Renal denervation (RDN) represents a device-based hypertension treatment intended to lower sympathetic activity. Only a few years ago, RDN was written off as ineffective after results of the sham-controlled SYMPLICITY HTN-3 trial failed to confirm early trials' reports of significant BP reductions in patients resistant to guideline- based combination drug therapy. However, the trial's design and execution has been questioned by many. Later- on, following recommendations provided by European and US expert groups, defining optimal trial design and methodology and the population of patients to be included, three carefully designed, randomized sham- controlled RDN trials (SPYRAL HTN-OFF MED, SPYRAL HTN-ON MED, and RADIANCE-HTN SOLO) reported consistent, plausible, and clinically meaningful ambulatory and office BP reductions in the short- (2 to 3 months) and mid-term (6 months) with radiofrequency (RF)- or highly focused ultrasound (US)-based RDN while reporting no serious adverse events. The first sham-controlled pivotal trial in patients not receiving concomitant antihypertensive medication also confirmed the efficacy and safety of RF-RDN. Unlike previous studies, these new trials included patients with mild to moderate uncontrolled hypertension treated with no or 1-3 antihypertensive drugs.
Additionally, the Global Symplicity Registry enrolled more than 2800 patients up to date and provides evidence for the effectiveness of RDN in patients with various comorbidities, testing the hypothesis that RDN is effective and durable in these high-risk populations. In the largest international registry of its kind, the efficacy of RDN was similar in patients with and without baseline conditions associated with increased sympathetic activity and irrespective of ASCVD risk. The BP reductions were durable and sustained to 3 years. The rates of new-onset end-stage renal disease and elevation in serum creatinine levels were very low in patients at high and low CV risk.
Other modalities, such as chemical ablation via perivascular injection of alcohol, to RDN are under clinical investigation.
RDN can safely lower blood pressure and represents a complimentary antihypertensive approach to lifestyle modification and drug therapy. In particular patients with uncontrolled hypertension at high cardiovascular risk, non-adherence/intolerability to medication or patients with preference for device-based treatment are potentially candidates for this approach.
Notes to editors
A PCR State-of-the-Art lecture on "The resurgence of renal denervation" by Felix Mahfoud
- o Presentation during the #PCR e-Course - http://www.pcr-ecourse.com
o Session on Main Arena Channel, Thursday 25 June - 18:45 Paris time (UTC+2)
o PCR e-Course: 25, 26, 27 June 2020
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