Why the study?
Direct left-sided haemodynamic sensors offer theoretical benefits beyond pulmonary artery pressure monitoring systems, but the safety, usability, and performance of a novel left atrial pressure monitoring system 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
Novel wireless left atrial pressure monitoring system
Design
First-in-human prospective multicentre single-arm clinical trial
Follow-up
12 months
Key result
The V-LAP wireless left atrial pressure monitoring system was safely implanted in 30 heart failure patients (97% freedom from MACNE at 3 months) and correlated well with PCWP (concordance 0.776).
Authors
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LAP monitoring appears feasible in HF; hypothesis-generating for clinical benefit, randomized trials needed before practice change.
Is the V-LAP wireless left atrial pressure monitoring system safe and accurate in patients with heart failure?
Effect estimate: Lin's concordance correlation coefficient 0.776 (95% CI 0.582-0.886)
p-value: p=<0.0001
The V-LAP wireless left atrial pressure monitoring system is safe to implant and provides accurate pressure measurements compared to invasive PCWP, with preliminary evidence of clinical symptom improvement in heart failure patients.
D’Amario et al. (2023) studied Heart failure (n=30). V-LAP monitoring system was evaluated on Agreement between sensor-calculated LAP and PCWP at 3 months (Lin's concordance correlation coefficient 0.776, 95% CI 0.582-0.886, p=<0.0001). The V-LAP wireless left atrial pressure monitoring system was safely implanted in 30 heart failure patients (97% freedom from MACNE at 3 months) and correlated well with PCWP (concordance 0.776).
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