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European consensus document details patients, centers suited for renal denervation
The European Society of Cardiology and the European Association of Percutaneous Cardiovascular Interventions have issued an expert consensus document highlighting patient and center selection, as well as current evidence and potential new indications for renal denervation.
“The hope is that insurance companies and health care providers will read [this document] and only pay for those centers and especially for those patients who fit the criteria published in the paper,” Felix Mahfoud, MD, one of the paper’s authors, said in an accompanying press release. “The problem right now is that there are no European criteria for determining which patients are most likely to benefit and which centers have the necessary experience.”
Patient considerations
In the consensus document, Mahfoud and more than 20 other representatives of ESC and European Association of Percutaneous Cardiovascular Interventions (EAPCI) provide insights on renal denervation from a physician and patient standpoint based on current available data. The authors discuss the efficacy and safety data from the Symplicity HTN-1 and HTN-2 trials and emphasize that treated patients must have realistic expectations, as BP reductions rarely occur immediately after the procedure and often take several weeks to months, suggesting that a slowly progressive resetting of sympathetic neural regulation occurs. Additionally, patients should be aware that renal denervation is not a cure for hypertension and is unlikely to significantly reduce pill burden in most patients.
Felix Mahfoud
In selecting the right patients for the procedure, Mahfoud and authors recommend that current indications for the procedure include a renal artery length >20 mm with a diameter of >4 mm, whereas arteries with visible stenosis, calcification or atheromatous plaques represent relative contraindications.
Additional criteria that patients should comply with before renal denervation is considered include:
- Office-based systolic BP ≥160 mm Hg (≥150 mm Hg in patients with type 2 diabetes);
- At least three antihypertensive drugs in adequate dosage and combination (including a diuretic);
- Lifestyle modification;
- Exclusion of secondary hypertension;
- Exclusion of pseudo-resistance using ambulatory BP monitoring (average BP >130 mm Hg or mean daytime BP >135 mm Hg);
- Preserved renal function (glomerular filtration rate ≥45 mL/min/1.73 m2).
Center selection
Because secondary causes of hypertension are common in patients with uncontrolled hypertension, a detailed screening process is necessary to identify patients with potentially curable forms of hypertension, as renal denervation is not an effective therapy in these patients, the authors wrote.
Appropriate centers for the procedure should be specialized in the management of hypertension, with at least one hypertension expert being actively involved in the treatment and screening process, according to the authors. The procedure should be performed by interventional cardiologists or angiologists with training in percutaneous renal artery access, and the appropriate expertise for centers should be defined as more than 25 renal interventions per year.
Potential indications on horizon
Up ahead, should future research confirm initial reports, possible patient populations that may benefit from renal denervation are those with diabetes and insulin resistance, chronic HF, chronic kidney disease, effects of arrhythmia and hypertensive end-organ damage.
“We have known for decades that high sympathetic activity could be a target for treatment, but until now we haven’t had a way to do it. We now have a new treatment modality which allows us to reduce sympathetic activity, and I’m optimistic that we will get new indications for renal denervation,” Mahfoud said.
Disclosure: Mahfoud has received scientific support from Medtronic, ReCor, St. Jude Medical and Vessix, and speaker honorarium from Medtronic.
Perspective
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With a new technique, it’s important to have governance and control on the introduction so that it’s properly distributed. When coronary angioplasty was introduced, it came in with no particular restriction on who did it and on whom it was done. It was many years before the COURAGE trial was published, which was the first study to say that perhaps we don’t need to do all of these angioplasties and that giving patients medical therapy might be enough. So with renal denervation, the first interventional technique in hypertension, this consensus document was an attempt to try to identify the individuals for whom this procedure should be tried first, since there are hundreds of millions of people with high BP around the world. The physicians who performed the most procedures from European centers collaborated on this document and provide a scientific introduction to a very exciting technique.
Another important aspect of this document is that it says we don’t really know much about the effect of renal denervation beyond 3 years. There are scientific data from animals that suggest sympathetic nerves grow back 4 to 6 years after the procedure. So whether the benefits we’ve observed in patients at 3 years will be seen at 6 years, we don’t know yet.
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