ESC and EAPCI publish renal denervation consensus statement

Renal denervation represents another treatment option in patients with uncontrolled resistant hypertension and may be used in selected patients deemed intolerant to antihypertensive drugs.

These are among the messages of a new consensus statement published in EuroIntervention following a review of evidence by the European Society of Cardiology (ESC) Council on Hypertension and the European Association of Percutaneous Cardiovascular Interventions (EAPCI).

Initial excitement over the potential for renal denervation as a treatment for hypertension was dampened following the release of initial results of the SYMPLICITY HTN-3 trial in 2014 in which it was shown that at six months, renal denervation did not elicit significant incremental blood pressure lowering benefit compared with a sham procedure.

Subsequently, joint ESC and European Society of Hypertension (ESH) guidelines on the management of arterial hypertension, published in 2018, advocated against the routine use of device-based therapies for hypertension, until further evidence of their safety and efficacy came to light. However, newer sham-controlled trials have revitalised hope in the potential of renal denervation, with a number showing statistically significant and clinically meaningful reductions in blood pressure.

In producing the latest consensus statement, the ESC and EAPCI expert panel have reviewed evidence from several “second-generation” randomised, sham-controlled trials, which, they say, demonstrate the safety and the blood-pressure lowering efficacy of radiofrequency and ultrasound renal denervation.

The second generation of trials have involved either the Symplicity Spyral (Medtronic) multi-electrode radiofrequency device or the Paradise (ReCor Medical) ultrasound system.

“Since the publication of the 2018 ESC/ ESH Guidelines for the Management of Arterial Hypertension, several high-quality, randomised, sham-controlled trials have been published, demonstrating a blood-pressure-lowering efficacy over 24 hours for both radiofrequency and ultrasound renal denervation in a broad spectrum of patients whose hypertension ranges from mild-to-moderate to severe and resistant,” Emanuele Barbato (University of Rome, Rome, Italy) and colleagues write in EuroIntervention

“This expert group proposes that renal denervation is an adjunct treatment option in uncontrolled resistant hypertension, confirmed by ambulatory blood pressure measurements, despite best efforts at lifestyle and pharmacological interventions,” the statement notes. Renal denervation may also be used in patients who are unable to tolerate antihypertensive medications in the long term, the writing committee has concluded.

The authors of the paper suggest that a shared decision-making process, taking into account the patient’s global cardiovascular risk and the presence of hypertension-mediated organ damage, should be followed when considering renal denervation as a