Cardiac rhythm management system with optimization of cardiac performance using heart rate

• US 6,708,061 B2
• Filed: 12/11/2000
• Issued: 03/16/2004
• Est. Priority Date: 04/07/2000
• Status: Active Grant

• Current Assignee: Cardiac Pacemakers Incorporated (Boston Scientific Corporation)
• Original Assignee: Cardiac Pacemakers Incorporated (Boston Scientific Corporation)
• Inventors: Salo, Rodney W., Baker, Kenneth L., Baumann, Lawrence S.
• Primary Examiner(s): Bockelman, Mark
• Application Number:
  US09/734,282
• Publication Number:
  US 20010031993A1
• Time in Patent Office: 1,191 Days
• Field of Search: 607/9, 607/25, 607/27, 607/15, 607/123
• US Class Current: 607/9
• 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 1/3682 with a variable atrioventricular delay
• CPC Class Codes: A61N 1/3688 configured for switching the pacing mode, e.g. from AAI to DDD
• CPC Class Codes: A61N 1/3702 Physiological parameters A61N1/365 takes precedence; evoked response A61N1/371

Abstract

A cardiac rhythm management device includes a dual chamber pacemaker, especially designed for treating congestive heart failure by pacing a plurality of sites. The device incorporates a program microcontroller which is operative to adjust the pacing mode and inter-site delay of the pacemaker so as to achieve optimum hemodynamic performance. Atrial cycle lengths measured during transient (immediate) time intervals following a change in the mode inter-site delay are signal processed and a determination can then be made as to which particular configuration yields the optimum performance. Performance is optimized when the patient is at rest and when the patient exercises so that a rate-adapted dynamic value of the optimum performance can be applied.

Claims

1. A method of optimizing the pacing mode and inter-site delay configuration of a dual chamber pacemaker of the type having means for sensing atrial depolarization events, means for sensing ventricular depolarization events and means for applying cardiac stimulating pulses selectively to the right, left or both ventricular chambers at a plurality of sites at predetermined delay intervals following detection of atrial depolarization events, comprising the steps of:

(a) determining a patient'"'"'s intrinsic AV delay;

(b) generating randomized list of configurations, each having a specific pacing mode and AV delay, said AV delay being a function of the intrinsic AV delay;

(c) measuring a selected cardiac performance parameter selected from a group indicative of the performance of a patient'"'"'s heart during multi-site pacing for a first number of beats to establish a baseline using a first setting comprising a first pacing mode and first inter-site delay interval;

(d) varying the setting in accordance with a configuration from step (b);

(e) measuring said parameter during pacing for a second number of beats;

(f) calculating and storing a performance parameter feature value obtained in steps (C) and (e);

(g) repeating steps (c)-(f) which define a trial until said randomizer list is exhausted;

(h) re-randomizing list of configurations in (b) a predetermined number of times (N) and repeating steps (c)-(g) for each randomization that each configuration is repeated for N trials;

(i) determining that data confirms that all configurations are valid and wherein any invalid configuration results in ending of the optimization and return of the pacemaker to permanent settings;

(j) determining an optimal inter-site delay interval and pacing mode configuration based on measurements of said parameter at said plurality of configuration, each having a plurality of trials; and

(k) setting the inter-site delays and pacing mode configuration of the pacemaker to the optimal inter-site delays and pacing mode configuration established in step (j).

2. A method as in claim 1 wherein said selected cardiac parameter is selected from the group consisting of ACL and VCL.

3. A method as in claim 1 wherein said selected cardiac parameter is ACL.

4. A method as in claim 3 further comprising the step of performing a successful washout prior to repeating a trial.

5. A method as in claim 3 wherein any abnormal beats detected anywhere in a trial invalidate that trial.

6. A method as in claim 1 wherein a configuration is determined to be valid if a majority of trials of that configuration are valid.

7. A method as in claim 6 wherein said successful washout must occur within a fixed time limit otherwise the optimization is ended and permanent mode settings are restored.

8. A method as in claim 1 further comprising the steps of:

(1) testing the validity of each trial immediately after it is conducted; and

(m) repeating an invalid trial once prior to conducting a different trial.

9. A method as in claim 1 further comprising the steps of:

(n) comparing the total number of cardiac cycles used in the optimization to a maximum allowable number and ending the optimization and restoring permanent mode settings if the number is exceeded.

10. A method as in claim 1 wherein the patient'"'"'s AV delay is determined by averaging the delay over a predetermined number of normal beats and wherein that must be accomplished within a predetermined tine limit or the optimization ended and permanent mode settings restored.

11. A method as in claim 1 wherein the selected parameter is ACL and wherein a candidate optimum configuration setting is obtained by the following steps:

(o) smoothing the array of ACLs parameter values;

(p) determining for all instances of each pacing mode and inter-site delay configuration the maximum value of the smoothed ACLs in a first interval beginning after a change to the first number of beats N₁ and ending after a change to the second number of beats N₂ and a minimum value of the smoothed ACLs in a second interval beginning a predetermined number of beats prior to a change from the N₂ beats to the N₁ beats and ending with the beat associated with the maximum value;

(q) computing a smoothed ACL feature as the difference between the maximum value and the minimum value;

(r) calculating the mean value of the smoothed ACL features computed in step (h) over the all valid instances for each pacing mode inter-site delay configuration and determining the configuration yielding the largest mean value;

(s) determining among the valid instances associated with the configuration yielding the largest mean value a median value and a maximum value of smoothed ACL features.

12. A method as in claim 11 and when the ratio of maximum value and the median value of smoothed ACL features is greater than or equal to the predetermined threshold value, repeating steps (r) and (s) after recalculating the mean of the instances of the configuration associated with the largest mean value of smoothed ACL features after removing the instance having the maximum value of smoothed ACL features from the instances and if after removing the instance having the maximum value of smoothed ACL features from the instances this results in its configuration having less than a majority of valid instances, ending the optimization and restoring permanent mode settings.

13. A method as in claim 12 wherein said candidate optimum configuration is the optimum and the pacemaker is set to operate in that configuration.

14. A method as in claim 1 wherein the selected parameter is ACL and the feature value is calculated by the steps of:

(t) smoothing the array of ACLs;

(u) determining from the smoothed array of ACLs a maximum value and a minimum value in a first predetermined interval measured in beats for each inter-site delay and pacing mode configuration;

(v) determining from the smoothed array a mean value of ACLs in a second predetermined interval measured in beats for each inter-site delay and pacing mode configuration;

(w) computing an absolute value of the difference between said maximum value and said mean value and computing an absolute value of the difference between said minimum value and said mean value;

(x) comparing the absolute value of the difference between the maximum value and the mean value with the absolute value of the difference between the minimum value and the mean value to determine which is the larger;

(y) setting the ACL feature value to the difference between the maximum value and the mean value when the absolute value of that difference is greater than the absolute value of the difference between the minimum value and the mean value and setting the ACL feature value to the difference between the minimum value and the mean value when the absolute value of the difference between the maximum value and the mean value is less than or equal to the absolute value of the difference between the minimum value and the mean value;

(z) calculating the mean value of the smoothed ACL features computed in step (h) over the N₃ instances for each pacing mode inter-site delay configuration and determining the configuration yielding the largest mean value; and

(aa) determining among the valid instances associated with the configuration yielding the largest mean value a median value and a maximum value of smoothed ACL features.

15. The method of claim 14 and when the ratio of maximum value and the median value of smoothed ACL features is greater than or equal to the predetermined threshold value, repeating steps (z) and (aa) after recalculating the mean of the instances of the configuration associated with the largest mean value of smoothed ACL features after removing the instance having the maximum value of smoothed ACL features from the instances and if after removing the instance having the maximum value of smoothed ACL features from the instances this results in its configuration having less than a majority of valid instances, ending the optimization and restoring permanent mode settings.

16. A method as in claim 1 wherein each configuration contains an AV delay in the range between 25% and 75% of intrinsic AV delay.

17. A method as in claim 1 wherein the selected parameter is VCL and wherein a candidate optimum configuration setting is obtained by the following steps:

(o) smoothing the array of VCLs parameter values;

(p) determining for all instances of each pacing mode and inter-site delay configuration the maximum value of the smoothed VCLs in a first interval beginning after a change to the first number of beats N₁ and ending after a change to the second number of beats N₂ and a minimum value of the smoothed VCLs in a second interval beginning a predetermined number of beats prior to a change from the N₂ beats to the N₁ beats and ending with the beat associated with the maximum value;

(q) computing a smoothed VCL feature as the difference between the maximum value and the minimum value;

(r) calculating the mean value of the smoothed VCL features computed in step (h) over the N₃ instances for each pacing mode inter-site delay configuration and determining the configuration yielding the largest mean value;

(s) determining among the valid instances associated with the configuration yielding the largest mean value a median value and a maximum value of smoothed VCL features.

18. A method as in claim 17 and when the ratio of maximum value and the median value of smoothed VCL features is greater than or equal to the predetermined threshold value, repeating steps (r) and (s) after recalculating the mean of the instances of the configuration associated with the largest mean value of smoothed VCL features after removing the instance having the maximum value of smoothed VCL features from the instances and if after removing the instance having the maximum value of smoothed VCL features from the instances this results in its configuration having less than a majority of valid instances, ending the optimization and restoring permanent mode settings.

19. A method as in claim 18 wherein said candidate optimum configuration is the optimum and the pacemaker is set to operate in that configuration.

20. A method as in claim 1 wherein the selected parameter is VCL and the feature value is calculated by the steps of:

(t) smoothing the array of VCLs;

(U) determining from the smoothed array of VCLs a maximum value and a minimum value in a first predetermined interval measured in beats for each inter-site delay and pacing mode configuration;

(v) determining from the smoothed array a mean value of VCLs in a second predetermined interval measured in beats for each inter-site delay and pacing mode configuration;

(w) computing an absolute value of the difference between said maximum value and said mean value and computing an absolute value of the difference between said minimum value and said mean value;

(x) comparing the absolute value of the difference between the maximum value and the mean value with the absolute value of the difference between the minimum value and the mean value to determine which is the larger;

(y) setting the VCL feature value to the difference between the maximum value and the mean value when the absolute value of that difference is greater than the absolute value of the difference between the minimum value and the mean value and setting the VCL feature value to the difference between the minimum value and the mean value when the absolute value of the difference between the maximum value and the mean value is less than or equal to the absolute value of the difference between the minimum value and the mean value;

(z) calculating the mean value of the smoothed VCL features computed in step (h) over the N₃ instances for each pacing mode inter-site delay configuration and determining the configuration yielding the largest mean value; and

(aa) determining among the valid instances associated with the configuration yielding the largest mean value a median value and a maximum value of smoothed VCL features.

21. The method of claim 20 and when the ratio of maximum value and the median value of smoothed VCL features is greater than or equal to the predetermined threshold value, repeating steps (z) and (aa) after recalculating the mean of the instances of the configuration associated with the largest mean value of smoothed VCL features after removing the instance having the maximum value of smoothed VCL features from the instances and if after removing the instance having the maximum value of smoothed VCL features from the instances this results in its configuration having less than a majority of valid instances, ending the optimization and restoring permanent mode settings.