Using multiple diagnostic parameters for predicting heart failure events

• US 9,730,601 B2
• Filed: 02/23/2015
• Issued: 08/15/2017
• Est. Priority Date: 07/31/2008
• Status: Active Grant

• Current Assignee: Medtronic Incorporated (Medtronic Plc)
• Original Assignee: Medtronic Incorporated (Medtronic Plc)
• Inventors: Hettrick, Douglas A, Sarkar, Shantanu, Stadler, Robert W
• Primary Examiner(s): Alter, Alyssa M
• Application Number:
  US14/629,027
• Publication Number:
  US 20150230722A1
• Time in Patent Office: 904 Days
• Field of Search: 607 18, 600301, 604 66
• 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 system comprising:

at least one sensor; and

one or more processors configured to;

monitor 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;

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

detect worsening heart failure in the patient when the index value is greater than an upper threshold of a threshold zone, the upper threshold and a lower threshold defining the threshold zone;

determine whether worsening heart failure is detected in the patient based on the secondary diagnostic parameter when the index value is within the threshold zone; and

adjust the threshold zone.

2. The system of claim 1, wherein the one or more processors are configured to:

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

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

3. The system of claim 1, wherein the one or more processors are configured to:

monitor a plurality of secondary diagnostic parameters, and

determine whether worsening heart failure is detected in the patient when the index value is inside the threshold zone and any of the secondary diagnostic parameters indicates worsening heart failure.

4. The system of claim 1, wherein the at least one sensor comprises one of a plurality of electrodes for detecting intrathoracic impedance as the primary diagnostic parameter or a pressure sensor for detecting a cardiovascular pressure as the primary diagnostic parameter.

5. The system of claim 1, 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.

6. The system of claim 1, wherein the at least one sensor comprises an accelerometer, and the at least one secondary diagnostic parameter comprises activity level.

7. The system of claim 1, 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.

8. The system of claim 1, 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.

9. The system of claim 1, 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.

10. The system of claim 1, further comprising an implantable medical device that houses the one or more processors, wherein the at least one sensor comprises at least one electrode located on an implantable medical lead coupled to the implantable medical device.

11. The system of claim 1, further comprising an implantable medical device, wherein the at least one sensor is at least one of within or coupled to the implantable medical device, and the implantable medical device comprises the one or more processors.

12. The system of claim 11, further comprising an external device that wirelessly communicates with the implantable medical device, wherein the one or more processors are configured to monitor the at least one secondary parameter based on information input by a user via the external device.

13. The system of claim 1, wherein the one or more processors automatically adjust the threshold zone as a function of time.

14. The system of claim 1, wherein the one or more processors provide an alert to a user in response to detecting worsening heart failure in the patient.

15. The system of claim 1, further comprising an implantable medical device that delivers a therapy to the patient, wherein the one or more processors automatically modify the therapy in response to detecting worsening heart failure in the patient.

16. The system of claim 15, 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.

17. The system of claim 1, wherein the index value is indicative of fluid accumulation of the patient.

18. The system of claim 1, wherein the one or more processors automatically adjust the threshold zone by one of increasing or decreasing at least one of the lower threshold or the upper threshold.

19. The system of claim 1, wherein:

the one or more processors are configured to receive a signal indicative of input from a user via an external programmer,

the input requests adjustment of the threshold zone based on one or more symptoms of the patient, and

the one or more processors are configured to adjust, based on the signal indicative of the input, at least one of the lower threshold or the upper threshold that defines the threshold zone.

20. The system of claim 1, wherein the one or more processors are configured to automatically adjust the threshold zone based on one or more monitored diagnostic parameters indicative of patient condition, wherein the one or more monitored diagnostic parameters comprise at least one of the at least one primary diagnostic parameter or the at least one secondary diagnostic parameter.

21. The system of claim 1, wherein the one or more processors are configured to automatically adjust the threshold zone based on efficacy of identifying worsening heart failure.

22. The system of claim 1, wherein the one or more processors are configured to:

determine that the index value is below the lower threshold; and

responsive to determining that the index value is below the lower threshold, adjust the threshold zone.

23. The system of claim 1, further comprising a subcutaneously implantable device that comprises the at least one sensor.

24. A computer-readable medium comprising instructions that cause one or more processors to:

monitor at least one primary diagnostic parameter and at least one secondary diagnostic parameter of a patient;

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

detect worsening heart failure in the patient when the index value is greater than an upper threshold of a threshold zone, the upper threshold and a lower threshold defining the threshold zone;

determine whether worsening heart failure is detected in the patient based on the secondary diagnostic parameter when the index value is within the threshold zone; and

adjust the threshold zone.

25. A system comprising:

means for monitoring at least one primary diagnostic parameter and at least one secondary diagnostic parameter of a patient;

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

means for detecting worsening heart failure in the patient when the index value is greater than an upper threshold of a threshold zone, the upper threshold and a lower threshold defining the threshold zone;

means for determining whether worsening heart failure is detected in the patient based on the secondary diagnostic parameter when the index value is within the threshold zone; and

means for adjusting the threshold zone.

26. An implantable medical device comprising:

at least one sensor; and

one or more processors configured to;

monitor 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;

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

detect worsening heart failure in the patient when the index value is greater than an upper threshold of a threshold zone, the upper threshold and a lower threshold defining the threshold zone; and

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