Implantable Cardiac Alert System for Early Recognition of ST-Segment Elevation Myocardial Infarction

C. Michael Gibson, David Holmes, Ghiath Mikdadi, Dale Presser, David Wohns, Megan K. Yee, Andrew Kaplan, Allen Ciuffo, Arthur L. Eberly, Bruce Iteld, Mitchell W. Krucoff

Research output: Contribution to journalArticle

5 Citations (Scopus)

Abstract

Background: Symptoms remain a poor prompt for acute coronary syndromes (ACS). Timely restoration of perfusion in ST-segment elevation myocardial infarction is associated with improved left ventricular function and survival. Objectives: This report details the results of ALERTS (AngelMed for Early Recognition and Treatment of STEMI), a multicenter, randomized trial of an implantable cardiac monitor that alerts patients with rapidly progressive ST-segment deviation. Methods: High-risk ACS subjects (N = 907) were randomized to a control (alarms deactivated) or treatment group for 6 months, after which alarms were activated in all subjects. The primary safety endpoint was absence of system-related complications (>90%). The composite primary efficacy endpoint was cardiac/unexplained death, new Q-wave myocardial infarction, or detection to presentation time >2 h. Results: Safety was met with 96.7% freedom from system-related complications (n = 30). The efficacy endpoint for a confirmed occlusive event within 7 days was not significantly reduced in the treatment compared with control group (16 of 423 [3.8%] vs. 21 of 428 [4.9%], posterior probability = 0.786). Within a 90-day window, alarms significantly decreased detection to arrival time at a medical facility (51 min vs. 30.6 h; Pr [pt < pc] >0.999). In an expanded analysis using data after the randomized period, positive predictive value was higher (25.8% vs. 18.2%) and false positive rate significantly lower in the ALARMS ON group (0.164 vs. 0.678 false positives per patient-year; p < 0.001). Conclusions: The implantable cardiac system detects early ST-segment deviation and alerts patients of a potential occlusive event. Although the trial did not meet its pre-specified primary efficacy endpoint, results suggest that the device may be beneficial among high-risk subjects in potentially identifying asymptomatic events. (AngelMed for Early Recognition and Treatment of STEMI [ALERTS]; NCT00781118)

Original languageEnglish (US)
Pages (from-to)1919-1927
Number of pages9
JournalJournal of the American College of Cardiology
Volume73
Issue number15
DOIs
StatePublished - Apr 23 2019

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Acute Coronary Syndrome
Safety
Therapeutics
Left Ventricular Function
Multicenter Studies
Perfusion
Myocardial Infarction
Equipment and Supplies
Control Groups
Survival
ST Elevation Myocardial Infarction

Keywords

  • acute coronary syndrome
  • implantable monitoring device
  • ST-segment elevation myocardial infarction
  • symptom-to-door time

ASJC Scopus subject areas

  • Cardiology and Cardiovascular Medicine

Cite this

Implantable Cardiac Alert System for Early Recognition of ST-Segment Elevation Myocardial Infarction. / Gibson, C. Michael; Holmes, David; Mikdadi, Ghiath; Presser, Dale; Wohns, David; Yee, Megan K.; Kaplan, Andrew; Ciuffo, Allen; Eberly, Arthur L.; Iteld, Bruce; Krucoff, Mitchell W.

In: Journal of the American College of Cardiology, Vol. 73, No. 15, 23.04.2019, p. 1919-1927.

Research output: Contribution to journalArticle

Gibson, CM, Holmes, D, Mikdadi, G, Presser, D, Wohns, D, Yee, MK, Kaplan, A, Ciuffo, A, Eberly, AL, Iteld, B & Krucoff, MW 2019, 'Implantable Cardiac Alert System for Early Recognition of ST-Segment Elevation Myocardial Infarction', Journal of the American College of Cardiology, vol. 73, no. 15, pp. 1919-1927. https://doi.org/10.1016/j.jacc.2019.01.014
Gibson, C. Michael ; Holmes, David ; Mikdadi, Ghiath ; Presser, Dale ; Wohns, David ; Yee, Megan K. ; Kaplan, Andrew ; Ciuffo, Allen ; Eberly, Arthur L. ; Iteld, Bruce ; Krucoff, Mitchell W. / Implantable Cardiac Alert System for Early Recognition of ST-Segment Elevation Myocardial Infarction. In: Journal of the American College of Cardiology. 2019 ; Vol. 73, No. 15. pp. 1919-1927.
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abstract = "Background: Symptoms remain a poor prompt for acute coronary syndromes (ACS). Timely restoration of perfusion in ST-segment elevation myocardial infarction is associated with improved left ventricular function and survival. Objectives: This report details the results of ALERTS (AngelMed for Early Recognition and Treatment of STEMI), a multicenter, randomized trial of an implantable cardiac monitor that alerts patients with rapidly progressive ST-segment deviation. Methods: High-risk ACS subjects (N = 907) were randomized to a control (alarms deactivated) or treatment group for 6 months, after which alarms were activated in all subjects. The primary safety endpoint was absence of system-related complications (>90{\%}). The composite primary efficacy endpoint was cardiac/unexplained death, new Q-wave myocardial infarction, or detection to presentation time >2 h. Results: Safety was met with 96.7{\%} freedom from system-related complications (n = 30). The efficacy endpoint for a confirmed occlusive event within 7 days was not significantly reduced in the treatment compared with control group (16 of 423 [3.8{\%}] vs. 21 of 428 [4.9{\%}], posterior probability = 0.786). Within a 90-day window, alarms significantly decreased detection to arrival time at a medical facility (51 min vs. 30.6 h; Pr [pt < pc] >0.999). In an expanded analysis using data after the randomized period, positive predictive value was higher (25.8{\%} vs. 18.2{\%}) and false positive rate significantly lower in the ALARMS ON group (0.164 vs. 0.678 false positives per patient-year; p < 0.001). Conclusions: The implantable cardiac system detects early ST-segment deviation and alerts patients of a potential occlusive event. Although the trial did not meet its pre-specified primary efficacy endpoint, results suggest that the device may be beneficial among high-risk subjects in potentially identifying asymptomatic events. (AngelMed for Early Recognition and Treatment of STEMI [ALERTS]; NCT00781118)",
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author = "Gibson, {C. Michael} and David Holmes and Ghiath Mikdadi and Dale Presser and David Wohns and Yee, {Megan K.} and Andrew Kaplan and Allen Ciuffo and Eberly, {Arthur L.} and Bruce Iteld and Krucoff, {Mitchell W.}",
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T1 - Implantable Cardiac Alert System for Early Recognition of ST-Segment Elevation Myocardial Infarction

AU - Gibson, C. Michael

AU - Holmes, David

AU - Mikdadi, Ghiath

AU - Presser, Dale

AU - Wohns, David

AU - Yee, Megan K.

AU - Kaplan, Andrew

AU - Ciuffo, Allen

AU - Eberly, Arthur L.

AU - Iteld, Bruce

AU - Krucoff, Mitchell W.

PY - 2019/4/23

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N2 - Background: Symptoms remain a poor prompt for acute coronary syndromes (ACS). Timely restoration of perfusion in ST-segment elevation myocardial infarction is associated with improved left ventricular function and survival. Objectives: This report details the results of ALERTS (AngelMed for Early Recognition and Treatment of STEMI), a multicenter, randomized trial of an implantable cardiac monitor that alerts patients with rapidly progressive ST-segment deviation. Methods: High-risk ACS subjects (N = 907) were randomized to a control (alarms deactivated) or treatment group for 6 months, after which alarms were activated in all subjects. The primary safety endpoint was absence of system-related complications (>90%). The composite primary efficacy endpoint was cardiac/unexplained death, new Q-wave myocardial infarction, or detection to presentation time >2 h. Results: Safety was met with 96.7% freedom from system-related complications (n = 30). The efficacy endpoint for a confirmed occlusive event within 7 days was not significantly reduced in the treatment compared with control group (16 of 423 [3.8%] vs. 21 of 428 [4.9%], posterior probability = 0.786). Within a 90-day window, alarms significantly decreased detection to arrival time at a medical facility (51 min vs. 30.6 h; Pr [pt < pc] >0.999). In an expanded analysis using data after the randomized period, positive predictive value was higher (25.8% vs. 18.2%) and false positive rate significantly lower in the ALARMS ON group (0.164 vs. 0.678 false positives per patient-year; p < 0.001). Conclusions: The implantable cardiac system detects early ST-segment deviation and alerts patients of a potential occlusive event. Although the trial did not meet its pre-specified primary efficacy endpoint, results suggest that the device may be beneficial among high-risk subjects in potentially identifying asymptomatic events. (AngelMed for Early Recognition and Treatment of STEMI [ALERTS]; NCT00781118)

AB - Background: Symptoms remain a poor prompt for acute coronary syndromes (ACS). Timely restoration of perfusion in ST-segment elevation myocardial infarction is associated with improved left ventricular function and survival. Objectives: This report details the results of ALERTS (AngelMed for Early Recognition and Treatment of STEMI), a multicenter, randomized trial of an implantable cardiac monitor that alerts patients with rapidly progressive ST-segment deviation. Methods: High-risk ACS subjects (N = 907) were randomized to a control (alarms deactivated) or treatment group for 6 months, after which alarms were activated in all subjects. The primary safety endpoint was absence of system-related complications (>90%). The composite primary efficacy endpoint was cardiac/unexplained death, new Q-wave myocardial infarction, or detection to presentation time >2 h. Results: Safety was met with 96.7% freedom from system-related complications (n = 30). The efficacy endpoint for a confirmed occlusive event within 7 days was not significantly reduced in the treatment compared with control group (16 of 423 [3.8%] vs. 21 of 428 [4.9%], posterior probability = 0.786). Within a 90-day window, alarms significantly decreased detection to arrival time at a medical facility (51 min vs. 30.6 h; Pr [pt < pc] >0.999). In an expanded analysis using data after the randomized period, positive predictive value was higher (25.8% vs. 18.2%) and false positive rate significantly lower in the ALARMS ON group (0.164 vs. 0.678 false positives per patient-year; p < 0.001). Conclusions: The implantable cardiac system detects early ST-segment deviation and alerts patients of a potential occlusive event. Although the trial did not meet its pre-specified primary efficacy endpoint, results suggest that the device may be beneficial among high-risk subjects in potentially identifying asymptomatic events. (AngelMed for Early Recognition and Treatment of STEMI [ALERTS]; NCT00781118)

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KW - symptom-to-door time

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