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Hemodynamic-Guided HF Management: GUIDE-HF Trial Analysis
Quick Takes
- For patients with symptomatic HF, there may be benefit from using hemodynamic data from wireless PAP sensors to guide management, both for patients with a recent HF hospitalization or elevated baseline natriuretic peptide levels without recent hospitalization.
- Despite lower event rates in patients with elevated natriuretic peptide levels but no recent HF hospitalization, treatment effects of a hemodynamic-guided approach were similar to patients with a recent HF hospitalization.
Study Questions:
Does the efficacy and safety of hemodynamic-guided heart failure (HF) management with a wireless pulmonary artery pressure (PAP) sensor differ based on enrollment criteria?
Methods:
This is an analysis of the GUIDE-HF (Hemodynamic-Guided Management of Heart Failure) trial, which enrolled 1,000 patients with HF experiencing New York Heart Association (NYHA) class II-IV symptoms and either a recent HF hospitalization (HFH) within 12 months or elevated natriuretic peptide (NP) levels. Patients were randomized to hemodynamic-guided HF management with a wireless PAP sensor or usual care. (The overall study showed no difference for the primary outcomes of all-cause mortality and total HF events; analysis of the pre–COVID-19 period suggested a possible benefit of hemodynamic-guided therapy in reducing HFHs).
In this analysis, patients were stratified based on enrollment criteria as either having a recent HFH (regardless of NP level) or elevated NP levels without a recent HFH. The primary outcome of this analysis was a composite of all-cause mortality and total HF events (hospitalizations and urgent ambulatory visits) at 12 months.
Results:
Of the 999 patients that could be stratified by enrollment criteria, 557 were enrolled with a recent HFH (regardless of NP level) and 442 were enrolled based on elevated NP levels alone. Compared to those with HFHs, patients enrolled based on NP alone tended to be older and more likely to identify as White, and in general have better functional capacity and fewer comorbidities. Compared to the HFH group, event rates were also significantly lower in the NP alone group (driven primarily by fewer HF events), in both the full study and the pre-COVID analysis.
For the pre-COVID cohort, the overall study suggested a possible benefit of hemodynamic-guided therapy in reducing the primary outcome and HFHs. This finding was consistent across the enrollment groups based on HFH (primary composite: hazard ratio [HR], 0.85; 95% confidence interval [CI], 0.66-1.08; HFH: HR, 0.73; 95% CI, 0.55-0.96) and elevated NP levels alone (primary composite: HR, 0.75; 95% CI, 0.51-1.13; HFH HR, 0.75; 95% CI, 0.47-1.20) (interaction p = 0.58). These findings we also consistent for the full study duration (interaction p = 0.71).
Conclusions:
The effect of hemodynamic-guided HF management compared to usual care was consistent across groups stratified by enrollment criteria (HFH vs. elevated NP levels).
Perspective:
The use of wireless PAP sensors to improve cardiovascular outcomes, in particular reducing HFHs, can be a powerful tool for selected patients. The GUIDE-HF trial sought to expand on the work of the CHAMPION-HF trial to include a broader group of HF patients, which included adding NP-based criteria for those without a recent hospitalization. While the results of the GUIDE-HF trial demonstrated no benefit, a COVID-19 analysis suggested possible confounding due to the pandemic and possible benefit when the pre-COVID period was assessed. Future studies will likely be needed to examine this issue further. However, it is reassuring that patients receiving a PAP sensor based on NP levels alone, despite likely having a lower risk profile without a recent hospitalization, had similar reductions in HF events and treatment benefits with a hemodynamic-guided HF management approach.
Clinical Topics: COVID-19 Hub, Heart Failure and Cardiomyopathies, Acute Heart Failure
Keywords: COVID-19, Heart Failure, Hemodynamics, Hospitalization, Natriuretic Peptides
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