The project involves the development of a prototype home-care surveillance system that will enable frequent, long-term, remote
monitoring of arteriovenous fistulas in dialysis patients. The system will rely on ad-hoc designed sensors with the unique capability
of simultaneously recording the pulse, thrill, and bruit sounds of the AVF, unobtrusively from a patient’s forearm. The acquired data
would then be transmitted via the patient’s smartphone to a server or cloud service, where they would be processed, analyzed and
made available to the medical unit in charge of patient’s care, along with additional quantitative indices of AVF function and early
warnings about possible dysfunctions (e.g., stenoses).
The surveillance system would bring significant improvements in dialysis patients management. Indeed, it could be used both to
significantly increase the frequency of AVF monitoring, which would allow the medical staff to detect possible threatening conditions
at early stages and provide timely intervention to prevent unnecessary hospitalizations, and, at the same time, to reduce the
number of routine physical examinations, thus saving time and costs for the healthcare services. Increasing the frequency of
monitoring, while reducing the number of routine physical examinations, would have an enormous impact on the quality, efficacy
and efficiency of healthcare services, as it would significantly improve patients’ quality of life and also provide substantial costs
savings for the national healthcare system. Medical centers providing service in vascular surgery and dialysis units can be
considered the main target for using the proposed monitoring system.
Impacts
The project will provide a significant contribution in the advancement of scientific knowledge on the physiological and pathological
behavior of arteriovenous fistulas and their optimal management, based on early detection of dysfunctions development and timely
interventions to prevent unnecessary hospitalizations. The main contributions can be summarized as follows:
- Development of a methodology for unobtrusive, non-invasive, simultaneous recording of pulse, thrills, and bruit sounds of an
arteriovenous fistula from a patient’s forearm, which is currently not feasible with the methods and technologies presented in
literature; - Investigation on quantitative analysis of pulse and thrill of AVFs, which has never been reported in literature and could provide
additional insights into the physiological and pathological behavior of AVFs, as testified by the importance of physical assessment of
such clinical manifestations via palpation in routine patient visits; - Public availability of a large database of unprecedented patient data with recordings of pulse, thrill, and bruit sounds, along with
medical annotations and clinical parameters obtained via standard medical instrumentation, which will be unique to this project and
could foster future research on assessment and early diagnosis of AVF dysfunctions from data that could be acquired remotely and
frequently acquired from patients at home. - Definition and extraction of possible novel quantitative indices of AVF function, which could help to improve the capability of
recognizing the development of AVF dysfunctions at early stages.
Development of artificial intelligence approaches for medical decision support aimed at recognition, staging, and risk stratification
of patients with AVF dysfunctions, with the aim of sending early warnings and empowering the medical staff to perform timely
diagnosis of potential threatening conditions and to provide prompt intervention to prevent unnecessary hospitalizations.
The project will therefore contribute to advance the knowledge on the non-imaging diagnostics on arteriovenous fistulas. The
research activities that will be carried out within the project will inherently lead to a deeper comprehension of the pathological
origins of modifications observed in pulse, thrill and bruit sounds at the AVF site or along the vein. The project will also advance
knowledge on the design and implementation of novel signal processing and artificial intelligence approaches for the quantitative
assessment of an AVF function and the development of dysfunctions, thus promoting further research.
In addition, the use of the home-care surveillance system will generate large amounts of data from various patients. The public
availability of these large databases will provide new insights for research in the field of pathophysiology. Moreover, new information
and novel paradigms for medical data processing will likely emerge, which would feed the research in the fields of medicine and
biomedical engineering. As an example, by taking advantage of machine learning and deep learning strategies to analyze this large
amount of data, it would be possible to extract additional diagnostic information and long-term physiological trends.
The results obtained will support new approaches to patient care and management through the paradigm of personalized medicine.
The smart personal monitoring will provide an objective basis for differentiation between individuals or groups of individuals to adopt
different healthcare strategies and approaches, by tailoring prevention and therapy to the individual patient based on his predicted
response or risk of disease.
The results of this research project will also stimulate and provide the means for further investigation on various aspects of AVF
function and dysfunctions, e.g. by extracting quantitative indices also from measurements of pulse and thrill on AVF, which have not
been addressed yet in research.
The sensors for the simultaneous recording of pulse, thrill, and bruit sounds, that will be developed within the project represent a
new technology that could empower other medical research units to acquire their own data in clinical environments. The home-care
surveillance system that will be implemented during the project represents a further technology that will enable more frequent,
remote monitoring and on a much larger cohort of patients, also in non-clinical settings, thus allowing a medical research unit to
significantly increase the amount of patient data that could be collected.
The results of the project will be also exploited to propose a SpinOff offering to industries at national and international level: (i)
services of telemedicine and remote control to enabling connected care; (ii) design and development of specific medical devices and
instruments with the aim of improving care management and increasing patients quality of life.
The industrial impact of the project is confirmed by endorsement letters from NephroCare top player provides services in dialysis
units and management and care of vascular access in more than 40 countries across Europe, Middle East, Africa and Latin America.
The long-term economic impact of the proposed research is potentially relevant. In fact, the use of the methodologies and
technologies that will be demonstrated for the first time in this project will improve the management of dialysis patients. The ability
to recognize potential AVF dysfunctions at early stages would help to prevent unnecessary hospitalizations, thus yielding
considerable savings on the enormous healthcare expenditures, due to the ever-increasing number of dialysis patients.
Undoubtedly, the development of telemedicine systems integrated with the proposed system will allow a complete and safe dialysis
patient management at negligible costs, as compared to the economic benefits that could be earned via the use of this new
home-care surveillance system.
Saving costs for the National Health System is intimately linked to increasing the health of patients. The well-being of a patient can
be equated to an increase in the productivity of a country and thus can be valued in terms of monetary units. Therefore, the
proposed research theme tends to obtain a benefit for the patient and the community and a simultaneous considerable saving for
the National Health System. The socio-economic benefits of increasing the quality of life of patients and involving family members in
patient care are intuitive.
Telemedicine positively impacts the travel costs of 85% of patients. The adoption of telemedicine-based models of care and
treatment has benefits from a social and sustainability perspective, especially when considering travel time and costs. Even without
going into more complex analyses, it is immediate to assess the impact that a remote visit can have, particularly for patients with
chronic diseases who often reside in out-of-town areas and are treated by specialized centers, often even outside the region. It
should also be considered that if the patient is not autonomous, travel becomes even more burdensome, as there is a need for the
accompaniment of a family member or caregiver. An analysis of 471 telehealth delivered by five centers showed that only 15
percent of patients reside in the same municipality. Thanks to telemedicine, the remaining 85% of patients saved - between round
trips - an average travel (calculated using Google Maps services) in the order of 180 kilometers, for a time of more than two hours.
That is, at least half a day committed to a 30-minute visit. Assuming, by an optimistic estimate, that all cars are Euro-6 compliant,
the environmental impact can also be estimated, with an overall reduction of about 7 tons of carbon dioxide (CO2) emissions.
