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J Am Coll Cardiol. 2019 Apr 23;73(15):1919-1927. doi: 10.1016/j.jacc.2019.01.014. Epub 2019 Mar 3.

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

Author information

1
Division of Cardiovascular Medicine, Department of Medicine, Beth Israel Deaconess Medical Center, Harvard Medical School, Boston, Massachusetts. Electronic address: mgibson@bidmc.harvard.org.
2
Department of Cardiovascular Medicine, Mayo Clinic, Rochester, Minnesota.
3
Heart Clinic of Hammond, Hammond, Louisiana.
4
Innovative Medical Research LLC, Covington, Louisiana.
5
Division of Cardiovascular Medicine, Spectrum Health, Frederick Meijer Heart and Vascular Institute, Grand Rapids, Michigan.
6
Division of Cardiovascular Medicine, Department of Medicine, Beth Israel Deaconess Medical Center, Harvard Medical School, Boston, Massachusetts.
7
Banner Heart Hospital, Mesa, Arizona.
8
Sentara Healthcare Norfolk, Norfolk, Virginia.
9
Division of Cardiology, Department of Internal Medicine, Greenville Health System, Greenville, South Carolina.
10
Louisiana Heart Center, Hammond, Louisiana.
11
Duke University Medical Center and Duke Clinical Research Institute, Durham, North Carolina.

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).

KEYWORDS:

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

PMID:
30842028
DOI:
10.1016/j.jacc.2019.01.014

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