- Question
- Can management guided by daily pulmonary artery pressure measured with an implantable wireless sensor reduce heart failure hospitalisations compared with standard care?
- Design
- Randomised, single-blind trial (only patients were masked) with allocation by a centralised electronic system, conducted at 64 centres in the USA. A total of 550 patients were randomised and follow-up was at least 6 months (mean 15 months over the entire period).
- Population
- Patients with NYHA class III heart failure, regardless of left ventricular ejection fraction, and a previous hospital admission for heart failure.
- Intervention
- Management with the wireless implantable haemodynamic monitoring system: clinicians used daily pulmonary artery pressure measurements in addition to standard of care.
- Control
- Standard heart failure care alone (control group).
- Primary outcome
- Rate of heart-failure-related hospitalisations at 6 months. Safety endpoints at 6 months were freedom from device- or system-related complications and freedom from pressure-sensor failures.
- Results
- At 6 months there were 83 heart-failure-related hospitalisations in the treatment group (n=270) versus 120 in the control group (n=280); rate 0.31 vs 0.44, HR 0.70 (95% CI 0.60-0.84; p<0.0001). Over the entire follow-up the treatment group had a 39% reduction (153 vs 253 hospitalisations; HR 0.64, 95% CI 0.55-0.75; p<0.0001).
- Safety
- Eight patients had device- or system-related complications; freedom from these was 98.6% (95% CI 97.3-99.4), versus a prespecified performance criterion of 80%. Freedom from pressure-sensor failure was 100%.
- Conclusion
- Management guided by wireless pulmonary artery pressure monitoring significantly reduced heart failure hospitalisations in NYHA class III patients, with a favourable safety profile.
- Why it matters
- It showed that adding haemodynamic information to clinical signs and symptoms allows more effective heart failure management and laid the groundwork for implantable remote haemodynamic monitoring as a strategy to reduce hospital admissions.
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 14, 2026