Patients’ Willingness to Accept Mitral Valve Procedure-Associated Risks Varies Across Severity of Heart Failure Symptoms

Author:

Reed Shelby D.12,Fairchild Angelyn O.2,Johnson F. Reed12,Gonzalez Juan Marcos12,Mentz Robert J.23,Krucoff Mitchell W.23,Vemulapalli Sreekanth23

Affiliation:

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 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.

Publisher

Ovid Technologies (Wolters Kluwer Health)

Subject

Cardiology and Cardiovascular Medicine

同舟云学术

1.学者识别学者识别

2.学术分析学术分析

3.人才评估人才评估

"同舟云学术"是以全球学者为主线,采集、加工和组织学术论文而形成的新型学术文献查询和分析系统,可以对全球学者进行文献检索和人才价值评估。用户可以通过关注某些学科领域的顶尖人物而持续追踪该领域的学科进展和研究前沿。经过近期的数据扩容,当前同舟云学术共收录了国内外主流学术期刊6万余种,收集的期刊论文及会议论文总量共计约1.5亿篇,并以每天添加12000余篇中外论文的速度递增。我们也可以为用户提供个性化、定制化的学者数据。欢迎来电咨询!咨询电话:010-8811{复制后删除}0370

www.globalauthorid.com

TOP

Copyright © 2019-2024 北京同舟云网络信息技术有限公司
京公网安备11010802033243号  京ICP备18003416号-3