Author + information
- Received March 29, 2019
- Revision received June 16, 2019
- Accepted July 17, 2019
- Published online October 14, 2019.
- David R. Holmes Jr., MDa,∗ (, )@CMichaelGibson,
- Mitchell W. Krucoff, MDb,
- Chris Mullin, MScc,
- Ghiath Mikdadi, MDd,
- Dale Presser, MDe,
- David Wohns, MDf,
- Andrew Kaplan, MDg,
- Allen Ciuffo, MDh,
- Arthur L. Eberly III, MDi,
- Bruce Iteld, MDj,
- David R. Fischell, PhDk,
- Tim Fischell, MDk,
- David Keenan, BSk,
- M. Sasha John, PhDk and
- C. Michael Gibson, MS, MDl
- aDepartment of Cardiovascular Medicine, Mayo Clinic, Rochester, Minnesota
- bDuke University Medical Center and Duke Clinical Research Institute, Durham, North Carolina
- cNorth American Science Associates, Inc., Toledo, Ohio
- dHeart Clinic of Hammond, Hammond, Louisiana
- eInnovative Medical Research LLC, Covington, Louisiana
- fDivision of Cardiovascular Medicine, Grand Rapids, Michigan
- gBanner Heart Hospital, Mesa, Arizona
- hSentara Healthcare Norfolk, Norfolk, Virginia
- iGreenville Memorial Hospital, Greenville, South Carolina
- jLouisiana Heart Center, Hammond, Louisiana
- kAngel Medical Systems, Eatontown, New Jersey
- lDivision of Cardiovascular Medicine, Department of Medicine, Beth Israel Deaconess Medical Center, Harvard Medical School, Boston, Massachusetts
- ↵∗Address for correspondence:
Dr. David R. Holmes, Jr., Department of Cardiovascular Medicine, Mayo Clinic, 200 First Street SW, Rochester, Minnesota 55905.
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)
- implantable cardiac monitor
- ischemia monitoring
- pre-hospital delay
- silent myocardial infarction
- supply-side ischemia
- symptom-to-door time
This study was funded by Angel Medical Systems. Drs. Krucoff and Gibson have received research grant support and consulting fees from Angel Medical Systems. Dr. Mullin’s employer (NAMSA) provides testing and consulting services to Angel Medical. Dr. Kaplan has stock ownership in Angel Medical. Dr. Eberly has served as a speaker for AMGEN. Drs. D.R. Fischell, T.A. Fischell, Keenan, and John are employees of and hold stock in Angel Medical Systems. Dr. T.A. Fischell is a shareholder of Ablative Solutions. All other authors have reported that they have no relationships relevant to the contents of this paper to disclose.
- Received March 29, 2019.
- Revision received June 16, 2019.
- Accepted July 17, 2019.
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