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SHR Neuro Cancer Cardio Lipid Metab Microb
Böhm, M; Mahfoud, F; Ukena, C; Hoppe, UC; Narkiewicz, K; Negoita, M; Ruilope, L; Schlaich, MP; Schmieder, RE; Whitbourn, R; Williams, B; Zeymer, U; Zirlik, A; Mancia, G; GSR Investigators.
First report of the Global SYMPLICITY Registry on the effect of renal artery denervation in patients with uncontrolled hypertension.
HYPERTENSION. 2015; 65(4): 766-774.
Doi: 10.1161/HYPERTENSIONAHA.114.05010
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- Co-authors Med Uni Graz
- Zirlik Andreas
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- Abstract:
- This study aimed to assess the safety and effectiveness of renal denervation using the Symplicity system in real-world patients with uncontrolled hypertension (NCT01534299). The Global SYMPLICITY Registry is a prospective, open-label, multicenter registry. Office and 24-hour ambulatory blood pressures (BPs) were measured. Change from baseline to 6 months was analyzed for all patients and for subgroups based on baseline office systolic BP, diabetic status, and renal function; a cohort with severe hypertension (office systolic pressure, ≥160 mm Hg; 24-hour systolic pressure, ≥135 mm Hg; and ≥3 antihypertensive medication classes) was also included. The analysis included protocol-defined safety events. Six-month outcomes for 998 patients, including 323 in the severe hypertension cohort, are reported. Mean baseline office systolic BP was 163.5±24.0 mm Hg for all patients and 179.3±16.5 mm Hg for the severe cohort; the corresponding baseline 24-hour mean systolic BPs were 151.5±17.0 and 159.0±15.6 mm Hg. At 6 months, the changes in office and 24-hour systolic BPs were -11.6±25.3 and -6.6±18.0 mm Hg for all patients (P<0.001 for both) and -20.3±22.8 and -8.9±16.9 mm Hg for those with severe hypertension (P<0.001 for both). Renal denervation was associated with low rates of adverse events. After the procedure through 6 months, there was 1 new renal artery stenosis >70% and 5 cases of hospitalization for a hypertensive emergency. In clinical practice, renal denervation resulted in significant reductions in office and 24-hour BPs with a favorable safety profile. Greater BP-lowering effects occurred in patients with higher baseline pressures. URL: www.clinicaltrials.gov. Unique identifier: NCT01534299. © 2015 American Heart Association, Inc.
- Find related publications in this database (using NLM MeSH Indexing)
- Blood Pressure - physiology
- Blood Pressure Monitoring, Ambulatory -
- Female -
- Follow-Up Studies -
- Humans -
- Hypertension - physiopathology
- Hypertension - surgery
- Male -
- Middle Aged -
- Prospective Studies -
- Registries -
- Renal Artery - innervation
- Sympathectomy - methods
- Sympathetic Nervous System - physiopathology
- Sympathetic Nervous System - surgery
- Time Factors -
- Treatment Outcome -
- Find related publications in this database (Keywords)
- denervation
- hypertension
- sympathetic nervous system