Abstract Aims Heart failure is prevalent; however, there is no cost-effective screening option. Against formal echocardiography, we assessed the diagnostic performance of focused cardiac ultrasound (FoCUS), performed by novice users guided and interpreted by artificial intelligence (AI) for the assessment of left ventricular ejection fraction (LVEF). Methods and results We prospectively enrolled 496 adults referred for diagnostic echocardiography. Novice operators (without clinical or imaging experience) underwent a 4-h imaging workshop, then performed FoCUS using a point-of-care device (Philips Lumify) utilizing real-time AI-image guidance (UltraSight). Images were assessed by AI-image interpretation software (Mayo Clinic), and two expert blinded echocardiologists. Median age was 67, 39% female, and body mass index range 17–56 kg/m2. Forty-one subjects (8.3%) exhibited moderate or greater LV dilatation and 28 (5.6%) had LVEF <40%. The median scan time was 4 min (IQR 3–5). Adequate views were achieved in 95.0% and 97.4% of subjects for AI interpretation and expert analysis, respectively. A two-step diagnostic screening process for low EF in which only abnormal AI reads or uninterpretable scans were reviewed by experts (15.1%) had a sensitivity 96.2%, specificity 95.4%, PPV 54.3%, and NPV 99.8%. A subsequent prospective validation study of 344 subjects demonstrated similar results (sensitivity 100%, specificity 99.4%). Conclusion In this early feasibility investigation, AI-guidance technology embedded on a handheld device, enabled novice users without clinical or imaging experience to acquire sufficient quality images to accurately assess LVEF with minimal training. The technology evaluated in this study may hold promise for AI-guidance and interpretation to facilitate low-cost screening for cardiac dysfunction.
Structural heart disease screening using artificial intelligence–enabled electrocardiogram and novice handheld cardiac ultrasound: a cost analysis
Abstract Aims Early detection of structural heart disease (SHD) improves patient outcomes. However, population-based screening is not recommended due to the lack of accurate and cost-effective tools. We evaluated the costs of artificial intelligence–enabled electrocardiogram (AI-ECG) alone vs. AI-ECG followed by handheld cardiac ultrasound (HCU) for SHD screening. Methods and results We performed a model-based cost analysis using data from 286 adult patients who underwent ECG and same-day HCU performed by a novice operator. Transthoracic echocardiogram (TTE) was the reference standard. We compared two screening strategies: (i) AI-ECG alone and (ii) a stepwise approach (AI-ECG followed by HCU). We assessed costs per diagnosis of aortic stenosis (AS), increased left ventricular wall thickness (ILVWT), and left ventricular systolic dysfunction (LVSD). Sensitivity analyses were conducted for varying disease prevalence. The stepwise approach decreased the cost per diagnosis of AS from $6386 (AI-ECG alone) to $2746 (57.0% savings), ILVWT from $4448 to $2895 (34.9% savings), and LVSD from $1469 to $1296 (11.8% savings). Overall, the cost per diagnosis for all SHDs combined decreased from $1940 to $1570 (19.1% savings). Sensitivity analysis demonstrated that cost savings were inversely proportional to disease prevalence. Nevertheless, stepwise screening remained cost-saving compared with AI-ECG alone until prevalence exceeded ∼55.9% for AS, 28.9% for ILVWT, 20.7% for LVSD, and 40.8% for all SHDs combined. Conclusion A stepwise screening strategy incorporating HCU after a positive AI-ECG reduces the immediate costs of SHD detection by minimizing unnecessary TTEs. This approach may enhance the feasibility of population-based SHD screening, particularly in lower-prevalence settings.
Assessment of diastolic function using AI-enhanced electrocardiogram and prognosis in patients with left bundle branch block
Abstract Background Left ventricular diastolic function (LVDF) and left bundle branch block (LBBB) are both linked with increased risk of LV systolic dysfunction, heart failure, and mortality. Assessing LVDF, which is typically done through echocardiography, becomes challenging in the presence of LBBB due to the intraventricular conduction delay that disrupts the reliability of tissue Doppler imaging. Recently, we validated an artificial intelligence-enabled electrocardiogram (AI-ECG) model to assess LVDF and filling pressures. Methods We performed a retrospective study among patients with ECG-confirmed LBBB who also underwent comprehensive echocardiography within 14 days of the index ECG between September 2001 and June 2022. Using multivariable survival models, we assessed the risk of all-cause mortality across AI-ECG-derived LVDF grades. Results Of 2,554 patients with LBBB (mean age 72.0+12.6, 54.6% women), 252 (9.8%), 656 (25.7%), and 1,436 (56.2%), and 210 (8.2%) had normal LVDF, G1 LVDF, G2 LVDF, and G3 LVDF, respectively. The median LV ejection fraction (LVEF) was 54% and 49.3% of the patients had heart failure. Worse LVDF was associated with older age, lower LVEF, and higher rates of diabetes, hypertension, chronic pulmonary disease, renal failure, cardiovascular disease, and heart failure (p-of-trend<0.001 for all). During a median follow-up of 2.6 years (interquartile range 0.5-4.0 years), 847 (33.2%) patients died. In multivariable survival analysis, adjusted to multiple risk factors including baseline LVEF and heart failure, worse LVDF was independently associated with a higher risk of death [G1 LVDF: adjusted hazard ratio (aHR) 2.15 (95% confidence interval (95%CI) 0.75-1.77), G2 LVDF: aHR 2.25 (95%CI 1.50-3.38) G3 LVDF: aHR 2.96 (95%CI 1.88-4.65); p<0.001 for both)]. These findings were consistent also in a subgroup of patients with baseline LVEF > 50%. Conclusion Among patients with LBBB, worse LVDF, as derived by a dedicated AI-ECG algorithm is independently associated with all-cause mortality beyond baseline LVEF and clinical heart failure.survival across AI-ECG LVDF grades
AI-ECG-determined diastolic dysfunction in patients with STEMI
Abstract Background Left ventricular ejection fraction (LVEF) and diastolic dysfunction (DD) are key prognostic factors in patients with ST-segment elevation myocardial infarction (STEMI). AI-enabled ECG (AI-ECG) has been shown to have excellent agreement with transthoracic echocardiography (TTE) assessment and incremental prognostic value to LVEF. Methods We retrospectively analyzed 1,005 adult acute STEMI patients referred for echocardiography (10/2007–01/2025) who had ECGs within seven days before and after the reference echocardiogram. The ECG closest to the TTE date was designated as the pre-STEMI and post-STEMI ECG, respectively. AI-ECG was used to classify diastolic function grades and grades 2 and 3 were considered as DD. Patients were stratified by LVEF (≤50% vs. >50%) at the time of TTE and the association between AI-ECG-determined DD and 10-year mortality was assessed using Cox regression and Kaplan-Meier curves. Results Among 1,005 patients (mean age 66.4 ± 13.4 years, 29.9% females), AI-ECG-determined DD prior to STEMI was present in 47.9% of patients with LVEF ≤50% and 30.3% of those with preserved LVEF (>50%). DD status remained unchanged post-STEMI in 79.3% of cases, while 10.2% showed worsening diastolic function. Regardless of LVEF, AI-ECG-determined DD prior to STEMI was associated with higher mortality risk (LVEF ≤50%: HR 3.03, 95% CI 2.16–4.24, p < 0.001; LVEF >50%: HR 2.32, 95% CI 1.58–3.41, p < 0.001). Post STEMI AI-ECG-determined DD remained a significant predictor of mortality (LVEF ≤50%: HR 2.54, 95% CI 1.82–3.53, p < 0.001; LVEF >50%: HR 2.43, 95% CI 1.66–3.58, p < 0.001). Echocardiographically determined DD also correlated with higher mortality (LVEF ≤50%: HR 4.91, 95% CI 2.95–8.15, p < 0.001; LVEF >50%: HR 2.72, 95% CI 1.68–4.41, p < 0.001). In patients with LVEF ≤50%, AI-ECG-determined DD remained associated with higher mortality even after adjusting for echocardiographically determined DD (pre-STEMI: HR 1.85, 95% CI 1.23–2.80, p < 0.001; post-STEMI: HR 1.90, 95% CI 1.23–2.91, p < 0.001). Conclusion AI-ECG-determined DD is a significant predictor of mortality in STEMI, independent of LVEF. The presence of normal filling pressure may indicate a better clinical outcome in patients with reduced LVEF patients. These findings underscore the clinical utility of AI-ECG in refining risk stratification beyond conventional LVEF assessment.