The V-LAP System for Remote Left Atrial Pressure Monitoring of Patients With Heart Failure: Remote Left Atrial Pressure Monitoring.
J Card Fail
; 28(6): 963-972, 2022 06.
Article
in En
| MEDLINE
| ID: mdl-35041933
ABSTRACT
OBJECTIVE:
Patients with heart failure (HF) are at an increased risk of hospital admissions. The aim of this report is to describe the feasibility, safety and accuracy of a novel wireless left atrial pressure (LAP) monitoring system in patients with HF.METHODS:
The V-LAP Left Atrium Monitoring systEm for Patients With Chronic sysTOlic & Diastolic Congestive heart Failure (VECTOR-HF) study is a prospective, multicenter, single-arm, open-label, first-in human clinical trial to assess the safety, performance and usability of the V-LAP system (Vectorious Medical Technologies) in patients with New York Heart Association class III HF. The device was implanted in the interatrial septum via a percutaneous, trans-septal approach guided by fluoroscopy and echocardiography. Primary endpoints included the successful deployment of the implant, the ability to perform initial pressure measurements and safety outcomes.RESULTS:
To date, 24 patients have received implants of the LAP-monitoring device. No device-related complications have occurred. LAP was reported accurately, agreeing well with wedge pressure at 3 months (Lin concordance correlation coefficientâ¯=â¯0.850). After 6 months, New York Heart Association class improved in 40% of the patients (95% CIâ¯=â¯16.4%-63.5%), while the 6-minute walk test distance had not changed significantly (313.9 ± 144.9 vs 232.5 ± 129.9 meters; Pâ¯=â¯0.076).CONCLUSION:
The V-LAP left atrium monitoring system appears to be safe and accurate.Key words
Full text:
1
Collection:
01-internacional
Database:
MEDLINE
Main subject:
Atrial Pressure
/
Heart Failure
Type of study:
Clinical_trials
/
Observational_studies
/
Risk_factors_studies
Limits:
Humans
Language:
En
Journal:
J Card Fail
Journal subject:
CARDIOLOGIA
Year:
2022
Document type:
Article