System and method for evaluating heart failure using an implantable medical device based on heart rate during patient activity

• US 20050256545A1
• Filed: 05/11/2004
• Published: 11/17/2005
• Est. Priority Date: 05/11/2004
• Status: Active Grant

• Current Assignee: Pacesetter Incorporated (Abbott Laboratories Incorporated)
• Original Assignee: Pacesetter Incorporated (Abbott Laboratories Incorporated)
• Inventors: Koh, Steve, Park, Euljoon
• Granted Patent: US 7,171,271 B2
• Time in Patent Office: Days
• US Class Current: 607/17
• CPC Class Codes: A61B 2562/0219 Inertial sensors, e.g. accelerometers, gyroscopes, tilt switches
• CPC Class Codes: A61B 5/0006 ECG or EEG signals
• CPC Class Codes: A61B 5/0031 Implanted circuitry
• CPC Class Codes: A61B 5/0245 by using sensing means generating electric signals, i.e. ECG signals
• CPC Class Codes: A61B 5/0816 Measuring devices for examining respiratory frequency measuring frequency of electric signals G01R23/00
• CPC Class Codes: A61B 5/1118 Determining activity level
• CPC Class Codes: A61B 5/145 Measuring characteristics of blood in vivo, e.g. gas concentration, pH value; Measuring characteristics of body fluids or tissues, e.g. interstitial fluid, cerebral tissuemeasuring of blood pressure or blood flow A61B5/02; non-radiation detecting or locating of foreign bodies in blood A61B5/06
• CPC Class Codes: A61B 5/222 combined with detection or measurement of physiological parameters, e.g. heart rate
• CPC Class Codes: A61B 5/287 Holders for multiple electrodes, e.g. electrode catheters for electrophysiological study [EPS]
• 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: A61N 1/3627 for treating a mechanical deficiency of the heart, e.g. congestive heart failure or cardiomyopathy
• CPC Class Codes: A61N 1/36542 controlled by body motion, e.g. acceleration

Abstract

Techniques are provided for detecting and tracking heart failure based on heart rate, rest rate and activity levels. Briefly, histograms are generated based on rest-rate adjusted heart rate values and corresponding activity level values. Heart failure is then detected and tracked based on an analysis of the histogram. In one example, so long as the activity level of the patient exceeds some minimum threshold, the ratio of adjusted heart rate to activity level is periodically calculated and resulting values are stored in a histogram. Each day, the histogram is compared against a previous histogram to detect any overall trend. For example, the centroid of the histogram can be calculated each day with any changes in the centroid values used to track progression of heart failure.

Claims

1. A method for evaluating heart failure within a patient using an implantable medical device, the method comprising:

detecting values representative of patient heart rate and corresponding activity levels for the patient during a period of time when the patient is active;

deriving cardiac fitness values based on heart rate and corresponding activity levels detected during the period of time when the patient is active and based on a predetermined rest heart rate of the patient; and

evaluating heart failure, if any, within the patient based on the cardiac fitness values.

2. The method of claim 1 wherein detecting values representative of heart rate and corresponding activity levels comprises determining whether the patient is active by comparing patient activity levels against an activity threshold representative of a minimum level of activity.

3. The method of claim 1 wherein detecting values representative of heart rate and corresponding activity levels comprises detecting activity levels using an implanted activity sensor.

4. The method of claim 1 wherein deriving the cardiac fitness values is performed by calculating individual ratios of rest-rate adjusted heart rates to corresponding activity levels.

5. The method of claim 4 wherein deriving cardiac fitness values is performed by calculating a ratio R for each of a pair of heart rate values and corresponding activity level vales where:

R=(Heart Rate−

Rest Rate)/Activity Level.

6. The method of claim 4 wherein deriving a cardiac fitness value is performed by inputting a value representative of a maximum heart rate for the patient and then calculating a ratio R for each of a pair of heart rate values and corresponding activity level vales where:

R=(Heart Rate−

Rest Rate)/(Heart Rate Reserve)/Activity Level

where Heart Rate Reserve is Maximum Heart Rate minus Rest Rate.

7. The method of claim 4 wherein evaluating heart failure, if any, within the patient is performed based on a plurality of cardiac fitness values derived from a plurality of detected heart rate values and corresponding active level values obtained during a plurality of periods of time while the patient is active.

8. The method of claim 7 wherein evaluating heart failure within the patient comprises:

generating a histogram (H) based on the plurality of cardiac fitness values;

deriving a numerical measure (M) of the histogram representative of a specified characteristic of the histogram; and

evaluating heart failure based on the value of M.

9. The method of claim 8 wherein the numerical measure (M) of the histogram is representative of one or more of a centroid, mean, median or average of the histogram.

10. The method of claim 9 wherein evaluating heart failure within the patient comprises detecting the presence of heart failure by comparing M against a threshold indicative of heart failure.

11. The method of claim 9 wherein evaluating heart failure within the patient comprises determining the severity of heart failure by comparing M against a set of threshold values indicative of different levels of severity of hart failure.

12. The method of claim 8 wherein evaluating heart failure within the patient comprises tracking changes in the severity of heart failure by detecting differences between histograms generated from heart rate values and activity level values collected at different times.

13. The method of claim 12 wherein detecting differences between histograms generated from heart rate values and activity level values collected at different times comprises:

deriving a numerical value (L) representative of a lag between at a plurality of histograms generated from heart rate values and activity level values collected over a plurality of days; and

tracking changes in L over the plurality of days.

14. The method of claim 13 wherein a positive value of L is indicative of a regression in heart failure;

whereas a negative value of L is indicative of a progression of heart failure.

15. The method of claim 1 wherein evaluating heart failure within the patient comprises detecting heart failure.

16. The method of claim 1 wherein evaluating heart failure, if any, within the patient comprises determining the severity of heart failure.

17. The method of claim 1 wherein evaluating heart failure within the patient comprises tracking changes in the severity of heart failure.

18. The method of claim 15 wherein tracking changes in the severity of heart failure is performed to identify any significant progression in heart failure.

19. The method of claim 1 further comprising controlling delivery of therapy in response to the evaluation of heart failure.

20. The method of claim 19 wherein the implantable medical device is capable of biventricular cardiac pacing and wherein controlling delivery of therapy comprises:

delivering cardiac resynchronization therapy (CRT) to the heart of the patient.

21. The method of claim 19 wherein an implantable drug pump is provided and wherein delivering therapy comprises delivering heart failure drug therapy to the patient using the drug pump.

22. The method of claim 1 wherein an implantable warning device is provided and further comprising generating warning signals based on the evaluation of heart failure.

23. The method of claim 1 wherein an external warning device is provided and further comprising transmitting appropriate signals to the external warning device based on the evaluation of heart failure.

24. The method of claim 1 further comprising controlling storage of diagnostic information indicative of the evaluation of heart failure.

25. A method for evaluating heart failure within a patient using an implantable medical device, the method comprising:

detecting values representative of patient heart rate and corresponding activity levels for the patient during periods of time when the patient is active;

deriving individual cardiac fitness values by calculating ratios of rest-rate adjusted heart rate values to corresponding activity level values for each of a plurality of pairs of heart rate values and corresponding activity level values detected during the periods of time while the patient is active, where rest rate is a predetermined rest heart rate of the patient;

generating a histogram based on the individual cardiac fitness values; and

evaluating the heart failure, if any, within the patient based on a numerical measure of the histogram.

26. A system for evaluating heart failure within a patient for use with an implantable medical device, the system comprising:

a detection system operative to detect values representative of heart rate and corresponding activity levels for the patient during a period of time when the patient is active;

a derivation unit operative to derive a cardiac fitness value based on heart rate and corresponding activity levels detected during the period of time when the patient is active and on a predetermined rest heart rate of the patient; and

a heart failure evaluation unit operative to evaluate heart failure, if any, within the patient based on the cardiac fitness values.

27. A system for detecting the progression of congestive heart failure (CHF) within a patient using an implantable medical device, the comprising:

means for detecting values representative of heart rate and corresponding activity levels for the patient during a period of time when the patient is active;

means for deriving derive a cardiac fitness value based on heart rate and corresponding activity levels detected during the period of time when the patient is active and on a predetermined rest heart rate of the patient;

means for evaluating heart failure, if any, within the patient based on the cardiac fitness values; and

means for of controlling delivery of therapy in response to the evaluation of heart failure.