The future of renal denervation in Europe: A five-year perspective

Technological advancements

Recent advancements in RDN technology have significantly improved the precision and safety of the procedure, establishing now at least 3 different approaches namely ultrasound, radiofrequency and more recently alcohol-based RDN. Third-generation devices will utilize more sophisticated algorithms to ensure accurate and more consistent nerve disruption. Additionally, innovations in imaging techniques and functional approaches (pre/ post procedural stimulation of sympathetic nerves) will further enhance the quality of the procedure allowing us to assess if RDN has been exhaustive. Finally, radial approaches and shorter procedural time are expected to drive broader adoption and success rates of RDN in Europe.

Clinical outcomes and research

Clinical trials in the past few years have provided compelling evidence supporting the efficacy of RDN. The SPYRAL and RADIANCE programs showed promising results in drug-naïve patients and those treated with a wide range of drugs up to uncontrolled resistant hypertensive patients respectively with RF and US-based RDN recently joined by the TARGET BP program evaluated alcohol-mediated RDN.
As more long-term data become available (mostly prospective observational studies), it is anticipated that the clinical community will gain greater confidence in RDN, potentially establishing it as a standard treatment for hypertension at an earlier stage. A potential indication will move from BP lowering therapy to neuromodulation by sympathy inhibition. This will support the development of RDN in both HF with reduced or preserved EF but also in patients with arrhythmias (both atrial and ventricular in combination with available treatment) and then move to prevalent diseases like CKD, metabolic syndrome or clinical situations strongly linked to sympathetic overdrive (i.e. PCOS). Finally, expanding the concept of denervation to other territories (hepatic or pulmonary arteries) will open the concept of sympathomodulation in NASH, metabolic syndrome or pulmonary hypertension.

Regulatory landscape

The regulatory environment in Europe is evolving to accommodate the re-emergence of RDN. The European Society of Hypertension (ESH) and European Society of Cardiology (ESC) are likely to update their guidelines to incorporate RDN as an option for hypertension and related conditions and even beyond HTN, especially as further evidence solidifies its efficacy and safety. The European Medicines Agency (EMA) and national health agencies will play crucial roles in approving new RDN devices, with a focus on ensuring patient safety and device effectiveness. A new standard of care being RDN, new devices will need to perform studies with active comparators or find indications where sham-controlled trials are acceptable.

Integration into clinical practice

The integration of RDN into routine clinical practice will depend on several factors, including clinician education, patient selection criteria, and healthcare system support. Training programs and workshops will be essential to familiarize interventional cardiologists, radiologists and more generally all physicians involved in Hypertension care with the latest techniques and technologies. Furthermore, the development of robust patient selection protocols will help identify those who are most likely to benefit from RDN through the identification of biomarkers or phenotypes thanks to AI, thereby optimizing outcomes. Healthcare systems will also need to consider cost-effectiveness analyses to justify the inclusion of RDN in treatment protocols.

Conclusion

The future of renal denervation in Europe over the next five years appears promising, with advancements in technology, positive clinical trial outcomes, and a supportive regulatory environment paving the way for its broader adoption. As more data become available and the medical community becomes more adept at implementing this technology, RDN has the potential to become a cornerstone in the management of hypertension at an earlier step in less complicated patients before moving to new indications( i.e. HF, arrhythmia, OSA..). However, ongoing research, clinician training, and patient education will be critical to fully realize its potential and ensure its successful integration into clinical practice.

The Essentials - Hypertension