Implantable heart stimulation system with automatic mode switching controlled by sympatho-vagal balance

• US 6,477,418 B2
• Filed: 07/11/2001
• Issued: 11/05/2002
• Est. Priority Date: 07/11/2000
• Status: Active Grant

• Current Assignee: Sorin Biomedica Cardio Srl (LivaNova Plc)
• Original Assignee: Sorin Biomedica Cardio Srl (LivaNova Plc)
• Inventors: Vaccarone, Laura, Marcelli, Emanuela, Gaggini, Guido, Plicchi, Gianni, Silvestri, Luigi, Garberoglio, Bruno
• Primary Examiner(s): Getzow, Scott M.
• Application Number:
  US09/903,400
• Publication Number:
  US 20020082661A1
• Time in Patent Office: 482 Days
• Field of Search: 607/9, 607/14
• US Class Current: 607/9
• CPC Class Codes: A61N 1/3622 comprising two or more electrodes co-operating with different heart regions

Abstract

An implantable dual-chamber pacemaker system has a means for automatic beat-to-beat adjustment of the maximum allowable variation (MAV) of the sensed atrial rate (AR) as a function of the sympatho-vagal balance, switching from an atrial tracking mode of operation (e.g., DDD or DDD(R)) to a non atrial tracking mode (e.g., VDI or VDI(R)) when either an arrhythmic tachycardic rate, exceeding the MAV, or a sinus tachycardic rate, exceeding the maximum tracking atrial rate (MTAR), is detected. The pacemaker provides logic means for continuously determining the atrial rate variation (ΔAR) and the MAV. The MAV defines the upper limit for the ΔAR above which tracking is not allowed, discriminating between physiological rate variations and arrhythmic variations. The pacemaker system can return to an atrial tracking mode of operation if the AR remains under a defined rate for a defined number of cycles.

Claims

1. An implantable heart-stimulation system, comprising:

a first sensing element configured to sense atrial signals;

a second sensing element configured to sense ventricular signals;

a pulse generator configured to generate atrial and ventricular stimulating signals; and

a control unit configured to determine for each cardiac cycle an atrial rate from the sensed atrial signals, to determine for each cardiac cycle a maximum allowable variation of the atrial rate as a function of sympatho-vagal balance, and to switch from an atrial tracking pacing mode to a non-atrial tracking pacing mode when a variation in the atrial rate between a first cardiac cycle and a second cardiac cycle exceeds the maximum allowable variation.

2. The system according to claim 1, wherein the sympatho-vagal balance is expressed by heart rate variability.

3. The system according to claim 2, wherein the heart rate variability is measured by means of an index.

4. The system according to claim 3, wherein the index is calculated as the number of atrial intervals, which in a predetermined time interval or number of beats differ from the preceding interval more than a predetermined quantity.

5. The system according to claim 4, wherein the number of beats is 100.

6. The system according to claim 4, wherein the time interval is one minute.

7. The system according to claim 4, wherein the predetermined quantity is 50 milliseconds.

8. The system according to claim 1, wherein the maximum allowable variation of the sensed atrial rate is a positive linear function of an index of the sympatho-vagal balance.

9. The system according to claim 1, wherein the control unit is configured to determine for each cardiac cycle an estimated atrial rate and wherein the control unit is configured to calculate the variation in the atrial rate as the difference between the sensed atrial rate of a present cardiac cycle and the estimated atrial rate of the previous cardiac cycle.

10. The system according to claim 9, wherein the estimated atrial rate is a moving average rate calculated at each cycle.

11. The system according to claim 1, wherein the control unit is programmable.

12. A method of controlling the pacing mode of a heart stimulation system implanted in a patient, the system including first and second sensors for sensing atrial and ventricular signals, a pulse generator for generating and providing atrial and ventricular stimulation pulses to the patient'"'"'s heart and a control unit for controlling the pacing mode of the system, the method comprising:

determining in the control unit an atrial rate of the patient'"'"'s heart from the sensed atrial signals;

determining in the control unit a maximum allowable variation of the atrial rate for each cardiac cycle as a function of sympatho-vagal balance; and

switching from an atrial tracking pacing mode to a non-atrial tracking pacing mode when a variation in atrial rate from a first cardiac cycle to a second cardiac cycle exceeds the maximum allowable variation.

13. The method according to claim 12, wherein, in the step of determining the maximum allowable variation of the atrial rate, the sympatho-vagal balance is expressed by heart rate variability.

14. The method according to claim 13, wherein the heart rate variability is measured by means of an index.

15. The method according to claim 14, wherein the index is calculated as the number of atrial intervals, which in a predetermined time interval or number of beats differ from the preceding interval more than a predetermined quantity.

16. The method according to claim 15, wherein the number of beats is 100.

17. The method according to claim 15, wherein the time interval is one minute.

18. The method according to claim 15, wherein the predetermined quantity is 50 milliseconds.

19. The method according to claim 12, wherein, in the step of determining the maximum allowable variation of the atrial rate, the maximum allowable variation of the sensed atrial rate is a positive linear function of an index of the sympatho-vagal balance.

20. The method according to claim 12, further comprising calculating in the control unit an estimated atrial rate for each cardiac cycle and wherein the variation in atrial rate is calculated as the difference between the sensed atrial rate of a present cardiac cycle and the estimated atrial rate of the previous cardiac cycle.

21. The method according to claim 20, wherein the estimated atrial rate is a moving average rate calculated at each cycle.

22. The method according to claim 12, wherein the control unit is programmable.