System for identifying candidates for ICD implantation

• US 20040230456A1
• Filed: 05/14/2003
• Published: 11/18/2004
• Est. Priority Date: 05/14/2003
• Status: Abandoned Application

• Current Assignee: Cardiac Pacemakers Incorporated (Boston Scientific Corporation)
• Original Assignee: Cardiac Pacemakers Incorporated (Boston Scientific Corporation)
• Inventors: Johnson, Robert J. Jr., Gervais, Scott, Lozier, Luke R., Webber, Sarah, Roman, Carlos, Gilliam, F. Roosevelt III
• Application Number:
  US10/438,261
• Publication Number:
  US 20040230456A1
• Time in Patent Office: Days
• US Class Current: 705/2
• CPC Class Codes: G16H 10/20 for electronic clinical trials or questionnaires
• CPC Class Codes: G16H 10/60 for patient-specific data, e.g. for electronic patient records
• CPC Class Codes: G16H 15/00 ICT specially adapted for medical reports, e.g. generation or transmission thereof
• CPC Class Codes: G16H 20/40 relating to mechanical, radiation or invasive therapies, e.g. surgery, laser therapy, dialysis or acupuncture
• CPC Class Codes: G16H 40/67 for remote operation
• CPC Class Codes: G16H 50/30 for calculating health indices; for individual health risk assessment

Abstract

A software system for identifying patients who may be appropriate candidates for implantation with an implantable cardioverter/defibrillator (ICD) is disclosed. The system particularly identifies those patients who are at increased risk for sudden cardiac death based upon a history of a prior heart attack and left ventricular dysfunction.

Claims

1. A software system for aiding in the identification of patients suitable for implantation with an implantable cardioverter/defibrillator (ICD), comprising:

a local database for storing a plurality of patient records, wherein each patient record has a plurality of data fields;

a clinical data manager for providing a user interface to the local database by which a user may add, delete, and modify patient records and for providing logic to analyze the patient records and present information derived therefrom to the user;

a user-enterable data field in each patient record for containing a patient identifier which identifies a particular patient associated with the record;

a user-enterable data field in each patient record for containing an indicator as to whether the patient associated with the record has a history of myocardial infarction (MI);

a user-enterable data field in each patient record for containing a measured ejection fraction (EF) of the patient associated with the record;

a user-defined variable designated EF-CEILING for representing the value of an EF below which left-ventricular dysfunction is considered to exist;

a calculated data field in each patient record for indicating whether the patient is at risk for sudden cardiac death (SCD), wherein the value of the SCD risk field is “

yes”

if the patient has a history of MI and the patient'"'"'s EF is less than EF-CEILING, and “

no”

otherwise;

a calculated data field in each patient record for indicating whether the patient meets the MADIT II criteria for ICD implantation, wherein the value of the MADIT II criteria field is “

yes”

if the patient has a history of MI and the patient'"'"'s EF is less than or equal to 30%, and “

no”

otherwise;

a data field in each patient record for indicating whether the patient has been stratified for arrhythmias by electrophysiological monitoring, wherein the value of the stratified for arrhythmias field is user-enterable to be either “

yes”

or “

no”

only if the SCD risk field is “

yes” and

the MADIT II criteria field is “

no,” and

is inactive otherwise; and

,

a data field in each patient record for indicating whether or not the patient has received an ICD, wherein the value of the received ICD field is user-enterable to be either “

yes”

or “

no”

only if;

     1) the MADIT II criteria field is “

yes”

or

     2) the stratified for arrhythmias field is “

yes,” and

inactive otherwise.

2. The system of claim 1 wherein the clinical data manager further comprises client/server software for communicating over a network and enabling the patient records in the local database to be synchronized with a remote database or to synchronize the patient records of the remote database with the local database.

3. The system of claim 1 further comprising a user-enterable data field in each patient record for containing a measured QRS duration of the patient associated with the record.

4. The system of claim 1 wherein the clinical data manager may be configured by the user to sort the data records for presentation in an order based upon the value of a selected data field.

5. The system of claim 1 wherein a data field of a presented patient record is color-coded according to the value of the data field.

6. The system of claim 5 wherein the EF data field of a presented patient record is color-coded according to whether the value contained in the field is less than or equal to 30%, greater than 30% but less than EF-CEILING, or greater than or equal to EF-CEILING.

7. The system of claim 5 wherein the received ICD field of a presented patient record is color-coded according to whether the value contained in the field is yes, no, or inactive.

8. The system of claim 5 wherein the stratified for arrhythmias field of a presented patient record is color-coded according to whether the value contained in the field is yes, no, or inactive.

9. The system of claim 5 wherein the SCD risk field of a presented patient record is color-coded according to whether the value contained in the field is yes or no.

10. The system of claim 5 wherein the MADIT II criteria field of a presented patient record is color-coded according to whether the value contained in the field is yes or no.

11. The system of claim 1 further comprising a user-enterable data field in each patient record for containing a gender designation of the patient associated with the record.

12. The system of claim 1 further comprising a user-enterable data field in each patient record for containing an identifier of the physician who ordered an EF test for the patient associated with the record.

13. The system of claim 1 further comprising a user-enterable data field in each patient record for containing a date on which the patient record was last updated.

14. The system of claim 1 wherein the clinical data manager may be configured by the user to present the patient records hierarchically sorted by selected data fields.

15. The system of claim 1 wherein the patient identifier field of each patient record contains the name of the patient associated with the record.

16. The system of claim 1 wherein the patient identifier field of each patient record contains a secret identifying code for the patient associated with the record.