Dive Brief:
- The European Society of Cardiology (ESC) said Friday renal denervation may be considered for some patients who have uncontrolled, drug-resistant high blood pressure.
- Previously, the ESC did not recommend renal denervation for use outside of clinical studies. The updated guidelines upgrade the recommendation in light of clinical data generated by Medtronic and Recor Medical.
- The ESC continues to advise against the use of renal denervation as a first-line treatment and in patients with moderate to severely impaired renal function because of a lack of evidence.
Dive Insight:
The ESC published its previous guidelines on the management of arterial hypertension in 2018. At that time, the society said major uncertainties remain “as to the clinical role of renal denervation outside of clinical studies, which should be performed in carefully selected patients at specialist hypertension centres and by experienced operators.”
The ESC’s position that renal denervation should only be used in clinical trials reflected conflicting evidence, such as the success and failure of different studies of Medtronic’s medical device.
Since then, Medtronic and Recor have published more clinical data on their devices. The ESC’s updated position is underpinned by evidence such as long-term, non-randomized, follow-up data from Medtronic studies and three-year data from a Recor trial.
The society said renal denervation has shown “clear promise” in reducing blood pressure but identified “concerns that warrant consideration.” The effect on blood pressure “is relatively modest for an invasive procedure,” cost-effectiveness has not been fully established, and there are no adequately powered trials showing the safe, long-term reduction of cardiovascular events, the ESC said.
That mix of promise and concerns led the ESC to grant a Class IIb recommendation to the procedure in some patients. The society reserves Class IIb for cases when “usefulness/efficacy is less well established by evidence/opinion.” Interventions with Class IIb recommendations may be considered by physicians. The ESC has two stronger recommendations for devices supported by more robust evidence.
The Class IIb recommendation is limited to patients who have uncontrolled hypertension despite taking a three-drug combination, as well as people with high blood pressure who have tried fewer drugs but are at increased risk of cardiovascular events. The ESC said “cost-effectiveness considerations are likely to be optimal in this setting” because the patients are at higher risk of cardiovascular events.
The recommendation is limited to medium- to high-volume centers. “The impact of scaling up renal denervation on usual cardiac department catheterization laboratory workflows is of some concern,” the ESC said, adding that it is important that adopting the intervention does not delay access to “other elective procedures with proven efficacy in reducing [cardiovascular disease] outcomes.”
Medtronic, which sells the Symplicity Spyral renal denervation system in Europe and other markets, published a statement about the new ESC guidelines. Jason Weidman, president of Medtronic’s coronary and renal denervation business, said the guidelines reinforce the procedure as an additional hypertension option.
Medtronic competes with Recor, part of Otsuka Medical Devices, for the market.