Implantable medical device for assessing heart failure state from Mechanical Pulsus Alternans

• US 6,915,157 B2
• Filed: 02/18/2003
• Issued: 07/05/2005
• Est. Priority Date: 02/18/2003
• Status: Active Grant

• Current Assignee: Medtronic Incorporated (Medtronic Plc)
• Original Assignee: Medtronic Incorporated (Medtronic Plc)
• Inventors: Abo-Auda, Wael, Bennett, Tommy D., Mulligan, Lawrence J., Hamlen, Robert C., Duffin, Edwin G.
• Primary Examiner(s): MANUEL, GEORGE C
• Application Number:
  US10/368,278
• Publication Number:
  US 20040162497A1
• Time in Patent Office: 868 Days
• Field of Search: 600/300, 600/513, 600/517, 607/9
• US Class Current: 600/513
• CPC Class Codes: A61B 5/0031 Implanted circuitry
• CPC Class Codes: A61B 5/0215 by means inserted into the body catheters A61M25/00
• CPC Class Codes: A61B 5/02405 Determining heart rate variability
• CPC Class Codes: A61B 5/0245 by using sensing means generating electric signals, i.e. ECG signals
• CPC Class Codes: A61B 5/349 Detecting specific parameters of the electrocardiograph cycle

Abstract

An implantable heart monitor (IHM) implanted in a patient'"'"'s body having electrogram (EGM) sense electrodes coupled with EGM sense circuitry to generate sense events upon detection of cardiac depolarizations and a blood pressure measurement transducer disposed in a heart chamber and coupled with blood pressure measurement circuitry operates to assess heart failure state as a function of mechanical pulsus alternans (MPA). MPA episodes are detected, and MPA characteristics of the MPA episode are used alone or as a group as a diagnostic marker of HF state. The MPA episode data set can be stored in memory associated with a time and date stamp. The MPA characteristics of each MPA data set in a series of MPA data sets collected over time can be compared or plotted to determine if a trend indicative of change in HF state is discernible.

Claims

1. A method of operation of an implantable heart monitor implanted in a patient'"'"'s body having electrogram (EGM) sense electrodes coupled with EGM sense circuitry to generate sense events upon detection of cardiac depolarizations and a blood pressure measurement transducer disposed in a heart chamber and coupled with blood pressure measurement circuitry to assess heart failure state as a function of mechanical pulsus alternans (MPA) comprising:

operating the blood pressure measurement transducer to make blood pressure measurements;

detecting the onset of an MPA episode of the patient'"'"'s heart from the blood pressure measurements;

determining at least one MPA characteristic of the MPA episode; and

assessing heart failure state from the MPA characteristic.

2. The method of claim 1, wherein the step of determining the at least one MPA characteristic further comprises determining an MPA onset heart rate associated with the detection of onset of the MPA episode.

3. The method of claim 2, wherein the assessing step further comprises comparing a series of stored MPA onset heart rates to determine if the stored MPA onset heart rates exhibit an increasing heart rate trend signifying an improving heart failure state, a decreasing heart rate trend signifying a deteriorating heart failure state or a substantially unchanging heart rate trend signifying a stable heart failure state.

4. The method of claim 1, further comprising the step of detecting the end of an MPA episode of the patient'"'"'s heart from the blood pressure measurements, and wherein the step of determining the at least one MPA characteristic further comprises determining an MPA end heart rate associated with the detection of the end of the MPA episode.

5. The method of claim 4, wherein the assessing step further comprises comparing a series of stored MPA end heart rates to determine if the stored MPA end heart rates exhibit an increasing heart rate trend signifying an improving heart failure state, a decreasing heart rate trend signifying a deteriorating heart failure state or a substantially unchanging heart rate trend signifying a stable heart failure state.

6. The method of claim 1, wherein the step of determining the MPA characteristic further comprises:

determining the differences between the systolic peak blood pressures of two heart beats as MPA magnitudes; and

determining a maximal MPA magnitude data point from the determined MPA magnitudes.

7. The method of claim 6, wherein the assessing step further comprises comparing a series of stored maximal MPA magnitude data points to determine if the stored maximal MPA magnitude data points exhibit a decreasing MPA magnitude trend signifying an improving heart failure state, an increasing MPA magnitude trend signifying a deteriorating heart failure state or a substantially unchanging MPA magnitude trend signifying a stable heart failure state.

8. The method of claim 1, wherein the step of determining the MPA characteristic further comprises:

determining the differences between the systolic peak blood pressures of two heart beats as MPA magnitudes; and

determining a mean MPA magnitude data point from the determined MPA magnitudes.

9. The method of claim 8, wherein the assessing step further comprises comparing a series of stored mean MPA magnitude data points to determine if the stored mean MPA magnitude data points exhibit a decreasing MPA magnitude trend signifying an improving heart failure state, an increasing MPA magnitude trend signifying a deteriorating heart failure state or a substantially unchanging MPA magnitude trend signifying a stable heart failure state.

10. The method of claim 1, wherein the step of determining the MPA characteristic further comprises:

determining the differences between the systolic peak blood pressures of two heart beats as MPA magnitudes; and

determining an average MPA magnitude data point from the determined MPA magnitudes.

11. The method of claim 10, wherein the assessing step further comprises comparing a series of stored average MPA magnitude data points to determine if the stored average MPA magnitude data points exhibit a decreasing MPA magnitude trend signifying an improving heart failure state, an increasing MPA magnitude trend signifying a deteriorating heart failure state or a substantially unchanging MPA magnitude trend signifying a stable heart failure state.

12. The method of claim 1, further comprising the step of detecting the end of an MPA episode of the patient'"'"'s heart from the blood pressure measurements, and wherein the step of determining the MPA characteristic comprises determining an MPA episode duration data point.

13. The method of claim 12, wherein the assessing step further comprises comparing a series of stored MPA duration data points to determine if the stored MPA duration data points exhibit a decreasing MPA duration trend signifying an improving heart failure state, an increasing MPA duration trend signifying a deteriorating heart failure state or a substantially unchanging MPA duration trend signifying a stable heart failure state.

14. The method of claim 1, wherein the step of determining the MPA characteristic further comprises:

determining the differences between the systolic peak blood pressures of two heart beats as MPA magnitudes; and

determining an MPA magnitude rate of change data point from the determined MPA magnitudes.

15. The method of claim 14, wherein the assessing step further comprises comparing a series of stored MPA rate of change data points to determine if the stored MPA rate of change data points exhibit a decreasing MPA rate of change trend signifying an improving heart failure state, an increasing MPA rate of change trend signifying a deteriorating heart failure state or a substantially unchanging MPA rate of change trend signifying a stable heart failure state.

16. A system for operating an implantable heart monitor implanted in a patient'"'"'s body having electrogram (EGM) sense electrodes coupled with EGM sense circuitry to generate sense events upon detection of cardiac depolarizations and a blood pressure measurement transducer disposed in a heart chamber and coupled with blood pressure measurement circuitry to assess heart failure state as a function of mechanical pulsus alternans (MPA) comprising:

means for operating the blood pressure measurement transducer to make blood pressure measurements;

means for detecting the onset of an MPA episode of the patient'"'"'s heart from the blood pressure measurements;

means for determining at least one MPA characteristic of the MPA episode suitable for assessing heart failure state.

17. The system of claim 16, wherein the means for determining the at least one MPA characteristic further comprises means for determining an MPA onset heart rate associated with the detection of onset of the MPA episode.

18. The system of claim 17, further comprising means for comparing a series of stored MPA onset heart rates to determine if the stored MPA onset heart rates exhibit an increasing heart rate trend signifying an improving heart failure state, a decreasing heart rate trend signifying a deteriorating heart failure state or a substantially unchanging heart rate trend signifying a stable heart failure state.

19. The system of claim 16, further comprising means for detecting the end of an MPA episode of the patient'"'"'s heart from the blood pressure measurements, and wherein the means for determining the at least one MPA characteristic further comprises means for determining an MPA end heart rate associated with the detection of the end of the MPA episode.

20. The system of claim 19, further comprising means for comparing a series of stored MPA end heart rates to determine if the stored MPA end heart rates exhibit an increasing heart rate trend signifying an improving heart failure state, a decreasing heart rate trend signifying a deteriorating heart failure state or a substantially unchanging heart rate trend signifying a stable heart failure state.

21. The system of claim 16, wherein the means for determining the MPA characteristic further comprises:

means for determining the differences between the systolic peak blood pressures of two heart beats as MPA magnitudes; and

means for determining a maximal MPA magnitude data point from the determined MPA magnitudes.

22. The system of claim 21, further comprising means for comparing a series of stored maximal MPA magnitude data points to determine if the stored maximal MPA magnitude data points exhibit a decreasing MPA magnitude trend signifying an improving heart failure state, an increasing MPA magnitude trend signifying a deteriorating heart failure state or a substantially unchanging MPA magnitude trend signifying a stable heart failure state.

23. The system of claim 16, wherein the means for determining the MPA characteristic further comprises:

means for determining the differences between the systolic peak blood pressures of two heart beats as MPA magnitudes; and

means for determining a mean MPA magnitude data point from the determined MPA magnitudes.

24. The system of claim 23, further comprising means for comparing a series of stored mean MPA magnitude data points to determine if the stored mean MPA magnitude data points exhibit a decreasing MPA magnitude trend signifying an improving heart failure state, an increasing MPA magnitude trend signifying a deteriorating heart failure state or a substantially unchanging MPA magnitude trend signifying a stable heart failure state.

25. The system of claim 16, wherein the means for determining the MPA characteristic further comprises:

means for determining the differences between the systolic peak blood pressures of two heart beats as MPA magnitudes; and

means for determining an average MPA magnitude data point from the determined MPA magnitudes.

26. The system of claim 25, further comprising means for comparing a series of stored average MPA magnitude data points to determine if the stored average MPA magnitude data points exhibit a decreasing MPA magnitude trend signifying an improving heart failure state, an increasing MPA magnitude trend signifying a deteriorating heart failure state or a substantially unchanging MPA magnitude trend signifying a stable heart failure state.

27. The system of claim 16, further comprising means for detecting the end of an MPA episode of the patient'"'"'s heart from the blood pressure measurements, and wherein the means for determining the MPA characteristic comprises means for determining an MPA episode duration data point.

28. The system of claim 16, further comprising means for comparing a series of stored MPA duration data points to determine if the stored MPA duration data points exhibit a decreasing MPA duration trend signifying an improving heart failure state, an increasing MPA duration trend signifying a deteriorating heart failure state or a substantially unchanging MPA duration trend signifying a stable heart failure state.

29. The system of claim 16, wherein the means for determining the MPA characteristic further comprises:

means for determining the differences between the systolic peak blood pressures of two heart beats as MPA magnitudes; and

means for determining an MPA magnitude rate of change data point from the determined MPA magnitudes.

30. The system of claim 29, further comprising means for comparing a series of stored MPA rate of change data points to determine if the stored MPA rate of change data points exhibit a decreasing MPA rate of change trend signifying an improving heart failure state, an increasing MPA rate of change trend signifying a deteriorating heart failure state, or a substantially unchanging MPA rate of change trend signifying a stable heart failure state.