Lewis, B

Abstract Background Acute myocardial infarction (AMI) patients face a substantial risk of cardiovascular events and rehospitalization. The impact of the SmartHeart 12-lead ECG telemedicine device on healthcare utilization has not been tested in a US randomized trial. Methods Patients with AMI were randomized at discharge to standard of care without (control group) or with the SmartHeart 12-lead ECG device (intervention group). The primary endpoint was the rate of emergency department (ED) visits, hospital readmissions, and any cardiovascular testing from discharge to 90 days of follow-up. Results The primary endpoint was reached in 57/96 patients (59.4%) in the control group and 53/84 patients (63.1%) in the intervention group (p = 0.61). However, in the intervention group, only 24.7% of patients complied with 2 follow-up training SmartHeart 12-lead ECG transmissions after discharge, and only 21.6% used the device thereafter. In patients who did use the device after training, 38.2% were advised by the study team to refer to the ED, each time with a significant clinical presentation: 7 patients had chest pain (3 AMI); 2 atrial flutter/fibrillation; 1 ventricular fibrillation. Among device users, ED presentations were lower in the intervention (2/25, 8.0%) than in the control (28/96, 29.2%) group (p = 0.04, Figure 1). Conclusion In this US-based trial, the utilization of the SmartHeart 12-lead ECG device was low, which compromised the primary outcome analysis. Decreased compliances resulted in more ED visits. Figure 1: Cumulative incidence of ED visits in controls and per protocol device use compliant patients.Cumulative incidence of ED visits in con