System and method for tracking progression of left ventricular dysfunction using implantable cardiac stimulation device

• US 6,922,587 B2
• Filed: 06/26/2002
• Issued: 07/26/2005
• Est. Priority Date: 06/26/2002
• Status: Active Grant

• Current Assignee: Pacesetter Incorporated (Abbott Laboratories Incorporated)
• Original Assignee: Pacesetter Incorporated (Abbott Laboratories Incorporated)
• Inventors: Weinberg, Lisa P.
• Primary Examiner(s): Layno, Carl
• Application Number:
  US10/183,243
• Publication Number:
  US 20040002741A1
• Time in Patent Office: 1,126 Days
• Field of Search: 607/3, 607/9, 607/14, 607 16- 19, 607 23- 25, 600/509, 600/513, 600515-516
• US Class Current: 607/9
• CPC Class Codes: A61N 1/3622 comprising two or more electrodes co-operating with different heart regions
• CPC Class Codes: A61N 1/3627 for treating a mechanical deficiency of the heart, e.g. congestive heart failure or cardiomyopathy

Abstract

The progression or regression of left ventricular dysfunction (LVD) is automatically evaluated by a pacemaker or other implantable cardiac stimulation device by tracking changes in the resting sinus rate of the patient in which the device is implanted. The resting sinus rate is detected by first determining whether the patient is in a state of profound rest, such as sleep, then measuring the actual sinus rate during profound rest. Profound rest may be detected by using an activity variance sensor. An increase in the profound rest sinus rate over a period of several months indicates progression of LVD; whereas a decrease indicates regression. Appropriate LVD diagnostic information is recorded for subsequent review by a physician. Based on the progression or regression of LVD, the physician may then modify LVD drug therapy administered to the patient or may adjust control parameters of the pacemaker, such as overdrive pacing control parameters or control parameters affecting heart contractility via post-extrasystolic potentiation. If a drug pump is implanted within the patient for automatically delivering LVD drug therapy, the pacemaker controls the drug pump in view of any detected progression or regression of LVD. The technique may also be used to verify the efficacy of LVD drug therapy administered to the patient, whether delivered via an implanted drug pump or otherwise. Processing may be primarily performed within the implanted device itself or with an external programmer in communication with the implanted device. Activity state-based LVD tracking techniques are also set forth.

Claims

1. In an implantable cardiac stimulation device having a control unit, a sinus rate detector and a profound rest detector, a method for monitoring left ventricular dysfunction (LVD) within a patient, the method comprising:

detecting when the patient is in a state of profound rest using the profound rest detector;

measuring the sinus rate of the patient while the patient is in a state of profound rest using the sinus rate detector;

tracking changes in LVD, if any, within the patient using the control unit based on changes in the sinus rate measured while at profound rest; and

adjusting V—

V timing of bi-ventricular pacing in response to changes in LVD.

2. The method of claim 1 wherein the device includes a physiological sensor for detecting a diurnally-varying physiological parameter and wherein the profound rest detector determines whether the patient is in a state of profound rest based on signals received from the physiological sensor.

3. The method of claim 2 wherein the physiological sensor is selected from a group of diurnally-varying sensors including a body temperature sensor, pH sensor, a blood O₂ sensor, an activity variance sensor, a heart rate variance sensor, a stroke volume sensor, a QT interval sensor, a contractility sensor and a heart wall displacement sensor.

5. The method of claim 1 wherein the step of tracking changes in LVD include the steps of:

recording a baseline sinus rate detected while in an initial state of profound rest;

comparing the baseline rate with a subsequent sinus rate detected while in a subsequent state of profound rest; and

determining whether the subsequent rate is less than the baseline rate by a predetermined margin and, if so, generating a signal indicative of regression of LVD within the patient.

6. The method of claim 1 wherein the step of tracking changes in LVD include the steps of:

recording a baseline sinus rate detected while in an initial state of profound rest;

comparing the baseline rate with a subsequent sinus rate detected while in a subsequent state of profound rest; and

determining whether the subsequent rate is between predetermined upper and lower margins bracketing the baseline rate and, if so, generating a signal indicative of a lack of significant change in LVD within the patient.

7. The method of claim 1 wherein the implantable cardiac stimulation device includes a system for delivering cardiac therapy and wherein the method further includes the step of:

modifying therapy delivered to the patient based on changes, if any, in LVD.

8. The method of claim 7 wherein the device is capable of bi-ventricular pacing and single-site pacing and wherein the step of modifying therapy delivered to the patient includes the step of:

switching from single-site pacing to bi-ventricular pacing if progression in LVD is detected.

9. The method of claim 7 wherein the step of modifying therapy delivered to the patient includes the step of:

applying stimulus to alter heart contractility.

10. The method of claim 7 wherein the implantable cardiac stimulation device includes a drug dispensing device for delivering LVD drugs to the patient and wherein the step of modifying therapy delivered to the patient includes the step of:

controlling the drug dispensing device based on the changes, if any, in LVD.

11. The method of claim 1 further including the step of:

verifying LVD drug efficacy based on the changes, if any, in LVD.

12. The method of claim 11 wherein the step of verifying LVD drug efficacy include the steps of:

recording a baseline profound rest sinus rate detected while the patient is receiving LVD drugs;

comparing the baseline rate with a subsequent sinus rate detected while in a subsequent state of profound rest and while the patient is still receiving the dosage of LVD drugs; and

determining whether the subsequent rate is less than the baseline rate by a predetermined margin and, if so, generating a signal indicating that the LVD drugs have been effective.

13. The method of claim 1 wherein the implantable cardiac stimulation device includes a telemetry device for transmitting signals to an external device and wherein the method includes the additional step of:

transmitting signals representative of changes in LVD, if any, to the external device.

14. The method of claim 13 wherein the step of transmitting signals representative of changes in LVD, if any, includes the steps of:

transmitting values representative of sinus rates detected while in a state of profound rest as measured over the period of time.

4. In an implantable cardiac stimulation device having a control unit, a sinus rate detector and a profound rest detector, a method for monitoring left ventricular dysfunction (LVD) within a patient, the method comprising:

detecting when the patient is in a state of profound rest using the profound rest detector;

measuring the sinus rate of the patient while the patient is in a state of profound rest using the sinus rate detector;

tracking changes in LVD, if any, within the patient using the control unit based on changes in the sinus rate measured while at profound rest;

recording a baseline sinus rate detected while in an initial state of profound rest;

comparing the baseline rate with a subsequent sinus rate detected while in a subsequent state of profound rest; and

determining whether the subsequent sinus rate exceeds the baseline rate by a predetermined margin and, if so, generating a signal indicative of progression of LVD within the patient.

15. In an implantable cardiac stimulation device, a system for monitoring left ventricular dysfunction (LVD) within a patient comprising:

a profound rest detector operative to determine when the patient is in a state of profound rest;

a sinus rate detector operative to measure the sinus rate of the patient while the patient is in a state of profound rest;

an LVD tracking unit operative to track changes in LVD, if any, within the patient based on changes in the sinus rate measured while at profound rest; and

a controller adapted to adjust V—

V timing of bi-ventricular pacing in response to changes in LVD.

16. The system of claim 15 wherein the device includes a physiological sensor for detecting a diurnally-varying physiological parameter and wherein the profound rest detector is operative to determine whether the patient is in a state of profound rest based on signals received from the physiological sensor.

17. The system of claim 16 wherein the physiological sensor is selected from a group including a body temperature sensor, pH sensor, a blood O₂ sensor, an activity variance sensor, a heart rate variance sensor a stroke volume sensor, a QT interval sensor, a contractility sensor and a heart wall displacement sensor.

18. The system of claim 15 wherein the implantable cardiac stimulation device includes a system for delivering cardiac therapy and wherein the system for monitoring LVD is also operative to control therapy delivered to the patient based on changes, if any, in LVD.

19. The system of claim 18 wherein the implantable cardiac stimulation device includes a drug dispensing device for delivering LVD drugs to the patient and wherein the system for monitoring LVD is also operative to control the drug dispensing device based on the changes, if any, in LVD.

20. The system of claim 15 wherein the system for monitoring LVD is also operative to verify LVD drug efficacy based on the changes, if any, in LVD.

21. The system of claim 15 wherein the implantable cardiac stimulation device includes a telemetry device for transmitting signals to an external device and wherein the system for monitoring LVD is also operative to control the telemetry device to transmit signals representative of changes in LVD, if any, to the external device.

22. A system for monitoring left ventricular dysfunction (LVD) within a patient, the system comprising:

means for measuring the sinus rate of the patient while in a state of profound rest;

means for tracking changes in LVD, if any, within the patient based on changes in the sinus rate measured while at profound rest; and

means for adjusting V—

V timing of bi-ventricular pacing in response to chances in LVD.

23. A method for monitoring left ventricular dysfunction (LVD) within a patient, an implantable cardiac stimulation device performing a method comprising:

detecting when the patient is in a predetermined activity state;

measuring the sinus rate of the patient while the patient in the predetermined activity state; and

tracking changes in LVD, if any, within the patient based on changes in the sinus rate measured while in the predetermined activity state.

24. In an implantable cardiac stimulation device, a system for monitoring left ventricular dysfunction (LVD) within a patient comprising:

an activity detector operative to determine when the patient is in a predetermined activity state;

a sinus rate detector operative to measure the sinus rate of the patient while the patient is in the predetermined activity state; and

an LVD tracking unit operative to track changes in LVD, if any, within the patient based on changes in the sinus rate measured while in the predetermined activity state.