(PARIS, FRANCE) - 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. [1]
"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 renal denervation. 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.
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."
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The CCC was supported by an unrestricted educational grant from Europa Organisation, Toulouse, France. Dr. Mahfoud disclosed research grants to his institution from Medtronic/Ardian, St. Jude Medical, and Recor and speaker honorarium from Medtronic/Ardian and St. Jude Medical.
Contact: Felix Mahfoud < Felix.Mahfoud@uniklinikum-saarland.de >
The Clinical Consensus Group Report will be published May 19 at 8:00 Central European Summer Time. A special session at EuroPCR 2015 focused on the CCC Renal Denervation Findings entitled "Interventional Hypertension Treatment: Moving Forward" will take place Wednesday May 20 from 14:40-16:40 in Room 242AB.
1. 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
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