The evidence behind renal denervation has been rigorously produced in just a few minutes. I'm going to try to talk about this in five minutes, and hopefully that will give you a one-minute message when you're speaking to your patients or referring. So what we're talking about first is ultrasound renal denervation. I know we haven't gotten into the technical aspects of these procedures yet, but that will be coming. But the basic idea here is that this is a catheter, a simple balloon catheter, similar to what we use in other circulations. But it does have an ultrasound built into it that enables for heating, and then it has a special proprietary system that enables for endoluminal cooling—that's the water cooling to make sure there's not vessel injury. The heat then reaches the periadventrial nerves and ablating them. And basically, it's three seven-second sonications per renal artery on each side gets the job done. So from a clinical evidence standpoint, which is the most important thing, getting beyond the technical aspects, how has this been formed for ultrasound-based renal denervation? Well, I'm going to draw your attention to the middle, which is going to be what we're talking about here, which is the prospectively powered sham randomized control trials. And there's been three of them. They are the radiance hypertension solo and trio trials. Those were essentially—they're called pilot studies, but they're really seminal evidence. I hate to even call them that. The solo trial was really based on taking patients who are not on medicine. So this is trying to justify the efficacy of the device, the safety of the device, in patients who are not being treated otherwise. Imagine the population of patients we're talking about there. The trio trial is for truly resistant hypertension patients, which we just heard a lot about. These are on a standardized three-drug regimen that these patients are going to be on. In both cases, these are sham-controlled trials, so kind of the highest level of evidence that you can produce for a procedure. Finally, the radiance two-pivotal study, which just has a little greater N than the solo study, but has essentially the same protocol in place as the solo study. And as I mentioned, the hypertension trials here, the solo study, you're looking for daytime ambulatory blood pressures greater than 135 over 85, but not horribly, horribly uncontrolled hypertension of 170 over 105. And the reason for that is because you are going to have to have these patients not taking drugs for a little while, while you're performing the denervation on them and then following them forward. And similarly, in the sham arm, they're also going to do that, so they have to be equipoised for that. For the trio study, you have uncontrolled hypertension on three drugs. So there's details on the right, but the bottom line is that that's the structure. And when we follow these patients forward, what do we learn? So we first learn that in solo, you have drops in blood pressure at two months, and these are ambulatory BPMs. And you can see, I'm sorry, what's happening here, eight millimeters mercury in RDN versus two in sham. And I'm talking about the intention to treat, but you can see the PER protocol is even more impressive. Similarly, in trio, you also have eight versus three millimeter drops in the intention to treat arms. So you are getting reductions compared to sham and with a rigorous form of blood pressure measurement. There's ambulatory blood pressure measurement, not just office-based blood pressures. The other thing to bring up, and I'm just going to skip to it, is what Dr. Block mentioned. If you look at the trio arm, naturally, there is some medical management going on in follow-up in these patients. And I'll just point you to the fact that in the sham arm, there is a lot more aldosterone antagonists being used and added on in those patients over follow-up. So despite that, the trial was still positive, and despite what he just mentioned about the potential efficacy of that therapy. This is just looking in the ambulatory blood pressures at how patients look over the course of a day. So this is in solo now. So this, again, the patients who are not on meds, you can see that at two months, you've got a drop. And at six months, look, that drop is even more. Now there's some medical management going on there. In the sham, there's almost no change at two months. And as medical management kicks in, there's a little bit more drop over time. And there's also some aggression to mean issues going on here, I'm sure, as well. In trio, which is the uncontrolled hypertensives, at two months and six months, you've got a quick drop. Now remember, these are more aggressively managed patients from the beginning. They're on a lot of meds. And in sham, once again, you don't see the same drop, especially early, that you see with ultrasound renal denervation. And then the next question that comes up is, what about durability? Well, following patients out to two years in solo, it looks like it is persistent, the benefits in systolic and diastolic blood pressure, to see clearly here. You'll ask about safety. And the positive thing here is this therapy didn't seem to be causing a lot of problems in terms of the typical interventional vascular complications in the leg or in the renal arteries, etc. And also not down the line in terms of causing problems with renal stenosis late, etc. And finally, radiance hypertension, which was technically a pivotal study but was modeled after solo, showed very similar results. But the pooled analysis, which was mentioned once, backs all of this up. And I'll just show you what happens in the pooled analysis. You can see that when you're taking all the patients, 500 patients that are randomized across the two therapies over six months, we do have those same drops being demonstrated. So in summary for your patients, I'll leave you with kind of three major points that you can take from this. One is that the therapy has been tested in the most rigorous methodologies possible, and it is positive. It's efficacious. Two is that it appears durable out to a couple of years for sure. And three, we don't seem to have any real major safety signals here. One fourth point, how much is it worth to you? Looks like it's worth about a drug on average, but we're going to find out whether maybe it's worth a little bit more in some patients than others over time with further research. Thank you.

ultrasound renal denervation

hypertension treatment

clinical trials

balloon catheter

periadventrial nerves