Heart failure & cardiomyopathies
Safety, Usability, and Performance of a Wireless Left Atrial Pressure Monitoring System in Patients with Heart Failure: The VECTOR-HF Trial
Authors' conclusion
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.
Study context
- Population
- Patients with heart failure (HF)
- Participants
- 30 patients
- Outcome
- Safety (freedom from MACNE), usability and performance (agreement of sensor LAP with PCWP)
- Follow-up
- 3 months
Methodological detailsfirst-in-human, prospective, multicentre
- First-in-human
- Prospective
- Multicentre
Main finding
As reported in the abstract
Mean difference
−0.22 mmHg
± 4.92
Correlation coefficient
0.79
P < 0.0001
Agreement between sensor left atrial pressure (LAP) and pulmonary capillary wedge pressure (PCWP)
Lin's concordance correlation coefficient
0.776
95% CI 0.582–0.886
Agreement between sensor LAP and PCWP
Observational data: associations, not effects.
Further findings
| Outcome | Values |
|---|---|
| NYHA class II reached · 6 and 12 months | V-LAP 6 months 32% (p < 0.005) · 12 months 60% (p < 0.005) |
| 6-min walk distance · baseline, 6 and 12 months | V-LAP Baseline 244.59 ± 119.59 m · 6 months 311.78 ± 129.88 m (p < 0.05) · 12 months 343.95 ± 146.15 m (p < 0.05) |
Safety
Freedom from short-term major adverse cardiac and neurological events (MACNE) · 3 months
- Successfully implanted in all 30 patients, without acute MACNE
Parts of this Brief are withheld: the automatic checks could not confirm them against the abstract.
Original publication
Composed by AI from the published abstract and checked against it. How Briefs are made →