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

Circ Cardiovasc Interv. 2019 Dec;12(12):e008051. doi: 10.1161/CIRCINTERVENTIONS.119.008051. Epub 2019 Nov 22.

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.

Keywords: heart failure; hospitalization; mitral valve; mortality; risk.

Publication types

  • Comparative Study
  • Research Support, Non-U.S. Gov't

MeSH terms

  • Aged
  • Cardiac Catheterization* / adverse effects
  • Cardiac Catheterization* / instrumentation
  • Cardiac Catheterization* / mortality
  • Choice Behavior*
  • Decision Making, Shared
  • Female
  • Health Knowledge, Attitudes, Practice
  • Heart Failure / diagnostic imaging
  • Heart Failure / mortality
  • Heart Failure / physiopathology
  • Heart Failure / surgery*
  • Heart Valve Prosthesis
  • Heart Valve Prosthesis Implantation* / adverse effects
  • Heart Valve Prosthesis Implantation* / instrumentation
  • Heart Valve Prosthesis Implantation* / mortality
  • Hemodynamics
  • Hemorrhage / etiology
  • Humans
  • Male
  • Middle Aged
  • Mitral Valve / diagnostic imaging
  • Mitral Valve / physiopathology
  • Mitral Valve / surgery*
  • Mitral Valve Annuloplasty* / adverse effects
  • Mitral Valve Annuloplasty* / instrumentation
  • Mitral Valve Annuloplasty* / mortality
  • Mitral Valve Insufficiency / diagnostic imaging
  • Mitral Valve Insufficiency / mortality
  • Mitral Valve Insufficiency / physiopathology
  • Mitral Valve Insufficiency / surgery*
  • Patient Acceptance of Health Care*
  • Patient Preference*
  • Recovery of Function
  • Risk Assessment
  • Risk Factors
  • Severity of Illness Index
  • Time Factors
  • Treatment Outcome