I'd like to thank Dr. Schmueler and Dr. Waxman, who I've worked with now, Alan, since I think 1992. But Dr. Schmueler, not quite as long, but quite a while, and they've contributed a number of the slides, including particularly the pictures were shared. The other thing is that this is a very sort of U.S.-centric in terms of the guidelines that we're going to discuss in ASCCP, but what I was going to focus on is just the actual LEAP procedure itself, and not so much when to do it and the follow-up of it because that's going to vary so much depending on, not even only internationally, but in the U.S., depending on what resources an individual clinic might have and how challenging it is for a patient to get referred elsewhere. So we're just going to focus, there'll be some guideline discussion, but I'll probably skip over that and move quite frequently or fast through that. I do not have any relevant financial disclosures, and we're just going to go through the indications and more the technique of LEAP, some of the risks that are associated with the LEAP procedure, some of the complications, particularly around pregnancy, that can occur, and then what the failure is in terms of how often people do recur after they've had a LEAP. So there are treatment, a lot of treatment options now for cervical dysplasia. You can have active monitoring for high-grade and low-grade. You can do, in the United States, there's still some cryotherapy being done. Internationally now, thermal ablation is being done a lot more, and it does destroy the entire transformation zone. But LEAP is what we're talking about today, and the excision, LEAP is really the predominant method of doing that, as was mentioned towards the end of the last presentation. Cold knife cone still is available, but requires, it should be a very limited number of people who really, that cold knife cone should be considered for, and obviously it takes more resources in terms of an operating room and typically anesthesia to do that. And probably the biggest advantage of the excision procedures is that they provide tissue for the histopathologic evaluation, which obviously the ablation techniques do not do. It was first introduced in the early 1990s. Dr. Waxman and I actually learned how to do LEAP together from a faculty member that came to visit us in Gallup, New Mexico. It has a lot of advantages, but primarily that you get a specimen obtained that you can evaluate, but in general it has fewer side effects in terms of the amount of discharge and the healing process afterwards. Again, who should be treated with excision? Again, I'm going to skip right over this because there are different variations on this, but typically, you know, AIS needs an excision, high-grade lesions are treated with excision, and then others in other circumstances can be. Corey, this is an ASCCP recommendation that if you have a risk of a high-grade lesion that your risk of ongoing to cancer is, or that the immediate risk of CIN3 or greater more than 4% that you should move towards considering ablation. And then this is talking about expedited treatment. Again, if you have a very high chance of having a high-grade lesion or beyond, then you could just, without going to colposcopy, you could just based on the original evaluation. And then those that we look at for cold knife cone, particularly if you have a lesion that you're suspective, either based on their cytology, their appearance, or biopsies of microinvasive disease, there should be, most people would think about that because they're more concerned about margins and not having any thermal damage, if you have a concern for adenocarcinoma. And then similar to what we were talking about before, that if you have, you know, the cervical os is obliterated and you can't really see, the anatomy is distorted, that sometimes a cold knife cone procedure would be more advantageous than doing an excision, I mean, a lead procedure. So just some general things to think about as we're treating, is that, as was sort of mentioned by Blaise, is that if you can see the transformation zone, that that's very reassuring because it's thought that the vast majority of lesions begin at the spramular columnar injection and then migrate in or out from there. And usually that the most central, severe lesion that you're going to find is usually the most central to that. And so we were wanting, so because of that, we want to treat the entire transformation zone. And so you want to excise circumferentially to a distance of at least two or three millimeters beyond the furthest lesion and make sure that you get the entire transformation zone. I know when LEAP first came out, there was discussion about, could we just remove the individual lesion and be specific, and that is not as successful in terms of treatment. So we're trying to get rid of the entire lesion. And you want to go to a depth of about five to seven millimeters because, and you want to make sure that you get deep enough to get the endocervical glands, and so that five to seven millimeter range is typically enough. There are some contraindications. If you look at a cervix, like the one over on the right, and you have, you know, purulent material there, that would be an indication perhaps not to do the LEAP at that time. Pregnancy is a contraindication. And then the other things are much less common in terms of, you know, there might be somebody on anticoagulant therapy, but they may have a demand pacemaker. But so those are less uncommon. It's usually the cervicitis or pregnancy that are the two things, or that you have suspected microinvasive or actually invasive disease via relative convocation, as we already talked about. Just some brief principles of electrosurgery. There are basically three types of current that we use. The cutting current is a high-frequency alternating current that has very positive alteration and creates a very high temperature very quickly. You get a steam arc that develops with that heat, and so it actually, what you're cutting with is basically vaporizing the tissue. And so because of that, you can, if you don't remember the exact mechanism of why, but it's important to remember that you have to move continuously as you're doing a LEAP. A lot of times with learners or people that have not done a lot of LEAPs or don't do them very frequently when I'm supervising, they'll, something will happen and they'll stop. And then once you've stopped mid-LEAP, it's very hard to get, you have to regenerate that heat, so you actually need to pull the loop out and essentially start over. So you really want to make sure that you're able to do the LEAP in one continuous motion, if at all possible. You can also use a coagulation current. This is a little bit, it's short burst of a moderated voltage, so it actually heats up slower, and there's more thermal damage associated with this, which is why you can then actually coagulate with it. But what most people use for their LEAPs, and most machines have this setting, is a blended current, which is primarily cut, but it also has a component of a coagulation current. And you just get, you get a decent margin with this, you don't get a lot of thermal damage, but you do get better hemostasis than just using a cutting current. So that's what most machines are set to do. The components of a LEAP, they all, they can vary a little bit as to what they look like, but you need some sort of generator. This is a fairly large one that has a variety of different settings that can be. Others can be much smaller than this, but just have one typical setting to do it. You need a smoke evacuator, which is really important, because as soon as you touch the tissue or start your procedure, you're going to generate a large amount of smoke, and you very quickly can not see anything because of the smoke in the upper part of the vagina. Some machines have this as an automatically, it's attached to your generator so that when you deploy the current, whether it's with a foot pedal or a pencil, the smoke evacuator will come on. Others are separate, so depending, if you're using different machines and you're not familiar, make sure that the smoke evacuator is going to come on when you start. A critical component is the return electrode or dispersive pad. This needs to be attached. It can be patched, but anywhere, typically, we put it on the upper thigh so that we can see it and we know that it's in place, but it is very important. Most machines now have a default safety system that if it is not completely intact, that it will not activate, but I have used machines where that is not the case, and it won't tell you that what's going on is 21-bit. You then have an electrode, and we'll see this in a minute. We have a loop that we use for the actual excision procedure and then a ball electrode, which is very useful for coagulation and for hemostasis, and then you need to use an insulated speculum of some sort. There are a variety available, but just something that does not conduct because if you don't have some sort of insulation to it, if you touch it and it disperses electricity to the vaginal wall, that's not good for many reasons, and many of them now have a built-in, or most of them have a built-in smoke evacuation port that you can just hook your tubing up right to the speculum, and that is very effective in terms of evacuating the smoke. Some basic precautions, make sure that they don't have any jewelry, particularly that could be touching metal because the current could then use that as a grounding, so you want to make sure that any metal jewelry is removed, that the pad is completely in place. A lot of times, we're using disposable materials, so you don't have to worry too much about it being frayed, but in many clinics, they are reusing some of the instrumentation, so you want to make sure that it is in good shape, and again, we've talked about allergies and checking for pacemaker and things like that. So before starting it, it's important to, I mean, in a lot of instances, and I know where I'm currently in practice, that the patients are referred specifically to LEAP clinic. They've had their pap smears, their pulposcopy biopsies, and in many cases, a decision made that they need a LEAP, and then they go to a clinic being seen by a provider that may not have seen that patient before. So it's important, if you're the person doing the LEAP, to review the pap and pulposcopic findings. Blaise, your system where you're using pictures is excellent, because that's not always the case, and I know for years, we tried to interpret what somebody's hand-drawn picture meant, but I always just do the pulposcopy myself, again, before I do a LEAP to make sure that I am as familiar with the patient and their condition as I can be. And always do a timeout before the procedure, and again, I do a repeat colposcopy to make sure that I can see the lesion, that something hasn't changed. Also, oftentimes, the time has elapsed between the time they had their colposcopy and now that they've gotten to LEAP clinic. So it is not unusual to see some changes, potentially, as what was there before. Whether to use Lugol's or not, I am not a huge fan of Lugol's, because it makes, for me, I find that it makes the vaginal canal very dark, and makes it very hard for me to do that, to finish the, you know, do the procedure. On the other hand, if I'm having difficulty seeing a lesion, and sometimes it can be helpful. So know that it's available. I know that there are certainly very senior, experienced people that prefer Lugol's with all procedures, but it, and again, as you're going through the learning process about LEAP, I would encourage you to try both ways and see which works best for you. It is important to use anesthetic. The cervix does not have a lot of pain fibers, but it does have a lot of pressure fibers, and it will…patients will…they do need some sort of anesthetic. It's an intracervical block as opposed to a paracervical block, which many people do a lot of paracervicals for…whether it's for endometrial biopsies or IUD insertion, but this is an intracervical block. And you see the needle is going right into the cervix, and there are a number of different ways that are reported. What I have found very helpful or useful is just to go at the 2 o'clock, 12, 2, 4 injections every 2 hours around the cervix. You want to use something that causes some vasoconstriction. 1% lidocaine with epinephrine is prepackaged in many instances, so that makes it easy. On the other hand, epinephrine causes a lot of tachycardia and can cause some palpitations that can be a little unsettling to some patients, so I prefer vasopressin if it's available. And, again, you want to inject in several sites, and usually I wait several minutes. You want to make sure that it has taken effect in a way that I…the timing of it varies from patient to patient a little bit. But what I've found is when the injection sites stop bleeding, and that usually takes 2 or 3 minutes, that means that the vasoconstriction is working and that's given enough time for the anesthetic to work. You can do it through the colposcope, or you can actually do your colposcopy, move the colposcope out of the way, and do it under just gross vision. I prefer doing it through the colposcope, but it does take a little bit more coordination because the colposcope is kind of in the way. Again, you want to remove the entire transformation zone. We already talked about the depth and the width beyond the lesion. And I found it really helpful, particularly with learners, or if I'm supervising someone, to actually make a practice pass to actually, you know, without the current on, is to put the pen…the pencil together, take my loop electrode, make sure it's big enough, and I envision where I'm going to swipe, whether it's from side to side. In some cases, it's up to down, but just do that and make sure that you have a good sense and you've got enough retraction so that you can see the lesion completely. And then I typically use a blended cut. And again, it can vary from generator to generator, so sometimes it might take a little bit of adaptation if you're using a new machine compared to what you're used to. And they're a different size loop, so you want to make sure, again, doing that practice pass, that you have the right size loop. If you have a very small lesion, you might need to, you know, get by with a much smaller loop than the much larger that you might need for some. Again, try to do it in one single movement from side to side. And sometimes we do what's called an endocervical top hat, and I won't go through all the indications for that, but there are several that it can be beneficial to do that. And I'll show a picture in a minute as to what a top hat looks like. And if you have a lesion that there's just no way that you're going to get the entire lesion, so in this case, this is a fairly large lesion, so you could… I made the determination, let's take this piece out with our initial pass, and then you need to get this because you just weren't able to reach that high to get it with your loop. So, you can excise that separately if you need to. After you've done the procedure, then you use the ball electrode that I mentioned before, and you can't see it as well. This is the ball, but you actually just use it, and I usually use this on coagulation, and you can actually, if you depress the generator or activate the generator and hold the ball electrode just slightly above the tissue, you will get a spray, and then you can pulverate the tissue. You can also use Mons cells if that is helpful, particularly if you just had some slow oozing, and some people use Mons cells routinely, but usually it's the cautery that will control the bleeding. It's recommended to not directly cauterize the endocervical canal because that might increase stenosis, and it's rarely bleeding from there anyway, in my experience. Then, depending on your pathologist, and I found over the years when I've worked with different pathologists, some find it very helpful to have it pinned or tagged so they know what the 12 o'clock position or they know what the orientation of the cervix is. I've worked with other pathologists that say, you know, I really don't, it doesn't matter where I find it, so I'm not going to give it to you, and so I would say work with your pathologist to know that. If you have any doubt, go ahead and put a suture or pin it on wax or something so that it is identified. And this is a top hat, and it's just because that, so this is in cross-section, the excision from the primary leap, and then you're just trying to get a piece of tissue higher up into the canal without taking all the surrounding tissue from the cervix. So you're just following the canal and going up. It's a separate, small, little, typically five millimeter top hat curette that you can use. As far as post-op, most patients don't need any real significant pain relief. Ibuprofen or acetaminophen usually works more than adequately to control most people's discomfort. Depending, it's really individualized. I tell people, if they can, to plan to take that day off, because you never know how much cramping or anything, but most people can resume their normal activity within one to two days. So I usually tell them to plan on, they could go back to work the next day most of the time. I would recommend avoiding intercourse for at least several weeks, up to four weeks, because it can increase bleeding afterwards. There's no real support that they can't do heavy lifting or vigorous exercise, but that we include that in our instructions. And then precautions, most importantly, about if they develop any fever or foul-smelling discharge or increasing pain or significant bleeding, that they should come in. Most of the time, the bleeding that people experience after leave is mainly just mild spotting or pink-tinged mucus. It's unusual to have active, heavy, bright red bleeding, so that's an indication that something's going on. So complications that you can have, you can get interoperative bleeding. It has happened more than once in my experience, and it's unpredictable. Most of the time, we've injected and we've used some vasopressin, either vasopressin or epinephrine, and still you just happen to hit a vessel that does start bleeding. And every once in a while, you might have to, most of the time, just moncells or cautery is adequate to get it controlled. Every once in a while, a suture might be necessary, but that's unusual, but you need to be prepared for that. Delayed bleeding usually happens at about 10 to 14 days, when you perhaps might have an eschar that someone has intercourse or whatever. It just breaks off and starts bleeding. And again, that usually can be controlled with just moncells. And perhaps if you were in a situation where you can, you could, again, cauterize it again. Cervical stenosis is also a possibility afterwards, particularly in postmenopausal patients. I think it was Dr. Waxman mentioned doing an ECC after somebody has had a leap or two might be difficult to continue to do. Most of the time, it heals reasonably well, but it does happen. You can get thermal artifact of your specimen. So that's something that every once in a while, and I've found this, particularly in beginner practitioners that are just learning, that they end up with more artifacts. So, like, for instance, our clinic, when we have a beginning learner, they're the ones that do sort of the straightforward leaps that we know are going to be relatively easy and have a very, very minimal chance of having a higher grade lesion or AIS, for instance. And so patients that are really high risk or concerned, we have somebody who's more experienced do that one. So if you are in a teaching situation, unusual, but it can happen. If you can get unintentional burns, we already mentioned, I mentioned earlier that using the insulated speculum is important, but you can also every once in a while, the patient jumps, something happens. You can touch the vaginal sidewall with the with the electrode and that can cause a pretty significant burn as well as a lot of pain. So avoid that as best that you can. And again, practicing, using, getting the right amount of retraction and everything can be very helpful for that. And there are a variety of retractors that that you can that come in an insulated fashion so that you can use those as you need them. Stenosis is pretty uncommon, but it certainly can happen. I already mentioned, try not to to cauterize the. The the us directly if you can, obviously, you want to get bleeding control and everything, but most of the time you can have a specific. Cervix that look just like this, where you've been able to cauterize the bed and you've left the us untouched and just a little bit about fertility there. It doesn't seem to have any impact on the ability to conceive. It doesn't change the time that patients have to get to conception doesn't seem to really change the. Total number of live births that are associated, but what it does is it has been associated with preterm birth. And, you know, really systematic reviews of this topic have pretty much concluded that it's not an incredibly high risk, but it does increase your risk. A preterm birth significantly, and here's just a summary of that. We won't go through that in general because I know we're approaching time here shortly. It does seem that the more tissue that you take out the. The more likely there is to be associated with preterm birth. So cold knife cone again, 1 of the advantages of moving. To leap excision over cold night cone is you're not removing as much tissue, but you're still as effective in term treating the disease. And so the depth and the volume of tissue, and the number of leaps that you have performed. Has an impact on the preterm birth rate afterwards. And then recurrence there, there is a recurrence that can happen. Fortunately, it's very low, usually in the single digits. And has some. Association with age and the older you are, the more likely it is that. Your recur and what's your original disease was so it is important and we won't go through the follow up specifically. But you should follow the guidelines appropriate for your population. To, in terms of whether how to do that, because there is a recurrence rate. Uh, most of that recurrence does occur within the. 1st, few years, um, and over some term between 5 and 10 years, the recurrence risk typically returns down to the baseline population. So. If margins are involved, which again, going back to 1 of the advantages of having. Is that you have a margin that you can assess and people that have a positive margin do have a much higher. Incidents of recurrence, it doesn't come back as cancer. And I talked to patients about this because it sometimes causes them some angst. Well, I have a positive margin. Don't you need to go back in and take it out right now? And it's like, no, we can continue to follow you. And. Um, you don't need to have a right then, but it does, it should. Increase your awareness that they need to follow up. And again, these are guidelines I'm going to go over them. There are different. Ones that I know are used in different settings, but. As long as you have a plan and you're getting patients back in for follow up is really the key after doing so. So, summary leap is very highly effective. In treating high grade dysplasia, it can be very safely performed in an outpatient setting. Uh, it's in many instances, the preferred means of treatment. It does give you a specimen that can be evaluated. Uh, it's very well tolerated and, um, but patients do require follow up afterwards. I think I finished 1 minute late. Sorry.

LEEP

cervical dysplasia

electrosurgery

complications

preterm birth

outpatient treatment