1. Integrated Therapy
Warren Klibbe
Marketing Manager CRM

2. The Philos II pacemaker family
Philos II S has also the CE Mark, but will not be produced 2

3. Philos II overview Auto-Initialization Implantation IRSplus
Active capture control (ACC)
Therapy
Mode switching overdrive pacing
Effective & efficient workflow
Rate fading
Broadband IEGM recordings
Follow-up
Follow-up
Home Monitoring 3

4. Implant confirmation time
Auto-initialisation
Implant confirmation time
30 min
Lead detection
polarity selection
Diagnostic
memory
Mode switching
PMT management
Function activation
Threshold monitoring 4

5. Active capture control
Maximum safety
104 patients, 41 Holters, FDA
No pauses
100% capture with backup pulse
1 year lifetime extension*
No explicit lead limitation
Works in uni & bipolar configuration
*Calculated using a mean V amplitude reduction of 2.0 V 5

6. Easy and efficient use – active capture control
Intelligent details deliver superiority
Fusion discrimination reduces ventricular pacing
Back-up pulse with increased width offers protection from phrenic nerve stimulation assuring maximum energy efficacy
Single button activation 6

7. Active capture control
3 components of ACC algorithm
ACC
at each periodically periodically pace
Active threshold monitoring ATM
Signal-analysis
Threshold search
Adjust-ment of the pacing amplitude
Capture control
successful
successful 7

8. Active capture control
Signal check
Determinates whether evoked response and polarization artifact are acceptable
Pacing with capture
Pacing without capture
Polarisation- artefact
Polarisation- artefact
Evoked response 8

9. Active capture control
Signal analysis
In the first 5 paces - analysis of the evoked response together with polarisation artefact
In the second step, 2 coupled paces (100 ms interval) are applied for five cycles. Based on the in-effective second pace, the maximum polarisation artefact can be determined 9

10. Active capture control (ACC)
Automatic threshold measurement
The ventricular threshold is measured periodically and the stimulation amplitude is adapted
The measurement starts with the programmed “maximum amplitude“
Output amplitudes are reduced in larger decriments at the beginning, and finally in smaller steps. Each decrimented amplitude has 2 pulses.
A back-up pace with higher energy is delivered in the event of NO capture
If non-capture is still indicated with a pacing amplitude of 0.1 Volt, than the threshold-test is declareded as “not succesful“ 10

11. Active capture control
Automatic threshold measurement
Back-up Pules ms
Example
Maximum ACC amplitude = 2.4 V
Safety margin = 0.5 V
Threshold = 0.9 V
2.4 V
2.1 V
1.8 V
1.6 V
1.4 V
1.2 V
1.0 V
0.9 V
0.8 V
1.4 V 11

12. Active capture control
Amplitude steps during threshold measurement
... 17
0.9 16
1.0 15
1.1 14
1.3 13
1.5 12
1.7
1.2 11
1.9
1.4 10
2.2
1.6 9
2.5
1.8 8
2.9
2.1 7
3.3
2.4 6
3.8
2.8 5
4.3
3.2 4
4.9
3.7
2.7 3
5.6
4.2
3.1 2
6.4
4.8
3.6 1
Amplitude Steps
(if capture is not lost during test)
Maximum
ACC
Amplitude
Note: below 1.0 V the step is always 0.1V 12

13. Active capture control
Continuous capture confirmation
Continuous beat-by-beat testing to ensure effective pacing
In case of no capture:  Back-up pace with increased energy
In case of loss of capture (a sequence of non-capture):  Start of a new threshold measurement 13

14. Active capture control
The back-up pulse
Detection of
evoked response
60 ms
Ventricular blanking
20 ms
Calculation, programming
50 ms
131 ms
Ventricular pace
actual amplitude with 0.4 ms non-capture
Back-up pace
actual amplitude with 1.0 ms capture 14

15. Active capture control
Automatic, periodic measurement of ventricular pacing threshold
Beat-by-beat capture confirmation
Back-up pulse upon detection of non-capture
Automatic reprogramming of pulse amplitude
Comprehensive diagnostics 15

16. Active capture control
Available statistics for ACC 16

17. Follow up: Automatic threshold test
Fast and automatic determination of the ventricular threshold
100% security due to effective backup pacing assuring ventricular support 17

18. Active capture control
Programming 18

19. FDA feasibility trial Philos II ACC19

20. Broadband IEGM recording
Storage of up to 12 IEGM recordings
Recording of unfiltered atrial and ventricular IEGM’s and marker channel
Recording of 7.5 seconds before and 2.5 seconds after the trigger
Broadband signal resolution: 128 Hz 20

21. Broadband IEGM recording
No marker signal correlation
Reduced specificity of mode switching due to intermittent farfield sensing 21

22. Automatic IEGM recordings
Intelligent memory management
Examples
First Mode Switching event
Mode Switching event with the highest ventricular rate
Episode with the longest duration of mode switching
Event with the highest ventricular rate
Episode with the longest duration of a high ventricular rate 1 2 3 4 5
12 event memories (of approx 10 seconds each)
Intelligent memory management, NOT “First-In First-Out“
Clinically relevant events are not overwritten 22

23. Broadband IEGM recording
Appropriate mode switch due to AF
Optimal correlation: marker and event 23

24. AT/AES classification
P-P interval A V
Prematurity (e.g., 25%)
AVI
AARP
AESW
Information about the origin and classification of AT
Therapy verification
Possibility to verify antitachycardia therapies 24

25. Follow-up
Storage of follow-up data in the pacemaker 25

26. Home Monitoring Home Monitoring principle
1. Patient has an implant with Home Monitoring option
2. CardioMessenger
relays on daily basis an SMS (and additional messages if needed)
4. Physician with a secured internet
entry
3. Automatic data analysis in the service center 26

27. Home Monitoring
The antenna 27

28. Rate Fading (Rate smoothing)
Purpose of rate fading
Prevention of an in-appropriate rate decrease:
For example, in patients with exercise induced bradycardia
After mode-switching
Prevention of symptoms related to sudden rate drop 28

29. Rate fading Terminology Back-up rate: Effective pacing rate
Target rate: Calculated rate
(mean detected rate)
RF-increase: Speed of adaptation of the back-up rate towards a higher target rate
RF-decrease: Speed of adaptation of the back-up rate towards a lower target rate 29

30. Rate fading Rate fading at sudden rate drop of intrinsic heart rate
10 bpm 30

31. Rate fading Intrinsic Rate Target Rate Back-up Rate Basic Rate
Increasing the Back-up Rate for 2 bpm / cycle (example)
Reduction of the Back-up Rate for 0,5 bpm/cycle (example)
10 ppm
Basic Rate
4 Cycles
Time 31

32. Rate fading
Programming 32

33. Mode switching with 2:1 lock-in protection
The goal of mode switching:
Provides transition of atrial tachycardias to the ventricle
The goal of 2:1 Lock-In protection:
Ensures adequate mode switching even in difficult situations, e.g. long blanking and “slow“ tachycardias 33

34. Mode switching with 2:1 lock-in protection
When does 2:1 Lock-In occur?
A long blanking interval (>125ms) was programmed in the pacemaker
The patient suffers of atrial flutter 34

35. Mode switching with 2:1 lock-in protection
Ars Blanking As Vp
Ars Blanking As Vp
Example: Atrial flutter 240bpm, TARP 425 ms, PVAB 200 ms
The pacemaker ignores every second P wave, because it occures in the blanking. The sensed rate is 120bpm.
TARP
Blanking 35

36. Mode switching with 2:1 lock-in protection
Programming
and 36

37. Event below the intervention rate
Mode switching with 2:1 lock-in protection
Desynchronisation
Resynchronisation
...
DDD(R)
DDI(R)
DDI(R)
DDD(R)
...
...
1 out of 8
0 out of 8
...
0 out of 8
2 out of 8
0 out of 8
0 out of 8
1 out of 8
0 out of 8
...
out of 8
1 out of 8
...
3 out of 8
...
5 out of 8
4 out of 8
Example: X=5 (3-8)
Example: Z=5 (3-8)
Event above the intervention rate
Event below the intervention rate
During ERI mode switching is not disabled. 37

38. Mode switching with 2:1 lock-in protection
Termination of 2:1 lock-in by mode switching
Beginning of atrial flutter with 250 ppm. Philos II is in the 2:1 Lock-in . Beginning of the suspicion phases.
AV delay extention uncovers 2:1 Lock-in. Termination by immediate Mode Switching
Sinus-rhythm
2. P wave
1. P wave 38

39. VES lock-in protection
What is VES-lock-in?
It may occur that spontaneous P waves are sensed in the refractory period
As a consequence of this …
The following QRS-complex is classified as a VES
P waves will not be tracked
AV synchrony is lost
Mainly patients with first/second degree AV-block are affected
Who is affected? 39

40. VES lock-in protection
Description of VES-lock-in
Creates the picture of atrial undersensing despite the presence of ( intracardiac ) P waves larger then the programmed atrial sensitivity
May only occur during episodes of spontaneously conducted P waves with somewhat longer PR times
In literature also referred to as “Functional atrial undersensing” 40

41. VES lock-in protection
VES-lock-in timing As
Ars
Ars
Vs („VES“)
Vs („VES“)
Vs (VES) Vp
ARP
Basic Interval
ARP Extention 41

42. VES lock-in protection
The algorithm
Monitoring of Ars-VES sequences
Detection if programmed number (n= 4, 6 or 12) of Ars-VES cycles occur
Termination of the lock-in situation by an atrial pace, triggered by the atrial refractory sense (Ars)
VES lock-in protection restores AV synchrony 42

43. ... VES lock-in protection VES-lock-in termination ... „n“ cycles ARP
Ars
Ars Ap As
Vs („VES“) Vp Vp
...
... „n“ cycles
ARP
Basic interval
ARP extention 43

44. VES lock-in protection
Programming
Factory and standard setting = Off
Ves-lock-in protection = ON Programmable number of termination cycles: 4, 6, 12 44

45. VES lock-in protectionVs
(VES)
Ars
Ars Ap Vp As 45

46. VES lock-in protection
Statistics
VES-lock-in terminations counter in the „special events“ window 46

47. VES lock-in protection
Competitors
VES-lock-in protection is a unique function
Competitors do not provide a similar algorithm
BUT VES-lock-in behaviour has been reported at competitor pacemakers:
Pacesetter1,2
Vitatron1
Medtronic1
Biotronik1
1) Bode et al., PACE 1999
2) Barold, PACE 1999
Many of the terms sound similar but should not be confused. 47

48. Thank you for your kind attention!
Philos II offers you Convenience during implantation
Multiple effective therapy options
Conclusive diagnostics
Efficient follow-up 48

49. Thank you
for your attention!