Transthoracic echocardiography measurements in 2,668 patients with mild or moderate aortic stenosis are being evaluated to identify reliable markers of disease progression to optimize clinical trial design.
Cohort (n=2,668)
No
Quantifying the real-world variability of echocardiographic measures in mild to moderate aortic stenosis will help optimize imaging endpoints for future clinical trials.
Objectives/Goals: Medical therapies to halt progression of aortic stenosis (AS) are now being studied; however, the sensitivity of transthoracic echocardiography (TTE) measures to detect disease progression remain unclear. We will evaluate alternative TTE-derived measures of AS severity as potential markers of disease progression to improve trial efficiency. Methods/Study Population: We will conduct a retrospective cohort study of adults with mild or moderate aortic stenosis who had TTE imaging at Tufts Medical Center from 2012 to 2024. Two cohorts will be examined: 1) a reproducibility cohort of patients with studies less than 2 months apart to assess measurement consistency; and 2) a progression cohort with studies more than 6 months apart to evaluate disease progression over time. Echocardiographic parameters including peak velocity, mean pressure gradient, and aortic valve area will be used. We will use recurrent quantitative measurements to evaluate reproducibility, variability, and signal-to-noise characteristics and to model implications for efficient clinical trial design. Analysis will use RStudio. Results/Anticipated Results: Overall there are 2,668 patients with progressive AS. Median age at first TTE is 76 (68–83) years. 1,120 (42%) are female. The reproducibility cohort includes 991 patients (1,728 paired TTEs, median 10 days (0–16) apart), and the progression cohort includes 323 patients (323 paired TTEs, median 504 days (394–750) apart). Additional demographic and comorbidity data will be obtained. Recurrent measurements will quantify reproducibility, variability, and signal-to-noise characteristics. Anticipated results include 1) identification of the most reliable measures for tracking progression, 2) characterization of measurement variability, and 3) modeling of implications for efficient clinical trial design and evidence-based patient management. Discussion/Significance of Impact: Interest in therapies to halt aortic stenosis progression is growing. Establishing consensus on the most reproducible and practical imaging endpoints is essential. By quantifying real-world variability, we aim to optimize trial design so that effective treatments can be studied and improve outcomes.
Fischman et al. (Wed,) conducted a cohort in Aortic stenosis (n=2,668). Transthoracic echocardiography (TTE) was evaluated on Reproducibility, variability, and signal-to-noise characteristics of TTE-derived measures. Transthoracic echocardiography measurements in 2,668 patients with mild or moderate aortic stenosis are being evaluated to identify reliable markers of disease progression to optimize clinical trial design.