Heart Failure Decompensation Prediction Based on Cardiac Rhythm

• US 20090234410A1
• Filed: 03/11/2009
• Published: 09/17/2009
• Est. Priority Date: 03/12/2008
• Status: Active Grant

• Current Assignee: Medtronic Monitoring, Inc. (Medtronic Plc)
• Original Assignee: Corventis
• Inventors: Manicka, Yatheendhar D., Libbus, Imad, Mazar, Scott T., Amurthur, Badri
• Granted Patent: US 8,718,752 B2
• Time in Patent Office: Days
• US Class Current: 607/17
• CPC Class Codes: A61B 2560/0412 Low-profile patch shaped housings
• CPC Class Codes: A61B 5/0006 ECG or EEG signals
• CPC Class Codes: A61B 5/0022 Monitoring a patient using a global network, e.g. telephone networks, internet
• CPC Class Codes: A61B 5/0031 Implanted circuitry
• CPC Class Codes: A61B 5/0205 Simultaneously evaluating both cardiovascular conditions and different types of body conditions, e.g. heart and respiratory condition
• CPC Class Codes: A61B 5/02055 Simultaneously evaluating both cardiovascular condition and temperature
• CPC Class Codes: A61B 5/053 Measuring electrical impedance or conductance of a portion of the body
• CPC Class Codes: A61B 5/282 Holders for multiple electrodes for introduction into the body A61B5/287
• CPC Class Codes: A61B 5/361 Detecting fibrillation
• CPC Class Codes: A61B 5/363 Detecting tachycardia or bradycardia
• CPC Class Codes: A61B 5/6833 Adhesive patches
• CPC Class Codes: A61B 5/7246 using correlation, e.g. template matching or determination of similarity
• CPC Class Codes: A61B 5/7275 Determining trends in physiological measurement data; Predicting development of a medical condition based on physiological measurements, e.g. determining a risk factor
• CPC Class Codes: A61B 7/04 Electric stethoscopes microphones, acoustic transducers therefor H04R
• CPC Class Codes: G16H 50/20 for computer-aided diagnosis, e.g. based on medical expert systems
• CPC Class Codes: G16H 50/30 for calculating health indices; for individual health risk assessment

Abstract

Systems and methods of detecting an impending cardiac decompensation of a patient measure an electrocardiogram signal of the patient. An incidence of cardiac arrhythmias is determined from the electrocardiogram signal. A risk of impending decompensation is determined in response to the incidence of cardiac arrhythmias. In many embodiments, the impending decompensation can be detected early enough to avoid, or at least delay, the impending decompensation, such that patient trauma and/or expensive ICU care can be avoided. Although embodiments make specific reference to monitoring electrocardiogram and other physiological signals with an adherent patch, the system methods and devices are applicable to many applications in which physiological monitoring is used, for example wireless physiological monitoring with implanted sensors for extended periods.

Claims

1. A method of detecting an impending cardiac decompensation of a patient, the method comprising:

measuring an electrocardiogram signal of the patient;

determining an incidence of cardiac arrhythmias from the electrocardiogram signal; and

determining a risk of impending decompensation in response to the incidence of cardiac arrhythmias.

2. The method of claim 1 wherein the electrocardiogram signal is measured for at least one week and the risk of impending decompensation is determined in response to the incidence of cardiac arrhythmias measured for the at least one week.

3. The method of claim 1 wherein the incidence of cardiac arrhythmias is compared to an earlier baseline incidence of cardiac arrhythmias for the patient to determine the risk of impending decompensation.

4. The method of claim 1 wherein the incidence of cardiac arrhythmias is compared to an earlier baseline incidence of cardiac arrhythmias for a patient population to determine the risk of impending decompensation.

5. The method of claim 1 wherein the electrocardiogram signal comprises at least one of a derived signal, a time averaged signal, a filtered signal or a raw signal.

6. The method of claim 1 wherein the incidence of cardiac arrhythmias is combined with at least one of a heart rate, a heart rate variability, a bioimpedance, an activity or a respiration of the patient to determine the risk of impending decompensation.

7. The method of claim 6 wherein at least one of a weighted combination, a tiered combination or a logic gated combination, a time weighted combination or a rate of change is used to combine the incidence of cardiac arrhythmias with the at least one of the heart rate, the heart rate variability, the bioimpedance, the activity or the respiration of the patient.

8. The method of claim 1 wherein the incidence of cardiac arrhythmias is determined with an atrial arrhythmia comprising at least one of a bradycardia, an atrial fibrillation, an atrial tachycardia, or an atrial flutter.

9. The method of claim 1 wherein the incidence of cardiac arrhythmias is determined with a ventricular arrhythmia comprising at least one of a bradycardia, a sustained ventricular tachycardia, a non-sustained ventricular tachycardia or a premature ventricular contraction.

10. The method of claim 1 wherein the electrocardiogram signal is measured with an adherent patch comprising electrodes, the patch continuously adhered to the patient for at least one week.

11. The method of claim 1 wherein the electrocardiogram signal is measured with electrodes injected and/or implanted into the patient.

12. The method of claim 1 further comprising delivering a therapy to the patient in response to the risk of impending decompensation.

13. The method of claim 12 wherein the therapy comprises cardiac rhythm management therapy.

14. The method of claim 1 wherein the electrocardiogram signal is measured where the patient is located and the risk of impending decompensation is determined at a remote location.

15. The method of claim 14 wherein an adherent patch that supports a processor is adhered to the patient and the incidence of cardiac arrhythmias is determined with the processor when the patch is adhered to the patient, and wherein processor transmits the incidence of arrhythmias to the remote site to determine the risk of impending decompensation.

16. The method of claim 14 further comprising transmitting the electrocardiogram signal to an intermediate device to determine the incidence of arrhythmias and wherein the incidence of arrhythmias is transmitted from the intermediate device to the remote site where the risk of the impending cardiac decompensation is determined.

17. The method of claim 14 wherein the electrocardiogram signal is measured where the patient is located and the incidence of cardiac arrhythmias is determined at the remote site.

18. The method of claim 14 further comprising transmitting the electrocardiogram signal to an intermediate device to determine the incidence of arrhythmias and wherein the incidence of arrhythmias is transmitted from the intermediate device to the remote site where the risk of the impending cardiac decompensation is determined.

19. The method of claim 17 further comprising transmitting the electrocardiogram signal to the remote site where the risk of the impending cardiac decompensation is determined.

20. The method of claim 1 further comprising transmitting instructions from a remote site to a processor supported with the patient, and wherein the incidence of cardiac arrhythmias is determined with the processor in response to the instructions.

21. The method of claim 20 wherein the risk of impending decompensation is determined with the processor supported by the patient in response to the instructions from the remote site.

22. The method of claim 1 wherein a flag status is determined in response to the risk.

23. A system to detect impending cardiac decompensation of a patient, the system comprising:

circuitry to measure an electrocardiogram signal of the patient; and

a processor system comprising a tangible medium in communication with the circuitry, the processor system configured to determine an incidence of cardiac arrhythmias from the electrocardiogram signal and determine a risk of impending decompensation in response to the incidence of cardiac arrhythmias.

24. The system of claim 23 wherein the processor system is configured to receive the electrocardiogram signal for at least one week and determine the risk of impending decompensation in response to the incidence of cardiac arrhythmias over the at least one week.

25. The system of claim 23 wherein the processor system is configured to compare the incidence of cardiac arrhythmias to an earlier incidence of cardiac arrhythmias and determine the risk of impending decompensation.

26. The system of claim 23 wherein the electrocardiogram signal comprises at least one of a derived signal, a time averaged signal, a filtered signal or a raw signal.

27. The system of claim 23 wherein the processor system is configured to combine the incidence of cardiac arrhythmias with at least one of a heart rate, a heart rate variability, a bioimpedance, an activity or a respiration of the patient to determine the risk of impending decompensation.

28. The system of claim 23 further comprising an adherent patch comprising a breathable tape, electrodes and gel to measure the electrocardiogram signal, wherein the breathable tape, the electrodes and the gel are arranged to adhere continuously to the patient for at least one week and measure the electrocardiogram signal for the at least one week.

29. The system of claim 23 wherein the processor system is configured to determine the incidence of cardiac arrhythmias with an atrial arrhythmia comprising at least one of a bradycardia, an atrial fibrillation, an atrial tachycardia, or an atrial flutter.

30. The system of claim 23 wherein the processor system is configured to determine the incidence of cardiac arrhythmias with a ventricular arrhythmia comprising at least one of a bradycardia, a sustained ventricular tachycardia, a non-sustained ventricular tachycardia or a premature ventricular contraction.

31. The system of claim 23 further comprising electrodes coupled to the circuitry to measure the electrocardiogram signal, the electrodes configured to be implanted and/or injected into the patient.

32. The system of claim 23 wherein the processor system comprises a local processor and a remote processor at a remote site, the local processor connected to an adherent patch configured to adhere to the skin of the patient, the local processor configured to measure the electrocardiogram signal and wherein the remote processor is configured to determine the risk of impending decompensation.

33. The system of claim 32 wherein the local processor is configured to transmit the incidence of arrhythmias to the remote site and the remote processor is configured to determine the risk of impending decompensation.

34. The system of claim 32 wherein the local processor is configured to determine the incidence of cardiac arrhythmias in response to the electrocardiogram signal and wherein the remote processor is configured to determine the risk of impending decompensation in response to the incidence of electrocardiogram signals determined with the local processor.

35. The system of claim 32 wherein the remote processor is configured to determine the incidence of cardiac arrhythmias of the patient in response to the electrocardiogram signal.

36. The system of claim 35 wherein the local processor is configured to transmit the electrocardiogram signal to the remote site to determine the risk of impending decompensation.

37. The system of claim 23 wherein the processor system further comprises a local processor connected to an adherent patch configured to adhere to the skin of the patient, the local processor configured to determine the incidence of arrhythmias from the electrocardiogram signal and determine the risk of impending decompensation response to the incidence of arrhythmias.

38. The system of claim 37 wherein the local processor is configured to receive instructions transmitted from the remote site to configure the local processor to determine the risk of impending decompensation in response to the electrocardiogram signal.

39. The system of claim 23 wherein the processor system is configured to determine a flag status in response to the electrocardiogram signal.

40. A system to detect impending cardiac decompensation of a patient, the system comprising:

circuitry to measure an electrocardiogram signal of the patient; and

a processor system comprising a tangible medium in communication with the circuitry, the processor system configured to determining an incidence of cardiac arrhythmias from the electrocardiogram signal and determine a risk of impending decompensation in response to the incidence of cardiac arrhythmias.

41. A computer-readable storage medium comprising a set of instructions for a computer system to evaluate a risk of an impending cardiac decompensation of a patient, the set of instructions comprising:

an input routine operatively associated with a source of electrocardiogram data from the patient;

a run routine to determine a risk of the impending cardiac decompensation of the patient with the source of electrocardiogram data; and

an output routine providing the risk of the impending decompensation available for external use outside the computer system.

42. The computer readable storage medium of claim 41 wherein the input routine, the run routine and the output routine are located on a server at a remote site.