Patient-Centric Outcomes Embraced by Global Heart Valve Experts

A multisociety taskforce has created a method for standardizing how patient outcomes are reported for heart valve disease (HVD), regardless of which valve is being treated and how.

The objectives, the taskforce says in a paper published last week in Circulation: Cardiovascular Quality and Outcomes, are twofold: to improve how the field evaluates the quality of valvular disease care and to move from a procedure- and device-oriented mindset to a patient-centric model that spans diagnosis to treatment, prioritizing the patient’s physical and mental well-being and quality of life (QoL).

The model is comprised of 16 outcome measures in five domains (vital status, patient-reported outcomes, progression of disease, cardiac function, and durability and complications of treatment) meant to be tracked worldwide in patients with aortic, mitral, or tricuspid valve disease.

According to the authors, led by Emmanuel Lansac, MD, PhD (Hôpital Pitié-Salpêtrière, Sorbonne Université, Paris, France), the effort stems from 12 medical societies in 12 nations, plus feedback from patient representatives. “This will allow comparison of the burden, management, and outcomes of heart valve disease care across international borders, thereby contributing to improved patient selection, risk-adjustment models, and eventually higher quality of care for patients with HVD worldwide,” they write.

To TCTMD, Lansac and coauthors Kevin M. Veen, MD, PhD, and Johanna J.M. Takkenberg, MD, PhD (both Erasmus Medical Center, Rotterdam, the Netherlands), said it was a challenge to develop a dataset that applies to all patients with valvular heart disease, but also an opportunity.

“After 3 years of hard work, the creation of this multisociety, international standard is a major achievement in the effort to monitor adults with heart valve disease and evaluate treatment guidelines with a unified evaluation tool covering everything from moderate cases to surgical or percutaneous interventions, with a focus on lifelong patient follow-up,” they noted in a joint email.

The outcome measures include all-cause mortality, QoL, mental health, impact on mental health and daily activities, hospitalization for heart failure, native valve dysfunction, cardiac symptoms, cardiac rhythm, LVEF, endocarditis, valve thrombosis, bleeding event, stroke and thromboembolic event, operative complications, reoperation, and postintervention valve deterioration.

PROMs and Accessibility

The task force recommends that patient-reported measures of health-related QoL, mental state, physical fitness, symptoms, and impact of the disease on daily life be assessed with the EQ-5D-5L questionnaire, which they say was chosen because it is widely used and easy to administer. The other recommended tool is the Heart Valve Disease Impact on Daily Life Questionnaire.

Hemal Gada, MD (University of Pittsburgh Medical Center Heart and Vascular Institute, Harrisburg, PA), who wasn’t part of the task force, said the newly created dataset adds to monitoring that is already being done by the Society of Thoracic Surgeons/American College of Cardiology TVT Registry and others. While it could ultimately aid in judging performance of valve therapies and other treatments, he expressed reservations about the amount of additional work the proposed tracking might put on heart valve teams versus the value of the information it yields.

“We do need to incorporate more patient-reported outcome measures in our assessments of how the patient is feeling at baseline versus the hard metrics that we have, [and] also to understand and assess the results of a particular therapeutic intervention,” he said.

However, Gada questioned why the task force opted for the EQ-5D-5L and the Heart Valve Disease Impact on Daily Life Questionnaire as their chosen patient-reported outcome measures (PROMs) over the more well-known Kansas City Cardiomyopathy Questionnaire (KCCQ).

The task force members told TCTMD that one of their key priorities was ensuring that measures could be implemented globally, including in low-resource settings. This meant selecting a PROM model that is freely accessible to all stakeholders, without licensing fees that could limit its use.

“Additionally, patient representatives favored the Heart Valve Disease Impact on Daily Life questionnaire because it goes beyond simply identifying symptoms or feelings—it also assesses the extent to which these issues inhibit daily living. This provides a more comprehensive picture of a patient’s lived experience, aligning with the set’s focus on patient-centered outcomes,” the authors said.

Lansac and colleagues, in their document, suggest initially evaluating clinic-reported outcome measures at 6 months after diagnosis and then tracking them yearly. Patient-reported outcomes should be tracked annually for most patients, but the committee recommends more frequent assessments in patients who undergo surgical or transcatheter valve procedures.

The paper outlines all appropriate definitions and measurement tools for the other domains, including examples of what may constitute durability issues and treatment complications, as well as a variety of posttreatment complications.

The task force members said their effort is designed to complement, not replace, existing outcome frameworks like the Valve Academic Research Consortium criteria. Since their work is endorsed by major societies, they say the next steps are implementation in HVD clinical practice guidelines and societal databases.

For his part, Gada hopes to see more direction from the task force in the future on how best to use the parameters that they have defined and how the patient-centric components fit into individualized care concerns.

“We should really think about prognostic metrics where a patient is telling us something that jibes with how people have done clinically one way or another. That’s important because patients may have different opinions about the way they feel about a given intervention, . . . which may change their quality of life questionnaire score to some degree,” he said. “So [QoL] should be looked at in terms of a bigger picture matrix in that it counts, but how much it counts is kind of debatable and should be relatively dynamic.”