A Novel Wireless Left Atrial Pressure Monitoring System for Patients with Heart Failure, First Ex-Vivo and Animal Experience

Abstract

The V-LAP™ measures left atrial pressure (LAP) and enables bi-directional communications with an external unit, designed to monitor heart failure patients. We hereby describe the pre-clinical experience. Following an ex vivo phase, the system was implanted at the interatrial septum of 10 ovine subjects. LAP readouts were compared with pulmonary capillary wedge pressure (PCWP) at index procedure and 1, 2 and 3-6 months after the implantation, at rest and after volume loading. Histopathology assessment (n = 8) was performed up to 50 weeks post procedure. Procedural success was 100%. Measurements showed a mean difference of 0.19 ± 2.51 mmHg. During this period, correlation of V-LAP™ with PCWP was excellent (R² = 0.95, for 119 total measurements). There were no major adverse events related to the V-LAP™ system. In an animal model, the implantation of the novel wireless left atrial pressure sensor V-LAP™ was feasible, safe, and showed good accuracy and precision.

Keywords: Heart failure exacerbation; Hemodynamics; Left atrial pressure; Telemonitoring.