Method and apparatus for monitoring arrythmogenic effects of medications using an implantable device

• US 9,149,199 B2
• Filed: 12/03/2014
• Issued: 10/06/2015
• Est. Priority Date: 01/16/2007
• Status: Active Grant

• Current Assignee: Pacesetter Incorporated (Abbott Laboratories Incorporated)
• Original Assignee: Pacesetter Incorporated (Abbott Laboratories Incorporated)
• Inventors: Farazi, Taraneh Ghaffari
• Primary Examiner(s): Heller, Tammie K
• Application Number:
  US14/559,097
• Publication Number:
  US 20150088017A1
• Time in Patent Office: 307 Days
• US Class Current: 1/1
• CPC Class Codes: A61B 5/349 Detecting specific parameters of the electrocardiograph cycle
• CPC Class Codes: A61B 5/35 by template matching
• CPC Class Codes: A61B 5/4839 combined with drug delivery
• CPC Class Codes: A61B 5/4848 Monitoring or testing the effects of treatment, e.g. of medication
• CPC Class Codes: A61N 1/0563 specially adapted for defibrillation or cardioversion
• CPC Class Codes: A61N 1/3622 comprising two or more electrodes co-operating with different heart regions
• CPC Class Codes: A61N 1/36507 controlled by gradient or slope of the heart potential
• CPC Class Codes: A61N 1/36592 controlled by the heart rate variability
• CPC Class Codes: A61N 1/3684 for stimulating the heart at multiple sites of the ventricle or the atrium
• CPC Class Codes: A61N 1/36842 Multi-site stimulation in the same chamber
• CPC Class Codes: A61N 1/37211 Means for communicating with stimulators

Abstract

An implantable device and method for monitoring changes in the risk of arrhythmia induced by medications. The implantable device monitors risk of arrhythmia by analyzing an aspect of T-wave morphology to generate a metric of transmural dispersion of repolarization (“TDR”) as a proxy for the risk of arrhythmia. The implantable device generates an index of change in the risk of arrhythmia by comparing values of the metric of TDR obtained for different time periods. The implantable device generates a warning if the change in risk of arrhythmia is outside acceptable limits. The implantable device can also communicate with other devices to correlate changes in risk of arrhythmia with medications taken by the patient.

Claims

1. A method performed by an external device in conjunction with an implantable medical device implanted within a patient, the method comprising:

(a) during a first time period, following administration of a medication, obtaining an electrogram (EGM) signal from a patient via the implantable medical device, and analyzing in the implantable medical device one or more attributes of T-waves of the EGM signal to generate a first metric representative of transmural dispersion of repolarization (TDR);

(b) during a second time period, following the administration of the medication, obtaining a further EGM signal from the patient via the implantable medical device, and analyzing in the implantable medical device one or more attributes of T-waves of the EGM signal to generate a further metric representative of TDR;

(c) recording in the implantable device TDR data representing the first and further metric of transmural dispersion of repolarization obtained at the first and second time periods;

(d) communicating said TDR data from the implantable device to the external device;

(e) determining in the external device an index indicative of a total increase in arrhythmic vulnerability and an index indicative of a rate of increase in arrhythmic vulnerability by comparing the further metric representative of TDR to the first metric representative of TDR and correlating in the external device the index indicative of the total increase in arrhythmic vulnerability and the index indicative of the rate of increase in arrhythmic vulnerability with medication data representative of a medication regimen administered to said patient to identify changes in arrhythmic vulnerability associated with changes in the medication regimen; and

(f) at least one of;

triggering an alert signal on the external device or the implantable medical device if at least one of the index indicative of the total increase in arrhythmic vulnerability or the index indicative of the rate of increase in arrhythmic vulnerability is outside of acceptable bounds defined by one or more thresholds,

displaying on a display of the external device at least one of;

the index indicative of a total increase in arrhythmic vulnerability or correlated index indicative of a total increase in arrhythmic vulnerability and medication data,

recommending with the external device a change in the medication regimen in response to changes in arrhythmic vulnerability associated with the medication regimen, or

automatically adjusting delivery of the medication by a medication pump in response to a change in arrhythmic vulnerability associated with the medication regimen.

2. The method of claim 1, wherein the external device recommends a change in the medication regimen in response to changes in arrhythmic vulnerability associated with the medication regimen.

3. The method of claim 1 wherein the external device recommends that a medication be removed from the medication regimen in response to changes in arrhythmic vulnerability associated with the medication regimen.

4. The method of claim 1 wherein the external device recommends that a dosage of a medication be adjusted in the medication regimen in response to changes in arrhythmic vulnerability associated with the medication regimen.

5. The method of claim 1, wherein:

step (a) further includes storing, within a memory of the implantable system, the first metric representative of TDR generated for the first time period; and

step (b) further includes storing, within the memory of the implantable system, the further metric representative of TDR for the second time period.

6. The method of claim 1, wherein the first time period is triggered in response to a start signal received from outside of the patient and wherein the start signal is received in association with administration of the medication.

7. The method of claim 1, wherein the medication is not an antiarrhythmic medication.

8. The method of claim 1, wherein the external device triggers an alert signal if the index of change in TDR reaches a threshold indicative of the increase in arrhythmic vulnerability being outside of acceptable bounds.

9. The method of claim 1, wherein the medication pump automatically adjusts delivery of the medication in response to a change in arrhythmic vulnerability associated with the medication regimen.

10. The method of claim 1, wherein the one or more attributes of T-waves comprises a complexity of the T-waves.

11. The method of claim 1, wherein the one or more attributes of T-waves comprises an interval from an apex of the T-waves to an end of the T-waves.

12. The method of claim 1, wherein the one or more attributes of T-waves comprises an area under the curve of T-waves.

13. The method of claim 1, wherein the one or more attributes of T-waves analyzed at steps (a) and (b) is/are the same and comprises at least one of an interval from an apex of T-waves to an end of T-waves, an area under the curve of T-waves, or a complexity of T-waves.

14. A method performed by an external device in conjunction with an implantable medical device implanted within a patient, the method comprising:

(a) during a first time period, following administration of a medication, obtaining an electrogram (EGM) signal from a patient via the implantable medical device, and analyzing in the implantable medical device one or more attributes of T-waves of the EGM signal to generate a first metric representative of transmural dispersion of repolarization (TDR);

(b) during a second time period, following the administration of the medication, obtaining a further EGM signal from the patient via the implantable medical device, and analyzing in the implantable medical device one or more attributes of the T-waves of the EGM signal to generate a further metric representative of TDR;

(c) determining in the implantable medical device an index indicative of a total increase in arrhythmic vulnerability and an index indicative of a rate of increase in arrhythmic vulnerability by comparing the further metric representative of TDR to the first metric representative of TDR;

(d) recording in the implantable device the index indicative of a total increase in arrhythmic vulnerability and the index indicative of a rate of increase in arrhythmic vulnerability;

(d) communicating the index indicative of a total increase in arrhythmic vulnerability and the index indicative of a rate of increase in arrhythmic vulnerability from the implantable device to the external device;

(e) comparing in the external device the index indicative of a total increase in arrhythmic vulnerability and the index indicative of a rate of increase in arrhythmic vulnerability with medication data representative of a medication regimen administered to said patient to identify changes in arrhythmic vulnerability associated with changes in the medication regimen; and

(f) at least one of;

displaying data on a display of the external device that identifies changes in arrhythmic vulnerability associated with changes in the medication regimen,

triggering an alert signal on the external device or the implantable medical device if at least one of the index indicative of the total increase in arrhythmic vulnerability or the index indicative of the rate of increase in arrhythmic vulnerability is outside of acceptable bounds defined by one or more thresholds,

recommending with the external device a change in the medication regimen in response to changes in arrhythmic vulnerability associated with the medication regimen, or

automatically adjusting delivery of the medication by a medication pump in response to a change in arrhythmic vulnerability associated with the medication regimen.

15. The method of claim 14, wherein the medication is not an antiarrhythmic medication.

16. The method of claim 14, wherein the external device triggers an alert signal if the index of change in TDR reaches a threshold indicative of the increase in arrhythmic vulnerability being outside of acceptable bounds.

17. The method of claim 14, wherein the one or more attributes of T-waves comprises a complexity of the T-waves.

18. The method of claim 14, wherein the one or more attributes of T-waves comprises an interval from an apex of the T-waves to an end of the T-waves.

19. The method of claim 14, wherein the one or more attributes of T-waves comprises an area under the curve of T-waves.

20. The method of claim 14, wherein the one or more attributes of T-waves analyzed at steps (a) and (b) is/are the same and comprises at least one of an interval from an apex of T-waves to an end of T-waves, an area under the curve of T-waves, or a complexity of T-waves.