Hemodynamic-guided management of heart failure (HF) may not correlate with lower composite mortality or total HF events compared with controls, according to a study recently published in The Lancet. The study did find, however, a potential benefit with hemodynamic-guided management on all-cause mortality and total heart failure events in the time period prior to the COVID-19 pandemic, possibly driven by lower HF hospitalization rates.
This multicenter study was an arm of the haemodynamic-GUIDEd management of Heart Failure (GUIDE-HF) trial, conducted at 118 trial sites in Canada and the United States. It included 1000 individuals with New York Heart Association (NYHA) functional class II-IV HF, irrespective of left ventricular ejection fraction, all of whom either were hospitalized for HF within 1 year of study consent or who demonstrated elevated natriuretic peptides within 1 month of study consent.
Participants were randomly assigned to the treatment (n=497) or control (n=503) group, and were blind to their assignment. Treatment included pulmonary artery pressure-guided HF management, while the control group received conventional care; the study researchers were aware of group assignment but could not access participants’ pulmonary artery pressure data in the control group. The study’s composite primary endpoint was total HF events and all-cause mortality at 12 months. Participant safety was assessed.
Among the treatment group (n=497), there were 253 primary endpoint events vs 289 events in the control group (n=503; hazard ratio [HR], 0.88; 95% CI, 0.74-1.05; P =.16). The study researchers performed a sensitivity analysis comparing events before and during the COVID-19 pandemic; their results suggested the primary endpoint event rate had changed since the pandemic began (Pinteraction =.11).
In the pre-COVID portion of the trial, the treatment group experienced 177 primary events vs 224 in the control group (HR, 0.81; 95% CI, 0.66-1.00; P =.049); this intergroup difference disappeared during the pandemic (P =.53).
Though hemodynamic-guided management was not associated with decreased HF events in the overall study (HR, 0.85; 95% CI, 0.70-1.03; P =.096), there was a significant decrease during the pre-COVID portion of the study (HR 0.76; 95% CI, 0.61-0.95; P =.014).
Limitations to this study included masking participants to their assigned treatment, a 12-month follow-up duration, and limited data collection due to the COVID-19 pandemic.
The results of the overall study analysis did not find any clinical benefits with guided management on the primary outcomes. Analysis of the pre-COVID-19 impact did suggest there was a net benefit on heart failure outcomes.
“The results of the GUIDE-HF trial, when adjusted for the effects of the COVID-19 pandemic, support the recommendation for [hemodynamic]-guided management using a pulmonary artery pressure sensor in patients with chronic NYHA functional class II–IV heart failure and either a previous heart failure [hospitalization] or elevated natriuretic peptide,” the study authors concluded.
This study was supported by Abbott. Please refer to the reference for a complete list of authors’ disclosures.
Lindenfeld J, Zile MR, Desai AS, et al. Haemodynamic-guided management of heart failure (GUIDE-HF): a randomised controlled trial. Lancet. 2021;398(10304):991-1001.