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New research presented in a Hot Line session today (27th August) at the ESC Congress 2021 has found that haemodynamic guided management may reduce heart failure hospitalisations in patients with earlier stage heart failure.
Although the observed reduction did not reach statistical significance in the overall analysis, it was statistically significant when limited to follow-up preceding the Covid-19 pandemic.
The GUIDE-HF trial enrolled 1,000 patients with New York Heart Association (NYHA) class II-IV heart failure and either a hospitalisation for heart failure within the preceding 12 months or elevated natriuretic peptide levels within 30 days prior to consent to participate in the study.
All participants underwent implantation of a CardioMEMS device – a wireless, battery-free sensor that is implanted into the pulmonary artery via a right heart catheterisation procedure to transmit pulmonary artery pressures.
Patients were then randomised 1:1 to haemodynamic guided management using transmitted pulmonary artery pressure or to a control group that did not have pulmonary artery pressures made available. Patients were blinded to the treatment allocation but the investigators were not blinded.
The cumulative incidence of HF events was significantly down in the pre-COVID-19 impact analysis
During a median follow-up of 11.7 months, 253 primary endpoint events (heart failure hospitalisations, urgent heart failure visits or mortality) occurred in the treatment group and 289 in the control group.
In the overall analysis, the primary endpoint was reduced by 12% in the treatment group but did not meet statistical significance, however, a prespecified Covid-19 impact analysis showed a significant interaction warranting a pre-Covid-19 analysis.
The pre-Covid-19 analysis assessed the primary endpoint up to 13 March 2020, the date of the national Covid emergency declaration in the US. The pre-Covid-19 analysis demonstrated a statistically significant 19% reduction in primary endpoint events in the treatment group.
Heart failure hospitalisations were reduced by 17% in the treatment group in the overall analysis (just missing statistical significance), but demonstrated a highly significant 28% reduction in the pre-Covid analysis.
Neither urgent heart failure visits nor mortality were reduced independently with treatment in the overall or pre-Covid-19 analyses.
“The Covid-19 pandemic clearly affected the outcomes of GUIDE-HF”
Principal investigator Professor JoAnn Lindenfeld of Vanderbilt University Medical Center, Nashville, US said: “The findings indicate that the benefits of haemodynamic guided management in reducing heart failure hospitalisations extend to patients with less severe heart failure (NYHA class II) and to those with NYHA II and III symptoms and elevated natriuretic peptides but no previous hospitalisation.
“The NYHA class IV heart failure 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.”