Heart failure & cardiomyopathies

Physician-Directed Patient Self-Management in Heart Failure Using Left Atrial Pressure: Interim Insights from the VECTOR-HF I and IIa Studies

Eur J Heart FailPublished Interim analysis of prospective single-arm clinical trials

Authors' conclusion

Interim findings suggest that PSM using a LAP monitoring system is feasible and safe.

Study context

Population
NYHA class II and III heart failure (HF) patients with an implanted left atrial pressure (LAP) sensorinterim analysis
Participants
13 participants
Exposure
LAP-guided patient self-management vs period prior to patient self-management (PSM)
  • PSMn = 13
Outcome
Ability to perform LAP measurements and transmit data to the HCP interface and patient guidance application; safety outcomes
Follow-up
12 months
Methodological detailsVECTOR-HF I and IIa, open-label
  • VECTOR-HF I and IIa
  • Open-label

Main finding

As reported in the abstract

Failures to obtain sensor measurements and transmit data to healthcare provider (HCP) interface and patient guidance application
0

Observational data: associations, not effects.

Further findings

OutcomeP value
Annualized HF hospitalization rate, PSM vs similar period before PSM · 11.84 months0 admissions vs. 0.69 admissions over 11.84 months · interim analysisP = 0.004

Patient adherence

Patient adherence
91.4%
  • Interim analysis

6-min walk test distance and KCCQ overall summary score · 6 months

Significant improvement in 6-min walk test distance and KCCQ overall summary score

Safety

OutcomeValues
Procedure- or device-related major adverse CV or neurological events · 12 monthsInterim analysisPSM 0 events

Original publication

Physician-Directed Patient Self-Management in Heart Failure Using Left Atrial Pressure: Interim Insights from the VECTOR-HF I and IIa Studies. Eur J Heart Fail. Published 20 June 2024. doi:10.1002/ejhf.3338

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