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USER MANUAL DO-LBL-06035(L)
| MyoVista® Wavelet ECG (
wav
ECG™) 12-Lead Cardiac Testing Device
General Overview
Repolarization Measures Algorithm Statement
The Repolarization Measures Algorithm Statement is optimized to correlate to relaxation
abnormalities associated with LV diastolic dysfunction and provide the results of applying a series of
criteria using clinical study data . This criteria includes
wav
ECG Measures such as the MyoVista Energy
Classification and the MyoVista Ventricular Indices, and also incorporates conventional ECG measures
such as T-Axis and demographic information such as age and sex .
The Repolarization Measures Algorithm Statement has three categories: “Normal”, “Borderline” and
“Abnormal” .
Table 3-1 . Provides the relative-risk measures for the Repolarization Measures Algorithm Statement .
Example: Clinical studies show that patients with and without cardiac relaxation abnormalities can
exist across the entire range of results for the MyoVista Repolarization Algorithm . However, women
whose MyoVista Repolarization Measures Algorithm Statement is “Abnormal” are over 170% more
likely to have relaxation abnormalities associated with LV diastolic dysfunction when compared to
those whose MyoVista Repolarization Measures Algorithm Statement is “Normal” .
The relative-risk calculations have been generated using clinical study data from a validation dataset
that was independent from the development dataset (see Appendix E) .
Table 3-1
MyoVista Repolarization Measures
Algorithm Statement
Sex
Relative-Risk
Borderline Repolarization Measure
(compared to Categorization
of “Normal”)
Men
>4 .0X
Women
2 .0X
Abnormal Repolarization Measure
(compared to Categorization
of “Normal”)
Men
>5 .0X
Women
2 .7X
For example a patient in this category would
have a greater than 170% higher risk than
patients with a categorization of “Normal” .
Ischemic or Structural Risk Assessment Statement (if applicable)
If the Repolarization Measures Algorithm Statement is either “Borderline” or “Abnormal”, then an
Ischemic or Structural Risk assessment statement will also be displayed below the Repolarization
Measures Statement (see Figure 3-5) .
If the Repolarization Measures Algorithm Statement is classified as “Abnormal”, then the statement
“Probable Ischemic or Structural Abnormality” is displayed .
If the Repolarization Measures Algorithm Statement is classified as “Borderline”, then additional
calculations are applied within the software to further stratify risk, and one of two additional statements
will be displayed: “Possible Ischemic or Structural Abnormality” or “Inconclusive Ischemic or Structural
Risk Assessment” . Some of the borderline classifications have low statistical significance and in these
cases the “Inconclusive Ischemic or Structural Risk Assessment” statement is displayed . The statistical
strength of the analysis for these patients was insufficient due to low incidence in the clinical data . This
should occur in less than 5% of all patients tested .
