Heart failure (HF) management remains a significant clinical challenge, particularly given the diverse patient population and varying degrees of left ventricular ejection fraction (EF). A recent study, the GUIDE-HF trial, investigated the effectiveness of hemodynamically-guided management using an implanted pulmonary artery pressure sensor across this spectrum of patients. This approach is indicated for reducing HF hospitalizations in New York Heart Association (NYHA) functional class II-III patients with a history of HF hospitalization or elevated natriuretic peptides.
Study Design and Objectives
The GUIDE-HF trial was a randomized study involving 1,000 NYHA functional class II-IV patients who had either been hospitalized for HF within the previous year or presented with elevated natriuretic peptides, adjusted for EF and body mass index. Participants were implanted with a pulmonary artery pressure sensor and then randomized in a 1:1 ratio to either a hemodynamically-guided management group (treatment) or a control group receiving standard care. The primary endpoint was a composite of HF hospitalizations, urgent HF visits, and all-cause mortality assessed over 12 months. The trial specifically aimed to evaluate how left ventricular ejection fraction (EF) impacts treatment outcomes within guideline-defined subgroups: ≤40%, 41%-49%, and ≥50%. This analysis focused on the pre-COVID-19 period cohort as specified in the trial protocol.
Key Findings Across the Ejection Fraction Spectrum
The results of the GUIDE-HF trial demonstrated a significant benefit from hemodynamically-guided management. Across the entire study population, the treatment group experienced 177 primary events (0.553/patient-year) compared to 224 events (0.682/patient-year) in the control group (HR: 0.81 [95% CI: 0.66-1.00]; P = 0.049). Notably, HF hospitalization rates were significantly lower in the treatment group (HR: 0.72 [95% CI: 0.57-0.92]; P = 0.0072). Crucially, when outcomes were analyzed within each EF subgroup, the benefits of hemodynamically-guided management were consistent. In all EF subgroups (≤40%, 41%-49%, and ≥50%), both the primary endpoint rates and HF hospitalization rates were lower in the treatment group, with hazard ratios consistently below 1.0. The reduction in event rates observed in the treatment groups across the EF spectrum was correlated with reductions in pulmonary artery pressures and guideline-recommended medication adjustments.
Implications and Conclusion
The GUIDE-HF trial provides compelling evidence that hemodynamically-guided heart failure management is effective in reducing HF-related endpoints across the spectrum of ejection fraction in a broad HF patient population. This includes patients with both reduced and preserved ejection fraction, expanding the applicability of this management strategy. The findings underscore the value of pulmonary artery pressure monitoring to optimize heart failure care and improve patient outcomes, irrespective of EF. The consistent benefit observed across the EF spectrum highlights the potential of this approach to personalize and enhance heart failure management for a wider range of patients.
(Hemodynamic-GUIDEd Management of Heart Failure [GUIDE-HF]; NCT03387813)
