Priorities for Patient‐Centered Research in Valvular Heart Disease: A Report From the National Heart, Lung, and Blood Institute Working Group

Abstract

Over the past decade, the field of valvular heart disease ( VHD ) has rapidly transformed, largely as a result of the development and improvement of less invasive transcatheter approaches to valve repair or replacement. This transformation has been supported by numerous well‐designed randomized trials, but they have centered almost entirely on devices and procedures. Outside this scope of focus, however, myriad aspects of therapy and management for patients with VHD have either no guidelines or recommendations based only on expert opinion and observational studies. Further, research in VHD has often failed to engage patients to inform study design and identify research questions of greatest importance and relevance from a patient perspective. Accordingly, the National Heart, Lung, and Blood Institute convened a Working Group on Patient‐Centered Research in Valvular Heart Disease, composed of clinician and research experts and patient advocacy experts to identify gaps and barriers to research in VHD and identify research priorities. While recognizing that important research remains to be done to test the safety and efficacy of devices and procedures to treat VHD , we intentionally focused less attention on these areas of research as they are more commonly pursued and supported by industry. Herein, we present the patient‐centered research gaps, barriers, and priorities in VHD and organized our report according to the “patient journey,” including access to care, screening and diagnosis, preprocedure therapy and management, decision making when a procedure is contemplated (clinician and patient perspectives), and postprocedure therapy and management. It is hoped that this report will foster collaboration among diverse stakeholders and highlight for funding bodies the pressing patient‐centered research gaps, opportunities, and priorities in VHD in order to produce impactful patient‐centered research that will inform and improve patient‐centered policy and care.

“What Is the Right Decision for Me?” Integrating Patient Perspectives Through Shared Decision-Making for Valvular Heart Disease Therapy

“…Stressing the importance of matching research efforts to patients' complex and diverse journeys of care, the consensus recommendations strongly endorsed the pressing need to inform research focused on SDM and PROMs across the continuum of care (Figure 3). 46 This leadership illustrates current opportunities to continue to narrow the gap between the rapid innovation in the management of valvular heart disease and patients' perspectives of the care we provide.…”

Effect of a pragmatic home-based mobile health exercise intervention after transcatheter aortic valve replacement: a randomized pilot trial

“… 3 , 4 Accordingly, beyond replacing the heart valve, there is growing recognition that targeting frailty and impaired physical function is important to optimize patient-centred outcomes. 5 A recent report on cardiac rehabilitation (CR) after valve surgery showed that although CR was associated with reduced rehospitalization and mortality in the first year after the surgery, participation rates were only 43%. 6 While the literature demonstrates similar associations between CR and reduced mortality among patients treated for coronary artery disease, rates of participation are even lower.…”

Creating a better journey of care for patients with heart valve disease

“…The selection of the most appropriate intervention (transcatheter or surgical) depends on the person’s risk profile 3 and their individual preferences. 12 If a person is not deemed ready or eligible for an intervention, they are put on active surveillance. A ‘watch and wait’ approach is taken, 3 with the understanding that regular reviews, including echocardiograms, are needed to make sure patients can be offered heart valve replacement or repair should their condition deteriorate.…”

“…Ongoing collection of patient-reported outcomes data can ensure clinical teams are aware of the psychological and quality-of-life status of their patients over time and can offer tailored support accordingly. 12 …”

“… 15 Research priorities include how best to identify and treat asymptomatic illness 7 ; standardized assessment tools to confirm diagnosis 3 ; and gathering patient perspectives and preferences with respect to their care. 12 All of these data then need to be brought into the formulation of clinical guidelines and optimization of care pathways.…”