System and method for automated adjustment of cardiac resynchronization therapy control parameters

• US 9,265,951 B2
• Filed: 07/16/2010
• Issued: 02/23/2016
• Est. Priority Date: 02/12/2010
• Status: Active Grant

• Current Assignee: Brigham and Women's Hospital Incorporated
• Original Assignee: Brigham and Women's Hospital Incorporated
• Inventors: Sweeney, Michael O.
• Primary Examiner(s): VOORHEES, CATHERINE M
• Application Number:
  US13/577,968
• Publication Number:
  US 20120310297A1
• Time in Patent Office: 2,048 Days
• Field of Search: 607/14, 607 17- 18, 607/25, 607 27- 28
• US Class Current: 1/1
• CPC Class Codes: A61B 5/35 by template matching
• 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 1/368 comprising more than one electrode co-operating with different heart regions A61N1/3622, A61N1/3627 take precedence
• CPC Class Codes: A61N 1/3684 for stimulating the heart at multiple sites of the ventricle or the atrium
• CPC Class Codes: A61N 1/36843 Bi-ventricular stimulation

Abstract

A system and method for cardiac resynchronization therapy in which pacing control parameters are automatically adjusted by comparison of local electrograms acquired by a cardiac implantable electrical device with a model of cardiac electrical activity derived from surface-lead electrocardiograph measurements under baseline and paced conditions is provided. The adjusted pacing control parameters guarantee substantially maximum evidence of ventricular activation wavefront fusion while reducing the risk of compromising diastolic function. Atrioventricular intervals (AVIs] are measured and utilized to constrain the adjustment of pacing control parameters such that diastolic dysfunctions are not induced in the patient'"'"'s heart.

Claims

1. A cardiac implantable electrical device for delivering cardiac resynchronization therapy to a patient'"'"'s heart, the cardiac implantable electrical device comprising:

an input for receiving signals indicative of cardiac electrical activity in the heart;

an impulse delivery system for delivering electrical impulses to the heart in order to provide cardiac resynchronization therapy thereto;

a memory for storing pacing control parameters and a model of global cardiac electrical activity derived from surface electrocardiograph signals;

a processor in communication with the memory, the processor being configured to;

receive the received signals;

compare the received signals with the stored model of global cardiac electrical activity that is derived from surface-lead electrocardiogram (ECG) measurements, wherein the comparison is made using a morphological framework that characterizes the received signals as surrogates for ECG measures of global cardiac electrical activity by deconstructing the ECG measures into waveform elements that are combinable into morphological patterns that are compared with the received signals;

adjust the stored pacing control parameters based on the comparison of the received signals with the stored model of global cardiac electrical activity; and

communicate with the impulse delivery system to provide cardiac resynchronization therapy to the heart in accordance with the received at least one of the stored pacing control parameters and adjusted pacing control parameters.

2. The cardiac implantable electrical device as recited in claim 1 in which the processor is further configured to identify one or more QRS complex glyphs in the received signals.

3. The cardiac implantable electrical device as recited in claim 2 in which the processor is further configured to compare the identified QRS complex glyphs with corresponding QRS complex glyphs in the stored model of global cardiac electrical activity.

4. The cardiac implantable electrical device as recited in claim 1 in which the processor is further configured to identify evidence of a substantially maximum ventricular resynchronization from the comparison of the received signals with the stored model of global cardiac electrical activity and bypass the adjustment of the stored pacing control parameters upon identifying a substantially maximum ventricular resynchronization.

5. The cardiac implantable electrical device as recited in claim 1 in which the processor is further configured to determine a permissible range of atrioventricular interval values from the received signals and the model of global cardiac electrical activity, and to adjust the stored pacing control parameters using the determined permissible range of atrioventricular interval values so that a probability for diastolic dysfunction is minimized.

6. The cardiac implantable electrical device as recited in claim 1 in which the processor is further in communication with the input and the processor is further configured to adjust an atrial sensitivity of the input, the atrial sensitivity being adjusted to maintain substantially synchronous ventricular activation while minimizing a probability of diastolic dysfunction.

7. The cardiac implantable electrical device as recited in claim 1 in which the model of global cardiac electrical activity is patient-specific and derived from surface-lead ECG signals acquired during a baseline and a paced condition.

8. A method for delivering cardiac resynchronization therapy to a patient'"'"'s heart with a cardiac rhythm management (CRM) device, the steps of the method comprising:

a) acquiring signals representing cardiac electrical activity in the patient'"'"'s heart using electrodes in electrical communication with the CRM device;

b) comparing the acquired cardiac electrical activity signals with a model of cardiac electrical activity that is derived from surface-lead electrocardiogram (ECG) measurements using a morphological framework that characterizes the signals acquired in step a) as surrogates for ECG measures of global cardiac electrical activity by deconstructing the ECG measures into waveform elements that are combinable into morphological patterns that are compared with the received signals; and

c) setting one or more pacing control parameters based on the comparison between the acquired cardiac electrical activity signals and the model of cardiac electrical activity; and

d) delivering cardiac resynchronization therapy to the patient'"'"'s heart using the one or more pacing control parameters.

9. The method as recited in claim 8 in which step b) includes identifying one or more QRS complex glyphs in the acquired cardiac electrical activity signals.

10. The method as recited in claim 9 in which step b) further includes comparing the identified QRS complex glyphs with corresponding QRS complex glyphs in the model of cardiac electrical activity.

11. The method as recited in claim 10 in which steps a)-c) are repeatedly performed while continually adjusting the one or more pacing control parameters until evidence of substantially maximum ventricular resynchronization is identified.

12. The method as recited in claim 11 in which the evidence of substantially maximum ventricular resynchronization is identified in step c) by comparing the acquired cardiac electrical activity signals with the model of cardiac electrical activity.

13. The method as recited in claim 8 in which the model of cardiac electrical activity utilized in step b) includes information related to baseline global cardiac electrical activity and paced global cardiac electrical activity during ventricular activation.

14. The method as recited in claim 13 in which the model of cardiac electrical activity utilized in step b) further includes information related to global cardiac electrical activity timing metrics including ventricular activation times and atrioventricular intervals.

15. The method as recited in claim 8 in which step c) includes setting at least one of an atrioventricular interval, a ventricular-ventricular interval, and a pacing stimulus output voltage.

16. The method as recited in claim 8 in which step c) includes determining a permissible range of atrioventricular interval values and setting the one or more pacing control parameters using the determined permissible range of atrioventricular interval values so that a probability for diastolic dysfunction is minimized.

17. The method as recited in claim 8 in which the one or more pacing control parameters includes an atrial sensitivity and step c) includes setting the atrial sensitivity such that substantially synchronous ventricular activation is maintained and a probability of diastolic dysfunction if minimized.

18. The method as recited in claim 8 further comprising:

e) calculating a probability of reverse ventricular remodeling using the model of cardiac electrical activity and the acquired signals; and

f) producing a report indicating the probability of reverse ventricular remodeling for cardiac resynchronization therapy using the one or more pacing control parameters.

19. The method as recited in claim 18 in which step e) includes performing a regression analysis using at least a QRS score, a left ventricular activation time, a mean change in an R-wave amplitude value;

and information related to a frontal place axis shift.