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. 2022 Mar;30(3):149-159.
doi: 10.1007/s12471-021-01633-z. Epub 2021 Oct 5.

Endovascular renal sympathetic denervation to improve heart failure with reduced ejection fraction: the IMPROVE-HF-I study

L Feyz  1 , R Nannan Panday  1 , M Henneman  2 , F Verzijlbergen  2   3 , A A Constantinescu  1 , B M van Dalen  1   4 , J J Brugts  1 , K Caliskan  1 , M L Geleijnse  1 , I Kardys  1 , N M Van Mieghem  1 , O Manintveld  1 , J Daemen  5
Affiliations

Endovascular renal sympathetic denervation to improve heart failure with reduced ejection fraction: the IMPROVE-HF-I study

L Feyz et al. Neth Heart J. 2022 Mar.

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) ≤ 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.

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 (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).

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 123I‑MIBG.

Keywords: Heart failure; Iodine-123 meta-iodobenzylguanidine; Renal sympathetic denervation; Sympathetic overactivity.

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Conflict of interest statement

J. Daemen received institutional grant/research support from Abbott Vascular, Biotronik, Boston Scientific, Acist Medical, Medtronic and PulseCath, and consultancy and speaker fees from Acist medical, Boston Scientific, ReCor Medical, Medtronic and Pulse Cath. N.M. Van Mieghem received institutional grant/research support from Abbott Vascular, Boston Scientific, Medtronic, Edwards Lifesciences, Biotronik, ACIST Medical, PulseCath and is advisor/consultant to Abbott Vascular, Boston Scientific, Medtronic, PulseCath. L. Feyz, R. Nannan Panday, M. Henneman, F. Verzijlbergen, A.A. Constantinescu, B.M. van Dalen, J.J. Brugts, K. Caliskan, M.L. Geleijnse, I. Kardys, and O. Manintveld declare that they have no competing interests.

Figures

Fig. 1
Fig. 1
Patients screened for eligibility, *Other = participation in other research studies (N = 9), waiting for heart transplantation (N = 14), refused consent, due to study burden, (N = 31) or other reasons (N = 60), non-compliance (N = 5), distance to the hospital (N = 6), not yet on OMT (N = 23), unable to contact (N = 24). **Lost-to-follow-up (in the OMT-group) N = 1: patient retracted informed consent, still alive at 6 months. ABPM ambulatory blood pressure measurement, eGFR estimated glomerular filtration rate, LVAD left ventricular assist device, LVEF left ventricular ejection fraction, MIBG meta-iodobenzylguanidine, NYHA New York Heart Association, OMT optimal medical therapy, RDN renal sympathetic denervation, SBP systolic blood pressure, 6M 6 months
See this image and copyright information in PMC

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