With medicine’s expanding array of life-prolonging technologies, older and sicker people are
increasingly offered invasive interventions. The use of one such therapy, the left ventricular assist
device (LVAD), is growing rapidly among people dying from end-stage heart failure who are ineligible
for heart transplant. These patients elect to live out the remainder of their lives dependent on a partial
artificial heart – so called “destination therapy” (DT). Of the 6,000,000 Americans with heart failure, up
to 250,000 are potentially eligible for DT LVAD.
DT LVAD is a stark example of the difficult decisions created by new technologies for people with
end-stage illness. For eligible patients who decide not to get a device, 2-year survival is <10%. With
DT LVAD 2-year survival is approximately 70%. But there are risks: stroke (11%), serious infection
(33%), severe bleeding (25%), and reoperation (10%). Additionally, patients must be connected to
electricity at all times. Chronic conditions that make patients transplant ineligible persist. Further,
substantial burden is placed on family caregivers.
In a 2012 American Heart Association Scientific Statement, the co-investigators championed shared
decision making for DT LVADs. Our prior research shows problems with current DT LVAD decision
making, including: 1) hospital variation; 2) overly complicated consent forms; 3) use of biased industry
materials; and 4) fear among patients and caregivers. In response, we have worked with a diverse
group of patient, caregiver, provider, and policy-maker stakeholders to develop a patient/caregiver
decision aid in both pamphlet and video formats.
We now propose a single-center pilot study to gain valuable implementation information prior to
entering in to a multicenter trial.
Specific Aim 1: Examine acceptability and feasibility of a decision aid to improve decision making for
patients and caregivers offered DT LVAD.
a. Measure the acceptability of the decision aids using the decision aid acceptability scale;
b. Measure the feasibility by evaluating the proportion of patients offered DT LVAD who
ultimately were recruited, consented, and delivered the decision aids;
c. Conduct a preliminary assessment of outcomes by assessing decision quality (knowledge and
value concordance), decision conflict, decision regret, decision choice, and decision
Specific Aim 2: Determine the relative value of the decision aids through in-depth interviews from