Surgeon: Kevin McVary

Moderator: Ullrich Witzsch


Dr. Kevin T. McVary, MD-FACS graduated with distinction from Northwestern University, received his M.D. degree from Northwestern Medical School and completed a 6-year program in Urology and general surgery at Northwestern University and Northwestern Memorial Hospital. Dr. McVary joined the staff at Northwestern Memorial Hospital and was a Professor of Urology at Northwestern University Feinberg School of Medicine for 23 years. He served as the Director of the Center for Sexual Health at Northwestern Memorial Hospital, conducted the Prostate Diseases Minimally Invasive Program, and Director of the Andrology Fellowship Program at Northwestern Memorial Hospital, Southern Illinois University School of Medicine and now at Loyola University Medical Center. In 2012 he was named the Chairman of Urology at the Southern Illinois University School of Medicine located in Springfield, IL, his hometown. In 2018 he returned to Chicagoland to become the Director of the Center for Male Health, Professor of Urology at the Stritch School of Medicine at Loyola University Medical Center.

His primary clinical areas include prostate diseases including prostate cancer and BPH as well as the evaluation and treatment of sexual function. Dr. McVary has had an extensive experience conducting clinical trials for the National Institute and Health and numerous private and industry foundations. An experienced investigator in prostatic disorders and erectile dysfunction (ED), Dr. McVary is currently and has recently been principal investigator for more than 75 clinical trials. Dr. McVary’s research has generated more than 400 publications including refereed journal articles, books, book chapters, and abstracts. Dr McVary is the Chairman of the AUA BPH Clinical Guidelines Committee, the Co-Chair of the International Consultation on Male LUTS, Panel Member of the AUA Clinical Guidelines for Erectile Dysfunction, and Panel Member for AUA Clinical Guidelines for Peyronie’s disease. He is Associate Editor of the Journal of Urology and Section Editor for Current Urology Reports. He has been named Chairman of the Special Emphasis Urology Study Section for the NIDDK. He is Co-Chairman of the Clinical Section of the NIDDK Strategic Pathway for Prostate Basic and Clinical Science. He has also completed a 4 year stint on the American Board of Urology Exam Committee.

He has held positions for several federal agencies exploring issues of sexual medicine including the Surgeon General’s Report on the Health Consequences of Smoking for the United States Department of Health and Human Services on the Science of Erectile Dysfunction. His honors include: 1) Member of the Clinical Society of Genito-Urinary Surgeons, a professional society limited to 26 active members; and 2) Member of the American Association of Genito-Urinary Surgeons, a professional society limited to 70 members. Membership in these two societies is through nomination by peers based upon lifetime achievement and other factors. He is the Past President of the Chicago Urological Society. He has been the AUA Honorary Speaker at the European Association of Urology (EAU) chosen by EAU members as well as the SMSNA Honorary Speaker chosen by the European Sexual Medicine Society (ESSM) membership.

 

Ulrich K.Fr. Witzsch MD finished High School in 1980. He served in the medical Services of the German Army before he went to Medical School at the Johannes Gutenberg University in Mainz. He did the surgical part of the final year at Mary Imogene Bassett Hospital, Cooperstown, New York. He finished his residency at the department of Urology and Pediatric Urology (Chair Prof. Hohenfellner) in 1995 including a rotation in the department of surgery at Kreiskrankenhaus Melsungen. Afterwards he joined the staff at the urology department of the Horst Schmidt Kliniken in Wiesbaden (Chair: Prof. Köllermann) In 1996 he moved to the department of urology and pediatric urology at Krankenhaus Nordwest in Frankfurt (Chair Prof.Dr. Dr.E. Becht) where he is the permanent representative of the chief since 1999. He is coordinator of the Prostate Cancer Center and the Urooncolgy Center, certified by the German Cancer Society.

He got an degree in Qualitymangement and underwent the training for Clinical and Business risk management.

His clinical areas include almost all fields in urology but specially technical innovations and minimal invasive therapy. He participated in several studies, publications and book chapters in various fields like: Vascular aspects of erectile Dysfunction; Ultrasound guided extracorporeal shockwave lithotripsy of urinary stones (FDA Approval); Extracorporeal shockwave therapy of pseudoarthrosis and tendinosis; Clinical information system in urology, electronic generation of medical reports; Surgical therapy of female and male stress incontinence; Nephron spearing surgery; Cryoablation of the prostate; Contrast enhancend transrectal ultrasound; Greenlightlaser treatment of BPH; Focal Therapy; MRgFUS (MR guided Focused Ultrasound) and others.

Ulrich Witzsch organized training courses for penile implants and sphincters. He started the European training system for Third generation Cryotherapy of the prostate. He is Proctor for Cryoablation of the Prostate, Greenlightlaser and transurethral Intraprostatic Watervaporisation of the Prostate.

He was member of the ESUT ablative group.

He is Chair of the Workgroup on Informatics and Documentation of the German Academy of Urology. Also he is founding member of the Workgroup on Translational Research, Quality and Economy and founding member of the Workgroup on Focal an Microtherapy. Also he is founding member of EUCAP.


Webinar Transcript

Dr. Amy Krambeck:

Hello. My name is Dr. Amy Krambeck and I am a professor of urology at Indiana University. Today is our Master's class in endourology. This event is sponsored by The Endourology Society as well as the Society for Robotic Surgeons. We would like to think Boston Scientific for their grant and support of this educational activity. The purpose of this class is to provide our attendees an online program dedicated to surgical techniques in endourology and robotics. Their target audience is physicians or urologists specializing in endourology and robotics. At the end of this procedure, you should be able to identify examples of new technology, the critical steps and techniques and the differences in application. This is accredited, so you will get CME credits for your participation.

Dr. Amy Krambeck:

You will receive a survey from Michelle Paoli at the end of this webinar. 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.

Dr. Amy Krambeck:

Today we will be discussing thermal procedures in the treatment of BPH. Our faculty is Dr. Kevin Nick McVary. Dr. McVary is the director of the Center for Male Health and professor of urology at the Stritch School of Medicine at Loyola university Medical Center in Chicago. His primary clinical areas include prostate diseases, which include prostate cancer and BPH as well as the evaluation and treatment of sexual function. Dr. McVary is the chairman of the AUA BPH clinical guidelines committee. The co-chair of the international consultation on male Lutz, and he is the associate editor of the journal urology and section editor for current urology reports.

Dr. Amy Krambeck:

Our moderator today is Dr. Dr. Ulrich Witzsch. Dr. Witzsch is a professor of urology at Krankenhaus Nordwest in Frankfurt, where he is the permanent representative of the chief since 1999. He is the coordinator of the prostate cancer center and the uro-oncology center. His clinical areas of interest include technical innovations and minimally invasive therapies. Dr. Witzsch is the chair of the working group on informatics and documentation of the German Academy of Endourology. Also, he is founding member of the work group on translational research, quality and economy and founding member of the work group on focal and micro therapies. I think we will have a wonderful presentation today.

Dr. Amy Krambeck:

We will start today's presentation with a poll. The question is, are you treating bladder outlet obstruction surgically? And this is multiple choice. And it looks like about 88% are treating bladder outlet obstruction surgically, and about 13% are not. Okay, we'll go to our next question. How many options for surgical therapy a bladder outlet obstruction do you use? So how many different treatment options are you currently using in your armamentarium as a urologist for BPH? And it looks like a large percentage are using about three options, about 43%, about 23%, two options, and then some are even using up to seven different options.

Dr. Amy Krambeck:

And then for our third polling question, do you use transurethral water vaporization of the prostate, yes or no? This is a new technology and may not be as many people using it, but it looks like we're going to have a good response here. So our audience is familiar with it. So it looks like about 79% of the people do not use water vaporization and 21% do. So we all have quite a bit to learn here and I can't wait to hear what our experts have to say. Dr. McVary, why don't you go ahead and start with your presentation.

Dr. Kevin McVary:

Again, Amy, thanks for the nice introduction and the invitation to speak today on MIST and Rezum, otherwise known as water vapor thermal therapy. Disclosure's always important to show. So Rezum, what is it? Primarily office based therapy consists of a generator, a [inaudible 00:04:40] type event with a retractable needle. And little video shows as that needle is retracted and inserted strategically into parts of the prostate which are blocking flow. If we can't get this to move, I'm going to move right on. Our video's not playing so well. But the idea is to treat serially and strategically into the transition zone.

Dr. Kevin McVary:

The technology is interesting and that it's steam only stays in the transition zone. It doesn't transfer out, at least at this volume and pressure. What do we see? Well, we see a significant improvement in lower urinary tract symptoms, IPSS. Our symptom scores drop promptly, and then stay suppressed for up to five years. That's the end of the pivotal trial. This was presented at the AUA this year, manuscript forthcoming. Objectively, we also see a substantial improvement in flow, which also stay stable for the following 60 months.

Dr. Kevin McVary:

Important news, sexual function does not look like it changes no matter how we measure it. Erection, ejaculation, bother, sexual function, is stable throughout the post treatment. And again, re-treatment a critical issue on any MIST because of failures in the past with other types of MIST. 4.4 surgical re-treatment at five years and 11% medical treatments, medical restarts in a sense, again, at five years.

Dr. Kevin McVary:

How do you do this? So the in-office setting that I would advise is something like this and I've circled the popliteal support. We do it in the office probably 90% of my patients. In the US, it's an 88% nationally I understand. But popliteal support is a critical improvement in my own planning in my office. And I would tell you to do that.

Dr. Kevin McVary:

The guidelines now tell us that prostate volume planning is critical. And that's because treatment is determined in part by prostate volume. Prostate volume is an important part of the treatment regimen. It allows you to predict, is this going to be an inappropriate patient? And second, it gives you an idea of likely outcome. Doing cystoscopy also part of the AUA guidelines. New addition to the AUA guidelines tells us that about strategy, but also gives us an idea, is the patient going to be able to tolerate the procedure in the office? So you get a freebie, a look, a future look, is this the kind of guy that's going to be comfortable in the office setting? And I'm just going to plan one way or the other from the get go-

Dr. Amy Krambeck:

Doctor [inaudible 00:07:43] ask you a question before you move forward. You used the term popliteal support?

Dr. Kevin McVary:

Yeah.

Dr. Amy Krambeck:

What do you mean by that?

Dr. Kevin McVary:

The idea is to support the popliteals that relaxes the pelvis, and you can instrument with a rigid instrument a little bit easier. Well, actually a lot easier when you do that. And I'll demonstrate that in a couple of slides. So, is a video I showed, I called it Easy Peasy. Up here in this quadrant, shows the treatment plan. I was going to do two treatments at the three o'clock position and two treatments on the nine o'clock position. And he had a median bar and so he'll get a single treatment there.

Dr. Kevin McVary:

So the idea is where's my veru, planning out my procedure. I turned the scope to the three o'clock position, pulled the scope back two fields of view. It takes it the sonometer off the bladder neck, and that's where it's safe to start. I'm giving them a simple treatment here. Takes nine seconds as you're aware. When I finished the first treatment, I like to go back, find my veru and then proceed proximately as a safety measure. So instead of just pulling it straight back to the second treatment, I go back and find the veru and then go proximal. And I have a lot of solace in knowing, "Hey, I am not getting close to the [inaudible 00:09:11] sphincter when I'm doing it that way." So, again, we take nine seconds and move to the opposite side, reposition the scope at the bladder neck, get oriented, turn to the nine o'clock position, slowly.

Dr. Kevin McVary:

And then again, two fields of view, do a treatment. And again, you can see the mucosa filling with the steam. Again, that steam intercalates through the transition zone. At least at this volume, it does not cross into the peripheral. And again, I find my veru, a little safety check, turn back to the nine o'clock position, give that fourth treatment into the transition zone. And then back to the bladder neck. The idea of the bladder neck is usually a lateral to medial shot. So I go up and to get as far lateral at the bladder neck as I can pull, back two fields of view or so, and then like a tangential shot, an angling shot, into the middle tissue. So this is five treatments for 31 grand prostate. I have another couple of cases where I demonstrate variations in that.

Dr. Kevin McVary:

Our next case, this is a more complex structured prostate. I called it interlocking lateral lobes where the hyperplasia was such that the lobes all interdigitated, not just at bladder neck, but also like a lock and key. And an interesting anatomy, so I took a video of it and display it here. In the right hand quadrant, you can see the treatment plan. Still going to do the two treatments in the three o'clock position as shown and two treatments in the nine o'clock position as shown. But when I bring my scope back to the verumontanum, I can see that they're still additional enlargement where these things, I called interlocking. And I decided, "Hey, I'm going to treat those as well."

Dr. Kevin McVary:

And the idea is it's a more challenging anatomy, it's a more challenging confirmation of the gland. And you can customize treatment to the prostate that you see right there. It isn't like one size fits all. I'd it very urologically, if that's a word. I invented, I think. But very personalized. You can personalize the treatment to the exact anatomy that you see in front of you. So, we're moving on to the opposite side and same idea, a couple of treatments, find my veru. Going to do my fourth treatment, the second one at the nine o'clock position. And now there's that interlocking position, the interlocking prostate tissue. You can see they're grown in there, nasty, gnarly looking prostatic urethra. You can see it sticking out. I'm going to hit that thing. And I'm also going to do a similar one on the opposite side, but I think you get the point, is that you can customize it.

Dr. Kevin McVary:

There's a current theory, hypothesis, that may be doing less is better for patients. So this is a man, 31 grams, very attuned to his sexual function. And so I'm going to do it more minimal treatment to this prostate, same volume, 31 grams. And I'm going to do a single treatment on one side and a single treatment on the other. There's I'd say no question that this is less Edema, easier catheter time afterwards. I'm hoping that we're not compromising durability by this mentalist approach. But you get the idea, one treatment each side. And again, that corresponds to the diagram that you see here. It's standard Rezum treatment otherwise.

Dr. Kevin McVary:

Now, what about the middle lobe? If you have a large middle lobe, this is a short sequence. I don't want to repeat the whole glam, but the idea is if you have a big median tissue and you have a cleft on each side of that middle lobe, position the scope in the cleft at the bladder neck, pull back the fields of view that I described, showing here. And then, again, a lateral to medial side shot into the prostate, into that middle lobe tissue. Once delivered there, I'm pulling it back safe off the bladder neck and I'm going to give him a shot right there. Then after the nine seconds, I go to the opposite side, position the scope in the cleft, pull back for safety sake, deliver additional treatment on the opposite side.

Dr. Kevin McVary:

So on a middle lobe, one that's sizeable, it's usually just two treatments. Now, if you have a very large inter prostetic protrusion, I mean, I have done free treatments, and you can do that. But, most men I've seen with middle lobes, you will really only have to use the two treatments. Be cautious about over-treatment on the middle lobe, I would say. Big ones, go ahead and do it.

Dr. Kevin McVary:

Yeah, this is one of my favorite scenarios. A guy had a lift when an immediate urinary retention, totally focused on a sexual life. He came to me after six months, retention since his lift. Was telling me, "Oh my God, my life's ruined." He was on intermittent catheterization. I scoped him. He had exposed metal fragments. I removed those. Some are encrusted, some are just exposed as the photo shows. I gave him a couple months to chill out. Didn't get better, still on retention. So I said, "Okay, let's try a steam on you."

Dr. Kevin McVary:

So, couple of tips if you run into these. I would cysto him as a separate procedure, look for exposed foreign body. Lots of different tools you can use to get those steel. I actually pulled some of the titanium hooks out as well in some patients. I just use graspers, but other people describe lasers or even resectoscopes. Be careful where those exposed metal are and which ones are working and which ones are not working. By working, I mean no longer exposed. And I, again, suggest you rest it after you removed those fragments, because maybe the patient after a lift is going to improve and you get some of the bad stuff out.

Dr. Kevin McVary:

So here's my problem child. I'm scoping him after that period of rest. And you can see he's got a big middle lobe. So for whatever reasons, the initial surgeon didn't treat it or didn't notice it, or maybe it looked worse once you did some lateral retraction. But, I'm going for it here. And I'm pulling that scope back. The safe distance, given them a single treatment on near the bladder neck. Then I'm going to find my veru. And there's a teaching point I wanted to say here, I call it anecdotally anecdotal, but somehow I feel compelled to say it. And that's as I pull back to the verumontanum. I position like I've described for the safety. I'm getting ready to do a second treatment on that side. You can see that little indentation. That's a lift there. But I poke the needle in, aboard of the steam. I didn't press any steam, reposition into a different part away from that seemingly working component, or at least not exposed component and did my second treatment there. So, trying to avoid re-exposing any metal by steaming too close to the [inaudible 00:17:34]. That guy actually did great.

Dr. Kevin McVary:

So, Amy, this is what I was talking about, the popliteal support on a table that allows you to get the man's buttocks right to the edge of the table and he can relax. When he's in the stirrup kind, they push off. And if they push away, that pelvis tightens, it's hard to introduce a rigid scope. So, the idea is slow insertion for those that ... I'm old enough to have done a bucket of rigid cystoscopies in the office before flexible was available. But anyway, those are some of the tricks and I pass them along. Sometimes it's difficult with middle lobe tissue to get the scope to go in. And it's painful. One trick is to treat your way in, cross to the other side, treat your way out. A little trick and had to do that a few times basically when the patients are awake and suddenly it's a little difficult to get it in there. It's a nice little trick to try.

Dr. Kevin McVary:

What about vapor leakage? Steam can whisk alongside the needle. And it's my thinking that steam that's not getting into the tissue is wasted energy and maybe a suboptimal treatment. So by micro adjustment of the scope, you can compress it and block off some of that leakage of steam that may be coming out around your needle. Just I guess a tip. I'm concerned that that would lead to your refill slough, but basically wasted energy. So, just a little tip.

Dr. Kevin McVary:

I think one of the keys to success with steam is setting the patient right from the beginning. And I'm realistic. I'm saying, "Hey, you're going to have a catheter. The average is three days. You may need more if I do more treatment." I tell them, "Give me two weeks without complaints. I know that you're going to have frequency and urgency afterwards. And after that period of time, you'll begin to maybe like me again." Men that have overactivity, preoperatively seem to have a longer recovery time until they state that they've had a good relief from their urgency. And if you have your dynamics on them, you can counsel them appropriately. And then even though you say it a hundred times, you're going to see blood. It's blood normally after this. You'll get calls, "Hey, I see blood." But regardless, I try to set the record straight. So again, one field of view is half a sonometer. And so when you're pulling off, it's two fields of view. That gives you safety away from the bladder neck.

Dr. Kevin McVary:

How does this compare to medicine? Well, the only thing we really have is a single report where we did an analysis of versus the MTOPS cohort. We tried to match them as best we could. Bottom line is this particular MIST really blows medical therapy out of the water. This was at two years for Rezum and we took the MTOPS outcomes at the two years as our comparison. In terms of clinical progression, Rezum blew it out of the water. In terms of improving the symptom score, retention and continence or urinary tract infection, MIST beats medical therapy, hands down.

Dr. Kevin McVary:

If we look at symptom scores themselves by treatment group, you can see Rezum versus the alpha blocker, Finasteride or combination. And symptom scores are better with Rezum with monotherapies, comparable with combination therapy. Although flow rate is better with Rezum than the combination medical therapy. But, the real advantage, when you look at sexual function, because medical therapy has an impact on sexual function. And you can see that versus placebo, Rezum is comparable. It's less impactful on sexual function than five ARIs. I suppose that's not a surprise. It's actually better than alpha blocker and certainly better than it is in combination, the combination of medical therapy, which actually has the best impact on symptoms. So, I think that this is an important point for us to know that this may be a big advantage to choosing MIST over long-term medical therapy.

Dr. Kevin McVary:

So what about the catheter? Well, someone asked me, "What's your protocol?" And I was like, "Well, I don't know. What is my protocol?" But basically go back to the pivotal trial. Those was a 45 gram prostate, and the man had the catheter for three and a half days on average. So I said, "That's where I started my practice. Your prostate's this, I treated it five times. You're keeping the catheter for three days." If the man has known hypotonia to choose a underactivity, excuse me, preoperatively, then I would certainly say, "Hey, got to keep it in longer."

Dr. Kevin McVary:

So, other factors which may determine catheter duration. Well, you do the Rezum on a Friday, he's not getting the catheter out until Monday. And keep the patient out of the emergency room. You don't want to have them take it at home, catheter out at home, and then have a question, he ends up in the ER. I guarantee you the ER will put a catheter in him. Time that, according to the day of the week, may determine catheter duration.

Dr. Kevin McVary:

I've already mentioned, men whether to choose underactivity or known to choose underactivity on pressure flow studies, they deserved the catheter a little bit longer. I've learned that. Also men in retention who failed a previous trial without catheter, again, same thing. I leave that catheter in usually seven days on those guys that presented in retention. It's never wrong to teach a patient intermittent catheterization, if they'll do it. Just don't teach it to them in the recovery room. And then a lot of my patients come from elsewhere, from coast. And so they're traveling to Chicago. You got to have an ally back home. They're going to decaf there. But anyway, you'll have to work that out for yourself in terms of your geographic location versus your patients. But you have to take that into consideration. That yes, retention. You can treat patients in retention.

Dr. Kevin McVary:

This is a registry study we just published, not part of the pivotal trial. Old men, big prostates, sick, ASA classes, threes and fours. Some with a catheter for two and a half years. So, hardcore group. We could decaf them successfully. About 68%, 66%. But that successful trial without catheter, average, 26 days. So it is possible, but it's a special cohort. It's new, it's innovative, it's versatile, it's office-based. At least in my own practice after I got comfortable with it. And I'd say, very durable. Low surgical re-treatments, low medical re-treatments with a low impact on sexual function. So, if you haven't adopted it, I'd asked you to. It'd be worth trying. Your patients would appreciate it. And that's all I got to say. Thank you, Amy.

Dr. Amy Krambeck:

Well, thank you. That was extremely informative. And we have a few questions that have come through.

Dr. Ulrich Witzsch:

Well, looking at the indication, do you think there's any limitation to size?

Dr. Kevin McVary:

Well, the pivotal trial was from 30 to 80 grams and that's what the guidelines suggest. That said, I've done up to 100 ... I've actually done 140 grams. I don't advise 140 grams, special circumstances. But, I'm comfortable doing up to 100. But as you get bigger, it's more treatments and then you start to lose some of that advantages of a MIST, that early recovery. Some of those fast recovery things, you start to lose because of more treatment, more Edema, longer catheter duration. And it's appropriate if patients are counseled. But I think there are limits, you just don't know where the limit is.

Dr. Ulrich Witzsch:

Yeah, exactly. In the last group you described, they have a high co-morbidity, do you think there's any limitation?

Dr. Kevin McVary:

With co-morbidities, is there a reason to maybe consider doing this preferential? I don't know. You can do it in the office, that's for sure. I did these older gentlemen in the office. Most of these men aren't getting a laser or another standard TURP because of the anesthetic risk and their frail nature.

Dr. Amy Krambeck:

What about patients who are on anticoagulation or anti-platelet medication?

Dr. Kevin McVary:

The guidelines say, pull them off any of those medications if it's allowed, if the cardiologists will allow you. I have had my hand forced where that was not allowed. I've certainly done lots of patients on Plavix. It's like, just pull them off and they can go back on right afterwards, certainly. The issue is when they can't come off and for whatever reason, you got to go ahead and do it. And I would say, ask yourself, is it really important that you do it? Anytime you touch those guys who are on Plavix and anti-platelet medications, they bleed more. Even if you do a MIST. So you can get away with it. I would do everything I could to avoid having to do that.

Dr. Amy Krambeck:

And so that parlays into the next question. What size scope do you actually use for this and is it continuous flow?

Dr. Kevin McVary:

The scope is not. Well, it has a trigger valve on it where you can pulsate fluid. There's a motorized pump that pulsates and pushes that fluid through, but you control that. There's a slow rate and a fast rate. If you had a clot, you just double click and you get a pulse of water and blows the blood clot right out of your view. So, goes okay.

Dr. Ulrich Witzsch:

If the prostrate is very big, do you do just one row of injections or do you do a second row if the prostate is very high? Is it more or do you need more treatment?

Dr. Kevin McVary:

Well, the limit is 15 pokes per instrument. It times out. You can't use it after that. I've never had to go more than 15. For 100 gram prostate, let's say that's the really practical limit I've been doing, I've never had to do second rows. I have customized it like I showed you on the interlocking one, things like that, but to plant two rows like that, I don't know if that's necessary as a routine. I wouldn't try to ablate the entire transition zone. What I would try to do is have enough regression that he gets a urination pathway. So I don't feel like I'm tapping him.

Dr. Ulrich Witzsch:

In those patients you put in [inaudible 00:28:16] catheter?

Dr. Kevin McVary:

I use a 16 or an 18 [inaudible 00:28:21] on every man.

Dr. Ulrich Witzsch:

Okay. And even in those who come with retention?

Dr. Kevin McVary:

Yeah. Mm-hmm (affirmative). Who present with retention, absolutely. Yeah.

Dr. Ulrich Witzsch:

Okay.

Dr. Amy Krambeck:

And do you ever get histologic material available or do you have to do a biopsy?

Dr. Kevin McVary:

If there's a need for a histologic diagnosis, you just set a lap beforehand. This isn't the time to do it.

Dr. Amy Krambeck:

Got it. Got it. These are just questions that have come in through the chat. Do you have any experience with doing a Rezum after a failed Rezum?

Dr. Kevin McVary:

Yes. I'm going to do one in about five minutes. So yes. My philosophy there is, well, if the technology didn't work the first time, why are you repeating it? So, the fellow I'm about to do, had a treatment and he had his middle lobe undertreated and he has obstructive symptoms still. I verified that by pressure flow and scoped them. And I'm just going in, do the middle lobe and get out. I wouldn't go and retreat tissue that looks like it's treated. It would have to look like naive tissue just as I've done steam after a PVP, for instance. But, I don't want to treat regrowth because I don't know if the intercalation of steam is going to work correctly, but I will do undertreated naive tissue.

Dr. Amy Krambeck:

Okay. Is there an amount of time that you would wait between the first treatment and the re-treatment?

Dr. Kevin McVary:

Well, for sure, three months because that's really where patients have really hit their plateau, or [inaudible 00:29:57], I should say. So I would wait then. I would really counsel maybe six months before you go in. I wouldn't be fast to retreat. I would be fast to wonder, did I make the wrong diagnosis? That one is worth it. But again, the AUA guidelines, actually it's AUA update, excellent one written by Alex [Tey 00:30:14] validated that, or supposedly validated, that a three month wait is appropriate before re-establishing or reassessing outcome for re-treatment.

Dr. Amy Krambeck:

And then, I saw [crosstalk 00:30:29] the data you presented on outcomes and it looks like the sexual function is phenomenal. What do you counsel your patients about the risk of retrograde, is there a risk at all for retrograde ejaculation?

Dr. Kevin McVary:

That's an excellent point. So if you look at the ejaculation scale, it's a straight line, but is wide standard deviations, which tells me that scale's imprecise or men don't know what the hell they're talking about. And it could be either. So it is low. On average, they don't change. But, you can still have a guy who says, "Hey, it's better," and a guy who says, "not so good." So yeah, we see that. And it really falls into the adverse events category because the scales we use really aren't catching it. So I tell patients, erectile changes, not likely, ejaculatory, changes are possible, and they'd have to accept that. Men are freaked out about that. They can donate, bank sperm or something, but they're really freaked out. Anyway, that's just my advice on that.

Dr. Ulrich Witzsch:

And if you compare the Rezum method and others, what would you suggest is the method with the lowest risk of ejaculation disorder?

Dr. Kevin McVary:

I'll rephrase the question because there was some cutout, but it's a good and yet really common question, is in terms of sexual function, how do the two current MIST, which is really Lift and Rezum compare? And if you look at those scales, on both of them, they are straight lines across. The same scale issues of function in both cases. It's an imprecise tool. Their advantage is really a lack of an impact on sexual function, erectile function. There's probably more ejaculatory complaint after a Rezum compared to a Lift, although durability looks like it's a big advantage to steam over Lift.

Dr. Ulrich Witzsch:

When you look at a very small prostate, aren't you afraid of incontinence due to sphincter damage?

Dr. Kevin McVary:

Well, I don't treat under 30, so no. But yeah, if you misplace that needle, if you're not poking it in the transition zone, where's it going? If you poke it into the peripheral zone, it'll stay in the peripheral zone. But if you're outside the prostate, I mean, I don't know. That actually hasn't been done and I don't want to learn. So you have to be cautious. And that's why I'm focusing on two fields of view, away from the bladder neck and then find the veru and go proximal, because you want to stay away from that.

Dr. Ulrich Witzsch:

So the minimum length you need is 1.5 centimeters, right?

Dr. Kevin McVary:

Well, it's really volume, but yeah.

Dr. Amy Krambeck:

Do you use any anesthetic gel or nerve block for these cases?

Dr. Kevin McVary:

I don't do anything but a prostatic block with lidocaine. It's all I do. I used to use Valium type medications and my nurses didn't like me. Because then they're spending all their time with these guys that aren't waking up. So I completely stopped it. I just do the randy beer ... We call it the beer block, but basically it's twice the normal amount of lidocaine that you'd use on a prostate biopsy, five CCs of lidocaine above the vesicle, five in the standard position on both sides. They purr like kitty cats after that. So I would tell you just use the beer block. If I can't get them on a beer block, I'm not going to do them in the office. I'm going to do them in the ASC.

Dr. Amy Krambeck:

Okay. And you said this at the beginning of your presentation, but just if you could reiterate, what percentage do you do asleep under anesthesia or sedation versus in the office?

Dr. Kevin McVary:

About 90% of minor in the office at this point. Anxious guys or guys where they're just down tolerate blood draws, let alone cystoscopy. Again, you discover those when you do a preoperative cystoscopy. And then if they're a sizable gland, if they're up like above 80 grams, that's a lot of poking to hold still. So the bigger prostates, I'll just plan on doing them in the ASC.

Dr. Ulrich Witzsch:

That's interesting. In Germany, it's mostly done as an inpatient procedure, not in the office. But this might be also that the postoperative care in your country is a little bit better than in Germany.

Dr. Kevin McVary:

Well, I think also reimbursement's different in Germany where it's better ... It's not reimbursed unless it's in the hospital. That's my understanding. And the opposite is true in the US. But it's totally doable in the office. It's one of the criteria for a MIST. Can you do it in the office?

Dr. Amy Krambeck:

One question that came in is, do you see it as an in therapy or do you see it as a bridge between medical therapy before you get to [inaudible 00:35:48] or resection of some sort?

Dr. Kevin McVary:

No. I think it's a competitor against more standard resection in my own view. I don't like serial therapy. That's why I stopped doing microwaves and I stopped doing TUNAs, is because I was retreating a couple years later, was turning it into a urologic annuity. And I abhor that. So that's why I think re-treatment is a critical health policy for us. We have to look at what are our re-treatment rates. And I have no interest in doing a MIST followed up by a [inaudible 00:36:25] a few years later. That feels like I'm not doing my patients well. And now if a patient says, "Hey, I want two years of [inaudible 00:36:34]" All right. I'm okay with that, but if he understands. I know the impact isn't as robust in terms of IPSS between two classes of therapy, but patients are willing to accept that. They'll take less impact for less risk.

Dr. Amy Krambeck:

Got it.

Dr. Ulrich Witzsch:

But I think on the other hand, in the very old patients with a big prostate, instead of [inaudible 00:37:07], they have the chance to treat the patient and give them a chance to work properly without any catheter then.

Dr. Kevin McVary:

I agree. And that's why I wanted to show that chronic retention slide because in a frail group, you can do it.

Dr. Ulrich Witzsch:

Yeah, that's exactly the main group we did in the beginning, yeah. I was also astonished that 100% of the patients, even after sometime, [inaudible 00:37:32] you'd have a year, could work properly, 100%. Though this was really astonishing.

Dr. Kevin McVary:

Well, in our series it was like 67%. So apparently our steam is not as hot as it is elsewhere. But our electricity [inaudible 00:37:49] something. But, anyway, the idea is you can get it for a lot of patients.

Dr. Ulrich Witzsch:

Do you see a difference in patients who are treated with 5-ARI or other medications before?

Dr. Kevin McVary:

I wondered that. I wondered with the 5-ARIs, do you have a more fibrous gland and maybe steam won't intercalate? But I haven't noticed that difference. But, I've always wondered that with this technique. We used to say, "Oh, you can tell." But, I don't know if that's true. Certainly, the jury's out on whether or not 5-ARIs, preoperatively reduces blood loss. People do it. And the papers are about 50-50 in terms of an impact or not, but I haven't noticed it with steam.

Dr. Amy Krambeck:

One question that came in from the group is do medications like tadalafil improve postoperative results?

Dr. Kevin McVary:

I can't comment on that. I don't know. I usually keep those medications on for about six weeks. And then taper off. The reason I do that is there was a trial looking at microwave versus medical therapy and the lines crossed at six weeks. So I said, "Well, okay. It looks like six weeks is the magic time." And since I don't have a better timeframe, I just hypothesize that if it worked that way for microwave, it's going to work that way for steam. So, usually it's about six weeks and I taper them off.

Dr. Amy Krambeck:

Another question that came through is, is there a tissue sloughing and do the patients get bad dysuria with that?

Dr. Kevin McVary:

It can, particularly if that steam vents off to the side as I mentioned, then you can slough. And patients will call and say, "Hey, some gray stuff came out." I've had some of that slough block where the patient say, "I was peeing just great." And then one day click and you scope them and there's like a slough flop. Grab it with a grasper, pop it, you'll be fine.

Dr. Amy Krambeck:

And then how long does the dysuria last?

Dr. Kevin McVary:

Well, in the best cases, around two weeks. Those men with OAB, longer. With preoperative known overactivity, it tends to be longer. Symptomatic.

Dr. Amy Krambeck:

We see that quite a bit with laser therapy too. We give anti-inflammatories, do you give anything like that to help or-

Dr. Kevin McVary:

Yeah, I do, but I wonder if I'm treating myself.

Dr. Amy Krambeck:

Yeah.

Dr. Kevin McVary:

I'm treating my nurses.

Dr. Amy Krambeck:

Very true.

Dr. Ulrich Witzsch:

What is your [inaudible 00:40:48] for antibiotic prophylaxis? We had two patients who have a severe [inaudible 00:40:53].

Dr. Kevin McVary:

Well, I wouldn't actively treat in the face of a ... I mean, I wouldn't treat in the face of an active infection and I just wouldn't do that. But since you asked, if you're doing a beer block, a transrectal beer block, then I would give them what antibiotics you're doing for a prostate biopsy because you're going transrectal. I don't do anything other than that, except on the day of decaf, I give them one antibiotic pill depending. And just on the day of decaf. I don't give them antibiotics for the interim, the intervening period.

Dr. Ulrich Witzsch:

There was another question coming up. How about chronic prostatitis and Rezum?

Dr. Kevin McVary:

No. Run away. I would not advise doing this, what I would call chronic pelvic pain syndrome. This is not a treatment for that. Anecdotally, I think those patients do worse. So, stay away. It's for obstruction, not pain.

Dr. Amy Krambeck:

Do you find that patients who have a large median lobe have more morbidity or take longer to recover than patients [inaudible 00:42:14]?

Dr. Kevin McVary:

No. You can't separate them. In fact, in some ways, those that have middle lobes, their scores might be a little bit better. So it's game on with the middle low. You see it, go get it. They'll do worse if you don't get it

Dr. Amy Krambeck:

Dr Witzsch, do you have any more questions?

Dr. Ulrich Witzsch:

Well, how about changes of the ejaculate? We had some patients who were concerned, not about loss of the ejaculation function but of the change of the ejaculate. Can you comment on that?

Dr. Kevin McVary:

Well, I mean, patients will say that there's ... Some will say, "Hey, there's a difference." And that's why I say it's not 100%. Again, that goes back to the imprecise nature of the tool with this large standard deviations. But on balance, most patients say, "Hey, I'm back on game." So [inaudible 00:43:09] the game. Most. Vast majority.

Dr. Amy Krambeck:

So if someone is interested in doing Rezum, how would they get involved, how many cases do they need to do or watch to start?

Dr. Kevin McVary:

So, my advice is pick your cases on modest glands, not small, but not big, not urinary retention, not lots of co-morbidities, guys where you're going to win. And do them in the ASC, do them with them sedated. Have a mentor, have a peer, watch. The reps from the company are very knowledgeable. And so you can talk during the case and say, "This is how it works." And I would do that maybe the first five or 10 cases. You won't need it after that. It's so simple, even a urologist can do it.

Dr. Amy Krambeck:

That's exactly what we need.

Dr. Kevin McVary:

Yay.

Dr. Ulrich Witzsch:

You think the learning curve is 10 procedures, right?

Dr. Kevin McVary:

It's less than that.

Dr. Ulrich Witzsch:

Less than that. But, do you think we really need this extensive training which is recommended by the company?

Dr. Kevin McVary:

Never say no to education. Come on, man. This is the game we're in. No. I'm better now than I was three years ago or five years ago during the trial. No question about it. So there is always this learning. The idea is, are you competent, are patients going to improve as you treat them? And you don't need a lot of patients to get that. It's intrinsic to our urologic nature.

Dr. Amy Krambeck:

With the procedure, it looks like there's not a lot of bleeding at all. Have you ever gotten into a situation where you did get into bleeding and had to use a resectoscope loop or a roller ball?

Dr. Kevin McVary:

Never. I've had bleeding. One time, I couldn't really see, I put in a resectoscope, washed them out, pulled it out, put in the standard scope and finished the case. Sometimes even steaming will control some of that.

Dr. Amy Krambeck:

So there's no reason for someone to pull a resectoscope loop and have it in the back table.

Dr. Kevin McVary:

No way. No. Never had to do that.

Dr. Amy Krambeck:

Perfect. So Boston Scientific supports this technology and that's who they should contact if they're interested in-

Dr. Kevin McVary:

Yes. Been very supportive from the people I've heard. I learned during the pivotal trial obviously, but my colleagues who weren't with me told me that support's been good.

Dr. Amy Krambeck:

What about bladder neck contracture rates, are there any reported bladder neck contractures? It seems like you're well away from the bladder neck.

Dr. Kevin McVary:

Yeah. They should be low. I suppose if you misdirect it, you can do it, but I'm not aware of reports. Put it that way.

Dr. Amy Krambeck:

Okay. And then where do you think this fits in comparison to the other technologies we have like Aquablation, microwave, UroLift, Rezum, how does that fit in a urologist armamentarium?

Dr. Kevin McVary:

Well, I look at it is urologist has to have a MIST in his holster. And I don't think he has to do all the MIST. I think you need one MIST. I like this one because it's versatile. The anatomy, I can handle. It doesn't make Lift wrong, this I feel is a little bit more versatile and the durability is certainly encouraging. Aquablation is not a MIST. That is a general anesthesia, that's a giga invention, not a mini. So I don't think they really compete on the same scale. Whether or not Aquablation is going to have a long term role, I think time's going to tell us. But TUNA is on the way out. It's actually not endorsed by the AUA guidelines and microwaves in the ICU.

Dr. Amy Krambeck:

So this definitely replaces those two therapies-

Dr. Kevin McVary:

Yeah. I haven't done those in more than 10 years.

Dr. Amy Krambeck:

And then I know you presented on how to do a median lobe, but the question came back through again on how you would do a large median lobe projected in the bladder. So can you just recap that?

Dr. Kevin McVary:

Yeah. So two laterals from lateral to medial. And if it's really big, then go up on the gland itself, presumably you know how thick it is. It's not going to be a skinny one, but a nice bulky one, one in the middle. I've only done that a few times.

Dr. Amy Krambeck:

So you wouldn't do two extra treatments if it's very large, you just do the three, the sides and one in the middle?

Dr. Kevin McVary:

Well, for a median bar, it's one treatment from an oblique treatment. For a middle lobe, after you've finished your lateral treatments, position the scope at the cleft, pull back a safe distance, bum bum one on each side. If it's very large, you can do a third in the middle. And again, it's unusual.

Dr. Amy Krambeck:

Okay. Another question that came in is, if a patient is without a fully catheter and has Rezum and then failed to wean off the catheter at a week, what could have gone wrong?

Dr. Kevin McVary:

Well, he could have diagnosis wrong. He could have just lots of Edema. So, try it again. Not the treatment, another trial without catheter. Give him another week or so.

Dr. Amy Krambeck:

Would you transition them to self catheterization?

Dr. Kevin McVary:

It's never wrong. If you can get them to do it, that's the best. I love the intermittent catheterization. They'll tell you when they're ready to decathe

Dr. Ulrich Witzsch:

Professionally, also on the [inaudible 00:49:02] prostate, sometimes it's really weeks until they work properly.

Dr. Kevin McVary:

Yeah.

Dr. Ulrich Witzsch:

So that's why we like the suprapubic catheter.

Dr. Kevin McVary:

Not done that here. Not common in the US to do that. I understand the reason, but it's just not common.

Dr. Amy Krambeck:

Dr. Witzsch, how would you use that suprapubic catheter, would you have them clamp it and then uncap if they can't void or how would you do that?

Dr. Ulrich Witzsch:

Well, the patient's through the residual volume and if it's less than 50, the suprapubic will cost hours. And sometimes it needs six, seven, eight weeks, but especially in big prostates, bigger than 100 gram.

Dr. Amy Krambeck:

So we're down to the last three minutes. Dr. McVary do you have any take home points that you would like to make at this time?

Dr. Kevin McVary:

I would just say, hey, think about a MIST in your practice, do it under a controlled circumstance when you train, before you transition it to your office. And get comfortable with it in an ambulatory setting, sedated, then you can transition. And that's just five to 10 cases, you're ready to go.

Dr. Amy Krambeck:

Perfect. And Dr. Witzsch, do you have any closing comments?

Dr. Ulrich Witzsch:

If you're interested, get in contact. It's an option for patients [inaudible 00:50:22] catheter but you have stick to the procedure.

Dr. Amy Krambeck:

Your comments were wonderful. And I think the presentation by Dr. McVary was great. So I just want to remind everyone that on October 9th, we have robotic urinary diversion with ileal conduit and neobladder. The surgeon is John Sfakianos and Alvin Goh. And the moderators are Andrew Wagner and Prokar Das Gupta. We encourage everyone who is not already a member of the Endo Society to join. You have multiple benefits, which includes full text online access to the Journal of Endourology, Videourology and Journal of Endourology Case Reports. And you can go to the endourology website for more details.

Dr. Amy Krambeck:

And then finally, I would like to remind everyone to save the date for the World Congress of Endourology in 2021. We are planning to have the meeting in Hamburg, Germany, September 21st through 25th. Thank you all for attending and I appreciate your attention.