Sustaining quality of life of the aged: Heart transplant or mechanical support?

The purpose of this proposed 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). We will use a theoretical framework which models the influence of disease, treatment, adverse events, and symptoms on HRQOL to guide our proposed study. Advanced HF patients, 60-80 years of age, are an appropriate target group for this proposed study because they are receiving HTs and implant of MCS devices more frequently, and despite a greater risk for poor clinical outcomes, they have acceptable rates of survival. Our proposed study may 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. Our proposed study will also provide critical information to support a paradigm shift, from DT MCS implant only after evaluation for HT, to concurrent consideration of both therapies, given that as 2-year survival after MCS approaches the benchmark 2-year survival after HT, HRQOL assumes a much higher priority. Using a prospective, longitudinal design, our proposed 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