Medtronic D154VRC Reference Guide
ENTRUST® D154ATG, D154DRG,
D154VRC
Implantable Cardioverter Defibrillator systems
Reference Manual
Caution: Federal law (USA) restricts this device to sale by or on the order of a physician.
ENTRUST® D154ATG, D154DRG,
D154VRC
Reference Manual
A guide to the operation and programming of the EnTrust Implantable Cardioverter Defibrillator
systems
The following list includes trademarks or registered trademarks of Medtronic in the
United States and possibly in other countries. All other trademarks are the property
of their respective owners.
ATP During Charging, Active Can, Cardiac Compass, CareLink, ChargeSaver,
Checklist, EnTrust, Flashback, InCheck, Intrinsic, MVP, Marker Channel,
Medtronic, Medtronic CareLink, PR Logic, Patient Alert, Quick Look, QuickLink,
Reactive ATP, Switchback, T-Shock
Medtronic ENTRUST
®
D154ATG, D154DRG, D154VRC
Contents
Introduction .............................................................. 11
Part I Quick overview ......................................... 14
1 Quick reference ................................................... 14
1.1 Physical characteristics, AT and DR devices ............................ 14
1.2 Physical characteristics, VR devices ................................... 15
1.3 Replacement indicators .............................................. 16
1.4 Longevity projections ................................................ 17
1.5 Magnet application .................................................. 19
1.6 Typical charge times ................................................ 19
1.7 High-voltage therapy energy .......................................... 20
1.8 Stored data and diagnostics .......................................... 21
2 The EnTrust system ............................................... 26
2.1 System overview .................................................... 26
2.2 Indications and usage, AT devices .................................... 29
2.3 Indications and usage, DR and VR devices ............................. 30
2.4 Contraindications, AT devices ........................................ 30
2.5 Contraindications, DR and VR devices ................................. 30
2.6 Patient screening ................................................... 31
3 Emergency therapy ................................................ 32
3.1 Overview of emergency therapies ..................................... 32
3.2 Delivering an emergency defibrillation therapy .......................... 33
3.3 Delivering an emergency cardioversion therapy ......................... 34
3.4 Delivering emergency fixed burst pacing ............................... 35
3.5 Enabling emergency VVI pacing ...................................... 37
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Part II Device implant and patient follow-up
procedures ...................................................... 39
4 Implanting the device .............................................. 39
4.1 Overview .......................................................... 39
4.2 Considerations ..................................................... 39
4.3 Preparing for an implant ............................................. 40
4.4 Verify lead and connector compatibility ................................. 41
4.5 Position the leads ................................................... 42
4.6 Test the lead system ................................................ 43
4.7 Connect the leads to the device ....................................... 44
4.8 Testing ventricular defibrillation operation and effectiveness .............. 47
4.9 Position and secure the device ........................................ 51
4.10 Completing the implant procedure ..................................... 53
4.11 Replacing a device .................................................. 54
4.12 Optimizing device longevity .......................................... 55
5 Conducting a patient follow-up session ............................. 57
5.1 Patient follow-up guidelines .......................................... 57
5.2 Verifying the status of the implanted system ............................ 57
5.3 Optimizing charge time .............................................. 58
5.4 Verifying accurate detection and appropriate therapy .................... 62
5.5 Verifying effective bradycardia pacing ................................. 63
Part III Configuring the device for the patient .......... 65
6 Detecting tachyarrhythmias ........................................ 65
6.1 Detection overview .................................................. 65
6.2 Setting up sensing .................................................. 70
6.3 Detecting atrial tachyarrhythmias ...................................... 78
6.4 Detecting VF episodes ............................................... 84
6.5 Detecting VT episodes ............................................... 88
6.6 Detecting FVT episodes ............................................. 92
6.7 Monitoring VT episodes .............................................. 96
6.8 Detecting tachyarrhythmia episodes with combined count ............... 101
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6.9 Determining episode termination or redetection ........................ 103
6.10 Enhancing detection with PR Logic criteria ............................ 107
6.11 Enhancing detection with Wavelet .................................... 114
6.12 Enhancing VT detection with the Onset criterion ........................ 122
6.13 Enhancing VT detection with the Stability criterion ...................... 126
6.14 Detecting double tachycardias ....................................... 129
6.15 Detecting prolonged tachyarrhythmias with High Rate Timeout ........... 129
7 Treating tachyarrhythmia episodes ................................ 133
7.1 Controlling atrial therapy sequencing ................................. 133
7.2 Treating atrial arrhythmias with cardioversion .......................... 142
7.3 Providing patient-activated atrial cardioversion ......................... 150
7.4 Treating atrial arrhythmias with antitachycardia pacing .................. 153
7.5 Treating episodes detected as VF .................................... 162
7.6 Treating VT and FVT with antitachycardia pacing ....................... 176
7.7 Treating VT and FVT with ventricular cardioversion ..................... 183
7.8 Optimizing ventricular ATP therapy with Smart Mode .................... 191
7.9 Optimizing therapy with Progressive Episode Therapies ................. 194
8 Treating bradycardia ............................................. 198
8.1 Providing basic pacing therapy ...................................... 198
8.2 Dual chamber pacing ............................................... 202
8.3 Single chamber pacing ............................................. 214
8.4 MVP (Managed Ventricular Pacing) .................................. 220
8.5 Rate Response .................................................... 225
8.6 Rate Adaptive AV .................................................. 232
8.7 Rate Hysteresis .................................................... 236
8.8 Mode Switch ...................................................... 240
8.9 Non-Competitive Atrial Pacing ....................................... 242
8.10 PMT Intervention .................................................. 247
8.11 PVC Response .................................................... 250
8.12 Ventricular Safety Pacing ........................................... 253
8.13 Atrial Rate Stabilization ............................................. 256
8.14 Atrial Preference Pacing ............................................ 259
8.15 Post Mode Switch Overdrive Pacing (PMOP) .......................... 264
8.16 Ventricular Rate Stabilization (VRS) .................................. 266
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8.17 Post VT/VF Shock Pacing ........................................... 269
8.18 Post Shock Pacing ................................................. 271
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D154ATG, D154DRG, D154VRC
Part IV Evaluating and managing patient treatment .. 275
9 Using the programmer ............................................ 275
9.1 Setting up and using the programmer ................................. 275
9.2 Display screen features ............................................. 277
9.3 Streamlining follow-up and implant sessions with Checklist .............. 282
9.4 Viewing and programming device parameters .......................... 289
9.5 Saving and retrieving a set of parameter values ........................ 292
9.6 Starting and ending patient sessions .................................. 295
9.7 Viewing live waveform traces ........................................ 299
9.8 Recording live waveform strips ....................................... 307
9.9 Freezing and analyzing a waveform strip .............................. 309
9.10 Recalling and viewing waveform strips ................................ 310
9.11 Saving and retrieving device data .................................... 311
9.12 Printing reports .................................................... 315
10 Setting up and viewing collected data .............................. 323
10.1 A summary of data collection ........................................ 323
10.2 Setting up data collection ........................................... 324
10.3 Viewing Quick Look data ............................................ 331
10.4 Using the Patient Alert feature ....................................... 335
10.5 Viewing Arrhythmia Episode data .................................... 342
10.6 Viewing Flashback Memory data ..................................... 354
10.7 Using Cardiac Compass to view long-term clinical trends ................ 356
10.8 Using Rate Histograms reports ...................................... 363
10.9 Viewing the counters ............................................... 367
10.10 Viewing Battery and Lead Measurement data .......................... 374
10.11 Viewing Lead Performance Trends data ............................... 377
10.12 Viewing and entering patient information .............................. 381
10.13 Automatic device status monitoring ................................... 383
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11 Testing the system ............................................... 386
11.1 System test overview ............................................... 386
11.2 Evaluating the underlying rhythm ..................................... 387
11.3 Measuring pacing thresholds ........................................ 388
11.4 Testing the Wavelet criterion ........................................ 391
11.5 Measuring lead impedance .......................................... 396
11.6 Performing a Sensing Test .......................................... 398
11.7 Testing the device capacitors ........................................ 400
12 Conducting electrophysiologic studies ............................ 404
12.1 EP Study overview ................................................. 404
12.2 Inducing VF with T-Shock ........................................... 405
12.3 Inducing VF with 50 Hz Burst ........................................ 408
12.4 Delivering an atrial 50 Hz Burst ...................................... 411
12.5 Inducing an arrhythmia with Fixed Burst ............................... 414
12.6 Inducing an arrhythmia with PES ..................................... 417
12.7 Delivering a manual therapy ......................................... 420
13 Solving system problems ......................................... 425
13.1 Overview ......................................................... 425
13.2 Solving sensing problems ........................................... 425
13.3 Solving atrial tachyarrhythmia detection problems ...................... 427
13.4 Solving ventricular tachyarrhythmia detection problems ................. 428
13.5 Solving atrial tachyarrhythmia therapy problems ........................ 429
13.6 Solving ventricular tachyarrhythmia therapy problems ................... 433
13.7 Solving bradycardia pacing problems ................................. 434
13.8 Responding to device status indicators ............................... 435
Appendices
A Warnings and precautions ........................................ 438
A.1 General .......................................................... 438
A.2 Handling and storage instructions .................................... 438
A.3 Lead evaluation and lead connection ................................. 440
A.4 Device operation ................................................... 440
A.5 Warnings, precautions, and guidance for clinicians performing medical
procedures on cardiac device patients .............................. 441
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A.6 Warnings, precautions, and guidance related to electromagnetic
interference (EMI) for cardiac device patients ........................ 447
B Device Parameters ............................................... 451
B.1 Emergency settings ................................................ 451
B.2 Tachyarrhythmia detection parameters ................................ 452
B.3 Atrial tachyarrhythmia therapy parameters, AT devices .................. 455
B.4 Ventricular tachyarrhythmia therapy parameters ........................ 457
B.5 Bradycardia pacing parameters ...................................... 460
B.6 Patient Alert parameters ............................................ 465
B.7 Data collection parameters .......................................... 467
B.8 System test parameters ............................................. 468
B.9 EP study parameters ............................................... 470
B.10 Nonprogrammable parameters ...................................... 474
Glossary ................................................................ 479
Index ................................................................... 490
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Introduction
About this manual
This manual describes the operation and intended use of the EnTrust Model D154ATG,
D154DRG, and D154VRC systems.
EnTrust Model D154ATG devices, referred to as “AT” devices in this manual, provide atrial
and 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 AT devices.
EnTrust Model D154DRG devices, referred to as “DR” devices in this manual, provide atrial
tachyarrhythmia monitoring, dual chamber tachyarrhythmia detection, ventricular
tachyarrhythmia therapy, and a full range of dual chamber bradycardia pacing modes and
associated features. Information in this manual that describes atrial tachyarrhythmia
detection features (other than atrial monitoring) and atrial tachyarrhythmia therapy features
does not apply to DR devices.
EnTrust Model D154VRC devices, referred to as “VR” devices in this manual, provide
ventricular tachyarrhythmia detection, ventricular tachyarrhythmia therapy, and single
chamber bradycardia pacing. Information in this manual that describes atrial
tachyarrhythmia detection, atrial tachyarrhythmia therapy, dual chamber detection, dual
chamber pacing features, and atrial pacing modes does not apply to VR devices.
Programmer hardware and screen images
The screen image examples in this manual show the Medtronic CareLink Model 2090
programmer screen. Wherever possible, these screen images show the application for an
AT device (EnTrust Model D154ATG).
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 9790/9790C Programmer Instruction Manual.
Manual conventions
Throughout this document, the word “device” refers to the implanted EnTrust device.
The symbol in parameter tables indicates the Medtronic nominal value for that parameter.
On-screen buttons are shown with the name of the button surrounded by brackets: [Button
Name].
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Additional literature
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.
Technical support
Medtronic employs highly trained representatives and engineers located throughout the
world to serve 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 more information, contact your local Medtronic representative, or call or write Medtronic
at the appropriate telephone number or address 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, ed. Cardiac Pacing Diagnostic and Therapeutic
Tools. New York: Springer-Verlag; 1976: 212-218.
See these additional references for more background information:
●
Estes M, Manolis AS, Wang P, Eds. Implantable Cardioverter-Defibrillators. New York,
NY: Marcel Dekker, Inc. 1994.
●
Kroll MW, Lehmann MH, Eds. Implantable Cardioverter-Defibrillator Therapy: The
Engineering-Clinical Interface. Norwell, MA: Kluwer Academic Publishers 1996.
●
Singer I, Ed. Implantable Cardioverter-Defibrillator. Armonk, NY: Futura Publishing Co.
1994.
●
Singer I, Barold SS, Camm AJ, Eds. Nonpharmacological Therapy of Arrhythmias for
the 21st Century: The State of the Art. Armonk, NY: Futura Publishing Co. 1998.
●
Stadler RW, Gunderson BD, Gillberg JM. An Adaptive Interval-Based Algorithm for
Withholding ICD Therapy During Sinus Tachycardia. Pace. 2003; 26:1189–1201.
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Notice
The Patient Information screen of the programmer software application 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 patient information that end users enter into the Patient Information
screen. Medtronic SHALL NOT BE LIABLE FOR ANY DIRECT, INDIRECT, INCIDENTAL,
OR CONSEQUENTIAL DAMAGES TO ANY THIRD PARTY WHICH RESULT FROM THE
USE OF THE PATIENT INFORMATION SUPPLIED BY END USERS TO THE SOFTWARE.
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Part I
Quick overview
1 Quick reference
1.1 Physical characteristics, AT and DR devices
Table 1. Device physical characteristics
Volume
Mass 68 g
H x W x D
Surface area of device can 60 cm
Radiopaque ID PNR
Materials in contact with human tissuecTitanium, polyurethane, silicone rubber
Battery Lithium silver vanadium oxide hybrid
a
b
c
a
b
Volume with connector holes unplugged.
Grommets may protrude slightly beyond the can surface.
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 during normal operation.
3
35 cm
62 mm x 51 mm x 15 mm
2
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1
2
3
4
5
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Figure 1. Connector and suture holes
D154ATG, D154DRG, D154VRC
1 IS-1 connector port, V
2 IS-1 connector port, A
3 DF-1 connector port, SVC (HVX)
4 DF-1 connector port, RV (HVB)
5 Device Active Can electrode, Can (HVA)
6 Suture holes
1.2 Physical characteristics, VR devices
Table 2. Device physical characteristics
Volume
Mass 68 g
H x W x D
Surface area of device can 60 cm
a
b
Radiopaque ID PNT
Materials in contact with human tissuecTitanium, polyurethane, silicone rubber
Battery Lithium silver vanadium oxide hybrid
a
Volume with connector holes unplugged.
b
Grommets may protrude slightly beyond the can surface.
c
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 during normal operation.
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3
35 cm
63 mm x 51 mm x 15 mm
2
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Figure 2. Connector and suture holes
D154ATG, D154DRG, D154VRC
1 IS-1 connector port, V
2 DF-1 connector port, SVC (HVX)
3 DF-1 connector port, RV (HVB)
4 Device Active Can electrode, Can (HVA)
5 Suture holes
1.3 Replacement indicators
Battery voltage and messages about replacement status appear on the programmer display
and on printed reports. Table 3 lists the Elective Replacement Indicator (ERI) and the End
of Life (EOL) conditions.
Table 3. Replacement indicators
Elective Replacement Indicator (ERI) ≤ 2.61 V on three consecutive daily automatic
measurements
End of Life (EOL) 3 months after ERI
ERI date – The Quick Look and Battery and Lead Measurements screens display the date
when the battery reached ERI.
EOL indication – If the programmer indicates that the device is at EOL, replace the device
immediately.
Post-ERI conditions – EOL device status is defined as three months following an ERI
indication assuming the following post-ERI conditions: 100% DDD pacing (VVI in VR
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devices) at 60 bpm, 2.5 V, 0.4 ms; 500 Ω pacing load; and six full-energy charges. EOL
may be indicated before the end of three months if the device exceeds these conditions.
1.4 Longevity projections
Device longevity is affected by how certain features are programmed, such as
Pre-arrhythmia EGM. See Section 4.12, “Optimizing device longevity”, page 55.
1.4.1 AT and DR device longevity projections
The following longevity estimates are based on accelerated battery discharge data and
device modeling, as specified.
These models assume the default automatic capacitor formation setting. As a guideline,
each full energy charge decreases device longevity by approximately 34 days.
Table 4. Projected longevity in years with 0.4 ms pulse width and 60 bpm pacing rate
Maximum energy
charging fre-
Pacing
DDD, 0% Semi-annual Off 8.3 8.3 8.3 8.3
DDD, 15% Semi-annual Off 8.0 7.9 8.2 8.1
DDD, 50% Semi-annual Off 7.4 7.1 7.8 7.6
AAI<=>DDD,
(MVP mode)
50% atrial,
5% ventricular
quency
Quarterly Off 7.1 7.1 7.1 7.1
Quarterly Off 6.9 6.8 7.0 6.9
Quarterly Off 6.4 6.2 6.7 6.6
Semi-annual Off 7.9 7.7 8.2 8.1
Quarterly Off 6.8 6.7 7.0 6.9
a
Pre-arrhythmia
EGM storage
On 8.1 8.1 8.1 8.1
On 6.9 6.9 6.9 6.9
On 7.8 7.7 8.0 7.9
On 6.7 6.6 6.8 6.8
On 7.2 6.9 7.6 7.4
On 6.2 6.0 6.6 6.4
On 7.7 7.5 8.0 7.9
On 6.6 6.5 6.8 6.7
500 Ω pacing
impedance
b
2.5 V 3.0 V 2.5 V 3.0 V
900 Ω pacing
impedance
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Table 4. Projected longevity in years with 0.4 ms pulse width and 60 bpm pacing rate
(continued)
500 Ω pacing
impedance
b
2.5 V 3.0 V 2.5 V 3.0 V
Pacing
Maximum energy
charging frequency
a
Pre-arrhythmia
EGM storage
DDD, 100% Semi-annual Off 6.6 6.1 7.4 7.0
On 6.5 6.0 7.2 6.8
Quarterly Off 5.8 5.4 6.4 6.1
On 5.7 5.3 6.2 5.9
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 3.3 months per year.
900 Ω pacing
impedance
1.4.2 VR device longevity projections
The following longevity estimates are based on accelerated battery discharge data and
device modeling, as specified.
These models assume the default automatic capacitor formation setting. As a guideline,
each full energy charge decreases device longevity by approximately 49 days.
Table 5. Projected longevity in years with VVI pacing mode, 0.4 ms pulse width, and 60 bpm pacing rate
500 Ω pacing
impedance
b
2.5 V 3.0 V 2.5 V 3.0 V
% Pacing
Maximum energy
charging frequency
a
Pre-arrhythmia
EGM storage
0% Semi-annual Off 11.1 11.1 11.1 11.1
On 10.9 10.9 10.9 10.9
Quarterly Off 9.1 9.1 9.1 9.1
On 8.8 8.8 8.8 8.8
15% Semi-annual Off 10.9 10.7 11.0 10.9
On 10.6 10.5 10.7 10.6
Quarterly Off 8.9 8.8 9.0 8.9
On 8.7 8.6 8.7 8.7
50% Semi-annual Off 10.3 9.9 10.7 10.5
On 10.0 9.7 10.4 10.2
Quarterly Off 8.5 8.3 8.7 8.6
On 8.3 8.0 8.5 8.4
900 Ω pacing
impedance
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Table 5. Projected longevity in years with VVI pacing mode, 0.4 ms pulse width, and 60 bpm
pacing rate (continued)
500 Ω pacing
impedance
b
2.5 V 3.0 V 2.5 V 3.0 V
% Pacing
Maximum energy
charging frequency
a
Pre-arrhythmia
EGM storage
100% Semi-annual Off 9.5 9.0 10.2 9.9
On 9.3 8.8 10.0 9.6
Quarterly Off 8.0 7.6 8.4 8.2
On 7.8 7.4 8.2 8.0
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
33% or 4.0 months per year.
900 Ω pacing
impedance
1.5 Magnet application
When a magnet is placed near the device, the device responds as shown in Table 6. When
the magnet is removed, the device returns to its programmed operations.
Note: Before implant and for the first 6 hours after implant, the device will not sound audible
tones when a magnet is placed over the device.
Table 6. Effects of magnet application on the device
Pacing mode As programmed
Pacing rate and interval As programmed
Tachyarrhythmia detection Suspended
Patient Alert audible tones (20 s or
less)
With programmable alerts enabled:
●
Continuous tone (Test)
●
On/off intermittent tone (seek follow-up)
●
High/low dual tone (urgent follow-up)
a
b
c
With programmable alerts disabled:
●
No tone
●
High/low dual tone (urgent follow-up)
a
Rate Response adjustments are suspended while a Patient Alert tone sounds.
b
Detection resumes if telemetry between the device and the programmer is established and the application
software is running.
c
The Test tone does not sound if “VF Detection OFF, 3+ VF or 3+ FVT Rx Off” is the only alert enabled.
1.6 Typical charge times
The most recent capacitor charge time appears on the programmer display and on printed
reports. You can evaluate charge time using the Charge/Dump test (see Table 7).
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Table 7. Typical full energy charge times with fully formed capacitors
At Beginning of Life (BOL) 8.0 s
At Elective Replacement (ERI) 11.0 s (AT and DR devices)
11.8 s (VR devices)
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 8 compares the programmed energy
levels delivered by the device to the energy levels stored in the capacitors before delivery.
Table 8. Delivered (programmed) and stored energy levels
Delivered/Programmed
35 J 39 J 8.0 s
32 J 36 J 7.3 s
30 J 34 J 6.9 s
28 J 32 J 6.4 s
26 J 29 J 5.9 s
25 J 28 J 5.7 s
24 J 27 J 5.5 s
22 J 25 J 5.0 s
20 J 23 J 4.6 s
18 J 20 J 4.1 s
16 J 18 J 3.7 s
15 J 17 J 3.4 s
14 J 16 J 3.2 s
13 J 15 J 3.0 s
12 J 14 J 2.7 s
11 J 13 J 2.5 s
10 J 11 J 2.3 s
9 J 10 J 2.1 s
8 J 9.1 J 1.8 s
7 J 8.0 J 1.6 s
6 J 6.9 J 1.4 s
5 J 5.7 J 1.1 s
4 J 4.6 J 0.9 s
3 J 3.5 J 0.7 s
2 J 2.3 J 0.5 s
1.8 J 2.1 J 0.4 s
a
Stored
a
a
Charge Time
b
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Table 8. Delivered (programmed) and stored energy levelsa (continued)
Delivered/Programmed
a
1.6 J 1.9 J 0.4 s
1.4 J 1.7 J 0.3 s
1.2 J 1.5 J 0.3 s
1.0 J 1.2 J 0.2 s
0.8 J 0.9 J 0.2 s
0.6 J 0.7 J 0.1 s
0.4 J 0.5 J 0.1 s
a
Delivered energy values are based on measurements at the connector block during high-voltage therapies into
a 75 Ω load. Stored energy values indicate the energy on the capacitor at the end of charging.
b
Typical charge time at Beginning of Life (BOL) with fully formed capacitors, rounded to the nearest tenth of a
second.
Stored
a
Charge Time
b
1.8 Stored data and diagnostics
Table 9. Arrhythmia episode data storage
Episode data type AT devices DR devices VR devices
Treated VT/VF episode log entries 100 entries 100 entries 100 entries
Treated VT/VF episode EGM, mark-
ers, and intervals
Monitored VT episode log entries 15 entries 15 entries 15 entries
Monitored VT episode EGM, mark-
ers, and intervals
Non-sustained VT episode log entries 15 entries 15 entries 15 entries
Non-sustained VT episode EGM,
markers, and intervals
Treated AT/AF episode log entries 100 entries — —
Treated AT/AF episode EGM, mark-
ers, and intervals
Monitored AT/AF episode log entries 50 entries 50 entries —
Monitored AT/AF episode EGM,
markers, and intervals
SVT episode log entries 25 entries 25 entries 25 entries
SVT episode EGM, markers, and
intervals
Patient activated episode log entries 50 entries 50 entries 50 entries
9.25 min 12.5 min 13.75 min
45 s 45 s 51 s
30 s 30 s 30 s
3.75 min — —
1.0 min 1.5 min —
1.25 min 1.25 min 1.4 min
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Table 9. Arrhythmia episode data storage (continued)
Episode data type AT devices DR devices VR devices
Flashback memory interval data
before each of the following events:
●
Interrogation
●
Latest VF episode
●
Latest VT episode
Flashback memory interval data
before the latest AT/AF episode
2000 events
(includes both Aand V-events)
2000 events
(includes both Aand V-events)
2000 events
(includes both Aand V-events)
2000 events
(includes both Aand V-events)
2000 events
(V-events only)
—
Table 10. VT/VF episode counters
Counter data type AT and DR devices VR devices
Counts of each VT/VF episode type
Counts of each SVT episode type
(VT/VF therapy withheld)
●
VF
●
FVT
●
VT
●
VT Monitor
●
VT-NS
●
Runs of PVCs
●
Single PVCs
●
Runs of VRS paces
●
Single VRS paces
●
AF/Afl
●
Sinus Tach
●
Other 1:1 SVTs
●
V. Stability
●
Onset
●
VF
●
FVT
●
VT
●
VT Monitor
●
VT-NS
●
Runs of PVCs
●
Single PVCs
●
Runs of VRS paces
●
Single VRS paces
●
V. Stability
●
Onset
●
Wavelet
Table 11. VT/VF therapy counters
Counter data type AT, DR and VR devices
VT/VF therapy summary counters
VT/VF therapy efficacy counters
●
ATP-terminated episodes
●
Shock-terminated episodes
●
Total VT/VF shocks
●
Aborted charges
For VF Rx1–Rx6 and ATP during/before charging:
●
Delivered therapy counts
●
Successful therapy counts
For FVT Rx1–Rx6:
●
Delivered therapy counts
●
Successful therapy counts
●
Counts of episodes accelerated to VF
For VT Rx1–Rx6:
●
Delivered therapy counts
●
Successful therapy counts
●
Counts of episodes accelerated by 60 ms or to FVT or VF
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Table 12. AT/AF episode counters
Counter data type AT devices DR devices
AT/AF summary data
●
Percent of time in AT/AF
●
Average time in AT/AF per
day
●
Percentage of AT/AF epi-
●
Percent of time in AT/AF
●
Average time in AT/AF
per day
sodes terminated by ATP
Average number per day of each
AT/AF episode type
Percent of time in each kind of pacing
Number of AT/AF episodes, presented in different groupings
a
This counter includes any instance when the device identifies AT/AF Onset. Therefore, the total number of
●
Monitored AT/AF
●
Treated AT/AF
●
Non-sustained AT
●
Atrial pacing
●
Atrial intervention pacing
●
Grouped by duration
●
Grouped by start time
a
episodes in this counter may exceed the number of detected AT/AF episodes recorded by the device.
●
Monitored AT/AF
●
Non-sustained AT
●
Atrial pacing
●
a
Grouped by duration
●
Grouped by start time
Table 13. AT/AF therapy counters
Counter data type AT devices
Number of AT/AF episodes treated
and the percentage terminated,
presented in different groupings
Counts of different AT/AF therapy
types
●
Grouped by detection zone and therapy
●
Grouped by atrial cycle length
●
Delivered ATP sequences
●
Aborted ATP sequences
●
Delivered automatic atrial CV shocks
●
Automatic atrial CV shocks that failed to terminate the
episode
●
Delivered patient-activated shocks
●
Patient-activated shocks that failed to terminate the episode
a
a
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Table 14. Battery and lead measurement data
AT devices DR devices VR devices
●
Battery voltage
●
Last capacitor formation
●
Last charge
●
Lead impedance:
– A. pacing
– RV pacing
– RV defib
– SVC defib (if used)
●
R-wave amplitude
●
P-wave amplitude
●
Last high-voltage therapy
●
Sensing integrity counter
●
Atrial Lead Position Check
●
Battery voltage
●
Last capacitor formation
●
Last charge
●
Lead impedance:
– A. pacing
– RV pacing
– RV defib
– SVC defib (if used)
●
R-wave amplitude
●
P-wave amplitude
●
Last high-voltage therapy
●
Sensing integrity counter
●
Battery voltage
●
Last capacitor formation
●
Last charge
●
Lead impedance:
– RV pacing
– RV defib
– SVC defib (if used)
●
R-wave amplitude
●
Last high-voltage therapy
●
Sensing integrity counter
results
Table 15. Lead performance trend data
14 days of daily measurements, 80 weeks of weekly minimum and maximum measurements, highest value, lowest value, value at implant, and latest value.
AT and DR devices VR devices
Lead impedance measurements:
●
A. Pacing
●
RV pacing
●
RV defibrillation
●
SVC defibrillation (if used)
Sensing amplitude measurements:
●
P-wave
●
R-wave
Lead impedance measurements:
●
RV pacing
●
RV defibrillation
●
SVC defibrillation (if used)
Sensing amplitude measurements:
●
R-wave
Table 16. Cardiac Compass trend data
Printed report showing up to 14 months of measurement trends and summary data.
AT and DR devices VR devices
●
Annotations of interrogations, programming,
and remote sessions
●
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
●
Annotations of interrogations, programming,
and remote sessions
●
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
●
Percent pacing per day
●
Patient activity
●
Average day and night ventricular heart rate
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Table 17. Rate Histograms report
Data type AT devices DR devices VR devices
Graphs displaying the
percent of time in each
rate range for the listed
conditions:
●
Atrial pacing and
atrial sensing
●
Ventricular pacing
and ventricular
sensing
●
Ventricular pacing
a
●
Atrial pacing and
atrial sensing
●
Ventricular pacing
and ventricular
sensing
●
a
Ventricular pacing
and ventricular
sensing
and ventricular
sensing during
AT/AF
Percent of time for
each event type:
a
If more than 2% of atrial sensed events are identified as far-field R-waves, the general percentage range (either
“2% to 5%” or “> 5%”) is reported above the atrial rate histogram.
b
In AT and DR devices, if the programmed pacing mode during the reporting period was a dual chamber mode,
b
●
AS-VS events
●
AS-VP events
●
AP-VS events
●
AP-VP events
the report displays the AS-VS, AS-VP, AP-VS, and AP-VP event sequence data. If a single chamber mode was
programmed, the report displays the percent of time spent pacing and sensing. MVP modes (AAIR<=>DDDR
and AAI<=>DDD) are considered dual chamber modes for this purpose.
●
AS-VS events
●
AS-VP events
●
AP-VS events
●
AP-VP events
●
VP events
●
VS events
Table 18. Patient Alert event data
Log of events that triggered Patient Alert notifications. Each log entry includes the following information:
●
Date when the event first occurred (since the last interrogation)
●
Description of event that triggered the Patient Alert
●
Programmed threshold for the Patient Alert, if applicable
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2 The EnTrust system
2.1 System overview
EnTrust Implantable Cardioverter Defibrillator (ICD) systems are implantable medical
devices that automatically detect and treat episodes of ventricular fibrillation (VF),
ventricular tachycardia (VT), fast ventricular tachycardia (FVT), and bradyarrhythmia. The
EnTrust AT device also detects and treats atrial tachyarrhythmia episodes.
Each EnTrust ICD system includes three major components: the implanted device, the
leads connecting the device to the patient’s heart, and the Medtronic programmer with
EnTrust application software installed.
2.1.1 Implanted device
The device senses the electrical activity of the patient’s heart using the sensing electrodes
of the implanted leads. It analyzes the heart rhythm based on selectable sensing and
detection parameters. If the device detects a ventricular tachyarrhythmia, it can deliver
defibrillation, cardioversion, or antitachycardia pacing therapy to the patient’s heart. If the
device identifies a bradyarrhythmia, it delivers bradycardia pacing therapy.
2.1.2 Leads
The device can be used with transvenous or epicardial defibrillation leads. The lead system
should consist of bipolar or paired unipolar1 leads for pacing and sensing and one or two
high-voltage cardioversion/defibrillation electrodes. The pacing and sensing electrodes
sense cardiac activity and deliver pacing stimuli. AT and DR devices require both atrial and
ventricular leads to be implanted. VR devices require only ventricular leads. The device
case may optionally be used as an Active Can high voltage electrode. You can enable or
disable this option using the programmable Active Can parameter.
2.1.3 Programmer and software
The Medtronic programmer and EnTrust application software 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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The EnTrust device and application software are compatible with the Medtronic CareLink
Model 2090 programmer with a Model 2067 or 2067L programming head.
2.1.4 Patient assistant
Patients with implanted AT devices can use the Model 2696 InCheck Patient Assistant to
perform the following functions:
●
Verify whether the implanted device has detected a suspected atrial tachyarrhythmia.
●
Initiate recording of cardiac event data in the device memory.
●
Request delivery of atrial cardioversion therapy (if the device is programmed to allow
patient-activated cardioversion).
Note: Patient-activated cardioversion is only delivered if the implanted device is
currently detecting an AT/AF episode.
2.1.5 Detecting ventricular tachyarrhythmias
The device monitors the cardiac rhythm for short ventricular intervals that may indicate the
presence of VF, VT, or FVT.
You can program the device to distinguish between true ventricular arrhythmias and rapidly
conducted supraventricular tachycardia (SVT) and to withhold therapy for SVT.
AT and DR devices also have the ability to detect double tachycardias (unrelated ventricular
arrhythmias occurring simultaneously with SVTs) so that therapy is not withheld for a
ventricular arrhythmia in the presence of an SVT.
2.1.6 Treating ventricular tachyarrhythmias
The device treats detected VF episodes by delivering a biphasic defibrillation shock. If the
VF episode persists, up to 5 more individually programmed defibrillation shocks can be
delivered.
You also have the option of delivering 1 sequence of ATP therapy before or during charging
for a VF therapy. This option can prevent delivery of painful shocks for episodes that are
detected as VF but can be terminated by pacing therapy.
The device treats detected VT episodes by delivering either a Ramp, Ramp+, or Burst
antitachycardia pacing therapy or a biphasic cardioversion shock synchronized to a
ventricular depolarization. If the VT episode persists, up to 5 more individually programmed
VT therapies can be delivered.
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The device treats detected FVT episodes by delivering either a Ramp, Ramp+, or Burst
antitachycardia pacing therapy or a biphasic cardioversion shock synchronized to a
ventricular depolarization. If the FVT episode persists, up to 5 more individually
programmed FVT therapies can be delivered.
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2.1.7 Detecting atrial tachyarrhythmias
If there is no ventricular episode in progress, the device applies the AT/AF detection
algorithm, which detects AT/AF episodes by examining the atrial rate and the relationship
between atrial and ventricular events. Both AT and DR devices can detect AT/AF episodes,
but only AT devices can respond to detected AT/AF episodes with programmed atrial
tachyarrhythmia therapies. AT devices also provide an additional detection zone for Fast
AT/AF episodes. This second zone allows the device to treat a second, faster atrial
tachyarrhythmia with a separately programmable set of therapies.
2.1.8 Treating atrial tachyarrhythmias
The device treats detected AT/AF episodes by delivering Burst+, Ramp or 50 Hz Burst
antitachycardia pacing therapy or by delivering an atrial cardioversion. Each sustained
AT/AF episode can be treated with up to 5 automatic therapies per detection zone: 3
antitachycardia pacing therapies and 2 atrial cardioversion therapies. Patient-activated
cardioversion is also available to treat AT/AF episodes.
2.1.9 Treating bradycardia
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.
VR devices provide single chamber ventricular pacing modes. AT and DR devices provide
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 and manage unnecessary right ventricular pacing.
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2.1.10 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,
shocks delivered, physical activity, heart rate, and bradycardia pacing activities. The Rate
Histograms report shows the percent of time that cardiac events occurred at different heart
rates. In AT and DR devices, this report also shows the distribution of ventricular heart rates
during AT/AF episodes.
All of this information can be printed and retained in the patient’s file or saved in electronic
format on a floppy diskette.
2.1.11 Conducting electrophysiologic tests
You can use the system to conduct non-invasive electrophysiologic studies, including
manual delivery of therapies, to manage an induced or spontaneous tachyarrhythmia.
2.1.12 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 occur that are related to the leads, battery, charge time,
or therapies. The patient can then respond based on your prescribed instructions.
2.2 Indications and usage, AT devices
The device is indicated for use in ICD patients with atrial tachyarrhythmias, or who are at
significant risk of developing atrial tachyarrhythmias. The device is intended to provide
ventricular antitachycardia pacing and ventricular defibrillation for automated treatment of
life-threatening ventricular arrhythmias.
In addition, the device is intended to provide pacing, cardioversion, and defibrillation for
treatment of patients with
●
symptomatic, drug-refractory atrial fibrillation and/or
●
life-threatening ventricular tachyarrhythmias.
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Notes:
●
The use of the device has not been demonstrated to decrease the morbidity related to
atrial tachyarrhythmias.
●
The effectiveness of high-frequency burst pacing (atrial 50 Hz Burst therapy) in
terminating device classified atrial tachycardia (AT) was found to be 17%, and in
terminating device classified atrial fibrillation (AF) was found to be 16.8%, in the VT/AT
patient population studied.
●
The effectiveness of high-frequency burst pacing (atrial 50 Hz Burst therapy) in
terminating device classified atrial tachycardia (AT) was found to be 11.7%, and in
terminating device classified atrial fibrillation (AF) was found to be 18.2%, in the AF-only
patient population studied.
2.3 Indications and usage, DR and VR devices
The implantable cardioverter defibrillator is intended to provide ventricular antitachycardia
pacing and ventricular defibrillation for automated treatment of life-threatening ventricular
arrhythmias.
2.4 Contraindications, AT devices
The device is contraindicated for patients experiencing any of the following conditions:
●
tachyarrhythmias with transient or reversible causes including, but not limited to, the
following: acute myocardial infarction, digitalis intoxication, drowning, electric shock,
electrolyte imbalance, hypoxia, or sepsis
●
incessant ventricular tachycardia or ventricular fibrillation
●
primary disorder of chronic atrial tachyarrhythmia with no concomitant VT or VF
●
present implant of a unipolar implantable pulse generator
●
primary disorder of bradyarrhythmia
2.5 Contraindications, DR and VR devices
The device is contraindicated for patients experiencing any of the following conditions:
●
tachyarrhythmias with transient or reversible causes including, but not limited to, the
following: acute myocardial infarction, digitalis intoxication, drowning, electric shock,
electrolyte imbalance, hypoxia, or sepsis
●
incessant ventricular tachycardia or ventricular fibrillation
●
present implant of a unipolar implantable pulse generator
●
primary disorder of bradyarrhythmia or atrial arrhythmia
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