Mentoring and Research in Cardiovascular Device Evaluation

PROJECT SUMMARY/ABSTRACT Dr. Robert Yeh is Director of the Smith Center for Outcomes Research at Beth Israel Deaconess Medical Center, where he leads a program devoted to advancing the evaluation of cardiovascular devices through rigorously-conducted patient-oriented research. This grant will continue to support protected time for mentorship of junior investigators while continuing the overarching goal of developing innovative approaches to enhance the efficiency, fidelity and generalizability of cardiovascular device evaluation through the analysis of unique multidimensional linked datasets. There is an urgent need to develop and implement more efficient approaches to evaluate cardiovascular devices in representative patient populations. There is great enthusiasm for exploiting newer study design and analysis strategies that can more closely approximate the results of a desired but yet-to-be-performed randomized trial, while gaining the efficiency and representativeness of using data routinely collected in the course of patient care. Applying state-of-the-science methods to diverse and rich datasets may identify specific populations with different responses to device treatment - a key step in the ability to deliver individualized patient-centered care. We will apply new methods to transport inferences about treatment effects from pivotal randomized trials of high-risk cardiovascular devices (including mechanical circulatory support devices in cardiogenic shock and drug-coated balloons for treatment of coronary artery disease) to new target populations, representative of patients seen in contemporary practice. We will further evaluate the safety and effectiveness of these devices through application of the target trial framework, a set of conceptual and practical tools for designing observational emulations of randomized trials that is well suited to overcome common forms of selection bias (e.g., immortal time bias) in cardiovascular device comparisons. Finally, we will create a reusable prospective registry platform which can be broadly used to evaluate newly approved medical devices efficiently and reliably. This research will inform the safety and effectiveness of several cardiovascular devices that have not been well studied, provide important clinical information to practicing physicians in the community, and create new standards for the future regulatory evaluation of medical devices, while providing a fertile opportunity for mentorship for the next generation of patient-oriented cardiovascular researchers.