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

• US 8,874,213 B2
• Filed: 08/31/2012
• Issued: 10/28/2014
• 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:
  US13/601,569
• Publication Number:
  US 20120330371A1
• Time in Patent Office: 788 Days
• Field of Search: 607/9, 607/17, 607/28
• US Class Current: 607/25
• 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 a T-wave evoked response (ER) slew rate within the patient;

estimating a ventricular relaxation rate of the patient from the T-wave ER slew rate; and

controlling at least one device function based on the ventricular relaxation rate.

2. The method of claim 1, wherein detecting

the T-wave ER slew rate comprises:

detecting a peak magnitude of the absolute value of a T-wave; and

detecting a maximum rate of change of the T-wave magnitude after the peak.

3. The method of claim 2 further comprising:

pacing the patient'"'"'s ventricles;

collecting cardiac signal data over a predetermined period of time comprising a plurality of hearbeats;

detecting the T-wave ER slew rate for each heartbeat;

storing the detected T-wave ER slew rates; and

averaging the detecited T-wave ER slew rates, wherein estimating a ventricular relaxation rate of the patient from the T-wave ER slew rate comprises estimating the ventricular relaxation rate from the average of the T-wave ER slew rates.

4. The method of claim 3 further comprising calculating a

diastolic function metric using the average of the T-wave ER slew rates.

5. The method of claim 1, wherein estimating the ventricular

relaxation rate includes calculating:

Ventricular Relaxation Rate=f₁(T-wave_ER_SlewRate), wherein T-wave_ER_SlewRate is the T-wave ER slew rate,

wherein f₁( )is a predetermined function for converting the T-wave ER slew rate to the ventricular relaxation rate of the patient.

6. The method of claim 5, wherein f₁( )is a second-order function or an exponential function.

7. The method of claim 6, further comprising obtaining actual values of ventricular relaxation rates using echocardiography, and determining f₁( )by comparing actual values of ventricular relaxation rates obtained via echocardiography to actual values of T-wave_ER_SlewRate.

8. The method of claim 5, wherein determining f₁( )includes calculating:

f₁( )=1-exp(-a₁ *T-wave_ER_SlewRate),

the method further comprising measuring real ventricular relaxation rate values using echocardiography, and using the real ventricular relaxation rates to calibrate a₁.

9. The method of claim 8, wherein the real ventricular relaxation rates are obtained for multiple different heart rates.

10. The method of claim 1 further comprising:

determining a change in T-wave ER slew rate; and

determining a change in the ventricular relaxation rate from the change in T-wave ER slew rate.

11. The method of claim 1 further comprising:

estimating a ventricular compliance value of the patient; and

determining a diastolic function metric for the patient based on the ventricular relaxation rate and the ventricular compliance value.

12. The method of claim 11, wherein

determining the diastolic function metric for the patient includes calculating:

Diastolic_Function =Vent_Relaxation*k₁ +Vent_Compliance*k₂,

wherein Vent_Relaxation and Vent_Compliance are representative of the ventricular relaxation rates and the ventricular compliance values,

respectively, and wherein k₁ and k₂ are predetermined weighting constants for the relaxation rate and the compliance, respectively, and where k₁ and k₂ sum to 1.

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

detecting a T-wave evoked res Manse (ER) peak magnitude within the patient;

estimating a ventricular compliance value of the patient from the T-wave ER peak magnitude; and

controlling at least one device function based on the ventricular compliance value, wherein estimating a ventricular compliance value includes calculating;

ventricular compliance =f₂(1/T-wave_ER_Peak_Mag),

wherein T-wave_ER_Peak₁₃ Mag is the T-wave ER peak magnitude of the patient and f₂( )is a predetermined function for relating the reciprocal of the T-wave ER peak magnitude of the patient to the ventricular compliance value of the patient.

14. The method of claim 13 further comprising:

pacing the patient'"'"'s ventricles;

collecting cardiac signal data over a predetermined period of time comprising a plurality of heartbeats;

detecting the T-wave ER peak magnitude for each of the plurality of heartbeats;

storing the detecited T-wave ER peak magnitudes; and

averaging the detecited T-wave ER peak magnitudes, wherein estimating the ventricular compliance value of the patient from the T-wave ER peak magnitude comprises estimating the ventricular compliance value from the average of the T-wave peak magnitudes.

15. The method of claim 13 further comprising:

determining a change in T-wave ER peak magnitude over a period of time; and

determining a change in the ventricular compliance value from the change in T-wave ER peak magnitude.

16. The method of claim 13, wherein f₂( )is a second-order function or an exponential function.

17. The method of claim 16, further comprising obtaining actual values of ventricular compliance using echocardiography, and wherein f₂( )is predetermined by comparing actual values of ventricular compliance obtained via echocardiography to actual values of T-wave_ER_Peak_Mag.

18. The method of claim 13, wherein f₂( )is calculated using the formula:

f₂( )=1−

exp(−

a₂*(1-wave_ER_Peak₁₃ Mag)), the method further comprising measuring real ventricular compliance values and corresponding T-wave ER peak magnitudes using echocardiography, and using the real ventricular compliance and corresponding T-wave ER peak magnitudes to calibrate a₂.

19. The method of claim 18, wherein the real ventricular compliance values and corresponding T-wave ER peak magnitudes are obtained for a plurality of different heart rates.