Initial clinical results using intracardiac electrogram monitoring to detect and alert patients during coronary plaque rupture and ischemia

J Am Coll Cardiol. 2010 Sep 28;56(14):1089-98. doi: 10.1016/j.jacc.2010.04.053.

Abstract

Objectives: We report the first clinical studies of intracardiac ST-segment monitoring in ambulatory humans to alert them to significant ST-segment shifts associated with thrombotic occlusion.

Background: Despite improvements in door-to-balloon times, delays in symptom-to-door times of 2 to 3 h remain. Early alerting of the presence of acute myocardial infarction could prompt patients to seek immediate medical evaluation.

Methods: Intracardiac monitoring was performed in 37 patients at high risk for acute coronary syndromes. The implanted monitor continuously evaluated the patients' ST segments sensed from a conventional pacemaker right ventricle apical lead, and alerted patients to detected ischemic events.

Results: During follow-up (median 1.52 years, range 126 to 974 days), 4 patients had ST-segment changes of ≥3 SDs of their normal daily range, in the absence of an elevated heart rate. This in combination with immediate hospital monitoring led to angiogram and/or intravascular ultrasonography, which confirmed thrombotic coronary occlusion/ruptured plaque. The median alarm-to-door time was 19.5 min (6, 18, 21, and 60 min, respectively). Alerting for demand-related ischemia at elevated heart rates, reflective of flow-limiting coronary obstructions, occurred in 4 patients. There were 2 false-positive ischemia alarms related to arrhythmias, and 1 alarm due to a programming error that did not prompt cardiac catheterization.

Conclusions: Shifts exceeding 3 SD from a patient's daily intracardiac ST-segment range may be a sensitive/specific marker for thrombotic coronary occlusion. Patient alerting was associated with a median alert-to-door time of 19.5 min for patients at high risk of recurrent coronary syndromes who typically present with 2- to 3-h delays.

Publication types

  • Research Support, Non-U.S. Gov't

MeSH terms

  • Acute Coronary Syndrome / prevention & control*
  • Aged
  • Coronary Artery Disease / diagnosis*
  • Coronary Artery Disease / prevention & control
  • Electrocardiography, Ambulatory / methods*
  • Electrophysiologic Techniques, Cardiac / instrumentation*
  • Electrophysiologic Techniques, Cardiac / methods
  • Equipment Design
  • Equipment Safety
  • Female
  • Follow-Up Studies
  • Humans
  • Male
  • Middle Aged
  • Monitoring, Physiologic / methods
  • Myocardial Ischemia / diagnosis*
  • Myocardial Ischemia / prevention & control
  • Recurrence
  • Risk Assessment
  • Rupture, Spontaneous