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

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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.

Supplementary Information

The online version of this article (10.1007/s12471-021-01633-z) contains supplementary material, which is available to authorized users.

Related collections

Most cited references 28

Record: found
Abstract: found
Article: not found

Empagliflozin, Cardiovascular Outcomes, and Mortality in Type 2 Diabetes.

Bernard Zinman, Christoph Wanner, John M. Lachin … (2015)

The effects of empagliflozin, an inhibitor of sodium-glucose cotransporter 2, in addition to standard care, on cardiovascular morbidity and mortality in patients with type 2 diabetes at high cardiovascular risk are not known.

0 comments Cited 2926 times – based on 0 reviews      Review now

Record: found
Abstract: found
Article: not found

Angiotensin–Neprilysin Inhibition versus Enalapril in Heart Failure

John J.V. McMurray, Milton Packer, Akshay S Desai … (2014)

We compared the angiotensin receptor-neprilysin inhibitor LCZ696 with enalapril in patients who had heart failure with a reduced ejection fraction. In previous studies, enalapril improved survival in such patients. In this double-blind trial, we randomly assigned 8442 patients with class II, III, or IV heart failure and an ejection fraction of 40% or less to receive either LCZ696 (at a dose of 200 mg twice daily) or enalapril (at a dose of 10 mg twice daily), in addition to recommended therapy. The primary outcome was a composite of death from cardiovascular causes or hospitalization for heart failure, but the trial was designed to detect a difference in the rates of death from cardiovascular causes. The trial was stopped early, according to prespecified rules, after a median follow-up of 27 months, because the boundary for an overwhelming benefit with LCZ696 had been crossed. At the time of study closure, the primary outcome had occurred in 914 patients (21.8%) in the LCZ696 group and 1117 patients (26.5%) in the enalapril group (hazard ratio in the LCZ696 group, 0.80; 95% confidence interval [CI], 0.73 to 0.87; P<0.001). A total of 711 patients (17.0%) receiving LCZ696 and 835 patients (19.8%) receiving enalapril died (hazard ratio for death from any cause, 0.84; 95% CI, 0.76 to 0.93; P<0.001); of these patients, 558 (13.3%) and 693 (16.5%), respectively, died from cardiovascular causes (hazard ratio, 0.80; 95% CI, 0.71 to 0.89; P<0.001). As compared with enalapril, LCZ696 also reduced the risk of hospitalization for heart failure by 21% (P<0.001) and decreased the symptoms and physical limitations of heart failure (P=0.001). The LCZ696 group had higher proportions of patients with hypotension and nonserious angioedema but lower proportions with renal impairment, hyperkalemia, and cough than the enalapril group. LCZ696 was superior to enalapril in reducing the risks of death and of hospitalization for heart failure. (Funded by Novartis; PARADIGM-HF ClinicalTrials.gov number, NCT01035255.).

0 comments Cited 1585 times – based on 0 reviews      Review now

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Abstract: found
Article: not found

Catheter-based renal sympathetic denervation for resistant hypertension: a multicentre safety and proof-of-principle cohort study.

Henry Krum, Markus Schlaich, Rob Whitbourn … (2009)

Renal sympathetic hyperactivity is associated with hypertension and its progression, chronic kidney disease, and heart failure. We did a proof-of-principle trial of therapeutic renal sympathetic denervation in patients with resistant hypertension (ie, systolic blood pressure >/=160 mm Hg on three or more antihypertensive medications, including a diuretic) to assess safety and blood-pressure reduction effectiveness. We enrolled 50 patients at five Australian and European centres; 5 patients were excluded for anatomical reasons (mainly on the basis of dual renal artery systems). Patients received percutaneous radiofrequency catheter-based treatment between June, 2007, and November, 2008, with subsequent follow-up to 1 year. We assessed the effectiveness of renal sympathetic denervation with renal noradrenaline spillover in a subgroup of patients. Primary endpoints were office blood pressure and safety data before and at 1, 3, 6, 9, and 12 months after procedure. Renal angiography was done before, immediately after, and 14-30 days after procedure, and magnetic resonance angiogram 6 months after procedure. We assessed blood-pressure lowering effectiveness by repeated measures ANOVA. This study is registered in Australia and Europe with ClinicalTrials.gov, numbers NCT 00483808 and NCT 00664638. In treated patients, baseline mean office blood pressure was 177/101 mm Hg (SD 20/15), (mean 4.7 antihypertensive medications); estimated glomerular filtration rate was 81 mL/min/1.73m(2) (SD 23); and mean reduction in renal noradrenaline spillover was 47% (95% CI 28-65%). Office blood pressures after procedure were reduced by -14/-10, -21/-10, -22/-11, -24/-11, and -27/-17 mm Hg at 1, 3, 6, 9, and 12 months, respectively. In the five non-treated patients, mean rise in office blood pressure was +3/-2, +2/+3, +14/+9, and +26/+17 mm Hg at 1, 3, 6, and 9 months, respectively. One intraprocedural renal artery dissection occurred before radiofrequency energy delivery, without further sequelae. There were no other renovascular complications. Catheter-based renal denervation causes substantial and sustained blood-pressure reduction, without serious adverse events, in patients with resistant hypertension. Prospective randomised clinical trials are needed to investigate the usefulness of this procedure in the management of this condition.

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Author and article information

Contributors

J. Daemen: j.daemen@erasmusmc.nl

Journal

Journal ID (nlm-ta): Neth Heart J

Journal ID (iso-abbrev): Neth Heart J

Title: Netherlands Heart Journal

Publisher: Bohn Stafleu van Loghum (Houten )

ISSN (Print): 1568-5888

ISSN (Electronic): 1876-6250

Publication date (Electronic): 5 October 2021

Publication date PMC-release: 5 October 2021

Publication date (Print): March 2022

Volume: 30

Issue: 3

Pages: 149-159

Affiliations

[1 ]GRID grid.5645.2, ISNI 000000040459992X, University Medical Center, Department of Cardiology, , Erasmus MC, ; Rotterdam, The Netherlands

[2 ]GRID grid.5645.2, ISNI 000000040459992X, Department of Radiology and Nuclear Medicine, , Erasmus MC, University Medical Center, ; Rotterdam, The Netherlands

[3 ]GRID grid.10417.33, ISNI 0000 0004 0444 9382, Department of Radiology and Nuclear Medicine, , Radboud University Medical Center, ; Nijmegen, The Netherlands

[4 ]GRID grid.461048.f, ISNI 0000 0004 0459 9858, Department of Cardiology, , Franciscus Gasthuis & Vlietland, ; Rotterdam, The Netherlands

Article

Publisher ID: 1633

DOI: 10.1007/s12471-021-01633-z

PMC ID: 8881518

PubMed ID: 34609726

SO-VID: 539efb99-4908-4b92-a735-f89f935c5004

License:

Open Access This article is licensed under a Creative Commons Attribution 4.0 International License, which permits use, sharing, adaptation, distribution and reproduction in any medium or format, as long as you give appropriate credit to the original author(s) and the source, provide a link to the Creative Commons licence, and indicate if changes were made. The images or other third party material in this article are included in the article’s Creative Commons licence, unless indicated otherwise in a credit line to the material. If material is not included in the article’s Creative Commons licence and your intended use is not permitted by statutory regulation or exceeds the permitted use, you will need to obtain permission directly from the copyright holder. To view a copy of this licence, visit http://creativecommons.org/licenses/by/4.0/.

History

Date accepted : 1 August 2021

Funding

Funded by: FundRef http://dx.doi.org/10.13039/100008497, Boston Scientific Corporation;

Custom metadata

ScienceOpen disciplines: Cardiovascular Medicine

Keywords: heart failure,iodine-123 meta-iodobenzylguanidine,sympathetic overactivity,renal sympathetic denervation

Data availability: