TY - JOUR
T1 - The V-LAP System for Remote Left Atrial Pressure Monitoring of Patients With Heart Failure
T2 - Remote Left Atrial Pressure Monitoring
AU - the VECTOR-HF Trial Investigators
AU - Perl, Leor
AU - Meerkin, David
AU - D'amario, Domenico
AU - Avraham, Binyamin Ben
AU - Gal, Tuvia Ben
AU - Weitsman, Tatyana
AU - Hasin, Tal
AU - Ince, Hüseyin
AU - Feickert, Sebastian
AU - D'ancona, Giuseppe
AU - Schaefer, Ulrich
AU - Sievert, Horst
AU - Leyva, Francisco
AU - Whinnett, Zachary I.
AU - Di Mario, Carlo
AU - Jonas, Michael
AU - Glikson, Michael
AU - Habib, Manhal
AU - Caspi, Oren
AU - Koren, Oran
AU - Abraham, William T.
AU - Kornowski, Ran
AU - Crea, Filippo
N1 - Publisher Copyright:
© 2022 The Author(s)
PY - 2022/6
Y1 - 2022/6
N2 - 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.
AB - 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.
KW - Invasive pressure monitoring
KW - heart failure
UR - https://www.scopus.com/pages/publications/85125373503
U2 - 10.1016/j.cardfail.2021.12.019
DO - 10.1016/j.cardfail.2021.12.019
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C2 - 35041933
AN - SCOPUS:85125373503
SN - 1071-9164
VL - 28
SP - 963
EP - 972
JO - Journal of Cardiac Failure
JF - Journal of Cardiac Failure
IS - 6
ER -