A novel wireless functioning for IntraValvular Impedance sensing in Heart Valve Bioprosthesis

This study presents the development and evaluation of a novel sensorized biological heart valve (BHV) prosthesis, which features a wireless system for real-time monitoring of valve function. The valve incorporates IntraValvular Impedance (IVI) sensing technology, enabling continuous assessment of leaflet motion and facilitating the early detection of subclinical leaflet thrombosis. This condition, characterized by reduced leaflet motion and thickening, can lead to valve dysfunction and complications such as stroke or heart failure if not detected in its early stages. Current diagnostic methods for valve function monitoring are often limited by factors such as high radiation exposure, logistical challenges, and the need for frequent imaging. In contrast, the sensorized BHV uses miniaturized electrodes embedded within the valve structure to detect dynamic changes in leaflet motion throughout the valve’s opening and closing phases, offering a more efficient alternative for continuous monitoring. The presented novel IVI system is powered and communicates data wirelessly through Transcutaneous Energy Transmission (TET), eliminating the need for external connections. In vitro tests were performed using a Pulse Duplicator to simulate physiological conditions of valve functioning and evaluate the performance of the novel wireless IVI system. The results demonstrated that the wireless IVI system, provides accurate and reliable measurements of leaflet motion, comparable to a previously validated wired system. The mean maximum impedance variation for the wireless system was consistent with the wired system across different electrode pairs, with minimal interference and high signal fidelity. Although the wireless prototype showed promising results, challenges remain in miniaturizing the circuitry and optimizing coil integration. Further development of the system’s design and power efficiency is needed. Nevertheless, this research highlights the potential of the wireless IVI system to revolutionize valve monitoring, offering continuous, non-invasive, and early detection of functional impairments, which could ultimately improve patient outcomes and reduce reliance on periodic imaging.