System and method for evaluating heart failure based on ventricular end-diastolic volume using an implantable medical device

• US 7,505,814 B2
• Filed: 03/26/2004
• Issued: 03/17/2009
• Est. Priority Date: 03/26/2004
• Status: Active Grant

• Current Assignee: Pacesetter Incorporated (Abbott Laboratories Incorporated)
• Original Assignee: Pacesetter Incorporated (Abbott Laboratories Incorporated)
• Inventors: Bornzin, Gene A., Park, Euljoon
• Primary Examiner(s): Layno; Carl H
• Assistant Examiner(s): SARCIONE, JESSICA LYNN
• Application Number:
  US10/810,437
• Publication Number:
  US 20050215914A1
• Time in Patent Office: 1,817 Days
• Field of Search: 607 4- 6, 607/9, 607 17- 18, 607 24- 25, 600508-509, 600/513, 600/521, 600/526, 600/547
• US Class Current: 607/17
• CPC Class Codes: A61B 5/02028 Determining haemodynamic parameters not otherwise provided for, e.g. cardiac contractility or left ventricular ejection fraction
• CPC Class Codes: A61B 5/0215 by means inserted into the body catheters A61M25/00
• CPC Class Codes: A61B 5/053 Measuring electrical impedance or conductance of a portion of the body
• CPC Class Codes: A61B 5/0538 invasively, e.g. using a catheter
• CPC Class Codes: A61B 5/287 Holders for multiple electrodes, e.g. electrode catheters for electrophysiological study [EPS]
• CPC Class Codes: A61B 5/363 Detecting tachycardia or bradycardia
• CPC Class Codes: A61B 5/4839 combined with drug delivery
• CPC Class Codes: A61B 5/7207 of noise induced by motion artifacts
• 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 1/36521 the parameter being derived from measurement of an electrical impedance

Abstract

Briefly, values representative of ventricular end-diastolic volume (EDV) are detected using ventricular electrodes and then heart failure, if occurring within the patient, is evaluated based on ventricular EDV. In this manner, ventricular EDV is used as a proxy for ventricular end-diastolic pressure. By using ventricular EDV instead of ventricular end-diastolic pressure, heart failure is detected and evaluated without requiring sophisticated sensors or complex algorithms. Instead, ventricular EDV is easily and reliably measured using impedance signals sensed by implanted ventricular pacing/sensing electrodes. The severity of heart failure is also evaluated based on ventricular EDV values and heart failure progression is tracked based on changes, if any, in ventricular EDV values over time.

Claims

1. A system for evaluating progression of heart failure within a patient using an implantable medical device, comprising:

a ventricular end-diastolic volume (EDV) detection unit for detecting values representative of ventricular EDV;

wherein the system is coupled to at least two electrodes configured for implant within the patient'"'"'s ventricles and wherein the EDV detection unit is adapted to;

(i.) identify a baseline point in time within each of a plurality of cardiac cycles for detecting the values representative of ventricular EDV, wherein the baseline point in time within each of the plurality of cardiac cycles is identified by tracking a pre-ejection interval and then selecting a point in time within the pre-ejection interval;

(ii.) detect a signal representative of an impedance between the two ventricular electrodes at each baseline point in time; and

(iii.) determine a baseline ventricular EDV value based on the impedance signal detected at each baseline point in time; and

wherein the system further comprises a ventricular EDV-based heart failure evaluation unit operative to detect progression of heart failure within the patient based on detecting changes, if any, over time in the baseline ventricular EDV values.

2. The system of claim 1 and further comprising:

a heart failure therapy controller that is responsive to detection of a progression of heart failure by the heart failure evaluation unit to adjust one or more operating parameters.

3. The system of claim 2 wherein the heart failure therapy controller is further adapted to deliver cardiac resynchronization therapy (CRT) to the heart of the patient.

4. The system of claim 1 and further comprising:

an implantable drug pump in communication with the heart failure evaluation unit and responsive to detection of a progression of heart failure by the heart failure evaluation unit to administer a drug.

5. The system of claim 1 and further comprising:

an implantable heart failure warning device in communication with the heart failure evaluation unit and responsive to detection of a progression of heart failure by the heart failure evaluation unit to generate a warning.

6. The system of claim 1 wherein the EDV detection unit is further adapted to detect the values representative of ventricular EDV during a ventricular pacing pulse.

7. The system of claim 1 wherein the heart failure evaluation unit is further adapted to detect heart failure by comparing the values representative of the ventricular EDV of the patient against a threshold ventricular EDV value indicative of heart failure.

8. The system of claim 1 wherein the heart failure evaluation unit is further adapted to evaluate the severity in heart failure, if present, within the patient based on the values representative of ventricular EDV.

9. The system of claim 8 wherein the heart failure evaluation unit is adapted to evaluate the severity in heart failure by comparing the values representative of the ventricular EDV of the patient against various threshold ventricular EDV values indicative of various degrees of heart failure.

10. The system of claim 1 wherein the heart failure evaluation unit is further adapted to detect changes in heart failure within the patient based on determining changes, if any, over time in the values representative of ventricular EDV.

11. The system of claim 10 wherein the heart failure evaluation unit is further adapted to detect changes in heart failure by comparing the values representative of ventricular EDV detected over an extended period of time.

12. The system of claim 11 wherein the heart failure evaluation unit is further adapted to compare values representative of ventricular EDV detected over a period of at least one month.

13. The system of claim 1 wherein the EDV detection unit is further adapted to detect values representative of ventricular EDV by:

tracking at least one respiration cycle;

detecting values representative of ventricular EDV at like baseline points within a plurality of cardiac cycles during the respiration cycle; and

processing the values representative of ventricular EDV over at least one respiration cycle to generate an average ventricular EDV value.

14. The system of claim 13 wherein the EDV detection unit is further adapted to process the values by averaging the values.

15. The system of claim 13 wherein the EDV detection unit is further adapted to average the values over many cardiac cycles to reduce respiratory variation of the EDV value.

16. The system of claim 1 wherein the EDV detection unit is adapted to detect a signal representative of impedance by delivering a detection pulse to the ventricles using the ventricular electrodes at the baseline point and sensing ventricular impedance based on the detection pulse using the ventricular electrodes.

17. The system of claim 16 wherein the EDV detection unit is adapted to select an amplitude of the detection pulse to be sufficiently low to avoid triggering myocardial depolarization.

18. The system of claim 1 wherein the EDV detection unit is adapted to track the pre-ejection interval by:

identifying a ventricular depolarization event; and

identifying a window 10-50 milliseconds (msecs) following the ventricular depolarization event.

19. The system of claim 1 wherein the EDV detection unit is additionally adapted to detect values representative of passive filling volume by:

identifying a baseline point within a cardiac cycle for detecting the value representative of passive filling volume;

detecting a signal representative of the impedance between the two ventricular electrodes at each baseline point in time; and

determining a baseline passive filling volume value based on the impedance signal detected at each baseline point in time.

20. The system of claim 19 wherein the EDV detection unit is adapted to identify the baseline point within the cardiac cycle for detecting the value representative of passive filling volume by:

tracking atrial depolarization to ventricular depolarization intervals during cardiac cycles;

predicting a next expected atrial depolarization based upon the atrial depolarization to ventricular depolarization intervals; and

identifying a window 10-50 milliseconds (msecs) prior to a next expected atrial depolarization.

21. The system of claim 20 wherein the EDV detection unit is adapted to identify the baseline point within the cardiac cycle for detecting the value representative of passive filling volume by identifying the time for delivery of a ventricular pacing pulse.

22. The system of claim 21 wherein the EDV detection unit is adapted to detect the signal representative of the impedance by:

delivering the ventricular pacing pulse using the ventricular electrodes; and

sensing ventricular impedance based upon the ventricular pacing pulse using the ventricular electrodes.

23. A system for tracking progression of heart failure within a patient using an implantable medical device, comprising:

means for determining ventricular end-diastolic volume (EDV) values;

wherein the means for determining ventricular EDV values is coupled to at least two electrodes configured for implant within the patient'"'"'s ventricles and comprises;

(i.) means for identifying a baseline point in time within each of a plurality of cardiac cycles for detecting the ventricular EDV values, wherein the baseline point in time within each of the plurality of cardiac cycles is identified by tracking a pre-ejection interval and then selecting a point in time within the pre-ejection interval;

(ii.) means for detecting a signal representative of an impedance between the at least two ventricular electrodes at each baseline point in time; and

(iii.) means for determining a baseline ventricular EDV values based on the impedance signal detected at each baseline point in time; and

wherein the system further comprises means for tracking progression of heart failure, if any, within the patient based on detecting changes, if any, over time in the baseline ventricular EDV values.

24. The system of claim 23 and further comprising:

means for controlling delivery of therapy based on progression of heart failure with the patient.

25. The system of claim 23 and further comprising:

means for administering a drug based on progression of heart failure with the patient.

26. The system of claim 23 and further comprising:

means for generating a warning based on progression of heart failure within the patient.