Part IIDevice implant and patient follow-up procedures
4Implanting the ICD47
Overview48
Preparing for an implant48
Replacing an ICD50
Positioning the leads51
Testing sensing and pacing thresholds53
Connecting the leads to the ICD54
Testing defibrillation operation and effectiveness55
Positioning and securing the ICD58
Maximo DR 7278 Reference Manual
6
Table of contents
Completing the implant procedure59
5Conducting a patient follow-up session61
Patient follow-up guidelines62
Verifying the status of the implanted system62
Verifying accurate detection and appropriate therapy63
Verifying effective bradycardia pacing65
Part IIIConfiguring the ICD for the patient
6Detecting tachyarrhythmias69
Detection overview70
Setting up sensing73
Detecting VF episodes78
Detecting VT episodes82
Detecting FVT episodes88
Detecting tachyarrhythmia episodes with Combined Count93
Monitoring episodes for termination or redetection95
Enhancing detection with PR Logic criteria98
Enhancing VT detection with the Stability criterion108
Detecting double tachycardias111
Detecting prolonged tachyarrhythmias with
High Rate Timeout112
Key terms114
7Treating tachyarrhythmia episodes119
Treating VF with defibrillation 120
Treating VT and FVT with antitachycardia pacing 130
Treating VT and FVT with cardioversion 140
Optimizing therapy with Smart Mode and Progressive Episode
Therapies149
Key terms153
8Treating bradycardia157
Providing basic pacing therapy158
Dual-chamber pacing164
Single chamber pacing174
Enhancing pacing for optimal cardiac output177
Maximo DR 7278 Reference Manual
Table of contents
Adjusting the pacing rate with Mode Switch 190
Preventing competitive atrial pacing194
Detecting and preventing pacemaker-mediated
tachycardia199
Providing Ventricular Safety Pacing203
Providing pacing after high voltage therapies206
Key terms208
9Optimizing charge time and device longevity 213
Optimizing charge time 214
Optimizing device longevity217
Key terms218
Part IVEvaluating and managing patient treatment
10 Using the programmer 221
Setting up and using the programmer222
Display screen features 223
Viewing and programming device parameters230
Starting and ending patient sessions234
Viewing live waveform traces 236
Recording live waveform strips 243
Saving and retrieving device data245
Printing reports249
Key terms254
11 Using system evaluation tools 255
A summary of system evaluation tools256
Taking a quick look at device activity 257
Using the Patient Alert feature 259
Streamlining follow-ups with Checklist267
Key terms270
7
12 Setting up and viewing collected data 271
A summary of data collection 272
Setting up data collection 273
Collecting lead performance data278
Viewing the episode and therapy efficacy counters279
Maximo DR 7278 Reference Manual
8
Table of contents
Viewing episode data284
Viewing Flashback Memory 292
Viewing battery and lead status data 294
Viewing lead performance trends296
Using Cardiac Compass to view long term clinical trends298
Viewing and entering patient information305
Automatic device status monitoring308
Key terms311
13 Testing the system 315
Testing overview316
Evaluating the underlying rhythm 316
Measuring pacing thresholds317
Measuring lead impedance 320
Measuring EGM Amplitude 322
Testing the device capacitors324
Key terms326
14 Conducting Electrophysiologic Studies 327
EP Study overview328
Inducing VF with T-Shock330
Inducing VF with 50 Hz Burst 334
Inducing an arrhythmia with Manual Burst337
Inducing an arrhythmia with PES 340
Delivering a manual therapy 343
Key terms346
15 Solving system problems349
Overview 350
Solving sensing problems351
Solving tachyarrhythmia detection problems 353
Solving tachyarrhythmia therapy problems354
Solving bradycardia pacing problems 355
Responding to device status indicators357
Key terms358
Maximo DR 7278 Reference Manual
Part VAppendices
A Warning and precautions 363
General warnings 364
Storage and handling364
Resterilization365
Device implantation and ICD programming 365
Lead evaluation and lead connection367
Follow-up testing368
Explant and disposal 369
Medical therapy hazards 369
Home and occupational environments371
BDevice parameters373
Emergency settings 374
Detection parameters 375
Therapy parameters 377
Bradycardia pacing parameters 379
System maintenance parameters 382
Data collection parameters 383
System test and EP study parameters 384
Fixed parameters 387
Patient information parameters389
Programmer symbols390
Parameter interlocks 392
Table of contents
9
Index 393
Maximo DR 7278 Reference Manual
Introduction
Using this manual
Before implanting the ICD, it is strongly recommended that you:
■
Refer to the product literature packaged with the ICD for
information about prescribing the ICD.
■
Thoroughly read this manual and the technical manuals for the
leads used with the device.
■
Discuss the procedure and the ICD system with the patient
and any other interested parties, and provide them with any
patient information packaged with the ICD.
Contacting 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.
Introduction
11
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.
Customer education
Medtronic invites physicians to attend an education seminar on
the complete ICD system. The course includes indications for use,
an overview of ICD system functions, implant procedures, and
patient management.
Maximo DR 7278 Reference Manual
12
Introduction
References
Notice
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, 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.
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.
CNID Combined (VT and VF) Number of Intervals to Detect
CV Cardioversion
DF/Defib Defibrillation
ECG Electrocardiogram
Introduction
13
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
-1
reciprocal minutes; for example, pacing pulses per minute
min
ms milliseconds
mV millivolts
NCAP Non-Competitive Atrial Pacing
NID Number of Intervals to Detect
NST Non-Sustained Tachycardia
Maximo DR 7278 Reference Manual
14
Introduction
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
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
SAV Sensed A-V Delay
ST/Sinus Tach Sinus Tachycardia
SVT Supraventricular Tachycardia
TDI Tachycardia Detection Interval
V volts
V- Ve n tr ic ul ar
VF Ventricular Fibrillation
VF NID VF Number of Intervals to Detect
VRS Ventricular Rate Stabilization
VSP Ventricular Safety Pacing
VT Ventricular Tachycardia
VT NID VT Number of Intervals to Detect
Maximo DR 7278 Reference Manual
Quick overview
Part I
Maximo DR 7278 Reference Manual
Physical characteristics 18
Magnet application 19
Longevity projections19
Replacement indicators22
Typical charge times23
High voltage therapy energy 23
Stored data and diagnostics25
New and enhanced features 27
Quick reference1
1
Maximo DR 7278 Reference Manual
18
Chapter 1
Physical characteristics
Physical characteristics
Table 1-1. ICD physical characteristicsa
Volume 39 cc
Mass 76 g
b
H x W x D
Surface area of device can 67 cm
Radiopaque IDc
Materials in contact with
human tissue
d
68 mm x 51 mm x 15 mm
2
PRM
Titanium / polyurethane / silicone rubber
BatteryLithium silver vanadium oxide
Connectors Two IS-1 connectors for pacing and
sensing, Two DF-1 connectors for high
voltage therapy, Active Can electrode
(programmable)
Device Port Connector
Typ e
Software
Name
SVCDF-1HVX
A
V
SVC
RV
RVDF-1HVB
Cann/aHVA, Can
VIS-1 bipolar
AIS-1 bipolar
Can
74lead.eps
Suture holes
78Suture.eps
a
Measurements are nominal values based on CAD (computer aided design)
model measurements and are rounded to the nearest unit.
b
Grommets may protrude slightly beyond the can surface.
c
Engineering series number follows the radiopaque code.
d
These materials have been successfully tested for the ability to avoid biological
incompatibility. The device does not produce an injurious temperature in the
surrounding tissue.
Maximo DR 7278 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.
Table 1-2. Effects of magnet application on the device
Pacing modeas programmed
Pacing rate and intervalas 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
The Test tone does not sound if “VF Detection/Therapy Off” is the only alert
enabled.
Quick reference
Magnet application
a
b
with programmable alert(s) 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)
c
19
Longevity projections
Longevity estimates are based on accelerated battery discharge
data and device modeling with EGM pre-storage off, 60 ppm
-1
(min
) pacing rate, with:
■
2.5 V pacing pulse amplitude, 0.4 ms pacing pulse width, and
35 J delivered therapy energy (see Table 1-3)
■
3 V pacing pulse amplitude, 0.4 ms pacing pulse width, and
35 J delivered therapy energy (see Table 1-4)
■
This model assumes default automatic capacitor formation
setting. As a guideline, each full energy charge decreases
device longevity by approximately 31 days.
Maximo DR 7278 Reference Manual
20
Chapter 1
Longevity projections
Table 1-3. Projected longevity in years with 2.5 V pacing amplitude and
0.4 ms pulse width
a
EGM
pre-storage
500 ohm
b
pacing
impedance
900 ohm
pacing
impedance
Percent
pacing
Maximum
energy
charging
frequency
DDDVVIDDDVVI
0%Semi-AnnualOff8.58.58.58.5
On8.38.38.38.3
QuarterlyOff7.17.17.17.1
On7.07.07.07.0
15%Semi-AnnualOff8.18.48.38.5
On7.98.28.18.3
QuarterlyOff6.97.17.07.1
On6.76.96.87.0
50%Semi-AnnualOff7.48.07.98.3
On7.27.87.78.1
QuarterlyOff6.46.86.77.0
On6.26.66.56.8
100%Semi-AnnualOff6.67.57.38.0
On6.47.37.27.8
QuarterlyOff5.76.46.36.8
On5.66.36.26.6
a
Maximum energy charging frequency may include full energy therapy shocks or
capacitor formations.
b
The data provided for programming EGM pre-storage on is based on a 6 month
period (two 3-month follow-up intervals) over the life of the device. Additional
use of EGM pre-storage reduces longevity by approximately 27% or 3 months
per year.
Maximo DR 7278 Reference Manual
Quick reference
Longevity projections
Table 1-4. Projected longevity in years with 3 V pacing amplitude and
0.4 ms pulse width
Percent
pacing
0%Semi-AnnualOff8.58.58.58.5
15%Semi-AnnualOff8.08.38.28.4
50%Semi-AnnualOff7.17.87.68.1
100%Semi-AnnualOff6.17.26.97.8
a
Maximum energy charging frequency may include full energy therapy shocks or
capacitor formations.
b
The data provided for programming EGM pre-storage on is based on a 6 month
period (two 3-month follow-up intervals) over the life of the device. Additional
use of EGM pre-storage reduces longevity by approximately 27% or 3 months
per year.
Maximum
energy
charging
frequency
a
EGM
pre-storage
500 ohm
b
pacing
impedance
900 ohm
pacing
impedance
DDDVVIDDDVVI
On8.38.38.38.3
QuarterlyOff7.17.17.17.1
On7.07.07.07.0
On7.88.18.08.2
QuarterlyOff6.87.06.97.1
On6.66.96.86.9
On6.97.67.47.9
QuarterlyOff6.16.76.56.9
On6.06.56.46.7
On5.97.06.87.6
QuarterlyOff5.46.26.06.6
On5.26.05.96.5
21
Maximo DR 7278 Reference Manual
22
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: 100% DDD pacing at 60 ppm, 3 V, 0.4 ms;
500 Ω pacing load; and six 35 J charges. EOL may be indicated
before the end of three months if the device exceeds these
conditions.
Maximo DR 7278 Reference Manual
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 b l e 1 - 6 . Ty p ic a la full energy charge times
At Beginning of Life (BOL)7.0 seconds
At Elective Replacement (ERI)8.9 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
23
Maximo DR 7278 Reference Manual
24
Chapter 1
High voltage therapy energy
Table 1-7. Comparing delivereda (programmed) and storedb energy levels
Energy (J)Charge
Delivered a/
Stored
b
Programmed
35397.010122.0
32376.4910.51.8
30346.089.31.6
28325.678.21.4
26305.267.11.2
25295.055.91.0
24274.844.80.8
22254.433.60.6
20234.022.40.4
18213.61.82.20.4
16193.21.62.00.3
15173.01.41.70.3
14162.81.21.50.2
13152.61.01.20.2
12142.40.81.00.2
11132.20.60.80.1
a
Energy delivered at connector block into a 75 ohm load.
b
Energy stored at end of charge on capacitor.
c
Typical charge time at Beginning of Life (BOL) with fully formed capacitors, rounded to the nearest tenth of
a second.
EGM optionsStore before onset; Store during charging
Flashback memory 2000 intervals (containing both A-A and V-V):
before latest VF, before latest VT, and before
interrogation
Counter data
Detection countersLifetime total, since cleared, and since last
session
Episode countersEpisodes:
■
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
Maximo DR 7278 Reference Manual
26
Chapter 1
Stored data and diagnostics
Table 1-8. Stored data and diagnostics (continued)
Therapy efficacy
counters
Other stored data
Counts for each VF, FVT, VT Therapy:
■
Delivered
■
Successful
■
Unsuccessful
■
Intervention (manually aborted)
Total number of aborted shocks
Patient Alert eventsUp to 10 log entries: text and date for the first
time an alert is triggered between interrogations
Battery and lead
measurements
Battery voltage, last capacitor formation, last
charge, lead impedance, EGM amplitude
measurements, last high voltage therapy, and
sensing integrity counter
Lead performance
trends
14 days of daily measurements plus 80 weeks
of weekly minimum and maximum
measurements:
■
Lead impedance: atrial pacing, ventricular
pacing, defibrillation pathway, and SVC
lead (if used)
The following features are new or changed from the
7275 GEM III DR ICD.
Patient management
RapidRead telemetry – Communication between the device and
programmer is approximately 20 times faster than telemetry in
previous Medtronic ICD devices. The magnitude of improvement
depends on the amount and type of data that is interrogated.
RapidRead telemetry is more reliable and has an increased range
that makes placing the programming head easier.
Cardiac Compass trends report – This report displays up to
14 months of trend data related to tachyarrhythmia episodes,
heart rate, and patient activity. See “Using Cardiac Compass to
view long term clinical trends” on page 298.
Patient Alert – The alert duration when a magnet is applied to the
device is now 20 seconds. The device also provides several
new alerts:
■
SVC (HVX) lead impedance out of range
■
Active Can off without SVC
■
DOO/VOO mode programmed
■
VF Detection programmed off, or fewer than four VF therapies
enabled for at least six hours
■
charge circuit timeout occurred
■
excessive charge time ERI
Quick reference
New and enhanced features
27
For more information, see “Using the Patient Alert feature” on
page 259.
EGM amplitude trends – The device automatically measures
R-wave and P-wave EGM amplitudes every day. These daily
measurements are included in the data displayed on the Lead
Performance Trends screen. See “Setting up data collection” on
page 273.
Maximo DR 7278 Reference Manual
28
Chapter 1
New and enhanced features
EGM amplitude test – You can use the EGM Amplitude test to
measure R-wave and P-wave EGM amplitudes. The results are
reported on the EGM Amplitude Test screen. See “Measuring
EGM Amplitude” on page 322.
Lead impedance measurement for SVC (HVX) – Along with
other lead impedance measurements, the device provides an
independent SVC (HVX) measurement to check the integrity of
the supplementary high voltage electrode. See “Measuring lead
impedance” on page 320.
Leadless ECG signal – If a supplementary high voltage
electrode is placed in the SVC, the device provides the
Leadless ECG signal through either the Can to SVC (HVX) or RV
(HVB) to SVC (HVX) EGM source. See “Setting up data collection”
on page 273.
Expanded pre-onset EGM storage – The device can now store
up to 20 seconds of EGM before a tachycardia starts. See “Setting
up data collection” on page 273.
Smart Auto Cap Formation – When the Auto Cap Formation
Interval is set to Auto, the formation interval automatically adjusts
to optimize device longevity and charge times. See “Smart Auto
Cap” on page 216.
Ending a patient session – The device audits the programmed
parameter settings when you end a patient session and alerts you
if any of the settings are atypical. See “Starting and ending patient
sessions” on page 234.
Tachyarrhythmia detection
VT Monitoring – VT detection can be set to Monitor, which allows
the device to detect and record VT episodes without delivering
therapy or influencing VF detection. See “VT monitoring” on
page 86.
High Rate Timeout – High Rate Timeout can turn off detection
enhancements (Stability, PR Logic criteria) if a high rate episode
is longer than a programmed duration. See “Details about High
Rate Timeout” on page 113.
Maximo DR 7278 Reference Manual
Tachyarrhythmia therapy
Episode confirmation during and after charging – The device
continually monitors the ventricular rhythm during and after
charging for cardioversion or defibrillation (when VF confirmation
is active) to ensure the arrhythmia is present before delivering the
high voltage shock. See “Confirming VF after initial detection” on
page 126 and “Confirming VT or FVT after detection” on
page 144.
Programmable Active Can – If a supplementary electrode is
connected to the SVC (HVX) port, you can deselect the device
Can as a high voltage electrode. See “Delivery pathway
electrodes” on page 123.
Output – The device has a maximum delivered energy of
35 joules.
Bradycardia pacing
Quick reference
New and enhanced features
29
EP studies
Accelerometer-based rate response – The device uses an
accelerometer to provide rate responsive pacing.
Additional bradycardia pacing modes – The device provides
asynchronous pacing in the DOO and VOO pacing modes and
provides the ODO mode to disable pacing. See Chapter 8,
“Treating bradycardia” on page 157.
Enhanced AT-style Mode Switch – Mode Switch episodes are
detected using a combination of the median atrial rate and the AF
evidence criterion. See “Details about Mode Switch” on page 192.
Defibrillation threshold testing support – The T-Shock and
50 Hz Burst induction screens allow you to monitor time between
inductions, program ventricular sensing and VF therapy settings,
adjust induction settings, select manual therapies, and retrieve
episode records after therapy. See “How to perform defibrillation
threshold testing” on page 57.
Maximo DR 7278 Reference Manual
30
Chapter 1
New and enhanced features
Backup VVI pacing during atrial inductions – You can choose
to have the device deliver backup ventricular pacing during Manual
Burst and PES inductions that are delivered to the atrium. See “EP
Study overview” on page 328.
Maximo DR 7278 Reference Manual
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