Automated collection and analysis patient care system and method for diagnosing and monitoring the outcomes of atrial fibrillation

• US 6,411,840 B1
• Filed: 11/16/1999
• Issued: 06/25/2002
• Est. Priority Date: 11/16/1999
• Status: Expired due to Term

• Current Assignee: Cardiac Intelligence Corp (Boston Scientific Corporation)
• Original Assignee: Cardiac Intelligence Corp (Boston Scientific Corporation)
• Inventors: Bardy, Gust H.
• Primary Examiner(s): EVANISKO, GEORGE ROBERT
• Application Number:
  US09/441,613
• Time in Patent Office: 952 Days
• Field of Search: 607/9, 607/4, 607/5, 607/14, 600/508, 600/509, 600/513, 600/518, 128/923, 128/920
• US Class Current: 600/513
• CPC Class Codes: A61B 5/0031 Implanted circuitry
• CPC Class Codes: A61B 5/349 Detecting specific parameters of the electrocardiograph cycle
• CPC Class Codes: A61B 5/361 Detecting fibrillation
• CPC Class Codes: A61N 1/3622 comprising two or more electrodes co-operating with different heart regions
• CPC Class Codes: A61N 1/37282 characterised by communication with experts in remote locations using a network
• CPC Class Codes: Y10S 128/923 by comparison of patient data to other data

Abstract

An automated system and method for diagnosing and monitoring the outcomes of atrial fibrillation is described. A plurality of monitoring sets is retrieved from a database. Each of the monitoring sets include recorded measures relating to patient information recorded on a substantially continuous basis. A patient status change is determined in response to an atrial fibrillation diagnosis by comparing at least one recorded measure from each of the monitoring sets to at least one other recorded measure. Both recorded measures relate to the same type of patient information. Each patient status change is tested against an indicator threshold corresponding to the same type of patient information as the recorded measures which were compared. The indicator threshold corresponds to a quantifiable physiological measure of a pathophysiology resulting from atrial fibrillation.

Claims

1. An automated system for diagnosing and monitoring outcomes of atrial fibrillation, comprising:

a database for storing a plurality of monitoring sets which each comprise recorded measures relating to patient information recorded on a substantially continuous basis;

a comparison module for receiving a diagnosis of atrial fibrillation and determining at least one patient status change in response to the atrial fibrillation diagnosis by comparing on a periodic basis at least one recorded measure from each of the monitoring sets to at least one other recorded measure from another of the monitoring sets with both recorded measures relating to a same type of patient information; and

an analysis module for evaluating on a periodic basis each patient status change for an absence, an onset, a progression, a regression, and a status quo of atrial fibrillation against a predetermined indicator threshold corresponding to the same type of patient information as the recorded measures which were compared, the indicator threshold corresponding to a quantifiable physiological measure of a pathophysiological diagnosis resulting from atrial fibrillation.

2. An automated system according to claim 1, further comprising:

an analysis submodule for-managing the atrial fibrillation diagnosis by controlling at least one of a ventricular rate response control unit and a normal sinus rhythm restoration unit.

3. An automated system according to claim 1, further comprising:

at least one of a medical device adapted to be implanted in an individual patient and an external medical device proximal to the individual patient;

a database submodule for periodically receiving the monitoring set for an individual patient, with each recorded measure in the monitoring set recorded by the at least one of a medical device adapted to be implanted and the external medical device and storing the received monitoring set in the database as part of a patient care record for the individual patient.

4. An automated system according to claim 3, further comprising:

a set of further indicator thresholds, each indicator threshold corresponding to a quantifiable physiological measure used to detect a pathophysiology indicative of diseases other than atrial fibrillation;

a comparison submodule for comparing each patient status change to each such further indicator threshold corresponding to the same type of patient information as the at least one recorded measure and the at least one other recorded measure from another of the monitoring sets and for testing each patient status change against each such further indicator threshold corresponding to the same type of patient information as the recorded measures which were compared.

5. An automated system according to claim 1, wherein the recorded measures comprise quality of life measures, further comprising:

a comparison submodule for determining a change in patient status by comparing at least one such recorded quality of life measure to at least one other such corresponding recorded quality of life measure.

6. An automated system according to claim 1, further comprising:

a set of stickiness indicators for each type of patient information, each stickiness indicator corresponding to a temporal limit related to a program of patient diagnosis or treatment;

a comparison submodule for measuring a time occurring between each patient status change for each recorded measure to the stickiness indicator relating to the same type of patient information as the recorded measure being compared; and

an analysis submodule for determining a revised program of patient diagnosis or treatment responsive to each patient status change occurring subsequent to the time following the stickiness indicator.

7. An automated system according to claim 1, further comprising:

a database submodule module for retrieving the plurality of monitoring sets from a patient care record for one of an individual patient, a peer group, and an overall patient population.

8. An automated system according to claim 1, further comprising:

the database for further storing a reference baseline comprising recorded measures which each relate to patient information recorded during an initial time period and comprise either medical device measures or derived measures; and

a database submodule obtaining at least one of the at least one recorded measure and the at least one other recorded measure from the reference baseline.

9. An automated system according to claim 1, wherein the indicator threshold relates to at least one of a finding of reduced exercise capacity, respiratory distress, palpitations or symptoms.

10. An automated system according to claim 9, wherein the indicator thresholds relating to the finding of reduced exercise capacity are selected from the group consisting of decreased cardiac output, decreased mixed venous oxygen score and decreased patient activity score.

11. An automated system according to claim 9, wherein the indicator thresholds relating to the finding of respiratory distress are selected from the group consisting of increased pulmonary artery diastolic pressure, increased respiratory rate and decreased transthoracic impedance.

12. An automated collection and analysis patient care system for diagnosing and monitoring outcomes of atrial fibrillation, comprising:

a database for storing a plurality of monitoring sets, each monitoring set comprising recorded measures which each relate to patient information and comprise either medical device measures or derived measures, the medical device measures having been recorded on a substantially continuous basis;

a set of stored indicator thresholds, each indicator threshold corresponding to a quantifiable physiological measure of a pathophysiological diagnosis resulting from atrial fibrillation and relating to the same type of patient information as at least one of the recorded measures; and

a diagnostic module diagnosing an atrial fibrillation finding, comprising;

an analysis module for receiving a diagnosis of atrial fibrillation and determining on a periodic basis a change in patient status in response to the atrial fibrillation diagnosis by comparing at least one recorded measure to at least one other recorded measure from another of the monitoring sets with both recorded measures relating to the same type of patient information; and

a comparison module for comparing on a periodic basis each patient status change for an absence, an onset, a progression, a regression, and a status quo of atrial fibrillation to the stored indicator threshold corresponding to the same type of patient information as the recorded measures which were compared.

13. A system according to claim 12, wherein the device measures are recorded by at least one of a medical device adapted to be implanted in an individual patient and an external medical device proximal to the individual patient when the device measures are recorded.

14. A system according to claim 12, wherein each of the monitoring sets comprises recorded measures relating to patient information solely for the individual patient, further comprising:

a database module for retrieving each monitoring set from a patient care record for an individual patient and for obtaining the at least one recorded measure and the at least one other recorded measure from the retrieved monitoring sets.

15. A system according to claim 12, wherein each of the monitoring sets comprises recorded measures relating to patient information for a peer group of patients to which the individual patient belongs, further comprising:

a database module for retrieving at least one monitoring set from a patient care record for the individual patient, for retrieving at least one other monitoring set from a patient care record in the same patient peer group, and for obtaining the at least one recorded measure from the at least one monitoring set and the at least one other recorded measure from the at least one other monitoring set.

16. A system according to claim 12, wherein each of the monitoring sets comprises recorded measures relating to patient information for a population of patients, further comprising:

a database module for retrieving at least one monitoring set from a patient care record for the individual patient, for retrieving at least one other monitoring set from a patient care record in the patient population, and for obtaining the at least one recorded measure from the at least one monitoring set and the at least one other recorded measure from the at least one other monitoring set.

17. A system according to claim 12, further comprising:

a medical device adapted to be implanted;

the database for further storing a reference baseline comprising recorded measures which each relate to patient information recorded by the medical device during an initial time period and comprise either device measures recorded by the medical device adapted to be implanted or derived measures; and

a database module for obtaining at least one of the at least one recorded measure and the at least one other recorded measure from the retrieved reference baseline.

18. A system according to claim 17, wherein the reference baseline comprises recorded measures relating to patient information for one of the individual patients solely, a peer group of patients to which the individual patient belongs, and a general population of patients.

19. A system according to claim 12, the comparison module further comprising:

a module for grading the comparisons between each patient status change and corresponding stored indicator threshold on a fixed scale based on a degree of deviation from the stored indicator threshold; and

the comparison module for determining an overall patient status change by performing a summation over the individual graded comparisons.

20. A system according to claim 12, the comparison module further comprising:

a module for determining probabilistic weightings of the comparisons between each patient status change and corresponding stored indicator threshold based on a statistical deviation and trends via linear fits from the stored indicator threshold; and

the comparison module for determining an overall patient status change by performing a summation over the individual graded comparisons.

21. A system according to claim 12, the diagnostic module further comprising:

a feedback module recording quality of life and symptom measures into each monitoring set;

a quality of life module for determining a change in patient status by comparing at least one recorded quality of life measure to at least one other corresponding recorded quality of life measure; and

the diagnostic module for incorporating each patient status change in quality of life into the atrial fibrillation finding to either refute or support the diagnosis.

22. A system according to claim 12, further comprising:

a set of stored further indicator thresholds, each stored further indicator threshold corresponding to a quantifiable physiological measure used to detect a pathophysiology indicative of diseases other than atrial fibrillation; and

the diagnostic module diagnosing a finding of a disease other than atrial fibrillation, the comparison module further comparing each patient status change to each such further indicator threshold corresponding to the same type of patient information as the at least one recorded measure and the at least one other recorded measure.

23. A system according to claim 12, further comprising:

a set of stickiness indicators, each stickiness indicator corresponding to a temporal limit related to a course of patient care; and

a feedback module for comparing a time span between each patient status change for each recorded measure to the stickiness indicator corresponding to the same type of patient information as the recorded measure being compared.

24. A system according to claim 12, further comprising:

a feedback module for providing automated feedback to the individual patient when an atrial fibrillation finding is diagnosed.

25. A system according to claim 24, further comprising:

the feedback module for performing an interactive dialogue between the individual patient and the patient care system regarding the individual patient.

26. An automated patient care system for diagnosing and monitoring outcomes of atrial fibrillation, comprising:

a database for storing recorded measures organized into a monitoring set for an individual patient with each recorded measure having been recorded on a substantially continuous basis and relating to at least one of monitoring reduced exercise capacity and respiratory distress;

a database module for periodically retrieving a plurality of the monitoring sets from the database; and

a diagnostic module for evaluating at least one of atrial fibrillation onset, progression, regression, and status quo, comprising;

a comparison module for receiving a diagnosis of atrial fibrillation and determining on a periodic basis a patient status change in response to the atrial fibrillation diagnosis by comparing at least one recorded measure from each of the monitoring sets to at least one other recorded measure with both recorded measures relating to the same type of patient information; and

an analysis module for testing on a periodic basis each patient status change for an absence, an onset, a progression, a regression, and a status quo of atrial fibrillation against a predetermined indicator threshold corresponding to the same type of patient information as the recorded measures which were compared, the predetermined indicator threshold corresponding to a quantifiable physiological measure of a pathophysiological diagnosis indicative of reduced exercise capacity and respiratory distress.

27. An automated system for managing a pathophysiological outcome of atrial fibrillation, comprising:

a database for storing a plurality of monitoring sets from a database which each comprises recorded measures relating to patient information recorded on a substantially continuous basis;

a comparison module for receiving a diagnosis of atrial fibrillation and determining on a periodic basis the pathophysiological outcome of atrial fibrillation in response to the atrial fibrillation diagnosis, by comparing at least one recorded measure from each of the monitoring sets to at least one other recorded measure from another of the monitoring sets with both recorded measures relating to a same type of patient information and for evaluating on a periodic basis each recorded measure comparison for an absence, an onset, a progression, a regression, and a status quo of atrial fibrillation against a predetermined indicator threshold corresponding to the same type of patient information as the recorded measures which were compared, the indicator threshold corresponding to a quantifiable physiological measure of a pathophysiological diagnosis resulting from atrial fibrillation; and

an analysis module for managing the atrial fibrillation outcome by interventively administering therapy contributing to normal sinus rhythm restoration and ventricular rate response control.

28. An automated system according to claim 27, wherein the pathophysiological outcome comprises a cardiovascular or cardiopulmonary compromise, further comprising:

a comparison submodule for measuring a magnitude of change and a time span occurrence and for classifying a severity of the cardiovascular or cardiopulmonary compromise according to the magnitude of change and the time span for each recorded measure comparison; and

an analysis submodule for generating a therapy regimen based on the severity, comprising, in decreasing order of severity;

for the cardiovascular or cardiopulmonary compromise with a highest severity, a submodule administering an aggressive atrial fibrillation therapy;

for the cardiovascular or cardiopulmonary compromise of second highest severity, a submodule administering initial anticoagulation management coupled with selective ventricular rate response control for atrial fibrillation of long term duration and administering an aggressive atrial fibrillation therapy in the presence of anticoagulation drug therapy;

for the cardiovascular or cardiopulmonary compromise of third highest severity, a submodule administering initial monitored anticoagulation management coupled with selective ventricular rate response control for atrial fibrillation of long term duration, administering a moderate atrial fibrillation therapy coupled with ventricular rate response control for atrial fibrillation of long term duration and administering a moderate atrial fibrillation therapy for atrial fibrillation in the absence of anticoagulation drug therapy; and

for the cardiovascular or cardiopulmonary compromise of least severity, a submodule administering initial anticoagulation management coupled with selective ventricular rate response control and on-going cardiovascular or cardiopulmonary monitoring for atrial fibrillation of long term duration, administering a modest atrial fibrillation therapy for atrial fibrillation of long term duration and administering a modest atrial fibrillation therapy for atrial fibrillation in the absence of anticoagulation drug therapy.

29. An automated system according to claim 27, wherein the pathophysiological outcome comprises an inappropriate ventricular rate response, farther comprising:

a comparison submodule for measuring an average ventricular rate and for classifying ventricular rate response according to the average ventricular rate; and

an analysis submodule for generating a therapy regimen based on the severity, comprising;

for overly slow ventricular rate response, a submodule performing at least one therapy selected from the group comprising increasing ventricular pacing rate and decreasing antidromotropic drug therapy; and

for overly rapid ventricular rate response, a submodule performing at least one therapy selected from the group comprising applying electrical therapy and administering initial drug therapy to decrease atrioventricular node conduction.

30. An automated system according to claim 27, wherein (he pathophysiological outcome comprises a pathophysiological condition requiring anticoagulation drug therapy, further comprising:

a comparison submodule for determining a duration for atrial fibrillation and anticoagulation drug therapy status; and

an analysis submodule for administering anticoagulation drug therapy for atrial fibrillation of long term duration in the absence of a contraindication of anticoagulation drug therapy or inadequacy thereof.

31. An automated system according to claim 27, wherein the pathophysiological outcome comprises palpitations or symptoms, further comprising:

a comparison submodule for classifying palpitations or symptoms according to disabling effect to the patient; and

an analysis submodule for generating a therapy regimen based on the classification, comprising;

for disabling palpitations or symptoms, a submodule administering a moderate atrial fibrillation therapy for atrial fibrillation; and

for non-disabling palpitations or symptoms, a submodule administering a modest atrial fibrillation therapy for atrial fibrillation.