This research project is in progress. PCORI will post its findings here within 90 days after our final review is complete. In the meantime, results have been published in peer-reviewed journals, as listed below.
Disease of the aortic heart valve is both common and progressively disabling, with no effective medical treatment. In November 2011, the United States Food and Drug Administration (FDA) approved a new, less invasive transcatheter alternative to surgical aortic valve replacement (AVR). This new technology has changed the treatment of patients with aortic valve disease. In doing so, it has created a pressing clinical need for shared decision-making tools that will help patients understand the risks and benefits of each treatment alternative within the setting of their individual characteristics.
The overarching goal of this study is to develop a new way to approach the treatment of medical illness, by focusing on the expected treatment outcomes for individual patients using information collected from large groups of patients. The cornerstone of this model is a public website that is designed to engage patients and clinicians in a personalized discussion of treatment alternatives. To achieve this goal for patients with aortic valve disease, we will use existing clinical data from the Society of Thoracic Surgeons and American College of Cardiology national procedural registries that have been linked to Medicare claims for patient followup to:
- evaluate important health outcomes with surgical versus transcatheter AVR among patients who would be eligible for surgical AVR, and
- create and evaluate personalized decision assistance tools for all patients considering AVR.
This work will be accomplished in direct partnership with both patients and caregivers as well as a diverse group of stakeholders who will help ensure its usefulness and dissemination. Specifically, we will achieve the three research aims outlined below.
- Specific Aim 1. Compare recent health outcomes with surgical versus transcatheter AVR among patients who are eligible for surgical AVR in the United States
- Specific Aim 2. Create and assess a personalized decision assistance tool to evaluate expected health outcomes with surgical versus transcatheter AVR for patients who are eligible for surgical AVR
- Specific Aim 3. Develop and assess a personalized risk assessment tool to evaluate expected health outcomes with transcatheter AVR for patients who are not eligible for surgical AVR.
Additionally, we will create and evaluate web- and print-based educational resources for targeted dissemination to patients with aortic stenosis, their caregivers, and their healthcare providers. The proposed research will help match patients with the treatment that most closely aligns with their value systems, and it will empower patients to participate actively in their own healthcare decisions. In this way, this study will improve the care of patients with aortic valve disease and reduce overall healthcare expenditures. In addition, this study will serve as a model to promote personalized medicine across all medical disease states.
A Less-Invasive Way to Replace a Heart Valve: Is Newer Better?
A nonsurgical method to replace the aortic valve turned out as safe as surgery and allowed more patients to go home from the hospital, rather than to a nursing home or rehabilitation facility.
Asking patients about what health outcomes mattered most to them helped guide the focus of this PCORI-funded study comparing two treatment options for replacing the aortic valve, one surgical and one less invasive.
Other Health Services Interventions
Training and Education Interventions
Individuals with Multiple Chronic/co-morbid Conditions