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Effects of renal denervation on kidney function and long-term outcomes: 3-year follow-up from the Global SYMPLICITY Registry

AIMS: Several studies and registries have demonstrated sustained reductions in blood pressure (BP) after renal denervation (RDN). The long-term safety and efficacy after RDN in real-world patients with uncontrolled hypertension, however, remains unknown. The objective of this study was to assess the...

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Autores principales: Mahfoud, Felix, Böhm, Michael, Schmieder, Roland, Narkiewicz, Krzysztof, Ewen, Sebastian, Ruilope, Luis, Schlaich, Markus, Williams, Bryan, Fahy, Martin, Mancia, Giuseppe
Formato: Online Artículo Texto
Lenguaje:English
Publicado: Oxford University Press 2019
Materias:
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC6837160/
https://www.ncbi.nlm.nih.gov/pubmed/30907413
http://dx.doi.org/10.1093/eurheartj/ehz118
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author Mahfoud, Felix
Böhm, Michael
Schmieder, Roland
Narkiewicz, Krzysztof
Ewen, Sebastian
Ruilope, Luis
Schlaich, Markus
Williams, Bryan
Fahy, Martin
Mancia, Giuseppe
author_facet Mahfoud, Felix
Böhm, Michael
Schmieder, Roland
Narkiewicz, Krzysztof
Ewen, Sebastian
Ruilope, Luis
Schlaich, Markus
Williams, Bryan
Fahy, Martin
Mancia, Giuseppe
author_sort Mahfoud, Felix
collection PubMed
description AIMS: Several studies and registries have demonstrated sustained reductions in blood pressure (BP) after renal denervation (RDN). The long-term safety and efficacy after RDN in real-world patients with uncontrolled hypertension, however, remains unknown. The objective of this study was to assess the long-term safety and efficacy of RDN, including its effects on renal function. METHODS AND RESULTS: The Global SYMPLICITY Registry is a prospective, open-label registry conducted at 196 active sites worldwide in hypertensive patients receiving RDN treatment. Among 2237 patients enrolled and treated with the SYMPLICITY Flex catheter, 1742 were eligible for follow-up at 3 years. Baseline office and 24-h ambulatory systolic BP (SBP) were 166 ± 25 and 154 ± 18 mmHg, respectively. SBP reduction after RDN was sustained over 3 years, including decreases in both office (−16.5 ± 28.6 mmHg, P < 0.001) and 24-h ambulatory SBP (−8.0 ± 20.0 mmHg; P < 0.001). Twenty-one percent of patients had a baseline estimated glomerular filtration rate (eGFR) <60 mL/min/1.73 m(2). Between baseline and 3 years, renal function declined by 7.1 mL/min/1.73 m(2) in patients without chronic kidney disease (CKD; eGFR ≥60 mL/min/1.73 m(2); baseline eGFR 87 ± 17 mL/min/1.73 m(2)) and by 3.7 mL/min/1.73 m(2) in patients with CKD (eGFR <60 mL/min/1.73 m(2); baseline eGFR 47 ± 11 mL/min/1.73 m(2)). No long-term safety concerns were observed following the RDN procedure. CONCLUSION: Long-term data from the Global SYMPLICITY Registry representing the largest available cohort of hypertensive patients receiving RDN in a real-world clinical setting demonstrate both the safety and efficacy of the procedure with significant and sustained office and ambulatory BP reductions out to 3 years.
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spelling pubmed-68371602019-11-13 Effects of renal denervation on kidney function and long-term outcomes: 3-year follow-up from the Global SYMPLICITY Registry Mahfoud, Felix Böhm, Michael Schmieder, Roland Narkiewicz, Krzysztof Ewen, Sebastian Ruilope, Luis Schlaich, Markus Williams, Bryan Fahy, Martin Mancia, Giuseppe Eur Heart J Clinical Research AIMS: Several studies and registries have demonstrated sustained reductions in blood pressure (BP) after renal denervation (RDN). The long-term safety and efficacy after RDN in real-world patients with uncontrolled hypertension, however, remains unknown. The objective of this study was to assess the long-term safety and efficacy of RDN, including its effects on renal function. METHODS AND RESULTS: The Global SYMPLICITY Registry is a prospective, open-label registry conducted at 196 active sites worldwide in hypertensive patients receiving RDN treatment. Among 2237 patients enrolled and treated with the SYMPLICITY Flex catheter, 1742 were eligible for follow-up at 3 years. Baseline office and 24-h ambulatory systolic BP (SBP) were 166 ± 25 and 154 ± 18 mmHg, respectively. SBP reduction after RDN was sustained over 3 years, including decreases in both office (−16.5 ± 28.6 mmHg, P < 0.001) and 24-h ambulatory SBP (−8.0 ± 20.0 mmHg; P < 0.001). Twenty-one percent of patients had a baseline estimated glomerular filtration rate (eGFR) <60 mL/min/1.73 m(2). Between baseline and 3 years, renal function declined by 7.1 mL/min/1.73 m(2) in patients without chronic kidney disease (CKD; eGFR ≥60 mL/min/1.73 m(2); baseline eGFR 87 ± 17 mL/min/1.73 m(2)) and by 3.7 mL/min/1.73 m(2) in patients with CKD (eGFR <60 mL/min/1.73 m(2); baseline eGFR 47 ± 11 mL/min/1.73 m(2)). No long-term safety concerns were observed following the RDN procedure. CONCLUSION: Long-term data from the Global SYMPLICITY Registry representing the largest available cohort of hypertensive patients receiving RDN in a real-world clinical setting demonstrate both the safety and efficacy of the procedure with significant and sustained office and ambulatory BP reductions out to 3 years. Oxford University Press 2019-11-01 2019-03-25 /pmc/articles/PMC6837160/ /pubmed/30907413 http://dx.doi.org/10.1093/eurheartj/ehz118 Text en © The Author(s) 2019. Published by Oxford University Press on behalf of the European Society of Cardiology. http://creativecommons.org/licenses/by-nc/4.0/ This is an Open Access article distributed under the terms of the Creative Commons Attribution Non-Commercial License (http://creativecommons.org/licenses/by-nc/4.0/), which permits non-commercial re-use, distribution, and reproduction in any medium, provided the original work is properly cited. For commercial re-use, please contact journals.permissions@oup.com
spellingShingle Clinical Research
Mahfoud, Felix
Böhm, Michael
Schmieder, Roland
Narkiewicz, Krzysztof
Ewen, Sebastian
Ruilope, Luis
Schlaich, Markus
Williams, Bryan
Fahy, Martin
Mancia, Giuseppe
Effects of renal denervation on kidney function and long-term outcomes: 3-year follow-up from the Global SYMPLICITY Registry
title Effects of renal denervation on kidney function and long-term outcomes: 3-year follow-up from the Global SYMPLICITY Registry
title_full Effects of renal denervation on kidney function and long-term outcomes: 3-year follow-up from the Global SYMPLICITY Registry
title_fullStr Effects of renal denervation on kidney function and long-term outcomes: 3-year follow-up from the Global SYMPLICITY Registry
title_full_unstemmed Effects of renal denervation on kidney function and long-term outcomes: 3-year follow-up from the Global SYMPLICITY Registry
title_short Effects of renal denervation on kidney function and long-term outcomes: 3-year follow-up from the Global SYMPLICITY Registry
title_sort effects of renal denervation on kidney function and long-term outcomes: 3-year follow-up from the global symplicity registry
topic Clinical Research
url https://www.ncbi.nlm.nih.gov/pmc/articles/PMC6837160/
https://www.ncbi.nlm.nih.gov/pubmed/30907413
http://dx.doi.org/10.1093/eurheartj/ehz118
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