SUSTAIN-IT: Sustaining Quality of Life of the Aged: Heart Transplant or Mechanical Support?

The purpose of this study is to compare health-related quality of life (HRQOL) outcomes in
older (60-80 years) advanced heart failure (HF) patients who undergo heart transplantation
(HT) or mechanical circulatory support (MCS) as a permanent implant (i.e., destination
therapy [DT]) and their caregivers, risk factors for poor HRQOL, adverse event and symptom
burden, and quality-adjusted life years (QALYs). Advanced HF patients, 60-80 years of age,
are an appropriate target group for this study because they are receiving HTs and MCS devices
more frequently, and despite a greater risk for poor clinical outcomes, they have acceptable
rates of survival. Using a prospective, longitudinal design, our multi-site comparative
effectiveness research will compare HRQOL outcomes in patients who receive HT or DT MCS and
their caregivers, from baseline to 2 years post-operatively. The primary aim of this proposed
study is to determine whether older advanced HF patients who undergo DT MCS, as compared to
patients who undergo HT, experience non-inferior change in overall HRQOL (primary), and
domains of HRQOL (physical, mental, and social) from baseline through 2 years after surgery.
Secondary Aims are (1.) to determine whether caregivers of older advanced HF patients who
undergo DT MCS, compared to caregivers of older advanced HF patients who undergo HT,
experience non-inferior change in overall HRQOL and domains from baseline through 2 years
after surgery; (2.-3.) to identify risk factors related to poorer overall HRQOL in older DT
MCS patients and their caregivers, as compared to older HT patients and their caregivers, at
2 years after surgery; (4.) to determine whether older advanced HF patients who undergo DT
MCS, as compared to patients who undergo HT, have non-inferior rates of freedom from adverse
events & symptoms at 1 and 2 years after surgery; and (5) to evaluate the distribution of
QALYs in older advanced HF patients who undergo DT MCS, as compared to patients who undergo
HT at 2 years after surgery. Our proposed study will contribute to better patient-centered
care of older advanced HF patients and their caregivers, by informing decision making and
guiding strategies to enhance post-operative HRQOL.

Patient Inclusion Criteria:

1. Advanced HF and listed with the United Network for Organ Sharing (UNOS) for a
"primary" HT or scheduled to receive a "primary" DT LVAD;

2. Ages 60-80 years and able to speak, read, and understand English;

3. Willing to participate and ability to provide informed consent.

Caregiver Inclusion criteria:

1. Primary caregiver, identified by the patient, prior to DT MCS or while a candidate for
HT;

2. Unpaid family member or friend who helps the patient with self-care;

3. Age > 21 years and able to speak, read, and write English;

4. Willing to participate and ability to provide informed consent.

Patient Exclusion criteria

1. Patient has a prior HT or MCS device

2. Patient is listed for multiple organ transplantation (i.e., heart/lung, heart/kidney,
etc.)

Caregiver Exclusion criterion:

1) Patient refusal to participate.