D-Heart Covid-19 kit for homecare use

COVID-19 is shutting down Europe, with an unprecedented effect on all aspects of daily life. Health and healthcare are being impacted in a seismic way. Undoubtedly, COVID-19 will challenge us all more than any other healthcare issue in living memory.

We are proposing the use of the hospital-level D-Heart ECG in combination with digital thermometer and pulse oximeter connected to the D-Heart app on the smartphone. In this way we can provide the best solution for homecare visits of elderly patients and for the monitoring of the QT interval in COVID-19 patients and checking the health conditions in chronic patients.

This approach would limit hospitalization to a focused target of disease severity, thereby decreasing contagion, protecting patients and health care workers, and minimizing consumption of protective equipment.

We are targeting Italy and in particular one of the most affected region from Covid-19: Lombardia. 

The targets we want to reach with our solution are: general practitioners, nurses and    caregivers, who can be equipped with the D-Heart ECG in combination with a digital     thermometer and a pulse oximeter for homecare visits to COVID-19 patients and chronic         patients. Our Covid-19 kit can be used also by patients, who in total autonomy can register     ECGs at their home, thanks to the D-Heart App, which guides the user in performing the           exam step by step. Once the ECG is registered, patients can check also the body            temperature and the SpO2 level, then they can easily share in one PDF all the measurements (collected with the three devices) with their general practitioners or      they can send the exam to our telemedicine service active 24/7 for a complete check up of   their health conditions.

D-Heart Covid-19 Kit  is made up by three devices: an 8/12 lead ECG which connects to tablets and smartphones via Bluetooth and guides the user step by step in performing a hospital grade electrocardiogram everywhere and anytime thanks to the App D-Heart, a digital thermometer to check the body temperature (contactless) and a digital pulse oximeter to check the blood oxygenation.  

Niccolò Maurizi, co-founder and Chief Medical Officer of D-Heart, is now working in a hospital on the front line against Covid-19 and he has realized how is fundamental for patients to avoid going to the hospital. With Telemedicine a doctor can modulate the remote drug therapy of the chronic patient, avoiding to clog the health structures already in difficulty in containing this emergency.

We are addressing our solution to all health professionals who are providing homecare visits and assistance to Covid-19 affected patients, like general practitioners, nurses and caregivers in Lombardia, Italy.

Our kit is perfect for health professionals because it is:

-       Portable, it weighs only 300 gr

-       Easy to use

-       Easy to sanitize

-       The ECG telereporting system is provided within 15 minutes by San Raffaele hospital (in Milan) cardiologists

·      The problem relates to the Challenge because it represents the necessity to avoid patients to go to the hospital for monitoring their health status;

·      The solution relates to the Challenge because it strengthens access to affordable primary healthcare services directly at patient’s home and enhance disease surveillance monitoring, it improves healthcare supply chains as well;

·      The target population relates to the Challenge because health professionals like general practitioners and nurses are always in the first line against systemic diseases like Covid-19.

D-Heart is the only ECG solution certified for homecare use able to diagnose myocardial ischemia from home. This is possible because our solution is not a 1/2/4/6 leads ECG solution but an hospital grade ECG solution with 8/12 leads so thanks to our setting the cardiologist can always evaluate the ST evaluation something that is not possible to do if you don't have precordials electrodes like in a case of a 1/2/4/6 leads ECG solution. So we are focusing  mainly on ischemia heart condition and heart failure market, than for sure having 8 and 12 leads give to the clinician the possibility also to diagnose easily all the types of Arrhythmias. There are thousands of 1, 3,4,6 leads ECG for example: Alivecor Kardia, Qardio Qardiocore, Apple Watch.

D-Heart is using the classic 8 or 12 lead ECG, measuring all the precordial leads and peripherals, without changing the classic positioning of the electrodes that cardiologists know. Cardiosecur is using orthogonal Frank Leads, which reconstruct all our derivations, including all the precordial ones. This methodology of performing an ECG , as seen from the references attached here: https://www-sciencedirect-com.ezproxyberklee.flo.org/science/article/abs/pii/S0022073608002665 or https://www-sciencedirect-com.ezproxyberklee.flo.org/science/article/abs/pii/0002914966903791, has been abandoned since the early 70s for multiple reasons, including poor reliability in the case of pathological ECG (where instead good comparative performance for normal ECG). Unfortunately, these are not recent references, as it is a topic now outdated in the scientific cardiological debate.

We developed a new concept of an existing technology. The traditional ECG machine are expensive, bulky and difficult to use, the misplacement of the cables makes the exam not reliable. With our patented solution we make the ECG affordable (it costs 10 times less), portable, easy to use and clinically reliable. Everyone can perform a hospital grade ECG anywhere and anytime with your smartphone or tablet, thanks to the App. A patented algorithm recognizes the chest of the patient and show the picture of his/her chest with colored marks, following this picture the patient can place correctly the colored cables. D-Heart App allows to connect the smartphone to the device thanks to the Bluetooth technology and permits to receive the telereport in max 15 minutes from the telecardiology service, directly to your email and App. D-Heart has definitely revolutionized the ECG system and this was recognized by many subjects (considering the prizes and awards won), including Forbes, which identified the Co-founders among the most influential under 30 in the healthcare sector.

In few years we sold 2830 units in the 5 continents, we signed exclusive distribution agreements in 25 countries, and we are now working to sign other agreements in 5 countries. The Covid-19 epidemic has highlighted the importance of the telemedicine and we are providing the possibility to integrate our solution to other Apps, systems and software to private and public entities worldwide.

This is our product demo video (12 leads for health professionals): https://vimeo.com/325609227

This is our product demo video (8 leads for patients): https://vimeo.com/262982038

Bergamo is the town most affected by the COVID-19 epidemic, not only in the Lombardy Region but also throughout Italy.

Physicians Mirco Nacoti, Luca Longhi, and their colleagues at Papa Giovanni XXIII Hospital in Bergamo, published a paper in NEJM Catalyst, a new peer-reviewed journal from the New England Journal of Medicine claiming that: “Western health care systems in Italy have been built around the concept of patient-centered care, but a pandemic requires community-centered care.” So, we believe that managing patients at home is a brilliant thing and that could be augmented by mobile clinics and telemedicine. This initial experience is revealing interesting aspects to be investigated in the near future, such as the reduction of admissions for cardiovascular emergencies, such as ST-segment elevation myocardial infarction (STEMI), non-STEMI, and acute heart failure (possible explanations can be that patients are afraid of being infected by COVID-19 in hospital, the difficulty in calling for ambulances and Emergency Services, or lifestyle changes); the increase of pulmonary thrombo-embolic events; the difficulty of the differential diagnosis in patients with interstitial pneumonia and heart failure; and, finally, the role of the heart in the high mortality rate of these patients. By reducing the number of patients admitted for urgent cardiovascular events, an increase of cardiovascular mortality in patients who prefer to stay at home and a sudden, more significant increase in hospitalization for cardiovascular events, especially for heart failure, are likely to be expected immediately after the end of this pandemic, which we should certainly be prepared for.

Furthermore, drugs therapy used for the treatment of COVID-19 infection, i.e. chloroquine / hydroxychloroquine, lopinavir / ritonavir (SIMIT, 13/03/20) significantly increased ventricular lengthen repolarization (QT interval increased in the ECG), with the potential risk of lethal arrhythmias for patients. We are proposing the use of the hospital-level D-Heart ECG smartphone-based device for homecare visits of elderly patients and for the self-monitoring of the QT interval in COVID-19 patients being treated with these drugs. For these reasons we decided to create “the Covid-19 kit for homecare use" made up with: -D-Heart ECG + digital thermometer and SpO2 pulse oximeter.

Currently we are serving more than 2000 people, in one year we will serve 4000 and in five year 10.000, but the solution will directly and meaningfully affect more people, in fact, if for example the device is used by a general practitioner in his/her studio or for homecare assistance, it will be affect also his/her patients.

One of the main goals is to integrate D-Heart into the company's health and welfare policies.

Given that the two main causes of death in the world are two heart diseases: heart attack and stroke, we are also working to create new life policies, TCM and Long-Term Care with the D-Heart device and service included in the policy. In this direction we are collaborating with Europ Assistance and Generali, to organize "The Heart Days" in which it offers the opportunity for Generali customers to learn about the product and obtain a free ECG screening with blood pressure measurement and nutrition advice for the cardiovascular prevention. All these initiatives are in a sense an intermediate step to show people that if they can do an ECG with D-Heart in the agency or bank, they can also do it at home in complete autonomy. The next step will be to get to the patient's home, through health and life insurance policies. In the world there are already virtuous cases of this type that demonstrate how the health policies in which the person is encouraged to maintain correct lifestyles, through small daily actions (going to the gym, walking, eating healthy, sleeping regularly), and offering 'rewards' based on the results achieved, such as the discount the following year on the policy, are a winning model. Empowering the person to take care of himself is the only efficient way to reduce any health care costs and to do serious prevention.

Basically, the barriers are to convince people that the telemedicine is a great solution to monitor the health and become an engaged partner in the management of his/her own health. Covid-19 situation has highlighted its importance, but we need more efforts from public institutions, to implement solution like ours to the public healthcare system.

Basically, the barriers are to convince people that the telemedicine is a great solution to monitor the health and become an engaged partner in the management of his/her own health. Covid-19 situation has highlighted its importance, but we need more efforts from public institutions, to implement solution like ours to the public healthcare system.

Full-time staff:

-Nicolò Briante, CEO and Co-founder

-Niccolò Maurizi, MD and Co-founder

-Marzia Casazza, Customer Support

-Filippo Bassi, Logistics

D-Heart biomedical start-up was founded in 2015 thanks to the work of Nicolò Briante and Niccolò Maurizi, at the time two young students in the interdisciplinary environment of the Almo Collegio Borromeo of Pavia. Maurizi is a young doctor researcher in cardiology at the University of Florence. When he was sixteen, Maurizi was hit by a myocardial infarction. He decided to became a doctor and transform his problem into an opportunity. Thanks to the help and business expertise of his roommate, Briante, they created D-Heart, the first smartphone ECG device that combines the usability required by the patient and reliability of the ECG wanted by the doctor. Now Maurizi is a doctor in Switzerland in Hospital du Valais Romand and researcher in Cardiology at University of Florence. He was in the first line against Covid-19 epidemic and he acquired a lot of experience. Briante is graduated in Business Law and he is the CEO of D-Heart.

We provide to healthcare professionals our product and its related services, through local distribution organizations, which know well the medical device market and the healthcare system.

We fund our work selling our solution and its related telecardiology service.

We are applying to solve because we’d like to give the possibility to health professionals (GPs, nurses and caregivers) to have a Covid-19 Kit in Bergamo Area, the most affected area in Italy for homecare assistance to patients.

We also are interested in receiving training, advice and partners about our product distribution abroad. Every Country has a different healthcare system and knowing well it, is the key to arrive to healthcare system and patients there. For example, some countries have the possibility to give refunds to patients for primary exams like ECGs.

 We need advice and suggestions from local partners on how to register our class IIa medical device, to know well the local healthcare system and partners to distribute our solution.

  We are looking for medical device distributors with experience in distributing medical devices to their community to start our partnership for the commercialization of our product.

Mobile health (m-Health) technologies are revolutionizing cardiovascular (CV) medicine. However, more than 80% of heart disease related deaths occur in developing countries, that are unable to take advantage of such innovations for healthcare awareness and prevention. With the rise of non-communicable diseases there is an urgent call to promote effective and accessible low- cost prevention campaigns in low-income setting. While high-income countries remain at the forefront of developing the latest mobile technologies used in healthcare, the rate of penetration of such technologies in low-and-middle-income countries has recently exceeded that of their wealthier neighbours. In general low-and-middle-income countries have major restrictions on their healthcare capacities due to the lack of infrastructures, human resources and logistics. Smartphone technology may overcome several of these limitations by providing an easy and affordable access to accurate diagnostic and monitoring methods. In such setting, widespread availability of accurate ECG screening would represent a major step in the right direction

With D-Heart we are active worldwide in affordable and operator-oriented cardiovascular screening campaigns, partnering with NGOs, private foundations as well as benefit corporation.