A novel sensorized heart valve prosthesis: Preliminary in vitro evaluation

Background: Recent studies have shown that subclinical valve thrombosis in heart valve prosthesis (HVP) can be responsible for reduced leaflet motion detectable only by advanced imaging diagnostics. We conceived a novel sensorized HVP able to detect earlier any thrombus formation that may alter the leaflets motion using an electric impedance measurement, IntraValvular Impedance (IVI). Methods: For IVI measurement, dedicated electrodes are embedded in the structure of the HVP to generate a local electric field that is altered by the moving valve leaflets during their cyclic opening/closing. We present preliminary in vitro results using a first prototype of sensorized mechanical heart valve connected to an external impedance measurement system. The prototype was tested on a circulatory mock loop system and the IVI signals were recorded during both normal dynamics and experimentally induced altered working of the leaflets. Results: Recordings showed a very repetitive and stable IVI signal during the normal cyclic opening/closing of the HVP. The induced alterations in leaflet motion were reflected in the IVI signal. Conclusions: The novel sensorized HVP has great potential to give early warning of possible subclinical valve thrombosis altering the valve leaflet motion, and to help in tailoring the anticoagulation therapy.