Medtronic D154AWG Reference Guide
VIRTUOSO® DR/VR D154AWG/
D154VWC
Implantable cardioverter defibrillator systems with OptiVol
Fluid Monitoring, and Conexus® Telemetry
®
Reference Manual
Caution: Federal law (USA) restricts this device to sale by or on the order of a physician.
VIRTUOSO® DR/VR D154AWG/
D154VWC
Reference Manual
A guide to the operation and programming of the Virtuoso 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, CareAlert, CareLink,
ChargeSaver, Checklist, Conexus, Flashback, InCheck, Intrinsic, MVP,
Marker Channel, Medtronic, Medtronic CareAlert, Medtronic CareLink, OptiVol,
PR Logic, Paceart, Quick Look, QuickLink, Reactive ATP, SessionSync,
Switchback, T-Shock, Virtuoso
Medtronic VIRTUOSO
®
DR/VR D154AWG/D154VWC
Contents
Introduction .............................................................. 11
Part I Quick overview ......................................... 14
1 Quick reference ................................................... 14
1.1 Physical characteristics, DR devices ................................... 14
1.2 Physical characteristics, VR devices ................................... 15
1.3 Replacement indicators .............................................. 16
1.4 Projected service life ................................................ 17
1.5 Magnet application .................................................. 19
1.6 Typical charge times ................................................ 19
1.7 High-voltage therapy energy .......................................... 19
1.8 Stored data and diagnostics .......................................... 20
2 The Virtuoso system ............................................... 25
2.1 System overview .................................................... 25
2.2 Indications and usage, DR devices .................................... 29
2.3 Indications and usage, VR devices .................................... 30
2.4 Contraindications, DR devices ........................................ 30
2.5 Contraindications, 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 .......................... 32
3.3 Delivering an emergency cardioversion therapy ......................... 33
3.4 Delivering emergency fixed burst pacing ............................... 34
3.5 Enabling emergency VVI pacing ...................................... 35
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Part II Device implant and patient follow-up
procedures ...................................................... 37
4 Implanting the device .............................................. 37
4.1 Overview .......................................................... 37
4.2 Considerations ..................................................... 37
4.3 Preparing for an implant ............................................. 38
4.4 Verifying lead and connector compatibility .............................. 40
4.5 Positioning the leads ................................................ 40
4.6 Testing the lead system .............................................. 42
4.7 Connecting the leads to the device .................................... 43
4.8 Testing ventricular defibrillation operation and effectiveness .............. 46
4.9 Positioning and securing 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 .................... 60
5.5 Verifying effective bradycardia pacing ................................. 61
Part III Configuring the device for the patient .......... 63
6 Detecting tachyarrhythmias ........................................ 63
6.1 Detection overview .................................................. 63
6.2 Setting up sensing .................................................. 68
6.3 Detecting atrial tachyarrhythmias ...................................... 72
6.4 Detecting VF episodes ............................................... 76
6.5 Detecting VT episodes ............................................... 79
6.6 Detecting FVT episodes ............................................. 83
6.7 Monitoring VT episodes .............................................. 86
6.8 Detecting tachyarrhythmia episodes with combined count ................ 90
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6.9 Determining episode termination or redetection ......................... 92
6.10 Enhancing detection with PR Logic criteria ............................. 95
6.11 Enhancing detection with Wavelet .................................... 100
6.12 Enhancing VT detection with the Onset criterion ........................ 109
6.13 Enhancing VT detection with the Stability criterion ...................... 113
6.14 Detecting double tachycardias ....................................... 115
6.15 Detecting prolonged tachyarrhythmias with High Rate Timeout ........... 115
7 Treating tachyarrhythmia episodes ................................ 118
7.1 Controlling atrial therapy sequencing ................................. 118
7.2 Treating atrial arrhythmias with cardioversion .......................... 127
7.3 Providing patient-activated atrial cardioversion ......................... 133
7.4 Treating atrial arrhythmias with antitachycardia pacing .................. 136
7.5 Treating episodes detected as VF .................................... 145
7.6 Treating VT and FVT with antitachycardia pacing ....................... 157
7.7 Treating VT and FVT with ventricular cardioversion ..................... 164
7.8 Optimizing ventricular ATP therapy with Smart Mode .................... 170
7.9 Optimizing therapy with Progressive Episode Therapies ................. 172
8 Treating bradycardia ............................................. 174
8.1 Providing basic pacing therapy ...................................... 174
8.2 Dual chamber pacing ............................................... 177
8.3 Single chamber pacing ............................................. 187
8.4 MVP (Managed Ventricular Pacing) .................................. 191
8.5 Rate Response .................................................... 195
8.6 Rate Adaptive AV .................................................. 200
8.7 Rate Hysteresis .................................................... 202
8.8 Mode Switch ...................................................... 204
8.9 Non-Competitive Atrial Pacing ....................................... 206
8.10 PMT Intervention .................................................. 209
8.11 PVC Response .................................................... 211
8.12 Ventricular Safety Pacing ........................................... 213
8.13 Atrial Rate Stabilization ............................................. 215
8.14 Atrial Preference Pacing ............................................ 218
8.15 Post Mode Switch Overdrive Pacing (PMOP) .......................... 222
8.16 Ventricular Rate Stabilization (VRS) .................................. 223
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8.17 Post VT/VF Shock Pacing ........................................... 225
8.18 Post Shock Pacing ................................................. 226
®
DR/VR D154AWG/D154VWC
Part IV Evaluating and managing patient treatment .. 228
9 Using the programmer ............................................ 228
9.1 Setting programmer preferences ..................................... 228
9.2 Establishing telemetry between the device and programmer ............. 228
9.3 Starting a patient session ........................................... 236
9.4 Ending a patient session ............................................ 238
9.5 Device and telemetry effects during a patient session ................... 239
9.6 Display screen features ............................................. 240
9.7 Streamlining follow-up and implant sessions with Checklist .............. 245
9.8 Viewing and programming device parameters .......................... 251
9.9 Saving and retrieving a set of parameter values ........................ 256
9.10 Viewing live waveform traces ........................................ 258
9.11 Recording live waveform strips ....................................... 267
9.12 Freezing and analyzing a waveform strip .............................. 269
9.13 Recalling and viewing waveform strips ................................ 270
9.14 Transferring, saving, and retrieving device data ........................ 271
9.15 Printing reports .................................................... 278
10 Setting up and viewing collected data .............................. 284
10.1 A summary of data collection ........................................ 284
10.2 Setting up data collection ........................................... 285
10.3 Viewing Quick Look data ............................................ 291
10.4 Using the Medtronic CareAlert feature ................................ 295
10.5 Viewing Arrhythmia Episode data .................................... 306
10.6 Viewing Flashback Memory data ..................................... 318
10.7 Using Cardiac Compass to view long-term clinical trends ................ 320
10.8 Using Rate Histograms reports ...................................... 329
10.9 Viewing the counters ............................................... 332
10.10 Viewing Battery and Lead Measurement data .......................... 339
10.11 Viewing Lead Performance Trends data ............................... 342
10.12 Viewing and entering patient information .............................. 345
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10.13 Automatic device status monitoring ................................... 347
11 Testing the system ............................................... 350
11.1 System test overview ............................................... 350
11.2 Evaluating the underlying rhythm ..................................... 351
11.3 Measuring pacing thresholds ........................................ 351
11.4 Testing the Wavelet criterion ........................................ 354
11.5 Measuring lead impedance .......................................... 358
11.6 Performing a Sensing Test .......................................... 360
11.7 Testing the device capacitors ........................................ 362
12 Conducting electrophysiologic studies ............................ 365
12.1 EP Study overview ................................................. 365
12.2 Inducing VF with T-Shock ........................................... 366
12.3 Inducing VF with 50 Hz Burst ........................................ 369
12.4 Delivering an atrial 50 Hz Burst ...................................... 372
12.5 Inducing an arrhythmia with Fixed Burst ............................... 375
12.6 Inducing an arrhythmia with PES ..................................... 378
12.7 Delivering a manual therapy ......................................... 381
13 Solving system problems ......................................... 386
13.1 Overview ......................................................... 386
13.2 Solving sensing problems ........................................... 386
13.3 Solving atrial tachyarrhythmia detection problems ...................... 388
13.4 Solving ventricular tachyarrhythmia detection problems ................. 389
13.5 Solving atrial tachyarrhythmia therapy problems ........................ 390
13.6 Solving ventricular tachyarrhythmia therapy problems ................... 394
13.7 Solving bradycardia pacing problems ................................. 395
13.8 Solving OptiVol fluid monitoring problems ............................. 396
13.9 Responding to device status indicators ............................... 397
Appendices
A Warnings and precautions ........................................ 399
A.1 General .......................................................... 399
A.2 Handling and storage instructions .................................... 399
A.3 Lead evaluation and lead connection ................................. 400
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A.4 Device operation ................................................... 401
A.5 Warnings, precautions, and guidance for clinicians performing medical
procedures on cardiac device patients .............................. 402
A.6 Warnings, precautions, and guidance related to electromagnetic
interference (EMI) for cardiac device patients ........................ 408
B Device Parameters ............................................... 412
B.1 Emergency settings ................................................ 412
B.2 Tachyarrhythmia detection parameters ................................ 412
B.3 Atrial tachyarrhythmia therapy parameters, DR devices ................. 415
B.4 Ventricular tachyarrhythmia therapy parameters ........................ 417
B.5 Bradycardia pacing parameters ...................................... 419
B.6 Medtronic CareAlert parameters ..................................... 423
B.7 Data collection parameters .......................................... 427
B.8 System test parameters ............................................. 429
B.9 EP study parameters ............................................... 430
B.10 Nonprogrammable parameters ...................................... 434
Glossary ................................................................ 437
Index ................................................................... 449
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Introduction
About this manual
This manual describes the operation and intended use of the Virtuoso Model D154AWG
and D154VWC systems.
Virtuoso Model D154AWG devices, referred to as “DR” 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 DR devices.
Virtuoso Model D154VWC 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 were taken from the Medtronic CareLink Model
2090 programmer with Conexus Telemetry. Wherever possible, these screen images show
the application for a DR device (Virtuoso Model D154AWG).
The information provided in this manual about using the programmer assumes the
Medtronic CareLink Model 2090 Programmer with Conexus Telemetry is used. For
information about using the Medtronic CareLink Model 2090 Programmer without Conexus
Telemetry, see the Medtronic CareLink Model 2090 Programmer Reference Guide.
Manual conventions
Throughout this document, the word “device” refers to the implanted Virtuoso 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].
Nomenclature for product battery life terms
This manual uses a nomenclature for certain terms related to product battery life as defined
in CENELEC pacemaker standard EN 45502-2-1:2003. This standard applies to Active
Implantable Medical Devices (AIMD) intended to treat bradyarrhythmias. This standard was
approved and published in December 2003.
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Medtronic has adopted this nomenclature to comply with the CENELEC standard and in
anticipation of the nomenclature becoming an international standard. The nomenclature
defined in EN 45502-2-1:2003 replaces previously used terms related to product battery
life.
The nomenclature defined in EN 45502-2-1:2003, and the terms this nomenclature
replaces, are presented in the following table:
Nomenclature in EN 45502-2-1: 2003 Previously used nomenclature
BOS Beginning of Service BOL Beginning of Life
EOS End of Service EOL End of Life
RRT Recommended Replacement Time ERI Elective Replacement Indicator
PSP Prolonged Service Period Post-ERI conditions
Projected service life Longevity projections
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.
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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.
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, DR devices
Table 1. Model D154AWG physical characteristics
Volume
Mass 68 g
H x W x D
Surface area of device can 59 cm
Radiopaque ID PVR
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
37 cm
64 mm x 51 mm x 15 mm
2
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Figure 1. Model D154AWG connector and suture holes
DR/VR D154AWG/D154VWC
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, RV
5 IS-1 connector port, A
6 Suture holes
1.2 Physical characteristics, VR devices
Table 2. Model D154VWC physical characteristics
Volume
a
Mass 68 g
H x W x D
b
Surface area of device can 59 cm
Radiopaque ID PVR
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.
Reference Manual 15
3
37 cm
64 mm x 51 mm x 15 mm
2
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Figure 2. Model D154VWC connector and suture holes
DR/VR D154AWG/D154VWC
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, RV
5 Suture holes
1.3 Replacement indicators
Battery voltage and messages about replacement status appear on the programmer display
and on printed reports. The Recommended Replacement Time (RRT) and the End of
Service (EOS) conditions are listed in Table 3.
Table 3. Replacement indicators
Recommended Replacement Time (RRT) ≤ 2.62 V on 3 consecutive daily automatic meas-
urements
End of Service (EOS) 3 months after RRT
RRT date – The programmer displays the date when the battery reached RRT on the Quick
Look and Battery and Lead Measurements screens.
Replace at EOS – If the programmer indicates that the device is at EOS, replace the device
immediately.
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Prolonged Service Period (PSP) conditions – The Prolonged Service Period (PSP) is
the time between the Recommended Replacement Time (RRT) and End of Service (EOS).
EOS device status is defined as 3 months following an RRT indication assuming the
following PSP conditions: 100% DDD pacing (VVI in VR devices) at 60 bpm; 2.5 V; 0.4 ms;
500 Ω pacing load; and 6 full-energy charges. EOS may be indicated before the end of 3
months if the device exceeds these conditions.
1.4 Projected service life
Projected service life estimates are based on accelerated battery discharge data and device
modeling as specified.
The projected service life of the device is affected by how certain features, such as
Pre-arrhythmia EGM storage, are programmed. See Section 4.12, “Optimizing device
longevity”, page 55.
1.4.1 DR projected service life projections
The projected service life estimates assume the default automatic capacitor formation
setting. As a guideline, each full-energy charge decreases the projected service life of the
device by approximately 37 days. The following table displays device projected service life
in years with 0.4 ms pulse width, and 60 bpm pacing rate.
Table 4. Projected service life
500 Ω pacing impe-
b
Maximum energy
% Pacing
DDD, 0% Semiannual 7.4 (9.4) 7.4 (9.4) 7.4 (9.4) 7.4 (9.4)
DDD, 15% Semiannual 7.1 (9.0) 7.1 (8.9) 7.3 (9.2) 7.2 (9.1)
DDD, 50% Semiannual 6.6 (8.1) 6.3 (7.8) 6.9 (8.6) 6.7 (8.4)
AAI<=>DDD,
(MVP mode)
50% atrial,
5% ventricular
charging frequency
Quarterly 6.6 (8.2) 6.6 (8.2) 6.6 (8.2) 6.6 (8.2)
Quarterly 6.4 (7.9) 6.3 (7.8) 6.5 (8.0) 6.5 (7.9)
Quarterly 6.0 (7.2) 5.8 (6.9) 6.2 (7.6) 6.1 (7.4)
Semiannual 7.0 (8.8) 6.9 (8.5) 7.2 (9.1) 7.1 (8.9)
Quarterly 6.3 (7.7) 6.2 (7.5) 6.5 (7.9) 6.4 (7.8)
dance
a
2.5 V 3.0 V 2.5 V 3.0 V
900 Ω pacing impe-
b
dance
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Table 4. Projected service life (continued)
500 Ω pacing impe-
b
dance
a
2.5 V 3.0 V 2.5 V 3.0 V
% Pacing
Maximum energy
charging frequency
DDD, 100% Semiannual 5.9 (7.1) 5.5 (6.6) 6.5 (7.9) 6.2 (7.5)
Quarterly 5.4 (6.4) 5.1 (6.0) 5.9 (7.1) 5.6 (6.7)
a
Maximum energy charging frequency may include full-energy therapy shocks or capacitor formations. Additional
full-energy charges due to therapy shocks, device testing, or capacitor formation reduce longevity by
approximately 37 days (0.10 year).
b
The first data values provided assume that Pre-arrhythmia EGM is programmed On Continuous for the life of
the device, which is both the Shipped and nominal value for that parameter. The data values provided in
parentheses assume that Pre-arrhythmia EGM storage is programmed Off for the life of the device, which
lengthens projected service life by 23% or 2.8 months per year.
900 Ω pacing impe-
b
dance
1.4.2 VR projected service life projections
The projected service life estimates assume the default automatic capacitor formation
setting. As a guideline, each full-energy charge decreases the projected service life of the
device by approximately 44 days. The following table displays device projected service life
in years with VVI pacing mode, 0.4 ms pulse width, and 60 bpm pacing rate.
Table 5. Projected service life
500 Ω pacing impe-
b
dance
a
2.5 V 3.0 V 2.5 V 3.0 V
% Pacing
Maximum energy
charging frequency
0% Semiannual 8.3 (10.8) 8.3 (10.8) 8.3 (10.8) 8.3 (10.8)
Quarterly 7.3 (9.2) 7.3 (9.2) 7.3 (9.2) 7.3 (9.2)
15% Semiannual 8.1 (10.5) 8.0 (10.5) 8.2 (10.7) 8.1 (10.6)
Quarterly 7.2 (9.0) 7.1 (9.0) 7.2 (9.1) 7.2 (9.1)
50% Semiannual 7.7 (9.9) 7.6 (9.7) 7.9 (10.3) 7.8 (10.1)
Quarterly 6.9 (8.6) 6.7 (8.4) 7.1 (8.8) 7.0 (8.7)
100% Semiannual 7.2 (9.2) 7.0 (8.7) 7.6 (9.8) 7.4 (9.5)
Quarterly 6.5 (8.0) 6.3 (7.6) 6.8 (8.5) 6.7 (8.2)
a
Maximum energy charging frequency may include full-energy therapy shocks or capacitor formations. Additional
full-energy charges due to therapy shocks, device testing, or capacitor formation reduce longevity by
approximately 44 days (0.12 year).
b
The first data values provided assume that Pre-arrhythmia EGM is programmed On Continuous for the life of
the device, which is both the Shipped and nominal value for that parameter. The data values provided in
parentheses assume that Pre-arrhythmia EGM storage is programmed Off for the life of the device, which
lengthens projected service life by 27% or 3.3 months per year.
900 Ω pacing impe-
b
dance
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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: When a monitor alert condition has occurred, a magnet placed near the device will
cause the device to emit a high/low dual tone regardless of how the device alert is
programmed.
Table 6. Effects of magnet application on the device
Pacing mode As programmed
Pacing rate and interval As programmed
Tachyarrhythmia detection Suspended
Medtronic CareAlert audible tones
(10 s or less)
c
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)
a
Rate Response adjustments are suspended while a Medtronic CareAlert tone sounds.
b
During a wireless communication session, tachyarrhythmia detection remains suspended if a magnet (or the
programming head) is placed over the device. During a conventional telemetry session, tachyarrhythmia
detection is suspended when the programming head or a magnet is placed over the device, but detection
resumes if telemetry between the device and programmer is established.
c
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.
a
b
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).
Table 7. Average full energy charge times at BOS and RRT (2.62 V)
At Beginning of Service (BOS) 8.2 s
At Recommended Replacement Time (RRT) 9.8 s (DR devices)
10.0 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.
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Table 8. Programmed (delivered) and stored energy levels
a
Energy (J) Energy (J)
Programmed/
Delivered
a
Stored
a
Charge
Time (s)
Programmed/
b
Delivered
a
Stored
a
Charge Time
b
(s)
35 39 8.2 9 10.5 2.1
32 37 7.5 8 9.3 1.9
30 34 7.0 7 8.2 1.6
28 32 6.6 6 7.1 1.4
26 30 6.1 5 5.9 1.2
25 29 5.9 4 4.8 0.9
24 27 5.6 3 3.6 0.7
22 25 5.2 2 2.4 0.5
20 23 4.7 1.8 2.2 0.4
18 21 4.2 1.6 2.0 0.4
16 19 3.7 1.4 1.7 0.3
15 17 3.5 1.2 1.5 0.3
14 16 3.3 1.0 1.2 0.2
13 15 3.0 0.8 1.0 0.2
12 14 2.8 0.6 0.8 0.1
11 13 2.6 0.4 0.5 0.1
10 12 2.3
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 Service (BOS) with fully-formed capacitors, rounded to the nearest tenth of
a second.
1.8 Stored data and diagnostics
Table 9. Arrhythmia episode data storage
Episode data type DR devices VR devices
Treated VT/VF episode log entries 100 entries 100 entries
Treated VT/VF episode EGM, markers, and
intervals
Monitored VT episode log entries 15 entries 15 entries
Monitored VT episode EGM, markers, and
intervals
Non-sustained VT episode log entries 15 entries 15 entries
Non-sustained VT episode EGM, markers, and
intervals
Treated AT/AF episode log entries 100 entries —
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9.25 min 13.75 min
45 s 51 s
30 s 30 s
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Table 9. Arrhythmia episode data storage (continued)
Episode data type DR devices VR devices
Treated AT/AF episode EGM, markers, and
3.75 min —
intervals
Monitored AT/AF episode log entries 50 entries —
Monitored AT/AF episode EGM, markers, and
1.0 min —
intervals
SVT episode log entries 25 entries 25 entries
SVT episode EGM, markers, and intervals 1.25 min 1.4 min
Patient activated episode log entries 50 entries 50 entries
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 A- and V-events)
2000 events (includes
both A- and V-events)
2000 events (V-events
only)
—
Table 10. VT/VF episode counters
Counter data type 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
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Table 11. VT/VF therapy counters
Counter data type 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
Table 12. AT/AF episode counters
Counter data type DR devices
AT/AF summary data
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
episodes in this counter may exceed the number of detected AT/AF episodes recorded by the device.
●
Percent of time in AT/AF
●
Average time in AT/AF per day
●
Percentage of AT/AF episodes terminated by ATP
●
Monitored AT/AF
●
Treated AT/AF
●
Non-sustained AT
●
Atrial pacing
●
Atrial intervention pacing
●
Grouped by duration
●
Grouped by start time
a
a
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Table 13. AT/AF therapy counters
Counter data type DR devices
Number of AT/AF episodes treated
and the percentage terminated,
●
Grouped by detection zone and therapy
●
Grouped by atrial cycle length
presented in different groupings
Counts of different AT/AF therapy
types
●
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
Table 14. Battery and lead measurement data
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 results
●
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
DR/VR D154AWG/D154VWC
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.
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
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Table 16. Cardiac Compass trend data
Printed report showing up to 14 months of measurement trends and summary data.
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
●
Thoracic impedance
●
Accumulated differences between the daily
●
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
●
Thoracic impedance
●
Accumulated differences between the daily
and reference thoracic impedance (OptiVol
fluid index)
and reference thoracic impedance (OptiVol
fluid index)
Table 17. Rate Histograms report
Data type 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 ven-
a
tricular sensing
●
Ventricular pacing and ventricular sensing during
AT/AF
Percent of time for each event
b
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 DR devices, if the programmed pacing mode during the reporting period was a dual chamber mode, 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
●
Ventricular pacing and ventricular sensing
●
VP events
●
VS events
Table 18. Medtronic CareAlert event data
Log of events that triggered Medtronic CareAlert notifications. Each log entry includes the following
information:
●
Date when the event first occurred (since the last interrogation)
●
Description of event that triggered the Medtronic CareAlert notification
●
Programmed threshold for the Medtronic CareAlert notification, if applicable
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2 The Virtuoso system
2.1 System overview
Virtuoso 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
Virtuoso DR device also detects and treats atrial tachyarrhythmia episodes.
Each Virtuoso ICD system includes 5 major components: the implanted device, the leads
connecting the device to the patient’s heart, the Medtronic programmer with Virtuoso
application software installed, the Conexus Activator, and the Medtronic CareLink Monitor.
The system uses Conexus wireless telemetry for communication between the device and
programmer and between the device and patient’s monitor.
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. 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.
Note: OptiVol fluid monitoring may be adversely affected by the use of an epicardial
defibrillation lead instead of an RVcoil (HVB) lead.
1
With an appropriate unipolar to bipolar adapter kit.
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2.1.3 Programmer and software
The Medtronic programmer and Virtuoso 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
The Virtuoso devices and application software are compatible with the following
programmer systems:
●
Medtronic CareLink Model 2090 programmer with Conexus Telemetry
●
Medtronic CareLink Model 2090 programmer with a Model 2067 or 2067L programming
head
2.1.4 Network connectivity and data exchange
The system supports network connectivity and the exchange of data between the Medtronic
Carelink 2090 programmer and the Medtronic Paceart data management system using the
SessionSync feature.
The system supports the use of the Medtronic 2290 Analyzer, which allows you to have a
device session and an analyzer session running at the same time, quickly switch from one
to the other without having to end or restart sessions, and export data from the analyzer to
the device software application.
The system supports Remote View, which allows you to use a personal computer in your
office or elsewhere to view the screen displays from a Medtronic CareLink programmer in
a clinic, hospital, or other location.
2.1.5 Conexus wireless telemetry
Conexus wireless telemetry is designed to provide clinicians and patients with an easier
and more efficient implant, follow-up, and monitoring experience. The system uses radio
frequency (RF) telemetry for wireless communication between the implanted device and
programmer in the hospital or clinic, and between the implanted device and the patient’s
monitor. This eliminates the need to have a programming head over the implanted device
for the duration of a programming or monitoring session.
2.1.6 Conexus Activator
The Medtronic Model 27901 Conexus Activator can be used by clinicians to turn on Conexus
wireless telemetry for implanted devices that support wireless telemetry.
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2.1.7 Monitor
The patient’s monitor remotely interrogates device parameter settings, episode data, device
status data, and patient data from the patient’s device. When a patient receives their
monitor, they must perform a manual interrogation session to initialize their monitor to their
device. This initialization ensures that the patient’s device and the patient’s monitor will only
be able to transmit information between one another.
2.1.8 Patient assistant
Patients can use the Model 2696 InCheck Patient Assistant to perform the following
functions:
●
Verify whether the implanted device has detected a suspected atrial tachyarrhythmia
(DR devices only).
●
Initiate recording of cardiac event data in the device memory (both DR and VR devices).
●
Request delivery of atrial cardioversion therapy (if the device is programmed to allow
patient-activated cardioversion) (DR devices only).
Note: Patient-activated cardioversion is only delivered if the implanted device is
currently detecting an AT/AF episode.
2.1.9 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.
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.
2.1.10 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.
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Medtronic VIRTUOSO
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.
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.
®
DR/VR D154AWG/D154VWC
2.1.11 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. DR devices can detect AT/AF episodes, and respond
to detected AT/AF episodes with programmed atrial tachyarrhythmia therapies. DR 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.
2.1.12 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.
2.1.13 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. 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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2.1.14 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, bradycardia pacing activities, and thoracic
fluid trends. The Rate Histograms report shows the percent of time that cardiac events
occurred at different heart rates. In 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.
2.1.15 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.
2.1.16 Alerting the patient to system events
You can use the programmable Medtronic CareAlert monitoring feature to notify the patient
with audible tones if certain conditions occur that are related to the leads, battery, charge
time, and therapies. The patient can then respond based on your prescribed instructions.
The patient’s monitor can then notify the patient or a family member of certain event
conditions.
2.2 Indications and usage, DR devices
The device is indicated to provide ventricular antitachycardia pacing and ventricular
defibrillation for automated treatment of life-threatening ventricular arrhythmias. In addition,
the device is indicated for use in patients with atrial tachyarrhythmias, or those patients who
are at significant risk of developing atrial 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, VR devices
The device is indicated to provide ventricular antitachycardia pacing and ventricular
defibrillation for automated treatment of life-threatening ventricular arrhythmias.
2.4 Contraindications, DR 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, drug 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, 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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