How digital technologies can help patients with Congestive Heart Failure ?

Let us start with the basic understanding of what ‘heart failure’ means. The National Institute of Health, US, defines heart failure as “a condition that develops when your heart doesn’t pump enough blood for your body’s needs. This can happen if your heart can’t fill up with enough blood. It can also happen when your heart is too weak to pump properly. “Heart failure” does not mean that your heart has stopped. However, heart failure is a serious condition that needs medical care.”

Heart failure could be either a condition or a collection of symptoms that affect the regular pump of blood from the heart to the rest of the body, disrupting all major body functions. For some people with heart failure, the heart has difficulty pumping sufficient blood to support other organs in the body. Others may have hardening and stiffening of the heart muscles, thus blocking or reducing blood flow to the heart. 

Statistics

Global

The current worldwide prevalence of HF is 64.34 million cases (8.52 per 1,000 inhabitants), accounting for 9.91 million years lost due to disability (YLDs) and 346.17 billion US $ expenditure.

US

About 6.2 million adults in the United States have heart failure.

In 2018, heart failure was mentioned on 379,800 death certificates (13.4%)

Heart failure costs the nation an estimated $30.7 billion in 2012. This total includes the cost of healthcare services, medicines to treat heart failure, and missed days of work

• Approximately 550,000 new cases are diagnosed in the U.S. each year.
• Congestive heart failure affects people of all ages, from children and young adults to the middle-aged and the elderly.
• Almost 1.4 million persons with CHF are under 60 years of age.
• CHF is present in 2 percent of persons aged 40 to 59.
• More than 5 percent of persons aged 60 to 69 have CHF.
• CHF annual incidence approaches 10 per 1,000 population after 65 years of age.
• The incidence of CHF is equally frequent in men and women, and African-Americans are 1.5 times more likely to develop heart failure than Caucasians.
• Heart failure is responsible for 11 million physician visits each year, and more hospitalizations than all forms of cancer combined.
• CHF is the first-listed diagnosis in 875,000 hospitalizations, and the most common diagnosis in hospital patients aged 65 years and older.
• In that age group, one-fifth of all hospitalizations have a primary or secondary diagnosis of heart failure.
• More than half of those who develop CHF die within 5 years of diagnosis.
• Heart failure contributes to approximately 287,000 deaths a year.
• Sudden death is common in patients with CHF, occurring at a rate of six to nine times that of the general population.
• Deaths from heart failure have decreased on average by 12 percent per decade for women and men over the past fifty years

Source: Heart Failure Statistics.

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CHF Classes according to the severity of symptoms

Doctors usually classify patients' heart failure according to the severity of their symptoms. The table below describes the most commonly used classification system, the New York Heart Association (NYHA) Functional Classification. It places patients in one of four categories based on how much they are limited during physical activity.

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For Example

• A patient with minimal or no symptoms but a large pressure gradient across the aortic valve or severe obstruction of the left main coronary artery is classified:

             - Function Capacity I, Objective Assessment D

• A patient with the severe anginal syndrome but angiographically normal coronary arteries is classified:

             - Functional Capacity IV, Objective Assessment A

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We can imagine a funnel regarding the number of patients at each severity level. There are more in Class I than in Class II, more in Class II than in Class III, and more in Class III than Class IV. We understand that the level of medical attention and treatment required for each stage will be different. When we look at chronic diseases, we think about how we can reduce the patient progressing from less severe to more severe class and trying to reverse from more severe to less. And we believe that digital health technologies can play a crucial role in making that happen.

According to the National Institutes of Health, the risk factors for CHF are age, family history and genetics, lifestyle habits, other medical conditions, race or ethnicity, and sex. Among the risk factors, lifestyle habits are the ones patients can control. 

The American Heart Association defines ideal cardiovascular health based on seven risk factors (Life's Simple 7) that people can improve through lifestyle changes: smoking status, physical activity, weight, diet, blood glucose, cholesterol, and blood pressure.
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We know that we only improve what we measure. Before smart wearables were available, effectively measuring our daily habits and activities was impossible. But come today, people can measure their vitals and calibrate their health based on measurements taken conveniently through easily accessible wearables and wellness devices. They can create a positive feedback loop by measuring, acting, and improving health. For example, today, anyone can measure their resting heart rate using off-the-shelf wearable devices such as Apple Watch, Fitbit, or cheaper fitness devices readily available on the market for less than $20.    

Resting heart rate is inversely correlated to cardiovascular health. If you start doing any aerobic exercises such as walking, running, or High Interval Intensity Training ( HIIT), you can observe that the resting heart rate progressively declines, which signals an improvement in the cardiovascular system. So, anyone motivated can use these measurements as a guide to improving cardiovascular health. 

Wearable data also facilitates real-time behavioral change techniques (BCTs), such as just-in-time adaptive interventions, designed to dynamically assess user needs and provide the appropriate amount and type of intervention at the appropriate time. Several trials were designed to assess the benefits of wearable-guided BCTs.

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Not everyone is a scientist. Still, wearables have created the opportunity for everyone to become scientists of their own accord with the sample size of one, or maybe more if friends and families are involved. That’s where the opportunities arise for digital healthcare companies to create preventative and wellness devices and service models. The rise in the wellness industry and direct-to-consumer preventive health care companies are the solution to the challenges. Although it’s early, we have to see how it plays out in the future.

Nevertheless, it’s an exciting opportunity.

About four-in-ten Americans approve of fitness tracker data being used for heart disease research

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Around three-in-ten Americans living in households earning $75,000 or more a year (31%) say they wear a smartwatch or fitness tracker regularly, compared with 12% of those whose annual household income falls below $30,000. Differences by education follow a similar pattern, with college graduates adopting these devices at higher rates than those who have a high school education or less, according to a survey of 4,272 U.S. adults.

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There can not be any compromises with the data generated from consumer-grade wearables and trackers when it comes to healthcare. From measuring every heartbeat to finding out the blood pressure level, wearable wellness devices need to be precise to aid the patients in their preventative or recovery journey. Given that the technologies surrounding wearables and home-based wellness devices are relatively new and extensive research surrounding their efficacy is yet to be done, there is enough preliminary evidence supporting their usefulness. 

One study that investigated the accuracy of the Apple Watch 3 (Apple, USA) and the Fitbit Charge 2 (Fitbit, USA) showed that both devices provided an acceptable PPG sensor HR accuracy (<10% mean absolute percent error) across 24hrs and during various activities, including sitting, walking, running and activities of daily living (such as chores or brushing the teeth). Overall, these findings provide preliminary support that these devices appear to help implement ambulatory measurement of cardiac activity in research studies, especially those where the specific advantages of these methods (e.g., scalability, low participant burden) are particularly suited to the population or research question.

Weight biosensors 

Biosensor-based devices are pioneering in modern biomedical applications and will be the future of cardiac health care.

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People can monitor their health, vitals, daily activities, and other risk factors at home and use the measurements to recalibrate their health. But it is easier said than done. Like every new technology, wearables and wellness devices have a long way to go before being incorporated into the general people’s daily lives. 

The seven risk factors mentioned earlier need significant lifestyle changes that require sustained behavioral change. Many studies show that a habit change is difficult to execute for most people, and following through with the changes is even more challenging. Even with the wearable-guided BCTs (behavioral change techniques), the patients maintaining behavioral changes for the long term is a matter of concern for developers and healthcare providers. 

A recent trial with 800 participants questioned the value of wearables in sustaining long-term behavioral changes and improving clinical outcomes, coming to a conclusion that “an automated tracking‐texting intervention increased physical activity with, but not without, the texting component. These results support new mHealth tracking technologies as facilitators in need of behavior change drivers.”

In another study, participants with obesity were given a Fitbit One to wear, to monitor the number of steps they took every day. A random selection of 50% of the participants was sent daily text message prompts as reminders. During the study, the group receiving the text messages showed an increase in the number of daily steps. This effect, however, started fading after the first week and was not sustained over the 6-week study period. 

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The introduction, implementation, and continuity of telehealth services and related wearables is a battle for all stakeholders, the prospective patients included. Acceptance and adherence cannot be forced into people’s lives and day-to-day activities. Instead, it is most effective if the consumers take it upon themselves to apply these practices in their lives without daily external intervention.

Fortunately, there are ways to improve acceptance and adherence to change of habit while building new digital products. Some of them are as follows:

1. Just in Time Adaptive Intervention (JITAI) 

• In the case of chronic diseases like CHF, external intervention at the right time, at the right place, and in the proper context can support the continued use of consumer-grade wellness devices in patients. This is possible through the concept of just-in-time adaptive intervention (JITAI). By adapting to each individual’s changing internal and contextual state, JITAI provides chronic patients with the right type and amount of support. In cases where these patients’ state changes rapidly and unexpectedly, JITAI eliminates the need for physical intervention by making the use of mobile devices and technologies.

JITAIs have been implemented, and pilot tested in several domains of health behavior change. A report published in the International Journal of Behavioral Nutrition and Physical Activity defines JITAIs as having three features: behavioral support that directly corresponds to a need in real-time; content or timing of support is adapted or tailored according to input collected by the system since support was initiated; support is system-triggered.

With crucial evidence, the report also informs that the adoption of JITAIs in health and care systems has more added value than telehealth interventions without just-in-time messages. Studies in the report reinforce the assumption that JITAIs deliver support when users are most likely to be receptive.

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2. Personalized coaching or accountability partners    

How often have we seen our friends and acquaintances benefit from hiring a personal trainer or yoga guru? Or friends who hold each other accountable for their lifestyle changes and come through most of the time? Self-motivation is one thing, but when you have an urgency to change your habits and lifestyle, having a personalized coach or accountability partner helps you make those changes and stay on track to get results. 

Similarly, in cases of chronic diseases like CHF, getting help from personal health coaching and accountability partners has proven to optimize adherence for the patients. But physical one-on-one sessions further add to the already heavy burden for chronic patients both logistically and economically. 

In this scenario, telehealth services are using this as an opportunity to cater to the patients by providing them with personalized healthcare services at affordable costs. 

Self-care management education is one of the European Society of Cardiology recommendations given to reduce the readmission rate of patients with heart failure (HF). According to a study published in The Journal for Nurse Practitioners, health coaching has a positive potential in making education effective to improve patient outcomes. Furthermore, psychological/social support actors, including doctors, nurses, caregivers, family members, or friends, play a critical role in intriguing patients to participate in health interventions, US-based virtual care platform Vida Health, which provides personalized healthcare programs to thousands of patients, has announced a new app-based, coach-centered virtual congestive heart failure (CHF) management program set to launch in December 2021. “Vida’s unique approach to CHF addresses the challenges of this condition and its co-occurring nature with chronic conditions such as long-standing hypertension, hyperlipidemia, and diabetes,” the company states. 

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3. Gamification

Gamification, i.e., adding game mechanics into nongame environments, is one of the most used strategies in increasing and ensuring user participation in all things tech. 

From e-commerce giants like eBay to smaller companies offering products and services online, gamification is an essential digital marketing tool in today’s world. 

The gamification strategy—where the users’ progress and improvement can be measured, realistic goals can be set, and a sense of competition with self or a group can be created and incentivized—is equally applicable and used in telehealth practices. The gamification of something as basic as walking encourages thousands of people to adopt a healthier lifestyle. Let’s look at the “10,000 steps a day” challenge initiated by the CQUniversity, Australia. 

A report titled “Gamified applications for secondary prevention in patients with high cardiovascular disease risk: A systematic review of effectiveness and acceptability” concludes that gamified mobile apps show the potential to improve secondary prevention in high cardiovascular disease risk patients. Indications for acceptability were evident, with higher adherence than clinic-based secondary prevention programs. 

Furthermore, there are other institutional ways to improve the habit.

1. Insurers can reduce premiums to those who show improvement in those risk factors
2. Employers can foot the bill required for telehealth consultations
3. Governments can reimburse providers that help their patients improve those risk factors.

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We have shown many studies that show the benefits of digital technologies such as wearables, RPM, and telehealth to prevent Heart failures for early-stage patients, reduce progression rate for less severe patients, and enable living confidently for severe patients. 

However there are studies such as the study titled” Effectiveness of Remote Patient Monitoring After Discharge of Hospitalized Patients With Heart Failure: The Better Effectiveness After Transition–Heart Failure (BEAT-HF) Randomized Clinical Trial” concluded that “among patients hospitalized for HF, combined health coaching telephone calls and telemonitoring did not reduce 180-day readmissions.”

At the same time, there are studies such as titled “The role of non-invasive devices for the telemonitoring of heart failure patients” concluded that “results show that non-invasive telemonitoring can lead to an improvement in prognosis and a reduction of hospital admissions in high-risk patients.”

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There are so many opportunities, but we are yet to see how the institutional changes play out at this point in time. We understand that these are complex matters, and they will take time. In the meantime, we can build new health technologies to enable patients to adopt and adhere to new habits so that their disease does not advance to the severity class. 

At the baseline, we see the opportunity of using wearable technology, remote patient monitoring, and telehealth for disease prevention and cure. We want to elaborate further on how technology can help more severe conditions. Let us see how technology can help the most common challenges for CHF patients.

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Early screening is expensive and time-consuming for Stage B patients. Imagine a scenario where a Stage B patient has chest pain, shortness of breath, and fatigue. Most patients are known to ignore the symptoms till they get worse. Now, what if the clinicians can reach out to the patients based on vitals such as a sudden increase in resting heart rate, decrease in blood oxygen level, increase in the wake-up time during the night, and decrease in activity rates?

Previously, humans would have to keep monitoring all of these and update the results manually. That constant need to monitor vitals every day and for several hours in the day was expensive and time-consuming. But now, we can outsource these monitoring needs to technology so that patients get proactive screening instead of reactive screening, and clinicians can advise patients to take corrective measures to prevent progression and even reverse the progression of chronic diseases. If the patient and clinicians can intervene early, the patient can perhaps be prevented from progressing to the severe stages.

Some of the technology solutions for early screening can be as follows:

1. Alert when vitals fluctuate. 

The system notifies the clinicians and the patients whenever important vitals go up or down. In this case, machine learning algorithms to predict or diagnose are not required. Instead, real-time data is generated depending on the patient's physical state. This type of system is possible because of wearable technologies. We can get longitudinal data of each patient rather than cross-sectional data. The alert threshold can be personalized according to each patient. We will explain this more in our next article.

Longitudinal vs cross-sectional data (research)

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2. Machine Learning Prediction

Algorithms have taken over the technology world as machines learn to identify the patterns in user behavior and turn them into data that can predict or forecast future behaviors. Social media applications like Facebook and TikTok heavily rely on algorithms to feed their machine with intelligence on their users' behaviors and patterns. 

In the context of telehealth, when we have longitudinal data on each patient, it is possible to build more advanced algorithms that can predict heart failures, and also help take interventions that could prevent heart failure. Alternative therapies for patients and further improved care can be done by using a novel systems biology approach that incorporates demographics, biomarkers, genome-wide analysis, and proteomics to develop a model that predicts response to therapy.

Further, a study titled “Machine Learning Applications in Heart Failure Disease Management: Hype or Hope?” concludes that machine learning approaches can be used to develop risk scores that are superior to ones based on standard statistical methods. However, careful attention to detail in curating data, selecting covariates, and troubleshooting the process is required to optimize results.

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We know that invasive implantable devices such as CardioMEMS can be used for severe patients at Stage C or Stage D. Recent data suggest that CardioMEMS devices lower mortality in heart failure patients and also reduce the risk of recurrent hospitalizations in chronic heart failure patients.

However, since CardioMEMS is an invasive device, the access is restricted to severe patients. Patients who have the authorization for the implant can afford the upfront cost (average $188,000 including device and implantation for a 5-year observation period), and are willing to take some risks have been using the device. This leaves the rest of the patients with heart conditions vulnerable.  

We think that just because patients are ineligible does not mean they should not get access to continuous monitoring for accurate diagnosis and detection. We have been mentioning in this article that non-invasive, off-the-shelf wearable sensors can be used to accurately diagnose and detect heart failures at lower costs and convenience for the patients. .

As a reference to the efficacy of wearables and their positive effects on chronic patients, a study titled “Continuous Wearable Monitoring Analytics Predict Heart Failure Hospitalization” concludes that “Multivariate physiological telemetry from a wearable sensor can provide accurate early detection of impending rehospitalization with a predictive accuracy comparable to implanted devices.” Another study titled “Remote Monitoring of Patients With Heart Failure: An Overview of Systematic Reviews” concludes that telemonitoring and home telehealth appear effective in reducing heart failure rehospitalization and mortality.

Non Invasive smart wearables devices and their cardiovascular applications.

We think that anyone can live a high quality of life. It is about living confidently even with the disease and not exasperating over the risks. Even for a patient living with severe CHF, there are many ways the patient can live confidently with the disease. Digital health technology can enable that quality of life. Let us go through how digital technologies can solve massive challenges in delivering that care.

Medication and treatment adherence

Doctors and nurses should know whether their patients are following medication and treatment recommendations or not. The task sounds simple on paper but most doctors and nurses we talked to talk about blind spots and how they do not have visibility of whether the patients are adhering to medication and procedures or not. 

We empathize with the patients. All of us have been patients at least once in our lives. When we are ailing, we do not wake up early in the morning, take timely medications, or get engaged with technology. And when we are severely ill, we need help. That is where external accountability of friends, family, caregivers, and telehealth services can enhance adherence. 

We understand that just a smartphone application for patients to actively upload their medical and treatment adherence is an incomplete solution. Indeed, we need to develop apps that are user-friendly, easy to enter data and encourage patients to adhere. But human intervention is also required in care. Digital tools such as smartphone apps and augmented telehealthcare services can improve medication adherence. We will show in our next article how we can design systems that patients can conveniently adapt to their daily lives.

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Continuous patient education and engagement

We believe that there is a right time to educate patients about their diseases. The right time actually is continuous education and not just crash courses during patient admission and discharges at clinics or hospitals. Patients should have the option of knowing about the symptoms, managing those symptoms, and getting access to early and continuous information regarding the diseases they are suffering from. 

As we discussed above, patients can know about the correlation between their symptoms and readings of the vitals and recalibrate their habits using those measurements as a guide to managing their symptoms. For this,  they would need continuous guidance and education which only a digital companion can provide at low costs and with precision. Furthermore, when their symptoms can be exacerbated they would need expert guidance which telehealth services can provide instantly without wasting time, and when necessary home service can deliver care. 

We think that a hybrid model of telehealth plus remote patient monitoring and physical services at home or clinic can help educate the patients and help them prevent or recover from chronic diseases.

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Clinical team collaboration

We have seen many times that CHF patients tend to have multiple comorbidities. Their care team has many different stakeholders and specialists. We have seen that when cardiologists recommend a certain treatment, it may have adverse impact/s on other organs such as kidneys and liver. Therefore, each specialist treating the patient must know about all the diseases the patient has. It sounds obvious to state but many times, we have seen this not happening because of the lack of a single source of truth where everyone finds the information and updates the information for others to see. 

This is why many hospitals use the “Heart Team Approach” to treat heart failure patients. We believe that digital technologies can help improve the Heart Team’s performance.

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Create a single source of truth

Patients engage with many specialists for treatment and these specialists can have multiple electronic health record  (EHR) systems. We can create a dashboard that integrates and pulls together the patients’ data from their  EHR. Not only that, but we can also show a dashboard of analysis of patients’ data collected through remote patient monitoring.

Then, within that single source of truth, we can also design a collaboration workflow among all stakeholders. In short, we are advocating for a patient-centric system rather than a siloed system where each system is designed to optimize the local maxima of that specialist’s office. 

Severe patients will need invasive implantable devices to live. Our position is that by early screening, and early detection using wearables, RPM, and telehealth, we can give more people better access to CHF care. 

List of Implantable Devices:

• Implantable cardioverter defibrillator (ICD)

• Some people who have severe heart failure or serious arrhythmias (irregular heartbeats) may need implantable defibrillators or ICDs. These devices are surgically placed and deliver pacing – or an electric countershock – to the heart when a life-threatening abnormal rhythm is detected. ICDs have saved millions of lives, but are only advisable in certain circumstances. The decision to use an ICD is a shared one by the physician and patient.
• Cost: Estimated at $30,000 to $50,000; excluding physician and anesthesia fees
• Risk: confer risk for delivery of unexpected painful shocks during the dying process
• It is estimated that more than 650,000 people in the United States currently have implanted cardiac devices (ICDs) designed for defibrillation.

• Cardiac Resynchronization Therapy (CRT)

• Some people with heart failure develop abnormal conduction of the heart’s electrical system that changes how efficiently the heart beats.

In such cases, cardiac resynchronization therapy (CRT), also known as biventricular pacing, may be needed. In this procedure, a special pacemaker makes the ventricles contract more normally and in synchrony.

This therapy can improve heart function, reduce hospitalization risk and increase survival.

• Cost: CRT, CRT-D, and ICD devices related cost in US dollars, is $ 17,982, $ 36,153, and $ 23,317 respectively
• Risk: CRT is not considered a major or dangerous type of procedure. But like all surgery, it carries some risks. They include

• Reaction to the anesthesia
• Swelling or bruising in your upper chest area where the CRT device is placed
• Bleeding, including bleeding from the heart
• Infection
• Heart rhythm problems
• Movement of the device or the device wires that may require a second surgery
• Mechanical problems with the CRT device
• Worsening of kidney function
• Collapsed lung (pneumothorax)
• Frequent hiccup sensation or twitch from the wire on the left side activating the nerve to your diaphragm. This is called diaphragm stimulation. It can typically be fixed with programming changes to your device.

• Left ventricular assist device (LVAD)

• The left ventricle is the large, muscular chamber of the heart that pumps blood out to the body. A left ventricular assist device (LVAD) is a battery-operated, mechanical pump-like device that’s surgically implanted. It helps maintain the pumping ability of a heart that can’t effectively work on its own. These devices are available in most heart transplant centers.
• Cost: The mean cost of LVAD implantation was $175,420.
• Risk: 

• Bleeding. Gut. Brain.
• Clot.
• Stroke.
• Infection.
• Right heart dysfunction.
• Hemolysis. Damage to blood cells due to the pump.

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List of Invasive Devices

• CardioMEMS

CardioMEMS™ HF System is the only remote monitoring platform for both HFpEF and HFrEF patients clinically proven to

• aid physicians in preventing worsening heart failure
• lower mortality rates
• improve quality of life

As telemedicine becomes more common, the CardioMEMS HF System is a safe, reliable way to help patients manage their heart failure.

The CardioMEMS HF System offers real-time notification of patient changes and simple, convenient access to secure data for proactive, personalized patient management. It also provides patients with a heightened awareness of the factors affecting their health and a powerful sense of control.

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We understand that the use of digital technologies such as wearables, remote patient monitoring, and telehealth are relatively novel concepts. But based on the trajectory of growth we have been witnessing, we predict that we will have greater adoption of these technologies in the future. We can also predict that these technologies will get better because we can innovate and invent new technologies. People that are different levels of severity will use digital healthcare technology that is suitable for them to prevent or reverse the disease or live a quality life with the help of those innovations. 

The next article will demonstrate a digital health technology that helps severe CHF patients get continuous connected care at home.