Safety, usability, and performance of a wireless left atrial pressure monitoring system in patients with heart failure: the VECTOR-HF trial (final results)
Key result
V-LAP monitoring proves safe in heart failure with 97% freedom from MACNE and good PCWP correlation.
- LCCC 0.776
- 95% CI 0.582-0.886
- P<0.0001
- n=30
Why the study?
Direct left-sided hemodynamic sensors offer theoretical benefits beyond pulmonary artery pressure monitoring systems, but the safety, usability, and performance of a novel left atrial pressure monitoring system in HF patients needed evaluation.
Is the V-LAP wireless left atrial pressure monitoring system safe and accurate in patients with heart failure?
Population
30 patients with HF
Comparison
V-LAP interatrial leadless sensor monitoring system implantation
Design
First-in-human prospective multicenter single-arm clinical trial
Authors
Discussion
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Member takes
Key expert perspectives
Captured external expert commentary on this paper, strongest first. Original sources are linked where available.
“The V-LAP monitoring system proved to be generally safe and provided a good correlation with invasive PCWP. Initial evidence also suggests possible improvement in HF clinical symptoms that could be associated to a better outcome. Further studies are needed to test the efficacy of the device in heart failure patients.”
Implication
Supports feasibility of remote PCWP monitoring in HF; leaves open impact on outcomes pending randomized trials.
Key Points
- This study aims to assess the safety, usability, and performance of a novel left atrial pressure monitoring device in heart failure patients.
- First-in-human, prospective, multicenter, single-arm clinical trial enrolling 30 patients with heart failure.
- Device implanted to wirelessly transmit left atrial pressure data and correlate with pulmonary capillary wedge pressure.
- Patient management guided by remote left atrial pressure measurements over a 12-month follow-up.
- Device implantation achieved in all patients without acute major adverse cardiac events.
- At 3 months, freedom from short-term major adverse cardiac events was 97%.
- Improvement in NYHA functional class observed, with 32% of patients reaching NYHA II at 6 months (P<0.005) and 60% at 12 months (P<0.005).
Structured PICO
Is the V-LAP wireless left atrial pressure monitoring system safe and accurate in patients with heart failure?
P
Population
30 patients with heart failure enrolled in a first-in-human, prospective, multicenter, single-arm trial with follow-up up to 12 months.
I
Intervention
V-LAP monitoring system (interatrial positioned leadless sensor for wireless left atrial pressure transmission)
O
Outcome
Safety (freedom from short-term Major Adverse Cardiac and Neurological Events), usability, and performance (agreement between sensor-calculated LAP and PCWP at 3 months)safety
Main Result
Effect estimate: LCCC 0.776 (95% CI 0.582-0.886)
p-value: p=<0.0001
The V-LAP wireless left atrial pressure monitoring system is safe, accurately correlates with invasive PCWP, and its use to guide management is associated with improved clinical symptoms in heart failure patients.
Limitations
- Further studies are needed to test the efficacy of the device in heart failure patients.
Cite This Study
D’Amario et al. (2023) studied heart failure (n=30). V-LAP monitoring system was evaluated on Safety (freedom from short-term MACNE) and performance (agreement between sensor-calculated LAP and PCWP) at 3 months (LCCC 0.776, 95% CI 0.582-0.886, p=<0.0001). The V-LAP monitoring system was safe in heart failure patients, with 97% freedom from short-term MACNE at 3 months and good correlation with invasive PCWP (LCCC 0.776; 95% CI 0.582-0.886; P<0.0001).