Mechanical Support Measures of Adjustment and QOL

It is estimated that 5.1 million U.S. adults have heart failure, with an incidence of 825,000
new cases annually. The prevalence of heart failure is expected to increase by 46% from 2012
to 2030. Mechanical circulatory support (MCS) has been developed as a bridge to heart
transplantation and as permanent support (i.e., destination therapy). MCS devices help the
heart pump blood to the body. Left ventricular assist devices (LVADs), a type of MCS, support
the left heart.

Health-related quality of life (HRQOL) is a very important outcome that advanced heart
failure patients care about when making health care decisions, including when considering
surgical treatment options, such as heart transplantation and mechanical circulatory support.

Currently available HRQOL questionnaires do not assess the unique burdens of MCS, such as
changing power sources and driveline exit site dressings; safety precautions (e.g., no
immersion in water, need for an MCS-trained caregiver); troubleshooting VAD alarms; and
MCS-specific complications, often associated with frequent hospitalizations. Since these
questionnaires do not focus on issues of concern to MCS patients, they lack sensitivity and
precision to measure the potentially wide-ranging impact of MCS on HRQOL.

Guided by the investigators empirically supported MCS A-QOL conceptual model, the
investigators will use state-of-the-science psychometric measurement methods to create "item
banks" (sets of items that comprise carefully calibrated questions which define and quantify
a common theme) from the investigators existing MCS A-QOL item pools (library of relevant
items). Using calibrated item banks, the investigators will develop computer adaptive tests
(CATs) and fixed-length short forms to reduce respondent burden and enhance measurement
precision. The investigators will assess reliability, validity, responsiveness to change, and
clinically important differences of MCS A-QOL measures.

The investigators will then explore ways to enhance patient care by using MCS A-QOL
clinically. The investigators will develop and test a mobile CAT app to be used by patients
and their health care providers. A printed computer-generated summary and interpretation of
these measures will be shared with patients and their health care providers during clinic
visits. They will also participate in semi-structured interviews to assess the user
experience (i.e., understandability, usability, and acceptability) of the mobile app and
printed reports.

Group 1 Inclusion Criteria

1. Advanced heart failure patients accepted for, or scheduled for, primary (first time)
implant of a continuous flow MCS device left (L)VAD

2. The continuous flow MCS device implant strategy can be a bridge to transplant,
destination therapy, or bridge to recovery

3. Age >= 19 years and able to speak and understand English

4. Sufficient cognitive ability to provide self-report data on a computer
touchscreen/standard computer and/or on paper-based forms with minimal assistance.

5. Willing to participate and able to give written informed consent

Group 1 Exclusion Criteria:

1. Scheduled for implant of a bi-VAD, right (R)VAD, or total artificial heart

Group 2 Inclusion Criteria:

1. Patient with a continuous flow MCS device left (L)VAD who is more than 3 months
post-implant at the following intervals: 3, 6, 12, 18, 24, 30, 36, 42, 48 months and
every 6 months thereafter. Note: patients can have had prior MCS devices.

2. The continuous flow MCS device, implant strategy can be a bridge to transplant,
destination therapy, or bridge to recovery

3. Age >= 19 years and able to speak and understand English

4. Sufficient cognitive ability to provide self-report data on a computer
touchscreen/standard computer and/or on paper-based forms with minimal assistance

5. Willing to participate and able to give written informed consent

Group 2 Exclusion Criteria:

1. Has a bi-VAD, right (R)VAD, or total artificial heart

Group 3 Inclusion Criteria:

1. Approximately 3 months post-primary (first time) implant of a continuous flow MCS
device

2. Left ventricular assist device (LVAD), with an implant strategy of bridge to
transplant, destination therapy, or bridge to recovery

3. Age >= 19 years and able to speak and understand English

4. Has a smartphone

5. Willing to participate and able to give written informed consent

Group 3 Exclusion Criteria:

1. Has a bi-VAD, right (R)VAD, or total artificial heart