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

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

4 Philos II family 4 Auto-initialisation Diagnostic memory Mode switchingPMT management Function activation Threshold monitoring Implant confirmation time 30 min Lead detection polarity selection

5 Philos II family 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

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

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

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

9 Philos II family 9 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 Active capture control Signal analysis

10 Philos II family 10 Active capture control (ACC) The ventricular threshold is measured periodically and the stimulation amplitude is adapted Automatic threshold measurement 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

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

12 Philos II family 12 Active capture control Amplitude steps during threshold measurement Note: below 1.0 V the step is always 0.1V

13 Philos II family 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

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

15 Philos II family 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

16 Philos II family 16 Active capture control Available statistics for ACC

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

18 Philos II family 18 Active capture control Programming

19 Philos II family 19 FDA feasibility trial Philos II ACC

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

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

22 Philos II family event memories (of approx 10 seconds each) Intelligent memory management, NOT First-In First-Out Intelligent memory management Clinically relevant events are not overwritten 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 Automatic IEGM recordings

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

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

25 Philos II family 25 Follow-up Storage of follow-up data in the pacemaker

26 Philos II family 26 Home Monitoring Home Monitoring principle 3. Automatic data analysis in the service center

27 Philos II family 27 Home Monitoring The antenna

28 Philos II family 28 Rate Fading (Rate smoothing) 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 Purpose of rate fading

29 Philos II family 29 Rate fading 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 Terminology

30 Philos II family 30 Rate fading Rate fading at sudden rate drop of intrinsic heart rate 10 bpm

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

32 Philos II family 32 Rate fading Programming

33 Philos II family 33 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 Mode switching with 2:1 lock-in protection

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

35 Philos II family 35 TARPBlanking 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. Mode switching with 2:1 lock-in protection Ars Blanking As Vp As Vp Ars Blanking As Vp As Vp

36 Philos II family 36 and Mode switching with 2:1 lock-in protection Programming

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

38 Philos II family 38 Mode switching with 2:1 lock-in protection Termination of 2:1 lock-in by mode switching Sinus- rhythm 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 2. P wave 1. P wave

39 Philos II family 39 VES lock-in protection 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 What is VES-lock-in? Who is affected?

40 Philos II family 40 VES lock-in protection 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 Description of VES-lock-in

41 Philos II family 41 VES lock-in protection VES-lock-in timing ARPBasic Interval As Vp Vs (VES) Ars ARP Extention

42 Philos II family 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

43 Philos II family 43 VES lock-in protection VES-lock-in termination Vs (VES) Ars Ars Ap As Vp... Vp... n cycles ARPBasic interval ARP extention

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

45 Philos II family 45 Vs (VES) Ars Ars Ap Vp As Vp As Vs Ars Vs Ars Vs Ars Vs Vp As VES lock-in protection

46 Philos II family 46 VES-lock-in terminations counter in the special events window VES lock-in protection Statistics

47 Philos II family 47 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: Pacesetter 1,2 Vitatron 1 Medtronic 1 Biotronik 1 1) Bode et al., PACE ) Barold, PACE 1999 VES lock-in protection Competitors

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

49 Thank you for your attention!

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