Good evening, everyone, and welcome to our webinar for the evening. I'm Eric Sosavsky from the Beth Israel, and I'm proud to be moderating this session on emerging technologies, focusing on renal denervation for hypertension. This is a very special webinar sponsored by Sky with educational support from Medtronic and ReCore Medical. We have a really jam-packed agenda tonight, and I think we're going to cover everything that you want to hear about when thinking about renal denervation and the management of complex hypertension. Our first speaker will be Raven Flora from the University of North Carolina, a nephrologist who really is an expert in the management of complex hypertension, followed by Dave Kanzari, who needs no introduction, an intermediate cardiologist from Piedmont who has helped lead many of the RDN trials over the years. This will be followed by Tai Kobayashi, who's got unique, really, experiences coming from the Penn, where he has had really experience with both RDN technologies and has some opportunities to present to us radiofrequency procedural techniques, and then Ajay Kirtani from Columbia University, who will be talking a little bit more about ultrasound procedural techniques. I think everybody should be aware, or hopefully are aware, of the training pathways document chaired by Raj Swaminathan and Herb Aronow, that are now published in J-SKY, and Raj will be taking us a little bit through some of the training pathways and institutional requirements, and then kind of bringing it all together, we're going to have, again, our University of Pennsylvania group, hosted by Jay Geary and Debbie Cohen, talking about how to build a successful RDN program. Herb Aronow is my co-moderator for this session, and we have the opportunity to accept questions through the chat and Q&A, so please put questions in during the talks. We're going to be saving some time at the end, about 15 minutes to go through them, and Herb will help lead our discussion and really make this an interesting hour and 15 minutes. Again, I just want to acknowledge the support for this activity from Medtronic and ReCore Medical. I also want to thank SKY for all their, you know, really leadership in organizing these wonderful webinars to help our interventional community. I'm going to leave this up for a few seconds here. There's our faculty disclosures that are relevant to the content being discussed. Great, and just for everybody who does, you know, stay on for the full session, SKY does designate this activity for an AMA PRA Category 1 credit, so you do have the opportunity to get medical MOC and AMA credit at the end of the session for your CME, so please make sure, I'm sure everybody registered, you'll get information about how to claim this credit after the session. Lastly, you will have to go through the My Courses link through SKY, which will come to that email, and complete your evaluation of the course to get that credit, so please look out for that when this session completes, and we will make sure you are rewarded for your effort and time paying attention this evening. So, without further ado, I'm going to hand it over to Dr. Voro, who is going to lead us off, really summarizing where we're at with hypertension in 2023. Thank you. Great, thank you, Dr. Zizemsky, for that introduction. Why don't we go ahead and get started? So in this portion of today's webinar, I'm going to highlight the issue of hypertension and why it's so important that we address it with our patients. I'm also going to share some thoughts about the role of an investigational procedure like renal denervation in hypertension management. And before I begin, I just want to thank the organizers of today's webinar for giving me the opportunity to speak today, and also just want to remind you of my disclosures. So let me start by reminding you that hypertension is a highly prevalent disease. In the U.S., it's estimated over 100 million adults have hypertension. This translates into nearly one out of every two adults. The real problem is that the rate of blood pressure control in the U.S. is suboptimal. As you can see from this figure, less than one-third of adults with hypertension have their blood pressure under control despite lifestyle modifications and despite use of effective pharmacotherapies. Here's more data that highlight that there's a lot more work yet to be done with hypertension in the U.S. In this study, the authors used sequential information from NHANES to remind you hypertension in NHANES was defined as a blood pressure greater than 140 over 90. So the authors using this data from NHANES demonstrated that the age-adjusted blood pressure control rates in the U.S. were actually improving in the early 2000s. But as you can see from this figure, the blood pressure control rates in the U.S. peaked in 2013 and have been declining ever since. The last cycle of data collection was in 2018, and you can see even then, more than half of the adults studied did not have their blood pressure under control. So why are blood pressure control rates so poor in the U.S.? Well, of course, the reasons are multifactorial, have to do with patient-related factors, provider-related factors, socioeconomic considerations, among other factors that are listed in this slide. In my practice, in which I see patients with routine and complex hypertension, including resistant hypertension, one barrier to blood pressure control that continuously comes up is the issue of adherence, lack of adherence to lifestyle modifications and poor adherence to pharmacologic therapy. We have multiple studies, including this one, that reminds us that as we increase the number of prescribed medications, non-adherence also increases. So for example, in this study, it was demonstrated as the number of prescribed medications increases from two to three, non-adherence nearly doubles. Moreover, it was noted in the study that when patients were taking five or more medications, the majority of these patients were non-adherent. And of course, single pill combination therapy is certainly a potential way to address the issue of adherence. However, there are barriers to its use, like lack of flexibility in dosing options and even cost barriers. But listen, where there is despair, there is hope. If we can jet get our patients' blood pressures down by at least five points systolic in the office, this has been associated with significant reductions in risk of cardiovascular disease, significant risk of dying from cardiovascular disease. So just five points systolic, so we can do this. So what is the role of renal denervation in hypertension management? Why do we need it? Well, I think I hopefully have shown you that our current approach to hypertension management is not working. If it was, we would not be having such poor control rates. We really do need a solution with no adherence issues, and we also need something to use in addition to lifestyle modifications and our current pharmacologic therapy. As I just showed you in the previous slide, every millimeter of blood pressure reduction counts. Renal denervation has been shown to be effective in over six randomized sham control trials using different devices, different mechanisms. And so far, long-term data looks really good. It looks like the procedure, the blood pressure lowering effect is durable out to three years. And so far, there have been no short or long-term safety events have emerged to date. So as we consider renal denervation in 2023, it is still an investigational procedure in the United States. Many of you may have heard and saw these headlines on the internet in August. What happened in August was the FDA circulatory systems device advisory panel met for two days to review data from the two device companies, ReCore and Medtronic. The majority vote from the panel was in favor of the safety and efficacy of the ReCore ultrasound device, and the panel felt that the benefits of the ReCore ultrasound device did outweigh the risks. And those are the headlines for the ReCore device on the left. On the other hand, here on the right, the panel considered the data for the Medtronic radiofrequency device and voted unanimously that the Medtronic radiofrequency device was safe and the majority vote was in favor for its efficacy. What made the headlines, including the one here on the right, was that the panel did not feel that the benefits of the Medtronic radiofrequency device outweigh its risk for the indications that were presented. Now, the panel's vote was closely divided on the benefit-risk profile question of the device, with the panel chair breaking the time. Again, the panel that met and made these votes was in an advisory panel, and ultimately, the FDA will make its final decision later this year about device approval, so stay tuned. And thanks so much. Great. Thank you, Dr. Vora. That's a wonderful start to the conversation and really painting a picture of why we need this therapy approved in the U.S., both of these devices. I'm going to hand this now over to Dr. Kenzari, who's going to talk to us a little bit about patient selection. So, David, it's all yours. Again, this is a welcomed opportunity to be part of what really, from the beginning of renal denervation, has been a very collaborative, multidisciplinary approach to the global, leading cause of death and disability, ranging from cardiovascular medicine to hypertension specialists, internal medicine, nephrology, endocrinologists, and many others. And while, as Dr. Vora just described, we're awaiting regulatory approval of renal denervation in the United States, we keep in mind that there are many lessons to be learned, both from the context of existing clinical trials and also real-world practice, as renal denervation therapy has been existent and approved and in use in more than 70 countries worldwide. Related to research and grant support and minor consulting on area from the interventional device industry. At present, much of our experience with renal denervation is—and particularly with regard to patient selection—has been limited to selected patient populations with uncontrolled, typically combined hypertension characterized by elevated systolic and diastolic hypertension in these sham-controlled, randomized clinical trials. Notwithstanding, for example, the very large, more than 3,000-patient Global Simplicity Registry that is much more inclusive of broader selection criteria and less selected patients than randomized trials with more esoteric inclusion criteria, still ongoing, identifying patients with more commonly approached in clinical practice to examine the role of renal denervation in selected subgroups—for example, those with chronic kidney disease or isolated systolic hypertension or diabetes. But aside from anatomic and clinical eligibility criteria that may contribute to decision-making for patient selection, broadly speaking, key considerations would include efficacy for the patient and the practitioner. What is the degree of blood pressure reduction? What is the durability of blood pressure reduction with renal denervation therapy? As we now have in randomized clinical trials follow-up through and beyond three years and even selected patient experience from selected centers through 10 years of follow-up after renal denervation therapy, reductions in blood pressure observed with this therapy, what might be the positive influence on reducing adverse events such as end-organ failure with renal disease or stroke or myocardial infarction or heart failure? What is the safety, not only related to the procedural aspect of the procedure, but also late-term safety with regard to chronic kidney disease and preservation of renal function or perhaps what is almost case-reportable of renal artery stenosis? And further, what's very important to our patients is the potential to improve self-reported health status and possibly to reduce the medication burden. As previously identified, the escalation of medication burden is an independent predictor of patient non-adherence. And most importantly, perhaps what's still important for us, other than severe hypertension at baseline, is what might be the predictors of treatment effect with renal denervation therapy? As we'll soon discuss, disparity also exists in the consideration of patient selection between the patients and the providers and their interest or their preference for a therapy such as renal denervation therapy, highly underscoring the need for a shared decision-making process. And to that end, to date, now there have been more than 15 societal and or expert consensus documents, the SCI position document being one such example, that have been introduced to inform patient selection and how renal denervation therapy may be enveloped into existing standards of care. So with regard to clinical considerations for patients to be considered for renal denervation therapy, of course, these patients should have uncontrolled hypertension, which is broadly defined. It may be a discussion point for this group at the completion of our program, but most societal and consensus documents define as having a systolic blood pressure of at least 140 mmHg and or a diastolic blood pressure exceeding 90 mmHg. But these patients considered for renal denervation therapy should have uncontrolled hypertension despite, importantly, lifestyle interventions and the use of antihypertensive medications, which can be very effective, or in patients in whom blood pressure-lowering therapy may be poorly tolerated. And importantly, this definition of uncontrolled hypertension should be confirmed by either ambulatory blood pressure monitoring and or alternative home blood pressure measurements rather than an isolated office visit blood pressure alone. Very importantly, secondary causes of hypertension should be excluded, both anatomic events, or characteristics such as fibromuscular dysplasia or renal artery stenosis, but also neuroendocrine issues related to pheochromocytoma, for instance, or hyperaldosteronism or hyperthyroidism, as other examples. And although not definite mandates or exclusions, however, but in clinical trials, advanced renal disease is poorly studied with renal denervation therapy, as most of the randomized clinical trials have included patients with a GFR lower limit of 40 to 45 mL. Alternatively, ongoing study is moving this number down to 30, a GFR of 30, but there's very little information with regard to renal denervation therapy in patients with more advanced renal disease or those patients on dialysis. Orthostatic hypotension, independent of medication changes, has oftentimes been an exclusion for consideration of patients in renal denervation trials, as has poorly controlled diabetes or type 1 insulin-requiring diabetes, in part because of autonomic instability, and any medical or behavioral condition that may preclude successful adherence to therapies and follow-up, recognizing the importance for both adherence for follow-up and for medications to complement the benefits of renal denervation. For anatomic considerations, noninvasive imaging is a mainstay for patients with uncontrolled hypertension, at least in two regards. One is to exclude secondary causes, such as fibromuscular dysplasia or renal artery stenosis, as previously introduced, but also in selected instances to identify candidacy for renal denervation therapy. As suggested by both the European Society of Hypertension document and the European Association of PCI documents, noninvasive imaging for renal denervation therapy should be performed according to institutional standards, patient characteristics, and local expertise, whether that is with noninvasive imaging using Doppler ultrasound, oral T angiography, or magnetic resonance angiography. Important anatomic exclusion criteria would include, as in clinical trials, significant renal artery stenosis, the presence of fibromuscular dysplasia, and, as the next two discussants will likely address, for using these technologies, at least avoiding treatment in areas that involve significant calcification, atheroma, or prior stenting. Certain trials have excluded patients who have received a renal artery stent in the past at any time point, and more recently, some trials are excluding patients who have undergone, at least more recent, that is within the prior three months, renal artery percutaneous revascularization, but still have persistent uncontrolled hypertension. Treatment of accessory renal arteries is likely as part of the renal denervation procedure. There's limited data with regard to accessory renal artery treatment that may be identified in 20 to up to 30 percent of patient populations, but there's a suggestion, at least, that the additional treatment of accessory renal arteries provides incremental blood pressure reductions compared with treating the main renal artery alone. Renal arteries, accessory renal arteries, are generally considered clinically relevant or significant based on historical data. If they provide, by angiographic blush, at least 20 percent of the renal parenchyma and, of course, meet the IFU criteria for treatment, depending on the modality of renal denervation, whether RF energy or intravascular ultrasound or, perhaps, a study with perivascular drug delivery. Finally, exclusion of polycystic kidney disease, atrophic kidney, renal transplantation, and unilateral kidneys has also been a mainstay of randomized clinical trial data and, therefore, very limited, if any, data exists regarding these special patient populations. Although not related to the renal artery anatomy alone, with regard to considerations of vascular access, aortoiliac tortuosity or disease may preclude successful catheter engagement or challenge catheter engagement of the renal arteries from a femoral approach, and it's important to note that radial access therapies are presently in development with existing technologies and beyond. As I've also implied, patient preference is an important consideration for healthcare providers specific to hypertension. We recognize that medication burden, again, is an independent predictor of medication non-adherence, and as many as one-half of patients with uncontrolled hypertension may demonstrate partial or complete non-adherence to antihypertensive medications, perhaps as a surrogate for patient preference. Indeed, in both Europe and in Asia, observational surveys suggest that as many as one in three individuals with hypertension may prefer a catheter-based treatment such as renal denervation therapy compared to escalation of medications if blood pressure remains persistently uncontrolled. And yet, significant disparity exists between a provider and his or her patient for renal denervation and the patient preference. Providers, for example, more typically are likely to reserve renal denervation therapy for those individuals with very severe hypertension, often exceeding 180 mmHg or more, and or at least on four or more antihypertensive agents. Interestingly, and conversely, the patient interest for an alternative therapy like renal denervation therapy is shared fairly similarly across all ranges of medications and all ranges of blood pressure as well. For patients, as we've demonstrated recently in a discrete choice experiment of patient preference, the extent of blood pressure reduction, the opportunity to reduce blood pressure, and the durability of blood pressure reduction with a therapy such as renal denervation is what is most important or prioritized for patients in coloring their decision-making around device- or drug-based therapies for hypertension. And it's very important, too, then, in this shared decision-making process that we should acknowledge still existing or outstanding limitations with renal denervation therapy, especially with regard to predicting the magnitude of treatment effect or the opportunity to reduce medications. So in summary, the considerations for patients with uncontrolled hypertension and for renal denervation therapy are largely summarized best in another recent societal document from both SCI and the National Kidney Foundation, that patients considered for renal denervation therapy have persistent uncontrolled hypertension despite prescription of guideline-based therapy and inclusive of lifestyle modification and medications, that the elevated blood pressure is confirmed by alternative means of blood pressure monitoring other than office blood pressure alone, as I've shared, for example, ABPM or home blood pressure serial measurements, and that secondary causes of hypertension are excluded. It's a consensus that treatment priority be placed, perhaps, on those with elevated cardiovascular risk and possibly those with uncontrolled hypertension who have experienced a prior cardiovascular event or evidence of end-organ damage. Importantly, we should move forward with renal denervation with patients and their families in a shared decision-making process that—to inform consent that summarizes both the known risks and benefits but considers patient preference and alternative therapeutic approaches. Ideally, and as evidenced by this program this evening, patient endorsement or endorsement, rather, for a patient for renal denervation therapy would come from more than one healthcare provider with an appropriate specialty background. And finally, it should be performed by an experienced interventionalist who has the learned skill sets with appropriate imaging and equipment at that institution, as we'll soon highlight in developing a hypertension program. Thank you. Great. Thank you, David. That was a fantastic talk and a lot to discuss in terms of how we identify patients who are good candidates for these devices. I'm going to hand it now over to Dr. Kobayashi from the University of Pennsylvania to talk us through his approach to performing radiofrequency denervation. So, Ty, all yours. Thanks so much, Eric. Thank you to the panel and Sky for allowing me to present here. It's obviously always really challenging to follow David here in regards to any talk, but I'll do my best. So today we're going to be talking about radiofrequency procedural technique in a case presentation. I'm going to go through my disclosures again, and just to also disclose that all RDN technology at present is currently under investigational use only. So in regards to the procedural flow, I tend to break down the procedure into four different categories. The first of which is the anatomical assessment, which David already went through a majority of the inclusion and exclusion criteria. We do do a procedural planning thereafter, and then we'll go a little bit into the technical portions of performing the renal denervation. And then, of course, remember at the very end, there is another kidney to treat. So to start out with, from the anatomical perspective, we typically perform an aortogram, and what we're looking for is exactly what David had discussed before, is the presence of accessory renal arteries, also some exclusion criteria, including things like fibromuscular dysplasia, as well as renal artery stenosis and aneurysms. You then move forward to unilateral selective angiography, and again, just to ensure that you aren't seeing any exclusion criteria, which were already discussed previously, and of course, recognizing that there is another kidney to evaluate prior to treatment. Once you've performed the anatomical assessment, we move forward to rRDN procedural planning. I'm going to spend a little bit more time on this particular slide in that what we should be thinking about are all potential targets for radiofrequency RDN procedural targets, including all potential targets that are 3 to 8 millimeters in diameter, and one of the techniques that I will be highlighting in this particular talk is the distal-to-proximal approach. And so these arrows are meant to denote all the possible and potential targets to be treated for radiofrequency RDN. In regards to assembling your equipment, what we should be utilizing for these cases, the we typically reach for the IM shape, but you are certainly welcome to use an RDC-1. Remember that these are patients that are going to be undergoing RF, so a grounding pad should be placed prior to getting the patient onto the table. The generator should be in the room, and of course, the use of a 014 nonhydrophilic wire is used for this particular device. It is an RX system. And then the last portion that should be noted is that prior to any ablation, the patient should be adequately sedated, and we'll talk a little bit more about that in a moment. But just to make sure that everybody's on board with the nomenclature, there are four different RF poles on each catheter, and you can see on the cartoon on the bottom left, the spiral catheter, which is what we're talking about, clearly gets its name from its shape, where it creates this helical structure. The four gold poles on the cartoon are meant to denote the electrodes for the RF emissions. The most distal RF port is denoted as 1, and then 2, 3, 4 as you move proximally. So once all of the procedural planning portions are complete and you've assembled your equipment, we'll move forward on performing the renal denervation itself. And so what I've shown you here is an example of a couple of different things. One is that you could see here at the top screen that we've engaged the left renal artery, and we've wired into the distal portion of the branch vessels of the left renal artery. And you could see the placement of all four electrodes, which are all housed in that distal branch. You'll also note specifically that the position of this helical catheter does not cross any ostium. And then just to show you that we do typically try and get to each one of those pre-planned distal branches, and I'm not going to go through every single one of these case examples, but what I do want to highlight for you is one of the unique characteristics about this particular catheter. And I'm going to show you in this inferior branch of the left renal artery is that you can obviously go distal and start treating distally, which is what you want to do, but you can also start pulling this catheter back. And you'll note here that the position of the catheter on the right does cross the ostium. It does go into the main renal artery. What's unique about this particular catheter is that the generator allows you to turn poles three and four off and allowing you to really be selective about treatment distal. So in this particular case, what we ended up doing was we were able to turn off the energy delivered to poles three and four, which remember are the more proximal to electrodes, and we were only distributing the energy to poles one and two. And that allows us to then finish off the treatment to all of the distal branches of the left renal artery. And again, the technique here is really meant to highlight not only the distal to proximal approach, but we were also meant to highlight the fact that you can selectively turn on and off each one of these electrodes based off of the position of the catheter. And then finally, what I meant to show you here on the angiogram on the top is that, again, this is another example of us moving from distal to proximal. And so we've treated all of the branch vessels. And what we're doing here is we're being very selective about what we're actually going to treat and recognizing that we treated all of the branch vessels. We are not meant to treat any arteries that were within five millimeters of either a branch point or a previously treated area. Each one of these electrodes are actually spaced five millimeters apart, so it gives you a certain sense of length here. But we are actually turning off poles one, two, and four and treating just electrode number three, which is that third electrode from the tip, to treat just that subsegment in the distal left. And then as you can see, again, just to reiterate the distal to proximal technique, not only to concentrate on the branch vessels, but we also do treat the main. And you could see here, this is our positioning for our catheter as we pull back into the left main renal artery. And you could kind of tell this sort of spiral shape takes its course as we pull back on the wire. Of course, here's our completion angiogram, noting, and just to kind of highlight that, you know, we don't, what we're looking for any evidence of dissections, perforations, or any damage to the renal parenchyma, which has not been seen in any of the clinical trials for the spiral catheter to date. And once we're satisfied with this particular treatment, recognize that you do have to move on to the contralateral side. And just to, I'm not going to go through this in detail, but just to show you, again, the concept of distal to proximal approach, you'll see that we've positioned our catheters in the branch vessels, and we're treating each one of these with care, recognizing that you do have full control of which electrodes you're turning on and off. And just to also note that this is where the sedatives, just to bring that back into this, each, before each one of these emissions and treatments, we should be adequately sedating these patients for two reasons. One, for patient comfort, but also if the patient does move, it tends to shift the position of the catheter and thus the efficacy of the radiofrequency ablation that you're performing may actually be affected. In those situations, the generator does recognize that the patient has moved and lost contact and will turn off the electrodes automatically. And so there are multiple safety mechanisms that are built into the generator itself, but, and you could see here the completion angiogram of the right renal artery to complete the bilateral renal denervation. Again, that's all I have. Great. Ty, that was a really wonderfully instructive case there, and I agree with every step you took. So very nicely done. I'm going to hand it now to Dr. Kharitne, who is also really, you know, the leader and principal investigator of the ReCore Radiance Trials, and will teach us a little bit about ultrasound renal denervation. So, Ajay, off to you. Well, thanks so much. I mean, first, I just want to compliment Sky for putting on this webinar. I think that for U.S. physicians and those around the world, these types of practical how-to sessions are super important because we do anticipate that these therapies will be approved in the very near future, and so it's nice to be very practical about it. And this just continues a series of what Sky has been doing with a lot of other technologies and techniques. I also just want to say this is a nice bookend talk because you'll see some angiograms, and I'll show you some more that will really help elucidate the role of these specific devices and how we need to be better trained to be able to deploy them. So just at first, this device, the Paradise Ultrasound Renal Denervation System, acts differently. It has a different mechanism of action to the Spiral RF device. It's an ultrasound-based technology that aims actually to create a circumferential ring of ablation, so a depth of one to six millimeters, perhaps a little bit deeper, but also circumferentially, but in order to avoid causing a stenosis in the artery, there's an integrated cooling balloon that cools the lumen. Each sonication is seven seconds in duration, and you just do typically two to three sonications along the main renal artery, not typically going into the distal branches, and I'll show you why that is in a second. Now, for those of you that were involved in the denervation space early on, we were often taught that the ganglia were more proximal, and so we really needed to focus more proximally, but I think what this slide nicely illustrates is the ganglia are further away. So in order to achieve sufficient denervation, you have to be able to reach the nerves, and that's one of the reasons why, if you're going to use a device that is typically deployed in the main branches, you need to go deeper and more circumferentially to really affect the greatest number of nerves in that way. So that's the anatomic basis for this. The reason that's important is, irrespective of device, you need to get a certain number of nerves in order to reduce norepinephrine levels and therefore reduce blood pressure. So irrespective of device, this principle is going to be true. So the way this device specifically does it is it aims to create a circumferential ablation at a depth of one to six millimeters, and so you'd sort of take that schematic of nerves, if you take it in the circle but spare the lumen so as to not cause stenosis, you'll hopefully be able to get nerves within that range. You won't get nerves that are beyond that range. There may be some heat sinks as well, but ideally that's what the goal of the procedure is. The actual catheter itself is a balloon-based over-the-wire catheter. It has a balloon that's centers it and actually applies the therapy uniformly, but then also there's a cooling balloon as mentioned. This transducer takes electrical energy from the generator, converts it to ultrasound, and as I stated before, there's a cooling balloon. This is what the generator looks like. It controls the energy delivery based upon the balloon size and really is a single generator that you can use with multiple balloon catheters, and one differentiating feature of this technology from the one you heard before is that you do have to size the balloon accordingly to the vessel size, and that might mean you have to use multiple balloons if you have various vessel sizes and accessories. This is an example of what the ablation does in the thermal gel. You can basically see that it takes some time and then all of a sudden you'll start seeing this change in color, which is basically heating up of that territory, but the overall ablation is only seven seconds, and what I just clicked on is a real-time demonstration. What we typically see from these procedures, irrespective of device, is that after about four seconds or so, the patient's toes might start moving a little bit, and then the patient, just as was referenced before, might start having some discomfort. The good news with this technology is that at that four-second mark, you could say there's three more seconds, two, one, and then it stops, and so while sedation is important, we don't want patients to feel pain, it's a very short and transient type of thing with this specific device. Now, how do you actually figure out your treatment strategy? I'll show you a couple schematics. You generally want two to three emissions of the mains. You generally are going to ablate the accessory branches as well. There are three millimeters and above, and you don't want any ablations too close to the renal parenchyma because of the depth of heating with this device. These are just two schematics. This is an accessory here. You would do two emissions, one, two, seven seconds, seven seconds, and then you take a different balloon size for this one and do a seven-second ablation. This is another example, two, it's not an accessory coming off the main, it's an accessory coming off the aorta, and we see that in approximately 25 to 30 percent of our patients. You do have to use different balloons, and the prep time is obviously longer when you do that, but the sonication time is quite short. Overall, preclinical data demonstrates a 90 percent reduction in levels. Here's just a quick schematic. It's obviously not this fast. This is sped up. This is a renal angiogram. This is the device. In this picture, you see the balloon inflated. Contrast is given to be sure that you have good approximation of the balloon to the wall, and then you do your ablation. You then bring the device back. Notice there's a wire distally here. It's an over-the-wire balloon with an O1-4 system. You do another ablation, and then you take an angiogram to confirm that everything's fine. Here's the case example of a patient that was treated in one of the studies. There's a pre-procedural CT angiogram. These, for the purposes of the studies, were measures and sized with ablation patterns shown. I don't anticipate that degree of segmentation is going to happen in routine clinical practice, but I do think a fair number of patients will have some sort of pre-procedural imaging irrespective of device. It's certainly helpful. It reduces the contrast load. You don't have to do that full aortogram as necessary, and you can sort of plan your procedure. So in this particular case, you can see the branches are somewhat more distal. So you can therefore do one, two on this side, one, two. Now, if you go too close to the parenchyma here and go too distal, then you can actually potentially injure the parenchyma. So you want to make sure that you're clear of that. And so that's another way that the CT can help, but so can the nephrogram when you take the angiogram. This is just an example of renal angiography. I want to show this case purposefully. This is micropuncture-guided femoral artery access, standard of care. You need to reduce complications. In all the studies, this is a remarkably safe procedure with low rates of complications. We know that if we extend this into clinical practice, we are most certainly going to see things like this, where when fluoro is applied, you'll see where the needle site entered, very high despite ultrasound-guided access. What happens? You remove the micropuncture needle. You remove the wire. You don't think about it. You hold pressure, and then you reaccess lower down so that you get a safe access in an arterial puncture. Really essential part of the procedure irrespective of the device. This is the renal angiogram being done with the standard conventional diagnostic catheter. There is a hint of a stenosis at the origin here. You can see that there. And this is something that we actually interrogated to be sure that we weren't going to be ablating at a stenosis point. The downside of ablating at a point of stenosis or plaque is that you could make things worse. It's theoretical right now. We don't have a lot of data on that. This is a wire being introduced into the renal artery. Conventional wiring techniques, O1-4 wire. You can use supportive wires if needed. You don't actually need to with this device as a whole. It does deliver pretty well. Oftentimes when it has a loop like this, that's actually pretty safe and you can advance it. In this case, it was straightened out and the wires advanced a little bit more distally. Once that was done in this particular case, this is most certainly not a necessary thing, but I thought I'd show an interesting case. Because we had that area in the osteo, we wanted to be sure that there was not significant plaque there or we understood at least what it was. And so in this case, this is just basically IVUS measurements. There is a little bit of plaque. It's not terrible. So we opted to avoid ablating at that site so as to not cause a potential stenosis. Here's the actual ablation itself. Wire here, balloon here, contrast injected. You see no contrast getting past. Therefore, the ablation is put in place. You can see the operator here is basically just making sure the catheter is stable. All the generator is doing all the work. As I stated before, there's a cooling balloon and everything that goes along with that. Then after that's done, the balloon brought back, reinflated with the catheter system, and then the ablation pattern occurs. You don't see anything further at the osteo. This is gonna be pulled back. You then do a renal angiogram to be sure that you're okay. Then you move on to the other side. So that's basically the procedure. So to summarize, how is this technology applied and what's the procedure like? Well, first, it's currently seven French thermal access with conscious sedation. I do anticipate that on the highest order of priority for both devices is a radial-based approach. We know that that's gonna be safer. We know that it's gonna be quicker. And so all the companies are working on doing that. In addition, this procedure is a guide and wire-based system with balloon catheters to advance the main arteries and accessories using standard over-the-wire techniques. It's pretty straightforward. You need to be sure that you look at your distal wire position. You're not using hydrophilic wires, as was mentioned before, and standard techniques with basic sheet guides in the seven French system. The balloons are sized to the vessel. You may need more than one balloon if there's size discrepancies and or accessories. Typically speaking, most of the balloons have sort of one millimeter of tolerance. So if you have a 4-5 vessel, you're gonna use a 5-0 balloon. If you have a 6-2 vessel, you're gonna use a 7 balloon, that kind of thing. There's an external generator which inflates the balloon, introduces cooling of the lumen, and delivers a seven-second sonication. Each sonication is seven seconds. And there's conventional arterial closure with what is typically a same-day procedure. So I hope that was a summary, a nice summary of what this procedure would entail. Obviously, there are other steps to it. I think the patient selection component is super important, and we wanna be sure that we're treating the right patients. We also wanna be circumspect with the data that's been published today, showing such low rates of complications. We know that when we take devices into clinical practice, we are going to see some complications. So we have to be adequately trained to really be able to make sure we can mitigate and avoid those complications. And Sky is obviously taking a leadership role in the education in that regard. Thanks so much. Wonderful, thank you, Adrian. That was really informative. Love seeing those cases. I wanna encourage everyone, again, to put questions in. Again, think about stuff such as nitro. Do we give nitro? And how do you use nitro during the case? Any questions about guide, support, access, whatever you have, please put them in the Q&A so Dr. Aronow can cover these during our discussion period to follow. So I'm gonna hand it now over to Dr. Sumanathan, who'll really take us through our Sky position statement on the training. Yeah, here we go. We're going back and forth here. Training statement and institutional requirements. So Raj, I'm gonna hand it to you. Thank you very much. So hi, everyone. Thank you for the opportunity to be a part of this webinar. My task is to review operator competence, training pathways, and institutional requirements for renal derivation or RDN. I will say that this section of the RDN consensus document that was just published in J-Sky generated the most discussion amongst committee members and what we tried to do was strike a balance between making sure that operators have enough experience to do this procedure appropriately and safely while not mandating requirements that were too excessive or unnecessary and would pose barriers to adoption of the technology, which would ultimately limit access to patients. So we look to see first, what are the recent guidelines? If any, were proposed for procedures in the renal space. There is the recent 2023 ACC AHA Sky advanced training statement on interventional cardiology procedures that includes coronary structural and peripheral procedures. And what they proposed were building blocks for skillsets that would be important in the peripheral vascular space. And they were less granular about minimum volume requirements in general. As you can see here, for initial training in the peripheral space, they recommended 100 diagnostic procedures and 50 interventions, half of which were done as a primary operator. But this document states that this included exposure to all peripheral vascular beds. So that's lower extremity, subclavian and renal. So those numbers were inclusive of all of those vascular territories and did not assign volume specifically to each territory. So if we go back to the last document that was very granular about volume requirements, we would be going back about 20 years to 2004. This is a multi-society task force on clinical competence for peripheral vascular interventions. And here we see the same 100 slash 50 number for initial formal training in peripheral interventions. And specific to the renal vascular bed, the volume requirements were listed as 30 diagnostic procedures and 15 interventions for initial competencies. And no fewer than 20 diagnostic or 10 interventions for maintenance was what was recommended. Now, the volumes of renal interventions in 2004 were much higher than what they are today. And so the committee agreed that present day operators would not meet these historical thresholds for competency in renal vascular interventions, nor were the high procedural requirements from that era necessary for renal denervation procedures, which we know have been associated with very low complication rates and a very favorable safety profile in clinical trials. In addition, in these clinical trials, which RDN safety was established, the providers that were doing the procedures included both endovascular and coronary interventional operators with relatively low historical procedural volumes in the renal space. So with this background, we reached a consensus that renal denervation can be performed by both coronary and endovascular operators, or at least there should be a pathway for both to get trained in this. And that the focus should be on attaining certain skill sets that are specific to renal denervation. And these are listed in the document and here in this table. We also outlined various training pathways to attain these skills, which can be through a combination of didactic modules, stimulations, observerships, direct supervision, or some combination of these modalities. But ultimately the operator should be able to attest to proficiency in these skills. And then after demonstrating proficiency in these skill sets, the operator can then move into the next phase, which is a proctoring phase. And that includes the first cases performed independently by the operator and can be accomplished by an experienced RDN physician operator or an industry sponsored clinical representative. So for interventionalists who are already proficient and credentialed for working in the renal space, we recommend that these folks could just move straight to the proctored phase with a minimum of five cases per device. For operators that do not have prior renal vascular expertise, the committee placed greater emphasis on completion of the RDN training pathways to obtain the required skill sets rather than on a specific volume requirement. But we did think that 10 supervised cases, again, half as the primary operator is reasonable to attest to those required RDN skill sets before they move on to the proctored phase. And we recognized in the document that there can be variability in this volume requirement based on the initial experience or baseline experience of the operator. So institutional requirements were also outlined in the document. Some of the key features that were strongly recommended were to establish a dedicated hypertension program, identify a primary physician stakeholder or champion, having access to a multidisciplinary team, which includes invasive and non-invasive specialists both within and outside cardiology, be able to have the ability to screen for secondary causes of hypertension, and have institutional operators that can assist in management of potential complications. We also need to make sure that the institution has appropriate radiological services, including ultrasound, CT, or MR. Finally, we propose a sample care pathway for a patient to work through the process from initial referral through the procedure and beyond. So I would encourage everyone to take a look at this consensus document for more details on that. And I'm happy to take any questions at the end. Thank you. Wonderful, thank you, Raj. That's really helpful. I think that document is incredibly informative. And so anyone who has interest, it's online, JSCI right now. And there's much more covered that we weren't able to speak about during this hour, but we can discuss a little later. We're gonna end the didactic part of the session with Debbie Cohen and Jay Geary from the University of Pennsylvania, talking about building a renal denervation program in the context of the management of complex hypertension. So I'll hand it over to the two of you. Thank you very much. Thanks for including Penn and Jay and myself in this webinar tonight. We've had a lot of experience working in the studies. I think Jay and I have been working together for at least 10 years and time for almost as long. And we just want to present how we had... My screen is not advancing. Hang on, oh, there we go. So we wanted to just, we've put a lot of thought in how to set up an RDN program actually at Penn. And we've presented to our hospital administration a number of times to try and get support for this because we've been expecting this to come down the pipe for some time. These are our disclosures. So firstly, I want to emphasize, you've already probably heard everything already in this webinar, what I'm going to say, but this is kind of a summary of everything. But this is really a team effort. And you need two different stakeholders. You need your hypertension specialist and your endovascular interventionalist. And really ideally, it's four people. It's good if you have a hypertension program and you have your stakeholder who's really an expert in treating complex hypertension. And then you need your two kind of separate groups and you need your endovascular specialist with experience in renal angiography and RDN as you just heard. And there'll be all kinds of requirements to be certified in that. And then we've already kind of set up this potential program because we have already a complex hypertension program. So we already have dedicated APPs and nurse practitioners in our program. And we think this will be very useful in an RDN program because we're expecting that there will be considerable volume. And so you need a kind of protocolized approach so that we can have a steady stream of how we intake the patients, et cetera. And we also want to incorporate a registry for real world data. So we've thought about it as kind of like how do we look at the patients before RDN, then the procedure and post RDN approach. So firstly, I think Dr. Kandesari already mentioned referred to a lot of this, but it's very important to exclude white coat hypertension because about 25% of people with resistant hypertension when they undergo 24 hour ambulatory blood pressure monitoring will actually not have resistant hypertension. So you don't want to be doing procedures on these people. So ideally you should have 24 hour ABPM and we've done this with all the studies and we do it a lot in our practice clinically but that may not be practical for everybody. So I would say home blood pressure monitoring is going to be very important. And I would say at least five days, twice a day, you'd give your patient or your potential subjects or patients a protocol of how to check their blood pressures at home twice a day for at least five days consecutively so that you can see that you're not dealing with white coat hypertension. Then excluding secondary hypertension is really important and particularly primary aldosteronism because if you look at the data, about 25% of people with considered resistant hypertension actually have primary aldosteronism. So really, really important. And that would involve checking plasma renin activity in serum aldosterone and you're looking for suppressed renin of less than one and aldosterone levels usually greater than 15. And if somebody has primary aldo, obviously you should treat this and not send them for renal denervation. Pheochromocytoma is obviously uncommon. So I wouldn't check this on every patient but if you have any suspicion that they have symptoms such as headaches, sweating, palpitations, I would get a plasma metanephrine level. That's the best screening test. And then I think it is important to get imaging, renal artery imaging anyway prior to the procedure. So at the same time, you're gonna look for people with fibromuscular dysplasia and atherosclerotic renal artery stenosis. With FMD, this is gonna usually be in your younger to middle-aged females, often Caucasian. And there's controversies about what to do but it's really depends on your institution. A lot of these, particularly the doppler renal ultrasound is operator dependent. So you'll decide what's best at your institution, but truly CTA or MRA is gonna be better for FMD. And then atherosclerotic renal artery stenosis, I mean, you'd prefer to know this before. So they probably, if they have significant stenosis, you're not gonna go forward with renal denervation. And again, depends on what's best at your institution but usually these people are long-term smokers, diabetic and vascular pets. And then obviously you should look at adherence and medication intolerance issues because these are patients we're gonna consider for renal denervation or address issues of adherence. And then renal function is important because up to now, the trials have all been done with a GFR of greater than 40 to 45. There are now new trials with looking at GFRs of 30 and above. So hopefully we'll be able to include more and more patients with CKD. So how are we gonna get these patients? Obviously there'll be marketing and advertising but we think a lot of these patients are gonna become direct from the patient referrals themselves because that's what we've seen in the trials because patients either feel like having a renal procedure for the hypertension is favorable or not. So I think this is gonna be largely patient driven. And so we really, what we've set up is kind of a protocol that every single patient will contact the center, they'll be given a list of things they have to send in and then they'll come for their evaluation and whether the APP will probably have a number of APPs working under one MD in the clinic at a time. And everyone should get ALBP which is Automated Office Blood Pressure Monitoring, which we did in Sprint, where you have the, you know, there's a few different machines, but for example, there's the Omron, where you get the patient waits for between two to five minutes, you set it alone in the room, and then it takes three readings, one minute apart. So that way you get an accurate blood pressure, because again, we don't want to be doing this on people who don't need a procedure. And then we do screening labs, including workup for secondary hypertension, if it has not been done before they come. And, you know, obviously things that you would need for a procedure, including, you know, CBC, creatinine, PTT, et cetera. And then imaging, which will have already, hopefully been done as part of the secondary evaluation, or, you know, at least prior to the procedure. And then, you know, if you feel this is a good patient to move forward with, obviously coordinating with the cath lab. And Jay is going to take over from here. Thank you, Debbie. So this is where we come in as interventionalists, after this thorough workup by our colleagues in nephrology at Penn. As has been mentioned by many of the prior speakers, including Tai and Ajay, already ends obviously a low risk procedure, and we're looking at 24 hour or less hospital stays with it. And obviously it's probably not going to be long until there's routine same day discharge for this type of procedure, especially as you can imagine technological innovations, which push towards a radial approach. One process that is going to, you know, significantly influence, I think the promulgation of this technique and the speed of that promulgation will be that associated with reimbursement and costs from a hospital level. There are a few things that are not known yet about RDN. There are probably three key ones in terms of that. The first is the cost of the device or devices that could be approved in the near future. Well, we don't know what that price is. And while that may change over time as new entrants come into the market over many years, it's likely that pricing will have an impact on the promulgation of the technology. But obviously with price, the other piece of it, that comes out is reimbursement. And there's two pieces to reimbursement. The first is the CPT codes attached to the procedure. Those don't exist yet. We've modeled out here some CPT codes associated with, you know, a renal angiography and stenting, which we think is a procedure that has a lot in common with RDN. So you might imagine that from a professional fee standpoint, CPT codes that look like this may be what you will see. But then again, we don't know that for sure. What's equally important to the CPT codes is the facility-based reimbursement associated with that. CPT codes will map to what are called, initially at least, what are called ambulatory procedure codes. These are codes that denote reimbursement for outpatient hospital procedures, which is what renal denervation will be initially. It may well move into ambulatory surgical centers and other environments, but still with similar coding schema, most likely. These APC codes and where renal denervation fits into that schema for an endovascular APC code has also not been determined yet. So from a facility standpoint, they certainly will be balancing cost of the devices versus those APC codes. So these are interesting issues to keep your eyes on. They go actually beyond the FDA approval and towards what insurers, including CMS, will have to decide and could have significant influence on the development of the field. Moving on, we have, Debbie mentioned that what we like to do then is have follow-up visits after the procedure as well. We usually have an early follow-up and these are in trial patients. And then again, with checks of ambulatory blood pressure to see whether the procedure is working. In trials thus far, there have been super responders, there have been non-responders, there have been a grand majority of people that lay somewhere in the middle. So I think future research will delineate who is more likely to fall into those categories. But right now, continue to watch patients to make sure that their blood pressure is under better control after renal denervation and has an important role. And this also is managed in our case at our nephrology clinics that we work so closely with. And you can see some of the steps that are taken there. When this goes out into practice, I think it's highly realistic that you'll be co-managing this with a variety of referrings with an interest in hypertension as the procedure scales over time. And then finally, to get to issues related to, if we go forward one slide, there is a potential, obviously, for us to have post-marketing surveillance happen and happen in a way that's rigorous. And we've seen this in other procedures run by various societies and professional groups, and then also sponsored sometimes by industry themselves. But registries that look at how patients respond in the real world have been formed in Europe, but how this happens in the U.S. may well be different. So we look forward to participating in those types of endeavors. And I'll just add that all the AHA hypertension centers, we're actually getting together to try and come up with a protocol for everyone to follow the same time points where we collect data, blood pressures, renal function, do imaging, et cetera, so that we can together form a large group of experience for real-world data in the U.S. Absolutely. The standardization and harmonization of both data elements and endpoints and time points of assessment are extremely important. So David pointed this out several years ago, and we found it to be very true here at Penn, that the key aspects of building an interventional hypertension center of excellence is that identifying both the champion in hypertension and a champion on the interventional side. It's likely that these are gonna be two people or more who need to work really closely together to promulgate this technology to these various other areas, which involve some of the things I've mentioned, the registry, payer engagement, referral groups, et cetera. And I'll leave it to Debbie to close out. So just, this is really a summary slide, but just really thinking about firstly where, when you're thinking about this for your center, where you're gonna get your patients from, you know, social media, that plays a big part, physician referrals, self-referral, which patients, probably patients with resistant hypertension, increased cardiovascular risk, and then you're gonna get those patients with adherence issues and medication intolerances. And then, you know, setting up a AHA hypertension center, I'd highly recommend, and I just checked, there are only 28 AHA certified centers, so there are not that many in the U.S. actually. And then, you know, having your two distinct parts of the program, doing the workup, you know, as we spoke about initially, making sure there's no secondary hypertension, all the labs, you know, making a judicious decision before you're sending someone for the renal denervation. And then, you know, the follow-up is important. And as we said, registry. So really, I think bottom line is, you know, we want to do this in an ethical way so that, you know, we have fairly rigid criteria to start, and once we have real-world data, you know, we may change the types of patients that we think are, you know, eligible for renal denervation, but I think this is a good start. Wonderful. Well, that was a really nice overview. I'm gonna hand this over to Dr. Arenow now to lead our discussion for the next 10 to 15 minutes. Thank you, everyone, for your wonderful presentations. Eric, thanks to you, and thanks to all of our speakers. This was, honestly, it was just incredible. It was a whirlwind tour in the field, and I feel fortunate to have been part of that. So I want to start off with questions in the chat. We have one about what to do after a renal denervation procedure in a patient who maybe doesn't need as much in the way of any hypertensive meds as they once did. What do we peel off first? Debbie, do you want to take a crack at that one? So, I mean, I would kind of equate this to, for example, patients with primary aldosterism. We send them for surgery, and then what we do because they respond well. So I think, you know, you just, you peel off the meds one by one. Obviously, you know, you don't start, you don't just stop a beta blocker, for example, but, you know, a lot of the meds you can stop, you know, easily. So what, I mean, I think would, you know, the best thing to do is, for example, straight after the procedure, you hold the meds, and then, you know, if they're on four or five meds, you send them home, like on two, and then, you know, you have to have close contact with the patient, and then, you know, you add back sequentially as needed. But hopefully, I mean, we can reduce meds. We've got a very polite group here. Ajay, I see you have your hand up. You had a question or a comment? No, I was just going to say, I think what's really important to emphasize is what's the starting blood pressure, and where does the patient start at? Because if the patient is super hypertensive in the beginning, it's very unlikely that they're going to be controlled without medications. And so in those cases, you would likely just continue the medications, and you'd expect a drop of the blood pressure within the normal range. And on the other hand, if the patient is closer to the level of control, then that patient is more likely to be controlled after a denervation procedure, and could actually deescalate. So that starting blood pressure is super important to anchor expectations for what you think may or may not happen after a denervation procedure. No, I completely agree. But also, just to say that patients with the highest blood pressures do seem to have the most response, but even still, you know, if you're starting with 180 and you go down to 160, you still need a lot of blood pressure medication. Eric, you had a question or a comment? Yeah, so just maybe a thought to Ty or Jay. When do you guys in your practice start to observe the blood pressure reduction effects of renal denervation? Is it the post-procedure holding area or several weeks in the clinic? You know, when have you at least seen when it has been effectively the changes in blood pressure? Thanks, Eric. I'll take this one, Jay, if you don't mind. But I tend to actually, prior to taking the patients into the cath lab, I always do try and set expectations for folks, recognizing that a lot of the studies that we have, all the sham control trials, are looking at months down the road. And so I always tell patients, don't be discouraged if tomorrow morning, you know, you check your blood pressure and it looks literally the same, that does not necessarily mean that we did not have an efficacious RDN procedure. And so to your point, Eric, you know, I usually don't take too much stock in what the blood pressure looks like the next day, but rather I do look further down the road, whether it's two months, three months, six months. And then ideally, you know, this is a long-term, lifetime problem that we're trying to fix here. So Rome wasn't built in a day and we shouldn't expect the blood pressure to drop considerably in one day. Thanks, Ty. So we have another question in the chat. There is a meeting attendee today who was a Simplicity, presumably HTN-3 investigator, and who noticed that this was a painful procedure, RDN, for patients. And the question is, how is the pain now after, you know, all of this evolution in technology and how does that affect how much sedation we need to use? So David, I don't know if you want to take that one or Ty, either of you. Certainly, I don't think that there's anything much different with regard to discomfort that we can say from patient to patient. It varies considerably in their sensation of discomfort with some patients having extreme discomfort requiring heavy amounts of sedation and in very, very rare cases requiring general anesthesia with different technologies. But with a one-minute ablation with RF energy, for example, it's generally well-tolerated for these patients. And proportionately, the pain medication from individual to individual. I'm certainly aware of cases where there's a great deal of discomfort and then equally as much ones where patients really sail through the procedure without any discomfort whatsoever. Thank you. I'm just gonna say real quick, that's been my experience too, David. But one thing we have done is right before we start ablating we've bolused a little additional sedatives and pain medication just to have a little extra on board. It's hard to predict who's gonna have a larger pain response, but it seems to be beneficial just to, I think Ty made a comment about the movement can change the position of the electrodes. So it's a nice way to just secure a little safer ablation. Thank you for that comment, I'm interested. Address an issue that Jay brought up earlier in the passing that I think is of extreme interest to both hospital administrations and to practitioners. And that's with regard to reimbursement. And certainly reimbursement follows typically FDA approval for technologies with very limited exceptions. There are actually CPT category three codes for renal denervation that have existed since 2013. And for unilateral and bilateral procedures, but they don't have RVUs associated with them. There has been a suggestion of assignment for ambulatory, for AP with the procedure for outpatient, ambulatory outpatient procedures as well. But I think what's really a priority for us very soon, if not now, is to develop a national coverage decision for this procedure so that we don't find ourselves as healthcare providers in battling Medicare for reimbursement and appropriateness for, we all I think are challenged these days by an ever increasing amount of appeals to third party payers for procedures. I see some of you smiling and I think this will really continue to a large extent until we can get national coverage decision about appropriateness for these patients too. David, I'm glad you brought that up. I mean, there's gonna be this window presumably after approval, but ahead of any payment decisions or NCDs. So what do we do during that window? Are the temporary codes that you referred to going to be enough? I mean, how do institutions make decisions about how to roll this out? Take your comments. Jay, curious about yours as well. So maybe I'll just briefly address my perspective on it is that in most instances, fortunately, and in many instances, there is not necessarily a coding for certain procedures in medicine altogether and Medicare reimbursement for them. And so most likely, I think the expectation is that let's just say these technologies were approved tonight and everybody had them tomorrow that we could start doing procedures, but we would be appealing to Medicare for reimbursement for these procedures. And it would be essential for us. And as it is today for other procedures to have appropriate documentation and coding because 70% of the rejections in general are related to inappropriate documentation and coding. And the last comment I would just make about it is that keep in mind that coverage decisions are entirely separate from payment, so to speak. So how much you get paid is determined by the third party with third party payers from an institution or it may be very geographically based on Medicare coverage decisions. But we expect as a breakthrough technology for the existing renal denervation technologies is that they'll have an NTAP, a new technology add-on payment that would at least for some period, but not a guaranteed indefinite period provide favorable reimbursement as well. Thank you, Jay. Any final thoughts on that question? Yes. I think just to kind of reiterate two of David's points cause he covered it well, is one on the CMS side, things tend to get on the radar with CMS if it's a massive amount of procedures being done. And if it's a short period of time where it's promulgating only to select institutions or handful of them, reimbursement is certainly more likely, although the local considerations, even with CMS, especially in this era of Medicare Advantage is really important. From the private payer standpoint, which again now will represent, I think the majority of your patients because it'll be anybody who's not CMS aged and greater than 50% of patients who are CMS aged given what the Medicare Advantage population is. That's all about hospital-based negotiations. And in many cases, in many of our regions, there is a dominant payer. And then frankly, nowadays, there are dominant health systems as well. And this will come to bear along those negotiations. Naturally, I couldn't agree more that a national coverage analysis is absolutely mandatory here to provide clarity because that's the only way that this won't turn into a bunch of disparate type of scenarios around the country, in my opinion. Well, I wanna thank everybody. I think, unfortunately, we're at the end of our hour and a half. And I know I have many more questions that I'll probably have to ask offline. I'm sure you do too. But I wanna thank Eric for a wonderful job moderating and the rest of the panel, Raven Vora, Tai Kobayashi, Jay Courtenay, Raj Swaminathan, Debbie Cohen, Jay Geary. And of course, thanks, Sky, for putting this together and thank our supporters, ReCore and Medtronic.

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