In order to better explain the final setup of SensorART project, it seems important to underline that, in spite of its relatively short lifespan, the changing clinical scenario, characterized by marked improvement in early outcome and longer and longer duration of mechanical support therapy, moved the main clinical targets from prediction of early death/adverse events to long term issues: monitoring of cardiac function, device performance, and patient-device interaction; patient surveillance for early diagnosis of long term complications; facilitation of coping and acceptance of the device, for which the presence of the driveline for energy supply represents the major obstacle. The technological value of the SensorART project, highly focused on the development of new physical components some of them implantable, thus subject to severe regulatory and patient safety issues, required the definition of rigorous testing protocols in the experimental arena before any possible pilot study on humans. These remarks underline the relevance of the main scope of the SensorART project, especially in terms of "hardware" components (hemodynamic and implantable sensors; transcutaneous energy transmission), which, as stated before, should be rigorously tested in the experimental setting and strictly regulated and controlled before being approved for pilot application in humans. In the fourth and final year of the project, the background for the new generation of sensorized "intelligent" VADs has been established. In fact, in the experimental laboratories as well in clinical arena, the main features of SensorART platforms reached the demonstration steps, even if for some modules on bench and in vivo proof of concepts and not as complete validation on patients because of the different technology readiness level and validation procedures needed for such a complex and ambitious project. Within the multiple hurdles that the different tasks of the project had to face and overcome, causing long delays, we must underline the additional value represented by the junior team members which, as reported in outreach articles (*), by acting as a "trait d'union" among the different partners and laboratories, often helped the project coordinator to solve problems all along the project till the last period. Besides the scientific activity, a sound collaboration among the Principal Investigators of the prestigious organizations involved in this project supported by an efficient Junior Team carried out also an intensive dissemination activity through the participation to international conferences and publications of papers in international peer reviewed journals. The Junior Team publications evidence both the quality of the individual work carried out within each research centre and the fruitful cooperation among groups as reported in deliverable of dissemination. More publications are expected from now onwards from industrial partners and bioengineering specialists, until now blocked by confidentiality of the achievements . An excellence within the project is also represented by the UCBL group whose activity was focused on the development of biosensors for the study of biomarkers useful to monitor VAD patients and possibly to detect heart recovery. Their results and achievements gave to the project the perspective of the use of biosensors as a tool for patients monitoring at home, for the early detection of inflammation markers and other markers of VAD adverse events. The clinical monitoring of VAD implanted patients and study on biomarkers allow to obtain a cultural background and important data on the possibility of heart recovery, despite the severity and the advanced degree of the disease. The collaboration with the excellent team of UCBLgave to the project in perspective the exploitable plan on a point of care at home of the patients in the follow up for the early detection of inflammation markers and other important substances for heart failure relapses. Main achievements have been also obtained in implantable sensors developments, tested in acute and chronic experimental settings, capable to give data relative to device/recipient interactions and then suggest the possible modulation/regulation of required support. Huge work has been done by em-tec industrial partner for the transcutaneous energy transfer (TET) in order to abolish the VAD cables and to develop the implantable telemetry system: it has been shown that a stable (power-controlled), implantable TET and Telemetry can be realized. The designed system surely covers the needs of the SensorART project and it is flexible enough for integration and adaptation to the needs of current and future VAD systems. Besides these results, the implementation by SSSA with Autoregulation Unit (ARU), which could be considered the high-tech heart support modulator or the electronic "intelligence" of the heart, has been successfully demonstrated in the experimental scenario by activating also the wireless data sending to specialist environment throughout the Patient Monitor Application. In fact, the ARU developed by the SSSA group represents the central command of the new sensorized VAD, able to collect data coming from implantable and wearable sensors and elaborate them through a microcontroller. According to the data received, the ARU permits to individuate and regulate the best pump speed level for that specific hemodynamic condition. In a futuristic vision, the ARU will permit to monitor patients' condition by acquiring data from both implantable and wearable sensors and automatically control VAD speed accordingly. In this sense the ARU will provide a modulated support able to adapt the level of support on the basis of patient's needs. In this scenario the clinician will be only a supervisor of an automated system and will operate in the process only in emergency conditions or in case of autoregulation failure. Another important activity was carried out by the CNR (Roma and Pisa) and IBBE-PAS (Warsaw) groups. Their strict cooperation led to the development of a simulation tool for the study and analysis of VAD therapy. The simulator, developed within SensorART, allows to reproduce the cardiovascular system and its interaction with different types of VADs: apical, atrio-aortic, partial and full support. It was developed in two versions: a fully computational version and a hybrid(hydro-numerical) version. This latter permits the connection of a real VAD and to test it in different hemodynamic conditions. The simulator described so far is conceived as a powerful tool for multiple use: Clinical use: the simulator gives the possibility to simulate specific patients' hemodynamic conditions. In this scenario clinicians can insert patients' data and observe patients' status, they can simulate different possible therapeutic strategies (i.e. drug administration - VAD therapy) and observe patients' virtual outcome. The simulator was used in cooperation with the Leuven Katholieke Universiteit to simulate the short term effects of VAD implantation on chronic heart failed patients and grown up congenital heart diseases patients. Similarly the simulator was used in cooperation with the Ospedale Niguarda in Milan to reproduce the effects of VAD implantation on heart failed patients with mitral and aortic regurgitation. Training use: the simulator can reproduce a wide set of predefined diseases (i.e. ischemic cardiomyopathy, systemic and pulmonary hypertension, valvular diseases etc..). Each pathology can be activated with a specific level of severity, alone or in combination with other diseases. Testing platform: the hybrid simulator is a powerful tool that can be connected with different devices. In this sense it is a test bench that permits to test any new device in different predefined working conditions avoiding ethical problems and costs issued relative to experimental arena. As an example the simulator was connected with the VAD autoregulation unit developed by the SSSA group. The simulator permitted to test and verify the autoregulation algorithms in a wide range of hemodynamic conditions. All these activities have been dedicated to develop original tools to be used to perform simulation and modelling and, after understanding the clinicians' needs, to develop specific applications aimed at meeting clinical and patient needs: in fact, one of the most promising developments has been the use of cardiovascular models to analyse clinical data and support the clinical decision making process, useful also for training novices. Finally, the final release of the integrated SensorART platform fully realizes the vision of innovative telemedicine services supporting not only the remote monitoring and treatment of patients with chronic heart failure, but also the remote management and control of the implanted cardiovascular assist devices. This latter is achieved by the close cooperation and tight integration of Patients' and Specialists' Monitoring Applications, promising reduced hospitalisation time, remote psychological support and eventually enhanced patients' quality of life. The main components of the platform are: sensorized pump, TET, telemetry, PMA, remote specialist environment in the futuristic application of telemedicine to VAD implanted patients. The FP7 SensorART project on sensorizing a new generation of cardiac assist devices, without cables and together with the "dream" of heart recovery, is allowing to look beyond the therapeutical frontiers from tomorrow.
D1.8 Periodic Activity Report (PAR)
Maria Giovanna Trivella
2014
Abstract
In order to better explain the final setup of SensorART project, it seems important to underline that, in spite of its relatively short lifespan, the changing clinical scenario, characterized by marked improvement in early outcome and longer and longer duration of mechanical support therapy, moved the main clinical targets from prediction of early death/adverse events to long term issues: monitoring of cardiac function, device performance, and patient-device interaction; patient surveillance for early diagnosis of long term complications; facilitation of coping and acceptance of the device, for which the presence of the driveline for energy supply represents the major obstacle. The technological value of the SensorART project, highly focused on the development of new physical components some of them implantable, thus subject to severe regulatory and patient safety issues, required the definition of rigorous testing protocols in the experimental arena before any possible pilot study on humans. These remarks underline the relevance of the main scope of the SensorART project, especially in terms of "hardware" components (hemodynamic and implantable sensors; transcutaneous energy transmission), which, as stated before, should be rigorously tested in the experimental setting and strictly regulated and controlled before being approved for pilot application in humans. In the fourth and final year of the project, the background for the new generation of sensorized "intelligent" VADs has been established. In fact, in the experimental laboratories as well in clinical arena, the main features of SensorART platforms reached the demonstration steps, even if for some modules on bench and in vivo proof of concepts and not as complete validation on patients because of the different technology readiness level and validation procedures needed for such a complex and ambitious project. Within the multiple hurdles that the different tasks of the project had to face and overcome, causing long delays, we must underline the additional value represented by the junior team members which, as reported in outreach articles (*), by acting as a "trait d'union" among the different partners and laboratories, often helped the project coordinator to solve problems all along the project till the last period. Besides the scientific activity, a sound collaboration among the Principal Investigators of the prestigious organizations involved in this project supported by an efficient Junior Team carried out also an intensive dissemination activity through the participation to international conferences and publications of papers in international peer reviewed journals. The Junior Team publications evidence both the quality of the individual work carried out within each research centre and the fruitful cooperation among groups as reported in deliverable of dissemination. More publications are expected from now onwards from industrial partners and bioengineering specialists, until now blocked by confidentiality of the achievements . An excellence within the project is also represented by the UCBL group whose activity was focused on the development of biosensors for the study of biomarkers useful to monitor VAD patients and possibly to detect heart recovery. Their results and achievements gave to the project the perspective of the use of biosensors as a tool for patients monitoring at home, for the early detection of inflammation markers and other markers of VAD adverse events. The clinical monitoring of VAD implanted patients and study on biomarkers allow to obtain a cultural background and important data on the possibility of heart recovery, despite the severity and the advanced degree of the disease. The collaboration with the excellent team of UCBLgave to the project in perspective the exploitable plan on a point of care at home of the patients in the follow up for the early detection of inflammation markers and other important substances for heart failure relapses. Main achievements have been also obtained in implantable sensors developments, tested in acute and chronic experimental settings, capable to give data relative to device/recipient interactions and then suggest the possible modulation/regulation of required support. Huge work has been done by em-tec industrial partner for the transcutaneous energy transfer (TET) in order to abolish the VAD cables and to develop the implantable telemetry system: it has been shown that a stable (power-controlled), implantable TET and Telemetry can be realized. The designed system surely covers the needs of the SensorART project and it is flexible enough for integration and adaptation to the needs of current and future VAD systems. Besides these results, the implementation by SSSA with Autoregulation Unit (ARU), which could be considered the high-tech heart support modulator or the electronic "intelligence" of the heart, has been successfully demonstrated in the experimental scenario by activating also the wireless data sending to specialist environment throughout the Patient Monitor Application. In fact, the ARU developed by the SSSA group represents the central command of the new sensorized VAD, able to collect data coming from implantable and wearable sensors and elaborate them through a microcontroller. According to the data received, the ARU permits to individuate and regulate the best pump speed level for that specific hemodynamic condition. In a futuristic vision, the ARU will permit to monitor patients' condition by acquiring data from both implantable and wearable sensors and automatically control VAD speed accordingly. In this sense the ARU will provide a modulated support able to adapt the level of support on the basis of patient's needs. In this scenario the clinician will be only a supervisor of an automated system and will operate in the process only in emergency conditions or in case of autoregulation failure. Another important activity was carried out by the CNR (Roma and Pisa) and IBBE-PAS (Warsaw) groups. Their strict cooperation led to the development of a simulation tool for the study and analysis of VAD therapy. The simulator, developed within SensorART, allows to reproduce the cardiovascular system and its interaction with different types of VADs: apical, atrio-aortic, partial and full support. It was developed in two versions: a fully computational version and a hybrid(hydro-numerical) version. This latter permits the connection of a real VAD and to test it in different hemodynamic conditions. The simulator described so far is conceived as a powerful tool for multiple use: Clinical use: the simulator gives the possibility to simulate specific patients' hemodynamic conditions. In this scenario clinicians can insert patients' data and observe patients' status, they can simulate different possible therapeutic strategies (i.e. drug administration - VAD therapy) and observe patients' virtual outcome. The simulator was used in cooperation with the Leuven Katholieke Universiteit to simulate the short term effects of VAD implantation on chronic heart failed patients and grown up congenital heart diseases patients. Similarly the simulator was used in cooperation with the Ospedale Niguarda in Milan to reproduce the effects of VAD implantation on heart failed patients with mitral and aortic regurgitation. Training use: the simulator can reproduce a wide set of predefined diseases (i.e. ischemic cardiomyopathy, systemic and pulmonary hypertension, valvular diseases etc..). Each pathology can be activated with a specific level of severity, alone or in combination with other diseases. Testing platform: the hybrid simulator is a powerful tool that can be connected with different devices. In this sense it is a test bench that permits to test any new device in different predefined working conditions avoiding ethical problems and costs issued relative to experimental arena. As an example the simulator was connected with the VAD autoregulation unit developed by the SSSA group. The simulator permitted to test and verify the autoregulation algorithms in a wide range of hemodynamic conditions. All these activities have been dedicated to develop original tools to be used to perform simulation and modelling and, after understanding the clinicians' needs, to develop specific applications aimed at meeting clinical and patient needs: in fact, one of the most promising developments has been the use of cardiovascular models to analyse clinical data and support the clinical decision making process, useful also for training novices. Finally, the final release of the integrated SensorART platform fully realizes the vision of innovative telemedicine services supporting not only the remote monitoring and treatment of patients with chronic heart failure, but also the remote management and control of the implanted cardiovascular assist devices. This latter is achieved by the close cooperation and tight integration of Patients' and Specialists' Monitoring Applications, promising reduced hospitalisation time, remote psychological support and eventually enhanced patients' quality of life. The main components of the platform are: sensorized pump, TET, telemetry, PMA, remote specialist environment in the futuristic application of telemedicine to VAD implanted patients. The FP7 SensorART project on sensorizing a new generation of cardiac assist devices, without cables and together with the "dream" of heart recovery, is allowing to look beyond the therapeutical frontiers from tomorrow.I documenti in IRIS sono protetti da copyright e tutti i diritti sono riservati, salvo diversa indicazione.
