BIOTRONIK Evia DR-T, Evia DR, Evia SR, Evia SR-T Technical Manual
Evia
Family of Implantable Pulse Generators
Technical Manual
Evia
Implantable Pulse Generators
Evia DR
X-Ray identification
Evia DR-T
X-Ray identification
Radiopaque Identification
A radiopaque identification code is visible on standard x-ray, and
identifies the pulse generator:
Evia DR, DR-T, SR, and SR-T
SF
CAUTION
Because of the numerous available 3.2-mm configurations
(e.g., the IS-1 and VS-1 standards), lead/pulse generator
compatibility should be confirmed 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 fit.
[Reference ISO 5841-3:1992(E)].
CAUTION
Federal (U.S.A.) law restricts this device to sale by or on the
order of, a physician (or properly licensed practitioner).
©2009 BIOTRONIK, Inc., all rights reserved.
Evia Technical Manual i
Contents
1. Device Description .................................... ...................... 1
2. Indications ........................................................................ 4
3. Contraindications ............................................................ 6
4. Warnings and Precautions ............................................. 8
4.1 Medical Therapy .......................................................... 8
4.2 Storage and Sterilization ........................................... 10
4.3 Lead Connection and Evaluation .............................. 10
4.4 Programming and Operation ..................................... 12
4.5 Home Monitoring ....................................................... 14
4.6 Electromagnetic Interference (EMI) .......................... 15
4.6.1 Home and Occupational Environments ............... 16
4.6.2 Cellular Phones .................................................... 17
4.6.3 Hospital and Medical Environments .................... 18
4.7 Pulse Generator Explant and Disposal ..................... 19
5. Adverse Events .............................................................. 21
5.1 Observed Adverse Events ........................ ................. 21
5.1.1 Dromos DR Clinical Study ................................... 21
5.1.2 PACC Clinical Study ............................................ 23
5.1.3 Inos2+ CLS Clinical Study ................................... 24
5.2 Potential Adverse Events .......................................... 26
6. Clinical Study ................................................................. 27
6.1 Dromos DR ................................. ............................... 2 7
6.2 Ventricular Capture Control ....................................... 28
6.2.1 Primary Objectives ............................................... 29
6.2.2 Methods ............................................................... 29
6.2.3 Results ................................................................. 29
6.2.4 Clinical Study Conclusions ............ ....................... 34
6.3 Closed Loop Stimulation (CLS) ................................. 35
6.3.1 Protos DR/CLS Response to Mental Stress ........ 35
6.3.2 Protos DR CLS with AxVx .................................... 38
6.3.3 Inos2+ CLS ............................................................ 41
6.4 TRUST Clinical Study ................................................ 44
6.4.1 Study Overview .................................................... 44
6.4.2 Methods ............................................................... 45
6.4.3 Summary of Clinical Results ................................ 47
ii Evia Technical Manual
6.4.4 Conclusions ............... ............................... ............ 51
7. Programmable Parameters ........................................... 53
7.1 Pacing Modes .................................................. .......... 53
7.1.1 Motion Based Rate-Adaptive Modes ................... 53
7.1.2 CLS Modes .......................................................... 53
7.1.3 Non-Rate-Adaptive Modes ................................... 54
7.1.4 Mode Switching .................................................... 55
7.1.5 Pacing Modes with Triggered Response ............. 56
7.2 Rate Related Functions ............................................. 57
7.2.1 Basic Rate ............................................................ 57
7.2.2 Rate Hysteresis .................................................... 58
7.2.3 Scan Hysteresis ................................................... 59
7.2.4 Repetitive Hysteresis ........................................... 60
7.2.5 Night Mode ........................................................... 61
7.2.6 Rate Fading .... .............................. ........................ 62
7.3 Pulse Specific Features ............................................. 63
7.3.1 Pulse Amplitude ................................................... 63
7.3.2 Pulse Width .......................................................... 64
7.4 Automatic Sensitivity Control (ASC) .......................... 64
7.5 Timing Features ........................................................ 65
7.5.1 Refractory Periods ............................................... 65
7.5.2 PVARP ................................................................. 65
7.5.3 AV Delay .............................................................. 67
7.5.4 Ventricular Blanking Period .................................. 71
7.5.5 Atrial Blanking Period ........................................... 72
7.5.6 Far-Field Protection ............................................. 72
7.5.7 Safety AV Delay ................................................... 72
7.5.8 Upper Rate and UTR Response .......................... 73
7.6 Lead Polarity ............................................................. 73
7.7 Parameters for Rate-Adaptive Pacing ...................... 74
7.7.1 Sensor Gain ......................................................... 75
7.7.2 Automatic Sensor Gain ........................................ 76
7.7.3 Sensor Threshold ................................................. 77
7.7.4 Rate Increase ....................................................... 78
7.7.5 Maximum Sensor Rate ........................................ 79
7.7.6 Maximum Closed Loop Rate ................................ 79
7.7.7 Rate Decrease ..................................................... 80
7.8 Management of Specific Scenarios ........................... 81
7.8.1 2:1 Lock-In Management ..................................... 81
7.9 Atrial Upper Rate ....................................................... 82
7.10 Atrial Overdrive Pacing (Overdrive Mode) ................ 83
Evia Technical Manual iii
7.11 Management of Specific Scenarios ........................... 84
7.11.1 PMT Management ............................................... 84
7.11.2 PMT Protection .................................................... 85
7.12 Adjustment of the PMT Protection Window .............. 86
7.13 Ventricular Capture Control (VCC) ............................ 87
7.13.1 Feature Description .................... .......................... 87
7.13.2 Ventricular Capture Control Programming........... 96
7.14 Program Consult® ..................................... ................. 97
7.15 Home Monitoring (Evia DR-T) ................................. 101
7.15.1 Transmission of Information ............................... 102
7.15.2 Patient Device .................................................... 102
7.15.3 Transmitting Data ............................................... 103
7.15.4 Types of Report Transmissions ......................... 105
7.15.5 Description of Transmitted Data ........................ 106
8. St atistics ....................................................................... 109
8.1 Statistics Overview .................................................. 109
8.1.1 Timing ................................................................ 109
8.1.2 Atrial Arrhythmia .......................................... ....... 109
8.1.3 Sensor ................................ ................................ 109
8.1.4 Sensing .............................................................. 110
8.1.5 Ventricular Arrhythmia ....................................... 110
8.1.6 Pacing ................................................................ 110
8.1.7 General Statistical Information ........................... 110
8.2 Timing Statistics ...................................................... 111
8.2.1 Event Counter .................................................... 111
8.2.2 Event Counter .................................................... 111
8.2.3 Event Episodes .................................................. 112
8.2.4 Rate Trend 24 Hours ......................................... 112
8.2.5 Rate Trend 240 Days ......................................... 112
8.2.6 Atrial and Ventricular Rate Histogram ............... 113
8.3 Arrhythmia Statistics ................................................ 113
8.3.1 Atrial Burden ...................................................... 113
8.3.2 Time of occurrence ............................................ 113
8.3.3 Mode Switching .................................................. 113
8.3.4 Ventricular Arrhythmia ....................................... 114
8.4 Sensor Statistics ...................................................... 114
8.4.1 Sensor Histogram .............................................. 114
8.4.2 Activity Report .................................................... 115
8.5 Pacing Statistics ...................................................... 115
8.5.1 Ventricular Pacing Amplitude Histogram ........... 116
8.5.2 V Pacing Threshold Trend ................................. 116
iv Evia Technical Manual
8.5.3 Capture Control Status ...................................... 117
8.6 Sensing Statistics .................................................... 117
8.7 IEGM Snapshots ..................................................... 118
9. Other Functions/Features ........................................... 121
9.1 Safe Program Settings ............................................ 121
9.2 Magnet Effect .......................................................... 121
9.3 Temporary Programming ......................................... 122
9.4 Patient Data Memory .................... ........................... 1 23
9.5 Position Indicator .................. .............................. ..... 124
9.6 Pacing When Exposed to Interference ................... 125
10. Product Storage and Handling ................................... 126
10.1 Sterilization and Storage ......................................... 126
10.2 Opening the Sterile Container ................................. 127
10.3 Pulse Generator Orientation ................................... 128
11. Lead Connection .......................................................... 130
11. 1 Auto Initialization ..................................................... 133
12. Follow-up Procedures ................................................. 136
12.1 General Considerations .......................................... 136
12.2 Real-time IEGM Transmission ................................ 137
12.3 Threshold Test ......................................................... 137
12.4 P/R Measurement ................................................... 138
12.5 Testing for Retrograde Conduction ......................... 139
12.6 Non-Invasive Programmed Stimulation (NIPS) ....... 139
12.6.1 Description ......................................................... 139
12.6.2 Burst Stimulation ................................................ 140
12.6.3 Programmed Stimulation ................................... 140
12.6.4 Back up Pacing .................................................. 140
12.6.5 NIPS Safety Features ........................................ 141
12.7 Optimizing Rate Adaptation ..................................... 142
12.7.1 Rate/Sensor Trend ............................................. 142
12.7.2 Adjusting the Sensor Gain ................................. 143
12.7.3 Adjusting the Sensor Threshold ......................... 143
13. Elective Replacement Indication (ERI) ...................... 145
14. Explantation ................................................................. 149
14.1 Common Reasons to Explant a Pulse Generator ... 149
15. Technical Data .............................................................. 153
15.1 Modes .................. ................... .................... ............. 153
Evia Technical Manual v
15.2 Pulse- and Control Parameters ............................... 154
15.2.1 Rate Adaptation ................................................. 157
15.2.2 Ventricular Capture Control (VCC) .................... 158
15.2.3 Home Monitoring Parameters ............................ 158
15.2.4 Additional Functions ........................................... 160
15.2.5 NIPS Specifications ........................................... 161
15.3 Programmer ............................................................ 161
15.4 Materials in Contact with Human Tissue ................. 161
15.5 Electrical Data/Battery ............................................. 161
15.6 Mechanical Data ........... ................................. .......... 163
16. Order Information ........................................................ 164
Appendix A ........................................................................ 166
Appendix B ........................................................................ 172
CAUTION
Federal (U.S.A.) law restricts this device to sale by, or on the
order of, a physician (or properly licensed practitioner).
vi Evia Technical Manual
Evia Technical Manual 1
1. Device Description
Evia is a multi-programmable, dual chamber pulse generator
with rate-adaptive pacing. The Evia family of pulse generators 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-specific pacing rates. Specifically, 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
specific to the patient’s individual physiologic demands due to
exercise and acute mental stress.
For standard motion-based rate-adaptation, the Evia 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 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. Refer to Section 6.4 for
details regarding the study design and results. With the TRUST
study, BIOTRONIK was able to show the following with regards
to Home Monitoring:
2 Evia Technical Manual
• BIOTRONIK Home Monitoring information may be used as a
replacement for device interrogation during in-office followup 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 provides single and dual 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 fit [Reference ISO 5841-3:1992]).
Evia Technical Manual 3
Evia is designed to meet all indications for bradycardia therapy
as exhibited in a wide variety of patients. The family is
comprised of four pulse generators that are designed to handle a
multitude of situations. The four pulse generators include:
Evia DR
Dual chamber, rate-adaptive,
unipolar/bipolar
Evia DR-T
Dual chamber, rate-adaptive,
unipolar/bipolar, with Home Monitoring
Evia SR
Single chamber, rate-adaptive,
unipolar/bipolar
Evia SR-T
Single chamber, rate-adaptive,
unipolar/bipolar, with Home Monitoring
Throughout this manual, specific feature and function
descriptions may only be applicable to certain pulse generators
of the Evia family. If specified as dual chamber configurations,
the descriptions are specifically referring to Evia DR and
Evia DR-T. If specified as single chamber configurations, the
descriptions are specifically referring to Evia SR and Evia SR-T.
4 Evia Technical Manual
2. Indications
Rate-adaptive pacing with Evia pulse generators is indicated for
patients exhibiting chronotropic incompetence and who would
benefit from increased pacing rates concurrent with physical
activity.
Generally accepted indications for long-term cardiac pacing
include, but are not limited to: sick sinus syndrome (i.e.
bradycardia-tachycardia syndrome, sinus arrest, sinus
bradycardia), sino-atrial (SA) block, second- and third- degree
AV block, and carotid sinus syndrome.
Patients who demonstrate hemodynamic benefit through
maintenance of AV synchrony should be considered for one of
the dual chamber or atrial pacing modes. Dual chamber modes
are specifically indicated for treatment of conduction disorders
that require both restoration of rate and AV synchrony such as
AV nodal disease, diminished cardiac output or congestive heart
failure associated with conduction disturbances, and
tachyarrhythmias that are suppressed by chronic pacing.
Evia Technical Manual 5
6 Evia Technical Manual
3. Contraindications
Use of Evia pulse generators 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-specific contraindications,
please refer to Appendix A
of this manual.
Evia Technical Manual 7
8 Evia 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.
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 confirmed 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.
Evia Technical Manual 9
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.
Defibrillation – The following precautions are recommended to
minimize the inherent risk of pulse generator operation being
adversely affected by defibrillation:
• 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.
Electrocautery – Electrocautery should never be performed
within 15 cm (6 inches) of an implanted pulse generator or lead
because of the danger of introducing fibrillatory 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.
10 Evia Technical Manual
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 5° to 55°C (41°-131°F). Exposure to temperatures
outside this range may result in pulse generator malfunction (see
Section
10.1).
Handling – Do not drop. If an unpackaged pulse generator is
dropped onto a hard surface, return it to BIOTRONIK (see
Section 10.1
).
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 IS1 compatible connectors. There are no requirements specific to
the atrial lead. It is required to use a low polarization ventricular
lead for activation of Ventricular Capture Control.
Evia Technical Manual 11
Ventricular Capture Control - The Ventricular Capture Control
feature should be programmed OFF before lead connection. The
feature is designed to measure thresholds and will automatically
reprogram the ventricular pulse amplitude. In the absence of a
connected lead, the feature will not be able to perform these
measurements and set the output to an appropriate value.
Lead Check – The Evia pulse generators have an automatic
lead check feature which may switch from bipolar to unipolar
pacing and sensing without warning. This situation may be
inappropriate for patients with an Implantable Cardioverter
Defibrillator (ICD).
Lead/pulse Generator Compatibility – Because of the
numerous available 3.2-mm configurations (e.g., the IS-1 and
VS-1 standards), lead/pulse generator compatibility should be
confirmed 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 fit. [Reference ISO 58413:1992(E)].
Lead Configuration – Lead configuration determines proper
programming of the pulse generator. Pacing will not occur with a
unipolar lead if the lead configuration is programmed to bipolar.
Setscrew Adjustment – Back-off the setscrew(s) prior to
insertion of lead connector(s) as failure to do so may result in
damage to the lead(s), and/or difficulty connecting lead(s).
Cross Threading Setscrew(s) – To prevent cross threading
the setscrew(s), do not back the setscrew(s) completely out of
the threaded hole. 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.
12 Evia Technical Manual
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 conflicting evidence regarding the potential
benefit 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 the SA/CV sequence is not successful,
program the VCC to OFF and program the pacing pulse
amplitude manually.
NIPS - Life threatening ventricular arrhythmias can be induced
by stimulation in the atrium. Ensure that an external cardiac
defibrillator 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 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 verified 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 configuration
could result in entrance and/or exit block.
Programmers – Use only appropriate BIOTRONIK
programmers equipped with appropriate software to program
Evia pulse generators. 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.
Evia Technical Manual 13
Pacing thresholds – When decreasing programmed output
(pulse amplitude and/or pulse width), the pacing threshold must
first 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 Modifications – 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.
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 filter 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.
14 Evia Technical Manual
Muscle or Nerve Stimulation – Inappropriate muscle or nerve
stimulation may occur with unipolar pacing when using a noncoated pulse generator.
CLS Rate-Adaptation – Under certain circumstances (e.g., EMI,
lead dislodgment), the Evia 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
Evia Technical Manual 15
• 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 DR-T pulse generator are provided in
Section 4.6
. Sources of EMI including cellular telephones,
electronic article surveillance systems, and others are discussed
therein.
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 sufficient 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
significantly reduce susceptibility to electromagnetic interference
(EMI). However, due to the variety and complexity of sources
creating interference, there is no absolute protection against
EMI. 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.
16 Evia Technical Manual
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 field. 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 amplifiers, or highpower 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.
Evia Technical Manual 17
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.
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.
18 Evia Technical Manual
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 Hospi tal and Medical Environments
Electrosurgical Cautery – Electrosurgical cautery could induce
ventricular arrhythmias and/or fibrillation, 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 Defibrillation – External defibrillation may damage the
pulse generator. Attempt to minimize current flowing 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.
Evia Technical Manual 19
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 14
).
Explanted Devices – Return all explanted devices to
BIOTRONIK.
20 Evia Technical Manual
Evia Technical Manual 21
5. Adverse Events
NOTE:
The Evia family of pulse generators is a successor to the
BIOTRONIK’s Dromos, Philos, Inos, Protos, and Cylos
families of pulse generators. Therefore, data from the
clinical studies of these earlier generations are used to
support the safety and efficacy of the Evia family of pulse
generators.
5.1 Observed Adverse Events
5.1.1 Dromos DR Clinical Study
The Dromos DR Clinical Study involved 273 patients with
cumulative implant duration of 1418 months (mean implant
duration 5.2 months). Eleven patients died during the course of
the trial; none of the deaths was judged to be device-related.
One Dromos DR pulse generator was explanted during the trial,
secondary to infection.
Table 1
reports the adverse events (AE) on a per patient and a
per patient-month basis. The last column gives the expected
time (in months) between events; i.e., the reciprocal of the
AE/patient-month rate.
22 Evia Technical Manual
Ta bl e 1: Adverse Events Reported in > 1 Patient
Category
# pts
(n-273)
% of
patients
# of
AEs
AE/pt-
mo
(n-1418)
Pt-mos
between
AEs
Observations†
(total)
79* 28.9% 86 0.0606 16
Atrial Loss of
Sensing
10 3.7% 10 0.0071 142
Atrial Loss of
Capture
8 2.9% 8 0.0056 177
Pacemaker
Mediated
Tachycardia
11 4.0% 12 0.0085 118
Premature AV
Stimulation
4 1.5% 4 0.0028 355
Arrhythmias 34 12.5% 36 0.0254 39
Muscle/Diaphragm
atic Stimulation
3 1.1% 3 0.0021 473
Unexplained
Syncope
3 1.1% 3 0.0021 473
Complications‡
(total)
14* 5.1% 14 0.0099 101
Atrial Lead
Dislodgment
6 2.2% 6 0.0042 236
Ventricular Lead
Dislodgment
4 1.5% 4 0.0028 355
All Dromos DR Patients (N-273), Number and % of Patients, Events/Patient Mo.,
and Pt-Mos. between Events
†
Observations are adverse events, which are correctable by non-invasive
measures, e.g., reprogramming.
*
Not included in the Table are 6 observations and 4 complications each having
only one occurrence.
‡
Complications are adverse events requiring invasive measures to correct,
e.g., surgical intervention.
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