Page 1
Evia HF / HF-T
Techncal Manual
Cardiac Rhythm Management
Heart Failure Therapy
Evia HF / HF-T
Page 2
Evia HF / HF-T
Implantable Pulse Generators
Evia HF / HF-T
X-Ray identication
Radiopaque Identication
A radiopaque identication code is visible on standard x-ray, and identies the pulse generator:
Evia HF / HF-T SF
CAUTION
Because of the numerous available 3.2-mm congurations (e.g., the
IS-1 and VS-1 standards), lead/pulse generator compatibility should
be conrmed with the pulse generator and/or lead manufacturer prior
to the implantation of a pacing system.
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
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
4.5 Home Monitoring ............................................................................................................10
4.6 Electromagnetic Interference (EMI) ................................................................................11
4.6.1 Home and Occupational Environments ......................................................................11
4.6.2 Cellular Phones ..........................................................................................................12
4.6.3 Hospital and Medical Environments ...........................................................................12
4.7 Pulse Generator Explant and Disposal ..........................................................................12
5. Programmable Parameters ................................................................................................13
5.1 Pacing Modes .................................................................................................................13
5.1.1 Motion Based Rate-Adaptive Modes ..........................................................................13
5.1.2 CLS Modes.................................................................................................................13
5.1.3 Non-Rate-Adaptive Modes .........................................................................................14
5.1.4 Mode Switching ..........................................................................................................14
5.1.5 Pacing Modes with Triggered Response ....................................................................16
5.2 Rate Related Functions ..................................................................................................17
5.2.1 Basic Rate ..................................................................................................................17
5.2.2 Rate Hysteresis ..........................................................................................................18
5.2.3 Scan Hysteresis .........................................................................................................19
5.2.4 Repetitive Hysteresis..................................................................................................19
5.2.5 Night Mode .................................................................................................................20
5.2.6 Rate Fading ................................................................................................................22
5.3 Pulse Specic Features ..................................................................................................22
5.3.1 Pulse Amplitude..........................................................................................................22
5.3.2 Pulse Width ................................................................................................................23
5.4 Automatic Sensitivity Control (ASC) ...............................................................................24
5.4.1 Ventricular Pacing Parameter Options .......................................................................28
5.5 Timing Features ..............................................................................................................29
5.5.1 Refractory Periods......................................................................................................29
5.5.2 Atrial Refractory Period ..............................................................................................29
5.5.3 PVARP .......................................................................................................................29
5.5.3.1 AUTO PVARP .........................................................................................................30
5.5.3.2 Right Ventricular Refractory Period ........................................................................30
5.5.3.3 Left Ventricular Refractory Period ..........................................................................30
5.5.4 AV Delay .....................................................................................................................31
PAGE i
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
5.5.6 Far-Field Protection ....................................................................................................37
5.5.7 Safety AV Delay ..........................................................................................................37
5.5.8 Upper Rate and UTR Response ................................................................................38
5.6 Lead Polarity ..................................................................................................................38
5.7 Parameters for Rate-Adaptive Pacing ............................................................................39
5.7.1 Sensor Gain ...............................................................................................................40
5.7.2 Automatic Sensor Gain...............................................................................................41
5.7.3 Sensor Threshold .......................................................................................................42
5.7.4 Rate Increase .............................................................................................................42
5.7.5 Maximum Sensor Rate ...............................................................................................43
5.7.6 Maximum Closed Loop Rate ......................................................................................43
5.7.7 Rate Decrease ...........................................................................................................44
5.8 Management of Specic Scenarios ................................................................................44
5.8.1 2:1 Lock-In Management............................................................................................44
5.9 Atrial Upper Rate ............................................................................................................45
5.10 Atrial Overdrive Pacing (Overdrive Mode) ....................................................................45
5.11 Management of Specic Scenarios ..............................................................................46
5.11.1 PMT Management ....................................................................................................46
5.11.2 PMT Protection .........................................................................................................46
5.11.2.1 PMT Detection and Termination ...........................................................................47
5.12 Adjustment of the PMT Protection Window ..................................................................48
5.13 Right/left Ventricular Capture Control (VCC) ................................................................48
5.13.1 Feature Description ..................................................................................................48
5.13.2 Right/Left Ventricular Capture Control Parameters ..................................................49
5.13.3 Search Type .............................................................................................................50
5.13.3.1 Algorithm Suspension, Abort and Disabling .........................................................53
5.13.4 Ventricular Capture Control Programming ...............................................................54
5.14 Atrial Capture Control (ACC) ........................................................................................54
5.14.1 Feature Description ..................................................................................................54
5.14.2 Search Type .............................................................................................................56
5.15 Ventricular Pace Suppression (Vp-Suppression) .........................................................57
5.15.1 Feature Description ..................................................................................................57
5.15.2 Programmability .......................................................................................................57
5.15.3 How the Vp Suppression Algorithm Works ...............................................................57
5.16 Thoracic Impedance .....................................................................................................58
5.17 ProgramConsult® .........................................................................................................58
PAGE ii
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
5.18.5.1 IEGM Online HDs .................................................................................................64
6. Statistics ..............................................................................................................................65
6.1 Statistics Overview .........................................................................................................65
6.1.1 General Statistical Information ...................................................................................66
6.2 Timing Statistics .............................................................................................................66
6.2.1 Event Counter ............................................................................................................66
6.2.2 Event Sequences .......................................................................................................67
6.2.3 Rate Trend 24 Hours ..................................................................................................68
6.2.4 Rate Trend 240 Days .................................................................................................70
6.2.5 Atrial and Ventricular Rate Histogram ........................................................................71
6.3 Arrhythmia Statistics .......................................................................................................72
6.3.1 Atrial Burden ...............................................................................................................72
6.3.2 Time of occurrence .....................................................................................................73
6.3.3 Mode Switching ..........................................................................................................73
6.3.4 Ventricular Arrhythmia ................................................................................................74
6.4 Sensor Statistics .............................................................................................................75
6.4.1 Sensor Histogram.......................................................................................................75
6.4.2 Activity Report ............................................................................................................76
6.4.2.1 No Activity...............................................................................................................76
6.4.2.2 Activity ....................................................................................................................77
6.4.2.3 Max Sensor Rate....................................................................................................77
6.5 Pacing Statistics .............................................................................................................77
6.5.1 Lead Impedance Trends with Lead Check .................................................................77
6.5.2 Pacing Amplitude Histogram ......................................................................................78
6.5.3 Pacing Threshold Trend .............................................................................................78
6.5.4 Capture Control Status ...............................................................................................79
6.6 Sensing Statistics ...........................................................................................................80
6.6.1 P- and R-wave Trends................................................................................................80
1.1.1 Far-eld Histogram ....................................................................................................80
6.6.2 Ap-Vs interval distribution curve .................................................................................81
6.6.3 Av-Vs interval distribution curve .................................................................................82
6.6.4 Vp Suppression ..........................................................................................................83
6.7 Heart Failure Monitoring Statistics .................................................................................83
6.7.1 Mean Heart Rate ........................................................................................................83
6.7.2 Mean Heart Rate at Rest............................................................................................83
PAGE iii
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
7.2.2 Asynchronous Magnet Effect ......................................................................................87
7.2.3 Synchronous Magnet Effect .......................................................................................87
7.3 Temporary Programming ................................................................................................88
7.4 Patient Data Memory ......................................................................................................88
7.5 Position Indicator ............................................................................................................89
7.6 Pacing When Exposed to Interference ...........................................................................89
8. Product Storage and Handling ..........................................................................................91
8.1 Sterilization and Storage ................................................................................................91
8.2 Opening the Sterile Container ........................................................................................92
8.3 Pulse Generator Orientation ...........................................................................................92
9. Lead Connection .................................................................................................................93
9.1 Auto Initialization ............................................................................................................94
10. Follow-up Procedures ......................................................................................................97
10.1 General Considerations ................................................................................................97
10.2 Real-time IEGM Transmission .....................................................................................97
10.3 Threshold Test ..............................................................................................................98
10.4 P/R Measurement ......................................................................................................100
10.4.1 START (test) ...........................................................................................................101
10.4.2 Intrinsic Rhythm (test) ............................................................................................101
10.4.3 Mode .....................................................................................................................102
10.4.4 Sensing test parameters ........................................................................................102
10.4.4.1 Basic Rate ..........................................................................................................102
10.4.4.2 AV Delay .............................................................................................................102
10.4.4.3 Upper Rate .........................................................................................................102
10.4.4.4 Report.................................................................................................................102
10.4.4.5 Pulse Amplitude..................................................................................................102
10.4.4.6 Pulse Width ........................................................................................................102
10.4.4.7 Sensitivity ...........................................................................................................103
10.4.4.8 Pacing Polarity ...................................................................................................103
10.4.4.9 Sensing Polarity .................................................................................................103
10.5 Testing for Retrograde Conduction .............................................................................103
10.5.1 Measuring Retrograde Conduction ........................................................................104
10.5.2 Requirements for Measurement .............................................................................104
10.5.3 Follow-up History....................................................................................................105
10.6 Atrial Non-Invasive Programmed Stimulation (NIPS) .................................................105
PAGE iv
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
11. Elective Replacement Indication (ERI).......................................................................... 111
12. Explantation ....................................................................................................................113
12.1 Common Reasons to Explant a Pulse Generator ......................................................113
13. Technical Data .................................................................................................................115
13.1 Modes ......................................................................................................................... 11 5
13.2 Pulse- and Control Parameters ..................................................................................115
13.2.1 Rate Adaptation ......................................................................................................118
13.2.2 Atrial Capture Control (ACC) ..................................................................................118
13.2.3 Right/Left Ventricular Capture Control (RVCC/LVCC) 119
13.2.4 Home Monitoring Parameters ................................................................................119
13.2.5 Additional Functions ...............................................................................................120
13.2.6 NIPS Specications ................................................................................................120
13.3 Programmer ...............................................................................................................121
13.4 Materials in Contact with Human Tissue ....................................................................121
13.5 Electrical Data/Battery ................................................................................................121
13.6 Mechanical Data .........................................................................................................121
14. Order Information ...........................................................................................................123
Appendix A .............................................................................................................................125
Appendix B .............................................................................................................................129
CAUTION
Federal (U.S.A.) law restricts this device to sale by, or on the order of,
a physician (or properly licensed practitioner).
PAGE v
Page 8
Chapter Table of Contents
Evia HF / HF-T Technical Manual
PAGE vi
Page 9
Chapter 1 Device Description
Evia HF / HF-T Technical Manual
1. 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.
The basic function of CLS involves the translation of myocardial contractility into patient-specic
pacing rates. Specically, the pulse generator monitors and processes the intracardiac impedance
signals associated with myocardial contraction dynamics. Changes in the waveform of this impedance
signal are associated with changes in the contraction dynamics of the patient’s heart due to the
heart’s inotropic response to exercise and acute mental stress. By monitoring these changes, the
pulse generator can provide a pacing rate that is appropriate and specic to the patient’s individual
physiologic demands due to exercise and acute mental stress.
For standard motion-based rate-adaptation, the Evia HF / HF-T is equipped with an accelerometer
located within the pulse generator. This sensor produces an electric signal during physical activity of the
patient. If a rate-adaptive (R) mode is programmed, then the accelerometer sensor signal controls the
stimulation rate.
Evia HF-T also employs Home Monitoring™ technology, which is an automatic, wireless, remote
monitoring system for management of patients with pulse generators. With Home Monitoring,
physicians can review data about the patient’s cardiac status and pulse generator’s functionality
between regular follow-up visits, allowing the physician to optimize the therapy process.
BIOTRONIK conducted the TRUST study to evaluate the safety and effectiveness of Home Monitoring.
With the TRUST study, BIOTRONIK was able to show the following with regards to Home Monitoring:
• BIOTRONIK Home Monitoring information may be used as a replacement for device interrogation
during in-office follow-up visits.
• A strategy of care using BIOTRONIK Home Monitoring with office visits when needed has been
shown to extend the time between routine, scheduled in-office follow-ups of BIOTRONIK
implantable devices in many patients. Home Monitoring data is helpful in determining the need for
additional in-office follow-up.
• BIOTRONIK Home Monitoring-patients—who are followed remotely with office visits when
needed—have been shown to have similar numbers of strokes, invasive procedures and deaths as
patients followed with conventional in-office follow-ups.
• BIOTRONIK Home Monitoring provides early detection of arrhythmias.
• BIOTRONIK Home Monitoring provides early detection of silent, asymptomatic arrhythmias.
• Automatic early detection of arrhythmias and device system anomalies by BIOTRONIK Home
Monitoring allows for earlier intervention than conventional in-office follow-ups.
• BIOTRONIK Home Monitoring allows for improved access to patient device data compared to
conventional in-office follow-ups since device interrogation is automatically scheduled at
regular intervals.
Evia HF / HF-T provides three chamber pacing in a variety of rate-adaptive and non-rate adaptive
pacing modes. Pacing capability is supported by a sophisticated diagnostic set.
The device is designed and recommended for use with atrial and ventricular unipolar or bipolar leads
having IS-1 compatible connectors. (Note that IS-1 refers to the International Standard whereby leads
and generators from different manufacturers are assured a basic t [Reference ISO 5841-3:1992]).
PAGE 1
Page 10
Chapter 1 Device Description
Evia HF / HF-T Technical Manual
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.
Evia HF
Triple chamber, rate-adaptive, unipolar/
bipolar pacing CRT-P
Triple chamber, rate-adaptive, unipolar/
Evia HF-T
bipolar pacing CRT-P with Home
Monitoring
Throughout this manual, specic feature and function descriptions may only be applicable to the Evia
HF-T and those features will be referenced as such. Otherwise, reference to Evia CRT-Ps refers to
both devices.
PAGE 2
Page 11
Chapter 2 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 3
Page 12
Chapter 2 Indications
Evia HF / HF-T Technical Manual
PAGE 4
Page 13
Chapter 3 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.
• Single chamber atrial pacing is contraindicated for patients with impaired AV nodal conduction.
• Dual chamber and single chamber atrial pacing is contraindicated for patients with chronic
refractory atrial tachyarrhythmias.
For a complete discussion of mode-specic contraindications, please refer to Appendix A of this
manual.
PAGE 5
Page 14
Chapter 3 Contraindications
Evia HF / HF-T Technical Manual
PAGE 6
Page 15
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:
Magnetic Resonance Imaging (MRI) Avoid use of magnetic resonance imaging as it has been
shown to cause movement of the pulse generator within the subcutaneous pocket and may cause pain
and injury to the patient and damage to the pulse generator. If the procedure must be used, constant
monitoring is recommended, including monitoring the peripheral pulse.
Rate-Adaptive Pacing Use rate-adaptive pacing with care in patients unable to tolerate increased
pacing rates.
High Output Settings High output settings combined with extremely low lead impedance may reduce
the life expectancy of the pulse generator to less than 1 year. Programming of pulse amplitudes, higher
than 4.8 V, in combination with long pulse widths and/or high pacing rates may lead to premature
activation of the replacement indicator.
4.1 Medical Therapy
Before applying one of the following procedures, a detailed analysis of the advantages and risks
should be made. Cardiac activity during one of these procedures should be conrmed by continuous
monitoring of peripheral pulse or blood pressure. Following the procedures, pulse generator function
and stimulation threshold must be checked.
Therapeutic Diathermy Equipment Use of therapeutic diathermy equipment is to be avoided for
pacemaker patients due to possible heating effects of the pulse generator and at the implant site.
If diathermy therapy must be used, it should not be applied in the immediate vicinity of the pulse
generator/lead. The patient’s peripheral pulse should be monitored continuously during the treatment.
Transcutaneous Electrical Nerve Stimulation (TENS) Transcutaneous electrical nerve stimulation
may interfere with pulse generator function. If necessary, the following measures may reduce the
possibility of interference:
• Place the TENS electrodes as close to each other as possible.
• Place the TENS electrodes as far from the pulse generator/lead system as possible.
• Monitor cardiac activity during TENS use.
Debrillation The following precautions are recommended to minimize the inherent risk of pulse
generator operation being adversely affected by debrillation:
• The paddles should be placed anterior-posterior or along a line perpendicular to the axis formed by
the pulse generator and the implanted lead.
• The energy setting should not be higher than required to achieve defibrillation.
• The distance between the paddles and the pacer/electrode(s) should not be less than 10 cm
(4 inches).
Radiation Pulse generator electronics may be damaged by exposure to radiation during radiotherapy.
To minimize this risk when using such therapy, the pulse generator should be protected with local
radiation shielding.
Lithotripsy Lithotripsy treatment should be avoided for pacemaker patients since electrical and/
or mechanical interference with the pulse generator is possible. If this procedure must be used, the
greatest possible distance from the point of electrical and mechanical strain should be chosen in order
to minimize a potential interference with the pulse generator.
PAGE 7
Page 16
Chapter 4 Warnings and Precautions
Evia HF / HF-T Technical Manual
Electrocautery Electrocautery should never be performed within 15 cm (6 inches) of an implanted
pulse generator or lead because of the danger of introducing brillatory currents into the heart and/
or damaging the pulse generator. Pacing should be asynchronous and above the patient’s intrinsic
rate to prevent inhibition by interference signals generated by the cautery. When possible, a bipolar
electrocautery system should be used.
For transurethral resection of the prostate, it is recommended that the cautery ground plate be placed
under the buttocks or around the thigh, but not in the thoracic area where the current pathway could
pass through or near the pacing system.
4.2 Storage and Sterilization
Storage (temperature) Recommended storage temperature range is -10° to 45°C (14°-113°F).
Exposure to temperatures outside this range may result in pulse generator malfunction (see
Section 8.1).
Handling Do not drop. If an unpackaged pulse generator is dropped onto a hard surface, return it to
BIOTRONIK (see Section 8.1).
FOR SINGLE USE ONLY Do not resterilize the pulse generator or accessories packaged with the
pulse generator, they are intended for one-time use.
Device Packaging Do not use the device if the packaging is wet, punctured, opened or damaged
because the integrity of the sterile packaging may be compromised. Return the device to BIOTRONIK.
Storage (magnets) Store the device in a clean area, away from magnets, kits containing magnets,
and sources of electromagnetic interference (EMI) to avoid damage to the device.
Temperature Stabilization Allow the device to reach room temperature before programming or
implanting the device. Temperature extremes may affect the initial device function.
Use Before Date Do not implant the device after the USE BEFORE DATE because the device sterility
and longevity may be compromised.
4.3 Lead Connection and Evaluation
The pulse generator requires atrial and ventricular leads with IS-1 compatible connectors. There are
no requirements specic to the atrial lead. 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 Debrillator (ICD).
Lead/pulse Generator Compatibility Because of the numerous available 3.2-mm congurations (e.g.,
the IS-1 and VS-1 standards), lead/pulse generator compatibility should be conrmed with the pulse
generator and/or lead manufacturer prior to the implantation of a pacing system.
IS-1, wherever stated in this manual, refers to the international standard, whereby leads and generators
from different manufacturers are assured a basic t. [Reference ISO 5841-3:1992(E)].
Lead Conguration Lead conguration determines proper programming of the pulse generator. Pacing
will not occur with a unipolar lead if the lead conguration is programmed to bipolar (see Section 9).
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 difculty connecting lead(s).
PAGE 8
Page 17
Chapter 4 Warnings and Precautions
Evia HF / HF-T Technical Manual
Cross Threading Setscrew(s) To prevent cross threading the setscrew(s), do not back the
setscrew(s) completely out of the threaded hole. 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. Failure to do so may result in damage to the plug and its
self-sealing properties.
4.4 Programming and Operation
Negative AV Delay Hysteresis This feature insures ventricular pacing, a technique which has been
used in patients with hypertrophic obstructive cardiomyopathy (HOCM) with normal AV conduction
in order to replace intrinsic ventricular activation. No clinical study was conducted to evaluate this
feature, and there is conicting evidence regarding the potential benet of ventricular pacing therapy
for HOCM patients. In addition, there is evidence with other patient groups to suggest that inhibiting
the intrinsic ventricular activation sequence by right ventricular pacing may impair hemodynamic
function and/or survival.
Programming VCC If lead polarization check is not successful, program another pulse width on test
start amplitude. If still unsuccessful, program the pacing pulse amplitude manually.
NIPS Life threatening ventricular arrhythmias can be induced by stimulation in the atrium. Ensure
that an external cardiac debrillator is easily accessible. Only physicians trained and experienced in
tachycardia induction and reversion protocols should use non-invasive programmed stimulation (NIPS).
Unipolar/Bipolar All Evia CRT-P models 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 veried that bipolar leads
have been implanted in that chamber. If either of the leads is unipolar, unipolar sensing and pacing
functions must be programmed in that chamber. Failure to program the appropriate lead conguration
could result in entrance and/or exit block.
Programmers Use only appropriate BIOTRONIK programmers equipped with appropriate software to
program Evia CRT-Ps. Do not use programmers from other manufacturers.
Pulse Amplitude Programming of pulse amplitudes, higher than 4.8 V, in combination with long pulse
widths and/or high pacing rates can lead to premature activation of the replacement indicator.
Pacing thresholds When decreasing programmed output (pulse amplitude and/or pulse width),
the pacing threshold must rst be accurately assessed to provide a 2:1 safety margin. When using
the Ventricular Capture Control feature, the device will automatically set the output to the measured
threshold plus the programmed Safety Margin. A new threshold search will occur at scheduled intervals
or upon loss of capture.
EMI Computerized systems are subject to EMI or “noise”. In the presence of such interference,
telemetry communication may be interrupted and prevent programming.
Programming Modications 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.
Short Pacing Intervals Use of short pacing intervals (high pacing rates) with long atrial and/or
ventricular refractory periods may result in intermittent asynchronous pacing and, therefore, may be
contraindicated in some patients.
PAGE 9
Page 18
Chapter 4 Warnings and Precautions
Evia HF / HF-T Technical Manual
OFF Mode Use of the OFF mode should be avoided in pacemaker dependent patients. The OFF mode
can be transmitted as a temporary program only to permit evaluation of the patient’s spontaneous rhythm.
Myopotential Sensing The lter characteristics of BIOTRONIK pulse generators have been optimized
to sense electrical potentials generated by cardiac activity and to reduce the possibility of sensing
skeletal myopotentials. However, the risk of pulse generator operation being affected by myopotentials
cannot be eliminated, particularly in unipolar systems. Myopotentials may resemble cardiac activity,
resulting in pulse generator pulse inhibition, triggering and/or emission of asynchronous pacing pulses,
depending on the pacing mode and the interference pattern. Certain follow-up procedures, such as
monitoring pulse generator performance while the patient is doing exercises involving the use of
pectoral muscles, as well as Holter monitoring, have been recommended to check for interference
caused by myopotentials. If sensing of myopotentials is encountered, corrective actions may include
selection of a different pacing mode or sensitivity.
Muscle or Nerve Stimulation Inappropriate muscle or nerve stimulation may occur with unipolar
pacing when using a non-coated pulse generator.
CLS Rate-Adaptation Under certain circumstances (e.g., EMI, lead dislodgment), the Evia CRT-P
device may not be able to obtain a useable impedance measurement as required for CLS rate-adaptive
pacing. At this point, CLS rate-adaptation will be inactive until the situation is corrected. Rate-adaptation
may be programmed to switch to motion based adaptation.
Programmed to Triggered Modes When programmed to triggered modes, pacing rates up to the
programmed upper limit may occur in the presence of either muscle or external interference.
Triggered Modes While the triggered modes (DDT, VVT, and AAT) can be programmed permanently,
the use of these modes is intended as a temporary setting in situations where maintaining the
programming head in place would be impossible or impractical (i.e., during exercise testing or extended
Holter monitoring) or as a short term solution to pulse generator inhibition by extracardiac interference.
To avoid the potential for early battery depletion, it is important that the triggered modes are not used
for long term therapy, and that the pulse generator is returned to a non-triggered permanent program.
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:
• The patient’s CardioMessenger is off or damaged and is not able to connect to the Home
Monitoring system through an active telephone link.
• The CardioMessenger cannot establish a connection to the implanted device.
• The telephone and/or Internet connection do not operate properly
• The Home Monitoring Service Center is off-line (upgrades are typically completed in less than
24 hours)
Patient’s Ability Use of the Home Monitoring system requires the patient and/or caregiver to follow
the system instructions and cooperate fully when transmitting data.
If the patient cannot understand or follow the instructions because of physical or mental challenges,
another adult who can follow the instructions will be necessary for proper transmission.
Electromagnetic Interference (EMI) Precautions for EMI interference with the Evia CRT-Ps are
provided in Section 4.6. Sources of EMI including cellular telephones, electronic article surveillance
systems, and others are discussed therein.
PAGE 10
Page 19
Chapter 4 Warnings and Precautions
Evia HF / HF-T Technical Manual
Use in Cellular Phone Restricted Areas The mobile patient device (transmitter/receiver) should not
be utilized in areas where cellular phones are restricted or prohibited (i.e., commercial aircraft).
4.6 Electromagnetic Interference (EMI)
The operation of any implanted pulse generator may be affected by certain environmental sources
generating signals that resemble cardiac activity. This may result in pulse generator pulse inhibition
and/or triggering or in asynchronous pacing depending on the pacing mode and the interference
pattern. In some cases (i.e., diagnostic or therapeutic medical procedures), the interference sources
may couple sufcient energy into a pacing system to damage the pulse generator and/or cardiac tissue
adjacent to the electrodes.
BIOTRONIK pulse generators have been designed to signicantly reduce susceptibility to
electromagnetic interference (EMI). However, due to the variety and complexity of sources creating
interference, there is no absolute protection against EMI. Generally, it is assumed that EMI produces
only minor effects, if any, in pacemaker patients. If the patient presumably will be exposed to one of the
following environmental conditions, then the patient should be given the appropriate warnings.
4.6.1 Home and Occupational Environments
The following equipment (and similar devices) may affect normal pulse generator operation: electric arc
welders, electric melting furnaces, radio/television and radar transmitters, power-generating facilities,
high-voltage transmission lines, electrical ignition systems (also of gasoline-powered devices) if
protective hoods, shrouds, etc., are removed, electrical tools, anti-theft devices of shopping centers and
electrical appliances, if not in proper condition or not correctly grounded and encased.
Patients should exercise reasonable caution in avoidance of devices which generate a strong electric
or magnetic eld. If EMI inhibits operation of a pulse generator or causes it to revert to asynchronous
operation at the programmed pacing rate or at the magnet rate, moving away from the source or
turning it off will allow the pulse generator to return to its normal mode of operation. Some potential EMI
sources include:
High Voltage Power Transmission Lines High voltage power transmission lines may generate
enough EMI to interfere with pulse generator operation if approached too closely.
Home Appliances Home appliances normally do not affect pulse generator operation if the appliances
are in proper condition and correctly grounded and encased. There are reports of pulse generator
disturbances caused by electrical tools and by electric razors that have touched the skin directly over
the pulse generator.
Communication Equipment Communication equipment such as microwave transmitters, linear
power ampliers, or high-power amateur transmitters may generate enough EMI to interfere with pulse
generator operation if approached too closely.
Commercial Electrical Equipment Commercial electrical equipment such as arc welders, induction
furnaces, or resistance welders may generate enough EMI to interfere with pulse generator operation if
approached too closely.
Electrical Appliances Electric hand-tools and electric razors (used directly over the skin of the pulse
generator) have been reported to cause pulse generator disturbances. Home appliances that are in
good working order and properly grounded do not usually produce enough EMI to interfere with pulse
generator operation.
PAGE 11
Page 20
Chapter 4 Warnings and Precautions
Evia HF / HF-T Technical Manual
Electronic Article Surveillance (EAS) Equipment such as retail theft prevention systems may interact
with the pulse generators. Patients should be advised to walk directly through and not to remain near
an EAS system longer than necessary.
4.6.2 Cellular Phones
Recent studies have indicated there may be a potential interaction between cellular phones and pulse
generator operation. Potential effects may be due to either the radio frequency signal or the magnet
within the phone and could include inhibition or asynchronous pacing when the phone is within close
proximity (within 6 inches [15 centimeters]) to the pulse generator.
Based on testing to date, effects resulting from an interaction between cellular phones and the
implanted pulse generators have been temporary. Simply moving the phone away from the implanted
device will return it to its previous state of operation. Because of the great variety of cellular phones
and the wide variance in patient physiology, an absolute recommendation to cover all patients cannot
be made.
Patients having an implanted pulse generator who operate a cellular phone should:
• Maintain a minimum separation of 6 inches (15 centimeters) between a hand-held personal cellular
phone and the implanted device. Portable and mobile cellular phones generally transmit at higher
power levels compared to hand held models. For phones transmitting above 3 watts, maintain a
minimum separation of 12 inches (30 centimeters) between the antenna and the implanted device.
• Patients should hold the phone to the ear opposite the side of the implanted device. Patients
should not carry the phone in a breast pocket or on a belt over or within 6 inches (15 centimeters)
of the implanted device as some phones emit signals when they are turned ON but not in use (i.e.,
in the listen or standby mode). Store the phone in a location opposite the side of implant.
4.6.3 Hospital and Medical Environments
Electrosurgical Cautery Electrosurgical cautery could induce ventricular arrhythmias and/or
brillation, or may cause asynchronous or inhibited pulse generator operation. If use of electrocautery
is necessary, the current path (ground plate) should be kept as far away from the pulse generator and
leads as possible.
Lithotripsy Lithotripsy may damage the pulse generator. If lithotripsy must be used, do not focus the
beam near the pulse generator.
External Debrillation External debrillation may damage the pulse generator. Attempt to minimize
current owing through the pulse generator and lead system by following the precautions.
High Radiation Sources High radiation sources such as cobalt 60 or gamma radiation should not
be directed at the pulse generator. If a patient requires radiation therapy in the vicinity of the pulse
generator, place lead shielding over the device to prevent radiation damage.
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
Chapter 5 Programmable Parameters
Evia HF / HF-T Technical Manual
5. 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
NOTE:
Ventricular Capture Control is only available with the following pacing modes: DDD-CLS, VVI-CLS,
DDDR, VDDR, VVIR, DDD, VDD, VVI, DDD-ADI, and DDDR-ADIR.
5.1.1 Motion Based Rate-Adaptive Modes
The motion based rate-adaptive modes are designated with an “R” in the fourth position of the NBG
pacemaker code on the programmer screen. The rate-adaptive modes function identically to the
corresponding non-rate-adaptive modes, except that the basic rate increases when physical activity is
detected by the motion sensor.
In demand modes (DDDR, DDIR, DVIR, VDDR, VVIR, AATR, VVTR, VDIR, AAIR), it is possible that
the atrial and/or ventricular refractory period can comprise a major portion of the basic interval at high
sensor-modulated rates. This may limit the detection of spontaneous events or even exclude their
recognition altogether. Further details of this potential occurrence are provided in Section 5.5.1.
5.1.2 CLS Modes
As explained in the device description, Evia CRT-P also can be programmed to use a unique rateadaptive principle called Closed Loop Stimulation (CLS) to adapt the patient’s pacing rate.
The Evia CRT-P measures electrical impedance by injecting a small AC current between the pulse
generator case and the ventricular electrode tip. The induced voltage (which is proportional to the
intracardiac impedance) is also measured between pulse generator case and ventricular electrode tip.
PAGE 13
Page 22
Chapter 5 Programmable Parameters
Evia HF / HF-T Technical Manual
CAUTION
Rate-Adaptive Pacing Use rate-adaptive pacing with care in patients
unable to tolerate increased pacing rates.
CLS Rate Adaptation Under certain circumstances (e.g., EMI, lead
dislodgment), the Evia CRT-P device may not be able to obtain a
useable impedance measurement as required for CLS rate-adaptive
pacing. At this point, CLS rate-adaptation will be inactive until the
situation is corrected. Rate-adaptation may be programmed to switch
to motion based adaptation.
The DDD-CLS and VVI-CLS mode is functionally equivalent to the DDDR and VVIR pacing modes,
respectively. However these modes use the CLS concept to determine the pacing rate variations that
are mediated by the body’s own cardiovascular control. In these modes, the atrial and/or ventricular
refractory periods may comprise a major portion of the basic interval at high rates. This could limit
the detection of spontaneous events or even exclude their recognition altogether. However, this
phenomenon will not limit the functionality of the mode switch.
Motion based rate adaptive pacing will take over if the CLS pacing algorithm switches into a
passive mode.
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.
Mode Switching is designed to avoid tracking of non-physiologic atrial rates due to paroxysmal atrial
tachycardias (PATs). Mode Switching is only available in atrial tracking modes DDD(R), VDD(R), DDDCLS, and DDDR-ADIR.
Table 1 is a summary of the parameters associated with Mode Switching.
Parameter Range Default Setting
Mode Switching ON, OFF ON
Intervention Rate 100...(10)...250 bpm 160 bpm
Switch to
Ventricular Pacing Biv/RV Biv
Onset Criterion 3...(1)...8 5
Resolution Criterion 3...(1)...8 5
Dependent on Basic
Mode Setting
DDIR
PAGE 14
Basic Rate during
mode Switching
Rate stabilization
during mode switching
2:1 Lock-in Protection ON, OFF ON
OFF, +5...(+5)...+30 +10
ON, OFF OFF
Page 23
Chapter 5 Programmable Parameters
Evia HF / HF-T Technical Manual
Table 1: Mode Switching Parameter Summary
Intervention rate
The Intervention rate is the minimum atrial rate at which Mode Switching will occur and is
programmable by the user.
Switch to Pacing
Switch to pacing is the mode the device reverts to during Mode Switch.
Table 2 shows the choices for Mode Switch modes based on the programmed device mode.
Programmed
Device Mode
Mode Switch
Mode Options
Default Mode for
Mode Switch
DDDR-ADIR DDIR DDIR
DDD-ADI DDI,DDIR DDIR
DDD-CLS DDIR DDIR
DDDR DDIR DDIR
DDD DDI, DDIR DDIR
VDDR VDIR VDIR
VDD VDI, VDIR 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.
Onset Criterion
The mode switch onset criterion uses an X of 8 rolling counter with a default X value of 5. This means
that 5 out of the last 8 atrial events must be faster than the programmed intervention rate for Mode
Switch to occur.
The higher the X value, the harder it is to declare Mode Switching. Conversely, the lower the value, the
easier it is for Mode Switching to occur.
Atrial oversensing due to far-eld events sensed in the atrial channel may lead to inappropriate Mode
Switch declaration.
Evia CRT-P does not use intervals with paced events towards the mode switch count, thereby reducing
the risk of inappropriate mode switch due to sensor competition.
Resolution Criterion
The resolution criterion uses an X of 8 rolling counter with a default X value of 5. This means that 5
out of the last 8 atrial events must be slower than the programmed intervention rate for a return to the
programmed pacing mode.
PAGE 15
Page 24
Chapter 5 Programmable Parameters
Evia HF / HF-T Technical Manual
The higher the resolution criterion, the harder it is to end a Mode Switching event. Conversely, the
lower the value, the easier it is for Mode Switching to end.
Basic Rate during Mode Switching
This refers to the basic pacing rate while mode switching is active. The value selected is added to the
programmed basic rate value to become the basic rate during mode switch. By default this value is
+10 ppm. If the basic rate is programmed to 60 ppm, then the Basic Rate during mode switching would
be 70 ppm (60 ppm +10 ppm).
Rate Stabilization during Mode Switching
This feature is designed to minimize sudden rate changes in the ventricle that can occur with Ab and
intact conduction. To minimize the sudden rate changes, Evia CRT-P uses the Rate Fading concept.
The device determines a four-beat ventricular rate average and provides ventricular support pacing any
time the rate goes below the averaged rate minus 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 utter, there is a small chance that Mode Switch will not occur due
to atrial events falling within far-eld protection. As a result, inappropriate fast tracking up to the upper
tracking rate may occur. The 2:1 Lock-in protection feature is designed to promote Mode Switching and
prevent the patient discomfort that may be associated with an inappropriately tracked atrial tachycardia.
2:1 Lock-in Protection behavior is more likely to occur if the far-eld protection parameter is
programmed too long (greater than 150 ms). This potentially allows every other atrial event to occur in
the far-eld protection interval.
When Evia CRT-P senses eight consecutive atrial events in the far-eld protection window and the
ventricular paced response rate is greater than 100 bpm, the AV Delay is extended to a maximum value
of 300 ms (AV Delay + FFP interval to a max of 300 ms) for one event. If the event sensed in the FFP
window moves with the ventricular paced event during the extension of the AV Delay, it is a cross-talk
event due to ventricular pacing. However, if it does not move with the ventricular paced event when the
AV Delay is extended, it is a intrinsic atrial event (atrial utter event)
Additionally, during DDI(R), the AV-delay is set to 100 ms.
Mode Switch Events are recorded in memory and are available to the user through the following
diagnostics:
• IEGM Recordings Found in the Holter Tab
• Mode Switch Counter
• Total Mode Switch Duration
Mode Switching is available during magnet application after 10 cycles of ASYNC pacing and
during ERI.
5.1.5 Pacing Modes with Triggered Response
Pacing modes with triggered response correspond to their respective demand pacing modes, except
that a sensed event will not inhibit but will rather trigger a pacing pulse, simultaneously with the sensed
event, into the same chamber where sensing has occurred. The demand and corresponding triggered
pacing modes are:
Demand: DDD VVI AAI
Triggered: DDT VVT AAT
PAGE 16
Page 25
Chapter 5 Programmable Parameters
Evia HF / HF-T Technical Manual
The triggered pacing mode xes the AV delay to 180 ms and does not provide a safety AV delay.
Pacing modes with triggered response may be indicated in the presence of interference signals to
prevent inappropriate pulse inhibition. They may also have diagnostic application for ECG identication
of sense events as an alternative to marker signals. Triggered pacing may also be used for
hemodynamic as well as electrophysiologic studies and for termination of tachycardias by non-invasive
triggering of pulse generator pulses with chest wall stimuli generated by an external pulse generator.
CAUTION
Programmed to Triggered Modes When programmed to triggered
modes, pacing rates up to the programmed upper limit may occur in
the presence of either muscle or external interference.
Triggered Modes While the triggered modes (DDT, VVT, and AAT) can
be programmed permanently, the use of these modes is intended as
a temporary setting in situations where maintaining the programming
head in place would be impossible or impractical (i.e., during exercise
testing or extended Holter monitoring) or as a short term solution to
pulse generator inhibition by extracardiac interference. To avoid the
potential for early battery depletion, it is important that the triggered
modes are not used for long term therapy, and that the pulse generator
is returned to a non-triggered permanent program.
5.2 Rate Related Functions
The availability of parameters and parameter values is determined by the software used for
programming/ interrogating the pulse generator.
5.2.1 Basic Rate
The Basic rate parameter (Figure 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.
Programming conicts for Basic rate occur when Atrial and/or Ventricular Capture Control is
programmed ON. When capture control is programmed ON, the basic rate is limited to 100 bpm.
Figure 2: Basic Rate/Night Rate Screen with Default Settings
PAGE 17
Page 26
Chapter 5 Programmable Parameters
Evia HF / HF-T Technical Manual
CAUTION
Programming Modication 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.
5.2.2 Rate Hysteresis
Parameter Name Range Standard Value Unit
Rate Hysteresis OFF, -5...(-5)...-90 OFF bpm
Scan Hysteresis OFF, 1...(1)...15 OFF cycles
Repetitive Hysteresis OFF, 1...(1)...15 OFF cycles
Rate Hysteresis may be programmed to promote intrinsic conduction for patients who can tolerate
intrinsic activity below a programmed pacing or sensor-indicated rate. This hysteresis rate becomes
the lowest rate permitted before the device begins pacing. Rate hysteresis requires a sensed event
in order to activate. Rate hysteresis will remain active as long as the intrinsic activity remains above
the programmed hysteresis rate. When the intrinsic rate falls to the hysteresis rate, the device will
deliver one paced event at the hysteresis rate and then begin pacing at the programmed basic rate.
Pacing will remain at the basic/sensor rate until a new intrinsic event occurs. This new intrinsic event
reactivates rate hysteresis. An example is shown in Figure 3. Features such as scan and repetitive
hysteresis are available to promote intrinsic activity and are discussed in this chapter.
Figure 3: Example of Rate Hysteresis
Repetitive Rate Hysteresis and Scan Rate Hysteresis are Rate Hysteresis enhancements available in
the Evia CRT-P family. These features encourage a patient’s own rhythm, periodically allowing for, or
looking for, intrinsic activity.
NOTE:
If rate adaptation is active, the Hysteresis rate is based on the current sensor-indicated rate and the
value of the programmable parameter.
Hysteresis is not available in CLS or DVI, and DVIR modes.
PAGE 18
Page 27
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.
During night mode the rate will not fall below the programmed night rate even if Hysteresis can take
it to a lower rate. Programming conicts arise when the total decrease in rate is below 30 ppm. Care
should be exercised to avoid programming a Night Mode rate and hysteresis that is below what is
appropriate and may be tolerated by the individual patient.
5.2.3 Scan Hysteresis
Scan Rate Hysteresis seeks to encourage an intrinsic rhythm during long periods of pacing. The
algorithm is enabled after 180 consecutive paced events. Once the 180 paced events are met, the
device will pace at the hysteresis rate for the programmed number of events (1-15). If intrinsic activity
does not return during that period, pacing will continue at the programmed bradycardia rate or sensor
indicated rate, whichever is higher.
Scan Hysteresis programmed to 5 cycles
Scan Hysteresis programmed to 5 cycles
178
178
Bas ic rate
Bas ic rate
179
179
180
180
2
3
2
1
1
4
3
4
Scan Hysteresis programmed to 5 cycles
Scan Hysteresis programmed to 5 cycles
178
178
Bas ic rate
Bas ic rate
179
179
180
180
Hysteresis rate
Hysteresis rate
Paced event
Paced event
Hysteresis rate
Hysteresis rate
Paced event
Paced event
Sens ed event
Sens ed event
Figure 4: Scan Hysteresis
In the left portion of Figure 4, pacing occurs at the hysteresis rate for the programmed number of ve
cycles. With no return of intrinsic rhythm, the device resumes pacing at the basic rate. Once pacing
begins at the basic rate, the Scan Hysteresis count starts over. The right side of Figure 4 shows a
return of intrinsic activity after two paced events at the hysteresis rate. Once the intrinsic rate returns,
hysteresis is maintained.
Scan hysteresis has been incorporated to promote intrinsic cardiac rhythm and may reduce pulse
generator energy consumption.
NOTE:
Scan Hysteresis can be used during night mode, but it will not take the rate below the programmed
night rate.
Scan Hysteresis is only available when Hysteresis is selected on.
After the ASYNC effect following magnet application, hysteresis is available.
5.2.4 Repetitive Hysteresis
When Repetitive Rate Hysteresis is activated (after 180 consecutive sensed events), the feature allows
a programmed number of paced events (1-15) at the hysteresis rate to occur before returning to the
programmed basic/sensor rate. This is done to allow return of intrinsic activity in the hysteresis zone. If
intrinsic activity is sensed, pacing will be inhibited. If no intrinsic activity returns within the programmed
number of events, pacing will resume at the programmed basic rate or sensor rate.
PAGE 19
Page 28
Chapter 5 Programmable Parameters
Evia HF / HF-T Technical Manual
Scan Hysteresis programmed to 5 cycles
Scan Hysteresis programmed to 5 cycles
1
178
178
Bas ic rate
Bas ic rate
179
179
180
180
1
Scan Hysteresis programmed to 5 cycles
Scan Hysteresis programmed to 5 cycles
2
2
3
3
4
4
178
178
Bas ic rate
Bas ic rate
179
179
180
180
Hysteresis ra te
Hysteresis ra te
Paced event
Paced event
Hysteresis ra te
Hysteresis ra te
Paced event
Paced event
Sens ed event
Sens ed event
Figure 5: Repetitive Hysteresis
In the left portion of Figure 5, pacing occurs at the hysteresis rate for the programmed number of
ve cycles. Because there is no return of the intrinsic rhythm, the device restores pacing at the
programmed/sensor rate. The right side of Figure 5 shows a return of intrinsic activity after two paced
events at the hysteresis rate.
Once the intrinsic rhythm returns, the repetitive hysteresis count begins again. If the intrinsic rhythm
falls to the hysteresis rate before the 180 count has been met, the device uses the standard rate
hysteresis.
Repetitive hysteresis has been incorporated to promote spontaneous cardiac rhythm and may reduce
pulse generator energy consumption.
NOTE:
Repetitive Hysteresis can be used during night mode but it will not take the rate below the programmed
night rate.
Repetitive Hysteresis is only available when Hysteresis is selected on.
There is one Standard Hysteresis interval which occurs before the programmable number of Repetitive
Hysteresis occur.
5.2.5 Night Mode
Night rate is designed to reduce the pacing rate to emulate the decreased metabolic needs during
sleep. When Night Rate is active, the pacing rate automatically decreases during the programmed
hours. The Night Rate is programmable from 30 to 200 bpm or OFF.
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” of 15 bpm for AV modulation during capture testing. These
conicts will appear in blue, as seen in Figure 6.
PAGE 20
Page 29
Chapter 5 Programmable Parameters
Evia HF / HF-T Technical Manual
Figure 6: Night Rate Screen
When Night rate is active, the Basic rate is reduced to the Night rate using the Sensor rate Decrease
value programmed in the device, even when the sensor is OFF. When Night rate ends, Evia CRT-P
uses the Sensor rate Increase value to return to the basic rate.
If the sensor is programmed OFF, the device will use the default sensor rate increase/decrease values.
The use of sensor increase/decrease values prevents sudden rate changes that may be felt by the
patient.
During Night rate, the accelerometer remains active, and the patient will continue to receive the benet
of sensor-driven pacing.
Night rate is NOT available when CLS is active as CLS determines rate requirements for the patient.
One may consider reducing the basic rate of the device to optimize the intrinsic rhythm.
Caution should be used in patients who travel across time zones as Night rate is clock-based. Night
rate start and stops times are programmable in 10 minute increments.
The blue conicts show permanent programming conicts when ventricular capture control (VCC) is
programmed ON. These conicts 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 conicts seen in Figure 6 show that Night Rate cannot be programmed greater than the basic
rate value. The value OFF will always correspond to the programmed basic rate of the device.
NOTE:
When Night rate and Rate Hysteresis are programmed, the lowest pacing rate possible is the
programmed Night rate. Evia CRT-P does not allow programming less than 30 bpm.
NOTE:
When Night Mode and Ventricular Capture Control are programmed ON simultaneously in VVI(R),
VCC will not take the rate below the programmed night rate
Over time, the pulse generator’s internal time-of-day clock will exhibit a discrepancy with the actual
time (less than 1 hour per year). This will cause a corresponding discrepancy between the programmed
bed and wake times and the actual times that the system changes the rate.
PAGE 21
Page 30
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.
5.2.6 Rate Fading
Rate Fading is intended to prevent a sudden drop in heart rate when the pulse generator transitions
from tracking an intrinsic rhythm to pacing due to an abrupt decrease in the intrinsic rate, in order to
prevent potential reactions such as dizziness, light headedness, lack of energy and fainting.
With Rate Fading enabled, the pulse generator calculates the Fading Rate, which is a four beat
average of the intrinsic rate reduced by 10 ppm. When the intrinsic rate drops considerably (below the
Fading Rate), the pacing rate begins at the RF rate and then decreases gradually by the programmable
Decay Rate to the Sensor Indicated Rate or Basic Rate.
NOTE:
The Fading Rate cannot exceed the programmed Maximum Activity Rate and cannot increase faster
than the RF Rate decrease (programmable in ppm/cycle).
Figure 7: Rate Fading
The Rate Fading feature is available after 10 ASYNC while in magnet mode and disabled at ERI and in
backup mode.
5.3 Pulse Specic Features
Features related to the pacing pulse.
5.3.1 Pulse Amplitude
The pulse amplitude can be programmed as shown in Table 3.
Chamber Range Default
Atrium
Right/Left
Ventricle
Table 3: Pulse Amplitude Parameters
0.2...(0.1)...3.0...
(.1)...6.0...(0.5)...7.5 V
0.2...(0.1)...3.0...
(.1)...6.0...(0.5)...7.5 V
3.0 V
3.0 V
PAGE 22
Page 31
Chapter 5 Programmable Parameters
Evia HF / HF-T Technical Manual
Pacing outputs can be programmed in each chamber from 0.2 V to 7.5 V if Capture Control is inactive.
Caution should be used when programming high outputs for an extended period of time, as this can
result in reduced longevity.
Programming the pacing output in the atrial or ventricular channel is not possible when Atrial and
Ventricular Capture Control is ON as the programmed output is determined by the device.
NOTE:
When VCC is programmed to ATM, the pulse amplitude cannot be programmed by the user to a value
higher than the programmed Maximum VCC Amplitude (Max. Ampl.). When VCC is programmed
to ON, the pulse amplitude will be set by the device to the threshold plus the programmed Safety
Margin, but never lower than the Minimum VCC Amplitude (xed at 0.7 V.)
CAUTION
Pulse Amplitude Programming of pulse amplitudes, higher than
4.8 V, in combination with long pulse widths and/or high pacing rates
can lead to premature activation of the replacement indicator. If a pulse
amplitude of 7.0 V or higher is programmed and high pacing rates are
reached, output amplitudes may differ from programmed values.
Programming Modications 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.
5.3.2 Pulse Width
The pulse width can be programmed as shown in Table 4.
Chamber Range Default
Atrium
Right/Left
Ventricle
The selected pulse width determines the duration for which the programmed pulse amplitude will be
applied to the heart. The pulse width is independently programmable (0.1 to 1.5 ms) for the atrial and
ventricular channels. 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. Pulse
widths may be extended, allowing reduction of Pulse amplitude to prevent diaphragmatic stimulation in
patients. When capture control is programmed ON, pulse width programming cannot exceed 0.4 ms,
as shown by the conicts in Figure 8.
0.1, 0.2, 0.3, 0.4, 0.5,
0.75, 1.0, 1.25, 1.5 ms
0.1, 0.2, 0.3, 0.4, 0.5,
0.75, 1.0, 1.25, 1.5 ms
Table 4: Pulse Width Parameters
0.4 ms
0.4 ms
If a threshold test was performed, the capture threshold value obtained is displayed at the bottom of the
Pulse width screen to help guide output programming.
PAGE 23
Page 32
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)
Chamber Range Default
Atrium
Right Ventricle
Left Ventricle
Auto, 0.1...(0.l)...1.5...
(0.5)...7.5 mV
Auto, 0.5...(0.5)...
7.5 mV
OFF, Auto, 0.5...
(0.5)...7.5 mV
Auto
Auto
Auto
The parameter “sensitivity” is used to set the pulse generator’s threshold for detecting intracardiac
signals. The lower the programmed sensitivity value, the higher the device’s sensitivity.
If intracardiac signals are of low amplitude, a change to a higher sensitivity (lower value) may be
necessary. Conversely, if the sensing amplier is responding to extraneous signals, such as artifact
or interference, a change to a lower sensitivity (higher value) may resolve the difculty. In dualchamber sensing modes, the sensitivity values for the atrial and ventricular channels are independently
programmable.
With unipolar sensing, the lowest sensitivity setting is 0.5 mV in the atrium. Blue conict icons for the
atrial channel shown in Figure 9 show a conict message, requiring the user to program the lead to a
bipolar conguration before the value can be permanently programmed.
A conict will appear when attempting to program 0.5 mV in the ventricle, as shown in Figure 9, with
unipolar sensing. The user is asked to extend the Ventricular Blanking after Ap to resolve the conict.
This is done to reduce the potential of oversensing the atrial pacing spike with unipolar sensing. Once
resolved, the user can program 0.5 mV sensitivity in the ventricle.
If a sensing test has been performed, the sensing value is displayed at the bottom of the sensitivity
parameter to guide sensing programming of the device.
PAGE 24
Page 33
Chapter 5 Programmable Parameters
+/- Minim um
Threshold
Detection Hold-off Period (DHP)
Step
Duration
+/- Sensitivity Threshold
from the previous event
½ Peak
1/4 Peak
+/- Sensitivity Threshold
of the current event
Event
Detection
Atrium
Post Sense
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. After this initial stage, the
sensitivity is initially reduced to 50% of the measured peak of the amplitude. At the end of the phase
duration, sensitivity is reduced to 25% of the measured peak of the amplitude and maintained until
detection of the next event. The sensitivity can never go below the minimum threshold shown below
in the sensed event summary.
Atrial and ventricular ASC function for sensed events are the same, except that the Detection Hold-off
and Step Duration periods use different values. This is shown in Figure 10.
Sensed Events Summary
Atrium
Right/Left Ventricle
Detection
Hold-off
101 ms 82 ms 0.2 mV
121 ms 125 ms 2.0 mV
Step
Duration
DHP 100 ms
Step Duration 82 ms
Ventric le
DHP 121 ms
Step Duration 125 ms
Minimum
Threshold
1
1 If the sensing is programmed unipolar, the minimum threshold will be 0.5 mV
Figure 10: Automatic Sensitivity Control for Sensed Events
PAGE 25
Page 34
Chapter 5 Programmable Parameters
+/- Minim um
2.0 mV
Detection Hold-off Period (DHP)
2x Step
Duration
+/- Sensitivity Threshold
from the previous event
+/- Sensitivity Threshold
of the current event
Event
Ventric le
Post Pace Event -
Fixed value
Ventricle – 2.5 mV
+/-
Threshold
Detection Hold-off Period
2x Step
Duratio
+/- Sens itivity
Threshold
Event
Pace
Atrium
Step Duration 82 ms
Post Pace Event – Atrium -
Fixed value
Atrium – 1.0
Step
Duratio
Step
Duratio
½
Value
1/4
Value
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.
Atrial and ventricular post-pace sensing function the same except for the Detection Hold-off and Step
Duration. The atrial channel provides an additional step if the sensitivity is programmed to 0.2 mV as is
shown in Figure 11.
Detection
Hold-off
Step Duration Total
Minimum
Threshold
Atrium 120 ms 164 ms (2 x 82 ms) 0.2 mV
Right/Left Ventricle 200 ms 250 ms (2 x 125 ms) 2.0 mV
DHP 200 ms
Step Duration 125 ms
Detection
Pace event
Figure 11: Automatic Sensitivity Control for Ventricular Paced Events
Threshold
2
2 If the sensing is programmed unipolar, the minimum threshold will be 0.5 mV
PAGE 26
DHP 120 ms
Fixed
Fixed
Detection
Minim um
Figure 12: Automatic Sensitivity Control for Atrial Bipolar Paced Events
Page 35
+/-
Threshold
Detection Hold-off Period
2x Step
Duratio
+/- Sens itivity
Threshold
Event
Atrium
Step Duration 82 ms
Post Pace Event – Atrium -
Fixed value
Atrium – 1.0
½
Fixed
Chapter 5 Programmable Parameters
Evia HF / HF-T Technical Manual
DHP 120 ms
Detection
Pace
Minim um
Figure 13: Automatic Sensitivity Control for Atrial Unipolar Paced Events
Ventricular Pacing Overview
Table 5 shows a ventricular pacing overview and applies to bradycardia programming and Mode Switch
programming.
Parameter Range Default
Ventricular pacing BiV, RV BiV
Triggering OFF, RVs, RVs+PVC RVs
LV T-wave protection ON, OFF ON
Maximum trigger rate Auto, 90...(10)...160 ppm Auto
Initially paced
chamber
VV Delay after Vp 0...(5)...100 ms 0 ms
VV Delay after Vs 0 ms 0 ms
LV, RV LV
Table 5: Ventricular Pacing Parameters
Figure 14: Ventricular Pacing Parameter Screen
PAGE 27
Page 36
Chapter 5 Programmable Parameters
Evia HF / HF-T Technical Manual
5.4.1 Ventricular Pacing Parameter Options
Ventricular Pacing
BiV, RV
Ventricular pacing allows the user to program BiV or RV only pacing, depending on the patient
condition. The choice of BiV pacing in this screen applies only to pacing in the permanent pacing
mode. Pacing choices for Mode Switch are found in those respective feature areas.
Triggering
OFF, RVs, RVs + PVC
This feature permits triggered pacing when RV sensed events occur, as long as the RV sensed rate
does not exceed the Maximum Triggered Rate. When set to the default of AUTO, the trigger rate
will be equal to the Upper Tracking Rate +20 bpm. When programmed to RVs and PVC, the device
triggers on RVs event, as well as extra systoles (PVC or VES), as long as the rate does not violate the
Maximum Trigger Rate.
LV T-wave Protection
ON or OFF
If LV T-wave protection has been activated, Evia HF / HF-T will detect LVs events and start a left
ventricular maximum trigger interval (equal to the upper tracking Interval in ms when programmed to
Auto). This feature prevents the delivery of a LV paced event whenever a LV sensed event occurs
rst. It is also designed to prevent pacing into the sensed refractory period and potentially triggering a
tachyarrhythmia. When LV T-wave protection is programmed ON, the device will provide LVs statistics
and accurate LVp percentages. If LV T-wave protection is off, LVs data is not collected by the device.
Maximum Trigger Rate
Auto, 90 … (10) … 160 ppm
This feature sets the maximum triggered pacing rate to a programmed value, including values above
the UTR. The Auto setting is equivalent to the programmed Upper Tracking Rate (UTR) and will
automatically change the trigger rate to match changes in UTR programming. Trigger rate pacing
applies to permanent pacing and Mode Switch.
Initially paced chamber
LV, RV
Allows the user to program which chamber paces rst.
V-V delay after Vp (ms)
0...(5)...100 ms
This parameter allows the user to program the interval between paced events.
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
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.
If the pulse generator is programmed to dual chamber sensing, the refractory periods are independently
programmable for each sensing channel. There are two refractory periods in the atrium:
• Regular atrial refractory period, which is automatically adjusted by the Auto Aref functionality
• PVARP is started with each ventricular pace outside of the AV delay. In DDI mode, PVARP is also
started with a regular ventricular sense or
• PVARP after PVC is started after a premature ventricular sensed event (PVC)
CAUTION
Short Pacing Intervals Use of short pacing intervals (high pacing
rates) with long atrial and/or ventricular refractory periods may
result in intermittent asynchronous pacing and, therefore, may be
contraindicated in some patients.
5.5.2 Atrial Refractory Period
The atrial refractory period is set by default to Auto. This means the atrial refractory period is equal
to 225 ms, which is automatically extended if the AV Delay is programmed longer than 225 ms to the
programmed AV Delay value.
5.5.3 PVARP
The Post Ventricular Atrial Refractory Period (PVARP) is a function in the pacemaker to help prevent
Pacemaker Mediated Tachycardia (PMT), by preventing false classication of a retrograde conduction
as an atrial event.
There are 2 different behavior modes of PVARP based on programmed mode, which is
described below.
• In P-synchronous modes(e.g. DDD), the PVARP timer is started after : Vp, Vp(WKB),
Vp(SW), Vp(BU)
• In R-synchronous modes (e.g. DDI), the PVARP timer is started after: Vp, PVC, VS.
• After a VES, the parameter PVARP after PVC is automatically extended to PVARP + 150ms, up to
a maximum of the user programmable “PMT VA Criterion limit” + 50 ms. This parameter was
formerly known as PMT protection after PVC.
This behavior is shown in Figure 15.
PAGE 29
Page 38
Chapter 5 Programmable Parameters
Evia HF / HF-T Technical Manual
Figure 15: PVARP Timing
Table 6 shows the PVARP parameter values and ranges.
Parameter
Name
PVARP AUTO, 175..(5)..600 250 ms ms
PVARP
after PVC
Table 6: PVARP Parameter Values and Ranges
PVARP + 150 ms to a
maximum of 600 ms
Range
Standard
Value
400 ms ms
Units
5.5.3.1 AUTO PVARP
If the PVARP feature is set to AUTO, the algorithm optimizes the PVARP to reduce the incidence of
PMT. The nominal values of PVARP value is set to 250 ms, and PVARP after PVC is set to 400 ms.
Once a PMT is detected, the algorithm automatically extends the PVARP and PVARP after PVC by 50
ms, up to the maximum value of 600 ms.
If there is no PMT detected by the algorithm, both the PVARP and PVARP after PVC is reduced by 50
ms every 7 days, but no less than the minimum value of 175 ms.
5.5.3.2 Right Ventricular Refractory Period
200...(25)...500 ms
The right ventricular refractory period is designed to prevent T-wave oversensing, which could result
in resetting the Lower Rate timer and causing lower than intended pacing rates. T-wave oversensing
could affect pacing rates, as well as statistics. However, caution should be used in programming the
right ventricular refractory period too long, as misclassication of appropriate events could result. The
right ventricular refractory period is applied to all ventricular events (Vs, Vp and PVC).
5.5.3.3 Left Ventricular Refractory Period
The left ventricular refractory is set to a xed value of 200 ms. It should be noted that left ventricular
events do not contribute to overall pacemaker timing function.
PAGE 30
Page 39
5.5.4 AV Delay
Chapter 5 Programmable Parameters
Evia HF / HF-T Technical Manual
Maximum AV Delay Programmable Value 350 ms
Maximum AV Delay Programmable Value
with AV Hysteresis
I-Opt AV Delay maximum
3
450 ms
400 ms
Lower Rate AV Delay Upper Rate AV Delay
Low 150 ms 120 ms
Medium 150 ms 75 ms
High 150 ms 50 ms
Fixed 150 ms 150 ms
Individual User Dened User Dened
AV Delay Settings (Default for BiV programming)
Evia CRT-P provides three preset AV Delay settings: Low, Medium and High. In addition, the user
can program a xed AV Delay, as well as a user-dened program (Individual). Similar to previous
generations of devices, Evia CRT-P allows the user to program individual AV Delay programs. Evia
CRT-P adds the option of changing the values on the AV Delay visual display in addition to changing
the numeric parameter buttons. By placing the pen over the “o” on the display, the user can slide the
value up or down to increase or decrease the AV Delay setting for a particular rate bin.
4
5.5.4.1 Dynamic AV Delay
The AV delay denes the interval between an atrial paced or sensed event and the ventricular pacing
pulse. If the pulse generator is programmed to a dual chamber sensing mode, an intrinsic ventricular
event falling within the AV delay will inhibit the ventricular pacing pulse. If not contraindicated, a longer
AV delay can be selected to increase the probability of ventricular output pulse inhibition. Short AV
delays are available for testing purposes or if ventricular pre-excitation is desired (i.e., hemodynamic
considerations).
Dynamic AV Delay provides independent selection of AV Delays from ve rate ranges at pre-set AV
Delay values. In addition, the AV Delay after atrial pace events can be differentiated from the AV interval
after atrial sense events for dual chamber pacing modes. Dynamic AV Delay is programmable within
the following atrial rate ranges at the values specied in Table 7.
3 I-Opt available in the Evia HF-T if RV only pacing if programmed
4 Conict with Sense compensation will arise as a minimum of 15 ms AV Delay is required
PAGE 31
Page 40
Chapter 5 Programmable Parameters
Evia HF / HF-T Technical Manual
Rate Ranges LOW
below 70 bpm
70—90 bpm
91—110 bpm
111—130 bpm
above 130 bpm
Table 7: Dynamic AV Delay Settings
150 ms
140 ms
130 ms
120 ms
120 ms
In addition the Dynamic AV Delays may be programmed individually for each rate range or a xed AV
delay may be programmed for all ranges.
The AV Delay feature includes an AV shortening option (sensed compensation) for dual chamber
pacing modes. The sense compensation can be programmed to OFF and –10 … (-5) … -120 ms.
When selected, the AV delay after an atrial sense event is the AV delay after an atrial pace minus the
sense compensation.
The Dynamic AV Delay is intended to mimic the physiologic, catecholamine-induced shortening of the
AV Delay with increasing rate.
5.5.4.2 AV Hysteresis
OFF, Low, Medium, High, Negative and I-OPT
I-Opt not available if BiV pacing programmed
Low: Hysteresis - 70 ms longer than programmed AV Delay
Medium: Hysteresis – 110 ms longer than programmed AV Delay
High: Hysteresis – 150 ms longer than programmed AV Delay
Repetitive - OFF, 1 … (1) … 10
Scan - OFF, 1 … (1) … 10
Negative: Hysteresis – 2/3 of the programmed AV Delay value
Repetitive – OFF, 1 … (1) … 15 … (5) …100 … (10) …180
AV Hysteresis mode choices of Low, Medium and High are designed to promote intrinsic activity by
periodically extending the AV interval to look for intrinsic activity. If intrinsic activity is present, the AV
Delay maintains the hysteresis value to allow intrinsic R-waves to conduct. The maximum length the
AV Delay can be extended is 450 ms. This will be automatically shortened as the rate increases to
ensure appropriate AV conduction. Table 8 shows the hysteresis value for each AV Delay setting.
PAGE 32
Page 41
Chapter 5 Programmable Parameters
Evia HF / HF-T Technical Manual
AV Setting Low 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 170 ms 210 ms 250 ms
120 ms 190 ms 230 ms 270 ms
130 ms 200 ms 240 ms 280 ms
140 ms 210 ms 250 ms 290 ms
150 ms 220 ms 260 ms 300 ms
160 ms 230 ms 270 ms 310 ms
170 ms 240 ms 280 ms 320 ms
180 ms 250 ms 290 ms 330 ms
190 ms 260 ms 300 ms 340 ms
200 ms 270 ms 310 ms 350 ms
225 ms 295 ms 335 ms 370 ms
250 ms 320 ms 360 ms 400 ms
300 ms 370 ms 410 ms 450 ms
350 ms 420 ms 450 ms 450 ms
Table 8: AV Hysteresis Settings
5.5.4.3 AV Repetitive Hysteresis
With AV Repetitive Hysteresis, the AV delay is extended by a dened hysteresis value after sensing
an intrinsic ventricular event. When a ventricular stimulated event occurs, a long AV delay is used for
the programmed number of cycles. (1 … 10). If an intrinsic rhythm occurs during one of the repetitive
cycles, the long duration AV delay interval remains in effect. If an intrinsic rhythm does not occur during
the repetitive cycles, the original AV delay interval resumes.
Figure 16: AV Repetitive Hysteresis
PAGE 33
Page 42
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. If an intrinsic rhythm is not detected within the number
of scan cycles, the original AV delay value resumes.
Figure 17: AV Scan Hysteresis
5.5.4.5 Negative AV Delay Hysteresis
With Negative AV Delay Hysteresis, the AV delay is decreased by a dened value after a ventricular event
is sensed, thereby promoting ventricular pacing. The Negative AV Delay Hysteresis value corresponds to
the programmed AV delay, multiplied by approximately 2/3, limited to a minimum of 15 ms.
The normal AV delay resumes after the programmed number of consecutive ventricular paced events
(Repetitive Negative AV Delay Hysteresis) elapses.
Figure 18: Negative Hysteresis
CAUTION
Negative AV Delay Hysteresis This feature insures ventricular
pacing, a technique which has been used in patients with hypertrophic
obstructive cardiomyopathy (HOCM) with normal AV conduction in order
to replace intrinsic ventricular activation. No clinical study was conducted
to evaluate this feature, and there is conicting evidence regarding
the potential benet of ventricular pacing therapy for HOCM patients.
In addition, there is evidence with other patient groups to suggest that
inhibiting the intrinsic ventricular activation sequence by right ventricular
pacing may impair hemodynamic function and/or survival.
PAGE 34
Page 43
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
increases, I-Opt will eventually shorten to ensure appropriate conduction is maintained, as shown in
Figure 19. A combination of high rate and I-Opt can result in a situation where 2:1 block occurs during
repetitive hysteresis function.
The Scan and Repetitive Hysteresis values are set to 5 and function as previously described.
Figure 19: I-Opt
Subsequent to switching I-Opt on, the range of values is pre-congured as follows:
Function I-Opt Standard Program
AV Hysteresis 400 ms OFF
AV Scan Hysteresis 5
Repetitive AV Hysteresis 5
Table 9: I-Opt Parameters
NOTE:
Activate PMT Protection to prevent pacemaker mediated tachycardia.
I-Opt not available is BiV pacing is programmed.
5.5.4.7 EasyAV
EasyAV is a feature designed to help guide AV delay and Sense compensation programming by
collecting data regarding the intervals between an atrial paced or sensed event and subsequent
ventricular sensed events (i.e. Ax-Vs intervals). The EasyAV algorithm is then capable of overlapping
PAGE 35
Page 44
Chapter 5 Programmable Parameters
Evia HF / HF-T Technical Manual
the Ax-Vs interval distributions over the Dynamic AV delay screen as a way of guiding AV delay and AV
Hysteresis delay programming. EasyAV neither modies the programmed AV delay settings nor does it
make suggestions to the user.
Evia HF / HF-T provides statistical information about the As-Vs and Ap-Vs interval distribution, which
has been recorded in between in-house follow-ups for each patient. These statistics provide the range
as well as the median value of recorded As-Vs and Ap-Vs intervals for each of the rate marks 60, 80,
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
recorded statistical information about the As-Vs and Ap-Vs interval distribution within the user interface
for programming the AV delay settings (see Figure 20). The recorded As-Vs and Ap-Vs interval
distribution is displayed separately to program the AV delay settings after As or Ap. In case no As-Vs
and Ap-Vs interval distributions are available, the user is informed that EasyAV is not available.
Figure 20: EasyAV
EasyAV allows the user to select AV delay settings based on the patient specic intrinsic conduction
without navigating to the diagnostic pages of the programmer. With respect to Evia HF / HF-T, the
user can ensure short enough AV delay settings to allow for the highest possible biventricular pacing
percentage.
5.5.5 Ventricular Blanking After Ap
The ventricular blanking after Ap (atrial pace) is the period after an atrial pacing pulse during which
ventricular sensing is deactivated. It is intended to prevent ventricular sensing of the atrial pacing pulse
(“crosstalk”). This parameter is programmable from 30 to 70 ms.
PAGE 36
Page 45
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.
5.5.6 Far-Field Protection
Far-eld Protection after Vs - 100...(10)...220 ms; default 100 ms
Far-eld Protection after Vp - 100...(10)...220 ms; default 150 ms
Inappropriate mode switches may occur in the presence of atrial oversensing of ventricular events. This
scenario is seen when mode switches are recorded in the diagnostics of the pacemaker in the absence
of true documented atrial arrhythmias. To aid in diagnosis, a recorded IEGM will demonstrate a
rhythmic pattern of a sensed atrial event followed by an atrial refractory event (ARS) at or just following
the ventricular event. This may occur with both sensed and paced ventricular events.
The Far-Field Protection in the atrial channel feature affects both sensed and paced events originating
from the ventricle and sensed on the atrial channel. The programming resolution for Far-Field
Protection is 100 ms to 220 ms following a Vs event, and 100 ms to 220 ms following a Vp event. The
shortest Far-Field Blanking period that will cover the atrial refractory sensed events is recommended to
prevent undersensing of true atrial events. Events sensed within this timer are annotated as Ars (FFP)
events and are not counted toward Mode Switching.
5.5.7 Safety AV Delay
The safety AV delay (set at 100 ms) applies to the pacing modes DDD-CLS, DDD(R), DVI(R), DDI(R),
and DDD(R)-ADI(R).
To prevent ventricular pulse inhibition in the presence of crosstalk, a ventricular pulse will be emitted
at the end of the safety AV delay (Figure 21). When pacing is AV sequential at the pre-set safety AV
delay, the presence of crosstalk should be considered and appropriate reprogramming performed
(lengthen the ventricular blanking time, lower ventricular sensitivity, bipolar conguration, and/or
lower atrial pulse energy).
Figure 21: Ventricular Blanking Time and Safety AV Delay (Dual Chamber)
PAGE 37
Page 46
Chapter 5 Programmable Parameters
WRL
1:1
2:1
60 ppm
130 ppm
150 ppm 400 ms
462 ms
1000 ms
AVD + PVAR P
Upper Tr acking R ate
Bas ic Rate
WRL
1:1
2:1
60 ppm
130 ppm
150 ppm 400 ms
462 ms
1000 ms
AVD + PVAR P
Upper Tr acking R ate
Bas ic Rate
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.
When the atrial rate surpasses the UTR, one of two different responses may occur, depending on the
programmed PVARP value and the AV Delay. Both responses — 2:1 block and Wenckebach — prevent
the device from pacing faster than the UTR.
In the Wenckebach zone, ventricular pacing is maintained at UTR as the atrial rate exceeds UTR.
Ventricular pacing continues at UTR until the atrial interval falls within PVARP+AV Delay (i.e., until a
block mode emerges) or until Mode Switching occurs.
In a 2:1 block zone, the ventricular pacing rate is half the intrinsic atrial rate. The 2:1 ratio between the
atrial and ventricular rate is maintained until the atrial rate reaches the Mode Switch Intervention Rate. At
a rate greater than this limit, ventricular pacing occurs in a non-tracking mode at the basic (sensor) rate.
5.6 Lead Polarity
Chamber
Sensed
Atrium Unipolar, Bipolar Unipolar
Right/Left
Ventricle
Chamber
Paced
Atrium Unipolar, Bipolar Unipolar
Ventricle
Left Ventricle
Figure 22: Upper Rate Behavior Example
Range Default
Unipolar, Bipolar Unipolar
Range Default
Right
Unipolar, Bipolar Unipolar
Unipolar Itip to case),
Unipolar (ring to case),
LV tip to LV ring,
LV tip to RV ring,
LV ring to LV tip,
LV ring to RV ring
Unipolar
(tip to case)
PAGE 38
Page 47
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 conguration. Lead polarity can be programmed separately for sensing and pacing in both
chambers.
If a bipolar lead is connected to the pulse generator, unipolar or bipolar conguration can be
programmed for pacing and sensing. As compared to bipolar pacing, the unipolar pacing pulse has
the advantage of being clearly identiable on the ECG. Unipolar pacing occasionally results in muscle
stimulation in the pulse generator pocket or diaphragm.
Bipolar sensing offers an improved “signal-to-noise” ratio due to the decreased susceptibility to
interference signals like skeletal myopotentials or EMI, and, therefore, permits programming of higher
sensitivities (lower values).
WARNING
Unipolar/Bipolar All Evia CRT-P models can be used with either
unipolar or bipolar IS-1 leads.
5.7 Parameters for Rate-Adaptive Pacing
The Evia CRT-P achieves rate adaption through programming of either standard motion-based pacing
via a capacitive accelerometer or by the means of the principle of closed loop stimulation (CLS) which
involves the translation of myocardial contractility into patient-specic pacing rates.
For standard motion-based rate adaption, the pulse generator is equipped with an accelerometer
located on the hybrid circuit of the pulse generator. This sensor produces an electric signal during
physical activity of the patient. If a rate-adaptive mode is programmed, then the sensor signal controls
PAGE 39
Page 48
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.
When in CLS mode, the pulse generator monitors and processes the intracardiac impedance signal
associated with myocardial contraction dynamics. Changes in the waveform of this impedance signal
are associated with changes in the contraction dynamics of the patient’s heart due to the heart’s
inotropic response to exercise. By monitoring these changes, the pulse generator can provide a pacing
rate that is appropriate and specic to the patient’s physiologic demands.
For a complete list of rate-adaptive pacing modes available in the Evia CRT-P, see Section 13.1.
The following functions are available for tailoring the motion based rate adaptation to the individual
patient except for the maximum closed loop rate, which is relevant to CLS.
Table 10 shows a summary of the parameters associated with rate adaptive pacing.
Parameter Name Range
Maximum Activity
(Sensor) Rate
Sensor Gain
Automatic Gain OFF, ON OFF none
Sensor Threshold
Rate Fading OFF, ON OFF none
Rate Increase 1...(1)...10 4 bpm/cycle
Rate Decrease 0.1, 0.2, 0.5, 1.0 0.5 bpm/cycle
5.7.1 Sensor Gain
Standard
Values
80...(5)...180 120 bpm
1.0, 1.1, 1.3, 1.4, 1.6, 1.8,
2, 2.3, 2.6, 3.0, 3.3, 3.7,
4, 4.5, 5, 6, 7, 8, 8.5, 10,
11, 13, 14, 16, 18, 20, 23
very low, low, medium,
high, very high
Table 10: Rate Adaptive Pacing Parameters
4 none
medium none
Unit
Figure 24: Gain Setting Choices
The sensor gain denes the slope of the linear function between exertion and pacing rate. It designates
a factor by which the electric signal of the sensor is amplied prior to the signal processing stages.
The programmable amplication permits adaptation of the individually programmed sensor gain to the
desired rate response. The optimum setting is achieved when the desired maximum pacing rate during
PAGE 40
Page 49
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.
If the sensor-driven rate is not sufcient at high levels of exertion the sensor gain setting should
be increased. The sensor gain should be reduced if high pacing rates are obtained at low levels
of exertion. Refer to the sensor statistics or perform a sensor optimization if the rate response is
suspected in being inadequate for the patient.
Figure 25: Inuence of Sensor Gain on the Rate Response
5.7.2 Automatic Sensor Gain
Evia CRT-Ps offer an Automatic Sensor Gain setting, which allows the physician to have the Sensor
Gain parameter adjusted automatically.
Figure 26: Automatic Gain Programming
When the Automatic Sensor Gain is activated, the pulse generator samples the sensor-indicated rate.
The sensor gain will be increased by 10%, if the activity rate does not reach or exceed the programmed
activity rate (xed to 90% of maximum sensor rate) for 30 minutes each day over 7 consecutive days.
An increase in gain cannot occur more often than every 7 days. If, during the 24 hour period beginning
at midnight, the activity rate reaches or exceeds the programmed activity rate (90% of maximum sensor
rate) for one hour, the sensor gain setting is reduced by 10%. A change in the sensor gain only occurs
at midnight.
NOTE:
If the reed switch is closed, the accumulated time at maximum sensor rate is reset to zero, and the
sensor indicated rate measurement resumes for the period that remains in that day.
The Automatic Sensor Gain function is primarily inuenced by the Maximum Sensor Rate setting.
Therefore the Maximum Sensor Rate must be appropriately selected.
PAGE 41
Page 50
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). The
programmable sensor threshold ensures that a stable rate at rest can be achieved by ignoring sensor
signals of low amplitude that are not related to exertion.
If the pacing rate at rest is unstable, or tends to stay above the lower rate without activity, the sensor
threshold should be increased. The sensor threshold should be reduced if a sufcient rate increase is
not observed at a given level of exertion.
Figure 28: Effect of Sensor Threshold
5.7.4 Rate Increase
The rate increase parameter determines the maximum rate of change in the pacing rate if the sensor
signal indicates increasing exertion (Table 11). In DDDR, VDDR, DOOR, VVIR, VOOR, AAIR and
AOOR, a rate increase setting of 2 ppm per second increase in pacing rate would take 45 seconds to
change from a pacing rate of 60 ppm to 150 ppm.
PAGE 42
Page 51
Chapter 5 Programmable Parameters
Evia HF / HF-T Technical Manual
Increase in
Rate (ppm/s)
1 90
2 45
4 23
10 9
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.
Time to Increase
Rate (seconds)
5.7.5 Maximum Sensor Rate
Figure 29: Gain Setting Choices
Regardless of the sensor signal strength, the pacing rate during sensor-driven operation will never
exceed the programmed maximum sensor rate. The maximum sensor rate only limits the pacing
rate during sensor-driven operation and is independent of the rate limit. The maximum sensor rate
(programmable up to 180 ppm) must be less than or equal to the programmed UTR.
NOTE:
In the DDIR and DVIR modes, the sensor rates control the ventricular pacing rates independent of
the AV Delay.
5.7.6 Maximum Closed Loop Rate
With the Evia CRT-P programmed to CLS rate adaptation, the pacing rate during CLS-driven operation
will never exceed the programmed maximum closed loop rate. The maximum closed loop rate only
limits the pacing rate during sensor-driven operation and is independent of the rate limit. The maximum
closed loop (programmable up to 160 ppm) must be less than or equal to the programmed UTR.
CAUTION
Programming Modications 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 43
Page 52
Chapter 5 Programmable Parameters
Evia HF / HF-T Technical Manual
5.7.7 Rate Decrease
The rate decrease parameter determines the maximum rate of change in the pacing rate, if the sensor
signal indicates decreasing exertion. In DDDR, VDDR, DOOR, VVIR, VOOR, AAIR, and AOOR, the
rate decrease setting of 0.5 ppm per second decrease in pacing rate would take 180 seconds to
change from 150 ppm to 60 ppm.
Decrease in
Rate (ppm/s)
0.1 900
0.2 450
0.5 180
1.0 90
Table 12: Rate Decrease
The programmed rate decrease setting applies only to the decrease in pacing rate during sensor-driven
operation in the primary chamber being paced.
Time to Decrease
Rate (seconds)
5.8 Management of Specic 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-eld
protection intervals are programmed such that every second intrinsic atrial event falls within the
blanking period and the pulse generator detects an atrial rate that is half of the actual rate, the pulse
generator does not Mode Switch during an atrial tachycardia as programmed. With 2:1 Lock-In
Management, the tachycardia is detected and conrmed, thereby triggering a Mode Switch.
The 2:1 Lock-In Management feature consists of suspicion, conrmation and termination phases, which
are described below:
Suspicion
The pulse generator suspects 2:1 Lock-In when the following criteria are met:
• 8 successive V-pace—A-sense (VpAs) sequences have occurred with an average length shorter
than the 2:1 Lock-In VA Length Criterion. This VA Length Criterion is based on the AV delay (AsVp)
and far-field protection intervals (FFB).
• The mean deviation of these 8 VpAs intervals is less than the 2:1 Lock-In Stability Criterion,
defined as 50ms.
Conrmation
When the suspicion criteria have been met, the AV delay is increased by the programmed far-eld
protection interval (up to a maximum of 300 ms. If an atrial event is detected within the AV delay and
the detected atrial rate is less than the programmed Mode Switch Detection rate, a 2:1 Lock-In is
conrmed.
Otherwise, 2:1 Lock-In is not conrmed, and the AV delay is gradually decreased to the programmed
value. The 2:1 Lock-In Management feature is suspended for 120 seconds.
PAGE 44
Page 53
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 conrmation 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.
In order to optimize the programmability of the 2:1 Lock-In Management feature, the far eld protection
period is programmable to allow the physician to ensure that the protection period is sufcient to
recognize cases where a 2:1 lock-in is likely to occur.
5.9 Atrial Upper Rate
The atrial upper rate (AUR) prevents atrial pacing from occurring in the vulnerable phase after an atrial
sensed event during the PMT protection interval, and ensures that the next atrial paced event occurs
after the heart’s natural atrial refractory period.
To avoid this, an atrial upper rate of 240 ppm (atrial upper interval (AUI), 250 ms) is started after
a PMT-As.
The next Ap can only be emitted after the expiration of the AUI. When there are high sensor rates, the
atrial pacing is shifted.
NOTE:
Right atrial pacing does not occur when mode switching is activated, and when the atrial upper rate
is activated in DDI mode at the end of the sensor or basic interval.
5.10 Atrial Overdrive Pacing (Overdrive Mode)
The atrial pacing rate increases after each atrial sensed event that is not classied as an atrial
extrasystole, in an attempt to suppress atrial tachyarrhythmias. The overdrive algorithm triggers atrial
overdrive pacing and guarantees that pacing occurs at a rate slightly above the intrinsic sinus rate.
Atrial overdrive pacing thereby minimizes the number of atrial sensed events. The overdrive mode is
available in DDD(R).
The features of Atrial Overdrive pacing include:
Figure 30: Overdrive Pacing
After every atrial sensed event (non-AES), the pacing rate is increased by a non-programmable 8 bpm
rate increase above the intrinsic event. This is shown as the overdrive step in Figure 30. The device will
pace at that rate (intrinsic + 8 bpm) for 20 cycles. At the end of those 20 cycles, the device will decrease
the pacing rate by 1 bpm/cycle until an intrinsic event is detected. Once an intrinsic event is detected, the
device will immediately increase the pacing rate to the new pacing rate (intrinsic rate + 8 bpm).
PAGE 45
Page 54
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.
Programming of Atrial overdrive pacing requires that the Basic rate to be at least 30 bpm less than the
Maximum Overdrive Rate. This also applies when performing an atrial threshold test and may require the
user to increase the MSR or turn off Atrial overdrive to perform the atrial threshold test at higher rates.
Protection Function of the Algorithm
Atrial overdrive pacing (Overdrive Mode) consists of different functions that become effective at high
atrial rates:
• When the maximum activity rate (MAR, standard setting 120 ppm, (90… (5)…160 ppm) is
exceeded as with atrial tachycardias, the algorithm is automatically deactivated. If the rate falls
below the MAR, the overdrive algorithm is reactivated.
• The function is deactivated when the mean of the atrial rate over a period of twelve hours exceeds
the average safety rate (“overdrive average rate limit = OAR”). The average safety rate is
determined indirectly from the maximum overdrive pacing rate (MOR minus 10ppm). If the average
safety rate is exceeded, the pacing rate is incrementally reduced to the basic rate. If the average
atrial heart rate falls below the average safety rate, the preventive overdrive pacing is reactivated
(activation/deactivation only in a 12 hour rhythm).
• If the function is deactivated for a third time because the average safety rate has been exceeded,
overdrive pacing remains OFF permanently. The overdrive mode can not be reactivated until after
the pacemaker has been programmed.
NOTE:
Atrial Overdrive cannot be programmed when CLS is active.
CAUTION
Overdrive Pacing Mode When programming the overdrive pacing
mode, check whether the selected program can cause PMT, and
whether atrial over drive pacing would result. Corresponding to the
measured retrograde conduction time, the PMT protection interval
must be programmed to a correct value.
5.11 Management of Specic Scenarios
5.11.1 PMT Management
A PMT is dened as a tachycardia caused by inadvertently tracking retrograde P-waves. The PMT
management feature includes PMT Protection/Termination and a programmable PMT detection and
termination algorithm.
5.11.2 PMT Protection
Pacemaker-mediated tachycardia (PMT) is normally triggered by ventricular depolarizations that are
not synchronized with atrial depolarizations (e.g., VES). The tachycardia is maintained in a retrograde
direction by intrinsic VA conduction of the stimulated ventricular depolarization and in an antegrade
direction by ventricular pacing of the pacemaker that is triggered by P-waves. It is the objective of the
atrial PMT protection interval to not use retrogradely conducted atrial sensed events for pacemaker
timing, but only to statistically evaluate them for detection of atrial tachycardia incidents.
PAGE 46
Page 55
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.
PMT Protection is an On/Off feature and is found on the Refractory Period / Blanking Screen. However,
it can only be programmed OFF when Auto PVARP is programmed OFF. Once activated, the VA
Criterion, nominally set to 350 ms, is programmable from 250...(10)...500 ms.
NOTE:
The initial values of the PMT protection interval in the automatic setting at 250 ms after a Vp, and 400
ms after PVC.
5.11.2.1 PMT Detection and Termination
In addition to PMT prevention, Evia CRT-P contains a programmable PMT detection and termination
algorithm. The termination feature will take action in case the prevention was not effective and a PMT is
detected. The PMT detection constantly monitors for the presence of a PMT.
The Evia CRT-P PMT detection/termination algorithm consists of suspicion, conrmation and
termination components and is described as follows.
Suspicion
A PMT is suspected when the following criteria are met:
• The heart rate is greater than 100 bpm.
• 8 successive V pace-A sense (Vp-As) sequences have occurred with a length shorter than the VA
criterion. This VA criterion is programmable between 250 and 500 ms.
• The mean deviation of these 8 Vp-As intervals is less than the Stability criterion parameter, defined
as less than 25 ms.
Conrmation
In order to conrm PMT, one of two actions is taken:
• If the suspected PMT is occurring at the Upper Tracking Interval (UTI), which occurs in most cases,
the UTI is increased to the next programmable length by 50 ms.
• If the suspected PMT is occurring at a rate that is slower than the UTI, the programmed AV Delay
is shortened to the next programmable length by 50 ms.
In either case, if the measured VA interval remains constant, PMT is conrmed, moving the algorithm to
the next phase, PMT Termination.
Interval Length AV Delay Test Method:
Atrial Tracked Rate Interval AV Delay Test Method
> UTI ≤ 200 ms Increase AV Delay by 50 ms
> UTI + 50 ms > 200 ms Decrease AV Delay by 50 ms
≤ UTI Any Increase UTI by 50 ms
> UTI and ≤ UTI + 50 ms > 200 ms
Set UTI = Atrial Tracked
Rate Interval + 50 ms
PAGE 47
Page 56
Chapter 5 Programmable Parameters
Evoked
Polarization
Captur
Non-
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. If no
additional PMTs arise within seven days, the length of the PMT protection interval is reduced by 50 ms.
The initial values of the PMT protection interval in the automatic setting at 250 ms after Vp and 400 ms
after a PVC.
5.13 Right/left Ventricular Capture Control (VCC)
5.13.1 Feature Description
The Right/Left VCC feature periodically measures the capture threshold, and automatically adjusts
the pacing output (with a programmable safety margin) independently for the Right and Left Ventricles
when programmed ON. Additionally, the feature continuously assesses ventricular pacing capture on a
beat-to-beat basis and responds to any loss of capture with a safety back-up pulse. During the clinical
evaluation of the Ventricular Capture Control algorithm, it was demonstrated that use of Ventricular
Capture Control can increase device longevity (as compared to standard programming).
Differences in the signal morphology between the polarization artifact and the evoked response signal
are used to distinguish capture events from non-capture events. The polarization artifact is the signal
caused by the pacing pulse between the pacing electrode and the cardiac tissue. The evoked response
signal is the intracardiac signal measured during electrical activation of the myocardium.
Figure 31 shows an example of an evoked response signal and a polarization artifact. After an effective
blanking period of 20 ms, the signal is evaluated over the next 60 ms. Several characteristics of the
signal falling into this window are evaluated in order to discriminate the evoked response (capture) from
polarization artifact (possible non-capture).
Figure 31: Example of a Capture and a Non-Capture Beat
Table 13 contains a list and description of the acronyms and terms pertaining to the VCC feature used
in this manual.
PAGE 48
Page 57
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.
When Ventricular Capture Control is ON, the feature will determine the capture threshold, program the
output, and provide continuous monitoring to insure capture is present.
The ATM mode differs from Capture Control ON as ATM does not automatically adjust the pacing
voltage. ATM instead stores the measured threshold values in the Pacing portion of the Statistics for
review, allowing it to be set by the clinician.
Threshold Test Start
2.4 V, 3.0 V, 3.6 V, 4.2 V and 4.8 V, default 3.0 V
This is the starting voltage when Capture Control (ON or ATM) is looking to determine the current
threshold. This value should only be changed to a higher value if the patient has high thresholds.
This is because the higher the output, the greater the polarization artifact which may cause the Signal
Quality Check to fail. This will be discussed in more detail later in this chapter.
Safety Margin
0.3 V...(0.1 V)...1.2 V; default of 0.5 V for the Right Ventricle
1.0 V, 1.2 V; default of 1.0 V when BiV pacing is programmed ON for the Right and Left ventricle
This is the amount of pacing output added to the threshold value to ensure capture. This takes into
account minor changes in thresholds throughout the day. For example, if the threshold was 0.7 V, the
device would add the 0.5 V safety margin to the 0.7 V threshold and program the pacing output to 1.2 V.
The lowest the output can be programmed is 0.7 V, regardless of the threshold.
PAGE 49
Page 58
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. This time may vary due to retesting
programming changes or threshold testing done after loss of capture. By default, it is set to once
every 24 hours.
• 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 AM. 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.
Term Denition
CV
ATM
Evoked Response
LOC
MaxVCCAmp
NC
Polarization Artifact
Safety Margin
SA
Capture Verication—A component of the VCC feature that provides
beat-to-beat classication of capture and non-capture.
Automatic Threshold Measurement—A component of the VCC feature
that periodically measures the ventricular pacing threshold. ATM can
only occur after a successful CV.
The intracardiac signal measured during electrical activation of the
cardiac tissue.
Loss-of-Capture—The VCC feature classies loss of capture when a
series of ventricular pacing pulses at varying AV delays did not capture
(with a maximum of 3 consecutive NC’s).
Threshold test start—This programmable parameter is the maximum
voltage setting that VCC will set after a successful CV.
Non-Capture—The VCC feature identies a non-capture as a single
ventricular pacing pulse without capture.
The signal or noise caused by the pacing pulse between the pacing
electrode and the cardiac tissue.
The safety margin is the difference between the pacing threshold and
the programmed pacing amplitude.
Signal Analysis—A component of the VCC feature that periodically
determines whether evoked responses are appropriately detected and
that pacing artifact is sufciently small in amplitude. If the SA determines
that the signal is not acceptable, then the other portions of the VCC
feature cannot be activated.
PAGE 50
Table 13: Acronyms and Terms
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 Verication. The following paragraphs describe the operation of these three components (SA,
ATM, and CV) of VCC while active in DDD(R) pacing mode. In the other modes (VDD(R) and VVI(R)),
there are slight variations in the operation of VCC.
Signal Analysis (SA)
A polarization artifact that is too large may disturb the cardiac signal following the pacing pulse and
result in misclassication of the event. Conversely, the evoked response signal may be too small or
may not meet the capture criteria, which again may lead to misclassication of the event. Therefore, the
SA analyzes the evoked response and the amplitude of the polarization artifact. A successful SA must
always be completed before the Capture Threshold Search or the activation of Capture Verication.
• SA is performed in two separate phases. In both phases, the AV delay is shortened to 50 ms after
a paced atrial event and to 15 ms after a sensed atrial event to ensure ventricular pacing. First, five
ventricular pacing pulses are delivered at MaxVCCAmp, which is the programmable maximum
voltage setting (2.4, 3.0, 3.6, 4.2, 4.8 V). If non-capture is detected at the maximum voltage setting,
the second phase of the SA is aborted and the test is classified as unsuccessful. In the next phase,
five “double” pacing pulses (one pacing pulse followed by another pacing pulse 100 ms later, in the
absolute refractory period) are delivered. These pulses are used to verify that the polarization
artifact is small enough to distinguish capture from non-capture. If the artifact following the second
pacing pulse is higher than a certain limit, then SA is classified as unsuccessful. If necessary, this
test can be repeated at a lower maximum voltage setting.
• If the first SA after activating VCC is not completed successfully, VCC is immediately disabled, and
the pacing amplitude is programmed to MaxVCCAmp. VCC then requires manual reactivation of
the feature with the programmer.
PAGE 51
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. The SA will be attempted up to three times. After
the 3rd failure, VCC is disabled, and the pacing amplitude is programmed to the MaxVCCAmp plus
the Safety Margin of 1.2 V. VCC then requires manual reactivation of the feature with the
programmer.
Automatic Threshold Measurement
• The Automatic Threshold Measurement is the component of the VCC feature that measures the
ventricular pacing threshold by stepping down the output until non-capture occurs.
• The Automatic Threshold Measurement occurs over a series of cardiac cycles and begins at the
threshold test start that decreases until capture is lost. AV delay is shortened to 50 ms after a
paced atrial event and to 15 ms after a sensed atrial 4event to ensure ventricular pacing.
• The pacing amplitude decrements with every paced beat by 0.6 V, until the first non-captured beat.
The algorithm then decrements by smaller increments of 0.1 V until the first failed capture, at which
point it determines that the capture threshold is preceding value. .
• If two out of three non-capture events are detected, the pacing amplitude is set to the sum of the
pacing threshold voltage and the programmed safety margin. If two non-captures are detected
when the voltage decrements are greater than 0.1 V, the pacing amplitude is set to the previous
amplitude and then the amplitude decrements by 0.1 V until the pacing threshold is determined.
When another two non-capture are detected, the previous voltage setting is the pacing threshold.
• The pacing amplitude is then set to the pacing threshold plus a programmable safety margin (0.5 V
through 1.2 V in steps of 0.1 V).
• In addition to performing the threshold search after a loss of capture, the search is also conducted
at a programmable interval or a specific time during the day to provide an accurate safety margin
even with gradual changes in the pacing threshold. Note that a CV initiated by spontaneous loss of
capture will reset the timer that triggers the next periodic measurement if the search is
programmed to interval.
Capture Verication (CV)
The Capture Verication function is the component of the VCC feature that provides beat-to-beat
capture verication. (Not available in the ATM mode).
• If VCC determines that capture has been maintained, then the pulse amplitude remains at that
current setting and no action is required.
• If VCC determines that non-capture (NC) occurred, then a safety back-up pacing pulse is delivered
at an increased energy (same output voltage and pulse width extended to 1.0 ms) within 130 ms
after the non-captured pacing pulse.
• If a series of ventricular pacing pulses at varying AV delays result in loss-of-capture, a Signal Analysis
(SA) and Automatic Threshold Search are initiated to determine the current pacing threshold.
PAGE 52
Page 61
Chapter 5 Programmable Parameters
Evia HF / HF-T Technical Manual
• The algorithm is designed to respond appropriately to fusion beats. In order to discriminate noncapture from fusion, a capture confirmation algorithm varies the AV delay after detection of noncapture in the dual chamber pacing modes. First, fusion is diminished by extending the AV delay. If
a second non-capture is detected, the AV delay is returned to the programmed AV delay. If a third
consecutive non-capture is detected, loss of capture is confirmed and a Signal Analysis and
Automatic Threshold Search are initiated. If the first event was truly fusion, the extended AV delay
could allow intrinsic conduction. The AV delay will not return to the normal programmed value until
ventricular pacing is required. In case the capture confirmation continues to detect non-captures
without detecting 3 consecutive non-captures, the algorithm shortens the AV delay (50 ms after an
atrial paced event and 15 ms after an atrial sensed event for up to 2 paced cycles) to confirm the
occurrence of non-capture. When VCC and CLS are both enabled, the AV delay is extended after
detection of non-capture and then capture confirmation is temporarily disabled while CLS performs
an AV Hysteresis Scan.
5.13.3.1 Algorithm Suspension, Abort and Disabling
The VCC feature is inactive until the rst SA and CV after programming is completed successfully.
The SA/CV sequence is unsuccessful when the SA or CV fail or are aborted. In addition, an SA/CV
sequence can be postponed and CV can be temporarily suspended.
The SA/CV sequence will fail when the following events occur:
• Non-capture during SA: non-capture occurs twice in the second through fifth cycles of the SA (at
the maximum voltage amplitude setting).
• High polarization artifact during SA: the polarization artifact measured during the SA is too high.
• No non-capture during CV: the threshold search decreases the output to 0.1 V without detecting
non-capture.
An ongoing SA/CV sequence will abort when the following events occur:
• Mode Switch: Mode switch has a higher priority than the SA/CV. If Mode switch aborts an SA/CV,
the device will be set to high output. After reversion back to the programmed mode, a new SA/CV
will be initiated.
• Programmer Wand application: An ongoing SA/CV aborts when a magnet (programmer wand) is
applied and the device is then set to high output. After removal of the magnet, a new SA/CV is
started.
• Search timer expiration (120 seconds): if the SA/CV takes longer than 120 seconds to be completed
(e.g. due to sensing), the SA/CV will be aborted and the device will be set to high output.
• Noise detection: if excessive noise is detected, the initial SA/CV will be aborted and the device will
be set to high output.
A SA/CV sequence will be postponed when the following events occur:
• Mode switch is ongoing: If Mode switch is ongoing when an SA/CV is scheduled, the SA/CV will be
postponed until reversion back to the programmed mode.
• The presence of a magnet is detected: A scheduled SA/CV is postponed when a magnet
(programmer wand) is detected. After removal of the magnet, the SA/CV is started.
• The ventricular rate is higher than 110 bpm: A scheduled SA/CV is postponed when the ventricular
rate is higher than 100 bpm. When the ventricular rate drops below 10 bpm, the SA/CV is started.
The continuous capture control (CV) will be suspended and the ventricular pacing amplitude is set to
high output when the following events occur:
PAGE 53
Page 62
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.
• Mode Switch: CV is suspended and the device is set to high output until reversion back to the
programmed mode.
The VCC feature will be automatically turned OFF when the following events occur:
• The initial SA/CV sequence after activating VCC failed
• Three subsequent and consecutive failed SA attempts
• The occurrence of 25 Losses of Capture between two consecutive days
• ERI: the device will be set to ERI mode with VCC OFF
• Unipolar lead failure is detected
The occurrence of these unsuccessful, aborted or postponed SA/CV sequences and disabling of the
VCC feature are reported in the Status log in the VCC statistics.
5.13.4 Ventricular Capture Control Programming
VCC is programmable to ON, Active Threshold Monitoring (ATM) modes, and OFF. Table 14 provides
details about the VCC programmability.
Programmable Modes for VCC
VCC Components ON ATM
Pulse width programmability less than or equal to 0.4 ms
SA and Capture Threshold searches Ye s Yes
Set output to threshold + safety margin Yes No
Capture Verication (CV) Yes No
Table 14: VCC Programmability
When programmed to ON, the device will continuously monitor the cardiac signal following the pacing
pulse to verify that a depolarization occurred as a result of the pulse. Upon detection of non-capture,
the device will issue a back-up pulse at a higher output (pulse width increased to 1 ms) within 130 ms.
If loss-of-capture (LOC) occurs, the device will initiate an SA/CV. Additionally, the device will perform
regular threshold searches at the programmed time each day. After a successful threshold search,
the device will program the pulse amplitude to the threshold plus the programmed Safety Margin. The
device will never set the amplitude lower than the xed minimum VCC Amplitude (Min Ampl.) of 0.7 V.
NOTE:
After programming the Ventricular Capture Control feature to ON or ATM, the device will perform a
Signal Analysis and a capture threshold search. This sequence can take up to 2 minutes.
5.14 Atrial Capture Control (ACC)
5.14.1 Feature Description
Automatic atrial threshold measurement can be performed during follow-up using the programmer. The
ACC feature periodically measures the pacing threshold and amplitude adjustment in the atrium. The
standard setting is one threshold measurement per day, but the user may choose another frequency
of measurement. The threshold search is based on the presence or absence of atrial sensing markers
generated by the device. The atrium is stimulated at a pacing rate higher then the intrinsic rate to
suppress atrial intrinsic events. As soon as the pacing output is lower then the atrial threshold, sensed
PAGE 54
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. The atrial capture control is performed in four steps:
1. Setup-Phase: The device monitors the rate and rhythm condition and determines the actual rate
in the atrium immediately before it starts the threshold search. Automatic measurements are
allowed if the atrial and ventricular rate is below 110 ppm and no mode switching is active. If
these conditions are met, the activation of the capture control algorithm causes a mode switch
to DDI with an atrial overdrive pacing of +20 % of the actual determined rate. The Ap-Vp interval
will be programmed to 50 ms, to avoid retrograde conduction from the ventricle.
2. Threshold search: The threshold is determined by decreasing the amplitude stepwise at a
programmed pulse duration until loss of capture occurs. Loss of capture for one test amplitude
is declared if in a test window of ve cardiac cycles (5 Ap-Vp intervals) two or more intrinsic
atrial events are sensed which indicates unsuccessful pacing.
3. Conrmation phase: The pacing threshold is considered to be conrmed if capture is determined
with the rst step and loss of capture is conrmed with the second step.
4. Amplitude adjustment: The pacing amplitude is dened by adding the programmed safety
margin to the determined threshold.
Parameters associated with Atrial Capture Control are shown in Table 15.
Parameter Range Default
Capture Control ON, ATM, OFF ON
Minimum Amplitude 0.5...(0.1)...4.8 V 1.0 V
Threshold Test Start 2.4, 3.0, 3.6, 4.2, 4.8 V 3.0 V
Safety Margin 0.3...(0.1)...1.2 V 1.0 V
Search Type Time of day, Interval Time of day
Time of Day 24 hour clock 2:00 A.M.
Interval 0.1, 0.3, 1, 3, 6, 12, 24 hr. 24 hr.
Table 15: Atrial Capture Control Parameters
Capture Control
Figure 34: Atrial Capture Control Screen
PAGE 55
Page 64
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. The device will then perform
routine threshold tests based on the programmed scheduled time.
The threshold value is stored in the measured threshold values in the pacing portion of the device
statistics as well as in the device follow-up history.
Atrial Capture Control will continue to test for atrial thresholds even when previous attempts have failed.
In other words, it will not disable the algorithm unless a lead failure or ERI is detected.
The ATM mode differs from Capture Control ON, as ATM does not adjust the pacing voltage
automatically. It does, however, store the measured threshold values in the pacing portion of the
Statistics for review and in the follow-up history of the device. In the ATM mode, the clinician controls
the pacing output.
Minimum Amplitude
0.5...(0.1)...4.8 V, default 1.0 V.
This is the minimum atrial pacing output to which the device can be automatically programmed,
regardless of the measured threshold. The Minimum amplitude can never be programmed higher than
the Threshold test start value. This restriction is shown by the symbol.
Threshold Test Start
2.4 V, 3.0 V, 3.6 V, 4.2 V and 4.8 V, default 3.0 V
This is the starting voltage when Capture Control (ON or ATM) is looking to determine the current
threshold. This value should only be changed to a higher value if the patient has high thresholds.
Safety Margin
0.5 V...(0.1 V)...1.2 V, default of 1.0 V
This is the amount of pacing output added to the measured threshold value to ensure capture. This
takes into account minor changes in thresholds throughout the day. For example, if the threshold was
0.7 V, the device would add the 1.0 V safety margin to the 0.7 V threshold and program the pacing
output to 1.7 V. The lowest the output that can be programmed is the Minimum amplitude value,
regardless of the threshold.
5.14.2 Search Type
Interval / Time of Day
This feature determines when the device performs a 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. The interval begins with a permanent program
being sent to the device. This time may vary due to retesting or programming changes. By
default, it is set to once every 24 hours.
PAGE 56
Page 65
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.
5.15 Ventricular Pace Suppression (Vp-Suppression)
5.15.1 Feature Description
Vp-Suppression is a feature that is available in DDD(R)-ADI(R) mode and is not available with
biventricular pacing. This feature promotes the intrinsic AV conduction by only pacing the ventricle
when intrinsic conduction becomes unstable or disappears. Depending on the presence or absence of
AV conduction, the feature is implemented either in the ventricular pacing suppression state ADI(R),
which promotes the intrinsic conduction, or in the DDD(R) ventricular pacing state Vp DDD(R), which
provides ventricular pacing. Automatic switching capabilities between those two states promote
the intrinsic conduction as much as possible without harming the patient. Scheduled Vs searching
tests look for intrinsic conduction using an extended AV delay of 450ms. In order to protect the
patient from high ventricular rates, the feature provides Mode Switching independent of the present
state of the algorithm. The feature itself becomes suspended for the time of Mode Switching. When
Vp-Suppression becomes enabled, the device starts in the Vp-DDD(R) state and looks for intrinsic
conduction by starting a Vs-searching. Following any suspension (e.g. Mode Switch), the Vp
Suppression feature will resume in Vp-DDD(R) state. The feature provides user programmability with
respect to the switching criteria in order to support intrinsic conduction.
5.15.2 Programmability
The Vp-Suppression feature will provide the following programmability as shown in Table 16.
Parameter Range Default
Vp-Suppression feature On, Off Off
VpS to DDD(R) x/8 cycles without VS 1,2,3,4 3
DDD(R) to VpS x consecutive Vs 1,2,3,4,5,6,7,8 6
Table 16: Vp-Suppression Parameters
Vp-Suppression is available only if DDD(R)-ADI(R) mode is selected.
5.15.3 How the Vp Suppression Algorithm Works
Once the algorithm is programmed ON and the wand is removed, a Vs Continuity test is performed with
the rst intrinsic ventricular event or after 30 seconds of ventricular pacing whichever comes rst.
A Continuity test is used to determine whether a stable intrinsic ventricular rhythm is present. During
the test, the AV Delay is extended to 450 ms for eight cycles. During those eight cycles, the device
looks to determine if six out of eight Vs events occur. If six Vs events occur, Vp Suppression is
activated. If six events do not occur, the device will return to the programmed AV Delay and a new
search will be performed at a specic time interval. More detail on search intervals will be found in the
following section, Intelligent Search.
While the device is in the ADI(R) mode, pacing is available only in the atrium. The AV Delay is set to
450 ms in the background without delivering a pace if the AV Delay timer expires.
PAGE 57
Page 66
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. After that, the device will search every 20 hours. The rationale for 20 hours is to allow
the device to perform searches during different times of the day to improve the chances of success.
Search Time Interval Scheme
30 sec. > 1 min. > 2 min. > 4 min. > 8 min. > 16 min. > 32 min. > 64 min. > 128 min. > 20 hr.
Switching Back to DDD(R)
The following criteria will cause the device to switch back to DDD(R):
• No Vs for two seconds
• Two consecutive cycles without a Vs event
• A programmable number of cycles without a Vs out of eight cycles (Default is three out of
eight cycles)
In the presence of a Mode Switch event, the device will switch to the programmed Mode Switch Mode.
Once the Mode Switch event is over, the device will switch back to the DDD(R) mode and then initiate
the Continuity test for the Vp Suppression algorithm.
If a patient has unstable AV conduction, the algorithm may switch to an ADI(R) mode frequently. The
number of times the device can switch to Vp Suppression is limited to 15 attempts per hour. When
the limit is reached, the Vp Suppression feature is suspended until midnight (12:00 AM) and will then
resume the Continuity test starting with the 30 second search interval.
Interaction of Vp Suppression with other Algorithms
The following events will interrupt the Vp Suppression algorithm:
• Wand application
• PMT Detection
• Mode Switch
The algorithm is disabled when the device enters the ERI state.
5.16 Thoracic Impedance
The thoracic impedance is measured between the distal electrode of the RV lead and the pacemaker
housing. 8 measurements per hour are done and these measurements are then averaged. The 24
measurements per day are stored in the device and transmitted via Home Monitoring as a single
averaged data point. The Home Monitoring website then displays a trend of the daily average. The
same trend of daily TI averages is displayed on the programmer upon interrogation of the pacemaker.
The TI trend does not replace assessments that are part of standard of care for the clinical practice.
The clinical value of this feature has not been established for the management of patients.
5.17 ProgramConsult
®
ProgramConsult® provides clinicians with the option to increase programming efciency by providing
programming suggestions for frequent pacemaker patient conditions and having the capability to
store individual programming for future usage (can store up to three individual parameter sets for
future programming).
PAGE 58
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.5 ProgramConsult only shows recommendations
for specic parameter settings to the user and clearly highlights them as modications to the active
permanent program prior to making any changes to device programming.
This feature is part of the programmer parameter section and is located on the main Evia CRT-P
programmer screen under the selection Program Sets. Upon selection of ProgramConsult, a subwindow opens with multiple selections depending on the underlying disease. Upon selection of a
particular option, the parameter page displays the suggested parameter values in blue color. This
indicates the recommended setting changes to the user (from the current settings) so that they can
conrm them prior to activation. If desired, modications can be made prior to transmitting the new
program to the pulse generator as an updated permanent program. Table 17 compares the suggested
ProgramConsult and standard parameters for different patient conditions:
HF with normal
sinus function
Mode DDD VVI-CLS DDD-CLS DDD-CLS DDD-CLS
Basic Rate 50 70 50 50 50
Night Rate OFF -- -- -- --
Rate Hysteresis (ppm) -10 -- -- -- --
Rate Hysteresis Rep/
Scan Cycles
Max Sensor Rate 130 120 90 120 120
CLS Response -- Medium Low Medium High
CLS – Resting Rate
Control
Upper Tracking Rate 140 -- 130 130 130
Atrial Upper Rate 240 -- 240 240 240
Mode Switch ON -- ON ON ON
Intervention Rate 160 -- 160 160 160
Switch to DDIR -- DDIR DDIR DDIR
Onset Criterion 5 -- 5 5 5
Resolution Criterion 5 -- 5 5 5
Change of basic rate 10 -- 10 10 10
Rate Stabilization OFF -- OFF OFF OFF
2:1 Lock-in protection -- -- -- -- --
Ventricular pacing BiV BiV BiV BiV BiV
Triggering RVs RVs -- -- --
Max trigger rate Auto Auto Auto Auto Auto
Initially paced chamber LV LV -- -- --
VV Delay after Vp 20 -- -- -- --
5 -- -- -- --
-- 20 20 20 20
HF with
permanent AF
HF with low
CLS response
HF with medium
CLS response
HF with high
CLS response
5 ACC/AHA/HRS 2008 Guidelines for Device-Based Therapy of Cardiac Rhythm Abnormalities: Executive Summary: A Report of the
American College of Cardiology/American Heart Association Task Force on Practice Guidelines (Writing Committee to Revise the ACC/
AHA/NASPE 2002 Guideline Update for Implantation of Cardiac Pacemakers and Antiarrhythmia Devices) Developed in Collaboration
With the American Association for Thoracic Surgery and Society of Thoracic Surgeons. Andrew E. Epstein, John P. DiMarco, Kenneth A.
Ellenbogen, N.A. Mark Estes, III, Roger A. Freedman, Leonard S. Gettes, A. Marc Gillinov, Gabriel Gregoratos, Stephen C. Hammill, David
L. Hayes, Mark A. Hlatky, L. Kristin Newby, Richard Page, Mark H. Schoenfeld, Michael J. Silka, Lynne Warner Stevenson, and Michael
O. Sweeney
PAGE 59
Page 68
Chapter 5 Programmable Parameters
Evia HF / HF-T Technical Manual
HF with normal
sinus function
Mode DDD VVI-CLS DDD-CLS DDD-CLS DDD-CLS
AV Delay 1 150 -- 150 150 150
AV Delay 2 140 -- 140 140 140
AV Delay 3 130 -- 130 130 130
AV Delay 4 120 -- 120 120 120
AV Delay 5 110 -- 110 110 11 0
Sense Compensation -45 -- -45 -45 -45
RA Capture Control ON -- ON ON ON
Threshold test start 3.0 -- 3.0 3.0 3.0
Safety Margin 1.0 -- 1.0 1.0 1.0
Search type Time of Day -- Time of Day Time of Day Time of Day
Time of day 2:00 -- 2:00 2:00 2:00
RV Capture Control ON ON ON ON ON
Threshold test start 3.0 3.0 3.0 3.0 3.0
Safety Margin 1.0 1.0 1.0 1.0 1.0
Search type Time of Day Time of Day Time of Day Time of Day Time of Day
Time of day 2:00 2:00 2:00 2:00 2:00
LV Capture Control ON ON ON ON ON
Threshold test start 3.0 3.0 3.0 3.0 3.0
Safety Margin 1.0 1.0 1.0 1.0 1.0
Search type Time of Day Time of Day Time of Day Time of Day Time of Day
Time of day 2:00 2:00 2:00 2:00 2:00
PMT ON -- ON ON ON
High Atrial Rate Mode Switch -- Mode Switch Mode Switch Mode Switch
High Ventricular Rate ON ON ON ON ON
Patient trigger OFF OFF OFF OFF OFF
Pre Trigger Recording 75 75 75 75 75
IEGM signal Filtered Filtered Filtered Filtered Filtered
HAR limit 200 -- 200 200 200
HVR limit 160 160 160 160 160
HVR counter 8 8 8 8 8
Thoracic Impedance ON ON ON ON ON
Home Monitoring ON ON ON ON ON
Time of Transmission AUTO AUTO AUTO AUTO AUTO
HF with
permanent AF
HF with low
CLS response
HF with medium
CLS response
HF with high
CLS response
Table 17: ProgramConsult
5.18 Home Monitoring (Evia HF-T)
Home Monitoring enables the exchange of information about a patient’s cardiac status from the implant
to the physician. Home Monitoring can be used to provide the physician with advance reports from the
implant and can process them into graphical and tabular format called a Cardio Report. This information
helps the physician optimize the therapy process, as it allows the patient to be scheduled for additional
clinical appointments between regular follow-up visits if necessary.
PAGE 60
Page 69
Chapter 5 Programmable Parameters
Evia HF / HF-T Technical Manual
The implant’s Home Monitoring function can be used for the entire operational life of the implant (prior
to ERI) or for shorter periods, such as several weeks or months.
Home Monitoring can be utilized as a functional replacement for in-ofce follow-up visits and allows
the time between routine, scheduled, in-ofce follow-ups of BIOTRONIK implantable devices to be
extended to twelve months or more. Home Monitoring evaluation of implanted devices and patient
status is as safe as conventional in-ofce follow-ups. BIOTRONIK’s Home Monitoring system provides
early detection of arrhythmic events and of silent, asymptomatic events. Automatic early detection of
clinical events by Home Monitoring leads to earlier intervention than conventional in-ofce follow-ups
and improves adherence to scheduled follow-ups.
NOTE:
When ERI mode is reached, this status is transmitted. Further measurements and transmissions of
Home Monitoring data are no longer possible.
5.18.1 Transmission of Information
The implant transmits information with a small transmitter, which has a range of about 6 feet (2
meters). The patient’s implant data are sent to the corresponding patient device in congurable periodic
intervals.
The minimal distance between the implant and the patient device must be 6 inches (15 cm).
5.18.2 Patient Device
The patient device is designed for use in or away from the home and is comprised of the mobile unit
and the associated charging station. The patient can carry the mobile unit during his or her occupational
and leisure activities. The patient device is rechargeable, allowing for an approximate operational time
of 24 hours. It receives information from the implant and forwards it via the cellular mobile network or
the standard telephone system to a BIOTRONIK Service Center.
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. The Cardio Report is sent to the attending
physician via fax or is available on the Internet, which is selected during registration of the patient. For
more information on registering for Home Monitoring, contact your BIOTRONIK sales representative.
The password protected BIOTRONIK Home Monitoring website can be accessed at the following URL:
www.biotronik-homemonitoring.com
An online help menu is available in order to assist with the use of the Home Monitoring website.
Use of the Internet for reviewing Home Monitoring data must be in conjunction with the system
requirements listed in Table 18.
PAGE 61
Page 70
Chapter 5 Programmable Parameters
Evia HF / HF-T Technical Manual
System Requirements
Screen Resolution 1024 x 768 ≥ 1280 x 1024
Internet Bandwidth 56 kB/sec
PC
Internet Browser MS Internet Explorer 5.5
Acrobat Reader Version 6.1 Version 6.1 or higher
Communication
Channel
Additionally, the attending physician may register to be informed of the occurrence of an Event
Triggered Message through email or SMS (i.e., mobile phone) with a brief text message. If registered
for Internet availability, the patient’s detailed implant data can then be viewed by logging onto the Home
Monitoring website.
800 MHz Pentium
processor, 128 MB RAM
Fax (G3) or e-mail Fax (G3), e-mail or mobile phone
Table 18: System Requirements / Recommendations
System Recommendations
(for Optimal Usage)
≥ 128 kB/sec
(DSL, cable modem)
N/A
≥ MS Internet Explorer 5.5
- or -
≥ Mozilla 1.8 (Firefox ≥ 2.0)
5.18.4 Types of Report Transmissions
When the Home Monitoring function is activated, the transmission of a report (Cardio Report) from the
implant can be triggered as follows:
• Trend report—the time period (daily) initiates the report
• Event report—the pulse generator detects certain events, which initiate a report
5.18.4.1 Trend Report
The time of the report transmission is programmable. For periodic messages, the time can be set
anywhere between 0:00 and 23:59 hours. It is recommended to select a time between 0:00 and 4:00.
The length of the time interval (monitoring interval) is preset to “daily”. For each monitoring interval, a
data set is generated in the implant and the transmission is initiated at the designated time.
5.18.4.2 Event Report
When certain cardiac and technical events are detected by the implant, a report transmission is
automatically triggered. This is described as an “event message” as part of the daily transmission.
The following clinical and technical events initiate a Home Monitoring message transmission:
• Atrial Lead Check < 100+/-50 Ohm and > 2500+/-500 Ohm
• Right/Left Ventricular Lead Check < 100+/-50 Ohm and > 2500+/-500
• RVCC/LVCC Disabled
• ERI detected
• Atrial Capture Control Disabled
• High Ventricular rate
• Atrial tachyarrhythmia persisting beyond a programmable time limit or
PAGE 62
Page 71
Chapter 5 Programmable Parameters
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. In addition to the
medical data, the serial number of the implant is also transmitted.
The Monitoring Interval
The monitoring interval is considered the time period since the last periodic message was transmitted.
In a periodic report, the monitoring interval since the previous periodic report would be 24 hours.
The following data are transmitted for the Cardio Report by the Home Monitoring system, when
activated. In addition to the medical data, the serial number of the implant is also transmitted.
Device Status & Home Monitoring Settings
Containing device and message identifying values that pertain to the implant and Home Monitoring:
• Implantation Date
• Device Status
• Remaining capacity for ERI calculation (done by the Service Center)
• Last Follow-up
• Message Creation Date/Time
• Device Serial Number
Leads
• Automatic Threshold Monitoring
• Measured RV pacing threshold
• LV enabled/disabled
• RV enabled/disabled
• RA enabled/disabled
• Date/time of ATM measurement
• Pacing Impedance (RA, RV, LV)
• Sensing Amplitude (RA, RV, LV)
Pacing Counters (Brady)
• AV-Sequences
• Intrinsic Rhythm (AsVs)
• Conducted Rhythm (AsVp)
• Atrial Paced Rhythm (ApVs)
• Complete Paced Rhythm (ApVp)
Atrial Arrhythmia
• Atrial Tachy Episodes (36 out of 48 criteria)
• Counter on AT/AF detections per day
• Atrial Burden per day°
• Ongoing Atrial Episode Time (programmable for 6, 12 or 18 hrs)
PAGE 63
Page 72
Chapter 5 Programmable Parameters
Evia HF / HF-T Technical Manual
• Mode Switching
• Number of Mode Switches
• Duration of Mode Switches
Ventricular Arrhythmia
• High Ventricular Rate Counters
Transmitted Device Settings
The primary programmed parameters for the following are sent in the data package:
• Leads—(e.g., Pacing Output, Configuration)
• Brady—(e.g., Basic Rate, UTR, AV-Delays, RV Sensitivity)
• I-OPT—(ON/OFF)
• HM Settings—(e.g., ON/OFF, transmission time (daily), IEGM transmissions ON/OFF, periodic
IEGM, ongoing atrial episode, statistics, holter)
• 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.
The following markers are also transmitted: AS (including Ars), AS (PMT), AP, RVS/LVS (including RVrs)
and RVP/LVP.
The Evia HF-T includes a programmable parameter to disable or enable the IEGM transmission.
PAGE 64
Page 73
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.
Timing
• Event Counters
• Event Episodes
• Rate Trend 24 hours
• Rate Trend 240 days
• Rate Histograms
Atrial Arrhythmia
• Atrial Burden
• Time of Occurrence
• Mode Switching
Sensor
• Sensor Histogram
• Activity Report
Sensing
• P/R -wave Trends
• Far Field Histogram
• As-Vs Interval Distribution Curve
• Ap-Vs Interval Distribution Curve
Ventricular Arrhythmia
• PVC
• Couplets
• Triplets
• Runs 4…8
• Runs > 8
• High Ventricular Rate Episode Count
Pacing
• Lead Impedance Trends
• Pulse amplitude / Threshold Trend
• Pulse Amplitude Histogram
• Capture Control Status
Heart Failure Monitoring
• Mean Rate
• Heart Rate Variability
• Patient Activity
• Thoracic Impedance
PAGE 65
Page 74
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.
The counters within the statistic features are reset each time the pulse generator is permanently
programmed.
The histogram bars are standardized to a rate class width of 10 ppm to avoid distortion of the rate
distribution that would be caused by varying rate class widths. The formula is:
percentage of total events occurring represented by
Bar Length =
the events counted in this class x 10
rate width of this class
6.2 Timing Statistics
6.2.1 Event Counter
The event counter totals all of the sensed and paced events. With the event counter, the following
events and event sequences can be registered over several years:
Listed is a summary of what each event means:
Event Counters
In the Event counters, shown in Figure 35, the legend is as follows:
As - refers to atrial sensed events.
As (PVARP) - refers to atrial events occurring during the PVARP period, but outside the FFP
period.
Ars - atrial events occurring during the atrial refractory period or during Mode Switching in which
the A-A period is less than the programmed atrial refractory period.
Ars (FFP) - events occurring on the atrial channel within the programmed far-eld protection
period of either ventricular paced or sensed events. Events in this window are not used towards
Mode Switching.
Ap - atrial paced events.
RVs - RV sensed events.
RVES - RV extrasystoles (PVCs).
Evia CRT-P denes a PVC as two ventricular events without an atrial event in between. A VT
with a slower atrial rhythm will have those events following the atrial events classied as Vs
events
RVrs - RV refractory sensed events occurring within the programmed ventricular refractory
period of the device.
RVp - RV paced events.
LVs - LV sensed events.
LVrs - LV refractory sensed events occurring within 200 ms of the previous LV event.
LVp - LV paced events.
PAGE 66
Page 75
Evia HF / HF-T Technical Manual
Figure 35: Event Counters in the Timing Bradycardia Statistics
Chapter 6 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.
RVrs events are those RV events within 200 ms of the preceding RV sensed event. The 200 ms
sensed refractory period is non-programmable.
RVES = Right ventricular extra systole (PVC), dened by the device when the following criteria are met:
• Two ventricular events with no Ap or As in between
• An Ars did not occur within 350 ms of the subsequent Vs event
Ars (PVARP) are those events falling into the PVARP timer and outside the Discrimination after As
window. Likely examples of these types of events include non-conducted PAC events or events
occurring during Mode Switch.
Ars events are those events occurring during an AV Delay window.
NOTE:
All event counter data are transmitted to the programmer and evaluated there, but not all events are
displayed in detail on the programmer.
6.2.2 Event Sequences
Event sequences, shown in Figure 36, provide the percentage of each state of pacing in the
Evia CRT-P.
This statistic provides information related to sinus and AV node function. A high percentage of Ap - Vx
events may suggest problems with the sinus node. A high percentage of Ax - Vp events may suggest
problems with the AV node conduction. Vx - Vx events may suggest one of the following: PVCs, atrial
undersensing, run(s) of VT or a sinus tachycardia in which atrial events fall in the FFP window.
PAGE 67
Page 76
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.
The rst graph shows the percentage of each Ax to Vx sequence.
Vx-Vx events must meet the following criteria:
• Two ventricular events with no Ap or As event in between
• An Ars did not occur within 350 ms of the subsequent Vs
The second graph shows the percentage of ventricular events with the potential to be resynchronized
based on device programming.
LVp Exclusive and LVp Exclusive Inhibited are parameters not available in the U.S.
RVs without LVp counter is only active when RVs triggering is turned ON. If RVs triggering is turned
ON, the counter provides the percentage of LV-RV sequences where RVs occurs without an LVp. If the
RVs triggering feature is turned OFF, this counter will display 0%.
PVC-triggered LVp is the percentage of all LV-RV sequences where an LVp was triggered off of a PVC.
If RVES triggering is turned OFF, this sequence will show 0%.
PVC without LVp is only active when RVES triggering is turned ON. If RVES triggering is turned ON,
the counter provides the percentage of LV-RV sequences where a PVC occurs without an LVp. If the
RVES triggering is turned OFF, this will display 0%.
6.2.3 Rate Trend 24 Hours
The rate trend is displayed as a trend chart and consists of the heart rate trend and the pacing rate trend.
The atrial and ventricular events recorded at a set time. In the rate trend, the heart rate in pulses per
minute (ppm) is recorded in the upper rate chart, and the percentage of pacing is shown in the lower
chart. These points represent an average of 11 minutes of collected data. Please note that a gap in the
trend will be displayed for the duration of an asynchronous magnet program or temporary program.
PAGE 68
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).
Data are collected every 11 minutes and displayed on this graph. The heart rate and pacing
percentage are collected and displayed for each recording period. The graph is rolling, keeping only
the most current data.
Ars (FFP) and Vrs events are not counted in the Rate Trend.
Key Points:
The 24 hour rate trend provides a time-based prole of atrial and ventricular rates, plotted separately
for up to 24 hours prior to follow-up.
The rate trend is based upon As, Ap, Ars, As(PVARP) Vs, Vp, PVC, and Vrs.
The paced display shows the percentage of paced events in each chamber over the 24 hours prior to
follow-up.
Divergence of the atrial line and ventricular line indicates a loss of AV synchrony, which could be due to:
• Mode Switching
• PVCs
• Upper Rate Behavior (Wenckebach, 2:1)
• Far-field Sensing
PAGE 69
Page 78
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).
Data are collected every 24 hours and displayed on this graph. The graph is rolling, keeping only the
most current 240-day data.
The heart rate is the average heart rate over a particular 24-hour recording period. The percentage
pacing is the percentage derived during that particular 24-hour recording period.
As (FFP) and Vrs events are not included in Rate Trend 240 days.
Key Points:
The Long Term Rate Trend shows the rate of each chamber plotted separately for the duration of the
statistics.
The Rate Trend is based upon As, Ap, Ars, As(PVARP), Vs, Vp, PVC, and Vrs events.
The Paced Trend shows the percentage of paced events in each chamber for the duration of the
statistics.
This diagnostic is useful to assess any changes to the patient’s state of pacing, dependency on the
device, or occurrence of arrhythmias.
PAGE 70
Page 79
6.2.5 Atrial and Ventricular Rate Histogram
Figure 39: Rate Histogram
Chapter 6 Statistics
Evia HF / HF-T Technical Manual
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.
Touching the screen or using the arrows on the left side of the screen or inside the graph moves the
cursor to different heart-rate bins and shows the amount of pacing or sensing in each rate bin, as well
as the event count in each rate bin.
The gray portion of the chart represents the heart rate range up to the Max activity rate.
The Max activity rate represents the programmed maximum sensor rate value, regardless of whether
the sensor is active.
Key Points:
The Rate Histogram displays the percentage of paced and sensed events in each rate bin listed along
the horizontal axis.
The Rate Histogram is based on Ap, As, Ars, As(PVARP), Vp, Vs, PVC, and Vrs.
Atrial and ventricular rates are plotted on two separate graphs: atrium on the top and ventricle on bottom.
Paced events are lighter in color and sensed events are darker.
A high percentage of atrial events in the upper rate bins may indicate atrial arrhythmias, but could also
be due to far-eld oversensing.
Atrial or ventricular events below the basic rate may be due to PVCs resetting the basic rate interval or
atrial undersensing.
NOTE:
The bars of the histogram are standardized to a rate class width of 10 ppm to avoid distortion of the
rate distribution.
PAGE 71
Page 80
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, Figure 40, displays the number of atrial tachycardia events per day and the
duration of these events. The scalar will automatically adjust based on the number and duration of the
events. The device will store data for the last 240 days. After 240 days, the device will overwrite the
oldest information to make room for current information.
The Atrial burden statistics require the parameter High Atrial Rate (HAR) trigger to be turned ON.
The rate that is programmed in the HAR limit becomes the low-rate cut-off value. Atrial burden is not
recorded until the 36/48 event above the programmed high atrial-rate criteria is met. Recording is
stopped when the termination count of 24/36 is met.
Mode Switch events that do not meet the HAR criteria of 36/48 will not be counted toward atrial burden
or time of occurrence.
The Mode Switch count and the time of occurrence count for AT events may not match for the
following reasons:
• Mode Switch events are too short to meet the AT count of 36/48 beats for atrial rate
detection criteria
• The patient has SVTs slower than the High Atrial Rate (default 200 bpm).
The Atrial burden statistic has a link at the bottom of the page, the “Set Arrhythmia detection
parameters” link. This takes the user to the Holter trigger set-up page. Holter trigger set-up is
described in Chapter 2.
Key Points:
The Atrial Burden diagnostic gives information on atrial arrhythmias throughout the duration of the
statistics.
All data is based only on atrial rates above the AT/AF rate (nominally 200 bpm but programmable under
the diagnostics parameters).
PAGE 72
Page 81
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 Figure 41, summarizes the times of day that atrial tachyarrhythmia
episodes began and is broken into three-hour time blocks. Knowing the time of day when
atrial tachyarrhythmias begin may help determine whether a particular event will precipitate the
tachyarrhythmia.
The total number of events is listed at the bottom of the graph.
Figure 41: Time of Occurrence
6.3.3 Mode Switching
Mode Switching shows the total number Modes switches that have occurred along with the total time of
Mode switching since the last follow-up. The intervention rate is also displayed.
Figure 42: Mode Switching
PAGE 73
Page 82
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.
NOTE:
If two mode switch events occur within 25 seconds of each other, the device will count two events, but
only one Holter may be recorded.
6.3.4 Ventricular Arrhythmia
The PVC sequences graph provides information related to the number and type of PVC sequences.
These sequences include single PVC events, couplets, triplets, runs of 4-8 events and runs of more
than eight events.
Figure 43: Ventricular Arrhythmia Screen
Evia CRT-P counts each type of PVC sequence. Each sequence is counted in the sum total below the
bar graph in Figure 43. The Sum value is the total number of sequences that have occurred. Each
sequence is also given a percentage value; comparing each event sequence against the total number
of event sequences.
The Ventricular statistic also displays the total number of HVR events that have occurred.
Key Points:
In order to be counted, PVCs must meet the following criteria:
• Two ventricular events with no Ap or As in between
• An Ars occurring more than 350 ms from the subsequent Vs.
An increase in PVC/h may indicate greater susceptibility to ventricular arrhythmias.
If the patient has a large amount of PVCs causing a low CRT pacing percentage, programming RVES
triggering ON may improve the CRT pacing percentage.
A high number of PVCs may indicate atrial undersensing.
PAGE 74
Page 83
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
classied 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. This feature is designed to improved event classication but
could classify PVC events as As Vs events if an atrial intrinsic event occurs within the 350 ms window
(400 ms window if I-Opt is programmed).
NOTE:
If in DDD(R) and atrial undersensing occurs, spontaneously conducted ventricular events are
evaluated as PVC events. For this reason, we recommend using the PVC analysis in DDD(R) mode
only in conjunction with bipolar sensing and an appropriately high atrial sensitivity.
The interval between two consecutive PVC events must be shorter than 500 ms (i.e., over 120 ppm)
for them to be counted. Otherwise, the second PVC will be ignored and the sequence interpreted or
terminated. This predominantly eliminates the possibility of PVC events being miscounted as a result of
atrial undersensing.
6.4 Sensor Statistics
6.4.1 Sensor Histogram
This function records how often the sensor rate is within certain ranges. The rate range is subdivided
into 16 rate classes going from 40 to 180, including bins for rates < 40 bpm and rates > 180 bpm. The
percentage and total number of sensed and paced events occurring within a rate class is displayed.
Sensor rate recording is independent of the effectiveness of the respective pacing rate, and it is not
inuenced by inhibition of pacing due to spontaneous events. Rate data are also recorded in non-rateadaptive modes.
Recording stops when the memory available for recording the sensor rates is full. Recordings can be
stored for several years. The frequency distribution of the sensor rates can be displayed as a diagram
during follow-up examinations.
Figure 44: Sensor Histogram
The Sensor rate histogram graph in Figure 44 shows the sensor activity during the recording time.
Data is collected even if the device is programmed to a non-sensor mode to demonstrate what the
sensor response would have been. In chronotropically incompetent patients, one would expect this
PAGE 75
Page 84
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. In each bin, the percentage of
the time in that particular bin is shown at the top of the graph when that bin is selected.
Key Points:
The Sensor Rate histogram displays the distribution of rates determined by the accelerometer.
The Sensor Rate histogram is updated in R- and non-R-modes.
The Sensor Rate histogram is updated regardless of whether sensor indicated pacing is inhibited by
intrinsic events.
NOTE:
When Event Counters exceed 8 digits, they are presented in exponential form. Heart Rate and Sensor
Rate Histograms will switch to exponential form when the Counters exceed 6 digits (e.g., 1,000,000
events will appear as 1.0E + 06).
6.4.2 Activity Report
Figure 45: Activity Report
The Activity report provides information regarding the activity level of the patient. The graph is divided
into three sections: No activity, Activity and Max Sensor Rate.
6.4.2.1 No Activity
This correlates to a patient being at rest. High values in this bin would suggest that patient is inactive
and, therefore, the sensor is not moving off its baseline mark.
If patients do not appear to be getting the appropriate rate response for their activity, a high value in the
No activity bin may also suggest the sensor threshold may not be appropriate for the patient. Further
evaluation would need to be performed.
PAGE 76
Page 85
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.
6.4.2.3 Max Sensor Rate
This represents how much time the sensor-indicated rate is at the programmed maximum sensor rate.
Active patients may have relatively high percentages of time in this bin. For example, a runner who
runs an hour a day, reaching his or her max sensor rate, may expect to have a max sensor activity
value at 4%. Typically, many patients will have no or a very small percentage in this bin.
This data can assist in the analysis of heart and sensor activity. For example, a high value for the
activity may indicate that the sensor gain is set too high. In contrast, an extremely low value for activity
may indicate that the sensor gain is too low.
6.5 Pacing Statistics
6.5.1 Lead Impedance Trends with Lead Check
Evia CRT-Ps can perform lead impedance measurements for the atrial and right/left ventricular leads.
These measurements are stored in memory for use in lead impedance trend data as a function of time.
The pace current and voltage is measured in order to determine the lead impedance.
Every 30 seconds, the lead impedance measurements are taken and are available for diagnostic trend
display. The programmer will display a long-term trend of 240 days.
Impedance trends are always recorded. The lead impedance measurements are used to determine if a
lead failure has occurred. The range for normal lead impedance is from 100 to 2500 ohms.
If the Evia CRT-P detects a bipolar lead failure, polarity for the respective lead will automatically be
changed to unipolar conguration. A bipolar lead failure is veried if the lead impedance measurement
falls outside of the acceptable range for three consecutive readings. When a lead failure has been
detected, a message is displayed on the programmer screen at the next follow-up visit in order to notify
the physician of the change.
Lead Check is temporarily suspended during magnet application and is inactive during ERI.
Figure 46: Lead Impedance Trend
PAGE 77
Page 86
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.
The device measures both unipolar and bipolar impedances. If the device is programmed bipolar,
the bipolar values will be displayed. If the device is programmed unipolar, the unipolar values will be
displayed.
The data trend duration is 240 days. After 240 days, the device will overwrite the oldest data.
6.5.2 Pacing Amplitude Histogram
This function records how often the atrial and right/left ventricular pulse amplitudes are within specic
ranges. The rate range is subdivided into categories ranging from 0.1 V to > 6.0 V. The ventricular
pacing amplitude is sampled at 2 second intervals and entered in the histogram. The percentage and
total number of 2 second intervals occurring within an amplitude class is displayed.
Recording stops when ACC or RVCC/LVCC are disabled between follow-ups or if the memory available
for recording the ventricular amplitude is full. Data may be recorded for several years. The frequency
distribution of the sensor rates can also be displayed as a diagram during follow-up examinations.
Figure 47: Pulse Amplitude/Threshold Trend
The Pulse amplitude/Threshold trend in Figure 47 shows the thresholds determined from the capture
control testing. The last threshold test done each day will be displayed on the graph.
6.5.3 Pacing Threshold Trend
This trend records the atrial and right/left ventricular pacing thresholds measured during SA/
CV sequences. A threshold sample is measured every 24 hours. The maximum trend duration is
approximately 240 days with a sampling interval of approximately 24 hours.
The pacing threshold sampled is always the most recent measured threshold. In other words, the
logged pacing threshold is unaffected by ACC or RVCC/LVCC algorithm failures or aborts.
PAGE 78
Page 87
Chapter 6 Statistics
Evia HF / HF-T Technical Manual
Figure 48: Pulse Amplitude Histogram
The Pulse amplitude histogram, shown in Figure 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.
Important note: In addition to each paced event being counted, Evia HF / HF-T will also count each
output during the capture control test.
6.5.4 Capture Control Status
The Capture Control Status displays the status, threshold last value (including time and date), current
pacing amplitude, and reason for ACC or RVCC/LVCC being disabled or suspended (if applicable).
Figure 49: Capture Control Status
The Capture Control Status in Figure 49 shows data related to Capture Control testing. The data
shown includes the current status, the last measured threshold, the date and time of the last
measurement and any note or comments related to capture control testing. Notes will display the
reasons that ACC or VCC was not completed. These reasons may include:
PAGE 79
Page 88
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
6.6.1 P- and R-wave Trends
Evia CRT-Ps periodically perform P- and RV/LV-wave amplitude measurements to be displayed later
as trend data. A P- and R-wave long-term trend of up to 240 days is available. After the initial timeframe
has elapsed, the rst data stored is overwritten with new data; therefore, the most recent data are
available for review.
Figure 50: P/R Wave Trend
The P/R wave trend graph shown in Figure 50 shows the sensing results for P- and R-wave
measurements. The graph collects daily data for up to 240 days and then overwrites the oldest
information.
Each sensed event is measured by the device and the average value over the 24-hour period is
displayed on the graph.
Note: Some data may not be displayed if the device is interrogated less than 24 hours after the
statistics are restarted.
6.6.2 Far-eld Histogram
The Far-eld Histogram provides information related to cross-talk following Vp and Vs events. The
range is < 30 ms to > 220 ms for each type of event. The display provides the percentage of far-eld
events at each value.
PAGE 80
Page 89
Chapter 6 Statistics
Evia HF / HF-T Technical Manual
Figure 51: Far-Field Histogram
The Far-eld 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.
The area in gray represents the programmed interval range of the far-eld protection parameter. Events
outside the programmed far-eld protection interval will be shown in the white portion of the graph.
6.6.3 Ap-Vs interval distribution curve
This graph provides information related to the amount of Vs response to atrial paced events. The
information is divided into 5 rate bins and provides the minimum, mean and maximum Ap-Vs intervals
for each rate bin. The programmed AV Delay is also shown.
The data is also displayed on a graph with the Y axis showing the range of programmable AV Delay
options and the X axis graph showing heart rate.
The number of successful AV hysteresis scans is provided on this graph.
Figure 52: Ap-Vs Interval Distribution
PAGE 81
Page 90
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. These averages are as follows:
• 60 bpm: rate range of 50 - 69 bpm
• 80 bpm: rate range of 70 - 89 bpm
• 100 bpm: rate range of 90 - 109 bpm
• 120 bpm: rate range of 110 - 129 bpm
• 140 bpm: rate range of 130 - 149 bpm
Each bin of data provides the median, minimum, and maximum Ap-Vs interval.
6.6.4 Av-Vs interval distribution curve
This graph provides information related to the amount of Vs response to atrial sensed events. The
information is divided into 5 rate bins and provides the minimum, mean and maximum Ap-Vs intervals
for each rate bin.
The data is also displayed on a graph with the Y axis showing the range of programmable AV Delay
options and the X axis graph showing heart rate.
The number of successful AV hysteresis scans is provided on this graph.
Figure 53: As-Vs Interval Distribution
The As-Vs interval distribution graph in Figure 53 shows the As-Vs interval data at different rates. The
As-Vs interval is displayed for various rate ranges, labeled by the average heart rate. These averages
are as follows:
• 60 bpm: rate range of 50 - 69 bpm
• 80 bpm: rate range of 70 - 89 bpm
• 100 bpm: rate range of 90 - 109 bpm
• 120 bpm: rate range of 110 - 129 bpm
• 140 bpm: rate range of 130 - 149 bpm
Each bin provides the median, minimum, and maximum As-Vs interval.
PAGE 82
Page 91
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. The graph shows the percentage of Vp suppression for each day.
Figure 54: Vp Suppression
The Vp Suppression information, shown in Figure 54, provides the number of Vs searches for Vp
Suppression, the number of success switches and the duration per day the algorithm is active.
6.7 Heart Failure Monitoring Statistics
6.7.1 Mean Heart Rate
The mean heart rate is calculated based on both ventricular sensed and paced events. All types of
events, including VES (PVC) shall be included in the calculation of the mean value. On a daily basis,
the device measures and stores the patient’s mean heart rate over a 24 hour period and has a value
range of 0 to 180 bpm. The daily value is stored for a period of 240 days. After 240 days, new daily
values shall replace the oldest daily values. The programmer presents the daily bpm-value in a trend
graph for the last 240 days.
6.7.2 Mean Heart Rate at Rest
On a daily basis, the Evia CRT-P measures and stores the patient’s resting heart rate (MHRR). Average
values are calculated over a dened period. The daily value is based on the smallest mean value in any
evaluation window over the resting period. The mean heart rate is calculated based on both ventricular
sensed and paced events. All types of events, including VES (PVC) shall be included in the calculation
of the mean value.
The MHRR value is measured during a programmed period, dened by a Rest Period Start Time and
a Rest Period Duration. The resting period shall be adjustable via the programmer. The MHRR has a
value range of 0 to 180 bpm. The daily value (MHRR) is stored for a period of 240 days. After 240 days,
new daily values replace the oldest daily values. The programmer presents the daily bpm-value in a
trend graph for the last 240 days.
PAGE 83
Page 92
Chapter 6 Statistics
Evia HF / HF-T Technical Manual
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).
6.7.4 Patient Activity
The patient’s activity is monitored based on the sensor indicated pacing rate in both, rate adaptive and
non-rate adaptive pacing modes. The Evia HF-T stores information about the patient’s activity level
based on the sensor indicated pacing rate on a daily basis. The device stores the time that the patient
is active for each 24-hour period. The time active is dened as the time where the sensor indicated
pacing rate is reached.
The sensor indicated pacing rate is the sensor rate above the sensor’s threshold. The cumulative daily
time when the sensor is active is stored in the device for a period of 240 days. After 240 days, new daily
values replace the oldest daily values.
6.7.5 Thoracic Impedance
The thoracic impedance is measured between the distal pacing lead tip of the RV lead and the
pacemaker housing. 8 measurements are done every hour and these measurements are then
averaged. The 24 measurements per day are then average are stored in the device and transmitted via
Home Monitoring. The Home Monitoring website then displays a trend of the daily average. The same
trend of daily TI averages is displayed on the programmer upon interrogation of the pacemaker. The
TI trend does not replace assessments that are part of standard of care for the clinical practice. The
clinical value of this feature has not been established for the management of patients.
Figure 55: Thoracic Impedance
Key points:
The heart-rate graph reports mean heart rate (indicated by “V” in the key) and resting heart rate
(indicated by “Rest” in the key).
PAGE 84
Page 93
Chapter 6 Statistics
Evia HF / HF-T Technical Manual
• Mean heart rate reports the average of the ventricular rate over a 24-hour period (based on Vs, Vp,
Vrs, and PVCs).
• The resting heart rate reports minimum ventricular heart rate during the programmed resting period
(default beginning at 2:00 AM with a 4-hour duration, programmable under the Diagnostics/HM
tab).
• The minimum ventricular heart rate is determined by taking 11-minute averages during the resting
period and reporting the lowest of those averages.
Variability is based on the P-P interval, and uses only intrinsic P-P intervals, not atrial paced events.
• Variability is calculated by taking the standard deviation of the 5-minute mean P-P intervals.
Patient activity is available in both rate adaptive and non-rate adaptive pacing modes.
• Data is displayed as the percent of the day (24 hour period) the patient is active.
• Patient activity is present when the device sees motion on the accelerometer.
• Activity is based on the currently programmed sensor threshold.
• If the mode is DDD, activity is measured using a mean sensor threshold.
• Not available in single-chamber devices.
Thoracic Impedance is measured from the distal tip to the pacemaker housing.
• 8 measurements per hour
• Measurements averaged to a single data point
• Thoracic impedance should NOT be used as a stand alone parameter to determine CHF
Variables such as COPD and hypovolemia may affect measurement values
NOTE:
Pocket and or lead revisions may affect the TI trend data. Therefore, the TI trend data should be
interpreted cautiously within 6-10 weeks of a revision.
6.8 IEGM Recordings
Evia HF / HF-T pulse generators can provide IEGM Snapshots, which are stored intracardiac events
based on programmable triggers for later display and review via the programmer screen. The
intracardiac events are represented on the programmer screen by event markers. Recordings may be
triggered by the following events:
• High atrial rates
• High ventricular rates
• 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.
By applying a magnet over the pulse generator for approximately 2 seconds, the current heart rhythm
will be instantly recorded. However, Evia HF-T commits the recording to memory only when the magnet
has been removed.
The following intracardiac events are stored with each IEGM:
• Type of IEGM snapshot
• Date and time of IEGM snapshot
• Duration of episode (for Mode Switch and High ventricular rates only)
PAGE 85
Page 94
Chapter 6 Statistics
Evia HF / HF-T Technical Manual
• Maximum ventricular rate during episode
• Atrial IEGM markers (i.e., atrial paced events, atrial sensed events, atrial unused or refractory
sensed events)
• Ventricular IEGM markers (i.e., ventricular paced events, ventricular sensed events, ventricular
unused or refractory sensed events)
• Atrial IEGM
• Right/Left Ventricular IEGMs
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.
An IEGM is not recorded when the programming wand is placed over the pulse generator. However, a
patient triggered IEGM will be recorded when a magnet is placed over the pulse generator with normal
transtelephonic monitoring.
PAGE 86
Page 95
Chapter 7 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. Table 19 shows the Safe Program settings for
Evia CRT-P devices.
Parameter Setting
Mode VVI
Pacing Rate 70 ppm
Amplitude 4.8 V (Right/Left ventricle)
Pulse Width 1.0 ms (Right/Left ventricle
Sensitivity 2.5 mV
Ventricular Refractory
Period
Pacing Polarity Unipolar
Single Chamber Hysteresis OFF
Table 19: Safe Program Settings
300 ms (RV)
200 ms LV
7.2 Magnet Effect
7.2.1 Automatic Magnet Effect
After magnet application the pulse generator paces at 90 ppm for 10 cycles asynchronously. Thereafter,
the pulse generator paces synchronously at the programmed basic rate. During asynchronous pacing,
the AV interval is reduced to 100 ms.
7.2.2 Asynchronous Magnet Effect
When programmed to asynchronous operation, magnet application results in asynchronous pacing.
The pulse generator paces asynchronously at 90 ppm as long as the magnet is over the pulse
generator. Upon magnet removal, the current basic interval is completed before the pulse generator
reverts to its original operating mode.
If the magnet effect is set to asynchronous, the AV delay is reduced to 100 ms (or the programmed AV
delay, whichever is shorter). Shortening of the AV delay to 100 ms during asynchronous AV sequential
stimulation is provided to avoid ventricular fusion beats in the presence of intact AV conduction. This
allows efcient diagnosis of ventricular capture or failure to capture.
7.2.3 Synchronous Magnet Effect
If the magnet effect is programmed to synchronous operation, magnet application does not affect timing
and sensing behavior of the pulse generator. Synchronous operation is of particular importance during
follow-up, if sensing and inhibition functions are desired during magnet application.
Trend monitor and event counter operation is interrupted during any magnet application.
PAGE 87
Page 96
Chapter 7 Other Functions/Features
Evia HF / HF-T Technical Manual
7.3 Temporary Programming
CAUTION
OFF Mode – Use of the OFF mode should be avoided in pacemaker
dependent patients. The OFF mode can be transmitted as a
temporary program only to permit evaluation of the patient’s
spontaneous rhythm.
A temporary program is a pacing program which remains activated while the programming head is
positioned over the pulse generator. Upon removal of the programming head (at least 15 cm away
from the pulse generator), the temporary program will be automatically deactivated and the permanent
program will again be in effect.
Generally, every pacing program displayed on the programmer screen may be transmitted as a
temporary program by pressing the key designated on the programmer keyboard. With few exceptions,
this also applies to pacing programs containing a parameter conict, which cannot be programmed
as permanent programs. Temporary programming facilitates follow-up and enhances patient safety.
Test programs affecting patient safety, like pacing threshold measurements in a pacemaker-dependent
patient, should be activated as a temporary program only.
When interrogating the pulse generator, the permanent program will always be displayed and
documented, even though a temporary program was activated during the interrogation.
During temporary program activation, the rate adaptation, trend monitor, and the event counter are
always inactive.
7.4 Patient Data Memory
Individual patient data can be stored in the pulse generator’s memory. The stored data is automatically
displayed upon each interrogation. The amount of data stored is determined by the software version
being used. The patient data memory contains the following data categories:
• Patient ID (Code)
• Patient Name
• Date of Birth
• Gender
• Symptom
• Etiology
• ECG Indication
• Physician
• Implantation Date
• Lead Polarity (A / RV / LV)
• Lead Mode
• Lead Serial Number
• Lead Manufacturer
• Lead Position
• NYHA Class
• LVEF
• Hospital
• City
WARNING
Unipolar/Bipolar – Evia HF / HF-T can be used with either unipolar
or bipolar IS-1 leads.
PAGE 88
If the pacing or sensing function is to be programmed to bipolar,
it must be veried that bipolar leads have been implanted in that
chamber. If either of the leads is unipolar, unipolar sensing and
pacing functions must be programmed in that chamber. Failure to
program the appropriate lead conguration could result in entrance
and/or exit block.
Page 97
Chapter 7 Other Functions/Features
Evia HF / HF-T Technical Manual
Symptom, etiology and ECG indication are specied using the European PASSPORT code system. The
PASSPORT code is an identication system of two character codes that represent specic conditions. A
listing of the codes available with denitions is displayed on the screen of the programmer when patient
data is selected. When the patient data screen is entered symptom, etiology, or ECG indication may be
entered, and can be accessed following interrogation to check code denition.
When the patient data screen is printed, the date of last follow-up is automatically given on the print-out.
7.5 Position Indicator
The position indicator facilitates positioning of the programmer head. The programmer optically and
acoustically indicates whether the programmer head is in communication with the pulse generator.
7.6 Pacing When Exposed to Interference
CAUTION
EMI – Computerized systems are subject to EMI or “noise”. In the
presence of such interference, telemetry communication may be
interrupted and prevent programming.
A sensed event occurring during the interference interval will continuously reset that interval for the
corresponding chamber without resetting the basic interval. Depending upon whether the interference
(electromagnetic interference, muscle potentials, etc.) is detected by the atrial and/or ventricular
channel, atrial and/or ventricular asynchronous pacing at the programmed timing intervals will result for
the duration of the interference. The interference interval has a duration of 51 ms.
Depending on the programmed pacing mode and the channel in which electromagnetic interference
(EMI) occurs, Table 20 details the resulting pacing modes for the duration of exposure to EMI.
MODE EMI6 (A) EMI6 (V) EMI6 (A+V)
DDD(R)- ADI(R)
DDD-CLS
VVI-CLS
DDD(R)
DDI(R)
DVI(R)
VDD(R)
VVI(R)
AAI(R)
DVD(R)
DVDR
---
DVD(R)
DVI(R)
---
VVI(R)
---
AOO(R)
DAD(R)
DADR
VOOR
DAD(R)
DAI(R)
DOO(R)
VAT(R)
VOO(R)
---
DOO(R)
DOOR
---
DOO(R)
DOO(R)
---
VOO(R)
---
---
DDT
VDI
VVT
AAT
6 EMI = Electromagnetic Interference
VVT
VVT
---
AOO
Table 20: Response to EMI
VAT
VOO
VOO
---
VOO
VOO
---
---
PAGE 89
Page 98
Chapter 7 Product Storage and Handling
Evia HF / HF-T Technical Manual
PAGE 90
Page 99
Chapter 8 Product Storage and Handling
Evia HF / HF-T Technical Manual
8. Product Storage and Handling
8.1 Sterilization and Storage
The pulse generator is shipped in a cardboard box, equipped with a quality control seal and product
information label. The label contains the model specications, technical data, serial number, expiration
date, and sterilization and storage information of the pulse generator. The box contains a double
container with the pulse generator and product documentation.
The pulse generator and its accessories have been sealed in a container and gas sterilized with
ethylene oxide. To assure sterility, the container should be checked for integrity prior to opening. If a
breach of sterility is suspected, return the pulse generator to BIOTRONIK.
CAUTION
Storage (temperature) – Recommended storage temperature range
is -10° to 45°C (14°-113°F). Exposure to temperatures outside this
range may result in pulse generator malfunction.
Handling – Do not drop. If an unpackaged pulse generator is
dropped onto a hard surface, return it to BIOTRONIK.
CAUTION
FOR SINGLE USE ONLY – Do not resterilize the pulse generator or
accessories packaged with the pulse generator, they are intended for
one-time use.
Device Packaging – Do not use the device if the packaging is wet,
punctured, opened or damaged because the integrity of the sterile
packaging may be compromised. Return the device to BIOTRONIK.
Storage (magnets) – Store the device in a clean area, away from
magnets, kits containing magnets, and sources of electromagnetic
interference (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
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 eld.
Peel off the sealing paper of the outer
container as indicated by the arrow.
Take out the inner sterile container by the
gripping tab and open it by peeling the
sealing paper as indicated by the arrow.
A torque wrench is included within the blister package of each Evia CRT-P.
8.3 Pulse Generator Orientation
The pulse generator may be used in either the left or right side pectoral implants. Either side of the
pulse generator can face the skin to facilitate excess lead wrap.
PAGE 92
Loading...