Evaluation of Wearable Acoustic Sensors and Machine Learning Algorithms for Automated Measurement of Left Ventricular Ejection Fraction.

Left ventricular ejection fraction (EF) is a predictor of mortality and guides clinical decisions. Although transthoracic echocardiography (TTE) is commonly used for measuring EF, it has limitations, such as subjectivity and requires expert personnel. Advancements in biosensor technology and artificial intelligence are allowing systems capable of determining left ventricular function and providing automated measurement of EF. In this study, we tested new wearable automated real-time biosensors (Cardiac Performance System [CPS]) that compute EF using waveform machine learning on cardiac acoustic signals. The primary aim was to compare the accuracy of CPS EF with TTE EF. Adult patients presenting to cardiology, presurgical, and diagnostic radiology clinical settings in an academic center were enrolled. TTE examination was performed by a sonographer, followed immediately by a 3-minute recording of acoustic signals from CPS biosensors placed on the chest by nonexpert personnel. TTE EF was calculated offline using the Simpson biplane method. A total of 81 patients (aged 19 to 88 years, 27 women, 20% to 80% EF) were included. Deming regression and Bland-Altman analysis were performed to assess the accuracy of CPS EF against TTE EF. Both Deming regression (slope 0.9981; intercept 0.03415%) and Bland-Altman analysis (bias -0.0247%; limits of agreement [-11.65, 11.60]%) demonstrated equivalency between CPS EF and TTE EF. The receiver operating characteristic for measuring sensitivity and specificity of CPS in identifying subjects with abnormal EF showed an area under the curve value of 0.974 for identifying EF <35% and 0.916 for detecting EF <50% CPS EF intraoperator and interoperator assessments demonstrated low variability. In conclusion, this technology measuring cardiac function from noninvasive biosensors and machine learning on acoustic signals provides an accurate EF measurement that is automated, real-time, and acquired rapidly by personnel with minimal training.