Closed-loop control of cardioprotective pre-excitation pacing

• US 7,711,420 B2
• Filed: 03/19/2007
• Issued: 05/04/2010
• Est. Priority Date: 03/19/2007
• Status: Expired due to Fees

• Current Assignee: Cardiac Pacemakers Incorporated (Boston Scientific Corporation)
• Original Assignee: Cardiac Pacemakers Incorporated (Boston Scientific Corporation)
• Inventors: Baynham, Tamara Colette, Zhang, Yi, Cazares, Shelley M., Ni, Quan, Stalsberg, Kevin J.
• Primary Examiner(s): Manuel; George
• Assistant Examiner(s): Wieland; Robert N
• Application Number:
  US11/687,957
• Publication Number:
  US 20080234774A1
• Time in Patent Office: 1,142 Days
• Field of Search: 607/3, 607/9, 600/16, 600/18
• 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 1/36585 controlled by two or more physical parameters
• 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 1/3682 with a variable atrioventricular delay
• CPC Class Codes: A61N 1/3684 for stimulating the heart at multiple sites of the ventricle or the atrium
• CPC Class Codes: A61N 1/36842 Multi-site stimulation in the same chamber
• CPC Class Codes: A61N 1/36843 Bi-ventricular stimulation

Abstract

Cardioprotective pre-excitation pacing may be applied to stress or de-stress a particular myocardial region delivering of pacing pulses in a manner that causes a dyssynchronous contraction. Such dyssynchronous contractions are responsible for the desired cardioprotective effects of pre-excitation pacing but may also be hazardous. Described herein is a method and system that uses measures of ventricular dyssynchrony or a patient'"'"'s physiological response to ventricular dyssynchrony to control the delivery of cardioprotective pre-excitation pacing in closed-loop fashion.

Claims

1. A cardiac device, comprising:

one or more pacing channels for delivering pacing pulses to one or more myocardial sites;

a controller programmed to operate the device in either a normal operating mode or to deliver cardioprotective pacing in a cardioprotective mode;

wherein, in the cardioprotective mode, the controller is programmed to deliver paces to the one or more myocardial sites using a pacing mode that results in some degree of ventricular dyssynchrony as compared with the normal operating mode;

wherein the controller is programmed to periodically or intermittently switch from the normal operating mode to the cardioprotective mode according to exit and entry conditions;

a plurality of sensors for sensing physiological variables reflective of either the degree of ventricular dyssynchrony or a patient'"'"'s physiological response to the ventricular dyssynchrony produced by the cardioprotective pacing;

wherein the controller is programmed to compute a stress index as a function of one or more of the sensed physiological variables;

wherein the controller is programmed to compute a protective index as a function of one or more of the sensed physiological variables;

wherein the controller is programmed to modify one or more cardioprotection parameters that affect the amount of ventricular dyssynchrony produced by the cardioprotective pacing in a manner that tends to maintain the protective index at a specified desired protection level value; and

,

wherein the controller is programmed to compare the computed stress index with a specified stress limit range and to adjust the desired protection level value to decrease the amount of ventricular dyssynchrony produced by the cardioprotective pacing if the stress index is in the specified stress limit range.

2. The device of claim 1 wherein the one or more cardioprotection parameters affecting the amount of ventricular dyssynchrony produced by the cardioprotective pacing are selected from a group that includes the duty cycle of the cardioprotective mode, a pacing site or sites used in the cardioprotective mode, a pacing algorithm used in the cardioprotective mode, a pacing rate used in the cardioprotective mode, pacing amplitude, pacing pulse duration, pacing vector, pacing sequence of multiple pacing sites, VV delay(s) between multiple ventricular paces, and the value of an AV delay used in the cardioprotective mode.

3. The device of claim 1 wherein the protective index is computed as a function of one or more physiological variables selected from a group that includes a QRS width of an electrogram, QT interval of an electrogram, a time interval between electrically sensed contractions of different myocardial sites, a time interval between mechanically sensed contractions of different myocardial sites, the presence or absence of one or more particular heart sounds, cardiac output, cardiac wall motion, blood oxygen level, blood pH, heart rate variability, timing of myocardial impedance changes, and blood pressure.

4. The device of claim 1 wherein the stress index is computed as a function of one or more physiological variables selected from a group that includes a QRS width of an electrogram, QT interval of an electrogram, a time interval between electrically sensed contractions of different myocardial sites, a time interval between mechanically sensed contractions of different myocardial sites, the presence or absence of one or more particular heart sounds, cardiac output, cardiac wall motion, blood oxygen level, blood pH, heart rate variability, timing of myocardial impedance changes, and blood pressure.

5. The device of claim 1 wherein the controller is programmed to compute a separate parameter-specific protective index for adjusting each of a plurality of cardioprotection parameters in accordance therewith.

6. The device of claim 1 wherein the controller is programmed to map the deviation of the protective index from the desired protection level value to a plurality of cardioprotection parameters.

7. The device of claim 1 wherein the protective index and desired protection level values are vectors.

8. A method, comprising:

delivering pacing pulses to one or more myocardial sites in either a normal operating mode or in a cardioprotective mode;

wherein, in the cardioprotective mode, paces are delivered to the one or more myocardial sites using a pacing mode that results in some degree of ventricular dyssynchrony as compared with the normal operating mode;

periodically or intermittently switching from the normal operating mode to the cardioprotective mode according to exit and entry conditions;

sensing physiological variables reflective of either the degree of ventricular dyssynchrony or a patient'"'"'s physiological response to the ventricular dyssynchrony produced by the cardioprotective pacing;

computing a stress index as a function of one or more of the sensed physiological variables;

computing a protective index as a function of one or more of the sensed physiological variables;

modifying one or more cardioprotection parameters that affect the amount of ventricular dyssynchrony produced by the cardioprotective pacing in a manner that tends to maintain the protective index at a specified desired protection level value; and

,

comparing the computed stress index with a specified stress limit range and adjusting the desired protection level value to decrease the amount of ventricular dyssynchrony produced by the cardioprotective pacing if the stress index is in the specified stress limit range.

9. The method of claim 8 wherein the one or more cardioprotection parameters affecting the amount of ventricular dyssynchrony produced by the cardioprotective pacing are selected from a group that includes the duty cycle of the cardioprotective mode, a pacing site or sites used in the cardioprotective mode, a pacing algorithm used in the cardioprotective mode, a pacing rate used in the cardioprotective mode, pacing amplitude, pacing pulse duration, pacing vector, pacing sequence of multiple pacing sites, VV delay(s) between multiple ventricular paces, and the value of an AV delay used in the cardioprotective mode.

10. The method of claim 8 wherein the protective index is computed as a function of one or more physiological variables selected from a group that includes a QRS width of an electrogram, QT interval of an electrogram, a time interval between electrically sensed contractions of different myocardial sites, a time interval between mechanically sensed contractions of different myocardial sites, the presence or absence of one or more particular heart sounds, cardiac output, cardiac wall motion, blood oxygen level, blood pH, heart rate variability, timing of myocardial impedance changes, and blood pressure.

11. The method of claim 8 wherein the stress index is computed as a function of one or more physiological variables selected from a group that includes a QRS width of an electrogram, QT interval of an electrogram, a time interval between electrically sensed contractions of different myocardial sites, a time interval between mechanically sensed contractions of different myocardial sites, the presence or absence of one or more particular heart sounds, cardiac output, cardiac wall motion, blood oxygen level, blood pH, heart rate variability, timing of myocardial impedance changes, and blood pressure.

12. The method of claim 8 further comprising computing a separate parameter-specific protective index for adjusting each of a plurality of cardioprotection parameters in accordance therewith.

13. The method of claim 8 further comprising mapping the deviation of the protective index from the desired protection level value to a plurality of cardioprotection parameters.

14. The method of claim 8 wherein the protective index and the desired protection level value are vectors.

15. A system, comprising:

an implantable cardiac device having one or more pacing channels for delivering pacing pulses to one or more myocardial sites and a controller programmed to operate the device in either a normal operating mode or to deliver cardioprotective pacing in a cardioprotective mode;

wherein, in the cardioprotective mode, the controller is programmed to deliver paces to the one or more myocardial sites using a pacing mode that results in some degree of ventricular dyssynchrony as compared with the normal operating mode;

wherein the controller is programmed to periodically or intermittently switch from the normal operating mode to the cardioprotective mode according to exit and entry conditions;

a plurality of sensors for sensing physiological variables reflective of either the degree of ventricular dyssynchrony or a patient'"'"'s physiological response to the ventricular dyssynchrony produced by the cardioprotective pacing;

an external programmer in communication with the implantable device via telemetry;

wherein the external programmer is programmed to compute a stress index as a function of one or more of the sensed physiological variables;

wherein the external programmer is programmed to compute a protective index as a function of one or more of the sensed physiological variables;

wherein the external programmer is programmed to modify one or more cardioprotection parameters that affect the amount of ventricular dyssynchrony produced by the cardioprotective pacing in a manner that tends to maintain the protective index at a specified desired protection level value; and

,

wherein the external programmer is programmed to compare the computed stress index with a specified stress limit range and to adjust the desired protection level value to decrease the amount of ventricular dyssynchrony produced by the cardioprotective pacing if the stress index is in the specified stress limit range.

16. The system of claim 15 wherein the one or more cardioprotection parameters affecting the amount of ventricular dyssynchrony produced by the cardioprotective pacing are selected from a group that includes the duty cycle of the cardioprotective mode, a pacing site or sites used in the cardioprotective mode, a pacing algorithm used in the cardioprotective mode, a pacing rate used in the cardioprotective mode, pacing amplitude, pacing pulse duration, pacing vector, pacing sequence of multiple pacing sites, VV delay(s) between multiple ventricular paces, and the value of an AV delay used in the cardioprotective mode.

17. The system of claim 15 wherein the protective index is computed as a function of one or more physiological variables selected from a group that includes a QRS width of an electrogram, QT interval of an electrogram, a time interval between electrically sensed contractions of different myocardial sites, a time interval between mechanically sensed contractions of different myocardial sites, the presence or absence of one or more particular heart sounds, cardiac output, cardiac wall motion, blood oxygen level, blood pH, heart rate variability, timing of myocardial impedance changes, and blood pressure.

18. The system of claim 15 wherein the stress index is computed as a function of one or more physiological variables selected from a group that includes a QRS width of an electrogram, QT interval of an electrogram, a time interval between electrically sensed contractions of different myocardial sites, a time interval between mechanically sensed contractions of different myocardial sites, the presence or absence of one or more particular heart sounds, cardiac output, cardiac wall motion, blood oxygen level, blood pH, heart rate variability, timing of myocardial impedance changes, and blood pressure.

19. The system of claim 15 wherein the external programmer is programmed to compute a separate parameter-specific protective index for adjusting each of a plurality of cardioprotection parameters in accordance therewith.

20. The system of claim 15 wherein the external programmer is programmed to map the deviation of the protective index from the desired protection level value to a plurality of cardioprotection parameters.