The Challenge

Each year over one million Americans will have a coronary attack. Approximately every minute (>400,000/year), someone will die of one.
American Heart Association, Circulation
Heart Disease and Stroke Statistics—2013 Update

What We Know
Identifying AMIs early and treating them promptly significantly improves clinical outcomes. Experimental and clinical studies have shown that most irreversible myocardial damage occurs during the first two hours after coronary occlusion. Milavetz et al.Milavetz demonstrated that successful reperfusion therapy within two hours results in the greatest degree of myocardial salvage.

According to Boersma, et al.,Boersma restoration of flow, regardless of the method used, can abort infarction within the first 30 minutes after coronary occlusion, and the benefit of fibrinolytic therapy compared with placebo is considerably higher in patients treated within 2 hours after symptom onset than in those treated later.

Further, evidence advises that the rapid restoration of blood flow after the onset of symptoms in patients with the most severe type of MI, ST elevation MI (STEMI), is a key determinant of short and long-term outcomes. Therefore, the early arrival at the hospital for a prompt diagnosis and treatment is paramount to improve the outcomes of myocardial infarction.



The Problem - Time-to-Door Delay
Despite over 10 years of public campaigns, the mean time from AMI symptom onset to hospital arrival has remained at over 3 hours, even for those who have suffered a prior heart attack.Gibson The largest contributor to this delay is the time interval between symptom onset and the decision to seek medical treatment, stemming primarily from patient misconceptions about symptom experience, expectations, and attribution.

In many cases, patients expect to experience the classic symptoms such as crushing chest pain. They do not know that heart attacks often produce only mild chest pain, discomfort, or other symptoms such as shortness of breath or diaphoresis. Many patients, particularly diabetics, experience no symptoms at all. If patients sought treatment during the first hour following symptom onset, many lives and significant cost could be saved.

Symptom-to-Door-Delay


 

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The Current State of Cardiac Monitoring
While it is possible to monitor ECGs and detect an acute infarction, currently available systems have limitations in the home environment.

  • Twelve-lead ECG systems are not portable and they require a clinically trained individual to place the leads and interpret results.
  • Holter 
monitors have a limited ability to detect ST deviation due to low compliance and in practice provide only a few days of monitoring.
  • All surface lead systems are subject to noise and other artifacts from patient movement and body orientation.
  • Contemporary implantable cardiac monitors are not designed to detect ischemia and cannot detect changes in ST deviation.

ECG monitoring

The Guardian Approach
Only the AngelMed Guardian system is specifically designed to measure ST segment changes in real time, 24/7, and alert the patient to seek medical attention when it detects the electrogram characteristics set by the
physician. Because the monitoring device is implanted, it provides continuous coverage, is less vulnerable to patient compliance deficiencies, and is not susceptible to the noise and other artifacts sustained by surface devices.

AngelMed Guardian System