- [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.
today's objectives I'll start with reviewing hepatocellular carcinoma HCC
and the current treatment options I'll share the protocol inclusion and exclusion criteria and I will discuss the research treatment protocol briefly and next transitioning to research the preparation taken in the department with
staff members for trial lastly I will talk about what's involved intraoperatively from a nursing standpoint so hepatocellular carcinoma HCC is the most common primary liver manely malignancy and is a leading cause
of cancer-related deaths worldwide cirrhosis is a condition in which there is scarring to the liver causing permanent damage chronic medical conditions such as diabetes mellitus and obesity lead to chronic liver disease
obesity is a risk factor to diabetes and diabetes directly affects the liver because of the essential role the liver plays in glucose metabolism both cirrhosis and chronic liver disease remain the most important risk factor
for the development of HCC a which viral hepatitis and excessive alcohol intake are the leading risk factors of cirrhosis non-alcoholic fatty liver disease and non-alcoholic steatohepatitis which is nash our
conditions in which fat builds up in your liver thus having inflammation and liver cell damage along with fat in your liver these are other risk factors for HCC the incidence of HCC will continue to escalate as hepatitis C and obesity
become more prevalent in the United States so unfortunately the diagnosis of HCC is too often made with advanced liver disease when patients have become symptomatic and have some degree of
liver impairment at this late stage there is virtually no effective treatment that would improve survival in addition the morbidity associated with therapies unacceptably high modalities available for HCC screening include both
radiographic tests and serological markers radiological tests commonly used for surveillance include ultra sonography multi-phase CT and MRI with contrast ultrasound has historically been utilized to identify intrahepatic
lesions since the early 1980s both the photograph above shows a cirrhotic liver versus a normal liver there are visible differences in the portal and hepatic veins between the cirrhotic liver when compared to the non cirrhotic liver so
AFP alpha-fetoprotein has been used as a serum marker for the detection of HCC an AFP level of less than 10 is normal for adults an extremely high level of AFP in your blood greater than 500 could be a sign of liver tumors liver function
tests or lfts look at the part of your liver that is not affected by cancer to see how well your liver is working the lfts will be considered for diagnosis and determining the stage of HCC the tests look for levels of certain
substance in your blood such as bilirubin albumin ALP ast alt and GGT despite advances in prevention techniques screening and new technologies in both diagnosis and treatment incidence and mortality
continue to rise so treatment options for HCC can be divided into three categories surgical options non-surgical options and systemic therapy patients are screened diagnosed and treated accordingly of
these three options interventional radiologists offer the non-surgical approach which include trans arterial embolisation percutaneous ethanol injection radiofrequency ablation and microwave ablation so I want to talk
about the child pu classification the child pious core consists of five clinical measures and is used to assess the prognosis of liver disease and cirrhosis including the required strength of treatment and necessity of
liver transplant the child piu score was originally developed in 1973 to predict surgical outcomes in patients presenting with bleeding esophageal varices today it continues to provide a forecast of the increased increasing severity of
your liver disease and you're expected survival rate the Chao few score is determined by scoring five clinical measures of liver disease the five clinical measures are total bilirubin serum albumin prothrombin time ascites
and hepatic encephalopathy once scores are available in each of the five clinical measures all scores are added and the result is a child piu score their interpretation of the clinical measure is as follows so Class A would
be five to six points lease liver disease with one to five year survival weight at 95 percent Class B seven to nine points moderately severe liver disease one to five year survival rate at seventy five percent and Class C ten
to fifteen points most severe liver disease one to five year survival rate at fifty percent so which child pew scores do I our patients fall into for a research with the CPC and the majority of the HCC child pew scores a and B
seven with the survival rate of one to five years for 95% the best outcomes are achieved when patients are carefully selected for each treatment option regardless of the treatment approach
patients with HCC require a multidisciplinary approach to care to ensure optimal outcomes what we refer to as tumor board tumor board are meetings where specialists from surgery medical oncology radiation oncology
interventional radiology and others collaboratively review a patient's condition and determine the best treatment plan through this multidisciplinary approach patients have access to a diverse team of experts
instead of relying on a single opinion each specialty will have unique contributions to ensure optimal long term outcomes for patients with HCC so there are various algorithms for HCC treatment I actually have one on top of
the other there just to show you that if you're interested in the process you can look it up it's there's a few out there all right so how are the patients selected for treatment like I said tumor board and moving on now to the surgical
options there are two surgical options liver resection and liver transplant surgical resection is currently considered to be the definitive treatment for HCC and the only one that offers the prospect of cure or at least
long-term survival however most patients have unresectable disease at presentation because of poor liver function the overall resect ability rate for HCC is only 10 to 25 percent and even among those who undergo surgical
resection with curative intent there is a recurrence rate of it to 80% at five years post resection survival rates are in the range of 80 to 92% at one year sixty-one to 86 three years and 41 to 74 at five years
the most common sight of post resection recurrence is a remaining liver for patients who are not surgically resectable liver transplant is the only other potentially curative option virtually all patients who are
considered for liver transplant are unresectable because of the degree of underlying liver dysfunction rather than tumor extent down staging using local regional therapies can also be used to increase eligibility for orthotopic
liver transplant while on the transplant list patients disease progress and meeting criteria gets complicated so patients on the transplant list are and do get some other therapies
which I will later discuss so we're surgical resection is not possible for poor liver function liver transplant is a treatment of choice prior to 2008 no systemic therapy was available that demonstrated an improvement in survival
with the publication of two randomized placebo-controlled phase 3 trials the oral multi targeted tyrosine kinase inhibitor sorafenib has become the new standard of treatment for advanced HCC with an increased median survival from
seven point nine months and the placebo group to ten point seven months in the treatment group systemic therapy can be difficult to tolerate because of the side effects dose reduction or treatment interruption is often needed
despite the side-effects treatment is recommended and to be continued into a progression of the tumor is demonstrated the majority of diagnosed patients with HCC present with advanced disease oral therapy has taken two pills twice daily
equaling 400 milligrams B ID so interventional radiology it's like surgery only magic so I I always think about this when patients come in and pre-op beam and they think they're having surgery you know it's well a lot
of benefits to ir what we're doing so interventional radiology is where the magic happens and non-surgical approach procedures are performed percutaneous local ablation include ethanol injection and radiofrequency ablation microwave
ablation is utilized both percutaneously and intraoperatively and lastly there is trans arterial embolisation which depending on the embolization agent can either be chemo bland or radioisotopes percutaneous ethanol injection known as
Pei has a long track record and is very effective in destroying HCC tumors that are less than or equal to 2 centimeters in diameter performed under percutaneous ultrasound guidance a needle is placed into the tumor and absolute alcohol is
injected over recent years radiofrequency ablation referred to as RFA has largely replaced Pei at most centres RFA's also performed percutaneously advancing a specially designed electrode into the tumor and
applying radiofrequency energy to generate a zone of thermal destruction that encompasses the tumor and a 1 centimeter margarine surrounding liver RFA is thus preferable to ethanol injection for patients with solitary
tumors 2 to 4 centimeters in size for tumors smaller than 4 centimeters RFA can achieve initial complete response rates of over 90% in microwave ablation MWA microwaves are created from the needle to create small
regionals regions of heat the heat destroy the liver cancer cells RFA and microwave are effective treatment options for patients who might have difficulty with surgery or those whose tumors are less than one and a half inch
in diameter the success rate for completely eliminating small liver tumors is greater than 85% so can I get a show of hands from the audience on who what facilities are doing chemo embolization everybody pretty much are
you guys doing them next to the gentleman yeah okay so this is gonna be a boring review here alright so trans arterial embolisation a minimally invasive procedure performed to restrict to tumors blood supply it is performed
by advancing and angiography catheter into the branches of the hepatic artery supplying the tumor and injecting an agent mixed with orally contrast followed by a cluding agent known as beads the beads which range from 100 to
300 micrometers in diameter are carried by the circulation into the terminal hepatic arterioles where they lodge and include the vessel resulting in the schema tumor necrosis the procedure is done using moderate sedation patients
are monitored for 23 hours or less for pain and post embolization syndrome trans arterial chemo embolization thus is where the chemo therapeutic agent mixed with beads is injected to the tumor
these particles both blocked the blood supply and induced cytotoxicity attacking the tumor in several ways taste is the treatment of choice when the tumor is greater than four centimeters or there are multiple
lesions within the liver taste takes advantage of the fact that while the liver is refused by both the portal vein and the hepatic artery HCC survives its blood supply almost entirely hepatic artery tastes has been shown to
prolong survival in patients with intermediate stage HCC and objective responses were observed in the majority of patients tear trans arterial radioembolisation is a form of catheter directed internal radiation that
delivers small microspheres with Radio isotopes directly into the tumor y9t microspheres are administered and a procedure similar to taste the procedure has been shown to be safe and effective in cirrhotic patients with HCC the side
effects are usually well title tolerated one major advantage of y9t over taste is that it is indicated in the case of portal vein neoplastic thrombosis while taste traditionally has been considered a contraindication all right so there's
finally intraoperative considerations positioning for comb bean tpz photo
sensitivity EKG and lab draws and noting the time of tpz injection so i wanted to say a little bit about comb beam all right who has comb beam at their facility just a few less okay comb beam is medical imaging technique consisting
of x-ray computed tomography where the x-rays are divergent forming a cone the scanning software collects the data and reconstructs it producing what is termed a digital volume composed of three dimensional voxels of anatomical data
that can then be manipulated and visualized with specialized software on the left is a standard floral image and on the right is the comb beam so the red shows the vascular angiography the blue is a tumor and the yellow is a feeding
artery to the term or so dr. Abuja lays a B today is heavily involved with research so the procedure room with Combee was exclusively constructed for her so positioning for comb beam I believe
to be the bigger challenge initially comb being requires the patient to have their arms up high and using comb beam technology increases the procedural time it would be difficult for the patients to maintain that position and keep still
without anesthesia we started clinical trials with nurse assisted moderate sedation and soon learned it was very difficult the majority of our HCC embolization --zz are done with with sedation but we're
now using anesthesia for all of it so the lead in this case was Tom the radiology tech which assisted with the placement of the anesthesia equipment and patient positioning our anesthesia personnel are not only out of their
comfort zone in the I are sweet but unfamiliar with tpz trial and how the comb beam equipment rotates completely around the patient the patient is wearing two sets of leads one for anesthesia and the other for research
the leads are radio translucent to reduce artifact and imaging keeping the lid lid lead in the department took some getting used to one set got thrown away one set was found up in the ICU one set was on the
anesthesia equipment it was hard keeping track of our special equipment there so the pulse oximetry and blood pressure are on the lower extremities for cone beam again to avoid artifact and imaging when we first
started using cone beam the nursing staff administering sedation were disconnecting patients from monitoring so there were short interruptions with viewing vital signs it became risky and time-consuming to do
so during the procedure one set of EKGs triplicates are done just prior to tpz injection so the treat the EKG triplicates are basically they're two minutes apart in sets of three and lastly having to keep the tpz in a brown
bag and protected from light during the transfer nurse to position there's the photo on the left upper corner doctor busy day basically draws a tpz through a three-way stopcock under a sterile towel
while the nurse keeps the syringe in the brown bag poking a hole in the bag just to NIF to just enough to expose the tip of the syringe and attach it to the three-way this way the tpz is protected from light these reminder adjustments
however they were difficult from the standard and it took time for all the nurses and techs to adjust all right so this here is just a group photo Tom I've got Tyler on the right Thanh our technologist and ELISA and myself so I
thought this was a good photo to represent radiology many specialties consult two IR but it just isn't quite known yet by the general population and surprisingly by the medical staff as well there is a quote by dr. Rosa be
published quote the reason the public doesn't quite understand is we deal with so many disease entities and so many body parts it's hard to brand us unquote so I don't know if you guys were aware but interventional radiology is now its
own medical specialty so hepatocellular carcinoma is a primary malignancy of the liver and now the third leading cause of cancer deaths worldwide with over
I like to talk about brain infarc after Castro its of its year very symbolic a shoe and my name is first name is a shorter and probably you cannot remember my first name but probably you can remember my email address and join ovation very easy 40 years old man presenting with hematemesis and those coffee shows is aphasia verax and gastric barracks and how can i use arrow arrow on the monitor no point around yes so so you can see the red that red that just a beside the endoscopy image recent bleeding at the gastric barracks
so the breathing focus is gastric paddocks and that is a page you're very X and it is can shows it's a page of Eric's gastric barracks and chronic poor vein thrombosis with heaviness transformation of poor vein there is a spline or inertia but there is no gas drawer in urgent I'm sorry tough fast fast playing anyway bleeding focus is gastric barracks but in our hospital we don't have expert endoscopist
for endoscopy crew injections or endoscopic reinjection is not an option in our Hospital and I thought tips may be very very difficult because of chronic Peruvian thrombosis professors carucha tri-tips in this patient oh he is very busy and there is a no gas Torino Shanta so PRT o is not an option so we decided to do percutaneous there is your embolization under under I mean there are many ways to approach it
but under urgent settings you do what you can do best quickly oh no that's right yes and and this patience main program is not patent cameras transformation so percutaneous transit party approach may have some problem and we also do transit planning approach and this kind of patient has a splenomegaly and splenic pain is big enough to be punctured by ultrasonography and i'm a tips beginner so I don't like tips in this difficult
case so transplanting punch was performed by ultrasound guidance and you can see Carolus transformation of main pervane and splenorenal shunt and gastric varices left gastric we know officios Castries bezier varices micro catheter was advanced and in geography was performed you can see a Terrell ID the vascular structure so we commonly use glue from be brown company and amputee cyanoacrylate MBC is mixed with Italy
powder at a time I mixed 1 to 8 ratio so it's a very thin very thin below 11% igloo so after injection of a 1cc of glue mixture you can see some glue in the barracks but some glue in the promontory Audrey from Maneri embolism and angiography shows already draw barracks and you can also see a subtraction artifact white why did you want to be that distal
why did you go all the way up to do the glue instead of starting lower i usually in in these procedures i want to advance the microcatheter into the paddocks itself and there are multiple collateral channels so if i in inject glue at the proximal portion some channels can be occluded about some channels can be patent so complete embolization of verax cannot be achieved and so there are multiple paths first structures so multiple injection of glue is needed
anyway at this image you can see rigid your barracks and subtraction artifacting in the promenade already and probably renal artery or pyramid entry already so it means from one area but it demands is to Mogambo region patient began to complain of headache but american ir most american IRS care the patient but Korean IR care the procedure serve so we continue we kept the procedure what's a little headache right to keep you from completing your
procedure and I performed Lippitt eight below embolization again and again so I used 3 micro catheters final angel officio is a complete embolization of case repair ax patients kept complaining of headache so after the procedure we sent at a patient to the city room and CT scan shows multiple tiny high attenuated and others in the brain those are not calcification rapado so it means systemic um embolization Oh bleep I adore mixtures
of primitive brain in park and patient just started to complain of blindness one day after diffusion-weighted images shows multiple car brain in park so how come this happen unfortunately I didn't know that Porter from Manila penis anastomosis at the time one article said gastric barracks is a connectivity read from an airy being by a bronchial venous system and it's prevalence is up to 30 percent so normally blood flow blood in the barracks drains into the edge a
ghost vein or other systemic collateral veins and then drain into SVC right heart and promontory artery so from what embolism may have fun and but in most cases in there it seldom cause significant cranker problem but in this case barracks is a connectivity the promontory being fired a bronchial vein and then glue mixture can drain into the rapture heart so glue training to aorta and system already causing brain in fog or systemic embolism so let respectively
- So, I'm going to probably echo many of the themes that Gary just touched upon here. These are my disclosures. So, if we look at the CHEST guidelines on who should get pharmacomechanical techniques, it is very very very sobering, and I apologize if the previous speakers have shown this slide,
but essentially, what's right now being disseminated to the American College of CHEST Physicians is that nobody should get catheter-directed thrombolysis, the concept of pharmacomechanical technique should really only reserved as a last-ditch effort if nothing else works, if you happen to have somebody
with extraordinary expertise in your institution, it could not be more of a damning recommendation for what I'm about to talk to you about for the next eight or nine minutes or so. So, then the question is, what is the rationale? What are we talking about here?
And again, I'm going to say that Gary and I, I think are sort of kindred spirits in recognizing that we really do need to mature this concept of the catheter-based technique for pulmonary embolism. So, I'm going to put out a hypothetical question, what if there was a single session/single device therapy
for acute PE, Gary showed one, that could avoid high dose lytics, avoid an overnight infusion, acutely on the table lower the PA pressure, acutely improve the function of the right ventricle, rapidly remove, you know, by angiography,
thrombus and clot from the pulmonary artery, and it was extremely safe, what if we had that? Would that change practice? And I would respectfully say, yes it would. And then what if this concept has already been realized, and we're actually using this across the world
for STEMI, for stroke, for acute DVT, and so why not acute pulmonary embolism? What is limiting our ability to perform single session, rapid thrombus removal and
patient stabilization on the table? Gary showed this slide, there's this whole litany of different devices, and I would argue none of them is exactly perfect yet, but I'm going to try and sort of walk you through what has been developed in an attempt
to reach the concept of single session therapy. When we talk about pharmacomechanical thrombectomy or thrombo-aspiration, it really is just one line item on the menu of all the different things that we can offer patients that present with acutely symptomatic PE, but it is important to recognize
what the potential benefits of this technology are and, of course, what the limitations are. When we look at this in distinction to stroke or STEMI or certainly DVT, it's important to recognize that during a surgical pulmonary embolectomy case, the clot that's able to be extracted is quite impressive,
and this is a very very very sobering amount of material that is typically removed from the patient's right heart and their pulmonary circulation, so, in order to innovate and iterate a percutaneous technology based on existing concepts,
it really does demand significant disruption to achieve the goals, we have not tackled this yet in terms of our endovascular tool kit. So, what is the role? Well, it's potentially able to debulk in acute PE, in an intermediate risk patient which would
ideally eliminate the need for overnight lysis, as Gary alluded to, but what if it could actually replace surgical embolectomy in high risk patients? I think many of us have had the conversation where we, we sort of don't know that's there a
experienced, comfortable surgeon to do an embolectomy within the building or within immediate access to the patient that we see crashing in front of our eyes. I'm very very lucky here in New York that I've incredible cardiovascular surgeons that are able to perform this procedure very very safely 24/7,
but I know that's not the case across the country. So, one of our surgeons who actually came from the Brigham and Women's Hospital in Boston developed this concept, which was the sort of first bridge between surgical embolectomy and percutaneous therapy, which is a large bore aspiration catheter,
it's a 22 French cannula that was originally designed to be placed through a cutdown but can now be placed percutaneously, and I think many of us in the room are familiar with this technology, but essentially you advance this under fluoroscopy into the right heart,
place the patient on venous-venous bypass, and a trap, which is outside the patient, is demonstrated in the lower left portion of the screen here, is able to capture any thrombotic material and then restore the circulation via the contralateral femoral vein,
any blood that is aspirated. Very very scant data on this, here's the experience from Michael and Kenny up in Boston where they tried this technology in just a handful of cases, this was followed by John Moriarty's experience from UCLA, where he actually argued a little bit of caution
using this technology, largely related to its inability to safely and reliably deliver it to the pulmonary circulation. To that end, AngieDynamics is funding a prospective registry really looking at safety and efficacy at delivering this device to the pulmonary circulation
and its ability to treat acute pulmonary embolism as well as any right heart clot, but that data's not commercially available yet. This is just one case that we did recently of a clot in transit, which I would argue could not be treated with any other technology
and the patient was able to be discharged the same day, I personally think this is a wonderful application of this technology and is our default strategy right now for a very large clot in transit. The second entrance to the space is the Inari FlowTriever device, which is a 20 French cannula,
it does not require a perfusion team in vein-vein bypass, the concept is simple, a 20 French guide catheter is advanced into the pulmonary circulation and these trilobed disks, which function like a stentriever for stroke are deployed in the pulmonary circulation, retracted to allow the clot to be delivered to the guide cath,
and then using manual aspiration, the clot is retrieved from the patient. Just a few case reports in small series describing this, this one in JACC two years ago, showing quite robust ability to extract a clot, this company which is a relatively small company funded a
single-arm prospective trial enrolling 168 patients, and not only did they complete enrollment last year, but they actually received FDA approval, now there is no peer-reviewed literature on this, it has undergone public presentation, but we, we really don't know exactly which patients were treated,
and so we really can't dissect this, I think there is a learning curve to this technology, and it's not, certainly, ready for broad dissemination yet, we just don't know which patients are ideal for it currently. Another technology, the Penumbra CAT8 system,
a market reduction in the size, an 8 French catheter based technology, this is exact same technology that's used for thrombo-aspiration for acute ischemic stroke, currently just in a slightly different size, and then a number of cases demonstrating its efficacy at
alleviating the acute nonperfusion of an entire lobe, as Gary was referring to previously, and this is one of our cases from our own lab, where you see there's no perfusion of the right, middle and lower lobe, I'm not sure if I can get these movies to play here, oh here it goes,
and so using sort of a handmade separator, we were able to restore perfusion again to the right, middle and lower lobe here, so just one example where, I think there is a potential benefit of thrombo-aspiration in a completely occluded segment.
There has been a wealth of literature about this technology, mostly demonstrating safety and efficacy, the most recent one on the bottom right in CVIR demonstrates the ability to acutely reduce the PA pressures on the table with the use of this technology, and to that end,
Akhi Sista, our faculty here this morning, is the national principal investigator of a US multicenter prospective study looking at exactly that, to try and prove that this technology is safe and effective in the treatment of submassive pulmonary embolism, so more to come on that.
Lastly, the AngioJet System, probably the most reported and studied technology, this is a 6 French technology by default, a wealth of literature here showing safety and efficacy, however, due to adverse event reporting, this technology currently has black box label warnings
in the treatment of acute pulmonary embolism, so clearly this technology should not be used by the novice, and there are significant safety concerns largely related to bradyarrhythmias and hypotension, that being said, again, it is a quite experienced technology for this. So where do we currently stand?
I think we clearly see there are several attributes for thrombo-aspiration including just suction aspiration, a mechanical stent-triever technology, and the ability to not just insanguinate the patient but actually restore circulation and not make the patient anemic, here,
you can see where these technologies are going in terms of very very large bore and very small bore, I placed the question marked right in the center which is where I think this technology needs to converge in order to lead to the disruption for the broad adoption of a single session technology.
So, numerous devices exist, all the devices have been used clinically and have demonstrated the ability to be delivered in aspirary pulmonary embolus, at present, unfortunately there is no consensus regarding which device should be used for which patients and in which clinical presentations,
we need many prospective studies to demonstrate the safety and clinical benefit for our patients, we desperately do need a single session therapy, again, I completely agree with Gary on this, but there is a lot of work yet to do. Thank you for your attention.
- This is from some work in collaboration with my good friend, Mike Dake. And, a couple of years of experience at Stanford now. First described by Kazy? years ago. This technical note of using multiple main-body endographs in a sandwich formation.
Up at the top but, then yielding multiple branches to get out to the visceral vessels and leaving one branch for a bifurcated graft. We've sort of modified it a little bit and generally either use multiple
grafts in order to create a branch the celiac and SMA. Left the celiac sometimes for a chimney, but the strategy really has been in one of the limbs to share both renals and the limb that goes down to the legs. We noticed early on that this really was not for
non-operative candidates, only for urgent cases and we recognize that the visceral branches were the most important to be in their own limb. I'll just walk you through a case. 6.8 centimeter stent for foraco above
the prior opened repair. The plan drawn out here with multiple main bodies and a second main body inside in order to create the multiple branches. The first piece goes in. It's balloon molded at the level of pulmonary
vein with enough length so that the ipsalateral limb is right next to the celiac. And we then, from above get into that limb and down into the celiac vessel and extend with either a limb or a viabahn. Next, we deploy a second main body inside
of the gate, thus creating now another two limbs to work through. And then through that, extend in its own branch a limb to the SMA. This was an eight by 79 vbx. Then we've got a third limb to go through.
We put a cuff that measures about 14. This is the math so that the double renal snorkle plus the main body fills up this hole. Now, double sheath access from above, looking for both renals. Sheaths out into both renals with viabahns
inside of that. Deployment of the bottom device and then a final angiogram with a little bit of a gutter that we often see when we have any kind of parallel graft configuration. Here's the post-op CT scan wherein
that limb is the two shared renals with the leg. This is the one year post-op with no endo leaks, successful exclusion of this. Here's another example of one of an eight and a half centimeter stent three thorico similar strategy, already with an occluded
celiac. Makes it a little bit easier. One limb goes down to the superior mesenteric artery and then the other limb then is shared again bilateral renals in the lower main body. Notice in this configuration you can get all the way up to the top then by putting a thoracic component
inside of the bifurcated subabdominal component. There's the final CT scan for that. We've spent some time looking at the different combinations of how these things will fill up to minimize the gutters through some more work. In collaboration with some friends in Kampala.
So we've treated 21 patients over the last couple of years. 73 years of age, 48 percent female usual comorbid factors. Oh, I thought I had more data there to show you. O.K. I thought this was a four minute talk.
Look at that. I'm on time. Octopus endovascular strategy is a feasible off the shelf solution for high risk patients that can't undergo open repair. You know obviously, sort of in this forum and coming to this meeting we see what's
available outside of the U.S. and I certainly am awaiting clinical trial devices that will have purpose specific teacher bi-graphs. The end hospital morbidity has still been high, at four percent. The one year survival of 71 percent in this select
group of 21 patients is acceptable. Paraplegia is still an issue even when we stage them and in this strategy you can stage them by just doing the top part plus the viscerals first and leaving the renals for another day. And branch patency thus far has been
in the short term similar to the purpose specific graft as well as with the parallel graft data. Thank you.
my last case here you have a 54 year old patient recent case who had head and neck cancer who presents with severe bleeding from a tracheostomy alright for some bizarre reason we had two of these
in like a week all right kind of crazy so here's the CT scan you can see the asymmetry of the soft tissue this is a patient who had had a neck cancer was irradiated and hopefully what you can notice on the
right side of the screen is the the large white circles of contrast which really don't belong there they were considered to be pseudo aneurysms arising from the carotid artery all right that's evidence of a bleed he was
bleeding out of his tracheostomy site so here's a CTA I think the better image is the image on the right side of the screen the sagittal image and you can see the carotid artery coming up from the bottom and you can see that round
circle coming off of the carotid artery you guys see that so here's the angiogram all that stuff that is to the right to the you know kind of posterior to the right of the screen there it doesn't belong there that's just
contrast that's exiting the carotid artery this is a carotid blowout we'll call it okay just that word sounds bad all right so that's bad so another question right what do you want to do here
I think embolization is reasonable but probably not the thing we can do the fastest to present a patient to treat a patient is bleeding out of the tracheostomy site so in this particular case this is a great covered stent case
alright and here's what it looked like after so we can go right up and just literally a cover sent right across the origin of that pseudoaneurysm and address the patient's bleeding alright
medicine so very innovative though I will tell you necessity is the mother of all inventions right so if I can't get a hold of these products that I'm reading
about they they come up with some of their own products and some of their own procedures that were very innovative specially in the the world of IO SCI lastik intrahepatic biliary stands are very common over there they were
actually innovated over in China of radionuclide impregnated pillory stents imagine taking y9t shoving them in billary stents and putting them in to treat biliary cancer in atresia they do that quite readily over there we don't
do that here in the US but we're experimenting with it intravascular catheter directed gene therapy actually started in China pre portal vein thrombus to me for transplant liver functionality they do
that very commonly we just consider a very complex procedure over here catheter directed stem cell treatment for focal after mattis lesions they do that instead of doing stents over there and they're all innovated in China so as
I said necessity is the mother all of invention and when you go overseas and you get to work with some of your interventional colleagues who do not have access to what we currently have here in the Western medicine world
you'll be amazed at some of the stuff they've come up with it try to treat their patients so from American
these are the difficulties that I find
in provision of care and when I talk to some Mike in China they definitely commiserate in this what they were telling me that they feel are some of the issues they have you know simonin limits access to
international based medical products it's it's coming up with protectionism they want their products utilized well unfortunately there is a perception that some of these products that were made originally in China and probably not so
much nowadays been in the past we're not exactly up to the same type of you know Quality Assurance levels as US based or European products and that made it very difficult you know guys would go and they would learn in in the Western
world they'd be doing all these different studies and research reading what we're doing over here and then they wouldn't have access to the products or the procedures to take care of their patients the second thing
it's kind of difficult is CFDA which is Chinese version of the FDA they very much limit access and is very hard to get a product from overseas from Europe or to us into China they require in China in-country clinical studies they
require multiple products to actually evaluate so if you want to send us a where we're merit since I have some of my colleagues from Mary here and you wanted to send a product to get evaluated in China they can hold on to
and take up to three years for evaluation they'll last for about 4 000 units to evaluate and then they reverse-engineer them send them back to you and deny your Chinese your CFDA application their masters reverse
engineering so medical device companies are very hesitant sometimes to send their IP products over because international patents are not really covered in Chinese law so they can't knock these products off and and I think
the hardest thing is that patients are required to pay for products that are not made in country so when you're doing intervention I came across this when I was doing intervention and I was very blessed to be able to get credentials
and do intervention over there I would be doing a mather in her case and we had been ovo stents up which I've just got the you know approval here in the US by the FDA two weeks ago they've been using him there for almost two years but the
problem that we had with that is that the patient would have had to pay for them so I'm doing intervention and Manor you have to stent mather no you cannot just balloon it it's not effective and you'll have residual restenosis I had to
stop the procedure get the patients family and explain what was going on and offer them the stent and if they couldn't pay it we got him off the table and we were done and they ended up there I'm bussing their leg off again and
unfortunately that happened you know on one of my patients in his very fresh string is a Western provider clinician who's used to having the ability to do those things you just can't so it's it was definitely a frustrating thing for
me and certainly frustrating for the Chinese physicians and interventional study are there that know what they need to do but don't have access to the products readily or can't make their patients pay for these things because
they can't afford them and also it's kind of coming from a u.s. perspective we're used to single use of products over there there's no such thing as a you know one use disposable they will restore lies things that were not made
to be rese terrorized and as a Western clinician coming over there that's totally against everything we've ever thought about but you just kind of accept that practice and realize it's what's gonna happen so it's it's kind of
interesting I've saw you know IVC filters that were sterilized and we use after being in patients they do what they got to do and so these interesting those are some of the things you need to remember think about considerations
that's different than your ideologies that you were trained in in Western
- Thanks (mumbles) I have no disclosures. So when were talking about treating thoracoabdominal aortic aneurysms in patients with chronic aortic dissections, these are some of the most difficult patients to treat. I thought it would be interesting
to just show you a case that we did. This is a patient, you can see the CT scrolling through, Type B dissection starts pretty much at the left subclavian, aneurysmal. It's extensive dissection that involves the thoracic aorta, abdominal aorta,
basically goes down to the iliac arteries. You can see the celiac, SMA, renals at least partially coming off the true and continues all the way down. It's just an M2S reconstruction. You can see again the extent of this disease and what makes this so difficult in that it extends
from the entire aorta, up proximally and distally. So what we do for this patient, we did a left carotid subclavian bypass, a left external to internal iliac artery bypass. We use a bunch of thoracic stent grafts and extended that distally.
You can see we tapered down more distally. We used an EVAR device to come from below. And then a bunch of parallel grafts to perfuse our renals and SMA. I think a couple take-home messages from this is that clearly you want to preserve the branches
up in the arch. The internal iliac arteries are, I think, very critical for perfusing the spinal cord, especially when you are going to cover this much. And when you are dealing with these dissections, you have to realize that the true lumens
can become quite small and sometimes you have to accommodate for that by using smaller thoracic endografts. So this is just what it looks like in completion. You can see how much metal we have in here. It's a full metal jacket of the aorta, oops.
We, uh, it's not advancing. Oops, is it 'cause I'm pressing in it or? All right, here we go. And then two years post-op, two years post-op, you can see what this looks like. The false lumen is completely thrombosed and excluded.
You can see the parallel grafts are all open. The aneurysm sac is regressing and this patient was successfully treated. So what are some of the tips and tricks of doing these types of procedures. Well we like to come in from the axillary artery.
We don't perform any conduits. We just stick the axillary artery separately in an offset manner and place purse-string sutures. You have to be weary of manipulating around the aortic arch, especially if its a more difficult arch, as well as any thoracic aortic tortuosity.
Cannulating of vessels, SMA is usually pretty easy, as you heard earlier. The renals and celiac can be more difficult, depending upon the angles, how they come off, and the projection. You want to make sure you maintain a stiff wire,
when you do get into these vessels. Using a Coda balloon can be helpful, as sometimes when you're coming from above, the wires and catheters will want to reflux into that infrarenal aorta. And the Coda balloon can help bounce that up.
What we do in situations where the Coda doesn't work is we will come in from below and a place a small balloon in the distal renal artery to pin the catheters, wires and then be able to get the stents in subsequently. In terms of the celiac artery,
if you're going to stent it, you want to make sure, your wire is in the common hepatic artery, so you don't exclude that by accident. I find that it is just simpler to cover, if the collaterals are intact. If there is a patent GDA on CT scan,
we will almost always cover it. You can see here that robust collateral pathway through the GDA. One thing to be aware of is that you are going to, if you're not going to revascularize the celiac artery you may need to embolize it.
If its, if the endograft is not going to oppose the origin of the celiac artery in the aorta because its aneurysmal in that segment. In terms of the snorkel extent, you want to make sure, you get enough distal purchase. This is a patient intra-procedurally.
We didn't get far enough and it pulled out and you can see we're perfusing the sac. It's critical that the snorkel or parallel grafts extend above the most proximal extent of your aortic endograft or going to go down. And so we take a lot of care looking at high resolution
pictures to make sure that our snorkel and parallel grafts are above the aortic endograft. This is just a patient just about a year or two out. You can see that the SMA stent is pulling out into the sac. She developed a endoleak from the SMA,
so we had to come in and re-extend it more distally. Just some other things I mentioned a little earlier, you want to consider true lumen space preserve the internals, and then need to sandwich technique to shorten the parallel grafts. Looking at a little bit of literature,
you can see this is the PERCLES Registry. There is a number of type four thoracos that are performed here with good results. This is a paper looking at parallel grafting and 31 thoracoabdominal repairs. And you can see freedom from endoleaks,
chimney graft patency, as well as survival is excellent. This was one looking purely at thoracoabdominal aneurysm repairs. There are 32 altogether and the success rates and results were good as well. And this was one looking at ruptures,
where they found that there was a mean 20% sac shrinkage rate and all endografts remained patent. So conclusion I think that these are quite difficult to do, but with good techniques, they can be done successfully. Thank you.
- Thank you very much, Gustavo, you read the abstract so now my task is to convince you that this very counter-intuitive technique actually works, you are familiar with Petticoat, cover stent to close a proximal entry tear and then uncover stents, bear stents, downstream. This what it would look like when we open up
the bare stent, you know dissect the aorta. So here's a case example, acute type B with malperfusion, the true lumen is sickle shaped, virtually occluded. So we use Petticoat, and we end up with a nice reopening of the true lumen, it is tagged here in green, however if you look more closely you see that here
wrapping around the true lumen there is a perfused false lumen. This is not an exception, not a complication, this is what happens in most cases, because there are always reentries in the celiac portion of the aorta.
So the Stablise concept was introduced by Australian group of Nixon, Peter Mossop in 2012, after you do the Petticoat, you are going to voluntarily balloon inside both the stent graft and the bare stents in order to disrupt, to fracture the lamel, obtain a single-channeled aorta.
This is what it looks like at TEE, after deployment of the stent graft, you see the stent graft does not open up completely, there is still some false lumen here, but after the ballooning, it is completely open. So the results were immediately very, very good, however technique did not gain a lot of consensus,
mainly because people were afraid of rupturing the aorta, they dissect the aorta. So here's a Stabilise case, once again, acute setting, malperfusion, we do a carotid subclavian bypass because we are going to cover the subclavian artery, we deploy
the cover stent graft, then with one stent overlap, we deploy two bare stent devices all the way down to the iliacs and then we start ballooning from the second stent down, so you see Coda balloon is used here, but only inside the cover stent with fabric.
And then more distally we are using a valvuloplastic balloon, which is noncompliant, and decides to be not larger than the aorta. So, I need probably to go here, this is the final result, you can see from the cross-sections that the dissection is completely gone and
the aorta is practically healed. So you might need also to address reentries at the iliac levels, attention if you have vessels that only come from the false lumen, we want to protect them during the ballooning, so we have a sheath inside this target vessel, and we are
going to use a stent afterwards to avoid fragments of the intima to get into the ostium of the artery. And this is a one-year control, so as you can see there is a complete remodeling of the aorta, the aorta is no longer dissected, it's a single channel vessel, here we can see stents in two vessels that came
from the false lumen, so very satisfactory. Once again, please remember, we use compliant latex balloons only inside the the cover stent graft, and in the bare stents we use non-compliant balloons. We have published our first cases, you can find more details in the journal paper, so in conclusion,
dear colleagues, Stabilise does work, however we do need to collect high-quality data and the international registry is the way to do this, we have the Stabilise registry which is approved by our ethical committee, we have this group of initial friends that are participating,
however this registry is physician initiated, it's on a voluntary base, it is not supported by industry, so we need all the possible help in order to get patients as quickly as possible, please join, just contact us at this email, we'd be more than happy to include everybody who is
doing this technique according to this protocol, in order to have hard data as soon as possible, thank you very much for your attention.
- Thank you for introduction. Thanks to Frank Veith for the kind invitation to present here our really primarily single-center experience on this new technique. This is my disclosure. So what you really want
in the thromboembolic acute events is a quick flow restoration, avoid lytic therapies, and reduce the risk of bleeding. And this can be achieved by surgery. However, causal directed local thrombolysis
is much less invasive and also give us a panoramic view and topographic view that is very useful in these cases. But it takes time and is statistically implied
and increases risk of bleeding. So theoretically percutaneous thrombectomy can accomplish all these tasks including a shorter hospital stay. So among the percutaneous thrombectomy devices the Indigo System is based on a really simple
aspiration mechanism and it has shown high success in ischemic stroke. This is one of my first cases with the Indigo System using a 5 MAX needle intervention
adapted to this condition. And it's very easy to understand how is fast and effective this approach to treat intraprocedural distal embolization avoiding potential dramatic clinical consequences, especially in cases like this,
the only one foot vessel. This is also confirmed by this technical note published in 2015 from an Italian group. More recently, other papers came up. This, for example, tell us that
there has been 85% below-the-knee primary endpoint achievement and 54% in above-the-knee lesions. The TIMI score after VAT significantly higher for BTK lesions and for ATK lesions
a necessity of a concomitant endovascular therapy. And James Benenati has already told us the results of the PRISM trials. Looking into our case data very quickly and very superficially we can summarize that we had 78% full revascularization.
In 42% of cases, we did not perform any lytic therapy or very short lytic therapy within three hours. And in 36% a long lytic therapy was necessary, however within 24 hours. We had also 22% failure
with three surgery necessary and one amputation. I must say that among this group of patients, twenty patients, there were also patients like this with extended thrombosis from the groin to the ankle
and through an antegrade approach, that I strongly recommend whenever possible, we were able to lower the aspiration of the clots also in the vessel, in the tibial vessels, leaving only this region, thrombosis
needed for additional three hour infusion of TPA achieving at the end a beautiful result and the patient was discharged a day after. However not every case had similar brilliant result. This patient went to surgery and he went eventually to amputation.
Why this? And why VAT perform better in BTK than in ATK? Just hypotheses. For ATK we can have unknown underlying chronic pathology. And the mismatch between the vessel and the catheter can be a problem.
In BTK, the thrombus is usually soft and short because it is an acute iatrogenic event. Most importantly is the thrombotic load. If it is light, no short, no lytic or short lytic therapy is necessary. Say if heavy, a longer lytic therapy and a failure,
regardless of the location of the thrombosis, must be expected. So moving to the other topic, venous occlusive thrombosis. This is a paper from a German group. The most exciting, a high success rate
without any adjunctive therapy and nine vessels half of them prosthetic branch. The only caution is about the excessive blood loss as a main potential complication to be checked during and after the procedure. This is a case at my cath lab.
An acute aortic renal thrombosis after a open repair. We were able to find the proximate thrombosis in this flush occlusion to aspirate close to fix the distal stenosis
and the distal stenosis here and to obtain two-thirds of the kidney parenchyma on both sides. And this is another patient presenting with acute mesenteric ischemia from vein thrombosis.
This device can be used also transsympatically. We were able to aspirate thrombi but after initial improvement, the patient condition worsened overnight. And the CT scan showed us a re-thrombosis of the vein. Probably we need to learn more
in the management of these patients especially under the pharmacology point of view. And this is a rapid overview on our out-of-lower-limb case series. We had good results in reimplanted renal artery, renal artery, and the pulmonary artery as well.
But poor results in brachial artery, fistula, and superior mesenteric vein. So in conclusion, this technology is an option for quick thromboembolic treatment. It's very effective for BTK intraprocedural embolic events.
The main advantage is a speeding up the blood flow and reestablishing without prolonged thrombolysis or reducing the dosage of the thrombolysis. Completely cleaning up extensive thromobosed vessels is impossible without local lytic therapies. This must be said very clearly.
Indigo technology is promising and effective for treatment of acute renovisceral artery occlusion and sub massive pulmonary embolism. Thank you for your attention. I apologize for not being able to stay for the discussion
because I have a flight in a few hours. Thank you very much.
- Thank you, it's a pleasure to be here. I'll address how the Indigo Thrombectomy technology can expand the reach of what you can do for your patients. It will preserve treatment options, improve patient outcomes, conserve hospital resources,
and perhaps most importantly, improve your day. The old treatment strategy, every time I had someone with acute limb ischemia I felt like I was shopping at this store. When I went to surgery, I wished I could put a drip catheter in, it lasts a little longer,
to mop up some di when I went to the angio suite, I wished I could cut down and remove some more macroscopic debris. I submit that the new Indigo technology
will provide a new strategy for treating acute arterial ischemia. On the same concepts are predicated STEMI, code stroke, Level I trauma alerts, we've instituted acute aorta, and piggybacked on that, an acute arterial ischemia protocol.
So that means when a patient like this presents with acute arterial ischemia, they get an algorithmic, systemic, trained, metered approach. They go past the holding room directly to the endovascular suite,
and all the processes happen in parallel, not in series. The call team is trained and dedicated, and while anesthesia is working up top with labs and lines, we use the duplex ultrasound to pick carefully our access sites. A faster time to reperfusion allows us to
do it and avoid general anesthesia, incision in hostile groins, and the exposure of lytic therapy, resulting in a decreased morbidity and mortality. Being able to treat the full spectrum of the arterial tree allows us to run options.
We preserve options by first mopping up more proximal clot, and then dripping distally when we need to, or, dripping distally to open up distal targets for surgical bypasses. As an example, this was a recent case
on a trauma CT scan, injured inthrelane aorta with emblogenic thrombus confirmed on intravascular ultrasound. We went in with a large bore system, a cath to aspirate the clot, and then used a cover stent to repair the aorta.
We shot an arteriogram the lower extremities, noticed that it embolized distally, and we used a Cat 6 to pluck out this clot and restore flow. Able to work up and down the full arterial tree. A learning curve for me was to understand that debris has to be corked to removal, which means no flow.
And most other worlds in vascular surgery, flow is good. No flow is bad. Also, you have to vacuum the clot out. Which means you have to uncross the lesion, which is counter intuitive for most of the precepts I've learned.
I've learned to use long sheaths to approach the lesion and to use larger catheters to remove more macroscopic debris. I rarely use the separator, I engage it and cork it for 90 seconds. That allows it to get a firm grip and purchase on it.
And I have to remember that no flow is good. This demonstrates how you approach the catheter with a large sheath. Under roadmap guidance you turn the aspiration vacuum on immediately before you cork it to minimize blood loss. And you use it like a vacuum by uncrossing the lesion
and let it slowly engage and aspirate the catheter. Ninety seconds allows it to get a firm grip and purchase so you can extract it without breaking it loose. I rarely use a separator, I use it only for large thrombus burdens, sub-acute clot, adherent debris,
or when the Indigo catheter is clogged. I strip out the catheter with the separator like a pipe cleaner, and then, every once in a while, on a subacute clot, I'll peck and morcellate it with a separator. Typically, in my lab, when I have new technology
I never have the team trained when I have just the right case, so I've learned over time, to train the team first. And with a trained team, they've taught me a lot. I've found with the Indigo catheter it's hard for me to watch the monitor,
work the catheter, handle the on-off switch, and watch the flow in the canister. So, what we do is we have a spotter who's not scrubbed. They taught me to take the on-off switch out, and then mechanically kink the tubing to make and on-off switch.
And they provide me feedback and just say fast, slow, or corked, so I can run the catheter and watch the monitor. I've learned to beware of the Cook Flexor sheaths, because they scuff up the tip. Use a check flow valve that unscrews from the
catheter if possible. I use coaxial catheters whenever possible, and I telescope them. You can telescope large catheters over small catheters. I use large sheaths and catheters whenever possible, using the preclose technique,
and then you can preserve options if you want to press more distally, you can cinch down, remove the large sheath, put in a 4 5 French, and then press ahead. I also, after I use a pulse technique, will occasionally use the Jungle Juice.
The team taught me the Jungle Juice is half strength contrast, some TPA and some nitroglycerine. When I lace the clot with Jungle Juice, I can observe fluoroscopically, the progress I'm making as I'm aspirating the clot. Thank you.
patient female patient who has the sudden onset of upper abdominal pain here's the CT we did all these cases in one day it was crazy it was terrible so so here's a big hematoma a big peritoneal hematoma you
can see it anterior to the right kidney you can see the white blob of contrast right in the middle of the hematoma that's a pseudoaneurysm or even active extravagance um less experienced people would probably say it's active
extravagant I think most of us would prefer that it be called kind of a pseudoaneurysm this active extrapolation would be much more cloudy and spread out this is more constrained and you can see on the
coronal image you get a sense that there's that hematoma same type of problem all right is there more imaging that we can do to figure out the next step again I said earlier earlier in this lecture
that sometimes we use CTA now sometimes a CTA is worthwhile I do find that for a lot of these patients I think we're getting smarter and we're doing CTAs right at the beginning of this whole thing you know when a trauma
patient comes in we're getting CTAs so we can max out the amount of information that we get on the initial diagnostic imaging here's what we're seeing on the CTA and in this particular case I think it's pretty clear that you can see the
pseudoaneurysm arising from what looks like a branch of the superior mesenteric artery so this is just an odd visceral and Jake visceral aneurysm which looks like it probably ruptured I don't have an explanation for it led to a big
hematoma here's what that is and now we're gonna do an angiogram the neat thing is it just perfectly correlated with a conventional angiogram so here's our super mesenteric angiogram all right the supreme mesenteric artery
on the first image to the left is that vessel going downward towards the right side of the screen all those vessels coming off are really just collateral vessels going up to the liver through the gastroduodenal artery again that
left one looks pretty good it's not until you see the delayed image on the right that you see that area of contrast all right so that's the finding that correlates with the CT scan all right here we're able to get in there you put
a micro catheter in that vessel alright the key next step for this patient as I mentioned earlier is the whole concept of front door and back door so here we're technically in the front door the next thing that we do is we put the
catheter past the area of injury and now we embolize right across the injury because remember once you embolize one thing flow is gonna change we screw it up body the body wants to preserve its flow if we block flow
somewhere the body's gonna reroute blood to get to where we blocked it so we want to think ahead and we want to say okay we're blocking this vessel how's the body going to react and let's let's get in the way of that happening that's what
we did here so we saw the pathology we went past it we embolized all across the pathology and boom now we don't have anymore bleeding and the likelihood of recurrence is gonna be very low for that patient because we went all the way
across the abnormality and I think from
- Thank you. Thank you again for the invitation, and also my talk concerns the use of new Terumo Aortic stent graft for the arch. And it's the experience of three different countries in Europe. There's no disclosure for this topic.
Just to remind what we have seen, that there is some complication after surgery, with mortality and the stroke rate relatively high. So we try to find some solution. We have seen that we have different options, it could be debranching, but also
we know that there are some complications with this technique, with the type A aortic dissection by retrograde way. And also there's a way popular now, frozen elephant trunk. And you can see on the slide the principle.
But all the patients are not fit for this type of surgery. So different techniques have been developed for endovascular options. And we have seen before the principle of Terumo arch branch endograft.
One of the main advantages is a large window to put the branches in the different carotid and brachiocephalic trunk. And one of the benefit is small, so off-the-shelf technique, with one size for the branch and different size
for the different carotids. This is a more recent experience, it's concerning 15 patients. And you can see the right column that it is. All the patients was considered unfit for conventional surgery.
If we look about more into these for indication, we can see four cases was for zone one, seven cases for zone two, and also four cases for zone three. You can see that the diameter of the ascending aorta, the min is 38,
and for the innominate artery was 15, and then for left carotid was eight. This is one example of what we can obtain with this type of handling of the arch with a complete exclusion of the lesion, and we exclude the left sonography by plyf.
This is another, more complex lesion. It's actually a dissection and the placement of a stent graft in this area. So what are the outcomes of patients? We don't have mortality, one case of hospital mortality.
We don't have any, sorry, we have one stroke, and we can see the different deaths during the follow-up. If we look about the endoleaks, we have one case of type three endoleak started by endovascular technique,
and we have late endoleaks with type one endoleaks. In this situation, it could be very difficult to treat the patient. This is the example of what we can observe at six months with no endoleak and with complete exclusion of the lesion.
But we have seen at one year with some proximal type one endoleak. In this situation, it could be very difficult to exclude this lesion. We cannot propose this for this patient for conventional surgery, so we tried
to find some option. First of all, we tried to fix the other prosthesis to the aortic wall by adjusted technique with a screw, and we can see the fixation of the graft. And later, we go through the,
an arrangement inside the sac, and we put a lot of colors inside so we can see the final results with complete exclusion. So to conclude, I think that this technique is very useful and we can have good success with this option, and there's a very low
rate of disabling stroke and endoleaks. But, of course, we need more information, more data. Thank you very much for your attention.
good morning everybody's how's everybody doing today so I'm three coffees in you're gonna have to hold on for the ride it's gonna get pretty quick but what I am gonna do is gonna be talking a little bit today about the interventional market in China
specifically you know one of the things that I'm very blessed to do with my role that's of global roles I travel all over the place and dealing with colleagues and people overseas getting an understanding of how we do intervention
some places doing intervention overseas so I get a different perspective in China's a very unique market to do intervention for the interventionist for the patients and certainly for companies that are trying to come in to China from
the United States Great Britain overseas it's a different market something totally different than what we're used to here in the US now has anybody here ever traveled to China any hands well Christian put your hand down I know you
did excellent well I was gonna say if the room was full of people that traveled the China's gonna drop the mic and walk out get another cup of coffee but what we're gonna talk about a little bit is kind of my perspective on things
and I will tell you I'm a little non-traditional and how I do things just these right here in my my disclosures and like I said I do like long walks on the beach fluffy clouds cotton candy and I really do wish I
could grow a mustache like Jim kratie you guys like that mustache right pretty fantastic it's like Wyatt Earp come on you'll love that so let's talk about trying a little
something some case examples of where I use cryoablation right so this is a
patient who has a nodule in the in the back of their lungs in the right lower lobe and basically I'll place two probes into that notch on either side of Brackett the lesion and then three months later fall up you can see a nice
resolution of that nodule so when it comes to lung a couple things I'll mention is if the nodule is greater than eight millimeters I'll immediately go to two probes I want to make sure that I cover the lesion whereas microwave it's
pretty rare depending on what device you're using for you to put more than one probe in so some people's concern with cryo in the lung is more probes means more risk of pneumothorax but you can also see surrounding and proximal to
where we did the place you can see the hemorrhage that you see so if those of you out there that are doing the lung ablations you probably have physicians that are using something called the triple freeze protocol right so the
double freeze protocol is the idea that you go ten minutes freeze five minutes 30 minutes freeze five minutes thought well what we saw was lung early on in the studies was a very large ablation a freeze to start with caused massive
hemorrhage patients were having very large amounts of hemorrhage so what we do now in lung is something called a triple freeze protocol we'll do a very short freeze about three minutes and that'll cause an ice ball to form and
then we'll thaw that in other three minutes three minutes of thawr and as soon as that starts to thaw we'll freeze it again and we've shown us a substantial decrease in the amount of hemorrhage so if you're doing long and
you and you you're told to do a double freeze protocol perhaps suggest the triple freeze is a better idea so that's three months later so another example
- The only disclosure is the device I'm about to talk to you about this morning, is investigation in the United States. What we can say about Arch Branch Technology is it is not novel or particularly new. Hundreds of these procedures have been performed worldwide, most of the experiences have been dominated by a cook device
and the Terumo-Aortic formerly known as Bolton Medical devices. There is mattering of other experience through Medtronic and Gore devices. As of July of 2018 over 340 device implants have been performed,
and this series has been dominated by the dual branch device but actually three branch constructions have been performed in 25 cases. For the Terumo-Aortic Arch Branch device the experience is slightly less but still significant over 160 device implants have been performed as of November of this year.
A small number of single branch and large majority of 150 cases of the double branch repairs and only two cases of the three branch repairs both of them, I will discuss today and I performed. The Aortic 3-branch Arch Devices is based on the relay MBS platform with two antegrade branches and
a third retrograde branch which is not illustrated here, pointing downwards towards descending thoracic Aorta. The first case is a 59 year old intensivist who presented to me in 2009 with uncomplicated type B aortic dissection. This was being medically managed until 2014 when he sustained a second dissection at this time.
An acute ruptured type A dissection and sustaining emergent repair with an ascending graft. Serial imaging shortly thereafter demonstrated a very rapid growth of the Distal arch to 5.7 cm. This is side by side comparison of the pre type A dissection and the post type A repair dissection.
What you can see is the enlargement of the distal arch and especially the complex septal anatomy that has transformed as initial type B dissection after the type A repair. So, under FDA Compassion Use provision, as well as other other regulatory conditions
that had to be met. A Terumo or formerly Bolton, Aortic 3-branch Arch Branch device was constructed and in December 2014 this was performed. As you can see in this illustration, the two antegrade branches and a third branch
pointing this way for the for the left subclavian artery. And this is the images, the pre-deployment, post-deployment, and the three branches being inserted. At the one month follow up you can see the three arch branches widely patent and complete thrombosis of the
proximal dissection. Approximately a year later he presented with some symptoms of mild claudication and significant left and right arm gradient. What we noted on the CT Angiogram was there was a kink in the participially
supported segment of the mid portion of this 3-branch graft. There was also progressive enlargement of the distal thoracoabdominal segment. Our plan was to perform the, to repair the proximal segment with a custom made cuff as well as repair the thoracoabdominal segment
with this cook CMD thoracoabdominal device. As a 4 year follow up he's working full time. He's arm pressures are symmetric. Serum creatinine is normal. Complete false lumen thrombosis. All arch branches patent.
The second case I'll go over really quickly. 68 year old man, again with acute type A dissection. 6.1 cm aortic arch. Initial plan was a left carotid-subclavian bypass with a TEVAR using a chimney technique. We changed that plan to employ a 3-branch branch repair.
Can you advance this? And you can see this photo. In this particular case because the pre-operative left carotid-subclavian bypass and the extension of the dissection in to the innominate artery we elected to...
utilize the two antegrade branches for the bi-lateral carotid branches and actually utilize the downgoing branch through the- for the right subclavian artery for later access to the thoracoabdominal aorta. On post op day one once again he presented with
an affective co arctation secondary to a kink within the previous surgical graft, sustaining a secondary intervention and a placement of a balloon expandable stent. Current status. On Unfortunately the result is not as fortunate
as the first case. In 15 months he presented with recurrent fevers, multi-focal CVAs from septic emboli. Essentially bacteria endocarditis and he was deemed inoperable and he died. So in conclusion.
Repair of complex arch pathologies is feasible with the 3-branch Relay arch branch device. Experience obviously is very limited. Proper patient selection important. And the third antegrade branch is useful for later thoracoabdominal access.
now other causes this is a little bit different different scenario here but it's not always just as simple as all
there's leaky valves in the gonadal vein that are causing these symptoms this is 38 year old Lafleur extremity swelling presented to our vein clinic has evolved our varicosities once you start to discuss other symptoms she does have
pelvic pain happiness so we're concerned about about pelvic congestion and I'll mention here that if I hear someone with exactly the classic symptoms I won't necessarily get a CT scan or an MRI because again that'll give me secondary
evidence and it won't tell me whether the veins are actually incompetent or not and so you know I have a discussion with the patient and if they are deathly afraid of having a procedure and don't want to have a catheter that goes
through the heart to evaluate veins then we get cross-sectional imaging and we'll look for secondary evidence if we have the secondary evidence then sometimes those patients feel more comfortable going through a procedure some patients
on the other hand will say well if it's not really gonna tell me whether the veins incompetent or not why don't we just do the vena Graham and we'll get the the definite answer whether there's incompetence or not and you'll be able
to treat it at the same time so in this case we did get imaging she wanted to take a look and it was you know shame on me because it's it's a good thing we did because this is not the typical case for pelvic venous congestion what we found
is evidence of mather nur and so mather nur is compression of the left common iliac vein by the right common iliac artery and what that can do is cause back up of pressure you'll see her huge verax here and here for you guys
huge verax in that same spot and so this lady has symptoms of pelvic venous congestion but it's not because of valvular incompetence it's because of venous outflow obstruction so Mather 'nor like I mentioned is compression of
that left common iliac vein from the right common iliac artery as shown here and if you remember on the cartoon slide for pelvic congestion I'm showing a dilated gonna delve a non the left here but in this case we have obstruction of
the common iliac vein that's causing back up of pressure the blood wants to sort of decompress itself or flow elsewhere and so it backed up into the internal iliac veins and are causing her symptoms along with her of all of our
varicosities and just a slide describing everything i just said so i don't think we have to reiterate that the treatments could you go back one on that I think I did skip over that treatments from a thern er really are also endovascular
it's really basically treating that that compression portion and decompressing the the pelvic system and so here's our vena Graham you can see that huge verax down at the bottom and an occluded iliac vein so classic Mather nur but causing
that pelvic varicosity and the pelvic congestion see huge pelvic laterals in pelvic varicosities once we were able to catheterize through and stent you see no more varicosity because it doesn't have to flow that way it flows through the
way that that it was intended through the iliac vein once it's open she came back to clinic a week later significant improvement in symptoms did not treat any of the gonadal veins this was just a venous obstruction causing the increased
pressure and symptoms of pelvic vein congestion how good how good are we at
Thank you, Mr Chairman. In order to avoid unnecessary repetition, I'm going to try to move forward with some of my slides. There we go. And, again, in order to avoid that, we're just going to move through the cases. I have some cases that are different
to the ones presented before. It seems that everybody's happy with this technology. This is a CTO recanalization of a patient with subacute total occulsion of the SFA that previously had a stent in place,
in the distal SFA. And here you can see how we are able to reopen the vessel and look at the clot in the entire length at the end of the catheter there. So, this technology really works.
Let me show you now an acute bowel ischemia case. A patient that comes with abdominal pain. A CTA shows that the patient has an occlusion of the proximal SMA. We put a catheter there,
we do a diagnostic angiogram confirming the occlusion, then we cross the lesion and we inject distali showing that the branches are patent. And then we put in place
an oscar directional sheath that will give us great stability to work and through that one we use a Cat Eight, from Penumbra. As you can see here, advancing the catheter in combination with the separator,
and this is the final angiogram showing complete opening of the main SMA and you can see very clearly the elements that were occluding the MSL. We are also using this technology in DVT, acute DVT, with proprietal access
and here you can see the before, and then, sometimes we use it alone, sometimes we use it in combination with angiojet and with the bull spray, followed by this technology for the areas that did not respond.
But this is usually a technology that is helping us to get rid of most of the clot. Like here, you see there is some residual clot. And after Penambra, you can direct the catheter and you can really clean the entire vein. Same here, before and after.
We are also using it for PE. I know that you guys in Miami are doing the same and we are happy with the results. And then, just to finish, I think this is a really nice case that was done by one of our partners in vascular surgery.
A patient with an occluded carotid subclavial bypass. So you see access from the brachial artery on one side. And this person, the person who did this, was smart enough to also came from the groin
and put the filter in the internal carotid artery, just in case. So then he starts to manipulate that occluded subclavial carotid bypass. As you can see here. And at a certain point,
he does a follow-up angiogram showing that the entire carotid, including the internal and external, is totally occluded. So, because he was prepared, he had a filter,
he didn't panic, he went and used the indigo device, and he was able to get all that clot out and re-establish nice anterial flowing in the carotid artery,
completely clean. The carotid subclavial bypass. And he did a final angiogram in AP and lateral view, confirming that there is no distimbolisation at the intercranial level. So, this technology really works.
I think that we all agree. And these are good examples on how we can help patients with that technology. Thank you for your attention.
interventional research once again China because prior to the 1950s obviously with the Communist revolution and the socialist revolution there it was a kind
of very closed off country but in the past ten years of research true interventional radiology research has increased tenfold because of the opening of domestic borders because of the more internationalization
of China they actually started submitting things into international journals started looking at their IRB processes and I think we will see even more so you're gonna see more and more complex research coming out of China
they've applied more stringent application of IRB standards which has allowed their research to be more acceptable outside of China and the one thing that makes it hard for China to actually produce a high volume of
research is that they get no government funding there's no NIH to be able to provide specific standard funding and there's no medical device company to do funding as well so it's basically academic Hospital making a decision to
do a study and paying for the study that's the one limitation they do have specifically for interventional radiology and producing more relevant and pertinent to academic studies so
let's move on here is another patient who took a fall skiing we see a lot of these patients up in upstate New York and they presented with severe left-sided abdominal pain and here's the cat scan
all right who's up for it what do you think what looks bad you look like you're into it what do you think yeah the right the bottom right-hand side of the picture should be spleen and it just looks like a big pool of blood that's
pretty good you did pretty good spleens a little higher so we're gonna presume spleen is there Graham this is just one image one slice through the picture through the body so we're just not at the level of the spleen but that's the
kidney that's exactly right that white thing on the right side of the image of the patient's left side is the kidney and the one thing I'd like everyone who appreciates that doesn't look at all like the other side all right so when
you look at a cat-scan like this you want to look for symmetry that's really important all right that's the cool thing is we're kind of meant to be similar looking on both sides of our body and in this particular
case you can see that the left kidney has been pushed way forward in the body compared to the right side and there is a kind of a hematoma sitting in the retroperitoneum posterior behind the kidney that's bad
the other thing you should notice is if you look at that left kidney you notice that white squiggly line that doesn't belong there okay that's contrast that's not really constrained inside an artery that's extravagant of
contrast that's bad all right we don't want to see that all right again there's a grading system for renal trauma and you're gonna hear people talk about grade 1 2 3 4 injuries all right obviously as the number gets higher the
extents of the injury gets more significant all right so again here's that picture think you can appreciate that it's at least a grade 4 laceration of the kidney so we went in and we did an angiogram now we can watch these
patients we can surgically manage them by taking out their kidney in some ways that's the easy part excuse me it's a lot more elegant to try and embolize these patients if they're hemodynamically stable and can take you
know getting to angio and doing the case now in general we do embolization for patients with lower grade injuries and usually penetrating injuries a penetrating trauma that's seen on CT I think this is something that's changing
I if any of you work at high-volume trauma centers the reality is that we're doing more and more renal angiography for trauma than we used to because it's just becoming a more accepted thing for us to
be doing that all right so here's the angiogram and again I think you can notice it really correlates very well to what we saw on the CT scan you see that first image on the left and on the delayed image you see that that kind of
poorly constrained contrast going out into space now we were never really quite sure what this was if it was extravasation or if it was potentially an arteriovenous fistula with early filling of a renal vein regardless of
which it's not normal all right so what we did was we went in and we embolized and I only included this picture because I'm a big drawer during cases so when I'm working with a resident or a fellow I like to really
lay out our plan on a piece of paper and try and stick to the plan and this particular picture look really good so I included on the lecture but basically you can see that the coils the goal here for any embolization procedure
when it comes to trauma is to preserve as much of the normal organ as we can and to simply get you know to the source of the bleeding and to get it to stop and that's what we did there so what you can appreciate on this is kind of the
renal parenchyma or the tissue of the kidney is largely maintained you can see the dark black kind of blush within the kidney and all that really stands for properly working kidney all right and yet we embolize the pathology so that's
our goal here's a similar patient not
thank you so much for inviting me and to speak at this session so I'm gonna share with you a save a disaster and a save hopefully my disclosures which aren't related so this is a 59 year old female she's lovely with a history of locally advanced pancreatic cancer back in 2016
and and she presented with biliary and gastric outlet obstructions so she underwent scenting so there was a free communication of the biliary system with the GI system she underwent chemo and radiation and actually did really well
and she presents to her local doctor in 2018 with ascites they tap the ascites that's benign and they'll do a workup and she just also happens to have n stage liver disease and cirrhosis due to alcohol abuse in her life so just very
unlucky very unfortunate and the request comes and it's for a paracentesis which you know pretty you know standard she has refractory ascites and because she has refractory ascites tips and this is a problem because the pointer doesn't
work because a her biliary system is in communication with the GI system right so there's lots of bugs sitting in the bile ducts because of all these stents that have opened up the bile duct to list to the duodenum and so you know
like any good individual I usually ask my colleagues you know there's way more smart people in the world than me and and and so I say well what should I do and and you know there was a very loud voice that said do not do a tips you
know there there's no way you should do a tips in this person maybe just put in a tunnel at drainage catheter and then there was well maybe you should do a tips but if you do a tips don't use a Viator don't use a covered stand use a
wall stunt a non-covered stunt because you could have the bacteria that live in the GI tract get on the the PTFE and and you get tip situs which is a disaster and then there was someone who said well you should do a bowel prep you
like make her life miserable and you know give her lots of antibiotics and then you should do a tips and then it's like well what kind of tips and they're like I don't know maybe you should do a covered said no not a covered tonight
and then they're you know and then there was there was a other voice that said just do a tips you know just do the damn tips and go for it so I did it would you know very nice anatomy tips was placed she did well
the next day she has fevers and and her blood cultures come back positive right and you can see in the circle that there's a little bit of low density around the tips in the liver and so they put her on IV antibiotics and then they
got an ultrasound a week later and the tips that occluded and then they got a CT just to prove that the ultrasound actually worked so this really hurt my gosh to rub it in just to rub it in just just to confirm that your tips occlude
it and so you know I feel not so great about myself and particularly because I work in an institution that defined tip seclusion was one of the first people so gene Laberge is one of my colleagues back in the day demonstrated Y tips
occludes and one of the reasons is because it's in communication with the biliary system so bile is very toxic actually and when it gets into the the lining of the tips it causes a thrombosis and when they would go and
open these up they would see green mile or biome components in the in the thrombus so I felt particularly bad and so and then I went back and I looked and I was like you know what the tips is short but it's not short in the way that
it usually is usually it's short at the top and they people don't extend it to the to the outflow of the hepatic vein here I hadn't extended it fully in and it was probably in communication with a bile duct which was also you know living
with lots of bacteria which is why she got you know bacteremia so just because we want to do more imaging cuz you know god forbid you know you got the ultrasound of her they because she was back to remake and
you know that and potentially subject they got an echo just to make sure that she doesn't have endocarditis and they find out that she has a small p fo so what happens when you have a thrombosed tips you go back in there and you do a
tips or vision you line it with a beautiful new stent that you put in appropriately but would you do that when the patient has a shunt going from one side of the heart to the other so going from the right to the left so sort of
similar to that case right and so what do we do so I you know certainly not the smartest person in the room we've demonstrated that so I go and I asked my colleagues and so the loud voice of saying you know I told you this is why
we don't practice this kind of medicine and then there was someone who said why don't we anticoagulate her and I was like are you kidding me like you know do you think a little lovenox is gonna cure this and then the same person who said
we should do a tunnel dialysis tile the tunnel drainage catheter or like a polar X was like how about a poor X in here like thanks man we're kind of late for that what about thrombolysis and then you
know the most important WWJ be deed you guys are you familiar with that no what would Jim Benenati do that's that's that's the most important thing right so so of course you know I called Miami he's you know in a but in a big case you
know comes and helps me out and and I'm like what do I do and you know he's like just just go for it you know I mean there are thirty percent of the people that we see in the world have a efo it's very small and it probably doesn't do
anything but you know I got to tell you I was really nervous I went and I talked to miner our colleagues I made sure that the best guy who was you know available for stroke would be around in case I were to shower emboli I don't even know
what he would do I mean maybe take her and you know thrombolysis you know her like MCA or something I don't know I just wanted him to be around it just made me feel good and then I talked to another one of my favorite advisors
buland Arslan who who also was at UVA and he said why don't you instead of just going in there and mucking around with this clot especially because you have this shunt why don't you just thrown belay sit and then you
know and then see what happens and so here I brought her down EKOS catheter and I dripped a TPA for 24 hours and you know I made her do this with local I didn't give her any sedation because I wanted and it's not so painful and I
just wanted her to be awake so I could make sure that she isn't you took an intervention location you turned it into internal medicine I I did work you know that's that's you know I care right you know we're clinicians and so she was
fine she was very appreciative I had a penumbra the the the Indigo system around the next day in case I needed to go and do some aspiration thrombectomy and what do you know you know the next day it all opened up and you can still
see that the tips is short the uncovered portion which is which is you know past the ring I'm sorry that which is below the ring into the portal vein is not seated well so that was my error and and there was a little bit of clot there so
what I ended up doing is I ended up balloon dilating it placing another Viator and extending it into the portal vein so it's covered so she did very
we talk about there's three different
levels of hospitals now much like the US you're gonna have major tertiary institutions which your large academic centers you're gonna have your smaller centers which are kind of more of your like mid local community hospitals and
then you're gonna have your very small hospitals and China it's a three tier system you have the primary tier which is defined as less than a hundred beds and that's gonna be very limited access that's normally your holistic
medications you're gonna have a lot of TCM traditional chinese medicine practitioners there and they're more worried about health than they are about intervention if you're in a very small town and you have something that you
need done you're probably not gonna go to a tier a primary tier system hospital you just won't be able to get the intervention you don't start seeing interventional radiology till you get to the second tier and that's not only
between 100 and 500 beds and it's mostly moderate size cities that have these and they have your average intervention they'll do basic things like basic biopsy maybe basic line access you won't see many high-end procedures there and
then you have much larger hospitals with your tertiary care centers and those are the ones that have access to the u.s. products the the European products and well tell you in China it's kind of an interesting model of care when you were
looking for availability to be able to treat your patients those tertiary hospitals very much favored using american-made products and devices as well as your pain made products you can't get that in the secondary
hospitals they're either gonna be all Chinese made products you may get some that were made over in other countries in Asia but they certainly are not gonna be the American made products and the reason for that is any product made
outside of China a patient has to pay for it makes intervention not only frustrating but very complex at times and I'll explain that kind of Maya my quick experience with that as well so
- Thank you for the opportunity to present this arch device. This is a two module arch device. The main model comes from the innominated to the descending thoracic aorta and has a large fenestration for the ascending model that is fixed with hooks and three centimeters overlapping with the main one.
The beginning fenestration for the left carotid artery was projected but was abandoned for technical issue. The delivery system is precurved, preshaped and this allows an easy positioning of the graft that runs on a through-and-through wire from the
brachial to the femoral axis and you see here how the graft, the main model is deployed with the blood that supported the supraortic vessels. The ascending model is deployed after under rapid pacing.
And this is the compilation angiogram. This is a case from our experience is 6.6 centimeters arch and descending aneurysm. This is the planning we had with the Gore Tag. at the bottom of the implantation and these are the measures.
The plan was a two-stage procedure. First the hemiarch the branching, and then the endovascular procedure. Here the main measure for the graph, the BCT origin, 21 millimeters, the BCT bifurcation, 20 millimeters,
length, 30 millimeters, and the distal landing zone was 35 millimeters. And these are the measures that we choose, because this is supposed to be an off-the-shelf device. Then the measure for the ascending, distal ascending, 35 millimeters,
proximal ascending, 36, length of the outer curve of 9 centimeters, on the inner curve of 5 centimeters, and the ascending model is precurved and we choose a length between the two I cited before. This is the implantation of the graft you see,
the graft in the BCT. Here, the angiography to visualize the bifurcation of the BCT, and the release of the first part of the graft in the BCT. Then the angiography to check the position. And the release of the graft by pushing the graft
to well open the fenestration for the ascending and the ascending model that is released under cardiac pacing. After the orientation of the beat marker. And finally, a kissing angioplasty and this is the completion and geography.
Generally we perform a percutaneous access at auxiliary level and we close it with a progolide checking the closure with sheet that comes from the groin to verify the good occlusion of the auxiliary artery. And this is the completion, the CT post-operative.
Okay. Seven arch aneurysm patients. These are the co-morbidities. We had only one minor stroke in the only patient we treated with the fenestration for the left carotid and symptomology regressed completely.
In the global study, we had 46 implantations, 37 single branch device in the BCT, 18 in the first in men, 19 compassionate. These are the co-morbidities and indications for treatment. All the procedures were successful.
All the patients survived the procedure. 10 patients had a periscope performed to perfuse the left auxiliary artery after a carotid to subclavian bypass instead of a hemiarch, the branching. The mean follow up for 25 patients is now 12 months.
Good technical success and patency. We had two cases of aneurysmal growth and nine re-interventions, mainly for type II and the leak for the LSA and from gutters. The capilomiar shows a survival of 88% at three years.
There were three non-disabling stroke and one major stroke during follow up, and three patients died for unrelated reasons. The re-intervention were mainly due to endo leak, so the first experience was quite good in our experience and thanks a lot.
I think we've talked a lot about this all through the this conference and with
our SAR partners about the vulnerabilities into the procedure areas we have a heightened risk of adverse events in procedures that are happening in nan-oh our areas ironically you know again the patients are twos deemed too
sick to go to the OU are and they come down to a remote area an interventional radiology hence the need for standards and streamlining and communicate and collaboration again we have you know increased acuity of our patient
population again increased volume of low-risk procedures on high-risk patients remote settings within the hospital our interventional radiology suite was buried behind our radiology department behind Diagnostics it was you
know signage wasn't very good and you know it was behind two double doors that needed to have badge access so that was oftentimes you know something it's minor but it was major when there was an emergency there was a lack of
significant team-building training and I can talk we'll talk a little bit about what kind of things you can do in your organization's that are really low cost for team-building training and then the procedure lists we know that they're
experts in their procedures but they're not trained in crisis management so and they you know luckily I have a team and I had a team of physicians that were aware of that and so we worked on methods of changing that supporting them
and supporting our team so again safety
- So I don't have to give you any data. I just have to tell you how we do it. So this is the easiest talk of this session. Step-by-step technical tips. Now our definition of pharmaco-mechanical may vary between us so I'll give that as we go along. These are my conflicts.
When to use it. Well certainly as you already heard, Massive PE has contraindication to full dose lytic is one area. Submassive elevated risk may be another. We've already seen multiple people put up
these guidelines so what we're really talking about at this point in time is those patients that we just talked, that those two groups that they just talked about because those are the ones that we're trying to treat. The biggest thing is don't be frozen by indecision.
Majority of patients eligible for thrombolysis do not receive it. It's amazing to me as a referral center to get the call from an outside community hospital or the patient with hypotension, abnormal RV or biomarkers and they've barely given the patient
Heparin and they just want to transfer the patient out of there and you tell them that's a massive PE. Please give them systemic thrombolysis and they go what? And I go you now have 10 times the death rate of an acute myocardial infarction. Would you give this patient lytics for acute MI?
Yes. Then give them the freaking lytics. Save their life. It's amazing what's going on in this country. So the PERT Consortium and everything, we really need to educate the community
because it's ridiculous. If you look at the utilization of thrombolysis, it's going down. Unbelievable and if you look at the in-hospital mortality for these patients that have significant PE, the in-hospital mortality is much higher
if you don't give thrombolysis. You've already seen this indirectly in a bunch of different lectures, but I just wanted to show you very quickly how to do this on an echo or CT. You want to get the center line, get it at the valve and then measure it one centimeter
below that valvular plane. This is something you don't have to depend on radiology just to do. You can just look at the transfer CT. You can look at the echo. You don't have to fight with your echo guy to give you that.
It's also very evident and often times just looking at the images. Why treat submassive elevated risk PE? You know what? I've heard all the mortality stuff. I get it.
It doesn't change mortality that much. It does and we should measure it as a primary endpoint in our trials. Change your discharge time and in this day and age, medicine is so expensive. Time in the hospital, repeat procedures,
elevated your amount of treatment for that patient really has to be looked at as part of that, not just mortality. But there's eight times more recurrent PE and four times a mortality rate if you have a PE and unresolved RV dysfunction at discharge
and that should be looked at prior to discharge, not just say well they look like they're doing okay. Treatment of IVC, higher risk PE. Certainly the other thing we have to look at is there's other things to do. You've already heard a little bit
that there's IVC filters out there. We take out 90 some percent of our IVC filters in our section. We actually as a system now are up to 60% at seven months and it only takes effort. The patients that I see die in our hospital
in the last year that shouldn't have died are patients that should've gotten an IVC filter because they got heroic things to take out their PE and nobody put a filter in even though they had significant DVT left over because they were afraid of the TV commercials?
Oh my gosh. If you look at the 27 extra deaths that we've had from IVC filters that were removable in the United States, and you take our experience and multiply it by the number of tertiary care hospitals in the United States, use them when they're appropriate.
Take them out so the risk is low, but don't go away from them. They've already been shown to be beneficial for the right patient population. But you also have embolectomy and surgery should also be considered.
Step by step. Make the decision and clinically be consistent. PERT team or other consistent mechanisms. We have an app that we use. This is throughout our entire healthcare system so all the vascular specialists have this.
It's an algorithm that's supposed to be used both in the ER and for the different vascular specialties so everybody's being treated very similarly. We have all the different definitions. We have the PESI calculator. All this is in an app
that's readily available to our constituents. Special consideration certainly is the tolerance of thrombolysis, underlying tolerance of pulmonary hypertension. Again, we need to evaluate the patient, not just label them as a PE.
And I also think there's a special population we need to study and that's the socked in pulmonary artery with no perfusion on a CT scan. I think this is a different population long term and we need to study that a little bit more. We got to get the patient back from the edge.
I think I'm opposite of Jeff. I don't want to see them get worse and then treat 'em. I want to prevent them from getting worse as long as I'm selecting that population in a thoughtful matter. We primarily use low dose TNK.
This is nothing I'm going to give you data on. This is an institutional, what do you want to call it, anecdotal experience and we lost our contracts except for TNK so we had to go to this and so we do a lot of catheter-directed. You've already seen all these trials.
There's a ton of different devices out there. The one I want to talk to you about is using a really fancy one called a pigtail catheter and another one called an ethos catheter. This is a patient that had a significant PE. You can see that they've got bilateral main PE.
This is on table. This is what we do for the vast majority of our patients. We sit there, we use ultrasound guided access to the vein so that we cut down our venous complications for access site. The patient is given 20 and 30% of a loading dose
of TNK and then we watch them. If you look at thrombus in a test tube and you give a thrombolytic therapy, it takes about 20 minutes for fibrinolysis. So this is what we do. As you're going to see, this is over 25 minutes
and we see the patient went from a pulmonary pressure of 65 and a heart rate of 115 down to 25 minutes, the patient's pulmonary pressure is about 44 and their heart rate is in the 90's. This patient then has all the catheters removed on the table even though they got lytic
and they're heparinized. This is a venipuncture, so big IV. We send them up to the unit and we typically discharge them the next day. We have an echo B4 discharge to make sure there's been a significant recovery of RV.
If not we'll watch them an extra day and then all these patients get a CT again. I'm sorry an echo again at 30 days to make sure that we're getting good resolution from that. On table results, decrease your complications. Thrombolysis has always been associated with the
duration of thrombolytic therapy and intracranial bleed. Now you can either use a pigtail catheter which is what we use for most of these people because we can measure pressure in it. We spin it around a little bit in the pulmonary arteries and give the dosage.
Again, we give 20-30% of the dose. There is no data for that. If significant improvement does not occur, they'll get dripped overnight in the ICU at usually .5 to 1 milligram per hour. You've already seen the data for EKOS.
We use this if we think we need a little bit quicker Thrombolysis such as in a socked in pulmonary artery 'cause we have no flow. We do think that may help, but we don't have any data for that. It makes us feel good.
We spend a lot more money and so we think that may be reasonable at that point in time. This is just what it looks like when you put in bilateral EKOS catheters. Certainly the patient can be put in the ICU for this. I do think that we should do a trial looking at EKOS
with a little higher dose, do it for 30 minutes, look at those pulmonary pressures right on the table. I think, again, my own opinion is after 25 years, the closer we get to being done on table, catheters out, patients doing well, the better, safer procedure we have,
the less chance of mortality, the less chance of complication and as you decrease complications, your benefit improves. We've already seen the results and you'll see more of these from non-randomized trials such as Seattle 2 which looked at 150 patients,
but they saw very quick recovery of the RV which was very important. If you look at technical success, it was very high. The dosage of thrombolytic exceedingly lower, lower than what we're giving in a PTO catheter, that's for sure.
And if you look at the RV from Ultima Trial which was randomized. There was faster RV recovery utilizing this device. Thank you very much.
no way around this I'm gonna read to you the inclusion criteria right off the protocol it's kind of long so confirmed diagnosis I wrote some single line there that can help you follow along confirm diagnosis of HCC number two patients
above age 23 patients with single or multiple nodules HCC who are unsuitable or unwilling for surgical resection or RFA the largest tumor nodule should be less than 10 centimeters in the large largest diameter total volume of tumor
cannot exceed 50% of the liver patients are candidates for trans arterial embolisation no tumor invasion to portal vein or thrombosis and main and first branch of the portal vein 5 patients have no lymph node involvement or
distant metastasis 6 ECoG score at 0 to 1 with no known cardiac pulmonary or renal dysfunction 7 child pew score group a and B 7 eight patient should have measurable disease by contrast MRI nine prior local
therapies such as surgical resection radiofrequency ablation and alcohol injection are allowed as long as tumor progresses from the prior treatment and the patients are still candidates for tae 10 patients have normal organ
function based on some labs eleven patients are able to understand and willing to sign the informed consent and twelve men and women of childbearing age need to commit to using two methods of contraception and the exclusion criteria
you know the most common procedures in China this is kind of interesting I was blown away by this when I did the research on this I knew when I would go
into the hospitals and I was all over for I've been to Beijing shanghai nanjing to even the smallest little place is up in northern china and the one thing that blew me away I'm looking at the board and I'm seeing neuro case
after neuro case after neuro case I'm like it got 10 Narrows and and a pic line I'm like it's an interesting interesting Dysport of cases and the reason being is in China they consider diagnostic neuro
so neuro angio to be the primary evaluating factor for any type of neurological issue so you're not getting a CT if you come in with a headache you think you're gonna go get that cat scan now it's generally what not what they do
so you're talking about a case and I'll give you the case matrix of the break-up it's just proportionately high for a neuro very well trained in neuro and most of the guys that are trying to neuro very similar to what dr. well Saad
said a lot of the guys in Africa are trained in France so other neuro interventions have trained in France or lipstick in China and have received European training on that so you know the level of what they're doing some of
the stroke interventions some of the ways they're going after these complex APM's they'll Rob well anything you'll see here in the US so it is quite interesting to see and the second
largest is taste hepatocellular carcinoma is on the rise it's the highest level in the world is found in China and Korea for that matter and there's many reasons why we can go into it some of it is genetic factors and a
lot of societal factors alcohol is a very liberally lie baited in China and there is problems with you know cirrhotic disease and other things that we know could be particular factors for HCC so always found that very
interesting like I said I would go into a hospital and I'll see a PICC line a hemodialysis catheter and then 20 tase's on the board in one day so it is quite interesting how they do it and then biliary intervention stents tips and
then lung ablation you know the highest rates of HCC biliary cancer and lung cancer found in China and once again when we talk about lung cancer what are those contributing factors you're talking about certainly a genetic
component but mostly it's lifestyle factors smoking is prevalent in the US and in you know in Europe and in some areas in Asia we've seen obviously a big reduction in smoking which is fantastic China not so much you don't see that
it's a societal thing for them and unfortunately that has led to the the largest rates of cancer in the world in lung cancer so lung ablation is a big procedure for them over there as well so procedure breakdown this is kind of some
of that breakdown I was telling you about that cerebral procedure is some of the most commonly performed and you're talking about at very large numbers they're doing neuro intervention because they do it for die
Gnostic purposes and I would that kind of blew me away when I found out they do have cast scanners and certainly for trauma and things like that they'll do it but the majority of the stuff if you come in you have headaches you might end
up in the neuro suite so it's quite interesting how they can do that tumor intervention very high like I said you have the highest rates of HCC in the world you're getting cases they do have y9t available and in fact China just
made their largest acquisition ever with the by what you guys know a company they bought surtex there's a Chinese company now it got bought by China now the interesting is they don't currently have a whole lot of
y9t over there but they just opened up some of their own generators so they can actually start producing the white room 90 and I think you'll see probably a increase in those numbers of y9t cases but to date the number one procedure for
them is taste and they do a lot of them you know like I said on average a community hospital setting you might find 15 or 20 cases a day with three interventionalists so compared to what you guys do there's probably not many
people here unless you're working at a major institution that there's nothing but cancer doing 20 cases a day and I promise you're probably not doing it with only two interventionalists so it's amazing how fast and effective they've
gotten at and below therapy and unfortunately it is necessary because of those elevated HCC levels and like I said when we look at some of these things it's I go over there and I'm looking at the board there are very few
cases for you know PICC lines very few the frosted grams very new bread-and-butter abscess training procedures like we do here in the US they are very it's the prevalence is very simple it's neuro it stays and it's
biopsy and those are some kind of the big three for intervention in China and there it's such a large volume you get to learn a lot when you're over there and CLI PA D even though it's more prevalent in China than it is here
because smoking lifestyle factors certainly westernization of the diet in China which occurred since the 1950s and 60s has led to a lot of McDonald's and and fast food and things that weren't currently available prior to 1950s you
see a lot of PA d but it is very undertreated and certainly talking to some of my colleagues like whom are oh you'll get to see a little bit later on with CLI fighters one of the things that's kind of frustrating for them is
that it is so undertreated it's very common to see amputations in China instead of actually doing pipe in percutaneous intervention they normally like to go too far and you see a lot of amputation certainly above
normal so that's something I think as an interventional initiative when we look at these things coming from a Western perspective it's definitely something we need to pursue a little more aggressively but there it's very little
oh well you're talking about two you know two to three percent you know maybe up to six percent or PID cases very very low levels so equipment in equipment in
- So this is what I've been assigned to do, I think this is a rich topic so I'll just get into it. Here are my disclosures. So I hope to convince you at the end of this talk that what we need for massive PE when we're talking about catheter based therapy is a prospective registry. And what we need for catheter based therapy for
submassive PE is a randomized controlled trial. So we'll start with massive PE and my rational for this. So you know, really as you've heard, the goal of massive PE treatment is to rescue these patients from death. They have a 25 to 65% chance of dying
so our role, whatever type of physician we are, is to rescue that patient. So what are our tools to rescue that patient? You've heard about some of them already, intravenous thrombolysis, surgical embolectomy, and catheter directed therapy.
The focus of my talk will be catheter directed therapy but let's remember that the fastest and easiest thing to do for these patients is to give them intravenous thrombolysis. And I think we under utilize this therapy and we need to think about this as a first line therapy for massive PE.
However, there's some patients in whom thrombolytics are contraindicated or in whom they fail and then we have to look at some other options. And that's where catheter directed therapy may play a role. So I want to show you a pretty dramatic case and this was an eye-opening case for me
and sort of what launched our PERT when I was at Cornell. It's a 30 year old man, transcranial resection of a pituitary tumor post-op seizures and of course he had a frontal lobe hemorrhage at that time. Sure enough, four or five days after this discovery
he developed hypertension and hypoxia. And then is he CT of the chest, which I still remember to this day because it was so dramatic. You see this caval thrombosis right, basically a clot in transit
and this enormous clot in the right main pulmonary artery. And of course he was starting to get altered, tachycardiac and a little bit hypotensive. So the question is, what to do with this patient with an intracranial hemorrhage? Obviously, systemic thrombolytics are
contraindicated in him. His systolics were in the 90 millimeter of mercury ranged, getting more altered and tachycardiac. He was referred for a CDT and he was brought to the IR suite. And really, at this point,
you could see the multidisciplinary nature of PE. The ICU attending was actively managing him while I was getting access and trying to do my work. So this was the initial pulmonary angiogram you can see there's absolutely no flow to the right lung even with a directed injection
you see this cast of thrombus there. Tried a little bit of aspiration, did a little bit of maceration, even injected a little TPA, wasn't getting anywhere. I was getting a little bit more panicked as he was getting more panicked
and I remembered this device that I had used in AV fistula work called the Cleaner. Totally off label use here, I should disclose that and I have no interest in the company, no financial interest in the company. And so we deployed this thing, activate it a few times,
it spins at 3,000 rpm's, he coughed a little bit, and that freaked us all out also. But low and behold we actually started seeing some profusion. And you can see it in the aortogram actually in this and that's the whole point of massive PE treatment with CDT,
is try to get forward flow into the left ventricle so that you have a systemic blood pressure. Now, you know, when we talk about catheter based therapies we have all sorts of things at our disposal. And my point to you is that you know really, thank you...
You guys can see that, great. So really, the point of these catheter therapies is that you can throw the kitchen sink at massive PE because basically your role is to try to help this patient live. So, if I can get this thing to show up again.
There we go. It's not working very well, sorry. So, from clockwise we have the AngioVac circuit, you have, let's see if this will work again, okay. Nope, it's got a delay. So then you have your infusion catheter,
then you have the Inari FlowTriever, you saw the Cleaner in the previous cast, and you have the Penumbra aspiration device the CAT 8. And some of these will be spoken about in more detail in subsequent talks. But really, you can throw the kitchen sink at massive PE
just to do whatever it takes to get profusion to the left side. So, the best analysis that has been done so far was Will Kuo in 2009. He conducted a meta-analysis of about 594 patients and he found this clinical success rate of 86.5%.
This basically meant these patients survived to 30 days. Well, if that we're the case, that's a much lower mortality than we've seen historically we should basically be doing catheter directed therapy for every single massive PE that comes into the hospital. But I think we have to remember with this meta-analysis
that only 94 of these patients came from prospective studies, 500 came from retrospective, single center studies. So even though it was a very well conducted meta-analysis, the substrate for this meta-analysis wasn't great. And I think my point to you is that
we really are going to have a hard time studying this in a prospective fashion. So what is the data, as far as massive PE tell us and not tell us? Techniques are available to remove thrombus, it can be used if systemic lysis is contraindicated,
but it doesn't tell us whether catheter based therapies are better than the other therapies. Whether they should be used in combination with them and which patients should get catheter based therapy, which should get surgery and which techniques are most effective and safe.
Now, I think something we have to remember is that massive PE has a 5% incidence which is probably a good thing, if this was even higher than that we would have even more of an epidemic on our hand. But this is what makes massive PE very difficult to study.
So, if you looked at a back of the envelope calculation an RCT is just not feasible. So in an 800 bed hospital, you have 200 PE's per year, 5% are massive which means you get 10 per year in that hospital, assume 40% enroll which is actually generous,
that means that 4 massive PE's per year per institution. And then what are you going to do? Are you going to randomize them to IV lytics versus surgery versus interventional therapy, a three arm study, what is the effect size, what difference do you expect between these therapies
and how would you power it? It's really an impossible question. So I do want to make the plug for a Massive PE Prospective Registry. I think something like the PERT consortium is very well-suited to run something like this
especially with this registry endeavors. Detailed baseline characteristics including all these patients, detailing the intervention and looking at both short and long-term outcomes. Moving on to submassive PE. As you've heard much more controversial,
a much more difficult question. ICOPER as you already heard from the previous talk, alerted the world to RV dysfunction which this right ventricular hypokinesis conferring a higher mortality at 90 days than no RV dysfunction. And that's where PEITHO came in as you heard.
This showed that the placebo group met the primary endpoint of hemodynamic decompensation more commonly than the Tenecteplase group. Of course, coming at the risk of higher rate of major bleeding and intracranial hemorrhage. So I just want to reiterate what was just said
which is that systemic thrombolysis has a questionable risk benefit profile and most patients with submassive PE, as seen in the guideline documents as well. So that sort of opens a sort of door for catheter directed therapy.
Is this the next therapy to overcome some of the shortcomings of systemic thrombolysis? Well what we have in terms of CDT is these four trials, Ultima, Seattle II, Optalyse, and Perfect. Three of these trails were the ultrasound assisted catheter, the Ekos catheter.
And only one of them is randomized and that's the Ultima trial. I'm going to show you just one slide from each one of them. The Ultima trial is basically the only randomized trial and it showed that if you put catheters in these patients 24 hours later their RV to LV ratio will be lower
than if you just treat them with Heparin. Seattle II is a single arm study and there was an association with the reduction in the RV to LV ratio at 48 hours by CTA. PERFECT, I found this to be the most interesting figure from PERFECT which is that you're going to start it at
systolic pulmonary artery pressure of 51 and you're going to come down to about 37. Optalyse, a brand new study that was just published, four arms each arm has increasing dose associated with it and at 48 hours it didn't matter, all of these groups had a reduction in the RV to LV ratio.
And there was no control group here as well. What is interesting is that the more thrombolytics you used the more thrombus you cleared at 48 hours. What that means clinically is uncertain at this point. There is bleeding with CDT. 11% major bleeding rate in Seattle II,
no intracranial hemorrhages. Optalyse did have five major bleeds, most of the major bleeds happened in the highest dosed arms. So we know that thrombolytics cause bleeding that's still an issue. Now, clot extraction minus fibrinolytic,
this is an interesting question. We do have devices, you're going to hear about the FLARE trial later in this session. EXTRACT-PE is ongoing which we have enrolled about 75 patients into. What the data does and does not tell us
when it comes to CDT for submassive PE it probably reduces the RV to LV ratio at 24 hours, it's associated with a reduction at 48 hours, major bleeding is seen, we do not know what the short and long-term clinical outcomes are
following CDT for submassive PE. Whether it should be routinely used in submassive PE and in spite of the results of Optalyse this is a preliminary trial, we don't know the optimal dose and duration of thrombolytic drug. And even is spite of these early trials
on these non-lytic techniques, we don't know their true role yet. I'd liked to point out that greater than 1,600 patients have been randomized in systemic lytic trails yet only 59 have been randomized in a single, non-U.S. CDT trial.
So this means that you can randomize patients with submassive PE to one treatment or the other. And we want to get away from this PERT CDT roller coaster where you get enthusiasm, you do more cases, then you have a complication, then the number of cases drops.
You want that to be consistent because you're basing it on data. And that's where we're trying to come up with a way of answering that with this PE-TRACT trial. Which is a RCT of CDT versus no-CDT. We're looking at clinical endpoints
rather than radiographic ones greater than 400 patients, 30 to 50 sites across the country. So in summary I hope I've convinced you that we need a Prospective Registry for massive PE and a Randomized Controlled Trail for submassive PE. Thank you.
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