Integrating device-based sensors and bedside biomarker assays to detect worsening heart failure

• US 8,602,996 B2
• Filed: 05/31/2011
• Issued: 12/10/2013
• Est. Priority Date: 06/01/2010
• Status: Active Grant

• Current Assignee: Cardiac Pacemakers Incorporated (Boston Scientific Corporation)
• Original Assignee: Cardiac Pacemakers Incorporated (Boston Scientific Corporation)
• Inventors: Thakur, Pramodsingh Hirasingh, Patangay, Abhilash, Stolen, Craig, Meyer, Timothy
• Primary Examiner(s): Heller, Tammie K
• Application Number:
  US13/118,932
• Publication Number:
  US 20110295084A1
• Time in Patent Office: 924 Days
• Field of Search: 600/301, 600/509, 600/483, 435/7.1
• US Class Current: 600/483
• CPC Class Codes: A61B 2505/07 Home care
• 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 5/02 Detecting, measuring or recording pulse, heart rate, blood pressure or blood flow; Combined pulse/heart-rate/blood pressure determination; Evaluating a cardiovascular condition not otherwise provided for, e.g. using combinations of techniques provided for in this group with electrocardiography or electroauscultation; Heart catheters for measuring blood pressure
• 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 7/00 Instruments for auscultation
• CPC Class Codes: A61B 7/04 Electric stethoscopes microphones, acoustic transducers therefor H04R
• 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
• CPC Class Codes: A61N 1/3702 Physiological parameters A61N1/365 takes precedence; evoked response A61N1/371
• CPC Class Codes: A61N 1/37258 Alerting the patient

Abstract

Devices and methods for improving the sensitivity and specificity of heart failure (HF) detection are described. The devices and methods can detect a HF status such as using physiological sensor data and external biomarker assays. An apparatus can comprise ambulatory physiological sensors that can provide a first HF status indicator and a second HF status indicator to a user. An external biomarker sensor can provide an amount of a biomarker present, such as an assay for B-type natriuretic peptide (BNP), which provides information about HF status. A processor circuit can switch from a first HF detection mode to a second detection mode such as in response to the information from the biomarker sensor. The first detection mode can detect HF status using the first HF status indicator, and the second detection mode can detect HF status using the second HF status indicator. The second detection mode can have a higher specificity than the first detection mode.

Claims

1. An apparatus comprising:

two or more ambulatory physiological sensors configured to provide, to a user or automated process, a first heart failure status indicator using a first sensor selected from the two or more ambulatory physiological sensors and a second heart failure status indicator using a second sensor selected from the two or more ambulatory physiological sensors, the second sensor different from the first sensor;

an external biomarker sensor, configured to provide information to the user or automated process about an amount of a biomarker present in a biological substance, wherein the amount of the biomarker present provides information about heart failure status; and

a processor circuit, communicatively coupled to the at least one ambulatory physiological sensor and the external biomarker sensor, the processor configured to switch, in response to information from the biomarker sensor, from a first heart failure status detection mode detecting heart failure status using the first heart failure status indicator to a second heart failure status detection mode detecting heart failure status using a change over time in the second heart failure status indicator, the second heart failure status detection mode different from and having a higher specificity than the first heart failure status detection mode.

2. The apparatus of claim 1, wherein the processor is configured to use the amount of the biomarker present to adjust a specified threshold value of the second heart failure status indicator.

3. The apparatus of claim 1, wherein the processor is configured to use the amount of the biomarker present to adjust a specified threshold value of at least one of the first or second heart failure status indicators.

4. The apparatus of claim 1, wherein the physiological sensor includes at least one of a respiration sensor or a thoracic fluid sensor, and wherein the first heart failure status indicator includes at least one of a measure of respiration or a measure of thoracic fluid.

5. The apparatus of claim 1, wherein the physiological sensor includes a heart sound sensor, and wherein the second heart failure status indicator includes a measure of a S3 heart sound.

6. The apparatus of claim 1, wherein the biomarker includes at least one of BNP, NT-proBNP, ANP, MR-proANP, adrenomedullin, ST2, serum sodium, copeptin, CT-proET-1, adiponectin, 15 chromogranin A, proguanylin, prouroguanylin, hsTropinin-I, Corin, Urotensin, IL-6, hsCRP, miR423-5p, miRl29-5p, miR1254, HS_—

202.1, and miR622.

7. The apparatus of claim 1, wherein the processor is configured to switch from the first heart failure status detection mode to the higher specificity second heart failure status detection mode when the amount of biomarker present is within a specified threshold range.

8. The apparatus of claim 1, wherein the processor, when in the first heart failure status detection mode, is configured to use information about the first heart failure status indicator and the amount of biomarker present to provide information about heart failure status.

9. The apparatus of claim 8, wherein, the processor, when in the first heart failure status detection mode, is configured to provide an alert to the user or automated process when the amount of biomarker present exceeds a specified threshold value.

10. The apparatus of claim 1, wherein the processor, when in the second heart failure status detection mode, is configured to use information about the first heart failure status indicator, the amount of biomarker present, and a change over time in the second heart failure status indicator to provide information about heart failure status.

11. The apparatus of claim 10, wherein the processor, when in the second heart failure status detection mode, is configured to provide an alert to the a user or automated process when the second heart failure status indicator exceeds a specified threshold value.

12. The apparatus of claim 1, wherein the second heart failure status indicator includes an integration of measures from multiple physiological sensors.

13. A method comprising:

using at least one two or more ambulatory physiological sensors for providing a first heart failure status indicator using a first sensor selected from the two or more ambulatory physiological sensors and a second heart failure status indicator using a second sensor selected from the two or more ambulatory physiological sensors, the second sensor different from the first sensor;

using an external biomarker sensor, detecting an amount of a biomarker present in a biological substance to provide information about heart failure status;

using information about the amount of biomarker present, switching from a first heart failure status detection mode detecting heart failure status using the first heart failure status indicator to a second heart failure status detection mode detecting heart failure status using a change over time in the second heart failure status indicator, the second heart failure status detection mode different from and having a higher specificity than the first heart failure status detection mode.

14. The method of claim 13, comprising using the amount of the biomarker present to adjust a specified threshold value of at least one of the first or second heart failure status indicators.

15. The method of claim 13, wherein the physiological sensor includes at least one of a respiration sensor or a thoracic fluid sensor, and wherein the first heart failure status indicator includes at least one of a measure of respiration or a measure of thoracic fluid.

16. The method of claim 13, wherein the physiological sensor includes a heart sound sensor, and wherein the second heart failure status indicator includes a measure of a S3 heart sound.

17. The method of claim 13, wherein the biomarker includes at least one of BNP, NT-proBNP, ANP, MR-proANP, adrenomedullin, ST2, serum sodium, copeptin, CT-proET-1, adiponectin, 15 chromogranin A, proguanylin, prouroguanylin, hsTropinin-I, Corin, Urotensin, IL-6, hsCRP, miR423-5p, miRl29-5p, miR1254, HS_—

202.1, and miR622.

18. The method of claim 13, comprising providing an alert to the user or automated process when the amount of biomarker present exceeds a specified threshold value.

19. The method of claim 13, comprising providing an alert to the user or automated process when the second heart failure status indicator exceeds a specified threshold value.

20. A non-transitory device-readable medium including instructions that, when performed by a device, comprise:

using two or more ambulatory physiological sensors for providing a first heart failure status indicator using a first sensor selected from the two or more ambulatory physiological sensors and a second heart failure status indicator using a second sensor selected from the two or more ambulatory physiological sensors, the second sensor different from the first sensor;

using an external biomarker sensor, detecting an amount of a biomarker present in a biological substance to provide information about heart failure status; and

using information about the amount of biomarker present, switching from a first heart failure status detection mode detecting heart failure status using the first heart failure status indicator to a second heart failure status detection mode detecting heart failure status using a change over time in the second heart failure status indicator, the second heart failure status detection mode different from and having a higher specificity than the first heart failure status detection mode.