Home ECG telemonitoring using the SmartHeart 12-lead device did not significantly reduce the composite of ED visits, readmissions, and cardiovascular testing at 90 days post-AMI (63% vs 59%, p=0.61).
RCT
Does the SmartHeart 12-lead ECG telemedicine device reduce emergency department visits, hospital readmissions, and cardiovascular testing in patients discharged after acute myocardial infarction?
Routine prescription of a 12-lead ECG telemedicine device post-AMI did not reduce overall healthcare utilization at 90 days due to low compliance, though per-protocol use was associated with fewer inappropriate ED presentations.
Absolute Event Rate: 63% vs 59%
p-value: p=0.61
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 (59%) patients in the control group and 53 (63%) patients in the intervention group (p = 0.61). However, in the intervention group, only 30% of patients complied with two follow-up training SmartHeart 12-lead ECG transmissions after discharge, and only 24% used the device thereafter. Among device users, ED presentations were lower in the intervention group than in the control group (8.0% vs. 29%, p = 0.04). In all patients advised to present to the ED upon device use (38%) a clinically relevant cardiovascular diagnosis was made. One patient survived a ventricular fibrillation cardiac arrest as advised to present to ED urgently after device use. Conclusion In this U.S.-based RCT, there were no significant differences in the primary outcome in the intention-to-treat analysis. However, according to per-protocol analysis, proper use of the SmartHeart ECG device with 24/7 telemedicine support reduced inappropriate and increased appropriate ED presentations after hospitalization for AMI.
TABI et al. (2026) conducted an RCT in Acute myocardial infarction (AMI). SmartHeart 12-lead ECG telemedicine device vs. Standard of care without the device was evaluated on Rate of emergency department (ED) visits, hospital readmissions, and any cardiovascular testing from discharge to 90 days of follow-up (p=0.61). Home ECG telemonitoring using the SmartHeart 12-lead device did not significantly reduce the composite of ED visits, readmissions, and cardiovascular testing at 90 days post-AMI (63% vs 59%, p=0.61).