A Novel Wireless Left Atrial Pressure Monitoring System for Patients with Heart Failure, First Ex-Vivo and Animal Experience
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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.
KeywordsHeart failure exacerbation Hemodynamics Left atrial pressure Telemonitoring
Left atrial pressure
Pulmonary capillary wedge pressure
This study was funded by Vectorious Medical Technologies.
Compliance with Ethical Standards
All animal procedures were performed in strict compliance with the Israeli National Council for Animal Experimentation and were approved by the national ethical committee (permit number IL-17-8-298).
Conflict of Interest
Author Perl owns stock options in Vectorious Medical Technologies. Author Soifer is an employee of Vectorious Medical Technologies. Author Batrunek has nothing to disclose. Author Erdheim is an employee of Vectorious Medical Technologies and owns stock options in the company. Author Köhler has received a speaker honorarium from Medtronic International and payment for lectures from Novartis. Author Abraham has received consulting fees from Vectorious Medical Technologies and consulting fees from Abbot. Author Meerkin has received consulting fee from Vectorious Medical Technologies and owns stock options in the company.
Statement on the Welfare of Animals
All applicable international, national, and/or institutional guidelines for the care and use of animals were followed. All procedures performed in studies involving animals were in accordance with the ethical standards of the institution or practice at which the studies were conducted. This article does not contain any studies with human participants performed by any of the authors.
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