Home Monitoring of Patients after Prosthetic Valve Surgery - Experimental Background and First Clinical Attempts

Abstract
Purpose: The purpose of this study was to investigate whether: 1. sound phenomena may be used to detect prosthetic valve dysfunction; 2. clinical and experimental data permit conclusions about alterations in the functional state of mechanical valves; 3. patients can record and pass on signals via Internet. Methods: 1. We implanted bi-leaflet valves in pigs. By gradually influencing the motion of the tilting discs prosthetic dysfunction could be generated. 2. Thrombosis and lysis of bi-leaflet valves was studied in sheep. This process was documented using echocardiography and acoustically by the Fast Fourier Transformation. 3. Thirty devices were set up and handed out to patients following mechanical valve replacement. All patients regularly sent data to the hospital via Internet, regardless of their location at the time. The data were evaluated by comparing them with the reference file. Results: Animal experiments proved that changes in prosthetic function led to a significant change in sound phenomena. In contrast to echocardiography alterations at an early stage (onset of thrombosis) could be reliably verified. The sensitivity was greater than in echo-control analysis. All patients regularly recorded and passed on their signals. Surveys revealed high acceptance and easy handling of the devices. Conclusions: Online registration of sound phenomena seems to be suitable for the detection of changes in prosthetic function. This led to the development of the first hand-held device for home monitoring of valve function. Registration of flow, frequency spectrum, and ECG envisaged at the next level opens up potential applications for Internet-based, remote monitoring of cardiac patients.