Herbal remedies for swelling of the prostate

all right. thank you very much for the invitation.i'm excited to speak about the role of robotics in prostate artery embolization. so a coupleof things i'm going to cover here. first, is just review the literature for pae anddescribe a little bit about who's the candidate for the procedure, then focus on what thechallenges are with the procedure, because think that's the main obstacle that we facewith pae. and then, the transition of the magellan robot into our current practice withpae, and then what those actual advantages are over the traditional method. and i'llshow some case examples. so in terms of who is the candidate, there'sreally a few ways to break this down. the first is looking at what does the data supportin terms of which patients to treat, who are

poor traditionally urologic candidates, andlet's talk about who's not really a candidate at all for pae. so the data, when we lookat a review article from 2014, this is published in cbir, and it reviewed all the studies doneup until mid last year. and as you'll see on the next slide, it looked at 562 studiesthrough a pubmed database study. they ended up narrowing it down to nine articles, inwhich they reviewed 706 patients that were actually included in the analysis. there was some possible overlap of data fromeuropean studies, and there were no randomized control trials at that point published orstudied longer than two years. all patients had moderate-to-severe symptoms in terms oftheir prostate enlargement, or bph, and the

mean age of the patient in these studies is,as you would expect, in the mid to late 60s to early 70s. when they took all the datatogether and they pulled it all together, they found out that although these patientsstarted in the moderate-to-severe category, as you can see here in the dark blue line,this is an ipss score, which is the severity of symptoms a man faces from their prostateenlargement. and you can see that it reduced by more than50% in the first month after the procedure, or pae, and was durable to at least 12 monthsand then out to 36 months. their quality of life, which is on a different scale of 0 to6, did also improve by 50% or more. and this is also durable out to 36 months. so besidesthis really impressive clinical improvement,

they also found that there was a decreasein prostate volume, psa decreased, and importantly, there was no deterioration in sexual function.and they concluded that the overall benefit of pae is very positive at 12 months and theprocedure does seem safe. now, subsequent to this, there were two randomized controltrials that were published and presented at a national meeting. the first of this studythat was published in radiology, it was a chinese study. it was a randomized control study with upto 114 patients, in which half of the patients were randomized to get turp, which is thetraditional transurethral resection of the prostate, or a roto-rooter type procedure.in this procedure, which is performed through

the urethra, as most people may know, is associatedwith a significant complication rate anywhere from 5 to 15%, in terms of things like incontinence,impotence, bleeding, etcetera. and other complications, such retrograde ejaculation occur in up to75% of patients. in this study, they wanted to randomize patients to turp or pae, andthey looked at mid-sized prostate patients which are 50 to 80 grams in size, and theyfollowed them for two years. and what they found is both sets of patientshave significant improvement in symptoms that did not differ. the pae group, however, didhave twice the failure rate compared to turp. and that's important because that differencein failure rate was really related to the technical success of the procedure, whichspeaks to the challenge. carnevale presented

his data from brazil at the 2014 americanurologic association meeting in which they did 15 patients in each arm when they comparedturp and pae. and they found also both arms demonstrated significant improvement, althoughthere were less complications with pae. there was a better improvement in terms ofquality of life and flow rates associated with the turp arm compared with pae. and you'llsee here that in the gao study, both red and blue, pae and turp, from 0 months to two yearson both left and right. left is the clinical score of ipss, how do people do. and you cansee they both have significant clinical improvement and there's no difference at 24 months. andin their study, there was no difference in flow rates, as you can see on the right, attwo years. in the carnevale study, you'll

see that they both improved in terms of symptomimprovement, however, there was a greater symptom improvement in the turp arm comparedwith pae. now, in the subsequent slide, you'll see thatthe flow rate did improve greater in the turp arm than the pae group, although the pae groupdid return to a normalized flow rate, which is about 50 ccs per second in an adult male.so further, other studies have also demonstrated improved quality of life - and i won't reallytouch much on this. but quality of life study that was published by carnevale also demonstratedthat in patients who are catheter dependent, in 90% of patients, you were able to removetheir catheter in patients who had bph and complete bladder outlet obstruction.

they did have one complication, and that alsospeaks to the technical challenge of the procedure, and that was an area of bladder ischemia inwhich the catheter was probably placed in an area where the embolic material was thendelivered into the testicle or injured vesicle artery going to the bladder. so are therelimitations to other therapies and give us opportunities with pae? well, with large glands,as you can see here on the left or on the central area, a small prostate or with a bigmedian lobe on the right, there are different complications associated with those procedures.and those complications are things that limit the ability of traditional procedures liketurp, micro wave laser, and allow pae to come to the forefront as a relatively low riskprocedure, however technically challenging

to perform. so for pae, does size really matter? and you'llsee here on the left with a large prostatic artery, here in the middle with an averagesize, and on the right with a small prostatic artery. ironically, the large prostatic arteryon the left has the most tortuous course. so even though it may accommodate a cathetereasiest in terms of its size, the tortuosity does limit the ability for the interventionistto actually catheterize and secure it [inaudible 00:05:59] for a position for embolization.so there are technical challenges with each size, but in terms of clinically, as you'llsee here on the next slide, whether it's a large volume prostate as you'll see here onthe left or in the center, when there's midsized

prostates. or as we presented recently hereat isat, in florida, dr. katzen [inaudible 00:06:16] on the right, a small-sized prostate,mid-sized prostate, and large prostates all do the same. they all demonstrated significant clinicalimprovement, and we also presented this data at the sri meeting just last month. so arethere challenges with pae and why is this not so widely adopted? i just mentioned earlierhow tortuous the arteries can be to navigate, and i think that's really one of the mostprimary challenges of the procedure. the anatomy in elderly men does distort and misdirectpre-shaped catheters, or as we call pre-robotic catheters. there are small distal target arterieswhich require proximal support, which sometimes

proximal catheters like 5 french catheterscannot offer. acutely angled origins, which i'll get into,the origin of prostatic artery is often acutely angled. then there's some issues with actuallyrecognizing what is the correct prostatic artery. and then, the last is a safety issue.the cases can take a long time if they're not consistent and performed in a reproduciblemanner, and this can lead to high radiation doses not just to the operator but to thepatient alike. so is there really a role for robotics at all? i'll get into this here witha few examples in what those challenges are. so in terms of limitations here, you can seehere on the left. this is a fairly straightforward ipsilateral iliac artery selection, in whichwe used a reverse curve catheter, like a [inaudible

00:07:31] catheter to do our selection. wherethe green arrow is, there's a very small prostatic artery. i know that may be challenging to place amicrocatheter in because of its size. the angle by which it comes off the anterior divisionof the hypogastric artery is not particularly challenging. and the actual anterior division,which here is paralleled by a red line, is fairly straight. so placing a catheter intothis artery and angling the tip of that catheter medially is actually fairly easy to do ina patient like this. however, on the next slide here, you'll see that we have patientsin which we use either a reverse curve catheter like we did in the previous, or we use a waltmanloop, which interventionists are familiar

with using a cobra catheter and then tryingto direct or angle that catheter medially. unfortunately, in this patient in particular,because of common iliac artery tortuosity, torquing that waltman loop medially can bevery challenging. and no matter how much you torque the catheter, the distal tip stillwants to point laterally and that can limit our ability to select a medially orientedvessel. so on the next slide, we're also limited by things like a steep aortic bifurcation.here, in which the angle is about 15 to 18 degrees, getting a catheter up and over thisbifurcation may not be so challenging, but having the catheter stay there while you performdistal embolization or catheterization, that can be more challenging in which the proximalcatheter may back out.

on the subsequent slide here, you'll see ipsilateralhypogastric artery angulation can offer the same challenge in which we may place the catheter,not just via waltman loop, but directly into that hypogastric artery and that angulationcan also limit our proximal support. here is what i was talking about in terms of acutelyangled origin. this angle, as you can see here on the slide on the left with the redarrow, is pointing to a vesicle prostatic trunk. so it gives origin to the vesicle arterywhich goes to the bladder superiorly, and then that tortuous artery which extends inferiorlyis the proper prostatic artery. that acute angle is very challenging to negotiatea microwire, a microcatheter unless you have good proximal support, and not only that,support which actually angles medially so

it allows proper selection of that vessel.that angle is very commonly seen in patients in which there's a vesicle prostatic origin.in patients in which the prostatic artery arises from other origins, that's not oftenseen. but in this particular example, it is. on the right slide here, you can see a similarexample with the vesicle prostatic trunk. the straight vessel which arises off thatred arrow and the branch that goes anterior to the bladder where that curved arrow thatgoes anteriorly is the prostatic artery. unless you have good proximal support or proximalangulation, then it's very difficult to put that micro catheter distally into the prostaticartery. on the subsequent slide here, you'll see this is a case in which we failed selectivecatheterization on the left picture. we failed

selective catheterization because we couldnot get our waltman loop angled medially, and subsequently get our microcatheter intothat first tortuous artery that makes a complete reverse curve and then goes down. subsequent to that, we brought the patientback. and you can see here, this is actually a robotic 6 french guide catheter, which isplaced, and the tip is angled just to the origin. and on the picture on the right, you'llsee the catheter extends just distal to that radiopaque marker and is seated right at theorigin of that really tortuous artery. so then on the subsequent slide, you'll see wewere able to place our microcatheter distally here and it was placed using the robotic catheteras support in angulation. so we could basically

pick off the origin of that vessel and thenadvance our micro catheter distally. and you can see on the image on the right how hypervascularand large its prostatic gland is. so despite having a massive prostate, it stillwas very challenging. the robotic catheter in this case, we used very successfully ina patient who we failed initially in the pre-robotic error, if you will, for us. similarly herein that case i showed with ipsilateral hypogastric artery angulation, how do we get over this?you'll see on the next slide, we could take that 6 french catheter and perform angulationby angling the proximal articulation point away from the hypogastric artery origin. andthen using our distal tip angulating it medially and then feeding it very well into the hypogastricartery and then driving that catheter down

into the anterior division, as you'll see,and then performing prostatic artery embolization from there. so not having to perform a waltman loop andthen manipulating this catheter, it's fairly straightforward. and you can see, withoutgetting too confused here with some terminology, the actual arc that is performed on that distaltip of that catheter or what i like to refer to as the tightness of the curve, the abilityto curve the distal tip of that catheter is so acute that it allows you to actually performa selective catheterization of a vessel that's completely 180 degrees from the origin ofthe parent vessel. and you can see here from these videos that advancing that catheter.

and in this case, we're advancing it overa glide wire without the leader catheter, just the 6 french catheter alone over theleader catheter into that hypogastric artery very successfully to the anterior divisionand then subsequently being able to perform, as you'll see on the next slide, our prostaticartery embolization. and in this case, if we can go back just one slide here, we advancedour catheter in. that middle picture is just to demonstrate how tortuous this artery actuallyis and how well this 6 french guiding catheter or robotic catheter can be advanced over thatwire without significant difficulty. and i think that's important, because whenperforming prostatic artery embolization, what i always tell our techs, is the controlateralside is often not as difficult as the ipsilateral

side. this has really reduced our time inipsilateral prostatic artery embolization. on the next slide here, you'll see, this is[inaudible 00:13:26] by that tight radius. if you look here, before we perform our selectedcatheterization, this is a complete 180-degree selection of that hypogastric artery. buton the right, in the video here, the [inaudible 00:13:37] image, you can see that distal tip. we basically curve on itself and then selectand then perform a hand injection through that guiding catheter, and it gives us greatimaging of the hypogastric artery and subsequent branching. and we don't even need to use apower injector at this point to do our subsequent injections. on the next slide, you'll see,this is another example of us driving that

catheter into the hypogastric artery distallywithout an issue, both on the ipsilateral side, and then you'll see on the image onthe right or the video on the right, on the contralateral side here, we're driving thatcatheter all the way into the obturator artery. so clearly, it can be driven very distallyin both examples. this is even without the leader catheter. i think initially it might be nice to use,but we found that actually with distal or target embolization for pae, we've been verysuccessful without it. it's actually streamlined our workflow. here's an example of where youneed to angulate the distal tip of the catheter to bring your catheter tip to the origin ofthe prostatic artery and then perform an easier

selected catheterization. where the red arrowis clearly where the distal tip is of the robotic catheter, but the anterior division,as you can see right at the origin of that very small prostatic artery, is where thegreen arrow is. and what we can do here is just use our eitherbedside control or tableside control or our remote work station and articulate that distaltip, and then use our microcatheter and it's seen now right at the origin of that vesselor the anterior division. and it allows us a less frustrating experience in not havingto select that superior gluteal artery repeatedly and allows us to advance our microcatheterinto that prostatic artery. on the subsequent slide, you'll see another example of this.here we wanted to bring our distal catheter,

6 french robotic catheter, into that anteriordivision where it bifurcates here into the gluteal and pudendal artery. we've brought our 6 french catheter, as you'llsee here, all the way down into that bifurcation of prostatic artery and pudendal artery, andthen subsequently brought our microcatheter into the prostatic artery to perform the embolization.so it can not only be used in the hypogastric artery, in the anterior division, but herewe brought it down even into the internal pudendal artery to then perform our subsequentembolization. as you'll see here on the next slide, this is another good example of distalangulation. we use our microcatheter here after getting that catheter in the hypogastricartery on the left. we used our catheter,

angulated it again into the anterior division. you can see how small that vessel is, probablyperhaps five or six millimeters, and able to bring that catheter into that vessel withouta problem. on the subsequent slide here, is an example of us bringing that catheter orthe 6 french catheter up to a trifurcation point. so we brought it up to where the inferiorvesicle artery then bifurcates into a prostatic artery, which you can see extending all theway to the left of that leftward image. and once we brought it to that bifurcation, ortrifurcation point in this example, we're easily able to bring our microcatheter downdistally, as you can see on the image on the right. and that's a great example of prostaticartery perfusion, as you'll see, and how distal

we take that microcatheter basically intothe gland before we perform our embolization. so why is proximal support so important? withsmall target arteries, it's obviously important to have proximal support. because as you'readvancing your microcatheter, it's easy for a 5 french catheter or even a [inaudible 00:17:05]sheath or proximal sheath to back out. but with this robotic catheter, it takes on afixed position. so that proximal support is very important and it does not back out. inan easier selected case like this where the vessels are not very tortuous and you cansee they all take up to angles, proximal support may not be as important. but unfortunately,this is not the typical location in an elderly male.

on the next slide, this is actually threedifferent videos where i wanted to show you the example of what that distal articulationdoes. you can see here on the video all the way on the left, as we're just articulatingthe distal tip, we're directing that distal tip towards the prostatic artery. in the videoin the middle, once we direct that catheter tip medially, now we do a hand injection.and you'll see with that hand injection, we now can pacify three different vessels: onegoing laterally, one going medially, and then in the middle that really tortuous doubles-shaped vessel is the prostatic artery. and here on the video on the right, withouteven using the microwire because of that proximal support, that microcatheter is able to beadvanced into that prostatic artery with very

good proximal support, maintaining the integrationlow, and then a very tortuous artery. so this is a perfect example at how that distal navigationalability really allows us to select a normally difficult vessel to select. here's an examplethat pushability. so if we need to get that catheter all the way down into the gland,you need that proximal support in order to get that distal. and this is just to show how distal we takethat microcatheter before we perform pae. on the next slide, you'll see here. so thisis the next slide where we can demonstrate, even when we lead that 6 french catheter wayback here, this is in the anterior division of the hypogastric artery, that microcathetercan still be advanced very distally, as you

can see here on the slide on the right, intothat prostatic artery and perform our pae. so the support is still there, even with aproximal placement. and i think that's really important where the 5 french catheter, asmost people know, when you're performing advanced embolization in the pelvis, especially upand over the bifurcation, that catheter can easily back out on you if you're trying toadvance your microcatheter very distally. so last thing i want to talk about reallyquickly is this hypogastric artery knuckle. so we go to the next slide here. this is basicallywhere you see here this orange circle. in elderly men, the hypogastric artery, as itbifurcates, forms this knuckle where it travels from a posterior location to an anterior locationand distorts your 5 french catheter. so although

you're c2 catheter, roberts catheter, or anyangled catheter you want to direct medially towards that green arrow where the prostaticartery is, when you bring it through this knuckle, it tends to direct laterally. and unfortunately, despite any torquing thatyou do to the catheter, that knuckle in the hypogastric artery can malform your catheter.and you can see that here, as evidenced by those white arrows here on the right. so onthe next slide, you'll see the normal solution is to take a 6 french sheath, which can befairly painful, however rigid, and use a buddy wire, as you'll see here on the blue arrows.and in this case, we used a shorty wire to straighten out that sheath and try and thenredirect our microcatheter into the prostatic

that's very challenging. and unfortunately,that does not work very well because now you have to go a bigger sheath. because you haveto allow to accomodate both your buddy wire and micro catheter, and the two do not torquevery well together. so as you'll see here, the solution with the robotic catheter isonce you bring it through as you can here, and here's our target here with the red arrow,you can see our robotic catheter going through the knuckle here. once we bring it through,now we can angulate that distal tip however we want and it will fix our position. and in this case, we angled it to the originof that vesicle prostatic trunk and it allows us to then select that target vessel withoutredirecting a traditional catheter into the

wrong vessel. so here, we want to get intothis white line or prostatic artery, and this can demonstrate how we can get all the waydown to that origin through the knuckle without a problem. on the next slide, again, samething to show here: medial angulation. once we bring it past the knuckle, you can seethe difference between the left slide and the right slide, is that the angle of thecatheter here, we just directed it medially. and that's really important. so one more example here to show distal support.you can see here on the video on the left, it's a [inaudible 00:21:24] image from a handinjection. at its very first branch is a very short trunk or a vesicle prostatic trunk,and this is another example of why you need

that proximal support because of that severeacute angulation. as you can see here on the right, its that first branch and then thedouble s-shaped curve vessel. and that is really important and critical. so we can moveon here. in this last couple of slides, it's just to show exactly that last case. we were able to take that glide wire intothat vessel, bring the robotic catheter down to the origin, and then you can see here onthe slide on the right, bring our microcatheter into that prostatic artery and subsequentlyperform our pae very successfully. so this really comes to prove a real advantage forus in terms of our pae procedures. in terms of data for pae, my personal feeling, thereare issues to work out in terms of reimbursement

in future prospective clinical trials, butpae is definitely here to stay. the data is very supportive of doing the procedure, andi think that's really important. the biggest issue with the procedure besidesfive clinical trials and prospect clinical trials will be the technical challenges associatedwith the procedure, and i think that's going to limit the widespread adoption. this iswhere the magellan robotic system i think really shines. it's really offering us thepotential to improve the procedure in terms of ease, consistency, reducing our radiationdose because we can actually stand four feet or more from the patient's pelvis. and thenin terms of marketability, there's an undeniable fact that intervention radiologists have beenlimited in their ability to market their procedures

and because of the way they get referralsfrom other physicians. and i think that this system can offer us a real advantage in termsof marketability. and so besides just making our proceduresconsistent and allowing us to take advantage of the robot in terms of difficult proceduresin which we wish we had the robot and we didn't before, these advantages have really cometo fruition for us. we use it now on every case that we can in terms of pae, and it'sreally, like i said, improved both our ease and consistency. so in conclusion, that'show i'd like to end. and brian, again, thank you for the invitation to speak to this audience.