HEART FAILURE PATIENTS STRATIFICATION

• US 20140031643A1
• Filed: 06/07/2013
• Published: 01/30/2014
• Est. Priority Date: 07/27/2012
• Status: Active Application

• Current Assignee: Cardiac Pacemakers Incorporated (Boston Scientific Corporation)
• Original Assignee: Cardiac Pacemakers Incorporated (Boston Scientific Corporation)
• Inventors: An, Qi, Averina, Viktoria A., Thakur, Pramodsingh Hirasingh, Sweeney, Robert J., Zhang, Yi
• Application Number:
  US13/912,541
• Publication Number:
  US 20140031643A1
• Time in Patent Office: Days
• US Class Current: 600/309
• 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 5/08 Detecting, measuring or recording devices for evaluating the respiratory organs A61B5/0205 takes precedence
• CPC Class Codes: A61B 5/14546 for measuring analytes not otherwise provided for, e.g. ions, cytochromes
• CPC Class Codes: A61B 5/318 Heart-related electrical modalities, e.g. electrocardiography [ECG]
• CPC Class Codes: A61B 5/349 Detecting specific parameters of the electrocardiograph cycle
• CPC Class Codes: A61B 5/6869 Heart
• 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 5/746 Alarms related to a physiological condition, e.g. details of setting alarm thresholds or avoiding false alarms alarms per se G08B
• CPC Class Codes: A61B 7/00 Instruments for auscultation
• CPC Class Codes: A61B 7/003 Detecting lung or respiration noise
• CPC Class Codes: G16H 40/63 for local operation
• CPC Class Codes: G16H 50/30 for calculating health indices; for individual health risk assessment
• CPC Class Codes: G16H 50/70 for mining of medical data, e.g. analysing previous cases of other patients

Abstract

A system, apparatus and method are provided to quantify a risk of worsening heart failure for subject using at least one physiological sensor circuit such as, for example, a heart sound sensor, a respiration sensor, a cardiac activity sensor, or other sensor circuit. A central tendency measurement of the at least one physiological sensor can be used to quantify the risk of worsening heart failure of the subject.

Claims

1. An apparatus comprising:

at least a first physiological sensor circuit configured to generate a first physiological signal that is representative of cardiovascular function of a subject;

a control circuit communicatively coupled to the first physiological sensor circuit, wherein the control circuit includes;

a signal processing circuit configured to;

determine a first physiological measurement using the first physiological sensor signal and determine a plurality of the first physiological measurements using a plurality of first physiological signals produced over a specified first time period; and

determine a central tendency measurement of the plurality of physiological measurements; and

a risk circuit configured to quantify a risk of worsening heart failure (WHF) for the subject using the determined central tendency measurement, including comparing the determined central tendency measurement to one or more criteria indicative of risk of WHF,

wherein the control circuit is configured to generate an indication of risk of WHF according to a comparison of the determined central tendency measurement to the one or more criteria indicative of risk of WHF.

2. The apparatus of claim 1,

wherein the first physiological sensor circuit is configured to generate a first physiological signal type, and

wherein the signal processing circuit is configured to:

generate a first central tendency signal using a plurality of signals of the first physiological sensor signal type obtained for a number of cardiac cycles; and

determine the first physiological measurement using the first central tendency signal.

3. The apparatus of claim 1, wherein the first time period includes a number of days.

4. The apparatus of claim 1,

wherein the first physiological sensor circuit includes a heart sound sensor circuit configured to generate a heart sound signal that is representative of mechanical activity of a heart of the subject,

wherein the signal processing circuit is configured to:

determine a measurement of post-S2 heart sound energy using the heart sound signal and a plurality of measurements of post-S2 heart sound energy using a plurality of heart sound signals; and

determine a central tendency measurement of post-S2 heart sound energy, and

wherein the risk circuit is configured to quantify the risk of WHF for the subject using the central tendency measurement of post-S2 heart sound energy.

5. The apparatus of claim 4, including:

a second physiological sensor circuit that includes a respiration sensor circuit configured to generate a respiration signal that is representative of respiration of the subject,

wherein the signal processing circuit is configured to;

determine a measurement of respiration rate using the respiration signal and a plurality of measurements of respiration rate using a plurality of respiration signals; and

determine a central tendency measurement of respiration rate; and

wherein the risk circuit is configured to quantify the risk of WHF for the subject using the central tendency measurement of respiration rate and the central tendency measurement of post-S2 heart sound energy.

6. The apparatus of claim 5,

wherein the signal processing circuit is configured to determine a variation in respiration rate using the plurality of measurements of respiration rate, and

wherein the risk circuit is configured to quantify the risk of WHF for the subject using the variation of the respiration rate and the central tendency measurement of post-S2 heart sound energy.

7. The apparatus of claim 4,

wherein the signal processing circuit is configured to:

determine a measurement of S3 heart sound energy using the heart sound signal and a plurality of measurements of S3 heart sound energy using a plurality of heart sound signals; and

determine a central tendency measurement of S3 heart sound energy, and

wherein the risk circuit is configured to quantify a risk of WHF for the subject using the central tendency measurement of S3 heart sound energy.

8. The apparatus of claim 1,

wherein the first physiological sensor circuit includes a heart sound sensor circuit configured to generate a heart sound signal that is representative of mechanical activity of a heart of the subject,

wherein the apparatus includes a second physiological sensor circuit that includes a respiration sensor circuit configured to generate a respiration signal that is representative of respiration of the subject, and a third physiological sensor circuit that includes a cardiac signal sensor circuit configured to generate a cardiac activity signal representative of electrical cardiac activity of the subject,

wherein the signal processing circuit is configured to:

determine at least one of a plurality of measurements of post-S2 heart sound energy using a plurality of heart sound signals or a plurality of measurements of respiration rate using a plurality of respiration signals;

generate at least one of a central tendency post-S2 heart sound energy measurement or a central tendency respiration rate measurement;

measure one or more time intervals between at least one fiducial feature in a cardiac activity signal and at least one fiducial feature in a heart sound signal and determine a plurality of measurements of the time intervals using a plurality of cardiac activity signals and heart sound signals; and

determine, using the plurality of measurements of the time intervals, at least one of a central tendency time interval or a central tendency of a ratio of time intervals,

wherein the risk circuit is configured to quantify a risk of WHF for the subject using the central tendency time interval and at least one of the central tendency post-S2 heart sound energy measurement or the central tendency respiration rate measurement.

9. The apparatus of claim 8, wherein the time intervals between the at least one fiducial feature in the cardiac activity signal and the at least one fiducial feature in the heart sound signal includes at least one of:

a time interval between an R-wave and an S1 heart sound;

a time interval between an Q-wave and an S1 heart sound;

a time interval between an R-wave and R-wave;

a time interval between an Q-wave and Q-wave;

a time interval between an S1 heart sound and an S2 heart sound;

a time interval between an R-wave and an S2 heart sound;

a time interval between an Q-wave and an S2 heart sound;

a time interval between a R-wave and a fiducial representative of opening of the aortic valve (Ao);

a time interval between a Q-wave and a fiducial representative of Ao;

or

a time interval between a fiducial feature representative of Ao and a fiducial feature representative of closing of the aortic valve (Ac).

10. The apparatus of claim 1, wherein the first physiological sensor circuit includes at least one of:

a heart sound sensor circuit configured to generate a heart sound signal that is representative of mechanical activation of a chamber of a heart of the subject;

a respiration sensor circuit configured to generate a respiration signal that is representative of respiration of the subject;

or

a cardiac signal sensor circuit configured to generate a cardiac signal representative of electrical cardiac activity of the subject.

11. The apparatus of claim 10,

wherein the apparatus includes a second physiological sensor circuit that includes a biomarker sensor circuit configured to generate a biomarker signal that is representative of a level of biomarker in the subject,

wherein the signal processing circuit is configured to:

determine at least one of a plurality of measurements of post-S2 heart sound energy using a plurality of heart sound signals, a plurality of measurements of respiration rate using a plurality of respiration signals, a plurality of measurements of a time interval between two fiducial features in a heart sound signal, a plurality of measurements of a time interval between two fiducial features in a cardiac activity signal, or a plurality of measurements of a time interval between a fiducial feature in a cardiac signal and a fiducial feature in a heart sound signal;

generate at least one of a central tendency post-S2 heart sound energy measurement, a central tendency respiration rate measurement, a central tendency measurement of a time interval between two fiducial features in a heart sound signal, a central tendency measurement of a time interval between two fiducial features in a cardiac activity signal, or a central tendency measurement of a time interval between a fiducial feature in a cardiac signal and a fiducial feature in a heart sound signal;

determine a plurality of indications of the level of biomarker in the subject using a plurality of biomarker signals; and

generate a central tendency of the indication of the biomarker level using the plurality of indications of the level of biomarker,

wherein the risk circuit is configured to quantify the risk of WHF for the subject using central tendency of the indication of the biomarker level and at least one of the central tendency post-S2 heart sound energy measurement, the central tendency respiration rate measurement, the central tendency measurement of a time interval between two fiducial features in a heart sound signal, the central tendency measurement of a time interval between two fiducial features in a cardiac activity signal, or the central tendency measurement of a time interval between a fiducial feature in a cardiac signal and a fiducial feature in a heart sound signal.

12. The apparatus of claim 11, wherein the biomarker sensor circuit is configured to generate a biomarker signal that is representative of at least one of:

a level of B-type Naturetic Peptide (BNP) in the subject;

or

a level of NT-Pro-BNP of the subject.

13. The apparatus of claim 1, wherein the risk circuit is configured to quantify the risk of WHF for the subject using the determined central tendency measurement and using historical data of HF admissions for the subject.

14. The apparatus of claim 1, wherein the risk circuit is configured to:

compare the determined central tendency measurement to a first threshold risk detection value; and

determine a risk index for WHF according to a frequency with which the determined central tendency measurement satisfies the first threshold risk detection value within a specified period of time, wherein the control circuit is configured to generate the alert according to the risk index.

15. The apparatus of claim 1,

wherein the criteria indicative of risk of WHF includes a first threshold risk detection value for the determined central tendency measurement, and

wherein the risk circuit is configured to adjust the first threshold risk detection value according to one or both of physiologic data and historical data of HF admissions for the subject.

16. The apparatus of claim 1, wherein the risk circuit is configured to recurrently quantify a risk of WHF for the subject and recurrently adjust the one or more criteria indicative of risk of WHF.

17. A method of operating an ambulatory medical device, the method comprising:

producing a first physiological sensor signal using a first physiological sensor of the ambulatory medical device, wherein a physiological sensor signal is representative of cardiovascular function of a subject;

determining a first physiological measurement using the first physiological sensor signal;

producing a plurality of the first physiological sensor signals over a specified first time period and determining a plurality of physiological measurements using the plurality of first physiological sensor signals;

determining a central tendency measurement of the plurality of physiological measurements;

quantifying a risk of WHF for the subject using the determined central tendency measurement, including comparing the determined central tendency measurement to one or more criteria indicative of risk of WHF; and

generating an indication of risk of WHF according to a comparison of the determined central tendency measurement to the one or more criteria indicative of risk of WHF.

18. The method of claim 17,

wherein producing a plurality of the first physiological sensor signals includes producing a plurality of heart sound signals, wherein a heart sound signal is representative of mechanical activity of a heart of the subject,

wherein determining a plurality of physiological measurements includes determining a plurality of measurements of post-S2 heart sound energy using the plurality of heart sound signals,

wherein determining a central tendency measurement includes determining a central tendency measurement of post-S2 heart sound energy, and

wherein quantifying a risk of WHF includes quantifying a risk of WHF for the subject using the central tendency measurement of post-S2 heart sound energy.

19. The method of claim 18, including:

producing a plurality of respiration signals using a respiration sensor circuit, wherein a respiration signal is representative of respiration of the subject;

determining a plurality of measurements of respiration rate using the plurality of respiration signals;

determining a central tendency measurement of respiration rate using the plurality of measurements of respiration rate, and

wherein quantifying the risk of WHF includes quantifying the risk of WHF for the subject using the central tendency measurement of post-S2 heart sound energy and the central tendency measurement of respiration rate.

20. The method of claim 19, including storing historical data of HF admissions for the subject, and wherein quantifying the risk of WHF includes quantifying the risk of WHF for the subject using the determined central tendency measurement and the historical data of HF admissions for the subject.