European Societies Define Best Practices for Performing Renal Denervation

Renal denervation safely and effectively lowers blood pressure, but it is not for all patients with hypertension and should not be performed in every cath lab, according to guidance from the European Society of Cardiology (ESC)’s Council on Hypertension and the European Association of Percutaneous Cardiovascular Interventions (EAPCI).

As an adjunct to lifestyle modification and antihypertensive medications, the procedure may be considered in patients who have uncontrolled hypertension despite treatment with at least three medications, as confirmed by ambulatory BP measurements, lead author Emanuele Barbato, MD, PhD (Sapienza University of Rome, Italy), president of the EAPCI, and colleagues write in a consensus statement published online last week in EuroIntervention.

Renal denervation—which has been approved by regulators in Europe but has not yet been cleared by the US Food and Drug Administration—also may be considered in patients who are either unable or unwilling to take antihypertensive medications over the long term, they advise.

Importantly, there should be a shared decision-making process with a well-informed patient that incorporates consideration of global cardiovascular risk, hypertension-mediated organ damage, and/or cardiovascular complications, as well as input from a multidisciplinary hypertension team, before the procedure is performed, they recommend.

“There is no question left that it works, that it lowers blood pressure, and I hope that now physicians understand that this is not a cure—we will not cure patients from their hypertension,” senior author Felix Mahfoud, MD (Universitätsklinikum des Saarlandes and Saarland University, Homburg, Germany), secretary of the ESC Council on Hypertension, told TCTMD. “But in addition to lifestyle and antihypertensive drugs, in certain patients, it’s an appropriate, interesting, and appealing approach to lower blood pressure.”

Informing the Community

Explaining the need for the new statement, Mahfoud noted that the 2018 hypertension guidelines from the ESC and the European Society of Hypertension (ESH) contain a recommendation against using device-based therapies like renal denervation for routine treatment until additional evidence regarding safety and efficacy is available.

Since then, several randomized, sham-controlled trials have reported results, with most meeting their primary endpoints and showing that renal denervation—with radiofrequency or ultrasound catheters—safely lowers BP. Those findings have fueled a resurgent field, and in 2021, the ESH released a statement placing renal denervation as a third major option for the treatment of hypertension, alongside lifestyle modification and drug therapy.

But while awaiting the next full iteration of the European hypertension guideline, expected sometime in 2024, the medical community needed updated information to inform practice around the use of renal denervation, a gap filled by this new statement, Mahfoud said.

In it, the authors review all of the accumulated evidence from the past 15 years on the safety and efficacy of the procedure and provide guidance on patient selection, requirements for centers, procedural aspects, and considerations for future trial designs.

Overall, the trial evidence demonstrates that renal denervation significantly reduces blood pressure and is safe, with complication rates consistent with procedures involving transfemoral arterial access and rates of de novo renal artery stenosis and worsening kidney function that would be expected in a hypertensive population.

Such a broad range of patients was enrolled in the trials, however, that it was deemed necessary to try to identify those who would be better candidates for the procedure, Mahfoud said. Putting some parameters around the types of patients that may be treated, the authors point to those with confirmed uncontrolled hypertension on at least three medications, including a diuretic, and an estimated glomerular filtration of 40 mL/min/1.73 m² or higher. “It is strongly advised to exclude secondary causes of hypertension before renal denervation is considered,” they write.

Decisions about renal denervation should be guided by a multidisciplinary hypertension team that includes experts in hypertension and percutaneous cardiovascular interventions. These teams might also include clinical cardiologists, angiologists, and nephrologists at some centers, the authors say.

The statement also lays out recommendations regarding the type of training that should be completed before starting a renal denervation programs and provides guidance on preprocedural imaging, patient preparation, and procedural considerations.

The procedure should be done in “centers of excellence,” Mahfoud said. “We believe this should not be done everywhere in every cath lab, because it’s not only about the procedure, but also about patient selection and exclusion of secondary causes of hypertension. You need centers who are trained in renal artery interventions, and although the procedure appears to be very safe, it’s important that you can handle potential complications appropriately.”

Remaining Questions

Although renal denervation has been shown to reduce blood pressure, there are some areas of research that require more work, Mahfoud said. For one, not all patients respond to the intervention, and there hasn’t been a lot of progress in coming up with ways to identify that group, which would inform recommendations about who should not be treated.

In addition, some may question whether there is still a need for a large trial powered for clinical outcomes to show that renal denervation is not only lowering blood pressure, but also reducing endpoints like stroke. Such a trial would be challenging because it would require around 20,000 patients, Mahfoud said. “But it’s also potentially not really needed,” he added, “because blood pressure is such a strong surrogate” for morbidity and mortality.

Moreover, beyond hypertension, renal denervation is being evaluated for conditions like atrial fibrillation, heart failure, and ventricular tachycardia. Mahfoud estimated that results will start coming out from those studies in the next 2 to 3 years.