Medtronic 7304 Reference Guide
INSYNC MAXIMO
Dual chamber implantable cardioverter defibrillator with
cardiac resynchronization therapy including sequential
biventricular pacing
™
7304
Reference Manual
Caution: Federal Law (USA) restricts this device to sale
by or on the order of a physician (or properly licensed
practitioner).
INSYNC MAXIMO
™
7304
Reference Manual
A guide to the operation and programming of the Model 7304
InSync Maximo dual chamber implantable cardioverter defibrillator
with cardiac resynchronization therapy
The following are trademarks of Medtronic:
Active Can, Cardiac Compass, Checklist, Decision Channel, Flashback, InSync,
InSync II Marquis, InSync Sentry, InSync Maximo, Leadless, Marker Channel,
Marquis, Maximo, Medtronic, Medtronic CareLink, PR Logic, Patient Alert,
Quick Look, QuickLink, T-Shock
Contents
Introduction 11
Part I Quick overview 13
1 Quick reference 15
1.1 Physical characteristics 16
1.2 Magnet application 18
1.3 Projected longevity 18
1.4 Replacement indicators 20
1.5 Typical charge times 21
1.6 High-voltage therapy energy 21
1.7 Stored data and diagnostics 22
1.8 New and enhanced features 24
2 The InSync Maximo system 25
2.1 System overview 26
2.2 Indications and usage 29
2.3 Contraindications 30
2.4 Patient screening 30
3 Emergency therapy 31
3.1 Delivering emergency therapies 32
3.2 Delivering an emergency defibrillation therapy 33
3.3 Delivering an emergency cardioversion therapy 34
3.4 Delivering emergency fixed burst pacing 34
3.5 Enabling emergency VVI pacing 35
Part II Device implant and patient follow-up
procedures 37
4 Implanting the device 39
4.1 Overview 40
4.2 Preparing for an implant 40
4.3 Replacing a device 42
4.4 Surgical approach 43
INSYNC MAXIMO™7304 Reference Manual
6
Contents
4.5 Sensing and pacing measurements 47
4.6 Connecting the leads to the device 47
4.7 Testing defibrillation operation and effectiveness 51
4.8 Positioning and securing the device 54
4.9 Completing the implant procedure 54
5 Conducting a patient follow-up session 57
5.1 Patient follow-up guidelines 58
5.2 Verifying the status of the implanted system 59
5.3 Verifying effective cardiac resynchronization
therapy 59
5.4 Verifying effective basic pacing 60
5.5 Verifying accurate detection and appropriate therapy for
ventricular tachyarrhythmias 62
Part III Configuring the device for the patient 65
6 Detecting tachyarrhythmias 67
6.1 Detection overview 68
6.2 Setting up sensing 71
6.3 Detecting VF episodes 76
6.4 Detecting VT episodes 79
6.5 Detecting FVT episodes 85
6.6 Detecting tachyarrhythmia episodes with Combined
Count 90
6.7 Monitoring episodes for termination or
redetection 92
6.8 Enhancing detection with PR Logic criteria 96
6.9 Enhancing VT detection with the Stability
criterion 104
6.10 Detecting double tachycardias 106
6.11 Detecting prolonged tachyarrhythmias with High Rate
Timeout 107
7 Treating tachyarrhythmia episodes 111
7.1 Treating VF with defibrillation 112
7.2 Treating VT and FVT with antitachycardia
pacing 121
7.3 Treating VT and FVT with cardioversion 131
INSYNC MAXIMO™7304 Reference Manual
Contents
7.4 Optimizing therapy with Smart Mode and Progressive
Episode Therapies 139
8 Treating ventricular dysynchrony and
bradycardia 145
8.1 Providing basic pacing therapy 146
8.2 Dual chamber pacing 154
8.3 Single chamber pacing 165
8.4 Promoting continuous CRT delivery 169
8.5 Rate adjustments to optimize cardiac output 179
8.6 Managing atrial tracking to optimize A-V
synchrony 191
8.7 Providing Ventricular Safety Pacing 204
9 Optimizing charge time and device longevity 209
9.1 Optimizing charge time 210
9.2 Optimizing device longevity 212
Part IV Evaluating and managing patient treatment 215
10 Using the programmer 217
10.1 Setting up and using the programmer 218
10.2 Display screen features 219
10.3 Viewing and programming device parameters 224
10.4 Starting and ending patient sessions 229
10.5 Viewing live waveform traces 231
10.6 Recording live waveform strips 238
10.7 Saving and retrieving device data 240
10.8 Printing reports 244
11 Using system evaluation tools 251
11.1 A summary of system evaluation tools 252
11.2 Taking a quick look at device activity 253
11.3 Using the Patient Alert feature 254
11.4 Streamlining follow-ups with Checklist 262
12 Setting up and viewing collected data 267
12.1 A summary of data collection 268
12.2 Viewing battery and lead status data 269
12.3 Printing rate histograms 274
7
INSYNC MAXIMO™7304 Reference Manual
8
Contents
12.4 Viewing the Heart Failure Management report 278
12.5 Viewing clinical trends in the Cardiac Compass
report 282
12.6 Viewing the episode and therapy efficacy
counters 288
12.7 Viewing episode data 291
12.8 Viewing Flashback Memory 301
12.9 Setting up data collection 302
12.10 Viewing and entering patient information 308
12.11 Automatic device status monitoring 311
13 Testing the system 315
13.1 Testing overview 316
13.2 Evaluating the underlying rhythm 316
13.3 Measuring pacing thresholds 317
13.4 Measuring lead impedance 320
13.5 Measuring EGM amplitude 322
13.6 Testing the device capacitors 324
14 Conducting Electrophysiologic Studies 327
14.1 EP Study overview 328
14.2 Inducing VF with T-Shock 329
14.3 Inducing VF with 50 Hz Burst 333
14.4 Inducing an arrhythmia with Manual Burst 335
14.5 Inducing an arrhythmia with PES 338
14.6 Delivering a manual therapy 340
15 Solving system problems 345
15.1 Overview 346
15.2 Solving cardiac resynchronization therapy
problems 346
15.3 Solving sensing problems 347
15.4 Solving tachyarrhythmia detection problems 349
15.5 Solving tachyarrhythmia therapy problems 350
15.6 Solving bradycardia pacing problems 351
15.7 Responding to device status indicators 352
INSYNC MAXIMO™7304 Reference Manual
Appendices 355
A Warnings and precautions 357
A.1 General warnings 358
A.2 Handling and storage instructions 358
A.3 Resterilization 359
A.4 Device operation 360
A.5 Lead evaluation and lead connection 361
A.6 Follow-up testing 363
A.7 Explant and disposal 363
A.8 Medical therapy hazards 364
A.9 Home and occupational environments 366
B Device parameters 369
B.1 Emergency settings 370
B.2 Detection parameters 371
B.3 Therapy parameters 372
B.4 Pacing parameters 375
B.5 System maintenance parameters 378
B.6 Data collection parameters 380
B.7 System test and EP study parameters 381
B.8 Fixed parameters 384
B.9 Patient information parameters 385
B.10 Programmer symbols 386
B.11 Parameter interlocks 388
C Device programming recommendations 389
C.1 Device programming recommendations 390
C.2 V-V Delay programming recommendations 392
Contents
9
Glossary 397
Index 407
INSYNC MAXIMO™7304 Reference Manual
Introduction
Using this manual
Before implanting the device, it is strongly recommended that you:
Manual conventions
Throughout this document, the word “device” refers to the
implanted InSync Maximo device.
Introduction
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.
11
Technical support
The
nominal value for that parameter.
On-screen buttons are shown with the name of the button
surrounded by brackets: [Button Name].
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.
symbol in parameter tables indicates the Medtronic
INSYNC MAXIMO™7304 Reference Manual
12
Introduction
References
Notice
The primary reference for background information is Zacouto FI,
Guize LJ. Fundamentals of Orthorhythmic Pacing. In: Luderitz B,
Cardiac Pacing Diagnostic and Therapeutic Tools.
ed.
Springer-Verlag; 1976: 212-218.
See these additional references for more background information:
Estes M, Manolis AS, Wang P, Eds.
•
Cardioverter-Defibrillators
Inc. 1994.
Kroll MW, Lehmann MH, Eds.
•
Cardioverter-Defibrillator Therapy: The Engineering-Clinical
Interface
Singer I, Ed.
•
NY: Futura Publishing Co. 1994.
Singer I, Barold SS, Camm AJ, Eds.
•
Therapy of Arrhythmias for the 21st Century: The State of
the Art
. Norwell, MA: Kluwer Academic Publishers 1996.
Implantable Cardioverter-Defibrillator
. Armonk, NY: Futura Publishing Co. 1998.
. New York, NY: Marcel Dekker,
Implantable
Implantable
Nonpharmacological
New York:
. Armonk,
This software is provided as an informational tool for the end
user. The user is responsible for accurate input of patient
information into the software. Medtronic makes no representation
as to the accuracy or completeness of the data input into the
software. Medtronic SHALL NOT BE LIABLE FOR ANY DIRECT,
INDIRECT, INCIDENTAL OR CONSEQUENTIAL DAMAGES TO
ANY THIRD PARTY WHICH RESULTS FROM THE USE OF THE
INFORMATION PROVIDED IN THE SOFTWARE.
INSYNC MAXIMO™7304 Reference Manual
Quick overview
Part I
1Quick reference
1.1 Physical characteristics 16
1.2 Magnet application 18
1.3 Projected longevity 18
1.4 Replacement indicators 20
1.5 Typical charge times 21
1.6 High-voltage therapy energy 21
1.7 Stored data and diagnostics 22
1.8 New and enhanced features 24
1
16
Chapter 1
Physical characteristics
1.1 Physical characteristics
Table 1-1. Device physical characteristics
Volume
Mass
H x W x D
c
Surface area of device
40 cm
78 g
73 mm x 51 mm x 15 mm
67 cm
a
3 b
2
can
Radiopaque ID
Materials in contact with
human tissue
d
e
PRL
Titanium / polyurethane /silicone rubber
/ silicone adhesive
Battery Lithium silver vanadium oxide
Connectors Two IS-1 connectors for pacing and
sensing, one IS-1 connector for
pacing, two DF-1 connectors for
high-voltage therapy, Active Can
electrode (programmable)
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.
Table 1-2. Lead connections
Device port Connector type Software name
SVC (HVX) DF-1 SVC
RV (HVB) DF-1 RVcoil
Can
RV IS-1 bipolar RVtip and RVring
INSYNC MAXIMO™7304 Reference Manual
—
Can
1Quick reference
2
5
4
6
3
1
Physical characteristics
Table 1-2. Lead connections (continued)
Device port Connector type Software name
LV IS-1 bipolar LVtip and LVring
A IS-1 bipolar Atip and Aring
Figure 1-1. Lead connections
1 SVC (HVX)
2 RV (HVB)
3 Can (HVA)
4 LV
5 RV
6 A
17
Figure 1-2. Suture holes
INSYNC MAXIMO™7304 Reference Manual
18
Chapter 1
Magnet application
1.2 Magnet application
Bringing a magnet close to the device triggers changes in device
operation as shown in Table 1-3. When the magnet is removed,
the device returns to its programmed operations.
For information on demonstrating Patient Alert tones to the
patient, see Section 11.3.4, “Instructing the patient”, page 260.
Table 1-3. Effects of magnet application on the device
Pacing mode as programmed
Pacing rate and interval as programmed
VF, VT, and FVT detection suspended
Patient Alert audible tones
(20 s or less)
a
b
c
a
b
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)
•
Rate response adjustments are suspended while a Patient Alert tone sounds.
Detection resumes if telemetry is established and the application software is
running, or detection resumes after the application software has started.
Or “VF Detection/Therapy Off” is the only alert enabled.
c
1.3 Projected longevity
Longevity estimates are based on accelerated battery discharge
data and device modeling with EGM pre-storage off (see
Table 1-4).
INSYNC MAXIMO™7304 Reference Manual
1Quick reference
Projected longevity
Table 1-4. Projected longevity in years with pacing outputs programmed
to the specified amplitude and 0.4 ms pulse width, DDD mode, 100%
biventricular pacing, specified percentage of atrial pacing at 60 ppm
with the remainder at 70 bpm atrial tracking, semi-annual full-energy
charges.
Amplitudes:
A/RV; LV
2.5 V; 3.0 V
3.0 V; 4.0 V
a
a
% atrial
pacing
0% 5.8 6.2 6.5
25% 5.6 6.1 6.4
50%
100% 5.2 5.8 6.1
0% 5.0
25% 4.8 5.3
50% 4.6 5.2 5.6
100% 4.4 5.0 5.4
Semi-annual full-energy charges may include therapy shocks or capacitor
formations. Additional full-energy charges due to therapy shocks, device testing,
or capacitor formation reduces device longevity by approximately 23 days (0.06
years). Additional 30 J charges due to therapy shocks or device testing reduces
device longevity by approximately 21 days (0.06 years).
500 Ù
pacing
impedance
5.5
700 Ù
pacing
impedance
6.0 6.3
5.5
900 Ù
pacing
impedance
5.8
5.7
19
The longevity of the ICD 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
•
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 s of information before the onset of the tachyarrhythmia,
including:
AA and VV intervals
•
Marker Channel
•
Interval Plot Flashback
•
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20
Chapter 1
Replacement indicators
When the EGM pre-storage feature is programmed On, the
device also collects up to 20 s 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.
1.4 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 Quick Look and Battery and Lead Measurements
screens display the date when the battery reached ERI.
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 that 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.
INSYNC MAXIMO™7304 Reference Manual
Post-ERI conditions – EOL device status is defined as 3 months
following an ERI indication assuming the following post-ERI
conditions: 0% DDD atrial pacing, 100% DDD RV and LV pacing
at 60 ppm, 3 V atrial and RV pacing amplitude, 4 V LV pacing
amplitude, 0.4 ms pulse width; 500 Ù pacing load; and six 35 J
charges. EOL may be indicated before the end of 3 months if the
device exceeds these conditions.
1.5 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).
Table 1-6. Typicalafull-energy charge times
At Beginning of Life (BOL)
At Elective Replacement (ERI)
a
These charge times are typical when the capacitors are fully formed.
7.1 s
9.0 s
1Quick reference
Typical charge times
21
1.6 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.
Table 1-7. Comparison of delivered (programmed) and stored energy levels
Energy ( J)
Delivereda/
Programmed Stored
35 39 7.1
32 37 6.5
30 34 6.1
28 32
26 30 5.2
25 29 5.0
24 27 4.8
22 25 4.4
b
Charge
Timec( s)
5.7
Delivereda/
Programmed Stored
Energy ( J)
10 12 2.0
9 10.5 1.8
8 9.3 1.6
7
6 7.1 1.2
5
4 4.8 0.8
3 3.6 0.6
INSYNC MAXIMO™7304 Reference Manual
8.2 1.4
5.9 1.0
b
Charge
Timec( s)
22
Chapter 1
Stored data and diagnostics
Table 1-7. Comparison of delivered (programmed) and stored energy levels (continued)
Energy ( J)
Delivereda/
Programmed Stored
20 23 4.0
18 21 3.6
16 19 3.2
15 17 3.0
14 16 2.8
13 15 2.6
12 14 2.4
11 13 2.2
b
Charge
Timec( s)
Delivereda/
Programmed Stored
Energy ( J)
Charge
b
Timec( s)
2 2.4 0.4
1.8 2.2 0.4
1.6 2.0 0.3
1.4 1.7 0.3
1.2 1.5 0.2
1.0 1.2 0.2
0.8 1.0 0.2
0.6 0.8 0.1
0.4 0.5 0.1
a
Energy delivered at connector block into a 75 Ù 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.
1.7 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 14 min of dual-channel EGM or 23.5 min of single-channel
SVT/NST episodes 50 SVT/NST episodes: intervals, text, EGM (the device
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 (containing both A-A and V-V): before latest
Mode switch episodes 53 mode switch episodes (fastest, longest, first and 50
EGM
does not usually store detailed episode records for NST
episodes)
2 min of dual-channel EGM or 3.6 min of single-channel
EGM
VF, before latest VT, and before interrogation
latest): episode text
INSYNC MAXIMO™7304 Reference Manual
Table 1-8. Stored data and diagnostics (continued)
1Quick reference
Stored data and diagnostics
23
Ventricular sensing episodes 9 ventricular sensing episodes (longest, first, and 7 latest):
Counter data
Detection counters Lifetime total, since cleared, and since last session
Episode counters Episodes:
Therapy efficacy counters Counts for each VF, FVT, VT Therapy:
Other stored data
Patient Alert — System events Up to 10 log entries: text and date for the first time an alert
Battery and lead measurements Battery voltage, last capacitor formation, last charge,
Lead performance trends 14 days of daily measurements plus 80 weeks of weekly
intervals, markers, and counter data text
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
•
Delivered
•
Successful
•
Unsuccessful
•
Intervention (manually aborted)
•
Total number of aborted shocks
is triggered between interrogations
lead impedance, EGM amplitude measurements, last
high-voltage therapy, and sensing integrity counter
minimum and maximum measurements:
Lead impedance: atrial pacing, RV pacing, LV pacing,
•
defibrillation pathway, and SVC lead (if used)
atrial EGM amplitude: (P-waves)
•
INSYNC MAXIMO™7304 Reference Manual
24
Chapter 1
New and enhanced features
Table 1-8. Stored data and diagnostics (continued)
Rate Histograms
Cardiac Compass trends 14 months of daily measurements:
Atrial rate
•
Ventricular rate
•
Ventricular rate during AT/AF
•
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
•
1.8 New and enhanced features
The following features are new or changed from the 7289 InSync
II Marquis ICD.
1.8.1 Tachyarrhythmia therapy
Output – The InSync Maximo has a maximum delivered energy
of 35 J.
1.8.2 Cardiac resynchronization therapy
Sequential biventricular pacing – The ventricular sequence
and V-V pace delay are programmable to support improved
hemodynamics.
Pacing outputs for RV and LV are independently programmable.
INSYNC MAXIMO™7304 Reference Manual
2The InSync Maximo system
2.1 System overview 26
2.2 Indications and usage 29
2.3 Contraindications 30
2.4 Patient screening 30
2
26
Chapter 2
System overview
2.1 System overview
The Model 7304 InSync Maximo dual chamber implantable
cardioverter defibrillator with cardiac resynchronization therapy
(CRT ICD), including sequential biventricular pacing, is an
implantable medical device system that includes 3 major
components:
CRT ICD device
•
leads
•
programmer, software, and accessories
•
Each is described in detail below.
Device – The device senses the electrical activity of the patient’s
heart using the sensing electrodes of the implanted atrial and
right ventricular leads. It then analyzes the heart rhythm based
on selectable sensing and detection parameters. The device
provides the following functions:
simultaneous or sequential biventricular pacing for cardiac
•
resynchronization
automatic detection and treatment of ventricular
•
tachyarrhythmias (ventricular fibrillation, ventricular
tachycardia, and fast ventricular tachycardia) with
defibrillation, cardioversion, and antitachycardia pacing
therapies
single or dual chamber pacing for patients requiring rate
•
support
diagnostics and monitors that evaluate the system and
•
assist in patient care
Leads – The device can be used with transvenous or epicardial
defibrillation leads. The lead system should consist of bipolar
or paired unipolar pacing/sensing leads in the right atrium and
right ventricle of the heart, a pacing lead for the left ventricle,
and 1 or 2 high-voltage cardioversion/defibrillation electrodes. In
addition to the lead system, the Active Can acts as one of the
high-voltage electrodes. The device delivers pacing and cardiac
resynchronization therapy via the atrial (A), right ventricular (RV),
and left ventricular (LV) leads. The device senses using the atrial
and RV leads. Cardioversion/defibrillation therapy is delivered
with 2 lead-based high-voltage electrodes, or with the Active Can
and 1 or 2 lead-based high-voltage electrodes.
INSYNC MAXIMO™7304 Reference Manual
2The InSync Maximo system
System overview
Programmer and software – The Medtronic CareLink
Programmer, Model 2090,1and Model 9998 software application
allow you to perform the following functions:
configure the cardiac resynchronization, arrhythmia detection
•
and therapy, and bradycardia features for your patient
perform electrophysiological studies and system tests
•
monitor, display, or print patient cardiac activity information
•
For information about:
indications, contraindications, warnings and precautions,
•
see the implant manual that accompanies the device.
basic programmer and software desktop functions
•
that are not included in Chapter 10, “Using the
programmer”, page 217, see the manual accompanying
the programmer.
installing the Model 2067 or Model 2067L programming
•
head, see the manuals accompanying the programming
heads.
implanting leads and using implant tools, refer to the
•
manuals accompanying the leads and implant tools.
27
2.1.1 Cardiac resynchronization
To improve cardiac output in patients with ventricular dysynchrony,
the device provides biventricular pacing. The device paces either
the right ventricle or both ventricles as programmed, unless
pacing is inhibited by a sensed event in the RV.
Ventricular pacing sequence, V-V pace delay and LV pacing
•
vector are programmable.
Optional CRT features promote sustained resynchronization
•
pacing that could be interrupted during episodes of
accelerated AV conduction, atrial rate excursions, PVCs, or
atrial arrhythmia.
Pacing amplitudes and pulse widths are selected
•
independently for each ventricle.
1
With the model 2067 programming head
INSYNC MAXIMO™7304 Reference Manual
28
Chapter 2
System overview
2.1.2 Detecting and treating tachyarrhythmias
The device monitors the cardiac rhythm for short ventricular
intervals that may indicate the presence of VF, VT, or FVT.
Upon detection of VF, the device delivers a biphasic
•
defibrillation shock of up to 35 J. If the VF episode persists,
up to 5 more individually programmed defibrillation shocks
can be delivered.
Upon detection of VT, the device delivers either a Ramp,
•
Ramp+, or Burst antitachycardia pacing therapy or a
biphasic cardioversion shock of up to 35 J synchronized to
a ventricular depolarization. If the VT episode persists, up
to 5 more individually programmed VT therapies can be
delivered. You can also program the device to monitor the
VT episode without delivering therapy.
Upon detection of FVT, the device delivers either a Ramp,
•
Ramp+, or Burst antitachycardia pacing therapy or a
biphasic cardioversion shock of up to 35 J synchronized to
a ventricular depolarization. If the FVT episode persists,
up to 5 more individually programmed FVT therapies can
be delivered.
You can program the device to distinguish between true
ventricular arrhythmias and rapidly conducted supraventricular
tachyarrhythmias (SVT) and withhold therapy for SVT.
SVT discrimination includes the capability to detect a double
tachycardia (an unrelated ventricular arrhythmia occurring
simultaneously with an SVT) so that therapy is not withheld for a
ventricular arrhythmia in the presence of an SVT.
2.1.3 Treating bradycardia
The device provides rate responsive pacing to optimize
hemodynamics. 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.
INSYNC MAXIMO™7304 Reference Manual
2.1.4 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 ventricular sensing episodes, 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 physical activity, heart rate, percent
pacing, arrhythmia episodes, and therapies delivered.
All of this information can be printed and retained in the patient’s
file or saved in electronic format on a floppy diskette.
2.1.5 Conducting electrophysiologic tests
You can use the system to conduct non-invasive electrophysiologic
studies, including manual delivery of any of the device therapies
to manage an induced or spontaneous tachyarrhythmia.
2.1.6 Alerting the patient to system events
2The InSync Maximo system
Indications and usage
29
You can use the programmable Patient Alert monitoring feature to
notify the patient with audible tones if certain conditions related to
the leads, battery, charge time, and therapies occur. The patient
can then respond based on your prescribed instructions.
2.2 Indications and usage
The InSync Maximo is indicated for ventricular antitachycardia
pacing and ventricular defibrillation for automated treatment of life
threatening ventricular arrhythmias. The system is also indicated
for the reduction of the symptoms of moderate to severe heart
failure (NYHA Functional Class III or IV) in those patients who
remain symptomatic despite stable, optimal medical therapy and
have a left ventricular ejection fraction ≤ 35% and a prolonged
QRS duration.
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Chapter 2
Contraindications
2.3 Contraindications
2.4 Patient screening
Do not use the InSync Maximo system in:
Patients whose ventricular tachyarrythmias may have
•
transient or reversible causes, such as:
– acute myocardial infarction
– digitalis intoxication
– drowning
– electric shock
– electrolyte imbalance
– hypoxia
– sepsis
Patients with incessant VT or VF
•
Patients who have a unipolar pacemaker.
•
Before implant, patients should undergo a complete cardiac
evaluation, including electrophysiologic testing. Also,
electrophysiologic evaluation and testing of the safety and efficacy
of the proposed tachyarrhythmia therapies are recommended
during and after device implant.
Other optional screening procedures could include exercise
stress testing to determine the patient’s maximum sinus rate,
and cardiac catheterization to determine if there is a need for
concomitant surgery and/or medical therapy.
INSYNC MAXIMO™7304 Reference Manual
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