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

• US 10,029,103 B2
• Filed: 07/16/2012
• Issued: 07/24/2018
• Est. Priority Date: 07/14/2011
• 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): Layno, Carl H
• Assistant Examiner(s): Morales, Jon Eric C
• Application Number:
  US14/131,868
• Publication Number:
  US 20140222099A1
• Time in Patent Office: 2,199 Days
• Field of Search: 607 25
• CPC Class Codes: A61B 5/366 Detecting abnormal QRS complex, e.g. widening
• CPC Class Codes: A61N 1/365 controlled by a physiological parameter, e.g. heart potential evoked response A61N1/371
• 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 system and method for cardiac resynchronization therapy (“CRT”) in which a model of baseline cardiac electrical activity, such as a model of global baseline cardiac electrical activity derived from various surface electrocardiograph (“ECG”) signals, is utilized to automatically adjust pacing control parameters of a cardiac implantable electrical device (“CIED”) are provided. The baseline model is compared to CRT response patterns using modified pacing control parameters in an iterative fashion, based on a patient-specific response pattern phenotype determination, until ventricular electrical asynchrony is minimized. The pacing control parameters resulting in the minimum ventricular electrical asynchrony are used to generate final control parameters for CRT.

Claims

1. 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) receiving intracardiac signals indicative of cardiac electrical activity in the patient'"'"'s heart, using electrodes in electrical communication with one of the CRM device and an external programmer, after delivery of electrical impulses to the heart;

b)comparing the received cardiac electrical activity signals with a baseline cardiac electrical activity to characterize ventricular activation patterns using a QRS hieroglyphic framework, the baseline cardiac electrical activity acquired, using electrocardiograph surface leads, before the delivery of electrical impulses to the heart;

c) determining an activation fusion response phenotype based on the comparison in step b), the activation fusion response phenotype corresponding with odds of increased ventricular activation wavefront fusion associated with improved ventricular pump function, the activation fusion response phenotype being differentiated into distinct mutually exclusive phenotypes, including a cancellation fusion response phenotype, an oblique fusion response phenotype, and a summation fusion response phenotype;

d) setting one or more pacing control parameters based on the activation fusion response phenotype determined in step c) and the comparison in step (b); and

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

2. The method as recited in claim 1 in which step b) includes identifying one or more QRS complex glyphs in the acquired cardiac electrical activity signals.

3. The method as recited in claim 2 in which step b) further includes comparing the identified QRS complex glyphs with corresponding QRS complex glyphs in the baseline cardiac electrical activity.

4. The method as recited in claim 1 in which step b) further includes comparing a QRS duration in the received cardiac electrical activity signals with a corresponding QRS duration in the baseline cardiac electrical activity.

5. The method as recited in claim 1 in which step c) includes setting at least one of an atrioventricular interval and a ventricular-ventricular interval.

6. The method as recited in claim 1 further comprising characterizing the received signals in step a) as a fusion wavefront comprising propagating wave patterns from multiple cardiac resynchronization therapy stimulation sites.

7. The method as recited in claim 6 further comprising characterizing patterns of wavefront interference in the fusion wavefront based on the propagating wave patterns.

8. The method as recited in claim 1 in which step d) includes setting the one or more pacing control parameters in attempt to change the activation fusion response phenotype when the summation fusion response phenotype is determined in step c).

9. The method as recited in claim 1 further comprising estimating odds of reverse remodeling during cardiac resynchronization therapy based on the comparison in step b) and the determination in step c).

10. The method as recited in claim 9 wherein estimating odds of reverse remodeling during cardiac resynchronization therapy is based on at least one cardiac resynchronization therapy stimulation site.

11. 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 intracardiac signals indicative of cardiac electrical activity in the heart;

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

a memory for storing;

pacing control parameters for the impulse delivery system, and

a baseline electrocardiograph electrical activity acquired, using electrocardiograph surface leads, before delivery of electrical impulses delivered to the heart by the impulse delivery system;

and

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

receive intracardiac signals after the delivery of electrical impulses;

compare the received intracardiac signals to the baseline electrocardiograph electrical activity to characterize ventricular activation patterns using a QRS hieroglyphic framework;

determine an activation fusion response phenotype based on the comparison, the activation fusion response phenotype corresponding with odds of increased ventricular activation wavefront fusion associated with improved ventricular pump function, the activation fusion response phenotype being differentiated into distinct mutually exclusive phenotypes, including a cancellation fusion response phenotype, an oblique fusion response phenotype, and a summation fusion response phenotype;

generate adjusted pacing control parameters based on the activation fusion response phenotype and the comparison of the received signals with the baseline electrocardiograph electrical activity; and

provide cardiac resynchronization therapy to the heart in accordance with the adjusted pacing control parameters.

12. The device of claim 11, wherein QRS complexes in each surface lead of the electrocardiograph are deconstructed into waveform elements, and wherein ventricular activation in each surface lead is characterized by QRS hieroglyphs.

13. The device of claim 12, wherein the processor is further configured to deconstruct the QRS complexes into four possible waveform elements:

R, S, Q, and QS.

14. The device of claim 13, wherein the processor is further configured to use amplitudes and durations of the waveform elements of the QRS complexes to characterize specific ventricular activation patterns.

15. The device of claim 14, wherein ventricular activation in each surface lead is characterized by nine possible QRS hieroglyphs:

a. R, when only R-wave is present;

b. RS, when R-wave and S-wave are present with equal amplitude;

c. Rs, when R-wave and S-wave are present, R-wave with greater amplitude;

d. rS, when R-wave and S-wave are present, S-wave with greater amplitude;

e. QS, when Q-wave and S-wave are present with equal amplitude;

f. qR, when Q-wave and R-wave are present, R-wave with greater amplitude;

g. QR, when Q-wave and R-wave are present with equal amplitude;

h. Qr, when Q-wave and R-wave are present, Q-wave with greater amplitude; and

i. QRS, when Q-wave, R-wave, and S-wave are all present.

16. The device of claim 15, wherein the processor is further configured to analyze amplitude, directionality, and time duration of component waveforms of the QRS hieroglyphs to quantify ventricular activation.

17. The device of claim 11, wherein the intracardiac signals serve as morphological surrogates for surface electrocardiograph measures of global cardiac electrical activity.

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

an input configured to be coupled to electrodes in electrical communication with the CRM device to receive intracardiac signals representing cardiac electrical activity in the patient'"'"'s heart;

an output configured to communicate operational control parameters to the CRM device; and

a processor configured to;

receive the intracardiac signals representing cardiac electrical activity after delivery of electrical impulses to the patient'"'"'s heart;

access baseline cardiac electrical activity information, the baseline cardiac electrical activity information acquired, using electrocardiograph surface leads, before the delivery of electrical impulses to the patient'"'"'s heart;

compare the intracardiac signals representing cardiac electrical activity with the baseline cardiac electrical activity to characterize ventricular activation patterns using a QRS hieroglyphic framework;

determine a patient-specific activation fusion response phenotype based on the comparison of the signals representing cardiac electrical activity with the baseline cardiac electrical activity, the activation fusion response phenotype corresponding with odds of increased ventricular activation wavefront fusion associated with improved ventricular pump function, the activation fusion response phenotype being differentiated into distinct mutually exclusive phenotypes, including a cancellation fusion response phenotype, an oblique fusion response phenotype, and a summation fusion response phenotype;

determine at least one adjusted operational control parameter for controlling pacing using the activation fusion response phenotype and the comparison; and

communicate the at least one adjusted operational control parameter to the CRM device to perform cardiac resynchronization therapy using the at least one adjusted operational control parameter.