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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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Detalles Bibliográficos
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
Descripción
Sumario: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.