Dr. Risa Kagan identifies local pathology more precisely than EMB, SIS, or TVUS1 1 Grimbizis GF, Tsolakidis D, Mikos T, et al. Fertil Steril. 2010; 94: 2721-2725
welcome and thank you for attending this event is brought to you by Cooper Surgical, a leading provider of medical devices for women's health care. For 30 years, Cooper Surgical has worked with health care providers to provide highly effective clinic and practice based contraceptive, surgical and obstetric solutions to complement our portfolio of trusted and reliable medical devices. We have also broadened our offerings, investing in the areas of reproductive genomics and in vitro fertilization. We are fully committed to helping improve the delivery of health care to women and their families. Cooper Surgical Manufacturers over 600 clinically relevant medical devices used by health care providers and offices, clinics, operating rooms, labor and delivery suites and reproductive IVF clinics worldwide. Clinicians overwhelmingly say they trust our products for their reliability, innovation and efficiency. Here are some other interesting facts you may not know about Cooper Surgical. Since our inception in 1990 our focus has always been women's health care. With more than 600 medical devices and over 3200 product numbers across a broad range of market segments, physicians know and trust our products. We ship over 1400 orders per day, of which 99.7% are shipped the same day. Our customer service department handles over 2000 inquiries per day. We employ 1750 people worldwide. We are pleased to provide this educational opportunity on behalf of Cooper Surgical. Good evening, everyone. Hello. My name is Kelly McKee and 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 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 a mute for the duration of the meeting. However, you'll have the ability to submit any questions to the Q and A feature during the entire presentation, which you'll see at the bottom of your screen. Doctor, can you get more? Participate in a Q and a session of how 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 got Theresa Kagan. Dr. Cagan is the clinical professor in the Department of Obstetrics, Gynecology and reproductive Sciences at UCSF and Gynecologists at Center East Medical Foundation in Berkeley, California. I'll now turn this over to Dr Cagan to begin the presentation. Dr. Kagan, you now have presenter privileges. Well, thank you for joining me this evening, and I'm thrilled to be able to teach you represent to you, um, about the NDC advance, which has totally transformed my practice and my work up of abnormal bleeding and my patients that I would like to teach you why. I think this is really an advantageous a new technology or new procedure that can really help you and plan for the best care for your patients. So we're going to 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. Um, and yes, I am a consultant and a speaker for Cooper Surgical. Um, but I'll show you when we look at the original version of this How I was one of the earlier adopters. I used the earlier version, and now I'm thrilled with this advanced Endo. See, that has many more advantages in the earlier one. So Dr Ted Anderson, many of you may know who he is. He's really one of the godfathers of history. Skopje very involved, obviously with the A G. L. And this is a direct quote from his, uh, statement that he made about the ability to look inside the uterus to diagnose an atomic abnormalities that affect reproductive health. An underlying gynecologic disorders is an invaluable tool for the modern gynecologist and going on. As you can see, so it's 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 want to share with all of you something that really triggered this as being such a great procedure for me and my practice every day, day in and day out, our colleagues, someone comes in with a complaint in your ear and their mouth. They take out the ODA scope. You have a G. I bleed upper or lower. There's no way that people do. In direct imaging, r. G i colleagues, they're always doing an endoscopy or colonoscopy. I think that the time has come for although ultrasound is great and saline Sano is great for helping us. I'm not 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 and reproductive age women and midlife and beyond. It's been shown over and over again that about 30% 33% of all gynaecological outpatient visits are due to abnormal bleeding. And as a menopause practitioner, Nam certified, I will tell you that greater than 70% 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 and 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 35 older has been shown to be about 20 to 40% structural abnormalities, whether they be Pollos had endometriosis, 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 sub mucous? My oma? 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 is a possibility. You have about 60 to 80% of patients that have non structural problems that we can then work on to keep treating these patients hormonally adjusting. Even OCP s um 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. So 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. Ha. Lives are very common. I think we all see polyps. But how do we evaluate those pollens? They are diagnosed in about 20 to 40% of women with abnormal bleeding. This is one of the key reasons for a structural abnormality. And this is our beautiful pictures, as you can see. But for certain blinded endometrial biopsy in and out has a very high false negative rate for making a diagnosis of Apollo. And polyps with abnormal bleeding are often a common symptom or a sign of endometrial cancer. When you look at data, it says that the prevalence of polyps with malignancy and women with after normal bleeding about 23 24% of those may have hyperplasia. So you get rid of the policy. You have a reason why they have abnormal bleeding. They have hyper pleasure. It's important to know that. But even about 1.5% are have malignancy, so all columns that are bleeding must be removed. They must be evaluated. Now. The asymptomatic column 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 in. A blinded biopsy is not going to pick up that policy. There is a complete big polyp in this patient's uterus, so that patient, if it's not a small polyp that that pilot needs to go to the O. R. 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 hybrids, maybe a source of leaving. They often are also bleeding. Look at this picture. Large fibroid. Well, fibroids occur in about 25 to 40% of women of reproductive age, with a lifetime risk said to be over 60%. 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 too close to the cavity or, you know in the cavity some mucosal, are diagnosed in about 5 to 11% of women presenting with abnormal bleeding. These are the women that can really hemorrhage and our major consequence to their well being. A blinded endometrial biopsy has been shown again to have a false negative rate high 87 to 98% in some mucus in sub mucosal fibroids. Diagnosis. There's no way that a blinded biopsy unless you maybe you can feel it while you're doing the biopsy diagnosis. The same mucus fibroid, um, fibroids really that are bleeding can interfere with one's quality of life. Their pain, pressure and fertility and sexuality is an important, other important problem related to this abnormal bleeding due to fibroids. Um, 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, pre malignant lesion and a malignancy which could always be the source of bleeding, especially in women who are in midlife and beyond. Endometrial hyperplasia is diagnosed in about 3.5 to 4% of women who present with abnormal bleeding. And there are some studies that have shown up to a 75% false negative rate with the blinded biopsy in and out for diagnosing hyperplasia. Look at this picture over here. I mean, you even went by doing more Endo sees or history Ross copies. In general, you get to really correlate, um, 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 20 years from complex hyperplasia with Noah topia is about less than 5%. So we treat those complex, simple hyperplasia we often treat medically. But when you are dealing with atypical hyperplasia, you're on the verge of developing cancer that really needs to be addressed in a very different way, and atypical hyperplasia the risk to progression to cancer. Over 20 years, it's about 15 to 28% 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 pipe, Al. 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, um 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 40 women, and they were all known to have cancer. He did a week before the hysterectomy, a blinded little people biopsy and what came out in 39 out of 40 of those women, whereas cancer. So then what happened? The procedure Flu. I mean, everybody started saying, Oh, in and out little pipe l 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 50% of the cavity, you're going to miss it completely so And then, of course, you are definitely going to miss these structural problems. So office history Skopje has been shown again and again, as well as regular history. Skopje. But that costs a lot of time and money and time out from life. But if you can do an Office Asteras copy of direct Visualization, it's absolutely more accurate than a biopsy alone, both for Poloz, my Omagh's in hyperplasia and this one study, As you can see, looking up blinded biopsies using a little People versus history Skopje for diagnosing Pollock's, there's no question that his Doris Copy is going to make a big difference rather than a blind biopsy. The same thing goes for a structural problem. Like my Omagh's mucus. McComas sensitivity is extremely low in this study, 13% versus 100% with looking with the history scope and then for diagnosing hyperplasia. Well, you go up with your little people, you might be lucky if you get it, and if it's global or it's over 50% of the cavity, then sure, you're going to get some tissue. But again and again, looking at it is definitely better beneficial to the patient and for your treatment of that patient. I always say doing that biopsy if it comes out positive, I mean, you have hyper pleasure cancer. Well, that's that's diagnostic. But if it's negative, meaning you get proliferated. Endometrium, you get nothing. You can't stop there. When somebody is 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 a cog. Many people have seen it over and over again, and the one thing I'll say here is this is from 2012, but it was re endorsed and reconfirmed, as we say are reaffirmed by a cog in 2016. Nothing has changed. The A car guidelines do confirm that the biopsies may be insufficient, and they say that the primary role of endometrial sampling and patients with abnormal bleeding is determined whether this cancer or hyperplasia and that's it. The endometrial biopsy is accurate and 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 get through after the original Stovall study was performed. A positive result is more accurate for ruling in a disease and a negative result for ruling it out. So therefore, these tests are only an end point when they liquid. So when you do a biopsy in the office, I don't send the patient walking because you haven't figured out her abnormal bleeding unless she really has a typical complex hyperplasia or cancer. And ACOG guidelines do support using some sort of diagnostic advanced imaging, Sino historiography. Some call it sailing, sonogram and say Yes, we call it Clinical trials is definitely superior to claim trans vaginal ultrasound in the detection of the intra cavity. Every legion do your ultrasound, you put in a little bit of fluid. But then again, this is in direct imaging, so you better be really good with your ultrasound and doing your sailing saw knows. But it definitely works for many people. History Ross Copy. Maybe another alternative that is performed in an office setting or even in an operating room. But when you bring the patient to the O. R. It's more expensive to the health care system into 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 o. R. In a meta analysis that evaluated the diagnostic accuracy of history, Ross Copy 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 endoscopy these and other kinds of pasta peas. 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 a 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 Sino historiography in comparison with trans vaginal ultrasound for diagnosing the structural problems that I've been talking about. Apologies, some mucus, fibroids and women who have abnormal bleeding. They included 25 studies and what was found was the sailing sonogram was superior to plain trans vaginal ultrasound with the pooled sensitivity and specificity of 92 89% compared to the 64 90% respectively, with a P value of less than 0.1 so highly significant. Well, no surprise. If you put in a little bit of fluid, then you might be able to see the sub mucous fibroid or a real inter Cavalleri fibroid. You might really be able to see the pall of and that really regular trans vaginal ultrasound may not see the city is failing. Ultrasound was also compared with history Skopje in seven studies that had similar sensitivity but inferior specificity of about 93 83% compared to the 95 90% 95% 90%. 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 drug direct vision of visualization. Quote trans vaginal ultrasound wax. The sensitivity to be used all by itself, well, we all know that. But history Ross copy provides that direct visualization of the cavity. And then it combines it with history pathologic evaluation, which is really the criteria, that standard of practice that really should be used in the diagnosis of abnormal leading and interviewed right after mount qualities. 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 105 patients with pre menopausal, abnormal bleeding or postmenopausal abnormal bleeding, even infertility and looking out, which is the best way for detecting endometrial lesions and 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 directive 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 92% as opposed to 16 56%. That's for any abnormality. Now, when you look at polyps and fibroids again across the board, it gets better than you know, an ultrasound is better than nothing. Sticking it 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 aren't 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 various academic institutions around the country. And then I teach residents and they're busy in the clinic. Patient comes in with an 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 we'll get something. But you just can't stop there. So here's why we're not seeing it because not everybody has offices. Doris Copy. That's easily done. You have to take off time from work. The patient basically has to go either to the or the outpatient department. It's just 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 equipment it costs a lot of money. Patients may still need some kind of analgesia, and it's also costly. So traditional history Skopje, whether as an outpatient or inpatient, is a procedure, 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 hyper pleasure of 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. One does a trans vaginal ultrasound. You might do it in your office if you're good at it. Many women. Many practitioners don't happen 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 enemy Trow biopsy right then and there. Others wait till the ultrasound comes back depending on the age of the patient, depending upon where they are in their cycle at some point and they end up getting an enemy Trow, 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 sailing sonograms in a special room. If they have an ultrasound, they have a little room. They don't necessarily bring it. They may, you know, any every exam room and they have come in for another sailing sonogram. And then you make a decision about whether the patient needs a procedure or not. So it takes time to do this work up, 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 O. R. They might have a diagnostic historiography in the O. R. Even if you did it in the office. You know, basically, it's another day in time for sure. Then you make a decision about treatment takes time. This is the right people do in everyday practice now. I think there's a better way, though, that I have learned from me in my practice. Well, this is a study that actually looks at not only the benefit for the patient and the practitioner, but actually looks at the cost effectiveness of using office history. Skopje for abnormal bleeding. The overall objective was to determine whether offices Terra Skopje decreases the need for his Torah Skopje performed in the O. R. And also the financial implications. It took 130 patients with abnormal bleeding. It was in an academic center, and what you see is that 42% of them needed to go to the O. R. 58% avoid it. And if you look at the fees on the table here, the physician's fee is standard, whether they're going to do it in the office or whether they're going to do it in the operating room. But really, what we're saving is an anesthesia anesthesia fee, and in many institutions, they make, even if its I V sedation to 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 their situation to try to stay in the office first. And I can tell you that avoiding the O. R in this study may say over $3500 per patient, sometimes more. And also in using this little procedure most people have minimal to no pain. It's very flexible history. Scope for doing offices. Doris Copy And then, when needed, it prepares us to be able to plan for what equipment and what we need in the O. R. 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 his con 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, um, a fluid medium that would get stuck. We had a clean the equipment. It got to be burdensome. And, uh, when I ended up joining a big foundation, it took years before I could even find a way to do um, offices. Doris Copy Until I started using Endo C, which has changed my life and my patient's life. It's for planning if they really need to do a hospital procedure. So, for instance, this week alone, I did too. And OSI's on women that on ultrasound had thick endometrium linings with cystic change. One at a history of using tamoxifen years ago and one was currently on tamoxifen. And lo and behold, those women by somebody else was there would have been taken to the ER years ago. I would have taken them to the O. R. So these two NDC procedures for me kept them out of the O. R. And they had some endometrium. Typical SERM cystic change. But they're endometrium themselves. We're completely a trophic. 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 feet, 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 indices, I didn't understand how half the equipment we use in our office or from Cooper the pest. There is a lot of different devices are 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 going to help. My patients are just love it because they love seeing the pictures afterwards as well. Okay, so let me get to the end O c. Specifically. And this is called the end O C. Advance. This is what we're using. Uh, currently, uh, the original Ngoc came out in 2014. I learned about it through my colleague Steven Goldstein. Um, 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, um, procedure device to adapt to our practice that now I have also brought it to our residents and um, have really been able to incorporate evidence based evaluation of abnormal bleeding in a economical way, a safe way and easy way and really patient friendly. My patients are so happy when I described to them, they go online and read about it, Um, and they see what we're going to be able to do rather than just a little quick biopsy, and then also or take him to the O er for a diagnostic evaluation that may turn out to find nothing. So, um, I'm going to introduce you now to the current model that came out just this last year, called the NDC Advance. It's really state of the art direct visualization. It's been cleared by the FDA for both history. Skopje answers to Skopje, and this advanced model now has a working channel. Um, the company listened to a bunch of us who are using the other version, saying, You listen, you've got to 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 pipe, Elena. You might have had or you will have, um, it the rounded tip measures 4.3 millimeters. Um, 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 beautiful pictures right in front of you as you're doing it. Um, it's lightweight, ergonomically handheld design. This is a really much better handled than the older version for moving it around and really looking at the osteo, looking around polyps and fibroids. And I just like the fact that, um, 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 for set, its advanced because it is an advancement over the original embassy. People use it for abnormal bleeding menstrual disorders, pelvic pain, I will tell you, though, um, 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 women, just like you, would do other procedures in the after their Menzies Abnormal bleeding menstrual disorders, Pelvic pain. Many of my our AI colleagues are using this for a diagnosis of infertility. Um, I use it. Somebody is having recurrent miscarriages. Patient of mine recently had a saline Sano. It looked like she might have an adhesion. It's unclear whether she really has as humans or not. She's been set up Fernando C. Because we want to do it at the right time in her cycle. And, um, 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 ER, 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 ER, but we can plan and I can plan it clearly identifies polyps, fibroids, all of those structural problems that we talked about. Um, postpartum women that continue to bleed another source where they may have retained products of conception, which you couldn't see on ultrasound. Um, and now you can actually see and then maybe even do a DNC right then and there it diagnosis and mutual thickening, such as the certain patients to mock seven 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 O. R. 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 O. R. A Very wonderful use is for retained I. E. D. S. Many of us do have patients who the strings were cut you short or you can't find it you go up, you try to find it. You can't find it. You look an ultrasound. You have your partner come in during 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 I e. D. You can also see if one of the wings of the i o. D. Is really stuck into the, you know, into the wall of the uterus and whether you need to go to the O. R. And of course, we talked about directed biopsy. And, you know, as I've been saying, it gives you pre surgical planning. You have a huge vibrate. You look at your ultrasound, you look inside the cavity, you try to decide. Can I respect that fibroid just with operative history? Skopje. Or maybe I need a laparoscopy at the same time. Um, it really is great for pre surgical planning and identifying the equipment that you need in the O. R. So here's a few cases. Here is an example of a saline Sano. 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. And an ultrasound that showed a thickening. I bet. You know, initially, without the sailing, there's no question that there is going to be something there. You knew something was going to be there. And then you go in under direct finalization and you see Wow, nice to be last year. Really? You know, nothing much going on here. So you have a false positive with the saline Sano, which then may delay treatment. So this is one example of something that looks suspicious but then ended up not being anything much at all. Maybe some degree was there giving that image. And then patient two and three Look at this sailing Sano very similar in appearance. You see something there? So I'm clear. Put a little fluid in there. Clearly, original vaginal ultrasound had probably not a thin echo. It really was fixed. So he stuck a little fluid in. He sees a little bit of junk in there. You don't know if it's apology or is it old blood or what is it? So you go and you take a look. We'll look at this direct visualization, totally normally. Trophy 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, Dr Ziegler was another person quite well known, who is really big on sailing Sano until the end O. C came around like my colleague Steve Goldstein. And you know, people like Dr Anderson. And here's a case where you get see an irregular lining. But what could be better and to actually, as they say here, a picture is worth 1000 words to actually go in and take a look like all our colleagues do, whether they're looking in the ear where they're looking down the throat, they're looking, you know, in the colon or, you know, in the esophagus and the stomach. Um, but 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 trans vaginal 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 and immaterial 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 Apollo? What are we dealing with here? And then here's the end. Oh, see, Look, there's clearly you know, the embassy Advance made the diagnosis, and it doesn't take a lot of fluid. Remember, these are small uterus is. The other day I did 1 20 ccs. I used it most, you know, and 30 cc. Sometimes rarely do I use a lot of fluid because I can make the diagnosis once we do it and take a picture. Hey, there's a problem. There's a broad based column with a really broad base. I have to take her to the O. R. I have a little small little mini palla. 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, turn the patient around and show them the pictures and show them there to Austria. And now they know what's going on. And then we plan for when they conveniently can go to the art. And it works for her schedule in my schedule. This is an actual video that Dr Goldstein took when he was doing an actual end of seat to 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 up. Now I know what's going on. We definitely need to go to the O. R. This patient might have been diagnosed the day, and he often is into point of service. Point of service meeting, doing it. The day the patient comes in for abnormal bleeding, we'll set them up. I've talked to him about it and in his patient practice will go to another room and see a patient may well get the patient consented. Get them all ready to go. Bring in the little endo. See cart. Whatever. It's on a little table, and they do it in the exact same room that the patient was initially seen. That's one of the beauties of it. Here's a picture of retained products of conception. Patient persistently bleeding. You've tried some meth region. You've tried this. You've tried that patient comes back still bleeding, and you want to know what's going on? Should you do a DNC? What are you going to do? An ultrasound. It shows something in there is a blood clot is a tissue you really want to know. And here is a beautiful example of retain products of conception. This patient is not going to stop leading, so you do something about that. So here is some really good videos, actual videos that Dr Goldstein contributed to the slide deck. And this was done with an endorsee. He's actually looking for an I u D that he couldn't get out without doing this. He found where the I e. D is. He went in, actually could grab the I u d as you can see and retrieve it, you know, as opposed to going in and fishing around worrying about actually perforating having a problem. So here are two other patient cases, courtesy of Dr Ethan Goldstein, who has probably done the most indices of anybody. He has a patient. He told me about this patient where he she needed a setup Last e. And she had that done. And apparently she had decided she wanted an I u d And he was trying to use a tool. Austria, that's beautiful. Another to Boston were trying to see here, but as you can see, he was trying to assess the cavity as to whether she really could have an I. U d or not. So this was another way in which he could use Endo C to help this patient and make a decision rather than just going in and putting an i u D 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 O. R. He did this one in the office and, you know, he basically was able to see um she was also complaining of MENA Rosia and she had fibroids. Look at those blood vessels. It's no wonder she has Maharaja, and also no wonder she's had some mid 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 Have gotten an ultrasound more commonly, sometimes not. I think an ultrasound has value because you Yes, get to see the annex A 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, um, where you can plan for what you're going to do in the O. R. You can show the patient the picture. Um, you know, I had a case just like this and a woman who is anemic. Look at that in the back. I think she was Apollo. Bob. Just the cavity is filled with with, uh, structural reasons for her maharaja and planning, you know, for taking her to the O. R. Um, And then the patient understands totally as to what we're dealing with. And these are done. These are direct videos with the end OC from Dr 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 going to tell you that I just But I'm doing it as a diagnostic. Only we use the same codes, You know, the 58555 if I stop, make a diagnosis. But we're planning to go to the operating room, and I'm not doing anything more than that. And that's all I use. If I am going to actually do something which I do most of the time, um, in the office, uh, and say you're going in and you find a little polyp, you remove the polyp. Um, you're really doing an operative history. Skopje. Uh, you're removing i e d. You're actually going to 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 58558 And you get basically, you know, paid as if you were going in the hour for the same thing. But you are not and you get the same amount of our views. I'm in our view, they based physician, but I will tell you that you are saving the cost of the actual, uh, procedure being done in the O. R. 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 Ngoc Advanced procedure. You have instant and mutual imaging guided by direct visualization rather than in direct visualization. I do biopsies at the same time, all the time. After I do this many times, my initial pass will get fluid back. Yes, so you may have to do a few passes or use a little shark you're at. 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 as 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 patients right there many of time, I will give them depending on the patient, Um, a few ibuprofen or and or um, acetaminophen. If the patient's doing it on another day, I have them come back. And personally, I do something similar to what I do for this new enhanced recovery after surgery a little and set. And, um, acetaminophen together is perfect. I occasionally use a parasitical block. It really depends on patient. And I do in my older patients with cervical stenosis, um, 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 our visits. Um, this this can be literally done in the exam room that the patient is in. Its lightweight camera is right. They're attached to the little cannula. And there was a study done when with the old Ngoc, Actually, and the average procedure length was you know, when you really start to finish not prepping and not you're going to use it in Paris Oracle Block and not putting it in actual um on the actual procedure itself can be less than three minutes, and it's very, very economical as far as an investment, Uh, and it's reimbursed. So all of those details, though you're 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 O. R. 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 cause I like to see if there's anything else going on. 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 liked, and I would much rather see with my eyes. So that's where I do the NDC 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 O. R or not, um, 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 O. R. 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 going to 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, um, I aged out as we say, and I was home for about 2.5 months, doing what I thought I'd never do, which was numerous. Um, telemedicine, mostly video appointments. Um, 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 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 spent 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 Endo sees 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're 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 there, abnormal bleeding and now reduce that patients exposure into our system and also conserve resources. Patients are reluctant not only coming into the office except if they're going to come. They want to come for the shortest period of time, not waiting 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 an abnormal bleeding, we can be efficient in our work up. So NDC really has a great place. Telemedicine has multiple platforms. Were probably there HIPPA 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 trans vaginal ultrasound first, maybe in that post menopausal woman. I will do that because if they're endometrium, lining is three millimeters, then, like a car guidelines and every other guideline. I'm going to wait if it's a thin lining. But if they're repeatedly bleeding and I clearly need to do something else and Ngoc is allowing me to keep that patient in the office. I explained it on telemedicine. I give her instructions. She only comes in to our health care system, taking the first part. We're 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. See. And I think that this is allowing for immediate feedback to that patient, like my to tamoxifen patients this week about what's going on. And they were so relieved not to go to the O. R. So I think there is a really big place right and to see Advance as being an efficient way to help our patients during this covid and pandemic evaluate their abnormal bleeding and also reduce, of course, the burden on 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 colleague and friend. He turned me on to this procedure. I I really do give him credit. Um, and Dr Goldstein, who if any of you don't know him, you can look them up. He is literally the G in Godfather of using ultrasound in the office trans vaginal ultrasound. And he also was literally the godfather of sailing sonograms. Sailing in history, he said, you have to put fluid in to rule out a structural problem. But he even has now endorsed using and then to see, 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, very patient centric, and then it maximizes. We stay here, the physicians 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, um, their logo of Ngoc Advanced See now and know now I think, 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 Kahn 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. It'll be a brief survey, and we will really appreciate your responses. Chris, The Q and A is all yours. Thank you. My name is Chris Kahn. I'm the senior product director at Cooper Surgical, and I have responsibility for the endoscopy 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. Dr. 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, um, what I did numerous times was, um 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, um and then for a 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 history. Skopje. I'm honest about it. Um, it is a little different. And, um, I did get permission to have I had a male. I had a female rap, and they're fine. They came in the room and they were very respectful. And my m a was there with me, and we did quite a few of them with the red present. And most people need to do a number of them with the red 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 I V bag for saline infusion with my endo? See, I'm looking at a question here about a saline sano. Um, I actually just use a little C c. A syringe. There are people that you set up a bag if they think they're going to 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 we don't want to call it or they don't want to call it a history. A Skopje. Its direct visualization, because it's really a different technique. It's endo. See, So you take a little spin, too Sterile, sterile sailing. I rarely use more than 2030. Occasionally in a big cavity on a premenopausal woman, I will have to use a 60 cc syringe loaded with sterile sailing with pediatric. You know, feeding, too. Hooked on in Miami Does little pushes for me? Um, now, my colleague, a few of them do use a saline bag because they want to 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 sailing to the best. And is it possible to visualize without using saline or any dist ending media? Just contact. There's no no, I don't. I mean, you can just remember, this is very different again. The history of Skopje. I think most of us, when you do a history of Skopje, you get in, you go up to the top, you come back here, you just want to get the end of that where the camera is just inside the internal loss. You want to just 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 distended the cavity. So I can't even imagine why I would use it without fluid. Um, maybe, I guess, to see an i e d 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 flu? Are 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, Well, the little bit of weight going in the years are small, and 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 endorsee advance and direct visualization in your practice. Is there ever a use for Isis 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 visualization. Um, most of my patients will have had an ultrasound So, you know, I do like knowing what the next to look like. I also like to get an idea of what an ultrasound is. You know what I see? But for the actual cavity, remember the end. OC is looking in the cavity at the endometrium at the Ostia and, um, and also the point of this. And it's 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 endometriosis. I can treat them medically. Okay. You find out if you have a pall of fibroid, you have a septum. A lot of my r e I colleagues are really switching over to this from saline, Sana. Okay. Thank you. And we'll take one last question. Um, I know that a lot of folks have questions about reimbursement. I want to reiterate that we do have a resource hotline available for specific questions. And that number again is 8889 to 58166 But Dr Kagan, what lessons have you learned regarding reimbursement as you've integrated undersea advance in your practice. You know what I've learned? And I had to talk to our administrators because, as I said, I'm on an ARV eu based we in California for Medicare patients. I could do this point of service, I'd say 50% of the time. I can easily do it. The other part I need to give me. So 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. Has some experience. With what? Which, um, you know, for the premenopausal women that are on commercial carriers, you really do have to find out their coverage is 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 going to get 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, Dr Kagan.
