Automated collection and analysis patient care system for managing the pathophysiological outcomes of atrial fibrillation

• US 6,694,186 B2
• Filed: 08/13/2001
• Issued: 02/17/2004
• Est. Priority Date: 11/16/1999
• Status: Expired due to Fees

• 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:
  US09/929,233
• Publication Number:
  US 20020029002A1
• Time in Patent Office: 918 Days
• Field of Search: 607/3, 607/4, 607/5, 607/9, 607/14, 600/508, 600/509, 600/513, 600/518, 128/920, 128/925
• US Class Current: 607/3
• 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 method for managing a pathophysiological outcome of atrial fibrillation, comprising:

retrieving a plurality of monitoring sets from a database with each monitoring set comprising recorded measures relating to patient information recorded on a substantially continuous basis;

diagnosing atrial fibrillation;

determining a pathophysiological outcome of atrial fibrillation in response to the atrial fibrillation diagnosis for an absence, an onset, a progression, regression, and a status quo of atrial fibrillation, comprising;

comparing at least one of the recorded measures from each of the monitoring sets to at least one other of the recorded measures with both recorded measures relating to the same type of patient information; and

testing the recorded measure comparison against an indicator threshold corresponding to the same type of patient information as the recorded measures which were compared to form the atrial fibrillation pathophysiological outcome, the indicator threshold corresponding to a quantifiable physiological measure of a pathophysiology resulting from atrial fibrillation; and

managing the atrial fibrillation pathophysiological outcome through interventive administration of a therapy contributing to normal sinus rhythm restoration and ventricular rate response control.

2. An automated method according to claim 1, wherein the pathophysiological outcome comprises a cardiovascular/cardiopulmonary compromise, the automated method further comprising:

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

generating a therapy regimen based on the severity, comprising, in decreasing order of severity;

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

for the cardiovascular/cardiopulmonary compromise of second highest severity, 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/cardiopulmonary compromise of third highest severity, 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/cardiopulmonary compromise of least severity, administering initial anticoagulation management coupled with selective ventricular rate response control and on-going cardiovascular/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.

3. An automated method according to claim 1, wherein the pathophysiological outcome comprises an inappropriate ventricular rate response, the automated method further comprising:

classifying the inappropriate ventricular rate response according to an average ventricular rate; and

generating a therapy regimen based on a severity, comprising;

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

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

4. An automated method according to claim 1, wherein the pathophysiological outcome comprises a pathophysiological condition requiring anticoagulation drug therapy, the automated method further comprising:

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

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

5. An automated method according to claim 1, wherein the pathophysiological outcome comprises palpitations/symptoms, the automated method further comprising:

classifying the palpitations/symptoms according to disabling effect to the patient; and

generating a therapy regimen based on the classification, comprising;

for disabling palpitations/symptoms, administering a moderate atrial fibrillation therapy for atrial fibrillation;

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

6. A computer-readable storage medium holding code for managing a pathophysiological outcome of atrial fibrillation, the code having instructions comprising:

code for retrieving a plurality of monitoring sets from a database with each monitoring set comprising recorded measures relating to patient information recorded on a substantially continuous basis;

code for diagnosing atrial fibrillation;

code for determining a pathophysiological outcome of atrial fibrillation in response to the atrial fibrillation diagnosis for an absence, an onset, a progression, a regression, and a status quo of atrial fibrillation, comprising;

code for comparing at least one of the recorded measures from each of the monitoring sets to at least one other of the recorded measures both recorded measures relating to the same type of patient information; and

code for testing the recorded measure comparison against an indicator threshold corresponding to the same type of patient information as the recorded measures which were compared to form the atrial fibrillation pathophysiological outcome, the indicator threshold corresponding to a quantifiable physiological measure of a pathophysiology resulting from atrial fibrillation; and

code for managing the atrial fibrillation pathophysiological outcome through interventive administration of a therapy contributing to normal sinus rhythm restoration and ventricular rate response control.

7. A storage medium according to claim 6, wherein the pathophysiological outcome comprises a cardiovascular/cardiopulmonary compromise, the code further comprising:

code for classifying a severity of the cardiovascular/cardiopulmonary compromise according to magnitude of a change and a time span occurrence for the recorded measure comparison, and

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

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

for the cardiovascular/cardiopulmonary compromise of second highest severity, 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/cardiopulmonary compromise of third highest severity, 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/cardiopulmonary compromise of least severity, administering initial anticoagulation management coupled with selective ventricular rate response control and on-going cardiovascular/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.

8. A storage medium according to claim 6, wherein the pathophysiological outcome comprises an inappropriate ventricular rate response, the code further comprising:

code for classifying the inappropriate ventricular rate response according to an average ventricular rate; and

code for generating a therapy regimen based on a severity, comprising;

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

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

9. A storage medium according to claim 6, wherein the pathophysiological outcome comprises a pathophysiological condition requiring anticoagulation drug therapy, the code further comprising:

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

code 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.

10. A storage medium according to claim 6, wherein the pathophysiological outcome comprises palpitations/symptoms, the code further comprising:

code for classifying the palpitations/symptoms according to disabling effect to the patient; and

code for generating a therapy regimen based on the classification, comprising;

for disabling palpitations/symptoms, administering a moderate atrial fibrillation therapy for atrial fibrillation;

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