An integrated POC solution for diagnosis and therapy monitoring of Heart Failure patients

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Project overview

Heart Failure

Heart failure (HF) is a life-threatening disease, causing a significant economic burden on healthcare systems across the globe. According to the European Heart Failure Association, the prevalence of HF is approximately 26 million patients worldwide and is increasing. Furthermore, HF is associated with poor prognosis, increased mortality and morbidity and frequent re-hospitalizations that pose a great problem for both patients and their families, as well as, the healthcare system. As the overall life expectancy has increased, the global community is now facing new challenges of improving quality of life and healthcare at affordable costs.

Prevalence

In Europe, the costs related to HF account for approximately 2% of the total healthcare costs and are mainly associated with the patient’s hospitalization costs . With an average patient hospitalization time of 11 days, the HF hospitalization cost is estimated approximately €23.000 per patient in the age group of 18-64 years old. Indirect socio-economic effects of HF disease include increased morbidity, disruptive productivity, increase medical debt and premature mortality.

Direct and indirect costs
 

HF diagnosis challenge

The process of HF diagnosis is challenging and complicated, since even if the pathophysiology of HF has been understood in great extent by the medical community, there is a wide spectrum of potential clinical manifestations of HF; signs and symptoms are often non-specific. The utilization of New York Heart Association (NYHA) Functional Classification system, as a tool to classify the HF patients according to the severity of their symptoms, introduces high intra-observer variability, since it is based on subjective evaluation. Additionally, therapy monitoring of the HF patients is of critical value for healthcare professionals and could assist in the identification of subgroups of patients that would benefit from a more intensive follow-up to avoid frequent rehospitalizations or delay disease progression to end stage HF. Currently the majority of HF therapy monitoring models are not personalized and suitable for clinical application. One has to agree that there is ample room for improving the usability of risk prediction tools and improve HF therapy monitoring.

New biomarkers and testing technologies, which can diagnose HF, monitor therapy and provide information related to the subsequent risk for adverse events and mortality of the affected patients may drive this change. Point of Care (POC) devices provide a great opportunity for continuous monitoring of such biomarkers. The POC market is driven by technological advancements for providing Micro-Nano-Bio Integrated Systems platforms (MNBS) that enhance the ability to detect, analyse and monitor biomarkers as evaluation end-points, with lower costs.

The KardiaTool platform

The aim of the KardiaTool project is to translate a laboratory proven concept of a saliva biosensor to the clinical practice for addressing the priority needs in personalized HF diagnostics and therapy monitoring at the point of care.

The KardiaTool platform includes:

  • An easy to use portable POC device (KardiaPOC) with a disposable Lab-on-a-Chip (LOC), for the non-invasive, rapid and accurate qualitative and quantitative assessment of HF biomarkers, from saliva samples. KardiaPOC device will integrate a variety of sensors, actuators, Microelectromechanical systems (MEMS), micro-electronics, bio-chemicals and functionalized magnetic nanoparticles (MNPs), onto a disposable, low cost LOC.
  • A decision support software (KardiaSoft) based on predictive modelling techniques, that analyzes the POC data and other patient’s data, directly added by the healthcare professionals, and delivers information related to HF diagnosis and therapy monitoring.

Background knowledge and R & D

KardiaTool objectives

 

KardiaTool objectives

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