Good afternoon, everyone. It's just a minute after the hour. We have quite a few folks that are joining us today for the webinar, so we're thrilled about that. I'm going to give us just a moment or so for all of the folks to join that need to join the webinar, and we'll get started shortly. All right, well, let's get underway. Welcome to our program today, exploring the re-imagining of TAVR in the cath lab with the use of nurse-led sedation. I'm Denise Bushman, I'm the Vice President of Care Transformations with MedAxiom, and I'm joined today by representatives from the Structural Heart Teams at the University of Maryland Medical Center and the University of Texas Health San Antonio. So we're delighted that they've been able to join us. We're also very grateful to the Edwards Life Sciences Team. They're global leaders in patient-focused innovations for structural heart care, and this is one more example of that. They helped to sponsor MedAxiom's newly published white paper on optimizing efficiencies and outcomes for TAVR with nurse-led sedation. As part of joining today's webinar, you'll receive a copy in the chat along with a copy of the slides. So our speakers today have no disclosures that are relevant to today's content, and you'll see the functions at the bottom of the screen for both chat and Q&A. In the chat box is where you'll find a copy of today's slide, and in the Q&A is where we'd like you to post any questions you have for myself or certainly especially for members, our panelists and presenters. So if you could just make sure you enter those, Ari will be monitoring the chat for us, excuse me, will monitor the questions and answers for us and make sure that we ask those to the appropriate person that you'd like to direct it to. Also to let you know that along with the presentation material and the white paper, everyone who's registered for this webinar today will get a copy of the recording in the next three to five business days. So keep an eye on your email for that. There will also be an evaluation that posts at the conclusion of the webinar. We're very interested in your comments and thoughts as to how we can make these sessions better. If you have colleagues that couldn't attend today's session but are interested, they'll be able to find a copy of the recording on our Medaxium website. So please feel free to pass the good word along and share the information that we've presented today. So if, I assume we don't have any other questions, I'm going to move us along. And the reason for today's webinar is really part of what you see here. Back in 2015, shortly after TAVR became commercially available, what we saw in terms of procedure location is such that about two thirds of all procedures were performed in the operating room. That has since changed so that today we see that down to just under half of procedures. And it really accounts to about a 43% increase in cath lab based procedures. So with the movement of those procedures to the cath lab, we find there are additional opportunities that can be engaged with. So why nurse-led sedation and why should this be something we're talking about today? What we find is that with TAVR available to patients now of all risk categories, we're seeing higher and higher procedural volumes. And as those volumes increase, cardiovascular programs are now looking for ways to maintain access, optimize the resources that they have and overall improve efficiencies. And nurse-led sedation comes, fits very nicely into this whole piece. In nurse-led sedation, as we've known, has demonstrated clinical safety and supports nurses working at the top of their license. Our speakers today will address more of that. And then just a quick little advertisement where we came about this is all through the development of a nurse-led sedation white paper, as I mentioned in the introduction. In order to write the nurse-led sedation white paper, we interviewed lead physicians, program coordinators and cath lab managers from our two programs represented here today, the University of Maryland Medical Center and the University of Texas Health San Antonio. Some key findings that we found when developing this white paper will be experienced with implementing nurse-led sedation, including those driving factors behind adopting it, the benefits they've experienced and the considerations for others who might wish to implement a program and be successful in doing so. So to keep us moving along and without further ado, I would like to introduce the team from the University of Maryland Medical Center. With us today, Dr. Shahal was not able to be with us. I understand he's in the cath lab, but we have Dr. Haytham Alaham. He is Assistant Professor of Medicine at the University of Maryland School of Medicine and the University of Maryland Medical Center. And we also have Susan Huffman. She is the TAVR Clinical Program Manager at the University of Maryland Medical Center. Both of these folks were intimately engaged when it came to developing their nurse-led sedation program. So we're delighted that you've been able to join us today and go ahead and take over. I'm gonna advance the slide. All right, can you guys hear us well? Yes, we can. Thank you. All right, thank you again for having us and thank you for the introduction. And again, this was a really good collaboration between us and the XM team and the team at UT. This project, Dr. Shahal is Director of the Cath Lab here. And again, I'm one of the structural attendings at the University of Maryland. And Susan is our boss. She's one of the nurse practitioners, Susan Huffman here. And we work closely with Dr. Gluckta and the anesthesia team at the University of Maryland to get this going. It all came up actually just after the COVID. I think this was nationwide. We felt that there's definitely a shortage of anesthesia coverage throughout the hospital, especially for our procedural subspecialties. And the Cath Lab was definitely affected and the AP Lab and our hospital at the University of Maryland, we're definitely struggling with anesthesia coverage. And as we all know, patients with severe aortic stenosis, they are, especially with symptoms and critical findings on echo. It's a very time-sensitive, kind of time-sensitive medical problem and we need to address it as soon as possible. So to find a way around it, we met our administrators from the cardiology team and our administrator from the anesthesia team and the hospital administration. We all met, found the best way, the best solution we can offer our patients. And we came over a study by our colleagues at Emory that looked at this a couple of years ago. They found that nurse desolation and patients with transcatheter aortic valve replacement was a pretty safe alternative to monitor anesthesia care, which was the current kind of way of doing things. So from there, we had a very thorough discussion about how we can start this. And it took a good year and a half, a good year, find a workflow and we're gonna go through the details about which patients and the criteria and the enclosing criteria, which are the ones who are safe to be done through nurse sedation, the training of our nursing team, the training of our cath lab staff, the workflow, getting the patients in and going forward. So it took a good year. And I remember I was an interventional fellow during that year. So I wasn't even starting and attending and I saw the whole process. I was lucky enough to saw the whole process. And during my structural year, I saw the transition. So I saw first we were doing most of the cases as monitored anesthesia care. And when the project kind of hit off and we started going into nurse sedation, I can see that I saw the transition and I was lucky enough to be trained. I would say for half of my cases, the structural cases are with nurse sedation. So as I graduated and now we try to do mainly nurse sedation cases in the catheterization lab. So over the course of the two, three years, there was definitely a lot of evolution of the process. And I think the goal is moving forward is to kind of do all of our cases, the majority of our cases as nurse sedation. So I feel like, as Dr. Hall was saying, we initially got our stakeholders together, which included our cardiac and seizure team, the cardiac surgeons who were actually have Dr. Doug Anderson here too, who is our primary cardiac surgeon involved in our TAVR program, with some concerns about whether or not the patients in case of an emergency, as we all have in the back of our minds, what would be our backup plan? So with the coordination with nurse leadership and the cath lab, we developed a protocol, which I think Denise is gonna share with everybody, but just to kind of make everybody comfortable and in the rare case that there's an emergency, what are the next steps? After that, we met with the cath lab staff, we kind of discussed the plan and any other hesitations. And then we actually had a nurse from another program come in and do the first couple of cases, with the nurses to kind of walk through and make them feel comfortable. I think that's pretty much. Yeah, I think that was the main thing. So this is just kind of one of the first pages of our criteria. So our inclusion criteria, we all sit down in our multidisciplinary clinic, we meet with the patients, we talk with them. Initially, we wanted to make sure that the patients were comfortable with getting nurse led or the fentanyl versa, rather than having a cardiac anesthesiologist involved. So we did BMI less than 40 ejection fraction. I think it's supposed to be 40%, but we have done some inpatients that have lower EFs. If they have OSA, then they would bring in their CPAP device, again, not claustrophobic, and then amenable to femoral access and no alternative access. And as you can see below, our exclusion criteria was BMI greater than 40, difficult airways. So again, in clinic, we're assessing all the patients, making sure their malampiti is adequate in their ASA score. Anybody with aspiration risk, again, EF less than 30%. Unable to lie flat, again, patient preference. So, you know, kind of, again, discussing with them initially whether or not they were comfortable with just the first side and fentanyl versus having a cardiac anesthesia available and then the malampiti and ASA score. I think this criteria is definitely a work in progress. And we mainly kind of looked over other places we're doing nurse-led sedation and kind of went over almost similar criteria. And it's not set in stone. So there are definitely cases where we do some exceptions and I think we'll talk about it later, but that's where nurse-led sedation comes into play. It gives us the flexibility of scheduling our patients. And there's an urgent or emergent case that we need to be done, and it doesn't really qualify with the criteria, but with limited anesthesia availability during that time, we're able to help that patient in a timely manner. But it's really important to look at this criteria and I think that was a very important step to start with, who are the patients who are safe to get nurse-led sedation and go through it. And like Dr. Alvin, just to add to that is, you know, we do a lot of highly complex CCIs here in so many cases, balloon pump, transplant patients. So, you know, our cath lab is dealing with, or used to dealing with those kinds of patients. So, you know, we felt comfortable with the nursing staff. Yep, I think that's one of the main key factors is making sure, and again, I think this is institute-dependent. I think the nursing staff, you know, it's a big change for them. Going from monitor anesthesia care, there's a lot of responsibility on the nursing staff, but again, also on the operators. You know, when we are doing the monitor anesthesia care, we have our anesthesia colleagues kind of monitoring the vitals and going off what they need to do to stabilize the patient while we go through the procedure. But obviously, when we are doing this under nurse-led sedation, you are the one that's scoring the shots. And we have certain protocols, which we're going to go into further in a few minutes, that basically you're dealing with the hemodynamic stability of the patient while maintaining a smooth operation throughout. So, yep. I don't know anything, Dr. Anderson. No, I think that as our experience with this has gone over time, I think we've gotten more and more comfortable with what we're able to do with nurse-led sedation. We have an outstanding catalog team that's able to accommodate these types of cases. And to Dr. Alvarez's point, I think a lot of it is kind of increasing the decision-making awareness of what's going on with the patient at all times. But, you know, to be honest, you know, what we're doing, however you look at anesthesia, you know, we're using one of those same things. It's just kind of our responsibility to address them if they come up. And I think the main factor is that, you know, we're all dealing with sick patients to start with. I think some people couldn't hear you guys. So if you want to get closer to the mic, there's some comments in the chat. Is it Dr. Anderson that, we couldn't really hear what you, can you just repeat what you said? We couldn't really hear anything. Oh, sure. I was just saying that, you know, it has a lot to do with the situational awareness during the procedure. It has to be a little heightened, you know, awareness of what's going on with your patient, both at the head of the bed from an airway standpoint, as well as the hemodynamics. I think that we kind of already have some level of that in the TATR procedure, even when we haven't had any procedures supporting this. But rather than asking if everything's okay, are you guys addressing the blood pressure? I'll need the provider to manage those episodes. Dr. Shahal, your audio is kind of coming and going. I don't know if you need to be closer or, but we just lost you again. Can you hear us now? Is this better? Yeah, that is better. I think you just have to be close. All right. Sorry about that. No, no worries. So yeah, that's for the inclusion criteria. You can go next. So, yeah. So again, I think adopting a nurse-led sedation at the end of the day gives you the flexibility. So, you know, we work very closely with our anesthesia team and we still need anesthesia for other procedures in the hospital and for other cardiac, on cardiac surgery and cardiology. And I think kind of transitioning from a nurse-led sedation, from monitor anesthesia care to nurse-led sedation and just give us the flexibility of performing these procedures without being limited with anesthesia availability, but also feed our anesthesia colleagues so that they can be doing other procedures in the hospital, which again, in this day and age, it's a very limited resource unfortunately with the volume increasing and our population increasing, that's definitely a challenge that we're going to be moving forward. And I think having nurse-led sedation definitely benefits, have a lot of benefit to that. All right. And next. That was, that's the end of the slides you had. I don't know if you wanted to add some additional commentary, Susan, as to the rollout or some of the work that you did just in terms of forming your teams and getting everyone on board. Yeah, so, and again, just like Dr. Allaham was saying, we also do a good volume of inpatient TAVRs at University of Maryland. So I feel like we had strict TAVR days in the beginning where it was be Monday, Wednesday and Thursday. So this allowed us to, if there was a patient that came in Thursday, we could get their CAT scan Thursday and then do their TAVR Friday without having to wait all weekend, keep the patient in the hospital, wait all weekend before getting discharged. So, helps the patients to get through the system quicker. But, sorry, what was your question, Denise? You wanted me to go over? Yeah, I just wondered in terms of a little bit about how you got the team together and maybe how you put together the process, some of that early team building work that was done to make sure you could be successful. Yeah, so we, like I said, we sat down with our stakeholders, which the majority of was the director, the cath lab nurse manager, and then cath lab charge kind of made it a small team. We developed our protocol, which like I said, I'm happy to share, just to make sure that everybody felt that it was safe. Like I said, we had an emergency backup plan with the cardiac anesthesia team and the cardiac surgeons are in every case. And then we had a specialized nurse from, you know, that works closely with the Edwards team come in and work with our nursing staff. So we did, you know, an educational session where they sat down and talked to the nurses. And it was actually very informal. It wasn't, you know, a protocol or, you know, going over a presentation, you know, it was just kind of, hey, we take care of these patients every day. We'll do a balloon viagiloplasty, which is kind of the same, you know, concept. What questions and concerns did you have? I think the main concerns initially were from our nursing staff was, you know, who is giving, you know, anesthesia can just give a little push of phenylephrine. So who's going to be the one to give the presser if the patient gets hypotensive? So we just kind of took that out of the nursing staff that, you know, we developed also a kit. So all the meds get pulled at the beginning and they have a bag of Levo and then the phenylephrine goes on the table so that physicians will get the phenylephrine if the patient's hypotensive, you know, kind of designating the roles. So, you know, who's going to be doing the pacing, who's going to be administering the meds. We have a nurse that's strictly, you know, dedicated to the patient and giving the medications and making sure that they're comfortable and talking them through the whole process. And then, like I said, you know, initially I think it's helpful to pick very kind of straightforward patients up front that are fairly healthy and, you know, their main problems, aortic stenosis, and that way, you know, it goes smoothly and the staff feels comfortable so that, you know, later down the road, they feel like, okay, let's do this. Yeah, just to add one thing, I think, you know, Susan definitely did a great job when we started with the cath lab. So it was a whole process. It wasn't just the cath lab, it also was the recovery. So when we were doing anesthesia monitored care, we had a post-operative recovery unit where the patient went there and they were under anesthesia care. With our nurse sedation, the patients actually go to the general floor, kind of an intermediate care unit where they are under cardiology service. And we made sure that post-operatively sit down with our nurses and physicians on the floors and make sure that everyone has a similar thing, have the education on how to manage these patients post-operatively, how to follow up on them and make sure that our contacts are there if there's anything needed. So I think the workflow itself was very important to go through. And again, the inclusion criteria, you know, when we started, it was pretty strict. And then, you know, like everything else, it's just a work in progress and you kind of go around it sometimes. And as Susan said, the first, I would say maybe 50 patients, we made sure that, you know, they are severe, not a lot of medical comorbidities, BMI is okay, just to make sure that, and again, you know, it's a learning process as you go through. I think that from an operator standpoint, the main change is that, again, you are dealing with a patient, you're first, you're focused on the operation itself, but again, you're adding that layer of complexity where you're dealing with the patient hemodynamics, we have phenylephrine with us, we administer it as needed, you're giving the heparin, you're checking the ACTs, you're eyes on the patient oxygen, if he needs a mask, if he needs an airway, again, you're giving the calls at that point. So it might be a little bit of a learning curve, but again, as interventional cardiologists, structural cardiologists, we are used to dealing, and cardiac surgeons, we are used to dealing with these patients, sick patients all the time. So I think that learning curve is just the first few cases and you kind of get used to it. One last thing I have to add is that, you know, we looked at this, and again, from a resource standpoint, so we talked about the anesthesia, we talked about the flexibility, I think one of the main things also is the timing and the financial part of it, and I think our colleagues in Texas will talk more about it. I think we both had similar outcomes where we looked at it, and there's definitely a significant financial benefit for the Institute if we transition from the monocular caesarean door to the MAC, the cath lab, the nurse-led sedation, and we found a significant improvement in hospital and procedural cost with no significant change in safety outcomes. This is a paper we're looking at, I think it will be published soon, but I think that's very important to see, and the idea is not just trying to save the money, it's to reallocate that resource and try to improve our care in other fields of the hospital and cardiology. So I think also the round time for the procedures is significantly improved with nurse-led sedation, obviously when compared with the monocular anesthesia care, so you get to do more procedures in a day with less cost and similar safety outcomes. So it's kind of a win-win-win situation, but again I think the key points, as Susan mentioned, is education, education, education for the staff, knowing who are the patients to start the program with and going there, and for the operators I think it just comes natural to us hopefully as it grows. And for me, again, this is my first year as a structural attending, my first case was a nurse-led sedation case, and I was completely comfortable doing it. The patient did great and they were discharged the next day, so I think it's just a little bit of a learning curve, but as you get used to it, it's a really, really good alternative, and hopefully, we hope to be the future down the road. Very good, well thank you so much for that great overview. I'm going to hand it over now to the University of Texas Health San Antonio and University Health team. With us today, Dr. Ahmed Al-Mulmani, who is one of the Associate Professors of Medicine and the Director of the Structural Heart Program there, and then Dr. Hamada, who is an Assistant Professor and Associate Director of the Structural Heart Program. I'm not sure if I see him on the call, but I know Dr. Al-Mulmani is the lead person here. Also with us is Joyce Arnelius, who is the Advanced Diagnostic Center Cath Lab Case Manager, and Virginia Trevisio, who is the Executive Director of the Heart and Vascular Institute. They, too, were instrumental in helping us develop this white paper. So, whoops, sorry about that. I'm going to hand it over to Dr. Al-Mulmani. All right, well thank you for this opportunity, and please stop me if my audio is a problem, or my team maybe can call me or text me if you guys can't hear me well. You know, Dr. Al-Mulmani is here with the group in the conference room. I take credit for the presentation. The team in the room take credit for developing a lot of that framework around nurse-less sedation. Dr. Hamada championed it. Joyce, you know, your case manager and nurse educator helped educating the nurses in developing the protocol, and Virginia and the leadership in the Cath Lab and HVI helped us to actually push that through. So, you know, I just want to take the opportunity to say thank you for getting this going, and this is the reason why we're here today. So, I'm going to talk about why we thought about it when it started, and how we looked at the literature a little bit, and how we implemented that in the space in our program, and also developed our own screening criteria protocols, which mirrors a lot of what other people are using, because we use the same, you know, data points from the publications, and also how the room looks like now, and what effect did that have on our program. So, can we go next, please? Okay. So, why did we think about it? You know, it did seem like it's the nature evolution of TAVR, because, you know, six, seven years ago when we transitioned from general anesthesia to MAC with anesthesia, now what's the next step? You know, this is becoming more and more of a Cath Lab procedure, like Denise showed. Like, more and more cases are done in Cath Labs, rather than ORs or hybrid rooms, and, you know, people are getting more comfortable with it. Procedures are getting more reproducible, equipment are getting smaller, catheters and sheets, and, you know, we are used as an interventional cardiologist doing MPLA high-risk PCI with nurse-led sedation. Why not TAVR? So, that co-existed with, you know, real anesthesia shortage, and especially here in San Antonio in 2022, right, you know, and that, you know, time after COVID when we didn't have enough anesthesia support across the board in all the hospitals here. So, you know, we started thinking more about this. We needed to expand the TAVR program to other days and utilize the main TAVR days where, you know, mostly we have anesthesia TAVR Thursday to do the higher complex cases or, you know, cases that does require anesthesia, and also reduce room turnover and, you know, improve utilization. So, it felt like a strategy that will help with better resource utilization and increase patient access and improve workflow. So, we started looking more into it. Next, please. So, other benefits we thought about, you know, again, cost-effectiveness. Could that reduce the cost of the procedure and, you know, expand schedule flexibility and also give the anesthesia team more time by reducing the burden on them in the cath lab to go to help in other cases, more complex cases, surgical cases. Can you go next, please? Okay. So, here we started looking at literature and looking at multiple data points. Just keep clicking. I think there are like three more, you know, like some multiple studies showing that there's basically no difference in quality and safety here, you know, in terms of complication rate, mortality, or stroke, or, you know, and there's no difference between a minimalist approach between a minimalist approach or nurse-led sedation or, you know, MAC sedation or general anesthesia. So, we know it's safe and it works. Go next, please. Keep going. One more. Next slide. Okay. Yeah, one more. And this was one of the main publications here. So, we started looking at these publications, dissecting into their selection criteria and who's really a candidate. So, basically, something like this is safe. It's alternative access, probably not a candidate. Morbid obesity, not a candidate. Risk of a complicated tower, like risk of chronic obstruction, or there is a barrier to emergent intubation, or patient has problems, a chronic back pain, or, you know, cannot, you know, lay flat on the table well, or, you know, any difficulty with the prior catheter, you know, heart cath, like, you know, we couldn't sedate them with some moving too much during the sedation. Though, these are all things we should take into consideration. And if any of those is a yes, then anesthesia should be involved. And if, you know, it's a straightforward case, we can consider a nurse-led sedation. And then, keep going, please. Next. So, you know, other stuff is surgical care needed. If the patient is, you know, have claustrophobia, or agitation, or any other things, all these things have to be put together. So, we use it to develop our own kind of selection criteria. And I'll show you how we went through that step-by-step. Go next. First, we had a physician champion. In our case was Dr. Hamada. He basically helped develop the protocols, identified the support needed, look at the literature. And he came from a background in, you know, his training at Minneapolis Heart in Emory, where they've had mature nurse-led sedation programs, which kind of helped us transform that into our program. You know, we basically used our nurse educator, Joyce, to help educate the nurses. We did lectures and seminars. We reviewed the policies. And we engaged the cath lab directorship to see how we can refine this and put it in a written policy for us to be able to use. So, you know, one thing is also very important was to get the buy-in of everybody. So, we basically, we have a selection criteria. We've written the guidelines. We sent it for everybody to review. And we had to get buy-in from everybody in the heart team and anesthesia. So, I tell you, one of the most interesting part of it was getting the surgeons comfortable with it. Because as, you know, interventional cardiologists, we're used to doing high-risk PCI and, you know, and pellets and other stuff. Without general anesthesia, the surgeons are not. And this is a little bit of uncharted territory for them. They lack their cardiac anesthesiologist and TE and, you know, the perfusionist being nearby or involved in the case and all that kind of stuff. So, how are you going to convince them? And I think, you know, by doing a little bit of education, show them the data, show them what other people are doing. So, that kind of helped slowly, you know, change the way they think about TAVR. And we did get buy-in from anesthesia right away because they had a lot going on at that time. And they were burdened with being asked to be in multiple places at the same time. So, we did a pilot phase, though. We did the first 10 cases. After all these steps were done, we agreed we're going to do 10 cases with the anesthesia in the control room. So, this is our normal TAVR day where anesthesia, you know, is in the room. So, we asked them, hey, for this case, we screened it and it's good for nurse sedation. Do you mind if the nurses take lead on anesthesia and you guys sit in the control room just to kind of supervise and help? And that was done successfully. They actually all were very happy to help with this. And we completed those 10 cases. And, you know, after that, we started doing cases without having the anesthesia be around. Let's go next, please. So, this is kind of what we developed. This is kind of a screenshot of the first part of five pages. We had to develop our own protocol, basically, which we have it in the cath lab booklet. We put in this work from, you know, the literature review and the data about nurse sedation. We used the pharmacy help to, you know, write the part about, you know, type of sedation given. And, I mean, our nurses are very, very familiar with it. They do it in all cases, but we wanted in a good document how we manage pressers, what are exactly the roles of these providers and how they function in a room. We basically have it all formalized, written down, involving cath lab leadership, educators, physicians, pharmacy, anesthesia. Everybody looked at this. And basically, we have an approved policies with set standard and everything to tell you exactly how this work. And I think this is the second version. It was revised once after we start. We also performed drills. We basically said, what if something, you know, goes wrong? How are we going to deal with this? How fast the ECMO team can, you know, respond? How fast anesthesia can be here? And we did a couple of drills to see how things would go and make sure, you know, we have a special form of announcement in the cath lab to announce like a patient needs help or anesthesia help rather than calling a code blue. We use this and it all kind of fell in place. Like now everybody's familiar. If we're doing nurse lit sedation, you know, on that day, the ECMO team knows that the cath lab is doing nurse lit sedation towers. And the CG team knows. They're in the building. They're on the OR, which one floor above or next door in the endoscopy suite, but they're not in the cath lab, but they're, well, in the building in the close proximity to the cath lab. And if needed, they'll be there right away. This document also talks about, you know, these situations, what happened, precautions to be taken before, like, you know, of course, standard in the cath lab have pads, defibrillators, what medications can be administered if patient, you know, decompensates, you know, talk about, you know, compressors, talk about, you know, blood transfusion and, you know, backup blood in case needed. All these are outlined here. And, you know, if you, with time, your nurses want to go back to it, look at it, see if they need to first improve it or learn from it, it's all available for them. Let's go next, please. So this is the screening tool, and it starts in the clinic. You know, basically, in your valve clinic, you're going to look and see, this is kind of similar to what our colleagues showed, their inclusion exclusion criteria, or, you know, what we developed. So if any of the answer to this is yes, this is our dot phrase, then basically a patient is not a candidate. You know, if all are are no's, then they're candidates. And, you know, some question about high risk for obstructive sleep apnea, you know, you guys know that there are screening tools to do. Go next, please. Bang out, questioner. Also similar, you know, scores, the ASA score, a medal of penalty score, to see if there's any barriers to, or any risk of airway obstruction with sedation, you know, are implemented. And if the score is high, they're not candidates. Go next, please. And, oh, okay, there was a slide, I think I did hide it. It was about screening for obstructive sleep apnea. If anybody is interested, we, you know, we can share it, but it's the, you know, very well known, the Stilt-Bang questionnaire, and we kind of, if you have, if you think your patient, it can be high risk, probably you want not to do nurse-less sedation, because, you know, airway management can be an issue. Now, how do we do that in the cath lab? What's the cath lab layout like, or, you know, what do nurses do? We have two nurses normally in the TAVRs. The one, the nurse one, is the nurse position that the head of the patient, it's the medication, responsible for medication administration and patient monitoring. They reassess their, you know, their alertness, the pain level, level of consciousness, breathing patterns, and see if more sedation is needed, or they have to modify sedation protocol. There's a second nurse who's circulating and helps support, you know, for the nurse administering the sedation, we actually provide them with an extension tubing from the central line we use for the pacemaker for the TAVR, so this way they have, if you need, if they need suppressors, or give medications to support blood pressure, or in case of an emergency, start a blood transfusion, they have a central venous axis. Now, the second nurse is there for support, you know, getting some sometimes equipment to help monitor rhythm and help operating the pacemaker for the case, and if the, if nurse one needs any help, you know, they'll also be there. They're basically sitting, not at the head of the bed, but next to the bed by the defibrillator and the rhythm monitors. So, basically, the way it's done, we have this protocol of how we give the medications, basically, the versed in fentanyl, and reassess the consciousness level and pain level, and they can continuously adjust, keeping in mind the vital signs and the breathing patterns of the patient. You know, they communicate regularly with the physicians, basically, patient is comfortable, everything looks good. We communicate to them, like, okay, we're about to put the big sheath in, so they might feel some pain, so they can be talking to the patient, helping, comforting him during the procedure. You know, they, we tell them when deployment is going to happen, they, you know, be right there. You know, part of this is not really just medicine, part of this is, like, the nurses, they're talking to the patient, make sure he's comfortable, and he's aware of what's going on, so they're, you know, you know, aware when we, they feel the pressure of the large sheath, aware when we're going to paste the heart. Now, with the, you know, in the emergency situation, all rescue equipment should be readily available, anesthesia backup is standby, you know, again, pads on the patient, everything is done, and they've been trained, they had the drills before. Go next, please. So, this is kind of, you know, basic sedation, you know, how we start this. We start low, because some of those patients with severe AS, you know, they have low blood pressure, some of them are sicker than others. Now, we try to screen our patients to do the low-risk, you know, nurse-led sedation, you know, but sometimes we end up doing the patient who are not salvage candidates, you know, if something happens, the surgeon is not going to go in and fix it and do anything about it because three previous heart surgeries or the patient doesn't wish to have it. So we've done cases where not, not really, they're not really a low risk. So we start low with the sedation, but we make sure the patient is comfortable. So we don't, you know, suddenly drop the blood pressure or have big changes in vital signs. And just every three to five minutes. Next please. So this is kind of our, you know, sample from, you know, max sedation versus nurse-led sedation from our program. You know, you see the main differences here. If you look at STS score, they tend to be lower risk patients with nurse-led sedation. You look at their, you know, other, other parameters are similar. They do have a lower myelopathy score, you know, than the bigger patients or a little bit more obese patients that we group with an anesthesia care group. Now if you look at the laboratory procedure time, you see that we were able to see a few minutes during TAVRs and during room turnover. And also, you know, those patients actually had, I don't know if it's like lower length of stay really because the other group has some sicker patients or inpatients who are really sick with heart failure, but, you know, it looks like they had lower postoperative length of stay. Now, if you look at the financial of this, and I got these numbers from the hospital. I'm not sure they're like costs or I think they're basically the lump sum cost of all equipment salaries, everything they charge for in a room. And there is quite a bit cost saving with nurse-led sedation. If you go to the next slide, I did break it down a little bit more and it shows here that basically a lot of cost saving happens because, you know, the equipment used, like supply, which is the third column, average supply cost, it drops because it looks like when the anesthesia team come, they bring with them some supplies and open some stuff that adds to the cost of the procedure. And also average pharmacy cost is lower, which is the fifth column. So the medications anesthesia use, I don't know if sometimes they use a Presidex or Profol or something else that might be more expensive than Versed and Fentanyl. Or in cases, you know, the really sick ones that were under general anesthesia, that's definitely more expensive. But overall, there's cost saving also, you know, average, the one before last is average purchase services. And I think this is like referring to anesthesia services. So they save a little bit of cost in the salaries or services they get charged for from like other departments or so. So this is not an actual, I think, cost, this is how the hospital financial team look at it from cost perspective, but they were very happy with it. And they basically issued about $6,000 or $7,000 of cost saving in TAVR, which is great. I think that was my last slide. Thank you. You are right. Yes. Thank you so much for that terrific overview. This is really just a summary of what we've talked about here in terms of the importance of developing a team from the beginning so that you've got everybody on board and you're ready to go and make sure that you've got a team that's on your side, so to speak, you know, in terms of all players. And then certainly having a clear plan developed and you heard a lot about people's protocols and orders and policies that are preset and people know what they're supposed to do, when, where, how, and why. And there's a clear plan for how you're going to get it done before you even begin to implement nurse subsidization. And then once you're all ready, that's when you begin to conduct some training. You heard about teams that did drills and then had a specific time to go live in which there was a bit of a pilot with some backup support. And then it was really just embed and sustain the change. And so it's really preparing well, executing well, and then sustaining as you move along. So we're going to take time to take some questions. One thing I do want to point out that the protocol from the University of Maryland that Susan shared with us is part of the white paper, Dr. Amamani showed theirs. If there's a little generosity there, if it's okay, we can maybe have that sent through Medi-Axiom and we can share that with the team as well. But in the paper, you'll see that there is this checklist, which really can help teams think through what you might want to do in developing nurse-led sedation. So if you think you are ready or are curious as to if your team is ready, these would be some of the steps that you want to make sure you involve, that you develop. And that's everything from the work group and developing the policies and procedures, collaborating with IT. You saw Dr. Amamani shared what they use for a dot phrase to help record melampotty score, ASA criteria, so that your team has clear documentation and understanding of the nature of the decision that's made for nurse-led sedation, along with those standard workflows, making sure everybody in the cath lab and teams knows what their role is, and then providing the right education and support thereafter, and then recording what your outcomes were. You saw a little bit about what might be possible. So this too is in the white paper for you. So in summary, it's really a promising approach. We think that TAVR procedures, while they are increasing in numbers and the kinds of resources that they require, really can be evaluated through the lens of a team that's in the cath lab and very comfortable with performing sedation for complex patients. Do it all the time with STEMI or with other high-risk PCI and other folks, cardiogenic shock, you name it. So with the constraints that we know are across the country when it comes to anesthesia availability, and the need for anesthesia to attend to even sicker patients, as surgeries that need anesthesia versus procedures that might be able to be completed without the help of anesthesia, this is one way to be able to continue to provide access and procedural capacity and throughput. And it also provides that availability of the cath lab team to exercise their expertise in caring for these kinds of patients and improve the patient experience, but potentially then, as you might guess, reducing the length of stay when patients don't need to recover from general anesthesia. So it really can be a very valuable tool and something one can look at in the future. I'm going to just pause here. We've got a number of questions that have been asked. So I'm going to just address a few of these questions to our panelists, and I'll kind of pose it to some of you, and then you're welcome to also chime in here, if you will. One of the questions we had is a little bit about when and where are the Malampati and the ASA assessments done? How far in advance of the procedure? So maybe, Dr. Almamani, because you just mentioned that, I'll give that to you first and then turn it over to the University of Maryland team to see if they are similar. Yeah. I think this assessment should start in the clinic, you know, and the Dutch phrase that, you know, should, you know, Dr. Almamani put together so you can speak to that too, but, you know, basically in the clinic, you have to identify until the valve clinic coordinator is like, hey, this patient might be a good patient for nurseless sedation. They need to know. You can't wait until the day of the procedure to sort this out, basically. So, yeah, as early as possible. Yeah. Yeah. Susan? Yeah. Yeah. Same for us. I mean, oh, sorry. Go ahead. Yeah. So, yeah, I'm here, like I'm one of the structural cardiologists of Dr. Almamani. So as I pointed out, yes, it needs to be in the clinic. On our structural note, we kind of developed the note to have the checklist automated. So we screen all of the patients. I mean, if the patient is obviously high risk, we just like clarify them. But the key is you have to do it in the clinic and be prepared. The good thing is about structural is you get most of the time to meet the patient before the procedure. There's no ad hoc taffers on these patients. They have the opportunity to go over all the assessment that you have to do. If you don't think about it, you're going to end up like just scheduling your patients for like regular day with anesthesia. But it's very helpful that you have it in your checklist before you proceed. Susan? Yeah. Yeah. We have the same process where, you know, if it's an outpatient, we see them in clinic, we get consents, and then I will do their melampotty and ASA and just drop it in my note that way it's there for documentation purposes. Our inpatients are evaluated, you know, by either the attending or the fellow. And at that time, they'll also, you know, evaluate their ASA and melampotty scores. Yeah, great. One of the other questions we have, sorry, go ahead. The one comment I will have about like if people are interested in like starting this protocol, the very first thing is know the policy in your hospital. You need to get your hospital administration comfortable with this. This is an advice I got from, I mean, I trained at Minneapolis, we did like most of my taffers during training where nursing sedation wasn't like very difficult to do that. But the issue is when you come to a new place, we're introducing something new, you need to get all the key players comfortable with what you're doing. The surgeon, like I got an advice from one of our senior surgeons, you really need to make it through a policy through your hospital. We went to Joyce in Virginia, we thought about what we are doing, what we are trying to achieve. That's how was the very first step. It's very easy to find different protocols, it's very easy to like your nurses, you'll be surprised they are really excellent and they will handle this without issues. Like you just need a little bit of coaching, that's not where most of the work is. Most of the work is getting through the administration process, having your protocol and proving safety. The challenge is, again, again, the surgeon, you need to get your surgeon comfortable with this. If the surgeon is not comfortable, he's not going to buy in, you're going to have some issues. Part of the question, they were talking about emergency, actually, when we started doing this, when you have a seizure, and a seizure usually takes care of your hemodynamic, so it's kind of one less thing to worry about the procedure. But when you start doing nursing sedation, you will be more in charge about what your patient is exactly getting. Sometimes, like certain medication for sedation may drop your blood pressure and you still are in a dangerous situation or you don't have your wire or you need to balloon, so you kind of feel empowered during the case that you know exactly how much your patient is getting of sedation and you communicate with nurses, you are in charge of the blood pressure, you are in charge of all of these things, to a certain degree, gives you more control about your patient. One of the things that we haven't added officially to the protocol, but it's a common sense among us, is critical AS. If you have a patient who is gradient above 50, and you use these patients, you probably need to be either diligent about giving them pressures to start with before you start giving sedation, or having anesthesia help you, or use a minimal amount of sedation until you get there, like, to get across the aortic gulf, because they may have more hemodynamic instability during the case. So that's one thing we kind of, we assess as we have done more and more of these cases. And that's kind of like what happens in setting of sedation of emergency, like, first thing we do is you call for, like, we call it call jewel in our hospital, you'll get anesthesiologists become available, usually the ECMO team will have their circuit and ready to come to the cath lab in case, and then depending on the emergency. Unfortunately, we had one case, we had an emergent, like, injury to the annulus, and anesthesia, we called them, our nurses were excellent, they spiked depressors, they started depressors as needed. We got our anesthesiologist available, and the anesthesiologist, we asked him, are you going to come take over? He said, well, it seems like you guys are doing what you're supposed to do, I don't have to be involved. And he didn't even get involved in the case altogether. Everything, like, your team will become more comfortable, more efficient. It just needs, like, that first few patients, select them carefully, you want to have a good outcome, you need to have a successful outcome, otherwise you're going to set yourself back with the hospital administration, that's extremely important. The goal of this procedure, or the goal of doing nursing sedation is increasing our efficiency, but the main goal is taking care of your patient. You want your patient to go through the procedure safely, and that's your number one priority, like, what you get. So you really need to make sure you select your patients wisely, you talk to them what to expect during the procedure, setting expectation, hey, we're going to do some sedation, you're not going to be knocked out completely. That helps you when you go to the procedure, make things overall easier on you during the procedure. Great, really terrific answer. It's helpful to understand more the in-depth, the need for administrative support, and support of the teams across all roles. That leads to another question that we had, or a series of questions, about a little bit more about the staffing model, maybe more in detail about who is all in the room, and do you have sonographers in the room? Susan, I don't know if you want to take a stab at that for what you've got for support during the procedure staffing wise. Yeah, so, you know, University of Maryland is a teaching hospital, so at the bedside it's the interventional cardiologist, the fellow, the interventional fellow, and then the cardiac surgeon. And then, you know, as I said, we have a nurse at the head of the bed, and either a nurse or RCIS slash x-ray tech also circulating in the room, and then there is a monitor tech. Great. And do you have a sonographer in the room, or are you not using echo? Yeah, we do have an echo sonographer too. Okay, great. Dr. Omomani or Kamuda? Yeah, so basically it's similar. We have, like I showed on the slide, one nurse at the head of the bed for sedation and monitoring the patient, a second circulating nurse, and there's, we scrubbed ourselves, the surgeon, sometimes CT surgery resident or interventional fellow. We have one tech scrubbed in and one tech outside in the monitor, so two techs, two nurses in general. Now, regarding the echo, the protocol we have, the sonographers will screen the patient in pre-op before they go to the room, and right before we are ready to put the valve, and like before we've already crossed the valve, then the measurements, we have the stiff wire, we're ready to take the valve up the aorta, we have a second timeout. And the second timeout, basically, they give a phone call to the, they call the echo tech, and the echo tech basically comes and makes, I mean, the echo lab is right next to the cath lab, so one of them will come right away to scan the patient. You know, in other cases, you know, initially I think there was proposed to give a call to the, you know, OR saying, hey, we're deploying, I mean, but I think that's kind of faded away a little bit. So, on my second timeout, we call the sonographer, then we deploy, by the time we're deploying, the sonographer is in the room and they can look with the echo. Terrific, yeah. Thank you for that description. I believe I saw in the protocols that you have or policy procedures, there's more of a description as well for staff responsibilities. So, I had a question, too, in regards to the medicines that are in your TAVR toolkit. Yeah, you know, either one of you, feel free to answer that. So, Dr. Almamani. So, basically, yeah, we basically use fentanyl and Versed for the sedation with our low doses, 12.5 mics of fentanyl, you know, and 0.5 to 1 of Versed. And, you know, they can't, the nurses are very experienced. They know if that's not good enough, you know, the patient is a little bit, have higher tolerance or so, they can give more. But we start low just because of the reasons Dr. Hamada was talking about, some of the critical S patients, once you give them that sedation, you start seeing the blood pressure dropping. They do have access to pressers, like the bags of, you know, levophed or filanifran, and, you know, dibutamine if needed. So, but these are kind of available, but not open, or, you know, let's say they have the medicine in the cath lab. We do, I've seen some questions in the chat, I was looking about the central venous line that I mentioned. This is the same side arm of the venous line we use for the transcatheter pacing or the temporary pacemaker for the TAVR. We just put an extension tubing, give it to the nurse at the head of the bed, and this way she has a large board access. You know, we put a seven-inch or an eight-inch and use a five-inch pacemaker, so a lot of room around it to give pressers or so. So, whether that's an IJ or femoral, whatever your practice is, you can always give them a side arm of that. So, this is, these are normally the medications, you know, used, and normally it's your cath lab cabinet, really. You have crash cards, you have a cath lab cabinet. It has all these medicines already, so. Yeah, yeah. Susan, anything different for you folks? I know you are intentional about putting a kit together as well. Yeah, and, you know, with the protocol that you're going to share, we have like the kit. So, we worked with pharmacy to, you know, just have like a, you know, we have it for cath, so, you know, when the, you know, patient comes for cath, you just press the TAVR kit and it kind of pulls all the medications that are on the list, but similar to what Dr. Alamati said, you know. Well, I think what's important is some of that cognitive offloading that you've got medicines there ready, pre-ordered, available as one-step meds if you're in Epic or whatever it may be. So, it's easy for staff to proceed as needed or with direction by the proceduralists at the table. So, yeah, really important step. I'm noting that it's a couple minutes after two o'clock. This hour has flown by. If there are some, we'll take a look at the other questions that we may have, and with the permission of those, our panelists here, I may ferret some of them out to you so that you can respond to them as well. Just letting everybody know that, again, that nurse-led sedation white paper is available on the MedAction website. I believe there should be also a link in the chat, and in that nurse-led sedation white paper, there are some, an additional link to, as I mentioned, University of Maryland's protocol that you can look at for some inspiration for your own as well as just a thorough review of many of the points that we've discussed today. Again, you'll receive a copy of today's webinar in your email in three to five days. Feel free to share that and or go on the MedAction website for a copy that you can relisten to. Again, thanks to all of our presenters and thanks to the Edwards Corporation for their generous support in making this all possible. We really appreciate everyone's time today, and we're looking forward to all the really innovations that are yet to come in the world of structural heart. It's an exciting time with lots of good care and outcomes to be provided for these folks. So thanks so much for your time today. We're glad you joined us, and have a good afternoon.

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