The Problem: Heart Failure:
Heart Failure (HF) is a growing global health care problem with over $40 billion spent annually in the U.S. Patients with advanced HF suffer from shortness of breath, fatigue, weakness, swollen legs and rapid heart rate. In the United States, there are nearly 6.5 million people suffering with HF with 900,000 new HF patients diagnosed yearly. 300,000 HF patients die each year. There are between 1.6 and 2 million patients who no longer derive significant benefit from currently available drugs or devices. Patients, at this stage, are failing to maintain adequate cardiac output and have only two options: Heart Transplant or Ventricular Assist Devices (VAD).
What are VADs:
A ventricular assist device (VAD), also known as a mechanical circulatory support device, is an implantable mechanical pump that helps pump blood from the lower chambers of the heart (the ventricles) to the rest of the body. Although a VAD can be placed in the left, right or both ventricles of the heart, it is most frequently used in the left ventricle. When placed in the left ventricle it is called a left ventricular assist device (LVAD).
In the U.S., over 250,000 patients are in late stage HF and could benefit from a LVAD. A LVAD may be implanted as a bridge to a heart transplant or as a way for the heart to become strong enough to effectively pump blood on its own. Also, an LVAD may be implanted as a long- term treatment for patients who are not good candidates for a heart transplant.
Annually, there are 2000 to 2500 Total Heart Transplants performed in the United States, limited by the availability of donor hearts. Approximately 2500 to 3000 LVADs are implanted in the U.S. annually This is approximately 63% of total procedures worldwide. Because of the severe complications experienced with LVADs, less than 2% of the patients who could benefit from LVAD intervention, receive it. These complications include neurologic events, embolic and hemorrhagic stroke, non-surgical bleeding, and thrombosis. LVADs also have limited battery life and loss of power will cause death. Additionally, the use of LVADs in children is limited do to size.