Position paper on renal denervation for the treatment of hypertension
References
News - Aug. 11, 2021After the publication of the 2018 ESH/ESC Guidelines on the management of hypertension, five new sham-controlled RCTs were published which consistently demonstrated that renal denervation (RDN) is an evidence-based option to treat hypertension [1-5]. The ESH position paper provides information about the efficacy, durability and safety of RDN in patients with hypertension. In addition, knowledge gaps that still exists are listed and updated recommendations regarding the pathway for clinical use of RDN are described.
The five completed sham-controlled RCTs consistently demonstrated that RDN was effective and well tolerated in patients with hypertension, in the presence and absence of concomitant antihypertensive pharmacotherapy [1-5]. The decrease in ambulatory BP in the RDN groups ranged from -4.7 to -9.0 mmHg systolic and from -3.7 to -6.0 mmHg diastolic in the five RCTs. The decrease in office BP ranged from -9.0 to -10.8 mmHg systolic and from -5.0 to -0.5 mmHg diastolic. No peri-procedural, short-term or long-term (data available up to 3 years) safety signals have been observed. The durability of BP lowering effects of RDN have not been extensively investigated yet, although available follow-up data for up to 3 years suggests that the antihypertensive effect of RDN in humans is durable.
The authors of the position paper state that several open questions regarding RDN therapy remain. One of the major challenges is that a large variability in BP response after RDN treatment exists. Identification of predictors of BP response to RDN is therefore of importance to select patients that will benefit most from RDN therapy. The authors also stress that a structured and transparent pathway for clinical use of RDN needs to be established.
References
1. Townsend RR, Mahfoud F, Kandzari DE, Kario K, Pocock S, Weber MA, 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; 390:2160–2170.
2. Kandzari DE, Böhm M, Mahfoud F, Townsend RR, Weber MA, Pocock S, et al. Effect of renal denervation on blood pressure in the presence of antihypertensive drugs: 6-month efficacy and safety results from the SPYRAL HTN-ON MED proof-of-concept randomised trial. Lancet 2018; 391:2346–2355.
3. Azizi M, Schmieder RE, Mahfoud F, Weber MA, Daemen J, Davies J, et al. Endovascular ultrasound renal denervation to treat hypertension (RADIANCE-HTN SOLO): a multicentre, international, single-blind, randomised, sham-controlled trial. Lancet 2018; 391:2335–2345.
4. Böhm M, Kario K, Kandzari DE, Mahfoud F, Weber MA, Schmieder RE, et al. Efficacy of catheter-based renal denervation in the absence of antihypertensive medications (SPYRAL HTN-OFF MED pivotal): a multicentre, randomised, sham-controlled trial. Lancet 2020; 395: 1444–1451.
5. Azizi M, Sanghvi K, Saxena M, Gosse P, Reilly JP, Levy T, et al. Ultrasound renal denervation for hypertension resistant to a triple medication pill (RADIANCE-HTN TRIO): a randomised, multicentre, single-blind, sham-controlled trial. Lancet 2021; May 14: [Epub ahead of print; S0140-6736/21)00788-1.
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