Background

Healthy people think of the heart as a reliable pump that can have disastrous failures if we don’t manage our health. Good enough to last a lifetime, but easily damaged by bad choices with behavior, diet, and drugs. Using technology, we will improve our medical approach to cardiac care, improving lives, reducing costs, and avoiding bad outcomes.

Reactive Care is Bad

It is a terrible idea to wait for cardiac symptoms to develop before seeking the advice of a cardiologist, akin to waiting until you crash your car before ever checking the wear of tires and brakes. Waiting for symptoms is called reactive medicine and it results in many bad and sometimes irreversible outcomes, which could likely have been avoided. The solution is to switch to proactive cardiac care as part of a lifelong practice.

Dragorosso’s Vision

To make proactive healthcare convenient and simple, so that trends can be identified and handled long before irreversible damage results.  Our first product measures something new: Cardiac output, along with several other heart and lung performance parameters. 

History

Traditionally, cardiac output has only been measurable either by highly invasive catheterization of the heart, or with expensive equipment requiring an extremely skilled medical operator.  Our method consists of breathing normally for under a minute wearing a mask that covers your mouth and nose. While this technology will be available initially in hospitals and cardiology clinics, in a few years this will be a portable telemedicine device that will monitor heart patients in their daily lives.

Benefits

It’s hard to overstate the potential impact this will have in many medical roles; Cardiologists, pulmonologists, military doctors, burn specialists, intensivists and elite athletes will find our tool invaluable. This paper will focus on just one significant application of the technology: heart failure.

Heart Failure Complexity and Costs

Turns out, the heart in heart failure is far more complex and interlinked with other body systems than even leading experts in cardiology ever suspected. Much of the current understanding results from efforts in support of the current heart failure population of 6,200,000 patients, which is growing at 9% annually, costing US health systems and insurers over $40 billion each year, to try to provide heart failure patients with a reasonable quality of life. 

The Index Event

Just a few decades ago, if you had a ‘Heart attack,’ i.e., a Myocardial Infarction (MI) you might not expect to live much longer. With prompt medical care today, many MI survivors go on to live for decades after the event. Sadly, these survivors are more likely to develop heart failure, since the initial damaging ‘Index Event’ that sets a patient down the road to heart failure is often an MI. There are other index event types, but an MI is a prominent example. 

Why our bodies sometimes can’t heal MI damage

The body does have a heart healing process, and much research has been published on the subject. However, damage in the form of heart muscle cell death, from oxygen starvation during an MI, can overwhelm the limited regenerative capacity of the heart muscle. A complex progression ensues, whereby inflammatory and reparative responses come into play, which sometimes cannot perform satisfactory repair of damage from an MI. In summary, we didn’t evolve a dependable means of healing the heart after an MI. It’s easy to speculate why this is so. 

Modern medicine does care about post-MI recovery, which is likely to involve heart failure, so it’s up to us to understand heart failure and come up with effective therapies. Note that medical science is not giving up on using our innate reparative ability. Researchers are working on modulating the many processes to help the body heal itself with some assistance from us.

Hemodynamic Strategy

Since the heart is a pump, initial efforts used inotropic drugs to counter heart failure by improving hemodynamics i.e., making a heart in heart failure pump better. This approach has been discredited over the past few years as counterproductive, since efforts to get more pumping from a damaged heart accelerate degenerative changes. Among these are left ventricle enlargement and deterioration of muscle fibers, collectively termed ‘Remodeling,’ which worsen the condition, shortening survival.  

The body Fails to Help

To make things more complicated, in heart failure the brain and heart produce an array of hormones and other chemicals to try to restore cardiac output. Perhaps these chemicals are useful to the body in non-heart failure scenarios, but evidence shows these agents worsen long-term survival of heart failure sufferers by accelerating remodeling. There are efforts today to produce drugs aimed at blocking such agents. 

Complexity Makes Heart Failure Challenging

Many systems in the body are involved in the dynamics of heart failure. Combine this information with the fact that there are multiple types of heart failure, and it’s no surprise that we don’t fully understand it, which makes it hard to determine the best therapeutic course for even one patient. For now, we can focus on three things.  

The big three objectives: 

  • Slowing heart failure progression, 
  • Averting decompensation 
  • Reversing decompensation 

1) Therapy for slowing the progress of heart failure: This may employ a data-driven range of techniques to better understand how to minimize pulmonary hypertension and fluid buildup in each outpatient, plus an effort to prevent or slow down Left Ventricle (LV) remodeling, such as the neurohormonal approach: a proactive attempt to block the body’s unhelpful cytokine release and neuroendocrine activation. Beyond this, there are promising new surgical interventions aimed at avoiding the damaging high pressures which accelerate heart failure.

2) Averting decompensation / Acute Heart Failure and hospitalization: For each heart failure patient, put in place a system of Data Integration to combine historical data, baseline metrics and data from frequent monitoring of advance indicators of worsening HF, including:

  • Pulmonary Artery Hypertension correlates, such as Lung Diffusing capacity for Carbon Monoxide (DLCO) 
  • Fluid balance measurements
  • PA pressure trend measurements 
  • Other sensors or tests, such as for brain natriuretic peptide (BNP) 
  • Cardiac output 
  • Ambulatory blood pressure

This integrated data could drive a model for each type of heart failure, able to notify medical staff of the need for prompt intervention. Goal is to reach a 100% avoidance of admission for decompensation in the heart failure outpatient population.

3) Reversing decompensation: This in-hospital procedure will continue to involve diuretics and inotropic agents, to improve the heart’s pumping ability and to lower the high aorta and PA pressures, restoring a workable hemodynamic situation. Although these tools act counter to the longer-term goals of slowing LV remodeling, they remain the only currently effective means of saving lives and restoring decompensated patients to a state where they can be discharged to return to their home/outpatient lives.

Software to the rescue: The heart as a black box?

In the quest to identify the interdependencies between the multiple systems at play in heart failure, there is naturally a desire to research the whole picture via the scientific method, to rigorously confirm such understandings, eventually delivering full models for all the involved systems. That is the normal goal of research and is how all scientific progress is made. 

While this work will go on for many years as the frontiers of knowledge are expanded, an interim approach may yield useful results sooner. By using gathered and historical data to train Machine Learning software (ML) it may be possible deliver useful results in the following areas:

  • Monitoring outpatient telemedical information to produce prioritized candidate shortlists for intervention.
  • Actionable recommendations based on rich data for each individual patient
  • Automated continuous follow-up to learn about effectivity of the actions

Beyond saving labor and doing a better job of raising notifications and patient follow-up, we may be able to use ML to determine what therapy to use, without needing to understand the precise model of heart failure for each individual patient. This would mean treating heart failure and all related systems as one big black box with several modes of operation. 

What We Measure Today

We can measure Cardiac Output, DLCO, LCI and VO2 max parameters, accurately and non-invasively, using our face mask foreign gas breathing equipment. This equipment will ultimately be produced in a low cost, fully automated telemedicine version, which needs no medical supervision to use at home. 

We aim to add to the list of measurements with our own upcoming novel sensor technologies as well as through cooperation with other innovators. We expect to be able to measure trends in pulmonary artery pressure, or an equivalent noninvasively. For heart failure patients, the net result will be the ability to determine:

  • Performance of the heart
  • Performance of the lungs
  • The level of fluid buildup in the body and lungs
  • Whether pulmonary pressures are trending higher
  • Whether intervention is needed to avoid hospitalization, with a week’s advance warning

Conclusion

Dragorosso’s new Cardiopulmonary diagnostic will evolve to become the gold standard of proactive monitoring but will also be widely adopted in urgent cardiopulmonary situations. In support of the large heart failure outpatient population, the diagnostic will be at the core of data-driven care, through widespread deployment of affordable telemedicine devices. Our software will provide actionable suggestions for the patient and where permitted, will alert the patient's carer. The result will be too slow the progression of heart failure and avoid a large percentage of the damaging decompensation events. By using this approach, heart failure sufferers will live longer and better lives, and US health care systems and insurers will benefit by saving tens of billions of dollars annually.