Table 4.

Decision Making (Clinician and Patient Perspectives) When a Procedure is Contemplated—Patient‐Centered Research Questions in VHD

Clinician Perspective
Optimal timing of a valve procedure What is the optimal timing of a valve procedure for patients with asymptomatic severe valve disease or symptomatic moderate valve disease? Do cut points for “severe” valve disease need to be re‐evaluated and refined? Do recommendations for valve intervention need to more explicitly integrate the severity of the valvular lesion with the ventricular response to it? Examples include clarifying the optimal timing of valve replacement for patients with severe asymptomatic AS, moderate AS with left ventricular dysfunction or symptoms of HF, and severe asymptomatic aortic regurgitation with evidence of left ventricular dilation or subclinical dysfunction. For these patient groups, if all patients do not benefit from earlier intervention, which subgroups (as identified by imaging, biomarkers, or other factors) may benefit from earlier intervention?
Nonresponders to a valve procedure What are the reasons that some patients do not experience an improvement in survival, quality of life, or functional status after a valve procedure? What are the reasons for a lack of reverse ventricular remodeling or improvement in ventricular function in some patients after a valve procedure? How can we predict who will be a nonresponder to a valve procedure and how can that inform our recommendations and SDM with the patient? Areas of particular interest include patients with significant secondary mitral regurgitation or tricuspid regurgitation. Which patients with secondary mitral regurgitation (eg, based on age, left ventricular size or function, severity of mitral regurgitation, biomarkers, and comorbidities) will benefit from a mitral procedure (eg, transcatheter valve repair or replacement or surgery) vs left ventricular assist device /transplant vs guideline‐directed medical therapy alone? Which patients with secondary tricuspid regurgitation (eg, based on right ventricular size/function, associated pulmonary vascular disease, biomarkers, and severity of tricuspid regurgitation) will benefit from a tricuspid procedure? How best can we understand patient goals and preferences and determine whether the selected therapy is likely to meet patient goals?
Futility of a valve procedure caused by comorbidities and frailty Can we accurately predict when, caused by comorbidities and/or frailty, a valve procedure will not substantively improve the health status of patient even if the procedure is successful? Can current or future risk scores be efficiently and effectively utilized in practice to improve patient counseling and SDM? What role might palliative care consultation play in these scenarios in particular?
Clarifying the relationship between valve disease and symptoms and anticipated benefit of a procedure When is valve disease significant enough such that treating it with a valve intervention is likely to benefit the patient? How do we determine whether symptoms are caused by valve disease or other cardiac or noncardiac comorbidities?
Health status assessment Are currently HF‐specific health status measures appropriate for monitoring patients with valve disease and their response to therapy? What role might alternative or adjunctive assessments tailored to patients with valve disease have in evaluating and monitoring the well‐being of patients with valve disease longitudinally, including before and after a procedure?
Approach to valve procedures Based on patient and anatomical factors, when are surgical vs transcatheter vs hybrid approaches preferred? What are the pros and cons, benefits, and risks of valve choices in various clinical settings (eg, mechanical vs bioprosthetic at a younger age and surgical vs transcatheter valve or type of transcatheter valve when a bicuspid valve is present)? What type and severity of coronary disease ought to be fixed before transcatheter valve repair or replacement and what can be deferred? For multivalve disease, when is a concomitant procedure preferred and when is a staged approach preferred?

Patient Perspective
Patient goals and preferences and integration into VHD trials What do patients with VHD understand about their disease process? What early educational interventions are most effective so patients are prepared to participate in SDM? How does this differ among a diverse patient population (ie, age, frailty, comorbidities, race, sex, language, health literacy)? What outcomes are most important to patients with VHD? How do they vary across diverse patients, including geography (ie rural vs urban locations)? How may this inform the operationalization of advanced heart valve centers? Can a patient‐reported outcome measure based on patients’ goals for therapy perform with reliability and validity to evaluate new treatment options within clinical trials? How would such a goal‐attainment patient‐reported outcome measure correlate with other outcomes, including health status measures, rehospitalization, and mortality? How can a goal‐attainment patient‐reported outcome measure be implemented successfully into clinical practice? What are the measures of success?
Selection of outcomes for SDM trials in VHD Which outcomes most accurately reflect the patient experience as defined by patient stakeholder groups (eg, trust, knowledge, and anxiety)? How do patients prioritize outcomes in the treatment of VHD? Which additional outcomes might also be evaluated to assess the value of SDM (eg, choice of therapy and costs)? How is SDM most accurately measured in cardiovascular care settings? How does the quality of decision making change? How is this different from other clinical scenarios when a heart team is involved in decision making?
Strategies to support an SDM process How is SDM most effectively delivered? Where and when in the care process are SDM interventions most effective (eg, at home, before and/or after clinic)? Who is the most effective at delivering SDM interventions? What is the effect of limited diversity among VHD clinicians on measured outcomes of SDM? Can the interventions be divided up among team members effectively? How might technology be leveraged to aid in SDM (ie, telehealth, electronic health record, smart phones)? What is the comparative effectiveness of an electronic health record–embedded vs paper decision aids for patients with VHD? How does the method of delivery of SDM interventions influence clinician SDM skill sets and attitudes and sustained use?
Impact of policy on delivery of care to patients with VHD Following Medicare mandates for SDM, how does care delivery change? Are changes associated with improved outcomes? What are the unintended consequences of policy mandates for decision aid use or documentation of SDM?

AS indicates aortic stenosis; HF, heart failure; SDM, shared decision making; and VHD, valvular heart disease.