Join Steve Sterious, MD FACS from the Fox Chase Cancer Center at Temple Health to discuss Aquablation and the changing surgical landscape of BPH.
dr steve stories. I'm coming from Fox Chase Cancer Center to talk to you about aqua ablation, this new type of surgery for the prostate. It's changing the surgical landscape of BPH. And so I have been one of the surgeons in pennsylvania that does this and I wanted to talk to you about my experience and the clinical outcomes. So disclosures. I am a consultant for processed by robotics, which is the company Bph is the number one reason for visits of men to urologists. Um you know, it basically almost 40 million men have some kind of bph pathology. It's a $4 billion dollar industry with lots of lots of costs anywhere from medications to surgeries. The patient is showing up to the to the You're all just with questions of problem with urinating. You can see here from this there are a bunch of patients not managed have bph and just kind of are afraid of surgery or medications. About 300,000 surgeries per year, you know, are performed. And about four million patients are on watchful waiting, meaning they have symptoms but they really don't really want to proceed with surgery or medications because of side effects. And so Uh major impact on quality of life. You know, men get up at least one or two times per night. Uh you know, 92% of men um you know have this problem. Almost everybody thinks it's cancer. Um You know, and over half of men really are concerned about surgery complications. And so that's why they do not proceed with any kind of surgical intervention and try homeopathic methods or stick with just medicines even though the medicines may have some side effects, they can help them a little bit. So standardizing Bph surgical therapy with aqua ablation is a procedure that can kind of you know run the gamut of of size of the process. Is the process supposed to be like a walnut and it can go all the way up to about uh you know, extra large, you know, tennis ball. You know I I say sometimes it's like a cantaloupe in some patients. So there's office based procedures, your lift resume, which we do here at Fox Chase. Um There's hospital based procedures. Terp green light hole up simple raw robotic prostatectomy. All of these we do here at Fox Chase and then you know aqua ablation is basically you know, size independent is because the robot will explain a little later. But the robot can basically handle any size prostate and respected with the water jet. This is the system here. Um And basically each patient gets a gets a reception based on their anatomy. So it's somewhat of uh you know, precision medicine, somewhat of personalized medicine because I I explain to patients that the prostate is kind of like a fingerprint. And so everybody is a little different. And so you should get a surgery that that that recognizes that and brings that into consideration when when you're doing the section. So just a cartoon of of the procedure. The here you can see there's a probe in the rectum over here is where the ultrasound is kind of attached to the patient here. They're attaching the systems go to the bed. And so everything is in place to kind of map out. So this is the prostate. And this is kind of this is basically you map out what the robot does and then it will respect the prostate based upon what you say. And and also you can adjust this in real time. So once you do the planning, it's not like it's set in stone. You can adjust you know before you even start. You can adjust while you're doing it. So it is it is not static. It's very flexible. Uh And basically you can change you know from from second to second from minute to minute. And so what you do is you you set this, excuse me. You set this plan up and then you start the robot and it will respect. Now this is the cartoon version here. And then this is kind of the real life version. And so it goes back and forth and sweeps back and forth and and destroys the prostate here. You can see kind of the real life version of it destroying kind of prostate tissue. And you see this kind of white fluffy tissue and we'll get into that a little later as to you know what that looks like an ultrasound. And what that means. You know for the patient, here's some pictures before and after. You know there's just a topic pictures. It's nice. There's um like ultrasound pictures that you know kind of show you what the prostate looks like afterwards. So this all started back in 2015 to 17 with these studies to get FDA approved. So this is all the studies we're gonna go over the studies that got at FDA approved. They now have five year data out. So this is this data is old and has been replicated up to five years. So they started the water study the water one study was basically prostates 30 to 80 g. Uh And basically they wanted to compare it to Terp. Terp is a gold standard uh surgery for Bph. And so if you can prove that, you know, occupation is non inferior to Terp then and it's basically has a superior efficacy uh superiority. Then basically you could prove that occupation. You know uh the approval and should be uh in the marketplace for Bph surgery. And so they basically randomized. It was basically 2 to 1. Aqua ablation versus terp. And so if you look here, this is kind of three month safety, looking at Cleveland indo uh complications which can be anywhere from ejaculate dysfunction, erectile dysfunction continents U. T. I. S. And you can see here um you know blue is is aqua ablation and is. And if you can see here if you look at one and two um When you combine them. You know basically aqua ablation does better for the for the to one occupation. Did much better for the two. It was not really significant. Talk about Bph. You wanna check my P. S. S. Uh you know scores that's how bother patients are. And you can see here the line up to two years which is what the the I. P. S. S. Drop is consistent over two years for turbo as well as occupation. Which is basically showing that operation is similar to interpreting treatment rates. It's always important. Are we doing a procedure that maybe is gonna need to uh be done again in in a year or two? And so it was not statistically significant. And the five year data show that occupation treatment rates over five years is about similar to this. There's just more data showing um the quality of life actually showing Q. Max how how strong the stream is. PBR all of these were not statistically significant when compared to Turks which was good news for aqua ablation because it basically showed that it was equivalent to two terp Now where where it actually did better patients are concerned about ejaculation. And so when you perform a terp the risk for ejaculate or dysfunction can range anywhere from 50 to 60 6%. So that's a huge difference. And this can be shown here with this uh M. S. H. Q. Ejecta Torrey Dysfunction uh survey showing that two years out. Aqua ablation did not really affect much as terp did. So the conclusions for the water one study were lower rate of sexual dysfunction, reduced dependency of resection time on the operator and we'll talk about that a little bit basically prostates that were 30 versus 80. They'll take about the same because the robot is doing the resection. There's really no an atomic restrictions max your I. Ps. S. Re treatment rates. Those are all similar to Turkey. Now they did a specific subgroup analysis of greater than 50 grand prostates to 80 grand prostates showing that occupation seem to be a little superior and it kind of makes sense. The larger prostates are more complicated to respect from a terp standpoint. And so if you have a robot that standardizes the resection you might get a better reception. And so you can see here um the safety endpoint and the fc endpoint were superior. And so because of the subgroup analysis they came up with the idea to study aqua ablation in larger prostates 8200 and 50 g. Now they weren't able to do a control arm in this study just because there's no real control arm. Endoscopic control arm. Uh Just because you don't really do a terp in a 82 150 g prostate. They didn't compare it to hole up or robotic simple. Which is what would be somewhat comparable. So they basically just did 100 patients and and wanted to see what were the outcomes. And the conclusion was. Aqua ablation therapy is effective, you know, enlarged prostates. Here's some demographic data, you can see the prostate volume average of 107 intra vehicle, you know median lobes. Um You know a lot of them have medium lobes and uh you know it was it's it's a pretty good range of sizes. Um And clinical outcomes. Now the homeostasis is what kind of was the big kind of drawback for occupation because you don't use any heat. It's a it's a heat free resection. And so in the beginning I was doing this too, I use this this is the catheter tension device in the beginning you just use a lot of uh tension on the catheter to stop the bleeding. And so for the for the water to study the rates of the rates of blood transfusion was was close to 8 to 9% because there was no heat used in the water. One study the rate was a little lower 5 to 6%. Um They used a little heat but they didn't use a lot. And so um aqua ablation had this kind of stigma that bleeding was the issue. Um Now if you look here um this is kind of data from the water to study. I'm just looking at this graph here shows you the I. P. S. S. After 12 months basically looks the drop is consistent if you look over here. This is basically um looking at because there was no control arm just looking at what our clothing window. Uh Two and above for other trials. You know this is a terp trial. This is a green light trial uh with aqua ablation being in the blue and uh that is the Cleveland indo classification. So basically if you look here aqua ablation, prostate size 107 the Nintendo uh complications is about 35% aqua ablation. The water one study 54 is about 20%. Uh This terp trial uh average size of the prostate was about 51 is about 23 percent complication rate. So you can see for these larger prostates for these smaller prostates compared to the larger prostates and water to the Clavin. Dental complications were pretty similar. So it was kind of an exciting time to show that you can respect these larger prostates and not have as many complications as people would expect. Again this is just kind of more data. Looking at the I. P. S. S. And change in I. P. S. S. Um for To study over a two year period X. PVR changing PVR changing connects all these kind of just show that it is uh and drop in the PVR a sustained drop in the Q. Max. So this is out two years for this study but you know out four years now is for water to studies out about four years now. The thing about occupation is you know it's predictable. So you go into the O. R. You set up the reception and the robot does the section. And so if it's 100 grand prostate, 200 grand prostate the difference in reception time is very minimal. If you were compared to um you know, green lighter terp as the process get larger. These other resection resection techniques take longer. You know there's more tissue there but to go from a 50 grand prostate to 150 grand prostate for aqua ablation that you add maybe a minute or two for the reception. So that's that's exciting that you can do kind of varied size prostates in about the same amount of time. Um The water to you know, conclusion was basically you have a sustained reduction in an I. P. S. S acceptable complication rate when compared to other trials. Um No an atomic restrictions. You know and durable results out to two years now out. You know, we can see about 2 to 4 years to basically showed that occupation therapy you know is great. There's no an atomic variation that they can't do consistent durable outcomes. The benefits include um you know consistent our time's short resection time. You know and maintenance of and a great ejaculation patients are are concerned about and so um we'll look at some data to show. But basically you know, it's about 6 to 8% chance that you're going to get some kind of an a grade uh you know risk of remove. Uh So because of these studies that were done in it was part it started to become part of the lines uh A. U. A. The Canadian um you know in europe. And so these guidelines have been updated um and probably when they do another update um occupation will be kind of approved for larger prostates. It's not in here, but people do it in larger prostates. I do it in larger prostates and it is terrible as the water to studies showed. But for when these guidelines were reviewed really the water one study had the most durable results. And I see here this is the au a guidelines updated 2021 showing op ablation um is recommended for process 30-8 g. Now again, he mistakes is the issue. We talked about it. You know, kind of earlier transfusion rates have have dropped and that's what we're gonna get into how that happened because you need to use focal bladder, neck Kateri uh and some catheter attention. But it has to be the right catholic attention. So This was a study done early 2021 that basically looked at, you know, 800 operations and looked at the different techniques for controlling the bleeding. And so there was a standard attraction and a robust attraction I used to use the robust traction. But what this study showed that basically the robust traction probably caused more um more pain and probably cause more bleeding. Um when you compare, you know, kind of size of the prostate. Not a big, Big surprise, but larger prostates seem to have blood more. So if you look, you know, comparing these 800 occupations, the larger the size of the prostate, the more chance that you could get a blood transfusion. The P value was zero. And if you look here, it looked like robust traction was another significant finding which they basically show here. If you look for different sized prostates, the this is robust traction, kind of in this light green grayish and this is really kind of standard traction and you're, you know, you're basically risk of having transfusions, you know, significantly the prostate gets larger. You use robust traction, significantly goes up. And so basically this study just kind of showed using that catheter attention device trying to pull really hard in the project to stop the bleeding. Cause more plain cause the higher blood pressure is what they think and probably caused more bleeding. So, the conclusion for this study was, you know, basically just use uh you know, regular uh attention and use the bladder neck artery. That was part of the study as well, looking at bladder neck artery with regular standard tension. So this is just a comparison kind of looking at, you know, uh one study basically uh you know hold up open civil prostatectomy In light that green light in larger prostates. And you can kind of see here you know the transfusion rate 6% for water to you know for open simple prostatectomy 24%. You know all of this is in pretty much line with for larger prostates. Um these older studies to show the transfusion rate is pretty similar to occupation. So basically the reputation that occupation had was there's a bleeding problem. But when you look at other studies, I mean it wasn't it's They did another study you know very recently just kind of looking at over 2000 operations and using you know kind of this standard standard traction as well as bladder neck folk watery you can reduce the risk of transfusions under 1%. And so this kind of put the bed that there is a problem with aqua ablation. Follow this protocol. You know, your risk for you know transfusions is under 1%. And if you kind of look back at that previous slide, you know under 1% is really good compared to those older studies. Um Now let's talk a little bit about kind of sexual function and ejaculation which is very concerning for some patients. Um This is a study in early early 2021 that basically showed you kind of look back at the water one water two studies and basically wanted to find what's the risk for ejaculate Torrey dysfunction after occupation like what can they find for the patients that had uh population, What did they have in their planning? And basically the conclusions you know from the study basically looked at, you know when you do the, when you do the planning you need to make sure this this is kind of the viewer sparing zone. It's a butterfly cut. It's a little hard to kind of visualize. But basically the posterior prostate is not respected. And so if you section in this area, you know the death so death below the zero penetration of the ejector ducks. It showed that patients had better ejaculation, better function. You didn't damage the tissue near the ejector ducks or damaged trajectory ducts. You had a better a better outcome for ejaculation. And so this was you know, if you have a patient that's very concerned about it, you need to be very careful in your planning here and just realize you know, be very conservative with the reception. I just want to show you a little bit of my experience. I've done about 100 but I just want to show you my 1st 30. You can kind of see here here's the prostate sizes down here. You know close to 200. I've done up to 300 the procedure times. And so you can see here um it's it's really uh you know, not that uh you know really not that much big of a difference for the 1st 30. And then you can kind of see here the average, you know, the average prostate was about 70 CCs for my 1st 30. And the average time is about 41 minutes. You guys hear the learning curve, you know, as the as the numbers went up as I kind of became more adjusted and more comfortable with the technology and the and the surgery, the procedure times, you can see kind of go down. So it's it's the learning curve is fairly easy and then you can compare my real world experience with the water one study and you can kind of see here about a year. The I. P. S. S improvement is very similar. My sample size was 21 at this time, the the bigger the procedure times a little longer, but again pretty equivalent. So it's it's it's good to have real world experience that replicates. Uh So I, in 2020 I submitted an abstract kind of looking at at, you know, what were my bleeding complications. Um I did kind of water to did was no Kateri kind of robust traction and bed rest. And so when this came out I really didn't have the information from those newer studies showing robust traction, you know, is not really good. You don't really wanna do robust traction to cause more bleeding. I basically just replicated the water to studies showing if you do you know, no, no Kateri robust traction, you'll get a transfusion rate around 8 to 9% and that's and that's what I got and you know the operative times not bad under an hour, you know for for you know these 1st 30 to 40 patients. And and here when you look at kind of our experience, you know, basically compared to the water to hear, you know this was about 9%. Transfusion rate was about 9%. You look at the water one uh prostates and they did use a little heat. So the less transfusion rate um you know these are all kind of in line with uh you know older studies and so uh you know the outcome now stand attraction um as well as focal bladder neck artery. Another study that I wanted to look at my outcomes to kind of help post patients post operatively. Uh and you can kind of see here, you know for kind of medium sized glands, what we're kind of the complications do they compare you know to do they compare to kind of older studies and you can kind of see here transfusion rates uh kind of for more recent studies, you know for terp for 7 to 3%. You know my transfusion rate, you know was about 4% for these mid sized glands. So really you know on par with what the kind of more recent and you can kind of see here the prostate sizes larger glands. Looking at you know what are um you know this study was basically looking at robotics simple prostatectomy versus open simple prostate check basically you can look at complications. You can look at you know and pretty much pretty similar between um Larger prostates. Transfusion was about you know 8%. And so you know that's that's that's pretty on par with what you know what these studies show. So occupation large prostates is doable and it is pretty similar to robotics. Simple as well as open simple um that my E. D. Visits and my kind of readmissions and I found that when you have a larger prostate you probably want to leave the catheter in a little longer. I was taking catheters out very quickly and you know patients were representing with a lot of attention your attention and so I can have a protocol now any patient over we'll keep the catholic for a couple of days let the prostate um You know kind of cool off and stop you know the oozing and and the bleeding. So I wanted to talk to you about some studies some procedures that I did kind of early on and just I'm gonna show you some videos and uh you know it's it's basically what you know these these kind of initial uh cases you know I saw the outcomes of them and it really made me buy into this technology so it's a 64 year old guy. You know he's got an elevated P. S. A. His biopsies have been negative. He's had some E. D. And he's got a very large prostate and does not really like Flomax failed it. A symptom score is 14 and he's bothered by symptoms and he's worried about the RDS E. D. He's worried about ejaculation and E. D. Problems. And so here you can see me measuring the prostate. This looks like a fairly large prostate. Um uh you know I'm gonna do the calculation. You won't really see the calculation you know on the screen but this is me measuring out and you can just kind of tell when you look at this satchel view it's a very long prostate. Uh And basically you know it's it was measured preoperative 1 80 I think. Inter operatively I measured it at 1 60 or 1 70. Here's the scope coming in. And so um the scope is seven centimeters. You know long. And so you can see here you know the scope almost spans the whole length of the prostate. So seven centimeter prostate. It's a very big prostate. So you can see here this is the scope coming back. What I do is I place the scope just in front of the sphincter so that you don't have to worry about incontinence or damage of the sphincter. And here is the planning phase. So this is how deep the jet's gonna go. This is how wide it's gonna go. And you can see that it's gonna basically, you know, expand the whole length and size of the prostate. And so once once you make the assessment in the transverse plane, you kind of make it in the sagittal plane to show where how, how deep you wanted to go and what you want to spare. If you remember back to that That study back in early of January 2021, this this is the area that you want to uh you know, preserve for patients that are concerned about ejaculation. The Ducks are here, the Vera Montana's here. And so you'll see me kind of raise this red arrow and this is this is where you can preserve that, that tissue and that preserves erections and preserves ejaculation. You can see here this is 100 and 80 g gland about. It's gonna take five minutes 32 seconds to respect. Like that's, you know, that's that's ridiculously short time. Um If this in the er with a robot, it could take up to three hours with the setup and everything. Again, there is a set up here. But the reception time is about five, you know, five total time to do this is about an hour. And so you can see here that the, you can see here, I kind of adjust it a little bit on the fly uh saying I didn't like how deep it was going. So you can, you can adjust as it's respecting uh, and you can adjust before it respects. So it's a, it's a very, you know, easy to use technology. Um, and then after you're done, you come in and at this point I was not using the focal bladder neck Kateri, I was just kind of irrigating out of all this tissue and putting people on contraction, which, you know, worked out. And you can see here, I mean, in about a couple of seconds you're gonna see how wide open, you know, this channel is, which is, you know, which is amazing what it went to, what it started at what it comes to. So here's the catheter coming in and putting it on tension. This is a second case. I just want to talk to you about a 60 year old guy. You know, he, you know, has some pest magical history. He's never had a surgery. He's got a large prostate and he can't be, he's catheter dependent and he hasn't been able to pee for several months. And so he's failed medications and he has very bothersome symptoms for he was on these medications was bothered and then eventually could not pee anymore. So you can see this prostate looks much different than the other one. The other one was extremely long and this one is kind of like poking into the bladder. And so that's where this technology, you know, really shines because you can, you know, it doesn't matter what the prostate looks like. You can respect it based, you know, based on, you know what it looks like and adjust your planning. So if you look here, you know, I've got to adjust to this. Like I didn't have to adjust much in the other prostate because it was long and why this was a little more narrow and it has, you know, a median lobe component. And so the technology has this, you know, you can adjust and and and basically respect the median lobe which put into the bladder and you can adjust to the, you know, basically I can adjust this jet to go way high. This is the bladder. So this is, you know, basically fluid and urine. So you're not gonna hurt the bladder wall out here. You're gonna just respect that tissue. And you can see here, I didn't show you the reception. But you know, that looks a lot different than the pre the pre op. And here is a system topic view. I just wanted to show you the system topic view kind of this is what it looks like before you respect. There's all this tissue, uh, you know, right there is the sphincter. So I move the scope just in front of the sphincter. And so basically you're the jet will never get to the sphincter because I'm blocking it. You can kind of see here this is that fluffy tissue that will all slough off with time. But you can see here now, you can see this dark is the bladder and you have a open channel, you know, right to the bladder. And honestly there's there's really not that much fleeting here for this era where I did not use the electric hollering, I was basically just irrigating and using traction and you know, not not horrible. Uh not a horrible amount of bleeding. This is the third case I'm gonna talk to you about. Um And so young guy 54 is about 100 g planned and Q max extremely low. You know, you should be 20 to 25 at seven and he's sexually active. He's young, he's very concerned about it. He's very concerned about ejaculation. The total procedure time. You know, this one went quick. This was kind of at the end of my 30 cases, probably maybe my 40th case or something like that. So I know how to adjust all the equipment, get to get the scopes and get them out and so 37 minutes, you know, that's that's really quick for this large of a gland and so here um you kinda can see here, this is, you know, me kind of measuring out and adjusting what's the planning stage, How far is the, is the reception, you know, gonna go how deep, how wide and so if if you don't like if you think it's going too deep, you can adjust it if you think it's going too wide, it's gonna go outside the capsule. You know, you can adjust it. And so that's what makes aqua ablation such a great procedure because it it adapts to what the anatomy of the prostate is. It's not the one size, you know, kind of, you know, it's all patient because you can adjust it. Now here over over here you can see um Now I'm doing the planning in this agile. And you can see here this is you know, kind of your first where you start the resection bladder, neck, kind of mid prostate. And then up here this is where the view and all the directory ducks are. This is where you kind of want to save. Um You know, this guy was very concerned about ejaculation. So this zone here is going to be, I want to preserve that. You know, I'm gonna basically make sure that the jet does not come down here to respect this tissue. So I'm trying to preserve all this tissue here. Then you see me making this, make sure it's wide enough. So again The reception, you know, five minutes. It's obviously sped up. But this is, you know, kind of real world. Um and you can see it destroying the tissue and just opening up this channel. Um you know, another the other aspect to this. If you feel like after one pass, I didn't get enough tissue right here. You can do another pass. It takes literally 345 minutes. And there was actually a study that just came out recently. Um That showed two passes are better than one. You know if you do two passes it gets rid of more tissue and patients better clinical outcomes. And so um I've been doing a lot of most of my patients, I do two passes just because I feel um you know, let's do two. Let's get a little more of the tissue out. Um You know, it doesn't add much time to the surgery and I think, you know, and the research showed that you know, it actually doesn't patients do better. Um But you can kind of see here, you know, you know like well what's all this tissue here? This is all that kind of fluffy tissue and blood clot. And so um you know a lot of this is not prostate tissue anymore. Um This is the second pass here. So you kind of see here um You know, I really didn't like how deep it was going. So I made the power less so again you can adjust in real time and then once you start hitting kind of tissue again you can say well now I wanted to go stronger so it's it's uh you know, you can adjust your treatment. You know, it's it's just a very unique and versatile technology. Quick procedure at a year follow up cause I. P. S. S dropped to two. It was 22. He's really bothered. He's doing great. Is Q. Max is now 21 from seven, you know, tripled and he still has ejaculation. So he's extremely happy and excited. He did not sacrifice his yakitori dysfunction or function for you know surgery because his urination is so bad. So patients love that. They don't have to, you know, it's not either or they can have both. They can have their ejecta torrey function. They can have better urinary function and and have limited side effects. So in conclusion, you know, this is equivalent to terp, you know the water one study showed that it's safe unification and larger prostates. That's the water to study um size independent technology. You know, lower sexual side effects. Transfusions are comparable to other modalities especially now with the new the new techniques, normal traction not robust as well as black folk record. Uh And it's easy to learn. You can see that from my 1st 30 here are my references and so some people, you know have called me kind of the walter white of the prostate. I did enjoy this. And if you have any questions you can, you know, you can reach out to me
