First Ex Vivo Animal Study of a Biological Heart Valve Prosthesis Sensorized with Intravalvular Impedance.

IntraValvular Impedance (IVI) sensing is an innovative concept for monitoring heart valve prostheses after implant. We recently demonstrated IVI sensing feasible in vitro for biological heart valves (BHVs). In this study, for the first time, we investigate ex vivo the IVI sensing applied to a BHV when it is surrounded by biological tissue, similar to a real implant condition. A commercial model of BHV was sensorized with three miniaturized electrodes embedded in the commissures of the valve leaflets and connected to an external impedance measurement unit. To perform ex vivo animal tests, the sensorized BHV was implanted in the aortic position of an explanted porcine heart, which was connected to a cardiac BioSimulator platform. The IVI signal was recorded in different dynamic cardiac conditions reproduced with the BioSimulator, varying the cardiac cycle rate and the stroke volume. For each condition, the maximum percent variation in the IVI signal was evaluated and compared. The IVI signal was also processed to calculate its first derivative (dIVI/dt), which should reflect the rate of the valve leaflets opening/closing. The results demonstrated that the IVI signal is well detectable when the sensorized BHV is surrounded by biological tissue, maintaining the similar increasing/decreasing trend that was found during in vitro experiments. The signal can also be informative on the rate of valve opening/closing, as indicated by the changes in dIVI/dt in different dynamic cardiac conditions.

Innovative IntraValvular Impedance Sensing Applied to Biological Heart Valve Prostheses: Design and In Vitro Evaluation.

Subclinical valve thrombosis in heart valve prostheses is characterized by the progressive reduction in leaflet motion detectable with advanced imaging diagnostics. However, without routine imaging surveillance, this subclinical thrombosis may be underdiagnosed. We recently proposed the novel concept of a sensorized heart valve prosthesis based on electrical impedance measurement (IntraValvular Impedance, IVI) using miniaturized electrodes embedded in the valve structure to generate a local electric field that is altered by the cyclic movement of the leaflets. In this study, we investigated the feasibility of the novel IVI-sensing concept applied to biological heart valves (BHVs). Three proof-of-concept prototypes of sensorized BHVs were assembled with different size, geometry and positioning of the electrodes to identify the optimal IVI-measurement configuration. Each prototype was tested in vitro on a hydrodynamic heart valve assessment platform. IVI signal was closely related to the electrodes' positioning in the valve structure and showed greater sensitivity in the prototype with small electrodes embedded in the valve commissures. The novel concept of IVI sensing is feasible on BHVs and has great potential for monitoring the valve condition after implant, allowing for early detection of subclinical valve thrombosis and timely selection of an appropriate anticoagulation therapy.

Assessment of a novel patient-specific 3D printed multi-material simulator for endoscopic sinus surgery.

Background: Three-dimensional (3D) printing is an emerging tool in the creation of anatomical models for surgical training. Its use in endoscopic sinus surgery (ESS) has been limited because of the difficulty in replicating the anatomical details. Aim: To describe the development of a patient-specific 3D printed multi-material simulator for use in ESS, and to validate it as a training tool among a group of residents and experts in ear-nose-throat (ENT) surgery. Methods: Advanced material jetting 3D printing technology was used to produce both soft tissues and bony structures of the simulator to increase anatomical realism and tactile feedback of the model. A total of 3 ENT residents and 9 ENT specialists were recruited to perform both non-destructive tasks and ESS steps on the model. The anatomical fidelity and the usefulness of the simulator in ESS training were evaluated through specific questionnaires. Results: The tasks were accomplished by 100% of participants and the survey showed overall high scores both for anatomy fidelity and usefulness in training. Dacryocystorhinostomy, medial antrostomy, and turbinectomy were rated as accurately replicable on the simulator by 75% of participants. Positive scores were obtained also for ethmoidectomy and DRAF procedures, while the replication of sphenoidotomy received neutral ratings by half of the participants. Conclusion: This study demonstrates that a 3D printed multi-material model of the sino-nasal anatomy can be generated with a high level of anatomical accuracy and haptic response. This technology has the potential to be useful in surgical training as an alternative or complementary tool to cadaveric dissection.