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

• US 9,232,897 B2
• Filed: 09/30/2013
• Issued: 01/12/2016
• 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:
  US14/041,682
• Publication Number:
  US 20140031641A1
• Time in Patent Office: 834 Days
• US Class Current: 1/1
• 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. A medical system, comprising:

an ambulatory medical device (AMD), including a signal analyzer circuit coupled to at least first and second ambulatory physiologic sensors, the signal analyzer circuit configured to produce a first heart failure (HF) status indicator using the first ambulatory physiologic sensor and a second HF status indicator using the second ambulatory physiologic sensor;

an external biomarker device, including a biomarker sensor configured to provide information about an amount of a biomarker present in a biological substance, the amount of the biomarker present indicative of HF status; and

a patient monitor communicatively coupled to the AMD and the external device, the patient monitor including;

a receiver circuit configured to receive from the AMD information including the first and second HF status indicators, and to receive from the external biomarker device information including the amount of the biomarker present;

a processor circuit configured to select one of first and second HF status detection modes in response to the information from the biomarker device, and to generate an indicator of worsening of HF using the selected HF status detection mode, the first HF status detection mode detecting HF status using the first HF status indicator and the second HF status detection mode detecting HF status using the second HF status indicator, the second HF status detection mode different from and having a higher specificity than the first HF status detection mode; and

an output unit configured to output the indicator of worsening of HF.

2. The system of claim 1, wherein the AMD is an implantable cardiac device configured to monitor progression of HF status.

3. The system of claim 1, wherein at least one of the first and second ambulatory physiologic sensors includes an impedance sensor, and wherein the signal analyzer circuit is configured to produce the HF status indicator including at least one measure of tissue impedance.

4. The system of claim 1, wherein at least one of the first and second ambulatory physiologic sensors includes a respiration sensor, and wherein the signal analyzer circuit is configured to produce the HF status indicator including at least one of a measure of respiration rate, respiration depth, or a respiration morphological pattern.

5. The system of claim 1, wherein at least one of the first and second ambulatory physiologic sensors includes a heart sound sensor, and wherein the signal analyzer circuit is configured to produce the HF status indicator including at least one measure of heart sound component.

6. The system of claim 1, wherein the external biomarker device is configured to provide information about an amount of a biomarker including 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, miR129-5p, miR1254, HS_—

202.1, or miR622.

7. The system of claim 1, wherein the patient monitor includes a remote computer or a remote server.

8. The system of claim 1, wherein the processor circuit is configured to select between the first and second HF status detection modes in response to the amount of biomarker present being within a specified threshold range, and wherein the first HF status detection mode is configured to detect HF status using a measure of respiration or a measure of thoracic fluid, the second HF status detection mode detects HF status using a measure of a S3 heart sound.

9. The system of claim 1, comprising a local interface unit communicatively coupled to the AMD and the patient monitor, wherein the local interface unit is configured to receive from the AMD the information including the first and second HF status indicators and communicate the information to the patient monitor via a wired or wireless communication network.

10. The system of claim 9, wherein the local interface unit includes at least one of a programmer, a repeater, or a handheld device.

11. The system of claim 9, wherein the local interface unit is configured to communicate to the patient monitor via a telephone network.

12. The system of claim 9, wherein the local interface unit is configured to communicate to the patient monitor via a computer network.

13. The system of claim 1, wherein the processor circuit of the patient monitor is configured to:

when the first HF status detection mode is selected, generate the indicator of worsening of HF in response to the first HF status indicator meeting a first specified criterion and the amount of biomarker present being within a first specified range; and

when the second HF status detection mode is selected, generate the indicator of worsening of HF in response to the second HF status indicator meeting a second specified criterion and the amount of biomarker present being within a second specified range.

14. The system of claim 1, wherein the output unit is configured to output the indicator of worsening of HF to a user or an automated process, the indicator of worsening of HF including an alarm or an alert.

15. A method for operating a medical system for monitoring heart failure (HF) of a patient, the method comprising:

sensing at least first and second physiologic signals from the patient using an ambulatory medical device (AMD);

producing a first HF status indicator using the first physiologic signal and a second HF status indicator using the second physiologic signal;

detecting information about an amount of a biomarker present in a biological substance using an external biomarker sensor, the amount of the biomarker present indicative of HF status;

communicating the first and second HF status indicators and the information about the amount of the biomarker present to a patient monitor;

using the patient monitor, selecting one of first and second HF status detection modes in response to the information about the amount of the biomarker present, the first HF status detection mode detecting HF status using the first HF status indicator and the second HF status detection mode detecting HF status using the second HF status indicator, the second HF status detection mode different from and having a higher specificity than the first HF status detection mode; and

generating an indicator of worsening of HF using the selected HF status detection mode.

16. The method of claim 15, comprising outputting the indicator of worsening of HF to a user or an automated process, the indicator of worsening of HF including an alarm or an alert.

17. The method of claim 15, wherein detecting the information about the amount of the biomarker present includes detecting an amount of 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, miR129-5p, miR1254, HS_—

202.1, or miR622.

18. The method of claim 15, wherein sensing the at least first and second physiologic signals includes sensing one or more of an impedance signals, a respiration signal, or a heart sound signal.

19. The method of claim 15, wherein the first HF status detection mode detects HF status using a measure of respiration or a measure of thoracic fluid, the second HF status detection mode detects HF status using a measure of a S3 heart sound, and wherein selecting the one detection mode includes selecting between the first and second HF status detection modes in response to the amount of biomarker present being within a specified threshold range.

20. The method of claim 15, wherein generating the indicator of worsening of HF includes:

when the first HF status detection mode is selected, generating the indicator of worsening of HF in response to the first HF status indicator meeting a first specified criterion and the amount of biomarker present being within a first specified range; and

when the second HF status detection mode is selected, generating the indicator of worsening of HF in response to the second HF status indicator meeting a second specified criterion and the amount of biomarker present being within a second specified range.