NICE did a rapid review of the published literature on the efficacy and safety of this procedure. This comprised a comprehensive literature search and detailed review of the evidence from 5 sources, which was discussed by the committee. The evidence included 2 randomised controlled trials and 3 single-arm studies. It is presented in the summary of key evidence section in the interventional procedures overview. Other relevant literature is in the appendix of the overview.
The professional experts and the committee considered the key efficacy outcomes to be: reduction in blood pressure, reduction in use of antihypertensive medicines, reduction in end-organ damage and improvement in quality of life.
The professional experts and the committee considered the key safety outcomes to be: pain, bleeding and damage to renal arteries or other structures.
Patient commentary was sought but none was received.
There is a placebo effect on blood pressure reduction in the evidence, and the committee was informed that such an effect is common in hypertension trials.
The evidence includes diverse groups and there may be subgroups who would benefit from the procedure.
This is an invasive procedure. Although the evidence does not show major safety concerns, this is based on evidence from limited patient numbers and needs confirming over a longer term. So, more evidence is needed on safety.
This procedure is a single intervention and not intended to be repeated.
Technology has evolved over time and renal accessory arteries can be reached using a smaller catheter to achieve a more compete denervation.
ISBN: 978-1-4731-6784-1