OBJECTIVES: To quantify benefit-risk tradeoffs relevant to transcatheter mitral-valve repair versus medical therapy for patients with heart failure and symptomatic secondary mitral regurgitation, we conducted a discrete-choice experiment (DCE) survey.

METHODS: The DCE was designed to quantify patients’ tolerance for 30-day mortality or serious bleeding risks to achieve improvements in physical functioning or reductions in heart-failure hospitalizations. In addition to two experimentally designed medical-device options, a fixed opt-out (i.e. no device) option represented an individual with New York Heart Association (NYHA) class IV heart failure symptoms and an expectation of 5 heart-failure hospitalizations in the next 2 years. Participants with heart failure were recruited from the Duke University Health System (n=175) or an online US-based panel (n=244).

RESULTS: Across both samples, 56.3% were male, mean age was 65 years, and 44% had symptoms consistent with NYHA class II, and 26.4% with NYHA class III or IV. Nearly one-quarter (23.5%) always chose device profiles offering the higher level of physical functioning despite mortality and bleeding risks as high as 10%. Among respondents who at least once chose a device profile offering a lower level of functioning, physical functioning improvements equivalent to a change from NYHA class IV to III was approximately six times more important than a change from NYHA class III to II. DCE utility gains and losses implied that participants would accept up to a 9.7 percentage-point (95% CI: 8.2%- 13.3%) increase in risk of 30-day mortality with devices offering improved functioning from NYHA class IV to III, but just 2.0% (95% CI: 1.4% to 2.7%) for an improvement from NYHA class III to II.

CONCLUSIONS: As severity of heart-failure symptoms worsen, patients will accept greater risks to achieve improvements in physical functioning. These findings can inform interpretation of clinical trial findings, clinical decision making and regulatory decisions.