{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,1,22]],"date-time":"2026-01-22T17:50:10Z","timestamp":1769104210781,"version":"3.49.0"},"reference-count":18,"publisher":"Ovid Technologies (Wolters Kluwer Health)","issue":"12","content-domain":{"domain":["www.ahajournals.org"],"crossmark-restriction":true},"short-container-title":["Circ: Cardiovascular Interventions"],"published-print":{"date-parts":[[2019,12]]},"abstract":"<jats:sec>\n            <jats:title>Background:<\/jats:title>\n            <jats:p>The Food and Drug Administration\u2019s 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.<\/jats:p>\n          <\/jats:sec>\n          <jats:sec>\n            <jats:title>Methods:<\/jats:title>\n            <jats:p>A discrete-choice experiment survey was designed to quantify patients\u2019 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.<\/jats:p>\n          <\/jats:sec>\n          <jats:sec>\n            <jats:title>Results:<\/jats:title>\n            <jats:p>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 \u22486 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%\u201313.3%) 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%\u20132.7%) for an improvement from New York Heart Association class III to II.<\/jats:p>\n          <\/jats:sec>\n          <jats:sec>\n            <jats:title>Conclusions:<\/jats:title>\n            <jats:p>Severity of heart failure symptoms influences patients\u2019 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.<\/jats:p>\n          <\/jats:sec>","DOI":"10.1161\/circinterventions.119.008051","type":"journal-article","created":{"date-parts":[[2019,11,22]],"date-time":"2019-11-22T10:00:24Z","timestamp":1574416824000},"update-policy":"https:\/\/doi.org\/10.1161\/crossmarkpolicy","source":"Crossref","is-referenced-by-count":23,"title":["Patients\u2019 Willingness to Accept Mitral Valve Procedure-Associated Risks Varies Across Severity of Heart Failure Symptoms"],"prefix":"10.1161","volume":"12","author":[{"given":"Shelby D.","family":"Reed","sequence":"first","affiliation":[{"name":"Department of Population Health Sciences (S.D.R., F.R.J., J.M.G.), Duke University School of Medicine, Durham, NC."},{"name":"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."}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Angelyn O.","family":"Fairchild","sequence":"additional","affiliation":[{"name":"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."}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"F. Reed","family":"Johnson","sequence":"additional","affiliation":[{"name":"Department of Population Health Sciences (S.D.R., F.R.J., J.M.G.), Duke University School of Medicine, Durham, NC."},{"name":"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."}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Juan Marcos","family":"Gonzalez","sequence":"additional","affiliation":[{"name":"Department of Population Health Sciences (S.D.R., F.R.J., J.M.G.), Duke University School of Medicine, Durham, NC."},{"name":"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."}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Robert J.","family":"Mentz","sequence":"additional","affiliation":[{"name":"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."},{"name":"Division of Cardiology, Department of Medicine (R.J.M., M.W.K., S.V.), Duke University School of Medicine, Durham, NC."}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Mitchell W.","family":"Krucoff","sequence":"additional","affiliation":[{"name":"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."},{"name":"Division of Cardiology, Department of Medicine (R.J.M., M.W.K., S.V.), Duke University School of Medicine, Durham, NC."}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Sreekanth","family":"Vemulapalli","sequence":"additional","affiliation":[{"name":"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."},{"name":"Division of Cardiology, Department of Medicine (R.J.M., M.W.K., S.V.), Duke University School of Medicine, Durham, NC."}],"role":[{"role":"author","vocabulary":"crossref"}]}],"member":"276","reference":[{"key":"e_1_3_5_2_2","doi-asserted-by":"publisher","DOI":"10.1016\/S0140-6736(06)69208-8"},{"key":"e_1_3_5_3_2","doi-asserted-by":"publisher","DOI":"10.1016\/j.jacc.2004.09.073"},{"key":"e_1_3_5_4_2","doi-asserted-by":"publisher","DOI":"10.1093\/eurheartj\/ehm001"},{"key":"e_1_3_5_5_2","doi-asserted-by":"publisher","DOI":"10.1056\/NEJMoa1806640"},{"key":"e_1_3_5_6_2","doi-asserted-by":"publisher","DOI":"10.1056\/NEJMoa1805374"},{"key":"e_1_3_5_7_2","doi-asserted-by":"publisher","DOI":"10.1016\/j.ijcard.2018.06.041"},{"key":"e_1_3_5_8_2","doi-asserted-by":"publisher","DOI":"10.1056\/NEJMoa1806640"},{"key":"e_1_3_5_9_2","doi-asserted-by":"publisher","DOI":"10.1056\/NEJMe1102013"},{"key":"e_1_3_5_10_2","unstructured":"U.S. Department of Health and Human Services Food and Drug Administration Center for Devices and Radiological Health and Center for Biologics Evaluation and Research. Guidance for Industry Food and Drug Administration Staff and Other Stakeholders. Patient Preference Information\u2013Voluntary Submission Review in Premarket Approval Applications Humanitarian Device Exemption Applications and De Novo Requests and Inclusion in Decision Summaries and Device Labeling. https:\/\/www.fda.gov\/downloads\/MedicalDevices\/DeviceRegulationandGuidance\/GuidanceDocuments\/UCM446680.pdf. Accessed December 11 2018."},{"key":"e_1_3_5_11_2","doi-asserted-by":"publisher","DOI":"10.1016\/j.jval.2010.11.013"},{"key":"e_1_3_5_12_2","volume-title":"A Framework for Incorporating Information on Patient Preferences Regarding Benefit and Risk into Regulatory Assessment of New Medical Technology","author":"Medical Device Innovation Consortium","year":"2015","unstructured":"Medical Device Innovation Consortium. A Framework for Incorporating Information on Patient Preferences Regarding Benefit and Risk into Regulatory Assessment of New Medical Technology. 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