Heart failure & cardiomyopathiesCohort study
Mechanically Reducing Cardiac Preload With the preCARDIA System in Acutely Decompensated Heart Failure
- Early feasibility study (single-arm)
- multicenter
- prospective
Authors' conclusion
Use of the preCARDIA system in patients with ADHF was feasible and well tolerated, with early exploratory signals of significantly reduced cardiac filling pressures and increased urine output.
Study context
- Population
- Patients with acute decompensated heart failure (ADHF)
- Participants
- 60 patients
- Outcome
- Safety and technical feasibility of the device
Main finding
As reported in the abstract
Freedom from device- or procedure-related major adverse events
98.3% (n = 59/60)
Successful device deployment and removal
all subjects (N = 60)
Observational data: associations, not effects.
Secondary outcomes
Right atrial pressure, baseline vs end of device use (subjects with 24 ± 3 h use)
- Decreased by 23% (18 ± 6 vs 11 ± 6 mm Hg)
- P < 0.0001
- n = 52
Pulmonary capillary wedge pressure, baseline vs end of device use (subjects with 24 ± 3 h use)
- Decreased by 18% (30 ± 8 vs 24 ± 9 mm Hg)
- P < 0.0001
- n = 52
Net urine output, 24 h before vs 24 h during device use · up to 24 hours
- Net urine output increased (−1.5 ± 0.9 vs −3.4 ± 2.4 L)
- P < 0.001
Safety
Major adverse events, original vs newest generation device
Major adverse events, original vs newest generation device
- No statistically significant difference
Original publication
Summarised from the published abstract; every number is checked against it