Asystole detection and response in an implantable cardioverter defibrillator

• US 10,130,824 B2
• Filed: 04/29/2016
• Issued: 11/20/2018
• Est. Priority Date: 04/28/2016
• Status: Active Grant

• Current Assignee: Medtronic Incorporated (Medtronic Plc)
• Original Assignee: Medtronic Incorporated (Medtronic Plc)
• Inventors: Grinberg, Yanina, Sawchuk, Robert T., Thompson-Nauman, Amy E., Peterson, Douglas A., Solheim, Paul R., Lauer, Joel R.
• Primary Examiner(s): Levicky, William
• Application Number:
  US15/142,074
• Publication Number:
  US 20170312533A1
• Time in Patent Office: 935 Days
• CPC Class Codes: A61N 1/3621 for treating or preventing abnormally high heart rate
• CPC Class Codes: A61N 1/371 Capture, i.e. successful stimulation
• CPC Class Codes: A61N 1/37217 characterised by the communication link, e.g. acoustic or tactile
• CPC Class Codes: A61N 1/37258 Alerting the patient
• CPC Class Codes: A61N 1/3925 Monitoring; Protecting
• CPC Class Codes: A61N 1/3956 Implantable devices for applying electric shocks to the heart, e.g. for cardioversion
• CPC Class Codes: A61N 1/3962 in combination with another heart therapy
• CPC Class Codes: A61N 1/3987 characterised by the timing or triggering of the shock

Abstract

An implantable cardioverter defibrillator (ICD) receives a cardiac electrical signal by a sensing circuit while operating in a sensing without pacing mode and detects asystole based on the cardiac electrical signal. The ICD determines, in response to detecting the asystole, if asystole backup pacing is enabled, and automatically switches to a temporary pacing mode in response to the asystole backup pacing being enabled. Other examples of detecting asystole and providing a response to detecting asystole by the ICD are described herein.

Claims

1. An implantable cardioverter defibrillator (ICD) system, comprising:

a sensing circuit configured to receive a cardiac electrical signal via a sensing electrode vector and sense cardiac events from the cardiac electrical signal;

a therapy delivery circuit configured to deliver electrical pacing pulses to a heart of a patient via a pacing electrode vector; and

a control circuit coupled to the sensing circuit and the therapy delivery circuit and configured to automatically switch between a sensing without pacing mode and a temporary pacing mode, and further configured to;

detect asystole based on the cardiac electrical signal without delivering a pacing pulse in response to detecting the asystole while operating in the sensing without pacing mode,

in response to detecting the asystole, determine that asystole backup pacing is enabled, and

automatically switch to the temporary pacing mode in response to the asystole backup pacing being enabled.

2. The ICD system of claim 1, wherein the control circuit is configured to remain in the sensing without pacing mode in response to the asystole backup pacing mode not being enabled.

3. The ICD system of claim 1, further comprising:

a memory coupled to the control circuit; and

a telemetry circuit configured for bi-directional wireless communication with an external device,

wherein the control circuit is configured to

store a segment of the cardiac electrical signal in the memory in response to detecting the asystole, and

control the telemetry circuit to transmit the stored cardiac electrical signal segment to the external device.

4. The ICD system of claim 1, further comprising a memory coupled to the control circuit,

wherein the control circuit is configured to:

set a first asystole time interval in response to an R-wave sensed by the sensing circuit;

set a second asystole time interval in response to the sensed R-wave;

enable recording of a segment of the cardiac electrical signal in the memory in response to the first asystole time interval expiring without sensing a next R-wave by the sensing circuit during the first asystole time interval; and

detect the asystole in response to the second asystole time interval expiring without sensing a next R-wave by the sensing circuit during the second asystole time interval.

5. The ICD system of claim 4, wherein the second time interval is at least two seconds and the first time interval is shorter than the second time interval.

6. The ICD system of claim 1, wherein the control circuit is configured to:

detect a termination condition; and

switch from the temporary pacing mode back to the sensing without pacing mode upon detection of the termination condition.

7. The ICD system of claim 6, wherein:

the ICD further includes a telemetry circuit configured for bi-directional wireless communication with an external device; and

the control circuit is configured to detect the termination condition by detecting one of;

an expiration of a predetermined termination time interval;

a tachyarrhythmia episode;

a magnet applied over the ICD,

receipt of a termination command by the telemetry circuit,

a predetermined number of pacing pulses delivered during the temporary pacing mode, or

a predetermined number of sensed R-waves during the temporary pacing mode.

8. The ICD system of claim 1, wherein the control circuit is configured to control the therapy delivery circuit to:

set a pacing escape interval to a first value upon switching to the temporary pacing mode;

deliver up to a predetermined number of pacing pulses at a rate corresponding to the first value when an R-wave is not sensed by the sensing circuit during the pacing escape interval set to the first value;

set the pacing escape interval to a second value longer than the first value after a last one of the predetermined number of pacing pulses is delivered at the rate corresponding to the first value; and

deliver a subsequent pacing pulse at a rate corresponding to the second value when an R-wave is not sensed during the pacing escape interval set to the second value.

9. The ICD system of claim 1, wherein the control circuit is configured to control the therapy delivery circuit to:

set a pacing escape interval to a first value upon switching to the temporary pacing mode;

deliver up to a first predetermined number of first pacing pulses at a first rate corresponding to the first value of the pacing escape interval when an R-wave is not sensed by the sensing circuit during the pacing escape interval set to the first value;

set the pacing escape interval to a second value longer than the first value after the first predetermined number of pacing pulses are delivered at the first rate;

deliver up to a second predetermined number of second pacing pulses at a second rate corresponding to the second value of the pacing escape interval when an R-wave is not sensed during the pacing escape interval set to the second value;

set the pacing escape interval to a third value that is longer than the second value upon delivering a last one of the second predetermined number of second pacing pulses;

in response to the pacing escape interval set to the third value expiring without an R-wave sensed by the sensing circuit, deliver a third pacing pulse upon expiration of the pacing escape interval set to the third value; and

set the pacing escape interval to the second value in response to delivering the third pacing pulse.

10. The ICD system of claim 1, wherein the control circuit is configured to:

determine at least one rest condition;

determine whether the patient is in one of a rest state or a non-rest state based on the at least one rest condition;

in response to determining the patient being in the rest state, control the therapy delivery circuit to deliver asystole backup pacing according to a first setting of a pacing control parameter; and

in response to determining the patient is in the non-rest state, control the therapy delivery circuit to deliver asystole backup pacing according to a second setting of the pacing control parameter different than the first setting.

11. The ICD system of claim 10, wherein the ICD further comprises a sensor producing a signal correlated to at least one of patient activity or patient posture;

the control circuit being configured to determine the at least one rest condition by determining at least one of a time of day, a patient activity, or a patient posture.

12. The ICD system of claim 10, wherein the pacing control parameter is one of a pacing escape interval, a predetermined number of pacing pulses, a pacing pulse amplitude, a hysteresis interval, or a temporary pacing mode termination condition.

13. The ICD system of claim 1, wherein the control circuit is configured to:

detect a rest state of the patient during the sensing without pacing mode; and

in response to detecting the rest state, perform at least one of;

set an asystole detection timer to a first time interval that is longer than a second asystole detection timer used to detect asystole when a rest state is not detected;

or

withhold switching to the temporary asystole backup pacing mode.

14. The ICD system of claim 1, wherein the control circuit is configured to:

increase an asystole episode counter in response to detecting the asystole;

compare the asystole episode counter to a permanent pacing mode switch threshold;

in response to the permanent pacing mode switch threshold being reached, determine if switching to a permanent pacing mode is enabled;

switch from the sensing without pacing mode to the permanent pacing mode in response to switching to the permanent pacing mode being enabled; and

control the therapy delivery circuit to deliver cardiac pacing according to the permanent pacing mode.

15. The ICD system of claim 1, further comprising at least one of:

a patient notification circuit configured to generate a notification signal perceivable by the patient;

or

a telemetry circuit configured to transmit a notification signal to an external device,

wherein the control circuit is configured to control at least one of the patient notification circuit or the telemetry circuit to generate a notification in response to detecting the asystole episode.

16. The ICD system of claim 1, further comprising:

a memory coupled to the control circuit; and

a telemetry circuit configured for bi-directional wireless communication with an external device,

wherein the control circuit is configured to

store asystole episode data comprising a segment of the cardiac electrical signal in the memory with a date and time stamp in response to detecting the asystole, and

control the telemetry circuit to transmit the asystole episode data to the external device.

17. The ICD system of claim 16, wherein the control circuit is further configured to store the asystole episode data by:

determining and storing at least one of;

a total number of pacing pulses delivered during the temporary pacing mode;

a histogram of pacing intervals during the temporary pacing mode;

or

pacing capture verification data determined by verifying capture of at least one pacing pulse delivered during the temporary pacing mode.

18. The ICD system of claim 16, further comprising a sensor producing a signal correlated to at least one of patient activity or patient posture;

wherein the control circuit is further configured to store the asystole episode data by determining a patient rest condition from the sensor signal and storing the rest condition with the asystole episode data.

19. The ICD system of claim 1, further comprising an extra-cardiovascular lead configured to be coupled to the ICD, the extra-cardiovascular lead carrying at least one electrode of the extra-cardiovascular pacing electrode vector.

20. The ICD system of claim 1, wherein the control circuit is further configured to:

trigger the therapy delivery circuit to deliver a pacing pulse in response to a cardiac event being sensed by the sensing circuit after switching to the temporary pacing mode, the pacing pulse being delivered by the therapy delivery circuit within a physiological refractory period of the sensed cardiac event.

21. The ICD system of claim 1, wherein the control circuit is further configured to:

detect a tachyarrhythmia based on the cardiac electrical signal;

control the therapy delivery circuit to deliver an anti-tachyarrhythmia therapy comprising at least one of anti-tachycardia pacing or a shock followed by post-shock pacing; and

withhold switching from the sensing without pacing mode to the temporary pacing mode when one of the tachyarrhythmia is being detected or the anti-tachyarrhythmia therapy is being delivered.

22. A method performed by an implantable cardioverter defibrillator (ICD) system, comprising:

receiving a cardiac electrical signal from a heart of a patient by a sensing circuit of an ICD;

while operating in a sensing without pacing mode, detecting asystole by a control circuit of the ICD based on the cardiac electrical signal without delivering a pacing pulse in response to detecting the asystole;

in response to detecting the asystole, determining by the control circuit that asystole backup pacing is enabled, and

automatically switching to a temporary pacing mode in response to the asystole backup pacing being enabled.

23. The method of claim 22, further comprising remaining in the sensing without pacing mode in response to the asystole backup pacing mode not being enabled.

24. The method of claim 22, further comprising:

storing a segment of the cardiac electrical signal in a memory of the ICD in response to detecting the asystole, and

controlling a telemetry circuit of the ICD to transmit the stored cardiac electrical signal segment to an external device.

25. The method of claim 22, further comprising:

setting a first asystole time interval in response to an R-wave sensed by the sensing circuit;

setting a second asystole time interval in response to the sensed R-wave;

enabling recording of a segment of the cardiac electrical signal in a memory of the ICD in response to the first asystole time interval expiring without sensing a next R-wave by the sensing circuit during the first asystole time interval; and

detecting the asystole in response to the second asystole time interval expiring without sensing a next R-wave by the sensing circuit during the second asystole time interval.

26. The method of claim 25, wherein the second time interval is at least two seconds and the first time interval is shorter than the second time interval.

27. The method of claim 22, further comprising:

detecting a termination condition; and

switching from the temporary pacing mode back to the sensing without pacing mode upon detection of the termination condition.

28. The method of claim 27, wherein detecting the termination condition comprises detecting one of:

an expiration of a predetermined termination time interval;

a tachyarrhythmia episode;

a magnet applied over the ICD,

receipt of a termination command by a telemetry circuit of the ICD,

a predetermined number of pacing pulses delivered during the temporary pacing mode, or

a predetermined number of sensed R-waves during the temporary pacing mode.

29. The method of claim 22, further comprising:

setting a pacing escape interval to a first value upon switching to the temporary pacing mode;

delivering up to a predetermined number of pacing pulses at a rate corresponding to the first value when an R-wave is not sensed by the sensing circuit during the pacing escape interval set to the first value;

setting the pacing escape interval to a second value longer than the first value after a last one of the predetermined number of pacing pulses is delivered at the rate corresponding to the first value; and

delivering a subsequent pacing pulse at a rate corresponding to the second value when an R-wave is not sensed during the pacing escape interval set to the second value.

30. The method of claim 22, further comprising:

setting a pacing escape interval to a first value upon switching to the temporary pacing mode;

delivering up to a first predetermined number of first pacing pulses at a first rate corresponding to the first value of the pacing escape interval when an R-wave is not sensed by the sensing circuit during the first pacing escape interval;

setting the pacing escape interval to a second value longer than the first value after the first predetermined number of pacing pulses are delivered at the first rate;

delivering up to a second predetermined number of second pacing pulses at a second rate corresponding to the second value of the pacing escape interval when an R-wave is not sensed during the pacing escape interval set to the second value;

setting the pacing escape interval to a third value that is longer than the second value upon delivering a last one of the second predetermined number of second pacing pulses;

in response to the pacing escape interval set to the third value expiring without an R-wave sensed by the sensing circuit, delivering a third pacing pulse upon expiration of the pacing escape interval set to the third value; and

setting the pacing escape interval to the second value in response to delivering the third pacing pulse.

31. The method of claim 22, further comprising:

determining at least one rest condition;

determining whether the patient is in one of a rest state or a non-rest state based on the at least one rest condition;

in response to determining the patient being in the rest state, controlling a therapy delivery circuit of the ICD to deliver asystole backup pacing according to a first setting of a pacing control parameter; and

in response to determining the patient is in the non-rest state, control the therapy delivery circuit to deliver asystole backup pacing according to a second setting of the pacing control parameter different than the first setting.

32. The method of claim 31, further comprising determining the at least one rest condition by the control circuit of the ICD by determining at least one of a time of day, a patient activity from a signal produced by a sensor of the ICD, or a patient posture from a signal produced by a sensor of the ICD.

33. The method of claim 31, wherein the pacing control parameter is one of a pacing escape interval, a predetermined number of pacing pulses, a pacing pulse amplitude, a hysteresis interval, or a temporary pacing mode termination condition.

34. The method of claim 22, further comprising:

detecting a rest state of the patient during the sensing without pacing mode; and

in response to detecting the rest state, performing at least one of;

setting an asystole detection time interval to a first time interval that is longer than a second time interval used to detect asystole when a rest state is not detected;

or

withholding switching to the temporary pacing mode in response to detecting the asystole.

35. The method of claim 22, further comprising:

increasing an asystole episode counter in response to detecting the asystole;

comparing the asystole episode counter to a permanent pacing mode switch threshold; and

in response to the permanent pacing mode switch threshold being reached, determining if switching to a permanent pacing mode is enabled;

switching from the sensing without pacing mode to the permanent pacing mode in response to switching to the permanent pacing mode being enabled; and

controlling a therapy delivery circuit of the ICD to deliver cardiac pacing according to the permanent pacing mode.

36. The method of claim 22, further comprising:

controlling at least one of a patient notification circuit of the ICD or a telemetry circuit of the ICD to generate a notification in response to detecting the asystole episode,

the patient notification circuit configured to generate a patient notification signal perceivable by the patient, and the telemetry circuit configured to transmit the notification to an external device.

37. The method of claim 22, further comprising:

storing asystole episode data comprising a segment of the cardiac electrical signal in a memory of the ICD with a date and time stamp in response to detecting the asystole, and

controlling a telemetry circuit of the ICD to transmit the asystole episode data to an external device.

38. The method of claim 37, wherein storing the asystole episode data comprises determining and storing at least one of:

a total number of pacing pulses delivered during the temporary pacing mode;

a histogram of pacing intervals during the temporary pacing mode;

or

pacing capture verification data determined by verifying capture of at least one pacing pulse delivered during the temporary pacing mode.

39. The method of claim 37, wherein storing the asystole episode data further comprises determining a patient rest condition from a sensor signal and storing the rest condition with the asystole episode data.

40. The method of claim 22, further comprising controlling a therapy delivery circuit of the ICD to deliver asystole backup pacing during the temporary pacing mode via at least one electrode carried by an extra-cardiovascular lead coupled to the ICD.

41. The method of claim 22, further comprising triggering the therapy delivery circuit to deliver a pacing pulse in response to a cardiac event being sensed by the sensing circuit after switching to the temporary pacing mode, the pacing pulse being delivered by the therapy delivery circuit within a physiological refractory period of the sensed cardiac event.

42. The method of claim 22, further comprising:

detecting a tachyarrhythmia by the control circuit based on the cardiac electrical signal;

controlling the therapy delivery circuit to deliver an anti-tachyarrhythmia therapy comprising at least one of anti-tachycardia pacing or a shock followed by post-shock pacing; and

withholding switching from the sensing without pacing mode to the temporary pacing mode when one of the tachyarrhythmia is being detected or the anti-tachyarrhythmia therapy is being delivered.

43. A non-transitory, computer-readable storage medium comprising a set of instructions which, when executed by a control circuit of an implantable cardioverter defibrillator (ICD) system, cause the system to:

receive a cardiac electrical signal by a sensing circuit of an ICD;

while operating in a sensing without pacing mode, detect asystole based on the cardiac electrical signal without delivering a pacing pulse in response to detecting the asystole;

in response to detecting the asystole, determine that asystole backup pacing is enabled, and

automatically switch to a temporary pacing mode in response to the asystole backup pacing being enabled.