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]).