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 coefficient = 0.850). After 6 months, New York Heart Association class improved in 40% of the patients (95% CI = 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; P = 0.076).Conclusion: The V-LAP left atrium monitoring system appears to be safe and accurate.
The V-LAP System for Remote Left Atrial Pressure Monitoring of Patients With Heart Failure: Remote Left Atrial Pressure Monitoring / Perl, L., Meerkin, D., D'amario, D., Avraham, B.B., Gal, T.B., Weitsman, T., Hasin, T., Ince, H., Feickert, S., D'ancona, G., Schaefer, U., Sievert, H., Leyva, F., Whinnett, Z.I., Di Mario, C., Jonas, M., Glikson, M., Habib, M., Caspi, O., Koren, O., et al.. - In: JOURNAL OF CARDIAC FAILURE. - ISSN 1071-9164. - STAMPA. - 28:(2022), pp. 963-972. [10.1016/j.cardfail.2021.12.019]
The V-LAP System for Remote Left Atrial Pressure Monitoring of Patients With Heart Failure: Remote Left Atrial Pressure Monitoring
D'ancona, Giuseppe;Di Mario, Carlo;
2022
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 coefficient = 0.850). After 6 months, New York Heart Association class improved in 40% of the patients (95% CI = 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; P = 0.076).Conclusion: The V-LAP left atrium monitoring system appears to be safe and accurate.
| File | Dimensione | Formato | |
|---|---|---|---|
|
PIIS1071916422000045.pdf
accesso aperto
Tipologia:
Pdf editoriale (Version of record)
Licenza:
Creative commons
Dimensione
890.07 kB
Formato
Adobe PDF
|
890.07 kB | Adobe PDF |
I documenti in FLORE sono protetti da copyright e tutti i diritti sono riservati, salvo diversa indicazione.
