BIOTRONIK Evia HF Technical Manual
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BIOTRONIK Evia HF Technical Manual

Implantable pulse generators
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Evia HF / HF-T
Technical Manual
Cardiac Rhythm Management
Heart Failure Therapy
Evia HF / HF-T

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Summary of Contents for BIOTRONIK Evia HF

  • Page 1 Cardiac Rhythm Management Heart Failure Therapy Evia HF / HF-T Evia HF / HF-T Technical Manual...
  • Page 2 CAUTION Federal (U.S.A.) law restricts this device to sale by or on the order of, a physician (or properly licensed practitioner). © 2016 BIOTRONIK, Inc., all rights reserved.

  • Page 3: Table Of Contents

    Table of Contents Evia HF / HF-T Technical Manual Contents 1. Device Description .......................1 2. Indications ..........................3 3. Contraindications .........................5 4. Warnings and Precautions ....................7 4.1 Medical Therapy .......................7 4.2 Storage and Sterilization ....................8 4.3 Lead Connection and Evaluation ..................8 4.4 Programming and Operation ....................9...
  • Page 4 Chapter Table of Contents Evia HF / HF-T Technical Manual 5.5.4.1 Dynamic AV Delay ....................31 5.5.4.2 AV Hysteresis ......................32 5.5.4.3 AV Repetitive Hysteresis ..................33 5.5.4.4 AV Scan Hysteresis ....................34 5.5.4.5 Negative AV Delay Hysteresis ................34 5.5.4.6 I-Opt ........................35 5.5.4.7 EasyAV ........................35 5.5.5 Ventricular Blanking After Ap ..................36...
  • Page 5 Chapter Table of Contents Evia HF / HF-T Technical Manual 5.18 Home Monitoring (Evia HF-T) ..................60 5.18.1 Transmission of Information ..................61 5.18.2 Patient Device ......................61 5.18.3 Transmitting Data .....................61 5.18.4 Types of Report Transmissions ................62 5.18.4.1 Trend Report ......................62 5.18.4.2 Event Report ......................62 5.18.5 Description of Transmitted Data ................63...
  • Page 6 Chapter Table of Contents Evia HF / HF-T Technical Manual 6.7.3 Heart Rate Variability ....................84 6.7.4 Patient Activity ......................84 6.7.5 Thoracic Impedance ....................84 6.8 IEGM Recordings ......................85 7. Other Functions/Features ....................87 7.1 Safe Program Settings ....................87 7.2 Magnet Effect .........................87 7.2.1 Automatic Magnet Effect ....................87...
  • Page 7 Chapter Table of Contents Evia HF / HF-T Technical Manual 10.6.1 Description ......................105 10.6.2 Burst Stimulation ....................106 10.6.3 Programmed Stimulation ..................106 10.6.4 Back up Pacing ......................107 10.6.5 NIPS Safety Features.....................107 10.7 Optimizing Rate Adaptation ..................108 10.7.1 Rate/Sensor Trend ....................108 10.7.2 Adjusting the Sensor Gain ..................108 10.7.3 Adjusting the Sensor Threshold ................109...
  • Page 8 Chapter Table of Contents Evia HF / HF-T Technical Manual PAGE vi...

  • Page 9: Device Description

    Evia HF / HF-T is a multi-programmable, three chamber pulse generator with rate-adaptive pacing. The Evia HF / HF-T pulse generator is BIOTRONIK’s state of the art pacing system with two methods of rate-adaptation. Rate-adaptation is achieved through programming of either the unique principle of closed-loop stimulation (CLS) or by motion-based pacing via a capacitive accelerometer.
  • Page 10 Evia HF / HF-T is designed to meet all indications for bradycardia and resynchronization therapy as exhibited in a wide variety of patients. The Evia HF / HF-T family is comprised of two CRT-Ps that are designed to handle a multitude of situations.

  • Page 11: Indications

    Evia HF / HF-T Technical Manual 2. Indications The Evia HF and Evia HF-T Cardiac Resynchronization Therapy Pacemakers (CRT-Ps) are indicated for patients who have moderate to severe heart failure (NYHA Class III/IV), including left ventricular dysfunction (EF ≤ 35%) and QRS ≥ 120 ms and remain symptomatic despite stable, optimal heart failure drug therapy.
  • Page 12 Chapter 2 Indications Evia HF / HF-T Technical Manual PAGE 4...

  • Page 13: Contraindications

    Evia HF / HF-T Technical Manual 3. Contraindications Use of Evia HF / HF-T pulse generator is contraindicated for the following patients: • Unipolar pacing is contraindicated for patients with an implanted cardioverter-defibrillator (ICD) because it may cause unwanted delivery or inhibition of ICD therapy.
  • Page 14 Chapter 3 Contraindications Evia HF / HF-T Technical Manual PAGE 6...

  • Page 15: Warnings And Precautions

    Chapter 4 Warnings and Precautions Evia HF / HF-T Technical Manual 4. Warnings and Precautions Certain therapeutic and diagnostic procedures may cause undetected damage to a pulse generator, resulting in malfunction or failure at a later time. Please note the following warnings and precautions:...

  • Page 16: Storage And Sterilization

    It is required to use a low polarization ventricular lead for activation of Ventricular Capture Control. Lead Check The Evia HF / HF-T pulse generators have an automatic lead check feature which may switch from bipolar to unipolar pacing and sensing without warning. This situation may be inappropriate for patients with an Implantable Cardioverter Defibrillator (ICD).

  • Page 17: Programming And Operation

    Leave the torque wrench in the slot of the setscrew(s) while the lead is inserted. Tightening Setscrew(s) Do not overtighten the setscrew(s). Use only the BIOTRONIK supplied torque wrench. Sealing System Be sure to properly insert the torque wrench into the perforation at an angle perpendicular to the connector receptacle.

  • Page 18: Home Monitoring

    4.5 Home Monitoring BIOTRONIK’s Home Monitoring system is designed to notify clinicians in less than 24 hours of changes to the patient’s condition or status of the implanted device. Updated data may not be available if: •...

  • Page 19: Electromagnetic Interference (Emi)

    BIOTRONIK pulse generators have been designed to significantly reduce susceptibility to electromagnetic interference (EMI). However, due to the variety and complexity of sources creating interference, there is no absolute protection against EMI.

  • Page 20: Cellular Phones

    4.7 Pulse Generator Explant and Disposal Device Incineration Never incinerate a pulse generator. Be sure the pulse generator is explanted before a patient who has died is cremated (see Section 12). Explanted Devices Return all explanted devices to BIOTRONIK. PAGE 12...

  • Page 21: Programmable Parameters

    For a complete list of programmable parameters and the available settings, see Section 13. 5.1 Pacing Modes A complete list of pacing modes available in Evia HF / HF-T is shown below. Figure 1: Pacing Modes in Evia HF / HF-T...

  • Page 22: Non-Rate-Adaptive Modes

    5.1.3 Non-Rate-Adaptive Modes Non-rate-adaptive modes that are programmable with the Evia CRT-P perform similarly to earlier generations of BIOTRONIK pulse generators (i.e., Philos II DR and Dromos DR). 5.1.4 Mode Switching Evia CRT-P provides Mode Switching to change pacing modes as a result of atrial tachycardias.
  • Page 23 VDIR Table 2: Mode Switch Mode Operations Ventricular Pacing (Evia HF / HF-T only) RV only or BiV pacing uses the same pacing programming values as seen under the Ventricular pacing parameter button. With Biventricular pacing programmed ON, pacing during Mode Switch will be Biventricular as well.

  • Page 24: Pacing Modes With Triggered Response

    10 bpm. 2:1 Lock-In Protection (available in the Evia HF/HF-T only if RV only pacing is programmed) For patients who experience atrial flutter, there is a small chance that Mode Switch will not occur due to atrial events falling within far-field protection.

  • Page 25: Rate Related Functions

    2) sets the lower pacing rate for the pacemaker and may be programmed from 30 bpm to 200 bpm. Evia HF / HF-T will allow pacing lower than the programmed rate when the parameter Hysteresis is enabled. The Hysteresis parameter is found under Basic rate / Night rate.

  • Page 26: Rate Hysteresis

    Chapter 5 Programmable Parameters Evia HF / HF-T Technical Manual CAUTION Programming Modification Extreme programming changes should only be made after careful clinical assessment. Clinical judgment should be used when programming permanent pacing rates below 40 ppm or above 100 ppm.

  • Page 27: Scan Hysteresis

    Chapter 5 Programmable Parameters Evia HF / HF-T Technical Manual If Hysteresis is used in the DDI mode, the AV delay must be programmed shorter than the spontaneous AV conduction time. Otherwise, stimulation in the absence of spontaneous activity occurs at the hysteresis rate instead of the lower rate.

  • Page 28: Night Mode

    Night rate can be programmed as low as 30 bpm EXCEPT when Ventricular Capture Control is programmed ON in the Evia HF / HF-T if Bi-V pacing is turned OFF. When Ventricular Capture Control is enabled, the lowest rate Night rate can be programmed is 45 bpm. This is because Ventricular Capture Control requires a “working margin”...
  • Page 29 The blue conflicts show permanent programming conflicts when ventricular capture control (VCC) is programmed ON. These conflicts appear when VCC is programmed ON in single/dual chamber Evia and when RV only pacing is programmed ON in the Evia HF / HF-T. The red conflicts seen in...

  • Page 30: Rate Fading

    Chapter 5 Programmable Parameters Evia HF / HF-T Technical Manual The programmer automatically updates the pulse generator time-of-day clock each time the pulse generator is programmed. The actual time when the respective increase or decrease in rate occurs may begin up to 4 minutes after the programmed time because of internal pulse generator timing.

  • Page 31: Pulse Width

    Pulse width remains constant throughout the service life of the pulse generator. Evia HF / HF-T comes with nine available Pulse Width choices in each chamber, providing a wide variety of choices for pacing management. The Pulse width options are shown in Figure 8.

  • Page 32: Automatic Sensitivity Control (Asc)

    Chapter 5 Programmable Parameters Evia HF / HF-T Technical Manual Figure 8: Pulse Width NOTE: When VCC is programmed to ON or ATM, the pulse width cannot be programmed to a value higher than 0.4 ms. 5.4 Automatic Sensitivity Control (ASC)
  • Page 33 Chapter 5 Programmable Parameters Evia HF / HF-T Technical Manual Figure 9: ensitivity Screens for the Atrium and Ventricles Automatic Sensitivity Control The Automatic Sensitivity Control (ASC) feature automatically measures the peak amplitude and adapts the sensing threshold automatically. After every sensed event, the function starts the detection hold-off period and measures the highest peak of the amplitude.
  • Page 34 Chapter 5 Programmable Parameters Evia HF / HF-T Technical Manual Post Paced Event Summary Following paced events, the Detection Hold-off period is extended slightly in all chambers to prevent oversensing of the paced complex. The step duration is twice that of sensed events to prevent T-wave oversensing.
  • Page 35 Chapter 5 Programmable Parameters Evia HF / HF-T Technical Manual Detection Hold-off Period (DHP) Atrium 120 ms Step Duration 82 ms 2x Step Sensitivity Duratio Threshold from the previous event ½ Fixed Event value Detection Fixed value Minimum Pace Atrium –...

  • Page 36: Ventricular Pacing Parameter Options

    V-V delay after Vs (ms) 0 ms When Trigger pacing is programmed to one of the active modes, the Evia HF / HF-T will deliver a LV pace when an RVs and/or PVC below the maximum trigger rate. PAGE 28...

  • Page 37: Timing Features

    Chapter 5 Programmable Parameters Evia HF / HF-T Technical Manual 5.5 Timing Features Features related to pulse generator timing cycles. 5.5.1 Refractory Periods Immediately upon sensing or pacing, the pulse generator starts a refractory period in the same channel. During the refractory period, intracardiac signals are ignored. This prevents the pulse generator from responding to the depolarization signal or the repolarization signal (T-wave) that might otherwise result in inappropriate inhibition or triggering.

  • Page 38: Auto Pvarp

    Chapter 5 Programmable Parameters Evia HF / HF-T Technical Manual Figure 15: PVARP Timing Table 6 shows the PVARP parameter values and ranges. Parameter Standard Range Units Name Value PVARP AUTO, 175..(5)..600 250 ms PVARP PVARP + 150 ms to a...

  • Page 39: Av Delay

    Table I-Opt available in the Evia HF-T if RV only pacing if programmed Conflict with Sense compensation will arise as a minimum of 15 ms AV Delay is required PAGE 31...

  • Page 40: Av Hysteresis

    Chapter 5 Programmable Parameters Evia HF / HF-T Technical Manual Rate Ranges below 70 bpm 150 ms 70—90 bpm 140 ms 91—110 bpm 130 ms 111—130 bpm 120 ms above 130 bpm 120 ms Table 7: Dynamic AV Delay Settings In addition the Dynamic AV Delays may be programmed individually for each rate range or a fixed AV delay may be programmed for all ranges.

  • Page 41: Av Repetitive Hysteresis

    Chapter 5 Programmable Parameters Evia HF / HF-T Technical Manual AV Setting Medium High 15 ms 85 ms 125 ms 165 ms 50 ms 120 ms 160 ms 200 ms 75 ms 145 ms 185 ms 225 ms 100 ms...

  • Page 42: Av Scan Hysteresis

    Chapter 5 Programmable Parameters Evia HF / HF-T Technical Manual 5.5.4.4 AV Scan Hysteresis With AV Scan Hysteresis enabled, after 180 consecutive pacing cycles, the AV delay is extended for the programmed number of pacing cycles. (1 … 10). If an intrinsic rhythm is detected within the extended AV delay, the longer AV delay remains in effect.

  • Page 43: I-Opt

    Chapter 5 Programmable Parameters Evia HF / HF-T Technical Manual 5.5.4.6 I-Opt I-Opt is a one-button feature designed to promote intrinsic activity in the ventricle. When programmed ON, AV Hysteresis is extended to 400 ms, regardless of the programmed AV Delay. As the heart rate...

  • Page 44: Ventricular Blanking After Ap

    100, 120 and 140 bpm. Evia HF / HF-T allows programming the AV delay settings individually for each of these rate marks 60, 80, 100, 120 and 140 bpm. EasyAV assists the user in programming the AV delay by displaying the...

  • Page 45: Far-Field Protection

    Chapter 5 Programmable Parameters Evia HF / HF-T Technical Manual The blanking time shall be as short as possible in order to provide ventricular sensing when a ventricular depolarization could occur. Crosstalk may be encountered if a shorter blanking time, unipolar ventricular sensing, a higher ventricular sensitivity (lower value) and/or a high atrial pulse amplitude and pulse width are programmed.

  • Page 46: Upper Rate And Utr Response

    Chapter 5 Programmable Parameters Evia HF / HF-T Technical Manual 5.5.8 Upper Rate and UTR Response The upper rate is programmable (up to 200 ppm) for the dual chamber sensing modes [DDD-CLS, DDD(R), VDD(R)], and for all triggered modes (single and dual chamber). The ventricular pacing rate will never exceed the programmed upper rate regardless of the patient’s atrial rate.

  • Page 47: Parameters For Rate-Adaptive Pacing

    Chapter 5 Programmable Parameters Evia HF / HF-T Technical Manual Lead polarity can be programmed separately for sensing and pacing in the atrium and ventricles. Figure 23: LV Pacing Options The programmed lead polarity determines whether the pulse generator senses or paces in a unipolar or bipolar configuration.

  • Page 48: Sensor Gain

    Chapter 5 Programmable Parameters Evia HF / HF-T Technical Manual the stimulation rate. Sensing and inhibition remains in effect during sensor controlled operation. In the case of high pacing rates, however, the refractory periods may cover a majority of the lower rate interval, resulting in asynchronous operation.

  • Page 49: Automatic Sensor Gain

    Chapter 5 Programmable Parameters Evia HF / HF-T Technical Manual exertion is reached during maximum exercise levels. The rate increase, rate decrease and maximum sensor rate settings must be checked for their suitability with respect to the individual patient before adjusting the sensor gain.

  • Page 50: Sensor Threshold

    Chapter 5 Programmable Parameters Evia HF / HF-T Technical Manual Figure 27: Automatic Sensor Gain 5.7.3 Sensor Threshold The effects of rate adaptation are limited to sensor signals exceeding the programmable sensor threshold. Sensor signals below this threshold do not affect rate response (Figure 28).

  • Page 51: Maximum Sensor Rate

    Chapter 5 Programmable Parameters Evia HF / HF-T Technical Manual Increase in Time to Increase Rate (ppm/s) Rate (seconds) Table 11: Rate Increase In DDIR and DVIR, the rate increase is slightly slower than indicated here (depending on the programmed AV interval). The programmed rate increase setting applies only to the increase in pacing rate during sensor-driven operation and does not affect the pacing rate during atrial triggered ventricular pacing.

  • Page 52: Rate Decrease

    5.8 Management of Specific Scenarios 5.8.1 2:1 Lock-In Management 2:1 Lock-In Management is available in Evia HF / HF-T only if biventricular pacing is programmed OFF. 2:1 Lock-In Management is an expansion to the Mode Switch feature. If the AV delay and far-field...

  • Page 53: Atrial Upper Rate

    Chapter 5 Programmable Parameters Evia HF / HF-T Technical Manual Termination The pulse generator will immediately mode switch to a non-atrial tracking mode (e.g., DDDR to DDIR) when the confirmation criteria have been met, and then the 2:1 Lock-In Management feature is suspended until the pulse generator mode switches back to the programmed pacing mode.

  • Page 54: Management Of Specific Scenarios

    Chapter 5 Programmable Parameters Evia HF / HF-T Technical Manual If an intrinsic event is detected during the 20 cycles of pacing, the device will again increase the pacing rate by 8 bpm and start a new 20-cycle interval up to a maximum rate of 120 bpm or MSR.

  • Page 55: Pmt Detection And Termination

    Chapter 5 Programmable Parameters Evia HF / HF-T Technical Manual To prevent occurrence of a PMT, Evia CRT-Ps start an atrial PMT protection interval after each ventricular paced event. If an atrial event is sensed within this PMT protection interval, this will neither start an AV delay nor a basic interval.

  • Page 56: Adjustment Of The Pmt Protection Window

    Chapter 5 Programmable Parameters Evia HF / HF-T Technical Manual Termination Evia CRT-P extends PVARP (Post Ventricular Atrial Refractory Period) to the VA interval + 50 ms. 5.12 Adjustment of the PMT Protection Window The PMT protection window can be automatically adjusted. This automatic adjustment functions in the following manner: When the PMT is detected and terminated, the PMT protection interval is extended by 50 ms.

  • Page 57: Right/Left Ventricular Capture Control Parameters

    Chapter 5 Programmable Parameters Evia HF / HF-T Technical Manual 5.13.2 Right/Left Ventricular Capture Control Parameters Figure 32: Capture Control Screen Capture Control OFF, ON, ATM When Ventricular Capture Control is OFF, the user can manually program the output based on current threshold and physician preference.

  • Page 58: Search Type

    Chapter 5 Programmable Parameters Evia HF / HF-T Technical Manual 5.13.3 Search Type Interval Time of Day This feature determines when the device performs a Ventricular Capture Control test to check the current threshold. • Interval — Interval starts the next Active Threshold Monitoring test at a programmed time from when the previous threshold test was performed.
  • Page 59 Chapter 5 Programmable Parameters Evia HF / HF-T Technical Manual Figure 33: VCC Flow Chart The feature includes three primary components: Signal Analysis, Capture Threshold Search, and Capture Verification. The following paragraphs describe the operation of these three components (SA, ATM, and CV) of VCC while active in DDD(R) pacing mode.
  • Page 60 Chapter 5 Programmable Parameters Evia HF / HF-T Technical Manual • If the first SA after activating VCC is completed successfully, but subsequent SA’s are not completed successfully, then VCC is suspended, and the pacing amplitude is programmed to the last measured threshold plus the safety margin.

  • Page 61: Algorithm Suspension, Abort And Disabling

    Chapter 5 Programmable Parameters Evia HF / HF-T Technical Manual • The algorithm is designed to respond appropriately to fusion beats. In order to discriminate non- capture from fusion, a capture confirmation algorithm varies the AV delay after detection of non- capture in the dual chamber pacing modes.

  • Page 62: Ventricular Capture Control Programming

    Chapter 5 Programmable Parameters Evia HF / HF-T Technical Manual • The ventricular rate is higher than 110 bpm: CV is suspended while the ventricular rate is higher than 110 bpm. When the ventricular rate drops below 110 bpm, CV is resumed.
  • Page 63 Chapter 5 Programmable Parameters Evia HF / HF-T Technical Manual atrial event will be detected either due to the emerging intrinsic rhythm or due to retrograde conducted events caused by ventricular paces. The detection of sensed atrial activity is used to discriminate between atrial capture and non-capture.

  • Page 64: Search Type

    Chapter 5 Programmable Parameters Evia HF / HF-T Technical Manual OFF, ON, ATM When Atrial Capture Control is OFF, the user can manually program the output based on current threshold and physician preference. When Atrial Capture Control is ON, the feature will determine the capture threshold and program the output based on the capture threshold and programmable safety margin.

  • Page 65: Ventricular Pace Suppression (Vp-Suppression)

    Chapter 5 Programmable Parameters Evia HF / HF-T Technical Manual • Time of day — The time of day allows the user to program a specific time of day when the Active Threshold Monitoring test is performed. By default, the time is set to 2:00 A.M. This may be changed if the patient is sensitive to the pacing test occurring at night and may be set to a time when the patient is awake.

  • Page 66: Thoracic Impedance

    Chapter 5 Programmable Parameters Evia HF / HF-T Technical Manual Intelligent Search This feature is designed to prevent frequent searches in patients without stable intrinsic ventricular activity. Each time the search is unsuccessful, the time interval is doubled from the previous interval, up to 128 minutes.
  • Page 67 Chapter 5 Programmable Parameters Evia HF / HF-T Technical Manual ProgramConsult is not an algorithm but uses preset settings based on the recommendations of the ACC/AHA/HRS guidelines for device based therapy. ProgramConsult only shows recommendations for specific parameter settings to the user and clearly highlights them as modifications to the active permanent program prior to making any changes to device programming.

  • Page 68: Home Monitoring (Evia Hf-T)

    Chapter 5 Programmable Parameters Evia HF / HF-T Technical Manual HF with normal HF with HF with low HF with medium HF with high sinus function permanent AF CLS response CLS response CLS response Mode VVI-CLS DDD-CLS DDD-CLS DDD-CLS AV Delay 1...

  • Page 69: Transmission Of Information

    For additional information about the patient device, please refer to its manual. 5.18.3 Transmitting Data The implant’s information is digitally formatted by the BIOTRONIK Service Center and processed into a concise report called a Cardio Report. The Cardio Report, which is adjusted to the individual needs of the patient, contains current and previous implant data.

  • Page 70: Types Of Report Transmissions

    Chapter 5 Programmable Parameters Evia HF / HF-T Technical Manual System Recommendations System Requirements (for Optimal Usage) Screen Resolution 1024 x 768 ≥ 1280 x 1024 ≥ 128 kB/sec Internet Bandwidth 56 kB/sec (DSL, cable modem) 800 MHz Pentium processor, 128 MB RAM ≥...

  • Page 71: Description Of Transmitted Data

    Evia HF / HF-T Technical Manual • Mode Switch episode persisting beyond a programmable time limit NOTE: The attending physician must notify the BIOTRONIK Service Center about which of these events he/ she wishes to be informed. 5.18.5 Description of Transmitted Data The following data are transmitted by the Home Monitoring system, when activated.

  • Page 72: Iegm Online Hds

    • Miscellaneous other information 5.18.5.1 IEGM Online HDs The Evia HF-T provides the ability to transmit periodic IEGM Online HD (IEGM and marker data) from the periodic follow-ups as an addition to the current messages. An IEGM with up to 3 channels (LV, RV and/or RA) are sent in one message.

  • Page 73: Statistics

    Chapter 6 Statistics Evia HF / HF-T Technical Manual 6. Statistics 6.1 Statistics Overview Evia CRT-Ps can store a variety of statistical information. The various statistics consist of such features as rate histograms, event counters, sensor trends, VES statistics, and activity reports, which are described in the following sections.

  • Page 74: General Statistical Information

    Chapter 6 Statistics Evia HF / HF-T Technical Manual 6.1.1 General Statistical Information The Evia CRT-P statistics modes are always in operation and cannot be selected OFF. The counters within the statistic features do not operate when a magnet is applied to the pulse generator.

  • Page 75: Event Sequences

    Chapter 6 Statistics Evia HF / HF-T Technical Manual Figure 35: Event Counters in the Timing Bradycardia Statistics Key Points: LVs is only enabled when the feature LV T-wave protection is turned ON. If this feature is not enabled, the LV pace will show 100% since the device will not have the ability to sense intrinsic LV events.

  • Page 76: Rate Trend 24 Hours

    Chapter 6 Statistics Evia HF / HF-T Technical Manual Figure 36: Event Sequences Show the Percentage of Each of the Pacing States Key points: Event episodes show the distribution of each state of pacing and, in HF-T devices, the distribution of resynchronized ventricular events.
  • Page 77 Chapter 6 Statistics Evia HF / HF-T Technical Manual Figure 37: Rate Trend 24 Hours The Rate Trend 24 hour statistic, shown in Figure 37, counts the number of paced and sensed events and displays the information as a single data point in two different groups (heart rate and paced percentage).

  • Page 78: Rate Trend 240 Days

    Chapter 6 Statistics Evia HF / HF-T Technical Manual 6.2.4 Rate Trend 240 Days Figure 38: Rate Trend 240 Days The Rate trend 240 day statistic, shown in Figure 38, displays data in two different groups (heart rate and paced percentage).

  • Page 79: Atrial And Ventricular Rate Histogram

    Chapter 6 Statistics Evia HF / HF-T Technical Manual 6.2.5 Atrial and Ventricular Rate Histogram Figure 39: Rate Histogram In the Heart Rate Histogram shown in Figure 39, the heart rate range is divided into 36 segments of 10 bpm bins ranging from less than 40 bpm to greater than 380 bpm.

  • Page 80: Arrhythmia Statistics

    Chapter 6 Statistics Evia HF / HF-T Technical Manual 6.3 Arrhythmia Statistics 6.3.1 Atrial Burden Figure 40: Atrial Burden Atrial burden is the percentage of time the patient is in an atrial tachycardia during a given day. The atrial-burden statistic,...

  • Page 81: Time Of Occurrence

    Chapter 6 Statistics Evia HF / HF-T Technical Manual Percent of Atrial Burden is calculated based on the percentage of time out of the total follow-up duration that the patient was in AT/AF episodes. 6.3.2 Time of occurrence The Time of occurrence, shown in...

  • Page 82: Ventricular Arrhythmia

    Chapter 6 Statistics Evia HF / HF-T Technical Manual The Mode Switching graph presents data as the number of mode switch events, as well as their total duration. The intervention rate for mode switch is listed on this page, as well.

  • Page 83: Sensor Statistics

    Chapter 6 Statistics Evia HF / HF-T Technical Manual NOTE: PVC events that have an intrinsic atrial event occurring within 350 ms before the Vs event will be classified as an AsVs event and not a PVC. This is due to the As Discrimination feature of Evia CRT-P, which is a hidden feature of the device.

  • Page 84: Activity Report

    Chapter 6 Statistics Evia HF / HF-T Technical Manual graph to closely match the rate histogram graph. The graph is divided into sixteen 10-beat bins. The duration of recording is displayed on the lower right corner. The user may use the arrow keys, or simply touch on any particular rate within the graph, to review the data.

  • Page 85: Activity

    Chapter 6 Statistics Evia HF / HF-T Technical Manual 6.4.2.2 Activity This value reports any time that the sensor has detected patient activity. Presumably, most of this activity presents normal activities of daily living. Values that may appear too high or too low for that particular patient may represent inappropriate threshold settings for that patient.

  • Page 86: Pacing Amplitude Histogram

    Chapter 6 Statistics Evia HF / HF-T Technical Manual The lead impedance trend, shown in Figure 46, displays the impedance data collected since the last time the statistics were restarted. Impedance data is collected throughout the day, and the average value is displayed for the 24-hour period.

  • Page 87: Capture Control Status

    48, displays the pulse amplitude of each paced event during the recording period. This data is displayed in the respective bins by count and overall percentage. If Evia HF / HF-T is not programmed to ACC/VCC or ATM, this page will only show the programmed output value.

  • Page 88: Sensing Statistics

    Chapter 6 Statistics Evia HF / HF-T Technical Manual • Search pending • Search Delayed by mode switching • Search block by noise • Unstable rates present • Search skipped due to unstable rates • Signal quality insufficient • No stable threshold 6.6 Sensing Statistics...

  • Page 89: Ap-Vs Interval Distribution Curve

    Chapter 6 Statistics Evia HF / HF-T Technical Manual Figure 51: Far-Field Histogram The Far-field histogram in Figure 51 provides information related to sensed events in the atrium occurring after ventricular paced or sensed events. Data is measured in 10 ms intervals. The maximum value measured is 225 ms after a ventricular paced or sensed event.

  • Page 90: Av-Vs Interval Distribution Curve

    Chapter 6 Statistics Evia HF / HF-T Technical Manual The Ap-Vs interval distribution graph in Figure 52 shows the Ap-Vs interval data at different rates. The As-Vs interval is displayed for various rate ranges, labeled by the average heart rate. The programmed AV Delay and AV Hysteresis are shown on the graph.

  • Page 91: Vp Suppression

    Chapter 6 Statistics Evia HF / HF-T Technical Manual 6.6.5 Vp Suppression This section provides information related to the number and amount of Vp suppression that has occurred. Data in this section includes the number of Vp suppression switches and the number of Vs searches for Vp suppression.

  • Page 92: Heart Rate Variability

    6.7.3 Heart Rate Variability Heart Rate Variability, which is the standard deviation of the 5-minute mean normal to normal interval over the recorded time is available in the statistics of the Evia HF / HF-T. This is based on the atrial rate (P-P).

  • Page 93: Iegm Recordings

    • Patient activation (by applying a magnet) • Mode Switches Evia HF-T generators can be programmed to store an IEGM on any or all of the events listed above. However, the programmability of the High Atrial Rate and Mode Switch triggers are linked such that only one trigger can be activated at a time.
  • Page 94 Evia HF-T pulse generators allow a maximum of twenty separate IEGM recordings that each include approximately 10 seconds per event. Upon interrogation of the Evia HF-T pulse generator containing stored IEGMs, a list of the stored IEGMs (with date and time stamp) is displayed under the Holter tab. If the number of events triggering a snapshot is greater than the available memory, the IEGMs will be overwritten according to an internal priority list.

  • Page 95: Other Functions/Features

    Other Functions/Features Evia HF / HF-T Technical Manual 7. Other Functions/Features Evia HF / HF-T pulse generators offer many additional functions and features to assist the physician in the care of the pacemaker patient. 7.1 Safe Program Settings Activating the preset values for the Safe Program is a quick and convenient way to provide VVI pacing at a high output setting in urgent situations.

  • Page 96: Temporary Programming

    • Lead Serial Number • City WARNING Unipolar/Bipolar – Evia HF / HF-T can be used with either unipolar or bipolar IS-1 leads. If the pacing or sensing function is to be programmed to bipolar, it must be verified that bipolar leads have been implanted in that chamber.

  • Page 97: Position Indicator

    Chapter 7 Other Functions/Features Evia HF / HF-T Technical Manual Symptom, etiology and ECG indication are specified using the European PASSPORT code system. The PASSPORT code is an identification system of two character codes that represent specific conditions. A listing of the codes available with definitions is displayed on the screen of the programmer when patient data is selected.
  • Page 98 Chapter 7 Product Storage and Handling Evia HF / HF-T Technical Manual PAGE 90...

  • Page 99: Product Storage And Handling

    (EMI) to avoid damage to the device. Use Before Date – Do not implant the device after the USE BEFORE DATE because the device may have reduced longevity. If a replacement pulse generator is needed, contact your local BIOTRONIK representative. PAGE 91...

  • Page 100: Opening The Sterile Container

    Chapter 8 Product Storage and Handling Evia HF / HF-T Technical Manual 8.2 Opening the Sterile Container The pulse generator is packaged in two plastic containers, one within the other. Each is individually sealed and then sterilized with ethylene oxide. Due to the double packing, the outside of the inner container is sterile and can be removed using standard aseptic technique and placed on the sterile field.

  • Page 101: Lead Connection

    [Reference ISO 5841-3:1992(E)]. BIOTRONIK recommends the use of bipolar pacing leads with new implants so that all of the programmable parameters of Evia CRT-Ps are available for use. Evia CRT-Ps have a self-sealing header.

  • Page 102: Auto Initialization

    Chapter 9 Lead Connection Evia HF / HF-T Technical Manual CAUTION Setscrew Adjustment – Back-off the setscrew(s) prior to insertion of lead connector(s) as failure to do so may result in damage to the lead(s), and/or difficulty connecting lead(s). Cross Threading Setscrew(s) – To prevent cross threading the setscrew(s), do not back the setscrew(s) completely out of the threaded hole.
  • Page 103 Chapter 9 Lead Connection Evia HF / HF-T Technical Manual 2. Detection and Configuration of the Lead Polarity The Evia CRT-P switches the lead polarity to bipolar immediately after a bipolar lead is detected. When the lead impedance is between 100 and 2500 Ohms, the lead connected is classified as bipolar and the sense and pace polarities are set appropriately.
  • Page 104 Chapter 9 Lead Connection Evia HF / HF-T Technical Manual PAGE 96...

  • Page 105: Follow-Up Procedures

    Chapter 10 Follow-up Procedures Evia HF / HF-T Technical Manual 10. Follow-up Procedures 10.1 General Considerations The pacemaker follow-up serves to verify appropriate function of the pacing system, and to optimize the parameter settings. In most instances, pacing system malfunction attributed to causes such as chronic threshold can be corrected by reprogramming the pulse generator.

  • Page 106: Threshold Test

    Chapter 10 Follow-up Procedures Evia HF / HF-T Technical Manual 10.3 Threshold Test Figure 56: Main Threshold Test Screen The atrial and ventricular pacing thresholds are determined using a high-precision threshold test found under the Threshold tab, as illustrated in Figure 56.
  • Page 107 Chapter 10 Follow-up Procedures Evia HF / HF-T Technical Manual The Evia CRT-P allows real-time changes during the threshold tests. The user can now change any of the values while the test is ongoing. If a value is changed, the device will automatically stop the ongoing test and then restart the test with the new value(s).

  • Page 108: P/R Measurement

    Chapter 10 Follow-up Procedures Evia HF / HF-T Technical Manual As the threshold test begins, the selected pacing parameters are transmitted temporarily to the device. These parameters are default parameters (i.e.: the parameters programmed between test parameters) and should be adjusted to guarantee capture. The rate should be programmed above the patient’s intrinsic rate to prevent inhibition.

  • Page 109: Start (Test)

    Chapter 10 Follow-up Procedures Evia HF / HF-T Technical Manual Figure 61: Sensing Test Options 10.4.1 START (test) The Sensing test is performed in a DDI mode with programmable back-up support pacing when the button is selected. Atrial values may be given even if the device is programmed in a VVI(R) mode.

  • Page 110: Mode

    Chapter 10 Follow-up Procedures Evia HF / HF-T Technical Manual 10.4.3 Mode DDI, VVI, AAI and VDD are the available modes for the sensing test The DDI mode provides programmable pacing support during the test and allows the user to measure atrial and ventricular values simultaneously.

  • Page 111: Sensitivity

    The Retrograde conduction test is performed in a VDI mode with a programmable ventricular pacing rate. The Evia HF / HF-T allows the user to choose RV or LV pacing for the Retrograde Conduction test. Select Test mode to display the options (Figure 63).

  • Page 112: Measuring Retrograde Conduction

    Chapter 10 Follow-up Procedures Evia HF / HF-T Technical Manual Figure 65: Retrograde Conduction Test with a Positive Result Retrograde conduction from the ventricle to the atrium can be confirmed when a 1:1 relationship with a constant V-A interval is present. The VA interval is the time between the ventricular paced event and the first subsequent atrial sense.

  • Page 113: Follow-Up History

    Chapter 10 Follow-up Procedures Evia HF / HF-T Technical Manual 10.5.3 Follow-up History The Evia CRT-P can store up to 10 follow-ups. See Figure 66. The first follow-up performed is stored and will not be overwritten to serve as a baseline for future follow-up comparisons. Evia CRT-P stores one follow-up per day.

  • Page 114: Burst Stimulation

    Chapter 10 Follow-up Procedures Evia HF / HF-T Technical Manual 10.6.2 Burst Stimulation Parameter Range Default Coupling Interval Interval from last sensed None, 80...(10)...2000 None event to the first paced event Burst Rate 125...(25)...800 ppm 250 ppm Burst Minimum 125...(25)...800 ppm...

  • Page 115: Back Up Pacing

    10.6.5 NIPS Safety Features The BIOTRONIK offers the following safety features during NIPS sessions. • When the battery voltage has reached the Elective Replacement Indicator point (ERI), the NIPS feature is no longer available.

  • Page 116: Optimizing Rate Adaptation

    Chapter 10 Follow-up Procedures Evia HF / HF-T Technical Manual 10.7 Optimizing Rate Adaptation It is recommended to check the parameters controlling rate adaptation during each follow-up for their individual therapeutic suitability. Any intermediate change in the patient’s general well being and cardiac performance since the last follow-up should be taken into consideration.

  • Page 117: Adjusting The Sensor Threshold

    Chapter 10 Follow-up Procedures Evia HF / HF-T Technical Manual of work load or if the selected maximum sensor rate is achieved at too low of an exercise level, the sensor gain should be reduced by selecting a lower gain setting. If, on the other hand, rate adaptation is insufficient for a specific amount of workload, selection of a higher gain setting may be indicated.
  • Page 118 Chapter 10 Elective Replacement Indication (ERI) Evia HF / HF-T Technical Manual PAGE 110...

  • Page 119: Elective Replacement Indication (Eri)

    Chapter 11 Elective Replacement Indication (ERI) Evia HF / HF-T Technical Manual 11. Elective Replacement Indication (ERI) The service time of Evia CRT-Ps vary based on several factors, including battery properties, storage time, lead system impedance, programmed parameters, amount of pacing and sensing required, and circuit operating characteristics.
  • Page 120 Table 23 shows the expected longevity (in months) from BOS to ERI for the Evia HF / HF-T pulse generators. The programmer software for the Evia HF / HF-T pulse generators provides an estimated time to ERI in months and years that is updated each time the device is reprogrammed. This estimation allows the physician to understand the longevity effects of modifying programmed parameters.

  • Page 121: Explantation

    Explanted pulse generators or explanted accessories may not be reused. Explanted pulse generators can be sent either to the local BIOTRONIK representative or the BIOTRONIK home office for expert disposal. If possible, the explanted pulse generator should be cleaned with a sodium-hyperchlorine solution of at least 1% chlorine and, thereafter, washed with water prior to shipping.
  • Page 122 Chapter 12 Explantation Evia HF / HF-T Technical Manual Source Cause Possible Effect The above plus cardiac tamponade; muscle or Cardiac perforation nerve stimulation. Myocardial irritability at time of insertion, e.g., from an acute Fibrillation myocardial infarction Threshold Elevation Loss of capture and/or sensing.

  • Page 123: Technical Data

    Chapter 13 Technical Data Evia HF / HF-T Technical Manual 13. Technical Data 13.1 Modes DDD-CLS, VVI-CLS, DDDR-ADIR, DDDR, DDIR, DVIR, VDDR, VVIR, AAIR, VDIR, VVTR, AATR, DOOR, VOOR, AOOR NOTE: Programmability dependent on programmer software utilized. Bold parameters indicate factory settings.
  • Page 124 Chapter 13 Technical Data Evia HF / HF-T Technical Manual LV Tip > case LV Ring > case Upper Rate 90…(10)…200 ppm Vp Suppression Off; On Atrial Overdrive Pacing ON; OFF UTR Response WRL; 2:1 (automatic selection) Rate Limitation 8,9,10 190…220 ppm...
  • Page 125 Chapter 13 Technical Data Evia HF / HF-T Technical Manual Automatic; asynchronous; synchronous Asynchronous Magnet Effect: paces at 90 ppm. Automatic Magnet Effect; 10 cycles at 90 ppm asynchronous; thereafter synchronous with the programmed basic rate Synchronous Magnet Effect; synchronous with programmed basic rate Pulse amplitude 0.2...(0.1)...3.0...(0.1)...6.0...(0.5)...7.5 V...

  • Page 126: Rate Adaptation

    Chapter 13 Technical Data Evia HF / HF-T Technical Manual Sense: A unipolar; bipolar unipolar; bipolar unipolar; bipolar 13.2.1 Rate Adaptation Sensor gain 1.0, 1.1, 1.3, 1.4, 1.6, 1.8, 2.0, 2.3, 2.6, 3.0, 3.3, 3.7, 4.0, 4.5, 5.0, 6.0, 7.0, 8.0, 8.5, 10, 11, 13, 14, 16,...

  • Page 127: Right/Left Ventricular Capture Control (Rvcc/Lvcc)

    Chapter 13 Technical Data Evia HF / HF-T Technical Manual 13.2.3 Right/Left Ventricular Capture Control (RVCC/LVCC) Ventricular Capture Control Off, On, ATM Maximum VCC Amplitude 2.4, 3.0, 3.6, 4.2 4.8 V Safety Margin RV - OFF, 0.3…(0.1)…0.5…(0.1)… 1.2 V LV - 1.0 or 1.2 V...

  • Page 128: Additional Functions

    Chapter 13 Technical Data Evia HF / HF-T Technical Manual 13.2.5 Additional Functions NOTE: Availability of the following functions is dependent upon pulse generator configuration. • Temporary Program Activation • High Precision Threshold test in the range up to 7.5 V with 0.1 V resolution •...

  • Page 129: Programmer

    Chapter 13 Technical Data Evia HF / HF-T Technical Manual Burst Burst Chamber Atrium Mode Modes VOO,VVI Rate / ppm 30…200 Back-up Amplitude / V 0.2…7.5 Pacing Pulse width / ms 0.1, 0.2, 0.3, 0.4, 0.5, 0.75, 1.0, 1.25, 1.5...
  • Page 130 Chapter 13 Order Information Evia HF / HF-T Technical Manual PAGE 122...

  • Page 131: Order Information

    Chapter 14 Order Information Evia HF / HF-T Technical Manual 14. Order Information Pulse Generator Type Order Number Evia HF 377 206 Evia HF-T 377 208 FCC Statement: (FCC ID: QRIPRIMUS): This transmitter is authorized by rule under the Medical Device Radiocommunication Service (in part 95 of the FCC Rules) and must not cause harmful interference to stations operating in the 400.150-406.000 MHz band in the Meteorological Aids (i.e.,...
  • Page 132 Chapter 14 Order Information Evia HF / HF-T Technical Manual PAGE 124...

  • Page 133: Appendix A

    Appendix A Mode-Specific Indications and Contraindications Rate-adaptive Pacing Evia HF/HF-T: DDDR, DDDR-ADIR, DDIR, DVIR, VDDR, VVIR, DDD-CLS, VVI-CLS, AAIR, VVTR, DOOR, VOOR, AOOR, AATR, VDIR NOTE: For indications specific to the VDDR mode, see Indications for Use on page 1 (Section 2).
  • Page 134 Appendix A Evia HF / HF-T Technical Manual The DVI mode is clearly indicated if • AV sequential contraction is necessary due to symptomatic bradycardia and slow atrial rate, and/or • a pacemaker syndrome has already been documented. The DVI mode is conditionally indicated for •...
  • Page 135 Appendix A Evia HF / HF-T Technical Manual The VVI mode is contraindicated if • a pacemaker syndrome is known to exist or if the patient develops particular symptoms during temporary pacing or pulse generator implantation, and/or • there is a need to maximize the atrial contribution due to •...
  • Page 136 Appendix A Evia HF / HF-T Technical Manual PAGE 128...

  • Page 137: Appendix B

    Appendix B Evia HF / HF-T Technical Manual Appendix B Known Software Anomalies Possible Effect on Patient or Anomaly Implant Procedure GENERAL PROGRAMMER ISSUES No effect on patient, minor display issue, Missing programmer parameter display rule for PVARP however the system uses the correct parameter (limit of programmed VA limit + 50ms).
  • Page 138 Evia HF / HF-T Technical Manual BIOTRONIK, Inc. 6024 Jean Road Lake Oswego, OR 97035-5369 M4142-B 09/16 (800) 547-0394 (24-hour) © 2016 BIOTRONIK, Inc. All rights reserved. (800) 291-0470 (fax) MN019TEr1 9/1/16 www.biotronik.com...

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