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.

中文翻译：

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患者愿意接受二尖瓣手术相关风险的程度因心力衰竭症状的严重程度而异。

背景：美国食品药品监督管理局药品和放射卫生中心于2016年发布了有关生成患者偏好信息以帮助评估医疗设备的指南。与本指南一致，我们旨在为心力衰竭和有症状的继发性二尖瓣反流患者经导管二尖瓣修复与药物治疗相关的利益风险权衡提供定量的患者偏爱证据。患者对30天死亡率或严重出血风险的承受能力，以改善身体机能或减少心力衰竭住院率。招募了两个样本：美国在线在线小组报告了心力衰竭的诊断（n = 244），并在杜克大学卫生系统（n = 175）治疗了患有心力衰竭的患者。结果：在两个样本中，尽管有死亡和出血风险，但大约有四分之一（23.5％）的患者一致选择了能提供更高水平身体机能的设备配置文件，使用随机效应logit回归对收益和风险水平的函数进行模型化治疗选择高达10％在至少一次选择了功能水平较低的设备配置文件的受访者中，相当于从纽约心脏协会第四级更改为第三级的身体功能方面的改进比纽约心脏协会第三级的更改要高约6倍。到II。估计的离散选择实验效用的得失显示，被调查者会接受可以改善New York Heart功能的设备的30天死亡风险增加9.7个百分点（95％CI，8.2％–13.3％）。协会IV级至III级，或达到2.0％（95％CI，1.4％–2.7％），以改善纽约心脏协会III级至II级。结论：心力衰竭症状的严重程度会影响患者接受相关风险的意愿。与二尖瓣医疗设备。这些发现可以为正在接受经导管二尖瓣修复评估的患者提供共同的决策讨论。或达到2.0％（95％CI，1.4％–2.7％）以达到纽约心脏协会从III级到II级的改善。结论：严重的心力衰竭症状会影响患者接受二尖瓣医疗器械相关风险的意愿。这些发现可以为正在接受经导管二尖瓣修复评估的患者提供共同的决策讨论。或达到2.0％（95％CI，1.4％–2.7％）以达到纽约心脏协会从III级到II级的改善。结论：严重的心力衰竭症状会影响患者接受二尖瓣医疗器械相关风险的意愿。这些发现可以为正在接受经导管二尖瓣修复评估的患者提供共同的决策讨论。