Episode 17

Prostate Artery Embolization

with Sandeep Bagla and Dr. Ari Isaacson

Dr. Ari Isaacson and Dr. Sandeep Bagla share their experiences with prostate artery embolization, including a candid discussion on practice building and equipment.

Cite this podcast: BackTable, LLC (Producer). (2017, November 27). Ep 17 – Prostate Artery Embolizations [Audio podcast]. Retrieved from https://www.backtable.com/podcasts

Full Transcript Below

In this Episode

Podcast Participants

Dr. Sandeep Bagla is a practicing interventional radiologist with the Vascular Institute of Virginia.

Dr. Ari Isaacson is a practicing interventional radiologist with the UNC Department of Radiology in North Carolina.

Dr. Michael Barraza is a practicing interventional radiologist with Radiology Alliance in Nashville.

Disclaimer: The Materials available on the BackTable Podcast are for informational and educational purposes only and are not a substitute for the professional judgment of a healthcare professional in diagnosing and treating patients. The opinions expressed by participants of the BackTable Podcast belong solely to the participants, and do not necessarily reflect the views of BackTable.

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Full Transcript

Prostate Artery Embolization

[Michael Barraza]
Welcome everyone to this weeks podcast with BackTable, your resource to connect to your IR colleagues, and learn tips, techniques, and the ins and outs of the devices in your cabinets. This is Michael Barraza, returning as your host. Today we're talking Prostatic Artery Embolization, or PAE. I have the pleasure to welcome Ari Isaacson, and Sandeep Bagla, two names that are well known to anyone who has followed the evolution in this procedure.

I wanted to briefly share my own experience, and introduce what I believe to be the best opportunity available for IRs looking to adopt this, aside from repeating fellowship. As a fellow at Penn, I did one of these, and only one, and I did it with Tim Clark, who is perhaps the most talented IR I've ever worked with.

 

For the case, he asked me to consider the breadth of what we offer, and our specialty, using the scale of difficulty from one to ten, with one being the easiest, and ten the hardest. I said UFE is maybe a five, TIPS is a seven, and PAE is a nine. Sure enough, that certain case was a slog, and one of the hardest ones I ever did. So, I kind of put this on the back burner in our practice, until after an opportunity a few months ago to observe Doctor Isaacson.

 

This dramatically changed my approach to this procedure, dropping it from a nine, to something I'm comfortable approaching on my own. I'm really looking forward to building on this at Stream, which is an upcoming one-day course on PAE, directed by Ari and Sonny, and the most comprehensive overview currently offered anywhere. Based on my experience with Ari, I'm recommending this to anyone interested in this procedure. I'm even dragging some of my partners with me. It's gonna be in DC on January 13th, 2018. We're gonna discuss details of the course later on, but I encourage our listeners to register at StreamPAE.com while you still can.

 

 

[Ari Isaacson]
Hey Mike. I think Stream is gonna be really strong this year. I just gotta say that.

 

 

[Michael Barraza]
Oh, it's gonna be fantastic. I can't wait. It's gonna be really strong Stream, you know, one and done, no interruptions.

 

 

[Ari Isaacson]
Mat week.

 

 

[Michael Barraza]
So, finally I can focus on our guest. If you wouldn't mind, starting with you, Sonny, I was hoping you could just share your story of how, and when, you guys crossed paths, and how you got from there, to becoming the foremost authorities on a procedure that at the time wasn't routinely done, really anywhere outside of Brazil.

 

 

[Sandeep Bagla]
Sure. So, it's an interesting pathway that Ari and I ... We probably talk very little about how we crossed paths, but, we tend to talk a lot. Maybe three, four, five times a day. Well before the Stream meeting, from everything, from prostate embolization, to hemorrhoid embolization, adenomyosis, you name it.

 

We've crossed paths over the years a few times. Most notably, as you pointed out, in the PA world. A number of years ago ... Ari might have a better memory of how we crossed paths. I sort of remember an email introduction, that Ari might have sent when he was first finishing his fellowship, or first starting at UNC. Ari, correct me if I'm wrong, and maybe you can go back in time, and figure out how we first crossed paths.

 

 

[Ari Isaacson]
Yes, Sonny. So, this is how it happened. I was a very fresh attendee, just out of fellowship, and I had decided that I was going to try to make PAE my research focus. So, I was in the midst of trying to put a trial together, and applying for an IDE.

 

Sonny had already published the only US study on PAE, so I kind of looked up, I said, "Who is this guy that's published already?", and I saw his picture, and he looked like he was 22 years old, and I said, "But he looks like a nice guy.", and I thought, why don't I send him an email, and just say, "What if we got all of the people who are involved in PAE together at SIR?".

 

We sat down and tried to put our heads together, and see how we could advance this procedure quicker. To be honest, I didn't expect Sonny to reply, or anything. I thought, maybe I'd get a courteous, "Buzz off kid." type thing. But, Sonny wrote back, and said, "Hey, that's a good idea.". I ended up calling his cell phone, we talked about it for a while, and we actually made that meeting happen. I'd say Sonny actually made that meeting happen at SIR. What was it? About three years ago, when we all got together in a fancy hotel room, and talked about PAE.

 

But, that's how it started, and Sonny and I each bring something to the table, as far as our relationship goes. It's resulted in some good research, and some good opportunities for us both.

 

 

[Sandeep Bagla]
That's a great summary, Ari. We always say our relationship is not just a friendship, but it's a hashtag collaboration.

 

 

[Michael Barraza]
I like it. The Starsky and Hutch of Prostatic Artery Embolization.

If you guys wouldn't mind, just tell us where you are now, and what's the status of PAE in your current practice? How has it evolved, and what are your future directions?

 

 

[Ari Isaacson]
We've completed one clinical trial on PAE, at University of North Carolina, and we've created a clinical practice now for PAE. We've been doing that for a couple years. We are excited about the indication that Merit recently got for Embosphere. It has opened some doors, as far as being able to advertise, and being able to bill Medicare. Through some efforts to collaborate with urologists at UNC, I've developed a little bit of a referral pattern, which is exciting to me.

 

Now, we have a pretty good clinical practice going on for PAE. Sonny and I are also about to embark on another clinical trial together for PAE, using LC Bead LUMI to perform PAE, and we're excited about that as well.

 

 

[Michael Barraza]
Yeah, that sounds really exciting. I caught wind of that. I'll be really interested to see how that goes.

What about you, Sonny? What role does PAE play in your current practice?

 

 

[Sandeep Bagla]
PAE's, like Ari mentioned, at our practice, Vascular Institute of Virginia, it's really performed primarily on a clinical basis. We are excited as well, for this future study we're doing with LUMI Beads, to look at a number of issues we don't really know yet about PAE, and hopefully we'll learn a lot more with this clinical study we're performing.

 

But, on a daily basis, PAE is an exciting part of our practice. We have built a strong referral pattern, primarily from primary care physicians-

 

 

[Michael Barraza]
Interesting.

 

 

[Sandeep Bagla]
... from practice doctors, and really gone the nontraditional urology route. Maybe that's related to the fact that, over the maybe seven years or so we've been performing it, is that, building those relations with urology have been challenging and difficult. But, allow educating the primary care doctors, has really proven successful. So, we've used that to really build, and sustain our PAE practice.

 

 

[Michael Barraza]
That's fascinating. I remember, a couple years ago, you had a really cool website advertising the procedure, that was one of the first I had seen. I'm very jealous.

 

You know, you guys brought up an important point, and that's the status of PAE, and the literature, and where it's going. I was hoping you guys could let me know what dominoes still need to fall, from the standpoint of data, besides long term advocacy, before this starts to rival TURP for all routine patients.

 

 

[Sandeep Bagla]
Ari, you wanna take that one first?

 

 

[Ari Isaacson]
Yeah, sure. I think right now, the biggest obstacle that I see, as far as the clinical practice growing, is insurance coverage. We need private payers to get on board, and that's what we're working on right now at UNC. I think what anyone who wants to grow a practice, should be working on.

 

Obviously, there are holes in the data that need to filled, but as far as PAE growing, I think the insurance coverage issue is the most important obstacle.

 

The other thing I should say, is that I don't know PAE will ever become as used as TURP. Some of us want to believe that, but I think PAE is gonna be a definite option for people, and it's gonna have its advantages with certain subpopulations, but I think it'll just be another option, in addition to TURP.

 

 

[Michael Barraza]
Now, Ari, when I was a fellow, when we had these patients, we would do most of the pre- procedure workup, and the follow-up, but I was really impressed with this system that you all developed at UNC. This collaborative partnership with urology, it's both innovative and it seemed to be ideal for both patients, and physicians.

 

Could you share with us how that works, how it got started, and how you guys as a team managed the patient before and after the procedure?

 

 

[Ari Isaacson]
Yeah, absolutely. From the very beginning, I didn't want my interest in PAE to be a threat to urology, I wanted to try to approach it in a collaborative way, and get them on board, so they could see the benefit of it for them in the long run. From the very beginning, when I started the clinical trial, I asked one of the urologists to be my co-investigator. I had every patient who we enrolled in the trial, see urology for about four or five visits, associated with the trial, including a cystoscopy. They're getting a good volume of business from this trial. 
That made it a legitimate treatment in their eyes, and they got to see firsthand the results of it. When patients did better, they were coming in and seeing urologists, and urologists were ... It's hard to be skeptical when you're seeing the patients yourself.

Then, I was able to present all the data, and the background on the procedure, at Urology Grand Rounds, at UNC. That helped spread it as well. Since then, they've become believers, in the sense that they've seen the data, they've seen the patients, so they understand the value of it, and have started sending patients my way.

 

 

[Michael Barraza]
I also thought you made an interesting point, and I visited, that this allows urologists to retain patients, who otherwise might have been lost to follow-up, so they really get to keep their patient population. Getting across this bridge with urology has been my greatest challenge, since I'm not doing any clinical trials, and private practice.

 

Do you have any recommendations for how to approach a urology practice, to push this as a collaborative partnership?

 

 

[Ari Isaacson]
I think Sonny could probably speak to this a little better, because he functions out of private practice. But, I think the key when you're starting out, is to really emphasize the holes you can fill with the procedure.

 

You don't wanna approach urologists, and say, "I have a treatment that's far better than anything else you can offer for BPH.", but rather, you'd wanna say, "I have a treatment that can treat hematuria. I have a treatment that can treat very large prostates, that you may not want to TURP. I have a treatment that can be useful in the setting of coagulopathy, or being on medications.".

 

I think that's the emphasis you wanna go with. Sonny could probably speak to that a little more.

 

 

[Michael Barraza]
Yeah. I'd love that, Sonny. I'd also like to hear, for the patients that you do get from primary care physicians, if you are having them see urology before the procedure.

 

 

[Sandeep Bagla]
Sure. Couple things. Similar to Ari, we've launched our clinical trial back in 2011. We did the same exact thing. Urology was involved, in terms of being an investigator. Not only on the clinical study, but actually seeing and evaluating every patient that we were enrolling, and even screening, for that fact.

 

Similarly, now, almost invariably, all patients who come to us, even through primary care, have been evaluated by urology in some form or another. I think that is important. I wouldn't say that it's an absolute. The same goes for anything that we do, as interventional radiologists, we often times sell ourselves short, as not being able to, say, manage clinical medicine.

 

With, say, for example, a urologic patient, depending on the community you're practicing in, many urologic disorders, specifically BPH for example, are managed wholly by internal medicine physicians, and primary practice physicians, and really only referred to urologists when there is a need for surgical intervention.

 

Whether it's a medical management workup evaluation, et cetera, it is important for interventionalists to really feel comfortable, and knowledgeable, about the entire BPH spectrum, and how to manage the patient, whether it be watchful waiting, whether it be lifestyle modification. I think that the more you feel comfortable managing a BPH patient as a whole, the less you may rely on a patient to see a urologist. That doesn't imply that there should not be a collaborative network, or framework, for how you build a PAE practice.

What's important to take away from that, is that interventional radiologists are capable of managing these patients, both independently, and with the help of both urology, and primary care. I think that's an important concept for interventionalists to really get a hold of.

 

 

[Michael Barraza]
Absolutely. Now, Sonny. The risk of oversimplification ... Is there a typical type of patient that you see pretty frequently? The ones that get referred to you for this procedure.

 

 

[Sandeep Bagla]
Yeah. The ones that typically get referred, are the ones, like Ari mentioned, that we go out and promote to be their urologist, or primary care doctors, that we should be seeing. Those are the patients, like Ari mentioned, who had a recent MI, they're on Plavix, for example, they're not gonna get a transurethral procedure for that reason. The patients have a very large prostate, or have some contraindication to surgery general anesthesia, et cetera. Those are the types of patients, who I think are very typical from the referred patients. The patients that other doctors are seeing, and say, "Hey this would be great for PAE.", because their traditional transurethral surgery may not be ideal for them.

The other patient population that comes to interventionalists, and I think as the procedure becomes more widely recognized, will be directly referred patients. Those patients who come direct to interventionalists ... They're a different patient population, because they themselves are seeking out an alternative option, which is very different from someone, of course, who comes by way of their physician. That type of patient population, is someone who's much more inquisitive, asks numerous questions, would love to have comparative data, and/or a good understanding at how PAE compares to former typical procedures. They're a much more inquisitive bunch. How to handle these two different patient populations is an important skill to learn.

 

 

[Michael Barraza]
For both of you, and starting with you again, Sonny, after the procedure's over, do you see these patients afterward in the clinic, and if so, when?

 

 

[Sandeep Bagla]
Our first followup with these patients is two weeks after the procedure. If they're a local patient, we have them come back in the office, and if they're more remote, or for some convenience factor, we do followup by telephone, then again at four weeks.

 

Following that, it's usually three months, six months, and then yearly after that. The reason for that, is after about a four week period, we generally will see the patients have had a significant improvement from the procedure. From then on out, we want to be involved very closely, in terms of managing their medication, evaluating them to see if they should ever have a reoccurrence, or how significantly their symptoms have been improved.

 

 

[Michael Barraza]
Okay. Ari, is your system similar?

 

 

[Ari Isaacson]
I think so. Like Sonny was saying, if the patient has come ... There's a good percentage of patients that have seen me, that are coming from far away. For those patients, we follow up by phone. For the patients that were referred to me by UNC urology, I have them follow up with UNC urology. I send them back there, and usually it's one or two providers that send me the patients, and they know the things I'm looking for. They send me a notification right away when they see the patients, so I know how the patient's doing. If the patient was sent to me by a urologist outside of UNC, I'll see the patient back myself in my clinic. That's kind of my algorithm.

 

 

[Michael Barraza]
Okay. Now, I know this is different because due to your level of experience, you're going to be the last relying on something like that, but for preprocedure CTA, which kind of patients are you still doing these for?

 

 

[Ari Isaacson]
I'll speak first about that. Let me give you a little history on this, and I'll tell you where I'm at with it.

 

Initially, I got CT in everybody. That's just cause when you're starting out with PAE, one of the biggest challenges is the anatomy, and determining where the origin of the prostatic artery is. I'm not the smartest guy, I'll just put it that way. So, I wanted to give myself the best opportunity to figure out what was going on. That meant having images the night before, looking at them, studying them, figuring out what approaches I was going to use. I was pretty meticulous in doing that, in that, I would create 3-D rendered images, and I would figure out what angle with the eye I wanted to see the origin of the prostatic artery the best. I'd create kind of a map for myself.

 

As I started to grow in confidence, with more volume of PAEs, I tried to make the experience a little more convenient for the patients. Since most of them, at that time, were coming from out of town ... I have to say, I give credit to Sonny, this was Sonny's idea. I don't know if he remembers, but way back, he said, "Why don't you just do a Cone Beam CTA?", and I said, "Alright. Let's see what we can do with that.", so we came up with a Cone Beam CTA protocol. What that allowed us to do, is basically get the same CTA information, but do it on the table prior to the actual procedure. That prevented the need for the patient to come the day before, and get a CTA. It reduced some added expense.

That's kind of my practice these days. I'm just doing Cone Beam CTAs ahead of time, unless there's a patient I'm particularly concerned about. If I think they have bad atherosterotic disease for some reason, or if there's some other vascular issue that I'm concerned about, I will get a CTA. But, the majority of the patients, I'm doing Cone Beam CTA on the table prior to the procedure.

 

 

[Michael Barraza]
Do both modalities tend to give fairly equivalent anatomic information? Can you see shunts, for example, in both modalities?

 

 

[Ari Isaacson]
It's funny you ask that, Mike. We have a paper coming out in January, shortly. Yes, thank you very much. We did a comparison between our conventional CTAs, and our Cone Beam CTAs. We looked at it two ways, objectively, and subjectively.

Objectively, we're looking at the degree of enhancement within the vessels. Subjectively, we had a couple reviewers look at if they could determine the prostatic arteries, and we had a grading scale for it.

 

The way it came out, was the objective measurements were better for Cone Beam CTA, believe it or not. But the subjective measurements, there was no significant difference, although, in my opinion, I think you do see the arteries better on the Cone Beam CTAs. What you lose on Cone Beam CTAs are some of the soft tissue information.

 

 

[Sandeep Bagla]
It's funny. In listening, back to Ari's conversation. Evolution, from going from the preoperative CT, to CTA, he told that story really well. I still to this day, find myself identifying certain shunts, depending on how hard I even inject the prostatic artery, with the microcatheter, and the syringe.

 

I find that there's so much variability in day to day PAE practice, that it's very hard scientifically to prove what we will see better with certain techniques, versus others. As you probably know, and I mentioned to Aaron not too long ago, just the other day, actually, was that I don't firmly believe Cone Beam is a significant value.

 

It takes a lot to say that, I'll be honest, because over the years, having sat on panels, where my colleagues have said, "You know, you should just tell everybody that it's great to use in the beginning. You have to use it.". I'm a pretty traditional diagnostic angiography type of person, and maybe that's just being simple minded, of looking at, these are six, seven, eight arteries you need to be able to identify. When I feel really comfortable with a good digital subtraction angiography, I can, not only identify the prostate, but also really well identify much of the flow dynamics and collaterals, that I don't feel like I will get during a static image, per se, like a Cone Beam CTA or Cone Beam CT.

 

We published, a number of years ago, the Cobalt Cone Beam CT does improve your confidence level in identifying other collateral vessels. It also does lead to a significant number of false positives, so I think, taking in mind the good and bad with Cone Beam CT, overall, if I had to start over ... Frankly, we did do this in the very beginning. We just did the procedure with good DSA, and we used the Cone Beam to confirm. But really, frankly, relied mostly on the subtraction and angiography.

 

 

[Michael Barraza]
Sonny, I'm interested to hear if you use Cone Beam in the same way as Ari. My vast experience of one day with Ari, what really blew me away, was how he was able to take the images obtained on Cone Beam CT, and create these immaculate rotating roadmaps, that allowed very easy identification, and the proper obliquity to catheterize the prostatic artery. That's where I wasted a lot of my time in the past. Are you doing the same thing?

 

 

[Sandeep Bagla]
No. For a number of reasons. One, is I think that while they do produce great images, I think that one of the things you get from a selective run, for example, the hypogastric artery, is that dynamic image. That dynamic image is very important for flow dynamics.

Oftentimes, I think if you get a roadmap, for example, which is not dynamic, and you try to go all the way from position A to position Z, sometimes the problem is you can overlook, or bypass, another vessel, which may have a different ... If you want flow dynamic, then the targeted vessel you've identified.

 

So, we don't do that. Although, I do appreciate the pretty images, and I do use many of Ari's images for my lecture, cause they're always good show stoppers. We don't tend to do that. We tend to just focus on subtraction.

 

 

[Michael Barraza]
What are the hacks of site selection, radial versus femoral? How do you make that decision? I know that there are people who are hoping you say, "Always femoral.", and people who are saying, "Always radial.", but my guess is that the truth lies in the middle.

 

 

[Sandeep Bagla]
I think it does. I've had this conversation with Ari many times as well. I think it's really an individualized approach. Some patients, of course, want what they want, right? They want femoral access, for example, or radial access. It is reasonable, of course, to respect their opinion. However, with a good discussion about what the risks, benefits, and alternatives are, with each access point.

 

At least with myself, having done them both femoral, and radial, and not having the radial experience that Ari has, particularly with PAE, but with other procedures. We typically make our decision, based on not just patient preference, but really based on a number of other things, like for example, the patients' height, patient having significant other risk factors for vascular disease, so we're putting them at significantly increased risk of.

 

Invariably, I would say the vast majority of patients, we still choose to perform it femorally. The reason why, is because, honestly, the system works well for us. We don't run into a situation we have to convert somebody from a femoral access, to another type of access. The procedure time is very reasonable, meaning under 90 minutes, for example, to have the procedure done. While they won't be ambulating for two hours, after the procedure, from a femoral access, they generally are kept anyways for at least an hour for moderate sedation.

 

All in all, we tend to have a system that works well with femoral access. I'm not necessarily against radial access, but I think that it does come with certain challenges, that of course, Ari here will probably be perfect to address what those are.

 

 

[Michael Barraza]
Now, Ari. You told me that the height limit, if I'm not mistaken, was 5'11. Or was it 5'10?

 

 

[Ari Isaacson]
I tend to use 5'11.

 

 

[Michael Barraza]
From either access, femoral or radial, what do you include in your standard diagnostic assessment for PAE?

 

 

[Ari Isaacson]
Are you talking about in your pre-clinical?

 

 

[Michael Barraza]
No. I mean your DSA. You get a catheter in ... What do you consider complete imaging, before going down, and selecting the artery, and
treating?

 

 

[Ari Isaacson]
Oh, I see. I'm kind of belt and suspenders type of person. That means that I wanna see where the prostatic origin is on a CTA, or Cone Beam CTA, but then I'll wanna confirm that with angiography. I'll put a catheter into the interiliac, and try to position it ... Ideally, I'd love to position it where I'm just seeing the anterior division, but sometimes that's not possible. I'll do a hand run from there. A pretty robust hand run.

I'll try to hold it out until I can make out the prostate. Usually, that is adequate. The problem with that, and I think you alluded to it earlier, Mike, is that you can often, almost all the time, you can see the prostatic artery pretty easily with that run. Sometimes it's hard to see the angulation, in which the orifice of that artery arises. That's kind of the challenge that I find, and I think Sonny's really good at that, cause he's done so much of this type of angiography, but that gives me challenges a lot of times to catheterize it.

 

I kind of like having the combined information of seeing what angle the origin comes off of, and also having the angiography as well.

 

 

[Michael Barraza]
So Ari, you found the target artery, and you found the angle. What do you typically use to select it?

 

 

[Ari Isaacson]
It depends if you're asking femoral, or radial. My catheters, I tend to use microcatheters, are either Progreat, a Direxion, or a Sniper catheter. Those are the three that I tend to use. My initial wire that I start with, is a Fathom-14.

 

 

[Sandeep Bagla]
My typical go to catheter is probably very similar to Ari. The Progreat Catheter 2.4, I may use a 2.0 in very small glands, for example, less than 55 CCs or so. The Direxion catheter I typically use with reverse angled origin prostatic arteries, because it's a very nice, pre-shaped catheter.

 

As far as go to wires, I use the double angled Glide wire. I think it works in the majority of cases. If that doesn't work, my secondary wire is an 0.014 Transend wire.

 

 

[Michael Barraza]
Okay. I know you guys have provided us with plenty of reading material, and the different wires you can use, including the SwiftNinja, I know Ari, you told me you liked the Sniper catheter to minimize non-target embolization. What is your algorithm, from going to a different catheter?

 

 

[Ari Isaacson]
The first thing is, from radial, you have lesser choices, right? You need a catheter that's at least 150 centimeters. You're looking at a Progreat, a Direxion, there's a Maestro that's available, there's a Cook Cantata, so there's a bunch of different microcatheters that are available for that.

 

Initially when I started, I really liked the Direxion a lot because of the angulation, obviously, and it helped. I think, since then, I've come to rely more on my wire skills to get into some harder arteries. I'll start with the Progreat, which is straight.

 

As far as from the femoral, I've been using the Sniper a lot lately. This isn't something I recommend, that everyone go out and start using it, cause it is a whole different kind of concept. It's a Balloon Occlusion Catheter. It changes flow. I have some experience with it, so I kind of know what I'm looking for in doing so. I think it's not quite ready for everyone to put their hands on and start using quite yet, but I think there's some potential there, that we could demonstrate some benefit of using Balloon Occlusion for PAE.

 

 

[Michael Barraza]
Okay. Let's take a step back, to where we've just selected the prostatic artery. There's no way we can get through all the anatomic complexities and everything like that. But, generally what are you looking for to allow you to treat at this point, and what findings might lead you to change your plan?

 

 

[Ari Isaacson]
The patients that I get excited about, I'll start with that, are patients with really large glands, so patients with 80 Ccs and above. I consider those pretty large. I like younger men, who may not have as bad atherosclerotic disease, so that's helpful also. As men grow older, I think the arteries tend to become a little more tortuous, which can hurt you as well.

 

I think the number one thing that can make PAE really tough, is having very tortuous pelvic arteries, like the iliac artery, cause if you have to wind through some pelvic tortuosity, it takes away some of your control of your diagnostic catheter. Those are the things that, initially, I get excited about. 

 

The patients that I would consider not doing, first of all, I would strongly, strongly warn people about attempting this on people who are known vasculopaths. You're setting yourself up for badness.

 

 

[Michael Barraza]
What in particular do you mean by vasculopath?

 

 

[Ari Isaacson]
One screening question that I ask people, is, "Have you ever had any issues with coagulation? Have you ever had a bypass graft in your leg? Have you had any stunting in your legs?", things like that. If they say yes to any of those, I'll get some imaging first, but I'm leaning towards not doing a PAE on them.

 

The other thing I would say, is if they have a small gland, and I say small, it's probably less than 50 CCs, so somewhere in the 30s or 40s, and a pretty prominent median lobe, that worries me, because I feel like we can't get enough action on the median lobe itself, to alleviate the urinary symptoms. 

 

When the prostate's globally larger, you affect the lateral lobes a lot, as well as the median lobe, and I think you can get a better effect. But, when it's already a smaller prostate to begin with, I worry about those patients.

 

 

[Michael Barraza]
Okay. Now Sonny, let's get into the embolic agents that you use for a second. Tell us what you use, what's your endpoint, and how LUMI beads might be able to change how you embolize the gland?

 

 

[Sandeep Bagla]
Sure. Over the years, I think early on we were using beads and back in 2011, we were using beads that started out in size around 250 micron. We were then finishing with embolic that was in the 400 micron size. When we were using Embozene, which at the time was made by Celenova ... We still use Embozene, however, we have gone smaller in size. About three or four years ago, switched to smaller size, starting almost invariably at the 100 micron size. Then, upsizing as we reached stasis.

 

The reason why we did that, is because early on we saw a relatively disproportionate number of early occurrences, and whether it was just our feeling or not, we just felt as if we didn't get enough tissue ischemia, and deep penetration with those beads. There's no doubt that smaller beads cause more ischemia, but they of course come at a risk of potential non-target embolization. As long as we were comfortable with the angiogram, and thought that there was no risk for non-target embolization, in terms of flow dynamic, and appearance on the angiogram, then we invariably, even in very large glands, start with smaller size beads, and then upsize accordingly so that we can take out what we consider primary, secondary, and tertiary branches within the process.

 

 

[Michael Barraza]
Now, assuming you're not using the perfected technique, what is your end point typically?

 

 

[Sandeep Bagla]
One quick thing unperfected, I would say from time to time we do use it, I think that overall though, however, if you're using a smaller bead size, it really achieves the same effect that you would from the perfected technique because of course you're going to get more distal penetration with the smaller bead than you would larger.

 

Invariably, the perfected technique is not necessarily feasible on a good number of patients, who are 30% to 40% of patients, just because the tortuosity of the vessel, and being able to advance your catheter. We place our catheter at the prostatic capsule, if not closer, and we embolize to complete stasis.

 

There's no doubt, when you're doing a prostatic embolization, you're really aiming to take out the whole organ, more than you are, just like an HCC, for example, taking out a small liver tumor within a very large liver.

 

 

[Michael Barraza]
In terms of shunts, and unexpected profusion of the rectum or the bladder, what findings there are okay to go ahead and treat?

 

 

[Sandeep Bagla]
I'm gonna wanna plug stream, but I'm gonna use this opportunity, too. I think that, obviously, for myself, and Ari can cover a number of these things. There's invariably, myself and Ari, and I'm sure I could speak for him comfortably with this, is we would of course feel more uncomfortable having non-target embolization to penile arteries, versus rectal arteries, just because one would be invariably noticeable to the patient, versus the other.

 

That being said, there are so many variations of potential non-target embolization that have to be addressed during the procedure. Something that we see every week, I will tell you, even like Ari said, "Excited about seeing a large gland.". Just on Friday, doing a large gland embolization, you walk in, you're all confident, and you end up with a potential non-target that you have to deal with. That happens with even the simplest of cases. There's such variability here, I don't know if it will be easily summarizable. I don't know if, Ari, you have a different opinion?

 

 

[Ari Isaacson]
Yeah. I think the thing that you need to keep in mind, especially people who are new to PAE, or considering starting, is that there are these extraprostatic anastomoses in nearly every case, and if you don't see it initially, if you do another angiogram after partial embolization of the prostate, you'd probably see it.

 

You do have to be cognizant of that. I think if you don't look for the shunts, and you just embolize to stasis, and you're using smaller particles, you're going to get yourself in trouble. It's important to do good angiography, and identify the shunts ahead of time, and come up with a good management plan. Again, Sonny and I will talk about the different options for managing those types of things at Stream.

In general, like Sonny said, penile shunts, penile collaterals, are the scariest, and the last thing you want to do is give a patient a skin lesion on their penis, or cause them to have less erectile function than they had before. That's definitely something that can deter a bunch of men from wanting to have a PAE.

 

If you have non-target to the rectum, the rectum, as you know, is a very vascular organ, and you may get some short term hematochezia but most of the time that resolves within the first week or two, and usually there's no other sequelae of that, so at all costs avoid embolizing the penis. I wouldn't say don't embolize the rectum unless you have to, or if you do, do it with larger particles.

 

 

[Michael Barraza]
Of course we don't have time to get into all the complications, but focusing on acute urinary retention, which appears to be the most common, when do you see this, and how do you manage it?

 

 

[Ari Isaacson]
I would say that I don't see acute urinary retention ... Are you talking about post-PAE?

 

 

[Michael Barraza]
Yes.

 

 

[Ari Isaacson]
Okay. I would say that I don't see it quite that often. All of the Chinese studies tend to report acute urinary retention at a higher rate than the studies out of Europe and US and South America. I think it's because they tend to use smaller particles, and they also tend to hospitalize their patients for several days, or a week, after the procedure. I'm not sure what the hospitalization has to do with it. It may just be the smaller particles.

 

I only see acute urinary retention when patients are already kind of on the brink of it. For example, if they've already had two or three episodes of needing a catheter to urinate. I'm very concerned about that patient, and I'll usually catheterize that patient ahead of time. The rest of the patients I don't catheterize.

 

I guess the management is that if you have a patient like that, that is either in acute urinary retention, or has had several episodes of it previously, we'll place a Foley ahead of time. Then, we have the patient follow up, probably two weeks after the procedure, if that's acceptable to them. Sometimes they wanna come back a week afterward, which I think they're probably less likely to pass a Trial of Void at that point, but I try to accommodate their needs as best I can.

 

So either a week, or two weeks after the procedure, we do a Trial of Void. If it doesn't come out, then they come back two weeks later, and we try again. That's kind of how we go until we get the catheter out.

 

 

[Michael Barraza]
What do you tend to see more frequently?

 

 

[Ari Isaacson]
As far as post-PAE complications, or adverse events?

 

 

[Michael Barraza]
Yeah.

 

 

[Ari Isaacson]
I would say the most common thing you're going to see, is what I would consider post-PAE syndrome, which would include urinary urgency, frequency, some degree of dysuria, some patients will have some degree of pressure or pain in the pelvis. Those are probably the most frequent things. The other things that you will see sometimes, rarely, or not as frequently as those others, is hematuria, hematochezia, hematospermia, and that's pretty much it. That's the great thing about this procedure, is that the side effects are pretty mild, and rare.

 

 

[Michael Barraza]
Particularly in comparison to the complications of surgical management, that makes a lot of sense. In the interest of time, I was gonna run through one more question before we really start to get into Stream, and this came from one of our Twitter followers who asked mainly just about the current status of insurance coverage, and reimbursement for the procedure, which we touched on briefly in the beginning.

 

 

[Ari Isaacson]
I can speak about this in the Chapel Hill area, and then Sonny can talk about it up in Virginia. We are pretty much having problems with all private payers reimbursing at this point. We're working on some negotiations with them to try and work out a deal, so that we can treat more patients, but right now insurance is an issue for us.

 

 

[Michael Barraza]
What about you, Sonny?

 

 

[Sandeep Bagla]
Yeah, so we're having a better road than Ari is. A number of the private payers pay for PAE, and there's no doubt that in some of my peer to peer reviews with some of the physicians on the other end, having an FDA approved product has swayed them, in terms of the willingness to approve the procedure. It does, of course, require a peer to peer conversation with the insurance company. I think that's been a challenge. But, the major carriers definitely do have some policies again PAE. I think that is, unfortunately, an achilles heel that will not be overcome very easily. I think it will, unfortunately, limit widespread adoption. I think it's gonna take a number of years, frankly, before that changes more universally

 

 

[Michael Barraza]
Well guys, this has been an exceptional summary of how you guys approach PAE. I'd like to devote the remainder of our time to your upcoming conference. You put together a remarkable program, in terms of content and contributors, and the time is also convenient because it's a one day conference on a Saturday, which is much more manageable for people in full-time positions, and it's a very reasonable fee.

 

Could some of you just tell us about the purpose of the conference, and what it offers for IR as various levels of experience for PAE?

 

 

[Ari Isaacson]
What Sonny and I aimed to do, was create as robust of a one day program as we could, and it's really for people who are at the very beginning of their PAE practice, or considering starting their PAE practice. We really wanted to cover it from all angles. We didn't wanna just do what catheters and wires are you using, or what kind of imaging do you have to get ahead of time. We wanted to also look at it from a legal standpoint, from a program building standpoint, we wanted to have urologists speak, we wanted to have some time for people to do question and answers with us individually. We really tried to build a curriculum that will leave an attendee with the confidence that they have a good foundation for going back, and starting a PAE program.

 

 

[Sandeep Bagla]
I feel like, and I'm sure Ari feels to some degree this is true, when you go to other meetings, which are dedicated to a wide variety of topics, you don't really leave feeling trained on PAE. You may feel like you got an update on the literature, or a little bit about anatomy, a little bit about what's coming next, but really, in order for people to leave well trained, and feel comfortable, I think you really have to cover a wide variety of topics.

 

Even down to whether or not the procedure is performed in an outpatient lab, versus a hospital. We have M&M cases where we share our complications. I think all these things will allow whoever comes to leave with that level of confidence that we want. Ultimately, myself and Ari, want this to be very widely adopted. Not just safely, with great outcomes, but we want the physicians who are performing, the interventionalists, to really be the leaders in the field performing this procedure.

 

 

[Michael Barraza]
Gentlemen, is there anything else you guys would like to add?

 

 

[Ari Isaacson]
Did I say Stream was going to be strong this year? I think it will be a big relief when it's over.

 

 

[Sandeep Bagla]
It will be a relief for both of us. That will be the name once in the morning.

 

 

[Michael Barraza]
That's right. Once in the morning, and that's it. No more getting up.

 

Ari and Sonny, look, let me take this opportunity to offer my profound gratitude to both of you for joining us today. This has been an enlightening discussion, with invaluable content for IRs of all levels of training. I look forward to seeing you both at Stream.

 

For listeners, thanks for sticking with me for another episode. We're thankful for your support, and we're always interested in feedback about what you wanna hear, and what we can do better. Reach out to us on Twitter, using the handle @_backtable. We'll catch you on the next one.
 

 

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