Medtronic 7289 Reference Guide
INSYNC II MARQUIS™ 7289
Dual Chamber Implantable Cardioverter Defibrillator with
Cardiac Resynchronization Therapy
Reference Manual
Caution: Federal Law (USA) restricts this device to sale by or on
the order of a physician (or properly licensed practitioner).
InSync II Marquis
7289
Reference Manual 0
A guide to the operation and programming
of the Model 7289 InSync II Marquis Dual Chamber
Implantable Cardioverter Defibrillator with
Cardiac Resynchronization Therapy
0
The following are trademarks of Medtronic:
Active Can
Leadless™ ECG, Marker Channel, INSYNC
®
, Cardiac Compass, CareLink, Checklist, Flashback®,
®
, MARQUIS, Patient Alert,
PR Logic, Quick Look, QuickLink, RapidRead
Table of contents
Introduction 11
Abbreviations and acronyms 14
Part I Quick overview
1 Quick reference 19
Physical characteristics 20
Magnet application 21
Projected longevity 22
Replacement indicators 24
Typical charge times 25
High voltage therapy energy 25
Stored data and diagnostics 26
New and enhanced features 29
2 The InSync II Marquis system 31
System overview 32
Indications and usage 35
Contraindications 36
Patient screening 36
3 Emergency therapy 37
Delivering emergency therapies 38
Part II Device implant and patient follow-up procedures
4 Implanting the device 45
Overview 46
Preparing for an implant 46
Replacing an ICD 48
Surgical approach 49
Sensing and pacing measurements 53
Connecting the leads to the device 54
Testing defibrillation operation and effectiveness 57
Positioning and securing the device 62
InSync II Marquis 7289 Reference Manual
6
Table of contents
Completing the implant procedure 63
5 Conducting a patient follow-up session 65
Patient follow-up guidelines 66
Verifying the status of the implanted system 66
Verifying effective cardiac resynchronization therapy 67
Verifying effective basic pacing 68
Verifying accurate detection and appropriate therapy for
ventricular tachyarrhythmias 69
Part III Configuring the device for the patient
6 Detecting tachyarrhythmias 73
Detection overview 74
Setting up sensing 77
Detecting VF episodes 83
Detecting VT episodes 88
Detecting FVT episodes 94
Detecting tachyarrhythmia episodes with Combined Count 99
Monitoring episodes for termination or redetection 102
Enhancing detection with PR Logic criteria 106
Enhancing VT detection with the Stability criterion 115
Detecting double tachycardias 118
Detecting prolonged tachyarrhythmias with
High Rate Timeout 119
Key terms 121
7 Treating tachyarrhythmia episodes 127
Treating VF with defibrillation 128
Treating VT and FVT with antitachycardia pacing 138
Treating VT and FVT with cardioversion 148
Optimizing therapy with Smart Mode and Progressive Episode
Therapies 157
Key terms 161
8 Treating ventricular dysynchrony and bradycardia 165
Providing basic pacing therapy 166
Dual chamber pacing 174
InSync II Marquis 7289 Reference Manual
Table of contents
Single chamber pacing 185
Promoting continuous CRT delivery 189
Rate adjustments to optimize cardiac output 200
Managing atrial tracking to optimize A-V synchrony 211
Providing Ventricular Safety Pacing 223
Key terms 226
9 Optimizing charge time and device longevity 231
Optimizing charge time 232
Optimizing device longevity 235
Key terms 236
Part IV Evaluating and managing patient treatment
10 Using the programmer 239
Connecting the programmer hardware 240
Using an external printer 241
Using the programming head 246
Display screen features 247
Setting programmer preferences 254
Starting and ending patient sessions 258
Viewing live waveforms 261
Recording live waveforms 268
Saving and retrieving device data 270
Printing reports 274
Key terms 277
11 Using system evaluation tools 279
A summary of system evaluation tools 280
Taking a quick look at device activity 281
Using the Patient Alert feature 283
Streamlining follow-ups with Checklist 291
Key terms 294
7
12 Setting up and viewing collected data 295
A summary of data collection 296
Viewing battery and lead status data 298
Printing rate histograms 303
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8
Table of contents
Viewing the Heart Failure Management report 306
Viewing clinical trends in the Cardiac Compass report 310
Viewing the episode and therapy efficacy counters 318
Viewing episode data 322
Viewing Flashback Memory 332
Setting up data collection 334
Viewing and entering patient information 340
Automatic device status monitoring 343
Key terms 345
13 Testing the system 349
Testing overview 350
Evaluating the underlying rhythm 350
Measuring pacing thresholds 351
Measuring lead impedance 354
Measuring EGM amplitude 356
Testing the device capacitors 358
Key terms 360
14 Conducting Electrophysiologic Studies 361
EP Study overview 362
Inducing VF with T-Shock 364
Inducing VF with 50 Hz Burst 367
Inducing an arrhythmia with Manual Burst 370
Inducing an arrhythmia with PES 373
Delivering a manual therapy 376
Key terms 379
15 Solving system problems 381
Overview 382
Solving cardiac resynchronization therapy problems 383
Solving sensing problems 386
Solving tachyarrhythmia detection problems 388
Solving tachyarrhythmia therapy problems 389
Responding to device status indicators 391
Key terms 392
InSync II Marquis 7289 Reference Manual
Part V Appendices
A Warnings and precautions 397
Warnings 398
Precautions 399
B Device parameters 409
Emergency settings 410
Pacing parameters 411
Detection parameters 414
Therapy parameters 416
System maintenance parameters 418
Data collection parameters 419
System test and EP study parameters 421
Fixed parameters 424
Patient information parameters 426
Programmer symbols 427
Parameter interlocks 429
C Device Programming Recommendations 431
Device programming recommendations 432
D Medtronic CareLink Programmer Model 2090 435
Introduction 436
Software feature update 436
Table of contents
9
Index 439
InSync II Marquis 7289 Reference Manual
10
Table of contents
InSync II Marquis 7289 Reference Manual
Introduction
Using this manual
Before implanting the device, it is strongly recommended that you:
■
Refer to the product literature packaged with the device for
information about prescribing the device.
■
Thoroughly read this manual and the technical manuals for the
leads and the implant tools used with the device.
■
Discuss the procedure and the device system with the patient
and any other interested parties, and provide them with any
patient information packaged with the device.
Required Physician Training
If a physician is not familiar with implantation or follow-up of
Implantable Cardioverter Defibrillators (ICDs) with cardiac
resynchronization systems, the physician is required to:
1. Thoroughly read this manual, and all associated device and/or lead
technical manuals.
2. Provide a copy of the patient manual to the patient and discuss it
with him or her and any other interested parties.
3. Be trained on the following topics:
■
Indications for use.
■
Device operation to ensure therapy delivery.
■
Measuring and managing biventricular thresholds.
■
Assembly and use of LV lead implant tools.
■
Placement of the LV lead.
■
Patient management and system follow-up.
Introduction
11
Medtronic will certify that physicians are trained prior to implanting
the system.
InSync II Marquis 7289 Reference Manual
12
Introduction
Contacting technical support
References
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 medical
consultation, Medtronic can often refer product users to outside
medical consultants with appropriate expertise.
For more information, contact your local Medtronic representative,
or call or write Medtronic at the appropriate address or telephone
number listed on the back cover.
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:
■
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.
■
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.
InSync II Marquis 7289 Reference Manual
Notice
Introduction
This software is provided as an informational tool for the end user.
The user is responsible for accurate input of patient information
into the software. Medtronic makes no representation as to the
accuracy or completeness of the data input into the software.
MEDTRONIC SHALL NOT BE LIABLE FOR ANY DIRECT,
INDIRECT, INCIDENTIAL OR CONSEQUENTIAL DAMAGES TO
ANY THIRD PARTY WHICH RESULTS FROM THE USE OF THE
INFORMATION PROVIDED IN THE SOFTWARE.
13
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14
Introduction
Abbreviations and acronyms
A Atrial
AF Atrial Fibrillation
AFib/AFlutter Atrial Fibrillation and/or Atrial Flutter
AFR Conducted AF Response
ARP Atrial Refractory Period
ATR Atrial Tracking Recovery
ATP Antitachycardia Pacing
AVP Atrial Vulnerable Period
BOL Beginning of Life
bpm beats per minute
CNID Combined (VT and VF) Number of Intervals to Detect
CRT Cardiac Resynchronization Therapy
CV Cardioversion
DF/Defib Defibrillation
ECG Electrocardiogram
EGM Electrogram
EOL End of Life
ERI Elective Replacement Indicator
FDI Fibrillation Detection Interval
FTI Fast Ventricular Tachycardia Detection Interval
FVT Fast Ventricular Tachycardia
ICD Implantable Cardioverter Defibrillator
J joules
LV Left Ventricle
min
ms milliseconds
mV millivolts
NCAP Non-Competitive Atrial Pacing
NID Number of Intervals to Detect
NST Non-sustained Tachycardia
PAC Premature Atrial Contraction
PAV Paced A-V Delay
PES Programmed Electrical Stimulation
PMT Pacemaker-Mediated Tachycardia
P-P an atrial interval
ppm paces or pulses per minute
-1
reciprocal minutes; for example, pacing pulses per minute
InSync II Marquis 7289 Reference Manual
Introduction
P-R an interval between a P-wave and the subsequent R-wave
PVAB Post Ventricular Atrial Blanking period
PVARP Post Ventricular Atrial Refractory Period
PVC Premature Ventricular Contraction
RAAV Rate Adaptive A-V delay
RNID Number of Intervals to Redetect
R-P an interval between an R-wave and the subsequent P-wave
R-R a ventricular interval
RV Right Ventricle
SAV Sensed A-V Delay
ST/Sinus Tach Sinus Tachycardia
SVT Supraventricular Tachycardia
TARP Total Atrial Refractory Period
TDI Tachycardia Detection Interval
V volts
V Ven tr icular
VF Ventricular Fibrillation
VF NID VF Number of Intervals to Detect
VRS Ventricular Rate Stabilization
VSP Ventricular Safety Pacing
VSR Ventricular Sense Response
VT Ventricular Tachycardia
VT NID VT Number of Intervals to Detect
15
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16
Introduction
InSync II Marquis 7289 Reference Manual
Quick overview
Part I
InSync II Marquis 7289 Reference Manual
Physical characteristics 20
Magnet application 21
Projected longevity 22
Replacement indicators 24
Typical charge times 25
High voltage therapy energy 25
Stored data and diagnostics 26
New and enhanced features 29
Quick reference1
1
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20
Chapter 1
Physical characteristics
Physical characteristics
Table 1-1. InSync II Marquis physical characteristicsa
Volume 38 cc
b
Mass 77 g
c
H x W x D
Surface area of device can 66 cm
Radiopaque IDd
Materials in contact with
human tissue
e
73 mm x 51 mm x 13.9 mm
2
PLU
Titanium / polyurethane / silicone rubber /
silicone adhesive
Battery Lithium silver vanadium oxide
Connectors Three IS-1 connectors for pacing and
sensing, Two DF-1 connectors for high
voltage therapy, Active Can electrode
(programmable)
A
RV RV (HVB)
LV
Can
SVC (HVX)
Device
Port
SVC (HVX) DF-1 HVX
RV (HVB) DF-1 HVB
Can n/a HVA
RV IS-1bipolar RVtip and
Connector
Type
Software
Names
RVr ing
LV IS-1bipolar LVtip and
LV r in g
A IS-1 bipolar Atip and Aring
Suture holes
a
Measurements are nominal values based on CAD (computer aided design)
model measurements and are rounded to the nearest unit.
b
Volume with connector holes unplugged.
c
Grommets may protrude slightly beyond the can surface.
d
Engineering series number follows the radiopaque code.
e
These materials have been successfully tested and verified for biocompatibility.
The device does not produce an injurious temperature in the surrounding tissue.
InSync II Marquis 7289 Reference Manual
Magnet application
Bringing a magnet close to the device triggers changes in device
operation as shown in Table 1-2. When the magnet is removed,
the device returns to its programmed operations.
For information on demonstrating Patient Alert tones to the
patient, see “Instructing the patient” on page 288.
Table 1-2. Effects of magnet application on the device
Pacing mode as programmed
Pacing rate and interval as programmed
VF, VT, and FVT detection suspended
Patient Alert audible tones
(20 seconds or less)
a
Rate response adjustments are suspended while a Patient Alert tone sounds.
b
Detection resumes if telemetry is established and the application software is
running, or it resumes after the application software has started.
c
Or “VF Detection/Therapy Off” is the only alert enabled.
Quick reference
Magnet application
a
b
■
high/low dual tone
(high urgency alert occurred)
■
on/off intermittent tone
(lower urgency alert occurred)
■
continuous test tone
(no alert occurred)
■
no tone
(alerts are disabled)
c
21
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22
Chapter 1
Projected longevity
Projected longevity
Longevity estimates are based on accelerated battery discharge
data and device modeling, EGM pre-storage off, with:
■
2.5 V atrial and RV pacing amplitude, 3 V LV pacing amplitude,
0.4 ms pulse widths, and 30 J delivered therapy energy
(see Table 1-3)
■
3 V atrial and RV pacing amplitude, 4 V LV pacing amplitude,
0.4 ms pulse widths, and 30 J delivered therapy energy
(see Table 1-4)
Considerations for using EGM pre-storage – When the EGM
pre-storage feature is programmed off, the device starts to store
EGM following the third tachyarrhythmia event and also provides
up to 20 seconds of information before the onset of the
tachyarrhythmia, including:
■
AA and VV intervals
■
Marker Channel
■
interval plot Flashback
When the EGM pre-storage feature is programmed on, the device
also collects up to 20 seconds of EGM information before the
onset of the arrhythmia.
In a patient who uniformly repeats the same onset mechanisms,
the greatest clinical benefit of pre-onset EGM storage is achieved
after a few episodes are captured. To maximize the effectiveness
of the EGM pre-storage feature and optimize device longevity,
consider these programming options:
■
Turn pre-storage on to capture possible changes in the onset
mechanism following significant clinical adjustments, for
example, device implant, medication changes, and surgical
procedures.
■
Turn pre-storage off once you have successfully captured the
information of interest.
InSync II Marquis 7289 Reference Manual
Quick reference
Projected longevity
Table 1-3. InSync II Marquis projected estimated longevity in years with 2.5 V atrial and right
ventricular pacing amplitude, 3 V left ventricular pacing amplitude, and 0.4 ms pulse width; DDDR
mode, 100% biventricular pacing with atrial tracking at 70 bpm (min-1).
Maximum energy charging
frequency (30 J)
a
500 ohm pacing
impedance
700 ohm pacing
impedance
Semi-Annual 4.9 5.2
Quarterly 4.5 4.8
a
Maximum energy charging frequency may include full energy therapy shocks or capacitor formations.
Table 1-4. InSync II Marquis projected estimated longevity in years with 3 V atrial and right
ventricular pacing amplitude, 4 V left ventricular pacing amplitude, and 0.4 ms pulse width; DDDR
mode, 100% biventricular pacing with atrial tracking at 70 bpm (min
Maximum energy charging
frequency (30 J)
a
500 ohm pacing
impedance
-1
).
700 ohm pacing
impedance
Semi-Annual 4.2 4.6
Quarterly 3.9 4.3
a
Maximum energy charging frequency may include full energy therapy shocks or capacitor formations.
The longevity of the device is dependent on several factors. The
following factors result in decreased longevity:
■
an increase in pacing rate, pacing amplitude or pulse width;
the ratio of paced to sensed events; or the charging frequency
■
a decrease in pacing impedance
■
using the pre-onset EGM storage feature or Holter telemetry
23
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24
Chapter 1
Replacement indicators
Replacement indicators
Battery voltage and messages about replacement status appear
on the programmer display and on printed reports. Table 1-5 lists
the Elective Replacement Indicator (ERI) and the End of Life
(EOL) conditions.
Table 1-5. Replacement indicators
Elective Replacement (ERI) ≤ 2.62 V
End of Life (EOL) 3 months after ERI
ERI date – The programmer displays the date when the battery
reached ERI on the Quick Look and Battery and Lead
Measurements screens.
Temporary voltage decrease – The battery voltage temporarily
decreases following a high voltage charge. If a battery
measurement is taken immediately after a high voltage charge,
the ERI or EOL indicator may be displayed. However, this is a
temporary status which will return to normal when the battery has
recovered from the charge.
EOL indication – If the programmer indicates that the device is at
EOL, replace the device immediately.
Post-ERI conditions – EOL device status is defined as three
months following an ERI indication assuming the following
post-ERI conditions: 0% DDD atrial pacing, 100% DDD RV and LV
pacing at 70 ppm (min
for LV; 500 Ω pacing load; and six 30 J charges. EOL may be
indicated before the end of three months if the device exceeds
these conditions.
InSync II Marquis 7289 Reference Manual
-1
), 3 V, 0.4 ms for atrial and RV, 4 V, 0.4 ms
Typical charge times
The most recent capacitor charge time appears on the
programmer display and on printed reports and can be evaluated
using the Charge/Dump test (see Table 1-6).
Ta bl e 1 -6 . Ty pi c ala full energy charge times
At Beginning of Life (BOL) 5.9 seconds
At Elective Replacement (ERI) 7.5 seconds
a
These charge times are typical when the capacitors are fully formed.
High voltage therapy energy
The stored energy of the device is derived from the peak capacitor
voltage and is always greater than the energy delivered by the
device. Table 1-7 compares the programmed energy levels
delivered by the device to the energy levels stored in the
capacitors before delivery.
Quick reference
Typical charge times
25
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26
Chapter 1
Stored data and diagnostics
Table 1-7. Comparing delivereda (programmed) and storedb energy levels
Energy (J) Charge
Delivered a/
Stored
Programmed
30 35 5.9 8 9.4 1.6
28 33 5.6 7 8.3 1.4
26 31 5.2 6 7.1 1.2
24 28 4.7 5 5.9 1.0
22 26 4.4 4 4.7 0.8
20 24 4.0 3 3.6 0.6
18 21 3.5 2 2.4 0.4
16 19 3.2 1.8 2.2 0.4
15 18 3.0 1.6 2.0 0.3
14 16 2.7 1.4 1.7 0.3
13 15 2.5 1.2 1.5 0.3
12 14 2.4 1.0 1.2 0.2
11 13 2.2 0.8 1.0 0.2
10 12 2.0 0.6 0.8 0.1
911 1.9 0.40.5 0.1
a
Energy delivered at connector block into a 75 ohm load.
b
Energy stored on capacitor at end of charge.
c
Typical charge time at Beginning of Life (BOL) with fully formed capacitors, rounded to the nearest tenth
of a second.
b
Timec(sec)
Delivered a/
Programmed
Energy (J) Charge
Timec (sec)
b
Stored
Stored data and diagnostics
Table 1-8. Stored data and diagnostics
Episode data
Tachy episodes 150 VF/VT/FVT episodes: intervals, text, EGM
EGM capacity for
tachy episodes
SVT/NST episodes 50 SVT/NST episodes: intervals, text, EGM (the
InSync II Marquis 7289 Reference Manual
14 minutes of dual-channel EGM, or
23.5 minutes of single-channel EGM
device does not usually store detailed episode
records for NST episodes)
Quick reference
Stored data and diagnostics
Table 1-8. Stored data and diagnostics (Continued)
EGM capacity for
SVT/NST episodes
EGM sources 14 options: atrial / RV / LV / far-field
EGM options Store before onset; Store during charging
Flashback memory 2000 intervals and markers (containing both
Mode switch episodes 53 mode switch episodes (fastest, longest, first,
Ventricular sensing
episodes
Counter data
Detection counters Lifetime total, since cleared, and since last
Episode counters Episodes:
2 minutes of dual-channel EGM, or 3.6 minutes
of single-channel EGM
A-A and V-V): before latest VF, before latest VT,
and before interrogation
and 50 latest): episode text
9 ventricular sensing episodes (longest, first,
and 7 latest): intervals, markers, and counter
data text
session
■
VF, FVT, and VT
■
Atrial Fibrillation / Atrial Flutter episodes
■
Sinus Tach episodes
■
Other 1:1 SVT episodes
■
NST episodes
■
Mode switch episodes
Percentage pacing:
■
AS-VS, AS-VP, AP-VS, AP-VP percentages
Additional counters:
■
Single PVCs and PVC runs
■
Rate stabilization pulses and runs
27
Therapy efficacy
counters
Counts for each VF, FVT, VT Therapy:
■
Delivered
■
Successful
■
Unsuccessful
■
Intervention (manually aborted)
Total number of aborted shocks
Other stored data
Patient Alert events Up to 10 log entries: text and date for the first
time an alert is triggered between interrogations
InSync II Marquis 7289 Reference Manual
28
Chapter 1
Stored data and diagnostics
Table 1-8. Stored data and diagnostics (Continued)
Battery and lead
measurements
Lead performance
trends
Rate histograms
Cardiac Compass
trends
Battery voltage, last capacitor formation, last
charge, lead impedance, EGM amplitude
measurements, last high voltage therapy, and
sensing integrity counter
14 days of daily measurements plus 80 weeks
of weekly minimum and maximum
measurements:
■
Lead impedance: atrial pacing, RV pacing,
LV pacing, defibrillation pathway, and SVC
lead (if used)
■
EGM amplitude: atrial (P-waves),
RV (R-waves)
■
Atrial rate
■
Ventricular rate
■
Ventricular rate during AT/AF
14 months of daily measurements:
■
VT and VF episodes per day
■
One or more high voltage therapy delivered
■
Ventricular rate during VT or VF
■
Episodes of non-sustained tachycardia
per day
■
Heart rate variability
■
Total daily time in AT/AF
■
Ventricular rate during AT/AF
■
Percent pacing per day
■
Patient activity
■
Average day and night ventricular
heart rate
InSync II Marquis 7289 Reference Manual
New and enhanced features
The following features are new or changed from the
7277 InSync Marquis ICD.
Patient management
Heart Failure Management Report – The HF report provides
counter, audit, and long term trend information about clinical
status and device operation. Topics include tachyarrhythmia
episodes, heart rate, percent pacing, and patient activity.
Rate Histograms Report – Rate histograms for atrial rate,
ventricular rate, and ventricular rate during AT/AF episodes are
provided upon interrogation.
Ventricular Sensing Episodes – This diagnostic tool provides
reports on extended periods of ventricular sensing to help the
clinician assess continuity of CRT delivery.
Quick reference
New and enhanced features
29
Cardiac resynchronization therapy
CRT recovery options – Three optional CRT features help to
maintain CRT:
■
Ventricular Sense Response provides ventricular pacing
in response to ventricular sensing to ensure that CRT
pacing is delivered as programmed.
■
Conducted AF Response dynamically adjusts and
smooths the pacing rate to maintain ventricular pacing
during conducted AT/AF episodes. (Conducted AF
Response does not provide therapy for atrial arrhythmias.)
■
Atrial Tracking Recovery temporarily shortens PVARP to
restore atrial tracking and CRT delivery when atrial events
fall in the refractory period following a sensed ventricular
event.
InSync II Marquis 7289 Reference Manual
30
Chapter 1
New and enhanced features
Other features
Independently programmable pacing outputs – Pacing
outputs for RV and LV are independently programmable
True bipolar RV sensing – Both integrated and true bipolar RV
sensing are available.
Programmable LV pacing vector – LV pacing can be delivered
from LVtip to LVring when a bipolar LV lead is implanted.
LV lead evaluation tools – The InSync II Marquis device
provides new tools for specific monitoring of the left ventricular
lead:
■
LV lead impedance trend
■
Patient Alert for LV lead impedance out of range
Added EGM sources – RVring EGM sources are available in
addition to LVtip to LVring (for bipolar LV leads) and LVtip to SVC.
InSync II Marquis 7289 Reference Manual
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