warren klibbe marketing manager, berlin. philos ii functionality
TRANSCRIPT
Warren Klibbe
Marketing Manager, Berlin
Philos II
Functionality
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The Philos II Pacemaker Family
Philos II S has received a CE Mark too, but it will not be produced
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Philos II Functionality
Active Capture Control (ACC)
Wide Band IEGM Recordings
Auto-Initialisation
VES Lock-In Protection
Rate Fading
Home Monitoring
Mode Switching with 2:1 Lock-in-Protection
Follow-up
Negative AV Hysteresis
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Active Capture Control
ACC Function Overview
• Automatic, periodic measurement of ventricular pacing threshold
• Automatic reprogramming of pulse amplitude
• Provides beat-to-beat capture confirmation
• Back-up pulse upon detection of non-capture
• Signal check & threshold measurement - automatic and repeated
• Fusion discrimination algorithm
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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
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Active Capture Control
Evoked Response & Polarization Artefact
Evoked Response - The response of the myocardium to a pacing pulse of sufficient amplitude to cause cardiac depolarization. The evoked response is not related to the pacing threshold, R-wave amplitude, or slew rate.
Polarization Artifact - Noise that occurs between the pacing electrode and cardiac tissue after delivery of a pacing pulse. The polarization artifact is affected by the amplitude of the pacing pulse as well as the design of the surface of the lead.
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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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Active Capture Control
Pacing- Cause and Effect
Decreased polarization artifactImproved lead surface(low polarization lead)
No evoked responseNo polarization artifact
No pacing
Decreased polarization artifactDecreased pacing amplitude
Increased polarization artifactIncreased pacing amplitude
Evoked responseSome polarization artifact
Pacing with capture
No evoked responseSome polarization artifact
Pacing without capture
ResultEvent
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Active Capture Control
Non-Capture
A single ventricular pacing pulse that is classified as non-capture by ACC event classifier
Loss of Capture
A series of ventricular pacing pulses at varying AV delays that are classified as non-capture by ACC (with a maximum of 3 consecutive non-captures)
Non-Capture, Loss of Capture
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• Over the first 5 paces: analysis of the evoked response together with polarisation artefact.
• In the second step, 2 coupled paces (with a 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
The ventricular threshold is measured periodically and the stimulation amplitude is adapted
Automatic Threshold Measurement
• The measurement starts with the programmed „Maximum Amplitude“
• The output pace will step down at the beginning in larger and finally in smaller steps during the threshold measurement . Each decreased amplitude contains 2 paces
• A back-up pcace with higher energy is applied in case of no capture
• If, with a pacing amplitude of 0.1 Volt, the measurement indicates still capture, than the threshold-test is declaredas „ not succesful“.
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V1.6 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 Pulse 0.8 V @ 1.0 msExample
Active Capture Control
Automatic Threshold Measurement
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Active Capture Control
Amplitude Steps during Threshold Measurement
...
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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 no-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
Is the Backup Pulse effective?
The 2002 multicenter PACC study investigating the effectiveness of ACC showed that each backup pulse was successful.1)
Analyzed Holters 41
Detected ventricular events 4187726
Ventricular stimuli 3456318 (82.5%)
Ineffective stimuli 3189 (0.1%)
Backup pulses 3189 (0.1%)
Effective backup pulse 3189 (100%)1) Philos DR Active Capture Control (PACC) IDE #G010286 Clinical Report, Tab. 18, Dec. 2002.
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Active Capture Control
Fusion - Possible Effects
• Fusion can affect the morphology of the signal, which in some cases can cause ventricular pacing with fusion to be inappropriately classified as non-capture
• AV delay is modulated (lengthened / shortened) using a specific sequence to promote ventricular sensing or to promote ventricular pacing without fusion
• Fusion discrimination is only relevant during Capture Confirmation - AV delay during Signal Check/ Threshold Measurement is automatically set to a very short interval to ensure ventricular pacing and prevent fusion
• Fusion is not a safety issue but simply results in unnecessary back-up pacing
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Active Capture Control
Fusion Discrimination - Possible Effects
• Non-capture during Capture Confirmation could be the result of
– True non-capture
– Ventricular pacing with fusion
• Without fusion discrimination, Signal Check/ Threshold measurement would be initiated any time no capture was detected
• Fusion discrimination algorithm is invoked any time non-capture is detected at the normal AV delay
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Active Capture Control
Fusion Discrimination Algorithm
Step 1 - Lengthen the AV delay by 65 ms if non-capture is detected
– Promotes intrinsic ventricular activity– Avoids unnecessary ventricular pacing– AV delay remains lengthened as long as ventricular sensing occurs– Return to normal AV delay if ventricular pacing with capture occurs– Go to next step if non-capture is detected at long AV delay
Step 2 - Return to the normal AV delay
– Promotes ventricular pacing– Eliminates fusion that could have occurred at long AV delay– AV delay remains at the normal AV delay as long as ventricular sensing
occurs– Go to next step if non-capture is detected at the normal AV delay
Step 3 - Shorten AV delay to 15/50 ms following As/Ap events
– Return to Step 0 if capture is detected for 2 beats– Initiate Signal Check/Threshold Measurement if non-capture is still detected
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Active Capture Control
When does ACC algorithm start a new measurement?
• At change of relevant parameter: - mode- ventricular pulse amplitude and pulse width- ACC parameters- ventricular sense/pace polarity
• At the scheduled time/ interval
• At Loss-of-Capture detection(NOT at non-capture detection)
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Active Capture Control
Parameter Description
Maximum ACC Amplitude (MaxACCAmp)
The maximum amplitude setting that ACC can use and still distinguish capture from non-capture. In other words, this is the maximum amplitude where ACC will not misinterpret polarization artifact as capture (evoked response).
Minimum Amplitude
The smallest amplitude that the algorithm allows the output to be set to between automatic threshold searches.
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Active Capture Control
Parameter Description
Safety Margin
The difference between the measured pacing threshold and the programmed pacing amplitude. In other words, the safety margin is added to the measured pacing threshold.
Search Time
These parameter determines when the signal quality is checked and the pacing threshold is measured.
Two times of day or an interval of certain hours is alternatively programmable.
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Active Capture Control
Programmable Parameters
0.7 V 0.1 …(0.1)…actual AmplitudeMinimum Amplitude
0.5 V 0.3 … (0.1) … 1.2 VSafety Margin
02:00 & 14:0000:00 ... (15 minutes)... 23:45Time of Day
12 hours
Interval
3.6 V
ATM
Standard value
0.1, 0.3, 1, 3, 6, 12, 24 hour Interval
Off, ATM,OnACC activation
Interval, Time of Day Search Schedule
2.4, 3.6, 4.8, 6.4 V Maximum Amplitude
RangeParameter
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Active Capture Control
Programming
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Active Capture Control
Status Information
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Active Capture Control
ACC Algorithm Overview
Signal CheckThreshold Measurement
Capture Confirmation
ŸSets AV delay to 50msŸFive paces at MaxACCAmpŸFive "double paces" to
evaluate polarizationPass
Fail
ŸAV delay remains 50msŸStarting from MaxACCAmp,
stepwise reduction of theoutput every 2 cycles untilthreshold is found with a0.1V resolution
ŸBack-up pulse is emitted ifNo Capture occurs (pulsewidth set to 1ms)
ŸSet Amp = MaxACCAmp orhigher
ŸRepeat Signal Check/Thresholdmeasurement at next scheduled time
ŸThree consecutive doublefailures of Signal Check/Thresholdmeasurement will disable ACC
Set Amp = Threshold +Safety Margin
Fail
Pass
Beat-to-beat monitoring fornon-capture
Back-up pulse is emitted ifNo Capture occurs (pulsewidth set to 1ms)
If Loss of Capture is con-firmed, set Amp = MaxACCAmp and perform Signal Check/Threshold measurem.
Fusion avoidance scheme(AVD lengthening andshortening)
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Active Capture Control
Examples of Amplitude Settings
4.4 V(no Capture Confirmation)
2.0 V
1.0 V
1.5 V
0.7 V
Reprogrammed Amplitude
0.2 VSafety Margin = 0.5 VMaximum ACC Amplitude = 3.6 VMinimum ACC Amplitude = 0.7 V
3.2 VSafety Margin = 0.5 VMaximum ACC Amplitude = 3.6 VMinimum ACC Amplitude = 0.7 V
1.0 VSafety Margin = 1.0 VMaximum ACC Amplitude = 3.6 VMinimum ACC Amplitude = 0.7 V
0.2 VSafety Margin = 0.5 VMaximum ACC Amplitude = 3.6 VMinimum ACC Amplitude = 1.0 V
1.0 VSafety Margin = 0.5 VMaximum ACC Amplitude = 3.6 VMinimum ACC Amplitude = 0.7 V
Measured Threshold
Parameter Settings
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Active Capture Control
Behavior in special Situations (1)
Capture Confirmation will be disabled temporarly (back-up pulse as well) during following events:
– Mode Switching
– permanent noise
– rates above 110 ppm
• After the end of the event the pacemaker returns to Capture Confirmation.
• During the event the amplitude will be set to last measured threshold + 1.2 V (maximun safety margin)
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Active Capture Control
Behaviour in Special Situations (2)
Signal Check was not successful(possible reason: too high polarisation artefact or non-capture at MaxAccAmp)
• immediately after re-programming: ACC will be disabled pacing amplitude = MaxACCAmp
later: polarisation artefact too high -> MaxACCAmp
non-capture at MaxACCAmp -> MaxACCAmp + 1.2V „maximaler Amplitude“) gesetzt
later, 3 consecutive measurements ACC will be disabled pacing amplitude = MaxACCAmp + 1.2 V
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Active Capture Control
Behaviour in Special Situations (3)
Threshold measurement was not successful (possible reason: pacing with capture at 0.1 V)
• first measurement after reprogramming: ACC will be disabled pacing amplitude = MaxACCAmp
later: pacing amplitude = MaxACCAmp
ACC will be disabled temporarily
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Active Capture Control
Behaviour in Special Situations (4)
ERI has been reached:
ACC will be disabled The pacing amplitude will be set automatically to
last measured threshold + 1.2V
(1.2V =maximum safety margin)
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Active Capture Control
Available Statistics for ACC
Last measured threshold Status (if “disabled“: the reason- signal quality not sufficient - too much loss-of-capture- initial test not successful- ERI )
Threshold trend
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ACC Diagnostik
Available Statistics for ACC
Ventricular pacing amplitude trend
Histogram of ventrticular pacing amplitude
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All similar competitor algorithms perform a threshold measurement and adjustment of the pacing amplitude
Comparison aspects:• Back-up pace at no capture?
Main feature for patient safety
• Unipolar and bipolar pacing possible? compatible with defibrillators additional programming option at Phrenicus pacing / diaphragm pacing
• Fusion discrimination algorithm? Avoidance of unnecessary back-up pacing
Active Capture Control
Competitors
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unknown
yes
Yes
Medtronic
Kappa 900
(no Back-up-Puls)yesyesyes
Fusion discrimination algorithm
unknownnoyesyesUni- and bipolar configuration possible
noyesyesyesBack-up Pulse at non-capture
ELA
Talent 3
St. Jude Medical Identity
GuidantInsignia
Ultra
Biotronik
Philos II
Active Capture Control
Competitors
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Wide Band IEGM Recording
• Storage of up to 15 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
• Intelligent memory management
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Broadband IEGM Recording
• High atrial ratealternativelyMode Switching, Mode Conversion
• Magnet (Patient Activated)
• High ventricular rate
• PMT Termination
Trigger criteria
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Broadband IEGM Recording
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Broadband IEGM Recording
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• First 15 IEGM will be recorded.
• If the number of IEGM recordings is > 15t the following recordings will NOT be overwritten
the latest 3 patient activated IEGM recordings
4x high atrial rate , Mode Switching, respectively (oldest, longest, highest ventr. Rate, latest)
3x high ventricular rate(longest, highest ventr.rate, latest)
Broadband IEGM Recording
Intelligent Memory Management
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If the memory is filled with 15 IEGM recordings they will be overwritten by additional recordings with following priority:
•oldest recording of high ventr. rate
•oldest patient activated recording
•oldes recording of high atrial rate, Mode Switching/Mode Conversion
•oldest recording of PMT termination
Intelligent Memory Management
Broadband IEGM Recording
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Ela: 3x 3 seconds IEGMrecording in Talent III
Vitatron: no real time IEGM untill „C60-Family“ no automatic recording of IEGMs.
Relevant competitors :Insignia Ultra (Guidant), Identity (St.Jude Medical) Kappa 900 (Medtronic)
Broadband IEGM Recording
Competitors
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48 (after trigger) 32 (before Trigger)
48 (a+v)
120 (one channel)
110150Total recording time [seconds]
a + v summarised*
a or v or
summarised
a und v separately
a und v separately
Channels (a=atrial, v=ventricular)
8/0/6
4/4/4
2/16/0
a.a.
Medtronic
Kappa 900
12/2?/2?
4/6?/6?
1/24?/24?
a.a.
31/2/2
7/7/7
2/28/14
a.a.
15/7.5/2.5
Number of recordings /
Recording pre / post trigger [seconds]
St. Jude MedicalIdentity
Guidant
Insignia plus
Biotronik
Philos II
* Sourse: Guidant Insignia plus Salesfolder
Competitors
Broadband IEGM Recording
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Auto-Initialisation
• Continuous unipolar measurement of the lead impedance :Values between 200 and 3000 Ohm?
• Unip. Lead impedance = 200-3000 Ohm -> switch to bipolar mode
• Bip. Lead impedance = 200-3000 Ohm -> Philos II maintains bipolar mode
• Bip. Lead impedance 200-3000 Ohm -> Philos II switches back to unipolar mode
• Implant confirmation time : 30 min
Lead Detection
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• Confirmation time 30 minutes:Lead impedance within the range 200 – 3000 Ohm?
• Yes DDD(R,T): both channels Auto-Initialisation SLR,SR: vent. channel Auto-Initialisation
• No New start of automatic lead detection
• Inhibition of Philos II by sensing: triggert pacing each 3 minutes
Implant confirmation time
Auto-Initialisation
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Auto-Initialisation
• Start of the Statistics
• Activating of Mode Switching
• Activation of PMT-Protection
• Start of ventricular Threshold Monitoring (ATM)
• Storage of implantation date and lead polarity in the patient data
Function activation
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Auto-Initialisation
Diagnostic Memory
Mode SwitchingPMT Management
Function activation
Threshold Monitoring
Implant Confirmation Time 30 min
Lead DetectionPolarity Selection
Summary
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• Programmable: ON, OFF, Lead Detection (= polarity setting without function activation )
• Only active in Factory Mode
• Parameter disappears from Programmer screen after performing Auto-Initialisation
• Code „FACTORY” resets Philos II to factory values Auto-Initialisation can start again
Auto-Initialisation
Programming
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St. Jude Medical
Vitatron do not provide Auto-Initialisation Ela
Auto-Initialisation
Competitors
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Medtronic Kappa 900
• similar procedure (30 min. implant confirmation time, reprogramming to bipolar mode were applicable, asynchronous pacing every 5 min,)
• Function activation :– Auto-Sensing– Capture Management– Sensor– Search AV (AV-Hystereses)– Statistcs
Competitors
Auto-Initialisation
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Guidant Insignia plus
• Measurement of unipolar lead impedance, NO implant confirmation time
• NO switch to bipolar mode• Function activation:
– Mode Switching– PMT Termination – AV-Hystereis without Scan Hysteresis– Statistics
Auto-Initialisation
Competitors
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Turning on rate adaptive mode automatically is not desired by everyone.
Philos II vs. Medtronic Kappa 900 / Enpulse
Philos II vs. Guidant Insignia ultra
No programming of lead polarity no confirmation time, no activation of automatic threshold measurement (?)
Philos II vs. Rest
No Auto-Initialisation
Auto-Initialisation
Competitors (Summary)
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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
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
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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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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Medtronic : no similar algorithm
St Jude Medical : no similar algorithm
Vitatron : „Flywheel“ is similar to Rate Fading but is not programmable
Guidant : „Rate Smoothing“ similar to Rate Fading Rate increase 3% - 24% programmable Smoothing at increase can lead to AV dissotiation.
Ela: „Smoothing“similar to Rate Fading Rate decrease: „slow“; „fast“ Algorithm responds to slight rate variations too
Rate Fading
Competition
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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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and
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 will not be disabled.
Mode Switching with 2:1 Lock-in Protection
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Mode Switching with 2:1 Lock-in Protection
The Algorithm
• Suspicion phase Evaluation of VA intervals (rate > 100 ppm) Evaluation of the stability criterion
• Confirmation phase Modulation of the AV-Delay (max.300 ms) to “uncover” intrinsic events during atrial blanking (PVAB)
• Termination phase Termination of the 2:1 Lock-in-Situation by Mode Switching (without X/Z-out of 8 criterion)
Stepwise decrease of AV delay if no p wave was detected
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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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------------„Mode Conv.“
Mode Conv.
2nd algorithm
?Up to 300Up to350up to 200
Up to 200
Up to 200
Far field blanking PVAB (in ms)
------yes------yes2:1 Algorithm
low
very fast
beat-to-beat +
rate increase
Vitatron
C60DR
medium
fast
4-out-of-7
MedtronicKappa 900
very high very highhigh
(progr.)high
(progr.)Specifity
slowslowfast fastSpeed
rate increase
average. atrial rate
+1/-1 Counter
x/z-out of-8
Mode Switching Principle
ELA
Talent 3
St. Jude MedicalIdentity
GuidantInsignia
Plus
Biotronik
Philos II
Mode Switching with 2:1 Lock-in Protection
Competitors
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Negative AV Hystersis
AV Hysteresis „negative“:
• Suppression of intrinsic AV conduction
• Promoting of ventricular pacing
• Indicated f.e. at HOCM patients (hypertrophyc obstructive cardio-myopathy) without alternative therapy possibility
• The AV delay will be shortened only if necessary to promote ventricular pacing with optimum haemodynamics
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Negative AV Hysteresis
AV Delay
AV delay shortened by negative AV Hysteresis
1 ... 180 repetitive cycles with shortened AV delay
AS AS
VP VP
AS
VS VP
AS
VP
AS
VP
AS AS
VP
The Algorithm
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AV Hysteresis
Programming
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AV Hysteresis
ventricular pace preference
0...-110 msNegative
AV Hysteresis
1 ... 6 cycles
Repetitive AV Hysteresis
1
every 32 cycles
64 ms
Vitatron
C60DR
AV Delay modula-tion depending on no. of As/Ap in 16 intervalls
MedtronicKappa 900
5181 ... 6Number of search cycles
100 cycles
5 min32...1024
cyclesevery180
cyclesAV Scan Hysteresis Search Interval
DDD-AMC Mode
0...120 ms
0%... 100%
15%30%50%
Prolongation of the AV delay by the AV hysteresis
ELA
Talent 3
St. Jude MedicalIdentity
GuidantInsignia
Plus
Biotronik
Philos II
Competitors
81
SS
t03
05
Follow-up
Event List
82
SS
t03
05
Follow-up
Storage of follow-up data in the pacemaker
83
SS
t03
05
Follow-up
Storage of follow-up data in the pacemaker
84
SS
t03
05
Pre-SettingsAfter choosing a Philos II Pacemaker type in the Preferences screen an additional register ”Philos II“ is available:
Automatic storage of follow-up data
Sensing Test with programmer parameters (i.e. 40 ppm VDD / VVI)
Sensing Test with pacemaker settings (permanent program) i.e. 60 ppm DDD)
Follow-up
85
SS
t03
05
Follow-up
Automatic Threshold Test
86
SS
t03
05
Follow-up
Automatic Threshold Test
Signal CheckExample with Max ACC Amplitude = 3.6V
87
SS
t03
05
Follow-up
Automatic Threshold Test
• Double paces at each amplitude• Amplitude decrease first in bigger steps
88
SS
t03
05
Follow-up
Automatic Threshold Test
Below 1.0 V amplitude decrements in 0.1V
89
SS
t03
05
Follow-up
Automatic Threshold Test
• Threshold at 0.8V • No capture at 0.7V• Backup pace with capture at 0.7 V/ 1.0 ms
90
SS
t03
05
Follow-up
AT-Classification
91
SS
t03
05
Criterion for sudden onset: the average of the 4 previous atrial events is 25% higher than the average of 4 events prior to current average
Criterion of rate stability:
three of the five most recent atrial intervals do not differ from one another by more than 20%
Follow-up
AT-Classification
AS AS
VP VP
AS
VS VP
AS
VP
AS
VP
AS
VP
AS AS AS
VPVP
92
SS
t03
05
Follow-up
AT-Classification
93
SS
t03
05
Follow-up
High Resolution Impedance Trend
Impedance measurement is performed every90 min by a triggered pace at 4.8V
94
SS
t03
05
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
95
SS
t03
05
Home Monitoring
The Antenna
96
SS
t03
05
Home Monitoring
Transmitted Data (selection)
• Auto Lead Check (atrial and ventricular)
• Status Active Capture Control
• Ventricular Threshold
• Status ERI
• % AV Synchrony
• P-/ R-Wave Amplitude Trend
97
SS
t03
05
Thank you for your Attention!