I could start with Debbie here. What do you think for, you know, can the hypertension expert be the actual proceduralist doing the renal derivations? I mean, we did kind of discuss this already, but I personally don't think so. Debbie, you're at an interventional meet. I know. That's like the cardiac surgeon. I mean, I think, I mean, you have to have someone who's independent and there's no stake in it for them to send a patient, you know. And so they're going to do it because it's the best thing for the patient. And even if I'm at an interventional meeting, the more procedures you do, the more money you make. So there's a different stake involved. So that's my take. Can I speak a little bit? Okay. We're spoiled because we have you in Philly. But if you're in a rural area, let's say somewhere that you didn't have, you know, really the personnel of folks, we just heard how few people seem to be interested in being hypertension specialists. What would you say about those places where somebody is, the person who's interested most in the disease process happens to be the person who's interventionalist, then it's not a highly populated area. Maybe you have a team, you know. So like you work with, I mean, I'm assuming you work with somebody and, you know, somebody vets them and the other one does the procedural vice versa or something. I mean, there has to be, because we don't want, we want this to be done ethically, in my opinion. You know, I mean, I understand it's a kind of difficult situation, but we don't want every single person who goes to internist one who has a high blood pressure next thing they get a renal denervation. So there has to be some standard. All right, here's a question. I understand Debbie's position and I think all of us up here representing very polarized expressions of our specialty with regard to renal denervation. I mean, for myself, I would say I feel very capable and comfortable doing this, but then again I've been doing this for more than 15 years in the space of hypertension and yet at the same time, if you'd say, well, you need a nephrologist, and I think it should be a multidisciplinary, I think there should be at least two different doctors that are recommending and, you know, referring a patient for renal denervation in general as we've discussed in the consensus document. But on the other hand, if you think about most nephrologists or most endocrinologists or most non-invasive cardiologists, they're not just doing perhaps like you hypertension alone. Nephrologists are seeing most people with diabetes and chronic kidney disease and hypertension is per se, you know, just a fraction of their referrals and equally the same for non-invasive cardiologists. I think, you know, I think whoever it is, irrespective of his or her subspecialty or specialty is that you need to have true dedicated time and commitment to this space, not just I'm going to see you for your high blood pressure, do an interventional procedure and then we'll see in six months follow up. Yeah. I think that makes sense. Like I think there's no reason an interventional cardiologist isn't capable, but I think the real question is what are they going to do for the 90% of the hypertensive patients who don't need renal denervation? And if they're happy to continue taking care of those patients and if they're happy to do thorough secondary workups, then sure. But I don't know a lot of interventional cardiologists who find joy in doing that. And it could be an internist. I mean, it doesn't have to be a nephrologist, you know, I mean, there's lots of people who could do it. Yeah. The field of interventional, it's interesting. And I think at Cedars-Sinai at Penn, you won't see this because we're hyper, hyper-specialized interventionalists. Ty and I barely leave the cath lab basically, so we're very lucky that Debbie takes care of the patients and she's willing to refer to us. But out in the world, you know, it may be surprising for those who are not interventionalists to know that the mean amount of PCI volume in the country among interventionalists is under 50 per year at the last look. So it's, and that's obviously, you know, it's three times probably higher at our institutions, you know, as a mean, with some people probably doing 400 or something like that. And so when you hear that, what that means is that most interventional cardiologists in the country, if you look at the 4,000 that were listed there, are actually general cardiologists first. And that's the history of the field with interventional cardiology being added on. This is a very, the panel here is totally not representative because we're all these cath lab docs who just live in the cath lab. So it's extremely unusual in terms of capturing what interventional cardiologists are doing out there. So to your point, Tiffany, I totally agree that you'd have to be willing to have a longitudinal practice in relation to the patient, but most interventional cardiologists, and you can tell me, I'm sure many in this room are already doing that for cardiovascular disease. Can they commit it to hypertension? I think that would be the expectation, but it's just something to know, a big picture of the field. I'll just add to that, that when we talk about the operator training requirements, it's not specific necessarily to endovascular specialists. So there is a path for a coronary interventionalist to get training in this, and as Jay said, if you look at a lot of the coronary angiographers in the country, they're general cardiologists first. They have a huge clinic panel, they see tons of patients every week, and they have sort of blocked time in the cath lab to bring their patients. So they've been following their own hypertensive patients for many, many years. They've already probably done the referral for secondary workup, got them back, and they're treating them. So in those situations, I think they're totally capable of being the operator and following them long-term. So it just kind of depends. It's kind of situational. So I'll flip the question. Is your specialty defined that you're a hypertension specialist? So you're a cardiologist and we take care of hypertension. Are you now a hypertension specialist or a nephrologist, do you see some hypertension? I mean, we had a lot of thought about this in the Sky document about what's the specialty makeup and what makes you a hypertension expert. And you know, again, I know in all of our training, we have some multi-specialty here. We have different exposure, and to Dave's point, I don't know all the differences between the ARPs. I'm gonna bring that up right now. So, you know, how do we define a hypertension expert? And I'm gonna go to Mike first because you've been doing this for a long. I mean, are you—are we gonna be very specific about this or is this someone who's willing to learn and dedicate their time to it? Yeah. You know, I think that interest and passion are the most important thing and you define it by looking in the mirror. I mean, I had a very wise mentor of mine when I was first interested in vascular medicine who I was looking to do a formal program and was like, if you call yourself a vascular medicine specialist and you do the work, you're gonna become a vascular medicine specialist, regardless of what initials are behind your name. So I really think passion, interest, and time are the most important variables. I do think it would be nice for us to formalize what it meant to be a hypertension specialist. We've tried to do that at the American Society of Hypertension for a long time. That program was not terribly successful in terms of reach. But I think the concept is a good one. I think having a shared foundational knowledge among specialists, whether you're a family doc, an internist, a vascular medicine doc, a general cardiologist, an interventional cardiologist, a nephrologist, an endocrinologist, you know, if you have that interest that we have a foundational—some foundational knowledge that you need to master and some sort of evaluation of that knowledge, I think would be nice, would be helpful for the field, something, you know, the American Heart Association has tried to do as well. It's just never been terribly effective. But I do think it would be nice. So Michael, do you think there's an existing credential that would be appropriate for interventional cardiologists? So there is a specialist designation through American Heart that folks can get. It's a fairly rigorous test. And I think part of the reason that it hasn't been more popular is sort of grandfathered from the American Society of Hypertension, you know, on to the American Heart Association who hasn't really done a great job of publicizing it. And most of the reason is that, quite frankly, there hasn't been a lot of reason for it to exist. There hasn't been this pathway where poorly controlled hypertensives in our communities are referred on to a specific individual. I think, you know, just like I said earlier, that this is a great opportunity for us to develop centers. I think this is also a great opportunity for us to take another look at what it means to be a hypertension specialist and perhaps revive a specialty designation, either American, I won't get into the politics of it, I don't think our current formulation of that specialist examination and criteria are what we need. But I do think it would be nice to have something. But I mean, there is a formal exam and there is a formal process to become a hypertension center of excellence or like a community hospital with a designation for hypertension. So I mean, maybe, you know, groups like SCAR could work with AHA to make it a little bit more accessible and, you know, publicize it. But I do think, you know, if you had the training, then anybody can do that exam, you know, and it is quite rigorous. But I mean, you want the person to know how to work everything out. And, you know, we, for me, you know, I understood my deficits and my trainee who is now my colleague, we had her go through, during her vascular medicine fellowship, a six-month hypertension training program. And so we created this, we had a specialist that was part of this, but then she was able to come and as an early career, you know, faculty member, really take charge of our hypertension program with more competence and honestly more sophistication than our entire cardiology division. So and I think there was incredible value to that, but it wasn't formalized. This was something that we had to create, to generate. And I do think whether SCAR or SVM or other societies, in addition to AHA and, you know, NCAP or whatever it might be, that might provide pathways for this that would be helpful. Yeah, and I think that overall, I mean, this kind of highlights, you know, that we're still figuring this out, like how do we kind of create these hypertension centers of excellence and who's going to be that point person, which kind of brings me to the next question for folks that already have hypertension centers already in line. How are you guys managing your programs in regards to referrals? How do you kind of tell referrals about or even sort of approaching them about renal deprivation? How do you kind of start to manage patients? What's your pathway? Do you guys have one set in place already to kind of manage referrals? Are you sending them back? Are you keeping them? Tell me a little bit about like, you know, I'll ask Michael all the way at the end there. What's been your practice in terms of how you handle referrals? And you know, once you kind of quote unquote fix them, do you send them back or do they want to stay with you? How does that work? Yeah, I think we've tried to really individualize the approach, both in terms of the referring provider and in terms of the patient. You know, I've been in the community now for 23 years. When I first got there, I said, why on earth do we need a vascular medicine and hypertension specialist? What even is that? And, you know, now we're to the point where we're, you know, trying to decrease the number of patients that are referred to our center because we don't have the capacity to see them all. So I would say that, you know, in general, if you build it, they will come. Nobody loves taking care of difficult high blood pressure, except for those of us here on the panel. So if you build it, they will come. And then I think that the issue of referring them back, I mean, we talk about, as somebody else mentioned it earlier, co-management. We use that term all the time. Whether that means that we're comfortable enough to not see that patient back every year, you know, sometimes it is that we're comfortable. Sometimes it's not. We take it on a case-by-case basis, you know, in terms of patient preference. And then knowing a little bit, we've been in the community for a long time, knowing a little bit about who their primary care provider is, if they have one, and whether or not we feel comfortable having them no longer follow up with us. So we try to take a fairly ad hoc and practical approach and really individualize that. We've also tried to put in, similar to what you guys have done, put in pathways within primary care so that the primary care providers not only can provide better care for their patients with high blood pressure, with easy to look at algorithms for blood pressure monitoring and management, being able to send folks to get an ABPM at our center without actually having them seen for a consultation, and being able to have that sort of, just be able to staff message our team and get some advice without having to send patients in. And then a true pathway for who it is we think we should be seeing. I can tell you that if you look at that pathway, only probably about maybe a quarter of the patients who are actually referred have followed that pathway. And I would say three-quarters of them fall off that pathway in one way or another. They're referred for resistant hypertension, they're on one med, but there's a lot of different variability in terms of who we end up seeing. Let's just say, too, that enlisting yourself in the care of these patients is very time-consuming and dedicated. We now get pictures of grandchildren that are sent to us from these people over many years. It's what Tiffany said earlier, is the patients, though, that aren't eligible for renal denervation or aren't eligible for a trial, whether they're referred from an OB-GYN, as you said earlier, or somewhere else, they're not getting, as you pointed out so well, what they need. And so we end up seeing these people, I end up seeing these people just for long-term blood pressure management independent of that, but it's a large commitment to them. And we certainly do it in, like you say, in co-management or cooperation and communication with the referring doctors that we're not taking them away, per se, but it's usually because the doctors have thrown their hands up or feel like they've thrown out the kitchen sink to these patients, and they're looking for some alternative, and the patients are as well. Yeah, we have sort of struggled to get patients to go back, even though, you know, to your point, when a patient has not had their blood pressure controlled for years and has kind of just been resigned to that, and then you finally get it controlled, I've taken a phrase from my heart failure colleagues. They say, you've graduated from heart failure clinic, you know, when their EF has improved and sustained. And I say, congratulations, you have graduated from hypertension clinic, and they're like, what does that mean? I'll see you in three months, yeah. So it's hard, it can be really hard, but I think one thing that is important is making sure that they know the reasons to come back, you know, making sure that if their pressures are not controlled or anything like that, that they do come back. And also, making sure that the—oh, I forgot what I was going to say—yeah, so just being very prescriptive about what reasons they need to come back to the clinic should you need them. And then can I just ask you, in terms of, like, setting expectations for your patients in general, like, are you measuring success as office of solid blood pressures? Are you repeating an ABPM? And you know, when you're talking back to the referring, or you're even speaking to the patient, like, how are you defining, like, you graduated at this point? Is it really just, you've really achieved the 130 or less, and you're good to go in the office? Or do you, like, really, really continue to go rigorous and just do 24-hour ambulatory blood pressure monitoring? Like, how do you measure success? For me, it depends on what their initial metrics sort of look like. So if—I have everybody take home a sheet of paper, track their blood pressures twice a day, and bring that back and their machine back to the office. And if their machine is accurate and, you know, similar to what I'm getting in the office, then I'll take their paper recordings, I'll take their home metrics. I don't necessarily repeat an ambulatory 24-hour blood pressure monitor. If we saw that they had really, like, mass hypertension or white coat hypertension or anything like that, then I might do something more rigorous. But— Just going to add, I forgot to mention too, I'm heavily dependent on an APP as a gatekeeper. And she also is a great person that if I need somebody who needs to be seen in two weeks or one-month follow-up and I don't have that availability that she can see them as well. And we've been doing this together for years now. And so it works very well because she's quite, quite experienced in hypertension. The other thing I was going to mention is there are—some of you may have seen there are models that are some extrapolated from the structural space in terms of communication and apps that can be used for doctors to refer patients, for patients to be followed to survey their blood pressure over long-term that are proposed for this space. But we'll see how that evolves. I remember what I was going to say. I'm sorry. The other thing is a lot of these people are cardiometabolic patients, right? It's not just hypertension that you're treating them for. And so if someone's blood pressure is controlled but their BMI is 45 and their A1C is 8, I'm probably not going to say congratulations. I'm still going to want to see them in a year because their trajectory overall is not controlled. It would be interesting to see what GLP-1 and semiglutide does. That might be added to the blood pressure regimen, quote-unquote, for obese patients. Yeah. Actually, so the way—everyone gets billed on dialysis through Medicare. And Medicare, if you have a dialysis physician, you can't be seen in a hypertension, like by another nephrologist. So I must—they could go to another hypertension program, but ours is all nephrology-run. So they don't come to us. But the problem is dialysis is—it's a different human being, literally. Most of it's volume-related and fluid management, salt. So I mean, I think, you know, we do manage that in the dialysis unit, but in a very different way. So I actually don't think they're really appropriate for this kind of program. Although there is a couple of case reports for renal denervation on dialysis patients that was shown to be effective. So I mean, they haven't even looked at that space yet, but it is a potential in the future. There's also like 10 where they didn't publish them because it wasn't effective. So— Or nephrectomy. Yeah. Although, I mean, we have a lot of patients with nephrectomy. Think like we have failed transplants, they denevated, and they still have terrible blood pressure. So I don't know. I don't know. I mean, we have done bilateral nephrectomy at times, but in my experience, it's not been that effective. So I want to talk a little bit about advertisement and promotion for hypertension programs and then also for this potential therapy. And it's a two-part question because there is hypertension awareness and promotion for hypertension center, and then there's also recruitment for potentially an intervention. So maybe I'll start with Jay in the latter. You know, we're enrolling in a firm right now. What are effective strategies for recruitment of patients who may be really good candidates for renal denervation that may not come through your hypertension program or come from alternative referral pathways? Yeah. You know, it's interesting that—and Debbie taught us this and has mentioned this several times to us over the last few years—that actually social media, this is a place where it seems to have been quite helpful. There's a lot of patients who intuitively understand that they have high blood pressure. They can measure it, whether they have a cup at home or they go to the pharmacy and use it. So they may be aware of it or maybe they've seen a primary care doc. So this is one element of their medical care that a lot of patients seem attuned to in a personalized fashion. And then where patients are is on social media. So that seems to have been a key reason why Debbie's running a program that has enrolled so rigorously in the studies. Also, you know, another point is, I mean, I think, you know, generally your health system should advertise your hypertension program, you know, and bring people in that way. But I think for renal denervation, there's a lot of people who are going to want a procedure and irrespective of their blood pressure, and there are a lot of people who will never have a procedure. So that's why the social media is a very personalized outreach and then, you know, that's why those are the patients that come and actually want to do it, because you can pitch it to your patient. But if they, you know, they people would never even consider a procedure for their blood pressure. It's kind of a waste of time, in my opinion, you know, where it's like through the social media or whatever way people, you know, there's like some kind of media attention to it. You're going to draw in the people who having difficulty control blood pressure, who would consider such an intervention. Yeah, we're running the same thing. I mean, we've had a lot of success through some internal referrals, but we are already seeing a lot of patients come and express interest because of feeling like they've been lost in the system. There's nowhere else to go. And this is something that's desirable to them. I was just going to say, I think we have to be two-pronged, right? I mean, there are a lot of people that aren't seeing their primary care physician regularly. They may not be in the system that even if we do a really good job socializing this amongst our colleagues and educating everyone that we may never see that referral, right? So, I think it would be wise for us to adopt a social media strategy around this. I was just going to say that there's really two different phenotypes that you get from social media versus physician referrals. And it's exemplary of the data that I showed earlier that the doctors are referring the patients with very extreme hypertension and the social media is attracting people on zero to few medications. So, it's somewhat bimodal that you don't commonly see the patients coming through social media who are on five antihypertensives and are 200 systolic. They're coming from the doctors. It's a different population coming from social media. I think that's a really great point, David. We're here because of renal de-energization, right? That's what sort of was the impetus for having this session. And so, we've been thinking a lot about the technology. But the wonderful offshoot from all of this from a public health standpoint is it's going to make us all so much better organized around treating, you know, evaluating and treating hypertension. So, yeah, I mean, as an operator, right, so that patient who calls up or emails or texts or whatever, you know, sends you a WhatsApp message that, you know, they're interested and glad that you're, you know, that you've got this program, that patient may never make it to RDN, but they may make it to the hypertension center or to someone who can care for their hypertension. And maybe they wouldn't have otherwise. I still think that's a great thing. Yeah. I was just going to say that it's interesting because the promotion for the RDN and promotion for hypertension clinics are gonna feed off of each other. So we started off talking about RDN, which is a technology that's gonna, we showed it can reduce blood pressure by 10 millimeters of mercury. And to get that organized, everyone's gonna start building better hypertension clinics and centers. And Tiffany just showed us data that her hypertension clinic by itself has reduced blood pressure by 20 millimeters of mercury. So just having the technology is gonna force us to kind of regroup around hypertension management and see these significant drops. But there's still so many people in that clinic that are not perfect yet or not at goal and they may need that adjunct with RDN. And then together you get, you know, who knows, 30 point drop. You know, one thing that we've also noticed is that, you know, when folks, when patients are a little bit reluctant, they actually turn towards their, you know, trusted provider to see what they think about renal denervation. We had a recent case where we thought a patient was a good candidate for renal denervation and they spoke to their general cardiologist and the general cardiologist, again, you know, remembered the 2014, you know, the simplicity and was not up to date. And again, you know, this is where we need to educate, but nonetheless, how do you guys strategize behind, you know, getting the general cardiologist, internist, whoever is the primary caretaker for their patient's hypertension to buy in to the idea of renal denervation? I think it's gonna be a big obstacle that we're gonna have to face here. How do you guys, how do you guys, I'll just, I'll throw this out to David. You know, how are you gonna deal with this from a Piedmont whole systems perspective about this? Yeah, I think I'll start even broader by saying a few years ago, I saw all my patients getting vitamin D levels. And then the next thing, you know, everybody demands getting this testosterone level check, right? And this is all coming from the American Academy of Family Practice, right? Or the, you know, American Society of Internal Medicine. Like, you know, they come out one year and they're like, this year we're gonna do this, right? And this year we're gonna do that. And then, you know, and I, and so I think that this is, you know, this is a time where we need to intervene with education for these broader societies in educating first line front, you know, frontline healthcare providers, whether they're APPs or whether they're internists or family medicine doctors as well. For us, it's now, you know, we're a bit unique because it's built into the system, which is given our longevity and history with renal denervation trials. But still, and, you know, we work hand in hand with nephrologists and others from the region, from the state, from multiple states for patients coming in for consideration of renal denervation therapy. And again, not all of whom are eligible for it. So, you know, we have this problem with technology in the cardiovascular space where we have a great breakthrough technology, and I'll give an example of TAVR. And it goes first to those who may be the most resourced, heavy patients in the high volume, big city centers. This is a condition, hypertension, where we know those who have the worst outcomes and the worst control are those who are underserved, tend to be more under-resourced areas, tend to be lower socioeconomic status. How do we take a technology that potentially has a really important benefit for a population that's been ignored or under-cared for and make sure it reaches them? I mean, again, and Tiffany, you probably brought social determinants of health into a conversation where it doesn't get brought in enough. What strategies do we need to start thinking about? Because that's one thing I worry about with this is I work in the middle of Boston. We have a very mixed population that still is biased towards a well-educated, well-resourced population. And that isn't gonna represent those who may have the biggest gain from this technology. This is for everyone. That's a great question, something we definitely need to think about. I mean, I think kind of like you were alluding to before, patients are gonna go for things that their trusted providers recommend. So I think really reaching out to people who take care of those populations. So primary care, I mean, we all, all of our centers know what areas are most heavily serve that population, reaching out to them specifically. Or we also know things like the barbershop study, right? Where we reached out to people where they were and in a situation where they felt comfortable, you know, getting key community leaders who can buy into the strategy. Because I think one of the things that's gonna be challenging is there is more sort of medical apprehension or lack of trust in those populations oftentimes. And then you say, now I want you to do a procedure. You know, I think it's gonna be really important to participate with people who are able to sort of give them trust and not just, you know, come at them one time, never met you before and say, hey, I'm gonna treat your blood pressure with going, putting a catheter in your kidney. Well, you know, you ask Eric about, and I'm suggesting we move to societies like internal medicine and family practice to educate them. But maybe you circumvent the doctor altogether. So how many of you would support a commercial for renal denervation? You see it for Eliquis, you see it for Zempik, you see it for everything else. How about a commercial for renal denervation? There's not many things that people lend themselves. It certainly lends itself more to a direct-to-consumer campaign than a percutaneous LVAD. I've seen that. I've gotten that, yeah. When you get off at Logan in Boston, you've seen Impala advertisements, so yeah. You know, I think it's a very, yeah, it's an interesting question. I think a lot of it has to do with what the messaging is. And I think the same thing when you start talking about underserved populations, where you start talking about primary care providers who may be somewhat distrustful of the system that they feel is taking advantage of them where people are being referred for reasons or taken advantage of reasons of revenue rather than for reasons of good clinical care. So I think all that messaging, right, whether it's to patients, whether it's to societies, whether it's to individual providers, I think as long as we're talking about uncontrolled high blood pressure, right? We're talking about this epidemic, this failure that we have in our delivery system where 50% of patients are uncontrolled. Is that like you? Is that like your patients? And here is this suite of services that we have in your community to help with that. I think we all win with that strategy. I think when you start seeing commercials for, yeah, let's put, you know, go ask your doctor about renal denervation, I think that that has the opportunity to turn off certain segments of society and some of our stakeholders. So I think we have to be careful in our messaging. And once again, I think that's why this is such a really important workshop. You know, how can we talk about this in ways that help our communities, right? In ways that work towards better blood pressure control in a multidisciplinary fashion, rather than make people feel that we're trying to increase the volume of a particular procedure. So it's all, so the answer is yes. I think it's just the messaging. Yeah, that's what I was gonna say. I mean, you know, the companies need to support a session like this, like ACP or something like that, where you get the message out, because that's where those are the people that really take care of the people with hypertension. Yeah, and I think we've already seen that a little bit. I've spent a lot of my career talking to primary care and I get asked to speak about resistant hypertension all the time. I don't get asked to speak about renal denervation, right? That's not where, why you get asked to speak, right? You get asked to speak about this problem of uncontrolled resistant hypertension and what tools do we have, and this is one of our tools. Every talk about resistant hypertension for the last seven or eight years, I've included a section about, you know, this investigational procedure and sometimes others. So I do think we have an opportunity for outreach, but once again, I think we have to be careful in what our messaging is. It's not a session for AAFP on renal denervation, it's a session on poorly controlled blood pressure and, you know, have different stakeholders come in and speak to that, in my opinion. I think one thing that we have to even take a step back, though, is think about adequate enrollment in the clinical trials of that patient population. You know, if you want to go to black and brown people and women and say that this is safe and this is something you should do, especially when they're the most represented people with the disease process, we need to be putting in efforts to make sure that those people are being enrolled in the clinical trial so that we can wholeheartedly say it is safe and effective for you. Yeah, and this is a huge, the FDA is keenly in tune with that mention, and so there's studies, Jay and I are on one, a peripheral study where there has to be 40% enrollment of either women or underrepresented minorities to maintain your ability to enroll in that study. And so, and the FDA is deeply invested in that being part of future pathways for clinical trials of any type, but in particular those where there is a large presence of a condition in an underrepresented group. And so I think, unfortunately, that this is a newer conversation that should have started a long time ago, but again, that's partly why I prompted this question is as we move this technology forward and through the FDA pathway, you know, these are the things that everybody's going to want to be hearing about is what is the strategy to get this to the population most at need? And this is a really great test case because we know who that population is and they are hard to reach. Michael, I was just going to respond to your comment. I'm trying to think about how to say this in the most politically correct way. No, so hypertension is not new, right? It's been around forever and the need to educate around it has been too. And so my concern is that we could put together a great symposium, but nobody's going to come because it's the same old story. I think even though it's not about the technology, that's sort of a hook maybe. And maybe it's a hook for some people because those providers think, oh, that sounds really cool. I want to hear about that along with everything else that we're doing for hypertension. Maybe for others, there's some animosity to like, well, that's crazy. Why would you treat hypertension with a device? I can fix it with meds and lifestyle and everything else, but whatever it is, it's a hook that may get people in the door. So I think we have to use that to sort of attract people to the educational symposia that we might put together. Just one person's bias. I don't know. Yeah, and I'll give credit where credit's due. I mean, I think Medtronic and Rucor have done a fantastic job. That's why we're here talking and spending money on a therapy that's not approved. The whole last several years has been about the infrastructure of a hypertension pathway and program and creating a community to bring this technology to the space. And so exactly in that same setting, I think that's been very valuable. I think the key now is to make sure that continues and I have full confidence it will, but I think that is an area that has been particularly strengthened by the long pathway to this technology being approved. Yeah, and talking about pathways, obviously some of the stakeholders that Tiffany did bring up were some of our administrators. And I think it's really important to continuously have buy-in from the administrators, but that can be challenging in various different institutions. Jay, how would you go about starting a new hypertension program, aligning the right stakeholders and administrators? Yeah, to even cut through and make it not really targeted administrators, it's a reality of the healthcare economic landscape right now is that if you're coming with a new procedure, it's not the same landscape as it might've been 20 years ago when you could bring it in on the strength of, oh, you're on a podium at Sky, you need something new and now it's on the table for you. And why don't you try it out? No, there's huge value analysis that goes into anything that comes in to a health system. And so the concern that I have is right now, we obviously, it's not approved and there's no reason for us to know everything right now, but we have a lot of holes in our knowledge about the economics of this at the hospital level, massive holes, and they're preventing, kind of planning for things and they're probably gonna slow the roll out of this after it's commercially approved is what I see the writing on the wall right now, given where we are. Specifically, where are some of the knowledge gaps? Well, there are several that where you wanna start with is hospital contribution margins. We're gonna start at the hospital margin level. Don't worry about the docs and how much professional fees are coming to them. That has some impact, but really what matters and who the true gatekeeper is, the hospital willing to invest to buying the catheters, the devices, putting them on the shelves, and then also potentially investing in a program to grow that. And we don't know, first of all, if after approval, whether there'll be new technology out on payments for this. And even if there is, they will expire at some point. So you need to take into account the margins with that potentially present, if it's present, and then potentially not present after the expiration. And then we need kind of realistic numbers on the cost. And the concern I have is that there has been a history, there's an incentive, and I will not profess to be an expert on the medical device side with how to price. But you guys saw that I've had enough dealings that I've got disclosures now down to 14 font on my slide. So in that sense, I kind of, a lot of folks I've worked with over the years, the natural tendency is to say, let's price at a high level, let's let the payers come up to us, especially when it's such a novel and transformative technology. Let's do, for example, what TAVR did. Let's make this a loss leader for the first few years. The key concept there to understand where the difference is, remember that when TAVR is the loss leader, the reason why hospitals have to do that is because they think it's a necessary component of one of the most profitable things in their hospital, which is cardiac surgical program. And it's gonna lead to more AVRs, and it's an existential problem if they don't have a TAVR program for the rest of what's one of the most important parts of their hospital. That's not how a hypertension program is viewed right now. It's not viewed as like, let's take a loss leader in hypertension. Those aren't patients that have been labeled as folks who are bringing massive margin to the hospital. So for the folks in industry here, I would think really carefully about those concepts, and then try at least to the sites that you know that are gonna be online soon. Let's try to get some information in folks' hands to work with you. Because if you don't have us with you working through the administrators, I mean, they don't know either way what's gonna be happening there. And we really need to be able to project those margins. Yeah, I thought Jay was talking about shockwave for a little bit. Yeah, right, that example. And there are some analogies, though, from that technology. And it's even more complicated than that with an individual hospital's cost to charge ratios, differences in Medicare reimbursement. But I think at the broader level, at least our institution would be enthusiastic in incorporating a technology that's going to be game-changing for patients' outcomes. And then we have to work around the costs and work our way back to it, rather than say, we just can't do this because it's not going to be profitable. It is a cost-effective procedure. We'll show more data at this meeting, in fact, tomorrow and Saturday with regard to that. But with assuming estimated prices of the procedure and estimates with regard to Medicare reimbursement that we might anticipate. But to your point, yes, at least as an institution, we're starting to think about how we can, when there's a greater emphasis in general on quality for reimbursement, and when third-party payers are, whether it's cardiac transplantation or LVADs or general care, when Aetna's and Blue Cross's and UnitedHealthcare's of the world are looking at centers based on their quality, that if you can achieve better outcomes, in this instance, through blood pressure, then yes, that makes you a more attractive institution to offer this therapy. As I shared earlier in a passing comment in discussions that sponsors of these programs have had with third-party payers, they know already that hypertension is a huge marker for them of risk and cost. It's a huge cost center. It's associated with substantial comorbidities and downstream costs. In the healthcare utilities world, stroke, as you can imagine, and heart failure are huge cost centers for these programs as well. And if you can avoid that, then it's an advantage to them. So yes. Sorry to chime over. Just four points of, and all of David's points are obviously super informative and well-taken, as always. Four points of caution is, one, unlike something like Shockwave and even TAVR, this is a titanic in terms of what it represents. 40% of the population has hypertension, and these solo trials are showing that you can treat patients on no meds. So think about what that means if it's a marginal loss. It's a very different scale of what the impact is at individual hospitals and the national healthcare system's standpoint. The second point of caution is regarding the issues that relate to the shared risk modeling that was brought up. That's hyperlocal. If you know one shared risk agreement, you know one shared risk agreement for a health system and their payer. So it's not so easy to scale that in a really obvious way with how the healthcare landscape works right now in the US. And then the third point of caution I have is, when we're talking about cost-effectiveness, frequently when publications are made about cost-effectiveness, they're from a societal standpoint, and they may well factor in things like readmissions and other things that really, loss of work and all these things. But keep in mind what hospitals are incentivized towards right now is a very local decision-making on the cost and profits that are coming in or contribution margins, obviously euphemism, that's coming in at their own local level, which may sort out a little differently and may be influencing care differently. That's an area of interest in our research group right now that we're looking into with a few different procedures to see if that defers. So there are kind of several points that are actually fairly complex, but the biggest thing that, in order to model all this out, we need is kind of transparency on what the inputs are. Once you get the inputs, then we can start going to work like David was mentioning on some of this. I can just, directly to the question of ACOs and population health. We've been very careful about not making those arguments with our group. When we talk about hypertension management in the system level, we talk about how our primary should be approaching high blood pressure. We talk about that all the time and improving control rates. Our ACOs are tens of thousands of patients in size, right? And we're taking care of hundreds of patients in our resistant hypertension clinic. It's hard to move the needle. Most of those patients actually are still over 140, over 90, even though we've lowered their blood pressure maybe 40 millimeters. So it's hard to move the needle with a technology that you're maybe in a great, I mean, maybe you'll, I mean, you'd be a great center that you did 50 cases in a year, right? And so it's just hard to move the needle in a population health basis. Now, when you start talking about how am I gonna compete in this marketplace to my hospital? How am I gonna get somebody to come here rather than to a competing hospital system? Having this technology available becomes, I think, something that's very valuable to the hospital. And we've kind of tried to talk a little bit more about that than, oh, we're gonna improve the overall control rates of your ACO population. I think that's hard to do without really going to the grassroots level and changing what frontline health workers are doing in terms of what they're doing in their office and getting more people into the office. I mean, that's the biggest problem is, a lot of these patients aren't even seen, right? They're in the ACO of our hospital system and they haven't even been seen by the hospital, so. I just wanted to put in a plug for the VA healthcare system. I don't know how many people are affiliated or work with the VA, but about half of my work is at the VA. Yeah, and we've already had, started having discussions with our administrative staff about it. Because the VA, I mean, they're worried about cost as well, but the providers are not worried about productivity or RVUs. Everything is based on quality metrics at the VA. And we get these monthly sale reports and hypertension and cardiovascular risk and disease is always on the top of that list. So they're already buying in to forming sort of hypertension groups and any technology that could be an adjunct to helping with hypertension would be something that's very easy to roll out at the VA sort of nationally. I couldn't agree more, yeah. Very different incentives. Much more positive for them. Well, so, you know, I had an interesting conversation at the break with somebody about what happens if this eventually moves, and it may, into the outpatient setting, specifically into ASCs or OBLs, right? I mean, you can imagine that happening. So, and there's probably less scrutiny there. And I, you know, I was using the example of, in the state of Michigan where I work, there's a requirement if you're doing PCI at a site without surgery, and if you're doing PCI in an ASC that you participate in, you know, either one of the state or the national quality registry. So, yeah, I mean, it'd be great if, as this technology diffuses, if there was some mandate, I don't know how realistic that is, but I do think there's a need for a registry. I think we need to see what this looks like in the real world. And we, you know, you've got the global simplicity registry, but what do we have in the US? Yeah, and I think, well, I mean, part of the first early stage would be the post-market studies that are going on in a firm, and GPS would be, help fill that gap for a while. But what's the sustainable pathway? I agree, it's gonna need a module built on some NCDR or some other. And is that registry better as a procedure registry or a disease-based registry is the next issue? I mean, you know. Yeah, well, that's our other challenge. I think most of the quality registries that exist that we participate in are all procedure-based, right? There are few exceptions to that. They're not disease-based registry. You could argue that because of ease and convenience, but it's maybe, it may not be the thing that's in the best interest of actually population health, right? Trying to manage the disease, procedure being one component, but there's obviously tremendous complexity in disease-based registries. All right, thanks, everybody. I think we're gonna conclude here at 5.30. Thank you so much for the discussion. To the panelists, thank you so much for being here. Thank you, everybody. Thank you.

hypertension

renal denervation

multidisciplinary approach

interventional cardiologists

long-term patient care

social media

cost-effectiveness

underserved populations