Pragmatic Evaluation of a Deep-Learning Algorithm to Automate Ejection Fraction on Hand-Held, Point-of-Care Echocardiography in a Cardiac Surgical Operating Room.

ABSTRACT

OBJECTIVE: To test the correlation of ejection fraction (EF) estimated by a deep-learning-based, automated algorithm (Auto EF) versus an EF estimated by Simpson's method. DESIGN: A prospective observational study. SETTING: A single-center study at the Hospital of the University of Pennsylvania. PARTICIPANTS: Study participants were ≥18 years of age and scheduled to undergo valve, aortic, coronary artery bypass graft, heart, or lung transplant surgery. INTERVENTIONS: This noninterventional study involved acquiring apical 4-chamber transthoracic echocardiographic clips using the Philips hand-held ultrasound device, Lumify. MEASUREMENTS AND MAIN RESULTS: In the primary analysis of 54 clips, compared to Simpson's method for EF estimation, bias was similar for Auto EF (-10.17%) and the experienced reader-estimated EF (-9.82%), but the correlation was lower for Auto EF (r = 0.56) than the experienced reader-estimated EF (r = 0.80). In the secondary analyses, the correlation between EF estimated by Simpson's method and Auto EF increased when applied to 27 acquisitions classified as adequate (r = 0.86), but decreased when applied to 27 acquisitions classified as inadequate (r = 0.46). CONCLUSIONS: Applied to acquisitions of adequate image quality, Auto EF produced a numerical EF estimate equivalent to Simpson's method. However, when applied to acquisitions of inadequate image quality, discrepancies arose between EF estimated by Auto EF and Simpson's method. Visual EF estimates by experienced readers correlated highly with Simpson's method in both variable and inadequate imaging conditions, emphasizing its enduring clinical utility.