Chapters Transcript Video Renal Denervation I'm going to speak on Ronald Innovation hype or hope so. I don't have any financial disclosures. This talk is going to discuss investigational devices and procedures that aren't currently FDA approved. So hypertension control is poor as most of you know, hypertension is very common. It affects about one in two U. S. Adults. Blood pressure control is decreasing among adults who are taking medicines. It's the leading cause of heart attack, stroke and death. Noncompliance is very common at one year. It's 50%. And medication and lifestyle changes aren't always enough. So what that leads to is about 80% of people with hypertension do not have their blood pressure under adequate control. So what does that mean? That means they're at risk for heart disease stroke. Heart failure. And so here's from a very large study looking at 350,000 patients showing in the orange. If reduce blood pressure by five millimeters in the black or dark brown. It's if you reduce it by 10 millimeters of mercury, you can reduce events, cardiovascular events by 10%. For just a five millimeter reduction, 20% for a 10 millimeter reduction. So that little bit of blood pressure reduction goes a very long way in terms of preventing any type of cardiovascular disease stroke. Heart fire. Um cardiovascular death. So people have had this concept of renal innovation. This has been around for probably at least 15 plus years. And as some of you may know, it's really kind of the brain and the nervous system that affect the blood pressure. It's not the heart. People sometimes get confused on that. And so the brain has nervous system signals that it sends out via the pathway that go to the kidneys and the kidneys in return that in the different pathway. And what those sympathetic signals do is cause vessel constriction within the kidney artery. But they also caused increased sympathetic tone throughout the body. So the concept was, if we do renal, the innovation that maybe we can inhibit the sympathetic nerve activity. So people, most cardiologists are trying to look for an interventional, fix the things. So people postulated maybe we can make advice to do that so we can deliver energy to the renal nerves to help control blood pressure, there's no permanent implant left behind. It's do the procedure. Everything comes out. So there's many types of Ronald innovation. To the furthest along is the record paradise ultrasound ablation. So it uses ultrasound delivers ultrasound energy to the renal arteries affecting the nervous system. And then what's furthest along is the medtronic spiral simplicity ablation system. And so that has the most data, it's very close to FDA approval. So, I'm going to focus the rest of the talk just on that system. So, for those of you who may have followed this along along, on the sidelines for about the past 15 years. The first few studies came out in animals. First few studies in man, this looks like a home run. This would drop your blood pressure about 2020. People said this is gonna be great. So a lot of hype sort of the interventional procedural snake oil if you will. That this is gonna be great. So people did the first few studies you see simplicity want simplicity to which were just sort of a proof of concept. Could we get this done? And blood pressure reductions were 20-30 mm. People, this is this is great, everybody very excited. So the company did his due diligence and they did simplicity three. So this was a shame controlled study using an older system. And they found out that Ronald Innovation did not make a difference at all. So a lot of people's hearts sank after that like, well, wait, wait, what? You know what happened, what went wrong? So then people went back and they looked very carefully at what's happening. And so what they found was the renal nerves are typically closer to the looming in the artist, more distal. So the previous procedures had tried to d innovate more proximal what you really need to do with more distal and into the branches. So the strategy changed and the device changed. So the device that's still under investigation. But furthest along is the medtronic simplicity spiral system. And what this uses a catheter. It's delivered via six french sheath. It's a flexible spiral corkscrew type of catheter that you deliver your place in the reality deliver energy. There's no permanent implant left behind. Um takes less than an hour to get this done In the beauty of the same relative to medicines. It doesn't rely on patient adherence or compliance. You do the procedure and it's working 24/7. So this type of procedure uses a skill set that interventional cardiologists have have already mastered. So now with this new strategy, new catheter company said fine, let's let's do a new series of trials. So I'm just going to focus on three of those the spiral hypertension off med on meds and in the global simplicity registry several the others are still ongoing. So I'm not going to go through the entirety of this slide. But this was a study one of the first ones with this new catheter new strategy called off med. So to be in the study you had to have naive hypertension not being treated or you had to be willing to go off your medications and your blood pressure had to be more than 1 50 less than 1 80. And you got enrolled and you got enrolled randomized to either treatment with renal innovation or a sham procedure. So patients didn't know what they were getting. Other doctors didn't know what they were getting. Um So it's about the best design that you can do and the primary endpoint was three month blood pressure And what you can see if we just focus on office systolic blood pressure. There's a reduction of about 9 mm In systolic blood pressure and it's not it's about six over control. Remember we talked about reducing cardiac events. All you needed was five. So then they said fine, that seems to work. Let's now do on med. So now these patients could be on medications. The entry criteria had to be blood pressure 1 50 or more less than 1 80 they're either on 12 or three meds for at least six weeks. So sort of stable baseline average patients that we see again randomized to either the procedure or a sham control in their in point Was out to three years to see what happened. So here's the results of that and we're gonna focus on office systolic blood pressure. What we see at three years now, the blood pressure is reduced by 20, which was still eight more than the control group. Here's what's the more interesting thing is this taking that same patient population and looking at their 24 hour blood pressures. But patients who got Reynold innovation and looking at 24 hour blood pressure, 80% of them had a blood pressure less than 1 40 compared to the control, which is 44%. So what this does. It leverages the fact that it doesn't require any patient compliance with the medications. Its procedures done. It works. It works 24 7. So the majority of patients had good blood pressure control. So the last time I want to talk about is the registry. So this was the 3000 patient data there now. Up to 4000 patients. But this is 210 sites. 43 countries. And this looks at three years all comers and whether you were um not on medication, whether you're on 123 medications and looked at your blood pressure at varying points six months, one year, two year, three year, you can see it every single point blood pressure reduced. So this wasn't necessarily a comparison trial. It's just showing you that this is effective for lowering blood pressure. So you can see out at three years office BP lowered about 17 mm. And when you look at the subgroups, you got a benefit and a whole variety of patients. You got a benefit in the resistant hypertension, the isolated systolic hypertension, the elderly, a fib diabetes and the people with renal insufficiency. So every group that they looked at, God to benefit the group that got the biggest benefit was the resistant hypertension group. So based on that S. C. I. In the National Kidney Foundation put together a consensus statement on renal d. Innovation experts sitting down saying, okay, where does this fit in our treatment of hypertension? And first off they admit there's sort of a lack of progress in blood pressure control with kind of use medicines about as much as we're gonna be able to use them patients are taking about as much as we're gonna be taking them we're not making a lot of progress on that Hypertension still remains a very leading cause of death and disability through heart disease and stroke, cardiovascular and renal risk and complications can be significantly reduced even with only modest reductions in blood pressure of only five or 10 can drop that cardiovascular event rate down about 10%. So what they propose is multidisciplinary hypertension clinics might play a role in the treatment landscape with a discussion of patients of renal d innovation as a possible treatment. And they conclude by saying the efficacy arenal de innovation for treatment of uncontrolled high partition has been consistently demonstrated and shame controlled randomized trials, both in the presence and absence of medications. So how does that look when you're with patients? So it's going to be a shared decision patients on one hand, they're looking at blood pressure medicines not wanting to take them concern of side effects or actual side effects. Whether they see blood pressure is a risk or not a risk. And just their own personal experience from high blood pressure physicians are gonna see this and say, oh your blood pressure is way too high. You need a good treatment for that. How many medications are you on? Is it well controlled and you come to this sort of shared decision making and then you have a patient physician decision. So remember we started this with a lot of renal innovation initially was a lot of hype. And then when you when you did the first randomized trial no benefit. I think now after subsequent trials we can now say renal de innovation provides a lot of hope. What we can say is that lower systolic blood pressure about 19 mm at three years. It complicates complements medicines and lifestyle changes. It's gonna serve as an adjunct. It's not going to replace medicines, it's not gonna cure hypertension. It just improves hypertension. So other people can be on the same number of medicines with better blood pressure control or fewer medicines with similar blood pressure control. The beauty of the whole thing. It doesn't rely on any patient compliance. You do the procedure, it's done. It works. It provides that control 24/7 And if you look at some of the modeling, If you take the results of their trials and you do a model, they predict that you're going to lower mace rates or major adverse cardiovascular events about 26%. So that's that's really the reason we're treating blood pressures to lower our event rate. So their prediction is that it will. So, if I had a crystal ball and predicting how this is gonna look. My prediction is 2023 medtronic hopes to have approval for their device. Others will follow. And what will happen is patients, I don't know what the FDA is gonna make the approval for the indication. But I suspect it's going to be hypertension of many flavors, including naive, probably with medications and possibly some level of control. And in physicians and patients have that discussion. It's not gonna be sort of a fly by night operation. I think you're gonna need to have a center and a system set up that you're evaluating people for secondary cause of hypertension. You're looking carefully at their blood pressure, having a full discussion of all the treatment options, risk and benefits and if that seems appropriate, then go ahead and proceeding with that. Great. Thank you very much. Published December 7, 2022 Created by Related Presenters Kerry Prewitt, M.D. CardiologyInternal Medicine View full profile
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