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Wearable Wireless Kit for Detection and Monitoring of Ischemic Conditions

Final Report Summary - HEARTWEAR (Wearable Wireless Kit for Detection and Monitoring of Ischemic Conditions)

Executive Summary:
Heart ischemia is number one killer in the world (WHO, 2012). Ischemic Heart Disease (IHD) and its direct consequences is the number one cause of death in high income and middle income countries such as EU countries and the number four cause of death in low income countries; in 2008, IHD caused 7.25Mn deaths globally and a little over 1Mn in the European Region. In addition, IHD is the second leading cause of burden of disease (as measured in Disability-Adjusted Life Years or DALYs, or years of lost healthy life) in the high and middle income countries and number nine in low income countries; in the European Region, IHD is the number one cause of disease burden.

The biggest challenge with IHD is that between 70% to 90% of the episodes of IHD that can be detected with ECG are clinically silent, with patients unable to report symptoms like chest pain or discomfort. Currently, if an out-patient is suspected to have IHD, he or she is referred to the “stress test”. Stress test is relatively expensive in Europe, requires qualified medical assistance during preparation, testing and result interpretation and has a long waiting period (1-2 months). Critical in-patients are normally monitored with the continuous 12 lead ECG for 24-48 hours in the hospital in an even more expensive procedure.

Also a negative stress test will not always exclude coronary artery disease, because the test is done only within 10–20 minutes and not during patient daily activities. Therefore there is a need for easy to use, quick and affordable way for long term heart monitoring. The treatment for IHD is effective and it is possible to prevent myocardial infarct when the IHD conditions are discovered early.

HeartWear system was created to solve those challenges and to enable innovating today’s processes in the healthcare. HeartWear solution is easy to use, cost effective and provides quick results.

HeartWear developed a novel wireless product for preventive screening and monitoring of IHD that is able to monitor patient’s ECG during daily activities over a 24 to 48 hour period with quality of the SoA 12 lead ECG unit as a new type of ambulatory ECG that would cost less than 20% of the stress test. Innovative approaches are to include a truly wireless solution for patient convenience, patient positional information, information of breathing activity and tissue oxygenation as the need for automatic adjustment of continuous ECG signal for patient’s orientation during the cardiac cycle and adjustment for types of physical activity and irregular heartbeats have become the requirement by the medical community.

The HeartWear project is finished with good results –a fully functioning prototype system was developed and first results from clinical validation, where the ECG was recorded during exercise in healthy volunteers with both HeartWear and SoA 12-lead ECG systems, demonstrate that the quality of the ECG signals from both HeartWear and SoA 12-lead ECG systems was good and there were no significant differences between the systems.

SMEs behind HeartWear project are seeking for a partnership with a larger medical company in order to thake the HeartWear system to the market.

Project Context and Objectives:
The HeartWear project is finished with good results –a fully functioning prototype system was created and first results from clinical validation demonstrate that the quality of the ECG signals from both HeartWear and SoA 12-lead ECG systems was good and there were no significant differences between the systems.

The HeartWear system consists of four principal components:
• the disposable unit (DU) consisting of a flexible PCB with ECG leads integrated to plaster,
• the sensor unit (SU) taking care of recording patient signals,
• the main unit (MU) or belt unit recording and storing the data, and
• the server unit (software) to cover all processes needed for patient measurements by doctors and hospital personnel.

During the HeartWear project, system specifications were developed in WP1, followed by development of the hardware and software of DU and SU in WP2. At the same time, development of hardware and software for MU and server unit was done in WPs 3-4. The system was integrated and thoroughly tested in WP5. An ethical clearance was secured and two validation studies were done in volunteers.

During WP6, the system was demonstrated to SMEs and SMEs validated the system independently. SMEs are very happy with SU and DU professional design and aesthetic look as well as with MU reliability and the usability and functionality of the server unit. That was achieved by using a focus group of cardiologists during the project to make the product a good fit according to doctors’ needs.

SMEs prepared a detailed plan in WP7 for attracting a future partnership with a medical company to take the HeartWear system to the market. AXIO have begun serious negotiations with one of the world´s leading medical device suppliers, Covidien which has recently merged with Medtronic – another candidate in the SME partners’ shortlist.

A generic patent cannot be secured for such IHD monitoring device, since other similar patent applications that were submitted earlier, were not granted a patent. Nevertheless, this means that the HeartWear solution does not infringe on any existing patent and that the competitive markets can still be considered equal. Furthermore, there may well be some possibilities to patent narrow aspects of the HeartWear system, rather than the generic process.

Project Results:
1. Industrial design & prototype of the HeartWear disposable unit
2. Industrial design & prototype of the HeartWear sensor unit
3. Industrial design & prototype of the HeartWear main unit
4. Dedicated software prototype HeartWear sensor and main unit control, data processing and transmission
5. Dedicated software to support the communication protocol between HeartWear main unit, dedicated hub and patient medical record systems
6. Patent application on low-power integration of 7-lead ECG sensor(s), accelerometer /gyroscope sensor(s) and SPO2 sensor(s) for the purpose of IHD screening and CVD monitoring
7. Industrial design of plastic part for the disposable unit (including the mechanism to lock the sensor unit), casing for the sensor unit and casing for the main unit

Potential Impact:
HeartWear developed a novel wireless prototype for preventive screening and monitoring of IHD that is able to monitor patient’s ECG during daily activities over a 24 to 48 hour period with quality of the SoA 12 lead ECG unit as a new type of ambulatory ECG that would cost less than 20% of the stress test. Innovative approaches are to include a truly wireless solution for patient convenience, patient positional information, information of breathing activity and tissue oxygenation as the need for automatic adjustment of continuous ECG signal for patient’s orientation during the cardiac cycle and adjustment for types of physical activity and irregular heartbeats have become the requirement by the medical community.

The final result of the Heartwear project is a fully functional prototype that has gone through preliminary patient testing and evaluation of the recorded signals compared to other SoA methods like stress test exercise on bicycle/treadmill and Holter test. The major success factor of ECG V5 lead quality (since the ST segment of the V5 electrode is of the most informative for detecting IHD) was achieved.

Successful results of the project ensured a good platform for the Consortium of SME-s to either demonstrate the solution to a larger medical company who would help SMEs on taking the HeartWear product to the market, and also proceed with educating the key focus groups – cardiologists, GDP-s, government’s social system and of course – the end users.

The main results of the Heartwear project were:
1. Industrial design & prototype of the HeartWear disposable unit;
2. Industrial design & prototype of the HeartWear sensor unit;
3. Industrial design & prototype of the HeartWear main unit ;
4. Dedicated software prototype HeartWear sensor and main unit control, data processing and transmission;
5. Dedicated software to support the communication protocol between HeartWear main unit, dedicated hub and patient medical record systems;
6. Patent - unfortunately a generic patent cannot be secured, since other similar patent applications that were submitted earlier, were not granted a patent then. Nevertheless, this means that the HeartWear solution does not infringe on any existing patent and that the competitive markets can still be considered equal. Furthermore, there may well be some possibilities to patent narrow aspects of the HeartWear system, rather than the generic process;
7. Industrial design of plastic part for the disposable unit (including the mechanism to lock the sensor unit), casing for the sensor unit and casing for the main unit;

Heart Ischemia is number one killer in the world (WHO, 2012). One of the major problems with the Ischemic Heart Disease (IHD) is that around 70% to 90% of the episodes of IHD detected with ECG are clinically silent, with patients unable to report symptoms like chest pain or discomfort. When symptoms are detected, effective treatment exists by coronary angiography/PCI. There are also risk factors that require monitoring patients carefully and in a regular basis: heredity, smoking, hypertension, high cholesterol, obesity, inactivity, and especially diabetes mellitus 2. (Framingham risk stratification). The HeartWear system would be relevant to examine these patients in order to detect ischemia at an earlier stage, making it possible to open their coronary arteries and medically treat them before they are getting a myocardial infarction.

The impact of Heartwear product would be difficult to under-estimate, since every saved life is difficult to convert into Euros. We do foresee a major change of paradigms both in medical community and amongst patients, when this new technology will be employed and IHD screening will be easy, affordable and quick. Impact and saving costs on society will be remarkable. We see good financial benefit and opportunity for all SME-s from taking the product to the market.

List of Websites:
http://www.heartwear-fp7.eu/

The Coordinator:
Mr. Arild Hermansen
E-mail: arild.hermansen@axio.no
Tel: +47 916 01 745