Abstract 14381: A Novel Non-Invasive Screening Device for Aortic Stenosis
Serge C Harb, Joseph Kassab, Patrick H Collier, Richard A Grimm, Jay Ramchand, Samir R Kapadia- Physiology (medical)
- Cardiology and Cardiovascular Medicine
Introduction: Severe AS is a significant health concern in the elderly population, and a large proportion of asymptomatic cases are not receiving appropriate care. Early intervention is associated with a significant reduction in long-term mortality making early diagnosis and intervention crucial.
Hypothesis: Recent progress in non-invasive (NI) hemodynamic measurements and AI has prompted the exploration of NI screening tools for AS. The ClearSight® system (Edwards) is a NI monitoring device using a finger cuff for continuous hemodynamic assessment. This study aims to evaluate its accuracy as a severe AS screening tool.
Methods: 7,000 consecutive patients referred for TTE were enrolled prospectively, between 12/2020 and 04/2022 and underwent concomitant non-invasive hemodynamic monitoring using the ClearSight ® system. Complete data were obtained on 6,858 patients. The development cohort consisted of 5,334 patients, whereby an AI system was trained to interpret the data obtained from the device with the TTE data serving as the gold standard for diagnosis of severe AS. After the development phase, 1,036 patients were included in the validation cohort, whereby the trained AI system used the data obtained from the device to predict the presence of severe AS.
Results: Severe AS was confirmed by TTE in 54 patients. Based on the optimal threshold (ROC curve), the sensitivity for detecting severe AS in patients without other VHD was 87%, with a NPV of 98.1%, and a specificity of 80%. When including all patients, with and without concomitant non-aortic VHD, the sensitivity remained at 87% for the same threshold, with a similarly very high NPV at 98.9%, while the specificity decreased to 70.7%.
Conclusions: The ClearSight ® system, a finger-cuff NI hemodynamic monitoring tool, serves as an excellent screening test for the early detection of severe AS, with high sensitivity and specificity, and a very high NPV in a large cohort of patients consecutively referred to a TTE laboratory.