Patient Risk-Benefit Preferences for Transcatheter versus Surgical Mitral Valve Repair

Value in Health(2023)

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摘要
BACKGROUND: Transcatheter repair of mitral regurgitation (MR) is less invasive than surgery, but has greater five-year mortality and re-intervention risks, as well as more limited functioning. The study objective was to quantify patient preferences for risk-benefit tradeoffs associated with transcatheter and surgical options for MR. METHODS: A discrete-choice experiment survey was administered to patients with MR recruited through a patient advocacy organization. Attributes (and levels) included: procedure type (transcatheter versus surgical); risk of 30-day mortality (2%, 5%, and 10%); risk of five-year mortality (20%, 30%, and 45%) and physical functioning for five years (corresponding to improvements from New York Heart Association [NYHA] class III to I or class III to II); number of hospitalizations (1, 4, and 8) in the next five years; and risk of additional surgery in the next five years (10%, 20%, and 30% or 40%). A mixed-logit regression model was fit to estimate preference weights. RESULTS: 201 individuals completed the survey: 63% were female; mean age was 74 years. On average, respondents preferred transcatheter repair over surgery. To undergo a less invasive procedure (i.e., transcatheter repair), respondents would accept up to a 13.3% (95% confidence interval [CI]: 8.7% to 18.5%) increase in re-intervention risk above a baseline of 10%, 4.6 (95% CI: 3.1 to 6.2) more hospitalizations above a baseline of one, a 9.3% (95% CI: 5.2% to 14.3%) increase in mortality risk above a baseline of 20%, or more limited physical functioning representing nearly one NYHA class (0.8, 95% CI: 0.5 to 1.3) over five years. CONCLUSIONS: Patients in general preferred a transcatheter procedure over surgery. When holding constant all other factors, a functional improvement from NYHA class III to class I maintained over five years would be needed, on average, for patients to prefer surgery over a transcatheter procedure. ### Competing Interest Statement This study was supported by Abbott Laboratories. The funders had no role in the design, analysis, and preparation of the paper. ET and SG are employees of Abbott Laboratories. SV, RJM and SDR report research funding and external relationships at https://dcri.org/about/dcri-faculty/. ### Funding Statement This study was supported by Abbott Laboratories. The funders had no role in the design, analysis, and preparation of the paper. ET and SG are employees of Abbott Laboratories. ### Author Declarations I confirm all relevant ethical guidelines have been followed, and any necessary IRB and/or ethics committee approvals have been obtained. Not Applicable The details of the IRB/oversight body that provided approval or exemption for the research described are given below: Duke University Health System IRB I confirm that all necessary patient/participant consent has been obtained and the appropriate institutional forms have been archived, and that any patient/participant/sample identifiers included were not known to anyone (e.g., hospital staff, patients or participants themselves) outside the research group so cannot be used to identify individuals. Not Applicable I understand that all clinical trials and any other prospective interventional studies must be registered with an ICMJE-approved registry, such as ClinicalTrials.gov. I confirm that any such study reported in the manuscript has been registered and the trial registration ID is provided (note: if posting a prospective study registered retrospectively, please provide a statement in the trial ID field explaining why the study was not registered in advance). Not Applicable I have followed all appropriate research reporting guidelines, such as any relevant EQUATOR Network research reporting checklist(s) and other pertinent material, if applicable. Not Applicable Data can be made available by contacting the study authors.
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transcatheter,risk-benefit
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