Cardiac rhythm management systems and methods predicting congestive heart failure status

• US 7,127,290 B2
• Filed: 08/06/2002
• Issued: 10/24/2006
• Est. Priority Date: 10/01/1999
• Status: Expired due to Term

• Current Assignee: Cardiac Pacemakers Incorporated (Boston Scientific Corporation)
• Original Assignee: Cardiac Pacemakers Incorporated (Boston Scientific Corporation)
• Inventors: Stahmann, Jeffrey E., Sweeney, Robert J., Girouard, Steven D., KenKnight, Bruce H.
• Primary Examiner(s): Sykes, Angela D.
• Assistant Examiner(s): Faulcon, Jr., Lenwood
• Application Number:
  US10/213,268
• Publication Number:
  US 20030055461A1
• Time in Patent Office: 1,540 Days
• Field of Search: 600/515, 607/17
• US Class Current: 607/17
• CPC Class Codes: A61B 5/4842 Monitoring progression or stage of a disease
• CPC Class Codes: A61N 1/3627 for treating a mechanical deficiency of the heart, e.g. congestive heart failure or cardiomyopathy

Abstract

This document describes, among other things, systems, devices, and methods for predicting how the status of the patient'"'"'s congestive heart failure (CHF) condition will progress in the future. In one example, a therapy is provided or adjusted at least in part in response to the prediction.

Claims

1. A cardiac rhythm management system comprising:

an implantable cardiac rhythm management device comprising;

at least one congestive heart failure (CHF) physiologic parameter input device to provide CHF physiologic information about a subject, the CHF physiologic information comprising information about at least one of the subject'"'"'s dyspnea, orthopnea, neck vein distension, abdominojugular reflex, cough, hepatomegaly, peripheral edema, brain patriaretic peptide (BNP) level, or at least one of pulmonary edema, cardiomegaly, or pleural effusion wherein the input device comprises an implantable transthoracic impedance sensor configured to provide information about the subject'"'"'s pulmonary edema, cardiomegaly, or pleural effusion; and

a processor circuit, comprising at least one processor input coupled to the at least one CHF physiologic parameter input device to receive a plurality of different CHF physiologic parameters, the processor comprising;

weighting factors, stored in a memory, the weighting factors corresponding to each of the received CHF physiologic parameters; and

a CHF status change probability indicator, to predict a likelihood of a subsequent change in a CHF status of a subject using the plurality of different received CHF physiologic parameters and corresponding weighting factors; and

an external remote user interface communicatively couplable to the implantable cardiac rhythm management device, the external remote user interface comprising a user-detectable indication of the CHF status change probability indicator received from the implantable cardiac rhythm management device, in which the remote user interface comprises a user input device to receive at least one CHF physiologic parameter from a user and to communicate to the at least one CHF physiological parameter input device in the implantable cardiac rhythm management device the at least one CHF physiological parameter selected from the group consisting of at least one or more of the subject'"'"'s dyspnea, orthopnea, neck vein distension, abdominojugular reflex, cough, hepatomegaly, peripheral edema, brain natriaretic peptide (BNP) level, pulmonary edema, cardiomegaly, or pleural effusion.

2. The system of claim 1, in which a first weighting parameter corresponding to a first received CHF physiologic parameter, used to predict the likelihood of a subsequent change in the CHF status of the subject, depends on which at least one other received CHF physiologic parameter is also used to predict the likelihood of a subsequent change in CHF status.

3. The system of claim 1, in which a first weighting parameter corresponding to a first received CHF physiologic parameter, used to predict the likelihood of a subsequent change in the CHF status of the subject, depends on the number of other received CHF physiologic parameters that are also used to predict the likelihood of a subsequent change in CHF status.

4. The system of claim 1, in which the CHF status change probability indicator, is configured to predict a likelihood of a subsequent change in a CHF status of a subject by comparing to a threshold value a probability computed using the plurality of different received CHF physiologic parameters and corresponding weighting factors.

5. The system of claim 1, in which at least one of the weighting factors is computed using historical data relating its corresponding CHF physiologic parameter to CHF status.

6. The system of claim 5, in which the historical data is obtained from the same subject from which the CHF physiologic information is obtained.

7. The system of claim 5, in which the historical data is obtained from at least one subject other than the subject from which the CHF physiologic information is obtained.

8. The system of claim 1, further comprising a therapy control module configured to adjust a therapy provided to the subject using at least the CHF status change probability indicator.

9. The system of claim 1, in which the user interface is configured to receive from the user at least one CHF physiologic parameter further comprising information about the subject'"'"'s weight to communicate to the at least one CHF physiologic parameter input device in the implantable cardiac rhythm management device.

10. The system of claim 9, in which the user interface is configured to receive from the user at least one CHF physiologic parameter comprising information about the subject'"'"'s dyspnea to communicate to the at least one CHF physiologic parameter input device in the implantable cardiac rhythm management device.

11. The system of claim 9, in which the user interface is configured to receive from the user at least one CHF physiologic parameter comprising information about the subject'"'"'s orthopnea to communicate to the at least one CHF physiologic parameter input device in the implantable cardiac rhythm management device.

12. The system of claim 9, in which the user interface is configured to receive from the user at least one CHF physiologic parameter comprising information about the subject'"'"'s neck vein distention to communicate to the at least one CHF physiologic parameter input device in the implantable cardiac rhythm management device.

13. The system of claim 9, in which the user interface is configured to receive from the user at least one CHF physiologic parameter comprising information about the subject'"'"'s abdominojugular reflex to communicate to the at least one CHF physiologic parameter input device in the implantable cardiac rhythm management device.

14. The system of claim 9, in which the user interface is configured to receive from the user at least one CHF physiologic parameter comprising information about the subject'"'"'s cough to communicate to the at least one CHF physiologic parameter input device in the implantable cardiac rhythm management device.

15. The system of claim 9, in which the user interface is configured to receive from the user at least one CHF physiologic parameter comprising information about the subject'"'"'s hepatomegaly to communicate to the at least one CHF physiologic parameter input device in the implantable cardiac rhythm management device.

16. The system of claim 9, in which the user interface is configured to receive from the user at least one CHF physiologic parameter comprising information about the subject'"'"'s peripheral edema to communicate to the at least one CHF physiologic parameter input device in the implantable cardiac rhythm management device.

17. The system of claim 9, in which the user interface is configured to receive from the user at least one CHF physiologic parameter comprising information about the subject'"'"'s brain natriaretic peptide (BNP) level.

18. The system of claim 1, in which the at least one congestive heart failure (CHF) physiologic parameter input device of the implantable cardiac rhythm management device comprises an implantable transthoracic impedance sensor configured to provide information about the subject'"'"'s pulmonary edema.

19. The system of claim 1, in which the at least one congestive heart failure (CHF) physiologic parameter input device of the implantable cardiac rhythm management device comprises an implantable transthoracic impedance sensor configured to provide information about the subject'"'"'s cardiomegaly.

20. The system of claim 1, in which the at least one congestive heart failure (CHF) physiologic parameter input device of the implantable cardiac rhythm management device comprises an implantable transthoracic impedance sensor configured to provide information about the subject'"'"'s pleural effusion.

21. The system of claim 1, in which the at least one congestive heart failure (CHF) physiologic parameter input device of the implantable cardiac rhythm management device comprises implantable respiration and posture sensors configured to provide information about the subject'"'"'s dyspnea.

22. The system of claim 1, in which the at least one congestive heart failure (CHF) physiologic parameter input device of the implantable cardiac rhythm management device comprises an implantable sound sensor configured to provide information about the subject'"'"'s respiration sounds.

23. The system of claim 1, in which the at least one congestive heart failure (CHF) physiologic parameter input device of the implantable cardiac rhythm management device comprises an implantable sound sensor configured to provide information about the subject'"'"'s heart contraction sounds.

24. The system of claim 1, in which the at least one congestive heart failure (CHF) physiologic parameter input device of the implantable cardiac rhythm management device comprises an implantable pressure sensor configured to provide information about the subject'"'"'s intravascular pressure.

25. The system of claim 1, in which the at least one congestive heart failure (CHF) physiologic parameter input device of the implantable cardiac rhythm management device comprises pressure sensor sized and shaped to be placed in at least one of a left ventricle and a left atrium for providing an intracardiac pressure measurement, the intracardiac pressure measurement comprising at least one of a left ventricular end diastolic pressure (LVEDP) measurement and a left atrial (LA) pressure measurement.

26. The system of claim 1, further comprising an external scale communicatively couplable to the implantable cardiac rhythm management device, the scale configured to communicate information about the subject'"'"'s weight to the at least one congestive heart failure (CHF) physiologic parameter input device of the implantable cardiac rhythm management device.

27. A cardiac rhythm management system comprising:

an implantable cardiac rhythm management device comprising;

means for providing at least one congestive heart failure (CHF) physiologic parameter about a subject, the CHF physiologic information comprising information about at least one of the subject'"'"'s dyspnea, orthopnea, neck vein distension, abdominojugular reflex, cough, hepatomegaly, peripheral edema, brain natriaretic peptide (BNP) level, pulmonary edema, cardiomegaly, or pleural effusion; and

a processor circuit, comprising at least one processor input coupled to the at least one CHF physiologic parameter input device to receive a plurality of different CHF physiologic parameters, the processor comprising;

weighting factors, stored in a memory, the weighting factors corresponding to each of the received CHF physiologic parameters; and

a CHF status change probability indicator, to predict a likelihood of a subsequent change in a CHF status of a subject using a probability computed using the plurality of different received CHF physiologic parameters and corresponding weighting factors; and

an external remote user interface communicatively couplable to the implantable cardiac rhythm management device, the external remote user interface comprising a user-detectable indication of the CHF status change probability indicator received from the implantable cardiac rhythm management device, in which the remote user interface comprises a user input device to receive at least one CHF physiologic parameter from a user and to communicate to the at least one CHF physiological parameter input device in the implantable cardiac rhythm management device the at least one CHF physiological parameter selected from the group consisting of at least one or more of the subject'"'"'s dyspnea, orthopnea, neck vein distension, abdominojugular reflex, cough, hepatomegaly, peripheral edema, brain natriaretic peptide (BNP) level, pulmonary edema, cardiomegaly, or pleural effusion.

28. A cardiac rhythm management system comprising:

an implantable cardiac rhythm management device comprising;

at least one congestive heart failure (CHF) conditioning event input device to provide a CHF conditioning event statistically associated with the occurrence of a CHF status change in a subject;

a processor circuit, comprising at least one processor input coupled to the at least one CHF conditioning event input device to receive the CHF conditioning event, the processor comprising an indicator predicting the occurrence of a CHF status change within a specified prediction time period if an estimated CHF status change probability exceeds a specified threshold value, wherein the estimated CHF status change probability is computed from a conditional CHF status change probability, associated with the conditioning event, that is derived from past observations of instances in which the conditioning event occurs alone or together with a CHF status change within a specified time period; and

wherein the processor is adapted to estimate a rate C at which the conditioning event occurs, and further wherein the estimated CHF status change probability is calculated by the expression;

estimated CHF status change probability=CP×

(1−

e<sup>−

CT</sup>).

29. The system of claim 28, in which the conditional CHF status change probability is a ratio of the number of observed instances in which the conditioning event is followed by a CHF status change within a specified basic time period to the total number of observed instances of the conditioning event.

30. The system of claim 28, wherein the conditional CHF status change probability is calculated by the expression:

CP=1−

e<sup>−

RT</sup>,

wherein T is a measure of the specified prediction time period, and R is an estimate of the rate at which CHF status changes occur while the conditioning event is present.

31. A method comprising:

obtaining a plurality of different congestive heart failure (CHF) physiologic parameters about a subject for predicting a CHF status change, in which the obtaining the plurality of different CHF physiologic parameters about the subject comprises at least one of;

receiving a user input information about at least one of the subject'"'"'s dyspnea, orthopnea, neck vein distention, abdominojugular reflex, cough, hepatomegaly, peripheral edema, and brain natiaretic peptide (BNP) level; and

sensing a thoracic impedance to obtain information about at least one of the subject'"'"'s pulmonary edema, cardiomegaly, and pleural effusion;

weighting each of the CHF physiologic parameters to provide corresponding weighted CHF physiologic parameters;

computing a CHF status change probability using the weighted CHF physiologic parameters; and

using the computed CHF status change probability in predicting whether the subject'"'"'s CHF status will undergo a significant change within a specified subsequent time period.

32. The system of claim 31, in which the weighting each of the CHF physiologic parameters comprises weighting a first CHF physiologic parameter depending at least in part on which other CHF physiologic parameters are obtained from the patient for predicting the CHF status change.

33. The system of claim 31, in which the weighting each of the CHF physiologic parameters comprises weighting a first CHF physiologic parameter depending at least in part on how many other CHF physiologic parameters are obtained from the patient for predicting the CHF status change.

34. The method of claim 31, in which the predicting whether the subject'"'"'s CHF status will undergo a significant change within a specified time period comprises comparing the computed CHF status change probability to a threshold.

35. The method of claim 31, further comprising adjusting a therapy provided by an implantable cardiac rhythm management device to the subject using at least the computed CHF status change probability.

36. The method of claim 31, in which the weighting comprises weighting at least one of the CHF physiologic parameters using historical data obtained from the subject.

37. The method of claim 31, in which the weighting comprises weighting at least one of the CHF physiologic parameters using historical data obtained from a different subject.

38. The method of claim 31, in which the obtaining the plurality of different CHF physiologic parameters about the subject comprises receiving a user input including information about the subject'"'"'s weight.

39. The method of claim 31, in which the obtaining the plurality of different CHF physiologic parameters about the subject comprises receiving a user input including information about the subject'"'"'s dyspnea.

40. The method of claim 31, in which the obtaining the plurality of different CHF physiologic parameters about the subject comprises receiving a user input including information about the subject'"'"'s orthopnea.

41. The method of claim 31, in which the obtaining the plurality of different CHF physiologic parameters about the subject comprises receiving a user input including information about the subject'"'"'s neck vein distention.

42. The method of claim 31, in which the obtaining the plurality of different CHF physiologic parameters about the subject comprises receiving a user input including information about the subject'"'"'s abdominojugular reflex.

43. The method of claim 31, in which the obtaining the plurality of different CHF physiologic parameters about the subject comprises receiving a user input including information about the subject'"'"'s cough.

44. The method of claim 31, in which the obtaining the plurality of different CHF physiologic parameters about the subject comprises receiving a user input including information about the subject'"'"'s hepatomegaly.

45. The method of claim 31, in which the obtaining the plurality of different CHF physiologic parameters about the subject comprises receiving a user input including information about the subject'"'"'s peripheral edema.

46. The method of claim 31, in which the obtaining the plurality of different CHF physiologic parameters about the subject comprises receiving a user input including information about the subject'"'"'s brain natiaretic peptide (BNP) level.

47. The method of claim 31, in which the obtaining the plurality of different CHF physiologic parameters about the subject comprises sensing a transthoracic impedance to obtain information about the subject'"'"'s pulmonary edema.

48. The method of claim 31, in which the obtaining the plurality of different CHF physiologic parameters about the subject comprises sensing a transthoracic impedance to obtain information about the subject'"'"'s cardiomegaly.

49. The method of claim 31, in which the obtaining the plurality of different CHF physiologic parameters about the subject comprises sensing a transthoracic impedance to obtain information about the subject'"'"'s pleural effusion.

50. The method of claim 31, in which the obtaining the plurality of different CHF physiologic parameters about the subject comprises sensing respiration and posture to obtain information about the subject'"'"'s dyspnea.

51. The method of claim 31, in which the obtaining the plurality of different CHF physiologic parameters about the subject comprises sensing the subject'"'"'s respiration sounds.

52. The method of claim 31, in which the obtaining the plurality of different CHF physiologic parameters about the subject comprises sensing the subject'"'"'s heart contraction sounds.

53. The method of claim 31, in which the obtaining the plurality of different CHF physiologic parameters about the subject comprises sensing the subject'"'"'s intravascular pressure.

54. The method of claim 31, in which the obtaining the plurality of different CHF physiologic parameters about the subject comprises sensing the subject'"'"'s intracardiac pressure selected from the group consisting of a left ventricular end-diastolic pressure (LVEDP) and a left atrial (LA) pressure.

55. The method of claim 31, in which the obtaining the plurality of different CHF physiologic parameters about the subject comprises measuring the subject'"'"'s weight at an external scale and telemetering the subject'"'"'s weight from the external scale to an implantable cardiac rhythm management device.