Direct Visualization Can Transform Your Practice – with Dr. Ethan Goldstein

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 thirty years, Cooper Surgical has worked with healthcare 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 healthcare to women and their families.

Cooper Surgical manufactures over six hundred clinically relevant medical devices used by health care providers in 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 nineteen ninety, our focus has always been women’s healthcare.

With more than six hundred medical devices and over thirty two hundred product numbers across a broad range of market segments, physicians know and trust our products.

We ship over fourteen hundred orders per day of which ninety nine point seven percent are shipped the same day. Our customer service department handles over two thousand inquiries per day. We employ seventeen hundred fifty people worldwide.

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

Good evening, everyone. Hello. My name is Kelly McCann, 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’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 to the q and a feature during the entire presentation, which you’ll see at the bottom of your screen. Doctor Goldstein 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’ll receive a response from Cooper Surgical or the speaker following the meeting. I’d now like to introduce our speaker for this evening, doctor Ethan Goldstein. Doctor Goldstein is an obstetrician and gynecologist at Detroit Medical Center Medical Group, Tennant Physician Resources.

He is also the founder and president of ZPOG Surgical Service, PLC, as well as the director of GYN Robotics and minimally invasive surgery at Huron Valley Sinai Hospital.

I’ll now turn the presentation over to our speaker, doctor Goldstein. Doctor Goldstein, you now have presenter privileges.

Good evening, and thank you all for attending tonight’s talk on direct visualization and how it can transform your practice.

I hope all of you and your families have been safe and are making your way, safely out of this pandemic and back into practice. It sure has been an interesting time. So thanks for carving out a little, moment this evening to go over something that I think is very, very important.

Well, you can really be sure that when we visit our primary care providers for a sore throat, that he or she will use an otoscope to help make the best diagnosis possible. And as gynecologists, we now have the same point of care ability to evaluate our patients with abnormal uterine bleeding.

NOC Advanced by Cooper Surgical provides a convenient, efficient, economical, and well tolerated platform to bring direct visualization into your practice.

The state of the art uterine assessment tool will provide your patients with the standard of care they deserve and greatly reduce the time from presentation to treatment.

So after twelve years of practice, I’m proud to say that I’ve done independent work only for those companies that have really fundamentally changed or improved the way I practice medicine.

And Cooper Surgical stands alone as being one of the companies that I feel is so dedicated to women’s health, through the tremendous products that they offer, and Endoc Advance only makes their portfolio that much stronger.

While direct hysteroscopic evaluation is the gold standard for the diagnosis of abnormal uterine bleeding because it offers an improved sensitivity and specificity for both benign and malignant intrauterine pathology.

Previously, looking inside the uterus often meant a trip to the operating room or surgery center and usually meant the need for significant patient analgesia or anesthesia, expensive equipment, and more time for us physicians.

Now while office hysteroscopy has been has become more common, it still comes with many of the same limitations.

Endoc Advance is not a hysteroscope as we know it, and that’s probably one of the most important things that I can hammer in tonight is that NDC Advanced is not a hysteroscope as we know it. Because when we think of it as a hysteroscope, it changes our ability to understand how it can be used earlier in our pathway for the diagnosis of abnormal bleeding. This portable handheld device simplifies our ability to extend our exam into the uterus without the need for expensive equipment. So abnormal uterine bleeding or AUB is defined as menstrual flow outside the normal volume, duration, regularity, or frequency, and it’s very common. It makes up about a third of our outpatient GYN visits and represents over twelve billion dollars in direct and indirect health care costs.

In two thousand eleven, FIGO, as we know, introduced the palm choline classification system to help better categorize and understand the causes of AUB.

Now when approaching the etiology of AUB in our patients, it’s important to remember that at least twenty percent and up to forty percent will be the result of structural abnormalities.

While endometrial polyps are commonly the cause of abnormal uterine bleeding, they could easily be missed by routine transvaginal ultrasound and blind endometrial biopsy.

So even though most polyps are benign overgrowths of just normal tissue, we all know they can also harbor hyperplasia or cancer.

Leiomyomas or fibroids have a lifetime prevalence of over sixty percent and are another common cause of bleeding, pain, discomfort, and also infertility.

Now these two can also be easily missed with blind biopsy.

Transvaginal ultrasound is very helpful for the evaluation of the adnexa and the myometrium, but direct visualization of the uterine cavity is the best way to understand how submucosal myomas may impact the endometrium.

Now when considering the structural causes, the palm side of the AUB equation, after polyps, adenomyosis, liamyoma comes the m, which incorporates both premalignant, like hyperplasia, and malignant uterine pathology.

While we cannot rely only on direct visualization to make these diagnoses, there are specific endometrial features that may lead us to consider one of these etiologies when working up our AUB patients. I will show you an example of this later on.

And direct visualization will distinguish global from focal endometrial processes.

And when the process is global, suction piston biopsy, like with a PIPEL, is no longer really blind. If there are focal findings, however, then such a biopsy has too high a false negative rate to be relied upon.

So the question is, if blind endometrial biopsy is so poor, why is it still being used as a diagnosis tool for AUB?

Well, the answer lies in nineteen ninety one, a small study was published that looked at forty patients with known carcinoma who had an office pipel one week prior to total abdominal hysterectomy.

Stovall reported in this study that cancer was diagnosed in thirty nine of the forty patients and published that EMB had an efficacy and accuracy of ninety seven point five percent.

Now further investigations that were published after Stovall were never able to support his claim, but rather demonstrated just how unreliable blind endometrial biopsy is in diagnosing intrauterine pathology.

As can be seen here in the results of the Angioni study published in two thousand and eight, which compared the sensitivity of outpatient hysteroscopy with blind endometrial biopsy.

Despite the poor sensitivity of blind endometrial biopsy, it continues to be front and center in the diagnostic pathway for many gynecologists.

Now what’s really alarming is that pi pal samples on average four percent of the endometrial cavity.

And the only time an endometrial biopsy is even accurate in detecting cancer is when a tumor occupies at least fifty percent of the endometrial surface area.

So because endometrial lesions are often focal, they can be easily missed without direct visualization.

And that’s why ACOG in two thousand and twelve in their practice bulletin stated that endometrial biopsy is only an endpoint when it reveals atypical endometrial hyperplasia or cancer.

Many of us utilize transvaginal ultrasound in our diagnostic pathway for AUB, but studies report that ultrasound may miss up to half of intracavitary pathology.

Ultrasound continues, like I mentioned before, to be important modality for imaging the adnexa and the myometrium, but is less sensitive for finding endometrial pathology and is less sensitive than something better that came after saline sonography or SIS. Now sonosnography or saline sonography and now office hysteroscopy with its further benefits have been shown to be superior to transvaginal ultrasound for identifying intrauterine pathology.

So I want you to pay close attention to this slide because it shows that while SIS certainly improves in the mutual evaluation, it has been shown to have inferior specificity as compared with direct visualization.

This comprehensive systematic review of imaging modalities by Mejia LeCroy was one that was actually required on our maintenance and certification in two thousand seventeen.

And it concluded, and I quote, the hysteroscopy provides direct visualization of the uterine cavity and combined with histopathologic evaluation is the criterion standard in the diagnosis of intrauterine anomalies. And this is something when I talk to new doctors who are taking on, EndoC advance and utilizing endometrial evaluation with, direct visualization earlier in their pathway, that it’s hard to sort of break away from some of the patterns that we’re used to. And SIS has been around a long time, and it’s a great modality. But if someone once told me, if you’re gonna put saline in the uterus, why not exactly see what you’re looking at as opposed to just having a two d grayscale image? And that couldn’t be more true, and I’ll show you that, to come.

This is another really impactful slide because as physicians, we rely a lot on anecdotal experience, but, really, it’s evidence based medicine that should be driving our decision making. Now this Grumbisi study was a prospective comparison of the diagnostic performance of transvaginal ultrasound, SIS, and hysteroscopy, and the detection of endometrial lesions in a hundred and five symptomatic patients.

These data clearly demonstrate the superiority of direct visualization in making the correct diagnosis.

Patients experience many different uterine disorders, which may appear similar from an outside in evaluation.

So whenever you’re thinking about traditional hysteroscopy as being more of an end diagnostic tool, the whole point of this talk is to sort of explain a new paradigm of bringing intracavitary uterine assessment to the forefront of our evaluation for abnormal bleeding. And that used to be very prohibitive for many reasons, which I’ll go into in a few minutes. However, having this portable, reposable system allows endometrial evaluation to be used easily at any time and really promotes, utilization in the early in the early diagnostic pathway for abnormal bleeding.

So if direct visualization is the best way to diagnose endometrial pathology, why aren’t most of us employing it sooner in our evaluation of abnormal bleeding?

Now simply put, until now, direct visualization meant a hysteroscopy, and there are some really big drawbacks to hysteroscopy as we know it, like we mentioned before. Many gynecologists take patients to the operating room, but even if you have a traditional rigid scope and tower system in the office, this requires dedicated procedure room, especially trained staff, necessitates longer office visits, is definitely more costly, can be inconvenient for patients and physicians, and it is uncomfortable often requiring pain management like a paracervical block.

And, also, for practices that are considering obtaining office hysteroscopy equipment for the first time, there’s a considerable cost barrier to obtaining a tower and rigid scope system.

The most important component of this whole discussion really surrounds the patient because patient convenience is paramount.

Our patients are often putting their own health needs on the back burner to address the many needs of their family members or their career. By the time they present to our office, they really want answers.

Now the above diagnostic pathway may be familiar to a lot of us because it’s how many of us work up abnormal uterine bleeding. Some practices don’t even have ultrasound, which can further prolong the time for presentation to treatment as they have to send these patients out for ultrasounds.

Traditional hysteroscopy in the OR is also inefficient for the provider, especially if there ends up being nothing found, and there’s not one of us that can say they have never taken a patient back and found nothing on hysteroscopy. It’s happened to every one of us. So there’s got to be a better way.

Knowing that endometrial pathology is the cause of abnormal bleeding in twenty and up to forty percent of our patients means that in sixty to eighty percent of our patients, we have to consider the choline causes.

Now there is just as much significance to finding nothing on direct visualization as there is to diagnosing uterine pathology. And ideally, we’d like to know this before going to the OR. This is a point I really wanna drive home because some people say, well, what if I put a patient through this procedure in the office and I see nothing? Well, let me tell you something.

In my experience, having a postmenopausal patient in the office and doing an endo c advance and finding nothing but atrophic endometrium, you’ve now just made that patient’s day. They don’t have to wait around for another procedure or to find out if everything’s gonna be okay. You’ve reassured them right there that the endometrial atrophy or polyp is more than likely the cause of their bleeding. And I’ve had countless hugs and tears with patients that are just so relieved to find nothing.

So don’t think that if you look inside and don’t see anything, that somehow this is a failure because you’ve just saved that patient a possible OR visit, and you’ve given them a a definite pathway by which to take them down. Now this slide is also a really crucial study. MOAD study in two thousand fourteen makes a compelling financial argument for utilizing office hysteroscopy to triage those patients that need to go to surgery. In this study, as you can see, sixty percent of patients avoided the operating room by utilizing diagnostic hysteroscopy in the office, which resulted in significant cost savings for the patients.

Now Cooper Surgical is a name that we’re all familiar with because they provide many products that we use in women’s health care today. Our offices and operating rooms stock their trusted and reliable products, and it’s no surprise that they were the ones to bring EndoC to market to meet the need for an even easier patient centered and affordable way to directly evaluate the endometrial cavity.

In two thousand fourteen, the first generation of EndoC was released. And in May of two thousand nineteen, EndoC Advance, which really improved on the success of its predecessor, finally arrived.

So let me take a minute to describe the EndoC Advance. It really is comprised of three components. The first being a reusable display module with a large high resolution color LCD touchscreen.

There’s also the sterile single use cannula, which balances flexibility and stiffness for ease of insertion with a rounded tip that’s four point three millimeters in outside diameter.

The working channel is great for therapeutic instruments that are five French diameter.

You have a very ergonomic positioning of a still image and video capture button, which can then transfer to the computer and EMR, and you have an ergonomic pistol like grip handheld design for ease of control and insertion.

And then when you’re all done, there’s a docking station for efficient image transfer and charging. NSC Advance offers a broad range of uses, which may include evaluating patient presentations for abnormal bleeding as we’ve discussed, but also pelvic pain, infertility, identifying pathologies such as polyps, fibroids, endometrial thickening, and even atrophy, and performing in office procedures such as transaction of adhesions, small polypectomies, or removal of retained IUDs.

And there are many patient cases where this makes sense. So now we’re gonna talk about some cases, and these cases really illustrate the impact of EndoC as a triage tool for direct endometrial evaluation.

Now in case number one, I want you to look closely. Does the sauna histogram show an intracavitary lesion? It It really looks like it does. But upon direct visualization in the same patient, the cavity was normal. So as we know, false positives can complicate and even delay the evaluation and treatment process for our patients.

In cases two and three, SIS and EndoC both use saline in the uterine cavity, but clearly there is no substitute for seeing exactly what may or may not be within the endometrium.

Similar images on SIS can appear very different from an inside and up close evaluation.

So in case number four, it’s difficult to see what’s truly going on. The picture on the right, believe it or not, is of the same patient, and even the most seasoned among us can be fooled by an SIS or ultrasound image.

This is one of my favorite slides because it does show three imaging technologies, ultrasound, SIS, and EndoC Advance in the same patient.

So with the transvaginal ultrasound image on the left, it’s difficult to see, is there something going on in the center, or is it just thickened endometrium?

With SIS using some saline now, there definitely appears to be a structural abnormality, but it could be a fibroid. It could be a polyp. We’re really not sure. And then with direct visualization on the right using EndoC Advance, we can now achieve the clearest image possible and give the patient the diagnosis of a polyp and explain our next steps in terms of taking her to the operating room for a polypectomy.

So if you remember before, early on in this talk, I mentioned there are times when direct endometrial evaluation may actually help diagnose endometrial disease.

And even though we can’t always rely on what we see, we have to back it up with a pathologic diagnosis. This is an one such example. This is actually a patient of mine who was forty two years old, presented with abnormal uterine bleeding. The endosy demonstrated hypervascular polyps, and the endometrial biopsy was actually benign proliferative endometrium and some polyploid tissue.

But because of what we saw on the endosy advanced photographs, the fact that those polyps didn’t look normal, I took her back for a MyoSure, which was consistent with simple endometrial hyperplasia with atypia. She eventually went on to have a hysterectomy and did fine, but this is a really good example of how had I not looked before I biopsied, I would have missed the diagnosis and delayed the diagnosis for this patient. So after having EndoC and EndoC Advance for some time, I became much more comfortable utilizing and deploying this technology, sooner in my evaluation of patients with a multitude of conditions.

So this is a patient that you may not think about in terms of an early utilization of EndoC Advance, but this is a perfect patient that I think in the future, we will see EndoC Advance become really the standard of care for the diagnosis of products of conception tissue because we know we all know how frustrating it can be. This is a twenty one year old with abnormal uterine bleeding, eight weeks status post of normal spontaneous vaginal delivery.

She actually stopped bleeding six weeks after her delivery and then began having some irregular bleeding after the fact and came into the office. And I think a lot of us, including myself, may have just kind of blown it off, but something just didn’t seem right.

So I didn’t have ultrasound in the office. We all know how inconsistent and unreliable ultrasound findings can be with retained products at conception. So I consented her for EndoC Advance.

And now I’ve done this several more times, and I really have just decided to replace transvaginal ultrasound entirely in the with these patients and go right to EndoC Advance. Because now I know right there and then what I’m dealing with, and we can take them back and do a DNC and get them back with their family, back with their newborn, and on the road to feeling better. So like many of us getting an NOC Advance in our hands, it doesn’t take long to realize some of the benefits of using this device with some of our IUD complications, And this is what cases number eight and nine demonstrate.

Case number eight is an IUD retrieval, and we’ve all put patients through the discomfort of trying to do this blind or with ultrasound guidance. It’s very, very difficult. So why not put EndoC Advance in, use the working channel with a five French instrument, and directly visualize the strings and remove it right there and then?

Patients are so much happier. It takes so much less time and is very, very, very tolerable in the office.

So, again, somewhere you may not think about using this technology, after a while, you really realize what a broad range of, options you have with NDC Advanced.

So in case number ten, this is a twenty four year old that presented with a history of septoplasty, a remote history of septoplasty that really wanted an IUD. And we all know that IUDs are contraindicated in patients with cavity irregularities and congenital unit anomalies because they may not sit properly and they still run the risk of becoming pregnant. So I decided before going any further with this patient, let’s just take a quick moment, do an NDC advance, extend my exam into the uterine cavity, and lo and behold, as you can see, even though she had a septoplasty that drastically improved the contour of her endometrium, it still wasn’t sufficient for IUD placement. She went on to, using some other form of birth control. In case number eleven, this is one of my favorite cases. This was a fifty one year old with menarrhage and fibroids, and she was here to have a preapendometrial biopsy. And like I said, I don’t like doing things blind, so I wanted to look beforehand.

In my workup with this patient, she mentioned that she had two mid trimester losses in her youth, but never really understood why. And, actually, taking the time afterwards to sit down and show her that she had a congenital uterine anomaly, in this case, a bicornuate uterus, really helped that patient understand her unfortunate obstetrical past.

So why not leave the best for last? And that’s exactly what we did here. This is one of my very favorite slides and videos to show. This is a fifty one year old who came in with abnormal uterine bleeding.

And I kid you not, the patient was sitting there on her phone texting or updating or whatever she was doing, and we just dropped this, endocidvance in. And lo and behold, this beautiful type zero myoma greeted us in lower uterine segments. And as we traversed around it very easily, she kept texting or doing whatever. We got to see this beautiful fundal polyp.

And I can’t tell you how much fun this was to morsely.

But this was a great example of not waiting for ultrasound and having given the patient an answer right there and then. And I thought she’d be so impressed with this because, obviously, as physicians, we’re impressed, and she was just sort of like, okay. What do we have to do? And I’m like, you know, but look how beautiful this is. This is absolutely amazing. So the best for last is a combination of a leiomyoma and a polyp.

So as we’ve discussed, multiple times throughout this presentation, this is really about the patient. And EndoC Advance is a very patient centered, tool that really helps us do our job better for our patient’s sake. But it’s really even cooler in the fact that it actually has a benefit for us in our practice, our efficiency, and economically. Now many of you may not know, but in July of two thousand seventeen, CMS increased the reimbursement for CPT code five eight five five eight by two hundred and thirty seven percent, and I believe this was done to keep patients out of the OR unnecessarily and reduce the overall financial drain on our health care system.

Now employed physicians such as myself who generate the same RVUs regardless of where we do our procedures, using EndoC Advance can stay in the office while providing patients an efficient and more comfortable way for endometrial evaluation.

So let me just review with you some of the advantages of EndoC Advance. It provides instant endometrial imaging guided by direct visualization, which we know is the gold standard.

We can even do a biopsy at the same time using the working channel. There is a clear color display for accurate visualization across a wide range of conditions like we discussed.

Patients experience little or no discomfort, and I can go into this more later, but I don’t use paracervical blocks with these patients.

And they’ll all tell you that an endometrial biopsy is much more uncomfortable than the EndoC.

It provides an efficient workflow within office exams and that reduces operating room visits, which is a win win. It’s convenient, and you can use it in any room at any time with an average procedure length of about less than three minutes.

And it’s also a low cost investment used in really reimbursable procedures. So for those doctors who are looking to start off with office hysteroscopy, it’s a great way to do it with EndoC Advance. So I think we can all agree that direct visualization ultimately provides patients a better way to reach their diagnosis sooner. Now we have to also take into account cycle timing, office policies, and payer restrictions, but it’s even possible to use MSC Advance as a point of care diagnostic tool to immediately extend our physical exam into the uterine cavity.

And I’ll tell you, this is not something I expect you guys to just pick up and do day one. And I’ll tell you a funny story, and that is when I first got MOC Advance and when my partner and I saw it before even Cooper Surgical acquired this device, I wanted it, like, right then and there. It’s kinda like the newest iPhone, right, or Android. You want it the next day.

You want it as soon as possible. I saw this end of the scene, and I was like, this I gotta have it. So fast forward a few more months, we finally, obtain the end of the scene, the first generation.

It’s in my office.

And, my rep comes to see me a couple months later and says, you know, how how do you like the EndoC? And I actually had forgotten about it. Here, I was so excited to get it. I forgot about it.

So what I did is I put it right next to my workstation. I actually put the handheld piece in my white coat, took my, stethoscope out, which I don’t use that often, and it was just a reminder just so I could start utilizing the this piece of equipment. And lo and behold, it didn’t take very long for me to get very comfortable with it and start employing it, as a point of care device, and I’ve never looked back. So I don’t expect, this paradigm to change overnight for any of us.

It’s something that takes time. We have to understand the evidence behind it, which I think we’ve discussed, and you see that drug visualization is better for our patients and for us, keep people out of the operating room. And if we do go to the operating room, we know exactly what we’re going for. It’s not something that’s gonna happen overnight.

The learning curve is relatively short, but just put it somewhere where you remember that it’s there because it’s very easy to forget and go right back into our normal routine, endometrial biopsy, ultrasound, OR. And when you see it in front of you, remember, yes. You know what? Let’s take a look before we biopsy, and maybe we can, definitely change the way we work up and evaluate our patients.

Well, prior to March, I would say that most of us may have just kinda heard of telemedicine, but I’m pretty sure that now, status post COVID nineteen, a a lot of us are very intimately involved with telemedicine and incorporating into our practices.

Interestingly enough, telemedicine actually started as a way to provide remote clinical services in an audio or visual format to those communities that were not, within reach of medical centers, and it was used to initially to improve health care in rural areas. So now we’re utilizing telemedicine to reduce patient exposure in clinical settings and make it more convenient in the in this new world that we face. Even though there are multiple telemedicine platforms that exist, and early on in this pandemic, we were allowed to pretty much do anything that allowed us to have face to face contact and improve patient continuity, it’s really important going forward that we pick and stick with one that’s HIPAA compliant, and there are many out there.

How do we use telemedicine in terms of our assessment for AUB? Well, much in the way you would talk to a patient in the room anyway before doing an exam. You would get a detailed history, and telemedicine provides a great way to do that in the comfort of the patient’s home. So you can initiate your diagnostic pathway by obtaining your history of present illness, and then you can triage that patient to imaging, endocy Advance, both, maybe labs, and go from there.

And this really has allowed us to increase, our ability to keep our patients safe, to keep social distancing in our practices, to reduce the volume initially, and just bring those patients in that have to be seen. And it’s important, obviously, as we know, if we have a patient that’s got heavy bleeding to the point of, you know, having to change a sanitary napkin every hour or who shows signs or symptoms of orthostasis, that those patients need to be seen immediately and sometimes in an emergency setting. So telemedicine may not always be the right, may not be the route for everybody, but at least it’s a great triage tool to get our patients where they need to be for the next step.

Now along the same lines, EndoC Advance provides an efficient way to triage OR candidates like we discussed. Up to sixty percent of patients can avoid the operating room with EndoC Advance, And this can really help reduce the burden on the health care system. If there’s anything that we’ve learned right now, it’s that our health care our health care system has been burdened.

And even though we now have more supplies and more ventilators and such, it’s still important to utilize our equipment, efficiently, effectively, and smartly, making sure we’re utilizing it, for the right reasons.

And that being said, now that we’re able to do elective procedures in the hospital again, there’s such a rush and backlog of patients. We’re gonna find it harder and harder to get operative time. And for me, I’d much rather use my operative time for operative procedures and keep the diagnostic ones like Endosc Advance in the office.

So although he’s not related to me, doctor Steven Goldstein, who is arguably one of the world’s leading experts in transnational ultrasound and SIS, has also embraced direct visualization using NFC Advanced and refers to this technology as transformative and the new standard of care for endometrial evaluation. So for those of us who are not maybe so much early adapters but need the stamp of approval from, those people that have studied and, done a lot of research in this area, who have given oral exams, who have written numerous papers and published in ACOG and many other, many other important journals, in our industry, we have a stamp of approval from somebody who’s very, very important, who really brought to the forefront the use of SIS for office, evaluation of endometrial pathology and who now sees the benefit using NDC Advanced for direct visualization.

So to best summarize or wrap up this talk, I think we can all agree that direct visualization is not only the gold standard for evaluating uterine cavity, but now is the standard of care for early evaluation to help triage our patients to get to a diagnosis and treatment sooner. Because as we’ve learned, correct visualization of uterine cavity provides a high accuracy of diagnosis, decreases the time from presentation to treatment, making our patients happier, It improves their care, and it maximizes our time as physicians. And since we are so busy and even busier now coming out of this pandemic, it’s really important that we’re able to keep our diagnostic procedures in the office with a tool that’s cost effective, easy to use, and comfortable for our patients.

So I wanna take this time to thank you all for attending tonight’s talk. I hope you got something out of it, and I hope that you have more comfort and understanding about using a direct, endometrial evaluation of NDCADVANCE earlier in your diagnostic pathway for your patients with a multitude of conditions.

And I’d like to open it up for questions.

Thank you so much, doctor Goldstein. I will now turn the q and a portion of our program over to Christopher Khan from Cooper Surgical who will present the questions to Luminary. Christopher, the q and a is all yours.

Thank you, and good evening. My name is Chris Khan, and I am the senior product director at Cooper Surgical responsible for the Endoscopy Advanced product line. I’d first like to thank doctor Goldstein for a very excellent presentation, and I’d like to thank each of our audience members as well for taking time out of your busy schedules to end this event. I’ve been culminating questions submitted throughout the presentation, and I’d like to get to as many of these as possible. If we do run out of time, we will follow-up with the individuals who submitted any remaining questions.

So let’s jump right in. Doctor Goldstein, our first question is, how do you explain Embassy Advance to your patients to put their minds at ease?

That’s a great question, Chris.

And I do take the time to explain to them, whether it’s point of care, the time that they’re presenting for the first time with a complaint of, let’s say, abnormal bleeding. I describe it as a way to, like I mentioned in the talk, extend my exam into the uterine cavity.

I compare it, somewhat to an otoscope. Although, obviously, it’s a it’s a little different.

I have diagrams up in my office to demonstrate the female anatomy, which many patients are not really aware of, especially the internal anatomy, and explain how different imaging modalities help look at different parts of the anatomy and how endoC is very important to look inside the uterus where other things such as ultrasound can miss things. And so, most patients are very, understanding of this. They they see the point right away. And I’ll tell you what’s what’s really great.

I did a I did a few today in the office, where I turned around and showed the patient the video, of of what I found, and both had really interesting findings. And they were just mesmerized, to walk out to the same day with, that knowledge and understanding of what was causing their issue and then how to go forward from there. So I do take the time. Obviously, we do get informed consent.

You know, we go through all of that same process.

But it it’s very, very easy. It takes a little time to explain and show them with the diagram exactly what it’s for and how we’re gonna use it.

Thank you. Our next question is you mentioned, COVID nineteen and the use of telemedicine.

How do you see NDC advance getting into your office practice during these times of social distancing? What changes have you done? And, especially, how do you see this evolving?

Well, that’s that’s great. We kinda touched on that a little bit. But to expand on that, you know, certainly, it it fits in nicely, you know, first of all, to, triage our patients who have to go to the operating room because, you know, patients have concerns about going to the hospital in the OR, and they should.

And and so if we can eliminate those people that we don’t have to take, that we may not find anything in the operating room to do all those diagnostic procedures in the office, we’ve saved them the anxiety and time, to do that.

And then when we do go, we know exactly what we’re going to encounter. So just the other day, I had a patient who I, you know, evaluated during this time, initially with telemedicine as her initial, visit and then decided based on her symptomatology and what she was explaining to have her come in, to do an ultrasound and possibly an endo c. And on the day of her ultrasound, it really didn’t show much, and I was a little bit maybe reluctant to do the endo OC, but her symptoms really concerned me for intrauterine, you know, pathology. So I did.

And sure enough, she had a, about a two centimeter fibroid, semi mucosal, fibroid that we just then took her back to the operating room, earlier this week, to yesterday to, to address. So, again, taking someone who had to go to the OR for something that was surgical in nature. I knew exactly what equipment I needed. It wasn’t a possible possible, scenario, taking up more time, more personnel, more equipment.

It was very, very quick and efficient.

And in terms of in general, in our office, we know we were quick to hop on on the telemedicine. I I thank, Tenet for that because they they really wasted no time, getting us up and running on that and, utilizing. And patients really like it. I think it’s very convenient for people, even our older patients who may not be so tech savvy. You know, some of these newer technologies are are pretty user friendly.

And when explained, they’re they’re very happy to sit in at in the comfort of their home, to not have to go out and about and to go through at least the initial process of the history, of present illness so we know exactly, you know, how to how to proceed.

Good. Thank you. Our next question, it’s actually two questions that are related.

How do you handle pain management the same day endoscopy use? And, also, do you do any other premedications?

Do you use CytoTech?

These are questions, Chris, that we we hear all the time, and, it’s it give me one second.

So first of all, the Cytotec question, let me go backwards on how you asked it.

There are certain patients that are not candidates for, you know, first of all, for in office procedures. So knowing your patients and knowing their pain threshold and understanding who may or may not, fit that category is important. That being said, I would say most patients can tolerate an endoc in the office, because most of the time, we would do an endometrial biopsy in the office. And undoubtedly, endometrial biopsy is more uncomfortable. Cytotec is something I will use for a patient if I know they’re coming in with postmenopausal bleeding. I’ll try to anyway.

The the staff will direct them to me ahead of time, to get, misoprostol. I use two hundred micrograms the night before and the morning of their procedure.

In terms of pain management, whether it’s point of care or, you know, you know, coming in for a scheduled endo c, it’s ibuprofen, you know, at the time that they arrive. I don’t use pericervical blocks. I mean, I could count count on one hand in the hundreds of cases I’ve done where I’ve used a pericervical block. Pericervical blocks tend to be uncomfortable.

A lot of people don’t really know how to do a good pericervical block or uncomfortable.

I know many of us are just not comfortable doing office based procedures in general, but you’d be surprised if you put IUDs in or you do any mutual, biopsies. Endoc really, is less uncomfortable than these common procedures and really requires nothing more than some ibuprofen that will kick in, you know, post procedurally to allow them some some relief from cramping.

Thank you.

How do you achieve and maintain cavity distention?

And can you specifically talk about the use of an IV bag versus the syringe?

Surely. So I I started off my pathway with EndoC, the first generation using, a sixty c sixty cc syringe.

We’d have maybe an extra one or two on hold if we needed it.

I have found over the years that a five hundred or liter bag of saline on pressure, is definitely superior to that. It allows me to have less personnel in the room. So it’s just me and the MA reducing, you know, exposure risk, reducing traffic in the in the in the room, making the patient more comfortable.

It allows me to have control of the inflow of the saline, so the distension, and relaxation of the cavity depending if they have a patulous or pair of cervix.

You know, we can control the the flow and, you know, gives us more time, especially if we see something that we wanna biopsy or remove, instead of having to to to kind of fiddle around with, you know, more than one thing. That’s just happening just like it would in the OR, and then you can take the, five French instrument and guide it down the working channel to take care of what you need to.

And, actually, you can reduce the flow at that time to reduce the discomfort, until you are ready to do your biopsy. So just having that control and that, dramatically improves visualization, I think.

I used it today actually on a patient who was still, having bleeding, and it was just because, you know, scheduling for this patient, she really wanted to have this evaluation today. And so having that saline bag running allowed me to kind of flush out, you know, some of the endometrial tissue, to better see what was going on. So, you know, patients who have larger uteruses or, who who are like this, who are bleeding, also very helpful. So just having that bag, I think, eliminates that question of will I need more, and frees up hands to do more while you’re looking.

Okay. Thank you.

How does one handle the procedure and then the reimbursement code also when doing a biopsy after seeing pathology on the end of the visit?

So that’s gonna be regionally specific based on pay or mix.

And, you know, that’s a great question. I I have all my patients are, pres you know, prescreened by the front.

In terms of those patients, they know what to look for if a patient calls coming with a problem visit, who may or may not need an endo see. And even if I find that in talking to someone that I think they need one, I make sure the front, you know, goes through the process to get authorization.

And if their insurance allows it, then we will go ahead and do it. And the patient obviously will, understand what what financial responsibility they may or may not have at that time. You know, we explained to them in this era of high deductible plans, it’s not uncommon for patients, especially early on in the year, to have to pay more for procedures. But I really can’t tell you that I’ve had anybody complain, about that because, again, they understand why we’re doing it.

It gives them an answer that much sooner. You know, take you know, when you when you do something like this point of care or sooner in the pathway, you’ve reduced the number of visits that they’re having to to make to get to the end, diagnosis and resolution. That means the less time they have to take off of work or the less they have to try to get childcare, and the less inconvenience. So even though there may be an expense and there is often an expense associated with it, they’re willing to accept that because they’re really getting something of value for it.

So it’s, it’s never been an issue. And I and I check-in with my billers every once in a while. Hey. We have a pushback. You know, patients sometimes, you know, we all know have will get to us finally with a question about, hey. I got this bill for whatever.

You know, I’ve gotten those questions for lab bills or for weird cultures or things like this, but never have I gotten a question or concern about, payment or reimbursement, for end of c advance.

Okay.

You showed a number of interesting cases, but you didn’t show any case where you avoided surgery except for atrophic vaginitis.

Can you do you have examples? Can you give examples of avoiding surgery?

Well, sure. I mean, absolutely. There’s, well, there was a couple cases in there where if you looked at the SIS image or or ultrasound image, it looked like there was something. And, you know, if you didn’t have SIS in the office or even if you did and you saw some of that cavity regularity or it looked like, you know, abnormal tissue, you might have taken that patient to the operating room, and a lot of us have, I certainly have, to find really nothing.

So those are those are examples themselves.

But the postmenopausal leader with the atrophic endometrium is one example.

Another example would be someone who comes in, you know, who you think may have, intrauterine pathology.

You take a look and, you know, you see nothing at all. No matter what her age is, you’re not taking her to the operating room for the same diagnostic procedure. And at that same visit, you say, you know what? Let’s go ahead and check a hormone panel.

Let’s check labs, see where things are at because, you know, you’re you’re one of those twenty to forty percent that don’t fall into the the palm side of the equation, and there’s some other issue going on that we needed then, you know, try to hunt down and address. So, no. Correct. We didn’t really show much except for the, atrophic, endometrium for the postmenopausal bleu because I think that’s a really profound one and one that I can really relate to in terms of, patient satisfaction, and really kind of made the point that I was trying to explain of finding nothing is just as important as finding something, especially in in these patients.

So, yeah, if it’s a younger patient and you look in and don’t see anything of, you know, concerning lesion wise, and I’ll still do endometrial biopsy a lot of times because let’s say, what just come to mind came to mind is somebody I know who, young gal, thirty eight, who just last week was having, has an Nexplanon and was having unexplained bleeding. And, you know, we worked her up. Ultrasound was fine. Labs are fine.

You know, she had the Nexplan for quite some time, was very happy with it. I was expecting her to find the atrophic endometrium because sometimes progesterone, only birth control can do that. That was not the case. So I did end of the C, and didn’t show much at all, to be honest with you.

A little bit of hyperemic endometrium and, you know, I sort of said, I don’t know. I don’t have much for you. This is what we saw. I did a pretty, thorough, you know, kind of a DNC with the Explora Curette.

Got a lot of tissue back. Came back chronic endometritis.

So that’s another example of something where you may not, you know, you know, you don’t see anything, but, you’ve now saved that patient a trip to the operating room and also come up with a diagnosis that you can treat and improve their, symptomatology.

Thank you. For this next one, I will combine combine two questions into into one.

What disposables are needed for a procedure with EndoC, including instrumentation, and what advice do you have for first time users?

Good questions.

So disposables really, you know, we use an, you know, under buttocks drape.

The actual endo c cannula, like I showed in the in the in the presentation there, is disposable.

The, the, extension tubing and saline bag, obviously, those things. Everything else, you know, I use a disposable speculum sometimes with a light on the end of it. Sometimes I don’t. I like to use an open sided spec because you can take the open sided spec out, and then the patient’s more comfortable, plus you have more flexibility to move around, and look, while the patient’s more comfortable.

Repeat the last part of the question. Woah. First time users’ advice.

I would utilize your, your local Cooper Surgical NSE reps because they are invaluable in terms of their experience, their knowledge base, and their ability to sort of help you through that learning curve.

And so, you know, the first five to seven, maybe even ten cases, having them, available, trying to, you know, maybe book a few cases in in one day, so that you can kinda just get that repetition down, that familiarity, kinda work out the kinks, so to speak, is really important. And, you know, in terms of trying to get comfortable with it, think about utilizing it any patient that you would do an endometrial biopsy because, really, as the evidence shows, we really shouldn’t be relying on buying blind endometrial biopsy. Nowhere else in medicine do we just blindly biopsy things. Oh, she’s got a breast lesion.

Let’s just blindly, you know, put a a needle in a mask. We don’t do that. We image and guide have guided biopsies and everything else we do. Why not have a guided biopsy in the uterus?

It just makes sense. So think about it that way. Okay. This patient needs an intermitral biopsy.

Let’s go ahead and take a look first.

That would be my advice.

Thank you. How do you handle patients with cervical stenosis?

That’s another great question.

So, again, premedicating these patients with, Cytotek.

And, this is a four point three millimeter device, and hydrodissection is really important. So I start off I use the OSFinder.

OSFinder allows me it’s actually another Cooper product that I never knew about before I started doing NOC and NOC Advanced. It’s a real flexible soft, tip, dilator that really allows me to basically, it’s my it’s my pre op pre procedural assessment device. And if I can pass that easily enough, then I know I can give an EndoC.

And even if I can’t, and there have been times, like, even this morning I know it’s kinda funny that this happened on a day. I actually had some some cases in the office. I had a menopausal woman with, fifty nine year old postmenopausal bleeding, and she had the longest, most torturous, endo or cervical canal. As a matter of fact, at one point, I actually thought the, internal, cervical os was, one of her, you know, tubal ostea.

And I just maybe missed the other one or maybe she had a even an anomaly. I spent time coming back and forth and back and forth, and sure enough, that was actually the internal cervical os. And I just kinda gently pressed through and, voila, here we were in the cavity assessing this, this lesion that she had that her primary carrier picked up on, ultrasound. So the hydrodissection is key.

If you can get the, the Ospfinder to start the way and use the hydrodissection, with the with the cannula, it does it for you, and it’s beautiful. It just kinda opens up that pathway. So I find it actually easier to do it with this because you also have that pistol grip that you can kinda use to move around the, the the curves and turns in the endocervix to overcome, most, stenosis.

Okay. If you have an endometrial polyp and you’re trying to remove it with Endoscopy Advance, how do you manipulate your instrument to optimize removal?

Well, because of the way that the, you know, the instrument comes out, below the device, it’s basically just, you know, positioning, you know, with the with the pathology as clear in front of you as possible.

And then, you know, positioning that, you know, watch so you can watch the, the grasper or whatever you’re using, spoon forceps, come out, of the tip, and and then you gotta move things together. So you kinda have to to to sort of, marry your hands together. It’s kinda similar to how we used to do procedures, how we’d have to kinda, you know, marry the scope and the, and the the hand that was feeding the device at the same time. It’s no different than that. But, you know, we’re we’re we’re surgeons. And so as surgeons, you know, we’re very capable and, proficient in doing things like this.

And I think having the the ergonomics of the grip and the screen now in front of us like this, with the, working channel where it is, it makes it very easy and sort of intuitive as to how we, you know, move in position to, grasp pathology. It’s important to remember that unlike maybe with a rigid, you know, wider borescope that we have to kinda take things out together. So once you’ve actually grasped the pathology, both hands have to come out together, and then you go ahead and and drop it off and and then come back in if you want to. So don’t pull it won’t it won’t pull you pull through the cannula, by itself.

Thank you. How do you handle sterilization of operative instruments when you’re faced with back to back cases, or do you use disposable instruments?

So like I said, most of the stuff we use is disposable.

You know, this we use disposable speculums. So, and the end of the sea, is charging on the dock. You know, we just take it off and run with it. It, you know, has enough, juice, for for our day. We may do, you know, up to, you know, four four or five cases. I think the most I’ve done is six in a day. And, you know, a lot of those cases are being sent to me, so it’s not like these are just coming out of the woodwork.

And so, you know, we’re looking at you know, I use a tenaculum. So sometimes we may I’ve had cases where we’ve run out of tenaculums, and then we have to switch to, Alice’s, to to do what we need to do to for cervical stabilization. Or if someone’s, you know, parous enough, patulous enough, you don’t need to do that. That’s fine. Some people prefer not to.

So, you know, I haven’t really had a instance where I’ve run out of, of things like this. The, the, we do have enough of the sterilized, five French instruments. I think, you know, three or four. We have two offices in each office. And now I know Cooper has, come out with a disposable, inoperative instrument, grasper, to fit through that working channel, which I’m, eager to to use.

So I think that will help, you know, that we’re not having to turn over, you know, reusable instrumentation if we have a really busy day.

And For patients.

Chris, sorry to interrupt. We have time for one more question this evening.

Okay. For patients with high out of pockets, do you do the procedures in in office, or do you go straight to the OR to avoid two procedures?

Well, you know, that’s a that’s a great question, and that’s sort of a judgment call. But, if I can you know, an out of pocket expense coming from my office doing an endo c with one code, is a lot less than a hospital, you know, with the pre op and the anesthesia, anesthesiology fee, the OR fee, facility fee, is much more, of a burden, than, you know, basically doing it in the office. So, you know, if I and, again, it’s the benefits of knowing exactly what I’m gonna be seeing, you know, knowing if I’m gonna do an operative morseletion type procedure, which blade I need to have, what setup I need to have, which fluid management system I want.

Having all that and, you know, knowing that ahead of time makes me more efficient in the operating room and saves time on that side as well. So, you know, again, we we go through with our patients. We we explain to them the importance of it, give them the option. But, like I said, most people are very willing and happy to have an answer and a pathway right there and then.

And that’s, that’s where I find utilizing in mutual evaluation with NUC earlier in the pathway to really be, superior to how we used to do things.

Thank you. Thank you once again, doctor Goldstein, for your excellent presentation and for sharing your in-depth experience with our audience.