Direct Visualization Can Transform Your Practice – with Dr. Risa Kagan

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Good evening, everyone. Hello. My name is Kelly McKeon. I am your event manager and will assist in running the virtual presentation this evening. I’d like to welcome you all, and thank you very much for your participation.

First, I’ll go over a few notes on how this presentation will run. We have our presentation tonight with questions and answers to follow. Please keep in mind that all participants will be on mute for the duration of the meeting. However, you’ll have the ability to submit any questions through the q and a feature during the entire presentation, which you’ll see at the bottom of your screen. Doctor Kagan will participate in a q and a session upon conclusion of the presentation.

For any questions that we do not get to this evening, you will receive a response from Cooper Surgical or the speaker following the meeting. I’d now like to introduce our speaker for this evening, doctor Risa Kagan. Doctor Kagan is the clinical professor in the department of obstetrics, gynecology, and reproductive sciences at UCSF and gynecologist at Sutter East Bay Medical Foundation in Berkeley, California. I’ll now turn this over to doctor Kagan to begin the presentation. Doctor Kagan, you now have presenter privileges.

Well, thank you for joining me this evening, and I’m thrilled to be able to teach you or present to you, about the EndoSee Advance, which has totally transformed my practice and my workup of abnormal bleeding in my patients that I would like to teach you why I think this is really an advantageous new technology or new procedure that can really help you and plan for the best care for your patients. So we’re gonna talk about the direct visualization that can really transform your practice like it has mine and my care of women with abnormal bleeding.

These are my disclosures, and yes, I am a consultant and a speaker for Cooper Surgical.

But I’ll show you when we look at the original version of this how I was one of your earlier adopters. I used the earlier version, and now I’m thrilled with this advanced EndoSee that has many more advantages than the earlier one.

So doctor Ted Anderson, many of you may know who he is. He’s really one of the godfathers of, hysteroscopy, very involved, obviously, with the AGL.

And this is a direct quote from his, a statement that he made about the ability to look inside the uterus to diagnose anatomic abnormalities that affect reproductive health and underlying gynecologic disorders is an invaluable tool for the modern gynecologist.

And going on, as you can see, so it’s a doing it in the office is not only offers the advantage, convenience for our patients. And just think about it. Many of our women are busy moms or they’re busy working women, and it’s so convenient, it’s economical, but it also helps women plan their life in reference to a procedure that they might need and also, of course, helps cut health care costs. Before I get into abnormal bleeding and discussion of the evaluation of abnormal bleeding, I just wanna share with all of you something that really triggered this, as being such a great procedure for me in my practice.

Every day, day in and day out, our colleagues, someone comes in with a complaint in their ear, in their mouth, they take out the otoscope.

You have a GI bleed, upper or lower, there’s no way that people do indirect imaging. Our GI colleagues, they’re always doing an endoscopy, a colonoscopy.

I think that the time has come for although ultrasound is great and saline sauna is great for helping us, I’m not, you know, disbanding using them, But to have direct visualization in an easy way to evaluate why your patient is having abnormal bleeding is key, and most societies totally endorse this approach.

So let’s talk about abnormal bleeding just briefly. It is absolutely the most common thing we all see day in and day out in reproductive age women and midlife and beyond.

It’s been shown over and over again that about thirty percent thirty three percent of all gynecologic outpatient visits are due to abnormal bleeding. And as a menopause practitioner, NAM certified, I will tell you that greater than seventy percent of the patients that I see in midlife and beyond, okay, are coming in with complaints of abnormal bleeding, whether it’s heavier bleeding, spotting in between periods, postmenopausal bleeding. It’s a common day in and day out reason why women seek care. Now the palm coin classification has definitely helped us in trying to figure out why these women are bleeding.

And I think it’s an excellent way of thinking about it. But just keep in mind is that the cause for abnormal bleeding in these women, thirty five and older, have been shown to be about twenty to forty percent structural abnormalities, whether they be polyps, adenomyosis, fibroids, and unfortunately, at times, hyperplasia and cancer. And if you have fibroids, you have no idea yet. Ultrasounds can show something.

But really, is it a submucous myoma? How big is that fibroid? Is it in the cavity? How much is it in the cavity?

And then, of course, once one rules out that as a possibility, you have about sixty to eighty percent of patients that have nonstructural problems that we can then work on to keep treating these patients hormonally, adjusting, even OCPs, without knowing if they have a structural problem is often a waste of time. And many patients will come in and say, wow. You know, for a year now, I’ve been trying this and trying that and trying this. Finally, I did a procedure where I looked in the uterus, saw the problem, dealt with the problem, and they are treated.

So this is why, I think it’s important for one to understand the proper evaluation of abnormal bleeding. Pollabs are very common. I think we all see polyps. But how do we evaluate those polyps?

They are diagnosed in about twenty to forty percent of women with abnormal bleeding. This is one of the key reasons for structural abnormality, and these are beautiful pictures as you can see. But for certain, the blinded endometrial biopsy in and out has a very high false negative rate for making a diagnosis of a polyp. And polyps with abnormal bleeding are often a common symptom or sign of endometrial cancer. When you look at data, it says that the prevalence of polyps with malignancy in women with abnormal bleeding, about twenty three, twenty four percent of those, they have hyperplasia.

So you get rid of the polyp, you have a reason why they have abnormal bleeding, they have hyperplasia, it’s important to know that. But even about one and a half percent are have malignancy.

So all polyps that are bleeding must be removed. They must be evaluated.

Now the asymptomatic polyp is a different story that’s beyond the scope of our discussion here tonight. But for certain, for women who have polyps that are bleeding, they must be evaluated and removed, and a blinded biopsy is not gonna pick up that polyp. There’s a complete big polyp in this patient’s uterus. So that patient, if it’s not a small polyp, that that polyp needs to go to the OR. But you can make plans. You can plan for what’s going to happen, how much time they need off, and you can plan for your equipment in the operating room. So this is one of the advantages to doing this right in the office.

Fibroids may be a source of bleeding. They often are a source of bleeding. Look at this picture, large fibroid. Well, fibroids occur in about twenty five to forty percent of women of reproductive age with a lifetime risk said to be over sixty percent.

But there’s fibroids and there’s fibroids. And I think we all know that those fibroids that are purely intramural often don’t cause abnormal bleeding. But those that come to close to the cavity or, you know, in the cavity, some mucosal, are diagnosed in about five to eleven percent of women presenting with abnormal bleeding. These are the women that can really hemorrhage and are of major consequence to their, you know, well-being.

A blinded endometrial biopsy has been shown, again, to have a false negative rate, high eighty seven to ninety eight percent in submucous, in submucosal fibroid diagnosis.

There’s no way that a blinded biopsy, unless you maybe can feel it while you’re doing the biopsy, diagnosis the submucous fibroid.

Fibroids really that are bleeding can interfere with one’s quality of life, their pain, pressure, infertility, and sexuality is an important other important problem related to this abnormal bleeding due to fibroids.

So they’re not inconsequential.

And of course, the absolute most important reason why we evaluate abnormal bleeding in women is to rule out hyperplasia, premalignant lesion, and amalignancy, which could always be the source of bleeding, especially in women who are in midlife and beyond.

Endometrial hyperplasia is diagnosed in about three and a half to four percent of women who present with abnormal bleeding. And there are some studies that have shown up to a seventy five percent false negative rate with the blinded biopsy in and out for diagnosing hyperplasia.

Look at this picture over here. I mean, you even want by doing more endoces or, you know, hysteroscopies in general, you get to really correlate, what something looks like as a diagnosis as well. It’s it’s a learning procedure.

But we all know that the risk of progression to cancer over twenty years from complex hyperplasia with no atypia is about less than five percent. So we treat those. You know, complex simple hyperplasia, we often treat medically. But when you are dealing with atypical hyperplasia, you’re on the verge of, you know, developing cancer that really needs to be addressed in a very different way. In atypical hyperplasia, the risk to progression to cancer over twenty years is about, you know, fifteen to twenty eight percent. And so it’s imperative when we do our evaluation for abnormal bleeding that we rule out the most serious of conditions, which is atypical hyperplasia and malignancy.

So why do we do biopsies?

I mean, I taught I teach medical students, I teach residents, house staff, I teach my partners, my younger partners.

You know, it’s easy. It’s like in and out, you do that little pipel. Where did that come from? Where was the mainstay of, you know, why are we doing that?

And nobody thinks about, well, I need to go on to doing direct visualization. I have to have another answer for what’s going on. Well, it goes way back to the early nineties, and I remember when this, you know, this article came out in the literature, and it was, published by our colleague, Tom Stovall, in the early nineties. He did a study.

He studied forty women, and they were all known to have cancer. He did a week before their hysterectomy, a blinded little papel biopsy.

And what came out in thirty nine out of forty of those women was cancer. So then what happened? The the the procedure flew. I mean, everybody started saying, oh, in and out, little papel biopsies.

This was the way to go. And that was really it. From then on, everybody started doing it. Well, guess what?

There have been numerous studies that have shown over and over again that if that pathology of that malignancy doesn’t occupy more than fifty percent of the cavity, you’re gonna miss it completely.

So and then, of course, you are definitely gonna miss these structural problems.

So office hysteroscopy has been shown again and again as well as regular hysteroscopy, but that costs a lot of time and money and time out from life. But if you can do an office hysteroscopy, a direct visualization, it’s absolutely more accurate than a biopsy alone, both for polyps, myomas, and hyperplasia.

And in this one study, as you can see, looking at blinded biopsies using a little pipel versus hysteroscopy for diagnosing polyps, there’s no question that hysteroscopy is going to make a big difference rather than a blinded biopsy. Same thing goes for a structural problem like myomas, submucous myomas. The sensitivity is extremely low in this study, thirteen percent versus a hundred percent with looking, with a hysteroscope.

And then for diagnosing hyperplasia, well, you go up with your little pipel. You might be lucky if you get it. And if it’s global or it’s over fifty percent of the cavity, then sure, you’re gonna get some tissue. But again and again, looking at it is definitely a better beneficial to the patient and for your treatment of that patient.

I always say doing that biopsy, if it comes out positive, meaning you have hyperplasia or cancer, well, that’s that’s diagnostic.

But if it’s negative, meaning you get proliferative endometrium, you get nothing, you can’t stop there when somebody’s having abnormal bleeding. You must go on to something else. Well, why not find out right away?

Now this is a guideline put out by ACOG. Many people have seen it over and over again, and the one thing I’ll say here is this is from two thousand twelve, but it was re endorsed, and reconfirmed, as we say, or reaffirmed by ACOG in two thousand sixteen.

Nothing has changed. The ACOG guidelines do confirm that the biopsies may be insufficient.

And they say that the primary role of endometrial sampling in patients with abnormal bleeding is determine whether there’s cancer or hyperplasia, and that’s it. The endometrial biopsy is accurate in diagnosing cancer when you have a good specimen, an accurate, adequate specimen.

And that means that the hyperplasia or the cancer is global, And that somehow that message didn’t go through after the original Stovall study was, was performed.

A positive result is more accurate for ruling in a disease than a negative result for ruling it out. So, therefore, these tests are only an endpoint when they like, so when you do a biopsy in the office, don’t send the patient walking because you haven’t figured out her abnormal bleeding unless she really has atypical complex hyperplasia or cancer.

And ACOG guidelines do support using some sort of diagnostic advanced imaging. Sona hysterography, some call it saline sonogram, SIS, we call it in clinical trials, you know, is definitely superior to a plain transvaginal ultrasound and the detection of the intracavitary lesions. Do your ultrasound, you put in a little bit of fluid, but then again, this is indirect imaging. So So you better be really good with your ultrasound and doing your saline saunas, but it definitely works for many people.

Hysteroscopy may be another alternative that is performed in an office setting or even in an operating room. But when you bring the patient to the OR, it’s more expensive to the health care system and to that patient. So doing it in an office setting where the patient is right there, they don’t have to take off of work, you’re not using very expensive equipment, can actually offer faster recovery, time less time off of work, and it’s more economical, and you have your diagnosis to plan for what you might need to do in the OR.

And in meta analysis that evaluated the diagnostic accuracy of hysteroscopy, it had an overall success rate of about the high nineties. No surprise. You’re doing direct visualization like all our colleagues do when they do colonoscopies or endoscopies and other kinds of oscopies.

So, I I implore you to reread this practice bulletin as a great review of this whole topic.

So what we have here is actually systemic review of imaging studies by Maho and LaCroix. My French is not very good. But the objective was to evaluate the accuracy of saline infusion, sinohistography in comparison with transvaginal ultrasound for diagnosing structural problems that I’ve been talking about. Polyps, some mucus fibroids, and women who have abnormal bleeding. They included twenty five studies, and what was found was the saline sonogram was superior to plain transvaginal ultrasound with a pooled sensitivity and specificity of ninety two and eighty nine percent compared to the sixty four and ninety percent respectively with a p value of less than point zero zero one, so highly significant.

Well, no surprise. If you put in a little bit of fluid, then you might be able to see the submucous fibroid or a real intracavitary fibroid. You might really be able to see the polyp and that really regular transvaginal ultrasound may not see.

The saline ultrasound was also compared with hysteroscopy in seven studies that had similar sensitivity but inferior specificity of about ninety three and eighty three percent compared to the ninety five and ninety ninety five percent, ninety percent. And this was also highly significant.

Of course, because you’re directly visualizing as opposed to putting in fluid and then again being using imaging, which is a non direct vision you know, visualization.

Quote, transvaginal ultrasound lacks the sensitivity to be used all by itself.

Well, we all know that.

But hysteroscopy provides that direct visualization of the cavity, and then it combines it with histopathologic evaluation, which is really the criteria that standard of practice that really should be used in the diagnosis of abnormal bleeding and intrauterine abnormalities.

This comes right from this, meta analysis.

So here is another study, a prospective comparison of looking at the diagnostic performance of all these three modalities.

And what this was was a hundred and five patients with premenopausal abnormal bleeding or postmenopausal abnormal bleeding or even infertility.

And looking at which is the best way for detecting endometrial lesions in symptomatic women. And as you can see, to pick up any abnormality, you know, they’re all pretty sensitive, but gets better as you put fluid in and then, of course, doing a direct look is even the best. But when you look at the specificity, you really see a difference here. What you see clearly is the direct visualization is, you know, ninety two percent as opposed to sixty and fifty six percent.

So that’s for any abnormality. Now when you look at polyps and fibroids, again, across the board, it gets better. And, you know, an ultrasound is better than nothing. Sticking in a little fluid and doing an ultrasound is good, but there’s nothing better than direct visualization both in making any of these diagnoses.

So why is why are we seeing this more? Why are people you know, I’m in a very large group and, you know, all different ages of people being trained, at various academic institutions around the country.

And then I teach residents and they’re busy in the clinic, Patient comes in with abnormal bleeding. Everybody just wants to go in and do a biopsy.

I don’t understand, but I do understand that it’s easier to just go in and do a biopsy to get you know, hoping that maybe you’ll get something, but you just can’t stop there.

So here’s why we’re not seeing it, because not everybody has office hysteroscopy that’s easily done. You have to take off time from work. The patient basically has to go either to the OR or the outpatient department. It’s just, you know, not a patient friendly way of doing it.

And for people who do it in the office now, that’s fine. But honestly, even then, it’s a lot of equipments, it costs a lot of money, patients may still need some kind of analgesia, and it’s also costly. So traditional hysteroscopy, whether as an outpatient or an inpatient, is a procedure, and and it takes time to orchestrate that procedure. It’s not done necessarily at the time in which you’re seeing the patient for the abnormal bleeding.

And these are beautiful pictures here, again, reinforcing direct visualization.

But it costs a lot of money and time and effort. And for these working women, this is not necessarily that wants to be done. So it’s easier to just do a biopsy and at least reassure the patient that they don’t have hyperplasia or cancer. But the story cannot stop there.

So here’s our traditional pathway that we’ve always used. Patient comes in with abnormal bleeding. You do a history, physical, sometimes labs. For sure, you know, one does a transvaginal ultrasound.

You might do it in your office if you’re good at it. Many women and many practitioners don’t have them in their office. So then you write an order for an ultrasound. They have to go to the radiology suite.

They end up with an ultrasound done elsewhere. That’s another cost. Some people would do the endometrial biopsy right then and there. Others wait till the ultrasound comes back depending on the age of the patient, depending on where they are in their cycle.

At some point, they may end up getting an endometrial biopsy. Then you go on and say, okay. I think you need some fluid in there. So then people have them come back.

They have another room. Most people do saline sonograms in a special room. If they have an ultrasound, they have a little room. They don’t necessarily bring it.

They make, you know, any every exam room, and they have come in for another saline sonogram. And then you make a decision about whether the patient needs a procedure or not. So it takes time to do this workup, and the woman doesn’t even have an answer many of time by the time you see them for abnormal bleeding. You make a plan.

They go to the OR. They might have a diagnostic hysteroscopy in the OR even if you did it in the office. You know, basically, it’s another day and time, for sure. Then you make a decision about treatment.

It takes time. This is what people do in everyday practice now. I think there’s a better way, though, that I have learned for me in my practice.

Well, this is a study that actually looks at not only the the benefit for the patient and the practitioner, but actually looks at the cost cost effectiveness of using office hysteroscopy for abnormal bleeding. So the overall objective was to determine whether office hysteroscopy decreases the need for hysteroscopy performed in the OR and also the financial implications. It took a hundred and thirty patients with abnormal bleeding. It was in an academic center.

And what you see is that forty two percent of them needed to go to the OR, but fifty eight percent avoid it. And if you look at the fees on the the table here, the physician’s fee is standard, whether they’re gonna do it in the office or whether they’re gonna do it in the operating room. But really what we’re saving is an anesthesia fee, and in many institutions, they make even if it’s IV sedation, they make you have an anesthesiologist present. There’s a hospital fee.

And whether it’s an outpatient surgery or in hospital surgery, day surgery, there’s a huge cost.

So there’s no question that it is economically a better situation to try to stay in the office first. And I can tell you that avoiding the OR in this study may save, you know, over three thousand five hundred dollars per patient, sometimes more. And also in using this little procedure, most people have minimal to no pain. It’s a very flexible hysteroscope for doing office hysteroscopy.

And then when needed, it prepares us to be able to plan for what equipment and what we need in the OR, and the patient can plan as well for their life. So years ago, I personally had a rigid, one of the earlier, we’re using Hiscon in a rigid scope in my office just for diagnosis. We had a special room. The equipment broke down. We ended up using a lot of, fluid medium that would get stuck. We had to clean the equipment. It got to be, burdensome.

And, when I ended up joining a big foundation, it took years before I could even find a way to do, office hysteroscopy, until I started using EndoC, which has changed my life and my patients’ lives for planning if they really need to do a hospital procedure. So for instance, this week alone, I did two EndoCs on women that on ultrasound had thick endometrial linings with cystic change. One had a history of using tamoxifen years ago, and one was currently on tamoxifen.

And lo and behold, those women by somebody else was they would have been taken to the OR. Years ago, I would have taken them to the OR. So these two EndoC procedures for me kept them out of the OR, and they had subendometrial typical CIRM cystic, you know, change. But their endometrium themselves were completely atrophic, and there was no evidence of any abnormality, polyps, nothing.

So I saved those two women a cost like this study did from taking not only off for the hospital fee, but their days of work where they have to be in the hospital for the whole time and take a day off.

So now I’d like to move on and actually introduce you to Cooper Surgical, which many of you know. I will tell you that until I started doing endo sees, I didn’t understand how half the equipment we use in our office are from Cooper. The pessaries, a lot of different devices, you know, our leaps, and I just never, you know, associated that with Cooper. But this procedure in itself is clearly a visionary, and it’s, user friendly.

And I think it’s going to help us for sure. It’ll help you. It’s helped me, and it’s gonna help. And my patients are just love it because they love seeing the pictures afterwards as well.

Okay. So let me get to the EndoSee specifically, and this is called the EndoSee Advanced. This is what we’re using, currently.

The original EndoSee came out in two thousand fourteen.

I learned about it, through my colleague, Stephen Goldstein, at an ACOG meeting. I quickly, found out about it, tried to bring it to our health care system. It took a little while to get through the red tape. But as soon as I could, we did, because it was the easiest, procedure device to adapt to our practice that now I have also brought it to our residents and, have really, been able to incorporate evidence based evaluation of abnormal bleeding in a economical way, a safe way, an easy way, and really patient friendly.

My patients are so happy when I describe to them. They go online and read about it, and they see what we’re gonna be able to do rather than just a little quick biopsy and then also or take them to the OR for a diagnostic evaluation that may turn out to find nothing. So, I’m gonna introduce you now to the current model that came out just this last year called the NOC Advance. It’s really state of the art direct visualization.

It’s been cleared by the FDA for both hysteroscopy and cystoscopy, and this advanced model now has a working channel.

The company listened to a bunch of us, who were using the other version saying, hey. Listen. You gotta really work on go to your engineers and figure out a way to have a working channel. It’s a, new camera, light source. Every time at this I show this to the patient when I take out this instrument.

This little black tip has a beautiful camera.

The actual cannula, I also show them and say this is about the size of the pipella that you might have had or you will have.

It, the rounded tip measures four point three millimeters.

It’s single use, and it really is the perfect stiffness now. Earlier versions were too flexible.

This one now really goes in quite easily, but there’s a easy docking station, which then really directly transfer the images into Epic, which I have. It’s very easy for charging.

We have beautiful pictures right in front of you as you’re doing it. It’s lightweight, ergonomically, handheld design. This is a really much better, handle than the older version for moving it around and and really looking at the osteo, looking around polyps and fibroids, and I just like the fact that, the newer version is just so much better and user friendly. Now there’s also this little working channel, which we can put in little scissors, a little grasping forceps. It’s advanced because it is an advancement over the original NOC.

People use it for abnormal bleeding, menstrual disorders, pelvic pain. I will tell you, though, as much as I talk about point of care, meaning right then and there, we can do it if a patient comes in for abnormal bleeding, you know, that can happen more for postmenopausal women because it’s best to do this on a reproductive age women woman just like you would do other procedures in the, after their menses. Abnormal bleeding, menstrual disorders, pelvic pain, many of my REI colleagues are using this for diagnosis of infertility.

I use it. Somebody is having recurrent miscarriages. A patient of mine recently had a saline sauna. It looked like she might have an adhesion.

It’s unclear whether she really has Asherman’s or not. She’s been set up for an endo c, because we wanna do it at the right time in her cycle. And, she’s thrilled that she doesn’t have to do it in the OR because the other physician that was seeing her told her she had to go to the OR. And maybe we’ll be able to snip an adhesion if it’s there.

She has a cavity filled with something, well, maybe we will have to go to the OR. But we can plan and I can plan.

It clearly identifies polyps, fibroids, all of those structural problems that we talked about.

Postpartum women that continue to bleed, another source, where they may have retained products of conception, which you couldn’t see on ultrasound, and now you can actually see and then maybe even do a D and C right then and there. It diagnoses endometrial thickening such as the serum patients, tamoxifen tamoxifen patients, which actually end up having nothing but atrophy.

If you do see an area of concern, you can actually direct your biopsy to a certain place in the cavity. There’s more uses. You may see a adhesion or a septa. You might be able to do it in the office.

If not, you’ll plan for what you need in the OR. Small polyps can be removed. Larger ones or broad based ones, obviously, no. But you can show the patient, they’ll understand what’s going on, why they need to take time off from work, and then you can plan in the OR.

A very wonderful use is for retained IUDs. Many of us do have patients who the strings were cut too short or you don’t can’t find it. You go up, you try to find it, you can’t find it. You look at ultrasound, you have your partner come in doing the ultrasound.

At the same time that you’re trying to find it, you still can’t figure out where to get it, or is it stuck in the wall? This way, what you do is you go in, you take a look. I’ve done this personally, and you can see exactly where it is to be able to remove the retained IUD. You can also see if one of the wings of the IUD is really stuck into the, you know, into the wall of the uterus and whether you need to go to the OR.

And, of course, we talked about directed biopsy. And, you know, as I’ve been saying, it gives you presurgical planning. You have a huge fibroid.

You look at their ultrasound. You look inside the cavity. You try to decide, can I resect that fibroid just with operative hysteroscopy, or I maybe I need a laparoscopy at the same time?

It really is great for presurgical planning and identifying the equipment that you need in the OR.

So here’s a few cases. Here’s an example of a saline sauna. And, yes, I think we all can see. Stick a little fluid in there, there’s some kind of lesion inside.

So then you go looking at it directly. Okay? You had an ultrasound that showed a thickening. I bet you know, initially, without the saline, there’s no question that there was gonna be something there.

You knew something was gonna be there. And then you go in under direct fertilization, and you see, wow, nice tubal osteo.

Really? You know, nothing much going on here. So you had a false positive with the saline sauna, which then may delay treatment.

So this is one example of something that looked suspicious but then ended up not being anything much at all. Maybe some debris was there giving that image. And then patient two and three, look at this saline sauna. Very similar in appearance.

You see something there. It’s unclear. Put a little fluid in there. You know, clearly, the original vaginal ultrasound had probably not a thin echo.

It really was thick, so he stuck a little fluid in. He sees a little bit of, junk in there. You don’t know if it’s a polyp or is it old blood or what is it? So you go in and you take a look.

Well, look at this, direct visualization, totally normal atrophic cavity. So who knows? Maybe it was who knows what it was? But then you can go in again, and you can actually see a polyp, and then you know you’re dealing with something.

So without a doubt, I think, you know, doctor Ziegler was another person quite well known who was really big on sailing sauna until the endo c came around, like my colleague, Steve Goldstein and, you know, people like doctor Anderson.

And here’s a case where you get see an irregular lining, but what could be better and to actually as I say here, a picture is worth a thousand words, to actually go in and take a look like all our colleagues do, whether they’re looking in the ear, whether they’re looking down the throat, they’re looking, you know, in the colon or, you know, in the esophagus, in the stomach, but it it’s really an easy way to to to look and know what we’re dealing with.

So here’s patient number five, and all three imaging for the same patient. So we have this transvaginal ultrasound.

Is there a mass in there? Well, you know something’s there. You’re not you know, it really doesn’t look normal. It’s not thin as a squeaky clean, thin endometrial echo or, what some people call a stripe.

And you put a little fluid in. Well, there’s definitely a structural abnormality. So is it a fibroid? Is it a polyp?

You know, what are we dealing with here? And then here’s the endoC look. There’s clearly you know, the endoC advance made the diagnosis, And it doesn’t take a lot of fluid. Remember, these are small uteruses.

The other day, I did one twenty cc’s I used at most, you know, and thirty cc’s sometimes.

Rarely do I use a lot of fluid because I can make the diagnosis once we, you know, do it and take a picture. Hey. There’s a polyp. There’s a broad based polyp with a really broad base.

I have to take her to the OR. I have a little small, little mini polyp. You know, clearly, I’ve tried to remove those, and I have in the office. But I will tell you, at least you have a diagnosis.

You take that picture. You turn the patient around. I show them the pictures. I show them their tulipulosity, and now they know what’s going on.

And then we plan for when they conveniently can go to the OR, and it works for her schedule and my schedule.

This is an actual video that Doctor. Goldstein took when he was doing an actual endo see. See a small little polyp?

Okay. Here’s a bigger, bigger, bigger, but the cavity was filled. You know, clearly, this is a case where then he said, now I know what’s going on. We definitely need to go to the OR.

This patient might have been diagnosed the day, and he often is into point of service. Point of service meaning doing it the day the patient comes in for abnormal bleeding. He’ll set them up. I’ve talked to him about it.

And in his patient practice, he’ll go to another room and see a patient, his MA will get the patient consented, get them all ready to go, bring in the little EndoC cart or whatever if it’s on a little table, and then do it in the exact same room that the patient was initially seeing.

That’s one of the beauties of it. Here’s a picture of retained products at conception. Patient persistently bleeding. You’ve tried some methanogen.

You’ve tried this. You’ve tried that. Patient comes back still bleeding and you wanna know what’s going on, should you do a DNC? What are you gonna do?

Do an ultrasound that shows something in there. Is it blood clot? Is it tissue? You really wanna know.

And here’s a beautiful example of retained products at conception. This patient is not gonna stop bleeding till you do something about that.

So here are some really good videos, actual videos that doctor Goldstein contributed to this slide deck.

And this was done with an EndoSee, where he’s actually looking for an IUD that he couldn’t get out without doing this. He found where the IUD is. He went in, actually could grab the IUD, as you can see, and retrieve it, you know, as opposed to going in and fishing around or worrying about actually perforating, having a problem.

So here are two other patient cases courtesy of doctor Ethan Goldstein, who has probably done the most endo sees of anybody.

He is a patient. He told me about this patient where he she needed a septoplasty, and she had that done. And, apparently, she had decided she wanted an IUD, and he was trying there’s a tubal osteo that’s beautiful, another tubal osteo we’re trying to see here. But as you can see, he was trying to assess the cavity as to whether she really could have an IUD or not. So this was another way in which he could use NOC to help this patient and make a decision rather than just going in and putting an IUD in the patient.

Now the next patient had a history of mid trimester losses repeatedly and needed an evaluation of her cavity that the ultrasound was not helpful with. And before taking her to the OR, he did this one in the office, and, you know, he basically was able to see.

She was also complaining of menorrhagia, and she had fibroids. Look at those blood vessels. It’s no wonder she has menorrhagia.

And, also, no wonder she’s had so many trimester losses. So, again, it allows for counseling and patient education and what we call shared decision making about what to do next.

And then this is something that I see myself day in and day out, really, where somebody’s having abnormal bleeding, gotten an ultrasound more commonly, sometimes not. I think an ultrasound has value because you’d, yes, get to see their adnexa as well. But you see right here this huge mass, and this is why she’s having abnormal bleeding.

And this is a perfect case, where you can plan for what you’re going to do in the OR. You can show the patient the picture.

You know, I had a case just like this on a woman who was anemic.

Look at that. In the back, I think she has a polyp. She has the cavity is filled with with, structural reasons for her menorrhagia and, planning, you know, for taking her to the OR, and then the patient understands totally as to what we’re dealing with. And these are done these are direct videos with the EndoSee from Doctor. Goldstein.

People always ask about what codes are used. They’re basically the same codes and how are they reimbursed. I mean, I’m not the expert at this, but I’m just gonna tell you that I just when I’m doing it as a diagnostic only, we use the same codes. You know, the five eight five five five. If I stop, and make a diagnosis, but we’re planning to go to the operating room, and I’m not doing anything more than that, then that’s all I use.

If I am going to actually do something, which I do most of the time, in the office, and say you’re going in and you find a little polyp, you remove the polyp, you’re really doing an operative hysteroscopy.

You’re removing the IUD. You’re actually gonna do a biopsy of a postmenopausal bleeding woman. She doesn’t have a structural problem, but you see some tissue there, and you’re also doing a little scraping at the same time. It’s definitely five eight five five eight, and you get basically, you know, paid as if you were going to the OR for the same thing, but you are not and you get the same amount of RBUs. I’m an RBU based based physician.

But I will tell you that you are saving the cost of the actual, procedure being done in the OR. This varies according to where you live in the country, I will say, so I will tell you to talk to your personal Cooper sales rep, and they can explain more of this to you than I can.

So let’s start talking and summarizing, we’re getting to the end here, about some of the advantages of this EndoSee advanced procedure. You have instant endometrial imaging guided by direct visualization rather than indirect visualization.

I do biopsies at the same time all the time. I mean, after I do this, many of time my initial pass will get fluid back. Yes. So you may have to do a few passes or use a little shark ureth, but it’s very clear. The picture is clear. It’s right in front of you. You’re having direct visualization, and you can make a diagnosis.

In the Q and A, we can talk all about, my experience with patients is they have very little or no discomfort.

People ask me if I do anything.

Well, if I’m doing it at point of service, the patient’s right there. Many a time, I will give them, depending on the patient, a few ibuprofen or and or, acetaminophen.

If the patient’s doing it on another day and I have them come back, and personally, I do something similar to what I do for this, new enhanced recovery after surgery, a little NSAID and, acetaminophen together is perfect.

I occasionally use a pericervical block. It really depends on the patient. And I do in my older patients with cervical stenosis, sometimes require misoprostol, which clearly can’t be done as a point of service. But I explain it to the patient, we talk about it, and they come back. It’s a very efficient workflow, you know, with no special in office room, can definitely reduce OR visits. This this can be literally done in the exam room that the patient is in. It’s lightweight.

Camera is right there attached to the little cannula, and, there was a study done when with the old EndoSee, actually, and the average procedure length was, you know, when you really start to finish, not prepping and not you’re you’re gonna use it in a paracylic a block and not putting your tenaculum on, but the actual procedure itself can be less than three minutes. And it’s very, very economical as far as an investment, and it’s reimbursed.

So all of those details, though, your Cooper rep can talk to you about.

So we have a new pathway. This is the old pathway that we talked about earlier and traditional pathway of all these different procedures and finally leading to doing some procedure in the OR, you know, that’s either diagnostic or operative depending upon what you have available. The new pathway looks something different. This is the actual ability at your first or second visit If it’s the first, it’s your point of service visit to be able to take a history, do an ultrasound.

I’m one that likes to do an ultrasound because I like to see if there’s anything else going on. But but, you know, clearly, if I don’t see a really thin, thin, you know, endometrial echo, then something else has to be done. So it’s either sticking fluid in with the sonogram, but I’m not great at that. I never, like, and I would much rather see with my eyes.

So I that’s where I do the EndoC advance, and then I either decide to do a biopsy or not. And then you make a decision based on what you see whether you need to go to the OR or not, or treat them hormonally or treat them medically for all those other reasons why women have abnormal bleeding. There’s no doubt that this has been shown to be accurate, efficient, convenient, patient friendly, and patient centric, and, cost effective.

And clinician, I think, centric and also clinician friendly because it’s so easy, and you don’t have to take out time. And for me, driving to the ORI because I can’t run across the street and do something there without knowing what I’m going to do and how many hours I’m gonna be there.

Well, we recently added this slide because I’m sure many of you, like myself, have lived this world of, during the COVID pandemic where I was literally, I aged out, as we say, and I was home for about two and a half months doing, what I thought I’d never do, which is numerous, telemedicine, mostly video appointments.

And one of the most common complaints that we I did video appointments about was abnormal bleeding. And it was my job to pretty much decide based on my telemedicine medicine appointment with the patient whether I thought they really should go into the health care system.

And I’m continuing to do that for my older patients.

I spend a day doing video appointments trying to plan. Now that I’m back at work, I often would do a video appointment with the patient trying to ascertain about their abnormal bleeding, deciding if they should first have an ultrasound, and then deciding whether we just set up for them to minimally be in my office, and those were the few endoses that I was doing this week. I was catching up literally on all of some of the procedures that were put off from mid March and beyond when we said no coming in.

So in the world of telemedicine, it’s here to stay. And especially now that we’re doing it in even metropolitan areas, it’s going to be able to improve our ability to diagnose and help women who are living in rural areas that generally don’t have access to us in urban areas. We are able to talk to the patient, try to get a sense as to what’s going on, find the most efficient way to work up their abnormal bleeding, and now reduce that patient’s exposure into our system and also conserve resources. Patients are reluctant not only in coming into the office, except and if they’re gonna come, they wanna come for the shortest period of time, not wait in waiting rooms, But for certain, many of them are very anxious about going into the hospital these days.

So, you know, with abnormal bleeding and the work of abnormal bleeding, we can be efficient in our workup. So EndoSee really has a great place. Telemedicine has multiple platforms. We’re probably they’re HIPAA compliant.

I think we’re all using a few different ones, but we can absolutely initiate the diagnostic pathway of finding out what’s going on, finding out whether the patient should have a regular transvaginal ultrasound first, maybe in that postmenopausal woman, I will do that. Because if their endometrial lining is three millimeters, then like ACOG guidelines and every other guideline, I’m going to wait if it’s a thin lining.

But if they’re repeatedly bleeding, then I clearly need to do something else. And EndoC is allowing me to keep that patient in the office.

I explain it on telemedicine. I get her instructions.

She only comes in to our health care system taking the first part. We’re quite talking to them and really going through the initial part of the visit in the car, and then they come and get screened. They get temperature checked. They come in, they go right into the room, and I’m ready to do my endo c. And I think that this is allowing for immediate feedback to that patient, like my two Tamoxifen patients this week, about what’s going on, and they were so relieved not to go to the OR. So I think there is a really big place for and and to see Advance as being an efficient way to help our patients during this COVID and, you know, pandemic, evaluate their abnormal bleeding and also reduce, of course, the burden on our other our health care system in general.

So this is now my colleague, Steve Goldstein, not Ethan. He’s a professor at NYU, and I’m a, you know, colleague and friend. He turned me on to this procedure. I I really do give him credit.

And doctor Goldstein, who, if any of you don’t know him, you can look him up. He is literally the the the GYN godfather of, using ultrasound in the office, transvaginal ultrasound, and he also was literally the, godfather of saline sonograms, saline hystereis. He said you have to put fluid in to rule out a structural problem. Like, he even has now endorsed using an EndoC because it’s so easy. And this is a direct quote. This new approach to gynecologic diagnosis is having a transformative effect on the management of patients with a variety of gynecologic disorders.

So in conclusion, direct visualization of the uterine cavity, without a doubt, has high accuracy of what we’re dealing with, making a diagnosis. For sure, it decreases time to treatment for that individual woman. I think it improves patient care. It’s very patient centric.

And then it maximizes, we say here, the physician’s time. And I will admit, there are some really excellent advanced nurse practitioners and PAs that actually know how to do this as well. And for sure, it’s cost effective for both the practice of medicine as well as for our patients.

So, their logo of EndoSee Advance, See Now, and Know Now, I think, is is pretty accurate.

So, thank you very much for your time, and I’m very happy to answer any of your questions.

Thank you so much, doctor Kagan. I’m going to now turn to the q and a portion of our program over to Chris Khan from Cooper Surgical who will present the questions to the luminary.

So please feel free to continue to type any questions into that q and a box, and we’ll try to get to as many as we can tonight. At the end of the q and a, there’ll be a brief survey, and we’ll really appreciate your responses.

Chris, the q and a is all yours.

Thank you. My name is Chris Khan. I’m the senior product director at Cooper Surgical, and I have responsibility for the EndoC product line. Thank you so much, doctor Kagan, for this outstanding presentation, and thank you to all of our audience members for taking time out of your schedules to attend this event. I have collated questions that have been submitted so far. Let’s try to get through several of these before we break and go to the survey questions.

But continue to please enter in any questions that come to mind, and we’ll be following up afterwards.

Doctor Kagan, our first question is, what tips and techniques do you have for first time users just getting started?

Have your rep there.

Because before going into the room with the patient, what I did numerous times was, he was there with me. We even had a little model. He went through what I was going to do before I went in there. And, and then for the first number of procedures, I asked permission to the patient.

They knew this was something that I hadn’t done. Even though I do tons of hysteroscopy, I’m honest about it. It is a little different. And, I did get permission to have I had a male rep.

I had a female rep, and they’re fine. They came in the room, and they were very respectful.

And, my MA was there with me, and we did quite a few of them with the rep present. And most people need to do a number of them with the rep present. But also going through it with them before you go in the room, that really helped a lot.

Thank you. What do you feel is the best technique for saline infusion? Do you use a syringe or an IV bag?

For saline infusion with my EndoC. I’m looking at a question here about a saline sauna.

I actually just use, a little c c syringe. There are people that use set up a bag, if they think they’re gonna need a lot of fluid. But you have to remember, this is a diagnostic procedure. This is really I have to tell you, this is not they don’t even wanna call it a they don’t even wanna call it a hysteroscopy. It’s direct visualization because it’s really a different technique. It’s EndoC.

So you take a little strand of sterile saline. I rarely use more than twenty, thirty, occasionally in a big cavity. On a premenopausal woman, I will have to use I have a sixty cc syringe loaded with sterile saline with pediatric, you know, feeding tube hooked on. And my MA does little pushes for me.

Now my colleague, a few of them do use a saline bag, because they wanna control it themselves. I find it very simple. They give me a little push, not continuous infusion because then you’ll break the seal. A little push, a little push, give me some more, and I’m directing the pushing. But I find a syringe and saline to be best.

And is it possible to visualize without using saline or any distending media just contact?

There’s no re no. I don’t I mean, you can you have to remember, this is very different, again, than hysteroscopy. I think most of us when you do a hysteroscopy, you get in, you go up to the top, you come back. Here, you just wanna get the end of that, where the camera is just inside the internal osse. You wanna just get do not break the seal further because then you’ll also have bleeding and disruption. And then you want a little push of fluid, and then usually that distends the cavity. So I can’t even imagine why I would use it without fluid.

Maybe, I guess, to see an IUD string that might be low that you could just grab and take out, but there is absolutely no reason not to put in a little fluid. And one thing I just have to tell you in all my experience, most of the patients tell me they do not feel, I ask all of them, do you have more discomfort with the fluid going in or with the biopsy? Because most often, I’ll do a biopsy at the end or I’ll do something. Okay?

And every one of them say, wow. The little bit of fluid going in you know, the uterus is small on most people. They don’t they don’t feel that as much. They do feel if you’re scraping, but they don’t feel a little bit of fluid going in.

Makes sense. Now that you’re doing NOC advanced and direct visualization in your practice, is there ever a a use for SIS these days?

I think for some people, yes. For me, no. I mean, once I can directly visualize something, I have no reason to have an indirect visual most of my patients will have had an ultrasound. So, you know, I do like knowing what the index will look like.

I also like to get an idea what an ultrasound is, you know, what I see. But for the actual cavity, remember, the endo c is looking in the cavity at the endometrium, at the ostia, and, and also the point of this. And is every picture perfect? No.

We all know that. I am using it to rule out a structural problem.

So before I medically treat the patient. You know? Or if I see nothing but a lot of tissue and I do a scraping, I get back chronic endometritis, I can treat them medically. Okay? You find out if you have a polyp, a fibroid, if you have a septum. A lot of my REI colleagues are really switching over to this from, saline sauna.

K. Thank you. And we’ll take one last question.

I know that a lot of folks have questions about reimbursement.

I wanna reiterate that we do have a resource hotline available for specific questions, And that number again is eight eight eight nine two five eight one six six.

But, doctor Kagan, what lessons have you learned regarding reimbursement as you’ve integrated Endersley Advance in your practice?

You know, I’ve what I’ve learned and I had her talk to our administrators because as I said, I’m on an RBU based. We in California, for Medicare patients, I could do this point of service. I’d say fifty percent of the time, I can easily do it. The other part, I need to give meso and prepare the patient, so I bring them back on another day and try to get them in pretty quickly.

So I think you really just need to know your, find out, have some experience with what which, you for the premenopausal women that are on commercial carriers, you really do have to find out their coverages just like you do for any procedure. Because if the patient gets some huge bill and you did it right then and there, forget it. They’re gonna that with you. So, you know, I think you just need to, work, you know, find out where you live and what the situation is.

And I know that, the reps can help you with that or Cooper can help you with that.

Great. Thank you again, doctor Kagan.