Medtronic 7288 Reference Guide

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INTRINSIC™/INTRINSIC
30
7288/7287
Dual Chamber Implantable Cardioverter Defibrillator (VVE-DDDR)
Reference Manual
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INTRINSIC™/INTRINSIC
30
7288/7287
Reference Manual
A guide to the operation and programming of the Intrinsic Model 7288 and Intrinsic 30 Model 7287 Dual Chamber Implantable Cardioverter Defibrillators
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The following are trademarks of Medtronic:
Active Can, Cardiac Compass, Checklist, Flashback, Intrinsic, Leadless ECG, MVP, Marker Channel, Medtronic, Medtronic CareLink, PR Logic, Patient Alert, Quick Look, QuickLink
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Table of Contents
Introduction 11
Part I Quick overview 15
1 Quick reference 17
1.1 New to Intrinsic 18
1.2 Physical characteristics 18
1.3 Magnet application 20
1.4 Longevity projections 21
1.5 Replacement indicators 23
1.6 Typical charge times 23
1.7 High voltage therapy energy 24
1.8 Stored data and diagnostics 26
2 The Intrinsic system 29
2.1 System overview 30
2.2 Indications and usage 33
2.3 Contraindications 33
2.4 Patient screening 33
3 Emergency therapy 35
3.1 Delivering emergency therapies 36
3.2 Delivering an emergency defibrillation therapy 37
3.3 Delivering an emergency cardioversion therapy 38
3.4 Delivering emergency fixed burst pacing 39
3.5 Enabling emergency VVI pacing 40
Part II Device implant and patient follow-up
procedures 43
4 Implanting the device 45
4.1 Overview 46
4.2 Preparing for an implant 46
4.3 Replacing a device 48
4.4 Positioning the leads 49
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Table of Contents
Part III Configuring the device for the patient 67
4.5 Testing sensing and pacing thresholds 51
4.6 Connecting the leads to the device 52
4.7 Testing defibrillation operation and effectiveness 54
4.8 Positioning and securing the device 58
4.9 Completing the implant procedure 58
5 Conducting a patient follow-up session 61
5.1 Patient follow-up guidelines 62
5.2 Verifying the status of the implanted system 62
5.3 Verifying accurate detection and appropriate therapy 63
5.4 Verifying effective bradycardia pacing 64
6 Detecting tachyarrhythmias 69
6.1 Detection overview 70
6.2 Setting up sensing 73
6.3 Detecting VF episodes 78
6.4 Detecting VT episodes 81
6.5 Detecting FVT episodes 87
6.6 Detecting tachyarrhythmia episodes with Combined Count 92
6.7 Monitoring episodes for termination or redetection 94
6.8 Enhancing detection with PR Logic criteria 98
6.9 Enhancing VT detection with the Stability criterion 106
6.10 Detecting double tachycardias 108
6.11 Detecting prolonged tachyarrhythmias with High Rate Timeout 109
7 Treating tachyarrhythmia episodes 113
7.1 Treating VF with defibrillation 114
7.2 Treating VT and FVT with antitachycardia pacing 123
7.3 Treating VT and FVT with cardioversion 133
7.4 Optimizing therapy with Smart Mode and Progressive Episode Therapies 141
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Table of Contents
8 Treating bradycardia 147
8.1 Providing basic pacing therapy 148
8.2 Dual chamber pacing 152
8.3 Single chamber pacing 162
8.4 MVP (Managed Ventricular Pacing) 165
8.5 Enhancing pacing for optimal cardiac output 170
8.6 Adjusting the pacing rate with Mode Switch 184
8.7 Preventing competitive atrial pacing 186
8.8 Detecting and preventing pacemaker-mediated tachycardia 192
8.9 Providing Ventricular Safety Pacing 196
8.10 Providing pacing after high voltage therapies 200
9 Optimizing charge time and device longevity 203
9.1 Optimizing charge time 204
9.2 Optimizing device longevity 207
Part IV Evaluating and managing patient treatment 209
7
10 Using the programmer 211
10.1 Setting up and using the programmer 212
10.2 Display screen features 213
10.3 Viewing and programming device parameters 218
10.4 Starting and ending patient sessions 222
10.5 Viewing live waveform traces 225
10.6 Recording live waveform strips 232
10.7 Saving and retrieving device data 234
10.8 Printing reports 238
11 Using system evaluation tools 245
11.1 A summary of system evaluation tools 246
11.2 Taking a quick look at device activity 247
11.3 Using the Patient Alert feature 249
11.4 Streamlining follow-ups with Checklist 256
12 Setting up and viewing collected data 261
12.1 A summary of data collection 262
12.2 Setting up data collection 263
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Table of Contents
12.3 Collecting lead performance data 267
12.4 Viewing the episode and therapy efficacy counters 269
12.5 Viewing episode data 272
12.6 Viewing Flashback Memory 280
12.7 Viewing battery and lead status data 281
12.8 Viewing lead performance trends 283
12.9 Using Cardiac Compass to view long ter m clinical trends 285
12.10 Viewing and entering patient information 292
12.11 Automatic device status monitoring 295
13 Testing the system 297
13.1 Testing overview 298
13.2 Evaluating the underlying rhythm 298
13.3 Measuring pacing thresholds 299
13.4 Measuring lead impedance 302
13.5 Measuring EGM amplitude 303
13.6 Testing the device capacitors 305
14 Conducting Electrophysiologic Studies 307
14.1 EP Study overview 308
14.2 Inducing VF with T-Shock 309
14.3 Inducing VF with 50 Hz Burst 313
14.4 Inducing an arrhythmia with Manual Burst 315
14.5 Inducing an arrhythmia with PES 318
14.6 Delivering a manual therapy 320
15 Solving system problems 325
15.1 Overview 326
15.2 Solving sensing problems 326
15.3 Solving tachyarrhythmia detection problems 328
15.4 Solving tachyarrhythmia therapy problems 329
15.5 Solving bradycardia pacing problems 330
15.6 Responding to device status indicators 331
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Appendices 333
A Warnings and precautions 335
A.1 General warnings 336
A.2 Storage and handling 336
A.3 Resterilization 337
A.4 Device operation 338
A.5 Lead evaluation and lead connection 339
A.6 Follow-up testing 340
A.7 Explant and disposal 340
A.8 Medical therapy hazards 341
A.9 Home and occupational environments 343
B Device parameters 345
B.1 Emergency settings 346
B.2 Detection parameters 347
B.3 Therapy parameters 348
B.4 Pacing parameters 350
B.5 System maintenance parameters 353
B.6 Data collection parameters 354
B.7 System test and EP study parameters 355
B.8 Fixed parameters 357
B.9 Patient information parameters 359
B.10 Programmer symbols 360
B.11 Parameter interlocks 361
Table of Contents
9
Glossary 363
Index 371
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Introduction
About this manual
Introduction
This manual describes the operation and intended use of the Intrinsic Model 7288 and Intrinsic 30 Model 7287 systems.
In these systems, both devices provide ventricular tachyarrhythmia detection and therapy and a full range of dual-chamber bradycardia pacing modes and associated features. Unless otherwise noted, all information in this manual applies to both devices.
The full delivered energy is different for Intrinsic Model 7288 devices and Intrinsic 30 Model 7287 devices. Intrinsic devices can be programmed to deliver a full energy of up to 35 J. Intrinsic 30 devices can be programmed to deliver up to 30 J. Throughout the manual, the term "full-energy" refers to either 35 J or 30 J, depending on the device model.
Programmer hardware and screen images
11
The screen image examples in this document show the Medtronic CareLink Model 2090 programmer screen. Wherever possible, these screen images show the application for an Intrinsic Model 7288 device.
The information provided in this manual about using the programmer assumes the Medtronic CareLink Model 2090 Programmer is used. For information about using the Model 9790C Programmer, see the
Manual
Manual conventions
Throughout this document, the word “device” refers in general to both Intrinsic and Intrinsic 30 devices.
The nominal value for that parameter.
On-screen buttons are shown with the name of the button surrounded by brackets: [Button Name].
.
symbol in parameter tables indicates the Medtronic
INTRINSIC™/INTRINSIC™30 7288/7287 Reference Manual
9790/9790C Programmer Instruction
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Introduction
Additional literature
Technical support
Before implanting the device, it is strongly recommended that you take the following actions:
Refer to the product literature packaged with the device for
information about prescribing the device.
Thoroughly read the technical manuals for the leads used
with the device.
Discuss the procedure and the device with the patient and
any other interested parties, and provide them with any patient information packaged with the device.
Medtronic employs highly trained representatives and engineers located throughout the world to ser ve you and, upon request, to provide training to qualified hospital personnel in the use of Medtronic products.
In addition, Medtronic maintains a professional staff of consultants to provide technical consultation to product users. For medical consultation, Medtronic can often refer product users to outside medical consultants with appropr iate expertise.
For more information, contact your local Medtronic representative, or call or write Medtronic at the appropriate address or telephone number listed on the back cover.
Customer education
Medtronic invites physicians to attend an educational seminar on the device. The course describes indications for use, system functions, implant procedures, and patient management.
References
The primary reference for background information is Zacouto FI, Guize LJ. Fundamentals of Orthorhythmic Pacing. In: Luderitz B,
Cardiac Pacing Diagnostic and Therapeutic Tools.
ed. Springer-Verlag; 1976: 212-218.
INTRINSIC™/INTRINSIC™30 7288/7287 Reference Manual
New York:
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Notice
Introduction
See these additional references for more background information:
Estes M, Manolis AS, Wang P, Eds.
Cardioverter-Defibrillators
Inc. 1994.
Kroll MW, Lehmann MH, Eds.
Cardioverter-Defibrillator Therapy: The Engineering-Clinical Interface
Singer I, Ed.
NY: Futura Publishing Co. 1994.
Singer I, Barold SS, Camm AJ, Eds.
Therapy of Arrhythmias for the 21st Century: The State of the Art
This software is provided as an informational tool for the end user. The user is responsible for accurate input of patient information into the software. Medtronic makes no representation as to the accuracy or completeness of the data input into the software. Medtronic SHALL NOT BE LIABLE FOR ANY DIRECT, INDIRECT, INCIDENTAL OR CONSEQUENTIAL DAMAGES TO ANY THIRD PARTY WHICH RESULTS FROM THE USE OF THE INFORMATION PROVIDED IN THE SOFTWARE.
. Norwell, MA: Kluwer Academic Publishers 1996.
Implantable Cardioverter-Defibrillator
. Armonk, NY: Futura Publishing Co. 1998.
. New York, NY: Marcel Dekker,
Implantable
Implantable
. Armonk,
Nonpharmacological
13
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Quick overview
Part I
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1Quick reference
1.1 New to Intrinsic 18
1.2 Physical characteristics 18
1.3 Magnet application 20
1.4 Longevity projections 21
1.5 Replacement indicators 23
1.6 Typical charge times 23
1.7 High voltage therapy energy 24
1.8 Stored data and diagnostics 26
1
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Chapter 1
New to Intrinsic
1.1 New to Intrinsic
MVP (Managed Ventricular Pacing) – The MVP modes promote
intrinsic conduction by reducing unnecessary right ventricular pacing. The MVP modes are indicated by AAIR<=>DDDR and AAI<=>DDD on the mode selection screen. These modes provide atrial-based pacing with ventricular backup. For loss of AV conduction, the device switches to DDDR or DDD mode. Periodic checks are performed, and if AV conduction resumes, the device switches back to AAIR or AAI mode.
1.2 Physical characteristics
Table 1-1. Device physical characteristics
Volume
3
Intrinsic
Intrinsic 30
Mass
Intrinsic
Intrinsic 30
H x W x D
Surface area of device can
Radiopaque ID
Materials in contact with human tissue
b
Intrinsic
Intrinsic 30
Intrinsic
Intrinsic 30
c
Intrinsic PUB
Intrinsic 30 PUA
d
38 cm
3
36 cm
76 g
75 g
68 mm x 51 mm x 15 mm
68 mm x 51 mm x 14 mm
2
67 cm
2
66 cm
Titanium/polyurethane/silicone rubber
a
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1Quick reference
A
V
1
2
3
4
5
Physical characteristics
Table 1-1. Device physical characteristicsa(continued)
Battery Lithium silver vanadium oxide
Connectors Two IS-1 connectors for pacing and
a
Measurements are nominal values based on CAD (computer aided design) model measurements and are rounded to the nearest unit.
b
Grommets may protrude slightly beyond the can surface.
c
Engineering series number follows the radiopaque code.
d
These materials have been successfully tested for the ability to avoid biological incompatibility. The device does not produce an injurious temperature in the surrounding tissue.
Table 1-2. Lead connections
Device port Connector type Software name
SVC DF-1 HVX
RV DF-1 HVB
Can n/a HVA; Can
V IS-1 bipolar
A IS-1 bipolar
sensing, Two DF-1 connectors for high voltage therapy, Active Can electrode (programmable)
19
Figure 1-1. Lead connections
1 DF-1 connector port, SVC (HVX) 2 DF-1 connector port, RV (HVB) 3 Device Active Can electrode, Can (HVA) 4 IS-1 connector port, V 5 IS-1 connector port, A
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Chapter 1
Magnet application
Figure 1-2. Suture holes
1.3 Magnet application
Bringing a magnet close to the device triggers changes in device operation as shown in Table 1-3. When the magnet is removed, the device returns to its programmed operations.
Table 1-3. Effects of magnet application on the device
Pacing mode as programmed
Pacing rate and interval as programmed
VF, VT, and FVT detection suspended
Patient Alert audible tones (20 s or less)
a
b
c
a
b
with programmable alerts enabled:
continuous tone (Test)
on/off intermittent tone (seek
follow-up) high/low dual tone (urgent
follow-up)
with programmable alerts disabled:
no tone
high/low dual tone (urgent
follow-up)
Rate response adjustments are suspended while a Patient Alert tone sounds.
Detection resumes if telemetry is established and the application software is running, or it resumes after the application software has started.
The Test tone does not sound if “VF Detection/Therapy Off” is the only alert enabled.
c
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1Quick reference
Longevity projections
1.4 Longevity projections
1.4.1 Intrinsic Model 7288 longevity projections
Longevity estimates are based on accelerated battery discharge data and device modeling with EGM pre–storage off and a 60 ppm pacing rate. The estimates provided in Table 1-4 apply to a delivered therapy energy of 35 J and pacing pulses having a
0.4 ms pulse width and either a 2.5 V or 3 V amplitude.
This model assumes default automatic capacitor formation setting. As a guideline, each full-energy charge decreases device longevity by approximately 31 days.
Table 1-4. Intrinsic Model 7288: Projected longevity in years with 0.4 ms pulse width and 60 ppm pacing rate
Maximum
Pacing
DDD, 0%
energy charging frequency
a
Semi-annual Off
Pre-arrhythmia EGM storage
On
Quarterly Off
On
DDD, 50%
Semi-annual Off
On
Quarterly Off
On
AAI<=>DDD (MVP mode), 50% atrial, 5% ventricular
Semi-annual Off
On
Quarterly Off
On
DDD, 100%
Semi-annual Off
On
Quarterly Off
On
a
Maximum energy charging frequency may include full-energy therapy shocks or capacitor formations.
b
The data provided for programming Pre-arrhythmia EGM on is based on a 6 month period (two 3 month
follow-up intervals) over the life of the device. Additional use of Pre-arrhythmia EGM reduces longevity by approximately 27% or 3 months per year.
500pacing impedance
b
2.5 V 3.0 V 2.5 V 3.0 V
8.5 8.5 8.5 8.5
8.3 8.3 8.3 8.3
7.1 7.1 7.1 7.1
7.0 7.0 7.0 7.0
7.4 7.1 7.9 7.6
7.2 6.9
6.4 6.1 6.7 6.5
6.2 6.0 6.5 6.4
7.6 7.4 7.9 7.8
7.4 7.2
6.5 6.4 6.7 6.6
6.4 6.2 6.6 6.5
6.6 6.1 7.3 6.9
6.4 5.9 7.2 6.8
5.7
5.4 6.3 6.0
5.6 5.2 6.2 5.9
900pacing impedance
7.7
7.7
7.4
7.6
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Chapter 1
Longevity projections
1.4.2 Intrinsic 30 Model 7287 longevity projections
Longevity estimates are based on accelerated battery discharge data and device modeling with EGM pre–storage off and a 60 ppm pacing rate. The estimates provided in Table 1-5 apply to a delivered therapy energy of 30 J and pacing pulses having a
0.4 ms pulse width and either a 2.5 V or 3 V amplitude.
This model assumes default automatic capacitor formation setting. As a guideline, each full-energy charge decreases device longevity by approximately 24 days.
Table 1-5. Intrinsic 30 Model 7287: Projected longevity in years with 0.4 ms pulse width and 60 ppm pacing rate
Maximum
Pacing
DDD, 0%
energy charging frequency
a
Semi-annual Off
Pre-arrhythmia EGM storage
On
Quarterly Off
On
DDD, 50%
Semi-annual Off
On
Quarterly Off
On
AAI<=>DDD (MVP mode), 50% atrial, 5% ventricular
Semi-annual Off
On
Quarterly Off
On
DDD, 100%
Semi-annual Off
On
Quarterly Off
On
a
Maximum energy charging frequency may include full-energy therapy shocks or capacitor formations.
b
The data provided for programming Pre-arrhythmia EGM on is based on a 6 month period (two 3 month
follow-up intervals) over the life of the device. Additional use of Pre-arrhythmia EGM reduces longevity by approximately 25% or 3 months per year.
500pacing impedance
b
2.5 V 3.0 V 2.5 V 3.0 V
8.6 8.6 8.6 8.6
8.5 8.5 8.5 8.5
7.5 7.5 7.5 7.5
7.3 7.3 7.3 7.3
7.5
7.2 8.0 7.8
7.4 7.0 7.9 7.6
6.6 6.4 7.0 6.8
6.5 6.2 6.8 6.7
7.8 7.6 8.1 7.9
7.6 7.4 7.9 7.8
6.8 6.7 7.0 6.9
6.7 6.5 6.9 6.8
6.7 6.2
6.5 6.0 7.3 7.0
6.0
5.5
5.8 5.4 6.4 6.1
900pacing impedance
7.5
7.1
6.6 6.3
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1.5 Replacement indicators
Battery voltage and messages about replacement status appear on the programmer display and on printed reports. Table 1-6 lists the Elective Replacement Indicator (ERI) and the End of Life (EOL) conditions.
Table 1-6. Replacement indicators
Elective Replacement (ERI) 2.62 V
End of Life (EOL) 3 months after ERI
ERI date – The programmer displays the date when the battery reached ERI on the Quick Look and Battery and Lead Measurements screens.
Temporary voltage decrease – The battery voltage temporarily decreases following a high voltage charge. If a battery measurement is taken immediately after a high voltage charge, ERI or EOL indicator may be displayed. However, this is a temporary status which will return to normal when the battery has recovered from the charge.
EOL indication – If the programmer indicates that the device is at EOL, replace the device immediately.
1Quick reference
Replacement indicators
23
Post-ERI conditions – EOL device status is defined as three months following an ERI indication assuming the following post-ERI conditions: 100% DDD pacing at 60 ppm, 3 V, 0.4 ms;
pacing load; and six full-energy charges. EOL may be
500 indicated before the end of three months if the device exceeds these conditions.
1.6 Typical charge times
The most recent capacitor charge time appears on the programmer display and on printed reports and can be evaluated using the Charge/Dump test (see Table 1-7 and Table 1-8).
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Chapter 1
High voltage therapy energy
Table 1-7. Intrinsic Model 7288: typicalafull energy charge times
At Beginning of Life (BOL)
At Elective Replacement (ERI)
a
These charge times are typical when the capacitors are fully formed.
Table 1-8. Intrinsic 30 Model 7287: typicalafull energy charge times
At Beginning of Life (BOL)
At Elective Replacement (ERI)
a
These charge times are typical when the capacitors are fully formed.
1.7 High voltage therapy energy
The stored energy of the device is derived from the peak capacitor voltage and is always greater than the energy delivered by the device. Table 1-9 compares the programmed energy levels delivered by the Intrinsic to the energy levels stored in the capacitors before delivery. Table 1-10 makes the same comparison for the Intrinsic 30 device.
7.0 s
8.9 s
5.9 s
7.5 s
Table 1-9. Intrinsic Model 7288: delivered (programmed) and stored energy levels
Energy ( J)
Delivereda/ Programmed Stored
35 39 7.0
32 37 6.4
30 34 6.0
28 32 5.6
26 30 5.2
25 29 5.0
24 27 4.8
22 25 4.4
20 23 4.0
18 21 3.6
16 19 3.2
15 17 3.0
14 16 2.8
13 15 2.6
INTRINSIC™/INTRINSIC™30 7288/7287 Reference Manual
b
Charge Timec( s)
Delivereda/ Programmed Stored
Energy ( J)
b
10 12 2.0
9 10.5 1.8
8 9.3 1.6
7
6 7.1 1.2
5
4 4.8 0.8
3 3.6 0.6
2 2.4 0.4
1.8 2.2 0.4
1.6 2.0 0.3
1.4 1.7 0.3
1.2 1.5 0.2
1.0 1.2 0.2
8.2 1.4
5.9 1.0
Charge Timec( s)
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1Quick reference
High voltage therapy energy
Table 1-9. Intrinsic Model 7288: delivered (programmed) and stored energy levels (continued)
25
Energy ( J)
Delivereda/ Programmed Stored
12 14 2.4
11 13 2.2
b
Charge Timec( s)
Delivereda/ Programmed Stored
Energy ( J)
Charge
b
Timec( s)
0.8 1.0 0.2
0.6 0.8 0.1
0.4 0.5 0.1
a
Energy delivered at connector block into a 75
b
Energy stored at end of charge on capacitor.
c
Typical charge time at Beginning of Life (BOL) with fully formed capacitors, rounded to the nearest tenth
of a second.
load.
Table 1-10. Intrinsic 30 Model 7287: delivered (programmed) and stored energy levels
Energy ( J)
Delivereda/ Programmed Stored
b
Charge Timec( s)
Delivereda/ Programmed Stored
30 35 5.9
28 33 5.6
26 31 5.2
24 28 4.7
22 26 4.4
20 24 4.0
18 21 3.5
16 19 3.2
15 18 3.0
14 16 2.7
13 15 2.5
12 14 2.4
11 13 2.2
10 12 2.0
9 11 1.9
a
Energy delivered at connector block into a 75
b
Energy stored at end of charge on capacitor.
c
Typical charge time at Beginning of Life (BOL) with fully formed capacitors, rounded to the nearest tenth of a second.
load.
Energy ( J)
Charge
b
Timec( s)
8 9.4 1.6
7
8.3 1.4
6 7.1 1.2
5
5.9 1.0
4 4.7 0.8
3 3.6 0.6
2 2.4 0.4
1.8 2.2 0.4
1.6 2.0 0.3
1.4 1.7 0.3
1.2 1.5 0.3
1.0 1.2 0.2
0.8 1.0 0.2
0.6 0.8 0.1
0.4 0.5 0.1
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Chapter 1
Stored data and diagnostics
1.8 Stored data and diagnostics
Table 1-11. Stored data and diagnostics
Episode data
Tachy episodes 150 VF/VT/FVT episodes: intervals, text, EGM
EGM capacity for tachy episodes 14 minutes of dual-channel EGM, or 23.5 minutes of
SVT/NST episodes 50 SVT/NST episodes: intervals, text, EGM (the device
EGM capacity for SVT/NST episodes
Brady episodes 53 mode switch episodes
EGM sources 9 options: atrial/ventricular/far-field
EGM options Store before onset; Store during charging
Flashback memory 2000 intervals (containing both A-A and V-V): before latest
Counter data
Detection counters Lifetime total, since cleared, and since last session
Episode counters Episodes:
Therapy efficacy counters Counts for each VF, FVT, VT Therapy:
Other stored data
Patient Alert events Up to 10 log entries: text and date for the first time an alert
single-channel EGM
does not usually store detailed episode records for NST episodes)
2 minutes of dual-channel EGM, or 3.6 minutes of single-channel EGM
VF, before latest VT, and before interrogation
Percentage pacing:
Additional counters:
Total number of aborted shocks
is triggered between interrogations
VF, FVT, and VT Atrial Fibrillation/Atrial Flutter episodes Sinus Tach episodes Other 1:1 SVT episodes NST episodes Mode switch episodes
AS-VS, AS-VP, AP-VS, AP-VP percentages
Single PVCs and PVC runs Rate stabilization pulses and runs
Delivered Successful Unsuccessful Intervention (manually aborted)
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Table 1-11. Stored data and diagnostics (continued)
1Quick reference
Stored data and diagnostics
27
Battery and lead measurements Battery voltage, last capacitor formation, last charge, lead
Lead performance trends 14 days of daily measurements plus 80 weeks of weekly
Cardiac Compass trends 14 months of measurement trends:
impedance, EGM amplitude measurements, last high voltage therapy, and sensing integrity counter
minimum and maximum measurements:
Lead impedance: atrial pacing, ventricular pacing,
defibrillation pathway, and SVC lead (if used) EGM amplitude: atrial (P-waves), ventricular
(R-waves)
VT and VF episodes per day
High voltage therapies delivered per day
Ventricular rate during VT or VF
Episodes of non-sustained tachycardia per day
Heart rate variability
Total daily time in AF or AT
Ventricular rate during AF or AT
Percent pacing per day
Patient activity
Average day and night ventricular heart rate
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2The Intrinsic system
2.1 System overview 30
2.2 Indications and usage 33
2.3 Contraindications 33
2.4 Patient screening 33
2
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Chapter 2
System overview
2.1 System overview
The Intrinsic and Intrinsic 30 Dual Chamber Implantable Cardioverter Defibrillator (ICD) systems are implantable medical device systems that automatically detect and treat episodes of ventricular fibrillation, ventricular tachycardia, fast ventricular tachycardia, and bradyarrhythmia. The device system includes three major components:
ICD
The ICD senses the electrical activity of the patient’s heart via the sensing electrodes of the implanted atrial and ventricular leads. It then analyzes the heart rhythm based on selectable sensing and detection parameters. If the device detects a tachyarrhythmia, it delivers defibrillation, cardioversion, or antitachycardia pacing therapy to the patient’s heart. If the device identifies a bradyarrhythmia, it delivers bradycardia pacing therapy to the patient’s heart.
Leads
The ICD can be used with transvenous or epicardial defibrillation leads. The lead system should consist of bipolar or paired unipolar1pacing/sensing leads in each chamber of the hear t and one or two high voltage cardioversion/defibrillation electrodes. You can program the Active Can device case as a high voltage electrode. The pacing and sensing electrodes in each chamber sense cardiac activity and deliver pacing stimuli.
Programmer and software
The Medtronic programmer and application software (Model 9997 for Intrinsic and Model 9996 for Intrinsic 30) allow you to perform the following tasks:
– configure the detection, therapy, and bradycardia features
for your patient
– perform electrophysiological studies and system tests
– monitor, display, or print patient cardiac activity
information
– view patient and device diagnostic data
1
With an appropriate unipolar to bipolar adapter kit.
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2The Intrinsic system
System overview
The Intrinsic devices and 9997/9996 application software are compatible with the following programmer systems:
Medtronic CareLink Model 2090 programmer with a Model
2067 or 2067L programming head
Medtronic Model 9790C programmer with a Model 9767
or 9767L programming head
For information about:
indications, contraindications, lead compatibility, warnings
and precautions, and patient selection, see the implant manual accompanying the device.
basic programmer and software desktop functions
that are not included in Chapter 10, “Using the programmer”, page 211, see the manual accompanying the programmer.
installing the programming head, see the manual
accompanying the programming head.
implanting leads, refer to the manuals accompanying
the leads.
31
2.1.1 Detecting and treating tachyarrhythmias
The device monitors the cardiac rhythm for short ventricular intervals that may indicate the presence of VF, VT, or FVT.
Upon detection of VF, the device delivers a biphasic
defibrillation shock of up to full energy. If the VF episode persists, up to five more individually programmed defibrillation shocks can be delivered.
Upon detection of VT, the device delivers either a Ramp,
Ramp+, or Burst antitachycardia pacing therapy or a biphasic cardioversion shock of up to full energy synchronized to a ventricular depolarization. If the VT episode persists, up to five more individually programmed VT therapies can be delivered. You can also program the ICD to monitor the VT episode without delivering therapy.
Upon detection of FVT, the device delivers either a Ramp,
Ramp+, or Burst antitachycardia pacing therapy or a biphasic cardioversion shock of up to full energy synchronized to a ventricular depolarization. If the FVT episode persists, up to five more individually programmed FVT therapies can be delivered.
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Chapter 2
System overview
2.1.2 Treating bradycardia
You can program the device to distinguish between true ventricular arrhythmias and rapidly conducted supraventricular tachycardia (SVT) and withhold therapy for SVT.
To ensure proper detection and therapy during double tachycardia episodes (VT, FVT, or VF in the presence of SVT), the device provides double tachyarrhythmia detection whenever PR Logic detection criteria are enabled. The device detects double tachycardia episodes using both rate and PR Logic pattern and rate analysis information.
The device provides rate responsive pacing to treat bradycardia. An internal accelerometer senses the patient’s physical activity, allowing the device to increase and decrease the pacing rate in response to changes in the level of activity. The device provides dual chamber pacing, single chamber pacing, and MVP (Managed Ventricular Pacing) modes. The MVP modes switch between single chamber atrial pacing and dual chamber pacing to promote intrinsic conduction by reducing unnecessary right ventricular pacing.
2.1.3 Monitoring for real-time and stored data
The device and programmer provide real-time information on detection and therapy parameters and status during a patient session. The device also provides accumulated data on device operation, including stored electrograms, detected and treated tachyarrhythmia episodes, bradycardia interventions, and the efficacy of therapy. The Cardiac Compass report provides up to 14 months of clinically significant data, including arrhythmia episodes, therapies delivered, physical activity, heart rate, and bradycardia pacing activities.
All of this information can be printed and retained in the patient’s file or saved in electronic format on a floppy diskette.
2.1.4 Conducting electrophysiologic tests
You can use the system to conduct non-invasive electrophysiologic studies including manual delivery of any of the device therapies to manage an induced or spontaneous tachyarrhythmia.
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2.1.5 Alerting the patient to system events
You can use the programmable Patient Alert monitoring feature to notify the patient with audible tones if certain conditions related to the leads, battery, charge time, and therapies occur. The patient can then respond based on your prescribed instructions.
2.2 Indications and usage
The implantable cardioverter defibrillator is intended to provide ventricular antitachycardia pacing and ventricular defibrillation for automated treatment of life threatening ventricular arrhythmias.
2.3 Contraindications
The Intrinsic Model 7288 and Intrinsic 30 Model 7287 ICD systems are contraindicated for:
patients whose tachyarrhythmias may have transient or
reversible causes, such as acute myocardial infarction, digitalis intoxication, drowning, electric shock, electrolyte imbalance, hypoxia, or sepsis
patients with incessant VT or VF
patients who have a unipolar pacemaker
patients whose primary disorder is bradyarrhythmias or atrial
arrhythmias
2The Intrinsic system
Indications and usage
33
2.4 Patient screening
Prior to implant, patients should undergo a complete cardiac evaluation, including electrophysiologic testing. Also, electrophysiologic evaluation and testing of the safety and efficacy of the proposed tachyarrhythmia therapies are recommended during and after the implantation of the device.
Other optional screening procedures could include exercise stress testing to determine the patient’s maximum sinus rate, and cardiac catheterization to determine if there is a need for concomitant surgery and/or medical therapy.
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3Emergency therapy
3.1 Delivering emergency therapies 36
3.2 Delivering an emergency defibrillation therapy 37
3.3 Delivering an emergency cardioversion therapy 38
3.4 Delivering emergency fixed burst pacing 39
3.5 Enabling emergency VVI pacing 40
3
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Chapter 3
Delivering emergency therapies
3.1 Delivering emergency therapies
The device provides the following emergency therapies:
defibrillation
cardioversion
fixed burst pacing
emergency VVI pacing
The default emergency therapy is full-energy defibrillation. When you select [Emergency] and [DELIVER], the device charges and delivers a biphasic full-energy shock along the AX>B pathway.
The programmer sets the emergency defibrillation energy to full energy each time you select [Emergency]. Emergency cardioversion and fixed burst values remain as selected for the duration of the session.
To return to other programming functions from an Emergency screen, select [Exit Emergency].
1
3.1.1 Effect on system operation
The device suspends the automatic detection features when emergency defibrillation, cardioversion, or fixed burst pacing therapies are delivered. Detection is not suspended during emergency VVI pacing. Removing the programming head or pressing [Resume] turns detection on again.
3.1.2 Aborting an emergency therapy
As a safety precaution, the programmer also displays an [ABORT] button which immediately terminates any emergency therapy in progress.
1
If Active Can is turned off, the defibrillation is delivered between the HVX and HVB electrodes.
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3Emergency therapy
Delivering an emergency defibrillation therapy
3.1.3 Mechanical Emergency buttons on the Model 9790C programmer
If you press the red mechanical Emergency button on the programmer display panel, the programmer displays the Emergency screen. The mechanical yellow-on-blue deliver button activates the emergency therapy displayed on the programmer screen. This button functions only when the Emergency screen is displayed.
3.1.4 Mechanical Emergency VVI button on the Medtronic CareLink Model 2090 programmer
If you press the red Emergency VVI button on the programmer display panel, the device initiates Emergency VVI pacing and the programmer displays the Emergency screen.
3.1.5 Temporary parameter values
37
Emergency tachyarrhythmia therapies use temporary values that do not change the programmed parameters of the device. These values are not in effect until you select [DELIVER]. After the tachyarrhythmia therapy is complete, the device reverts to its programmed values.
3.2 Delivering an emergency defibrillation therapy
The default emergency therapy is a full-energy defibrillation. When you select [Emergency] and [DELIVER], the device charges and delivers a biphasic full-energy shock. The programmer sets the emergency defibrillation energy to its maximum value each time you select [Emergency] or select the [Defibrillation] option from an Emergency screen.
3.2.1 Parameters
Energy – Amount of energy
delivered to the heart by the therapy.
Intrinsic
10; 11 … 16; 18; 20; 22; 24; 25; 26; 28; 30; 32; 35
2
J
2
Delivery of Emergency VVI Pacing changes the programmed bradycardia pacing values to the emergency values (see Section 3.5.2, page 41).
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38
2
3
4
Chapter 3
Delivering an emergency cardioversion therapy
Intrinsic 30
Pathwaya– Direction the electrical current flows through the heart.
a
If Active Can is Off, the HVA (Can) electrode is not used as part of the high-voltage delivery pathway.
3.2.2 How to deliver emergency defibrillation
10; 11 … 16; 18; 20; 22; 24; 26; 28; 30
AX>B (fixed)
1. Position the programming head over the device.
2. Select [Emergency].
3. Accept the defibrillation energy shown on the screen, or select a new Energy value.
4. Select [DELIVER].
If delivery is not confirmed, verify that the programming head is properly positioned, and select [Retry] or [Cancel].
J
3.3 Delivering an emergency cardioversion therapy
When you initiate an emergency cardioversion therapy, the device charges its capacitors to the selected energy and attempts to deliver therapy synchronized with a sensed tachyarrhythmia event. If the cardioversion therapy cannot be synchronized, it is aborted. See Section 7.3.5.6, “Synchronizing cardioversion after charging”, page 138.
3.3.1 Parameters
Energy – Amount of energy
delivered to the heart by the therapy.
Intrinsic
INTRINSIC™/INTRINSIC™30 7288/7287 Reference Manual
0.4; 0.6 … 1.8; 2; 3 … 16; 18; 20; 22; 24; 25; 26; 28; 30; 32;
J
35
Page 39
3Emergency therapy
3
2
5
4
Delivering emergency fixed burst pacing
39
Intrinsic 30
Pathwaya– Direction the electrical current flows through the heart.
a
If Active Can is Off, the HVA (Can) electrode is not used as part of the high-voltage delivery pathway.
3.3.2 How to deliver emergency cardioversion
0.4; 0.6 … 1.8; 2; 3 … 16; 18; 20; 22; 24; 26; 28; 30
J
AX>B (fixed)
1. Position the programming head over the device.
2. Select [Emergency].
3. Select [Cardioversion].
4. Accept the cardioversion energy shown on the screen, or select a new Energy value.
5. Select [DELIVER].
If delivery is not confirmed, verify that the programming head is properly positioned, and select [Retry] or [Cancel].
3.4 Delivering emergency fixed burst pacing
Emergency fixed burst pacing delivers maximum output pacing pulses to the ventricle at a selectable interval. The therapy continues for as long as you keep the programmer stylus on the [BURST Press and Hold] button.
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40
2
5
3
4
Chapter 3
Enabling emergency VVI pacing
3.4.1 Parameters
Interval – Time interval between
pacing pulses delivered during the fixed burst therapy.
V. Amplitude – Voltage of the ventricular pacing pulses delivered during the fixed burst therapy.
V. Pulse Width – Duration of the ventricular pacing pulses delivered during the fixed burst therapy.
100; 110 … 350 370 … 600 ms
8 V (fixed)
1.6 ms (fixed)
3.4.2 How to deliver emergency fixed burst pacing
1. Position the programming head over the device.
2. Select [Emergency].
3. Select [Fixed Burst].
4. Accept the pacing interval shown on the screen, or select a new interval value.
5. Select [BURST Press and Hold].
If delivery is not confirmed, the programmer displays an error window. Verify that the programming head is properly positioned. Select [OK] from the window and reselect [BURST Press and Hold].
… 360;
3.5 Enabling emergency VVI pacing
Emergency VVI pacing programs the device to deliver high-output ventricular pacing. You can initiate emergency VVI pacing from the Emergency screen or by pressing the red mechanical button on the Medtronic CareLink Model 2090 programmer display panel. To disable emergency VVI pacing, reprogram the bradycardia pacing parameters from the Brady Pacing Parameters screen.
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3.5.1 Parameters
4
2
3
3Emergency therapy
Enabling emergency VVI pacing
41
Pacing Mode – NBG Codeafor the pacing mode provided during emergency VVI pacing.
Lower Rate – Minimum pacing rate to maintain adequate heart rate during periods of inactivity.
V. Amplitude – Voltage of the ventricular pacing pulses delivered during emergency VVI pacing.
V. Pulse Width – Duration of the ventricular pacing pulses delivered during emergency VVI pacing.
V. Pace Blanking – Time interval during which sensing is disabled after a pacing pulse.
Hysteresis – Enables tracking of intrinsic heart rate below programmed Lower Rate to prevent pacing during extended periods of inactivity, such as when a patient is sleeping.
V. Rate Stabilization – Modifies the pacing rate to eliminate the long pause that typically follows a premature ventricular contraction.
a
N–North American Society of Pacing and Electrophysiology (NASPE), B–British Pacing and Electrophysiology Group (BPEG), G–Generic Pacemaker Code
3.5.2 How to deliver emergency VVI pacing
VVI
70 ppm
6 V
1.6 ms
240 ms
Off
Off
1. Position the programming head over the device.
2. Select [Emergency].
3. Select [VVI Pacing].
4. Select [PROGRAM] to change the pacing parameters to the emergency VVI settings.
If programming is not confirmed, verify that the programming head is properly positioned and select [Retry] or [Cancel].
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Part II
Device implant and patient follow-up procedures
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Page 45
4Implanting the device
4.1 Overview 46
4.2 Preparing for an implant 46
4.3 Replacing a device 48
4.4 Positioning the leads 49
4.5 Testing sensing and pacing thresholds 51
4.6 Connecting the leads to the device 52
4.7 Testing defibrillation operation and effectiveness 54
4.8 Positioning and securing the device 58
4.9 Completing the implant procedure 58
4
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46
Chapter 4
Overview
4.1 Overview
The tasks for implanting a device include:
1. Preparing for an implant (see Section 4.2, page 46)
2. Replacing a device (see Section 4.3, page 48)
3. Positioning the leads (see Section 4.4, page 49)
4. Testing sensing and pacing thresholds (see Section 4.5, page 51)
5. Connecting the leads to the device (see Section 4.6, page 52)
6. Testing defibrillation operation and effectiveness (see Section 4.7, page 54)
7. Positioning and securing the device (see Section 4.8, page 58)
8. Completing the implant procedure (see Section 4.9, page 58)
These tasks are described in the sections that follow.
4.2 Preparing for an implant
Warning: Keep a backup external defibrillator available
during the implant for transthoracic rescue when arrhythmias are induced.
4.2.1 Equipment for an implant
Medtronic CareLink Model 2090 programmer with a Model
2067 or 2067L programming head, or a Model 9790C programmer with a Model 9767 or 9767L programming head
Model 9997 and Model 9996 software applications
Model 2290 or 8090 Analyzer lead analysis device or
equivalent pacing system analyzer
external defibrillator
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Preparing for an implant
4.2.2 Sterile supplies for an implant
The sterile supplies that are needed for an implant are as follows:
implantable device and lead system components
programming head sleeve or programming head
analyzer cables
lead introducers appropriate for the lead system
extra stylets of appropriate length and shape
4.2.3 Set up the programmer and start the application
1. Set up the programmer as described in the instructions provided with the programmer.
2. Install the Model 9997 and Model 9996 software applications on the programmer, if they are not already installed.
3. Place the programming head over the device and start the application. Select the device model or select [Auto identify].
Note: The programmer automatically interrogates the device when the application starts.
4Implanting the device
47
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48
Chapter 4
Replacing a device
4.2.4 Preprogram the device
Before opening the sterile package, prepare the device for implant as follows:
1. Check the “use by” date printed on the package. Do not implant the device after the “use by” date because the battery’s longevity could be reduced.
2. Interrogate the device, and print a full summary report.
3. Confirm that the battery voltage is at least 3.0 V at room temperature.
If the device has been exposed to lower temperatures or has delivered a recent high voltage charge, the battery voltage will be temporarily lower.
4. Set up data collection parameters and the device internal clock (see Section 12.2.3, page 265).
5. Perform a manual capacitor formation (see Section 13.6, page 305).
6. Program the therapy and pacing parameters to values appropriate for the patient (see Section 8.1.4, page 151). Ensure that all tachyarrhythmia detection is programmed Off (see Section 6.1, page 70).
1
4.3 Replacing a device
If you are replacing a previously implanted device, turn off device detection and therapies before explanting.
When implanting the device with a chronic lead system, perform the following evaluations to ensure appropriate detection and therapy:
Check the integrity of the chronic high voltage leads with a
test shock, chest x-ray, and inspection.
Perform chronic pacing and sensing measurements.
Measure high voltage lead impedances.
Test defibrillation efficacy.
Confirm adequate sensing during VF.
Ensure proper fit of the lead connectors in the device
connector block.
1
Use the Quick Look screen to verify the voltage, see Section 11.2, page 247.
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Notes:
To meet the implant requirements, it may be necessar y to
reposition or replace the chronic leads or to add a third high voltage electrode.
Any unused leads that remain implanted must be capped.
4.3.1 How to explant and replace a device
1. Program all tachyarrhythmia detection Off.
2. Dissect the leads and the device free from the surrounding tissues in the surgical pocket. Be careful not to nick or breach the lead insulation during the process of exposing the system.
3. Loosen each setscrew, and gently retract the lead from the connector block.
4. Remove the device from the surgical pocket.
5. If the connector pin of any implanted lead shows signs of pitting or corrosion, replace the implanted lead with a new lead. The damaged lead should be discarded and replaced to assure the integrity of the device system.
6. Measure sensing, pacing, and defibrillation efficacy using the replacement device.
7. Evaluate the defibrillation efficacy of the replacement system.
4Implanting the device
Positioning the leads
49
4.4 Positioning the leads
Implant endocardial leads according to the supplied instructions, unless suitable chronic leads are already in place. Do not use any lead with this device without first verifying connector compatibility (refer to the implant manual accompanying the device). Transvenous or epicardial leads may be used. A bipolar atrial lead with closely spaced pacing and sensing electrodes is recommended.
4.4.1 Using transvenous leads
Use standard transvenous implant techniques to position the ventricular lead tip in the right ventricular apex and the atrial pacing lead tip high on the right atrial appendage.
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Chapter 4
Positioning the leads
4.4.2 Using epicardial leads
Follow the general guidelines below for initial positioning of other transvenous leads (the final positions are determined by defibrillation efficacy tests):
SVC (HVX) lead: Place the lead tip high in the innominate
vein, approximately 5 cm (2 in) proximal to the right atrium (RA) and SVC junction.
SQ patch: Place the patch along the left mid-axillary,
centered over the fourth-to-fifth intercostal space.
CS lead: Advance the lead tip to just under the left atrial
appendage, if possible.
If using a subclavian approach, position the lead laterally to avoid pinching the lead body between the clavicle and the first rib.
Warning: Pinching the lead can damage the lead conductor or insulation, which may cause unwanted high-voltage therapies or result in the loss of sensing or pacing therapy.
A variety of surgical approaches can be used to implant epicardial leads, including a limited left thoracotomy or median sternotomy. A typical placement may use an anterior right ventricular patch as the RV (HVB) and a posterolateral left ventricular patch as SVC (HVX).
Follow the general guidelines below for positioning epicardial leads:
If unipolar epicardial pacing leads are used, position the
electrodes about 1 cm to 2 cm (0.4 in to 0.8 in)apart to reduce electromagnetic interference, and route the leads together with several loose twists.
Suture the smooth face of each patch lead against the
epicardium or pericardium in locations that produce optimal defibrillation.
Place the patches so that they encompass the maximum
amount of cardiac mass and they have approximately equal amounts of mass between them.
Ensure that the patches do not overlap and the electrode
portions do not touch.
Avoid placing extra-pericardial patches over the phrenic
nerve.
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4Implanting the device
Testing sensing and pacing thresholds
4.4.3 Surgical incisions
A single-incision submuscular or subcutaneous approach is recommended when the device is implanted in the pectoral region. Make the implant pocket about 1.5 times the size of the device.
Submuscular implant – An incision extending over the deltoid-pectoral groove typically provides access to the cephalic and subclavian veins as well as the implant pocket. Place the device sufficiently medial to the humeral head to avoid interference with shoulder motion.
Subcutaneous implant – A transverse incision typically permits isolation of the cephalic vein. Place the device far medially to keep the leads away from the axilla. Make sure that the upper edge of the device remains inferior to the incision.
4.5 Testing sensing and pacing thresholds
Sensing and pacing tests include the following measurements:
EGM amplitude
slew rate
pacing threshold
pacing lead impedance
51
4.5.1 Parameters
Medtronic recommends that you use a Model 2290 or 8090 Analyzer lead analysis device to perform sensing and pacing measurements. If you use a Pacing System Analyzer (PSA), perform both atrial and ventricular measurements via the ventricular channel of the PSA.
Refer to the technical manual for the Analyzer you use to find details on performing sensing and pacing measurements.
Measured sensing and pacing values must meet the following specific requirements at implant.
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Chapter 4
Connecting the leads to the device
4.5.2 Considerations
Table 4-1. Sensing and pacing values at implant
Measurement Acute transvenous leads
R-wave amplitude 5 mV 3 mV
P-wave amplitude 2 mV 1 mV
Slew rate:
atrial 0.5 V/s 0.3 V/s
ventricular 0.75 V/s 0.5 V/s
Capture thresholda:
atrial 1.5 V 3.0 V
ventricular 1.0 V 3.0 V
a
At 0.5 ms pulse width
Chronic leads
When measuring sensing and pacing values, measure between the tip (cathode) and ring or coil (anode) of each bipolar pacing/sensing lead.
For unipolar epicardial pacing leads, either electrode can be the cathode; use the configuration that yields the lower pacing threshold.
Note: Do not measure the intracardiac EGM telemetered from the device to assess sensing.
4.6 Connecting the leads to the device
For more detailed information about lead/connector compatibility, see the implant manual accompanying the device, or contact your Medtronic representative.
Table 4-2. Lead connections
Device port Connector type Software name
SVC DF-1 HVX
RV DF-1 HVB
Can n/a HVA, Can
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4Implanting the device
A
V
1
2
3
4
5
Connecting the leads to the device
Table 4-2. Lead connections (continued)
Device port Connector type Software name
V IS-1 bipolar
A IS-1 bipolar
Figure 4-1. Lead connections
1 DF-1 connector port, SVC (HVX) 2 DF-1 connector port, RV (HVB) 3 Device Active Can electrode, Can (HVA) 4 IS-1 connector port, V 5 IS-1 connector port, A
Warning: Loose lead connections may result in inappropriate sensing and failure to deliver necessary arrhythmia therapy.
53
Caution: Use only the torque wrench supplied with the device. It is designed to prevent damage to the device from overtightening a setscrew.
For easier lead insertion, insert the ventricular IS-1 leg before the other legs.
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Chapter 4
Testing defibrillation operation and effectiveness
4.6.1 How to connect the lead to the device
1
b
a
2
1. Insert the torque wrench into the appropriate setscrew.
a. If the port is obstructed,
retract the setscrew to clear it. Take care not to disengage the setscrew from the connector block.
b. Leave the torque wrench in
the setscrew until the lead is secure. This allows a pathway for venting trapped air when the lead is inserted.
2. Push the lead or plug into the connector port until the lead pin is clearly visible in the pin viewing area. No sealant is required, but sterile water may be used as a lubricant.
3. Tighten the setscrew by turning clockwise until the torque wrench clicks.
4. Tug gently on the lead to confirm a secure fit. Do not pull on the lead until all setscrews have been tightened.
5. Repeat these steps for each lead.
4.7 Testing defibrillation operation and effectiveness
Demonstrate reliable defibrillation effectiveness with the implanted lead system by using your preferred method to establish that a 10 J (minimum) safety margin exists.
Note: If the 10 J (minimum) safety margin cannot be ensured, see Section 15.4, “Solving tachyarrhythmia therapy problems”, page 329.
4.7.1 High-voltage implant values
Measured values must meet the following requirements at implant.
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4Implanting the device
Testing defibrillation operation and effectiveness
Table 4-3. High-voltage therapy values at implant
Measurement Acute or chronic leads
V. Defib impedance
SVC (HVX) impedance (if applicable)
20 – 200
20 – 200
Defibrillation threshold
Intrinsic 25 J
Intrinsic 30 20 J
Warning: Ensure that an external defibrillator is charged for a rescue shock.
4.7.2 How to prepare for defibrillation threshold testing
1. Place the programming head over the device, start a patient session, and interrogate the device, if you have not already done so.
2. Observe the Marker Channel telemetry annotations and the programmer ECG display to verify that the device is sensing properly.
2
3. Conduct a manual Lead Impedance Test lead connections. Perform this test with the device in the surgical pocket and keep the pocket very moist. If the impedance is out of range, perform one or more of the following tasks:
Recheck lead connections and electrode placement.
Repeat the measurement.
Inspect the bipolar EGM for abnormalities.
Measure the defibrillation impedance with a manual test shock.
4. Program the device or support instrument to properly detect VF with an adequate safety margin (1.2 mV sensitivity).
to verify the defibrillation
55
2
See Section 13.4, “Measuring lead impedance”, page 302.
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1
2
3
4
12
14
8
9
13
5
6
7
11
10
Chapter 4
Testing defibrillation operation and effectiveness
4.7.3 How to perform defibrillation threshold testing using T-Shock
1. Select Tests > EP Study.
2. Select T-Shock from the Inductions/Therapies box.
3. Select [Resume at DELIVER] to resume arrhythmia detection after induction delivery.
4. Select [Adjust Permanent …].
5. Set the VF detection, Ventricular Sensitivity, and VF therapy parameters. VF Enable should be On, and the Energy parameter for VF Therapies 2–6 should be set to the maximum value.
6. Select [Program].
7. Select [Close].
8. Select Enable.
9. Select [DELIVER T-Shock]. If necessary, you can abort an induction or therapy in progress by selecting [ABORT].
10. Observe the live rhythm monitor for proper post-shock sensing.
11. Use the [Adjust Permanent …] button to program a new energy level, if desired.
12. Wait until the on-screen timer reaches 5 minutes, then repeat Step 8 through Step 12 as needed.
13. Select Params > Detection, and disable VF, FVT, and VT detection before closing the pocket.
14. Interrogate the device, and print an episode summary report.
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4Implanting the device
1
2
4
12
13
5
7
6
8
11
10
3
9
Testing defibrillation operation and effectiveness
4.7.4 How to perform defibrillation threshold testing using 50 Hz Burst
1. Select Tests > EP Study.
2. Select 50 Hz Burst from the Inductions/Therapies box.
3. Select [Resume at BURST] to resume arrhythmia detection after induction delivery.
4. Select [Adjust Permanent …].
5. Set the VF detection, Ventricular Sensitivity, and VF therapy parameters. VF Enable should be On, and the Energy parameter for VF Therapies 2–6 should be set to the maximum value.
6. Select [Program].
7. Select [Close].
8. Press and hold [50 Hz BURST Press and Hold]. If necessary, you can abort an induction or therapy in progress by selecting [ABORT].
9. Observe the live rhythm monitor for proper post-shock sensing.
10. Use the [Adjust Permanent …] button to program a new energy level, if desired.
11. Wait until the on-screen timer reaches 5 minutes, then repeat Step 8 through Step 11 as needed.
12. Select the Params > Detection and disable VF, FVT, and VT detection before closing the pocket.
13. Interrogate the device, and print an episode summary report.
57
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Chapter 4
Positioning and securing the device
4.8 Positioning and securing the device
Cautions:
If no SVC electrode is implanted, the pin plug provided
with the device must be secured in the SVC port.
Program tachyarrhythmia detection Off before closing.
4.8.1 How to position and secure the device
1. Ensure that each lead pin or plug is fully inserted into the connector block and that all setscrews are tight.
2. Coil any excess lead length beneath the device. Avoid kinks in the lead conductors.
3. Implant the device within 5 cm of the skin. This position optimizes the ambulatory monitoring operations.
4. Suture the device securely within the pocket to minimize post-implant rotation and migration of the device. Use a surgical needle to penetrate the suture holes (indicated by arrows in the drawing).
4.9 Completing the implant procedure
After implanting the device, x-ray the patient to verify device and lead placement. To complete programming the device, select parameters that are appropriate for the patient.
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Completing the implant procedure
4.9.1 How to complete programming the device
1. After closing the pocket, program detection On. Program ventricular tachyarrhythmia therapies On as desired.
2. Do not enable the Other 1:1 SVTs PR Logic detection criterion until the atrial lead has matured (approximately one month post implant).
3. Monitor the patient after the implant, and take x-rays as soon as possible to document and assess the location of the leads.
4. Program patient information. See Section 12.10.1, “How to view and enter new patient information”, page 294.
5. Configure the Patient Alert feature. See Section 11.3, “Using the Patient Alert feature”, page 249.
6. Set up data collection parameters. See Section 12.2, “Setting up data collection”, page 263.
7. Interrogate the device after any spontaneous episodes to evaluate the detection and therapy parameter settings.
8. If the patient has not experienced spontaneous episodes, you may induce the clinical tachyarrhythmias using the non-invasive EP Study features to further assess the performance of the system. See Chapter 14, “Conducting Electrophysiologic Studies”, page 307.
9. Recheck pacing and sensing values, and adjust if necessary.
4Implanting the device
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5Conducting a patient follow-up session
5.1 Patient follow-up guidelines 62
5.2 Verifying the status of the implanted system 62
5.3 Verifying accurate detection and appropriate therapy 63
5.4 Verifying effective bradycardia pacing 64
5
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Chapter 5
Patient follow-up guidelines
5.1 Patient follow-up guidelines
Schedule regular patient follow-up sessions to monitor the condition of the device and leads and to verify that the device is configured appropriately for your patient.
During the first few months after receiving a new device, the patient may require close monitoring. Schedule an office visit at least every three months.
The Quick Look screen, which is displayed after you interrogate the device, provides a good beginning for the follow-up review. Using this screen you can:
verify that the device is functioning correctly.
review the clinical performance and long term trends.
print appropriate reports1to compare the results to the
patient’s history and to retain for future reference.
Note: The Checklist feature provides a standard list of tasks to perform at a complete follow-up visit. You can also customize your own checklists if you wish. See Section 11.4, “Streamlining follow-ups with Checklist”, page 256 for more information.
5.2 Verifying the status of the implanted system
To verify that the device and leads are functioning correctly, review the following information from the Quick Look screen and perform follow-up tests as indicated:
Review the displayed battery voltage for comparison to the
Elective Replacement Indicator value (see Section 1.5, page 23). Remember that battery voltage may be low if high voltage charging has occurred within 24 hours.
Review the last full energy charge.
– For information about adjusting the capacitor formation
interval, see Section 4.2, “Preparing for an implant”, page 46.
– If the programmer displays an Excessive Charge Time
ERI, the device should be replaced immediately.
1
See Section 12.9, “Using Cardiac Compass to view long term clinical trends”, page 285 for information on this new report.
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5Conducting a patient follow-up session
Verifying accurate detection and appropriate therapy
Review the defibrillation and pacing lead impedance values
for inappropriate values or large changes since the last follow-up. See Section 13.4, “Measuring lead impedance”, page 302.
Perform an EGM Amplitude test in each chamber for
comparison to previous EGM Amplitude measurements. See Section 13.5.4, “How to perform an EGM Amplitude test”, page 305.
To review longer term trends in sensing and impedance
measurements, select the [>>] button from the lead impedance area of the Quick Look screen. The programmer displays a detailed history of automatic sensing and impedance measurements. See Section 11.2, “Taking a quick look at device activity”, page 247.
5.3 Verifying accurate detection and appropriate therapy
To verify that the device is providing effective tachyarrhythmia detection and therapy, review the following information from the Quick Look screen and investigate as indicated:
63
5.3.1 Considerations
Review the following information before verifying detection and therapy.
Flashback memory – In addition to the episode text and stored electrograms, use Flashback memory and interval plots to help investigate the accuracy and specificity of ventricular detection.
Review Quick Look Observations that relate to patient history and device operation. To display more detailed information about any observation, select the observation and then select the [>>] button.
Review any Patient Alerts listed in the Observations of the Quick Look screen. For the most detailed information about Patient Alerts, select Patient Alert from the Data icon and select [Events].
Check stored episode records for appropriate sensing and detection of arrhythmias. See Section 12.5, page 272.
Check stored SVT episode records for appropriate identification of SVTs.
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Chapter 5
Verifying effective bradycardia pacing
Episode misidentification – If the episode records indicate that false detections have occurred, the Sensing Integrity counter may help in determining the prevalence of oversensing. For more information, see Section 12.3.2, “Sensing integrity counter”, page 268.
If the device is oversensing, consider these programming options:
Increase the Pace Blanking value.
Increase the sensitivity threshold.
Caution: Do not reprogram the device to decrease oversensing without assuring that appropriate sensing is maintained. See Section 6.2, “Setting up sensing”, page 73.
If the episode records reveal that a stable monomorphic VT has been identified and treated as VF, consider these options to improve the detection accuracy:
Review the Interval Plot for the episode, and adjust the VF
Interval, if necessary. Use caution when reprogramming the VF Interval, because changes to this value can adversely affect VF detection.
Consider enabling FVT via VF detection. See Section 6.5,
“Detecting FVT episodes”, page 87.
If the SVT episode records include episodes of true VT, review the SVT episode record to identify the SVT detection criterion that withheld detection. Adjust the SVT detection criteria parameters as necessary. See Section 6.8, “Enhancing detection with PR Logic criteria”, page 98, and Section 6.9, “Enhancing VT detection with the Stability criterion”, page 106.
5.4 Verifying effective bradycardia pacing
To verify that the device is sensing and pacing appropriately, review the following information from the Quick Look screen and investigate as indicated:
Confirm that the patient is receiving adequate cardiac
support for daily living activities.
Review the pacing conduction history for comparison to
the patient history. A sharp increase in the paced beats percentage may indicate a need for investigation and analysis.
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5.4.1 Considerations
Review the following information before verifying bradycardia pacing.
Atrial pacing – If the conduction history shows a predominance of atrial pacing despite a healthy sinus response, consider these options to decrease the atrial pacing burden:
5Conducting a patient follow-up session
Verifying effective bradycardia pacing
Review the recorded Mode Switch episodes for comparison to the patient’s atrial arrhythmia history. A dramatic increase in frequency or duration of atrial episodes may indicate a need for investigation and analysis.
To display more detailed information about the Mode Switch episodes, perform these steps: select Episodes and Counters from the Data icon; select the Mode Switch Episodes from the listed episode counters; then select the [Open Data] button.
Review the Cardiac Compass report for comparison to patient history (see Section 12.9, page 285).
Conduct pacing threshold tests (see Section 13.3, page 299) to verify that the programmed pacing outputs provide a sufficient safety margin.
Decrease the Lower Rate.
Decrease the rate response or increase the activity threshold.
65
Conduction history – If the reported percentages in the conduction history do not add up to 100, the percentages may be rounded. Frequent premature contractions or A: V dissociation may also be the cause.
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Part III
Configuring the device for the patient
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6Detecting tachyarrhythmias
6.1 Detection overview 70
6.2 Setting up sensing 73
6.3 Detecting VF episodes 78
6.4 Detecting VT episodes 81
6.5 Detecting FVT episodes 87
6.6 Detecting tachyarrhythmia episodes with Combined Count 92
6.7 Monitoring episodes for termination or redetection 94
6.8 Enhancing detection with PR Logic criteria 98
6.9 Enhancing VT detection with the Stability criterion 106
6.10 Detecting double tachycardias 108
6.11 Detecting prolonged tachyarrhythmias with High Rate Timeout 109
6
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Chapter 6
Detection overview
6.1 Detection overview
The device detects ventricular tachyarrhythmias (VF, VT, and FVT) by comparing the time intervals between sensed ventricular events to a set of programmable detection intervals. If enough intervals occur that are shorter than the programmed intervals, the device detects a tachyarrhythmia, and responds automatically with a programmed therapy. After delivering the therapy, the device either redetects the arrhythmia and delivers the next programmed therapy or detects episode termination.
To avoid detecting rapidly conducted SVTs (for example, sinus tachycardia or atrial fibrillation) as ventricular tachyarrhythmias, the device provides several detection enhancements, including PR Logic and Stability detection criteria.
All of the detection features interact during initial detection (see Figure 6-1). During redetection, the device does not apply the PR Logic detection criterion.
Note: Detection functions can be turned off by programming the VF Enable, FVT Enable, and VT Enable parameters to Off. For an example, see Section 6.3.4, “How to program VF detection”, page 80.
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6Detecting tachyarrhythmias
Ventricular Event
No
No
No
Yes
Yes
Yes
Yes
Yes
Yes
No
No
No
No
Yes
Yes
Update counts and pattern information
Is the interval in the VF, FVT, or VT detection zone?
Has High Rate Timeout suspended detection enhancements?
Does Stability reset the VT event count? (VT and FVT via VT
detection only)
Has a tachyarrhythmia event count reached an NID?
Are one or more PR Logic criteria on?
No/suspended by High Rate
Timeout
Tachy
Episode
Detected
Is the median ventricular interval less than the SVT Limit?
Is there a double tachycardia in progress?
Are one or more PR Logic criteria withholding detection?
Figure 6-1. How detection features interact during initial detection
71
Detection overview
6.1.1 Suspending tachyarrhythmia detection
When detection is suspended, the device temporarily stops classifying and counting tachyarrhythmia intervals. Sensing and bradycardia pacing remain active, and the programmed detection settings are not modified.
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Chapter 6
Detection overview
Detection is suspended:
when the device senses the presence of a strong magnet.
The programmer head contains a magnet which suspends detection, but once telemetry between the device and programmer is established, detection resumes.
while performing any of the manual system tests, including
Underlying Rhythm, Pacing Threshold, Lead Impedance, EGM Amplitude, and Charge/Dump. Detection automatically resumes once the test is complete.
while performing a T-Shock, 50 Hz Burst, Manual Burst,
or PES Induction. You can choose to have the device automatically resume detection after delivering the induction.
when you deliver a Manual or Emergency therapy. You
can resume detection by selecting the [Resume] button or removing the programming head from the device.
when you select the on-screen [Suspend] button. You can
resume detection by selecting the [Resume] button or by removing the programming head from the device.
during the automatic daily lead impedance measurements.
Detection resumes when the measurements are complete.
while the device is delivering an automatic tachyarrhythmia
therapy (including capacitor charging for defibrillation and cardioversion). However, the device does continue to confirm the detected episode during charging. Detection resumes when the therapy is complete.
Note: The device suspends VT detection (and Combined Count detection; see Section 6.6, page 92) for 17 events following a defibrillation therapy delivered in response to a detected VF.
during charging for Automatic Capacitor Formation.
Detection resumes when charging is complete.
1
1
If the defibrillation therapy is delivered as a result of a High Rate Timeout Therapy operation, VT detection is not suspended (see Section 6.11.4.1, page 111).
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6.2 Setting up sensing
The device provides bipolar sensing in both the atrium and ventricle via the sensing electrodes of the implanted atrial and ventricular leads. You can adjust the sensitivity to intracardiac signals using independent atrial and ventricular sensitivity settings. These settings define the minimum electrical amplitude recognized by the device as an atrial or ventricular sensed event.
Proper sensing is essential for the safe and effective use of the device. To provide appropriate sensing, the device uses:
auto-adjusting atrial and ventricular sensing thresholds
short (30 ms) cross-chamber blanking after paced events
no cross-chamber blanking after sensed events
See details about sensing on Section 6.2.4, page 76.
6.2.1 Parameters
6Detecting tachyarrhythmias
Setting up sensing
73
V. Sensitivity – Minimum amplitude of electrical signal that registers as a sensed ventricular event.
A. Sensitivity – Minimum amplitude of electrical signal that registers as a sensed atrial event.
6.2.2 Considerations
Review the following information before programming sensing parameters.
Dual chamber sensing and bradycardia pacing modes – The device senses in both the atrium and the ventricle at all times, except when the programmed bradycardia pacing mode is DOO or VOO. When the pacing mode is programmed to DOO or VOO mode, there is no sensing in the ventricle. In order to program either DOO or VOO mode, you must first disable detection.
Sensitivity thresholds – The programmed atrial and ventricular sensitivity thresholds apply to all features related to sensing, including detection and bradycardia pacing.
0.15; 0.3
0.6; 0.9; 1.2 mV
0.15; 0.3
0.6; 0.9; 1.2; 1.5;
2.1 mV
; 0.45;
; 0.45;
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Chapter 6
Setting up sensing
Bradycardia pacing and sensing – A combination of high pacing pulse width or high amplitude with a low sensitivity threshold may cause inappropriate sensing across chambers or in the same chamber. Programming a lower pulse width, lower amplitude, longer pace blanking, or a higher sensitivity threshold may eliminate this inappropriate sensing.
Recommended ventricular sensitivity threshold – A ventricular sensitivity threshold of 0.3 mV is recommended to maximize the probability of detecting VF and to limit the possibility of oversensing and cross-chamber sensing.
High ventricular sensitivity threshold – Setting V. Sensitivity to a value greater than 0.6 mV is not recommended except for testing. Doing this may cause undersensing, which can cause any of the following situations:
delayed or aborted cardioversion therapy
delayed defibrillation therapy (when VF confirmation is
active)
asynchronous pacing
underdetection of tachyarrhythmias
Low ventricular sensitivity threshold – If you set V. Sensitivity to its most sensitive value of 0.15 mV, the device will be more susceptible to EMI, cross-chamber sensing, and oversensing.
Recommended atrial sensitivity threshold – An atrial sensitivity threshold of 0.3 mV is recommended to optimize the effectiveness of PR Logic detection criteria and atrial pacing operations, while limiting the possibility of oversensing and cross-chamber sensing.
High atrial sensitivity threshold – If you set the A. Sensitivity value too high, the device may not provide reliable sensing of P-waves during SVTs and sinus rhythm.
Low atrial sensitivity threshold – If you set the A. Sensitivity value to its most sensitive value of 0.15 mV, the device will be more susceptible to EMI, far-field R-wave sensing, and oversensing.
Testing sensitivity after reprogramming – If you change the ventricular sensitivity threshold, evaluate for proper sensing and detection by inducing VF and allowing the device to automatically detect and treat the arrhythmia.
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Atrial pacing and ventricular sensing – If you program the
1
2
3
device to an atrial pacing mode, make sure that it does not sense atrial pacing pulses as ventricular events.
Sensing during VF – Always verify that the device senses properly during VF. If the device is not sensing or detecting properly, program detection and therapies off, and evaluate the system (making sure to monitor the patient for life-threatening arrhythmias until you enable detection and therapies again). You may need to reposition or replace the ventricular sensing lead to achieve proper sensing.
Atrial lead selection – Atrial leads with minimal tip-to-ring spacing may reduce far-field R-wave sensing.
Repositioning the atrial lead – You may need to reposition or replace the atrial sensing lead if reprogramming the atrial sensitivity threshold does not provide reliable atrial sensing during SVTs and sinus rhythm.
6.2.3 How to program sensitivity
6Detecting tachyarrhythmias
Setting up sensing
1. Select Params > Detection.
2. Select the desired A. Sensitivity and V. Sensitivity parameters.
3. Select [PROGRAM].
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A P
V S
A S
V S
A S
V P
Sensitivity Threshold
Rectified and
Filtered A. EGM
Rectified and
Filtered RV EGM
Marker Channel
1
2
3
4
5
Chapter 6
Setting up sensing
6.2.4 Details about sensing
6.2.4.1 Auto-adjusting sensitivity thresholds
The device automatically adjusts the sensitivity thresholds after certain paced and sensed events to help reduce oversensing from T-waves, cross-chamber events, and pacing. You can see how sensitivity thresholds are adjusted after different types of events (see Figure 6-2).
Figure 6-2. Auto-adjusting sensitivity thresholds
1 After an atrial sensed event, the atrial sensitivity threshold increases
to 75% of the EGM peak (maximum: 8x the programmed value, decay constant: 200 ms).
2 After a ventricular sensed event, the ventricular sensitivity threshold
increases to 75% of the EGM peak (maximum: 8x the programmed value, decay constant: 450 ms).
3 After an atrial paced event, the device does not adjust the atrial
sensitivity threshold. The ventricular sensitivity threshold increases by 0.45 mV (decay constant: 60 ms).
4 After a ventricular paced event, the atrial sensitivity threshold
increases to 4x the programmed value (maximum: 1.8 mV, immediate return after 60 ms).
5 After the ventricular pace blanking period is finished, the ventricular
threshold increases to 4.5x the programmed value (maximum:
1.8 mV, decay constant: 450 ms).
2
The exponential decay continues through a subsequent ventricular pacing pulse and its blanking period.
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3
3
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6Detecting tachyarrhythmias
Setting up sensing
6.2.4.2 Blanking periods
During a blanking period, the device does not sense electrical signals. This helps prevent sensing of device pacing, cardioversion and defibrillation pulses, post-pacing depolarization, T-waves, and multiple sensing of the same event. The blanking periods following paced events are longer than those following sensed events to avoid sensing the atrial and ventricular depolarizations.
Notes:
To enhance sensing and detection during tachyarrhythmias,
the device does not apply cross-chamber blanking (blank sensing in the opposite chamber) after a sensed event.
Atrial sensing is still active during the Post-Ventricular
Atrial Blanking (PVAB) period (see Section 8.2.4.4, “Post-Ventricular Atrial Blanking period”, page 159).
The duration of the fixed blanking periods is shown in Table 6-1. For information on programmable pace blanking periods, see Section 8.1, page 148.
Table 6-1. Fixed blanking periods
Cross-chamber blanking after atrial or ventricular pacing pulse
Atrial blanking after sensed atrial event
Ventricular blanking after sensed ventricular event
Atrial and ventricular blanking after delivered cardioversion or defibrillation therapy
30 ms
100 ms
120 ms
520 ms
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6.2.4.3 Refractory periods
During a refractory period, the device senses normally, but classifies sensed events as refractory and limits its response to these events. Pacing refractory periods prevent inappropriately sensed signals, such as far-field R-waves (ventricular events sensed in the atrium) or electrical noise, from triggering certain pacing timing intervals.
3
If the programmed sensitivity value exceeds 0.3 mV (ventricular) or 1.2 mV (atrial), the threshold is not adjusted.
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Chapter 6
Detecting VF episodes
Synchronization refractory periods help prevent the device from delivering cardioversion and defibrillation therapies at inappropriate times. See Section 7.1.5.5, “Synchronizing defibrillation without confirming VF”, page 118 and Section 7.3.5.6, “Synchronizing cardioversion after charging”, page 138.
Note: Refractory periods do not affect tachyarrhythmia detection.
6.3 Detecting VF episodes
The device detects VF episodes by examining the cardiac rhythm for short ventricular intervals. If a predetermined number of intervals occurs that are short enough to be considered VF events, the device detects VF and delivers the first programmed VF therapy. After therapy, the device continues to evaluate the ventricular rhythm to determine if the episode is ongoing.
See Section 6.3.5, “Details about VF detection”, page 80.
6.3.1 Parameters
VF Detection Enable – Turns VF
detection on or off.
VF Interval (Rate) – V-V intervals shorter than this value are counted as VF events.
VF Initial NID – Number of Intervals to Detect: number of VF events the device must count to detect a VF episode.
VF Redetect NID – Number of Intervals to Redetect: number of VF events the device must count to redetect a continuing VF after a therapy.
6.3.2 Considerations
Review the following information before programming VF Detection parameters.
VF Interval minimum setting – To ensure proper VF detection, you should not program the VF Interval less than 300 ms.
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; Off
On
240; 250 … 320 400 ms
12/16; 18/24 30/40; 45/60; 60/80; 75/100; 90/120; 105/140; 120/160
6/8; 9/12; 12/16 21/28; 24/32; 27/36; 30/40
; 24/32;
; 18/24;
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6Detecting tachyarrhythmias
Detecting VF episodes
VF Interval maximum setting – Programming the VF Interval to a value greater than 350 ms may cause inappropriate detection of rapidly conducted atrial fibrillation as VF or FVT via VF. Intervals shorter than the VF Interval are counted using the VF event counter, which is more sensitive than the consecutive VT event counter.
VF, FVT, and VT Intervals – To allow for normal variations in the patient’s tachycardia interval, you should program the VF, FVT, and VT intervals at least 40 ms apart.
Episode redetection – You can expedite redetection by programming the VF and VT Redetect NIDs lower than the Initial NIDs.
Enabling VF detection – When VF Detection Enable is programmed On for the first time, the device
enables Automatic Capacitor Formation
starts recording Cardiac Compass data
starts recording lead performance trends (starting at
3:00 AM, by the device clock)
clears all brady pacing counters
VF detection and PR Logic criteria – You can program the device to exclude rapidly conducted SVTs from VF Detection by enabling the PR Logic detection criteria. Note that the SVT Limit must be programmed shorter than the VF Interval in order for the PR Logic criteria to affect VF detection. See Section 6.8, “Enhancing detection with PR Logic criteria”, page 98.
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6.3.3 Restrictions
Double tachycardia detection – When any PR Logic detection
criteria are enabled, the device also enables double tachycardia detection (VF, VT, or FVT in the presence of an SVT). See Section 6.10, “Detecting double tachycardias”, page 108.
Review the following information before programming VF Detection parameters.
Tachyarrhythmia detection and bradycardia pacing – To ensure reliable ventricular tachyarrhythmia detection, the programmer regulates the values available for bradycardia pacing and tachyarrhythmia detection. See Section B.11, “Parameter interlocks”, page 361.
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1
2
3
Chapter 6
Detecting VF episodes
VF detection backup – To ensure VF Detection backup during VT and FVT episodes, if VF Detection is off, both VT Detection and FVT Detection must also be off.
6.3.4 How to program VF detection
1. Select Params > Detection.
2. Select the desired values for VF Enable, VF Initial NID, VF Redetect NID, and VF Interval.
3. Select [PROGRAM].
6.3.5 Details about VF detection
The device detects VF by counting the number of VF events, which are V-V intervals shorter than the programmed VF Interval. On each event, the device counts the number of recent VF events. The number of recent events examined is called the VF detection window. The size of the VF detection window is the second number in the programmed VF NID (for example, 24 events if the VF Initial NID is 18/24).
The threshold for detecting VF is the first number in the programmed VF NID (for example, 18 events if the VF Initial NID is 18/24). This threshold is always 75% of the VF detection window. That is, if 75% of the events in the VF detection window are VF events, the device detects a VF episode (see Figure 6-3).
After the device detects VF, it delivers the first programmed VF therapy. Following the therapy, if the number of VF events reaches the programmed VF Redetect NID, the device redetects
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VF and delivers the next programmed VF therapy.
Note: The device can also detect VF Episodes via the Combined Count detection criterion (see Section 6.6, page 92).
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Figure 6-3. Device detects VF
A S
A S
V S
V S
V S
V S
V S
V S
V S
A R
A R
A R
A R
A R
1 2 3 4 5 6 6 7 8 9 10 11 12 13 141516 17 18
F S
F S
F S
F S
F S
F S
F S
F S
F S
F S
F S
F S
F S
F S
F S
F S
F S
F D
200 ms
2
3
1
VF Event Count
ECG
Marker Channel
VF Interval
1 VF starts, and the device begins counting VF events (intervals less
than the programmed VF Interval).
2 A ventricular interval occurs outside the VF detection zone. The VF
event count is not incremented.
3 The VF event count reaches the programmed VF NID value of 18
events out of 24, and the device detects VF.
6Detecting tachyarrhythmias
Detecting VT episodes
81
6.4 Detecting VT episodes
The device detects VT episodes by examining the cardiac rhythm for short ventricular intervals. If enough intervals occur that are short enough to be considered VT events (but are not VF or FVT events), the device detects VT and delivers the first programmed VT therapy. After therapy, the device continues to evaluate the ventricular rhythm to determine if the episode is ongoing.
You can program the device to detect and record VT episodes without treating them with VT therapies by setting VT Detection Enable to Monitor. If a patient’s VT episodes are well-tolerated, this feature allows you to collect data about these episodes without delivering therapy or affecting VF detection.
See Section 6.4.5, “Details about VT detection”, page 83.
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Chapter 6
Detecting VT episodes
6.4.1 Parameters
VT Detection Enable – Turns VT
detection on or off, or enables VT monitoring.
VT Interval (Rate) – V-V intervals shorter than this value are counted as VT events.
VT Initial NID – Number of Intervals to Detect: number of VT events the device must count to detect a VT episode.
VT Redetect NID – Number of Intervals to Redetect: number of VT events the device must count to redetect a continuing VT after a therapy.
6.4.2 Considerations
Review the following information before programming VT Detection parameters.
VF, FVT, and VT Intervals – To allow for normal variations in the patient’s tachycardia interval, you should program the VF, FVT, and VT intervals at least 40 ms apart.
Episode redetection – You can expedite redetection by programming the VF and VT Redetect NIDs lower than the Initial NIDs.
On; Off
280; 290 … 400
12; 16
4; 8; 12
; or Monitor
…52; 76; 100
… 52
… 600 ms
VT Detection Enable, AFib/AFlutter, and Sinus Tach – When you set VT Detection Enable to On or Monitor, the AFib/AFlutter and Sinus Tach parameters are also automatically set to On.
VT detection and Combined Count detection – When VT Detection is On, the device applies the Combined Count detection criterion to help speed detection of rhythms that fluctuate between detection zones. Combined Count detection is disabled if VT Detection is set to Off or Monitor. See Section 6.6, “Detecting tachyarrhythmia episodes with Combined Count”, page 92.
VT detection and rapidly conducted SVTs – You can program the device to exclude rapidly conducted SVTs from VT detection by enabling the PR Logic or Stability detection criteria. See Section 6.9, “Enhancing VT detection with the Stability criterion”, page 106, and Section 6.8, “Enhancing detection with PR Logic criteria”, page 98.
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Double tachycardia detection – When any PR Logic detection
1
2
3
criteria are enabled, the device also enables double tachycardia detection (VF, VT, or FVT in the presence of an SVT; see Section 6.10, page 108).
6.4.3 Restrictions
Review the following information before programming VT detection parameters.
Tachyarrhythmia detection and bradycardia pacing – To ensure reliable ventricular tachyarrhythmia detection, the programmer regulates the values available for bradycardia pacing and tachyarrhythmia detection. See Section B.11, “Parameter interlocks”, page 361.
VF detection backup – To ensure VF detection backup during VT and FVT episodes, if VF Detection is off, both VT Detection and FVT Detection must also be off.
6.4.4 How to program VT detection
6Detecting tachyarrhythmias
Detecting VT episodes
1. Select Params > Detection.
2. Select the desired values for VT Enable, VT Initial NID, VT Redetect NID, and VT Interval.
3. Select [PROGRAM].
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6.4.5 Details about VT detection
The device detects VT by counting the number of consecutive VT events. A VT event is a V-V interval shorter than the programmed VT Interval but greater than or equal to the VF Interval. If the number of consecutive VT events reaches the programmed VT Initial NID, the device detects VT (see Figure 6-4).
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Detecting VT episodes
The VT event count resets to zero whenever an interval occurs that is greater than or equal to the programmed VT Interval. The count remains at the current value if an interval is shorter than the programmed VF Interval.
After the device detects VT, it delivers the first programmed VT therapy. Following the therapy, if the VT event counter reaches the VT Redetect NID, the device redetects VT and delivers the next programmed therapy.
Note: The device can also detect VT Episodes via the Combined Count detection criterion (see Section 6.6, page 92).
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Figure 6-4. Device detects VT
A S
A S
V S
V S
V S
V S
A R
A R
A R
A R
A R
A R
A R
1 0 1 2 3 4 5 6
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T S
T S
T S
T S
T S
T S
V S
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A R
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A R
A R
A R
A R
A R
A R
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A R
7 8 9 10 11 12 13 14 15 16
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T S
T S
T S
T S
T S
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T D
2
1
3
VT Event Count
ECG
Marker Channel
VT Interval
VT Event Count
ECG
Marker Channel
VT Interval
6Detecting tachyarrhythmias
Detecting VT episodes
85
1 VT starts, and the device begins counting VT events (intervals less
than the programmed VT Interval, but greater than or equal to the VF Interval).
2 A ventricular interval occurs outside VT detection zone. The VT event
count resets to zero.
3 The VT event count reaches the programmed VT NID of 16 events,
and the device detects VT.
6.4.5.1 VT monitoring
You can program the device to record VT episodes without delivering VT therapy by setting VT Detection to Monitor. When VT monitoring is enabled, the device detects VT episodes but does not deliver VT therapy (see Figure 6-5). Instead, it records VT episodes, labeling them as “monitored,” and waits for episode termination to occur.
When VT Detection is set to Monitor, several detection operations work differently.
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Detecting VT episodes
VT event counting – Before the device detects an episode, it counts VT events normally. However, once the VT Initial NID is reached, the device sets the VT event count to zero and suspends VT event counting for the rest of the episode.
VF and FVT detection – VF and FVT detection operate as if VT detection is off. Specifically, Combined Count detection is disabled, and FVT via VT detection is not selectable. If a monitored VT episode accelerates into the FVT or VF detection zone, the device applies the VF Initial NID to detect the new tachyarrhythmia. Once an episode is in progress, VT event counting doesn’t resume until the episode ends.
Caution: Programming the VF Interval greater than 350 ms may result in inappropriate detection of rapidly conducted atrial fibrillation as VF or FVT via VF. Intervals shorter than the VF Interval are counted using the VF event counter, which is more sensitive than the consecutive VT event counter.
PR Logic and Stability criteria – Before the device detects a tachyarrhythmia episode, the PR Logic and Stability criteria, if turned on, are applied. If a monitored VT episode accelerates into the FVT or VF detection zone, the device continues to apply PR Logic criteria as initial VF or FVT detection begins. However, because the Stability feature does not affect VF detection or FVT via VF detection, it is not applied.
Episode termination – The device compares ventricular intervals to the VT Interval to identify when a VT monitored episode has ended. However, if a VF episode or FVT via VF episode occurs when VT monitoring is enabled, the device compares ventricular intervals to the VF Interval to identify episode termination.
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Figure 6-5. Device detects and monitors VT
200 ms
1 2 3 4
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A R
A RA RA
R
V S
V ST ST ST ST
S
13 14 15 16 0 0 0
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A RA RA RA RA
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T ST ST ST DT ST ST
S
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1
VT Event Count
ECG
Marker Channel
VT Interval
1 VT starts, and the device begins counting VT events (intervals less
than the programmed VT Interval but greater than or equal to the VF Interval).
2 The VT event count reaches the programmed VT NID of 16 events,
and the device detects VT.
3 After detecting the VT episode, the device resets the VT event count
to zero and monitors the episode until termination.
6Detecting tachyarrhythmias
Detecting FVT episodes
87
6.5 Detecting FVT episodes
The device detects episodes of Fast Ventricular Tachycardia (FVT) by examining the cardiac rhythm for short ventricular intervals. If enough intervals occur in the programmed FVT detection zone, the device detects FVT and delivers the first programmed FVT therapy. After therapy, the device continues to evaluate the ventricular rhythm to determine if the episode is ongoing. To make sure it delivers sufficiently aggressive therapies, the device can merge the programmed detection zones during redetection to increase sensitivity.
See Section 6.5.5, “Details about FVT detection”, page 90.
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6.5.1 Parameters
FVT Detection Enable – Enables FVT
detection via the VF or the VT detection algorithm.
FVT Interval (Rate) – V-V intervals between this value and the programmed VF Interval are marked as FVT events.
6.5.2 Considerations
Review the following information before programming FVT Detection parameters.
VF, FVT, and VT Intervals – To allow for normal variations in the patient’s tachycardia interval, you should program the VF, FVT, and VT intervals at least 40 ms apart.
Episode redetection – You can expedite redetection by programming the VF and VT Redetect NIDs lower than the Initial NIDs.
FVT detection enable – Your choice for an appropriate setting for FVT Detection should depend on the patient’s VF and VT cycle lengths. After determining a reliably sensitive VF Interval, consider the following suggestions:
; via VF; or via
Off VT
200; 210 … 600 ms
If the patient presents with a clinical VT interval in the VF zone, select via VF to ensure reliable detection of VF. (VT Detection need not be enabled at all.)
If the patient presents with two clinical VTs, both outside the
VF zone, select via VT to allow for correct classification of the faster VT and to offer a separate therapy regimen for each VT.
If the patient presents with only one clinical VT which is
outside the VF zone, select VF and VT Detection only, and set FVT Enable to Off.
FVT detection and PR Logic criteria – You can program the device to exclude rapidly conducted SVTs from FVT Detection by enabling the PR Logic detection criteria. Note that the SVT Limit must be programmed shorter than the VF Interval for the PR Logic criteria to affect FVT via VF detection.
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6.5.3 Restrictions
6Detecting tachyarrhythmias
Detecting FVT episodes
Double tachycardia detection – When any PR Logic detection criteria is enabled, the device also enables double tachycardia detection (VF, VT, or FVT in the presence of an SVT, see Section 6.10, page 108).
Review the following information before programming FVT Detection parameters.
Tachyarrhythmia detection and bradycardia pacing – To ensure reliable ventricular tachyarrhythmia detection, the programmer regulates the values available for bradycardia pacing and tachyarrhythmia detection. See Section B.11, “Parameter interlocks”, page 361.
VF detection backup – To ensure VF Detection backup during VT and FVT episodes, VT and FVT Detection cannot be on unless VF Detection is also on.
FVT detection – To ensure reliable ventricular tachyarrhythmia detection, the programmer regulates the values available for the FVT parameter as follows:
VT Detection must be set to On if FVT Detection is set to
via VT.
89
If FVT Detection is set to via VF, the FVT Interval must be
programmed to a value shorter than the VF Interval.
If FVT Detection is set to via VT, the FVT Interval must be
programmed to a value greater than the VF Interval and less than or equal to the VT Interval.
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Detecting FVT episodes
6.5.4 How to program FVT detection
6.5.5 Details about FVT detection
You can program the device to detect FVT episodes via the VF or VT detection zone and NID.
1. Select Params > Detection.
2. Select the desired values for FVT Enable and FVT Interval.
3. Select [PROGRAM].
When FVT Detection is set to via VF, a V-V interval within the FVT detection zone is marked as an “FVT via VF” event. When the VF NID is reached, the device reviews the last eight intervals:
If any of the last eight intervals are in the VF zone, it detects
the episode as VF.
If all of the last eight intervals are outside the VF zone, it
detects the episode as FVT (see Figure 6-6).
When FVT Detection is set to via VT, a V-V interval within the FVT detection zone is marked as an “FVT via VT” event. When the VT NID is reached, the device reviews the last eight intervals:
If any of the last eight intervals are in the VF or FVT zones, it
detects the episode as FVT.
If all of the last eight intervals are outside the FVT and VF
zones, it detects the episode as VT.
Note: The device can also detect FVT episodes via the Combined
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Count detection criterion (see Section 6.6, page 92).
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Figure 6-6. Device detects FVT via VF
200 ms
13 14 15 16 17 18
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R
T FT
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VF Event Count
ECG
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VF and FVT Intervals
1 A fast ventricular tachycardia starts, and the first event falls into the
FVT detection zone.
2 The second event of the FVT episode has an interval that falls into
the VT zone. The VF event count is not incremented.
3 The device detects FVT after the VF event count reaches the VF
Initial NID.
6Detecting tachyarrhythmias
Detecting FVT episodes
91
6.5.5.1 Zone merging after detection
To ensure that the device delivers sufficiently aggressive therapies during an extended or highly variable tachyarrhythmia episode, the device merges detection zones during redetection in some instances, as shown in Figure 6-7. The merged zone configuration uses the event counting and therapies for the faster arrhythmia and remains in effect until episode termination.
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Before detection
After VF detection
After FVT detection
FVT set to “via VF”
VF and FVT zones merge, leaving a larger VF zone.
All zones remain unchanged.
FVT set to “via VT”
VT and FVT zones merge, leaving a larger FVT zone.
VT and FVT zones merge, leaving a larger FVT zone.
Detection Intervals: VF Interval: 320 ms, FVT Interval: 280 ms / 360 ms, VT Interval: 400 ms
VF
FVT
VT
VF
FVT
VT
VF
FVT
VT
VF
FVT
VT
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VF
FVT
VT
Chapter 6
Detecting tachyarrhythmia episodes with Combined Count
Figure 6-7. FVT zone merging
6.6 Detecting tachyarrhythmia episodes with Combined Count
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Because the device counts VF and VT events separately, rhythms with variable cycle lengths can cause both event counts to increment during an episode. To prevent these rhythms from delaying detection, the device automatically enables the Combined Count detection criterion if both VF and VT detection are programmed On.
The Combined Count criterion compares the sum of the VF and VT event counts to the Combined Number of Intervals to Detect (CNID), which the device calculates automatically from the programmed VF NID values. If the CNID is met, the device reviews the recent intervals to determine if the episode should be treated as a VF, FVT, or VT episode. The Combined Count criterion applies during both initial detection and redetection.
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Detecting tachyarrhythmia episodes with Combined Count
6.6.1 Details about Combined Count detection
The Combined Count detection algorithm expedites detection or redetection of ventricular tachyarrhythmias with ventricular intervals that fluctuate between the VF and VT detection zones. When VT detection is on, the device applies Combined Count detection, which tracks the combined number of VT and VF events counted. If this sum reaches the Combined Number of Intervals to Detect (CNID), the device detects VF, FVT, or VT. Combined Count detection also applies to redetected episodes.
Note: Combined Count detection is off when VT detection is set to Monitor or Off.
If the VF event counter reaches six, the device automatically applies the Combined Number of Intervals to Detect (CNID). The CNID is calculated by multiplying the current VF NID (Initial or Redetect) by 7/6 and rounding down. Table 6-2 shows the CNID values that correspond to each VF NID value.
Table 6-2. CNID values for each initial or redetect VF NID value
VF NID CNID VF NID CNID
6/8
9/12
12/16
18/24
7
10
14
21
6Detecting tachyarrhythmias
21/28
24/32
27/36
30/40
24
28
31
35
93
Combined Count detection is fulfilled when the sum of the VF and VT event counts equals or exceeds the CNID. The device then reviews the last eight intervals and classifies the episode as
VF, if any of the last eight were in the VF zone.
FVT, if FVT Detection is enabled and none of the last eight
was in the VF zone, but one or more was in the FVT zone.
VT, if all eight were outside the VF zone (and FVT zone, if
FVT detection is enabled).
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200 ms
A SA RA RA RA RA RA RA RA RA RA RA RA
R
A RA RA RA RA RA RA RA
R
A R
V SV SF
S
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1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17
1 2 3 4
1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21
VF Event Count
VT Event Count
Combined Count
VF and VT Interval
ECG
Marker Channel
1
2
3
Chapter 6
Monitoring episodes for termination or redetection
Figure 6-8. Device detects VF with the Combined Count criterion
1 A slow VF episode starts, with a ventricular cycle length that varies
between the VF and VT detection zones.
2 When a VT event occurs, the device increments the VT event count
and the Combined Count.
3 The device detects VF even though the VF event count hasn’t yet
reached the VF Initial NID (18/24 in this example). The Combined Count reaches the CNID value of 21 first.
6.7 Monitoring episodes for termination or redetection
Once the device detects an arrhythmia, it considers the episode
INTRINSIC™/INTRINSIC™30 7288/7287 Reference Manual
ongoing until it detects that the episode has ended. After delivering therapy, it monitors the ventricular rhythm using the programmed Redetect NIDs. If one of these NIDs is met, the device delivers the next programmed therapy for the detected arrhythmia.
See Section 6.7.4, “Details about episode termination and redetection”, page 95.
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6.7.1 Parameters
1
3
2
6Detecting tachyarrhythmias
Monitoring episodes for termination or redetection
95
VF Redetect NID – Number of Intervals to Redetect: number of VF events the device must count to redetect a continuing VF after a therapy.
VT Redetect NID – Number of Intervals to Redetect: number of VT events the device must count to redetect a continuing VT after a therapy.
6.7.2 Considerations
Review the following information before programming redetection parameters.
Initial and Redetect NIDs – You can expedite redetection by programming the VF and VT Redetect NIDs lower than the Initial NIDs.
6.7.3 How to program redetection parameters
6/8; 9/12; 12/16 21/28; 24/32; 27/36; 30/40
4; 8; 12
1. Select Params > Detection.
2. Select the desired values for VT Redetect NID and VF Redetect NID.
3. Select [PROGRAM].
… 52
; 18/24;
6.7.4 Details about episode termination and redetection
After a therapy is delivered, the device evaluates the ventricular rhythm to determine if the episode has terminated, is continuing, or has changed to a different arrhythmia.
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Monitoring episodes for termination or redetection
6.7.4.1 Episode termination
The device determines that the episode has terminated if one of the following conditions occurs:
8 consecutive ventricular intervals are greater than or equal
to the programmed VT interval.
20 s elapse with no ventricular intervals shorter than the
programmed VT interval.
After antitachycardia pacing therapy, the device begins evaluating intervals for episode termination on the first ventricular cycle. After cardioversion or defibrillation, the device begins evaluating intervals for episode termination on the second ventricular event. (Due to the extended post shock blanking, this event may be the
third event on the electrogram.)
Note: Any subsequent detection after the end of the episode
marks the start of a new episode.
6.7.4.2 Episode redetection
After the device detects a tachyarrhythmia episode and delivers a therapy, the device redetects an arrhythmia if the VF or VT event count reaches the Redetect NID or if the combined VF and VT event count reaches the Redetect CNID (see Section 6.6, “Detecting tachyarrhythmia episodes with Combined Count”, page 92).
4
4
The device then delivers the next programmed therapy for the current arrhythmia and resumes monitoring for the outcome of that therapy (see Figure 6-9).
4
VF interval if VT Detection is set to Off or Monitor, and the episode is a VF or an FVT via VF episode.
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Monitoring episodes for termination or redetection
A RA SA SA SA SA SA RA RA RA RA RA RA RA RA RA RA RA RA
R
T P
T PT
P
T PT DT PT PT PT PT PT ST ST ST ST ST ST ST ST ST ST ST
D
200 ms
016 0 1 2 3 4 5 6 7 8 9 10 11 12
3
2
1
VT Event Count
ECG
Marker Channel
VT Interval
Figure 6-9. VT episode redetected after therapy
1 A VT episode is detected, and the device delivers a Burst ATP therapy. 2 After therapy, the device continues to detect events in the VT zone. 3 When the VT event count reaches the VT Redetect NID, the device
redetects the VT.
Notes:
The device suspends VT detection (and Combined Count
detection) for 17 events following a defibr illation therapy delivered in response to a detected VF. detection helps avoid detecting transient VTs that can follow high voltage therapies.
The PR Logic criteria are not applied during redetection.
However, the Stability criterion may withhold detection or redetection of VT (or FVT via VT) throughout an episode.
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Suspending VT
97
6.7.4.3 VT acceleration
If the device redetects VT, it classifies the rhythm as accelerated if the average of the four intervals before redetection is at least 60 ms less than the average of the four intervals before initial VT detection. The most recent interval average is used to identify VT acceleration if VT is redetected again during the episode.
5
If the defibrillation therapy is delivered as a result of a High Rate Timeout “Skip to VF Therapy” operation, VT detection is not suspended (see Section 6.11.4.1, page 111).
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If the device redetects VF or an accelerated VT after an antitachycardia pacing sequence delivery, it skips the subsequent pacing therapy sequences for the duration of the episode and delivers the next therapy programmed for the current arrhythmia.
6.8 Enhancing detection with PR Logic criteria
The PR Logic detection criteria are designed to withhold inappropriate ventricular detection during episodes of rapidly conducted supraventricular tachycardia (SVT). The device analyzes the activation patterns and timing in both chambers using PR Logic pattern and rate analysis. This information helps identify evidence of atrial fibrillation, atrial flutter, sinus tachycardia, and other 1:1 SVTs. If this analysis indicates the presence of one or more of these rhythms, the device withholds detection.
For more information, see
Section 6.8.5, “Details about PR Logic pattern and rate
analysis”, page 101
Section 6.8.6, “Details about the PR Logic detection
criteria”, page 105
6.8.1 Parameters
AFib/AFlutter – Identifies rapidly conducted
atrial fibrillation, atrial flutter, or atrial tachycardia
Sinus Tach – Identifies sinus tachycardia
1:1 VT-ST Boundary – Threshold between
the retrograde and antegrade zones used by A-V pattern analysis. Allows customizing of the Sinus Tach criterion for patients with slow one-to-one conduction.
Other 1:1 SVTs – Identifies other one-to-one SVTs where the atrial and ventricular activation are roughly simultaneous
SVT Limit – Defines the minimum ventricular interval at which the device applies the PR Logic criteria
a
When you set VT Detection Enable to On or Monitor, the AFib/AFlutter and Sinus Tach parameters are also automatically set to On.
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Ona; Off
Ona; Off
35; 50
On; Off
240; 250 … 320 330; 340 … 600 ms
; 66; 75; 85%
;
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6.8.2 Considerations
Review the following information before programming PR Logic parameters.
PR Logic criteria and double tachycardia detection – When any of the PR Logic criteria are enabled, the device also enables double tachycardia detection (VF, VT, or FVT in the presence of an SVT; see Section 6.10.1, page 108).
6Detecting tachyarrhythmias
Enhancing detection with PR Logic criteria
Cautions:
Before enabling the Other 1:1 SVTs criterion, ensure
that the atrial lead has matured. This criterion could inappropriately withhold therapy if atrial sensing is compromised by an unstable or dislodged atrial lead.
Use caution when programming the Other 1:1 SVTs
criterion in patients who exhibit slow 1:1 retrograde conduction during VF or VT. This criterion could inappropriately withhold VF/VT therapy in such patients. See Section 6.8.5.1, “Pattern analysis of A-V and V-A intervals”, page 102.
Use caution when programming the 1:1 VT-ST
Boundary. Incorrect programming of this parameter can result in inappropriate therapies or underdetection of tachyarrhythmias.
99
Sinus Tach and 1:1 VT-ST Boundary – When enabling the Sinus Tach criterion in patients who exhibit slow 1:1 retrograde conduction during VF or VT or slow antegrade conduction during SVTs, make sure to set the 1:1 VT-ST Boundary parameter appropriately. See Section 6.8.2.1, “Customizing PR Logic for patients with slow conduction”, page 100.
VT Detection Enable, AFib/AFlutter and Sinus Tach – When you set VT Detection Enable to On or Monitor, the AFib/AFlutter and Sinus Tach parameters also automatically set to On.
SVT Limit – To ensure that therapy is delivered for hemodynamically compromising rates of any origin, the device always delivers therapy when the median ventricular interval is less than the programmed SVT Limit (nominally 320 ms) if VT, VF, or FVT detection criteria are satisfied.
VF Interval and SVT Limit – If you program an SVT Limit greater than the VF Interval, you are effectively disabling the PR Logic criteria for VF detection.
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6.8.2.1 Customizing PR Logic for patients with slow conduction
Slow antegrade conduction during an SVT or slow 1:1 retrograde conduction during VT can adversely affect the accuracy of the Sinus Tach and Other 1:1 SVTs criteria. The 1:1 VT-ST Boundary parameter allows you to customize the Sinus Tach criterion for patients who exhibit slow conduction.
Note: Changing the 1:1 VT-ST Boundary parameter does not affect the operation of the Other 1:1 SVTs criterion. Use caution when enabling this criterion in patients who exhibit slow antegrade or retrograde conduction.
The 1:1 VT-ST Boundary parameter represents an A-V interval that is a percentage of a V-V interval. This value separates the retrograde and antegrade zones used by PR Logic pattern analysis operations. See Section 6.8.5.1, “Pattern analysis of A-V and V-A intervals”, page 102.
If slow retrograde or antegrade conduction causes events to occur in the incorrect zone, you can use the 1:1 VT-ST Boundary parameter to increase the size of the appropriate zone. See Figure 6-10, page 102 .
If a patient exhibits slow antegrade or retrograde conduction and could benefit from a different 1:1 VT-ST Boundary setting, choose a new setting as follows:
If the patient exhibits long V-A intervals during VT with 1:1
retrograde conduction, select 35%.
If the patient exhibits long A-V intervals during an SVT, select
a value that exceeds the A-V/V-V ratio observed during stored VT/VF or SVT episodes. See Section 12.5.3.1, “EGM Strip”, page 277.
6.8.3 Restrictions
Review the following information before programming PR Logic parameters.
Sinus Tach and 1:1 VT-ST Boundary – The Sinus Tach criterion must be on before 1:1 VT-ST Boundary can be selected.
VT Detection Enable and SVT Limit – The SVT Limit must be shorter than the VT Interval (or VF Interval if VT Detection is off).
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