Integrated Therapy
Warren KlibbeMarketing Manager CRM
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The Philos II pacemaker family
Philos II S has also the CE Mark, but will not be produced
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Philos II overview
Active capture control (ACC)
Broadband IEGM recordings
Auto-Initialization
Rate fading
Home Monitoring
Mode switching overdrive pacing
Follow-up
IRSplus
Eff
ect
ive &
effi
cien
t w
ork
flow
Implantation
Therapy
Follow-up
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Auto-initialisation
Diagnostic memory
Mode switchingPMT management
Function activation
Threshold monitoring
Implant confirmation time 30 min
Lead detectionpolarity selection
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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
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• Fusion discrimination reduces ventricular pacing
• Back-up pulse with increased width offersprotection from phrenic nerve stimulationassuring maximum energy efficacy
Intelligent details deliver superiority
• Single button activation
Easy and efficient use – active capture control
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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
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Pacing without capturePacing with capture
Evoked response
Signal check
Polarisation-artefact
Polarisation-artefact
Determinates whether evoked response and polarization artifact are acceptable
Active capture control
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• 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
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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“
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2.4 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 0.8 V @ 1.0 msExample
Active capture control
Automatic threshold measurement
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Active capture control
Amplitude steps during threshold measurement
...
17
0.9
16
1.0
15
1.1
...
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1.3
0.9
13
1.5
1.0
...
12
1.7
1.2
0.9
11
1.9
1.4
1.0
10
2.2
1.6
1.2
...
9
2.5
1.8
1.4
0.9
8
2.9
2.1
1.6
1.0
7
3.3
2.4
1.8
1.2
6
3.8
2.8
2.1
1.4
5
4.3
3.2
2.4
1.6
4
4.9
3.7
2.7
1.8
3
5.6
4.2
3.1
2.1
2
6.4
4.8
3.6
2.4
1
Amplitude Steps
(if capture is not lost during test)
3.6
2.4
6.4
4.8
Maximum
ACC
Amplitude
Note: below 1.0 V the step is always 0.1V
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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
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Active capture control
The back-up pulse
Ventricular paceactual amplitude with 0.4 ms non-capture
Back-up paceactual amplitude with 1.0 ms capture
Detection ofevoked response
60 msVentricular
blanking20 ms
Calculation, programming50 ms
131 ms
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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
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Active capture control
Available statistics for ACC
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Follow up: Automatic threshold test
• Fast and automatic determination of the ventricular threshold
• 100% security due to effective backup pacing assuring ventricular support
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FDA feasibility trial Philos II ACC
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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
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Broadband IEGM recording
No marker signal correlation
Reduced specificity of mode switching due to intermittent farfield sensing
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• 12 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
1
2
3
4
5
Automatic IEGM recordings
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Broadband IEGM recording
Appropriate mode switch due to AF
Optimal correlation: marker and event
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• Information about the origin and classification of AT
• Therapy verification
• Possibility to verify antitachycardia therapies
AT/AES classification
AV
AVIAARP AESW
Prematurity (e.g., 25%)
P-P interval
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Follow-up
Storage of follow-up data in the pacemaker
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Home Monitoring
Home Monitoring principle
3. Automatic data analysis in the service center
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
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Home Monitoring
The antenna
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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
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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
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Rate fading
Rate fading at sudden rate drop of intrinsic heart rate
10 bpm
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Intrinsic RateTarget RateBack-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
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Rate fading
Programming
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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
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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
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TARP Blanking
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 BlankingAs
Vp Vp
As As
Vp
Ars Blanking
Ars BlankingAs
Vp
As
Vp
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Mode switching with 2:1 lock-in protection
Programming
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DDD(R) DDD(R)DDI(R)
Desynchronisation Resynchronisation
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
0 out of 81 out of 8
out of 8... 5 out of 8
0 out of 8
0 out of 80 out of 8
1 out of 8...
Event above the intervention rateEvent 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
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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
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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?
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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
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VES lock-in protection
VES-lock-in timing
ARP Basic Interval
As
VpVs (VES) Vs („VES“) Vs („VES“)
Ars Ars
ARP Extention
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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
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VES lock-in protection
VES-lock-in termination
Vs („VES“)
Ars Ars Ap As
Vp
...
Vp
... „n“ cycles
ARP Basic interval ARP extention
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• Factory and standard setting = Off
• Ves-lock-in protection = ON
Programmable number of termination cycles: 4, 6, 12
Programming
VES lock-in protection
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Vs (VES)
ArsArs Ap
VpVp
As
Vp
As
Vs
Ars
Vs
Ars
Vs
Ars
VsVp
As
VES lock-in protection
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• VES-lock-in terminations counter in the „special events“ window
VES lock-in protection
Statistics
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• 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 19992) Barold, PACE 1999
VES lock-in protection
Competitors
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Thank you for your kind attention!
Philos II offers you Convenience during implantation
• Multiple effective therapy options
• Conclusive diagnostics
• Efficient follow-up
Thank you for your
attention!
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