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CME / ABIM MOC

European Society of Cardiology’s Position on Renal Denervation: The Time Is Upon Us

  • Authors: Thomas F. Lüscher, MD, FRCP; Roland E. Schmieder, MD, FACC; Sofie Brouwers, MD, PhD
  • CME / ABIM MOC Released: 9/27/2022
  • Valid for credit through: 9/27/2023
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  • Credits Available

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    ABIM Diplomates - maximum of 0.50 ABIM MOC points

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Target Audience and Goal Statement

This activity is intended for primary care physicians, general cardiologists, interventional cardiologists, nephrologists, and healthcare practitioners (HCPs) throughout the world who care for patients who have elevated blood pressure.

The goal of this activity is that learners will be better able to interpret renal denervation results and its potential clinical utility.

Upon completion of this activity, participants will:

  • Have increased knowledge regarding the
    • Consensus statement on renal denervation for managing hypertension
    • Identification of patients who may benefit from renal denervation


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Moderator

  • Thomas F. Lüscher, MD, FRCP

    Chairman of Research, Education & Development
    Consultant of Cardiology
    Royal Brompton & Harefield Hospital Trust and Imperial College in London
    Director of the Center for Molecular Cardiology
    University of Zurich (Campus Schlieren)
    Zürich, Switzerland

    Disclosures

    Thomas F. Luescher, MD, FRCP, has the following relevant financial relationships:
    Consultant or advisor for: Daiichi Sankyo; Pfizer
    Research funding from: Abbott; Amgen; AstraZeneca; Novartis; Vifor

Faculty

  • Roland E. Schmieder, MD, FACC

    Professor of Internal Medicine, Nephrology, and Hypertension
    Head of Clinical Research Center of Hypertension and Vascular Medicine
    Department of Nephrology and Hypertension
    University Hospital Erlangen
    Erlangen, Germany

    Disclosures

    Roland E. Schmieder, MD, FACC, has the following relevant financial relationships:
    Consultant or advisor for: Ablative Solutions; Medtronic; Recor
    Speaker or member of speakers bureau for: Ablative Solutions; Medtronic; Recor
    Research funding from: Ablative Solutions; Medtronic; Recor
    Contracted researcher for: Ablative Solutions; Medtronic; Recor

  • Sofie Brouwers, MD, PhD

    Cardiologist and co-director of the Hypertension and Lipid Clinic
    Cardiovascular Center
    OLV Hospital
    Aalst, Belgium

    Disclosures

    Sophie Brouwers, MD, PhD, has no relevant financial relationships.

Editor

  • George Boutsalis, PhD

    Senior Director, Content Development, Medscape, LLC

    Disclosures

    George Boutsalis, PhD, has no relevant financial relationships.

  • Frederick Stange, DO

    Scientific Content Manager, Medscape, LLC

    Disclosures

    Frederick Stange, DO, has no relevant financial relationships.

Compliance Reviewer

  • Stephanie Corder, ND, RN, CHCP

    Associate Director, Accreditation and Compliance, Medscape, LLC

    Disclosures

    Stephanie Corder, ND, RN, CHCP, has no relevant financial relationships.

Peer Reviewer

This activity has been peer reviewed and the reviewer has disclosed no relevant financial relationships.


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CME / ABIM MOC

European Society of Cardiology’s Position on Renal Denervation: The Time Is Upon Us

Authors: Thomas F. Lüscher, MD, FRCP; Roland E. Schmieder, MD, FACC; Sofie Brouwers, MD, PhDFaculty and Disclosures

CME / ABIM MOC Released: 9/27/2022

Valid for credit through: 9/27/2023

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Activity Transcript

Thomas F. Lüscher, MD, FRCP: Hello, I'm Tom Lüscher from London and Zurich, and I'm delighted to moderate a session on the ESC's Position on Renal Denervation: The Time is Upon Us

So, I'm delighted to welcome my partners here, Roland Schmieder from Erlangen, a nephrologist interested, of course, very heavily in high blood pressure. And Sofie Brouwers from Aalst in Belgium, who is a cardiologist and working in a cardiology department. They both are real experts on the field, and I think we're really set to discuss this topic further. And the reason why we do this now is that we just published a consensus paper on this very topic, because we felt that now we have the appropriate evidence to reconsider everything, and to provide recommendations for patients and physicians alike how to use such a technology, and in what situation. So Sofie, why don't you enlighten us a little bit on the document

Sofie Brouwers, MD, PhD: So yesterday we presented at European Society of Cardiology (ESC) in Barcelona 2022, the Renal Denervation in the Management of Hypertension in Adults Clinical Consensus Statement. It was a collaboration of the ESC Council on Hypertension and the European Association of Cardiovascular Interventions. And together, we made this Clinical Consensus Statement to set the stage for where to go with renal denervation from now on.

Dr Lüscher: All right. I think everybody that did anything in the field was part of it, but of course it's a European document indeed and, as we hear, similar attempts are on the way in the US. And obviously, it will be crucial also to hear what the Food and Drug Administration will decide shortly about the use of this technology. So Roland, why don't you enlighten us a little bit more on the content of what we produced and some really important core messages of the document?

Roland Schmieder, MD, FACC: In the document -- I think it was necessary to develop that. We had these large-scale studies with certain inclusion criteria. They are good to create science to know now that renal denervation works, but then the question was how to transfer that into clinical practice. And I think this was the greatest task of the document and of the consensus paper to come up with one recommendation based on evidence, based on the sham-controlled trials, but also based on worldwide registries that reflect real-world situations.

Dr Lüscher:  Right, so we really have a body of evidence that's quite considerable.

Dr Schmieder: Of course, the heavily debated issue was who are the patients which needs to be treated, which should be treated, which might be treated, or which may be willing to undergo this procedure? And they have heavily debated on that, and I'm glad to share with you the wording that has been presented yesterday at the European Society of Cardiology and the others according to the available evidence, such as outlined that this expert group suggest considering renal denervation in patients with uncontrolled hypertension despite treatment with three and more drugs in appropriate doses, including a diuretic, confirmed by an out-of-office measurement, thereby getting rid of white coat hypertension, preferably ambulatory blood pressure measurements, and an eGFR above 40 mL/minute/1.73 m2. And it further says, of course, we need to exclude secondary causes of hypertension, so it focuses on primary hypertension. That's now a clear, I think, precision with respect to untreated resistant hypertensive patients.

Dr Lüscher: So Sofie, what would we do to exclude secondary hypertension?

Dr Brouwers: So I think it's important whenever patients with hypertension are seen and it gets a little bit more complicated, they're most likely to be referred to a hypertension clinic. And there, the first step is to indeed suggest that the out-of-office blood pressure measurement is also elevated, so we really have the diagnosis of hypertension. And then we obviously need to look for secondary causes of hypertension. One of the most common one, primary hyperaldosteronism, and the whole list behind it. Once these secondary causes have been excluded, we can proceed by treating the so-called primary hypertension in these patients.

Dr Lüscher: So what examinations would you suggest to do?

Dr Brouwers: So we start with the laboratory test, with the urinary test, with the echography of the renal arteries, and then, depending on the situation, to go to CT or MR for visualization of the surrenals.

Dr Lüscher: Okay. So we have excluded secondary hypertension. Now, you mentioned the word resistant hypertension. What is that, precisely?

Dr Schmieder: Well, the definition actually is reflected in this statement, resistant hypertension. You are on three drugs, preferentially a single-pill combination, and you are not controlled. Not controlled means office above 140/90 and confirmed by out-of-office blood pressure measurements that you are indeed hypertensive during daily life conditions.

Dr Lüscher: And these 3 drugs, it doesn't matter which ones?

Dr Schmieder: No, and I think it's very nice that you see that where the renal denervation fits in into the therapeutic regimen for hypertensive patients. And when you see on this slide on the right side, the classical core medication up-titration, when you see an angiotensin-converting enzyme (ACE) [inhibitor] or angiotensin-II receptor blocker (ARB), a calcium channel blocker (CCB), or diuretic at the beginning, then all three together. And the reason why we have chosen these three to be first and second step is we have solid evidence that they improve the prognosis, meaning less cardiovascular events, less cardiovascular morbidity. This has been shown only for these three agents. Beta blockers, data is a little bit shaky, I put them aside.

And then we come to the next level and then it's called resistance hypertension. So what are we doing there? The guidance with respect to endpoints, no chance. There is no study for spironolactone, for alpha blockers, not yet for renal denervation. And there, we say well, this is the field where renal denervation may come in, in considering this not as a competition, it's important, it is an additive choice because the old single-pill combinations need still to be taken, but as an alternative to spironolactone, and other drugs. So this is more of the position at the moment.

Dr Lüscher: Right, so at this point in time, they also have to involve the patient, because obviously it's a different thing taking a drug or to undergo a procedure. So the important question is what do you tell the patient about the safety and the efficacy of the procedure?

Dr Brouwers: Yes. It's important to inform the patients because they usually are not aware that this technique exists. It's becoming more well-known, but very few patients know about it. We explain to them that efficacy and the safety have been clearly shown, that there's no discussion point left on that level, so that this intervention is safe and efficacious. It is an intervention, so obviously compared to just taking single-pill combination these days, there's a next level, but we explain to them that there's just the usual side effects that we see in any intervention going through the femoral artery. So there's nothing more linked to it.

Dr Lüscher: So basically is a femoral approach.

Dr Brouwers: Femoral approach.

Dr Lüscher: So bleeding at the groin is probably the most common complication. What about damaging the renal artery, dissection, and so forth?

Dr Brouwers: We don't have any signs from all the trials that have been done that we have an increase in damaging of the renal artery in the short term or in the long term, and there is the progression too. For example, renal artery stenosis is absolutely not higher than just a normal process over the lifetime. So I think we have an excellent safety profile for this intervention.

Dr Schmieder: I want to stress that I think it's important to know that this evidence has been obtained in 5000 patients treated in randomized controlled trials, treated on a worldwide basis, followed up for 3, 4 years now. Even the first ones have just been also followed for 8, 9 years now in Australia, where the first renal denervation has been conducted. So we have ideally, a solid base with respect to safety, and that's really to stress first to the patient it's a safe procedure, with exception, of course, the local complications by puncturing the femoral artery.

Dr Lüscher: Right. But today, we do ultrasound puncture, we have closure devices, so this is really getting less and less. The next question, of course, is what can we expect from this intervention? What decrease in blood pressure in this very population that you outlined here? Yeah, Sofie, why don't you mention?

Dr Brouwers: I think first of all, I just want to stress one more time that we do not tell the patients or we do not expect them to stop medication once they had the renal denervation.

Dr Lüscher: Sure. No cure.

Dr Brouwers: No, it's no cure. It's on top of the treatment because they are not reaching the treatment targets, so we propose this these treatment on top because they are resistant hypertensive patients. And then we see actually the same drop in blood pressure on office, and on ambulatory BP measurement, and home blood pressure measurements. That come with well-dosed pharmacologic agents.

Dr  Lüscher: So this is about what? In terms of millimeter of mercury?

Dr Brouwers: On office blood pressure measurements, we see sometimes a bigger decrease, but that can be obviously more variable. That is well known.

Dr Lüscher: So on average, it's about 10.

Dr Brouwers: But on average, the out-of-office measurements, yes, that is 10 mm Hg.

Dr Lüscher: Do you want a 24-hour blood pressure measurement before and after or do you just rely on office blood pressures?

Dr Brouwers: No, it needs to be proven that the patient is hypertensive, and I think we cannot do this with only out-of-office blood pressure measurements. Even if we use the visit-to-visit variability. I think we need some kind of out-of-office measurement. If in countries it's difficult to get an ambulatory blood pressure measurement, I think we can work with a well-measured home blood pressure measurement, but I think you cannot rely on a single in-office measurement.

Dr Lüscher: Right, because we want to exclude, of course, white coat hypertension.

Dr Brouwers: Yeah, we do not want to treat a normotensive or a white coat hypertensive patient.

Dr Lüscher: Yes.

Dr Schmieder: I would like to mention 10 mm Hg decrease sounds not so much. Let's say you have a patient of 165 and you say to him, "Well, on average, we have 10 less." And we say to him, "Well, usually have 10 less with a 75% probability. Other words, three out of four, we have this kind of response or larger," but we have also tell the patient that 10 mm Hg reduction office blood pressure means a reduction of stroke by 28%, it means a reduction, in terms of development of congestive heart failure, 27%. So that's quite huge. And overall, a reduction in MACE is something around 20%, so it's really a substantial reduction. Also, we have not achieved the ideal BP goal, which is now 130/80, but nevertheless, 10 mm Hg less, it really translates to an improvement in the prognosis. And I think this needs to be stressed also.

Dr Lüscher: The next question is how durable is it? Of course, we know from transplant patients where we measure heart rate, we can easily see whether there's reinnervation. And in some, there is, not generally so, but in some, there is. So what about that?

Dr Brouwers: There is evidence like the durability of the effect has now been published up to 36 months. So I think the durable effect and the data for longer term will come out. About the regrowth, there is evidence of regrowth of the nerves, but they are not functional. So it's definitely not a functional regrow of the nerves, so this then tells us this blood pressure stays decreased. The first drop we see about 8 to 12 weeks after the intervention, but there are now meaningful drops in blood pressure up to 36 months, as I just mentioned, which is important to say that in the long run, the blood pressure continues to be low or even get lower. So the durability is quite impressive.

Dr Lüscher: Now, the out-of-the-box question is we have a trial where they actually treated patients without any drugs. And I had patients that said that "I don't want to take any drugs. I would like such a procedure." So what's the position there at the moment?

Dr Schmieder: We discussed it in the consensus paper and at the end, we cannot recommend that. It is just because we have, let's say, limited experience up to 3 or in some, maybe 4, 5 years. So make a general recommendation based on that is not valid for clinical practice. It is important for the authorities because it's like you have a phase 1 study with a new drug, you just do it in patients without any other interventional drug-lowering systems. And that's the reason why the authorities wanted, actually they forced us to run a trial without any medication, and the results are very clear.

Dr Lüscher: Very clear.

Dr Schmieder: Very clear. It's a great and significant reduction with the highest technology applied to measuring blood pressure.

Dr Lüscher: This particular study, I find very, very interesting, and I would like to speculate a bit because high blood pressure is a slowly developing disease. And of course, there is a vicious cycle as we develop structural changes and then we get even higher up. And of course, we didn't mention that initially, but in patients with systolic hypertension that primarily are related to this remodeling process rather than the initial systolic, diastolic form of hypertension, they're not so suitable for this procedure. So this would actually tell me that in the earlier phase, it might be actually better than when we wait until structural changes have occurred?

Dr Schmieder: I would agree from there's a big rationale for this hypothesis, and I can understand that maybe some patients just don't prefer to have a drug taken life-long because this intervention, once it's done, it's done. You can forget about that disease. And this is very attractive for patients to make the procedure, even if they have to stay 1 day in the hospital, and let's say to slow down the progressive increase in blood pressure which we have in our Western civilization.

Dr Lüscher: Yes. Because there is also a trial by Steve Julie that actually focused on that, whether we can prevent hypertension by very early treatment. What do you think, Sofie?

Dr Brouwers: I just wanted to add something else, that I think it's important to take into account the opinion of the patient, because we all know that resistant hypertension, as we call it, is also very often the patient who is not drug adherent. Up to almost 50% of the patients are just not taking the medication because they don't want it, they don't like it, they don't want to do it on the long run. It's also a variable process. And I think here it's very important we cannot force them to take medication if they don't want to because they're not going to do it. They're just not going to take the medication, and then they might come to us and be like, "I want only this intervention and then I'm all set." So, as we discussed in the consensus paper, we cannot advise that as first on therapy because we don't have enough evidence, but I think it is very important to take the patient consideration into account in this whole decision process.

Dr Lüscher: Well, of course, as somebody important once said that “drugs only work if they are taken” and that is quite clear. And compliance is a major issue in hypertension, and we know the more pills you take, the less likely you actually take them all. And once you have 3, and then you have to add 4, or 5, I mean that becomes more and more difficult, and therefore it's very interesting to consider a renal ablation that's a one-shot treatment.

Dr Brouwers: Always common.

Dr Lüscher: Yes.

Dr  Schmieder: This is a little bit reflected in the second group in our consensus paper of patients that maybe considered for renal denervation. This is so-called drug intolerance. Now, if you have a drug intolerance, of course there are these true intolerances related to the chemical compound the patient have to take every day, but there are these patients who have, let's say, not so specific symptoms, but they are so strong in the patient's perspective that they don't take the drug, they just forget it. They don't want to get rid of their disease and don't think about it.

So these are the nonadherence issues in the major part of patients, and they have always had patients who are nonadherent or intolerant to multiple antihypertensive drugs, particular first-line agents, the 3 ones we mentioned, and spironolactone in particular, may also be candidates for renal denervation. And these patients may be on a fewer than 3 drugs, it's not required that they have 3 drugs, could be also just 2 or even 1 drug, at the time of their selection for renal denervation due to their poor drug intolerance or non-adherence, I would say. And Sofie already mentioned it's important then to have this shared decision-making process.

Dr Lüscher: Right. And of course, some patients, when you really go up with dosage, like with the calcium blocker, then they have swollen ankles, and they hate that

Dr Schmieder: They tolerate in winter, but then it comes summer and then they stop the medication, blood pressure goes up. So it's a solution for those patients.

Dr Lüscher: Absolutely. Now, the other question, we just had a trial presented by Val Fuster that you should have a polypill. So should we use a polypill also in hypertension to make people even more compliant? Because even if you do renal ablation but they don't take the drugs, then you end up in the same situation like before. What do you think, Sofie, about this trial?

Dr Brouwers: I was just going to answer on the polypill question because I think it's important to start actually the whole process also by explaining to the patient why we are so focused on this blood pressure, why we think hypertension is important, and what on the long run are the risks the patient is taking. So that's why we obviously always have to also stress the importance of lifestyle measurement, and then we try to always prescribe a single pill combination of mostly the 3 drugs, and then propose a renal denervation. And the patient is more likely on the long term to stay to the lifestyle measures more or less and to the single pill combination if they are informed why this is important for their health, especially on the long term. While with renal denervation, obviously once it's done, there's no adherence to that treatment anymore.

Dr Lüscher: In my experience, particularly if you tell patients that blood pressure is associated with dementia, then they start to think probably I should take this really because even cardiologists say rather have an infarction than a stroke or dementia. Now, of course, the next question is we don't have outcomes data. We all know very well for calcium antagonist in particular, but also ACE inhibitors, angiotensin blockers, we have very solid data, and also now with spironolactone. So what should we do there? What is in the pipeline and what would be the right trial to really prove such an effect?

Dr Schmieder: There has been a heavily discussion on that issue and, of course, we hear very often the point we need an outcome trial, but the point is how to run such an outcome trial. Think about you make a sham procedure and then the patient should stay not knowing whether it has been real, or they have been in the sham control group, in other words, have they been treated with renal denervation or not. You can do that for 2 months, 3 months, even maybe 6 months, but then we see or their GP, that the patient is not controlled. The physician adds another drug, another drug, another drug. So you would have narrowing even an overlap to the same point. And if you analyze available data at 1 year, 2 years, 3 years, what you find usually is less medication in the renal denervation group, significantly less, but more in the sham group. So you have a very narrow or even no difference in blood pressure, and then you cannot run an outcome trial.

Dr Lüscher: You can only conclude that they'll reach the same result with less drugs.

Dr Schmieder: Maybe, or the point then came up to say well, with renal denervation, we lower the sympathetic activity in the whole body so we will have effects beyond the blood pressure lowering effect.

Dr Lüscher: Like arrhythmias maybe.

Dr Schmieder: Right, atrial fibrillation is the best example. And the most advanced. The results we have in that field, even prospective randomized trials, the AF ablation plus renal denervation, those together are superior in preventing recurrence of atrial fibrillation in hypertensive patients. So we have, of course, better control of blood pressure, but also we have decrease in the sympathetic activity to the heart. So this is a question, so it might be, but what I want to say also, there have been some calculations and it came up with 20-25,000 people with uncertainty whether they can be followed up for 3 years or 4 years, so I would say it's not feasible. That's the point, it's not feasible.

Dr Lüscher: We once discussed such a trial years ago and eventually it was not done. But Sofie, isn't blood pressure such a good surrogate endpoint?

Dr Brouwers: It is.

Dr Lüscher: That we could actually be rather happy with the results in blood pressure.

Dr Brouwers: I think we have 2 options or in parallel, so to say. So, I think blood pressure has been proven to be a good surrogate endpoint and, as we earlier stressed, there's only outcome data for the triple therapy that we advise in the guidelines first line, and all the other hypertensive treatments haven't shown outcome data. So there, also we rely on this surrogate endpoint of blood pressure lowering. And then, of course, hypertension-mediated organ damage is a very valid intermediate endpoint that we can use and that is widely used to look at long-term effects of a new intervention or a new drug. So, I think that is really a good way to continue as we discussed that outcome trials are actually unfeasible.

Dr Lüscher: Well, Felix Malfoud actually did a trial with MRI, and so it seems that it's also working in terms of reducing left ventricular hypertrophy, doesn't it?

Dr Schmieder: Yeah. It's very nice trial, it is corroborated also by another group, so we know now renal denervation decreases left ventricular hypertrophy. Whether this decrease is in addition or, let's say, more exaggerated than just related to blood pressure doesn't matter at all, but we have a significant decrease. As you know, a decrease in LVH means an improvement in cardiovascular prognosis.

Dr Lüscher: So would the regulation agencies like EMA and FDA, would they approve such a treatment based on blood pressure?

Dr Schmieder: Yeah, very clear. Clear yes. They still accept or they accept blood pressure is a valid biomarker.

Dr Lüscher: Like LDL, for example.

Dr Schmieder: Like LDL, for example, like HbA1c. You can also get an approval for an antidiabetic drug. So they really ask, of course, for more data post marketing. This is good, but I think we will come up with more data on the left hypertension-mediated damage, such as LVH, proteinuria, changes in vascular structure, or even maybe some cognitive decline prevention by applying questionnaires or so.

Dr Lüscher: Well, ladies and gentlemen, here you've got the European position on renal denervation in patients with arterial hypertension, and the message is renal denervation works in patients with high blood pressure, it lowers systolic blood pressure by around 10 mm Hg, but to consider such a procedure, please first use three different drugs, including a diuretic, and make sure that the patients still have a blood pressure above 140/90 mm Hg. You have to exclude the white coat hypertension and secondary causes of hypertension, and then consider it and talk to your patient because it's a procedure, it's not another pill, but it's a one-shot procedure with long-term effect. So thank you very much for listening. Please visit the questions at the end of this session to make sure you learned what we taught. And I hope you enjoyed it. Thank you very much for attending.

This transcript has not been copyedited.

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