The symptoms are two-fold, or they are obstructive symptoms,
such as hesitancy, straining to void, weaker stream, prolonged micturition, urinary retention. That's the extreme symptoms of obstructive symptoms. And then irritative symptoms that are frequency, urgency, nocturia and urge incontinence.
So all of these are measured by a paper called IPSS score.
It's a score sheet that is not very obvious to understand at the beginning, but you just need to answer the question and see how often those symptoms happen. It ends with the quality of life related to urinary symptoms.
Usually, we consider that any IPSS score of one to seven is mild symptoms, eight to 19 is moderate symptoms, and 20 and above is severe symptoms. So that's something we have to have in every patient, to make sure we understand the degree of disease
and their symptomatology, and of course quality of life is very important.
So what are the options? They are a lot of options, but the first option, usually, is to try to change the lifestyle
and make sure the patients don't drink too much coffee in the evening or too much water or alcohol and try to make sure that they can manage that, but very often that is not enough. So, the pharmacology therapy is now the next step, which would include two types of drugs,
alpha blockers or five-alpha reductase inhibitors. Those materials come with their own limitations and side-effects. They are some major side-effects, and a lot of patients don't like it. Of course, then there is surgical approach,
and you see here a series of these. I didn't even add the last two-three procedures that were added. And when you see a lot of procedures for the same disease, that means none of them really works very well. And that's important.
If you had a very good procedure that was working, you wouldn't create 10 different procedures.
But the gold standard is TURP. It used to be surgical prostatectomy for larger prostate. It's now mostly a transurethal resection of the prostate, but some centers now they are doing more of laser,
and that's also worth for some larger prostate. These are some of the complications of TURP, beside the fact that you have to put a very large tube through penile tissues that are scary for men. There's a lot of other complications, such as incontinence, UTI, hematuria,
and erection disfunction, retrograde ejaculation. So it's scary for many of the patients. Even urologists recognize that they are needs for newer or better procedures.
Prostatic artery embolization is not new because we have been using embolization
for a lot of other indications, such as prostatic bleeding and cancer, and so there has been, in the last three decades, at least 130 cases of prostatic artery embolization. But what is new is actually the indication for BPH. It is a minimally invasive procedure.
It's outpatient procedure. It can be applied to patients with contraindication to surgery or limitation of surgery, like patients with low platelets, patients with bleeding, large prostate, patients that need general anesthesia. And it's well-tolerated in general.
So how does that work? We think that by reducing or stopping the blood flow to the prostate, you will have a shrinkage of the gland, and changing the consistency of the prostate from a solid organ to a more softer organ,
so that it can reduce the pressure and compression to the urethra.
Animal studies have been done. A lot of them. In general, what we've found with animal studies is that PAE induces prostatic volume reduction.
In general, there is no injuries to other organs. We see evidence of cystic changes, and some area of glandular necrosis. Here is one example showing a cystic change in the prostate after embolization in an animal model. And this is an example of one of our patients,
where we see before embolization a prostate of 90-something grams. After embolization, you see this area of necrosed glandular tissues.
So the first case, like a lot of things we do, was an accidental finding.
Dr. DeMeritt published a case of a patient with BPH that had bleeding, and when they treated the BPH they realized that the patient symptoms went away. A few years later, Francisco Carnevale worked on a two-patient
that were published in CVIR, and then Dr. Pisco published their first experience in 15 patients. This is the first 15-patient, and we see with this that the majority of patients decreased their IPSS scores significantly.
They had a better quality of life, and the prostate volume reduction was about average of 26.5 gram or milliliter. Carnevale also published their result in patients with indwelling catheter. It's really a painful thing to have a catheter for long-term
and the first 12 patients they embolized they have seen-- The first 11 patients, 10 successful cases, and the patients actually were able to remove the catheter within a few weeks after embolization. So more studies, and I'm just going over those data quickly, showing that the success rate varies from 80 to 70 percent
over a couple of years post-embolization. First American publication was done by Bagla in 20 patients, and they show a very good successful result, 95%. And these are the improvements in the quality of life and IPSS score and prostate volume.
This study from China compared two groups.
One that had TURP, the other group had PAE. It's a prospective randomized trial. They show overall that, even though they said they were more clinical failures with the PAE group compared to the TURP group, but with time the outcome of clinical success was the same.
We have published here a letter to editor against this paper, because they didn't consider things like bleeding, transfusion after the TURP as a complication. So this data, even though it was biased against PAE, end up to be a very good result
showing that PAE finally after three months had the same symptoms improvement than TURP. Another study from Dr. Kurbatov studying eight patients with larger prostate, and the result at one year show significant improvement. You see all this data showing IPSS score in average dropped.
The quality Qmax, which is the flow rate, maximum flow rate, increased. PVR, post-void residual, dropped. And then PSA, which is a marker of inflammation, at the beginning was higher and then dropped with time.
So I'm going to show other results.
There are discussions about the small size of particle. It seemed that with smaller particle you may get more necrosis to the prostate, but the outcome, in terms of clinical outcome, was similar. And then Carnevale also studied different techniques of embolization.
They describe a technique where you embolize at the origin of the prostatic artery, and then you go more distally and then embolize more distally. They called it PErFecTED technique, which is proximal first and then distal.
With that technique it seemed that they had a better outcome in general.
So how to start PAE? How many of you are working in divisions that have a PAE program? Few.
Yes. If we would have asked that two years ago, there were almost nobody. There are more and more people doing that. I think the first thing you really need to be convinced that this is something that works.
In 2011, I was hesitant, so I went to see Pisco's group in Lisbon. They did four cases on a Saturday after 4p.m. No, sorry. After, yeah, after 4p.m. Four cases.
I just flew from Minnesota, I was jet-lagged, and watched four cases on a Saturday. Nobody was in the hospital. And then at midnight I was almost dead, and he said, "Let's go and have dinner". Curiously, every restaurant was open,
so we had a good dinner. But actually when I saw the case at that time, I said, this is something I can do and we should do. So we did the first case in the U.S. in 2012. And I think you need to know that, you need to make sure that,
you involve your urologist soon enough, even though you will have a lot of resistance from the majority of urologists. The turf problem will never end with IR, and that's who we are.
So best candidates.
Of course patients should be symptomatic. Having a large prostate doesn't by itself justify anything. Make sure we evaluate the patient and do a clinical exam. Make sure the patient doesn't have an infection, there is no bladder disfunction that can explain the symptoms.
Make sure that the patient doesn't have a very high PSA related to eventually cancer. So even though it is not a requirement, we always check the PSA, and make sure that if there is a high PSA that can't be explained, we do a biopsy.
And then we absolutely need to know the uroflowmetry, which is mostly Qmax. And then after all of this, we measure the prostate volume with MRI or CTA. And then we get the patient ready for the procedure, if the patient is a good candidate.
Who is the best candidate? Start with a large prostate, because large prostates have large vessels in general. So it's easier to do. You don't want to fail your first case, and then go back for another two years
to get the next patient. The patients that are contraindication to surgery, like always, we go and say to the surgeon send us whoever you don't want to treat. These are difficult patients but that's the way to start. Patients that have low platelets, high risk of bleeding.
Here you see a prostatic artery in a patient with 40 gram prostate, that we don't catheterize. You see the catheter size is almost the same as the artery. And this is the prostatic artery in a patient with over 120 gram prostate.
So it's much easier to catheterize. That's a good start.
The data showed that if you have larger prostate, the outcome is better. So you have better technical success. Who else is a good candidate?
Patients who refuse surgery, patients who have hematuria, previous pelvic radiation or intervention. They are really contraindicated, or difficult cases for surgery. And the indwelling catheters, as we discussed,
can be a good way.
Now, we need to know PAE is not UFE, and that's what I always show in every meeting. As you know, we are very familiar with UFE, and it goes fast in centers. I am sure Gary Siskin does that in 20 minutes per side.
So we can do UFE much easier. The patients are younger. But with PAE they are mostly older men with tortuous vessels, smaller vessels, and dangerous anastomosis. So it's very important to learn that technique.
I'm going to pass over the explanation of the anatomy just to tell you that the majority of vessels comes from internal pudendal, or the common trunk of the anterior branch, or from the obturator. These are the major vessels that you have to keep in mind,
but we have branches coming from posterior, a branch of the superior gluteal. There are branches that we identify coming from external iliac. Like everything else, there are a lot of variations. Here it's how it looks like.
It's the AP view. You see a couple of vessels going to the midline, but you see the one that is really tortuous, and some people say S-shape. It's probably the one going to the prostate. Anatomically there may be more than one branch per side
going to the prostate. Catheterization of this branch. You start to see the blush of the prostate. That's really a good place to be. We usually do Cone Beam CT, and I know that a lot of techs and docs don't like that,
but if you want to do PAE you need to master Cone Beam CT. It is sometimes time-consuming, but it is very important, because that shows that you are in the prostate, and also that shows that you don't have any non-target embolization.
In this patient we did that, and we embolized the prostate, and, for some reason, it jumped. This patient had the other catheter. So we went to do the embolization of the right side, so you do embolize both sides.
And I always blame it to my fellows who dissected the prostatic artery, so we brought the patient back a few weeks later, and then we catheterize another branch and we see this capsular opacification of the prostate. So sometimes when you embolize a vessel,
you know that you need to follow the other branches that try to feed the organ, and that's not an exception with PAE. So you see the organ that was embolized once, and then we embolize it a second time.
Let's move away from anatomy discussions.
One thing that's important, and this is my artwork, I draw it in a Coca-Cola napkin when I was traveling. One thing is to find what are the branches going to the prostate, but once you catheterize the prostate, you see a lot of distal anastomosis.
It's very unusual, but you don't see something like this in other organs. But you may see a branch going to the prostate, and then suddenly you see from prostate some branches go to rectum or bladder or to pennis.
So it's important to master the anatomy,
but also try to have a good Cone Beam CT to detect that. The technique of Cone Beam CT, there are a lot of different techniques, but my preference is to do hand-injection, slow injection, and the injection should mimic the embolization. So I don't want to have reflex.
I don't want to have too forceful injection just to see where I am, what would be my expectation.
This is a case where you see two branches going down. This one goes down, it looks like the rectal branch. So we did a Cone Beam CT. You see the first branch goes to the prostate.
But if you follow the other one, you see it's going to the rectum. So Cone Beam CT can confirm the position, and then decide to change your embolization. Look at this case. This is a prostatic embolization.
At the end of the embolization, you inject a little bit more forcefully. You see all this collateral, and then the branch going to the bladder. So if you're not careful, you forcefully inject it, you can have bladder necrosis.
Another case here. Catheterization of prostatic artery. At the end you see this collateral goes to the bladder. So again, slow injection. And, as I said, painfully slow injection in this patient. So I explain how we do it.
It's a very slow injection over 10 second, 50% dilution of a three-cc syringe.
Another case here, a patient 60-year-old. BPH, IPSS of 22, quality of life of four. Large prostate, 94 cm. This is an MRI that showed large prostate here
with multiple nodules and adenomatous transformation. Catheterization one side. You see this prostate blush. We catheterized it. Selective catheterization. Very good Cone Beam CT,
showing that we are really where we have to be. We embolized this with a total end-point embolization. And then we saw another branch posteriorly from superior gluteal. We catheterized and we did a Cone Beam CT. Although there are some branches going to the prostate,
the majority of this goes to the rectum. We decided not to embolize that. So again, the value of Cone Beam CT. Just to stay on time, I will pass this one.
So, catheters. My to-go catheter was the RUC.
Roberts Catheter, as you guys know. The problem Cook has, there is no RUC catheter available and the copy of the RUC catheters from other companies are not good. Merit has a great series of material, but catheters is not their skill,
and that was something that replaced the Cook catheters very often. You use whatever you like, but I think a reverse curve catheter is the best thing to use, and then of course, microcatheter.
The smaller microcatheters are better, because as you see, the size of the vessels are very small. Particles. You can use any particles you want. I think it's more about the size of the particle, more than the type of the particle.
It seemed that, for us, it was a combination of 100 to 300 microns or few ccs followed by 300 to 500 microns, works really well. And then, like everything else, particle embolization is about dilution, patience, and injections of, I would say,
one cc every four-five minutes. And that's really painful.
followed by 300 to 500 microns, works really well. And then, like everything else, particle embolization is about dilution, patience, and injections of, I would say,
one cc every four-five minutes. And that's really painful. Another case, another patient. I show this large prostatic artery, as you see here, and believe me, it is a prostatic artery. It was a man, it's not a uterus artery.
It looks like a fibroid, but it's not. So this patient's Cone Beam CT showed really a very well placed catheter. A very large prostate. We embolized that to the end point, which was a total occlusion, as you see here.
And then we moved on to the other side. I'm sure we did, but I'm waiting for this to come. And you see again another large vessel. These are the easiest cases I had, and I'm happy that was the first cases I had. But that's why I think you need to use the larger prostate
at the beginning. And again, Cone Beam CT here shows the median lobe, and good positioning of the catheter, and with total embolization. This patient did really well. The first few weeks were harder, and that can happen.
We explain to some patients that maybe the first two-three weeks the symptoms are worse before getting better. He noticed increased flow immediately. He had some hematuria, that can happen also in few patients. We did a cystoscopy to the patient
to make sure that there is no bladder lesion. There was nothing. His IPSS score went from 11 to, everything came almost to one. And the patient actually said that if he can live like this the rest of his life,
he would be a happy man. So far, he's still happy. It is actually a technique that works. You need to really believe that when you have a good patient selection, you can have a good result.
So I'm going to pass over this case because I have four more minutes to go, and to give some time for questions eventually. Other possible indications.
Other possible indications. Embolization prior to surgery to make the size a little bit smaller,
so that you can have a better, quicker, faster surgery. And then, of course, reduction of prostate volume is for non-invasive procedures. Exclusion criteria is like malignacy, atherosclerosis. Make sure that the patient doesn't have a bladder disfunction that can mimic the same symptoms.
And of course, at the beginning of the experience, we need to inject a lot of contrast because it's a difficult procedure. Make sure the patient doesn't have renal insufficiency. The complications can be bladder ischemia. One case has been reported.
Hematospermia, hematuria, pubic and retropubic pain. Rectal pain can happen, but most of these are temporary.
A lot of questions and challenges exist. Like a lot of new techniques, we need to be serious about evaluating it, do good study.
I think the future of this is brilliant, as long as the community do the right thing, we do the right study, understand what are the right patients and what is the ideal technique. So with that I will stop.
In conclusion, I think even though it's a work in progress, I totally believe that PAE is here to stay. There is a learning curve that is longer than other procedures, but I truly think that we can, by a series of good studies,
with collaborations with urologists as much as possible, we can have another bright horizon in intervention. Thank you for your attention.
(applause) - [Man] Questions? - One question.
(woman talking) Excellent question. A foley catheter has been promoted for years by Carnevale, and I was always publicly saying that it's not the right thing to do, because sometimes foley catheter
is the most painful part of the procedure. I think you should do it case by case. If the patient has an advanced obstruction and you are concerned that this may end up to be. The patient could go to acute obstruction, I think it is a good idea.
Or if the patient has a tortuous anatomy, you think the procedure will be long, and you don't want to have a lot of contrast in the bladder, I think it is a good idea. But in general we don't do it systematically. Other questions?
(woman talking) Another excellent question. I always say it's the question of generation. The older generation, even though I want to think I'm younger, but the older generation don't like radial approach.
But I have to say that, in my opinion, radial approach will be the future of a lot of things we do but I am still more in favor of the ephemeral approach. One question there. - [Man] Is there reimbursement for the procedure? - No.
That's a great question. There is no reimbursement called for the procedure, but FDA has approved the material, the embospheres, for prostate embolization. However, there is no CMS code. So some people say, as long as it's FDA-approved
we are going to use the code for general embolization. Some institutions, like ours, they say, it's a little bit of stretch, you shouldn't use it. So we have an agreement with the hospital, with a set fee of 5,000 dollars per patient. And if those patients that are coming to us are IDE,
those are free.
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