So, I'm giving this talk for Kenny Rosenfield. These are his slides, and I will editorialize on top of them. Kenny couldn't be here with us, but I know he desperately wanted to be. Before I get started, Chris just outlined for you stroke rates at 30 days, procedural stroke rates of 1% in 600 patients between two trials and two different technologies. As a stroke preventative technology, that competes favorably with left atrial appendage occlusion major complication rates, and rates of major complication with PFO closure. So, we are now in a category of things that are done more routinely in cardiology than you could even believe. And I think it's a great achievement. Gary described what he started with back in 93, 94. It's a great achievement to be at this level of stroke safety for device implants. But we can't do that without proper training and facility, and that's what I'm here to talk about. So, Kenny likes to ask why this procedure is different from all other procedures. It's a takeoff, I think, from Passover, right, Gary? It is. Yeah. So, in any event, and that's, that even though, as Gary said yesterday, it's a relatively straightforward, simple procedure to do, there is no room for any error. And so, you have to be on high alert during the entire procedure. When done well, it's quick. It takes five to 10 minutes to complete the procedure. But you have to really understand what you're doing. You have to have a little headroom to manage any alternative anatomy or outcomes with the patient. The procedure uses different types of skill sets, access, filter, and we are doing something in the carotid artery related to expanding a stenosis where we don't have to have a perfect result. In fact, perfect result may be an enemy of the actual procedural outcome. So, in that regard, you have to learn some different kind of analytic skills. And it is a multidisciplinary disease. As I mentioned in my prior talk, I won't go through that again. So, these are the training and credentialing documents that have come before. They started way back in 2003. There was an attempt, I think, with some of these documents to be obstructive. One of them required that you had done 200 carotid angiograms before you could step to the table and do a carotid step procedure, 200. Now, in the days of CTA, that would be malpractice, quite frankly. And so, you can see where that was a blocking move to keep people who weren't doing carotid angiograms routinely out of the system. And the most recent one that SCNI sponsored was this expert consensus back in 2016. Hara Aronow and many of the folks involved at the time took the 2004 version and updated it to this 2016. And most of what I'm gonna talk about today reflects that. So, who should be doing carotid intervention? It's not a specialty-related issue. The knowledge of the disease state has to be understood. You have to understand the natural history of it and what the therapeutic options are, even if they're not yours. So, you have to know what your stroke risk is in for your end-odorectomy if you don't do that in your community. You have to have appropriate skills, 14,000 wire skills, rapid exchange skills, access skills. You have to know what the angiographic angles are. You have to know why they are. You have to understand the anatomy of the vessel before you can really do the angiography. You have to know the, you have to have appropriate training and credentials, and that's part of the guidelines mechanism. And obviously, the knowledge of not only your limitations, but of the procedure. As we already talked about here, there is, we're not born knowing the cerebral circulation. We have to learn that. And you have to learn the variance of the cerebral circulation so that you can manage things like intolerance with flow reversal. Should you take the balloon down when you haven't aspirated, or should you raise the blood pressure? Or should you finish your procedure quickly? Those are kind of the things that have to be learned along the way. So, if we break it down, these are the various skills. They're cognitive, and I've already kind of outlined some of the cognitive skills. You have to really understand the disease state. The technical, procedural, and then clinical skills. And these are the cognitive requirements. I will not bore you by reading them, but I think you can understand that it's not a significant amount of work. Now, we just spent two, two and a half hours yesterday at a brainstorming session sponsored by SCNI, where industry, subject matter experts, academics, and so on sat around the table and tried to figure out what was needed after this most recent coverage decision by CMS to safely encourage and expand crotastenting in the communities we serve. And one of the things we talked about was refreshing this guidelines document, because it's been seven years since this, or seven or eight years now, since this was put out. So, the cognitive pieces, again, I'm not going to go through them, but it talks about issues around anatomy, natural history, follow-up in terms of what you do with medical therapy, and imaging, and so on. And I already talked about that. The cognitive knowledge base also includes when not to do crotastenting, what are the limitations of crotastenting? When we first started doing this, we took everybody who couldn't be endoderectomized, and we stented them, and that was probably a bad idea, because they had features that didn't favor crotastenting, and these are some of them. Again, I'm not going to list them all. The second piece is the technical skill. You have to be able to access patients, you have to be able to get through their arch, to be able to do the angiography, selectively intubate their carotid arteries, pass a filter through a tight or tortuous vessel, know where to place it, know how to keep it there during a procedure, not pull it back inadvertently, know how to do exchanges. All those technical skills have to be done over 14,000th wire. That's not innate to a lot of specialties. And then you have to know what to do if you have untoward events during the procedure that really comes into the cognitive piece, you know, hemodynamic or neurologic events. And not all neurologic events, in fact, most neurologic events are not related to thromboembolism, but may be related to hypertension, stuffed filter, and so on. So it's important to be able to recognize, do your differential and move quickly to solve the problem. I've already talked about this. And then I just talked about this. So facility credentials are important. So in the last CMS decision, there was no requirement for facility certification. We argued strongly that that should be a local phenomenon and CMS agreed, just like it is for robotic surgery. That's not a CMS dictated phenomenon. So bottom line is that we have to take responsibility for that and here are some of the features that have to be satisfied. You have to have appropriate high resolution imaging, advanced human monitoring, a recovery area, and probably most importantly for me is the skilled professionals that work with me in the cath lab. They really need to know what they're doing. They need to know and recognize with you the phenomenon that's about to happen, give the phenylephrine, run in some fluids, have it in their pocket, in their hip pocket, ready to go when you need to. And we're all shaking our heads because we know that if we have to kind of coach somebody through that, at the time it's happening, it's gonna be a problem. So this is critical to a successful procedure. It is a team operation. And then also very important are the QA systems, the data collection, oversight, maternal M&M conferences and so on, where you have peer review to look at your outcomes and assess not just process issues, but also individual competence issues. And I won't go through that. So there are multiple pathways to credentialing. Fellowships will teach it, but there aren't many fellows who have even seen a procedure in the last 10 years, and not many that have access to it in their fellowship training. So other things will be the didactic coursework that we're trying to start to set up here. Observation of cases, proctoring by a knowledgeable person coming into your lab. Industry sponsored mandated training, which is not as common as it used to be. And simulation training, which can be part of didactic coursework. Didactic coursework can be done online, but it really is helpful to have hands-on training, either in flow models, animals, or simulation. And then, you know, I'm gonna end on this one. I think I end on this one, yeah, I do. So the heart team model with valvular heart disease has been a spectacular success. In our institution, we have routine meetings. Every Tuesday, we walk through every patient, talk about the research opportunities, what we're gonna do with them, which procedure, which device, what the risks are, how we're gonna manage them after the procedure, and so on. That was largely dictated by CMS as a condition of payment. That doesn't exist in this therapy, but ideally, that same thing could be recapitulated, and I believe will help not just the patient, but all of us learn more about who we're taking care of and how best to do it. Thanks very much. Thank you.

carotid interventions

training standards

multidisciplinary approach

procedural competency

stroke prevention