Is Renal Denervation Back?

Summary and Comment |
August 29, 2017

Is Renal Denervation Back?

  1. Pascal Meier, MD

In a proof-of-concept trial, the procedure reduced blood pressure in low-risk patients who were not taking oral antihypertensives.

  1. Pascal Meier, MD

Renal sympathetic hyperactivity is a contributor to hypertension, and renal denervation (RDN) by percutaneous ablation was for a time considered a very promising novel treatment approach. Early, nonrandomized studies showed dramatic reductions of blood pressure with RDN in patients with resistant hypertension, but later studies with sham controls did not confirm the initial results (NEJM JW Gen Med May 1 2014 and N Engl J Med 2014; 370:1393).

Now, investigators have performed a manufacturer-funded, proof-of-concept, sham-controlled, multicenter, randomized study in 80 patients with mild-to-moderate hypertension who were not on blood pressure medication (ClinicalTrials.gov NCT02439749). At 3 months, ambulatory systolic blood pressure had dropped by 5.5 mm Hg in the RDN group and was unchanged in the sham group. Office systolic blood pressure was reduced by 10.0 mm Hg in the denervation group versus 2.3 mm Hg in the sham group. No major adverse events occurred in either group. Of the 35 patients in the RDN group, systolic blood pressure dropped in 25 and did not change or increased in 10.

Comment

In contrast to previous sham-controlled trials, RDN had a significant effect on blood pressure in this study. Possible explanations for these results include the absence of “confounding” background antihypertensive treatment and the use of an improved, multielectrode device to deliver more ablations per procedure than previous devices. Although the study was not powered for any endpoint and the observed effect is much more modest than in the very first studies, being able to choose a one-time procedure over continuous medical therapy could appeal considerably to patients. However, these findings would first need to be confirmed in a larger trial, and even larger trials would need to show that blood pressure reduction via RDN translates into improvements in clinical outcomes comparable to those of medical therapy.

Editor Disclosures at Time of Publication

  • Disclosures for Pascal Meier, MD at time of publication Editorial boards Open Heart Leadership positions in professional societies European Society of Cardiology (Communication Committee), European Association of Percutaneous Cardiovascular Interventions (Chair, Web & Communication Committee)

Citation(s):

Reader Comments (1)

Rajeev Gupta, MD DM (Cardiology) Physician, Cardiology, Mediclinic Al Jowhara Hospital, Al Ain, UAE

Congratulations for the success. However, limited lowering of BP with expensive invasive procedure, how far is justified? We need need hard outcome data, before it could be recommended. However the concept is worth further exploration.

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