ELECTROGRAM CLASSIFICATION ALGORITHM

• US 20130096449A1
• Filed: 10/14/2011
• Published: 04/18/2013
• Est. Priority Date: 10/14/2011
• Status: Active Grant

• Current Assignee: Medtronic Incorporated (Medtronic Plc)
• Original Assignee: Medtronic Incorporated (Medtronic Plc)
• Inventors: Patel, Amisha S., Cao, Jian, Kleckner, Karen J.
• Granted Patent: US 8,521,281 B2
• Time in Patent Office: Days
• US Class Current: 600/516
• CPC Class Codes: A61B 5/0031 Implanted circuitry
• CPC Class Codes: A61B 5/361 Detecting fibrillation
• CPC Class Codes: A61B 5/363 Detecting tachycardia or bradycardia
• CPC Class Codes: A61B 5/364 Detecting abnormal ECG interval, e.g. extrasystoles, ectopic heartbeats
• CPC Class Codes: A61N 1/37 Monitoring; Protecting
• CPC Class Codes: A61N 1/39622 Pacing therapy

Abstract

The present disclosure is directed to the classification of cardiac episodes using an algorithm. In various examples, an episode classification algorithm evaluates electrogram signal data using a probabilistic ventricular oversensing algorithm. The algorithm may look at a plurality of factors weighing for and against a determination of ventricular oversensing. In some examples, the algorithm may also determine whether the cardiac episode includes atrial sensing issues.

Claims

1. A method comprising:

receiving EGM signal data for a cardiac episode detected by an implantable medical device (IMD), wherein the EGM signal data includes at least ventricular sensed events and atrial sensed events;

determining, based on a probabilistic analysis, whether the EGM signal data indicates ventricular over-sensing (VOS), wherein a determination that the EGM signal data indicates VOS comprises classifying the cardiac episode as inappropriately shocked;

determining, in response to a determination that the EGM signal data does not indicate VOS, whether the EGM signal data indicates an atrial sensing issue, the atrial sensing issue including one of atrial over-sensing or atrial under-sensing, wherein;

in response to a determination of the atrial sensing issue, the method further comprises determining whether the atrial sensing issues are repairable;

in response to a determination that the atrial sensing issues are repairable, the method further comprises repairing the sensing issues and classifying the cardiac episode based on a set of classification rules that consider both the ventricular and atrial sensed events;

in response to a determination that the atrial sensing issues are not repairable, the method further comprises classifying the cardiac episode based on at least one classification rule that considers the ventricular sensed events but not the atrial sensed events; and

the classification of the cardiac episode comprises one of ventricular tachycardia/ventricular fibrillation, inappropriately shocked, or indeterminate.

2. The method of claim 1, wherein, determining, based on the probabilistic analysis, whether the EGM signal data indicates VOS comprises:

determining, based on probabilistic analysis, whether the EGM signal data indicates T-wave over-sensing (TWOS).

3. The method of claim 1, wherein determining, based on the probabilistic analysis, whether the EGM signal data indicates VOS comprises:

evaluating each of a plurality of VOS criteria for the cardiac episode;

calculating a VOS evidence value based on the evaluation of each of the plurality of VOS criteria, wherein a first one of the plurality of VOS criteria is given a first non-zero weight and a second one of the plurality of VOS criteria is given a second, different, non-zero weight;

identifying the cardiac episode, based at least on the VOS value, as non-VOS, or VOS; and

classifying the cardiac episode, in response to a non-VOS identification, based on one or more classification rules.

4. The method of claim 3, wherein the ventricular over-sensing criteria include criteria weighted against a finding of ventricular over-sensing, the criteria weighted against a finding of ventricular over-sensing comprising:

at least a first predetermined number of intervals between approximately 160 ms and approximately 270 ms;

at least a second predetermined number of intervals between approximately 270 ms and approximately 350 ms;

less than a third predetermined number of intervals greater than approximately 350 ms;

consistent slew rate for the sensed ventricular events;

a first combination of

a low frequency content EGM signal,

no evidence of EGM saturation, and

a determination of no TWOS;

a second combination of

a sudden onset of V to V interval rate change wherein the V to V interval rate increases and remains at an increased level,

a determination of no TWOS, and

no VOS found on a far-field EGM signal; and

a third combination of

a determination of a regular episode

a determination of a regular rhythm; and

no intervals less than or equal to approximately 130 ms;

wherein at least the first combination, the second combination, and the third combination are each given different weights.

5. The method of claim 3, wherein the ventricular over-sensing criteria includes criteria weighted for a finding of ventricular over-sensing, the criteria weighted for a finding of ventricular over-sensing comprising:

a determination of TWOS;

a finding of R-wave over-sensing (RWOS); and

inconsistent slew rate for the ventricular sensed events;

wherein the determination of TWOS, the finding of RWOS and inconsistent slew rate for ventricular sensed events are each given different weights.

6. The method of claim 3, further comprising detecting an EGM noise level, wherein the EGM noise level comprises one of not noisy, noisy, very noisy, extremely noisy or saturation, wherein the EGM noise level is evidence for or against a finding of VOS, and wherein the EGM noise level of noisy has a different weight of evidence than the EGM noise level of very noisy.

7. The method of claim 1, wherein the at least one classification rule that considers the ventricular sensed events but not the atrial sensed events is at least one of:

V-V interval extremely regular,

fast V-V interval,

rhythm after pacing is VT/VF,

low-frequency V signal,

ventricular morphology rules; and

atrial fibrillation (AF) characteristics.

8. The method of claim 1, wherein classification of the cardiac episode further comprising determining whether the cardiac episode indicates atrial fibrillation (AF), the determination comprising:

identifying a predetermined number of ventricular sensed events immediately prior to diagnosis by the IMD;

determining whether the EGM signal data spanning the predetermined number of ventricular sensed events includes one or more AF characteristics, the AF characteristics including;

at least one atrial interval greater than a first predetermined threshold,

an amplitude for any atrial sensed events less than a second predetermined threshold,

at least one atrial interval less than a third predetermined interval;

an atrial interval spanning diagnosis and greater in length than the first predetermined interval, or

irregular ventricular intervals; and

classifying the cardiac episode, based on the determined characteristics, as AF.

9. The method of claim 8, wherein the cardiac episode is classified as AF in response to a determination that at least 3 of the AF characteristics have been met.

10. The method of claim 8, wherein the first predetermined threshold is approximately 1800 ms.

11. The method of claim 8, wherein the second predetermined threshold is approximately 2 millivolts.

12. The method of claim 8, wherein the third predetermined threshold is approximately 200 ms.

13. The method of claim 8, wherein the cardiac episode is classified as AF in response to irregular intervals and normal atrial sensing at termination, wherein normal atrial sensing at termination includes at least five atrial sensed events prior to termination and no atrial intervals greater than approximately 1800 ms in the five atrial sensed events.

14. The method of claim 1, further comprising

determining whether the cardiac episode includes a diagnosis of a of a tachyarrhythmia by the implantable medical device in the presence of pacing;

determining if the EGM signal data indicates the cardiac episode includes a rapid ventricular rate and atrial pacing; and

classifying the cardiac episode as ventricular tachycardia/ventricular fibrillation (VT/VF) or supraventricular tachycardia (SVT) based on the EGM signal data, wherein classifying the cardiac episode comprises;

classifying the cardiac episode as VT/VF in response to the cardiac episode including at least one of;

a period of fast ventricular rate with no atrial sensing, or an indication of the ventricle transitioning out of a pacing pattern first; and

classifying the cardiac episode as SVT in response to the cardiac episode including at least one of;

atrial fibrillation characteristics prior to a diagnosis by the implantable medical device, or an indication of the atria transitioning out of the pacing pattern first.

15. A system comprising:

a communication module configured to receive EGM signal data for a cardiac episode detected by an implantable medical device (IMD), wherein the EGM signal data includes at least ventricular sensed events and atrial sensed events; and

a processor configured to;

determine, based on a probabilistic analysis, whether the EGM signal data indicates ventricular over-sensing (VOS), wherein the determination is based at least in part on a probabilistic determination of whether the EGM signal data indicates T-wave over-sensing (TWOS) and wherein a determination of VOS comprises classifying the cardiac episode as inappropriately shocked;

determine, in response to a determination of no VOS, whether the EGM signal data indicates an atrial sensing issue, the atrial sensing issue including one of atrial over-sensing or atrial under-sensing, wherein

in response to a determination of the atrial sensing issue, determine whether the atrial sensing issues are repairable,

in response to a determination that the atrial sensing issues are repairable, repair the sensing issues and classifying the cardiac episode based on a set of classification rules that consider both the ventricular and atrial sensed events;

in response to a determination that the atrial sensing issues are not repairable, classify the cardiac episode based on at least one classification rule that considers the ventricular sensed events but not the atrial sensed events; and

wherein the classification comprises ventricular tachycardia/ventricular fibrillation, inappropriately shocked, or indeterminate.

16. The system of claim 15, wherein the processor is further configured perform the probabilistic analysis of VOS by

evaluating each of a plurality of ventricular over-sensing criteria for the cardiac episode;

calculating a ventricular over-sensing evidence value based on the evaluation of each of the plurality of ventricular over-sensing criteria, wherein a first one of the plurality of ventricular over-sensing criteria is given a first non-zero weight and a second one of the plurality of ventricular over-sensing criteria is given a second, different, non-zero weight;

identifying the cardiac episode, based at least on the ventricular over-sensing value, as non-ventricular over-sensing, maybe ventricular over-sensing, or likely ventricular over-sensing; and

classifying the cardiac episode, in response to a non-ventricular over-sensing identification, based on the set of classification rules.

17. The system of claim 16, wherein the ventricular over-sensing criteria includes criteria weighted against a finding of ventricular over-sensing, the criteria weighted against a finding of ventricular over-sensing comprising:

at least a first predetermined number of intervals between approximately 160 ms and approximately 270 ms;

at least a second predetermined number of intervals between approximately 270 ms and approximately 350 ms;

less than a third predetermined number of intervals greater than approximately 350 ms;

consistent slew rate for the sensed ventricular events;

a first combination of

a low frequency content EGM signal,

no evidence of EGM saturation, and

a determination of no TWOS;

a second combination of

a sudden onset of V to V interval rate change wherein the V to V interval rate increases and remains at an increased level,

a determination of no TWOS, and

no VOS found on a far-field EGM signal; and

a third combination of

a determination of a regular episode

a determination of a regular rhythm; and

no intervals less than or equal to approximately 130 ms;

wherein the processor is further configured to give each of at least the first combination, the second combination, and the third combination different weights.

18. The system of claim 16, wherein the ventricular over-sensing criteria includes criteria weighted for a finding of ventricular over-sensing, the criteria weighted for a finding of ventricular over-sensing comprising:

a determination of TWOS;

a finding of R-wave over-sensing (RWOS); and

inconsistent slew rate for the ventricular sensed events;

wherein the processor is further configured to give the determination of TWOS, the finding of RWOS, and inconsistent slew rate for ventricular sensed events each different weights.

19. The system of claim 16, wherein the processor is further configured to detect an EGM noise level, wherein the EGM noise level comprises one of not noisy, noisy, very noisy, extremely noisy or saturation, wherein the EGM noise level is evidence for or against a finding of VOS, and wherein processor is further configured to give the EGM noise level of noisy a different weight of evidence than the EGM noise level of very noisy.

20. The system of claim 15, wherein the at least one classification rule that considers the ventricular sensed events but not the atrial sensed events is at least one of:

V-V interval extremely regular,

fast V-V interval,

rhythm after pacing is VT/VF,

low-frequency V signal,

ventricular morphology rules; and

atrial fibrillation (AF) characteristics.

21. The system of claim 15, wherein the processor is further configured to determine whether the cardiac episode indicates atrial fibrillation (AF), the determination comprising:

identifying a predetermined number of ventricular sensed events immediately prior to diagnosis by the IMD;

determining whether the EGM signal data spanning the predetermined number of ventricular sensed events includes one or more AF characteristics, the AF characteristics including;

at least one atrial interval greater than a first predetermined threshold,

an amplitude for any atrial sensed events less than a second predetermined threshold,

at least one atrial interval less than a third predetermined interval;

an atrial interval spanning diagnosis and greater in length than the first predetermined interval, or

irregular ventricular intervals; and

classifying the cardiac episode, based on the determined characteristics, as AF.

22. The system of claim 21, wherein the cardiac episode is classified as AF in response to a determination that at least 3 of the AF characteristics have been met.

23. The system of claim 21, wherein the first predetermined threshold is approximately 1800 ms.

24. The system of claim 21, wherein the second predetermined threshold is approximately 2 millivolts.

25. The system of claim 21, wherein the third predetermined threshold is approximately 200 ms.

26. The system of claim 21, wherein the processor is further configured to classify the cardiac episode as AF in response to irregular intervals and normal atrial sensing at termination, wherein normal atrial sensing at termination includes at least five atrial sensed events prior to termination and no atrial intervals greater than approximately 1800 ms in the five atrial sensed events.

27. The system of claim 15, wherein the processor is further configured to:

determine whether the cardiac episode includes a diagnosis of a of a tachyarrhythmia by the implantable medical device in the presence of pacing;

determine if the EGM signal data indicates the cardiac episode includes a rapid ventricular rate and atrial pacing; and

classify the cardiac episode as ventricular tachycardia/ventricular fibrillation (VT/VF) or supraventricular tachycardia (SVT) based on the EGM signal data, wherein classifying the cardiac episode comprises;

classify the cardiac episode as VT/VF in response to the cardiac episode including at least one of;

a period of fast ventricular rate with no atrial sensing, or an indication of the ventricle transitioning out of a pacing pattern first; and

classify the cardiac episode as SVT in response to the cardiac episode including at least one of;

atrial fibrillation characteristics prior to a diagnosis by the implantable medical device, or an indication of the atria transitioning out of the pacing pattern first.

28. A system comprising:

means for receiving EGM signal data for a cardiac episode detected by an implantable medical device (IMD), wherein the EGM signal data includes at least ventricular sensed events and atrial sensed events;

means for determining, based on a probabilistic analysis, whether the EGM signal data indicates ventricular over-sensing (VOS), wherein a determination that the EGM signal data indicates VOS comprises classifying the cardiac episode as inappropriately shocked;

means for determining, in response to a determination that the EGM signal data does not indicate VOS, whether the EGM signal data indicates an atrial sensing issue, the atrial sensing issue including one of atrial over-sensing or atrial under-sensing, wherein;

in response to a determination of the atrial sensing issue, the method further comprises determining whether the atrial sensing issues are repairable;

in response to a determination that the atrial sensing issues are repairable, the method further comprises repairing the sensing issues and classifying the cardiac episode based on a set of classification rules that consider both the ventricular and atrial sensed events;

in response to a determination that the atrial sensing issues are not repairable, the method further comprises classifying the cardiac episode based on at least one classification rule that considers the ventricular sensed events but not the atrial sensed events; and

the classification of the cardiac episode comprises one of ventricular tachycardia/ventricular fibrillation, inappropriately shocked, or indeterminate.

29. A computer-readable medium comprising instructions for causing a programmable processor to:

receive EGM signal data for a cardiac episode detected by an implantable medical device (IMD), wherein the EGM signal data includes at least ventricular sensed events and atrial sensed events;

determine, based on a probabilistic analysis, whether the EGM signal data indicates ventricular over-sensing (VOS), wherein the determination is based at least in part on a probabilistic determination of whether the EGM signal data indicates T-wave over-sensing (TWOS) and wherein a determination of VOS comprises classifying the cardiac episode as inappropriately shocked;

determine, in response to a determination of no VOS, whether the EGM signal data indicates an atrial sensing issue, the atrial sensing issue including one of atrial over-sensing or atrial under-sensing, wherein

in response to a determination of the atrial sensing issue, determine whether the atrial sensing issues are repairable,

in response to a determination that the atrial sensing issues are repairable, repair the sensing issues and classifying the cardiac episode based on a set of classification rules that consider both the ventricular and atrial sensed events;

in response to a determination that the atrial sensing issues are not repairable, classify the cardiac episode based on at least one classification rule that considers the ventricular sensed events but not the atrial sensed events; and

wherein the classification comprises ventricular tachycardia/ventricular fibrillation, inappropriately shocked, or indeterminate.