The AngelMed Guardian System

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

The AngelMed Guardian SystemWe have exciting news! CVAM is on the cutting edge of cardiac device technology. Our Dr. Kaplan was a co-author on a journal article recently published in the prestigious Journal of American College of Cardiology (JACC). The results were from a large scale (pivotal) device clinical research study, called ALERTS, in which he was the Principal Investigator. This ground breaking medical device, called The AngelMed Guardian System, was approved by the FDA. It monitors the heart’s electrical activity and alerts a patient with vibrations if it detects a potential heart attack. Thousands of lives will be saved by this cardiac device! Journal of the American College of Cardiology Volume 74, Issue 16, October 2019 DOI: 10.1016/j.jacc.2019.07.084

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

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

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.

The AngelMed Guardian SystemMethods: 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).

Request an appointment with CVAM Cardiology

If you live in the area of Mesa, AZ and are interested in seeking cardiology care at CVAM, we welcome you to request an appointment with our team. We have a number of cardiologists who can assist you in achieving your healthy heart goals. Our practice is located at 6116 East Arbor Avenue and can be reached by phone at (480) 641-5400.

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