The GUIDE-HF trial, presented in a Hot Line Session and simultaneously published in The Lancet, showed benefits of hemodynamic-guided heart failure (HF) management with an implantable device in reducing HF hospitalization [1,2]. However, no influence was observed on urgent HF visits and mortality.
The rationale of hemodynamic-guided HF management is that the addition of information about pulmonary artery pressure to clinical signs and symptoms may allow for improved HF management as elevated or increasing pulmonary artery pressure predicts congestion. The single-blind prospective GUIDE-HF (NCT03387813) trial, presented by Prof. JoAnn Lindenfeld (Vanderbilt University Medical Center, TN, USA), assessed this approach in 1,022 patients with NYHA class II–IV HF and either a hospitalization for HF within the preceding 12 months or elevated natriuretic peptides (i.e. B-type natriuretic peptide/N-terminal pro-B-type natriuretic peptide) within 30 days.
All participants underwent implantation of the wireless hemodynamic monitoring device (CardioMEMS). Patients were then randomized 1:1 to either a treatment group, managed with provider remote access to the hemodynamic data, or a control group, managed without provider access to these data. The primary endpoint was a composite of cumulative HF hospitalizations, urgent HF visits, and mortality during a median follow-up of 11.7 months. There were 253 primary endpoint events among 497 patients in the hemodynamic-guided management group and 289 in 503 patients in the control group. In the overall analysis, the primary endpoint was reduced by 12% in the treatment group. This difference failed to meet statistical significance (HR 0.88; 95% CI 0.74–1.05; P=0.16).
Interestingly, a pre-specified COVID-19 sensitivity analysis including the primary endpoint up to 13 March 2020, the date of the national COVID emergency declaration in the US, showed a different result: 177 primary events occurred in the intervention group and 224 events in the control group. This translated in a significant 19% reduction in primary endpoint events in the treatment group (HR 0.81; CI 0.66–1.00; P=0.049). 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 (HR 1.11; 95% CI 0.80–1.55; P=0.53). Again, HF hospitalizations were not reduced by hemodynamic-guided management (HR 0.83; 95% CI 0.68–1.01; P=0.064) in the overall study analysis but were significantly decreased in the pre-COVID-19 impact analysis by 28% (HR 0.72; 95% CI 0.57–0.92; P=0.007). Neither urgent HF visits nor mortality were reduced independently with treatment in the overall or pre-COVID-19 analyses. “This was a very safe device,” Prof. Lindenfeld said. Of the 1,022 participants, 1,014 (99%) had freedom from device or system-related complications.
“The results suggest that the benefits of hemodynamic-guided management in reducing HF hospitalizations extend to patients with NYHA class II symptoms and to those with elevated natriuretic peptides, independent of prior HF hospitalizations in all ejection fractions. The COVID-19 pandemic clearly affected the outcomes of GUIDE-HF,” Prof. Lindenfeld concluded.
- Lindenfeld J. GUIDE-HF: hemodynamic-guided management of heart failure – randomized arm primary outcomes. Hot Line Session, ESC Congress, 27–30 August.
- Lindenfeld J, et al. Lancet 2021; August 27, 2021. DOI: 10.1016/S0140-6736(21)01754-2