2. ACap™ Confirm

3. ACap™ Confirm Benefits
Automatic algorithm to adjust the atrial pacing amplitude to address changing atrial thresholds
Clinic time saved by daily automatic atrial amplitude testing and adjustment (8 – 23 hrs)
Threshold trend with follow-up EGMs to quickly evaluate patients status
Evaluate early lead integrity issues

4. ACap™ Confirm What to do
At activation
Run Setup Test
Run Capture Test
At follow-up
Read ACap™ Confirm results and trend

5. ACap™ Confirm Polarity
Bipolar pacing
Uni- or bipolar sensing
ER detection always unipolar
Uni- or bipolar back-up pulse configuration

6. ACap™ Confirm
Setup

7. ACap™ Confirm Setup
The ER will be determined during the ACap™ Confirm Setup using Paced Depolarization Integral (PDI)

8. ACap™ Confirm Determine ER sensitivity
Ensures ER is large enough to separate from polarization
Captured pulses = ER + Polarization
Non-captured pulses = Polarization Only
ER sensitivity is automatically set to a safe level between ER & polarization measurements

9. ACap™ Confirm How the Setup Test is Run
test rate 90 bpm default (max 120 bpm)
4 paced beats at each amplitude
1-2 beats between for program changes
4.5
4.25
4.0
3.75
3.5
3.0
2.5
2.0
1.5
1.0
0.75
0.5
0.25
0.0
Back up pulse, 5.0 V, is delivered after primary pulse on non captured 0.75V)

10. ACap™ Confirm Setup Test, Back-up pulse
40 ms after primary pulse
5.0 V, >0.5 ms
unipolar or bipolar

11. ACap™ Confirm Setup Test, AV Delay
180
120
AV delay as programmed as long as capture in Setup Test
Test dictates AV delay 120 ms when backup pulse is delivered
(timed from primary atrial pulse)

12. ACap™ Confirm Evoked Response detection
Blanking
Sensing
(Alert)
4.5 ms
31ms
PDI-area of ER in A. unipolar tip EGM channel
PDI Paced Depolarization Integral
ER Evoked Response

13. ACap™ Confirm Programmable Options
On A voltage is added to the threshold to define a new automatic pulse amplitude to be used until the next search (requires a 1.7:1 safety margin)
Monitor Capture threshold is automatically measured and plotted on the trend but no automatic amplitude adjustment is made
Off No measurements performed no weekly threshold trend data available

14. ACap™ Confirm Capture - Loss of Capture
Capture Confirmed
Loss of Capture
ER Sensitivity = 500
PDI = 750
ER Sensitivity = 500
PDI = 150

15. ACap™ Confirm
Capture Test

16. ACap™ Confirm How the Capture Test is Run (Capture @ 0.825V)
Ensure atrial pacing: in-clinic test rate 90 bpm default (max 120 bpm)
4 paced beats at each amplitude
Decrease amplitude in 0.25 V steps. 3 Consecutive pulses at the same amplitude confirm LOC (backup pulse delivered)
Increase amplitude in V steps until 2 consecutive pulses capture at the same amplitude (capture threshold)
Back up pulse, 5.0 V, is delivered after every primary pulse on non captured events

17. ACap™ Confirm How the Capture Test is Run (Capture @ 0.825V)
2.0
1.75
1.825
1.5
1.25
1.0
0.825
0.75

18. ACap™ Confirm Capture Test
Starts at programmed atrial pulse amplitude
If programmed atrial pulse amplitude > V start the threshold search at V
Decrease amplitude in 0.25 V steps until 3 consecutive pulses at the same amplitude confirm LOC (backup pulse delivered). Below 0.25 V, the step size is V
Increase amplitude in V steps until 2 consecutive pulses capture at the same amplitude (capture threshold)

19. ACap™ Confirm Safety Margin
To 5.0V
To 5.0V
To 5.0V
To 5.0V
To 5.0V
+2.0V
+2.0V
+1.5V
+1.0V
+1.0V
+1.0V
+1.0V
+1.0V
N/A
4.5
4.25
4.0
3.75
3.5
3.0
2.5
2.0
1.5
1.0
0.75
0.5
0.25
0.0
Adding safety margin related to capture threshold

20. ACap™ Confirm Safety Margin

21. ACap™ Confirm
Out of Clinic Test

22. ACap™ Confirm Periodic Out of Clinic Threshold Search
Programmable: 8 or 24 (23) hrs
Device overdrives the atrial rate
Minimize fusion
Maximize patient comfort by interspersing atrial test pulses throughout normal pacing

23. Threshold Search Algorithm
Monitoring Period
Search initiation: open window of 16 atrial intervals
Determine the rate overdrive interval for atrial test pulses
16 pulses should cover two respiratory cycles
Continuously update rate overdrive interval
Fusion avoidance

24. Threshold Search Algorithm Out of Clinic Periodic Threshold Search
Test Mode
Conditions under which test occurs
Fast
100% Atrial paced during monitoring period and one of
AF Suppression Off
AF Suppression On, but not actively overdriving
Slow
At least one p-wave during monitoring period and one of
AF Suppression
AF Suppression On and
AF Suppression actively overdriving rate

25. Threshold Search Algorithm
Fast Mode
100% atrial pacing during monitoring period
(AF Suppression is OFF or not actively overdriving)

26. Threshold Search (Fast) AF Suppression OFF or Not Actively Overdriving
Search initiation: 16 beat monitoring period
100% atrial pacing in monitoring period: AF supression off / no AF related atrial pacing
Test pulse overdrive interval:
Current pacing interval – 40 ms
If another algorithm calculates a shorter interval than the test pulse overdrive interval, i.e.- Rate Response, the shorter interval is used
Overdrive rate limit is 120 bpm

27. ACap™ Confirm How the Fast Mode is Run (Capture @ 0.825V)
Only Paced Events
Monitoring, 16 beats
2.0
Monitoring, 16 beats
Monitoring, 16 beats
Monitoring, 16 beats
1.75
1.875
1.5
1.25
1.0
0.75
0.75
0.75
0.875
5.0
5.0
5.0
0.875

28. Threshold Search (Fast) cont’d
Question
What if a p-wave were sensed during the threshold test?
Answer
A new 16 beat monitoring period would begin

29. ACap™ Confirm Sensing interrupts the test
FAST MODE
Intrinsic event
Restart of monitoring
0.75
2.0
1.75
1.25
1.5
1.0
0.875
1.875
Monitoring, 16 beats
5.0
I N T R I N S I C

30. Threshold Search Algorithm
Slow Mode
at least one atrial event is sensed during monitoring period
(AF Suppression is OFF or not actively overdriving)

31. Threshold Search (Slow) AF suppression OFF - Not Actively Overdriving
Search initiation: 16 beat monitoring period
At least one sensed P- wave occurs during monitoring period
Test pulse interval = MATRI - the max of either
3 x ARIAD
40 ms

32. Threshold Search (Slow) AF suppression OFF - Not Actively Overdriving
Test pulse interval = MATRI - the max of either
a) 3 x ARIAD
b) 40 ms
MATRI
Mean ATrial Rate Interval (from monitoring period, 16 atrial intervals)
ARIAD
Atrial Rate Interval Average Deviation (during monitoring period) Disregard the two shortest as well as the 6 longest intervals, then calculate the average deviation on the remaining 8 intervals

33. Threshold Search (Slow) AF Suppression OFF - Not Actively Overdriving
Rate Observation Period (Slow Mode)
Started after 16 beat monitoring period
10 cycles in duration
Look for a long atrial interval, ≥ MATRI (mean atrial rate interval)
Following long interval, deliver test pulse at test pulse interval
If a long atrial interval is not seen within 10 cycles:
Test pulse is not delivered
New 16 beat monitoring period is started

34. ACap™ Confirm (Slow) Monitoring and Rate Observation Period
LONG INTERVAL
956ms
972ms
986ms
Rate Observation <10 beats Test Pulse following a long interval > MATRI
902ms
Test Pulse Rate interval
MATRI – (3xARIAD (or 40ms))
977 – (3x25)ms = 902 (67 min-1)
Monitoring, 16 beats
I N T R I N S I C
I N T R I N S I C
I N T R I N S I C
I N T R I N S I C
I N T R I N S I C
I N T R I N S I C
I N T R I N S I C
I N T R I N S I C
Interval
Variation from mean value
1000ms
23ms
892ms
85ms
923ms
54ms
952ms
25ms
968ms
9ms
898ms
79ms
Mean ATrial Rate Interval (MATRI) = 977 ms
Atrial Rate Interval Average Deviation (ARIAD) = 25 ms
1000ms
1000ms
1000ms
1000ms
1000ms
1000ms

35. Threshold Search (Slow) AF suppression OFF - Not Actively Overdriving
New monitoring period is started after test pulse delivery
If no atrial events are sensed in alert during monitoring period, search switches to Fast Mode
Test proceeds as described before
Attempt test pulse delivery in the first cycle after long atrial interval
Test pulse delivery is inhibited by a sensed atrial event
New monitoring period would be started

36. ACap™ Confirm How the Slow Mode is Run
Calculate mean
atrial rate
interval (MATRI)
and atrial rate
interval deviation
(ARIAD)
No long atrial interval is seen within 10 cycles
Rate Observation Period
New Monitoring Period
p-waves
Calculate MATRI
and ARIAD
Rate Observation Period
test pulse after
long interval
New Monitoring Period
No p-waves
Fast-mode
p-wave during
threshold test
Initiates new
monitoring period
New Monitoring Period
No p-waves
Fast-mode
2.0
2.0
1.75
I N T R I N S I C
I N T R I N S I C
I N T R I N S I C
I N T R I N S I C
I N T R I N S I C
I N T R I N S I C
I N T R I N S I C
I N T R I N S I C
I N T R I N S I C
I N T R I N S I C
I N T R I N S I C
I N T R I N S I C
I N T R I N S I C
I N T R I N S I C
I N T R I N S I C
I N T R I N S I C
I N T R I N S I C
I N T R I N S I C
I N T R I N S I C
LONG INTERVAL
I N T R I N S I C
1.5
1.25
1.0
0.75
Monitoring, 16 beats
5.0

37. ACap™ Confirm How the Slow Mode is Run
Calculate mean
atrial rate
interval (MATRI)
and atrial rate
interval deviation
(ARIAD)
Test pulse interval
MATRI minus
the max of either: 3 x ARIAD or 40 ms
0.75
2.0
1.75
1.25
1.5
1.0
0.875
1.875
Monitoring, 16 beats
5.0
I N T R I N S I C
LONG INTERVAL

38. ACap™ Confirm How the Slow Mode is Run
Calculate mean
atrial rate
interval (MATRI)
and atrial rate
interval deviation
(ARIAD)
Test pulse interval
MATRI minus
the max of either: 3 x ARIAD or 40 ms
Test pulse delivery
is inhibited
by a sensed
atrial event.
New monitoring
period would
be started
0.75
1.75
1.25
1.5
1.0
0.875
1.875
Monitoring, 16 beats
5.0
I N T R I N S I C
2.0
LONG INTERVAL

39. ACap™ Confirm How the Slow Mode is Run. (Capture @ 0.825V)
Calculate mean
atrial rate
interval (MATRI)
and atrial rate
interval deviation
(ARIAD)
Test pulse interval
MATRI minus
the max of either: 3 x ARIAD or 40 ms
2.0
2.0
2.0
Monitoring, 16 beats
1.75
I N T R I N S I C
I N T R I N S I C
I N T R I N S I C
I N T R I N S I C
I N T R I N S I C
LONG INTERVAL
I N T R I N S I C
LONG INTERVAL
I N T R I N S I C
1.5
1.25
1.0
0.75
Monitoring, 16 beats
5.0

40. Threshold Search Algorithm
AF suppression Mode
AF Suppression ON and Actively Overdriving

41. Threshold Search AF Suppression Mode Search (ON and Actively Overdriving)
During AF Suppression overdrive, No monitoring periods are started after:
Test pulses
Test pulse inhibition
Back-up pulses
If AF Suppression stops overdriving, a new monitoring period is started.
If no atrial events are sensed → Fast Mode.
If at least one atrial event is sensed → Slow Mode

42. Threshold Search AF Suppression Mode Search (ON and Actively Overdriving)
Second overdrive
stimulus is a
test pulse @ AF Suppression rate interval
Max. AF Suppression Rate
Second overdrive
stimulus is a
test pulse @ AF Suppression rate interval
Second overdrive
stimulus is a
test pulse @ AF Suppression rate interval
AFx
Intrinsic Rate
Basic Rate

43. ACap™ Confirm
Threshold Search Interactions

44. ACap™ Confirm Threshold Search Interactions
Ongoing ACap Confirm threshold search is terminated upon wand placement
Search is reinitiated upon wand removal
If an automatic ACap Confirm threshold search is scheduled to start while wand is in place:
Search delayed until wand is removed
If weekly trend log is scheduled to be logged, it will be logged upon wand removal

45. ACap™ Confirm Threshold Search Interactions
If AMS entry occurs during a threshold search the algorithm is suspended until one hour after AMS exit
Atrial threshold search is suspended/delayed until the following processes are complete
Automatic P and R-wave measurements
Lead surveillance
Actively storing a SEGMs
Ventricular AutoCapture threshold

46. ACap™ Confirm Threshold Search Exceptions
Amplitude is set to 5.0 V (high output) if:
Capture verification occurred at 0.0 V
Amplitude increases to V and capture fails
If ACap Confirm goes to High Output Mode, a new threshold search will be performed after one hour
If capture threshold fails or is inhibited a new threshold search may be re-initiated in one hour, 8 or 24 hour clock is not reset
If the atrial rate >120 bpm the threshold search will be canceled and attempted in 1 hour

47. ACap™ Confirm High Output Mode
High Output Mode popup message when:
ACap Confirm is at maximum output
ACap Confirm has been auto-programmed to OFF and the atrial pulse amplitude has been set to 5.0 V
High Output Mode popup message when ACC is Monitor:
ACap Confirm could not determine the threshold
Are these for in-clinic measurements only?
Does it really program it off after 1 HOM determination? Because next slide says that it will try again in 1 hour.

48. ACap™ Confirm Interactions
If an Atrial lead configuration switch occurs:
ACap Confirm in Monitor Mode:
ACap Confirm is turned OFF (Atrial pulse amplitude remains at programmed value)
If ACap ConfirmON:
ACap Confirm is turned OFF (Atrial pulse amplitude is set to 5.0 V. Pulse width unchanged

49. ACap™ Confirm Interactions
At ERI, if ACC mode is ON
ACC is programmed OFF
Pulse amplitude is set to 2 x (average of 4 most recent atrial capture thresholds), minimum 2.0 – maximum 5.0 V
At ERI, if ACC mode is Monitor
Pulse amplitude remains at programmed value

50. ACap™ Confirm Summary
ACap™ Confirm Setup Test prior to enabling the algorithm
Periodic threshold searches and amplitude adjustments
Programmable Modes: Off, On and Monitor
Follow-up EGMs and trend data available

51. ACC and VAC Differences
V. AutoCapture
ACap Confirm
Threshold search, no beat to beat capture verification or capture recovery
Threshold search, beat to beat capture verification
Capture detection: PDI method
Capture detection: PDI and DMAX method
Fusion Avoidance -Rate overdrive
Fusion Avoidance - Short AV delay
40 ms backup (5.0V)
100 ms backup (5.0V)
3 consecutive LOCs to confirm LOC
2 consecutive LOCs to confirm LOC
Programmable “ON” option allows amplitude adjustment after search capture
Amplitude adjusted after search
Output set to defined safety margin (1.7:1)
Output set to threshold V margin