Method for assessing cardiac functional status

• US RE42,836 E1
• Filed: 10/03/2007
• Issued: 10/11/2011
• Est. Priority Date: 04/18/2000
• Status: Active Grant

• Current Assignee: Cardiac Pacemakers Incorporated (Boston Scientific Corporation)
• Original Assignee: Cardiac Pacemakers Incorporated (Boston Scientific Corporation)
• Inventors: Kadhiresan, Veerichetty, Sanders, Richard S., KenKnight, Bruce H., Sun, Weimin
• Primary Examiner(s): Manuel; George
• Assistant Examiner(s): Wieland; Robert N
• Application Number:
  US11/906,742
• Time in Patent Office: 1,469 Days
• Field of Search: 600/485, 600/526, 600/521, 607/11, 607 17- 21, 607/25, 607/9, 607/91
• US Class Current: 607/19
• CPC Class Codes: A61N 1/36542 controlled by body motion, e.g. acceleration

Abstract

A method for assessing cardiac function suitable for incorporation into an implantable cardiac rhythm management device. By measuring daily exertion levels in accordance with the invention, an assessment of cardiac function can be made that has been found to correlate well with conventional clinical classifications. The invention also provides for assessing cardiac function in conjunction with different pacing schemes designed to treat heart failure and using the assessment to select the best such scheme for the patient.

Claims

1. A cardiac rhythm management device, comprising:

one or more sensing channelsamplifiers for sensing atrial and ventricularcardiac depolarization signals, each channel including an electrode and a sense amplifier;

a pulse generator for delivering pacing pulses to the atrium and/or ventricle;

an exertion level sensor; and

a processor for controlling the delivery of pacing pulses in response to elapsed time intervals and detected depolarization signals in accordance with a programmed mode, wherein the processor is programmed to perform a method comprising;

measuring a moving average over a specified averaging period of exertion levels attained by the patient during daily activities;

extracting daily maximal exertion levels from the measured moving average exertion levels for a specified number of days; and

classifying the patient'"'"'s cardiac functional status based upon the daily maximum daily maximal exertion levels.

2. The device of claim 1 wherein the processor is programmed to automatically adjust a pacing scheme of the device based upon the extracted maximal exertion levels.

3. The device of claim 2 wherein the processor is programmed to perform a testing sequence in which different pacing schemes are tried for predetermined periods and a patient'"'"'s functional status is assessed while each scheme is tried.

4. The device of claim 3 wherein the processor is programmed to insert a wash out period between trials of different pacing schemes.

5. The device of claim 3 wherein the processor is programmed to automatically select for use the pacing scheme resulting in the most improved functional status of a patient as determined by the testing sequence.

6. The device of claim 1 wherein the processor is programmed to activate a diagnostic monitoring operation when there is a change in the patient'"'"'s status as reflected by measured exertion levels.

7. A system for assessing a patent'"'"'s cardiac functional status, comprising:

a sensor adapted to measure an exertion level; and

a processor, coupled to the sensor, the processor adapted to;

calculate a moving averaged exertion level from the measured exertion level over a specified averaging period;

extract a maximal exertion level from the moving averaged exertion levels calculated over a first duration, the first duration including a plurality of the specified averaging periods; and

classify the patient'"'"'s cardiac functional status based on the maximal exertion durations extracted over a second duration, the second duration including a plurality of the first durations.

8. The system of claim 7, wherein the processor includes a first timer to time the specified averaging period, the specified averaging period ranging from 30 seconds to 10 minutes.

9. The system of claim 8, wherein the processor includes a second timer to time the first duration, the first duration being 24 hours.

10. The system of claim 7, wherein the first sensor is one of an accelerometer and a minute ventilation sensor.

11. The system of claim 10, further including a memory adapted to store at least the maximal exertion levels.

12. The system of claim 11, further including a display adapted to present at least the maximal exertion levels.

13. The system of claim 11, further including a drug delivery device adapted to deliver one or more drug therapies to the patient.

14. The system of claim 11, further including:

at least one sensing channel adapted to sense a cardiac signal;

at least one pacing channel adapted to deliver pacing pulses; and

wherein the processor is adapted to control the delivery of the pacing pulses based on the cardiac signal and one of a plurality of pacing schemes, each of the plurality of pacing schemes including a particular pacing mode and a plurality of timing parameters.

15. The system of claim 14, wherein the processor is adapted to test the one of the plurality of pacing schemes and classify the patient'"'"'s cardiac functional status in response to the one of the plurality of pacing schemes.

16. The system of claim 15, wherein the processor is adapted to adjust the one of the pacing schemes based on the classifications of the cardiac functional status associated with two or more of the plurality of the pacing schemes.

17. A cardiac rhythm management device, comprising:

a first sensing channel adapted to sense a first cardiac signal;

a first pacing channel adapted to deliver pacing pulses to a first cardiac site;

a second sensing channel adapted to sense a second cardiac signal;

a second pacing channel adapted to deliver pacing pulses to a second cardiac site;

a first sensor adapted to measure a first exertion level;

a processor, coupled to the first and second sensing channels, the first and second pacing channels, and the first sensor, the processor adapted to;

calculate a moving average exertion level from the measured exertion level over a specified averaging period;

extract a maximal exertion level from the moving average exertion levels calculated over a first duration, the first duration including a plurality of the specified averaging periods;

classify the patient'"'"'s cardiac functional status based on the maximal exertion durations extracted over a second duration, the second duration including a plurality of the first durations; and

control the delivery of the pacing pulses based on at least the first and second cardiac signals and a programmed pacing mode.

18. The device of claim 17, wherein the programmed pacing mode is a programmed rate-adaptive pacing mode, and wherein the processor is adapted to control the delivery of the pacing pulses based on at least the first and second cardiac signals, the first exertion level, and the programmed rate-adaptive pacing mode.

19. The device of claim 18, further including a second sensor adapted to measure a second exertion level, and wherein the processor is adapted to control the delivery of the pacing pulses based on at least the first and second cardiac signals, at least one of the first and second exertion levels, and the programmed rate-adaptive pacing mode.

20. The device of claim 19, wherein the first sensor includes an accelerometer and the second sensor includes a minute ventilation sensor.

21. The device of claim 19, wherein the first sensor includes a minute ventilation sensor and the second sensor includes an accelerometer.

22. The device of claim 17, further including:

a third sensing channel adapted to sense a third cardiac signal;

a third pacing channel adapted to deliver pacing pulses to a third cardiac site; and

wherein the processor is adapted to control the delivery of the pacing pulses based on at least the first, second, and third cardiac signals, and the programmed pacing mode.

23. The device of claim 22, wherein the programmed pacing mode is a programmed rate-adaptive pacing mode, and wherein the processor is adapted to control the delivery of the pacing pulses based on at least the first, second, and third cardiac signals, the first exertion level, and the programmed rate-adaptive pacing mode.

24. The device of claim 23, further including a second sensor adapted to measure a second exertion level, and wherein the processor is adapted to control the delivery of the pacing pulses based on at least the first, second, and third cardiac signals, at least one of the first and second exertion levels, and the programmed rate-adaptive pacing mode.

25. The device of claim 24, wherein the first sensor includes an accelerometer and the second sensor includes a minute ventilation sensor.

26. The device of claim 24, wherein the first sensor includes a minute ventilation sensor and the second sensor includes an accelerometer.

27. A method, comprising:

configuring a cardiac rhythm management device to measure a moving average over a specified averaging period of exertion levels attained by a patient during daily activities;

extracting maximal exertion levels from the moving averages of the exertion levels measured over a specified duration;

classifying the patient'"'"'s cardiac functional status based upon the maximal exertion levels; and

performing a testing sequence in which different pacing schemes are tried for predetermined periods and a patient'"'"'s functional status is assessed for each scheme tried.

28. The method of claim 27 wherein the exertion levels are measured by an accelerometer incorporated into the cardiac rhythm management device.

29. The method of claim 27 wherein the exertion levels are measured by a minute ventilation sensor incorporated into the cardiac rhythm management device.

30. The method of claim 27 wherein the steps are performed automatically at periodic times by an implantable device.

31. The method of claim 27 further comprising transmitting measured and moving averaged exertion levels from the cardiac rhythm management device to an external programmer.