European consensus group calls for standards to move renal denervation field forward

May 19, 2015, EuroPCR

Experts participating in a European Clinical Consensus Conference (CCC) have concluded that research into the use of renal denervation for high blood pressure in patients unable to control the disease using a multi-drug regimen should not be abandoned until high-quality research is completed according to agreed-upon standards.

"Focused, collaborative high-quality research will be necessary to ensure that future patients are neither denied an effective therapy, nor needlessly put at risk from procedures that bring no benefits," the authors, led by Dr. Felix Mahfoud of Saarland University Hospital, Homburg/Saar, Germany, write.

The group's conclusions, including a roadmap for future research into non-drug treatment for resistant hypertension, is published today in the European Heart Journal and are the focus of a special session Wednesday at EuroPCR 2015.

Observational studies as well as three randomised, controlled trials support the safety and efficacy of the therapy, but smaller studies as well as the large, single-blind, randomised, sham-controlled Symplicity HTN-3 trial failed to show any benefit to . The therapy uses radiofrequency energy or other ablation methods, delivered by a catheter, to disrupt the nerve signals travelling to and from the kidney, with the aim of lowering systolic blood pressure. In the wake of the Symplicity HTN-3, some clinicians have refused to endorse the procedure. Others, pointing to a significant unmet need, have argued it's too soon to abandon the investigative procedure, the CCC paper notes.

In their consensus document, Mahfoud and colleagues examine procedural aspects, patient selection, and clinical trials, reaching a number of important conclusions.

  • At the procedural level, practitioners have learned that getting effective results with renal is not as simple as it first seemed, particularly as it applies to achieving "complete" ablation. Better preclinical studies are needed, as are reliable markers to determine whether or not nerve ablation has been successful.
  • In terms of the appropriate patient group, the CCC concluded that selecting "last resort" patients with high taking three or more drugs may not necessarily be the best patients in whom to use or indeed study the emerging therapy. Younger patients with moderate hypertension might actually have anatomy more suited to lasting results.
  • With regards to appropriate clinical trials, the CCC strongly supports the use of ambulatory blood pressure monitoring, both to determine the response to renal denervation, but also as a prerequisite for enrolling a patient in a RDN study. Other key factors for future research include how to measure adherence to drugs, and how to standardize treatment during the study "run-in period." Finally, the requirement of using a sham-control procedure—and its inherent risks—may need to be dispensed with if lower-risk hypertension patients are studied, they propose.

Most of all, renal denervation research is in desperate need of standardization, the authors write. "Treatments, populations, methods, and adherence measures need to be highly consistent to avoid inconclusive or biased results."

"The open questions around renal denervation touch upon a large number of specialties from interventional cardiologists to hypertension experts and molecular biologists," Dr. Mahfoud commented. "The future of the therapy will depend on closer interactions at all levels, necessitating focused collaborative high-quality research, smaller projects targeting specific questions as well as large-scale multidisciplinary research programmes."

Explore further: EuroPCR 2014 session defines future horizons for renal denervation

More information: Mahfoud F, Bohm M, Azizi M, et al. Proceedings from the European clinical consensus conference for renal denervation: considerations on future clinical trial design. Eur Heart J 2015; DOI: DOI: 10.1093/eurheartj/ehv192

Related Stories

EuroPCR 2014 session defines future horizons for renal denervation

May 27, 2014
During EuroPCR 2014, Felix Mahfoud, University Hospital in Homburg, Germany, and Konstantinos Tsioufis, University of Athens, Greece, reflected on the potential future role of modulation of the sympathetic nervous system ...

Unexpected outcome of SYMPLICITY HTN-3 trial of renal denervation to lower blood pressure

December 8, 2014
A new analysis of an important trial of the blood pressure-lowering procedure, renal denervation, shows that the main results may have been affected by a number of confounding factors that partially explain the unexpected ...

One-year data from SYMPLICITY HTN-3 confirm findings from six month analysis

September 2, 2014
Longer-term follow-up data from the SYMPLICITY HTN-3 trial confirmed both the safety and absence of clinical benefit of renal denervation, according to the 12 month results presented for the first time at ESC Congress today ...

ESC recommends patients and centres for renal denervation

April 25, 2013
Up to 10 per cent of patients with high blood pressure are resistant to treatment, which puts them at increased risk of cardiovascular events, including heart attacks. Clinical trials show that catheter-based renal denervation ...

Renal denervation shows no benefit in resistant hypertension

March 31, 2014
Renal denervation fell short of primary and secondary efficacy goals in patients with severe resistant hypertension but did meet the primary safety endpoints, according to keenly awaited data from SYMPLICITY HTN-3 presented ...

Renal denervation achieves significant and sustained blood pressure reduction

August 27, 2012
Renal denervation leads to significant and sustained blood pressure reduction for up to 18 months in patients with treatment resistant hypertension, according to research presented at ESC Congress 2012. The new clinical data ...

Recommended for you

Beetroot juice supplements may help certain heart failure patients

February 22, 2018
Beetroot juice supplements may help enhance exercise capacity in patients with heart failure, according to a new proof-of-concept study. Exercise capacity is a key factor linked to these patients' quality of life and even ...

Heart researchers develop a new, promising imaging technique for cardiac arrhythmias

February 22, 2018
Every five minutes in Germany alone, a person dies of sudden cardiac arrest or fibrillation, the most common cause of death worldwide. This is partly due to the fact that doctors still do not fully understand exactly what ...

Scientists use color-coded tags to discover how heart cells develop

February 22, 2018
UCLA researchers used fluorescent colored proteins to trace how cardiomyocytes—cells in heart muscle that enable it to pump blood—are produced in mouse embryos. The findings could eventually lead to methods for regenerating ...

'Beetroot pill' could help save patients from kidney failure after heart X-ray

February 22, 2018
Beetroot may reduce the risk of kidney failure in patients having a heart x-ray, according to research led by Queen Mary University of London.

Women once considered low risk for heart disease show evidence of previous heart attack scars

February 20, 2018
Women who complain about chest pain often are reassured by their doctors that there is no reason to worry because their angiograms show that the women don't have blockages in the major heart arteries, a primary cause of heart ...

Can your cardiac device be hacked?

February 20, 2018
Medical devices, including cardiovascular implantable electronic devices could be at risk for hacking. In a paper publishing online today in the Journal of the American College of Cardiology, the American College of Cardiology's ...

0 comments

Please sign in to add a comment. Registration is free, and takes less than a minute. Read more

Click here to reset your password.
Sign in to get notified via email when new comments are made.