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 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.

Public Health Relevance

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. 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.

Agency
National Institute of Health (NIH)
Institute
National Institute on Aging (NIA)
Type
Research Project (R01)
Project #
5R01AG047416-02
Application #
9110086
Study Section
Nursing and Related Clinical Sciences Study Section (NRCS)
Program Officer
Zieman, Susan
Project Start
2015-07-15
Project End
2020-03-31
Budget Start
2016-05-01
Budget End
2017-03-31
Support Year
2
Fiscal Year
2016
Total Cost
Indirect Cost
Name
Northwestern University at Chicago
Department
Surgery
Type
Schools of Medicine
DUNS #
005436803
City
Chicago
State
IL
Country
United States
Zip Code
60611