Patients’ Willingness to Accept Mitral Valve Procedure-Associated Risks Varies Across Severity of Heart Failure Symptoms
Open accessAbstract
Background: The Food and Drug Administration’s Center for Devices 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.
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Formal patient interviews indicate that patients with heart failure value reductions in symptoms and improvements in physical function at least as much as they value avoidance of death.
“Formal patient interviews indicate that patients with heart failure value reductions in symptoms and improvements in physical function at least as much as they value avoidance of death. 21-23”
From Semaglutide in Patients with Heart Failure with Preserved Ejection Fraction and Obesity (2023) · cites this paper as [21]
The Preferences section (page not available) identifies improved physical functioning as the most important single attribute, and What the Study Adds says participants would tolerate mortality risk for that improvement. The study compares NYHA-class functioning with the risk of death within 30 days of a procedure; it does not separately establish the value of symptom reduction or compare these benefits with avoiding death generally. (LLM, conf=0.84)
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- Hauber AB, González JM, Groothuis-Oudshoorn CG, Prior T, Marshall DA, Cunningham C, IJzerman MJ, Bridges JF. Statistical methods for the analysis Downloaded from http://ahajournals.org by on August 18, 2026 Circ Cardiovasc Interv. 2019;12:e008051. DOI: 10.1161/CIRCINTERVENTIONS.119.008051 December 2019
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- Authors
- Reed, S. D., Fairchild, A. O., Johnson, F. R., Gonzalez, J. M., Mentz, R. J., Krucoff, M. W., & Vemulapalli, S.
- Affiliations
- Duke University (US)
- Department of Population Health Sciences (S.D.R., F.R.J., J.M.G.), Duke University School of Medicine, Durham, NC.
- Venue
- Circulation: Cardiovascular Interventions
- Published
- 2019-12
- Volume
- 12
- Issue
- 12
- Pages
- e008051-e008051
- ISSN
- 1941-7632 (ISSN-L)
- 1941-7640
- OpenAlex
- W2990567989
- Cited by
- 24
- References
- 16
- Citations by year
- 2025: 4 · 2024: 6 · 2023: 5 · 2022: 5 · 2021: 4
- FWCI
- 1.65
- Type
- journal article
- Language
- en
- Update notices
- correction (2020-07-17)
- Open access
- bronze
- doi.org
- Locations
- Circulation Cardiovascular Interventions (publishedVersion)
- PubMed (publishedVersion)
- Funders
- Ohio State University
- Verily Life Sciences
- Topics
- Health Sciences › Medicine › Cardiology and Cardiovascular Medicine › Cardiac Valve Diseases and Treatments
- Social Sciences › Economics, Econometrics and Finance › Economics and Econometrics › Economic and Environmental Valuation
- Social Sciences › Economics, Econometrics and Finance › Economics and Econometrics › Health Systems, Economic Evaluations, Quality of Life
- Keywords
- patient preferences, risk tolerance, transcatheter mitral valve repair, heart failure, functional mitral regurgitation, risk-benefit trade-off, 30-day mortality, bleeding risk, NYHA functional class, physical function, heart failure hospitalization, shared decision-making, medical device evaluation
- MeSH terms
- Decision Making, Shared, Aged, Choice Behavior, Female, Cardiac Catheterization, Heart Failure, Heart Valve Prosthesis, Hemodynamics, Hemorrhage, Humans, Health Knowledge, Attitudes, Practice, Male, Middle Aged, Mitral Valve, Mitral Valve Insufficiency, Patient Acceptance of Health Care, Risk Factors, Severity of Illness Index, Time Factors, Treatment Outcome, Risk Assessment, Heart Valve Prosthesis Implantation, Recovery of Function, Patient Preference, Mitral Valve Annuloplasty
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