Hemodynamic guided management reduces hospitalization due to early HF: Lancet

Published On 2021-09-25 05:00 GMT   |   Update On 2021-09-25 12:48 GMT

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. 

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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.

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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.

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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).

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• 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

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Article Source : The Lancet

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