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Recent Global Peer-Reviewed Studies and Intraoperative Pain Scores
Recent Global Peer-Reviewed Studies and Intraoperative Pain Scores
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PET/MRI vs PET/CT | PET/MRI: A New Technique to Obtain High Quality Diagnostic Images for Oncology Patients
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What's Next | AVIR CLI Panel
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The Ways to Recanalize the Below the Knee Vessels | AVIR CLI Panel
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Transcript

these are all the published things my eye I actually was lucky enough to be asked by the company do the first man study we follow them over two years

closure rates were all here in the ninety percent or greater and these are the various times of follow-up that have been around a couple of things to want to point out you here in terms of compared to radiofrequency

postoperatively the pain was less in this Dutch study compared to a radio frequency and this is just the longest follow-up that we have thus far the really good thing about this and all the non-thermal non tumescence is you can

treat below the knee getting good also healing because you go all the way down underneath the officer you don't have to pass the message and these two studies address that you want you doing small saphenous and one with the great that it

does affect very positively also healing our rates there's a couple of studies that have in clinical trials this one has the results already which was just published last month info biology

this is from england comparing a mocha with radiofrequency intraoperatively in terms of the pain hundred twenty patients and they had a visual analog scale of zero to a hundred post-procedure quality of life and

closure rates were also a addressed and the for them the interrogative pain score was 19 the maxims for the mocha and 34 for radio frequency that was significant as well as the average interoperate so it is less painful of a

procedure according to this study obviously made because you're not doing to message they follow up for one month and no surprise i told you great saphenous vein is closed everything's the same clinical scores

quality-of-life scores it already heard about all wear the same all improved so we can take solace in the fact that we close this afternoon's however we do it if people are going to feel better at one month

the idea is intraoperatively before that month they may be better with a non-thermal in terms of discomfort and your pain just update on on some of the

you can pretty much put plastic at the end of any word you want so if you read or plasti whatever but not ablation truthfully it doesn't sound right ablation oblast ISA so as was mentioned my talk today and beyond ablation I have just one disclosure but consultant for

btg ablation so I guess just a quick raise of hands how many people are due oblations where they work I would hope nearly everyone okay perfect so I'm trying to sort of direct us towards the the way the oblation med modalities work

rather than procedural but we'll show some case examples of of where we can use these the three dominant modalities as many of you know are gonna be the radiofrequency ablation which is the oldest most common one used previously

cryoablation and then microwave ablation I'm not going to talk so much about Ayari it's considered one of the ablation modalities but it's really not done as commonly with ir around the country so we'll start with

radiofrequency ablation I suspect that many of you who are newer to I or maybe haven't used much RFA and people who have been in IR for a long time have used it quite extensively what we know

this is just happens to be a biliary

other classification system with bismuth how where the injury occurs and this is really germane after surgery so you'll see most of these actually after misadventure with bluish surgery and and like I said the most common ones

actually after laparoscopic surgery but we have barrier so we have oncological have two extremely complex three sections of the liver now and and we the advent and certainly rise are more balloon complications this is an example

of what we might do in the complex setting this patient had explorers in cholangitis primary cylinder current charges received a transplant and the transplant liver had a recurrence and with recurrent explorers and cholangitis

there was just no way we could cross it but even with a long-standing billy we drain frequently if you drain most obstructed systems a day or two passage across an inflamed structure it makes it much more easy and you will see their

people get brought back for their secondary tube with laryngitis sometimes this is not possible so we actually have made attempts to cross this there's no other way so we happen to use a sharp organization so we happen to use a

transept own needle and use a sharp needle go breakthrough sometimes analysis of the CT scan is a very important you really want to know what's between your one side and what's on the other side and the more even more fun

thing to do now is using our rfy off-label and we'll burn our way through and create the track that actually has a much better patency rates and even sharp organization your allow essentially coring of sort of in chronically

inflamed fibrotic tissue and allows you a chance of keeping this open it's just example of how you benchley burrow through with a shop another case with a sharp needle creating a track really that's not

natural because this is obviously a transplant patient and it's the only way through even done what we've done is stick the intestine first and then put us in a punch our way through polio stay out and

then thereby restoring the the track and they are sort of you have to be just really created with biliary disease when it comes to chronic obstructions or high-grade obstructions so like I said with benign the disease frequently it's

post-operative and so they will present in multiple different ways and most of the times they're just leaking in the intraperitoneal ich you you're you essentially peritoneal cavity will reabsorb it so patients get jaundice is

essentially it hi arrays but Rubens and you'd really can diagnose in many ways and really just dealing with this can be problematic and then so we've been dealing with bluish structures and and oh sorry benign Ballou strictures

post-operative benign Ballou strictures in a more labor-intensive way we actually leave tubes in for six months which is probably a little more than most people must be not a benign the Lewis structures are managed with three

months of stinting with a minimum of twelve French tube so that's a reason why some of these patients will get kalanchoe pasties multiple bluie a drained Rhys tenting it and tube exchanges and changed up this way and

then this is just happens to be the British is worth a typical we will get access cross the stricture kalanchoe plastic stretch out this benign structure and then place a tube in for as long as you can to keep it open and

fro asses of between three and six months there's a classic example someone who obstructed that they said this looks very smooth it doesn't look ugly and looks okay doesn't look like a cancer we sometimes what I so biopsy if it has any

suspicious appearance and then get across you can see even with a balloon how tight the structure can be with a high pressure balloon and there after placing achievement for again three to six months we actually err on the side

of caution almost our patients have six months of intubation which is quite long difficult and this is our experience what we do then is when do you remove it to actually have a sort of a step-by-step process we have a it's not

really medical clinical trials actually just if a flow clinical trial what we'll do is get the tubing bring a patient back and we actually cut the tube so there's only the access through the parenchyma of the liver is preserved but

nothing through the structure we will cap the tube is since you can maintaining access and see if the patient doesn't make sure that doesn't get fever the stricture is maintained and then we'll bring the patient back

after a week to do a balloon whiticus test that's really just a modification of a urinary radhika test we're going to take pressure measurements after slow contrast injections to make sure it remains the

patency and for us the data suggests we can essentially and predict over 90% who will be staying free if they pass the Whittaker test in keeping the monetary reading less than 20 centimeters of

water and really it allows us to manage these because of how many patients have what procedures at our institution we have a large volume of patients that we actually follow and it's a you know our fellows think it's the most common

procedure Billu intervention had this is actually not that coming everywhere else and this is what I believe tests we have a pro forma that we fill in and the contrast has been ejected in

certain rates per minute and so this test takes about 30 minutes we make sure that there's the predictive value of in less than less pressure building up over higher high contrast injection rates will give us a great prediction of no

longer needing the tube and then stone

we're going probes I think many of you have used our FA there's all sorts of different probes right so the most common well one of the most common ones is a probe like a Levine probe and what it does essentially is it increases the

number of tines so you put the probe in and you deploy these tines and it increases your ablation size a lot of companies went towards just a single probe and they infuse saline through the probe which will then decrease the rate

at which the temperature increases so that you get a consistent slow increase in temperature to prevent impedance other probes will actually infuse saline into the tissues so that it propagates the ablation better and then finally

there's by polar probes where you put two probes in next to one another and the the ablation occurs just between the two probes and so that's a very controlled ablation that's the most commonly what you see when you do the

spine augmentation procedures with the osteo cool system or whatever system you're using that's the bipolar probe approach so as I mentioned the

about RF a is that it was the first

ablation that we came up with all those that used it was first used in 1981 and it was really for the first liver ablation that we did RFA if any of you know about a Bovie knife the idea is the same the modality works the same as a

Bovie knife and still the main modality used in many parts of the world in the United States a lot of people will use it in certain areas but it's it's being slowly replaced by microwave ablation with time so as I mentioned some areas

are still using a fair amount of RF aimost or not I can honestly say that I haven't used much RF a at all I was sort of born into the generation of cryo and microwave places where we do use it or very commonly our Nerada meas for pain

control as well as spine ablations if any of you do the osteo cool system with Medtronic will do kyphoplasty in conjunction with an ablation that would be RFA and then Bowden oblations in conjunction with cement organizations

elsewhere right so in the pelvis if there's metastatic disease to the pelvis and you're going to ablate the lesion and then to cement augmentation the I

deal with radiofrequency ablation is that you have a probe which acts as the

calf the current you then have the pads which act as the anode and when you place the probe in turn it on essentially there's a very small cross-sectional area and there's high flux of energy so lots of

current and then it spreads out over the patient's body and it grounds itself to the grounding pad in so the way is since she works is you generate this very very large alternating current right so the water molecules want to stay in

conjunction with that that current their dipoles arrangement they have positive and minuses and so they're gonna flip around to stay in alignment with that current and that rapid oscillation of those water molecules causes the the

tissue to heat up the way a cinch it works is by coagulation necrosis what does that mean well it's basically cooking a steak it just dies and and that's your your your death related to coagulation necrosis so with our FA

what's important to know is that the molecules immediately next to the probe are what heat up and then everything from there on out heats sort of by passive conduction and I'll describe how microwave works and that's different to

that but the probe tip never gets hot but the molecules immediately adjacent to the probe get hot and and everything propagates from there on out why is that important well it's important because if you rapidly heat the tissue with RFA

you're gonna get charring but some of you might have experienced this when you do the cases the tissue basically gets charred then it increases the the impedance or the ability to conduct it in which case you you limit your ability

to create an ablation all right so charring is a problem and it increases your impedance which is essentially the resistance to making an ablation cavity and then that decreases the ablation size and so that's really

one of the main reasons why people started moving away from RFA is that you really need tissue that's going to conduct this electrical current well and it's difficult to predict what tissue that's gonna be and so the goal with RFA

as with any other thermal ablation is to get the tissue temperature to between 50 and 100 degrees Celsius and then slow temperature rises are best right so however you want to achieve that slow temperature rise you want to do it

slowly rather than a rapid increase which is the opposite really of microwave ablation radiofrequency

so nursing research goals that we were accomplishing with this research is we wanted to see how radiology nurses could

impact satisfaction with actual implanted venous access ports we also wanted to look at what education if they were having decreasing activities or it was a potential disruption with port placement we wanted to know how we could

influence and make the satisfaction more improved so the purpose of a research study was to explore the effects of the port location on patients experiencing any sort of disruption but we're looking mainly at the 30-day post procedure the

primary questions that we were looking at was how did they feel about their port what was the port location to have any sort of impact and in their activities of daily living but also if they had which side if they had decided

would they choose that site again so depending on clinically if they had to have the port in the left or the right did it function well for them and would they have the same port the same side again

so our population and inclusion and exclusion criteria included we only enrolled 50 patients in this study mainly we had a mixture of males and females mostly females but the age we wanted to

make sure that they were active so we chose ages of active individuals between the ages of 18 and 60 again we mostly had females enrolled but we had a good proportion of males as well the exclusion criteria what we wanted what

we were doing here as many of the background studies that we reviewed showed infection as a concern so we wanted to eliminate anyone that had a current infection and a history of line infection we didn't want to enroll

anyone that had more than three ports and any purse of any previous intolerance of a port at all they didn't like the previous port so we knew that satisfaction rates with any of these items were probably going to show

decrease in satisfaction so we were trying to sort of eliminate that possibility so when we look at the methodology the patient's responded to a questionnaire 30 days post procedure the questionnaires were actually completed

by our ir nurses by telephone we recorded those conversations the patients knew they were being recorded but we wanted to make sure that they were being recorded for accuracy so we can make sure that we got the

information correct some of the background as many of you know that you get a port because you're you have some sort of chronic or malignant disease that's requiring you to get some long term therapy much of that could be

chemotherapy hyper element ation whatever the issue is you need something long-term and for those of you have taken care of cancer patients in the past Lourdes you would presently having just a routine IV it really gets old

really quick and they're very they become very hard your access becomes very hard and patients start complaining of pain at those sites so ports are necessary for many patients multiple studies that we looked at

initially before proceeding to do the study really looked at complications they looked at the technical aspect of how the port was inserted and also the risk associated with placing a port so research is really limited that we saw

that just really only looked exclusively at patient satisfaction scores so we did some chart abstraction obviously to look at patients ages their gender where the port was located what their disease is because that becomes important and also

what's the estimated length of therapy so our questions we focused on comfort discomfort we looked at did it interfere with their ADL's meaning bathing brushing their teeth those type of things and then did it bother with

physical activity so lifting a child running exercising those type of things and then how did they feel about you know what did their port look like and how they felt about it did it influence anything and then did they have to make

changes to their daily activities were they happy with the way that the port looked were they satisfied with where we placed their port and if they had to do it again would they at the same location so here is our results so our findings

suggest that ports the port location when you're looking at those three areas of port location it did not influence satisfaction so how a port looks the port location and if they would choose a different site really didn't influence

whether or not that they were satisfied with the port but what was interesting and what continues to be interesting I'm hoping to have a follow-up study is that 92% were happy with the way that the port looked 96 were satisfied with the

location they would choose the same location again here's where it decreases because I think that fundamentally when you look at the different diagnosis you have more complications with ports on the left

than you do the right so I think that diagnosis comes into the play and port location does have some effect but when you roll all three of those together it wasn't significant and then did patients complain that the port bothered them

with physical activity we had 24 percent of our patients said that it did and then we wanted to see because we wanted an intervention of showing the patients the port we wanted to see how many of our nurses could do that currently in

current practice and we had 66% of those patients were shown the port prior to procedure so the secondary findings kind of drilling down just a little bit more patients who were shown the procedure shown the port pre procedure were more

likely to be satisfied with the port location and we think that that's because it's probably attributing to decreasing the patient's anxiety patients come in all nervous they don't they know that they're getting some

device and planted in their body they don't know exactly what that looks and feels like and just showing them that could potentially decrease their anxiety and raise the satisfaction score and it was positive for us so patients who

complained of pain in our study there was 52 percent of those a complained of pain of those the majority were females the diagnosis categories in which we saw the most pain complaints were in the breast diagnosis group and also the GYN

cancer disorders for males it was 80 percent of those were gastric and we didn't have a lot of males that complained of pain but it's interesting that of those that did all you know all but one were in the gastric disorders so

when we looked at other studies this particular study evaluated satisfaction and in impairments with ADL's of outpatients just like we did now their cohort was a little bit bigger so you have 202 patients all were receiving

chemotherapy with the mean and implantation time of nine months now ours was thirty days when we were calling these patients so 67 of those had complications a third of those had

intolerance had some intolerance with their activities of daily living but when you look at the overall satisfaction score it's high why is it high because they know that if they didn't have this poured chemotherapy

would be a lot worse for them so I think you see this high satisfaction is really related to the port improving as it indicates the experience with chemotherapy but it does go down a little bit you know when you start

looking at would they choose a port again so some of that satisfaction it could be related to some of those complications so with a third reporting interference and 67 complications you can see that some satisfaction will go

down the next study looked at cancer patients in Japan and those cancer patients were refusing to have a port implanted and so the study wanted to know the experiences of the patients before and after the implantation here

you have a questionnaire again you have the same size cohort that we had but here 70% of the patient population was over the age of 60 where ours was below so what I find interesting is I don't think age matters in this category at

all because 96% were satisfied with the port placement so 96% predominantly what we had in our small study as well 44 reported anxiety so again we're seeing anxiety as a contributor and then 14 percent reported discomfort and

problems related to say seatbelt use so some activities of daily living were affected in this study as well so the next study that we looked at was just technical success meaning did they put the port in correctly you know was there

any complications what did they see after the port was implanted this is a retrospective review of a large number of patients 17 over 1700 so of those they had a ninety-nine point two five percent success rate with

no major complications but they did I mean they had a lot of catheter days as you can see and but they had 230 excuse me 243 complications so it's significant for patients who are getting these ports and as you can see 8 percent

of them had to be remote so this particular study looked at access factors as well but then did it predict complications in patient satisfaction now that for those of you who don't know what the TI VAP is it's trans

implantable venous access port so same thing just different way of looking at it so with this with this cohort 561 ports were placed of the 550 patients so some of these patients got an additional port but again high satisfaction rates

you still see the complications and eighty-one of these were receiving chemotherapy so what's interesting about this is again that left side port shows up so they in their conclusion of their study related left-sided port and also a

BM live greater than twenty eight point seven had higher rates of complications in their study so overall when you're looking at the factors across all of these studies and our study you come up with kind of three some central themes

here so even though the satisfaction is greater than ninety percent in all those studies anxiety discomfort and complications really play a significant role for nurses and for those patients right so we're there at the bedside with

them we're there in the procedure room and what can we do to help with that so for the study implications and considerations that we found with this study anxiety is a driver with these patient

they don't know what's gonna happen they're gonna get chemotherapy some long-term therapy whether it's antibiotic how hyper element ation whatever they're nervous about it so giving them support measures on what

that may be like ping control not only a discharge but also pre procedure intra procedure and post procedure and Steve will talk a little bit about that here shortly and what kind of education do we need to give these people so this

may be the first time they're in a medical center so what are we giving what what kind of education are we giving them to take home with them so I think it's important that if there's disruption and ADL's that we prepare

those patients for providing an opportunity to see the port we could clearly see the p-value here showed that there was a positive correlation between satisfaction and seeing that port so being able to take that port and let

those patients feel it see it may help with with that with that driver of decreasing the anxiety and then infection prevention you saw the studies we didn't include infection in ours because the evidence is overwhelming for

complications and infections so anytime that you have an infection you have pain and so we did not include that but that is something that we feel that from a clinical indication that nursing in radiology nurses should consider giving

information on Steve thank you to

where the rubber hits the road is how we and what we do with this and the first

entity that we started treating with skyla thorax and what kyla thorax is basically a milky pleural effusion you guys I'm sure I've seen this you're doing a thoracentesis on a the food that comes out actually pretty

thick it's not clear it's almost this milky color the patients are usually fairly ill they've had Safa geo surgery lung cancer surgery heart surgery etc we test the fluids for triglycerides and chylomicrons and if that's positive then

we know it's a kind of thorax historically these patients would be treated by not being fed given TPN and maybe octreotide they'd maybe go to surgery if they received no treatment they had 50% of them died six to 12

weeks later if they went to surgery 12 percent of them died if they went to surgery 40% of them had major complications so you can see if this was a major opportunity for us to step in and really change the outcome for these

patients as I said Constantine Koch did the first procedures on this but I'll show you what it looks like this is doing a central and fangy Graham and we're serial images you see that leak accumulating on the right side the

right pleural space we have our wire and catheter in all ready and all we're gonna do is we're gonna start coiling up at the area across the leak and put more coils and a little bit of glue at the end when we do that we have a very high

success rate you see four major studies that have been published from 2004 to the present you see the first ones doctor copes major study 42 patients from UPenn the second one is also from UPenn 109 patients the next ones from my

Hospital Brigham and Women's where I did my training and then the last ones from Pittsburgh there have been subsequent studies as well but this included over 400 patients between these there was a meta-analysis in jvi our last year

showing that the lymphatic interventions for Kyle thorax pretty successful looking even at old technology that were used for the embolization zhh 400 patients nine studies 80% success rate across all these different centers I

would say in experienced hands a success rate exceeds 95% for traumatic Kyllo thorax at the present so we know that this is a pretty respectable for the treatment of Kyle of thorax a CR has some guidelines out for how the thorax

treatment as well encourage you to take a look at them it can break it down between traumatic and non traumatic caudal thorax and gives you some recommendations of how to approach it

pediatric catholic's is a little bit slower to treat generally everything in peds is a little bit slow to be adopted we obviously want to be very careful with our most vulnerable patients so the types of disorders that pediatric

patients are slightly different because they can have congenital or idiopathic I authorities it can be from lymphatic malformations or from different syndromes it certainly be from congenital heart surgeries and other

issues that they may have going on there have been several reports published at our institution University of Michigan we publish the largest cohort of pediatric patients and it was only eleven but ultimately we showed that

thoracic duct embolization was just as effective just as safe in this population our youngest kid was only two weeks old our smallest kid was two kilograms so a very vulnerable very small structures but you can still do

and still have fantastic outcomes for

another device that's new in the market

is the inari device it is a combi combination of suction thrombectomy and mechanical thrombectomy and it you can see it looks like three Amplatz or plugs on a catheter but that blue catheter is actually a very nice suction system as

well so you can go beyond the clot pull it in and then suck it into the catheter this is very useful because you can pull clot out without giving any TPA and you have a lot less blood loss so if you can take the clot out with a lot less blood

loss I think you can out patients again the benefit is that there's no thrombolytic and the patients have less bleeding drawbacks like many of these devices is there's really no studies to prove that they work we can prove that

they can remove clot from the patient's body but that we don't know that that actually helps in the long run so what we really want to know in all the studies which we're actually going to show three of the main studies is

whether this actually helps patients life in the long term do they does it improve their mortality so the first

designed a u.s. clinical study we got an investigational device exemption

actually Julie's our clinical research coordinator for this study and these are the inclusion exclusion criteria we basically excluded patients who have rheumatoid arthritis previous surgery and you had to have moderate or severe

pain so greater than 50 means basically greater than 5 out of 10 on a pain scale we use a pain scale of 0 to 100 because it allows you to delineate pain a little bit better and you had to be refractory to something so you had to fail

medications injections radiofrequency ablation you had to fail some other treatment we followed these patients for 6 months and we got x-rays and MRIs before and then we got MRIs at one month to assess for if there was any

non-target embolization likes a bone infarct after this procedure these are the clinical scales we use to assess are not really so important as much as it is we're trying to track pain and we're trying to check disability so one is the

VA s or visual analog score and on the right is the whoa max scale so patients fill this out you can assess how disabled they are from their knee pain it assesses their function their stiffness and their pain

it's a little bit limiting because of course most patients have bilateral knee pain so in trying to assess someone's function and you've improved one knee sometimes them walking up a flight of stairs may not improve significantly but

their pain may improve significantly in that knee when we did our patients these were the baseline demographics in our patients the average age was 65 and you see here the average BMI in our patients is 35 so this is on board or class 1

class 2 obesity if you look at the Japanese study the BMI in that patient that doctor okano had published the average BMI and their patient population was 25 so it gives you a big difference in the patient population we're treating

and that may impact the results how do we actually do the procedure so we palpate the knee and we feel for where the pain is so that's why we have these blue circles on there so we basically palpate the knee and figure

out is the pain medial lateral superior inferior and then we target those two Nicollet arteries and as depicted on this image there are basically 6 to Nicollet arteries that we look for 3 on the medial side 3 on the lateral side

once we know where they have pain we only go there so we're not going to treat the whole knee so people come in and say my home knee hurts they're not really going to be a good candidate for this procedure you want focal synovitis

or inflammation which is what we're looking for and most people have medial and Lee pain but there are a small subset of patients of lateral pain so this is an example patient from our study says patient had an MRI beforehand

and you can see on this t1-weighted image that increased area of enhancement which is the area of synovial thickening you actually see this on MRI beforehand and there it is located over the lateral aspect of the knee on the axial image

and so what we're doing sorry in the medial aspect of the knee so what we're doing here on the angiogram is and you solve these leg angiograms where everyone doesn't really care about these you Nicollet arteries they're really

important when you have SMA or popliteal occlusive disease because they serve as a collateral source but otherwise and people have arthritis they can be a real pain and the pain in the knee if you will so this is a this is the superior

medial geniculate artery and always drapes over the femoral condyle and you'll see here on this image you don't really see very much but once we get into the vessel look at this it almost looks like a small about a cellular

carcinoma like when you're in the liver you get this tumor type blush vascularity that's what we're looking for that corresponds to the patient's area of pain and then after embolization this is what it looks like takes a very

small embolic we're using maybe point four two point six sometimes one CC at most of dilute embolic that we're injecting this is another case again before and after if you look here on the right and then

on the left you don't really see much until you select the vessel out once you get into that super medial vessel you can see how much enhancement there is so in our clinical study of twenty patients this is what we did you'll see on the

bottom here we used embassy and 75 micron in nine patients and eleven eleven patients got a hundred micron and I'll explain why we upsized our particles so initially we wanted to go very small because that's where dr. o

Cano had done in Japan but then we wanted to actually up size our particles and I'll explain this here in our complications so like all clinical studies the purpose of doing really good clinical research is because this is

early and we don't know if they're going to be complications and it's always fun when you're the first one to figure it out and you tell patients I don't really know what's gonna happen and this is what happens so thirteen patients had

this kind of skin discoloration over their knee now we knew this because we've been doing the embolization for about ten years in bleeding patients not necessarily arthritic patients so we had seen this before but none of these

patients in this clinical study went on to have any alteration of the skin and it resolved in all patients there was some minor side effects from basically medications and one small groin hematoma but there were two patients who

developed plantar numbness over their great toe so under their great toe basically the medial distribution of their tibial nerve they ended up getting plantar numbness and this is believed at least in our experience to probably be

related to non-target embolization to the tibial nerve the tibial nerve probably gets its blood supply from many of these Jamaican arteries so we decided after having these two cases one at our institution and one at University of

North Carolina Chapel Hill that we would then basically upsize our particles to 100 micron and we have not seen that and we're doing a second clinical study and I'm not seeing that he's either we had about a 70% reduction in pain so if you

look at our visual analog score out to six months and if you look at our disability it actually paralleled this exactly which is pretty impressive considering mostly patients had bilateral knee pain so out to six months

very good results 90% of patients were responders so two out of our twenty patients did not really respond one patient didn't respond at his one month follow-up but did wrist that is three and six so I still

consider them a clinical failure because we expect these patients to respond by one month here's just an example of a baseline MRI before and after and you can see all that joint effusion there the white that decreases just even after

a month how much it decreases and we looked at this in terms of synovial thickness and distension and even on MRI you can objectively count calculate synovitis scores and we calculated that they actually statistically decreased

this is another patient on the left the image shows diffuse white enhancement if you will of the synovium of the lining on the right it shows the fluid this is an image just of embolization and I show this image because it's really shocking

and this is actually one of our nurses who's enrolled in the clinical study is this is before this is all we did we embolized the medial aspect of the knee this is one month later 30 days in fact somebody just asked me this when I was

in the booth over at the meeting across the street and basically I said listen I don't know why this happened so quickly I have no idea we didn't tap her knee we didn't do anything else if you look at this premium post it's pretty dramatic

so clearly there's an inflammatory process that we are arresting or stopping in such a short period of time so is there a future for this I don't know it may just we may just fall down and find out that there really is in a

great future but so far we know it's at least technically successful it's the results are positive in the short term long term we're not so sure yet we do need to better understand these risks and I think in my opinion in the long

term it'll probably really really good for this 40 to 65 year old patient population who's not yet ready for knee replacement surgery this is the algorithm for our clinical study which were almost done enrolling right now

it's a randomized control study against placebo so it's two to one randomization which means one third of the patients actually get a sham procedure so we do an angiogram on their leg they're asleep they have no idea for embolizing there -

Nicola arteries are not we wake them up and they get off the table and we follow them up if they're no better they're allowed to cross over and get the treatment the other 2/3 of the patient actually get the treatment and they

don't know either if they got the treatment and then we follow these patients when we assess if you if they have improvement all pain mediated procedures must undergo sham controlled studies because pain is so right in it's

so intuitive to just yourself so you can't really if there's a placebo effect so this is why pussy bow control studies are very important I believe we have one more patient left to enroll in this clinical

study and then we should be done with that so I'll switch gears really quick

questions comments and accusations please hello this topic is very personal to me I've had it actually had a UFE so this is like one of my big things I work in the outpatient center as well as a

hospital where we perform you Effy's and frequently the radiologist will have me go in and talk to the patient it's from a personal perspective one of the issues which it may just have been from my situation was pain control post UFE

whether you normally tell your patients about pain control after the UFE someone say we are all struggling with this yeah oh it's not what's your question is going to be okay good I'm gonna get doctor Dora to answer Shawn the question

is what do you what do we do with this pain issue you know what are you doing for the home there at Emory there you know and a lot of practices we we don't rely on one magic bullet for pain control recently we've been doing

alternate procedures for two adjunctive procedures to help with pain control for example there are nerve blocks that you can do like a superior hypogastric nerve block there's there's Tylenol that can be given intravenously which is seems to

be a little more effective than by mouth there's there's a you know it and a lot of times it's it's a delicate balance right between pain post procedural pain because you can often get the pain well controlled with with narcotics opioid

with a pain pump but the problem is 12 hours later the patients is extremely nauseous and that's what keeps her in the hospital so it's a it's a balance between pain control and nausea you can you can hit the nausea

beforehand using a pain and scopolamine patch that that'll get built up in the system during the procedure and that kind of obviates the nausea issues like I said that the the nerve blocks the the tile and also there are some other

medicines that can can be used adjunctive leaf or for pain control in addition to to the to the opioids so the answer the question is there are multiple there multiple answers to the question there's not one magic bullet so

that helped it did one of the things that I tell the patients is that you know everyone is different and yet some people I've seen patients come out and they have no pain they're like perfect and then some come out and they are

writhing in the bed and they're hurting and they're rolling all around what and I always ask the acid docs are you telling them they could possibly have you know pain after the procedure because some have the expectation that

I'm going to be pain-free and that's not always the case so they have an unrealistic expectation that I'm gonna have the UFE but not have pain what I also tell them is that the pain it's kind of like an investment right and

this is easy for a guy to say that right but but it's it's an investment the worst part the worst pain you should be feeling is the first 12 12 hours or so every day I tell my patient you're gonna be getting better and better and better

with far as the pain as long as you is you follow our little cookbook of medicines that we give you on the way home and I want you to make sure that you fill these prescriptions on the way home or you have someone fill those

prescriptions for you before he or she picked you up in the hospital and lately we have been and I see that you're there as well lots of other little tricks that are out there right and again there are all

little tricks so ensure arterial lidocaine doctor there is near alluded to and if you're on si R Connect you may it may spill over on some of your chat rooms here people have been using like muscle relaxant like flexural or

robertson with some success but just know that we don't have any studies that tell us how that's supposed to do so when i have someone that is like writhing in pain i just use everything so i do it superior hypogastric nerve

vlog and i actually will do some intra-arterial lidocaine although not so much lately i have been using the muscle relaxant but i will warn you that i've had two patients with extreme anticholinergic effects where they are

now not able to pee from that so you know where we're doing that balance act I see that you're there can I take that question here first just so we're we're doing the same thing we're using the multimodal just throwing all these

things at people and we're trying the superior hypogastric blocks but we're collaborating with anesthesia to do that right now do you all do your own blocks or do you collaborate with anesthesia we do our own blocks okay it isn't it is

not that difficult I would tell you that but again it's kind of like you know you got to do if you start feeling better and then you're like we don't really need them we'll just do it on our own okay thank you again yes what's the

acceptable interval between UFE and for IBF oh that's a your question what is the interval between UFE and IVF so if you wanted to get pregnant yeah and can you have a you Fe and then have an IVF like how long would you have to wait

wait and tell you before you can have that the IBF it I guess it really depends on the age of the patient because we know that that the threshold for which patient tend to have that inability to conceive

is around 45 years old so you know it did below the you know below the age of 45 the risk of causing ovarian failure or or the inability to conceive is significantly less it's zero zero to three percent so I would say that you

know you probably want the effects of the fibroid embolization to two to take effect it takes around 12 months for these fibroids to shrink down to their most weight that they're gonna they're going to shrink down the most I wouldn't

say you need to wait 12 months to put our nine vitro fertilization there's no good there's no good literature out there I don't believe that's your next and so I would say just remember that if you came to my practice and you said you

wanted to get pregnant I will be sending you to talk to fertility specialists beforehand we do not perform embolization procedures as a way to become pregnant there's no data to support that but if you saw your

gynecologist and they said let's do this then I'm sure they'll be doing lots of adjunct things to figure out what would be an ideal time then to for you to have IVF and if I dove not having any data to inform me I would ask you to wait a year

and what will be the effect of those hormones that they gave you if for example a patient has existing fibroids what would be the effect of those hormones that IVF doctors prescribed their patients yeah so fibroids actually

can grow during pregnancy so I would say that most of those hormones are pro fertility hormones so I would expect that maybe you can see some of that effect as well yeah alright if you have any other questions you can grab me oh

you're I'm sorry go with it okay yes we we have time I don't want to keep anybody here for that so I have a two-fold question the first one is post-procedure can you use a diclofenac patch or a 12-hour pain

patch that is a an NSAID have you have any experience with that and your next question my second part of the question is there a patient profile or a psychological profile that tips you that the patient is not going to be able to

candidate because of their issues around pain so they're two separate but we have in success sending people home that first day so I'm looking to just make it better I haven't had experience with the Clos

phonetic patch it's in theory it seems ok you know these are all the these are they're all these are non-steroidal anti-inflammatory drugs so there are different potency levels for all of them they you know they range from very low

with with naproxen to to a little bit higher with toradol like that clover neck I think is somewhere in between so we found that at least I found that that q6 our our tour at all it tends to help a lot so with that said I I don't have

much experience with it with the patch in answer to your second question the only thing I can say is there there is a strong correlation between size of fibroids and the the amount of a post procedural pain and post embolization

syndrome so there really you know we often say we don't really care too much about the number of fibroids but the size of the fibroid is is is should be you know you should you should look at that on pre procedural imaging because

if it gets too big it may not be worth it for the patient because they may be in severe pain the more embolic you put into the blood supply's applying the the fibroid the the greater the pain post procedural pain

are there multiple other factors that would contribute to pain but that's that's one aspect you can you can look at post procedurally on imaging okay thank you very much yes ma'am hi what what kind of catheter do you use

to catheterize the fibroid artery when you pass by radio access yeah so over the last three years the companies have been really very good about that so there are a few things that I without endorsing one company or the other that

you need to make sure that the sheath that you're using is one of those radial sheets a company that makes a radio sheath you should not use a femoral sheath for radial access so no cheating where that's concern you may get away

with it once or twice but it will catch up to you and you need a catheter that is long enough to go from the radio to the to the groin so I'm looking for like a 120 or 125 centimeter kind of angled catheter whether it's hydrophilic the

whole way or just a hydrophilic tip or not at all you can you can choose which one in our practice most of us still tend to use a micro catheter through that catheter although if I'm using a for French and good glide calf and it

just flips into like a nice big juicy uterine artery then I may just go ahead and take that and do the embolization if the fellow is not scrubbed in as well so thanks a lot but they make they make many different kinds like that and more

of those are to come all right I'm you can please please please send us any other questions that you have thanks for your time and attention and enjoy the rest of the living

next is me talking about Egypt and Ethiopia and how I are how IRS practice in Egypt and Ethiopia and I think feather and Musti is gonna talk a little bit about Ethiopia as well he's got a

lot of experience about in about Ethiopia I chose these two countries to show you the kind of the the the the difference between different countries with within Africa Egypt is the 20th economy worldwide by GDP third largest

economy in Africa by some estimates the largest economy in Africa it's about a hundred million people about a little-little and about thirty percent of the population in the u.s. 15 florist's population worldwide and has

about a little over a hundred ir's right now 15 years ago they had less than ten IRS and fifteen years ago they had maybe two to three IRS at a hundred percent nowadays they're exceeding a hundred IRS so tremendous gross in the last 15 years

in the other hand Ethiopia is a very similar sized country but they only have three to five IRS that are not a hundred percent IRS and are still many of them are under training so there are major differences between countries within

within Africa countries that still need a lot of help and a lot of growth and countries that are like ten fifteen years ahead as far as as far as intervention ready intervention radiology

most of the practice in Ethiopia are basic biopsies drainages and vascular access but there is new workshops with with embolization as well as well as well as vascular access in Egypt the the ir practice is heavily into

interventional oncology and cancer that's the bulk that's the bulk of their of their practices you also get very strong neuro intervention radiology and that's mostly most of these are French trained and not

American trains so they're the neuro IRS in Egypt or heavily French and Belgian trains with with french-speaking influence but the bulk of the body iron that's not neuro is mostly cancer and it involves y9e tastes ablations high-end

ablations there's no cryoablation in Egypt there is high-end like like a nano knife reverse electric race electroporation in Egypt as well but there is no cryo you also get a specialty embolization such as fibroids

prostate and embroiders are big in Egypt they're growing very very rapidly especially prostates hemorrhoids and fibroids is an older one but it's still there's still a lot of growth for fibroid embolization zyou FES in Egypt

there's some portal portal intervention there's a lot of need for that but not a lot of IRS are actually doing portal intervention and then there's nonvascular such as billary gu there's also vascular access a lot of

the vascular access is actually done by nephrology and is not done by not not done by r is done by some high RS varicose veins done by vascular surgery and done by IRS as an outpatient there's a lot of visceral angiography as well

renal and transplants stuff so it's pretty high ends they do not do P ad very few IR s and maybe probably two IR s in the country that actually do P ad the the rest of the P ad is actually endovascular PA DS done by vascular

surgery a Horta is done all by vascular surgery and cardiothoracic surgery it's not done it's not done by IR IR s are asked just to help with embolization sometimes help with trying to get a catheter in a certain area but it's

really run by by vascular surgeons but but most more or less it's it's the whole gamut and I'm going to give you a little example of how things are different that when it comes to a Kannamma 'kz there's no dialysis work

they don't do Pfister grams they don't do D clots the reason for that is the vascular surgeons are actually very good at establishing fishless and they usually don't have a

lot of problems with it sometimes if the fistula is from Beau's door narrowed it's surgically revised they do a surgical thrombectomy because it's a lot cheaper it's a lot cheaper than balloons sheaths and and trying to and try a TPA

is very expensive it's a lot cheaper for a surgeon to just clean it out surgically and resuture it there's no there's no inventory there are no expensive consumables so we don't see dialysis as far as fistula or dialysis

conduits at all in Egypt and that's usually a trend in developed in developed countries next we'll talk

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

peripheral artery disease affects up to 12 million peopl amputations occur yearly do a peripheral artery disease specifically critical

limb ischemia that is almost certainly way more than should be done up to two million people have critical limb ischemia so how do patients present when they have PA d in general okay there's really one of two presentations general

categories the first thing is intermittent claudication so Claude occation means I walk and I get pain okay when I stop walking the pain goes away you also have critical limb ischemia

which we call CLI CLI is such severe peripheral artery disease that you actually a foot and leg pain at rest in other words your blood flow is so bad that even at rest you don't have enough perfusion to go to

your foot and you have a scheming pain or your blood flow is so bad that you can't heal a sore or an ulcer okay so forget walking these are the this is the most severe form of peripheral artery disease

okay so again Kumar mentioned this before peripheral artery disease is like a highway if you and I say this a million times a day my pas are so sick of hearing it if you block a highway traffic can't get through and so it has

to go through detours when you go through detours you're always slower things are never as efficient and you back up that's exactly what happens here plaque builds up in the artery blood flow can't get through and so you can't

get to where you're going there's the highway analogy a key point and again I hear this all the time you know the patient came in with a wound but it's weird they never had claudication so maybe this isn't arterial wrong

intermittent claudication does not need to come before critical limb ischemia in other words many patients their first presentation is critical of ischemia so they'll never know that PA D they never have what you know pain when they walk

their first presentation is a potentially severe morbid and mortal one so what are the risks factors for PID it's everything we think about smoking obviously is a big one high blood pressure cholesterol diabetes obesity

physical activity well there's other risk factors family history and age so my question is what's the difference between these two risk factors what there's been these risk factors and these risk factors

one is changeable the other is not as much as we try with Botox or Juvederm or whatever it is we can't change our age and as much as we try we can't change our family history but we can change smoking and cholesterol and do all the

things that we can do and it's not easy but it can be done I will say a special

primary Africa cm point 86% matured remember what do we say before you know not what 96% so that's the answer to the surgeons why surgeon says why should I do this why don't I just create official

it takes me 20 minutes there's no surgeon in the world who can create a fistula that's gonna mature 86 percent of the time I don't that's not happening all right the endpoints were met secondary

endpoints to needle dialysis 88% I mean that just doesn't happen surgically I'm sorry and I'll show you some other data as well where the superiority of the percutaneous fistula over surgery this is the jvi are pivotal trial I with Jeff

Hall and tip Jennings and here's the match of the secondary maturation procedures that had to be done all right some get an estimate and we angioplasty the anastomosis embolization of branches an angioplasty Stan's oh okay

here's the bar device and this is called the ever linked queue back in these six French days and now wave link device there are two catheters one goes into the brachial artery one goes into a brachial vein there's a big magnets this

is the six wrench device and you can see that little connection I hope you can that's a foot foot plate a little electrode that pops up between the two catheters it actually creates the official of this time with a

radiofrequency energy on the right you see a brachial artery angiogram and the point of official creation with six ranch was the common on our branch which you can see down there below you have the big dense radial artery coming up on

top and then you see the common arm branch and then the proper ol arm going down there at four o'clock and then the interosseous in the middle now with the the four french device you can create fistulas from the

radial vein to radial artery or radial arterial vein owner artery to ulnar vein and either one gives you a little more options about where you want to create well why would you want options well if you go down to the video of vena Graham

in the and the ulna vein and you don't see any flow up the the perforator well you can only switch to the other side and to try to find better flow put yourself in a better position to create a working fistula this does use

ultrasound to puncture but then uses fluoroscopy to position the devices its RF energy has a little bit of a problem with heavily calcified vessels who's ever seen that and in dialysis patient right so and because radiofrequency

energy goes around calcium it doesn't go through we've had one case where we did there was just no fistula creation everything went finally since no fistula and so that patient got a surgical fistula multiple angles to confirm

correct position of the device this was with the six french device the four french device is much less cumbersome because you want to make sure that that footplate that I showed you sits directly in the receiver area to create

otherwise if you go off to the side left and right they you can have a problem with creating pseudoaneurysm some things no angioplasty then ask to most us however in this case you do embolize on the way out because you've entered the

brachial vein and you embolize form just to stop any losing and to because you want to help to redirect flow towards the superficial system here are the two devices on the left into the four frames versus the six

range quite a difference much more easy to work with the four french doesn't have a bulky handle on the end like the six ranch did they're pretty easy to position and it's a a round electrode not a foot that comes up and it kind of

sits in what they call the saddle you can see there where it says square magnets underfloor french there's a saddle there that that loop electrode sits in and very easy in there to position

who's a candidate well doctor Ross says

here are the treatment options and I did want to include a fourth one it says nothing about the intervention per se but it's medical management which was actually had the significant growth over the last decade and really more

aggressive medical management every treatment below this should have medical management included as part of it so I included that first that's critical if you're gonna have a carotid endarterectomy if that's what ultimately

your your physician decides then you should still have medical management before and after carotid artery stenting and then ultimately trans carotid artery stenting so carotid endarterectomy I'll show you a case example but this is a

diagram illustrating what's ultimately done that longitudinal incision and then removal of that plaque this is what the plaque looks like when it comes out as opposed to carotid artery stenting which is less invasive obviously and we place

a stent but we don't actually remove the plaque overall you know you know we can talk about why that's okay in fact the plaque itself doesn't need to come up what we need to improve the flow and stabilize that plaque from being able to

embolize small clot overall medical therapy is really just these basic things aspirin or sometimes dual antiplatelet therapy so that's aspirin and plavix in addition aggressive statin therapy so

Doc's will Vascular Docs anyone interested in this space will have you a non-aggressive statins or cholesterol-lowering medications stop smoking tight glucose control so those diabetics have to be really well

regulated and in the blood pressure control if you don't do those things no matter what you do with the carotid endarterectomy or the stenting is gonna fail so what's carotid endarterectomy

of critical of ischemia well a lot of times it starts in our office with a physical examination so we do a risk

factor assessment and this is what happens before they get on our table with with everyone in this room and us seeing the patient assessment of intermittent claudication and it can be subtle many patients don't come in and

say oh yeah I have pain when I walk for a short time and then it I rest and it goes away a lot of times it's yeah you know my leg gives out or now it doesn't hurt it's kind of this weird feeling when I walk and it these atypical

symptoms and then obviously if they have a wound you have to a wound evaluation on physical examination things we're looking for feeling a pulse you'll be surprised how many primary care providers never feel a pulse and if we

say if you feel a pulse you may save a life because you may be the first one to say hey this patient doesn't have a pulse maybe they have got peripheral artery disease and if they prefer order these maybe have coronary artery disease

and maybe they should we start on aspirin or statin and save them from a heart attack and stroke and so you really can save a life abnormal capillary refill so in other words you've got such bad blood flow

that if you smush on their foot it takes a long time for that blood to come back because they have such poor perfusion there's something a Peugeot stess TWEN that if you lift their leg gravity alone pushes their blood isn't it overcomes

the force of blood and so there are foot becomes power becomes losing some color and then when you put them down it dilates and you get sort of this ruborous red color so that's a burger sign I just had a good example in clinic

about a week or two ago so what do we ask for patients do of any pain or discomfort in the leg thigh or butt with walking your exercise I will sell you tell you I often don't use the word pain because everyone thinks pain is

different so so some people say well it's not paying it's a key lake ease pain to me I'm a guy everything's pain to me right low low threshold but discomfort is a good way of asking it foot or toe pain

that disturbs your sleep do you have any skin ulcers or sores on your ankles feet or toes I think it's very important to know what kind of patient you're talking to in terms of Education level or in terms of just language so some patients

don't know what it all sir is and they use the term sore some people don't know what a sore is they used term wound and so just sort of you ask things different ways I think is really important when we all talk to our patients and again a lot

of classic history will miss a large majority of PAE because patients don't read the textbook the one thing I'll say is I hear this all the time well the patient had pulses and so they don't have P ad that is hashtag false and the

reason is pulse exam is insensitive so in other words even if you feel pulses they can still have peripheral artery disease okay now if you don't feel pulses they certainly have peripheral artery disease or you're just terrible

at it PID classification the way we talk about patients with PA D we use a classification scale called Rutherford it may come up so in other words patient who has PA D but asymptomatic is

Rutherford zero a patient who has got major tissue loss and is basically 1 for amputation is Rutherford 6 and then everything in between is sort of a gradation we cut off 3 to 4 so 3 is claudication pain only 4 is critical in

ischemia rest pain alright so rather for classification when we talk about wounds you may see this you don't need to go in details but there's a Wi-Fi classification that sort of Germans how bad is the ulcer and how likely are you

to to lose your leg it's sort of a prognostic I will remind you that in medicine there's differentials for everything in other words the patient comes to you with pain or you talk to your friend or whatever with pain

there's a lot of things in cause pain it could be back pain arthritis infection DVT so there's things we have to think about when I was in medical school I sort of loved this my OB GaN professor said when he sees a patient the first

thing he does is say what do I think this patient have if this were a man because you get so pigeon-holed in your specialty every patient we see as well must be vas here must be vas care but you've got to take a step back and say

okay well am I missing something maybe it's arthritis may something else so don't get pigeonholed by your own prejudices which is a good life lesson in general there's also a differential for wounds so obviously

when we see a wound we could have arterial arterial tends to be sort of the toes and distal foot it can be severe pain if you see an ulcer around the ankle that tends to be more venous so vein related which again we

can treat and then a common cause is neuropathic so if you see I'm sort of at the pressure points where people walk a lot of times patient diabetes will step on something and where you and I would be like oh man that hurts

I better oh my god I have a wound there I better check that out they'll never know because they don't feel their feet and so they could have this monster ulcer and finally someone inspects their feet and says you know you have like a

golf ball sized hole in your foot and that's the first time they ever notice it so how do we test ever for peripheral artery disease well a lot of it is non-invasive now we do a B is a b is is a measure of blood pressure in the foot

or leg we can do some ultrasound to actually look at the artery and obviously we can do CT and MRI when we look at ultrasound you may look at this every once a while this is a normal ultrasound Doppler waveform where we've

got good blood flow up down and back three now the reason that's important is that correlates the sounds so if you listen to a artery i'ma do my best Doppler impression out okay a normal artery goes once you start getting

peripheral artery disease you lose that triphasic waveform it becomes biphasic when you get severe peripheral artery disease you lose that biphasic waveform it becomes monophasic and when you have nothing it becomes

okay so here's want to be alert to that so ankle brachial index is important and it's helpful again some patients who have calcific us a-- fication it's not helpful for I will tell you a B eyes alone actually not only do they predict

PA D they predict death that's how important PA D is link to mortality CT and MRI is very useful you can see here we can see a good anatomic description of the arteries unfortunately patients with calcium

sometimes we can't see as well because the calcium is so bright on CT scan that it obscures the lumen so we have other problems in patients with diabetes and heavy calcification and a lot of those patients just need to go to angiogram

and as you know my techs and nurses know sometimes rarely but sometimes we do an angiogram and it's normal and we say or there's mild disease we say okay perfect we've taken that off the table we need to move on when some of these

non-invasive testings aren't as clear so alright so in summary critical of ischemia is a morbid disease and can be the first presentation of PA d clinical suspicion and accurate diagnosis is essential for early diagnosis and

treatment and a multidisciplinary team that includes vascular venture loss who know critical limb ischemia not just the SFA and iliac artery jockeys and wound care specialists do decrease amputation rates I like this quote it's not mine

but I'm going to steal it with impunity amputation is not a treatment option it is a treatment failure okay so we have to keep that in mind I appreciate everyone's attention because we can save questions to the end or you do it now if

there's pressing I think we may need new batteries or my thumb's weak which is also a possibility any questions

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

- [Lu Qingsheng] I have no disclosures. We know for indication of EVAR we need favorable proximal neck anatomy but if it not unfavorable maybe we are some Type 1a endoleak it's a serious complication for EVAR. So for prevent and treat Type 1a endoleak

especial for some juxtarenal aneurysm maybe we use the chimney fenestration branch and some sac bag. Could we find a simple safe cheap and effective method? So we find from open surgery we were introduced this fibrin glue

means its complex of thrombin and fibrinogen, it's used hemostasis in open surgery so we put that into inject that into the sac, we call it fibrin glue sac embolization. I will show you some cases.

For this case is very short neck and not quality of deck and after deploy the stent graft, of course very serious Type 1a endoleak. But fortunately, we put a catheter before we deploy the stent graft so this catheter is into the sac of the aneurysm

then we use up a long controlled blood flow and we inject from the catheter into the sac of the aneurysm and we inject the fibrin glue. And you can find the contrast not moved after we withdraw balloon. Then we do the angiogram.

We find no any endoleak. Another case showed is angulated neck as this patient. Of course after we deployed stent graft have a lot of endoleak. And we do again this technique. And control the balloon, control the blood flow,

then inject the fibrin glue, and we check all that and withdrew the balloon, there are no any movement about the sac. And we do the angiogram and no any endoleak. Till now, we did, we begin this technique 2002, so we follow long time that we can show it's safe.

So till now we treat 156 cases and proximal less then short proximal neck is 75 cases even some of less than 10 millimeters. And angulation more than 60 degree even some cases more than 75 degree.

Most of them more than 98% of patients' endoleak was resolved. And during our follow up, the mean time more than 100 months, only three patients died of aneurysm related sac enlargement.

The mean maxim aneurysm diameter decreased and no recurrent Type 1 endoleak so we have confidence that it's safe and no any sealant-related complication for example renal failure and aplasia other things. So we discuss the mechanism

it's not only embolization for endoleak but also coagulating all sac of aneurysm like this in shows how it worked. And we also measure the pressure in the sac. Intrasac pressure decreased significantly in treated cases. And how about that technique we need occlusion

proximal blood flow and protect branch ateliers and prevent distal embolization. And we also treated into the rupture aneurysm and it can treat any type of endoleak as these cases it's a rupture aneurysm we do the EVAR emergency.

And after we deploy this devices, we find this endoleak. We don't make sure which kind of endoleak but anyway we just do that, control the blood flow use the balloon then inject the fibrin glue in that.

And all the sac of aneurysm. Then we do the angiogram and endoleak disappeared. We'll be treat any type endoleak of the rupture EVAR we prevent rupture post-EVAR and we decreased abdominal compartment syndrome. So the conclusion is

fibrin glue sac embolization is a simple and effective treatment method. And this method could expand the current indication of EVAR. For selective the length maybe can to the 5 millimeters, angle maybe can to the 90 degree,

and for emergency we seen it should be into the older EVARs for rupture aneurysms. Thank you very much.

advantages of radiofrequency ablation or that there's the most research on this

right so if you look up ablation research there's a whole lot of data and research on this as it's been the longest studied so that's always beneficial when you're trying to convince people that they should get an

ablation it's cheap right although some of the problem with that is a lot of manufacturers aren't making some of the devices anymore so to get replacement probes and that sort thing is difficult but it is certainly much cheaper than

the other modalities its gentler than microwave right so it's a slower increase in temperature and you can control it the disadvantages as we mention right so the ablation zone this is probably the worst part about

radiofrequency ablation is that the ablation zone is unpredictable right now we're trying to go towards this idea where we can predict the exact size of the ablation and really with RFA it was more experience related right so if

someone I've been doing them for 20 they can have a good idea how it's gonna it's gonna blade but that ablation zone is very unpredictable it's very tissue dependent right so if you have cirrhosis and the liver is

really scarred down you're gonna get a different ablation as to someone who has a normal appearing liver you have the heatsink effect which as I mentioned can be used as an advantage but usually as a disadvantage and then large large burns

are difficult right so anything greater than 4 centimeters even that is difficult to achieve with RFA it is possible to get skin burns at the grounding pad so if you're gonna do RFA make sure that the patient doesn't have

a hip prosthesis for instance and make sure you know it sometimes patients get sweat underneath the the pads and that can increase skin burns and those pads so that's one of another downside of a radiofrequency ablation so we'll move on

are just a couple examples you know this is a little bit of older data but our uterine fibroid embolization have gone up by 60 percent from when we started to where we are now or filter retrieval

program gone up by 400 percent you know our ablations have gone up by over 50% you know and that's it's not saying that's all because of social media but it's partially because of that because we do get patients that come into our

clinic because of that and then on top of that I'll tag when I'm doing an ablation I'll tag my urologist or I'll tag de aslv you know and then all of a sudden sometimes they like it which pushes it to their followers or they'll

retweet it which directly pushes it to their followers and then in which case you're putting yourself in the consciousness of people that can refer you cases and all of a sudden now you become indispensable in the realm of

ablation at least in my case because everybody sees me posting about it right so everybody in our institution is sending me ablation cases and that's a really great thing for us so you know I

study that was done was the perfect registry so all these studies have some name perfect the PE stands for pulmonary

embolism I don't know what the rest means but it's a registry of a hundred and one consecutive patients so these are patients that had what they termed at that time massive PE as well as sub massive PE it was seven sites and they

took all their data over three years so basically they said if you treated a patient with PE let us know send us all their info we're gonna put it in this one paper the therapy was all over the place for so patients with sub massive

or intermediate high risk PE they got catheter directed thrombolysis usually over 12 to 24 hours but again it was not specific it was whatever they did we want to know about it put it in one and sort of reported patients with

massive PE which are very different from those patients with intermediate high risk PE got mechanical fragmentation with some low-dose TPA and this was left open to whatever you were doing at your institution and then they looked at how

patients did overall and they looked at only survival to hospital discharge so they just want to know if patients like made it through that hospitalization overall they found that most patients were treated successfully so they didn't

die on the on the table and that they were able to get through there were six deaths for four mostly from the massive PE group and two from the sub massive and eighty nine point one percent had reduction in RV strain so that's one of

the risk factors or that's one of the goals endpoints that we look in in every study is RV strain did we improve their RV strain pre and post intervention and that can be measured either under an echo or on a CT scan one thing that we

don't know is by reducing that RV strain did we actually improve their life their quality of life or their overall survival and that's one some of the other studies mentioned 84% of these patients are almost 85 had a reduction

in their pulmonary artery pressure so as interventional radiologists and I believe interventional cardiologists also when we start our case we measure the pulmonary artery pressure we're really measuring the strain on the heart

as a result of the high pulmonary artery pressure so at the end of the case we want to know if we didn't even better and I always talk with our trainees and our team about the fact that once you do one of these cases you're really only

looking at the pressure you're not necessarily looking at what the picture looks like because sometimes the picture doesn't look very very good at the end of a PE lysis but the patients are doing much better one thing that's important

to notice is that there was a thirteen point one percent who had complications had complications that's a large number of patients so when you give patients thrombolysis they can have complications and many of them require blood

transfusions or have large hematomas or pseudo aneurysms and things that require further intervention the ultima study is another study this is a study looking at patients receiving unfractionated heparin so patients got just heparin and

other patients got Kathryn directive thrombolysis so this is the standard of care which is heparin versus TP a from a catheter this was a small group of patients only 59 patients and they were all patients who had acute PE with

an r v lv ratio greater than one so that's sort of night now the new standard the RVL v ratio should be less than one and that's basically just looking on a CT scanner and echo how big the RV is the left ventricle pumps all

the blood to the main to your body so that is much stronger than the than the right and it has a much larger size in on average and this is one of the methods that we use in all studies so what they looked at over time here is

these patients and how there are VL v ratio changed after they either received TPA or whether they got just the standard of care which is heparin and you'll see that there is an improvement in the patients who had a catheter

directed thrombolysis and overall they had better a change in their RV LV ratio so that's sort of the marker that we we have been using but again it still doesn't tell us do these patients live longer do they have better quality life

afterwards this Seattle to study is another study that was performed and this is actually a sort of a changing game-changing study at least for a catheter directed thrombolysis in the beginning this was a

industry-sponsored study it's May it was sponsored by the the makers of eCos catheters but it was what was nice about this study is that it was very well defined everyone had to do the same thing so if you're trying to study if

something works or not it's got to be consistent in this group they had massive patients and sub massive but they all had an RV LV ratio greater than 0.9 on CT every patient got unfractionated heparin or or lovenox low

molecular weight heparin and then they all received 24 milligrams of TPA that's the study everybody got the same thing and what you see here on this on the right is that the patients who had T who had catheter directed thrombolysis all

had a reduction in their RV LV ratio they all had a reduction in their mean systolic mean or systolic pulmonary artery pressure and they all had a reduction improvement in their Mead modified Miller index which is actually

a score of how much clot there is in the pulmonary arteries so that suggests that there's an improvement at least in the short term and these patients had reduced bleeding 13% vs. 10% is reduced it's not still

not great but these patients all got TPA so this is a summary slide from chest to in the chest guidelines in 2015 looking at the three studies I just mentioned to you so perfect Seattle - and Altima and it's basically again

showing you that there has been improvement in patients right ventricular strain as well as the patients mean systolic PA pressures but I will tell you even with this data we still don't know what the right answer

is because we don't know how this affects patients in the long term and how they're gonna do in their overall life so back to our patient to move on

with shoulder I'll go through this hopefully in five five minutes and I'll be under like 20 so frozen shoulder we're going to shift gears so unlike

arthritis frozen shoulder is an inflammatory condition that starts out of nowhere the classic history is a 35 to 45 year old woman who wakes up in the morning and says my shoulder hurts they think they slept on it incorrectly and

the pain does not go away they take medication doesn't go away the pain is worse at night and they can't figure out why it takes him about a month or two to go to orthopedic surgeon the surgeon goes you have frozen

shoulder they can't lift their arm forward they can't lift it laterally and basically it hurts over the shoulder they don't have a rotator cuff tear they don't have an injury they're not a baseball pitcher these are just average

people who are otherwise normally healthy except sometimes it occurs in certain patient populations it's a very prevalent disease and these are some of the risk factors so being female sorry that's an increased risk factor type 1

type 2 diabetics patients with hyperthyroidism even people who have autoimmune disease because there's some inflammatory process going on there are multiple stages one to four like in every disease of course early on it's

just inflammation but you'll see as you get to stage four you get these adhesions and stiffness in the shoulder so if you see someone who's a year out from this diagnosis who's really slobbing symptoms they cannot lift

they're on many of these patients walk around just like this and you they'll go to shake their hand they can't even get their hand out any further than that and so it can be a really progressive disease and really disabling to be

honest on MRI you can see findings that suggest this so on the top two images there are arrows that show exactly what I showed you in the knee this is thickening of basically the lining of the shoulder and they see this actually

even when they do arthroscopy and they actually put a camera inside the joint in these people with frozen shoulder as well remember I showed you this slide earlier exactly what we know more blood vessels in the lining in patients with

frozen shoulder than not more nerves more blood vessels what's been done on frozen shoulder has this been done well that same doctor in Japan dr. Okun Oh had published a study a number of years ago where in 24 patients he injected the

same antibiotic and 2/3 of these patients got rapid pain relief just one week after the after the procedure he analyzed the show and 87% at a month and there was basically no worsening or recurrences in

these patients out to 36 months so very good very good results but again we wanted to replicate that here in the United States so we applied to the FDA for an investigational device exemption study we're performing this study

actually it's sponsored by Tomo and we're enrolling patients who have a diagnosis of frozen children were working very closely with an orthopedic surgeon who just specializes in shoulder joints he's actually a very well

recognized shoulder surgeon so these patients like our knee patients have to be refractory to something and what we're looking for and this is a patient in in our clinical study is that red arrow on the Left points to an image

where that synovium enhances and on the right where the synovium is thickened and same thing here this is a case where it's even worse you can even see that white capsule all the way around the joint very prominent enhancement the

problem with shoulder embolization and we thought this would be great we do all our cases radial for life you know we'll do prostates uterine fibroids y9t we're like this is gonna be great we only have to go from here to here and

everything's gonna be fantastic the problem is you'll see here from this angiogram just at the subclavian artery is that all the vessels come off pointed towards the hand nothing really comes off when you're going this way so

unfortunately when you're going in with your catheter everything looks like you're gonna be going you know reverse and that can make things really painful and you need a 2o French catheter to get into these because they're so small and

they don't make very many - Oh French pre-curved or pre shaped catheters so you have all these challenges that we thought were gonna be we didn't realize in the beginning and the other thing is write everything now has made radial -

coronary or radial two legs or radial - pelvis or celiac but the distance is you can imagine from here to here I need a 90 centimeter based catheter in a 110 or 120 micro catheter I don't really you know people make 80s and 80s aren't long

enough and people make one 10s and they're too long and so we really found this to be actually fairly more difficult than we realized there are also six arteries that you have to get into in the shoulder so it's very

tedious and you have to get into all these and when you're injecting embolic in and around the vertebral artery and you guys recognize that on the image that's on the screen that's the largest artery there so if you're going to get

reflux you want to avoid of course having a stroke so especially in these younger female patients over 35 to 45 and you're taking something and put at risk so it can be a little bit more of a challenging procedure and obviously

if you have you know physicians and a team who are used to doing things like prostate and advanced celiac embolization for example you know that kind of team will be used to this but they're definitely more challenges than

we realized and so there are six arteries that we have to get into and you can see that third one of how tiny that is and I'll go through all these really quickly this is the suprascapular artery okay this is the first branch we

actually just number them one to six and you could see over that shoulder on the left look how hyper vascular that's actually worse than the knee that's pre-imposed embolization okay this is the throttle acromial artery the

throttle chromia artery as you can imagine goes to the acromion process and the shoulder and you can see on the left it sort of drapes over the shoulder as that hyper vascularity this is the coracoid artery you will not

find this artery in any anatomic textbook anywhere when I flew to Japan to work with dr. Okun oh when I went there and he's like we're going into the coracoid I'm like where is this I'm sitting there on my cellphone like while

he's doing the case looking up the cord under I couldn't find it anywhere looked in Grey's Anatomy looked at oof lockers masculine angio textbook it's nowhere it exists and just like you think it goes right to the coracoid

process which you can see on the image on the right and you can see the degree of vascularity and it's responsible for this anterior pain that patients feel and here's the circumflex scapular artery most of you have probably seen

this in some form or another and as you can see it goes to the inferior aspect of the shoulder so that goes to the bottom of the capsule on the right you can see how it's coming right under the humeral head and then there's the

anterior and posterior humeral circumflex arteries one in front of the humeral head one behind the Hume right so these six arteries we have to get into and we have to figure out which are hyper vascular and that embolized them

and of course like in prostate like in every other place is going to be aberrant anatomy our very first case we go into I came back from Japan we're all excited to start the clinical trial I'm looking for the I'm looking for the

suprascapular artery and lo and behold it comes off the lean of the Lima and I'm like oh that's interesting you know how the heck we're getting in this and so you run into these challenges just like in any other situation and so we're

learning we're getting through this and learning about this patient population as well I will tell you so we don't I don't have any preliminary data to share because we just have done eight patients out of 20 but all but one had a dramatic

improvement I mean even far better than our knee patients they're coming in there like 10 out of 10 they're like do this I had a patient we made a video because she wants to show her orthopedic surgeon if her arms just throwing around

like this and she was like dancing in my office and I'm texting and pictures it's really remarkable and what's great about this is there's no treatment option so orthopedic surgeons said them to go get physical therapy take pain meds there's

nothing to do for these patients so this is a real opportunity hopefully by the end of you know this year we'll be finished and rolling and following up on these patients and we're hoping by maybe early 2020 which is not too far away

you'll probably see an fda-approved product even for the embolization so things are moving pretty quickly and just as just one case again if someone who has severe superior labral pain you can see the image on the right how

densely standing or vasco's it's very easy to see and I'll challenge you when you go back and you're doing a leg angiogram and you look and they do a run off and you see staining around the knee or some of that blush just reach over

and ask the patient and palpate right where it is and go do you have pain right here and I'll bet you they'll say yes you never really would have paid attention at any time before and now we do it kind of for fun when we're doing

our run offs for other reasons of course for CLI etc but it's really interesting and you'll go back and see that so in conclusion embolization really is an exciting has an exciting future really in the setting of msk related pain there

will be need to be many more larger studies of course this is still investigational we do not tell people to go out and start doing this we need to really better understand how angiogenesis really affects these

disease processes and with that I will finish thanks very much [Music]

I'm gonna talk about me and shoulder embolization I'll take out my phone here so I know the timer perfect and I will try and cover everything about knee and shoulder embolization as quickly as I can so why are we doing this is really what I'm going to talk about there are

two different disease processes and the knee we're talking about arthritis and in the shoulder I'm talking about frozen shoulder so these are my disclosures obviously you know knee knee osteoarthritis is a major problem that

affects more than 30 million people in the United States and there are more than a hundred thousand hospitalizations a year just from NSAID toxicity in this patient population who takes NSAIDs for pain of course and they end up with

things like GI bleeds there are more deaths just related to n says the United States and there are more than four million knee injections performed annually in the

United States keep this in mind there are double-blind randomized placebo-controlled studies that show that knee injections don't work and yet there are four million every year okay so what's the rationale for genicular

artery embolisation so in the knee we always learn that knee arthritis is degenerative right there's no inflammation like rheumatoid arthritis but many years ago they discovered that there's actually an underlying synovial

inflammation that leads to an increase in these cytokines being released that leads to new blood vessel growth or angiogenesis and then this is the cycle of pain that occurs after that how does this actually occur and like I mentioned

it's not a new concept here as you can see this is a depiction from a 2005 article from Journal Rheumatology it just blown-up knee joint and what happens here is in the lining with that sort of peach color or light color on

the lateral aspect of the image where it says synovium gets inflamed releases these cytokines those cytokines break down the cartilage lead to new blood vessel growth and it's an inflammatory process so not just a degenerative

process and that it's that inflammation that we aim to target with genicular artery embolisation if you even take biopsies of patients who have inflammatory diseases and the joints here if you look at those two

slides on top we're all those little dark staining blood vessels there there that's a biopsy specimen from somebody with frozen shoulder to two slides below or actually biopsy specimens of someone's synovium who has just a

rotator cuff tear and you'll see there's no increased blood vessels in the two slides below but on the top there are increased blood vessels every time you have more blood vessels you have more nerves that's why they

call it a neurovascular bundle because they travel together so that's what leads to the increased pain and sensitivity so in the knee there have been studies like 2015 we published that study on 13 patients with 24 month

follow-up for knee embolization for bleeding which you may have seen very commonly in your institution but dr. Okun Oh in 2015 published that article on the bottom left 14 patients where he did embolization in the knee for people

with arthritis he actually used an antibiotic not imposing EMBO sphere and any other particle he did use embolus for in a couple patients sorry EMBO zine in a couple of patients but mainly used an antibiotic so many of you know if

antibiotics are like crystalline substances they're like salt so you can't inject them in arteries that's why I have to go into IVs so they use this in Japan to inject and then dissolve so they go into the artery they dissolve

and they're resorbable so they cause a like a light and Baalak effect and then they go away he found that these patients had a decrease in pain after doing knee embolization subsequently he published a paper on 72 patients 95

knees in which he had an excellent clinical success clinical success was defined as a greater than 50% reduction in knee pain so they had more than 50% reduction in knee pain in 86 percent of the patients at two years 79 percent of

these patients still had knee pain relief that's very impressive results for a procedure which basically takes in about 45 minutes to an hour so we

these are our prospective CDT trials it's a lot to go through them so I'm not going to suffice it to say that the only one of these that is randomized is the

one in the top left the ultimate trial with 59 patients the rest of these are single set are single arm studies the optimized trial was randomized but the key arm it did not have was a control arm so all it did was vary the amount of

drug but there was no control arm to tell us how are people doing if they just get heparin well and I'll show you one result from these trials that is the most important result and that is up from the ultimate trial at 24 hours CDT

catheter to thrombolysis reduces the RV to lv ratio to a greater extent than heparin alone what does that mean so you saw all those pictures with the big dilated right ventricles our surrogate measure for right ventricular

dysfunction is the ratio of the diameter the inner diameter of the right ventricle to the left ventricle what we found in this study was that that ratio got reduced to a greater extent at 24 hours in the CDT arm compared to heparin

alone that means that CDT seems to reduce our V dysfunction faster than heparin now importantly 30 days later the echos looked identical so really it's a question of time which is not surprising what we've noticed in

our practice is that patients feel better faster okay I'm gonna go through the rest of this because I'm out of time but I want to give you a little bit of a sense of where we're going because there's bleeding associated with CDT and

maybe I'll show you this that in the Seattle to trial there was an 11% major bleeding rate now this was a pretty conservative definition but there were some serious bleeds and there were no intracranial

hemorrhages in this study but we have realized that CDT is not risk-free it's not like we've all of a sudden gained all of the advantages of systemic thrombolytics and none of the disadvantages now the rate of

intracranial hemorrhage seems to be about tenfold less but it does happen about 0.2 to 0.4% of the time the rate of major bleeding seems to be about 5% which is about half the rate of major bleeding that we see with system or

thrombosis so bleeding is still there it just doesn't seem to be as frequent so that's where some of these other devices are coming in then our a float Reaver the the the extra penumbra indigo cat 8 device and so the the float Reaver is

has actually gone through the full trial and the results are about to be published what is this thing well it's this pretty big hose which is about 20 French and it goes through the right heart and goes up there and it takes

this clot and literally aspirates it out and these are some of the things that will come out and that's sort of your post picture right there the data showed something similar to what we saw with the catheter directed thrombolysis

trials they had looked at 106 patients are vlv ratio was reduced again there's no comparator arm here so this is just the device on its own with a 3.8 percent adverse event rate and so now we're talking about mechanical devices that

don't use a clot-busting medication therefore you're gonna you can expect less bleeding but you're trading some of that off for a mechanical device that can cause injury to either myocardial structures or to the pulmonary artery so

that's something we have to be highly cognizant of as they're introduced into the market this is the penumbra cat 8 this is from Jim Benenati publication basically showing a couple things that's the separator that is the actual

catheter and that's the sheath back there so you've got poor profusion because of a clot in the inter lobar pulmonary artery and then at the end of it you have better perfusion for lung down there so we actually just completed

enrollment into the extract PE trial 120 sub massive PE patients the same efficacy endpoint you have to remember that has been established by the FDA as a way to get approval this is not the final

study nor should it be the final study when we evaluate these devices so to summarize sub massive PE what does the data not tell us CDT probably reduces the RV to LV ratio at 24 hours that is the main outcome that I want you

guys to remember from the ultimate trial it's associated you didn't see this data so don't worry about that we do see major bleeding and sometimes rarely but sometimes we see intracranial bleeding with CDT as well so what we're missing

from catheter directed thrombosis for sub massive PE is what are the clinical outcomes the RV to LV ratio is a surrogate outcome what about death what about clinical deterioration what about recurrent hospitalization what

about recurrent VTE how are people doing in the long term are they walking as well as they were before we don't know any of this none of the data right so far can tell us any of this information so where do we go from here for sub

case I can make up the ages anyway so it doesn't matter so 43 year old patient on a motorcycle that collided with a deer all right presents with left upper quadrant abdominal pain and now we're looking at a cat scan all right who

wants to look at a cat scan you look like you're up for it what do you think what do you see no no you're not sure so we're looking so the key is the left upper quadrant pain right the patient presented with left-sided pain you

should know that whenever we're looking at a study like this we're looking as if we're talking to the person so the right side is on the left the image the left is on the right side and so if you look on the these are two

images if you look at the right side of the image you can actually see the spleen that's like that beam shape thing towards the back of the patient and what we should see is a homogeneous appearance of the organ but what we're

seeing are some kind of dark grayish lines going through it that's essentially a laceration of the screen that's what we're looking at that's the pathology that will prompt us doing a procedure like this and when we ever we

see a patient with splenic trauma we try and grade the trauma so one thing you're going to hear about is it's a patient with a grey 2 laceration or a great 4 laceration or something like that and that basically just describes the extent

of the laceration through the spleen the further through the spleen it goes the higher the number is the worse it is for the patient okay we tend to get involved with patients who who essentially have grade 3 or higher lacerations and are

hemodynamically stable so in this particular patient this was thought to be a grade 3 splenic laceration but there was not a whole lot of blood around the spleen so we thought this patient had some time to come to

angiography and embolization so here's the angiogram lo and behold what we see is again a blobby thing which is the theme of this lecture remember this is bleeding so we're looking for blobby things and all the way on the right side

of that image you can see that cloud of contrasts that black contrast that's extravasated of contrast that's not normal all the way to the right you guys see it are you good so going all the way to the right that's

what we're trying to do now when we do splenic embolization there's two ways we think about this do we want to go all the way to where the bleeding is all the way out into the screen and embolize one little branch that's injured or do we

want to do something called the proximal splenic embolization we would just put like some coils or plugs right at the origin of the splenic artery with the goal of being to slow down the flow and allow the spleen to heal a lot of it is

just what's possible maybe what time it is how tired we are things like that all factors that weigh into it but here's a little bit of a better view you can see the area of extravasation now here's another picture now we put

our microcatheter out there now you're getting a bit more of a sense of what's going on there you can see the extravagance II the vessel that it's coming from and then we put our catheter all the way out there and now we're

right at the source of the bleeding so our philosophy is if we see bleeding we want to go as far as we can towards the source of the bleeding keeping in mind that whenever we don't get as close to the bleeding as possible we're

sacrificing normal parts of the organ that we're treating and that's the philosophical leap that we make during these procedures so we were able to get out there and then we embolize leaving a lot of flow through the rest of the

spleen and the patient was able to survive like we never did anything alright that's our goal now here's a

kind of the embolic protection because I think with carotid artery stenting the stents there's a lot of different types they're all self expanding for the most

part and there's not a lot to talk about there but there is with regards to embolic protection and there so there's distal and violent protection where you have this where that blue little sheath in the common carotid artery you got a

wire through the ica stenosis and a little basket or filter distally before you put the stent in early on they used to think oh maybe we'll do distal balloon occlusion put a balloon up distally do your intervention aspirate

whatever collects behind the balloon and then take the balloon down not so ideal because you never really asked for it a hundred percent of the debris and then whatever whenever you deflate the balloon it goes back it goes up to the

brain you still have some embolic phenomenon in the cerebral vascular churn and then there's this newer concept of proximal protection where you use either flow reversal reverse the blood flow in the cerebral circulation

or you actually cause a stagnant column of blood in the ica so you can't get you don't get anything that embolize is up distally but you have this stagnant column the debris collects there you aspirate that actively before you take

down the balloons that are in position in the X carotids and common carotid artery and then you take everything out so let's walk through each of these if you really wanted to pick out the perfect embolic

protection device it's got to be relatively easy to use it's got to be stable in position so it's not moving up and down and causing injury to the vessel but even while it's in place cerebral perfusion is maintained so that

balloon the distal balloon not a great idea because you're cutting off all the blood flow to the brain you might stop something from embolizing up distally but in the process of doing that you may patient may not tolerate that you want

complete protection during all aspects of the procedure so when we place a filter as you'll see just crossing the lesion with the initial filter can cause a distal embolus so that's a problem you want to be able to use your guide wire

choice as many of you know when we go through peripheral vasculature there's your go-to wires but it doesn't always work every time with that one go-to wire so you want to be able to pick the wire that you want to use or

change it up if needed for different lesions so if you get to use your wire of choice then then that's gonna be a better system than something that's man deter and then if you have a hard time using that wire to get across the lesion

you have a problem overall and then ultimately where do you land that protection device and a few diagrams here to help illustrate this generally speaking these distal embolic protection these filters that go beyond

the lesion have been used for quite a while and are relatively safe you can see them pretty easily and geographically they have little markers on them that signify if they're open or closed and we look for that overall and

blood flows through them it's just a little sieve a little basket that collects really tiny particles micrometers in size but allows blood flow to pass through it so you're not actually causing any cessation of blood

flow to the brain but you are protecting yourself from that embolic debris and it's generally well tolerated overall we had really good results in fact when not using this device there's a lot of strokes that were occurring in use of

this device dramatic reduction so a significant improvement in this procedural area by utilization of embolic protection however distal embolic protection or filter devices are not a perfect APD as you as you may know

those of you have been involved in carotid stenting there is no cerebral protection when you cross the lesion if you have a curlicue internal carotid artery this filter doesn't sit right and and ultimately may not cause

good protection or actually capture everything that breaks off the plaque and it can be difficult to deliver in those really tortuous internal carotid arteries so ultimately you can cross the lesion but you may not get this filter

up if you don't get the filter up you can't put the stent then ultimately you're out of luck so you gotta have a different option filters may not provide complete cerebral protection if they're not fully opposed and again it does

allow passage of really tiny particles right so your blood cells have to be able to pass but even though it's less than about a hundred microns may be significant enough to cause a significant stroke if it goes to the

right basket of territory so it's not perfect protection and then if you have so much debris you can actually overload the filter fill it up in tile and entirely and then you have a point where when you capture the filter there's some

residual debris that's never fully captured either so these are concerns and then ultimately with that filter in place you can cause a vessel dissection when you try to remove it or if it's bouncing up and down without good

stability you can cause spasm to the vessel as well and so these are the things that we look for frequently because we want to make sure that ultimately if we just sent the lesion but we don't believe the vessel distal

to it intact and we're going to have a problem so here's some kind of illustrated diagrams for this here's a sheath in the common carotid artery you see your plaque lesion in the internal carotid artery and you're trying to

cross this with that filter device that's what's the picture on the right but as you're crossing that lesion you're you're liberating a little plaque or debris which you see here and during that period of time until the filters in

place you're not protected so all that debris is going up to the brain so there's that first part of the procedure where you're not protected that's one of the pitfalls or concerns particularly with very stenotic lesions or friable

lesions like this where you're not protected until that filters in place that first step you never are protected in placement of a filter here's an example where you have a torturous internal carotid artery so you see this

real kink these are kinds of carotid internal carotid arteries that we can see and if you place that filter in that bend that you can see right at the bend there the bottom part the undersurface of the carotid doesn't have good wall

my position of the filter so debris can can slip past the filter on the under under surface of this which is a real phenomenon and you can see that you can say well what if we oversize the filter if you oversize the filter then it then

it just oval eyes Azure or it crimps and in folds on itself so you really have to size this to the specific vessel that you plan to target it in but just the the physics of this it's it's a tube think about a balloon a balloon doesn't

conform to this it tries to straighten everything out this isn't going to straighten the vessel out so it doesn't fully conform on the full end of the filter and you have incomplete a position and therefore

incomplete filtration so this is another failure mode I mentioned before what if it gets overloaded so here's a diagram where you have all this debris coming up it's filling up the really tiny tiny particles go past it because this little

micro sieve allows really small particles to go distal but approximately it's overloaded so now you get all this debris in there you place your stent you take your retrieval filter or catheter to take this filter out and all that

stuff that's sitting between the overloaded filter and your stent then gets liberated and goes up to the brain so you got to worry about that as well I mentioned this scenario that it builds up so much so that you can't get all the

debris out and ultimately you lose some and then when the filter is full and debris particles that are suspended near the stent or if you put that filter too close to the edge of the stent you run into problems where it may catch the

stent overall and you have all of this debris and it looks small and you don't really see it and geographically obviously but ultimately is when you do a stroke assessment and it's not always devastating strokes but mild symptoms

where he had a stroke neurologist and the crest trial or most of the more recent clinical trials we actually evaluate a patient and notice that they had small maybe sub sub clinical or mild strokes that were noted they weren't

perhaps devastating strokes but they had things that caused some degree of disability so not insignificant here's a case example of a carotid stent that was done this is a case out of Arizona proximal carotid

stenosis stent placed but then distal thrombus that developed in this case and had post rhombus removal after the epd was removed so there's thrombus overloaded the the filter you can see the filter at the very top of the center

image you can see the sort of the shadow of the embolic protection device there distally aspirated that took the filter out and then ultimately removed but you can imagine that amount of thrombus up in the brain would have been a

devastating stroke and this is what the filter looks like in real life so this is what the debris may look like so it's not this is not overloaded but that's significant debris and you can see the little film or sieve that's on the

distal part of this basket and that's what captures the debris any of that in the brain is gonna leave this patient with a residual stroke despite a successful stenting procedure so this is what we're trying to avoid so in spite

there are advantages of this modality one there's less radiation exposure for

the patient we receive about three millisieverts of background radiation every year with one PET scan a patient can get up to eight years worth of background radiation in just one skin the only exposure of radiation a patient

gets in a pet MRI is through the isotope pet MRI has a better disease characterization especially for areas in a Patou biliary region the pelvic areas and the kidneys information and the relationship between lesions and

adjacent tissue is better delineated with the pet MRI so it's easier to see which part is cancerous and which partners normal cells there are varying opinions and research studies are being done to make a determination if pet MRI

is a better modality than pet CTS well PET CT is a lower-cost skin has increased accessibility there are more PET scanners available and more more technologists are trained for this modality PET CT is a shorter skin there

are no contraindications for affairs implants pet CTS are preferred method for imaging the lungs of thoracic nodules and bone structures however with a pet MRI it's good for soft tissue organs such as the brain the muscle

delivered the kidneys the pancreas our GYN pelvic structures such as ovaries the uterus and cervix and also the prostate there are limitations of this skin one it is a much longer skin one whole body pet MRI can last at least

about an hour there are contraindications with certain implants due to the magnetic factor of the of this test and is not preferred for imaging air-filled structures because it can give off artifacts there

are weight limitations for our machine our machine holes can hold up to about 500 pounds of weight it is this our machine as smaller bore compared to the white board MRI the MRI whiteboy is about 70 centimeters in diameter

our pet MRI machine is only 60 centimeters in diameter in this picture the difference of the 10 centimeter difference doesn't seem much however if you put a patient in there and this is one of our coworkers

he is 270 pounds and 6 feet tall and the white board MRI his shoulders fit comfortably well inside it in the sky inside the scanner however in this pet MRI machine he said he did feel a little snug and a little tight inside

but you also have to take an account that we have to put coils on top of our patients that 10 centimeters does make a big difference the coils will help us give the good quality images that we like and I also have to note that we

have to put the head coil or the helmet on top of the patient's head to give good images of the brain the reason why the pet MRI scanner is smaller is because we have to make room for the pet detectors we try to make it bigger the

gradient coil on the radiofrequency coil have to be further away from the center of the magnet and that compromises the quality of our images so which patient

after having these two cases one in our institution and one at University of North Carolina Chapel Hill that we would then basically upsize our particles to

100 micron and we have not seen that and we're doing a second clinical study and I'm not seeing that as either we had about a 70% reduction in pain so if you look at our visual analog score out to six months and if you look at our

disability it actually paralleled this exactly which is pretty impressive considering mostly patients had bilateral knee pain so out to six months very good results 90% of patients were responders so two

out of our twenty patients did not really respond one patient didn't respond at his one-month follow-up but did respond at his three and six so I still consider him a clinical failure because we expect

these patients to respond by one month here's just an example of a baseline MRI before and after and you can see all that joint effusion there the white that decreases just even after a month how much it decreases and we looked at this

in terms of synovial thickness and distension and even on MRI you can object objectively count calculate synovitis scores and we calculated that they actually statistically decreased this is another patient on the left the

image shows diffuse white enhancement if you will of the synovium of the lining on the right it shows the fluid this is an image just of embolization and I show this image because it's really shocking and this is actually one of our nurses

who's enrolled in a clinical study is this is before this is all we did we embolized the medial aspect of the knee this is one month later 30 days in fact somebody just asked me this when I was in the booth over at the meeting across

the street and basically I said listen I don't know why this happened so quickly I have no idea we didn't tap renu-it into anything else if you look at this premium post it's pretty dramatic so clearly there's an inflammatory process

that we are arresting or stopping in such a short period of time so is there a future for this I don't know it may just we may just fall down and find out that there really is in a great future but so far we know it's at least

technically successful it's the results are positive in the short term long term we're not so sure yet we do need to better understand these risks and I think in my opinion in the long term it'll probably be really really good for

this 40 to 65 year old patient population who's not yet ready for knee replacement surgery this is the algorithm for our clinical study which were almost done enrolling right now it's a randomized control study against

placebo so it's two to one randomization which means one third of the patients actually get a sham procedure so we do an angiogram on their leg they're asleep they have no idea for embolizing they're genetical it arteries or not we wake

them up I think about the table and we follow them up if they're no better they're allowed to cross over and get the treatment the other 2/3 of the

and you can see on this t1-weighted image that increased area of enhancement which is the area of synovial thickening you actually see this on MRI beforehand and there it is located over the lateral aspect of the knee on the axial image

and so what we're doing sorry in the medial aspect of the knee so what we're doing here on the angiogram is and you solve these leg angiograms where everyone doesn't really care about these Janicki lit arteries they're really

important when you have sfa or popliteal occlusive disease because they serve as a collateral source but otherwise and people have arthritis they can be a real pain and pain in the knee if you will so this is a this is the superior medial

genicular artery it always drapes over the femoral condyle and you'll see here on this image you don't really see very much once we get into the vessel look at this it almost looks like a small about a cellular carcinoma like when you're in

the liver you get this tumor type blush vascularity that's what we're looking for that corresponds to the patient's area of pain and then after embolization this is what it looks like takes a very small amount

of embolic we're using maybe 0.4 2.6 sometimes 1 CC at most of dilute embolic that we're injecting this is another case again before and after if you look here on the right and then on the left you don't really see much until you

select the vessel out once you get into that super medial vessel you can see how much enhancement there is so in our clinical study of 20 patients this is what we did you'll see on the bottom here we used embassy and 75 micron in 9

patients and 1111 patients got a 100 micron and I'll explain why we upsized our particles so initially we wanted to go very small because that's what dr. o Cano had done in Japan but then we wanted to actually up size our particles

and I'll explain this here in our complications so like all clinical studies the purpose of doing really good clinical research is because this is early and we don't know if they're going to be complications and it's always fun

when you're the first one to figure it out and you tell patients I don't really know what's gonna happen and this is what happens so 13 patients had this kind of skin discoloration over their knee now we knew this because we've been

doing knee embolization for about 10 years in bleeding patients not necessarily arthritic patients so we had seen this before but none of these patients in this clinical study went on to have any alteration of the skin and

it resolved in all patients there was some minor side effects from basically medications and one small groin hematoma but there were two patients who developed plantar numbness over their great toe so under their great toe

basically in the medial distribution of their tibial nerve they ended up getting plantar numbness and this is believed at least in our experience to probably be related to non-target embolization to the tibial nerve the tibial nerve

probably gets its blood supply from many of these generic arteries so we decided

they travel together so that's what leads to the increased pain and sensitivity so in the knee there have been studies like 2015 we published that study on 13 patients with 24 month follow-up for knee embolization for

bleeding which you may have seen very commonly in your institution but dr. Okun Oh in 2015 published that article on the bottom left 14 patients where he did embolization in the knee for people with arthritis he actually used an

antibiotic not imposing EMBO sphere and any other particle he did use embolus for in a couple patients sorry EMBO zine in a couple of patients but mainly used in antibiotic so many of you know if antibiotics are like crystalline

substances they're like salt so you can't inject them in arteries that's why I have to go into IVs so they use this in Japan to inject and then dissolve so they go into the artery they dissolve and they're resorbable so they cause a

like a light and Baalak effect and then they go away he found that these patients had a decrease in pain after doing knee embolization subsequently he published a paper on 72 patients 95 needs in which he had an

excellent clinical success clinical success was defined as a greater than 50% reduction in knee pain so they had more than 50% reduction in knee pain in 86 percent of the patients at two years 79 percent of these patients still had

knee pain relief that's very impressive results for a procedure which basically takes in about 45 minutes to an hour so we designed a u.s. clinical study we got an investigational device exemption actually Julie's our clinical research

coordinator for this study and these are the inclusion exclusion criteria we basically excluded patients who have rheumatoid arthritis previous surgery and you had to have moderate or severe pain so greater than 50 means basically

greater than five out of ten on a pain scale we use a pain scale of 0 to 100 because it allows you to delineate pain a little bit better and you had to be refractory to something so you had to fail medications injections

radiofrequency ablation you had to fail some other treatment we followed these patients for six months and we got x-rays and MRIs before and then we got MRIs at one month to assess for if there was any non-target embolization likes a

bone infarct after this procedure these are the clinical scales we use to assess they're not really so important as much as it is we're trying to track pain and we're trying to check disability so one is the VA s or visual analog score and

on right is the Womack scale so patients fill this out and you can assess how disabled they are from their knee pain it assesses their function their stiffness and their pain it's a little

bit limiting because of course most patients have bilateral knee pain so we try and assess someone's function and you've improved one knee sometimes them walking up a flight of stairs may not improve significantly but their pain may

improve significantly in that knee when we did our patients these were the baseline demographics and our patients the average age was 65 and you see here the average BMI in our patients is 35 so this is on board or class 1 class 2

obesity if you look at the Japanese study the BMI in that patient that doctor okano had published the average BMI and their patient population was 25 so it gives you a big difference in the patient population we're treating and

that may impact their results how do we actually do the procedure so we palpate the knee and we feel for where the pain is so that's why we have these blue circles on there so we basically palpate the knee and figure

out is the pain medial lateral superior inferior and then we target those two Nicollet arteries and as depicted on this image there are basically 6 to Nicollet arteries that we look for 3 on the medial side 3 on the lateral side

once we know where they have pain we only go there so we're not going to treat the whole knee so people come in and say my whole knee hurts they're not really going to be a good candidate for this procedure you want focal synovitis

or inflammation which is what we're looking for and most people have medial and Lee pain but there are a small subset of patients of lateral pain so this is an example patient from our study says patient had an MRI beforehand

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