DEVICE IMPLEMENTATION, VALIDATION, AND APPLICATION ASSESSMENT OF 2 CONTINUOUS 12-LEAD ECG MONITORS DURING PERCUTANEOUS TRANSLUMINAL CORONARY ANGIOPLASTY - DESCRIPTION OF THE VALIDATION METHOD AND IMPLICATIONS FOR CLINICAL-TRIALS

Comparability of clinical and research data sets may be undermined if the instruments used to acquire them vary. Even when standard 12-lead electrocardiographic formals are used for monitoring, proprietary sign al processing techniques and sampling intervals may differ among devic es. In order to directly compare the two commercially available standa rd 12-lead devices with monitoring capabilities, bifurcated wires from a single standard lead set were attached to each device in elective a ngioplasty patients. Neither device was used as a standard; rather, a method was designed to analyze the output from each device independent ly, and then, if results differed, data from both monitors were review ed by consensus to determine the source of the differences. Analysis e ndpoints for each study included study quality, baseline ST-segment le vels, the presence of ischemia, number of ischemic episodes, peak lead location, and peak lead amplitude. Sources of differences in these en dpoints visible to consensus review included variations between device s in baseline stability noise/artifact levels, stability of the QRS co mplex onset, and temporal sampling intervals.