1. RYTHMIQTM for INCEPTA™ Episode Based Education

2. RYTHMIQ™ vs. AV SEARCH + Based on IBP Recommendations
RYTHMIQ™ & AV Search + give you options to appropriately manage RV pacing in patients with varying degrees of conduction block
AV Node
Atrial Arrhythmias (if Permanent selected, single chamber mode is recommended)
Feature Recommendations
Normal
None
RYTHMIQ
Paroxysmal/Persistent
1st Degree
2nd Degree
AV SEARCH +
3rd Degree
Paced and Sensed AV Delays
If the AV Node is either Normal or 1st Degree Block, RYTHMIQ will be recommended, unless the Sinus Node is Neurovascular Syndromes. If Atrial Arrhythmias are Paroxysmal / Persistent, RYTHMIQ is still recommended. For patients with second degree conduction block, AV Search+ will be recommended. And for patients with 3rd degree conduction block, Indications Based Programming will recommend Paced and Sensed AV Delays. If Atrial Arrhythmias are permanent or chronic, single chamber mode is recommended.
We know that all patients are not the same, and have different needs with it comes to RV pacing algorithms.
With both RYTHMIQ™ and AV Search + you have options to reduce unnecessary RV pacing for patients with varying degrees of conduction block.
Sinus Node status does not affect IBP recommendations on RYTHMIQ, AV SEARCH + or Paced and Sensed AV Delays, unless Neurovascular Syndromes is selected

3. AV Search +
Allows intrinsic AV conduction beyond programmed AV Delay interval.
During search, AV Delay lengthened to the programmed value for up to 8 cardiac cycles.
Frequency of Search is programmable from consecutive ventricular cycles (paced or sensed).
Up to 8 Search Cycles
The algorithm uses a search during which the AV Delay is lengthened beyond the programmed AV Delay value for up to 8 cardiac cycles. If intrinsic AV conduction is detected, this AV delay extension remains active until two out of ten paced beats . The search itself is programmable from 32 to 1024 consecutive ventricular paced or sensed cycles. 3

4. AV Search + Hysteresis Example
Search initiated after programmed number of consecutive paced or sensed cycles (nominal = 32).
Search concluded after a two ventricular paced cycles within the 10-cycle window.
Successful Search
This EKG example shows the initiation of an AV Search. The extension of the AV delay allows for sensing of the intrinsic ventricular depolarization, and ventricular pacing is inhibited. Two important aspects of the legacy AV Search Hysteresis feature are that the search is initiated after the programmed number of consecutive paced cycles. Ventricular sensed events reset this counter back to zero. Also, when the extended AV delay is active during the search, a single ventricular pacing event returned the device back to the programmed AV delay. With AV Search + , 2/10 paced cycles occur before the switch back to the programmed shorter AV delay. 4

5. AV Search + Two Refinements of the Algorithm
Results
With AV Search Hysteresis, search is initiated after the programmed number of consecutive paced cycles.
AV Search + counts both paced and sensed cycles when determining when to initiate the search.
More frequent searches.
With AV Search Hysteresis, search remains in affect until a single ventricular paced cycle during extension period occurs.
With AV Search +, the search remains in affect until two of ten ventricular paced cycles occur during the extension period.
Will stay at the extension period for longer periods of time.
One refinement of the algorithm is that AV Search + will count both paced and sensed events when determining when to initiate the search. This can result in more frequent searches looking for intrinsic ventricular depolarization.
The second refinement is that when AV Search + is operating with the extended AV delay, it takes two ventricular paced cycles during the last ten beats to end the search and switch back to the shorter programmed AV delay. 5

6. AV Search + Programming
AV Delay Extension with Higher Maximum Tracking Rates
AV Search
AV Search +
Results
AV Delay
= 200 ms
AV Search + operates with longer AV delays over a wider range of patient heart rates.
PVARP
= 250 ms
AV Search Hysteresis
Search Interval
= 32 cycles
AV increase
= 100%
Search AV Delay
= 400 ms
The Maximum Tracking Rate Allowed is
95 bpm
130 bpm
Additionally, the AV Search + algorithm permits AV delay extensions with higher maximum tracking rates. This allows AV Search + to operate with longer AV delays over a wider range of patient heart rates.
For AV Search +, the Maximum Tracking Rate limit is determined by the programmed AV Delay and PVARP (TARP), but the Search AV Delay is allowed to be longer since the rhythm will typically be a conducted ventricular sense following the atrial event. 6

7. RYTHMIQ™ Introducing…RYTHMIQ™
Designed to minimize unnecessary RV pacing without long ventricular pauses
RYTHMIQ is designed to:
Promote intrinsic conduction & reduce unnecessary RV pacing
Operate in AAI(R) pacing mode with VVI backup during times of normal conduction & switch to DDD(R) mode when loss of AV synchrony is detected

8. RYTHMIQTM : Programmer Screens
RYTHMIQ is designed to minimize unnecessary RV pacing without having clinically significant pauses. The operation of this algorithm is very similar to having an AAI or AAIR pacing mode which also has a VVI backup. When conduction block is detected, the algorithm switches to DDD or DDDR mode.
“RYTHMIQ is designed to eliminate unnecessary ventricular pacing for patients who appear to have normal AV conduction, and to prevent clinically significant pauses as defined by the 2008 ACC/AHA/HRS guidelines”1
“RYTHMIQ operates in an AAI(R) pacing mode with VVI backup during times of normal conduction. If loss of AV synchrony is detected, then the mode automatically switches to DDD(R) to restore AV synchrony. If normal conduction returns, then the mode automatically switches back to AAIR with VVI backup. RYTHMIQ does not require dropped ventricular beats to switch to DDD(R) pacing.”1 (bold is added)
1Reference Guide, INCEPTA ICD, Page 4-28, EN US 01/11

9. RYTHMIQTM Operation
“The following occurs during the RYTHMIQ™ stage of AAI(R) with VVI backup:
The device provides AAI(R) at the LRL and/or sensor indicated rate according to the normal brady DDD(R) mode.
The device provides backup VVI pacing at a rate of 15 ppm slower than the LRL. The backup VVI pacing rate is limited to no slower than 30 ppm and no faster than 60 ppm. When there is good conduction, ventricular pacing does not occur as the VVI backup mode runs in the background at a reduced LRL.
The device monitors for loss of AV synchrony. If 3 slow ventricular beats are detected in a window of 11 beats, then the device automatically switches to DDD(R) mode. A slow beat for RYTHMIQ™ is defined as a ventricular pace or ventricular sensed event that is at least 150 ms slower than the AAI(R) pacing rate.”1 The 150 ms value is used to allow for normal variations between cardiac cycles.
RYTHMIQ operates as AAI or AAIR with the VVI backup running in the background. The VVI rate is automatically set at 15 ppm slower than the AAI lower rate, but the VVI rate will be no lower than 30 ppm and no faster than 60 ppm.
The algorithm monitors for loss of AV synchrony which is defined as three slow ventricular beats in a moving window of the last 11 ventricular cycles. A slow ventricular beat for RYTHMIQ is defined as a ventricular paced beat or a ventricular sensed beat that is at least 150 milliseconds slower that the atrial pacing rate. The 150 millisecond value is used to allow for normal variations between the patient’s cardiac cycles.
1Reference Guide, INCEPTA ICD, Page 4-28, EN US 01/11

10. AAI(R) at programmed LRL
RYTHMIQTM Operation – Detecting 3 Slow Ventricular Beats with Atrial Sensor Indicated Rate
AAI(R) at programmed LRL
VVI backup at LRL – 15 ppm,
bounded by [30,60]
Detecting Slow Ventricular Beats and Changing to DDD(R):
Need 3 slow ventricular beats
out of 11 in rolling window defined as:
Ventricular Sense at least 150ms slower than atrial pacing rate (LRL or SIR)
Ventricular Paced beat
NOTES FOR SLIDES 10 – 16
“The following occurs during the RYTHMIQ stage of AAI(R) with VVI backup:
The device provides AAI(R) at the LRL and/or sensor indicated rate according to the normal brady DDD(R) mode.
The device provides backup VVI pacing at a rate of 15 ppm slower than the LRL. The backup VVI pacing rate is limited to no slower than 30 ppm and no faster than 60 ppm. When there is good conduction, ventricular pacing does not occur as the VVI backup mode runs in the background at a reduced LRL.
The device monitors for loss of AV synchrony. If 3 slow ventricular beats are detected in a window of 11 beats, then the device automatically switches to DDD(R) mode. A slow beat for RYTHMIQ is defined as a ventricular pace or ventricular sensed event that is at least 150 ms slower than the AAI(R) pacing rate.”1 The 150 ms value is used to allow for normal variations between cardiac cycles.
“The following occurs during the RYTHMIQ stage of DDD(R):
The device provides DDD(R) pacing according to the normal programmed parameters.
The device uses AV Search+ to periodically check for a return of intrinsic conduction. If AV Search+ remains in AV hysteresis for at least 25 cardiac cycles, and less than 2 of the last 10 cycles are ventricular paced, then the device automatically switches the pacing mode back to AAI (R) with VVI backup.
When RYTHMIQ detects loss of AV synchrony, the device records a RYTHMIQ episode along with 20 seconds of electrogram data (10 seconds before the mode switch, 10 seconds after the mode switch). The RYTHMIQ episode will be noted by the PRM and can be inspected in detail by selecting the appropriate episode from the Arrhythmia Logbook screen. When the DDD(R) stage of RYTHMIQ is active, the RYTHMIQ episode is identified as “in progress”.” 1
1Reference Guide, INCEPTA ICD, Page 4-28, EN US 01/11
Example 1
Reference Guide, INCEPTA ICD, Page 4-28, EN US 01/11

11. RYTHMIQTM Example 1
The atrial lower rate limit is 55 bpm, which then makes the VVI rate limit 55 – 15 bpm, or 40 ppm.
NOTES FOR SLIDES 10-16
“The following occurs during the RYTHMIQ stage of AAI(R) with VVI backup:
The device provides AAI(R) at the LRL and/or sensor indicated rate according to the normal brady DDD(R) mode.
The device provides backup VVI pacing at a rate of 15 ppm slower than the LRL. The backup VVI pacing rate is limited to no slower than 30 ppm and no faster than 60 ppm. When there is good conduction, ventricular pacing does not occur as the VVI backup mode runs in the background at a reduced LRL.
The device monitors for loss of AV synchrony. If 3 slow ventricular beats are detected in a window of 11 beats, then the device automatically switches to DDD(R) mode. A slow beat for RYTHMIQ is defined as a ventricular pace or ventricular sensed event that is at least 150 ms slower than the AAI(R) pacing rate.”1 The 150 ms value is used to allow for normal variations between cardiac cycles.
“The following occurs during the RYTHMIQ stage of DDD(R):
The device provides DDD(R) pacing according to the normal programmed parameters.
The device uses AV Search+ to periodically check for a return of intrinsic conduction. If AV Search+ remains in AV hysteresis for at least 25 cardiac cycles, and less than 2 of the last 10 cycles are ventricular paced, then the device automatically switches the pacing mode back to AAI (R) with VVI backup.
When RYTHMIQ detects loss of AV synchrony, the device records a RYTHMIQ episode along with 20 seconds of electrogram data (10 seconds before the mode switch, 10 seconds after the mode switch). The RYTHMIQ episode will be noted by the PRM and can be inspected in detail by selecting the appropriate episode from the Arrhythmia Logbook screen. When the DDD(R) stage of RYTHMIQ is active, the RYTHMIQ episode is identified as “in progress”.” 1
1Reference Guide, INCEPTA ICD, Page 4-28, EN US 01/11

12. RYTHMIQTM Example 1
A PVC occurs which is not sensed because it falls in the atrial pacing blanking period.
NOTES FOR SLIDES 10-16
“The following occurs during the RYTHMIQ stage of AAI(R) with VVI backup:
The device provides AAI(R) at the LRL and/or sensor indicated rate according to the normal brady DDD(R) mode.
The device provides backup VVI pacing at a rate of 15 ppm slower than the LRL. The backup VVI pacing rate is limited to no slower than 30 ppm and no faster than 60 ppm. When there is good conduction, ventricular pacing does not occur as the VVI backup mode runs in the background at a reduced LRL.
The device monitors for loss of AV synchrony. If 3 slow ventricular beats are detected in a window of 11 beats, then the device automatically switches to DDD(R) mode. A slow beat for RYTHMIQ is defined as a ventricular pace or ventricular sensed event that is at least 150 ms slower than the AAI(R) pacing rate.”1 The 150 ms value is used to allow for normal variations between cardiac cycles.
“The following occurs during the RYTHMIQ stage of DDD(R):
The device provides DDD(R) pacing according to the normal programmed parameters.
The device uses AV Search+ to periodically check for a return of intrinsic conduction. If AV Search+ remains in AV hysteresis for at least 25 cardiac cycles, and less than 2 of the last 10 cycles are ventricular paced, then the device automatically switches the pacing mode back to AAI (R) with VVI backup.
When RYTHMIQ detects loss of AV synchrony, the device records a RYTHMIQ episode along with 20 seconds of electrogram data (10 seconds before the mode switch, 10 seconds after the mode switch). The RYTHMIQ episode will be noted by the PRM and can be inspected in detail by selecting the appropriate episode from the Arrhythmia Logbook screen. When the DDD(R) stage of RYTHMIQ is active, the RYTHMIQ episode is identified as “in progress”.” 1
1Reference Guide, INCEPTA ICD, Page 4-28, EN US 01/11

13. RYTHMIQTM Example 1 Beat 1
Pacing occurs at the VVI lower rate limit of 40 ppm or 1,500 ms. Slow ventricular beat #1.
Beat 1
NOTES FOR SLIDES 10-16
“The following occurs during the RYTHMIQ stage of AAI(R) with VVI backup:
The device provides AAI(R) at the LRL and/or sensor indicated rate according to the normal brady DDD(R) mode.
The device provides backup VVI pacing at a rate of 15 ppm slower than the LRL. The backup VVI pacing rate is limited to no slower than 30 ppm and no faster than 60 ppm. When there is good conduction, ventricular pacing does not occur as the VVI backup mode runs in the background at a reduced LRL.
The device monitors for loss of AV synchrony. If 3 slow ventricular beats are detected in a window of 11 beats, then the device automatically switches to DDD(R) mode. A slow beat for RYTHMIQ is defined as a ventricular pace or ventricular sensed event that is at least 150 ms slower than the AAI(R) pacing rate.”1 The 150 ms value is used to allow for normal variations between cardiac cycles.
“The following occurs during the RYTHMIQ stage of DDD(R):
The device provides DDD(R) pacing according to the normal programmed parameters.
The device uses AV Search+ to periodically check for a return of intrinsic conduction. If AV Search+ remains in AV hysteresis for at least 25 cardiac cycles, and less than 2 of the last 10 cycles are ventricular paced, then the device automatically switches the pacing mode back to AAI (R) with VVI backup.
When RYTHMIQ detects loss of AV synchrony, the device records a RYTHMIQ episode along with 20 seconds of electrogram data (10 seconds before the mode switch, 10 seconds after the mode switch). The RYTHMIQ episode will be noted by the PRM and can be inspected in detail by selecting the appropriate episode from the Arrhythmia Logbook screen. When the DDD(R) stage of RYTHMIQ is active, the RYTHMIQ episode is identified as “in progress”.” 1
1Reference Guide, INCEPTA ICD, Page 4-28, EN US 01/11

14. RYTHMIQTM Example 1 Beat 2
Pacing occurs again at the VVI lower rate limit of 40 ppm or 1,500 ms. Slow ventricular beat #2.
Beat 2
NOTES FOR SLIDES 10-16
“The following occurs during the RYTHMIQ stage of AAI(R) with VVI backup:
The device provides AAI(R) at the LRL and/or sensor indicated rate according to the normal brady DDD(R) mode.
The device provides backup VVI pacing at a rate of 15 ppm slower than the LRL. The backup VVI pacing rate is limited to no slower than 30 ppm and no faster than 60 ppm. When there is good conduction, ventricular pacing does not occur as the VVI backup mode runs in the background at a reduced LRL.
The device monitors for loss of AV synchrony. If 3 slow ventricular beats are detected in a window of 11 beats, then the device automatically switches to DDD(R) mode. A slow beat for RYTHMIQ is defined as a ventricular pace or ventricular sensed event that is at least 150 ms slower than the AAI(R) pacing rate.”1 The 150 ms value is used to allow for normal variations between cardiac cycles.
“The following occurs during the RYTHMIQ stage of DDD(R):
The device provides DDD(R) pacing according to the normal programmed parameters.
The device uses AV Search+ to periodically check for a return of intrinsic conduction. If AV Search+ remains in AV hysteresis for at least 25 cardiac cycles, and less than 2 of the last 10 cycles are ventricular paced, then the device automatically switches the pacing mode back to AAI (R) with VVI backup.
When RYTHMIQ detects loss of AV synchrony, the device records a RYTHMIQ episode along with 20 seconds of electrogram data (10 seconds before the mode switch, 10 seconds after the mode switch). The RYTHMIQ episode will be noted by the PRM and can be inspected in detail by selecting the appropriate episode from the Arrhythmia Logbook screen. When the DDD(R) stage of RYTHMIQ is active, the RYTHMIQ episode is identified as “in progress”.” 1
1Reference Guide, INCEPTA ICD, Page 4-28, EN US 01/11

15. RYTHMIQTM Example 1 Beat 3
A ventricular senses beat then occurs at 1,338 ms, which is slower than the atrial LRL of 55 bpm plus 150 ms (1090 ms ms = 1240 ms). This is slow ventricular beat #3 in the last 11.
Beat 3
NOTES FOR SLIDES 10-16
“The following occurs during the RYTHMIQ stage of AAI(R) with VVI backup:
The device provides AAI(R) at the LRL and/or sensor indicated rate according to the normal brady DDD(R) mode.
The device provides backup VVI pacing at a rate of 15 ppm slower than the LRL. The backup VVI pacing rate is limited to no slower than 30 ppm and no faster than 60 ppm. When there is good conduction, ventricular pacing does not occur as the VVI backup mode runs in the background at a reduced LRL.
The device monitors for loss of AV synchrony. If 3 slow ventricular beats are detected in a window of 11 beats, then the device automatically switches to DDD(R) mode. A slow beat for RYTHMIQ is defined as a ventricular pace or ventricular sensed event that is at least 150 ms slower than the AAI(R) pacing rate.”1 The 150 ms value is used to allow for normal variations between cardiac cycles.
“The following occurs during the RYTHMIQ stage of DDD(R):
The device provides DDD(R) pacing according to the normal programmed parameters.
The device uses AV Search+ to periodically check for a return of intrinsic conduction. If AV Search+ remains in AV hysteresis for at least 25 cardiac cycles, and less than 2 of the last 10 cycles are ventricular paced, then the device automatically switches the pacing mode back to AAI (R) with VVI backup.
When RYTHMIQ detects loss of AV synchrony, the device records a RYTHMIQ episode along with 20 seconds of electrogram data (10 seconds before the mode switch, 10 seconds after the mode switch). The RYTHMIQ episode will be noted by the PRM and can be inspected in detail by selecting the appropriate episode from the Arrhythmia Logbook screen. When the DDD(R) stage of RYTHMIQ is active, the RYTHMIQ episode is identified as “in progress”.” 1
1Reference Guide, INCEPTA ICD, Page 4-28, EN US 01/11

16. RYTHMIQTM Example 1 DDD(R) EGM Stored
RYTHMIQ™ transitions from AAI(R) mode to DDD(R) and an event with electrogram is stored.
DDD(R)
EGM Stored
NOTES FOR SLIDES 10-16
“The following occurs during the RYTHMIQ stage of AAI(R) with VVI backup:
The device provides AAI(R) at the LRL and/or sensor indicated rate according to the normal brady DDD(R) mode.
The device provides backup VVI pacing at a rate of 15 ppm slower than the LRL. The backup VVI pacing rate is limited to no slower than 30 ppm and no faster than 60 ppm. When there is good conduction, ventricular pacing does not occur as the VVI backup mode runs in the background at a reduced LRL.
The device monitors for loss of AV synchrony. If 3 slow ventricular beats are detected in a window of 11 beats, then the device automatically switches to DDD(R) mode. A slow beat for RYTHMIQ is defined as a ventricular pace or ventricular sensed event that is at least 150 ms slower than the AAI(R) pacing rate.”1 The 150 ms value is used to allow for normal variations between cardiac cycles.
“The following occurs during the RYTHMIQ stage of DDD(R):
The device provides DDD(R) pacing according to the normal programmed parameters.
The device uses AV Search+ to periodically check for a return of intrinsic conduction. If AV Search+ remains in AV hysteresis for at least 25 cardiac cycles, and less than 2 of the last 10 cycles are ventricular paced, then the device automatically switches the pacing mode back to AAI (R) with VVI backup.
When RYTHMIQ detects loss of AV synchrony, the device records a RYTHMIQ episode along with 20 seconds of electrogram data (10 seconds before the mode switch, 10 seconds after the mode switch). The RYTHMIQ episode will be noted by the PRM and can be inspected in detail by selecting the appropriate episode from the Arrhythmia Logbook screen. When the DDD(R) stage of RYTHMIQ is active, the RYTHMIQ episode is identified as “in progress”.” 1
1Reference Guide, INCEPTA ICD, Page 4-28, EN US 01/11

17. RYTHMIQTM Operation AAI(R) at programmed LRL
VVI backup at LRL – 15 ppm,
bounded by [30,60]
Sustained conduction
detected
3 slow ventricular beats in moving window of last 11
Declare Event/Record EGM
RYTHMIQ operates in an AAI(R) pacing mode with VVI backup during times of normal conduction. If loss of AV synchrony is detected, then the mode automatically switches to DDD(R) to restore AV synchrony. If normal conduction returns, then the mode automatically switches back to AAIR with VVI backup. RYTHMIQ does not require dropped ventricular beats to switch to DDD(R) pacing.
RYTHMIQ is available only when the normal brady mode is programmed to DDD(R). If the normal brady mode is DDD, then RYTHMIQ can be set to either AAI with VVI backup or Off. If the normal brady mode is DDDR, then RYTHMIQ can be set to either AAIR with VVI backup or Off.
DDD(R) at programmed LRL
Reference Guide, INCEPTA ICD, Page 4-28, EN US 01/11

18. AAI(R) at programmed LRL
RYTHMIQTM Operation
AAI(R) at programmed LRL
VVI backup at LRL – 15 ppm,
bounded by [30,60]
During the RYTHMIQ stage of AAI(R) with VVI backup:
The device provides AAI(R) at the LRL and/or sensor indicated rate.
The device provides backup VVI pacing at a rate of 15 min-1 slower than the LRL. The backup VVI pacing rate is limited to no slower than 30 min-1 and no faster than 60 min-1. When there is good conduction, ventricular pacing does not occur as the VVI backup mode runs in the background at a reduced LRL.
Reference Guide, INCEPTA ICD, Page 4-28, EN US 01/11

19. RYTHMIQTM Operation AAI(R) at programmed LRL
VVI backup at LRL – 15 ppm,
bounded by [30,60]
3 slow ventricular beats in moving window of last 11
Declare Event/Record EGM
The device monitors for loss of AV synchrony.
DDD(R) at programmed LRL
Reference Guide, INCEPTA ICD, Page 4-28, EN US 01/11

20. Detecting slow ventricular beats and changing to DDD(R):
RYTHMIQTM Operation
Detecting slow ventricular beats and changing to DDD(R):
Need 3 slow beats of 11 in rolling window with slow defined as
Ventricular Pace or
Ventricular Sense at least 150ms slower than the indicated atrial pacing rate (LRL or SIR)
AAI(R) at programmed LRL
VVI backup at LRL – 15 ppm,
bounded by [30,60]
3 slow ventricular beats in moving window of last 11
Declare Event/Record EGM
If 3 slow ventricular beats are detected in a window of 11 beats, then the device automatically switches to DDD(R) mode. A slow beat for RYTHMIQ is defined as a ventricular pace or ventricular sensed event that is at least 150 ms slower than the AAI(R) pacing interval.
DDD(R) at programmed LRL
Reference Guide, INCEPTA ICD, Page 4-28, EN US 01/11

21. RYTHMIQTM Operation AAI(R) at programmed LRL
VVI backup at LRL – 15 ppm,
bounded by [30,60]
Sustained conduction
detected
3 slow ventricular beats in moving window of last 11
Declare Event/Record EGM
During the RYTHMIQ stage of DDD(R):
The device provides DDD(R) pacing according to the normal programmed parameters.”
DDD(R) at programmed LRL
Reference Guide, INCEPTA ICD, Page 4-28, EN US 01/11

22. RYTHMIQTM Operation AAI(R) at programmed LRL
VVI backup at LRL – 15 ppm,
bounded by [30,60]
Sustained conduction
detected
Detecting sustained conduction:
AV Search+ activated at programmed settings to periodically check for a return of intrinsic conduction.
CONFIRMATION OF CONDUCTION
AV Search+ remains in AV hysteresis for at least 25 cardiac cycles, and less than 2 of the last 10 cycles are ventricular paced, then switch the pacing mode back to AAI(R) with VVI backup
Conduction
block detected,
Record EGM
The device uses AV Search+ to periodically check for a return of intrinsic conduction. If AV Search+ remains in AV hysteresis for at least 25 cardiac cycles, and less than 2 of the last 10 cycles are ventricular paced, then the device automatically switches the pacing mode back to AAI (R) with VVI backup.
DDD(R) at programmed LRL
Reference Guide, INCEPTA ICD, Page 4-28, EN US 01/11

23. RYTHMIQTM Operation AAI(R) at programmed LRL
VVI backup at LRL – 15 ppm,
bounded by [30,60]
RYTHMIQ can detect
AFib from either AAI(R) or DDD(R)
Sustained conduction
detected
If RYTHMIQ went directly from AAI(R) mode into ATR Mode Switch, when the Mode Switch ends, the algorithm goes directly back into AAI(R) mode.
3 slow ventricular beats in moving window of last 11
Declare Event/Record EGM
DDD(R) at programmed LRL
ATR Mode Switch
Reference Guide, INCEPTA ICD, Page 4-28, EN US 01/11

24. AAI(R) at programmed LRL
RYTHMIQTM Operation – Detecting 3 Slow Ventricular Beats with Atrial Sensor Indicated Rate
AAI(R) at programmed LRL
VVI backup at LRL – 15 ppm,
bounded by [30,60]
Detecting Slow Ventricular Beats and Changing to DDD(R):
Need 3 slow ventricular beats
out of 11 in rolling window defined as:
Ventricular Sense at least 150ms slower than atrial pacing rate (LRL or SIR)
Ventricular Paced beat
“The following occurs during the RYTHMIQ stage of AAI(R) with VVI backup:
The device provides AAI(R) at the LRL and/or sensor indicated rate according to the normal brady DDD(R) mode.
The device provides backup VVI pacing at a rate of 15 ppm slower than the LRL. The backup VVI pacing rate is limited to no slower than 30 ppm and no faster than 60 ppm. When there is good conduction, ventricular pacing does not occur as the VVI backup mode runs in the background at a reduced LRL.
The device monitors for loss of AV synchrony. If 3 slow ventricular beats are detected in a window of 11 beats, then the device automatically switches to DDD(R) mode. A slow beat for RYTHMIQ is defined as a ventricular pace or ventricular sensed event that is at least 150 ms slower than the AAI(R) pacing rate.”1 The 150 ms value is used to allow for normal variations between cardiac cycles.
“The following occurs during the RYTHMIQ stage of DDD(R):
The device provides DDD(R) pacing according to the normal programmed parameters.
The device uses AV Search+ to periodically check for a return of intrinsic conduction. If AV Search+ remains in AV hysteresis for at least 25 cardiac cycles, and less than 2 of the last 10 cycles are ventricular paced, then the device automatically switches the pacing mode back to AAI (R) with VVI backup.
When RYTHMIQ detects loss of AV synchrony, the device records a RYTHMIQ episode along with 20 seconds of electrogram data (10 seconds before the mode switch, 10 seconds after the mode switch). The RYTHMIQ episode will be noted by the PRM and can be inspected in detail by selecting the appropriate episode from the Arrhythmia Logbook screen. When the DDD(R) stage of RYTHMIQ is active, the RYTHMIQ episode is identified as “in progress”.” 1
1Reference Guide, INCEPTA ICD, Page 4-28, EN US 01/11
Example 2
Reference Guide, INCEPTA ICD, Page 4-28, EN US 01/11

25. RYTHMIQTM Example 2
The atrial lower rate limit is 55 bpm, which then makes the VVI rate limit 55 – 15 bpm, or 40 ppm.
“The following occurs during the RYTHMIQ stage of AAI(R) with VVI backup:
The device provides AAI(R) at the LRL and/or sensor indicated rate according to the normal brady DDD(R) mode.
The device provides backup VVI pacing at a rate of 15 ppm slower than the LRL. The backup VVI pacing rate is limited to no slower than 30 ppm and no faster than 60 ppm. When there is good conduction, ventricular pacing does not occur as the VVI backup mode runs in the background at a reduced LRL.
The device monitors for loss of AV synchrony. If 3 slow ventricular beats are detected in a window of 11 beats, then the device automatically switches to DDD(R) mode. A slow beat for RYTHMIQ is defined as a ventricular pace or ventricular sensed event that is at least 150 ms slower than the AAI(R) pacing rate.”1 The 150 ms value is used to allow for normal variations between cardiac cycles.
“The following occurs during the RYTHMIQ stage of DDD(R):
The device provides DDD(R) pacing according to the normal programmed parameters.
The device uses AV Search+ to periodically check for a return of intrinsic conduction. If AV Search+ remains in AV hysteresis for at least 25 cardiac cycles, and less than 2 of the last 10 cycles are ventricular paced, then the device automatically switches the pacing mode back to AAI (R) with VVI backup.
When RYTHMIQ detects loss of AV synchrony, the device records a RYTHMIQ episode along with 20 seconds of electrogram data (10 seconds before the mode switch, 10 seconds after the mode switch). The RYTHMIQ episode will be noted by the PRM and can be inspected in detail by selecting the appropriate episode from the Arrhythmia Logbook screen. When the DDD(R) stage of RYTHMIQ is active, the RYTHMIQ episode is identified as “in progress”.” 1
1Reference Guide, INCEPTA ICD, Page 4-28, EN US 01/11

26. RYTHMIQTM Example 2 Beat 1
A PVC occurs, the next atrial paced event either doesn’t capture, or the atrial event is non-conducted. The following ventricular beat is pacing, resulting in slow beat #1.
Beat 1
“The following occurs during the RYTHMIQ stage of AAI(R) with VVI backup:
The device provides AAI(R) at the LRL and/or sensor indicated rate according to the normal brady DDD(R) mode.
The device provides backup VVI pacing at a rate of 15 ppm slower than the LRL. The backup VVI pacing rate is limited to no slower than 30 ppm and no faster than 60 ppm. When there is good conduction, ventricular pacing does not occur as the VVI backup mode runs in the background at a reduced LRL.
The device monitors for loss of AV synchrony. If 3 slow ventricular beats are detected in a window of 11 beats, then the device automatically switches to DDD(R) mode. A slow beat for RYTHMIQ is defined as a ventricular pace or ventricular sensed event that is at least 150 ms slower than the AAI(R) pacing rate.”1 The 150 ms value is used to allow for normal variations between cardiac cycles.
“The following occurs during the RYTHMIQ stage of DDD(R):
The device provides DDD(R) pacing according to the normal programmed parameters.
The device uses AV Search+ to periodically check for a return of intrinsic conduction. If AV Search+ remains in AV hysteresis for at least 25 cardiac cycles, and less than 2 of the last 10 cycles are ventricular paced, then the device automatically switches the pacing mode back to AAI (R) with VVI backup.
When RYTHMIQ detects loss of AV synchrony, the device records a RYTHMIQ episode along with 20 seconds of electrogram data (10 seconds before the mode switch, 10 seconds after the mode switch). The RYTHMIQ episode will be noted by the PRM and can be inspected in detail by selecting the appropriate episode from the Arrhythmia Logbook screen. When the DDD(R) stage of RYTHMIQ is active, the RYTHMIQ episode is identified as “in progress”.” 1
1Reference Guide, INCEPTA ICD, Page 4-28, EN US 01/11

27. RYTHMIQTM Example 2 Beat 2
Another PVC occurs and the following atrial intrinsic event is non-conducted. The ventricle is then paced at 40 ppm. This is slow beat #2.
Beat 2
“The following occurs during the RYTHMIQ stage of AAI(R) with VVI backup:
The device provides AAI(R) at the LRL and/or sensor indicated rate according to the normal brady DDD(R) mode.
The device provides backup VVI pacing at a rate of 15 ppm slower than the LRL. The backup VVI pacing rate is limited to no slower than 30 ppm and no faster than 60 ppm. When there is good conduction, ventricular pacing does not occur as the VVI backup mode runs in the background at a reduced LRL.
The device monitors for loss of AV synchrony. If 3 slow ventricular beats are detected in a window of 11 beats, then the device automatically switches to DDD(R) mode. A slow beat for RYTHMIQ is defined as a ventricular pace or ventricular sensed event that is at least 150 ms slower than the AAI(R) pacing rate.”1 The 150 ms value is used to allow for normal variations between cardiac cycles.
“The following occurs during the RYTHMIQ stage of DDD(R):
The device provides DDD(R) pacing according to the normal programmed parameters.
The device uses AV Search+ to periodically check for a return of intrinsic conduction. If AV Search+ remains in AV hysteresis for at least 25 cardiac cycles, and less than 2 of the last 10 cycles are ventricular paced, then the device automatically switches the pacing mode back to AAI (R) with VVI backup.
When RYTHMIQ detects loss of AV synchrony, the device records a RYTHMIQ episode along with 20 seconds of electrogram data (10 seconds before the mode switch, 10 seconds after the mode switch). The RYTHMIQ episode will be noted by the PRM and can be inspected in detail by selecting the appropriate episode from the Arrhythmia Logbook screen. When the DDD(R) stage of RYTHMIQ is active, the RYTHMIQ episode is identified as “in progress”.” 1
1Reference Guide, INCEPTA ICD, Page 4-28, EN US 01/11

28. RYTHMIQTM Example 2 Beat 3
Following the second ventricular paced beat, an intrinsic ventricular sensed beat occurs at 1,303 ms, which is slower than the atrial LRL paced interval of 1,090 ms by more than 150 ms.
Beat 3
“The following occurs during the RYTHMIQ stage of AAI(R) with VVI backup:
The device provides AAI(R) at the LRL and/or sensor indicated rate according to the normal brady DDD(R) mode.
The device provides backup VVI pacing at a rate of 15 ppm slower than the LRL. The backup VVI pacing rate is limited to no slower than 30 ppm and no faster than 60 ppm. When there is good conduction, ventricular pacing does not occur as the VVI backup mode runs in the background at a reduced LRL.
The device monitors for loss of AV synchrony. If 3 slow ventricular beats are detected in a window of 11 beats, then the device automatically switches to DDD(R) mode. A slow beat for RYTHMIQ is defined as a ventricular pace or ventricular sensed event that is at least 150 ms slower than the AAI(R) pacing rate.”1 The 150 ms value is used to allow for normal variations between cardiac cycles.
“The following occurs during the RYTHMIQ stage of DDD(R):
The device provides DDD(R) pacing according to the normal programmed parameters.
The device uses AV Search+ to periodically check for a return of intrinsic conduction. If AV Search+ remains in AV hysteresis for at least 25 cardiac cycles, and less than 2 of the last 10 cycles are ventricular paced, then the device automatically switches the pacing mode back to AAI (R) with VVI backup.
When RYTHMIQ detects loss of AV synchrony, the device records a RYTHMIQ episode along with 20 seconds of electrogram data (10 seconds before the mode switch, 10 seconds after the mode switch). The RYTHMIQ episode will be noted by the PRM and can be inspected in detail by selecting the appropriate episode from the Arrhythmia Logbook screen. When the DDD(R) stage of RYTHMIQ is active, the RYTHMIQ episode is identified as “in progress”.” 1
1Reference Guide, INCEPTA ICD, Page 4-28, EN US 01/11

29. RYTHMIQTM Example 2 DDD(R) EGM Stored
Following the “RYTHMIQ” event marker, dual chamber tracking starts.
DDD(R)
EGM Stored
“The following occurs during the RYTHMIQ stage of AAI(R) with VVI backup:
The device provides AAI(R) at the LRL and/or sensor indicated rate according to the normal brady DDD(R) mode.
The device provides backup VVI pacing at a rate of 15 ppm slower than the LRL. The backup VVI pacing rate is limited to no slower than 30 ppm and no faster than 60 ppm. When there is good conduction, ventricular pacing does not occur as the VVI backup mode runs in the background at a reduced LRL.
The device monitors for loss of AV synchrony. If 3 slow ventricular beats are detected in a window of 11 beats, then the device automatically switches to DDD(R) mode. A slow beat for RYTHMIQ is defined as a ventricular pace or ventricular sensed event that is at least 150 ms slower than the AAI(R) pacing rate.”1 The 150 ms value is used to allow for normal variations between cardiac cycles.
“The following occurs during the RYTHMIQ stage of DDD(R):
The device provides DDD(R) pacing according to the normal programmed parameters.
The device uses AV Search+ to periodically check for a return of intrinsic conduction. If AV Search+ remains in AV hysteresis for at least 25 cardiac cycles, and less than 2 of the last 10 cycles are ventricular paced, then the device automatically switches the pacing mode back to AAI (R) with VVI backup.
When RYTHMIQ detects loss of AV synchrony, the device records a RYTHMIQ episode along with 20 seconds of electrogram data (10 seconds before the mode switch, 10 seconds after the mode switch). The RYTHMIQ episode will be noted by the PRM and can be inspected in detail by selecting the appropriate episode from the Arrhythmia Logbook screen. When the DDD(R) stage of RYTHMIQ is active, the RYTHMIQ episode is identified as “in progress”.” 1
1Reference Guide, INCEPTA ICD, Page 4-28, EN US 01/11

30. Further details of ventricular slow beats while in AAIR mode
SIR Rate (bpm)
Ventricular “Slow Beat” (bpm)
Difference in Rates (bpm)
130 97 33
120 92 28
110 86 24
100 79 21 90 73 17 80 66 14 70 59 11 60 52 8 50 44 6 40 36 4
Detecting slow beats and Changing to DDD(R):
Need 3 slow ventricular beats of 11 in rolling window with slow defined as
Ventricular Pace or
Ventricular Sense at least 150ms slower than atrial pacing rate (LRL or SIR)
With the RYTHMIQ algorithm, a slow ventricular beat is either a paced beat, or a ventricular sense at least 150 milliseconds slower than the atrial pacing rate, either the LRL or the sensor-indicated rate if in AAIR.

31. Further details of ventricular slow beats while in AAIR mode
Detecting slow beats and Changing to DDD(R):
Need 3 slow ventricular beats of 11 in rolling window with slow defined as
Ventricular Sense at least 150ms slower than atrial pacing rate (LRL or SIR)
SIR
With the RYTHMIQ algorithm, a slow ventricular beat is either a paced beat, or a ventricular sense at least 150 milliseconds slower than the atrial pacing rate, either the LRL or the sensor-indicated rate if in AAIR.
Slow Ventricular Beats

32. THANK YOU

33. Brief Summary CRT-D Systems from Boston Scientific CRM
Indications and Usage
These Boston Scientific Cardiac Resynchronization Therapy Defibrillators (CRT-Ds) are indicated for patients with heart failure who receive stable optimal pharmacologic therapy (OPT) for heart failure and who meet any one of the following classifications:
Moderate to severe heart failure (NYHA Class III-IV) with EF ≤ 35% and QRS duration ≥ 120 ms
Left bundle branch block (LBBB) with QRS ≥ 130 ms, EF ≤ 30%, and mild (NYHA Class II) ischemic or nonischemic heart failure or asymptomatic (NYHA Class I) ischemic heart failure
Contraindications
There are no contraindications for this device.
Warnings
Read the product labeling thoroughly before implanting the pulse generator to avoid damage to the system. For single patient use only. Do not reuse, reprocess, or resterilize. Program the pulse generator Tachy Mode to Off during implant, explant or postmortem procedures. Always have sterile external and internal defibrillator protection available during implant. Ensure that an external defibrillator and medical personnel skilled in CPR are present during post-implant device testing. Advise patients to seek medical guidance before entering environments that could adversely affect the operation of the active implantable medical device, including areas protected by a warning notice that prevents entry by patients who have a pulse generator. Do not expose a patient to MRI device scanning. Do not subject a patient with an implanted pulse generator to diathermy. Do not use atrial-tracking modes in patients with chronic refractory atrial tachyarrhythmias. Do not use atrial-only modes in patients with heart failure. LV lead dislodgment to a position near the atria can result in atrial oversensing and LV pacing inhibition. Physicians should use medical discretion when implanting this device in patients who present with slow VT. Do not kink, twist or braid the lead with other leads. Do not use defibrillation patch leads with the CRT-D system. Do not use this pulse generator with another pulse generator. For specific models, when using a subpectoral implantation, place the pulse generator with the serial number facing away from the ribs.
For DF4-LLHH or DF4-LLHO leads, use caution handling the lead terminal when the Connector Tool is not present on the lead and do not directly contact the lead terminal with any surgical instruments or electrical connections such as PSA (alligator) clips, ECG connections, forceps, hemostats, and clamps. Do not contact any other portion of the DF4-LLHH or DF4-LLHO lead terminal, other than the terminal pin even when the lead cap is in place.
Precautions
For specific information on precautions, refer to the following sections of the product labeling: clinical considerations; sterilization, storage and handling; implant and device programming; follow-up testing; explant and disposal; environmental and medical therapy hazards; hospital and medical environments; home and occupational environments. Advise patients to avoid sources of electromagnetic interference (EMI) because EMI may cause the pulse generator to deliver inappropriate therapy or inhibit appropriate therapy.
Potential Adverse Events
Potential adverse events from implantation of the CRT-D system include, but are not limited to, the following: allergic/physical/physiologic reaction, death, erosion/migration, fibrillation or other arrhythmias, lead or accessory breakage (fracture/insulation/lead tip), hematoma/seroma, inappropriate or inability to provide therapy (shocks/pacing/sensing), infection, procedure related, and component failure. Patients may develop psychological intolerance to a pulse generator system and may experience fear of shocking, fear of device failure, or imagined shocking. In rare cases severe complications or device failures can occur.
Refer to the product labeling for specific indications, contraindications, warnings/precautions and adverse events. Rx only.
(Rev. P)

34. Brief Summary ICD Systems from Boston Scientific CRM
ICD Indications and Usage
ICDs are intended to provide ventricular antitachycardia pacing and ventricular defibrillation for automated treatment of life-threatening ventricular arrhythmias. ICDs (i.e. Vitality AVT) with atrial therapies are also intended to provide atrial antitachycardia pacing and atrial defibrillation treatment in patients who have or are at risk of developing atrial tachyarrhythmias.
Contraindications
Use of ICD systems are contraindicated in: Patients whose ventricular tachyarrhythmias may have reversible cause, such as 1) digitalis intoxication, 2) electrolyte imbalance, 3) hypoxia, or 4) sepsis, or whose ventricular tachyarrhythmias have a transient cause, such as 1) acute myocardial infarction, 2) electrocution, or 3) drowning. Patients who have a unipolar pacemaker.
Warnings
Read the product labeling thoroughly before implanting the pulse generator to avoid damage to the ICD system. For single patient use only. Do not reuse, reprocess, or resterilize. Program the pulse generator ventricular Tachy Mode to Off during implant, explant or post-mortem procedures. Always have sterile external and internal defibrillator protection available during implant. Ensure that an external defibrillator and medical personnel skilled in cardiopulmonary resuscitation (CPR) are present during post-implant device testing. Patients should seek medical guidance before entering environments that could adversely affect the operation of the active implantable medical device, including areas protected by a warning notice that prevents entry by patients who have a pulse generator. Do not expose a patient to MRI device scanning. Do not subject a patient with an implanted pulse generator to diathermy. Do not use atrial tracking modes (or an AVT device) in patients with chronic refractory atrial tachyarrhythmias (applies to dual-chamber devices only). Do not use this pulse generator with another pulse generator. Do not kink, twist or braid lead with other leads.
For DF4-LLHH or DF4-LLHO leads, use caution handling the lead terminal when the Connector Tool is not present on the lead and do not directly contact the lead terminal with any surgical instruments or electrical connections such as PSA (alligator) clips, ECG connections, forceps, hemostats, and clamps. Do not contact any other portion of the DF4-LLHH or DF4-LLHO lead terminal, other than the terminal pin even when the lead cap is in place.
Precautions
For specific information on precautions, refer to the following sections of the product labeling: clinical considerations; sterilization and storage; implantation; device programming; environmental and medical therapy hazards; hospital and medical environments; home and occupational environments follow-up testing; explant and disposal; post-therapy pulse generator follow-up. Advise patients to avoid sources of electromagnetic interference (EMI).
Potential Adverse Events
Potential adverse events from implantation of the ICD system include, but are not limited to, the following: allergic/physical/physiologic reaction, death, erosion/migration, fibrillation or other arrhythmias, lead or accessory breakage (fracture/insulation/lead tip), hematoma/seroma, inappropriate or inability to provide therapy (shocks/pacing/sensing), infection, procedure related, psychologic intolerance to an ICD system - patients susceptible to frequent shocks despite antiarrhythmic medical management/imagined shocking, and component failure. In rare cases severe complications or device failures can occur.
Refer to the product labeling for specific indications, contraindications, warnings/ precautions and adverse events. Rx only.
(Rev. O)

35. The End