Overview of Current Treatment Options
When HF reaches its final stages, treatment options are few and are radical. Three alternatives destroy the patient’s own heart, replacing it with either a transplant or a device. The other two alternatives, both cell-based, while promising, are not satisfactorily proven, and cannot be accessed other than in clinical trials. If shown to be efficacious, they will not be an immediate one-time solution, but may require a series of treatments.
Heart Transplantation is expensive and not appropriate for many patients with HF; the number of people suitable for heart transplant far exceeds the number of donor hearts available. This option requires significantly invasive operation and hospitalization; frequently requires rehospitalization, and requires extensive lifelong close monitoring and follow-up care.
Heart transplantation replaces one disease: heart failure, with another disease: immuno-compromised patient, having the following problems:
Infection: The risk of infection is high after a heart transplant, as the immune system is suppressed to prevent heart rejection.
Rejection: The immune system may recognize the transplanted heart as foreign and attack it.
Coronary allograft vasculopathy (CAV): CAV is a condition where the arteries supplying the heart narrow, a form of chronic heart rejection, and can lead to heart attack and death.
Kidney disease.
Total Artificial Heart has many limitations. Since 2001, only 1700 patients approximately have been implanted with the Syncardia Total Artificial Heart. It had an FDA class 2 recall in 2023. The Carmat Aeson Total Artificial Heart was first implanted in a patient in 2013; since then, only 50 total have been used in patients.
Ventricular Assist Devices can be an alternative if a heart transplant is not an option. Current Ventricular assist devices (VAD) that exist now are mechanical devices that completely and permanently take over pumping blood to the body while the heart’s own muscle becomes dormant. VADs can be used as a temporary support for people waiting for heart transplants or as a permanent treatment device for people with HF who are not eligible for heart transplants. Ventricular assist devices are used in 3 ways:
LVAD: This device is implanted in the left ventricle of the heart, and helps to pump oxygen-rich blood from the heart to the rest of the body. It is the most common type of VAD. The LVAD has a tube that pulls blood from the left ventricle into a pump. The pump then sends blood into the aorta (the large blood vessel leaving the left ventricle). The pump is placed at the bottom of the heart inside the chest. Another tube attached to the pump is brought out of the abdominal wall to the outside of the body and attached to the pump's battery and control system.
RVAD: This device is implanted in the right ventricle of the heart and helps pump oxygen-poor blood from the heart to the lungs.
BiVAD: This device is a combination of LVAD and RVAD and is used when both sides of the heart are weak.
Cell Editing or in vivo gene editing is being tested and, if proven efficacious, could be a viable alternative treatment. Cells are extracted from a patient’s body, edited, and returned. This treatment is being tested and it must be shown to work for long periods in a variety of patients before it will be deemed safe and effective. Thus, it, too, may see years of clinicals before becoming available. If proven efficacious, our eVAD will be a perfect companion for cell editing while patients are provided with modified gene extractions. Heart function can be maintained as cells are edited.
Stem Cell Therapy cannot be safely accessed. Two decades ago, mesenchymal autologous stem cells, bone marrow derived or adipose derived, whether cardiopoietic or not, were seen as a promising avenue for HF treatment. Small clinical trials had good short-term outcomes but the trials were halted when venture funding disappeared. The resumption of interest in the U.S. is largely experimental among medical centers of excellence in which testing relies largely on pre-clinical assessments. There are companies that can process cells and clinics abroad that provide the treatments, which are a series of injections over time; however, at this time, there is no guaranteed outcome and there is significant risk. It will be decades before safety and efficacy on humans can be confirmed.
