Author + information
- Received December 14, 2018
- Revision received January 8, 2019
- Accepted January 14, 2019
- Published online April 15, 2019.
- C. Michael Gibson, MS, MDa,∗ (, )@CMichaelGibson,
- David Holmes, MDb,
- Ghiath Mikdadi, MDc,
- Dale Presser, MDd,
- David Wohns, MD, MBAe,
- Megan K. Yee, MPHa,
- Andrew Kaplan, MDf,
- Allen Ciuffo, MDg,
- Arthur L. Eberly III, MDh,
- Bruce Iteld, MDi and
- Mitchell W. Krucoff, MDj
- aDivision of Cardiovascular Medicine, Department of Medicine, Beth Israel Deaconess Medical Center, Harvard Medical School, Boston, Massachusetts
- bDepartment of Cardiovascular Medicine, Mayo Clinic, Rochester, Minnesota
- cHeart Clinic of Hammond, Hammond, Louisiana
- dInnovative Medical Research LLC, Covington, Louisiana
- eDivision of Cardiovascular Medicine, Spectrum Health, Frederick Meijer Heart and Vascular Institute, Grand Rapids, Michigan
- fBanner Heart Hospital, Mesa, Arizona
- gSentara Healthcare Norfolk, Norfolk, Virginia
- hDivision of Cardiology, Department of Internal Medicine, Greenville Health System, Greenville, South Carolina
- iLouisiana Heart Center, Hammond, Louisiana
- jDuke University Medical Center and Duke Clinical Research Institute, Durham, North Carolina
- ↵∗Address for correspondence:
Dr. C. Michael Gibson, PERFUSE Study Group, Beth Israel Deaconess Medical Center, Cardiovascular Division, 930 Commonwealth Avenue, Boston, Massachusetts 02215.
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)
- acute coronary syndrome
- implantable monitoring device
- ST-segment elevation myocardial infarction
- symptom-to-door time
This study was funded by Angel Medical Systems, Eatontown, New Jersey. Dr. Kaplan is an investor in AngelMed. Dr. Krucoff has been a consultant for and received research grants from Abbott Vascular, AngelMedical, Boston Scientific, and Medtronic. All authors have received research grant support from Angel Medical Systems.
Listen to this manuscript's audio summary by Editor-in-Chief Dr. Valentin Fuster on JACC.org.
- Received December 14, 2018.
- Revision received January 8, 2019.
- Accepted January 14, 2019.
- 2019 American College of Cardiology Foundation