Method and apparatus for monitoring drug effects on cardiac electrical signals using an implantable cardiac stimulation device

• US 7,142,911 B2
• Filed: 06/26/2003
• Issued: 11/28/2006
• Est. Priority Date: 06/26/2003
• Status: Expired due to Fees

• Current Assignee: Pacesetter Incorporated (Abbott Laboratories Incorporated)
• Original Assignee: Pacesetter Incorporated (Abbott Laboratories Incorporated)
• Inventors: Boileau, Peter, Florio, Joseph J., Bradley, Kerry, Falkenberg, Eric, Bornzin, Gene A., Barstad, Janice
• Primary Examiner(s): Pezzuto, Robert E.
• Assistant Examiner(s): MALAMUD, DEBORAH LESLIE
• Application Number:
  US10/608,409
• Publication Number:
  US 20040267321A1
• Time in Patent Office: 1,251 Days
• Field of Search: 607/3, 607/5, 607 7- 9, 607/14, 607/17, 607 25- 27, 607/30, 607/31, 607/123, 607/63, 607/22, 600/515, 600/518, 600/508, 600/510, 514/821, 424/9.1, 424/9.2
• US Class Current: 607/3
• CPC Class Codes: A61B 5/0031 Implanted circuitry
• CPC Class Codes: A61B 5/35 by template matching
• CPC Class Codes: A61B 5/4839 combined with drug delivery
• CPC Class Codes: A61M 2205/3523 using telemetric means
• CPC Class Codes: A61M 2205/3553 remote, e.g. between patient's home and doctor's office
• CPC Class Codes: A61M 2230/10 Electroencephalographic signals
• CPC Class Codes: A61M 5/14276 specially adapted for implantation
• CPC Class Codes: A61M 5/1723 using feedback of body parameters, e.g. blood-sugar, pressure measurement of body parameters A61B5/00
• CPC Class Codes: A61N 1/3622 comprising two or more electrodes co-operating with different heart regions
• CPC Class Codes: G16H 20/10 relating to drugs or medications, e.g. for ensuring correct administration to patients
• CPC Class Codes: G16H 20/30 relating to physical therapies or activities, e.g. physiotherapy, acupressure or exercising
• CPC Class Codes: G16H 50/20 for computer-aided diagnosis, e.g. based on medical expert systems

Abstract

An implantable cardiac stimulation device, such as a pacemaker or Implantable Cardioverter Defibrillator, is configured to automatically monitor the effects of antiarrhythmic drugs on cardiac electrical signals within a patient to verify the efficacy of the drugs taken. In one example, an analysis of patient cardiac electrical signals is performed by comparing the cardiac electrical signals with values representative of the effects of different classes of antiarrhythmic drugs. If the implantable device determines that the prescribed antiarrhythmic drugs have not been effective, a warning signal is generated. The warning signal is conveyed directly to the patient via a bedside monitor and to the patient'"'"'s physician via remote connection to an external programmer device so that both are notified of the drug efficacy problems. Additionally, the implantable device may be configured to automatically adjust pacing and defibrillation control parameters in an attempt to compensate for any lack of efficacy in the drugs. For example, the aggressiveness of overdrive pacing may be increased. Alternatively, a drug pump is controlled to adjust the dosage of antiarrhythmic drugs if an initial dosage is found to be ineffective.

Claims

1. A method comprising:

administering an antiarrhythmic drug to a patient;

receiving patient cardiac electrical signals via an implantable cardiac stimulation device implanted in the patient;

analyzing the patient cardiac electrical signals to detect the effects, if any, on the cardiac electrical signals caused by the antiarrhythmic drug; and

automatically controlling operation of the implantable cardiac stimulation device based on results of the analysis of the patient cardiac electrical signals;

wherein analyzing the patient cardiac electrical signals comprises determining the most likely class of antiarrhythmic drugs, taken by the patient.

2. The method of claim 1 wherein analyzing the patient cardiac electrical signals comprises analyzing features of events within the signals including one or more of event duration, event slope, time between events, and event variability.

3. The method of claim 1 wherein controlling operation of the implantable cardiac stimulation device comprises outputting a warning signal if the efficacy of the antiarrhythmic drugs falls below a predetermined threshold.

4. The method of claim 1 further comprising inputting a value identifying an antiarrhythmic drug prescribed to the patient and its class and wherein controlling operation of the implantable cardiac stimulation device includes the step of outputting a warning signal if the class of the prescribed drug does not match the class of antiarrhythmic drugs found to have been taken by the patient.

5. The method of claim 1 wherein the implantable cardiac stimulation device includes a drug pump for delivering antiarrhythmic drugs to the patient and wherein controlling operation of the implantable cardiac stimulation device comprises adjusting a dosage of antiarrhythmic drugs delivered by the drug pump based on the results of the analysis of the patient cardiac electrical signals.

6. The method of claim 1 wherein the implantable cardiac stimulation device is capable of performing cardiac pacing and wherein controlling operation of the implantable cardiac stimulation device comprises controlling cardiac pacing based on the results of the analysis of the patient cardiac electrical signals.

7. The method of claim 6 wherein the implantable cardiac stimulation device is capable of performing dynamic overdrive pacing and wherein controlling cardiac pacing comprises controlling an aggressiveness of the overdrive pacing based on the results of the analysis of the patient cardiac electrical signals.

8. The method of claim 1 wherein the implantable cardiac stimulation device is capable of performing defibrillation functions and wherein controlling operation of the implantable cardiac stimulation device comprises controlling defibrillation functions based on the results of the analysis of the patient cardiac electrical signals.

9. The method of claim of 1 wherein the implantable cardiac stimulation device includes a sensor for sensing a physiological parameter affected by anti-arrhythmic drugs and further comprising:

inputting physiological signals from The sensor; and

analyzing the physiological signals to corroborate the results of the analysis of the patient cardiac electrical signals.

10. The method of claim 1 wherein analyzing the patient cardiac electrical signals comprises:

inputting values representative of expected changes to features of cardiac electrical signals caused by antiarrhythmic drugs; and

comparing features of patient cardiac electrical signals detected after administration of an antiarrhythmic drug with corresponding features of cardiac electrical signals detected before administration of the drug to verify that the expected changes occurred.

11. The method of claim 1 wherein analyzing the patient cardiac electrical signals comprises:

inputting templates representative of the expected quantitative features of cardiac electrical signals as affected by antiarrhythmic drugs; and

comparing portions of the patient cardiac electrical signals with the templates to detect the effects, if any, on the cardiac electrical signals caused by antiarrhythmic drugs.

12. The method of claim 1 wherein analyzing the patient cardiac electrical signals comprises:

inputting templates representative of expected qualitative changes to features of cardiac electrical signals caused by antiarrhythmic drugs; and

comparing portions of the patient cardiac electrical signals with the templates to detect the effects, if any, on the cardiac electrical signals caused by antiarrhythmic drugs.

13. The method of claim 1 wherein analyzing the patient cardiac electrical signals is performed using only patient cardiac electrical signals detected at substantially the same time of day.

14. The method of claim 1 wherein analyzing the patient cardiac electrical signals cardiac is performed using only averaged patient cardiac electrical signals.

15. The method of claim 1 wherein analyzing the patient cardiac electrical signals to detect the effects, if any, on the cardiac electrical signals caused by antiarrhythmic drugs includes the step of tracking RT intervals affected by antiarrhythmic drugs.

16. A method comprising:

administering an antiarrhythmic drug to a patient;

receiving patient cardiac electrical signals via an implantable cardiac stimulation device implanted in the patient;

analyzing the patient cardiac electrical signals to detect the effects, if any, on the cardiac electrical signals caused by the antiarrhythmic drug; and

automatically controlling operation of the implantable cardiac stimulation device based on results of the analysis of the patient cardiac electrical signals;

wherein analyzing the patient cardiac electrical signals to detect the effects, if any, on the cardiac electrical signals caused by antiarrhythmic drugs includes the step of tracking RT intervals affected by antiarrhythmic drugs;

for use with patients receiving Class III antiarrhythmic drugs wherein controlling operation of the implantable cardiac stimulation device comprises generating a notification signal when RT intervals have returned to a nominal state following patient receipt of the Class III antiarrhythmic drugs.

17. In an implantable cardiac stimulation device for implant within a patient, a system comprising:

means for administering antiarrhythmic drugs to the patient;

means for receiving patient cardiac electrical signals;

means for analyzing the patient cardiac electrical signals to detect the effects, if any, on the cardiac electrical signals caused by antiarrhythmic drugs; and

means for controlling operation of the implantable cardiac stimulation device based on the results of the analysis of the patient cardiac electrical signals;

wherein the means for analyzing the patient cardiac electrical signals comprises determining the most likely class of antiarrhythmic drugs, taken by patient.

18. A method comprising:

prescribing at least one specific antiarrhythmic drug to a patient;

receiving patient cardiac electrical signals via an implantable cardiac stimulation device implanted in the patient;

analyzing the patient cardiac electrical signals to monitor for a particular result expected to result from the at least one specific antiarrhythmic drug; and

generating a warning signal if the particular result is not detected;

wherein analyzing the patient cardiac electrical signals comprises determining the most likely class of antiarrhythmic drugs, taken by the patient.