BIOTRONIK Evia DR-T User 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................................................................27
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
7.11.1PMT Management ...............................................84
7.11.2PMT Protection ....................................................85
7.12 Adjustment of the PMT Protection Window ..............86
7.13 Ventricular Capture Control (VCC)............................87
7.13.1Feature Description..............................................87
7.13.2Ventricular Capture Control Programming...........96
7.14 Program Consult®......................................................97
7.15 Home Monitoring (Evia DR-T).................................101
7.15.1Transmission of Information...............................102
7.15.2Patient Device .................................................... 102
7.15.3Transmitting Data...............................................103
7.15.4Types of Report Transmissions .........................105
7.15.5Description of Transmitted Data ........................106
8. Statistics.......................................................................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...............................................123
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
12.6.1Description .........................................................139
12.6.2Burst Stimulation ................................................140
12.6.3Programmed Stimulation ...................................140
12.6.4Back up Pacing ..................................................140
12.6.5NIPS Safety Features ........................................141
12.7 Optimizing Rate Adaptation.....................................142
12.7.1Rate/Sensor Trend.............................................142
12.7.2Adjusting the Sensor Gain .................................143
12.7.3Adjusting 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
15.2.1Rate Adaptation .................................................157
15.2.2Ventricular Capture Control (VCC) ....................158
15.2.3Home Monitoring Parameters ............................158
15.2.4Additional Functions...........................................160
15.2.5NIPS 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 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 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 IS-
1 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 5841-
3:1992(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.