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Renal denervation - can we press the "ON" button again?
Jacek Kądziela1, Ewa Warchoł-Celińska2, Aleksander Prejbisz2
1Department of Interventional Cardiology and Angiology, Institute of Cardiology, Warsaw, Poland.
Abstract:
Nearly ten years ago percutaneous renal denervation (RDN) was introduced in clinical trials as a possible method of interventional treatment of resistant hypertension. The promising results of the first clinical trials initiated the intensive development of this method. However, the role of percutaneous renal denervation in the treatment of patients with resistant hypertension has been questioned since the results of the Symplicity HTN-3 trial have been published. It also resulted in downgrading the indications for RDN in the European Society of Cardiology/European Society of Hypertension Guidelines 2018. The authors discuss potential shortcomings of that trial, describe new generation devices and present the results of recently published trials: SPYRAL HTN-OFF MED, SPYRAL HTN-ON MED, RADIANCE-HTN SOLO and RADIOSOUND-HTN. The results of studies in patients with obstructive sleep apnea are also summarized and discussed. The upcoming large trials (SPYRAL PIVOTAL, RADIANCE II) are outlined - the results of those trials are expected to be published in the next 2-3 years. Until then, according to the European guidelines, the use of device-based therapies is not recommended for the treatment of hypertension, unless in the context of clinical studies and randomized controlled trials.
Insights
Percutaneous renal denervation (RDN) for resistant hypertension shows evolving results. Recent trials with new devices suggest potential, but guidelines currently limit its use outside clinical studies.
Area of Science:
- Cardiovascular Interventions
- Hypertension Management
- Medical Device Technology
Background:
- Percutaneous renal denervation (RDN) emerged as a promising interventional treatment for resistant hypertension.
- Initial trials showed positive outcomes, driving significant development in RDN technology.
- The Symplicity HTN-3 trial raised questions about RDN's efficacy, leading to revised European guidelines in 2018.
Purpose of the Study:
- To review the evolution of percutaneous renal denervation for resistant hypertension.
- To discuss the impact of the Symplicity HTN-3 trial and subsequent guideline changes.
- To present results from recent RDN trials and discuss future research directions.
Main Methods:
- Review of published clinical trials on percutaneous renal denervation.
- Analysis of outcomes from recent studies including SPYRAL HTN-OFF MED, SPYRAL HTN-ON MED, RADIANCE-HTN SOLO, and RADIOSOUND-HTN.
- Inclusion of data from studies involving patients with obstructive sleep apnea.
Main Results:
- The Symplicity HTN-3 trial's results led to a re-evaluation of RDN's role in resistant hypertension treatment.
- Newer generation devices and recently published trials show varied but potentially improved outcomes.
- Studies in patients with obstructive sleep apnea are also being considered.
Conclusions:
- Current European guidelines recommend against device-based therapies for hypertension outside of clinical trials.
- Upcoming large trials like SPYRAL PIVOTAL and RADIANCE II are expected to provide further clarity on RDN's efficacy.
- Further research and large-scale trials are necessary to establish the definitive role of RDN in hypertension management.