Abstract
IntroductionThe 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).MethodsWe randomly assigned 50 patients with a left ventricular ejection fraction (LVEF) ≤ 35% and NYHA class ≥ II, in a 1:1 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 (123I‑MIBG) heart-to-mediastinum ratio (HMR) at 6 months.ResultsMean 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 (p = 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 (p = 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).ConclusionRDN 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 123I‑MIBG.Supplementary InformationThe online version of this article (10.1007/s12471-021-01633-z) contains supplementary material, which is available to authorized users.
Highlights
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)
While pharmacological treatment for heart failure with reduced ejection fraction (HFrEF) has shown to prevent hospitalisation and improve quality of life and survival, its long-term prognosis remains poor justifying a persistent need for novel therapeutic strategies that improve both morbidity and mortality [2,3,4,5,6]
Patients were eligible for enrolment when the following inclusion criteria were met: left ventricular ejection fraction (LVEF) ≤ 35%, New York Heart Association (NYHA) functional class ≥ II, age between 18 and 75 years, renal arteries suitable for RDN, a glomerular filtration rate of > 30 ml/min/1.73 m2
Summary
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). The primary efficacy endpoint was the change in iodine123 meta-iodobenzylguanidine (123I-MIBG) heart-tomediastinum ratio (HMR) at 6 months. Renal sympathetic denervation (RDN) emerged as a novel minimally invasive treatment option to reduce sympathetic tone and proved to significantly reduce blood pressure in hypertensive patients [11,12,13,14]. In contrast to several studies with pharmaceutical agents, data correlating the effect of RDN on cardiac sympathetic tone as measured using iodine123 labelled meta-iodobenzylguanidine (123I-MIBG) is lacking. The present study aimed to assess the safety and efficacy of RDN in patients with HFrEF as measured using 123I-MIBG at 6 months
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