Endovascular renal sympathetic denervation to improve heart failure with reduced ejection fraction: the IMPROVE-HF-I study.
Neth Heart J
; 30(3): 149-159, 2022 Mar.
Article
em En
| MEDLINE
| ID: mdl-34609726
ABSTRACT
INTRODUCTION:
The aim of the present study was to assess the safety and efficacy of renal sympathetic denervation (RDN) in patients with heart failure with reduced ejection fraction (HFrEF).METHODS:
We randomly assigned 50 patients with a left ventricular ejection fraction (LVEF) ≤â¯35% and NYHA class ≥â¯II, in a 11 ratio, to either RDN and optimal medical therapy (OMT) or OMT alone. The primary safety endpoint was the occurrence of a combined endpoint of cardiovascular death, rehospitalisation for heart failure, and acute kidney injury at 6 months. The primary efficacy endpoint was the change in iodine-123 meta-iodobenzylguanidine (123IMIBG) heart-to-mediastinum ratio (HMR) at 6 months.RESULTS:
Mean age was 60⯱ 9 years, 86% was male and mean LVEF was 33⯱ 8%. At 6 months, the primary safety endpoint occurred in 8.3% vs 8.0% in the RDN and OMT groups, respectively (pâ¯= 0.97). At 6 months, the mean change in late HMR was -0.02 (95% CI -0.08 to 0.12) in the RDN group, versus -0.02 (95% CI -0.09 to 0.12) in the OMT group (pâ¯= 0.95) whereas the mean change in washout rate was 2.34 (95% CI -6.35 to 1.67) in the RDN group versus -2.59 (95% CI -1.61 to 6.79) in the OMT group (p-value 0.09).CONCLUSION:
RDN with the Vessix system in patients with HFrEF was safe, but did not result in significant changes in cardiac sympathetic nerve activity at 6 months as measured using 123IMIBG.
Texto completo:
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Coleções:
01-internacional
Base de dados:
MEDLINE
Idioma:
En
Revista:
Neth Heart J
Ano de publicação:
2022
Tipo de documento:
Article
País de afiliação:
Holanda