Warren Klibbe Marketing Manager, Berlin. Philos II Functionality.

Warren Klibbe

Marketing Manager, Berlin

Philos II

Functionality

The Philos II Pacemaker Family

Philos II S has received a CE Mark too, but it will not be produced

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

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

3 Components of ACC Algorithm

Successful

Adjust-ment of

the pacing

amplitude

Capture Control

Active Threshold Monitoring

Signal-

analysis

Successful

at each periodically periodically pace

Threshold search

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.

Pacing without capturePacing with capture

Evoked response

Signal Check

Polarisation-artefact

Determinates whether evoked response and polarization artifact are acceptable

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

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

• 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

Signal analysis

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“.

05 2.4

V1.6 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

Automatic Threshold Measurement

Amplitude Steps during Threshold Measurement

Amplitude Steps

(if capture is not lost during test)

Maximum

Amplitude

Note: below 1.0 V the step is always 0.1V

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

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

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.

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

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

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

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)

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.

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.

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

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

Programming

Status Information

ACC Algorithm Overview

Signal CheckThreshold Measurement

Capture Confirmation

ŸSets AV delay to 50msŸFive paces at MaxACCAmpŸFive "double paces" to

evaluate polarizationPass

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

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)

Examples of Amplitude Settings

4.4 V(no Capture Confirmation)

Reprogrammed Amplitude

0.2 VSafety Margin = 0.5 VMaximum ACC Amplitude = 3.6 VMinimum ACC Amplitude = 0.7 V

Measured Threshold

Parameter Settings

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)

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

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

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)

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

ACC Diagnostik

Available Statistics for ACC

Ventricular pacing amplitude trend

Histogram of ventrticular pacing amplitude

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

Competitors

unknown

Medtronic

Kappa 900

(no Back-up-Puls)yesyesyes

Fusion discrimination algorithm

unknownnoyesyesUni- and bipolar configuration possible

noyesyesyesBack-up Pulse at non-capture

Talent 3

St. Jude Medical Identity

GuidantInsignia

Biotronik

Philos II

Competitors

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

Broadband IEGM Recording

• High atrial ratealternativelyMode Switching, Mode Conversion

• Magnet (Patient Activated)

• High ventricular rate

• PMT Termination

Trigger criteria

• 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)

Intelligent Memory Management

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

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)

Competitors

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

Channels (a=atrial, v=ventricular)

2/16/0

Medtronic

Kappa 900

12/2?/2?

4/6?/6?

1/24?/24?

31/2/2

2/28/14

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

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

• 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

• 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

Auto-Initialisation

Diagnostic Memory

Mode SwitchingPMT Management

Function activation

Threshold Monitoring

Implant Confirmation Time 30 min

Lead DetectionPolarity Selection

Summary

• 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

St. Jude Medical

Vitatron do not provide Auto-Initialisation Ela

Auto-Initialisation

Competitors

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

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

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)

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

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?

VES-Lock-in Timing

ARP Basic Interval

VpVs (VES) Vs („VES“) Vs („VES“)

Ars Ars

ARP Extention

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

VES-Lock-in Termination

Vs („VES“)

Ars Ars Ap As

... „n“ cycles

ARP Basic Interval ARP Extention

• Factory and Standard setting = Off

• Ves-Lock-in Protection = ON

Programmable number of termination cycles: 4, 6, 12

Programming

Vs (VES)

ArsArs Ap

• VES-Lock-in terminations counter in the „Special Events“ Window

Statistics

• 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

Competitors

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

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

Rate Fading

Rate Fading at sudden rate drop of intrinsic heart rate

10 bpm

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

Programming

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

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

When does 2:1 Lock-In occur?

• A long blanking interval (>125ms) was programmed in the pacemaker

• The patient suffers of atrial flutter

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.

Ars BlankingAs

Ars Blanking

Ars BlankingAs

Programming

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.

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

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

------------„Mode Conv.“

Mode Conv.

2nd algorithm

?Up to 300Up to350up to 200

Up to 200

Far field blanking PVAB (in ms)

------yes------yes2:1 Algorithm

very fast

beat-to-beat +

rate increase

Vitatron

medium

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

Talent 3

GuidantInsignia

Biotronik

Philos II

Competitors

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

Negative AV Hysteresis

AV Delay

AV delay shortened by negative AV Hysteresis

1 ... 180 repetitive cycles with shortened AV delay

The Algorithm

AV Hysteresis

Programming

AV Hysteresis

ventricular pace preference

0...-110 msNegative

AV Hysteresis

1 ... 6 cycles

Repetitive AV Hysteresis

every 32 cycles

Vitatron

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

Talent 3

GuidantInsignia

Biotronik

Philos II

Competitors

Follow-up

Event List

Follow-up

Storage of follow-up data in the pacemaker

Follow-up

Storage of follow-up data in the pacemaker

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

Automatic Threshold Test

Follow-up

Signal CheckExample with Max ACC Amplitude = 3.6V

Follow-up

• Double paces at each amplitude• Amplitude decrease first in bigger steps

Follow-up

Below 1.0 V amplitude decrements in 0.1V

Follow-up

• Threshold at 0.8V • No capture at 0.7V• Backup pace with capture at 0.7 V/ 1.0 ms

Follow-up

AT-Classification

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 AS

Follow-up

AT-Classification

Follow-up

High Resolution Impedance Trend

Impedance measurement is performed every90 min by a triggered pace at 4.8V

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

Home Monitoring

The Antenna

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

Thank you for your Attention!

Warren Klibbe Marketing Manager, Berlin. Philos II Functionality.

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