Medtronic KD901 Reference Guide

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Pacemaker Reference Guide
KAPPA®900/800
KDR900/920/930 Series KD900 Series KVDD900 Series KSR900 Series KDR800 Series
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Kappa® 900/800 Series Pacemaker Reference Guide
A guide to the Kappa 900/800 Series pacemakers: KDR900/920/930 Series
D900 Series
K KVDD900 Series KSR900 Series KDR800 Series
Refer to the Kappa® 900/800 Pacemaker Programming Guide for information on software and programming.
Caution: Federal law (USA) restricts this device to sale by or on the order of a physician.
®
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The following are trademarks of Medtronic.
Capture Management, Checklist, FAST, Fast Path, Implant Detection, Kappa, Key Parameter History, Marker Channel, Medtronic, Rate Profile Optimization, Remote Assistant, Auto-PVARP, Quick Look, Search AV, Sensing Assurance, Significant Events, Sinus Preference, and Vision.
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How to Use This Guide

Information is Contained in Two Guides

Product information about Kappa 900/800 Series pacemakers and the associated software for the 9790 series programmer is presented in two separate guides.
This guide, the Pacemaker Reference Guide (PRG), is a supplementary guide that provides detailed information on Kappa 900/800 Series pacemakers.
The Pacemaker Programming Guide (PPG) accompanies the programmer software for the Kappa 900/800 Series pacemakers and contains instructions on how to use the programmer with these pacemakers.

About this Guide

This supplementary guide describes in detail, how the pacemaker operates and specifies the capabilities of each model.
Describes the pacing modes, rate response options, special therapy features, telemetry types, and data collection options. In some cases, guidelines are given on how to configure the pacemaker operation.
Contains troubleshooting information for electrical and hemodynamic problems.
Specifies parameter and data collection capabilities, longevity projections, and mechanical and electrical specifications.
Provides general warnings and cautions, potential interference sources, and general indications for pacing.
Contains a glossary of terms.
How to Use This Guide
Kappa 900/800 Series Pacemaker Reference Guide iii
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How to Use This Guide

About the Pacemaker Programming Guide

This guide presents the following information to use the 9790 programmer.
How to setup and configure the programmer and access on-line help.
How to start a patient session, use the various follow-up features during the session, and properly end the session.
How to use checklist to streamline a follow-up session.
How to view and print the patient’s ECG and EGM waveform traces.
How to configure the pacemaker to collect diagnostic data and how to retrieve and view this information.
How to measure stimulation thresholds and sensing levels.
How to program parameter values and verify rate response parameters settings.
How to run EP Studies.
iv Kappa 900/800 Series Pacemaker Reference Guide
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Table of contents

Table of contents
How to Use This Guide iii
Information is Contained in Two Guides iii About this Guide iii About the Pacemaker Programming Guide iv
1. Pacing modes
Introduction 1-2
Pacing mode selection 1-2 NBG pacing codes 1-2
Further information 1-3 Mode selection decision tree 1-4 Mode pertinency tables 1-5 Indications and usage 1-7 Contraindications 1-7 DDDR mode 1-8 DDD mode 1-9 DDIR mode 1-10 DDI mode 1-11 DVIR mode 1-12 DVI mode 1-13 VDD mode 1-14 AAIR / ADIR modes 1-15 AAI / ADI modes 1-16 VVIR / VDIR modes 1-17 VVI / VDI modes 1-18 AAT / VVT modes 1-19 DOOR / AOOR / VOOR modes 1-20 DOO / AOO / VOO modes 1-21 ODO / OAO / OVO modes 1-22
2. Rate response
Introduction to rate responsive pacing 2-2
Rate response 2-2
Automatic features 2-2
For further information 2-3 Preset rate response at implant 2-3
Overview 2-3
Three pacing rate controls 2-3
Independent control of submaximal and maximal rates 2-4
Starting rate response immediately 2-4
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Table of contents
For further information 2-4
Rate Profile Optimization operation 2-5
Overview 2-5 Submaximal and maximal rate control 2-5 Optimization using rate profiles 2-6 Daily optimization of rate response 2-7 Adaptations in Optimization operation 2-8
Individualizing Rate Profile Optimization 2-9
Overview 2-9 Submaximal rate profiles 2-9 Maximal rate profiles 2-9 Programming guidelines 2-9
Activity sensor operation 2-11
Overview 2-11 How Activity Threshold influences rate 2-11 Evaluating the Activity Threshold setting 2-12 How Activity Acceleration and Deceleration influence rate 2-13 Exercise Deceleration operation 2-15
Manual control of Rate Profile Optimization 2-16
Overview 2-16 Evaluate and program rate response 2-16
3. Pacemaker timing
Rates 3-2
Overview 3-2 A-A and V-V timing 3-3 Lower Rate 3-3 Operating lower rate 3-4 Selecting a Lower Rate 3-4 Sensor-indicated rate 3-5 Sensor indicated rate effect on other intervals 3-6 ADL Rate 3-6 Upper Tracking Rate 3-6 Upper Sensor Rate 3-7 Programming considerations and restrictions 3-7 Rate limit 3-7 Possible atrial competition at high rates 3-8 Mean atrial rate 3-8
AV intervals 3-9
Overview 3-9 Selecting PAV and SAV 3-11
Rate Adaptive AV 3-12
Overview 3-12
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Programming for Rate Adaptive AV 3-12
RAAV operations 3-14
Programming considerations and restrictions 3-14
RAAV and sick sinus syndrome 3-14 Search AV and diagnostic 3-15
Overview 3-15
Programming to Adaptive AV 3-15
Adaptive AV operation 3-16
Suspension of Adaptive AV operation 3-17
Programming to fixed AV hysteresis 3-17
Fixed AV hysteresis operation 3-18
Programming considerations and restrictions 3-18
Recording AV interval adaptations 3-19 Blanking periods 3-20
Nonprogrammable blanking periods 3-20
Post-Ventricular Atrial Blanking 3-20
Ventricular Blanking 3-21
Single chamber atrial blanking 3-21 Refractory periods 3-21
Overview 3-21
Post-Ventricular Atrial Refractory Period 3-22
Sensor-varied PVARP 3-23
Determining sensor-varied PVARP 3-24
Automatic PVARP 3-24
Determining automatic PVARP 3-24
Programming restrictions for automatic PVARP 3-25
Spontaneous PVARP extension 3-25
Total Atrial Refractory Period (TARP) 3-25
Ventricular Refractory Period 3-26
Atrial Refractory Period (single chamber) 3-27
Noise reversion 3-27
Preventing noise sensing 3-29 High rate atrial tracking 3-30
Overview 3-30
2:1 block 3-30
Pacemaker Wenckebach 3-31
High rate operation in the DDDR mode 3-32
Table of contents
4. Lead / cardiac tissue interface
Implant Detection 4-2
Overview 4-2
Verifying lead connection during Implant Detection 4-3 Automatic polarity configuration 4-3
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Table of contents
Overview 4-3 Measuring lead impedance during configuration 4-3 How polarities are automatically configured 4-4 When automatic configuration is complete 4-6 Manually setting polarities 4-7 Programming interactions 4-7
Lead Monitor 4-8
Overview 4-8 How lead monitoring works 4-8
Lead impedance data 4-10
Automatic Lead Impedance (Chronic Lead Trend) 4-10 Clinician-selected Lead Impedance Detail 4-11 For further information 4-11
Capture Management and diagnostic 4-12
Overview 4-12 Initiating the pacing threshold search 4-12 The pacing threshold search 4-14 Automatic threshold adaptation 4-19 Programming interactions 4-23 Recording Capture Management data 4-23
Sensing Assurance and diagnostic 4-26
Overview 4-26 Monitoring sensitivity thresholds 4-26 Qualifying sensed events 4-27 Adjusting sensing thresholds 4-27 Programming considerations 4-28 Recording Sensing Assurance data 4-29
Manually selecting pacing parameters 4-31
Overview 4-31 Manually selecting pacing polarity 4-31 Muscle stimulation with unipolar pacing 4-31 Bipolar pacing polarity confirmation 4-32 Determining stimulation threshold at implant 4-32 Verifying stimulation threshold at follow-up 4-32 Selecting output parameters 4-33 For further information 4-33
Manually selecting sensing parameters 4-34
Overview 4-34 Manually selecting sensing polarity 4-34 Bipolar sensing polarity confirmation 4-35 Determining sensing threshold(s) at implant 4-35 Verifying sensing threshold(s) at follow-up 4-35 Selecting sensitivity settings 4-36
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Effects of myopotentials during unipolar pacing 4-36
For further information 4-37 Transtelephonic follow-up features 4-38
Overview 4-38
The Threshold Margin Test (TMT) 4-38
Threshold Margin Test operation 4-38
The Fully Automated Self Test (FAST) 4-39
FAST operation 4-39
Enhanced Transtelephonic Monitoring 4-41
For further information 4-41
5. Special therapy options
Mode Switch and diagnostic 5-2
Overview 5-2
How atrial tachyarrhythmia is defined 5-2
How atrial tachyarrhythmia is detected 5-3
Switching to non-atrial tracking mode 5-4
Switching back to atrial tracking mode 5-4
Mode switching interruption 5-5
Programming restrictions 5-5
Recording Mode Switch episode data 5-6 Non-competitive atrial pacing 5-8
Overview 5-8
How NCAP affects atrial timing 5-8
How NCAP affects ventricular timing 5-9
NCAP availability 5-9
For further information 5-10 PMT intervention 5-10
Overview 5-10
How the pacemaker defines PMT 5-10
Sensor corroboration before intervening 5-11
PMT therapy intervention 5-11
Automatic therapy suspension 5-12
Interactions with other features 5-12
Patient intervention for PMT 5-12
PMT intervention counter 5-12
For further information 5-12 PVC Response 5-13
Overview 5-13
How the pacemaker defines a PVC 5-13
Extending PVARP 5-13
Interaction with other features 5-14
PVCs automatically counted 5-14
Table of contents
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Table of contents
For further information 5-14
Ventricular Safety Pacing 5-15
Overview 5-15 How VSP operates 5-15
Sinus Preference and diagnostic 5-16
Overview 5-16 How Sinus Preference is defined 5-16 How Sinus Preference operates 5-17 Interaction with other features 5-18 Summary recording of Sinus Preference episodes 5-18 For further information 5-19
Rate Drop Response and diagnostic 5-20
Overview 5-20 How the pacemaker intervenes 5-20 How the drop detection option defines a specified rate
drop 5-21 How the low rate detection operates 5-22 Programming guidelines 5-22 Programming restrictions 5-24 Recording of Rate Drop Episodes 5-24
Sleep Function 5-26
Overview 5-26 How the Sleep Function works 5-26 Interrupting the Sleep Function 5-27 Programming considerations 5-27 Evaluating Sleep Function operation 5-27
Single Chamber Hysteresis 5-28
Overview 5-28 How hysteresis works 5-28 Programming considerations 5-29 Interactions with Sleep Function 5-29
6. Telemetry data
Establishing telemetry 6-2
For further information 6-2
Parameter summary 6-3
Overview 6-3 Parameters reported 6-3 Possible variation from programmed values 6-4 For further information 6-4
Patient information 6-5
Overview 6-5 Parameters reported 6-5
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Battery and lead information 6-6
Overview 6-6
Telemetered data 6-6
Conditions and variance in measurements 6-7
Chronic Lead Impedance Trend 6-7
For further information 6-7 Marker Channel telemetry 6-8
Overview 6-8
Standard Marker Channel telemetry 6-8
Therapy Trace telemetry 6-9 Intracardiac electrograms 6-10
Overview 6-10
Intracardiac electrogram recording 6-10
Uses for the Intracardiac Electrogram 6-11
For further information 6-12 Extended Telemetry 6-12
Overview 6-12
Extended Telemetry options 6-12
Additional battery drain 6-12
7. Miscellaneous operations
Magnet Mode operation 7-2
Overview 7-2
Magnet Mode operation 7-2
Threshold Margin Test 7-3
Transtelephonic Monitor feature 7-3
The Fully Automated Self Test (FAST) 7-3
Special operation with Extended Telemetry 7-3
For further information 7-4 Temporary programming 7-4
Overview 7-4
Temporarily programmable parameters 7-4
Temporary refractory period settings 7-5
For further information 7-5 Electrical reset 7-6
Overview 7-6
Partial electrical reset 7-6
Full electrical reset 7-7 Elective Replacement Indicator (ERI) 7-7
Overview 7-7
Basis for setting ERI 7-7
ERI verification 7-8 Emergency pacing 7-8
Table of contents
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Table of contents
8. Diagnostics
Introduction to diagnostics 8-2
Automatic diagnostics 8-2 Clinician-selected diagnostics 8-4 Battery and lead data 8-5 Suspending and clearing of data 8-5
Heart Rate Histograms 8-6
Automatic data collection 8-6 Retrieving the atrial and ventricular rate histograms 8-7 For further information 8-8
AV Conduction Histograms 8-8
Automatic data collection 8-9 Retrieving the AV Conduction Histogram 8-10 For further information 8-10
Sensor Indicated Rate Profile 8-10
Automatic data collection 8-11 Retrieving the Sensor Rate Profile 8-11 For further information 8-11
High Rate Episodes 8-12
Automatic data collection 8-12 Programmable data collection 8-14 How high rate episodes are defined 8-16 Limitation to detect high rate atrial events 8-17 Retrieving atrial and ventricular high rate diagnostics 8-17 For further information 8-17
Ventricular Rate Histogram During Atrial Arrhythmias 8-18
Automatic data collection 8-19 Refractory Sense Setup option 8-19 Retrieving Ventricular Rate Histogram During
Arrhythmias 8-19
Atrial Arrhythmia Trend 8-20
Automatic data collection 8-20 Retrieving Atrial Arrhythmia Trend diagnostics 8-20
Atrial Arrhythmia Durations 8-21 Remote Assistant 8-21
Programmable data collection 8-22 Retrieving Remote Assistant data 8-23 For further information 8-23
Custom Rate Trend 8-24
Data collection 8-24 Programmable data collection options 8-25 Retrieving Custom Rate Trend 8-25 For further information 8-25
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Key Parameter History 8-26
Automatic parameter value recording 8-26
Retrieving Key Parameter History information 8-26
For further information 8-26
9. Troubleshooting the pacing system
Troubleshooting strategy 9-2
Overview 9-2 Troubleshooting electrical problems 9-3
Defining electrical problems 9-3
Identifying the cause of an electrical problem 9-3
Correcting an electrical problem 9-5 Troubleshooting hemodynamic problems 9-6
Defining a hemodynamic problem 9-6
Identifying the cause of a hemodynamic problem 9-6
Correcting a hemodynamic problem 9-7 Handling, storage, and resterilization 9-8
Handling and storage 9-8
Resterilization 9-8 Pacemaker longevity 9-9
Background 9-9
Elective Replacement Indicator 9-9
Time from ERI to cessation of pacing 9-9
Distinguishing ERI from full electrical reset 9-9
For further information 9-10 Replacing the pacemaker 9-10
For further information 9-11 Patient information and service 9-11
Patient registration information 9-11
Establishing a patient record 9-11
Assistance information 9-12
For further information 9-12
Table of contents
A. Pacemaker description
Model number designator A-2 Radiopaque codes A-3 Physical dimensions A-4 Connector dimensions A-5
B. Preset parameter settings
Shipping settings B-2 Nominal settings B-7 Electrical Reset settings B-12 Emergency settings B-19
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Table of contents
C. Longevity projections
Longevity projections (normal operating life) C-2
Models K
DR
901/903/906, KDR801/803/806, and KD901/903/906
longevity projections C-2 Models K Models K Models K Models K
DR
921 longevity projections C-3
DR
931/933 longevity projections C-3
VDD
901 longevity projections C-4
SR
901/903/906 longevity projections C-4
Longevity projections (after ERI) C-5
ERI longevity projections for Models K KDR801/803/806, and KD901/903/906 C-5
ERI longevity projections for Model K ERI longevity projections for Models K ERI longevity projections for Model K ERI longevity projections for Models K
Elective Replacement Indicator (ERI) C-8 Battery specifications C-9
D. Telemetry and diagnostic values
Magnet Mode operations D-2 Telemetry functions D-3
Marker Channel and extended telemetry D-3 Electrograms (EGM) D-3 Battery and Lead Information D-4 Patient data D-5
Automatic diagnostics D-6 Clinician-selectable diagnostics D-9 Cardiac event counters D-12
DR
901/903/906,
DR
921 C-6
DR
931/933 C-6
VDD
901 C-7
SR
901/903/906 C-7
E. Parameter values and restrictions
Programmable modes and parameters E-2 Rate Response programming guidelines E-12 Timing reference E-13
Dual chamber timing summary E-16
F. Warnings and precautions
Special notice F-2 Warnings F-3
Programming and pacemaker operation F-3 Pacemaker dependent patients F-3
Precautions F-4
Programming and pacemaker operation F-4 Rate increases F-5 Unipolar sensing F-6
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Implantable defibrillator F-6 Potential complications F-8
G. Environmental interference
Hospital or medical environment interference G-2
Therapeutic diathermy G-2
Magnetic resonance imaging G-2
Electrosurgical cautery G-3
External defibrillation G-4
High radiation sources G-4
Lithotripsy G-4
Radiofrequency ablation G-5
X-Ray and fluoroscopy G-5 Home and job environment interference G-6
High voltage power transmission lines G-6
Communication equipment G-6
Commercial electrical equipment G-6
Home appliances G-6
Electronic article surveillance (EAS) G-7
Cellular phones G-7
H. Glossary
I. Index
Table of contents
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Table of contents
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Understanding Pacemaker Operation
Chapters 1 - 9 provide detailed information about the operation of the Kappa 900/800 Series pacemakers.
Pacing modes
Rate response
Pacemaker timing
Lead/cardiac tissue interface
Special therapy options
Telemetry data
Miscellaneous operations
Diagnostics
Troubleshooting the pacing system
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Pacing modes

This chapter provides information about the modes available with the pacemaker.
1
Introduction 1-2
Mode selection decision tree 1-4
Mode pertinency tables 1-5
Indications and usage 1-7
Contraindications 1-7
DDDR mode 1-8
DDD mode 1-9
DDIR mode 1-10
DDI mode 1-11
DVIR mode 1-12
DVI mode 1-13
VDD mode 1-14
AAIR / ADIR modes 1-15
AAI / ADI modes 1-16
VVIR / VDIR modes 1-17
Kappa 900/800 Series Pacemaker Reference Guide 1-1
VVI / VDI modes 1-18
AAT / VVT modes 1-19
DOOR / AOOR / VOOR modes 1-20
DOO / AOO / VOO modes 1-21
ODO / OAO / OVO modes 1-22
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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,
1
provides a simple
means of identifying pacing modes appropriate for given indications.
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.

NBG pacing codes

The pacemaker modes are defined in NBG Code.2 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 1-1 describes the first four letters of the NBG code.
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). Journal of the American College of Cardiology. 1991; 18: 1-13.
2
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.
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Pacing modes
Introduction
CHAMBER PACED
V = Ventricle
A = Atrium
D = Dual Chamber
S = Single Chamber
O = None
DDDR
CHAMBER SENSED
V = Ventricle
A = Atrium
D = Dual Chamber
S = Single Chamber
O = None
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
Figure 1-1. NBG pacing codes

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 “Rate response” on page 2-1, “Pacemaker timing” on page 3-1, and “Special therapy options” on page 5-1.
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Pacing modes
Mode selection decision tree
Mode selection decision tree
Figure 1-2 shows a basic decision tree used to select the pacing mode. In the shaded boxes the preferred mode or modes are listed and the alternate mode or modes appear below the dashed line.
Symptomatic
Bradycardia
(e.g., persistent
atrial fibrillation,
inexcitable atrium)
Is SA node conduction
presently adequate?
Ye s NoNo
AAI
DDD AAIR
DDDR
No
VVIR
VVI
Ye s
Can the atrium be sensed
and/or paced reliably?
Is AV conduction
presently adequate?
AAIR
DDDR
Figure 1-2. Mode selection tree
Ye s
No
Is SA node conduction
presently adequate?
Ye s
DDD
DDDR
VDD
(e.g., complete or transient AV block)
DDDR
DDIR
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Mode pertinency tables

Pacing modes
✓✓
✓✓✓ ✓✓
✓✓✓✓
✓✓✓✓
ibed in Chapter 4.
Mode pertinency tables
Table 1-1 and Table 1-2 show which pacing parameters and features apply to each pacing mode as indicated by black check
rate response is operative but not pertinent to basic mode operation. Note that certain features are not available in Kappa 800
marks. Dashes indicate parameters that are programmable when mode switch, RAAV, or sensor-varied PVARP are active or when
asynchronous modes are not shown in these tables.
Series pacemakers for certain pacing modes; see “Parameter values and restrictions” on page E-1 for specific details. Also,
Table 1-1. Pacing parameters available for each mode
✓✓✓✓✓✓✓✓✓✓✓✓
DDDR DDD DDIR DDI DVIR DVI VDD VVIR VDIR VVI VDI VVT AAIR ADIR AAI ADI AAT
a
Lower Rate ✓✓✓✓✓✓✓✓✓✓✓✓✓✓✓✓
Upper Tracking Rate ✓✓
Upper Sensor Rate ––✓✓ –––✓✓–––
Pacing Parameter
Paced AV Interval ✓✓✓✓✓✓
✓✓✓✓
b
Rate Adaptive AV ✓✓✓
PVARP
Atrial Refractory Period
Sensed AV Interval ✓✓
PVAB ✓✓✓✓
Atrial Blanking
✓✓✓✓✓✓
See Chapter 3 for descriptions of these timing parameters. Sensing Assurance and Capture Management are descr
Ventricular Blanking (after
AP)
Period
Ventricular Refractory
Sensing Assurance ✓✓✓✓✓✓✓✓✓✓✓
Sensor-varied PVARP is available in the DDDR, DDD, DDIR, and VDD modes. Automatic PVARP is available in the DDDR, DDD, and VDD modes.
Capture Management ✓✓✓✓✓✓✓✓✓✓✓
a
b
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Pacing modes
Mode pertinency tables
Table 1-2. Features available for each mode
✓✓✓ ✓✓
eatures.
DDDR DDD DDIR DDI DVIR DVI VDD VVIR VDIR VVI VDI VVT AAIR ADIR AAI ADI AAT
✓✓
a
a
a
Managing Ventricular
Managing Atrial Rhythm
Mode Switch ✓✓
Non-Competitive Atrial
Rhythm
Pacing
PMT Intervention ✓✓
Special Pacing
PVC Response ✓ ✓✓✓
Operations
Ventricular Safety Pacing ✓ ✓✓✓✓✓
Rate Drop Response ✓✓
Search AV ✓ ✓✓✓✓✓✓
Sleep Function ✓ ✓✓✓✓✓✓✓✓✓✓✓✓✓✓
Sinus Preference
Single Chamber Hysteresis
1-6 Kappa 900/800 Series Pacemaker Reference Guide
b
Rate Response
ADL Rate ––✓✓ –––✓✓–––
Rate Profile Optimization ––✓✓ –––✓✓–––
Activity Threshold ––✓✓ –––✓✓–––
See Chapter 5 for operational descriptions of special therapy options. Search AV is described in Chapter 3.
Activity Acceleration ––✓✓ –––✓✓–––
See Chapter 2 for operational descriptions of rate response f
Activity Deceleration ––✓✓ –––✓✓–––
a
b
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Indications and usage

Kappa 900/800 Series pacemakers are indicated for the following uses:
Rate adaptive pacing in patients who may benefit from increased pacing rates concurrent with increases in activity.
Accepted patient conditions warranting chronic cardiac pacing which include:
Symptomatic paroxysmal or permanent second or third-degree
Symptomatic bilateral bundle branch block.
Symptomatic paroxysmal or transient sinus node dysfunctions
Bradycardia-tachycardia syndrome to prevent symptomatic
Vasovagal syndromes or hypersensitive carotid sinus syndromes.
Kappa 900/800 Series 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.
Pacing modes
Indications and usage
AV b lock.
with or without associated AV conduction disorders.
bradycardia or some forms of symptomatic tachyarrhythmias.

Contraindications

Kappa 900/800 Series 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.
Unipolar pacing for patients with an implanted cardioverter­defibrillator (ICD) because it may cause unwanted delivery or inhibition of ICD therapy.
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Pacing modes

DDDR mode

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) or to change with intrinsic conduction times (Search 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) is a pacemaker­defined PVC and starts a new VA interval.
Sensor-indicated
Interval
A P
V P
Parameters:
Lower Rate = 60 ppm (1000 ms) PAV Interval = 200 ms PVARP = 280 ms
Sensor-indicated Rate = 90 ppm (667 ms)
A P
V S
SAV Interval = 170 ms
Sensor-indicated
Interval
A S
V S
A P
V P
Figure 1-3. Example of DDDR mode operation
1
The Total Atrial Refractory Period (TARP) may limit the tracking rate to a lesser value.
A S
V P
200 ms
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DDD mode

m
Pacing modes
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) or to change with intrinsic conduction times (Search AV).
A ventricular paced event may track an atrial sensed event up to the programmed Upper Tracking Rate.
A ventricular nonrefractory sensed event in the VA interval that is not
1
preceded by an atrial sense (AS or AR) is a pacemaker-defined PVC and starts a new VA interval.
Lower Rate Interval
A P
V P
Parameters:
Lower Rate = 60 ppm (1000 ms) PAV Interval = 200 ms
A P
V S
SAV Interval = 170 ms
Figure 1-4. Example of DDD mode operation
1
The Total Atrial Refractory Period (TARP) may limit the tracking rate to a lesser value.
A S
V S
Lower Rate Interval
200 ms
A P
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Pacing modes

DDIR mode

DDIR mode
o
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. If it is not inhibited, ventricular pacing occurs at the end of the PAV interval.
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 sensor­indicated rate. The following ventriculoatrial (VA) interval may be extended slightly to avoid an increasing atrial paced rate.
A ventricular nonrefractory sensed event in the VA interval starts a new VA interval.
Sensor-indicated
Interval
A P
V P
Parameters:
Lower Rate = 60 ppm (1000 ms) PAV Interval = 200 ms
Sensor-indicated Rate = 90 ppm (667 ms)
A P
Sensor-indicated
Interval
V P
Sensor-indicated
A S
V P
Figure 1-5. Example of DDIR mode operation
VA Interval
Sensor-indicated
Interval
A
A P
P
V P
200 ms
A P
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DDI mode

Pacing modes
DDI mode
The DDI mode provides dual chamber atrioventricular (AV) sequential pacing with atrial sensing but without atrial tracking.
Atrial pacing occurs at the Lower Rate. If it is not inhibited, ventricular pacing occurs at the end of the PAV interval.
An atrial event sensed outside the PVARP will inhibit a scheduled atrial stimulus but will not start an AV interval. Ventricular paced events after such sensed atrial events occur at the Lower Rate.
A ventricular nonrefractory sensed event in the ventriculoatrial (VA) interval starts a new VA interval.
Lower Rate Interval
A P
V P
Parameters:
Lower Rate = 60 ppm (1000 ms) PAV Interval = 200 ms
A P
Lower Rate Interval Lower Rate VA Interval
V P
Figure 1-6. Example of DDI mode operation
A S
V P
200 ms
A P
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Pacing modes

DVIR mode

DVIR mode
m
The DVIR mode provides AV sequential pacing at the sensor-indicated rate unless inhibited by ventricular sensed events.
Atrial pacing occurs at the sensor-indicated rate. If it is not inhibited, ventricular pacing occurs at the end of the PAV interval.
The DVIR mode ignores intrinsic atrial events. Sensing occurs only in the ventricle. A ventricular nonrefractory sensed event during the ventriculoatrial (VA) interval starts a new VA interval.
Sensor-indicated
Interval
A P
V P
Parameters:
Lower Rate = 60 ppm (1000 ms) PAV Interval = 200 ms
Sensor-indicated Rate = 90 ppm (667 ms)
A P
V S
Sensor-indicated
VA Interval
V S
Figure 1-7. Example of DVIR mode operation
Sensor-indicated
Interval
A P
V P
A P
200 ms
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DVI mode

Pacing modes
DVI mode
The DVI mode provides dual chamber AV sequential pacing without atrial sensing/tracking.
Atrial pacing occurs at the Lower Rate. If it is not inhibited, ventricular pacing occurs at the end of the PAV interval.
Sensing occurs only in the ventricle, and intrinsic atrial events are ignored. A ventricular nonrefractory sensed event during the VA interval starts a new ventriculoatrial (VA) interval.
Lower Rate Interval
A P
V P
Paramete rs:
Lower Rate = 60 ppm (1000 ms) PAV Interval = 200 ms
A P
V S
Figure 1-8. Example of DVI mode operation
Lower Rate VA Interval
V S
A P
V P
200 ms
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Pacing modes

VDD mode

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) is a pacemaker-defined PVC, and it starts a new V-V interval.
Lower Rate Interval
SAV
Interval
A S
V P
Paramete rs:
Lower Rate = 60 ppm (1000 ms) SAV Interval = 200 ms
Upper Tracking Rate = 120 ppm (500 ms) PVARP = 250 ms
A S
V P
Figure 1-9. Example of VDD mode operation
1
The Total Atrial Refractory Period (TARP) may limit the tracking rate to a lesser value.
1-14 Kappa 900/800 Series Pacemaker Reference Guide
A S
V P
A S
200 ms
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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 sensor­indicated 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 recordings and concurrent ECG, this mode may be used to observe the conducted ventricular rhythm without affecting atrial pacing.
Note: In the AAIR and ADIR modes, atrial refractory sensed events do not restart the Upper Sensor Rate interval.
Sensor-indicated Interval Sensor-indicated Interval
Pacing modes
AAIR / ADIR modes
A P
Paramete rs
Sensor-indicated Rate = 75 ppm (800 ms)
Upper Sensor Rate = 100 ppm (600 ms)
A R
:
Figure 1-10. Example of AAIR mode operation
A P
A S
A P
200 ms
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Pacing modes

AAI / ADI modes

AAI / ADI modes
The AAI mode provides single chamber inhibited atrial pacing. Sensing and pacing occur only in the atrium. Pacing occurs at the programmed Pacing Rate unless inhibited by sensed events.
The ADI mode operates the same as the AAI mode except that events sensed in the ventricle are recorded by the diagnostics. When used in conjunction with Marker Channel recordings and concurrent ECG, this mode may be used to observe the conducted ventricular rhythm without affecting atrial pacing.
Pacing Rate Interval
A P
Parameters:
Pacing Rate = 75ppm (800 ms)
A R
Pacing Rate Interval
A P
A S
Figure 1-11. Example of AAI mode operation
A P
200 ms
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VVIR / VDIR modes

The VVIR mode provides ventricular rate responsive pacing in patients for whom atrial-based pacing is deemed unnecessary or inappropriate. In the absence of sensed events, the ventricle is paced at the sensor-indicated rate.
The VDIR mode operates the same as the VVIR mode except that events sensed in the atrium are recorded by the diagnostics. When used in conjunction with Marker Channel recordings and concurrent ECG, this mode may be used to observe the underlying atrial rhythm without affecting ventricular pacing.
Note: In the VVIR and VDIR modes, ventricular refractory sensed events restart the Upper Sensor Rate interval.
Pacing modes
VVIR / VDIR modes
Sensor-indicated
Interval
V P
Paramete rs:
Lower Rate = 60 ppm (1000 ms) Upper Sensor Rate = 120 ppm (500 ms)
Sensor-indicated Rate = 90 ppm (667 ms) Ventricular Refractory Period = 300 ms
Sensor-indicated
Interval
V P
Upper Sensor
Rate Interval
V R
Sensor-indicated
Interval
V P
Figure 1-12. Example of VVIR mode operation
V P
200 ms
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Pacing modes

VVI / VDI modes

VVI / VDI modes
The VVI mode provides single chamber inhibited pacing at the programmed Pacing Rate unless inhibited by sensed events. Sensing occurs only in the ventricle.
The VDI mode operates the same as the VVI mode except that events sensed in the atrium are recorded by the diagnostics. When used in conjunction with Marker Channel recordings and concurrent ECG, this mode may be used to observe the underlying atrial rhythm without affecting ventricular pacing.
Pacing Rate Interval
V P
Paramete rs:
Pacing Rate = 60 ppm (1000 ms)
Ventricular Refractory Period = 300 ms
Figure 1-13. Example of VVI mode operation
Pacing Rate Interval
V P
V S
200 ms
V P
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AAT / VVT modes

Pacing modes
AAT / VVT modes
In the AAT and VVT modes, pacing occurs at the programmed Pacing Rate, but a nonrefractory sensed event triggers an immediate pacing output (rather than inhibiting such output). With the exception that pacing outputs occur when events are sensed, the triggered modes operate identically to the corresponding inhibited modes.
Note: Programmed triggered pacing will not occur faster than 300 ms (200 ppm) from the previous paced event. Temporary programmed triggered pacing is not limited to 300 ms (200 ppm).
Pacing Rate Interval
V P
Paramete rs:
Pacing Rate = 60 ppm (1000 ms)
Ventricular Refractory Period = 300 ms
V R
Figure 1-14. Example of VVT mode operation
Pacing Rate Interval
V P
T P
V P
200 ms
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Pacing modes

DOOR / AOOR / VOOR modes

DOOR / AOOR / VOOR modes
The DOOR, AOOR, and VOOR modes operate as follows:
The DOOR mode provides asynchronous AV sequential pacing at the sensor-indicated rate. Intrinsic events are ignored.
The AOOR and VOOR modes provide single chamber pacing at the sensor-indicated rate. Intrinsic events are ignored.
Sensor-indicated
Interval
A P
V P
Paramete rs:
Lower Rate = 60 ppm (1000 ms) PAV Interval = 200 ms
Sensor-indicated Rate = 90 ppm (667 ms)
Sensor-indicated
Interval
A P
V P
Sensor-indicated
Interval
A P
V P
Figure 1-15. Example of DOOR mode operation
Sensor-indicated
Interval
A P
V P
A P
200 ms
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DOO / AOO / VOO modes

The DOO, AOO, and VOO modes operate as follows:
The DOO mode provides AV sequential pacing at the programmed Lower Rate with no inhibition by intrinsic events.
The AOO and VOO modes provide pacing at the programmed Pacing Rate with no inhibition by intrinsic events in the applicable chamber.
In addition to being directly programmable, the DOO mode is the Magnet mode of the corresponding dual chamber modes, except for the VDD mode, which is the VOO mode. AOO and VOO modes are the Magnet modes of the corresponding atrial and ventricular single chamber modes, respectively.
DOO / AOO / VOO modes
Pacing modes
Lower Rate Interval
A P
V P
Paramete rs:
Lower Rate = 60 ppm (1000 ms) PAV Interval = 200 ms
Lower Rate Interval
A P
V P
Figure 1-16. Example of DOO mode operation
Lower Rate Interval
A P
V P
200 ms
A P
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Pacing modes

ODO / OAO / OVO modes

ODO / OAO / OVO modes
w
Warning: Never program these modes for pacemaker-dependent patients. For such patients, use the programmer’s inhibit function for brief interruption of outputs.
In the ODO, OAO, and OVO modes, sensing occurs in the designated chamber or chambers. When used in conjunction with Marker Channel telemetry and concurrent ECG, these modes may be used to observe underlying rhythms.
Blanking periods in these modes are automatically minimized to maximize the sensing window or windows. Thus, Marker Channel telemetry may display sense markers for cardiac events (for example, far-field R waves) that otherwise would not appear due to longer blanking.
No timing intervals or refractory periods are used.
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Rate response

This chapter describes how the pacemaker’s automatic rate response features operate and how to individualize rate response.
2
Introduction to rate responsive pacing 2-2
Preset rate response at implant 2-3
Rate Profile Optimization operation 2-5
Individualizing Rate Profile Optimization 2-9
Activity sensor operation 2-11
Manual control of Rate Profile Optimization 2-16
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Rate response

Introduction to rate responsive pacing
Introduction to rate responsive pacing
Rate response
The pacemaker may provide appropriate rate response for patients who require cardiac pacing support at both submaximal and maximal rates. To achieve appropriate rate response, the pacemaker provides activity sensor-driven pacing with rate response control at the submaximal and maximal rate ranges. Submaximal rates are moderate pacing rates obtained during typical daily activities, such as walking or daily chores. Maximal rates are rates at or near the upper rate obtained during vigorous activities.
The pacemaker provides appropriate rate response by employing the following operations:
Three programmable rates control the submaximal and maximal rate ranges: Lower Rate, ADL Rate (Activities of Daily Living Rate), and Upper Sensor Rate. The ADL Rate is equivalent to the average target rate that the patient achieves for moderate activities.
Independent control of rate response is provided in both the submaximal and maximal rate ranges.

Automatic features

For models implanted in a rate responsive mode, the pacemaker automatically enables rate response after implant and automatically adjusts rate response, if necessary, once each day.
During the first 30 minutes after implant, pacing occurs at the implanted mode but without rate response. 30 minutes after implant, nominal rate response operation is enabled.
Once each day, rate response is assessed and adjusted, if necessary, in the submaximal or maximal rate ranges. The assessment is based on comparing the pacemaker’s historical sensor-indicated rate profiles against a clinician prescribed target rate profile of the patient. If the rate profiles differ, rate response is adjusted slightly in the appropriate rate range, and the assessment is repeated again the next day.
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For further information

Refer to “Rate Profile Optimization operation” on page 2-5 for information on how the pacemaker optimizes rate response.
Preset rate response at implant

Overview

The pacemaker is shipped in the DDDR mode for dual chamber rate responsive models and the VVIR mode for single chamber rate responsive models. It effectively operates in a nonrate responsive mode— DDD for dual chamber models and VVI for single chamber models—until implant detection is completed, which is typically 30 minutes after implant. Thereafter, the pacemaker automatically enables rate responsive pacing. Consequently, no programming is required for nominal rate response operation.
Note: Rate response is enabled for other operations in nonrate responsive modes (e.g., DDD mode switching to DDIR).
Preset rate response at implant
Rate response

Three pacing rate controls

If customization of rate response is desired, three pacing rates are provided to control the submaximal and maximal rate ranges:
Lower Rate defines the slowest rate at which pacing occurs in the absence of a sinus rate or physical activity.
ADL Rate (Activities of Daily Living Rate) is the approximate rate that the patient’s heart is expected to reach during moderate exercise.
Upper Sensor Rate provides the upper limit for the sensor-driven rate during vigorous exercise.
Refer to “Rates” on page 3-2 for additional considerations when selecting pacemaker rates.
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Rate response
Preset rate response at implant

Independent control of submaximal and maximal rates

The pacemaker automatically assesses and independently adjusts, if necessary, rate response levels for both submaximal and maximal rate ranges on a daily basis using rate profile data. This operation allows the pacemaker to respond to changes in submaximal or maximal exercise levels without affecting rate response in the other rate range. This independent control is accomplished by comparing rate profiles of the patient’s sensor-indicated rates against a nominal or clinician prescribed target rate profile.
If the rate profile data indicates that sensor-indicated rates are higher than rates targeted for in the submaximal and/or maximal ranges, the pacemaker decreases rate response slightly in the respective range.
If rates are lower than targeted for, rate response is increased slightly.

Starting rate response immediately

In situations where the clinician wishes to start rate responsive pacing before the 30-minute implant detection period is completed, perform the following steps:
1. Program Implant Detection to “Off/Complete.”
2. Configure pace and sense lead polarities and Lead Monitor.
3. Verify that Rate Profile Optimization is On.
4. Verify the appropriate ADL Response, Exertion Response, Activity
Threshold, Activity Acceleration, and Activity Deceleration settings.

For further information

Refer to “Rate Profile Optimization operation” on page 2-5 and “Individualizing Rate Profile Optimization” on page 2-9.
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Rate Profile Optimization operation

Overview

When Rate Profile Optimization is programmed On, the pacemaker can adapt submaximal and maximal rate response levels once each day by comparing the patient’s current sensor rate profiles against a nominal or clinician prescribed target rate profile. This feature is intended to provide automatic and independent monitoring of rate response at both submaximal rates for daily patient activities, such as walking and daily chores, and at maximal rates for vigorous patient activities.
Optimization can be individualized to the patient’s activity levels. Refer to “Individualizing Rate Profile Optimization” on page 2-9.
Optimization can also operate in the background when a non-rate responsive mode is programmed. This can provide appropriate rate response to patient activity if rate response is needed later or for certain therapy features, such as mode switching to a non-atrial tracking rate responsive mode.
Rate Profile Optimization operation
Rate response

Submaximal and maximal rate control

The pacemaker maintains a linear relationship between the sensor input and the sensor-indicated rate in both the submaximal and maximal rate ranges. Optimization controls how rapidly and to what level the sensor­indicated rate increases and decreases in these two rate ranges. The three programmable rate controls [Lower Rate, ADL Rate (Activities of Daily Living Rate), and Upper Sensor Rate] define the rate ranges (see Figure 2-1).
Submaximal rates are moderate pacing rates achieved during typical daily patient activities. These rates are at or near the ADL Rate.
Maximal rates are rates at or near the Upper Sensor Rate achieved during vigorous activities.
Optimization also controls rate responsiveness for rates below the submaximal rate range (i.e., at or near the Lower Rate).
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Rate response
Rate Profile Optimization operation
30%
Submaximal
Rate
Range
Maximal
Rate
Range
20%
10%
Indicated % of Time
Lower
Rate
ADL Rate
Upper
Sensor Rate
Figure 2-1. Submaximal and maximal rate ranges

Optimization using rate profiles

Optimization of rate response occurs independently in both the submaximal and maximal rate ranges. Rate response to activity sensor changes is assessed daily based on the following rate profile data:
Sensor-indicated rate profile – An actual rate versus time distribution of the patient’s averaged sensor-indicated rates. Once each day, the pacemaker collects a daily sensor rate profile and cumulates the data into a monthly average. Both the daily and monthly rate profiles are assessed each day to determine if adjustments to rate response are required. The monthly sensor rate profile is automatically stored in the Sensor Indicated Rate Profile diagnostic.
Target rate profile – A programmable rate versus time distribution of the patient’s desired rates. The ADL Response and Exertion Response parameters define the percent of time the sensor-indicated rate is in the submaximal and maximal ranges, respectively.
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30%
20%
10%
Indicated % of Time
30%
20%
10%
Indicated % of Time
Daily Sensor
Rate Profile
Rate
Monthly Sensor
Rate Profile
Rate
Figure 2-2. Comparing rate profiles
Rate Profile Optimization operation
Rate response
C
o
m
p
a
r
e
e
r
a
p
m
o
C
30%
Tar ge t Rat e
Profile
20%
10%
Indicated % of Time
Rate

Daily optimization of rate response

Once each day, the pacemaker evaluates the percentage of time the sensor rate is in the submaximal and maximal rate ranges by comparing the daily and monthly sensor-indicated rate profiles against the target rate profile (see Figure 2-2). From this comparison, the pacemaker automatically adjusts rate response in the submaximal and maximal ranges, if necessary, based on the following criteria:
If the sensor rate profiles show a higher percentage of time spent pacing than the target rate profile, rate response for the pertinent rate range is set to be less responsive. Conversely, if a lower percentage of time spent pacing is profiled than targeted for, rate response is set to be more responsive (see Figure 2-3).
If the sensor rate profiles match the target rate profile or the daily and monthly sensor rate profiles contradict each other, no rate response adjustments occur.
The goal of this operation is to keep the patient’s sensor rate profiles equivalent to the target rate profile.
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Rate response
Rate Profile Optimization operation
30%
25%
20%
15%
10%
5%
Indicated % of Time
60-70
Lower
Rate
=
Target Rate Profile
=
Sensor Rate Profile
Less paced rates than targeted for:
rate response in the
maximal range will be
adjusted to be
more aggressive
Maximal
Rate Range
120-130
130-140
70-80
More paced rates than
targeted for: rate response
in the submaximal range
will be adjusted to be
less aggressive
Submaximal
Rate Range
80-90 90-100 100-110 110-120
ADL Rate
Figure 2-3. Optimizing rate response

Adaptations in Optimization operation

Upper
Sensor Rate
The pacemaker adapts rate response more rapidly for the first ten days after Optimization is first activated post-implant or after certain rate response parameters are manually reprogrammed (e.g., Lower Rate, ADL Rate, Upper Sensor Rate, ADL Response, or Exertion Response). The intent is to quickly match rate response to the target rate profile under these circumstances.
Optimization also adapts rate response more rapidly when the difference between the sensor rate profile and target rate profile is significant or when a need for less rate response is indicated.
Optimization is skipped on any day that a device interrogation or parameter programming occurs.
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Individualizing Rate Profile Optimization

Individualizing Rate Profile Optimization

Overview

For Kappa 900/800 Series pacemakers, the clinician can prescribe a target rate profile using the ADL Response and Exertion Response parameters to match the patient’s life-style or activity levels. The programmable ADL Response parameter alters the targeted rate distribution in the submaximal rate range, while the Exertion Response parameter alters the rate distribution in the maximal rate range. Optimization takes approximately one month to incrementally adjust rate response to match the individualized target rate profile.

Submaximal rate profiles

The nominal setting for the ADL Response parameter is “3-Moderately Active.” Programming a more active setting redefines the target rate profile to spend more time pacing at or above the ADL Rate, thereby increasing rate responsiveness in the submaximal rate range. Programming a less active setting redefines the rate profile to spend less time pacing at or above the ADL Rate, thereby decreasing rate responsiveness.
Rate response

Maximal rate profiles

The nominal setting for the Exertion Response parameter is “3-Moderately Frequent.” Programming a more frequent setting redefines the target rate profile to spend more time pacing near the Upper Sensor Rate, thereby increasing rate responsiveness in the maximal rate range. Programming a less frequent setting redefines the rate profile to spend less time pacing near the Upper Sensor Rate, thereby decreasing rate responsiveness.

Programming guidelines

If it is necessary to adjust rate response from the nominal setting, first verify that the three rate controls are appropriate for the patient. The Lower Rate should provide sufficient cardiac support at rest; the ADL Rate should be set for submaximal rate support during typical daily activities; and the Upper Sensor Rate should limit the rate during maximal
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Rate response
Individualizing Rate Profile Optimization
exertion. If these rate control settings are appropriate, the ADL Response and/or Exertion Response settings can then be adjusted based on the guidelines in Table 2-1.
Rate range Select settings
Submaximal or Moderate Rates
Maximal or High Rates Rate Response
a
If a higher Exertion Response setting has not produced the desired rate response, increase the ADL Response setting.
For more detailed programming guidelines, refer to Table E-12 and Table E-13, which list the targeted time spent pacing for the five ADL Response and Exertion Response settings.
Table 2-1. ADL Response and Exertion Response guidelines
ADL Response
Rate Response To o A g gr e s si v e
Rate Response To o L o w
To o A g gr e s si v e
Rate Response To o L o w
Lower Number (Less Active)
Higher Number (More Active)
Exertion Response
Lower Number (Less Frequent Exertion)
Higher Number (More Frequent Exertion)
a
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Activity sensor operation

Overview

Activity sensor based pacing is controlled by the following programmable parameters:
Activity Threshold determines the minimum intensity of detected physical activity to which the pacemaker responds.
Activity Acceleration and Activity Deceleration times control how rapidly the pacing rate changes in response to increased or decreased activity. One programmable Activity Deceleration setting, ”Exercise,” provides an extended deceleration period following prolonged exercise.
Note that Activity Threshold, Activity Acceleration, and Activity Deceleration are automatically set to shipping settings 30 minutes after implant or can be manually programmed.

How Activity Threshold influences rate

Activity sensor operation
Rate response
A piezoelectric crystal, bonded to the pacemaker circuitry, is deflected by physical motion. The activity sensor converts detected motion into electrical signals. The programmed Activity Threshold screens out activity signals below the selected setting. Detected sensor signals vary from patient to patient due to body structure, placement of pacemaker, and so forth. Only sensor signals whose amplitude exceeds the programmed Activity Threshold (as shown in Figure 2-4) are used in computing the sensor-indicated rate. The lower the Activity Threshold, the smaller the signal required to influence the sensor-indicated rate.
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Rate response
Activity sensor operation
Activity
Sensor
Output
Time
Activity Threshold = Medium/Low
Figure 2-4. Activity sensor signal (threshold set to medium/low)
Settings
High
Med/High
Med/Low
Low
Low
Med/Low
Med/High
High

Evaluating the Activity Threshold setting

Walking increases the pacing rate; sitting results in pacing at or near the programmed Lower Rate. Use Table 2-2 as a guide for selecting an appropriate setting.
Table 2-2. Activity Threshold guidelines
Programmable settings
Low Responds to most body activity, including minimal
Medium/Low Limited response to minimal exertion; responds to
Medium/High Limited response to moderate body movements and
High Responds to only vigorous body movements and
2-12 Kappa 900/800 Series Pacemaker Reference Guide
Typical rate performance
exertion.
moderate or greater exertion.
exertion.
exertion.
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Activity sensor operation
Rate response

How Activity Acceleration and Deceleration influence rate

Activity Acceleration and Activity Deceleration times control how rapidly the pacing rate changes in response to increased or decreased physical activity. One programmable Activity Deceleration setting, ”Exercise,” provides an extended deceleration period following prolonged exercise.
Activity Acceleration time is the time required to achieve approximately 90% of the difference between the current rate and a higher steady-state rate consistent with the current level of activity. Figure 2-5 shows a graphic representation of the acceleration curves at the onset of strenuous exercise.
Activity Deceleration time is the time required to achieve approximately 90% of the difference between the current rate and a lower steady-state rate consistent with the current level of activity. Figure 2-6 shows a graphic representation of the deceleration curves at an abrupt cessation of strenuous exercise.
Upper
Sensor
Rate
Activity Acceleration
Programmable Settings
15 Seconds
30 Seconds
Rate Range
Lower
Rate
210453
Time (Minutes)
60 Seconds
Figure 2-5. Activity Acceleration curves
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Rate response
Activity sensor operation
Upper
Sensor
Rate
Rate Range
Lower
Rate
Activity Deceleration
Programmable Settings
2.5 Minutes
5 Minutes
10 Minutes
6543210 78910
Time (Minutes)
Figure 2-6. Activity Deceleration curves
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Activity sensor operation
Rate response

Exercise Deceleration operation

Activity Deceleration programmed to “Exercise” extends the rate slowing period following an exercise episode, providing up to 20 minutes of rate deceleration. When it is programmed on, the pacemaker uses activity sensor data to detect periods of vigorous, prolonged exercise. At the end of such an exercise period, the pacemaker uses a longer deceleration curve for the central portion of the programmed rate range. The actual deceleration rate is determined dynamically based on the intensity and duration of exercise and the new level of activity. Figure 2-7 shows the composite deceleration curve that applies after the abrupt cessation of sustained exercise.
Upper
Sensor
Rate
Rate Range
Lower
Rate
5 Minute Deceleration Curve
Begins Exercise Deceleration
Ends Exercise
Deceleration
121086420 14161820
Time (Minutes)
Figure 2-7. Exercise Deceleration
5 Minute
Deceleration
Curve
22
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Rate response

Manual control of Rate Profile Optimization

Manual control of Rate Profile Optimization

Overview

As an alternative to automatic Rate Profile Optimization, a programmer assisted Exercise test can be used to manually set rate response for the submaximal and maximal rates. The Exercise test is used to immediately set rate response to certain levels. Rate response parameters remain set to their programmed values if Optimization is Off. When Optimization is On, it can adjust these parameters once each day.

Evaluate and program rate response

The Exercise test is used to evaluate the patient’s rate response and allow manual programming of two rate response control parameters:
ADL Setpoint (Activities of Daily Living Setpoint) determines the minimum sensor response to pace at the ADL Rate, which falls within the submaximal rate range.
UR Setpoint (Upper Rate Setpoint) determines the minimum sensor response to pace at the Upper Sensor Rate, which is at the upper limit of the maximal rate range.
Note: The programmed ADL Setpoint setting must be less than the UR Setpoint setting.
Refer to the Kappa 900/800 Series Pacemaker Programming Guide for programming instructions.
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Pacemaker timing

This chapter describes the programmable and nonprogrammable timing intervals that govern the operation of the pacemaker.
3
Rates 3-2
AV interva ls 3-9
Rate Adaptive AV 3-12
Search AV and diagnostic 3-15
Blanking periods 3-20
Refractory periods 3-21
High rate atrial tracking 3-30
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Pacemaker timing

Rates

Rates

Overview

The following programmable rates control timing in the pacemaker:
Normal operating rates:
Lower Rate
ADL Rate
Upper Tracking Rate
Upper Sensor Rate
Other operating rates:
Sleep Rate (for Sleep function)
Hysteresis Rate (for single chamber demand modes)
Sinus Preference Zone (for Sinus Preference)
Intervention Rate (for Rate Drop Response)
Additionally, rates calculated by the pacemaker are used for some operations. These are:
Sensor-indicated rate
Mean atrial rate
The other operating rates are described in “Special therapy options” on page 5-1 along with the functions that use them. The normal rates are described in this chapter.
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Pacemaker timing
Rates
A-A and V-V timing
A-A timing – In all modes that pace the atrium, the pacemaker times
from atrial event to atrial event (A-A timing). This timing method mimics a natural sinus rhythm, producing A-A intervals that are nearly equal, except when timing is interrupted by one of the following:
PACs in DDIR and DDI modes
PVCs in DDDR, DDD, DDIR, DDI modes (PVC Response operation)
A ventricular sensed event during the VA interval in the DVIR and DVI modes
An atrial refractory sensed event that triggers an NCAP extension
VA intervals vary due to adjustments by A-A timing operations in order to achieve sensor-indicated or lower rate operation in the presence of varying AV conduction.
V-V timing – In modes that do not pace the atrium (e.g., VDD or VDIR) or single chamber ventricular modes, the pacemaker times from ventricular event to ventricular event (V-V timing).
P
DDD
A
V
Paramete rs:

Lower Rate

The programmed Lower Rate defines the slowest rate at which pacing occurs during a mode’s basic operation. In rate responsive modes, in the absence of sensor-detected activity, the sensor-indicated rate is equal to the programmed Lower Rate.
Lower Rate Interval Lower Rate Interval
P
P
Lower Rate = 60 ppm (1000 ms) PVARP = 300 ms
PAV Interval = 200 ms Ventricular Refractory Period = 240 ms
SAV Interval = 180 ms
S
Figure 3-1. Example of Lower Rate operation
Kappa 900/800 Series Pacemaker Reference Guide 3-3
S
S
P
P
200 ms
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Pacemaker timing
Rates

Operating lower rate

Under certain circumstances, the programmed Lower Rate may be overridden by an operating lower rate that is higher or lower than the programmed value. The following rates may become the operating lower rate:
Switching from and back to atrial tracking mode (for Mode Switch)
Sinus Preference Zone (for Sinus Preference)
Sleep Rate (for Sleep function)
Intervention Rate (for Rate Drop Response)
Hysteresis Rate (for single chamber modes)
Threshold Margin Test Rate of 100 ppm
Magnet Mode Rate of 85 ppm
Elective Replacement Indicator Rate of 65 ppm

Selecting a Lower Rate

Program the Lower Rate to maintain adequate heart rates during periods of inactivity or during pauses in atrial rhythms in the DDDR, DDD, VDD, AAIR, ADIR, AAI, and ADI modes.
Note: In the VDD mode, atrial tracking near the Lower Rate may result in V-V intervals that exceed the Lower Rate interval. This is normal operation.
Lower Rates from 120 to 130 ppm are intended for pediatric patients. Lower Rates below 50 ppm and above 100 ppm are primarily intended for diagnostic purposes.
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Pacemaker timing
Rates

Sensor-indicated rate

The sensor-indicated rate is the basic pacing rate in all rate responsive modes (DDDR, DDIR, DVIR, DOOR, VVIR, VDIR, VOOR, AAIR, ADIR, and AOOR). It is determined by the pacemaker based on the sensor­detected level of patient activity and the programmed rate response parameters. The sensor-indicated rate will never be greater than the Upper Sensor Rate or less than the Lower Rate.
Sensor-Indicated
Interval
Sensor Sensor Sensor
P
DDDR
A
V
Parameters:
P
Sensor-Indicated Rate = 90 ppm (667 ms) PVARP = 300 ms
PAV Interval = 200 ms Ventricular Refractory Period = 220 ms
SAV Interval = 190 ms
P
S
Sensor-Indicated
Interval
S
S
Figure 3-2. Example of Sensor-indicated rate operation
In rate responsive modes, the sensor-indicated rate tracks the activity sensor, which is detected by the piezoelectric crystal sensor’s frequency and amplitude.
In dual chamber rate responsive modes, the sensor-indicated interval is the AS-AP or AP-AP interval.
In single chamber rate responsive modes, the sensor-indicated interval is the A-A or V-V interval. In these modes, sensor-indicated rate intervals start with a sensed or paced event in the chamber being paced.
P
P
200 ms
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Pacemaker timing
Rates

Sensor indicated rate effect on other intervals

The sensor-indicated rate is used to determine the values of certain other timing intervals. These intervals are:
Rate adaptive paced AV (PAV) interval
Sensor-varied PVARP (even in non-rate responsive DDD and VDD modes)
PVARP extension (sensor-corroboration before PMT intervention)

ADL Rate

The ADL Rate (Activities of Daily Living Rate) is the target rate which the patient’s heart rate is expected to reach during moderate exercise.

Upper Tracking Rate

The programmable Upper Tracking Rate is the maximum rate at which the ventricle may be paced in response to sensed atrial events in the DDDR, DDD, and VDD modes. Sensed atrial events below the Upper Tracking Rate will be tracked at a 1:1 ratio, but sensed events above the Upper Tracking Rate will result in pacemaker Wenckebach (for example, 6:5, 4:3, 3:2, or 2:1 block). The Upper Tracking Rate usually should be programmed to a value less than the 2:1 block rate. Refer to “High rate atrial tracking” on page 3-30 for details.
Upper Tracking Rate
DDD
S
A
V
P
S
Figure 3-3. Example of Upper Tracking Rate (Wenckebach) operation
3-6 Kappa 900/800 Series Pacemaker Reference Guide
Paramete rs:
Sensor-indicated Rate =
75 ppm (800 ms)
Upper Tracking Rate =
100 ppm (600 ms)
SAV Interval = 200 ms
P
200 ms
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Pacemaker timing
Rates

Upper Sensor Rate

In rate responsive modes, the programmable Upper Sensor Rate provides the upper limit for the sensor-indicated rate during physical activity, particularly during vigorous exercise. In the DDDR mode, the Upper Sensor Rate may be higher than, lower than, or the same as the Upper Tracking Rate.

Programming considerations and restrictions

ADL Rate – It is recommended that the ADL Rate be at least 10 ppm less
than the Upper Sensor Rate or 20 ppm greater than the Lower Rate. However, programming the ADL Rate above or below these limits is permitted.
Upper rates – Programming a combination of high Upper Sensor Rate and Upper Tracking Rate and a long refractory period may result in a shorter “sensing window.” Loss of sensing in such cases could result in competitive pacing (unless Non-Competitive Atrial Pacing is programmed On). See “Non-competitive atrial pacing” on page 5-8 for more information.
Programming the Upper Tracking Rate to a value greater than the Upper Sensor Rate permits the atrial rhythm to be tracked to a rate higher than the sensor-driven rate.
The Upper Sensor Rate and/or Upper Tracking Rate must be greater than the Lower Rate. The Upper Sensor Rate must be greater than the ADL Rate.

Rate limit

An internal circuit, independent of the pacing timers, limits single chamber atrial or ventricular pacing rates to 200 ppm (± 20 ppm) for most single component failures. For dual chamber modes, atrial and ventricular rates are limited independently to 200 ppm 20 ppm). The rate limit is automatically disabled during temporary pacing in the AAI, ADI, AAT, AOO, VVI, VDI, VVT, and VOO modes to allow high rate pacing for diagnostic or therapeutic purposes.
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Pacemaker timing
Rates

Possible atrial competition at high rates

At high sensor-driven rates in the DDDR and DDIR modes, sensor-driven pacing may approximate the intrinsic atrial rate, with some intrinsic atrial events falling into the PVARP. This could result in asynchronous pacing with the potential for competitive atrial pacing. Consider the potential for asynchronous pacing at high rates before selecting an Upper Sensor Rate, especially for patients known to be susceptible to induction of atrial tachyarrhythmias. Weigh the benefits of high rate sensor-driven pacing against the potential for competitive pacing.
Note: Use of the Rate Adaptive AV feature and sensor-varied or automatic PVARP can reduce the likelihood of the type of asynchronous pacing described above. In the DDDR mode, Sinus Preference and NCAP can also be considered.

Mean atrial rate

The mean atrial rate (MAR) is a running average of the atrial rate for use by the Rate Adaptive AV and automatic PVARP features. The average uses all A-A intervals (except AS-AP or AR-AP intervals). In order to respond quickly to rapidly increasing atrial rates, the average gives preference to shorter A-A intervals over longer intervals when calculating the MAR. Figure 3-4 shows how the MAR tracks an increasing intrinsic atrial rate.
Atrial Rate Increasing by 2 bpm/beat
200
180
160
140
120
Rate (bpm)
100
80
60
0 5 10 15 20 25 30 35
Figure 3-4. Increasing mean atrial rate
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MAR
Intrinsic Rate
Time (Seconds)
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AV intervals

Pacemaker timing
AV interval s

Overview

In dual chamber modes, the AV intervals determine the time between the occurrence of an atrial event and the scheduled delivery of a ventricular stimulus. Separate AV intervals for paced and sensed atrial events are available. The lengths of these intervals may be programmed to fixed values or (optionally) rate adaptive or therapeutically determined.
Paced AV Interval (PAV) – PAV follows an atrial pace in the DDDR, DDD, DDIR, DDI, DVIR, DVI, DOOR, and DOO modes. The PAV interval duration may differ from the programmed value due to one of the following operations:
Rate Adaptive AV
Search AV
Ventricular Safety Pacing
Non-Competitive Atrial Pacing
PAV
Interval
PAV PAV
P
PAV
Interval
P
DDD
A
V
P
P
Figure 3-5. Example of PAV interval operation
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Pacemaker timing
AV intervals
Sensed AV Interval (SAV) – SAV follows an atrial sensed event in atrial synchronous pacing modes (DDDR, DDD, and VDD). The SAV interval duration may differ from the programmed value due to one of the following operations:
Rate Adaptive AV
Automatic PVARP
Search AV
Wenckebach
For Wenckebach operation, the SAV is extended to avoid violation of the Upper Tracking Rate or the total atrial refractory period while tracking a fast intrinsic atrial rate.
SAV
Interval
S
SAV SAV
DDD
A
V
PP
Figure 3-6. Example of SAV Interval operation
SAV
Interval
S
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Pacemaker timing
AV interval s

Selecting PAV and SAV

When programming AV intervals, the general hemodynamic goal is to assure that, to the extent possible, left-atrial systole is completed before left-ventricular systole begins. To achieve this, the AV interval durations may be adjusted independently of each other.
To accommodate the difference in interatrial conduction times, the SAV usually should be programmed to a shorter duration than the PAV, typically 30 to 50 ms shorter. If an SAV greater than the PAV is selected, the programmer notes that this is not usual, but the selected values may be programmed if clinically warranted.
When the SAV is longer than the PAV, a V pace following an atrial sense will always occur after the full SAV, even when the sensor­indicated rate or Lower Rate interval expires first.
In certain patients, short AV intervals may be used as a prophylaxis for AV nodal or accessory pathway reentrant tachycardias in dual chamber modes.
AV intervals should be programmed to allow for normal AV conduction and ventricular depolarization in sick sinus patients.
Long PAV intervals (greater than or equal to 250 ms) should be used with caution. If intrinsic ventricular events occur and are not sensed, a long PAV may result in pacing into the ventricle’s relative refractory period, including the T wave, or loss of AV synchrony, which may precipitate retrograde activation of the atria with corresponding hemodynamic consequences and symptoms. Long PAV intervals may also result from some Search AV settings (see “Search AV and diagnostic” on page 3-15).
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Pacemaker timing

Rate Adaptive AV

Rate Adaptive AV

Overview

In the normal heart, AV conduction times tend to shorten as the heart rate increases and to lengthen as the heart rate decreases. The Rate Adaptive AV (RAAV) feature, available in the DDDR, DDD, DDIR, DVIR, DOOR, and VDD modes, mimics this physiologic response. When RAAV is programmed On, the pacemaker shortens AV intervals for atrial rates within a programmed rate range. This feature provides increased opportunity for atrial sensing, as follows:
Shortened SAV intervals increase the tracking range at fast atrial rates by shortening the total atrial refractory period (TARP) and increasing the 2:1 block rate. Refer to “Total Atrial Refractory Period (TARP)” on page 3-25 and “High rate atrial tracking” on page 3-30 for more information.
Shortened PAV intervals lengthen the atrial sensing window of the VA interval at higher sensor-driven rates.
Note: RAAV will not shorten PAV intervals to less than 30 ms or shorten SAV intervals to less than 10 ms.

Programming for Rate Adaptive AV

For RAAV operation, the SAV and PAV are programmed (as applicable) to the values desired for low rates. Three additional programmable parameters control how AV intervals are adjusted at higher rates:
Start Rate – RAAV operation of shortening SAV and PAV intervals begins at this rate.
Stop Rate – The shortest SAV and PAV occur at this rate and at all higher rates, up to the upper rate limits.
Maximum Offset – The maximum amount of time (in ms) by which the SAV and PAV intervals can be shortened.
The PAV minus the Maximum Offset gives the shortest PAV interval at the Stop Rate (e.g., 200 ms - 100 ms = 100 ms). Subtracting the Maximum Offset from the SAV gives the shortest SAV interval (e.g., 170 ms ­100 ms = 70 ms).
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240
220
200
180
160
140
120
100
AV Interval (ms)
80
60
40
20
Pacemaker timing
Rate Adaptive AV
Figure 3-7 shows how the SAV and PAV intervals are linearly shortened as the rate increases from below the Start Rate to above the Stop Rate.
Programmed PAV
Programmed SAV
R
a
t
e
R
a
t
e
A
d
a
p
t
A
d
a
i
v
e
P
p
t
i
v
e
A
S
V
A
V
Shortest PAV
(PAV - Max. Offset)
Shortest SAV
(SAV - Max. Offset)
0
50
80
Start Rate Stop Rate
100
Rate (ppm)
Parameters:
Programmed SAV = 170 ms Start Rate = 80 ppm Maximum Offset = 100 ms
Programmed PAV = 200 ms Stop Rate = 150 ppm
Figure 3-7. Rate Adaptive AV operation (DDDR Mode)
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150 180
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Pacemaker timing
Rate Adaptive AV

RAAV operations

Shortening of the AV interval(s) occurs when the appropriate rate exceeds the programmed Start Rate, as follows:
SAV – The mean atrial rate determines SAV adjustments. Because of how the mean atrial rate is calculated:
SAV adjustments will lag during rapid increases or decreases in intrinsic atrial rates.
The SAV is not adjusted for isolated events (PACs).
AS-AP or AR-AP intervals may affect the SAV value since these intervals are not used in the mean atrial rate calculation.
PAV – The sensor-indicated rate determines PAV adjustments.
The approximate difference between programmed SAV and PAV is maintained as the SAV and PAV intervals are adjusted.

Programming considerations and restrictions

Search AV – RAAV will adjust AV intervals in conjunction with Search AV.
Search AV will first determine the appropriate AV intervals and RAAV will further modify the AV intervals. Note that with RAAV On, the adaptive Search AV operation is limited to the RAAV minimum of 30 ms.

RAAV and sick sinus syndrome

If RAAV is activated for a sick sinus syndrome patient whose PAV and SAV have been programmed to promote AV conduction, consider the following:
The rate at which AV conduction is lost should not be too low (i.e., below 90 bpm).
Review of the AV Conduction Histogram diagnostic data may aid in appropriate programming of Start Rate and Stop Rate to maintain AV conduction as long as possible.
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Search AV and diagnostic

Overview

The Search AV feature is intended for patients with intact or intermittent AV conduction and is available in the DDDR, DDD, DDIR, DDI, DVIR, DVI, and VDD modes for dual chamber Kappa 900 Series pacemakers. The pacemaker searches for the patient’s intrinsic AV conduction time and adjusts the SAV and PAV intervals either longer or shorter to promote intrinsic activation of the ventricles and to track fast atrial rates. When Rate Adaptive AV is active, the pacemaker will also adjust the SAV and PAV intervals relative to the rate adaptive values.
Two methods for adapting AV intervals are available:
Adjusting the AV intervals adaptively as intrinsic AV conduction times vary.
Adjusting AV intervals at a fixed hysteresis value to sensed ventricular events.
Pacemaker timing
Search AV and diagnostic

Programming to Adaptive AV

Programming Search AV to “Adaptive” operation requires setting the Maximum Offset parameter. This parameter defines the maximum amount of time (in ms) that the operating SAV and PAV intervals can be lengthened.
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Pacemaker timing
Search AV and diagnostic

Adaptive AV operation

The pacemaker attempts to keep intrinsic conducted events in an “AV delay window” that precedes scheduled paced events. The AV delay window is set to promote intrinsic conduction of the ventricles, but end early enough to avoid fusion or pseudo-fusion beats if pacing is necessary (see Figure 3-8).
Previous 16 AV events, 8 or more VS events are within 15 ms of the scheduled VP, thus PAV and SAV are extended by 31 ms to promote intrinsic conduction.
PAV i s n o w 181 ms
Previous 16 AV events, 8 or more VS events occur 55 ms before the scheduled VP, thus PAV and SAV are shortened by 8 ms to limit long AV delays if ventricular pacing is needed.
Paramete rs:
DDDR SAV = 120 ms
Lower Rate = 60 ppm PAV = 150 ms
Sensor-Indicated Rate = 90 ppm Maximum Offset = 110 ms
Figure 3-8. Adaptive Search AV operation
To determine when intrinsic conducted events occur, the pacemaker assesses the 16 most recent AV conduction sequences that start with a nonrefractory atrial sense (DDDR, DDD, and VDD modes) or an atrial pace (DDDR, DDD, DDIR, DDI, DVIR, and DVI modes) and end with a ventricular pace or a nonrefractory ventricular sense.
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PAV i s n o w 173 ms
200 ms
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Search AV and diagnostic
Search criteria of AV conduction times – The measured AV conduction times are classified as either “too short” or “too long.”
Where too short means 8 or more of the last 16 ventricular sensed events occurred within 15 ms of the scheduled ventricular pace, or 8 or more of the last 16 ventricular sensed events failed to occur before the pace.
Where too long means 8 or more of the last 16 ventricular sensed events occurred more than 55 ms before the scheduled ventricular pace.
Resultant adjustment of SAV and PAV intervals – If AV conduction times are classified as too short, the pacemaker will lengthen the operating SAV and PAV intervals by 31 ms for the next 16 pacing cycles to promote intrinsic conduction. The maximum that the SAV and PAV can be lengthened is limited by the Search AV Maximum Offset parameter.
If the previous 16 AV intervals were lengthened and are now classified as too long, the operating SAV and PAV intervals will be shortened by 8 ms for the next 16 pacing cycles. Shortening of the SAV and PAV is limited by the programmed SAV and PAV values or the RAAV Maximum Offset parameter, if RAAV is On.

Suspension of Adaptive AV operation

If maximum extension of the SAV and PAV intervals is reached and the search criteria indicate that the AV intervals are still too short, the pacemaker will suspend all AV interval adjustments for 1 hour and reset the SAV and PAV intervals to the programmed or current RAAV values. Subsequent AV interval adjustments will be successively suspended at 2, 4, 8, and a maximum of 16 hours, provided the maximum AV interval length is indicated as too short.
When the search criteria indicate that the AV intervals are too long, the current suspension period is terminated and adjustments of AV intervals resume.

Programming to fixed AV hysteresis

Programming Search AV to a specific AV hysteresis delay (in ms) defines the amount of time the operating SAV and PAV intervals can be lengthened.
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Pacemaker timing
Search AV and diagnostic

Fixed AV hysteresis operation

The pacemaker modulates the AV intervals according to whether or not the previous AV sequence started with an atrial event and ended with a ventricular pace or sense.
If the AV sequence ended with a ventricular sense, the programmed SAV and PAV intervals for the next pacing cycle will be lengthened by the programmed fixed AV hysteresis delay value to promote intrinsic conduction.
If the AV sequence ended with a ventricular pace, the programmed SAV and PAV intervals are restored to the programmed or RAAV values for the next pacing cycle.
After any A to VS event, SAV and PAV are extended by 60 ms to promote intrinsic conduction.
SAV is now 180 ms
Parameters:
DDDR SAV = 120 ms
Lower Rate = 60 ppm PAV = 150 ms
Sensor-Indicated Rate = 90 ppm AV Hysteresis set to 60 ms
Figure 3-9. Hysteresis Search AV operation

Programming considerations and restrictions

Automatic PVARP – When automatic PVARP is active and Search AV is
set to Adaptive, the pacemaker will ignore conduction times that are the result of automatic PVARP shortening of the SAV interval.
Rate Adaptive AV – Rate Adaptive AV (RAAV) will adjust AV intervals in conjunction with Search AV. Search AV will first determine the appropriate AV intervals and RAAV will further modify the AV intervals. Note that with RAAV On, the adaptive Search AV operation is limited to the RAAV minimum of 30 ms.
PAV is n ow 210 ms
After any A to VP event, SAV and PAV return to programmed values to limit long AV delays if ventricular pacing is needed.
200 ms
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Pacemaker timing
Search AV and diagnostic
When RAAV is active between the RAAV Start Rate and Stop Rate, Search AV will use the operating rate adaptive SAV and PAV intervals when assessing and adjusting the AV intervals. At rates below the RAAV Start Rate or when RAAV is Off, Search AV will use the programmed SAV and PAV values.

Recording AV interval adaptations

AV interval diagnostics record data about AV operations for the Search AV feature. Also, you have the option to record detailed data about AV operations.
Automatic Search AV Histogram
Programming AV Search parameters automatically initiates recording of data by the Search AV Histogram diagnostic. This histogram shows the number of A-VS, VS from Search, and A-VP intervals versus rate. A histogram can be displayed or printed from the Data icon.
Detail AV Interval Histogram
You have the option to record detailed histogram data on AV intervals for the Search AV feature. The clinician-selected AV Interval Histogram shows the number of AS-VS and AP-VS intervals versus rate. (Refractory sensed events are not included.)
AV Interval Histograms record data about AV operations for the Search AV feature.
Clearing AV interval data
AV interval data is normally cleared by the pacemaker one hour after a programming session.
However, you can select the option to clear data immediately. Be sure to save the session data or print the episode report before ending the patient session.
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Pacemaker timing

Blanking periods

Blanking periods
Blanking periods disable sensing for a programmable or nonprogrammable interval. Signals that are blanked may originate in either chamber or from outside sources such as noise from muscle movement.
Note: Black bars indicate blanking periods.
12
P
DDD
A
V
34
P
1. Nonprogrammable Atrial Blanking
2. Programmable Post-Ventricular Atrial
P
Blanking
3. Programmable Ventricular Blanking
4. Nonprogrammable Ventricular Blanking
Figure 3-10. Example of dual chamber blanking operation

Nonprogrammable blanking periods

Immediately following a sensed or paced event in either chamber, sensing for that chamber is blanked for a nonprogrammable period that may vary from 50 to 100 ms. The actual duration of the blanking period is determined dynamically by the pacemaker, based on the strength and duration of the signal. Dynamic blanking prevents sensing the same signal twice, while minimizing total blanking time.

Post-Ventricular Atrial Blanking

The programmable Post-Ventricular Atrial Blanking (PVAB) period, used in the DDDR, DDD, DDIR, DDI, VDD, VDIR, and VDI modes, prevents sensing of ventricular paced events or far-field R waves on the atrial lead. Any ventricular event (paced or sensed) starts the PVAB, which is also the first portion of the Post-Ventricular Atrial Refractory period (PVARP). The PVAB is limited to values equal to or less than the programmed PVARP, except in VDIR and VDI modes where PVARP does not apply.
Note: PVAB is programmed to a value less than or equal to PVARP.
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Pacemaker timing

Refractory periods

Ventricular Blanking

The programmable Ventricular Blanking period, which follows an atrial pacing stimulus in the DDDR, DDD, DDIR, DDI, DVIR, and DVI modes, prevents ventricular inhibition or ventricular safety pacing due to sensing of the atrial stimulus on the ventricular lead (crosstalk). The Ventricular Blanking period also applies to the ADIR and ADI modes to prevent sensing of the atrial stimulation.
Long blanking periods (36 ms or greater) increase the possibility of unsensed ventricular events.
Long blanking periods used in conjunction with long PAV intervals (250 ms or greater) may result in pacing into the Twave when intrinsic ventricular events are blanked and not sensed. PAV values (200 ms or less) should reduce the possibility of Twave pacing. Long PAV intervals may also result from some Search AV settings (see “Search AV and diagnostic” on page 3-15).

Single chamber atrial blanking

The programmable single chamber atrial blanking period, used in the AAIR, ADIR, AAI, ADI, and AAT mode, prevents sensing of far-field R waves. It is started by a paced, sensed, or refractory sensed atrial event.
Note: Atrial Blanking must be programmed at least 50 ms less than the Atrial Refractory Period.
Refractory periods

Overview

A refractory period is an interval during which an intrinsic event sensed on a particular lead channel cannot start certain timing intervals. Each refractory period begins with a blanking period, during which no sensing occurs. During the unblanked portion of a refractory period, sensing occurs, but sensed events may not directly affect timing operations. Refractory periods are intended to prevent certain timing intervals from being started by inappropriate signals such as retrograde P waves, far­field R waves, or electrical noise.
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Pacemaker timing
Refractory periods
Though they may not start timing intervals, refractory sensed events are monitored by the pacemaker, and they affect the operation of PVC Response, Mode Switch, Rate Adaptive AV operation, automatic PVARP, Non-Competitive Atrial Pacing, and other features for which the periodicity or number of sensed events are pertinent. Refractory sensed events are included on Marker Channel recordings.

Post-Ventricular Atrial Refractory Period

The Post-Ventricular Atrial Refractory Period (PVARP) follows a paced, sensed, or refractory sensed ventricular event in the DDDR, DDD, DDIR, DDI, and VDD modes. It is intended primarily to prevent the sensing of retrograde P waves that might promote Pacemaker-Mediated Tachycardias (PMTs) in atrial tracking modes. In the DDIR and DDI modes, PVARP prevents atrial inhibition from retrograde P waves.
The first portion of the PVARP is the programmable Post-Ventricular Atrial Blanking period (PVAB). During the remainder of the PVARP, intrinsic atrial events may be sensed as refractory sensed events (AR) and identified on Marker Channel recordings, but they do not affect stimulus timing.
In the DDDR, DDD, and VDD modes, an SAV is not started.
In the DDDR, DDD, DDIR, and DDI modes, the scheduled atrial pace is not inhibited.
P
DDD
A
V
Figure 3-11. Example of PVARP operation
The duration of the PVARP may be selected as follows:
The PVARP should be programmed to a value greater than the patient’s ventriculoatrial (VA) retrograde time when retrograde conduction is present.
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PVARP
P
P
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Pacemaker timing
Refractory periods
Excessively long PVARPs may induce 2:1 block at high intrinsic rates in atrial tracking modes (DDDR, DDD, and VDD).
To reduce the 2:1 block point, PVARP can be set to vary based on the sensor-indicated rate (sensor-varied PVARP) or the mean atrial rate (automatic PVARP).

Sensor-varied PVARP

When sensor-varied PVARP is programmed, the pacemaker determines a value for the PVARP based on the sensor-indicated rate. The intended purpose of the sensor-varied PVARP depends upon the mode:
In the DDDR, DDD, and VDD modes, sensor-varied PVARP is intended to do the following:
Enhance protection against PMT at lower rates by providing
longer PVARPs at low sensor-indicated rates
Allow tracking of higher atrial rates (that is, provide a higher
2:1 block rate) by shortening the PVARP at high sensor-
indicated rates
In the DDIR mode, the sensor-varied PVARP is intended to promote AV synchrony by preventing inhibition of atrial pacing by an atrial sense early in the VA interval. It also reduces the likelihood of competitive atrial pacing at high sensor-indicated rates.
Upper
Sensor
Rate
Lower
Rate
400 ms 300 ms 400 ms
PAV PVARP PAV PVARP
200 ms
Figure 3-12. Sensor-varied PVARP operation (DDDR Mode)
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Refractory periods

Determining sensor-varied PVARP

The pacemaker determines the duration of the sensor-varied PVARP as follows:
In the DDDR, DDD, and VDD modes, the sensor-varied PVARP is limited to 400 ms at low rates and the programmed PVAB at high rates (as shown in Figure 3-12).
In the DDIR mode, the sensor-varied PVARP is approximately 400 ms at low rates and the programmed PVAB at high rates.
In the DDDR, DDD, DDIR, and VDD modes, the sensor-varied PVARP is automatically adjusted to maintain a 300 ms sensing window (as shown in Figure 3-12).

Automatic PVARP

When automatic PVARP is programmed, the pacemaker determines a value for the PVARP based on the mean atrial rate (which is an average of all A-A intervals except those starting with an atrial sense or atrial refractory sense and ending with an atrial pace). In the DDDR, DDD, and VDD modes, automatic PVARP is intended to provide a higher 2:1 block rate by shortening the PVARP and SAV (if necessary) at higher tracking rates and protect against PMTs at lower rates by providing a longer PVARP.

Determining automatic PVARP

The pacemaker determines the duration of the automatic PVARP as follows:
After every four pacing cycles, a 2:1 block rate is calculated that is 30 bpm above the current mean atrial rate.
PVARP is then adjusted so the total atrial refractory period equals the calculated 2:1 block rate. The programmable Minimum PVARP parameter controls the minimum value that PVARP can be shortened to.
If the minimum PVARP value is reached and the 2:1 block rate is still too low, the SAV interval can be shortened to increase the 2:1 block rate. The minimum SAV that can be set is the rate adaptive SAV value (i.e., the programmed SAV value minus the RAAV Maximum Offset value).
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Pacemaker timing
Refractory periods
The minimum adjustable 2:1 block rate is 100 ppm. The maximum adjustable 2:1 block rate is the Upper Tracking Rate plus 35 ppm. If Mode Switch is On, the maximum 2:1 block rate can be the Detect Rate if this rate is less than the Upper Tracking Rate calculation.

Programming restrictions for automatic PVARP

Rate Drop Response – When programmed On in the DDD mode,
automatic PVARP is not available.

Spontaneous PVARP extension

The programmed PVARP duration, the sensor-varied PVARP, and the automatic PVARP may be overridden by the PVC Response and PMT Intervention features, as follows:
When the PVC Response feature is programmed On and a pacemaker-defined PVC occurs, the PVARP is forced to 400 ms for one cycle if a lesser value is in effect.
When PMT Intervention is programmed On and a pacemaker­defined PMT is detected, the PVARP is forced to 400 ms for one cycle after the ninth paced ventricular event of the PMT.
Refer to “PMT intervention” on page 5-10 and “PVC Response” on page 5-13 for further details on the PMT Intervention and PVC Response features and their interactions with PVARP.

Total Atrial Refractory Period (TARP)

In dual chamber modes that sense in the atrium, the Total Atrial Refractory Period (TARP) is the sum of two intervals, as follows:
AV Inter va l – The AV interval begins with an atrial event and ends with a ventricular event. The first portion is a nonprogrammable blanking period. Its complete duration is determined as follows:
In the DDDR, DDD, and VDD modes, the PAV or SAV interval is the AV interval.
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Pacemaker timing
Refractory periods
In the DDIR and DDI modes, the AV interval starts with the first atrial sensed event in the VA interval or with an atrial pacing stimulus; it ends when the PAV expires, even when ventricular pacing is inhibited.
Post-Ventricular Atrial Refractory Period (PVARP) – The PVARP is described on page 3-22.
TARP TA RP
SAV + PVARP
SAV
PVARP
SAV
PVARP
Figure 3-13. Total Atrial Refractory Period
During atrial tracking, TARP = SAV + PVARP, and its duration determines the rate at which 2:1 block occurs. Refer to “High rate atrial tracking” on page 3-30 for more information.

Ventricular Refractory Period

The programmable Ventricular Refractory Period (VRP) follows paced, sensed, and refractory sensed ventricular events (including PVCs) in all dual chamber and ventricular modes that sense in the ventricle. The VRP is intended to prevent sensing of the T wave or a PVC. The first portion of the VRP is a nonprogrammable blanking period. A ventricular refractory sensed event affects pacemaker timing as follows:
Ventricular blanking and refractory periods restart in all modes.
In the DDDR, DDD, and VDD modes, the upper tracking rate interval, PVARP, and PVAB also restart.
In the VVIR and VDIR modes, the upper sensor rate interval restarts.
Note: In dual chamber modes, the VRP should be programmed shorter than the PVARP.
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Pacemaker timing
Refractory periods
P
DDD
A
V
P
Figure 3-14. Example of Ventricular Refractory Period operation
In dual chamber modes, a ventricular refractory sensed event does not affect a scheduled sensor-driven or lower rate atrial output. Thus, a sensor-driven atrial output pulse will initiate a PAV with a ventricular output pulse following, unless inhibited.
P
VRP

Atrial Refractory Period (single chamber)

The programmable Atrial Refractory Period (ARP) follows paced, sensed, and refractory sensed atrial events. The ARP is used in the AAIR, ADIR, AAI, ADI, and AAT modes. It is intended to prevent inhibition due to far­field R wave sensing. The first portion of the ARP is a programmable blanking period. The ARP should be programmed to a value long enough (150 ms or greater) to prevent far-field R wave sensing but short enough to ensure atrial sensing up to the programmed Upper Sensor Rate.

Noise reversion

When sensing occurs during the Atrial Refractory Period (ARP) or Ventricular Refractory Period (VRP), the refractory period (and its blanking period) are restarted. The operation associated with continuous refractory sensing in the ARP or VRP is called noise reversion. Multiple restarts of the ARP or VRP (continuous noise reversion) do not inhibit scheduled pacing. Pacemaker behavior during continuous noise reversion is as follows:
Pacing occurs at the sensor-indicated rate for all rate responsive modes (except VVIR and VDIR).
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Pacemaker timing
Refractory periods
Sensor Sensor Sensor
P
DDDR
A
V
Paramete rs:
Pacing occurs at the programmed Lower Rate for all non-rate responsive modes (including VVIR and VDIR).
On the ECG, noise reversion may be difficult to distinguish from loss of sensing, but Marker Channel recordings will show refractory sense markers when noise reversion occurs.
Sensor-Indicated Interval
P
R
R
P
Lower Rate = 60 ppm (1000 ms) Upper Sensor Rate = 120 ppm (500 ms)
PAV Interval = 200 ms Ventricular Refractory Period = 240 ms
PVARP = 300 ms PVAB = 200 ms
R
P
P
P
200 ms
Figure 3-15. Example of noise reversion in DDDR at sensor-indicated rate.
Note: Atrial sensing during the PVARP, or refractory period following an atrial paced or sensed event in the DDDR, DDD, DDIR, DDI, or VDD modes does not restart the refractory period. An atrial refractory sensed event, however, will start a short blanking period of 50 to 100 ms depending on the signal strength and duration of the atrial event.
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VVIR
V
Paramete rs:
Lower Rate
R R R R P
Sensor
P
Lower Rate = 60 ppm (1000 ms) Ventricular Refractory Period = 240 ms
Upper Sensor Rate = 120 ppm (500 ms)
Figure 3-16. Example of noise reversion in VVIR at lower rate.

Preventing noise sensing

Pacemaker timing
Refractory periods
Sensor
P
200 ms
Noise reversion may be caused by electromagnetic interference (EMI), myopotentials, excessively high output settings, or low sensitivity settings. When it has been identified, noise reversion usually can be reduced or eliminated by one of the following actions:
Reprogram sensitivity to a less sensitive setting (higher numerical value) or program Sensing Assurance to On, to monitor and if necessary, adjust the sensitivity value. Refer to “Sensing Assurance and diagnostic” on page 4-26.
Reprogram sensing polarity to bipolar polarity (if available).
Reduce the amplitude and/or pulse width in the same or opposite chamber.
Program Capture Management to Adaptive to monitor ventricular capture thresholds, and, if necessary, adjust amplitude and pulse width values. Refer to “Capture Management and diagnostic” on page 4-12.
Remove patient from EMI environment.
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Pacemaker timing

High rate atrial tracking

High rate atrial tracking

Overview

In the DDDR, DDD, and VDD modes, the fastest atrial rate the pacemaker can track is determined by the total atrial refractory period (TARP), which is the sum of the SAV and the PVARP. Pacemaker behavior at high atrial rates in these modes is determined by the relationship between the TARP and the interval corresponding to the Upper Tracking Rate. In the DDDR mode, the interval corresponding to the Upper Sensor Rate also must be considered.

2:1 block

When the intrinsic atrial interval is shorter than the TARP, some atrial events will fall in the PVARP and not be tracked. At the rate where this first occurs, ventricular tracking occurs only on alternate beats, and 2:1 block ensues. In the DDD and VDD modes, the ventricular pacing rate drops precipitously.
When sensor-varied PVARP or automatic PVARP is selected, the 2:1 block rate may occur at a higher rate during activity due to shortening of the PVARP and the SAV (automatic PVARP only), thus increasing atrial tracking.
When Rate Adaptive AV operation is selected, the SAV shortens at high atrial rates, shortening the TARP and raising the 2:1 block rate.
When the 2:1 block rate is less than the Upper Tracking Rate, the Upper Tracking Rate cannot be achieved.
In the DDDR mode, pacing at the sensor-indicated rate may prevent a precipitous rate drop at the 2:1 block point when activity is present.
For patients with a documented propensity for prolonged or sustained atrial fibrillation or flutter, the clinician can select Upper Tracking Rate, SAV, and PVARP values that induce 2:1 block at a desired rate (2:1 block rate = 60,000/TARP). Alternatives for controlling rates in these patients include use of the Mode Switch feature and DDIR mode pacing.
In the DDDR mode, atrial competition may occur if the Upper Sensor Rate exceeds the 2:1 block rate.
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Pacemaker timing
High rate atrial tracking

Pacemaker Wenckebach

When the 2:1 block rate exceeds the programmed Upper Tracking Rate, pacemaker Wenckebach may occur. When the intrinsic rate exceeds the Upper Tracking Rate, a pacing stimulus at the expiration of the SAV would violate the upper tracking rate. The pacemaker therefore extends the SAV until the upper tracking rate interval expires. Subsequent SAVs require greater extension, until an atrial event falls in the PVARP and is not tracked.
In the DDDR, DDD, and VDD modes, the result is normally a fixed ratio between atrial and ventricular rates (3:2, 4:3, and so forth).
In the DDDR mode, the pacemaker Wenckebach rate may be smoothed by sensor-driven ventricular pacing, thereby overriding the fixed ratio.
Figure 3-17 shows how pacemaker Wenckebach operation occurs in the DDDR, DDD, or VDD modes.
S
DDDR
A
V
Paramete rs:
Upper Tracking
Rate Interval
S
P
Sensor-Indicated Rate = 90 ppm (667 ms) PVARP = 300 ms
PAV Interval = 230 ms Upper Tracking Rate = 100 ppm(600 ms)
SAV Interval = 200 ms
Upper Tracking
Rate Interval
P
Upper Tracking
Rate Interval
SAV
Interval
S
P
S
P
Figure 3-17. Example of pacemaker Wenckebach operation
Sensor
P
R
P
200 ms
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Pacemaker timing
High rate atrial tracking

High rate operation in the DDDR mode

Table 3-1 summarizes how the total atrial refractory period (TARP), the Upper Tracking Rate (UTR) interval, and the Upper Sensor Rate (USR) interval may interact at high atrial rates in the DDDR mode.
Table 3-1. Upper rates interaction with TARP
Relationship Between TARP and Upper Rate Intervals
TARP > both USR and UTR intervals
USR interval > TARP > UTR interval
USR interval > UTR interval > TARP
UTR interval > both USR interval and TARP
a
Unless the Non-Competitive Atrial Pacing is On, see “Non-competitive atrial pacing” on page 5-8.
Wenckebach
Before 2:1
Block
no no yes
no no no
yes yes no
yes yes yes
Achieve Upper
Tracking Rate
Pote ntial
Atrial
Competition
a
a
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Lead / cardiac tissue interface

This chapter discusses programming and follow-up topics relating to the lead/cardiac tissue interface.
4
Implant Detection 4-2
Automatic polarity configuration 4-3
Lead Monitor 4-8
Lead impedance data 4-10
Capture Management and diagnostic 4-12
Sensing Assurance and diagnostic 4-26
Manually selecting pacing parameters 4-31
Manually selecting sensing parameters 4-34
Transtelephonic follow-up features 4-38
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Lead / cardiac tissue interface

Implant Detection

Implant Detection

Overview

Implant Detection is a 30-minute period, beginning at lead insertion, during which the pacemaker verifies that each lead has been connected by measuring lead impedance. After 30 minutes of continuous lead connection, the pacemaker completes Implant Detection and activates the following features (see Figure 4-1):
Operating polarity (automatic configuration occurs during Implant Detection)
Adaptive sensitivity settings (Sensing Assurance)
Rate responsive pacing, including adaptive rate profile optimization (Rate Profile Optimization)
Adaptive ventricular output settings for threshold management (Capture Management)
Adaptive AV interval selection (Search AV)
Diagnostic data collection
Lead Connection Verified
Implant
Leads connected
Figure 4-1. Implant Detection period
Implant Detection is available in all pacing modes and is turned on at shipment.
Note: Automatic polarity configuration does not occur during Implant Detection if the Lead Monitor parameter is programmed to Monitor Only before implant. Automatic configuration will take place if Lead Monitor is programmed to Adaptive before implant or remains set to its shipping setting of Configure.
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30 Minutes
Lead polarities confirmed
Rate Response enabled
Adaptive features activated
Data collection activated
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Verifying lead connection during Implant Detection

At the time of lead insertion, the pacemaker begins verifying that each lead is present by measuring the impedance of each pacing pulse. When a pace is delivered, the pacemaker determines if the impedance is within the acceptable range, which is programmable between 200 to 4000 ohms for both bipolar and unipolar configurations.
High impedance paces cause Implant Detection to reset.
Low impedance paces (and continuous sensing) are considered acceptable for the purpose of determining lead connection and configuring polarity.

Automatic polarity configuration

Overview

During Implant Detection, bipolar pacemakers automatically configure pacing and sensing polarities through the Lead Monitor feature. Bipolar pacemakers are shipped with the Atrial and Ventricular Lead Monitor set to Configure, enabling automatic polarity determination shortly after lead connection.
Lead / cardiac tissue interface
Automatic polarity configuration
1
Unipolar-only pacemakers are configured to unipolar pacing and sensing polarity at the time of manufacture and remain unipolar during the operational life of the pacemaker.

Measuring lead impedance during configuration

Bipolar pacemakers, using either bipolar or unipolar leads, automatically configure pacing and sensing polarities by measuring the impedance of each pace during the configuration period. (Lead Monitor must be set to Configure or Adaptive. See “Lead Monitor” on page 4-8.) Impedance measurement during configuration is as follows:
1
The acceptable maximum impedance limit for a valid lead (bipolar or unipolar) can be changed by programming the Notify If > (Greater Than) parameter, which is part of the Lead Monitor and is found under the programmed lead polarities. The minimum impedance limit of 200 ohms is nonprogrammable.
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Lead / cardiac tissue interface
Automatic polarity configuration
The pacemaker issues a bipolar pace and immediately checks the pace for high impedance.
If the pace is within range, it is considered an acceptable bipolar
pace.
If high impedance is found, the pacemaker immediately follows
the bipolar pace with a backup unipolar pace.
If a unipolar backup pace is issued, the pacemaker checks it for high impedance.
If the pace is within range, it is considered an acceptable
unipolar pace.
If high impedance is found, the pacemaker assumes a lead is not
attached and restarts Implant Detection.
Notes:
During polarity configuration, the pacemaker also detects low impedance paces but does not follow them with unipolar backup paces. To avoid possible loss of capture due to continuous low impedance pacing, the pacemaker sets unipolar polarity when 3 of 16 paces are detected as low impedance during the first phase of configuration (see “Initial Configuration Phase” on page 4-5).
If the pacemaker assumes a lead is not present (a high impedance unipolar pace is detected) in one chamber of a dual chamber pacemaker, Implant Detection will restart.

How polarities are automatically configured

Atrial and ventricular lead polarities are configured independently in dual chamber bipolar models, with the exception of Models K have fixed bipolar atrial sensing only.
Operating pacing and sensing polarities for bipolar pacemakers are configured automatically in two phases during Implant Detection. (See Figure 4-2.) During these phases the pacemaker continues to measure impedance as described above.
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VDD
901, which
Page 95
Implant Detection
Lead / cardiac tissue interface
Automatic polarity configuration
Implant
Leads Connected
Phase
5 Minutes
Lead polarities
configured
Confirmation PhaseInitial Configuration
30 Minutes
Lead polarities
Figure 4-2. Automatic configuration of bipolar models
Initial Configuration Phase – The pacemaker sets lead polarities five minutes after lead connection unless a high impedance unipolar pace has reset Implant Detection, a prevalence of low impedance bipolar paces has set unipolar pacing, or if continuous sensing has occurred.
The pacemaker sets initial polarities as follows:
The pacemaker delivers three asynchronous paces at magnet rate.
If at least two of the three paces are determined to be bipolar, the pacemaker remains set to bipolar polarity (with backup unipolar paces) for the Confirmation Phase.
If at least two of the three paces are determined to be unipolar, the pacemaker sets polarity to unipolar. Unipolar polarity becomes the operating polarity for pacing and sensing, and no Confirmation Phase is required.
confirmed
Note: If one of the asynchronous paces in a given chamber is a high impedance unipolar pace, the pacemaker restarts Implant Detection in both chambers. Polarity configuration restarts only in the affected chamber, however.
Confirmation Phase – Twenty-five minutes after initial configuration, the pacemaker confirms final operating polarity for leads configured bipolar in the Initial Configuration Phase. During this 25-minute Confirmation Phase, the pacemaker measure the leads for high and low impedance paces. If 8 of 16 paces (or the programmed number of paces out of sixteen) are out of range, the lead will automatically be reconfigured to unipolar polarity.
At the end of twenty-five minutes, operating polarity for leads detected as bipolar during the Initial Configuration Phase is determined as follows:
The pacemaker delivers three asynchronous paces at magnet rate.
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Lead / cardiac tissue interface
Automatic polarity configuration
If at least two of the three paces are determined to be bipolar, the pacemaker sets operating polarity to bipolar (or Adaptive operation if Lead Monitor was programmed to Adaptive prior to implant). See “Lead Monitor” on page 4-8.
If at least two of the three paces are determined to be unipolar, the pacemaker sets operating pace and sense polarities to unipolar.
Note: If a high impedance unipolar pace occurs in a given chamber at any time during the 25-minute Confirmation Phase, the pacemaker restarts Implant Detection in both chambers. Polarity configuration restarts only in the affected chamber, however.
Leads configured unipolar during the Initial Configuration Phase continue to operate in the unipolar configuration. If bipolar polarity switches to unipolar during the Confirmation Phase, the operating polarity remains unipolar with no additional confirmation through asynchronous pacing.
w
Warning: If, at implant, the setscrews, both tip and ring, for a 3.2 mm connector pacemaker are not properly engaged and all electrical contacts are not sealed, leakage between the tip and ring contacts may occur. Such leakage may cause the pacemaker to falsely identify a unipolar lead as bipolar, resulting in a loss of output. The same result could occur for all bipolar models if the electrical contacts were not properly sealed when using lead extenders or adaptors.

When automatic configuration is complete

Thirty minutes after lead connection, Implant Detection and automatic configuration are complete. If, after this time period, the leads are detached and lead polarity type is changed, automatic configuration and Implant Detection do not restart automatically at reinsertion. The clinician must reprogram Implant Detection to On/Restart, which automatically resets Lead Monitor to Configure.
The Lead Monitor feature (see “Lead Monitor” on page 4-8) monitors and reports on lead stability when Implant Detection and automatic configuration are complete. It is automatically set by the pacemaker as follows:
Bipolar models are shipped with Lead Monitor set to Configure. However, after Implant Detection ends, Lead Monitor is automatically set to Monitor Only for bipolar and unipolar configurations.
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Lead / cardiac tissue interface
Automatic polarity configuration
Bipolar models with Lead Monitor programmed to Adaptive before implant are set to Adaptive if polarity was determined to be bipolar. If polarity for these models was determined to be unipolar, they are set to Monitor Only.
Unipolar models are shipped with Lead Monitor set to Monitor Only and continue to operate at that setting both during and after Implant Detection.

Manually setting polarities

To manually program atrial or ventricular lead polarities at implant, the clinician first must “turn off” the Configure setting under Lead Monitor by choosing the Monitor Only setting instead. Implant Detection still provides the 30-minute detection period, followed by automatic feature and diagnostics activation, when the pacemaker is programmed manually.

Programming interactions

Programming Implant Detection to Off /Complete before completion of the 30-minute automatic polarity configuration period requires the clinician to manually program Lead Monitor and polarities. The pacemaker’s automatic features are activated when Implant Detection is turned off.
Manually programming Implant Detection to On/Restart restarts lead detection, polarity configuration (Lead Monitor is set to Configure), and automatic feature activation.
Initiating a programming session at any time during Implant Detection causes Implant Detection to be restarted.
While Implant Detection is in progress, the programmer is unable to run temporary tests and battery and lead measurements.
If a dual chamber pacemaker is programmed to a single chamber mode, only one lead is configured. If the mode is reprogrammed to a dual chamber mode, the clinician will need to change the Lead Monitor from Configure to Monitor Only or Adaptive for the unconfigured lead, and then program pace and sense polarity for it manually.
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Lead / cardiac tissue interface

Lead Monitor

Lead Monitor

Overview

The Lead Monitor feature measures lead impedances during the life of the pacemaker. When programmed to do so, Lead Monitor also enables the pacemaker to switch bipolar pacing and sensing to unipolar when bipolar lead integrity is in doubt. It also controls automatic configuration of lead polarities at implant. Lead Monitor is available in all pacing modes.
#
Caution: If the Lead Monitor detects out-of-range lead impedance, investigate lead integrity more thoroughly.

How lead monitoring works

The Lead Monitor feature monitors lead impedance of paced chambers, as defined by the mode, by measuring the impedance of each pacing pulse to see if it falls within the programmed impedance range for a stable lead.
The three programmable values under Atrial or Ventricular Lead Monitor are as follows:
Configure - provides automatic configuration of polarity (see “How polarities are automatically configured” on page 4-4).
Adaptive
monitors bipolar paces for high impedance and provides
unipolar backup paces when high impedance is detected.
switches pacing and sensing polarity from bipolar to unipolar
when the pacemaker detects a prevalence of high or low impedance paces (see Monitor Sensitivity parameter in Table 4-1). The Lead Monitor setting changes to Monitor Only when polarity switches.
provides automatic polarity configuration when selected prior to
implant.
Monitor Only - monitors either unipolar or bipolar paces to determine if they are out of range but does not switch polarity when an out-of-range lead is indicated.
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Lead / cardiac tissue interface
Lead Monitor
Lead Monitor is activated at lead connection, and it is automatically set to its operating value of Monitor Only or Adaptive at the end of Implant Detection. See “When automatic configuration is complete” on page 4-6.
When Lead Monitor is set to Adaptive or Monitor Only and a lead is determined to be out of range, the pacemaker issues a lead warning that appears on the programmer screen at the next interrogation.
Lead Monitor programmable parameters – The programmable parameters for the Lead Monitor feature are shown below.
Table 4-1. Programmable parameters for Lead Monitor
General Parameters Meaning
Atrial Lead Monitor Monitors lead impedance in the atrium; option to
Ventricular Lead Monitor Monitors lead impedance in the ventricle; option to
Notify If < (Less Than) Nonprogrammable minimum boundary for
Notify If > (Greater Than)
Monitor Sensitivity
provide unipolar backup paces and to switch from bipolar to unipolar polarity for an out-of-range lead; provides automatic configuration of polarity at implant.
provide unipolar backup paces and switch from bipolar to unipolar polarity for an out-of-range lead; provides automatic configuration of polarity at implant.
acceptable atrial and ventricular bipolar lead impedance. Fixed at 200 ohms.
Maximum boundary for acceptable atrial and ventricular bipolar lead impedance.
Number of high or low impedance paces out of 16 that define an out-of-range lead on each channel.
Lead Monitor should not be programmed to Adaptive for patients with implantable defibrillators. When a prevalence of out-of-range lead impedance paces is detected, the monitor automatically reprograms the selected lead(s) to unipolar polarity. Pacing in the unipolar configuration may cause the defibrillator either to provoke inappropriate therapy or to withhold appropriate therapy.
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Lead / cardiac tissue interface

Lead impedance data

Lead impedance data
Lead impedance data is recorded automatically. In addition, you may collect detailed daily information about lead impedance.
Automatic Lead Impedance (Chronic Lead Trend)
The automatic Lead Impedance diagnostic data is based on measurements taken every three hours for each chamber that is being paced. The maximum and minimum lead impedance are compared to initial values. If the difference between either value is approximately 30%, data will be added to the Chronic Lead Trend for the life of the pacemaker.
The following data is continuously updated:
Lifetime minimum impedance
Lifetime maximum impedance
High impedance paces
Low impedance paces
If the maximum number of high impedance paces or low impedance paces is reached, that value will remain until the data is cleared. All other diagnostic data collection will continue.
Note: If pulse width is programmed to a value greater than 1.0 ms, the reported lead impedance will be lower than the actual lead impedance. In this case, the correct lead impedance can be measured during a patient session by selecting the Battery and Lead Measurements option. Accuracy of lead measurements for the Lead Monitor Adaptive or Lead Monitor Only parameter is not affected by pulse width settings greater than 1.0 ms.
Note: Chronic Lead Trend data collection can be programmed Off. To display or print the data, select the Data icon.
4-10 Kappa 900/800 Series Pacemaker Reference Guide
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