2. Noise, Reset, EGM, Magnet, Advanced Hysteresis

3. Noise Göran Mathson, 2005

4. for internal use only Noise Electromagnetic Interference (EMI) or Noise At least 400 cycles per minute Is very unlikely to be caused by myopotentials

5. for internal use only Noise EMI in Relative Refractory Period of (RRP) initiates a Noise Sampling Window (NSW) NSW is extension of the RRP Noise detected in the Ventricular Channel during DDD / DDI mode operation extends A and V refractory period

6. for internal use only Noise If the Noise persists there will be asynchroneous pacing at the Base Rate (or Sensor Indicated Rate if the Sensor is On) Pacemaker resumes normal operation at the programmed parameters as soon as the Noise stops

7. for internal use only Noise Mode, Atrial Channel PVARP Programmable PVARP Absolute Relative A-A Interval

8. for internal use only 100 ms175 ms Relative Absolute Sensed Event NSW 150 ms Sensed Event NSW 150 ms Noise sampling window (NSW) Sensed Event NSW 150 ms Sensed Event

9. for internal use only Noise Mode, Atrial Channel A-A Interval

10. Reset Göran Mathson, 2005

11. for internal use only Reset When the device has reverted to backup VVI operation, the programmer will display a pop- up message indicating that the device is in back up VVI values. Under most conditions the previously programmed settings can be restored, by following the on-screen instructions.

12. for internal use only Reset parameters

13. Stored Electrograms Göran Mathson, 2005

14. for internal use only Stored Electrograms Programmability Triggers

15. for internal use only Stored Electrograms Stored electrograms are available in the following devices*: Zephyr ® Victory ® Identity ® Integrity ®

16. Stored Electrograms Programmability

17. for internal use only Programmability The device can store a variety of intracardiac configurations for various time frames The following screen shot demonstrates this programmability

18. for internal use only Programmability

19. for internal use only Programmability Sampling Option This parameter determines how the device treats additional Stored EGMs after the allocated memory has been filled Freeze (nominal) Once the device has stored the programmed number of EGMs no more EGMs will be stored Continuous Allows a new Stored EGM to overwrite the oldest Stored EGM First in, First out

20. for internal use only Programmability Number of Stored EGMs Determines how many EGMs the device can store 1, 2, 4, 8, 12 Maximum Duration Calculated by the device based on programmed values

21. for internal use only Programmability Channel Determines what IEGMs will be recorded by the device Programmed Options Atrial Ventricular Dual Cross-Channel (nominal)

22. for internal use only Programmability Channel Atrial When selected, this value will cause an Atrial IEGM to be stored Ventricular When selected, this value will cause a Ventricular IEGM to be stored

23. for internal use only Programmability Channel Dual Both an Atrial and Ventricular IEGM will be stored Cross-Channel Both the Atrial and Ventricular IEGM will be stored on a single electrogram In some patients, this may resemble a surface ECG

24. for internal use only Programmability

25. for internal use only Programmability

26. for internal use only Programmability Atrial EGM Configuration Determines the IEGM to be recorded for the Atrial channel on the Stored EGMs The various configurations can be viewed on the real-time EGM

27. for internal use only Programmability Atrial Dynamic Range Sets the Stored EGM gain for the Atrial channel Programmable Options 15.0, 7.5, 3.0, 1.5 mV (nominal 3.0 mV) These parameters can be previewed on the real-time electrogram

28. for internal use only Programmability Ventricular EGM Configuration Determines the IEGM to be recorded for the Ventricular channel on the Stored EGMs The various configurations can be viewed on the real-time EGM

29. for internal use only Programmability Ventricular Dynamic Range Programmable Options 15.0, 7.5, 3.0, 1.5 mV (nominal 15.0 mV) These parameters can be previewed on the real-time electrogram

30. for internal use only Programmability If AutoCapture™ Pacing Systems is enabled then the Ventricular Configuration is fixed to Vtip-Vring

31. Stored EGMs Stored Electrogram Triggers

32. for internal use only Stored Electrogram Triggers The device can be programmed to automatically store an EGM when triggered by*: Advanced Hysteresis AT/AF Detection High Atrial Rate High Ventricular Rate AMS Entry AMS Exit PVCs PMT Termination Patient Activated / Magnet application * Available triggers depend on the pacemaker model. See device manual.

33. for internal use only Programmability

34. for internal use only Stored Electrogram Triggers Trigger Options Advanced Hysteresis Triggered when Advanced Hysteresis is activated AT/AF Detection Triggered when AT/AF Detection meets programmed criteria High Atrial Rate Off, 175, 200, 225, 250, 275, 300 › No, of Consecutive Cycles -2, 3, 4, 5, 10, 15, 20

35. for internal use only Stored Electrogram Triggers Trigger Options High Ventricular Rate Off, 175, 200, 225, 250, 275, 300 › No, of Consecutive Cycles -2, 3, 4, 5, 10, 15, 20 AMS Entry Triggered when the device enters mode switches AMS Exit Triggered when the device exits mode switches

36. for internal use only Stored Electrogram Triggers Trigger Options PVCs No. of Consecutive PVCs › 2, 3, 4, 5 PMT Termination Patient Activated Magnet Placement (magnet applied for at least 1 sec)

37. for internal use only Stored Electrogram Triggers Additional Considerations Pre-trigger data is collected, approximately 50% of the EGM Some triggers require an associated feature to be active Advanced Hysteresis, AMS Entry, AMS Exit and PMT Termination EGM Storage for High Atrial Rate and AMS Entry and Exit are mutually exclusive Can’t be programmed on together

38. for internal use only Stored Electrogram Triggers Stored EGMs are disabled: When Telemetry is active When Elective Replacement Indicator (ERI), has been achieved

39. for internal use only Impact of SEGM on Victory VictoryDR - 5816 frozen rolling No egm25% egm50% egm100% egm 2.5 V atrium and ventricle, 100% inhibited 17.814.111.68.6 2.5 V atrium, 1.0 V ventricle, 100 % pacing 1310.99.37.3 2.5 V atrium and ventricle, 100% pacing 11.7108.66.8 SR - 5610 frozen rolling No egm25% egm50% egm100% egm 11.48.87.25.2 10.186.74.9 8.87.26.14.6

40. for internal use only Conclusions & Recommendation Field -> Customer Education SEGM in latest SJM pacemakers always records pre-onset the trigger.This may have a significant effect on PG longevity Use SEGM selectively (for example, if episodes are in the log, patient is symptomatic). Consider using Frozen, not continuous, since it is likely to collect SEGM, then turn off, minimizing current drain.

41. Magnet Response Göran Mathson, 2005

42. for internal use only Settings: Off; Battery Test (Nominal: Battery Test) How will the PM respond to the magnet placement Telemetry is disabled when magnet is held over device. Temporarily suspended functions during magnet is held over or Cancelled The Magnet Response

43. for internal use only Terminologie: BOL= Beginning of life EOL = End of life ERT = Elective replacement time ERI = Elective replacement indicator: indication ERT is reached TMT = Threshold margin test: automatic action PM Response: VOO DOO AOO Modus Freq. = indication of batt. Condition Use: Freq. = indication of batt. Condition Troubleshooting – deactivation of algorithms Inhibition of sensing The Magnet Response

44. for internal use only Pacemaker reference guide

45. for internal use only Pacemaker reference guide WWW.SJM.COM Devices For Physicians & Health Care Professionals Implantable Device Reference Guide

46. Neurocardiogenic Syncope Göran Mathson, 2005

47. for internal use only Neurocardiogenic Syncope Common faint also called “Neurally mediated syncope” or “Vasovagal syncope” Young adult, structurally normal heart Malignant vasovagal syncope pacing First line therapy: medication Ineffective and bradycardic component 3 types: Cardioinhibitory, vasodepression and mixed

48. for internal use only Neurocardiogenic Syncope 3 Major Objectives Provide high rate pacing only during the spells Otherwise inhibit the pacemaker Maintain AV Synchrony

49. for internal use only Auto Rate Hysteresis With Search Most patients with Neurocardiogenic Syncope are in sinus rhythm with intact conduction the majority of the time. However, if they have an abrupt drop in rate, they may benefit from an elevated rate of pacing.

50. for internal use only Programmable parameters Hysteresis Rate Programmable Search Interval Programmable Cycle Count Intervention Rate Intervention Duration Recovery Time Advanced Hysteresis Response

51. for internal use only Advanced Hysteresis Response Hysteresis Rate Allows intrinsic activity to be tracked below the base rate Programmable Values: OFF, 30 - 130 in 5 min -1, 140, 150

52. for internal use only Advanced Hysteresis Response Search Interval Allows the device to periodically extend the pacing interval to search for intrinsic activity Programmable Values: OFF, 5, 10, 15, or 30 min.

53. for internal use only Cycle Count The number of intervals the device will extend the pacing interval to search for intrinsic activity. The Cycle Count also serves as the number of cycles the patient’s intrinsic rate will be allowed to drop below the hysteresis rate before pacing at the Intervention Rate begins. Programmable Values: 1-16 cycles Advanced Hysteresis Response

54. for internal use only Advanced Hysteresis Response The rate the pacemaker will operate at if the patients intrinsic rate falls below the Hysteresis Rate for the programmed Cycle Count. It is programmable as a fixed value or as a function of the Intrinsic rate.** Programmable Values: OFF, Base Rate, 80 - 120 (steps of 10 min -1 ), Intrinsic + 0, + 10, +20, +30 min -1 ** The Intrinsic rate is calculated as the average Ventricular Rate over the previous 64 cycles Intervention Rate

55. for internal use only Advanced Hysteresis Response The time in minutes that the pacemaker will operate at the Intervention Rate. Following the Intervention Duration the rate will be decreased, according to the programmed Recovery Time, until either the Base Rate or Sensor Indicated Rate is reached. Programmable Parameters: 1-10 min (steps of 1 min) Intervention Duration

56. for internal use only Advanced Hysteresis Response Programmable Values Fast Medium Slow Very Slow The length of time (in min) that it will take for the pacemaker to reduce the pacing rate from the Intervention Rate to the Base Rate NOTE: This parameter also serves as the setting for the sensor Recovery Time Recovery Time

57. for internal use only Parameter settings for Neurocardiogenic syncope ParameterValueRationale Pacing modeDDD DDI Excer. AV block Rate modulationDISABLEEven no mild levels Base Rate60 -100 bpmSympt. dependent Intervention rate 10 – 20 bpm Above av. rate Av.= intrins.rate before drop Hysteresis rate≤ 45 bpmAsist. >3 sec = 20bpm

58. for internal use only Parameter settings for Neurocardiogenic syncope ParametersValueRationale Rest Rate45 – 50 bpmLower rate at rest Escape Cycles2Persistent slow Cycle Number3Sinus warm up Intervention Duration 2 to 5 minutesThe spells are very brief Recovery TimeMediumSame as sensor AV delaySufficient / VIPVP not needed AutocaptureEnableThreshold rise

59. for internal use only Parameter settings for Neurocardiogenic syncope OFF

60. for internal use only Parameter settings for Neurocardiogenic syncope

61. for internal use only Parameter settings for Neurocardiogenic syncope