Cardiopulmonary functional status assessment via heart rate response detection by implantable cardiac device

• US 7,869,877 B2
• Filed: 09/10/2007
• Issued: 01/11/2011
• Est. Priority Date: 08/09/2004
• Status: Active Grant

• Current Assignee: Cardiac Pacemakers Incorporated (Boston Scientific Corporation)
• Original Assignee: Cardiac Pacemakers Incorporated (Boston Scientific Corporation)
• Inventors: Kadhiresan, Veerichetty, Baker, Lemont, Hopper, Donald, Fogoros, Richard
• Primary Examiner(s): Layno; Carl H
• Assistant Examiner(s): PATEL, NATASHA
• Application Number:
  US11/852,845
• Publication Number:
  US 20080004668A1
• Time in Patent Office: 1,219 Days
• Field of Search: 607/9, 607 17- 19, 600/509, 600/513, 600/519
• US Class Current: 607/19
• 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: A61N 1/365 controlled by a physiological parameter, e.g. heart potential evoked response A61N1/371
• CPC Class Codes: A61N 1/36521 the parameter being derived from measurement of an electrical impedance
• CPC Class Codes: A61N 1/36542 controlled by body motion, e.g. acceleration
• CPC Class Codes: A61N 1/3702 Physiological parameters A61N1/365 takes precedence; evoked response A61N1/371

Abstract

An implantable cardiac device is configured and programmed to assess a patient'"'"'s cardiopulmonary function by evaluating the patient'"'"'s heart rate response. Such evaluation may be performed by computing a heart rate response slope, defined as the ratio of an incremental change in intrinsic heart rate to an incremental change in measured activity level. The heart rate response slope may then be compared with a normal range to assess the patient'"'"'s functional status.

Claims

1. A cardiac device, comprising:

one or more sensing amplifiers for generating intra-cardiac electrogram signals;

a controller for detecting intrinsic cardiac activity and measuring an intrinsic heart rate from the electrogram signals;

an activity level sensor interfaced to the controller for measuring a parameter related to a patient'"'"'s level of physical activity;

wherein the controller is programmed to construct a historical record of activity level versus heart rate, referred to as a heart rate response profile;

wherein the controller is programmed to compute a heart rate response slope from the heart rate response profile, defined as the ratio of an incremental change in intrinsic rate to an incremental change in measured activity level, and compute the rate of change of the heart rate response slope;

wherein the controller is programmed to collect periodic maximum heart rates over time and derive a maximum intrinsic heart rate parameter therefrom indicative of the maximum heart rate the patient is able to attain;

a pulse generator for pacing a cardiac chamber through a pacing channel, wherein the controller is programmed to control the delivery of pacing pulses in accordance with a programmed mode; and

,

wherein the controller is programmed to switch to a rate-adaptive pacing mode if the rate of change of the heart rate response slope and maximum intrinsic heart rate parameters indicate chronotropic incompetence.

2. The device of claim 1 wherein the heart rate response profile is a data structure containing a plurality of heart rates, each heart rate being associated with a discrete activity level.

3. The device of claim 2 wherein the controller is programmed to update the heart rate response profile by averaging a currently measured heart rate with the heart rate associated with an activity level corresponding to a currently measured activity level.

4. The device of claim 2 wherein the controller is programmed to update the heart rate response profile by averaging a currently measured heart rate with the heart rate associated with an activity level corresponding to a currently measured activity level if activity level measurements taken over an N second interval meet a predefined stability criterion.

5. The device of claim 1 wherein the controller is programmed to set an alarm flag if the heart rate response slope is not within a normal range as defined by upper and lower limit values.

6. The device of claim 5 further comprising:

a telemetry interface for communicating with a remote monitoring device; and

,

wherein the controller is programmed to send an alert message via the telemetry interface if an alarm flag is set.

7. The device of claim 1 wherein the controller is further programmed to calculate a response factor for rate-adaptive pacing based upon previously measured heart rates and activity levels.

8. The device of claim 1 wherein the controller is further programmed to compute a heart rate response parameter and to set an alarm flag if the heart rate response parameter is not within a normal range as defined by upper and lower limit values.

9. The device of claim 1 further comprising a posture sensor and wherein the controller is programmed to include postural data in the heart rate response profile.

10. A method for operating a cardiac device, comprising:

generating intra-cardiac electrogram signals and measuring an intrinsic heart rate from the electrogram signals;

measuring a parameter related to a patient'"'"'s level of physical activity;

constructing a historical record of activity level versus heart rate, referred to as a heart rate response profile

monitoring a patient'"'"'s cardiopulmonary functional status by computing a heart rate response slope from the heart rate response profile, defined as the ratio of an incremental change in intrinsic rate to an incremental change in measured activity level, and computing a rate of change of the heart rate response slope;

collecting periodic maximum heart rates over time and deriving a maximum intrinsic heart rate parameter from the collected periodic maximum heart rates that reflects the maximum intrinsic heart rate that the patient is able to attain over a defined period of time;

pacing a cardiac chamber in accordance with a programmed mode; and

,

switching to a rate-adaptive pacing mode if the rate of change of the heart rate response slope and maximum intrinsic heart rate parameters indicate chronotropic incompetence.

11. The method of claim 10 wherein the heart rate response profile is a data structure containing a plurality of heart rates, each heart rate being associated with a discrete activity level.

12. The method of claim 11 further comprising updating the heart rate response profile by averaging a currently measured heart rate with the heart rate associated with an activity level corresponding to a currently measured activity level.

13. The method of claim 12 further comprising collecting postural data and wherein the heart rate response profile includes the postural data.

14. The method of claim 11 further comprising updating the heart rate response profile by averaging a currently measured heart rate with the heart rate associated with an activity level corresponding to a currently measured activity level if activity level measurements taken over an N second interval meet a predefined stability criterion.

15. The method of claim 10 further comprising setting an alarm flag if the heart rate response slope is not within a normal range as defined by upper and lower limit values.

16. The method of claim 15 further comprising send an alert message via a telemetry interface if an alarm flag is set.

17. The method of claim 10 further comprising calculating a response factor for rate-adaptive pacing based upon previously measured heart rates and activity levels.

18. The method of claim 10 further comprising computing a heart rate response parameter and setting an alarm flag if the heart rate response parameter is not within a normal range as defined by upper and lower limit values.

19. A cardiac device, comprising:

one or more sensing channels for generating intra-cardiac electrogram signals;

a controller for detecting intrinsic cardiac activity and measuring an intrinsic heart rate from the electrogram signals;

an activity level sensor interfaced to the controller for measuring a parameter related to a patient'"'"'s level of physical activity;

wherein the controller is programmed to construct a historical record of activity level versus heart rate, referred to as a heart rate response profile;

wherein the controller is programmed to compute a heart rate response slope from the heart rate response profile, defined as the ratio of an incremental change in intrinsic rate to an incremental change in measured activity level;

at least two pacing channels for pacing the right and left ventricles, wherein the controller is programmed to control the delivery of pacing pulses in accordance with a programmed pacing mode; and

,

wherein the controller is programmed to initiate cardiac resynchronization therapy if the heart rate response slope increases to a specified extent.

20. The device of claim 19 wherein the controller is programmed to adjust a resynchronization parameter selected from the AV delay or biventricular offset interval if the heart rate response slope increases to a specified extent.

21. The device of claim 19 wherein the controller is programmed to update the heart rate response profile by averaging a currently measured heart rate with the heart rate associated with an activity level corresponding to a currently measured activity level.

22. The device of claim 19 wherein the controller is programmed to update the heart rate response profile by averaging a currently measured heart rate with the heart rate associated with an activity level corresponding to a currently measured activity level if activity level measurements taken over an N second interval meet a predefined stability criterion.