Outcome data for renal denervation: craving the unattainable?

From the outset, registries and studies consistently demonstrated the safety of catheter-based renal denervation (RDN); however, there has been considerable controversy regarding its effectiveness in lowering blood pressure. During the last 5 years, the RADIANCE and SPYRAL trial programs have conclusively proven that ultrasound and radiofrequency RDN using the Paradise (ReCor, Palo Alto, CA, USA) and Symplicity Spyral (Medtronic, Santa Rosa, CA, USA) catheter systems lower office and ambulatory BP compared with sham in a broad range of patients with hypertension, including resistant hypertension [ 1 ]. These trial programs have led to their approval by the US Food and Drug Administration (FDA) for the treatment of uncontrolled hypertension. In recognition of the evidence coming from second-generation sham-controlled trials, both the 2022 European Society of Cardiology (ESC)’s Council on Hypertensio n/ European Association of Percutaneous Cardiovascular Interventions (EAPCI) clinical consensus statement [ 1 ] and the 2023 European Society of Hypertension (ESH)’s hypertension guidelines [ 2 ] consider RDN a treatment option in patients with resistant hypertension and those with uncontrolled hypertension despite the use of antihypertensive drug combination or if drug treatment elicits serious side effects and poor quality of life (class II recommendation in the ESH guidelines [ 2 ]). Additionally, data from three trials conducted in China provide further evidence supporting the BP-lowering efficacy of radiofrequency RDN using the Iberis (CE-marked), Netrod (CE-marked), and SyMap catheter systems. The latter catheter system has a unique approach using electric stimulation to identify hot spots, whose stimulation should increase BP, and which are subsequently ablated, and cold or neutral spots, which should be avoided [ 3 ].