Renal denervation for the management of resistant hypertension
File(s)
Published version
Author(s)
Patel, HC
Hayward, C
Di Mario, C
Type
Journal Article
Abstract
Renal sympathetic denervation (RSD) as a therapy for patients with resistant
hypertension has attracted great interest. The majority of studies in this field have demonstrated
impressive reductions in blood pressure (BP). However, these trials were not randomized or shamcontrolled
and hence, the findings may have been overinflated due to trial biases. SYMPLICITY
HTN-3 was the first randomized controlled trial to use a blinded sham-control and ambulatory
BP monitoring. A surprise to many was that this study was neutral. Possible reasons for this
neutrality include the fact that RSD may not be effective at lowering BP in man, RSD was not
performed adequately due to limited operator experience, patients’ adherence with their antihypertensive
drugs may have changed during the trial period, and perhaps the intervention only
works in certain subgroups that are yet to be identified. Future studies seeking to demonstrate
efficacy of RSD should be designed as randomized blinded sham-controlled trials. The efficacy
of RSD is in doubt, but many feel that its safety has been established through the thousands of
patients in whom the procedure has been performed. Over 90% of these data, however, are for
the Symplicity™ system and rarely extend beyond 12 months of follow-up. Long-term safety
cannot be assumed with RSD and nor should it be assumed that if one catheter system is safe
then all are. We hope that in the near future, with the benefit of well-designed clinical trials, the
role of renal denervation in the management of hypertension will be established.
hypertension has attracted great interest. The majority of studies in this field have demonstrated
impressive reductions in blood pressure (BP). However, these trials were not randomized or shamcontrolled
and hence, the findings may have been overinflated due to trial biases. SYMPLICITY
HTN-3 was the first randomized controlled trial to use a blinded sham-control and ambulatory
BP monitoring. A surprise to many was that this study was neutral. Possible reasons for this
neutrality include the fact that RSD may not be effective at lowering BP in man, RSD was not
performed adequately due to limited operator experience, patients’ adherence with their antihypertensive
drugs may have changed during the trial period, and perhaps the intervention only
works in certain subgroups that are yet to be identified. Future studies seeking to demonstrate
efficacy of RSD should be designed as randomized blinded sham-controlled trials. The efficacy
of RSD is in doubt, but many feel that its safety has been established through the thousands of
patients in whom the procedure has been performed. Over 90% of these data, however, are for
the Symplicity™ system and rarely extend beyond 12 months of follow-up. Long-term safety
cannot be assumed with RSD and nor should it be assumed that if one catheter system is safe
then all are. We hope that in the near future, with the benefit of well-designed clinical trials, the
role of renal denervation in the management of hypertension will be established.
Date Issued
2015-12-03
Date Acceptance
2015-10-15
Citation
Integrated Blood Pressure Control, 2015, 2015 (8), pp.57-69
ISSN
1178-7104
Publisher
Dove Medical Press
Start Page
57
End Page
69
Journal / Book Title
Integrated Blood Pressure Control
Volume
2015
Issue
8
Copyright Statement
© 2015 Patel et al. This work is published by Dove Medical Press Limited, and licensed under Creative Commons Attribution – Non Commercial (unported, v3.0)
License. The full terms of the License are available at http://creativecommons.org/licenses/by-nc/3.0/. Non-commercial uses of the work are permitted without any further
permission from Dove Medical Press Limited, provided the work is properly attributed. Permissions beyond the scope of the License are administered by Dove Medical Press Limited. Information on
how to request permission may be found at: http://www.dovepress.com/permissions.php
License. The full terms of the License are available at http://creativecommons.org/licenses/by-nc/3.0/. Non-commercial uses of the work are permitted without any further
permission from Dove Medical Press Limited, provided the work is properly attributed. Permissions beyond the scope of the License are administered by Dove Medical Press Limited. Information on
how to request permission may be found at: http://www.dovepress.com/permissions.php
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Published