Our Research Work
As exciting advances are made in the world of medicine and new therapies become available to treat cardiovascular diseases, there is an increasing need to validate their safety and maximize their benefit for patients. The Smith Center's mission is to apply the highest standard of scientific evaluation to essential questions in cardiovascular medicine. We combine novel analytical approaches with deep clinical expertise to understand and improve patient outcomes and advance healthcare delivery.
The projects listed below are a sample of our current research.
Validation of Observational Data against Clinical Trials
The timely and efficient evaluation of new medical treatments is critical to improving public health. Vast amounts of data are collected in the course of routine patient care by registries, health systems, and payers. These sources of information could be used to support clinical trial evaluations of novel medical interventions, but require validation. The NIH-funded EXTEND Study is using a combination of trial, claims, and registry data to test several hypotheses central to the future evaluation of cardiovascular therapies.
Post-Marketing Surveillance of Paclitaxel Devices
Recent evidence from randomized controlled trials has raised concerns about the long-term safety of paclitaxel-coated stents and balloons used for peripheral artery revascularization. In response to a call by the FDA for more real-world data on the safety of these devices, we are conducting the Safety Assessment of Femoropopliteal Endovascular treatment with PAclitaxel-coated Devices (SAFE-PAD) Study, designed with input from the FDA to provide a long-term, comprehensive evaluation of the mortality risk associated with paclitaxel-coated devices among Medicare beneficiaries. Preliminary results of our work indicate that these devices may be safe, pending longer term evaluation.
We use real world data to understand the best ways to allocate resources to positively impact patient outcomes. Our work in this area has included evaluating insurance coverage and cost effectiveness of PCSK9 inhibitors, a treatment used to lower cholesterol. We have also studied the use of a polypill for secondary prevention of cardiovascular disease in low- and middle-income countries. More recently, we conducted a cost effectiveness analysis of the heart failure drug tafamidis, the most expensive cardiovascular drug ever launched in the United States.
Rigorous Statistical Methods
A major focus of the research at the Smith Center is to evaluate the effectiveness, benefits and potential harms of different cardiovascular treatments and technologies using state-of-the-art statistical methods. We have pioneered the application of pre-post trends and difference-in-difference analyses, originally used in the economics literature, to the evaluation of health policy outcomes. Findings of these studies have shed new light on the impact of the Hospital Readmissions Reduction Program on readmission rates and on hospitals serving poorer patients, and the impact of state Medicaid expansion on cardiovascular mortality. We have also used instrumental variable analyses to evaluate practice patterns and outcomes associated with medical therapies including bivalirudin use in percutaneous coronary intervention and the use of cardiac resynchronization therapy with and without defibrillator backup.
The implementation of the Affordable Care Act brought about changes to the way hospitals are reimbursed by Medicare and Medicaid. National value-based programs, such as the Hospital Readmissions Reduction Program and the Value-Based Purchasing program, aim to use financial rewards and penalties to incentivize the delivery of higher-value care for certain cardiovascular conditions. However, there is growing concern that these programs have had unintended consequences. Researchers at the Smith Center are using large national datasets to investigate the impact of these policies on hospital performance and patient outcomes.
Recent work at the Smith Center has focused on characterizing healthcare disparities across multiple dimensions, including race and ethnicity, socioeconomic status, and neighborhood disadvantage. The goal of this work is to examine factors at the individual, community, and healthcare system levels that are driving disparities in care and outcomes in order to provide insight into potential solutions. Smith Center researchers have performed nationwide analyses that characterize disparities over the last two decades for older adults experiencing poverty. Other work has examined healthcare utilization and outcomes among adults experiencing homelessness, particularly those affected by cardiovascular disease. More recent studies have explored how the COVID-19 pandemic has impacted low-income and minority communities. Smith Center researchers have also focused on the intersection of health policy and disparities to understand how public health and policy interventions affect health equity.
Medical Device Data and Regulation
A growing number of implantable cardiac devices now contain remote monitoring systems that connect patients to clinicians and manufacturers. In addition, large registries of patients with implanted devices are being organized to more quickly identify emerging safety issues. Such intensive collection of personal data can enable researchers to better monitor cardiac disease processes and therapies, but also comes with concerns about privacy, cybersecurity and appropriate use. Smith Center researchers seek to define and evaluate the ethical challenges related to modern information sharing and digital connectivity, better understand the expectations that patients and clinicians have for these capabilities, and examine how federal agencies regulate devices on the market.
Public Reporting of Outcomes
Several states have implemented policies in recent years that mandate public reporting of patient outcomes for certain procedures, including percutaneous coronary intervention. While such policies aim to promote transparency and care quality, the Smith Center has done research into some of the unintended impacts of these policies such as practitioner risk avoidance, institutional costs, changes in diagnosis coding, and other implications for patient outcomes.
End of Life Care in Patients with Implantable Cardiac Devices
Cardiac implantable electrical devices (CIEDs) are increasingly common interventions for a wide spectrum of cardiovascular diseases. Caring for patients with life-sustaining devices such as CIEDs at the end of life raises legal and ethical challenges. Researchers at the Smith Center seek to shed light on these issues and improve our understanding of patients’ and clinicians’ experiences with these therapies in older adults, particularly surrounding issues such as device deactivation, generator replacement, and advance directives.
Identification of Heterogeneous Treatment Effects
Because patients differ from one another in their responses to treatment, identifying those patients who have the greatest opportunity to benefit as well as those with the least to gain from medical interventions is essential for high quality, cost-effective, patient-centered care. Smith Center investigators have a number of projects devoted to understanding heterogeneous treatment effects across a broad spectrum of cardiovascular conditions. In particular, the team is currently working on the NIH R01-funded EXTEND Study with a consortium of investigators to validate the use of real world claims and registry data in the evaluation of medical therapies in representative populations.
Risk Prediction Modeling and Personalized Medicine
Researchers at the Smith Center are developing and testing new technologies to predict individual patients’ risk of adverse events after cardiac procedures based on data from the electronic health record and other administrative data sources. Smith Center researchers have recently published a series of studies which showed that incorporating non-traditional markers of frailty to traditional risk scores can improve the prediction of outcomes such as mortality after transcatheter valve procedures. This work is being expanded by an NIH-funded K24 mentorship grant focused on using claims-based frailty to support individualized treatment of patients with aortic valve stenosis and coronary artery disease.
Guidelines for cardiovascular care increasingly advocate for shared decision-making between clinicians, patients and family members. Researchers at the Smith Center are studying various aspects of shared decision-making in areas such as cardiac device implantation and peripheral artery disease, evaluating its effectiveness in helping patients and clinicians select therapies that align with the patient’s goals, and identifying obstacles to its implementation in the clinical setting. Smith Center researchers have also championed the use of patient-reported outcome measures for patients with coronary and peripheral artery diseases as an important way to incorporate the patient’s perspective into clinical decision-making and the measurement of outcomes.
Imaging Data and Outcomes
The Smith Center is home to the largest US database of cardiac imaging data linked to claims-based outcomes. In collaboration with the National Echo Database Australia (NEDA), researchers aim to improve our understanding of the clinical course of patients with aortic stenosis and other structural heart diseases.