Sandeep Bagla: I'll be talking about prostate artery embolization and really where it fits in the algorithm of treatment for BPH, if it fits in it all, what the data is. So those are my disclosures. I kind of poke fun at Steve because myself and him poke fun at each other in Twitter. And these are articles in the Journal of Urology, which you've seen over the years. And one of my favorites I wanted to show was his quote there in the bottom left where he quoted Johnny Cochran and he said that, "If the technology doesn't fit, you can imagine, right, where it's going to be." Now, these were many years ago and a lot of data has changed, and Steve and I have discussed this many times, and these editorials keep coming. And to be honest, they're our motivation for folks like me, and I'm hopefully going to convince your mind, and maybe Steve someday, that I think doing this in a comprehensive manner is important.

And I think Steve's talk highlights the most important thing. All of these minimally invasive treatments are important because more than half of men who are offered treatment by urologists walk out the door and say, "I don't want to get that treatment." And that's the bottom line. Those are the numbers, those are the facts. You can look at anything. And we have all kinds of fancy toys and tools that work in many different subsets of patients. The one on the bottom left is my favorite, when you're an interventional radiologist, seeing a patient in that position. But nonetheless, they all have pluses and minuses, and we all have to agree that whether you're good at what you do or not, and if you're good at everything, that's great too. But there's all pluses and minuses. This is what PA is. So it's an angiogram. We put a five French catheter in the femoral artery.

We drive this five French catheter into the internal iliac artery. Then we use a 2.4 French catheter or 2.0, take it into the prosthetic artery, deliver microscopic spheres that you guys are used to seeing in other areas of the body that we embolize. And then the prostate shrinks, and it really has two mechanisms of action. So one is shrinkage, right? It's about 30% average gland size shrinkage. The second is a reduction in alpha adrenergic receptors at the bladder neck and along the prosthetic urethra. You can see MRIs. Those MRIs are in patients who've had the prostate embolization the day before. And the bottom right is a canine explanted prostate. Beagles are really good prostate models. So what's the recovery like after a PAE? Generally the symptoms improve about one month after the procedure, but they continue for about three to four months while that shrinkage goes on.

And they typically experience what we call a post PAE type syndrome, which is like what you would see post biopsy or cysto, frequency, dysuria, nocturia, et cetera. Maybe some hematuria for about seven to 10 days. Very safe procedure. So what's the evidence? Years ago, I agree, Steve's article said very clearly, "There is no Sham study, there is no randomized controlled data." Well guess what? This many years later, there are actually seven randomized controlled studies, six against TURP and one that's actually against Sham. The average reduction in IPSS is somewhere between 10 and 15 points. So I'll show you that. The mean durability is five to seven years. We now have 10 year outcomes data, and it has no effect on erectile function. Absolutely none whatsoever. And the Sham study, which I'll show you, is actually fairly impressive. These are consensus guidelines, as you guys will recognize. These are not the AUA guidelines. That was a joke, Steve. And what we would like to see, right, is there data in other places?

So this is exactly what... Oops, this is exactly what that Sham study showed. What's most impressive about this Sham study, for those of you who have been part of one like I have, it's actually the Sham arm that did so well that's remarkable. It's the bar on top and how they dropped afterwards. And that's what's most impressive. And these are the typical patients you see, failed alpha blockers, gland size over 60. These are the types of patients who are really fairly ideal for PAE. We've done studies on cost. I got a national grant to look at cost of PAE versus TURP in an ambulatory setting. And the cost was one third. That's been replicated now three subsequent times, and obviously it's been done in the setting of hematuria, which most people would agree is actually a fairly good use of it. This meta-analysis shows you really what to expect in terms of outcomes in over 700 patients.

And when you look at this, these numbers, 12, 14, 15 points improvements at one, three, six months, those I believe. The 20 point reduction at 12 months, I do not believe, but nonetheless, that's in the literature. And I can tell you what I like and don't like. This paper was actually fairly interesting in my opinion. Not because our team wrote it, but because it was a meta-analysis of level one evidence, a minimally invasive surgical therapies plus aqua-ablation and PAE. And if you like data, this is a great study to look at. So the middle line bar is TURP, and we took every study, pulled every patient, and compared it to that middle line bar. The closer you are to that bar, the more comparable you are to TURP. The further away you are, the less comparable. The larger the blue box, the more the data. And as you will see as you go to three, six, and 12 month data, the actual patients that actually resembled TURP the most are PAE and aqua ablation, aqua ablation with a better flow rate.

I'm not the only person saying this. This is an article from Claus Roehrborn, who is a very obviously well-respected urologist. And this is the algorithm that he suggested on minimally invasive treatments that are novel. And as you'll see here, PAE ends up fitting in almost every arm of what may be offered to a patient. And I think that's key, except for these very small gland size patients. Where have we seen it effective? We've actually seen it effective, like Steve mentioned, with aqua ablation. In a group I work with in Northern Virginia, I think they've done about 400 aqua ablations and we've done about 200 combination therapies. Why? So we're looking at taking the pluses of aqua aablation, which is bleeding, and obviously patients have to go to the hospital, prolonged discharge, whatnot, CBI, and Foley traction, cautery like you mentioned, and we're trying to combine the aspect of can you do PAE, make this procedure outpatient less costly, more safer?

And I think that's what we're looking at. And personally, I believe that might be some of the future. Where this fits in, right here, fits in with everything else. And I think that's my bottom line message. I think we'll talk about that during the panel is PAE, as good as it is, is not going to be for everybody, but it will be for a certain subset of your patients. And that was really the goal of what we wanted to communicate today. So if anyone has any questions, I'm sure we can ask during the panel. Thanks so much, Neil.