Methods for determining risk of ventricular arrhythmia

1. A method for analyzing ECG measurements obtained from a patient to determine a patient risk factor corresponding to a level of risk of the patient experiencing a subsequent cardiac event, the method comprising the steps of:

(a) obtaining orthogonal ECG measurements of a patient with 3D ECG measuring equipment; and

(b) providing the obtained ECG measurements to ECG analysis equipment that receives the ECG measurements, performs an ECG analysis, and provides ECG analysis results in a user readable format;

wherein the ECG analysis includes determining at least one cardiac event risk factor having a value, the at least one cardiac event risk factor being determinable from one or more cardiac vector values selected from: sum magnitude of absolute QRST integral (SAI QRST), R/T peaks volume, spatial QRST angle, T-T′ angles, R-R′ angles, T-axes amplitudes, R-axes amplitudes, QRS loops areas, T loops areas, beat-to-beat variability in sum magnitude of absolute QRST integral (SAI QRST), beat-to-beat variability in R/T peaks volume, beat-to-beat variability in spatial QRST angle, beat-to-beat variability in T-T′ angles, beat-to-beat variability in R-R′ angles, beat-to-beat variability in T-axes amplitudes, beat-to-beat variability in R-axes amplitudes, beat-to-beat variability in QRS loops areas, and beat-to-beat variability in T loops areas,

wherein the ECG measurement equipment includes a surface ECG instrument and the ECG measurements are expressed as three lead orthogonal ECG data or the ECG measurement equipment includes an intracardiac electrogram instrument, and

wherein the cardiac event risk factor is a SAI QRST that is determined by plotting a QRST curve for each lead of the expressed three lead orthogonal ECG data or for the ECG measurements,

and calculated via the total sum of the absolute areas under the QRST curve for each of the three leads or the intracardiac electrogram instrument.

2. The method of claim 1 , wherein the ECG measurements are obtained from a patient at rest during a rest time period that is from 2 minutes to 10 minutes.

3. The method of claim 1 , further comprising determining a ratio of a T peaks cloud volume to a R peaks cloud volume determined by calculating the ratio of the T peaks cloud volume to the R peaks cloud volume of three dimensional orthogonal ECG measurements of a patient for a selected time period or number of beats.

4. The method of claim 3 , wherein the selected time period or number of beats is from 30 beats to 500 beats.

5. The method of claim 4 , wherein variability of the SAI QRST values from beat to beat is indicative of a high risk of a subsequent cardiac event.

6. The method of claim 1 , further comprising a step of:

(c) assigning a cardiac event risk factor of low, intermediate, or high based upon the value of the at least one cardiac event risk factor.

7. The method of claim 6 , wherein the cardiac event risk factor is a SAI QRST, and the cardiac event risk factor is low when the SAI QRST is equal to or greater than 145 mV*ms.

8. The method of claim 6 , wherein the cardiac event risk factor is a SAI QRST, and the cardiac event risk factor is intermediate when the SAI QRST is from 70 mV*ms to 145 mV*ms.

9. The method of claim 6 , wherein the cardiac event risk factor is a SAI QRST, and the cardiac event risk factor is high when the SAI QRST is less than 69 mV*ms.

10. The method of claim 6 , wherein the SAI QRST evaluation is utilized to screen patients with structural heart disease for implantation of an ICD (intracardiac device).

11. The method of claim 1 , wherein the cardiac event risk factor that is determined is the ratio of the T peaks cloud volume to the R peaks cloud volume, wherein a R/T ratio of 0.125 or lesser is indicative of a high risk of a subsequent cardiac event.

12. The method of claim 1 , wherein beat-to-beat variability in one or more of the cardiac vectors is indicative of a high risk of a subsequent cardiac event.

13. The method of claim 12 , wherein the variability is detected as a variance (Var) in the spatial QRST angle of greater than 90 degrees over multiple beats, and such detection confirms or enhances a determination of high risk for a subsequent cardiac event.

14. The method of claim 12 , wherein the variability is detected as a root mean square successive difference (rMSSD) in the measured spatial QRS-T angle>12° between multiple beats, and such detection confirms or enhances a determination of high risk for a subsequent cardiac event.

15. The method of claim 12 , wherein the variability is detected as Var in the measured spatial T-T′ angle>65° between multiple beats, and such detection confirms or enhances a determination of high risk for a subsequent cardiac event.

16. The method of claim 12 , wherein the variability is detected as a rMSSD in the measured spatial T-T′ angle>10°, and such detection confirms or enhances a determination of high risk for a subsequent cardiac event.

17. An ECG analysis system for analyzing ECG measurements obtained from a patient to determine a patient risk factor corresponding to a level of risk of the patient experiencing a subsequent cardiac event, the ECG analysis system comprising:

(a) 3D ECG measuring equipment that obtains orthogonal ECG measurements; and

(b) ECG analysis equipment operatively connected to the ECG measuring equipment that receives the ECG measurements, performs an ECG analysis, and provides ECG analysis results in a user readable format;

wherein the ECG analysis includes determining at least one cardiac event risk factor having a value, the at least one cardiac event risk factor being determinable from one or more cardiac vector values selected from: sum magnitude of absolute QRST integral (SAI QRST), R/T peaks volume, spatial QRST angle, T-T′ angles, R-R′ angles, T-axes amplitudes, R-axes amplitudes, QRS loops areas, T loops areas, beat-to-beat variability in sum magnitude of absolute QRST integral (SAI QRST), beat-to-beat variability in R/T peaks volume, beat-to-beat variability in spatial QRST angle, beat-to-beat variability in T-T′ angles, beat-to-beat variability in R-R′ angles, beat-to-beat variability in T-axes amplitudes, beat-to-beat variability in R-axes amplitudes, beat-to-beat variability in QRS loops areas, and beat-to-beat variability in T loops areas

wherein the ECG measurement equipment includes a surface ECG instrument and the ECG measurements are expressed as three lead orthogonal ECG data or the ECG measurement equipment includes an intracardiac electrogram instrument, and

wherein the cardiac event risk factor is a SAI QRST that is determined by plotting a QRST curve for each lead of the expressed three lead orthogonal ECG data or for the ECG measurements,

and calculated via the total sum of the absolute areas under the QRST curve for each of the three leads or the intracardiac electrogram instrument.

18. The ECG analysis system of claim 17 , wherein the ECG measuring equipment includes the surface ECG instrument.

19. The ECG analysis system of claim 17 , wherein the ECG measuring equipment includes the intracardiac electrogram instrument.

20. The ECG analysis system of claim 17 , wherein the ECG analysis results include a cardiac event risk factor of low, intermediate, or high based upon the value of the at least one cardiac event risk factor.

21. A method for analyzing ECG measurements obtained from a patient to determine a patient risk factor corresponding to a level of risk of the patient experiencing a subsequent cardiac event, the method comprising the steps of:

(a) obtaining orthogonal ECG measurements of a patient with 3D ECG measuring equipment; and

(b) providing the obtained ECG measurements to ECG analysis equipment that receives the ECG measurements, performs an ECG analysis, and provides ECG analysis results in a user readable format;

wherein the ECG analysis includes determining at least one cardiac event risk factor having a value, the at least one cardiac event risk factor being determinable from one or more cardiac vector values selected from: sum magnitude of absolute QRST integral (SAI QRST), R/T peaks volume, spatial QRST angle, T-T′ angles, R-R′ angles, T-axes amplitudes, R-axes amplitudes, QRS loops areas, T loops areas, beat-to-beat variability in sum magnitude of absolute QRST integral (SAI QRST), beat-to-beat variability in R/T peaks volume, beat-to-beat variability in spatial QRST angle, beat-to-beat variability in T-T′ angles, beat-to-beat variability in R-R′ angles, beat-to-beat variability in T-axes amplitudes, beat-to-beat variability in R-axes amplitudes, beat-to-beat variability in QRS loops areas, and beat-to-beat variability in T loops areas, and

wherein the cardiac event risk factor is a low frequency SAI QRST determined by calculating the SAI QRST of orthogonal ECG measurements taken in the 10 Hz to 50 Hz band.

22. A method for analyzing ECG measurements obtained from a patient to determine a patient risk factor corresponding to a level of risk of the patient experiencing a subsequent cardiac event, the method comprising the steps of:

(a) obtaining ECG measurements of a patient with 3D ECG measuring equipment; and

(b) providing the obtained ECG measurements to ECG analysis equipment that receives the ECG measurements, performs an ECG analysis, and provides ECG analysis results in a user readable format;

wherein the ECG analysis includes determining at least one cardiac event risk factor having a value, the at least one cardiac event risk factor being determinable from one or more cardiac vector values selected from: sum magnitude of absolute QRST integral (SAI QRST), R/T peaks volume, spatial QRST angle, T-T′ angles, R-R′ angles, T-axes amplitudes, R-axes amplitudes, QRS loops areas, T loops areas, beat-to-beat variability in sum magnitude of absolute QRST integral (SAI QRST), beat-to-beat variability in R/T peaks volume, beat-to-beat variability in spatial QRST angle, beat-to-beat variability in T-T′ angles, beat-to-beat variability in R-R′ angles, beat-to-beat variability in T-axes amplitudes, beat-to-beat variability in R-axes amplitudes, beat-to-beat variability in QRS loops areas, and beat-to-beat variability in T loops areas,

wherein the ECG measurement equipment includes a surface ECG instrument or the ECG measurement equipment includes an intracardiac electrogram instrument, and

wherein the cardiac event risk factor is a SAI QRST that is determined by plotting a QRST curve for the ECG data or for the ECG measurements,

and calculated via the total sum of the absolute areas under the QRST curve.