Risk stratification based heart failure detection algorithm

• US 9,968,266 B2
• Filed: 12/26/2012
• Issued: 05/15/2018
• Est. Priority Date: 12/27/2006
• Status: Active Grant

• Current Assignee: Cardiac Pacemakers Incorporated (Boston Scientific Corporation)
• Original Assignee: Cardiac Pacemakers Incorporated (Boston Scientific Corporation)
• Inventors: An, Qi, Thakur, Pramodsingh Hirasingh, Averina, Viktoria A., Zhang, Yi, Sweeney, Robert J.
• Primary Examiner(s): Sereboff, Neal
• Application Number:
  US13/726,786
• Publication Number:
  US 20130116578A1
• Time in Patent Office: 1,966 Days
• CPC Class Codes: A61B 5/0031 Implanted circuitry
• CPC Class Codes: A61B 5/02007 Evaluating blood vessel condition, e.g. elasticity, compliance
• 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 5/024 Detecting, measuring or recording pulse rate or heart rate A61B5/0205, A61B5/021 take precedence
• CPC Class Codes: A61B 5/0816 Measuring devices for examining respiratory frequency measuring frequency of electric signals G01R23/00
• CPC Class Codes: A61B 5/4842 Monitoring progression or stage of a disease
• 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: A61N 1/37282 characterised by communication with experts in remote locations using a network
• CPC Class Codes: G06Q 10/00 Administration; Management
• CPC Class Codes: G16H 40/63 for local operation
• 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
• CPC Class Codes: G16H 50/50 for simulation or modelling of medical disorders
• CPC Class Codes: G16Z 99/00 Subject matter not provided for in other main groups of this subclass

Abstract

A system comprises a risk analysis module and a worsening heart failure (WHF) detection module. The risk analysis module measures at least one first physiological parameter of a subject using a physiological sensor of an ambulatory medical device, and determines a heart failure (HF) risk score for the subject according to the at least one measured first physiological parameter. The HF risk score indicates susceptibility of the subject to experiencing a HF event. The WHF detection module measures at least one second physiological parameter of the subject using the same or different physiological sensor, and generates an indication of prediction that the subject will experience a WHF event when the at least one second physiological parameter satisfies a WHF detection algorithm. The risk analysis module adjusts generation of the indication by the WHF detection algorithm according to the determined HF risk score.

Claims

1. A system comprising:

one or more ambulatory medical devices, wherein a first ambulatory medical device includes a heart sound sensor configured to sense an S3 heart sound of a subject; and

a processor, wherein the processor includes;

a control module configured to;

detect worsening heart failure (WHF) for the subject using a WHF detection scheme, wherein the WHF detection scheme includes comparing one or more measured heart failure (HF) physiological parameter parameters to a WHF detection threshold; and

store, in the memory, an alert of prediction that the subject will experience a WHF event when the one or more measured HF physiological parameter satisfies the WHF detection scheme; and

a risk analysis module configured to;

measure a first physiological parameter of the sensed S3 heart sound, wherein the first physiological parameter is distinct from the one or more measured HF physiological parameter parameters;

determine a HF risk score for the subject according to the at least one measured first physiological parameter in response to detecting the change, and determine whether the HF risk score indicates high risk for WHF or low risk for WHF; and

adjust one or more of the WHF detection scheme threshold, a weighting of the one or more measured HF physiological parameters, or a number of the one or more measured HF parameters that are compared to the WHF detection threshold according to the determined HF risk score to increase sensitivity of the WHF detection scheme when high risk for WHF is indicated and increase specificity of the WHF detection scheme when low risk for WHF is indicated;

wherein the one or more measured HF physiological parameters includes at least one of heart rate (HR), respiration rate (RR), tidal volume (TV), intrathoracic impedance (ITTI), or one or more of heart sound (HS) timing or amplitude distinct from the measured first physiological parameter.

2. The system of claim 1, wherein the control module is configured to generate the indication of prediction of a WHF event when the HF physiological parameter satisfies at least one detection criterion of the WHF detection scheme, and wherein the risk analysis module is configured to adjust the at least one detection criterion of the WHF detection scheme according to the determined HF risk score.

3. The system of claim 2, wherein the risk analysis module is configured to continuously vary at least one parameter of the WHF detection scheme as a function of the at least one first physiological parameter measurement.

4. The system of claim 1, wherein the risk analysis module is configured to select a detection scheme as the WHF detection scheme from among a plurality of detection schemes according to the determined HF risk score.

5. The system of claim 1, including:

wherein an ambulatory medical device of the one or more ambulatory medical devices includes at least one of;

a respiration sensor and wherein the at least one first physiological parameter further includes a measured day-to-day variation in respiratory rate of the subject;

a cardiac signal sensing circuit and wherein the at least one first physiological parameter further includes a time interval measured between two fiducial features occurring in one or more cardiac cycles;

a biomarker sensor configured to generate an indication or a surrogate indication of a biomarker indicative of a WHF event, and wherein the at least one first physiological parameter further includes at least one of a direct measure or a surrogate measure of the biomarker;

a jugular vein distention (JVD) sensor configured to generate an indication of JVD or a surrogate indication of JVD and wherein the at least one first physiological parameter further includes a measurement representative of JVD; and

a counter circuit and a timer circuit, and wherein the at least one first physiological parameter further includes a number of HF events detected for the subject within a specified time window.

6. The system of claim 1, wherein the risk analysis module is configured to:

measure a plurality of physiological parameters that are distinct from the HF physiological parameter; and

determine the HF risk score using the plurality of physiological parameters.

7. The system of claim 6, including:

a scoring module configured to determine individual reliability scores for each of the plurality of physiological parameters, wherein a higher reliability score is assigned to a physiological parameter having a more consistent measurement; and

wherein the risk analysis module is configured to combine the individual HF risk scores according to the determined reliability scores to form a composite HF risk score.

8. The system of claim 7, wherein the scoring module is configured to discard a HF risk score for a physiological parameter measurement when a reliability score determined for the physiological parameter measurement falls below a specified reliability score threshold value.

9. The system of claim 1, including:

a user interface in electrical communication with the risk analysis module, wherein the risk analysis module is configured to;

receive an indication of severity of an HF condition of the subject via the user interface; and

determine the HF risk score according to the first physiological parameter measurement and the received indication of severity.

10. The system of claim 1, including:

the first ambulatory medical device, wherein the first ambulatory medical device performs the WHF detection scheme;

an external medical device, wherein the external medical device includes the risk analysis module and a communication module in electrical communication with the risk analysis module, wherein the communication module is configured to communicate information with the ambulatory medical device, and wherein the risk analysis module is configured to communicate an adjustment to the WHF detection scheme to the first ambulatory medical device.

11. The system of claim 1, wherein the control module is configured to adjust a device-based therapy when the measured HF physiological parameter satisfies the adjusted WHF detection scheme.

12. A method of operation of a medical device system, the method comprising:

sensing an S3 heart sound of a subject using a heart sound sensor of a first ambulatory medical device;

detecting worsening heart failure (WHF) for the subject using a WHF detection scheme, wherein the WHF detection scheme that compares one or more measured heart failure (HF) physiological parameter parameters to a WHF detection threshold;

measuring at least one a first physiological parameter of the sensed S3 heart sound of a subject using a physiological sensor of an ambulatory medical device, wherein the first S3 heart sound is distinct from the one or more measured HF parameters;

detecting a change in the at least one first physiological parameter that exceeds a specified parameter change value;

determining a heart failure (HF) risk score for the subject according to the measured at least one first physiological parameter in response to detecting the change, and determine whether the HF risk score indicates high risk for WHF or low risk for WHF;

adjusting, by the medical device system, one or more of the WHF detection scheme threshold, a weighting of the one or more measured HF physiological parameters, or a number of the one or more measured HF parameters that are compared to the WHF detection threshold according to a comparison of the determined HF risk score to a HF risk score threshold value to increase sensitivity of the WHF detection scheme when high risk for WHF is indicated and increase specificity of the WHF detection scheme when low risk for WHF is indicated; and

presenting, using a display, an alert of prediction that the subject will experience or is experiencing a WHF event when the HF physiological parameter satisfies the adjusted WHF detection scheme using the adjusted detection of WHF;

wherein the one or more measured HF physiological parameters includes at least one of heart rate (HR), respiration rate (RR), tidal volume (TV), intrathoracic impedance (ITTI), or one or more of heart sound (HS) timing or amplitude distinct from the measured first physiological parameter.

13. The method of claim 12, wherein the WHF event is predicted when the HF physiological parameter satisfies at least one detection criterion of the WHF detection scheme, and wherein adjusting the WHF detection scheme includes adjusting the at least one second physiological parameter detection criterion of the WHF detection scheme according to the determined HF risk score.

14. The method of claim 12, wherein adjusting the WHF detection scheme includes varying at least one WHF detection scheme parameter continuously as a function of the determined HF risk score.

15. The method of claim 12, wherein adjusting the WHF detection scheme includes selecting a detection scheme from a plurality of WHF detection schemes according to the determined HF risk score.

16. The method of claim 12, including assigning a HF risk category to the subject according to a comparison of the determined HF risk score with at least one risk score threshold.

17. The method of claim 12, wherein the at least one first physiological parameter includes amplitude of the S3 heart sound and at least one of:

a number of HF events experienced by the subject within a specified time window;

day-to-day variation of respiratory rate;

at least one of a direct measure or a surrogate measure of a biomarker indicative of a WHF event;

a time interval between two fiducial features occurring in one or more cardiac cycles; and

a measure of jugular vein distention (JVD).

18. The method of claim 12, including:

receiving an indication of severity of an HF condition of the subject into the ambulatory medical device via a user interface, and wherein determining a HF risk score of the subject includes determining the HF risk score according to the at least one first physiological parameter measurement and the received indication of severity.

19. The method of claim 12, including adjusting a therapy provided by the ambulatory medical device when the measured HF physiological parameter satisfies the adjusted WHF detection scheme.

20. A medical system comprising:

an ambulatory medical device including a heart sound sensor configured to receive a parameter related to an S3 heart sound of a patient;

a display; and

a processor including;

a control module configured to;

detect worsening heart failure (WHF) using a WHF detection scheme based on one or more heart failure (HF) physiological parameter parameters of the patient satisfying a WHF detection threshold; and

a risk analysis module configured to;

receive the parameter related to the S3 heart sound from the ambulatory medical device; and

determine a risk category for worsening heart failure (WHF) based on the parameter related to the S3 heart sound, including a high risk category for WHF and a low risk category for WHF;

re-determine the risk when detecting a change in the a parameter related to a S3 heart sound that exceeds a specified parameter change value;

wherein the control module is further configured to;

adjust the WHF detection scheme according to the re-determined determined risk category by changing one or more of the WHF detection criteria for the HF physiological parameter threshold, a weighting of the one or more measured HF physiological parameters, or a number of the one or more measured HF parameters that are compared to the WHF detection threshold to increase sensitivity of the WHF detection scheme when the high risk category for WHF is indicated and increase specificity of the WHF detection scheme when the low risk category for WHF is indicated;

receive a measure related to the HF physiological parameter of the patient from the ambulatory medical device; and

present, using the display, an alert that the subject will experience or is experiencing a WHF event when the HF physiological parameter satisfies using the adjusted detection of WHF detection scheme;

wherein the one or more measured HF physiological parameters includes at least one of heart rate (HR), respiration rate (RR), tidal volume (TV), intrathoracic impedance (ITTI), or one or more of heart sound (HS) timing or amplitude distinct from the measured first physiological parameter.