Project Grant R01HL189182

The National Heart, Lung, and Blood Institute awarded Icahn School of Medicine at Mount Sinai $3.605 million on August 10, 2026, under the Cardiovascular Diseases Research program (CFDA 93.837) to generalize and transport surgical treatment effects from landmark clinical trials to real-world valve surgery populations.

The project, EVOLVE-MR, integrates randomized controlled trials from the Cardiothoracic Surgical Trials Network with longitudinal Medicare claims data to address the gap between the methodological rigor of clinical trials and their limited representativeness. Landmark trials typically enroll younger, healthier patients treated at high-volume academic centers with short follow-up periods, limiting generalizability to older, multimorbid, and diverse populations undergoing valve surgery in routine practice. The recipient will harmonize CTSN and Medicare data to create a unified, de-identified analytic dataset mapped to a common data model with accompanying code, metadata, and documentation supporting reproducible causal inference and reuse by the CTSN and NIH cardiovascular research community. Using modern causal inference frameworks, the work will estimate and extend treatment effects of repair versus replacement and other surgical contrasts across populations and time horizons, projecting two-year trial outcomes to five- to ten-year real-world results while accounting for censoring and differential follow-up.

Performance occurs in New York, New York. The award period extends through May 31, 2030.