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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...
Autores principales: | , , , , , , , , , |
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Formato: | Online Artículo Texto |
Lenguaje: | English |
Publicado: |
Oxford University Press
2019
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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. |
format | Online Article Text |
id | pubmed-6837160 |
institution | National Center for Biotechnology Information |
language | English |
publishDate | 2019 |
publisher | Oxford University Press |
record_format | MEDLINE/PubMed |
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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