System and method for monitoring diastolic function using an implantable medical device

• US 8,280,523 B2
• Filed: 12/22/2008
• Issued: 10/02/2012
• Est. Priority Date: 12/22/2008
• Status: Active Grant

• Current Assignee: Pacesetter Incorporated (Abbott Laboratories Incorporated)
• Original Assignee: Pacesetter Incorporated (Abbott Laboratories Incorporated)
• Inventors: Keel, Allen, Koh, Steve, Farazi, Taraneh Ghaffari
• Primary Examiner(s): Layno, Carl H.
• Assistant Examiner(s): MORALES, JON ERIC C
• Application Number:
  US12/341,355
• Publication Number:
  US 20100161006A1
• Time in Patent Office: 1,380 Days
• Field of Search: 607/62, 607/17, 607/27, 607/28, 607/9
• US Class Current: 607/62
• 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 1/36507 controlled by gradient or slope of the heart potential
• CPC Class Codes: A61N 1/368 comprising more than one electrode co-operating with different heart regions A61N1/3622, A61N1/3627 take precedence
• CPC Class Codes: A61N 1/3702 Physiological parameters A61N1/365 takes precedence; evoked response A61N1/371
• CPC Class Codes: A61N 1/3712 Auto-capture, i.e. automatic adjustment of the stimulation threshold

Abstract

Diastolic function is monitored within a patient using a pacemaker or other implantable medical device. In one example, the implantable device uses morphological parameters derived from the T-wave evoked response waveform as proxies for ventricular relaxation rate and ventricular compliance. In particular, the magnitude of the peak of the T-wave evoked response is employed as a proxy for ventricular compliance. The maximum slew rate of the T-wave evoked response following its peak is employed as a proxy for ventricular relaxation. A metric is derived from these proxy values to represent diastolic function. The metric is tracked over time to evaluate changes in diastolic function. In other examples, specific values for ventricular compliance and ventricular relaxation are derived for the patient based on the T-wave evoked response parameters.

Claims

1. A method for use with an implantable medical device for implant within a patient, the method comprising:

detecting ventricular repolarization evoked response (ER) morphological parameters within the patient;

determining parameters representative of diastolic function for the patient from the ventricular repolarization ER morphological parameters; and

controlling at least one device function based on the parameters representative of diastolic function.

2. The method of claim 1 wherein detecting ventricular repolarization ER morphological parameters includes detecting a maximum post-peak T-wave ER slew rate.

3. The method of claim 2 wherein detecting the maximum post-peak T-wave ER slew rate includes detecting the peak of the T-wave ER and then determining a maximum rate of change of a magnitude of the T-wave ER following the peak.

4. The method of claim 2 wherein determining parameters representative of diastolic function includes employing the maximum post-peak T-wave ER slew rate as a proxy for a ventricular relaxation rate of the patient.

5. The method of claim 2 wherein determining parameters representative of diastolic function includes determining a ventricular relaxation rate of the patient from the maximum post-peak T-wave ER slew rate.

6. The method of claim 5 wherein determining the ventricular relaxation rate from the maximum post-peak T-wave ER slew rate includes estimating the ventricular relaxation rate based on a predetermined correlation between the maximum post-peak T-wave ER slew rate and the ventricular relaxation rate of the patient.

7. The method of claim 6 wherein estimating the ventricular relaxation rate includes calculating:

Ventricular Relaxation Rate=f₁(T-wave_ER_SlewRate)

where T-wave_ER_SlewRate represents the maximum post-peak T-wave ER slew rate of the patient and f₁( ) is a predetermined function relating the maximum post-peak T-wave ER slew rate with the ventricular relaxation rate of the patient.

8. The method of claim 1 wherein detecting ventricular repolarization ER morphological parameters includes detecting a T-wave ER peak magnitude.

9. The method of claim 8 wherein determining parameters representative of diastolic function includes employing the T-wave ER peak magnitude as a proxy for a ventricular compliance of the patient.

10. The method of claim 8 wherein determining parameters representative of diastolic function for the patient includes determining ventricular compliance for the patient from the T-wave ER peak magnitude.

11. The method of claim 10 wherein determining ventricular compliance values from the T-wave ER peak magnitude includes estimating ventricular compliance based on a predetermined correlation between T-wave ER peak magnitude and ventricular compliance within the patient.

12. The method of claim 11 wherein estimating the ventricular compliance based on a predetermined correlation between the T-wave ER peak magnitude and the ventricular compliance includes calculating:

Ventricular Compliance=f₂(1/T-wave_ER_Peak_Mag)

where T-wave_ER_Peak_Mag represents the T-wave ER peak magnitude of the patient and f₂( ) is a predetermined conversion function relating the T-wave ER magnitude with the ventricular compliance within the patient.

13. The method of claim 1 wherein determining parameters representative of diastolic function includes determining ventricular relaxation rates and ventricular compliance values for the patient and wherein the method further includes calculating a diastolic function metric for the patient from the ventricular relaxation rates and the ventricular compliance values.

14. The method of claim 13 wherein calculating a diastolic function metric from the ventricular relaxation rates and the ventricular compliance values includes calculating:

Diastolic_Function=Vent_Relaxation*k₁+Vent_Compliance*k₂

where Vent_Relaxation and Vent_Compliance are representative of the ventricular relaxation rates and the ventricular compliance values, respectively, where k₁ and k₂ are predetermined weighting constants for the relaxation rate and the compliance respectively, and where k₁ and k₂ sum to 1.

15. The method of claim 14 further including monitoring diastolic dysfunction within the patient based on the diastolic function metric.

16. The method of claim 15 wherein monitoring diastolic dysfunction within the patient based on the diastolic function metric includes detecting a change in the metric from an initial baseline value derived for the patient.

17. The method of claim 15 wherein monitoring diastolic dysfunction includes detecting one or more of mild diastolic dysfunction, moderate diastolic dysfunction and severe diastolic dysfunction.

18. The method of claim 13 further including controlling the delivery of therapy provided by the device based on the diastolic function metric.

19. The method of claim 1 further including controlling the delivery of therapy provided by the device based on any of the parameters representative of diastolic function.

20. The method of claim 1 further including controlling rate adaptive pacing provided by the device based on any of the parameters representative of diastolic function.

21. A system for use with an implantable medical device for implant within a patient, the system comprising:

a ventricular repolarization evoked response (ER) morphological parameter detection unit operative to detect ventricular repolarization ER morphological parameters within the patient; and

a diastolic function determination unit operative to determine parameters representative of diastolic function for the patient from the ventricular repolarization ER morphological parameters.

22. The system of claim 21 further including a controller operative to control at least one device function based on the parameters representative of diastolic function.

23. The system of claim 21 wherein the ventricular repolarization ER morphological parameter detection unit includes a T-wave ER slew rate detection unit operative to detect a maximum post-peak T-wave ER slew rate within the patient, and wherein the diastolic function determination unit includes a ventricular relaxation rate detection unit operative to determine the ventricular relaxation rate for the patient based on the T-wave ER slew rate.

24. The system of claim 21 wherein the ventricular repolarization ER morphological parameter detection unit includes a T-wave ER peak magnitude detection unit operative to detect a peak T-wave ER magnitude within the patient, and wherein the diastolic function determination unit includes a ventricular compliance detection unit operative to determine a ventricular compliance value for the patient based on the peak T-wave ER magnitude.

25. The system of claim 21 wherein the diastolic function determination unit includes a diastolic function metric determination unit operative to determine a diastolic function metric value for the patient from the ventricular repolarization ER morphological parameters.

26. The system of claim 25 further including a controller operative to control the delivery of warnings provided by the device based on the diastolic function metric.

27. A method for use with an implantable medical device for implant within a patient, the method comprising:

detecting ventricular repolarization evoked response (ER) morphological parameters within the patient; and

monitoring diastolic function within the patient using the ventricular repolarization ER morphological parameters.