Professor Bernard Gersh from Mayo Clinic in Rochester, USA, speaks to Cardio Debate & Radcliffe Cardiology about renal denervation, during the ESC2016 Congress held in Rome, Italy.
Is renal denervation a ‘dead strategy’?
Well we’ve seen the rise and the fall. We’ve seen great expectations, and the most important trial – SIMPLICTY HYPERTENSION 3 – was completely neutral. And so the question is, will we see a resurrection or a rebirth?
I think for now that’s an unanswered question. What we have learned from SIMPLICITY HYPERTENSION 3 is the power of the placebo. Doing a sham operation, or a sham procedure, taught us a great deal. And I think all trials of these new technologies should introduce a sham procedure.
Having said that, I think there is a high placebo effect, and there are other factors such as statistics regression to the mean. I think the other issue is that the patients in the control arm were well-treated pharmacologically.
But having said that, I don’t think that renal denervation is dead. There are some technical issues, we’ve developed some new catheters, we’ve learned a lot more about how many ablations are required – probably both proximally and distally.
So there are now three ongoing trials that I know of, there may be more. And one or two of them will compare denervation verses no drugs in the short term. The others will compare the denervation with drugs.
And I think the fairest answer is that there is real equipoise, it’s a fascinating area. I don’t think it’s dead. What I can say is that we will know in two years.
These trials that are ongoing are really well designed, and we have learned from SIMPLICTY HYPERTENSION 3, and I do know the design of the ongoing trials and they are very well designed. So we’ll have an answer in two years.