- 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.
- Yeah, I am not Mehdi Shishehbor. If you are here to listen to him talk, I'm sorry to disappoint you. He's stuck in Cleveland in the weather. So this is my disclosure. There are several companies, but it's uncompensated consulting.
So, when you look at all the guidelines that are out there, most of the guidelines do recommend ankle brachial index as the central point in terms of management of critical limb ischemia patients, this is the ACC/AHA guidelines from 2016. And the same thing PARC,
Peripheral Academic Research Consortium also talks about using ankle brachial indices in the management of critical limb ischemias. So Mehdi gives this example of a 82 yr old patient of his who came in with a Charcot joint and mid-foot ulceration. The ABI was in the .56 range,
so he takes her to the cath lab and finds SFA disease, PT is occluded. He gets the inflow improved, the anterior tibial also looks better, and the ankle brachial indices are now normalized to 1.12, and even the metatarsal and the digit PPGs are improved.
So he tells the patient to go home and rest, and the wound care is instituted. And the mid-foot ulceration heals, but when the patient comes back there is a heel ulceration, because the patient has been asked to take it easy, and with the non-vascular position,
which is above the level of the heart, or at the level of the heart rather than being down. Now she has sort of a pressure and ischemic ulceration on the heel, despite normal ABIs. So Mehdi goes in and do retro grade pedal axis and gets into the origin, revascularizes the arch,
and gets the PT opened up, and the DP opened up, and has a good arch, complete arch now, as you can see good result, and with good wound healing at 16 weeks it shows improvement and 21 weeks much more better looking, almost healed ulceration with some callous over that.
So the point of this is the clinical examination of the patient and continued follow up closely is very important and not just depend on ABIs. To further this thought, Mehdi looked at the Cleveland Clinic Data and 29% of patients with critical limb ischemia were noted to have, in fact,
ABIs that were almost normal. And then, the IN.PACT DEEP data, which you look at about 350 patients, all CLI patients, they looked at the hemodynamic parameters to diagnose critical limb ischemia. This was one of the trials that sort of lead to
removing ankle brachial index requirement in the critical limb ischemia below knee trials, as well. What they showed is, even though all these patients have critical limb ischemia, upwards of 28% actually had normal ABI and several had ABI greater than 1.4 And remember, all these are critical limb ischemia patients.
So probably ABI's not a good measure to assess critical limb ischemia. Similarly, the Michigan group, the Blue Cross Blue Shield group looked at 4,391 patients with CLI, and only 60% actually had mild to moderate disease,
and 14 had severe disease, and when you look at the number of patients that had normal ABIs, that was a quarter of them. So a quarter of CLI patients have normal ABIs. The other disturbing fact is that, when you look at noncompressible ABIs,
majority, up to 80% of these patients could potentially, especially the posterior tibial artery, could be upwards of 80% occlusion. So basically, if you get noncompressible vessels you could be looking at having a potential occlusion of the below knee vessel.
So in summary, about 30% of patients with CLI will have normal ABIs, or noncompressible ABIs. If they have noncompressible ABIs, upwards of 80% will have potential occlusion of severe stenosis. So at this time, in the absence of better profusion, tissue profusion imaging,
angiogram is probably the best way to assess. We need to consider TBI, pulse volume recordings, in the patients with Rutherford five and six. Thank you.
- 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.
- I'd like to thank Dr. Veith and the committee for the privilege of presenting this. I have no disclosures. Vascular problems and the type of injuries could be varied. We all need to have an awareness of acute and chronic injuries,
whether they're traumatic, resulting with compression, occlusion, tumoral and malformation results, or vasospastic. I'd like to present a thoracoscopic manipulation of fractured ribs to prevent descending aortic injury
in a patient with chest trauma. You know, we don't think about this but they can have acute or delayed onset of symptoms and the patient can change and suddenly deteriorate with position changes or with mechanical ventilation,
and this is a rather interesting paper. Here you can see the posterior rib fracture sitting directly adjacent to the aorta like a knife. You can imagine the catastrophic consequences if that wasn't recognized and treated appropriately.
We heard this morning in the venous session that the veins change positions based on the arteries. Well, we need to remember that the arteries and the whole vascular bundle changes position based on the spine
and the bony pieces around them. This is especially too when you're dealing with scoliosis and scoliotic operations and the body positioning whether it's supine or prone the degree of hypo or hyperkyphosis
and the vertebral angles and the methods of instrumentation all need to be considered and remembered as the aorta will migrate based on the body habits of the patient. Screws can cause all kinds of trouble.
Screws are considered risky if they're within one to three millimeters of the aorta or adjacent tissues, and if you just do a random review up to 15% of screws that are placed fall into this category.
Vertebral loops and tortuosity is either a congenital or acquired anomaly and the V2 segment of the vertebral is particularly at risk, most commonly in women in their fifth and sixth decades,
and here you can see instrumentation of the upper cervical spine, anterior corpectomy and the posterior exposures are all associated with a significant and lethal, at times, vertebral artery injuries.
Left subclavian artery injury from excessively long thoracic pedicle screws placed for proximal thoracic scoliosis have been reported. Clavicular osteosynthesis with high neurovascular injury especially when the plunge depth isn't kept in mind
in the medial clavicle have been reported and an awareness and an ability to anticipate injury by looking at the safe zone and finding this on the femur
with your preoperative imaging is a way to help prevent those kinds of problems. Injuries can be from stretch or retraction. Leave it to the French. There's a paper from 2011 that describes midline anterior approach
from the right side to the lumbar spine, interbody fusion and total disc replacement as safer. The cava is more resistant to injury than the left iliac vein and there's less erectile dysfunction reported. We had a patient present recently
with the blue bumps across her abdomen many years after hip complicated course. She'd had what was thought to be an infected hip that was replaced, worsening lower extremity edema, asymmetry of her femoral vein on duplex
and her heterogeneous mask that you can see here on imaging. The iliac veins were occluded and compressed and you could see in the bottom right the varicosities that she was concerned about. Another case is a 71-year-old male who had a post-thrombotic syndrome.
It was worsened after his left hip replacement and his wife said he's just not been the same since. Initially imaging suggests that this was a mass and a tumor. He underwent biopsy
and it showed ghost cells. Here you can see the venogram where we tried to recanalize this and we were unsuccessful because this was actually a combination of bone cement and inflammatory reaction.
Second patient in this category, bless you, is a 67-year-old female who had left leg swelling again after a total hip replacement 20 plus years ago. No DVTs but here you can see the cement compressing the iliac vein.
She had about a 40% patency when you put her through positioning and elected not to have anything done with that. Here you could see on MR how truly compressed this is. IVA suggested it was a little less tight than that.
So a vascular injury occurs across all surgical specialties. All procedures carry risk of bleeding and inadvertent damage to vessels. The mechanisms include tearing, stretching, fracture of calcific plaques,
direct penetration and thermal injury. The types of injuries you hear are most common after hip injuries, they need to be recognized in the acute phase as looking for signs of bleeding or ischemia. Arterial lesions are commonly prone then.
Bone cement can cause thermal injury, erosion, compression and post-implant syndrome. So again, no surgery is immune. You need to be aware and especially when you look at patients in the delayed time period
to consider something called particle disease. This has actually been described in the orthopedic literature starting in the 70s and it's a complex interaction of inflammatory pathways directed at microparticles that come about
through prosthetic wear. So not only acute injury but acute and chronic symptoms. Thank you for the privilege of the floor.
- Thank you very much. I take over the presentation from Thomas Larzon, we, and different other people have the same approach to a ruptured triple A, trying to extend the advantages we have seen now, of an EVAR procedure in patients with inadequate anatomy, and to extend the limitation,
to patients with the less favorable anatomy. So, the concept of a ruptured EVAR has been already proven, with good research of three years, and I will build up, Thomas built up this presentation, on our so common experience that we published for fourteen years experience of two university centers,
performing EVAR on 100% of ruptured abdominal aortic aneurysms, over a 32 months period. So what we can see, is on the right side, this was the period where a part of the patient was treated by EVAR,
and the one that had not favorable anatomy were opened. On the left side, there is EVAR only, this a period 2009 to 11, you can see the effect of this change, is the operative cohort mortality moved from 26 to 24%, and total cohort mortality,
including to exclude the patient that are on feet, reduced from 33 to 27%. What changed also, is the protocol for anesthesia, so from a few patients that were treated under local anesthesia, actually, there are very few patients treated
just with general anesthesia primarily. What changed is the rejection rate, decreased from 10% to 4%, the age of the population treated increased, the part of women treated increased by 10%, and the amount of patients that are instable,
and treated, increased too. So, how to extend the limitation, the one is by using parallel grafts, or on table physician modified, extend graft to achieve what Benjamin does in his practice, a good seal proximal,
this is a three parallel graft, that worked very well. The other option, is to use Onyx for the distal landing zone, this is a technique that Thomas does use more liberally than we,
but is a good solution for patients where an IBD, for example, would not be possible, it doesn't require any special catheter, there is no contraindications due to tortuosity, and sealing is immediately obtained. Here, an example,
the aortoiliac, the main trunk, has been deployed here, then a (mumbles), the iliac extension is parked, can be deployed later, and as a Buddy catheter,
you can take a Bernstein catheter, you just position it in the origin of the hypogastric, or in the common iliac artery. Then, you deploy the distal extension, there is no more flow, slowly you'll stepwise,
5-10cc of Onyx can be applied, this allows to preserve the distal perfusion of the hypogastric, and to seal it. Sealing can also, with Onyx, can also be used in the proximal landing zone, there are two options,
here, the option with an instable patient that gets two parallel graphs with the remaining type 1 endoleak, you introduce your catheter through the leak, or the catheter inside the sack that is perfused, step wise, you will apply your Onyx.
Here, in another patient, of our experience, this is a suprarenal arteries after a triple A repair with EVAR that comes with the rupture, we combined here a chimney for the SMA, with a double brach device from Biotech,
deploy this, and you can see here there will be some leak. So, three days later, because the leak didn't have to do coagulation correct, once correct it didn't seal, we just very selectively, improvised with Onyx, the gap,
this is a three months outcome. Then, here a case of some Post EVAR with a type 1A endoleak, to extend this on the visceral aorta would have been very complex, this is why doctor Larson decided here just
to fill the whole sac with 60cc of Onyx, which worked very well. So, in Orebro, you can see that the 30-day mortality is 27%, the 90-day mortality is 30%, then the whole cohort,
including the 10% that have been excluded, has a mortality of 37 and 34%. From the different factor that was significant, you can see that local anesthesia works good, Aortic Balloon Occlusion works good, mortality in patients
with abdominal compartment syndrome is increased, mortality of patients in shock is increased, and finally, the mortality of patients having this adjunct procedure is not significantly increased, this holds true for the long-term outcomes.
So, we can see that by using adjuncts, every patient with a ruptured triple A can be offered an EVAR, eventually as a bridging procedure, chimney grafts can extend landing zones, Onyx can offer additional sealing options,
and valid long-term results for adjuncts has been proven. Thank you very much for your attention.
- So, this is a prerecorded case. This is my disclosures. Well, we've all seen the concept of Percutaneous Venous Arterialization and this was discussed several sessions ago in the main hall of going crossing from an artery into vein and having multiple stent step would re-line the
venous wall and take away the valves and to bring blood to the capillary bit. Quickly, this is the animation of what goes on. An antegrade seven french sheath, a retrograde five french sheath. An ultrasonic system with alignment between the
artery and the vein and then a needle is driven, wired, pre-dilatation. The use of a 4 french valvulotome to cut the valves in the foot, to de-valvulotomize the valves and then after that, align the whole vein with a covered stent
to do an endovenous bypass. So, this is a prerecorded case courtesy of Dr. Daniel van Den Heuvel, an Interventional Radiologist out of Netherlands. So, this is a 70 year old lady with ulcer in the first and the fifth toe, Rutherford five.
Diabetic, hypertensive and failed conventional intervention. So, I'll start the video right now. Could we have volume please? Yeah, thank you. - Okay. (beeping) - Feel free to ask any questions.
I can pause the video. - [Doctor] So, we see proximal occlusions of the tibial vessels, and all collaterals going down to the foot. So, no direct target vessel for revascularization. So we apply the tourniquet with an Esmarch.
- So now, he's actually getting venous access at the-- - (mumbles) in the vessel. - Retro (mumbles) area. - Gently past the probe. Okay, so now the-- - I'll just pause over here. This is the device with the retrograde five french sheath
and the five french catheter, and the antegrade device that allows you to cross over an artery to the vein, and this is properly aligned in this case. - [Doctor] Marker of the arterial probe is at the same level as the venous probe. Let's fix it with a wet gauze, please.
And then, let's fix it and connect the arterial probe. So, I think this is the maximal-- - So, the ultrasound system allows a predictable crossing between an artery and the vein. - [Doctor] Feed and retract the venous probe. So, leave the sheath in while they are about
to retract the venous probe. Maybe, yeah. Also, pull down the sheath a little bit. - After alignment, the one probe is removed to give space for the crossing. - [Doctor] Yup, okay.
To puncture with a needle, you need to turn the device to unlock it and then advance it. Yeah. So, I unlock it. Okay. Yeah, this, see some contrast.
So, at the same time, we'll do the puncture with the needle. - That was quite subtle. You could see the needle push against the vein wall and it went right through the vein wall. - [Doctor] And then see what happens. - And, now, with an over the wire system,
you're able to introduce a wire. - [Doctor] It's in right away. - You know you're in the vein because of the appearance of the wire abutting a valve. - [Doctor] We can try to correct for that in the later stage.
- So, now, with a support of a CXI catheter, he's trying to catheterize the appropriate vein. - This is probably the right (mumbles) so. Okay, so this is the right one, so we crossed in the middle.
So, now, again, we go distal and lead gently. Try to, aha! Now, we're in the sheath. Okay, false.
Try for several times. If not, then-- So, okay, so probably now, already past the puncture point. Be gentle, just wait for the valve to open and not to push too much.
- So, the next step is to cross the valves and this maneuver is usually done with a variety of wires and the main thing that you need is actually patience. - Don't go too far (mumbles)-- - So, this could be supported with a balloon or a CXI catheter or any other catheter. - Yeah, okay.
Okay, and the wire is better. But, is it the right one? Yeah, okay. - The tourniquet is still on that you have gauzes or is it-- - Usually, at this point, after the crossing, you can actually take the tourniquet off, so--
- [Professor] The contrast is staying here in the-- - Yes, I think he probably injected some contrast through a superficial vein to maybe give a better visualization of the anatomy. So, I think, in this case, probably there was some either the tonic,
it wasn't off, or he injected some contrast. It can be useful. You know, it's not harmful to the patient. - [Doctor] Vein we're targeting, so. Now, we should be able to cross the-- - So, there are plenty of valves
in the foot. - The feet arch. - There's usually one in the mid area here. So, he was able to cross this. And then, after that, you're able to cross the venous arch with no problems because it's not diseased as like the arterial arch.
So, fairly predictable pattern of, very much similar the arterial system is in this case. - [Doctor] So, now, you open up the valvulotome. Close the two E again. Now, you can do like forward cutting with the valvulotome
It has, you see, and we know where there are valves here. You see the tapering of the valvulotome and now it's open. - So, when the valvulotome engages a valve, maybe I can double back a little bit. - [Doctor] Now it's open.
- A little bit more. - [Doctor] Forward cutting with the valvulotome. - So, when the valvulotome engages the valve, you can see a nearing of the valvulotome and then suddenly there's a jump and then the valve, the valvulotome opens up again.
- [Doctor] The valvulotome and now its open. - That's it. So, that's the typical appearance of how a valvulotome would cut the valve and we would rotate the valvulotome and cut it in multiple locations.
And then, the, this is implantation with a stent and we would generally avoid the bifurcation of the medial lateral plantar vein. So, this stent is a 5.5 millimeters at the bottom end. And, a tapered stent on the top. Maybe I'll just quickly--
- [Doctor] No more space, so I will just-- Dip finish. - Move up, so as he's continuing to stack up the stents-- - [Doctor] Preparing some, yeah. - And then, do an angiogram. You can see the area that you want to cross.
- [Doctor] So, now we can clearly see the ostium of the posterior tip. So, I want to stay distal of that. - So, this is done from a 3.5 to a 5.5 stent to make sure that we don't cover the origin of the perioral artery to prevent ex--
Occlusion of the collateral. - [Doctor] Do a longer inflation, so we have to five balloon again. - And post dilatation is done and-- - Okay. - In this case. - [Doctor] Yeah.
Four millimeter or a five. - This is done with a five. This looks like a five millimeter. Basically, to essentially rupture the vein, the vein is only serving as a conduit and after that, the stent is able to expand. So, this is a very nice picture
of good flow-- - It's nice. - No residual stenosis and good flow up the arch as well. And then, at the proximal end, I believe, he probably did some post dilatation as well. - [Doctor] Okay, here. - And sometimes, we do add on a (mumbles)
stent if the vessel is diseased on top, you know, but I think not in this case. In the proximal end, very good flow. Over here, the origin and-- So, this patient, pre-procedure, had gangrene over the tip of the toe and after that,
the gangrene had healed and on this site, not sure if this is gangrene or just a nail infection, but we know it got better and you can see that the foot is visibly different between before and after the procedure. It always look a little bit swollen,
but swelling has never become a major issue on a chronic phase. We haven't had patients come back with venous ulceration or anything along those lines. So, with that, I'd like to thank you. And this is a 3-D rotational angiogram
of, not a CT scan, rotation angiogram of what it looks like after the procedure. Thanks. - [Man] Fine. (applauding) - [Professor] Thank you, Steven,
for this great presentation, a really fascinating technology. I have a small question over-- - Yes, Professor. - What about digital arteries? Because in your picture, I never saw the digital arteries
after the bypass. - Yeah, Professor, that's a very good question and this is a problem that we continue to grapple with and we find it's seems to be unable to be solved because there are valves at the metatarsal and digital veins that go into the, to the toe.
And, one of the shortcomings of this procedure, it seems that we are unable to push the blood as distal as we want to push like a conventional angioplasty. So, I'm not sure if we're able to circumvent this for the future because, as you know,
the veins in the foot and the toes are really really very small and prone to spasm and very high restenosis. So, in the future, if we're able to bring the blood forward instead of a fly by across the foot, you know, like a conventional angiogram,
this may hold a future for what we're doing. But, until now, we don't really have something like that. What we can do and what Roberto has done is to focalize and to selectively pressurize the flow forward with a selective embolization of large collaterals like the great saphenous vein
or even surgical ligation. But, this is, you have to do it very gently 'cause if you, if you take away these outflows, then there's a risk of thrombosis, but if you have too many outflows, then the blood does not reach the foot in front,
you know, so this could be a potential for studies in future. Maybe pressure monitoring or something along that line. Yeah. - And what about the patency? - The patency?
Well, the patency is not very good in this procedure, as I must confess, you know. We do have re-intervention for this procedures, but a re-intervention is actually quite simple if you are able to survey it, mostly like a bypasses in the distal end.
So, one wire, one drug coated balloon would usually solve the problem if you detect it before thrombosis. If you do have thrombosis, then it's going to be a problem because it's like a bypass. You have to use a Rotarex disc, that's been my experience,
to clean up the whole graph. Quite quick and then do a bit of thrombolysis to clear the clot that's in the veins and certainly the secondary patency is not so good if the, if the veins all thrombose because with thrombosis,
the veins have a intense scarring and inflammatory process, so I find that the benefit of re-intervention early is much better in terms of the clinical as well as the angiographic outcome and the perfusion as well.
So, surveillance like how you would survey for a distal bypass and treat the stenosis early. - It's Lisa. (mumbles) - Okay, thank you very much for this very nice presentation.
- Thank you very much. After these beautiful two presentations a 4D ultrasound, it might look very old-fashioned to you. These are my disclosures. Last year, I presented on 4D ultrasound and the way how it can assess wall stress. Now, we know that from a biomechanical point,
it's clear that an aneurysm will rupture when the mechanical stress exceeds the local strength. So, it's important to know something about the state of the aortic wall, the mechanical properties and the stress that's all combined in the wall.
And that could be a better predictor for growth and potential rupture of the aneurysm. It has been performed peak wall stress analysis, using finite element analysis based on CT scan. Now, there has been a test looking at CT scans with and without rupture and given indication
what wall stress could predict in growth and rupture. Unfortunately, there has been no longitudinal studies to validate this system because of the limitations in radiation and nephrotoxic contrast. So, we thought that we could overcome these problems and building the possibilities for longitudinal studies
to do this similar assessment using ultrasound. As you can see here in this diagram in CT scan, mechanical properties and the wall thickness is fixed data based on the literature. Whereas with 3D ultrasound, you can get these mechanical properties from patient-specific imaging
that could give a more patient-specific mechanical AA model. We're still performing a longitudinal study. We started almost four years ago. We're following 320 patients, and every time when they come in surveillance, we perform a 3D ultrasound. I presented last year that we are able to,
with 3D ultrasound, we get adequate anatomy and the geometry is comparable to CT scan, and we get adequate wall stressors and mechanical parameters if we compare it with CT scan. Now, there are still some limitations in 3D ultrasound and that's the limited field of view and the cumbersome procedure and time-consuming procedures
to perform all the segmentation. So last year, we worked on increased field of view and automatic segmentation. As you can see, this is a single image where the aneurysm fits perfectly well in the field of view. But, when the aneurysm is larger, it will not fit
in a single view and you need multi-perspective imaging with multiple images that should be fused and so create one image in all. First, we perform the segmentation of the proximal and distal segment, and that's a segmentation algorithm that is
based on a well-established active deformable contour that was published in 1988 by Kass. Now, this is actually what we're doing. We're taking the proximal segment of the aneurysm. We're taking the distal segment. We perform the segmentation based on the algorithms,
and when we have the two images, we do a registration, sort of a merging of these imaging, first based on the central line. And then afterwards, there is an optimalisation of these images so that they finally perfectly fit on each other.
Once we've done that, we merge these data and we get the merged ultrasound data of a much larger field of view. And after that, we perform the final segmentation, as you can see here. By doing that, we have an increased field of view and we have an automatic segmentation system
that makes the procedure's analysis much and much less time-consuming. We validate it with CT scan and you can see that on the geometry, we have on the single assessment and the multi assessments, we have good similarity images. We also performed a verification on wall stress
and you can see that with these merged images, compared to CT scan, we get very good wall stress assessment compared to CT scan. Now, this is our view to the future. We believe that in a couple of years, we have all the algorithms aligned so that we can perform
a 3D ultrasound of the aorta, and we can see that based on the mechanical parameters that aneurysm is safe, or is maybe at risk, or as you see, when it's red, there is indication for surgery. This is where we want to go.
I give you a short sneak preview that we performed. We started the analysis of a longitudinal study and we're looking at if we could predict growth and rupture. As you can see on the left side, you see that we're looking at the wall stresses. There is no increase in wall stress in the patient
before the aneurysm ruptures. On the other side, there is a clear change in the stiffness of the aneurysm before it ruptures. So, it might be that wall stress is not a predictor for growth and rupture, but that mechanical parameters, like aneurysm stiffness, is a much better predictor.
But we hope to present on that more solid data next year. Thank you very much.
- Thank you to the moderators, thank you to Dr. Veith for having me. Let's go! So my topic is to kind of introduce the ATTRACT trial, and to talk a little bit about how it affected, at least my practice, when it comes to patients with acute DVT.
I'm on the scientific advisory board for a company that makes IVC filters, and I also advise to BTG, so you guys can ask me about it later if you want. So let's talk about a case. A 50-year-old man presents
from an outside hospital to our center with left lower extremity swelling. And this is what somebody looks like upon presentation. And pulses, motor function, and sensation are actually normal at this point.
And he says to us, "Well, symptoms started "three days ago. "They're about the same since they started," despite being on anticoagulation. And he said, "Listen guys, in the other hospital, "they wouldn't do anything.
"And I want a procedure because I want the clot "out of me." so he's found to have this common femoral vein DVT. And the question is should endovascular clot removal be performed for this patient?
Well the ATTRACT trial set off to try and prevent a complication you obviously all know about, called the post-thrombotic syndrome, which is a spectrum from sort of mild discomfort and a little bit of dyspigmentation and up
to venous ulcerations and quite a lot of morbidity. And in ATTRACT, patients with proximal DVT were randomized to anticoagulation alone or in combination with pharma mechanical catheter-directed thrombolysis.
And the reason I put proximal in quotes is because it wasn't only common sort of femoral vein clots, but also femoral vein clots including the distal femoral vein were included eventually. And so patients with clots were recruited,
and as I said, they were randomized to those two treatments. And what this here shows you is the division into the two groups. Now I know this is a little small, but I'll try and kind of highlight a few things
that are relevant to this talk. So if you just read the abstract of the ATTRACT trial published last year in the New England Journal of Medicine, it'll seem to you that the study was a negative study.
The conclusion and the abstract is basically that post-thrombotic syndrome was not prevented by performing these procedures. Definitely post-thrombotic syndrome is still frequent despite treatment. But there was a signal for less severe
post-thrombotic syndrome and for more bleeding. And I was hoping to bring you all, there's an upcoming publication in circulation, hopefully it'll be online, I guess, over the weekend or early next week, talking specifically about patients
with proximal DVT. But you know, I'm speaking now without those slides. So what I can basically show you here, that at 24 months, unfortunately, there was no, well not unfortunately,
but the fact is, it did cross the significance and it was not significant from that standpoint. And what you can see here, is sort of a continuous metric of post-thrombotic syndrome. And here there was a little bit of an advantage
towards reduction of severe post-thrombotic syndrome with the procedure. What it also shows you here in this rectangle, is that were more bleeds, obviously, in the patients who received the more aggressive therapy.
One thing that people don't always talk about is that we treat our patients for two reasons, right? We want to prevent post-thrombotic syndrome but obviously, we want to help them acutely. And so what the study also showed,
was that acute symptoms resolved more quickly in patients who received the more aggressive therapy as opposed to those who did not. Again, at the price of more bleeding. So what happened to this patient? Well you know,
he presented on a Friday, obviously. So we kind of said, "Yeah, we probably are able "to try and do something for you, "but let's wait until Monday." And by Monday, his leg looked like this, with sort of a little bit of bedrest
and continued anticoagulation. So at the end of the day, no procedure was done for this particular patient. What are my take home messages, for whatever that's worth? Well I think intervention for DVT
has several acute indications. Restore arterial flow when phlegmasia is the problem, and reduce acute symptoms. I think intervention for common femoral and more proximal DVT likely does have long-term benefit, and again, just be
on the lookout for that circ paper that's coming out. Intervention for femoral DVT, so more distal DVT, in my opinion, is rarely indicated. And in the absence of phlegmasia, for me, thigh swelling is a good marker for a need
for a procedure, and I owe Dr. Bob Schainfeld that little tidbit. So thank you very much for listening.
- Thank you Mr. Chairman, thank you Dr. Veith for the kind invitation. I have no disclosures relevant to this particular lecture. But I think we ought to talk about what critical limb ischemia is. Obviously it's what we call Rutherford four through six. It's most commonly associated with multi-level disease.
About 1/3 or so of the cases are infrapopliteal only, mostly in diabetic patients. There's very poor overall life expectancies. We look at this group of patients in multiple studies, it ranges somewhere between three and four years of average life expectancy,
and there are substantial differences in outcomes within critical limb ischemia, with far worse outcomes in those with poor overall health, advanced stage presentation, or poor runoff at the level of the foot. Now, what is the rationale for endovascular therapy
in critical limb ischemia? Well first, patients are often old and infirmed, and many aren't really considered candidates for open surgery because of poor overall health. Surgery requires inflow, usually attainable. Outflow, not always so easy.
A conduit, which typically should be vein, if we want durable results, and an incision. Active infection is problematic, as there may be graft infection or sepsis. Extensive surgical scarring may compromise future rescue intervention,
and this is a progressive disease, that often requires additional treatment. Now, there have been multiple publications, and this is just a recent one, which came out in the Journal of the American Heart Association. It's a multidisciplinary,
retrospective analysis of Medicare data in people who had presented with critical limb ischemia. This is not perspective, it's not sited in many areas, but I ask you to look at this conclusion. It was there was lower major amputation rates following endovascular therapy.
Both surgery and endovascular did better than primary amputation, in terms of outcomes. But again, this is not a perfect study. Now, we have many publications which have shown very good limb salvage rates in patients using interventions.
Here we see this from Faglia, again showing very low major amputation rates. This from Sam Ahn, once again, very good limb salvage rates. But in truth, we have only one randomized, control trial, level one data, comparing intervention with surgery. And that was the BASIL Trial.
The BASIL Trial is an old trial, it's criticized, appropriately, because the only treatment used was sub-intimal angioplasty. And with sub-intimal angioplasty, often, the sub-intimal tract in crossing is far greater than the area of total occlusion,
resulting in much longer treatment zones. In addition, this trial did not allow some of the new and better treatments that are now available for having better patency to be performed. Nonetheless, in the BASIL Trial, despite very primitive treatment,
that being only sub-intimal angioplasty, we can see that one year out, and in fact out to two years, angioplasty and surgery were relatively equal in terms of limb salvage. At five years, there seemed to be a major advantage to surgery,
in terms of both quality of life, and in terms of less need for reintervention. So then we have to ask, what has changed since BASIL? Well now we have far better crossing. We have re-entry tools that stop us from having to go 10 centimeters
beyond the area of occlusion to get back in. Dedicated crossing tools, better wires, retrograde access, this is important, we have markedly improved patency, with drug coated balloons, drug-eluting stents, wire interwoven nitinol stents, and stent grafts, which have shown in the SFA all of these things,
better SFA patency, and if indeed, we can maintain SFA patency in multi-level disease, often, if there's recurrence, the patients do well. We also have improved Tibial patency in the proximal tibial vessels. However, we do not yet have a great endovascular solution
for long distal tibial vessel occlusions, and that's just the truth. I have to go back here, one, but we have better medical therapy too. As we look at PCSK9 inhibitors, in the GLAGOV Trial, we see in other parts of the body,
a 30% reduction in atherosclerotic volume out at 70 weeks, indeed will this change what we're doing. This has launched this decade of endovascular interventions. So what about this taking away surgical options? BASIL, I think, doesn't apply because the sections went far beyond where they should.
That's bad technique. Stenting across the common femoral or patent popliteal, in my opinion, bad technique. Distal embolization, we've not done enough preparation. I will also caution that sometimes, surgery has bad outcomes as well.
So, the rationale is we really don't want to perform anything that hurts a patient. Entire procedures performed via a sheath, remote from the site, there's less pain, shorter recovery, no extensive scar, and the argument that intervention
takes away surgical options, I think is no longer so valid. Bad intervention or bad surgery, take away options. Where is distal bypass indicated? In large non-healing ulcers in patients with good life expectancy, good quality vein, good outflow, and excellent surgical expertise.
Densely calcified long segment infrapopliteal disease, or disease from the common femoral all the way to the ankle. I think these clearly are going to do better with surgery, certainly in today's world. But even these areas may change. If more effective tools solve the patency problems,
with long segment infrapopliteal disease, and there are trials now aiming at this, such as SAVAL, DCB trials, and Lithoplasty. I thank you for your attention.
- That's a long title, thank you. We shortened the title, and just said, The Iliac Artery's Complicating Complex Juxtarenal and Thoracal Abdominal Repair. I have no disclosures. So, Iliac artery preservation is important whenever we start doing complex aortic aneurysm repair.
We don't understand completely what the incidence is with these extensive aneurysms. We know with AAAs, anywhere in the 10 to 40% have some sort of iliac artery involvement. It certainly can complicate the management as we get to these more complicated repairs.
Iliac artery preservation may be important for prevention of spinal cord ischemia, and those people in whom we can maintain both hypogastric arteries, it occurs at a less significant rate, with less severe symptoms and higher rates of recovery.
The aim of our study was to evaluate the incidence, management, and outcomes of iliac artery aneurysms associated with complex aortic aneurysms treated with fenestrated and branched endografts. Part of a PS-IDE study over a 15 year period of time,
this is dated from the Cleveland Clinic for the treatment of juxtarenal aneurysms and thoracal abdominal aortic aneurysms. For the purpose of this study, we defined an iliac artery aneurysm is 21 mm or greater as determined by diameter
by our core lab. We chose 21 mm because this was outside of the IFU for the iliac wounds that we had currently available to us at that time. We did multivariable analysis on the number of different outcomes. And we looked at the incidence
of iliac artery aneurysms by repair type. In all the aneurysms we treated, we see about a third of the patients had some level of iliac artery aneurysm involvement. In those patients that had less extensive thoracal abdominals, the type three
and type four abdominals, it occurred in about a third of the cases. A little bit less than the type two and the type one thoracal abdominals. We look at the demographics between those that had iliac artery aneurysm
involvement and those that did not have iliac artery involvement. It was more common in males to have iliac artery involvement than any other group. There are more females that didn't have iliac artery aneurysms. The rest
of the demographics were the same between the two groups. We look at the anatomic characteristics of the iliac artery aneurysms, about 60% of them were unilateral, about 40% of them were bilateral.
The mean iliac artery aneurysm size was 28 mm and that was the same on both sides. And we look at thought the percent that were actually very large, or considered large enough to potentially in and of themselves the repairs
greater than three centimeters. About 28% of them were greater than three centimeters on each side. If we look at our iliac artery aneurysm treatment type, this is 509 iliac artery aneurysms that
were treated out of all these patients. About 46% of them, we were able to obtain a seal distal to the iliac artery aneurysm. So it really only involved the proximal portion, the proximal half of the iliac artery.
20% of them, we placed a hypogastric branched endograft, and about 20% of them, we placed a hypogastric coverage plus embolization of that internal iliac artery. About 13% of them were left untreated at the time for a variety of different operative reasons.
Why is there a difference between the hypogastric coverage and embolization? It was availability of devices and surgeon choice at the time. At one point, we had a opportunity to be able to treat both fairly easily
on both sides and at one point we did not. Larger iliac artery aneurysms were treated with hypogastric coverage or hypogastric branched endografts, and there was a significant difference between the two. Most of the mean
size of those that were actually treated with either hypogastric branch or embolization for greater than three centimeters. If we look at peri-operative outcomes in those without iliac artery aneurysms versus those with iliac artery aneurysms.
We see that the fluoroscopy estimated blood loss is larger for those with iliac artery aneurysms, fluoroscopy time was longer and procedure duration was a bit longer as well. Obviously, a bit more complicated procedure,
more steps that's going to take a little bit longer to perform them. It did not effect the length of stay for these patients or the length of stay in the intensive care unit following the procedures. We look
at all-cause mortality at five years, no difference in whether they had an iliac artery aneurysm or not. It didn't matter whether it was unilateral or bilateral. If we look at aneurysm-related mortality, it's the same whether
they had the iliac artery aneurysm or not. Same for unilateral versus bilateral as well. Where we start to see some differences are the freedom from reintervention. This did vary between, among the three groups. In those patients without an iliac
artery aneurysm, they had the lower reintervention rate than those with the unilateral iliac artery aneurysm, and even lower rates from freedom from reintervention in those that had bilateral iliac artery aneurysms. Spinal cord ischemia, one of the
reasons we try to preserve both the hypogastric arteries. Look at our total spinal cord ischemia incidents. It didn't vary between the two groups, but if we look specifically, the type two thoracal abdominal aortic aneurysms in those patients that had bilateral
iliac arte higher rate of spinal cord ischemia compared to those that did not have any iliac artery aneurysms or those that had an internal iliac, a single iliac artery aneurysm.
So, iliac artery aneurysms affect about a third of the patients with complex aortic disease. They do not, their presence does not affect all-cause mortality or aneurysm related mortality. They are associated with a higher reintervention rate.
In extensive aneurysms, may be higher association with higher spinal cord ischemia rates. We need additional efforts are needed to improve outcomes and understanding appropriate application of different treatment options for patients with
complex aortic disease. Thank you.
- Good morning, thank you very much to Dr. Veith and Professor Veith and the organizers. So this is real holography. It's not augmented reality. It's not getting you separated from the environment that you're in. This is actually taking the 3D out of the screen
so the beating heart can be held in the palm of your hand without you having to wear any goggles or anything else and this is live imaging. It can be done intra-procedure. This is the Holoscope-i and the other one is the Holoscope-x
where in fact you can take that actually 3D hologram that you have and you can implant it in the patient and if you co-register it correctly then you can actually do the intervention in the patient
make a needle tract to the holographic needle and I'm going to limit this to just now what we're actually doing at the moment and not necessarily what the future can be. This is ultimate 3D visualization, true volumes floating in the air.
This is a CT scan. So it started working, So we get rid of the auto-segmented and you can just interact. It's floating 45 centimeters away from you and you can just hold the patient's anatomy here and you can slice into the anatomy.
This is for instance a real CT of an aorta with the aortic valve which they wanted to analyze for a core valve procedure. This is done by Phelps. If you take the information
and they've looked at the final element analysis and interaction between the stem and the tissue. So here you can make measurements in real time. So if you did the 3D rotation and geography and you had the aorta and you wanted to put in a stent graft EVAR TVAR, and you would see,
and you could put in a typical tuber that you would do, and you could see how it, and this is a dynamic hologram, so you can see how it would open up, you can mark where your fenestration's chimney is and all that type of stuff would be. And you can move it around, and you have
a complete intuitive understanding of a, can we go to the next slide please, I can't, it seems to be clicking, thank you. So how do we do all this? Well, to create a hologram, what you need to do is just conceptualize it as printing in light.
Like if you had plastic and you took the XYZ data and you just put it into a 3D printer, and it would print it for you in light, then you'd go, Okay, so I understand, if it was printed for you in plastic then you'd understand. But imagine it's printing in light.
So we have every single piece of light focused, each photon is focused so that you can see it with a naked eye, in a particular place, but the difference is that it's totally sterile, you don't have to take off your gloves, you don't have to use a mouse,
you can interact with it directly. And all the XYZ data is 100% in place, so we've just seen a beautiful demonstration of augmented reality, and in augmented reality, you have to wear something, it isolates you from the environment that you're in, and it's based on
stereoscopy, and stereoscopy is how you see 3D movies, and how you see augmented reality, is by taking two images and fusing them in one focal plane. But you can't touch that image, because if you look at me now, you can see me very well, but if you hold your finger up 45 centimeters
and you focus on your finger, I become blurred. And so, you can only focus in one plane, you can't touch that image, because that image is distant from you, and it's a fused image, so you have the focus plane and you have the convergence plane, and this is an illusion
of 3D, and it's very entertaining, and it can be very useful in medical imaging, but in intra-operative procedures it has to be 100% accurate. So you saw a very beautiful example in the previous talk of augmented reality, where you have gesturing, where you can actually gesture with the image,
you can make it bigger, you can make it smaller. But what RealView does by creating real holography, which is all the XYZ data, is having it in the palm of your hand, with having above 20 focal planes, here, very very close to your eye, and that in another way, of having all those focal planes not only actually lets you
do the procedure but prevents nausea and having a feeling of discomfort because the image is actually there as of having the illusion of the images there. So just to go back, all RealView imaging is doing, is it's not changing your 3D RA cone, BMCT, MRI,
we can do all those XYZ datas and we can use them and we can present them, all we're doing, so you use your acquisition, we're just taking that, and we're breaking open the 3D displays and seeing all that 3D data limited in the 2D screen, let's set it free and have it floating in the air.
So we have the holoscope-i for structural cardiology and electrophysiology, and obviously the holoscope-x, which makes the patient x-rayed, completely visible. So its an over the head, this is now, obviously, free-standing when somebody buys us like Phillips or Siemens, it will be integrated into your lab,
come down from the ceiling, it's an independent system, and you just have a visor that you look through, which just goes up and down whenever you want to use it. You can interact with it the same as you do with your iPhone you can visualize, you can rotate, you can mark, you can slice, you can measure, as I showed you
some examples of it, and you can do this by voice as well, you just talk to it, you say slice and you slice it with your hand, it recognizes everybody's hand, there's no delay for whatever you're imaging. So structural cardiac procedures, this is what
a mitral valve will look like, floating in the air in front of you, you can see the anterior leaflet, the posterior leaflet. And once the catheter is inside and you're guiding the catheter inside the procedure, you can turn on your doppler, you'll be able to see that the catheter
movements, so for someone doing a mitral clip, or whatever, this would be very very useful. This is an electrophysiological procedure, and you can see how the catheter moves, when the catheter will move, and obviously, as my previous speaker was saying, you are appreciating 3D in a 2D screen,
so it's very difficult to appreciate, you'll have to take my word for it. But I think you can see dynamic colography at this quality, that you can interact with, that is something that is very special, we've presented at a number of conferences,
including at Veith, and we've already done a first in man, and the most exciting thing for now, is just this week, the first machine was installed at Toronto general, at the Peter Munk Cardiac Center, and they've done their first case, and so now we are launching and clinical trials in 2018, and hopefully,
I'll have something which is more vascular relevant, at the next time, Veith 2019, thank you very much.
- Thank you. I have two talks because Dr. Gaverde, I understand, is not well, so we- - [Man] Thank you very much. - We just merged the two talks. All right, it's a little joke. For today's talk we used fusion technology
to merge two talks on fusion technology. Hopefully the rest of the talk will be a little better than that. (laughs) I think we all know from doing endovascular aortic interventions
that you can be fooled by the 2D image and here's a real life view of how that can be an issue. I don't think I need to convince anyone in this room that 3D fusion imaging is essential for complex aortic work. Studies have clearly shown it decreases radiation,
it decreases fluoro time, and decreases contrast use, and I'll just point out that these data are derived from the standard mechanical based systems. And I'll be talking about a cloud-based system that's an alternative that has some advantages. So these traditional mechanical based 3D fusion images,
as I mentioned, do have some limitations. First of all, most of them require manual registration which can be cumbersome and time consuming. Think one big issue is the hardware based tracking system that they use. So they track the table rather than the patient
and certainly, as the table moves, and you move against the table, the patient is going to move relative to the table, and those images become unreliable. And then finally, the holy grail of all 3D fusion imaging is the distortion of pre-operative anatomy
by the wires and hardware that are introduced during the course of your procedure. And one thing I'd like to discuss is the possibility that deep machine learning might lead to a solution to these issues. How does 3D fusion, image-based 3D fusion work?
Well, you start, of course with your pre-operative CT dataset and then you create digitally reconstructed radiographs, which are derived from the pre-op CTA and these are images that resemble the fluoro image. And then tracking is done based on the identification
of two or more vertebral bodies and an automated algorithm matches the most appropriate DRR to the live fluoro image. Sounds like a lot of gobbledygook but let me explain how that works. So here is the AI machine learning,
matching what it recognizes as the vertebral bodies from the pre-operative CT scan to the fluoro image. And again, you get the CT plus the fluoro and then you can see the overlay with the green. And here's another version of that or view of that.
You can see the AI machine learning, identifying the vertebral bodies and then on your right you can see the fusion image. So just, once again, the AI recognizes the bony anatomy and it's going to register the CT with the fluoro image. It tracks the patient, not the table.
And the other thing that's really important is that it recognizes the postural change that the patient undergoes between the posture during the CT scan, versus the posture on the OR table usually, or often, under general anesthesia. And here is an image of the final overlay.
And you can see the visceral and renal arteries with orange circles to identify them. You can remove those, you can remove any of those if you like. This is the workflow. First thing you do is to upload the CT scan to the cloud.
Then, when you're ready to perform the procedure, that is downloaded onto the medical grade PC that's in your OR next to your fluoro screen, and as soon as you just step on the fluoro pedal, the CYDAR overlay appears next to your, or on top of your fluoro image,
next to your regular live fluoro image. And every time you move the table, the computer learning recognizes that the images change, and in a couple of seconds, it replaces with a new overlay based on the obliquity or table position that you have. There are some additional advantages
to cloud-based technology over mechanical technology. First of all, of course, or hardware type technology. Excuse me. You can upgrade it in real time as opposed to needing intermittent hardware upgrades. Works with any fluoro equipment, including a C-arm,
so you don't have to match your 3D imaging to the brand of your fluoro imaging. And there's enhanced accuracy compared to mechanical registration systems as imaging. So what are the clinical applications that this can be utilized for?
Fluoroscopy guided endovascular procedures in the lower thorax, abdomen, and pelvis, so that includes EVAR and FEVAR, mid distal TEVAR. At present, we do need two vertebral bodies and that does limit the use in TEVAR. And then angioplasty stenting and embolization
of common iliac, proximal external and proximal internal iliac artery. Anything where you can acquire a vertebral body image. So here, just a couple of examples of some additional non EVAR/FEVAR/TEVAR applications. This is, these are some cases
of internal iliac embolization, aortoiliac occlusion crossing, standard EVAR, complex EVAR. And I think then, that the final thing that I'd like to talk about is the use with C-arm, which is think is really, extremely important.
Has the potential to make a very big difference. All of us in our larger OR suites, know that we are short on hybrid availability, and yet it's difficult to get our institutions to build us another hybrid room. But if you could use a high quality 3D fusion imaging
with a high quality C-arm, you really expand your endovascular capability within the operating room in a much less expensive way. And then if you look at another set of circumstances where people don't have a hybrid room at all, but do want to be able to offer standard EVAR
to their patients, and perhaps maybe even basic FEVAR, if there is such a thing, and we could use good quality imaging to do that in the absence of an actual hybrid room. That would be extremely valuable to be able to extend good quality care
to patients in under-served areas. So I just was mentioning that we can use this and Tara Mastracci was talking yesterday about how happy she is with her new room where she has the use of CYDAR and an excellent C-arm and she feels that she is able to essentially run two rooms,
two hybrid rooms at once, using the full hybrid room and the C-arm hybrid room. Here's just one case of Dr. Goverde's. A vascular case that he did on a mobile C-arm with aortoiliac occlusive disease and he places kissing stents
using a CYDAR EV and a C-arm. And he used five mils of iodinated contrast. So let's talk about a little bit of data. This is out of Blain Demorell and Tara Mastrachi's group. And this is use of fusion technology in EVAR. And what they found was that the use of fusion imaging
reduced air kerma and DSA runs in standard EVAR. We also looked at our experience recently in EVAR and FEVAR and we compared our results. Pre-availability of image based fusion CT and post image based fusion CT. And just to clarify,
we did have the mechanical product that Phillip's offers, but we abandoned it after using it a half dozen times. So it's really no image fusion versus image fusion to be completely fair. We excluded patients that were urgent/emergent, parallel endographs, and IBEs.
And we looked at radiation exposure, contrast use, fluoro time, and procedure time. The demographics in the two groups were identical. We saw a statistically significant decrease in radiation dose using image based fusion CT. Statistically a significant reduction in fluoro time.
A reduction in contrast volume that looks significant, but was not. I'm guessing because of numbers. And a significantly different reduction in procedure time. So, in conclusion, image based 3D fusion CT decreases radiation exposure, fluoro time,
and procedure time. It does enable 3D overlays in all X-Ray sets, including mobile C-arm, expanding our capabilities for endovascular work. And image based 3D fusion CT has the potential to reduce costs
and improve clinical outcomes. Thank you.
- Thank you very much (mumbling) and to the chairman. Good afternoon to everybody. We moved immediately to our topic. This is my disclosure. I would like to present you, introduce you, this new stent. They're a really MicroStent. 3.2 French system.
Very, very small, as you can see. And actually, they are available only for retrograde deployment. And very soon, we will have new devices for antegrade deployment. They are made with nitinol.
Two nitinols... Wires, sorry. My mind is, I'm getting older. Two nitinol wire, and they behave exactly as small supera. I can introduce you the case. That is a gentleman with a previous first toe amputation,
non-healing, and I previously recanalized the one month before posterior tibial artery, but this is a patient with a small artery disease. So, you can see here, the angio, this is a CO2 angio. We have a steel patent posterior tibial, but an occlusion, a long occlusion of the anterior tibial.
And you can see how poor is the vascularization in the foot. Of course, this time, the surgeon asked me to try to recanalize the anterior tibial artery, and for us, it became the new target. You can see how difficult is the progression of the wire in the middle of this black calcium
is a very severe calcificated patient. We achieve the rupture of the Asashi Astato 20 wire. So, it was fortunately, we didn't close the tip. We could remove and change in with an Abbott Command ES hook could fortunately, cross the lesion, but you can see here the balloon cannot advance completely
in this terrible calcified patient. So, we applied this technique. We (mumbling) the antegrade wire into a needle. You can see here the advancement of the wire out of the needle. And when we have in our hand the tip of the antegrade wire,
we can pull a little bit the wire in order to achieve the excess. And we can easily pull the system we have. So, after this phase, we can succeed in have a distal access. May I have the audio?
Yeah. There is no audio volume? Okay, so we achieve the retrograde. At full, that was the key. So, the balloon can come with the wire. But normally, does not work like this.
You have to do this. We put the (mumbling) in the stent (mumbling). So, we put the torca device in the proximal part of the wire very close to the cone of the balloon, the cone wire of the balloon so we can fix the torca device in the proximal part,
as you can see. And now we have one system. We have the wire fixed into the balloon, so if we pull the wire, we can pull the balloon. So, this is a system to advance in the severe calcified legion.
In the 90% of case, it work. Of course, if you fail with this system, I don't know how can we do. But after this manipulation, we could predilate successfully all the anterior tibial artery, and now we have the possibility to aggressively
prepare the vessel as we used to prepare the vessel for when we have severe calcification for a superior stent deployment in SFA. The same we used to do in the tibial vessel when we have this kind of calcification. So, I decided to predilate and dilate all the vessel
three millimeters, and the proximal part with aggressively, with a 3.5 millimeter. And you can see here, after the deployment, after the inflation of the balloon, the result was already good, but there was a residual stenosis at the osteum.
So, we repeated the inflation with a longer inflation with this 3.5 balloon, and the acute result, the acute remodel of the artery was really good. So, now the vessel is very well prepared, and if we think to the destiny of this kind of lesion,
we have to expect a restenosis or reocclusion probably due to the recoiling of the calcium, rather than a hyperplasia, or a myointimal hyperplasia. So, you can see here with a sheetless technique, we can insert from the distal access, this micro stent. It's really very clear.
It's very, very well built and projected, and so we can be very precise in the deployment of the proximal part, and you can see the pull out manipulation, but you can modulate the struts. You can pack when you need the struts in order to improve the resistance to the compression.
And you can see how good is the deployment of the stents in the proximal AT. Of course, the manipulation should be very gentle, and when we have the superposition of the two markers that the stent is completely deployed, and so we can achieve very good scaffold
all the lesion in this patient. So, after the deployment, we had a very nice acute result. Look at how good is the flow. And then we decided to continue interdistality in order to achieve some we can call outflow, which is very important.
But of course, this is a patient. We have Roberto in the panel who can be classified as a no-option patient, because the definition is we have clearly a small artery disease, and all the forefoot has no vessel. Look how difficult it was to achieve a reenter
into the dorsalis pedis after several perforation. This was my thought, but (laughs), it was really a war. At the end, you can see here the flow is exact, in the anterior, is exactly the same speed as in the posterior, but as you can see, in this patient,
the distribution system towards the forefoot is completely failed, so probably, the clinical improvement will be not so fine and not so good. But we before shift to the arterialization, of course, we tried to do our best.
You can see here again, the deployment, how clear is the deployment of the stent at the top at the proximal part of anterior tibial in another case. Very, very smooth after a very good preparation. So, again, the crucial key is to prepare very well the vessel in an aggressive way.
Our experience, we only performed seven cases. They're really very, very calcified. We lost some patient, but we checked three patients that are still patent with one occlusion. It's very encouraging and promising procedure. I really believe in this kind of scaffolding
when we have this kind of calcification. We are going to start a prospective study in order to collect more patient, of course. You can see here, this is one of the first patient perform with a very good result. And you can see here the flow in the doppler ultrasound.
So, thank you very much for your attention, and this is (speech drowned out by applause). - [Male] Thanks. Thanks, Marco. Fantastic, Ian. Any quick questions? Just a quick one.
I mean, in terms of distal preparation, can we use experience like supera with, as you say, slight over-dilating to allow it to sit unconstrained? - [Marco] Yeah, in effect, we have to try to oversize the vessel.
As Roberto used to say, the size is important, especially in below the knee. One of the main reasons of the failure of the global impact study was the undersizing of the angioplasty they perform. And when we have this kind of calcification,
of course, we have to try to crack the calcium in some way, and we have, of course, only balloon because it's difficult to think that an atherectomy device can cross this kind of lesion. So, we try to step-by-step to increase the size of the balloon and the pressure,
of course, in order to crack. And probably, probably could be one option for a better patency in this kind of patient. - [Male] Perfect. Just a quick question, Marco. Do you use a one-to-one ratio of this stent
with the (mumbling) vessel diameter? - [Marco] Yeah. - [Male] Or you use an-- - [Marco] Yes, in this case, we deploy the 3.5 millimeter stent after the 3.5 millimeter balloon angiopathy.
Of course, 3.5, it's a quite huge balloon for the proximal AT. Despite in some patient, we have to use this size of the balloon. - [Male] Okay, thanks, thanks very much, Marco.
- [Narrator] Good morning everyone. Again, thank you Dr. Veith for inviting me for this legendary meeting. I just love your meeting, thank you very much. Here you have my disclosures, I have said that the T-Branch device from Cook is not commercialized in the US
but it is in South America, now it's in Europe. Our presentation today is based in our article published German Vascular Therapy last year in August, Advanced technical considerations for implanting the T-branch off the shelf.
Branches stent-graft to treat Thoracoabdominal Aneurysms. I'm sure most of you already know this device. It's a off the shelf device from Cook. It has 202 millimeters in length. The proximal stent is 34 millimeters, the distal stent is 18 millimeters.
Of course, it has also four downward branch, so you have to adapt the anatomy of your patient and then to use this device in many situations. Here is a simple example, you can use this device in perirenal or superrenal aneurysms type 4. Just cutting one or two of the proximal stents.
Just be aware to (mumbles) the device in the (mumbles). So you can avoid the migration of the device. That's a good way to diminish the risks of paraplegia for you patient. The same way you can now cut the distal portion one or two stents, so and in cases you have
a previous device, you can pipe one in the leak, is we can show in cases, maxes lights, you can use this device. Also, the second component to anybody of the device, the bifurcated component can be cut. You can cut the proximal stents, you can cut
the distal stents, you can make that straight graft. So just like that, use it in many circumstances. And this is one of the maneuvers we use very often. We call that device driven by the sheath because you do a through and through wire and then you put that set the nose of our device
inside the sheath that come from the arm. So it helps by the avoid your device to touch the aort wall or even devices previously inserted. And also allow you to rotate the device to a correct position. Another maneuver is snare-ride technique that
we have already described in the Journal Endovascular Therapy last year. It's a very simple way so we can bring from the femoral access, we can bring the snare inside the one artery and that snare can capture a wire come from the arm, so we can
hold the position inside the target vessel. Here, an example that you can see all those maneuvers. This patient has a previous I-stent surgery and then the device that is probably the false lumen all the vessels come from this true lumen, which is secluded like capsule decortication.
They have minimal aortic communication. They've going to seen more details in the next slides. So here you can see the case that is a communication close to the celiac track and then is stuck. And then you have another communication, the intrarenal aort are very thin.
So here is a draw, you can see the first challenge was could we move a sheath, 12 branch sheath across the (mumbles) in the thin aorta and put that in the thin aorta, so without that, we could not do the case. We start the case doing that and as you can see,
we see that it was possible to do that, so we continue in the case. Following are challenges you will face was would we be able to cross this aort, very thin channel and to go there, to put the device here, and then to put the t-branch device to
all the branches from this true lumen. So here is our study, our plan was if you cross that communication, we put a t-branch here and used the celiac branch to TAAAs. Left renal artery, the celiac branch, the mysentary to branch the celiac artery, the left renal branch
to the mysentary artery and then right renal branch to right renal branch. So, that proves to be feasible. We could graft that communication and that adversary straight device to start the (cuts off). So here you see that the things
happened exactly as we planned it. The celiac was done by the SMA branch, the SMA done by the left renal, and the right renal by the right renal. At that point, we consider the game over. (cuts off) who could try the
celiac branch to the left renal. The angle was not preferable, so we come from the femoral artery in have access to left renal and open (mumbles) there and the diverse that wire should be put inside the left renal. Here you see the maneuver completed.
We advanced and hold the stent so we can have this branch also done. Here, you have a closed view of the left renal branch done by the celiac branch of the device. And now we have the final result of the branch done. How the bifurcate the device of completely
excluding the false movement of this complex dissection. So to illustrate this presentation, I bring you the control, one week control of this patient and could we fold the breasts where (mumbles) did it in the dissection, totally excluded from the circulation.
So, in conclusion ladies and gentlemen, I would say that the use of the branched stent-grafts in the treatment of Thoracoabdominal use is proven feasible, safe, and the off-the-shelf multibranched t-branch can be used in both urgent and elective scenarios.
Employing adjunctive maneuvers can increase the anatomic suitability of rience, these techniques have increased the applicability to 80 percent of the cases, included dissections of the small lumen.
I want to thank you all for your kind attention. Thank you, again, Frank for accepting my talk recorded. And I'm very pleased to answer questions by email or WhatsApp as you can see, this is live. Thank you very much.
- 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 for asking me to speak. Thank you Dr Veith. I have no disclosures. I'm going to start with a quick case again of a 70 year old female presented with right lower extremity rest pain and non-healing wound at the right first toe
and left lower extremity claudication. She had non-palpable femoral and distal pulses, her ABIs were calcified but she had decreased wave forms. Prior anterior gram showed the following extensive aortoiliac occlusive disease due to the small size we went ahead and did a CT scan and confirmed.
She had a very small aorta measuring 14 millimeters in outer diameter and circumferential calcium of her aorta as well as proximal common iliac arteries. Due to this we treated her with a right common femoral artery cutdown and an antegrade approach to her SFA occlusion with a stent.
We then converted the sheath to a retrograde approach, place a percutaneous left common femoral artery access and then placed an Endologix AFX device with a 23 millimeter main body at the aortic bifurcation. We then ballooned both the aorta and iliac arteries and then placed bilateral balloon expandable
kissing iliac stents to stent the outflow. Here is our pre, intra, and post operative films. She did well. Her rest pain resolved, her first toe amputation healed, we followed her for about 10 months. She also has an AV access and had a left arterial steel
on a left upper extremity so last week I was able to undergo repeat arteriogram and this is at 10 months out. We can see that he stent remains open with good flow and no evidence of in stent stenosis. There's very little literature about using endografts for occlusive disease.
Van Haren looked at 10 patients with TASC-D lesions that were felt to be high risk for aorta bifem using the Endologix AFX device. And noted 100% technical success rate. Eight patients did require additional stent placements. There was 100% resolution of the symptoms
with improved ABIs bilaterally. At 40 months follow up there's a primary patency rate of 80% and secondary of 100% with one acute limb occlusion. Zander et all, using the Excluder prothesis, looked at 14 high risk patients for aorta bifem with TASC-C and D lesions of the aorta.
Similarly they noted 100% technical success. Nine patients required additional stenting, all patients had resolution of their symptoms and improvement of their ABIs. At 62 months follow up they noted a primary patency rate of 85% and secondary of 100
with two acute limb occlusions. The indications for this procedure in general are symptomatic patient with a TASC C or D lesion that's felt to either be a high operative risk for aorta bifem or have a significantly calcified aorta where clamping would be difficult as we saw in our patient.
These patients are usually being considered for axillary bifemoral bypass. Some technical tips. Access can be done percutaneously through a cutdown. I do recommend a cutdown if there's femoral disease so you can preform a femoral endarterectomy and
profundaplasty at the same time. Brachial access is also an alternative option. Due to the small size and disease vessels, graft placement may be difficult and may require predilation with either the endograft sheath dilator or high-pressure balloon.
In calcified vessels you may need to place covered stents in order to pass the graft to avoid rupture. Due to the poor radial force of endografts, the graft must be ballooned after placement with either an aortic occlusion balloon but usually high-pressure balloons are needed.
It usually also needs to be reinforced the outflow with either self-expanding or balloon expandable stents to prevent limb occlusion. Some precautions. If the vessels are calcified and tortuous again there may be difficult graft delivery.
In patients with occluded vessels standard techniques for crossing can be used, however will require pre-dilation before endograft positioning. If you have a sub intimal cannulation this does put the vessel at risk for rupture during
balloon dilation. Small aortic diameters may occlude limbs particularly using modular devices. And most importantly, the outflow must be optimized using stents distally if needed in the iliac arteries, but even more importantly, assuring that you've
treated the femoral artery and outflow to the profunda. Despite these good results, endograft use for occlusive disease is off label use and therefor not reimbursed. In comparison to open stents, endograft use is expensive and may not be cost effective. There's no current studies looking
into the cost/benefit ratio. Thank you.
- Our group has looked at the outcomes of patients undergoing carotid-subclavian bypass in the setting of thoracic endovascular repair. These are my obligatory disclosures, none of which are relevant to this study. By way of introduction, coverage of the left subclavian artery origin
is required in 10-50% of patients undergoing TEVAR, to achieve an adequate proximal landing zone. The left subclavian artery may contribute to critical vascular beds in addition to the left upper extremity, including the posterior cerebral circulation,
the coronary circulation if a LIMA graft is present, and the spinal cord, via vertebral collaterals. Therefore the potential risks of inadequate left subclavian perfusion include not only arm ischemia, but also posterior circulation stroke,
spinal cord ischemia, and coronary insufficiency. Although these risks are of low frequency, the SVS as early as 2010 published guidelines advocating a policy of liberal left subclavian revascularization during TEVAR
requiring left subclavian origin coverage. Until recently, the only approved way to maintain perfusion of the left subclavian artery during TEVAR, with a zone 2 or more proximal landing zone, was a cervical bypass or transposition procedure. As thoracic side-branch devices become more available,
we thought it might be useful to review our experience with cervical bypass for comparison with these newer endovascular strategies. This study was a retrospective review of our aortic disease database, and identified 112 out of 579 TEVARs
that had undergone carotid subclavian bypass. We used the standard operative technique, through a short, supraclavicular incision, the subclavian arteries exposed by division of the anterior scalene muscle, and a short 8 millimeter PTFE graft is placed
between the common carotid and the subclavian arteries, usually contemporaneous with the TEVAR procedure. The most important finding of this review regarded phrenic nerve dysfunction. To exam this, all pre- and post-TEVAR chest x-rays were reviewed for evidence of diaphragm elevation.
The study population was typical for patients undergoing TEVAR. The most frequent indication for bypass was for spinal cord protection, and nearly 80% of cases were elective. We found that 25 % of patients had some evidence
of phrenic nerve dysfunction, though many resolved over time. Other nerve injury and vascular graft complications occurred with much less frequency. This slide illustrates the grading of diaphragm elevation into mild and severe categories,
and notes that over half of the injuries did resolve over time. Vascular complications were rare, and usually treated with a corrective endovascular procedure. Of three graft occlusions, only one required repeat bypass.
Two pseudoaneurysms were treated endovascularly. Actuarial graft, primary graft patency, was 97% after five years. In summary then, the report examines early and late outcomes for carotid subclavian bypass, in the setting of TEVAR. We found an unexpectedly high rate
of phrenic nerve dysfunction postoperatively, although over half resolved spontaneously. There was a very low incidence of vascular complications, and a high long-term patency rate. We suggest that this study may provide a benchmark for comparison
with emerging branch thoracic endovascular devices. Thank you.
- Thank you. Here are my disclosures. Our preferred method for zone one TAVR has evolved to a carotid/carotid transposition and left subclavian retro-sandwich. The technique begins with a low transverse collar incision. The incision is deepened through the platysma
and subplatysmal flaps are then elevated. The dissection is continued along the anterior border of the sternocleidomastoid entering the carotid sheath anteromedial to the jugular vein. The common carotid artery is exposed
and controlled with a vessel loop. (mumbling) The exposure's repeated for the left common carotid artery and extended as far proximal to the omohyoid muscle as possible. A retropharyngeal plane is created using blunt dissection
along the anterior border of the cervical vertebra. A tunneling clamp is then utilized to preserve the plane with umbilical tape. Additional vessel loops are placed in the distal and mid right common carotid artery and the patient is systemically anticoagulated.
The proximal and distal vessel loops are tightened and a transverse arteriotomy is created between the middle and distal vessel loops. A flexible shunt is inserted and initially secured with the proximal and middle vessel loops. (whistling)
It is then advanced beyond the proximal vessel loop and secured into that position. The left common carotid artery is then clamped proximally and distally, suture ligated, clipped and then transected. (mumbling)
The proximal end is then brought through the retropharyngeal tunnel. - [Surgeon] It's found to have (mumbles). - An end-to-side carotid anastomosis is then created between the proximal and middle vessel loops. If preferred the right carotid arteriotomy
can be made ovoid with scissors or a punch to provide a better shape match with the recipient vessel. The complete anastomosis is back-bled and carefully flushed out the distal right carotid arteriotomy.
Flow is then restored to the left carotid artery, I mean to the right carotid artery or to the left carotid artery by tightening the middle vessel loop and loosening the proximal vessel loop. The shunt can then be removed
and the right common carotid artery safely clamped distal to the transposition. The distal arteriotomy is then closed in standard fashion and flow is restored to the right common carotid artery. This technique avoids a prosthetic graft
and the retropharyngeal space while maintaining flow in at least one carotid system at all times. Once, and here's a view of the vessels, once hemostasis is assured the platysma is reapproximated with a running suture followed by a subcuticular stitch
for an excellent cosmetic result. Our preferred method for left subclavian preservation is the retro-sandwich technique which involves deploying an initial endograft just distal to the left subclavian followed by both proximal aortic extension
and a left subclavian covered stent in parallel fashion. We prefer this configuration because it provides a second source of cerebral blood flow independent of the innominate artery
and maintains ready access to the renovisceral vessels if further aortic intervention is required in the future. Thank you.
- These are my disclosures. So central venous access is frequently employed throughout the world for a variety of purposes. These catheters range anywhere between seven and 11 French sheaths. And it's recognized, even in the best case scenario, that there are iatrogenic arterial injuries
that can occur, ranging between three to 5%. And even a smaller proportion of patients will present after complications from access with either a pseudoaneurysm, fistula formation, dissection, or distal embolization. In thinking about these, as you see these as consultations
on your service, our thoughts are to think about it in four primary things. Number one is the anatomic location, and I think imaging is very helpful. This is a vas cath in the carotid artery. The second is th
how long the device has been dwelling in the carotid or the subclavian circulation. Assessment for thrombus around the catheter, and then obviously the size of the hole and the size of the catheter.
Several years ago we undertook a retrospective review and looked at this, and we looked at all carotid, subclavian, and innominate iatrogenic injuries, and we excluded all the injuries that were treated, that were manifest early and treated with just manual compression.
It's a small cohort of patients, we had 12 cases. Eight were treated with a variety of endovascular techniques and four were treated with open surgery. So, to illustrate our approach, I thought what I would do is just show you four cases on how we treated some of these types of problems.
The first one is a 75 year-old gentleman who's three days status post a coronary bypass graft with a LIMA graft to his LAD. He had a cordis catheter in his chest on the left side, which was discovered to be in the left subclavian artery as opposed to the vein.
So this nine French sheath, this is the imaging showing where the entry site is, just underneath the clavicle. You can see the vertebral and the IMA are both patent. And this is an angiogram from a catheter with which was placed in the femoral artery at the time that we were going to take care of this
with a four French catheter. For this case, we had duel access, so we had access from the groin with a sheath and a wire in place in case we needed to treat this from below. Then from above, we rewired the cordis catheter,
placed a suture-mediated closure device, sutured it down, left the wire in place, and shot this angiogram, which you can see very clearly has now taken care of the bleeding site. There's some pinching here after the wire was removed,
this abated without any difficulty. Second case is a 26 year-old woman with a diagnosis of vascular EDS. She presented to the operating room for a small bowel obstruction. Anesthesia has tried to attempt to put a central venous
catheter access in there. There unfortunately was an injury to the right subclavian vein. After she recovered from her operation, on cross sectional imaging you can see that she has this large pseudoaneurysm
coming from the subclavian artery on this axial cut and also on the sagittal view. Because she's a vascular EDS patient, we did this open brachial approach. We placed a stent graft across the area of injury to exclude the aneurism.
And you can see that there's still some filling in this region here. And it appeared to be coming from the internal mammary artery. We gave her a few days, it still was patent. Cross-sectional imaging confirmed this,
and so this was eventually treated with thoracoscopic clipping and resolved flow into the aneurism. The next case is a little bit more complicated. This is an 80 year-old woman with polycythemia vera who had a plasmapheresis catheter,
nine French sheath placed on the left subclavian artery which was diagnosed five days post procedure when she presented with a posterior circulation stroke. As you can see on the imaging, her vertebral's open, her mammary's open, she has this catheter in the significant clot
in this region. To manage this, again, we did duel access. So right femoral approach, left brachial approach. We placed the filter element in the vertebral artery. Balloon occlusion of the subclavian, and then a stent graft coverage of the area
and took the plasmapheresis catheter out and then suction embolectomy. And then the last case is a 47 year-old woman who had an attempted right subclavian vein access and it was known that she had a pulsatile mass in the supraclavicular fossa.
Was noted to have a 3cm subclavian artery pseudoaneurysm. Very broad base, short neck, and we elected to treat this with open surgical technique. So I think as you see these consults, the things to factor in to your management decision are: number one, the location.
Number two, the complication of whether it's thrombus, pseudoaneurysm, or fistula. It's very important to identify whether there is pericatheter thrombus. There's a variety of techniques available for treatment, ranging from manual compression,
endovascular techniques, and open repair. I think the primary point here is the prevention with ultrasound guidance is very important when placing these catheters. Thank you. (clapping)
- Few aspects of vascular surgery are more controversial than the management of neurogenic TOS as you heard earlier from Dr. Illig. I will propose that recurrent neurogenic TOS and persistent neurogenic TOS are even more of a challenge to deal with. Persistent neurogenic TOS
occurs in 10 to 15% of patients, and it's really the individual who fails to show any improvement following decompression. Recurrent, 15 to 30% of individuals who have some degree of partial or complete relief after the initial decompression.
This may be insidious or acute, and most often occurs somewhere within a two-year time frame. It could be a missed original diagnosis. Or it may be a secondary insult, a new stretch injury to the plexus,
incomplete rib resection, ectopic bands, scar tissue formation around the plexus, or pec minor syndrome. Pec minor syndrome is a frequent cause of recurrent and/or persistent neurogenic symptoms.
Its co-existence is over 50% of patients with neurogenic TOS. Sanders recognized in 2003 that pec minor causes the majority of recurrent neurogenic TOS symptoms. What is it?
Well the pec minor originates in the second, third, fourth, and fifth ribs, inserting on the coracoid process, which is part of the scapula. Muscle hypertrophy, spasm, and fibrosis will constrict those structures underneath,
which would be the axial artery vein and posterior to that will be your plexus. This was first described in '45 by Wright. Lord and Stone did five decompressions for what they defined as "hyperabduction syndrome." It was lost at some point,
rediscovered by Thomas then Doctor Sanders in 2004, who studied it prolifically, defined it as a sub-set of neurogenic TOS. There's a plethora of literature in this present day and age supporting pec minor syndrome.
Etiology: majority of people have trauma, most often in motor vehicle accident with a whiplash type of injury. Repetitive shoulder strain and spontaneous events can occur, inducing hyper-induction of the shoulder. Clinical symptoms are similar
between neurogenic and pec minor: weakness, pain in the neck, clavicular, anterior chest wall, trapezius region and then paresthesias, most often in the ulnar distribution. Isolated pec minor does happen. Typically these individuals
have fewer head and neck symptoms. And you'll notice the intensity of symptoms are significantly less. On your examination it's your standard TOS examination. Unfortunately provocative maneuvers are not as rewarding. You'll find that with isolated pec minor,
these individuals have fewer head and neck symptoms, typically with rotation, tilt, scalene compression. There's nothing really to see. But they do have point tenderness over the infraclavicular region, directly on top of the pec minor.
And you'll notice that with contraction of the pec major, the symptoms will be minimized. Sanders noted the three most common findings with pec minor syndrome are: tenderness to palpation in the subcoracoid space, ULTT and EAST.
You'll notice that in some of these patients who do have persistent or recurrent symptoms, quite likely, pec minor tenderness was missed in the original diagnosis. A thorough history and physical certainly is beneficial. Unfortunately there's no test or exam
that is pathognomonic for this. Appropriate imaging should be completed to rule out other pathology. And then a selective pec minor muscle block not a plexus block, but a minor block, a muscle minor block,
should be considered. EMG testing has mixed results. When you look at your muscle block, typically done with a baseline examination, you'll then inject lidocaine 4 cc with ultrasound guidance 45 degree angle to avoid dropping in the lung.
Inject in a two to three centimeter area. And what you're looking for is resolution of your tenderness, improvement of your symptoms, at rest and with provocative maneuvers. For those ones who have an unsuccessful block
you may want to consider repeating it, or consider performing a scalene block. For those individuals that do have pec minor syndrome, conservative therapy, which is range-of-motion and stretching, tends to work well, 50% resolution in eight-week window.
For those individuals who fail pec minor tenotomy, low-risk out-patient procedure, relatively quick recovery time. A variety of approaches have been defined in the literature. Here's one approach with a patient
previously undergoing neurogenic decompression with a superclavicular approach, this is the anterior axillary approach, with a two to three centimeter vertical incision in the anterior axillary line. The subcutaneous divide at the pec fascia
is open and the muscle is elevated with a Deaver retractor. You'll trace this up to the coracoid process, and with that being the case, you'll transect two to three centimeters of the pectoralis minor muscle,
and then release any fascial bands or accessory muscle around the neurovascular bundle. These patients have done well. With isolated tenotomy you'll see that there's an improvement anywhere from 90 to 100%. However, you need to take into consideration
a good number of these people have combined neurogenic TOS and pec minor syndrome. And with that being the case, the success may be a little bit less. So in summary, pec minor syndrome is a frequent cause
of recurrent or persistent neurogenic TOS. Isolated pec minor tends to have fewer head and neck symptoms. Diagnosis is aided with a block. And tenotomy appears to be safe and effective. Thank you.
- [Speaker] Good morning everybody thanks for attending the session and again thanks for the invitation. These are my disclosures. I will start by illustrating one of the cases where we did not use cone beam CT and evidently there were numerous mistakes on this
from planning to conducting the case. But we didn't notice on the completion of geography in folding of the stent which was very clearly apparent on the first CT scan. Fortunately we were able to revise this and have a good outcome.
That certainly led to unnecessary re intervention. We have looked at over the years our usage of fusion and cone beam and as you can see for fenestrated cases, pretty much this was incorporated routinely in our practice in the later part of the experience.
When we looked at the study of the patients that didn't have the cone beam CT, eight percent had re intervention from a technical problem that was potentially avoidable and on the group that had cone beam CT, eight percent had findings that were immediately revised with no
re interventions that were potentially avoidable. This is the concept of our GE Discovery System with fusion and the ability to do cone beam CT. Our protocol includes two spins. First we do one without contrast to evaluate calcification and other artifacts and also to generate a rotational DSA.
That can be also analyzed on axial coronal with a 3D reconstruction. Which essentially evaluates the segment that was treated, whether it was the arch on the arch branch on a thoracoabdominal or aortoiliac segment.
We have recently conducted a prospective non-randomized study that was presented at the Vascular Annual Meeting by Dr. Tenario. On this study, we looked at findings that were to prompt an immediate re intervention that is either a type one
or a type 3 endoleak or a severe stent compression. This was a prospective study so we could be judged for being over cautious but 25% of the procedures had 52 positive findings. That included most often a stent compression or kink in 17% a type one or three endoleak
in 9% or a minority with dissection and thrombus. Evidently not all this triggered an immediate revision, but 16% we elected to treat because we thought it was potentially going to lead to a bad complication. Here is a case where on the completion selective angiography
of the SMA this apparently looks very good without any lesions. However on the cone beam CT, you can see on the axial view a dissection flap. We immediately re catheterized the SMA. You note here there is abrupt stop of the SMA.
We were unable to catheterize this with a blood wire. That led to a conversion where after proximal control we opened the SMA. There was a dissection flap which was excised using balloon control in the stent as proximal control.
We placed a patch and we got a good result with no complications. But considerably, if this patient was missed in the OR and found hours after the procedure he would have major mesenteric ischemia. On this study, DSA alone would have missed
positive findings in 34 of the 43 procedures, or 79% of the procedures that had positive findings including 21 of the 28 that triggered immediate revision. There were only four procedures. 2% had additional findings on the CT
that were not detectable by either the DSA or cone beam CT. And those were usually in the femoro puncture. For example one of the patients had a femoro puncture occlusion that was noted immediately by the femoro pulse.
The DSA accounts for approximately 20% of our total radiation dose. However, it allows us to eliminate CT post operatively which was done as part of this protocol, and therefore the amount of radiation exposed for the patient
was decreased by 55-65% in addition to the cost containment of avoiding this first CT scan in our prospective protocol. In conclusion cone beam CT has allowed immediate assessment to identify technical problems that are not easily detectable by DSA.
These immediate revisions may avoid unnecessary re interventions. What to do if you don't have it? You have to be aware that this procedure that are complex, they are bound to have some technical mistakes. You have to have incredible attention to detail.
Evidently the procedures can be done, but you would have to have a low threshold to revise. For example a flared stent if the dilator of the relic gleam or the dilator of you bifurcated devise encroach the stent during parts of the procedure. Thank you very much.
- Thank you very much and I would like to thank Dr. Veit for the kind invitation, this is really great meeting. Those are my disclosures. Percutaneous EVAR has been first reported in the late 1990's. However, for many reasons it has not been embraced
by the vascular community, despite the fact that it has been shown that the procedure can be done under local anesthesia and it decreases OR time, time to ambulation, wound complication and length of stay. There are three landmark papers which actually change this trend and make PEVAR more popular.
All of these three papers concluded that failure or observed failure of PEVAR are observed and addressed in the OR which is a key issue. And there was no late failures. Another paper which is really very prominent
is a prospective randomize study that's reported by Endologix and published in 2014. Which revealed that PEVAR closure of the arteriotomy is not inferior to open cut down. Basically, this paper also made it possible for the FDA to approve the device, the ProGlide device,
for closure of large bore arteriotomies, up to 26 in the arterial system and 29 in the venous system. We introduced percutaneous access first policy in our institution 2012. And recently we analyzed our results of 272 elective EVAR performed during the 2012 to 2016.
And we attempted PEVAR in 206 cases. And were successful in 92% of cases. But the question was what happened with the patient that failed PEVAR? And what we found that was significantly higher thrombosis, vessel thrombosis,
as well as blood loss, more than 500 cc in the failed PEVAR group. Similarly, there was longer operative time and post-operative length of stay was significantly longer. However, in this relatively small group of patients who we scheduled for cut-down due to different reasons,
we found that actually there was no difference between the PEVAR and the cut-down, failed PEVAR and cut-down in the terms of blood loss, thrombosis of the vessel, operative time and post-operative length of stay. So what are the predictors of ProGlide failure?
Small vessel calcification, particularly anterior wall calcification, prior cut-down and scarring of the groin, high femoral bifurcation and use of large bore sheaths, as well as morbid obesity. So how can we avoid failures?
I think that the key issue is access. So we recommend that all access now or we demand from our fellow that when we're going to do the operation with them, cut-down during fluoroscopy on the ultra-sound guidance, using micropuncture kits and access angiogram is actually mandatory.
But what happened when there is a lack of hemostasis once we've deployed two PEVARs? Number one, we try not to use more than three ProGlide on each side. Once the three ProGlide failed we use the angioseal. There's a new technique that we can have body wire
and deployed angioseal and still have an access. We also developed a technique that we pack the access site routinely with gelfoam and thrombin. And also we use so-called pull and clamp technique, shown here. Basically what it is, we pull the string of the ProGlide
and clamp it on the skin level. This is actually a very very very good technique. So in conclusion, PEVAR first approach strategy successful in more than 90% of cases, reduced operative time and postoperative length of stay, the failure occurred more commonly when the PEVAR
was completed outside of IFU, and there was no differences in outcome between failed PEVAR and planned femoral cut-down. Thank you.
- [Presenter] Thank you very much. So this is a case where, recently, we found it very convenient for our patients when we do good vessel preparation with, let's say, aggressive balloon dilatation to anaesthetize the whole artery or the whole length, we have several options open to do this and this is the recorded case where we
use here a special balloon to do this the Bullfrog Device. So this is a 76 old patient we have done this case just last week as a live case for VIVA ulceration forefoot right but also severe claudication for longer time
short walking distance, ABI low, a severely calcified SFA, total occlusion on the right side and here you can see the risk factors. So before I start this is the device which were using here for the local anesthesia of the whole artery.
The Bullfrog Device, so a balloon with a needle here inside the foldings when you open up the balloon the needle is pressed into the artery, into the adventitia or perivascular tissue and then you can inject here actually whatever you want.
It has been trialed in the DANCE trial injecting Cortisone, Dexamethasone into the artery as a phase but also in below the knee arteries. But here's now the case. Can we have volume please? - [Surgeon] In fact, it looks a little bit different to
what we thought it would be so we have seen clearly a lot of calcium but here the proximal part looks to me actually a little bit thrombotic although complains we had no acute onset. We can see the proximal part is not that calcified so I would actually call this rather severely calcified
and seeing this, I would say, well in our lab a superior case. You can however also see more distal, some more disease. This is more a stenotic and potentially, if we can we would only maybe only treat this with a drug called balloon.
The outflow is very slow and posterior at the end is the main artery is also very much to this disease and the prosterior is actually the only one it will go down. Thought it would be relatively a complex case to recannalise with wire because of this calcification. Took an O18 wire, command 18
and the wire just flew thorough. It was a little bit surprising. We want to pre-dilate now. We want to do here some kind of local anesthesia to that artery. And in a lady with this severe calcification
we always, I mean expect quite some pain when we balloon here especially when we aggressively balloon to prepare fore superior stents and we have since some years something like a standard to really take needle down here to the plaque and give local anesthesia here around that plaque to make it
completely pain free, this treatment. So at the beginning we did this with X-ray control to take the needle down then we change to ultrasound guided puncture which is also actually very nice. Well, recently that's what we want to show you here,
we actually took the Bullfrog Device to inject local anesthesia into the arterial wall and found that actually very nice. Extremely easy and we don't have to puncture the skin above that artery several times which is also of course sometimes, I would especially in female patients,
not the nicest thing to do. - [Caller] I just caught up on where you are right now and if you have concerns about thrombosis, is there a conversation you had about some embolisation protection... - [Surgeon] Pre-dilated now a little bit
also for that Bullfrog Device to get easily through this severe calcium here with 3 mm balloon which was, patient fell but of course, 3 mm was not too painful. I think that 3 mm pre-dilation may also help me to identify thrombus.
- [Presenter] This is spider filter 7 mm. - [Surgeon] Embolisation. So now I have the Bullfrog Device here to go down and as I just heard, I mean calcium could be a concern for Bullfrog Device to be capable to bring the needle through the calcium.
- [Caller] Tell us a little bit about the concentration you're using there and how you'll determine how far apart each of your injections are going to be - [Surgeon] Yeah. - [Caller] Were you just visualizing that depending on the calcification or what's the parameters
that you're using there under. - [Surgeon] Well, it's actually as we have done it in the trials that you mix what you want to inject here into the arterial wall with some contrast. So, if we have 2% Lidocaine, 20 mm plus 4 mm of contrast and that enables me to really see whether
the needle is going into the arterial wall or whether the injection is into the artery. So we're going to inflate now, the balloon. You can see those two markers here. We'll go little close here now, which is now two markers direct.
Maybe you can also see that small needle here getting out. Just a moment. I think you can see that small needle if it's not calcium. Just a moment. Okay, now I load here maybe.. - [Caller] So this is, what 30, 34 gauge needle? - [Surgeon] Yes. Okay, let's inject here a little bit.
And as you can see here, it goes into the surrounding. I think quite nicely and you see it's spreads also proximal and distal and that means I don't, I can deflate now of course and to an area where I do not see it repull. Well the repull was not too strong infact.
That's here, please. - [Caller] Now is she having any pain with this pull of inflation or we'll she notice some of the earlier? - [Surgeon] Absolutely no sensation here of that balloon inflation.
Let's see. So this here, I think again goes very nicely into the arterial wall, as you can see it spreads distally a little bit. In fact, my first case I did with Bullfrog in the SFA was a case where there was actually no calcium but still extremely painful for the patient
that of course worked very nicely. And the second case however I had a real, extremely calcified SFA which was however in fact very eccentric long occlusion and the wire of course went subintimal or down beside the plaque, between adventitia which was not calcified in the plaque
and it was very easy to direct the needle to the non-calcified area and even though it was very calcified, it was very easy to give a successful administration of local into every area. So, here of course, it's a little bit different. This is now a circumferential calcification,
wire went through intraluminally. - [Caller] So, you're starting with you're intention to - [Presenter] So let me stop here. Just quickly. So maybe, Steven, there's several ways to do local anesthesia to the whole artery. I know you're doing something different.
Michael, for example, he injects some Lidocaine into the artery. I found it sometimes helpful but it may make pain little better but they are not completely pain free. You're doing some local injection there around the femoral nerve in the groin.
Can you report how this works? - [Steven] Yup, so Andrea you're right. I think as we all know, the strategy behind calcified lesion is adequate vessel preparations. So, the way we do it is to inject the mixture of Lidocaine as well as the Bupivacaine,
which is the long acting anesthesia. So, mixture of short acting and long acting and ultra-sound guidance, we look for the femoral nerve which is lateral to the artery and we infuse a 20 to 30 mm volume around the femoral nerve and for the BTK intervention 100% of all our BTK interventions we do a nerve block
at the popliteal level to completely anesthetized the leg below the knee and this allows high pressure angioplasty 24, 26 atmospheres with completely no pain at all. And also no movement because it blocks the sensory and also the motor nerve and the patients recover
with no sequelae. It's quite a common practice for orthopedic surgical procedures so and so forth. But I think the concept of putting a Lidocaine into the adventitial space even within the arterial wall is a very very interesting concept for when other techniques of anesthesia is not available.
I think the Bullfrog Device, you can see it spread. I think it's not, maybe the areas where you inject and it goes, I think it's actually a possibly that adventitia is diffusing very nicely with anesthesia. And I'm just interested that if the patient had any pain at all cause I think in this cause...
- [Presenter] Nothing, no sensation anymore at all. - [Steven] No sensation.. completely. So, I mean do you do it on one side? Two sides? - [Presenter] Actually, only on one side. You have seen it on one injection, it spreads around - [Steven] Spreads around right?
- [Presenter] But it also goes up and down. - [Steven] Yeah. I mean, I'm just curious just looking at this procedure that calcified vessel maybe before the anesthesia, the needle will also help to change the compliance of the calcium by puncturing - [Presenter] Potentially. That requires,
however, severally punctures. (Steven laughs) Let me continue here the case to the end. Just a moment. Hopefully it works. - [Caller] Maybe the stent size you're going to use. Maybe go to six...
- [Surgeon] I do in fact, in this extremely calcified arteries in men often go because it's absolutely pain free to a 6.5. However, this lady here, I think it's rather small arteries unfortunately, I think the maximum would be 5.5. The middle portion, I had the impression that maybe
balloon inflation was not complete, the balloon opening was not complete and the severe calcium would in fact go - [Presenter] So, six, 40, 20 atmospheres have no sensation at all. Nothing. - [Surgeon] I think we can come here without stents
so therefore, I continue here... - Why you done today use this drug a called balloon? - [Presenter] Distal, you use drug called balloon, but more proximal not. Yes, I started right here where the occlusion ended with the superior stent.
- [Surgeon] We didn't have any problem here to open up the stent here and I think it really looks very regular. Here the calcium, here actually no problem here, had to push the device a little bit in here to stay regular with this stent and here it went out.
Just to show you here that really nearly nominal a little bit stacked when you take the delivery system down, the markers here indicate 150 mm. - [Caller] When I get one that looks that good I'd take the risk... (Surgeon laughs)
I mean this is something what you wouldn't do in studies and there's no limitation of trials but might be at the end of the day - [Presenter] Drug-eluting Eluvia stent proximal - [Caller] ...Which is best stent? Or because you use the areas where the mechanical
requirements are most important and optimize the stent like Supera. And to use the arrowverse scaffolding is important but let's say you don't use heavy calcification drug-eluting device which probably gives you good results for many other reasons
and makes the procedure just easier and precise so at the end of the day it's very meaningful combination in my eye. - [Presenter] Yeah, fine. Thank you. There's some few slices. This is how we started with percutaneous local anesthesia
and the X-ray with a longer needle to go down to the plaque and give it at several areas. Here you can another angulation how the needle goes down to the plaque and we change to ultrasound which is also very nice, no X-ray can see also better how it spreads here, you know where to
puncture the next time to give another local anesthesia. Just two more cases where we used the Bullfrog which were actually nicer than in this case here. Here you can see that really with every injection here you could deliver a nice depull. This case we were doing that was very old lady
with a very fragile artery. I think this was problem. But other cases where really absolutely easy to do this here. Once again the needle which goes in here and again 6 mm balloon. No sensation of pain whereas predilation with 4 mm balloon was extremely painful in this patient.
And then we thought it can not work in calcium because in calcific arteries below the knee we sometimes had problems to get the needle out of the calcium into the adventitia. Here it's different usually it's wire travel eccentrically around the plaque and you can direct this needle here
to other side, not to the calcium but to the other side. So also with extremely calcium where we actually need this most here for, let's say for crack and pave technique, it worked actually very nice here with all the depulls here with a nice result. Thank you.
- Thank you. I'm grateful. It's a great presentation. (Crowd clapping) This is really an innovative idea and for me the best application of the Bullfrog balloon. (Speaker laughs) - [Presenter] But also you could maybe mix it
with local something else... - Because my next question is, are you injecting Lidocaine and Dexamethasone simultaneously? - [Presenter] Haven't done it yet but that would be... - This could be a good idea that you inject Lidocaine and Dexamethasone simultaneously.
- Thank you very much for the privilege of participating in this iconic symposium. I have no disclosures pertinent to this presentation. The Atelier percutaneous endovascular repair for ruptured abdominal aortic aneurysms is a natural evolution of procedural technique due to the success of fully percutaneous endovascular
aortic aneurysm repair in elective cases. This past year, we had the opportunity to publish our data with regard to 30 day outcomes between percutaneous ruptured aneurysm repairs and surgical cutdown repairs utilizing the American College of Surgeons NSQIP database,
which is a targeted database which enrolls about 800 hospitals in the United States, looking at both the univariate and multivariate analyses comparing preoperative demographics, operative-specific variables and postoperative outcomes. There were 502 patients who underwent
ruptured abdominal aortic aneurysms that were included in this review, 129 that underwent percutaneous repair, whereas 373 underwent cutdown repair. As you can see, the majority were still being done by cutdown.
Over the four years, however, there was a gradual increase in the number of patients that were having percutaneous repair used as their primary modality of access, and in fact a more recent stasis has shown to increase up to 50%,
and there certainly was a learning curve during this period of time. Looking at the baseline characteristics of patients with ruptured aneurysms undergoing both modalities, there was not statistically significant difference
with regard to these baseline characteristics. Likewise, with size of the aneurysms, both were of equal sizes. There was no differences with regard to rupture having hypotension, proximal or distal extension of the aneurysms.
What is interesting, however, that the patients that underwent percutaneous repair tended to have regional anesthesia as their anesthesia of choice, rather than that of having a general. Also there was for some unexplained reason
a more significant conversion to open procedures in the percutaneous group as compared to the cutdown group. Looking at adjusted 30-day outcomes for ruptured endovascular aneurysm repairs, when looking at the 30-day mortality,
the operative time, wound complications, hospital length of stay, that was not statistically significant. However, over that four year period of time, there tended to be decreased hospital length of stay as well as decreased wound complications
over four years. So the summary of this study shows that there was an increased use of fully percutaneous access for endovascular repairs for ruptured aneurysms with noninferiority compared to traditional open femoral cutdown approaches.
There is a trending advantage over conventional surgical exposure with decreased access-related complications, as well as decreased hospital length of stay. Now, I'm going to go through some of the technical tips, and this is really going to be focused upon
the trainees in the room, and also perhaps those clinicians who do not do percutaneous access at this time. What's important, I find, is that the utility of duplex ultrasonography, and this is critical to delineate the common
femoral artery access anatomy. And what's important to find is the common femoral artery between the inguinal ligament and this bifurcation to the profunda femoral and superficial femoral arteries. So this is your target area. Once this target area is found,
especially in those patients presenting with ruptured aneurysm, local anesthesia is preferred over general anesthesia with permissive hypotension. This is a critical point that once you use ultrasound, that you'd want to orient your probe to be
90 degrees to the target area and measure the distance between the skin and the top of that artery. Now if you hold that needle at equidistance to that same distance between the skin and the artery and angle that needle at 45 degrees,
this will then allow you to have the proper trajectory to hit the target absolutely where you're imaging the vessel, and this becomes important so you're not off site. Once micropuncture technique is used, it's always a good idea just to use
a quick fluoroscopic imaging to show that your access is actually where you want it to be. If it's not, you can always re-stick the patient again. Once you have the access in place, what can then happen is do a quick angio to show in fact you have reached the target vessel.
This is the routine instructions for use by placing the percutaneous suture-mediated closure system at 45 degree angles from one another, 90 degrees from one another. Once the sheath is in place for ruptured aneurysm, the placement of a ballon occlusion
can be done utilizing a long, at least 12 French sheath so that they'll keep that balloon up in place. What's also good is to keep a neat operative field, and by doing so, you can keep all of these wires and sutures clean and out of the way and also color code the sutures so that you have
ease and ability to close them later. Finally, it's important to replace the dilator back in the sheath prior to having it removed. This is important just so that if there are problems with your percutaneous closure, you can always very quickly replace your sheath back in.
Again, we tend to color code the sutures so we can know which ones go with which. You can also place yet a third percutaneous access closure device if need be by keeping the guide wire in place. One other little trick that I actually learned
from Ben Starnes when visiting his facility is to utilize a Rumel mediated technique by placing a short piece of IV tubing cut length, running the suture through that, and using it like a Rumel, and that frees up your hand as you're closing up
the other side and final with closure. The contraindications to pREVAR. And I just want to conclude that there's increased use of fully percutaneous access for endovascular repair. There's trending advantages over conventional surgical exposure with decreased
access related complications, and improved outcomes can be attributed to increased user experience and comfort with percutaneous access, and this appears to be a viable first option. Thank you very much.
- So I'm just going to talk a little bit about what's new in our practice with regard to first rib resection. In particular, we've instituted the use of a 30 degree laparoscopic camera at times to better visualize the structures. I will give you a little bit of a update
about our results and then I'll address very briefly some controversies. Dr. Gelbart and Chan from Hong Kong and UCLA have proposed and popularized the use of a 30 degree laparoscopic camera for a better visualization of the structures
and I'll show you some of those pictures. From 2007 on, we've done 125 of these procedures. We always do venography first including intervascular intervention to open up the vein, and then a transaxillary first rib resection, and only do post-operative venography if the vein reclots.
So this is a 19 year old woman who's case I'm going to use to illustrate our approach. She developed acute onset left arm swelling, duplex and venogram demonstrated a collusion of the subclavian axillary veins. Percutaneous mechanical thrombectomy
and then balloon angioplasty were performed with persistent narrowing at the thoracic outlet. So a day later, she was taken to the operating room, a small incision made in the axilla, we air interiorly to avoid injury to the long thoracic nerve.
As soon as you dissect down to the chest wall, you can identify and protect the vein very easily. I start with electrocautery on the peripheral margin of the rib, and use that to start both digital and Matson elevator dissection of the periosteum pleura
off the first rib, and then get around the anterior scalene muscle under direct visualization with a right angle and you can see that the vein and the artery are identified and easily protected. Here's the 30 degree laparoscopic image
of getting around the anterior scalene muscle and performing the electrocautery and you can see the pulsatile vein up here anterior and superficial to the anterior scalene muscle. Here is a right angle around the first rib to make sure there are no structures
including the pleura still attached to it. I always divide, or try to divide, the posterior aspect of the rib first because I feel like then I can manipulate the ribs superiorly and inferiorly, and get the rib shears more anterior for the anterior cut
because that's most important for decompressing the vein. Again, here's the 30 degree laparoscopic view of the rib shears performing first the posterior cut, there and then the anterior cut here. The portion of rib is removed, and you can see both the artery and the vein
are identified and you can confirm that their decompressed. We insufflate with water or saline, and then perform valsalva to make sure that they're hasn't been any pneumothorax, and then after putting a drain in,
I actually also turn the patient supine before extirpating them to make sure that there isn't a pneumothorax on chest x-ray. You can see the Jackson-Pratt drain in the left axilla. One month later, duplex shows a patent vein. So we've had pretty good success with this approach.
23 patients have requires post operative reintervention, but no operative venous reconstruction or bypass has been performed, and 123 out of 125 axillosubclavian veins have been patent by duplex at last follow-up. A brief comment on controversies,
first of all, the surgical approach we continue to believe that a transaxillary approach is cosmetically preferable and just as effective as a paraclavicular or anterior approach, and we have started being more cautious
about postoperative anticoagulation. So we've had three patients in that series that had to go back to the operating room for washout of hematoma, one patient who actually needed a VATS to treat a hemathorax,
and so in recent times we've been more cautious. In fact 39 patients have been discharged only with oral antiplatelet therapy without any plan for definitive therapeutic anticoagulation and those patients have all done very well. Obviously that's contraindicated in some cases
of a preoperative PE, or hematology insistence, or documented hypercoagulability and we've also kind of included that, the incidence of postop thrombosis of the vein requiring reintervention, but a lot of patients we think can be discharged
on just antiplatelets. So again, our approach to this is a transaxillary first rib resection after a venogram and a vascular intervention. We think this cosmetically advantageous. Surgical venous reconstruction has not been required
in any case, and we've incorporated the use of a 30 degree laparoscopic camera for better intraoperative visualization, thanks.
- Talk to you a little bit about again a major paradigm shift in AVMs which is the retrograde vein approach. I mean I think the biggest benefit and the biggest change that we've seen has been in the Yakes classification the acknowledgment
and understanding that the safety, efficacy and cure rate for AVMs is essentially 100% in certain types of lesions where the transvenous approach is not only safer, but easier and far more effective. So, it's the Yakes classification
and we're talking about a variety of lesions including Yakes one, coils and plugs. Two A the classic nidus. Three B single outflow vein. And we're talking now about these type of lesions. Three A aneurysmal vein single outflow.
Three B multiple outflows and diffuse. This is what I personally refer to as venous predominant lesions. And it's these lesions which I think have yielded the most gratifying and most dramatic results. Close to 100% cure if done properly
and that's the Yakes classification and that's really what it's given us to a great degree. So, Yakes one has been talked about, not a problem put a plus in it it's just an artery to vein.
We all know how to do that. That's pulmonary AVM or other things. Yakes two B however, is a nidus is still present but there is a single outflow aneurysmal vein. And there are two endovascular approaches. Direct puncture, transarterial,
but transvenous retrograde or direct puncture of the vein aneurism with the coil, right. You got to get to the vein, and the way to get to the vein is either by directly puncturing which is increasingly used, but occasionally transvenous. So, here's an example I showed a similar one before,
as I said I think some of these are post phlebitic but they represent the archetype of this type of lesion a two B where coil embolization results in cure, durable usually one step sometimes a little more. In the old days we used to do multiple
arterial injections, we now know that that's not necessary. This is this case I showed earlier. I think the thing I want to show here is the nature of the arteriovenous connection. Notice the nidus there just on this side of the
vein wall with a single venous outflow, and this can of course be cured by puncture, there's the needle coming in. And interestingly these needles can be placed in any way. Wayne and I have talked about this.
I've gone through the bladder under ultrasound guidance, I've gone from behind and whatever access you can get that's safe, as long as you can get a needle into it an 18 gauge needle, blow coils in you get a little tired, and you're there a long time putting in
coils and guide wires and so on. But the cures are miraculous, nothing short of miraculous. And many of these patients are patients who have been treated inappropriately in the past and have had very poor outcomes,
and they can be cured. And that a three year follow-up. The transcatheter retrograde vein is occasionally available. Here's an example of an acquired but still an AVM an acquired AVM
of the uterus where you see the venous filling on the left, lots of arteries. This cannot be treated with the arterial approach folks. So, this one happened to be available
and I was having fun with it as well, which is through the contralateral vein in and I was able to catheterize that coil embolization, cured so. Three A is a slightly different variant but it's important it is different.
Multiple in-flow arteries into an aneurysmal vein wall. And the important identification Wayne has given us is that the vein wall itself is the nidus and there's a single out-flow vein. So, once again, attacking the vein wall by destroying the vein, packing
and thrombosing that nidus. I think it's a combination of compression and thrombosis can often be curative. A few examples of that this was shown earlier, this is from Dr. Yake's experience but it's a beautiful example
and we try to give you the best examples of a singular type of lesion so you understand the anatomy. That's the sequential and now you see single out-flow vein. How do you treat this?
Coil embolization, direct puncture and ultimately a cure. And that's the arteriogram. Cured. And I think it's a several year follow-up two or three year follow-up on this one.
So a simple lesion, but illustrative of what we're trying to do here. A foot AVM with a single out-flow vein, this is cured by a combination of direct puncture right at the vein. And you know I would say that the beauty of
venous approach is actually something which it isn't widely acknowledged, which is the safety element. Let's say you're wrong, let's say you're treating an AVM and you think okay I'm going to attack
from the vein side, well, if you're not successful from the vein side, you've lost nothing. The risk in all of these folks is, if you're in the artery and you don't understand that the artery is feeding significant tissue,
these are where all the catastrophic, disastrous complications you've heard so much about have occurred. It's because the individuals do not understand that they're in a nutrient artery. So, when in doubt direct puncture
and stay on the venous side. You can't hurt yourself with ethanol and that's why ethanol is as safe as it is when it's used properly. So, three B finally is multiple in-flow arteries/arterioles shunting into an aneurysmal vein
this is multiple out-flow veins. So direct puncture, coils into multiple veins multiple sessions. So, here's an example of that. This is with alcohol this is a gentleman I saw with a bad ulcer,
and this looks impossible correct? But look at the left hand arteriogram, you can see the filling of veins. Look at the right hand in a slight oblique. The answer here is to puncture that vein. Where do we have our coil.
The answer is to puncture here, and this is thin tissue, but we're injecting there. See we're right at the vein, right here and this is a combination arteriogram. Artery first, injection into the vein.
Now we're at the (mumbles), alcohol is repeatedly placed into this, and you can see that we're actually filling the nidus here. See here. There's sclerosis beginning destruction of the vein
with allowing the alcohol to go into the nidus and we see progressive healing and ultimately resolution of the ulcer. So, a very complex lesion which seemingly looks impossible is cured by alcohol in an out-flow vein.
So the Yakes classification of AVMs is the only one in which architecture inform treatment and produces consistent cures. And venous predominant lesions, as I've shown you here, are now curable in a high percentage of cases
when the underlying anatomy is understood and the proper techniques are chosen. Thanks very much.
- Like to thank Dr. Veith and the committee for asking me to speak. I have no conflicts related to this presentation. Labial and vulvar varicosities occur in up to 10% of pregnant women, with the worst symptoms being manifested in the second half of the pregnancy.
Symptoms include genital pressure and fullness, pruritus, and a sensation of prolapse. These generally worsen with standing. Management is usually conservative. Between compression hose, cooling packs, and exercise, most women can make it through to the end of the pregnancy.
When should we do more than just reassure these women? An ultrasound should be performed when there's an early presentation, meaning in the first trimester, as this can be an unmasking of a venous malformation. If there are unilateral varicosities,
an ultrasound should be performed to make sure that these aren't due to iliac vein thrombosis. If there's superficial thrombosis or phlebitis, you may need to rule out deep venous extension with an ultrasound. When should we intervene?
You may need to intervene to release trapped blood in phlebitis, or to give low molecular weight heparin for comfort. When should a local phlebectomy or sclerotherapy be performed? Should sclerotherapy be performed during pregnancy?
We know very little. Occasionally, this is performed in a patient who is unknowingly pregnant, and there have been no clear complications from this in the literature. The effectiveness of sclero may also
be diminished in pregnancy, due to hormones and increased venous volume. Both polidocanol and sodium tetradecyl sulfate say that there is no support for use during pregnancies, and they advise against it. So what should you do?
This following case is a 24 year old G2P1, who was referred to me at 24 weeks for disabling vaginal and pelvic discomfort. She couldn't go to work, she couldn't take care of her toddler, she had some left leg complaints, but it was mostly genital discomfort and fullness,
and her OB said that he was going to do a pre-term C-section because he was worried about the risk of hemorrhage with the delivery. So this is her laying supine pre-op, and this is her left leg with varicosities visible in the anterior and posterior aspects.
Her ultrasound showed open iliac veins and large refluxing varicosities in the left vulvar area. She had no venous malformation or clot, and she had reflux in the saphenofemoral junction and down the GSV. I performed a phlebectomy on her,
and started with an ultrasound mapping of her superficial veins and perforators in the labial region. I made small incision with dissection and tie ligation of all the varicosities and perforators, and this was done under local anesthesia
with minimal sedation in the operating room. This resulted in vastly improved comfort, and her anxiety, and her OB's anxiety were both decreased, and she went on to a successful delivery. So this diagram shows the usual location of the labial perforators.
Here she is pre-op, and then here she is a week post-op. Well, what about postpartum varicosities? These can be associated with pelvic congestion, and the complaints can often be split into local, meaning surface complaints, versus pelvic complaints.
And this leads into a debate between a top down treatment approach, where you go in and do a venogram and internal coiling, versus a bottom up approach, where you start with local therapy, such as phlebectomy or sclero.
Pelvic symptoms include aching and pressure in the pelvis. These are usually worse with menstruation, and dyspareunia is most pronounced after intercourse, approximately an hour to several hours later. Surface complaints include vulvar itching, tenderness, recurrent thrombophlebitis, or bleeding.
Dyspareunia is present during or at initiation of sexual intercourse. I refer to this as the Gibson Algorithm, as Kathy Gibson and I have talked about this problem a lot, and this is how we both feel that these problems should be addressed.
If you have an asymptomatic or minimally symptomatic patient who's referred for varicosities that are seen incidentally, such as during a laparoscopy, those I don't treat. If you have a symptomatic patient who has pelvic symptoms, then these people get a venogram with coils and sclerotherapy as appropriate.
If they are not pregnant, and have no pelvic symptoms, these patients get sclero. If they are pregnant, and have no pelvic symptoms, they get a phlebectomy. In conclusion, vulvar varicosities are a common problem, and usually conservative management is adequate.
With extreme symptoms, phlebectomy has been successful. Pregnancy-related varicosities typically resolve post-delivery, and these can then be treated with local sclerotherapy if they persist. Central imaging and treatment is successful for primarily pelvic complaints or persistent symptoms.
- Ladies and gentlemen, I would like to thank Professor Veith for his kind invitation. A minimally invasive carotid endarterectomy. I have nothing to disclose. Here you can see the same patient operating with the classic carotid endarterectomy with normal incision and on the other side,
you will see the patient, the same patient after the minimal incision carotid endarterectomy. So ladies and gentlemen, if one can safely perform carotid endarterectomy by minimal incision, let's do it routinely. The technique of minimal incision carotid endarterectomy.
The incision must be done over a carotid bifurcation. In slim patient, it is easy to determine the location just by the palpation. By routinely, I advise to mark bifurcation by using ultrasound. Reaching the artery by tissue separation
along the border of sternocleidomastoid muscle. Once the artery is visualized, apply the vessel loop on the external carotid artery. If it is needed, on the thyroid artery. Pulling the external carotid artery vessel loop up to the opposite side,
and releasing posterior part of bifurcation enables visualization and applying vessel loop on the common carotid artery, about 15 millimeter down the bifurcation. Pulling the external carotid artery vessel loop down into the opposite side reveals anterior and posterior
portion of internal carotid artery. What is the most important? The vessel loop on the internal carotid artery must be located above atherosclerotic plague. Temporary clamping of internal carotid artery for 30 seconds should show if the shunt is needed.
If there is no neurological signs, we continue pulling all vessel loops to elevate the artery to the level of the skin. Typically, longitudinal incision from common carotid artery to internal carotid artery is performed. The main important maneuver
that led to perform this operation correctly and safely, this is eversion-like movement. After arteriotomy, I squeeze the artery, internal carotid artery, usually on the level of the end of the atherosclerotic plague, usually using the forceps.
I make eversion-like movement. This led me easily and safely remove that atherosclerotic plague from the internal carotid artery. Always allow one two second backflow from internal carotid artery
to remove potential debris by the blood flow. The same, unclamping common carotid artery for a short period of time to remove potential debris from the proximal part. Should a shunt be indicated, it is easy and quick to insert.
As a first step, the shunt is inserted into internal carotid artery. It is necessary to slightly loosen internal carotid vessel loop. In the same way, I put the shunt into the common carotid artery if it is needed.
Continued suture usually close the arteriotomy. If the diameter of the internal carotid artery is smaller than two millimeter, artificial patch can be easily used. Redon drainage is always used. I make another small incision for the Redon drain
due to very, very small incision for endarterectomy. And continued suture usually closes the wound for good cosmetical effort. Here, you can see the operation step-by-step. What I will now emphasize this group of patient.
This is symptomatic patient with a very soft atherosclerotic plague. In this series, our experience. This is 165 patients allocated into two groups. 122 patients in the minimal incision carotid endarterectomy group,
and 43 patients in classic endarterectomy group. Patients randomly allocated. Here, you can see the results three months, up to three months results. I will like to emphasize there were no nerve injury. Hoarseness and shunt was used in 12%
in minimal incision carotid endarterectomy group. Here, you can see in the first and second column, the results up to September 2017. Third and fourth column, the results up to September 2018. Here you can see some examples. Here you will see some more examples.
Here you will see the scar that is after the operation. So nearly no limitation in neck movement, quick wound healing, short hospital stay, and perfect cosmetic effect. So to conclude, ladies and gentlemen, this is the low risk operation.
This is the operation of quick recovery. Precautions and contraindication, according to my experience seems to be same as for classic carotid endarterectomy. Of course, further study is required. Minimal incision, I also used during the
aortobifemoral and femoropopliteal operations. I hope to show it next year. Ladies and gentlemen, when I was a young surgeon, it was said that big surgeon, big incision. I'd rather suggest, good surgeon should try to make the smallest incision possible.
Data and presented technique will be published. Thank you very much for your attention.
- 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.
- 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.
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