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Warren Klibbe Marketing Manager, Berlin. Philos II Functionality.

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

1 Warren Klibbe Marketing Manager, Berlin

2 Philos II Functionality

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

4 SSt 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

5 SSt 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

6 SSt 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

7 SSt 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.

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

9 SSt 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 polarization artifactDecreased pacing amplitude Increased polarization artifactIncreased pacing amplitude Evoked response Some polarization artifact Pacing with capture No evoked response Some polarization artifact Pacing without capture ResultEvent

10 SSt 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

11 SSt 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

12 SSt 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 declared as not succesful.

13 SSt 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 Pulse ms Example Active Capture Control Automatic Threshold Measurement

14 SSt Active Capture Control Amplitude Steps during Threshold Measurement Note: below 1.0 V the step is always 0.1V

15 SSt 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

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

17 SSt 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 Holters41 Detected ventricular events Ventricular stimuli (82.5%) Ineffective stimuli3189 (0.1%) Backup pulses3189 (0.1%) Effective backup pulse3189 ( 100% ) 1) Philos DR Active Capture Control (PACC) IDE #G Clinical Report, Tab. 18, Dec

18 SSt 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

19 SSt 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

20 SSt 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

21 SSt 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)

22 SSt 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.

23 SSt 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.

24 SSt Active Capture Control Programmable Parameters 0.7 V0.1 …(0.1)…actual AmplitudeMinimum Amplitude 0.5 V0.3 … (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 hourInterval Off, ATM,OnACC activation Interval, Time of DaySearch Schedule 2.4, 3.6, 4.8, 6.4 VMaximum Amplitude RangeParameter

25 SSt Active Capture Control Programming

26 SSt Active Capture Control Status Information

27 SSt Active Capture Control ACC Algorithm Overview Signal Check Threshold Measurement Capture Confirmation 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 Fail Pass Beat-to-beat monitoring for non-capture Back-up pulse is emitted if No Capture occurs (pulse width set to 1ms) If Loss of Capture is con- firmed, set Amp = MaxACC Amp and perform Signal Check/Threshold measurem. Fusion avoidance scheme (AVD lengthening and shortening)

28 SSt 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 = 0.5 V Maximum ACC Amplitude = 3.6 V Minimum ACC Amplitude = 0.7 V 1.0 V Safety Margin = 1.0 V Maximum ACC Amplitude = 3.6 V Minimum ACC Amplitude = 0.7 V 0.2 V Safety Margin = 0.5 V Maximum ACC Amplitude = 3.6 V Minimum ACC Amplitude = 1.0 V 1.0 V Safety Margin = 0.5 V Maximum ACC Amplitude = 3.6 V Minimum ACC Amplitude = 0.7 V Measured Threshold Parameter Settings

29 SSt 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)

30 SSt 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 V

31 SSt 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

32 SSt 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)

33 SSt 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

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

35 SSt 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

36 SSt unknown yes Yes Medtronic Kappa 900 (no Back- up-Puls) yes Fusion discrimination algorithm unknownnoyes Uni- and bipolar configuration possible noyes Back-up Pulse at non-capture ELA Talent 3 St. Jude Medical Identity Guidant Insignia Ultra Biotronik Philos II Active Capture Control Competitors

37 SSt Wide Band IEGM Recording Storage of up to 15 IEGM Recordings Recording of unfiltered atrial and ventricular IEGMs and marker channel Recording of 7,5 seconds before and 2,5 seconds after the trigger Intelligent memory management

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

39 SSt Broadband IEGM Recording

40 SSt Broadband IEGM Recording

41 SSt 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

42 SSt 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

43 SSt 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

44 SSt (after trigger) 32 (before Trigger) 48 (a+v) 120 (one channel) 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 /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 Medical Identity Guidant Insignia plus Biotronik Philos II * Sourse: Guidant Insignia plus Salesfolder Competitors Broadband IEGM Recording

45 SSt Auto-Initialisation 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 Lead Detection

46 SSt 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

47 SSt 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

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

49 SSt 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

50 SSt St. Jude Medical Vitatron do not provide Auto-Initialisation Ela Auto-Initialisation Competitors

51 SSt 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

52 SSt 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

53 SSt 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)

54 SSt 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

55 SSt 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?

56 SSt VES Lock-In Protection VES-Lock-in Timing ARPBasic Interval As Vp Vs (VES) Ars ARP Extention

57 SSt 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

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

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

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

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

62 SSt 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: Pacesetter 1,2 Vitatron 1 Medtronic 1 Biotronik 1 1) Bode et al., PACE ) Barold, PACE 1999 VES Lock-In Protection Competitors

63 SSt 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

64 SSt Rate Fading Back-up RateEffective pacing rate Target RateCalculated rate (mean detected rate) RF-Increasespeed of adaptation of the Back-up Rate towards a higher Target Rate RF-Decreasespeed of adaptation of the Back-up Rate towards a lower Target Rate Terminology

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

66 SSt Intrinsic Rate Target Rate Back-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

67 SSt Rate Fading Programming

68 SSt 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: Smoothingsimilar to Rate Fading Rate decrease: slow; fast Algorithm responds to slight rate variations too Rate Fading Competition

69 SSt 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

70 SSt 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

71 SSt TARPBlanking 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 Blanking As Vp As Vp Ars Blanking As Vp As Vp

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

73 SSt DDD(R) DDI(R) DesynchronisationResynchronisation 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 1 out of 8 out of out of 8 0 out of 8 1 out of 8... Event above the intervention rate Event 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

74 SSt 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

75 SSt 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

76 SSt Mode Conv. 2nd algorithm ?Up to 300Up to350 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 Medtronic Kappa 900 very high high (progr.) Specifity slow fast Speed rate increase average. atrial rate +1/-1 Counter x/z-out of-8 Mode Switching Principle ELA Talent 3 St. Jude Medical Identity Guidant Insignia Plus Biotronik Philos II Mode Switching with 2:1 Lock-in Protection Competitors

77 SSt 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

78 SSt Negative AV Hysteresis AV Delay AV delay shortened by negative AV Hysteresis repetitive cycles with shortened AV delay ASAS ASAS VPVP VPVP ASAS VSVS VPVP ASAS VPVP ASAS VPVP ASAS ASAS VPVP The Algorithm

79 SSt AV Hysteresis Programming

80 SSt AV Hysteresis 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 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 Competitors

81 SSt Follow-up Event List

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

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

84 SSt 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) Follow-up

85 SSt Follow-up Automatic Threshold Test

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

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

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

89 SSt 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 SSt Follow-up AT-Classification

91 SSt 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 ASAS ASAS VPVP VPVP ASAS VSVS VPVP ASAS VPVP ASAS VPVP ASAS VPVP ASAS ASAS ASAS VPVP VPVP

92 SSt Follow-up AT-Classification

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

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

95 SSt Home Monitoring The Antenna

96 SSt 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 SSt Thank you for your Attention!

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