Hemodynamic-guided management using remote pulmonary artery pressure monitoring did not reduce mortality and total heart failure (HF) events in patients regardless of HF symptom severity compared with patients receiving usual care, according to GUIDE-HF findings presented during ESC Congress 2021 and simultaneously published in The Lancet. However, when adjusted for impacts of the COVID-19 pandemic, data did suggest a possible benefit in patients with chronic NYHA functional class II–IV HF and either a previous HF hospitalization or elevated natriuretic peptides.

Following successful implantation of a pulmonary artery pressure monitor, 1,000 patients with all ejection fractions, NYHA functional class II-IV HF, and either elevated natriuretic peptides or recent hospitalization for HF were randomly assigned to either hemodynamic-guided management or usual care. The primary endpoint was a composite of all-cause mortality and total HF events at 12 months. A COVID-19 sensitivity analysis was also conducted to compare events prior to and during the pandemic.

Overall results found no significant reduction in the cumulative incidence of primary endpoint events, which occurred in 253 of the 497 patients in the hemodynamic-guided group compared with 289 out of 503 patients in the usual care group. However, when adjusted for the COVID-19 pandemic, a significant decrease was observed in the pre-COVID-19 impact analysis, with 177 primary events occurring in the hemodynamic-guided groups compared with 224 events in patients receiving usual care. According to JoAnn Lindenfeld, MD, FACC, et al., "this difference in primary events almost disappeared during COVID-19, with a 21% decrease in the control group relative to pre-COVID-19, virtually no change in the treatment group, and no difference between groups."

"The findings indicate that the benefits of hemodynamic-guided management in reducing HF hospitalizations extend to patients with less severe HF (NYHA class II) and to those with NYHA II and III symptoms and elevated natriuretic peptides but no previous hospitalization," Lindenfeld said. "The NYHA class IV HF patients did not show consistent results but were small in number. The COVID-19 pandemic clearly affected the outcomes of GUIDE-HF, as it did the AFFIRM-AHF trial. Clinical trials conducted during pandemics will require statistical analysis plans to account for their effects."

Meanwhile, in a related editorial comment, John G. F. Cleland, MD, FACC, and Pierpaolo Pellicori, MD, write that GUIDE-HF findings "are encouraging but inconclusive." According to Cleland and Pellicori, the trial "did not enroll an ideal group of patients for showing the efficacy of pulmonary artery pressure monitoring, since many had baseline pressures in the target range with little possibility of short-term gain, follow-up was too short, and interventions did not substantially change pulmonary artery pressure." They suggest a large, simple, open-label trial "to investigate a system of care rather than a single technology" may be worthwhile.

Clinical Topics: COVID-19 Hub, Heart Failure and Cardiomyopathies, Noninvasive Imaging, Acute Heart Failure

Keywords: ESC Congress, ESC21, Heart Failure, Hemodynamics, Diagnostic Imaging, COVID-19, SARS-CoV-2

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