Diana Lopategui: Good afternoon, and thank you so much for having me, I'm so glad to be back. Talking about this topic, which I don't perform directly, but as you've mentioned, seen a lot of the patients undergo and discuss this option and refer them often to our colleagues in interventional radiology. We'll base our discussion in a recent publication on the long-term outcomes from a nationwide prospective cohort published last August in European Urology Focus. We'll talk about prostate embolization, PAE. This is a minimally invasive procedure done by our colleagues in interventional radiology. Usually for BPH, there's some other indications such as hematuria. The procedure induces prostatic ischemia, making the prostate reduce its volume. They're reducing the symptoms. This study looked at evaluating short-, mid-, and long-term outcomes in a Danish cohort of patients undergoing this procedure since 2017, the year where the procedure was introduced in the country. This was a multicenter prospective cohort of all the patients undergoing PAE in the country from 2017 to 2022 included.
This procedure is done as outpatient under local anesthesia and guided with fluoroscopy, most commonly nowadays done through the radial artery, sometimes through the femoral. This study looked at the 90-day adverse event rate that were reported perioperatively and examined prostate volume on transrectal ultrasound with uroflow symptom score, as well as when the catheters were removed when applicable. The symptoms score that were used is called Danish Prostate Symptom Score. It is somewhat similar to our AUA symptom score as in it has, in this case, 12 questions that classify patients from mild, moderate, or severe symptoms. This one does include three questions regarding sexual health symptoms. These were their findings in terms of patients included. 336 were followed. This is their age, their comorbidities are documented as well as just remarking that 13% of them had prostate cancer at the time, and 26% on pretty high rate were dependent on an indwelling or intermittent catheterization to void at the time. The severe adverse events reported, I included only the ones that required hospitalization or prolonged hospitalization, were a 7.7% rate. 26 in total, most commonly post-embolization syndrome. This is a pretty common clinical picture where patients can have mostly relative symptoms, difficulty voiding or pelvic pain, sometimes accompanied by fever following embolization. Some cases of urosepsis, retention, and contrast nephropathy. The rest were very uncommon. And these are their outcomes collected.
You can see the symptom scores, the maximum flow, PVR, and prostate volume. At baseline, short-term captures within six months after the procedure, medium-term is within two years and five years for the long-term. As you can see, all the parameters had a clear improvement in the short-term and a slow decline thereafter. We know that's to be expected with a progressive disease as BPH. I find this to also be a relevant outcome to document. This is the rate of retreatment over time. The left captures surgical retreatment, so patients undergoing another surgical modality. This rate was 9.5 at two years and 18% at five years, whereas on the right are the patients restarting medical therapy. That was 14% of the patients at two years and 30% at five years. Conclusions of this article is that this procedure can be performed safely. This cohort is the largest in the literature that I could find of patients depending on catheter. 60% of them were catheter-free at six months measured. The side-effect profile, it's pretty safe, and it provided significant symptomatic relief on the short-term. The retreatment rate at five years. We talked about it, it's increased. I would say in the literature, this compares higher than for surgical interventions such as TURP, enucleation and so forth. It is a valid option for patients that can be very severely symptomatic. I
t can be applied for very large prostates that prefer to opt for a minimally invasive treatment because of patient preference or possibly if they're not good surgical candidates for a major procedure, this constitutes a viable alternative. Much credit to our colleagues from Denmark, it really is impressive to include all the patients nationwide in a same study, really remarkable data and very, I think, enlightening of how the long-term picture looks after this procedure. This is the full reference. And again, thank you for the invitation.
Alan Wein: Thank you so much. So what are the size limits? In other words, how large a prostate would you refer someone for what's the upper size limit? And also, is there a lower size limit?
Diana Lopategui: I don't think the interventional radiologists have specific size parameters on their limitations. The referrals tend to be in the larger size of prostate as these patients have less options in the landscape nowadays. They might not have a lot of alternatives if they're maybe very medically complex and a larger prostate. To my knowledge, and obviously if our colleagues need to correct me, I don't think there's a size limit. These authors did look at the impact of size in the outcomes in terms of prostate reduction and symptom reduction, and they did find an association from the decrease in size and the symptomatic relief that they did find an association. They also pointed out how very severe symptom scores at baseline seem to have a lesser degree of relief. They pointed out how that's something to have in consideration. Very large prostates have a more significant reduction in volume, which seems to be a more appropriate candidate for this procedure, but if they have a very extreme severity of symptoms, it just seems to show slightly lesser benefit.
Alan Wein: It looked as though from the graphs that you showed that there's a pretty good result at six months, and then everything deteriorates after that. So it looks almost as if the symptoms really go back to pretty much of what the baseline was prior. Do the patients in urinary retention that come out of retention, I think you said it was about 60%, do they then go back into urinary retention or do their symptoms just get worse?
Diana Lopategui: That has definitely been documented. That I can only say anecdotally from my practice because I don't think this data was collected in the long-term, at least not in this study, but we do see that in the long-term follow-up. With the worsening of the symptoms that happens in the long-term, there is some amount of people who go back into retention, yeah.
Alan Wein: Now, this is done mostly under sedation, under anesthesia?
Diana Lopategui: It is occasionally under only local. Most people find benefit of light sedation just to be more comfortable.
Alan Wein: Right.
Diana Lopategui: Yeah, that is a very significant benefit in my eyes. I do consider that as a very valid alternative for men with severe symptoms, retention, like you mentioned, maybe very advanced age, maybe not even a very long life expectancy.
Alan Wein: Right.
Diana Lopategui: But being in urinary retention can be very impactful on their quality of life. And being able to have an option for even a very large prostate that doesn't require anesthesia is very hopeful for people, and a 60% chance at having that catheter removed is meaningful.
Alan Wein: Right. So how long does it take the average skilled interventional radiologist to do this, total procedure length?
Diana Lopategui: It is highly variable. I do have an immense respect for our interventional radiology colleagues because from what I know about the procedure, it seems extremely, extremely challenging. There's great variability of the prostatic vasculature anatomy and the prostate arteries are less than two millimeters, so to cannulate that and embolize it appropriately on both sides. The authors of this study did document the length of their procedure. It was a median of 134 minutes with an interquartile range of 113 to 160 so just a little over two hours. It does have a significant learning curve where physicians just starting can find sometimes that the procedure can take three and four hours, after getting over the learning curve of the first dozens, couple hundreds of cases even, they get to an average of physicians with lots of expertise and long series can perform it in under an hour.
Alan Wein: So it's really important to find an interventional radiologist who has a big experience of having done this and having it done successfully in his or her pocket.
Diana Lopategui: Yeah, absolutely. There are some centers in the country that do thousands a year. Obviously, not everyone will have access to that kind of environment, but that definitely makes a difference in terms of procedure length and also radiation, which is a procedure that's guided with fluoroscopy. It can have a significant amount of radiation to the pelvis. Obviously, that's not something that we'll see the effects in the very short term, but it is another variable to consider for some people.
Alan Wein: So where in the hierarchy now of all these procedures that we have available for outlet reduction, where would this exactly fit?
Diana Lopategui: The latest American urology guidelines for BPH give it a recommendation as an option. This is an option that can be given for patients wishing for a minimally invasive treatment. It gives it a recommendation grade C. So that's below a recommendation for enucleation treatment or something more traditionally urology-geared. So it does definitely become a valid alternative. There is a lot of marketing materials out there. If you look into this, there's advertisements, there's a lot of targeting of patients debating this as a superior alternative that can be applied to everyone. Obviously, that doesn't apply to any surgery out there. I encourage people to consider all their options, definitely bring it up to their physicians if they think they would be interested. It's definitely only an option. There is a lot of literature in the last few years following these patients like what we just discussed, also comparing it to TURP, comparing it to enucleation.
Most of them coming out of Miami. As you mentioned, there's an incredible team and collaborative efforts ongoing between interventional radiology and urology. The data as a whole seems to be moving towards somewhat of an equivalence on terms of symptomatic outcomes. Some groups have found close to an equivalence. In some terms, immediate flow and PVR and things like that don't seem to be equivalent. And in terms of durability, I do believe that the jury is still out if they're equivalent in terms of outcomes. In terms of side effects, it does appear that PAE is somewhat safer. There tends to be finding more side effects from a procedure like a TURP or a HoLEP. It's obviously more invasive, so not unexpected. And in terms of durability, that's where I think a more invasive surgical procedure provides an advantage.
Alan Wein: Last question. For people that have decent erections before and antegrade, are either of those disturbed with the usual PAE procedure?
Diana Lopategui: What's been shown in the literature is that those are very uncommonly affected. That is another benefit. It does have the potential to preserve antegrade ejaculation, and that is a good point on this article that we discussed. They did look at the sexual side effects, and they found an improvement as well in those particular domains. And some studies comparing to TURP have shown that there seems to be a slight trend to decrease in satisfaction after TURP related most likely to the onset of retrograde that is not seen that often with PAE.
Alan Wein: Well, again, thanks so much for a splendid presentation and a great question-and-answer period. We're indebted to you, and may come looking for you again. Thanks so much.
Diana Lopategui: I'm so glad. Thank you so much for your time and kindness, and this is a pleasure. Thank you so much. You have a good day.