Atrial arrhythmia episode detection in a cardiac medical device

• US 10,045,710 B2
• Filed: 03/30/2016
• Issued: 08/14/2018
• Est. Priority Date: 03/30/2016
• Status: Active Grant

• Current Assignee: Medtronic Incorporated (Medtronic Plc)
• Original Assignee: Medtronic Incorporated (Medtronic Plc)
• Inventors: Higgins, Elise J., Brown, Mark L., Cao, Jian
• Primary Examiner(s): Tejani, Ankit D
• Application Number:
  US15/084,511
• Publication Number:
  US 20170281033A1
• Time in Patent Office: 867 Days
• Field of Search: None
• CPC Class Codes: A61B 2560/028 Arrangements to prevent overuse, e.g. by counting the number of uses
• CPC Class Codes: A61B 5/002 Monitoring the patient using a local or closed circuit, e.g. in a room or building A61B5/0017 takes precedence
• CPC Class Codes: A61B 5/02405 Determining heart rate variability
• CPC Class Codes: A61B 5/287 Holders for multiple electrodes, e.g. electrode catheters for electrophysiological study [EPS]
• CPC Class Codes: A61B 5/316 Modalities, i.e. specific diagnostic methods
• CPC Class Codes: A61B 5/352 Detecting R peaks, e.g. for synchronising diagnostic apparatus; Estimating R-R interval
• CPC Class Codes: A61B 5/361 Detecting fibrillation
• CPC Class Codes: A61B 5/363 Detecting tachycardia or bradycardia
• CPC Class Codes: A61B 5/366 Detecting abnormal QRS complex, e.g. widening
• CPC Class Codes: A61B 5/4836 Diagnosis combined with treatment in closed-loop systems or methods A61B5/0036 takes precedence
• CPC Class Codes: A61B 5/7264 Classification of physiological signals or data, e.g. using neural networks, statistical classifiers, expert systems or fuzzy systems neural networks per se G06N3/00; expert systems per se G06N5/00
• CPC Class Codes: A61N 1/3925 Monitoring; Protecting
• CPC Class Codes: A61N 1/395 for treating atrial fibrillation
• CPC Class Codes: A61N 1/3956 Implantable devices for applying electric shocks to the heart, e.g. for cardioversion
• CPC Class Codes: A61N 1/39622 Pacing therapy
• CPC Class Codes: A61N 1/3987 characterised by the timing or triggering of the shock
• CPC Class Codes: G16H 50/20 for computer-aided diagnosis, e.g. based on medical expert systems

Abstract

A medical device is configured to detect an atrial tachyarrhythmia episode. The device senses a cardiac signal, identifies R-waves in the cardiac signal attendant ventricular depolarizations and determines classification factors from the R-waves identified over a predetermined time period. The device classifies the predetermined time period as one of unclassified, atrial tachyarrhythmia and non-atrial tachyarrhythmia by comparing the determined classification factors to classification criteria. A classification criterion is adjusted from a first classification criterion to a second classification criterion after at least one time period being classified as atrial tachyarrhythmia. An atrial tachyarrhythmia episode is detected by the device in response to at least one subsequent time period being classified as atrial tachyarrhythmia based on the adjusted classification criterion.

Claims

1. A method of detecting an atrial tachyarrhythmia episode in a medical device, comprising:

sensing a cardiac signal;

identifying R-waves in the cardiac signal attendant to ventricular depolarizations;

determining classification factors from the R-waves identified over a first predetermined time period;

classifying the first predetermined time period as atrial tachyarrhythmia based on comparing the determined classification factors to classification criteria;

adjusting a classification criterion of the classification criteria from a first classification criterion to a second classification criterion after classifying the first time period as atrial tachyarrhythmia;

classifying at least one subsequent time period as atrial tachyarrhythmia by comparing classification factors determined over the subsequent time period to the adjusted classification criterion; and

detecting an atrial tachyarrhythmia episode after adjusting the classification criterion and in response to both of the first predetermined time period being classified as atrial tachyarrhythmia based on the first classification criterion and the at least one subsequent time period being classified as atrial tachyarrhythmia based on the adjusted classification criterion.

2. The method of claim 1, wherein adjusting the classification criterion after the first time period being classified as atrial tachyarrhythmia comprises:

classifying at least a second predetermined time period by comparing classification factors determined over the second predetermined time period to the classification criteria before the adjusting; and

adjusting the classification criterion in response to the second predetermined time period being classified as one of atrial tachyarrhythmia and unclassified.

3. The method of claim 1, wherein adjusting the classification criterion after the first time period being classified as atrial tachyarrhythmia comprises:

classifying a plurality of consecutive predetermined time periods following the first time period by comparing classification factors determined over each of the plurality of consecutive predetermined time periods to the classification criteria before the adjusting; and

adjusting the classification criterion in response to none of the plurality of consecutive predetermined time periods being classified as non-atrial tachyarrhythmia.

4. The method of claim 1, wherein adjusting the classification criterion comprises adjusting the classification criterion in response to the first time period being classified as atrial tachyarrhythmia.

5. The method of claim 1, wherein:

determining the classification factors comprises determining RR-intervals between successive R-waves in the sensed cardiac signal and determining a variability metric of the RR-intervals;

classifying the first time period comprises classifying the first time period as atrial tachyarrhythmia when the variability metric meets a threshold; and

adjusting the classification criterion from a first classification criterion to a second classification criterion comprises adjusting the threshold of the variability metric from a first value to a second value less than the first value.

6. The method of claim 1, further comprising:

resetting the classification criterion from the second criterion to the first criterion in response to one of at least one subsequent time period being classified as non-atrial tachyarrhythmia.

7. The method of claim 1, further comprising:

resetting the classification criterion from the second criterion to the first criterion in response to a predetermined number of the subsequent time periods being classified as unclassified.

8. The method of claim 1, further comprising:

classifying a second time period after detecting the atrial tachyarrhythmia episode; and

detecting termination of the atrial tachyarrhythmia episode in response to classifying the second time period as non-atrial tachyarrhythmia.

9. The method of claim 8, further comprising:

resetting the classification criterion from the second criterion to the first criterion in response to detecting the termination.

10. The method of claim 1, further comprising:

classifying a plurality of time periods after detecting the atrial tachyarrhythmia episode using the adjusted classification criterion;

detecting termination of the atrial tachyarrhythmia episode in response to a predetermined number of the plurality of time periods being classified as unclassified; and

resetting the classification criterion from the second criterion to the first criterion in response to detecting the termination.

11. The method of claim 1, wherein:

determining the classification factors comprises determining whether a ventricular tachyarrhythmia detection is occurring during the at least one subsequent predetermined time period; and

classifying the subsequent predetermined time period as unclassified when the ventricular tachyarrhythmia detection is occurring during the subsequent predetermined time period.

12. The method of claim 1, further comprising responding to detecting the atrial tachyarrhythmia by at least one of transmitting atrial tachyarrhythmia episode data to another device and withholding a ventricular therapy in response to detecting the atrial tachyarrhythmia.

13. The method of claim 1, wherein detecting the atrial tachyarrhythmia episode comprises classifying a predetermined number of time periods as atrial tachyarrhythmia comprising at least a second time period after the first time period being classified as atrial tachyarrhythmia based on the first criterion and at least a third time period after the second time period classified as atrial tachyarrhythmia based on the second criterion.

14. The method of claim 1, wherein

determining the classification factors comprises determining RR-intervals between successive R-waves in the sensed cardiac signal and determining a variability metric of the RR-intervals having a maximum possible value of 100;

classifying the first predetermined time period as atrial tachyarrhythmia by comparing the variability metric to an atrial fibrillation score threshold; and

adjusting the classification criterion comprises adjusting the atrial fibrillation score threshold from the first value to the second value, wherein the first value is at least 25 and equal to or less than 75 and the second value is at least 19 and less than or equal to 60, and wherein the second value is less than the first value.

15. The method of claim 1, wherein classifying at least one subsequent time period comprises classifying the at least one subsequent time period as one of atrial tachyarrhythmia, non-atrial tachyarrhythmia, or unclassified by comparing classification factors determined over the subsequent time period to the adjusted classification criterion.

16. A medical device for detecting an atrial tachyarrhythmia episode, comprising:

sensing circuitry configured to receive a cardiac signal from a plurality of electrodes coupled to the medical device; and

a processor configured to;

identify R-waves in the cardiac signal attendant to ventricular depolarizations;

determine classification factors from the R-waves identified over a first predetermined time period;

classify the first predetermined time period as atrial tachyarrhythmia based on comparing the determined classification factors to classification criteria;

adjust a classification criterion of the classification criteria from a first classification criterion to a second classification criterion after the first time period being classified as atrial tachyarrhythmia;

classify at least one subsequent time period as atrial tachyarrhythmia by comparing classification factors determined over the subsequent time period to the adjusted classification criterion; and

detect an atrial tachyarrhythmia episode after adjusting the classification criterion and in response to both of the first predetermined time period being classified as atrial tachyarrhythmia based on the first classification criterion and the at least one subsequent time period being classified as atrial tachyarrhythmia based on the adjusted classification criterion.

17. The device of claim 16, wherein the processor is configured to adjust the classification criterion after the first time period being classified as atrial tachyarrhythmia by:

classifying at least a second predetermined time period by comparing classification factors determined over the second predetermined time period to the classification criteria before the adjusting; and

adjusting the classification criterion in response to the second predetermined time period not being classified as one of atrial tachyarrhythmia and unclassified.

18. The device of claim 16, wherein the processor is configured to adjust the classification criterion after the first time period being classified as atrial tachyarrhythmia by:

classifying a plurality of consecutive predetermined time periods following the first time period by comparing classification factors determined over each of the plurality of consecutive predetermined time periods to the classification criteria before the adjusting; and

adjusting the classification criterion in response to none of the plurality of consecutive predetermined time periods being classified as non-atrial tachyarrhythmia.

19. The device of claim 18, wherein the first time period and the plurality of consecutive predetermined time periods have a total duration greater than or equal to two minutes and less than or equal to ten minutes.

20. The device of claim 16, wherein the processor is configured to adjust the classification criterion in response to the first time period being classified as atrial tachyarrhythmia.

21. The device of claim 16, wherein the processor is further configured to:

determine the classification factors by determining RR-intervals between successive R-waves in the sensed cardiac signal and determining a variability metric of the RR-intervals;

classify the first time period by classifying the first time period as atrial tachyarrhythmia when the variability metric meets a threshold; and

adjust the classification criterion from a first classification criterion to a second classification criterion by adjusting the threshold of the variability metric from a first value to a second value less than the first value.

22. The device of claim 16, wherein the processor is further configured to:

reset the classification criterion from the second criterion to the first criterion in response to one of the at least one subsequent time periods being classified as non-atrial tachyarrhythmia.

23. The device of claim 16, wherein the processor is further configured to:

reset the classification criterion from the second criterion to the first criterion in response to a predetermined number of the subsequent time periods being classified as unclassified.

24. The device of claim 16, wherein the processor is further configured to:

classify a second time period after detecting the atrial tachyarrhythmia episode based on the second classification criterion; and

detect termination of the atrial tachyarrhythmia episode in response to classifying the second time period as non-atrial tachyarrhythmia.

25. The device of claim 24, wherein the processor is further configured to:

reset the classification criterion from the second criterion to the first criterion in response to detecting the termination.

26. The device of claim 16, wherein the processor is further configured to:

classify a plurality of time periods after detecting the atrial tachyarrhythmia episode using the adjusted classification criterion;

detect termination of the atrial tachyarrhythmia episode in response to a predetermined number of the plurality of time periods being classified as unclassified; and

reset the classification criterion from the second criterion to the first criterion in response to detecting the termination.

27. The device of claim 16, wherein the processor is further configured to:

determine at least one of the classification factors by determining whether a ventricular tachyarrhythmia detection is occurring during the first predetermined time period; and

classify the first predetermined time period as unclassified when the ventricular tachyarrhythmia detection is occurring during the first predetermined time period.

28. The device of claim 16, further comprising a therapy output circuit and a telemetry circuit, wherein the processor is further configured to provide a response to detecting the atrial tachyarrhythmia by at least one of controlling the telemetry circuit to transmit atrial tachyarrhythmia episode data to another device and controlling the therapy output circuit to withhold a ventricular therapy in response to detecting the atrial tachyarrhythmia.

29. The device of claim 16, wherein the processor is configured to detect the atrial tachyarrhythmia episode by classifying a predetermined number of time periods as atrial tachyarrhythmia comprising at least a second time period after the first time period being classified as atrial tachyarrhythmia based on the first criterion and at least a third time period after the second time period classified as atrial tachyarrhythmia based on the second criterion.

30. The device of claim 16, wherein the processor is further configured to:

determine one of the classification factors by determining RR-intervals between successive R-waves in the sensed cardiac signal and determining a variability metric of the RR-intervals having a maximum possible value of 100;

classify the first predetermined time period by comparing the variability metric to an atrial fibrillation score threshold; and

adjust the classification criterion by adjusting the atrial fibrillation score threshold from the first value to the second value, wherein the first value is at least 25 and equal to or less than 75 and the second value is at least 19 and less than or equal to 60 and wherein the second value is less than the first value.

31. The device of claim 16, wherein the plurality of electrodes are carried by an extra-cardiovascular lead.

32. The device of claim 16, wherein classifying at least one subsequent time period comprises classifying the at least one subsequent time period as one of atrial tachyarrhythmia, non-atrial tachyarrhythmia, or unclassified by comparing classification factors determined over the subsequent time period to the adjusted classification criterion.

33. A non-transitory, computer-readable storage medium storing instructions for causing a processor included in a medical device to perform a method for detecting an atrial tachyarrhythmia episode, the method comprising:

sensing a cardiac signal;

identifying R-waves in the cardiac signal attendant to ventricular depolarizations;

determining classification factors from the R-waves identified over a first predetermined time period;

classifying the first predetermined time period as atrial tachyarrhythmia based on comparing the determined classification factors to classification criteria;

adjusting a classification criterion of the classification criteria from a first classification criterion to a second classification criterion after classifying at least the first time period as atrial tachyarrhythmia;

classifying at least one subsequent time period as one of unclassified, atrial tachyarrhythmia and non-atrial tachyarrhythmia by comparing classification factors determined over the subsequent time period to the adjusted classification criterion; and

detecting an atrial tachyarrhythmia episode after adjusting the classification criterion and in response to both of the first predetermined time period being classified as atrial tachyarrhythmia based on the first classification criterion and the at least one subsequent time period being classified as atrial tachyarrhythmia based on the adjusted classification criterion.