Direct Visualization Can Transform Your Practice – Dr Craig McCoy

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We are pleased to provide this educational opportunity on behalf of Cooper Surgical.

Welcome, and thank you for participating in tonight’s webcast program. Direct visualization can transform your practice.

My name is Christine O’Hare, senior product manager of NOC Advance, and I will be your meeting host for this evening’s event.

First, just a couple of notes and how the presentation will run. We will have approximately thirty minutes for the presentation then to follow a question and answer session given by doctor McCoy.

To submit a question, you may do so by clicking ask a question button located under the player window and kindly fill out the form. If time does not allow for all questions to be answered, please know you will receive a response by Cooper Surgical after tonight’s program.

Doctor McCoy currently practices at Moberly Regional Medical Center located in Missouri as he is board certified in OB GYN as well as board certified in female pelvic medicine and reconstructive surgery.

Now I am pleased to announce tonight’s speaker, doctor McGaughey.

Good evening. It’s, indeed a pleasure to be here spending, some time with you on this important topic, that we’re going to address tonight, on visualization of the endometrial cavity.

Some of the housekeeping things that we’d like to, start off with is my disclosures. I am a paid consultant and speaker for Cooper Surgical. I also, do consulting and speaking for Apex Medical as well as Allatrobe Medical. So a very talented individual, doctor Anderson, who is on a faculty at Vanderbilt, really sums up, very nicely, all of what we’re going to talk about tonight. And he says, very eloquently, the ability to look inside the uterus and diagnose anatomic abnormalities, that affect the reproductive health, of underlying disorders is invaluable.

It’s the same as was mentioned previously.

You go to near nose and throat, they’re they’re gonna look with an otoscope. They’re gonna look inside a cavity to see. We have imaging.

We have ways to do x rays, etcetera, but there is no substitute for actually looking inside at tissue to know what we’re dealing with. And then to take this to another level and able to do this in the office, it’s not only a benefit and convenience for your patients. They’re very busy. They’re very active individuals.

As we know, women as the caretakers of their family, it takes a lot to get them to stop and care for themselves. So when they come to you as a provider, they want answers, and it’s incumbent on us to try to provide them with an answer as expeditiously as we can. We also wanna make it convenient selfishly for ourselves. Can we get to a diagnosis in an early, easy manner, that can then be less costly for our office as well as the health care system as a whole.

So looking at the cavity with hysteroscopy, I hope you’ll follow along with me during this presentation. We’re going to build that argument of where this has a place now in the twenty first century. It’s state of the art and what all of us as practitioners should be considering.

Abnormal uterine bleeding.

We all face it. And back in the, days when I was, starting my training, we tried to quantitate, what abnormal bleeding was. Now some of you have probably are old enough as myself. You’ve seen, well, we have eighty milliliters of, blood, throughout this, time of bleeding or the menstrual cycle.

Well, none of us really quantitated that. Well, now we have it’s anything that is considered outside of normal. Whether it’s a cycle length, duration, the amount of bleeding, we can now put into that picture of abnormal uterine bleeding. It’s making up approximately thirty percent of all of our gynecologic outpatient visits.

Now if you take this another step, and we’re gonna look at our perimenopausal and postmenopausal women, we know that that is a group of women that has a higher percentage. It’s up to seventy percent, are going to be having dysfunctional or abnormal uterine bleeding. What we can see down here that this palm colon system by FIGO was established to try to help us, to have a mnemonic here of what are we looking at? We’re looking at structural?

Are we looking at nonstructural causes for this abnormal bleeding? And this came about in two thousand and eleven.

And we found that about twenty to forty percent of abnormal uterine bleeding in women between the ages of thirty five at menopause actually had a structural cause. And we say that there may be something in the body of the uterus and the endometrial cavity, Oftentimes, something that we can treat and make better. If we don’t find that, there’s gonna be a non, structural abnormality. We’re looking at coagulopathy in the colon part of it, oblatory dysfunction, etcetera. We’re going to focus more on tonight let’s look for, simplistically, where is our structural problems, that we’re dealing with and using hysteroscopy in our treatment scheme here, our diagnostic scheme to better evaluate our patients.

Polyps.

We’ve all seen them. They’re all out there. We talk about them. And as we roll the video here and we look at this, we can see that about twenty to forty percent of women with abnormal urine bleeding are actually going to have polyps.

And you see here, here is a very common polyp right, at the lower uterine segment, and there is some length to that polyp. It is going up into the cavity, and you might say, well, gosh. Yeah. This is fairly large.

Are you going to actually take this out in the office? Probably not. But this is helpful, and the fact is I’ve got a large polyp here. I can now prepare a different setting, more so in the OR, to go there to take care of this polyp.

A blind biopsy.

We we refer to them as the piston pipe l.

As you look at that polyp on your picture on the left, and then when we looked at the video, you place that pipell in there, and you try to extract some tissue. It’s like a needle in a haystack. You’re gonna have a very high false negative rate. As you see here, this data is showing eighty eight point seven percent false negative rate.

Well, it makes sense. Your pipe bill is going to go in. It most likely will touch the polyp, bounce off, and it it’s really lucky if you get any tissue that you want. Then we have to realize, okay, are what’s the big deal about polyps?

And we all know that there can be some premalignant changes up to the point of twenty three, almost twenty four percent actually have premalignant changes.

Then even further, what’s even more worrisome is that group of one point five percent that have malignant degeneration.

That’s our goal here. Ultimately, we want to treat the patient, ultimately, we want to get their bleeding pattern better, but we also have to realize is that if there is a malignancy there, we have to be able to identify it, so that we can have a better prognosis for a patient.

Fibroids.

Here’s our fibroid in our picture that we see on our right. We all know that fibroids are very common. Lifetime risk, sixty percent.

It’s almost abnormal once you, you know, a woman’s lifetime that they have not developed a fibroid.

Our reproductive age women, you’re gonna see twenty five to forty percent. So they’re actually coming, to fruition anatomically very early in life.

The submucal one submucosal fibroids rather, they’re diagnosed in about five to eleven percent of women that are coming in with abnormal bleeding.

Here again, we need to point out the importance of that false negative rate. You look at this tissue. We know fibroids, any of us that have done surgery, you’ve done myomectomies, hysterectomies, etcetera.

You’ve resected fibroids hysteroscopically.

They are very hard smooth muscle tissue.

How can a pipel blindly placed in the endometrial cavity retrieve any of that tissue? It’s just not possible. So to do a blind biopsy, I I feel like the ninety eight point five percent and above is more, indicative of that. You may also see your fibroids. They’re associated with the abnormal bleeding, the pain. They’re we all see the pain and pressure patients, that are having, decrease in their quality of life, and there’s that subset of, patients that are going to suffer from infertility.

Hyperplasia malignancy.

This is our bad player. And you look at this photo, you can see, as cancer, we all know that as providers, there is aberrant development.

You’re starting to get more neovascularization.

You’re seeing all the blood vessels, torturous.

Look at the tissue.

Three point five, four percent of women, unfortunately, with abnormal uterine bleeding are gonna have malignancy. We have to be able to identify these. This is inexcusable. We need to find these to provide the best prognosis for them.

Once again, seventy five percent false negative rate. You do that biopsy and you place it into that cavity. As you can see by this photo, you have a high likelihood that you’re not gonna retrieve any of that tissue unless it is just global. It is encompassing over fifty percent of that cavity.

You have a high likelihood that you’re going to miss it. Now let’s look at the okay. You know, we have our patient. They’re coming in.

They’re having some abnormal bleeding. What are some of our risks here? Well, the overall twenty year progression to cancer, you have some complex hyperplasia without atypia. Even in that group, you have up to about a five percent chance that they’re going to develop malignancy.

What we really get excited about is if they have and I don’t mean that in a good way. We really increase, our sensitivity is if they have atypical hyperplasia, no one’s going to argue with that. There’s over a twenty eight percent or up to rather twenty eight percent risk that they’re going to in twenty years to develop a malignancy. That’s what we’re here to prevent, in our attempts at imaging and treating our patients.

Where does all this fit in? Well, back in nineteen ninety one, and I’ll have to age myself here a little bit. I was a third year medical student at that point. Doctor Stovall came out with a study.

And doctor Stovall, over the years has put out some fabulous data, absolutely fabulous data.

And he got us all excited when I get into residency in ninety two, and we’re going along and I was like, hey. Endometrial biopsies. Blind biopsies here. Pretty much equivalent to a DNC that’s blind.

He did a study with forty patients. They had known malignancy.

He after their group after, their hysterectomy, they compared the biopsy, to the histology specimen there, and thirty nine out of forty. They had a positive result for cancer. That kinda got us all excited. It’s like, this is what we need to do.

Well, others over the years have tried to repeat doctor Stovall’s study without success. And as you see here, some data that looked at blind biopsy for polyps here. As we mentioned previously in that that we saw the video, you place that in there. Most likely, it’s gonna bounce off the polyp.

You’re not gonna get the tissue that you want. Study here is very supportive of that eleven percent. You use a hysteroscope direct visualization, you’re up to eighty nine percent. Now let’s take that to another step.

They looked at myomas, the fibroids. Sensitivity, blind pipe l, not surprising whatsoever, thirteen percent, hundred percent. They were picking it up with direct visualization hysteroscopically.

Hyperplasia, twenty five percent, with a directed biopsy, or actually a blind biopsy, seventy four percent with direct visualization.

That is humbling to see, that what we believed was the standard to do our endometrial biopsies. In fact, we’re seeing that it had a very low sensitivity.

ACOG, they came out and they addressed this. And and most of us, we rely heavily on American College to give us some guidelines. And I think down here at the bottom where they say, you know, they’re they go through talking about, well, your adequacy of specimen is the disease, is it global or not? If you’re dealing with a focal lesion, your ability to actually pipes that may be as low as four percent.

They then came out with a statement and said, therefore, these tests are only an endpoint when they reveal cancer or atypical complex hyperplasia. That’s being stated. In summary, if you have a woman that you have concerns over her abnormal bleeding and you do an endometrial biopsy and you get back a nonatypical, no hyperplasia, no precancerous, they continue to bleed, you’re not done. You cannot stop at that point.

It’s their recommendation. No. If you get it back, you have your hyperplasia, you have some atypia. Okay.

You have now gotten into the group that you have a diagnosis that you have concerns. Prior to that, you can’t stop your evaluation.

We realize that there’s probably some, drawbacks to how we’re evaluating these patients.

We’ve been using transvaginal ultrasound, and I am not for one second saying, transvaginal ultrasound, it’s not the way to go. Absolutely not. I look at it as my patients that come in with abnormal uterine bleeding, that’s my ten thousand feet view of what’s going on. I get my ultrasound.

I’m looking at the adnex. I’m looking at the structures of the uterus. I’m seeing if there’s fibroids, etcetera. That I’m passing over at ten thousand feet.

Well, they said, alright.

We’re still realizing that we may be missing some polyps, some intracavitary lesions, etcetera. Well, the concept of sonal hysterography, taking some saline, infusing in the cavity, getting those walls to separate so that you can actually see some of the architecture on the inside of the endometrial cavity. This was very helpful.

And then we’re like, well, how does that gonna pair to hysteroscopy? You know, you’re still getting some images on a gray scale and looking at it. And I kinda look at it. Alright. We’ve come down from about ten thousand feet, and we’ve got a hangar at the airport, and we’re gonna fly by, you know, about a five hundred, six hundred feet. We’re gonna look in there. There’s the hangar.

There’s something inside there. Can’t really make it out. I’m going by very quickly.

Don’t know if it’s normal or not. We’re gonna maybe circle around and come back down and land and actually look inside being our hysteroscope. We’re gonna get a firsthand look at actually what we see in there. So we have levels here that we can separate out.

Sonohistiography, it has its place. It can tell you kind of vaguely, you know, is there something in the cavity, etcetera. But what we’re gonna see in some of the slides coming up, it’s not always as sensitive or specific as we want. They did a meta analysis that evaluated the diagnostic accuracy of hysteroscopy with overall success.

Look at this. Ninety six point six percent.

If you can see it, you can evaluate it. You can biopsy it. Tissue is the issue. You can get to it.

You can evaluate. We need to see it with our own eyes. We need to take that picture. Ultrasound’s great, but we need to get down on a level to actually see the tissue.

We have a study here by LeCroy. They had an their objective was how accurate is this saline infusion. What are we looking at? Well, they took saline infusion, some of the hysterography, and they compared it to transvaginal ultrasound.

Not surprising.

It was superior to that, but there was still some issues of specificity.

But no one would argue at that point. If we can get some fluid in there, we can separate the walls. Yes. It’s better than doing that ten thousand foot view.

Well, then they compared the SIS with hysteroscopy in several studies, And they found that out of seven studies, there was some similar sensitivity. Yeah. There’s some something there, but the specificity, that’s where if you wanna say it’s okay and it’s negative, you wanna walk away and feel good that you’re, hey. This patient is fine.

Well, they found that there was some issues with the specificity of SIS when you compared it to hysteroscopy.

That hysteroscopy is providing that direct visualization of the cavity. You can then directly biopsy it. As I said before, a little mnemonic, tissue is the issue. You need to get that, send it to the pathologist so that you can adequately and a hundred percent evaluate that cavity.

This graph does a beautiful job or this table rather of actually looking at a hundred and five patients with premenopausal abnormal uterine bleeding and also looked at postmenopausal and some infertility. Let’s look here. If you look at the top, you’ve got your transvaginal ultrasound, your SIS, saline infused soma hysterography, and your diagnostic hysteroscopy.

Look at your sensitivities and specificities. We’re doing any uterine abnormality.

Direct or rather your diagnostic hysteroscopy compared to transvaginal, eighty nine, ninety seven. It’s also better sensitivity than your SIS.

Come down to your specificity. That is kind of your money ball here. Ninety two percent versus fifty six and sixty. Moving on down to polyps, very you know, ultrasound transvaginal itself, you can make out forty two, percent.

Not very sensitive. Ninety eight percent, if you look in there with the hysteroscope, you’re gonna see it, versus eighty six for SIS. Specificity, once again, that’s what we need to be able to say, Ma’am, you’re fine. We don’t find any lesions.

We don’t find any precancers.

Seventy nine versus ninety one. Definitely superior for polyps, with a hysteroscope and fibroids as well. You look at a hundred percent sensitivity, with diagnostic hysteroscopy versus eighty and down to ninety nine versus ninety two on your specificity. So you can get some real reassurance for both.

You as a provider, you have to be, reassured that you’ve done everything you can for this patient. You have to be reassured that you’ve done due diligence for them, and you have to be able to express that to your patient. Ma’am, we have looked in the cavity. We have evaluated that lining.

I find no evidence of disease, or I do find a polyp. I do find an abnormality that we can take care of and provide you the best care. So why aren’t we all using this? What is you know, why isn’t it just in everyone’s office and we’re doing, office hysteroscopy?

Well, there’s a a number of reasons.

First of all, to get the equipment, the capital, to set up for that for a rigid hysteroscope, just the capital itself, is very difficult for an average GYN office even in a large practice because you have to have a return on your investment. I mean, medicine isn’t a, you know, is a business as well. You have to be able to decide, can I have return on my investment if I get this hysteroscope there?

Not only is the investment there that you have to be sensitive to, how much time is it gonna take up in my office?

Is my setup by my staff to sterilize, clean, prepare the room, all the equipment into room, or am I dedicating just one room square footage to that? It can be inconvenient on that basis as well as it’s taking up the space. It’s not as patient centric when you look at your traditional rigid hysteroscopy in the office. It, is, often felt to be associated with a fair amount of discomfort.

You will oftentimes need an anesthetic, so then you’re kind of losing some of the convenience of coming into the office without an anesthetic, quick procedure, going home. You’ve actually caused an inconvenience for that patient. And we go back to the expenses as well.

There is a finite expense associated with traditional hysteroscopy. So it’s it’s pushed us away from that, and it said, okay. You need the hysteroscope. Well, let’s go to the OR.

Okay. So what’s wrong with that? Well, let’s see. Let’s move along here and see how we can be better, by doing, office hysteroscopy.

Here’s our plan, and for the most part, I agree with it.

But if you look at you get your history and physical. We all do that. Our patients come in. We’re gonna draw some blood work, typically to see if they’re anemic, where’s their level of bleeding.

And we see here some offices will have ultrasound in their office, some of their large groups. Some of us have smaller groups. We don’t have that at our fingertips. So we’re referring those out to our radiology groups to do their ultrasound.

So we’re actually pushing that out into a second visit that they’re getting that done. It’s not a visit with us, but it is another visit that they’re having to undertake.

Endometrial biopsies, we’ve already seen what the sensitivity and specificity of that is. I feel that to just jump directly to an endometrial biopsy before doing any other type of diagnostic work probably is not in the best interest of the patient, but this is our traditional flow here. Alright. So they come back a second visit. Not many of us are doing saline infusion, somnostrostrophy.

There’s some talented individuals in their offices that are doing that. But for the most part, trying to get a radiology group to do that as well, sometimes limited. So we may or may not have that. So what if you do?

You can do that. You have then gone in. You looked. I see an abnormality in your cavity.

Well, that’s still obligating you to another visit. You’re not done there.

That’s gonna then propagate you into an outpatient planning, It’s gonna go to most likely, diagnostic hysteroscopy in the operating room. It’s gonna require an anesthetic. It’s gonna take a a day out of their, lives to go into the OR. They’re gonna have to have a convalescent recovery period.

Then you’re getting into treatment. So you have gone multiple days along this process in order to get to an answer. And as we said before, these are the caregivers for their families. They’ve often put things off to a point that they really shouldn’t have, and we’re asking them to come in, be patient with us, and take them through this evaluation process that is actually quite timely based on this.

Looked at the cost effectiveness of this.

They wanted to look where their office hysteroscopy actually decreased the need for going to the operating room and what were the financial implications of that. And if you can see over here, they had a hundred and thirty patients. It was in an academic setting, and they found that forty two percent of the time, they still needed to go to the OR. Okay. Less than half. But more than half, they could avoid that. So each time they avoided going to the OR, there was a savings for the patient of about thirty five hundred dollars, minimal to no pain with a thin flexible hysteroscope in the office.

So you looked and we saw that one video at the very beginning. It had that large polyp that was sitting there. Okay. I’m gonna be prepared.

I’ve got an OR day. Most of us, once we get into a very active surgical practice, we have x amount of days that we can go to the OR. When we go there, we need to maximize that time. Well, if we’re going in there for just a straight diagnostic hysteroscope and looking around, something we could have done in the office, that’s not efficient.

That’s not providing more care to patients who are having, conditions that need, more complex procedures. But if you look here and you say, hey. I’ve got a large polyp. It’s extending up into the, cavity of the uterus.

You can then prepare. You can have your staff say, yes. Get this resection device ready. Have it deployed.

Have it on the back table. You can consent and counsel your patient for that. They know what to expect when they’re going to the OR. You know that you’ve been able to dilate, get into that cavity.

You’ve not gonna have as much concern around perforating the uterus. You can get in, get done what you need to do.

We see over here on the right, the cost breakdowns here. Once again, office hysteroscopy, thirteen hundred dollars, essentially five thousand going to the operating room. This is older data.

I think as the economy, we see that this is probably actually going up even more on the OR side.

Cooper Surgical. Why is it that I feel inclined to speak on behalf of Cooper? Well, I can tell you in my twenty five years of being a gynecologist, I’ve been surrounded by Cooper. Oftentimes, I didn’t even know it.

I have used products in both an outpatient setting in the operating room, and it wasn’t until I really started piecing things together. I’m like, wow. This is a company that is patient centric for those the female population. They have a mission to deliver practical solutions in a timely manner in an in a compassionate way to get, answers for them, provide treatments, so that we can continue to provide the best care.

I can’t tell you what an impact it has on me daily in the office. What it has on me is an impact weekly in the operating room. And for that, I am very, humbled by this company. So it’s a pleasure for me to speak on this product.

And I wasn’t surprised when Endosy came along, for office hysteroscopy. It was just a natural extension of their vision of what they can provide in women’s health. We have here a state of the art direct visualization now with the Endosy Advance. They had their first generation, came out with their five ten clearance, and I, in fact, really enjoyed using even the first, generation of the Endicine.

But what I’d like to point out is out in the, in the, gynecology, genre there, you had providers that said, hey. I don’t really appreciate maybe some of the width at the tip. I don’t feel like the cannula, as you see here, is rigid enough so that I can easily get into the endometrial cavity.

We need an operative port. We need to be able to biopsy, lesions in the uterus. We need to be able to manipulate IUDs, etcetera. What happened?

Cooper Surgical, they listened. They went back with their engineers. They did planning. They did their due diligence, and now we have our next gen here, the end of the advance, which I am extremely pleased with.

And now I have a tool that I can actually do operative procedures in the OR. I can do diagnostic that it has minimal discomfort with no anesthesia for the patient, and I can get quick expeditious answers for them. What’s our range of using this? It’s there’s a lot.

If you stop here and said, well, I’m just gonna use the opposite seroscopy to evaluate abnormal uterine bleeding. You’d really be missing out on a lot of, advantages to this device as the name implies. And to see Advance, it has an advantage in moving forward. We can’t look at abnormal uterine bleeding.

Those that are having in the infertility world, they may have intercavitary structural lesions, recurrent miscarriages, etcetera that they can look at. We are identifying polyps and fibrin. We saw in some of the slides what the sensitivity specificity of this is. If you have a thickened endometrium, especially in a postmenopausal woman, you need to be able to look at that lining and see, is there some atypia? Because we know by that piston biopsy, unless you get the atypia back, unless you get some hyperplasia with some concern, you’re not done. That’s not an endpoint here.

We can transect some small septa. You can do polypectomies as long as they’re under two centimeters. I find it extraordinarily helpful in those, retained IUDs, with a string. We’ve all had that.

You place the IUD. It will then migrate a bit up into the cavity. You can’t see it. Very easy to do this in the office.

In the past, I’ve had to go to the operating room, an anesthetic, an expense to the patient. Now we can do it right there, in the office, and you’re also getting that presurgical planning. As I said, like we saw in the video, I keep going back to it, but you had that large polyp. Okay.

We’re ready. That means something that you know in your OR schedule, how much time you have to block and to get the right equipment there. So when we look at these prints, the first view that we get here on the left is, yeah, we’ve we possibly have some disease in the endometrial cavity. We have a false positive because when we do direct visualization over here on the right, a picture says a thousand words.

We see it. We see the tubal osteo that you can see in the left print. And then on the right print, you see the endometrial cavity. It’s normal.

So you had a false positive here with a sono histogram. Traditionally, what would occur, that patient would have gone on to the OR and incurred, more of an expense, more time, procedure, etcetera.

Here we once again look as well.

The top number two, we’re seeing the endometrial cavity. There is the potential that there is a lesion at the top of the fundus. Once again, doing direct visualization, the cavity is clean. The tubal ostia are visualized.

There’s no intracavitary lesions. Now let’s go down to number three. Once again, we see a lesion that we can see in the endometrial cavity. Okay. Now we have a true positive.

But this is to go along with saying we have true positives and we have false positives in this situation.

So what is the determining factor to say, breaks the tie here, use your direct visualization with hysteroscopy?

Once more, we look a little closer, and you might first, glance at this, say, well, I’m looking at the endometrial cavity.

Yeah, it has a little bit of irregularity to it. Is it actually abnormal or not? You can’t say that. You’re yes. You’re down from ten thousand feet as we talked about in the analogy. You’re looking a little bit closer inside that hanger. You’re like, yeah.

It could be normal.

Maybe it’s not. Wow. There’s that picture says a thousand words on the right. You have all that irregular growth. This, is concerning a blind piston pipette. Most likely, it’s not gonna sample this. This person needs directed biopsies.

This is a concerning finding.

Looking at our imaging again, look on our left. We’ve already, established transvaginal ultrasound. It’s great. Gives you that, you know, that distance look.

We I’m not advocating not doing it. It has its place. Okay. Looking at that picture, do I see a mass or not in the endometrial cavity?

I can’t be certain. Alright? We do a saline infused solar hystereography. Okay. We’re seeing a mass that is there, but you’re not done.

You have to take this a step further. Here’s your hysteroscope. Clearly see the polyp.

You could biopsy that in the office. If it was, small enough, you could resect it and be done.

So part of what I’m looking at here in my triage is, do I really wanna take that step with a a sono, saline infused sono histogram, or do I just wanna go from transvaginal ultrasound directly, to hysteroscopy. And in my practice, I find a greater benefit in that.

Here we have a postmenopausal female, and we can see in this video, that she has somewhat of a stenotic cervix, and we have to look at that to somehow get that to open. Well, with a hydrodissection placing some pressure here, as they’re moving through here, they’re getting that cervix to expand so they can see into the endometrial cavity. Once inside, you see your tulip osteo, you might see a little small amount of tissue over here. You might wanna biopsy with end of c.

You can biopsy that. You have the ability to that. Do you think that a blind piston by pipe l is gonna biopsy? No.

It’s not. This patient, again, she was sixty one. She’s postmenopausal.

They didn’t use any analgesia for that. They could hydrodilate using some saline as a technique, to get that cervix to open. They could see it. They saw, okay. We don’t have any real concerns. Or if they wanted to, they had the prerogative to go ahead and biopsy that area.

Lost IUD strains, we’ve all had them. They’re there.

And as you can see as this video runs, we’ve got our twenty seven year old, Milipras, g zero.

She wants to get pregnant, but we gotta get the IUD out. On the pass, we’re going to the operating room, exposing her to an anesthetic a day of her life was had to be taken out of recovery. Well, as you can see here, once we get that cavity, distended enough with the saline, the string itself can be easily retrieved. It’s very satisfying for the patient. Minimal discomfort with that. They avoid going to the operating room. IUD is removed.

You can also afterwards say, look into the cavity, reassure the patients. I see no abnormalities up in the uterine cavity. Get on your prenatal vitamins, do your preconception counseling, and encourage them on their, travels, for conception.

I had a case of a twenty four year old, g zero. She came in with placed an IUD. She was having some abnormal bleeding afterwards for about six weeks. She’s very frustrated. Sent her for an ultrasound, which showed that the IUD, as you can see in this picture here, unfortunately, I don’t have a video for this, but it’s in the lower uterine segment.

She didn’t wanna lose her IUD. She went through, she wasn’t compliant, with her oral contraceptive. She didn’t like other plans. We went in with the end to see, identified the tip of the IUD, and I was able to gently move it up into the fundus of the uterus, allowing her to maintain her IUD.

She, it was at a favorable price point. She was happy with the result. We didn’t have to look at getting a different form of contraception for her, and she was satisfied with the outcome. This example here is of a forty seven year old.

She was having severe heavy menstrual bleeding and a lot of pain or dysmenorrhea. So as you can see as this video runs, we had tried some medical therapy, but we could not get to the point of making, controlling her symptoms. So I wanted to better evaluate that endometrial cavity. And as you can see here, I’m finding normal endometrial tissue, to normal to a ostia.

I have a small projection of the endometrial cavity here in and of itself that is noncancerous. It could be biopsied if we wanted to.

We came out. I I was able to tell the patient, you know, for all intents and purposes, your endometrial cavity is normal.

These are our options. We can either go to endometrial ablation. We We can move forward with a history hysterectomy. She elected for hysterectomy at that point because she’d had medical therapy, exhausted that.

And, we were able to get to that thirty two days after her initial visit, which seems a long time, but some of that delay was, timing on her part as well. But we got a diagnosis very early, and then she was able to plan her surgery that worked best for her schedule. Our next patient here of mine was a forty nine year old. She’s having three month history of, worsening heavy bleeding.

So as you can see as this, video plays, she was actually had iron deficiency anemia. She had an elevated BMI. She was passing blood clots.

Even with her BMI, we could comfortably go in, look with the end to see.

We did an endometrial biopsy after she’d been on oral progesterone for seven days, getting her back in the office. The biopsy was unremarkable. There was not any precancerous changes.

She, at that point, desired to move forward, with a hysterectomy for definitive surgery. So fifteen days, after the initial diagnosis, we moved, to definitive surgery.

Here’s a, one of our last ones here, fifty year old, female, two to three year year history of heavy menstrual bleeding. As we can see in this video, she just had some benign proliferative endometrium. There’s no real that tissue that you see that is built up there just a little bit, it that’s not polyps. That’s a little bit of the the ospinder trying to get into the cavity, caused that tissue to to move up just a little bit. So three days from her new patient, entry into our clinic, we were able to visualize biopsy, her aligning, gave her some reassurance.

That’s as far as she wanted to take it at that point, and she was happy, with the outcome. And lastly, we have a thirty five year old having severe irregular heavy menstrual bleeding. You can see in this video, she does have, what appears to be just some benign, proliferative endometrium. I had a difficult time initially getting into the capacity internal cervical os.

But there again goes that hydro, distension or dilation of the cervix. If you just have your assistant pressing with some steady, saline, and gentle pressure, oftentimes, you’re going to get beyond that and you’re in the cavity. And then what I also wanna demonstrate here is, okay, now we’ve got a significant amount of air bubbles that have been propagated into the cavity. It’s really not an issue.

Take your in to see your device. Move it. As you see, I’m moving closer to the wall. I’m displacing some of the bubbles so I can get a look at the cavity.

There’s really you could aspirate if you wanted to. I didn’t find that that was necessary, but I was able to go to the area, displace, see the cavity, and what I felt have a global view of her endometrial cavity.

She was satisfied with those results. She said, well, she’s thirty five. But the bleeding that she was having was concerning enough for her that I felt like this was the next natural step.

So as we can see here by this slide, in the United States, doing diagnostic or therapeutic tissue, directed biopsies. We are reimbursed with this. It is my understanding in India as well, this is a, reimbursable procedure, and this is really something I would be interested in, during our question and answer to get your perspective on this and just see, how our two countries compare in, this area.

Summing up here, what are some of the advantage of this? We get instant endometrial imaging. There’s no guessing here. We’re not taking pictures of saying, I think there’s something here with transvaginal ultrasound.

Let’s go to saline impute. Yeah. There might be something there. No. We’re going right to it.

We’re going right to the tissue and seeing it. We see something that looks abnormal, we can biopsy it at that time. There’s no substitute for actually seeing tissue in its native state. You can actually visualize it.

Any of the color displays that you’re having, it means a difference. Any of us all of us that are experienced with this stenosis, we can visualize, look in there, and say, well, this is concerning to me.

This is not concerning. So that is an advantage.

Patients are experiencing very little discomfort. I’ve been doing this, three plus four years, and I lose track of time.

Initially, I was a little skeptical of how well are the patients going to, adapt to this.

I’m back in the old days of doing some rigid hysteroscopy in the office in residency thinking, oh my.

It was not a pleasant experience whatsoever. So, consequently, I put that aside. It’s like they’re going to the OR or or not.

So it took a little bit of convincing once I saw it. But once I did it, went through a series of patients, I was very pleased with that. It’s a it’s an efficient flow in your offices.

It is reducing that OR visits that I have so I can do, more of my advanced procedures during those days, but also treat the patients expeditiously in the, clinic. It’s not gonna take much time. Average length of procedure is really under three minutes.

It really shouldn’t take more than that, and there’s very low cost investment here. And depending on, your reimbursement model, it typically does reimburse well. But that’s, again, something that we can talk about later in our question and answer.

So in our final pathway here, as you see on the top, traditionally, multiple steps that we have to move along here. Now if we go down to the bottom here and we do our history and physical, let’s get that ultrasound. If you’re fortunate enough to have an ultrasound in your office, great.

If not, you’re coming back on your second visit. You can review the ultrasound result with your patient.

You’re gonna have a good idea anyway at that point. Okay. I think we’re gonna wanna do an office hysteroscope.

You’re preparing them with, possibly some nonsteroidal such as Motrin to come in. You talk about the ultrasound. You directly visualize. You get your biopsy as you need.

And then if you need to take this to the next level as going to the OR, you can. Or if you don’t find any structural abnormalities at that time, you can go into more of a medical approach to treating their problems. So you have shortened that curve. You’ve shortened that time period dramatically.

Telemedicine, it’s here. It is here.

I work out into some rural clinics, and we’ve looked at that. I’m like, how is telemedicine really going to fit in a gynecology for obvious reasons? You know, we look about the exam part.

But we have to be very, sensitive to the fact that we’re gonna have a fair amount of patients who are in that menopausal age that are getting up there with multiple health issues. If we can do things in remote areas, talk to them, get their history, get some assessment of where they’re at, once we bring them back into the clinic, we can very efficiently, quickly go to our hysteroscope as we need to minimize their time that they need to be in a hospital clinic sys setting and actually get answers for them, triage appropriately.

Bottom line, get them the care that they need. So doctor Goldstein, who is, world renowned, and he has forgotten more about ultrasound than I will ever know. And most of us, he developed a lot of our approaches of of transvaginal sonal, saline infused sonal histogram. He looks at this. He says, there’s this is a new approach in gynecologic, diagnosis. It’s transformative.

It’s helping us in our management of our patients with a variety of disorders. This is huge. This is a a an individual, an extraordinarily talented individual, spent a lot of his work that can see the merits as well of taking this to the next level.

In conclusion, we’ve got direct visualization of that endometrial cavity. It’s highly accurate. You looked at some of the data that we showed you. We showed you sensitivities and specificities.

When it’s there, can we see it? When it’s not there, can we say it’s not there? There are some shortcomings of transvaginal ultrasound, certainly, and saline infused somnolist urography. So it exists.

We’re decreasing our treatment time. We can get to an answer quicker and provide relief to our patients and in a in a manner that they, they deserve.

We’re giving better care with this. We certainly are. We are now able to visualize, provide them with answers and treatments in a way that we often couldn’t in the past. And it’s actually, selfishly, it is maximizing as physicians our time.

We can see what we need to see in the office. We can take to the OR what we need to, and we can manage our spectrum of patients better. And it’s cost effective. It’s cost effective for the patients.

It’s cost effective for the practice. It is cost effective for health care as a whole. So with that, I do appreciate, your attentiveness to this, and I am really excited about spending some time here with questions and answers.

Thank you. Thank you, doctor McCoy, for presenting tonight and and experiencing your endoc with this audience tonight.

We are going to open it up now to our q and a session. There’s a couple questions that came in during the presentation from our audience. Let’s begin.

What is the most important factor in considering EndoC Advance in your opinion?

In my opinion, Christine, when you get to the point of working up your abnormal uterine bleeding, You have to stop and say, what is my, likelihood of a malignancy?

How much do I need to know? Is there hyperplasia, of the endometrium, etcetera? Based on that, I feel like there’s just really no other substitute. We need to have some tissue as as I’ve been told by oncologists before, tissue is a issue, but we need targeted tissue. We need to be able to see what we’re going after, and Endosy allows me to do that. So that’s how I have incorporated, this device into my practice, to make that flow, go more smoothly. And at the end of the day, I have the sense that I provided the best care for my patients.

Great. How do you explain this procedure to your patients?

Well, what I explain to them is, you know, as the gynecologist listening here, I think they can appreciate that. You know, our patients are coming in, they’re having a problem. They’re having the bleeding. And then my approach to them is, okay. We have a couple methods here of better evaluating what your condition is. We most in most instances, we need some tissue to ensure that you don’t have cancer and, depending on the age, I I say that to them, to emphasize the need of why we need to be invasive here, and then I give them the option. I first tell them, you know, we can certainly do this comfortably in the office.

This will not be a prolonged procedure. It is going to allow us to be diagnostic and, in some cases, therapeutic. We can do that without a major anesthetic, very minimal downtime for you. Or if you’re not comfortable with that, and you’re gonna have a sense, most of us will with the patient’s threshold for pain, etcetera, we can schedule this at the hospital side. And then, you know, at the very end, it’s like, well, it certainly is going to be, more economical for you to be in the office as long as you’re comfortable with that.

If you’re not, certainly, we can do it in the OR. Just understanding that there is gonna be an a little bit additional significant additional cost associated with that, and I let the patient then decide in what venue and what environment they’re most comfortable with.

Thank you. When speaking about pain and talking about the procedure to your patients, when do you choose to premedicate a patient before using EndoSee Advance, and what do you use?

Right. I’m of the the class that is, you know, treated with endometrial ablations in the office, the hydrothermal, the NovaSure, using significant, injury to the endometrium. In those cases, we would use narcotics, I’m Toradol, even some Valium to relax them. What I’ve been really pleased with with Endocee and this procedure, you don’t need that.

After you’ve explained the procedure to the patient, I tell them I would like for you to take eight hundred milligrams of ibuprofen or a type of nonsteroidal they’re comfortable with two to three hours prior to presenting to the office, for their procedure as long as they don’t have any contraindications to that.

That has, historically, in my practice, been more than adequate to, provide the analgesia aside from a paracervical block that they need.

Thank you. What do you recommend in a case where the patient’s cervix will not dilate, and how often does this occur?

That, fortunately, is not very often. You would think, when doing these procedures, my goodness, I’m gonna I’m gonna run into more and more circumstances with that. In the premenopausal female, in those instances where you’re motivated to get this procedure done in into the office, using misoprostol, usually two hundred micrograms the night before, would tell you, you know, not to that’s gonna limit some of your premedication with your ibuprofen, but give them that, and I’ve been successful with that. That’s allowed me to navigate, the cervix.

I can count on one hand, over the years the amount of times that I’ve had to go to that. I’ve had a sense by looking at their cervix, ahead of time, and there will be a few instances in spite of everything that you do. You’re not gonna be able to comfortably get into the endometrial cavity in the office, but I can tell you that it’s gonna be a very low percentage.

Thank you. Is it necessary to use a lubricant when inserting the cannula?

I personally like to. I started using, lubricants to dilate the cervix years ago in the operating room, prior to hysteroscopy, now with uterine manipulators, prior to hysterectomy. I just think it makes the procedure so much easier. It is much smoother per se, and I have, used that and taken that into the office.

It does not interfere at all with your visualization of the endometrial cavity, and I certainly believe it assists you, with navigating the lower uterine segment.

That’s great. What therapeutic procedures procedures are you comfortable performing in the office with Endocee Advance?

Well, first and foremost, I think it’s a beautiful device for retrieving foreign bodies. As we know, the IUD string, that infamous IUD string that we, know that when we trim it after we placed it, for whatever reason, a fair percentage of those are going to find their way, into the uterus that you’re not gonna be able to identify. So, the fenestrated grasper that comes, adaptable to, the NSC Advanced, I find that very helpful. I will biopsy, some polyps if they’re, you know, if I’m looking at a couple millimeters, if I can retrieve that, but again, my goal of going into there in the office is either I’m going to remove a foreign body or, b, on the other side, I’m trying to get some tissue.

I’m trying to target the endometrium. I’m trying to see what my surroundings are, what I need to navigate so that I can prepare later. Do I need to then take them to the OR to do a more aggressive therapeutic, procedure, or or are they gonna be in that sixty percent that don’t have a structural, anomaly that they can then avoid any other additional, procedures in office or in the OR?

And when talking about removing a polyp, what size polyp are you comfortable removing in the office?

I will go a couple millimeters, to to you know, I you’re getting up to half a a centimeter. I’m gonna stop at that point, with issues with bleeding, etcetera.

I think the patient, if it does not comfortably remove with that, I’ll probably, go ahead and go to the OR afterwards with that, but then I’m able to prepare for that.

And when speaking about bleeding, how do you manage visualization if there is bleeding during the procedure?

Well, first and foremost, I’ll have my assistant who is, managing my fluid flow, and sometimes the questions come up, you know, how are you gonna manage your your fluid flow? I have used a pressure bag, and then really getting into the exact pressure with that, it’s more of a sense of you’re gonna be able to tell as the, fluid is instilling in the uterus how much you want to use. But now, it was very easy to train the office staff. My nurse is very adept at what I’m looking for, so I have her with a fifty cc syringe with saline.

If I’m having a little bit more bleeding than I want, I’ll have her increase the amount of flow with that, and then I will go, to the, endometrial cavity wall and then start to bring myself back off of that. That allows me to, hydro distend more, but also your focal length, you can get very close with the Endosy Advanced device. You can get right on that wall. So if you’re looking from ten thousand feet, get up closer, get on the ground, get up next to what you’re looking at, use your, irrigation at that point, get your surroundings, and then move about that way. You’re introducing such a small amount of trauma with the EndoSee Advance, you’ll be surprised how quickly that, blood in the field actually resolves.

Thank you. How do you schedule your patient appointments when planning for multiple procedures back to back?

What we do is I’m fortunate. I have three exam rooms in my office, and then we have a procedure room.

So on my day in the clinic, what I will do is I’ll continue to schedule my routine patients anywhere from ten to fifteen minutes, and then we block time over in the procedure room at thirty minute blocks.

So what I will do is I will see, you know, per se in an hour block, start with my patient in the procedure room. I’ll go in. My nurse has already explained the procedure. I’ll go over the procedure once again with them, place the paracervical block, and then leave the room. I like to let that set for about ten to fifteen minutes. I’ll then go see, the other patients in the three rooms.

Once I’ve completed that, we’re back. The patient is comfortable. I know when I go to the dentist, I don’t want them to put, inject, around a tooth and then go right to, the repair. I’m like, please just go see some other patients.

Give me some time. I know that this needs a little bit of time to set up, probably not as long as I feel it needs to, but the patient’s reassured by that as well. Then I come back in, do the procedure, which shouldn’t last, on average more than one to two minutes. We’re finished.

The patient is able to dress. I can go out, see another patient, come back in, talk about the results. We can actually move them to one of my other three rooms, while the staff is cleaning the procedure room, and then we can start that process over. So it’s extraordinarily, efficient.

It it actually doesn’t disrupt the flow of the office at all. So I don’t look at, oh, this is procedure day. I’m gonna do some indices. Everything else stops. No. We keep everything flowing, in an efficient manner.

That’s great to hear. How many procedures did it take you to work up the learning curve with Endocid Advance?

Well, that’s a very good question. And I began to feel comfortable with the Endocid after ten procedures in that ballpark because, you know, we’re all accustomed to using or most of us are, the the rigid hysteroscopes in the OR.

We have a set routine of how we’re dilating the cervix, how we’re maneuvering it, etcetera.

So in a very short amount of time, my, Cooper, surgical or, actually, Cooper staff with NDC, they were extraordinarily helpful. They were there, through the procedures until I was like, okay, guys. Enough. I I really don’t need you here anymore.

I’m feeling comfortable at this point, and we went through that flow of, okay. What are you what am I gonna do? I’m I’m having problems getting into that lower urine segment. Okay.

Try to do a little bit more fluid distension.

May need to try to use the, you know, os finder to get a little bit, more of an opening. May need to use a uterine sound, which I probably only use a uterine sound once every twenty five times for the procedures.

So at that ten, procedure mark, my thoughts were, Hey, you know, I’m ninety percent of getting into that cavity.

I’m feeling pretty good about it. This is something that we can offer.

But not what I really wanna encourage those that are first starting it, if it gets to be a negative experience when you’re first training in the office with the patient, just stop. It’s okay.

Get to where what you did.

Talk with your Cooper rep. What could I have maybe done differently?

How can I navigate this differently next time? Give it a fair sampling. Don’t just do one procedure because it may be that one that has a stenotic in the cervix. You may be fortunate to have the one that is very dilated as, you know, as a great patient three or four times. You you’re not you’re gonna be fine then when you find that challenge, but give yourself about ten.

I think at that point, you can have a real good sample size, and I think you’re gonna be proficient, at it at that point and can decide if that’s gonna be, part of your practice.

Great.

You touched upon training your office staff. How easy was it to train your office staff on the use of Endocee Advance?

Unbelievably easy. Unbelievably. You know, the staff came in, did a nice in service on, you know, this is the kit. The kits come, they’re very self explanatory, opening them up with the drapes, with the Betadine, etcetera, explaining, do you wanna have you know, some providers will use an IV bag, pressure bag. That’s available. Here’s your tubing. It can go with that, or you can simply do it with a syringe.

The staff within a couple procedures, they had it. Their learning curve was much, much shorter than mine.

Great. Has Endoc Advance allowed you to provide better care and achieve higher patient satisfaction?

I really think it does. And in this day and age, a couple things.

We we’ve all been facing the COVID, situation out there.

People are very sensitive to the fact that, you know, we don’t always wanna go to the OR or to the hospital for one. We’re going to be more exposed.

Number two, patients have been extraordinarily pleased with they come in, we talk to them about their condition, and it’s, okay, I want to get an ultrasound and based on your age, on your symptoms, I want you to come back and would like to do an office hysteroscope. I explained just as earlier why we’re gonna do that. So on their second visit, they’re coming in, at a much reduced cost. They’re getting it done sixty plus percent of the time just there in the office within just a couple of visits.

If those patients that have a structural, issue that need to go on to the OR, we’re at the third visit able to schedule that. So they have the patients realize this is more efficient.

They realize that when you take, extra caution to really evaluate their condition and feel comfortable with what you’re treating objectively, they appreciate that, they appreciate the cost savings with that, and a lot of these women, they are very active, they have jobs, they have families, It has minimal downtime for them, so it is this entire package, that women are extraordinarily adept at saying, okay.

This this has value, and they tell their friends and others, the staff. My staff sees this as well.

They are, you know, very they work very hard to schedule these procedures because they realize, the improvement and impact that it has on lives. So it has been an extraordinarily positive addition to my practice.

Thank you. And lastly, do you have any final thoughts that you would like to share with the audience tonight?

Yeah. I I would really encourage you, You know, it’s not a big step outside of the box.

I’ve been as you can tell by my gray hair, I’ve been doing this a long time. I graduated, from medical school in nineteen ninety two. We were then at that point doing X rays, just flat plates. CT scans were not coming into their own.

Ultrasound was okay, but it’s not where it is today. Now we have CT scans, we have MRIs, we have ways that we can actually get inside the body. We can look as if we’re right there, as if we’re doing surgery. So why would we want to do anything blindly, in the uterine cavity?

We all know that endometrial cancer is the number one genital cancers for females. It’s our job to identify those women at risk. It’s our job to help them with that condition, and what better way than to actually see what you’re looking at? This is not a blind condition to treat anymore.

We now that would be the same as saying, well, I feel like you have abdominal pain. I’m gonna just take a flat plate of your abdomen.

Well, it might be an appendix. Let’s go in there and take that out. No. We’re gonna get the CT scan.

We’re gonna look. Everybody would just look at you like, are you insane? Why are you not doing a CT scan for this patient? Kind of flows here.

We need to kind of get in the habit of, okay, now we have a device in the office.

We don’t have to run to the OR. We can evaluate these patients. Let’s do what’s right for them and get the best answers.

Thank you. Thank you again, doctor McCoy, for presenting tonight and sharing your Endocee ADVANCE experiences.

This was very insightful, and I have learned a lot this evening.

This will conclude our program tonight. And as a reminder, Cooper Surgical will be following up with any questions that we were not able to answer in tonight’s program.

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