Surgeon: Michael Borofsky

Moderator: Dominik Abt


Dr. Michael Borofsky is an assistant professor of urology at the University of Minnesota medical school.  He completed his general surgical and urologic training at New York University Medical Center and later a fellowship in endourology at Indiana University Health Methodist Hospital.  His clinical and research interests are focused upon endoscopic and minimally invasive solutions to treat kidney stones and BPH related voiding dysfunction.

 

Dr. Dominik Abt is Associate Professor and staff member of the Department of Urology, School of Medicine, University of St. Gallen, Switzerland and co-head of the Division of Experimental Urology. He is specialized in Surgical Urology (certified by Swiss Urology) with a focus on endourology and robotic surgery and a Fellow of the European Board of Urology (FEBU).

Treatment of LUTS suggestive for BPO represents Dr. Abt’s research focus of. He is principal investigator and sub-investigator of numerous trials assessing a broad spectrum of LUTS/BPO treatments including prostate embolization, HoLEP, Aquablation, laser vaporization, TURP, and iTIND. Dr. Abt published and co-authored more than 100 scientific articles and was awarded with the Werner-Staehler-prize and the Wolfgang-Mauermayer-prize of the German Society of Urology (DGU) for his research on Prostatic Artery Embolization.

He is a member of the Working Group Benign Prostatic Syndrome and guideline panel member for Benign Prostatic Syndrome of the German Society of Urology (DGU) and reviewer for numerous urological and medical journal.

 

Webinar Transcript

Dr. Amy Krambeck:

Hello, I'm Dr. Amy Krambeck. Welcome to our presentation today. This is a program sponsored by the Endourological Society and Society of Urologic Robotic Surgeons, Masters class in Endourology and Robotics webinars series. The purpose of this series is to provide our attendees an online program, dedicated to surgical techniques in endourology and robotics. The target audience is really physicians that specialize in endourology and robotics. The objective is to identify specific examples of deferring technology and the critical steps in the technique, differences in application and how to avoid and minimize the risks and complications. This is accredited, so you will get CME credit, and we'll go over that in just a minute. I'm really excited about today's presentation. It's October 30th and we're looking at the role of embolization in the management of BPH.

Dr. Amy Krambeck:

Our surgeon is Dr. Michael Borofsky and our moderator is Dr. Dominik Abt. Dr. Borofsky is an assistant professor of nephrology at the University of Minnesota Medical School. He specializes in the surgical and urologic training or treatment of BPH and stone disease. He underwent his training at New York University Medical Center, and later did a fellowship in endourology at Indiana University Methodist Hospital. Dr. Borofsky is a well-known expert in the field of hold up, but he also has some knowledge and interest in embolization. So we'll hear from him today. We also have Dr. Dominick Abt, who is an associate professor in the department of urology, school of medicine at the University of St. Gallen Switzerland. He is also co-head of the division of experimental urology. He specializes in surgical urology with a specific focus on endourology and robotic surgery. Clinically, he focuses on the treatment of LUTS, secondary to BPH, and has also done extensive research.

Dr. Amy Krambeck:

He's been an investigator or a sub investigator on multiple trials for prostate embolization, pull up, Aquablation, laser vaporization, TURP, and iTINT. I'm very excited about today's presentation from these two experts. For CME, you will receive a survey from Michele Paoli. Please indicate which seminar you attended, and you will get the CME certification. Please fill out the evaluation questionnaire at the end of each seminar. And please use the question and answer function to ask questions today. This is a great part of the seminar, and the ability to ask questions of these experts is what makes this special. Without any further ado, we'll have Dr. Borofsky start.

Dr. Michael Borofsky:

Thank you for the warm introduction and thank you everybody for your attention and to the Endourology Society for the opportunity to present. As Dr. Krambeck mentioned, I do have a number of interests in BPH. I'll tell you that majority of my BPH surgery is a nucleation, but I do think there are roles for other alternatives in select cases and prostate arterial embolization is one that I've had some familiarity and experience working with. I'm going to try spend the next 15 or so minutes talking about what this technique is and who it's a good option for. These are my disclosures. So it's 2020. We clearly have a lot of BPH treatments out there, and it's becoming an ever more crowded arena, and it's a little bit more confusing than ever and which patient should go with which treatment.

Dr. Michael Borofsky:

In selecting patients, I think it is very important that we educate our patients as far as what's available to them and where one patient may stand to get symptom improvement. And this is a discussion that takes a little bit of time. I want to give you guys some guidance on PAE. First, before I get too much into it, I do have to say that I'm not an interventional radiologist and I myself do not perform these procedures, but work collaboratively and closely with our interventional radiology department in Minnesota. And I think PAE, when a lot of people hear it, there tends to be a little bit of a tendency to push this off as interventional radiologists, just trying to get into the BPH landscape.

Dr. Michael Borofsky:

But if you really think about it, urologists and interventional radiologists collaborate all of the time and they are friends. We use their services and their expertise when we're obtaining percutaneous biopsies, when we're operating renal masses, sometimes when we're treating pseudoaneurysms or embolizing renal traumas, when we're draining abscesses and placing the frost tummy tubes. Interventional radiologists and urologist should be friends. And in Minneapolis, my good friend is Dr. Jafar Golzarian and I got a lot of these slides and some of the technical insight from him. He is the interventional radiologist who performs the PAEs at our institution. At first, I was a little bit hesitant to start much of a collaboration, but I will tell you that since we've started working together, it is quite common for patients to reach out to him directly and ask to go straight to PAE.

Dr. Michael Borofsky:

He'll send them to me for an evaluation. We'll maybe take the patient off to a different direction that may be more suitable for them. But similarly, I will send him patients that come to me for BPH treatment that I think PAE is a good option for. A collaborative effort here is absolutely paramount if you're going to be offering PAE at your institution. In general, what PAE is, is targeted ischemia to the prostate that's achieved via installation of microembolic agents. And this is usually cheap via peripheral arterial access. Initially, this was done through femoral groin punctures, but more recently there's been increased ability to offer this through a radial arterial stick. And it is very cool when a patient comes in for a PAE and leaves with literally just a bandage on their wrist. I think that CFPAE is most commonly believed to occur via tissue ischemia and infarction of the prostate, but certainly some other potential therapeutic pathways have been suggested, included local androgen deprivation, denervation and urethral decompression, which we don't have as much data for.

Dr. Michael Borofsky:

Preoperatively, all of our patients who we're going to be considering for PAE, will consult with the urologist to confirm that their outlet obstruction is truly BPH related as you can't take the fact that you're going to be doing any sort of endoscopy at the time of the procedure for granted. You want to make sure, preoperatively, that they don't have a stricture or other bladder pathology that would make them a suboptimal candidate. We'll often commonly do imaging in the form of a TRUS-CT or MRI and one thing in particular that's unique for PAE is that patients or our interventional radiologists typically want a CT angiogram to map out the vascular anatomy. And that has a role in patient selection and technical success because the pelvic vascular anatomy can be quite variable. And in some of these elderly men with larger prostates, it can be quite challenging. There can be a lot of atherosclerosis and torturous vessels that may make the technical success of the procedure a bit more challenging. So it's important to know this preoperatively, as some patients might not be good candidates just off the bat. We know from prior anatomic studies that prostate arterial anatomy can be quite variable, it almost always comes off the internal iliac artery, but the sub-branch and the division that actually feeds the prostate can be extremely variable with different origins that differ from case to case.

Dr. Michael Borofsky:

This is what a CT angiogram with 3D reconstruction looks like. And you can see all of these vessels in this massive prostate that are going into the pelvis. And this is information that's going to be more meaningful to our interventional radiologist prior to the procedure. At the time of the procedure itself, most of these are performed under local anesthesia, so potentially applicable to some of our higher risk patients. Arterial access is achieved, and then an angiogram is performed. Le me go back. Okay. The angiogram typically microcatheters are usually used to guide a selective catheter into the prostatic arterial supply. And then an angiogram will confirm that you're in the correct artery. Oftentimes because there are so many vascular anastomosis in our kids in this region, a cone beam CT can be used intraoperatively to really make sure that your catheter is in the correct artery, and also to make sure that you're not inadvertently blocking off the blood supply to an adjacent structure like the penis, the bladder, and the rectum, which would obviously be troubled. This is started on one side with a unilateral embolization, and then once this is achieved, the interventional radiologists will go to the contralateral side. And then patients typically are able to go home either typically at the same day with or without a catheter, depending on their circumstance.

Dr. Michael Borofsky:

There have been a number of papers published over the last several years on PAE, and the general trend that's come out in the literature is that this likely has more efficacy in patients with larger prostates. This is a study from China, published about four years ago from BJU. And what you can see here is in a case series of men with larger, greater than 80 gram prostates versus kind of a more medium 50 to 80 gram range, how comes were better? They were good in both groups, but the men with larger prostates had a greater improvement in their IPSS reduction, a greater improvement in their quality of life scores, substantial improvement in their prostate volumes with over 50% reduction in prostate sides, better improvements in Qmax and a lower post-void residual. And this has bared out in several other studies as well.

Dr. Michael Borofsky:

More recently, there was RCT that compared PAE to a sham control with cannulation of the arterial supply and installation of [inaudible 00:10:42]. This RCT was performed in Portugal, and you'll see here in this figure that in the single blind period, the patients who were treated with sham did not see the improvement in their IPSS scores as the patients who were treated with PAE. And notably, in the open extension period after six months where the sham control patients were offered the ability to undergo the actual PAE, you saw an improvement in that cohort as well, really proving the efficacy of the procedure. One thing I'll point out that differs in this study relative to some of the other minimally invasive new studies that have been published for various technologies and prostates is that the average prostate volume, in this group was about 81 grams. These were men with very large prostates relative to some of the prior trials related to prostate like urethral lift and thermotherapy of the prostate,

Dr. Michael Borofsky:

One of the other considerable studies that it's been out and published in the last couple of years, is the UK ROPE Study, which was a registry study that had 17 participating centers from the UK. They found 216 patients undergoing PAE and compared them to 89 undergoing TURP and looked at IPSS improvements and adverse outcomes at 12 months. In the propensity matched patients at 12 months, there was a greater improvement in IPSS reduction in the patients undergoing TURP than those undergoing PAE, and there was an improvement in quality of life as well, though it was a positive and it was beneficial in both groups. And when you look at the adverse event rate for PAE, which is something that we use commonly when we're counseling our patients, you can see that retrograde ejaculation occurred as the most common adverse event. This occurred in about a quarter of patients. Hematuria and hematospermia were also relatively common, but the other side effects were a rare. I will point out that reoperation, 5% of the patients undergoing PAE ended up with another procedure in the first year. And there's been estimates of another 15% of patients who underwent reoperation after 12 months. So this is something I'll come back to, that the potential for reoperation after PAE is a bit higher.

Dr. Michael Borofsky:

We're fortunate in Minneapolis that we work with, Dr. Phillip [Dom 00:13:03] and the Cochrane Review for urology, which is based out of our local VA. And we currently have a Cochrane Review looking at PAE versus TURP, that is hopefully going to be published soon, but to give you a sneak peek at what the data shows, among six RCTs that have compared PAE to TURP, within 12 months, it does not look like there is a major difference as far as IPSS score improvement. Though this was a low certainty of evidence, but similar improvements in both the PAE and the TURP populations.

Dr. Michael Borofsky:

Interestingly as well, we did not see a substantial difference in major adverse events between the patients and the RCTs. So again, low certainty of evidence, only four studies. What we were slightly more confident about, is that the reoperation rate likely favors TURP with a lesser likelihood for needing a repeat treatment in the first 12 months. So again, low certainty of evidence, only three RCTs. And this was short term at only 12 months. What do the guidelines say? If you look at the AUA guidelines, they suggest that PAE for the treatment of LUTS, secondary to BPH, is not supported by current data and trial designs. And the benefit over risk remains unclear. Therefore, it is not recommended outside the context of a clinical trial. And it will say that this is somewhat of a controversial opinion particularly among the interventional radiologists that I know. I do believe that as more data comes out, it will be interesting to see whether or not any changes occur in the coming years from the AUA. The EAU differ somewhat. In the most recent updated version of the BPH guidelines, PAE has found a role with statements saying that, PAE is less effective than TURP at improving symptoms and urodynamic parameters. Procedural time is slightly longer, but blood loss, catheterization and hospital times are in favor for PAE.

Dr. Michael Borofsky:

And they do recommend that PAE can be considered for men with moderate to severe LUTS who wish to consider minimally invasive treatment options and accept a less optimal objective outcome compared with TURP. They also make note of the fact that they do recommend that patients undergo PAE among systems where urologists and interventional radiologists collaborate. So there are some existing limitations, including where really is the role for PAE among the currently available BPH treatments. This still needs to be better defined. We need more studies. We need urology collaborations with our IRL colleagues, and we really need comparisons to some of the other newer, minimally invasive surgical treatments for BPH. Another thing that is poorly defined is the radiation risk. With a CT angiogram, with intraoperative fluoroscopy and angiography and CT, there are some unique radiation risks to this procedure that might affect potentially men differently than those undergoing more traditional BPH surgery.

Dr. Michael Borofsky:

What I do in my practice, I find that PAE has been a nice option for some of my very elderly patients. Some of them ones with very high comorbidities who are at high risk of bleeding or anesthesia related complications. I've also found a role in patients who have large prostates and have BPH but very minimal urinary symptoms. And they're just having recurrent, hematuria from BPH alone. I do think there may also be a role for some of the suboptimal candidates for traditional MIST therapy, where ejaculatory preservation is very important. It's unlikely, let me amend that statement. I think that some of the patients with very large prostates, there's not really a MIST that is most appropriate for them. And they think that the role for PAE might be most suitable here in these men with the bigger prostates who still want to undergo a minimally invasive therapy.

Dr. Michael Borofsky:

And this has led to some of the considerations for future directions of the field. I've gotten to know some of the society of interventional radiology. People who are very involved in PAE and I've learned a lot from them. We had a research meeting, a couple of years ago in Washington DC, and basically consensus was reached that there should be an RCT for PAE versus a treatment that's used exclusively or specifically for large prostates. And this would be because some of these men with very large glands have fewer treatment options. They're going to be more likely to require an enucleation or a simple prostatectomy and PAE outcomes are also likely better in this group. I do think there is a role and a need for a study such as this in the future. And just some practical tips before I finish, I do recommend that if you are going to venture out and start offering PAE to your patients, this is not the type of procedure just to put a referral in your electronic medical system and then walk away from the patient. You should really understand what is going on.

Dr. Michael Borofsky:

What, after you send the patient for consultation, you need to talk to the interventional radiology team. You have to make sure they're familiar with the procedure that they're comfortable offering it, and they should be a collaborator with you in following up that patient's care so that you understand that you're achieving the goal together. I also think it's very important to define patient expectations. There is a likelihood for a higher retreatment, and this is a risk that some patients are more willing to take them others. So I'd like to thank you for your time. I look forward to any of your questions and I'll hang around for the end, but at this point I will hand over the microphone or the zoom, so to speak, to Dr. Abt. Thank you.

Dr. Amy Krambeck:

Great talk, Dr. Borofsky. And while we're transitioning over to Dr. Abt, I wanted to ask you, you briefly mentioned it, but what are the average radiation times for these procedures? I know when it first started, the times were really high because they were just developing the procedure. But what is to be expected now during a case, what would be normal?

Dr. Michael Borofsky:

Yeah. Again, I do have to point out a disclaimer that I'm not actually the one performing these procedures. I apologize if there are any interventional radiologists out there and I misspeak, but they are quite long. Average fluoro time can be on the order of 20, 30 minutes or so. And from what I understand and talking to my interventional colleagues, this is a technically very complex procedure to learn. There's an art to kind of twisting these microcatheters down into these torturous vessels. But the radiation risk is something that I think needs further clarification.

Dr. Amy Krambeck:

Okay. That's perfect. We'll have several more questions at the end. I can't believe they can do this actually. When you look at what they're able to do endovascularly, it's very impressive. All right, Dr. Abt.

Dr. Dominik Abt:

Yeah. Thank you very much. Hello everybody. Thank you for your nice introduction, Amy, and thanks for this excellent talk, Michael. There's not much left to save from me after this talk. I'm really delighted for the invitation to participate in this exciting session and my task is to discuss some cases, sorts of discussions. Please interrupt me at any time if there are any questions or comments. These are my conflicts of interest. Actually, I'm a urologist like Amy said, with a focus on BPH surgery and robotics. I actually do almost all BPH surgical procedures except from PAE. Nevertheless, it became and fixed part of our armamentarium at our hospital. I think the reason why this became a success story at our hospital, is that we have a very close collaboration with our radiologist and a special, thanks goes to Dr. [Hecht 00:21:19] [lamar 00:21:19] who almost became something like a urological staff member, at least it feels like. And I think there are a few important points why this collaboration works so perfectly. First of all, urology leads patients selection and counseling. Second, we do not have political or financial conflict of interest.

Dr. Dominik Abt:

It's all for one hospital. An important part is we have a special consultation hour for LUTS/BPO. Meanwhile, there's a plethora of treatment options and it's getting more and more difficult to select the most appropriate option for your individual patient. And I think these are the reasons why it became really an established part of our armamentarium during the last seven years. Out of our experience and out of my consultation hours, I want to present some cases to you, and discuss whether these patients are appropriate candidates or if they are rather treated better with another option.

Dr. Dominik Abt:

Let's start with case one. This is really a typical patient that I see in my consultation hours. 59 years old, has a long history of LUTS/BPO. He's a business person, runs his own business. He is refractory to pharmacotherapy. TURP was already suggested, but he refuses it because he's afraid of complications and he cannot afford working capacity. He clearly prefers minimally invasive treatment and can accept an inferior improvement of functional parameters. If you check the clinical findings, his IPSS is 20, has a poor quality of life, reduced urinary stream, and a small amount of post-void residual. We performed an MRI to check or to rule out prostate cancers. Prostate volume was 60 CC and cystoscopy suggest prosthetic obstruction, otherwise normal. What can this patient expect from PAE? And Michael already gave us a brilliant overview. I'll make it really short. He can improve a reduction of symptoms that is, let's say, quite close to that achieved by TURP. But on the other hand, improvement of functional parameters like Qmax or post-void residual would be clearly better after TURP.

Dr. Dominik Abt:

At our institution, the average decrease in IPSS is around 10 points and the average improvement of Qmax is between five and six milliliters per second. These are realistic numbers, I think. Moreover, you can expect key advantages regarding safety. We did this MIST analysis very recently. And we found that complications occur in about 50% of the cases that they occur after TURP. In addition, we found less severe adverse events. This is somehow contradictory with what Michael said about the Cochrane Review, but this is what we found in this review. Well, yes, I would say this is a very appropriate candidate for PAE because his expectations matched very well with the profile of PAE. But my recommendation would completely change if we only would slightly change the clinical findings. This is the same IPSS, same Qmax, same post-void residual, but now in MRI, the prostate volume would be 26 milliliters and in cystoscopy has relatively narrow bladder neck.

Dr. Dominik Abt:

Now my recommendations would really be completely different because, as Michael already shown, prostate anatomy really matters. Small prostate have a higher risk of clinical failure. And our own patient cohort, we try to define the optimum threshold to predict a clinical failure or clinical success. And as you can see here, the bigger the better. This means, patients with a small prostate can still have a very brilliant outcome, but they are at an increased risk of having a clinical failure. In addition, this patient has a relatively narrow bladder neck, and I think this is something important, especially for small prostates. There is no evidence around for that so far, but in our experience, these are very unfavorable candidates because PAE won't open splatter neck. It's a soft copy before you perform PAE in any case I would recommend. If there are any questions or comments, please let me know. Otherwise, I would change to case two, which is completely different. This is an octogenarian with relevant comorbidities. He has a history of LUTS/BPO, so far only plant extracts. But now he's hospitalized with accurate renal failure and overflow incontinence. And ultrasound examination reveals that he has bilateral hydronephrosis, has a prostate volume about 78 milliliters, which would be okay for PAE or good for PAE, but he has a bladder volume of 1.7 liters. And in addition, a reduced renal function.

Dr. Dominik Abt:

I think I can cut this and make the story short. The conclusion would be, this patient is not really suitable for PAE, because he requires maximum of relief of that outlet obstruction to have a realistic chance of spontaneous voiding in the future. And as we could show in our randomized control trial, relief of bladder outlet obstruction is not optimal after PAE or 12 weeks after treatment, only one third of the patients are keyed in non-obstructive according to pressure flow studies, when another third is equally vocal or obstructive respectively. In addition, this patient has an impaired renal function. He's not suitable for application of contrast medium, and he has some comorbidities that are really associated with very challenging vascular conditions during PAE. There are data that suggest that such patients are still feasible and PAE works in a majority of these patients, but I would recommend, in any case of such patient, that we perform an MRI to estimate the vascular situation before performing PAE.

Dr. Dominik Abt:

This is case two. We see such cases very often at our department. Case three is something we also see because we have a center of tertiary care and there are many patients with cardio problems and could be a typical patient, 75 years old and underwent coronary standing three weeks ago. During hospitalization, he suffered from acute urinary retention and two tries without catheter failed, despite already being on maximum pharmacotherapy. Why his cardiologist tells me that he has dual platelet inhibition including probably grill for 12 months, the patient tells me that he cannot accept an indwelling catheter under any circumstance. These are the clinical findings. We performed another trial without catheter. He has urinary urge at 500 milliliters of bladder volume, but voiding again is not possible. His prostate volume is 92 milliliters according to TRUS and well, who wants to operate this patient?

Dr. Dominik Abt:

Well, honestly, nobody. And this is of course the right decision, because we know the change from clopidogrel plus aspirin to aspirin only too early, represents a massive risk for this patient. And if we now say, "Okay, we perform, maybe for example, a GreenLight and continue probably to grill, you have to know that any surgery and the anesthesia increases risk of major adverse cardiac events in this patient, even if clopidogrel has continued. At least for the six to 12 months after standing, this is really irrelevant risk. And of course, this is where PAE comes into play because you routinely perform it under local anesthesia and you can continue any kind of anticoagulant drugs

Dr. Dominik Abt:

I showed that the relief of obstruction is inferior compared to TURP. So the question arises, is it enough to get rid of the catheter for this patient? And there are two rather small studies assessing this specific question. It's important that both include patients with rather large prostates, but both have really promising success rates. And this matches quite well with what I see in clinical practice. In this case, I would clearly recommend that PAE represents a very valuable option. If there are any questions or comments, let me know. Otherwise, I would move forward to this case, which is completely different. It's not about patient selection, but it's about postoperative care.

Dr. Amy Krambeck:

Dr. Abt, can I interrupt with one question? On previous case, the patient has cardiac risk and so on. The patient with cardiac risks, you they're going to have significant atherosclerosis as well. Do you base this on the CT angiogram, and if there's not a lot of atherosclerotic lesions in the pelvis, then you go ahead with the PAE?

Dr. Dominik Abt:

Exactly. At our institution, we perform an MRI with contrast beam instead of a CT angiogram to reduce a radiation exposure. But with an experienced interventional radiologist checking this MRI, you can predict quite good if it will work or not.

Dr. Amy Krambeck:

All right, thank you.

Dr. Dominik Abt:

Okay. So this is case four. This patient already underwent PAE because he was in retention and had an indwelling catheter and he had a 102CC prostate. The postoperative course was kind of difficult. At the day of PAE, had severe pain with the VAS score reaching up to seven in the lower pelvis. We were able to remove the catheter successfully, but during the first two weeks, he had burning sensations while voiding. And now three weeks after PAE, he shows up at the ER and has urinary tract infection and some kind of strange intermittent urinary retention. So this is a case out of our real practice. And the picture is of course not a real patient, but the MRI is, and I was quite confused when I saw this for the first time. So I didn't know what was going on. And so we've performed a cystoscopy. Now, I don't have the control over the ... Okay, perfect. What we found in sister's copy that is, this patient had a complete repulsion of the central gland of the prostate into the bladder. And we had to remove this through a resectoscope. As you can imagine easily by checking this MRI image postoperatively, he had an excellent clinical outcome afterwards.

Dr. Dominik Abt:

Can we move forward? Okay. So what can we learn from this case? Well, first of all, postoperative pain can occur after PAE, actually quite frequently. But it's almost always limited to the first eight to 12 hours and you can control it easily with analgesics. And you can calm down your patient because it is associated with a really favorable clinical outcome, which is statistically, significant at least in our department. The second thing is that, tissue repulsion after PAE can occur. It is quite rare. It was around 6% in our RCT, but you should keep in mind, especially in cases with urinary tract infection and intermittent retention, it can require an intervention, which is of course, what patients undergoing PAE wanted to avoid, but it is associated with really a favorable clinical outcome. The conclusion would be that postoperative care of PAE patient not really different to other procedures, but some special characteristics have to be kept in mind. My summary would be that PAE has been shown to be safe and effective at least in the midterm.

Dr. Dominik Abt:

It is inferior regarding efficacy compared to receptive techniques and therefore higher retreatment rates are likely. But it also has some unique selling propositions, including a continuation of anticoagulant drugs, no upper prostate size limits. You can perform it on a local anesthesia and you do not require physical rest afterwards. The take home message would be, you should know the profile of PAE and you should know the clinical findings and expectations of your patient, then check thoroughly if they match, and if they do, then of course PAE can represent a valuable option in our treatment armamentarium. Thank you very much for your attention and I hand over to Amy.

Dr. Amy Krambeck:

Well, thank you both. I think those were exceptionally informative talks and I especially like going through different cases so that we can get an idea of who's appropriate for this technology. I think I'm just going to go through some of the questions that came in during the different talks and just direct them to each one of you. So Dr. Abt, you did discuss pain, and you said it can occur in the first 12 hours, but beyond the first day they should not have pain. Is that correct?

Dr. Dominik Abt:

I never saw this. There might be kind of burning side sensations while voiding, but real pain in the lower pelvis. We only see this during the first eight to 12 hours in this embolization syndrome or a reaction of the prostate.

Dr. Amy Krambeck:

What about fever or malaise or anything like that? Does that occur?

Dr. Dominik Abt:

Well, according to the data that is a way level, it occurs in up to, I would say, 20 to 30%. We don't see that often at our institution. I don't know why, but it can occur, but it's not a sign of infection, but just a tissue reaction. You often see this after kidney embolization, but it's quite a rare phenomenon after PAE in our department.

Dr. Amy Krambeck:

Michael, is that the experience as well?

Dr. Michael Borofsky:

I will say that pain, I don't want to say it's a common thing, but we have had several patients who've had really bad, just pelvic pain, bladder spasm self-limited for a couple of days. No data here to support this, but I do also find that these tend to be patients with really large prostates. Interestingly enough, you get to know these patients a little bit, because sometimes they end up in an emergency room or they're they call the office a lot with discomfort. But long-term, I have anecdotally noticed that they might be the ones who respond well versus the ones who have no symptoms afterwards. You wonder whether or not there's any ischemia or infarction. I do counsel, but some of the patients that I send with really big prostates, that might be a possibility.

Dr. Amy Krambeck:

Okay. But Dr. Borofsky, in your talk you talked a little bit about retrograde ejaculation. And I was somewhat surprised by that because in my mind that occurs when you resect the bladder neck. What do you think is contributing to that in these particular cases?

Dr. Michael Borofsky:

I don't know if anyone really knows, I do know that there have been published reports of seminal vesicle necrosis after PAE. And I do wonder whether or not it's not so much a retrograde ejaculation, but an anejaculation altogether. You're causing a lot of ischemia to the prostate and its potential neighboring structures. You could get some fibrosis of the ejaculatory ducts or something like that. But I do think it's important because, I think a lot of people think of PAE as in the same category as thermotherapy or prosthetic urethral lift, and maybe send them because there's a no risk or low risk of anejaculation or sexual dysfunction, but it's, in that UK ROPE Study, it's not quite as low as some of the other alternative options.

Dr. Amy Krambeck:

Yes, Dr. Abt.

Dr. Dominik Abt:

I think that's an important fact because at our institution, we found quite similar numbers like the UK ROPE Study. And previously it was always thought that there is no chance of developing ejaculatory disorders. But it can occur. In most of the cases, it's just a reduction of the ejaculatory volume and not complete anejaculation. But we used to assess 12 patients that underwent prosthetic artery embolization six weeks prior to radical prostatectomy, of course within a clinical trial. And then you could see by histological examination that, all the glandular structures were completely shrinking and the seminar ducts were completely atrophic. I think that it's very well explainable and that this happens.

Dr. Amy Krambeck:

Very interesting. Okay. You guys already touched on some ischemia. One of the questions that came through is how likely is it that you will develop bladder ischemia? How common is that complication?

Dr. Dominik Abt:

Oh, well, Michael, if it is okay, I'll answer this question. We saw so far a single case in several hundred cases. In this case, you only became aware of that because he underwent postoperative MRI within a clinical trial. Otherwise he had no symptoms at all. I think nowadays with an experienced radiologist, this should not happen with a relevant extent, so that no action would be needed if there is a really a small part, which is ischemic in the bladder. We never had really a problem with this so far.

Dr. Michael Borofsky:

Yeah. And I would also say, I've never seen bladder ischemia, but theoretically, those non target embolizations could occur in the bladder, the rectum or the penis. And my understanding is that, if they do occur, they're typically transient and self-limited and then you get some focal ischemia. I don't think it would be likely that you get massive bladder necrosis or total rectal necrosis or penile necrosis. I have seen some penile edema and some ulceration that occurred for a short self-limited period of time that resolved within a couple of weeks. But it's a concern. It was a 2% risk of non-targeted embolization in that UK ROPE Study.

Dr. Amy Krambeck:

Yeah. And I think these are points that the viewer should realize. That this isn't like pelvic embolization for trauma, where they're just throwing these cell emboli all over the place to get the bleeding stop. It's very targeted, very precise. These ischemic complications really just shouldn't occur. Correct?

Dr. Michael Borofsky:

I would point out, we're fortunate, I would say, to have to do this with people who specialize in this and like any technique, this is something that I would say you really want to work with someone who's experienced and technically able to perform the procedure. I would very much recommend that you talk to your interventional radiologist before doing this, because my understanding is that, there can be a huge difference in the quality of the procedure based on your experience, like anything, but that could play into this as well.

Dr. Amy Krambeck:

Okay. Another question was, how do you handle the arterial perforation? What is done? Do they use a closure device, or how is that treated? Afterwards did patients have to limit activity? What is done there?

Dr. Dominik Abt:

You mean the puncture side?

Dr. Amy Krambeck:

Yes.

Dr. Dominik Abt:

Yeah. IRs nowadays have really interesting tools, how to close it with some kind of clue. What patients need is something like compression for one to two hours and afterwards they allowed to do whatever they want to do. this is not really a problem anymore.

Dr. Amy Krambeck:

Well, that's great. I think Dr. Borofsky was saying, they're using brachial artery or a radial artery. What is the distribution? Is it about 50% are done femoral 50% radio or not that much? Because I think a lot of people worry about the femoral artery being used as just at an uncomfortable location.

Dr. Michael Borofsky:

Yeah. It's a really good question. Quite honestly, I don't know the answer. I would imagine this has some ... I don't know how to answer that. I wonder if it's like a prone versus supine PCNL kind of thing where you just kind of have a technique that you get good at and prefer.

Dr. Amy Krambeck:

I think you're probably right. Has anybody looked at any histopathology after embolization? I know we don't normally get the tissue. But I don't know if anybody has any experience or know the literature about what the histopathology of the prostate looks like afterwards.

Dr. Dominik Abt:

Well, we have a lot of experience with histopathology. On the one hand, out of this study where we performed a radical prostatectomies after PAE, which of course allowed an estimation of the full amount of prosthetic tissue. And what you can see there is that necrosis and fibrosis occur in the central gland while the peripheral gland is almost untouched. It really works in the central gland in the peripheral. It's harder to estimate tissue that is obtained by TURP because normally you treat patients that failed after PAE and most of the time they don't have an appropriate embolization. If you resect this patients, and it's not a problem at all, there is less bleeding, but you see the small emboli. And if you open one, there might be just some bleeding, but you can easily correlate it and you can perform any kind of surgery after embolization. It's not a problem. If PAE worked really well, then you normally don't perform a TURP, so you won't have tissue to assess.

Dr. Amy Krambeck:

Michael, have you done enucleations after embolizations and have you noticed any difference there?

Dr. Michael Borofsky:

Yeah. I've done a handful. There was one or two patients that we actually had tremendously high risk of bleeding. We embolized kind of the day before because there came in bleeding here and when our initial instinct is often to do an enucleation, I do think there may be a role in these extremely elderly frail sick patients to use this for sudden hematuria. The procedures themselves have been no different. I would argue if anything that your dryer, the prostate tends not to bleed as much. And I have come across a couple of times, a couple of little embolic agents, but they've been in consequential to the plains or to the procedure.

Dr. Amy Krambeck:

Wonderful. Well, that's a great use of PAE as well. I think especially in the massive prostates. And there was a question that just came in was, is there an upper size limit? I know that you both talked about how it's probably not ideal for the smaller prostates and you don't really offer that for smaller prostates, but are there prostates that are too big, that you say, "Well, this is not going to help either."

Dr. Dominik Abt:

Not to my knowledge and not to my clinical experience. I fully agree with the statement that the bigger the prostate, the better your outcome will be.

Dr. Michael Borofsky:

The biggest one we've embolized was a 400 gram prostate. A patient symptomatically did very well, got off medication and improved his IPSS scores by half. He still has a 250 gram prostate. You wonder whether or not it's going to be a long-term solution. But interestingly on postoperative imaging, you can actually see that central zone has a different Hounsfield Units and you can kind of see the necrosis or at least the tissue kind of resorbing on the CT. One thing I didn't really mention that I also just think is worth bringing up is, one of the considerations I have here is, incontinence in the very elderly patients with these very, very massive problems is something that I often worry about with enucleation type or big resections. That's another role. I'll sometimes use this and there's an understanding with all of these patients before they proceed that this may not be the permanent solution, but maybe it is an option and maybe it works.

Dr. Amy Krambeck:

In the middle ground. Yeah. Since you're shying away from the smaller prostates, I'm guessing you don't see a large amount of bladder neck contractures after PAE, Has it even been reported as a problem?

Dr. Michael Borofsky:

No.

Dr. Dominik Abt:

Not to my knowledge. And in our department, we did not have one yet.

Dr. Amy Krambeck:

Okay. And then one person asked, can recanalization of the prosthetic artery be a reason for failure? If you think that's happening, would you ever perform a second PAE for a failed primary PAE?

Dr. Dominik Abt:

Of course, this can occur and it also can occur if you don't take enough time during the embolization procedure. So you have to close the vessels and then you have to wait because some times more vessels open that didn't get that much blood before. But if the bigger vessels are obstructed, then the smaller vessels get blurred. This can happen during embolization, but also afterwards. And of course, there are many peoples out there that perform re-PAE especially institutions that only offer PAE. If you consulted a urologist, he might rather say, "Okay, we have tried this, it didn't work. Let's move to another procedure."

Dr. Amy Krambeck:

Okay. I think it's interesting that you said that. Because when we do a enucleation, if we control one bleeder and it's a large bleeder, you'll see two or three open up in a different [crosstalk 00:49:22].

Dr. Dominik Abt:

Exactly.

Dr. Amy Krambeck:

And I call it the whack-a-mole effect. That's its head up there. It's interesting. Is a large median lobe a contraindication to PAE?

Dr. Michael Borofsky:

The data out there would suggest that, like every median lobe out there, patients with a median lobe almost always do better. And I think that's true of almost anything you offer them, but it has not been reported. And in fact, from what I'm aware of, patients tend to do better. Just agree or disagree with me on that one.

Dr. Dominik Abt:

Yeah. Actually there's really a study assessing this and they conclude that a large median lobe or intraprostatic protrusion is not a contraindication. PAE works in this case also quite well. But in my experience, the best results that you can achieve when you have a large median lobe is when you remove the median lobe.

Dr. Michael Borofsky:

I would agree with that.

Dr. Amy Krambeck:

Perfect. What do you expect? Mike, you had said you had that 400 gram prostate [inaudible 00:50:34], it was still 200. What is the amount of size decrease or percentage decrease you should expect after PAE? And then what should you expect the PSA to do as well?

Dr. Michael Borofsky:

In this patient's case, the PSA actually went from 40 to five. That was a really unique case that I wouldn't say that's normal. I think the data would suggest that if you're greater than 80 grams you reduction in prostate volumes should be about 50%. And I would, I don't know what the PSA reduction is off the top of my head, but I would expect it to parallel that and maybe a reduction of about 50% would be my guess.

Dr. Dominik Abt:

Yeah. That's also my experience. If you check the literature, the average size reduction is between 25 and 35%. A reduction of 50%, again, this massive cross edits is really a good result and the PSA drop in our study was not as pronounced as after TURP. So if you do a proper resection onto the capsule, then your PSA decrease is likely to be a more pronounced enough prostatic artery embolization. But it is important to have something like a new baseline PSA. Like six or 12 weeks after the procedure, to do you have a better impression of PSA controls afterwards, to see the dynamic.

Dr. Amy Krambeck:

Another question is, do you normally place a urinary catheter for the procedure in men who are not in retention? And then if you do, how long do you leave it in afterwards? Dr. Abt, we'll have in you answer first.

Dr. Dominik Abt:

Well, this depends very much on what your radiologist prefers. They like catheters especially in smaller prostates because they facilitate orientation. They block it with contrast medium and so they are orientated better in the [inaudible 00:52:42]. So our radiologist like it for very small prostates, they do not insist on catheters in larger glands. And if you put in a catheter, you can take it out after PAE immediately.

Dr. Amy Krambeck:

Okay. Is that your experience as well, Michael?

Dr. Michael Borofsky:

Yeah. I would say, it would be very rare for me. Urinary retention is typically a contraindication in my hands for a PAE and usually just doing it with some symptomatic men who are voiding and I would typically, not necessarily expect them to need a catheter afterwards, I suppose, if it was someone who was in retention preply, you would want to leave it in for at least probably two to four weeks. I would imagine after the procedure before you give them a high likelihood of getting out of retention.

Dr. Amy Krambeck:

Okay. So you don't get a swelling of tissue effect that could cause acute retention after this procedure then?

Dr. Michael Borofsky:

My experience has been that, the only time I've ever felt like we really needed a catheter was with some of the patients who've had very bad pelvic pain, thinking that maybe bladder spasms will reduce. It really hasn't helped at all. Really not typically, I have not found that we need catheters and the vast majority of the patients that I have personally seen. But again, non-retention patients.

Dr. Amy Krambeck:

Okay, perfect. Another question that came in is, do you know the size of the symbols that are used and have you ever seen complications such as pulmonary embolus or something related to an embolic complication related to the procedure?

Dr. Dominik Abt:

I think the standard size that is now being used is between 250 and 400 microns. And this is very important because the smaller the particles get the higher, the risk of target embolization. Because the smaller they are, they can distribute where they want to because they are very light. But systemic complications will not occur because they are not able to pass the capillaries. No risk of pulmonary embolism or something like that. The smaller the particles are, the more aggressive they are because they obstruct determined arteries which have no collaterals. But you should be aware not to use too small particles because this is becoming more and more dangerous.

Dr. Amy Krambeck:

Another question is, do either of you have experience with radical prostatectomy after PAE or have sent patients for radical prostatectomy or know how that would go?

Dr. Dominik Abt:

Yeah. Like I said, we did this within the study in 12 patients and our question was, what happens with prostate cancer if you perform PAE. Well, sadly, it didn't work that brilliantly because most of the time prostate cancer is in the peripheral gland and PAE does not work that well in this area. But performing radical prostatectomy in these patients did not differ from any other cases. It had no embolization. It was safe and it felt really normal. I didn't recognize any differences.

Dr. Michael Borofsky:

I can't speak to it. I have not encountered any patients to date.

Dr. Amy Krambeck:

Okay. Well I think we have time for maybe one more question. Have either of you utilized unilateral PAE for patients that had difficult vascular anatomy, so they only embolized one side and not both, has that been effective?

Dr. Michael Borofsky:

I've never intentionally sent anyone for a unilateral PAE, but I do know, I think that can occur. I don't know. That's estimate in somewhere between maybe 10% of the time or so. Technically, you should still get some improvement, but you wouldn't necessarily expect the same degree of improvement as a bilateral PAE. It would never be the intended outcome to only embolize one side.

Dr. Dominik Abt:

In ours, statistically, they have really unfavorable outcomes. And as a matter of fact, 58% of the patients that require reinterventions after PAE at our institution had unilateral PAE because of a challenge vascular condition. Whenever possible, do it on both sides.

Dr. Amy Krambeck:

Wonderful. Well, thank you both. It was a great discussion, great talks and I personally learned a lot. I'm sure the audience did as well. Please join us on November 6th when we will be discussing robotic simple prostatectomy. The surgeons will be David Lee and Burka Turna, with moderators, Jeffrey Gahan, Daniel Sagalovich and Vito Pansadoro. And we encourage everyone who is not already a member, to join the Endourology Society. Your membership dues provide you with multiple benefits, including the Journal of Endourology, Videourology and journals of Endourology Case Reports. So please go to www.endourology.org for more information. And that is it. Thank you all for joining us. And hopefully we will see you at the WCET in 2021, September 21st through the 25th in Hamburg, Germany. Thank you.