Hypothetical transcatheter mitral valve repair profiles revealed patients would accept up to a 9.7% (95% CI 8.2-13.3) increase in 30-day mortality risk for NYHA class IV to III improvement.
Cross-Sectional (n=419)
Yes
What is the willingness of patients with heart failure to accept 30-day mortality or bleeding risks for improvements in physical functioning or reductions in hospitalizations with transcatheter mitral valve repair?
Patients with more severe heart failure symptoms (NYHA class IV) are willing to accept significantly higher procedural risks for symptomatic improvement compared to those with less severe symptoms.
BACKGROUND: The Food and Drug Administration's Center for Drugs and Radiological Health issued Guidance in 2016 on generating patient preference information to aid evaluation of medical devices. Consistent with this guidance, we aimed to provide quantitative patient preference evidence on benefit-risk tradeoffs relevant to transcatheter mitral valve repair versus medical therapy for patients with heart failure and symptomatic secondary mitral regurgitation. METHODS: A discrete-choice experiment survey 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. Two samples were recruited: an online US panel of individuals reporting a diagnosis of heart failure (n=244) and patients with heart failure treated at Duke University Health System (n=175). Random-effects logit regression was used to model treatment choices as a function of benefit and risk levels. RESULTS: Across both samples, approximately one-quarter (23.5%) consistently 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, improvement in physical functioning equivalent to a change from New York Heart Association class IV to III was ≈6 times more preferred than a change from New York Heart Association class III to II. Estimated discrete-choice experiment utility gains and losses revealed that respondents would accept up to a 9.7 percentage-point (95% CI, 8.2%-13.3%) increase in risk of 30-day mortality with devices that could improve functioning from New York Heart Association class IV to III, or up to 2.0% (95% CI, 1.4%-2.7%) for an improvement from New York Heart Association class III to II. CONCLUSIONS: Severity of heart failure symptoms influences patients' willingness to accept risks associated with mitral valve medical devices. These findings can inform shared decision-making discussions with patients who are being evaluated for transcatheter mitral valve repair.
Reed et al. (Fri,) conducted a cross-sectional in Heart failure and symptomatic secondary mitral regurgitation (n=419). Transcatheter mitral valve repair (hypothetical device profiles) vs. Medical therapy (hypothetical profiles) was evaluated on Tolerance for 30-day mortality or serious bleeding risks to achieve improvements in physical functioning or reductions in heart failure hospitalizations (95% CI 8.2-13.3). Hypothetical transcatheter mitral valve repair profiles revealed patients would accept up to a 9.7% (95% CI 8.2-13.3) increase in 30-day mortality risk for NYHA class IV to III improvement.
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