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Warren Klibbe Marketing Manager, Berlin.

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Presentation on theme: "Warren Klibbe Marketing Manager, Berlin."— Presentation transcript:

1 Warren Klibbe Marketing Manager, Berlin

2 Philos II Functionality

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

4 Philos II Functionality
Active Capture Control (ACC) Wide Band IEGM Recordings Auto-Initialisation VES Lock-In Protection Rate Fading Mode Switching with 2:1 Lock-in-Protection Negative AV Hysteresis Follow-up Home Monitoring 4

5 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 5

6 Active Capture Control
3 Components of ACC Algorithm ACC at each periodically periodically pace Active Threshold Monitoring ATM Signal-analysis Threshold search Adjust-ment of the pacing amplitude Capture Control Successful Successful 6

7 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. 7

8 Active Capture Control
Signal Check Determinates whether evoked response and polarization artifact are acceptable Pacing with capture Pacing without capture Polarisation- artefact Polarisation- artefact Evoked response 8

9 Active Capture Control
Pacing- Cause and Effect Decreased polarization artifact Improved lead surface (low polarization lead) No evoked response No polarization artifact No pacing Decreased pacing amplitude Increased polarization artifact Increased pacing amplitude Evoked response Some polarization artifact Pacing with capture Pacing without capture Result Event 9

10 Active Capture Control
Non-Capture, Loss of Capture 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) 10

11 Active Capture Control
Signal analysis 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 11

12 Active Capture Control
Automatic Threshold Measurement The ventricular threshold is measured periodically and the stimulation amplitude is adapted 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 declared as „ not succesful“. 12

13 Active Capture Control
Automatic Threshold Measurement Back-up Pulse ms Example Maximum ACC Amplitude = 2.4 V Safety Margin = 0.5 V Threshold = 0.9 V 2.4 V 2.1 V 1.8 V 1.6 V 1.4 V 1.2 V 1.0 V 0.9 V 0.8 V 1.4 V 13

14 Active Capture Control
Amplitude Steps during Threshold Measurement ... 17 0.9 16 1.0 15 1.1 14 1.3 13 1.5 12 1.7 1.2 11 1.9 1.4 10 2.2 1.6 9 2.5 1.8 8 2.9 2.1 7 3.3 2.4 6 3.8 2.8 5 4.3 3.2 4 4.9 3.7 2.7 3 5.6 4.2 3.1 2 6.4 4.8 3.6 1 Amplitude Steps (if capture is not lost during test) Maximum ACC Amplitude Note: below 1.0 V the step is always 0.1V 14

15 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 15

16 Active Capture Control
The Back-up Pulse Detection of evoked response 60 ms Ventricular Blanking 20 ms Calculation, Programming 50 ms 131 ms Ventricular pace actual amplitude with 0.4 ms non-capture Back-up pace actual amplitude with 1.0 ms capture 16

17 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 Ventricular stimuli (82.5%) Ineffective stimuli (0.1%) Backup pulses (0.1%) Effective backup pulse (100%) 1) Philos DR Active Capture Control (PACC) IDE #G Clinical Report, Tab. 18, Dec 17

18 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 18

19 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 19

20 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 20

21 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) 21

22 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. 22

23 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. 23

24 Active Capture Control
Programmable Parameters 0.7 V 0.1 …(0.1)…actual Amplitude Minimum Amplitude 0.5 V 0.3 … (0.1) … 1.2 V Safety Margin 02:00 & 14:00 00: (15 minutes)... 23:45 Time of Day 12 hours Interval 3.6 V ATM Standard value 0.1, 0.3, 1, 3, 6, 12, 24 hour Off, ATM,On ACC activation Interval, Time of Day Search Schedule 2.4, 3.6, 4.8, 6.4 V Maximum Amplitude Range Parameter 24

25 Active Capture Control
Programming 25

26 Active Capture Control
Status Information 26

27 Active Capture Control
ACC Algorithm Overview Signal Check Threshold Measurement Capture Confirmation Ÿ Sets AV delay to 50ms Five paces at MaxACCAmp Five "double paces" to evaluate polarization Pass Fail AV delay remains 50ms Starting from MaxACCAmp, stepwise reduction of the output every 2 cycles until threshold is found with a 0.1V resolution Back-up pulse is emitted if No Capture occurs (pulse width set to 1ms) Set Amp = MaxACCAmp or higher Repeat Signal Check/Threshold measurement at next scheduled time Three consecutive double failures of Signal Check/Threshold measurement will disable ACC Set Amp = Threshold + Safety Margin Beat-to-beat monitoring for non-capture If Loss of Capture is con- firmed, set Amp = MaxACC Amp and perform Signal Check/Threshold measurem. Fusion avoidance scheme (AVD lengthening and shortening) 27

28 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 V Safety Margin = 0.5 V Maximum ACC Amplitude = 3.6 V Minimum ACC Amplitude = 0.7 V 3.2 V Safety Margin = 1.0 V Minimum ACC Amplitude = 1.0 V Measured Threshold Parameter Settings 28

29 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 V (maximun safety margin) 29

30 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 pacing amplitude = MaxACCAmp V 30

31 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: ACC will be disabled temporarily 31

32 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) 32

33 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 33

34 ACC Diagnostik Available Statistics for ACC
Histogram of ventrticular pacing amplitude Ventricular pacing amplitude trend 34

35 Active Capture Control
Competitors 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 Many of the terms sound similar but should not be confused. 35

36 Active Capture Control
Competitors unknown yes Yes Medtronic Kappa 900 (no Back-up-Puls) Fusion discrimination algorithm no Uni- and bipolar configuration possible Back-up Pulse at non-capture ELA Talent 3 St. Jude Medical Identity Guidant Insignia Ultra Biotronik Philos II Many of the terms sound similar but should not be confused. 36

37 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 37

38 Broadband IEGM Recording
Trigger criteria High atrial rate alternatively Mode Switching, Mode Conversion Magnet (Patient Activated) High ventricular rate PMT Termination 38

39 Broadband IEGM Recording

40 Broadband IEGM Recording

41 Broadband IEGM Recording
Intelligent Memory Management 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) 41

42 Broadband IEGM Recording
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 42

43 Broadband IEGM Recording
Competitors 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) Many of the terms sound similar but should not be confused. 43

44 Broadband IEGM Recording
Competitors 48 (after trigger) 32 (before Trigger) 48 (a+v) 120 (one channel) 110 150 Total recording time [seconds] a + v summarised* a or v or summarised 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? 31/2/2 7/7/7 2/28/14 15/7.5/2.5 Number of recordings / Recording pre / post trigger [seconds] St. Jude Medical Identity Guidant Insignia plus Biotronik Philos II Many of the terms sound similar but should not be confused. * Sourse: Guidant Insignia plus Salesfolder 44

45 Auto-Initialisation Lead Detection
Continuous unipolar measurement of the lead impedance : Values between 200 and 3000 Ohm? Unip. Lead impedance = Ohm -> switch to bipolar mode Bip. Lead impedance = Ohm -> Philos II maintains bipolar mode Bip. Lead impedance  Ohm -> Philos II switches back to unipolar mode Implant confirmation time : 30 min 45

46 Auto-Initialisation Implant confirmation time
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 46

47 Auto-Initialisation Function activation 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 47

48 Implant Confirmation Time
Auto-Initialisation Summary Implant Confirmation Time 30 min Lead Detection Polarity Selection Diagnostic Memory Mode Switching PMT Management Function activation Threshold Monitoring 48

49 Auto-Initialisation Programming
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 49

50 Auto-Initialisation Competitors St. Jude Medical
Vitatron do not provide Auto-Initialisation Ela Many of the terms sound similar but should not be confused. 50

51 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 Many of the terms sound similar but should not be confused. 51

52 Auto-Initialisation Competitors 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 Many of the terms sound similar but should not be confused. 52

53 Auto-Initialisation Competitors (Summary)
Philos II vs. Medtronic Kappa 900 / Enpulse Turning on rate adaptive mode automatically is not desired by everyone. 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 53 * ... Quelle: ...

54 VES Lock-In Protection
Description of VES-Lock-in 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” 54

55 VES Lock-In Protection
What is 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 Who is affected? 55

56 VES Lock-In Protection
VES-Lock-in Timing As Ars Ars Vs („VES“) Vs („VES“) Vs (VES) Vp ARP Basic Interval ARP Extention 56

57 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 57

58 ... VES Lock-In Protection VES-Lock-in Termination ... „n“ cycles ARP
Ars Ars Ap As Vs („VES“) Vp Vp ... ... „n“ cycles ARP Basic Interval ARP Extention 58

59 VES Lock-In Protection
Programming Factory and Standard setting = Off Ves-Lock-in Protection = ON Programmable number of termination cycles: 4, 6, 12 59

60 VES Lock-In Protection
Vs (VES) Ars Ars Ap Vp As 60

61 VES Lock-In Protection
Statistics VES-Lock-in terminations counter in the „Special Events“ Window 61

62 VES Lock-In Protection
Competitors 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 1999 2) Barold, PACE 1999 Many of the terms sound similar but should not be confused. 62

63 Rate Fading (Rate smoothing)
Purpose of Rate Fading 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 63

64 Rate Fading Terminology 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 64

65 Rate Fading Rate Fading at sudden rate drop of intrinsic heart rate
10 bpm 65

66 Rate Fading Intrinsic Rate Target Rate Back-up Rate Basic Rate
Increasing the Back-up Rate for 2 bpm / cycle (example) Reduction of the Back-up Rate for 0,5 bpm/cycle (example) 10 ppm Basic Rate 4 Cycles Time 66

67 Rate Fading Programming 67

68 Rate Fading Competition 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 Many of the terms sound similar but should not be confused. 68

69 Mode Switching with 2:1 Lock-in Protection
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 69

70 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 70

71 Mode Switching with 2:1 Lock-in Protection
Ars Blanking As Vp Ars Blanking As Vp 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. TARP Blanking 71

72 Mode Switching with 2:1 Lock-in Protection
Programming and 72

73 Event below the intervention rate
Mode Switching with 2:1 Lock-in Protection Desynchronisation Resynchronisation ... DDD(R) DDI(R) DDI(R) DDD(R) ... ... 1 out of 8 0 out of 8 ... 0 out of 8 2 out of 8 0 out of 8 0 out of 8 1 out of 8 0 out of 8 ... out of 8 1 out of 8 ... 3 out of 8 ... 5 out of 8 4 out of 8 Example: X=5 (3-8) Example: Z=5 (3-8) Event above the intervention rate Event below the intervention rate During ERI Mode Switching will not be disabled. 73

74 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 74

75 Mode Switching with 2:1 Lock-in Protection
Termination of 2:1 Lock-in by Mode Switching 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 Sinus-rhythm 2. P wave 1. P wave 75

76 beat-to-beat + rate increase
Mode Switching with 2:1 Lock-in Protection Competitors Biotronik Philos II Guidant Insignia Plus St. Jude Medical Identity Medtronic Kappa 900 Vitatron C60DR ELA Talent 3 Mode Switching Principle x/z-out of-8 +1/-1 Counter average. atrial rate 4-out-of-7 beat-to-beat + rate increase rate increase Speed fast fast slow fast very fast slow Specifity high (progr.) high (progr.) very high medium low very high Many of the terms sound similar but should not be confused. 2:1 Algorithm yes --- --- yes --- --- Far field blanking PVAB (in ms) Up to 200 Up to 200 up to 200 Up to350 Up to 300 ? 2nd algorithm Mode Conv. „Mode Conv.“ --- --- --- --- 76

77 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 77

78 Negative AV Hysteresis
The Algorithm AV Delay AV delay shortened by negative AV Hysteresis repetitive cycles with shortened AV delay AS VP VS 78

79 AV Hysteresis Programming * ... Quelle: ... 79

80 AV Hysteresis Competitors   0...-110 ms 1 ... 6 cycles 1
ventricular pace preference ms Negative AV Hysteresis 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 Medtronic Kappa 900 5 8 Number of search cycles 100 cycles 5 min cycles every180 cycles AV Scan Hysteresis Search Interval DDD-AMC Mode ms 0% % 15% 30% 50% Prolongation of the AV delay by the AV hysteresis ELA Talent 3 St. Jude Medical Identity Guidant Insignia Plus Biotronik Philos II Many of the terms sound similar but should not be confused. 80

81 Follow-up Event List 81

82 Follow-up Storage of follow-up data in the pacemaker 82

83 Follow-up Storage of follow-up data in the pacemaker 83

84 Follow-up Pre-Settings After 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) 84

85 Follow-up Automatic Threshold Test 85

86 Follow-up Automatic Threshold Test Signal Check
Example with Max ACC Amplitude = 3.6V 86

87 Follow-up Automatic Threshold Test Double paces at each amplitude
Amplitude decrease first in bigger steps 87

88 Follow-up Automatic Threshold Test
Below 1.0 V amplitude decrements in 0.1V 88

89 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 89

90 Follow-up AT-Classification 90

91 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% AS AS AS AS AS AS AS AS AS VP VP VS VP VP VP VP VP VP 91

92 Follow-up AT-Classification 92

93 Follow-up High Resolution Impedance Trend
Impedance measurement is performed every 90 min by a triggered pace at 4.8V 93

94 Home Monitoring Home Monitoring principle
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 3. Automatic Data analysis in the Service Center 94

95 Home Monitoring The Antenna 95

96 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 96

97 Thank you for your Attention!

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