Good evening, everybody, and welcome to the American Society for Gastrointestinal Endoscopies webinar. My name is Ed Dillard. I'm the Chief Publications and Learning Officer at ASGE, and I will be the staff facilitator for tonight's presentation. ASGE is very grateful to our presenters and our moderators tonight. I'm looking forward to this presentation on novel duodenoscope and reprocessing technologies. As always, for those of you who have participated in ASGE's Thursday Night Light webinars before, our webinars are archived on our learning management system, GILEAP. Tonight's webinar will be posted in probably the next couple of days, and you can access that at www.learn.asge.org under webinars. Later tonight, after tonight's webinar, I will email all that have registered and participated in an evaluation link. It only takes a couple of minutes to complete, and we really do greatly appreciate your feedback. So, if you could take a little bit of time and send us your thoughts, that would be greatly appreciated. Thank you for that. So, let me get into tonight's presenters. We are so honored to have master clinicians and endoscopists, Dr. Michael Coachman, who is at the University of Pennsylvania Health System, and his colleague and master endoscopist and clinician, Dr. Adam Slavica, who is at the University of Pittsburgh. Dr. Jennifer Marenke will serve as our moderator when we get to question and answer after tonight's presentation. We would welcome your questions. Please use the question box in Zoom, but I know some people will use chat box. We will be monitoring both, and we'll get to as many of your questions as time permits tonight. So, we're going to kick things off with Dr. Michael Coachman, and I'm going to turn things over to him. Welcome, Dr. Coachman. I'd like to thank the ASGE for sponsoring this series and covering really important topics for practice. I'd like to thank Jen Marenke for the invitation to participate, and I'm thrilled to be back with Adam Slavica nearly in the same room, though we are all in the same state. What I want to take you through is the first part here of talking about endoscopes and the paths forward, and I'm using the plural there because there are potentially multiple different options for us as we move forward. I have some disclosures for you, which are up on the slides there, and then some pertinent other disclosures. I'm a member of the FDA GIGU device panel. I just finished with the AIME WG84, Working Group 84, which just put out a paper on endoscope reprocessing called the STS-91, which I'll mention and we can discuss a little bit later. I'm also a former member of the CDC HCPC, which looked at some of the early cases and recommendations for duodenoscope management when the cases were rising in 2015, 2016, 2017. My goals for this evening and what we'll discuss with the panel are to help you understand the complexity of the cleaning of elevator channel endoscopes, gain an appreciation of different paths forward, and also to help you appreciate the response of the GI societies to this with the understanding of why the recommendations that we've made are the ones that have been publicly taken. The problem overall is pretty simple, and without getting into the gory details of each individual infection, the real goal is to avoid patient-to-patient transmission of any potentially infectious material. I think that it's shown very nicely in the published literature that the legacy devices from basically the three manufacturers of duodenoscopes in the U.S. were not effectively reprocessed routinely. We're not going to get into the gory issues that arose with those devices but talk about the paths forward, but we can discuss that there are design factors, there are process factors in the reprocessing of the devices, and then human factors that occur whenever there is any interface between a human with a process or a device. The effectiveness of our solutions is really absolutely critical. The single largest threat facing the practice of gastroenterology and gastrointestinal endoscopy is the loss of public trust, and that trust no question was abridged in the early component of the evaluation of this duodenoscope infection issue, but we have to be very careful with the paths forward that we are stewards of our patients and their experience. Having said that, we need to really have a good assessment of the effectiveness of many of the solutions that we put forward. We need to deal with public disclosures and public relation battles that occur when infections may occur. We have to be stewards that are financially responsible for not only our own practices but for the overall cost of medical care and for the potential outlay that our patients have to have, and we also very clearly need to ensure that bad science and emotions don't rule the day and that we make recommendations based upon clear evidence and that anything that's a gray zone we recognize as a gray zone and don't delve into that as far as an absolute must or should. So various solutions have been promulgated, and that will really be the meat of tonight's conversation, and that will be really brought out by the queries that Jen will throw at Adam and I. The duodenoscope changes that have occurred are absolutely critical. Single-use devices and partially disposable devices have clearly entered the market, and the legacy devices are, for all intents and purposes, obsoleted by the FDA. There are other devices that we can also talk about that are not necessarily available at this time in the U.S., and there are a number of different potential solutions which we can discuss. As you know, for the disposable parts of the duodenoscopes, there are potentially end cap removability and disposability, elevator removability and disposability, and then there are also storts, for example, has a device where the shaft itself can be removed and replaced, and others are also looking at more than just the disposable end cap. The ultimate change would be a single-use disposable device. Again, we will give you our opinions and comments later on as far as what we think about these. Reprocessing technologies are changing. Things are not stagnant. It may not be obvious every day, but there are automated endoscope reprocessors that have had FDA approval. There are different ways of looking at cleaning of devices, potentially sending those out and having certified cleaning. There are some really novel technologies that result in channel scrubbing. For example, there are different hydraulic properties of solutions that, when placed under pressure, can actually remove biofilm from the channels of devices, and we can talk a bit about gas sterilization beyond ETO, including other potential peroxide sterilization techniques, but all of these require effective cleaning of the device prior to sterilization because sterilization will not always nor routinely overcome dirty channels. Other novel technologies are in the works and will potentially be available in the future as they develop and obtain FDA clearance or FDA approval. Concomitant with all of these different solutions is really a need, no matter what, if for all of our devices, to have a QA, QI program, which has been promulgated to potentially include ATP, borescopes, and cultures. I will say that leading into some of the conversation about the society's stances, especially in regard to the AMI guideline, is that ATP has not been FDA approved for the single use of ensuring cleaning of the endoscope. Borescopes do not have a very clear routine usage because there is not a clear pathway to understand the potential abnormalities that may be detected, though they may be part of the QA, QI program. Cultures are clearly part of any of the QA, QI programs for any of the reprocessible devices, and that is contained within not only the FDA but within society guidelines. A number of you may have seen recently press releases concerning the GI societies voting no on the STS-91, which AMI put together. The GI societies, along with the surgical societies, meaning ASGE, AGA, ACG, AASLD, SAGES, and ASCARS, all participated at the table with STS-91, but had significant reservations about the ability to implement that guideline and also concerns about the levels of evidence. As I mentioned earlier, we have to have evidence for recommendations. With that, we relied on the individuals, meaning practices, institutions, to make a determination as to what guidelines they wish to follow, and that is, in our instance at my institution, the multi-society reprocessing guideline led by the ASGE and approved by the other societies that I mentioned. In addition, there are AORN guidelines, SGNA guidelines, but almost everyone has to have a citable guideline for certification of your unit to demonstrate compliance with that. Responses from the GI societies have been measured, and we wish to maintain a level of evidence with our responses, meaning that we feel that every practice needs to assess its risks and resources available, not only for potential reprocessing, but for potential disposable devices to ensure that it will be fiscally responsible, and to also look at the QA and QI of reprocessing, which, under a number of the guidelines, will include a standardized culture methodology. The FDA has been clear about the transition to new and novel devices, which I had mentioned earlier and which I'll show in an upcoming slide. Jeff Shearn, a couple years ago, did clearly make the pathway clear that duodenoscopes with disposable elevator components represent another major step towards lowering the risk of infection among patients who undergo procedures with these devices. Having said that, there's no question that disposable devices also fit into this paradigm, and the FDA has issued additional directives as recently as earlier this month to further support the transition and essentially wanting the transition to occur in a faster pace than it has heretofore occurred. This data is what drove the April 5th recommendation from the FDA. The left side, which is deliberately dark, looks at the data of the 2015 522 study. The 522 studies are mandated by the FDA for post-marketing surveillance. They had the three manufacturers survey devices to ensure with culture data that they had an idea of what the baseline was. I have had a number of conversations with these companies and with the FDA, and there are potentially issues with the data, which led to a follow-up study which commenced in 2019 and is still ongoing, which has looked at the current generations of devices from the three manufacturers. Preliminary early data, again, not barely more than half of the data was available for Fuginon, showed a 0.5% high-concern organism result. This is not fully adjudicated or clean data, so there are potentially questions surrounding whether or not the high-concern organisms were from the same scope or not. Nonetheless, that data is encouraging compared to the potentially up to 16%, if I remember correctly, from the original 2015 522 study. The other two manufacturers had not had data in at the time that the FDA reviewed it. The FDA felt that that data was sufficient enough to make the recommendations that will follow, which are part of their April 5th communication. They included, and this is their direct verbiage, use duodenoscopes that have disposable components or are fully disposable if available at your facility. Disposable components may lower but not eliminate risks of infection. That number, as I mentioned before, was pegged right now at 0.5%, but it's not certain whether that will be higher or lower. If your facility uses fixed-end-cap duodenoscopes, transition to newer models of duodenoscopes that have disposable components or are fully disposable. That's extraordinarily clear and straightforward. The next point was follow the manufacturer's instructions for the assembly of the disposable caps, which makes sense. Also, develop schedules for routine inspection and periodic maintenance in accordance with duodenoscope manufacturers' recommendations. Ensure that our staff are meticulously following those reprocessing instructions. Institute a quality control program that includes sampling, culturing, and other monitoring methods, and then consider reprocessing the supplemental measures such as sterilization or use of a liquid chemical sterilization system consistent with the device's labeling. The key issue is the monitoring if you're using reprocessable scopes, and there are a number of different potential options, and the CDC HCPC Microbiome Working Group recommendations are available at this URL. The FDA listed very clearly the available scopes. Somehow my color ended up changing here, but fully disposable scopes that are currently marketed are the AMBU device, the BSC device, and then from the three legacy companies in the U.S., currently available are a scope from Fuji, one from Olympus, and two from Pentax, which are available for purchase or trade-out. And I'll stop there, turn this over to Adam. Adam. Hi, I'm Adam Slifka. In terms of disclosures, I take no consultancies from any industry. I do IRB-funded research with Olympus and Boston Scientific, and thanks for that fantastic and up-to-the-minute introduction from Mike. There's some redundancy with the beginning of my talk, so I'm going to run through things more quickly in the beginning because there has been some redundancy, but I put here what I'm doing for you guys is really taking you on a personal journey because, as you can see on the top here, we were involved starting in 2012 in one of these CRE infections in which a number of people got sick and several died, and you spend a lot of sleepless nights and you look at everything you do, and so this became a personal journey for me. As you all know, and as Mike pointed out, the old school was you do three things. You do point-of-use processing, which is your first step, your wiping and suctioning that has to be done in the room. You go to thorough cleaning, brush and scrub, a manual component, some automated components, and then high-level disinfection in an AER, and we know now that that's not enough, right? What's been this timeline? You know, we've been finding little mini-outbreaks and going back to 1984 with Pseudomonas and then up in 93 with Pseudomonas and Enterobacteriaceae, and there have been proposed mechanisms in the lower boxes as to exactly what went on, but really high-level disinfection is supposed to be that nothing is surviving from patient A to patient B, and we were failing. These MDR organisms, this isn't a U.S. problem, this is worldwide, and it's on all continents. We don't know the magnitude of it, but we just started a three-continent study that I'll mention at the end that we're trying to find out what the prevalence is. There's lots of regional variation. It's in just about every state and every country in Europe, and it's also been reported in Asia, and as Mike was alluding to, public confidence, you know, when things go from medicine to politics, it's never good, and when you open up a senator's, this is Patty Murray's report that sits on my desk that I open from time to time, and you read about your hospital and delayed reporting, etc., etc., it's not a very comforting feeling, and I'm not sure that it leads to the best decision processes as we mitigate through this. So, once these outbreaks happen, starting in 2012, our outbreak was almost to the month the same as Erasmus Hospital in the Netherlands. The CDC ended up reviewing and responding. They issued new cleaning instructions. The endoscope manufacturers were fined hundreds of millions of dollars. For some of them, their C-suites in the United States were wiped out. The most common AER, custom ultrasonics, was pulled from the market because of a lack of validation data, and then the FDA and CDC, which had totally separate culturing protocols, decided to come up with a uniform protocol, which was good. The FDA began to mandate culturing studies that Mike showed you already, but they made an important statement, which was that high-level disinfection alone is no longer adequate. Unfortunately, back then, this was in 2019, Mike can correct me if my dates are wrong, they called for one of four mitigations, high-level disinfection twice, which we know doesn't work, culture and quarantine, where you culture every scope before you allow it back in, is probably the safest, although cultures are obviously not perfect, but it's definitely the most expensive, and you have to more than two-fold your fleet of scopes. ETO, post-HLD, which we adapted throughout a 40-hospital health system at a cost of over two million dollars, with new generation low-volume gas machines, doesn't work, I can tell you that by leaking some early data on our cultures post-ETO, and it gets to Mike's point, you can't sterilize something that's not clean, and then liquid cold sterilization, that with some of the newer AERs, longer run times, higher temperatures, generally tough on scopes, not good, a lot of data. What happened in 2020, the FDA encouraged manufacturers to redesign duodenoscopes. Mike went over that very nicely. And they also encouraged manufacturers to develop single-use scopes. Olympus is working on one. Boston Scientific came out with Exalt, and Ambu came out with the scope. I've used all of them, but I got involved from the very beginning with Boston Scientific as one of the primary investigators. And so I'll share with you what we did, our published data, how we approached this. And to quote what Mike said, is this good science or is this bad science? This is registry data. So Boston likes to get new technology in the hands of experienced people and get feedback, just like with colidocuscopes and other devices. And this was their effort to try and not dive into the pool, but to dip their toe in. And for both companies, I can tell you I was so amazed at how quickly they could put something in your hand that, with all its good and bad, you could actually complete cases with, which is, to me, absolutely amazing. So I can tell you, with my experience with Exalt, the study cadence. We did a bench study, randomized trial number one. We then did our first human use in a small series. Then at the behest of the FDA, we did a second randomized controlled trial, and then we did our second human series. And I'll present those four studies for you very briefly. And we're in the middle of a very big multi-center international study, as we speak, using the commercially available scope. And rest assured, there are iterations that are improved. So this is our bench study that Andy Ross was the lead author on from Virginia Mason. And what you see on the left there is the model. And it looks sort of like a dumb endoscopic simulator. We call him Timmy. I don't know why. The design, the engineer, I think that's his kid's name. But the interesting thing about that, Timmy, is it costs $35,000 to make. It's 3D printed from sagittal and axial cuts of a human on CT. And so all of the relationships between the mouth and the stomach and the papilla are very anatomically correct. It's done sort of in the left lateral position, which may not be the way everyone does ERCPs. It had a single orifice in the ampulla in this version. And basically, we looked at four simulated tasks with EXALT and with Olympus Pentax and Fujinon scopes and found that all the tasks, guidewire locking, plastic stent placement, metal stent placement with subsequent removal, and sweeping a basket in the duct could be done without differences in time to complete the task. We then went on and started a small case series. And Raman Muthusamy from UCLA was the lead author on this study, the first human studies with EXALT, a case series of 60 patients, seven experts at six academic medical centers. Our aim was to prospectively, consecutively enroll patients showing up for ERCP using the single-use scope. We looked at overall satisfaction on a scale from 1 to 10. We looked at ratings on 14 ERCP maneuvers, either not preferred, neutral, or preferred, and 23 performance characteristics, again, not preferred to now five being equal to, not inferior to. We all did 13 roll-in cases where we just dropped the scope, lined up the papilla, took it out, and then finished the ERCP with the reusable scopes. And then we went on and did the 60 patients. If you look at the clinical characteristics between the roll-in of the 13 and the 60 cases, there was really no significant difference. And note that in this small series of 60 patients, we had a reasonable mix of ASGE complexity. And in subsequent studies, we really got more grade 4s. And in this early study, only one patient was an ASGE-complex grade 4, but plenty of 2s and 3s. The median overall satisfaction with the single-use scope was 9 out of 10. We had 177 ratings on the 14 maneuvers and found that we felt neutral about it in 90%. Three patients, it was preferred. In 14 patients, it was felt to be inferior. For nine patients with one or more not preferred ratings, the most common reasons were cannulation or elevator issues or stent placement and removal. And this just shows you the ratings, all 4s and 5s of all of these, starting from ease or ability to intubate the esophagus, suction, lining up the scope, passing to the papilla, stabilization, et cetera. So in summary, expert endoscopists reported good overall performance of a single-use through a DEMA scope. The low ratings were good areas for the engineers to modify scopes which are in process now. Now, the FDA came back and they said, OK, so really good, experienced endoscopists could do that, could do these procedures. What about less experienced endoscopists? And we're concerned, since the elevator was brought up as maybe not being as optimal, that we're going to see more inadvertent cannulations of the pancreas, which is going to lead to more post-ERCP pancreatitis with less experienced endoscopists. So we flew Timmy to Pittsburgh, and I took my therapist at Pittsburgh, and I took my therapeutic faculty and fellow, and we modified Timmy to have a bile duct direction and a pancreatic duct direction. I'm going to save you some of the details. But we looked at four tasks again, and we looked at two people that had done over 2,000 ERCPs cumulatively, two that had done between one and 2,000, one that had done between 200 and 1,000, and one of our fellows who had under 200 ERCPs. And we looked at the endpoints and subjective measures. And just to save you for time, the experienced guys did things a little bit quicker, a few seconds quicker, but there was no difference. And we did not see in this crude model more pancreatic cannulations. But it did lead us to our second large study clinical trial in which we, instead of just using the seven very experienced endoscopists, we allowed now some less experienced endoscopists who were still all therapeutically trained and while working at tertiary centers to get their hands on the scope and start doing procedures. Our recruitment was interrupted by COVID. This was January to February. We put 50 in. And then May to July, we put another 50 in. And then September to February 2021, we put the last 100. So we put 200 patients in. We looked at completion rate, crossover rate, satisfaction scores, serious adverse events, which are sort of related to standard post-ERCP complications but also include some other things that we normally wouldn't consider a complication, like a sore throat after an ERCP, completion time, number of cannulation attempts, and again, the ASGE grade of complexity. We screened 283 people and got 2 thirds of them to participate and 95% of them completed and had seven-day follow-up. The crossover rate was about 10% to the reusable scope. Seven cases were not completed. Three were crossovers. Two were changed to EUS-guided access. And two were aborted and patients rescheduled. There were about a quarter of the cases were considered difficult common bile duct cannulation based on how we define that with number of attempts and time. And 5.5% of patients had concomitant cholangioscopy through the single-use scope. Looking at the data, again, very similar to the previous study, the smaller study with a mean age of 60, half-female, typical indications for the ERCP. 2 thirds of the patients already had an ERCP. And usually with a sphincterotomy, that's reflective of a tertiary referral population. And you see now a really nice spread of grade 1, 2, 3, and 4 in terms of procedural complexity. Unfortunately, from a statistical power standpoint, the highly experienced guys did most of the cases. But the less experienced still did 40, which is a reasonable number. And interestingly, the completion rate, the crossover rate trended to being higher in that more experienced endoscopist, probably because the younger guys just wanted to persist and finish up. And the older guys were like, hey, I want to use the reusable scope. The median overall satisfaction was similar between experienced and less experienced. The adverse event rate was similar. The procedural time was similar. The number of cannulation attempts was identical. And the complexity grade was very similar between the more experienced and the less experienced. And when we lump the easier cases, the grade 1 and 2, to the harder cases, grade 3 and 4, the only difference we saw was the procedural time was twice as long for the more complex cases. And that was highly significant. The crossover rate, completion rate, overall satisfaction, the number of cannulation attempts were not different between the easier and more difficult cases. In terms of the image quality, I find it to be quite acceptable. Do we have NBI? No. But these are just three typical, not best cases. They were all videos, but I had problems embedding it for this. But this just shows you that you can see your landmarks pretty well. And the illumination is really quite good. And when you pass a device out of the elevator, you do not get that bleaching that you can get with iris taking some time to adjust to cannulas like you can see with some of the reusable scopes. Serious adverse events, 6.5%, which is very acceptable. But look at acute pancreatitis, 1.5%. This was important data for the FDA. We did not see increase. This is a very acceptable rate of post ERCP pancreatitis. Bleeding, 2.5%, cholangitis, 1%. And most notably, we did not see any perforations and still haven't seen them in the experimental group, cohort. I did want to draw to your attention this, which the company kept all the investigators apprised of what was happening and what was being reported to the FDA in the commercial use. So while we're doing all these studies, the sales group is selling these across the country. And a higher than expected report of esophageal perforations in the clinical experience was observed. And we're talking about a couple of thousand cases. And so the incidence of esophagus perforation was 0.14%, which we thought was too high. Why is this? Well, the insertion tube is stiffer. And in addition, the dials don't automatically return to the neutral position. So after you bow your big dial towards you to get around the tongue, you really have to force the big dial back to head back posteriorly. In addition, it appears, even though we're not talking about large numbers and I can't apply good statistics to this, that general endotracheal intubation is an independent risk. And the supine position, I would say these may be independent risks. So the company responded through mitigation efforts by sending out written warning going over this. They created a teaching video that was done by Dr. David Carlock. And those have to be viewed and the documents signed off on before they'll sell them to you. The dials are being redesigned. But they haven't been FDA cleared. I saw them last week. And the shaft is being made more flexible. Again, hasn't been FDA released yet the latest iteration. So in conclusion, endoscopists with varying levels of procedural experience can use these scopes to complete a lot of ERCPs, most of them including complex procedures. Crossover rates, cannulation attempts, and user satisfaction are similar in the highly versus less experienced endoscopists. I want to draw your attention to two trials. One is a 500 case international multi-center study that I'm the PI, study PI on. These are being done in Europe, in India, in Scandinavia. And we're about halfway through. The second study, which I don't have on here, is called the PREVENT study. And this is also funded by Boston Scientific. But it's not a scope study. It's a microbiologic study that's being run out of Marco Bruno's lab at an Erasmus Hospital. And we will be looking at what the incidence of MDROs are in patients presenting for ERCP on three continents. We're looking in Europe, in India, and in the United States. So we're really excited about that because we think that represents the denominator. And it'll be very useful information. As Mike called for more data, that's what we're trying to do. One of the questions people ask me are, are we using it clinically? When I was aware of the esophageal perforation rate that was popping up, I froze it at our 40 hospitals. But I'm slowly releasing it as people are going through the mitigation. In our lab, we use them for known carriers of MDROs and immunosuppressed patients that are expected to undergo multiple ERCPs. And with that, I thank you all. Great. Thanks so much to Dr. Slipka and Coachman for outstanding presentations. I have a number of questions that I'm hoping that you'll answer. And so my first question, since we just finished talking up a lot about the data from the Boston Scientific Single-Use Scope. So this question is directed to Adam. And so both of the studies, the large study that you published and the study prior from Muthasani that you were also involved in, there was a substantial crossover rate. So when I think about potentially converting our unit to disposable scopes or what would be the perfect kind of scenario for having solely disposable duodenoscopes, one of the advantages would be to decrease the cost associated with reprocessing. And when you have a fair amount of crossovers, you still basically have a need for those traditional scopes and that whole reprocessing setup. So what do you think about that? Yeah. So the answer to that is maybe you do. We did not create an algorithm for when people crossed over. And in fact, it was very interesting. If you took one doctor out of the study, the crossover rate reduced by 60-something percent for the group. So people's thresholds were very different. And I can give specific examples. For example, the first crossover that Andy did, he told me he could not get into the bile duct using his standard approach and was going to do a needle knife and said, you know what? I better fail with my old standby before I escalate risk and do a needle knife. And he failed with the disposable scope, with the reusable scope, and then did the needle knife. So these are typical examples of what causes a crossover. Doesn't mean that if this was the only scope that you had in your armamentarium, you'd run into major clinical problems. But you've got to remember, this was the first time people had put their hands on this. And so the threshold to cross over, we probably could have protocolized it a little more tightly, but we didn't. This was a registry. And I will say that, interestingly, some of the senior guys, the minute something wasn't going perfect, they'd say, give me back my other scope. And that counts as a crossover. And some of the younger guys seemed to be persisting a little bit longer. But that's also why, with a brand new device, you're not going to just totally switch over until you're comfortable that you can hit the performance that you would hit with the other scope. I can tell you that I've done about a dozen cases with the AmbuScope. And again, very pleasantly surprised at how close it is. I don't think it's, just like Exalt, I don't think it's perfect. I think there's lots of work that needs to be done with these scopes. But again, given that they're just out and they're competing against 70 years of development and design, it's pretty impressive that this happened over a four-year period. I will say, when the head engineer of Exalt, we were drinking some beers. And he said, Adam, tell me the truth. I mean, do you like it? I mean, what's the difference now that you've finished enrolling and you've used as many as anyone in the world? What's your take? And I told him, you know when you go to a wedding and you put on a pair of dress shoes and you're dancing and dancing and your feet are killing you? And then you come home and take those shoes off and put your Nikes on? These reusable scopes are my Nikes. They just, they feel better. I feel better using them. And so, but that's all a matter of getting accustomed to them, letting the engineers work on them, design them, take feedback from people and make better products. I mean, thanks for that input. And kind of in line with that is, looking at your data, the majority of patients had already undergone ERCPs and probably had sphincterotomies. And when I think about complications of ERCP, the biggest complication is really post-USB pancreatitis. And a known risk factor for that is difficulty cannulation, you know, in cannulation. And so a lot of those patients, you know, were sort of not, you know, not the most, in some ways the most challenging or delicate aspect of the procedure was sort of taken out of the game. So I'd be really interested to see with, you know, native papillas, you know, A, you know, your rate of post-USB pancreatitis was very low. And that's, so not really indicative of what it is in the community. And I'd really like to see kind of with, you know, community docs, how they're navigating this. I don't know, Mike, if you have any input about this topic. Yeah, so I haven't used the Exalt device in vivo. I have used the Ambu device. And the Ambu device that I've used has been in pediatric cases, as low as actually nine kilos. And I would say that the critical issue is to understand these devices. And I think Adam was hitting at that, you know, personally, I prefer ASICs as opposed to Nikes. So we'll argue over that. But the critical thing that Adam was bringing up is the comfort level that you have understanding the operating characteristics of the device. As I've said to companies, when they hand us different devices, it's not when you hand the device to me or to Adam or to some of the people that I see who are in the chat. If you hand it to Brett, we'll get that case done. The question is if it's something that we're going to feel ergonomically comfortable with, clinically comfortable with, but as Adam was saying, the younger people who may not have that ingrained feel may be more adaptable to a slightly different device. I will say, for example, on the Ambu device, it is much more flexible than the Exalt. The fluoroscopic appearance of the end of it reminds me a little bit of the alien under fluoroscopy because you can't see exactly where the end of the tip is. Adam's laughing, I think he knows exactly what I mean there. And then the ergonomics of the handle are critical. I expect a certain feel, I'm not getting that. I expect my thumb to lie in a certain position and if the elevator extends too far across, I'm not used to it moving back and forth. The return of the device is also critical as is that angle and the location on the screen and relative to the torque that we have on the device. And those are all things that can be tweaked, they can be adjusted. But the question that I have posed to the companies is why are we necessarily trying to reproduce something as opposed to saying, what should it really be? Should I have to move my thumb linearly to affect a change at the elevator or to preserve my thumb, can't we change the ratchet ratio so that it will either quickly ramp up or down? Why, for example, do I have to hold the scope in a certain way, which may or may not be comfortable? So there's a lot of tweaking that can be done. There is a learning curve to these devices. I think Adam clearly hinted at that. They're usable to a point. I'll say the pediatric cases that I did, 50% crossover and we weren't giving, or I wasn't giving up easily but those were altered pancreatic anatomy where I had to have a certain line and if it's not lining up for me to get into essentially aberrant anatomy and a 10 kilo kid, we're gonna end up switching over, I need the room. I will get to Jen's point on the native papillas which are less common in the tertiary centers and more common in the community. The elevator, the patents around the disposable scopes elevators are pretty tight. And so they had to come up with different designs and they're very different. The throw of the device, the angle with which it presents the amount of lift that you get or the perceived amount of lift. And the way I cannulate a native papilla with either an AMBU or an exhaust scope is very different. You know, like, you know, I like, I don't like using wire guided papillotomes for all my cannulations because I'm a dinosaur and I was trained just to do catheter cannulations and to do the cotton kiss. Well, if you're doing the cotton kiss if you're actually bringing the papilla to the catheter and roofing it to get in a bile duct the elevator has to lift you up and you can't do that with these scopes. And you have to use a papillotome more and more to help you get a more elevator function. So you do have to change what you do. I'm a little unique because my first 500 ERCPs were on Fuji, first generation Fuji where the elevator went up to the 50, you know 50% of the field and no more than that. And then I came to Pittsburgh and did a couple of thousand ERCPs with Pentax and then we switched to Olympus. So I've grown up with all the different devices and learned how to, you know, they're all a little different and these one single use scopes are definitely different as Mike pointed out. Well, thanks for that input. This question is directed to Mike. So what are the, and it's from an audience member what are the known complications associated with disposable end caps? So I would say known complications as opposed to events. Last I looked directly at that, there was if I remember correctly in Europe, there were a couple that had come off during retrieval but I don't believe that there were any complications related to that other than coming off. I have used those in models. We have them sitting currently in our storeroom awaiting all of our certification to occur from our biomed people and the training of all of our techs to occur. We're going to use those devices. Greg Ginsburg and I looked at it and that's our pathway. We're not really worried about the end caps coming off. Those are really firmly attached in the current iteration of the Olympus device. I believe the issues that had occurred may have been with the Pentax device in Europe, as far as I recall. I don't know, Adam, if you have anything to add to that. We're using them. I've done hundreds of cases with them and we haven't had issues. I was aware of one time when a doctor grabbed the scope and put it down before that cap was put on. And the nurse who said, wait a minute, I'm wasn't ready. There were some erosions in the back of the throat from the metal going down, but no bad clinical outcomes. So, and we haven't had any come off yet. We haven't had any issues either. Dr. Peterson mentioned in the chat that there are numerous mucosal linear tears when suctioning during removal through the esophagus as a complication. Oh, another question I have actually relates back to the disposable duodenoscopes as a whole. And the two questions I have relate to the environmental impact and also supply chain issues. Because right now in our unit we have ongoing supply chain issues and I can't always get the wire that I want or I have a couple of tomas that I like to use but I wouldn't want to be in a situation where I need to use a disposable duodenoscope because I don't have an alternative and can't get it. How likely is that scenario? And I'll posit this to Dr. Peterson. I can't answer that because I'm sure they have more than they've sold already. So, but I, cause sales are lagging behind projected volumes. The environmental impact is a massive concern. More in Europe than in America, but also in America. The companies are coming up with recyclable programs so you can send them back and AMBU's materials are supposedly green materials in terms of degradation over time and so forth. But I think, well, Mike, do you have any more info on the environmental impacts? Yeah. So I was at a meeting, I believe it was two weeks ago and both AMBU and BSC indicated it was one disassembly vendor for both of them. I will say that the environmental impact issue was one that was queried extensively by the FDA at an open panel meeting. And, you know, Heiko Paul had a paper that was out I believe last year, which estimated based upon the overall environmental impact, about a 40% increase in landfill waste from endoscopy. And GI already contributes as number three contributor to waste. And that was net of the reprocessing environmental questions. The four societies have looked at this and are looking at it as a green initiative. The journal I added actually had a volume that I dedicated strictly to green endoscopy because of the potential environmental impact of what we do. There is a strategic plan from the ASG, AGA, ASLD and ACG with outlines over the next few years to be able to really look overall at the environmental impact of what we do. It's really something that is critical and will become more critical. Thank you for that input. I just posted to the chat the PubMed citation for that article. And then, you know, one of the other key factors is the cost of the disposable duodenoscopes. And so Mike, can you speak to the current state of how this is covered and how it may be covered in the future? I'll take a quick stab at it, but I think Adam has some practical comments on it within his system. He probably has better numbers. But really the question boils down to a pass-through for Medicare and when that pass-through expires, you know, it's a potential heavy economic burden which may be essentially a cost shift. Somebody's gonna pay for anything that we do and that's gonna come out of our tax dollars or it's gonna come out of other funding that Medicare will shift or restrict. So it remains to be seen in the long haul how this will impact. But I think, Adam, you know, as far as the daily activities of trying to sort out who gets a pass-through and not, do you wanna comment on that? Yeah, I mean, as Mike said, the pass-through code is great, but what do you do when it expires in 2023? And hopefully they say the insurance companies will respond, but, you know, don't hold your breath. We got inpatient, now patient Medicare. The pass-through codes are so complicated. How you get, what determines what you get. And it's not just simply a number. It has to do with your charge to cost ratio. And it's really complicated, but we have a financial team that's tracking it. And I can tell you that if, you know, Medicaid pays for nothing, but if you, and commercials are beginning to warm up and come around, and we've gotten some huge payments from commercial. What they told me as of last week was our average reimbursement, including the zeros and the high ones was, it came out to about $1,600 average, which is probably close to enough to cover the Ambu scope and not enough to cover the Boston scope. Prices will drop. The Bostons are all handmade. Once that's automated, prices will drop. Competition's great and prices will drop. But again, this certainly is significantly more expensive than any of the estimates that I've seen for reprocessing costs. The companies like to tell you how much you're spending on reprocessing, but when you micro-cost it down, you know, carry around, you know, about three to 400 bucks, including HR, you know, human resources and so forth, at least in our lab. And we do ETL. Great, so that brings me to my last question, which will be posed to each of you. Adam, you sort of touched on it already, but what's your current state for using disposable components of the duodenoscopes? You sort of mentioned who the disposable duodenoscope is for, the single-use scope is for, and then your current kind of disinfection paradigm at your institution. Yeah, I mean, right now we're doing single HLD and ETO. We're accumulating a lot of culture data, both initially as part of the 522 study, but even in our own internal studies. I'm going to leak some news to our esteemed audiences that EUS scopes are as bad or worse than duodenoscopes. I'm just going to tell you that, at least in our hands in meticulous culture studies, and we're also ETOing our EUS scopes. We're reserving commercial, we're reserving the commercial use of disposables to known MDROs and immunosuppressed people that require multiple ERCPs. People in my lab and myself, we like to grab 10 French cents and pull them through the channel. And two years ago, Dave Lichtenstein at BU told me that's one of the reasons where we're seeing these skibes and problems in patients with MDROs. And in our outbreak, all our bad outcomes were in liver transplant patients that had arterial catastrophes. And we were trying to keep them alive so that they could get relisted and get a new liver. And we were cleaning crud out and putting stents in. And once those people get an MDRO, they're doomed, they're off the list, and they're doomed to a bad outcome. And in all of those patients, we were pulling stents through. So I could almost see making a cogent argument if you're doing stent changes and you're pulling stents through the channel, use a disposable scope. They actually, in my humble opinion, come through even easier than with the reusable scopes. But that's sort of our clinical use in our hospitals right now with the disposable scopes. So our paradigm is significantly different. Our paradigm has been culture and hold. So we will culture Friday and then reuse starting Monday after they clear. With that, we've published our data. The cost is there, but is not prohibitive at all. Often people that I talk to about culture techniques, the problem is to get your lab to run those cultures because they're not clinical cultures. So the lab, unless they can link it off into a patient, won't run the culture. And you may have to have a high level discussion about that. We have seen occasional low concern organisms, which are almost all skin contaminants and are related to either new people starting to do the culturing or people that were trying to do single person culture, which really doesn't work very well. We are going to transition to, as soon as we can get the training done and get everything certified, the disposable cap Olympus scope. With that, going back to the culturing, we're also culturing our elevator channel duodenoscopes and have seen no difference there. We've had a lot of QI, QA work with our reprocessing. We have a central reprocessing group that's dedicated only to the endoscopes. And we feel that they've been adequately trained. One of the things I like to really have a good back and forth with the two of you and anybody in the audience is I philosophically have a problem with segmenting out certain patients to have the disposable scope for a couple of reasons. One, our data is pretty clear. We're a Sentinel site for MDROs for the CDC. So we have to report every one of our MDROs and we retrospectively go back and prospectively follow them. At the time of our initial paper publication, 17 of our CRE patients, we pulled all of their records and none of them had had in the preceding three years an ERCP. And I think you have to either believe and prove that you have effective reprocessing or you have to say you don't have effective reprocessing. From a philosophical perspective, if I don't think I have effective reprocessing and I'm worried about the MDRO, the MDRO is no more resistant to HLD than a non-MDRO organism. So I either have effective reprocessing or I don't. And with that, how do you explain to a patient why Charlie, who they may know, got a disposable scope and they weren't getting one? I think we have some significant ethical and thought process issues. Sorry, Adam, to say that, but you and I have had more than a couple of beers and cups of wine together over the years. So let's have that dialogue. No, I'll tell you something. You're not alone in that. I think you have a great point. And let me throw another extreme at you. There are major academic medical centers that are asking the endoscopist to look at the insurance of the patient. If they have Medicare or a commercial that pays, they will get a phone call and say, why aren't you using a disposable scope? We're making money off of that. And these are not bad people. These are people we all know that are good people that are participating in these types of dialogues with the financials in their hospital. The European Ethics Society has adjudicated that if disposable scopes are safer than non-disposable scopes, you must offer them to 100% of your patients. So that is what Mike was talking about. And unfortunately, Mike, I'm jealous because I don't have adequate HLD at my hospital. I know that because I've been involved with every fricking culture study that's been mandated and we're doing a lot of our own. And I know what our failure rates are. And right now, I believe I'm walking on thin ice with the policy that we have. And I'm waiting for HLD to get better. And I'm waiting for disposable scopes to get better and then make a choice. But I agree with everything you said and I don't feel like a monster, but I understand that it's a little compromised. I'd still let you do my ERCP if I need one. You know. But would you want the disposable duodenum scope or would you take the reprocessed one? So- I'd take the reprocessed one. Even in Pittsburgh. All right, well, this has been very enlightening for me, certainly. I hope it's been enlightening for the audience as well. Thanks for answering all of my questions. And I really appreciate you being so candid with your responses and forthcoming. Thanks to the ASG organizers for putting this together. And I'll hand it back over to Ed. Thank you, Dr. Marenke. And I really appreciate your facilitation of tonight's discussion. Dr. Zuleika, Dr. Coachman, it is just an honor for ASG to always have the both of you share your observations and experiences with the community at large. So thank you to the two of you. Just a few closing remarks here is that, again, and as a reminder that tonight's webinar will be posted on ASGE's GI Elite, so that if you need to listen or if you want to share it with your colleagues, please feel free to do so. And the evaluation, I will be sending that out here in a few minutes after we close out our reminder. And again, it only takes a couple of minutes to fill out. We really do take a look at your feedback. So please take a little bit of time to give us your thoughts. We've got some exciting educational activities coming up here into this weekend, actually, is our annual GI Advanced Practice Provider course that's a virtual program. So if you have any nurse practitioners or physicians who would like to listen in on this, that it's a great program that's gonna be offered tomorrow and Saturday. Our next Indo Hangout for Fellows on esophageal strictures will be on Thursday, May 5th. And then Doug Adler will be providing another Thursday night webinar May 12th on if you've been sued now, what do you do? And then it's DDW time, folks. Got a lot of activities coming up at DDW in San Diego. If you're planning on attending some of the ASGE activities, we've got the Train the Endoscopic Trainer Workshop along with our AI Conference Workshop on Friday afternoon. Our ABE group is always putting on their annual meeting on comprehensive care of the patient with obesity. And then we have our Hands-On in the Learning Center. This is a first come first serve basis. It is not ticketed like it has been in past so that you have to sign up and you've gotta show up a little early because those seats will go fast. So take a look at our website for that. And then the postgraduate course is on May 22nd that's both virtual and in-person. And then obviously ASGE's Crystal Awards. It's one of our key mark events that we always look forward to. So we look forward to seeing you all there at DDW in San Diego, whether that's in-person or virtual. And we're excited about that. Again, I wanna thank you all for participating and I hope you all have a good evening. This does conclude our presentation and we hope the information that was shared with you is useful to you in your practice. Have a good evening, folks. Take care.

webinar

ASGE

duodenoscope

reprocessing technologies

cleaning

sterilization

infectious material

disposable duodenoscopes

disinfection paradigms

research

healthcare professionals