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I think we're gonna find this very interesting topic the next one that we have coming up is going to be on transcatheter and bolic intervention a review of the involving therapies the beautiful thing about this is is the speaker that we have is actually a part

of a clinical trial is going on so I led to believe will probably hear hear some of that in some of the techniques used dr. Ari Isaac Isaac's and comes to us from the University of North Carolina where he's performing this and doing

this but prior to that he was he did his medical school in Southern California I completed his radiology residency at UNC and he was in the unc was fortunate enough to keep him and here he is to speak to us this morning or yeah still

this morning alright so the sole survivors that are left here kudos to all of you for sticking around we'll try to make this kind of light and interesting so that we can finish off the conference on a light note here all

right so do I have a seat just a laser up here or something or a mouse or some of them the big green one okay the big green one that's easy enough all right so I'm going to talk to you about prostate elevation how many of you have

seen a prostate embolisation all rights as a few folks two years ago at the avi are there was a technologist named Julie Orlando who gave a talk on prostate embolization and i sat on in the audience and I told her ahead of time

I'm going to sit out there I'm gonna ask you a question in the middle of the tall and sure enough I did and she won't she still lets me know about that all right so let's just talk a little bit i'll give you a kind of an overview of what

we're going to what we're going to do here i'll tell you a little bit about the history of how this came to be and then we'll talk briefly about the evidence why we think it works I'll tell you the kind of the mechanism of why it

works and then talk about how we do it at unc and a little bit more about our experience so just to kind of get

make sure everyone's familiar with what we're talking about we're talking about putting a microcatheter down into the

pelvic arteries that supply the prostate and injecting microparticles until the blood supply of the prostate is limited and causing the prostate to shrink down therefore allowing men to urinate better this is something important and just to

kind of get this out of the way ahead of time because I'm going to talk about it a lot throughout this is how we measure symptoms after prostate animal ization we use something called the International prostate symptoms scoring

survey and as you can see from this it measures multiple symptoms that are associated with bph so including frequency nighttime urination week stream and then at the very bottom there is a quality of life question and so

that's kind of how we collect the data and then unless you kind of see this it's hard to understand the data and just to note that the higher the score the worst the symptoms so getting a lower score is better alright so back in

the 70s and 80s embolization was being performed for prostate bleeding but it wasn't yet understood that this could potentially help bph and there was a big breakthrough when the microcatheter was introduced because prior to that

embolization was being performed from the internal iliac artery was non-selective it was still effective against prostate hemorrhage but it it wasn't until we had a microcatheter that we could start really targeting the

2000 and that's when the case report came out that where a patient was having bleeding from his prostate he came in to have that bleeding treated and when he came to follow up they noted that his

urination was better and they said wait a minute maybe there's something to this if we embolize the prostate maybe we can help people urinate on well then throughout the 2000s this concept had to be proven and before it could be tested

in humans it had to go through animal trials and so that's what happened during the 2000s this is a particularly interesting trial I thought they did it on pigs they did prostate embolization and they wanted to make sure that it did

not affect sexual desire so they embolized these pigs and and then they basically took the pigs after embolization put them into the same sky or whatever with thousand heat and judged rated their performance

and the male pigs did just find so there was no loss of sexual desire and the male takes so this helps get this on to human trials the next kind of phase of

this is what I call the battle of the portuguese-speaking IRS so there's these

two guys the guy on the left there is dr. carnevale from Brazil and the guy on the right is dr. T scale from Portugal and they both started publishing about 2010 and that's what started the human data for pae and so the first paper came

out from Brazil and it was a two patients and you know what basically what it showed was that this procedure could be technically successful and it could decrease the size of the prostate doctor pisco then came out with 15

patients and what he showed was that these 15 patients 11 out of 14 work done success were clinically successful meaning that they improved urinary symptoms and that there was one major complication in this but and so one out

of 15 what it's not a great but it proved later on to be not as frequent as that and this was these were the images from the bat paper and they showed on MRI that the prostate before was larger and then it was smaller after

embolization so what was the complication the major complication in that study was bladder ischaemia that required surgical resection and as we'll see as we kind of go through the data this one major complication is really

one of the only major complications that's ever really been reported with proximal ization so it kind of happened in the very early experience and then is still the major complication that we talked about this is probably the best

study that's ever been done on prostate immobilization and was done in China and what they did was they randomized 57 patients or 114 patients total 57 into into two arms one arm of cross minimization and one arm of terp so

turpitude anima feel familiar with dirt but it's transurethral resection of the prostate use a scope to go through the penis to the urethra and you scrape out the prostate that way and that's the gold

standard for surgical therapy for bph at this point and so what they found these are some great graphs that they put together but if you look at the top to you see ipss and quality of life shows those two questionnaires I was showing

you before and you can see that initially turp is more effective in reducing symptoms so from at the one month three-month and six-month mark it was more effective and then at about six months to 12 months the pae and turf

started kind of equalizing and that's they followed ever went out to about 24 months and at that point the data was pretty similar and so basically if you had to summarize this you would say turf is more effective in reducing urinary

symptoms in the short term but over the long term they appear to be equivalent now again the question is about safety so the advantage of pae is supposed to be that it's safer and so if we look here we can see that at the bottom and

they reported for tae eight major complications but they included technical failure and clinical failure as major complications and we wouldn't consider those complications in our studies so there really weren't any real

major complications for the pae group whereas there were a couple major complications for the turf group so this was a paper that I worked on we tried to compile compile the data that was available we took seven different papers

and took all the patient data that they had for that and we kind of came up with what we called pool weighted means and so if you look you can see that the there are five hundred and thirty-two patients that were analyzed the initial

baseline ipss is very high 24 such severe urinary symptoms and then at six months the ipss had come down to ten in the 423 patients so it's about a 14 point drop in the ipss which is good and then at 12 months there are a few less

patients at 3 45 and the ipss was 10 and so what this demonstrated is when you take everybody study seven different studies and you put them all together you still have this very good effect of prostate analyzation as far as

complications go this is the SI our grading scale and the major complications are great seeing above and you can see there's one major complication amongst all those patients and that was that non-target

embolization to the bra bladder that we required surgery so pretty safe right 500 some patients one major complications not bad so how does PA you

work if you can see this is an mr image with contrast and we're looking at the

prostate i do have a laser on here don't he ok so right here is the prostates right here right and and what you're seeing are the darker parts this is post contrast imaging so the darker parts are areas that are infarcted and that's what

we're trying to do is we're trying to create infarcts within the prostate and those infarctions result in the prostate shrinking down we also think that there might be an effect on the alpha adrenergic nerves which caused a

contract contraction of the smooth muscle in the prostate and so that may result in relaxation of the prostate and softening of the prostate this is a slide demonstrating post embolization demonstrating an arterial here with

anabolic particle and we have a bunch of confluent fibrosis and then these are all this is glandular tissue so this is what the prostate looks like after it's been in boys all right can you start that video for me so this is how we do

pae we start with a really good CTA so we this is going to demonstrate where the prosthetic arteries are rising from and once we have that we can use it to measure prostate volume so we use a tear recon and use a segmentation technique

to measure the volume of the prostate we can also take that same data set and 3d render it and create a 3d model to kind of figure out what are the best angles that we should use them are actually in the case what obliquity should we put

the AI to so that we can get into the prostate prosthetic artery the best and on this particular image you can see you can see the arrows right here are pointing to the obturator artery and then this arrow right here this is the

prostatic artery right here and so you create that image ahead of time and you figure out how you basically plan your case okay and so this is the coral at the DSA correlate here and you can see that we've put the eye is the same

obliquity that we planned and we get a similar image so here's the obturator artery again and here's the prostatic artery coming off and that makes it quite easy to get to where you want to go because you've already planned it

ahead of time I start the video so once we have that data set we can also we have a seaman system and we can overlay it over our live floral and use it as a roadmap and so that's what this is demonstrating it just showed how we used

it to get our five french catheter into the internal iliac artery so I'm gonna

go through a few example cases and kind of show how we use the technology so this was a kind of you know standard bph patient a 67 year old male had lower

urinary tract symptoms or Lutz as we call them secondary to bph and he was treating that with flomax his ipss was 18 which is the high moderate so it's pretty bad and a prostate volume of 80 which is a pretty large prostate normal

is 30 so that's over twice normal and so here's the angiography and we can see that the catheter is here we're injecting there's supply to the prostate here but there's also this straight artery going down and blush a little too

low okay and so especially in the beginning when we started doing these cases we did a lot of cone beam CT to verify where our contrast was going and then where our particles would go and so here's the cone beam CT that's

associated with that and you can see right here we have wrecked them down here and prostates or more up here and we have contrast within the rectal wall and so obviously that's not we don't want to inject particles because we

don't want to embolize the rectum and this is just we verify that we advance the catheter into this straight artery and what you see here is a connection to the superior rectal artery which arises from the

inferior mesenteric artery and so that verifies that this is rectum and so what we did was we place the coil in that straight artery going down hold and then injected again did another cone beam and now in this cone beam you can see that

the prostate the left hemisphere is enhancing and the rectum is not and so that's how you protect the rectum when you're doing that embolisation so I was good to protect the rectum alright so it's been follow-up the patient had no

rectal bleeding which was good he did have a prostatitis that we treated with antibiotics and nsaids at 1-year follow-up his IPSS had gone from 18 25 which is a great result his quality of life had improved from 4 to 1 which is

basically like terrible too good and his volume had dropped from 80 to 82 56 and we got him off his flomax second case

here is 63 year old male 20 year history of bph he has also lower urinary tract systems but he also has bladder stones

and his his bphs progressed to the point where he needs a catheter to urinate and his prostate huge is 150 so that's that's pretty large CT scan from ahead of time demonstrating the Foley catheter here with the splatter stones so they

look like little marbles around them and the axial image showing a huge prostate right here so again I we did the 3d modeling of the CT so we can see this cluster of grapes or his bladder stones and then this demonstrates this middle

branch of the Trident right here is the prostatic artery start the video please so this is again using the overlay so we have our catheter and we have a microcatheter in and we're just basically using this overlay that we've

created to try to get the microcatheter to go into the right place to embolize the prostate and so we're struggling we're struggling okay then we get down there and trying to get the wire to take and

it's pushing my catheter out and then I push the catheter down and then we move down here we do an injection and we can see a nice angiogram of the prostate continuing on the we're going to try to get the catheter a little bit lower so

you can see it's bouncing around a little bit advance it lower now there's that big artery straight artery again and that's something that we have to deal with because that's going to go elsewhere and so we're going to come

down here and basically you can see it actually attaches to the internal padeen dolor communicates with the internal van andel and that's what supplies the penis it's very good also to protect the penis so we put a coil as you can see in there

and then inject again and now we're in a good place to be able to embolize the prostate because we have that coil protecting the penis will go into the next one alright so he came back six weeks post PSC as ipss had dropped all

the way down to five which was awesome his quality of life with zero which is basically I'm ecstatic his post void residual which is how much is left after urinating is only 20 he past 30 plus stones after the procedure all right and

then he was going to go to your all just to get the stones removed but something happened he reported no problems with his erectile function which was great and then he sent me this picture he got all his stones and he laid him out in

size order and next to a ruler so that we could see them but that's not all then he passed some more stones and he sent me another picture so so anyone who says that pae is not real like it's just a placebo procedure I think this proves

that we're actually doing something alright and then just to just around it off you put them on a gem scale so that we could see how much I I always all

right so one more case when we look at it at 57 year old male 10-year history

of issues treated with two medications IPSS really bad at 28 quality of life I've and then his prostate is large not as large as the other guys but in the 50s so one thing that we worked on trying to develop at UNC is how to do

this okay how to do this procedure from the radial artery as you probably know radial artery is becoming very popular in interventional radiology and we wanted to see if it was reasonable to do

a procedure down deep in the pelvis from the radial artery so what why would you want to do it from radio in general radial access provides a kind of a better recovery it's easier on the patient than want the lie flat right

additional advantages for paer that sometimes PA can be really long case if it's a hard case it could be a three-hour case if a patient has lower back pain you can put a bump under their legs right and kind of help them with

their back pain we can't really do that when we're doing some real axis the other thing that's important is that a lot of times we don't we don't like to place foley catheters for this because if you ask a lot of a lot of men who've

gone through this they'll say that placing of folios was the worst part of it so far worse than the actual embolisation so we try to avoid it as much as possible the problem is is that afterwards when they're lying flat for

two hours we've just given them all this contrast and their bladder is really full and they say they have to urinate but because of their obstruction a lot of times they can't urinate lying down so being able to get up and ambulate

right away facilitates their urination and so that's another perk to radial for for radial access so this is just how we set it up and now there's two different ways of yes they do it at Miami a bunch too and they set it out with the arm out

to the side at 90 degrees I like to work like I'm working in the groin because it's what we're used to so I believe we put the arm down by the side now that can present an issue right if you're doing cone beam CT it can be a little

bit so a lot of times sorry I'll be step away from the microphone second a lot of times what we'll do is we'll put the arm kind of folder with the with the elbow event will prep the arm over the belly a little bit so you can take the armboard

out and that facilitates to your cone beam CT okay you know the other thing you can do is go arm up at to your home beam CT but if you have a catheter sticking out of it that's not making a little nervous so it depends it depends

how skinny the person is if they're skinny you can get away with an arm board but if they're a bigger person so that potentially could be an issue but we've tend to work around it and I think it

also depends on which you know what type of floor unit you have okay start the video please so this is just another video of a prompt analyzation done from the radial artery and so we've gotten access into the radial artery we're

running a catheter up have a glide wire so it can get stuck in some side branches so we keep stranding it out we run it up to the chest we go down the descending thoracic aorta we get down into the abdomen keep the glide wire in

the aorta and now we get to where we have the 3d overlay again you remember the trim dealer case the wire keeps wanting to go in the external so we change it around and get into the internal drop down now I'm trying to get

into the obturator which is this down to this branch here and so this is a little aggressive getting my five French into that but I you know I think it turned out okay so there's our DSA run we put our microcatheter in micro wire advance

into the prostatic artery there's our run demonstrate rosetta call ready with another branch that's also supplying the prosthetic and that's our post embolization demonstrating spaces so that's how easy it is you can do it in

15 seconds prostate embolization from the radial artery the great part about radial access as you guys know if you do this is the top of TR band or whatever compress with van der using on afterwards and no one's holding pressure

no one's worried about placing a closure device or anything so it's really nice alright so follow up for this patient so we saw him three to four weeks post pae at six weeks his symptoms worsened and he went into acute urinary retention so

that's the problem he couldn't couldn't urinate at all he was catheterized and they thought he had some prostatitis so he was treated for that the catheter was removed a week later and he was able to urinate at three months he had another

issue but then he passed debris from his penis and his urinary symptoms were instantly better so this was probably hanging out there six months after pae his IPSS was eight and the quality of him too so he's doing well and I think I

have a picture so that's you know little graphic picture for you so that's and he sent it to me in a little baggie he tried to preserve it by wetting a paper towel and putting it in a paper towel on the baggie and I

actually submitted it to our laboratory to see if they could tell me what it was but it was they couldn't they said it was necrotic debris thank you for that

alright so where are we today with tae Seok eh it's performed all around the

country papers have come out of eight different countries at this point so it's all over the world rather in the u.s. tae is not FDA approved if you're treating lower urinary tract symptoms okay hopefully a couple in bollocks will

soon get indications for for bph were hoping on that it however if the if you're bleeding if the prostate is bleeding that is approved that's an indication you can treat or if there's a hyper vascular cancer which we're not

really doing that often but that's something that you can treat as well with FDA approval so just to conclude so pae at this point is shown to be effective in reducing the prostate improving urinary symptoms and the best

thing about PA is is very safe alright so we had one major complication out of 600 cases it's just a really safe procedure hopefully it stays that way there won't be you know more major complications coming out but that's

really the selling point of it right now and the other thing is that for men who have particularly large prostates which is considered probably 80 grams and above Terp is not the ideal procedure at that point they usually have to go on to

something else like an actual open prostatectomy or a laparoscopic prostatectomy or home IAM laser which is another option but that's where pae really can can fill a void or be a better option on the bigger prostates

alright thank you [Applause] ya know is bilateral each time yeah the pictures i show you are single but we aim for bilateral each time and we do that in about greater than ninety-five

percent of our case yeah yeah that's a really good question we're trying to figure that out right now I think there is but we need to we need to study and figure out what it is exactly so potentially so you know some patients

who go on to have brachytherapy there's a size limit for brachytherapy so it's I think it's about 60 or so so some patients have their prospects are too big so we can potentially reduce the size of their prostate and then they can

have brachytherapy which would be good another thing that's potentially out there is that post radiation a lot of patients get bad urinary symptoms so maybe we can do something with that if we do at post radiation but the problem

with that is you can have radiation arteritis like the arteries can get all ragged and then the thing they published at a miami just on treating a materia in prostate cancer [Applause]

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