Shelby D Reed1,2, Angelyn O Fairchild2, F Reed Johnson1,2, Juan Marcos Gonzalez1,2, Robert J Mentz2,3, Mitchell W Krucoff2,3, Sreekanth Vemulapalli2,3. 1. Department of Population Health Sciences (S.D.R., F.R.J., J.M.G.), Duke University School of Medicine, Durham, NC. 2. Duke Clinical Research Institute (S.D.R., A.O.F., F.R.J., J.M.G., R.J.M., M.W.K., S.V.), Duke University School of Medicine, Durham, NC. 3. Division of Cardiology, Department of Medicine (R.J.M., M.W.K., S.V.), Duke University School of Medicine, Durham, NC.
Abstract
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.
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.
Authors: Dalane W Kitzman; David J Whellan; Pamela Duncan; Amy M Pastva; Robert J Mentz; Gordon R Reeves; M Benjamin Nelson; Haiying Chen; Bharathi Upadhya; Shelby D Reed; Mark A Espeland; LeighAnn Hewston; Christopher M O'Connor Journal: N Engl J Med Date: 2021-05-16 Impact factor: 176.079
Authors: Shelby D Reed; Jui-Chen Yang; Timothy Rickert; F Reed Johnson; Juan Marcos Gonzalez; Robert J Mentz; Mitchell W Krucoff; Sreekanth Vemulapalli; Philip B Adamson; David J Gebben; Liliana Rincon-Gonzalez; Anindita Saha; Daniel Schaber; Kenneth M Stein; Michelle E Tarver; Dean Bruhn-Ding Journal: Circ Heart Fail Date: 2021-12-23 Impact factor: 8.790
Authors: Nananda F Col; Diana Otero; Brian R Lindman; Aaron Horne; Melissa M Levack; Long Ngo; Kimberly Goodloe; Susan Strong; Elvin Kaplan; Melissa Beaudry; Megan Coylewright Journal: PLoS One Date: 2022-08-11 Impact factor: 3.752