Renal Denervation for Treating Hypertension: Current Scientific and Clinical Evidence

Michael A. Weber; Felix Mahfoud; Roland E. Schmieder; David E. Kandzari; Konstantinos P. Tsioufis; Raymond R. Townsend; Kazuomi Kario; Michael Böhm; Andrew S.P. Sharp; Justin E. Davies; John W. Osborn; Greg D. Fink; David E. Euler; Debbie L. Cohen; Markus P. Schlaich; Murray D. Esler

doi:10.1016/j.jcin.2019.02.050

Renal Denervation for Treating Hypertension: Current Scientific and Clinical Evidence

Michael A. Weber, Felix Mahfoud, Roland E. Schmieder, David E. Kandzari, Konstantinos P. Tsioufis, Raymond R. Townsend, Kazuomi Kario, Michael Böhm, Andrew S.P. Sharp, Justin E. Davies, John W. Osborn, Greg D. Fink, David E. Euler, Debbie L. Cohen, Markus P. Schlaich, Murray D. Esler

Surgery

Research output: Contribution to journal › Review article › peer-review

46 Scopus citations

Abstract

Initial studies of catheter-based renal denervation (RDN) for uncontrolled HTN using radiofrequency ablation in the main renal arteries showed that RDN was effective in lowering office blood pressure (BP). However, the first randomized sham-controlled trial, SYMPLICITY-HTN-3, did not show significantly lower office or 24-h ambulatory systolic BP compared with sham treatment. Subsequent studies in both animals and humans demonstrated the potential importance of more distal and branch renal artery radiofrequency ablation, and a second-generation multielectrode system became available. Two recent randomized sham-controlled trials in patients not taking antihypertensive drugs (SPYRAL HTN-OFF MED) or continuing to take drugs (SPYRAL HTN-ON MED) performed RDN with the second-generation radiofrequency ablation system using an ablation protocol that included treatment of the distal renal artery as well as the branch renal arteries. These studies showed that RDN significantly reduced office and 24-h ambulatory BP compared with sham treatment. Another recent randomized sham-controlled trial in patients not receiving medications showed that RDN with catheter-based ultrasound (RADIANCE-HTN SOLO) applied in just the main renal arteries significantly lowered daytime ambulatory and office BP compared with sham treatment. These trials have renewed clinical and scientific interest in defining the appropriate role of RDN in hypertension treatment. In addition, other important issues will need to be addressed in the future such as the development of tests to determine the extent of RDN at the time of the procedure and the potential of renal nerve fibers to regain their patency at some later stage following the ablation procedure.

Original language	English (US)
Pages (from-to)	1095-1105
Number of pages	11
Journal	JACC: Cardiovascular Interventions
Volume	12
Issue number	12
DOIs	https://doi.org/10.1016/j.jcin.2019.02.050
State	Published - Jun 24 2019

Bibliographical note

Funding Information:
Dr. Weber has received research or consultant fees from Medtronic, Boston Scientific, ReCor Medical, Ablative Solutions, and Sanofi, Johnson & Johnson. Dr. Mahfoud has received speaker honoraria and consultancy fees from St. Jude Medical, Medtronic, and ReCor Medical. Dr. Schmieder has received research funding, consultant fees, and travel support from ReCor Medical, Ablative Solutions, Pythagorus, Medtronic, and ROX Medical. Dr. Kandzari has received research or grant support from Medtronic and Ablative Solutions; and consulting honoraria from Medtronic. Dr. Tsioufis has received research support from Pythagoras Medical; and has received research support, consultant fees, and travel support from Medtronic, St. Jude Medical, Bayer, Novartis, AstraZeneca, Boehringer Ingelheim, Pfizer, Chiesi, Pharmanel, Sanofi, Vianex, WinMedica, ELPEN, Recordati, and Servier. Dr. Townsend has received research support and consultant fees from Medtronic. Dr. Kario has received research or consultant fees from Medtronic and Omron Healthcare. Dr. Böhm has received honoraria for lectures and scientific advice from Medtronic. Dr. Sharp has received research support and speaker fees from Medtronic; and has served as a consultant for Medtronic and ReCor Medical. Dr. Davies has received research support from Medtronic and Boston Scientific; and consulting fees from Medtronic and ReCor Medical. Dr. Osborn has received consulting fees and travel support from Medtronic; and served as a consultant for Neuromedic. Dr. Fink has received consulting fees and travel support from Medtronic. Dr. Euler has served as a consultant for Medtronic. Dr. Cohen has received research support and consultant fees from and served as a principal site investigator for Medtronic. Dr. Schlaich has received research funding, honoraria, and travel support from and served on the scientific advisory board for Medtronic. Dr. Esler has received research support and speaker fees, and has served on the scientific advisory board for Medtronic.

Publisher Copyright:
© 2019 American College of Cardiology Foundation

Keywords

ambulatory blood pressure
hypertension
radiofrequency
renal denervation
ultrasound

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10.1016/j.jcin.2019.02.050

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Weber, M. A., Mahfoud, F., Schmieder, R. E., Kandzari, D. E., Tsioufis, K. P., Townsend, R. R., Kario, K., Böhm, M., Sharp, A. S. P., Davies, J. E., Osborn, J. W., Fink, G. D., Euler, D. E., Cohen, D. L., Schlaich, M. P., & Esler, M. D. (2019). Renal Denervation for Treating Hypertension: Current Scientific and Clinical Evidence. JACC: Cardiovascular Interventions, 12(12), 1095-1105. https://doi.org/10.1016/j.jcin.2019.02.050

Weber, MA, Mahfoud, F, Schmieder, RE, Kandzari, DE, Tsioufis, KP, Townsend, RR, Kario, K, Böhm, M, Sharp, ASP, Davies, JE, Osborn, JW, Fink, GD, Euler, DE, Cohen, DL, Schlaich, MP & Esler, MD 2019, 'Renal Denervation for Treating Hypertension: Current Scientific and Clinical Evidence', JACC: Cardiovascular Interventions, vol. 12, no. 12, pp. 1095-1105. https://doi.org/10.1016/j.jcin.2019.02.050

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title = "Renal Denervation for Treating Hypertension: Current Scientific and Clinical Evidence",

abstract = "Initial studies of catheter-based renal denervation (RDN) for uncontrolled HTN using radiofrequency ablation in the main renal arteries showed that RDN was effective in lowering office blood pressure (BP). However, the first randomized sham-controlled trial, SYMPLICITY-HTN-3, did not show significantly lower office or 24-h ambulatory systolic BP compared with sham treatment. Subsequent studies in both animals and humans demonstrated the potential importance of more distal and branch renal artery radiofrequency ablation, and a second-generation multielectrode system became available. Two recent randomized sham-controlled trials in patients not taking antihypertensive drugs (SPYRAL HTN-OFF MED) or continuing to take drugs (SPYRAL HTN-ON MED) performed RDN with the second-generation radiofrequency ablation system using an ablation protocol that included treatment of the distal renal artery as well as the branch renal arteries. These studies showed that RDN significantly reduced office and 24-h ambulatory BP compared with sham treatment. Another recent randomized sham-controlled trial in patients not receiving medications showed that RDN with catheter-based ultrasound (RADIANCE-HTN SOLO) applied in just the main renal arteries significantly lowered daytime ambulatory and office BP compared with sham treatment. These trials have renewed clinical and scientific interest in defining the appropriate role of RDN in hypertension treatment. In addition, other important issues will need to be addressed in the future such as the development of tests to determine the extent of RDN at the time of the procedure and the potential of renal nerve fibers to regain their patency at some later stage following the ablation procedure.",

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author = "Weber, {Michael A.} and Felix Mahfoud and Schmieder, {Roland E.} and Kandzari, {David E.} and Tsioufis, {Konstantinos P.} and Townsend, {Raymond R.} and Kazuomi Kario and Michael B{\"o}hm and Sharp, {Andrew S.P.} and Davies, {Justin E.} and Osborn, {John W.} and Fink, {Greg D.} and Euler, {David E.} and Cohen, {Debbie L.} and Schlaich, {Markus P.} and Esler, {Murray D.}",

note = "Funding Information: Dr. Weber has received research or consultant fees from Medtronic, Boston Scientific, ReCor Medical, Ablative Solutions, and Sanofi, Johnson & Johnson. Dr. Mahfoud has received speaker honoraria and consultancy fees from St. Jude Medical, Medtronic, and ReCor Medical. Dr. Schmieder has received research funding, consultant fees, and travel support from ReCor Medical, Ablative Solutions, Pythagorus, Medtronic, and ROX Medical. Dr. Kandzari has received research or grant support from Medtronic and Ablative Solutions; and consulting honoraria from Medtronic. Dr. Tsioufis has received research support from Pythagoras Medical; and has received research support, consultant fees, and travel support from Medtronic, St. Jude Medical, Bayer, Novartis, AstraZeneca, Boehringer Ingelheim, Pfizer, Chiesi, Pharmanel, Sanofi, Vianex, WinMedica, ELPEN, Recordati, and Servier. Dr. Townsend has received research support and consultant fees from Medtronic. Dr. Kario has received research or consultant fees from Medtronic and Omron Healthcare. Dr. B{\"o}hm has received honoraria for lectures and scientific advice from Medtronic. Dr. Sharp has received research support and speaker fees from Medtronic; and has served as a consultant for Medtronic and ReCor Medical. Dr. Davies has received research support from Medtronic and Boston Scientific; and consulting fees from Medtronic and ReCor Medical. Dr. Osborn has received consulting fees and travel support from Medtronic; and served as a consultant for Neuromedic. Dr. Fink has received consulting fees and travel support from Medtronic. Dr. Euler has served as a consultant for Medtronic. Dr. Cohen has received research support and consultant fees from and served as a principal site investigator for Medtronic. Dr. Schlaich has received research funding, honoraria, and travel support from and served on the scientific advisory board for Medtronic. Dr. Esler has received research support and speaker fees, and has served on the scientific advisory board for Medtronic. Publisher Copyright: {\textcopyright} 2019 American College of Cardiology Foundation",

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doi = "10.1016/j.jcin.2019.02.050",

language = "English (US)",

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AU - Mahfoud, Felix

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AU - Kandzari, David E.

AU - Tsioufis, Konstantinos P.

AU - Townsend, Raymond R.

AU - Kario, Kazuomi

AU - Böhm, Michael

AU - Sharp, Andrew S.P.

AU - Davies, Justin E.

AU - Osborn, John W.

AU - Fink, Greg D.

AU - Euler, David E.

AU - Cohen, Debbie L.

AU - Schlaich, Markus P.

AU - Esler, Murray D.

N1 - Funding Information: Dr. Weber has received research or consultant fees from Medtronic, Boston Scientific, ReCor Medical, Ablative Solutions, and Sanofi, Johnson & Johnson. Dr. Mahfoud has received speaker honoraria and consultancy fees from St. Jude Medical, Medtronic, and ReCor Medical. Dr. Schmieder has received research funding, consultant fees, and travel support from ReCor Medical, Ablative Solutions, Pythagorus, Medtronic, and ROX Medical. Dr. Kandzari has received research or grant support from Medtronic and Ablative Solutions; and consulting honoraria from Medtronic. Dr. Tsioufis has received research support from Pythagoras Medical; and has received research support, consultant fees, and travel support from Medtronic, St. Jude Medical, Bayer, Novartis, AstraZeneca, Boehringer Ingelheim, Pfizer, Chiesi, Pharmanel, Sanofi, Vianex, WinMedica, ELPEN, Recordati, and Servier. Dr. Townsend has received research support and consultant fees from Medtronic. Dr. Kario has received research or consultant fees from Medtronic and Omron Healthcare. Dr. Böhm has received honoraria for lectures and scientific advice from Medtronic. Dr. Sharp has received research support and speaker fees from Medtronic; and has served as a consultant for Medtronic and ReCor Medical. Dr. Davies has received research support from Medtronic and Boston Scientific; and consulting fees from Medtronic and ReCor Medical. Dr. Osborn has received consulting fees and travel support from Medtronic; and served as a consultant for Neuromedic. Dr. Fink has received consulting fees and travel support from Medtronic. Dr. Euler has served as a consultant for Medtronic. Dr. Cohen has received research support and consultant fees from and served as a principal site investigator for Medtronic. Dr. Schlaich has received research funding, honoraria, and travel support from and served on the scientific advisory board for Medtronic. Dr. Esler has received research support and speaker fees, and has served on the scientific advisory board for Medtronic. Publisher Copyright: © 2019 American College of Cardiology Foundation

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N2 - Initial studies of catheter-based renal denervation (RDN) for uncontrolled HTN using radiofrequency ablation in the main renal arteries showed that RDN was effective in lowering office blood pressure (BP). However, the first randomized sham-controlled trial, SYMPLICITY-HTN-3, did not show significantly lower office or 24-h ambulatory systolic BP compared with sham treatment. Subsequent studies in both animals and humans demonstrated the potential importance of more distal and branch renal artery radiofrequency ablation, and a second-generation multielectrode system became available. Two recent randomized sham-controlled trials in patients not taking antihypertensive drugs (SPYRAL HTN-OFF MED) or continuing to take drugs (SPYRAL HTN-ON MED) performed RDN with the second-generation radiofrequency ablation system using an ablation protocol that included treatment of the distal renal artery as well as the branch renal arteries. These studies showed that RDN significantly reduced office and 24-h ambulatory BP compared with sham treatment. Another recent randomized sham-controlled trial in patients not receiving medications showed that RDN with catheter-based ultrasound (RADIANCE-HTN SOLO) applied in just the main renal arteries significantly lowered daytime ambulatory and office BP compared with sham treatment. These trials have renewed clinical and scientific interest in defining the appropriate role of RDN in hypertension treatment. In addition, other important issues will need to be addressed in the future such as the development of tests to determine the extent of RDN at the time of the procedure and the potential of renal nerve fibers to regain their patency at some later stage following the ablation procedure.

AB - Initial studies of catheter-based renal denervation (RDN) for uncontrolled HTN using radiofrequency ablation in the main renal arteries showed that RDN was effective in lowering office blood pressure (BP). However, the first randomized sham-controlled trial, SYMPLICITY-HTN-3, did not show significantly lower office or 24-h ambulatory systolic BP compared with sham treatment. Subsequent studies in both animals and humans demonstrated the potential importance of more distal and branch renal artery radiofrequency ablation, and a second-generation multielectrode system became available. Two recent randomized sham-controlled trials in patients not taking antihypertensive drugs (SPYRAL HTN-OFF MED) or continuing to take drugs (SPYRAL HTN-ON MED) performed RDN with the second-generation radiofrequency ablation system using an ablation protocol that included treatment of the distal renal artery as well as the branch renal arteries. These studies showed that RDN significantly reduced office and 24-h ambulatory BP compared with sham treatment. Another recent randomized sham-controlled trial in patients not receiving medications showed that RDN with catheter-based ultrasound (RADIANCE-HTN SOLO) applied in just the main renal arteries significantly lowered daytime ambulatory and office BP compared with sham treatment. These trials have renewed clinical and scientific interest in defining the appropriate role of RDN in hypertension treatment. In addition, other important issues will need to be addressed in the future such as the development of tests to determine the extent of RDN at the time of the procedure and the potential of renal nerve fibers to regain their patency at some later stage following the ablation procedure.

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Renal Denervation for Treating Hypertension: Current Scientific and Clinical Evidence

Abstract

Bibliographical note

Keywords

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