USING MULTIPLE DIAGNOSTIC PARAMETERS FOR PREDICTING HEART FAILURE EVENTS

• US 20100030293A1
• Filed: 07/31/2008
• Published: 02/04/2010
• Est. Priority Date: 07/31/2008
• Status: Active Grant

• Current Assignee: Medtronic Incorporated (Medtronic Plc)
• Original Assignee: Medtronic Incorporated (Medtronic Plc)
• Inventors: Sarkar, Shantanu, Hettrick, Douglas A., Stadler, Robert W.
• Granted Patent: US 9,713,701 B2
• Time in Patent Office: Days
• US Class Current: 607/18
• CPC Class Codes: A61B 2562/0219 Inertial sensors, e.g. accelerometers, gyroscopes, tilt switches
• CPC Class Codes: A61B 5/0205 Simultaneously evaluating both cardiovascular conditions and different types of body conditions, e.g. heart and respiratory condition
• CPC Class Codes: A61B 5/021 Measuring pressure in heart or blood vessels A61B5/0205 takes precedence
• CPC Class Codes: A61B 5/0537 Measuring body composition by impedance, e.g. tissue hydration or fat content
• CPC Class Codes: A61B 5/0538 invasively, e.g. using a catheter
• CPC Class Codes: A61B 5/08 Detecting, measuring or recording devices for evaluating the respiratory organs A61B5/0205 takes precedence
• CPC Class Codes: A61B 5/1118 Determining activity level
• CPC Class Codes: A61B 5/287 Holders for multiple electrodes, e.g. electrode catheters for electrophysiological study [EPS]
• CPC Class Codes: A61B 5/361 Detecting fibrillation
• CPC Class Codes: A61B 5/363 Detecting tachycardia or bradycardia
• CPC Class Codes: A61B 5/7275 Determining trends in physiological measurement data; Predicting development of a medical condition based on physiological measurements, e.g. determining a risk factor
• CPC Class Codes: A61M 2230/04 Heartbeat characteristics, e.g. ECG, blood pressure modulation
• CPC Class Codes: A61M 2230/42 Rate
• CPC Class Codes: A61M 37/00 Other apparatus for introducing media into the body for reproduction or fertilisation A61B17/425; apparatus for iontophoresis or cataphoresis A61N1/30; Percutany, i.e. introducing medicines into the body by diffusion through the skin salt baths A61H33/04
• CPC Class Codes: A61M 5/1723 using feedback of body parameters, e.g. blood-sugar, pressure measurement of body parameters A61B5/00
• CPC Class Codes: A61N 1/36585 controlled by two or more physical parameters

Abstract

Techniques for using multiple physiological parameters to provide an early warning for worsening heart failure are described. A medical device monitors a primary diagnostic parameter that is indicative of worsening heart failure, such as intrathoracic impedance or pressure, and one or more secondary diagnostic parameters. The medical device detects worsening heart failure in the patient based on the primary diagnostic parameter when an index that is changed over time based on the primary diagnostic parameter value is outside a range of values, termed the threshold zone. When the index is within the threshold zone, the medical device detects worsening heart failure in the patient based on the one or more secondary diagnostic parameters. Upon detecting worsening heart failure, the medical device may, for example, provide an alert that enables the patient to seek medical attention before experiencing a heart failure event.

Claims

1. A method comprising:

monitoring at least one primary diagnostic parameter and at least one secondary diagnostic parameter of a patient, wherein the primary and secondary diagnostic parameters are associated with worsening heart failure;

changing an index value over time based on the first diagnostic parameter, wherein the index indicates worsening heart failure of the patient;

determining whether worsening heart failure is detected in the patient based on the fluid index when the index is outside of a threshold zone defined by a lower threshold and an upper threshold; and

determining whether worsening heart failure is detected in the patient based on the secondary diagnostic parameter when the index is inside the threshold zone.

2. The method of claim 1, wherein determining whether worsening heart failure is detected in the patient based on the index when the index is outside a threshold zone comprises:

determining that worsening heart failure is detected in the patient when the index is greater than the upper threshold value; and

determining that worsening heart failure is not detected in the patient when the index is less than the lower threshold value.

3. The method of claim 1,

wherein monitoring at least one secondary diagnostic parameter comprises monitoring a plurality of secondary diagnostic parameters, and

wherein determining whether worsening heart failure is detected in the patient based on the secondary diagnostic parameter comprises determining whether worsening heart failure is detected in the patient when any of the secondary diagnostic parameters indicates worsening heart failure.

4. The method of claim 1, wherein the primary diagnostic parameter comprises intrathoracic impedance.

5. The method of claim 1, wherein the primary diagnostic parameter comprises cardiovascular pressure.

6. The method of claim 1, wherein the at least one secondary diagnostic parameter comprises one or more of atrial fibrillation (AF) burden, ventricular rate during AF, ventricular fibrillation (VF) burden, ventricular rate during VF, atrial tachyarrhythmia (AT) burden, ventricular rate during AT, ventricular tachyarrhythmia burden (VT), or ventricular rate during VT.

7. The method of claim 1, wherein the at least one secondary diagnostic parameter comprises one or more of activity level, heart rate variability, percentage of cardiac resynchronization pacing, night heart rate, difference between day heart rate and night heart rate, heart rate turbulence, heart rate deceleration capacity, or baroreflex sensitivity.

8. The method of claim 1, wherein the at least one secondary diagnostic parameter comprises one or more of respiratory rate, respiratory depth, or respiratory pattern.

9. The method of claim 1, wherein the at least one secondary diagnostic parameter comprises one or more of weight, blood pressure, metrics of renal function, medication history, or history of heart failure hospitalization.

10. The method of claim 1, wherein the threshold zone is static over time.

11. The method of claim 1, further comprising changing the threshold zone over time.

12. The method of claim 11, wherein changing the threshold zone over time comprises at least one of automatically changing a size of the threshold zone, or automatically changing a range of the threshold zone.

13. The method of claim 11, wherein dynamically changing the threshold zone comprises automatically changing the threshold zone as a function of time.

14. The method of claim 1,

wherein determining whether worsening heart failure is detected in the patient based on the secondary diagnostic parameter comprises comparing the secondary diagnostic parameter to a first threshold and a second threshold,

wherein the first threshold is a predetermined constant threshold, the second threshold is variable, and comparison of the secondary diagnostic parameter to the second threshold indicates a rate of change of the secondary diagnostic parameter.

15. The method of claim 1, further comprising generating an alert in response to detecting worsening heart failure in the patient.

16. The method of claim 1, further comprising automatically modifying a therapy delivered to the patient in response to detecting worsening heart failure in the patient.

17. The method of claim 16, wherein the therapy comprises at least one of a substance delivered by an implantable pump, cardiac resynchronization therapy, refractory period stimulation, or cardiac potentiation therapy.

18. The method of claim 1, wherein the index comprises a fluid index that indicates fluid accumulation of the patient.

19. The method of claim 1, wherein monitoring at least one secondary diagnostic parameter of the patient comprises monitoring the at least one secondary diagnostic parameter when the index is greater than a secondary diagnostic parameter monitoring threshold that is less than the lower threshold.

20. The method of claim 19, wherein monitoring at least one secondary diagnostic parameter of the patient comprises monitoring the at least one secondary diagnostic parameter when the index is within an threshold zone defined by the secondary diagnostic parameter monitoring threshold and the upper threshold.

21. A system comprising:

at least one sensor; and

a processor that;

monitors at least one primary diagnostic parameter and at least one secondary diagnostic parameter of a patient based on at least one signal from the at least one sensor, wherein the primary and secondary diagnostic parameters are associated with worsening heart failure of the patient,

changes an index value over time based on the primary diagnostic parameter, wherein the index indicates worsening heart failure of the patient,

determines whether worsening heart failure is detected in the patient based on the fluid index when the index is outside of a threshold zone defined by a lower threshold and an upper threshold, and

determines whether worsening heart failure is detected in the patient based on the secondary diagnostic parameter when the fluid index is inside the threshold zone.

22. The system of claim 21, wherein the processor:

determines that worsening heart failure is detected in the patient when the index is greater than the upper threshold value, and

determines that worsening heart failure is not detected in the patient when the index is less than the lower threshold value.

23. The system of claim 21, wherein the processor monitors a plurality of secondary diagnostic parameters, and determines whether worsening heart failure is detected in the patient when any of the secondary diagnostic parameters indicates worsening heart failure.

24. The system of claim 21, wherein the at least one sensor comprises a plurality of electrodes, and the primary diagnostic parameter comprises intrathoracic impedance.

25. The system of claim 21, wherein the at least one sensor comprises a pressure sensor, and the primary diagnostic parameter comprises cardiovascular pressure.

26. The system of claim 21, wherein the at least one sensor comprises a plurality of electrodes, and the at least one secondary diagnostic parameter comprises one or more of atrial fibrillation (AF) burden, ventricular rate during AF, ventricular fibrillation (VF) burden, ventricular rate during VF, atrial tachyarrhythmia (AT) burden, ventricular rate during AT, ventricular tachyarrhythmia (VT), or ventricular rate during VT.

27. The system of claim 21, wherein the at least one sensor comprises an accelerometer, and the at least one secondary diagnostic parameter comprises activity level.

28. The system of claim 21, wherein the at least one sensor comprises a plurality of electrodes, and the at least one secondary diagnostic parameter comprises one or more of heart rate variability, night heart rate, difference between day heart rate and night heart rate, heart rate turbulence, or heart rate deceleration capacity.

29. The system of claim 21, wherein the at least one sensor comprises a plurality of electrodes, and the at least one secondary diagnostic parameter comprises one or more of respiratory rate, respiratory depth, or respiratory pattern.

30. The system of claim 21, wherein the at least one secondary diagnostic parameter comprises one or more of percentage of cardiac resynchronization pacing, baroreflex sensitivity, weight, blood pressure, metrics of renal function, medication history, or history of heart failure hospitalization.

31. The system of claim 21, wherein the at least one sensor comprises at least one electrode located on an implantable medical lead coupled to an implantable medical device.

32. The system of claim 21, wherein the at least one sensor is at least one of within or coupled to an implantable medical device, and the processor comprises a processor of the implantable medical device.

33. The system of claim 32, further comprising an external device that wirelessly communicates with the implantable medical device, wherein the processor monitors the at least one secondary parameter based on information input by a user via the external device.

34. The system of claim 21, wherein the processor automatically changes the threshold zone as a function of time.

35. The system of claim 21,

wherein the processor compares the secondary diagnostic parameter to a first threshold and a second threshold,

wherein the first threshold is a predetermined constant threshold, the second threshold is variable, and comparison of the secondary diagnostic parameter to the second threshold indicates a rate of change of the secondary diagnostic parameter.

36. The system of claim 21, wherein the processor provides an alert to a user in response to detecting worsening heart failure in the patient.

37. The system of claim 21, further comprising an implantable medical device that delivers a therapy to the patient, wherein the processor automatically modifies the therapy in response to detecting worsening heart failure in the patient.

38. The system of claim 37, wherein the therapy comprises at least one of a substance delivered by an implantable pump, cardiac resynchronization therapy, refractory period stimulation, or cardiac potentiation therapy.

39. The system of claim 21, wherein the index comprises a fluid index that indicates fluid accumulation of the patient.

40. The system of claim 21, wherein the processor monitors the at least one secondary diagnostic parameter when the index is greater than a secondary diagnostic parameter monitoring threshold that is less than the lower threshold.

41. The system of claim 40, wherein the processor monitors the at least one secondary diagnostic parameter when the index is within a threshold zone defined by the secondary diagnostic parameter monitoring threshold and the upper threshold.

42. A computer-readable medium comprising instructions that cause a processor to:

monitor at least one primary diagnostic parameter and at least one secondary diagnostic parameter of a patient, wherein the primary and secondary diagnostic parameters are associated with worsening heart failure;

change an index value over time based on the primary diagnostic parameter, wherein the index indicates worsening heart failure of the patient;

determine whether worsening heart failure is detected in the patient based on the index when the index is outside of a threshold zone defined by a lower threshold and an upper threshold; and

determine whether worsening heart failure is detected in the patient based on the secondary diagnostic parameter when the index is inside the threshold zone.

43. A system comprising:

means for monitoring at least one primary diagnostic parameter and at least one secondary diagnostic parameter of a patient, wherein the primary and secondary diagnostic parameters are associated with worsening heart failure;

means for changing an index value over time based on the primary diagnostic parameter, wherein the index indicates worsening heart failure of the patient;

means for determining whether worsening heart failure is detected in the patient based on the index when the index is outside of a threshold zone defined by a lower threshold and an upper threshold; and

means for determining whether worsening heart failure is detected in the patient based on the secondary diagnostic parameter when the index is inside the threshold zone.