The V-LAP System for Remote Left Atrial Pressure Monitoring of Patients With Heart Failure

• DOI: 10.1016/j.cardfail.2021.12.019
• Publication Date: 2022-01-15T16:22:10Z
• Authors: Leor Perl; David Meerkin; Domenico D'amario; Binyamin Ben Avraham; Tuvia Ben Gal; Tatyana Weitsman; Tal Hasin; Hüseyin Ince; Sebastian Feickert; Giuseppe D'ancona; Ulrich Schaefer; Horst Sievert; Francisco Leyva; Zachary I. Whinnett; Carlo Di Mario; Michael Jonas; Michael Glikson; Manhal Habib; Oren Caspi; Oran Koren; William T. Abraham; Ran Kornowski; Filippo Crea
• Keywords: Left atrial pressure; Interatrial septum

Patients with heart failure (HF) are at an increased risk of hospital admissions. The aim this report is to describe the feasibility, safety and accuracy a novel wireless left atrial pressure (LAP) monitoring system in patients HF.The V-LAP Left Atrium Monitoring systEm for With Chronic sysTOlic & Diastolic Congestive Failure (VECTOR-HF) study prospective, multicenter, single-arm, open-label, first-in human clinical trial assess safety, performance usability (Vectorious Medical Technologies) New York Heart Association class III HF. device was implanted interatrial septum via percutaneous, trans-septal approach guided by fluoroscopy echocardiography. Primary endpoints included successful deployment implant, ability perform initial measurements outcomes.To date, 24 have received implants LAP-monitoring device. No device-related complications occurred. LAP reported accurately, agreeing well wedge 3 months (Lin concordance correlation coefficient = 0.850). After 6 months, improved 40% (95% CI 16.4%-63.5%), while 6-minute walk test distance had not changed significantly (313.9 ± 144.9 vs 232.5 129.9 meters; P 0.076).The atrium appears be safe accurate.