Method and apparatus for determining changes in heart failure status

• US 7,769,437 B2
• Filed: 12/12/2005
• Issued: 08/03/2010
• Est. Priority Date: 11/15/2001
• Status: Expired due to Fees

• Current Assignee: Cardiac Pacemakers Incorporated (Boston Scientific Corporation)
• Original Assignee: Cardiac Pacemakers Incorporated (Boston Scientific Corporation)
• Inventors: Warren, Jay A., Spinelli, Julio C., Zhu, Qingsheng, KenKnight, Bruce H.
• Primary Examiner(s): Manuel; George
• Assistant Examiner(s): Wieland; Robert N
• Application Number:
  US11/299,876
• Publication Number:
  US 20060089679A1
• Time in Patent Office: 1,695 Days
• Field of Search: 607/32, 607 1- 9, 600515-519
• US Class Current: 600/513
• 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 1/36585 controlled by two or more physical parameters

Abstract

A method for operating a cardiac rhythm management device in which a clinical state vector is computed as a combination of a plurality of parameters related to a patient'"'"'s heart failure status and compared to a previously computed clinical state vector to determine a clinical trajectory indicative of changes in the patient'"'"'s heart failure status. Such detected changes in status can be used both as a clinical tool to evaluate treatment and to automatically adjust the operation of the device.

Claims

1. A system, comprising:

an implantable device having one or more sensing modalities and pacing circuitry for delivering pacing therapy;

an external programmer for the implantable device;

a telemetry interface enabling communication between the external programmer and the implantable device;

wherein the external programmer is programmed to compute a clinical state vector as a combination of a plurality of parameters related to a patient'"'"'s heart failure status, wherein the plurality of parameters define an n-dimensional vector space with n being the number of parameters and with each parameter mapped to an ordinal scale that represents a coordinate axis in the n-dimensional vector space, and further wherein the n parameters include at least one parameter derived from data transmitted by the implantable device;

wherein the external programmer is further programmed to compute a difference vector between the computed clinical state vector and a previously computed state vector, wherein the magnitude of the difference vector indicates the extent of change in the patient'"'"'s heart failure status and the direction of the difference vector indicates whether the patient'"'"'s heart failure status is improving or worsening; and

,

wherein the implantable device is programmed to change a pacing configuration for delivering pacing therapy if the computed difference vector exceeds a specified limit value.

2. The system of claim 1 wherein the at least one parameter derived from data transmitted by the implantable device corresponds to a PR interval in an electrogram.

3. The system of claim 1 wherein the at least one parameter derived from data transmitted by the implantable device corresponds to a QRS duration in an electrogram.

4. The system of claim 1 wherein the at least one parameter derived from data transmitted by the implantable device corresponds to an inter-ventricular delay between senses in the right and left ventricles.

5. The system of claim 1 wherein the plurality of parameters includes a frequency of atrial fibrillation occurrence over a specified period of time.

6. The system of claim 1 wherein the plurality of parameters includes a frequency at which a ventricular tachycardia converts to ventricular fibrillation over a specified period of time.

7. The system of claim 1 wherein the plurality of parameters includes a measure of heart rate variability.

8. The system of claim 1 wherein the plurality of parameters includes a measured body weight of the patient.

9. The system of claim 1 wherein the plurality of parameters includes a measured or derived left ventricular end diastolic pressure.

10. The system of claim 1 wherein the plurality of parameters includes a measured or derived systolic pressure index.

11. The system of claim 1 wherein the plurality of parameters includes a measured or derived pulse pressure index.

12. The system of claim 1 wherein the plurality of parameters includes a measured or derived maximum left ventricular dP/dt index.

13. The system of claim 1 wherein the plurality of parameters includes a frequency of ectopic beats over a specified period of time.

14. The system of claim 1 wherein the plurality of parameters includes a ratio of minute ventilation to activity level.

15. The system of claim 1 wherein the external programmer is further programmed to compute a clinical trajectory index CT computed as a sum of the weighted parameters:

CT=Σ

a_iX_i

where a weighting factor a_i is assigned to each parameter X_i based upon its clinical significance and the summation is carried out from i=1 to N, N representing the total number of parameters.

16. An external programmer for an implantable medical device, comprising:

means for computing a clinical state vector as a combination of a plurality of parameters related to a patient'"'"'s heart failure status, wherein the plurality of parameters define an n-dimensional vector space with n being the number of parameters and with each parameter mapped to an ordinal scale that represents a coordinate axis in the n-dimensional vector space, and further wherein the n parameters include at least one parameter derived from data transmitted by the implantable device;

means for computing a difference vector between the computed clinical state vector and a previously computed state vector, wherein the magnitude of the difference vector indicates the extent of change in the patient'"'"'s heart failure status and the direction of the difference vector indicates whether the patient'"'"'s heart failure status is improving or worsening; and

,

means for communicating with the implantable device to cause the implantable device to change a pacing configuration for delivering pacing therapy if the computed difference vector exceeds a specified limit value.

17. The external programmer of claim 16 wherein the plurality of parameters includes a measured or derived left ventricular end diastolic pressure.

18. The external programmer of claim 16 wherein the plurality of parameters includes a measured or derived systolic pressure index.

19. The external programmer of claim 16 wherein the plurality of parameters includes a measured or derived pulse pressure index.

20. The external programmer of claim 16 wherein the plurality of parameters includes a measured or derived maximum left ventricular dP/dt index.