- Lymphatic, so it's fun, actually, not to talk on venous interventions for once. And, naturally, the two systems are very different. But, on the other hand, they're also related in several ways and I will come back to that later. I have no disclosures, maybe only my gratitude to this man, Dr. Maxim Itkin,
who actually got me started in the field, and was gracious enough to supply me some of his material. And who is also responsible for making our lives way easier over the last years. Because in former times, we needed to do, to visualize the lymphatic system,
we needed to do pedal lymphangiography and that was very, very cumbersome. It took a long time and was very painful for the patient. And he introduced the ultrasound guided intranodal lymphangiography,
and that's fairly easy for most of us. With ultrasound you find a lymph node in the groin, you puncture that and you can control the needle position with contrast enhanced ultrasound and once you establish that position, you might do a MR lymphangiography.
Thereby showing, in this case, a beautiful, normal anatomy of the thoracic duct. I need to say, the variations in lymphatics are extreme. So, you can also visualize, naturally, the pathology, like for example, pulmonary lymphatic perfusion syndrome.
What's going on there. Normally, lymph courses up through thoracic duct, but in this case, you kind of have a reflux in the bronchial tree and lymph leakage. And you can image that again, beautifully with MR, which you can show extensive leakage
of lymph in the lung parenchyma. So you can treat that. How can you treat that? By embolization of the thoracic duct. But first we need to get into there, and that's not a very easy thing to do.
But now, again, with access to a lymph node in the groin, you can push lipiodol, and then visualize the cisterna chyli and access that transcutaneously with a 21/22 gauge needle and then push up a O-18 wire high up in the thoracic duct.
First you deploy some coils to prevent any leakage of glue inside the venous system, and then by microcatheter, you infuse glue all the way down, embolizing the thoracic duct. So, complete different group of lymphatic disorders is oriented in the liver and hepatic lymphatic disorders.
And maybe not everybody knows that, but 80% of the flow in the thoracic duct is caused by the liver and by the intestine. And many times in lymphatic disorders, there needs to be a combination of two factors. One factor is a venous variation of a,
sorry, an anatomical variation in lymph vessels and the other one is that we have an increase in lymph flow. And in the liver, that can be caused by a congestion of the liver, for example, cirrhosis, or a right side, that's congested heart failure.
What happens then is you increase the flow, the lymph flow, tremendously and if you also have a variation like in this case, when the vessels do not directly course towards the cisterna chyli, but in very close contact to the abdomen,
then you can have leakage of the lymph and leakage of proteins, which is a serious problem. So, what is then, to do next? You can access the lymph vessels in the liver by percutaneous access in the periportal space,
and induce some contrast and then later, visualize that one back, visualize that with dye that you can see with an endoscopy, thereby proving your diagnosis, and then, in a similar way,
you can induce lipiodol again with glue, embolizing the lymph vessels in the liver, treating the problem. In summary, popularity of lymphatic interventions really increased over the last years mainly because novel imaging,
novel interventional techniques, new approaches, and we all gained more experience. If you would like, I would guess that, we are at a phase where we were at venous, like 10, 15 years ago. If we are a little bit positive,
then the future is very bright. And within 10, 15 years, we find new indications and probably have much more to tell you. Thank you for your attention.
- 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.
- Good morning. I'd like to thank Dr. Veith and Symposium for my opportunity to speak. I have no disclosures. So the in Endovascular Surgery, there is decrease open surgical bypass. But, bypass is still required for many patients with PAD.
Autologous vein is preferred for increase patency lower infection rate. And, Traditional Open Vein Harvest does require lengthy incisions. In 1996 cardiac surgery reported Endoscopic Vein Harvest. So the early prospective randomized trial
in the cardiac literature, did report wound complications from Open Vein Harvest to be as high as 19-20%, and decreased down to 4% with Endoscopic Vein Harvest. Lopes et al, initially, reported increase risk of 12-18 month graft failure and increased three year mortality.
But, there were many small studies that show no effect on patency and decreased wound complications. So, in 2005, Endoscopic Vein Harvest was recommended as standard of care in cardiac surgical patients. So what about our field? The advantages of Open Vein Harvest,
we all know how to do it. There's no learning curve. It's performed under direct visualization. Side branches are ligated with suture and divided sharply. Long term patency of the bypass is established. Disadvantages of the Open Vein Harvest,
large wound or many skip wounds has an increased morbidity. PAD patients have an increased risk for wound complications compared to the cardiac patients as high as 22-44%. The poor healing can be due to ischemia, diabetes, renal failure, and other comorbid conditions.
These can include hematoma, dehiscense, infection, and increased length of stay. So the advantages of Endoscopic Vein Harvest, is that there's no long incisions, they can be performed via one or two small incisions. Limiting the size of an incision
decreases wound complications. It's the standard of care in cardiac surgery, and there's an overall lower morbidity. The disadvantages of is that there's a learning curve. Electro-cautery is used to divide the branches, you need longer vein compared to cardiac surgery.
There's concern about inferior primary patency, and there are variable wound complications reported. So recent PAD data, there, in 2014, a review of the Society of Vascular Surgery registry, of 5000 patients, showed that continuous Open Vein Harvest
was performed 49% of the time and a Endo Vein Harvest about 13% of the time. The primary patency was 70%, for Continuous versus just under 59% for Endoscopic, and that was significant. Endoscopic Vein Harvest was found to be an independent risk factor for a lower one year
primary patency, in the study. And, the length of stay due to wounds was not significantly different. So, systematic review of Endoscopic Vein Harvest data in the lower extremity bypass from '96 to 2013 did show that this technique may reduce
primary patency with no change in wound complications. Reasons for decreased primary patency, inexperienced operator, increased electrocautery injury to the vein. Increase in vein manipulation, you can't do the no touch technique,
like you could do with an Open Harvest. You need a longer conduit. So, I do believe there's a roll for this, in the vascular surgeon's armamentarium. I would recommend, how I use it in my practices is, I'm fairly inexperienced with Endoscopic Vein Harvest,
so I do work with the cardiac PA's. With increased percutaneous procedures, my practice has seen decreased Saphenous Vein Bypasses, so, I've less volume to master the technique. If the PA is not available, or the conduit is small, I recommend an Open Vein Harvest.
The PA can decrease the labor required during these cases. So, it's sometimes nice to have help with these long cases. Close surveillance follow up with Non-Invasive Arterial Imaging is mandatory every three months for the first year at least. Thank you.
- Thank you very much Tony, It's an honor to be part of this distinguished faculty. This is a landmark paper that truly revolutionized the management of Iliac vein disease, and you can see in this great experience of Doctor Raju and Neglen,
that primary disease, May-Thurner syndrome, can be treated with a secondary patency of 100% at five years and even in post traumatic patients, the secondary patency rate in this series was 86%. Now it was not immediately recognized that Contralateral Deep Vein Thrombosis is a problem.
In this paper, the authors mentioned that Contralateral Iliac Vein Thrombosis was generally benign and infrequent, 1%. The same group however with increasing experience recognized that some patients, who undergo Iliac Vein stenting have a problem if the stent is extended into the iliac vein.
And they did a comparative series where one group included wallstents that were extended into the inferior vena cava because of the underlying anatomy to correctly treat the disease. And the control group had Z-Stent on top of the wallstent which as you could see in the previous presentation
has much larger gaps between the metal struts. Wallstent in critical areas like under the compression of the right common iliac artery or even the groin can be compressed because of the construction of the stent. And you can see that there was a significant difference from Ipsilateral Deep Vein Thrombosis
if you used a stronger Z-Stent than if you used just a wall stent. But obviously the important finding is that there was a significantly higher rate of Contralateral Deep Vein Thrombosis if you extended the wall stent without protection
of the Z-Stent. Now there are additional papers that have come out since this publication. This is a combined European experience that, oh no actually, this is just the conclusion of the study that obviously
the Z-Stent modifications provides protection. But this is the European experience that only show that 4% had identified multiple factors in addition to extension like Acute disease, previous Contralateral Deep Vein Thrombosis or non-compliance with anticoagulation.
This paper however didn't really differentiate between extension and coverage, complete coverage of the Contralateral outflow. This is another paper from Dr. Gillespie group that again, thought that those patients who were non-compliant with anticoagulation,
those had an increased risk of Contralateral Deep Vein Thrombosis. Now this is a very important paper. It's 111 patients that was just recently published in the Jvir What is interesting in this patient
that Contralateral Deep Vein Thrombosis developed in 10 patients at a median time of 40 month after the operation. And I think that's very important. That this is not an early complication. This is a late complication.
And it's obvious from their findings, that you may not find a significant difference as long as you partially cover the iliac vein. But if you completely cover the iliac vein, 32% of these patients had Contralateral Deep Vein Thrombosis with a significant difference.
We found that in our experience too that when we explanted a stent that the outflow was practically already halfway thrombosed and you can see the pseudointima that really depends on the poor size of the stent. And that's why actually any stent
that has this small size has a problem. And so we called to abandon on extending the wallstent into the inferior vena cava. I think the take home message now that you should remember is that overextension of the iliac vein stent into the IVC and completely covering the inflow
from the Contralateral Iliac Vein is obviously a clear and present danger of delayed, not early, delayed Contralateral Deep Vein Thrombosis. Thank you.
- So, in terms of my presentations, I think Dr. Mills and I do have some agreement that we can treat some of these patients with intervention, initially at least, with some exceptions. So when we talk about treating patients with acute limb ischemia, advanced endovascular skills is a must.
You have to look at the appropriateness of the devices that we have in place. But also, I think the most important thing is that you have to achieve adequate arterial inflow to the foot by the time you've finished the procedure
with the improvement of pain, numbness, and any motor abnormality. Certain cases, obviously, you need open surgery such as emboli from atrial fibrillation to the femoral artery. But it is important to note that in terms
of acute limb ischemia, when you go from IIa to IIb, that's when you have to be aggressively try to open up as much as possible, again, with adequate flow to the foot. And again, with acute limb ischemia, its definition is less than 14 days.
It could be embolic versus thrombotic. And my focus is mostly on these targets on the thrombotic component because it has a high risk of limb loss. And again, the traditional open bypass surgery has been associated with increased risk
of morbidity and mortality as well as wound infection. When we talk about acute limb ischemia, you can, again, do surgery with thrombectomy, embolectomy, and again, open procedure, or you can do open surgery with intraoperative thrombolytics.
And again, what I go for is try to do, obviously, a diagnostic angiography followed by endovascular interventions using various technology that is in hands. And again, multiple publications has been shown that we can perform this procedure successfully
in patients with acute limb ischemia. And again, at least in the studies that I was involved with, we can see that 60% of these procedures can be completed in less than six hours and 80% was completed in 24 hours, maximizing the flow to the foot and limb salvage.
So this, again, in the PEARL registry, was shown to be both in acute and chronic cases. And again, significant improvement in terms of the treated vessels. So the goal of the treatment is removal of the clot, re-establish perfusion, minimize clot reformation,
but more importantly, identify the underlying lesion and the culprit and treat it. So again, treatment of the acute limb ischemia in percutaneous method by using thrombolysis and thrombectomy provides a minimally invasive alternative to restore perfusion to the symptomatic lower extremity
with minimal morbidity and mortality. And you can do it both for native vessels as well as in a bypass graft. In native vessels, you have a combination of a fresh thrombus superimposed on chronic atherosclerotic disease.
And by removing the thrombus, you can visualize the underlying occult lesion that's causing the occlusion. And again, by doing it endovascularly, you can identify the inflow, the occluded segment, and the outflow in a percutaneous fashion and open up the blood vessels.
And again, in my experience, you have also avoided fasciotomy and reperfusion injury because it's in a non-open technique. What are the benefits? Again, your benefits is that you convert the patients from an acute state
to a baseline chronic state. This is especially if you're doing something at two o'clock in the morning. Convert an urgent surgical intervention to an elective revascularization if necessary. You lyse the thrombi in the distal artery,
restoring patency to the outflow arteries which you cannot do surgically, or we have multiple incisions. Re-establish the patency of an occluded but non-diseased inflow source for possible subsequent bypass,
especially if the patient was presented to you late and has thrombosed off into the common femoral artery. Prevent arterial intimal injury from balloon catheter thrombectomy, avoiding operative thromboembolectomy, especially if you involve the tibial vessels,
then you have to go through each of those tibials and do open embolectomy. And then again, also you reduce the level of amputation in patients in whom complete success cannot be achieved. So, then end up either with a toe amputation
or a TMA, or they end up with a BKA or an AKA previously. The tool box involves, again, antiplatelet therapy. IIb, III inhibitors are extremely important, anticoagulants to make sure that the patient's anticoagulated.
You have your choice of tPA or rPA, infusion catheters, and various catheter devices to aspirate or remove the clot. Again, tool boxes: contralateral insertion, six Fr sheath, guard wires through the area of occlusion.
Again, in the case of the fresh thrombus, if you remove the thrombus, you can see the underlying culprit lesions which you can treat by endovascular interventions. In the native vessels, again, you want to be able to use a hydrophilic wire that goes easily
to the area of occlusion. And then after removing the clot, you can see the underlying lesion that can be treated successfully, therefore avoiding a major bypass surgery. And to finish up with a case,
58-year-old female comes in with rest pain and numbness for about two weeks. Again, multiple medical problems. ABI is 0.2. You can see in this case, the angulation is difficult, so it came to an antegrade puncture.
You can see the occlusion of the infrapopliteal segment, only a perineal one off. The wire goes very easily. Once you remove the thrombus, you can see that now the artery is open. However, there is a chunk of thrombus sitting in there.
And again, she has a single pair runoff to the leg, so in this case, we don't want to compromise that single runoff even though we removed most of the clot. So we use a filter wire and use an angiojet to remove the clot. You can see the underlying lesion here.
Is it a plaque rupture or a stenosis? Angioplasty was done. She goes home in the next day instead of having a fem perineal bypass graft. So in summary, again, majority of these patients can be treated effectively
with percutaneous techniques. Advanced techniques and experience is appropriate because of essential tools in hand to make sure that this is an outcome completed successfully. Thank you for your attention.
- Thank you, Captain, and I'd like to thank Doctor Veith for the opportunity today to further this discussion about vascular injury care, specifically endovascular options that have continued to emerge and become a bigger part of our practice. Vascular trauma remains a challenging entity
for anyone who takes care of trauma patients, on the battlefield it accounts for 12% of our trauma incidents and it's the second leading cause of death in both civilian and military trauma. And some of the most challenging
are those non-compressible sites which represent a majority of those that we really struggle with. There are a number of involving technologies and approaches that have been applied to trauma, we were going to talk in other talks about
REBOA and some of those options. But for the purpose of the talk here, I'm really going to talk about endovascular stent grafts as emergent and definitive tool managements. These make sense for a variety of reasons,
endovascular is becoming a bigger part of the trauma toolkit because we've had a significant shift in elective and emergency vascular work towards endovascular surgery. Every trauma center now, if they don't have one, is developing a hybrid OR environment
which is capable of providing high-end endovascular care. And we have an increase in familiarity both among surgeons, IR providers, and a variety of providers who take care of these trauma patients. Unfortunately, however, we as of yet do not have
any trials yet to prove the practice is better than open approaches. But we do have some success stories. A blunt thoracic aortic injury, if you have to pick one, is certainly a success story in trauma. Everyone in this audience is familiar
with the way that this has evolved. This is just one of a number of studies including the two AAST Center studies in 2008 and 2009 by the Aortic Trauma Foundation recently published in 2015 which showed that TEVAR was associated with lower transfusion requirements,
lower overall mortality, and lower aortic-correlated mortality compared to traditional open-repair modalities. And in the time that these technologies have been introduced, they have really changed practice. But what about other locations?
We have a variety of other anatomic locations that historically and traditionally have been challenging surgical exposures, the carotid at the base of the skull, the thoracic inlet, all these represent challenging options for open repair amongst trauma surgeons.
We do have some good evidence that needs to be expanded and further built upon that carotid capabilities from an endovascular stent graph repair perspective, particularly for those injuries at the base of the skull can be performed with a reasonable modicum of success. And with good followup to two weeks to two years,
patency rates are about 80% with low appreciable neurologic deficits after stent placement. Axillo-subclavian injuries represent another challenging open exposure for most trauma surgeons and an opportunity for vascular surgeons to introduce some more effective endovascular
stent graft technologies for application. Just one paper here from a myriad of trauma centers, a collaboration conducted by Doctor Branco, who showed that endovascular repair with injuries at these locations was associated with significantly lower mortality,
lower rates of surgical site infections, and a trend toward lower sepsis rates. And when you look overall at the invasion, if you will, of endovascular technologies this was a very nice review from a national trauma data bank of the American College of Surgeons,
which was conducted over nine years and over 40,000 vascular injuries. And you can see there, over time, we have seen a significant increase in use of endovascular procedures to deal with these injuries. I would say now that that is based upon data
from the PROOVIT Registry that is now roughly 20% of all vascular injuries have some endovascular technology applied. And these resulted in lowering hospital mortality following endovascular intervention and lower complication rate trends.
This is the most recent review, conducted by one of our visiting fellows when I was at David Grant, Major Robert Faulconer was a review of the AAST, or American Association for the Surgery of Trauma, perspective observational vascular injury treatment trial,
or called PROOVIT for short. And just very briefly, the punchline from this examination was that favorable outcomes were observed when arterial injury at non-compressible sites of truncal hemorrhage was managed with endovascular approaches.
The endovascular group, despite being more severely injured, had a lower mortality and a lower packed red blood cell requirement. And we're also learning that these technologies can be applied in hybrid techniques. This is just a simple example of a case
that was encountered at my own institution, this was a young man who had a gun shot wound through the right iliac artery and vein. He had an attempted interposition repair which blew out in the setting of small bowel contamination from associated bowel injury.
And we were really left with a very challenging situation in a patient who was physiologically depleted and would not tolerate a repeat definitive repair. And very little tissue to roll over the graft. So what we selected to do was what is known as a direct stent endo graft repair, or DSER.
And we basically bridged this gap with an endovascular stent graft utilizing the radial force to create a space for repair and not having a suture line now at risk in this contaminated field. This patient did quite well and
is now six months out with good results. This has been written about by several individuals and investigators to explain the use of stent grafts not only as a proxy or replacement for the typical plastic argyle shunt options, but these can actually potentially
become left in place when you come back for the repeat damage control surgery after initial repair. You can cover this with tissue graft and you now have a sutureless repair that is not prone to blow out as many of these injuries are in contaminated fields. Lots of unresolved issues with the investigation
and continued research in vascular traumas, particularly as it relates to endovascular graft repairs. Patient selection, we deal with young patients, small vessels, that natural history's not well established, anticoagulation and the definitive role of endovascular at a variety of locations is not well defined.
I mentioned the PROOVIT Registry, this has been going on for a number of years. It captures in-hospital outcomes and outpatient module questions. We do hope that this was able to answer some of the significant questions that we have in this area.
As of this month, we have over 4,000 patients in 27 centers, we still invite others to participate if anyone in the audience is interested. And we have a variety of issues we have already examined and will continue to examine in hopes that we can answer many of the questions
related to the optimal treatment of vascular injury. Thank you.
- 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.
- 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, I've changed the title little bit, instead changes in AA neck morphology after standard EVAR and CHEVAS and they can be subtle and missed. And I'm a co-founder of endovascular diagnostics and my background of my slides is black because yesterday, Teo Fleugus passed away. Teo has served the endovascular fields
for more than two decades and Teo is an iconic and humorous Dutch giant and it's always been a pleasure and honor to work with him. The background of this presentation, slight changes in apposition and position of endograft in aortic neck can be missed
with standard imaging techniques like CT scans and duplex and the follow up imaging nowadays should prevent and should predict complications and not only show complications. That's why we, well we developed software, homemade software for precise determination
of the endograft position and apposition in the aortic neck post EVAR. And it serves, we transport the mesh of the aorta from a standard CT scan and use the 3D coordinates of a 3Mensio workstation and we definitely are able to calculate
and determine almost all the positional changes of the endograft in the neck post EVAR and also calculate the apposition of the endograft in the aortic neck. Well here, you can see some of the changes. The yellow bar is the apposition,
the circumferential apposition of the endograft in the aortic neck and during follow up, you can see that there is a loss of apposition, and of course, you want to avoid there is a complete loss in the patient coming with a type 1A endoleak and a rupture.
But to prove the concept of course, we had to prove that the software could really predict endografts' failure like migration and type 1A endoleak, so we had a co-ord of four groups of patients patients with type 1A endoleak,
patients with migration more than 1 centimeter, and those included 45 patients, then we had control patients without any endoleak or migration. We did a software analysis, so the determination of the apposition and position of the endograft in the aortic neck and we compared in the first
post-EVAR CTA scan and the late CTA scans, and here you can see what we mean with late CTA scan in the patients with type 1A endoleak and migration, it was the CT scan before the CT scan where the complication occurred.
Well, with the new software this is all on the CT scans before the complication in the patient with type 1A endoleak and migration, there is significantly loss of apposition, length, and also in the patient group with migration and the CTs
come before the complication really occurs the apposition is significantly lower. And also, there is more endograft expansion in the patients with migration, the endografts almost have expanded to 100%, and of course then
you will have a seal failure. What about EVAS? It is more challenging to calculate the apposition, so in the software we don't calculate the apposition but the non-apposition surface post
EVAS and post chimney EVAS. Here you can see one of the examples, the red area is the non-apposition, post-EVAS and also here you can see that sometimes it can be very subtle changes if you compare the one month and the
one year CT scan for these graft migrates because there is an increase in non-apposition. There are some different kind of migrations we call it displacement, post EVAS because it's not only a real migration but sometimes the endo backs and the stent frames bow,
and that causes also a kind of migration. And loss of apposition in inter-renal neck. And what is another important thing is you really have to determine the 3D position of the stent frames because here again we have the software usually in red
in the six months follow up, a slight displacement of the stent frames, and during one year, and 18 months here, you can see complete displaced stent frame, well of course again you want to have dealt complication before the complication
really occurs so you want to see it after 6 months. We have 20 patients with chimney EVAS. Five of them suffer a type 1A endoleak during follow up and again, we calculated the non apposition surface but also the other stent frames displacement and as you can see
here on this figure, there is a correlation between the displacement of the stent frames and the chimney grafts itself. Can we also predict (unclear), yes the five patients on the right is at a one-year CT scan, slight movement and displacement,
and here at more than one year, all those patients have type 1A endoleak and even one had a rupture. So to conclude, determination of the position and apposition of the stent grafts post-EVAR is, well it's necessary and we can
miss that with the standard CT scans so we advise to use them, the new software, which can really predict complications post-EVAR and EVAS, thank you very much.
- [Presenter] Thank you very much, Mr. Chairman, and ladies and gentlemen, and Frank Veith for this opportunity. Before I start my talk, actually, I can better sit down, because Hans and I worked together. We studied in the same city, we finished our medical study there, we also specialized in surgery
in the same city, we worked together at the same University Hospital, so what should I tell you? Anyway, the question is sac enlargement always benign has been answered. Can we always detect an endoleak, that is nice. No, because there are those hidden type II's,
but as Hans mentioned, there's also a I a and b, position dependent, possible. Hidden type III, fabric porosity, combination of the above. Detection, ladies and gentlemen, is limited by the tools we have, and CTA, even in the delayed phase
and Duplex-scan with contrast might not always be good enough to detect these lesions, these endoleaks. This looks like a nice paper, and what we tried to do is to use contrast-enhanced agents in combination with MRI. And here you see the pictures. And on the top you see the CTA, with contrast,
and also in the delayed phase. And below, you see this weak albumin contrast agent in an MRI and shows clearly where the leak is present. So without this tool, we were never able to detect an endoleak with the usual agents. So, at this moment, we don't know always whether contrast
in the Aneurysm Sac is only due to a type II. I think this is an important message that Hans pushed upon it. Detection is limited by the tools we have, but the choice and the success of the treatment is dependent on the kind of endoleak, let that be clear.
So this paper has been mentioned and is using not these advanced tools. It is only using very simple methods, so are they really detecting type II endoleaks, all of them. No, of course not, because it's not the golden standard. So, nevertheless, it has been published in the JVS,
it's totally worthless, from a scientific point of view. Skip it, don't read it. The clinical revelance of the type II endoleak. It's low pressure, Hans pointed it out. It works, also in ruptured aneurysms, but you have to be sure that the type II is the only cause
of Aneurysm Sac Expansion. So, is unlimited Sac Expansion harmless. I agree with Hans that it is not directly life threatening, but it ultimately can lead to dislodgement and widening of the neck and this will lead to an increasing risk for morbidity and even mortality.
So, the treatment of persistent type II in combination with Sac Expansion, and we will hear more about this during the rest of the session, is Selective Coil-Embolisation being preferred for a durable solution. I'm not so much a fan of filling the Sac, because as was shown by Stephan Haulan, we live below the dikes
and if we fill below the dikes behind the dikes, it's not the solution to prevent rupture, you have to put something in front of the dike, a Coil-Embolisation. So classic catheterisation of the SMA or Hypogastric, Trans Caval approach is now also popular,
and access from the distal stent-graft landing zone is our current favorite situation. Shows you quickly a movie where we go between the two stent-grafts in the iliacs, enter the Sac, and do the coiling. So, prevention of the type II during EVAR
might be a next step. Coil embolisation during EVAR has been shown, has been published. EVAS, is a lot of talks about this during this Veith meeting and the follow-up will tell us what is best. In conclusions, the approach to sac enlargement
without evident endoleak. I think unlimited Sac expansion is not harmless, even quality of life is involved. What should your patient do with an 11-centimeter bilp in his belly. Meticulous investigation of the cause of the Aneurysm Sac
Expansion is mandatory to achieve a, between quote, durable treatment, because follow-up is crucial to make that final conclusion. And unfortunately, after treatment, surveillance remains necessary in 2017, at least. And this is Hans Brinker, who put his finger in the dike,
to save our country from a type II endoleak, and I thank you for your attention.
- 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.
- First of all let me thank Dr. Veith for the kind invitation to be here again and it's my great pleasure to share with you the preliminary result of our Indian registry. So these are my disclosures. So as vascular surgeon we have to admit that the Fogarty embolectomy has many possibility
but also some limitation. You can see here in this short video that we were able to remove thrombus, but thrombus was mixed up with plaque, hyperplasia and the final result was a very poor backflow from this vessel.
So already a couple of years ago we published our experience comparing the Fogarty embolectomy with the hybrid treatment that at that time was Fogarty plus a lot of endovascular rescue maneuver and of course hybrid was better, but we were very surprised by this.
What we found that the introvert in geography after Fogarty we had a number of chronic disease this is normal, but we also found a number of residual thrombus because firmly adherent to the arterial wall or just not appropriately reached by the Fogarty balloon embolectomy.
Even the over the Y Fogarty balloon embolectomy cannot work enough well. And then finally we also had a number of case with the injuries. Probably from inappropriate Fogarty balloon maneuver into the vessels so we had to find something more.
We had to find something less traumatic and so we realized that at the same time our colleagues from stroke unit, the neurologist had already a very nice tool in their hands. It's the Penumbra system which has began the market leader in stroke because it's very atraumatic,
dedicated for intracranial vessel navigation and then has a very high aspiration power system. So a couple of years later the company came on the market with the family dedicated to peripheral artery, the Indigo System from three to eight French catheter
designed for peripheral artery. So really improved trackability and atraumatic tip of this catheter. So how does the system work? You have already seen this video, but anyway you have first to engage the clot then you switch on
the aspiration power and then from proximal to distal you can remove all the thrombus, you can use the separator guide wire that breaks up the clot when ingested into the catheter and so the final result is that the tip of catheter is all we part and that you can remove all the thrombus
in very few minutes. Now I want to show to you my very first case it was four years ago and the system was not yet available and I for prefer I had some conflicting result with the other with competitors. I have incomplete reperfusion or hemolysis.
I have very positive feedback from my colleagues from the stroke unit at my University. I had the possibility to borrow the neuro catheters. So in this very first patients, unfit for lysis with a lot of thrombus, fresh thrombus in a vein popliteal area and the tibial artery I used
neural catheters, separate was very easy even at the beginning of our experience and we were able to engage the clot use the separator and removing in a couple of passage old thrombus even from the very distal localizations. So up to now we have used the Indigo family,
Indigo system in a lot of situation I can go through all this the one, but I want to show you how far we can go and it's a very challenging situation within dialysis dependent patients with the calcify kink and tibial artery and thrombus in the plantar arch
we were able to reach the plantar arch with the CAT 3 device and remove all the thrombus. Since then we have decided to collect data in a prospective national registry, the Indian registry. We want to collect 150 case in this prospective registry. We started last year and we actually included any kind
of acute lower limb ischemia embolism, thrombosis, graft endograft thrombosis, distal emboli and secondary to preceding intervention or even incomplete reperfusion after Fogarty and lysis. We evaluated the vessel patency by TIMI score of course we have now 136 patients enrolled by 17 centers active
and Ethiological hypothesis of the ischemia was in the 3/4 of case thrombotic, so the most challenging case. Acute and chronic ischemia mainly in very popliteal area or even below the knee or below the ankle in arteries. And here are preliminary result available for 120 patients.
After the Indigo use we already have a 90% TIMI two or three flow restoration will raise up to 96% after additional PTA or stent or additional lysis. So in conclusion these are only the preliminary result I hope to share with you our final result next year,
but at that moment we can already say that the Indigo is safe and effective option for acute lower limb ischemia, technical success is high even in small arteries, and up to now adverse event related to the device is very low and bleeding and hemolysis are not reported.
- Thank you Frank, it's an honor to be here. This lengthy title, what this is actually about is to make it little shorter is, off-label use of EVAR, typically in challenging neck anatomy, and the question is whether it's safe and if so, under what conditions. And I just want to underline, this is no way
some kind of U.S. legal statement, it's just a physician's perspective on this problem. Here's the title in short and I'll walk you through it. When it comes to the off-label thing, what it's all about is that it's outside of IFU and the IFU, what that means is that something is consistent with the premarket approval.
Outside of IFU, that means that something is not entirely proven. This does not mean that it is forbidden. It does not mean that it is necessarily bad, but it is likely that you will encounter worse outcome. And the question then is, whether this is justifiable.
And this in turn will depend heavily on what the alternatives are, of course. This debate is mostly about challenging necks, when it comes to EVAR, and this is the kind of scenario when the most senior, not to say the oldest colleagues step forward and tell you that
don't do EVAR, this is outside of IFU. Are they right then? Well, it depends on what alternative they can offer. Is the open surgical repair justifiable in this type of scenario? And I have this bad habit of bringing fresh cases and
this is from October, 2018, a ruptured case, 70-year old male patient. Obviously the neck is challenging. Anything you do will be outside of IFU. You could probably do some homemade fenestration or chimney or whatever, but it will be outside of IFU.
And the advice then was to preserve the renal function for sure, do the open surgical repair. The patient was operated on open, not by me, by a very experienced colleague. The operation was extremely smooth. The patient did very well, but he had a minor GI bleed
two weeks post-op and therefore this CT was done, and as you can see, the kidney is not doing very well because those very close to the renal artery stitches had somehow engaged that renal artery, and I do believe that any of those homemade chimneys or fenestrations would have done an equally good job.
So I think that when it comes to the suprarenal clamping, the aorta, above the SMA, above the renal artery, I think that's such a clamp. If this was actually a new device, comparable to a new stent graft, I doubt that it will be inside any IFU actually.
And if you look at the results, the suprarenal clamp is typically used in elderly patients, it's associated with more renal problems, and the mortality is significantly higher. Also, we have to remember that, oh my slides don't show, I'm sorry for that.
They worked when I tested them in the room. What it shows is that it is the unfit patients that have the largest aneurysms, the largest necks, and the most tortuous aortas. So, the worst patients who need the suprarenal clamping are the sickest patients, and I do agree that the
fenestrated branch, chimneys, sandwiches, whatever you use, are outside the IFU, but in my world, the suprarenal clamping in this scenario, probably is also outside of the IFU, if that was the kind of case. So, is it safe?
Well, what you have to compare is the stenting of the branches versus the suprarenal clamp. And the trauma you have to compare is the percutaneous approach versus a major open surgery. I believe that today there is no evidence that open surgical repair is safer in that scenario and
until it has been proven, EVAR is to be preferred. Under what condition? Well, I think that as long as there is an endo solution at all, it should be used because these patients are poor candidates for EVAR and therefore they are high risk candidates for open surgical repair also.
So in conclusion, Mister chairman and ladies and gentlemen, I believe that the off-label-use of EVAR, is it safe? No, of course it's not! But it is justified because in these patients, the alternative, the open surgical repair, is not safe either and it is a much greater trauma to the
patients, thank you for your attention.
- Thank you and good afternoon. I have no financial disclosures. The prevalence of buttock claudication in the general population is really unknown. But up to a third of patients do develop the problem after aortic reconstruction. Both open and endovascular.
And differentiating these symptoms from other common etiologies of hip and buttock discomfort, can literally be a pain in the butt sometimes. Standard non-invasive evaluation only looks at axial lower extremity arterial inflow and not the parallel or collateral pelvic flow.
So that's not a good way to evaluate these symptoms. There is evidence that shows that skin probes assessing oxygen saturation placed over the buttock accurately reflect the oxygen saturation of the gluteal muscles and that is what forms the basis of the buttock O2 study protocol,
where two probes are placed on both buttocks and both calves with a baseline probe on the chest. The patient stands for 10 minutes, with a two minute baseline value that is recorded. And then walks on the treadmill, preferably for up to 12 minutes.
Or until forced to stop. And then a 10 minute recovery phase is recorded to watch the values come back to normal. That raw data is transferred directly onto a propriety software program and then analyzed. Normalized against the chest lead changes
and then a drop of greater than 15 millimeters of mercury is chosen as indicating significant internal iliac artery inflow compromise. So patients being referred to our lab had the study in an effort to differentiate vasculogenic from neurogenic claudication.
And also to evaluate the relative severity of buttock versus calf claudication, to promote the appropriate treatment. We looked at patients who had had concomitant imaging within six months of the study, and had an independent blinded observer grade
the degree of internal iliac artery inflow compromise, into moderate and severe. Also giving consideration to tandem lesions. There were 137 patients who had the study thus far in our lab. And 26 of these had no imaging within
that six month period, so were excluded. Majority of the patients had symptoms in various parts of their bodies. So there were 111 patients total, after excluding the ones with no imaging. 56 patients had positive studies.
24 couldn't complete the protocol, so were technically not vasculogenic claudication. The drop of greater than 15 millimeters of mercury was now statically correlated to internal iliac artery flow reduction on imaging. And you can see the C-statistic values for both moderate
and severe inflow compromise was reasonable. But most specifically, the specificity to predict moderate and severe stenosis was quite good. What about treatment of buttock claudication? So, after you've got them to stop smoking, the options for revascularization include,
aorta iliac bypass, or endarterectomy, with bypasses into the internal iliac artery, in an end to end, or an end to side manner. Of course over the last several years endovascular treatment has taken the front role. Including various forms of stenting.
Also within the interstices of prior common iliac and external iliac stents. So looking at our experience in this regard, we have results on 95 patients. Majority of them did actually complain of symptoms of buttock claudication.
But we don't have the (mumbles) to study available for most of them because these are historical patients. About a third had bypass treatment. Third endarterectomy and a third endovascular options. And you can see over the last decade or so,
it's a lot of endovascular option. Looking at the follow up, the median follow up is 7.1 years. Longer in the open group than the endovascular group. And the vast majority of patients did have relief of symptoms. Five year patency was of the order of 72% overall
and was not effected by the type or extent of revascularization. And interestingly, also by the degree of stenosis in the internal iliac artery. We do have pre and post studies in the more recent patients.
And this is a 71 year old gentleman with left buttock and right calf claudication. Had successful right iliac stenting, but not popliteal intervention. And you can see the blue tracing of the buttock has normalized.
But that of the calf, which is red, has not. Another patient with bilateral buttock and thigh claudication had bilateral common iliac artery stent placement to improve inflow, without treatment of the internal iliac lesion. And you can see that the right buttock remains below
the baseline, while other parameters have now normalized on the post procedure study. So to conclude, non-invasive evaluation of suspected buttock claudication with exercise TcPO2 is reliable with ability to reserve imaging
for patients with positive studies. And also, good ability to differentiate from other non-vascular causes of buttock and hip discomfort. Open and endovascular revascularization are effective with good mid-term patency.
- Thank you, thanks for the opportunity to present. I have no disclosures. So, we all know that wounds are becoming more prevalent in our population, about 5% of the patient population has these non-healing wounds at a very significant economic cost, and it's a really high chance of lower extremity amputation
in these patients compared to other populations. The five-year survival following amputation from a foot ulcer is about 50%, which is actually a rate that's worse than most cancer, so this is a really significant problem. Now, even more significant than just a non-healing wound
is a wound that has both a venous and an arterial component to it. These patients are about at five to seven times the risk of getting an amputation, the end patients with either isolated venous disease or isolated PAD. It's important because the venous insufficiency component
brings about a lot more inflammation, and as we know, this is associated with either superficial or deep reflux, a history of DVT or incompetent perforators, but this adds an increasing complexity to these ulcers that refuse to heal.
So, it's estimated now about 15% of these ulcers are more of a mixed etiology, we define these as anyone who has some component of PAD, meaning an ABI of under point nine, and either superficial or deep reflux or a DVT on duplex ultrasound.
So we're going to talk for just a second about how do we treat these. Do we revascularize them first, do we do compression therapy? It has been shown in many, many studies, as with most things, that a multi-disciplinary approach
will improve the outcome of these patients, and the first step in any algorithm for these patients involves removing necrotic and infected tissue, dressings, if compression is feasible, based on the PAD level, you want to go ahead and do this secondary, if it's not, then you need to revascularize first,
and I'm going to show you our algorithm at Michigan that's based on summa the data. But remember that if the wounds fail to heal despite all of this, revascularization is a good option. So, based on the data, the algorithm that we typically use is if an ABI is less than point five
or a toe pressure is under 50, you want to revascularize first, I'll talk for a minute about the data of percutaneous versus open in these patients, but these are the patients you want to avoid compression in as a first line therapy.
If you have more moderate PAD, like in the point five to point eight range, you want to consider compression at the normal 40 millimeters of mercury, but you may need to modify it. It's actually been shown that that 40 millimeter of mercury
compression actually will increase flow to those wounds, so, contrary to what had previously been thought. So, revascularization, the data's pretty much equivocal right now, for these patients with these mixed ulcers, of whether you want to do endovascular or open. In diabetics, I think the data strongly favors
doing an open bypass if they have a good autogenous conduit and a good target, but you have to remember, in these patients, they have so much inflammation in the leg that wound healing from the surgical incisions is going to be significantly more difficult
than in a standard PAD patient, but the data has shown that about 60% of these ulcers heal at one year following revascularization. So, compression therapy, which is the mainstay either after revascularization in the severe PAD group or as a first line in the moderate group,
is really important 'cause it, again, increases blood flow to the wound. They've shown that that 40 millimeters of mercury compression is associated with a significant healing rate if you can do that, you additionally have to be careful, though,
about padding your bony areas, also, as we know, most patients don't actually keep their compression level at that 40, so there are sensors and other wearable technologies that are coming about that help patients with that, keeping in mind too, that the venous disease component
in these patients is really important, it's really important to treat the superficial venous reflux, EVLT is kind of the standard for that, treatment of perforators greater than five, all of that will help.
And I'm not going to go into any details of wound dressings, but there are plenty of new dressings that are available that can be used in conjunction with compression therapy. So, our final algorithm is we have a patient with these mixed arterial venous ulcers, we do woundcare debridement, determine the degree of PAD,
if it's severe, they go down the revascularization pathway, followed by compression, if it's moderate, then they get compression therapy first, possible treatment of venous disease, if it still doesn't heal at about 35 weeks, then you have to consider other things,
like biopsy for cancer, and then also consider revacularization. So, these ulcers are on a rise, they're a common problem, probably we need randomized control trials to figure out the optimal treatment strategies.
- Thank you, Dr. Ouriel, Dr. Lurie. Ladies and gentlemen. Brian, that was a very fair overview of the ATTRACT trial as it was published in the New England Journal, so thank you. And these are my disclosures. So Dr. DeRubertis did a very nice review of this paper
that was published in the New England Journal December 7th of last year. He went over very nicely that it was NIH sponsored, phase III, randomized, controlled, multicenter, 692 patients randomized, anticoagulation alone versus anticoagulation plus catheter-based techniques.
Now one thing I want to call your attention to is the fact that patients with deep venous thrombosis, acute deep venous thrombosis, who were eligible for randomization, were stratified before they were randomized into two different groups, iliofemoral DVT or fem-pop DVT.
So in my opinion, these are not subgroups because the randomization of one group had no effect on the randomization of another, so I would argue that these are independent groups. That makes a big difference when you do statistical analyses.
The other important issue that I want to point out is that the outcomes were pre-determined to what we were going to analyze. We had to choose one as a primary endpoint and the others as secondary, but these were pre-determined end points that were up for analysis, not post hoc analyses.
And post-thrombotic syndrome was determined at the time, 12 years ago when we wrote the protocol, to be the primary end point. I would submit that we would not choose that as a primary end point if we wrote the protocol today. Moderate to severe post-thrombotic syndrome
certainly would be more appropriate. Leg pain, swelling, health-related quality of life, certainly important. This is the outcome, and unfortunately, it did not reach significance. There was no difference between the two groups
and there was an increased risk of bleeding, but this is the outcome that drove opinion about ATTRACT, but we don't really do catheter-directed thrombolysis for fem-pop DVT. Therefore, the results of the iliofemoral patients will be the most meaningful and that paper was written
and that paper has been accepted by circulation. It should be out shortly, but there were 391 iliofemoral DVT patients and the primary outcome was no different than the primary outcome in the overall trial. But are they?
If we had chosen the Venous Clinical Severity Score in place of the Villalta score for analysis of that primary end point, it would've been a positive study. So if we chose a different tool to analyze, our primary end point would've been positive for the iliofemoral DVT patients.
If we look at moderate to severe post-thrombotic syndrome, a significant difference. Control patients had a 56% increased risk of moderate to severe PTS versus the control patients. If we look at severe post-thrombotic syndrome, control patients had a 72% increased risk
of severe PTS versus control. If we look at the overall severity of the Villalta score in PTS, we can see that there is a significant difference favoring percutaneous catheter-directed thrombolysis. When we look at pain, the patient's pain was significantly reduced in the PCDT patients compared to control.
We look at edema, significant reduction in edema at day 10 and day 30 in patients who received catheter-directed thrombolysis compared to control. Disease-specific quality of life significantly favored patients who had PCDT compared to control. So we look at moderate to severe, severe, pain,
quality of life. There was a price to pay. Major bleeding was increased, but the P-value was no different. I will not argue that patients are not at increased risk. They are at increased risk for bleeding,
but this is an historically low bleeding rate for catheter-directed thrombolysis and there were no intracranial bleeds. No difference in recurrent deep venous thrombosis. No difference in mortality at 24 months between the two groups.
So in conclusion, the primary end point, reduction of any PTS defined by a Villalta score of 5 or more, no difference, but an item that has not reached the level of discussion that we will need to consider is that 14% of our patients had a normal Villalta score coming into the study.
It's impossible to improve upon that, but there is a significant reduction in any PTS if you use the Venous Clinical Severity Score, reduction of moderate and severe post-thrombotic syndrome, reduction of pain and swelling, and improved disease-specific quality of life compared to controls.
And I think these are the meaningful end points that patients appreciate and these are the points of discussion that will be covered in the article in circulation that will be published very soon. Thank you for your attention.
- Thank you again, Dr. Veith, for the kind invitation to talk about this topic. This year, these are my disclosure. In the last five years, we treated 76 cases of Fenestrated and Branched repair for torque abdominal unfit for open surgery. And we soon realized that the upper extremity access
is needed in almost up to 90% of the cases. The first cases were managed by standard cut down in high-brachial and brachial region, but as soon as we improved our skills in percutaneous approach for the groins, we moved also in a transaxillary and percutaneous access
in the area. What we learned from the tanvis group of Hamburg is that the best spot to puncture the artery is the first segment, so the segment within the clavicula and the pectoralis minor. And to do so it is mandatory to use an echoguidance
during the procedure. Here you can see how nicely you can evaluate your axillary artery and avoid puncture the artery through the pectoralis minor where there are nerves and collaterals and also collaterals of the vein. Here is short video you can see I'm puncturing
the axillary artery just below the clavicula with a short guide wire, we introduce 6 French sheath and then we place two proglides according to the instruction for use of the device for the femoral artery. And at the end we usually put a 9 French short sheet
and then we start the procedure. As soon as we are finished with the main body of the, finished with the graft and we have bridged all the vessels from below, we downsize the femoral access but we keep in one groin a 7 French sheath
in order to perform then the final closure. What we do as soon as we are finished the complete procedure we snare a wire from the femoral artery we push the seven French sheath in the axillary artery, we pull back the 12 French sheath in the axillary artery and then we are ready to unlink the two sheath
and so we push a wire in the axillary, from the axillary in the aorta, and one wire in the arm. So that we can deploy a balloon which is sized according to the axillary artery diameter we inflate the balloon and we remove the 12 French sheath and now it is possible to tie the knot of the proglide
over the balloon without any worry to have bleeding and we check with the wire then we remove the wire and then we tie the know of the proglide again. And we ensure that there is no defect and leaking on this region. We have done so far 50 cases and they are
enrolled in this study which is almost completed. And here you can see the results. We have mainly punctured the left side of the axillary, you can see that nicely the diameter of the axillary artery in this region is 8.9 millimeter the sheath size was mainly the 12 French
but we also use sometime the 16 in cases which on iliac was not available. And we also punctured the artery if there was a pacemaker or previous scar for cardiac operation. And here are the results you can see we had no open conversion, the technical success
was 92% of the cases because we are to deploy three cover stent to achieve complete sealing and one bare stent to treat dissection distally to the puncture site. We didn't have any false aneurysm on the follow up and arterial thrombosis and no nerve injuries
in the follow up. So for the discussion, if you look on the research where there are different approach in the discussion is called either to go for the first or the third segment we believe that the first segment is better because it is bigger, is more proximal
and there are no nerves in this region. And by proximalizing the approach you can also work from the right side of your patient so you don't need the guy left side of the table. Moreover, by having the 12 and the standard 19 seven french sheath you can enhance your pushability
here you can see that the 12 french sheath arrives close to the branch of renal artery and the seven french sheath is well within the renal branch. And here you can see where the hands of the operator are. Of course if you enhance this technique you can downsize contra arterial femoral sheath
needed to reach three vessels so maybe lowering your risk of limb ischemia and paraplegia and if you insert this approach in the femoral percutaneous approach, you can see that you can cut down your procedural time your OR occupation time and also
the need of post operative transfusion. So dear chairman and colleagues in conclusion, in our experience the first segment is the way to go. Echo guided puncture is mandatory. Balloon assisted removal is the safest way to do it. Our results prove that it's feasible and safe.
There are different potential advantages over branchial and cutdown. And we hope to collect more data to have more robust data to support this approach. Thank you.
- A little bit away from below the knee to the the fem-pop area The PQ, percutaneous transvenous arterial bypass procedure's also something to go into the vein, but then not stay in the vein like with a limb procedure. But, go back into the artery. This is not completely new.
But during the last years, studies have been ongoing and there are some data now which will be presented by the next speaker. My task is now here to show you once again the procedure and the concept.
So, this is meant as a fully percutaneous stent graft bypass It originates in the proximal SFA, then goes from the artery into the vein over our distal to the occlusion. Goes back into the distal SFA or popliteal arteries. This is really a concept for very complex lesions
CTOs, long CTOs, in stent re-occlusions which can not be open any more. Dense calcification, and by this, I think the results which we can achieve with this should also be compared with endovascular treatment, or other treatments with these kind of complex lesions.
So, for this procedure, the company has produced some specific materials like stent grafts, long stent grafts. This is a snare tool to catch the wire in the vein
and a re-entry device similar to now what they call a PI Catheter. These are the accesses which are needed. An eight French to go cross over to the proximal SFA, and a tibial venous puncture to take a seven French sheath. And, here's the arteriography showing this
extremely calcified, long SFA occlusion. This is the level of the groin. The phlebography here where we should meet from artery to vein. And, this here is the re-entry system which with a spring, shoots the curved needle here
from the artery into the vein where this snare, this basket like snare, is waiting for that needle to catch the wire. And, then this snare can be closed. The wire will be pulled down here to the distal vein. Of course, the next step will then be a pre-dilatation here.
And, thereafter, usually you do not see any bleeding. But this is now meant to take here the re-entered device down to distal to the occlusion to again here puncture from the artery into the vein. Here, that snare basket sort of serves as stabilization
for that re-entered device. And, then the wire here has to be taken here into the distal open artery to eventually pre-dilate also here. And, then to take cover stents from the artery through the whole vein up to the artery here again.
And this is here the angiographic result. So, this is clearly not a very complex procedure. It's actually relatively simple to do. And, therefore, this is really in contrast to the complexity of the lesions which are treated. You can also do phlebography shown here that
the graft is not occluding the vein here. No risk of venous thrombosis. This here is a 50 month result here in this same case. So, the proof of concept comes from Dr. Joye who, was so to say, the inventor of this procedure. he used off the shelf devices.
You can see these were really all very complex long lesions here. Some long term outcomes here. You can see the primary patency after one year being 82%, and after some years stabilizing here between 60% and 70%.
I think, very important to see here that out to 4 years, there were no objective venous morbidity with a graft here being in the vein. Now, some data from the first study which will be shown in the next slide. And, also the next study more in detail just briefly.
Very complex lesions here. 81 cases were treated here with very acceptable primary patency according again to the complexity of the lesions. And a very good secondary patency, and also, a very good safety of this procedure.
Lessons which could be learned here from the first study were that also here with this graft, We can see edge re-stenosis. So, we have to be careful that these from the proximal part to take it high enough. I think this will help here that these stats here
extending a little bit that covered part here to give stabilization here from a bifurcation. Thank you very much.
- Frank, thank you very much for your invitation. This is my disclosure. I think that all vascular surgeons are asking ourself following question. Is diameter of triple A the sole indicator for surgery? To ask for this question since about 20 years, we are interesting with function in aging with a PET CT
using 18F-FDG which allows the evaluation of the regional glucose metabolisms. And shows the presence of an inflammatory reaction at the level of atherosclerotic tissue infiltrated by the inflammatory cells. During our pilot study, we observed that
the uptake of the FDG was also stated with the unstable triple A. And during several studies, we were observed that FDG uptake not only show of predicted rupture but it predict also the site of the rupture
in triple A patients in Thoracic Aortic Aneurysms as well as Aortic Arch Aneurysm as you can see. Here is very easily we are find, you can observe FDG uptake and this patient we performed MRI and you can see here, free iron particles, it's same area of every velope. Starting increase FDG uptake
and this patient refused operation and come back three months later to rupture. Of course FDG is not specific for aneurysm or disease. We can found FDG uptake in cancer disease, infection or arthritis or arthritis and reason why several authors interested with different kind of biomarkers
and sodium fluoride F 18 each one of those one. And it's injections indicated for diagnostic PET imaging of bone to define areas of altered osteogenic activity. The primary clinical use of sodium fluoride PET is in detection of osseous prostate cancer metastasis. But some authors, all of them start to use it for
evaluation of the plaque metabolism in high cardiovascular risk subjects. One group from United Kingdom and leaded by a Dr. Newby from Cambridge, they performed several very nice studies using this marker in coronary artery disease for plaque rupture
and for evaluate aortic stenosis to accumulation of the calcification in the aortic leaflets. And also for carotid stenosis and they, during this several studies, they demonstrated that 18F sodium fluoride, selectively binds to microcalcification coronary
and carotid atherosclerotic plaques and that are associated with plaque vulnerability and rupture. More essentially he interested, they interest also the triple A and they called this study the SoFIA study and it concern about 72 cohort patients
and 20 study population. And it is very nice picture of the patients with positive 18F sodium fluoride uptake. It is specific for one and reason why it is left right in red color here, but anyways, very easy to show the infusion images uptake
at the symptomatic aneurysms. And they divided their cohort study in three levels of Tertile 1, Tertile 2, Tertile 3 according to sodium fluoride uptake from low uptake to increase uptake and they observed that the growth rate,
increased growth rate, aneurysm repair and rupture and aneurysm repair alone, it was significantly higher in the patients in Tertile 3 group. And they concluded that Fluorine-18 sodium PET-CT
is a novel and promising approach to the identification of disease activity in patients with triple A and is an additive predictor of aneurysm growth and future clinical events. My conclusion is 18F-FDG and 18F Sodium Fluoride however,
not specific for inflammation. Therefore, new imaging tracer for a more accurate inflammation detection and therapy evaluation are needed. We need specific markers of angiogenesis and inflammation to predict the triple A evolution and potential rupture.
Thank you very much for your attention.
- Thank you, Doctor Chuter. So, as you saw in Eric's presentation, really indwelling catheters and wires have become more or less routine for us. And they're nothing new to this era of complex and vascular repair. We've seen them a long time and
we started using them, of course, for iliac branch devices, as you can see here. And the concept is the same when you use them for other branches or fenestrations, as I'll show you. And here, an iliac branch is coming over with that indwelling catheter and snaring
from the contralateral end to be able to get that sheath. This is a helical-helical device, so putting that sheath over to get access to the contralateral side. So why and when do we need preloaded grafts with wires or catheters for complex aortic repair? Well, sometimes we have access issues
and it alleviates that, as I'll show you. Having the fenestrations or branches pre-catheterized will intuitively reduce X-ray exposure times and operating times, and also help catheterization in difficult anatomy, as Eric alluded to, and thereby
keeping the procedure down and avoiding large sheaths in both groins, at the same time minimizing lower-extremity ischemia time. This is an example of putting a fenestrated device in a previous infrarenal device. And the multitude of markers here
makes it very difficult to actually locate the fenestrations on the new graft, so it's very advantageous in these settings to have the fenestrations preloaded. This was first described by Krassi Ivancev back in 2010, and this is the original
preloaded design for a juxtarenal fenestrated device. And you can see a loop wire going through the top of that device. And a very simple handle with a couple of wires and things coming out of it, and some technical difficulties with wire catches
and other things made us move away from that design. It was later evolved into this bi-port delivery system, which allows you to have access to two fenestrations from a unilateral approach with indwelling renal wires and then sheaths, and having
those wires go through the renal fenestrations. And this evolved into the p-branch off-the-shelf fenestrated device from Cook, as you can see here. And you can see that loop wire coming out through that right renal fenestration
going through the top of the graft. And this is the catheter just describing how you then can use a double-puncture technique to access that renal artery and place the sheath there. The advantages of the technique
was described by Doctor Torsello's group in Munster here, showing that it does in fact reduce the amount of radiation in contrast during these procedures as well as bringing the procedure time down. And this was described by Mark Farber as well
in the experience of the off-the-shelf p-branch devices. We modified the preloaded device a little bit further by taking away that very top stent, and instead of having the loop wire is on the p-branch, just placing catheters through those fenestrations,
but still using the triport handle, and then replacing those with 018 wires to achieve stable positions. Of course, preloaded catheters and wires can then be used for branch procedures as well, as Eric Verhoeven just showed you. And in this case, just using these
indwelling catheters to allowing wires to be snared from above and then advanced into the specific branches and distal arteries. And of course, if you use a fenestrated device for thoraco-abdominal repair, the same applies. And this is from Carlos Timaran's paper
just showing how he places these wires from above in these discrete fenestrations. This is a combined device of a two-branch, two-fen device, if you would like, that has indwelling wires going through the fenestrations and out
through the branches, which we use on occasion. You can then bring that out through the axillary artery, and you get access directly from above to the branches from below for the fenestrations. And we found it very useful in the setting of narrow aortic
lumens and chronic aortic dissections, as in this case. And you can see here, then, on the wires placing the sheath, catheterizing the renals, and then at the same time, having these access catheters in the branches so you don't have to access those for a nice end result.
So in summary, Chairman, ladies and gentlemen, preloaded wire I think reduces the operative time and the X-ray exposure during these procedures. It's very useful, particularly in complex torturous aortas, during redo EVAR cases with preexisting devices, and
compromised iliac access, and in the situations of narrow aortas, like in chronic aortic dissections. Thank you very much.
- Again, I think I'm going to continue the theme here on talking about REBOA technologies and techniques, so thank you, Dr. Veith, again for allowing us this format. No disclosures on my part. Everyone by now has heard this term multiple times and I think this is a community that understands
Resuscitative Endovascular Balloon Occulsion of the Aorta. Not new technology, very familiar to everyone in this audience who frequently is called upon to deal with the ultimate model of noncompressible hemorrhage,
that of the rupturing abdominal aortic aneurysm. Dr. Veith showed us many years ago that we could get appreciable outcomes improvement with endovascular balloon occlusions here, and the military was certainly listening. Colonel Rasmussen developed this paper
describing the first techniques. The diagram on your left, one of our first civilian centers, in a classic military-civilian collaboration, that we rolled this out at at Shock Trauma, this is the algorithm that is utilized there and it has been exported to countless trauma centers
for incorporation into their own protocols. And, as it was also mentioned, the American Association for the Surgery of Trauma AORTA Registry is capturing these prospectively. We now have 34 centers and over 568 REBOAs captured as of November 2018.
And this hopefully will continue to provide us some of the data that we need to better differentiate optimal patient selection and optimal practices. So, again, another encouraging anyone in the audience to likewise contribute to those 34 centers. And we have evolving advances in technology, clearly,
some of that has been discussed about here already. And better understanding through the Endovascular Resuscitation Trauma Management Society, and other meetings like that, to look at procedural approaches that work and share knowledge across the full spectrum.
We have lower profile devices. We have the ability to monitor the patients to step up care in a stepwise fashion to optimize the survival of bleeding patients. The old Coda balloon we initially utilized for this approach for REBOA back when I started doing this in about 2008 was,
or 2009, was has largely been replaced by these military specific civilian and trauma specific technologies that Colonel Rasmussen mentioned briefly. The REBOA in 2018, the majority of centers coming on board from the trauma center perspective or utilizing the prime time ER REBOA catheter,
this is FDA approved for floroscopic, for use. It is 7 French compatible, has a distal arterial pressure monitoring port distal to the balloon, does not require a guide wire, and is exceedingly user-friendly for the majority of the people who are going to be putting these in,
which is the acute care trauma surgeon who's at bedside when these patients arrive. The techniques that we utilize and we teach in our American College of Surgeons Basic Endovascular Skills for Trauma course, our best course, which is our current standard for training of REBOA
to trauma and acute care providers and, increasingly a larger subset of providers, utilizes external landmarks. And this has been shown through both CT morphometric studies and clinical applications to be a very reliable modality in that patient who is actively
attempting to code in front of you. And Colonel Rasmussen also touched on our growing experience here. The Northern paper was really a banner presentation and an eye-opening report for we, as military providers, and the trauma community, with their 100 percent
survival to the next echelon of care. We've learned a lot from these groups and their ability to employ this device effectively in really a resource-limited environment where they don't have blood providers become a resource that is very limited.
It's a challenging environment and they were able to deploy this quite effectively. And, more recently, the Tactical Combat Casualty Care committee has released guidelines for utilizations technology across a wider spectrum of small, not just surgical teams,
but also resuscitative teams. These are some of the pictures of some of the crews that I deployed with recently. And we are small team living out of a backpack with very limited blood utilization. And having this capability in your backpack,
to get that patient to more of a hard stand definitive surgical facility is a game-changer for all of these types of providers put in these situations across huge geographic footprints including Africa and parts of the Middle East.
Refinement of techniques is also continuing to evolve. Tal Horer talked briefly about partial REBOLA, this is how I utilize this technology. In a more refined fashion, utilizing a manual compression of the balloon to titrate a blood pressure that keeps the heart and the brain happy
with normal tension and keeps the operative field until definitive surgical control's obtained in hypotensive resuscitation state. So we're not disrupting clot, we're not causing more bleeding and propagating the deadly triad with ongoing cuagulopathy.
It's a wonderful tool, wonderful approach, I think. This is how it works. To some degree you can see the surgeon, the REBOA catheter in place, that was placed before the abdomen was opened. The surgeon actively working to obtain definitive control.
And we have here the balloon, the pressure in the balloon, the monitoring port above the balloon. This is the pressure below the balloon, as measured off the side port of the 7 French sheath. So now I'm able to titrate a pressure that minimizes the risk of hypotension
for the brain, the heart, those critical organs, yet perfuses the distal organs to a safe degree so that we don't have that reperfusion payback after subsequent definitive surgical control's obtained. And this technology continues to grow across a wide spectrum of indications,
non-trauma hemorrhage indications. When you look at global health burden, post-partum hemorrhage is more likely, in 10 years, to benefit from the further integration of REBOA, than any trauma bleeding that we encounter. That's really just a huge global health burden
and there's an active community in both the U.S. and South America developing registries for implementation there and partnerships across multiple specialties. And there's now actually an NIH funded, clinical research project in development
to look at the use of these balloons in CPR, those patients in Vfib that are not refractory to electroshock, and to see if we can salvage some of those patients. So that is also in effect. Some conclusions, REBOA continues to evolve
for applications for trauma and has evolving opportunities, as well, in non-trauma areas and wider utilization is going to continue to be facilitated by continued device improvements, training and research. Thank you.
- 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.
- 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 going to be talking about allografts for peripheral graft infections. This is a femoral artery that's been replaced after a closure device infection and complication, and we've bypassed to the SFA and profunda femoris. These are my disclosures. So peripheral arterial infectious processes,
well the etiology either is primary or secondary. Primary can be from bacteremic states and seeding of ulcerated plaque or thrombus. Secondary reasons for infections can be the vast usage of percutaneous closure devices that really have flooded the market these days.
Prosthetic graft infections after either a bypass or patch in the femoral artery. So early onset infections usually are from break in sterility. Secondary infections can be from either wound breakdowns or late seeding of the prosthetic graft.
The presentation for these patients can be relatively minor such as cellulitis or draining sinus, or much more dramatic, such as sepsis or pseudoaneurysm or mycotic aneurysm. On the CT scan we can see infected mycotic aneurysm after infected closure device and bleeding complications.
The treatment is broad in range. Ligation is obviously one option, but it leads to a very high risk of major limb amputation. So ideally some form of reconstruction, either extra-anatomic through clean planes,
antibiotic graft as we heard from the previous speaker, the use of autologous replacement with deep vein, or we become big proponents of the use of cryopreserved arterial allografts for reconstruction. And much of this stems from our work from about 10 years ago, where we looked
at the use of aortic cryopreserved grafts for aortic graft infections. This was published about 10 years ago but we looked at a small series of patients with aortic infections. You can see the CT scan of an infected stent graft
and associated aneurysm. And then the intraoperative photo after we've resected the stent graft and replaced that segment of the aorta with a cryopreserved aortic segment. So using that as a springboard,
we then decided to look at the outcomes using these types of conduits, arterial conduits, for peripheral arterial reconstructions in contaminated or infected surgical fields. So retrospective review at our tertiary care center, we looked at roughly 60 patients over a 15-year period
and excluded any aortic-based reconstructions. So these are all peripheral reconstructions. Mean follow-up was 28 months. As you would expect, the distribution of treatment zones were primarily in the lower extremities, so 51 cases.
As you can see, there's a list of all the different types of cases that we treated. But then there were a few upper extremity visceral and then carotid. I've shown this slide before at this meeting in the past, with a carotid patch infection
that was treated after it had a blow-out, and it's obviously a infected aneurysm, and this was treated with resection and a cryopreserved arterial segment. Looking at our outcomes, the 30-day outcome showed a mortality rate of 9%.
The 30-day conduit-related complication rate was surprisingly low at 14%. We had four patients that had bleeding complications, four patients with recurrent infectious complications. All eight of those patients required a return back to the operating room for correction.
The late conduit-related complication rate was only 16%. As listed here, you can see there's only one case of reinfection, three cases of graft thrombosis, surprisingly only one major limb amputation, two pseudoaneurysms and one late bleeding complication.
And graphically depicted, you can see here, this area here is looking at the less than 30 days, this is primarily when the complications occur. When you get to six months, fewer complications, and then beyond six months, the primary complications that we would see are either thrombosis of the graft
or the development of late pseudoaneurysms, again relatively low. So in summary, I think peripheral arterial infectious complications can be treated with a cryopreserved arterial allografts. The advantage is it's a single stage operation,
maintains in-line flow, there's a low incidence of repeat infection. I think it's also important to mention that the majority of these patients had adjunctive muscle flap coverage to cover the large soft tissue defect
at the time of the operation. So I think that this is a valuable alternative conduit in a setting of peripheral arterial infections. Thank you.
- So in terms of overcoming difficult access, when we're doing parallel grafting, and we're going to use more than one branch or parallel graft, typically we come in from the axillary artery. It gives good pushability, it decreases the length for what you need to get from you access point
down to the branch vessels. We find that no conduit is needed. We typically just access this in three offset manners. We'll put a purse string in at each site, so that there's limited bleeding. When you come in, you have to think about
what the aortic arch construct looks like. You can have a type one, a type two or type three arch, which can make things more difficult. As you can see here, this sheath takes quite a significant bend to get down to the renal visceral segment.
You also can have tortuosity within the thoracic aorta, which can compromise your ability to cannulate. So when we think about the arch, you want to think about coming in from the right or left, which ever one makes it better. Typically, if all things are equal,
we'll come in from the left side. When you get your sheaths down one at a time, we leave the stiff wire in to try to straighten out the anatomy. Sometimes you have to snare and get through and through access.
And then you want to think about where your sheaths position is. You want it to be high enough so that you can allow your catheters to form, but also low enough so that you can reach the vessel of interest.
There are a couple of things, I think from a pre-planning perspective that are very important to try to set up, to allow yourself the optimal chance of cannulating these vessels. Appropriate C-arm projections, you want to think about
whether or not your going to use a cephalad or caudad parallel graft. Think about the tortuosity as well as the composition of the branch. What type of stent are you going to use in that? How much purchase is needed?
How much purchase can you get? And, How difficult is it going to be to cannulate these vessels? And also whether or not there's orifice stenosis. So, here's an example of a patient we did. You can see that left renal artery
is actually quite anterior. If you look at the AP view here, you can see how it would be quite difficult to cannulate, 'cause the orifice basically runs into the aneurysm in the AP view, if you just move your II to a 30 degree RAO,
then it becomes very perpendicular and very easy to cannulate and see. This is a situation where you think about periscoping or caudad parallel graft. It's much easier coming from below, it's an upwards approaching renal artery.
Coming from above, you can see it can bow out towards that large aneurysm and also potentially reflux down into infra-renal segment. This is a patient with a very short branch of main renal artery, and you can see if you just put
a typical self expanding stent, there's a higher chance that this thing's just going to pull out into the aneurysm, and what we did here is, we put a balloon mounted stent, followed by a self expanding stent
to lengthen afterwards and it worked out really nicely. And this is just the patient that has significant orifice stenosis and these patients will be hard to cannulate. Sometimes you have to pre dilate before you introduce your stents into the vessels.
You also want to think about the aorta and what configuration of the aorta is. What's the tortuosity, the calcification. Are you in a situation where you're trying to cannulate within the aneurysm and how much thrombus is there as well.
So, you can see here in the first picture, the aorta's somewhat tortuous, and going after that left renal artery probably would be easier, but going after that right renal artery becomes potentially difficult
as the catheters and sheaths are going to be pushing you away, and may make that more challenging. You may want to think about things, and certainly catheters selection before approaching. And definitely, any time you have an aneurysm
and your in a big space without a lot of thrombus, that makes things a little more difficult, 'cause you're flopping around in a large open space trying to cannulate a vessel. When you're accessing the vessel sometimes from above, what will happen is the tendency is
for the catheters and the wires, to reflux down into that infrarenal space. This is a no not well known trick, where you put a coda balloon and you can have your wires and catheters bounce off of that coda balloon
to help you navigate into that branch vessel. Sometimes that doesn't work, and it still continues to reflux, and what we've done more recently is, we'll come in from below, put a four millimeter balloon
in the distal renal artery, and then we'll pin our soft wire, be able to do a catheter exchange, exchange for our stiff wire, and ultimately, there's the catheter, ultimately in the stiff wire.
And then ultimately bring in your stent graft, all with that balloon still in place to hold and pin that wire in position, and allow things to track over that wire, rather than reflux down. Just some general thoughts, again,
thinking about the appropriate catheters, what length catheter do you need, what kind of angulation do you need, stiff versus angle glide wires. We typically use Rosen and Amplatz wires for our stiff wires to track our stents in.
And then different platforms, depending upon what your anatomy ultimately looks like. So in conclusion, a lot of pre-planning is important, I think to optimize your accessing of these vessels. And there's a lot of techniques and technology, that currently exist to help assist with this.
- Thanks again Dr. Greenhalgh, Dr. Veith. These are my disclosures. We first took on a systematic review and meta analysis on the risk of bowel ischemia after ruptured abdominal aortic aneurysm repair. We found the prevalence of 10%, and that's been very constant.
OR 11% open repair, twice as much as an EVAR. And it's incidence has been very constant over the years from 1995 to 2015 so this scatter plot shows we didn't learn anything on this subject in these years. So the diagnosis of colon ischemia
is difficult after ruptured aneurysm. And we sought to look how effective sigmoidoscopy is in the diagnosis. And towards that end, we did a retrospective cohort study from the AJAX-cohort I mentioned before. Patients who underwent ruptured aneurysm repair,
only those who had repair were looked at and three major referral hospitals. And those patients had to survive more than six hours after arrival in the ICU. We did sigmoidoscopy only on clinical suspicion. Sigmoidoscopy results were categorized as
no ischemia, inconclusive, mild ischemia, or severe ischemia grade two or three. Laparotomy was the reference standard to demonstrate no transmural ischemia. 345 patients were considered. 81 open repair, 19% EVAR.
80% were male. These were the ages. And the 30-day mortality in this entire group was 26%. So we looked at clinical suspicion for colon ischemia, and found 46 patients moderate, a big group no clinical suspicion,
and a small group of 16 patients with a high clinical suspicion. The no clinical suspicion group, no one turned out to have colon ischemia, and mortality in this group was 20%. When we look at the other end, the high clinical suspicion,
they had immediate laparotomy, so without colonoscopy, and transmural ischemia was found in 83% of these patients, and they had a mortality of 50%. But, of course, it's always the gray area, in the middle, that is interesting. And we came to this clinical suspicion when they had
bloody stools, septic profile, diarrhea, abdominal pain or distention, or unknown. And those patients with the moderate clinical suspicion, they received colonoscopy. Negative were 16 of them, mild colon ischemia were seen in 19,
and severe in 11 patients. They turned out to have transmural ischemia none of them in the negative. So the negative predictive value for sigmoidoscopy is really good. In the middle group with mild colon ischemia,
only two out of 19 turned out to have transmural ischemia. And the severe ischemia group, eight of 11 turned out to have transmural ischemia on operation. So there was a total of 10 patients in this group who turned out to have transmural ischemia.
So, in conclusion, Mr. Chairman, ladies and gentleman, sigmoidoscopy is highly effective in ruling out colon ischemia. So it can prevent unnecessary operations. And when in doubt, transmural ischemia detection increases with colonoscopy from 22 to 73%.
Thank you for your attention.
- The main results of the mid-term, I would call it rather than long-term, there were three years of the improved trial, were published almost immediately after the Veith Symposium last year. I have no disclosures other than to say this was a great team effort, and it wasn't just me,
it was all the many contributors to this project. I think the important thing to start with is to understand the design. This was a randomized trial of unselected patients with a clinical diagnosis of ruptured abdominal aortic aneurysm.
The trial was to investigate whether EVAR as a first option, or an endovascular strategy, would save lives compared with open repair. We randomized 613 patients quite quickly across 30 centers, and this comprised 67 percent of those who would have been eligible for this trial, so good external validity.
Survival was the primary outcome for this trial. This was assessed at 30 days, one, and three years. At 30 days as you can see there was no difference between the endovascular strategy group in blue, and the open repair group in red. However, already at 30 days we noticed
that of the discharges in the endovascular strategy group, 97 percent of these went home, versus only 77 percent in the open repair group. No significant difference in survival at one year, but now out at three years, the survival is 56 percent in the endovascular strategy
group versus 48 percent in the open repair group. This is not quite significant. If we look only at the 502 patients who actually had a repair of a rupture, the benefits of the endovascular strategy are much stronger. And a compliance analysis,
because there were some crossovers in this pragmatic trial, shows very similar results. And for the 133 women, these were the real beneficiaries of an endovascular strategy. The cumulative incidence of re-interventions to three years are shown here, and no difference between open
and endovascular strategy. And I'll dwell on these in more detail in a later presentation. But this did mean that there was no additional cost to the endovascular strategy over the three year period. I'd also like to point out to you that
apart from the re-interventions, the need for renal support in the early days was 50 percent more common after open repair. Patients had rather different concerns about their complications to clinicians. And when we discussed this with patients they were most
concerned about limb amputation and possibly unclosed stomas. All of these were relatively uncommon, but we had a great collaboration with the other two ruptured aneurysm trials in Europe, AJAX and ECAR. And we put our data together.
Took 12 months, and here you can see the very consistent results. That amputations are considerably less common after endovascular repair for rupture than open repair. We've just heard about quality of life. In Improve Trial there were real gains in quality of life.
Up to three years in the endovascular strategy group. And since costs were lower, this meant that this strategy was highly cost-effective. So in summary, at three years an endovascular strategy proves to be better than open repair. With better survival, higher qualities for the patients
in the endovascular strategy group, marginally lower costs, and it's cost-effective. And we've heard quite a lot even at this meeting about our new NICE guidelines in the UK. But an endovascular strategy is actually being recommended by them for the repair of ruptures.
And I think the most cogent reasons to recommend endovascular repair are the fact that it has benefits for patients at all time points. It gives them what they want: Getting home quickly, better quality of life, lower rates of amputation and open stoma,
and better midterm survival. Thank you very much.
- Here are my disclosures, none are relevant to today's talks. So what is the role of compressions stockings to prevent Postthrombotic Syndrome for patients with acute DVT? Well it's become rather complicated because as shown by recent studies,
it depends on what question is being asked. Question one is do compression stockings started at the time of DVT diagnosis prevent PTS, such as the Socks trial and other similar trials? Or question two, if you're already worn compression stockings for a period of time after DVT
and have not developed PTS, does stopping them increase the risk of developing PTS, such as the recent OCTAVIA and IDEAL trials? This is a meta-analysis that was done to address question one, namely the role of compression stockings started at the time of DVT diagnosis,
and this meta-analysis considered unblinded studies. The one blinded study, which was the Socks trial, and then attempted to combine that data, and you can see that if one looks at the unblinded studies there's suggestion of a 30% protective effect, or, excuse me, 40% protective effect.
The blinded study showed no effect of compression stockings. And combining all the studies together seemed to show about a 30% protective effect, however the confidence interval crossed one. There's very low confidence in this total estimate because of the substantial heterogeneity across studies.
And indeed, in their discussion, the authors point out the following: "We have very serious concerns about the unblinded studies because such designs may inflate treatment effects". And also, "differing results across studies suggest that the decision to use compression stockings
may be value and preference dependent for our patients". And we'll come back to that shortly. What about question two, if you've already worn compression stockings for a period of time after DVT, and you haven't developed PTS, does stopping them increase the risk of getting PTS?
There've been two new trials. One is the OCTAVIA study, of 518 proximal DVT patients. All wore compression stockings for one year after their DVT. If they were free of PTS at one year, they were randomized to continue for an additional year, or to stop.
And the results of this trial showed that stopping after one year was inferior to continuing for two years for the PTS outcome. On the other hand, we have the IDEAL study, of 865 proximal DVT patients. In this study, all patients wore compression stockings
for six months after proximal DVT, and if they were free of PTS at six months, they were randomized to continue for an additional 18 months, or to tailor continued use of stockings according to the Villalta score that was assessed every three months
at study follow-up visits. And the results of this trial showed that tailoring use after six months, which was the experimental arm, was actually non-inferior to continuing for 18 more months. So these results are interesting but somewhat conflicting. So how do I use compression stockings in 2018?
I don't routinely prescribe stockings to all of my proximal DVT patients. They can be difficult to apply, uncomfortable, expensive, and they need to be replaced every few months. And we all know that many patients won't wear them
in real life, especially if they have no symptoms whatsoever. And also, it's really not clear to me whether stockings prevent Postthrombotic Syndrome versus merely palliate symptoms of Postthrombotic Syndrome that has already developed.
And it may simply be as effective and more convenient and we may achieve better compliance if we ask our patients to start compression stockings at the time they develop symptoms of Postthrombotic Syndrome. I do however prescribe a trial of stockings
to any DVT patient, whether they have proximal or distal DVT who has residual symptoms after their DVT, and I'd continue them for as long as the patient derives symptomatic benefit or is able to tolerate them, and I certainly take patients' values and preferences into account
in making this decision. Moving on to the role of interventional treatment for patients with acute DVT. We have all heard and seen the results of the ATTRACT trial. Just very briefly, we know that the primary study outcome, any Postthrombotic Syndrome was not different
in the PCDT arm versus the No-PCDT arm. However, it did appear that PCDT reduced the risk of developing moderate or severe Postthrombotic Syndrome, and this was driven primarily by the subgroup with Iliofemoral DVT. In terms of short-term results, PCDT caused more
bleeding, major and any bleeding, and it caused statistically significant but clinically modest improvements in leg pain and leg swelling. Based on these results, what's the role of interventional treatment for patients with acute DVT? I would say that it's not indicated for routine use
in proximal DVT, it doesn't prevent Postthrombotic Syndrome, it does increase bleeding, and older patients above the age of 60 to 65 or more appear to be particularly poor candidates because of more bleeding and less efficacy. And further study in clinical use of these modalities
should be targeted. One would still consider PCDT in patients with severe symptoms, Iliofemoral DVT, and the other factors shown here on the slide. And finally, always remember that it's always an option to anticoagulate first for the initial
five to seven days if the limb is not acutely threatened. Thank you very much.
- I'd like to thank Dr. Veith for this kind invitation and the committee as well. So these are my disclosures, there's none. So for a quick background regarding closure devices. Vascular closure devices have been around
for almost 20 years, various types. Manual compression in most studies have always been shown to be superior to vascular closure devices mainly because there's been no ideal device that's been innovated to be able
to handle all sorts of anatomies, which include calcified vessels, soft plaque, etc. So in this particular talk we wanted to look at to two particular devices. One is the Vascade vascular closure device
made by Cardiva and the other is the CELT arterial closure device made by Vasorum in Ireland. Both these devices are somewhat similar in that they both use a disc. The Vascade has a nitinol disc
as you can see here that's used out here to adhere to the interior common femoral artery wall. And then once tension is applied, a series of steps is involved to deploy the collagen plug
directly on to the artery which then allows it to expand over a period of time. The CELT is similar in that it also uses a stainless steel disc as you can see here. Requires tension up against the interior wall of the common femoral artery.
Nice and tight and then you screw on the top end of the device on to the interior wall of the artery creating a nice little cylinder that compresses both walls of artery. As far as comparability is concerned between the two devices you can see
here that they're both extravascular, one's nitinol, one's stainless steel. One uses a collagen material, the other uses an external clip in a spindle-type fashion. Both require about, anywhere between three to seven minutes of pressure
to essentially stop the tract ooze. But the key differences between the two devices, is the amount of time it takes for patients to ambulate. So the ambulation time is two hours roughly for Vascade, whereas for a CELT device
it's anywhere from being immediate off the table at the cath lab room to about 20 minutes. The data for Vascade was essentially showing the RESPECT trial which I'll summarize here, With 420 patients that was a randomized trial
to other manual compression or the device itself. The mean points of this is that the hemostasis time was about three minutes versus 21 minutes for manual compression. And time to ambulation was about 3.2 hours versus 5.7 hours.
No major complications were encountered. There were 1.1% of minor complications in the Vascade versus 7% in the manual compression arm. This was actually the first trial that showed that a actual closure devices
had better results than manual compression. The main limitations in the trial didn't involved complex femoral anatomy and renal insufficiency patients which were excluded. The CELT ACD trial involved 207 patients that were randomized to CELT or to manual
compression at five centers. Time to hemostasis was anywhere between zero minutes on average versus eight minutes in the manual compression arm. There was one complication assessed at 30 days and that was a distal embolization that occurred
early on after the deployment with a successfully retrieved percutaneously with a snare. So complication rate in this particular trial was 0.7% versus 0% for manual compression. So what are some pros and cons with the Vascade device?
Well you can see the list of pros there. The thing to keep in mind is that it is extravascular, it is absorbable, it's safe, low pain tolerance with this and the restick is definitely possible. As far as the cons are involved.
The conventional bedrest time is anywhere between two to three hours. It is a passive closure device and it can create some scarring when surgical exploration is necessary on surgical dissections.
The key thing also is you can not visualize the plug after deployment. The pros and cons of the CELT ACD device. You can see is the key is the instant definitive closure that's achieved with this particular device, especially in
calcified arteries as well. Very easy to visualize under fluoroscopy and ultrasound. It can be used in both antegrade and retrograde approaches. The key cons are that it's a permanent implant.
So it's like a star closed devised, little piece of stainless steel that sits behind. There's a small learning curve with the device. And of course there's a little bit of discomfort associated with the cinching under the (mumbles) tissue.
So we looked at our own experience with both devices at the Christie Clinic. We looked at Vascade with approximately 300 consecutive patients and we assessed their time to hemostasis, their time to ambulation,
and their time to discharge, as well as the device success and minor and major complications. And the key things to go over here is that the time to hemostasis was about 4.7 minutes for Vascade, at 2.1 hours for ambulation, and roughly an average
of 2.4 hours for discharge. The device success was 99.3% with a minor complication rate of .02% which we have four hematomas and two device failures requiring manual compression. The CELT ACD device we also similarly did
a non-randomized perspective single center trial assessing the same factors and assessing the patients at seven days. We had 400 consecutive patients enrolled. And you can see we did 232 retrograde. We did a little bit something different
with this one, we did we 168 antegrade but we also did direct punctures to the SFA both at the proximal and the mid-segments of the SFA. And the time to hemostasis in this particular situation was 3.8 minutes,
ambulation was 18.3 minutes, and discharge was at 38.4 minutes. We did have two minor complications. One of which was a mal-deployment of the device requiring manual compression. And the second one was a major complication
which was an embolization of the device immediately after deployment which was done successfully snared through an eighth front sheath. So in conclusion both devices are safe and effective and used for both
antegrade and retrograde access. They're definitely comparable when it comes, from the standpoint of both devices (mumbles) manual compression and they're definitely really cost effective in that they definitely do increase the
throughput in the cath lab allowing us to be able to move patients through our cath lab in a relatively quick fashion. Thank you for your attention.
- Thank you very much. So this is more or less a teaser. The outcome data will not be presented until next month. It's undergoing final analysis. So, the Vici Stent was the stent in the VIRTUS Trial. Self-expanding, Nitinol stent,
12, 14, and 16 in diameter, in three different lengths, and that's what was in the trial. It is a closed-cell stent, despite the fact that it's closed-cell, the flexibility is not as compromised. The deployment can be done from the distal end
or the proximal end for those who have any interest, if you're coming from the jugular or not in the direction of flow, or for whatever reason you want to deploy it from this end versus that end, those are possible in terms of the system. The trial design is not that different than the other three
now the differences, there are minor differences between the four trials that three completed, one soon to be complete, the definitions of the endpoints in terms of patency and major adverse events were very similar. The trial design as we talked about, the only thing
that is different in this study were the imaging requirements. Every patient got a venogram, an IVUS, and duplex at the insertion and it was required at the completion in one year also, the endpoint was venographic, and those who actually did get venograms,
they had the IVUS as well, so this is the only prospective study that will have that correlation of three different imagings before, after, and at follow-up. Classification, everybody's aware, PTS severity, everybody's aware, the endpoints, again as we talked about, are very similar to the others.
The primary patency in 12 months was define this freedom from occlusion by thrombosis or re-intervention. And the safety endpoints, again, very similar to everybody else. The baseline patient characteristics, this is the pivotal, as per design, there were 170 in the pivotal
and 30 in the feasibility study. The final outcome will be all mixed in, obviously. And this is the distribution of the patients. The important thing here is the severity of patients in this study. By design, all acute thrombotic patients, acute DVT patients
were excluded, so anybody who had history of DVT within three months were excluded in this patient. Therefore the patients were all either post-thrombotic, meaning true chronic rather than putting the acute patients in the post-thrombotic segment. And only 25% were Neville's.
That becomes important, so if you look at the four studies instead of an overview of the four, there were differences in those in terms on inclusion/exclusion criteria, although definitions were similar, and the main difference was the inclusion of the chronics, mostly chronics, in the VIRTUS study, the others allowed acute inclusion also.
Now in terms of definition of primary patency and comparison to the historical controls, there were minor differences in these trials in terms of what that historical control meant. However, the differences were only a few percentages. I just want to remind everyone to something we've always known
that the chronic post-thrombotics or chronic occlusions really do the worst, as opposed to Neville's and the acute thrombotics and this study, 25% were here, 75% were down here, these patients were not allowed. So when the results are known, and out, and analyzed it's important not to put them in terms of percentage
for the entire cohort, all trials need to report all of these three categories separately. So in conclusion venous anatomy and disease requires obviously dedicated stent. The VIRTUS feasibility included 30 with 170 patients in the pivotal cohort, the 12 months data will be available
in about a month, thank you.
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