Implanted Monitor Alerting to Reduce Treatment Delay in Patients With Acute Coronary Syndrome Events
David R Holmes Jr, Mitchell W Krucoff, Chris Mullin, Ghiath Mikdadi, Dale Presser, David Wohns, Andrew Kaplan, Allen Ciuffo, Arthur L Eberly 3rd, Bruce Iteld, David R Fischell, Tim Fischell, David Keenan, M Sasha John, C Michael Gibson, David R Holmes Jr, Mitchell W Krucoff, Chris Mullin, Ghiath Mikdadi, Dale Presser, David Wohns, Andrew Kaplan, Allen Ciuffo, Arthur L Eberly 3rd, Bruce Iteld, David R Fischell, Tim Fischell, David Keenan, M Sasha John, C Michael Gibson
Abstract
Background: Increased pre-hospital delay during acute coronary syndrome (ACS) events contributes to worse outcome.
Objectives: The purpose of this study was to assess the effectiveness of an implanted cardiac monitor with real-time alarms for abnormal ST-segment shifts to reduce pre-hospital delay during ACS events.
Methods: In the ALERTS (AngeLmed Early Recognition and Treatment of STEMI) pivotal study, subjects at high risk for recurrent ACS events (n = 907) were randomized to control (Alarms OFF) or treatment groups for 6 months, after which alarms were activated in all subjects (Alarms ON). Emergency department (ED) visits with standard-of-care cardiac test results were independently adjudicated as true- or false-positive ACS events. Alarm-to-door (A2D) and symptom-to-door (S2D) times were calculated for true-positive ACS ED visits triggered by 3 possible prompts: alarm only, alarms + symptoms, or symptoms only.
Results: The Alarms ON group showed reduced delays, with 55% (95% confidence interval [CI]: 46% to 63%) of ED visits for ACS events <2 h compared with 10% (95% CI: 2% to 27%) in the Alarms OFF group (p < 0.0001). Results were similar when restricted to myocardial infarction (MI) events. Median pre-hospital delay for MI was 12.7 h for Alarms OFF and 1.6 h in Alarms ON subjects (p < 0.0089). Median A2D delay was 1.4 h for asymptomatic MI. Median S2D delay for symptoms-only MI (no alarm) in Alarms ON was 4.3 h.
Conclusions: Intracardiac monitoring with real-time alarms for ST-segment shift that exceeds a subject's self-normative ischemia threshold level significantly reduced the proportion of pre-hospital delays >2 h for ACS events, including asymptomatic MI, compared with symptoms-only ED visits in Alarms OFF. (AngeLmed for Early Recognition and Treatment of STEMI [ALERTS]; NCT00781118).
Keywords: implantable cardiac monitor; ischemia monitoring; pre-hospital delay; silent myocardial infarction; supply-side ischemia; symptom-to-door time.
Copyright © 2019. Published by Elsevier Inc.
Source: PubMed