Elsevier

JACC: Heart Failure

Volume 10, Issue 12, December 2022, Pages 931-944
JACC: Heart Failure

Clinical Research
Hemodynamically-Guided Management of Heart Failure Across the Ejection Fraction Spectrum: The GUIDE-HF Trial

https://doi.org/10.1016/j.jchf.2022.08.012Get rights and content
Under a Creative Commons license
open access

Abstract

Background

Hemodynamically-guided management using an implanted pulmonary artery pressure sensor is indicated to reduce heart failure (HF) hospitalizations in patients with New York Heart Association (NYHA) functional class II-III with a prior HF hospitalization or those with elevated natriuretic peptides.

Objectives

The authors sought to evaluate the effect of left ventricular ejection fraction (EF) on treatment outcomes in the GUIDE-HF (Hemodynamic-GUIDEd management of Heart Failure) randomized trial.

Methods

The GUIDE-HF randomized arm included 1,000 NYHA functional class II-IV patients (with HF hospitalization within the prior 12 months or elevated natriuretic peptides adjusted for EF and body mass index) implanted with a pulmonary artery pressure sensor, randomized 1:1 to a hemodynamically-guided management group (treatment) or a control group (control). The primary endpoint was the composite of HF hospitalizations, urgent HF visits, and all-cause mortality at 12 months. The authors assessed outcomes by EF in guideline-defined subgroups ≤40%, 41%-49%, and ≥50%, within the trial specified pre–COVID-19 period cohort.

Results

There were 177 primary events (0.553/patient-year) in the treatment group and 224 events (0.682/patient-year) in the control group (HR: 0.81 [95% CI: 0.66-1.00]; P = 0.049); HF hospitalization was lower in the treatment vs control group (HR: 0.72 [95% CI: 0.57-0.92]; P = 0.0072). Within each EF subgroup, primary endpoint and HF hospitalization rates were lower in the treatment group (HR <1.0 across the EF spectrum). Event rate reduction by EF in the treatment groups was correlated with reduction in pulmonary artery pressures and medication changes.

Conclusions

Hemodynamically-guided HF management decreases HF-related endpoints across the EF spectrum in an expanded patient population of patients with HF. (Hemodynamic-GUIDEd Management of Heart Failure [GUIDE-HF]; NCT03387813)

Key Words

ejection fraction
heart failure
hemodynamics
pulmonary artery pressure

Abbreviations and Acronyms

ACE
angiotensin-converting enzyme
AE
adverse event
ARB
angiotensin receptor blocker
ARNI
angiotensin receptor blocker-neprilysin inhibitor
EF
ejection fraction
FDA
Food and Drug Administration
HF
heart failure
HFmrEF
heart failure with mildly reduced ejection fraction
HFpEF
heart failure with preserved ejection fraction
HFrEF
heart failure with reduced ejection fraction
MRA
mineralocorticoid receptor antagonist
NYHA
New York Heart Association
PA
pulmonary artery
SAP
statistical analysis plan
SGLT2
sodium-glucose transport protein 2

Cited by (0)

G. Michael Felker, MD, served as Guest Associate Editor for this paper. Barry Greenberg, MD, served as Guest Editor-in-Chief for this paper.

The authors attest they are in compliance with human studies committees and animal welfare regulations of the authors’ institutions and Food and Drug Administration guidelines, including patient consent where appropriate. For more information, visit the Author Center.