Effects of renal denervation on kidney function and long-term outcomes: 3-year follow-up from the Global SYMPLICITY Registry
Mahfoud F, Böhm M, Schmieder R, Narkiewicz K, Ewen S, Ruilope L, Schlaich M, Williams B, Fahy M, Mancia G (2019)
Publication Type: Journal article
Publication year: 2019
Journal
Book Volume: 40
Pages Range: 3474-3482
Journal Issue: 42
Abstract
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 m2. Between baseline and 3 years, renal function declined by 7.1 mL/min/1.73 m2 in patients without chronic kidney disease (CKD; eGFR ≥60 mL/min/1.73 m2; baseline eGFR 87 ± 17 mL/min/1.73 m2) and by 3.7 mL/min/1.73 m2 in patients with CKD (eGFR <60 mL/min/1.73 m2; baseline eGFR 47 ± 11 mL/min/1.73 m2). 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.
Authors with CRIS profile
Involved external institutions
Universitätsklinikum des Saarlandes (UKS)
Germany (DE)
Medical University Gdansk / Gdański Uniwersytet Medyczny
Poland (PL)
Hospital Universitario 12 de Octubre
Spain (ES)
University of Western Australia (UWA)
Australia (AU)
University College London (UCL)
United Kingdom (GB)
Medtronic
United States (USA) (US)
University of Milano-Bicocca / Università degli Studi di Milano-Bicocca, UNIMIB
Italy (IT)
Germany (DE)
Medical University Gdansk / Gdański Uniwersytet Medyczny
Poland (PL)
Hospital Universitario 12 de Octubre
Spain (ES)
University of Western Australia (UWA)
Australia (AU)
University College London (UCL)
United Kingdom (GB)
Medtronic
United States (USA) (US)
University of Milano-Bicocca / Università degli Studi di Milano-Bicocca, UNIMIB
Italy (IT)
How to cite
APA:
Mahfoud, F., Böhm, M., Schmieder, R., Narkiewicz, K., Ewen, S., Ruilope, L.,... Mancia, G. (2019). Effects of renal denervation on kidney function and long-term outcomes: 3-year follow-up from the Global SYMPLICITY Registry. European Heart Journal, 40(42), 3474-3482. https://doi.org/10.1093/eurheartj/ehz118
MLA:
Mahfoud, Felix, et al. "Effects of renal denervation on kidney function and long-term outcomes: 3-year follow-up from the Global SYMPLICITY Registry." European Heart Journal 40.42 (2019): 3474-3482.
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