Hemodynamic guided management reduces hospitalization due to early HF: Lancet
USA: A recent study in the journal The Lancet showed that hemodynamic-guided management of heart failure did not lower mortality rates and total heart failure events compared to the control group. However, a pre-COVID-19 impact analysis suggested a possible benefit of hemodynamic-guided management in the pre-COVID-19 period on the primary outcome, driven primarily by a lower rate of heart failure hospitalization than the control group.
Prof JoAnn Lindenfeld, Vanderbilt Heart and Vascular Institute, Vanderbilt University Medical Center, Nashville, TN, USA, and colleagues aimed to evaluate whether hemodynamic-guided management using remote pulmonary artery pressure monitoring could reduce heart failure events and mortality in patients with heart failure across the spectrum of symptom severity (NYHA functional class II-IV), including those with elevated natriuretic peptides but without a recent heart failure hospitalization.
The study was designed as a randomized arm of the hemodynamic guided management of Heart Failure (GUIDE-HF) trial. It was a multicentre, single-blinded study conducted at 118 centers in the USA and Canada. Following successful implantation of a pulmonary artery pressure monitor, patients with all ejection fractions, NYHA functional class II-IV chronic heart failure, and either a recent heart failure hospitalization or elevated natriuretic peptides (based on a-priori thresholds) were considered and assigned (1:1) to either hemodynamic-guided heart failure management based on pulmonary artery pressure or a usual care control group. Patients were masked to their study group assignment. The primary endpoint was a composite of all-cause mortality and total heart failure events at 12 months assessed in all randomly assigned patients. Safety was assessed in all patients. Pre-COVID-19 impact analysis for the primary and secondary outcomes was prespecified.
The results of the study were
• Between March 15, 2018, and Dec 20, 2019, 1022 patients were enrolled, with 1000 patients implanted successfully, and follow-up was completed on Jan 8, 2021. There were 253 primary endpoint events (0•563 per patient-year) among 497 patients in the haemodynamic-guided management group (treatment group) and 289 (0•640 per patient-year) in 503 patients in the control group (hazard ratio [HR] 0•88, 95% CI 0•74–1•05; p=0•16).
• A prespecified COVID-19 sensitivity analysis was conducted using a time-dependent variable to compare events before COVID-19 and during the pandemic suggested a treatment interaction (pinteraction=0•11) due to a change in the primary endpoint event rate during the pandemic phase of the trial, warranting a pre-COVID-19 impact analysis.
• In the pre-COVID-19 impact analysis, there were 177 primary events (0•553 per patient-year) in the intervention group and 224 events (0•682 per patient-year) in the control group (HR 0•81, 95% CI 0•66–1•00; p=0•049).
• The cumulative incidence of heart failure events was not reduced by hemodynamic-guided management (0•85, 0•70–1•03; p=0•096) in the overall study analysis but was significantly decreased in the pre-COVID-19 impact analysis (0•76, 0•61–0•95; p=0•014). 1014 (99%) of 1022 patients had freedom from a device or system-related complications.
Lidenfeld and team concluded "Haemodynamic-guided management of heart failure did not result in a lower composite endpoint rate of mortality and total heart failure events compared with the control group in the overall study analysis. However, a pre-COVID-19 impact analysis indicated a possible benefit of hemodynamic-guided management on the primary outcome in the pre-COVID-19 period, primarily driven by a lower heart failure hospitalization rate compared with the control group."
For further information: https://doi.org/10.1016/S0140-6736(21)01754-2