Mount Sinai Researchers Receive $3.6 Million NIH Grant to Improve Mitral Valve Surgery Decisions
Study combines clinical trial data, Medicare records, and machine learning to extend evidence to broader real-world patient populations
Researchers at the Icahn School of Medicine at Mount Sinai have received a $3.6 million, four-year grant from the National Heart, Lung, and Blood Institute (NHLBI), part of the National Institutes of Health (NIH), to develop an approach to extend evidence from clinical trials to a broader population of patients treated in everyday medical practice.
The project, called EVOLVE-MR (Extending Valve-Surgery Outcomes From Landmark Trials to Varied Everyday Patients With Mitral Regurgitation), will link data from major randomized clinical trials with long-term Medicare records. Researchers will use advanced statistical methods and machine learning to determine whether benefits seen in clinical trials extend to a broader, more diverse population and persist over a longer period.
The study is led by Mayte Suárez-Fariñas, PhD, Co-Director of the Division of Biostatistics and Data Science in the Department of Population Health Science and Policy; and Emilia Bagiella, PhD, Co-Director of the Division of Biostatistics and Data Science and Director of the Center for Biostatistics in the Department of Population Health Science and Policy at the Icahn School of Medicine at Mount Sinai.
The project builds on more than a decade of research conducted through the Cardiothoracic Surgical Trials Network (CTSN), an NHLBI-funded network that has conducted landmark randomized clinical trials to determine the best treatment approaches for patients with heart valve disease. It also aligns with the goals of the CAROL Act, federal legislation designed to accelerate the generation and use of evidence in valvular heart disease.
“Landmark trials tell us what works on average for the patients who enrolled, and those are not always the ones we see in everyday practice. Surgeons and patients need evidence that reaches beyond the trial population, down to the individual in front of them, and over a lifetime,” said Dr. Suárez-Fariñas. “EVOLVE-MR links trial data to Medicare records so we can follow these patients and use causal machine learning to identify who benefits most from each surgical strategy.”
Valvular heart disease affects more than 13 million adults in the United States and approximately one in 10 people over age 75. Mitral regurgitation, one of the most common forms of valve disease, occurs when the mitral valve does not close properly, allowing blood to flow backward through the heart. Severe disease can lead to heart failure, reduced quality of life, and premature death.
A major goal of the study is to move beyond asking whether one surgical approach is better overall and instead determine which treatment is most likely to benefit each patient.
The researchers will use modern causal inference methods and machine learning to identify differences in treatment benefit based on patients’ clinical characteristics, demographic factors, and other available information.
The team will also analyze echocardiographic imaging features to explore whether characteristics visible on heart imaging can help predict which surgical strategy may provide the greatest benefit for an individual patient.
“This project combines the power and rigor of clinical trials with the richness of real-world data, allowing the trial results to be generalized to broader patient populations and longer time horizons,” said Dr. Bagiella.
“Over more than a decade, CTSN has been conducting rigorous clinical trials investigating optimal treatment approaches for patients with mitral valve disease. Our Network is thrilled about using novel data science approaches that could extend the insights derived from highly controlled clinical trials to a broader group of patients undergoing these procedures,” said Annetine C. Gelijns, PhD, Edmond A. Guggenheim Professor of Health Policy, Icahn School of Medicine at Mount Sinai. She and Alan J. Moskowitz, MD, are Co-Directors of the Institute for Transformative Clinical Trials and Principal Investigators of the CTSN Coordinating Center. “This is precisely the kind of evidence acceleration the CAROL Act was designed to promote.”
The project will create a unified research dataset and supporting tools that can be used by the CTSN and the broader NIH cardiovascular research community. The infrastructure will be designed to support reproducible research and allow investigators to apply the same framework to additional questions in valvular heart disease.
The study reflects a growing effort to strengthen the connection between clinical research and everyday patient care. The researchers hope to provide clinicians with more representative evidence about the benefits and risks of different surgical strategies.
Ultimately, the EVOLVE-MR project aims to help ensure that advances in valve surgery benefit all patients, not only those who most closely resemble participants in clinical trials.
About the Icahn School of Medicine at Mount Sinai
The Icahn School of Medicine at Mount Sinai is internationally renowned for its outstanding research, educational, and clinical care programs. It is the sole academic partner for the seven member hospitals* of the Mount Sinai Health System, one of the largest academic health systems in the United States, providing care to New York City’s large and diverse patient population.
The Icahn School of Medicine at Mount Sinai offers highly competitive MD, PhD, MD-PhD, and master’s degree programs, with enrollment of more than 1,200 students. It has the largest graduate medical education program in the country, with more than 2,700 clinical residents and fellows training throughout the Health System. The Graduate School of Biomedical Sciences offers 12 degree-granting programs, conducts innovative basic and translational research, and trains more than 470 postdoctoral research fellows.
Ranked 11th nationwide in National Institutes of Health (NIH) funding, the Icahn School of Medicine at Mount Sinai is among the 90th percentile of U.S. private medical schools in Sponsored Programs Direct Expenditures per Principal Investigator, according to the Association of American Medical Colleges. More than 6,900 scientists, educators, and clinicians work within and across dozens of academic departments and multidisciplinary institutes with an emphasis on translational research and therapeutics. Through Mount Sinai Innovation Partners (MSIP), the Health System facilitates the real-world application and commercialization of medical breakthroughs made at Mount Sinai.
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* Mount Sinai Health System member hospitals: The Mount Sinai Hospital; Mount Sinai Brooklyn; Mount Sinai Morningside; Mount Sinai Queens; Mount Sinai South Nassau; Mount Sinai West; and New York Eye and Ear Infirmary of Mount Sinai.
About the Mount Sinai Health System
Mount Sinai Health System is one of the nation’s leading integrated academic health systems and one of the largest in the New York metropolitan area. Its comprehensive system includes seven hospitals, more than 400 outpatient practices, over 600 research and clinical laboratories, the Icahn School of Medicine at Mount Sinai, the Graduate School of Biomedical Sciences, and the Mount Sinai Phillips School of Nursing. Together, the Health System comprises approximately 48,000 employees, more than 9,000 physicians, and 8,600 nurses.
As a leading learning health system, Mount Sinai combines clinical expertise with scientific discovery to improve patient care while training the next generation of health care and biomedical leaders. The Health System provides care across every stage of life, from prenatal care through geriatrics, while advancing personalized medicine through artificial intelligence, data science, and biomedical research.
Mount Sinai is consistently recognized among the nation’s leading academic health systems for patient care, research, and education. The Mount Sinai Hospital is ranked No. 1 in New York by Newsweek and No. 5 on the magazine’s World’s Best Hospitals list. The Icahn School of Medicine at Mount Sinai ranks No. 11 among U.S. medical schools and No. 1 among freestanding medical schools for National Institutes of Health funding, reflecting the strength of its scientific enterprise and leadership in biomedical research.