering the endovenous revolution, wrote that neovascularization is a dominant finding following high ligation and stripping
but proximal venous stumps and incompetent anterior accessory saphenous veins are the main factor after endovenous ablation. So long-term follow-up suggests that the recurrence rate after endovenous ablation seem to increase over time. A substantial number of patients who have undergone
endovenous ablation will eventually develop symptomatic recurrence requiring repeat therapy. And such scenario would change the equation regarding patient benefit and costs making endovenous ablation less competitive and challenging current guidelines.
So summary of needs for further RCTs. Quality of present RCTs poor in several meta-analyses, no thermal endovenous technique is superior to open surgery, RCTs rapidly obsolete due to change in technology, and more trials that are well-powered to examine long-term outcomes are warranted.
So final point, apparently we need more RCTs to satisfy the quality requirements for clinically important systematic reviews and meta-analyses. And what about the clinical guidelines? Thank you very much.
- Thank you Mr. Chairman. I would like to thank Dr. Veith for the invitation. My disclosure. Severely angled neck is still a big problem, particularly for those who are unfit for open surgery. It seems to be a little bit more common in Asians. We believe that open surgery is still
the treatment of choice. However, in some patients who are with significant comorbidities and not a very good candidate for open repair. And we don't like the idea of conservative treatment, meaning that we are trying our best of doing nothing until it's ruptured.
The question is can endovascular repair be a safe, effective, and durable option for these kind of anatomies. We reviewed our experience of treating AAA patients with neck over 60 degrees in this over 9-1/2-year period. There were 154 patients with the average diameter of the AAAs of 7 cm, quite large.
And the average neck length was around almost 3 cm. This is, I think is a key factor. We use Endurant for this kind of challenging anatomy in our patients. We believe that we need longer ceiling zone up to 20 to 25 mm.
We prepare for maybe needed proximal cuff extension parallel graft, and recently available the Heli-FX in every case. And we tried to deploy our stent graft a little bit more high, as close to the renal artery as possible. But trying not to cover the renal artery itself.
We believe that adjunct procedure is very important like showing in this case the cuff extension and Heli-FX to help to treat the problem. Also with the parallel graft, either chimney, or the sandwich technique may be needed in some cases. We categorize patient into five groups according
to their angle, their neck angles. Almost 3/3, uh, 3/4 of the cases are over 75 degrees angled neck. As some, a few example of the cases, this one of the early case that we treated up to 4 cm long neck. As you can see a good result, up to 8 years,
no migration, no endoleak. And our example of a little bit shorter neck, up to five years aneurysm shrunk, no migration, no endoleak. Another little twisted neck also good result, two years, aneurysm shrunk, no migration, no endoleak. We achieved 95% technical success and 2.6% 30-day mortality
rate and with this 5% proximal endoleak you can see that the chance of having proximal endoleak increases when the neck is more severely angled, which is understandable. Of the eight proximal endoleak cases, four sealed, however it's not perfect.
We had three ruptures happen. One patient still denied of having anything done further. Heli-FX is a good device to treat this proximal endoleak as shown here. Again trying to show here is that the incidence of proximal endoleak in the yellow and red bar increase
with the severely angled neck. And also the same as the adjunct procedures needed. It will be needed higher when the angled neck is more and more angled. And I believe that less than 90-degrees seem to be reasonable to treat with endovascular treatment.
On the average follow-up up to two years, we had only two late proximal endoleaks. And both had persistent type two endoleak. And I believe that caused neck dilatation. Interesting though the device did not migrate in both cases. We fixed them with a proximal cuff extension
and a chimney procedure. One of the surprise finding was the incidence of device migration was very, very low. We had only one case of 7 mm migration of the device. As we can see here, but the aneurysm shrunk, no endoleak found.
We still follow this patient very closely. So we believe that endovascular repair can be a safe, effective, and durable option for those who are not candidate for open repair. The procedure can be straightforward with good results. But sometimes with certain kind of anatomy can be very,
very difficult in this kind of anatomy. Like this case, we have to do sandwich procedure. But after four years in this case, aneurysm shrunk, no migration, no endoleak. So, Mr. Chairman, ladies and gentlemen, we believe that for AAA patients with severely angled neck
who are not candidates for open repair, EVAR should be considered. But we need longer neck length. And we may need some adjunct procedures like cuff, parallel graft, or Heli-FX. We can have a high success rate.
And once we can put the device up there, it tends to stay. And we believe that up to 90-degrees angled neck is quite reasonable for us to treat patients with the endovascular technique. Thank you for your attention.
- 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.
- Good morning. It's a pleasure to be here today and I wanted to let you know that a lot of this work that was being done earlier were really driven by physician need. As you can see, the trial as well as the EXCEL registry is finally on the way, so it's very exciting.
I'm not going to spend a lot of time on this but everybody knows the primary predictor of EVAR failure is really short necks and angulated necks. The first generations have been pretty good but they were really not intended for this type of anatomy. We see a lot of patients with really distorted anatomy
but they still have a relatively lengthy or 10 mm neck. In fact, about 80% of the EVARs treated in the United States have at least a 10 mm proximal neck. They may not be of the highest quality but they're there. So, how could be achieve better results? Basically we need to use every millimeter
of this landing zone, so that we can use the 10 mm neck to its fullest advantage and I believe when you do that, the results are fairly comparable to doing any type of above renal repair, like a fenestrated or branch graft. The stabilization of the device
during delivery is absolutely crucial. So essentially what you want to do is have a device that is able to utilize every neck angle and every millimeter of that available neck. And we know that 80% of all the patients, do have that neck. So, the new conformable endovascular device
has been around for the last five years or so but recently went into trial in December of last year. It's very different proximally than the current EXCLUDER in that the fixation system is single and it has a series of nested stents very similar to a conformable C-TAC device.
As you can see, this allows the device to conform to the anatomy, but not only that you're able to adjust the device inside too and that's actually Frank Veith's terminology, is that you're able to adjust this so that you can inch it up and utilize the entire neck.
16 French, proximal fixation, trunk length's a little bit longer than the current EXCLUDER at 5.5 to 6.5. This allows further treatment in the future going forward if you need to do a fenestrated device or branch graft device above it.
This device was designed to conform up to 90 degree angles and it's designed to seal at 10 mm necks. And, the most important aspect of it is, you're able to reposition the device once you deploy it. The mechanism is really one of being able to angle the device with a steering system
before the deployment and also afterwards and also be able to restrain the device up and down. Another major difference is that it has a 30% restraining secondary sleeve just like a ZFEN device so you're able to move this device up and down the angulated neck
and I'll show that with a case. The clinical trial in the U.S. began in December of last year and so far, I'll show you the update but unfortunately the FDA disallows us to give you any data. I can give you some of the demographics but I'll show you
that the preliminary results look excellent. The goal is to implant 80 patients in the short arm which is complete and 110 patients in the high neck arm is partially complete at almost 30 patients. The trial update objective is as outlined, there are 48 U.S. sites
and the current study enrollment is 106 patients, the short neck arm again I said is complete. Primary safety endpoints, not unlike any other device. Primary effectiveness endpoints, again freedom from all of these aspects. The first device was in 2017,
this was a relatively straightforward patient. The device performed well, this is a six month follow-up. The device had no migration issues, confirmed beautifully. But this is not really what the device was designed for. So, I'm going to give you a case of a patient that was enrolled in the high risk arm.
This patient had an 8.5 cm aneurism, 82 degree angulation, 11 mm proximal neck, turned down for EVAR or fenestrated at two other institutions in the New York City area and basically came for a third opinion as most New Yorkers do.
The aneurism looks like this and it's kind of a very angulated proximal neck with extremely torturous iliacs. This is the case that we did. You can see the device being configured here with the steering wire and when you do this,
you can see the device being able to be easily moved proximally and distally and the next portion of the video shows that steering wire kind of implanting the device into the lesser curve. - [Moderator] The device is deconstrained right? - Yes.
You can restrain it and it's a combination of being able to restrain it and open it which allows you the flexibility and as you can see with this maneuver, the device looks like it's perfectly opposed but in fact, the posterior aspect did not oppose very well.
So, we adjusted it further by increasing the posterior coverage and this is the post-op and we got a seal. There was no ballooning. This device, the ballooning is optional. So, the results have been excellent so far
with the highly angulated neck arm and we'll only see, there's only 30 patients so far but the results have been excellent so far. - [Panel Member] Rob and for you and for also Mark who presented that last case last week. When you deploy this device
it seems that you have a stiff wire, you're almost fighting the very advantage you're proposing. Do you ever consider swapping out for a floppier wire so you can then really get the native anatomy configuration? Because now that fusion image is presumably the pre-op fusion without the stiff wire.
So, I just wondered whether there's any value to that. - That's a great question. In fact, if you look at this video again, not this one but, let me see, this one, there's no wire, that the tip of the Amplatz wire is right at the tip of the device.
So that device is almost unsupported at this level, so you're able to freely flex that device back and forth without the constraints of a stiff wire. - [Panel Member] Is that your personal style or is that something that's part of it. - It's actually a recommended
and the part of the deployment process is to bring the floppy wire. So, you can use like a Glidewire Advantage or an Amplatz Super Stiff or whatever wire you like to use but it has to have a very floppy unsupported section in the proximal segments
to be able to get this kind of maneuverability. - [Moderator] So for the panel who've used this device, with all this manipulation of the proximal neck and especially in a diseased neck, is there any evidence of embolization of thrombus into the renals or distally?
- [Panel Member] Of course there is the potential for that but we haven't seen it yet and I think that the FDA IDE Trial and the registry will address that. I think that you should be careful. If there is a lot of neural thrombus in that neck
then this manipulation could be a potential risk. Actually what you're doing is, it's not that easy to get it into position in just one angulation. Sometimes you have to angulate, push it a little bit, restrain it again and reposition it to come in the perfect position,
especially for high angulation. - Yes. There's definitely a learning curve here but the learning curve actually can be achieved with just a couple of cases to be able to see how the device behaves
in the human anatomy.
- 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 for the invitation to discuss suprarenal bare stent fixation. Here are my disclosure. Aneurismal over graft extension is a part of the natural evolution and the natural history of this degenerative disease, and it could be extended to the celiac aorta
and the common iliac, as well. Regarding the extension to the celiac aorta, we have to consider the infrarenal aorta status, when we want to correct that, and mainly the lengths in between renal artery and the bifurcation of the previously implanted graft,
but also the quality of the access route from below. Most importantly is juxtarenal status, with or without bare stent, and we have nine cases of each. The way to correct this kind of failure is the use of chimney,
when fenistrated graft are not usable. And, the secondary chimney celiac extension, we have 18 cases, when there is a long aortic segment longer than 50 mm, we use a combination of a non-bare stent cuff, associated with balloon-expandable covered parallel stents.
And, when there is a short aortic segment, less than 50 mm, or a difficult access, we use an EVAS device, associated, the same way, with balloon-expandable parallel stents. When the juxtarenal aorta is free of bare stent, it's quite easy to place a wire and stents,
and there is no major contrast in between the different components of the chimney, whatever it is, a cuff extension or the use of an EVAS. It's quite different to when there is, when we have to perform a renal stenting over a bare stent, and you can see that we have to develop tricks
to stabilize a wire into the renal stent by aortic balloon, or by a renal balloon, or renal filter, but this kind of tricks are not working very well. And, we had, in some cases, the need for using push-up procedures, which means that we are exerting forces
onto the delivery system and there's a parallel stent, and that lead to compression in between the different components of this chimney. And, in addition, when there is a bare stent previously implanted, there are forces and there is room
for gutter and that's the way to get type 1 Endoleak. And, it's more difficult when the bare stent is creating a stenosis on the ostium of the renal artery, and we had here to place a stent, a bare stent, for angioplasties and to go to a push-up procedures, before implanting the endoaortic graft
and you can see that there is a lot of contrast, onto this renal stent. When there is a bare stent, there is a slight, the operating time is longer, and one type A Endoleak
more in the bare-stent population of patient but we have one occlusion stent on the non-bare stent group. Endoleak could be treated by embolization into the gutter. But, as we want to avoid this kind of difficult procedures, we use a classification,
based on the evolution profile of the aneurysm. When the neck are safe, we use EVAS to prevent type 2 Endoleak. When the neck is cylindrical, but slightly disease, we use a bifurcated graft, with infrarenal fixation. When the neck is short or when there is no neck,
we use four fenestrated graft, or tri-chimney procedures, and when there is a celiac aneurysm, we use thoracoabdominal reconstruction, using a thoracic segment, in addition with four-fenestrated graft, or a thoracic branch device.
Then, to conclude, the bare stent doesn't prevent the evolution of the aneurysmal disease, that means that we have to reconsider the use of endoaortic graft, with bare stent suprarenal fixation, just to anticipate what could happen during the evolution and the ability to perform
a secondary device extension. And thank you for your attention.
- Thank you Dr. Beard and Dr. Dietzek. Thanks to Dr. Veith also for inviting me. I don't have any disclosures, Vascular invasion. In vascular structures in the abdomen are common with malignancies such as pancreatic cancer, renal cell,
or some sarcomas. So the vascular surgeons are invited to help the oncologic surgeons to resect these big tumors. Actually, the word oncovascular surgery has been coined by these authors as you see here.
For pancreatic cancer, the vessels that are involved as Dr. Black showed you, are the portal vein or the superior mesenteric vein. Sometimes the superior mesenteric artery is involved.
With renal cell cancer, as you can see from this little picture here, the renal vein is involved but also the tumor can ascend into the inferior vena cava and up into the heart.
Sarcoma is usually involved, the IVC and the iliacs and that is a separate discussion. So when the vascular surgeon is invited to the operating room and sees the portal vein exposed and the cancer adhering to the portal vein,
a decision has to be made whether a primary resection can be done with a primary closure versus selecting a patch or as you heard, you can do a primary anastomosis
or an interposition graft either with a vein or a prosthetic. If you are doing a vein graft, the femoral vein or the internal jugular vein, as you heard, is a preferred conduit. We try to stay away from prosthetic
especially if the bile ducts or the bowel has been violated. There are some authors that talked about using cadaveric vein but the options are not very good. The challenge with these patients
is that preoperative imaging does not predict the invasion of the vessels prior so you're invited half the time when you're not prepared to tackle these problems. It also prolongs the operation for both surgeons
and if you're harvesting vein, you're having to sew an incision. So this is a table that shows you the different types of cancer that can involve the blood vessels. The problem also with pancreatic cancer
is that despite our best efforts, survival hasn't really changed significantly. This is a paper from the group in Oregon and I highly recommend it for you if you're considering to learn a little bit about what to do intraoperatively. They had 25 patients with a good follow-up there.
They looked at all the different types of reconstructions that were offered to these patients and you can predict that if you have a big defect in the portal vein, that a patch or a vein graft is the best option to fix this.
Many times, primary closure is inadequate. I also quote this paper from Dr. Black's group who have the biggest number of pancreatic cancer resections in the world. About 3% of the cases had to have a vascular resection.
You can see here in the long-term follow-up that the rate of portal vein thrombosis is fairly low and the vessels remain patent. This is a life table that shows you with all the different kinds of repairs, primary versus vein
versus patch versus graft. As you can see from this life table that primary repair and vein grafts have the best of their ability in all circumstances. In fact, when you use a prosthetic,
that the durability of these grafts is not very good. In renal cell cancer, when the renal vein is involved, you have to resect that and sometimes you have to resect a portion
of the inferior vena cava and you have to be prepared with embolization especially if the tumor goes up into the intracardiac portion. The dissection is difficult in the retro-hepatic cava and you can see that this has been classified
by some authors here. Level IV, usually requires a cardiopulmonary bypass or a circulatory arrest as you can see from these pictures. Arterial reconstruction, you've heard about so I'm going to skip that.
Now we looked at our multidisciplinary approach in our group. We had a large number of patients that required this venous or arterial resection with satisfactory results except for pancreatic cancer patients that had a poor long-term survivability.
So to summarize, intra-abdominal malignancies with vascular invasion are encountered in with the oncologic surgeons and the vascular surgeons are typically invited to come and help. I recommend autogenous reconstruction as the best choice.
A patch with a saphenous vein is also adequate. If you have to use a vein graft, the femoral vein is our preferred approach but internal jugular vein is also a good conduit. Thanks for your attention.
- Good morning, thank you, Dr. Veith, for the invitation. My disclosures. So, renal artery anomalies, fairly rare. Renal ectopia and fusion, leading to horseshoe kidneys or pelvic kidneys, are fairly rare, in less than one percent of the population. Renal transplants, that is patients with existing
renal transplants who develop aneurysms, clearly these are patients who are 10 to 20 or more years beyond their initial transplantation, or maybe an increasing number of patients that are developing aneurysms and are treated. All of these involve a renal artery origin that is
near the aortic bifurcation or into the iliac arteries, making potential repair options limited. So this is a personal, clinical series, over an eight year span, when I was at the University of South Florida & Tampa, that's 18 patients, nine renal transplants, six congenital
pelvic kidneys, three horseshoe kidneys, with varied aorto-iliac aneurysmal pathologies, it leaves half of these patients have iliac artery pathologies on top of their aortic aneurysms, or in place of the making repair options fairly difficult. Over half of the patients had renal insufficiency
and renal protective maneuvers were used in all patients in this trial with those measures listed on the slide. All of these were elective cases, all were technically successful, with a fair amount of followup afterward. The reconstruction priorities or goals of the operation are to maintain blood flow to that atypical kidney,
except in circumstances where there were multiple renal arteries, and then a small accessory renal artery would be covered with a potential endovascular solution, and to exclude the aneurysms with adequate fixation lengths. So, in this experience, we were able, I was able to treat eight of the 18 patients with a fairly straightforward
endovascular solution, aorto-biiliac or aorto-aortic endografts. There were four patients all requiring open reconstructions without any obvious endovascular or hybrid options, but I'd like to focus on these hybrid options, several of these, an endohybrid approach using aorto-iliac
endografts, cross femoral bypass in some form of iliac embolization with an attempt to try to maintain flow to hypogastric arteries and maintain antegrade flow into that pelvic atypical renal artery, and a open hybrid approach where a renal artery can be transposed, and endografting a solution can be utilized.
The overall outcomes, fairly poor survival of these patients with a 50% survival at approximately two years, but there were no aortic related mortalities, all the renal artery reconstructions were patented last followup by Duplex or CT imaging. No aneurysms ruptures or aortic reinterventions or open
conversions were needed. So, focus specifically in a treatment algorithm, here in this complex group of patients, I think if the atypical renal artery comes off distal aorta, you have several treatment options. Most of these are going to be open, but if it is a small
accessory with multiple renal arteries, such as in certain cases of horseshoe kidneys, you may be able to get away with an endovascular approach with coverage of those small accessory arteries, an open hybrid approach which we utilized in a single case in the series with open transposition through a limited
incision from the distal aorta down to the distal iliac, and then actually a fenestrated endovascular repair of his complex aneurysm. Finally, an open approach, where direct aorto-ilio-femoral reconstruction with a bypass and reimplantation of that renal artery was done,
but in the patients with atypical renals off the iliac segment, I think you utilizing these endohybrid options can come up with some creative solutions, and utilize, if there is some common iliac occlusive disease or aneurysmal disease, you can maintain antegrade flow into these renal arteries from the pelvis
and utilize cross femoral bypass and contralateral occlusions. So, good options with AUIs, with an endohybrid approach in these difficult patients. Thank you.
- The title is Why Open Surgery is Still the Best Treatment for Juxta- and Pararenal AAAs in Good Risk Patients: Technical Tips. This slide demonstrates the trends of AAA repair in our university, my institution. After the introduction of EVAR in 2007 in Japan, more than half of AAA was treated with endovascular repair.
However, open repair also remains the mainstay. After the introduction of EVAR, comparing the percentage of open repair with renal artery clamping between pre and post EVAR, there was a significant increase. Recently EVAR with fenestrated graft and snorkel technique
has been performed for the treatment of JAAA in high risk patients with favorable outcome. However, open surgery is typically used as first-time treatment in low-risk patients. We demonstrated the outcome with results in Journal of Vascular Surgery in 2018.
Among 451 open surgery, 111 underwent repair of JRAA aortic aneurysms. In hospital death was less than 1%. This study suggests that open repair of juxtrarenal and pararenal aortic aneurysms can be done safely. We will show the technical tips for juxta-
and pararenal AAAs. Operative approach, manipulation of the left renal vein, method of anastomosis and method of reconstruction of the renal artery. The position of proximal clamps were decided based on the anatomy of the aneurysmal neck,
which was two approach. One was transperitoneal approach. Proximal clamp site, it's placed in inter-renal was suprarenal, which is proximal upwards. Like this 3DCT, if the orifice of the renal artery and the SMA are at the same level,
we choose supra-celiac clamping. In those cases, we user a transabdominal approach with left-sided medial visceral rotation. As you can see the descending colon and pancreas, spleen and stomach are rotated anteriorly and medially, leaving the left kidney, adrenal gland, ureter
and gonadal vein in situ. Using this approach, we can control the orifice of the celiac artery and the SMA and both renal arteries and therefore we can directly clamp all of these arteries. After exposure, the proximal anastomosis was made without PCPS.
After finishing the proximal anastomosis, the clamp was then moved down to the graft to perfuse the renal arteries. The next, manipulation of left renal vein. This is a dissection of renal vein and dissection of the branches
such as the adrenal vein or gonadal vein frees the left renal vein and makes it easier to expose the proximal aorta and to perform proximal anastomosis. The next is on the left side with the division and stump closure.
Divide the renal vein proximally to the adrenal vein and gonadal vein and they close the stump by 4-0 prolene running sutures. On the left side it's a very rare case, but sometimes re-anastomosis in the vein. We demonstrated renal artery clamping and left renal vein
division during abdominal aortic aneurysm repair. That's not in itself compromised for long time renal function. In reaction to that, we demonstrate that in publication in Journal of Vascular Surgery, the division had no significant impact
on CRD for up to two years during follow-up. Then this is initially pressed on posterior and ends on anastomosis was performed by placing a 3-0 Prolene suture in the posterior wall and continued anteriorly in a running fashion. Regarding the renal artery perfusion,
perfusion it with cold ringer solution undertaken. The bypass graft for the renal artery was anastomosed to the main body or limb of the main graft in advance, then the main body was anastomosed to the aorta. During the aorta clamping, the renal artery was perfused with chilled solution.
Finally we demonstrated the technical tips for juxta- and pararenal AAAs. Thank you for your attention.
- Thank you so much. I have no disclosures. These guidelines were published a year ago and they are open access. You can download the PDF and you can also download the app and the app was launched two months ago
and four of the ESVS guidelines are in that app. As you see, we had three American co-authors of this document, so we have very high expertise that we managed to gather.
Now the ESVS Mesenteric Guidelines have all conditions in one document because it's not always obvious if it's acute, chronic, acute-on-chron if it's arteri
if there's an underlying aneurysm or a dissection. And we thought it a benefit for the clinician to have all in one single document. It's 51 pages, 64 recommendations, more than 300 references and we use the
ESC grading system. As you will understand, it's impossible to describe this document in four minutes but I will give you some highlights regarding one of the chapters, the Acute arterial mesenteric ischaemia chapter.
We have four recommendations on how to diagnose this condition. We found that D-dimer is highly sensitive so that a normal D-dimer value excludes the condition but it's also unfortunately unspecific. There's a common misconception that lactate is
useful in this situation. Lactate becomes elevated very late when the patient is dying. It's not a good test for diagnosing acute mesenteric ischaemia earlier. And this is a strong recommendation against that.
We also ask everyone uses the CTA angiography these days and that is of course the mainstay of diagnoses as you can see on this image. Regarding treatment, we found that in patients with acute mesenteric arterial ischaemia open or endovascular revascularisation
should preferably be done before bowel surgery. This is of course an important strategic recommendation when we work together with general surgeons. We also concluded that completion imaging is important. And this is maybe one of the reasons why endovascular repair tends to do better than
open repair in these patients. There was no other better way of judging the bowel viability than clinical judgment a no-brainer is that these patients need antibiotics and it's also a strong recommendation to do second look laparotomoy.
We found that endovascular treatment is first therapy if you suspect thrombotic occlusion. They had better survival than the open repair, where as in the embolic situation, we found no difference in outcome.
So you can do both open or endo for embolus, like in this 85 year old man from Uppsala where we did a thrombus, or the embolus aspiration. Regarding follow up, we found that it was beneficial to do imaging follow-up after stenting, and also secondary prevention is important.
So in conclusion, ladies and gentlemen, the ESVS Guidelines can be downloaded freely. There are lots of recommendations regarding diagnosis, treatment, and follow-up. And they are most useful when the diagnosis is difficult and when indication for treatment is less obvious.
Please read the other chapters, too and please come to Hamburg next year for the ESVS meeting. Thank You
- Thank you 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)
- Thank you. Thank you for the opportunity to present this technique and here are the results. Residual Type B Aortic Dissection in patients previously treated by TEVAR by frozen elephant trunk. It makes a new kind of patients need appropriate treatment.
There might be contraindication to further endovascular repair and these are associate visceral arterial dissection or occlusion, collapsed true lumen if it is relative, connective disorder, young age, excessive tortuosity and multiple renal arteries.
The reverse cactus principle is to implant two additional prosthesis to a main prosthesis very proximal and it is a four branch prosthesis like a cactus reversed and the principle is CSF drainage and potential. Left thoracophreno-laparotomy
and retroperitoneal abdominal aortic approach, left artio-femoral pump, double clamp of the proximal aorta within the endograft and make the proximal anastomosis with the graft while all the rest perfuses on below. Prepare the CT, superior mesenteric
and left renal at its origin outside the aorta and the ligature and section of the celiac trunk at its origin and anastomosis with one side-branch of the graft and then do the same with the other branches progressively while all the rest of the aneurysm is perfused
from below. Open the aorta, connect the intercostals and the right renal artery and make the distal anastomosis. So this is the double clamping of the proximal aorta and you can predict the presence of the endograft and so you have a proximal stamp.
A very firm proximal stamp when you can make the proximal anastomosis and you clamp the proximal anastomosis like blocked and so you have no ischemia and neither visceral nor spinal cord ischemia. You cut the celiac.
In this case the celiac was dissected, you identify the lumen by clamping alternately from one to the other side and you see there is the true lumen so you identify the true lumen and you suture it to this then you clamp the celiac trunk.
You do the same with the mesenteric artery and with the renal artery and then you open the sac and you perfuse the intercostals with an additional pump if necessary and after you are connected you are ready to do the distal anastomosis
and this is the final results. You see that it fits very well the anatomy into intercostal you see intercostal, intercostal and here are some examples. You see how the harmonic and the intercostals, posterior.
And so the early results were only a few patients deserved this operation but technical success was obtained in all cases. Two to six additional branches for each reconstruction. No 30 day mortality, reintervention or acute renal failure.
Spinal cord ischemia was reported unfortunately in one patient and it's a long operation but the intra-operative blood loss is contained for this kind of operation and the mean ICU stay was for 4.2 day. This is the curve of creatinine
which is a really very stable and all patients recovered within the six post recovery day. At one year reintervention was null. No patients developed late-onset renal failure. All visceral branches were present. We lost two intercostals without consequences.
In conclusion, residual type A aortic dissection is a challenging disease. The reverse cactus operation is no need for rush, it fits all anatomies, fixes associated visceral arterial disease, contains blood loss, great hemodynamic and metabolic stability
and satisfactory one year results. Thank you for your attention.
- Thank you and thanks Dr. Veath and the organizing committee for allowing me to present something that I'm very passionate about. No disclosures. The Portland VA is the main tertiary care center for the Pacific Northwest and does 80% of the complex surgery for the Pacific Northwest for the veterans.
We do such things as liver transplant there, about 300 hearts a year and overall, I have 16 surgical divisions. Everyone would agree that critical incidents or never-events or sentinel events still remain a threat to patient safety and I want to share with you today the system that the VA
has in place and one that we've put in place in our own institution to really minimize avoidable disasters. In the VA system, these are the definitions of a sentinel event or a critical incident. Wrong patient, side/site, implant or surgery.
Retained item. Death in the operating room. Death by hemorrhage within 24 hours. Or an OR fire or burn. These are things we've put in place in our own institution over the last several years to avoid disasters.
One is putting in the ... Following the World Health Organization for OR checklists. We have a high-risk patient protocol now in place. We have a robust medical even reporting system and just culture in the operating room and we have key signage which I'll share with you as well.
So, with regards to a checklist, many of you have seen this already but we actually do this. We do a pre-op briefing in the operating room with the surgeon, anesthesiologist, scrub tech, and circulator before the patients brought in.
We have a time out and fire safety check before the incision is made and then we have a pre-op debriefing after the final counts are done. In regards to a high-risk patient protocol, if a patient has a great event equal to 5% mortality with a potential operation due to the morbidities
as calculated by the VASQIP or NSQIP calculator these things must be done prior to the operation. A high-risk note must be completed. There needs to be a peer to peer review of the case. There must be a palliative care consultation. There needs to be good documentation as to why
the operation's going to be done or why not and then if the surgery is going to be done, there needs to be a plan in place with the ICU and potentially two attendings to make sure the surgery gets done well. And then at any time, stakeholders can stop the line
to have further discussion to assure that this is the right decision to take this patient to the operating room if they are truly high-risk. We have a very robust medical event reporting system and just culture in our operating room and this took a lot of work to get in place
but anybody in the operating room can put in a medical event report in the intranet and then this gets followed up by coming back to myself as well as the chief nursing director and then all these are reviewed in the surgical work group for which I chair. Here's an example.
This was done in 2017. You can see at the bottom. Instrument count was not performed prior to the incision for an A-V fistula. This was not communicated to the primary circulator. Sponge needle counts were performed in the usual manner.
Dr. Blank is aware and a preventative retention x-ray was taken in the OR. This comes back to the chief nurse. She states that that nurse was re-educated and that the proper protocol was followed and then in the work group, our OR manager basically states that a new
instrument count process is put in place. So, there is a complete accountability in a full circle to the staff that are putting in these medical event reports which are not punitive in any way. You can see that after we worked hard at this, the number of medical event reports coming in really went up
and it could be something as simple as not having the suture available. A medical event report could be put in and this will always get followed up on. This is something we did two years ago. It's like on the work site, injuries in the last year
or last day, or last week but this is week since last OR incident or never event and here when I took this picture it had been eight weeks since we had an OR burn. That burn was a 3ml inadvertent burn on another part of the body from the bovie when somebody stepped
on the foot pedal by accident. Very small, but it was reported all the way to central office. Here they are pictures when they leave the OR and this is all throughout the operating room including entry into the operating room for the core.
And you can see here our five year trend, on the left is the number of operations and on the right the number of critical incidents and this year we only have had one critical incident. Last year we only had one. So, I think the things we put in place really have
made a difference. If we have one of these, there are lots of things we can do afterwards and we actually do. We have larger groups stakeholder debriefings, peer review process, root cause analysis, something new called a unit-based ethics conversation
which I'd be happy to talk about in any questions and then we have very close conversations with our network and central office when these things occur. So, lessons learned all stakeholders should participate in implementation of these changes.
Leadership needs to really lead by example. You want to lead by example, reward reporting, problem solving and emotional intelligence and really piloting allows for buy-in prior to broad implementation. Thank you.
- 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.
- [Ali] Thank you Dr. Jordan This is the results of the trial that led to the FDA approval of the Valiant Captivia Device for treatment of aortic dissection. This is a four-year update. I have no disclosures.
This is the epidemiology of aortic dissection. As you know, the outcomes of patients with acute complicated type aortic dissection leave a lot of room for improvement. With the open-repair operative mortality approaching 50-80% when there is mesenteric or renal ischemia.
The goal of TIVAR is to stabilize the aorta and promote remodeling. This includes covering the proximal entry tear. Treating or preventing rupture to expand the true lumen, caused false lumen regression and false lumen thrombosis and to alleviate distal malperfusion.
As you know, TIVAR is now considered first line therapy for patients with acute complicated type aortic dissection and this is the current European Society for Vascular Surgery guidelines. The objective of this study was to evaluate the performance of the Valiant Captivia device
for treatment of acute complicated type aortic dissection. 50 patients were enrolled at 16 US centers. This occurred between 2010 and 2012 and the patients are being followed up for five years. This the baseline demographics. As you can see, hypertension was prevalent.
Most patients were ASA Class IV or V. Vascular history and hypercholesteremia were also prevalent. The average age was 57 and 80% of the patients were male. This is the presentation symptoms. The majority of patients presented with back or chest pain
and a staggering 86% of the patients had malperfusion. 40% has visceral ischemia. 42% had renal ischemia. 40% lower extremity ischemia and 6% spinal cord ischemia. Antihypertensives were administered to 84% of the patients with ionotropic support required in 16%. This the procedural data.
There was a 100% delivery and deployment success. The proximal entry tear was covered in 100% of the subjects. And there was no misalignment noted. The over-sizing was 12 +/- 10% and the length of coverage approached 20 cm. This is the all-cause mortality.
The freedom from all-cause mortality at four years was 77%. As you can see, outside of the 30-day window there were no moralities directly attributed to aortic dissection. There was one pnuemonia on day 87
which according to the clinical adjudication committee was ruled as a dissection-related death but it wasn't a direct aortic-related death. This gives us a four-year freedom from dissection-related mortality which is 90% and for a complex group of patients
with acute complicated type aortic dissection this is remarkable. This graph also shows that there's been aortic stabilization with TIVAR and no late complications related to the aorta. There were no serious adverse events or secondary endovascular procedures in year 2, 3, or 4.
There were some procedures related to the dissection. Four patients had extension and one patient had embolic placement. And one patient had a subclavian plug. This is the aortic remodeling data. As you look at the four-year data
the maximum diameter of the false lumen decreased or remained stable in 87% of the patients. The maximum diameter of the true lumen increased in 100% of the patients. And there was partial or complete false lumen thrombosis in 96% of the patients.
In summary, there was 100% delivery and deployment success. There was aortic stabilization through the four-year period. There were no ruptures and at 4% retrograde type aortic dissection given this viable pathology. This is favorable aortic remodeling
with low need for secondary endovascular procedures. Thank you very much for your attention.
- Thank you and good afternoon, everyone. These are my disclosures. So the characteristics of an ideal DCB. It must deliver the drug to the arterial wall during inflation, must distribute evenly within intima and media in the first few days,
and the therapeutic drug levels must be maintained for at least 28 days. The biological effects must be observed by histology at 28 days in animal models, and non-target effects should be minimum. So if you look at the Drug-Coated Balloon Devices
for the periphery there are a large number, those in the red show you the ones that have FDA approval, most of them have two or three, most of them actually, 2.0 micrograms per millimeter square of paclitaxel, whereas the other two that is Impact has 2.5 and Passeo has 3.0,
and of course, thaek-thee-piants are quite different. So here's to show you the SurVeil DCB which is a Surmodics balloon, this is showing you the coating on it, as compared to DCB #1, #2 and #3 that are already available in the market, at least in the United States,
and SurVeil is undergoing clinical trials. So what does it have? It has a 0.035 over the wire PTA platform, it has 4-7 millimeters, 40-150 millimeters in length, it has proprietary PhotoLink basecoat, and it has uniform drug topcoat,
consisting of paclitaxel and proprietary excipient which is 2.0 microgram of the drug, per millimeter square load, and it's 360 degree coating coverage, as you can see quite uniform coating, which makes it quite different from the others.
If you look at the Efficient Drug Delivery, you can look at tissue concentration, if you look at the Surmodics SurVeil, you can see that it has higher drug concentration up to 28 days, as compared to the bench DCB #2 which is 3.5 micrograms per millimeter squared.
So despite loading less drug, it has more drug in tissues. So what about the uniformity in distribution of the drug? The biological effects, these are the approved DCB, you can see that as focal effect the green showing the proteoglycan. If you look at the SurVeil DCB,
you can see that it has much more circumferential, and this is the plain old balloon. Not only that, but if you look at the biological markers of the drug effect, this is Surmodics, Benchmark DCB, which is 3.5 microgram,
I want you to note that if you look at the medial proteoglycan again, I showed you earlier here you can see it's much more so as compared to high loaded drug that is DCB which has 3.5. If you look at medial smooth muscle cell loss, much greater, that is in depth, as well as
in circumference, and if you look at endothelial loss, greater medial in Intimal Fibrin is greater and medial in intimal inflammations slightly greater. Therefore, is likely to have long-term effects. Now, looking at visible differences in the coating integrity, that is
it is submerge and deploy testing, you can see here in the Benchmark DCB #1, DCB #3 and SurVeil. You can look at this particulate material very easily, as compared to when you look at the SurVeil, we just don't see any particulates.
So visible difference in particulates released upon inflation. So we also did tracking and deployed particulate matter, that is simulated device use, prepare the balloon, track through the guide catheter in an anatomical model, inflate at 14 atm,
dwell time for 30 seconds, deflate, withdraw the balloon from the model and flush the model to recover the particulates, and the measurements are particulate count, drug retained in the balloon, and drug recovered from the mock vessel.
This is just to show you what you see as a particulate, you can see this is Surmodics, this is Benchmark #2, this is DCB #1, you can see the differences, I don't have to tell you, you can see the differences. This is 1 millimeter in size, some particles being close to 1 millimeter,
and greater, as you can see on the benchmark, as compared to what we see in the Surmodics. So if you look at the downstream effects in Glutius Maximum, Gastrocnemius, you can see that in SurVeil, you can see in Surmodics we see much less concentration of the drug
as compared to what we see in the DCB #2 which is 3.5 micrograms, and if you look at the coronary bands, minimal amount of paclitaxel seen in the concentrations. So in conclusion, currently available DCBs have downstream emboli in preclinical models that I showed you,
SurVeil DCB with advanced coating technology and a lower drug dose is able to achieve effective drug transfer into the arterial wall more circumferential, while minimizing downstream embolic effects in preclinical models. So thank you so much.
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