Medical Devices: Evidence and Research (Jan 2020)

The AngelMed Guardian® System in the Detection of Coronary Artery Occlusion: Current Perspectives

  • Kazmi SHA,
  • Datta S,
  • Chi G,
  • Nafee T,
  • Yee M,
  • Kalia A,
  • Sharfaei S,
  • Shojaei F,
  • Mirwais S,
  • Gibson CM

Journal volume & issue
Vol. Volume 13
pp. 1 – 12

Abstract

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Syed Hassan Abbas Kazmi, Sudarshana Datta, Gerald Chi, Tarek Nafee, Megan Yee, Akshun Kalia, Sadaf Sharfaei, Fahimehalsadat Shojaei, Sabawoon Mirwais, C Michael Gibson Division of Cardiovascular Medicine, Department of Medicine, Beth Israel Deaconess Medical Center, Harvard Medical School, Boston, MA, USACorrespondence: C Michael GibsonPERFUSE Study Group, Division of Cardiovascular Medicine, Beth Israel Deaconess Medical Center, Harvard Medical School, 930 Commonwealth Ave. #3, Boston, MA 02215, USATel +1-617-975-9950Email [email protected]: Total ischemic time, which specifies the time from the onset of chest pain to initiation of reperfusion during percutaneous coronary intervention, consists of two intervals: symptom to door time and door to balloon time. A door to balloon time of 90 mins or less has become a quality-of-care metric in the management of ST elevation myocardial infarction (STEMI). While national efforts made by the American College of Cardiology (ACC) and American Heart Association (AHA) have curtailed in-hospital door to balloon time over the years, a reduction in pre-hospital symptoms to door time presents a challenge in modern interventional Cardiology. Early and complete revascularization has been associated with improved clinical outcomes in MI and strategies that may help reduce symptom to door time, and thus the total ischemic time, are crucial. Rapidly evolving ST-segment changes commonly develop prior to ischemia-related symptom onset, and are detectable even in patients with clinically unrecognized silent MIs. Therefore, a highly intelligent ischemia detection system that alerts patients of ST segment deviation may allow for rapid identification of acute coronary occlusion. The AngelMed Guardian® System is a cardiac activity monitoring and alerting system designed for rapid identification of intracardiac ST-segment changes among patients at a high risk for recurrent ACS events. This article reviews the clinical studies evaluating the design, safety and efficacy of the AngelMed Guardian System and discusses the clinical implications of the device.Keywords: acute coronary syndrome, myocardial infarction, ST elevation myocardial infarction, ischemia monitoring, electrocardiography

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