ABSTRACT
PURPOSE: The purpose of our study was to determine the ability of electrocardiographic (ECG) criteria derived from prior angiographic-ECG correlative studies to identify life-threatening coronary artery obstructive lesions. METHODS: We studied 128 consecutive patients referred from the emergency department for emergent coronary angiography for symptoms and ECG changes suggesting an acute coronary event. Using ECG criteria derived from prior studies, we attempted to predict not only the vessel housing the culprit lesion, but whether the lesion was located proximally in that vessel, and then determined the positive and negative predictive values (PPV and NPV) of the criteria used. RESULTS: Our criteria correctly identified 7 of 11 patients with left main disease, with a PPV of 100% and an NPV of 97%; 12 of 19 patients with proximal left anterior descending coronary artery disease, with a PPV of 67% and an NPV of 94%; and 25 of 28 patients with proximal right coronary artery disease, with a PPV of 64% and an NPV of 97%. The combined PPV and NPV for predicting patients with either left main coronary artery, proximal left anterior descending coronary artery, or proximal right coronary artery disease were 72% and 81%. CONCLUSION: Our study indicates that the location of life-threatening coronary artery lesions in patients presenting with signs and symptoms of acute coronary syndromes can be predicted from the initial ECG with a high degree of accuracy. Recognizing the ECG criteria for such lesions has the potential for shortening door-to-reperfusion time and improving patient outcomes.
Subject(s)
Acute Coronary Syndrome/diagnosis , Coronary Occlusion/diagnosis , Diagnosis, Computer-Assisted/methods , Electrocardiography/methods , Female , Humans , Male , Middle Aged , Reproducibility of Results , Sensitivity and SpecificityABSTRACT
New medical technologies generally must receive clearance or approval for marketing by the US Food and Drug Administration and be covered by an insurer, such as the Centers for Medicare and Medicaid Services, before becoming available for widespread clinical use. These 2 approval processes are discrete and usually occur sequentially rather than collaboratively and simultaneously. To explore potential mechanisms for increasing regulatory collaboration between these 2 key health care agencies, the Duke Clinical Research Institute and Health Strategies Consultancy convened an informal meeting of agency, academic, and industry leaders on December 8 and 9, 2002, titled "Registration/Approval and Coverage/Payment: Exploring Options for Improving Healthcare." This article arises from the discussion at this conference; it does not represent the official views of any person or institution involved. Although the group did not attempt to reach a consensus, it examined several important issues surrounding this regulatory debate. Herein are proposed options for enhancing regulatory efficiency through greater coordination between the FDA and CMS, and discussion of these proposals from the perspectives of members of both agencies, members of stakeholder organizations, and academic observers.
