Method and apparatus to continuously optimize the A-V delay in a dual chamber pacemaker

• US 5,466,245 A
• Filed: 11/15/1994
• Issued: 11/14/1995
• Est. Priority Date: 11/15/1994
• Status: Expired due to Term

• Current Assignee: Cardiac Pacemakers Incorporated (Boston Scientific Corporation)
• Original Assignee: Cardiac Pacemakers Incorporated (Boston Scientific Corporation)
• Inventors: Spinelli, Julio C., Heemels, Jan P.
• Primary Examiner(s): Kamm, William E.
• Assistant Examiner(s): SCHAETZLE, KENNEDY
• Application Number:
  US08/339,815
• Time in Patent Office: 364 Days
• Field of Search: 607/17, 607/9, 607/16, 607/27, 607/25, 128/703, 128/706
• US Class Current: 607/17
• 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 1/36542 controlled by body motion, e.g. acceleration
• CPC Class Codes: A61N 1/36592 controlled by the heart rate variability
• CPC Class Codes: A61N 1/3682 with a variable atrioventricular delay

Abstract

A DDD-type cardiac pacemaker having a microprocessor-based controller is programmed to automatically determine and utilize and optimize A-V delay for the patient in whom the device is implanted. The microprocessor-based controller periodically changes the A-V delay and then computes heart rate variability over an insuing predetermined period. The particular A-V delay value associated with the minimum heart rate variability index is determined to be the optimum. Heart rate variability may be determined by performing a power spectrum analysis on cyclic variations in R-R intervals, preferably using a FFT signal processing chip, or by a time domain analysis based upon the standard deviation of R-R intervals during a prescribed period of time and a calculated value of respiratory sinus arrhythmia. The apparatus is also operative to optimize the A-V delay interval following a change in the pacing mode of the DDD-type pacemaker.

Claims

1. Cardiac stimulating apparatus for use with a patient comprising, in combination:

(a) means for sensing atrial depolarization signals;

(b) means for sensing ventricular depolarization signals;

(c) means for stimulating ventricular tissue; and

(d) microprocessor-based controller means coupled to said means for sensing ventricular depolarization signals for determining a heart rate variability index (HRV_i) during a predetermined time interval, said controller means further being coupled to said means for sensing atrial depolarization signals for establishing an optimum A-V delay interval corresponding to a minimum HRV_i, said controller means coupled in controlling relation to said means for stimulating ventricular tissue for causing said ventricular tissue to be stimulated in at least one ventricular chamber after expiration of said optimum A-V delay interval following the sensing of an immediately preceding atrial depolarization signal.

2. The cardiac stimulating apparatus as in claim 1 wherein said microprocessor-based controller includes means for determining the said HRV_i from a power spectrum analysis of cyclic variations in the rate at which said ventricular depolarization signals are occurring.

3. The cardiac stimulating apparatus as in claim 2 wherein said HRV_i is the ratio of low frequency power to high frequency power found in said power spectrum analysis.

4. The cardiac stimulating apparatus as in claim 1 wherein said microprocessor-based controller includes means for determining the said HRV_i from the standard deviation of R-R intervals of the heart during a predetermined time interval and respiratory sinus arrhythmia from measured values of mean absolute differences between each R-R interval and a successive one.

5. The cardiac stimulating apparatus as in claim 1 and further including means in said cardiac stimulating apparatus for indicating the activity state of a patient and means responsive to said activity state indicating means for inhibiting the determination of said optimum A-V interval when said patient is awake.

6. The cardiac stimulating apparatus as in claim 3 wherein said microprocessor-based controller is programmed to periodically minimize the patient'"'"'s HRV_i by controllably modifying said optimum A-V delay interval.

7. The cardiac stimulator as in claim 6 wherein said patient'"'"'s HRV_i is minimized at a predetermined frequency.

8. The cardiac stimulating apparatus as in claim 7 wherein the frequency at which said HRV_i is minimized is daily.

9. The cardiac stimulating apparatus as in claim 6 wherein the frequency at which said HRV_i is minimized is weekly.

10. The cardiac stimulating apparatus as in claim 6 wherein the frequency at which said HRV_i is minimized is monthly.

11. A method for setting the A-V delay of an implantable DDD pacemaker of the type having a means for sensing atrial events, means for sensing ventricular events, means for stimulating ventricular tissue and a programmable microprocessor-based controller coupled to said atrial and ventricular sensing means and to said means for stimulating ventricular tissue comprising the steps of:

(a) establishing an initial A-V delay interval between the sensing of an atrial event and an actuation of said means for stimulating ventricular tissue;

(b) measuring a heart rate variability index (HRV_i) of a patient in whom said pacemaker is implanted for a predetermined period of time following the establishing of each A-V delay interval and determining an average value for said period;

(c) incrementing the length of said initial A-V interval by a predetermined amount during iterative cycles until a predetermined A-V interval limit is reached and for each new value thereof computing HRV_i over a predetermined length of time;

(d) storing said A-V delay interval and the associated HRV_i following each iteration of step (c);

(e) setting said A-V interval to the value associated with the minimum HRV_i stored after said A-V interval limit has been reached.

12. The method as in claim 11 wherein measuring a HRV_i includes the steps of:

(a) measuring an RR interval of the heart over time using said means for sensing said ventricular events and determining a corresponding heart rate value;

(b) performing a power spectrum analysis on the measured heart rate value;

(c) determining from said power spectrum analysis the power associated with low frequency components and high frequency components; and

(d) forming the ratio of low frequency power to high frequency power.

13. The method as in claim 11 and further including the step of inhibiting the execution of steps (a)-(e) if said patient is awake.

14. The method as in claim 12 and further including the step of periodically changing the A-V delay interval by a known increment and measuring the effect of such change on the patient'"'"'s HRV_i.

15. The method as in claim 14 and further including the step of determining whether a change in the A-V delay interval causes an increase or a decrease in said HRV_i and subsequently changing the A-V delay interval in a direction to minimize said HRV_i.

16. The method as in claim 11 wherein measuring a HRV_i includes the steps of:

(a) measuring an R-R interval of the heart over a predetermined time interval using said means for sensing said ventricular events and determining a standard deviation (SD);

(b) computing a respiratory sinus arrythmia (RSA) value from the mean absolute difference between each R-R interval and a succeeding one; and

(c) forming the ratio of SD/RSA.

17. A method of determining the optimum pacing mode for a cardiac stimulator of the type having a means for sensing atrial events, means for sensing ventricular events, means for stimulating ventricular tissue, a means for stimulating atrial tissue and a programmable microprocessor-based controller coupled to said atrial and ventricular sensing means and to said means for stimulating ventricular tissue and said means for stimulating atrial tissue comprising the steps of:

(a) programming the stimulator to operate in a first pacing mode;

(b) thereafter establishing an initial A-V delay interval between the sensing of an atrial event and the actuation of said means for stimulating ventricular tissue;

(c) measuring a heart rate variability index (HRV_i) of a patient in whom said cardiac stimulator is implanted for a predetermined period of time following the establishing of each A-V delay interval and determining an average value for said period;

(d) incrementing the length of said initial A-V interval by a predetermined amount during iterative cycles until a predetermined A-V interval limit is reached and for each new value thereof, computing said HRV_i over a predetermined length of time;

(e) storing said A-V delay interval and its associated HRV_i following each iteration of step (d);

(f) determining the average HRV_i ;

(g) programming the cardiac stimulator to operate in a second pacing mode different from said first pacing mode;

(h) repeating steps b through f;

(i) comparing the average HRV_i computed in step f with that computed in step h; and

(j) programming the cardiac stimulator to operate in the mode yielding the minimum average HRV_i.

18. The method of determining the optimum pacing mode as in claim 17 wherein said pacing modes are selected from the group including sensing atrial events and sensing ventricular events, sensing atrial events and stimulating ventricular tissue, stimulating atrial tissue and sensing ventricular tissue, and stimulating atrial tissue and stimulating ventricular tissue.

19. The method of determining the optimum pacing mode as in claim 17 wherein measuring a HRV_i includes the steps of:

(a) measuring an R-R interval of the heart over time using said means for sensing said ventricular events and determining a corresponding heart rate value;

(b) performing a power spectrum analysis on the measured heart rate value;

(c) determining from said power spectrum analysis the power associated with low frequency components and high frequency components; and

(d) forming the ratio of low frequency power to high frequency power.

20. The method as in claim 17 and further including the step of periodically changing the A-V delay interval by a known increment and measuring the effect of such change on the patient'"'"'s HRV_i.

21. The method as in claim 20 and further including the step of determining whether a change in the A-V delay interval causes an increase or a decrease in said HRV_i and subsequently changing the A-V delay interval in a direction to minimize said HRV_i.

22. The method as in claim 17 wherein measuring a HRV_i includes the steps of:

(a) determining the standard deviation (SD) of the R-R intervals of the heart during a predetermined time interval;

(b) determining the respiratory sinus arrhythmia (RSA) from measured values of the mean absolute difference between each R-R interval and the successive one; and

(c) computing HRV_i as the ratio equal to SK/RSA.