- Question
- To assess whether haemodynamic-guided heart failure management using a remote pulmonary artery pressure monitor reduces mortality and heart failure events across a range of symptom severity, including patients with elevated natriuretic peptides but no recent hospitalisation.
- Design
- Randomised (1:1), multicentre, single-blind trial (patients masked to assignment) at 118 centres in the USA and Canada. A total of 1000 patients with a successfully implanted monitor were randomised; investigators had no access to pressure data for control patients.
- Population
- Patients with chronic heart failure, NYHA class II-IV, any ejection fraction, with either a recent heart failure hospitalisation or elevated natriuretic peptides based on prespecified thresholds.
- Intervention
- Heart failure management guided by pulmonary artery pressure data from the implanted sensor.
- Control
- Usual care, with the sensor implanted but without the treating team having access to pressure data.
- Primary outcome
- Composite of all-cause mortality and total heart failure events (heart failure hospitalisations and urgent heart failure visits) at 12 months.
- Results
- There were 253 primary events (0.563 per patient-year) in the guided group and 289 (0.640 per patient-year) in the control group (HR 0.88; 95% CI 0.74-1.05; p=0.16), with no significant difference in the overall analysis. In the prespecified pre-COVID-19 impact analysis the HR was 0.81 (95% CI 0.66-1.00; p=0.049), whereas during the pandemic there was no difference (HR 1.11; 95% CI 0.80-1.55; p=0.53).
- Safety
- 99% of patients (1014 of 1022) were free from device- or system-related complications.
- Conclusion
- Haemodynamic-guided management did not reduce the composite of mortality and heart failure events in the overall analysis, although the pre-COVID-19 analysis suggested a possible benefit driven by fewer hospitalisations.
- Why it matters
- It raised doubts about the benefit of pulmonary artery pressure monitoring in a broader spectrum of heart failure patients and showed how the pandemic may have altered a trial's results, so its findings are interpreted with caution.
Card generated automatically with AI from the abstract of the original publication and the trial registry; every figure was checked against those sources. It may contain errors: verify the data at the source before using it for clinical decisions.
Generated on October 18, 2026