Identifying and Facilitating Ventricular Recovery on Mechanical Support

It is estimated that approximately 5 million people in the United States have heart failure,
with more than 500,000 new cases diagnosed each year. Heart failure is a disorder that
develops over many years and can be attributed to a number of conditions, including heart
attack, coronary artery disease, diabetes, high blood pressure, or congenital heart defects.
Although there are many treatment options for heart failure, people with end-stage heart
failure may benefit most from a heart transplant. However, the number of donor organs
available remains limited, making alternative treatments for people with end-stage heart
failure imperative. LVAD support, which has traditionally been used as a bridge to
transplant, may also provide an alternative life-saving measure for patients with advanced
end-stage heart failure. The mechanical circulatory support provided by LVAD may allow the
left side of the heart to rest and recover enough so that removal of the device is possible
and a heart transplant is no longer needed, at least temporarily. However, more research in
this area is needed. Using data collected from patients who have undergone LVAD
implantation, this study will attempt to better assess heart recovery and to generate
criteria for identifying patients eligible for the removal of LVAD support.

Participation in this study will last up to 3 years. First, 3 months before LVAD
implantation, participants' medical records, including their medical history, medical
therapy, and cardiac testing, will be obtained. Next, participants will undergo a weaning
echocardiogram (echo) 1 month after LVAD implantation and, if necessary, monthly for 2 more
months.During the weaning echoes, participants will have their LVAD settings adjusted,
condition monitored, and additional data concerning their status collected. Before each
echo, participants will also undergo a blood draw to determine how much blood thinner they
will receive, if necessary.

12cc of blood will be collected up to 30 days prior to the VAD implant to look at gene
expression and proteins expressed in your white blood cells and blood serum.

During the surgery, a small piece of tissue, ranging in the size from 1/4 inch cubed to 1
inch cubed will be removed from the heart tissue. The surgeon removes the heart tissue as
part of the normal surgical process, so that the surgeon can implant the VAD. Approximately
half of the tissue will then be stored for research purposes.

2-6 weeks after surgery a second blood draw of 12cc will be drawn again to look at the gene
expression and proteins expressed in the patient's white blood cells and blood serum.

Participants who are not eligible to be weaned from LVAD support after the three weaning
echoes will continue to be monitored every 6 months for up to 3 years or until the device is
removed. Participants who are eligible to have the LVAD removed will undergo another echo
after they have recovered from the surgery and are no longer taking any intravenous
medications to help the heart. Data from any routine follow-up echoes will also be collected
from these participants every 6 months until study completion at Year 3.

If the patient's heart recovers and the LVAD is removed, we are interested in removing a
second piece of heart tissue that would otherwise be discarded at the time of removal of the
LVAD.

Inclusion Criteria:

- Eligible to receive an LVAD or biventricular assist device (BIVAD) for clinical
indications.

Exclusion Criteria:

- Refuses LVAD support

- Requires right ventricular assist device (RVAD) placement alone

- In atrial fibrillation with a ventricular response of greater than 120 beats per
minute