Advancing outpatient embolization: navigating PAE, GAE, and the road to broader access

Episode Transcript

Recorded live from Cook Medical and featuring leading experts in the field of interventional radiology discussing a wide range of IR-related topics. This is the Cook@ SIR podcast series.

Hey everybody, thanks for joining us today. My name is Dr. Kavi Devulapalli. I’m very thrilled to be on the Cook@ SIR podcast series to talk about genicular and prostate artery embolization as it pertains to the outpatient space. I’m excited to have this conversation with Dr. Jerry Niedzwiecki. Dr. Jerry needs no introduction, but for those who may not be familiar with him, Jerry, you want to go ahead and let the audience know who you are?

Sure, thanks, Kavi. When Cook came to me and said, “Hey, can we do a podcast,” you were the first one who came to mind to discuss these topics. I know you’re well versed in these topics.

Myself, just a little bit about myself. Practicing in Clearwater, Florida, I have had an OBL since 2005. I was the past chair of economics at the private practice counselor at SIR and the RUC representative for SIR for a number of years. I’ve more recently have been the past president of OEIS, a founding member of OEIS, and currently run the annual meeting. So I’m going to put an unabashed plug in for everybody to become members of OEIS. And it doesn’t matter if you’re listening to this in 2026 or 2036, you should become a member. So Kavi, you want to do your introduction?

Absolutely. Well, I think that’s wonderful. OEIS is very important. We’ll be talking about that a little more too as it pertains to some of the topics that we have for you all today.

But I’m thrilled to do this with Jerry. I’ve learned a lot from Jerry over the years. I’m an interventional radiologist about eight years out of training in Columbia, Missouri. I got very involved in the outpatient space probably about six years ago when I actually met Jerry’s contemporary, Bill Julien, who’s also a founding member of OEIS, and soon thereafter met Jerry and really learned about a lot of the magic that we can do in an outpatient environment.

And it’s pretty remarkable how far we’ve advanced even in such a short period of time. Of course, Jerry’s been doing this as one of the first in this space for over 20 years at this point. But even during my short time, I feel like we keep innovating and we keep doing new things. And as part of my practice, I’ve been heavily involved in both prostate and genicular artery embolization, and these are things that were relatively new when I was training not too long ago. So it’s been very exciting to get involved. Definitely encourage everyone to get involved in OEIS. Learned a lot from the society.

But I want to spend some time and kind of hone in on some of these topics because I think it’s on a lot of people’s minds. I think there’s a lot that both of us have learned over the years doing this. So the first thing, Jerry, that I’m kind of about is why are GAE and PAE great procedures for the outpatient space? Specifically OBLs.

Well that’s a good question, Kavi, and I think you share some of this. We’ve been doing fibroid embolization in the outpatient setting for a long time. In fact, I harken back to the days long ago when that was an inpatient procedure, keeping the patients overnight and so forth, and there was a lot of hand-wringing about being able to do these procedures and send the patient home the same day. We finally figured out the correct mechanisms for that, and now UFE is done pretty much, I would say almost universally, as a same-day discharge, whether it’s done in the hospital or an OBL. Patients really I think love the OBL setting. It’s easy to navigate. You’ve got a hand-selected crew that you’ve got working in your lab who make it a very inviting and homey space for patients, and I think they truly enjoy that.

PAE obviously has been the next iteration, as well as GAE. And we’ll talk about, I think in the future of this podcast or later on, some of the problems with reimbursement that we’re facing in all of these arenas. But even chemo embolization these days, I do in the OBL and send patients home. So I think there’s a lot of reasons that the OBL is very attractive for this, and that’s all on a patient side. From a physician’s side, I get to use the things I want to use. I don’t have to go to the VAT to say, “Oh, I want this microcatheter. I want this wire.” If something comes in, I can use it, because it’s my lab. So the OBL is really, I think, well-tuned to this and there’s a tremendous amount of physician satisfaction in that OBL setting. So I don’t know.` What are your thoughts, Kavi? What do you think is driving this to the OBL?

Yeah, I share a lot of those thoughts. I think for me, what brought me as a physician to the office was the ability to do what I love doing, which is doing these amazing procedures and being able to provide longitudinal care. And I think that’s something that’s inherent in the office. And I think what goes along with that are advancements in technology, including these new procedures, PAE and GAE. I think for me, I definitely agree on the patient side, it’s more convenient. I think for physicians, it’s not only more convenient, but we get to do what we want and have autonomy over our practices, which I think in turn results in better patient care. But I also think too, from a societal level, we’re able to improve access for a lot of patients. A lot of hospitals are overburdened. Especially after COVID, it’s been really hard staffing beds, shortage of IRs, and being able to offer elective procedures that have the ability to impact millions of patients. Especially with PAE, we’re talking about over 50% of men over the age of 50. Patients need a place to actually get treated. And I think we’re able to do that.

So it’s kind of the perfect intersection of proving our careers, patient lives, and actually doing a benefit for society. In terms of access and cost of care, we’re able to do things more efficiently and cheaper. So that’s ultimately good for the taxpayer and it’s good for everyone. So I think for me, that’s kind of what’s done it.

I think with prostate specifically, I definitely echo a lot of what you’ve said. Being able to use the supplies that you want to use, I remember that was a big struggle for me coming out of training and having to deal with those product committees and trying to convince non-interventionalists about what we do. So definitely a big thing. And I think even with GAE, this is making sense too. I think it’s a lot of the same themes. Definitely agree with that.

Kind of thinking about patients, however, and everything we can do, let’s talk about patient selection and maybe some clinical outcomes. So for those who may not be as familiar, they can get a better idea of what these procedures are like. So who do you think benefits most? Let’s start with PAE. What do you think about PAE? Who do you find is best suited for this procedure?

There’s the patients who are best suited and then the patients who are best suited for the interventionalists, right? Give me a 400 gram prostate with a guy who has a weak stream, and he’ll be cheering me from now until cows come home. I would say that that’s the ideal, but from a proceduralist standpoint. From a patient standpoint, as you have pointed out on the IPSS, there’s the storage problems and the flow-related problems, and obviously what we’re talking about is shrinking the prostate to allow greater outflow, if you will, and those obstructive symptoms are the ones that I think are going to benefit the most.

Having said that, I will tell you I have patients who are so happy. I was honestly surprised. I will tell you, I’ve gone to SIR multiple times and I’ve heard multiple lectures in the past on PAE, and I was just kind of shaking my head like, “Yeah, yeah, sure, sure.” But once you start doing these, the patients are so appreciative. These are some of the most appreciative patients that you’ll ever find, and I’m even including patients with CLI. Their life is so affected by their disease process, but take a guy who is getting up six times a night to pee, and he’s grumpy because he’s not getting any sleep. And if you can do something for him, they’re real happy. So the patient satisfaction is really, really very high for this. But I don’t know. When you do these, Kavi— I’ve seen patients who get sent to me with 35 gram prostates, and I kind of shake my head, “Do I really want to do this?” But do you have a particular cutoff that you have for size of prostate that you’ll do?

It’s a good question. I tend to exercise caution under 50. I still offer it. There’s certain patients who I know would benefit, but I’m just a little less enthusiastic about it. And I think one thing that I’ve kind of learned is that, as you mentioned, there’s a lot of etiologies for BPH— for LUTS rather. And BPH is just one of those etiologies. So I think one thing I noticed is as we get smaller, you want to be able to really eliminate any confounding factors. And I think technically I’ve done small glands before. I’ve done them as small as 30, and this is a histological diagnosis, so you can still have histological BPH even though the gland is not large. But I just question whether or not embolization is necessarily the right procedure in those settings. Oftentimes for smaller glands, if we do think that it is BPH is the reason for LUTS, we may consider talking with urologists about other procedures. Even something as simple as an in-office UroLift® could be really good for smaller glands, but I’m just a little hesitant. I think 30 is the smallest I’ve done, and I’ve had some success stories, but I’ve had some as well that maybe they just didn’t get the best treatment outcome that I would’ve liked. So a little variable.

Yeah, I agree with you. The smaller the prostate, the more you sort of ask yourself, “Is this really causing obstruction that’s causing all of the problems or are there other issues that are going on?” And then even with prostates that are like 50, 70, 80, 100 grams, and I would say my average is probably about 120 gram prostate is kind of generally what I see, those patients with the median lobe enlargement, what’s your thoughts regarding— What do you tell somebody if they come in and the urologist says you have an enlarged median lobe? Do you tell them no? Do you tell them yes? How do you set the expectations of that patient?

It’s a great question. Median lobes are so hard, and they’re really hard for urologists, especially. They don’t have a lot of great options from a transurethral approach. So oftentimes we tend to be a last hope for many patients.

Very cautious with median lobes. I still offer the treatment, but what I tell patients is it’s very important that we actually get the blood supply going to that lobe. And it’s pretty fascinating, as these glands get larger it’s not surprising to see arteries that specifically go to the median lobe. And there are situations where we do need to isolate that artery and we need to get a good volume of embolic in there. I typically shoot for outcomes that are similar to patients with non-median lobes, but I think sometimes you can get in trouble. You may not get the kind of ischemic effect you would like in the median lobe. You may potentially run the risk of relatively short-term complications, but urinary retention in median lobes. That’s possible. There’s a ball valve effect that can happen.

But I think now that we kind of understand PAE better than maybe what we did 10 years ago when this was first really brought to market and described and made popular, I think we have strategies now to really treat those patients. So I embrace it, definitely, but I take probably longer during my procedures to treat those patients to make sure we get good coverage of that area.

Yeah, and I agree with you. And it’s difficult from a matched expectation standpoint when I see them in consult, I’ll tell patients just because you have a median lobe doesn’t mean this is going to fail— a hypertrophic median lobe doesn’t mean PAE is going to fail, but in those patients who don’t respond, there’s a higher percentage of median lobe hypertrophy. So it’s working against you. And I’m just trying to match the expectations because patients have done a lot of work with Dr. Google about PAE every time they come in, and they’re quoting information to me all the time. And I just like to make sure that their expectations are matched to what we can produce for them.

Definitely. Got to love Dr. Google, right?

Yeah.

No, I think that’s good. And it’s good. With PAE we have a lot of good data. We have randomized trials, and we know what to expect. We know how to embolize these glands. We know their satisfaction is related to us physically shrinking an organ, which is it’s very satisfying. As you mentioned, it’s a lot of analogies to UFE in terms of theory and outcomes, which is good. That’s something that we know very well. But I want to take a minute and kind of shift to something a little different. Genicular artery embolization. Not necessarily organ ischemia, but still an embolization procedure. Is this something that you’ve been taking on in your practice?

I’ve done some but not as much as PAE. And partly the reason we’re going to talk about this is reimbursement in my area, the insurance companies just don’t want to pay for it. And we can talk about the ICD-TEN CPT mismatch with selective catheterization codes and so on and so forth, and we’ll get into that I’m sure later on. But that really limits what we can do sometimes. But I do think GAE has really changed the landscape of management of arthritic pain, especially for those patients with moderate to more mild arthritic changes as opposed to severe bone-on-bone. But it’s interesting, and this may be something that will be discussed, I’m sure ad nauseam at some of the upcoming meetings, is it when you— With the use of imipenem, and I think imipenem has made this so safe a procedure now, as opposed to getting non-target embolization with permanent particulate, is imipenem an embolization or a drug delivery? And I personally believe the imipenum is being used not as a drug, but as a embolic, a reabsorbable embolic. And so if you had a reabsorbable embolic, you might not use imipenem. I don’t know. What are your thoughts regarding that topic?

It’s a good question. I think there’s a lot of uncertainty and controversy about GAE, and I think it’s a reflection of the fact that there’s still a lot that we need to learn. I think the early experience with imipenem has been remarkable. With Okuno and subsequent trials, we’ve had some really good results shared in research, and imipenem is something that I’ve gravitated to. I thought it was super interesting the first time I learned that if you mix this drug, this antibiotic, with contrast, you actually make particles somewhere on the size of 50 to 70 microns— crystals rather, that actually function as embolic agents. So to that effect, I agree with you. I think the point of imipenem for musculoskeletal embolization is it’s really an embolic effect. It’s not necessarily the fact that we are giving a drug or administering a pharmaceutical. It just so happens that we’re creating crystals out of a medication.

So it’s really fascinating. And what also fascinates me about it is the fact that it’s a temporary embolic. That somehow when we inject these crystals into the arteries that go to the synovium, we create a treatment effect and it helps with pain, but it’s not a permanent embolic. Yet, the treatment can persist for one to three years potentially, which is really fascinating. So it’s fascinating and confusing at the same time.

And also it seems to have some selective effect for inflamed tissue. It seems to aggregate at inflamed tissue, which even now makes it an even more interesting embolic agent because it’s now having this effect selectively as opposed to through moving through normal tissue.

Right, exactly. It’s kind of mysterious. So I think realizing what we’re dealing with with the temporary embolic, certainly the safety profile is less harrowing and safer than thinking about what it would be like with permanent particles. I think there’s a large question as to what type you should use and kind of even taking it a step back, I think it raises a lot of question about who we should treat. And patient selection for GAE, for me personally, has been one of the most challenging things. I think for PAE it’s been relatively clear cut, and we’re probably a decade further with PAE when it comes to research than we are with GAE, but I’ve taken on more GAE and really because there’s a need for it.

It’s actually funny, I haven’t really gone out and marketed it. It kind of just seems to come to me because patients are learning about it, and orthopedic surgeons and sports physicians are learning about it, and osteoarthritis is so common and so hard to treat that it’s something that has become a reality. And I think for me when it comes to patient selection, it’s been mostly patients with mild to moderate arthritis that I’ve noticed the biggest benefits for. I haven’t had much success in severe arthritic pain, and I kind of wonder if that’s related to the inflammatory effect in a knee being almost burnt out. But there’s been variability. I have friends in our community who swear by it for all severities of osteoarthritis. So what are your thoughts on that?

Well, actually, I was going to follow up, I’m not going to let you off the hook yet. I want to hear what you have to say about patients with post-knee-replacement pain and GAE, because is this a synovial effect or this similar to a native knee pain? What are your thoughts?

Yeah, I have a hard time conceptualizing that, but I’ll tell you what has worked for me is definitely hemarthrosis, there’s no question. If we prove hemarthrosis in a post-knee patient from a tap, I feel like GAE has been very successful. I’d probably say 80% to 90% success rate. It’s kind of this post-inflammatory state after a total knee still been pretty successful. I think for me, anecdotally, this has probably been a vast majority of my patients to this point. Maybe not quite as successful as the hemarthrosis. And I’ll be honest with you, Jerry, I don’t really have a great handle on it. I think we presume that it’s related to inflammation after surgery, but it’s really hard to say. I think a lot of patients we do notice blush in the expected location of the knee joint around the hardware. It’s actually quite remarkable. A fair number of those patients even without hemarthrosis seem to respond pretty well to treatment. I think based on that, I am thinking there’s definitely inflammation going on, but it’s a mystery to me.

Yeah, I echo that. Some of the patients come in that we do, and they’re post-surgical patients. And they can be actually months removed from surgery; it doesn’t have to be in the immediate and post-operative timeframe. And I kind of scratch my head sometimes and wonder why is this as effective as it is in managing that pain? But you mentioned hemarthrosis, and I want to pivot for a second, if you’ll allow me to. Hemarthrosis is probably one of the reasons you can get paid for GAE, right? Because it’s an embolization. And so there’s CPT and ICD-10 synergy. What have you seen, and I was curious when you were talking at your area that you’re doing a lot more GAEs. Are you having a difficult time getting reimbursement? And then I think we can talk a little bit about PAE reimbursement too, but what’s your thoughts?

Yeah, for sure. I think it’s a good question because that is literally the question on a lot of our colleagues’ minds. It’s a big one. I think I’ve been fortunate here, but also we’ve had good planning on our end, as we’ve only been offering this on patients who’ve either had total knees, or a history of hemarthrosis after a total knee, or patients with osteoarthritis native knees but have straight Medicare, not necessarily Medicare Advantage plans. And it’s really fascinating because hemarthrosis, as you mentioned, covered indication, not a problem. This treatment is highly effective for that. But for post-op knees without hemarthrosis and in native osteoarthritis, a lot of commercial plans will view this as experimental, just as they will view analogous pain procedures that a lot of IRs do as well, including nerve blocks and nerve ablations, as experimental. And my suspicion, and of course you are the guru on this with your experience at the AMA level, but Medicare doesn’t have an official policy guideline for pretty much any embolization we do. And in fact, I looked this up, I don’t think it’s been updated since 1978, which is why I suspect that we’re probably getting paid for it for straight Medicare.

Yeah, I think that this is one of those “don’t ask, don’t tell” situations.

Right.

But I agree with you. The only time I have gotten kick out for GAE with straight Medicare patients, and I have alluded to this before and maybe I can expound upon it a little bit, is the ICD-10 CPT code mismatch. So the embolization code does not have actually a specific ICD-10 diagnosis that will kick it out, if you will, but the selective catheterization codes— so when you do an embolization, you use selective cath codes.

If you look at the acceptable ICD-10 diagnoses for the selective catheterization codes, they’re all about peripheral arterial disease. Nothing is about osteoarthritis, knee pain, so on and so forth. So if you bill the selective catheterization code, you don’t have an ICD-10 code to support that and the claim gets kicked out. And so some people are not billing the selective catheterization code and just billing the embolization code and getting paid the embolization code. And of course this is 37242, not organ infarction. This is vascular malformation, if you will, arterial embolization. So at least that’s what I’ve seen as far as GAE goes.

Kind of pivoting into PAE. I agree with you, this is a problematic with the Medicare replacement plans. Some of them do pay for it, but a large percentage of them will not pay for it, calling it experimental. Now, it’s interesting because people will say, well, if Medicare—”red, white, and blue” Medicare—pays for it, the Medicare replacement plans are supposed to pay for it. That is true. If there’s a national coverage determination, an NCD. There is no NCD, as you alluded to, about embolization. There is no NCD about PAE. You can also try to see if there’s an LCD for “red, white, and blue” Medicare, but there are no LCDs for PAE, I don’t think, in any of the MACs across the country. So it’s interesting, and some questions have been posed about, well, maybe we should try to get LCDs. And I think it raises an interesting question.

Right now you’re getting paid by “red, white, and blue” Medicare. What is the database, the status of the literature? Is it so strong that nobody could deny making a positive LCD for PAE? Or is there just slightly enough risk there that you could get an LCD of non-coverage? Aand then that would just destroy PAE, right? So I don’t know what the right answer is, but it’s interesting politics, if you will, trying to figure out the way to thread this needle.

It is interesting politics, and I think for listeners out there, I think it’s all the more reason that you should be plugged into societies like OEIS, because these are things that we work on all the time. And I worry, Jerry, I worry as more Medicare is privatized through Medicare Advantage or these Medicare replacement plans, I worry that we reduce patient access, especially for procedures like prostate embolization, which have good data. But certainly the risk is there, and it’s a tough call. It’s definitely a tough call.

I’ll tell you myself with PAE, I’ve definitely have had some struggles with reimbursement even though we have level one data. We have comparative data, comparisons with TURP, multiple trials at this point, and even AUA guidelines, which give it a recommendation. So despite all that, we still have some issues with it. We have some commercial payers who won’t cover it. We have some Medicare Advantage plans that don’t cover it. And then like you said, you’re kind of stuck if you don’t have some kind of national coverage determination guideline to support you. So it’s a problem and it’s something that I guess we’ll have to figure out a solution for as more and more patients end up with these Medicare Advantage plans. Have you had any challenges on the PAE front yourself?

Very similar. We have some Medicare replacement plans that deny us, others pay, and then private insurers, there are a couple who just— Forget it. They deny it across the board. And we have a lot of patients who are complaining to their insurance companies. And I tell them, “Write a letter and tell them why you’re leaving that insurance plan and going somewhere else,” because they need to know that their policies— patients are noticing. So I think that it is a difficult thing.

And this harkens back to the days of UFE when insurance companies weren’t paying for it, and we had to fight all kinds of battles over and over again, and now we don’t have to fight those battles. So at least I haven’t had to fight that battle in a number of years, so hopefully nobody has for a while. But PAE is in that same formative stage of trying to get the data or get the insurance companies to acknowledge the data. And I think that’s really what it is. They have to acknowledge it. And it almost has to be insurmountable data so that they can’t say, “Oh, no, no, there’s not enough data here for us.”

And then reimbursement— Oh, I am going to put in one plug here for OEIS. SIR does a very nice job of supporting procedures, but OEIS— I really do think anybody who’s doing outpatient procedure, it doesn’t matter if it’s an OBL, an ASC, or the hospital outpatient setting, if you’re doing outpatient procedures, OEIS represents you. And I think that one of the things that OEIS does is because we’re a nimble society. So some of you who are doing PAD work— Neridian just recently had issued non-payment for the PAD cases other than in the hospital setting, and no other society responded to it. We responded, OEIS, very rapidly, and within a week, Neridian reversed its course and said, “Oh, this was a clerical error. We’re now paying for these in the OBL and reprocessing all of the claims.”

And you alluded to the fact that we are a society that tries to think what problems do we need to head off in the future and what do we need to do to strategize to be able to make payments successful in these arenas like going for LCDs, or making appeals to insurance companies to reverse their policies, and so forth. So we need strong people in the society and the more people that we represent, the louder our voice is. So becoming a member and becoming involved in the society is really important. And that’ll be maybe the last for a little bit commercial I give for OEIS.

Maybe. We always got good things to say about OEIS for sure.

Well, I guess as we get closer to the end here, there’s a couple other things that I kind of wanted to get your opinion on. And there’s one thing I want to talk about in particular for PAE, and I want to talk about equipment and specifically imaging equipment. What are your thoughts about cone beam CT? I’m curious.

So I have a fixed unit, and I have cone beam capability, and I do not think it’s necessary for PAE. I think early on, it is helpful. So if you have any doubts, are you in the prosthetic artery or not, it can help with that, but it is certainly not something that needs to be done.

I will tell you, of all things that I use that I think are a game changer for being able to do PAE efficiently is road mapping. If you have roadmap capability—, I just did two PAEs today, and just having that roadmap there, it allows you to actually see the wire shape relative to the wall and see, do I need to reshape the wire, make a larger curve in it, so on and so forth to be able to select that vessel. So to me, cone beam, I just do not think it’s necessary. I don’t think it should be considered the standard of care. And I think there are plenty of people who do PAE very well who don’t use cone beam.

I completely agree, and the reason I was curious about your opinion is because I know that there’s a lot of IRs, maybe some of our friends and colleagues listening to this who may feel limited, and especially in the outpatient space, if you’re like me, trying to keep your costs low, you don’t have cone beam. And I certainly don’t. And there may be some thought out there that, “Well gee, you can’t offer this really good treatment without it.” And I just want to encourage people that you can.

I think from my experience, cone beam has been kind of like training wheels. It’s nice to have, but eventually you’re going to take them off and you’re going to roll on two wheels and be just fine. And I think there are ways to mitigate it. I think having potentially a proctor watching very experienced operators do this case and being very familiar with the anatomy ahead of time through a CT can be very valuable for those getting started. But I also like to remind the listener too, that cone beam is a static process, and when we embolize the prostate, it is quite dynamic and things change in real time, and there’s nothing like just standard fluoroscopy to ascertain what’s going on. So that’s good.

Kind of similar to workflow and operations, are you doing anything specific for your prostate patients in imaging beforehand on any CTs or MRIs?

So I don’t require them to get MRs, but I do get CTAs on the patients for multiple reasons. One, I want to know what the arterial anatomy is looking like before I get started. Tells me the prostate size, look for corona mortis. Just to sort be prepared when I’m getting in there to know what I’m up against. But that’s the only thing that I require. Now, many of my patients are referred from the urologist, so they’ve had a workup, they’ve had PSA, they’ve had— If there’s a question of cancer, they’ve already had an MRI and so forth, so it actually takes some of that burden off of me.

It’s interesting. I was going to raise this question earlier to you. I’ve actually seen a rash of patients sent to me by the urologist on Flomax®, and they come in and they go, “My IPSS score is like three. I’m really happy. I’m great.” And I’m like, “Well, why are you here?” And they’re like, “Well, the urologist sent me here because he doesn’t want me on Flomax long term.” How do you deal with that? What are your thoughts regarding that?

That’s a good question. If you have pretty mild symptoms and you’re doing pretty well on Flomax, it’s kind of hard to argue with it. But I’ll tell you where I maybe get concerned is maybe for some of our more elderly patients, and Flomax in particular, it could be an issue in terms of getting light-headed, potentially falling, certainly. There could be an argument to be made in those cases.

I think for me though, it usually comes down to how much the medicines are helping. And if you still have at least moderate symptoms despite medications, I know the medicines aren’t going to make you any better. And at that point I think it’s reasonable to offer treatment.

Yeah, yeah. That’s a discussion we generally have. And I tell them, “If you’re happy with where you’re at, there’s no reason for us to intervene on you.” And most of them are real happy with that discussion.

Yeah, I think that’s great. So it’s good to hear you’re collaborating with urologists. I think that’s hard for certain folks, very dependent on your local relationships. So really, really good to hear it. And for the GAE that you have done, is that mostly orthopedic driven?

I’ve had my marketing team go and talk to orthopedic surgeons. It’s been more self-referral, but I think this is all the domino effect. You have to get that first orthopedic surgeon to send one, and then that patient is happy, and then the next patient comes, and the next patient comes, and the next patient comes. So I haven’t had that first domino fall effectively yet with ortho.

Yeah, and I think once you have it fall, I think you’ll be overwhelmed. I’ve definitely noticed that myself. And for me it’s been a lot of orthopedic post-knees and then patients who maybe are not ready for a total knee who are no longer responding to steroid injections or other knee injections. That’s kind of been the situation for me.

Well, as we kind of wrap up our podcast here, I wanted to look ahead with you real briefly, and we touched on a lot of advocacy things during this talk. We talked about a lot of the efforts nationally to move our field forward. What do you think we really need to solidify PAE, even though we know it works and it has great data, and to really take GAE from kind of an emerging treatment to something that is as solid as PAE, if not more solid? What do you think needs to happen?

Well, I think it goes to data, data, data. Real estate is location, location, location. In medicine, it’s all about the data. And to that end, OEIS has actually put together a embolization registry so that we can accumulate data to be able to effectively send the message with data to support how effective these treatments are.

And I know Kavi, you’ve been involved in the registry, and we have multiple individuals across multiple different, if you will, subspecialties in IR including interventional oncology. And we have GAE, HAE, PAE, UFE, chemo embo, Y90, I don’t think I’m missing anything else, but literally we’ve got an area for data collection for all of these embolization techniques. And I think it’s very exciting. I’m really very excited about getting the embolization registry up and running and collecting data so that we can produce papers. And again, that registry would be available to individuals to use if you’re in OBL, ASC, or hospital outpatient setting. So we just really want to get the data to be able to support our message.

I think it’s great that you mentioned that, and it’s crucial because unless we have everybody in our community pitch in and actually produce data to prove what we can do for patients, it’s a tough game to play otherwise. It may not get reimbursement. We reduce patient access, and it doesn’t help any of us.

I’ll tell you, at least when it comes to GAE, I’m very optimistic. I’m looking forward to a couple of randomized trials that are currently in play that are currently enrolling. I think it’ll be very exciting to see comparative data in this space. So we definitely need to know where GAE falls on the algorithm for osteoarthritis pain. So comparative data is going to be really important. And I think to that effect, I want to put a plug-in for anybody doing this to do so responsibly. To do so on patients and to contribute to data and try to do so in a way where we can help advance this forward, because we do worry about things like overutilization and causing issues on that front. So that would be kind of my words on that. And certainly advocacy and fighting for what we do is very important, and proud to do that with you and hopefully move things forward for all of us.

We’re all in the same boat, so we all need to be rowing in the same direction. I think you hit it right on. People need to be doing these things responsibly, and if you can contribute your data to a storehouse, like an embolization registry, how compelling is it to say that 50,000 of these have been done and the patient outcomes were extraordinary, patients were happy, IPSS scores dropping, and for geniculars similar changes in the WOMAC and so forth, to be able to put those numbers out there? And I acknowledge, look, it’s not a randomized controlled trial. It’s not something that has the same panache, but when you look at payers and you look at the federal government, they’ve already acknowledged that registry data is very good. They’ll rely on it, because there’s not a lot of other data out there. And to be able to do randomized controlled trials, you don’t get the same kind of volumes that you get with, let’s say, a drug trial where you can give a placebo and so forth. When you’re doing procedures, it’s just not the same. How do you give somebody a sham procedure, right? It’s done. I understand it’s done, but it’s not like you’re doing thousands of these and thousands of sham procedures to get that kind of statistical significance.

Definitely. And there is power. There is a lot of power to real-world practice patterns and evidence, and it’s good that we have registry data for that. For sure.

Well, Jerry, any other words of wisdom for the listeners?

No, I’m all wisdomed out, I guess, at this point.

Well, excellent. Well, it’s been a pleasure. I’ve always enjoyed talking with you and learning from you, and I just want to take this opportunity to thank the Cook@ SIR podcast series for having us on. It’s been fun, and hopefully our listeners gain a lot of insight from this conversation.

Thank you very much. We appreciate— Kavi, I appreciate you, and I know the listeners appreciate you. And again, thank you to Cook very much.

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