A Novel Non-Invasive Device For Screening And Optimized Management To Improve Heart Failure Outcomes In Patients With Diabetes Mellitus

Abstract

<h3>Background</h3> Evidence shows diabetes mellitus (DM) is major independent risk factor for several cardiovascular disorders including heart failure (HF). Large, randomized clinical trials for screening and revascularization of stable macrovascular disease in diabetics, have failed to demonstrate a significant reduction in cardiac events and HF episodes. Studies have demonstrated that early detection of left ventricular dysfunction and prevention of microvascular complications through glycemic control in diabetes patients is a critical mechanism for reducing the incidence and severity of left ventricular dysfunction and HF. There is a need for a non-invasive, affordable, accurate, absolute and actionable method to facilitate optimized management of diabetes patients across the continuity of care. HEMOTAG, is a small portable device that uses micro-sensors to capture cardiac vibrations and electrocardiogram, transduced via thoracic electrodes. It is a viable option to measure cardiac time intervals (CTIs), surrogate markers for measurements of left ventricular dysfunction. <h3>Methods</h3> In 98 diabetes patients, the predictability value of HEMOTAG-derived CTIs- systolic time ratio index (STRi) = aortic valve opening/ (aortic valve opening to aortic valve closing) normalized by heart rate, aortic valve closing (AVC) and mitral valve opening (MVO) were assessed as valid markers for left ventricular dysfunction measured simultaneously at the time of transthoracic echocardiogram; to determine reduced ejection fraction (EF) <50%, <35%; elevated E/e'>14; and elevated left atrial volume index (LAVI) > 34 ml/m². Linear correlation analysis was performed. Sensitivity, specificity, positive, and negative predictive values were calculated. <h3>Results</h3> Mean age was 70.3 ± 11.6 years, mean EF was 59.0 ± 12.7%, mean E/e' was 17.9 ± 8.5, mean LAVI was 35.4 ± 16.1 ml/m², 30.2% were women. The following was noted with a paired dichotomous interpretation; for STRi and EF <35%: sensitivity 100%, specificity 88%, AUC 0.94; for STRi and EF <50%: sensitivity 94%, specificity 87%, AUC 0.93; for MVO and E/e' >14: sensitivity 92%, specificity 45%, AUC 0.63; for AVC and LAVI>34 ml/m²: sensitivity 92%, specificity 53%, AUC 0.65. <h3>Conclusions</h3> HEMOTAG detected systolic and diastolic dysfunction with high sensitivity and high specificity. This preliminary study has demonstrated the feasibility of estimating left ventricular dysfunction using a portable, non-invasive device that can facilitate screening and optimized management to improve HF outcomes in patients with DM. Further studies are required to validate HEMOTAG as a point-of-care non-invasive assessment for patients with DM. HEMOTAG® development and the clinical study is supported by NHLBI SBIR grant # R44HL149561.