SensorART aims at sensorizing Ventricular Assist Devices (VADs), in order to turn VADs from mechanical devices into intelligent systems allowing patients suffering from heart failure to conduct normal lives and help healthcare professionals to monitor patient status remotely and in real-time. In this way, VADs could adjust autonomously to the patients’ physical needs and monitor his/her status. Most importantly, intelligent VAD systems could be used not only as a bridge to transplant, but also as destination therapy, and in a futurist vision as transient therapeutic tools for heart recovery.

Current treatment of heart failure consists of ventricular assist devices (VADs), mechanical pumps implanted in the patient’s body used to restore blood circulation. At present, however, VADs are used mainly to bridge heart transplantation.

In practice this means that in patients with implanted sensorised artificial heart, the device is linked wirelessly to an external control unit, which is applied to the waist by means of a belt. The artificial heart is powered wirelessly by an innovative system for energy transfer via the skin.

Thanks to different assembled sensors, as well as to special algorithms, the control unit can monitor the patient’s physiological conditions and optimise support from the pump. In this way, the empowered patient can lead a normal life. Moreover, via wireless Internet communication, the control unit allows doctors to monitor the patient’s status in real-time and remotely, and to take immediate action when required.

Policy Context

Heart failure (HF) is the most increasing cause of death in Western Countries. For that reason, together with the difficulty of having a sufficient number of donor organs, it is recognised that the device-based therapeutic approaches will assume an increasingly important role in treating the growing number of patients with advanced heart failure, not only as bridge to transplant, but also as destination therapy, by considering also the ageing population.

Mechanical artificial hearts are currently used as a bridge to heart transplantation and more recently, as “destination therapy” due to the shortage of heart donors as well as increasing pathology in the aging society. There is experimental evidence that chronic unloading of the heart leads to improved heart function. Clinical experiences report the possibility of improving cardiac function to the extent that the patient could be weaned from the device and transplantation avoided. Heart recovery mechanisms and related time are still unknown since today assist devices are mainly implanted in patients with end-stage heart failure.

The clinical significance of such bridge-to-recovery strategy is emerging. It allows the implant of the devices: 1) as an alternative to heart transplantation, 2) in case of life-threatening device-related complications (e.g. recurrent thromboembolism or device infection), 3) when urgent transplantation is unfeasible.

In future, a changing approach by a possible use of devices in earlier phases of disease, less critical, together with increasingly powerful, miniaturized pumps, could be considered in perspectives important elements to transiently unload the natural heart and lead to its recovery.

The project is funded under the 7th FWP (Seventh Framework Programme), GA 248763.

Description of target users and groups

Project stakeholders include patients (candidates and recipients of VAD therapy, plus their caregivers), medical professionals (clinicians, cardio surgeons, nurses, VAD producers, health care trainers, novices) and possibly the organisations (ICT and bioengineering companies) that could utilize the results of the project for the development of their products. The health authorities can derive from the clinical scenarios and the cost comparisons some indications for strategic decisions within future budgets and health programmes for citizens.

The current era is characterised by an intense research activity in patient remote monitoring, with the scope to 1) improve patient knowledge and self-confidence regarding his/her disease and of how to live with it, 2) make the patient feel safer due to persistent medical control even at a distance, 3) spare time and costs for traveling to and from the medical center for the patients and their families, 4) reduce the need for hospital/ ambulatory facilities by moving patient surveillance from the hospital to home. In cardiac conditions such as heart failure and electric device implantation (ICDs), some studies have suggested that telecardiology may improve patient outcome and safety.

Telecardiology for monitoring of chronic heart failure therapy has been based mostly on the patient/medical and nurse staff relationship. Patient education and self-monitoring are important components, and will probably remain so even in the era of evolving technology.

VAD therapy is applied in an increasing number of patients, and although initially intended as a bridge to transplantation it is becoming a long-term therapy in many subjects due to donor shortage. Adding monitoring facilities to VAD and VAD recipients could help in understanding patient-device adaptation, suggesting changes in therapy, and recognising early signs of complications.

Description of the way to implement the initiative

SensorART aims to provide a set of technologies for heart assistance, supporting patients with chronic heart failure, treated at home without renouncing to access high medical expertise, and healthcare professionals, keeping under control the performance of cardiovascular implanted Ventricular Assist Devices (VAD) by tele-control services.

With these objectives, three different platforms will be developed: Implantable, Wearable and Point of care.

The implantable platform is VAD-dependent and is strictly related to an Auto Regulation Unit, which will be responsible for the data acquisition and management, the VAD setting and monitoring and the data transmission to patient and specialist interfaces.

The wearable platform will be VAD-independent, with the purpose to acquire as many physiological parameters as possible to collect information about patient status and to support the specialist. Additional data will be acquired by the Point of Care platform, which has the potential to be a valuable tool for collecting data about inflammatory biomarkers.

Technology solution

Technical objectives of the project are the following:

• Design, develop and test an open and interoperable device-independent platform supporting personalised care, telemonitoring and telecontrol, able to interact with the cardiac support systems already on the market.
• Integrate two main systems VAD–Heart Simulation Platform (VHSP) and the Specialist’s Decision Support System (SDSS). The VAD–Heart Simulation Platform is a hybrid circulatory modelling platform permitting the observation of the “virtual” interaction between a ventricular assist device model and a heart model. The Specialist’s Decision Support System is a Web-based application that assists specialists on designing the best treatment plan for their patients before and after Ventricular Assist Device (VAD) implantation, analysing patients’ data, extracting new knowledge, and making informative decisions. It creates a hallmark in the field, supporting medical and VAD experts through the different phases of VAD therapy. Rather than addressing a single issue, the SensorART SDSS enables specialists with advanced data-driven techniques and expert-knowledge techniques, in order to effectively assess and exploit real patient data, as well as simulated patient data.
• Implement a set of wireless and transcutaneous energy transfer microsensors able to collect in real time and on daily basis the patient-specific signals, according to specific reactions and/or reflexes, as well as the parameters to check "pumping" action of the VADS.
• Evaluate biomarkers of clinical relevance (chemical, biological or neurohumoral) in order to early detect inflammation / infections / heart failure relapses / pump malfunction.

Main results, benefits and impacts

Among the expected results of the SensorART project are:

• Monitor and control patient – device interactions
• Therapeutic intervention optimisation
• Modelling and simulation of cardiac and circulatory dynamics of individual patient’s status across different conditions
• Increase device acceptability mainly due to abolishing cables
• Patient training and empowerment for patient’s independence and quality of life
• Futuristic Medical Device interacting with patients and care providers by intensive use of Mobile technology to set and control clinical and technical parameters
• Reduce hospitalisation time and cost of home support
• Increase applicability of VADs as bridge to transplant and as destination therapy
• Specific training of health care providers
• Impact on healthcare delivery

Return on Investment
It is difficult to provide the amount for investment return. During and by the dissemination activities up to now, the feelings are that possible future lines of research can derive from SensoraRT platform. This means future opportunities of other derived projects, together with a concrete educational program on versatile young european researchers in the field of interdisciplinarity. Within the ESAO (European Society for Artificial Organs), thanks to the project visibility and general appreciation, the coordinator (MD, cardiologist) has been elected among the board of society governors and the young bioengineering coworker has been elected as coordinator of the Young ESAO Group (www.esao.org). We are in the way of future applications and we found a general enthusiastic willingness for cooperation in bioengineering field as well as in clinical arena.

Track record of sharing

Within the limits of IPR that are present during an ongoing project, up to now the only possibility has been the transmission of the experience for coordinating a complex integrated project in the ICT area together with the presentations/publications of the obtained research data.

The dissemination of the whole project has been performed in Europe and in Japan. For some specific fields (Computer Science, Biosensors...) the international dissemination has reached USA, China, Mexico, Morocco etc (see figure below).

The dissemination of the project reached also Pan European Networks Science and Tecnology (http://www.paneuropeannetworks.com/science-and-technology.html) and it will be present within the publication number 8-2013 with a distribution to all government agencies and departments across Europe.

Lessons learnt

The interdisciplinarity of the Consortium obliged to a constructive translation and cultural exchange of different languages. For this reason the main lessons that the coordinator learned are:

1. The activities of the project, due to the required multiple competences, must be organised in modules, representing the different areas of disciplines. The multiple, parallel modules in SensorART are: bioengineering laboratories working on different components, experimental laboratories for testing, clinical arena with cardiologists, intensivists and cardiosurgeons acting on different actions relative to clinical requirements definition, data collection from patients, psychological support and personalised empowerment plans; modeling and simulation centers, where data from VAD implanted patient as well as from experimental laboratories are analysed for interactions and utilized for simulation platform, in order to define ICT modules (telemonitoring, telecontrol, training) and to feed  a dedicated Specialist’s Decision Support System.
2. The need of organising a SensorART junior team, working on weekly basis, able to induce and actively maintain collaboration among the different activities. In fact, the junior team represents the “trait d’union” among the different partners and disciplines of the project and a concrete, real working arm, helping the project coordinator to understand and to overcome ongoing problems.  
3. Despite of difficulties, it is important to keep in mind the futuristic vision and the innovative fields of the project even if it is necessary to follow always a right methodology, maintain the awareness on risk assessment, as well as on clinical team requirements, technical partners needs, and finally industrial partners concrete and realistic plans.