System and method for treating vasovagal syncope using cardiac pacing

• US 6,788,970 B1
• Filed: 04/24/2002
• Issued: 09/07/2004
• Est. Priority Date: 04/05/2000
• Status: Expired due to Fees

• Current Assignee: Pacesetter Incorporated (Abbott Laboratories Incorporated)
• Original Assignee: Pacesetter Incorporated (Abbott Laboratories Incorporated)
• Inventors: Kadish, Alan H., Falkenberg, Eric, Park, Euljoon
• Primary Examiner(s): Jastrzab, Jeffrey R.
• Application Number:
  US10/132,044
• Time in Patent Office: 867 Days
• Field of Search: 607/9, 607/14, 607/17-25
• US Class Current: 607/17
• CPC Class Codes: A61N 1/368 comprising more than one electrode co-operating with different heart regions A61N1/3622, A61N1/3627 take precedence

Abstract

A pacemaker or other cardiac stimulation device is configured to predict the onset of vasovagal syncope and administers pacing therapy to prevent the syncope from occurring. Prediction of the onset of vasovagal syncope is based upon an analysis of the contractility of the heart muscle. In an example described herein, the contractility of the heart muscle is detected and compared with the average contractility. If the current contractility exceeds the average contractility by a predetermined threshold, a high risk of vasovagal syncope is thereby detected and the heart is paced at a vasovagal syncope prevention rate which may be, for example, 20 to 40 beats per minute faster than a previous heart rate. The contractility of the heart is determined, for example, by measuring the impedance of the heart tissue, by measuring the movement of heart tissue in the wall of the heart, by pressure using an accelerometer, or based on an electrogram signal. The contractility is averaged over a period of time to determine the average contractility.

Claims

1. In an implantable device, a system comprising:

a pulse generator that generates stimulation pulses;

a sensor that senses a parameter corresponding to contractility of a patient'"'"'s heart and that generates corresponding signals; and

a controller, coupled to the sensor and the pulse generator, that processes the signals from the sensor over time to determine an average contractility value and a current contractility value, and wherein the controller is responsive to the current contractility value differing from the average value by at least a predetermined amount to trigger the pulse generator to generate stimulation pulses according to a preventative mode, and wherein the preventative mode excludes drug infusion therapy.

2. The system of claim 1, wherein the sensor comprises a ventricular sensor that senses a signal representative of the contractility of at least one of the patient'"'"'s ventricles.

3. The system of claim 1, wherein the sensor comprises an atrial sensor that senses a signal representative of the contractility of at least one of the patient'"'"'s atria.

4. The system of claim 1, wherein the sensor comprises an impedance sensor that senses at least one of blood impedance, stroke volume, and a change in blood impedance of the patent'"'"'s heart.

5. The system of claim 1, wherein the sensor comprises a motion sensor that detects at least one of heart wall acceleration, velocity, and displacement.

6. The system of claim 1, wherein the sensor comprises a blood pressure sensor.

7. The system of claim 1, wherein the sensor senses the patient'"'"'s intracardiac electrogram signal.

8. The system of claim 7, wherein the sensor further comprises processing circuitry that integrates a portion of the intracardiac electrogram signal corresponding to a depolarization signal following a stimulation pulse.

9. The system of claim 7, wherein the sensor further comprises processing circuitry that is configured to measure the QT interval.

10. The system of claim 7, wherein the sensor further comprises processing circuitry that is configured to measure pre-ejection period.

11. The system of claim 1, wherein:

the controller adjusts a rate of the stimulation pulses according to a predetermined transfer curve.

12. In an implantable device, a system comprising:

a pulse generator that generates stimulation pulses;

a sensor that senses a parameter corresponding to contractility of a patient'"'"'s heart and that generates corresponding signals; and

a controller, coupled to the sensor and the pulse generator, that processes the signals from the sensor over time to determine an average contractility value and a current contractility value, and wherein the controller is responsive to the current contractility value differing from the average value by at least a predetermined amount to trigger the pulse generator to generate stimulation pulses according to a preventataive mode;

wherein the controller adjusts a rate of the stimulation pulses according to a predetermined transfer curve; and

wherein the predetermined transfer curve comprises an incremental increase from a preexisting pacing rate to a predetermined high rate during a first predetermined number of beats, a predetermined high rate during a second predetermined of number of beats, and an incremental decrease in the pacing rate from the predetermined high rate to the preexisting pacing rate during a third predetermined of number of beats.

13. The system of claim 12, wherein the first, second and third predetermined number of beats correspond to a range of 3 to 5 seconds, 30 to 180 seconds, and 10 to 30 seconds, respectively.

14. The system of claim 12, wherein the predetermined high rate is in the range of 20 to 40 beats per minute above the preexisting pacing rate.

15. The system of claim 12, wherein the preexisting pacing rate is a predetermined base pacing rate.

16. The system of claim 12, wherein the preexisting pacing rate is a sensor responsive pacing rate.

17. The system of claim 12, wherein:

the controller determines the predetermined high rate based on the sensed contractility.

18. The system of claim 17, wherein:

the controller dynamically adjusts the predetermined high rate in a closed-loop fashion based on the sensed contractility.

19. In an implantable device, a method for treating vasovagal syncope within a patient, the method comprising:

sensing a parameter corresponding to contractility of the patient'"'"'s heart and generating corresponding signals over time;

processing the signals to determine an average contractility value and a current contractility value; and

generating stimulation pulses at a predetermined rate to overdrive the patient'"'"'s heart rate when the current contractility value differs from the average contractility value by at least a predetermined amount;

wherein the patient'"'"'s heart is overdriven without drug infusion therapy.

20. The method of claim 19, wherein generating comprises:

generating stimulation pulses preemptively before the occurrence of a sudden rate drop associated with vasovagal syncope.

21. The method of claim 19, further comprising determining that there is a significant risk of the onset of vasovagal syncope based upon the current value of the contractility being greater than a predetermined amount from the average contractility value.

22. The method of claim 19, wherein sensing comprises:

sensing a signal representative of the contractility of at least one of the patent'"'"'s ventricles.

23. The method of claim 19, wherein sensing comprises:

sensing a signal representative of the contractility of at least one of the patient'"'"'s atria.

24. The method of claim 19, wherein sensing comprises:

sensing an impedance signal in the patient'"'"'s heart; and

processing the impedance signal to produce at least one of blood impedance, stroke volume, and a change in blood impedance of the patents heart to determine the force of contraction.

25. The method of claim 19, wherein sensing comprises:

detecting cardiac wall motion signal; and

processing the cardiac wall motion signal to produce at least one of heart wall acceleration, velocity and displacement of the patients heart to determine the force of contraction.

26. The method of claim 19, wherein sensing comprises:

sensing a parameter corresponding to the patient'"'"'s blood pressure and generating a corresponding signal; and

processing the signal to determine the force of contraction.

27. The method of claim 19, wherein sensing comprises:

sensing electrogram signals of the patients heart; and

processing the electrogram signal to determine the force of contraction.

28. The method of claim 27, wherein processing the electrogram further comprises:

integrating a depolarization signal that follows a stimulation pulse.

29. The method of claim 27, wherein processing the electrogram further comprises measuring a QT interval.

30. The method of claim 27, wherein processing the electrogram further comprises measuring a pre-ejection period.

31. The method of claim 19, wherein generating comprises:

determining a vasovagal rate based on the sensed contractility signal; and

adjusting from a preexisting rate to the vasovagal rate.

32. In an implantable device, a method for treating vasovagal syncope within a patient, the method comprising:

sensing a parameter corresponding to contractility of the patient'"'"'s heart and generating corresponding signals over time;

processing the signals to determine an average contractility value and a current contractility value; and

generating stimulation pulses at a predetermined rate to overdrive the patient'"'"'s heart rate when the current contractility value differs from the average contractility value by at least a predetermined amount;

wherein generating comprises;

incrementally increasing from a preexisting pacing rate to a predetermined high rate;

maintaining a predetermined high rate for a first predetermined amount of time; and

incrementally decreasing the predetermined high rate to the preexisting pacing rate during a second predetermined amount of time.

33. In an implantable device, a method for treating vasovagal syncope within a patient, the method comprising

sensing a parameter corresponding to contractility of the patient'"'"'s heart and generating corresponding signals over time;

processing the signals to determine an average contractility value and a current contractility value; and

generating stimulation pulses at a predetermined rate to overdrive the patient'"'"'s heart rate when the current contractility value differs from the average contractility value by at least a predetermined amount;

wherein generating comprises;

incrementally increasing from a preexisting pacing rate to a predetermined high rate during a first predetermined on number of beats;

maintaining a predetermined high rate during a second predetermined on number of beats; and

incrementally decreasing from the predetermined high rate to the preexisting pacing rate during a third predetermined on number of beats.

34. In an implantable device, a system for treating vasovagal syncope within a patient the system comprising:

pulse generating means for generating stimulation pulses;

physiological sensing means for sensing a parameter corresponding to contractility of the patient'"'"'s heart;

means for determining an average contractility value and a current contractility value;

means for determining if the current contractility value differs from the average contractility value by at least a predetermined amount; and

means for triggering the pulse generating means to generate stimulation pulses at a predetermined rate so as to overdrive the intrinsic heart rate;

wherein the intrinsic heart rate is overdriven without drug infusion therapy.

35. The system of claim 34, wherein the physiological sensing means comprises:

means for sensing a signal representative of the contractility of at least one of the patient'"'"'s ventricles.

36. The system of claim 34, wherein the physiological sensing means comprises:

means for sensing a signal representative of the contractility of at least one of the patient'"'"'s atria.

37. The system of claim 34, herein the physiological sensing means comprises:

impedance measuring means for measuring an impedance corresponding to at least one of blood impedance, stroke volume and a change in blood impedance of the patients heart.

38. The system of claim 34, wherein the physiological sensing means comprises:

motion detecting means for detecting cardiac wall motion corresponding to at least one of heart wall acceleration, velocity and displacement.

39. The system of claim 34, wherein the physiological sensing means comprises means for sensing blood pressure.

40. The system of claim 34, wherein the physiological sensing means comprises electrogram sensing means for sensing intracardiac electrogram signals of the patient'"'"'s heart.

41. The system of claim 40, wherein the electrogram sensing means comprises means for integrating the depolarization portion of the electrogram.

42. The system of claim 40, wherein the electrogram sensing means comprises means for determining the QT interval.

43. The system of claim 40, wherein the electrogram sensing means comprises means for determining pre-ejection period.

44. The system of claim 40, wherein the means for triggering comprises:

means for adjusting a current pacing rate to a predetermined high rate;

means for providing stimulation pulses at a predetermined high rate for a first predetermined time period; and

means for adjusting the predetermined high rate to a base rate for a second predetermined time period.

45. The system of claim 34, wherein the means for triggering comprises:

means for adjusting a current pacing rate to a rate that reduces the contractility signal to the average value.

46. In an implantable device, a system comprising:

a pulse generator that generates stimulation pulses;

a cardiac impedance sensor that senses cardiac impedance values and generates corresponding signals; and

a controller, coupled to the cardiac impedance sensor and the pulse generator, that processes the signals from the cardiac impedance sensor to determine whether there is a risk of an onset of vasovagal syncope, and that triggers the pulse generator to generate stimulation pulses at a predetermined rate if the risk exists;

wherein the stimulation pulses at the predetermined rate are generated without infusion of a drug.

47. The system of claim 46, wherein the sensor comprises a ventricular sensor that senses a signal representative of the contractility of at least one of the patient'"'"'s ventricles.

48. The system of claim 46, wherein the sensor comprises an atrial sensor that senses a signal representative of the contractility of at least one of the patient'"'"'s atria.

49. The system of claim 46, wherein the controller is operative to trigger the pulse generator to generate stimulation pulses at an overdrive pacing rate.

50. In an implantable device, a method for treating vasovagal syncope within a patient, the method comprising;

sensing cardiac impedance values of the patient'"'"'s heart and generating corresponding signals over time;

processing the signals to determine whether there is a risk of an onset of vasovagal syncope; and

generating stimulation pulses at a predetermined rate if the risk exists;

wherein the stimulation pulses at the predetermined rate are generated without infusion of a drug.