Medtronic.Kappa® 400 Series
Pacemaker Information and
Programming Guide
Volume II - Pacemaker Reference
Guide
A Guide To
Understanding the
Medtronic.Kappa
DR
K
401, KDR403,
SR
K
401, KSR403,
Pacemakers
®
This guide also applies to
Medtronic DX2 7970 and 7972
pacemakers as described in
Section I at the back of this guide.
Caution: Federal law (USA)
restricts this device to sale by
or on the order of a physician.
4
Checklist, Fast Path, Kappa, Marker Channel, Medtronic, Medtronic.Kappa, Medtronic.Vision, Rate Profile Optimization, Remote
Assistant, Significant Events, Sinus Preference, Quick Look, and Vision are all trademarks of Medtronic, Inc.
Introduction to Diagnostics 17-2
Atrial and Ventricular Rate Histograms 17-8
AV Conduction Histogram 17-10
Sensor Indicated Rate Profile 17-13
Atrial and Ventricular High Rate Diagnostics 17-14
Remote Assistant
TM
Diagnostic 17-19
Custom Rate Trend 17-21
18. Troubleshooting the Pacing System
Troubleshooting Strategy 18-2
Troubleshooting Hemodynamic Problems 18-6
Handling, Storage, and Resterilization 18-8
Pacemaker Longevity 18-9
Replacing the Pacemaker 18-11
Patient Information and Service 18-12
Programmable Modes and Parameters E-2
Nonprogrammable Parameters E-8
Temporary Modes and Parameters E-9
Rate Response Programming Guidelines E-10
Programming Restrictions and Requirements E-12
Timing Reference E-15
F. Warnings and Precautions
Special Notice F-2
Warnings F-3
Precautions F-5
Potential Complications F-9
G. Environmental Interference
Hospital or Medical Environment Interference G-2
Home and Job Environment Interference G-7
H. Pacing Indications
Indications in Acquired Atrioventricular Block in Adults H-2
Indications After Myocardial Infarction H-4
Indications in Bifascicular and Trifascicular BlockH-5
Indications in Sinus Node Dysfunction H-6
Indications in Hypersensitive Carotid Sinus Syndrome and Neurovas-
cular Syndromes H-7
Indications in Children H-8
vi
9
Medtronic.Kappa® 400 Series Pacemaker Information and Programming Guide
I. Supplement: DX2 Models 7970 and 7972
How To Use This SupplementI-2
Pacemaker Differences I-3
Low MV Monitor I-5
Radiopaque Identification I-6
Pacemaker Connectors I-7
Longevity Projections I-8
Battery Specifications I-10
Lead Compatibility I-10
Mechanical Dimensions I-10
J. Glossary
K. Index
Table of Contents
10
Medtronic.Kappa® 400 Series Pacemaker Information and Programming Guide
vii
How To Use This Guide
Guide Is Organized Into Two Volume Set
Product information about Medtronic.Kappa® 400 Series
pacemakers and Vision software is organized into a two-volume
set:
■
Volume I, which contains programming information is
comprised of Chapters 1 through 9.
■
Volume II, which contains pacemaker information includes
Chapters 10 through 18 and Sections A through J.
Note that implant information is also provided in the product
information manual that is packaged with each Kappa pacemaker.
What Is Contained In This Guide - Volume II
How To Use This Guide
12
This guide describes how the pacemaker operates and specifies
the capabilities of each model.
■
Chapters 10 through 17 describe the pacing modes, rate
response options, special therapy features, telemetry types,
and data collection options. In some cases, guidelines are
given of how to configure these pacemaker operations.
■
Chapter 18 contains troubleshooting information for electrical
and hemodynamic problems.
■
Sections A through E specify parameter and data collection
capabilities, longevity projections, and mechanical and
electrical specifications.
■
Sections F through H provide general warnings and cautions,
potential interference with the pacemaker, and general
indications for pacing. A supplement covering the clinical
DX2 pacemakers, a glossary, and an index follow section H.
Medtronic.Kappa® 400 Series Pacemaker Information and Programming Guide
ix
How To Use This Guide
What Is Contained In The Programming
Guide - Volume I
Volume I instructs the clinician on the Model 9790/C Programmer
and managing Kappa pacemaker patients. Chapters 1 through 9
cover the following topics:
■
how to setup, configure, and operate the programmer and
accessing on-line help
■
using programmer features to conduct patient follow-up
sessions
■
viewing patient ECGs and electrocardiograms
■
retrieving pacemaker collected data and configuring new
data collection options
■
evaluating pacemaker parameter settings and programming
new settings, if necessary
■
initializing the minute ventilation sensor and verifying rate
response operation
13
x
Medtronic.Kappa® 400 Series Pacemaker Information and Programming Guide
Understanding
Pacemaker Operation
Chapters 10 - 18 provide detailed information about the
operation of the Kappa 400 series pacemakers.
Pacing Modes
Rate Response
Pacemaker Timing
16
Lead/Cardiac Tissue Interface
Special Therapy Options
Telemetry Data
Miscellaneous Operations
Diagnostics
Troubleshooting The
Pacing System
Pacing Modes
General Desciption
This chapter provides information about the modes
available with the pacemaker. The sections are as
follows:
10
Introduction
Mode Selection
Decision Tree:
Mode Pertinency Tables
Indications/Intended Use
Contraindications
DDDR Mode
DDD Mode
DDIR Mode
DDI Mode
DVIR Mode
DVI Mode
Medtronic.Kappa® 400 Series Pacemaker Information and Programming Guide
10-2
10-4
10-5
10-7
10-8
10-9
10-10
10-11
10-12
10-13
10-14
VDD Mode
AAIR / ADIR Modes
AAI / ADI Modes
VVIR / VDIR Modes
VVI / VDI Modes
AAT / VVT Modes
DOOR / AOOR / VOOR
Modes
DOO / AOO / VOO Modes
ODO / OAO / OVO Modes
10-15
10-16
10-17
10-18
10-19
10-20
10-21
10-22
10-23
10-1
18
Pacing Modes
Introduction
Introduction
Pacing Mode Selection
This chapter provides an introduction to pacemaker modes as an
aid to pacing mode selection. The chapter is organized as follows:
Mode Selection Decision Tree – This decision tree, based on the
■
1991 ACC/AHA guidelines for pacemaker implantation,
provides a simple means of identifying pacing modes
appropriate for given indications. More specific indications
for bradycardia-related pacing are described in Section H.
Mode Pertinency Tables – These tables show which features and
■
parameters apply to each commonly used pacing mode.
Mode Descriptions – These descriptions provide indications
■
and contraindications for modes available with the
pacemaker and brief descriptions of how these modes
operate.
1
19
10-2
1. Dreifus LS, Fisch C, Griffin JC, et al. Guidelines for implantation of cardiac
pacemakers and antiarrhythmia devices. A report of the American College of
Cardiology/American Heart Association Task Force on Assessment of
Diagnostic and Therapeutic Cardiovascular Procedures (Committee on
Pacemaker Implantation).
18: 1-13.
Journal of the American College of Cardiology.
Medtronic.Kappa® 400 Series Pacemaker Information and Programming Guide
1991;
Pacing Modes
Introduction
NBG Pacing Codes
The pacemaker modes are defined in NBG Code.1 Each five-letter
NBG code describes a specific type of operation for implantable
pacemakers. For simplicity, this manual uses only the first three or
four letters, such as DDD, DDIR, DVIR, and so forth. Figure 10-1
describes the first four letters of the NBG code.
CHAMBER PACED
V = Ventricle
A = Atrium
D = Dual Chamber
S = Single Chamber
O = None
CHAMBER SENSED
V = Ventricle
A = Atrium
D = Dual Chamber
S = Single Chamber
O = None
Figure 10-1.
DDDR
NBG Pacing Codes
MODE OF RESPONSE
T = Triggered
I = Inhibited
D = Double (Both)
O = None
PROGRAMMABLE/
RATE RESPONSE
P = Programmable
M = Multiprogrammable
C = Communicating
R = Rate Responsive
O = None
Further Information
The mode descriptions in this chapter provide only a basic
overview of each mode. For further details on the rate response,
timing, and therapy capabilities refer to Chapter 11, Chapter 12,
and Chapter 14, respectively.
20
1. Bernstein A., et al., “The NASPE/BPEG Pacemaker Code,” PACE, 10(4), Jul-Aug
1987. (“NBG” stands for “The North American Society of Pacing and
Electrophysiology [NASPE] and the British Pacing and Electrophysiology
Group [BPEG] Generic.” NBG’s five-letter code supersedes the ICHD Code.
Medtronic.Kappa® 400 Series Pacemaker Information and Programming Guide
10-3
Pacing Modes
Mode Selection Decision Tree:
Mode Selection Decision Tree:
Figure 10-2 shows a basic decision tree used to select the pacing mode. In the shaded boxes the
preferred mode(s) are listed and the alternate mode(s) appears below the dashed line.
Symptomatic
Bradycardia
(e.g., persistent
atrial fibrillation,
inexcitable atrium)
is SA node conduction
Ye sNoNoYes
AAI
DDD
AAIR
DDDR
No
VVIR
VVI
presently adequate?
Can the atrium be sensed
and/or paced reliably?
presently adequate?
AAIR
DDDR
Figure 10-2.
Ye s
is AV conduction
Mode Selection Tree
is SA node conduction
presently adequate?
DDD
DDDR
VDD
NoYe s
(e.g., complete or
transient AV block)
DDDR
DDIR
21
10-4
Medtronic.Kappa® 400 Series Pacemaker Information and Programming Guide
Pacing Modes
Mode Pertinency Tables
✓
*
–––
✓✓
–––
✓✓
––
✓
✓ ✓ ✓ ✓✓
✓✓✓✓ ✓
22
Mode Pertinency Tables
–
Pacing Parameters Available For Each Mode
Table 10-1.
Table 10-1 and Table 10-2 indicate which pacing parameters and features apply to each commonly used pacing mode
by black check marks. Dashes indicate parameters that are programmable but not pertinent to basic mode operation.
These parameters are programmable when mode switch, RAAV, or sensor-varied PVARP are active or when
background rate response is operative.
Basic Operation Parameters
✓ ✓✓✓✓✓✓✓✓✓✓✓✓✓✓✓
Pacing ParameterDDDR DDD DDIR DDI DVIR DVI VDD VVIR VDIR VVI VDI VVT AAIR ADIR AAI ADI AAT
Lower Rate
✓
–
✓✓✓
✓✓✓
Upper Tracking Rate
✓ ✓✓✓✓✓
✓
Sensed AV Interval
Paced AV Interval
Upper Sensor Rate
✓✓✓✓ ✓
✓ ✓✓✓✓
†
PVARP
Rate Adaptive AV
✓ ✓✓✓✓✓✓
PVAB
Atrial Blanking
Atrial Refractory Period
✓ ✓✓✓✓✓✓✓
✓ ✓✓✓✓✓✓✓✓✓✓✓
Ventricular Blanking (After AP)
Ventricular Refractory Period
* See Chapter 12 for operational descriptions of these timing parameters.
Medtronic.Kappa® 400 Series Pacemaker Information and Programming Guide
Standard pacing and sensing parameters (amplitude, pulse width, sensitivity, and pace/sense polarities) are
Note:
† Sensor-varied PVARP available in the DDDR, DDD, DDIR, and VDD modes.
not shown here but are found in Section E. Also, asynchronous modes are not shown.
10-5
Pacing Modes
Mode Pertinency Tables
*
Features Available For Each Mode
Special Therapy Options
✓✓✓✓✓ ✓
✓✓
†
Rate Response Therapy Options
–––
–––
–––
–––
✓✓
✓✓
✓✓
✓✓
–––
–––
–––
–––
✓✓
✓✓
✓✓
✓✓
––
––
––
––
✓
✓
✓
✓
–
–
–
–
✓
✓
✓
✓
–––
–––
✓✓
✓✓
–––
–––
✓✓
✓✓
––
––
✓
✓
–
–
✓
✓
23
Table 10-2.
10-6
✓✓
✓
✓✓✓
Fe atu reDDDR DDD DDIR DDI DVIR DVI VDD VVIR VDIR VVI VDI VVT AAIR ADIR AAI ADI AAT
Managing Atrial Rhythms
Mode Switch
Non-Competitive Atrial Pacing
✓✓✓
Rhythms
PMT Intervention
Managing Ventricular
✓ ✓✓✓✓✓
✓ ✓✓✓✓
Ventricular Safety Pacing
Special Pacing Operations
Rate Drop Response
PVC Response
Single Chamber Hysteresis
✓ ✓✓✓✓✓✓✓✓✓✓✓✓✓✓
Sinus Preference ✓Sleep Function
–
✓
✓
✓
Integrated Sensor
Rate Profile Optimization
ADL Rate
–
–
Medtronic.Kappa® 400 Series Pacemaker Information and Programming Guide
–
–
–
✓
✓
✓
Activity Threshold
Activity Sensor
Minute Ventilation Sensor
* See Chapter 14 for operational descriptions of special therapy options.
† See Chapter 11 for operational descriptions of rate response features.
Indications/Intended Use
Kappa pacemakers are indicated for the following:
Rate adaptive pacing in patients who may benefit from
■
increased pacing rates concurrent with increases in activity
and/or minute ventilation.
–Symptomatic paroxysmal or permanent second or third-
degree AV block.
–Symptomatic bilateral bundle branch block.
–Symptomatic paroxysmal or transient sinus node
dysfunctions with or without associated AV conduction
disorders.
–Bradycardia-tachycardia syndrome to prevent
symptomatic bradycardia or some forms of symptomatic
tachyarrhythmias.
Pacing Modes
Indications/Intended Use
24
–Vasovagal syndromes or hypersensitive carotid sinus
syndromes.
Kappa pacemakers are also indicated for dual chamber and atrial
tracking modes in patients who may benefit from maintenance of
AV synchrony. Dual chamber modes are specifically indicated for
treatment of conduction disorders that require restoration of both
rate and AV synchrony, which include:
Various degrees of AV block to maintain the atrial
■
contribution to cardiac output.
VVI intolerance (e.g., pacemaker syndrome) in the presence of
■
persistent sinus rhythm.
Medtronic.Kappa® 400 Series Pacemaker Information and Programming Guide
10-7
Pacing Modes
Contraindications
Contraindications
Kappa pacemakers are contraindicated for the following
applications:
Dual chamber atrial pacing in patients with chronic refractory
■
atrial tachyarrhythmias.
Asynchronous pacing in the presence (or likelihood) of
■
competitive paced and intrinsic rhythms.
Co-implant in a patient with an implanted cardioverter-
■
defibrillator (ICD) because it may cause unwanted delivery of
ICD therapy.
25
10-8
Medtronic.Kappa® 400 Series Pacemaker Information and Programming Guide
DDDR Mode
Pacing Modes
DDDR Mode
In the DDDR mode, the pacemaker tracks the faster of the intrinsic
atrial rate or the sensor-indicated rate. If the intrinsic rate is faster,
the DDDR mode provides atrial synchronous pacing; otherwise,
AV sequential pacing occurs at the sensor-indicated rate.
Rate limits for atrial tracking (Upper Tracking Rate)1 and
■
sensor tracking (Upper Sensor Rate) are separately
programmable.
The AV intervals that follow sensed atrial events (SAV) and
■
paced atrial events (PAV) are separately programmable, and
they can be programmed to shorten with increasing rates
(Rate Adaptive AV).
A nonrefractory sensed event in either chamber inhibits
■
pacing in that chamber. A ventricular nonrefractory sensed
event in the VA interval that is not preceded by an atrial sense
(AS or AR) may be a pacemaker-defined PVC, and starts a
new VA interval.
26
Sensor-indicated
Interval
A
P
V
P
Parameters:
Lower Rate = 60 ppm (1000 ms)PAV Interval = 200 msPVARP = 280 ms
Sensor-indicated Rate = 90 ppm (667 ms) SAV Interval = 170 ms
A
P
V
S
Figure 10-3.
Example of DDDR Mode Operation
Sensor-indicated
Interval
A
S
V
S
A
P
V
P
1. The Total Atrial Refractory Period (TARP) may limit the tracking rate to a lesser
value.
Medtronic.Kappa® 400 Series Pacemaker Information and Programming Guide
A
S
V
P
200 ms
10-9
Pacing Modes
DDD Mode
DDD Mode
The DDD mode provides atrial synchronous pacing in the
presence of intrinsic atrial activity; otherwise, AV sequential
pacing occurs at the Lower Rate.
Each atrial paced or nonrefractory atrial sensed event starts an
■
AV interval and a lower rate interval. The AV intervals that
follow sensed atrial events (SAV) and paced atrial events
(PAV) are separately programmable, and the SAV may be
optionally programmed to shorten with increasing rate (Rate
Adaptive AV).
Ventricular paced events may track atrial sensed events up to
■
the programmed Upper Tracking Rate.
A ventricular nonrefractory sensed event in the VA interval
■
1
that is not preceded by an atrial sense (AS or AR) may be a
pacemaker-defined PVC, and starts a new VA interval.
1. The Total Atrial Refractory Period (TARP) may limit the tracking rate to a lesser
value.
Lower Rate Interval
A
S
V
S
200 ms
Medtronic.Kappa® 400 Series Pacemaker Information and Programming Guide
A
P
27
DDIR Mode
Pacing Modes
DDIR Mode
The DDIR mode provides dual chamber, sensor-driven,
atrioventricular (AV) sequential pacing for heart rate variation
without atrial tracking.
Atrial pacing occurs at the sensor-indicated rate, with
■
ventricular pacing at the end of the PAV interval unless
inhibited.
An atrial event sensed outside the PVARP will inhibit a
■
scheduled atrial stimulus but will not start an AV interval.
That is, ventricular paced events after such sensed atrial
events occur at the sensor-indicated rate.
A ventricular nonrefractory sensed event in the
■
ventriculoatrial (VA) interval starts a new VA interval.
Medtronic.Kappa® 400 Series Pacemaker Information and Programming Guide
V
P
200 ms
31
VDD Mode
Pacing Modes
VDD Mode
The VDD mode provides atrial synchronous pacing (or VVI
pacing at the Lower Rate). The ventricle is paced synchronously
up to the programmed Upper Tracking Rate.
1
Sensing occurs in
both the atrium and ventricle, but pacing occurs only in the
ventricle.
To promote atrial synchronous pacing at slow rates, a sensed
■
atrial event occurring near the end of the lower rate interval
will be followed by the programmed maximum SAV interval.
The result is an extension of the ventricular lower rate.
A ventricular nonrefractory sensed event in the V-V interval
■
that is not preceded by an atrial sense (AS or AR) may be a
pacemaker-defined PVC, and it starts a new V-V interval.
1. The Total Atrial Refractory Period (TARP) may limit the tracking rate to a lesser
value.
Example of VDD Operation
A
S
V
P
Medtronic.Kappa® 400 Series Pacemaker Information and Programming Guide
A
S
200 ms
10-15
32
Pacing Modes
AAIR / ADIR Modes
AAIR / ADIR Modes
The AAIR mode provides atrial-based rate responsive pacing in
patients with intact AV conduction. Sensing and pacing occur
only in the atrium. In the absence of sensed events, the chamber is
paced at the sensor-indicated rate.
The ADIR mode operates the same as the AAIR mode except that
events sensed in the ventricle are recorded by the diagnostics.
When used in conjunction with Marker Channel telemetry and
concurrent ECG, this mode may be used to observe the conducted
ventricular rhythm without affecting atrial pacing.
In the AAIR and ADIR modes, atrial refractory sensed
Note:
events do not restart the upper sensor rate interval.