Integrated Therapy Warren Klibbe Marketing Manager CRM.

Integrated Therapy

Warren KlibbeMarketing Manager CRM

2

Ph

ilos

II f

am

ily

The Philos II pacemaker family

Philos II S has also the CE Mark, but will not be produced

3

Ph

ilos

II f

am

ily

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

4

Ph

ilos

II f

am

ily

Auto-initialisation

Diagnostic memory

Mode switchingPMT management

Function activation

Threshold monitoring

Implant confirmation time 30 min

Lead detectionpolarity selection

5

Ph

ilos

II f

am

ily

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

Ph

ilos

II f

am

ily

• 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

7

Ph

ilos

II f

am

ily 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

Ph

ilos

II f

am

ily

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

9

Ph

ilos

II f

am

ily

• 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

Ph

ilos

II f

am

ily

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

Ph

ilos

II f

am

ily

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

12

Ph

ilos

II f

am

ily

Active capture control

Amplitude steps during threshold measurement

...

17

0.9

16

1.0

15

1.1

...

14

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

13

Ph

ilos

II f

am

ily

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

Ph

ilos

II f

am

ily

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

15

Ph

ilos

II f

am

ily

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

Ph

ilos

II f

am

ily

Active capture control

Available statistics for ACC

17

Ph

ilos

II f

am

ily

Follow up: Automatic threshold test

• Fast and automatic determination of the ventricular threshold

• 100% security due to effective backup pacing assuring ventricular support

19

Ph

ilos

II f

am

ily

FDA feasibility trial Philos II ACC

20

Ph

ilos

II f

am

ily

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

21

Ph

ilos

II f

am

ily

Broadband IEGM recording

No marker signal correlation

Reduced specificity of mode switching due to intermittent farfield sensing

22

Ph

ilos

II f

am

ily

• 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

23

Ph

ilos

II f

am

ily

Broadband IEGM recording

Appropriate mode switch due to AF

Optimal correlation: marker and event

24

Ph

ilos

II f

am

ily

• 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

25

Ph

ilos

II f

am

ily

Follow-up

Storage of follow-up data in the pacemaker

26

Ph

ilos

II f

am

ily

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

27

Ph

ilos

II f

am

ily

Home Monitoring

The antenna

28

Ph

ilos

II f

am

ily

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

Ph

ilos

II f

am

ily

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

Ph

ilos

II f

am

ily

Rate fading

Rate fading at sudden rate drop of intrinsic heart rate

10 bpm

31

Ph

ilos

II f

am

ily

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

32

Ph

ilos

II f

am

ily

Rate fading

Programming

33

Ph

ilos

II f

am

ily

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

Ph

ilos

II f

am

ily

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

Ph

ilos

II f

am

ily

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

36

Ph

ilos

II f

am

ily

and

Mode switching with 2:1 lock-in protection

Programming

37

Ph

ilos

II f

am

ily

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

38

Ph

ilos

II f

am

ily

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

Ph

ilos

II f

am

ily

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

Ph

ilos

II f

am

ily

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

Ph

ilos

II f

am

ily

VES lock-in protection

VES-lock-in timing

ARP Basic Interval

As

VpVs (VES) Vs („VES“) Vs („VES“)

Ars Ars

ARP Extention

42

Ph

ilos

II f

am

ily

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

Ph

ilos

II f

am

ily

VES lock-in protection

VES-lock-in termination

Vs („VES“)

Ars Ars Ap As

Vp

...

Vp

... „n“ cycles

ARP Basic interval ARP extention

44

Ph

ilos

II f

am

ily

• Factory and standard setting = Off

• Ves-lock-in protection = ON

Programmable number of termination cycles: 4, 6, 12

Programming

VES lock-in protection

45

Ph

ilos

II f

am

ily

Vs (VES)

ArsArs Ap

VpVp

As

Vp

As

Vs

Ars

Vs

Ars

Vs

Ars

VsVp

As

VES lock-in protection

46

Ph

ilos

II f

am

ily

• VES-lock-in terminations counter in the „special events“ window

VES lock-in protection

Statistics

47

Ph

ilos

II f

am

ily

• 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

48

Ph

ilos

II f

am

ily

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!