What is Heart Failure?

Heart failure, or congestive heart failure, means that the heart muscle is unable to pump enough blood to meet the body’s needs for blood and oxygen. This can cause shortness of breath, persistent coughing or wheezing, buildup of excess fluid in body tissues, and fatigue.

Heart failure is a chronic, progressive disease state that tends to worsen over time. It is estimated that patients over 65 years of age and who were hospitalized for heart failure have a 5-year mortality rate of 75%. Their median survival is also markedly lower than the life expectancy of individuals in the United States (e.g., for age 65 to 69 years, medium survival was ≤4 years vs 18.7 years, respectively).

There is usually no cure for heart failure, but for people with mild to moderate heart failure symptoms, it can be managed with lifestyle changes and medications. However, in patients with severe heart failure symptoms, it can be life-threatening and a heart transplant or mechanical circulatory support devices may be required.

What Causes Heart Failure?

Heart Failure results from any condition that weakens the heart and limits its ability to generate adequate cardiac output. Conditions that increase the risk of heart failure include but are not limited to:

Coronary Artery Disease
Past Heart Attack (myocardial infarction)
High Blood Pressure
Abnormal Heart Valves
Heart Muscle Disease (dilated cardiomyopathy, hypertrophic cardiomyopathy)
Heart Muscle Inflammation (myocarditis)
Obesity
Sleep Apnea
Heart Defects Present at Birth (congenital heart disease)
Severe Lung Disease
Diabetes

Heart Failure Therapy

Heart Failure can be segmented into different ACC/AHA stages based on disease development and progression, and NYHA functional classes based on patient symptoms and functional capacity.

Patients with earlier stages of heart failure are often managed with medications (e.g., ACE inhibitors, ARN inhibitors, ARBs, Beta-blockers). However, even with optimal medical management, medications can become less effective as heart failure progresses and advanced treatment options need to be considered.

Initial advanced treatment options may include implantable cardioverter-defibrillator (ICD) and cardiac resynchronization therapy (CRT). If symptoms persist, patients with refractory heart failure and NYHA class IV symptoms may be recommended heart replacement therapy such as mechanical circulatory support (MCS) devices or heart transplants, if eligible.

An overview of the heart failure treatment paradigm based on NYHA classification is illustrated below. There exists a treatment gap between medications and heart replacement therapies. The VIGOR System aims to fill the treatment gap by offering a durable implanted MCS device suitable for NYHA IIIb and ambulatory IV patients. The VIGOR System presents a novel treatment option with the potential of having a safer implantation procedure, less post-operative complications, and higher cost-effectiveness compared to currently available LVAD devices.

ACC: American College of Cardiology; ACE: Angiotensin-converting Enzyme; AHA: American Heart Association; ARB: Angiotensin Receptor Blocker; ARN: Angiotensin Receptor-neprilysin Inhibitor; HT: Heart Transplant; LVAD: Left Ventricular Assist Device; NYHA: New York Heart Association

References

1. American Heart Association. Heart failure. www.heart.org. Retrieved February 2, 2023, from https://www.heart.org/en/health-topics/heart-failure

2. Shah, K. S., Xu, H., Matsouaka, R. A. et al. Heart failure with preserved, borderline, and reduced ejection fraction. Journal of the American College of Cardiology, 70(20), 2476–2486. 2017. https://doi.org/10.1016/j.jacc.2017.08.074

3. Heidenreich, P. A., Bozkurt, B., Aguilar, D., Allen, L. A., Byun, J. J., Colvin, M. M., Deswal, A., Drazner, M. H., Dunlay, S. M., Evers, L. R., Fang, J. C., Fedson, S. E., Fonarow, G. C., Hayek, S. S., Hernandez, A. F., Khazanie, P., Kittleson, M. M., Lee, C. S., Link, M. S., Yancy, C. W. (2022). 2022 AHA/ACC/HFSA guideline for the management of heart failure: A report of the American College of Cardiology/American Heart Association Joint Committee on Clinical Practice Guidelines. Circulation, 145(18). https://doi.org/10.1161/cir.0000000000001063

4. Elliott, A. M., & Lampert, B. C. (2016). Patient selection for long-term mechanical circulatory support: Is it ever too early for the NYHA class III patient? Current Heart Failure Reports, 13(1), 13–19. https://doi.org/10.1007/s11897-016-0279-7