SYSTEM FOR EVALUATING PERFORMANCE OF AN IMPLANTABLE MEDICAL DEVICE

• US 20090043355A1
• Filed: 08/08/2007
• Published: 02/12/2009
• Est. Priority Date: 08/08/2007
• Status: Active Grant

• Current Assignee: Cardiac Pacemakers Incorporated (Boston Scientific Corporation)
• Original Assignee: Cardiac Pacemakers Incorporated (Boston Scientific Corporation)
• Inventors: Sachanandani, Haresh G., Cazares, Shelley M., Li, Dan, Dong, Yanting, Ettori, Benjamin
• Granted Patent: US 8,036,735 B2
• Time in Patent Office: Days
• US Class Current: 607/32
• CPC Class Codes: A61B 5/0031 Implanted circuitry
• 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 1/36585 controlled by two or more physical parameters
• CPC Class Codes: A61N 1/37282 characterised by communication with experts in remote locations using a network
• CPC Class Codes: G16H 40/63 for local operation
• CPC Class Codes: G16H 40/67 for remote operation

Abstract

A system evaluates the performance of an implantable medical device, such as by using a remote external server and a user interface and stored historical physiological data of a population of congestive heart failure (CHF) patients. A processor is coupled to a patient data storage device to apply multiple algorithm variations against the same implantable physiological data from the patient to produce corresponding resulting CHF indicators. The user interface includes a display that is configured to display to a user information allowing comparison between the resulting CHF indicators from the multiple algorithm variations. The display also includes a population data selector to permit the user to select physiological data from a population that includes a different set of one or more patients or physiological data collected over a period of time from the patient. This permits optimization of an algorithm parameter or selection of a best performing algorithm.

Claims

1. A system for use with an implantable medical device, the system comprising:

a remote external server, comprising;

a physiological data input, configured to receive physiological data into a patient data storage device that stores historical physiological data of a population of congestive heart failure (CHF) patients, the physiological data input comprising an implantable physiological data input configured to receive implantable physiological data from an implantable physiological sensor of a first patient;

a processor, coupled to the patient data storage device, the processor configured to apply multiple algorithm variations against the same implantable physiological data from the first patient to produce corresponding resulting CHF indicators; and

a local or remote external user interface, configured to be coupled to the remote external server using a communications network, the user interface comprising a display, configured to display to a user information allowing comparison between the resulting CHF indicators from the multiple algorithm variations, and the display including a population data selector configured to permit the user to select physiological data from a population comprising a different set of one or more patients or physiological data collected over a period of time from the first patient, thereby further allowing an optimization of an algorithm parameter or a selection of a best performing algorithm.

2. The system of claim 1, wherein the display includes at least one of an indication of a frequency or a severity of CHF decompensation events that are included in the physiological data.

3. The system of claim 1, wherein the display includes a graphical or tabular representation of a metric relating to a false negative versus a metric relating to a false positive characterizing the multiple algorithm variations.

4. The system of claim 3, wherein the display is in the form of a receiver operating characteristic (ROC).

5. The system of claim 1, wherein the population data selector includes a criterion of physiological similarity to the first patient for selecting a candidate different second patient, wherein the criterion includes at least one of age, gender, ethnicity, left ventricular ejection fraction, New York Heart Association heart failure classification, six minute walk test results, a quality of life measure, a heart failure etiology, a body mass index, a blood pressure, a medication, a co-morbidity, an arrhythmia history, an implant history, a patient treatment compliance, a health care system, a circadian rhythm, a geographic location, patients who have survived for a particular time frame, and patients who have not decompensated or experienced other cardiac events in a particular time frame.

6. The system of claim 1, wherein the multiple algorithm variations include multiple variations of at least one of a CHF detection algorithm, a CHF classification algorithm, or a CHF prediction algorithm.

7. The system of claim 1, wherein the local or remote external user interface is configured to accept user input limiting values for the implantable physiological data to a particular range of values.

8. The system of claim 1, wherein the implantable medical device includes at least one of an implantable cardiac defibrillator, a cardiac resynchronization therapy device, and a pacer.

9. The system of claim 1, wherein the implantable medical device is configured to measure at least one of a heart sound, a heart rate, a heart rate turbulence, a heart rate variability, a pulmonary artery pressure, an electrogram morphology, a blood pressure, a thoracic impedance, a respiration rate, and a heart failure index.

10. The system of claim 1, wherein the physiological data input comprises an external physiological data input configured to receive external physiological data from an external physiological sensor associated with, but external to, the first patient, and wherein the external physiological data includes at least one of a body weight, a systolic blood pressure, a diastolic blood pressure, a response to health symptoms questions, and a glucose level.

11. The system of claim 1, wherein the multiple algorithm variations include at least one of an alteration of algorithm program code or an alteration of an algorithm parameter.

12. The system of claim 1, wherein the processor is configured to automatically reprogram the implantable medical device with an algorithm selected from the multiple algorithm variations.

13. The system of claim 12, wherein the processor is configured to automatically program the implantable medical device as a function of an area under a receiver operator characteristic curve.

14. The system of claim 12, wherein the processor is configured to automatically program the implantable medical device as a function of a false positive rate and a sensitivity.

15. The system of claim 1, wherein the processor is configured to receive input from a user for selecting an algorithm from the multiple algorithm variations to program into the implantable medical device.

16. A process comprising:

receiving, at a physiological data input of a remote external server, physiological data into a patient data storage device that stores historical physiological data of a population of congestive heart failure (CHF) patients, wherein the physiological data input comprises an implantable physiological data input configured to receive implantable physiological data from an implantable physiological sensor of a first patient;

applying multiple algorithm variations against the same implantable physiological data from the first patient to produce corresponding resulting CHF indicators; and

displaying, on a local or remote user interface, a comparison between the resulting CHF indicators from the multiple algorithm variations, and displaying, on the local or remote user interface, a population data selector configured to permit the user to select physiological data from a different set of one or more patients or physiological data collected over a period of time from the first patient; and

optimizing an algorithm parameter or a selection of a best performing algorithm as a function of the multiple algorithm variations.

17. The process of claim 16, comprising displaying on the local or remote user interface at least one of an indication of a frequency or a severity of CHF decompensation events that are included in the physiological data.

18. The process of claim 16, wherein the displaying includes a graphical or tabular representation of a metric relating to a false negative versus a metric relating to a false positive characterizing the multiple algorithm variations.

19. The process of claim 18, wherein the displaying on the local or remote user interface is in the form of a receiver operating characteristic (ROC).

20. The process of claim 18, comprising providing an option to select one or more values for at least one tunable algorithm parameter as a function of receiver operating characteristic information.

21. The process of claim 16, comprising configuring the local or remote user interface to accept user input limiting values of the implantable physiological data to a particular range of data.

22. The process of claim 16, comprising configuring the physiological data input to receive external physiological data from an external physiological sensor associated with the first patient.

23. The process of claim 16, comprising automatically reprogramming the implantable medical device with an algorithm automatically selected from the multiple algorithm variations.

24. The process of claim 16, comprising receiving input from a user relating to an algorithm to select from the multiple algorithm variations to program into the implantable medical device.

25. A system for use with an implantable medical device, the system comprising:

remote external server means, comprising;

physiological data input means, configured to receive physiological data into a patient data storage device that stores historical physiological data of a population of congestive heart failure (CHF) patients, the physiological data input means comprising an implantable physiological data input, configured to receive implantable physiological data from an implantable physiological sensor of a first patient;

processor means, coupled to the patient data storage device, the processor means configured to apply multiple algorithm variations against the same implantable physiological data from the first patient to produce corresponding resulting CHF indicators; and

local or remote external user interface means, configured to be coupled to the remote external server means using a communications network, the user interface comprising a display means, configured to display to a user information allowing comparison between the resulting CHF indicators from the multiple algorithm variations, and the display means including a population data selector configured to permit the user to select physiological data from a population comprising a different set of one or more patients or physiological data collected over a period of time from the first patient, thereby further allowing an optimization of an algorithm parameter or a selection of a best performing algorithm.