Validation testing of the SEER real-time digital holter monitor

Perioperative myocardial ischemia, detected by off-line Holter ST-segment monitoring, has been associated with adverse cardiac outcome. Technical advances in digital signal processing have facilitated development of digital Holter recorders that allow 24- to 48-hour recording, full disclosure storage, and "real-time" quantitative analysis of ST-segment levels. These recorders may be useful for "on-line" clinical detection of perioperative ischemia. However, little data are available, independent of manufacturers' claims, to validate their accuracy. Using a previously validated digital electrocardiogram (ECG) simulator, a commercially available device was evaluated.

Laboratory bench study.

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Custom digital ECG waveform templates were programmed for use with a commercially available ECG simulator (M311 ECG simulator; Fogg Systems, Inc, Aurora, CO). For each template, ST-segment morphology (horizontal elevation or depression, downsloping depression), QRS duration (80 v 120 msec) and the presence or absence of a P wave were manipulated, yielding six unique QRS shapes. For each shape, the degree of ST-segment deviation was altered over a wide range. ST-segment values from the simulator (measured at 60 msec after the J point) ranged from +10 to -18 mm. The SEER digital Holter recorder (Marquette Electronics, Milwaukee, WI) was tested. One hundred twenty-six measurements of ST-segment deviation were input to the SEER at each of two testing sessions. The ST-segment value from the recorder in the "noninteractive" analysis mode was obtained, and the two results averaged for comparison with the expected simulator value. Variability of ST-segment measurement over a continuous 1-hour period of simulator input was also assessed. Sixty-seven percent of measurements were within 95% to 100% of expected, whereas 90% were within 90% to 110%. The regression equation for the complete dataset was SEER output (mm) = -0.47 + 1.015 * simulator input, R2 = 0.99. The mean observed-to-expected value ratio was 100% +/- 6% (+/-SD), range 80% to 114%. The mean deviation in millimeters from expected for all measurements was 0.10 +/- 0.20 mm, median 0.05 mm, range -0.25 to +0.60 mm. For the 72 measurements obtained by 5-minute sampling over 1 hour of continuous simulator input for each of the six QRS shapes, the mean percent difference between observed and expected values was 0.5% +/- 4.5%, median 0.0%, with a mean coefficient of variation of 2.7% (median 1.9%).

Using a digital ECG simulator, it was found that the SEER recorder analyzed ST-segment deviation with a high degree of accuracy. These findings, along with its full disclosure reporting capabilities, suggest it may be useful in perioperative risk stratification. However, accuracy in the clinical setting remains to be validated.