Implantable cardiac stimulation device with detection and therapy for patients with vasovagal syncope

• US 6,625,492 B2
• Filed: 05/03/2001
• Issued: 09/23/2003
• Est. Priority Date: 05/15/2000
• Status: Expired due to Fees

• Current Assignee: Pacesetter Incorporated (Abbott Laboratories Incorporated)
• Original Assignee: Pacesetter Incorporated (Abbott Laboratories Incorporated)
• Inventors: Hauck, Gregory, Florio, Joseph J., Bornzin, Gene A.
• Primary Examiner(s): Schaetzle, Kennedy
• Assistant Examiner(s): DROESCH, KRISTEN L
• Application Number:
  US09/849,867
• Publication Number:
  US 20020004672A1
• Time in Patent Office: 873 Days
• Field of Search: 607/2, 607/9, 607/17-19, 607/23-26
• US Class Current: 607/17
• CPC Class Codes: A61N 1/36514 controlled by a physiological quantity other than heart potential, e.g. blood pressure controlled by two or more physical parameters A61N1/36585

Abstract

A pacemaker or other implantable cardiac stimulation device is configured with both a rate hysteresis mode and a vasovagal syncope prevention mode. Within the rate hysteresis mode, the pacemaker detects when the intrinsic heart rate of the patient is below an escape rate, then paces the heart at a Base Rate until an intrinsic beat is detected. When programmed in the vasovagal syncope prevention mode, upon detecting the intrinsic rate falling below the Hysteresis Escape Rate, the pacemaker paces the heart at a Vasovagal Syncope Response Rate, which is considerably higher than the Base Rate. The pacemaker is preferably set to the syncope prevention mode for patients prone to recurrent vasovagal syncope. By pacing the heart at the higher Vasovagal Syncope Response Rate, the pacemaker thereby helps prevent a significant drop in blood pressure which might otherwise cause a loss of consciousness in the patient. System and method embodiments are described.

Claims

1. An implantable cardiac stimulation device having a mode for responding to vasovagal syncope, comprising:

means for defining a programmable Base Rate, a Hysteresis Escape Rate below the Base Rate, and a Vasovagal Syncope Response Rate above the Base Rate;

pulse generating means for generating stimulation pulses at one of the Base Rate, the Hysteresis Escape Rate, and the Vasovagal Syncope Response Rate based on a mode of operation;

sensing means for sensing ventricular cardiac signals and for determining an intrinsic ventricular heart rate;

means for operating the pulse generating means in a Hysteresis Mode using the Hysteresis Escape Rate whenever a ventricular cardiac signal is sensed; and

control means for immediately controlling a rate of stimulation pulses to the heart at the Vasovagal Syncope Response Rate whenever the intrinsic heart rate falls below the Hysteresis Escape Rate.

2. The stimulation device as of claim 1, wherein the control means further comprises:

means for inhibiting the generation of stimulation pulses when the intrinsic ventricular heart rate falls below the Base Rate but above the Hysteresis Escape Rate.

3. The stimulation device as of claim 1, wherein the control means further comprises:

means for defining a Vasovagal Response as a predetermined number of stimulation pulses delivered at the Vasovagal Syncope Response Rate, so as to compensate for the sudden decrease in intrinsic heart rate, followed by a predetermined number of stimulation pulses delivered at successively lower rates as defined by a predetermined recovery rate until the Base Rate is attained.

4. A method for stimulating the heart using an implantable cardiac stimulation device, the method comprising the steps of:

monitoring an intrinsic heart rate of the patient;

determining whether the intrinsic rate falls below a predetermined Hysteresis Escape Rate below a programmed minimum Base Rate; and

generating stimulation pulses in a vasovagal syncope prevention mode whenever the intrinsic rate falls below the predetermined Hysteresis Escape Rate such that the stimulation pulses are immediately delivered to the heart at a Vasovagal Syncope Response Rate which is greater than the Base Rate.

5. The method of claim 4, further comprises the step of:

operating in a inhibiting mode whenever the intrinsic rate falls below the Base Rate but above the predetermined Hysteresis Escape Rate.

6. The method of claim 4, wherein the step of generating stimulation pulses at the Vasovagal Syncope Response Rate is performed for a predetermined Elevated Rate Duration Period.

7. The method of claim 6, wherein the stimulation rate is gradually decreased following the expiration of the Elevated Rate Duration Period until the stimulation rate returns to the Base Rate.

8. The method of claim 7, wherein the stimulation rate is decreased by increasing an interval between consecutive paced beats by a predetermined rate responsive recovery time.

9. The method of claim 4, further comprising the step of:

periodically detecting a peak average intrinsic ventricular rate; and

determining the Vasovagal Syncope Response Rate as a function of the detected peak average intrinsic ventricular rate.

10. The method of claim 9, wherein the step of determining the Vasovagal Syncope Response Rate comprises the step of:

adding an offset to the peak average intrinsic ventricular rate to compensate for the sudden decrease in the intrinsic heart rate.

11. The method of claim 4 further including the step of recording the date and time of the initiation of at least a most recent period of pacing at the Vasovagal Syncope Response Rate.

12. An implantable cardiac stimulation device, comprising:

a sensing circuit that senses an intrinsic heart rate of the patient;

a pulse generator that generates stimulation pulses to the patient'"'"'s heart at a predetermined stimulation rate corresponding to a Base Rate;

a detector capable of detecting when the intrinsic rate falls below a predetermined rate threshold below the Base Rate; and

a controller, responsive to the detector, that triggers the pulse generator to immediately deliver stimulation pulses at a Vasovagal Syncope Response Rate when the intrinsic rate falls below a predetermined rate threshold, the Vasovagal Syncope Response Rate being greater than the Base Rate.

13. The stimulation device of claim 12, wherein:

the detector is further capable of detecting when the intrinsic rate falls within an Hysteresis Escape Rate window, the Hysteresis Escape Rate window being a rate between the Base Rate and the predetermined rate threshold; and

the controller is further capable of inhibiting the pulse generator when the intrinsic rate falls in an Hysteresis Escape Rate window.

14. The stimulation device of claim 12, wherein the controller stimulates the heart at the predetermined Vasovagal Syncope Response Rate for a predetermined Elevated Rate Duration Period.

15. The stimulation device of claim 12, wherein:

subsequent to the elevated rate duration period, the controller gradually decreases the stimulation rate until one of an intrinsic beat is detected or the Base Rate is attained.

16. The stimulation device of claim 15, wherein the controller decreases the stimulation rate by increasing an interval between consecutive paced beats by a predetermined rate responsive recovery time.

17. The stimulation device of claim 12, wherein the controller determines the Vasovagal Syncope Response Rate by periodically detecting a peak average intrinsic ventricular rate and selling the Vasovagal Syncope Response Rate to at least the latest detected peak average intrinsic ventricular rate.

18. The stimulation device of claim 17, wherein the controller determines the peak average intrinsic ventricular rate once every minute.

19. The stimulation device of claim 17, wherein the controller determines the peak average intrinsic ventricular rate each pacing cycle based on the intrinsic ventricular rate for a preceding number of pacing cycles.

20. The stimulation device of claim 12, further including a memory for recording the date and time of the initiation of a most recent period of pacing at the Vasovagal Syncope Response Rate.

21. The stimulation device of claim 12 including a telemetry circuit for receiving programming commands specifying either a rate hysteresis pacing mode or a vasovagal syncope prevention mode.