Using multiple diagnostic parameters for predicting heart failure events

• US 10,299,693 B2
• Filed: 08/14/2017
• Issued: 05/28/2019
• 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.
• Primary Examiner(s): Alter, Alyssa M
• Application Number:
  US15/676,567
• Publication Number:
  US 20170360320A1
• Time in Patent Office: 652 Days
• 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

processing circuitry 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;

determine a plurality of values of an index over time based on the primary diagnostic parameter, wherein the index values are indicative of a degree of heart failure of the patient;

compare each of the determined values of the index to an upper threshold and a lower threshold, wherein the upper threshold and the lower threshold define a threshold zone;

in response to a first determined value of the index being outside of the threshold zone, determine whether to provide an alert to a user indicating worsening heart failure in the patient based on the determined value of the index and not based on the at least one secondary diagnostic parameter; and

in response to a second determined value of the index being within the threshold zone, determine whether to provide the alert to the user indicating worsening heart failure based on the at least one secondary diagnostic parameter.

2. The system of claim 1, wherein the processing circuitry is configured to provide the alert in response to the first determined value of the index being greater than the upper threshold.

3. The system of claim 1, wherein the processing circuitry is configured to withhold the alert in response to the first determined value of the index being less than the lower threshold.

4. The system of claim 1, wherein the processing circuitry is configured to:

monitor a plurality of secondary diagnostic parameters, the plurality of secondary diagnostic parameters including the at least one secondary diagnostic parameter; and

provide the alert indicating worsening heart failure when the index value is inside the threshold zone and a predetermined number of the secondary diagnostic parameters indicates worsening heart failure.

5. The system of claim 1, wherein the at least one sensor comprises at least one of a plurality of electrodes configured to detect intrathoracic impedance as the at least one primary diagnostic parameter, or a pressure sensor configured to detect a cardiovascular pressure as the at least one primary diagnostic parameter.

6. The system 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 (VT), or ventricular rate during VT.

7. 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.

8. The system of claim 1, wherein 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.

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

10. 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.

11. The system of claim 1, wherein the processing circuitry is configured to automatically adjust the threshold zone as a function of time.

12. The system of claim 1, wherein the values of the index are indicative of fluid accumulation of the patient.

13. The system of claim 1, wherein the processing circuitry is configured to receive a signal indicative of input from a user via an external programmer, and 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.

14. The system of claim 1, wherein the processing circuitry is 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.

15. The system of claim 1, wherein the processing circuitry is configured to automatically adjust the threshold zone based on efficacy of the alert in indicating worsening heart failure.

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

17. A method comprising:

monitoring, by processing circuitry, at least one primary diagnostic parameter and at least one secondary diagnostic parameter of a patient based on at least one signal from at least one sensor;

determining, by the processing circuitry, a plurality of values of an index over time based on the primary diagnostic parameter, wherein the index values are indicative of a degree of heart failure of the patient;

comparing, by the processing circuitry, each of the determined values of the index to an upper threshold and a lower threshold, wherein the upper threshold and the lower threshold define a threshold zone;

in response to a first determined value of the index being outside of the threshold zone, determining, by the processing circuitry, whether to provide an alert to a user indicating worsening heart failure in the patient based on the determined value of the index and not based on the at least one secondary diagnostic parameter; and

in response to a second determined value of the index being within the threshold zone, determining, by the processing circuitry, whether to provide the alert to the user indicating worsening heart failure based on the at least one secondary diagnostic parameter.

18. The method of claim 17, wherein providing the alert comprises providing the alert in response to the first determined value of the index being greater than the upper threshold.

19. The method of claim 17, wherein providing the alert comprises withholding the alert in response to the first determined value of the index being less than the lower threshold.

20. The method of claim 17, wherein monitoring at least one secondary diagnostic parameter comprises monitoring a plurality of secondary diagnostic parameters, the plurality of secondary diagnostic parameters including the at least one secondary diagnostic parameters, and wherein providing the alert comprises providing the alert indicating worsening heart failure when the index value is inside the threshold zone and a predetermined number of the secondary diagnostic parameters indicates worsening heart failure.

21. The method of claim 17, wherein the at least one sensor comprises at least one of a plurality of electrodes for detecting intrathoracic impedance as the at least one primary diagnostic parameter, or a pressure sensor for detecting a cardiovascular pressure as the at least one primary diagnostic parameter.

22. The method of claim 17, wherein the values of the index are indicative of fluid accumulation of the patient.

23. The method of claim 17, further comprising automatically adjusting, by the processing circuitry, 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.

24. The method of claim 17, further comprising automatically adjusting, by the processing circuitry, the threshold zone based on efficacy of the alert in indicating worsening heart failure.

25. The method of claim 17, wherein a subcutaneously implantable device comprises the at least one sensor.

26. A non-transitory computer readable storage medium comprising instructions that, when executed by processing circuitry, cause the processing circuitry 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 at least one sensor;

determine a plurality of values of an index over time based on the primary diagnostic parameter, wherein the index values are indicative of a degree of heart failure of the patient;

compare each of the determined values of the index to an upper threshold and a lower threshold, wherein the upper threshold and the lower threshold define a threshold zone;

in response to a first determined value of the index being outside of the threshold zone, determine whether to provide an alert to a user indicating worsening heart failure in the patient based on the determined value of the index and not based on the at least one secondary diagnostic parameter; and

in response to a second determined value of the index being within the threshold zone, determine whether to provide the alert to the user indicating worsening heart failure based on the at least one secondary diagnostic parameter.