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Integrated Therapy Warren Klibbe Marketing Manager CRM.

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Presentation on theme: "Integrated Therapy Warren Klibbe Marketing Manager CRM."— Presentation transcript:

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 ACC

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 protection
Vs (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!

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