The SmartHeart 12-lead ECG device did not significantly reduce the composite rate of ED visits, readmissions, and cardiovascular testing compared to standard care (63.1% vs 59.4%, p=0.61).
RCT (n=180)
Randomized
Does a 12-lead ECG telemedicine device reduce ED visits, hospital readmissions, and cardiovascular testing in post-AMI patients?
Home 12-lead ECG telemonitoring did not significantly reduce 90-day healthcare utilization in post-AMI patients, largely due to very low patient compliance with the device.
Absolute Event Rate: 63.1% vs 59.4%
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 57/96 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
TABI et al. (Sat,) conducted a rct in Acute myocardial infarction (AMI) (n=180). 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). The SmartHeart 12-lead ECG device did not significantly reduce the composite rate of ED visits, readmissions, and cardiovascular testing compared to standard care (63.1% vs 59.4%, p=0.61).