MY PRACTICE. . . renal denervation – dead in the water?

Created - 11.06.2014

“The higher you climb the further you fall”. Nothing in recent years can match the spectacular rise of renal denervation and its recent demise with a temporary moratorium enforced across the NHS and private sector in the U.K. That has never been seen before in my 25 years of practice.

Many including myself have campaigned for more rigorous evaluation of devices used by interventional radiologists and recently trials have questioned the value of procedures such as renal stents, vertebroplasty, emergency EVAR, below the knee drug eluting balloons and CCSVI. However is the reaction to the press release issue by Medtronic on January 9th 2014 going too far the other way?

Renal denervation is a nice story, the concept is logical and a proof of principle (HTN-1) trial followed by a randomised controlled trial (HTN-2) hit the headlines across the world. Here was a procedure which could dramatically lower blood pressure (30mm systolic) in a group of patients with high risk “resistant” hypertension. In some countries e.g. Germany there was an almost explosive uptake and before long other indications started to appear such as heart failure and sleep apnoea. Other countries however struggled to fund or commission RDN not helped I’m sure by the high prevalence of hypertension (approximately 1/3 world population). The U.K. has been particularly slow to commission this procedure in spite of favourable guidance being issued by both NICE and the Joint Societies Position paper. Commissioners may now be quietly smiling in the corner!

The press release however remains a press release and we have not seen any data not has the data been peer reviewed. Things should be clearer once the findings are presented at the American Congress of Cardiology in March 2014 followed by a peer reviewed publication. There has been a mixed response from industry with Covidien removing its device from the market and cancelling the RAPID 2 trial. St Jude have also closed their trials as have Medtronic (HTN-4). Other players such as Boston Scientific and Cordis remain committed to the procedure and we have yet to hear firmly from the other sixty or so companies who are investing in this technology.

I doubt RDN is a dead duck but it`s going to be a tough struggle now with further research being mandatory. Funding for that is less clear, the HTA recently turned down a proposal from the Joint Societies in the UK largely because of the research costs of the device. Industry will have to help here and it`s good to see confident engagement from several players.

The future, well it`s a toughening world and we are going to see more RCTs looking at interventional procedures and there will be a call for sham arm studies although often difficult to implement. Evidence based medicine is good for patients and healthcare providers alike, but don`t get despondent there is still lots of work for Interventional Radiologists and we may still see a come back for RDN.

Jon Moss