Implanted Monitor Alerting to Reduce Treatment Delay in Patients With Acute Coronary Syndrome Events

David R. Holmes, Mitchell W. Krucoff, Chris Mullin, Ghiath Mikdadi, Dale Presser, David Wohns, Andrew Kaplan, Allen Ciuffo, Arthur L. Eberly, Bruce Iteld, David R. Fischell, Tim Fischell, David Keenan, M. Sasha John, C. Michael Gibson

Research output: Contribution to journalArticle

1 Citation (Scopus)

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)

Original languageEnglish (US)
Pages (from-to)2047-2055
Number of pages9
JournalJournal of the American College of Cardiology
Volume74
Issue number16
DOIs
StatePublished - Oct 22 2019

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Acute Coronary Syndrome
Hospital Emergency Service
Therapeutics
Standard of Care
Confidence Intervals

Keywords

  • implantable cardiac monitor
  • ischemia monitoring
  • pre-hospital delay
  • silent myocardial infarction
  • supply-side ischemia
  • symptom-to-door time

ASJC Scopus subject areas

  • Cardiology and Cardiovascular Medicine

Cite this

Implanted Monitor Alerting to Reduce Treatment Delay in Patients With Acute Coronary Syndrome Events. / Holmes, David R.; Krucoff, Mitchell W.; Mullin, Chris; Mikdadi, Ghiath; Presser, Dale; Wohns, David; Kaplan, Andrew; Ciuffo, Allen; Eberly, Arthur L.; Iteld, Bruce; Fischell, David R.; Fischell, Tim; Keenan, David; John, M. Sasha; Gibson, C. Michael.

In: Journal of the American College of Cardiology, Vol. 74, No. 16, 22.10.2019, p. 2047-2055.

Research output: Contribution to journalArticle

Holmes, DR, Krucoff, MW, Mullin, C, Mikdadi, G, Presser, D, Wohns, D, Kaplan, A, Ciuffo, A, Eberly, AL, Iteld, B, Fischell, DR, Fischell, T, Keenan, D, John, MS & Gibson, CM 2019, 'Implanted Monitor Alerting to Reduce Treatment Delay in Patients With Acute Coronary Syndrome Events', Journal of the American College of Cardiology, vol. 74, no. 16, pp. 2047-2055. https://doi.org/10.1016/j.jacc.2019.07.084
Holmes, David R. ; Krucoff, Mitchell W. ; Mullin, Chris ; Mikdadi, Ghiath ; Presser, Dale ; Wohns, David ; Kaplan, Andrew ; Ciuffo, Allen ; Eberly, Arthur L. ; Iteld, Bruce ; Fischell, David R. ; Fischell, Tim ; Keenan, David ; John, M. Sasha ; Gibson, C. Michael. / Implanted Monitor Alerting to Reduce Treatment Delay in Patients With Acute Coronary Syndrome Events. In: Journal of the American College of Cardiology. 2019 ; Vol. 74, No. 16. pp. 2047-2055.
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AU - Holmes, David R.

AU - Krucoff, Mitchell W.

AU - Mullin, Chris

AU - Mikdadi, Ghiath

AU - Presser, Dale

AU - Wohns, David

AU - Kaplan, Andrew

AU - Ciuffo, Allen

AU - Eberly, Arthur L.

AU - Iteld, Bruce

AU - Fischell, David R.

AU - Fischell, Tim

AU - Keenan, David

AU - John, M. Sasha

AU - Gibson, C. Michael

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Y1 - 2019/10/22

N2 - 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)

AB - 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)

KW - implantable cardiac monitor

KW - ischemia monitoring

KW - pre-hospital delay

KW - silent myocardial infarction

KW - supply-side ischemia

KW - symptom-to-door time

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