Patient-Centered Approach for Treatment Decisions in Mitral Valve Prolapse

Feinstein Institute For Medical Research, Manhasset NY

Investigators

Abstract

Project Summary/Abstract Transcatheter edge-to-edge repair (TEER) has transformed the management of patients with degenerative mitral regurgitation (MR). The Cardiothoracic Surgical Trials Network (CTSN) developed the Percutaneous or Surgical Repair In Mitral Prolapse And Regurgitation for ≥65 Year-olds (PRIMARY) trial to study the comparative effectiveness of mitral valve repair (MVR) versus TEER. However, decision aids (DAs) are needed to integrate clinical evidence with patients’ values and preferences to allow them to make informed treatment decisions. Currently, no established DAs exist for patients with degenerative MR even though the Centers for Medicare and Medicaid Services and many cardiovascular professional organizations highlight the importance of shared decision-making (SDM). Several obstacles exist toward implementing SDM in clinical practice including the fact that DAs are often developed long after a trial is published, making it challenging to immediately integrate pivotal trial results into clinical workflows. In this proposal, we will conduct a mixed methods study to elicit from patients and providers what outcomes are most important to them so that in the future we can model the heterogeneity in treatment effect using data from PRIMARY to create patient-centered DAs. This proposal will also study the barriers and facilitators toward the use of SDM among key stakeholders in local Heart Teams. Specific Aim 1: Identify outcomes most important to patients with severe degenerative MR considering TEER or MVR. We will conduct qualitative focus groups among patients with severe degenerative MR to elicit the range of outcomes patients consider important when selecting treatment options. Using these data and the components of the PRIMARY composite endpoint, we will then create and administer a quantitative allocation task survey to characterize how patients with severe MR prioritize outcomes when making treatment decisions. Specific Aim 2: Identify outcomes most important to healthcare providers (HCPs) in recommending TEER or MVR. We will conduct qualitative focus groups among cardiac surgeons, referring cardiologists, interventional cardiologists, and nurses involved in the care of patients with degenerative MR to characterize outcomes important to HCPs. We will then use these data to create and administer a quantitative point allocation survey to characterize how HCPs prioritize outcomes. Specific Aim 3: Identify barriers and facilitators to implementing SDM in mitral valve Heart Teams. We will evaluate the process of introducing SDM into local Heart Teams by conducting qualitative interviews with HCP stakeholders. These data will be used to map workflows and identify the optimal timing and process as well as barriers and facilitators to integrating SDM in clinical practice.