Safety And Efficacy of The HemotagTm Recording Device To Detect Acutely Decompensated Heart Failure

Introduction An increase in cardiac time intervals (CTIs) has been associated with systolic and diastolic dysfunction in patients with cardiovascular disease. The measurement of the CTIs by the HEMOTAGTM recording device has been suggested to identify patients with acutely decompensated heart failure (ADHF) and likely to provide guidance in tailored therapy. Limited data are currently available regarding the feasibility of using the HEMOTAGTM device in clinical practice. Methods HATS-OFF ( H emotag A ssessmen T for S hort-term O utcomes o F heart F ailure) is a prospective, unblinded, single-center, non-randomized study that enrolled 105 patients hospitalized with ADHF (experimental arm) and other acute medical conditions (control arm) between 08/2019 and 12/2019. This study aimed to assess the safety and efficacy of the HEMOTAGTM recording device in detecting ADHF.ADHF was diagnosed based on clinical evaluation, NT-pro-BNP ≥1800 pg/ml, echocardiographic signs, and the need for urgent intravenous diuretics. An isovolumetric contraction time (IVCT) ≥ 40ms was used as a marker of elevated CTIs. Eight patients were eliminated from data analysis due to unusable electrocardiogram (EKG) data or no available NT-pro-BNP. Results Out of 97 patients enrolled, 44% were female, 13% African American (Race), and 27% Hispanics (Ethnicity). The mean age and mean BMI were 63 ± 17 years and 30.5 ± 9.2 kg/m2, respectively. The mean NT-proBNP for the experimental arm was 8,319 pg/ml, and the mean IVCT was 53 ms. For the control arm, the mean NT-proBNP was 362 pg/ml, while the mean IVCT was 32 ms. See Figure 1. As demonstrated in Table 1, an IVCT ≥40ms has a strong sensitivity and specificity to detect ADHF (NT-proBNP ≥1800pg/ml). Safety Outcomes HEMOTAGTM uses EKG electrodes and heart sound technology to evaluate CTIs. During this study, no significant adverse events occurred. Conclusion This study suggests that an IVCT >40ms in a non-invasive HEMOTAGTM recording device can accurately predict ADHF in patients with NT-proBNP >1800 with no significant adverse events. The applicability of this study to our daily practice is that the HEMOTAGTM will help tailor heart failure therapies and improve clinically relevant outcomes, such as heart failure-related hospitalizations and readmission. This hypothesis will be tested on phase 3 clinical trial (HATS OFF study group). NHLBI grant#R44HL145941 .