BIOTRONIK Evia HF Manuel utilisateur

Cardiac Rhythm Management

Heart Failure Therapy

Evia HF / HF-T

Techncal Manual

Evia HF / HF-T

Implantable Pulse Generators

Evia HF / HF-T

X-Ray identication

Radiopaque Identication

A radiopaque identication code is visible on standard x-ray, and identies the pulse generator:

Evia HF / HF-T SF

CAUTION

Because of the numerous available 3.2-mm congurations (e.g., the

IS-1 and VS-1 standards), lead/pulse generator compatibility should

be conrmed 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).

PAGE i

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 Specic 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

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Evia HF / HF-T Technical Manual

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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 Specic 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 Specic 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

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Evia HF / HF-T Technical Manual

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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

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Evia HF / HF-T Technical Manual

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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

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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 .........................................................................................................................115

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 Specications ................................................................................................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).

Chapter Table of Contents

Evia HF / HF-T Technical Manual

PAGE vi

Chapter 1 Device Description

Evia HF / HF-T Technical Manual

PAGE 1

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-specic

pacing rates. Specically, 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 specic 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]).

Chapter 1 Device Description

Evia HF / HF-T Technical Manual

PAGE 2

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

Evia HF-T

Triple chamber, rate-adaptive, unipolar/

bipolar pacing CRT-P with Home

Monitoring

Throughout this manual, specic 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.

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