Patient Selection and Practical Implementation of Renal Denervation in Patients with Treatment-resistant Hypertension

An estimated 1.13 billion people worldwide have hypertension and is a major cause of premature death worldwide.¹

Resistant hypertension is defined as blood pressure (BP) that exceeds 140/90 mm Hg despite the concomitant use of maximally tolerated doses of antihypertensive drugs from more than three drug classes.^2,3 In a meta-analysis of data from 3.2 million patients, the prevalence of true-resistant or apparent treatment-resistant hypertension combined was 25%.⁴ Even within the context of clinical trials that provide medications, rigorous follow-up, and often multidisciplinary treatment, around 25–30% of patients do not achieve adequate BP control.^5,6 The greater the number of medications a patient is on, the lower the adherence.⁷

Experts from the European Society of Hypertension (ESH) have stated that, with individualised treatment, catheter-based renal denervation (RDN) is supported by biological proof for lowering BP that is clinically meaningful and associated with no major adverse events reported in clinical trials.⁸

While RDN was initially only considered as a last resort for patients with treatment-resistant severe hypertension, data from recent clinical trials indicate that the intervention may gain importance when treating patients with uncomplicated hypertension.⁹

RDN for treating hypertension is an emerging clinical procedure and improved catheter design, procedure technique and medication use have confirmed its feasibility. Identifying predictors that could ensure that RDN is effective for all patients treated is important.

Recent sham-controlled pilot studies using the new and improved multi-electrode SYMPLICITY Spyral catheter design, SPYRAL HTN-OFF MED and SPYRAL HTN-ON MED, have reaffirmed the biological proof of principle that RDN can result in a significant BP-lowering effect versus sham controls for subjects with resistant hypertension in the absence or presence of antihypertensive medications, respectively.^10,11,12

Understanding the appropriate patient profile and when to refer is also pertinent. In this regard, patient preference will be an important factor in a shared decision-making process.

With safety and efficacy of RDN established, education is now needed to define how RDN could fit into future clinical practice.

This case-based course brings together opinion leaders engaged in RDN to review the evidence, discuss trial data, and practical aspects around patient selection and management.

REFERENCES

1. The World Health Organisation (2019) Hypertension. Available from: https://www.who.int/news-room/fact-sheets/detail/hypertension (Accessed February 2020).
2. Chobanian AV, Bakris GL, Black HR, et al. The Seventh Report of the Joint National Committee on Prevention, Detection, Evaluation, and Treatment of High Blood Pressure: The JNC 7 report. JAMA 2003;289:2560–72.
3. Mancia G, Fagard R, Narkiewicz K, et al. 2013 ESH/ESC guidelines for the management of arterial hypertension: The Task Force for the Management of Arterial Hypertension of the European Society of Hypertension (ESH) and of the European Society of Cardiology (ESC). Eur Heart J 2013;34:2159–219.
4. Noubiap JJ, Nansseu JR, Nyaga UF, et al. Global prevalence of resistant hypertension: a meta-analysis of data from 3.2 million patients. Heart 2019;105:98–105.
5. Calhoun DA, Jones D, Textor S, et al. Resistant hypertension: diagnosis, evaluation, and treatment: a scientific statement from the American Heart Association Professional Education Committee of the Council for High Blood Pressure Research. Circulation 2008;117:e510–26.
6. Persell SD. Prevalence of resistant hypertension in the United States, 2003-2008. Hypertension2011;57:1076–80
7. Hutchins R, Viera AJ, Sheridan SL, Pignone MP. Quantifying the utility of taking pills for cardiovascular prevention. Circ Cardiovasc Qual Outcomes 2015;8:155–63
8. Schmieder RE, Mahfoud F, Azizi M, et al. European Society of Hypertension position paper on renal denervation 2018. J Hypertens 2018;36):2042–8
9. Jung S, Schmieder RE. The resurrection of renal denervation. E-Journal Cardiol Pract 2019;17:17
10. Townsend RR, Mahfoud F, Kandzari DE, et al. Catheter-based renal denervation in patients with uncontrolled hypertension in the absence of antihypertensive medications (SPYRAL HTN-OFF MED): a randomised, sham-controlled, proof-of-concept trial. Lancet 2017;390:2160–70.
11. Sardar P, Bhatt DL, Kirtane AJ, et al. Sham-controlled randomized trials of catheter-based renal denervation in patients with hypertension. J Am Coll Cardiol 2019;73:1633–42.
12. Böhm M, Townsend RR, Kario K, et al. Rationale and design of two randomized sham-controlled trials of catheter-based renal denervation in subjects with uncontrolled hypertension in the absence (SPYRAL HTN-OFF MED Pivotal) and presence (SPYRAL HTN-ON MED Expansion) of antihypertensive medications: a novel approach using Bayesian design [published online ahead of print, 2020 Feb 7]. Clin Res Cardiol2020;10.1007/s00392-020-01595-z

This activity has been supported by an unrestricted educational grant from Medtronic.

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