CARDIAC RISK STRATIFICATION UTILIZING BAROREFLEX SENSITIVITY MEASUREMENT

• US 20100113889A1
• Filed: 10/30/2008
• Published: 05/06/2010
• Est. Priority Date: 10/30/2008
• Status: Abandoned Application

• Current Assignee: Medtronic Incorporated (Medtronic Plc)
• Original Assignee: Medtronic Incorporated (Medtronic Plc)
• Inventors: Ghanem, Raja N.
• Application Number:
  US12/261,746
• Publication Number:
  US 20100113889A1
• Time in Patent Office: Days
• US Class Current: 600/301
• CPC Class Codes: A61B 5/02158 provided with two or more sensor elements
• CPC Class Codes: A61B 5/283 Invasive
• CPC Class Codes: A61B 5/29 for permanent or long-term implantation
• CPC Class Codes: A61B 5/352 Detecting R peaks, e.g. for synchronising diagnostic apparatus; Estimating R-R interval
• CPC Class Codes: A61N 1/36564 controlled by blood pressure
• CPC Class Codes: A61N 1/36585 controlled by two or more physical parameters
• CPC Class Codes: A61N 1/36592 controlled by the heart rate variability

Abstract

A monitoring or therapy system may obtain a baroreflex sensitivity (BRS) measurement via an implantable medical device (IMD). The monitoring or therapy system then may generate a risk stratification indicator based on the BRS measurement. In some examples, the IMD generates the risk stratification indicator, while in other examples, an external computing device, such as a programmer, generates the risk stratification indicator. The monitoring or therapy system also may obtain at least one of a heart rate variability (HRV) measurement and a non-sustained ventricular tachycardia (NSVT) indicator via the IMD, and may generate the risk stratification indicator based on the BRS measurement and one or both of the HRV measurement and the NSVT indicator. In some examples, the monitoring or therapy system may generate an instruction, indicator, or alert based on the risk stratification indicator. The indicator may indicate that the patient is a candidate for an implantable therapy device.

Claims

1. A method comprising:

obtaining a baroreflex sensitivity (BRS) measurement for a patient via an implantable medical device (IMD); and

generating a risk stratification indicator based on the BRS measurement, wherein the risk stratification indicator classifies the patient into one of a plurality of cardiac arrhythmia or cardiac mortality risk categories.

2. The method of claim 1, further comprising generating based on the risk stratification indicator an implantation indicator that indicates the patient is a candidate for implantation of an implantable therapy device.

3. The method of claim 2, wherein generating based on the risk stratification indicator the implantation indicator comprises generating an implantation indicator that indicates the patient is a candidate for an implantable cardioverter-defibrillator.

4. The method of claim 1, wherein generating the risk stratification indicator comprises generating the risk stratification indicator via at least one of the IMD and an external computing device.

5. The method of claim 1, wherein generating the risk stratification indicator comprises generating an indicator of at least one of low risk, medium risk, and high risk.

6. The method of claim 1, further comprising obtaining a heart rate variability (HRV) measurement via the IMD, and wherein generating the risk stratification indicator based on the BRS measurement comprises generating the risk stratification indicator based on the BRS measurement and the HRV measurement.

7. The method of claim 6, further comprising obtaining a non-sustained ventricular tachycardia (NSVT) measurement via the IMD, and wherein generating the risk stratification indicator based on the BRS measurement comprises generating the risk stratification indicator based on the BRS measurement, the HRV measurement, and the NSVT measurement.

8. The method of claim 1, further comprising obtaining a non-sustained ventricular tachycardia (NSVT) measurement via the IMD, and wherein generating the risk stratification indicator based on the BRS measurement comprises generating the risk stratification indicator based on the BRS measurement and the NSVT measurement.

9. The method of claim 1, wherein obtaining the BRS measurement via the IMD comprises:

determining an R−

R interval difference indicating a time between successive ventricular depolarizations;

determining a blood pressure difference; and

determining the BRS measurement based on the R−

R interval difference and the blood pressure difference.

10. The method of claim 9, wherein the blood pressure difference is a right ventricular blood pressure difference.

11. The method of claim 9, further comprising communicating the R−

R interval difference and the blood pressure difference to a computing device, wherein the computing device determines the BRS measurement based on the R−

R interval difference and the blood pressure difference.

12. An implantable medical device (IMD) comprising:

a measurement unit configured to obtain a baroreflex sensitivity (BRS) measurement for a patient; and

a processor that generates a risk stratification indicator based on the BRS measurement, wherein the risk stratification indicator classifies the patient into one of a plurality of cardiac arrhythmia or cardiac mortality risk categories.

13. The IMD of claim 12, wherein the processor generates based on the risk stratification indicator an implantation indicator that indicates the patient is a candidate for an implantable therapy device.

14. The IMD of claim 13, wherein the processor generates based on the risk stratification indicator an implantation indicator that indicates the patient is a candidate for an implantable cardioverter-defibrillator.

15. The IMD of claim 12, wherein the risk stratification indicator comprises an indicator of at least one of low risk, medium risk, and high risk of cardiac arrhythmia or cardiac mortality.

16. The IMD of claim 12, wherein the measurement unit comprises one or more electrodes that detect a cardiac signal and a pressure sensor and detects a blood pressure signal, and wherein the processor is configured to receive the cardiac signal and the blood pressure signal and determine the BRS measurement.

17. The IMD of claim 16, wherein the processor is further configured to determine a heart rate variability (HRV) measurement based on the cardiac signal and generate the risk stratification indicator based on the BRS measurement and the HRV measurement.

18. The IMD of claim 16, wherein the processor is further configured to determine a non-sustained ventricular tachycardia (NSVT) measurement based on the cardiac signal and generate the risk stratification indicator based on the BRS measurement and the NSVT measurement.

19. The IMD of claim 16, wherein the processor is configured to:

determine an R−

R interval difference indicating a time between successive ventricular depolarizations based on the cardiac signal;

determine a blood pressure difference based on the blood pressure signal; and

obtain the BRS measurement based on the R−

R interval difference and the blood pressure difference.

20. The IMD of claim 19, wherein the blood pressure difference is a right ventricular blood pressure difference.

21. The IMD of claim 12, further comprising a telemetry module, wherein the processor is configured to communicate the implantation indicator to an external device via the telemetry module.

22. A system comprising:

an implantable medical device (IMD) configured to obtain a baroreflex sensitivity (BRS) measurement for a patient; and

an external computing device that receives the BRS measurement from the IMD, generates a risk stratification indicator based on the BRS measurement, wherein the risk stratification indicator classifies the patient into one of a plurality of cardiac arrhythmia or cardiac mortality risk categories.

23. The system of claim 22, wherein the external computing device generates an implantation indicator based on the risk stratification indicator that indicates the patient is a candidate for an implantable therapy device.

24. The system of claim 23, wherein the external computing device generates based on the risk stratification indicator an implantation indicator that indicates the patient is a candidate for an implantable cardioverter-defibrillator.

25. The system of claim 22, wherein the risk stratification indicator comprises an indicator of at least one of low risk, medium risk, and high risk of cardiac arrhythmia or cardiac mortality.

26. The system of claim 22, wherein the IMD comprises one or more electrode, a pressure sensor, and a processor, wherein the processor senses a cardiac signal via the one or more electrode and a blood pressure signal via the pressure sensor, and wherein the processor determines the BRS measurement from the cardiac signal and the blood pressure signal.

27. The system of claim 26, wherein the processor is further configured to determine a heart rate variability (HRV) measurement based on the cardiac signal and transmit the HRV measurement to the external computing device via the telemetry module, and wherein the external computing device is configured to generate the risk stratification indicator based on the BRS measurement and the HRV measurement.

28. The system of claim 26, wherein the processor is further configured to determine a non-sustained ventricular tachycardia (NSVT) measurement based on the cardiac signal and transmit the NSVT measurement to the computing device via the telemetry module, and wherein the external computing device is configured to generate the risk stratification indicator based on the BRS measurement and the NSVT measurement.

29. The system of claim 26, wherein the processor is configured to:

determine an R−

R interval difference indicating a time between successive ventricular depolarizations based on the cardiac signal;

determine a blood pressure difference based on the blood pressure signal; and

determine the BRS measurement based on the R−

R interval difference and the blood pressure difference.

30. The system of claim 29, wherein the blood pressure difference is a right ventricular blood pressure difference.

31. The system of claim 22, wherein the IMD further comprises a telemetry module, and wherein the processor transmits the BRS measurement to the external computing device via the telemetry module.

32. A computer readable medium comprising instructions that cause a programmable processor to:

receive a cardiac signal of a patient and a blood pressure signal of the patient via a measurement unit of an implantable medical device (IMD);

determine a baroreflex sensitivity (BRS) measurement based on the cardiac signal and the blood pressure signal; and

generate a risk stratification indicator based on the BRS measurement, wherein the risk stratification indicator classifies the patient into one of a plurality of cardiac arrhythmia or cardiac mortality risk categories.

33. The computer readable medium of claim 32, wherein the instructions cause the processor to generate based on the risk stratification indicator an implantation indicator that indicates the patient is a candidate for an implantable therapy device.

34. The computer readable medium of claim 33, wherein the implantation indicator indicates the patient is a candidate for an implantable cardioverter-defibrillator.

35. The computer readable medium of claim 32, wherein the instructions that cause the programmable processor to obtain the BRS measurement comprise instructions that cause the programmable processor to:

determine an R−

R interval difference indicating a time between successive ventricular depolarizations based on the cardiac signal;

determine a blood pressure difference based on the blood pressure signal; and

determine the BRS measurement based on the R−

R interval difference and the blood pressure difference.

36. The computer-readable medium of claim 35, wherein the blood pressure difference is a right ventricular blood pressure difference.

37. An implantable medical device (IMD) comprising:

means for obtaining a baroreflex sensitivity (BRS) measurement for a patient; and

means for generating a risk stratification indicator based on the BRS measurement, wherein the risk stratification indicator classifies the patient into one of a plurality of cardiac arrhythmia or cardiac mortality risk categories.

38. The IMD of claim 37, further comprising means for generating based on the risk stratification indicator an implantation indicator that indicates the patient is a candidate for an implantable therapy device.

39. The IMD of claim 37, further comprising means for detecting a cardiac signal and means for detecting a blood pressure signal, and wherein the means for obtaining the BRS measurement determines the BRS measurement based on the cardiac signal and the blood pressure signal.

40. The system of claim 39, wherein the blood pressure signal is a right ventricular blood pressure signal.