We're going to move to our next session, which is going to be quality and safety endoscopy, moving the needle forward, and we're going to have Dr. Rene Williams from the Longhorn University NYU in New York, and we're going to continue with a little bit of eschatological topics. So Rene, please, we're looking forward to your talk, The Dirty Colon, It's Everyone's Problem. Good afternoon. I would like to thank the organizers for inviting me to speak today. So today I'll be talking about something near and dear to all our hearts, the dirty colon. Rene. Higher volume. Oh, I said, is it good? Better? Better. Thank you. Let me see. Okay. Sorry. Oops. Backwards. Those are my disclosures. So a brief outline. I'm going to talk about quality and colonoscopy, bird's eye view. I'll be discussing some bowel preparation scales, risk factors for an adequate prep, the pre-colonoscopy preparation, some best practices to optimize your bowel prep, and give a real world quality example from my own practice and how we cleaned it up. So what's high quality colonoscopy? High quality colonoscopy is a adequate bowel prep. We want to make sure we insert to the maximal extent. We want a detailed examination of the colon based on the recent quality guidelines. That's now eight minutes with an adequate prep with no findings. We want to make sure we identify all precancerous lesions with a curative resection and assignment for appropriate follow-up. Now, why do we have quality metrics? Because a lot of what we do is actually operator dependent. So our quality metrics were put in place to reduce these dependent variables. Specifically, metrics around added number detection rate. In the recent guidelines, we now have two new high priority metrics. Cess-ulcerated lesion detection rate, which is now 6%, the bowel prep adequacy rate, and the CEQL intubation rate. Now, these are not all the quality metrics, just the ones that pertain to my talk. An adequate bowel prep rate is a BBPS score, Boston bowel prep score, greater than or equal to two in each segment, greater than or equal to two. The rate of bowel prep based on the recent guidelines state we should have a bowel prep adequacy within your practice of about 90%. In the past, in 2014, that was 85%. The European Society for Gastrointestinal Endoscopy recommends 90%. They also recommend repeating within a year if you have an inadequate bowel prep rate. Within our own practice, we decide to repeat at next available. They recommend a CEQL intubation rate of greater than or equal to 95% with an ADR of greater than or equal to 35%. If you have some positive fecal testing, Cologuard, or FIT testing, you should be having ADR of greater than or equal to 50%. And as I mentioned earlier, the Cess-ulcerated detection rate should be 6% or higher. So what's a Boston bowel prep score? This popped up on the scene a couple years ago. It is a scoring system that's been validated in multiple studies and also has been tested for reliability. It's a numerical scale from zero to three in each segment of the colon, and you're scoring after you've cleaned the colon. So a score of zero, as you can see on the upper, let's be my right-hand side, is an unprepared colon with mucosa not seen due to solid stool that cannot be cleared. A score of one is portion of mucosa of colon segment seen, but other areas of the segment are not well seen due to staining, residual stool, and or opaque liquid, as can be seen on the upper left-hand corner. Two is minor amounts of residual staining, small fragments of stool, and or opaque liquid, but mucosa of the colon is well seen, lower left, sorry, lower right-hand corner. And three, which is a perfect score, is the entire mucosa of colon segment seen well with no residual staining, small fragments of stool, or opaque liquid. Now, to be completely honest, sometimes I have someone who's between a one or a two, and it's kind of hard to figure out exactly what it is, but here are the actual definitions of the BBPS. The recommendation is to use a BBPS because it's been validated in multiple studies, as I mentioned earlier, and it's a very reliable test or scoring system. The next one I'm going to talk about is the Aronchic. Now, there are actually many different scoring systems for bowel prep, but the Aronchic is one of the more commonly used ones within our field. When I trained as a fellow, we used the Aronchic scale. This is the first scale to be evaluated for reliability, although there's only been one study looking at a reliability, but it's not been validated, and describes a colon pre-washing or suctioning. So we have our good, fair, excellent, poor. Your excellent is small volume of liquid, over 95% of the mucosa seen. Good is clear liquid covering 5% to 25% of the mucosa, over 90% of the mucosa seen. Fair, semi-solid stool could not be suctioned or washed away, but over 90% of the mucosa seen, and poor, semi-solid stool could not be suctioned or washed away with less than 90% of the mucosa seen. Now, I'll say honestly, when I was a fellow, we used this scale, but no one actually gave me the definitions, and it's a lot of subjectivity here. My good may be your fair. Fair, good, excellent may be variable. So I think that's why I decided to actually go over the distinct definitions. So what are your risk factors for inadequate preparation? There are multiple ones. Diabetes, obesity, use of multiple medications, dementia, male sex, low health literacy, and later colonoscopy start time, and lack of a split dose. This is a recent study that just came out looking at a meta-analysis and systemic review for risk factors for inadequate preparation. It was over 154 studies, over 250,000 patients. They analyzed 48 different unique risk factors, and they put them into four different domains, sociodemographic, comorbidity-related, medication-related, and bioprep procedure-related risk factors. And I won't go over every single thing, but what they found, looking at sociodemographic factors, Medicaid insurance, low educational level, male sex, black race, obesity, overweight, or obese, marriage status, if you're unmarried, you have an increased risk of having inadequate prep, but they didn't find an increased risk factor being alcohol use or low income. Looking at comorbidities, they found liver cirrhosis, any psychiatric disease, an ASA greater than three, poor functional status, constipation, diabetes, and prior abdominal pelvic surgery. Medication-related uses were tricyclics, antidepressants, polypharmacy, psychiatric medications, as we are new. And specifically looking at bioprep-related risk factors, if you still had brown liquid coming out, if you had a prior incomplete prep, lack of a split dose prep, and increased bioprep to defecation interval. So now let's talk about the diet. Patients complain a lot about the clear liquid, and having been NPO myself for a procedure, it's not fun. I will honestly state that I was very tempted to cheat, because I figured the anesthesiologist would know anyways, but I didn't. Is this a truth? It's a truth. So this is a meta-analysis looking at your clear liquid versus your low residue diet. It looked at nine studies, and they only looked at randomized controlled trials over 1,600 patients, and they found that there was actually no difference in bioprep adequacy. So a low residue diet versus a clear liquid diet, no difference in inadequate bioprep rate, no difference in adverse events. However, there was a significant difference in tolerability, as expected, and willingness to repeat. But what is a low residue diet or a low liquid diet? Let's talk about that for a second. So low residue or low fiber diet. Avoid any foods made with seeds, nuts, or raw or dried fruit. No whole grain breads. That bullet about the refined white flour is a mistake. I apologize. No raw or dried fruits, no raw vegetables, and restrict foods high in fat. But what can they eat? They can eat cooked or canned fruits, bananas, melons, applesauce, French toast, pancakes, and waffles. So I tell my patients, have some waffles for breakfast the morning before. They're a lot happier. Cooked vegetables, grounded meats, no hard or grizzled meats, and butter, margarine, or oil. So a patient could technically have this low residue diet, and it should not make a difference in their prep. How about the volume of the PEG of the prep that we're doing? So this is a meta-analysis of 11 studies looking at low volume versus standard volume polyethylene glycol. And what they found, and this is looking at 2 liters plus exoerbic acid versus 4 liters of polyethylene glycol. And what they found is that low volume was actually non-inferior to standard volume PEG. And one of the main things patients complain about all the time is the prep that they have to drink, the 4 liters or the 2 liters. And it's not something that's tolerated very well, and they have a lot of side effects, such as nausea. In this case, patients who had the low volume PEG actually had less nausea and less side effects. This is another study looking at two bowel preps after failed bowel prep. So this was a multi-center randomized controlled trial where the endoscopists were blinded. They actually did two different preps. They did 4 liters and 6 liters for patients. So they had 4 liters the night before and 2 liters in the morning off with 15 milligrams of bisacodyl. Or they did 2 liters and 2 liters, which is, sorry, my apologies, 4 liters, 2 liters and 2 liters, or 4 liters the night before, 2 liters in the morning off, along with 15 milligrams of bisacodyl. And they also said, you know what, for three days before, you're going to do a low-fiber diet for two days, and then one day, you're going to have a clear liquid diet. And the primary outcome was the adequate bowel prep defined as a BBPS. Secondary outcomes being your ADR, cecal intubation rate, sesacerated lesion detection rate, tolerability, and adverse events. Now what did we find? What do you think? It was 196 subjects over 4 academic centers. This was done in Canada. There was no significant difference in the bowel prep rate between your 4 versus your 6 liters of PEG. And there was no significant difference in the mean ADR, SSLD, or cecal intubation rate. Again, both regimens were similarly tolerated. And there was a higher willingness to repeat a lower-volume prep, as seen in many other studies. How about split-dose versus single-dose? We've now said standard of care is split-dose preparation. This is a meta-analysis of a split-dose of polyethylene glycol, bare versus single-dose. Five randomized controlled trials over 1,200 patients. Outcomes were bowel prep adequacy, side effects, or tolerability. Again, split-dose PEG increased your bowel prep adequacy, increased willingness to repeat, and decreased preparation discontinuation. So it made the patients more compliant, a higher prep, and willingness to repeat. This was another meta-analysis or analysis of a series of meta-analyses looking at type and dose of laxatives used. So in this one, they looked at different types of preps. They looked at runway time, which is defined as the time between the last drink and the purgative and the procedure, and patient compliance. They had over 7,000 patients, 29 studies. Of course, split-prep was superior in most of these studies. And the difference, they thought, were due to a few things. The runway time, the longer time you have to wait until your procedure is worth the prep, which is interesting. Type of diet, male sex, and the use of four liters of polyethylene glycol. And as, of course, compliance was significantly higher in the split-prep group. So currently, the standard of care is a split-prep for a colonoscopy. Does split-prep make a difference in your pulp detection? That's an interesting thing, right? It should make sense. Another systemic review meta-analysis looked at split-prep and pulp detection, 28 trials, over 8,000 patients. Some trials found that split-prep increased your ADR, increased your advanced ADR, increased your assessed ulcerative pulp detection, but some of the trials actually show that there was no statistical difference in the two. So this particular series of meta-analyses actually had variable results. And how about assistive devices? So this is an assistive device to help with bowel prep during the colonoscopy itself. It's a PureView EVS system. It's an FDA-approved, oversleep, intra-procedural cleansing system, and it uses high-intensity water jets that does not interfere with your actual working channel. So as you can see on the picture, it's an oversleep attached to the end of your colonoscope. It has a setup that has a purge and a cleansing mission. And what you can find is those little four irrigation jets actually shoot out high-volume water and its suctions at the same time. And here is a panel. So this is a patient who came in with a post-polypectomy bleed and had a lot of dark stool staining the walls of the colon. And as you can see on the second panel, B, there are the water jets coming out, and it actually cleaned it to an adequate prep. This is from a case series of three different cases, including post-polypectomy bleed, someone with adequate prep, and I think someone who had a perforation. This has actually been studied looking at feasibility. So there's a few studies looking at this particular system. So next I want to talk about what are some best practices to optimize the prep in your unit. First things first, look at your workflow. Develop a contact and process flow. In my system, there are two ways to get to colonoscopy. Either they see us in clinic, which is a diagnostic test, and they go to the GI nurses, or our primary care doctors can say, this person has a positive fit, this person needs a screening colonoscopy, go straight to colonoscopy. In that case, the nurses, the primary care nurses, are the ones teaching about prep. So look at your own workflow and where in there do you do your prep teaching. That's important to note. You need to offer multiple preparation options for your endoscopy unit. We have polyethylene glycol, we have SUPREP, we have MiraLAX and Gatorade. So one thing is patients need to have a variety of choices. Some patients will say to me, I cannot tolerate the four liters, I throw up, it's not going to work. So it's important to really have multiple options for the patients to choose. Have clear preparation instructions with pictures and videos if possible, and the recommendation is for a grade six video reading level. Sorry, grade six reading level. And use more than one modality to provide preparation instructions. You can do paper, you can do video, have a QR code. Most people throw paper away, to be honest, and everyone has a smartphone. I'm upset even the undomiciled have a smartphone. And I'll tell you something that's interesting. I have friends who are physicians who are not GI doctors and they'll have colonoscopies and invariably I get a text saying, how do I do the prep? Even though they got the prep from the doctors, they still are asking me, how do you do the prep? So it's important to really have a variety of options available. I sent a message to MyChart. If you have something like Epic, use smart sets to prevent gaps or missing information. So when the patients get their AVS or after-visit summary, they can actually see what they need to do. Very important to train your staff to have a standardized way to provide preparation. And specifically educate them during those phone calls. They should be calling them five to seven days before to understand, do they understand the preparation? Do they understand the diet? Do they have the prep, number one? So it's important that your staff, and that in our case would be our primary care staff and the GI nursing staff. If your endoscopy nurses are calling, they should have a standardized ways of also going through the prep. Have it available in languages other than English. About 38% of patients are low English proficiency. So if you only have English, it's going to be very difficult for them to understand or they may have a family member. So if possible, depending on what's in your unit, have different languages translated into the bowel preparation. You should be assessing the adequacy in your unit on a regular basis, at least quarterly for errors or improvement. We haven't done ours in a couple of years to be completely honest with you. And get feedback from your patients. Is it tolerable? What are the challenges you're having with the prep? And review your prepping regimen and instructions. Because as I said a few years ago, we went from a single-dose prep to a split-dose prep. So review those on a regular basis with your staff to make sure you're actually up to date with the most current recommendations. So next I'm going to talk about something we did in our practice called How We Clean This Up. We published this a few years ago. So just to give a bit of context, I work at Bellevue Hospital, which is under the NYU umbrella. It's a safety net hospital. Our patients are mostly non-English speaking, underinsured, uninsured, and ethnically diverse. And if you're looking at different risk factors for inadequate bowel preps, that's our patient population. So we looked at our adequate prep rate over monthly snapshots, and we found that we were having an adequate prep rate of 65.5%. So at that point in time, we said we're going to do the PDSA cycle and do a quality improvement project. So the first thing we did as a group is we started using the BBPS scoring system. As I mentioned, we technically use it at RONCHIC. We trained all our physicians on the BBPS. Then we said we're going to do a split prep because we're still doing single prep. We're a little bit behind the times with the standard NERD teaching. So that was the first cycle, and then we looked at the results. Second cycle, we did an educational booklet in Spanish, English, and Chinese. Why those two languages? In my hospital system, Spanish is the number one spoken language. It's about 40% of our patients are Spanish speaking, and the number two language is Mandarin Chinese. So English is actually third or fourth in our particular patient population. So then we put the booklet in place. So we said, okay, we have this split prep. We have an educational booklet, and this booklet was actually modified from Brendan Spiegel's booklet that he published about a few years ago, and we took it and we actually translated it and modified it to a split prep dosage. This is an example of what we had. One panel is the English, and the next is the Spanish. So we gave this to our patients in the clinics, and we gave it to the primary care nursing staff and the GI nursing staff. We educated all the nurses that as you're going through now, please give these to the patients. What did we find? So when we started, we had an adequacy prep rate of about 65.5%. When we did cycle one, which is incorporating a split prep, we found that that went up to 81.5%. And then the second part, we said let's do the educational booklet. Now there was a little bit of a snafu, so we actually ended up having like a pooled group of patients with booklet and non-booklet, and that was 85.6%. But when we actually separated out the booklet subgroup, we found that our adequate prep rate went up to 93.7%, and it was a noticeable difference in our practice. We did a logistic regression looking at what are the probability of an adequate prep with a booklet alone, split prep alone, or split prep and booklet together. Booklet, 84%, split prep, 85%, split prep at 94%, and booklet together at 94%. So currently what happened is this was a quality improvement project from one of our fellows. They got $4,000, and we printed all these booklets. The hospital was actually quite impressed with the change in prep rates because now we're cutting down on repeat procedures, lower risk for patients. So the hospital took over paying for the booklets, and now it's a part of our practice. That being said, I've noticed lately that our preps are kind of getting a little bit janky again, so maybe we have to reevaluate. As I mentioned, we haven't looked at this in a couple years, which is not the best thing to do. So in summary, I'm going to end that based on current guidelines, adequate prep rate in your practice should be over, greater than or equal to 90%. Split prep is superior to single-dose preparation. There's a lot of evidence validating this. There's no difference in a low-residue versus a clear-liquid diet prior to colonoscopy, and no significant difference in low-volume versus standard-volume PEG. And as I'm thinking about quality in my own space, I'm thinking I just spoke with my chief about maybe starting to do the low-residue diet because I think that's a huge part of the patients in terms of tolerability. And I think for all of us, we just have to really aim to implement our best practices and monitor the progress of quality improvement and quality assurance. Thank you. We'll call you back up when we do the question. Thanks, Rumi. I get the pleasure of introducing our next speaker. Dr. Alan Barkun is professor of medicine at McGill University in Montreal, Canada. And I don't think there's anybody who is considered more of an expert in the field of antithrombotics than he is. He is a senior author on multiple guidelines and publications in research studies. His talk will be Management of Antithrombotics in the Peri-Endoscopic Period, Best Practices for Busy Practices. Thank you very much. Good afternoon, everyone. I'd like to thank the organizers for the privilege of speaking to you today. My master in this is actually Nina Abram. She's done tremendous amount of work, and I would mention her name because she's the co-chair of both the ACG and Canadian Association of Guidelines that I'm going to share with you today. Thank you very much for the introduction. These are my disclosures. So what I'm going to do, I don't have time to go over all the evidence and so on. I'm not going to go over the studies. There's very little data out there in this. But what I'm going to do is provide you highlights, which I hope will be useful for your practice. We'll also discuss first the management of patients in the elective digestive endoscopy, both with regards to anticoagulants and antiplatelets. And then I will move on to how to manage patients who present with GI bleeding while on antithrombotics. So what are the tradeoffs? I think it's important just to say it at least once during the talk. We're balancing the risk of the bleeding event versus the risk of the thromboembolic event. And of course, that varies on the context, whether you're in bleeding or in periprocedural. But there's also another component which is important, and that's the actual value that you as a clinician, your patient, will put on how it is to have a stroke or to have a bleeding and being admitted for a bleeding episode. And we all almost automatically, inherently attribute a certain amount of weighting to that and keep that in mind sometimes when you make your decisions. The general philosophy I want to bring you today is that as digestive endoscopists, we do not need to be experts on antithrombotic management, and I don't consider myself a hematologist or a cardiologist. But we do have a responsibility to, number one, understand the general principles, provide somewhat of a sanity check, since we're the ones doing the procedure when the patient is often prepared in front of you at the time. And finally, it's your responsibility to tailor the post-procedural recommendation, which basically will depend on how nasty you've been to the person's gut. So these are the two guidelines that I show you. It's actually one guideline, the top one, and Nina was the primary author on that. But we also published a little while later, both in the Red Journal, a dissemination tool. And the reason we did this is to make your lives and our lives easier in algorithm form, as well because there's so many areas that could not be informed because of lack of evidence. We then were able to kind of provide some common sense additional recommendations that went beyond the formatting for the usual guidelines themselves. I'll show you a little bit of both. So first, who are the patients who are at highest risk of thrombosis? So what I respectfully suggest to you is the rule of three. So this is amongst the patients who are on anticoagulants. They can be on anticoagulants because of mechanical heart valve, atrial fibrillation, or venous thromboembolism. Very simple. Anybody who's had an acute thrombotic event within the last three months, let it be a stroke, a TIA, or a thromboembolic event, this patient should not have an elective procedure. The risk of stopping the anticoagulant is so high that it does not justify doing an elective procedure. So it's what I call the rules of three. And interestingly, the chest guidelines, which are the big experts in hematology and cardiology, changed their guidelines from six months to three months. So it's now three months across the board, as we had suggested. And with regards to antiplatelets, it's a little bit different, a little bit more complex. But here, too, you have a risk of three, the rule of three. Anybody who's had an acute coronary syndrome over the past three months, you cannot do for many reasons, but not the least of which is being you cannot alter the dual antiplatelet therapy for these patients. And then it depends on whether they've had an ACS or not. If the patients have had a bare metal stent put in with an ACS, it's a one-month rule. Two-month rule if they've had an ACS event, one-month rule if they have not. And if they have a drug-eluting stent in place, you can see it's two months and six months. So this gives you a rough idea. Unfortunately, the guidelines do change. They do evolve. So this is just a rule of thumb for you to give you an idea, again, as a sanity check, which is all I'm trying to do in this context. This is all mapped out in the guidelines for you. So the other big component is understanding the pharmacology, and the pharmacology is actually pretty straightforward, and we know it already. This is from the old ASG guidelines, and you can see we know that warfarin takes five days for warfarin to disappear. This is why we bridge with low molecular weight heparin. So let me tell you right now, if you did not know, most patients do not need bridging anymore, period. All right? This is an important message, which is an older message, but I've lectured all over, including in Europe and here, and many people do not know this. I'll go over the data for you. The risk of bleeding is higher. The risk of thrombosis is not higher if you just stop the coumadin for five days. So there's no need to bridge the great majority of patients. I'll come back to that. DOACs used to be bridged, but it makes no sense, because as soon as you give a DOAC pill, within 12 hours, the patient is systemically anticoagulated. And when you stop the DOAC, within one day following the last dose, the risk of anticoagulation is much, much lower, so that it has such a quick turnover from a pharmacodynamic point of view that it is not necessary to bridge, and so DOACs are not bridged anymore. So with this in mind, I just also will look at the pharmacology of the antiplatelet agents. We know aspirin is about seven to 10 days, that it's effect on the platelets, and if you're looking at the thinopyridines, let it be a clopidogrel, ticagrel, or prazegrel, it's between three and seven days, roughly, let's say, five days. But finally, that's only part of the issue. The issue also depends on what can we do to decrease the bleeding risk, and there have been many changes. This is not an exhaustive list, but some examples, data suggests you can continue anticoagulation for small polyps, certainly for cold-snare polyps. I think most people know now that you probably should be removing most of the polyps by cold-snare non-pendunculated, certainly up to two centimeters, and in fact, there is decreased bleeding for the patients who are on antithrombotics if you do this, because you're not damaging the subucosal vessels and causing delayed bleeding. There's data to suggest you can continue clopidogrel, and in fact, in this study by Chen, patients that were on dual antiplatelet therapy, up to 30 percent of them with no re-bleeding, and they removed polyps over 10 millimeters. Prophylactic clipping, I remind you as well, when we do big polyps on the right side, at least two centimeters in size, there's a recommendation to do prophylactic clipping to decrease the bleeding risk. So there are a number of things that we can do. I'm not talking about this today, but in the endoscopy room to further decrease the bleeding risk. Okay, so let's have a look at antithrombotics. The way we define the risk of the procedures is an old classification. It's there, although it varies from society to society, but I think we would agree about the risk for high-bleeding procedures. You're looking at PEG, PEGI, RCP, sphincterotomy, third space work, and so on. You can see as you go down the list, the problem is that polypectomy of a polyp more than one centimeter is also in that, and that we cannot predict who's going to have a polyp of more than a centimeter. So because of this, the colonoscopy is considered potentially a high-risk procedure. That's the main problem when we deal with patients and antithrombotics. Okay, so with this in mind, let's have a look and see. This is the BRIDGE trial. These are the data from the randomized studies that showed that if you look at it, almost 1,800 patients randomized. When you look at bridging versus no bridging, it was non-inferior to perioperative bridging with low molecular weight heparin. With regards to thromboembolism, no increased thromboembolism rate. However, there was an increased rate of major bleeding. And the exclusion criteria, you don't have to go over them, but I put them there for you for reference purposes, exclude very few people except for the very high-risk patients. So there is no more bridging. One of the issues is the patients with valves. There's actually a PERIOP2 study was done that has issues with it, but also suggests that bridging is no need. So this is perhaps the most important slide of this component of the talk, and that's Although it's impossible to confidently estimate GI procedural bleeding risk associated with uninterrupted vitamin K antagonist therapy, we recommend that bridging should be, for most patients, is now out. And if you want to get an idea as to who should be bridged, you're looking at those with mechanical valves, atrial fibrillation, which scores a greater chance to greater than five. Patients having experienced thromboembolism during temporary interruption, and forget the cardiovascular surgeries. That's not for us. The data on the DOACs comes from a POS-GI study. This is a subgroup study from the POS study, and what you can see here is that when patients were stopped for one to two days before, almost 90 percent of the patients, and were restarted within two days, this is the approach that the POS study did. Granted, most patients had low-risk procedures, but nonetheless stopped for one to two days and restarted within two days. What does this yield? It yields a thromboembolic rate of 0.7 percent and a major GI bleeding rate of 0.9 percent, which was deemed acceptable by cardiologists as well as hematologists and gastroenterologists. It's not a randomized trial. It's an observational study, but it gives you an idea of what this approach does. Last component I want to mention to you is the timing. This is important. This is from the POS study. So what you have here are the patients who experienced GI bleeding, the time of bleeding in days. This is the day of the procedure, and that's the duration of the interruption of the thromboembolic agent, in this case, DOACs. And what you can see here is a bleeding event, which as a start was a major bleeding event requiring admission to hospital and perhaps intervention. And what you can see is there are two timelines for bleeding, the first within a day. Usually we pick that up right away as to what we're doing at the time, but then 10 days later roughly. And this is a problem because everybody's back on antithrombotics by then. So keep that in mind when you cancel your patient peri-procedure. So based on this, what are the recommendations, management of patients on the vitamin K antagonist in the endoscopic elective peri-procedural setting? Patients at low risk who are having a low-risk procedure, you carry on with the vitamin K antagonist. Patients with a high-risk procedure, if the vitamin K antagonist was stopped, consider holding it for five days before the procedure. As I told you, most patients do not need bridging. And we suggest, in fact, against it and consider resuming it after immediate endoscopic hemostasis. Don't forget, you can start the Coumadin within a day or two because it's going to take five days to kick in. With regards to, sorry, with regards to, I apologize, with regards to patients on DOACs, pretty straightforward, we suggest temporary DOAC interruption one to two days before the procedure. And you consider resumption of the DOAC the day after the procedure in most patients or a couple days later if you've had a high-risk procedure and they're high-risk for bleeding. So pretty straightforward for the antithrombotics. The antiplatelets, what you can see here, single antiplatelet use, we do not recommend for primary cardiovascular prevention. Really, the risks are much greater. You should just stop the aspirin in that case for patients. Patients on aspirin, we suggest against its interruption and you can carry on right through and resumption if you have it stopped soon thereafter. If the patients are on single antiplatelet therapy with a P2Y12 inhibiting agent, then we really don't know. There's not a good data, but we recommend a five to seven-day interruption, periprocedural interruption. There are very few data on that, unfortunately, that I can help you with. That's where we extrapolated from the literature more than the following information. And if we look at dual antiplatelet therapy, you carry on the aspirin right through and you stop the P2Y12 for, again, interruption of five to seven days periprocedurally. So those are the recommendations for the antithrombotics in the elective periprocedural period. If we look at GI bleeding, first on anticoagulants, patients who are on an anticoagulant, if they have a life-threatening bleed, consider giving PCC, prothrombin concentrate. However, the life-threatening bleed is extremely rare. These are patients who have massive bleeding, they go with massive bleeding protocol. We don't get called about these people. These people are weeded out before we ever actually get to see them. So the great majority of patients don't fit in there, but those would be considered for direct reversal agents or PCC as well if they're on a DOAC. Ninety to 95% of patients you'll see have non-life-threatening bleeding. These patients, if they're on a vitamin K antagonist, we suggest against fresh frozen or vitamin K because it takes so long to act or it needs so much volume for the patient. We could not recommend for or against PCC, but I'm telling you that we do not recommend it as a rule. And for patients on DOAC, we suggest it against drug-specific reversal agents or PCC. So someone may ask me, yeah, but what about the INR, what do we do? There is no threshold INR for scoping a patient in the acute context of a bleed anymore unless the patient's actually bleeding spontaneously with bruising, bleeding from the gums, nose bleeds and so on for two reasons, because the data does not support it and because when patients are on a DOAC, as you know, the INR is not that helpful. As to resumption, resumption is not clear-cut, but we recommend with regards to restarting a DOAC and Warfarin sooner within the next seven days, ideally within the next three days, which is what it takes to go from a high to a low-risk lesion amongst patients with peptic ulcer bleeding, but again, very little data on that. What about patients who have acute bleeding on an antiplatelet agent? So the resumption, because I told you we don't stop the aspirin, the resumption should be if you have stopped it within three to five days, but we do not recommend stopping aspirin and there's actually a randomized trial that clearly showed that the risks are greater at stopping it than not when a patient presents with an acute peptic ulcer bleed. With regards to the more general approach to patients on antiplatelet agents presenting with GI bleeding, I actually did not know this and learned it during the guidelines. We suggest against platelet transfusions unless you're giving it for thrombocytopenia. Platelet transfusions in patients because they're on antiplatelet agents actually causes thrombosis. It causes major problems and you should not be considering it. If, however, the patient is on aspirin for secondary cardiovascular prevention, as I mentioned, we suggest continuing the aspirin. If it was stopped, we suggest restarting it as soon as possible. So you can do anything on aspirin or almost anything on aspirin, basically, including managing patients with GI bleeding. With regards to patients on dual antiplatelet therapy, again, very little data. We weren't able to extract much from the literature, but if there's low-risk stigmata, you carry on with the dual antiplatelet therapy without stopping it. Patients who have high-risk stigmata, we suggest the same. We approach the same kind of vague recommendations, unfortunately. That's all we can do is you stop it from anywhere for five to seven days and restart it thereafter. The Asian-Pacific guidelines suggest something similar to this, again, based on very little information. The last issue is that secondary prophylaxis, just a reminder for you. This is an older issue, but in patients who have had previous ulcerative bleeding receiving cardiovascular prophylaxis with single or dual antiplatelet therapy, that patient should remain on the PPI for as long as they need that cardiovascular prophylaxis, which for many patients is long-term. This is based on very limited data and, of course, assumes that you're going to test and treat appropriately for HP and eradicate if it's present. Finally, for patients who have previous ulcerative bleeding and who require continued cardiovascular prophylaxis with anticoagulant therapy, same thing. We suggest continuing the PPI versus no PPI for as long as that patient requires the use, in this case, of anticoagulants based on a limited number of data, although we have some indirect data from a randomized trial. Those are the recommendations right now, but these, as I mentioned, are a little bit of an older message to you than the ones I've presented to you before. In the context of elective GI procedures in patients' antithrombotics, number one, you delay the procedures in patients at high risk of thrombosis. Remember the three-month rule. Only stop antithrombotics if high-risk endoscopic procedures, unfortunately the colonoscopy may fit in for most cases, so you have to budget that in your mind when you're creating your guidelines for your endoscopy unit. I remind you that no bridging needs to be done for the great majority of patients, so you stop the warfarin five days before and you restart it anywhere the day after, understanding it's going to take five days to kick in, and the DOAC is basically you switch on and you switch off, so you can stop it one to two days before and restart it anywhere from one to three days following the procedure, depending on what the high risk of bleeding is or not following the endoscopic procedure. For aspirin, you do not stop aspirin, period. You carry on throughout, whether you elect, I'll talk about bleeding in a second, but aspirin in the elective case, and if you have a patient who is on dual anti-bleeding therapy or even on sole P2Y12, you may want to go ahead and perhaps bridge with aspirin. It's not clear. I would suggest just interrupt it for five to seven days and restart it. Resumption again is based on what you decide. Whatever you do, if it's very low risk or if you find the patient was fine or if you did very nothing, obviously they can restart right away. The more you've been aggressive, the more you have to decide to consider perhaps delaying by a day or two, but remember that most of the bleeds will occur 10 to 12 days to 15 days later. Patients are back on antithrombotics, and you also have to counsel them for that. Restart the Doac or Warfarin within two to three days and the P2Y12, I said before, within the five to seven days. For the patients who present with acute bleeding, in conclusion, who are on anti-coagulant, only correct the coagulopathy if it's life-threatening. I didn't give you the data for lack of time, but life-threatening bleed is someone who's bled at least five grams per liter hemoglobin or who has received five units of blood. So really, it represents a very small proportion of the patients we see. Doacversol agents also, only if it's a life-threatening bleed, and restart within three to seven days. Sooner if it's a vitamin K antagonist because it's going to take five days to kick in. Acute GI bleeding in patients on antiplates, forget platelet transfusion, there's no role, it causes trouble. Stop aspirin if it's taken for prime prevention, as I told you before, but if not, you just keep on with the aspirin, absolutely no problem. And if the antithrombotic has been stopped, you resume soon after hemostasis, and again, with the P2Y12, you may just interrupt for a total of five to seven days. And finally, don't forget the issue of secondary prophylaxis. In my mind, it also includes HP testing and treating for patients who are on antithrombotics who would need to remain on prophylaxis for as long as they have the indication because of the past history of bleeding. That's it, and I thank you very much for your attention. Thank you. Thank you all, and we're going to move now to our second debate, GLP1 agonist, hold them or allow to do about nothing. Dr. Rezae from Cedars-Sinai is going to be talking in favor of holding them, and Dr. Joshua Atkins from the University of Pennsylvania will talk in favor of continuing. As Dr. Rezae comes to the podium, currently for your endoscopic procedures, we would like to see a raise of hands. Who holds the GLP1s? Okay, let's see where we are at the end of this talk. You're first. I'm first. Oh, that's Josh. Here. I'm sorry. Josh, you're second. You're first. I think we should go down. It's Allie. All right. It's Rezae. All right. Good afternoon, everyone. Josh Atkins. I'm an anesthesiologist at the University of Pennsylvania and director of the anesthesia for our endoscopy center. It's a great pleasure to be here. I find I do a lot of multidisciplinary work. I'm really an airway specialist with the University of Pennsylvania. I do a lot of multidisciplinary work. of the anesthesia for our endoscopy center. It's a great pleasure to be here. I find I do a lot of multidisciplinary work. I'm really an airway specialist with hospital airway safety, but today I'm privileged to speak today on our roles in GLP-1s. Multidisciplinary conversations are the best, and I'm really excited to have the opportunity to thank the organizers. I look forward to Dr. Rezai and what you have to say. And I want to find that your colleague, Dr. Williams, afterward to talk about cheating in the NPO exam. So let's say we have a full few disclosures. Nothing's related to anything I'm going to speak today. So we have 48-year-old Candice, who's the generally healthy mother of three with familial history of colon cancer and a positive FIT test. She's married to an officer in the armed forces who has a lengthy overseas deployment, and she's on weekly GLPs for weight loss. She presents for colonoscopy, having taken her medicine the day before, and is otherwise asymptomatic, but consistent with ASA guidance and European institutional policy, she's postponed. She doesn't return for 18 months due to scheduling challenges, and on subsequent colonoscopy is found to have an invasive lesion. I think this is what we're all trying to prevent from complex medication postponement regimens. So I'm going to weigh in a little bit on this. A few opening statements. One is that GLP-1 medications do, in fact, delay gastric emptying. I'm going to acknowledge that point, but also say that I think we all agree that delayed gastric emptying doesn't equate to aspiration. And studies demonstrate that delayed gastric emptying, or full stomach in patients with long-standing diabetes, 5% in type 1 and 1% in poorly controlled type 2. And yet, we seem to handle most of our patients. I can't remember the time we had a patient with diabetes that we handled through anything but our routine protocol. And we do have case reports demonstrating aspiration in patients on GLP-1s, but we really need to pose the question, is this really increased risk or a biased observation? So Subway did a good thing, and they went through and they basically looked at all of the guidance. We probably have an international audience here. They looked at all the guidance on this. And basically, some is very recent. The ANZ from Australia is 2024. The ASA in June 2023. Others go back to 2015. And as most of you know, these medications were first approved in 2005 when biota was Exanatide was approved by the U.S. FDA for second-line treatment of diabetes. Of course, the number of patient GLP-1s has rapidly expanded. And there's extensive variation in these guidelines and nuanced statements. Statements are, excuse me, statements. Guidelines are not statements. And these are essentially not the same level. They're consistent themes that include a universally-based low evidence and low volume of evidence. Expert opinion emphasized that you should always use your clinical judgment despite what these statements say. They recommend asking patients if they're on GLP-1, asking about symptoms of abdominal distress. And they tend to reference giving consideration, regardless of what you do, to the potential increased risk of residual gastric contents on patients on GLP-1s, even when not explicitly recommending to hold. Interestingly, some societies, like the Australians, have managed to get everyone in the same place. Diabeticians, gastroenterologists, and anesthesiologists, whereas the ASA and the AGA can't seem to agree on anything. So the ANZ, for example, references four weeks as the appropriate duration due to half-lives. The ASA has picked seven days, and others say the day before surgery. And the ANZA has different comments about people on medication for weight loss versus diabetes, and have more restrictive for those for general anesthesia than for endoscopy. The UK Center for Perioperative Care references that all these drugs and diabetes are known to delay gastric emptying, but no changes to anesthetic management are routinely indicated for diabetes. And so therefore, this doesn't rise to the level of appropriate evidence. So they're all over the place. If you have a patient who cubs, it is on these medications, what do you do? Sorry, this advance figure is not working. What do you do? If there's an AV person, this thing is not. What do you do? The guide is, again, all over the place. But they universally reference gastric ultrasound as sort of one escape hatch, if you want to say that. And then one document actually suggests, I think it did now advance. One suggests that you consider three milligrams per kilogram of erythromycin on the day of the procedure. And that's something that I really have never heard of in our discussions at Penn. So I'd be interested to see if you all do that. Next slide, please. So many questions. How does the choice of medication and dosing regimen impact gastric emptying? Is there tachyphylaxis? What's the optimal time? How do the effects of diabetes and GLP-1s compare? And is aspiration to risk really increased specifically in the setting of EGD? Next slide, please. So I remember as a child, I don't know if any of you read the Choose Your Own Adventure series, which I realized wasn't stopped until about 1998. And you have the great content conundrum. I mean, we could go in any which direction with these guidelines. So what do we do? Well, the first question I want to say is, what's the date on tachyphylaxis? So this is an interesting study by Camilleri. And basically, they had a patient series where they looked at titrating one of these GLP-1s and then over four weeks, and then continue it for 16 weeks and using scintigraphy with technetium-99 to look at an egg-based meal. And interestingly, in their 67 patients, they found 28 patients, and this is on the right, sorry, on your left, 28 patients had no effect at all on gastric emptying, 20 showed significant persistent delayed gastric emptying, and 19 showed tachyphylaxis. By week 16, they were returning toward baseline. The black line is the upper bound of 319 controls. In contrast, a Harvard group of Wu and others found that when they did a subgroup analysis of patients with retained gastric contents for EGD, they could not find any threshold of days, which was a marker for how long there would be residual gastric contents. Nassar et al. looked at food retention and endoscopy. And these are in patients over a wide timeframe. This is during most of this. Essentially, these patients had to be on a GLP-1 within seven days of their procedure. So they're violating guidelines. And they found, essentially, the only risk factor was EGD alone. That dual procedure with EGD plus colonoscopy effectively had no retained contents. And they also, though, interestingly found that there was stool retention in the GLP-1s, which could be of interest to the prior talk in the success of your procedures. Now, my colleague, another group, Dr. Silveira et al., out of Brazil, did a retrospective study. And this was also in the window before these guidelines came out. And this was 2020 to 2021. 400 patients, 33 of which were on semiglutide, which is that really long-acting one, which has a half-life of 10 days, of a week. And they stopped this for about 10 days. So nowhere near three half-lives. It's not the best statistical analysis. I did think they did fudge some things. Probably had a lot of analysis. They only had 33 patients in the semiglutide group. And they did a lot of multivariate analysis. So I don't know that 33 patients is enough. But fundamentally, they found that semiglutide use digestive symptoms were consistent with a high risk of residual gastric contents. And consistent with what I've just shown you, that colonoscopy combined with upper GI endoscopy seemed to be a protective factor. Essentially, no residual gastric contents. Then we have a great study, which is a study of 4,134 upper GI done at Mayo Clinic. And this is way before the guidelines. This goes way back to Bayetta. It essentially looked at aspiration and found that the aspiration, by manual chart review and automated searching analysis, the aspiration incidence was almost identical between the GLP patients on GLP-1 and not on GLP-1. This is a very large study over a lot of time when we really weren't focused in on these issues. And then my colleagues at Penn, along with Dr. Ginsberg, who I want to thank for proposing me for today's panel, we did a study, a chart review. This was over a course of time where basically most of the patients were taking their GLP-1 because it was before our guidance was changed. We looked at about 600 patients. And essentially, we found that the risk of retained gastric contents was high in GLP-1 patients, that this was especially true in patients going upper GI only. And that we really didn't find this almost none in statistically no difference for colonoscopy EGD combined procedures in terms of retained gastric contents. And that the odds ratio for retained gastric contents was lower in our group if the GLP therapy had extended greater than three months. So what can we do? The data is very clear that gastric ultrasound is a tool. It's very easy to do at the bedside. And it's reliable. So in 83 patients presenting for upper GI, all had a successful POCUS exam for GI assessing gastric contents. And in a study where they fed patients in a study negative, you know, NPO, feed you, redo the exam, it had a 100% negative predictive value. In other words, it was empty. It was really empty. They essentially did the EGD after that. And a 98.7% positive predictive value. So you have a little chance of a false positive, which is anyway going to err you on the side of safety. So I think patients for colonoscopy can continue their GLP1 medication. Patients for EGD can continue provided they adhere to a strict liquid diet for 24 to 48 hours prior. The gastric ultrasound is a useful tool to manage decision making in gray areas. And the patients are a high risk if they have an aspiration event due to medical frailty should be handled with the most conservative approach. I don't represent the American Society of Anesthesiologists. I don't represent Penn Medicine. And these are my own opinions. So I might actually move to New Zealand. It's a gorgeous place. And this is actually their statement that patients should be asked about the use. That there's insufficient data to support omission prior to endoscopy. That all patients taking these drugs within four weeks preceding an upper GI procedure should follow a fluid diet for 24 hours. That within four weeks undergoing colonoscopy should routine practice. And that basically if you think that there's a situation where you might be worried about concerns, you do a little old-fashioned 1960s lidocaine at the mouth, throw the scope in and say it doesn't look good, we should stop. Or it looks good and we should proceed. Because basically you're not inhibiting the protective reflexes. So we should trade war providers all across the board in doing these simple gastric exams. We should aggressively study this subject. We should rapidly adopt our guidance as these new findings come up. There are so many studies. If you go to clinicaltrials.gov and look at the studies that are looking at this liquid diets and so forth, we're going to have more data soon. And there's probably no one-size-fits-all solution. Thank you. Now let's hope for the opposite. Dr. Rezai from Cedars-Sinai is going to tell us about why we need to hold all of this GLP-1. Thank you so much. Thank you so much. Thanks for having me. As you can see, I'm a GM motility specialist. So I'm going to talk a little bit on the motility side. So I'm going to argue to hold the GLP-1s and just hold it and just move on type of approach. I don't have any relevant financial disclosures to this one. So let's go back to a little bit of physiology. And I promise it's going to be only 20 seconds. Remember, GLP-1 are produced by L-cells of our intestines in ileum and colon. Why do they get produced? So essentially, food makes it after passing through the proximal small bowel, gets to the ileum. It gets distended. And then ileum says, OK, I'm full, sends a feedback to the stomach. It was like, slow down because I need to digest this. This is what we call ileal break. That's why, for example, in GM motility, when we have somebody with ileal resection and profuse diarrhea and we can't stop it, we use GLP-1 agonist as an off-label therapy to stop the diarrhea. So slowing down the stomach is not just a side effect of GLP-1 or GLP-1 agonist. This is what they're made to do. They slow down the stomach. So after GLP-1 is produced, then DPP-4 goes and breaks it down, right? So that's why we have DPP-4 sort of antagonists, for example, as another treatment for diabetes, right? But when you develop GLP-1 agonist, receptor agonist, essentially, what we do is that we make them resistant to DPP-4, right? So they have a very substantially prolonged half-life. But look what has been done in the last two decades, right? Bayetta, as Dr. Atkins mentioned down at the bottom, was approved in 2005. So look at the half-life, 2.4 hours. And now look at the half-life of Ozempic, 168 hours. The data that you look at and regarding Bayetta and retention of stomach and gastric content after Bayetta is completely irrelevant to what we use these days. The GLP-1s that existed two decades ago have got nothing to do with the GLP-1s that we have right now. So I usually don't put generic, don't put brand names on my presentations. But in this situation, we have to put it because, you know, patients come in and you need to know the names of these drugs by heart. Because you like it or not, we need to know these one by one. So you can look, right, Ozempic, seven days is the half-life. Rebelsis is also the first oral one that is approved. And this is the new generation and is going to be the next wave that is going to hit us. And their half-life is going to get longer and longer and longer. And obviously, Monjaro is the newest kid on the block. And that is a GIP-1 and GLP-1. And that has a very long half-life as well. So this is a study that our fellow did just a few months ago. And look at the shifting trends in new GLP-1 users in the US. So essentially, the new prescriptions has gone up dramatically, especially in 2020. So in this database that was more than 110 million people, now 3% of them are on GLP-1 agonists. But that's not the only shift. Semaglutide in 2019 was 31% of the prescription. Now in 2023, it's 88%. So we have moved away from the short-acting GLP-1 agonists. So the data on short-acting GLP-1 agonists is irrelevant to the current clinical practice. And there is another shift that is happening as well, right? So even though all the groups of GLP-1 use are increasing, whether obesity or diabetes or off-label use, what is rising rapidly are those red bars, which are the obesity. So people are using it for obesity mostly, which is not surprising. And also off-label use, essentially somebody that is within BMI of normal BMI and no diabetes, has doubled in the last three years. And that's another important thing, because people are just taking it without even telling you because now you can even get it off the street these days, right? And that is going to get worse now that the oral medications are coming in. So now let's talk about this. Does that physiologic effect of GLP-1 agonists do really decrease the gastric emptying? And the answer is yes. Yes. It does affect the gastric emptying now, no matter what studies you look at. One important thing that I wanted to mention is that the acetaminophen or Tylenol essentially absorption tests that are used in clinical trials have no validity in clinical practice. So there was no difference seen there. But you see it in clinical trials. But we don't put a lot of weight on how accurate it is in terms of the value in regards to gastric emptying. And also, two out of three retrospective studies showed that the higher retained food, including an Arab study that Dr. Atkins referred to by Nasser Atal, that we saw some food retention. But for us, what matters? Do fasting prior to the procedure decrease and fix the problem of gastric retention? And this was answered very well by the study that was published in JAMA Surgery. So essentially, they had 125 fasting participants. This is before guidelines. So nobody was stopping the GLP-1s. And they did a gastric ultrasound. And they checked whether the stomach is full or not. And what they saw was that GLP-1 agonists were associated with 30% increase in gastric content. So an after adjustment for all the confounding. And how long they were on these medications didn't really matter. So tachyflexus was not a factor. But now the main question becomes, this extra gastric content in the stomach, does it correlate to aspiration? Right? Because we do see patients with a full stomach. And then we do our sort of percussions. And most of the times, you don't see an aspiration. The reason why is that aspiration is still a very rare event. So unless you have a big population, you're not going to be powered to find it. So this is a study that we did about a few months ago. And we looked at 70 million subjects. And we could find about 800,000 patients on GLP-1s. And we had 20,000 patients that were on GLP-1s and had endoscopy. And we had lots of controls. And we could match for 57 confounders. So what we found was that the risk of aspiration pneumonia increase in these patients by 33%, right? But the absolute risk increase was very small. It increased from 0.6 to 0.8, so about 0.2%. So it's a small increase, but statistically significant increase in risk of aspiration. So now, another point is that this is not a problem with their data or anything, because when we looked at non-GLP-1 receptor agonist medications, such as HGLT-2 or DPP-4 inhibitors, they did not increase the risk of aspiration. So it is a class-dependent risk of aspiration related to GLP-1s. So now, the next question is that, well, 0.2%, that's nothing. Should I be worried about it? So I'll give you an example, right? When you wear your seat belt, that decreases the relative risk of death by accident by about 45%, right? But if you look at the absolute risk reduction, it increases your chance of death by 0.016%. So it's a very small phenomenon, right? The annual risk of death of an unrestrained passenger in the US is about 0.03%. So you can get away with it if you don't want to wear your seat belt, but nobody does that, right? And 10% of people in the US still don't wear seat belts. And if we make those people wear seat belts, even though the absolute risk reduction is only 0.01%, you will save about 5,000 lives. And if nobody wears seat belts starting tomorrow, we will have more than 55,000 deaths just because of motor vehicle accidents per year starting tomorrow. So small absolute risk reductions matter. And so let's put it into context of the number of endoscopies that we do. We do 20 million GI endoscopies in the US alone. And if you just conservatively consider 3% of our patients are on GLP-1s, which, by the way, by 2030, it's estimated to be 7%, there's going to be 1,200 cases of aspiration if we don't do any preventative measures. So I'm just going to wrap up with this slide. So why do I suggest that we should hold it at this point? It's because physiologically, that's what they do. Objectively, we know that they decrease gastric emptying. Post-procedure fasting, we know that it doesn't work that well for GLP-1s. And also, it's associated with small but significant risk of aspiration pneumonia. And also, our bottom line is that airway production falls within domain of anesthesiologists. Right now, ASA tells us to do it. We should do it. We don't tell them how to ban varices. We shouldn't tell them how to protect airways either. So with that, I'll hold off. Thank you very much, Ali. So before we move to our next speaker, let's repeat our poll. Who's going to do endoscopy and continue GLP-1s? OK. Dr. Atkins, thank you so much. That was very brave to come and jump into the shark pond. When we first envisioned this session going, we thought GI would be the, I want to continue. And Ali was like, no, I want to stop them. It's like, OK, now I need an anesthesiologist that will take the opposite approach. But definitely an area for more discussion. So I'm honored, truly honored, to introduce the last speaker of this session. Dr. Jonathan Leighton is a colleague and partner of mine at the Mayo Clinic in Arizona, where he's a full professor. He's going to give a state-of-the-art talk on quality indicators for capsule endoscopy and deep endoscopy. Dr. Leighton. Good afternoon, everyone. And it's really great to be here. I love the collaboration between the American College of Gastroenterology and the ASGE. And I want to congratulate Dr. Prateek Sharma on his presidency this year. And of course, thank Michelle, Irving, and Nalini for inviting me. So we're going to talk on quality indicators for capsule and deep endoscopy. And I will say that I did my first capsule in 2002. So it only took 20 years to come out with a joint paper with the ASGE. My only disclosure is that I didn't do it alone. And so my gratitude to my other authors, Drs. Brock, Semrad, Haas, Gouda, Barkin, and Eisen. And so the way we did it was we reported as the ratio between the incidence of correct performance and the opportunity for correct performance, and divided it into three categories, structural, process, and outcome. And the measure was considered valid if compliance would be critical to providing quality care exclusive of cost or feasibility, and then divided it into pre-procedure, inter-procedure, and post-procedure. So I will walk through these. And we'll start with capsule endoscopy pre-procedure. And we thought that it was important to demonstrate competency to perform for the proper indication, identify risk factors, document informed consent, and then perform in a timely manner. And interestingly, as we voted, bowel prep was not felt to be an appropriate quality indicator at the time because of conflicting data. But in terms of demonstrating competency, we all know that there are multiple formal training options, as you can see from direct observation to testing videos to written assessments. And in terms of minimum number of capsules, the European guidelines recommend 30 to 50, and then the ASGE in their 2017 guideline recommended 20. In a prospective study that we did at Mayo led by Rochester, we found significant differences were present in the yield between attendings and fellows if they had less than 20 studies. And then the learning curve flattens at about 25. So that gives you some idea of how many you would want to do to be competent. And then it's important to realize that you want to perform for an indication that's appropriate and realize that if you do those, such as the small bowel bleeding on the left, iron deficiency, Crohn's, inherited polyposis syndromes, abnormal small bowel imaging, or complicated and refractory celiac disease, you can see that those appropriate indications have a markedly increased diagnostic yield. And if you perform for a non-standard indication, and certainly you can do that, and justification should be documented, the yield is going to be lower for those on the right. It's also important to know the contraindications to capsule. The only absolute one is if you have a known stenosis or intestinal obstruction. Relative contraindications are implantable cardiac devices, although based on the literature, the risk appears to be low. Pregnancy, swallowing disorders, realizing that if the patient requires an MRI after the capsule, realizing that if the patient requires an MRI after the capsule, you want to document passage. And then children less than two years of age. And then, of course, it's always important to obtain written informed consent, discussing the risks of retention, the possibility of misleasions, battery expiration, and avoiding an MRI until the capsule's passed. We wanted to highlight that it doesn't appear surgically altered anatomy increases the risk of complications with capsule. And then identifying the risk factors for retention and luminal patency. And we defined the retention as a capsule being in the small bowel for greater than two weeks. The incidence is relatively low for small bowel bleeding, and not as high as we once thought for known Crohn's disease at 4.6%. But the potential risk factors for retention would include not only Crohn's, but also a history of small bowel obstruction, previous resections, radiation therapy, chronic NSAIDs, and, of course, a known stricture or the presence of symptoms. And so if you really, you know, if any of those are positive, then we do recommend either the patency capsule or cross-sectional imaging. And then the other important thing is to understand the diagnostic yield and the timing of capsule. And you can see there the diagnostic yields for a variety of diseases. But just like any endoscopic procedure, the yield is improved if it's closer to the bleeding episode. And in inpatients, 90% yield if within 48 hours of a bleeding onset. And for outpatients, although, again, limited data, it's recommended within 14 days of a bleeding episode. And there is that one study that showed the yield was 90% within 15 days versus 34% greater than 15 days. And then I mentioned that the bowel prep did not come up as a quality metric. But in this recent study from 2022, you can see that there was no significant difference in the diagnostic yield of highly relevant lesions, whether they use clear liquids or a formal bowel prep. So the use of a purgative bowel preparation before capsule doesn't improve the diagnostic yield or visualization. And this study led our center to stop using our two liter prep. Moving on to intra-procedure quality indicators. Again, performing in someone with a risk of gastric retention or contradications to swallowing. So you can see there swallowing difficulties, delayed emptying, altered mental status. You can consider it in inpatient or bed-bound patients or concern because of a prior incomplete study. And again, as I mentioned earlier, not necessary to do in gastro-duodenal surgery. And then the post-procedures, again, are important. And it reminded me that with Dr. Sharma's talk that maybe we will have AI take care of most of these issues that right now we have to do manually. But it's important to perform photo documentation and document transit times. It's really important to use a standardized reading method. We'll talk about that. Appropriate management based on findings, commenting on completeness of the exam, tracking complications, performing an X-ray two weeks or more after an incomplete exam, and generating a complete report. So in terms of the photo documentation, it's really important to document the first gastric image, the duodenal and the sacral image. And realize that when you've done that, if the transit time is less than two hours, again, there's not a lot of data, but it may lead to missed lesions. And then lesion localization for deep enteroscopy is if using the anti-grade approach, if it's lesions within the first 60% of the small bowel transit and the retrograde if it is over 60%. Also, it's good to use a standardized reading method. So if you're going to use the single frame mode, a maximum of 10 images per second. If you're going to use dual or multi-frame, a maximum of 20 images per second. Because higher than that, there's an increased risk of missing lesions. You may want to consider a slower rate in the proximal small bowel, because that's where the capsule moves the quickest. And then just remember that if you're going to do multiple studies, there is reading fatigue, and you want to pace yourself. And then really critical to recommend appropriate management plan based on the findings. You also want to document the adequacy of the visualization and completeness of the exam, because it can have an impact, just as we do in colonoscopy. Because it can occur in 20% to 30% of patients. You can see the risk factors there, particularly hospitalization, narcotic use. And it's important that the patients either visually confirm excretion, or you perform an abdominal X-ray sometime after two weeks, if no witnessed excretion. And I also like to recommend that you avoid gastric and small bowel biopsies before passing the capsule, because that can lead to false positive lesions. Also, obviously tracking any complications and documenting appropriate management. We talked about adverse event rates about 2%. And then it is not uncommon to have asymptomatic retention. And it's, in most patients, watching and waiting, because most will pass. If they are still there, you can consider laxative or prokinetics. And then disease-specific medical therapy, such as steroids and Crohn's disease. If there is symptomatic retention, then it's going to mean either early deep enteroscopy or surgery. And then finally, document appropriate management in your report. So the take-home points, I think, for capsule is, again, the importance of the clinical history, documenting endoscopic versus oral ingestion, making sure you do the transit times, document the bowel prep quality, image, landmarks, completeness of the study, comment on retention, and then diagnostic findings and plan of care. Moving on to deep enteroscopy, again, the same in the pre-procedure, demonstrating competency, performing for the right indication. In this case, reviewing the capsule or cross-sectional imaging before doing deep enteroscopy, discussing anticoagulation management, and then documenting the choice of insertion route. And again, competency, this is a procedure that does have a steep learning curve. There's no standardized training requirements in the US. The ESG recommends 75 procedures. And then in terms of learning curve flattening with single balloon, there's data that suggests it's about 30. For double balloon, 10 to 15 procedures. In terms of clinical impact, the first 50 procedures achieved a 58% diagnostic yield after 286%. So that's why we think of it as a steep learning curve. The indications are fairly broad, similar to capsule endoscopy. And remember, also, you can use it for placement of pegs, access for altered anatomy, and then valuation of malabsorptive states and refractory celiac disease. Now, this is important that we believe that reviewing a capsule or cross-sectional imaging prior to deep enteroscopy is really important to decide the approach of insertion. And then also devising a periprocedural anticoagulation management plan, as you just heard from Dr. Barkin, with the risk of bleeding goes up if you do, obviously, therapeutics. It's reasonable to continue aspirin. And in some difficult cases with recurrent bleeding, we actually recommend doing it on anticoagulation. And then remember, the total enteroscopy completion rates vary significantly. Now, I already mentioned that it's important to base the insertion rate on the small bowel transit times. And that's why it's important to look at as much data as you can get. And the transit times, Melanin predicts a proximal small bowel. And in massive avert bleeding, we prefer the antigrade approach due to the fact that there's going to be a higher diagnostic yield. And if you're not sure of the location, also start with an antigrade approach. It's important to remember that a negative capsule allows for the avoidance of deep enteroscopy in patients with a low pretest probability. And similar to capsule, deep enteroscopy should be performed as close to the bleeding episode as possible. For intra-procedure, again, performing deep enteroscopy in a timely manner, we recommend carbon dioxide. We recommend estimating the depth of advancement, marking the most distal point with a tattoo, treating significant lesions, and treating vascular lesions that are the potential source of bleeding. And again, the same thing with doing endoscopy any time. Doing it in a timely manner within 72 hours is ideal. The choice of the endoscope, we think that double balloon, single balloon have equivalent yields. And in urgent or persistent bleeding, doing it without doing a capsule first. And otherwise, consider interventional radiology or intraoperative endoscopy if deep enteroscopy is unavailable. CO2, we now use that entirely because it improves the depth of insertion and reduces patient discomfort versus air insufflation. And there are randomized controlled trials on this. I think it's useful to estimate the depth of advancement and document if the suspected lesion was reached and if total enteroscopy was performed. And then, incredibly important to mark the distal point of advancement if a lesion is not reached with a tattoo. Also important to obviously characterize and treat clinically significant lesions and photo document them, biopsy, and tattoo as needed. And also, you can do dilation of strictures, particularly if they are less than 5 centimeters, not ulcerated, and relatively straight. And then for vascular abnormalities, which is the things we see the most, then treat with endoscopic therapy, realizing that there are high rates of re-bleeding, and so you have to think of medical therapy in some of those patients once you've ruled out a serious lesion. For post-procedure, again, generating a complete report in the electronic health record and then tracking complications. And again, the management of coagulation was not deemed appropriate as a quality indicator because there is significant variation. And then generating a complete report in the electronic health record with a brief clinical history, the route of insertion, the estimated depth of insertion, abnormal findings with description and photo documentation, details of any therapeutic interventions. It's really important to state whether the primary goal was achieved and if the area of interest was reached. Complications at present, communicate with the referring physician with clear post-procedure instructions, and then additional standard quality indicators as for all GI procedures. Also, like capsule or any endoscopic procedure, tracking the complications such as perforation, bleeding, or pancreatitis, which is pretty uncommon, less than 1% with antivirate deep enteroscopy. The risk is increased with therapeutic interventions, obviously, and always consider admission based on comorbidities and clinical, or the presence of clinical instability. And then post-procedurally, obviously, document anticoagulation management and when to resume oral intake per standard guidelines. So, tips regarding quality balloon-assisted enteroscopy. Again, demonstrating competency. Really important to review the capsule study or the cross-sectional imaging before the procedure and documenting that in your note. Addressing the prior procedural anticoagulation. Base the insertion route on the capsule transit times or the lesion seen on CT or MR. Best to perform in a timely manner. We recommend CO2 insufflation. Marking the most distal point of advancement with a tattoo and treating clinically significant lesions, preferably, in this case, during advancement. And then being prepared to identify and manage complications. So, in conclusion, capsule endoscopy and deep enteroscopy have had an important impact on the diagnosis and management of small bowel diseases. Comprehensive quality indicators have been lacking in the U.S. And these quality indicators should improve the performance of these procedures in clinical practice. Incorporating these measures should also improve standardization of these procedures, which is certainly one of our goals. And in the manuscript, we also identified knowledge gaps and post-specific research questions to help guide future clinical studies to improve quality of capsule and deep enteroscopy. Thank you very much. We're going to ask all of our speakers to stay and come up here. Yeah, Jonathan, stay. We're gonna do our Q&A for, as well as the debate people. To come up for the point for some questions. And the TED Talks. So, I'm gonna stand, so we have enough chairs. Except for me. Do we have something? Except for my notes. Let's just get a piece of paper here. Yes. Okay. Okay. I'd like to be over there. You're good? That's fine. You got everybody? Got everybody. One more. Oh, I'm gonna sit behind. Make his way up here. You got running shoes on. We need one more? One more chair. Sorry, I'm used to standing. You know, I can't stand. No, no, no, you're fine. We'll just pull this over here. Is it okay if we move this to the podium? Oh, you don't think it'll reach. Okay. First question for Megan. What's the mechanism by which APC works in solitary rectal ulcers? Can I say that again? Yeah, louder. The mechanism by which APC works in solitary rectal ulcer syndrome. Yeah, so again, it's not gonna be your primary treatment of solitary rectal ulcer syndrome, right? These are more thought for those resistant solitary rectal ulcers. What the thought process is for that is when you're treating it with the APC, you're causing, again, like regeneration of those cells within the ulceration and trying to induce like re-epithelialization. So it's one of those like next efforts to try to prevent surgery for these patients. So again, this isn't like your primary treatment for those ulcerations, but for some of those resistant ulcers, it's worth an attempt to try to help that heal. Thank you. Renee, lots of questions about preps, but after an adequate prep and the patient comes in and it didn't work, what is your algorithm? What do you recommend after a failed prep? So essentially what we do, initially speaking, we do a two-day prep. We bring them in with a two-day prep with two layers of clear liquids and see if that works. But there's some patients, especially post-surgical patients, who we just can't do it. We had a patient once we prepped for five days and it just didn't work. I mean, that case, that assistive device I spoke about actually works really well. One of the cases they talked about was a patient who came in with a multi-day prep and was inadequately prepped, so they actually used it to lavage it. We don't have that where I am, but in most cases, a two-day prep works. So we do polyacetylene glycol for day two and day one before the prep and two days of a clear liquid diet. Great, thanks. Andy, do you have any tips for implementing technology or change when most people are resistant, like bringing a new endoscopic report on the current reporting system where the current one is working? You mean speaking in terms of? It's for Andy. It's about implementing change. Don't worry. Sorry. Yeah, so Irving, I think the steps remain the same regarding change management. And for good reason, I think that physicians and our colleagues are often the most resistant to change, but the steps remain the same. You gotta help people to understand the why. You gotta get a group together that is going to be the early adopters. And then you need to really implement the change and celebrate the wins. But it starts with the first thing, which is the why. Without the why, there really is no change. If you don't have a burning platform, I think you're really up for an uphill swim, if you will. So if you haven't read Simon Sinek's Start With Why, it's an amazing book. Yeah, I mean, there's a ton of resources out there on that, but you're 100% right. There's a question here for Alan. If you have a patient that's on aspirin, 325 milligrams, you're going to do a colon, and it's a therapeutic colon. You know you're going to do a polypectomy. Do you do anything differently? So the data aren't great, but up to 325, we would recommend continuing it right through. Although we should point out that the indications for 325 milligrams of aspirin daily are almost nonexistent. Most people that are taking 325 are taking it incorrectly. And that many people who take aspirin shouldn't be taking aspirin, period. 100%. Jonathan, what about capsules in patients with Roux-en-Y, altered anatomy? Should we be worried that they're going to get stuck, or? No. You want more? Okay. I have another Jonathan question. So you said we're not doing preps anymore for double balloon, or excuse me, for capsule. But what if the highest thing on your list, the biggest suspicion is AVMs? Would you prep in that setting? No, and when we say no prep, we do recommend a clear liquid diet. Otherwise, no prep. And remember that AVMs, angioictasias, are more common than the proximal small bowel. The prep is usually good there anyway. It's the distal small bowel, and if you're going to see a poor prep where you're going to have problems, then that might be in somebody with Crohn's disease. So the bottom line is you don't need to prep even if you're worried about vascular lesions. We have here a question for Ali Rezi. So if the GLP-1 half-life is seven days a week, why should we, why we're only recommending to hold the drugs for a week? Shouldn't we be holding them much longer? No, that's absolutely right. And you saw the Australian and New Zealand guidelines. They're saying four weeks now. So that's one other thing about GLP-1s. These are not medications that you stop them, you get stent thrombosis. These are medications that are not critical necessarily. If you stop the medication for a few weeks in somebody with obesity, well, they may gain a little bit of a weight, but not much more problems. And if you stop it in somebody with diabetes, the sugar control shouldn't dramatically change. And if it dramatically changed, that patient needs to be on a second agent at least for diabetes, because these are not insulin. So you're absolutely right. In future, how I see it is that we're gonna increase the length of withholding GLP-1s. Or go the exact opposite way, continue them. So Dr. Atkins, I have a question for you. So your talk very nicely illustrated this sort of development of the process of canceling cases and the panic that came about when people started seeing food in stomachs on drugs like somaglutide, et cetera. How would you suggest we approach our anesthesia colleagues in our units about what we've learned today? Like, what do you think is the best way to have that conversation? Well, I think one is I always approach this from why are we doing the procedure? How complicated has it been for this patient's procedure to be scheduled and what are the downsides of a delay? And operationally, how effective are we in our guidance? I mean, we're struggling with basic, as you pointed out, PrEP compliance, and how likely are you that people can't calculate one day, let alone four weeks? So it's gonna get increasingly complicated if we go that direction. So I think understanding that what Dr. Rezai said is absolutely right, that there is gastric retention. Two, understanding that there is a complication risk of aspiration. Two, sort of straddling the gray area of what's the likelihood of serious outcome from the aspiration. It's hard to say, but there are plenty of people that have a mild aspiration event, don't get hospitalized, and recover. Now, there's a risk there, but there's a risk with everything we do. And I think really this sweet spot really is the patient who's had a PrEP for colonoscopy. If they are, in my view, asymptomatic, low frailty, and have had a bowel PrEP for colonoscopy with liquid diet, they're at the lowest risk end, and you can have that conversation. I do think that empowering your teams to do gastric ultrasound could be another opportunity. I realize that's in our typical bailiwick, but there's no reason that an advanced practice provider in a high-efficiency service who's already doing other things, you probably do a couple of these a day, maybe. My suspicion is we're gonna fall in the middle of what each of you proposed. It's gonna be something to the effect of, if you're having a double and the person took the PrEP, it's gonna be fine if they didn't hold the drug and hold it in people that have a history of retained gastric contents and are on the drug. I think the biggest thing is to understand that as an anesthesiologist, I try to get our group to understand that this isn't based on some really great science, and that this seven days just comes out of the blue. And then I also try to understand what the gastroenterologists are dealing with, with efficiency, patient satisfaction, their own risk of delayed care, and that we often emphasize that we think this is benign, but there's a risk, too, of missing diagnoses. The biggest barrier to coming for a colonoscopy is doing the PrEP and scheduling it. Right, yeah, for sure. You know, I was actually very impressed about your gastric ultrasound, but my question is, who's going to do it? Is that an ultrasound tech? Is that a gastroenterologist, an anesthesiologist? It's gonna be a nurse anesthetist or an APP, probably. And is there training for that? I mean. There's structured training. I mean, there are some courses out there, but my understanding is that this is sort of like, you know, 20 capsules, but it's not as, you know, 20 gastric ultrasounds are rapid to do. I mean, you could do it in one day if you did it on every patient. Great. René, there's a question, another question on PrEPs. Can the, if you do complete the split dose of the colon PrEP the day before, is that good enough for an early morning colonoscopy? Are they speaking, so generally speaking, the longer you wait to get to the procedure, the more unclean the person is. So are they thinking like split PrEP in the morning and then in the evening versus in the evening at like two or three o'clock in the morning? If you're doing everything the day before, I don't, I didn't see any studies specifically addressing that. And what my feeling is that it would probably be similar to a single dose PrEP, but there was nothing that specifically stated that you were doing a split dose the day before. René, I mean, the only specific data I know is randomized trials that looked at patients who took day before and compared to split dose and actually stratified and randomized to patients who were scoped by 10.30 in the morning. And there was a huge difference between the two groups. The split dose was better. And interestingly, because we get this a lot, no increased risk of losing your, losing stool on the way in and so on. So it was really a win-win. So we've actually stopped all day before, basically based on that. Thanks. And Jonathan, there's a question about depth of, how do you gauge that, where are you in depth when you're inserting your scope for DBE? Yeah, we tried to do it based on forward movement of the scope. And it's not particularly accurate, but it's still, I think, good to estimate how far you went, but it's pretty simple. Until there's artificial intelligence that will tell us how far we've gone, it's just a manual estimation of the centimeters advancement, forward advancement. Thank you. Do you see anything? So there's a question in here, this is also for you, Jonathan. If there's melanin noted during antegrade or retrograde DBE without visualization of bleeding source due to melanic content, would you recommend repeating it with a bowel prep? I think they might have meant capsule. You're not gonna do a retrograde DBE without a prep, right? Definitely retrograde has to have. Yeah, so I bet that person, I bet that's a typo. But you know, it's like any endoscopic procedure that you do, if the prep's not good or there's a lot of blood in the stomach and the patient continues to bleed, then you do need to re-scope and of course that second look endoscopy. So I think the same would apply if you still want to identify a lesion. There's so many comments about, not questions, but comments about the GLP-1 stuff. Like literally, there's 10 different comments in here. Is it okay to give a dose of Reglan before all capsule endoscopy to increase the chance of a complete exam? You know, we do use simethicone and we don't routinely use Reglan and the guidelines don't suggest that. You could consider it on an individual basis or place it, if you have a history of gastroparesis, place it endoscopically. Okay, one more question. It's for Jonathan again, sorry. That's all right. It says, the patency capsule does not snap into the delivery device for endoscopic placement. Would this technique be considered safe? I didn't know that. What's the question? Well, it's a statement first, that the patency capsule doesn't fit into the endoscopic delivery, so you can't take it down. Yeah. So is it therefore unsafe, since it doesn't, and you should never place it endoscopically? No, if you can, it's fine. I mean, the idea of the patency capsule is, you know, it does dissolve. So the idea is just to be able to determine whether the patency capsule is staying in the bowel, small bowel, long enough. I think that the concern would be that you're taking it down in a non-intubated patient, Joshua's looking at it down at the end of the table, and it falls out of the thing and gets into the airway. Oh, I got it, I got it. Well, I guess I would look to my therapeutic endoscopist, you know, for, if they would have concern, but I. Listen, the things I've had to pull out of the back of people's throats accidentally. I mean, if you felt that you really need to do it, and you felt like you could do it safely, I think it would be reasonable. Dr. Barkin, do you, what's your approach in Canada? We don't use the specialized system, we take what we're saying, a Rothman basket, go ahead and just let it go. Take it with you. Yeah, take it with us, manner of speaking, yes. Got it, okay. Well, I want to thank all of our speakers, and our debaters for this wonderful session. Thank you very much. We'll resume at 2.20.

endoscopic practices

quality and safety

The Dirty Colon

bowel preparation

Boston Bowel Prep Scale

patient risk factors

antithrombotics management

bleeding risk

GLP-1 agonists

gastric emptying

aspiration risks

quality indicators

capsule enteroscopy

guidelines evolution